Novo Nordisk A/S (NVO) Q3 2017 Earnings Report, Transcript and Summary

Thank you, Lars. Please turn to Slide 11. In August, we announced the SUSTAIN 7 trial results demonstrating that people with type two diabetes treated with once-weekly semaglutide experienced superior reduction in both hemoglobin A1c and body weight when compared to dulaglutide. With regard to A1c, patients on 0.5-milligram semaglutide achieved a statistically significantly superior reduction of 1.5% versus 1.1% with 0.75-milligram dulaglutide. People treated with 1-milligram semaglutide experienced a statistically significantly superior reduction of 1.8% versus 1.4% with 1.5-milligram dulaglutide. Moreover, the number of patients reaching the A1c treatment target were significantly higher for semaglutide versus dulaglutide. In fact, 49% of people treated with 0.5-milligram semaglutide versus 34% of people treated with 0.75-milligram dulaglutide reduced A1c to below the 6.5% target. For the top dose, 67% of people treated with semaglutide reached the goal versus 47% with dulaglutide. Furthermore, from a mean baseline body weight of 95 kilograms, people treated with the low dose of semaglutide experienced a statistically significantly superior weight loss of 4.6 kilograms compared to 2.3 kilograms with dulaglutide. People treated with the high dose of semaglutide experienced a statistically significantly superior weight loss of 6.5 kilograms compared to 3.0 kilograms with dulaglutide. For high- and low-dose semaglutide, respectively, 63% and 44% of patients achieved at least 5% weight loss with similar numbers for dulaglutide being 30% and 23%, respectively. Semaglutide was generally well tolerated with the most common adverse events being gastrointestinal. Incidence levels of retinal disease were balanced between semaglutide and dulaglutide. In conclusion, with this data set, semaglutide has now shown superiority over the two leading once-weekly GLP-1 products on both glucose and weight control. Please turn to Slide 12. In the third quarter, we've had three key regulatory approvals for our diabetes products. In August, the FDA approved the label update for Victoza based on the LEADER cardiovascular outcomes trial. Following this, Victoza is now the only GLP-1 receptor agonist with an indication to reduce major adverse cardiovascular events in people with type two diabetes. Furthermore, in September, our new fast-acting mealtime insulin, Fiasp, was approved in the U.S. The fast-acting profile of Fiasp will allow for excellent postprandial glucose control and more flexibility regarding when to take the mealtime insulin. Moreover, in September, we received an update of the EU Tresiba label, which now includes results from the large blinded DEVOTE trial investigating CV outcomes and severe hypoglycemia in patients treated with Tresiba versus insulin glargine U100. Regarding hypoglycemia, patients in the Tresiba group experienced a 40% overall rate reduction of adjudicated severe hypoglycemia. Moreover, a 53% reduction in the rate of adjudicated nocturnal severe hypoglycemia was observed. These differences were all highly statistically significant and are now integrated in the European label. Regulatory feedback in the U.S. is expected in the first quarter of next year. Please turn to the next slide. In October, we received a positive 16 versus zero FDA Advisory Committee vote with one member abstaining in favor of the approval of once-weekly semaglutide to improve glycemic control in adults with type two diabetes. The panel members were asked to discuss whether Novo Nordisk has provided adequate evidence to establish the efficacy and safety profile of semaglutide for the treatment of type two diabetes in adults. Following this positive outcome, the regulatory agency dialogue will continue with the expected FDA action date late this year. Within hemophilia A, we have completed the main phase of the guardian 4 trial with NovoEight evaluating the safety and efficacy in previously untreated patients below the age of six. The results show that 42.9% of patients developed an inhibitor, which is within the range of expectations for the patient population recruited for the trial. Analysis further demonstrated that the presence of a high-risk gene mutation was identified as a risk factor for inhibitor development. No other safety concerns were observed in the trial. Finally, we've initiated two Phase II trials for subcutaneously administered concizumab with the objective of demonstrating that concizumab is effective in preventing bleeding episodes in comparison to on-demand treatment, and further, to investigate the safety profile of the product in hemophilia patients, both with and without inhibitors. The studies are expected to complete next year. Please turn to Slide 14. Within this quarter, we expect to receive regulatory feedback on once-weekly semaglutide in both the U.S. and EU. So far, 2017 has been a positively eventful year with important label updates for Tresiba and Victoza, new product approvals, compelling Phase II data for semaglutide in obesity and type two diabetes, and last but not least, the positive vote for semaglutide by the FDA Advisory Committee. With this, over to Jesper for an update on the financials.

