Novo Nordisk A/S (NVO) Lars Rebien Sørensen on Q2 2016 Results - Earnings Call Transcript

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Novo Nordisk A/S (NYSE:NVO)

Q2 2016 Earnings Call

August 05, 2016 7:00 am ET

Executives

Lars Rebien Sørensen - President & Chief Executive Officer

Mads Krogsgaard Thomsen - Chief Science Officer & Executive Vice President

Jesper Brandgaard - Chief Financial Officer & Executive Vice President

Jakob Riis - EVP-China, Pacific & Marketing

Analysts

Richard Vosser - JPMorgan Securities Plc

Simon Baker - Exane Ltd.

Sachin Jain - Bank of America Merrill Lynch

Ronny Gal - Sanford C. Bernstein & Co. LLC

Tim M. Race - Deutsche Bank AG (Broker UK)

Michael Novod - Nordea Bank AB (Denmark)

Seamus Fernandez - Leerink Partners LLC

Keyur Parekh - Goldman Sachs International

Operator

Good day, ladies and gentlemen, and welcome to the Quarter Two 2016 Novo Nordisk A/S Earnings Conference Call. Today's conference is being recorded.

At this time, I would like to turn the conference over to Mr. Lars Rebien Sørensen, CEO. Please go ahead, sir.

Lars Rebien Sørensen - President & Chief Executive Officer

Thank you very much. Welcome to this Novo Nordisk conference call regarding our performance in the first half of 2016 and the outlook for the full year. I'm Lars Rebien Sørensen, CEO of Novo Nordisk, and with me I have Chief Financial Officer, Jesper Brandgaard; and Mads Krogsgaard Thomsen, our Chief Science Officer.

Also present and available for the Q&A session are Executive Vice President-China, Pacific & Marketing, Jakob Riis; Lars Fruergaard, Executive Vice President-Corporate Development and Vice Chair of our Operations Committee. Present are also our Investor Relations officers.

Today's earnings release and the slides for the call are available on our website, novonordisk.com. And as usual, the conference call is scheduled to last one hour. We'll start with the presentation as outlined on slide number 2. The Q&A session will begin in about 25 minutes. And please note that this conference call is being webcast live, and a replay will be made available on our website.

Turn to slide number 3. As always, I need to advise you that this call will contain forward-looking statements. Such forward-looking statements are subject to risks and uncertainties that could cause the actual result to differ materially from expectations. For further information on the risk factors, please see the earnings release and the slides prepared for this presentation.

Sales growth in the first half of 2016 with 7% measured in local currencies, and 5% in Danish kroner. All regions contributed positively to sales in local currencies. The U.S. continues to be the largest growth driver, however, both International Operations within China contributed with double digit sales growth measured in local currencies. Sales growth was realized within both diabetes care and biopharmaceuticals, with the largest contributions coming from Victoza, Tresiba and Norditropin. And that is driven by a non-recurring Medicaid rebate adjustment in the United States in the first quarter of 2016.

The rollout of our new generation insulin especially Tresiba is progressing well. New generation insulin now accounts for a combined share of 28% of growth measured in local currencies. The Annual ADA meeting in New Orleans t-cell data from the LEADER trial was presented, showing that Victoza significantly reduce the risk of major cardiovascular events with 13% compared to placebo.

In May, IDegLira received a positive 16-0 vote in favor of approval from the FDA Advisory Committee.

Moreover, we've completed the small phase 2a trial with the once daily oral insulin analogue OI338GT, and the results are generally encouraging. Finally, our long-acting factor IX for treatment of hemophilia, N9-GP has been filed for regulatory approval in the United States.

Turning to financials, operating profit grew 8% in local currencies when adjusting for the partial divestment of NNIT and income related to the out-licensing of assets for inflammatory disorders, both in 2015.

Slide number 5. In the first half of 2016, the overall sales growth of 7% in local currencies was derived from a balanced growth across the regions. U.S. continued to be the largest growth driver, followed by international operation in Region China, which accounted for 21% and 14% of growth in local currencies. Sales in the U.S. increased 7% in local currencies and 7% in Danish kroner. The growth was driven by Victoza for which the sales increased 16% in local currencies aided by the high growth of GLP-1 market. Overall, the sales growth in the U.S. was positively impacted by approximately 1.5 percentage point from a non-recurring rebate adjustment in the Medicaid patient segment in the first quarter of 2016.

I will revert to the relatively modest U.S. sales growth in Q2 on the next slide. Within International Operations, sales grew 11% in local currencies and decreased 2% in Danish kroner. Reported sales are negatively impacted by depreciation of the Argentinian pesos and the Venezuelan bolivar. Modern and new generation insulins were the largest growth drivers within International Operations accounting for 39.19% share of growth in local currencies respectively. Moreover, Victoza grew by 22% in local currency mainly driven by a number of countries in Middle East and Latin America.

Sales growth in Europe was 2% in local currencies and 1% in Danish kroner. Growth was mainly driven by recent launch of products such as Tresiba, Xultophy and NovoEight, as well as the positive contribution from Victoza and NovoSeven. However, the growth was partly offset by a 2% decrease in modern insulin sales in local currencies mainly due to increased competition in the basal segment and continued decline of the premix segment.

In the first half of 2016, sales in Region China increased 10% in local currencies and 5% in Danish kroner. Sales growth was driven by an 18% increase in sales of modern insulins, aided by growth of the overall diabetes care market and a delayed provincial bidding process. Pacific sales grew 8% in local currencies and 9% in Danish kroner. The sales growth is mainly driven by a 23% increase in Victoza sales in local currencies, reflecting continued expansion of the GLP-1 market in Japan and Canada.

Sales growth in Pacific is primarily driven by a continued strong uptake of Tresiba in Japan with the current market annual share of 39% of the basal insulin segment. The growth was partly offset by a decline in overall insulin market volume in Japan and lower human insulin sales in the region.

