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spk04: Greetings and welcome to the CVRX Q2 2023 earnings call. At this time, all participants are in a listen-only mode. A brief 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 your host, Mike Valli. Thank you, Mike. You may begin.
spk06: Good afternoon. Thank you for joining us today for CBRX's second quarter 2023 earnings conference call. Joining me on today's call are the company's president and chief executive officer, Nadeem Yared, and chief financial officer, Jared Oshine. 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-Q 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.
spk07: Thank you, Mike, and thanks to everyone for joining us. I'll begin today's call by providing an overview of our second quarter performance, followed by an operational update and a review of our financial results by our CFO, Jared Oshime. Then I will conclude with our thoughts for the rest of the year before turning to Q&A. We are thrilled to share that we had another excellent quarter. The nearly 120% year-over-year growth that we delivered in the U.S. exceeded our expectations and is highlighted by the strength in volumes, the expansion of the new U.S. active implanting centers, and the development of our new customer pipeline. Importantly, we are continuing to receive very positive feedback from physicians regarding their own experience when using our barostem therapy on their patients. Our financial performance continues to demonstrate the quality of the BetterStim procedure, the robust demand for BetterStim in the market, and our ability to execute. Now, let's dive into the details of our performance during the quarter. Worldwide revenue was $9.5 million, an 89% increase over the second quarter of 2022. This was primarily due to the continued execution within our U.S. heart failure business, which grew by 119% over the prior year. These results came from the ongoing utilization of BarroStem within our existing customer base, our successful expansion into new territories, and the elevated physician and patient awareness. We are encouraged that following our February announcement of the preliminary results of the BEAT-HF trial, adoption and utilization of Peristem has continued to grow. In each of the four months following that announcement, the business has been strong and physicians have seen the data at scientific meetings have had positive reactions. turning to an update on our operational progress during the second quarter. As a reminder, our focus areas are the continued expansion of our commercial infrastructure and the expansion of our clinical body of evidence. starting with a continued expansion of our commercial infrastructure. As expected, we added three new U.S. sales territories, bringing the total to 32. The talent we have been able to attract and put into the field is impressive, and we look forward to continuing to leverage their abilities to educate and train physicians and healthcare providers on Barrister. Also, during the second quarter, we further progressed our marketing initiatives, including our direct-to-consumer and patient education programs, which we will continue to optimize to support our commercial strategy. Moving to our second focus area, the expansion of our clinical body of evidence. As announced in June, we submitted a PMA supplement to FDA, which included data collected as part of the post-market BEAT-HF study. As a reminder, the PMA supplement is seeking a potential label expansion for barostim in line with the recommendation of the Executive Steering Committee of the BEAT-HF trial. We fully agree with the committee's assessment that the totality of evidence strongly supports barostim as a safe and effective treatment option for heart failure. We are currently undergoing the normal review process with FDA and expect to receive a response from FDA by the end of the year. We remain committed to closely monitoring the progress and will provide updates when we have significant developments to share. One last update. CMS recently released the proposed outpatient prospective payment system, or OPPS for short, for 2024, along with a proposed physician fee schedule for the same period. Of particular note was the absence of any mention of our March submission requesting assignment to one of the new technology APC payment codes as our transitional pass-through additional payment expires at the end of 2023. We anticipate submitting formal comments on the proposed OPPS package and advocate for inclusion in the final document later this year. However, Please remember that our base case for 2024 is the status quo, which would lead to a reduction in our expected average selling price across the US to approximately $26,000. This has been the assumption in our model that is guiding us to be able to reach cash flow breakeven without the need to complete an equity financing. We are very excited about what we have been able to accomplish during the second quarter and throughout the first half of 2023. Through the first six months of the year, we have grown our U.S. heart failure revenue by 124% as compared to 2022. We look forward to continuing to build on this momentum for the balance of the year, and I want to thank our team for their dedication to our mission of improving the lives of patients suffering from heart failure. I'll now turn the call over to Jared to review our financials. Jared?
