Great. Good afternoon, everyone. My name is Jessica Vega. I'm a biotech analyst at JP Morgan. We are delighted to be continuing the conference today with Esperion. We're not gonna switch rooms for Q&A. Instead, if you have a question after the presentation, you can raise your hand. Someone will bring you a microphone or, you can submit your questions electronically as well. With that out of the way, let me turn it over to Esperion CEO Sheldon Koenig for the presentation.
Good afternoon, everybody. Thank you. On behalf of Esperion, the company, all the employees, we're very happy to be here. Thank you to JPMorgan as well for allowing us to be here and share with you what's been really an exciting couple of months and a really exciting couple of days. We're happy here to share that excitement with you. I have a countdown timer on my phone, although I don't have my phone on me 'cause I can't bring it up here. We're about two months and a couple of hours away from full data release of the CLEAR Outcomes study, which again, will occur on March the 4th, 9:30 central time at ACC. I just also wanna mention that this is a late breaker clinical trial being presented by Dr. Steve Nissen out of the Cleveland Clinic.
It's also what's opening up the conference, so it's the big show, the big event at the American College of Cardiology. For some of us who've been in cardiology for many years, it's a big event. We feel really good about it, and look forward to seeing you in New Orleans, if not virtually. Our forward-looking statement and disclosures. Let me first start by talking about our three-step plan to build shareholder value. We're continually, appropriately building the awareness of NEXLIZET and NEXLETOL. Of course, as we've announced, we met our top line related to the CLEAR Outcomes study. We purposely did not include a hazard ratio or a p- value. We've been consistent in stating that.
The reason for that is we do not want to break our embargo with the American College of Cardiology, nor do we wanna risk breaking the opportunity to have a simultaneous publication in a journal such as New England Journal of Medicine. By the way, I'll say this now. ACC is just the start of information. We have a series of other presentations that we're planning at major scientific meetings, but of course, at ACC, it'll be the kickoff of the CLEAR Outcomes results amongst doctors, patients, and yourselves, investors. Obviously, we're thinking about how do we actually pursue label expansions, and we do intend to file both in the United States and Europe. Esperion is responsible for both of those filings. We will file simultaneous the U.S. and E.U. labels.
They take about 10 months to review, and that will occur sometime late in the 3rd quarter of 2024. This is a large market. This is a multi-billion-dollar market, and we believe we have a product with a product profile and now with cardiovascular outcomes to actually achieve bempedoic acid, both NEXLETOL and NEXLIZET in blockbuster status. We're really excited about that opportunity. With our study, we have really leveled the playing field. We've already conducted market research, both from a qualitative perspective and quantitative perspective. We've always been anticipating what we thought our results would be. We've tested it with payers, we've tested it with physicians, and I can tell you, we feel very confident about the ability to actually grow these products. Prescribing will change. Barriers related to market access will also be less, which will allow more prescribing.
I failed to mention the aspect of our milestones. I want to spend just a few seconds on that. You may have seen that on Sunday, we had a press release, our first bullet point on the press release was not only do we meet our primary endpoint, we also had positive results among key secondary endpoints. We did acknowledge that. We had not acknowledged that in the top line, that's because we just wanted to make sure that we essentially are being transparent. We have all of our I's dotted and our T's crossed as it relates to our data, we wanted to go out there with the right data. We are confident, let me state that again, confident that we will receive our milestone payments from our partners, both Daiichi Sankyo and Otsuka.
I think there's been a lot of question about that since we had issued our top line. Again, I'll use the word confidence one more time or maybe the fourth time. I have the confidence that we'll be receiving those payments upon inclusion of the outcomes data in the EMA label. We were just chatting in the audience before I came up here. After statins, there's been very few approved lipid-lowering therapies with positive CVOT. As a matter of fact, many of large pharma companies got out of cardiovascular medicine because cardiovascular trials are such a heavy lift. Heavy lift not only as it relates to performing and doing the study, but the cost of a study. Our study, for instance, is anywhere between $400 million-$600 million when you look at all the personnel, et cetera.
Many of these studies that you see on this chart, I've lived through. Some of those were $500 million- $1 billion. The point to take away from this slide is the fact that most fail. Most of them fail. Just taking a look at IMPROVE-IT, which is ezetimibe. Ezetimibe was a statistically significant positive study. However, Merck never filed for an indication related to that product. All these other products that you see on the bottom designated as red, these are products that weren't out on the market yet, had outcome studies, and all of them failed. Again, super excited about we had one that's positive, and not many companies can actually say they have a positive 14,000 patient cardiovascular outcomes trial. NEXLETOL and NEXLIZET truly optimize to address an unmet medical need.
