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spk01: Good day and welcome to the CVRX Q4 2022 earnings call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker, Mr. Mike Vallee. Please go ahead.
spk00: Good afternoon.
spk05: Thank you for joining us today for CVRX's fourth quarter and full year 2022 earnings conference call. Joining me on today's call are the company's president and chief executive officer, Nadim Yared, and its chief financial officer, Jared O'Shaiman. The remarks today will contain forward-looking statements, including statements about financial guidance. 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 earnings release issued prior to this call and in the company's SEC filings, including the upcoming Form 10-K that will be filed with the SEC. I would now like to turn the call over to CVRX's President and Chief Executive Officer, Nadeem Yared.
spk03: Thank you, Mike, and thanks to everyone for joining us today. I'll begin today's call by providing an overview of our fourth quarter and full year performance, followed by an operational update, a review of our financial results by our CFO, Jared O'Shine, and then I will conclude with our thoughts on 2023 before turning to questions and answers. We are very proud of everything that our team accomplished in 2022. It has been a great year for CVRx. We made progress towards all our strategic initiatives, resulting in the increased adoption and utilization of Peristem, despite several macro disruptions throughout the year. This is demonstrated by the fact that our worldwide revenue increased by 72% over 2021, primarily driven by our U.S. heart failure business's 108% annual growth. And the year was capped by a strong fourth quarter. Our worldwide revenue for the fourth quarter was $7.2 million, an increase of 96% over the fourth quarter of 2021. Performance in the quarter was driven by the continued expansion of our U.S. sales force and contributions from our marketing initiatives, which led to an increase in U.S. active implanting centers. In the U.S., our heart failure business generated $6.0 million, an increase of more than 121% over the fourth quarter of 2021. The increase was primarily driven by continued growth and expansion into new sales territories, new accounts, and increased physician and patient awareness. When we went public in the summer of 2021, we were in the very early stages of our commercial launch in the U.S. At the time, we expected to consistently grow this business in line with the investment in our commercial organizations. We are very pleased with how this has played out, with the fourth quarter being our tenth consecutive quarter of increasing U.S. heart failure revenue, with average quarterly sequential growth in excess of 20% since the IPO. Now for an update on operational developments during the fourth quarter to support greater adoption and use of Parastim. Our focus areas were, one, the continued expansion of commercial infrastructure, two, innovation of our product portfolio, and three, the expansion of the clinical body of evidence. Starting with the continued expansion of our commercial infrastructure. During the quarter, we added three new territories, bringing the total to 26. We are excited with the quality of sales talent we have been able to attract and look forward to continue to build upon that quality in 2023. During the year, we generated momentum with several of our marketing programs, including our direct-to-consumer or DTC pilot program, our new branding campaign, and patient education programs. The DTC pilot program has been successful to date and has had a positive impact on our U.S. business. To date, we have made minimal investments in localized DTC campaigns, and we have seen more than 100 patients undergo a barostim implant and have a robust pipeline of potential patients with interest in learning whether they are candidates for the therapy. We plan to continue to optimize these campaigns to make them more cost-effective as we evaluate whether to roll them out more broadly. Our second area of focus is innovation of our product portfolio. During the second half of 2022, we launched BetterSkin Neo2 IPG, the second-generation device which reduces the size of the IPG by 10% and extends battery life by 20%, reducing the frequency of device replacements for patients and their providers. It is remarkable how the NEO2 extends longevity while employing a smaller footprint and allows for a streamlining of the implantation procedure. Our third focus area is the expansion of our clinical body of evidence. The BHF clinical trial was designed to demonstrate that barostim provides a mortality and morbidity benefit in addition to a reduction of symptoms of heart failure in patients with reduced ejection fraction. As previously announced, we accrued the required 320th event in the trial and are working to collect and monitor all the data. As a reminder, the primary endpoint is a mortality and morbidity composite endpoint. And we have pre-specified a few potentially meaningful secondary and ancillary endpoints and analysis. These include a hierarchical ratio analysis, few COVID sensitivity analysis, and ways to account for the severity of hospitalization. While we in the steering committee are still blinded to the results, but also based on how the data collection is progressing, we now believe that we will be in a position to unblind and share the