Novo Nordisk A/S (NVO) Q4 2013 Earnings Report, Transcript and Summary

Good day, and welcome to the Q4 2013 Novo Nordisk A/S Earnings Conference Call, hosted by CEO Lars Rebien Sørensen. Today's call is being recorded. At this time, I would like to turn the conference over to Lars Rebien Sørensen. Please go ahead, sir. Lars Rebien Sørensen: Thank you very much, and welcome to Novo Nordisk conference call regarding our performance in 2013 and the outlook for 2014. I'm Lars Rebien Sørensen, the CEO of Novo Nordisk. With me, I have our Chief Financial Officer, Jesper Brandgaard; and, of course, Mads Thomsen, our Chief Science Officer; and present are also our Investor Relations officers. Today's earnings release and the slides that we'll be using for the call are available on our web page. Conference call is scheduled to last approximately 1 hour. As usual, we'll start with the presentation as outlined on Slide #2. The Q&A will begin in about 25 minutes. Turn to Slide #3. As always, I need to advise you that this call will contain forward-looking statements. Those forward-looking statements are subject to risks and uncertainties that could cause the actual results to differ materially from expectations. For further information on the risk factors, see the earnings release and the slides prepared for this presentation. Please note that the conference is being webcast live, and a replay will be made available on our website. Turn to Slide #4. We're pleased with the robust sales growth in 2013. Sales increased 12% in local currencies and 7% in Danish kroner compared to 2012. Sales growth was driven by North America, International Operations and Region China. Sales growth was realized both within diabetes care and biopharmaceuticals, with a majority of the growth coming from modern insulins and Victoza. The rollout of Tresiba, the once-daily, new-generation insulin with an ultra-long duration of action, continues to progress with encouraging performance in countries where market access is on par with insulin glargine. On the R&D front, we recently filed liraglutide 3 milligram for regulatory approval as treatment for obesity in America and in the EU. To further strengthen the profile of Tresiba, Novo Nordisk has initiated 2 64-weeks randomized double-blinded crossover trials to assess the hypoglycemia benefits of Tresiba compared to insulin glargine and to patients with type 1 and type 2 diabetes. Our late-stage diabetes pipeline is further progressing. We now initiated the first Phase IIIa trial for LATIN, that is liraglutide as adjunct therapy to insulin in type 1 patients. Moreover, further Phase IIIa trials have been initiated with semaglutide and faster-acting insulin aspart. On the biopharm R&D side, NovoEight, now being launched in the first markets in Europe and has also been approved in Japan. Turning to the financials. Operating profit grew 15% in local currencies. As reported, our operating profit grew 7%, reflecting the negative impact from key invoicing currencies, and diluted earnings per share grew 20%. For 2014, we expect sales growth measured in local currencies to be between 8% and 11%, whereas operating profit growth, as measured in local currencies, is expected to be around 10%. At the Annual General Meeting in March, the Board of Directors will propose a 25% increase in dividend to DKK 4.50 per share of DKK 0.20 Euro [ph]. Lastly, an announcement on an organizational change in executive management. After -- effective 30 January this year, Chief Operating Officer Kåre Schultz is appointed President and Chief Operating Officer. The promotional is a reflection of the importance and the complexity of Kåre Schultz' organization, which is called Operations, which he has led successfully since 2002. Operations is responsible for Novo Nordisk global sales and product supply organization. In his role as President, Kåre will work closely with me and other members of executive management on matters relevant to the Board's senior leadership and the Board of Directors. Turn to Slide #5. 2013, North America accounts for 66% of growth, followed by International Operations accounting for 20% of growth in local currencies. Sales in North America was 18% -- sales growth in America was 18% in local currencies, reflecting a continued positive contribution of pricing in the U.S., solid market penetration of all our 3 modern insulins, in particular Levemir. Despite increased competition, Victoza continues to increase its market share leadership in the U.S. GLP-1 market during 2013. Sales in International Operations grew 17% in local currencies, reflecting robust penetration of all the 3 modern insulins and a continued strong performance of the biopharm business. Sales growth of Victoza also contributed and was primarily driven by a number of Middle Eastern countries, Brazil and Argentina. Sales in Region China increased 13% in local currencies. The growth was driven by all the modern insulins, while sales of human insulin only grew modestly. The performance in Europe and Japan continues to reflect challenging operating environment, stagnating volume growth in the insulin market. Turn to Slide #6. In the year 2013, both the diabetes care and the biopharmaceutical franchise grew 12% measured in local currencies, and both businesses thereby continued to exceed robust growth. Within diabetes care, modern insulins were the primary growth drivers, accounting for 54% of the growth, followed by Victoza accounting for 28% of the growth in local currencies. Sales growth within diabetes care was partly countered by declining OAD sales as a result of the rapid generic erosion of branded sales in the U.S. Growth in biopharmaceuticals reflects continued solid performance of Norditropin and NovoSeven, driving 10% and 7% of the total sales growth, respectively. Turn to Slide #7. Sales of modern insulin has increased 14% in local currencies and 10% in Danish kroner to DKK 38.2 billion. Sales growth was driven by all 3 modern insulins, Levemir, NovoRapid and NovoMix, growing 22%, 12% and 10% in local currencies, respectively. North America accounted for 2/3 of the growth, followed by International Operations and China. Sales of modern insulins now constitute 78% of Novo Nordisk's sales of insulin. Turn to Slide #8. Sales of Victoza reached DKK 11.6 billion in 2013, reflecting robust performance in North America, Europe and International Operations. Victoza holds a global market share of 71% of the GLP-1 segment in value compared to 68% the year before. The GLP-1 segment value share of the total diabetes care market has increased to 6.9% compared to 5.9% the year before. In the U.S., the largest market for Victoza continues to drive the expansion of the U.S. GLP-1 market and now accounts for 67% of GLP-1 market value in the U.S. despite increasing competition. Turn to the next slide for an update on the Tresiba rollout. The rollout of Tresiba continues to progress. Launch activities are proceeding as planned and feedback from patients and prescribers are encouraging. Tresiba is now commercially launched in 8 countries, with 20 more countries expected to launch during 2014. In the countries where Tresiba is reimbursed on a similar level as insulin glargine, it has steadily grown its share of the basal insulin market. In these countries, Tresiba now represents around 10% of the basal insulin market measured in monthly value market share. In markets where Tresiba has been launched with restricted market access compared to insulin glargine, such as in the U.K. and Denmark, market penetration remains modest. Now to Mads for an update on research and development.

