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spk10: Greetings and welcome to the CVRX Q1 2024 earnings call. At this time, all participants are in a listen mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star and then zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mike Valli. Thank you. You may begin.
spk04: Good afternoon. Thank you for joining us today for CBRX's first quarter 2024 earnings conference call. Joining me on today's call are the company's president and chief executive officer, Kevin Hikes, and chief financial officer, Jared O'Shine. 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, Kevin Hikes.
spk03: Thanks, Mike, and thanks, everyone, for joining us. I'll begin today's call by providing a brief overview of our first quarter performance. Then, since this is my first call as the CEO of CVRX, I'd like to share a summary of my background and tell you what I've been doing since joining the company in mid-February. I will then provide you with some of my initial observations on the business and a little more color on our quarterly performance. Jared will then provide a review of our financial results, and I will conclude with our thoughts for the rest of the year before turning to Q&A. Starting with an overview of our performance during the first quarter, total revenue was $10.8 million, an increase of 35% over the first quarter of 2023. This was below our guidance of $11 to $12 million. The lower than anticipated revenue was due primarily to the performance of our U.S. heart failure business, where there was some disruption within our sales organization at the time of the CEO transition, which led to decreased productivity and some Salesforce turnover. While stabilizing the team and returning active territories to full productivity will take some time, I'm encouraged that some of the early actions we have taken have led to solid performance in our US heart failure business in March. In addition, as I will discuss more fully later, we have made the decision to make a change in sales leadership. By way of background, I've been in the medical device industry for over 30 years, and most of my focus has been spent commercializing novel therapies around the globe. I began my career at Medtronic and spent 16 years there in commercial roles in the CRM, neuromodulation, and cardiac surgery businesses in both the U.S. and Europe. Subsequent to Medtronic, I served as president and CEO for a series of privately held early- to mid-stage high-growth companies, several of which were in the neuromodulation and cardiovascular fields. Many of these roles, both at Medtronic and subsequently, involved the introduction of novel therapies for the treatment of chronic conditions for which there were historically limited treatment options. The ultimate goal of these efforts was to move these therapies to standard of care. I learned through these experiences that reaching standard of care requires a rigorous assessment of the specific barriers to adoption and a systematic approach to addressing and eliminating each of them. Although I have only been in my current role for two months, many of the opportunities and challenges that I've observed here at CVRX are familiar to me. Later, I'll go into more detail about some of my early observations and our initial plans for addressing them. Apart from my operating experience, I've also served on a number of public and private company boards, including the board of CVRX, which I joined in December of 2022. While my time on the board provided me with knowledge of the business and market, I needed to get a deeper understanding to effectively lead the day-to-day operations of the company and to develop our long-term strategy. Upon joining CVRx, I began a series of listening tours with our customers and our commercial teams in the U.S. and Europe in order to understand the opportunities and challenges that we face driving adoption of barostem, as well as to gain a better understanding of future opportunities to leverage our therapy platform. I also conducted a systematic review of the company's operations to understand the stability and scalability of our business. My overwhelming takeaway after collecting this wide array of feedback is that BarroStim is a remarkably effective and highly impactful therapy for patients suffering from heart failure for whom there are extremely limited treatment options today. I also validated my observation that CVRx is a well-run company with a team of highly committed and patient-focused employees. My conversations with over 50 heart failure physicians at two recent international heart failure congresses and numerous visits in the field have cemented my belief that BarroStim can indeed fill the gap that exists in today's treatment continuum for heart failure and that we are only scratching the surface of the population of patients that we can help and the value that we can create. My conversations with these physicians and advisors have led me to believe that in the near term, we need to more fully support our commercial efforts in our existing HF-REF indication. With last year's label expansion for BarroStim, we now have a $2.2 billion annual market opportunity in the U.S. alone, and we've only penetrated 2% of this market. This highlights the massive opportunity to drive increased adoption of BarroStim in the HF-REF indication, where we have limited device competition. Based on my initial assessment of the barriers of adoption for barostim, I have asked our team to explore the value and potential impact of increased investment in clinical evidence, therapy awareness, and patient access initiatives. Any investment in these areas will come from a reallocation of existing resources as we remain focused on keeping overall spending in check. I will be working with our team over the coming quarters with this in mind as we refine our go-to-market strategy. As noted, our first quarter revenue