Seeking Alpha
We cover over 5K calls/quarter
Profile| Send Message|
( followers)  

Novo Nordisk A/S (NYSE:NVO)

Q3 2010 Conference Call

October 27, 2010 7:00 AM ET

Executives

Lars Rebein Sorenson – President and CEO

Mads Krogsgaard Thomsen – EVP and Chief Science Officer

Jasper Brandgaard – EVP and CFO

Analysts

Peter Hugreffe – ABG

Henrik Simonsen – SEB Enskilda

Keyur Parekh – Goldman Sachs

Richard Vosser – JPMorgan

Eric Le Berrigaud – Raymond James

Martin Parkhoi – Danske Bank

Carsten Madsen – Carnegie Bank

Mark Dainty – Citi

Jacob Thrane – Standard and Poor’s

Operator

Good day ladies and gentlemen and welcome to the Novo Nordisk investor earnings conference call for the first nine months of 2010. For your information, this conference is being recorded. At this time I’d like to turn the conference over to your host today, Mr. Lars Rebein Sorenson. Please go ahead.

Lars Rebein Sorenson

Thank you very much and welcome ladies and gentlemen to today’s Novo conference call regarding our performance for the first nine months of 2010, the outlook for the year and a preliminary outlook for 2011.

I’m Lars Rebein Sorenson, the CEO of Novo Nordisk and as usual, with me I have our Chief Financial Officer Mr. Brandgaard, Mr. Krogsgaard, our Chief Science Officer and present also are our investor relations officers.

Today’s earnings release is available on our homepage novonordisk.com along with the slides that we’re using for the conference call. The conference is scheduled to last approximately one hour. As usual, we’ll start with the presentation as outlined on slide number two. The Q&A will begin in about 25 minutes. Please 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. For further information on the risk factors, please see the earnings release and the slides prepared for this presentation.

Also note that mentioned, this conference call is being broadcast live and a reply will be made available on Novo Nordisk’s website after the call.

Please turn to slide number four. We’re very satisfied with the performance in the first nine months of this year. Sales growth in the first nine months was 17 percent reported and 12 percent in local currencies.

The global sales growth is driven by the continued penetration of our modern insulin’s NovoRapid, Levemir and Victoza and a solid Victoza launch performance. From a regional perspective, the key grown drivers have been North American and international operations. With Victoza launch in Europe, North American and Japan, we are encouraged by the ongoing expansion of the GLO-1 product.

Within R&D, we are happy to announce the results for trials for Degludec and DegludecPlus. The second if five 3a trials with DegludecPlus and new ultra long basal insulin with bonus component has now been completed. This trial confirms that DegludecPlus improves long term glycemic control and reduces hypoglycemic in people with Type II Diabetes with compared to NovoMix 30.

The first of 12 phase three trials with Degludec ultra long acting basal insulin has also been completed. The trial results shows that Degludec has the potential to offer dosing flexibility without compromising its glycemic control or safety profile.

For liraglutide markets under the brand name Victoza we have two diabetes in early phase three of weight maintenance studies showed that people treated with liraglutide following an initial run in period of four to 12 months each, actually lost an additional six kilos compared to the placebo group.

In hemophilia, we have completed a phase one study with an ultra-long acting recombinant set of non-derivative that potentially allows once weekly or less frequent dosing. In addition, we have initiated a phase one study with a long acting recombinant set of eight derivatives.

Turning to financials, our gross margin improved 130 basis points to 80.8% during the first nine months of 2010. Operating profit grew 24% reported and around 15% local currencies.

We now expect sales growth in the range of 11% to 12% in local currencies compared to previously 9% to 10% and operating profit growth in local currency is not expected to be more than 15% compared to previous guidance of 12% to 15%.

And our preliminary plans for 2011 indicated close to 10% sales growth and a 10% to 15% operating profit growth, both in local currencies.

Turn to slide number five. Our portfolio of modern insulin’s continue to show strong performance overall. In the first nine months the portfolio of modern insulin were the main growth driver accounting for more than 60% of total sales growth in local currencies. Sales performance reflects the steady and durable penetration of our modern insulin in an expanding market.

Victoza sales reached $1.366 million Danish Kroner in the first nine months, representing 27% of the sales growth this year local currencies. Victoza sales grew 13% recorded and 9% in local currencies. Sales of our growth hormone therapy product, Norditropin, increased 6% local currencies, with all regions contributing to growth.

Novo Nordisk is the second largest company in the global growth hormone market with a 25% margin measured by volume.

Please turn to the next slide for an update on the regional spread. In the first nine months all regions contributed to growth measured in local currencies. North American contributed 60% share of growth measured in local currencies followed by international operations and Europe, and local currencies sales in North America increased 21%. Sales growth was driven by strong performance of the modern insulin’s and Victoza.

European sales grew 5% in local currencies driven by continued progress in the portfolio of modern insulin and solid performance of Victoza. Sales in international operations increased 15% in local currencies and here the main growth drivers were modern insulin’s primarily in China.

Sales growth in Japan continues to be impacted by a change in the underlying insulin market dynamics where growth of basal segment in particular, basal modern insulins have accelerated at the expense of the premium segment where Novo Nordisk has its strongest position.

In the United States, Victoza’s launch performance continues to be encouraging. We are now 38 weeks into the launch and Victoza has gain more than 35% of the GLP-1 market measured by total scripts. Since the launch of Victoza, the GLP-1 market has expanded measured both in volume and in value. In volume, the number of weekly prescriptions have grown more than 20% and value of the GLP-1 market now constitutes more than 4.2% of the overall diabetes market, up from 3.25 immediately prior to the Victoza launch.

Slide number eight. The Victoza launch in Europe is also solid. GLP-1 continues to increase its share of the diabetes care market and Victoza has gained a significant share of the GLP-1 market. More recently, the product has been launched in Italy.

