Novo Nordisk CEO And SVP On Ozempic And Wegovy

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Following is the unofficial transcript of a CNBC interview with Novo Nordisk A/S (NYSE:NVO) CEO Lars Fruergaard Jørgensen, Novo Nordisk A/S Global Drug Discovery SVP Karin Conde-Knape and CNBC’s Meg Tirrell during CNBC’s “Healthy Returns Summit: Moonshots to Miracles” today, Wednesday, March 29th.

Interview With Novo Nordisk CEO And Global Drug Discovery SVP

MEG TIRRELL: Well, good morning to you both. I’m so excited to get to talk with you. You know, Lars, let’s start with you in sort of thinking about this moment for Novo Nordisk. You’re a 100-year-old company, with, of course, your roots in diabetes.

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And now we're at this moment when you have this new class of medicines for both diabetes and obesity that many are calling a potential revolution in the way we treat these conditions. Maybe just talk about this moment with your drugs Ozempic and Wegovy and what you see the impact of them and future medicines really having on these diseases.

LARS FRUERGAARD JØGENSEN: Yeah, good Morning. Meg, thanks for having us. Yeah, this is a truly amazing period in the history of Novo Nordisk. And I would also say, for people living with both diabetes and obesity.

As you know, we have 100-year legacy in insulins and during the last couple of decades, we have researched a lot into the new category called GLP-1 that was first tested out in Type 2 diabetes. And during that process, we, we realized that it had a quite broad biological mechanism that also lends itself for being tested out in obesity.

And we're now seeing for the first time really efficacious anti-obesity medicines that really meeting the expectations of both physicians and patients in terms of weight loss. And as obesity is a leading cause of Type 2 diabetes and a number of other diseases, you can say that we're actually going to prevent one of the diseases we have been living from from from many years.

And the fact that alone in the U.S., there are at least three times as many people living with obesity compared to people living with with diabetes, this is a significant opportunity for improving health of the individual, increasing health resilience, taking burden off healthcare systems, and obviously also an opportunity for a company like Novo Nordisk.

So we're really excited about what we seeing in the market and what we're bringing to patients these days.

MEG TIRRELL: And Karin, maybe walk us through some of the science behind these medicines. This class of drugs, people feel like they kind of came out of nowhere, but they really didn't, right? I mean, there were earlier iterations of drugs in this class, and they've sort of gotten better over time.

Maybe explain the science behind them, how do they work? And why is this latest group in this class having such an impact?

KARIN CONDE-KNAPE: Yes, thank you Meg, but maybe if you allow me, let's just take a step back and then just cover a brief recap as to what are the drivers of obesity? Well, at least as what we understand today, and it's important to say that obesity is in very simple terms, a combination of what energy that you intake, and then the energy that you use, right.

So it's that balance that is quite important to have it in good in good shape. Now, it's also important to remind us that about 70% of the population that lives with obesity has a genetic component that is driving the disease, but also an environmental factor, right.

So if we can come back to the balance of energy in and energy out, this is where this mechanism of the GLP-1 plays a role. Now, the control of energy intake is actually a very complex system that is mainly modulated in the brain. And now we have more understanding as to what are the areas of the brain that are actually playing a role here.

So the GLP-1 that is secreted from the intestine signals through the brain in the specific areas that actually control how much hunger we have, but also how full we feel after we have a meal. And in individuals that maybe are suffering more with obesity.

There is a deregulation in this level of proteins or peptides and therefore we are providing an additional component by modulating the GLP-1 natural hormone so that it can last longer in circulation and have a more durable effect.

So this is actually quite different from the previous mechanisms, mainly because of a direct effect on on the satiety so how much hunger that we have, but also because it has additional elements in terms of controlling what is the type of food that we are craving for so tackling a different part of the brain that also signals through the sensations of satisfaction when you eat certain type of foods. You can read more about this subject here.

MEG TIRRELL: And Lars, maybe talk about this moment for the company, have you ever had a medicine that's had this kind of cultural impact? You know, Ozempic, and Wegovy are basically household names at this point. There were jokes at the Oscars about how everybody was taking one of these medicines.

