Ladies and gentlemen, thank you for standing by and welcome to the CVRx Q4, 2021 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers presentation, there will be a question-and-answer session. [Operator Instructions]. I would now like to turn the conference over to your speaker for today, Mike Vallie. You may begin.

Good afternoon and thank you for joining us today for CVRx's fourth quarter and full-year 2021 earnings conference call. Joining me on today's call are the Company's President and Chief Executive Officer, Nadim Yared and it's 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 thank you everyone for joining us this afternoon. I'll begin by providing an overview of our fourth quarter and full-year performance followed by an operational update and our CFO, Jared Oasheim, will then review our financial results and I will conclude with our thoughts for 2022 before turning to Q&A s. We are very proud of everything that our team accomplished in 2021 taking into consideration the material headwinds caused by COVID-19 in the U.S. and in Germany. In 2021, we more than doubled our worldwide revenue, delivering full-year growth of 115% driven primarily by our U.S. Heart Failure business that grew more than 750%. We also made progress towards our strategic initiatives including the first patient implanted with the help of our new ultrasound guided implant toolkit. In the fourth quarter, total revenue was $3.7 million which fell short of our expectations primarily due to COVID related headwinds in Europe. Despite this impact, we saw an increase of approximately 75% over the fourth quarter of 2020. This significant year-over-year growth at the quarter highlights the resilience seen in our U.S. Heart Failure Business. Turning now to an operational update. First, I wanted to give you a quick update on hiring. We added over 50 new employees in 2021 bringing the total [Indiscernible] to over 100 employees worldwide. Being able to more than double the size of the organization by bringing in top talent in a tough hiring environment is a testament to the excitement in the industry for Barostim and the opportunity that lies ahead. Of the new hires, two are for senior management including our Chief Marketing Officer and our European VP of Sales and Marketing. As part of that hiring, we continued the expansion of our commercial infrastructure. As planned, we added three…

Thanks, Nadim. Total revenue generated in the fourth quarter was $3.7 million, which is an increase of $1.6 million, or 75% when compared to the same period last year. Revenue generated in the U.S. was $2.9 million in the current quarter, which is an increase of 244% over the same period last year. Heart failure revenue in the U.S. totaled $2.7 million in the current quarter on a total of 95 revenue units as compared to $607,000 in the fourth quarter of last year on 21 revenue units. The increase was primarily driven by continued growth in the U.S. heart failure business, as a result of the expansion into new sales territories, new accounts and increased physician and patient awareness of Barostim. At the end of the current quarter, we had a total of 46 active implanting centers compared to 38 on September 30th, 2021 and 11 on December 31, 2020. At the end of the current quarter, we had a total of 14 sales territories in the U.S. compared to 11 on September 30, 2021 and 6 on December 31, 2020. Revenue generated in Europe was $800,000 in the current quarter which is a decrease of 36% when compared to the same period last year. Total revenue units in Europe decreased from 55 in Q4, 2020 to 39 in the current quarter. The decrease is due to the COVID related headwinds in Germany in December 2021. The number of sales territories in Europe remained consistent at six during the current quarter. Gross profit was $2.7 million for the current quarter which is an increase of $1 million over the same period last year. Gross margin decreased to 73% for the current quarter compared to 78% for the same period last year. Gross margin in the current quarter was lower…

Thanks, Jared. Before opening the line for questions, I would like to discuss our key areas of focus for 2022 as we seek to drive the increased adoption and utilization of Barostim. First, the continued expansion of our commercial infrastructure, specially our direct sales force in the United States, remains a top priority. We expect to continue hiring top talent throughout the year in our targeting a total of approximately 26 U.S. territories by year-end, or on average, adding three new territories per quarter. Outside of the U.S., we have added additional talent to our direct sales organization in Germany to help expand our sales efforts in Europe, and we continue to expect to add incremental headcount in 2022 to support our commercial strategy in that region. In 2022, we will continue to invest in marketing efforts focused on both physician and patient education. This includes the continuation of the direct-to-consumer pilot program, initiated in 2021. The pilot is primarily a series of digital marketing campaigns designed to educate potential patients and help them manage through their journey to therapy. To support these efforts, we are investing in the launch of our new patient-focused branding campaign which will be rolled out during the first quarter of this year. Currently, the programs are only running in a select number of markets but we plan to prudently expand to additional geographies in the U.S. and experiment with [Indiscernible] additional marketing channels throughout the year. We look forward to updating you on the progress on these initiatives on future earnings calls. As mentioned earlier, we also created an internal prior authorization team. In 2021, we built the small in-house team working directly with physician offices to help patients seek prior authorization for our procedure. We believe this to be a critical function to…

Thank you. [Operator Instructions]. Please stand by while we compile the Q&A roster. Our first question comes from the line of Robbie Marcus with JPMorgan. Your line is open.

