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Novo Nordisk A/S (NVO)

Q4 2012 Earnings Call· Thu, Jan 31, 2013

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Transcript

Operator

Operator

Thank you very much and welcome to Novo Nordisk Conference Call regarding our performance in 2012 and the outlook for 2013. I am Lars Rebien Sørensen, the CEO. With me I have our Chief Financial Officer, Jesper Brandgaard; Mads Krogsgaard Thomsen, our Chief Science Officer; and present are also our Investor Relations officers. Today’s earnings release and the slides for this call are made available on our webpage on novonordisk.com. As you heard, the conference call is scheduled to last approximately one hour and as usual we will start with a presentation as outlined on Slide 2. The Q&A session will begin in about 30 minutes. Turn to Slide 3. As always, I need to advise you that this call will contain forward-looking statements. Such forward-looking statements are subject to risks and uncertainties that could cause the actual results to differ materially from expectations. For further information on the risk factors, please see the earnings release and the slides prepared for this presentation. Also note that this conference call is being webcast live and a replay will be made available on our website after the call. Turn to Slide 4. 2012 has been another good year for Novo Nordisk. Sales increased 18% as we reported and 12% in local currencies. Sales growth was driven by strong performance in North America and International Operations and China. Key sales drivers have been our Modern insulins and Victoza, among the Modern insulins in particular NovoRapid and Levemir drove the growth. On the R&D front, I note that regulatory reviews of Tresiba and Ryzodeg is showing good progress in the major markets. With the approval of Ryzodeg in December 2012, both products are now approved in Japan. For Tresiba, price negotiations with the Japanese authorities are continuing. They are still expected to be concluded…

Mads Krogsgaard Thomsen

Management

Thank you, Lars. Please turn to the next slide. The regulatory made the use of Tresiba and Ryzodeg continue to progress. With the recent filings in nine additional countries and most recently submission of Tresiba regulatory review in Argentina. As previously announced, the European Commission granted marketing authorizations for Tresiba and Ryzodeg for the treatment of diabetes in adults in January 2013 and the label text for both products is now available online at the EU Commission’s website. As previously mentioned, label will also apply to large number of countries outside Europe and the label text acknowledges superiority of Ryzodeg on a number of parameters including overall in nocturnal hypoglycemia and fasting plasma glucose control, as well as increasing dosing capability. Novo Nordisk expects to launch Tresiba in the UK and Denmark during the first half of this year and in other European markets throughout the rest of 2013 and 2014. Ryzodeg has now also been approved from Japan but price negotiations for Tresiba are also expected to complete this quarter immediately to be followed by launch. In the US, the FDA advisory committee voted 8 to 4 in favor of approving the (inaudible) with a post-approval commitment to perform cardiovascular outcomes trials. Following the ASCO meeting, the FDA regulatory process has continued to progress, albeit we have not been informed about the deadline for completion of the remainder of the process. Please turn to the next slide. As announced last December, DUAL II, the last HbA trial for IDegLira, the once-daily fixed ratio combination of between (inaudible) has been complete. The trial with double bind is 1 to 1 randomized Type-2 trial conducted in 400 mostly long standing Type-2 diabetes patients, previously treated with oral anti-diabetes and basal insulin. Intriguingly at from HbA1c baseline in the high 8%, I…

Jesper Brandgaard

Chief Financial Officer

Thank you, Mads. Please turn to Slide 16. In 2012, sales increased by 18% measured in Danish kroner to 78 million and by 12% in local currencies. The reported gross margin improved by 170 basis points to 82.7% in 2012. The improvement was driven by favorable price development in North America and positive impact of the product mix due to increased sales of both Modern insulins and Victoza. The improvement in the gross margin includes a positive impact from currencies of 70 basis points. The non-production related costs increased by 12% in Danish kroner to 35.8 billion and by 8% in local currencies. F&D costs increased by 13% to 21.5 billion and by 8% in local currencies. The growth in local currencies is primarily driven by the expansion of the U.S. sales force and other costs to prepare for the global launch of Tresiba. Furthermore, costs increased due to sales and marketing investments in selected countries in IO as well as the Chinese sales force expansion that was placed mid-2011. Growth in sales and distribution costs is partly offset by a reversal of provisions for legal disputes. R&D costs increased by 13% to 10.9 billion and by 11% in local currencies mainly driven by development costs related to the ongoing phase 3 trials for liraglutide in obesity and the phase 3a trials for IDegLira. Within biopharmaceuticals, R&D costs are primarily related to the continued progress of the portfolio of development projects within hemophilia and the phase 2 trials for anti-IL-20 in rheumatoid arthritis. Operating profit increased by 32% in 2012 to 29.5 billion. In local currencies the growth was 20%. Mid-financial showed an expense of 1.7 billion in 2012 compared to an expense of around 450 million in 2011. In line with Novo Nordisk Treasury Policy, the most significant foreign…