Turn to slide number 6. In the second quarter of 2016, total U.S. sales grew 3% in local currencies compared to 2015. The quarterly sales growth was driven by Tresiba, Victoza and Saxenda. Victoza increased by 15% in local currency mainly driven by the high underlying GLP-1 prescription volume growth of more than 30%.

In the second quarter, Tresiba sales in the U.S. were close to DKK0.5 billion in local currencies. However, this was offset by an 8% decrease in the sales of modern insulins in local currencies mainly due to wholesaler inventory management and NovoLog contract loss, rebate phasing and lower impact from list price increases. Hemophilia sales in local currencies decreased 12% following the increased competitive pressure and a high level of ongoing clinical trial activities.

Turn to slide number 7. From a product perspective, sales growth was realized within both diabetes care and biopharmaceuticals, with the majority of growth coming from Victoza and new-generation insulin. The sales of new-generation insulins grew 174% in local currencies and accounts for 28% of total growth. Sales in modern insulins were unchanged in local currencies and declined 2% in Danish kroner.

International Operations and Region China contributed positively to the modern insulin sales growth but was offset by declining sales in the United States, Europe and Pacific. The increase in other diabetes and obesity care reflects a significant positive contribution from Saxenda in the United States. The growth of the biopharmaceuticals was primarily driven by Norditropin which grew 19% in local currencies, accounting for 20% of sales growth.

The increased sales of Norditropin is derived from the U.S., reflecting a positive non-recurring adjustment to rebates in the Medicare patient segment in the first quarter of 2016. In the first six months of 2016, the hemophilia sales declined 1%, measured in local currencies, driven by lower sales of NovoSeven in the U.S., partly offset by the rollout of NovoEight in Europe and United States.

Turn to slide number 8. In the first half of 2016, sales growth of Victoza increased 14% in local currencies, driven by the U.S. which accounts for 76% of total Victoza sales growth. In the U.S., Victoza sales increased 16% in local currencies, which reflects and underlines GLP-1 prescription volume growth of more than 30%. As a result, the GLP-1 segment now accounts for 10% of the total U.S. diabetes care margin.

Despite the intensified competition in the GLP-1 segment, Victoza continues to grow its sales volume and has recently passed $2 billion worth of sales in the U.S. over a 10-month, 12-month period. With a market share of 52% of total scripts in the U.S., Victoza remains the market leader in the U.S. GLP-1 segment.

Turn to slide number 9. Tresiba has now rolled on 45 countries and the market uptake continues to be successful in countries with the same level of reimbursement as insulin glargine U100. It is especially encouraging that Tresiba has increased its basal insulin market share to 39% in Japan despite a strong biosimilar uptake. Worth noting is the trends seen in the Netherlands, Spain and Denmark, where full reimbursement has recently been obtained, and market penetration has immediately accelerated. Furthermore, Ryzodeg and Xultophy are now launched in six countries and seven countries respectively.

Turn to slide number 10. Tresiba has now reached 11% share of new-to-brand scripts, and 2.9% share of the total number of scripts in the basal insulin segment in the United States. Moreover, around 80% of the Tresiba volume is U200 formulation, indicating that healthcare professionals appreciate – and patients as well, appreciate the benefit provided by this higher concentration of Tresiba.

In the basal segment, our total new-to-brand prescription market share is 31%, which is driven by the steady uptake of Tresiba. Following the recent contract negotiations, we anticipate that Tresiba will continue to have wide formula recoveries of around 70% in 2017.

Turn to slide number 11. The majority of the U.S. formulary negotiations for 2017 has been finalized, including negotiations with the three largest payers. The market access to our key products is anticipated to remain largely unchanged compared to 2016. Worth noting is Tresiba currently has wide coverage, which is expected to be maintained in 2017. More than 70% of the patients in managed care and Medicare Part D have access to Tresiba.

Following the contract negotiations, the average price after rebates are expected to be low to mid single digit percentage lower compared to the level in 2016. This is driven by challenging pricing environment especially in the basal segment and human growth hormone segments.

With this, over to Mads for an update on the R&D.

Mads Krogsgaard Thomsen - Chief Science Officer & Executive Vice President

Thank you, Lars. Please turn to slide 12. At the Annual ADA Conference in New Orleans in mid-June, detailed results from the LEADER trial were presented, showing the Victoza improved the primary composite endpoint significantly by reducing the risk of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke by 13% compared to standard of care. The improvement was driven by all three MACE components. Mortality-wise, there was a significant 22% reduction in cardiovascular death in the Victoza, and all-cause mortality was significantly reduced by 15%.

The LEADER trial also showed that Victoza led to a 22% significantly lower rate of onset of diabetic kidney disease. Victoza exhibited a safe and well-tolerated profile that was generally consistent with previous liraglutide studies. And the DUAL safety and efficacy sNDA will be submitted to the FDA within the next three months.

Also, as regards to the FDA, Novo Nordisk has now completed all post-approval requirements for Victoza related to pancreatitis and pancreatic cancer. As part of this, we've used the Optum research database to perform an epidemiological five-year prospective propensity score match cohort study conducted between 2010 and 2014 and comparing the safety of liraglutide with five different classes of anti-diabetic agents. The study has now been reported with no findings of increased risk including pancreas cancer and pancreatitis. For a number of macro and micro vascular complications, the incidence was found to be lower for the liraglutide group compared to the other groups. As is the case for our randomized controlled clinical trials, we also plan to publish these data.

Please turn to slide 13. In June of this year, we completed a phase 1 crossover trial where 60 type 1 diabetes subjects were randomly assigned to receive insulin degludec or insulin glargine U300, also known as Toujeo for 12 days. Though within subject day-to-day variance in the glucose lowering effect was approximately four times lower for degludec when compared to insulin glargine U300, the variance was consistently lower over the entire 24-hour period but especially pronounced between 6 hours and 18 hours after dosing. Furthermore, insulin glargine U300 demonstrated a statistically significant 30% lower potency compared to insulin degludec.

To investigate the clinical impact of these benefits of insulin degludec further, we'll initiate a large phase 3b head-to-head trial of insulin degludec versus insulin glargine U300 with expected study start in 2017.