Mads Krogsgaard Thomsen will give you an update on the development within our clinical pipeline.

Mads Krogsgaard Thomsen

Thank you Lars. Please turn to slide 9. I’ll start out with DegludecPlus, the fixed-ratio insulin Degludec and as part combination product that targets several important patient segments, one of them being the premium segment that constitutes 30% of Degludec’s use.

Within this segment Phase III target study with DegludecPlus in people with late stage Type II diabetes has now been completed as part of the BOOST program. The trial was conducted in three continents and had multiple end points with emphasis on Degludec safety, i.e., different measures of glycemic control and hypoglycemia.

Patients were randomized treatment with either DegludecPlus or NovaMix 30 twice daily for 26 weeks as add on to all extra diabetic therapy. DegludecPlus effectively improved long term glycemic control, achieving the primary objective of HbA1c non-inferiority with HbA1c decreasing by around 1.5% points to 7.1% in both arms.

Moreover, the study yielded a number of significant positive findings, thus in terms of glycemic control, the patients titration targets were achieved faster and fasting as well as mean plasma glucose levels were lower for the DegludecPlus group compared to the NovaMix 30 group.

Furthermore, the total daily insulin dose at study completion was lower in the DegludecPlus group than in the NovaMix 30 group. The rate of nocturnal hypoglycemia was statistically significant in reduced overall and by more than two-thirds during the night for DegludecPlus compared to NovaMix 30.

Participants treated with DegludecPlus gained on average slightly less weight than those in the comparative group. DegludecPlus demonstrated a good safety and tolerability profile and there were no apparent differences between the groups with respect to adverse events and standard safety parameters.

Please turn to slide 10. We’ve also completed the first Phase III Degludec study with focus on flexibility in day-to-day treatment. Thus, today’s basal insulins must be administered at the same time every day, implying that busy people, sporty people, kids, elderly etc. have to adjust their lifestyle to the treatment rather than the other way around which obviously would be more desirable from a quality factor perspective.

Based on this need, and piggy backing on the ultra- long half-life of Degludec, we designed a labeling study, seeking to show that Degludec would give them once daily at various dosing intervals was a safe and efficacious insulin glargine given that 24 hours according to the label.

The 26 week controlled Phase IIIa Degludec target study in Type II diabetes patients randomized the patients to one week treatment with either Degludec in the evening, Degludec in a regiment dosage regimen between 8 and 40 hours or insulin glargine given at 24 hour intervals according to the label.

For all three treatment groups insulin therapy was added to the existing oral anti-diabetic therapy if any. The primary objective of HbA1c non-inferiority to Degludec in the flexible dosing regimen compared to insulin glargine was confirmed with HbA1c decreasing by 1.3 percentage points to around 7.2% in both treatment arms. There was no difference in HbA1c between the Degludec arms.

In the once daily flexible dosing regimen, Degludec was consistently superior insulin glargine in lowering the plasma glucose level. A trend towards lower risk nocturnal hypoglycemia was observed in both groups of participants treated with Degludec compared to patients treated with glargine.

Degludec demonstrated a good safety profile and there were no apparent difference between the treatment groups with respect to precedent and safety parameters.

Based on the above results, Degludec’s ultra-long action profile has now paved the road for a dosing scheme that is more flexible than today’s insulins through allowing daily administration of insulin when it fits into the individual’s 24 hour life cycle without compromising safety or efficacy.

Please turn to slide 11. Shifting gears to GLP -1 therapies now, Liraglutide is now currently based on the Phase II obesity results published last year, in phase three for weight management in obesity. It is our belief that future pharmaceutical treatment in this field should be seen as adjuvant therapy to behavioral modification that must include dietary and exercise counseling.

To support this belief, the first Phase III study had a primary end point looking at the ability of Liraglutide to maintain a 5% weight loss in Liraglutide dieting. This study was double blinded placebo control trial of 56 weeks duration, investigating treatment with 3 mg Liraglutide daily as an adjunct to dietary counseling in obese people without diabetes, had already lost at least 5% body weight during the four to 12 week running period on the Liraglutide diet.

More than three out of four patients achieved a 5% weight loss during run-in and the mean weight loss for the participants in the remaining trial was approximately 6 kilograms during run-in. The trial randomized a total of 422 patients with an average body weight at initiation of approximately 100 kilograms.

Participants treated for one year with Liraglutide lost approximately 6 kilogram additionally compared to the placebo treated group who maintained a stable body weight during the study period. During the treatment period, beneficial effects were also observed on markers of metabolic and cardiovascular risk.

Liraglutide was generally well tolerated and the 56 week completion rate was 75% and 70% for Liraglutide and placebo groups respectively. Withdrawals due to adverse events were below 10% and similar between the two groups. Consistent with previous Liraglutide trials, the most common adverse events were related to the gastrointestinal system.

Please turn to slide 12. Moving now to hemophilia, our portfolio is one which has evolved very significantly over the last couple of years to the extent that we now have two Phase III, two Phase II and two Phase I programs ongoing.

Today, I’ll focus on the promising recent results from our long-acting Factor IX program. Using insomatic site-specific glycoPEGylation that provides release of the native protein human Factor IX, upon activation at the bleeding site, we’ve now completed the Phase one study with Hemophilia B.

The Phase I study showed the compound was well tolerated with a very long half-life in IV infusion once weekly or less frequently. Compared to other Factor IX molecules for which human data has been presented or published, the duration of action of the new molecule appears to be longer, and we’ve now conducted an end of Phase II meeting with the FDA.

Based on this, we expect to initiate the Phase III Hemophilia B program during the first half of 2011. Regulatory discussion with other agencies are however, still ongoing.