Lars Rebien Sorensen

Management

Yes, thank you very much Jesper and Mads. So to summarize 2012 was a good year for Novo Nordisk. We delivered a strong financial results, we managed to strengthen our position in the diabetes care market where we today own the market share 26% of the value, further more we’ve seen significant progress in our clinical development pipeline. We believe this promising pipeline puts Novo Nordisk in a unique position of strength for the future. We are now moving into Q&A part, where I kindly ask all participants to restrain themselves to two questions. Operator you may now, we are ready to take first question please.

Operator

Operator

(Operator Instructions) We will take our first question from Peter Hugreffe of ABG, please go ahead. Peter Hugreffe – ABG: Yes hi, Peter Hugreffe, ABG. Thank you very much for taking my questions. First of all in terms of the inspection you are mentioning from the FDA and the subsequent warning, could you elaborate in terms of it has had any impact on the Tresiba approval process. And also is there any breakthrough to the talks with the MA? Then secondly in terms of the Tresiba approval process with the FDA, could you elaborate a little bit in terms of the dialogue you are having and maybe to come with some comparisons with the dialogue you had on Victoza. Thank you.

Lars Rebien Sorensen

Management

Thank you very much, this is Lars Rebien here and I will deal with the issue of the inspections, and Mads if you would care to comment on the quality of the dialogue with the agency in United States, compared to Europe. In regards to the warning letter, it has had no impact, it was a US inspection so it has no impact on the situation, vis a vis Europe. It was a routine [ph]CPLP inspection which took place in several locations of our manufacturing sites to which some observations was made, so its normally as we do and Novo Nordisk has responded. Apparently, the response from one of the septic filling plants here in Denmark has not been sufficient to satisfy the agency and, hence, in December of 2012 we receive a warning letter covering two specific observations and some points under these two specific observations. And it is a little bit unusual that we announced that we received the warning letter in this March, as the FDA has not posted the warning letter on their website, which they usually do. And therefore we would like to restrict our comments into the technicalities of this warning letter, as we are in the process of ensuring that our response, which was submitted towards the end of December is complete and satisfactory to the FDA and until we’ve had such dialogue, we intend not to comment on it, has had no impact on our market and probably we don’t anticipate that it will happen. It has not been linked to Tresiba either, but we have to be of course cautious in the sense, that FDA has certain sanctions towards companies expanding all the way from closing warning letters to re-inspections, to operating plants under the Consent Decree to postponing approval of new applications. However, these are the measures the FDA has and further we speculate in any of those yet, until we’ve had a dialogue on our recently submitted response. Mads?

Mads Krogsgaard Thomsen

Management

Right, so if I got you right Peter, the question relates to a comparison of the nature of the dialogue with the FDA post AdCom in the case of Victoza versus Tresiba. That’s a little bit of broad question, what I can say though is that if you go back to those days in 2009, where we had the AdCom on Victoza, there’s no doubt that it was pretty much about risk, i.e. there was really no true clinical discussion about the benefits in terms of the clinical use of Victoza and quite frankly lot of the discussions after the Victoza AdCom, also had to do with the overall clinical review, which at that point clearly had only been partly underway. Hence there was not only a focus on all the topics of that particular AdCom including C cell safety and so on, there was also a lot of very detailed clinical discussions right up until the very happy end on January 25, 2010 when we got the approval. I would say it’s a fair statement that for Tresiba there has been more discussion of benefit and risk, i.e. it is, what is true benefit/risk evaluation that took place at the AdCom on (inaudible). And obviously some of those comments that were, or issues that were discussed, hypoglycemia benefits, potential for cardiovascular risk profile, etc, etc. They have obviously as you can imagine popped up as discussion items and things where we have had queries from the agency even since the AdCom as a natural part of that process. Obviously, also Novo Nordisk had adapted to the discussions in depth of course, we are at the point where it’s natural that the company does submit its various suggestions including package insert language and so on, but obviously at this point, we are not at the point of discussing the specifics of the label and I think that is as far as I would go at this point, it is a confronted dialogue in this progress. Peter Hugreffe – ABG: Thank you very much Mads.

Lars Rebien Sorensen

Management

Next question.