performance was below expectations. As a high growth commercial stage company, the effectiveness of our sales organization is critical. Based on my assessment of our sales team and the disruption that we saw in Q1, I've determined that a change in leadership is needed to maximize the opportunity in front of us. As a result, our senior vice president of sales will be departing the company. We have initiated a thorough search to identify a candidate who can scale this business to reach its full potential. In the interim, we have asked Paul Verastro, currently our Chief Marketing and Strategy Officer, to head up our sales efforts until the new sales leader is in place. Paul is a highly respected medical device sales and marketing leader with over 30 years of experience, including senior leadership roles at Guidant and Medtronic. Importantly, much of Paul's experience involved the introduction of novel therapies and technologies such as ICDs and CRT. Paul has been a key member of the CVRx leadership team for over three years and is highly respected by our sales organization and physician customers. It probably goes without saying, but I will actively support Paul in his interim role until our new sales leader is identified. In addition to my listening tour, I've spent significant time with the team assessing our go-to-market strategy. Based on my initial observations and my experience introducing novel therapies, we've identified three near-term priorities to move barostim towards standard of care. The first key priority is to increase awareness among clinicians and patients as to the appropriate role for barostim in the treatment continuum for heart failure. Building this awareness through comprehensive physician outreach and education will be crucial. The second is the need to further bolster the clinical evidence supporting the efficacy and safety profile of barostim therapy within the current indication. We are increasing our focus on the generation of robust post-market evidence within HF-REF. Finally, as with many novel therapies, we face potential hurdles related to coding, coverage, and payment, which can limit patient access in the short term. While we have been proactively addressing these issues, we will be making additional investments to facilitate patient access. To address these market development priorities, we are actively building out the leadership team with new roles specifically designed to drive initiatives in these areas. We believe that bringing in seasoned leaders to build out these core functions will help us reach more patients who can benefit from barostem therapy. The first of these roles is a chief medical officer. This role will spearhead our efforts to drive awareness and appropriate use of our therapy among clinicians. The CMO will guide comprehensive medical education, outreach, and guideline integration to drive our therapy towards standard of care. The second is a senior vice president of clinical affairs. This position will oversee the development and execution of our clinical evidence generation strategy including designing and optimizing a pipeline of robust post-market studies within the current indication. As you may have noticed, subsequent to the end of the first quarter, we announced the publication of the results of the post-market phase of the BEAT-HF trial in the European Journal of Heart Failure. This long-term data set will be an important input to our future evidence development plan. Lastly, the third role is a Senior Vice President of Patient Access. This role will be important in further expanding access to barostem therapy. You may have seen that we recently made progress in this area through the proposed inpatient DRG reassignment, which is expected to take effect on October 1st, 2024. The proposal has barostem mapped to a higher paying reimbursement code for inpatient care. The searches for these three key roles are well underway. We're seeking to fill these roles as soon as possible. With these leaders in place, we will be even better equipped to address the awareness, evidence, and patient access hurdles to widespread adoption. This increased near-term focus on commercialization in our core business does not mean that we will not pursue indication expansion and product optimization of the barostim therapy platform. My conversations with clinicians have highlighted the unique platform nature of our technology and the potential to help additional patient groups. We will carefully and appropriately balance this investment in the future with the significant commercial opportunity that exists today in HFREF. We will be conducting a thorough review of our R&D and clinical portfolios to narrow our focus on those select few high-impact projects that we believe will ultimately drive value for both the company and patients. We look forward to sharing the findings of both our updated go-to-market strategy and our R&D portfolio review with you later in 2024. On a related note, we've elected to stop enrollment in the BATWIRE trial. This change was not due to safety concerns, but rather due to the realization that many patient candidates elected the commercially approved procedure as opposed to participating in the trial. This suggests that the current procedure is widely acceptable to patients and physicians, and therefore not a barrier to adoption. We intend to continue following the patients enrolled in the BATWIRE trial until study completion. Overall, I'm tremendously optimistic about our technology and market opportunity and the strength of our organization. I have already started to implement changes in the business that will improve the execution in the near term. In addition, I'm in the process of working with our leadership team to develop our long-term vision and strategy for the business, which we look forward to sharing with you when our analysis is complete. Now, I'd like to turn the call over to Jared for a financial review.
