Lexicon Pharmaceuticals, Inc. (LXRX) Earnings Call Transcript & Summary

Good morning, everyone. Welcome back to the 4th JPMorgan Healthcare Conference. I'm Jial, and I work with senior analyst, Jessica Fye, in the team. And we have the pleasure of having the management team from Lexicon Pharmaceuticals joining us for today's discussion, including CEO, Lonnel Coats. So big thank you to you guys. And I'm going to hand over the Zoom to you and come back during the Q&A section. Lonnel.

Jial, thank you so very much. We really appreciate the opportunity to present how we're progressing forward here at Lexicon. As always, I'd like to start these presentations off by thanking all the extraordinary men and women here in Lexicon who work tirelessly every day to advance our science into the hands of patients. With that today, on Slide 2, I will be making forward-looking statements. Some of those statements will contain risk. Our risks are outlined in our SEC filings. So let me jump right in on to Slide 3. This is really a transformative year for Lexicon and our stakeholders because we have 2 really remarkable events that I really want to focus on during this call. Number one, we're very pleased to say that sotagliflozin heart failure NDA was submitted. Should we be successful in terms of the label that we're seeking, it will be a very unique label for recent and worsening heart failure for patients with type 2 diabetes. We know that sotagliflozin will be entering into a multibillion-dollar double-digit growth overall heart failure market. And if we are successful in the strategy, we have for approaching the market, we believe sotagliflozin has peak blockbuster potential. We expect to launch sotagliflozin in the second half of this year if it is approved. We're very, very fortunate that also out of the laboratories of Lexicon is LX9211 for neuropathic pain. We have 2 Phase II studies that are advancing, and we will have data and call out on those 2 studies in the first half of this year. Should we be successful, we know the neuropathic pain market is also a multibillion-dollar market. And as far as we're concerned, it remains an unsatisfied market. LX9211 is a remarkably novel target and an innovative approach for treating neuropathic pain. If we have clinical success here, it too has the blockbuster potential, as I spoke about earlier. So these are the 2 remarkable assets of Lexicon that could be very transformative this year for our company. Let me start off by talking a little bit about that there is truly a new dawn rising as we get into this next slide in the area of heart failure. So let me share some numbers with you as you go to Slide 5. There truly is an opportunity for sotagliflozin in an emerging and fast-growing heart failure market. When you look at prevalence, there's somewhere around 6.2 million people in the United States with heart failure. And that number is growing. There's about 1 million new heart failure cases annually in the United States. The proportion of these patients who have type 2 diabetes is 44% and greater, and that number is growing. So we have a growing and emerging market that I believe sotagliflozin will address. Secondly, the unique label that I talk about, and you're going to hear me speak to this quite a bit in this presentation, is worsening heart failure. It represents a particular opportunity for sotagliflozin because in our SOLOIST trial, the data from that is very compelling, and sotagliflozin will be the only drug that has studied patients for registration and worsening heart failure. Heart failure, as we know, is the #1 cause of hospitalizations for Americans older than 65. The unique thing here is that 25% of patients that are discharged from the hospital end up back in the hospital in 30 days. 65% of patients are readmitted to the hospital within a year. And sadly and unfortunately, 50% of patients die within 5 years of diagnosis. So recent and worsening heart failure is a significant issue. When we think about cardiovascular diseases, we think about high blood pressure, we can think about lipid-lowering agents. All of these things are quiet conditions that contribute to overall cardiovascular issues. And so it takes a lot of effort to convince patients to go on medications, it takes a lot of efforts to inform and educate physicians. For chronic heart failure, it's very different because patients feel their condition on a daily basis. You can look at things from shortness of breath. That's the number 1 thing that patients with chronic heart failure reports. People change their life because they can no longer do the chores that they normally do on a daily basis just because they just don't have the energy as a result of their condition. So patients are highly engaged in their care. If you go to Slide 8. When I said there's a rising new dawn, it's because when we look at the remarkable data that has come from the SGLT class in the area of heart failure, the guidelines are going to shift and they're going to change. And we're very pleased to see that the European Society for Cardiology recently added SGLTs to the standard of care for heart failure. The ESC recommends that all 4 of the categories be used to combat chronic heart failure. Very pleased to see SGLTs added to it. But what makes it so remarkable is that when you look at conventional sequencing. And this is a slide that was put together by Dr. Packer and McMurray when those guidelines came out. They looked at conventional sequencing and said, "Well, step 1 is that you start a patient off with ACE and ARB and then maybe 6 months later, you evaluate and you start with -- you then add on a beta blocker, you evaluate again and then you add on the MRA, you evaluate again and you maybe add on an ARNI. And at the very low end of that option is an SGLT2. I will say that ARNI is where ENTRESTO plays and is moving towards a $3 billion global product. Now with the new guidelines, when you think about the need to address heart failure immediately, it is recommended the first step is beta blockers of SGLT2s. So you're really moving SGLT2s from being a massive part of the market into, quite frankly, being the first amount of care of intervention. So that is what changes the dynamics quite significantly and increasing the opportunity. So even before the ESC changed these guidelines and made its recommendations, global data looked at the remarkable data that was coming from the SGLT class and made a projection. And that is that the chronic heart failure market will go from $3.7 billion in 2018 and projected to be somewhere over $22 billion as you get into 2028 in terms of worldwide gross sales. That represents over a 19% CAGR. So it's not Lexicon saying that this is going to be a remarkably growing market. It is very clear that others believe that this will indeed be remarkably growing market. When we look at segments where there could be a great opportunity for sotagliflozin to play, if you look at Slide 11. Well, ESC looked at all 5 of the SGLTs and certainly made a recommendation that they all should be recommended for primary prevention of heart failure. We agree. They then also looked at the data from 3 of the SGLTs have done work and have [ route ] with patients with diabetes, and they've recommended 3. We are one of those 3. What's remarkable about that is that