We're not going to replace statins, and statins still remain the first-line therapy of major adverse cardiovascular events. However, we do know that lower dose statins and withdrawal from statin therapy is associated with increased risk of adverse cardiovascular events. This is my first public service announcement where I will tell you, if you have not gotten a lipid panel recently, you should. We were talking about earlier that every 34 seconds, somebody in the United States has an MI and be reminded that cardiovascular disease is still the number one cause of death in the United States and honestly, in the entire world. We know that up to 30% of patients are unable to tolerate guideline-recommended doses of statins, and we also know that like statins, NEXLETOL, bempedoic acid, actually up-regulates LDL and increases clearance of LDL cholesterol from circulation.
I think an easier way for to say it as a non-scientist and a physician is we work upstream from HMG-CoA reductase inhibition. That's why we somewhat call this a designer drug. It's a drug that was designed to address the muscle pains associated with taking statins, the side effects of taking with statins, and we know that there's many patients, as I mentioned earlier, who can only take a certain dose or who can't take a statin at all, and we plan to really own that segment. Keep in mind, NEXLETOL and NEXLIZET can also be used with statins, we can be used with PCSK9s, and we believe, based upon our cardiovascular outcomes trial, that with our filing, as you know, this study addressed a broad secondary population and a primary prevention population, so secondary prevention and primary prevention.
We believe when we do our filing, et cetera, we'll have the ability to potentially not only talk about secondary prevention but also primary prevention, and that's important for many reasons, as you know. The CLEAR program has assessed the impact of NEXLETOL and NEXLIZET in combinations with statins alone on key endpoints, including LDL lowering and CV outcomes. Again, it gets to the fact that this is a drug that's been designed to help those statin-intolerant patients and patients already on therapy, on statins, et cetera, to get them to LDL goal. Now, with that said, there's been over 60,000 patients in over 30 countries that we studied bempedoic acid. I won't go through all of these for the sake of time. Some of these are actually studies that we're beginning.
We actually have a study that we'll be starting soon with Kaiser in acute coronary syndrome patients. We've already actually presented the Baylor Scott & White. There's real opportunities there. We're looking at ways to work with other segments as well. You know, we're really proud about the background of work that has been achieved with these products. Which leads us to what's the cherry on top, and that's the landmark CLEAR Outcomes study. Now, we've used a lot of adjectives to describe our study. We've talked about clinically meaningful, and we've received a lot of questions on what does clinically meaningful means. I think that's where there's a divergence of the investment community and the medical community, to be frank.
Clinically meaningful means this will make a difference in an option that the physician will have to treat a patient, and I've already talked about some of the various patient types. Landmark. Landmark because it was the first study to ever study patients defined as statin intolerance. Also just from the perspective, as I mentioned, because it was positive. This is something I'll show you a bit later of how key opinion leaders also think about why this could be a landmark study. It's first of a kind, unprecedented CVOT. We focus on significant, unserved population unable to maximize or tolerate statins. Our primary endpoint was a MACE-4 endpoint, the composite of time to first cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or coronary revascularization.
By the way, one of the differences with this and the PCSK9 is they actually looked at unstable angina in their MACE-4 endpoint. Our study was conducted in over 14,000 patients in 32 countries. There's a lot of discussion around diversity in studies. We actually believe that we have one of the first studies that's really looking at diversity. Dr. JoAnne Foody, our Chief Medical Officer, is here with me, as well as our Chief Financial Officer, Ben Halladay. JoAnne, if you don't follow her on Twitter, please do, because she talks about the incidence of cardiovascular disease in women. Cardiovascular disease in women is the number one killer in women today in the United States, closely followed by breast cancer. Our study had approximately 50% women in the study. Now, I wanted to save this part for last. I briefly mentioned it.
As you recall, when we issued our top line, we didn't talk about the secondary endpoints, but I wanna talk to you about statistical hierarchy. Our primary endpoint was MACE-4. Once you receive the fact that you have a positive endpoint there, you can then go through the statistical hierarchy of secondary endpoints. We received a lot of questions of what they are. It's MACE-3. It's fatal and non-fatal MI, coronary revascularization, fatal and non-fatal stroke, death from cardiovascular causes, and all-cause mortality. As I mentioned, we hit key secondary endpoints, and we'll go through the results of all of that, actually, Dr. Nissen will at the time of ACC. Again, the importance of having a simultaneous publication is there's only so much you can cover in that 15 - 20 minutes for Dr. Nissen.
