Good day. Thank you for standing by. Welcome to the preliminary results of the BeAT-HF post-market randomized clinical trial conference call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask the question during the session, you will need to press star one on your telephone. You will hear an automated message advising your hand is raised. To withdraw your question, please press star one again. I would now like to hand the conference over to your first speaker for today, Nadim Yared. You may begin. Thank you. Good morning, thank you everyone for joining us today for this important update. I am excited to share with you some additional context to the press release that we issued earlier this morning, where we shared the preliminary top-line results to the post-market phase of our BeAT-HF trial. As we stated in the press release, we have secured a spot at the Transcatheter Heart Failure Therapy Conference, or THT in short, in Boston on March 21st at 10:45 A.M. Eastern Time, for a member of the Executive Steering Committee of the trial to present the full data. We will hold an Investors Conference Call later that day. For now, I will be limited to speaking only about the preliminary results that we shared in our press release. I will not be able to share with you the magnitude or statistical significance of any trends beyond what is described in our press release. Before we go further, I need to state that the remarks today will contain forward-looking statements, including statements about expected product developments, regulatory matters, and business impacts. The statements are based on plans and expectations as of today, which may change over time. In addition, actual results could differ materially due to a number of risks and uncertainties, including those identified in the press release issued prior to this call and in the company's SEC filings. To help you better understand the preliminary data from the post-market phase of the trial, I think it would be helpful to start by reminding you about the study design. The BeAT-HF trial began enrollment in 2016, with a total of 408 patients being enrolled into the first phase of the trial. An intended use population of 264 patients was identified and was the basis for the six-month data on safety and symptomatic improvement that led to FDA approval in 2019. Let's go to the next slide to review some of the key data points that led to that approval. Starting with improvements in exercise capacity as measured in a standard six-minute walk test. You can see that those patients receiving Barostim plus guideline-directed medical therapy or GDMT in short, that are represented in the dark blue, had a 60-meter improvement in their six-minute walk distance when compared to the control group in the light blue, who remained on GDMT alone. There are two very important data points to help understand the magnitude of that improvement. The first is what has been established as being clinically meaningful. It's 25 meters, as you can see in the dashed lines running through the bar graphs. The results in this measure were more than twice what is considered clinically meaningful. The second is data from several of the landmark CRT, Cardiac Resynchronization Therapies trials from the early 2000. As you can see, the differences in the patients with CRT and GDMT versus those who were treated with GMT alone was more in the order of 30 meters- 40 meters. The results in patients with Barostim were almost twice that. For the sake of time, I will only briefly touch on the other two measures. You can see a reduction in the quality of life measurement as measured by the Minnesota Living with Heart Failure Questionnaire showed an improvement in the Barostim-treated patients of 14 points compared to the control group. Remember now in this assessment, negative scores are better. As you can see, this is more than twice greater than the five-point improvement that has been established as clinically meaningful. The third graph shows that 34% more patients who received Barostim on top of GDMT improved their New York Heart Association or NYHA in short classification as compared to the control group. Before we leave this slide, I'd like to remind you of how incredibly important these impressive data have been to us. Along with the safety profile and other confirmatory endpoints, this is the data that led to FDA approval without the need to go to panels and the rapid increase in adoption of the therapy that we have been reporting over the last two years. Let's move to the post-market phase of the trial. Again, here is the basic study design at the beginning as I shared with you earlier. As you can see, an additional 59 patients were enrolled into the trial that when combined with the original 264 patients in the intended use population, increased the total number of patients to 323. You can see on the bottom of the slide some of the endpoints, but let's examine them more closely on the next slides. Starting on the left side of the slide with the primary endpoint that was a composite endpoint of cardiovascular mortality and heart failure morbidity. Let's define these terms. Cardiovascular mortality was comprised of patients who died or received a left ventricular assist device or heart transplant. These are terminal censoring events. They can occur only once per patient, and no further data is collected if they occur. Heart failure morbidity is a combination of heart failure hospitalizations and ER visits that required an IV diuretic. Heart failure morbidity events can occur multiple times in a single patient during the trial, and the total count is used in the calculation of this component. The composite endpoint was the rate of total cardiovascular mortality and heart failure morbidity events analyzed using a negative binomial method. As you know from our press release, this primary endpoint was not met. There wasn't a statistical difference between the two groups. Are we disappointed in that? Of course. Of course, we are. It would have been great to have demonstrated a statistically significant difference in this endpoint. I am excited about what we observed on the right side of the slide. This portion of the slide describes some clinically meaningful