of those 3, sotagliflozin is the only one that have yet to be registered or approved, giving great credence to the strong evidence that we have shown in the clinic. But further to that, the ESC recognized that sotagliflozin was the one drug that also show benefit in worsening heart failure. This is a tremendous complement to all the extraordinary work that we put into the SOLOIST program that I'll share with you shortly. Now when we think about heart failure, we know that patients with heart failure will have a chronic decline over time of cardiac function. And where most of the drugs that have studied, heart failure is in this chronic population. It is patients who have risk for chronic decline, you intervene early to try to prevent that risk. And all the SGLTs that the ESC has looked at and others have looked at, quite frankly, are showing some pretty good results. Where we looked at this further is in these dips. These dips represent a patient who becomes an acute decompensated patient and requires hospitalization. The patient typically becomes severely short of breath and incapacitated with fluid buildup giving a sense of drought. And at that point, intervention is critically important, and this is where we studied patients with our SOLOIST study, which I'll share with you later. Now why is this important? It's important because when we look at the heart failure cost burn to the U.S. health care system, it is projected to go from $43 billion in 2020 to rise to almost $70 billion in 2030. That is a 60% forecasted increase. 80% of that cost in total heart failure costs are related to hospitalizations. Now 2% to 3% of the cost are drug costs. It is important if you can find an innovative product that can address heart failure or prevent chronic heart failure or intervene where there is a recent worsening heart failure, you could begin to bring down some of these costs. Further to that point, we look very acutely at the hospital, and we thought about where is the most likely intervention point for patients, particularly worsening heart failure is the hospital. What was most interesting when we looked at what happens when they go into therapy, whether it's beta blockers, RNAs or MRAs, the most interesting finding here is that when a patient is started in the hospital and you look at them 60 to 90 days out, they're refilling their prescription. When you look 12 months out, you still have a very high percent of patients refilling prescriptions. When that prescription takes place outside the hospital, you have a very different story. So having a key intervention point with an innovative product in the hospital, particularly for patients with worsening heart failure, creates a remarkable opportunity for a program like sotagliflozin that have shown tremendous benefit. So I've talked about sotagliflozin and tremendous benefits. So let's talk about the differentiation and why we have so much confidence that in the hospital setting where recent and worsening heart failure takes place, it gives sotagliflozin uniqueness. Let's first start with 2 well-controlled outcome studies, both of which were published in the New England Journal of Medicine. One is SOLOIST, which was studied for patients and diabetes with recent worsening heart failure, and the other one was SCORED that was studied in patients with diabetes and chronic kidney disease. So if we go back to my graphic that I shared with you earlier, we know that patients with chronic heart failure are going to have a steady decline in cardiac function. And what you want to do is study these patients that when you have early intervention where they have these risk factors to try to bring down the risk. That's what we studied SCORED is in that chronic population. That is also where other SGLTs have studied patients. What makes sotagliflozin so remarkably unique is that we took the risk of studying patients who were having an acute decompensated event in a hospital setting with the SOLOIST study. So we got the chronic and we looked at the acute. So what did we find? So this is an important slide to share with you because when you look on the vertical axis, these events per 100 patients and then certainly on a horizontal axis is over time. And so what you can see here is that on average, patients had 1 event over an 18-month period. This is important because the patients that were in the SOLOIST study were heavily treated on standard of care. As you can see to the right, patients who were on loop diuretics, beta blockers, ACE inhibitors, ARBs, ARNIs, MRAs, and still, you had patients who were having events. Now when you add sotagliflozin on top of the standard of care, which is pretty much what ESC is recommending, here's what you see. You see a significant relative risk reduction and a number of events. And we talk about absolute risk reduction, we're talking about 28 events being reduced out of 100 patients. Why is that important? That's 28 fewer patients in the hospital, 28 fewer patients that are burdening the health care system and has 28 fewer patients who are going through the significance of a recent and worsening heart failure event. This is remarkable data that is going to be critical when we roll out sotagliflozin in the marketplace for hospitals, payers because I think we're all going to be aligned on the opportunity to bring down cost as a result of the study. Equally important, when you look at the p value is 0.0009, highly statistically significant, great study and great results from SOLOIST. Now we're not done. Not only do you get a significant magnitude of difference, but that difference happens in 28 days. Remember, 25% of patients, when they are discharged from the hospital from an event, they return within 30 days. So having an impact within 20 days is also a critical factor for the determining of rehospitalizations, which is again an opportunity to work with hospitals and institutions to interject care with sotagliflozin and also have the opportunity to potentially reduce costs. We're not done. Let's talk about the SCORED study. SCORED study had the same outcome, but you -- excuse me, same primary outcome measurement. But you're looking at a different population, you're looking at a chronic population. You can see that based on the events per 100 patients. And even there, we saw a 26% risk reduction, which is very consistent with what we saw with SOLOIST in the acute setting. So whether it's the acute setting or the chronic setting, you saw a significant risk reduction with sotagliflozin. We're not done. Also in the SCORED study, for the first time, you have an SGLT that has shown remarkable results in both MI and stroke. There was a 32% reduction in fatal or nonfatal myocardial infarction and a 34% risk reduction in fatal or nonfatal stroke. We believe that these results are being seen because we have a unique mechanism with the SGLT1 that's been added and the emerging evidence that it does indeed play a role in cardiovascular health. And we believe this is why you see this outcome with the sotagliflozin in the SCORED program that you may not have seen with other SGLTs. Equally important, when we talk a lot about heart failure, we end up talking about left ventricular ejection fraction, and that determines if a patient has reduced ejection fraction or if the patient has preserved ejection