Q4 2024 CVRx Inc Earnings Call

February 4, 2025

Prior operator assistance, Please press star zero on your telephone keypad.

As a reminder, this conference is being recorded.

Mike Vallely: It is now my pleasure to introduce Mike Vallely from IPR Health care.

Mike Vallie, Jared Oasheim, Mike Vallie, Unknown Executive

Mike Vallely: Good afternoon. Thank you for joining us today for <unk> fourth quarter and full year 2024 earnings conference call.

Kevin Hikes: Joining me on today's call are the company's President and Chief Executive Officer, Kevin Hikes, and Chief Financial Officer Jarrett Ocean.

Kevin Hikes: The remarks today will contain forward looking statements, including statements about financial guidance.

Kevin Hikes: The statements are based on plans and expectations as of today, which may change over time.

Kevin Hikes: 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.

Kevin Hikes: I would now like to turn the call over to <unk>, President and Chief Executive Officer, Kevin <unk>.

Kevin Hikes: Thanks, Mike Good afternoon, and thank you for joining us I'm pleased to report another quarter of strong performance driven by continued solid execution within our U S heart failure business.

Kevin Hikes: We delivered total revenue of $15 3 million representing growth of 36% over the fourth quarter of 2023 with U S heart failure growth growing 41%.

Kevin Hikes: We continue to be very excited about the trajectory of the business and the positive impact that <unk> therapy continues to have on patients.

Throughout 2024, we made significant progress building, a strong foundation to support future growth.

Kevin Hikes: After some disruption in the sales force early in the year, we stabilized the sales organization brought in new commercial leadership and made significant steps towards building out a world class sales team.

Kevin Hikes: This team is now implementing our go to market strategy focused on driving deeper penetration within new and existing accounts by implementing a disciplined targeting strategy and a program focused selling approach.

Kevin: I would now like to turn the call over to <unk>, President and Chief Executive Officer, Kevin <unk>.

Kevin: Thanks, Mike Good afternoon, and thank you for joining us I'm pleased to report another quarter of strong performance driven by continued solid execution within our U S heart failure business.

Kevin Hikes: The team's execution along with our expansion to 48 territories in the United States allowed us to end the year with 223 active implanting centers up from 178 at the end of 2023.

Kevin: We delivered total revenue of $15 $3 million representing growth of 36% over the fourth quarter of 2023 with U S heart failure growth growing 41%.

Kevin Hikes: Beyond the build out and optimization of our commercial team, we focused on addressing key barriers to adoption by improving patient access to the therapy.

Kevin: We continue to be very excited about the trajectory of the business and the positive impact that barristan therapy continues to have on patients.

Kevin Hikes: Increasing education and awareness among physicians advanced practice providers and patients and developing a more robust portfolio of clinical evidence.

Kevin: Throughout 'twenty 'twenty four we made significant progress in building a strong foundation to support future growth after.

Kevin Hikes: Starting with patient access we made substantial progress throughout 2024 on a number of important initiatives.

Kevin: After some disruption in the sales force early in the year, we stabilized the sales organization brought in new commercial leadership and made significant steps towards building out a world class sales team.

Kevin Hikes: In the final 2025 hospital outpatient prospective payment system rule.

Kevin Hikes: CMS maintained various Tim in the new technology APC $15 80 for 2025, preserving the current reimbursement level of approximately $45000 for outpatient procedures.

This team is now implementing our go to market strategy focused on driving deeper penetration within new and existing accounts by implementing a disciplined targeting strategy and a program focused selling approach.

Kevin Hikes: His decision once again appropriately recognizes the resource requirements associated with the barrels stemmed implant procedure and supports continued patient access.

Kevin: The team's execution along with our expansion to 48 territories in the United States allowed us to end the year with 223 active implanting centers up from 178 at the end of 2023.

Kevin Hikes: On an inpatient basis, we successfully secured the reassignment of barrel stem to DRG 276, which took effect in October of 2024.

Beyond the build out and optimization of our commercial team we've focused on addressing key barriers to adoption by improving patient access to the therapy.

Kevin Hikes: This increased the inpatient payment to hospitals from approximately 17% to $23000 to approximately $43000.

Kevin: Increasing education and awareness among physicians advanced practice providers and patients and developing a more robust portfolio of clinical evidence.

Kevin Hikes: We are pleased that hospital reimbursement has now been effectively equalized between inpatient and outpatient settings for 2025 allow.

Kevin: Starting with patient access we made substantial progress throughout 2024 on a number of important initiatives.

Kevin Hikes: Allowing clinicians to treat their patients in the most clinically appropriate setting independent of economic considerations.

Kevin: And the final 2025 hospital outpatient prospective payment system rule.

Kevin: CMS maintained barest him in the new technology, a P. C 15, 84, 'twenty twenty-five preserving the current reimbursement level of approximately $45000 for outpatient procedures.

Kevin Hikes: Regarding coding developments the American Medical Association CPT editorial panel has accepted new category, one CPT codes for <unk> therapy, which we expect to be implemented on January one of 2026.

Kevin: His decision once again appropriately recognizes the resource requirements associated with the barrel stemmed implant procedure and supports continued patient access.

Kevin Hikes: This transition from category three to category one codes is particularly significant as it will eliminate the automatic prior authorization denials associated with category three codes, which payers often considered to be experimental it.

Kevin: Well on an inpatient basis, we successfully secured the reassignment of barrel stemmed to DRG 276, which took effect in October of 'twenty 'twenty four.

Kevin Hikes: It will improve prior authorization throughput and predictability and we will unlock access to new markets, where category. One codes are required for coverage.

Kevin: This increased the inpatient payment to hospitals from approximately 17 to $23000 to approximately $43000.

Kevin Hikes: Importantly, the category one procedure codes will formalized physician payment for the barrels Tim procedure and programming, reducing uncertainty for heart failure physicians and their surgical partners.

Kevin: We are pleased that hospital reimbursement has now been effectively equalized between inpatient and outpatient settings for 2025, allowing clinicians to treat their patients in the most clinically appropriate setting independent of economic considerations.

Kevin Hikes: Our second adoption related initiative focused on increasing awareness among refers and patients regarding the appropriate role for barrels to therapy in the heart failure treatment continuum we.

Kevin: Regarding coding developments the American medical associations C. P. T. Editorial panel has accepted new category, one CPT codes for barristan therapy, which we expect to be implemented on January one of 2026.

Kevin Hikes: We expanded our therapy educational programs, including launching our comprehensive ascend program for heart failure Fellows and piloted programs for referral physicians and affiliated practice providers referred to as AP piece.

Kevin: This transition from category three to category one codes is particularly significant as it will eliminate the automatic prior authorization denials associated with category three codes, which payers often considered to be experimental.

Kevin Hikes: Additionally, our <unk> connect program continued to be highly effective in providing education and prior authorization support to prospective patients.

Kevin Hikes: Our third focus area was developing a more consistent stream of clinical evidence supporting <unk> therapy.

