Hello, and welcome to the Novo Nordisk A/S conference call. Throughout the call, all participants will be in listen-only mode, and afterwards there will be a question and answer session. Today, I'm pleased to present Karsten Munk Knudsen. Please go ahead with your meeting.
Thank you. Welcome to the Novo Nordisk investor conference call covering the approval of semaglutide 2.4 in the U.S., now known under the brand name of Wegovy. My name is Karsten Munk Knudsen, I'm the CFO of Novo Nordisk, today with me I have EVP of Commercial Strategy and Corporate Affairs, Camilla Sylvest, and EVP of Development, Martin Holst Lange. We'll be doing a brief presentation followed by a Q&A, where we will only do one question per person since we have a fairly short time period today. Today we also might run into forward-looking statements, as you know, by their very nature, these statements are subject to risks and uncertainties, final outcomes might turn out differently. The starting point for the company is our corporate strategy, for our corporate strategy, we have set a set of strategic aspirations towards 2025.
As you see, obesity is a key pillar in our strategic aspirations, both in terms of our commercial execution and growth as well as in our pipeline. For our commercial aspirations, we have set an aspiration of more than doubling our obesity sales by 2025 compared to our 2019 baseline. From a pipeline innovation perspective, we want to continue to develop leading anti-obesity medications for patients on a global scale. With that brief introduction, over to you, Martin, on the clinical trial execution and approval of Wegovy.
Thank you very much, Karsten. As you can see from this slide there, we've been working with some fairly ambitious timelines since the initiation of the development phase III program. We initiated that in Q2 of 2018, and in short succession, recruited for the four pivotal studies that provided the foundation for the regulatory file, finalizing both recruitment and treatment by Q2 of 2020. It's super gratifying to be sitting here approximately one year after with the approval in U.S. and an expected approval with a similarly effective label in December of this year in Europe. Going to the next slide, looking at the label. Obviously, you probably have some time to familiarize yourself with the Wegovy label, but Wegovy is indicated as an adjunct to reduced-caloric diet and increased physical activity for chronic weight management in adults with obesity or overweight.
Obesity as usual being defined as a BMI of over 30, and overweight being defined as a BMI above 27. For the latter, the label stipulates that at least one weight-related comorbidity is required as well. The maintenance dose of Wegovy is going to be 2.4 mg. You want to call out obviously the efficacy stated in the label, where we see weight loss of up to 15%, which is sustained over a period of 68 weeks. The 15% is reflecting the treatment policy estimand, which is when looking at the intent-to-treat population. You previously heard us mention numbers up to 18% of weight loss. This is the trial product estimand where patients are receiving or using the treatment as intended. Basically reflecting the same population, the same studies, but two different ways of looking at the numbers.
You've also seen, we have seen 84% of patients losing more than five percent body weight and 48% losing more than 15% of body weight. It's also possible to look into the label, there's one graph depicting STEP four, showing that as many as 40% are losing as much as 20% body weight after 68 weeks of treatment. Label is also reflecting improvement in cardiovascular risk factors, including lipids as well as hemoglobin A1c. Importantly, Wegovy is not associated with a pre-specified stopping rule. The most common side effects were gastrointestinal side effects, reflecting a standard GLP-1 activating profile. Importantly also, we've been allowed to depict the CV outcome data from SUSTAIN 6. This is obviously reflecting patients suffering from type 2 diabetes, but also reflecting that semaglutide in that space has been shown with a reduced risk of cardiovascular events.
Overall, we are very, very happy with this attractive and strong label, obviously depicting that Wegovy is associated with efficacy that surpasses what has been previously seen in this space, but also with a very, very attractive safety profile. Potentially in type 2 diabetes subjects, also associated with an effective cardiovascular safety profile. We have, going to the next slide, received a number of comments or questions on how sustainable is this. The pivotal development program was 68 weeks. We are super happy to have recently finalized the STEP five program, which is basically investigating 300 subjects with a baseline BMI of 38.5, and being randomized to either Wegovy or placebo. In that space, over a period of two years time, we still see at approximately 17% weight loss, which is sustainable over the full two-year period.