Please turn to slide 14. During the second quarter, IDegLira, a combination of Tresiba and Victoza, received a positive 16 to 0 vote from the FDA Advisory Committee recommending approval for the treatment of adults with type 2 diabetes based on data from five completed trials in the DUAL phase 3 clinical trial program. The NDA for IDegLira was submitted to the agency in September last year under the PDUFA-5 regulation and accordingly the FDA is expected to complete its review of Xultophy by September.

In the first half, we additionally completed a small phase 2a trial with the once-daily oral insulin analogue OI338GT and the results were generally encouraging with approximately 2.5 millimolar fasting plasma glucose reduction observed for both OI338GT and the Lantus comparator arm. We're currently assessing the target product profile for oral basal insulin, as well as the investment needs of the program and we expect to have more detailed information regarding potential next steps in the second half.

Based on portfolio considerations, the OI320GT oral insulin project has been discontinued. In April, we completed the phase 2a proof-of-concept trial with a GLP-1/GIP dual-agonist NN7709 intended as a once-daily treatment for people with type 2 diabetes. The trial made its primary glycemic endpoint, but was discontinued based on portfolio consideration.

Finally, in May of this year, we filed a long-acting factor IX product, N9-GP for the treatment of hemophilia B for regulatory approval in the United States. We expect regulatory action in the U.S. during the first half of next year.

Please turn to slide 15. In the past three months, we've completed the described oral insulin trial. We've received a unanimous positive vote from the FDA AdComm recommending the approval of IDegLira, and we filed a BLA for regulatory approval of long-acting factor IX.

In the next three months based on the SWITCH 1 and 2 trials, we plan to file for a label update in the U.S. for Tresiba as this is also the case for Victoza following the LEADER trial. In September, at the EASD conference in Munich, detailed data will be presented from the SUSTAIN 6 cardiovascular trial which is a double-blind trial investigating the long-term cardiovascular and other safety outcomes of a half and a whole milligram of injectable once-weekly semaglutide compared with placebo both in addition to standard of care.

In the trial, approximately 3,300 people with type 2 diabetes were all treated for 104 weeks. As previously communicated, the trial included around 250 strict MACE events and achieved its primary endpoint of showing non-inferiority of major CV events with semaglutide compared with placebo.

Subsequently, a statistically significant reduction in strict MACE events for semaglutide versus placebo was found. However, with a comparatively low number of strict MACE events and a treatment period of only 24 months, the degree of recall of the results are obviously not directly comparable with the very robust LEADER trial outcomes.

Nevertheless, as semaglutide appears to be a more efficacious drug, we would expect to see a more profound anti-arteriosclerotic GLP-1 effect for semaglutide in high-risk type 2 diabetes subjects. This expectation will be the subject of future cardiovascular outcome investigations for semaglutide. Finally, we expect the FDA to complete its review of Xultophy by September and a fast-acting insulin aspart by October of this year.

With that, over to you, Jesper, for an update on the financials.

Jesper Brandgaard - Chief Financial Officer & Executive Vice President

Thank you, Mads. Please turn to slide 16. During the first half of 2016, sales increased by 7% in local currencies and by 5% measured in Danish kroner to DKK54.7 billion. Cost of goods sold increased by 7% in the first half of 2016 resulting in a reported gross margin of 84.9% compared to 85.2% in the first half of 2015. The decline reflects the negative currency impact of 0.1 percentage point.

The underlying growth – gross margin is negatively impacted by ramp-up cost for new manufacturing capacity. However, it is partly offset by a positive impact from product mix and net prices as well as higher Victoza sales and non-recurring Medicaid rebate adjustment as we reported in Q1.

Sales and distribution costs increased by 5% in local currency and by 2% in Danish kroner to DKK13.6 billion. The increase in cost is driven by the U.S. related to Tresiba launch as well as the continued rollout of Saxenda and NovoEight. It is further driven by sales force investments in International Operations in China. Research and development costs increased by 6% in local currencies and Danish kroner to DKK6.6 billion. The increasing cost reflects higher research cost for diabetes and obesity projects, partly offset by slightly lower development cost due to the wind-down of the DEVOTE, SUSTAIN and SWITCH programs.

In the first half of 2016, the oral semaglutide phase 3a program, PIONEER, was initiated, partly offsetting the decline in development costs. In the first half of 2016, administration cost increased by 6% in local currencies, and by 2% in Danish kroner to DKK1.8 billion. The higher administrative costs are mainly driven by higher employee-related costs in International Operations to support the growing organization in that region.

The net other operating income was DKK438 million compared with DKK3.1 billion in 2015. This significant difference reflects the nonrecurring income from the partial divestment of NNIT, as well as nonrecurring income related to the out-licensing of assets for inflammatory disorders both in 2015. Operating profit decreased by 3% in local currencies and by 6% in Danish kroner to DKK24.8 billion. Adjusted for the previously mentioned nonrecurring income, the growth in operating profit was 8% in local currencies and 5% reported in Danish kroner. Net financial items showed a loss of DKK251 million compared with the loss of DKK3.3 billion in 2015, driven by a favorable development in net losses on foreign exchange contracts.

Please turn to slide 17. Overall, there was a negative currency impact during the first half of 2016. The development is primarily related to a slightly lower average U.S. dollar and Chinese yuan compared to the first half of 2015. The development is further related to the devaluation of the Argentinian peso and the Venezuelan bolivar, which are both un-hedged currencies.

Please turn to the next slide for the financial outlook. For 2016, the range of sales growth has been narrowed from previously 5% to 9% to a new range of 5% to 7% measured in local currencies. This narrowed range reflects expectations for continued robust performance for Victoza and Tresiba, as well as a contribution from Saxenda and Xultophy. These sales drivers are expected to be partly countered by the impact from a contract loss in the U.S. for NovoLog and NovoLog Mix. The loss of exclusivity for products within hormone replacement therapy in the U.S., intensifying competition within diabetes and biopharmaceuticals especially in the U.S., as well as adverse macroeconomic conditions in several markets in International Operations. Reported sales growth is expected to be around two percentage points lower than the local currency guidance.