data before the end of the first quarter of 2023. Our goal for this post-market trial is to broaden Baristim's labeling. We plan to submit the totality of the evidence and our corresponding analysis to FDA when we unblind the data. Please note that FDA is the ultimate decision maker on whether to allow additional claims and new labeling for better stem based on its own evaluation of all the available data. FDA will also seek advice from a panel of independent experts. At this point, it is difficult to plan for a specific scenario. The results may produce a conclusion that is more complex and nuanced than a straightforward binary answer. In addition, we continue to make progress with Batwire, our ultrasound-guided implant toolkit. In 2022, we added more sites and more patients into the clinical trial. As a reminder, we expect to complete the trial in 2024. We announced in late September that we added a veteran medical device executive, Kevin Hikes, to our board of directors. Kevin brings his business acumen and his decades-long experience in the field of cardiovascular implantable devices. Additionally, with the promotion of four leaders to the executive team, we now have eight out of ten of our executives promoted internally, showcasing the strength and depth of our talent bench at CVRx. In summary, we had a fantastic 2022 as we considerably expanded the adoption and application of Parastim as seen by 10 consecutive quarters of strong growth in our U.S. heart failure business. The year was topped off with a successful fourth quarter, during which we continued to push the growth of active implanting facilities in the United States, highlighting once more the benefits that Berestem can provide to both healthcare professionals and patients with cardiovascular disease. I'll now turn the call over to Jared to review our financials. Jared?
spk04: Thanks, Nadeem. Total revenue generated in the fourth quarter was $7.2 million, which is an increase of $3.5 million, or 96%, when compared to the same period last year. Revenue generated in the U.S. was $6 million for the fourth quarter, which is an increase of 109% over the same period last year. Heart failure revenue in the U.S. totaled $6 million in the fourth quarter on a total of 193 revenue units, up 121% as compared to $2.7 million in the same period last year on 95 revenue units. The increase was primarily driven by continued growth in the U.S. heart failure business as a result of the expansion into new sales territories, new accounts, and increased physician and patient awareness of barostim. At the end of the fourth quarter, we had a total of 106 active implanting centers as compared to 46 at the end of Q4 2021 and 91 at the end of Q3 2022. At the end of the fourth quarter, we had a total of 26 territories in the US compared to 14 at the end of Q4 2021 and 23 at the end of Q3 2022. Revenue generated in Europe was $1.2 million in the fourth quarter which is an increase of 49% when compared to the same period last year. Total revenue units in Europe increased from 39 in Q4 2021 to 68 in Q4 2022. The revenue increase was primarily due to the lessening impact of the COVID-19 pandemic in Europe. The number of sales territories in Europe remained consistent at six during Q4 2022. Gross profit was $5.7 million for the fourth quarter, an increase of $3 million when compared to the same period last year. Gross margin increased to 79% for the fourth quarter compared to 73% for the same period last year. Gross margin for the three months ended December 31, 2022 was higher due to a decrease in the cost per unit and an increase in average selling price, partially offset by a larger percentage of our revenue units coming from full systems versus battery replacements. Research and development expenses were $3 million for the fourth quarter, which is an increase of 70% when compared to the same period last year. This change was primarily driven by increases in compensation expenses due to increased headcount. SG&A expenses were $14.1 million for the fourth quarter, which is an increase of 46% when compared to the same period last year. This was primarily driven by an increase in marketing and advertising costs associated with the commercialization of BarroStim. as well as higher compensation costs from increased headcount. Net loss was $10.5 million or 51 cents per share for the fourth quarter as compared to a net loss of $10.6 million or 52 cents per share for the same period last year. Net loss per share was based on approximately 20.6 million weighted average shares outstanding for the fourth quarter and approximately 20.4 million weighted average shares outstanding for the same period last year. At the end of the fourth quarter, cash and cash equivalents were $106.2 million. Net cash used in operating and investing activities was $10.9 million for the fourth quarter, compared to $7.6 million for the same period last year. We continue to believe we have enough cash on hand to reach cash flow breakeven without needing to raise additional capital. Now turning to guidance. As announced in early January, for the full year of 2023, we expect total revenue between $35 and $38 million, gross margin between 78% and 79%, and operating expenses between $76 and $80 million. For the first quarter of 2023, we expect to report total revenue between $7.1 and $7.5 million. I would now like to turn the call back over to Nadeem. Thanks, Jadid.