fraction. Here's what's pretty cool about when you look at the SOLOIST and SCORED data combined. It does not matter if the patient has an ejection fraction less than 40 or if a patient has ejection fraction greater than 50, whether they're called reduce or whether they're called preserved. Sotagliflozin worked across the entire spectrum of left ventricular ejection fraction. And that, my friends, is a remarkable result that we hope to ensure it makes it into the label because we think it will be defining and differentiated. Now let's talk a little bit about the Lexicon opportunity and how we think about commercializing this opportunity. So if you go to Slide 25, I'm going to go back to some metrics, right? We know that this is an emerging and fast-growing heart failure market. Heart failure is the number 1 cause of hospitalizations for Americans older than 65. You have about 1 million hospitalizations for heart failure annually in the U.S., particularly recent and worsening heart failure, which is an incredible intervention point for a new therapeutic. And you have 44% of those patients who will have type 2 diabetes, and that number is growing. Equally important of why I wanted to share with you is that when you look at preserved injection fraction that has been difficult to diagnose, difficult to treat and very few treatment options, actually over time, unfortunately, preserved ejection fraction is making up a bigger and bigger portion of patients who show up with heart failure. This is important because you go back to the chart I shared with you earlier. Regardless of ejection fraction, whether it's called reduce or if it's called preserved, sotagliflozin works. That should give physicians great confidence that when they intervene with sotagliflozin, they have a great likelihood that they're going to get the result as intended. As we think about commercialization and we look at prescriptions in the marketplace and the weigh our patients, remember, we're talking about patients who are in the Medicare population. So when you look at the heat map, it will not be surprising that you will see a great concentration of heart failure patients in large centers where there's also a very high Medicare population. When we go further and look at the prescriptions, we believe that 60% of the prescriptions over time has come from about 8,000 cardiologists. So the patients are concentrated and the prescriptions are concentrated. So when we took a look at it and thought about it, well, we can compete with anybody in that space. One, we're going to have the data, and we're going to be the only one with the data with recent and worsening heart failure should we be successful in our indication. Two, you can only rotate on 8,000 physicians so many times, no matter if you have 300 reps or 1,000 reps. We think we can compete in this segment with anybody because we do have the differentiating data. And more importantly, the relative value of going beyond that 6% isn't as high for us to spend the cost and resources to try to do that. So we're limiting our efforts in that 6% category, and we're going to punch up above our weight because we have the uniqueness in our -- we should have the uniqueness in our label based on the work that I shared with you earlier. If we do that and we do that well, I'm very confident to say that sotagliflozin overtime will become a blockbuster drug. Now for me, it gives me great excitement to not just talk about sotagliflozin entering into a multibillion-dollar market and potentially becoming a blockbuster drug, how cool is it that not just that innovation from Lexicon. But there's a second innovation that she will be successful with it clinically will also go into one of the largest markets in the world, and that's neuropathic pain. Now the neuropathic pain market is in great need of new innovation, and we hope to solve that. It is a $13 billion market globally with a 13% projected CAGR over the next 5, 6 years, about 12 million people worldwide with diabetic peripheral neuropathic pain and about [ 600 ] patients worldwide with postherpetic neuralgia. So what's the problem? The current therapies are limited by a lack of efficacy, side effects and potential for abuse. Well, we hope that LX9211 is going to solve some of that. Well, what is LX9211? It is a potent, highly selective oral small molecule inhibitor of adaptive protein 2 associated kinase, better known as AAK1. Lexicon is proud to be -- to have been the discoverer of AAK1 in alliance and a collaboration and discovery with Bristol Myers Squibb. We're proud to have the sole rights for this compound, and we're proud to have moved it all the way into the clinic. As a result of some of the preclinical findings, we now have Fast Track Designation for LX9211 for diabatic peripheral neuropathic pain. When we look at the preclinical models, it demonstrated excellent CNS penetration. We saw reductions in pain behavior in multiple preclinical models. And then we looked at single and multi-dose Phase I studies is important once daily dosing with a favorable clinical safety profile. Headache and dizziness was the most reported events. So what do we have? We have an innovative approach to treat neuropathic pain without the addictive potential and potential with some of the other potentiating facts that we see with gabapentinoid. So what have we done? We have 2 Phase II double-blind studies that are in the clinic now. One is the DPNP study that I talked about earlier that has Fast Track Designation by the FDA. It's a 3-arm study, placebo and then a 100-milligram loading dose followed by a 10-milligram daily dose and then a 200-milligram loading dose followed by a 20-milligram daily dose. The primary endpoint has changed from baseline to week 6 in the average daily pain score. Approximately 300 patients are being enrolled in this study with over 40 U.S. sites participating. The study is ongoing, and we are feeling very confident that our stakeholders are going to know the results of this study in the first half of 2022. Let me move on to the financials. We ended the third quarter with $120 million in cash and investments, and we have enough cash to continue to invest in the things that are important for us to get ready for the launch. I will note here that it will be important for us to capitalize the company through that launch, but we have plenty of cash to get ourselves prepared to launch the product in this year, as I stated earlier. So let me close you out as I started you out. This is the year for Lexicon in the steak hopes. Sotagliflozin has been advanced for heart failure with the FDA. Should we get the leg we want, it should yield a unique outcome for us, while we have the opportunity to participate in a multibillion-dollar double-digit growth overall heart failure market, we believe we can have peak blockbuster potential with this compound, and we expect to launch it in the second half of this year if it's approved. As I just finished with saying LX9211 will have call out on that data, and I feel very confident if we have a signal here, then this will be very transformative for our company and remarkably value creating for our shareholders. With that, I want to thank you for giving us an opportunity to talk about the progression of Lexicon. I will turn it back over to JPMorgan for Q&A.

