Novo Nordisk A/S (NVO) Q4 2017 Earnings Report, Transcript and Summary

Good day and welcome to the Q4 2017 Novo Nordisk A/S earnings conference call. Today’s conference is being recorded. And at this time, I would like to turn the conference over to Lars Fruergaard Jørgensen. Please go ahead, sir. Lars Fruergaard Jørgensen: Welcome to this Novo Nordisk Conference Call regarding our performance for 2017 and the outlook for 2018. I'm Lars Fruergaard Jørgensen, the CEO of Novo Nordisk. With me, I have our Chief Financial Officer, Jesper Brandgaard and our Chief Science Officer, Mads Krogsgaard Thomsen. Also present and available for the Q&A session are Executive Vice President and Head of Commercial Strategy and Corporate Affairs, Camilla Sylvest as well as Executive Vice President and Head of Business Services and Compliance, Lars Green. Furthermore and available for Q&A are Executive Vice President and Head of Investor Relations, Mike Doustdar and Senior Vice President and Head of Corporate Finance, Karsten Munk Knudsen, who as of 15th of February will assume the role as Executive Vice President and Chief Financial Officer. Present are also our Investor Relations officers. Today's earnings release and the slides for this call are available on our website, novonordisk.com. The conference call is scheduled to last for one hour. As usual, we'll start with a presentation as outlined on slide 2. The Q&A session will begin in about 25 minutes. Please note that this conference call is being webcast live and a replay will be made available on Novo Nordisk's website. Please turn to slide 3. As always, we need to advise you that this call will contain forward-looking statements. Such forward-looking statements are subject to risk and uncertainty that could cause 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. Please turn to slide 4. Sales in 2017 grew by 2%, measured in local countries and were unchanged in Danish kroner. International operations grew by 5% in local occurrences while sales in North America operations were broadly unchanged in local currencies compared to 2016. Sales growth came diabetes care and obesity with the main growth drivers being Tresiba, growing 85% and Victoza, growing 18% in local currencies. Turning to the R&D events, in December, Ozempic was approved in the US. In Europe, a positive CHMP opinion was issued, recommending marketing authorization of Ozempic. By mid-2018, we plan to initiate a cardiovascular outcomes study called SOUL for Ozempic. Within obesity, the Phase 3a program for semaglutide in people with obesity called STEP will be initiated in 2018. Furthermore, for semaglutide and obesity, we will initiate a large cardiovascular outcome study called SELECT. Turning to financials, the operating profit for 2017 grew by 5%, measured in local countries and by 1% in Danish Kroner. The diluted earnings per share increased by 3% to DKK15.39. At the annual general meeting, the Board of Directors will post a final dividend of DKK4.85 for 2017 per share. Moreover, the Board of Directors intend to initiate a new share repurchase program of up to DKK14 billion, which will be executed during the coming 12 months. With regard to the 2018 outlook, sales growth is expected to be 2% to 5%, measured in local currencies with an expected negative currency impact of 7 percentage point. The range for operating profit growth is expected to be 1% to 5%, measured in local currencies, however negatively impacted by currencies of 10 percentage points, primary reflecting the significant depreciation of the US dollar versus the Danish kroner. Please turn to slide 5. I’d like to highlight two changes to the leadership of Novo Nordisk. The Chairman of the Board, Göran Ando has decided not to seek reelection for the annual general meeting in March 2018. The Board of Directors has consequently decided to propose current member of the Board of Directors, Helge Lund to be elected as Chairman of the Board. Helge Lund has in total been a member of the Board of Directors for two years and has extensive management experience recently as CEO of BG Group in United Kingdom and as CEO for Statoil in Norway. Furthermore, as per 15th February 2018, Karsten Munk Knudsen, currently Senior Vice President of Corporate Finance will succeed Jesper Brandgaard as Chief Financial Officer. Jesper Brandgaard will continue as Executive Vice President, responsible and biopharma and legal affairs. Karsten Munk Knudsen started his career in Novo Nordisk in 1999 and has held finance positions of growing size and complexities throughout the Novo Nordisk value chain. From 2010 to 2014, he was Corporate Vice President responsible for finance and IT in the US. In 2014, he was appointed Senior Vice President responsible for Corporate Finance in Novo Nordisk. On this call, I would also like to thank Jesper. You’re handing over finance functions, which is in excellent shape and we have a new CFO who has learned from the best. I know that Jesper has meant a lot for the investment community the last 17 years and thanks for him we're known for our open and honest communication. I hope you welcome Karsten who is already familiar face for most of you and who will represent the continuity of our finance functions. Please turn to next slide. In 2017, the overall sales growth was 2.3% in local currencies and unchanged in Danish Kroner. This is in line with the latest guidance provided in connection with the announcement for the first nine months of 2017 in November. The sales growth was primarily derived from international operations which grew by 5% in local countries, while North America operations sales were broadly unchanged in local currencies compared to 2016. Within international operations, all regions contributed to growth. Sales in region AAMEO comprising, Africa, Asia, Middle East and Oceania increased by 8% in local currencies. The sales growth was largely driven by modern insulin, Victoza and Saxenda, partly countered by lower biopharm and human insulin sales. In Region Europe, sales increased by around 4% in local currencies. Sales were driven by Xultophy and the continued penetration of Tresiba. This was partly offset by declining Levemir sales reflecting the continued rollout of Tresiba. Region China grew by around 6% in local currencies. The sales growth were driven by a continued growth in modern insulin sales which was partly offset by declining human insulin sales. Sales growth in Latin America of around 7% measured in local currencies was driven by Saxenda, Tresiba and modern insulin, partly offset by the timing of tenders for human insulin and NovoSeven. Moreover, sales was positively impacted by 9 percentage points due to price effects in countries with high inflation. In North America operations, sales were driven by Victoza and Tresiba due to underlying volume growth in both the GLP-1 segment and the basal insulin segment as well as market share gains for Tresiba. This was countered by lower Levemir sales and lower realized prices for basal insulin. In line with expectations, sales in North America operations were negatively impacted by approximately 4% due to the launch of generic version of Vagifem and non-recurring rebate adjustments in 2016 related to Norditropin. Please turn to slide 7. From a product perspective, sales growth in 2017 was derived from the diabetes care and obesity franchise, but negatively impacted by a decline in the biopharma franchise. In 2017, sales of Tresiba reached DKK7.3 billion and has since achieved blockbuster status. Meanwhile, sales of Levemir declined by 15% in local countries, partly due to the continued rollout of Tresiba. Sales of Xultophy reached DKK729 million in 2017 compared with 207 million in 2015. Xultophy is currently marketed in 18 countries. Victoza sales increased by 18% in local currencies, driven by the US where we totally grew by 22% in local countries. This reflects an underlying prescription volume growth of the GLP-1 class and a positive impact from higher realized prices. Furthermore, sales is perceived to be positively impacted by the updated product labor, reflecting the reduced risk of major cardiovascular events. Sales of Saxenda increased by 64% in local currencies and reached DKK2.6 billion. With that, Saxenda has reached a global market leadership position within obesity treatment with a value market share of 37%. Saxenda has now been launched in 25 countries. Sales of biopharmaceutical products declined by 16% measured in local currencies. This was mainly driven by declining Norditropin sales and a negative impact on Vagifem sales due to the launch of a generic version in the United States, whereas sales of hemophilia grew by 2% in local currencies. Please turn to slide 8. Tresiba has now been launched in 62 countries with a positive uptake in countries with the same level of reimbursement as insulin glargine U100. In countries where Tresiba has subsequently -- in countries where Tresiba and subsequently Xultophy has been launched, Xultophy has contributed to continued growth and market share gain in the basal insulin segment. I think sample Tresiba has obtained a market share of 28% in Switzerland and when combining Tresiba and Xultophy, the total value market share is 59% in the basal insulin segment. In France, Xultophy has reached a value market share of 14% in the basal insulin segment since the commercial launch in January, 2017. Lastly, Xultophy was launched in the US in May 2017 and the rollout is progressing as planned. Please turn to slide 9. Since the beginning of 2017, the combined volume market share of Tresiba and Levemir in the US has increased to a total of 34%, with Tresiba having grown by approximately 5 percentage points. With that ambition to reach 10% Tresiba volume market share in 2017 was successfully achieved. Tresiba has now reached a total volume share of 10.7%. This is driven by a strong penetration in the commercial channel, while their performance in the Medicare Part D segment has been modest so far. The formulary changes in the Part D segment as of January 2018 for computing basal insulin products have provided Tresiba with an opportunity for further growth in its market share. Please turn to slide 10. Victoza sales increased by 18% in local currencies, mainly driven by the US. In the US, Victoza sales increased by 22% in local currencies with the primary driver being the underlying growth in the US GLP-1 market. In the fourth quarter of 2017, sales have also been positively impacted by the updated product labels, reflecting the reduced risk of major cardiovascular events. With this, over to Mads for an update on R&D.