Thank you, Lars. Please turn to Slide 10. Starting with Tresiba for which the DEVOTE cardiovascular outcome trial is progressing well, we've now also initiated 2 64-week randomized double-blind crossover trials comparing the safety and efficacy of Tresiba versus insulin glargine. The overall purpose of the trials is to further substantiate the hypoglycemia profile in types 1 and 2 diabetes when compared in the blind assessing to insulin glargine. In one of the trials called BEGIN-SWITCH 1, 450 subjects with type 1 diabetes will be sequentially treated with Tresiba and insulin glargine, in combination with insulin aspart in a randomized order. In the other trial, BEGIN-SWITCH 2, 670 type 2 diabetics will be treated sequentially with Tresiba and insulin glargine, on top of metformin and, likewise, in a randomized order. Please turn to the next slide. As announced in December of last year, we filed liraglutide 3 milligram for obesity treatment with the FDA and the EMA. Liraglutide 3 milligrams is intended for use as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults with obesity or those who are overweight and have comorbidities. We have recently completed the DUAL IV type 2 diabetes Phase IIIb trial for IDegLira. In Q4, 435 type 2 diabetic patients, inadequately controlled on sulfonylurea alone, or in combination with metformin, were randomized to 26 weeks of treatment with either IDegLira or placebo added to their existing oral anti-diabetic therapy. From a baseline HbA1c of 7.9%, people randomized to IDegLira achieved a statistically significantly greater average reduction in HbA1c of 1.4% compared to 0.5% for those treated with placebo. Close to 80% of the people using IDegLira achieved HbA1c ADA treatment target of below 7% compared to just below 30% of those in the placebo group. No apparent differences between IDegLira and placebo were observed with respect to adverse events and standard safety parameters. For semaglutide, we, late last year, completed recruitment to the SUSTAIN 6 cardiovascular safety trial that is performed in more than 3,000 type 2 diabetic patients with increased cardiovascular risk. Furthermore, we've initiated 2 additional trials in the SUSTAIN program. These trials compare semaglutide as add-on to existing oral anti-diabetic drugs for 56 weeks to either a once-weekly exenatide or sitagliptin comparator, respectively. We expect to initiate 3 more trials in the SUSTAIN program during this year. In November 2013, we initiated a 6-week pump trial evaluating the compatibility and safety of faster-acting insulin aspart and regular insulin aspart. The trial is expected to include 40 people with type 1 diabetes. With this, all 4 trials in the Phase IIIa onset program are now ongoing. For liraglutide, we have now initiated the first Phase IIIa trial, ADJUNCT ONE, investigating liraglutide as an adjunct therapy to insulin in people with type 1 diabetes. ADJUNCT ONE is expected to include 1,400 type 1 diabetics for 52 weeks with either liraglutide or placebo, both as a supplement to insulin intensification. We expect to initiate the second Phase IIIa trial, ADJUNCT TWO, in the first half of this year. Furthermore, we've initiated the first-ever Phase II trial with an oral GLP-1 analog. This trial will investigate semaglutide tablets administered once-daily compared to placebo over a 26-week period in 600 people with type 2 diabetes. Lastly, within diabetes, the U.S. FDA has approved the prefilled FlexTouch ortho injection pen for use with NovoLog and Levemir. FlexTouch is expected to be launched in the U.S. in the second half of 2014. Please turn to the next slide for an update on biopharmaceuticals development. Following European approval in November 2013, Germany was the first country to launch NovoEight this month, NovoEight being the new recombinant coagulation Factor VIII product for the treatment and prophylaxis of bleeding in patients with hemophilia A. Furthermore, NovoEight was approved in Japan this month, and we now expect to launch NovoEight in a number of European countries and Japan during the course of this year. In December 2013, the U.S. FDA approved Tretten, the recombinant factor XIII A-subunit product marketed under the brand names NovoThirteen outside of North America. Tretten is approved for the routine prophylaxis of bleeding in people with congenital types of XIII A-subunit deficiency, for which indication, it is the only recombinant treatment. Around 1,000 people globally are diagnosed with this rare disease. Tretten is expected to be available in the U.S. early this year. In January, we completed paradigm 3, the second Phase IIIa trial, with N9-GP, our long-acting GlycoPEGylated recombinant factor IX product for people with hemophilia B. Paradigm 3 evaluated N9-GP during surgical procedures in 13 people with hemophilia B consistent with the regulatory guidelines. With a success rate of 100%, a single preoperative dose of 80 units per kilogram of N9-GP prevented bleeding in all patients during major surgery. And factor IX activity level was maintained in the normal range throughout the surgical procedures, and no additional dosing was required during the course of the patient surgery. In addition, the effective post-operative hemostatic coverage was achieved by a median of 2 40 unit per kilogram doses of N9-GP during the first 6 days after surgery. N9-GP appear to have a safe and well-tolerated profile and inhibitor formation was not observed. A multiple-dose trial investigating the once-weekly growth hormone derivative, NN8640, in adults with growth hormone deficiency has also been completed. NN8640 appears to have a safe and well-tolerated profile and no safety constraints were identified. The trial confirmed data from a similar trial in healthy adults, and in a clear dose-dependent manner NN8640 increased circulating IGF-1 levels 2 or above the normal range, supporting once-weekly administration in adults with growth hormone deficiency. Based on this, we expect to make a Phase III stop-go decision for the adult growth hormone deficiency indication for NN8640 around midyear. In December 2012, we communicated the discontinuation of further development of anti-NKG2D as a treatment for Crohn's disease based on the results from a futility analysis. Following completion of the trial and analysis of the full data set, we've now decided to reinitiate development. Thus, and albeit the primary endpoint at week 4 was not achieved, the analysis demonstrated a clear biological and clinical effect of a single dose of anti-NKG2D at week 12. Anti-NKG2D furthermore appeared to be safe and have a well-tolerated profile. Based on this, we'll now continue the development of anti-NKG2D for Crohn's disease, with additional Phase II trials. Finally, we've completed a Phase IIa trial evaluating the monoclonal anti-IL-21 antibody as a treatment for rheumatoid arthritis. In the trial, the primary endpoint of demonstrating a statistically significant change in disease activity compared to placebo was achieved. However, the magnitude of the treatment effect does not warrant further development of anti-IL-21 for RA at this point in time. Anti-IL-21 appear to have a safe and well-tolerated profile, and we'll continue to develop the compound for Crohn's disease and systemic lupus erythematosus. With that, over to you, Jesper, for the financials.