Thank you, Mads. Please turn to Slide 15. In the first nine month of 2017, sales increased by 2% in Danish kroner and by 3% measured in local currencies. The gross margin was 84.6% measured in Danish kroner, slightly lower than the level in 2016. The gross margin was negatively impacted by lower prices in the U.S. as well as slightly lower capacity utilization. The gross margin was positively impacted by a contribution from product mix due to higher Tresiba and Victoza sales. This was partly countered by lower sales of Vagifem, following the launch of a generic version in the U.S. Sales and distribution costs decreased by 2% in Danish kroner and by 1% in local currencies. This reflects lower manning and lower spend for promotional activities in the U.S., following the Tresiba launch in 2016 as well as broad cost control initiatives. Research and development costs decreased by 1% in Danish kroner and remained unchanged in local currencies. This reflects higher development costs driven by the PIONEER program for oral semaglutide. This is partly countered by lower costs following the completion of the DEVOTE trial and lower research costs following the updated R&D strategy announced in October 2016, which led to the discontinuation of a number of research projects. Administration costs declined by 5% in Danish kroner and declined by 4% measured in local currencies. The lower administrative costs are mainly related to general cost control initiatives. In the third quarter, we had a positive contribution from the divestment of an inflammation asset to Innate Pharma in France. This is reflected in other operating income, which, in the first nine months, increased by 39% in Danish kroner and by 41% in local currencies. Operating profit increased by 5% in Danish kroner and by 6% in local currencies. Net financial items showed a loss of around DKK 800 million compared with a loss of around DKK 400 million in 2016. This development reflects a loss on foreign exchange hedging contracts, especially for the U.S. dollar and Chinese yuan versus the Danish kroner primarily in the first half of the year. Diluted earnings per share increased to DKK 12.03, corresponding to an increase of 5% in Danish kroner. Please turn to Slide 16. The recent development in currencies impact Novo Nordisk's results reported in Danish kroner in 2017. However, in line with our treasury policy, the most significant foreign exchange risks have been hedged primarily through foreign exchange forward contracts. Since the Q1 report for 2017, we have seen a significant depreciation of the U.S. dollar versus the euro and the Danish kroner and most other key invoicing currencies. As a consequence, reported operating profit in 2017 is now expected to be negatively impacted by 3 percentage point. The depreciation of currencies is reflected in our guidance, which I will now turn to. Please turn to Slide 17. For 2017, sales growth is now expected to be in the range of 2% to 3% growth compared with the previous range of 1% to 3% growth, both measured in local currencies. This reflects the expectations for continued robust performance of Victoza and Tresiba as well as a positive contribution from Saxenda and Xultophy. These sales drivers are expected to be countered by an impact from lower realized prices in the U.S., driven by the basal insulin and growth hormone segments. Reported sales growth is now expected to be around 2 percentage point lower than the local currency level. Operating profit growth is now expected to be in the range of 3% to 6% growth measured in local currencies, compared to the previous expectation of a growth in the range of 1% to 5%. The increased expectation for higher operating profit growth primarily reflects the improved outlook for sales growth, but also a continued positive effect from cost control measures. The outlook for operating profit also relates to an expected increase in sales and distribution costs towards the end of 2017 to support launch preparations for semaglutide as well as sales growth initiatives. Moreover, it reflects an increase in research and development costs to support the progress of the pipeline. Reported operating profit growth is now expected to be 3 percentage points lower. Furthermore, we now expect financial items to be a loss of around DKK 300 million. The current expectations reflect losses associated with nonhedged currencies, partly offset by gains on foreign exchange hedging contracts mainly related to the U.S. dollar and Chinese yuan versus the Danish kroner. The effective tax rate for 2017 is expected to be in the range of 21% to 22%, which is broadly in line with the statutory corporate tax level in Denmark of 22%. Capital expenditure is now expected to be around DKK 9 billion in 2017. The investments are primarily driven by the construction of an active pharmaceutical ingredient production facility in Clayton, North Carolina. This ongoing investment is estimated to be around USD 2 billion and is expected to be completed in 2020. Furthermore, depreciation, amortization and impairment losses are now expected to be DKK 3.5 billion compared with the previous estimate of around DKK 3 billion, reflecting a slightly higher level of impairment charges in relation to our product supply activities. For 2017, we now expect the free cash flow to be between DKK 30 billion to DKK 34 billion. With regard to the financial outlook for 2018, we expect to provide detailed guidance in connection with the release of the full year financial results for 2017 on the 1st of February 2018. However, the preliminary plans for 2018 indicate low to mid-single digit growth in both sales and operating profit measured in local currencies. The preliminary plan reflects the expectations for continued robust performance of Victoza, the new generation insulins and modern insulins, Saxenda, as well as the expected launch of semaglutide. The sales growth is expected to be partly countered by intensifying global competition both within diabetes care and biopharmaceuticals, especially within the hemophilia inhibitor segment as well as a continued pricing pressure within diabetes care, especially in the U.S. Sales growth for 2018 reported in Danish kroner is expected to be 3 percentage points lower. And the reported operating profit growth is expected to be 4 percentage points lower. Please turn to the next slide. Based on the increased expectation for cash flow generation in 2017, the share repurchase program has been expanded with DKK1 billion. Previously, the program was up to DKK16 billion and now it will be DKK17 billion for the year. This concludes the financial update. Now back to you, Lars. Lars Fruergaard Jørgensen: Thank you, Jesper. Please turn to Slide 19. We continued to lever -- we continued to deliver on our plan for 2017, and we are very pleased with the recent clinical and regulatory progress for our key products. We are currently preparing for the global launch of semaglutide, which offers a unique opportunity to improve the treatment of people with type two diabetes. We are now ready for the Q&A. [Operator Instructions] Operator, we are now ready to take the first questions.

