CVRx - Q4 2023

Transcript

Operator (participant)

Greetings, and welcome to the CVRx Fourth Quarter 2023 Earnings Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce Mike Vallie, Investor Relations for CVRx. Thank you. You may begin.

Mike Vallie (Investor Relations)

Good afternoon. Thank you for joining us today for CVRx's Fourth Quarter 2023 Earnings Conference Call. Joining me on today's call are the company's President and Chief Executive Officer, Nadim Yared, and Chief Financial Officer, Jared Oasheim. 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, Nadim Yared.

Nadim Yared (President and CEO)

Thank you, Mike, and thanks to everyone for joining us. I'll begin today's call by providing an overview of our fourth quarter performance, followed by our operational update and a review of our financial results by our CFO, Jared Oasheim. Then, I will conclude with our thoughts for the rest of the year before turning to Q&A. We are immensely proud of the achievements of our team in 2023. It's been an important year for CVRx, marked by significant progress in all our strategic initiatives, which have driven increased adoption and utilization of Barostim. This is reflected in our worldwide revenue, which has shown substantial growth, primarily attributed to the impressive 97% annual expansion in our U.S. heart failure business. As we wrapped up 2023, we did so on a strong note, showcasing consistent and effective execution across various aspects of our business in the fourth quarter.

This underscores our team's skill in accelerating the adoption of Barostim through our commercial and marketing efforts. Now, let's dive into the details of our performance. Starting with the review of the quarter, worldwide revenue was $11.3 million, a 58% increase over the fourth quarter of 2022. This was primarily due to the execution within our U.S. heart failure business. The increase was primarily driven by continued growth as a result of the expansion into new sales territories and new accounts, as well as increased physician and patient awareness of Barostim. Turning to an update on our operational progress during the fourth quarter. As a reminder, our focus areas for 2023 were the continued expansion of our commercial infrastructure and the expansion of our clinical body of evidence.

Starting with the expansion of our commercial infrastructure, we've grown our commercial reach by adding three new sales territories in the United States, as expected, bringing our total to 38. We continue to add high-caliber talent, which we believe is due to the enthusiasm around Barostim in the markets. Additionally, we've been making continued and consistent headway with our marketing efforts, including our direct-to-consumer and patient education programs. As we press forward, we continue to expect refining these initiatives to drive awareness among both patients and healthcare providers. Shifting to our second focus area, which is the growth of our clinical evidence, which has driven both reimbursement and regulatory progress. In November, the Centers for Medicare and Medicaid Services, CMS, reassigned Barostim to New Technology APC 1580, with an average payment of $45,000, which went into effect on the first of January 2024.

As a reminder, in 2023, Barostim was under the APC 5465, with an average payment of $29,000, plus the transitional pass-through payment. We believe that this reassignment to APC 1580 will make the Barostim therapy more accessible for Medicare patients dealing with heart failure by simplifying the reimbursement landscape and ensuring fair reimbursement for facilities offering the procedure. In late December, the FDA approved expanded labeling for Barostim by revising the instructions for use for Barostim and incorporating key long-term clinical data from the BeAT-HF randomized clinical trial. The new labeling includes the following conclusion in the clinical section: In both pre-market and post-market phases, the primary safety endpoint was met and confirmed. The pre-market phase showed positive results across all effectiveness endpoints, indicating six-month improvements in 6-minute hall walk, quality of life, NYHA class, and NT-proBNP.

The post-market phase effectiveness endpoint of cardiovascular mortality and heart failure morbidity was not met, but additional post-market phase analysis, such as the win ratio and freedom from all-cause mortality analysis, suggested the favorable effect of Barostim therapy. The totality of six, 12, and 24 month data demonstrated symptomatic improvements for heart failure patients. All of this data is now included in the instructions for use and can be used by our sales team when educating physicians on our therapy. The updated indication statement in the Instructions for Use now specifies that Barostim is indicated for patients who are NYHA Class III or Class II with a recent history of Class III, despite treatment with guideline-directed medical therapies, who have a left ventricular ejection fraction of less than or equal to 35% and an NT-proBNP less than 1,600 picogram per milliliter....

