CVRX - NASDAQ

Nadim Yared - President, Chief Executive Officer Jared Oasheim - Chief Financial Officer Mike Vallie - Westwicke, ICR Company

Good day and thank you for standing by. Welcome to the CVRx Second Quarter 2022 Earnings Conference Call. [Operator Instructions]. I would now like to hand the conference over to your speaker, Mike Vallie. You may begin.

Good afternoon. Thank you for joining us today for CVRx’s second quarter 2022 earnings conference call. Joining me on today’s call, are the company’s President and Chief Executive Officer, Nadim Yared; and its Chief Financial Officer, Jared Oasheim. The remarks today will contain forward-looking statements including statements about financial guidance. The statements are based on plans and expectations as of today which may change over time. In addition, actual results could differ materially due to a number of risks and uncertainties including those identified in the earnings release issued prior to this call and in the Company's SEC filings, including the upcoming Form 10-K that will be filed with the SEC. I would now like to turn the call over the CVRx's President and Chief Executive Officer, Nadim Yared.

Thank you, Mike. And thanks to everyone for joining us today. I’ll begin today’s call by providing an overview of our second quarter performance, followed by an operational update, a review of our financial results by our CFO, Jared Oasheim, and then I will conclude with our thoughts for the rest of 2022 before turning to questions and answers. Starting with the review of the second quarter. Our total revenue was $5.0 million, an increase of 61% over the second quarter of 2021. These results were driven by the continued execution of our growth strategy, both in the United States and internationally. In the U.S., our Heart Failure business generated $3.8 million, an increase of approximately 89% over the second quarter of 2021, resulting from a record number of revenue units sold in the quarter. This growth was due to the expansion into new implanting centers, and existing implanting centers continuing to increase their average quarterly volume. Throughout 2022, we have seen the positive impact of our commercial expansion strategy, supported by an increase in marketing and awareness campaigns. Additionally, we have continued to see some encouraging trends stemming from commercial investments made in Europe during the fourth quarter of 2021. I now want to give you an update on the operational development during the second quarter to support greater adoption and use of Barostim. As a reminder, our focus areas are: One, the continued expansion of commercial infrastructure; Two, innovation of our product portfolio; and three, the expansion of the clinical body of evidence. Let’s begin with the continued expansion of our commercial infrastructure, specifically our U.S. direct sales organization. During the quarter, we added three new territories, bringing the total to 20, and we expect to add an average of three new territories per quarter finishing the year with about 26 territories. The caliber of the sales organization and their ability to drive the adoption of Barostim continues to exceed our expectations. We are making positive headway in select geographies, where our direct-to-consumer pilot program to support patient education is being conducted with our new branding campaign. We will continue to look for ways to optimize the program as we expand further. Additionally, we continued our pilot to advance patient education in select institutions aimed at patients who are already speaking with physicians about our Barostim device. The first phase of this pilot has been successful, and we have started expanding the program to additional institutions. With both our direct-to-consumer marketing program and expanded patient education program gaining traction, we are happy with the progress made to-date. For the remainder of 2022, we will continue to invest in the rollout, optimization and expansion, including the continued hiring of in-house expertise to support the successful growth of these programs. Our second area of focus is the innovation of our product portfolio. In the first half of the year, we received clearance on three pre-market approval supplements related to our Barostim platform. The first was for Barostim MRI Conditional Labeling, which allows all Heart Failure patients, who have received or will receive a Barostim device to undergo an MRI exam under certain conditions. The second was for our new implantable pulse generator, which is smaller in size than prior generation and has 20% longer battery life on average. And the third was for our new programmer, which is a tablet form factor with an even simpler programming software. We are now in the process of launching the new platform. Our third and final focus is the expansion of our clinical body of evidence. The BeAT-HF clinical trial is designed to demonstrate the mortality and morbidity benefit of Barostim in the Heart Failure patient population with Reduced Ejection Fraction. The time line for BeAT-HF remains on track with all the necessary events expected to accrue by the end of this year. Once we have collected all the required events, we will provide a more detailed review of the un-blinding process, which we continue to believe will occur during the first half of 2023. In addition, we remain on track with BATwire, our Ultrasound Guided Implant Toolkit. We continue to expect the trial to be fully enrolled in 2023 and expect FDA approval by the end of 2024.Despite some difficult challenges from COVID, inflation and supply chain disruption in the first half of 2022, we are immensely happy with what we were able to accomplish. The performance seen in the second quarter is encouraging as it validates the growing demand for Barostim. Looking ahead, we remain committed to executing our commercial plan and are on track for continued growth for the balance of 2022. I’ll now turn the call over to Jared to review our financials. Jared.