spk03: Before opening the line for questions, I would like to discuss our key areas of focus for 2023 as we seek to drive the increased adoption and utilization of Parastim. First, the continued expansion of our commercial infrastructure, especially our direct sales force in the United States, remains a top priority. We expect to continue hiring top talent throughout the year and are targeting a total of approximately 38 U.S. territories by the end of 2023 or, on average, adding three new territories per quarter. In addition, we will continue to invest in marketing efforts to help drive increased awareness of Parastim. Outside of the U.S., we have added additional talent to our direct sales organization in Germany, and we continue to expect to add incremental headcount in 2023 to support our commercial strategy in that region. Our second focus area is the expansion of our clinical body of evidence. Both our post-market study of BEAT-HF and Batwire remain on track with our previous updates. In regard to BEAT-HF, We have been conducting this trial since early 2016, and here we are seven years later. We are looking forward to potentially unblinding the data and sharing the results with you before the end of this quarter. Looking ahead to 2023, we are very eager to accelerate the development of Parastim by utilizing the positive momentum we have built over the previous two years. While we are still very early in the commercial ramp and the market penetration, we are totally focused on the significant potential to provide treatment to as many patients as possible. And now, I would like to open the line for questions. Operator?
spk01: Thank you. As a reminder, to ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. One moment while we compile the Q&A roster. Our first question will come from the line of Robbie Marcus with JP Morgan. Your line is open.
spk09: Oh, great. Thanks for taking the questions. Maybe first, You know, the cash burn is going to be, it looks maybe a bit higher than last year, based on the sales and OpEx guidance. And you talk about a pathway to profitability without further capital raises. How important is a positive readout from Beach AF to getting to that target? And any timeframes in terms of revenue or years out that we could be thinking about cash flow profitability? Thanks.
spk04: Hey, Robbie. Thanks for the question. So one thing that we've been consistent on is the model that we've built is under the assumption that we get a neutral readout from the morbidity mortality trial. And that's not based on us being pessimistic about the results. It's just us taking a conservative approach. And so when we say that we think we still have enough cash on hand to reach cash flow break-evening comes with that assumption that morbidity mortality is neutral. We haven't yet drawn a line in the sand for when, publicly, when we're going to reach that cash flow breakeven point from a run rate perspective. But we do expect this to be the year where we see that cash burn start to flatline to be similar to the burn that we saw in 2022. And then from there, starting to see the overall burn start to drop on a quarterly basis.
spk09: Great. If I just want to dream big and say it is a positive trial, how important has or how big a barrier has not having a mortality benefit been to driving physician adoption? And, you know, if it does have a positive, do you think we should be thinking more like a rapid improvement in adoption following or is there still... you know, would it have to wait for FDA labeling? So maybe a little time afterwards.
spk03: Hey, Nadim here. So thanks for the question, by the way. Listen, when we started this trial in 2015, and 2016 started enrolling it, we powered it to win it, right? So we're still hopeful that the data will be clear-cut, simple yes answer to all of the questions below. That said, It's the real certainty here is the time it takes to get the word out. First, we'll probably, if there is a meeting, we'll do the announcement of the results during the medical meeting. But if there isn't one close by in terms of time, we don't want to sit on the data for too long. So we'd like to get it out as soon as possible. So we may end up doing... basically a next event where we'll invite you and other people who wants to listen in and we'll present ourselves the data, but that doesn't get it. So we'll have to wait for that medical meeting and do the presentation. There'll be a symposium or later. Baker after that, you also heard those. One is the FDA labeling that would allow us to market the data. And the second is the publication of the, surprisingly, FDA has been faster than most journals. The median time to publish a manuscript is a month. So those are the uncertain elements that would make me hesitate to say, yes, we will see a pickup in 2023, but a pickup in sales will happen in 2024. But based on your previous question, if the data is positive, we may decide faster after So paradoxically, we may burn cash a little bit faster earlier to funnel that.