On another note, we likewise end of Phase II meeting on the ultra-fast acting Factor VIIa analog, NN1731 and similarly we expect Phase III initiation during the first half of next year for NN1731. Finally, using the described above, we’re developing in Phase I, long-acting Factor VIII compound for hemophilia A.

With the growth hormone, Nova Nordisk has finalized a single dose study in children with long acting growth compound incentive for once weekly dosing. The study showed a good safety and tolerability profile but this once weekly profile could not be achieved. Lars has thus decided to terminate the project.

Nova Nordisk has initiated finally a Phase IIa study with a recombinant fully-human monoclonal antibody to obtain principle in rheumatoid arthritis. Also, we have initiated a Phase I study with anti-IL 21 licensed last year from ZymoGenetics, a recombinant fully human hormone antibody for the treatment of rheumatoid arthritis.

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

Jasper Brandgaard

Thank you Mads. Please turn to the next slide. We’re satisfied with the financial results for the first nine months of 2010. The sales growth was 17% as reported and 12% in local currencies.

Growth was realized within both diabetes care and pharmaceuticals, and the primary growth contribution originated in the modern insulin and Victoza. The growth margin for the first nine months of 2010 increased to 80.8% compared to 79.5% in the same period of 2009.

This primarily reflects a favorable product mix impact due to increased sales of modern insulin and Victoza supported by a 40 basis points productivity impact from the currency development.

Total nonproduction related costs increased by 18% to just over $22 billion. This development primarily reflects the cost associated with the global launch of Victoza impacting sales and distribution costs and the ongoing Phase III programs for the next generation of insulins impacting the R&D costs.

Operating profit for the first nine months of 2010 increased by 24% to $14.5 billion or by around 15% measured in local currencies, reflecting the solid sales growth, increased gross margin, and a higher level of licensees.

Net financial showed a net expense of close to $1 billion in the first nine months of 2010, compares net expense of around $700 million in the same period 2009. The number of full time employees has increased 4% primarily with making expansion in the market in international operations.

Please turn to the next slide for an update on the current development. This slide shows the development of the U.S. dollar and the Japanese Yen versus the Danish Kroner. Further, the expected annual impact on operating profit of a 5% movement in our key foreign currencies and the current extent of hedging for the same currencies are illustrated.

During 2010 the average exchange rate of the U.S. dollar and the Japanese Yen versus the Danish Kroner have both been about the average levels of 2009. During the third quarter, we have seen the U.S. dollar depreciate significantly against the Danish Kroner, bringing the current exchange rate down to a level close to the average of 2009. Notably though, the current exchange rate for U.S. dollar remains above the level in the fourth quarter of 2009.

Please note that the positive impact of the high exchange rates during 2010 compared to 2009 on our operating profit to a large degree accounted by a loss on our Asian contracts which is protected in our net financials.

For the first nine months of 2010, the foreign exchange results was an expense of $800 million, primarily caused by losses on foreign exchange, hedging of U.S. dollar due to the appreciation versus the Danish Kroner in 2010 compared to the exchange rate prevailing in 2009.

Please turn to the next slide for the financial outlook for 2010. Nova Nordisk now expects sales growth in 2010 of 11% to 12% measured in local currencies. This is based on the expectation of continued market penetration for Novo Nordisk key strategic products within diabetes care including continued global roll out of Victoza and biopharmaceuticals, as well as the expectations of continued intense competition, generic competition to Nova Nord in the EU and the impact from implementation of health care reforms primarily in the U.S. and Europe.

Given the current level of exchange rate versus the Danish Kroner, the recorded sales is now expected to be around 5 percentage points higher and measured in local currencies.

For 2010 growth in operating profit is now expected to be more than 15% measured in local currencies primarily driven by increased expectations for sales. Given the current level of the exchange rate versus the Danish Kroner, the reported operating profit growth is now expected to be 10 percentage points higher than the one measured in local currencies.

For 2010, Nova now expects a net financial expense of around $300 million. The current expectations reflects expected losses of foreign exchange hedging contracts and a non-recurring income of approximately 1.1 billion Kroner related to the divestment of shares with ZymoGenetics.

The income related to the divestment of Nova shareholding in ZymoGenetics is exempt from tax charges under applicable Danish tax laws. Consequently, the effective tax rate for 2010 is now expected to be around 21.5%. This nonrecurring effect will be due to the effective tax rate in the fourth quarter of 2010.

Capital expenditures is now expected to be more than $3 billion in 2010, primarily related to investments in new insulin formulation and filling plant in China and a new refill filling device capacity in Denmark.

Expectations for depreciation, amortization, and impairment losses are now around $2.6 billion whereas free cash flow is now expected to be more than 14 billion Danish Kroner. The increase in the expected cash flow for 2010 is reflected in the announced expansion of the share repurchase program for 2010 with 1 billion to now 9.5 billion Danish Kroner.

With regard to the financial outlook for 2011, it is Nova Nordisk intention to provide detailed guidance on the expectations in connection with the full year release of financial results for 2010 which is scheduled for February 2, 2011.

At present, the preliminary plans for 2011 indicate close to 6% sales growth and 10% to 15% growth in operating profit, both measured in local currencies. The preliminary plans reflect expectations for continued solid penetration of the portfolio of modern insulin, continued global roll out of Victoza and progress for key products within biopharmaceuticals.

These preliminary plans also reflect expected generic competition into all anti diabetic products, an impact from health care reforms and continued intense competition within both diabetic care and biopharmaceuticals.

Due to an expected negative currency impact following the recent significant depreciation of Novo Nordisk’s main invoicing currencies, the reported sales growth for 2011 is expected to be around 2 percentage points lower than the growth measured in local currencies, whereas the reported operating profit growth is expected to be around 4 percentage point lower than the growth measured in local currencies.