Thanks, Nadim. Total revenue generated in the second quarter was $5.0 million, which is an increase of $1.9 million or 61%, when compared to the same period last year. Revenue generated in the U.S. was $3.9 million in the second quarter, which is an increase of 87% over the same period last year. Heart Failure revenue in the U.S. totaled $3.8 million in the second quarter on a total of 128 revenue units as compared to $2 million in the same period last year on 67 revenue units. The increase was primarily driven by continued growth as a result of the expansion into new sales territories, new accounts and increased physician and patient awareness of Barostim. At the end of the second quarter, we had a total of 71, active implanting centers as compared to 31 at the end of Q2, 2021 and 56 at the end of Q1, 2022. At the end of the second quarter, we had a total of 20 sales territories in the U.S. compared to eight at the end of Q2, 2021 and 17 at the end of Q1, 2022. Revenue generated in Europe was $1.1 million in the second quarter, which is an increase of 7% when compared to the same period last year. Total revenue units in Europe increased from 47% in Q2, 2021 to 52% in Q2, 2022. The increase in revenue was primarily due to the lessening impact of the COVID-19 pandemic in Germany and our continued investments in the European commercial organization, partially offset by an unfavorable currency impact on revenue. Gross profit was $3.8 million for the second quarter, an increase of $1.6 million, when compared to the same period last year. Gross margin increased to 76% for the second quarter compared to 71% for the same period last year. Gross margin was higher due to a decrease in the cost per unit and an increase in the average selling price. This was partially offset by a larger percentage of our revenue units coming from full systems versus battery replacements. Research and development expenses were $2.4 million for the second quarter, which is an increase of 4% when compared to the same period last year. This change was primarily driven by increased headcount. SG&A expenses were $12.5 million for the second quarter, which is an increase of 122% when compared to the same period last year. This was primarily driven by increases in compensation expense due to increased headcount, stock compensation, public company costs, travel and an increase in marketing and advertising expenses related to the investments associated with the commercialization of Barostim in the US. Net loss was $11.1 million or $0.54 per share for the second quarter as compared to a net loss of $17.7 million or $48.48 per share for the same period last year. Net loss per share was based on approximately 20.5 million weighted average shares outstanding for the second quarter and approximately 366,000 weighted average shares outstanding for the second quarter of 2021. At the end of the second quarter, cash and cash equivalents were $121.3 million. Net cash used in operating and investing activities was $10.1 million for the second quarter compared to $6.8 million for the same period last year. We continue to prudently monitor our cash usage in support of our growth initiatives as we progress toward profitability. Now turning to guidance. For the full year of 2022, we now expect total revenue between $20.5 million and $23.0 million, gross margin between 75% and 76% and operating expenses between $58 million and $61 million. For the third quarter of 2022, we expect to report total revenue between $5.5 million and $6.0 million. I would now like to turn the call back over to Nadim.

Thanks, Jared. We are enthusiastic about the momentum we have developed in the second quarter and throughout the first half of 2022. And we are very well positioned to leverage that momentum and accelerate the adoption of Barostim throughout the rest of 2020. Before I open the line for questions, I wanted to thank everyone at CVRx for the tremendous work they have done to get us where we are today. We have only made it to this point because of the dedication and hard work of our team. Now, I would like to open the line for questions. Operator.

Thank you. [Operator Instructions]. Our first question comes from the line of Robbie Marcus with J.P. Morgan. Your line is open.

This is, Alan on for Robbie. Congrats on the great quarter. Just to touch on the macro-environment in the U.S. On the first quarter, you had highlighted that staffing shortages had continued to be a challenge for your volume growth. So, I guess, like how have those trends continue to develop into the second quarter, and what does your guidance assume for the impact in the back half of the year?