spk09: Got it. Okay. Just last quick one for me. Is this something you're going to try and submit for a late breaker at ACC, or do you think you'll miss the date there? Thanks a lot.
spk03: Yeah, thanks for the question. We don't know yet.
spk09: Got it. Okay. Appreciate you taking the questions.
spk03: Thank you. If you're still listening, the ACC deadline for late breaker has passed. And that's why we don't know. We don't know if the data will be ready by the end. We are blinded, number one. And if we are, if they would accept us even after the deadline. Thank you, Ravi.
spk01: Thank you. One moment for our next question. And that will come from the line of Matthew O'Brien with Piper Sandler. Your line is open.
spk06: Afternoon. Thanks for taking the questions. I don't know, Nadeem or Jared, which one of you this is for, but I don't want to overstate this too much, but when I look at the unit number in Q4 versus, you know, the number of active senators that you had the last, you know, in Q3 and even in Q2, that productivity rate is down somewhat here in Q4. So can you just talk a little bit about why that's the case and then the confidence and why those metrics improve so steadily, especially even in Q1 and all the way throughout 2023? Yeah. Hi, Matt.
spk04: This is Jared. I can take that one. So as we look to the productivity for the accounts that we saw throughout 2022, Part of this was driven by the success on the addition of new accounts, driving the overall average productivity down. We've said early on that right when an account starts, we see them treat one or two patients and then they push pause for a period of three, four, five or six months. They check out the results from a reimbursement perspective, but then also as to how the therapy is going with or doing with their patients. After they see that, then they start to pick up the pace on their own productivity. So the longer they're with us, on average, the more patients they're treating. So we still have confidence that the longer these accounts stay with CVRx, they're going to treat more and more patients based on the data that we've seen and collected over the last three years. But I think the challenge we're facing over the last couple of quarters is that we've exceeded expectations on the number of accounts we were expecting to add, which just drives that overall productivity rate down because of the newness of those new accounts.
spk06: Got it. Makes sense. So just to put a finer point on it, just because you're up 15 and 20 active centers in Q2 and Q3, respectively, you know, that's the reason why that metric's down a little bit. And you're not seeing any change from trendline as far as utilization among those accounts as we're kind of, you know, exiting that six-month window.
spk04: Yeah, that's correct. Yeah, we're still seeing the centers that have been with us for a couple of years doing more than the centers that have been with us between one and two years. And they're doing more than the centers that have been with us less than 12 months.
spk06: Got it. Okay. And then, you know, we can get into margins and all the other stuff, which are positive updates, I guess, later. But the other question I did have was really on the DTC campaign. It seems like there's a lot of patients out there, and I know it's just a pilot study, but what are you seeing as far as running some of those studies, getting in front of patients that could be good candidates for this, and then transitioning them all the way through to potentially getting an implant?
spk03: Yeah. Thanks for the question. Why we kept it as a pilot still for a little bit longer is to understand exactly those questions that you're asking. They have no idea what form of heart failure they have. If they have an ICD or a CRT, they think they have a pacemaker. And I'm over generalizing. It's a disease that's harder to characterize. And when you look at our incidence rates that we calculated, you might get 500,000 new patients every year. That's about 4% to 5% of the heart failure patients overall. So it's a small percent of the patients. It's a game of numbers, and we track every single click, every single patient. When they provide us the information, we try to get as much as possible. Medical condition, as much as we are allowed to know, And if they're seeing their own physician versus seeing a heart failure specialist, two paths diverge. And if the heart failure specialist they're seeing happens to be on a site where we are already activated, as well, there is a diversion. It will go much faster. On the other hand, much slower. So it's all of those uncertainties, Matt, that keep this for the time being as a very interesting one. Nationwide across all centers.
spk06: Got it. Thanks so much.
spk03: Thank you.
spk01: Thank you. One moment for our next question. And that will come from the line of Margaret Cazor with William Blair. Your line is open.