Great. Thanks for taking the questions. Nadim, maybe we could start -- how do you try and how do you think about the barriers here to Barostim? What's the push back you get when you go to hospitals? Is it all COVID related, and difficulty getting in, and educating and establishing these centers? Is there some push back to the procedure? Would just love to get your thoughts on how you think about the commercial rollout?

Yeah, sure. First, good evening Robbie and again, thank you for inviting CVRx to present at the JPMorgan conference. That was a great experience for us, we look forward hopefully to be invited in future years and hopefully to meet face-to-face. Listen, the obstacles, if you want to call on this way or the objections that we may face in any new account are very similar to any new therapy. The first and foremost, administration is always wary about the reimbursement and they would like to see a couple of cases reimbursed and paid for. And once they see that, they feel more comfortable. So what we often see happening, centers signing up first for a pilot phase, a few units and then expanding into commercial use, making it more of a routine basis. The second is training of physicians, training of nurses on how to identify the appropriate patients who are eligible to receiving our therapy. And then how to do the implant, which in our case is very simple, the [Indiscernible] is extremely simple. And after the implant, is the follow-up in the management of the patients. What we are seeing though, right now, is possibly a unique situation where we have the confluence of the COVID-19 pandemic killing us sporadically from time-to-time in a geography to geography combined, or maybe causing hospital staffing shortage. And in our experience, what we're seeing, this is possibly impacting us proportionately more than established product lines. The reason for that is the -- any chip, given the choice, and if they have limited time to select few pro -- fewer procedures they can do, given the choice, they will revert back to their area of comfort, their zone of comfort with established procedures. That's why newer procedures end up paying a little of the price here being pushed away, and that's what we're seeing. And why do I notice and how do I notice? We've signed up more accounts than we've activated [Indiscernible] Q4. And when you dig down deep about what is going on, that's exactly what is going on. The staff is facing a shortage of 1 or 2 or having a tight schedule, revert back to existing therapies that they know they're predictable, they know exactly what to expect rather than embarking on a new program. So I don't know, Robbie here, if I answered all of your question in here on what you were trying to get to.

Yeah. That definitely does. And then maybe just a quick follow-up. Much smaller part of the story, but somewhat of a hit to 2022 versus prior expectations was Europe. Maybe just update us on -- month ago you gave us your plan to stabilize and improve Europe, but maybe just give us a progress report of how it's going so far. Thanks.

Thanks for asking me this question. So what is common between Europe, particularly Germany and the United States, is the excitement of physicians and nurses when they see the results of Barostim on their patients. So that's the common ground. We're starting from this basis. We know they're excited. They're seeing the results. They've been seeing the results for therapy and they want to continue to make it. We know the product is paid for in Germany. So the only thing that [Indiscernible] us in Q4, but even started before that, was COVID. Now, in Q4 it's exacerbated when Germany shut down ahead of Delta variant and the Omicron variant back to back. If you recall, in mid-November, late-November, Germany shutdown due to Delta and then they switched directly from Delta to Omicron without a break in between the two. Now, that's the environment, that's what's going on with our therapy in the market but when I think about how I have managed the situation in Europe and the strategy, even before the IPO, I decided for 2021 not to invest in Europe but rather spend every dollar that we are planning to spend in the United States. Rightfully so, you know, this is -- we're starting to invest in the U.S. We've got FDA approval, we've got reimbursement and we're building solid foundations. We assumed, Jared and I, that without increased investments in Germany, we can stabilize and keep it flat or slightly growing, 5% or 6% year-over-year. In fact, it doesn't grow if you flatten our because you'll be sending the wrong signals to your customers about your future support, the near future investment in that country. So we reversed trend that we started in Q3. We allowed Thomas (ph) to start looking for talents and hiring them in Q4. That said, it could be a little bit too late here, the talent that we added in Q3 and Q -- particularly in Q4 would not be effective in our estimates until possibly the end of this year. So that's why when we look at -- when we look at our forecast for 2022, we are taking 2021 and assuming it's flat, despite the fact that we added a couple of headcounts to Europe.

Great. Thanks a lot.

Thank you, Robbie.

Thank you. Our next question comes from the line of Matthew O'Brien with Piper Sandler. Your line is open.

