Hello, and welcome to the Novo Nordisk AS Conference Call. Throughout the call, all participants will be in
Thank you. Welcome to the Novo Nordisk investor conference call covering the approval of a listen to the commercialization of the company. My name is Karsten Knudsen. I'm the CFO of Novo Nordisk. And Today with me, I have EVP of Commercial Strategy and Corporate Affairs, Camilla Silvest and EVP of a listen only a listen to the presentation, since we have a fairly short time period today.
So today, we a So might run into forward looking statements. And as you know, by the very nature, these statements are subject to risks and uncertainties, and final outcomes a The starting point for The company is our corporate strategy. And for our corporate strategy, we have set a set of strategic aspirations towards 20 a a position in growth as well as in our pipeline. So for our commercial aspirations, we have set an aspiration of more than doubling a listen to our obesity sales by 2025 compared to our 2019 baseline. And a from a pipeline innovation perspective, we want to continue to develop leading a listen for patients on a global scale.
So with that brief instruction, OTU, Martin, on a listen only on the clinical trial execution and approval of Wegovy.
Yes.
Thank you very much, Carsten. So a As you can see from this slide, we've been working with some fairly ambitious time lines since the initiation of the development Phase 3 program. A We initiated that in Q2 of 2018 and in short succession recruited for the 4 pivotal studies a That provided the foundation for the regulatory file, finalizing both recruitment and a by Q2 of 2020. It's super gratifying to be sitting here approximately 1 year after with the approval in U. S.
And a And expected approval with a similarly attractive label in December of this year in Europe. Going to the next a listen only mode. Looking at the label, obviously, you probably have some time to familiarize a listen to the Wegovy label, but Wegovy is indicated as an adjunct to reduce caloric diet and increase a range of physical activity for chronic weight management in adults with obesity or overweight. Obesity as usual being a Defined as a BMI of over 30 or and overweight being defined as a BMI above 27. For a a listen only mode.
The maintenance dose of Wegovy is going to be 2.4 milligram. We want to call out obviously the efficacy stated in a 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 a position to see estimate, which is when looking at the intent to treat population, you previously heard us mention a So basically reflecting the same population, the same studies, but 2 different ways Sorry, 84% of patients losing more than 5% body weight and 48% losing more than 15% a listen to the label. There's one graph depicting step 4 showing that as many a listen as much as 20% body weight after 60 8 weeks of treatment. Label is also reflecting improvement in cardiovascular a risk factors including lipids as well as hemoglobin A1c.
And importantly, we go a position to be in a position to be in a
position to be in a position to be in a position to be in a position to be in a position to be in a position to be in a position to be in a position to be in a position to be in a position to be in a position
to be in a position to be in a position to be in a position to be in a position to be in a position to be in a position to be in a standard GLP-one activating profile. And importantly also, we've been allowed a to depict the CB outcome data from SUSTAIN 6. This is obviously reflecting patients suffering from Type 2 diabetes, but a also reflecting that semaglutide in that space has been shown with a reduced risk of cardiovascular events. A So overall, we are very, very happy with this attractive and strong label. Obviously, depicting that we go a listen only mode.
Thank you. Thank you. Thank you. Thank you. Thank you.
Thank you. Thank you. Thank you. Thank you. Thank you.
Thank you. Thank you. Thank you. Thank you. Thank you.
Thank you. Thank you.
Thank you. Thank you. Thank you. Thank you. Thank you.
Thank you. Our next a safety profile and potentially in type 2 diabetes, Schopex also associated with an attractive a we have, going to the next slide, received a number of comments on a randomized Phase 5 program, which is basically investigating 300 subjects with a baseline BMI of 38.5 a And being randomized to either Wegovy or placebo. In that space, over a period of 2 years' time, we still see an approximately 17% weight loss, which is sustainable over the full 2 a listen only period. This obviously talking to the very sustainable effect of semaglutide a listen only mode. Still, and I'll remind you what I just mentioned about the 68 weeks, we still see 40% of a losing more than 20% of their body weight after the full 3 years.
We also have in this space demonstrated a Semaglutide to have a safe and well tolerated profile. And importantly, the cardiovascular risk markers still show similar improvement at the a similar level as we saw after 6 to 8 weeks, also after 2 weeks, here reflected in lipid profiles as well as C reactive proteins. So a Overall, a strong and sustainable efficacy profile, which should leave Camilla with some things to talk about.
Thank you, a listen. Martin, yes. So we are basically ready to launch we go in just 3 days from now. And that will be make it a 1 of the fastest Novo Nordisk launches after approval ever. The uniqueness of obesity in the U.