Thank you, Mads. Please turn to Slide 13. In 2013, sales increased by 12% in local currencies and by 7% measured in Danish kroner to DKK 83.6 billion. Reported gross margin improved by 40 basis points to 83.1% in 2013, primarily driven by favorable price development in North America and a positive net impact from product mix due to increased sales of modern insulins and Victoza. The gross margin was negatively impacted by around 0.3 percentage points due to the depreciation of key invoicing currencies versus the Danish kroner compared to the prevailing rates in 2012. Total non-production costs increased by 11% in local currencies and by 8% measured in Danish kroner. S&D costs increased by 13% in local currencies and by 9% in Danish kroner to DKK 23.4 billion. The growth in costs was driven by the expansion of sales forces and sales and marketing investments in the U.S., in China and in selected countries in International Operations, as well as costs related to the launch of Tresiba in both Europe and Japan. The growth percentage for costs is furthermore impacted by nonrecurring changes to legal provisions in 2012 and '13, adding some 3 percentage point to the S&D cost growth. R&D costs increased by 9% in local currencies and by 8% in Danish kroner to DKK 11.7 billion. Within diabetes care, costs are primarily driven by development costs related to the initiation of the Tresiba cardiovascular outcome study DEVOTE, the ongoing Phase IIIa trial for faster-acting insulin aspart and semaglutide, the once-weekly GLP-1 analog. Within biopharmaceuticals, costs are primarily related to the continued progress of the portfolio of development products within hemophilia and the Phase II trial for anti-IL-20 in rheumatoid arthritis. Operating profit increased by 7% in Danish kroner to DKK 31.5 billion. In local currencies, the growth was 15%, which is in line with the latest guidance for operating profit growth measured in local currencies for 2013 of 12% to 15%. Net financial showed a gain of more than DKK 1 billion in 2013 compared to an expense of around DKK 1.7 billion in 2012. In line with Novo Nordisk's treasury policy, the most significant foreign exchange risk for the group have been hit primarily through foreign exchange forward contracts. The foreign exchange result was a net income of DKK 1.1 billion compared to an expense of DKK 1.5 billion in 2012. This development reflects gains on foreign exchange hedging, involving especially the Japanese yen and the U.S. dollar due to their depreciation versus the Danish kroner, compared to the prevailing exchange rate in 2012. This positive effect is partly offset by losses on commercial balances, primarily related to non-hedged emerging market currencies. The effective tax rate for 2013 was 22.6%, which is in line with the latest guidance of a tax rate of around 23% for the full year 2013. Please turn to Slide 14. The negative impact from currencies and operating profit during 2013 was primarily driven by the depreciation of the Japanese yen, which in 2013, on average, was 21% below the average rate during 2012. In the first week of -- in the first weeks of 2014, we have experienced further significant volatility in both hedged and non-hedged currency exchange rate. In the 2 weeks leading up to the January 27, 2014, where exchange rates for the 2014 outlook were locked, we have seen the U.S.