Lars Rebien Sorensen - CEO Mads Krogsgaard Thomsen - Chief Science Officer Jesper Brandgaard - CFO Jakob Riis - EVP, China, Pacific & Marketing Lars Fruergaard Jorgensen - EVP & Chief of Staff.
Sachin Jain - Bank of America Michael Leuchten - Barclays Michael Novod - Nordea Richard Vosser - JPMorgan Tim Race - Deutsche Bank Pete Verdult - Citi Martin Parkhoi - Danske Bank Jo Walton - Credit Suisse.
Thank you. Welcome to this Novo Nordisk Conference Call regarding our performance in the First Nine Months for 2015 and Outlook for the Full Year. I’m Lars Rebien Sorensen, CEO of Novo Nordisk. With me, we have our Chief Financial Officer, Jesper Brandgaard and Mads Krogsgaard Thomsen, our Chief Science Officer.
Also present and available for the Q&A sessions are our Executive Vice President for China, Pacific and Marketing, Jakob Riis; and Lars Fruergaard Jorgensen, Executive Vice President for Corporate Development and Vice Chair of our Operations Committee. Present are also our Investor Relations Officers.
Today’s earnings release and the slides for this call are available on our website, novonordisk.com. The conference call is scheduled to last approximately one hour. As usual, I’ll start with an outline of the presentation as on Slide 2. The Q&A session will begin in about 25 minutes.
Please note that the conference call is being webcast live and a replay will be made available on Novo Nordisk 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 results to differ materially from expectations.
For further information on the risk factors, please see the earnings release and the slides prepared for this presentation. Turn to Slide number 4. Sales growth in the first nine months of 2015 was 23% in Danish Kroner and 9% measured in local currencies. The growth was primarily driven by North America and International Operations.
Sales growth was realized both in diabetes care and biopharmaceuticals with a highest contribution coming from Victoza and Levemir. The rollout of our new generation insulin and especially Tresiba is progressing well. In the first nine months of this year, new generation insulin is accounted for 10% of growth.
Within R&D we announced in late September that the U.S. FDA has granted approval for Tresiba and Ryzodeg 7030 for the treatment of diabetes in adults in United States. Moreover, we have successfully completed SUSTAIN 3, a head-to-head trial comparing once weekly semaglutide with once weekly exenatide in people with type-2 diabetes.
Finally, we’ve completed the second and final Phase 3a study for the use of liraglutide is ADJUNCT TWO insulin therapy in people with type-1 diabetes. Based on these results we do however not expect to file for label extensions for the use of liraglutide in type-1 diabetes.
Turning to the financials, operating profits grew 51% in Danish Kroner when adjusting for the successful partial divestment of IT Services and Consulting Company called NNIT, the growth in operating profit was 16% in local currencies. Diluted earnings per share increased 36% to 10.28 Danish Kroner.
The outlook for 2015 sales growth remains 7% to 9%, whereas the outlook for operating profit growth has increased to around 20% both measured in local currencies. The preliminary outlook for 2016 indicates mid-to-high single-digit sales growth measured in local currencies.
Operating profit growth measured in local currencies is also currently forecasted to increase by mid-to-high single-digit adjusted for the non-recurring partial divestment of NNIT and income related to the out-licensing of assets for inflammatory disorders both in 2015. Turn to the next slide.
In the first nine months of this year, North America accounted for 56% of growth followed by International Operations and Europe accounting for 27% and 8% respectively all measured in local currencies. Sales growth in North America was 33% in Danish Kroner and 10% in local currencies.
Victoza is the largest growth driver aided by high growth in the GLP-1 market. Levemir remains a key growth driver reflecting an underlying volume growth as well as continued market shares gains despite increasing competition in the basal segment in the United States.
Within International Operations, sales grew by 23% in Danish Kroner and by 17% in local currencies. Primary growth drivers in International Operations, was human insulin as we won the large Brazilian human insulin tender.
Moreover, the two modern insulins NovoRapid and NovoMix, and the continued rollout of Tresiba as well as NovoSeven contributed to growth. Sales growth in Region Europe was 4% in Danish Kroner and 3% in local currencies. Growth was driven by Victoza and the penetration of Tresiba as well as positive contribution from NovoRapid and NovoEight.
The European growth is partially offset by contracting premix insulin segment and declining human insulin sales. Furthermore, sales are affected by a negative impact from implementing of pricing reforms in several European countries. In Region China, sales grew 26% in Danish Kroner and 5% in local currencies.
The modest sales growth is driven by continuous market penetration of the three modern insulins, however impacted by intense local competition as well as decline in the growth rates of the overall diabetes care market.
The declining market growth reflects cost containment measures in the healthcare system including restrictions on access to healthcare professionals. Sales in Japan, Korea grew 10% in Danish Kroner and 5% in local currencies.
Growth in Japan and Korea, is driven by Victoza reflecting a positive impact from the improved label in Japan, in September 2014 and by the strong Tresiba uptake. The growth is partially by decline in insulin volumes for the Japanese market. Turn to the next slide.
From a product perspective sales growth was realized within both diabetes care and biopharmaceuticals with the majority of the growth coming from Victoza and modern insulins. Within modern insulin, Levemir is the biggest growth driver, accounted for 19% of total growth in local currencies driven by North America.
Furthermore with the continued rollout of the degludec portfolio new generation insulins contributed 10% of growth in the first nine months. The increase of other diabetes and obesity care reflects a significant positive contribution from the U.S. launch of Saxenda partly offset by declining sales of needles in Europe and North America.
The growth within biopharmaceuticals was primarily driven by Norditropin which grew 10% in local currencies and accounted for 8% of total growth. This growth was primarily derived from North America and reflects favorable pricing and increased demands driven by prefilled FlexPro device.