spk05: Thanks, Kevin. In the first quarter, total revenue generated was $10.8 million, representing an increase of $2.8 million, or 35%, compared to the same period last year. Revenue generated in the U.S. was $9.8 million in the current quarter, reflecting growth of 42% over the same period last year. Heart failure revenue in the U.S. totaled $9.7 million in the current quarter on a total of 319 revenue units compared to $6.8 million in the first quarter of last year on 225 revenue units. The increases were 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 current quarter, we had a total of 190 active implanting centers compared to 122 on March 31, 2023, and 178 on December 31, 2023. We also had 39 sales territories in the U.S. at the end of the current quarter compared to 29 on March 31, 2023, and 38 on December 31, 2023. Revenue generated in Europe was $0.9 million in the current quarter, representing a decrease of 10% compared to the same period last year. Total revenue units in Europe decreased from 52 in Q1 of 2023 to 44 in the current quarter. The number of sales territories in Europe remained consistent at six for the three months ended March 31, 2024. Gross profit for the three months ended March 31, 2024 was $9.2 million, an increase of $2.5 million compared to the three months ended March 31, 2023. Gross margin for the current quarter increased to 85% compared to 83% for the same period last year. This increase was due primarily to a decrease in the cost per unit driven by an increase in the production volume. Research and development expenses for the current quarter were $3.1 million, reflecting a decrease of 11% compared to the same period last year. This change was driven by a $0.2 million decrease in non-cash stock-based compensation expense and a $0.2 million decrease in consulting expenses. SG&A expenses for the current quarter were $28.3 million, representing an increase of 84% compared to the same period last year. This change was primarily driven by a $9.6 million increase in non-cash stock-based compensation expense, a $2 million increase in compensation expense, and a $0.6 million increase in travel expenses. Approximately $8.4 million of the increase in non-cash stock-based compensation expense is related to the previously disclosed modification of stock options held by the former CEO in connection with his retirement in the first quarter of 2024. Interest expense increased $0.7 million for the three months ended March 31, 2024, compared to the same period last year. The increase was driven by the interest expense on borrowings under the loan agreement. Other income net decreased $18,000 for the three months ended March 31, 2024, compared to the same period last year. This decrease was primarily driven by a lower cash balance in our interest-bearing accounts. Net loss for the current quarter was $22.2 million, or $1.04 per share, compared to a net loss of $11.4 million, or $0.55 per share, for the same period last year. Net loss per share was based on 21.2 million weighted average shares outstanding for the first quarter of 2024 and 20.7 million weighted average shares outstanding for the first quarter of 2023. As of March 31, 2024, cash and cash equivalents were $80.1 million. Net cash used in operating and investing activities was $11.8 million for the quarter ended March 31, 2024. This is compared to net cash used in operating and investing activities of $8 million for the three months ended December 31st, 2023. I also wanted to note that early in the first quarter, the company raised approximately $600,000 through its ATM program at an average price of $27.12 per share. Now turning to guidance. For the full year of 2024, we now expect total revenue between $50 million and $53 million. We now expect full-year gross margin between 83% and 85%, and we now expect operating expenses between $92 million and $98 million. For the second quarter of 2024, we expect to report total revenue between $11.3 million and $12.3 million. I would now like to turn the call back over to Kevin.
spk03: Thanks, Jared. I'm thrilled to be part of this company with our world-class team and our barostim therapy that is making a profound difference in the lives of patients with heart failure, a massive market opportunity with few effective device therapies. After three years of commercialization, we're taking a thoughtful look at the current state of the therapy's adoption and the opportunities we have to accelerate our market penetration. Our ultimate goal is to establish barostim for HFREF as the standard of care. Key areas of near-term focus include broadening awareness of our therapy, bolstering clinical evidence, and strengthening our patient access efforts. To this end, we are actively seeking to build out our leadership in the medical affairs, clinical, reimbursement, and sales areas. These leaders will help us to better align our commercial and R&D resources to drive long-term adoption of barostim in the HFREF market and additional indications. I look forward to sharing more specifics on these initiatives in future calls. As a result of the sales turnover and initial changes to our go-to-market strategy, which will take time to implement, we have elected to lower our annual guidance. Despite this short-term disruption in the business, we remain very excited about the significant potential for BarroStim to transform the treatment paradigm for the millions suffering from heart failure and other cardiovascular diseases. and our ability to drive our therapy towards standard of care. And now, I'd like to open the line for questions. Operator?
spk10: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star and then one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star and then 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 keys. The first question we have is from Robbie Marcus of JP Morgan. Please go ahead.