-Danish kroner exchange rate depreciating by 0.5%. In the same period, key non-hedged currencies such as Russian ruble, the Argentinian peso, the Turkish lira, the Indian rupee and the Brazilian real have depreciated with between 1.5 percentage points and up to 18% versus the Danish kroner. This decline alone has had a negative impact on reported operating profit outlook for 2014 of approximately 1 percentage point. Please turn to Slide 15. In 2014, we expect sales growth to be 8% to 11%, measured in local currencies. Given the current level of exchange rate versus Danish kroner, the reported sales growth is expected to be around 3.5 percentage point lower than the growth measured in local currencies. The sales outlook in local currencies reflect the expectations for continued robust performance for the portfolio of modern insulins and Victoza, as well as a modest sales contribution from our ultra-long acting insulin Tresiba. These sales drivers are expected to be partly countered by an impact from a more challenging contract environment in the U.S., generic competition to branded in the U.S. during the first half of 2014, intensifying competition within both diabetes and biopharmaceuticals, as well as the general macroeconomic conditions in a number of markets in International Operations. In 2013, operating profit growth is expected to be around 10%, measured in local currencies. Given the current level of exchange rate versus the Danish kroner, the reported operating profit growth is expected to be 5.5 percentage point lower than the growth measured in local currencies. The development in operating profit reflects a significant increase in cost related to the continued progress of key development projects within both diabetes and biopharmaceuticals. In addition, significant costs are expected in relation to the effect from sales force expansions and sales and marketing investments in the portfolio of modern insulins and Victoza in the U.S., China and selected market in International Operations, as well as an effect from the continued rollout of Tresiba outside the U.S. For 2014, we expect a net financial income of around DKK 750 million. This primarily reflect gains associated with foreign exchange hedging contracts following the depreciation of Japanese yen and U.S. dollar versus the Danish kroner compared to the average exchange rate in 2013. The effective tax rate for 2014 is expected to be around 22%. Capital expenditure is expected to be around DKK 4 billion in 2014, primarily related to investments in additional GLP-1 manufacturing capacity, expansion of billing capacity, prefilled device put option facilities, construction of new laboratory facilities, as well as expansion of CMC and protein capacity. Depreciation, amortization and impairment losses are expected to be around DKK 2.9 billion. Free cash flow for 2014 is expected to be around DKK 26 billion. All of the above expectation are based on the assumption that the global economic environment will not significantly change business conditions for Novo Nordisk during 2014, and that currency exchange rate, especially for the U.S. dollar, will remain at the current level versus the Danish kroner. Please turn to the next slide. At the Annual General Meeting on the 20th of March 2014, the Board of Directors will propose a 25% increase in dividend to DKK 4.50 per share of DKK 0.20 corresponding to a payout ratio of 47.1%. For 2012, the payout ratio was 45.3%. No dividend will be paid on the company's holding of treasury shares. The Board of Directors has approved a new share repurchase program of up to DKK 15 billion to be executed during the coming 12 months. As part of the up to DKK 15 billion share repurchase program, a new share repurchase program has now been initiated in accordance with the provisions of the safe harbor regulation. This concludes the financial update. Now back to you, Lars. Lars Rebien Sørensen: Thank you very much, Jesper, and also to Mads. To summarize, we are pleased with Novo Nordisk's performance in 2013, a year that also posed some challenges for us. The double-digit sales growth was, again, in 2013, driven by the robust growth of our portfolio of modern insulins and Victoza. For Tresiba, the Complete Response Letter in the U.S. was a disappointment, but in markets where we've launched, the product performance has been encouraging. We're now ready to take the question and answers. [Operator Instructions] Operator, we're now ready to take the first question.