You'll be able to have a 15-20-page manuscript with all the data, Kaplan-Meier curves, et cetera. Again, our hope is it'll be in a top-tier journal such as New England Journal of Medicine. Just a little bit of a flavor from what key opinion leaders are saying. I really love what Dr. Kausik Ray says. Many of you have probably heard of him. He's been in the cardiovascular world for a long time, as had Dr. Michael Gibson. He refers to this as the fifth mechanism of LDL lowering that has translated into reductions in cardiovascular events. Another key takeaway here is the fact that bempedoic acid, both NEXLETOL and NEXLIZET, post statins, will be the only small molecule oral non-statin that will have outcomes data in the language. Again, something that's very important.
fifth mechanism of LDL lowering that has translated into reductions in cardiovascular events. The question, though, is do we need another asset? We absolutely do. You heard why from the design of this drug, by the design of our study, and by the fact that we know currently there's still 18 million patients in the United States who are not at LDL goal, which leads to why we're seeing so many MIs still today. Mike Gibson, his thought about this also is now that we have a tool like this is yet just another tool that we can treat patients more urgently.
I think there's this belief out there as a non-physician is that when you're diagnosed with a cholesterol high LDL issue, it's like, "Well, I can take a drug and everything will be fine from there on." It's really about early treatment, early prevention, and that's what he is trying to stress. We're going to do our job in promoting our data once we have our label. We're actually going to start preconditioning the market even now, which I will get into. Key opinion leaders are really excited about the fact that the study is positive. A lot of stakeholders are excited about this. We've heard from peers of the companies we used to work in. They're excited about studies like this. They wanna know more about it. It's really brought a lot of attention back to the cardiovascular community.
What are we doing from a commercial perspective? Well, we're doing a lot. I've already talked about our market research. We're actually doing work right now to evaluate what we need to do to increase our field sales force. We're working with ZS to optimize our field sales force. I won't go into specific numbers, but what I can tell you is we hope to have a pretty good number of people ready by the fourth quarter of 2023 to be trained, et cetera, put in territory, and be ready for when the label comes out late sometime in the first quarter. We're preparing for our CLEAR launch campaign and promotional messaging. We've been working on that. We've been working on what our aids would look like. We're refining our positioning.
I think something that's important, we actually released what our top-line net results were for the fourth quarter. Keep in mind, even back in October of 2021, we stated that we would be able to demonstrate continuous growth through 2022, albeit very small. We purposely downsized our field. We have 60 representatives out in the field today. This is a broad primary care market. We're selling more at 60 people than we are with 300 people. You may ask why, and the reason is because we have the right positioning, we have the right strategy, we have the right leaders, and we have the right people in the field, and we made a concerted effort to do that. This is our financial strength to deliver growth. We finished fourth quarter with $166 million in cash and cash equivalents.
We talked about our milestones. The milestones related to DSE are up to $300 million, with Otsuka $150 million. When you look at everything combined with potential future milestones from partners and royalties, that is greater than $1.2 billion. We issued our range of $14.4 million-$15.1 million, which represents a 38%-40% year-over-year growth. Our timeline and next steps. Well, we're already meeting with payers. We've actually had two large accounts have already removed in the ezetimibe step edit in anticipation of CLEAR Outcomes. Keep in mind, our headwinds, our biggest headwinds have been our prior authorizations, because physicians have to write to label. We see a significant transition in our label from patients not needing to be on the maximum tolerated dose of a statin.
Also we believe that we will be able to go to physicians providing attestation vs having to provide documentation to get patients on bempedoic acid. We've actually tested this with payers. We've actually had an Advisory Committee with payers, and we've shown them what our target label is post-outcomes, and they all believe with this. I mentioned segments earlier. The VA and Department of Defense are very big segments. The VA specifically said to us, "We don't want to meet with you until you actually have outcomes data." When we put the top line out there, we have a meeting with them on March the 6th. Keep in mind, we're presenting the data March the 4th, and we'll be meeting with them on March the 6th. If you haven't seen our partnership with RFK Racing, please check it out.
We have the NEXLIZET and NEXLETOL car. These are actual race cars with NASCAR. This was something that we felt we could do and really get the awareness out there. NASCAR has over 18 million fans. It somewhat has an audience that's could benefit from a NEXLETOL and other lipid-modifying agents. I think the beauty of it is we announced this today, they announced it, and I can't tell you how much awareness we have received. I mean, overnight, within two hours. We're excited about it. We'll actually have a show car at ACC if you're at ACC, so you'll see it. I've talked about when the late-breaking clinical trial is. We are doing these enhanced commercial activities, and I've talked about the fact that we'll be doing a label update.