Great. Thank you very much, Lonnel. [Operator Instructions] And maybe I'll start with a few questions on sota. So I'm just wondering, can you remind us like what the key differentiation point of sota in your mind if it's true and going into the marketplace comparing to not only other SGLTs, but also ENTRESTO, right, who is on the market and what's the proof heart failure with preserved e fraction, but with some controversial result, I believe. So I would love to hear about your view on the potential of sota in the market for heart failure with preserved ejection fraction.

Let me make a couple of points, and then I'm going to turn it over to Dr. Granowitz to make the clinical argument. The first thing is, I would say, ENTRESTO is a very good drug. As we looked at the sequencing, I don't think they just created a $3 billion global drug because it doesn't work. It works in the population that it works in. When you go back to our SOLOIST study, and that is that when patients show up in the hospital, they're already on a lot of these drugs, ACEs, ARBs, ARNIs, including ENTRESTO, and they need an invention immediately. Today, the only company that has data on a registration basis for recent and worsening heart failure will be sotagliflozin, and that's coming from Lexicon. So that in and of itself will indeed be differentiated. The second thing I would say is that SGLT class, particularly dapagliflozin and Lilly's compound empagliflozin, great results, will be great participants in the heart failure market. And it's important that they do participate because awareness and investments and awareness will only grow the market. Going back to the slide on global data, to get to that $22 billion worldwide market, you need players investing. And it's great to see that those companies are investing. But we have a uniqueness, I think, when we look at the total continuum of ejection fraction, whether it's reduced or it is preserved. It is very clear, sotagliflozin has a remarkable uniqueness that we think that we can play with them and we can win in the segment that I identified earlier, particularly intervening in the hospital setting. So I think that's where the difference is going to be. But let me turn it over to Dr. Granowitz to talk a little bit about clinically and the differentiation there.