Kevin: We'll improve prior authorization throughput and predictability and will unlock access to new markets, where category. One codes are required for coverage.

Kevin Hikes: Throughout the year, we made progress in publishing additional scientific evidence that more fully describes barrow stems mechanism of action and the wide range of patient benefits.

Kevin: Importantly, the category one procedure codes will formalized physician payment for the barrels Tim procedure and programming, reducing uncertainty for heart failure physicians and their surgical partners.

Kevin Hikes: Several months ago. The first long term post Covid dataset was published by the University of Southern California, which showed a five fold decrease in hospitalization one year. After patients began receiving barrels 10 therapy highly consistent with the pre COVID-19 phase III hope for heart failure data.

Kevin: Our second adoption related initiatives focused on increasing awareness among refers and patients regarding the appropriate role for barrels Tim therapy in the heart failure treatment continuum.

Kevin Hikes: The statistical significance of this result was particularly interesting given that it was based upon a small subset of USC patients who were optimally medically managed.

We expanded our therapy educational programs, including launching our comprehensive ascend program for heart failure Fellows and piloted programs for referral physicians and affiliated practice providers referred to as a P. Pes.

Kevin Hikes: We plan to use real world evidence data to further explore this impact, which we believe will be of interest to the payer community.

Kevin: Additionally, our barrels Tim connect program continued to be highly effective in providing education and prior authorization support to prospective patients.

Kevin Hikes: In summary, we ended 2024 with tremendous momentum delivering growth in U S heart failure revenue and increasing operating leverage through prudent capital deployment.

Kevin: Our third focus area was developing a more consistent stream of clinical evidence supporting <unk> therapy throughout.

Kevin Hikes: With successful navigation of critical reimbursement milestones and growing adoption momentum, we are well positioned to drive strong sustainable growth as barrels team advances towards becoming standard of care for heart failure patients.

Kevin: Throughout the year, we made progress in publishing additional scientific evidence that more fully describes barrels times mechanism of action and the wide range of patient benefits.

Kevin: Several months ago. The first long term post Covid dataset was published by the University of Southern California, which showed a five fold decrease in hospitalization one year. After patients began receiving barristan therapy highly consistent with the pre COVID-19 phase to hope for heart failure data.

Jared: Now I'd like to turn the call over to Jared for a financial review.

Jared: Thanks, Kevin in the fourth quarter total revenue generated was $15 3 million, representing an increase of $4 million or 36% compared to the same period last year.

Jared: Failure revenue in the U S totaled $14 $3 million in the fourth quarter, an increase of 41% on a total of 457 revenue units compared to $10 $2 million in the fourth quarter of last year on 330 revenue units.

Kevin: The statistical significance of this result was particularly interesting given that it was based upon a small subset of U S. C patients who were optimally medically managed.

Kevin: We plan to use real world evidence data to further explore this impact, which we believe will be of interest to the payer community.

Jared: 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 <unk>.

Kevin: In summary, we ended 2024 with tremendous momentum delivering growth in U S heart failure revenue and increasing operating leverage through prudent capital deployment.

Jared: At the end of the year, we had a total of 223 active implanting centers compared to 178 at the end of 2023 and 208 on September 32024. We also had 48 sales territories in the U S. At the end of the year compared to 38 at the end of 2023 and <unk> 45 on <unk>.

Kevin: With successful navigation of critical reimbursement milestones and growing adoption momentum, we are well positioned to drive strong sustainable growth as barrels seem advances towards becoming standard of care for heart failure patients.

Jared: Now I'd like to turn the call over to Jared for a financial review.

Jared: September 32024.

Jared: Revenue generated in Europe was $1 million for the fourth quarter of 2024 in 2023 total revenue units in Europe decreased from 52% in the fourth quarter of 2023 to <unk> 41 in the fourth quarter of 2024 at the end of 2024, we had five sales territories in Europe as compared to six sales territories.

Jared: Thanks, Kevin in the fourth quarter total revenue generated was $15 $3 million, representing an increase of $4 million or 36% compared to the same period last year heart failure revenue in the U S totaled $14 $3 million in the fourth quarter, an increase of 41% on a total of 400.

Jared: 57 revenue units compared to $10 $2 million in the fourth quarter of last year on 330 revenue units.

Jared: As of September 32024.

Jared: Gross profit for the fourth quarter was $12 8 million, an increase of $3 $2 million compared to the fourth quarter of 2023.

Jared: Gross margin for the fourth quarter was 83% compared to 85% for the same period last year.

Jared: Research and development expenses for the fourth quarter were $2 8 million.

Jared: At the end of the year, we had a total of 223 active implanting centers compared to 178 at the end of 2023 and 208 on September 30th 2024. We also had 48 sales territories in the U S. At the end of the year compared to 38 at the end of 2023 and <unk> 45 on <unk>.

Jared: Reflecting a 25% increase compared to the same period last year. This change was primarily driven by a zero point $5 million increase in clinical study expenses zero point $2 million increase in consulting expenses and a <unk> $1 million increase in noncash stock based compensation expense, partially offset by the <unk>.

September 30th 2024.

Jared: Revenue generated in Europe was $1 million for the fourth quarter of 2024 in 2023 total revenue units in Europe decreased from 52 in the fourth quarter of 2023 to 41 in the fourth quarter of 2024 at the end of 2024, we had five sales territories in Europe as compared to six sales territories.

Jared: $2 million decrease in compensation expenses SG&A expenses for the fourth quarter were $22 million representing.

Jared: Representing a 19% increase compared to the same period last year. This change was driven by a $2 $9 million increase in compensation expenses, mainly as a result of increased head count of $1 million increase in noncash stock based compensation expense and a zero point $3 million increase in travel expenses partially.

Jared: As of September 30th 2024.

Gross profit for the fourth quarter was $12 $8 million, an increase of $3 $2 million compared to the fourth quarter of 2023 gross margin for the fourth quarter was 83% compared to 85% for the same period last year Reis.

Jared: Net by a $1 $1 million decrease in advertising expenses.

Jared: Interest expense increased <unk> $9 million to $1 $5 million for the three months ended December 31, 2024 compared to the three months ended December 31, 2023. This increase was driven by the interest expense on higher levels of borrowings under the term loan agreement other income net was $1 one.

Jared: Research and development expenses for the fourth quarter were $2 $8 million, reflecting a 25% increase compared to the same period last year. This change was primarily driven by a zero point $5 million, increasing clinical study expenses zero point $2 million increase in consulting expenses and a zero point $1 million increase.

Jared: $1 million for each of the three months ended December 31, 2024, and 2023. Other income net consisted primarily of income on interest bearing accounts net loss was $10 7 million or <unk> 43 per share for the three months ended December 31, 2024, compared to a net loss of $9 2 million or <unk> <unk>.

Jared: And noncash stock based compensation expense, partially offset by a zero point $2 million decrease in compensation expenses SG&A expenses for the fourth quarter were $22 million, representing a 19% increase compared to the same period last year. This change was driven by a $2 $9 million increasing comping.