For 2016, operating profit growth adjusted is now expected to be 5% to 8% measured in local currency, again here, adjusted for nonrecurring income. The expectations for operating profit growth reflects growth in sales and distribution costs to support continued launch activities, as well as research and development to support the progress of our pipeline. The change in the expected operating profit growth range reflects the impact from the changes in sales growth outlook.

Reported operating profit growth is expected to be around three percentage point lower than the local currency guidance. We now expect the net financial items to show a loss of around DKK600 million. The current expectations reflect losses associated with foreign exchange hedging contracts mainly related to the U.S. dollar, Japanese yen and Chinese yuan.

The effective tax rate for 2016 is still expected to be between 20% to 22%. Capital expenditure is still expected to be around DKK7 billion in 2016, which primarily reflects investments in an expansion of the manufacturing capacity for biopharmaceutical products, additional capacity for active pharmaceutical ingredient production within diabetes care as well as the expansion of the diabetes care filling capacity and the construction of new research facilities.

Depreciation, amortization and impairment losses are still expected to be around DKK3 billion. We now expect a higher level of free cash flow which is forecasted to be in the DKK38 billion to DKK41 billion range. The upgrade primarily reflects settlement of a number of tax cases with tax authorities.

Please turn to slide 19.

Lars Rebien Sørensen - President & Chief Executive Officer

Thank you very much, Jesper and Mads. Overall, we're satisfied with the performance of the first six months where Victoza and Tresiba continue to deliver strong sales growth. Region China improved faster than expected. In the U.S., the market environment is becoming increasingly challenging and contract negotiations for 2017 have reflected an intensified price competition. In spite of this, we see significant growth opportunities based on our strong diabetes care product portfolio.

We're now ready to take the Q&A. May I kindly ask all participants to restrain themselves to two questions to allow as many of you to ask your questions?

Operator, we're now ready to take the first question.

Question-and-Answer Session

Operator

Thank you, sir. We take our first question from Richard Vosser from JPMorgan. Please go ahead. Your line is open.

Richard Vosser - JPMorgan Securities Plc

Hi. Thanks for taking my questions. First question, just on the U.S. pricing guidance, you've given us of low to mid, that seems relatively wide range. Could you give us an idea what impacts take the range from the bottom to the high, what things are still outstanding and what uncertainties there are on that?

And then, second question, just – I think we've all been anticipating some price pressure on the basal insulin market, but just wanted your views on whether you still have the ability to raise prices on areas such as Victoza and NovoLog where we haven't really seen that much price pressure and maybe the competitive dynamics are a little bit easier. Do you still think you can raise the list price and then give back some of that on rebates for those two products? Thanks very much.

Mads Krogsgaard Thomsen - Chief Science Officer & Executive Vice President

Thank you, Richard. I'll take the comment on the individual products just in rough terms, then I'll ask Jesper to comment on what the impact of the range that we have given, how that would impact if we end up in the low end or we end up in the high end. It is correct that we have all participated or anticipated that the basal segment would be impacted because of the entry of generics and because it's now in the future going to be a three-player market and with the concentration that we've seen on the buy-side. So, that has largely been anticipated and we have seen this year a negative impact on NovoLog, and NovoMix and in particular also because of contract loss that we have had in the U.S., which has resulted in a very strict control on behalf of the PBM. So, as we have ended up with a far fewer patients continuing on our products than we had anticipated, and that gives the net negative price component for us.

In the future for NovoLog and for the pre-mix segment, we are anticipating to continue to see modest negative price development. And we hope and believe that there will be a possibility for some positive impact from the GLP-1 segment given that this is largely becoming a competition between Trulicity and ourselves. But this is, of course, still uncertain as we don't know exactly what the competition is going to do in the GLP-1 segment. But our anticipation would be that there might be still some pricing power in the very strong franchise we have with Victoza.

But all of this has been factored into the guidance. And it's also including a negative price for 2017 on human growth hormone. But, Jesper, give us a little bit of a range on this.

Jesper Brandgaard - Chief Financial Officer & Executive Vice President

I think the understanding of low to mid would probably be in the 2% to 3%, to 5% to 6% range. And of course, there are a number of swing factors. I should highlight that this is the price impact we see on the entire portfolio of products in the U.S. And of course, then you get into a mixed discussion on what is the actual mix of our product sales is going to be next year. You will also get into discussions about what are the final negotiations on the plans that have not yet been closed out for 2016, what are going to be the impact from those plans, you're going to see how employers are going to sign off to the various plans that are being presented by the PBMs and variations in uptake and sign-on to those formularies can also have implications and, of course, the list price that Lars Rebien alluded to the exact timing of them in the year will also have implication for what is the annualized effect of it.

So, there is still a number of factors outstanding, including also how the movement is on patients from the commercial life to the Part D, et cetera, within the U.S. market would also have implications for our net revenue per product per patient. So, there's a number of swing factors. And of course, in a very positive scenario and the low end of the range, in an adverse scenario and the high end of that range, I think it is – this was the first opportunity we have to provide these data. As you, of course, are aware, the announcement by ESI and CVS/Caremark was out Monday. So, these were the first two of the really large PBMs to announce it. And hence, this was the appropriate time for us to comment on the pricing situation in the U.S. And as Lars also alluded to, this is both an effect of increased pricing pressure in basal insulin but also in growth hormone.

Richard Vosser - JPMorgan Securities Plc

Thank you.

Lars Rebien Sørensen - President & Chief Executive Officer

Thank you. Thank you very much. Next question, please?

Operator

Our next question is from Simon Baker from Exane. Please go ahead, sir.

Simon Baker - Exane Ltd.

Thanks for taking my questions. Just in terms of going back to the PBM comments in Express Scripts, they suggested in the commentary that the position of basal insulins was subject to review based on the impact of biosimilar. So, I just wanted to get an idea of how final the situation when Express Scripts ceases as it relates to Novo.