spk00: Hi. This is actually Lily. I'm for Robbie. Thanks for taking the question. Two for me. Maybe I'll ask them both up front. I guess can you talk through a little bit more what exactly happened in the quarter to drive the softness? It seems like demand and execution has been really strong otherwise. You have the expanded label. So how exactly did the change up top disrupt what's happening on the ground with the sales force? And then part two, you lowered the guide by more than the amount that you missed by. So how much of that is conservatism versus actual softness in the business and what you expect to see over the rest of the year? Thank you.
spk02: Thank you, Lily, for the question.
spk03: This is Kevin Hykes. Let me give you a little bit of color on what we observed operationally in the quarter, and then I'll have Jared discuss the impact on the metrics. In the quarter, we saw higher than anticipated Salesforce turnover, which led to a disruption in our selling efforts. There's a few reasons I think that this occurred. The first, Nadim's departure as CEO after 17 years may have been a trigger for a number of reps who were perhaps already on the fence about departing the company. Secondly, the sales cop plan for 2024 that was rolled out just before I joined the company in February was not in line with what the sales team was expecting, which contributed further to the disruption. Lastly, these first two issues were exacerbated by the time of year, as the first quarter is often when reps seek to change roles. So in response to these factors, we quickly took action to try to solidify the sales team. We made significant changes to the comp plan, which were well received and allowed us to get the team refocused in the last month of the quarter, which was positively received. Also, as we announced today, we're making changes in the sales leadership as well. And I believe that these actions have stabilized the team and should allow us to regain our momentum into Q2.
spk05: David McGoldrick, Lillie I'll jump in on the guidance question so first to just kind of close out the first point from Kevin so. David McGoldrick, You know, impacting Q1 we believe the biggest factor was that salesforce disruption that Kevin mentioned that we saw early in the first quarter. David McGoldrick, It really manifested itself in a few ways we added fewer territories than expected, it led up led to us opening fewer active implanting centers than we had anticipated. And the centers that were open were actually less productive than expected as new reps were ramping up and getting introduced to those existing territories that they were taking over. When we think about the guidance for Q2 and the rest of 2024, I think part of this is it's a shift, right? So in Q1, we were not able to add as many new territories or active implanting centers. as we had anticipated and that means we'll have a lower base from which to generate revenue for the remainder of the year. It essentially shifts our future quarterly revenue expectations back by a quarter or about a quarter which has the impact of lowering the midpoint of our annual revenue guidance by about three and a half million dollars. Obviously our focus for the rest of the year is going to be to work to train our newer sales reps to build and build more in-depth programs at each of the active implanting centers.
spk02: Yeah, I think that puts a point on it. Great. That's helpful. Thank you. Thank you.
spk10: The next question we have is from Matthew O'Brien of Piper Sandler. Please go ahead.
spk07: Hey, this is Phil on for Matt. Thanks for taking our questions, and Kevin, congrats on the new role. Just for starters, you know, looking at Q2 implied guidance of mid-20s growth, when I plugged it in my model, I'm getting a fairly aggressive reacceleration in the back half of the year. What does guidance assume as far as the disruption leaking into that back half, if at all, and what gives you that confidence in that steep ramp for the second half?
spk05: Yeah, hi, Phil. This is Jared. I can take that one. So, you know, when we put the model together for the rest of the year, we did take into consideration that we had some newer reps backfilling the existing territories in Q1, and we were only able to add one additional new territory. We did really successfully bring on a bunch of new reps at the beginning of the year. We're really happy with the level of talent that we've been able to attract. That's going to allow us to continue to add more territories throughout the rest of the year, hopefully getting us back on track to adding about three per quarter. As far as, you know, the risks or uncertainties of what could happen in the back half of the year, it really just comes down to our ability to get these reps trained up, introduced to the existing active implanting centers. and get them really out there working to activate some of these new active implanting centers. But we're feeling pretty confident in our ability to do that based on the history that we've been able to show.
spk07: That's helpful. Thank you. And just a quick follow-up on OpEx, specifically on the SG&A side of things. Even accounting for the stock option adjustment, it looks like SG&A increased fairly meaningfully as a percent of sales. And, you know, given you're onboarding several new roles, You know, where to expect this number and the spend here to go in the long term?