Alan, thank you for joining us. Yes, so if you recall the first quarter had tale of two cities. The beginning of the quarter was difficult; we had some remnants of the COVID impact in the United States. The second half of the quarter was actually very solid. And we commented at the time about the staffing shortages and the labor shortages being one of the obstacles that we were trying to overcome with our [inaudible] program to shift some of the education burden of patients wherever it’s possible, ethical and legal for us to do, we are wanting and willing, and able to do this type of education. And that has translated into reducing the negative impact of the labor shortage at our clients, and that’s why we’re seeing the results we are seeing. As it relates to the guidance for next quarter, and maybe Jared, I’ll turn to you.

Yeah, hi Alan, this is Jared. So, as for the guidance for Q3 and for the rest of the year, we are still expecting to see a bit of a headwind from that hospital staffing shortage related to new center activation. And so even though we were able to see 15 net new centers be added in the second quarter, we are still expecting the numbers to be in the high single digits for each quarter, meaning seven, eight, or nine in Q3, seven, eight or nine added in Q4 for the rest of this year.

Got it. And then, you know what kind of benefit have you seen from the new product approvals, the new MRI conditional approval you got earlier in the year, and how should we think about the benefit from those approvals as well, the new programmer on the back half? Thanks guys.

Yeah, thank you. Good question. If you recall from our previous communication on this topic, we expected the impact of these new programs to be minimum. We did not expect that to generate additional revenue, but rather be a source of a better customer and better patient satisfaction with our product and technology. Particularly the conditional MRI compatibility, you know without it, when patients had to undergo an MRI, they could not. So, if a patient has, for example a stroke that is not related to our product, it limited the ability of physicians to order or prescribe an MRI to diagnose the patient. With this new labeling we have right now, they can do an MRI under certain conditions that are in our labeling, and we’re very excited about this. So it’s more about increasing patient satisfaction, but also physician and nurse satisfaction with our product technology, and the same can be said about the size of the device, about the battery longevity down the road and about the ease of use and the smaller form factor and the portable form factor of the new programmer as well. So in summary here, we don’t expect those to generate more revenues, but rather just move us a notch forward here in terms of satisfaction.

Thank you. Please stand by for our next question. Our next question comes from the line of Margaret Kaczor with William Blair. Your line is open.

Hey! Good afternoon guys. Thanks for taking the questions. I wanted to follow up a little bit on some of the new commercial activities that you guys have launched and maybe just to start out with, the strategic account managers and their impact on larger national accounts. So one, have you seen an impact at this point? And then two, you know when should we hear more about this, and is it going to be a series of updates or you’ll just update us over time and we’ll see them in the new centered accounts?

Yeah, hello Margaret! Glad to hear your voice. Listen, in regards to the addition of the Strategic Account Director, Kevin Denton, the goal for us is to ensure that those multi-site institutions, IDNs or others, that span over multiple geographies, multiple territories, but yet have one single contract, that we have a single person following on the contracting process, and that has started paying us. Now, what we do not report are the centers that are under an active contract for that exact reason. You know if Kevin and his team, if they sign up an agreement with a large group that has 100 sites, practically we could sell at 100 sites, but really, no, because we need to develop this program at every single site with the champion and the clinical team around this program. And therefore we don’t report the sites that have in the active agreement with us. We report a site that has an active implanting experience, so they have done at least one implant in the previous 12 month. So bottom line, this is a well-needed activity. You’ve seen this also in play with other similar companies at our stage, where those contracting at these high levels are imported, and we’re starting to see the impact and it still requires a lot of work with the clinical team to develop a program. But at least that’s part of the contracting when it’s signed at a high level. At the umbrella level, it simplifies a lot of the prospect.

Okay, great! And then just to follow up, just like my other two colleagues had on the new accounts. Obviously, it was great to see a larger new center number. It does sound like according to Jared, if you target kind of that high single-digit increase in new centers through the rest of the year, it’s pretty similar maybe to what we saw before going into year end. So correct me if I’m wrong about that, but ultimately to the extent that these do ramp and do reach productivity a little bit faster relative to our prior expectations, it seems like that should be a good thing. So any details around that would be useful, you know especially as it relates over the next 12 to 18 months? Thanks guys.