Haemophilia sales accounted for 5% of the total growth this was primarily driven by the rollout of NovoEight in Europe, Japan and the U.S. as well as NovoSeven in International Operations, partly offset by declining NovoSeven sales in U.S. and Japan. Turn to Slide number 7. Victoza sales increased 39% in Danish Kroner and by 21% in local currencies.
Sales growth was primarily driven by North America and Europe. In North America, Victoza sales increased by 50% in Danish Kroner and by 24% in local currencies. The sales growth reflects our underlying prescription volume growth of more than 15% in the United States.
Despite the recent launch of multiple competing products, Victoza remains the clear market-leader with a prescription volume market share of 59%. Turn to Slide number 8. Levemir grew 27% in Danish Kroner and 10% in local currencies. The growth of Levemir was primarily driven by North America where sales increased 14% in local currencies.
In Japan, sales of Levemir, continues to be negatively impacted by the strong uptake of Tresiba. In United States, growth is driven by the underlying volume growth of the insulin market and the continued market share gain for Levemir.
Despite the launch of a competing product earlier this year, the Levemir volume market share has continued in an upward trend and has reached 24%. Turn to the next slide for an update on the rollout of the degludec portfolio. Tresiba has now been launched in 36 countries.
In Japan, where Tresiba was launched in March 2013, Tresiba has reached 31% of the basal insulin market measured as monthly value market share. Similarly Tresiba has shown solid penetration in other markets with the reimbursement at similar levels to that of insulin glargine.
In the United States, we have started the final preparations for the commercial launch of Tresiba which is planned to take place in the beginning of 2016 while Tresiba soon will be made available to specialists and pharmacies. Xultophy has been launched in Germany, U.K. and Switzerland, and now also in Sweden.
In Switzerland, the first country to launch Xultophy the market penetration measured in value of the long-acting insulin market continues on a trajectory similar to the one achieved with Tresiba.
The positive trend for Xultophy has also led to a slight decline in Tresiba value market share to 26% while our overall value market share in the basal insulin segment continues to increase. Turn to the next for an update on Saxenda in the United States. Saxenda was launched in the U.S.
late April 2015, and the initial uptake is encouraging with Saxenda obtaining 5% volume market share in the total branded anti-obesity prescriptions six months after launch. Market access for anti-obesity medication in the U.S. remains restrictive compared to other therapeutic categories such as diabetes.
This is due to the fact that anti-obesity medication is not covered in the Medicare Part D, leaving access opportunities limited to the commercial channels.
Nonetheless, the level of temporary and contracted coverage that we have been able to secure to date has exceeded our expectation and the level of formulary access for Saxenda has gradually increased to more than 50 million lives are now covered.
Overall launch activities are progressing as planned and feedback received from physicians and patients remains encouraging. With this, over to you Mads for an update on the R&D..
Thank you, Lars. Please turn to Slide 11. On 25, September, the FDA granted U.S. marketing authorization for Tresiba and Ryzodeg 7030 for the treatment of type-1, and 2, diabetes in adults.
Tresiba, the approved brand name for insulin degludec is novel basal insulin with a half-life of 25 hours and the duration of action of at least 42 hours, both related to a unique mechanism of protraction.
Tresiba is indicated to improve glycemia control in adults with diabetes and has based on the characteristics mentioned above, demonstrated a peakless action profile with patient day-to-day variability as low as 20%.
In treat to target studies comparing Tresiba to insulins glargine or detemir, people using Tresiba achieved similar reduction HbA1c with numerically lower fasting plasma glucose observed, despite insulin doses that were numerically lower than the comparator insulin in most cases.
Furthermore, the label states that patients using Tresiba can administer the insulin at any time of day unlike all other basal insulins that must be injected at the same time every day.
Tresiba will be launched in the FlexTouch device in two different strengths, U100 and U200, enabling dosing of up to 80 units and 160 units per injection respectively. Please turn to the next slide.
In September, we announced the results from SUSTAIN 3, the second of six Phase 3a trials for semaglutide, a new GLP-1 analog administered subcutaneously once weekly. The trial investigated the efficacy and safety of 1 milligram semaglutide compared with 2 milligrams of exenatide once weekly in people with type-2 diabetes.
SUSTAIN 3 demonstrated that people treated with 1 milligram semaglutide achieved superior HbA1c reduction of 1.5 percentage points compared to reduction of 0.9% with 2 milligrams exenatide once weekly.
Furthermore, treatment with 1 milligram semaglutide also led to a greater weight loss of 5.6 kilograms compared with 1.9 kilograms for people treated with 2 milligrams of exenatide once weekly. Finally, semaglutide showed a safe and well tolerated profile in the trial. The most common adverse event was nausea which diminished over time.
Discontinuation rates due to adverse events were low, in the high single-digit percent range for both compounds suggesting that classical GLP-1 related gastrointestinal side effects have been reduced through the selected titration scheme. We expect to announce headline results of the four remaining SUSTAIN trials within the next six months.
Please turn to the next slide. In August we announced the headline results from ADJUNCT ONE, the second and final Phase 3a trial with liraglutide as Adjunct therapy to insulin for people with type-1 diabetes.
The ADJUNCT ONE trial investigated the efficacy and safety of daily doses of 0.6 milligram, 1.2 milligram or 1.8 milligrams of liraglutide compared with placebo as adjunct to insulin treatment.
And result showed that people treated with doses of 1.2 milligrams and 1.8 milligrams of liraglutide as Adjunct to insulin therapy achieved an improvement in HbA1c of around 0.5% compared with 0.3% for people treated with placebo as Adjunct to insulin therapy.