[Operator Instructions] We'll take our first question from Michael Novod of Nordea Bank.

It's Michael Novod from Nordea in Denmark. Just 2 questions. First of all, to the GLP-1 market, we have seen a very good rebound from Q3. Could you say if you decompose, how much is actually due to the marketing boost or due to the genuine demand in the market? Because we have also seen that DEVOTE has not really rebounded, so there's this tracking development. So a comment on that would be appreciated. And then secondly, regarding Tresiba, Mads said that the enrollment progress is doing fine. Can you try to update us on how well are you enrolling right now? What is the timeline to complete enrollment? And hence, are you also on-track to potentially deliver data in Q4 '15 now when you have seen the first 3, 4 months of enrollment taking place? Lars Rebien Sørensen: And I will ask Mads to start out by commenting on the timelines, how things are going with DEVOTE and what the timelines we have for a readout, and so also, of course, a potential launch in the U.S.

Well, Michael, it's still early days. But what I can say is that we are off to a good start, so to speak. And to date, we are recruiting not only in the United States but also in the first European territories. You asked about the Q4 '15 as a potential interim analysis quarter. That is, actually, you can argue within the 2- to 3-year guidance that we've given, because we did initiate in October of last year. So that would be a possibility on the good side, but we are sticking to the guidance that is 2 to 3 years. But we will, as the year progresses, be able to be more specific, but we can say that we are encouraged by the progress at this point. Lars Rebien Sørensen: Thank you very much Mads. Yes, Michael, GLP-1 market in the U.S., we agree with you. We were quite happy about the development we saw. I saw a bit like the hot and the cold water mix, whether it's general -- our marketing boost that resulted in this, sort of general market development. I think in general, we could say that when we look at the second half of 2013, we believe that we saw a rebound due to the waning negative impact from the publicity around pancreatic cancer, which was created in the first half, following the relatively strong statements presented by scientific institutions and agencies, both in the U.S. and in Europe. So our expectations going forward is that the general market will continue, and Novo Nordisk will add another DKK 150 million per quarter. We have yet to see the impact from the ESI contract. We are starting to see week-by-week impact on the NBRx, which one would expect in such a situation. How large it is and whether that is comparable to our own planning, it's a little bit premature to say. We believe we need to have a few more weeks, if not 1 month or 2. So you will get a much, much better fix on this when we are back to you with the first quarter result. Sorry for that a little bit broad but a not very specific answer but this is how we see it. Thanks

The next question comes from Michael Leuchten of Barclays.

Just going back to the ESI comments. Do you stand by your guidance that for 2014, you expect the contract changes to remove about 1% in terms of growth, given the trends you're seeing? And has the gross-to-net ratio changed significantly in 2013? And then a question for Mads. The recruitment in the SUSTAIN 6 trial, does that tell you anything in terms of the implications for patient preference once-weekly over once-daily? Or is it -- is that impossible to read from that? Lars Rebien Sørensen: Thank you very much. Lars Rebien here. I'll just comment on ESI, and then Jesper will tell you a little bit about gross-to-net ratio in 2013, and then we'll have Mads at the tail end. Yes, we, at this point, I see no reason to change the guidance we gave when it was originally made public that we lost the ESI contract. We're talking about approximately a headwind of 1% of group sales, 2.5% of U.S.-based sales, and this is what, we, of course, like to be able to give you an update on in connection with Q1 when we have a little bit more fix on the trending. But we do see impact from NBRx on both the insulin side to Lilly, and on the GLP-1 side to AstraZeneca. And Jesper, gross-to-net development.

Yes, of course, the key development in gross-to-net for Novo Nordisk is the development in the North American sales and where we typically have seen a deduction in the ballpark of 26%, 27% of the gross sales being deducted. And I would say this year, the general rebating level in the U.S. has increased that deduction by approximately 1 percentage point. You'll find more details about the gross-to-net reconciliation in the annual report to be issued quite shortly. But assume approximately 1% overall increase in the gross-to-net reduction effect for the year. Lars Rebien Sørensen: Thank you very much, Jesper. SUSTAIN 6, Mads.

Yes, well, first of all, I think it's very important, as others before us have done, to not just classify GLP-1 agonists or analogs as a once-weekly or once-daily, because within the once-daily class, there are huge differences. For instance, between the liraglutide and lixisenatide,I need say no further in that regard. And within the once-weekly class, there's also big differences between these agents, both in terms of convenience and in terms of the efficacy profile that we offer both on glycemic and weight control. So I don't think you can make any generic statements. What I can say though, having been part of it, is that the SUSTAIN 6 program is one where there was a high degree of investigator enthusiasm to join the program because people -- the investigators are to be -- had been, of course, informed totally about the Phase II efficacy results and how we actually also managed the titration phase in a more softer manner in Phase III so as to avoid side effects and so on. So we are happy to say that we actually were able to do the entire recruitment of more than 3,000 patients within the last calendar year. And that means that we are on-track for the entire SUSTAIN program since this is deemed to be gating for the New Drug Applications. Lars Rebien Sørensen: Jesper, you want to get back with a further comment?

Yes, just want to make sure that I made it clear that the comment I made on gross to net, that was on the global sales. And if you zoom in on the U.S. sales, the reduction percentage is about 45% that you take out of the gross into net. So it depends on whether you look at global sales, where it's about 1 percentage point. And if you zoom in on the U.S., the effect will be approximately 2%.

The next question is from Richard Vosser of JPMorgan. Richard Vosser - JP Morgan Chase & Co, Research Division: Richard Vosser from JPMorgan. Just 2, please. Just, we saw, I think, in the end of last year, some slowdown in the insulin market growth. Just wondering what's causing that. Are you seeing the slowdown due to the SGLP-2s, and given there's a second one -- a second and, probably, third coming to market, should we be expecting an impact there? And then secondly, just on semaglutide, just whether you've seen any data around the tolerability, whether the better titration profile is able to manage the tolerability profile of that product, whether you've been able to see anything from the trial so far. Lars Rebien Sørensen: Thank you very much, Richard. Again, I'd like to start with Mads because it was correct that we did see, in the Phase II trials of semaglutide, a relatively harsh reaction and tolerability. But we have tried to amend that by the titration scheme. And Mads, what is the outlook on that parameter?