WeightWatchers has now gotten into this space because they saw it as a space they had to be in because this is so important to the category of weight loss. How does that cultural moment, how do you think about that as as the company? Have you ever been in a situation like this before with a product?

LARS FRUERGAARD JØGENSEN: Well, it's important for me to underline that Ozempic is approved for Type 2 diabetes, and Wegovy is approved for obesity and is now launched on the U.S. market. But your point about what it actually means for patients is a really, really good point because if you live with obesity, you typically live with obesity for a good part of your life, if not your whole life.

And many have tried all kinds of different attempts to lose weight. And to Karin’s point from before that there’s genetic element for most patients, it's really important to acknowledge that this is actually a serious chronic condition to live with and many of those who reduce energy intake.

The body will actually also reduce energy expenditure to maintain what is your, your BMI, so to say, so it's really really difficult to to in a sustainable way lose weight.

So now we have these medicines that in, in a good way, is bringing both the weight loss that patients are looking for and bringing it in a sustained manner for quite a long period of time. And this is great and brings a lot of hope.

And if you have been controlled by by your hunger, you know, getting your say life back and and actually being able to focus on on other things is really, really a defining thing for for one of these patients.

So I'm really, I'm really excited about that. And what we as a company can bring to patients and empower those patients to live say a full enriched life and contribute to society. So, in my view, this medical intervention is going to want, be one of those that has the biggest say benefit for the individual but also for society compared to what we typically see of medical interventions.

MEG TIRRELL: And Karin, maybe tell us a little bit about the experience for people taking what go Wegovy. Let’s talk about the weight loss they see. You have to keep taking the drug in order for the weight to stay off. Is that right?

What does the company know about that? And what also do you know about if you're taking this drug, you know, chronically, does your weight keep falling or at some point do you reach a stasis? How does that work?

KARIN CONDE-KNAPE: Yes, thank you. So I think again, we need to come back to what is that we know in this balance of energy in energy out and Lars was alluding to the body is trying to fight right? If you are controlling the amount of food that you have, your your food intake is also going, sorry your energy intake is always going to change as well as your expenditure.

So what we know today and this is both based on animal pharmacology as well as the clinical trials is that you do need to keep taking the medicine because what GLP-1 is doing is again still controlling your your satiety, but it's not yet let's say redefining your neural networks to really define a new body weight setpoint.

And I think this is what we see when people go on diets or different exercise regimens, similar to when they go on pharmacological treatment, that as long as you're keeping your your intake the same, your output the same and you're able to control your weight.

But if you go out of this, you will immediately start to come back and for different individuals this period of stay with your weight loss or your weight stable will be very different. Some will come back earlier some will come later.

But what is critically important is that definitely you need to stay and this is again something that we both in pharmacology, animal experimentation as well as clinical data. So quite critical because we are not yet able to redefine that body weight setpoint that that's where the next generation of investigation and and trials will help us understand much better.

MEG TIRRELL: Oh yeah, I would definitely want to ask you about that sort of next generation of medicines as well. But just sticking on this point, what has been observed about, you know, how much weight patients would gain back if and when they stopped taking the medicine? Do they gain back all of the weight they lost on average? Do they gain back more? Did they gain back less?

KARIN CONDE-KNAPE: I think it's the data that we have, again, varies really, depending on the individual, but in about, you know, five years or so, you're about to recover almost all your weight and maybe in two to three years about 50%.

But this again is a very different rate of gain depending on the individual. So the reality again, just to stress out that you need to keep controlling your intake and your expenditure and the the pharmacology that we have today, the pharmacotherapies are actually helping us do that in a way to control the signals to the brain.

So it is important and it's very difficult to say for one individual today how soon you will be able to come back or how soon your bodyweight will really go back to the starting point. And in some other instances, some individuals actually go beyond the initial starting point. So again, some of the work that we need to understand what drives the rate of return into your original bodyweight.

MEG TIRRELL: And kind of just sticking with you for a minute, I think one question a lot of people have for a medicine that you would need to take chronically and I've seen comparisons to Statins, for example, you stay on these for long periods of time to maintain lowered cholesterol.

Similarly, you know, sticking with what Wegovy for long term weight loss, keeping the weight down, what is known about the long-term safety of taking these medicines for years on end?

