Novo Nordisk A/S (NYSE:NVO)
Q4 2012 Earnings Conference Call
January 31, 2013 08:30 AM ET
Lars Rebien Sørensen - President and Chief Executive Officer
Mads Krogsgaard Thomsen - Executive Vice President and Chief Science Officer
Jesper Brandgaard - Executive Vice President and Chief Financial Officer
Peter Hugreffe – ABG
Sachin Jane – Merrill Lynch
Richard Vosser - J.P. Morgan
Martin Parkhoi - Danske Bank
Michael Novod - Nordea
Brian Bourdot – Barclays
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 during this first quarter of this year.
In Europe, the European Commission granted marketing authorization for Tresiba and Ryzodeg on January 21st this year. Authorization covers all 27 European member states and we expect to launch Tresiba in the (inaudible) during this first quarter of 2013.
In the United States, the FDA advisory committee meeting for Tresiba and Ryzodeg was held on October 8 last year. At the meeting, the advisory committee voted 8 to 4 in favor of approving the product with the recommendation for cardiovascular outcomes trial post approval. The dialog with the agency continues to progress, but the agency has not informed us of when it expects to conclude its ongoing review of the NDAs.
Turning to the financials. Reported operating profit grew 32% and diluted earnings per share grew 30%. For 2013, we expect sales growth of 8% to 11% and we expect operating profit growth to be around 10%, both measured in local currencies. The solid performance has made us to revisit our long-term financial targets. Every customer we sell operates in two of these. Jesper will provide more insight into the revised targets later during this call.
Turn to Slide 5. We continue to track our social and environmental performance. In terms of social performance, the number of people estimated to use Novo Nordisk diabetes care products has increased from 21 million to 23 million in 2012. The increasing number of people globally rely on the Novo Nordisk treatment is also reflected in the growing organization. Novo Nordisk now employees more than 34,000 people. Assurance including (inaudible) and reinspection is also followed as part of our social performance. (inaudible) current good manufacturing practice inspection by the FDA at a filling plant in Denmark in the spring of 2012, Novo Nordisk received a warning letter citing two specific observations in December 12. Novo Nordisk takes these observations very seriously and (inaudible) our response letter which was submitted later in December committed to taking the appropriate steps to address the concern (inaudible) by the FDA. We do not expect the (inaudible) to have impact on our currently marketed products. With regards to environmental performance, we have in 2012 seen increases in CO2 emissions as well as an energy and water consumption. This development is driven by higher production volumes and phase-in of our new filling plant in Tianjin in China.
Turn to Slide 6. Effective 31st of January, 2013, Novo Nordisk’s executive management has been expanded with two new members, Jakob Riis is appointed as Executive Vice President with responsibility for Marketing and Medical Affairs and Lars Fruergaard Jørgensen is appointed as Executive Vice President with the responsibility for IT, Quality and Corporate Development. This change lists the direct responsibility of these critical functions into executive management while also broadened the group of senior managers. The biographies for the newly appointment Executive Vice Presidents can be found on novonordisk.com. Effective 1st of March, four corporate Vice Presidents in the Novo Nordisk US has been appointed Senior Vice Presidents and member of company’s close senior management board. The promotions reflect the increasing size, complexity and strategic importance of Novo Nordisk’s business and development pipeline in the US.
Turn to Slide 7 for a regional sales update. In 2012, North America accounted for 66% of growth followed by international operations accounted for 20% of growth, both measured in local currencies. Sales for North America was 19% in local currencies reflecting a continued robust market penetration of the Modern insulins in particular NovoLog and Levemir. Victoza also continued to perform well despite the launch of the competing product. Sales growth in Europe in 2012 were 2% measured in local currencies. Sales (inaudible) reflects continued solid performance of Victoza and progress for the portfolio in Modern insulins, but especially Levemir is doing well. Sales growth remains negatively impacted by declining sales of human insulin, a low insulin volume growth, as well as healthcare (inaudible). Sales in international operations grew 16% in local currencies driven by the (inaudible) Modern insulin, a robust human insulin sales growth and continued expansion of the (inaudible) market. Sales in Japan and Korea declined 2% in local currencies. Compared to 2011, the sales in Japan and Korea reflects a negative impact for low insulin volume growth and the challenging competitive environment. The negative development in insulin is only partly covered by an increase Victoza, NovoSeven and Norditropin sales. Sales in the region China increased 16% in local currencies, the growth was driven by Modern insulins, especially NovoLog Mix continues to perform well. Sales of NovoNorm, our tablet-based treatment of Type-2 diabetes also contributed significantly to growth in China.