Yes Margaret, the only thing I’ll add to it is, like we said before, we’re going to continue to be opportunistic. If the sites are coming onboard and starting to treat patients at a faster pace or the utilization on a monthly basis is going up, and we need staff to support the implants or be able to go out and open some of these new centers that could be associated with national contracts, we’ll make those investments. The goal here is to grow at a fast pace to help as many patients as quickly as possible. But at the same point, we don’t want to put resources in places that aren’t going to be helping to drive top line and be able to help patients early on.

Fair enough. Thanks guys.

Thank you. [Operator Instructions] Please stand by for our next question. Our next question comes from the line of Alex Nowak with Craig-Hallum. Your line is open.

Great! Good afternoon everyone. I was just hoping to expand upon Matt’s question. Looking at the pipeline of sites out there, could you maybe frame up how many accounts or sites of sales organization is that you’ll be speaking with or currently train today? Just how many are down the path of looking at Barostim, let’s say seriously and just where can those implanting account numbers or site numbers, where could those trend throughout the remainder of the year?

Yes Alex, hey! Great to see you here. Listen, we have not disclosed this number. Again, it’s the complexity of disclosing a number that could misguide because of those IDN and the large accounts groups. So for example, let’s say hypothetically speaking, if we sign an agreement with tenants, do we count in all of their hospitals they have? How about the clinics? How about the standard centers or the OBLs that they own? You know it is so complicated, that’s why we don’t venture into disclosing that numbers. I don’t know how else I can help you with this one. The...

And maybe I’ll just chime in here too Alex. One of our standard responses for this is, we’re always at least a quarter ahead for contracts signed, right. And so we see the pipeline of what’s coming through contracts that are signed, coalitions that are being worked from an implanting perspective, so that they can start identifying patients to actually start treating those patients. And so we have some visibility into this, but it’s been varying between centers as far as how quickly they move from a contract signed to treating that first patient. And so you know we wish we had more informative data that we could give to the – to all of you folks at this point related to those contracts signed, but there’s just too much variability as to the timeline from contract signed to becoming an active implanting center.

Yeah, so understood, that makes sense. And going back to the cadence discussion that we had on the Q1 call, but looking at Q2 here, would you say there was a big bifurcation versus beginning of the quarter versus end of the quarter for a number of Barostim implants per site, or would you say things kind of trended generally stable throughout the quarter for procedure volumes?

Yes, thanks for bringing that up, Alex. We – Nadim mentioned that earlier, you know Q1, it was almost silence in the month of January and then starting to see some recovery in February and really a big March for procedures to be able to hit the numbers that we did in Q1. As we moved into Q2, it really has moved into a stable setting. We haven’t really seen an impact from COVID or hospital staffing shortages to actually perform procedures, so month-over-month, just seeing steady growth as we marched all the way through Q2.

Okay, understood. And then just lastly, maybe just an update on reimbursement. Speak to the process, is that an acute upgraded to a category one CPT code, the potential to make the CPT pass through payment permanent? And then just any feedback on reimbursement you’re seeing from the field?