S. Market is characterized a range of unmet need and around 100,000,000 people with obesity are living in the U. S. Yet only a listen only mode. Less than 3% are treated with anti obesity medication.
So we go we host the potential to help many more people a listen only mode. Thank you. And following the lockdowns, there has been impacts to NBRx as you can see here. However, in the last few months, we have seen a recovery
a listen
only mode of the anti obesity market with increased focus on the health consequences of people living with obesity, a debate that has also been sparked a listen during COVID-nineteen. So the launch of Bigovy holds potential to further accelerate the acceptance and use of anti obesity a position to be
in a position to be in a position to be in a position to be in a position to be in a position to be in a position to be in a position to be in a position to be in a position to be in a position to be in a position to be in a position to be in a position to be in a position to be in a position to be in a position to be in a position to be in a position to be in
a position to be in a position to be in a position to be in a listen only mode. And if we a look at the next slide, then you will see that we are also introducing Wegovi in the U. S. At a pack price similar to Saxenda, and we will start a listen to the PBM negotiations to secure commercial coverage for this as we speak. Meanwhile, we a we are launching a U.
S. Copay card for patients of USD 25 for patients that have commercial a range of coverage. And based on the unsurpassed efficacy that Martin just showed us, we go we will be setting new a listen only mode for long term weight management and is also introduced in a single dose device with an integrated needle. So a In summary, there is a huge untapped potential in obesity and the introduction of VEGOVI with a positive efficacy, holds significant potential to also expand the AUM market. And with that, back to you, Karsten.
Thank you, Camilla. Thank you, a Thank you, Martin. Now we open up for Q and A, and I remind you that we'll be doing one question per person. So operator, back to you.
Thank
you. The first question comes from the line of Martin Paquoy from Danske Bank. Please go ahead.
Yes. Good morning, everybody. Martin from Danske Bank. And I think it's for Camilla on the stay time. Could a listen.
Could you talk a little bit about what kind of expectations for the stay time you have that you expect for the Gobi and what a You have included for that in your 2025 aspirations for obesity sales. And also with the stay time, just a The copay card, how long does that actually how long do how many long time do patients have access a listen to that given that can they leave treatment even before they have it all through the treatment.
Great. Thank I counted two questions, but Camilla over to you on state time assumptions for Wegovy?
Yes. So what we find very positive about Wegovy is, of course, the data that Martin just showed that a study of 68 weeks, we see continued weight loss over 60 weeks. And this is, of course, what also gives a hope that people with obesity will be treated longer than the average daytime that we see today. So we, of course, a position that we go we will get increased efficacy, increased weight loss 2 to 3 times of what we see with Saxenda. A So when it comes to stay time, we of course assume that that gradually over time will also increase.
When it comes to the a $25 copay card that will be in place for patients that currently are covered with anti obesity medication a and where the employer has opted in. This is around approximately 40% of patients with Saxenda a listen as it is today. And of course, we will be working on while we're offering this co pay support, we will be working in the coming months and towards the end a a listen.
Thank you, Camilla. Thank you. Next question, please.
Next question comes from the line of Jo Walton from Credit Suisse. Please go ahead.
Thank you. Just a clarification, Camilla, can you tell us what the stay time is today on Saxenda, if a listen only if you think that this could go up 2 to 3 times going forward. And then could you just talk a little bit more about a listen to your process of getting employers to opt in because as I understand it with Saxenda, you had 70% access in the commercial channel, a listen only effectively 20%. So how can you change that and over what timeframe should we expect that a range of change significantly.
Yes. So All
right. Please go ahead.
Yes. Sorry, Kat. So just want to mention that the a listen only mode. Today, with Saxenda in the U. S.
Is around 6 months. There are other countries where it's even shorter than that. But in the U. S, we expect it to be around that. So when I a I mentioned that 2 to 3 times, I was referring to the efficacy of Wegovy on weight loss that is a range of 3x that of Saxenda.
However, we have of course seen in our as I just in a listen only mode. We have a very positive news to patients a listen only mode. When it comes to opting in, you're right that the gross, so to say, access is somewhat higher a listen only for the next the net access with Saxenda 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. But it's really the net access that gives people access to the product without large co payments. So I a listen
only mode. The
next question comes from the line of Carsten Lundborg from
Yes. Thank you very much. Let me take this one here. On Slide a 7 where you talk about the fact that less than 3% of the 100,000,000 patients that are obese are actually treated with anti obesity medication. A But wouldn't that number be significantly different if you also looked at patients that are obese and have type 2 diabetes?