spk08: Thanks, Nadeem. In the second quarter, total revenue generated was $9.5 million, representing an increase of $4.5 million, or 89%, compared to the same period last year. Revenue generated in the U.S. was $8.3 million in the current quarter, reflecting growth of 111% over the same period last year. Heart failure revenue in the U.S. totaled $8.3 million in the current quarter, on a total of 265 revenue units. compared to $3.8 million in the second quarter of last year on 128 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 BarroStim. At the end of the current quarter, we had a total of 140 active implanting centers, compared to 71 on June 30, 2022, and 122 on March 31, 2023. We also had 32 sales territories in the U.S. at the end of the current quarter, compared to 20 on June 30, 2022, and 29 on March 31, 2023. Revenue generated in Europe was $1.2 million in the current quarter, representing an increase of 10% compared to the same period last year. Total revenue units in Europe increased from 52 in Q2 of 2022 to 56 in the current quarter. The number of sales territories in Europe remained consistent at 6 for the three months ended June 30, 2023. Gross profit for the three months ended June 30, 2023 was $8.0 million, an increase of $4.2 million compared to the three months ended June 30, 2022. Gross margin for the current quarter increased to 84% compared to 76% for the same period last year. Gross margin for the three months ended June 30, 2023 improved primarily due to a decrease in the cost per unit driven by increased production volumes. Research and development expenses for the current quarter were $3.3 million, reflecting an increase of 39% compared to the same period last year. This change was driven by a $0.6 million increase in compensation expenses as a result of increased headcount, a $0.1 million increase in non-cash stock-based compensation expense, and a $0.1 million increase in consulting fees. SG&A expenses for the current quarter were $16.5 million, representing an increase of 32% compared to the same period last year. This change was primarily driven by a $2.5 million increase in compensation expenses, mainly as a result of increased headcount, a $0.8 million increase in marketing and advertising expenses associated with the commercialization of Barro Stem in the U.S., a $0.4 million increase in travel expenses, and a $0.3 million increase in non-cash stock-based compensation expense. Interest expense increased $0.5 million for the three months ended June 30, 2023 compared to the three months ended June 30, 2022. This increase was driven by the interest expense on the borrowings under the loan agreement entered into on October 31, 2022. Other income net was $0.6 million in the current quarter compared to other expense net of $34,000 for the same period last year. The income in the second quarter of 2023 was primarily driven by interest income on our interest bearing accounts. Net loss for the current quarter was $11.7 million or 56 cents per share compared to a net loss of $11.1 million or 54 cents per share for the same period last year. Net loss per share was based on 20.7 million weighted average shares outstanding for the second quarter of 2023 and 20.5 million weighted average shares outstanding for the second quarter of 2022. At the end of the second quarter, cash and cash equivalents were $90.8 million. Net cash used in operating and investing activities was $12.95 million for the second quarter, which included our annual premium for our directors and officers insurance of approximately $2 million. This is compared to net cash used in operating and investing activities of $10.5 million for the three months ended March 31, 2023. Now turning to guidance. For the full year of 2023, we now expect total revenue between $37.0 and $38.5 million, up from $35.5 to $38 million. We now expect full-year gross margins between 83% and 84%. up from 80% to 83%. And we now expect operating expenses between $78 and $80 million, up from $76 to $80 million. For the third quarter of 2023, we expect to report total revenue between $9.5 million and $10.2 million. I would now like to turn the call back over to Nadeem. Thanks, Jared.
spk07: We had a fantastic first half of 2023. Our strategy for driving the adoption of Meristem while continuing to deliver improving financial performance is working, which has resulted in increased revenue guidance for the second consecutive quarter. We are particularly pleased that the business has continued to flourish, particularly since the announcement of our BEAT-HF data in February, and we remain optimistic about our plans to continue to grow. We look forward to building on our success during the back half of this year. And now, I would like to open the line for questions. Operator?