spk05: Yeah, it's a good question. You know, it was a pretty big jump from Q4. I just want to call out that, you know, roughly $8.4 million of that was tied to that one-time non-cash stock-based compensation expense tied to Nadeem's stock option modification. Again, that's not for new equity that was granted. It's just driven by accounting rules for us to recognize those costs associated with the options that were modified. It is non-cash. It is non-recurring. I'd also like to point out that going from Q4 to Q1 in the past, we have seen an increase in SG&A that then starts to level out. Part of that is driven by our process for doing annual reviews and giving raises to employees, but it's also tied to our annual sales meeting where we bring our entire sales and marketing organization together to talk about the new programs and new data that we can go out and start marketing for our physicians. And then the final part is the head count. Obviously not tied to sales, but most of the rest of the organization will add new heads early in the year, and then we start to see those overall numbers start to flatline.
spk02: That's helpful. Thank you. Thank you.
spk10: The next question is from Margaret Cazor of William Blake. Please go ahead.
spk01: Hey, good afternoon, guys. Thanks for taking the question. I guess just to put bluntly and make sure that we're all aligned, are you continuing to see disruption in the sales force or do you think you've stabilized at this point? And then, you know, the existing reps that you guys do have, maybe you can kind of give us some metrics to help support how they've been doing, right? So if we take out the excess turnover that you had. Can you give us anything around utilization growth, productivity metrics for those reps that kind of were left, I guess?
spk03: Sure. Thanks, Margaret. I appreciate the question. I guess the short answer is yes. We believe we have stabilized the team following a bumpy February for the reasons I described before. We're seeing a solid performance in March and we're pleased with what we've seen going forward. So we think we have, in fact, addressed those issues.
spk05: Yeah, and Margaret, on the metrics, I'm not going to dive into the weeds for, you know, rep by rep productivity, but overall, we did see a solid rebound in the month of March across all of our territories. Part of this lower productivity for the entire quarter is still driven by a slower than expected February. But we did see a lot of that productivity come back in the month of March, allowing us to feel confident in putting together this guidance for Q2 and the rest of the year to show continued growth.
spk01: Okay. And you're not going to talk about April trends, or has that continued, I guess, through April?
spk05: Yeah, good question, Margaret. Yeah, we're not going to get into the details on April at this point in time, but you can see from the guidance we put out for Q2 that we are expecting to return to pretty solid growth on the U.S. heart failure business.
spk01: Okay. And then, you know, I wanted to focus a little bit on 24, and you're going to love me because I'm going to ask the 2025 question as well. But, you know, what's assumed in guidance for ASP? Is it a higher ASP similar to what we saw this quarter? Again, utilization trends, you know, reps at year end, you know, new accountants per quarter, just trying to get a sense of, again, kind of that conservatism versus the more aggressive assumptions. And then we push this into 2025, right? The question ultimately is, you know, is that the year where we get back to those productivity and utilization levels that were assumed for this year? Or is it just going to be kind of a slow and steady progress, so trying to pinpoint that exact moment is maybe too hard today?
spk05: Good question, Margaret. I'll see if I can knock all of them out here. So, as far as what we're assuming in the guidance for 2024, we think of what the disruption that had occurred in Q1 as kind of shifting our expectations back a quarter. So, maybe what was expected in Q1 is now kind of coming towards Q2. To dive into the weeds a little bit on ASPs, we were able to see higher than expected ASPs in 2024. They are at levels in the U.S. hard failure business that we saw back in 2023. So, you know, we haven't necessarily seen a drop in that number as we move from one year to the next. The second piece is, you know, number of territories. We were only able to add one in the first quarter versus expectations of trying to add three as we have since every quarter since the IPO. We believe with the strong bench and the pipeline that we have built for the sales rep or within the sales organization that we can get back to adding at least three territories per quarter as we march through the rest of this year. The number of AICs, I'm not going to give specific guidance as to what the expectation is there for the rest of the year. One key thing for us is as you bring on new active implanting centers, it can be a little choppy as far as when they actually come on board. We still feel like we have a really strong pipeline of customers that have signed contracts and gone through the value assessment committee. But it depends on patient selection. You know, if they pick a patient that requires a prior authorization because they're a Medicare Advantage patient or because they, you know, are covered by a private payer, it's going to take a little longer because going through prior authorizations just takes time, right? So at this point, we're not going to give specific guidance for how many AICs we expect to add, but we do feel like we have a really strong pipeline of customers with signed contracts at this point in time. As we think about 2025, I think a lot of the focus that Kevin is bringing towards the commercial organization is going to really help the sales reps not only be able to become more productive themselves and where they focus and where they spend their time, but also give them more tools to be able to go out and have more conversations with these physicians. And I'll just add to that, give our DTC folks a lot more information to share with prospective patients in that process. So we're feeling pretty bullish about how 2025 could shape up.