[Operator Instructions] Today's first question is coming from Mr. Vincent Meunier calling from Morgan Stanley. Please go ahead.

Actually, I have two questions on your 2018 outlook. I mean, you referred to intense global competition within diabetes care and biopharmaceuticals and continued pricing pressure within diabetes. Can you please, I mean, comment on the pricing assumptions you have for '18 for the diabetes segment, and more particularly for the GLP-1 one? And also, your guidance suggests that the margins will be stable next year. Can you give more comments on the dynamics for the different cost lines? Lars Fruergaard Jørgensen: Thank you, Vincent. So first, on the pricing. We are not in a position to go in and comment specifically on price development. We do not think that's meaningful in isolation as what we end up selling is a combination of price and volume and mix, so commenting specifically on one of the elements is not really meaningful. So unfortunately, we cannot do that. Jesper, in terms of margin development and cost line items?

Thanks, Lars. Yes, currently, in relation to 2018, of course, the detailed cost guidance will come in February. But I mean, high level, I do -- can provide some flavor on what is expected in terms of the development in individual cost items based on the overall assumptions, as you rightly point out, that with a similar level of growth in sales and operating profit, the operating margin will be unchanged. Now if we look to the lines, the development in our gross profit and gross margin, there we are likely to see a slight negative development similar to the approximately 50 basis points guidance that we've given for 2017. The exact level of decline we would like to defer to October. In terms of the selling and distribution ratio, we would assume that we will there be in the vicinity of where we are also expected to be this year, which is in the 25% to 26%. But of course, that can be very dependent on what exact portfolio we are going to launch and at what point in time will it be possible for us to start be aggressive in marketing of the portfolio. R&D ratios, I think our historic assumptions have been that we will be in the vicinity of 13%, but gradually ramping up towards that level whereas, on admin, we have seen a historic gradual improvement in the admin ratio and that should also be expected to continue. As for other operating income, that is very dependent on individual events and I would like to defer giving a more specific growth outlook for that or a number outlook for that until we get to February. But overall, I think the balance of what we do, the cost control initiatives that we have will enable us to manage the cost structure to a operating margin that's going to be largely unchanged compared to the operating margin that we anticipate for this year and which is inherent in the guidance we have provided for 2017, noting that we are expecting a substantially higher investment level in selling and distribution costs in the final quarter of the year, which is built into our guidance for 2017. Lars Fruergaard Jørgensen: Yes. Thank you, Jesper. And just on the pricing, just to reiterate what we have said before that, although we do not comment specifically on pricing, we do see a continued erosion of pricing in the basal category. Just to make that clear.