Furthermore, people treated with liraglutide doses of 1.2 milligram and 1.8 milligram experienced a weight loss between 3 kilograms and 4 kilograms whereas people treated with placebo as adjunct to insulin experienced a weight gain of 1 kilogram.
In the trial the rate of severe hypoglycemia appeared numerically, but not statistically significantly lower for all doses of liraglutide as adjunct to insulin therapy compared with placebo.
However, unexpectedly, a statistically significant higher rate of confirmed symptomatic hypoglycemia was observed among people treated with liraglutide 1.2 milligrams and 1.8 milligram compared with people treated with placebo.
In summary, the Phase 3a trials documented improved glucose control and weight with a neutral and negative hypoglycemia profile. And hence, we do currently not intend to submit an application to expand the label of liraglutide for use for type-1 diabetes. Please turn to Slide 14.
We also announced that the new drug application for Xultophy has been submitted to the FDA in September. Xultophy is the first once-weekly, once-daily fixed ratio combination of insulin degludec and liraglutide. The submission is expected to be reviewed on the U.S. FDA’s PDUFA V program.
Within short-acting insulin, we completed the additional 26-week treatment period of the Phase 3a trial, ONSET 1, which was undertaken to further evaluate the long-term safety and efficacy of meal-time fast acting insulin aspart.
The results from the additional 26-weel treatment period confirmed the positive results from the initial 26-week treatment period. We expect to submit the fast-acting insulin aspart dossier for regulatory review by the turn of the year. In late August, we announced the decision to progress our once-daily oral formulation of semaglutide into Phase 3a.
The decision is based on the highly encouraging results of the proof of concept Phase 2 trial and the subsequent consultations with the regulatory authorities. The first Phase 3a trial in so called pioneer program is expected to start in the first quarter of 2016.
Within GLP-1, we also initiated a Phase 2 dose-finding trial with the injectible GLP-1 analog semaglutide, administered once daily in type-2 diabetes with the intention to even further improve the glycemic and weight profile of semaglutide.
Within long-acting insulins, we completed the last Phase 1 clinical pharmacology trial investigating the safety, tolerability, as well as pharmacokinetic and dynamic profile of the new once-weekly insulin LAI287.
In a five-week multiple dose trial in type-2 diabetes, LAI287 showed dose-dependent pharmacokinetics and dynamics, and people previously treated with a once-daily basal insulin.
Furthermore, the total variability of LAI287 exposure was low and comparable to that of insulin degludec, with a terminal half-life of 185 hours supporting once-weekly administration. Before initiating further clinical trials, some of the side-effects observed in the Phase 1 trial will be investigated further.
Today, we’ve also announced that we’ve initiated two new clinical programs within obesity. The first study is a Phase 2 dose-finding trial with injectible GLP-1 analog semaglutide administered once-daily for treatment of obesity.
The second study is the first Phase 1 trial with NN9747, a long-acting analog of the endogenous appetite regulating peptide YY. The trial will investigate the safety, tolerability, and pharmacokinetics of single and multiple once-daily doses of NN9747 in around 120 overweight to obese but otherwise healthy people.
Finally, we’ve completed the acquisition of Calibrium and MB2, two privately held biopharmaceutical research companies focused on the discovery of novel biological drug candidates for the treatment of diabetes and related metabolic diseases. With this, over to you Jesper for an update on the financials..
Thank you, Mads. Please turn to Slide 15. During the first nine months, sales increased by 23% measured in Danish Kroner and by 9% in local currencies to 79.1 billion Kroner.
Reported gross margin improved by 180 basis points to 85.4%, this reflects a positive currency impact of 1.8 percentage point as well as a positive impact from the product mix primarily due to increased sales of Victoza, partly countered by non-recurring effects in 2014.
Sales and distribution cost increased by 23% in Danish Kroner and by 9% in local currencies to 20.3 billion Danish Kroner.
The increase is driven by launch costs related to Saxenda and NovoEight, preparation for the Tresiba launch in the U.S., sales force investments in selected countries in International Operations as well as adjustments to legal provisions.
Research and development costs increased by 3% in Danish Kroner and decreased by 8% measured in local currencies to 9.6 billion Kroner. The decline in costs reflects the discontinuation of activities within inflammatory disorders in September 2014 adjusting for the inflammatory disorder costs. R&D costs increased by 10% measured in local currencies.
The underlying increase reflects the progression of the late-stage diabetes care portfolio and is primarily driven by the DEVOTE trial and the Phase 3a program SUSTAIN for semaglutide. The increase in costs is partly offset by lower costs related to the faster-acting insulin as part program following the completion of the program ONSET.
Other operating income net was 3.4 billion Kroner compared to 0.6 billion Danish Kroner in 2014. The increase is driven by the non-recurring proceeds from the Initial Public Offering of NNIT, as well as non-recurring income related to the out-licensing of assets intended for inflammatory disorders.
Operating profit increased by 51% in Danish Kroner and by 26% measured in local currencies to 38.3 billion Kroner. Adjusted for the income related to the partial NNIT divestment, and out-licensing income from the divestment of inflammation assets, the growth in operating profit was 15% in local currencies.
Net financials showed a net loss of around 5.2 billion Kroner compared to a net income of around 400 million Kroner in 2014. The prime part of net financials is the net effect from foreign exchange, which resulted in an expense of 5.1 billion Kroner compared to an income of approximately 400 million Kroner in 2014.
This result reflects losses on foreign exchange hedging contracts especially for the U.S. dollar due to appreciation versus the Danish Kroner compared with the prevailing exchange rate in 2014. Please turn to Slide 16. Overall there was a significant positive impact from currencies and operating profit during the first nine months of 2015.