Thank you, Lars. Please turn to slide 11. In December last year, once-weekly Ozempic was approved in the US and a positive CHMP opinion was issued in Europe, recommending marketing authorization. Both the US and the EU label reflect that Ozempic has demonstrated clinically meaningful and statistically significant reductions in hemoglobin A1C as well as statistically significant reductions in body weight versus a multitude of competitors. In the United States, Ozempic is approved for use in two therapeutic doses, the half and 1 milligram and will be launched in the Ozempic pen, the latest generation of prefilled device. Ozempic has demonstrated a safe and well tolerated typical GLP-1 class profile across the sustained program with the most common diverse event being nausea, which diminished over time. In the US, wording around retinopathy was similarly to insulin products added in the warnings and precautions section of the late. Cardiovascular results from SUSTAIN 6 with the number and percent of MACE events for the Ozempic and Tresiba groups are included in the clinical section. In Europe, CHMP has incorporated all key sustained trial results including cardiovascular data from SUSTAIN 6 in the Ozempic label. Similarly, to the LEADER data in the Victoza label. The Ozempic European label hence includes the 26% risk reduction of MACE as well as Kaplan-Meier plots. The wording around retinopathy in the EU label is similar to the US and we have as part of the EU approval committed to conduct a long-term diabetic retinopathy outcome study, which will power to enable documentation of a potential long term benefit of Ozempic on retinopathy. The EU Commission approval is expected during the first quarter. Finally, related to semaglutide in the SUSTAIN program, we happen to know that the SUSTAIN 7 comparator trial versus dulaglutide has been published today in The Lancet D&E. Please turn to the next slide. Following the approval of Ozempic, we plan to initiate a large global cardiovascular outcome study termed SOUL. The study will enroll around 13,000 people with Type 2 diabetes and established CV disease or chronic kidney disease. It is a superiority trial, designed to confirm the findings in SUSTAIN 6 by showing a significant reduction in the number of major adverse cardiovascular events in people treated with Ozempic compared to placebo, both in addition to standard of care. The trial is expected to be initiated mid-year. Please turn to the next slide. Following the positive Phase 2 obesity data with semaglutide, we are initiating an extensive Phase 3a program called STEP. Around 4500 people fulfilling agency requirements for enrolment into obesity trials will be included in the program consisting of four clinical trials with a duration of 6 to 8 weeks and expected to be completed in 2020. In addition, we plan to initiate a large cardiovascular outcome study named SELECT in approximately 17,500 people with obesity. The aim of SELECT is two-fold, since we both seek to establish semaglutide as a cardio-protective agent in a non-diabetic population and furthermore, to demonstrate for the first time ever that pharmacotherapy improves long term outcomes in obese patients in a landmark study. Please turn to slide 14. In September of last year, the onset 5 phase 3b trial with Fiasp in people with type 1 diabetes was completed. The trial objective was to confirm the effective continuous subcutaneous infusion treatment with Fiasp in terms of glycemic control and compared to NovoRapid. In the study, Fiasp was confirmed to be non-inferior to NovoRapid with regard to change from baseline in hemoglobin A1c and the safety profile of the two products was similar. Early this year, the DUAL III Japan Phase 3a trial with Xultophy was completed. The trial successfully achieved its objective by demonstrating that treatment with Xultophy was superior to Tresiba with regards to lowering of HbA1c with an A1c reduction of almost 2% to an end of trial hemoglobin A1c of 6.7%. Furthermore, from a mean baseline body weight of 74.7 kilograms, people treated with Xultophy experienced a weight loss of 0.7 kilos compared with a weight gain of 0.7 kilos for people treated with Tresiba. Corresponding to a statistically significant treatment difference of 1.4 kilograms in favor of Xultophy. We plan to submit a new drug application for Xultophy to the Japanese authorities in the second half of this year. In Japan, we additionally submitted a supplemental application for inclusion of the data from the DEVOTE trial in the label for Tresiba. Furthermore, in November of last year, a variation application was submitted to the EU authorities to include data from the LEADER and DEVOTE cardiovascular outcome trials in the Xultophy label. In December, we completed the Phase 3b trial with Japanese people with type 2 diabetes inadequately controlled on once daily Victoza 0.9 milligram and escalated to 1.8 milligram. Upon completion of the trial, HbA1c was statistically significantly lower with Victoza 1.8 milligram compared to the low dose. In December 2017, we submitted an update of the Saxenda label based on LEADER data to the FDA as an efficacy supplement for Saxenda. The submission was based on the results from the LEADER trial. Finally, we’ve now completed recruitment of people with hemophilia A for the explorer 5 trial with concizumab intended for prevention of bleeding episodes after subcutaneous administration. Explorer 5 is a global open label trial including 30 people with hemophilia A and the trial objective is to demonstrate proof of concept that is to say that concizumab is efficacious in preventing bleeding episodes. Explorer 5 is expected to report in the third quarter of this year. Please turn to slide 15. By the end of the first quarter, we expect to receive regulatory feedback from the FDA regarding the inclusion of hypoglycemia data from SWITCH and DEVOTE in the label for Tresiba in the US. We also expect to complete the Japanese DUAL I within the first quarter, enabling a submission of Xultophy to PMDA in the third quarter of this year. Furthermore, regulatory approval of Ozempic in Europe and Japan is expected during the first quarter of this year. Similarly, in the first quarter, we expect the first results from the large phase 3a program for oral semaglutide. PIONEER 1 is a monotherapy trial while oral semaglutide is tested versus Tresiba in treatment naïve type 2 diabetes patients. The remaining PIONEER trials for oral semaglutide are all expected to report throughout 2018 followed by NDA submission next year. We additionally expect both LAI287 once weekly ultra-long acting basal insulin and G530 for obesity, the glucagon analog to complete their Phase 1 programs within the first quarter of 2018. Finally, in the first quarter, the regulatory submission of N8-GP in the EU and US is expected. And with this, I will hand over to Jesper for an update on the financials.