The profit margin effect of foreign exchange hedging contracts deferred for income recognition in 2011 when the hedged operating cash flows will be realized is currently expected to be approximately neutral.

All of the above expectations are based on the assumption that the global economic environment will not significantly change the business conditions going forward during the remaining half of 2010 and in 2011, and the currency exchange rate, basically the U.S. dollar remains at the current level versus the Danish Kroner during the remaining half of 2010 and in 2011.

This concludes our presentation of the financial results. Lars will now moderate the Q&A session. Please note 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 Rebein Sorenson

Thank you very much gentlemen. And now, a note that his conference is being taped and a reply will be made available on our website. And operator.

Question-and-Answer Session

Operator

(Operator Instructions). Our first question for today comes from Peter Hugreffe from ABG. Please go ahead.

Peter Hugreffe – ABG

Hi, Peter Hugreffe. Thank you very much for taking my questions. Firstly, just a clarification for your 2011 guidance. If I look into history one could say your preliminary guidance has been rather conservative or you could say at a minimum level. Is that also the deal for your 2011 guidance or is there anything that has changed from that context? And then secondly, in terms of Degludec, Mads you had previously stated that most of the studies, at least of all the studies were powered for showing lower hypoglycemic events at a range of 25% to 30%. Is this also the case with this beginning study?

Lars Rebein Sorenson

Thank you very much. First question is on the 2011 guidance and then Mads can kind of take the Degludec question.

Well yes, I mean already been 14 months ahead of the closure of 2011. Obviously there are some uncertainties and we would like to be cautious as usual. The main issues that are impacting our cautious is of course the expectation of a continued penetration of our modern insulin, the continued roll out of Victoza.

Of course competition so nothing is given there. Then we have the headwind on health care reform full impact in the United States and health care reforms throughout Europe. We will see final generalization of branding in the United States. We’ve made certain assumptions, but if we take out the uncertainties, I would say it would indicate a guidance for 2011. [Audio Gap]

This one is an outlier in that regard inasmuch as this is a highly specific study designed for one single purpose, namely utilizing the long half-life of Degludec to prove the point that you can actually live a more flexible dosing scheme because of the ability to use the product maybe one day in the morning, one day in the evening, the day after, midday, whenever it fits into your lifestyle, even if you are forgetful or doing sports or whatever you’re doing.

So this particular trial is designed differently and that among other things includes the inclusion of the sulphonylurea into the study. So among BEGIN and BOOST trials, in only two cases have we included sulphonylurea, and why do we have 15 out of 17 studies without sulphonylurea?

Well the reason being that when you want to look for hypoglycemia, you want to have a level playing field, and the level playing field would mean that to compare one insulin against the other insulin and then you look for hypoglycemia rates in those two regimens.

What we have here is a compilation of which about half are taking sulphonylurea and that also means that the signal-to-noise ratio has been significantly blurred vis-à-vis hypoglycemia. So if you compare for instance to that Phase II study where issues were not limit, we had a hypo rate on Degludec of 0.6 per patient year and 1.1 for glargine per patient year.

In this study it was about 3, and that really reflects that we have a three to four-fold increase in the risk of hypoglycemia in the study and that it is indeed driven by the sulphonylurea use, so that we have blurred the signal to noise statistically in a way that does make it meaningful to measure hypoglycemia statistics.

Yes, we do see a reduction in nocturnal hypoglycemia even in the group where the dose was administered Monday, Wednesday, Friday, early in the morning and Tuesday, Thursday, Saturday and Sunday late in the evening, i.e. the patients on some days would have 40 hours between the dosing and on some days only eight hours because they had an overnight sleep. In spite of that, we actually saw a numeric reduction in nocturnal hypoglycemia.

So the short answer to your question is Peter, that most of the remaining studies, they are designed for hypoglycemia. Most importantly the ones that are of one year duration, because that allows us to take the A1C down to 7, which it was not quite there, and also including large number of patients so you can even go for statistical superiority on some of the sub groups of hypoglycemia and then inclusion of patients who are not taking sulphonylurea so they have a level playing field to measure hypoglycemia from.

Lars Rebein Sorenson

Thank you very much Mads. We’re glad that you can give us a long answer. Next question please.

Operator

Our next question comes from Henrik Simonsen from SEB Enskilda. Please go ahead. Hello, your line is now open. Please go ahead.

Henrik Simonsen – SEB Enskilda

Sorry, Henrik Simonsen from Enskilda, sorry. Two questions, Lars. We had two major events impacting on your business, short and long term last week and also on the share price quite significantly. I was wondering if you could add a little bit of comment to the Pfizer-Biocon, a similar agreement last Monday, what is most important, significant negative you would see come out of that if that were to come into the market sometime later?

Secondly, I was noticing in your slide pack this morning you had like 12% of patients on Victoza in U.S. coming from Byetta and now that Bydureon is pushed further out, I would assume some of the patients on Byetta have been kept on Byetta in anticipation off of getting on to Bydureon. Should we expect a pickup in patients diverting from Byetta on to Victoza, or could you comment a little bit on that, how you see that panning out in the U.S.?

Lars Rebein Sorenson

Let me start by reflecting a little bit on the announcement provided by Biocon. This in a way is nothing new to most of us on this call in the sense that there has always been an issue that at a certain point in time there would be patent run out on the modern insulins. Patents have run out on human insulins and we have been competing for years with the Biocon group in India and in other overseas markets in a number of years, and they have been, if I should be diplomatic and modestly successful in competing with us. They have a market share in India which is less than 10% based on their current capabilities.

Now having said that, obviously by partnering off with the world’s greatest pharmaceutical company, what they do get is they get market reach, they get market understanding in the key developed markets. But as we understand the current collaboration agreement, it is upon Biogen to do the clinical development and the regulatory approvals of eventual new modern insulin biosimilars in the developed markets and then of course, it’s still somewhat of a deficiency in the sense that they’ve not been so successful at doing so historically.