Yes. Well, first of all, what happened in Phase II, as you probably are aware, Richard and colleagues, is that we basically underestimated the potency of the drug, meaning, that in principle, some of the groups went on to a weekly dose that corresponded to 1.8 milligram of Victoza on a daily basis without basically titration. So there are 2 ways of rectifying that: One is by starting at a lower dose level, and the other is by adding a longer dosing period, i.e. 4 weeks between each titration step. Both of these have been instigated and built into the Phase III SUSTAIN program. And even though, of course, I'm blinded as, I hope, we all are, to the conduct of these trials, I am aware of the blinded discontinuation rates. And at this point in time, we are, of course, not going for a year with the SUSTAIN 6, I can inform you that discontinuation rates are markedly lower than what we saw in Phase II, consistent with the notion that we've been able to enhance the GI tolerability. Lars Rebien Sørensen: Thank you very much. And with regards to the insulin market growth, it is correct that towards the latter part of the year, we've seen somewhat of a slowdown in Japan, in Europe and in the United States. But again, I mean, we have to be very, very careful in judging on these numbers on a quarterly basis. We also have the issue that IMS has decided not to report on the same comparables because of lack of access to vital data in the U.S. market and then they're going to try to restate their numbers backwards so that we perhaps get a better fix on this in connection with the Q1. We think the impact so far from the SGLP-2 is too small to really have been the culprit in this regard. So uncertainties on the quarterly numbers, uncertainty on the statistics, we hope we'll get a better fix in Q1.

The next question is from Sachin Jain of Bank of America.

It's Sachin Jain, Bank of America. A couple of questions please. Firstly on pricing. Your cash pricing in the pricing environment is strong but more competitive. To the extent you can, I wonder if you could just give us some color on what pricing is assumed within your guidance broadly? And if it ends up being better than expected as, I guess, last year, does that benefit drop through to the bottom line or would you reinvest? And then a couple of questions on hemophilia actually, if possible. NovoEight launching in markets, just wondering if you could reappraise of how you're positioning that product. Is it differentiated on the inhibitor profile or more of a biosimilar? And then just, Mads, just perspective on the Baxter Phase III recombinant factor VII, because I think it's due data this -- later this year. Any perspectives on that as a potential competitor to NovoSeven? Lars Rebien Sørensen: Thank you very much, Sachin. Just writing down here. In terms of pricing assumptions, it is correct that when we gave the guidance last year, in connection with the Q3, since then, there was a price adjustment in the U.S. So the pricing platform, so to speak, from that perspective is slightly more positive, which is also contributing to the fact that we could raise the upper end of the range and the guidance. In terms of what the primary line is going to look going forward, it is somewhat uncertain. We have -- I mean, just take the situation -- the basal segment seems to be a situation where the pricing can go upwards. But on the contracting side, we talked, for instance, GLP-1 where we were up with against Bydureon with our Victoza, pricing environment was soft, to say the least, on our part, and the same thing on the insulin. So it varies a little bit from product category to product category. But I would agree with you that the pricing environment is slightly tougher in general in the United States, and the pricing environment in Europe is as it is. And in Japan, the same picture that you've known for years, basically. Hemophilia, our intention -- we have very, very good clinical data to support the launch of NovoEight, in that we have in our core package not seen any inhibitors. This is, of course, not something that we can guarantee, and therefore, what we are doing is we are launching this as a sort of a branded generic product up against the leading products in the category and see relatively nice interest initially in the markets where we have brought it out. And then Mads, there was a question on Baxter's factor VII recombinant.

Yes, yes, and just to add to what Lars is saying, we actually do believe that throughout [indiscernible] for NovoEight, we see it as an expansion in the potential of these compounds to be both reliable and safe, and also to be carried around due to temperature stability, which is actually essentially good for this particular NovoEight offering. So we're happy about it, and now, as we mentioned, we're launching it. The Baxter factor VII is one which is essentially, to some extent, different from NovoSeven because they're using a Chinese hamster ovary serum-free process, and that means that if they postpone in terms of the media being used, continuation media, and in terms of the cell system being used from NovoSeven. So Baxter will have not to piggyback on the safety database that exists for NovoSeven, which is literally millions of infusions that are, at this point in time, but have had to create their own, and of course, that will be somewhat more modest based on the trial that's below 100 patients. So we still NovoSeven as the factor VII with a proven safety track record in terms of not creating, for instance, a single patient over 17 years with any degree of inhibitor information. But they are doing their Phase III and we would expect competition from them with their molecule a couple of years into the future. Lars Rebien Sørensen: And then Jesper, did you have any additional comment on the pricing environment?

To be just specific on the assumption, we are not assuming the same degree of frequency in price increases in the U.S., but potentially, it may be seen in the second half, some inflation clause adjustment in prices. But also bearing in mind the more competitive pricing environment, which is likely to lead to a further erosion of the net prices and maybe see the gross-to-net percentage increasing by 1 to 2 percentage point in the U.S. due to the portfolio contracts we currently are having. Lars Rebien Sørensen: But of course, it will also be depending on very much what mix we have of our price, whether it's basal insulins or whether it's short-acting and GLP-1s. So thank you very, Jesper, for that clarification, and thanks for the question.