spk02: Hey, good afternoon, everyone. Thanks for taking the questions. You know, just because VHF obviously is a short-term catalyst, I was just curious if you can walk us through any commercial or marketing changes that you would make based on, you know, let's call it three scenarios where, you know, the first is positive on morbidity, mortality, or on all events, you know, maybe a more gray area of a numerical improvement in mortality, but not on events. And then, you know, a third of maybe a less good morbidity outcome or whatever gray area, you know, that would be less good that you would look at. How would that change your behavior, I guess, relative to the guidance that you have?
spk03: Thank you, Margaret. Thanks for the question. Of the three scenarios that you mentioned, let's start from the most negative to the most positive. The most negative, the data is neutral. There is no benefit. Our plan is built on that scenario. As Jared just mentioned earlier, it's not that we don't believe that we will win. It's just, you know, I would like to establish a baseline that is conservative and consider all of the positive news as upside. If it's positive, trending positive, but not meeting the endpoint itself, then probably there'll be no change in our marketing and the sales strategy. Now, if it's a clear-cut positive where we met the most actively motivated endpoint and that FDA will give us the labeling that this device improves heart failure's outcome, then it is possible that Jared and I, with the approval of our board, we may decide to accelerate the in our sales and marketing effort in the United States. And when that would happen, it will take time. You know, you don't think it's adding territories. You have to identify the talent, hire them, train them and so forth. So that ramp will accelerate, but you will not see it overnight. I answered your question.
spk02: That was great. And I guess parroting further on that, so the existing accounts who already have a good sense of training and patient use and history with BarrowSTEM, have you talked to them about what their expectations are for the trial and how they might change their utilization once the data is announced? I'll also make one more and walk us through how they would view their TAM opportunity changing should one of those more positive scenarios come up.
spk03: It is a question, and now I wonder if I should have spoken with some physicians about this. Number one, we instruct our sales force to be super careful and stick with FDA-approved labeling. So that's why they do not engage in speculative discussions regarding outcomes. However, I could do this and explore that from a getting feedback perspective. That said, there is one area where our time will increase if we hit the end point. When we negotiated the current labeling with FDA back in 2019, FDA was very clear that we have not met yet the mortality morbidity because it was not what we are blinded for. And PRT devices, when they are a class one indicated, so QRS above 150 and the presence of a left bundle brain block, they have a mortality morbidity benefit. FDA did not want physicians to prescribe our devices in those situations. So that's why in our calculation of the total addressable market, we excluded patients who are eligible actually indicated for a CRT treatment. I believe that if we hit the mortality rate endpoint, I know that we will ask FDA to remove that exclusion. And I believe that FDA will accept the exclusion because we should then let the physician decide what therapy is more appropriate for their patients. And the labeling would allow us then for those patients who are indicated for a CRT device. So that will increase the total addressable market. It's a little bit to the extent of how much, Margaret, but at the right time, probably during the discussion about the results, I'm speculating here, but I believe we'll be ready with the updated numbers of the total addressable market at the same time.
spk02: Thank you, Juan. Great. That'd be fantastic. Thanks, guys.
spk07: Thank you.
spk01: Thank you. One moment for our next question. That will come from the line of William Plovanek with Canaccord. Your line is open.
spk08: Great. Thanks. Good evening. Thanks for taking my questions. A lot of them have already been answered, so I think I'll stick with some guidance and P&L stuff. You know, as you talked, you gave us the rep cadence you expect. In terms of the new account cadence, you know, would you expect that to stay the same, or are you shifting more to a go-deep strategy?
spk04: Hey, Bill. This is Jared. I can handle that one. So, from an account perspective, last year we were talking about adding high single digits on a quarterly basis throughout 2022. This year, we're expecting that to be in the range of about 10 to 12 new active implanting centers added on a quarterly basis as we march through 2023. And then there is going to be a bit of work done by the account managers to really start digging a little bit deeper and work in the referral pathway for those centers that are already active. So the centers that have been around for 12 or 24 months trying to go a little bit deeper, reach out to more of the referral cardiologists along the way.