Thank you, Mads. Please turn to slide 16. In 2017, sales increased by 2% in local currencies and was unchanged in measured in Danish kroner. The gross margin was 84.2% measured in Danish kroner slightly lower than the level in 2016. The decline in gross margin reflects a negative currency impact of 0.3 percentage points. In addition, the gross margin was negatively impacted by lower realized prices in the US, which was offset by a positive contribution from product mix due to higher Victoza and Tresiba sales. Sales and distribution costs increased by 2% in local currencies and were unchanged in Danish kroner. This development reflects increased Salesforce and promotional cost in region AAMEO and region Latin America as well as increased cost related to legal cases. This was partly offset by reduced demand in the US and broad cost control initiatives. Research and development cost decreased by three percentage points in local currencies and by four percentage points in Danish Kroner. The decline represents [ph] a discontinuation of a number of research projects following the updated R&D strategy announced in October 2016, leading to lower research cost. Administration costs declined by 3% in local currencies and by 4% measured in Danish Kroner. The lower administrative costs are reflecting general cost control initiatives. Operating profit increased by 5% in local currencies and by 1% in Danish Kroner. Net financial items showed a loss of DKK 286 million compared with the loss of DKK 634 million in 2016. This development reflects a loss for the full year 2017 on foreign exchange sorry on foreign exchange forward contracts hedging the U.S. dollar and Chinese Yuan due to the interest differential versus the Danish Kroner. Diluted earnings per share increased to DKK 15 and DKK 39 corresponding to an increase of 3% measured in Danish Kroner. Please turn to Slide 17. The recent development in currencies impact Novo Nordisk's results reported in Danish Kroner for 2017. However in line with our treasury policies and more significant foreign exchange risks have been hedged primarily through foreign exchange forward contracts. Since mid-2017 we've seen a significant depreciation of the U.S. dollar versus the Euro on the Danish Kroner and most [indiscernible] currencies. As a consequence, reported operating profit in 2017 is negatively impacted by 4 percentage points. The currency impact for 2018 is reflected in our outlook for the year which I will turn to now. Please turn to Slide 18. For 2018, sales growth is expected to be in the range of 2% to 5% measured in local currencies. This reflects expectations for robust performance for the portfolio of new generation insulins and for the GLP-1 portfolio now comprising both Victoza and Ozempic as well a solid contribution from our obesity product Saxenda. Sales growth is expected to be public by intensifying global competition both within diabetes care in biopharmaceuticals especially within the hemophilia inhibitor segments as well as continued pricing pressure within diabetes care especially in the U.S. Given the significant depreciation for the U.S. dollar and related currencies versus the Danish Kroner reported sales growth is expected to be around 7 percentage points lower than the local currency level. Operating profit growth is expected to be in the range to 1% to 5% growth measured in local currencies. The expectations for operating profit growth reflects the outlook for sales as well as the planned increase in the sales and distribution cost to support the launch of Ozempic. Reported operating profit is expected to be 10 percentage points lower also reflecting the significant depreciation of the U.S. dollar and related currencies versus the Danish Kroner. We expect financial items to reflect a net income around DKK 2.5 billion. The current expectations reflect gains associated with foreign exchange, hedging contracts mainly related to the U.S. dollar and Japanese Yen versus the Danish Kroner partly offset by losses on non-hedged currencies. The effective tax rate for 2018 is expected to be in the range of 20% to 22% positively impacted by the reduced federal corporate tax rate in 2018 in the U.S. Capital expenditure is expected to be around DKK 9.5 billion in 2018. The investments are primarily driven by the construction of an active pharmaceutical ingredient production facility in Clayton, North Carolina. This ongoing investment is in total estimated to be around US$2 billion and is expected to be completed in 2020. Furthermore depreciation, amortization and impairment losses are expected to be DKK 3 billion. For 2018, we expect the free cash flow to be in the range between DKK 27 billion to DKK 32 billion. Please turn to the next slide. During the coming 12 months, we will be executing a new share repurchase program for 2018 of up to DKK 14 billion. The total program may be reduced in size, if significant product in-licensing or bolt on acquisition opportunities arise in 2018. Do also note that our majority shareholders Novo Holdings is a wholly owned subsidiary of the Novo Nordisk foundation has informed us that they intend to participate in the share repurchase program in 2018 and then they currently intend to maintain their share ownership at around 28% of Novo Nordisk capital. The purposed total dividends for 2017 increases by 3% to DKK 7.85 including the interim dividend of DKK 3 paid in August 2017. The total payout ratio of 50.4% is in line with our pharma peer group payout ratio of around 50%. So this concludes my 70 quarterly financial update to the market. Now back to you, Lars. Lars Fruergaard Jørgensen: Thank you, Jesper. What a performance? Please turn to Slide 20. I'm pleased that we delivered on our plans for 2017 and we are continuing to build a platform of sustainable growth, the approval of Ozempic in the U.S. was the combination of a year in which we achieved important product approvals and labor updates. In 2018, we will focus on the global launch of Ozempic and pursued the full value potential of our strong portfolio in what continues to be a competitive environment, we're now ready for the Q&A where I kindly ask all participant to limit themselves to two questions. Operator, we're now ready to take the first question.