The next question is from Martin Parkhøi of Danske Bank. Martin Parkhøi - Danske Bank Markets, Research Division: Martin Parkhøi from Danske Bank. Just a question, firstly, on biosimilar Lantus. I know that you have also said at [indiscernible] that you see that having a mass impact on you. But if Sanofi will be successful in getting a 30-month stay, if they file a patent infringement against Lilly, don't you think that, that could prolong the positive pricing environment we see in the basal segment right now? And then secondly, just again with the ESI contract, what kind of pushback have you seen from -- heard from patient organizations, from doctors, and also from patients that they have been forced to go all to Biogen? Lars Rebien Sørensen: Thank you very much Martin. This is Lars here. First, on the Sanofi, the Eli Lilly situation, it's a little bit delicate for us to comment on how these 2 players are going to react. First of all, we don't know the composition of the Lilly product and whether or not the patents that Sanofi has can be brought to bear about that. But I mean, if all other things being equal and a 30-months stay is enacted, with all the uncertainties that you can predict into that, then of course, it would change the competitive picture in the basal market and defer that generic thread, which would, all other things being equal, be a positive to Novo Nordisk, I would imagine. On the ESI side, that's a little bit too early to really give any concrete quantitative information on how the patient -- it's clear that the patients and the doctors, in some -- to some extent, see the 2 products as different. The question is whether that difference is big enough to warrant the physicians to make effort to push back on the plan to have Victoza. And it's also uncertain as to whether the difference is big enough for the patients to want to choose a different plan. So -- but we'll give some more guidance on that, but it's, certainly -- we have seen positive feedback from patients and physicians that they prefer Victoza. Certainly, we have.

And for patients who are -- who was existing on Victoza, there has been numerous examples of obtaining authorization for continued medication where, of course, winning new patients for health care insurers covered by the Express Script services is significantly more challenging. Lars Rebien Sørensen: Yes, that's correct. Good.

Our next question is from Peter Verdult of Citi.

Peter Verdult, Citi. Just 2 questions. Just on Express, Lars, can you just, in terms of Novo regaining or negotiating back access to the formulary, can you remind us what timelines Novo is working through? And then just one for Jesper, just a confirmation. We have seen -- and this is a follow-on from Sachin's question. Pretty aggressive pricing dynamic in basal, that's probably likely to continue. Now I'm not asking you to speculate, but I just wanted to confirm that a similar level of price increase for Levemir that we enjoyed in 2013 is not baked into your assumption for 2014? Lars Rebien Sørensen: Yes. Jesper, why don't you comment on that to start with. Then I'll give a little song and dance on ESI.

Peter, first, we're going into the year based on a list price adjustment of happening for Levemir towards the end of 2013, and hence, you could say that the first price increase is given. I wouldn't expect the same frequency of price increases in 2014, but I did say that I anticipated, in the second half of 2014, there could be an inflation plus base price adjustment. But that's, of course, very speculative and will depend on the market condition at that point in time. And I also noted that the contracting environment in the U.S. will continue to be challenging. And hence, the gross-to-net sales effect will -- or the net effect, will be smaller, both due to prior agreement with a number of plans on what effect does the eventual price increases have on their effective prices, and also due to continued contracting on smaller plans in the U.S. But there's no major a significant plans up for grabs near term. Lars Rebien Sørensen: Yes. And then in regards to the contracting, it is so that the ESI contract is a 2-year contract as it relates to commercial, and that excludes the Medicare Part D contract. And the commercial part is significantly larger than the Part D part. So that's a 2-year contract. And we were of course, driving ourself into a negotiating position in recent time to ensure that we have a shot there at that the next time around. And whether or not we can do anything to disrupt the current contract, that remains uncertain and, certainly, nothing that I'm going to speculate on in public.

The next question is from Jo Walton of Credit Suisse. Jo Walton - Crédit Suisse AG, Research Division: On the insulin front, can you show us a little bit more about the FlexTouch plan and whether you think the value is going to be a significant commercial advantage? It appears that it's not just the molecule but it's the device that doctors look at. And could we see this taking you ahead of, let's say, Lantus SoloSTAR going forward? And secondly, on the emerging markets, you've talked about the disruption in terms of foreign exchange. But are you worried that there could be an economic slowdown in some of these countries, which makes it more difficult for governments to place tenders? Or have you made any adjustment to your effective underlying growth rates in emerging markets because of this currency disruption? Lars Rebien Sørensen: Thank you very much, Jo. This is a great, great question. The last one. Of course, it's not just currencies. Currencies are reflecting the underlying competitiveness of the nation and their trading patterns. So Jesper, can you just talk a little bit about -- of course, we have factored this into something that we can, but it seems like the situation has deteriorated in recent week. So -- and then we'll get back to Mads [indiscernible], whether that will be enough to drive a change in uptake in the U.S. versus SoloSTAR.