Jared: 34 cents per share for the same period last year net loss per share was based on $24 7 million weighted average shares outstanding for the three months ended December 31, 2024, and $20 8 million weighted average shares outstanding for the fourth quarter of 2023.

Jared: <unk> expenses, mainly as a result of increased head count of $1 million increase in noncash stock based compensation expense and a zero point $3 million increase in travel expenses, partially offset by a $1 $1 million decrease in advertising expenses.

Jared: As of December 31, 2024, cash and cash equivalents were $105 9 million for the three months ended December 31, 2024. The company issued approximately 869000 shares of common stock for gross proceeds of $12 $8 million under its at the market offering.

Jared: Interest expense increased zero point $9 million to $1 $5 million for the three months ended December 31, 2024 compared to the three months ended December 31, 2023. This increase was driven by the interest expense on higher levels of borrowings under the term loan agreement other income net was $1 one.

Jared: Now turning to guidance for the full year of 2025, we expect total revenue between $63 million and $65 million, we expect full year gross margin between 83%, 84% and we expect operating expenses between $100 million and $104 million for the first quarter of <unk>.

Jared: <unk> million dollars for each of the three months ended December 31, 2024 in 2023. Other income net consisted primarily of income on interest bearing accounts net loss was $10 $7 million or <unk> 43 per share for the three months ended December 31, 2024, compared to a net loss of $9 2 million or four.

Kevin Hikes: <unk> 25, we expect to report total revenue between 14, five and $15 million I would now like to turn the call back over to Kevin.

Jared: Four cents per share for the same period last year net loss per share was based on $24 7 million weighted average shares outstanding for the three months ended December 31, 2024, and $20 8 million weighted average shares outstanding for the fourth quarter of 2023.

Kevin Hikes: Thank you Gerrit before we open the line for questions I'd like to share our excitement about the opportunities that lie ahead in 2025.

Kevin Hikes: We're entering the year with a strong foundation for growth supported by a clear reimbursement landscape, increasing patient and physician awareness and a growing body of compelling clinical evidence.

Jared: As of December 31, 2024, cash and cash equivalents were $105 $9 million for the three months ended December 31, 2024. The company issued approximately 869000 shares of common stock for gross proceeds of $12 $8 million under its at the market offering.

Kevin Hikes: For 2025, we are focused on three key strategic priorities first we are building a world class sales organization focused on developing sustainable barristan programs with deep therapy adoption. This includes recruiting sales representatives with strong therapy development backgrounds, strengthening our training and onboarding programs and aligning our.

Jared: Now turning to guidance for the full year of 2025, we expect total revenue between $63 million and $65 million, we expect full year gross margin between 83% and 84% and we expect operating expenses between $100 million and $104 million for the first quarter of 'twenty.

Kevin Hikes: Our incentives to support program oriented sales processes to support this evolution, we are implementing a new compensation structure that rewards the key elements of a successful program.

Kevin Hikes: Including consistency of implants, and the development of multiple physician champions at each center.

Kevin: 25, we expect to report total revenue between 14.5 and $15 million I would now like to turn the call back over to Kevin.

Kevin Hikes: Second we will focus on targeting centers with the highest potential to develop sustainable barristan programs. We.

Thank you Gerrit before we open the line for questions I'd like to share our excitement about the opportunities that lie ahead in 2025.

Kevin Hikes: We plan to systematically replicate the elements present in current barrels Tim centers that have achieved the deepest levels of adoption leveraging our learnings from our most successful partnerships.

Kevin: We're entering the year with a strong foundation for growth supported by a clear reimbursement landscape, increasing patient and physician awareness and a growing body of compelling clinical evidence.

Kevin Hikes: Specifically, we are targeting centers that demonstrate three key characteristics.

Kevin Hikes: Large heart failure patient volumes proven adoption of novel heart failure diagnostic devices and a track record of successfully leveraging new cardiovascular therapies to strengthen their cardiovascular service lines.

Kevin: For 2025, we're focused on three key strategic priorities first we're building a world class sales organization focused on developing sustainable barrels can programs with deep therapy adoption. This includes recruiting sales representatives with strong therapy development backgrounds, strengthening our training and onboarding programs and aligning.

Kevin Hikes: Within these centers, we will work to develop clinical champions and administrative partners, who understand the positive impact of <unk> on their cardiovascular service line and we will work with these champions to educate their network of heart failure physicians interventional cardiologist Electrophysiologist and advanced practice providers.

Our incentives to support program oriented sales processes to support this evolution, we're implementing a new compensation structure that rewards the key elements of a successful program, including consistency of implants and the development of multiple physician champions at each center.

Kevin Hikes: Third we will continue to execute on our market development strategy, which addresses three fundamental barriers to adoption.

Second we will focus on targeting centers with the highest potential to develop sustainable barristan programs. We plan to systematically replicate the elements present in current barrels Tim centers that have achieved the deepest levels of adoption leveraging our learnings from our most successful partnerships.

Kevin Hikes: On the therapy awareness front, we're engaging more deeply with peripheral networks surrounding our targeted centers through expanded regional medical education programs, our newly launched <unk> focused programs and our ascend heart failure Fellows program.

Kevin Hikes: These programs represent the full implementation of the successful pilot programs that we ran in 2024.

Kevin: Specifically, we are targeting centers that demonstrate three key characteristics large heart failure patient volumes proven adoption of novel heart failure diagnostic devices and a track record of successfully leveraging new cardiovascular therapies to strengthen their cardiovascular service lines.

Kevin Hikes: Regarding clinical evidence we are developing a steady cadence of publications in two key areas first evidence supporting barrels stems mechanism of action, including reduced sympathetic nerve activity restored cardiac parasympathetic control and anti inflammatory effects and secondly ever.

Within these centers, we will work to develop clinical champions and administrative partners, who understand the positive impact of barristan on their cardiovascular service line and we will work with these champions to educate their network of heart failure physicians interventional cardiologist Electrophysiologist and advanced practice providers.

Kevin Hikes: <unk> of improved clinical outcomes, such as enhanced quality of life reduced hospitalizations and improved ejection fraction.

Kevin Hikes: This evidence will be sourced from a variety of internal and external data sets, including data from our randomized controlled trials.

Kevin: Third we will continue to execute on our market development strategy, which addresses three fundamental barriers to adoption.

Kevin Hikes: The barrels two investigator initiated research program or.

Kevin Hikes: Our multiple internal registries, and importantly, a growing body of real world evidence.

Kevin: On the therapy awareness front, we're engaging more deeply with peripheral networks surrounding our targeted centers through expanded regional medical education programs, our newly launched a P. P focused programs and our ascend heart failure Fellows program.

Kevin Hikes: We intend to present the first results of our first real World data set analysis in early February at the Th team meeting in Boston.

Kevin Hikes: Finally on the patient access front, we will continue to build on our 2024 progress by maintaining appropriate payment levels for both inpatient and outpatient procedures working towards permanent procedural codes and leveraging our long term data to positively impact coverage policies.