Turn to Slide 8. The Modern insulins continued to exhibit strong growth in ’12 amounting to 15%, while Victoza also continues to steadily grow. 2012, the diabetes care franchise grew 15% while biopharmaceuticals franchise grew 2%, measured in local currencies. Modern insulins were the primary growth driver amounting to 55% of growth followed by Victoza accounted for 39% of growth, all in local currencies. Sales of NovoSeven increased 2% when measured in local currencies. The growth in NovoSeven was driven by strong sales in Japan and North America. Sales of NovoSeven were in general negatively impacted by strict budgetary controls and increase in inhibitor patients participating in clinical trials. Sales of Norditropin increased 8% in local currencies. The sales growth was mainly driven by North America and international operations. Novo Nordisk is the now the largest company in the growth hormone market with a volume market share of 24%.
Turn to the next slide, please. In the last 10 years, the global diabetes care market has grown close to 10% in value annually with injectables growing more than 15% annually. In this period, Novo Nordisk expanded its leadership position within diabetes care and currently the company holds 26% value market share of the global diabetes care market, up from 24% at the end of 2011.
Turn to Slide 10. In the last five years, the global insulin market has grown to more than 15% in value on an annual basis. The growth in value has been driven by volume growth and a gradual shift from human insulin to Modern insulin as part of increased penetration of devices. In the growing insulin market, Novo Nordisk has been able to sustain a strong position and today the company holds 46% of the Modern insulin market measured by volume.
Turn to Slide 11 for an update on Victoza. Sales of Victoza reached 9.5 billion Danish kroner in 2012. This reflects solid performance driven by North America, Europe, as well as continued penetration in key markets across international operations. Victoza has exhibited a steady sales growth trend with the average of quarterly increases of approximately 200 million Danish kroner. Going into ’13, we expect the quarterly increases to be slightly lower as a result of further competitive pressures. In the US, Victoza sales continues to be largely unaffected by the launch of competitors products. Victoza is gradually increasing its market share and now account for approximately 62% of GLP-1 market by value in the United States. In Europe, we continue to see strong uptick of Victoza across all key markets and Victoza remains the leading GLP-1 product with a market share of 76%.
With this Mads will update on research and development.
Mads Krogsgaard Thomsen
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 think (inaudible) reduced HbA1c with almost 2 percentage points. Hence bringing most patients to talk at through convincing control of both fasting and post pain due glucose levels. In spite of this, both hypoglycemia and nausea rate was very low and treatment was further more accompanied by an average weight loss of 5 pounds. Together with the results from Q1, Q2 confirms the highly competitive profiles of Tresiba and Victoza in combination, regardless of when in the Type-2 diabetes treatment has gained, the product will be used in the future. Novo Nordisk has planned for regulatory filing of IDegLira in the EU mid-2013 and in the United States as soon as possible during the year pending marketing authorization of Tresiba.
Please turn to the next slide. As announced in December, a series of phase 1 proof of principle trails for a number of different faster-acting formulations of insulin aspart, called FIAsp, have now been completed. FIAsp is a novel insulin aspart product that has been designed to allow for insulin absorption already within the first few minutes of the injection through the tailored use of formulation recipients that’s been selected on the basis that they all occur naturally in the human body. The formulation selected for phase 3a development more closely (inaudible) to help insulin secretary response to (inaudible) than does NovoRapid as shown on the slide. This enables improved post payment of glucose control as well as more flexible timing of each administration in connection with the meal. Importantly, FIAsp will piggyback on the excellent safety of todays’ most used insulin product, NovoRapid. Novo Nordisk expense to initiate the phase 3a program called onset towards the end of the year. Onset is expected to include around 3000 people with Types-1, or Type-2 diabetes and both multiple daily injections and pumping fusing regiments will be investigated in the onset program.
Please turn to the next slide. Novo Nordisk has completed a four-week clinical pharmacology trial investigating the use of liragluide as an adjunct to insulin therapy for people with Type-1 diabetes. The trial shows that the liraglutide treatment neither compromises the glucagon response during hypoglycemia, no other competitor regulatory responses. Furthermore, liraglutide interim requirements and body wait decreased in the dose dependent men. Also, the continuous glucose monitoring data suggest that patients may increase the time spend in the glucose target store following combined Victoza and instance treatment in Type-1 diabetes. Finally and importantly, the clinical data from this trial appears to confirm the overall safety profile of liraglutide.