Thanks, Lars. Yes, Jo, I think you are right. These are profound changes that have occurred over the last 14 days. What we have factored in here is the currency effect, and we have not factored in any significant commercial changes in the individual markets. It is clear that we have in our plans for a country like Argentina where, I would say, these developments was probably more foreseen. There, we have had a plan which forecasted some challenges in terms of currency turmoil. So that has, to some degree, been factored in the plans already, where some of the other markets, I would say, no significant changes have been made so far. I think this, everything else being equal, entails a risk of not being able to launch our newer products and more continuing with current products. And then it clearly also entails a risk of not being able to basically get compensating price increases in the market in a market, for example, like Turkey, immediate following the devaluation but suffering some impact from that. I think that is highly likely. I also would like to note that we, in a number of the market, do have compensating factors. We have a very large, not the world's largest insulin-filling facility in Brazil, which give us a Brazilian cost base to offset some of the income we have from that market. We are also -- in India where we have decent operations in terms of a global shared service center where we deploy some 650 Indians working with offshoring services and that do provide us with some local costs, which everything else, gives some hedge to us. But longer term, this impacts the growth level from these markets, and I think we will have to make some adjustments during the year. But those have not been reflected in our forecast as of now. Lars Rebien Sørensen: And Jo, it is correct, as you mentioned, that once the pharmaceutical ingredient becomes comparable, then the device difference does play, normally, a role in adoption and, thereby, capture rates. And so, I guess, your speculation is will that have any significant impact on your ability to continue to gain share in the United States or regain share in the segments where you have lost share. Mads, would you just talk a little bit about that in relationship to FlexTouch versus SoloSTAR?

Yes. So it's absolutely as Lars describes it, that when you have -- when you don't have parity, i.e. when 1 drug is superior to the other drug, then the device can't do that much about it. But when you do have parity, i.e. drugs that like Levemir and Lantus are perceived to be more or less in the same ballpark in terms of safety and efficacy and so on, then the device can actually be the swing factor in a situation where there's equal access in reimbursement and so on. And of course, with the FlexTouch benefits that the most predominant being the ultra injector function, but also the fact that it's ergonomic and has a high degree of legibility on the scale, these have given us a 70% to 80% patient preference in many different territories where it's been tested out. So it's not that we expect any dramatic effect, but that it will help us sustain the positive momentum that we have for Levemir and also have news stories to tell about innovation, both for NovoLog and Levemir in the U.S. Lars Rebien Sørensen: Yes, so there's also an internal motivation factor in the -- I mean, the sales reps get something new in the bag, and that, of course, highly encourages them to go back to the same audience and talk one more time. So ladies and gentlemen, we unfortunately run towards the end. We would like to take one more question, please.

Our final question will come from Tim Race of Deutsche Bank.

Congratulations to Kare for the promotion. First question, actually, just on that, just the role of President, how does that differ from the role of CEO? And should I view this as something more like a succession planning longer term? Just any comments on that would be good. And just on your -- in terms of the contracting situation on the Express, just further detail perhaps in terms of have you seen any employer plans decide to opt out of these? And have you seen any sort of movements there or any early signs that actually the affect might not be quite as bad? Lars Rebien Sørensen: Thank you very much, Tim. Yes, this is Lars Rebien here. Well, the way that we look at this is we have given Kare a promotion to President for a couple of reasons and with a couple of intentions. One is to recognize his contribution during the last 10, 12 years of running the most complex part of our organization, mainly manufacturing and our whole commercial organization with some success, I would say. Also, a recognition of the fact that we do believe he can do more, uncannily as it may sound. So this appointment will mean that he and I will share the responsibility of managing both internally to watch the company, the company agenda and towards the Board of Directors, our interaction with the Board. And no reporting lines are being changed as a consequence of this, and there's no change in the structure of our meetings. It will have the benefit, for me personally, that I will alleviate part of my agenda so as to enable me to spend more time in the key markets, and in particular, in the United States, to understand that increasingly complex and very exciting marketplace for us. So all in all, we believe that's a good use of our time, and this is not to be seen as a succession move other than of course, it gives Kåre an opportunity to develop his leadership skills. So you could say that he's getting a head start, if you want, in as far as that goes. Jesper, any opt outs as a result of the Express Scripts?

On the national formulary, there's only been a few opt outs. The all 5 employers covered us are continuing under the national formulary. I would like to reiterate what I said earlier that, in general, patients who was on Victoza treatment under ESI national before has found it easier to obtain grandfathering for their reimbursement, whereas it's, of course, challenging for physicians to get authorization for patients not previously on Victoza. So in that sense, it's more challenging. And then in terms of the impact so far, we have indicated that the effect was to the tune of 1% on global sales and in the ballpark of double that on U.S. or a bit more than double that on U.S. sales, and I think that still stays. We are seeing an impact overall on our business in that magnitude. But as Lars also alluded to, we would have to get to the Q1 quarter to see whether that estimation was right. You do have to be aware that the effect on the NBRxs will be profound in the first 3 months of a changed formulary. We saw that when United Healthcare introduced a block on NovoLog back in, I think, it was 2011, and on the other hand, when we won the CVS Caremark contract for our NovoLog. Then, we also saw that profound shift over the next 3 months in terms of NBRxs where the effect on total script is more modest. Lars Rebien Sørensen: So ladies and gentlemen, we do appreciate that you called in today to listen to this announcement. We chose to announce our results on a quite chaotic day in Denmark. For those of you that are not residing here, we have a chaotic political situation in that the -- one of the leading parties of the government correlation has collapsed, and we have a new political situation in Denmark, and this is driven by a wish to have Goldman Sachs to invest in an oil and gas and windmill company in Denmark. So quite hectic and bizarre, and therefore, we appreciate your attention to ourselves. Thank you very much.

That will conclude today's conference call. Thank you for your participation, ladies and gentlemen. You may now disconnect.