spk01: Okay. And I'll sneak one more in. I apologize to all my other colleagues on the line. But, you know, Kevin, you mentioned a lot of new priorities hiring. It seems like you're trying to hit the ground running relatively quickly here. you know, how quickly would you expect to see some of these changes not only take effect, but really have a meaningful impact on demand? So, you know, what kind of clinical evidence are you referencing? What examples are you looking for? And kind of the same on the coding coverage and payment side. Thanks.
spk03: Sure. Thanks, Margaret. So, yeah, I'll break that perhaps into two sections. So, as it relates to the new executives and the new skill sets that we're bringing into the company, I'm pleased to reported, this is even in the last few days, that we have actually hired the Senior Vice President of Global Clinical Affairs. We'll start May 1st, actually this week. Over the last 48 hours, I have successfully hired a very senior Senior Vice President of Patient Access, Reimbursement, and Healthcare Economics, who we will expect to start by the end of May. And I'm in the last innings on the recruitment of a very qualified Chief Medical Officer candidate. So in terms of those executives joining the team, I think that will be within the next month to two months at the outside. And I think in many cases, their impact will be felt immediately. Those are areas of great need, and their expertise is significant, and I think we'll really benefit from that. As it relates to the increased focus on sort of these three barriers to adoption, you know, that being the awareness of our therapy and its appropriate role in the treatment of heart failure, number two, the evidence we can generate, and number three, the degree to which we can accelerate or facilitate access, that will take longer, but I believe we'll start to see the impact of some of those efforts as early as next quarter or certainly by the back half of this year. And as we described in the earlier comments, that's part of a very deliberate approach to market development and part of an understanding of exactly what barriers we need to address in order to move this therapy from 2% penetration towards standard of care. So, again, in each of those buckets, there are different strategies that we'll employ and investments that we'll make. You asked about the clinical evidence piece, and I think an important shift here is perhaps away from or balancing what has been a historic focus in a significant indication expansion effort with a much more rigorous prosecution of our existing indication and trying to draw data from multiple sources, including our long-term data set, but also any one of the four registries that we're running, physician-initiated research, real-world evidence, really trying to understand how we mine those data sets to create a much more intentional cadence of evidence and support for our existing therapy. And, you know, the first of those were presented at THT. There'll be more presented almost each quarter going forward. That's our intention. And so our hope is that that will provide our sales team on the ground, our DTC team, with the ammunition they need to raise awareness and appropriately educate physicians and patients alike on the role of this therapy in the treatment of heart failure. I'll stop there.
spk02: I hope we addressed your question. That was great. Thank you, guys.
spk10: The next question we have is from Bill Plovenick of Canaccord. Please go ahead.
spk09: Great. Thanks for taking my question. Just curious, as you look at your account base, as you mentioned, it went up a little in terms of active accounts. I think, Jared, you mentioned it would be a little choppy. With the turnover of the sales force, have you seen – first of all, I don't know if you quantified what percentage of the sales force has turned over. how many regional managers or just local reps, if you could quantify that if you haven't. And then second is on the accounts, you know, if you lose the rep, do you lose the account and they stop doing it because they need somebody there to hold their hand? Just help us understand what this has done to your existing set of accounts. You know, and maybe that's why you have the confidence going forward.
spk05: Yeah, good question, Bill. So when we saw the disruption in the first quarter, saw some turnover, I want to emphasize that this is not at the leadership level within the sales organization. This is more at the sales rep level. the ones that are out there every day talking to physicians, talking to the hospital administrators, we do see a bit of a pause, right? As you go through a transition and hand over those active implanting centers from one rep over to another rep, it does take time to rebuild those relationships, kind of work to connect the dots to make sure that this market development effort can continue. And I just want to emphasize that piece, right, the market development portion of this, It's not us going in with a better mousetrap, swapping out for a better device. This is us going out, educating these physicians, working with the nurses to help so that they can identify the right patients for this therapy. And so as we make transitions from one team member to another, it just takes some time to get back into the swing of things for those active centers. And I think As we saw in March, a lot of those handoffs had taken place. We were able to see productivity pick back up, giving us confidence that we can continue to grow this business and see increased productivity over time.