Kevin: These programs represent the full implementation of the successful pilot programs that we ran in 2024.

Kevin: Regarding clinical evidence, we're developing a steady cadence of publications in two key areas first evidence supporting barrels tim's mechanism of action, including reduced sympathetic nerve activity restored cardiac parasympathetic control and anti inflammatory effects and secondly evidence of.

Kevin Hikes: We believe that we are well positioned to drive strong sustainable efficient growth in the coming year as barrels steam advances towards becoming standard of care for patients suffering from the debilitating symptoms of heart failure.

Kevin: Improved clinical outcomes, such as enhanced quality of life reduced hospitalizations and improved ejection fraction.

Kevin Hikes: Now I'd like to open the line for questions operator.

Kevin: This evidence will be sourced from a variety of internal and external data sets, including data from our randomized controlled trials.

Kevin Hikes: Thank you we will now be conducting a question and answer session.

Kevin Hikes: You'd like to ask a question. Please press star one on your telephone keypad.

Kevin: The barrels Tim investigator initiated research program or.

Kevin Hikes: Confirmation tone will indicate your line is in the question queue.

Kevin Hikes: Press Star two if you'd 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.

Kevin: Our multiple internal registries, and importantly, a growing body of real world evidence.

Kevin: We intend to present, the first results of our first real World data set analyses in early February at the Th team meeting in Boston.

Kevin Hikes: One moment, please while we poll for questions.

Kevin: Finally on the patient access front, we will continue to build on our 2024 progress by maintaining appropriate payment levels for both inpatient and outpatient procedures working towards permanent procedural codes and leveraging our long term data to positively impact coverage policies.

Speaker Change: Thank you. Our first question is from Robbie Marcus with Jpmorgan. Please proceed with your question.

Rohit: Hi, This is actually rohit on for Robbie Thanks for taking our question two for me. The first is just.

Kevin: We believe that we are well positioned to drive strong sustainable efficient growth in the coming year as barrels steam advances towards becoming standard of care for patients suffering from the debilitating symptoms of heart failure now I'd like to open the line for questions operator.

Speaker Change: Just starting off with revenue guidance for next year, and specifically what's assumed as far as new center adds in utilization utilization is probably the biggest lever in the model. So was hoping you could also just touch more on some of the specific things you're doing to drive this up on a per center basis, and then I have a follow up.

Kevin: Thank you, we'll now be conducting a question and answer session.

Rohit: Okay.

Rohit: Hi, Ron This is Jared I'm happy to take the first part of that question. So on the guidance for 2025.

Speaker Change: Who'd like to ask a question. Please press star one on your telephone keypad.

Speaker Change: Information tone will indicate your line is in the question queue. You May press star two if you'd 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.

Speaker Change: The revenue levels of 63% to $65 million.

Speaker Change: There's a few components that are included into coming up with that number. The first is the average selling price.

Speaker Change: One moment, please while we poll for questions.

Speaker Change: Our base expectation within the guide we're assuming similar asps that we saw in 2024 for the U S heart failure business, which is approximately $31000 per device.

Speaker Change: Thank you. Our first question is from Robbie Marcus with Jpmorgan. Please proceed with your question.

Speaker Change: The second piece is the number of net new active implanting centers that we'd be adding on a quarterly basis and as we mentioned at your conference earlier. This year, we're expecting to see high single digits to low double digit net adds on a quarterly basis.

Speaker Change: Hi, This is actually <unk> on for Robbie Thanks for taking our question two for me. The first is just.

Speaker Change: And when factoring in both of those items to get to the revenue totals that we guided towards we're expecting to see the average revenue units or the utilization at these accounts get back to the levels. We just delivered in Q4 of 2024 after seeing a slight dip here in the firm.

Speaker Change: Okay.

Speaker Change: Hi, Robin this is Jared I'm happy to take the first part of that question. So on the guidance for 2025 are.

Speaker Change: Quarter due to seasonality.

Speaker Change: The revenue levels of $63 million to $65 million.

Speaker Change: There's a few components that are included into coming up with that number. The first is the average selling price.

Speaker Change: Great. Thanks, that's helpful. And then just on Opex I think you came in a little bit above the guide for the year of about 100 million by $2 million above.

Speaker Change: For our base expectation within the guide we're assuming similar asp's that we saw in 2024 for the U S heart failure business, which is approximately $31000 per device.

Speaker Change: And then obviously, you're expecting to see a $102 million to $104 million in 2025, which is a slight uptick from that so can you just talk more about what's assumed between SG&A and R&D and some of the spending priorities and just what gives you confidence that you'll be able to kind of maintain that level as we progress throughout the year.

Speaker Change: Yeah. So we landed just north of $102 million of Opex for 2024, and as a reminder included in that total is a one time stock option modification expense related to the first quarter or that was recognized in the first quarter of 2024 of roughly $8 $4 million.

Speaker Change: So the growth that we're expecting from 24 to $25 when removing the one time item is around eight or $9 million at the midpoint of our guide the vast majority of that spend in 2025 or the growth in spend is going to be going into the sales and marketing organization, we're continuing to.

Speaker Change: Quarter due to seasonality.

Speaker Change: Great. Thanks, that's helpful. And then just on Opex I think you came in a little bit above the guide for the year of about 100 million 2 million above.

Speaker Change: To add around three new territories on a quarterly basis throughout 2025, and we will continue to spend on other marketing activities as well. So the vast majority of that growth in Opex is expected to go into sales and marketing and as we mentioned before our expectation here is to start to see.

Speaker Change: So and then obviously, you're expecting to see $102 million to $104 million in 2025, which is a slight uptick from that so can you just talk more about what's assumed between SG&A and R&D and some of the spending priorities and just what gives you confidence that you'll be able to kind of maintain that level as we progress throughout the year.

Speaker Change: Some increase in utilization at these centers, but it doesn't require a significant uptake to see some leverage play out in this model long term.

Speaker Change: Yes.

Speaker Change: Great. Thank you so much.

Speaker Change: Thank you.

Speaker Change: Thank you. Our next question is from Margaret Katherine with William Blair. Please proceed with your question.

Speaker Change: We're expecting from 24 to 25, when removing the one time item is around eight or $9 million at the midpoint of our guide the vast majority of that spend in 2025 or the growth in spend is going to be going into the sales and marketing organization, we're continuing to expect to add around.

Speaker Change: Hi, everyone. This is mccauley on for Margaret Tonight, Thanks for taking our questions.

Speaker Change: You spoke to aligning the sales rep compensation around going deeper obviously within these target high volume accounts and driving those more predictable referral pattern. So first wondering if thats officially been rolled out to the entire sales force now how has that been received and Kevin I know you were barely.

Speaker Change: Three new territories on a quarterly basis throughout 2025, and we will continue to spend on other marketing activities as well. So the vast majority of that growth in Opex is expected to go into sales and marketing and as we mentioned before our expectation here is to start to see some increase.