Barostim delivers baroreflex activation therapy to improve patients' heart failure functional status, six-minute hall walk, and quality of life. As a result of these changes, we estimate that the U.S. annual market opportunity for Barostim has increased to include patients considered by physicians based on this new long-term safety and efficacy data, as well as our commercial experience, and to account for the new reimbursement assignment for Barostim. We believe the U.S. annual market opportunity is now $2.2 billion or 76,000 new patients annually, as compared to our earlier estimate of $1.4 billion or 55,000 new patients, representing increases of approximately 60% and 38% respectively.

I want to express my gratitude to all the patients, investigators, research teams, the executive steering committee, and FDA personnel who have supported our efforts in conducting this study over seven years, especially considering the challenges encountered during the COVID-19 pandemic. Looking back at 2023, it was a great year for CVRx. Throughout the year, we continued to support the growth of Barostim in the United States through our commercial and marketing efforts, underscoring the benefits that Barostim can provide to healthcare professionals and patients dealing with cardiovascular disease. The year wrapped up on a positive note, including the expanded Barostim labeling and CMS's decision to reassign Barostim to a new APC code. Before turning the call over to Jared, I want to address my decision to retire from CVRx.

While there is never a perfect time for a leadership transition, the recent completion of BeAT-HF, the expanded labeling, and the recent reimbursement decision, there is a window that now exists before the company embarks on the next phase of growth. I believe now is the right time to bring in a CEO who can build on the achievements of the company and steer CVRx to great success. I'm confident in CVRx's future, given the proven benefits of Barostim therapy, our strong commercial traction, and our outstanding leadership team. The board and I are committed to a seamless transition, and I will continue in my current role until a new CEO is appointed. The board has engaged a leading executive search firm to assist in this process. I'll now turn the call over to Jared to review our financials. Jared?

Jared Oasheim (CFO)

Thanks, Nadim. In the fourth quarter, total revenue generated was $11.3 million, representing an increase of $4.1 million or 58% compared to the same period last year. Revenue generated in the U.S. was $10.3 million in the current quarter, reflecting growth of 72% over the same period last year. Heart failure revenue in the U.S. totaled $10.2 million in the current quarter on a total of 330 revenue units, compared to $6 million in the fourth quarter of last year on 193 revenue units. The increase was primarily driven by continued growth as a result of the expansion into new sales territories and new accounts, as well as increased physician and patient awareness of Barostim.

At the end of the current quarter, we had a total of 178 active implanting centers, compared to 106 on December 31st, 2022, and 159 on September 30th, 2023. We also had 38 sales territories in the U.S. at the end of the current quarter, compared to 26 on December 31st, 2022, and 35 on September 30th, 2023. Revenue generated in Europe was $1 million in the current quarter, representing a decrease of 15% compared to the same period last year. Total revenue units in Europe decreased from 68 in Q4 of 2022 to 52 in the current quarter. The number of sales territories in Europe remained consistent at six for the three months ended December 31st, 2023.

Gross profit for the three months ended December 31st, 2023, was $9.6 million, an increase of $3.9 million compared to the three months ended December 31st, 2022. Gross margin for the current quarter increased to 85%, compared to 79% for the same period last year. Gross margin for the three months ended December 31st, 2023, was higher due to a decrease in the cost per unit and an increase in the average selling price. Research and development expenses for the current quarter were $2.2 million, reflecting a decrease of 26% compared to the same period last year.

This change was primarily driven by a $0.7 million decrease in clinical study expenses and a $0.6 million decrease in consulting expenses, partially offset by a $0.3 million increase in compensation expenses, mainly as a result of increased headcount, and a $0.1 million increase in non-cash stock-based compensation expense. SG&A expenses for the current quarter were $17 million, representing an increase of 21% compared to the same period last year.

This change was driven by a $1.7 million increase in compensation expenses, a $0.7 million increase in marketing and advertising expenses, a $0.4 million increase in non-cash stock-based compensation expense, and a $0.4 million increase in consulting expenses, partially offset by a $0.1 million decrease in D&O insurance costs and a $0.1 million decrease in professional fees. Interest expense increased $0.4 million for the three months ended December 31st, 2023, compared to the three months ended December 31st, 2022. This increase was driven by the interest expense on borrowings under the loan agreement entered into on October 31st, 2022. Other income net was $1.1 million for each of the three months ended December 31st, 2023, and 2022.