Thank you, Lonnel. Thank you for the question. The way I really try to look at it is the concept of 2 or dual that we have -- it starts with the indication, which is the most important element to payers, clinicians and patients. And as Lonnel mentioned in the slides reviewed, we believe we will be the only product that has data in both recent and worsening heart failure, starting the patient prior to discharge from the hospital, and in the chronic setting, certainly in the SGLT class. So we've got 2 very different indications, one of which we believe is unique. The second is the breadth and uniqueness of our clinical data, not only in terms of having significant benefits in heart failure endpoints in both the chronic and recent and worsening heart failure groups, but also in terms of the MACE events or major cardiovascular events, particularly stroke and myocardial infarction. We believe, again, within the SGLT class, the effects that you see in stroke and MI are uniquely differentiating as well as Lonnel showed the breadth across the range of left ventricular ejection fraction remains consistent and significant across the entire range of left ventricular ejection fraction. The third is mechanism of action that with sotagliflozin, you get all of the benefit of SGLT2 inhibition, but also the unique incremental benefits of the SGLT1 mechanism. As a reminder, SGLT1 receptors are expressed and SGLT receptors are not expressed in a number of important tissues in heart failure and in major cardiovascular events, including endothelium, heart, brain and gut. So again, I think in terms of thinking of pairs or dual mechanism, dual indication for use and dual benefits across heart failure endpoints and major cardiovascular events.