spk04: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 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. One moment, please, while we poll for questions. Thank you. Our first question comes from Robbie Marcus with JP Morgan. Please proceed with your question.
spk03: Hi, this is Alan on for Robbie. Congrats on the good quarter. You know, just starting with, you know, some of the momentum that you saw, you know, through first quarter and second quarter, we really saw that translating into better, you know, active and planting centers than I think originally contemplated. So what are you seeing in the third quarter so far when it relates to that? And, you know, how sustainable do you think that level of, you know, more mid to high teen center ads will be into third quarter, fourth quarter, and then beyond that?
spk08: Hi Alan, this is Jared. I can take that one. Thanks for the question. So we've seen really strong numbers for active implanting center additions over the last few quarters. You know, we talked about this back in 2022 as COVID moved to the wayside and hospital staffing shortages were kind of solved. We started to see more interest from hospitals to get these programs off the ground and that's allowed us to activate these centers. We remind everybody that the contracting process does take time and therefore we do have some insight into the pipeline of new centers that are on contract through value assessment and champions identified. And then the next step in the process to be identified as an active implanting center is to get that first patient treated. And that's where, you know, some of the hospital, you know, staffing shortage issues could come into play in the future. But I think as we look forward into Q3 and Q4 and out into 2024, we're still expecting to see about 12 to 13 new active implanting centers per quarter, just based on the volume and the current pipeline that we're seeing today. So because of the beat in the second quarter, it doesn't necessarily mean that we're going to see a slowdown in the new center ads in Q3 and Q4.
spk03: Got it. That's good to hear. And then, you know, when I look at the guidance, you know, for 9.5 to 10.2, kind of an implied 10.0 to 10.8 million in fourth quarter. It seems like, you know, pretty measured improvement given the increases we've seen, you know, so far this year. So why is that the, you know, the appropriate level of increase we should forecast going forward? You know, I think the general sense of that staffing, those kinds of dynamics have gotten better so far this year. So why shouldn't we see room for more upside in the back half? Thank you.
spk08: Yeah, I'm happy to take that one again, Alan. Yeah, I mean, we're really happy with the results that we've seen to date. You know, I think as we look to provide guidance for Q3, we take into consideration what the current funnel is looking like, what the new active implanting center implant rates are starting to look like, and then also what's on the horizon. And the other thing that we take into consideration is the results we've seen so far in the quarter and what we've seen in July. I think as we march ahead into Q3, historically coming out of COVID, we have seen slowdowns in the month of August, right, where people take long vacations. Now, there's been no signals of that for us yet. And we did just see our biggest jump ever from one quarter to the next from Q1 to Q2, just in a pure dollar amount of revenue. And so we didn't want to get ahead of ourselves with increasing the guidance too much and feel pretty comfortable with that range we gave of 9.5 to 10.2 for Q3.
spk04: Thank you. Our next question comes from Matthew O'Brien with Piper Sandler. Please proceed with your question.
spk02: Great. Thanks for taking that question. So, Nadim, this one's for you. You've got a lot of experience on the reimbursement side of things. And, you know, just help us get a sense for your – the potential for you to get – this APC code here in the final rule, because if you don't, the 26,000 ASP is the first time I've heard that number specifically. Maybe I missed it, but, you know, based on what you're going to do this year from an ASP perspective, that's a pretty meaningful, like 15% headwind just on the pricing side as we go into next year. So, you know, that's, obviously you're still going to be able to grow nicely on the unit side, but you're going to have to deal with that headwind potentially on the ASP side of things. So just help us think about that dynamic you know, and the impact on the business, both on the top line and even gross profit line, because gross profits are great, but, you know, ASPs are down 15%. That's going to be impactful to gross margins. So just help us think about the potential to get that extra code or get the code that you're looking for and then the impact to the business if that doesn't happen.