Thanks for taking my questions. Jared, just for clarification. You said $3.6 million to $4 million for Q1 revenues, is that right?

Yeah, that's correct, Matt.

Okay. So that's obviously down sequentially versus Q4. I get the whole seasonality side of things. But just Q4 beat our number in the U.S. We're still seeing some COVID impacts. Can you just talk about the level of impact? I think, I knew you started talking about it a little bit. But just the level of impact you're still seeing on the volume side of things? And then, do you need that prioritized group to really kick in before you can get some of those new centers that you've added to really ramp from here? And then, I do have a follow-up for Jared as well.

So Matt, maybe I'll jump in just on the numbers real quick. When we put out the guidance of $3.6 million to $4.0 million what we were really pushing towards was knowing what was going to happen from Omicron, right. We were a week into January, we were starting to see cases spike all throughout the U.S. and also continuing to cause problems for elective procedures over in Germany. And so when we looked at what we would be able to accomplish in the first quarter, we were going in with the assumption that January was going to be a pretty tough month. Then we'd be able to recover from a fast peak, fast fall from Omicron in the month of February and March. And really the way that it's played out is kind of as expected for that Q1 guidance so that we saw a pretty significant slow down in the number of procedures being performed in the month of January and then as we get into the first and now the second week of February, we're starting to see some recovery on those procedure numbers.

Okay. And then maybe for Nadim, just again, maybe under the surface, what you're seeing from a new center existing set of utilization perspective.

Excellent question Matthew. First let me add to what Jared was saying about COVID yet, we expected for the Q4 that Omicron would hit us in January and then things will start settling down. So that's what we've seen with the Delta wave back in the summer. And we're starting to see increased utilization. Now the question is, is our expectation for February and March to recover for the fourth quarter in line with our ability to get to the estimate, to the guidance [Indiscernible] Q1 and we believe the answer is absolutely yes. So from that perspective, that's good news the fact that we are seeing an improvement in the COVID situation late in January or early February. In regards to customers and what we're seeing at the sites level, we added into four, eight sites. We signed up contract with more than eight. The beautiful thing though that was happening Matthew is we've seen an increased utilization in the sites that have been with us more than 12 months. Number one, there is no fatigue. It's not a novelty where they jump on a bandwagon and then they switch, no. [Indiscernible] is the more they use it, the more they see the long-term benefit on their patients, the more they want to use it. The more they verify that the payment is coming without any hiccup, the more they want to use it. If you recall, Jared was forecasting for the long term that we will get to an average of one patient per center per month in the long run. Right now we have a handful of centers that we've open up more than a year ago that have exceeded these numbers. So we're very satisfied with what you're doing, Matthew.

Got it. I appreciate that. And then the follow-ups for Jared, on the cost side of things. First of all, just for clarification, your OpEX -- when you talk about OpEX, you're just talking SG&A plus R&D. Is that right?

That's correct.

Okay. So just to skip to that, that number for the year again is a bit higher than I think some people were expecting, that we were modeling. So I don't know how much of that is the prior off group, doesn't seem like the DTC is a huge chunk of that, but can you talk about those two things and the returns you expect to get on those two things? And then just how -- what else is really contributing to a higher OpEX number here in '22. And then when it may stabilize a little bit from these elevated levels? Thanks.

So I'll go through the couple different components here. First on, research and development line. We are expecting to see an increased spend in net line in 2022 compared to 2021 as we look at the different programs that Nadim mentioned, number one, the BATwire program we're going to continue to enroll more patients

in that program and treat more patients this year than what we did last year. So we will see a step-up in investment in that program. The second is related to the morbidity mortality data collection. So there is efforts in spend that will go into the data collection, but then also in the monitoring of all the sites before we'll be able to submit the data to FDA. So a lot of that spend will be taking place here in 2022 as well. So we will see a step-up in research and development this year compared to 2021. For the sales and marketing side of the house, we continue to add heads as Nadim mentioned for that account manager positions, so that we can get them trained up over that six month period and open up a territory for each of those account managers. But we're also making investments in market development reps to help lessen the burden on those physician groups so that they need to spend less time educating the referral cardiologists about the therapy so that our team can go out there and take on some of that burden for the team. And then we will continue to make the investments that Nadim mentioned in [Indiscernible], in DTC and other marketing campaigns to make sure that we get out in front of patients, that they know what this therapy can do to help relieve their heart failure symptoms.

Great. Thank you so much.

Yeah. Thanks, Matt.