And then secondly, on Ryzodeg and Xultophy, if I back out the sales of placebo from next generation insulins and I get kroner sales of DKK81 million in Q1 and DKK80 million in Q2. I just wanted to know if there were any stocking issues which were responsible for that seemingly low growth or whether there are currency issues because one would have expected at this point in the albeit early stage of the launch that the sequential growth would be somewhat higher than that. Thanks so much.

Lars Rebien Sørensen - President & Chief Executive Officer

Thank you very much. In regards to the PBM situation and comments by ESI, it is our anticipation and our expectation that if we roll back or roll forward to 12 months, 18 months, that we will see a bifurcation of the basal market. So, there will be one group of products which would be viewed as similar. That would, of course, in particular, be Lantus and Basaglar because they are bio-similar, then it will be a question mark whether Toujeo will fall in that category. It is slightly different in terms of its potency and its action profile and then we had Levemir. So, all these products in my view would hopefully fall in one category. And then we have, based on our expectation, the SWITCH data will be able to improve the label of Tresiba, then we will find Tresiba in a separate category of the basal market. So, this will be our approach to any review that is taking place by the big payers and we hope to be successful in doing that.

In terms of the Ryzodeg, Xultophy, if you back out the growth of Tresiba, maybe I can ask Jakob Riis to comment on that or, yes....

Jakob Riis - EVP-China, Pacific & Marketing

I can cover on – it's basically reflecting the fact that we had to decide to withdraw Xultophy from the German market and hence there is a substantial decline during second quarter in the sale of Xultophy which impact the overall numbers and there's about a DKK20 million effect from Q1 to Q2 from that German situation and you should basically back that out from the underlying trend, but it's bright spot, Simon, that it looks flat.

Lars Rebien Sørensen - President & Chief Executive Officer

Thank you.

Simon Baker - Exane Ltd.

And just a quick follow-up on that. Are there any – I mean as well as sales being eliminated, are there any sales returns in there?

Jakob Riis - EVP-China, Pacific & Marketing

No. There's not anything of any significance to be counted in for Q3.

Simon Baker - Exane Ltd.

Great. Thanks so much.

Lars Rebien Sørensen - President & Chief Executive Officer

Thank you. Next question, please?

Operator

Next question is from Sachin Jain from Bank of America. Please go ahead.

Sachin Jain - Bank of America Merrill Lynch

Hi. Two questions on pricing, I'm afraid. I'm sorry, you've obviously commented on basal insulin pricing was the driver of 2017. Could you comment where you've seen any differentiation between Levemir and Tresiba in pricing into 2017 and whether you're able to use the ADA publication of SWITCH with any discussions?

Secondly, taking pricing to midterm. Obviously, with your midterm guidance or aspirations you issued at full-year results, I think within that was implied flat global diabetes pricing. Does that aspiration for global diabetes pricing flat in midterm still stand, and if not, how is the mix of pricing versus pipeline contribution in the midterm guidance changing? Thank you.

Lars Rebien Sørensen - President & Chief Executive Officer

Thank you, Sachin. This is Lars Rebien here. I'll just comment on the Levemir versus Tresiba pricing picture, and then Jesper will discuss what assumptions were behind our most recent long-term financial target and what we have seen happening in the meantime on price as well as on data to be put on the label.

With regards to Levemir and Tresiba, in certain channels, we are able to distinguish between Levemir and Tresiba, Tresiba being a higher-priced product and therefore taking home a higher net than Levemir. In other channels, we have to be more aggressive to get Tresiba onto the market, and there would be then in some channels no premium to Levemir or to Lantus for that matter.

Jesper Brandgaard - Chief Financial Officer & Executive Vice President

And in terms of the long-term financial guidance we provided in early February, we noted there that we had not assumed a positive impact from the LEADER trial and we didn't have full knowledge of the outcome of the SWITCH trial when we provided that guidance. It is also correct that on a global basis, we assumed that prices will be broadly flat. With the development we've subsequently seen for the two – for the U.S., it is apparent that the pricing assumption near term for U.S. is going to be slightly more adverse than what we had in our guidance. On the other hand, the labels that we can operate under for core products like Victoza and Tresiba are slightly better.

It is not so that you should anticipate that we, in any way, revised our long-term targets. We strive towards our long-term targets. We still believe that they are ambitious and relevant goals for Novo Nordisk to pursue based on a market-leading portfolio of diabetes care product and a diabetes care segment where patient numbers continue to evolve and each time we see an update on the annual number of diabetic patients around the world, we see a substantial increase, mid-single-digit percentage point increase in a number of patients. It's a good opportunity for Novo Nordisk to pursue, but clearly in a more adverse U.S. pricing environment.

Lars Rebien Sørensen - President & Chief Executive Officer

And just to add a small comment that the changed label that Jesper was talking about for Tresiba and Victoza is anticipated to happen mid- next year based on filing of data both of the SWITCH data and the LEADER trial. Thank you. Next question, please?

Operator

Our next question is from Ronny Gal from Bernstein. Go ahead, please, sir.

Ronny Gal - Sanford C. Bernstein & Co. LLC

Good morning, everyone. Thank you for taking my question. I'm afraid that we're going to have to stick with the pricing theme. So, just picking up on your last point in Sachin's questions about the midterm guidance, with the recent move by CVS and I kind of think what would Sanofi might do when they come in with a short-acting insulin in late 2017, it's just hard to say them being a soft teddy bear on obtaining market share on that. So, when we think about 2018 and 2019, should we think about the insulin that's taking another step down more broadly?

And second, on Tresiba, again, following on some of the comments made. You're making nice ability to differentiate with Tresiba in some accounts. But obviously in terms of the overall U.S. market, your penetration is kind of low. You've clearly suggested that this is going to be a product which will be marketed towards the broadest audience possible. Should we think about this product more right now as a product that will be targeting patients who have a high need to prevent hypoglycemia? Or do you still think the marketing strategy of looking for this as the premium applied-for-everybody product in the United States is still relevant?