spk07: Sure, Matt. Thanks for the question, by the way. I would ask Jared to answer the second half of the question. Let me answer the first one about the CMS and how to, think about the process. We don't have much experience in this, but we looked at what happened exactly last year with a similar process followed by another small company that's now part of Zoll. I'm mentioning GrespiCardio. They followed the same process. Their application was not mentioned in the summer's proposed ops. Then they went in front of a panel made the case for it. We supported them as well as other constituencies, and they got it at the end of the year. What does it tell us? Well, not much, because every case is different. No matter how much we can find similarities and try to find solace in here that, you know, it worked for them, why wouldn't it work for us? That's not how CMS necessarily will be looking at things, and we don't understand what are the parameters that they will utilize in here to define whether they take a request like ours into account or not. That's why we have been modeling internally that the ASP will be lowered in the future. Actually, let me turn here to Jared to walk you through a little bit about how we're thinking about it from a gross margin and ASP.
spk08: Yeah, Matt, I mean, this has been on the horizon for several years now, right? We knew the expiration of this add-on payment was going to be December 31st, 2023. So we tend to take the conservative route when building these longer-term models. And so we wanted to take that into consideration to what our average selling price would be in 24 and beyond. And so as we look out to 24 with our base case, assuming we are in the same APC that we are today, that average selling price would be between $25,000 and $26,000. Now, it doesn't drop off a cliff overnight. That number probably comes down over time. But I think the nice thing that we've shown here in 2023 with volume, we can see that cost per unit drop pretty dramatically. That's allowed us to achieve gross margins of 84% in the current quarter. And even with a decrease in the revenue or in the average selling price in 2024, we still believe growth margins of 80% in the short term would be attainable just based on volume and seeing that cost per unit drop.
spk02: Got it. Okay. I appreciate that. And then, you know, BDHF came out recently. I'm just curious, did you see any pause from, you know, some of your centers as they were digesting that information? Anybody that said, I don't like that or where it's potentially negatively impactful to the business? I know you still did well in Q2, but did you see any of that? And then just help us think about, you know, if you're able to get this indication for the treatment of HF, I know it helps validate the technology some more, but what does that do from a selling perspective? Is it going to make it easier for new centers or just to go deeper in existing centers? Thanks.
spk07: Yeah, excellent question. So let's start first with one reminder to everybody. Where we are right now where the manuscript is not yet published and FDA has not given us the authorization to make any claims based on the data, we as a company are not allowed to proactively share with healthcare providers or patients the results of PTHF. We can only answer questions when these questions are asked. So whatever impact we have seen so far has been limited to the physicians or other healthcare providers who have seen the BTHF data presented at a scientific meeting by another healthcare provider, period. What's the percent of sites that have seen the data and comment on it? I don't have that split exactly. Nevertheless, we have not, I can repeat this over and over, we have not seen any slowdown, even at the height of the uncertainty between February 21st and March 21st, when we went out publicly and we mentioned that we did not meet the primary endpoint of the trial without sharing the data until a month later when the data were presented at the late breaker at DHT. During that month of uncertainty, even then, we had not seen or observed any slowdown of activities in the site. That also kind of, you know, moved us into providing some level of directionality of revenue on a monthly basis in Q2 to alleviate any of this concern and give confidence in here that we are still on the right track. Now, can I say for sure that those that have seen the results are, you know, implanting more patients, treating more patients or not, that's hard to quantify and hard to link our current growth with the results per se of PTHF. To your second part of the question, what do we expect if we get the labeling? Well, the total addressable market should increase a little bit based on the expansion of labeling. If you recall, when we did this, and it's disclosed actually in full details in our S1 and subsequent filing, when you go through the funnel, at the last step in the funnel, we eliminated from the total addressable market many patients who have other comorbid diseases, assuming that when a therapy is assumed to be only treating symptoms, it may not be prescribed to a patient who have other comorbidities. So we went a little bit conservative on our assessment of the total addressable market. Now, if we get the treatment labeling from FDA, we believe that some of this market will be addressable. Therefore, the total addressable market will increase. We're not at the point yet to disclose what the new number will be of new patient's new patients eligible for our therapy on a yearly basis yet. But at the right time, once we have clarity from FDA, what is the label that they're allowing us, then we will do this exercise and we'll come back to everybody with it. So will we see an increase? Will we see an impact? Possibly, but that will be next year. Will it be sufficient to alleviate your previous concern about the drop in ASP? I believe so, but we're not there yet. We're not yet at the point where we're giving guidance for 2024. Got it.