KARIN CONDE-KNAPE: So right now, the data that we are generating is, you know, two years, three years, I think is the maximum that we have at the moment. And so far, we can say that the drugs are well tolerated, there is no safety that we are aware of, we continue to monitor this.

So for the time being for the duration of data that we have, people maintain their weight. You were asking as to how much more do they get there is a time where you get the plateau.

So I think all things considered right now with the data looks that it's tolerable, the safety profile continues to be favorable as well and the weight loss is maintained and still we'll need to see how much more with the longer duration of treatment how much more will people will be able to achieve.

But right now, it's about the, you know, 20% weight loss for about 30% of the population on on the treatment. So quite favorable compared to other treatments in the past.

MEG TIRRELL: And what are the some of the the long-term risks that you're especially looking out for potentially to see, you know, we hear about the risk of pancreatitis or a risk that was seen in animals of a certain type of cancer. What are the sort of things you are looking out for, for the long term safety?

KARIN CONDE-KNAPE: As certain, we continue to monitor the individuals are exposed to the to the treatment. And so far, the data that we have today does not suggest that there is any concern that we need to worry. Of course, we keep monitoring. So you know, we keep just looking for for patients and that's all.

MEG TIRRELL: Well Lars, tell us about the access to these medicines, you know, we know that they were in shortage for a period of time. What does the supply look like now and what does the reimbursement environment look like where patients are having their insurers actually pay for these drugs for them?

LARS FRUERGAARD JØGENSEN: Yeah, you're right. When we launched initially, we saw a very, very strong demand, much stronger than we have seen in in prior launches. Then we ran into some challenges with a contract manufacturer, and they had to hold manufacturing for a period of time.

That meant that we could not support the market with the starter doses, but we kept supplying the maintenance, maintenance doses because they came from a different facility. Then we are back in the market.

We have, you know, built inventories to be able to relaunch we did that in the beginning of this year. We see a very strong uptick. We have two more manufacturing lines being prepared to come in line during this year.

So we're very encouraged to see the uptick and we keep investing, we have guided for significant, significantly higher CapEx investments, some three and a half billion U.S. dollars on yearly basis for for some years.

In terms of access, we have a market structure in the U.S. where it's primarily commercial insurance so employers opting in for obesity support for the employee base and a couple of say government channels so we can address approximately 40 million people living with obesity in the U.S. out of the say 110 million having a BMI of 30 and above and will greatly expand that access.

So this is actually a sizable access compared to also what we know of people living with Type 2 diabetes. So it's a similar market, we can we can address already at this point of time, and it will keep being expanded, expanded in the future.

And it's still only, you know, a very small fraction of those who live maybe 2 or 3% of those who live with obesity who are actually on on treatment today. So there's a lot to focus on in our commercial organization, and and they are having very good traction so far.

MEG TIRRELL: And one thing I know that Wall Street is watching very closely is a study that's expected to read out I believe this summer looking at the cardiovascular outcomes of using a drug to lower weight.

So, you know, we know that using a drug for people who have diabetes can result in lower cardiovascular risk things like heart attacks, but for people who don't have diabetes and are using the drug for obesity and losing weight, what is the impact then on preventing heart attacks and other cardiovascular risk events? Lars, how important is that study for Novo Nordisk and potentially securing more reimbursement from insurers?

LARS FRUERGAARD JØGENSEN: Yeah, that's a great question, we know that, Ozempic, the product for Type 2 diabetes in obesity, sorry the Type 2 diabetes has proven to reduce the risk of cardiovascular disease by 26%, very sizable risk reduction. And I mentioned that the uptick so far of the obesity producer Wegovy is very, very strong.

So we can say that it is taking up the demand is there even despite the fact that we do not have these CV data for Wegovy yet.

As we look to broaden the market and also look to secure market access reimbursement in say European markets where typically a single payer, and it's government funded healthcare, it's important to show that this is actually something that's improving health, it’s not just reducing weight for the individual.

And the benefit that comes from that was also having a positive impact on on say overall health resilience. So we believe it will, it'll be a part of the puzzle in getting broad reimbursement.