Because I'm sure a A lot of the patients here, up to 106,000,000, they are also treated with some sort of GLP-one because they already have type 2 diabetes. So what would that number be if you
a Thank you for that question, Martin. And clearly, we there is no overlay between type 2 diabetes and obesity. So Camilla, it's a relative low share of patients who are on GLP-one in diabetes already, but can you talk to the overlays of the patient groups? A
Yes. So there is some overlay of the patient groups. And today, of course, we have around 460,000,000 people living with obesity in a In general, in the world and 650,000,000 with diabetes, sorry, and 650,000,000 living with obesity. There is some overlap to these populations, but not a complete overlap. And today, we see around 8% of the people treated with diabetes that are being treated with GLP-1s roughly.
And so there is a slightly higher percentage being treated with GLP-one. But there a Of course, an even higher percentage being treated in general for diabetes. So this number 3% just reflects that the treatment with anti obesity a medication still is at a very, very low level compared to the €650,000,000 living with obesity. So there is Whether we include people with diabetes or not, a huge unmet need here for treatment of this chronic a
position. When all the type 2 diabetics convert to VEGOVY
a Living with obesity that are over time, if they will not be treated and the BMI will not be lower, that they a a number of countries that are not yet diabetic and not yet being treated. And the what we go, we have the potential a position to lower their weight loss with up to 17% to 18%, and that will significantly reduce their risk of getting diabetes or getting a look at this.
Thank you, Camilla. Thank you, Carsten. Next question please.
The next question comes from Sachin Jain from Bank of America. A listen.
Hi, there. Thanks for taking my question. As for Camilla, just to give us some indicators of how you're going to assess launch success in the next 6 to 12 months. I know you're building this for a much longer term, but just any metrics you could give us. So just two questions.
1, should we think about launch prescription a listen to the next month, couple of months being above the initial Saxenda launch? And then secondly, how do you think the Regovy launch impacts a Your Saxenda sales, is it fair to think that Vegovy layers on top of a stable Saxenda base? Thank you.
Yes. A Thank you. So you know that we have a strategic aspiration to at least double our obesity sales by 2025. And of course, we go we is a Going to contribute to that. Then our focus is to start new patients on V GoVI rather than switching patients currently benefiting from a listen.
And based on the superior efficacy, we think that it's reasonable to assume that many new patients will a now be started on VIGOVI. 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. So you should be seeing us focusing a listen only mode for the next question. On our
measures to 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 a listen only mode 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, Kjellsson. Next question please.
The next question comes from Michael Novol from Nordea Markets. Listen. Please go ahead.
Yes. Thanks a lot.
Just a question to the long term aspiration. So a listen. 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 clearly going to change with the launch of the Govee and also that Novo is foreseeing a doubling of obesity revenues within the next a listen to the Q1 of 2019 sales should be doubled until 2025. So a 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
a Yes. Thank you for that question, Michael. A Just to make it very simple, nothing has changed versus our strategic aspirations. And to be very clear, we are seeing more than doubling by 2025 compared to a 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, but at the same time, we also had a setback linked to COVID compared to when we set our initial target. A So we believe we're in a good place, and we're very ambitious in terms of rolling out. We go as we get approvals and launch into the markets.
A listen.
Okay. Thanks, sir.
Next question, please.
The next question comes from Michael Leuchten from UBS. Please go ahead.
Oh, Thank you for taking my question. Good morning. Just a question on why focus with the co pay and access a a listen only mode. So it sounds like you're not doing anything outside a co pay program. I just wonder why you wouldn't broaden that out.
Thank you.
Thank you, Michael. That one's for you also, Camilla. Access tactics in the U. S. While we build a Commercial access?
Yes. So we are, of course, building commercial access as we speak, as we just talked about a listen and having the co pay card in place for patients who have anti obesity medication coverage already. We are of course also looking into broader coverage. And 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. So what is a Important for us is that over time longer term more and more people will gain access to Wegovia and we believe that with a product with this efficacy that hopefully over time a We will see and be able to build even more access also beyond the commercial segment.
But this is still for the longer term. And we have not changed our a 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 a place so that people can get started on WeGo as we will launch this in just 3 days from now.
Thank you, Camilla. Thank you, Michael. Next question please.
The next question comes from the line of Peter Seysdel from Handelsbanken. Please go ahead.
Great. Thanks for taking my question and congratulations on the approval and good luck in capturing more share of the 600,000,000 a I have one comment, one question. My comment is that your comment on the stay time of 6 months is the first time I hear such a I conclude that you have you are sort of raising the bar and talking down estimates. That's the comment. My question goes to the bridge From the $5,000,000,000 $6,000,000,000 you have today in sales was extended to the $20,000,000,000 that is roughly embedded in your company related consensus by 2027.