[Operator Instructions] Today's next question is coming from Wimal Kapadia calling from Bernstein. Please go ahead.

Wimal Kapadia from Bernstein. The first question is the Levemir sales declined -- the decline increased in 3Q, particularly in the U.S. and in Europe. I'm just trying to get a better understanding of the moving parts that are driving this decline. So how much is price? How much is competition from BASAGLAR and other competitors? And then how much is actually driven by the growth of Tresiba? And then just one for Mads on concizumab. It seems like TFPI levels differ quite significantly across populations and there are different items as TSPI exists at different concentrations within the body. So I guess I'm just trying to determine whether that implies that efficacy could vary quite significantly across patient populations and will that mean titration will be quite complex? Lars Fruergaard Jørgensen: Thank you very much. Jesper, firstly, on the quarterly splits, noting that it is -- one has to be careful about looking at quarter by quarter as there are adjustments being made.

Yes. The development in Levemir between Q2 and Q3 this year was largely linked to a adjustment of rebate in Q2 this year and a adjustment to rebate in the opposite direction in Q3 last year, and hence, when you look to the growth compared to last year, that was very weak. What you should assume for Levemir is that it is gradually being cannibalized. We see it primarily happening due to competition from our Tresiba and not so much as switching to BASAGLAR. It's relative few places in the U.S. where there has been a adverse reimbursement reaction occurring to Levemir. It is broadly unchanged in reimbursement and hence that's not a significant driver for switching Levemir patients to BASAGLAR. But of course, there is, in the reported sales also compared to last year, a quite substantial negative rebating effect that basically reflects the efforts of Novo Nordisk in keeping Levemir reimbursed also in 2017. Lars Fruergaard Jørgensen: Thank you, Jesper. And over to Mads on concizumab.

Yes. Well, it's a really good question and this is, of course, pretty new biology. So we've done, you can say, almost, what I would call, classic textbook pharmacology in human beings in one of the first studies, namely, the Explorer 3 trial where we actually investigated the correlation between concizumab levels and free TFPI and how that impacted the thrombin generation and the propensity of the patients to bleed. And you're absolutely correct in stating that free TFPI levels as well as endothelial cell bound levels of TFPI actually differs between patients and this is something we're still exploring. What we found, though, is that when you have a concizumab level above 100 micrograms -- or nanograms per millimeter, then we see a very nice thrombin generation in the classic thrombin generation test and also very, very few bleeding episodes. So our belief is that we have to operate in the vicinity of somewhere between 100 micrograms -- or nanograms per milliliter and to the tune of 200 to 300 or so, then we'll be at easy 80 to 90 level. So basically, we've defined the window and the way we get there is by dosing as we're doing in those two trials, but this is still exciting work in progress and we can update you with much more specifics from bigger patient populations during the course of 2018.

The next question is coming from Mr. Florent Cespedes of Societe Generale. Please go ahead.