Lars Rebien Sørensen - President & Chief Executive Officer

Thank you very much. This is Lars Rebien here. And let me answer your last question first. We believe that Tresiba is a premium product that should be broadly applied for all patients because it has a unique long duration of action, it has unique flexibility in terms of dosing anytime during the day and we have repeated the original finding of a significant lower hypoglycemia which I think is relevant from many, many patients; and therefore, in our view, it should be more broadly applied. And it is correct that in the arms race between Lilly and Sanofi, Sanofi has stated that it intends to further develop a short-acting range which will be biosimilars of Humalog to enter into the U.S. market.

I would say we'll have to see, of course. You'll have to ask Sanofi what they intend to do with it, what they intend to do in terms of price spot. I can tell you that the price picture that we are looking at in shorter-acting modern insulins in the U.S. is rock-bottom net pricing. And so, it would be rather difficult, I think, to anticipate that they would be going much lower. And we already discussed it a little bit that we saw a couple of years ago very, very aggressive pricing impact in the short-acting segment, but less so in recent 2016 and into 2017. So, I am not of the expectation that this would further significantly erode the short-acting price picture of modern insulins.

Ronny Gal - Sanford C. Bernstein & Co. LLC

Okay. Thank you very much.

Jakob Riis - EVP-China, Pacific & Marketing

And one could argue actually that Sanofi already has a fast-acting insulin that they could decide to apply an aggressive pricing strategy too in the U.S. if they wanted to. So, I think that's probably less of a concern. In terms of Tresiba progress, I think I just like to revert to what we said as our ambition level when we initiated the launch in the U.S. at the start of this year where we said we would be targeting getting to a 5% of the basal market within a 12-month period. I think the latest script data indicates that we are at 2.9% or so. So, I think we are well on track to achieve the broad positioning of Tresiba in the market. So, we're quite comfortable with the progress.

Lars Rebien Sørensen - President & Chief Executive Officer

Thank you. Next question, please?

Operator

Certainly. Our next question is from Tim Race from Deutsche Bank. Please go ahead, sir.

Tim M. Race - Deutsche Bank AG (Broker UK)

Hi, team. Thank you for taking my call. So, maybe if I just break it off with a question on R&D for a second. Just if you could talk about the head-to-head versus Toujeo, what endpoints are you actually trying to prove when you move forward with this? Is it purely about high cost or are you going to show a lower insulin or how do design this to be there?

And maybe part two of that question. Just talk about the oral insulin. What are the decision points that you're waiting for here? And then a question, if I may, on big picture on Lars Rebien's. If you look at your growth profile for this year, probably next year with patent headwinds and maybe even into 2018 with NovoSeven headwinds in competition. You're looking like you're going to be growing mid to high-single digit. Are you not now big pharma given that you spent – that's the growth level you're looking at and also you're spending low-teens on R&D. How do you look forward on your company and what do you need to do to make sure that you were – you continue to grow with higher level in big pharma?

Lars Rebien Sørensen - President & Chief Executive Officer

Thank you very much. Yes. Mads Krogsgaard, a question on R&D, what do you intend to show with the head-to-head story between Toujeo and Tresiba?

Mads Krogsgaard Thomsen - Chief Science Officer & Executive Vice President

Yeah. And the other half question was, of the oral insulin I think both of them – and the first one, I think the Toujeo or the glargine U300 comparison up against insulin degludec shows what we also would've hoped for and expected, mainly this very high degree of – low degree of variability. In the case of insulin degludec with in-patient day-to-day variability and vice versa for insulin glargine U300 that it was several-fold higher and quite exaggerated to kind of in the mid-dosing interval from 6 hours to 18 hours in each dosing interval.

And that tells us that if we do a large trial where we measure obviously eating consumption and we would expect to see a higher potency of insulin degludec molecule confirmed in such a study, we would also expect that we would see reductions in hypoglycemia and that is of course, in particular, in the maintenance phase, because as we all recall, when you use a sub-potent molecule in the titration phase where the algorithm is always that you go up and down by two units only, that is actually only 1.5 unit in the case of glargine U300.

So, in the titration phase, it will take longer to go to target, but of course, you tend to get this high dose because you're hyperglycemic. So, we'll be monitoring in the steady state period, which is everything beyond the first few weeks of treatment. So, it'll be a study beyond 26 weeks, around 2,000 patients, monitoring the overall clinical profile with the aim to achieve superiority.

And then, on the oral insulin, that's a very different story because do bear in mind that when we did all semaglutide in February last year, we had several subsequent updates before management made the phase 3 go decision, and the things here are actually slightly more complicated because in absolute potency terms, you need a lot more insulin than you do of oral semaglutide which I believe is one of the most potent biological molecules in the realm of diabetes.

So, we have those considerations. We also have considerations as to the target product profile, how will this stack up against, for instance, oral GLP-1, which segment should we use it for, is it a way to get early insulinization and what would the target product profile be there versus, for instance, leader injectable insulin degludec and so on? So, a lot of considerations management will have in the time to come and then we'll get back to you in the second half.

Lars Rebien Sørensen - President & Chief Executive Officer

So – thank you very much, Mads. Then on to your much broader and wider question which is whether we are becoming a big pharma, we are, indeed, becoming a big company. But we do think that our business model is slightly different in that we see ourselves as a very focused diabetes care company with a portfolio of interesting based drugs in other areas in biopharmaceuticals.

And you're right. I'm not going to endorse your assessment of top-line growth in 2017 or 2018. But to say that in the last couple of years and likely into 2017 and 2018, we are seeing less than double-digit top-line growth. We have some headwinds, as you say, in the biopharmaceutical area. It's very difficult to differentiate growth hormone. We are seeing new point of entries in the hemophilia space with the – an interesting new concept from Roche. And so, overall, our anticipation is that we would be seeing no support for growth or maybe even a drag from our biopharmaceutical franchise going forward. So, the growth will have to come from our diabetes business. But if we then look at what that is comprising, it is comprising a leading portfolio of insulins, of which we know that there is a phenomenal need everywhere in the world to intensity insulin therapy.