pre-specified analysis. In previous investor meetings, we have described the importance of the totality of the evidence to FDA. A pragmatic review of the totality of the data goes beyond the primary endpoint analysis. Let's take a closer look at these analysis to show you why I am excited by what we have reported. Let's start with the why. Why do a win ratio analysis? If I could draw your attention to the gray box at the top of the screen, it will highlight two major limitations when powering a trial for a Mortality and Morbidity endpoint. The first limitation of traditional methods of analyzing event endpoints is that it only uses information from patients who had an event, and that may represent only a fraction of all of the patients that were enrolled in a trial. The second is the lack of a hierarchical aspect that actually treats all events in a similar fashion. Death and heart failure hospitalization may be equal in what it means to the number of events in a trial, but they are not equal to what they mean to a patient and to their physician. The hierarchical composite analysis using a win ratio method captures the hierarchical experience of all the patients in the trial. Let's take a look at how these are measured. Starting from the far left, you can see that every patient in the Barostim arm is compared to every patient in the control arm. Each pair of patients is then analyzed through the hierarchy of events to see who had the better outcome. For instance, in a pair being analyzed, if both were still alive, but the patients in the control group received an LVAD and the patients in the Barostim group did not, then the Barostim patients would be the winner in that pairing. Approximately 25,000 possible pairs were analyzed, and the results will be described as a ratio of the total wins of the Barostim arm divided by the total wins for the control arm. If the result is greater than one, it means the patients in the Barostim arm were more likely to have a better outcome than the patients in the control arm. As we communicated, this hierarchical win ratio favored Barostim. Now, while this analysis may be new to many of you, the computational power available these days is making it a very popular method of gaining a better understanding of the results of cardiovascular trials. We look forward to sharing these results with you at THT in Boston. Clinical stability. The clinical stability analysis is another standardized way of assessing patient outcomes in clinical trials. It simply assesses each patient, then assigns them to one of three outcomes. They either improved, stayed the same, or worsened. You can see o n the screen the specific criteria for each of those assessments as pre-specified in our trial. Again, we communicated this. I'm sorry. We communicated that this analysis favored patients with Barostim. Terminal endpoint analysis. In the Be AT-HF trial, the terminal endpoint analysis is a composite endpoint using a Cox proportional hazards model that looked at all causes of death, LVAD implantation, and heart transplantation. The description of this is often stated as LVAD and heart transplant-free survival, similar to how we described it in our press release. We stated in the preliminary top-line results that this very important measure favored Barostim. Mortality is considered a hard outcome in clinical trials and is an important measure to patients and their physicians. We look forward to having the full dataset presented at THT. Let me summarize the key takeaways and the next steps before opening the line for questions. Barostim is currently FDA-approved for the improvement of heart failure symptoms based on the pre-market phase data at six months. We have demonstrated a solid adoption rate in the USA based on the six-month symptomatic data. While the post-market phase of the BeAT-HF trial did not meet its primary endpoint assessing the cardiovascular mortality and heart failure morbidity, the safety profile and improvements in heart failure symptoms we showed in the pre-market phase of the trial have now been shown to be durable out to 12 months and were pre-specified and assessed to 24 months. This is incredibly important as I believe many physicians want to see that this benefit is durable. Now we believe that Barostim may provide additional clinically meaningful benefits as assessed using pre-specified analysis such as the win ratio, the clinical stability, and the terminal endpoint analysis. We believe that the new data, when presented, will be compelling to our customers and strengthen the case for Barostim. We look forward to having the full data set presented at THT on March 21st as a featured presentation so that physicians can learn more about the results of this phase of the study and evaluate clinical benefits of Barostim for their patients. The Executive Steering Committee of the trial is planning to submit a manuscript with the results to be published in a peer-reviewed journal. We plan to compile the full clinical report and submit it to FDA to seek an expansion of our labeling. Now, I would like to open the line for questions. Operator? Thank you. As a reminder, to ask the question, you will need to press star one one on your telephone. To withdraw your question, press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Robbie Marcus with JPMorgan. Your line is open. Great. Thanks for taking the questions. Nadim, maybe to start, you know, you said your plan is to submit the trial findings to the FDA for a PMA supplement, but at the same time you're not talking about statistical significance. Is it fair to assume that when you talk about trends favoring Barostim, they must reach statistical significance to get them included in the label? Robbie, fantastic question. Thank you again for joining us today. I know it's been a busy morning for you. Listen, yes, FDA usually require statistical significance. Usually a statistical significance is meant to be a p-value of 0.05. That said, I've seen in some situations where FDA would say publicly, not to throw the baby with the bath water. I've heard them say that expression exactly. In our case, I cannot comment at this stage, unfortunately, on the magnitude of the effect or the statistical