spk02: Understood.
spk10: Thanks so much. Thank you, Mike.
spk04: Thank you. Our next question comes from Margaret Cashmore with William Blair.
spk01: Please proceed with your question. Hey, good afternoon, guys. Thanks for taking the question. I wanted to see if you guys would provide any additional details in terms of cases throughout the summer months and maybe into July and how that might compare to traditional summer seasonality.
spk08: Yeah. Hey, Margaret. This is Jared. So, I know we've discussed month-to-month results here over the last few months. You know, after we came out with the Q1 results, we talked about how momentum was continuing into April. We also gave the update, I know, at your conference about how May was continuing to be pretty strong just from a procedural perspective. But now that we've gotten through this, you know, process of disclosing the clinical data around BDHF, where there was maybe some uncertainty from investors out there about what was going to happen with the business, we're trying to get back into the traditional approach of, you know, sharing results on a quarterly basis and then giving that guidance for one quarter forward. So this is not in any way to indicate that we have concerns about what we're seeing in July, right? This is just us getting back to the normal cadence of, you know, deliver a quarter, give the guidance, and move forward there. So I think we're going to pass on the question today to give any updates on July.
spk01: Now understood. So I'll take a second crack at a slightly different question, but I'm just curious, as you look at the utilization growth that we've seen, you've now got some more tenured accounts. You've got some newer accounts online. Any surprises there? Or can you talk about a profile of account that's growing faster or slower? Things are kind of on track, I guess, with your expectations.
spk07: Yeah. Excellent question, Margaret. This is Nadine, by the way. Two things. Number one, we've said previously that accounts that have been treating patients with barostem for more than two years are doing more patients in average per quarter than those who have been treating patients from 12 to 24 months ago. And these are also doing more patients per quarter than their most recent accounts that started treating patients with barostem in the last 12 months. So that led us at the time, and we still stand behind the statement, to conclude that The longer a site is treating patients with barostem, the more they see the positive impact on their patients, the more they can spread the word around the institution to build more referral networks, to strengthen the referral network around them, the more they end up treating patients with barostem per quarter. So that stands. The second dynamic that is interesting, you know, just like in politics, right, everything is played at the local level. So it depends a lot on the local competition between hospitals at a specific geography. And the more you have accounts in the geography, the more the competition starts ramping up and, you know, hospitals trying to market the new therapies that they are offering their patients to the community, to the general cardiologists around them. the more we see the buzz augmenting in that geography and the more we see more sites wanting to come in for the fear of missing out on something big. So that bandwagon effect is real and it happens at the local level, not at the national level. And that is very exciting for us to see.
spk01: Yeah. Okay. That's very helpful. And then I'll sneak one more in since the first one was a little bit of a bust, but Any kind of back and forth discussions you're having with the FDA on label expansion recently? Any kind of color maybe on concerns, requests, and, you know, whether you're confident, I guess, that they won't convene a panel? Thank you.
spk07: You're always able to, you know, get from me some new things. So here is this one. Yes, we did have discussions with FDA prior to the submission. If you recall at your conference, I mentioned publicly that we submitted the PMA supplement to FDA after having a few discussions or interaction with FDA prior to that. We became comfortable with where we stood with them. We prepared the dossier with all of the evidence, the totality of evidence, and we submitted. Now, the process is for FDA to take 100 days and then come back with questions. And we're in this period right now where we're waiting for them to do all of the analysis they need and come back to us with questions. That does not mean that we are not having other conversations with FDA in parallel, but not specific on the labeling of the PMA supplement.