Thank you, Craig.

That's great. And I got a question from the portal here. I think the question is basically focusing on the type 2 diabetes side and wondering what's your thoughts on the potential positioning in the market of sota compared to other T2D drugs has been approved basically and also wondering how do you think the efficacy of sota in -- among the T2D patients can compare relative to the current standard of care for T2D, for example?

Let me start and, Jeff, if okay with you, I'm going to have you -- give your perspective. The first thing is we're not seeking a glycemic control label with sotagliflozin. We are seeking a heart failure label. We see sotagliflozin at this point as a cardiovascular drug that's being used for patients with type 2 diabetes. We're not seeking a label for type 2 diabetes. So I want to be very clear about that. However, we were, I was simply telling you, we'll be as competitive as the SGLT2s relative to glycemic control. But for heart failure, and this is very, very important, we're not chasing type 2 patients. What we're chasing is when a patient presents in the hospital, the vast majority, I think, will be patients who have failed on a multitude of other therapies. And at that point in time, you're looking for something that have shown a tremendous benefit in reducing their risk when they're in the hospital. That's going to be sotagliflozin if we get the label for recent and worsening high failure. That is going to be where the true differentiation is. But with that, I'm going to turn it over to Jeff to talk a little bit more about where we see those nuances.

Sure. Thanks, Lonnel. I think the key point is, as Lonnel mentioned, we're not seeking a label in type 2 diabetes not because we couldn't give a label in type 2 diabetes, but because the value for patients with heart failure is so much more significant. It's a tremendous benefit in terms of the patient because the patient is symptomatic and you address the symptoms and help them feel better. It's a benefit to the patient because you keep them back out of the hospital. It's a benefit to the physician because they're being able to provide something that is a benefit to that patient. It's a benefit that's very clear from a hospital setting because hospitals are judged on readmissions. And they -- although hospitalizations are expensive, heart failure patients are not really profitable for hospitals and particularly not when you factor in the costs of the penalties associated with those readmissions. And obviously, payers are very significantly motivated to prevent a rehospitalization, which is very expensive. And so the value in that setting is so much clearer and so much more significant than the value of incremental A1C lowering. And so that is really where we've chosen to focus. We intend to be a cardiovascular drug for use by cardiologists and heart failure specialists. That's our plan and where we think the drug creates the most value and where we think it can create the most value for Lexicon -- patients, Lexicon, our stakeholders.

And Jeff, the only thing I'm going to add again here is that sotagliflozin, should we be successful in the label, will be the only SGLT with a recent and worsening heart failure label. And therefore, when the patient shows up in a hospital, using sotagliflozin will be on label. Anything else you use will not be on label in terms of SGLT. So it is a defining position for this drug. And again, if we're successful, that will be the biggest differentiation with the net setting.

That's very helpful. So you mentioned a little bit on potentially what could be on the label. So just a follow-up from me. And how should we think about the kind of label language? And now we might be still in premature to talk too much about it, but just love to hear any color that you might be able to provide us regarding on, are you guys looking on -- looking at like heart failure with T2D patients? And then would those heart failure with reduce and preserve ejection fraction include in the label specifically? And how are you thinking about along these lines?

Great question. Again, I'm going to ask Dr. Granowitz to take that one.

Thank you, Lonnel. We're really looking at, as Lonnel mentioned, the SCORED and SOLOIST patient populations as 2 distinct patient groups in need both of whom are at risk for heart failure and heart failure endpoints and for which sotagliflozin has demonstrated compelling and statistically significant benefit. So we're looking at the chronic stable heart failure, which is like the SGLT2s that is the 1 of 3 with EMPA and DAPA. And we're looking at the recent and worsening heart failure, which, again, the European Society of Cardiology identified as a unique population for sotagliflozin. We are obviously going to expect to be labeled, what we studied, which is patients with type 2 diabetes, but on the upside across the entire range of left ventricular ejection fraction. So we believe it's going to be a very clear case for which patients to be started. If you are a readmission or an unscheduled visit to the ER for heart failure and you have diabetes, this is the drug to start on before you are discharged from the hospital as part of your armamentarium of medications to prevent you from coming back to the hospital for heart failure. And by the way, if you're a chronic heart failure or recent and worsening, you're also probably going to get an incremental benefit in reducing major cardiovascular events, particularly stroke and myocardial infarction.