In the second half of this year, Novo Nordisk expects to initiate the phase 3a program should adjunct and including around 2,000 people with Type-1 diabetes.
Finally, within diabetes Novo Nordisk has initiated the first phase 1 trial with LAI287, a novel insulin analogue that potentially opens up a paradigm with once-week insulin administration. The molecule thus represents the very latest within the evolution of rational (inaudible) and side change design at (inaudible). The trial investigates the safely or ability of pharmacokinetic and dynamics of LAI287 in approximately 80 healthy volunteers and Type-1 diabetes subjects.
Within our Biopharma pipeline, NovoThirteen known as (inaudible) in Canada has not been launched in Canada and Denmark. In the US, Novo Nordisk has now resubmitted the biologics license certification. Turoctocog alfa, a recombinant coagulation factor VIII indented for prevention and treatment of bleeding in people with hemophilia A, has now also been submitted for approval in Japan, Australia and Switzerland. Within hemophilia, we have completed recruitment for the pivotal phase 3a trial for the wrong action in (inaudible) for which results are expected towards the middle of the year. For (inaudible) targeting hemophilia, we have found a pre-plant interim analysis of the baseline leading characteristics decided expand the ongoing pivotal phase 3a trial by approximately 40 patients. Consequently, the trial is now expected to be completed in the first half of 2014. For both of these projects and contingent upon positive product outcomes, it is expect that completion of pre-submission preparations including all products supply activities will result in around one-year time period between trial completion and regulatory submission in the first markets.
Finally, and as previously announced, Novo Nordisk has decided to discontinue further development of anti-NKG2D, that’s a treatment for Crohn’s disease.
With that, over to Jesper for an update on the financials.
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 exchanges approved has been hedged primarily through forward priority contracts. Affecting the portfolio are foreign currency exchange hedging contracts. The foreign exchange result was an expense of 1.5 billion compared to an expense of around 300 million in 2011. This development makes the losses on foreign exchange hedging involving especially the US dollar due to its appreciation versus Danish krone compared to the prevailing exchange rate levels in 2011.
The effective tax rate for 2012 was 22.9%. Please turn to the next slide. The two graphs illustrate the development of the US dollar and the Japanese Yen versus Danish krone. The tables on the right show the updated annual impact on operating profits of the 5% movement in each of our invoice and currencies and the current extent of hedging for the same currencies. During 2012, the average exchange rate for the US dollar versus the Danish krone was approximately 8% above the level in 2011. The Japanese Yen was approximately 9% above the level in 2011. At present, the value of the US dollar and the Japanese Yen is below the average seen in 2012.
Please turn to slide 18. The world expects sales growth in 2013 of 8 to 11% measured in local currencies. Even the current level of exchange versus the Danish krone, the reported sales growth is now expected to be around 4.5 percentage points lower than the growth measured in local currencies. The sales outlook measured in local currencies, reflecting a continued robust penetration of the modern insulins, a continued steady future performance and a positive sales contribution from Tresiba primarily in the US, EU and Japan.
The sales drivers will partly be countered by a challenging operating environment in major markets including price pressure, macroeconomic conditions in many international operations market and intensified competitive pressures. The outlook also include an assumption of generic competition in 2013 to our oral anti-diabetic product in the US.
For 2012, operating profit growth is expected to be around 10% measured in local currencies. This reflects significant cost related to the expected global launch of Tresiba, the expanded US sales force as well as sales and marketing investments in China and in a selected number of countries in international operations. Even the current level of exchange rate versus Danish krone the reported operating profit growth is now pegged to be around 7 percentage points lower than the growth measured in local currencies.
For 2013, Novo Nordisk expects a net financial income of around 1.5 billion reflecting gains associated with hedging contracts following the depreciation of the US dollar and the Japanese Yen versus the Danish krone compared to the exchange rates prevailing in 2011. The expectations to gain related to currency hedging contracts is however more than offset by the expected significant negative impact on before an operating profit from the depreciation of the same currencies versus the Danish krone.
The effected tax rate for 2013 is expected to be around 23%. So, given the improvement in their financials compared to 2012, the growth in net profit is at present expected to be double digit percentage point in 2013. Capital expenditures are reflected to be around 3.5 billion in 2013 primarily related to investments in filing capacity, a prefilled device production facility in Denmark and new place facility is also in Denmark. Depreciation, amortization and impairment losses I expect it to be around 3 billion and free cash flow is expected to be around 22 billion. All of the above expectations are based on the assumption that the global economic environment was not significantly change business condition for Novo Nordisk during 2013 and the currency exchange rate especially for the US dollar will remain at the current level versus the Danish krone.