Thank you. [Operator Instructions] We will now take our first question from Peter Verdult from Citi. Please go ahead, the line is open.

Thank you, Peter Verdult, Citi. Two questions, Jesper on your 70th quarterly call maybe you can talk a little bit about tax. Previous guidance on sensitivity to U.S. tax reforms suggested that the group tax rate would go down to around 20%, you are giving the range of 20, 22, just hoping you can discuss some of the offsetting factors that play and then secondly Lars I realized discussing potential price points for is little premature ahead of seeing the Phase III data but there is a healthy debate on this important topic that you place in the market. Some believing you could price at current thing versus GLP-1 price points. So it seems little inconsistent with the messaging you've given to date including the recent CMD, so wondering if you could clarify your thoughts on what is possible and what is not if the pioneer program delivers within the timeframe you expect, thank you. Lars Fruergaard Jørgensen: Jesper on tax?

Yes, thanks Peter. Well, the range we have given of 20 to 22 is indicating that we anticipate a bit over a percentage point in positive tax impact from the lower U.S. corporate tax rate. So that's pretty margin line with the 21.7 we have in 2017. So not really any significant changes, however too bear in mind that the gradual reduction of the overall share of our turnover that arises from the Biocon franchise have a tendency to up the average tax rate for Novo Nordisk and if you add those two components, you get very close to the mid-point of the range that we presented. Lars Fruergaard Jørgensen: Thank you, Jesper. And on price points for all segments I do understand that there is an interest in discussing this and understanding it bit better but as you say yourself we need to see the clinical data and also from a competitive point of view it's not really in our interest to be very specific on what price points we are growing with, we are taking long term view on this, we're trying to optimize the formulation and what we guided at there with GLP-1 like pricing and that's what we can say for now. Thank you very much, next question please?