A few quick ones, first on Tresiba. Could you elaborate on the recent changes in the U.S. because you flagged that there will be some volume opportunities? Could you give a little bit more color on what about the net potential impact to the value component? A follow-up on Tresiba in Europe. Could you give us more color on how you will leverage the Tresiba label update? Which countries should benefit the most? And my last question, a general question, M&A, for Lars. Last year, you announced that you would be more open to consider some, let's say, in-licensing or inorganic growth to transform your portfolio. Now one year down the road, could you tell us what has been done and which areas you are still exploring and why have you not found any opportunities so far? Lars Fruergaard Jørgensen: I think, three questions actually. Let me try to address them all. If you -- the first one, in terms of contract coverage in the U.S. for Tresiba, you're right that in the CVS -- with CVS and in the Medicare Part D segment, there has been a change for Sanofi in the sense that Lantus and Toujeo are excluded. We keep our Tier 2 position together now with BASAGLAR and that was obviously opened up around 10% of the second volume that we'll have to land on -- where patients will have to go to another product. So this is an opportunity similar to what we saw in the beginning of the year. Obviously, the dynamics is slightly different. For one, you can say BASAGLAR is a better-known product by now. On the other hand, we are out talking to the hypo benefit of Tresiba, which creates maybe a preference for Tresiba and also that the dynamics in Medicare Part D and commercial is also slightly different in terms of what are some of the counter-strategies that Sanofi can apply. We cannot be more specific in terms of volumes or value we expect to get out of this. This will unfold over the coming month. With regards to within Europe where we have the label update and now can go out and push the hypo benefit, this is something we're going to prioritize in all markets because it's really a meaningful differentiation for patients that you can reduce the risk of a hypo by 40% and the risk of a nocturnal hypo by more than 50%. So this is what patients and physicians worry the most about when you start treating diabetes with insulin, getting a hypo, so we are bringing that benefit now out to patients in all countries where we have Tresiba approved. On M&A and licensing, it's correct that, in particular, in the biopharma space we are looking to bolt on external innovation, both clinical assets early innovation, but potentially also products that have -- are close to market or just launched. We have a kind of a disciplined approach here that we believe that we need to be good owners, i.e., we need to be able to add value to such assets, i.e., it needs to be in fields where we have a commercial presence, we have clinical competencies or in other ways can add value, which makes it a relative narrow field of opportunities we can pursue. And that's why you have to be a bit patient in landing a potential deal because we are not going out and doing desperate transactions where it will not be attractive for shareholders also in terms of growth going forward. So we're working on it, but this is something that takes time and we stay disciplined in what we do.

We now go to Mr. Peter Verdult of Citi.

Pete Verdult with Citi. Just three very quick questions, if you allow me. But just on -- if we assume parity pricing between sema and Victoza, is there any gross margin differentials to consider? I know -- like we've seen like with Tresiba and Levemir. So that's question number one. And number two just quickly on tax. I think you're the only company out there that's given some sort of sensitivity about what would -- the impact would be of U.S. tax reform. I just wanted to confirm that the -- for every 10% lowering of the U.S. corporation tax is a 1% benefit on Novo's group tax rate. Does that still hold as the current [plan C]? And then lastly, apologies for the format. I just wanted to sort of go forward one year, just think when you think about the probability of Novo ending up being the only company with GLP-1 that demonstrates a CV benefit, do you think that's a realistic scenario or a low probability event? Lars Fruergaard Jørgensen: Okay. Yes, Jesper, go ahead.

First, on the -- what is going to be the gross margin for semaglutide and, I'm not going to buy into your specific assumptions surrounding what the specific pricing point is going to be because, of course, we are talking about a net pricing point and that's too early to tell. But if we kind of just basically use what is the general pricing points of the GLP-1, what should one assume. And then, clearly, it will be a while before we will be at the level of a gross margin that we have achieved for Victoza, which is above our average. But that's also following a very, very successful penetration and then turning it into a triple blockbuster product with the inherent scale advantages that come from this. Also bear in mind that we are launching semaglutide in a more advanced device, that is inherently somewhat costly. So my best guess would be that it will at least take us 3 years to get it towards the margin levels implied for Victoza and we're absolutely comfortable with that. It's still going to be at GLP-1 price level. It's going to be a very attractive proposition for Novo Nordisk shareholders. And we do believe that the inherent clinical benefits of the product merits a attractive pricing. So I wouldn't be overly concerned about that. I didn't fully get the second question, so does that... Lars Fruergaard Jørgensen: U.S. tax reform.

The U.S. tax reform. Basically, it is positive for us, but the current taxation that we have in the U.S. is about 10% of total tax. So from there, you can basically work out what the approximate implication will be from changes in the tax rate, but generally speaking it is positive. It looks to me like what was my prime concern, the border adjustment tax regulation, that seems to be taken off the schedule. And as long as that's the case, then it looks like this is now turning from being a significant risk to being a slight upside. But I think the devil is in the detail and I don't think that we have yet seen the U.S. administration clearly outlining how the financing will be of the lowering of the U.S. tax rate and hence what changes to the deductions available. And also, and to me, very importantly, with the very substantial investment we're doing in North Carolina, what tax benefits can I get from such a large investment? That's still out. But on the borderline, it looks positive and use kind of the rule of thumb that at approximately 10% of total corporate taxes paid in the U.S., then you get close to implication. Lars Fruergaard Jørgensen: Thank you, Jesper. And Mads, on CV perspective across the GLP-1 class.