The development related to the appreciation of all key currencies versus the Danish kroner with the majority of the impact resulting from the significant appreciation of the U.S. dollar. The average U.S. dollar rate for the first nine months of 2015 was 21% higher than the average rate in the first nine months last year.
Similarly the average exchange rate in the first nine months of the year for the Chinese yuan and the British pound were 19% and 11% higher than last year respectively.
The positive impact from key invoicing currencies on operating profit of around 6.5 billion Kroner were to a large degree countered by the loss from foreign hedging contracts which resulted in a foreign exchange loss of 5.1 billion Danish Kroner as previously mentioned. Please turn to the next slide for the financial outlook.
Sales growth for 2015 is still expected to be 7% to 9% measured in local currencies. Given the current level of exchange rate versus the Danish Kroner, the reported sales growth is now expected to be around 13 percentage points higher, equivalent to a sales growth within the range of 20% to 22% reported in Danish Kroner.
Operating profit growth is now expected to be around 20% in local currencies and around 22 percentage points higher for reported growth, equivalent to a growth of approximately 42% reported in Danish Kroner. The expectations for higher level of local currency operating profit growth, is a result of a marginally lower overall cost forecast.
Reflecting the appreciation of the U.S. dollar versus the Danish Kroner, we now expect a net financial loss of around 5.6 billion Kroner. This is associated with losses incurred from foreign exchange hedging contracts and auctions.
This loss will partly offset the growth in reported operating profit and is consequently expected to result in a pretax profit growth rate of around 27%, all of the above assuming the exchange rate for Novo Nordisk key invoicing currencies remains at the current level for the remaining part of 2015.
The effective tax rate for 2015 is reduced by 1 percentage point and is expected to be around 20%, primarily reflecting changes in provision relating to international tax basis. The free cash flow for 2015 is still expected to be between 33 billion Kroner and 35 billion Kroner.
As for 2016, we expect to provide detailed guidance for the year in connection with the release of the full year financial results for 2015 in February. However, in line with historical factors, we do in connection with our Q3 results provide some preliminary guidance for the following calendar year.
Sales for 2016, measured in local currencies are expected to grow by mid-to-high single digits. Operating profit is adjusted for significant non-recurring income elements in 2015, also expected to grow by mid-to-high single-digit percentage point, i.e. an unchanged level of underlying operating margin for 2016.
The non-recurring elements in 2015 relate to the partial divestment of NNIT bringing in income of 2.4 billion Kroner and to the out-licensing income from the divestment of inflammation assets of around 450 million Danish Kroner.
Given the current level of exchange rate versus the Danish Kroner, reported sales and operating profit growth in 2016 is expected to be similar to the growth in local currencies.
The preliminary plans reflect the expectations for continued robust performance of the portfolio of modern insulins Tresiba and Victoza, as well as a positive sales contribution from Saxenda and Xultophy.
Intensifying competition within both diabetes and biopharmaceuticals and challenging market access as well as macroeconomic conditions in China and a number of markets in International Operations, I expect this to partly offset the aforementioned sale drivers.
All of the above expectations are based on the assumption that the global economic environment will not significantly change business conditions for Novo Nordisk during the remaining part of 2015 and especially in 2016. With that, over to Lars, for closing remarks..
Thank you very much, Jesper. And ladies and gentlemen turn to Slide number 18. To summarize, we’re satisfied with the performance in the first nine months of this year. Our key products continue to perform well.
The accelerated GLP-1 market growth contributes to the continued sales growth of Victoza and the uptake of Tresiba, as well as the early feedback on Xultophy and NovoEight and Saxenda are all encouraging.
Last but not least, we’re happy to have successfully passed a number of critical milestones for our late stage diabetes development project particularly the reason U.S. approval of Tresiba and Ryzodeg 7030 and we look forward to the upcoming results for the other R&D projects. We’re now ready to take the first Q&A.
As always I kindly ask all participants to restrain themselves to two questions. Operator, we’re now ready to take the first question..
[Operator Instructions]. We will now take our first question from Sachin Jain from Bank of America. Please go ahead..
Hi. Thanks for taking my questions; two, please. Firstly, just a repeat of a question I asked on the Q2 call, I think, which is could you remind us of your expectations for the long term insulin market growth? Do you remain at roughly 7% volume and 3% price? Obviously the reason for the question is Sanofi have cut their diabetes guidance today.
Lilly are also talking on the third quarter call about slowing insulin market outlook. So, just wondering whether your outlook has changed and, if not, if you could outline why you’re different to competition.
And then secondly, just on Tresiba pricing, again your commentary, the wording has changed a little bit, in my perception, to a small premium to your own products versus a small premium to the broader basal market.
Sanofi guidance again clearly implies price declines over time, which suggests that price premium for Tresiba at launch, could increase with time. How do you think about that on a three to four year view in terms of the price premium increasing? Thank you..
Yes, Sachin Rebien here. Thank you very much for the questions. At the current level our assumptions for the overall insulin market growth is still 5% in volume. And given our portfolio, we expect that we will be gaining share. So the overall model still applies that we’re assuming that we will get 7% volume life.
The value will very much be dependent on the pricing environment, the competitive pressure and pricing reforms. We have previously said that well penetrated, it should look like 3% plus coming from mix and price. This outlook is perhaps somewhat optimistic given the current conditions, so we’ll have to adjust as we go along.
But overall expectations for market growth 5% in volume, Novo Nordisk beating the market growth with market share gains and 7% is pretty good guess in that regard. Then in regard to the price of Tresiba in the United States, we have picked a price that we know which is Levemir and then we have added the premium to Levemir.
In fact, we have added a 10% premium to Levemir. In the future of course our pricing strategies will be and our rebating strategies will be dependent on where competition will be moving with their prices. And so, we’ll have to take into consideration that in reality, what the payers are looking at is the net price, that’s list price minus rebates.