With the faster insulin aspart, we will be rejuvenating our short-acting portfolio with Ryzodeg. We had rejuvenated and better mix product and with Tresiba and with improved label, I think we will be standing in a position two years, three years from now where it's been clear that we have the leading product in the basal segment.

And we also have combos. We can combine Victoza and basal insulins. And there in that class, we also have the best-in-class drug with Xultophy. And then increasingly, we will see in our assessment more support for growth coming from the GLP-1 segment. We see very strong script growth. We see relatively more stable pricing even in some instances, opportunities to raise net prices likely. And if we look at GLP-1 segment come again here in the midterm that you are looking for or come 2018, 2019, then we would be in the situation where we have the best daily injectable GLP-1. We will have the best weekly injectable GLP-1 based on the current results that we see on semaglutide. And we even have right in front of introduction an oral version of that which will open a whole new feel for us being able to compete in the oral space.

And then if you finally add and if we are stretching our definition a little bit and including obesity in sort of diabetes and pre-diabetes, then I still think it is reasonable for us to have as an ambition to grow our diabetes portfolio with 10%. And we see the need is there. And we have the new drugs. And in the current time, we will see some stabilization on pricing. So, I think that is an achievable, desirable ambition for us to retain.

Thank you very much. Next question, please?

Operator

The next question is from Michael Novod from Nordea. Please go ahead, sir.

Michael Novod - Nordea Bank AB (Denmark)

Yeah. Hello. It's Michael from Nordea. Two questions. One is to the gross margin also. Now that you are guiding for declining U.S. price, I know that's into 2017, maybe if you could just provide some overall comments on how we should anticipate the gross margin development to be, whether the pricing effects will be offset by the mix effects or how that would develop.

And then secondly to the GLP-1 franchise. How do you see, and now you mentioned semaglutide, semaglutide mainly going to just cannibalize Victoza and switch patients over there, or do you actually see those are helping you grow the market further, and also can we grow the market share from where you've seen a loss in recent times since they launched?

Lars Rebien Sørensen - President & Chief Executive Officer

Thank you very much, Michael. Jesper, comment on gross margins in 2017, how you see that based on the price picture that we just pouring it out. Any mix effect? Any initiatives on cost or anything like that that will...

Jesper Brandgaard - Chief Financial Officer & Executive Vice President

I mean, the first comment is gross margin this year was – first half is about 20 basis points down. Our guidance for full year still broadly unchanged gross margins. When we look to 2017, in terms of price, it's clear that there will be a negative effect on gross margins. It's also very likely that we'll have a continued positive mix effect that is coming from Victoza, and everything else being equal also a Tresiba over time would be positive. However, for 2017 specifically, do bear in mind that Vagifem in the U.S. is a very high-margin business for us. So, there is unfortunately a negative mix effect coming from Vagifem. So, everything else being equal, it looks like we will have a slight drag on gross margin. But we would prefer to revert to the financial guidance for 2017 when it gets to a line item to our full year results in February.

Lars Rebien Sørensen - President & Chief Executive Officer

Thank you, Jesper. And then, in regards to GLP-1 market anticipation for that, it would be our intention to expand the market. We think that GLP-1 product ought to be used by far more diabetes patient than it currently is. In the future, there will be options for patients to use a daily product or a weekly product. We will have the best-in-class in both of these segments. So, again here, in a way, we would like to create a situation with formulary access, which gives choice to the patients and the physician to choose what they choose. And then, if you go for efficacy, you would probably end up going for the weekly semaglutide. If you go for the very convenient once daily injection, you can go for Victoza. And so, I think we'll be in a very good position to assist in expanding the market and in reality, I think, the market in the future will be a market between Eli Lilly and ourselves.

Lars Rebien Sørensen - President & Chief Executive Officer

Thank you very much. Mads, you have any comment?

Mads Krogsgaard Thomsen - Chief Science Officer & Executive Vice President

Yeah. Just to add that we've, of course, selected to take semaglutide due to its high level of efficacy and use it as a lever into new areas such as non-alcoholic steatohepatitis, NASH, a next-generation obesity compound and so on and so forth. So, sema is predominantly by diabetes but it is clearly also a lever into adjacencies such as NASH such as, well, obesity and obviously also the oral space.

Lars Rebien Sørensen - President & Chief Executive Officer

Thank you, Mads. Yes. Next question, please? Thanks.

Operator

Certainly. Our next question is from Seamus Fernandez from Leerink. Please go ahead.

Seamus Fernandez - Leerink Partners LLC

Thanks very much for the question. Hopefully, you can hear me okay. Just a couple of questions. As we think about the evolution of the gross margin after 2017, I know the product portfolio is changing dramatically, but it seems pretty heavily dependent on semaglutide injection. As you guys have talked about, gross margins for the oral products are likely to be lower in the future. And we're starting to see increasing challenges as it relates to formulary access for products that have incremental benefits, particularly with regard to delivery, things like that. So it just seems like the pressure on the business on a go-forward basis globally is going to be really heavily dependent on volume. And as we think about the evolution of generics and the likely inclusion of multiple biosimilars of insulin, it just seems like the headwinds are intensifying, given the aggressiveness that we're seeing in the U.S. market and with other products being removed globally.

So I'm just trying to get a better sense of the long-term gross margin trajectory rather than just 2017. Can you talk a little bit about that? And then, separately, as we think about Victoza, can you remind us again when Victoza actually will lose its exclusivity in the United States and how you would envision a biosimilar introduction to Victoza evolving the market at that point in time? Thanks a lot.

Lars Rebien Sørensen - President & Chief Executive Officer

Thank you very much. Jesper, a broad question on how you see margin development taking into consideration, the expectation that the orals will have a different composition there by gross margin. And this is, of course, very uncertain because we don't know what pricing is going to be at that point in time. But anyway, give it a go.