You can see with the cartoon on the bottom of when the planned timing for this is. three key takeaways for today that if you're to have to remember three things from this chat, and we're always happy to chat with any of you, so please let us know. We have a unique and successful outcome study in a large therapeutic category that demonstrates the benefit of bempedoic acid, the active ingredient in NEXLETOL and NEXLIZET. We're excited about the results that we have, and we can't wait to share the results. We are poised for a major inflection in sales and prescriptions, and as I mentioned, we're targeting blockbuster status.
Based upon the robustness of the CLEAR Outcomes data, the company believes, and the company is confident that we will receive our milestone payments from our collaborative partners upon inclusion of the risk reduction language in the U.S. and European labels. With that, thank you so much.
Great. Thanks for that presentation. As a reminder, if you have a question in the room, just raise your hand or you can submit them electronically. Maybe I'll start. You mentioned the robust effect on key secondaries. Does that mean all those secondaries that you listed hit or the first few, some of them?
Yeah. Yeah. We're actually, you know, we went as far as to say that just to give the confidence within the secondary endpoints because we hadn't mentioned it in the top line. I'm gonna let Dr. Steve Nissen review that and disclose that at ACC so that, you know, we don't debate endpoints. You know, we're confident in the data that we've seen that it's, you know, I think people will be. I'm always picking my words closely, Jess, because, you know, if I use the word meaningful, what does that mean? If I think something's exciting, what do you mean by exciting? I think it really rounds out the study to make it what it needs to be to be a landmark study. Dr.
Nissen, I think, is more appropriately, the person to speak to that.
Okay. We've got a number of questions coming in on the portal, so I'll just start reading some of these off. You mentioned a potential divergence between the investment community and the clinical community on the definition of clinically meaningful. Is that to say that the bar the investment community uses is too high? And if so, what is the bar the clinical community uses?
Yeah. We've never associated a bar relate to residual risk reduction as it being clinically meaningful. We've always just felt it as, and we've used these words, too, and people have asked, "Well, does that mean practice-changing?" It's more the ability of a physician to use something different to get patients to goal, et cetera, is the story that I told. I actually think the clinically meaningful aspect was brought more to attention because it was, do they have enough? Do they have the data to achieve their milestone payments? It wasn't necessarily related to what does it mean from a practice perspective. I think that's what we're trying to get across, is that clinically meaningful, what we meant is that physicians are gonna be very appreciative of the data, patients will benefit.
The reason why we came out with the press release that we did, talking about our confidence in milestone payments, was just to address that and really to kind of, if you would, make them a bit more mutually exclusive.
Great. There have been a lot of questions on the milestones, and maybe just to round that out a little bit, is there any scenario in which the outcomes data gets on the European label and you do not get a payment from Daiichi?
Yeah. As you know, we live in a very litigious society, and, you know, before we issue any type of press release, et cetera, we need to run it through several screens. On our own, when we look at the data, we could say, "Hey, you know, we're gonna get these milestones," but that's not good enough, and it shouldn't be. We have to go through our regulatory department, and then we have to, you know, actually use lawyers, et cetera. I don't see any situation of where, you know, we wouldn't receive it based upon the feedback we've received.
Okay. To be clear, the milestone from Daiichi is associated with label inclusion, not necessarily a specific number?
Yeah. There are numbers associated. We haven't divulged what all those numbers are, but it's label inclusion as it relates to reduction in cardiovascular endpoints. That's essentially how it's, we would define it and would be in the label.
Okay.
There would be numbers associated to that, so residual, you know, hazard ratios, et cetera.
Go back 'cause there's more questions coming in here. I think clarification from one of the comments made during the presentation. Did you say that doctors thought IMPROVE-IT was clinically meaningful? What was the comment on IMPROVE-IT?
The comment with IMPROVE-IT was that the study had a statistically significant p-value. It had a residual risk reduction of 6.7%. The comment I made was that that product was on the market but was never filed for an indication. There was actually an Advisory Committee. I can stand here and confidently say that we are, you know, far and beyond what ezetimibe showed in the IMPROVE-IT study, and it's a brand I ran for four years. I actually ran-
Can you repeat the question?