Yes, that's a really important question, Peter. And if you look at the historic facts, we have a situation where the two genic-like peptides, lixisenatide, the modified version, actually has shown totally superimposable data compared to placebo in their trial. And then you have the exenatide that has been tested in two versions, both in the ITCA-650 osmotic pump device in the FREEDOM trial and also as the once-weekly extended release version, BYDUREON, in the EXSCEL trial. The FREEDOM did not show any superiority. The EXSCEL trial was similar to DEVOTE in that there was a 9% non-significant reduction in the risk of major adverse cardiovascular events. So far, you can say nothing has happened outside of liraglutide and semaglutide, the two isolated human GLP-1s that we are producing. Then there's albiglutide that has been pulled from the market, but they promised to continue their ongoing trials, so we'll see. REWIND is the interesting one on dulaglutide, and do bear in mind that dula is a very different molecular species from the isolated Novo Nordisk molecules, but it's also a whole different population. These people have had shorter, relatively speaking, duration of diabetes, only about 10 years. They have a low A1c of about 7.3%, which is more than a percentage point lower than the Novo Nordisk lira in SUSTAIN 6 trials. And the most important maybe is the difference in the cardiovascular predispositions in that only 31% of the REWIND population has existing cardiovascular disease at baseline. This implies -- and we do know from our trials at least that for our compounds, the established cardiovascular disease actually was the population where we saw the really strong benefits. So it will be very difficult to read over at all, both from the molecular perspective and also from the baseline characteristics of the population perspective, any findings from our compounds. That's as far as I can say. So if dulaglutide does not show a significant benefit come the next few years, then you're right, it will then be lira and sema that are the ones in the GLP-1 class. We cannot at this point, that's for sure, say that cardiovascular protection is by any means a measure anything close to being a class effect of the GLP-1 agonists.

We now go to Trung Huynh of Crédit Suisse. Please go ahead.

Firstly, what are your expectations for Sanofi potentially launching a biosimilar Humalog for next year and is this factored into your guidance? And also can you discuss your sales and marketing priorities for next year in the U.S.? Presumably, you'll start off with sema, but should we expect a more full rollout for Xultophy and your ultrafast-acting insulin early on as well given that they're available? Lars Fruergaard Jørgensen: Thank you. Obviously, when we provide guidance, we include, say, the upside and downside scenarios in that guidance so that is included. It will be interesting to see the contracting dynamics in the fast acting category is quite different from what we see in other categories where there's a highest rebate level given and also the highest degree of exclusive contracts. So that's what we can say for now. When we talk about sales and marketing approaches for 2018, the priorities will be centered around the largest growth drivers and then launching semaglutide. So in semaglutide, we probably have the biggest opportunity we have ever had in Novo Nordisk. We have invested a lot in the clinical program, we have a very strong profile and we'll be going, so to say, all-in on that when we have opportunity. During the year, there'll be a step-up when we get to the second half of the year where we can start doing a D2C, which we cannot do in the beginning of the year, so the type of activity will be a bit different across the year. We'll keep focusing on Tresiba. We still believe Tresiba has a significant potential in the U.S. and obviously it's an aspiration of ours to fully leverage the hypo data, so a significant priority will also be given to Tresiba. Saxenda is also contributing nicely, so we'll also be focusing on that. We will obviously also be launching the long-acting insulin, aspart -- the fast-acting insulin, aspart. But again, based to the discussions we had before about the contracting, et cetera, this is something that the commercial activity would be a bit different from the launch of, for instance, semaglutide. So that's what we can say on that for this morning. Thank you for the question.

We'll now go to Sachin Jain calling in from Bank of America. Please go ahead.