Thank you. We will now take our next question from Vincent Meunier from Morgan Stanley. Please go ahead, your line is open.

Thank you, Vincent Meunier from Morgan Stanley. The first question is on the capital allocation, I mean can you talk about your M&A priorities after I believe and particularly in the context of Jesper taking the lead in biopharm and I'm wondering are you still looking for deals in the low single digit billion dollar range or would you consider bigger targets given your comment on the buyback, the second question is on the incidence, pricing environment. I mean your performance has been quite strong for the GLP-1 part of the business but incidence continues to be under pressure and it's now chronic. Do you think that it's coming to an end and if it's irreversible, would you consider a bigger restructuring of the U.S. insulin unit? Thank you. Lars Fruergaard Jørgensen: So, Jesper you should start on the capital allocation in the country.

Yes, thanks Vincent. In terms of our M&A priority, they are completely similar is what we have communicated the last 18 months or so, we have said also in connection with last year's buyback that in case we were doing significant M&A activities, we may look at the size of the repurchase program and the tax that is included now is exactly the same as that was a year ago. So the no change in policy, in terms of magnitude of the acquisitions, I actually thought that the happening was pretty much in line with the size we had indicated of the US$2 billion to US$3 billion, I think that is still a very good guidance, I think we need to justify in the things we bring in that we can add value to our shareholders before we start doing something of a different scale. I also note that the focus should not solely be on acquisitions, it should just as will also be on in-licensing opportunities where we see the risk and rewards with the current owner of the assets. So it will little bit be dependent on where is the actual target that we need, that we would like to supplement our biopharm pipeline with that will be determining whether it's going to be an actual acquisition or whether it's going to be an in-licensing activity with a much lower capital, initial capital requirements. Lars Fruergaard Jørgensen: Thank you, Jesper. And on insulin pricing we see this as a new market dynamics, so there will be a continued pressure on pricing is what we have baked in our guidance for '18 and also long term financial targets, I think it's too early to speculate well there is an end to it, we have seen that in the fast acting category that is the rebate problem at a point of time, I think the base dynamics is slightly different. Bear in mind that we see a very strong dynamics in the GLP-1 space, so from a mix point of view, we have lots and lots of weight in the GLP-1 space where we have higher price points and also less price pressure right now. So on that dimension, we say time to get lower exposure to insulin but we see this as for now a permanent change that will lead to continued price pressure. Thank you.

Thank you. We will now take our next question from Trung Huynh from Crédit Suisse. Please go ahead. Your line is open.

Hi, thanks for taking my question. I have one on the financial targets and another on insulin. So first on guidance. It doesn't look like there is much margin expansion here, you're going to conduct a big outcomes trial with Ozempic, you have the pioneer program ongoing, you have the rollout with Ozempic and DTC advertising for the year, can you perhaps talk about your views on the development of the gross margin, SG&A and R&D going forward and then a quick question on the insulin market in contrast to the strong growth you're seeing with GLPs, if you have a look at the insulin prescriptions it looks like growth has laid significantly in the U.S. Can you perhaps talk about the dynamics you're seeing here, you previously said insulin volume could grow 3% to 4% is that something you still believe? Thanks very much. Lars Fruergaard Jørgensen: Jesper a bit on the financial targets and guidance.

It is a correct observation that when we guide sales with 2% to 5% growth in local currencies and the operating profit growing 1% to 5% there is not a lot of expansion of the operating margins, so that's completely in line with what we also said when we updated our long-term financial targets. In terms of the specific guidance for 2018, I think it will be appropriate to ask cost to give that guidance is you will enjoy holding him accountable to those guidance points throughout 2018. So over to you guys. Lars Fruergaard Jørgensen: Thank you, Jesper. As you said, it's correct that there's not a lot of margin expansion and build into 2018 financial guidance. In reality, when you look at it then the midpoint for our operating profit growth in local currencies is slightly lower than our sales growth in local currencies, so there is a slight margin erosion built into our targets. That margin erosion will come primarily from two sources, one is linked to the launch of Ozempic in the U.S., so we're putting significant resources behind succeeding with there are a lot of the same thing and being one and then the other piece is when you look at other operating income we had and non-recurring income in the third quarter related to a licensing deal within a family in the third quarter of '17 which would not take place in 2018. So those are the two main factors driving down markets slightly in local currencies in 2018.

Thank you, Karsten. In terms of interim market dynamics and growth of course this is something that's impacted by launches new products etcetera but we still believe in market because in a neighborhood of 3% to 4% is realistic for the U.S. market, so we cannot be much more specific on that. Thank you and the next question please?

We will now take our next question from Michael Leuchten from UBS. Please go ahead. Your line is open.