This obviously talking to the very sustainable effect of semaglutide in this space. Still, and I'll remind you of what I just mentioned about the 68 weeks, we still see 40% of patients losing more than 20% of their body weight after the full three years. We also have, in this space, demonstrated semaglutide to have a safe and well-tolerated profile. Importantly, the cardiovascular risk markers still show a similar improvement at the same level as we saw after six - eight weeks, also after two weeks, here reflected in lipid profiles as well as C-reactive protein. Overall, a strong and sustainable efficacy profile, which should leave Camilla with some things to talk about.
Thank you, Martin. Yeah, we are basically ready to launch Wegovy in just three days from now, and that will make it one of the fastest Novo Nordisk launches after approval ever. The uniqueness of obesity in the U.S. market is characterized by huge unmet need. Around 100 million people with obesity are living in the U.S., yet only less than three percent are treated with anti-obesity medication. Wegovy holds the potential to help many more people with obesity that currently do not receive care. The U.S. obesity market has been impacted by COVID-19. Following the lockdowns, there have been impacts to NPRX, as you can see here. However, in the last few months, we have seen a recovery of the anti-obesity market with increased focus on the health consequences of people living with obesity, a debate that has also been sparked during COVID-19.
The launch of Wegovy holds potential to further accelerate the acceptance and use of anti-obesity medication for chronic weight management. We will already, over the coming weeks, build awareness around Wegovy amongst healthcare professionals. We are also working, of course, to make it available to patients in a very short time from now. If we look at the next slide, then you will see that we are also introducing Wegovy in the U.S. at a pack price similar to Saxenda, and we will start the PBM negotiations to secure commercial coverage for this as we speak. Meanwhile, we are launching a U.S. co-pay card for patients of DKK 25 for patients that have commercial AOM coverage.
Based on the unsurpassed efficacy that Martin just showed us, Wegovy will be setting new standards for long-term weight management, and it's also introduced in a single-dose device with an integrated needle. In summary, there is a huge untapped potential in obesity, and the introduction of Wegovy with transformative efficacy holds significant potential to also expand the AOM market. With that, back to you, Karsten.
Thank you, Camilla. Thank you, Martin. Now we open up for Q&A. I remind you that we'll be doing one question per person. Operator, back to you.
Thank you. Just as a reminder, if you do wish to ask a question, please press 01 on your telephone keypad. The first question comes from the line of Martin Parkhøi from Danske Bank. Please go ahead.
Yes, good morning, everybody. Martin Parkhøi from Danske Bank. I think it is for Camilla on the stay time. Could you talk a little bit about what kind of expectations for the stay time that you expect for Wegovy and what assumptions you have included for that in your 2025 aspirations for obesity sales? Also with the stay time, just on the co-pay card, how long time do patients have access to that, given that can they leave treatment even before they have it all through the treatment?
Great. Thank you, Martin. I counted two questions, but Camilla, over to you on stay time assumptions for Wegovy.
What we find very positive about Wegovy is, of course, the data that Martin just showed that shows that in a study of 68 weeks, we see continued weight loss over 60 weeks. This is, of course, what also gives us hope that people with obesity will be treated longer than the average stay time that we see today. We, of course, assume that with Wegovy, we will get increased efficacy, increased weight loss two to three times of what we see with Saxenda. When it comes to stay time, we of course assume that gradually over time will also increase. When it comes to the DKK 25 co-pay card, that will be in place for patients that currently are covered with anti-obesity medication and where the employer has opted in. This is around approximately 40% of patients with Saxenda as it is today.
Of course, while we're offering this co-pay support, we'll be working in the coming months and towards the end of the year, of course, to gradually increase also our access rate with Wegovy. That's the process we are right in the middle of.
Thank you, Camilla. Next question, please.
Next question comes from the line of Jo Walton from Credit Suisse. Please go ahead.
Thank you. Just for clarification, Camilla, can you tell us what the stay time is today on Saxenda, if you think that this could go up two to three times going forwards? Could you just talk a little bit more about your process of getting employers to opt in, because as I understand it, with Saxenda, you had 70% access in the commercial channel, but because of the employer opt-in, it was only effectively 20%. How can you change that, and over what timeframe should we expect that to change significantly?
Yeah.
All right. Please go ahead.