Operator

Operator

And we will take our next question from Sachin Jane of Merrill Lynch, please go ahead. Sachin Jane – Merrill Lynch: Hi, thank you for taking my questions. Just two. Firstly, on the fast acting insulin analogue, could you clarify what's taking the time before you start the phase III only at the end of this year? Just what's the delay for that? And then, related, is there any plan for a pre-mix with Tresiba? I'm not sure if you're commented on that. So that's the first question. The second question is just a very broad question around the Victoza obesity program. As we approach the phase III data, I wonder if you could just clarify the positioning you intend for this product. It's something you've refrained from discussing today, but I wonder if you could just discuss broadly the BMI populations, the extent of diabetes overlap and potentially how you plan to use the sleep apnea study that's coming out midyear. Thank you. Lars Rebien Sørensen: Thank you very much Lars Rebien here. I would like Mads Krogsgaard’s comment on your first question and then I’ll come back on obesity and what I am thinking is in terms of positioning on that. Okay, so Sachin, first of all, the PS Project, just for you to understand, has been a whole range of clinical activities where we ended up in the final round between 200 candidates where once we select a lot of these and that has been taking place very recently. We need to make sure since we're leapfrogging over phase II and directly into phase III that we also have sufficient amount of stability data for the Company to conduct a full-blown phase III program. This is a new product, it is a new brand. This is not,…

Mads Krogsgaard Thomsen

Management

Only just to corroborate that the trial population, even though we've abided with FDA’s demand for just treating anybody above 30 or anybody above 27 with a co-morbidity, the fact of the matter is that the patient Lars is describing is the average one in the trial. So, the BMI average will be above 35 and the amount of people with pre-diabetes will at least be 50% at baseline. So, we are actually, funnily or interestingly enough discussing more or less the population that Lars is describing also as the target on average. Sachin Jane – Merrill Lynch: Just one follow on, if I may. The uniqueness of the sleep apnea study in this population and what discussions you've had around that, the results for that study potentially with payers, any color there? Lars Rebien Sørensen: Yes, Sleep apnea is a very specific related, the physical kind of sleep apnea we are talking about is related to severe obesity, and the way we are doing that it’s going with some very focused specialist centers where we are measuring all the hallmarks of sleep apnea and seeking to improve those in a study, in limited population, but with sophisticated metrics. And that one would actually report slightly later than the others, but it will still be kind of during the summertime. And you will see, part of the health economic package that we will be bidding later on.

Jesper Brandgaard

Chief Financial Officer

Thank you. Next question, please.

Operator

Operator

And we will take our next question from Richard Vosser of J.P. Morgan. Please go ahead.

Richard Vosser - J.P. Morgan

Analyst · J.P. Morgan. Please go ahead

Hi, Richard Vosser from J.P. Morgan. Thanks for taking my questions. First question, just on the gross margin and COGS, the fourth quarter had a substantial improvement in the gross margin. It was much more than the other quarters. Just wondering if you could give us some details of the improvements there, anything specific to that quarter that saw the very low COGS or very high gross margin? And then, as we go into 2013, with currency headwinds, I suppose potential remediation costs around FDA inspections, could you get us some help on how that could develop? And then, secondly, just on Tresiba, we have seen the label in Europe, you have now got the label and it looks to have all the nocturnal hypoglycemia, etcetera as you have mentioned on that. Just wondering your pricing, your strategy in Europe, how that’s panning out and what you think that’s going to be? Thanks very much. Lars Rebien Sørensen: Thank you very much. Jesper, why don’t you take the margin, both for the fourth quarter and then also how you look at it going forward into ’13?

Jesper Brandgaard

Chief Financial Officer

It’s correct, Richard, we had an unusual strong fourth quarter. We always lived the quarters in looking at our production costs with the capitalization moves etcetera that is for the amount produced, but everything else was equal. It was a strong quarter with a high capacity utilization in our diabetes care units. And I would not expect that we would have the same degree of capacity utilization fully into 2013, partly also related to the uncertainty surrounding the full scale-off of the Tresiba production facility that we have made ready. So, I think the average for the year is a data guiding point for where we got to end. So, I think if you take it the starting point for the year around gross margin of just below 83%, and then I hope we would be able to improve on that in the 50 to 100 basis points like we have done in previous years. We are facing a negative currency impact on the gross margin in the ballpark of around 20%. You did ask for specific cost in relation to remediation costs in this warning letter, and I would say that we are not expecting any very significant cost. It is not expected to involve significant restructuring or rebuilding of these facilities. Lars Rebien Sørensen: Thank you very much. Then, maybe I should answer the question on the situation in Europe and pricing of Tresiba going forward, and clearly, the biggest potential that we have for Tresiba, it could be in the United States, and it’s also where we are having liberal pricing environment. Obviously, we need to justify the price, the different healthcare organization and the insurance companies, but we will get to that as we move along. When we talk about Europe, we have stated all along that we need to see a premium on Tresiba in Europe because the European price level is, to some extent linked to our export private markets, and because many of the export private markets in American markets are returning back to home country, both for approval but also for reimbursements status and price. And so, the balance for us is that we probably need to take a higher premium in Europe, which to some extent can slow down the penetration and the rollout in Europe, out of consideration to get a decent price in overseas markets. This is probably the best and mixed – yes, but did you have any further --?