And we’ll have to adjust accordingly should the current pricing environment become more tough..
Can I just take on follow on? The plus 3% pricing historically, in your mind, does that have potential to go negative for you as well?.
I think that we will be getting some mix effects because we have a new portfolio that we are introducing. So we will be replacing some of the old human insulins as well as the modern insulins that we know of today, Levemir and NovoMix. But it’s a little bit too early to state.
And I think I prefer that we discuss this perhaps a little bit more detail when we get with the long-term financial targets, because obviously we will be making some assumptions for the mid-to-longer term when we update you on those..
Thank you..
You’re welcome. Next please..
We will now take the next question from Michael Leuchten from Barclays. Please go ahead..
Thank you. Two questions; one similar to Sachin’s question. On the Sanofi change to their guidance clearly implies somewhat has changed. And the one thing that may or may not be a driver of that is clearly the arrival of a biosimilar in Europe, rest of world. We do see a healthy uptake of that biosimilar in Japan, for example.
So, question to you, how do you see the environment change at all in the basal space where that biosimilar is available, please? And the second question, on the contract you’ve lost or you’re going to lose in the U.S. from January, I’m just wondering if you could add some color on that.
Was that a decision not to participate because the pricing went too low, or did you bid and you just ended up losing the contract? Any color you would shed on that would be helpful. Thank you..
Yes, thank you very much. Of course it’s a little bit difficult for me to guide you on what’s included in Sanofi’s mid-term outlook for the insulin market.
I think I mean, the only thing that one can speculate on is of course that Sanofi’s basal franchise is under pressure from two sides, under pressure from the launch of an innovative premium product Tresiba, and the launch of a biosimilar Abasaglar.
So, obviously, this is putting pressure on their pricing and their volume growth expectations going forward. In regards to contract loss, this was a deliberate decision on our part not to buy that contract at the price that we would have to accent because we felt that it was a very aggressive pricing.
This is a significant contract but we do win some and we lose some every year. But this one will have some market share point volume impact on us. But on the other hand it was at a very low price, so the profit impact will be less.
In Japan, I would perhaps defer the question of the success of the biosimilar Lantus’ Abasaglar to Jakob Riis to comment on since this is his area of expertise..
No, I’ll follow-on on your comments. I think when you compare what Sanofi has been out with and us, you could say, we talk about Sanofi being pressured on both sides. So, part of it coming from what Tresiba delivers. So when we look at our situations, Tresiba is of course as positive so we can add that in.
And we would as we’ve stated before say that biosimilar competition, the biosimilar versions of glargine up against Lantus is more a dynamic within the glargine area and has limited impact, direct impact on our current sales of Levemir, where that takes place.
And I’ve said, on top of that, where we are then in a position where we can promote Tresiba with sort of further withdraw ourselves from that dynamic. So not that you can say it has no impact, but it’s much-much less than when you sit and are getting squeezed from two sides as is the case for others..
Japan..
Thank you..
This was the general comment that also applies to Japan, so that’s why we had Tresiba and limited impact on the biosimilar supply..
All right, okay, good. Next question please..
Next question comes from Michael Novod from Nordea. Please go ahead..
Hello. It’s Michael Novod from Nordea; also two questions. One is regarding the rollout of Xultophy. You’ve received the positive opinion in Scotland.
Do you expect to see that the average price of Xultophy is going to be in that ballpark, around 38 Kroner to 40 Kroner per day, and then that you will see a general positive reimbursement environment for Xultophy in Europe compared to Tresiba, where it has been very negative? And then, the second thing regarding China, you see continued problems in China.
You also guide down on ‘16. Maybe you could just provide a bit more color on what should change this.
Is it only market dynamics, or is it also in general just a broader use of locally produced products?.
Yes, this is Lars here. I’ll just give you a just one overall comment on China, and then I’ll ask Jakob Riis to discuss where he expects pricing in excess for Xultophy to look in Europe based on the positive opinion from SMC. In regards to China, we are impacted by increasing local competition.
And we are impacted by a segment shift, much like we have historically experienced the same in Japan, where we have a strong position in premix market, China used to be a premix market. Now basal market is growing. The competition has the gold standard and local competition has a copy of the gold standard.
And that means we get fewer patient when the patient shift for mix to basal. And so, we are being hit by that. The only real solution to this is of course that we get Tresiba into the Chinese market, so that is a couple of years out. So, I think we will be facing relatively tough market conditions in China for a couple of years.
But Jakob, if you have further comments Jakob on China, which is also your responsibility and then talk a little bit about the rollout of Xultophy in Europe and your expectations for that? And please..
Yes. So, now just on China, that you’re right, some of the segment dynamics are little bit against us. We have filed Tresiba for approval in China, so it’s on its way. And the volume growth is still good albeit a little bit in the segments where we’re not so strong.
So we do believe that the pricing impact we have ahead of us that at some point, the volume debt will normalize and the volume effects of the vast under-treatment of the Chinese diabetes population will be a positive factor again. So, we hope China, we expect China to come back. But here in the immediate future, we expect lower growth.
Xultophy in Europe, correct, we have positive opinions out of Scottish Medical Consortium.
And at a price point as mentioned up in the 30 Danish Kroner for daily treatment, whether that will be accepted widely is another question, you could say we are also faced with dynamics in for instance in Germany, where we are struggling to have them even accept to look at the data because they do not accept the comparatives.
I would say, my view is that Xultophy is such a good product and if we can get an acceptance at that price point, we have a possibility also in Europe in the near-to-medium term to get Xultophy into a number of the European market and accepted.
It is exceptionally high value from a clinical point of view, so we’re in a good position to hopefully come to an agreement on what prices should be reimbursed. But it will be small incremental steps here in the beginning.