Other income net consisted primarily of income on our interest-bearing accounts. Net loss for the current quarter was $9.2 million, or $0.44 per share, compared to a net loss of $10.5 million, or $0.51 per share for the same period last year. Net loss per share was based on 20.8 million weighted average shares outstanding for the fourth quarter of 2023, and 20.6 million weighted average shares outstanding for the fourth quarter of 2022. At the end of the fourth quarter, cash and cash equivalents were $90.6 million. Net cash used in operating and investing activities was $39.6 million in 2023. This is compared to net cash used in operating and investing activities of $43.4 million in 2022. Now, turning to guidance.

For the full year of 2024, we expect total revenue between $53 million and $57 million. We expect full year gross margin between 83% and 84%, and we continue to expect operating expenses between $86 million and $90 million. For the first quarter of 2024, we expect to report total revenue between $11 million and $12 million. I would now like to turn the call back over to Nadim.

Nadim Yared (President and CEO)

Thanks, Jared. As we set our sights on 2024, I'm excited about the opportunities that lie ahead for CVRx and the continued expansion of Barostim. Our company is in a fantastic position to capitalize on the opportunities in front of us, thanks to our outstanding leadership team and the consistent execution of our strategic initiatives over the last two years. I believe CVRx is well prepared to continue to execute our strategic plans and drive sustained commercial growth. Reflecting on my 17 years as CEO, it has been an incredible experience and a true honor. I am proud of what we have accomplished and believe the future for CVRx holds immense promises. Now I would like to open the line for questions. Operator?

Operator (participant)

Thank you. Ladies and gentlemen, at this time, we will be conducting a question-and-answer session. If you'd like to ask a question, you may press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. Our first question comes from the line of Margaret Andrew with William Blair. Please proceed with your question.

Margaret Andrew (Partner and Medical Technology Analyst)

Hey, good afternoon, guys. Thanks for taking the questions. And Nadim, you've heard my comments at JP Morgan, but I'll just say them publicly. Obviously, it's been a pleasure to know you, and glad to have seen CVRx become what it is today. Maybe just to start out with, you know, you guys are coming off an exceptional year of 70%+ growth overall, you know, 95% of U.S. heart failure, you know, in U.S. heart failure. And yet, you know, you kind of look at the first quarter, and you're at $11 million-$12 million. So maybe just walk us through the assumptions within that. What are the conservative pieces that you guys used to drive to that guidance range? Thank you.

Jared Oasheim (CFO)

Hi, Margaret. This is Jared. I'll, I'll take that one. Maybe Nadim can add some color later. So when we put together our guidance, we're looking at, you know, how we've been growing the number of territories over the last few quarters, and also how the additions for new active implanting centers have been coming on board, and then also taking into consideration the utilization we've seen from those centers as they get more and more experienced. So after taking all of that into consideration, we came out with the guidance for Q1 of $11 million-$12 million. Again, seeing a step up from what we delivered in the fourth quarter of 2023. The other thing I'll just talk about a little bit is seasonality. We...

It's not something that we've seen historically at CVRx, but we have seen other companies that have gone through a similar ramp that we have, that start seeing seasonality play a factor as you go into Q1. Again, I don't think we took that into consideration here, for the first quarter guidance, but rather just trying to set the bar at a level that we think we can go out and deliver, in this first quarter.

When I think about the components of being able to hit the full year guidance, the $53 million-$57 million that we had talked about, something we talked about at the JP Morgan conference was really towards the low end of that range, we're targeting adding about 14 new active implanting centers on a quarterly basis, and at the high end, targeting adding about 18 new active implanting centers on a quarterly basis. And then from an ASP perspective, in 2023, we were seeing results of about $31,000 for an ASP in the U.S. heart failure side.

And as we go into 2024, the range we're looking at is around $29,000-$30,000, thinking that as we continue to see more and more volume from our implanting centers, that we may see some pressure on pricing and see the request for some bigger rebates. And then from a territory perspective, we've been adding at about three per quarter since the IPO. We feel like that is a pretty good pace to continue on, and that's what was factored into that $53 million-$57 million guidance for 2024.