Jesper Brandgaard

Chief Financial Officer

I actually made a misstatement of the currency impact, it (inaudible) of course, it was a 20 basis point negative impact and not a 20 percentage points, I apologize for that. Lars Rebien Sørensen: Wow, that was straight back. Okay, I think –

Richard Vosser - J.P. Morgan

Analyst · J.P. Morgan. Please go ahead

Thank you. Lars Rebien Sørensen: Thank you very much for the questions. Thanks for the clarification. Next question please?

Operator

Operator

And we will take our next question from Martin Parkhoi of Danske Bank. Please go ahead.

Martin Parkhoi - Danske Bank

Analyst · Danske Bank. Please go ahead

Hello, Martin Parkhoi from Danske Bank. First a question on the long-term targets to Jesper. Now you're guiding – I guess your long-term target is on a three to five year horizon. So if you assume that you're hitting a margin of 40% in four years, and keeping up with 15% annual EBIT growth, you actually need to make a top line growth of more than 13% a year. Should we actually – should we assume that your top line growth actually will accelerate from the 12% level we saw underlying in 2012? And then the second question goes to liraglutide in Type 1 diabetes. Could you reveal the timeline and then also could you give some elaboration on the commercial opportunities you see there? Lars Rebien Sørensen: Thank you very much, Martin. Well, that’s some of the model issues there for you, Jesper, you want to dig into. And we got to the long-term financial guidance, top line and EBIT growth.

Jesper Brandgaard

Chief Financial Officer

Of course, Martin, if the world was so perfect that you were able to model your financial performance so that in fact we keep the target at the same point every time we put in forth, it would be easier to be an analyst invariably. I think we have historically always moved with the targets in rounded numbers. I think it’s largely that we will see an increase in our turnover level if we are successful with getting the approval of Tresiba and having that mentioned behind our franchise. And as we have also alluded to before, Lars and I, when we had Tresiba on the market, it improves our situation in terms of actually starting gaining market share within diabetes care treatment. It enables us to launch into the biggest single incoming market in the world, the long-acting segment in the U.S., and hence that should actually provide for everything else being an equal and acceleration of our top five, but let’s see how the approval process goes, let’s see how the label turns out, but the equation level is clearly within the long-term target of a continuation of a double-digit, both in the top line and linked to that then an expansion in the market. Where they will hit each other is the exact, we will have to see. Lars Rebien Sørensen: This is Lars Rebien here, just an addition to this, we have anticipate that there will be some kind of rebalancing of the public projects in the United States, not this year, maybe not even next year, but in the three-to-five year time horizon, it is not unlikely that some initiatives will be taken, which may also impact the healthcare sector. And as we know it, typically pharmaceuticals are being impacted as a result of that. So, that is why we are being somewhat cautious about giving you too bullish a top line number, inspire the fact that we do believe that we are in the best competitive position that we have ever been with the launch of both Tresiba and Ryzodeg. That is the trial of using Victoza in Type 1 diabetes. What are the timelines and any commercial potential in this as you see it?