Absolutely! I can address this, Alex. So in regard to the category one code, so the CPT 1 coding, this process usually takes three years from the moment a physician society takes ownership and starts on the process, and of course we are in discussions with multiple physician societies, and here we have not yet disclosed if we selected one of them to champion the process. The process is public, so as soon as this will go on the docket, we’ll disclose it to the market and to all of you and we’ll talk about what it means and the next step from it. But don’t expect from – you know I do not expect from my perspective, a category one code before 2025. And it might be shocking to you, but even if they started today, the earliest they will get to it will be late 2024, early 2025. Now is this hurting us right now? I would say, yes of course, because it gives the perception that the therapy is experimental, that’s what a category three means. But are the hospitals getting paid today? Yes. Are physicians getting paid today? In general, yes. We are able to get them the payment they deserve by of course walking the procedure to similar procedures, and we have a very solid reimbursement team in headquarter and also in the field to support those endeavors and the billing processes, and after the billing when they get the payments, if there is the need here to negotiate with payers and so forth, we are doing this. So that’s the situation with category one code. In regards to the transitional pass through, so this is the hospital payment system. Currently we have a transitional pass through that removes the price of the device from the existing code, which pays as the national average around $30,000 this year and $29,900, also almost $30,000 next year. And substitute instead of it, the price of our device, which is as you know $35,000. So that is giving hospitals a decent reimbursement. That is that seems to be economically viable for hospitals to continue adopting Barostim for Medicare patients. For private patients, the payment is negotiated usually between the hospital and the payer, and in general it is known that private payers do reimburse hospitals a little bit more than what Medicare does. So from that perspective we believe also that private payers, when they are authorized, the payment to the hospital is also economically viable. So the question for the TPT is about the duration. Right now, our TPT – it’s a known fact actually. Our TPT expires in the end of 2023. So we still have a year and a half to go with this process. We started down the path of asking CMS to consider creation of a higher paying code for therapies like ours. There are a couple of other companies that have also joined this effort. In this most recent public filing by CMS, which is their proposal for the outpatient payment systems, they mentioned our request and that they still don’t support it, but they are opening this for public comment. It’s a huge first step. Of course, we will comment on it, and we’ll be waiting, I would say eagerly for the final decision from CMS, which will be late November, early December and we’ll see if we have a permanent code or not. Nevertheless, we still have a year with the TPT right now. In an absolute worst-case scenario for us, where we do not receive a new code, we will have to revert back to selling our device at around $25,000 and that’s why you would hear Jared and sometimes me repeating to you, in your estimate, in your forecast for the future for our therapy, put in a year an ASP of $25,000, $26,000 that will still make it economically viable to hospitals even without a TPT as a worst case scenario. In a good case scenario, we get a new code and we maintain the pricing and our ASP stayed in the $28,000, $29,000. Jared, I don’t know if there’s anything to add in here?

Alex, did that answer your question in here about – it’s a complicated topic. Sorry about going long.

Yes. No, that was perfect. I really appreciate all of the info here. Thanks.

Fantastic!

Thank you. Please stand by for our next question. Our next question comes from the line of William Plovanic with Canaccord. Your line is open.

Great! Good evening, thanks. Just the main question I have is, you know we saw the acceleration of new account additions in the quarter, and you’re doing that with your current staff, and you know you’ve been pretty methodical on the build-out thus far. I was wondering, do you plan on either (a) accelerating new account onboarding with the existing commercial org or expanding the commercial org faster? Kind of like it seems like you’re getting to that. As you know I always ask the question, is it reproducible, repeatable, and it seems like you’re starting to get to that point, at least with account onboarding? Thanks.

Yeah, hey! Thank you for joining us. So yes, is this a situation of rinse and repeat and it seems to be so. It seems to be repeatable, it seems to be scalable and are we planning to accelerate? No. Are we being opportunistic in some situations? Yes. The model seems to hold true and you know our plan is to continue adding three territories every quarter, but we’ll be opportunistic when we see a chance to go.

Okay. And then I don’t know if this was covered or not. Just – did you provide if we’re going to see – when we’re going to see the M&M data?

Yes, this was not covered in the Q&A. We still are expecting to accrue all of the events that we need, and as a reminder, this 320 mortality morbidity events before the end of this year, this current year 2022. And the unblinding will happen very likely in the first half and possibly end of first quarter of 2023. Now, as we get closer to that date, the cone of uncertainty regarding the date is narrowing. It comes a moment when we will feel comfortable about the schedule of the unwinding, and we will do a public communication about the exact sequence of the unblinding. Now this trial, whenever you’re talking about mortality and morbidity, it’s a complicated matter. Why? If a patient is hospitalized and it’s a long hospitalization. So think about it, medical management patients who did not receive a Barostim is admitted for a heart failure event, and that event takes a month to resume. You have to wait that full month. Even the date of occurrence happened, you have to wait until the patient is discharged and all of the data has been collected, and all of the data has been adjudicated in a blinded fashion by our primary event committee before the data becomes data, and that is what creates some of the uncertainty Bill, between the time when we will get the event, until the time that we know, all right, this is the data, let’s look at it. And as I mentioned earlier, towards possibly before the end of the year I hope, we will be in a position to communicate the exact timeline of the unblinding process.

Great! Thanks for taking my questions.

Thank you.

Thank you. That concludes our question-and-answer session for today. I would now like to turn the call back over to Nadim Yared for closing remarks.

Alright, thank you operator, and thanks again everyone for joining us for our second quarter earnings call. We – as you can imagine, we do appreciate your ongoing support and we look forward to updating you on our progress on our next update. Have a great evening!