Speaker Change: And the role.

Speaker Change: When the disruption happened in the first quarter of last year about what did you change. This time around to ensure you retained the strong sales team that you've built thus far.

Speaker Change: <unk> in utilization at these centers, but it doesn't require a significant uptake to see some leverage play out in this model long term.

Thank you Mikael I appreciate the question.

Speaker Change: It's quite pertinent as we look back on what happened a year ago. This week in fact, so I'd say theres sort of three key differences number one the process through which the program was developed and rolled out and introduced to the team was radically different this year, we started with our top sales leaders and their top lieutenants and.

Speaker Change: Great. Thank you so much.

Speaker Change: Thank you.

Speaker Change: Thank you. Our next question is from Margaret KBR.

Speaker Change: William Blair. Please proceed with your question.

Mccauley: Hi, everyone. This is mccauley on for Margaret Tonight, Thanks for taking our questions.

Speaker Change: Ultimately, our sales counsel and and collaboratively work with them to develop the program.

Mccauley: You spoke to aligning the sales rep compensation around going deeper obviously with any of these target high volume accounts and driving those more predictable referral patterns. So first I'm wondering if that's officially been rolled out to the entire Salesforce now how has that been received and Kevin I know you were barely in.

Speaker Change: For the year ahead, we then rolled it out in succession to larger and larger groups within the sales organization, culminating with the rollout.

Saturday of this last weekend at our global sales meeting and so the process was far more inclusive and did not involve the sort of surprised that caused some of the disruption last year.

Kevin: The role.

Speaker Change: Secondly, I think the key difference the structure is in fact, the core elements are the same and it's clean and simple and understandable and driven by revenue, but this year. We've now built around that core revenue driver a number of program related kickers or accelerators that relate to the consistency of implants or the.

Kevin: When the disruption happened in the first quarter of last year about what did you change. This time around to ensure you retained the strong sales team that you've built thus far.

Mikael: Thank you Mikael I appreciate the question.

Mikael: It's quite pertinent as we look back on what happened a year ago. This week in fact, so I'd say theres sort of three key differences number one the process through which the program was developed and rolled out and introduced to the team was radically different this year, we started with our top sales leaders and their top lieutenants and Ulta.

Speaker Change: Diversification of Rivera referral sources around the center or the or building redundant surgical partners within our centers. So again trying to really start to drive behaviors that we believe will lead to these much more productive deep adopting predictable centers I would say the third difference as it was received resoundingly well.

Mikael: Our sales counsel and and collaboratively work with them to develop the program for.

Speaker Change: This last weekend versus a year ago, which was not exactly.

Mikael: For the year ahead, we then rolled it out in succession to larger and larger groups within the sales organization, culminating with the rollout.

Speaker Change: Well received by our team. So we're pleased that the reception. We got we have a team that's in the field. This week excited about the year ahead and energized by their top line.

Mikael: Saturday of this last weekend at our global sales meeting and so the process was far more inclusive and did not involve the sort of surprised that caused some of the disruption last year. Secondly, I think the key difference. The structure is in fact, the core elements are the same and it's clean and simple and understandable and driven by revenue, but this year.

Speaker Change: That's great to hear and then maybe just one for Jared.

Speaker Change: I think.

Speaker Change: In our past conversations you've talked about expecting that cash burn to decrease year over year. This year.

Speaker Change: But as we look at the cadence throughout the year I think we've historically seen that step up in Q1 around 10, and a half to call. It $11 million. So is that similar to how we should be thinking about it as we entered this year and then sequential decreases.

Mikael: We've now built around that core revenue driver a number of program related kickers or accelerators that relate to the consistency of implants or the diversification of Rivera referral sources around the center or the or building redundant surgical partners within our centers. So again.

Speaker Change: Throughout the remainder of the year.

Speaker Change: Yes, that's exactly right Mac, our expectation is that we will see a step up in the cash burn in the first quarter, which is pretty typical for what we've seen in the past as we pay out our annual bonuses and have other one time spend that goes out the door and then from the first quarter, we would expect that cash burn to be coming down to where our lowest cash.

Mikael: Trying to really start to drive behaviors that we believe will lead to these much more productive deep adopting predictable centers I would say the third differences. It was received resoundingly well this last weekend versus a year ago, which was not exactly.

Speaker Change: <unk> would be expected in the fourth quarter and overall with the guidance provided our expectation is that our annual cash burn would be coming down in 2025 as compared to 2024.

Mikael: Well received by our team. So we're pleased that the reception. We got we have a team that's in the field. This week excited about the year ahead and energized by their top line.

Speaker Change: Great. Thanks for your answer your question.

Jared: That's great to hear and then maybe just one for Jared.

Speaker Change: Thank you.

Mikael: I think.

Speaker Change: Our next question is from Bill <unk> with Canaccord Genuity. Please proceed with your question.

Mikael: In our past conversations you talked about expecting that.

Mikael: Cash burn to decrease year over year this year.

Bill: Hey, great. Thanks, Good evening, thanks for taking my questions.

Mikael: If you look at the cadence throughout the year I think we've historically seen that step up in Q1 around 10, and a half to call. It 11 million. So is that similar to how we should be thinking about it as we entered this year and then sequential decreases.

Bill: Just you've given us a lot of clarity and information on the plans you're putting in but.

Bill: If you look at the hurdles for the Hff's specialists out there I mean, that's the biggest kind of.

Bill: Thing left in this.

Mikael: The remainder of the year.

Bill: That you need to address to really get the business to grow significantly, but what are you doing to get them to understand that therapy versus drugs and other options.

Bill: <unk>.

Bill: Is this something the programs youre putting in place.

Speaker Change: Then from the first quarter, we would expect that cash burn to be coming down to where our lowest cash burn would be expected in the fourth quarter and overall with the guidance provided our expectation is that our annual cash burn would be coming down in 2025 as compared to 2024.

Bill: It sounds like this is something that's more of a gradual then kind of a significant inflection point.

Bill: Sure I'll take it thanks Bill.

Speaker Change: So thats a good question, we've talked at length over the last year about what we believe are the three key barriers to adoption in the minds of the heart failure physicians and the general cardiologists that manage earlier stage heart failure failure in the community to three barriers as a reminder, our awareness of the therapy itself of the outcomes that can be achieved in <unk>.

Speaker Change: Great. Thanks again for your question.

Speaker Change: Thank you.

Speaker Change: Our next question is from Bill <unk> with Canaccord Genuity. Please proceed with your question.

Bill: Hey, great. Thanks, Good evening, thanks for taking my questions.

Bill: How it might fit into a heart failure disease continuum.

Bill: You've given us a lot of clarity and information on the plans, you're putting them, but you know if you.

Bill: The second is developing the evidence that these clinicians need to feel comfortable and confident in prescribing the therapy in different physicians have different degrees of conservatism and different data needs in order to get over the hump and so we're continuing to invest aggressively in both clinical data as we've discussed around.