Thank you. Our next question comes from the line of Margaret Kaczor with William Blair. Your line is open.

Hi everyone. This is actually Brandon on for Margaret. Thanks for taking the question. Nadim, you were talking a little bit about how COVID and then a little bit of the staffing shortages have caused some procedures to be pushed and I think that would be interpretation of you have mentioning that you had signed on more accounts than you were reporting as implanting centers. The question is, kind of curious if you can give a little bit of an intra -quarter update on those delayed cases specifically. Are those accounts that you've signed on starting to ramp back up as Omicron has subsided or is it potentially going to take a little longer or there are some other things you're prioritizing? So just trying to get a sense of the pipeline of patients you already had or accounts you already had, what can the rebound look like in terms of time?

Great question, Brendan. So we've tried to explain the dynamics. But when you look at the impact, the percent of our business coming from accounts open more than 12 months, that percent of our business is going to increase. We started 2021 with 11 accounts open and we end up with 46. This year, we're starting with 46 and we'll be adding about 36 over the year. But you think that the 36 we'll be adding in 2022 over the 46 of last year is almost 40% or 50%. But more than 80% of our revenue unit in 2022 will come from accounts that have already implanted in 2021. You see how that dynamic plays? So it's -- our growth is hinging? Yes, of course, on opening up a new account. But more so is on increasing the utilization on existing accounts. And what -- and you see that ratio is changing over the years, because we're starting from a very small base, and that's why we get to this year, where I'm -- target of 2022, we expect 80% or 82% our revenue to come from the hospitals, or the sites that did the first implant last year. So I don't know if that helps you answer the question that you have fully, Brandon? If not, please [Indiscernible].

No, that's helpful, Nadim, thanks. You were getting to the point of what I was asking, was just trying to understand the cadence of when those accounts activate, given like you said, they're important to growth going forward, but that's helpful color to think about growth in the next three or four quarters. Just another question focusing a little bit on the other comment that you made there in growing your utilization within your existing accounts. Can you talk about what's working in the accounts that are doing really well? You mentioned a handful of them are already doing one implant per month, reaching those long-term goals you had. What's working in those accounts? And as we move through '22, how do you implement that same playbook into the rest of the user base?

When we look back -- It's a great question actually. When we look back about what works well in accounts, it's that they've been working with us 12 months or more. That's the common denominator. Which is great, that means wait and time will heal it, but that's one element. But you cannot just rush on it and saying that everything will be the same. Our patients and physician education campaign continues. And one thing that I mentioned last month when we had the -- during the JP Morgan call, where Robbie asked me the question about what we're doing to alleviate the concerns about the staffing -- shortage staffing and so forth. We look at hospitals. We verify that they've got staff, everything is working. But if we see them struggling, we try to step in and see what are the tasks that we can take on. For example, patient education. Instead of having the physician or the nurse-practitioner spend 15 to 30 minutes to educate the patient about the mechanism of action of better stem of what to expect during -- before, during, and after the procedure. We do this, we can do that, with our team. And that -- those are some of the elements that help us make the business more predictable for our customers, for the sites. Now, if we go back and look at the sites about what's the common trait of the sites over-performing versus those under-performing, there is no rule. I cannot stand here and tell you, well, the economic sites are doing better than the private sites or the [Indiscernible] are doing better than hospitals. It's not, it's a site that has been working with us more than 12 months is doing better than a site that just started the last six months.

Got it. Thank you very much.

Thank you, Brandon.

Thank you. Our next question comes from the line of Bill Plovanic with Canaccord. Your line is open.

Great. Thanks. Good evening. Thanks for taking my questions. Just if you've started commercialization, you've learned a couple of things and from listening to the call, maybe some incremental investments, the prior off team, the market development group team, some of these DTC, I was wondering how much of that is incremental from what you thought 12 months or 24 months ago? And then as you look at what's incremental, how much of that do you think is going to be scalable where it's more of an upfront cost than something you have to kind of add one-to-one over time?