There are issues also, when we reflect on this of scope, Biocon as I mentioned has a relatively modest market share and modest capacity to be a real substantial player in big markets like Europe and United States. We would need to see a significant expansion of their capacity.

This is going to pose some execution risks in terms of expanding, manufacturing and doing it in a way which is quality wise and compliance wise acceptable to European and to American authorities. So we’ve got a name on the competitors, one of the competitors, but we have always anticipated that there will be competitors. We’ve always anticipated for instance Sanofi-aventis is going to defend their Lantus franchise, so they probably will be selling generic version of Lantus as well.

So there’s nothing really new in it for us. It only highlights the importance of the next generation of modern insulins that we have been working so hard on and that’s it was of course gratifying that we were able to at the same research took place to give the first data on these two compounds and adding to that that we are also working on a fast acting version of the rapid acting segment which is currently served by NovoRapid.

We are currently working on an even faster formulation which may actually offer a unique product when and if our patents which includes formulation patents for NovoRapid expires in 2017. So that was the comment on the Pfizer agreement.

With regards to uptick of Victoza as a result of the Bydureon postponement, one can of course speculate whether or not that’s going to have an impact. We have internally adjusted our internal targets which has been included in the guidance that we have given you to reflect the fact that we are not seeing competition come Bydureon.

However, we are not anticipating a larger shift rate than what you are seeing currently somewhere in the range of 10% to 15%. We’re hoping to expand the market and that’s what we’re working on. Obviously by not having a full force of Lilly and Amylin out there, that is going to be a more difficult task. So not major changes in terms of pick up and conversions.

Thank you very much Henrik. Next question please.

Operator

Our next question for today comes from Mick Reedy from Goldman Sachs. Please go ahead.

Keyur Parekh – Goldman Sachs

Hi, good afternoon. It’s actual Keyur Parekh from Goldman Sachs, and thanks for taking my question. I have two if I may. First, just following up on the previous question on the Pfizer-Biocon deal, you’ve obviously spoken about the lack of existing manufacturing – excess manufacturing capacity at Biocon, but Biocon obviously has spoken about them using the asset they received from Pfizer of about $200 million to $300 million to set up a new manufacturing capacity. On your estimates kind of, can you provide us with your perspective how much the world global insulin demand could CapEx spend of that amount provide.

And secondly, on the study for Liraglutide and obesity, you have suggested that the primary endpoint was maintenance of the weight loss. Can you help us understand how to think about the 6 kilo weight loss on Liraglutide versus placebo was kind of largely flat? Is that statistically non-inferior? It is statistically significant? How should we think about that? Thank you.

Lars Rebein Sorenson

Thank you very much. And Mads will prepare for the question on obesity. I’ll just make a sort of brief comment as much as I can on how Biocon anticipate to use the cash inflow they’ve got from the Pfizer deal. I would say that if you want specific answers on how that will enable them to service the global markets, you should, of course ask them.

But I would say though that we had previously, when we had been talking in more generic terms about their entry into this business, we’ve spoken about the very high capital cost of getting into the business, except by saying that in our estimations, if you want to have a sizeable operation, you need to invest somewhere between $300 and $500 million in off-stream manufacturing of active ingredients.

You need to have an investment of approximately the same size in downstream formulation and filling, and then finally either you make devices yourself or you have to partner and pay for the development of specific devices for your need. And then after that comes of course the clinical and regulatory approval of the product and launch.

So as you can appreciate, even though $200 million to $300 million is a lot of money, it is a far cry from enabling the Biocon to become a global player in one go. Next, [inaudible].

Mads Krogsgaard Thomsen

Well it’s important to notice that this study is not a classical regulatory obesity study. In that what we’ve done here is actually had a running period as I mentioned, in which people over max 12 weeks on the hypocaloric diet should lose at least 5% body weight.

More than 75% did so and they were then eligible for randomization of up to 56 weeks of treatment with either placebo in a blinded manner or Liraglutide. And essentially, 6 kilograms of weight was lost through randomization. That is, 106 kilos to 100 kilos, and a further 6 kilograms were lost during the treatment down to about 94 kilos. So in total people went 12 kilograms down in a time span of about a year and a quarter.

Now in terms of the weight loss for Liraglutide compared to a placebo, it was indeed highly statistically significant and the amount of 5% weight loss on top of the running period weight loss was more than two-fold that of the placebo group and the actual ratio for actually meeting a 5% baseline body weight loss was about four in favor of Lira.

So there were actually three composite primary endpoints. There was the body weight maintenance. There was the change from baseline and there was the proportion who lost at least 5%. And in each case the P value in favor of superiority had several knots in front of it before there was another digit.

Lars Rebein Sorenson

Thank you very much Mads. Next question, please.

Keyur Parekh – Goldman Sachs

Thank you.

Operator

Our next question for today comes from Richard Vosser from JPMorgan. Please go ahead.

Richard Vosser – JPMorgan

Hi, Richard Vosser from JPMorgan. Thanks for taking my questions. Firstly, getting back to Victoza and the impact of the delay to Bydureon. Just wondering if you could give us the details of what you think for 2010 your Victoza sales will be. I think previously you’ve spoken about $200 million. And then I think I’ve seen comment that you think you can reach blockbuster status by 2012. I think previously that was around about 2015. So if you could give us an idea of your new or updated long term expectations for Victoza that would be great.

And probably the second question also on Victoza, I was just wondering if you could help us with the split in terms of the U.S. and rest of world split yet with Victoza. The launch is obviously in Europe, looks as though they’re going pretty well, so I’m wondering if you could give us some help there. Thanks very much.