significance of any single point. Got it. Okay. you know, as you think about the commercial rollout here, obviously the trial not hitting the endpoint, is gonna be a headline negative to doctors, and we'll have to wait to see the benefit of the individual line items in the trial. What's your expectation for how this might impact, positive or negative, the commercial rollout of Barostim, if at all? Thanks a lot. First, the guidance that we articulated back in January when we announced the results end of January, is still, I'm sorry, is the guidance that we published. There is no new guidance in here to say at this stage. That said, I personally believe this data is net-net positive, here is why. Number one, the long-term symptomatic benefit, long-term safety confirms what we've seen previously, not only to 12 months but also where assessed and pre-specified to 24 months. Second, it's, you know, in heart failure for many, many decades, therapies that improved symptoms end up having a negative effect on mortality, a negative effect on mortality. Meaning patients who took those drugs back in the days to improve their symptoms end up dying faster. Here, with the terminal analysis, terminal endpoint analysis, we're showing that the data favors Barostim over control. I think beyond the negative headline, as you mentioned, when people start looking into the data and when we will have an opportunity to share that data with them, both at the, at the feature presentation at THT and later on in a manuscript, and depending on the labeling that FDA will provide us, I believe that the net-net will be positive to CVRx. Got it. Okay. Thanks a lot. Thank you. Thank you. Please stand by for our next question. Our next question comes from the line of Matt O'Brien with Piper Sandler. Your line is open. Hi, this is Sam on for Matt. Could you speak to the rate of heart failure hospitalizations a bit? You know, we were thinking that more favorable LVAD implantation and heart transplant would also mean better heart failure hospitalizations. Your thoughts on that would be great. Hi, Sam. This is Jared Oasheim, CFO here. Nadim's line got disconnected again, so I'm gonna go ahead and take this one. At this point, we can't speak to any additional data that wasn't already included in the press release. For the heart failure hospitalization information, all of that's gonna have to wait until we get to the THT conference when we can give the more full information on the data. Okay, great. Thank you. I guess, one more from us, about the FDA label. Previously, you had spoken to potentially asking for removing the in the label. Is there any change to that plan currently? What we talked about in the press release is Nadim filing for the expansion of the FDA label. At this point, we can't go any further as to what that could potentially be because there will obviously be some discussion with FDA over the next few months. Once we have more information on that, we'll be able to share it publicly. Great. Thanks so much. Thanks, Sam. Thank you. Please stand by for our next question. Our next question comes from the line of Margaret Kaczor with William Blair. Your line is open. Hey, guys. Hopefully we'll get Jared on at some point, but, if not, Jared or sorry, Nadim. Happy to talk to you, Jared. In terms of kind of the thoughts of the timeline events, of events from here and the discussion between you and the FDA right now, how quickly do you think you can kind of turn around, submit this data and go from there? Then, you know, from a thought process of decision points, catalysts and so on, anything there would be helpful. Thanks. The report, you know, it's already 220 pages. I think we talked about this before we actually got to the data release that even with fake data, all of the tables alone result in 220 pages of data. It's gonna take us some time to pull together all of the final information and analysis related to that report before we can submit to FDA. Just based on history, you know, maybe that takes a month or two. Then with FDA, the expectation is that we would see a response around the six-month marker, so around 180 days after the submission. All in, we're talking seven or eight months before we would get to the end conclusion with FDA. Okay. Right. Oh, go ahead. Just saying that's an estimate. Okay. No, it's helpful. I guess it's probably a little bit early, but is this data enough for you guys to change any of your commercial plans or outlook? If yes, if not, you know, when would you expect to make that decision? Yeah, this is another topic we talked about before the data was released, right? We have this first part where we have top-line information going out. We will have more data that's going to be available at THT. We'll be able to share more information there and see reactions from physicians. As Nadim said, we gave guidance earlier in January. There is no update to that today. We are excited to continue investing in the business, you know, seeing the significant growth we've seen historically. Okay. Thank you. Thank you. Please stand by for our next question. Our next question comes from the line of Bill Plovanic with Canaccord. Your line is open. Great. Thanks. Good morning. Can you hear me okay? We can hear you, Bill. Bill, I can hear you too. Great. The sound is a good one. Good. Yeah, tough when it's coming in and out there, Nadim. Just on Entresto and the new HF drugs, how could they have impacted the differences between the arms for the M& M data? Just any thoughts on that would be helpful. Thanks. That's all I have. That's a fantastic question. You know, the problem that this trial has faced is the duration, seven years. We designed the trial in 2015, and we're showing the data in 2023. Over seven years, two new drugs were approved, Entresto, an ARNI, and SGLT2. If all of the drugs were adopted the same way between the arms, then the impact would be neutralized. If there is a differential introduction of the medication in each arm, these could have impacted results. That's all I can think about. Great. Thank you. Thank you. Please stand by for our next question. Our next question comes from the line of Frank Takkinen with Lake Street. Your line is open. Great. Hey, thanks