Great question Bill. So prior us, we knew from the beginning that we needed a program, we particularly had learned by observing other similar companies who have an active implantable device, selling it into a market where they did not have full coverage decisions. And it's a temporary thing to try off. It will last for few years but then after a while when we have enough volume to work with payer-by-payer to get them to do the coverage decision analysis on us, and it will be positive, and then they can [Indiscernible] coverage; then yes, the need for the prior off team will shift. DTC is a different beast. We did not expect that we'll be investing in DTC that early in the process. And it's a combination of two things. Number one, observing what worked and what did not work with other companies like I mentioned. And the second is this need to educate patients to alleviate the workload on hospitals. So because of those two reasons, our investment in DTC right now is larger than what we expected to be doing at this stage. Now, if it was not providing us a good return on investment and by return on investment, I'm not meaning get the revenue itself, but rather the leading indicators that would lead us to forecast good revenues in the future, we would not be investing these amounts. Now, will this grow? Yes. And again, how do I know? I'm looking at other companies similar to us and their investment in this field, the need to educate patients at the same time that you are educating physicians, and that doesn't seem to be a substitute to DTC to educate patients directly. Now, the market development team that we have started building to educate the referring physician. This one we talked about it earlier. We decided to do it this year, starting last year with a couple of pilots, and those couple of pilots turned out to be pretty positive. So we were encouraged by this result and we are duplicating this model elsewhere in the country. So that seems to be our operates mundi here, our way of operating as a business. Pick a couple of geographies, try something new and new for us. It could be something that has been utilized forever by other companies. Market development or therapy development apps have been utilized by Medtronic and Boston Scientific and other established companies for many, many years. But for us, it was new. Run it in a couple of geographies, verify that is suitable to our therapy and the dynamics and about [Indiscernible] surrounding our therapy. And then if it works, if the numbers feel good, particularly when we look at the leading indicators, then we started investing more and expanding least. I don't know if Jared here, if you can comment on Bill's question about the numbers themselves.

Yeah, I won't go in details on numbers of what's changed from what we thought a year ago. It is a pretty different business from where we were at that point in time, December 2020, still in the heart of COVID and pre-IPO, less money on the balance sheet and trying to decide where we're going to make investments as a company. But when I look at where we are at the end of 2021, and the investments we're making in 2022, I think it is an ad for the MDRs at this point in time in the business. And again, part of this is driven by the need to alleviate workload on the new customers, taking get programs up and running, get these physicians educated on what this device can do for their patients. For DTC again, it's working with centers that are open for business, can treat patients with our device and starting to educate patients in and around those activated centers so that they know that this therapy is available to them. And that's a bit of a step-up from where we were a year ago because of that success we've seen along the way. On the R&D side of the house, some of this is shifting spend, money that we thought we'd be spending a little bit earlier in 2021, seeing that shift into 2022 and part of that is just driven by COVID and not being able to get some of the work done that we wanted to get done in the last 12 months.

And then if I could have a follow-up. I think the one theme we're hearing, or at least I'm hearing is that the time is your friend and your early accounts are becoming a productive. That's good news, right? It sounds like it's repeatable and you're able to drive it. I guess, is there -- is it like after 12 months historically when you really see that benefit, is it more a six-month type of thing? I mean, 12 months is the number you're giving us, but is there anything else that we could see, the aware it is today. And then these investments, how should we think about this, like this will pull this in the mid instead of 12 months, 6 months, or how do we think about that? And that's all I have. Thank you.

Very good question. What -- when we [Indiscernible] all of the revenue units, starting from T-zero being the time or the day of the first implant as a new account, and you line up all of the accounts like this, and then you add them up and you try to analyze them month-by-month what is happening. You would see first a blip the first 2 months. 1,2,3 revenue units. Then sometimes there's silence for 3,4 months. And then they start doing one every other month for another six months, and then they start going closer to a one month. And I'm talking here averages, all right? That initial blip is their trial period. They try two, three patients. Many of our customers got hurt many years ago when they embarked on a new therapy such as CardioMEMS where they had -- were probably getting reimbursed or with Watchman where the reimbursement was less than their costs initially, if you recall. So before they embark and do ours month after month, administration put a clamp on the physicians to say, "You know what, let's do a few patients. You can observe the clinical outcome on those patients, we can observe the payment on those procedures. And if both are positive, then you can continue. " And that's what we're seeing at the macro level and the good news here, all of our accounts are continuing. As far as I know right now, looking at all of the accounts, all of the 46 accounts have done and continue working with our therapy, which is great news, right? Now, would DTC accelerate this? Possibly after month 6, meaning when they get to month 6, now they go to their organic patient flow. And initially, of course, they start with the sicker patients because…

Great. Thank you for taking my questions.

Thank you Bill.

Thank you. I'm sure no further questions in the queue. I will now like to turn the call back over to Nadim for closing remarks.

Yes. Thank you, Operater. And thanks again, everyone, for joining us for our fourth quarter earnings call. I know it's late in the day, particularly for those on the East Coast. We appreciate your ongoing support and we look forward to updating you on our progress on our next update. Good night.

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.