spk09: Okay, thanks. And then just what's your thoughts on the atrial shunting market, the competitive? Is that competitive to you? Is it additive? I think, you know, something that people were paying a lot of attention to, and obviously some of the recent studies have been disappointing. But I was wondering what type of effect that may have had or may have on your business. And thanks for taking my questions.
spk03: Sure. Thanks, Bill. I'll take that one. You know, we watched, like many of you probably with great interest a couple of Saturdays ago at ACC. at the RelieveHF trial result release. And, you know, it was, I think, somewhat paradoxical. I've spoken to a lot of physicians about that. But, you know, intriguingly, the population that was expected to benefit actually did not. And the one that was not expected to benefit as much, in fact, did. And in both cases, the placebo patients, the control patients did as well or slightly better. So lots of very sort of, I guess, straight or paradoxical sort of results from that trial. I think the only thing we have discerned from lots of conversations with physicians is that there's a lot more work to be done. Those results I quoted, as you probably know, are not powered. And there's some hypothesis generation here, perhaps, but significantly more work to be done on sort of the appropriate population for intraatrial shunts and the appropriate role in the treatment of heart failure. I think a number of physicians have suggested, even as recently as this week, that on some level, shunts are creating a pathophysiology to address a pathophysiology. And so I think there's some mechanistic questions still about how they might work and how they best fit into the treatment paradigm. But in the short term, we're not hearing much about them. It has had no effect on our work in the market at all.
spk02: But we're watching it with interest. Thank you.
spk10: The next question we have is from Frank Tekenen of Lake Street Capital Market. Please go ahead.
spk06: All right. Thanks for taking the questions. I just want to follow up on one point, and I apologize if you said it already. I was jumping between a couple of calls. Commercial disruption, did you guys talk about the exact net number, the turnover in reps, and then the number of reps that you've hired back since that turnover has occurred?
spk02: Sure. Thanks, Frank.
spk03: We did not give specifics on that number. We would prefer not to. As Jared said, we normally seek to open three new territories each quarter, and in this last quarter, we opened only one new net territory. So, obviously, significantly fewer than we had hoped, largely because we were replacing backfilling territories with some of the newer reps as a result of the turnover instead of opening brand new territories. So, I think we'll hold on further detail there. But again, we're confident that we have seen the stabilization of that dynamic and that with strong hiring in Q1, we're able to rebuild the momentum that we lost in February briefly.
spk06: Okay, that's helpful. And then maybe just turning over to the label expansion late from last year. I know we're only a quarter into it, or I guess a quarter plus a month, but maybe talk about any anecdotal feedback you're hearing in the market, any plan changes related to some of the marketing initiatives you may put forth, just any update related to how that label change has impacted the market dynamics.
spk03: Sure, thank you. I'll take that one as well. So I think, you know, we've been quite pleased at the response, both to the label expansion and the publication of the BEAT-HF data in the last couple weeks. It was published, as you know, in the European Journal of Heart Failure and showed the sustained symptomatic improvement over 24 months, a 34% reduction in the likelihood of death or need for an LVAS transplant, and continued very favorable sort of long-term safety profile. So overall, both as it relates to the labeling and the durability of our therapy. There's been a lot of positive response. Now, I should point out a couple of instances where we are now mining that data set for additional. I spoke of this sort of cadence of evidence that we're trying to build, post-market evidence. We presented two brand-new abstracts at the THT conference in March, one of which showed a 74% reduced risk of advanced heart failure interventions with barostim therapy over those 24 months. And those advanced interventions would include transplant, LVAD, CCM, CRT, cardiomems, et cetera. So really sort of compelling data that was within that data set. Secondarily, some additional interesting work on the quality of life scores over time for patients that received this therapy. We're pleased at the response. We're continuing to push that data set and the expanse of the labeling out through our sales team and from the podium as well at the various conferences as well as through our DTC channels. So it's still early, but there's a rich data source there that we intend to mine for quite some time to come to build that cadence of evidence.
spk02: Perfect. That's helpful. I'll stop there. Thanks for taking the questions. Our final question is from Chase Knickerbocker of Craig Hellam.
spk10: Please go ahead.