Yeah, sorry, Carsten. I just want to mention that the stay time today with Saxenda in the U.S. is around six months. There are other countries where it's even shorter than that. In the U.S., we expect it to be around that. When I mentioned that two to three times, I was referring to the efficacy of Wegovy on weight loss. That is two to three times that of Saxenda. However, we have of course seen, as I just mentioned in our trials, that we see a continued weight loss beyond 60 weeks with Wegovy. That should be a very positive news to patients living with obesity.
When it comes to opting in, you're right that the gross, so to say, access is somewhat higher than the net access. The net access with Saxenda for where employers have opted in is around 40%, and it's probably more around 70% within the commercial segment when it comes to the gross access. It's really the net access that gives people access to the product without large co-payments. I hope that clarifies.
Good. Thank you, Camilla. Thank you, Jo. Next question, please.
The next question comes from the line of Carsten Lamm-Løntoft from SEB. Please go ahead.
Thank you very much. Let me take this one here. On slide seven, where you talk about the fact that less than three percent of the 100 million patients that are obese are actually treated with anti-obesity medication. Wouldn't that number be significantly different if you also looked at patients that are obese and have type 2 diabetes? I'm sure a lot of the patients here, up to 106 million, they are also treated with some sort of GLP-1 because they already have type 2 diabetes. What would that number be if you include the anti-obesity medication and type 2 diabetes medication?
Thank you for that question there, Martin. Clearly, there is an overlay between type 2 diabetes and obesity. Camilla, it's a relatively low share of patients who are on a GLP-1 in diabetes already, but can you talk to the overlays of patient groups?
There is some overlay of the patient groups. Today, of course, we have around 460 million people living with obesity in general in the world, and 650 million living with obesity. There is some overlap to these populations, but not a complete overlap. Today we see around eight percent of the people treated with diabetes that are being treated with GLP-1s, roughly. There is a slightly higher percentage being treated with GLP-1, but of course, an even higher percentage being treated in general for diabetes. This number, three percent, just reflects that the treatment with anti-obesity medication still is at a very low level compared to the 660 million living with obesity. There is, whether we include people with diabetes or not, a huge unmet need here for treatment of this chronic disease.
Will all the type 2 diabetics convert to Wegovy now that they can actually convert to an effective obesity drug?
There are many people living with obesity that over time, if they will not be treated and their BMI will not be lowered, that they are at risk of developing long-term complications like diabetes, cardiovascular disease, and so on. There are a big number of people living with obesity that are not yet diabetic and not yet being treated. What Wegovy has the potential to do is, of course, to lower their weight loss with up to 17%-18%, and that will significantly reduce their risk of getting diabetes or getting cardiovascular disease.
Thank you, Camilla. Thank you, Carsten. Next question, please.
The next question comes from Sachin Jain from Bank of America. Please go ahead.
Hi there. Thanks for taking my question. Camilla, just to give us some indicators of how you're going to assess launch success in the next six to 12 months. I know you're building this for much longer term, but just any metrics you could give us. Just two questions. One, should we think about launch prescription run rate in the next month, couple of months being above the initial Saxenda launch? Secondly, how do you think the Wegovy launch impacts your Saxenda sales? Is it fair to think that Wegovy layers on top of a stable Saxenda base? Thank you.
Thank you. You know that we have a strategic aspiration to at least double our obesity sales by 2025, and of course, Wegovy is going to contribute to that. Our focus is to start new patients on Wegovy rather than switching patients currently benefiting from Saxenda. Based on the superior efficacy, we think that it's reasonable to assume that many new patients will now be started on Wegovy. There is, of course, a risk of some cannibalization and lower initial value per script while we build the access for Wegovy, but we are really in this for the long-term potential that we just talked about.
You should be seeing us focusing on our measures for getting a strong uptake of Wegovy, expanding the market, and trying to solve the problem for some of all these patients that we just talked about that today are not being treated but are at very high risk of severe chronic diseases if they will not be able to lower their weight over time. Thank you.
Thank you, Camilla. Thank you, Søren. Next question, please.
The next question comes from Michael Novod from Nordea Bank. Please go ahead.