Margaret Andrew (Partner and Medical Technology Analyst)

Okay. So, you know, if we take that into context, and I appreciate your comments on kind of the ramps and so on. But, you know, you guys are armed with, you know, both a better reimbursement rate as well as, you know, the new clinical data. So I know it's early, maybe there hasn't been a big clinical conference at this point in time yet for you guys to start more actively presenting on that. But where are you, I guess, in terms of sales force training, as well as putting together an educational education program, excuse me, as it relates to pushing the new label?

Nadim Yared (President and CEO)

... Yeah, Margaret, I'll take this question. So first, thank you for your previous comment. I am going to miss these interactions for sure when I retire. I'm not there yet, as we're, you know, committed to the transition in here, as long as how long it takes. I used to remember that I resented some of the difficult questions that you guys would ask me, but with time, I understood all of the hard work that you put into this, into understanding our business. And I, you know, I end up enjoying these interactions. To answer your questions, yeah, now that we have... In between Christmas and New Year's Eve, we got the approval from FDA to be able to communicate.

All of our efforts right now in January has been about how do we get out and educate patients and physicians. And we have our global sales meeting actually next week to make sure that all of our sales force is trained and equipped with all of these tools. So this is an ongoing process right now to get the word out to patients, and providers, and payers about the new data. We're very excited about this next phase.

Margaret Andrew (Partner and Medical Technology Analyst)

Okay, great. And just one last question for me. You know, saw the $7 million burn, you know, on a cash rate, this past quarter. How should we think about that going forward? You know, are you guys gonna step on the gas pedal in terms of expenses with the label and et cetera? Are you gonna continue to try to, you know, maintain that cash burn around $7 million or better? Thank you, guys.

Jared Oasheim (CFO)

Yeah. Thank, thanks for the question. Yeah, we gave guidance around spend on OpEx, seeing an increase there to get us up to about $86 million-$90 million. The vast majority of that growth in spend from 2023 to 2024 will go into the sales and marketing organization, specifically in the US. So we're gonna continue to be opportunistic, where we can to invest in the business to be able to help more and more patients gain access to this therapy. And then I think it's a bit of a wait and see, right? Let's see how physicians, let's see how patients react to the new clinical data. If the new payment code is a little bit easier for centers to come on board at a little bit of a faster rate, then we'll consider making some additional investments.

But the guidance we put out, I think, is being a little prudent in making sure that, you know, we're able to maintain that cash burn at or below the levels we've seen historically. Overall, we believe the trend will continue where that burn will come down, so that we can use the cash we have on hand to get to cash flow breakeven without needing to go out and raise more money.

Operator (participant)

Our next question comes from the line of Robbie Marcus with JP Morgan. Please proceed with your question. Our next question comes from the line of Matthew O'Brien with Piper Sandler. Please proceed with your question.

Matthew O'Brien (Senior Research Analyst)

Afternoon. Can you guys hear me okay?

Jared Oasheim (CFO)

Yes.

Matthew O'Brien (Senior Research Analyst)

Oh, fantastic. And, Nadim, yeah, best of luck to you in the future. Hopefully, it takes a long, long time to find a replacement for you. I say that selfishly. So just two questions here, and I'll ask them both together. They're a little bit, you know, it's long-winded, so forgive me. But just on the pricing side, Jared, you know, are, are we assuming pricing essentially flat versus 2023, or can you take that up given how healthy that code is? I guess I'm not sure why it would go down. And then the second piece is just on the... You know, as I look at the guidance and I look at where the stock is trading in the aftermarket, it's down a little bit. I think it's on the guide.

It's assuming a pretty meaningful slowdown in growth in terms of units sold this year. It's actually, it's actually about the same number of units at the midpoint of the range, per the math that I have anyway. But, you know, seems like, you know, expanded label and more centers and everything else like that, the absolute number of units should go up this year versus what you did last year in terms of growing total number of units. So why would that, why would that be the case? Why wouldn't it be even faster, and why wouldn't growth, you know, in the U.S. be a little bit more healthy, given all these tailwinds that you're seeing? Thank you.

Jared Oasheim (CFO)

Yeah, hey, Matt. On the pricing piece, I think that one's a little bit easier to cover first. So we had talked about U.S. heart failure average selling prices being around $31,000 in 2023, and setting expectations with this guidance to be around $29,000-$30,000. I will add, you know, we have also seen a list price increase in 2024 for Barostim, and so there are opportunities for the price to go up as we go into 2024 from what we saw in 2023. But our assumption from the beginning was that as we continue to see more and more volume, we are gonna continue to see more and more pressure from our customers to see bigger discounts and bigger rebates.