spk08: Okay. And that kind of ties into the DTC question. And I think you kind of alluded to the fact, and I want to make sure I heard that right, is this more of a efficiency in terms of spend that you're trying to titrate and find out what is the most efficient in terms of getting a patient and converting them all or getting a lead and converting it through a patient? Is that where a lot of the focus on the DTC is today?
spk03: Bill, this is Nadim, by the way. Thank you for this question. It's an excellent question. Yes. You know, direct-to-consumer awareness campaigns that medical device companies did 20 years ago are very different from what we are doing today. Think about it. What they did back then, putting TV ads, was an open-loop system. What we're doing is a closed-loop system. we favor channels where we have traceability of every single click and every single patient and every single patient who saw the ad and converted. So we know all of those metrics at every single stage of the game. And the visible tip of the iceberg is the marketing campaign itself. 90% of the work is what happened behind the scenes to take those Consumers who saw the ad all the way to becoming candidates, or not becoming, to identifying if they are candidates to basically offer them possibilities and contacts of sites that are doing the procedure. So cost for every single one of those campaigns is very closely tracked and monitored almost on a daily basis. And we want to optimize it. we're not in the business right now of throwing money and creating awareness. This is not what we're doing. We're paying money where we believe that those money would lead to X number of patients who are, you know, and that equation should be profitable for us from this. That's what we're trying to explore. As an example, we added a new channel two days ago and we'll be testing it for a few weeks, you know, different iteration and see if it's, as profitable, more profitable, or less profitable than other channels we're using. And that's what we're trying to do here, trying to figure out different geographies, different type of sites, different type of advertisement, different channels, you know, between social media out there. And you do not advertise on Facebook the same way you do it on Instagram or TikTok or Twitter and so forth. So it's a big look. Our team is doing a phenomenal job. We're so excited about it.
spk08: Okay, good. And then quick, Jared, the 1.136 gain in the other, that's a little, you know, it's kind of a big number. Just curious what that was. And then just, you know, you've kind of went through it with Margaret, but in like, as simply as possible, what would you define as positive? What would you define as neutral? And what would you define as negative for the BDHF outcomes? And I know that's hard to do, but I think for investors, you know, if you could sum it up, like where are those kind of break points and how should we think about it? Thanks.
spk04: Hey Bill, I'll just on the first piece of it. I mean, the biggest chunk that's fallen into that other expense net bucket is, is the interest income that we're seeing from the cash balance that we have at this point in time. So that's kind of the biggest number there. Nadim, I'll let you cover the second piece.
spk03: Yeah, regarding the second piece, you know, in statistics, there is a p-value that you've identified to ensure that the trial has a type 1 error less than a certain percentage, right? So what FDA wants to know is whether you achieve those results as a fluke by chance or whether the observation is at the end of the reality. What I consider to be positive is if the primary endpoint met the statistical relevance that FDA is looking for. I would then say it will be in between, you know, if either the mortality is trending close to that point but not reaching it, or if other pre-specified, prioritized endpoints that we have previously agreed with FDA to analyze with statistical relevance. Why do I say so? Usually, when you're designing a trial for approval, you select an endpoint, FDA approves the endpoint, and if you meet the endpoint, you win. If you don't meet the endpoint, you lose, and that's the end of the game. What we have seen over the past 20 years is medical devices, it's a little bit more complicated than this. And FDA has to rely on the totality of evidence before they issue a judgment on whether the device is approved or not. In our case, our device is already approved. The benefits outweigh the risk, according to FDA. So what you're looking here is what does the device do in other elements that FDA would allow us to tell physicians that yes, the device is approved. And that's why it's a little bit more complicated than the usual situation. And even if we don't meet the primary endpoint per se, but we're trying to meet another secondary or ancillary endpoint, we still believe that there is a net net positive, not as positive as meeting the primary endpoint, but positive above our base case right now.
spk07: Thank you.
spk01: Thank you. One moment for our next question. That will come from the line of Alex Nowak with Craig Hallam. Your line is open.
spk07: Okay, great. Good afternoon, everyone. And perhaps I missed this, but can you expand on what is happening in the background, collecting all the morbidity data to move the readout from the first half to first quarter? You must be seeing something or hearing something to give you that confidence it's going to come this quarter rather than more in the first half of the year.