Thank you very much. Michael Leuchten from UBS. Two questions please. one on the change in the CFO role obviously we're very sad to see yes because and I fully appreciate that cost is a very safe pair of hands to take over but in terms of timing I was wondering if you could comment on why now is a good time to make a change given that you do have the execution going on you have the change to U.S. structure and other things going on within the company. And then the second question is on the Ozempic launch could you please comment on your access plans/ launch plans and also how and when you plan to use to sustain seven trial in the launch given that access I believe will be limited in 2018 and also tied into you just previous comments about the investments you planning to put into put a franchise in 2018.

Yes, so in terms of timing of change I see if, I think we should all be in mind that since May last year yes but besides being the CFO also being involved in setting this strategy for biopharma area. We have a clear objective to return biopharma to grow and number the organizational upgrades priorities in terms of our existing portfolio and also the non-organic options we're looking at. And in parallel with this, yes it is as a very strong leader being very focused on developing talent in his own area and we have a very ready and capable successor, so looking at this yes but I felt that he could add even more value by focusing more on the biopharma business. And we feel that custom is a great beetle to lead the financial organization forward and so I see this as a continuation of how we managed our finances and I do acknowledge that yes there has been a very visible individual business investors and beating our financials with very safe hand. But I'm glare just we're still on the team and I feel very strongly that our finance organization is really to beat it under cost. Then in terms of Ozempic launch. I was in Chicago earlier this week to kick off the launch meeting with our U.S. team and I can tell you they are all fired up and we could hardly keep them in the room because they're so eager to get out in the field, so they'll be out on Monday pushing that the brand in the U.S. You are right that excess nowadays comes slower than we were used to or some payers actually block. Access from the get go until we have negotiate a contract and so we cannot expect the same uptick as we have expected when we for instance launched the tools even when to lose this to the market, so we have always secured the first contracts, so we can have the reps go out in detail and also drive sales in the U.S. market but we have the strong position that we can, we can keep already busy because they can either promote the total all Ozempic. So from a sales force productivity point of view they can all go out and win and be successful. And I think that's a significant morale boost in that part of the company and then we're gradually be switching focus for the Reps as we gain access throughout the year, so I think this can maintain a very strong momentum behind our GLP-1 performance and maintain a double digit growth and we believe we can achieve DKK 1 billion are more than that during 2018 in terms of driving Ozempic. And then to sustain seven I think Mads we have some good news in terms of ability to go out and talk to that.

Yes, well first of all the good news is that the 16, 7 came out in the Lancet Diabetes and Endocrinology journal online this morning or at last night relate with all the great data that I think you've heard about before and you can see them in great detail both on the efficacy and safety and tolerability side, so that's really good news and according to the freedom of speech and so on X in the U.S. you are aware that our liaison medical I sounds are obvious be able to use these reprints in a good way. I think this is together with the 53A sustain 126 program and very important data sets forward the charts of physicians for future administration or installation of GLP-1 products.

Good, thank you Mads. Thank you, Michael. Next question please?

We will now take our next question from Michael Novod from Nordea. Please go ahead. Your line is open.

Yes, hello it's Michael Novod from Nordea Copenhagen. So one question has been made has gotten today around the year the prior period adjustments. I don't know whether you could perhaps try to detail that a bit more on a product level in a kroner perspective for Q4 just to get some kind of clarity for traction in the quarter and in the U.S. And in the same question perhaps also talk a bit about the say changes in emerging markets whether they any say moves from one quarter to the other and then secondly looking at the Tresiba and the Medicare Part D both Tresiba and Levemir. So, do you start to see the benefits coming from the exclusion of Santa Fe out of the CVS Medicare Part D it seems like it perhaps is basically that gains a bit more traction from this and then you guys. Thanks a lot. Lars Fruergaard Jørgensen: Thank you, Michael so if you take the tenders in emerging markets first maybe Mike, can you could give few comments on. A lot of getting maybe in two more details played out.

So though there is the product we get into details is when you're thinking about tenders then primarily you're looking at human insulin and the hemophilia both on factor eight and factor seven and any given point of time of course depending on the various different governments and geography needs then there could be some movements. Most of those movements are preplanned, however and in very close dialogue with the various governments and we have seen some of that also in 2017 and '18 as usual I cannot get into more details of that.

Thanks, Mike. In terms of your prior period at Michael it is a little bit prostrating that we in the period gets a significant adjustment, however it is a particular propound this fourth quarter for our Novo lock, Novo rapid franchise in the U.S. and that's really relating to that the channel flow has in the subsequent report we got after our 1 of November announcement basically indicated have documented that a higher proportion is flowing through lower or higher rebate ten I lowered value channel to us. That creates a total full year adjustment for that patent flow of 500 million which have been adjusted in Q4 but it is as I said is related to the full year 2017. Likewise for Tresiba there's approximately 200 million in a adjust to rebate booked in the fourth quarter relating to full year 2017 and on the other hand we have been benefiting from a better channel flow probably told 100 million in opposite direction. So when you need those two out, it is really the 500 million in Novo lock which is the big movement in Q4 and it should not be looked at in Q4 alone it should be look as an adjustment to sales for 2017. So overall I do believe that they full year numbers are giving an accurate and true feature of our sales force in the U.S. However if you put a loan is hard to predict or hard to start.

We got to the Part D opportunities were see has exceeded benefit raise. It's too early for us to be strategic concentration but it looks promising probably see the dynamics will be fixed different as you're based 100 into similar molecule we were converting to another Part D. We believe that they will have the fair this is too early to specific on how much we are hedging.

Okay, thank you.

Thank you.