spk01: Got it. I appreciate that, and congrats, guys.
spk10: Thank you, Margaret.
spk04: Thank you. Our next question comes from Bill Palmbiak with Canaccord Genuity. Please proceed with your question.
spk09: Hey, great. Thanks. Good evening. A couple questions for you here. Just one, I want to understand the reimbursement. When we read through the ops, I guess we saw a T code, 0266T, that was reimbursing $30,400, and you're referencing $26,000, I think, on reimbursement. What code are you referencing on that in the ops? I'm just trying to figure that one out, what we missed.
spk07: Yeah, Bill, this is Nadim, by the way, and let me pronounce your name correctly. Listen, great question. So, yes, it is the 0266T. That is the reimbursement for the device and the procedure. And what Jared is mentioning is the ASP of the device net of the procedure. Now, when you say a 30,400, that's a national average. So sites at major cities. are more expensive and reimbursement could go up all the way to $40,000. And smaller hospitals in rural areas in the United States where the cost of living is lower might go lower than $30,000. So that drives companies to be, let's say, strategic in the account targeting in here. And that's why you see often novel therapies are targeting the big major metropolitan areas because the reimbursement is higher there. So when we're quoting $30,000, when you look at the average in the sites where BarroStem is currently utilized, it's probably higher than $30,400. I'm sorry, will be next year, talking about 2024. Jared, do you want to add something?
spk09: It reminds us what's the reimbursement today.
spk07: Yeah, today is slightly below $3,000, but we have on top of it the transitional pass-through payment that adds another $10,000, $15,000 on top of it. And this is the TPT, the transitional pass-through that expires by the end of this year. We've been granted this for three years, and that helps novel therapies to be adopted. And that's the process in the United States. Now, if I compare and contrast with another product similar to ours. Let me take the example of Inspire Medical, right? They did not have a transitional pass-through when they started their product, and they learned to live within that $30,000 envelope that we're talking about today. In our case, we got lucky. We received that transitional pass-through payment, but it's only for three years, and now it's arriving toward the end of it by the end of this year.
spk10: Okay.
spk09: And then I was wondering if you could talk about the bat wire, you know, now that you've had the submission and you're in the 100 days, your regulatory team, I would assume, you know, had a whole weekend off and then, you know, are you kind of re-energized the bat wire or how should we think about that program?
spk07: As a company, yes, we're super energized. But the reality on the ground is more nuanced and more difficult than this. You know, the enrollment rate for Batwire has been more challenging than we have anticipated. I think post-COVID, patients are a little bit wary regarding experimental approaches. And when they have a choice for a given indication between an FDA-approved product like Barostem, that is already minimally evasive, and enrolling in a clinical trial with an uncertain outcome because not FDA approved for bat wire, it seems that the majority of the patients right now are preferring to go the safer route and selecting barostem. And we've seen this in the numbers, we've seen this in our growth in barostem, but the price we're paying right now is a slower enrollment in bat wire. That said, while we remain blinded to the efficacy of PetWire, we see the safety on a daily basis, and we report on the safety of patients every five or 10 patients to FDA. And so far, we're super, super happy with how safe that approach is for patients. But again, let me remind everybody, we're still blinded to the efficacy of this. And as we proceed forward with the trial, we'll provide more updates when we have something more to say, Bill, about this.
spk09: Yeah, on that topic, do you have any kind of updated thoughts on when you might complete enrollment or how far through enrollment you are, just to give us an idea? And thanks for taking my questions.
spk07: Yeah, no, let me punt on this. We'll provide a longer update, I believe, probably next quarter when we'll learn a little bit more about the trend in the study in terms of enrollment. But what you hear from me here is the concern about the fact that the enrollment has been more challenging than we anticipated and is going slower.