I've actually got a couple of clarification questions on most topics that we've discussed. And so firstly, on Part D basal insulin, obviously talking to a volume benefit potential in '18. Would that also be a value benefit next year? Or do you think about the contracting in Part D more midterm? And then related, as we think about the volume benefit from Part D, how does that play into your sort of 5% volume share gain per year that you sort of generally framed for Tresiba? Secondly, on semaglutide, you've talked about gradual access, just from the wires this morning. So just -- I wanted to tie that back in to the sales and distribution comment that you made. Does that fit with that being a priority for S&D? And any color why access should take time given the very compelling profile of the product? And then final question for Mads on REWIND. Completely understand your commentary, it's a very different patient population and therefore can't extrapolate the probability of success. But if that study did work, could you comment on the commercial impact given that you've very deliberately set it up as a frame in a much broader population in the diabetes setting than your high-risk patient population in LEADER? Lars Fruergaard Jørgensen: So on the Part D access, I think I explained what the dynamics is and it's approximately 10% segment share that's in play here. When we provide our guidance, we know we factor in price, volume, mix so I'd not really go in and talk to, say, the value part of it. Obviously, there is a opportunity here to grow our share of the market and -- or grow our sales based on it, but it's also well known that the price point in -- from a price point of view is lower in Part D. But I cannot be more specific compared to the overall guidance we have provided before. Jesper, you touched upon gradual uptake on semaglutide before?

Yes. It was basically just acknowledging whenever you bring a new product to market and you do it out of the season negotiations for the access, which basically starts already in end of Q1 for the Part D for the following year and April, May-ish for the access in the private space for the following year, of course, you will -- your access will only be gradual during 2018 and you will have a number of plans where you get initial Tier 3 access as a new product and we will, of course, pursue those opportunities. We have a couple of PBMs where it will be feasible for us to go into direct negotiation about having a reimbursement at an earlier point in time. So I can't say anything more specific that this will be tactical and a negotiation plan by plan, but of course also very linked to the quality of the clinical label that we get. And we really look forward to have those discussions. We feel that it will be a good investment of our shareholders' money to establish a strong position in the mindset of both the endocrinologists, but certainly also the general practitioners of the significant benefits that they can go for -- get from semaglutide. So I'm not ruling out that when we get to second half of 2018 that a D2C effort on semaglutide could be called for. But that would, of course, be tactical and based on an assessment of what reimbursement situation we will be looking at that point in time, I think that will be a decision we will take. I don't think I can say anything more in terms of the level of S&D other than we think it is realistic from the level that we are also estimating for 2017. So it will, to a large degree, be a prioritization of the resources and with that also comes the assumption that we don't see any significant changes in the size of the U.S. sales forces, but of course a high degree of focus from the sales force on semaglutide in 2018. And then, Mads, I think the final one was yours.

Yes. So I think, Sachin, that one has to look at this both from a regulatory perspective and a treatment guideline perspective and an overall disease biology perspective. And there's no doubt that the whole process underlying the atherosclerosis that people with cardiovascular disease and diabetes suffer from is the same whether you take early or late stage. It's just the time to event that may differ, whether you have a plaque or have no plaque and whether or not you influence the stability of that plaque, if you have one. These are biological issues that will be extremely interesting to tease out as these studies unfold. In terms of the impact of whether REWIND shows -- in the event REWIND shows positive data, the way that we read the treatment guidelines as they're unfolding now in a multitude of European countries, but also in Canada and the United States and emerging also in other countries, is that typically those guiding treatment of the future tend to see people either at high risk of cardiovascular disease, i.e., people with type 2 diabetes and several risk factors or whether they have established CVD with a prior event, pretty much as a slightly undefinable mixed bag of high-risk patients. So we'll simply have to see how regulators and how treatment guideline providers handle data from that specific study. It's more relevant, I guess, that you discuss it with our friends at Eli Lilly. I can most comment on semaglutide where SUSTAIN 6 is, in essence, only the beginning of a long adventure into both new therapy areas, but also potentially more outcome trials as we have mentioned previously.

We now go to the Kerry Holford calling in from Exane.

Two quick financial questions, please, for me. Firstly, disposal gain, can you quantify what that was in Q3? What was within other operating income relating to the inflammation asset disposal? And secondly, on net financials. In the press release, you comment about DKK 2 billion of income that's been deferred from '17 into '18. Can you just elaborate what that relates to, why it's deferred? And does that then -- that deferral play a role in your now lower, now more negative net financial guidance for 2017?