Bill: Look at the hurdles for the HFF specialists out there I mean, that's the biggest kind of.

Bill: Thing left in this.

Bill: That you need to address to really get the business to grow significantly, but what are you doing to get them to understand that therapy versus drugs and other options and <unk>.

Bill: Quality of life, and hospitalization and other clinical endpoints, but also the mechanistic the physiologic underpinnings of the therapy. So that they can truly understand how and why it works.

Bill: <unk>.

Bill: Is this something the programs youre putting in place.

Bill: It sounds like this is something that's more of a gradual then kind of a significant inflection point.

Bill: Third area is patient access in these clinicians wanted to be confident that if they prescribe this therapy to a patient.

Bill: Sure I'll take that thanks Bill.

Speaker Change: So that's a good question we've talked at length over the last year about what we believe are the three key barriers to adoption in the minds of the heart failure physicians and the general cardiologists that manage earlier stage heart failure failure in the community to three barriers as a reminder, our awareness of the therapy itself of the outcomes that can be achieved in <unk>.

Bill: There's a decent chance that that patient payer of their insurer will cover it.

Bill: And so it's really and as you pointed out it's a little bit like air cover for our troops on the ground. None of these are.

Bill: Specific inflection points per se, but this is a constant whittling down of the barriers that we see in the market over time, and it will get better and better but it's something we'll be doing on all three of those fronts for some time to come.

Bill: How it might fit into a heart failure disease continuum.

Bill: Okay and then just.

Bill: One with the increased in patient reimbursement just have you seen a shift in the business with that now that Youre equalizing that and then two is just internationally.

Bill: Oster territory, that's been pretty consistent for a long time do you plan on replacing that territory or was it an unprofitable unprofitable country or geography, or how should we think about that going forward and thanks for taking my questions.

Speaker Change: Thanks for the question Bill first on the reimbursement front. So we do have internally reported metrics that we're tracking on site of service between inpatient and outpatient and we did not see a material shift in where procedures were being done in the fourth quarter. After.

Bill: Third area is patient access in these clinicians wanted to be confident that if they prescribe this therapy to a patient there's a decent chance that that patient payer their insurer will cover it.

Bill: And so it's really and as you point out it's a little bit like air cover for our troops on the ground. None of these are.

Speaker Change: That new inpatient code went live in October However, we will actually receive the CMS reported data for multiple quarters to confirm that we actually got it right based on our internal reports for inpatient versus outpatient. So I think it's something that we're going to continue to track over the next couple of quarters and see if there ends up being.

Bill: Okay and then just.

Bill: One with the increased in patient reimbursement just have you seen a shift in the business with that now that Youre equalizing that and then two is just internationally you lost a territory that's been pretty consistent for a long time do you plan on replacing that territory or was it in them.

Speaker Change: The shift in where patients are being treated when they receive a barrel stem on the <unk> side, we did see a reduction in the number of territories from six at the end of September down to five at the end of December that was a decision on our part to pull back a little bit in spending in Europe.

Bill: Profitable unprofitable country or geography, or how should we think about that going forward and thanks for taking my questions.

Kevin Hikes: <unk> on the level of revenue that was being generated over there. So it's same as Kevin mentioned for the barriers to adoption in the U S. There are similar barriers to adoption on the <unk> side of the business, we're not investing significantly to reduce those barriers, but we will continue to put efforts forward. There in the meantime, I think our expectation.

Bill: Thanks for the question Bill Yeah first on the reimbursement front. So we do have internally reported metrics that we're tracking on site of service between inpatient and outpatient and we did not see a material shift in where procedures were being done in the fourth quarter. After.

Kevin Hikes: Is that the revenue levels would stay relatively flat despite seen territories dropped by one.

Bill: That new inpatient code went live in October However, we will actually receive the CMS reported data for multiple quarters to confirm that we actually got it right based on our internal reports for inpatient versus outpatient. So I think it's something that we're going to continue to track over the next couple of quarters and see if there ends up being a <unk>.

Kevin Hikes: Thanks.

Thank you.

Speaker Change: Our next question is from Matthew O'brien with Piper Sandler. Please proceed with your question.

Speaker Change: Hi, This is on for Matt. Thank you for taking my question.

Bill: Shifting where patients are being treated when they receive a barrel stem on the O U S side, we did see a reduction in the number of territories from six at the end of September down to five at the end of December that was a decision on our part to pull back a little bit in spending in Europe based on the.

Speaker Change: Just to start off.

Speaker Change: We see that you exited Q4 with a record high number of units per center or at least over the past few years and could you speak to what drove that performance in the quarter and whether youre seeing.

Speaker Change: Great or you think it means new target center there is that historically, you've talked about the pause in the delay from the from the older centers.

Bill: The level of revenue that was being generated over there. So it's same as Kevin mentioned for the barriers to adoption in the U S. Theres similar barriers to adoption on the O U S side of the business, we're not investing significantly to reduce those barriers, but we will continue to put efforts forward. There in the meantime, I think our expectation is that the <unk>.

Speaker Change: Hey, Samantha happy to take that one yeah, we did see an increase in the number of revenue units per active implanting center in the fourth quarter that was above levels that we had seen throughout the rest of 2024 I think part of this is some of the work that Kevin has been doing and employ.

Bill: The new levels would stay relatively flat despite seen territories dropped by one.

Speaker Change: The team to do since he joined a year ago is starting to come forward. We're focused on getting the right centers activated and where the centers maybe arent the right target for us, we're allowing them to sunset. So part of this is making sure we're removing the centers that arent productive.

Bill: Thanks.

Bill: Thank you.

Speaker Change: Our next question is from Matthew O'brien with Piper Sandler. Please proceed with your question.

Speaker Change: Hi, This is Joe Munda on for Matt. Thank you for taking my question I guess to start off.

Speaker Change: Out of the denominator from that calculation I think the other piece of this is that we've hired a lot of really good individuals in 2024 that helps to educate physicians and <unk>. So that they understand the benefit of this this therapy, allowing us to see that revenue unit per center increase.

Speaker Change: We see that you exited Q4 with a record high number of units per center or at least over the past few years could you speak to what drove that performance in the quarter and whether youre seeing.

Speaker Change: Or you think it means new target center. There is that historically you talked about the pod delay from the from the older centers.

Speaker Change: Here in the fourth quarter.

Speaker Change: Great. Thank you and then just one more on guidance for the year Q1, obviously implies a slight deceleration.

Speaker Change: After over quarter.

Speaker Change: Could you talk to the rest of that particular cadence throughout the rest of the year.

Speaker Change: Yes happy to cover that yes, we are expecting a little bit of seasonality to hit as we go from Q4 to Q1, it's something that we've seen with other companies as they approach this $50 million revenue Mark and something that we did experience as we look back to Q1 of 2024.

Speaker Change: Team to do since he joined a year ago is starting to come forward, we're focused on getting the right centers activated and where the centers maybe arent the right target for us, we're allowing them to sunset. So part of this is making sure we're removing the centers that arent productive.