Got it. That's very helpful again. I have another question from the audience. So basically, he or she is wondering how you think about the partnering opportunities in the U.S. market. And also, I would love to combine this question, another one for myself and outside the U.S., right, how you're thinking about the potential opportunities. So I guess you might need a partner for ex U.S. market because it's just so large. And how do you think about that?

Let me start with the ex U.S. The ex U.S., we will definitely need a partner outside ex U.S. But I also say that's very thorny and challenging because you're not dealing with the best payer environments today, particularly in places like Europe. But we are in those discussions, certainly to be able to take sotagliflozin outside the United States and have other patients have experience with it. As for the United States, we're fully committed to going alone into this market. I think the more -- just going back to my history of having launched a number of products, the more I dug into the data and where the business was and where the opportunity was, and the more we had conversations with potential partners, the more committed I got we could do it on our own. Because we get into these discussions, particularly in the U.S., to take one of these large partners, you can give up a lot of value in trying to get size. And that's why I go back to that chart. When I looked at where the prescription study, 60% of your prescriptions and particularly look at products like ENTRESTO, the number of years that Novartis have been out there, still, 60% of those prescriptions are coming from cardiologists, and that's about 8,000 of those cardiologists. And so not much has changed. Our intent is not to push out in primary care. It's to make our -- this is a cardiovascular drug for cardiologists. And if we focus there, we can create a remarkable beachhead of opportunity. So we don't need a significant partner. I would also say when you get into those accounts, when you look at the concentration where patients are, you can only rotate on these folks so much and so often, so you don't need an army. Now if you want the incremental benefit of additional sales, then you certainly can hire an army. But if you just want to yield value from a segment of this market, given the size of the opportunity and the growth, then it's best to concentrate your efforts. And therefore, we made the decision of going along in the U.S. Now with that being said, when I look at the ESC guidelines and what I think the treatment guideline is going to be here in the United States, it will make a lot of sense as you move product into market, get a lift on it. There should be conversations with other companies to then make the market more efficient. I mean there is a great opportunity to work with companies that may have an MRA because I think it's going to be an important part of the treatment paradigm for heart failure. There's an opportunity to talk to companies with an ARNI. It, too, is a great opportunity to address patients in the heart failure market. As long as the uniqueness of sotagliflozin as part of that conversation, then there is an opportunity once we get lift to also be one of the companies that create greater efficiency in the heart failure market. But only after we get the lift because in my opinion, that's how you create value out of partnerships.

Got it. That's very helpful again. We have run out of time, but if I could, I'll just squeeze in the last question on Q1. And can you remind us, is there any impact from COVID on the data readout? And how should be thinking about the time line for both data readout and also potentially any next steps.

That's a great question. When we set -- reset the time line for the first half, it was to take into consideration -- and we may have another event and certainly, Omicron is upon us. But with that being said, we're well on schedule at this point, particularly with the DPNP study because it's here in the United States, that we'll be in a position to call out data. Now the PHN study is a global study, and so that has a little bit more challenge given different countries react differently to the outbreak of any variant. But more importantly, the DPNP study, I can tell you, for sure, we are making great progress, and we will be in a position to call it out. And not too long after that, we'll be in a position to call out the PHN study. So I think we've managed as well. And we will be in a position to talk to our stakeholders about where we're going to be with 9211 toward the end of the first half of this year.

Great. Thank you very much. I think our time's up for today's section. And thank you for the Lexicon team who's joining us today, and thank you, everyone, for listening and dialing. Thank you very much.

Thank you.

Thank you.