So I think we're just being a little prudent on that price expectations at the beginning of the year to see how it actually plays out with this new code for customers throughout 2024. So I'm sure we'll continue to monitor what that average is coming in at here in the first quarter and the second quarter, and then be able to, you know, make some updates if it's necessary for the rest of the year. Then for the guide, as far as pure units, yes, we will continue to see growth in the number of patients that are getting treated between, you know, from 2023 to 2024. Seeing a, you know, like I said, a slight downtick in that average selling price.

When we come out at the beginning of the year with our guidance, you know, we want to feel confident being able to go out and meet these numbers. So when we put together the model, we were looking at productivity staying flat because we were able to achieve these levels of about two revenue units per active implanting center per quarter throughout 2023. So, you know, that's a number that we've been able to achieve in the past, and that's a number that we thought was pretty good to set for expectations as we move into 2024. Then same thing on the new center adds when building out the model.

You know, we've been able to deliver about 18 new center adds on a quarterly basis throughout 2023, and I think when you factor that into the model, that's towards the top end of that guidance for the US as well. One thing I'd just like to address as well is Europe, where we've been seeing a flat quarterly revenue of about $1 million for the last, you know, four to six quarters. And so when you look at the overall growth rate for revenue worldwide, that does hinder us a little bit with expectations that there is no growth, just hoping for a flat result from 2023 to 2024 with that European revenue. Hope that answers your question.

Matthew O'Brien (Senior Research Analyst)

Yeah. Understood. Thank you so much.

Operator (participant)

Our next question comes from the line of Robbie Marcus with JP Morgan. Please proceed with your question.

Robbie Marcus (Managing Director & Senior Analyst, Healthcare)

Great. Thanks. This time I'll, I'll not hit the hang up button instead of the talk button. First off, Nadim, well, congratulations on the retirement. We'll miss you. For the question, you know, I was wondering if you could just walk us through what the change, if any, in hospitals has been since the reimbursement has been finalized end of last year. Has it-- have you seen any easier times getting into hospitals, talking about reimbursement, getting doctors excited, initiation of, you know, potential new programs at hospitals? Just any change in the sentiment out there.

Nadim Yared (President and CEO)

Robbie, thank you first for your nice words and, but great question. The answer is going to be qualitative at this stage because the code just entered, right, January first, and we are now a couple of weeks, and we're not commenting on the results in January at this stage. But qualitatively, we expect it to help, particularly with the site activation, which would lead to the possibly in the future, you know, the less delay between the first two patients they do at a site and patient number three, four.

I don't know if you recall, but earlier, when after we did the IPO, we tried to explain that phenomenon that we were observing, and we kept observing over the past couple of years, which is when a site becomes an actively implanting centers after doing their first one or two implants, we notice a pause of three, four months before they start considering patient number three, four, and five. That pause was driven by two elements. One is seeing the effect of the device on their own patients. But second, most importantly, and we did not understand the impact of that, was understanding the payment level because the TPT is still seen as an obscure way of getting payment to hospitals. The calculation formula for TPT is very complicated, and very few administrators at hospitals understand how the accounting work for that TPT.

So after doing a couple of patients, they wanted to wait to see the payment coming back. So at least one of those two elements we expect would be alleviated by having a code with a simple code, simple number, just adjusted for the zip code, which is they understand how it works. So I cannot answer quantitatively yet. At this stage, it will be the answer, will be only qualitative, Robbie.

Robbie Marcus (Managing Director & Senior Analyst, Healthcare)

Great. Now that's helpful. And maybe as you think about balancing, you know, as you talked about in prior questions, balancing your cash burn with now, you know, the updated label and the finalized reimbursement, how are you thinking about balancing OpEx spend to drive sales rather than just cash preservation? You know, what goes into decisions? You know, why is the amount of OpEx you're spending the right amount? If you spent double it, do you think you'd be able to double your sales? Thanks.