Thank you very much. Lars Fruergaard Jørgensen: There, I think there is a bit of noise in the background.

Thank you. Next question please.

We will now take our next question from Simon Baker from Exane. Please go ahead. Your line is open.

Thank you for taking my questions. Firstly just going back to Michael's question on Ozempic access I want to if you could give us an idea of the current covered lives for Ozempic and the opportunity for 2018 clearly a lot of plans particularly within Part D will be a 2019 access event and I just want to if give you an idea how much you can capture of the markets in 2018 in this year rather than waiting to 2019. And then secondly going back to the guidance and the commentary on the FX impacts on operating profit it seems that both in 2017 and implied to the 2018 guidance though is I think because of what you said yes so on in terms of the interest rate differentials. The hedge appears to be less effective when one considers the hedging gains versus the kroner impact on operating profit. I wonder, if you could give us a little bit of color on the if you like the true hedging gains for 2017 and how we should think about 2018 and trying to chip bridge between the guidance of around to DKK 2.5 billion of net financials and the implied Kroner impact that 10 percentage points suggests. Thanks so much.

Okay, thank you, Simon I'll start on Ozempic access, so it's important for us to make sure that all peers they have a good understanding of the clinical profile. We don't want to rush access where we jeopardize appreciation of what the product can do, so we will be patient in terms of making sure that the pool in the market and on center of the profile is getting for excess. We're not going to give you a data on where we are actually throughout the year. But as I mentioned before we have secured the first contracts and the Reps will in a number of states be able to go out and sell Ozempic, so I think that's encouraging and that's based on ensure understanding the profile of the product and having a clear preference for having that on commentary.

And then in terms of currency impact on operating profit I think my first comment would be that the significant negative currency impact that we've had in 2017 is actually more or less alone arisen in the final quarter, so the impact in the final quarter is an impact to the tune of DKK 1.3 billion taking it to a total clear impact on operating profit of DKK 1.8 billion. And that's of course coming not only, you could say roughly half of that is coming from the U.S. dollar but also a substantial impact from the CNY, so the Chinese Yuan and the Japanese Yen. Then if you look to hedging for 2017, we do capture out of the impact in the U.S. we capture just below half in terms of hedging, so again up to the 200 million to 300 million. The problem we have on the hedging the U.S. dollar is this interest differential and then actually get even worse when we look at the CNY because we we're hedging that that in CNH, so an offshore Yuan with a higher interest level and then when the movement is not big enough you get actually a loss both on the hedging and on the operating profit, so I'd say it's almost as big the impact on our net profits from the movements of the CNY and the hedging of the CNY, and that's also why we have decided, and there was actually Karsten and I in conjunction that agreed that we moved our CNY hedging down to half of them now only being hedged on the six month horizon instead of 12 months because of this deficiency in the hedging cost, but it has been a little bit painful. Most of the, you could say the Japanese yen with a low interest environment has been completely effective and a very little loss on net profit from hedging the Japanese yen. So that really works. So, the rest that is significant on operating profit is really the Argentinean peso, the Turkish Lira, and the Iranian whatever is called real. That's been the main currencies impacting our operating profit. Karsten in terms of the outlook for 2018 and our hedging against that, maybe a few comments from your side.

Yeah. So in relative, it's the same mechanism as we just described for 2017, just of a bigger magnitude. So the 10% negative currency impact on operating profit corresponds to the DKK 5 billion negative impact. The way we hedged our net currency exposure to the extent of around 80%. So we apply hedging to this 80% or some DKK 4 billion. And it's basically those DKK 4 billion, you should compare our hedging gains of some DKK 2.7 billion on and that’s spread between the 4 billion and the 2.7 billion. That is a reflection of primarily the interest rate differential between the US dollar, the US zone and the Eurozone and then to a slight extent the fact that we’re only hedging CNY through CNX on a six month horizon. So those are the two main factors explaining. The remaining part of the negative currency impact on operating profit hinges on non-hedge currency sale, which again as Jesper said, Argentinian peso, et cetera.

We will now take our next question from Richard Vosser from JPMorgan.

Just going back to the impacts on the rebate adjustments throughout the year and just thinking into 2018, so you’ve had a better mix for Victoza, so should we think that that mix would continue to be some of the more commercial higher priced patients rather than Medicare patients or as you grow -- restart growing in Victoza, could we expect the channel to go the other way. And then just so Tresiba, as was related to that the Part D contracts I think would take the mix negatively again in 2018, so just some thoughts on pricing mix in Tresiba in 2018 would be useful. And then finally just on PIONEER 3 and 4. They seem to have moved earlier in the year since the Capital Markets Day. So they're now on in Q2 rather than Q3. So just thoughts of the reasons for this and when also should we expect the PIONEER 1 data?

So, it is correct Richard that PIONEER 3 and 4, which is a superiority versus trial and the matching Victoza 1.8 milligram trial respectively, they are now destined to be made available in the form of meetings just before the end of the second quarter. So it’s a minor change that pushes it forward, because we’re interested in having as much data as fast as possible and we of course know when the last patient entered and hence also leaves the clinic again. And with regard to PIONEER 1, which is the first report, it is somewhere between now and the end of the first quarter. That's as much as we can say, but we will keep you alert because even though it's a placebo controlled trial in treatment naïve patients, it is of course an important one because it will hopefully confirm what we all of us think namely that we have a drug that really works also in bigger populations and then you can compare those data to what has been seen for Victoza and other GLP1s in such a population.