We believe in the value so we’re not willing to sort of you could say, not have the full value of innovation of Xultophy acknowledged..
Okay, thank you very much. Next question please..
Next question comes from Richard Vosser from JPMorgan. Please go ahead..
Hi. Thanks for taking my questions. Two, please; first one on the Tresiba ramp in the U.S.
Could you give us some idea of the dynamics we should play through on that, and specifically how you’re thinking about 180 day block for Medicare Part D, whether you think that applies and how you can potentially negotiate that in a faster way? And then second question, just some more detail would be nice on the long new long-acting insulin, weekly insulin, 287, just those side effects.
If you could give us some more color what they are, that would be great. Thank you very much..
Thank you Richard, this is Lars here first. And then I’ll hand over to Mads for a comment on LAI287. Well, you should expect a relatively slow ramp of Tresiba in United States. We are not currently going to pursue an aggressive access strategy for our party.
And hence, I think I also mentioned this in my introduction to this call that we are primarily going to go after the commercial market initially. We think Tresiba offers value to the patients and to the healthcare professional. And therefore we want to price that to the extent that we can. We are not in a panic.
We are going to be in diabetes many years into the future. And it is befitting and it is beneficial for us to try to retain the segment value as opposed to short-term cutting price. So, very gradual penetration, most like you have seen in the past.
What is different though, I would say is that whereas in the past, we would normally guide you in the new products, we basically get a part of the new stocks on insulin.
In this case, we think the value of the product, the clinical value of the product is such that we are expecting to get sort of half the patients coming from new starts and then the other half coming from already insulin treated patients.
And therefore there will be some cannibalization of our own Levemir patients but not to the extent that we expect to see Levemir decline. But however the growth of Levemir will be stunted as we penetrate the market.
But if Lantus has the lion’s share of basal market in the United States, our anticipation is that as switches goes, it will be primarily Lantus patients that would be switching to Tresiba.
With that, Mads, what are you seeing on the weekly insulin?.
Yes, so the once-weekly insulin LAI287, you can say we have few subjects because it’s only a Phase 1 program.
What is the product per say or molecule is an insulin analog that has been designed with the backbone and the side chain to give a rather unique mechanism of protraction so that it actually circulates in the body with a half-life, terminal half-life of 185 hours.
And the issue is that when you have so few subjects as you do in this kind of Phase 1 program, you always obviously see side-effects/adverse event. And when we report to you we don’t have the full picture.
So rather than go into detail with such small numbers, I’d rather say that it’s very natural that you do look into the side-effects that you have seen, investigate those maximally and then you can make a decision as to progression into your Phase 2. So, I won’t be more specific than that at this point.
But obviously as the program hopefully continues into further development, then we can start being more specific once you’re in the Phase 2 mode. Phase 1 is limited patient exposure..
But, Mads, could you perhaps, sort of more in a general term, elaborate little bit about what are the conversations we have with key opinion leaders. I mean, I recall that when we started the introduction of Tresiba, there were some concern on the part of some key opinion leaders, the duration of action, would that prohibit adjustment of therapy.
And so, this must be exacerbated with the once-weekly insulin..
That’s another thing we need to discuss Lars because clearly the kind of, you can say hesitation on behalf of clinical investigators when we, and I personally attended some Phase 2, pre-Phase 2 investigator meetings where there was a lot of hesitation as to how can we titrate this insulin without running the risk of hypoglycemia and when do we get to steady state.
These discussions we are indeed having albeit at a higher level with this one.
When that is said though, I was personally surprised when I saw the results that we went up against the best instinct in the game which is insulin degludec, and we actually saw that the peak to trough and the overall ability actually was reminiscent of that which we achieved with once-daily degludec.
However, the titration issue remains because with half-life of more than one week, obviously the time to steady state and when you can start titrating does become something we need to consider before a Phase 2 program..
So, it is a paradigm shift?.
Yes..
All right. Thank you very much. Thank you very much. Next question please..
Next question comes from Tim Race from Deutsche Bank. Please go ahead..
Hi there, gentlemen. I suppose a couple of questions just on the R&D side of things, and protection longer term. Looking at the daily semaglutide, obviously it’s a number of years before it gets to the market.
But, can you just talk about the thought process in terms of a daily semaglutide versus what is Victoza in a relatively competitive sort of sub segment of the GLP-1 space? Is this biosimilar protection, or just a better product and you want to sort of up your game again? And then, just a few thoughts perhaps on NovoSeven.
Just what happens to this product post potentially the ACE 9/10 and various other elements entering this market? Do you have any thoughts in terms of what we should be expecting for long term growth of the product and how fast the competition could impact it? Thank you..
Thank you very much. Mads, I guess most of this is, is in your ballpark. And I can perhaps pitch in as it goes to growth expectations for NovoSeven going forward..
Of course, Lars. So, the idea about once-daily sema arose from two sides of the equation, one being that we do know that Victoza is today’s best product in the market and that’s also witnessed by how we perform.
But when that is said, the data we’ve seen on semaglutide so far justifies the hypothesis that semaglutide puts us even more intrinsic efficacy for reasons that we can always discuss.
Now, since we do have some peak to value fluctuation after once weekly dosing, we can go down to a peak to value fluctuation within 1 percentage point, plus or minus one percentage point if we administer the molecule on a once-daily basis that will mean two things that we have even more exquisite coverage at even more peripheral target tissue receptor levels.
And also that the peak related GI side-effects that GLP-1 can be associated with should be reduced. So the notion is that we believe as a company that there will be in the long-term future market for all GLP-1 for once-daily GLP-1 and for once-weekly GLP-1 and believe it or not, we’re even looking into a once-monthly GLP-1.