Please turn to slide 19, at the annual general meeting on the 20th of March 2013, the board of directors will propose a 29% increase in dividends to 18 krone per share of one krone corresponding to the payout ratio of 45.3, for 2011 the payout ratio was also 45.3.
In addition the Board of Directors have approved a new up to 14 million share repurchase program to be executed during the coming 12 months. Novo Nordisk will initiate this program in accordance with the Safe Harbor Regulations. Skandinaviska Enskilda Banken in Denmark will act as a lead manager of the program and will in this capacity repurchase share on behalf of Novo Nordisk for an amount up to 3 billion Danish krone, during the trading period started today and ending on 29th of April, 2013.
Please turn to slide 20 for an update on our long term financial targets. Novo Nordisk introduced 4 long term financial targets in 1996 to balance short and long term considerations, thereby ensuring focus on shareholder value creation. The targets were subsequently revised and updated on several occasions and Novo Nordisk has now reached the performance level stipulated in the four long-term financial targets, and the target levels have for two of the targets consequently been revised.
The revised targets assumed a continuation of the current business environment. Significant changes to the business environment, including the structure of the US healthcare system, regulatory requirements, pricing environment competitive environment, healthcare reforms and exchange rates may significantly impact the time horizon for achieving the long-term targets or require them to be revised. The target level for operating profit growth remains at 15% on average. The target still allows for deviations in individual years if necessitated by business opportunities, market predictions or exchange rate movements. The target level for operating margin has increased from 35% to 40%, this is expected to be enabled by continued robust sales growth coupled with gross margin expansion for product mix and pricing as well as further productivity improvements in the manufacturing area.
For non-production related activities, the operating margin expansion is expected to be supported by a modest development in administrative costs and scale advantages within sales and marketing, whereas continued investment is envisioned for research and development activities, which are expected to grow in line with sales. The target level for operating profit after tax to net operating assets has increased from 90% to 125%. The base target reflects the expectation of a continued robust operating profit growth combined with a stable effective tax rate and relatively limited increase in debt operating assets. The target level for the cash to earnings ratio is maintained at 90% as expected continued growth in international operations and region China will gradually impact working capital requirements. As previously, this target will be pursued looking at the average over a three year period. This concludes the financial update, all back to you Lars for some closing remarks.
Lars Rebien Sorensen
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 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
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
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
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, as such, a follow-on compound. We are developing this as a new brand and, obviously you will need for this new product the stability data and normally, Sachin, it's not an issue, because you have phase II and there is ample time to do phase III stability studies. Here we actually as I mentioned leapfrogging into phase III which gives us not-so-much time to do stability. When we stay towards the end of 2013, I can tell you one thing we’ll do it as fast as we can and I’ll be more specific on page 3 starting later on in the year.
Whether PS can be used together with Tresiba is really a very good question and Novo Nordisk is never leaving any stone unturned when it comes neither engineering nor formulating various combinations of uploading. So, you can even discuss that at some data point.
Sachin Jane – Merrill Lynch
Thank you very much Mads and then on to obesity, we are approaching the final state where we will get the phase III data on obesity and we have actually for some time discussed and communicated our intended positioning which of course depends on the data, will be that we intend this product to be used for individuals with a BMI of 35 and above, but also with comorbidities such as elevated lipids, high myocardial infarction, high blood pressure etc. And so this is a population which is severely obese, who probably have had weight problems for several years, have participated in several programs to try to lose weight and when now the weight has become health risk to them, and something needs to be done unless they progress to diabetes or progress to an even more serious metabolic or cardiovascular situation. So, in these individuals we believe we can justify the use of potent pharmacological entities such as liraglutide. We think also, indeed, we can justify the relatively costly intervention because you got to remember that it is used in a higher doze and then what we typically use today in diabetes and hence you should also count on it being linearly priced, such that the application for obesity would be some 40% more expensive than the current daily consumption for people with pre-diabetes. It is the intention that longer term that we will follow up those individuals in the cohorts that had pre-diabetes, which can be recognized from their clinical parameters, whether or not their diabetes changes or whether we can postpone over longer periods of time their diabetes from progressing, or pre-diabetes from progressing into diabetes. So, those are the types of population we would like to position the drug against. And this is a significant opportunity if you look at it from a market perspective, because if we take, United States, we’re assuming that that population which I just described, its similar to the size of the current diabetes population in the U.S. And so needless to say, there is this big need and there is a big potential if we can show, that is effective sustainably effective, but also that the side effect profile is benign. Mads, do you have anything you would like to?