Jared Oasheim (CFO)

Yeah. Good, good, good question, Robbie. Right. I mean, the simple question is, you know, have we proven the model, right? And I think we have two more years of experience after the IPO, showing that we've been able to add three territories on a quarterly basis while continuing to see that overall productivity per territory increase as that number continues to grow. And, you know, as we see more feedback from customers after the new label from FDA and after the new code has come out, you know, we're gonna continue those conversations. As we see the results of those conversations and reactions from physicians and patients through our DTC campaigns, I think that's where we will continue to make some tests, right?

I think some of those investments are baked into the guidance that we gave of the $86 million-$90 million to start seeing, is there opportunities to continue to spend a little bit more? Because the goal at the end of the day for us is to help more and more patients. If we can do that at a faster pace while not diminishing our cash balance too quickly, I think we'll take advantage of it. But that, that's something that we'll continue to work on throughout 2024.

Robbie Marcus (Managing Director & Senior Analyst, Healthcare)

Great. Thanks a lot.

Operator (participant)

Our next question comes from the line of Bill Plovanic with Canaccord. Please proceed with your question.

Bill Plovanic (Managing Director of Equity Research and Medical Technology Analyst)

Great, thanks. Good evening, and thanks for taking my questions. I'm gonna start out with, you mentioned on just the list price increase in 2024. I could just... You know, there's always a big difference between list price and the ASP. Just kinda curious to what extent or the, if you could quantify that for us. And then just, you know, we're a bit surprised your R&D expenses come down a lot. How should we think about the OpEx spend in 2024 relative to 2023 as it relates to the SG&A versus the R&D? Like, you know, so in R&D, are there any major new projects kicking off that we should think about, or is this kind of the run rate for that going forward?

Jared Oasheim (CFO)

... Yeah, good, good questions, Bill. Thanks, thanks for the question. So on the list price, there was a 10% increase on the list price for the U.S. business. So in seeing an increase from a $35,000 list price up to $38,500. So that, that's where all of the contracting discussions will start as we move into 2024. And then, going down to the OpEx guide and the split between R&D and SG&A, as I mentioned earlier, the vast majority of that increase is going into SG&A. As you can imagine, we saw a bit of sunsetting of the BeAT-HF clinical trial as we went throughout 2023, and so that's driving some of that reduction as we march through 2023, and especially into the fourth quarter.

Seeing that trial close down, those expenses turn off, and, you know, we're able to reduce the overall spend in research and development. What we have going on right now, you know, we'll have some smaller projects within research and development, like our post-market registry, continuing to do some investigator-initiated research programs with different sites that are proposing them, through our program on our website. And then we continue to do some early work with designing the next clinical trial. Nadim has talked about this before, where we were admitted to an advisory program from FDA for one of our breakthrough device designations, specifically our ejection fraction above 35% patient population.

And so we'll continue to look at that trial design to see if we can get to a point where we feel comfortable that we, we can win the trial and not spend too much money, and decide at that point in time whether or not we want to kick it off. But at this point, that's not baked into the guidance in the spend for 2024.

Bill Plovanic (Managing Director of Equity Research and Medical Technology Analyst)

Okay. And then if I could also ask, since we're working the P&L here, is just on the gross margin. I'm trying to understand, the guide on the gross margin is 83%-84%. You've been solidly at 84%, or above for the past three quarters. What are the dynamics that would cause the gross margin to go down next year, especially considering you're likely to have stable to increasing ASPs and higher volumes?

Jared Oasheim (CFO)

Yeah, good, good question. So as we set the guide for 2024, we're looking at the two different components, right? The ASPs and the costs. First, on the ASPs, we've mentioned that the guide is assuming a reduction in that overall U.S. heart failure ASP from $31,000 down to closer to that $29,500 at the midpoint. So that can have an impact on the overall gross margin results for 2024. And then the second component is the cost. We've talked a lot about as we see the volume increase, we shouldn't see an overall trend of seeing that cost come down. So as we see production go up, the cost should come down.

However, you know, if we continue to buy components for these devices, we're going to have to go out and negotiate new contracts with new vendors at different times. And at that, those points in times, we may see a price increase for the components themselves, not necessarily as much focused on the labor and overhead pieces of that. So both of those factored into our decision to guide us at the 83%-84% for 2024.

Bill Plovanic (Managing Director of Equity Research and Medical Technology Analyst)

Okay, great. Thanks for taking my questions.

Jared Oasheim (CFO)

Yep.

Operator (participant)

Our next question comes from the line of Alex Nowak with Craig-Hallum. Please proceed with your question.