Oh, yeah, I did. I actually ran Pradaxa for three years. I'll actually use a language that I heard from somebody right in a financial note, not related to JP Morgan. PCSK9s are somewhat unattractive and undesirable. What was meant by that in the note that this person wrote, is that they're hard to get. Primary care physicians, it's very difficult for them to get PCSK9. They actually usually have to go through a cardiovascular type of referral. I think the biggest benefit with us, though, is we're a oral product. Patients and physicians would prefer to have an oral pill vs an injectable. That's a huge differentiation, and we've actually have done market research to demonstrate that.
We're also less expensive, and that means a lot in prescribing today, fortunately or unfortunately.
Some more, questions coming through here. Have you shared the results of the CLEAR Outcomes trial with your partners yet?
With our partners, they've been invited to review the data, and we're just waiting for them to get us the people that are going to review the data.
Okay. Do you expect to get the maximum milestone payment, with inclusion in the European label?
Yeah. We plan on essentially officially disclosing that at the American College of Cardiology, upon the actual presentation. You know, I'll just go as far as to say we feel good about the totality of the milestone payments.
Did the safety profile that you have in the label hold up during the CVOT trial?
Yeah. We haven't specifically mentioned it, et cetera, but we don't see any type of safety signal, et cetera.
Do you think that the CRP lowering effect of the drug had some additional benefit on the cardiovascular outcomes in the trial beyond what might be predicted based on LDL alone?
I think it's gonna be very difficult to tease out what CRP actually does. I think folks are still struggling with that as it relates to the CANTOS trial. You know, we actually work with Paul Ridker, and I think Paul Ridker is one of the foremost leaders in studying CRP and inflammation. We're doing some studies with him. He'll probably make some commentary about CRP reduction. I will say, and that's another differentiation to the question asked earlier, is that unlike ezetimibe, unlike PCSK9, we actually do lower hsCRP, and we also lower glucose, which is something that none of them do. It's another differentiation, and it gets back to this designer aspect of this drug, and you'll hear more about that at ACC as well. I think that's really difficult to tease out.
There's definitely some type of advantage, but for me to stay here and to guess what that is, especially as a non-scientist and a physician, I'll let the experts do that.
Can you talk a little bit more about how you think payer interactions are gonna play out now that you've got the CLEAR Outcomes data?
Yeah. One of the largest headwinds, as I mentioned earlier, is the fact that we have been step edited to either ezetimibe or patients going through two statins. The reason for that is payers will say to us, and I met with a payer last year. This is the best example. I won't say who the payer was, but essentially what he said is, "We have to do this because ezetimibe has outcomes and you don't." Or, "Repatha has outcomes and you don't." It's mostly around ezetimibe. The thing about that, what I said to him at that day was, "Well, ezetimibe does have outcomes. It's not in their label, but I hear what you're saying." The fact is now is we've leveled the playing field.
We have outcomes. We know in working with our payers, that's what they've been waiting for. Now we have something that's easier to take. We have cardiovascular outcomes, the data that we're really excited about, we're really proud about. It's gonna be a joy to present this to payers and physicians, of course, who will benefit downstream because we know they've told us that if we can show them certain things such as, really the fact that we have outcomes that... and our label will change, then the burden of proof from a prior authorization perspective, as I mentioned earlier, will be far less. We did a round table back in Dallas with all of our current payers, these are acting pharmacy directors, et cetera, with as many as we could get.
We just followed up actually a few weeks ago, doing both the qualitative and quantitative study with payers and physicians, testing several results to keep it blinded. Us knowing the results and looking at specific areas, we know that will be the case once we actually have the new label. We can actually meet with payers now, and we're scheduling meetings with payers right after ACC, the week of March 6th. If we have a simultaneous publication from, say, the New England Journal of Medicine, we actually share that with payers. Representatives cannot talk about the study until we have a label. I just wanna make that clear. There are certain folks, medical liaisons, et cetera, can appropriately share data.
Let me think about those key secondaries. I think the first one was MACE-3. I know historically a number of events in these trials were driven by revascularization. In this study, did the proportion of events related to revascularization sort of track with other recent outcome studies?
I can't really speak to that. I think we'll go over that. What I will say about MACE-3 is MACE-3 are hard endpoints. There are a select group of key opinion leaders and physicians out there that will even say that MACE-3 may be more important, because they're hard endpoints, and, you know, I will just say, I think, you know, we're confident based upon our power, et cetera, that, you know, we'll have a favorable result in MACE-3.
Okay. just to clarify the kind of commercial plans from here, I know you had a slide sort of walking through the steps to kind of scale up.