spk09: Okay, great. We look forward to seeing you at our conference in two weeks. Thanks.
spk10: I look forward to it, Bill. Thank you for the invite.
spk04: Thank you. Our next question comes from Alex Novak with Craig Hallam. Please proceed with your question.
spk11: Okay, great. Good afternoon, everyone. I wanted to follow up to the couple of questions on the proposed OPPS that was out there. We talked a bit on pricing, but I actually want to pivot just a little bit. Just trying to understand, how is Medicare thinking about Barrow Stem? Were you just surprised that there was no plain no mention of Barrow Stem anywhere within the documents? And I'm trying to understand, is that an outright denial of getting Barrow Stem a new APC code, or that simply that the proposal for the new APC code just didn't make it into the proposed documents yet?
spk07: Alex, how are you? It's a great question, by the way. I wish I know the answer. Would I prefer to have a negative comment explicit, which often what they do is they will say, yep, we received this request and nope, we will not give it to you, or have them stay silent on it? I don't know which one is better, seriously. I think silent is better. It leaves the door open to have the dialogue with the panel in August. But it's hard to know. It is really hard to know, Alex.
spk11: Well, getting a new indication or an upgraded label expansion at FDA, will that have any influence at all on the APC code that Medicare will ultimately choose in the final documents?
spk07: You know, the way Medicare is structured, they have, think about it as three different pillars that are independent. You have the coding, the payments, and the coverage. The labeling expansion will impact coverage discussions. It would not impact payment, and it will not impact coding. Payment under the CMS regulations is driven almost entirely by the cost of charges that hospitals report back to CMS that CMS analyzes. So CMS tries to put therapies into buckets so that they don't have to price each one, each device or each flavor of a device different. They put them in bands or in buckets, and they try to price these buckets based on the geometric average of the claim data that they receive from hospitals. And it's not linked to an efficacy data or labeling or anything like that, unfortunately.
spk11: Okay, that makes sense. And then, obviously, we've seen some really strong sales results, you know, this year, last year as well. You've been adding sales territories, three on average per quarter. What is the right number? What is the sales leadership team asking for? And then this might be a little bit of a follow-on question for you. What's the cash flow breakeven? You know, just provide some more insights on how we get there with the capital and the resources on hand. When do we start to see the optics grow, start to slow? I think it sounds like 2024, but just current thoughts there.
spk07: Excellent two questions, Alex. Let me take the easy one and I'll leave the difficult one to Jared. So yeah, we believe the right number is three per quarter. As we looked into our path to getting to cash flow break-even without needing to raise dilutive capital, it's a cone of possibilities. But if we go too slow in the growth rate, we will never get there. And if we go too fast, will burn the cash way too soon before getting there. Why is that? It's because when you hire a rep, it takes six, nine, 12 months for the rep to be trained, to start creating the relationships in the field, and to take the accounts through the contracting process that we know take many months until they can treat their first patients. So during that period, you're carrying the cost of the rep, the territory manager, without getting real benefit from additional sales in that first year. So if you load it up too much upfront, you burn through the cash sooner without being able to get to the cashflow break even. If we were having, you and I, this conversation five years ago where the market was rewarding growth, irrespective of the need to raising capital, Maybe that would have been our strategy. But today, in this current environment where investors are focusing on the ability of companies to generate cash flow, this did not appear to be the right strategy for us to grow faster than this. But let me turn to Jared to walk you through the thinking process.
spk08: Yeah, Alex, it's something we've been talking about for a while was 2023 was the flatlining year from a cash burn perspective. So the number that we burned in 22, the expectation was that we would be burning a number that was very similar to that in 2023 based on the guidance that we had put out at the beginning of the year. As we march into 2024 and beyond, that's where we see that cash burn number coming down and seeing the leverage in the model start to play out where the growth in OPEX is a smaller dollar amount than the growth in revenue. And that's how we get to that cash flow breakeven number.