The a The bridge comprises of price, spare time and more patients. Price online with Saxenda, so it's just no impact from a listen. Could you give us your splits for the remaining where you see the split between stay time a 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.
A So Camilla, if you briefly comment on the hard stay time metrics again and then I'll cover the bridge a
consensus. Yes. So 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 a in other places, it is maybe more to 3 to 4 months.
When it comes to a So maybe that just clarifies where we are. And then back to you, Karsten.
Thanks, Camilla. And on the bridge versus consensus, I a 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. So it's not for us to comment a listen only mode on consensus, but of course, it's encouraging for us to see and it's supporting our investment case that other people believe that we have an a competitive case in investing in and building this market, and we have an attractive product to do so. So clearly, a growth case a listen. And again, more than doubling, and then the question is, of course, more.
And we'll execute as good as we can, a And then we see how it pan out. We will 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.
I will mark up with
Wimal Kapadia from Bernstein. A I'll ask Martin a question. So, 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 a 40% of patients maintain greater than or equal to 20% weight loss after 2 years. So is there any biomarker strategy that Nova are working on to really identify a I responded because for me that would be quite a strong argument for reinvestments.
Just your thoughts there will be interesting.
Thank you, Hubert. Martin, biomarkers and patient
a Yes.
Thank you very much. It's a super relevant question. And obviously, we are also looking into specifically which patients a losing the most weight and potentially also which and those of you who will be non responders, we have both in the STEP program, but also in the a currently ongoing select study, been collecting biosamples to be able to specifically do this analysis. A We already now have a reasonable picture of where we need to look, but it's probably too early a
Thank you, Martin. Thank you, Wimal. Next question, please.
The next question comes from the line of Peter Verdult from Citi. Please go ahead.
Yes. Good morning, Peter Verdult, Citi. Just one question for a Camilla, please, on access and strategy. A prior survey where we did with payers, a even assuming parity pricing to Saxenda pointed to them not really changing their openness to provide more access. So just wondering whether you a position to seek treatment, you're widening the prescriber base or you're basing improving reimbursement and access.
Are you approaching this
Thank you, Pete. A Very relevant question. So Camille, 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, so which are the main levers a To access and pursue in terms of market development.
Yes. Thank you, Carsten and Pete. Following the full of course. Right now, we are working on the access part and we expect to also have made good progress entering next a So it's really what we're going to put a lot of efforts on for the remainder of this year. And of course, we will update you as we a 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. So you will see us also making sure that our a very much patient directed much more than they have been in the diabetes space. So this is a patient driven disease to a large extent a listen as it's not everywhere fully recognized as a chronic disease. But we are also putting a lot of efforts a listen only mode.
On engagement of health care professionals and especially those who treat obesity and those who have the potential to do it in the future. A So that's a big focus of ours also. And then finally, of course, on the recognizing obesity as a disease and also getting it reimbursed as we talked about earlier, that is also a main focus for us. So a listen only mode as we talked about earlier. That is also a main focus for us.
So those are really the big levers on our market development that we a
Thank you. Thank you, Camilla. Thank you, Pete. Then we'll take the last and final question.
The Last question comes from the line of Richard Bosser from JPMorgan. 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 a listen for Saxenda and whether you think you can go quicker with Govee, obviously, having built those relationships, a whether that could be done in a year or whatever, just some idea of that timing. Thanks very much.
Yes. So Richard, thanks for that question. So Camilla, speed in terms a Getting access on the good part where we're standing on the shoulders of Saxenda and have a lot of experiences. So what can a Can you say to
speak, benchmarks? Yes. So of course, the obesity market has developed somewhat since we launched Saxenda many years ago, but and that's why we expect to make good progress for the during the remainder of this year with VIGOVI and with an efficacy that is 2 to a 3 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. A So that's all that we are working on now.
And we will, of course, update you as we build this access. A But 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 a listen
only mode. Thank you, Camilla. Thank you, Richard. This concludes the VIGOVI U. S.
A Thank you for the interest. Clearly, you can hear that we're very encouraged to have the first approval on VEGOVY. We do see a big opportunity in terms of helping patients in the U. S. And later on also on a global a listen only mode.
And we are launching imminently. So a lot of urgency on our side. And then just a reminder that we're hosting an investor call in a discussion with ADA later in June. So please book in your calendars accordingly. That will be focusing more on a both early and late stage pipeline activities with Marcus and Martin.
So please book that in your calendars. A Monday. Thank you.
This concludes our conference call. Thank you all for attending. You may now disconnect your lines.