Mads Krogsgaard Thomsen
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.
Thank you. Next question, please.
And we will take our next question from Richard Vosser of J.P. Morgan. Please go ahead.
Richard Vosser - J.P. Morgan
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?
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 --?
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
Lars Rebien Sørensen
Thank you very much for the questions. Thanks for the clarification. Next question please?
And we will take our next question from Martin Parkhoi of Danske Bank. Please go ahead.
Martin Parkhoi - Danske Bank
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.
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?
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.
We will take our next question from Michael Novod of Nordea. Please go ahead.
Michael Novod - Nordea
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 or 16-year-old diabetic mail for that matter.]
So, that’s the initial approach. If somehow that creates unclarity and uncertainty, the next that has by no means being concluded could of course be to look into interim analysis offered for instance, the CV outcome trial for liraglutide, which would have been very well progressive at that point because eventually we are witnessing in that trial at least on power with what we have projected, when we initiated the trial, and that’s already commitment to update the European Medicines Agency (NYSEMKT:EMA). Anyhow, during the process before 2016, so that it is a multi-step process, and will take the amount of steps that are needed to satisfy regulators hopefully would good outcomes.
These steps would not involve a pre-approval CV outcome trial. That in my mind would only occur, that’s my personal view, would only occur in the event that the point estimate of all the things I just mentioned to you were attributing one. As it would take quite some drive from where we are today to bring it above one, as you recall from the CV analysis that was done as part of the Victoza approval process.
Lars Rebien Sørensen
Thank you very much. Next? And then later onto the growth expectation for 2013 and commenting on them in local currency terms. If we look at the growth in 2012, in local currency terms, it was 11.56. So, if you take the starting point of 11.5, then the first thing is, of course, that has been an issue for a while is the uncertainty surrounding the potential of having a generic compensation for our friends and executives in the U.S., that’s a percentage point from our sales and is expected to impact sales this year. We could have – we also believe that we chose rolling at slightly lower level in a more competitive environment in 2013.
And also, going from a bigger piece and hence the relative contribution being smaller in 2013, will drop another percent. And then you are down at around 9.5, which is the middle of the range. And then we could say, well on top of that, you may have some Tresiba effect. I think at this point of time and until we have the U.S. approval, we would like to be a bit conservative on that. On the other hand, you could say – on the negative side, we did have some significant contract wins. The (NYSE:KMR) contract, we spoke all about 2012. And it’s growth in the U.S., we are not going to have that growth eliminated in 2013.
So hence overall, the 9,5% mid-point feels comfortable. At this point in time, as we get through the year and hopefully get more clarity on Tresiba, we will have to revisit that again, but for this, the range we go with (inaudible) Thank you very much. There’s nothing, it was very, very clear. Ladies and gentlemen, let’s have your last question, please?
And we will take our final question from Brian Bourdot of Barclays. Please go ahead.
Brian Bourdot - Barclays
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 insulin skeleton, i.e., creating a true analog, while also you can say modulating the character of the subsequent your protection, i.e., the fatty acid side chain. And this is not being a trivial because we needed to make a – you can say a step change in the half life that we have seen from, for instance, Tresiba, to create an analog such as 287. This has been all benefit form that and that is in doing everything we have done, you also engineer a degree of metabolic stability into the molecule that may even lend itself to the use for all regimen, in which case you will have to benefit of the non-circulation half life, which can then buffer against the day-to-day variability for such an agent when given it already. When it comes to the pervasive times of Tresiba, if I should continue.
You will have to bear in mind a couple of things, Brian. If some of these times, and with very long review times, they are also precipitated by complete response that have been interjected. In the case of Victoza, the review time was 20 months, which we thought was a long time to be frank, but that was without a complete response later. And my view is that we are in this style of with agency and unless we get a complete response later, the dialog has progressed to an extent that going beyond ’13, without the complete response letter, would be somewhat of a surprise to me. Of course, I can speculate on the risk of a complete response letter, but I can speculate that we feel we have a very compelling case for a very safe analog, also on the various aspects that were discussed at the outcome. I think we presented that case part period as part of the outcome.
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.
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