Yeah.
the commercial organization. It sounds like you want all those reps in place ahead of time, so this isn't like contingent offers to sort of suggest-.
Yeah.
-what level of confidence and-
Yeah. Yeah. We have a plan in order to start identifying these folks, we're actually pulling a page out of the old playbook that I did at Merck. We had Pfizer. We're looking for folks. I'll put this out there now in case people are listening. We're looking for folks that are ex-military, college athletics, et cetera. I can tell you, we just hired someone who came out of the Air Force and never sold a pharmaceutical ever and is leading the region after three weeks. So it's a specific type of prototype of a person that we're looking for. We've actually hired somebody who comes from higher education, et cetera, that does training, that can also help us identify folks quickly. You know, we're confident that we're going to get the label that we're going to get.
You know, you don't walk in blindly with the FDA to say, "Here's our data package," et cetera. There's been discussions with the FDA as it relates to the data we would be submitting, and that's through the EMEA as well. We're confident that we can staff up and not take a risk, as it relates to hiring folks, so. We just wanna wait because to put them out any earlier with no new label, just, there really wouldn't be a lot for them to speak about.
Maybe I can try to ask it this way, I guess I sort of think that the stronger the hazard ratio, the stronger the benefit, the greater the peak potential of the product and the greater inflection you can see. Do you agree with that the trajectory will vary based on the strength of the CLEAR Outcomes data?
What I would say is we've actually tested different thresholds as it relates to CVOTs, not only the primary endpoint, but the secondary endpoints as well, because as a representative, you'll be presenting all of those. I do wanna make something clear. I think that's more of a discussion for key opinion leader and academics. I'm gonna answer your question. Prescribing physicians wanna know if you have outcomes. If you get too complicated with them on different numbers, they turn off, and they don't even wanna hear it. What I will tell you is based upon the results that we have and based upon the testing that we've done, we know that we can show a significant inflection point in prescribing.
I just don't wanna get too much into numbers because I don't want to, myself, fall into a trap of disclosing data that's gonna be released at ACC.
Okay.
I've had good practice over the past two days at the conference, so.
Another question here on the portal. Would you expect an Advisory Committee for this review?
No. No. I think again, that goes back to the fact with all the discussions we've already had with the FDA, et cetera, they know what to anticipate. It was a little bit different. They're probably referring to ezetimibe had an Advisory Committee. We would have to spend another session. I could go through why that happened.
Okay. Can you talk about your cash runway?
Yeah. We have enough cash to get us through 2023. We have $166 million in cash at the close of the fourth quarter. Keep in mind, we do have about $309 million outstanding in warrants. They expire December 14th, 2023. We don't really kind of count those warrants. We have them as an asterisk, we're not counting on the warrants. I mentioned the milestones. The milestones would come sometime probably late in 2024. If you do the math, I said we have enough cash to get through the end of 2023. More than likely, we would have to do something upon the presentation of our data to bridge us to our milestone payments, and we believe at that point then we'll be cash positive, if you will.
Great. I can tell you're reluctant to talk about the details of the CLEAR Outcomes down here, but.
Well, it's not that I'm reluctant. I just won't do it. Yeah, 'Cause if I do it, then we won't be able to see each other in New Orleans, so.
What about with potential partners or potential companies with strategic interests? Can you put them under some kind of nondisclosure and start sharing the data with them in advance?
Yeah. We have, you know, met with other companies, if you will, our peers, et cetera, in the conference. We won't do that because we're essentially two months away. I've been on the other side. This is nothing to my friends or colleagues or peers, but this is too important for us to afford a leak. It's just as simple as that. That doesn't mean someone just going out and saying, "Hey, did you hear what I heard?" It could be as simple as just slipping up. You know, I myself almost sent an email to somebody the other day. I looked at, again at the address and, you know, it's like it would've been the wrong person. We just wanna make sure that we take all the right steps to protect this data.
It's too important. We finally feel we're controlling the story now vs others controlling the story, and we're gonna continue to control the story. This gets me back to the medical community. Why is it so important to have a late breaker, a publication? It's important because then it's the medical community saying what's important. It's peer-reviewed, and that also leads to the importance of something we haven't talked about today, and that's guidelines. The quicker we can get that data out there, the quicker guideline committees can start thinking about it, issue a consensus statement even, before the guidelines.
Okay. Well, we're about out of time, so we'll leave it there. Thank you.
Great. Thank you. Thank you, everybody. Really appreciate it. Hopefully see you at ACC.