Speaker Change: So expecting to see a slight dip in revenue compared to what we just delivered for the fourth quarter as we go throughout the rest of the year in 2025, our expectation is that we'd see pretty consistent growth from what we will deliver in the first quarter throughout the rest of the year. So we're not expecting any other dips or.

Speaker Change: Out of the denominator from that calculation I think the other piece of this is that we've hired a lot of really good individuals in 2024 that helps to educate physicians and AP piece. So that they understand the benefit of this this therapy, allowing us to see that revenue unit per center increase here.

Speaker Change: Seasonality to be impacting the business.

Speaker Change: In the fourth quarter.

Speaker Change: Yeah.

Speaker Change: Thank you.

Speaker Change: Great. Thank you and then just one more on guidance for the year.

Speaker Change: Thank you.

Speaker Change: Our next question is from Frank <unk> with Lake Street Capital markets. Please proceed with your question.

Speaker Change: One obviously implies a slight deceleration.

Speaker Change: Quarter over quarter could.

Speaker Change: Could you talk to the rest of that particular cadence throughout the rest of the year.

Speaker Change: Great. Thanks for taking the questions I had kind of a round point to that you've talked about kind of priorities for 2025 about sustainable barrels stem programs I heard the comments around the large heart very volumes appetite to adopt new novel devices, but I was hoping you could provide a little more color around just what is this kind of translates into for CVR energy.

Speaker Change: Yes happy to cover that yeah, we are expecting a little bit of seasonality to hit as we go from Q4 to Q1, it's something that we've seen with other companies as they approach this $50 million revenue Mark and something that we did experience as we look back to Q1 of 2024.

What's what's the Northstar account look like how many implants are there what could utilization trend too and then maybe how does that trend over a longer period of time from a growth perspective.

Speaker Change: Sure. Thanks Frank.

Speaker Change: To address that so we think at this stage that the accounts at a number of characteristics exist in the accounts that had most deeply adopted this therapy the.

Speaker Change: Seasonality to be impacting the business.

Speaker Change: The first is that its led not just by our clinical champion that often brings us initially but that clinical champion has an administrative partner.

Speaker Change: Thank you.

Speaker Change: <unk> Air cover from a financial standpoint for this program in the center that's really important.

Speaker Change: Thank you.

Speaker Change: Our next question is from Frank <unk> with Lake Street Capital markets. Please proceed with your question.

Speaker Change: Second it involves not one but multiple heart failure specialists in the center, who are effectively the prescribers of the therapy and theyre getting referrals from not one or two but multiple community based physicians, whether their heart failure specialists, atp's electrophysiologist et cetera general cards right.

Frank: Great. Thanks for taking the questions I was kind of a round point to that you've talked about kind of priorities for 2025 about sustainable barrels stem programs I heard the comments around large heart very volumes appetite to adopt new novel devices, but I was hoping you could provide a little more color around just what is this kind of translates into for CVR energy.

Speaker Change: Importantly, those prescribers are working with multiple implants, so surgical partners that implant the device and what we found is that when we can create that sort of redundancy and ecosystem that looks like that we see sustained predictable continued utilization of the therapy and that's really what we're driving for here that's kind of.

Frank: What's what's the Northstar account look like how many implants are there what could utilization trend too and then maybe how does that trend over a longer period of time from a growth perspective.

Speaker Change: Sure. Thanks, Frank happy to address that so we think at this stage that the accounts at a number of characteristics exist in the accounts that had most deeply adopted this therapy. The first is that it's led not just by our clinical champion that often brings us initially but that clinical champion has an administrative.

Speaker Change: The North Star and so those are some of the elements I mentioned earlier that we've now built into the comp plan for the coming year will pay effectively not all implants are created equal we will pay more.

Speaker Change: Significantly more in some cases for an implant that comes from a center that has those components in place. So again, we're trying to drive behavior within our team to build more and more of these centers to look and feel like that.

Speaker Change: Partner it sort of flies air cover from a financial standpoint for this program in the center that's really important.

Speaker Change: Second it involves not one but multiple heart failure specialists in the center, who are effectively the prescribers of the therapy and theyre getting referrals from not one or two but multiple community based physicians, whether their heart failure specialists atp's electrophysiologist, except for general cards, right and <unk>.

Speaker Change: Okay. That's helpful and then thinking about the three to 400 target accounts you you've spoken about in previous calls where do you stand in that group of three to 400 target accounts for these barrels stem programs really could exist.

Speaker Change: Yes.

Speaker Change: Hi, Frank happy to take that one so as you know we have the 223 active implanting centers at the end of the year at this point in time, we're still not disclosing the breakdown of the centers that we're focused on targeting.

Speaker Change: It could be something that we consider disclosing at some point down the road again. This strategy is something that we just rolled out at the beginning of October and so it's going to take some time to start to see more and more of these centers get activated because it does take time to get through value assessment and get on contract with those centers.

Speaker Change: Star and so those are some of the elements I mentioned earlier that we've now built into the comp plan for the coming year will pay effectively not all implants are created equal we will pay more.

Speaker Change: But I could add that we have a long way to go lots of runway there and we are 223 or certainly not all from tier one or two.

So we've got lots of room, we think to further optimize our account mix.

Speaker Change: Perfect. Thanks for taking the questions.

Speaker Change: Okay. That's helpful and then thinking about the $3 to 400 target accounts you you've spoken about in previous calls where do you stand in that group of three to 400 target accounts for these barrels 10 programs really could exist.

Speaker Change: Thank you. Our next question is from Chase Knickerbocker with Craig Hallum Capital Group. Please proceed with your question.

Chase Knickerbocker: Good afternoon, guys, just maybe following up on Frank there for a second.

Speaker Change: Yeah.

Speaker Change: Example of that Northstar count that.

Speaker Change: Hi, Frank happy to take that one so as you know we have the 223 active implanting centers at the end of the year.

Chase Knickerbocker: That you gave.

Chase Knickerbocker: In your most developed accounts at this point that looked like that you know call. It top decile, what the units per quarter look like.

Speaker Change: At this point in time, we're still not disclosing the breakdown of the centers that we're focused on targeting but could be something that we consider disclosing at some point down. The road again. This strategy is something that we just rolled out at the beginning of October and so it's going to take some time to start to see more and more of these centers get activated.

Chase Knickerbocker: Yeah Chase, we haven't broken it down at the account level at this point in time, but we are seeing those centers get well above our goal of treating at least one patient a month in some cases, we know theres dozens and potentially even hundreds of these patients available at these top tier centers. So it's on us to really go draw.

Speaker Change: It does take time to get through value assessment and get on contract with those centers.

Speaker Change: But I couldn't add that we have a long way to go lots of runway there and we are 223 or certainly not all from tier one or two.

Chase Knickerbocker: <unk> utilization and drive deeper adoption at each one of these centers, but we're not breaking it down by center at this point in time.

Speaker Change: So we've got lots of room, we think to further optimize our account mix.