Lars Rebein Sorenson

Yes, thank you very much. Jesper, why don’t you kick off with the estimates for this year and perhaps reiterate your comment and predictions on when we believe that Victoza will become a blockbuster, and then we’ll revert to so sort of the numbers on the split between Europe and the U.S.

Jesper Brandgaard

Thank you. The delay in the approval of Bydureon, of course, gave us clarity in making predictions on the sales volume going forward for 2010 where we would be $700 million in sales in the third quarter and no significant pipeline getting involved in that number, have a clear indication of a sales for 2010 which is going to be slightly above 2 billion Danish Kroner.

And also having clarity on the U.S. market providing more than half of the value of overall Victoza sales, we now feel comfortable in saying that Victoza will develop in to a blockbuster product by 2012. Given predictions beyond development of Victoza over and beyond 2012, we’ll have to wait how the competitive situation is going to look in the years beyond 2012. But the blockbuster status by 2012 seems to be a safe indication now.

Lars Rebein Sorenson

So, thank you, Jesper. You actually answered both questions in one because you indicated there are about two-thirds of the sales is in the U.S. and approximately a third in Europe. So well done, two in one. Next question please.

Operator

Our next question for today comes from Eric Le Berrigaud from Raymond James. Please go ahead.

Eric Le Berrigaud – Raymond James

Yes, good afternoon. Two questions please. First, could you give us some regulatory and development update on the hemostasis portfolio? And mostly for the Factor XIII, when could we see some data and when do you expect the filing for this one? And also on the Factor VIII on data, whether we can see or read something in the course of next year? And the second question, do you already commit yourself to a new share buyback program for 2011 and would it be fair to assume a similar amount to the one seen in 2010?

Lars Rebein Sorenson

Thank you very much. The development dates for Factor XIII and Factor VIII filing and data and what are the next milestones that you are foreseeing in the next year, buyback expectations for next year.

Yes, well as regards, the pre-BLA i.e. Biologics License Applications, as we call it with the SEPA, that we have for Factor XIII, this is moving towards the later phases of preparation, i.e. doing all the process validation and the things that you need to have in good order before we submit.

So it is still our anticipation to submit in the first half of next year the Factor XIII shift for congenital deficiency. As you are aware, we are also doing the first half of next year, have proof of concept data for cardiac surgery for the C molecule.

Number VIII is still recruiting and it’s too early to give a precise indication of when the submission will be, but I can inform you that we targeting submission of the fast-acting Factor VII analogue in NN1731 that is destined to start Phase III also during the first half of next in advance of any potential infant, at least outside of Russia, in regards to Factor VII or factor analogs.

Eric Le Berrigaud – Raymond James

Any dates on when we’ll see data on Factor XIII to keep the profile and Factor VIII if any?

Lars Rebein Sorenson

Yes, the Factor XIII data will be announced at a homeostasis conference over the next 12 months. We think it’s very prudent that the data, which are very strong even though they compare to a strong controls, that they come out in advance of the launch so that he physicians know exactly what they have.

Eric Le Berrigaud – Raymond James

That’s great. Thanks much for the help.

Lars Rebein Sorenson

Yes, but the shares buyback expectations going forward?

Jesper Brandgaard

Yes, we’ve continued a policy of returning whatever excess cash we are generating to our shareholders over and beyond the just over 40% in net payout ratio that we return in terms of dividends. We have returned in the form of share repurchase program. And you’ve seen us when we get a nonrecurring cash flow like the ZymoGenetics cash flow, then we return that in the form of a share repurchase program.

So for 2011, although we haven’t yet had the discussion with our Board on the exact amount et cetera, I think it’s safe to assume that we will continue with a payout ratio in terms of dividends which is aligned to where we see the general pharma industry at a level of 40% plus and payout ratio, and then we will continue to combine that with an annual share repurchase program and the exact of that will be aligned with our expectation for cash flow, free cash flow generated in 2011 and we will announce that on second of February.

Lars Rebein Sorenson

Super. Thank you. Next question please.

Operator

Our next question for today comes from Martin Parkhoi with Danske Bank. Please go ahead.

Martin Parkhoi – Danske Bank

I also have two questions. First, with respect to cost margin, how close are we to developing a much better than you clearly expected, and also the pricing U.S. has been quite handsome to you. What kind of impacts should we expect from the gross margin for 2010 to 2012 just for Victoza alone, everything else being equal?

And the secondly, now we’ve seen of course a set back with Tesko [ph] and the delay of Bydureon, and even you have failed with the long-acting growth hormone. Has that put any thoughts into your mind what the once weekly Victoza and Liraglutide?

Lars Rebein Sorenson

Thank you very much Martin. Yes, gross margin predictions of what impact Victoza is going to yield given the pricing situation and given the handsome launch and how that is impacting on our margins right now and Mads, any thoughts on long acting versions of proteins.

Jesper Brandgaard

Martin, where we’ve given quite clear guidance in terms of how our gross margin will develop this year and I think the guidance we’re giving on the underlying improvement in the ball park of 100 basis points is still one that you can safely toss for 2010.

We are guiding to the level of 50 to 100 basis points in effect for 2011 and we still think that is a relevant one. We certainly have a more positive impact from higher mix impact from higher sales of Victoza. On the other hand, as Lars alluded to in his review, the impact from U.S. health care reform is also slightly bigger than what we previously anticipated.

And then making statements about 2012 is getting tricky in terms of the impact on gross margin as a number of factors are influencing that, but saying currencies are the same and assuming no significant additional impact from health care reforms, I think it would be safe to say we look at 2012 that we would have a high probability of being able to continue to expand our gross margin ball park of 50 to 100 basis points also in ‘12, everything else being equal, but it is a lot of equals that has to stay the way they are, and it’s probably not going to be that good, but that’s the best outlook I can give you.

Martin Parkhoi – Danske Bank

Thank you very much. Then Mads, your thoughts on long acting proteins as opposed to very efficient daily administration.