Jesper Brandgaard

Chief Financial Officer

Yes, well, first of all, there’s no doubt Martin that when you look at the commercial potential on everybody who has Type 1 diabetes worldwide is today under, you can say typically multiple daily injections with insulin. And what the potential is here is a new paradigm where you use, if you want to analog in this case, the liraglutide as an add on. The rationale for that which we confront in the clinical study, that is just completed. In fact, you buy reducing the excess glucagon that is also present in Type 1 diabetes subjects, you will first of all reduce the need for insulin, you will also have the present effect that makes you lose a bit of weight and become more insulin sensitive, which further improves the problem. And what we have seen both in anecdotes and investigate an initiative is that it seems as if the time spent in the near-normal glycemic zone is enhanced. So, for the patient, there’s a lot of value in actually getting into better control or reducing the amount of glycemic effects at the same prevailing HB1C level, while also harvesting benefits on body weight and insulin sensitivity and insulin dose. So, that’s what we are going to set out to study in two major trials, one bigger than the other because it’s a superiority trial, and they have negotiated with the FDA and EMA very recently, and the first one will start in the second half of this year, that’s the one-year trial and the other one which is a six-month trial, we will start as soon they offer, such that both are destined to complete with an estimated approval. If we are lucky at the end of ’16, but as soon as we can. So, we are really meeting the series. There are millions of people with Type 1 diabetes out there and we will have to look at the profile emerging from Phase 3, before I can be more specific about the sales, but of course, it’s high. Lars Rebien Sørensen: Thank you very much. And next question, please.

Operator

Operator

We will take our next question from Michael Novod of Nordea. Please go ahead.

Michael Novod - Nordea

Analyst · Nordea. Please go ahead

Yes, hello, it’s Michael Novod from Nordea Markets in Copenhagen. Just a follow on to the obesity questions. I guess we will also start to discuss whether you will be required or not to do pre-marketing CV trials for Victoza in obesity. Can you put some more flavor to that? Are there any progress in discussions with the FDA? Have you had more discussions around this? What should we expect now when we see the data that we bought out very soon? And then the second question, maybe you could try to put some flavor on the difference to the guidance rate on the top line between 8% and 11%. Is that where the Victoza growth 150 million per quarter or 200 million per quarter, is it the (inaudible) Can you try to give some more flavor on the actual split? Lars Rebien Sørensen: Thank you very much, Michael. Next, where are we in regards to CV, free of cast approval on using my (inaudible) and where’s the FDA on that in your assessment to write-down. They comment on the range for the telephone guidance. Well, it’s our assessment in having discussed with the regulators that obviously initial things to do, to combine and do an analysis of what exists or pre-existing trials that what CV has been measured, including the lead program, the scale program, the B trials for Victoza in diabetes. And this would be admittance from regulators and ourselves that the dose are not the same i.e., 1.8 versus to be, but it’s always the bodyweight of the same and hence the exposure typically is only 30%, make 40% difference between the two populations. And there is an understanding that the overarching pathophysiological elements underlying large vessel disease are somewhat similar, whether you are 45-year-old obese woman…

Operator

Operator

And we will take our final question from Brian Bourdot of Barclays. Please go ahead.

Brian Bourdot - Barclays

Analyst · Barclays. Please go ahead

Thank you very much. It's Brian Bourdot at Barclays calling from London. Two things I would like to ask about please. Firstly LAI287, and secondly Tresiba. Firstly, I would just like to ask you how LAI287 is engineered please? Is it acylated? Presumably, it's not pegylated and doesn’t have the potential, you think to possibly serve the needs of all patients requiring basal insulin therapy? And that's my questions on LAI. Secondly on Tresiba, just wondering how confident you are that approval will come in 2013. And I ask that question from the point of view of the significant review time the FDA has taken over some diabetes medicines in recent history, and I guess one of these is thinking about Victoza, you've already talked about that. But another one that I think of is Alogliptin where the FDA has approved it with a commitment for post-approval cardiovascular selective studies, albeit after a very lengthy delay. So, any thoughts on that please. Thank you very much. Lars Rebien Sørensen: Yes, LAI287. Yes, so Brian, very briefly, LAI287 does actually represent. You can see a case where we have had to look into our own publications and the text books about why is it that even the longest acting insulins tend to have a very brief-circulation half-life. The longest one I knew about is Tresiba over the circulation half-life of four hours and from that it’s about 20 minutes. So, it’s embedded because the currency mechanism of the body, which is insulin receptor mediated uptake, i.e., into cytosis followed by degradation. So, what we have done is met that process and then we have looked at how can we manipulate that system. And the way to do that chemically is by both introducing the modification at the level of the human…

Jesper Brandgaard

Chief Financial Officer

It is usually so that the FDA follows, so that they can measure from – so we kind of surprising, let’s put it that away, if we were to receive a complete response. Lars Rebien Sørensen: Ladies and gentlemen, so we are anticipating that we are going to launch Tresiba all over the world during the first half of this year, and we thank you very much for your attention, and we will stay tuned, and I am sure we will be having much more conversations during the next couple of days on this, and of course, also as we progress and roll out, I am sure we will still have your continued interest. Thank you very much.