And to cater for the best possible needs of the patients, we do that to tweak out whatever benefit we can using such treatment paradigm..
But Mads, it is clear that we do believe that semaglutide as a molecule is more powerful than Victoza, especially on the weight side..
Especially on the weight side Lars. And the trick here is, that using cutting the weekly dose into seven daily doses, we’re actually striving to go even beyond the efficacy that you know from the once-weekly 1 milligram semaglutide..
Yes.
All right, then, describe a little bit how you see ACE 9/10, where will that fit into treatment of hemophilia and then perhaps we can sort of work our way into how is that going to impact NovoSeven?.
Yes, I think I must admit, it’s too early to speculate. The early data from ACE 9/10 are obviously looking encouraging as we all know.
But you do need to see a more sustained data in greater patient populations before you can really see what is the true efficacy level of this agent because quite frankly it’s a prophylactic agent because it has a long half-life in it’s given sub-cut once a week.
I do not know the exact on demand efficacy of this agent and you do get in mind that unlike ACE 9/10, NovoSeven is actually not a prophylactic agent because of the short half-life. It’s an on-demand agent. So, how exactly that interplay will occur, I cannot project at this point.
Unlike with the Factor VIII where you can say Factor VIII is used, both prophylactically and on-demand, there is ACE 9/10 of course is up against the fact that Factor VIII is replacement therapy and patients are happy and well treated on that. Some might be more conservative in terms of going to a whole new kind of chemistry.
But again, the data so far is encouraging, it does represent a new paradigm, but I simply am not inside full enough to speculate on the commercial side..
So, this is basically also where we are at the moment we’d like to see some further data and the profile of ACE 9/10. But clearly it is a very interesting concept and it is so interesting that we are working on our own, almost similar concept as you should talk a little bit out on concizumab..
Yes. So we’re working on actually, on many bypassing concepts that are for subcutaneous administration. The most advanced of them is the TFPI blocking antibody, concizumab, that has just entered into multiple dose studies in hemophilia A patients. And as you correctly say Lars, it’s just a different way of bypassing the need for Factor VIII.
And the case of concizumab, you can actually also bypass the need for Factor IX of that Factor VII. So, if we make it with this one, it will indeed by a more universal hemostatic agent for these congenital bleeding disorders..
Thank you. But in conclusion, now obviously if we do not develop any new drugs and ACE 9/10 is having a phenomenal profile, it will have a negative impact on our franchise, that’s very clear. Thanks. Next question please..
Next question comes from Peter Verdult from Citi. Please go ahead..
Yes, good afternoon. It’s Pete here from Citigroup. Two questions, the first one, yes, for Lars. We’re obviously seeing two contrasting diabetes outlooks from you and your friends in Paris today. Just with that in mind, my question relates to the U.S. basal insulin market dynamics longer term.
I mean, to date it’s all been about co-preferred contracting rather than competitors going for exclusivity, I’m just interested in your thoughts and whether you think exclusivity becomes part of the game in U.S.
basal post 2016, and whether the pricing strategy you’ve elucidated over the last few quarters on Tresiba remains valid if the switch study fails to show a hypo benefit. And then, on Mads, just wanted to get an update on your thoughts heading into Leader, we’ve seen the CV benefit with empagliflozin.
It’s postulated to be driven by a diuretic effect, which Victoza doesn’t have. So, I wanted to understand whether you’re optimism of previous quarters has changed in light of EMPA-REG. Thanks..
Thank you very much Peter. I’ll give you at least a couple of sense worth on the U.S. basal market. It is clear that that U.S.
market will undergo some tremendous transition next year with the advent of Tresiba now, with the advent late next year on Abasaglar, with the advent of LixiLan, which - we don’t know of course how Sanofi has got a position in LixiLan. But I would imagine they don’t go off head-to-head against Xultophy, which will be launched at the same time.
Because there we have, we are certain that we can, we have a much, much better profile. So, in a way they have the option of positioning this as a better basal also. So there is going to be a lot of traffic, our surprising strategy will remain as it is until we see competitive actions. And this means basically that we think we are pro-choice.
And we think there are big parts of the market in the U.S. and especially that we are targeting initially, in the initial phases that are interested in choice. So, but it’s anybody’s guess what will happen post ‘16 and into ‘17, when the market gets crowded.
And if some of the competitors are not successful of getting market penetration and access, then anything can happen.
The court is clear on the buy side that some of them would like to build exclusive contracts to drive off rebates other insurance companies prefer to have different plans with choice that they market to employers that are willing to offer this to their employees. So I think it’s a very complex situation to forecast.
Our pricing strategy remains and the moment the market condition dictates us to take a change, we will inform you.
Then Mads?.
Yes. And if I may, I know it’s not my prerogative to talk about commercial things, but if I may just interject one comment. You do have to bear in mind that the exclusive positions that some of the parental insulins have in the U.S. market is because they’re basically the same.
But you cannot claim that Tresiba and detemir and the glargines are the same. So these are truly different choices, just if I may..
Yes, sure, sure..
Give some scientific remark. But when we look at interesting question about Leader, it’s really good news for the patients and also for our friends at Lilly and Boehringer Ingelheim that they have these data on empagliflozin. But you can argue it does reduce the likelihood of the Leader trial coming out positive for couple of reasons.
One is that now history tells us that it can be done, to actually achieve a CB benefit as we’ve just seen at the ASD meeting.
The other is that this has nothing to do with the disease pathology because the way that, at least as I read it, because the way the curves out initially from the get go in the trial, tell me that as you also stated more like a diuretic effect or something.
And the interesting thing is of course is, what if you load up all patients with maximum doses of thiazide diuretics, which do have a cardiovascular benefit, would you then still see the benefit of the impact, and so and so forth, many questions remain to be answered.