spk08: Good afternoon, guys. Thanks for the time, and good to have you on board, Kevin. Just want to dig in a little bit more on existing customer utilization. So it's actually down sequentially, you know, despite a better label and, you know, much better reimbursement. Should I think of the entirety of The only reason that it is down sequentially was because of the sales rep turnover. And then on the other side of that, just maybe speak to those sales reps in those territories that were stable and, you know, did have the same, you know, person in that seat. Maybe speak to what utilization trends looked like there because did they see a benefit from that better reimbursement effective January 1st?
spk05: Yeah, hi, Chase. I can handle that one. I just want to make sure we're all on the same page from some of those updates we saw towards the end of 2023. So the first one is on the reimbursement front. So as everybody remembers, we moved from being mapped to one APC plus having an add-on payment that gave total reimbursement to hospitals on average of about $45,000 in 2023 when they would do a barostim procedure. to in 2024 being mapped to a new tech APC without an add-on payment. And in that case, the hospital still receives on average about $45,000 for the procedure. So the change from 23 to 24 was technically net neutral, but the positive note moving into 24 was we didn't lose the difference of an add-on payment. Right? So overall, you know, the change was net neutral from a reimbursement perspective. The data for those currently active implanting centers, a lot of them had seen it, right? They had an interest in BarroStim. They knew the long-term data, the post-market data was going to be coming out at THT in 2023. So a lot of them were aware of this long-term data. And so the FDA approval in December maybe didn't affect a lot of those centers as much because a lot of them were well-educated and stayed up to speed as we released that data back at THD. The benefit for us now is we can actually go out and proactively promote this data to those newer centers or those newer referring physicians that have not seen BarroStim or seen this long-term data because they didn't have an interest. the year prior at THT. So I think that's where we'll see some benefits, but activating those new centers, utilizing that new data is just going to take some time in 2024 and then to get them ramped up and starting to treat patients. As far as the territories that had stability, yeah, we definitely saw a difference, right, for those folks that were here and stayed on staff and what they were able to do as far as productivity within their territories versus those that had turned over.
spk08: And is that true kind of relative to Q4 as well and then kind of talking about that past repayment no longer being required? Is it not the right way for us to think about that as it is kind of a catalyst to adoption just because they don't have to deal with that, you know, separate payment path through? Or are we thinking about that incorrectly?
spk05: Yeah, so going from Q4 to Q1, again, overall utilization rates were down, right? But we did see some of those active territories see the overall utilization increase. As far as the reimbursement goes, that is a good point. So the transitional pass through or that add on payment for the outpatient procedures is a complicated calculation. Nadim and I would previously talk about how it was a bit of a barrier because many of the hospital administrators were not aware of that transitional pass-through or they didn't see it very often. And so they would often want to test out a few patients, see what reimbursement would come back at before they would start treating more and more patients. So the hope is that as we move forward with just having one code that the hospitals need to utilize, that it removes one of those barriers for the hospital administrators to put a hold on these types of procedures.
spk08: Got it. And then maybe just quickly on BATWIRE, have we kind of adjusted our thinking on, you know, thinking that if we can kind of keep this with EPs that it would benefit adoption ramp? Or just kind of walk me through some of the thinking there.
spk05: Yeah, I can take that one as well, Chase. So, going back to 2020, when we were initially kicking off this clinical trial, we were very early in our commercialization stage. One of the hypotheses that we had was that we would have to get an electrophysiologist involved in the program to see this program be able to be built out more fully. As we've continued to develop new centers and bring on new surgeons, the referral pathway is not as complicated as we had once thought. seeing the general cardiologists work with the vascular surgeons, it's worked quite well. And in many of the centers where we had both a commercial program available and the BATWIRE tool available, many of the patients were actually electing to go the commercial path rather than be part of a clinical trial. So I think, you know, the old hypothesis that we needed an electrophysiologist to be involved to see this ramp is maybe less important to us. That being said, we do utilize or work with some electrophysiologist champions at specific centers and are very happy to work with them as they're identifying patients that could be treated with barostem as well.
spk02: Got it. Thanks, guys.
spk10: That concludes the Q&A session, and I would like to turn the floor back over to Kevin Hikes for closing remarks.
spk03: Thank you, Operator. Thanks again to everyone for joining us for our first quarter earnings call. We appreciate your ongoing support, and we look forward to updating you on our progress on our next update.
spk02: Thank you. This concludes today's conference. Thank you for joining us. You may now disconnect your lines.
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