Mads Krogsgaard Thomsen

Yes, well Martin, excellent question. Now you mentioned three. You mentioned Tesko [ph] by Bydureon and our own long acting growth hormone. They’re actually very different cases so you can’t generalize here. In terms of Tesko [ph], this was actually protein with a build-in on natural amino acids put into a sustained released combination that stayed under the skin for more than one week.

Together, that created a hypersensitivity problem and also some GI side effects. So that’s a specific test proofing. Then by Bydureon, it was to my knowledge two other factors that came into play in the complete response data. One was some clinical safety concerns i.e. the QTc testing demand from FDA and the other one was a CMC concern, i.e. that they had done DURATION-1 study with the pilot scale formulation and not a commercial scale formulation. So those are Bydureon specific issues.

And if you look at our long action grown hormone preparation, it was a PEGylated version. But what actually happened here is that in the kits where we’ve just finished the study, we were simply not able at the clinically relevant doses to document as we had previously done by the way in adults, then we actually had indeed week long elevations of the biomarker IGF-1.

Henceforth, we didn’t meet the target product profile so that failed for a third reason. So Martin, you know you cannot generalize as to what a once weekly test is, but I would concur with my boss, Lars, that when you have a once daily product such as Victoza that doesn’t rely on sustained release technologies and does include unnatural amino acids, you’re at least having a pretty safe effect.

Lars Rebein Sorenson

Thank you very much Mads, I really appreciated that. Next question.

Operator

Our next question for today comes from Carsten Madsen with Carnegie Bank. Please go ahead.

Carsten Madsen – Carnegie Bank

Thank you very much. This is Carsten from Carnegie. Just a couple of questions here. If you look at the underlying market growth in the U.S. diabetes market and that is excluding Victoza, it seems that the growth is slowing a bit down. Could you give us a couple of comments on that and how you plan to attack this?

Secondly, if we look at the Victoza, the patients are coming from, 20% of patients are coming from insulin. The way you mentioned today, giving the strong launch and significant numbers we probably reach in 2011, what do you think the impact will be on your insulin analog and human insulin franchise from the strong Victoza launch. Thanks.

Lars Rebein Sorenson

Thank you very. I’d prefer Mads if you would comment on the insulin situation first, and then we’re going to revert with our comments to the U.S. growth perspective and diabetes exclusive of the GLP1 segment.

Mads Krogsgaard Thomsen

Insulin switch is a complicated matter and somewhat hazardous enterprise. I think it’s very important to notice here that the reason why people add GLP-1 therapy to insulin is not to discontinue therapy, rather what they do is they load instant consumption somewhat, i.e. equipment to the GLP-1 that is substituting for that insulin and the benefits gained being less hypoglycemia and less weight gain benefits.

So what we’ve seen is not a switching but purely the effect that people have instant sparing effect of adding the GLP-1. If you consider the sheer volumes of patients that today are on instant therapy, and the fact that they have not switched, but rather have an instant sparing effect, this is a rather minute thing we’re talking about

Lars Rebein Sorenson

Thank you very much Mads for that clarification. And then as regards to the U.S. growth in the insulin market, so excluding Victoza, our analysis indicates it is relatively stable and it’s relatively high. It’s around 6.5% to 7% throughout, and we’re talking here net numbers for the last 12 months, so there’s no change as far as we can see.

Thanks. Next question please.

Operator

Our next question for today comes from Mark Dainty from Citi. Please go ahead.

Mark Dainty – Citi

Thank you. Just two questions. Firstly on Victoza, what is the percentage of prescriptions that come from primary care physicians or general practitioners and do you have any plans to try and increase that? And the secondly, on the withdrawal of human insulin from the market in the U.K., could you just give us an update as to how that’s going, what volume you may have lost to competitors and what the initial feedback is from governments and regulators.

Lars Rebein Sorenson

Yes, thank you very much. To the first question deals with how much is script coming from PCP and from Endo’s in the United States. It’s about two- thirds coming from the PCP’s and one-third which is coming from the endo. It is obvious from our launch plans that we are starting with the endo’s and we are in the position right now where we are working with managed care for organizations to have a similar tier as Byetta, meaning that the products are not necessary to have trial authorization.

That is a question of rebate and negotiations with managed care in the U.S. When we launched the product, we did not offer any rebate. We are now negotiating with managed care to change pricing status with these organizations and that should benefit prescribing from the PCP’s going forward. If the PCP’s are lastly attest to these managed care organizations.

And the second question was the withdrawal of human insulin in the U.K. Obviously withdrawal of products in the insulin market is always met with apprehension on the part of the patients and this also shows how conservative the insulin market is, very unlikely to change, and therefore when we do a withdrawal, we usually try to announce this very long time perspectives.

We try to deal with the authorities to make the withdrawal in a safe fashion. We deal with patient association and then we get the withdrawal done with as little impact as possible. We have not seen any noticeable loss of our market share in the U.S. as a result of this, but there has been some PR push back if you say so, but this is to be anticipated.

Human insulins are available in the U.K. market from other vendors and what we do have to do is we actually refer the patients that are insisting on staying on human insulins, that they can procure other variants of insulin as opposed to the Novo Nordisk product. That’s a sad reality if everyone stayed on products that we withdraw, but no major impact.

Thank you. Next question please.

Operator

Our next question for today comes from Jacob Thrane from Standard and Poor’s. Please go ahead.

Jacob Thrane – Standard and Poor’s

Thank you gentlemen for taking my questions. Just a question on the R&D expenditure. It seems like looking at the cost margin level is sort of going a little down. I’m just wondering if the amount level, like the 2302 you just reported for this quarter, is it sort of the level we’re going to expect going forward or are you still sort of looking to a I believe it’s been mentioned in the Q1 presentation, it was around 16% cost margin, even a little higher. That’s my first question.