Chase Knickerbocker: So chase we we took this new relatively new definition of tier 1234, and applied it retroactively against the accounts that we've developed over the last three years and we were pleased to see that it in fact that tier one accounts did in fact outperformed tier two three and four.

Speaker Change: Perfect. Thanks for taking the questions.

Speaker Change: Thank you. Our next question is from Chase Knickerbocker with Craig Hallum Capital Group. Please proceed with your question.

Speaker Change: Good afternoon, guys, just maybe following up on Frank's there for a second.

Chase Knickerbocker: In that exact order so it sort of validates to some degree what we think these signals of.

Speaker Change: <unk> of that Northstar account.

Speaker Change: That you gave.

Chase Knickerbocker: What good looks like.

Speaker Change: In your most developed accounts at this point that look like that you know call. It top decile, what the units per quarter looked like.

Chase Knickerbocker: Centres in fact do outperform their peers, where we think the reasons. We described so that was encouraging.

Chase Knickerbocker: Great.

Speaker Change: Yeah Chase, we haven't broken it down at the account level at this point in time, but we are seeing those centers get well above our goal of treating at least one patient a month in some cases, we know theres dozens and potentially even hundreds of these patients available at these top tier centers. So it's on us to really go deep.

Chase Knickerbocker: Maybe just on the reimbursement front.

Speaker Change: Is there any advocacy that you guys can do kind of in front of us.

Chase Knickerbocker: Kind of 2026 decisions in.

Chase Knickerbocker: On the interim side, let me, let me get the proposed op EPS in July is there any kind of outreach that your market access team can be doing at this point or anything we should kind of be tracking.

Speaker Change: Drive utilization and drive deeper adoption at each one of these centers, but we're not breaking it down by center at this point in time.

Chase Knickerbocker: Yes, that's a great question. The answer is yes, absolutely and our team is already engaged along with the other now for members of the coalition.

Speaker Change: Could you add though chase we we took this new relatively new definition of tier 1234, and applied it retroactively against the accounts that we developed over the last three years and we were pleased to see that in fact, the tier one accounts did in fact outperformed tier two three and four in that.

Chase Knickerbocker: Work is well underway and so we are meeting with folks at CMS meeting with the team.

Chase Knickerbocker: And additional statistical and consulting resources to help CMS really understand that the only way to solve this issue on a permanent basis is to create that level six coke. So we're pleased that the interaction. So far we're pleased that they've not been disrupted by the administrative changes in D. C. Over the last couple of weeks and we're increasingly confident that we will ultimate.

Speaker Change: Exact order so it sort of validates to some degree what we think these signals.

Speaker Change: What good looks like.

Speaker Change: <unk> centers in fact do outperform their peers for we think the reasons. We described so that was encouraging.

If not this year then soon achieve that final permanent level six total.

Speaker Change: Great.

Speaker Change: Maybe just on the reimbursement front.

Chase Knickerbocker: And then as we think about the cat one code.

Speaker Change: Is there any advocacy that you guys can do kind of in front of it.

Chase Knickerbocker: Effective Jan 126.

Speaker Change: 2026 decisions in.

Chase Knickerbocker: Is there any kind of moving pieces, we should be thinking about around kind of the RV used that you're assigned as far as how it could kind of indicate.

Speaker Change: On the interim side, let me, let me get the proposed O P. P. S. In July is there any kind of outreach that your market access team can be doing at this point or anything we should kind of be tracking.

Chase Knickerbocker: An uptick in potential demand if things kind of skew positive anything that you can kind of give there as far as how youre thinking about kind of DRP use it could be a sign you procedural code.

Speaker Change: Yeah. That's a great question. The answer is yes, absolutely and our team is already engaged along with the other now for members of the coalition.

Chase Knickerbocker: Yes, so we are not.

Chase Knickerbocker: By definition, we are not allowed to influence that process in any way. The survey is now complete as we understand it our first visibility to the actual argues that will be assigned will come in July.

Speaker Change: Work is well underway and so we are meeting with folks at CMS meeting with the team.

Speaker Change: Bringing in additional statistical and consulting resources to help CMS really understand that the only way to solve this issue on a permanent basis is to create that level six coke. So we're pleased that the interaction. So far we're pleased that they've not been disrupted by the administrative changes in D. C. Over the last couple of weeks and we're increasingly confident that we will.

Chase Knickerbocker: With the proposed rule and so we believe.

Chase Knickerbocker: That that those our views will fall in the range that are currently being <unk>.

Chase Knickerbocker: Negotiated with the payers today, roughly between 508 hundred or $850 per procedure, because they crosswalk it often to a carotid endarterectomy. So theres no reason to believe that that same outcome. We won't see that same outcome from the survey itself, So where we're interested in what we'll see in July.

Speaker Change: Lee if not this year then soon achieve that final permanent level six total.

Speaker Change: And then as we think about the cat one code.

Speaker Change: Effective Jan 126.

Chase Knickerbocker: But we don't believe there's a ton of risk there at least as of today.

Speaker Change: Is there any kind of moving pieces, we should be thinking about around kind of the RV use that youre assigned as far as how it could kind of indicate you know.

Chase Knickerbocker: Great. Thanks, guys.

Speaker Change: An uptick in potential demand if things kind of skew positive anything that you can kind of give there as far as how youre thinking about kind of DRP use it could be a sign you procedural code.

Speaker Change: Thank you there are no further questions at this time I would like to hand, the floor back over to Kevin Hart for any closing comments.

Speaker Change: Thank you operator, and thanks again to everyone for joining us for our fourth quarter and full year earnings call. We appreciate your ongoing support and we look forward to updating you on our progress at our next call. Thank you.

Speaker Change: Yeah. So we are not buy.

By definition, we are not allowed to influence that process in any way. The survey is now complete as we understand it our first visibility to the actual RV use it will be assigned will come in July.

Speaker Change: This concludes today's conference.

Speaker Change: With the proposed rule and so we believe.

You may disconnect your lines at this time, thank you for your participation.

Speaker Change: That that those our views will fall in the range that are currently being.

Speaker Change: Negotiated with the payers today, roughly between 508 hundred or $850 per procedure, because they crosswalk it often to a carotid endarterectomy. So theres no reason to believe that that same outcome. We won't see that same outcome from the survey itself. So we're up we're interested in what we'll see in July.

Speaker Change: But we don't believe there's a ton of risk there at least as of today.

Speaker Change: Great. Thanks, guys.

Speaker Change: Thank you there are no further questions at this time I would like to hand, the floor back over to Kevin for any closing comments.

Kevin: Thank you operator, and thanks again to everyone for joining us for our fourth quarter and full year earnings call. We appreciate your ongoing support and we look forward to updating you on our progress at our next call. Thank you.

Speaker Change: This concludes today's conference.

Speaker Change: You may disconnect your lines at this time, thank you for your participation.

Q4 2024 CVRx Inc Earnings Call

Request a DemoDemo

CVRX

CVRx

Earnings