Thanks, Kerry. First, on the disposal, that's basically related to an asset within -- we developed for inflammation, C5aR, which has been transferred to the French biotechnology company, Innate Pharma. It has actually also been announced by Innate Pharma that they have acquired that, it's a listed company in Paris. And we obtained shares in Innate Pharma for that -- for them taking over that asset, which basically took our shareholding in Innate Pharma from 10% of the total shares to about 15%. And it's the value of that increase in our shareholding in Innate Pharma that is reflected in the other operating income recorded in Q3 over and beyond the continued royalty flows we have from various IP agreements, both within diabetes care and hemophilia. So that's the other operating income. In terms of the net financials, well, inherently, when you close your books, you will have a portfolio -- or with the principle that Novo Nordisk have of hedging our forward cash flow exposure in the major currencies outside the Danish kroner Eurozone like primarily U.S. dollar, but also Chinese yuan, you will have a positive or negative market value of those whenever you close your books. That positive or negative market value is being deferred for income recognition when the actual cash flows are being realized. So what I just mentioned in our financial line as per 30th of September was the fact that there was approximately DKK2 billion in positive market value of these contracts and that was basically reflecting that you saw a substantial depreciation of the U.S. dollar and the CNY and we had purchased those forward contracts when the U.S. dollar and CNY levels were significantly higher, hence, a positive value of the contracts. Of course, that has moved from the 30th of September up until the day of guidance that we provided for our guidance for 2017 full year and also the basis for our assessment of 2018, and that's why we say specifically that we now anticipate an approximately DKK600 million positive effect on 2018. But do bear in mind that the positive value as per 30th of September of DKK2 billion, there is an element of that, that relates to income that's going to be recognized in the fourth quarter of 2017 and a full year 2018 effect. So the key number for you to really zoom in on is the DKK600 million that will be positive in the financial line because you have a very specific guidance on what is the financial line going to be for 2017, which we have updated and now state that that's DKK300 million and then you know that there is a positive hedging effect currently using the rates we have as per 27th October of DKK600 million and then other financial items typically is approximately minus DKK100 million per year and then you have a reasonable estimate for what the finance line will be in 2018. I hope that clarifies that question.

Can I just ask a quick follow-up, sorry, relating to the disposal gain. Can you quantify what that was within other operating income?

Yes, it is in the vicinity of about €40 million. Lars Fruergaard Jørgensen: All right. Thank you very much. Before we go to the last very quick question, I would just like to remind you all that we are hosting a Capital Markets Day on the 21st of November where we hope to see you all.

The last question will be coming from Mr. Michael Leuchten calling from UBS. Please go ahead.

One question to follow-up on the basal insulin franchise. When I look at the combined U.S. constant exchange rate growth year-to-date, so nine months, if I do my math, that differential is up 2.5%, so that's Tresiba and Levemir, that doesn't quite tally with your commentary around taking 400 basis points in share and also your commentary around the cannibalization of Levemir into Tresiba. So how do I read that 2.5% CER growth year-to-date?

Well, where did you get those 400 basis points from?

I thought that's what I thought...

We lost you, Michael. Could you repeat the question, please?

Sorry. So the -- you talked about share increases for your combined Levemir-Tresiba franchise, but the combined constant exchange rate revenues in the U.S. are up 2.5% year-to-date. That doesn't quite tally with the share increase and the commentary between Levemir and Tresiba where you said most of the Tresiba volume is coming from Levemir. So I just wondered the 2.5% constant exchange rate growth, how do I read that relative to the other volume comments that you made?

I think there may be a slight misinterpretation because, of course, what we gained, which is, you could say, the 4% increase in the Tresiba share, we have lost a proportion of that on the Levemir share, so the net effect there is going to be in the 2 to 3 percentage point increase on a yearly basis. So I think there is actually a reasonable correlation, but I may not have gotten the question completely right. Lars Fruergaard Jørgensen: All right. With this, we'd like to conclude our conference call. Thank you for participating, and please feel free to contact our Investor Relations to ask follow-up questions you might have. Thank you for your attention, and have a good day. Bye-bye.