And just on the weight loss, we’re seeing with Liraglutide, I’m just wondering the sort of approximately six kilograms referred to as the weight loss is sort of blurred I think. Can you shed a little light on what the confidence in those are around these six kilograms because I assume that’s against the approximate 100 kilogram average we saw before they started. That brings it up above the 5% sort of metric border in this area. If you could help me with that. Thank you.

Lars Rebein Sorenson

Thank you very much. We’ll go to the first question, the R&D expense. I’m going to give this question to Jesper, because otherwise Mads will tell you that the expenses are going up significantly because he really wishes that they would do that. So to get an unbiased, qualified answer, we should probably get Jesper on that one, and then Mads can come back on the weight loss.

Jesper Brandgaard

It is correct. When you look at the quarter alone, we are only reaching in reported numbers a level of around 15%. That’s of course below the 16% that we were hoping for. We have been kind of impacting by having a high proportion of our overall R&D costs located in Danish Kroner, and the ramp up of the Liraglutide trials is happening in the third quarter and of course going into full phase trials as we get into the fourth quarter, so you should anticipate that our overall ratio will increase as we get into full year, but the currency impact is bringing it a little bit down. In the third quarter alone, you had a positive 80 basis point impact on the ratio from common currencies.

Lars Rebein Sorenson

OK. Thank you Jesper and then Mads, weight loss.

Mads Krogsgaard Thomsen

Yes, well indeed interesting question. If you look at it by section out between the weight loss curve from Lira treatment compared to the blind placebo treatment, you see already that after two weeks the standard errors of the means are by no means overacting and I’d understand the deviation. So the dissection happens out already within the first fortnight of the onset of therapy and increases up to and including the first half year, where after we have more parallels between the two lines suggesting that the difference between the curves is maintained over time.

Not surprisingly, upon cessation of therapy after 56 weeks, we of course to see some weight increase as expected.

Lars Rebein Sorenson

So ladies and gentlemen, unfortunately the hour has passed 2:00 in Denmark and our investor team has to go forward and have a presentation in Copenhagen. So we apologize, we have to close this exciting meeting. We thank you for listening in and we are looking forward to come back to next year on the second of February with the full year results and with the guidance for 2011. Thank you.

Copyright policy: All transcripts on this site are the copyright of Seeking Alpha. However, we view them as an important resource for bloggers and journalists, and are excited to contribute to the democratization of financial information on the Internet. (Until now investors have had to pay thousands of dollars in subscription fees for transcripts.) So our reproduction policy is as follows: You may quote up to 400 words of any transcript on the condition that you attribute the transcript to Seeking Alpha and either link to the original transcript or to www.SeekingAlpha.com. All other use is prohibited.

THE INFORMATION CONTAINED HERE IS A TEXTUAL REPRESENTATION OF THE APPLICABLE COMPANY’S CONFERENCE CALL, CONFERENCE PRESENTATION OR OTHER AUDIO PRESENTATION, AND WHILE EFFORTS ARE MADE TO PROVIDE AN ACCURATE TRANSCRIPTION, THERE MAY BE MATERIAL ERRORS, OMISSIONS, OR INACCURACIES IN THE REPORTING OF THE SUBSTANCE OF THE AUDIO PRESENTATIONS. IN NO WAY DOES SEEKING ALPHA ASSUME ANY RESPONSIBILITY FOR ANY INVESTMENT OR OTHER DECISIONS MADE BASED UPON THE INFORMATION PROVIDED ON THIS WEB SITE OR IN ANY TRANSCRIPT. USERS ARE ADVISED TO REVIEW THE APPLICABLE COMPANY’S AUDIO PRESENTATION ITSELF AND THE APPLICABLE COMPANY’S SEC FILINGS BEFORE MAKING ANY INVESTMENT OR OTHER DECISIONS.

If you have any additional questions about our online transcripts, please contact us at: transcripts@seekingalpha.com. Thank you!

Copyright policy: All transcripts on this site are the copyright of Seeking Alpha. However, we view them as an important resource for bloggers and journalists, and are excited to contribute to the democratization of financial information on the Internet. (Until now investors have had to pay thousands of dollars in subscription fees for transcripts.) So our reproduction policy is as follows: You may quote up to 400 words of any transcript on the condition that you attribute the transcript to Seeking Alpha and either link to the original transcript or to www.SeekingAlpha.com. All other use is prohibited.

THE INFORMATION CONTAINED HERE IS A TEXTUAL REPRESENTATION OF THE APPLICABLE COMPANY'S CONFERENCE CALL, CONFERENCE PRESENTATION OR OTHER AUDIO PRESENTATION, AND WHILE EFFORTS ARE MADE TO PROVIDE AN ACCURATE TRANSCRIPTION, THERE MAY BE MATERIAL ERRORS, OMISSIONS, OR INACCURACIES IN THE REPORTING OF THE SUBSTANCE OF THE AUDIO PRESENTATIONS. IN NO WAY DOES SEEKING ALPHA ASSUME ANY RESPONSIBILITY FOR ANY INVESTMENT OR OTHER DECISIONS MADE BASED UPON THE INFORMATION PROVIDED ON THIS WEB SITE OR IN ANY TRANSCRIPT. USERS ARE ADVISED TO REVIEW THE APPLICABLE COMPANY'S AUDIO PRESENTATION ITSELF AND THE APPLICABLE COMPANY'S SEC FILINGS BEFORE MAKING ANY INVESTMENT OR OTHER DECISIONS.

If you have any additional questions about our online transcripts, please contact us at: transcripts@seekingalpha.com. Thank you!

Source: Novo Nordisk CEO Discusses Q3 2010 Results – Earnings Call Transcript
This Transcript
All Transcripts