Yeah, thanks a lot. Just a question to the long-term aspiration. Maybe this is to Martin because he's quoted in Danish media during the weekend to say that the outlook for the obesity business is going to change with the launch of Wegovy and also that Novo is foreseeing a doubling of obesity revenues within the next three years. Your original target was that the 2019 sales would be doubled until 2025. Maybe just some comments to this, whether you're sort of changing your communication or whether it's just sort of media chatter, which has been tightened a bit by journalists.
Yeah, thank you for that question, Michael. Just to make it very simple, nothing has changed versus our strategic aspirations. To be very clear, we are saying more than doubling by 2025 compared to a 2019 baseline. No changes there. Clearly, with the approval now and the profile and the trends in the market, we think it's a great time to launch the product. At the same time, we also had a setback linked to COVID-19 compared to when we set our initial target. We believe we're in a good place, and we are very ambitious in terms of rolling out Wegovy as we get approvals and launch into the markets.
Okay, thanks all.
Next question, please.
The next question comes from Michael Leuchten from UBS. Please go ahead.
Thank you for taking my question. Good morning. Just a question on why focus with the copay and access on patients that have insurance and not go for a broader access program whilst you build reimbursement over time? It sounds like you're not doing anything outside a copay program. I'm just wondering why you wouldn't broaden that out? Thank you.
Thank you, Michael Novod. That one's for you also, Camilla Sylvest. Access tactics in the U.S. while we build commercial access.
Yeah. We are, of course, building commercial access as we speak, as we just talked about, and having the copay card in place for patients who have anti-obesity medication coverage already. We are, of course, also looking into broader coverage. As part of our obesity efforts, we are still pursuing broader also Medicare coverage for the longer term with the Treat and Reduce Obesity Act. What is important for us is that over time, longer term, more and more people will gain access to Wegovy, and we believe that with a product with this efficacy, that hopefully over time we will see and be able to build even more access also beyond the commercial segment. This is still for the longer term, and we have not changed our sort of direction with regards to this.
We continue that effort, but right now it's the commercial coverage that is important for us to get in place so that people can get started on Wegovy as we will launch this in just three days from now.
Thank you, Camilla. Thank you, Michael. Next question, please.
The next question comes from the line of Peter Ankersen from Danske Bank. Please go ahead.
Great. Thank you for taking my question and congratulations on approval and good luck in capturing more share. This is on the new 52-week data with diabetes. I have one comment, one question. My comment is that your comment on stay time of six months is the first time I hear such a high number from you, and it's also a high number compared to many of the real-world studies that have been published. I would immediately conclude that you are sort of raising the bar and talking down estimates. That's the comment. My question goes to the bridge from the DKK 5 billion-DKK 6 billion you have today in sales with Ozempic to the DKK 20 billion that is roughly embedded in your company credit consensus by 2027. The bridge comprises of price, stay time, and more patients. Price online was extended, so yes, no impact from price.
Could you give us your splits for the remaining, where you see the split between stay time and new patients coming into treatment, those two components in bridging the gap to 2020 consensus and whether you're comfortable with that number? Thank you very much.
Camilla, if you briefly just comment on the half-life metrics again, and then I'll cover the bridge versus consensus.
Yeah. On the stay time, we have seen a slight increase in stay time in the U.S. over the years, so to say, but it has all along been relatively high in the U.S. compared to other markets. More to the tune of five - six months, whereas, as I mentioned, other places it is maybe more to three - four months. Maybe that just clarifies where we are. Back to you, Karsten
Thanks, Camilla. On the bridge versus consensus, I think the starting point is, I think you should ask your colleagues in the capital markets in terms of how they build their models. It's not for us to comment on consensus. Of course, it's encouraging for us to see, and it's supporting our investment case that other people believe that we have an attractive case in investing in and building this market, and we have an attractive product to do so. Clearly a growth case and again, more than doubling. The question is, of course, more, and we'll execute as good as we can, and then we see how it pan out. We'll be tracking it on a weekly basis. Next question, please.
The next question comes from the line of Wimal Kapadia from Bernstein. Please go ahead.
Great. Thank you very much for taking my question, Wimal from Bernstein. I'll ask Martin a question. Martin, is there any way of identifying the patients that actually demonstrate the most weight loss? I think it's quite interesting that you see 40% of patients maintain greater than or equal to 20% weight loss after two years. Is there any biomarker strategy I know we are working on to really identify these high responders, because for me, that would be quite a strong argument for reimbursement. Just your thoughts there will be interesting.