And my view is that it’s more interesting to have an agent that if it can interfere in the vessel wall pathology due to both the glycemic and the dyslipidemic and the hypertensive, you can say, maladies that are ongoing in the type-2 diabetic body, then that would be a long term investment for the patient because you would get the legacy or the memory effect of the drug that once was used unlike a diuretic which works when it’s given and then it stops working after it’s given the last time.
So, I think Peter, this on the one hand will go hand-in-hand, so if we show good data then there will actually be additive to those of impact, which is also good news for the patient. But my hope is that we have something where there remains a legacy effect potentially years after people have encountered Victoza..
Thank you, Mads. And then switch or not switch data, our current pricing strategy, it’s based on the current label. And this means switch can, if switch are positive that is also an opportunity to raise the price. It’s not only going in one direction, we should remember.
So but let’s have the data and then we can chat about that when we talk together the next time or after Q1. Thanks, next question please..
We will now take the next question from Martin Parkhoi from Danske Bank..
Hello. Martin Parkhoi, Danske Bank; two questions, firstly regarding your expectations for Victoza in 2016 given that you are now putting all your sales force over on Tresiba. And that if we look back in history we saw in 2011 you saw quite weak insulin growth, which I guess one of the reasons was due to the high focus on the Victoza launch.
Could we risk to see a similar impact on Victoza next year? We also see that Lilly have started that there. We did see a campaign just recently. And then, my second question is actually also regarding Victoza.
And do you believe that some of the positive growth we have seen in Victoza over the last six to eight months has something to do with the approval of Saxenda in obesity, given that, due to the low formulary access on Saxenda, then there has been higher prescribing on Victoza? So, that would also change when the formulary access increases on Saxenda?.
Thank you very much Martin. In regards to giving guidance on individual products for next year, we prefer not. What we can say about Victoza, you are of course right that there will be a period of time where there will be full force on Tresiba. And then we will revert to the current structure that we have. In the U.S.
we will all along in 2016 have a specialized sales force on Saxenda. This is something we do to avoid cross-promotion and avoid compliance risk. So, we believe there will be solid growth in the GLP-1 market. And we of course hope that this strength of the gold standard in this market, Victoza will remain after a short detour to promote Tresiba.
It is of course also sure that when the fourth is detailing Tresiba, they have second detail will be Victoza for many of the reps so, it’s not like it’s completely out of the market. Second question, I don’t think that there is a link between the approval of Saxenda and the growth in the marketplace.
I think we can detect the growth coming all the way back to the time when FDA and EMA eradicated the lingering concern on pancreatic safety after the bottler paper. So, we believe that that is the key driver. And then also of course that there are more companies out there, out in the street talking about the virtues of the GLP-1’s therapy.
And so these are the main factors as far as we’ve seen.
Mads, have you any comment?.
No, I agree Lars..
Okay. Last question please..
We will now take our last question from Del Drudge from Credit Suisse. Please go ahead..
Hello. It’s Jo Walton from Credit Suisse. Two quick questions, please. If we look at the IMS data, the total IMS data, we do see Novo still gaining some share versus Sanofi.
But, if we look at the new to brand data in IMS, there seems to be the reverse situation where certainly, since the launch of Tresiba, the new to brand seems to be moving in Sanofi’s favor.
Is this just the usual inconsistencies of IMS and the fact that they’re missing some important contracts so it’s not giving us the right story? And secondly, just looking at Xultophy, I’m wondering where you think this will be positioned first.
Do you think this is the sort of drug that people will take when they’ve failed orals before they move to insulin so this is like a first line treatment? But, that would obviously be a very expensive treatment.
Or, would you expect it more to be reserved to people who’ve moved from the orals, they’ve tried the insulin, that hasn’t been good enough, and then they’re going to a combination therapy, which of course could then perhaps justify an even greater premium price? I’m just trying to think of where you primarily see the positioning of that molecule?.
Thank you very much, Jo. Lars here, I would defer both questions actually to Jakob Riis, the first on how does it look between total scripts, us gaining share and NBRx in the basal segment..
Yes, always when we compare NBRx and up against shares and so on, it’s they are both highly correlated. Whether you could always make their math work out completely is another question, that’s sometimes not possible. When you have a launch of a new product, you will see of course the NBRx impacted initially.
And so short-term you’ll see a large movement that it will take a while before that plays into the actual market share. So, this is what we’ve seen in many other launches and what we expect.
So we would still expect that the impact trajectory to be modest but of course there will be one, but it will not be as dramatic as you might read it into the first sort of weeks or months of NBRx data.
And to confuse matters, of course when we launch Xultophy in certain markets they will see a dampening also of the NBRx in the basal segment because some clinicians use Xultophy as a better basal. And so that impacts. So in a way you should look at Tresiba plus Xultophy in one combination.
Having said that, then our positioning of Xultophy dose asking for how do you see that being positioned, but it is clearly positioned as an intensification of basal patients because they’re already on an injectible, on insulin. They’re measuring their blood glucose.
All of these transitioning into Xultophy, will give them a better A1c, a weight lowering without additional injections and a very low risk of hypoglycemia relative to being on pure insulin. So it’s a very, very strong value proposition there.
Over time, it is likely we will see some clinicians starting patients off after orals on Xultophy because they believe that an interim step on insulin will not be worth it and they can go straight to Xultophy. But initially it’s going to be from the pool of uncontrolled patients on basal insulin. And that’s also our positioning.
But, that is bound to change over the next, you could say five years. But this is where we start..
Thank you very much Jakob. Thank you very much ladies and gentlemen. Thank you very much my colleagues. We will be back with the annual result in the beginning of next year. Over and out from us..