Alex Nowak (Partner and Director of Healthcare Research)

Okay, great. Good afternoon, everyone. Now with BeAT-HF done, FDA approval in hand, that's all wrapped up. Just holistically, where is Barostim going to go next? You know, there's a ton of potential, as you know, in the baroreflex stimulation. Does it make sense to spend clinical study dollars to go deeper into the left-sided indication, you know, the increase of the ejection fraction or change of the BNP requirements? Or does it make more sense to really go after a completely new indication?

Nadim Yared (President and CEO)

Alex, excellent question. So we spoke in the past that we believe that from the mechanism of action and some previous experiments, that the device could have applicability beyond heart failure. Particularly, we spoke about hypertension, chronic kidney disease, and arrhythmias. And in the past, FDA has granted us, based on previous clinical data that we submitted to FDA, two breakthrough device designation, BDD, one in heart failure with preserved ejection fraction and one in resistant hypertension. So when we considered both of those two indications, resistant hypertension and HFpEF, it was probably or likely that one of these two will be the second indication we go after.

Then when we got invited to be one of the 15 initial pilots that FDA started this year with a new program called the TAP, Total Lifecycle Advisory Program, TAP, that was limited only to breakthrough device designated indications for new products. We started working with FDA about the HFpEF indication. So this is the heart failure indication with ejection fraction above 35%. For us, it would make more sense to go after these indications for multiple reasons. One of them is the synergy in the sales and marketing efforts. The physicians will be the same, the call points will be the same. Even some of the direct-to-consumer marketing campaign would be the same, most of the education would be the same, and so forth. Is it a new indication?

I would say yes, because those two diseases are different, and if we are approved in EF above 35%, that would significantly and substantially increase the total addressable market of our therapy. So while we are excited about this opportunity, we are in the early phase of the design of the study. Part of the TAP program is the requirement to collect stakeholder input before we start the enrollment of the trial. So we need to collect input not only from the regulators and physicians, but also from patients, payers, guideline committees, and so forth. And we are in this process. We actually had a very constructive meeting last week during the Heart Failure Collaboratory with regulators, payers, patients, and key opinion leaders and medical societies as well, in one single meeting. So this is where we are right now.

On the question of when do we start this program, it's early to know how long it will take to design or finalize the design of the trial, and then the second question will be the question of spending that Jared was talking about in there for the, you know, the previous question that he got.

Alex Nowak (Partner and Director of Healthcare Research)

Okay, that's extremely helpful. Thank you so much. And Nadim, obviously, congrats on the retirement and getting the Barostim where it is today. You're obviously on the board. In your conversation with them about the transition that will take place here, is there still a plan for you to remain on the board? Any views you can kind of give there?

Nadim Yared (President and CEO)

Alex, thanks for asking the question. So, listen, at the end of the day, I will do whatever is needed in here to ensure that CVRx has the best and smoothest transition possible between me and the next CEO. So yes, I help the board in terms of the search. You know, we meet with the search committee on a daily basis to identify and look at all of the candidates, internal and external. And whether I stay on the board or not is not the point. The question is, what is the most effective way for me to be helpful, not only during the transition, but also after this transition, depending on what the board and the new CEO will need from me? Listen, this is my baby. I've been here 17 years.

I'm not going to drop it one day and forget about it. So it's in my best interest to ensure that I dedicate the time needed in here to ensure it's the smoothest possible transition. And whichever form that takes, I really, it's immaterial. Whatever the new CEO and the board want me to do, I will do.

Alex Nowak (Partner and Director of Healthcare Research)

Well, that's, that's good to hear. And then maybe just a quick question for Jared. Whenever we get a new code, hospitals always go through a transition process. So for the Q1 guidance, can we assume that there's a little bit of conservatism built in for hospitals going through that transition, where they might be a little more hesitant to buy just because they got to figure out the reimbursement dynamics again?

Jared Oasheim (CFO)

Yeah, yeah. Good, good question. You know, whenever we put out guidance, we're looking at a lot of different factors, right? And we're always being prudent to make sure that we can put out guidance that we're able to go out and achieve. And so I think we take all of those points into consideration when we put that guide together of $11 million-$12 million for the first quarter.