Thanks, Mads. And then in relation to the channel mix for Victoza, I think the full year numbers for 2017 is a fair reflection of the channel mix we've had and the average price that we’ve obtained for Victoza. However, I do note that as we gradually expand Victoza, the mix is of course gradually getting into lower price channels as so if we do compare ’17 up against ’16, it is slightly lower product channels for Victoza and a gradual continuation, although not significant movement should be expected for ’18. For Tresiba, I think you rightly point to that a gradual higher proportion of the Tresiba volume will go through Medicare Part D and as a consequence of that, a gradual erosion of the average prices realized. I think that is completely customary in terms of the gradual penetration of a product into the market and we are quite satisfied with the Part D coverage we have for Tresiba.

We will now take our next question from Alex Arfaei from BMO Capital Markets.

First regarding the large cardiovascular study with Ozempic, I'm wondering if you could provide more color on your strategic thinking there. Obviously, this is a big expensive study. You already have some cardiovascular data in your label. Is this because you're worried about the upcoming dulaglutide data will be more compelling than what you have. And then second on the market, as you look at the competitive landscape, how many biosimilars do you see in major markets, both for basal insulin as well as that. Thank you.

Yeah. And of course, the two of those. So the rationale behind each of them is as follows. The SOUL trial is the superiority trial in people with diabetes and established CV or kidney disease and this is basically a trial to -- once and for all get the superior nature on MACE events of semaglutide, also versus what we've seen for other compounds such as liraglutide. This is really significant and something that should enter into all the treatment guidelines and being top of mind of the physicians. We’re including a number of endpoints, including cardiovascular mortality, all-cause mortality, onset of nephropathy, worsening of nephropathy, health economic outcome, research endpoints, patient-reported outcome questionnaires and a number of things that create value to what treatment guidelines providers and a number of other folks. The other trial, the SELECT trial is even bigger and do bear in mind that the cost is actually expensed over many, many years. So even though the per se are costly, then noticed contact them with our own Clinical Research Associates, which are about half price of those that you can get from CRO companies because there is no markup. But the other trial which is done in 17,000 patients, we consider a landmark study in that, it will be the first time ever we hope to prove that obesity is a serious medical condition where we can actually with the pharmaco-therapeutic intervention actually provide better outcomes in terms of life expectancy and life quality vis-a-vis avoiding stroke and myocardial infarctions. This we can also help economically then justified will enhance the societal productivity and improve the reimbursement status for this devastating disease in many countries of the world that today consider it more of a lifestyle driven disease and obviously it also will help prove that semaglutide has mechanisms that are cardio protected but are totally regardless of the glycemic status of the patient. Lars Fruergaard Jørgensen: In terms of biosimilar incidence, we do not really comment on how many will make it to market and what the success of them will be. I’ll just make a note that already in the both fast acting and the basal categories today, there is enough products to really play out into quite tough competitive dynamic where payers have choice and that leads to price competition. So it's not certain that more biosimilars will change the dynamics significantly.

We will now take our last question from Wimal Kapadia from Bernstein.

Two please. So at the start of the year, we saw less price rises within the basal insulins of mid-single digit and I think this is the first time since 2015 that we've seen list price rises in the US. So could you just give us any comments as to what has changed in the market to give you comfort in raising list prices within the basal market? And then secondly on oral sema, there's been lots of discussion around the dosing protocol with respect to the food and water and the GI tolerability of the product. What I wanted to know was maybe this one is for Mads, how do you think about the impact on compliance of the product. I mean, if you read the literature, it seems like compliance to be injectables is lower than orals, which makes sense given that the injectable and you also have the GI side effects, but how do you think about the compliance of the oral sema product versus the existing orals in the longer term given that the product profile and the fact that diabetes patients tend not to follow instructions very well?

So on list price increases, I cannot go into committing a lot on our strategy here because for competitive reasons, but we felt it was prudent to take a small list price increase in the US well below what we've seen historically. So, I cannot really comment on what we intend to do in the future. Mads?

Yeah. And so here are two situations to consider, that’s the adherence of the therapy in a controlled setting such as a Phase 3 PIONEER trial and that's the real world situation once we are out in the marketplace and vis-à-vis the first of the two, we know from the Phase 2 trial where 500 plus patients showed absolutely no signs of not adhering, i.e., there was super imposability between the expected dosing and exposure whether it was by the oral route or by the injection route. And since the guidance we're giving the physicians and patients is even simpler and clearer in phase 3 and we are following up, I would not expect to see any adherence problems in that study and if so it would be very, very few patients relatively speaking. Now in the real world setting, I would agree with you because I know from many persons, but also market research related activities that adherence to injection based therapy tends to go down, because people find excuses for why they, on a particular day or particular occasion, don't need to inject themselves. This is not the case when you get the habit of taking a once-daily tablet like a vitamin or something, you tend to take that very seriously and on an ongoing basis. So I would expect that the real world adherence for oral sema would be even better than for instance to a daily injection based on everything I know. Lars Fruergaard Jørgensen: Thank you, Mads and thank you all for dialing in and listening to us. This concludes our conference call. Thank you for participating and feel free to contact our Investor Relations to ask further questions you might have and then we also look forward to meet you in the coming days on the roadshow. Thank you and have a good day.

Thank you. Ladies and gentlemen, that will conclude today's conference call and you may now all disconnect.