spk03: Hey, Alex, this is Nadeem. Nice hearing from you. It's actually not the data, but the rate of collection of the data and the rate of monitoring of the data. So we're just identifying the trend of monitoring of sites to ensure that we will have all of the data monitored as required by FDA before we unblind the data. And based on the trajectory we see, we are able and were able to narrow the timeline for the unblindings Now it's a very strong likelihood that this would happen in Q1, not in Q2. Okay, understood.
spk07: Okay, understood. That makes sense.
spk03: You're all good. What do you think about the rate of new center ads in 2023?
spk07: You more than doubled that number. in 2022. I'm just going to throw it out there, double the number again in 2023, or what are you thinking about what the ramping sales team can do this year?
spk04: Yeah, Alex, maybe I'll just kind of baseline on that guidance again. So for the U.S. heart failure business, the midpoint of the range, the expectation is that we'll be seeing ads of around 10 to 12 active implanting centers on a quarterly basis going forward. continuing to see those longer term accounts continue to ramp up the productivity level, similar to rates we saw in the past. And then as I just looked to the hypertension business in the U.S., it's still flat, right? It's a set patient population. And then just one more piece on the European side of it. We still haven't necessarily cracked the code over there at this point. And so our base case, the middle of the road of the guidance is that it would stay consistent at around that million dollars or so per quarter. We saw a bit of a uptick there in the fourth quarter, but some of that was distributors stocking up some shelves, shelf units there for the first half of 2023. So we don't expect that to be repeated here in the first quarter. So overall, the vast majority of that growth coming from the U.S. hard failure business, but most of that revenue is coming from those centers that have already signed up, have already been activated in 2022. and then adding that 10 to 12 per quarter going forward.
spk07: Okay, understood. That makes sense. And maybe on that last point, what do you need to happen for Europe to really ramp? Is it just you need to put a little bit more focus on it? You're just focusing too much on the U.S. for obviously good reason. Is it a reimbursement dynamic? Just how are you thinking about Europe?
spk03: Alex, it's all of the above. From a first perspective, We're really not in Europe. We're in Germany and a couple of other countries. In regards to Germany, we have a ZE code from a reimbursement perspective. A ZE code is kind of the middle layer. It's not as low as you knew, but it's not as good as DRG. One of the constraints about ZE codes is that the hospital has to preach procedures at the beginning of the year with their payers. But even if they pre-negotiated it, they could do the procedure, they can still be pinged after by an entity called the MDS that is made of medical auditors who would come and audit sites. And that kind of scares us of engaging in procedures that are not yet a DRG or are not yet in the guidelines. And we are neither. And because of this, we have not been in Germany right now, waiting until we have more data and do more advocacy and education in regard to getting in the guidelines in Europe. And it's a chicken and egg. To get a DRG, we need a certain number of units per year. You quote about 1,500 procedures. We have a device that's a high price, low number of units, as I've mentioned in previous questions. And because of that, it's harder to get 1,500 units in Germany to get into that DRG examination mode. And all of the above that we have not yet decided to invest heavily in Europe. Just as a comparison, we have more in our marketing team than we have for our entire team in Europe right now. It takes, you know, from an education perspective, physician education, patient education, and direct-to-consumer marketing, the physician-directed marketing team, and so forth. It's a large effort that we're doing in the U.S. right now to duplicate that just for Germany, in Germany, and we don't have the volume to justify being able to do it. And again, it's a chicken and egg. We have to decide to do it and break that loop, but right now our focus is in the U.S. Have I answered your question, Alex?
spk07: Yes, you have. That makes total sense. Really appreciate the update. Thank you.
spk03: Thank you so much.
spk01: Thank you.
spk03: And, guys, operator?
spk01: I'm showing no further questions in the queue at this time. I would like to turn the call back over to you, Mr. Yard, for any closing remarks.
spk03: Excellent. Thank you so much, operator. And thanks, everyone, again, for joining us for our fourth quarter earnings call. We appreciate your interest and we look forward to updating you on our progress during our next update. Good night.
spk01: Thank you all for participating. This concludes today's program. You may now disconnect.
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