Alex Nowak (Partner and Director of Healthcare Research)

All right. Excellent. Thanks for the update.

Jared Oasheim (CFO)

Thank you.

Operator (participant)

Our final question comes from the line of Frank Takkinen with Lake Street. Please proceed with your question.

Frank Takkinen (Senior Research Analyst on Medical Device)

Great. Thanks for taking the question, and I'll echo everybody else's comments related to your succession plans, Nadim. Maybe following up on the question string related to balancing growth, aspirations, and cash burn. I think there was a comment at the end of that string related to if we elect to grow more aggressively, we'll think about the strategy to do so at that time. Can you maybe walk through some of the different areas you would think about prioritizing if you did elect to more aggressively invest? Is it faster headcount growth, more aggressive on AIC activation, direct to consumers? Maybe think about the or help us think about the prioritization if you did grow faster or attempt to grow faster.

Jared Oasheim (CFO)

Yeah. Hi, Frank. And just to reiterate, right, I think, you know, our plans are always to try and treat as many patients as possible, and we have a lot of people out in the field today with our current number of territories to be able to go out and help more and more of those patients. And so we think we're going to continue to see growth just from the team that we have out there today. Where could we invest faster, right? If we had an open checkbook, there's plenty of opportunities. Nadim talked in-depth about the new indications and how this is a platform technology, where if we were able to go out and run clinical trials and get approvals from FDA, it opens the door to a whole bunch of new patients that could benefit from this therapy.

In the more immediate term, yeah, I mean, it's all of those areas, right? It's do you invest more in, more sales reps out in the field? Do you invest more in DTC? And, the key thing for us is doing it in a thoughtful way, right? We don't want to just throw money at things and hope that it works. We're being very prudent on how we're utilizing our cash to make sure that there is no need to go raise more money. We can do this on our own without having to go do another financing. And if there is a decision to ever raise more money in the future, it's, you know, us being opportunistic because we've been able to prove out some of those additional tests that we've run as a business.

Frank Takkinen (Senior Research Analyst on Medical Device)

Okay, that's helpful. And then maybe just one more sticking with the commercial organization. As companies progress through this model, there's always an initial influx of onboarding new centers that are implanting the technology, and then as utilization catches up, sometimes you see a shift to incentivizing the sales force to more aggressively go after improving utilization, just given the leverage effects of doing that once you have a large network of active implanting centers. My assumption is you're still focused probably more on the activation of implanting centers, but maybe talk to how you think about that progression versus new centers versus eventually being more aggressive on pulling the utilization lever.

Nadim Yared (President and CEO)

I can, Frank, excellent question. So in our case, it's a little bit, a little bit different because when we activate a center, that's the implanting center, but the referral network is all around that center. So yes, we need to ensure that our sales force is focused on training and educating cardiologists in the community to send their patients to that implanting center. That's part of the market development that we do. So I'm not going to go into detail about incentive plans as we have the global sales meeting next week, and our sales doesn't know their sales plan, their incentive plan yet. But, I think I've given you enough hints about it. It's all about not only activating the implanting centers but also building the referral network around it.

So this is after, you know, we activate a center, they do their first few implants. Then the key here, the name of the game is get as many referring cardiologists around this hospital to send their patients to the hospital.

Jared Oasheim (CFO)

Yeah, and Frank, I'll just chime in, too. As I mentioned with the guidance, the expectation is to continue to add new centers on a quarterly basis as well, at a similar pace to what we had seen historically. So we're gonna, we expect to continue to see growth from both aspects. Number one, seeing new centers come on board. Number two, seeing those centers get more and more experience. And history has told us the more experience they get, the more patients they're treating on average, so seeing higher productivity.

Frank Takkinen (Senior Research Analyst on Medical Device)

Got it. That's helpful. Thanks for taking the questions.

Operator (participant)

That concludes our question and answer session. I'd like to hand it back to Nadim Yared for closing remarks.

Nadim Yared (President and CEO)

Oh, yeah. Thank you, operator, and thanks again to everyone for joining us for our fourth quarter earnings call. We appreciate your ongoing support, and we look forward to updating you on our next progress, on our next update, actually, next slide. Thank you.

Operator (participant)

Ladies and gentlemen, this does conclude today's teleconference. Thank you for your participation. You may disconnect your lines at this time, and have a wonderful day.