Jesper Brandgaard - Chief Financial Officer & Executive Vice President

I think I will refrain from estimating what the gross margin is going to be in 2020 and beyond. I think that, in the current situation, I don't think it's a meaningful estimate to give. But what I do – can give you some kind of feel for is, which I think is more important in saying, where is the gross margin evolving in 18% to 20% range. And I think the thing that is kind of lacking in your view of how our financials are evolving is the constant upgrade that we actually see within the International Operations business where we continuously have been having a high proportion of those sales coming from human insulin and gradually being upgraded to the more advanced modern insulin product, and also actually beginning to see meaningful adoption of the next generation products, and also GLP-1s, which is giving us an inherent mix effect towards the newer products.

And that's not solely dependent on the U.S. But it's apparent that, from your question, that if pricing pressure continues to evolve in the insulin space in the U.S., then there is a drag. And then we have a positive mix effect coming from the new portfolio and we have it from upgrade of patients in emerging markets where we have the predominant number of our outpatients. So, it's going to be a little bit a play between those two factors that's going to evolve over the years. At present, I would see us operate in broadly the same operating margin level, but of course, largely dependent on prices, not solely in the U.S., but also in other emerging markets.

Lars Rebien Sørensen - President & Chief Executive Officer

And with regards to Victoza, you're correct. When we get to the early 20%s, we will see exclusivity on Victoza ending. And that, of course, introduces the potential for biosimilar interest of Victoza. But it also introduces the opportunity to expand the market significantly with – for GLP-1s outside the U.S. in emerging markets where we believe that there's a huge need. But we're – due to price and other considerations, currently, the usage is way too low. So, we'll end up at that point in time with a portfolio like we know it in insulin, with premium products and with more generalized products which will enable us to expand significantly the usage of GLP-1s.

Mads?

Mads Krogsgaard Thomsen - Chief Science Officer & Executive Vice President

Yeah. Just on the patent situation in general, when you – the first to expire is the lira in the U.S. in first half of 2023. But if you look at the other compounds including the degludec franchise, it's 2029. And as you look to sema, it's 2031 and potentially for oral sema, it's 2035, so of course, as a company we have a major interest in getting the most efficacious product to be the mainstream even before that happens, and we have like a five-year period from launch of sema until the patent expiry of Victoza.

Lars Rebien Sørensen - President & Chief Executive Officer

Thank you very much, Mads. Then, ladies and gentlemen, let's have the last question, please?

Operator

Yes. The next question is from Keyur Parekh from Goldman Sachs. Please go ahead.

Keyur Parekh - Goldman Sachs International

Good afternoon and thank you for taking my questions. I have two, please. One last broad picture, given the declining pricing environment in the U.S., if you can help us think about your commitment to continue spending on R&D materially ahead of your diabetes peers. I mean, if Victoza assuming benefit doesn't get reimbursed by Express, does it make sense to invest in a cardiovascular landmark trial for semaglutide, and why? That's question number one.

And secondly, moving away from pricing, what have you learned from launching Tresiba in the U.S. that you think will help you fine-tune the Xultophy launch over the next 6 months to 12 months? Thank you.

Lars Rebien Sørensen - President & Chief Executive Officer

Thank you very much. In terms of spending in R&D, we are of the belief that innovation is the future and that we will be spending ahead of the curve to stay in the lead in terms of being able to introduce innovation. Mads, perhaps, you would like to comment a little bit about how you see the potential for CV benefits. I'm of the opinion that the CV benefits that has been demonstrated on Victoza will eventually also translate into the label and will be meaningful in our discussion about access. I don't necessarily say it will have an impact on price, but it will certainly have an impact on our ability to get access in the future. How do you see semaglutide and are you having intentions to go ahead with a major study in this regard?

Mads Krogsgaard Thomsen - Chief Science Officer & Executive Vice President

Yeah, absolutely so. And Keyur, I think you have to bear in mind two things. One is that the two cost drivers to the health burden of diabetes on society is actually cardiovascular problems where two-thirds die because of that. And then it's the kidney problems, and it does appear as if liraglutide and semaglutide both are doing good things on both of these major target audience for diabetic complications. So, health economically is absolutely important to document that you, in the label can get something that is unique to your product and just seems like lira and to an even greater extent sema is able to achieve that. And just a small anecdote, we're actually spending 12% to 13% on R&D. So, many people would argue that we have a relative modest spend range or appropriate spend range.

Lars Rebien Sørensen - President & Chief Executive Officer

And then, Jakob, so what have we learned with the launch of Tresiba in the United States and how will that influence our ability to launch Xultophy?

Jakob Riis - EVP-China, Pacific & Marketing

Yeah. Briefly, I would say the launch of Tresiba in the U.S. has confirmed that our approach to launching works. As Jesper indicated, we are tracking towards the target of 5%. So, it's going according to plan. Of course, we've learned something all the time. One other thing is that we – the feedback is really good on Tresiba where you could probably be a little more articulate on the coverage. So, that it's evident to the prescribers for which patients they can write the product. And I think we need to be a little vocal. That will probably trigger a lot of questions from your side, then we'll need to deal with that. But in the market space, they need to be very well-informed.

And then we have a situation where Xultophy in the accounts where we have Tresiba covered and that is now on average across the U.S., 71% and for Victoza 86% coverage. So with two very well covered products by the plans which means that we can probably clarify the market access situation for Xultophy since we're already covering the components fairly easily and if we can communicate that clearly, I believe we can take all that has worked with Tresiba into a very targeted and efficient launch for Xultophy, so we promoted where there's access for patients and kind of a wait in places where there's no access point there. On the product side, good feedback on both the individual components we believe also generate some excitement around Xultophy.

Lars Rebien Sørensen - President & Chief Executive Officer

And with that, ladies and gentlemen, we thank you for calling in. And I thank my colleagues for contributing to this investor call. We will be back later in the year with updates as soon as we have them. Thank you.

Operator

Thank you, everyone. Ladies and gentlemen, just to confirm that this now concludes today's conference call. Thank you for your participation. You may now disconnect.

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