But I’ll just underlying that so far the markets we have launched Wegovy in, which is only three markets, it's a U.S. obviously it's Denmark, Norway, we see very steep uptick in all markets. So for sure there is a demand, even without the CV component. But we think it's important for the longer-term build of say healthcare system based reimbursed based access to obesity medicine.

MEG TIRRELL: And Karin, what are the next steps here? I mean, you guys are continuing to test next generation medicines, combinations. What do you see as sort of the next leg forward in this class of medicines in terms of, you know, weight loss, Type 2 diabetes, the outcomes you expect to be able to achieve?

One thing we've heard from doctors is that it would really be great if the tolerability were improved with these because you can feel some kind of nausea and GI effects from these medicines. What will the next step look like?

KARIN CONDE-KNAPE: Yes, Meg and thank you. And first and foremost, coming back to that energy, energy balance, it is important to understand that the brain regulation of energy intake and output is actually quite complex. So right now, we have very good results with the GLP-1 based medicines, but there is room for providing an additional mechanism that will help add more benefit.

So at the moment, we are exploring actually a combination with another peptide that brings additional components to the satiety element, but also into that reward system that we all have when we eat again different types of foods and an additional component as well as the energy expenditure.

So this additional mechanism is based on Amylin, and Amylin is a peptide that is secreted out of the pancreas at the same time of insulin when you have for food consumption, this peptide signals as well in the brain, but in slightly different regions where the GLP-1 signals and by doing this.

This is where you're adding additional mechanisms that will work together to deliver much efficacious weight loss, and potentially as well, you know, we'll need to explore if it's going to be more better duration and and stay down on the weight.

So the moment we are exploring this, we have generated another analog that it's also have a longer lasting activity. And we are combining this Amylin analog with the GLP-1. And we have so far a very interesting data in phase two where we are achieving about 15% weight loss in Type 2 diabetic patients.

So we are very excited about this particular combination. But you know, the quest in identifying better mechanisms for obesity is not over yet. We need to do still much more research in order to understand additional drivers of disease because as I alluded to, despite the fact that we are able to achieve very nice weight loss, that sustainability and that weight maintenance it's quite important.

 

And then also, we still have room compared to what we can achieve, for example, with bariatric surgery of about 30%. So mechanisms that will help us drive that weight loss further.

But beyond weight loss, you were alluding already about cardiovascular protection, we believe that we need to start driving as well for understanding how these weight loss is going to help protect another comorbidities, cardiovascular disease being one of them.

So exploring mechanisms that will potentially protect additional organs, in addition to bringing weight loss to the to the individuals. So it's quite exciting times. But there is still a lot of work for us to do.

And I think it's an important time as well science wise because as we are starting to deliver mechanisms that are achieving significant weight loss, there is there is more excitement in the community, not only at the level of universities or investigators but also the level of biotech that there is more interest because now we can show that this is possible.

Right, that you can achieve significant weight loss and then over hopefully that the data that has been generated in the past in terms of complication prevention that this will be solidified and therefore really engage more interest and more innovation will come in this space from Novo Nordisk but from others in the field as well.

MEG TIRRELL: Really the beginning of a potential revolution here and Lars, to end our conversation, I think we'll go back to where we began and that's, of course, with the origins of the company in insulin, you recently announced that you plan to lower the list price of your insulin following a similar move from Eli Lilly.

What was the driver for this? There was some reporting that in addition to the demand from patients and lawmakers for there to be lower prices, you actually would avoid a Medicaid penalty by lowering the list price of the drug. Did that drive the decision?

LARS FRUERGAARD JØGENSEN: Well, if you follow the history of Novo Nordisk, you have seen that we have put different attempts out to make insulin affordable, and this is, say, the next round of those efforts acknowledging that many patients are struggling because of insurance scheme design.

And by this change, we lower the list price is what is what many patients end up paying. Your, your comment on on all aspects I'll just say that the complexity of the U.S. market is one where it takes many, you know, different options to really make insulin affordable for patients and that's what this is all aimed at.

MEG TIRRELL: All right, Lars, Karin, thanks so much for a fascinating conversation. We really appreciate it.

LARS FRUERGAARD JØGENSEN: Thank you for having us.

KARIN CONDE-KNAPE: Thank you.