spk10: I appreciate the update. Thank you. Thank you, Alex.
spk04: Thank you. Our next question comes from Frank Tackety with Lake Street Capital Markets. Please proceed with your question.
spk05: Great, thanks for taking the questions. I wanted to ask slightly differently related to the BHF data. I know it came up that was there any negative impact from that data and fully understanding it's not on label right now, so it can't be marketed and it's off label technically, but was there on the flip side any positive impact that you potentially saw from active implanting centers that were familiar with the data? I know as a patient, if you can find your way to 34% reduction to LVAD transplant, That's probably something you ask your physician about despite or whether or not it is or is not on label. So maybe any tailwind as it relates to that that you may have seen at some of your active implanting centers.
spk07: Hey, Frank, excellent question. So when we unblinded the data and the data was presented at the late breaker, it's a it's a common practice to have the steering committee present the data as well to the investigators who participated in the trial as a courtesy. And many of those investigators are current customers, you know, current Parastem customers. And the feedback we got at that time was, very positive, super encouraging. Yes, there were questions about, okay, what does it mean not to have met the primary endpoint, but the focus on the long-term safety, the durability of the symptomatic improvement. And, you know, when you look at the totality of evidence, particularly as compounded with the win ratio analysis that was positive and the trend in the mortality data, people felt very good about the effect. And we spoke about it publicly back then, but I think probably, you know, it might have appeared to be a bit defensive when we were trying to convey a positive message. And, uh, you know, the negative, there was some negative sentiments around, around the messaging that we did in any way, uh, that positive messaging we believe has helped carry the day for us and is the reason why we're seeing that trajectory change slightly this year versus last year in terms of growth. So with this in mind, yes, we believe it had a positive impact on our growth. Now, We're talking here about the same patient population. We're not talking outside of the current labeling. Listen, we estimated, even with our conservative method back when we did the IPO two years ago, that there were 55,000 new patients every year that could be eligible for therapy. Those are new patients every year. So if you don't treat them this year, there'll be another 55,000 the next year and so forth. And right now, what are we talking about? Less than 1,000 or 2,000 patients we're treating every year. That's still a single-digit percentage point of this population. So the key here is to give more ammunition to the sites who are treating patients with barostem when they, in turn, preach to the referring physicians about the virtues of barostem. That's the key element in here is how can a barostem treating center can start spreading the word to the referral network about the benefits of barostem. And that's what the data allows for those who have been able to see it at scientific meetings. Did I answer your question, Frank?
spk05: Yep, that's perfect. And then maybe just one other one on utilization. I was hoping you could maybe approximate what percentage of your 140 or so are running at 12 or more implants per year, just trying to get a sense for how that average is computed and how many of your centers are really contributing to bringing that average up.
spk08: Yeah. Hey, Frank, I'll take that one. One thing I'd like to call out for everybody is we have 140 active implanting centers. Just based on the additions we've done over the last four quarters or so, half of them were added in the last year. So that means only 70 of the centers have been with us more than 12 months as of the end of June this year. So we don't have a lot of centers that have reached that two plus year marker. But we are seeing really good signs for the centers that have been with us two-plus years to see that average implanting ratio reach that long-term average of one per month or 12 per year that you're asking about. So we're not going to go into the details on the exact number, but, you know, we've talked about it in the past. It's more than a couple handfuls of centers that have started reaching that average in the more recent quarters.
spk05: Great. That's helpful.
spk10: I'll stop there. Thanks for taking the questions. Thank you so much. Thanks, Frank.
spk04: Thank you. There are no further questions at this time. I would like to turn the floor back over to Nadeem for closing comments.
spk07: Oh, yeah. Thank you, operator, and thanks, everyone, for joining us for our second quarter earnings call. We appreciate your ongoing support, and we look forward to updating you on our progress on our next update.
spk04: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
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