Thank you, Wimal. Martin, biomarkers and patient segmentation.
Yeah, thank you very much. It's a super relevant question and obviously we are also looking into specifically which patients are losing the most weight and potentially also which will be non-responders. We have both in the STEP program but also in the currently ongoing SELECT study, been collecting bio samples to be able to specifically do this analysis. We already now have a reasonable picture of where we need to look, but far too early to talk about this in detail.
Thank you, Martin. Thank you, Wilma. Next question, please.
The next question comes from the line of Peter Verdult from Citi. Please go ahead.
Morning, Peter at Citi. Just one question for Camilla, please, on access and strategy. Pre-price survey work we did with payers, even assuming parity pricing to Saxenda pointed to them not really changing their openness to provide more access. Just wondering whether you could give any indication as to how near you are to getting the big players on board with Wegovy, and then just on the strategy side, either you're driving patients to seek treatment, you're widening the prescriber base or you're based improving reimbursement access. Are you approaching this very much as a three-pronged strategy or are you pushing harder on one versus the other? Thank you.
Thank you, Peter Verdult. Very relevant question. Camilla Sylvest, our access strategy and what can we say at this point in terms of progress? It's early days since we just got the approval on Friday and then on market development tactics. Which are the main levers to access and pursue in terms of market development?
ank you, Carsten and Pete. Following the approval, of course, right now we are working on the access part. We expect to also have made good progress entering next year. It's really what we're going to put a lot of efforts on for the remainder of this year. Of course, we will update you as we build the access during the year. When it comes to market development, there are really three things that continue to be very important for us. One is the patient awareness that there is help to get, there is treatment to get. You will see us also making sure that our efforts are very much patient-directed much more than they have been in the diabetes space. This is a patient-driven disease to a large extent, as it's not everywhere fully recognized as a chronic disease.
We are also putting a lot of effort on engagement of healthcare professionals and especially those who treat obesity and those who have the potential to do it in the future. That's a big focus of ours also. Finally, of course, on recognizing obesity as a disease and also getting it reimbursed, as we talked about earlier, that is also a main focus for us. Those are really the big levers on our market development that we are focused on.
Thank you.
Thank you, Camilla. Thank you, Pete. We'll take the last and final question.
The last question comes from the line, Richard Vosser from J.P. Morgan. Please go ahead.
Hi. Excuse me. Hi, thanks for taking my question. Just coming back to the commercial insurance that you've achieved for Saxenda, that 40%. Could you give us an idea of how quickly you managed to ramp to the 40% for Saxenda? Whether you think you can go quicker with Wegovy, obviously having built those relationships, whether that could be done in a year or whatever. Just an idea of that timing. Thanks so much.
Yeah. Richard, thanks for that question. Camilla, speed in terms of getting access on the good part where we're standing on the shoulders of Saxenda and have a lot of experiences.
Yeah.
What can you say to speed benchmarks?
Yeah. Of course, the obesity market has developed somewhat since we launched Saxenda many years ago. That's why we expect to make good progress during the remainder of this year with Wegovy and with an efficacy that is two to three times higher. Of course, we also have a good case, so to say, to build also cost effectiveness with this product compared to existing treatments. That's all that we are working on now, and we will of course update you as we build this access. In summary, I think if you keep in mind that we expect to make good progress entering next year, then I think you have an idea about where we're going with this.
Thank you, Camilla. Thank you, Richard. This concludes the Wegovy U.S. approval call. Thank you for the interest. Clearly you can hear that we're very encouraged to have the first approval on Wegovy. We do see a big opportunity in terms of helping patients in the U.S. and later on also on a global scale. We are launching imminently. A lot of urgency on our side. Just a reminder that we're hosting an investor call in conjunction with the ADA later in June. Please book in your calendars accordingly. That will be focusing more on both early and late-stage pipeline activities with Marcus and Martin. Please book that in your calendars. With that, thank you for dialing in and wishing you all a great Monday. Thank you.
This concludes the conference call. Thank you all for attending. You may now disconnect your lines.