for taking my questions. Wanted to start with the reimbursement topic a little bit. Could you just touch on any expected positive or negative changes to reimbursement from this data? Hey, guys, sorry again about the issues with Nadim's mic. I'm not sure what's going on there. Just to reiterate on the question from Bill on Entresto and SGLT2, to clearly state, we know that those drugs were released throughout the trial, and if there is an uptake, a higher uptake in one arm over the other, it could have an impact on the results that we see in the trial. We can't give any additional information on that topic as far as what we observed until we get to THT. Frank, for your question on the impact to reimbursement, this is something we've been very clear on over the last year in communicating to all of the investment community, is that this readout of the trial has no impact on the reimbursements that we have today. We have the transitional pass-through, the add-on payments for our outpatient procedure, that stays, right? There is nothing that was dependent upon the readout of this trial for our reimbursement. The additional data that we have that will be released further at THT will allow us to have additional conversations with physicians and with payers. We expect no negative impact on reimbursements from the readout of this trial. Okay, that's helpful. Then maybe one more for me. In the concept of kind of pull forward demand from physicians, just curious if anecdotally you were hearing anything from physicians adopting the Barostim technology under the premise that it wouldn't meet the M&M data endpoint so that they could start kind of offering the technology in front of that change. Any sense to that concept on a pull forward demand scenario under the idea that mortality and morbidity would be positive, or is that not something that was occurring in real time in the market? Thanks for the question, Frank. Yeah, that is not something that we've heard about from our customers to date. At this point, all of the reasons that they're using the device over the last two years and the ramp that we've seen is based purely on the symptomatic data that we had as a readout from six months. Nadim mentioned this earlier, that, you know, we now have 12 and 24 months symptomatic data that looks positive and the additional analyses that favored Barostim. We will see the reaction from physicians after the full data set is presented at THT. Historically, none of it was dependent upon an assumption that we would see a positive readout from Morbidity and Mortality. Okay, great. I'll stop there. Thanks for taking the questions. Thank you. Thank you. Please stand by for our next question. Our next question comes from the line of Alex Nowak with Craig-Hallum. Your line is open. Okay, great. Good morning, everyone. I just wanted to confirm the secondary endpoints, those are stat sig or was it that you just don't know at the current state, just given the analysis is still underway? Hey, Alex. Yeah. Nadim mentioned this earlier, maybe his line was breaking up a little bit. You know, at this point, we're not able to talk about statistical significance as that data has been embargoed for the THT presentation. The only thing that we can say at this point is that they favored Barostim, and that's in line with what we had communicated in the press release. Okay, understood. Then what other secondary endpoints were ran and assessed, and generally, what was their outcomes in addition to the ones we've talked about this morning? Yeah. Any additional analyses are gonna be discussed at THT. Like I mentioned before, the, you know, the jumbled data before we had the actual information in that clinical report was 220 pages. There are a lot of analyses that were run and more data will come out over time. At this point, the only thing we can mention is the information that's in the press release. Okay, that makes sense. Just clarification, what will be the actual FDA label that you submit for? I kind of a follow-up question to that is what comps do you look to out there that you're using to assess to kind of guide this FDA submission process? You know, you're kind of in a special situation here. You showed a symptom improvement, you got approval, you're missing the primary, but you also have very favorable secondary endpoint. Is there anyone out there you could use as a comp here? Yeah. On the first piece, you know, what will FDA allow us to claim for a label? We mentioned that earlier. We're not gonna go into details on what that would look like and negotiate it here publicly. You know, we'll have conversations with FDA as we get to the submission phase and see what the label could look like in the future. As far as comps go, I think, you know, we have seen some other trials that have missed the primary endpoint, you know, the CardioMEMS as an example, where they then went to FDA with secondary and pre-specified analyses and were able to get an FDA approval. These situations do exist in the past. You know, for us, it's about submitting the totality of the evidence to FDA, to then get their response as far as what the label could look like in the future. Okay, understood. Thanks for the update. Thank you. Please stand by for our next question. Our next question comes from the line of Robbie Marcus with JP Morgan. A follow-up. Your line is open. Yeah. Thanks. Just a quick follow-up from me. Jared, I believe you did an analysis adjusting for the impact of COVID on the trial. Anything you could comment on that outcome? Thanks. Hey, Robbie. Thanks for the question on that one. That is another one of the analyses that are gonna have to wait until we get to THT before we can go into it any further. We're excited to share the full set of data with everybody at THT. Okay, great. Thanks a lot. Thank you. Okay, I'm showing no more questions in the queue. I'd like to turn the call back over to management for closing remarks. All right. Thank you, operator. Thanks again, everyone, for joining us today on our update call. We appreciate your ongoing support and look forward to providing more information on the full trial results at THT on March 21st. Have a great day. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.