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spk04: Ladies and gentlemen, thank you for standing by and welcome to the Shockwave Medical Inc. 3rd Quarter 2021 Earnings Conference Call. At this time, all participants are in listen-only mode. Later, we will conduct a question and answer session, and if you would like to ask a question during that time, simply press star 1 on your telephone keypad. If anyone should require assistance during the conference, please press star 0. I would now like to turn the conference over to our speaker today, Debbie Custer, Investor Relations. Please go ahead.
spk00: Thank you all for participating in today's call. Joining me today from Shockwave Medical are Doug Gottschall, President and Chief Executive Officer, Isaac Zacharias, Chief Commercial Officer, and Dan Puckett, Chief Financial Officer. Earlier today, Shockwave released financial results for the quarter ended September 30th, 2021. A copy of the press release is available on Shockwave's website. Before we begin, I would like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results, or performance are forward-looking statements. All forward-looking statements, including without limitation statements relating to our sales and operating trends, business and hiring prospects, financial and revenue expectations, and future product development and approvals are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties, including the impact of the COVID-19 pandemic that could cause actual results or events to material differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, Please refer to the risk factor section of our annual report on Form 10-K on file with SEC and available on EDGAR and in our other reports filed periodically with the SEC. Shockwave disclaims any intention or obligation except as required by law to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. The conference call contains time-sensitive information and is accurate only as of the live broadcast today, November 8, 2021. And with that, I'll turn the call over to Doug. Thank you.
spk06: Thanks, Debbie, and good afternoon, everyone. Welcome to our third quarter call. Hold on a second. We reported $65.2 million in revenue for the third quarter of 2021, representing an increase of 233% from the same period in 2020. Our C2 product once again led our growth as penetration and utilization continued at a healthy pace despite the challenges of COVID and the Delta variant. Isaac will provide additional color regarding the various dynamics that impacted the third quarter, but we are encouraged to see the waning of COVID's impact in hospitals in the U.S. Hopefully, we're finally past the elective procedure freeze and thaw cycle, which would certainly be a blessing for our customers and their patients. Factoring in the combination of continued traction of C2 and steady elective procedure recovery, but still anticipating some impact on procedure volumes from COVID and staffing shortages, We expect to finish 2021 with revenues in the range of $227 to $228 million. This translates into a growth rate of 235% to 236% over 2020. To provide additional perspective on what we're seeing from the commercial side, I will turn the call over to Isaac, and then Dan and I will share more details on the broader business and financial results from the quarter. Isaac?
spk09: Thanks, Doug. I will start with general commentary around some of the procedural dynamics we saw in the quarter. Despite the impact from COVID-19 and pronounced seasonality, the team put up good numbers. Both the international and U.S. results were impacted by seasonality, as people seemed to take long and long overdue vacations. While COVID hotspots interrupted procedures throughout the quarter, our international business and the U.S. coronary launch did not seem to be materially impacted. However, our US peripheral business, where procedures can more safely be deferred, did experience some negative impact of COVID. Thankfully, it was not at levels experienced last year during the COVID waves, and the situation has improved appreciably in September and October. While we do continue to see some disruption to procedures in the US and internationally due to pockets of COVID and staffing shortages, we hope that this continues to remain isolated and manageable. We are still cautiously optimistic that these factors won't be materially disruptive to our overall business in the fourth quarter. Returning to our third quarter results, our U.S. coronary business continued to exceed our expectations. We are encouraged that C2 reorders, measured as sales from launched accounts, remain strong, comprising 78% of total U.S. C2 revenue for the quarter. As with prior quarters, the initial order quantity remained steady, averaging five units per new account. Given that there are four SKUs, this means customers are continuing to stock a limited number of units and are reordering replenished stock upon use. This is a healthy dynamic for our customers and Shockwave. In the quarter, we averaged 1.3 new coronary accounts per territory per month. As we continue to launch new accounts, this number will continue to decrease in subsequent quarters. That said, we forecast that we will be adding new accounts well into 2022 as we remain disciplined in our launch tactics, account targeting, and focus on peripheral IVL growth. Our team continues to educate customers on the TPT and NTAP to help ensure that they secure the best possible economics for the IVL procedures. It was encouraging to see COVID hospitalizations decrease in August and September. This corresponded to improving trends in our peripheral business in September. We expect to return to quarter-on-quarter growth for the peripheral business as the team continues to drive new account adoption and deeper penetration into existing accounts. In the U.S., we continue to make progress on increasing the number of accounts that use IVL across all applications. During the quarter, 51 percent of our accounts purchased both coronary and peripheral products, 17 percent purchased only coronary, and 32 percent purchased only peripheral. As the business grows, we will continue to add new territories at a measured pace while expecting our sales revenue per territory to increase. I'm pleased with the execution of the U.S. commercial team as they continue to consistently perform at a high level and deliver great results. Turning to international, despite the pronounced seasonality, we were able to post strong results in Q3 and have strong momentum as we enter Q4. We added direct sales forces in the UK and France and expect these teams will bring both increased focus and attention to IVL with existing customers and add new accounts in these countries. I'm very pleased with the quality of the new team members, and they are off to a great start. During the third quarter, there was modest revenue impact from the distributor to direct transitions, Dan will provide details on that later in the call. We now have over 35 Shockwave members based outside of the U.S. with direct sales in U.K., France, and the DOC countries. I am confident that this team, combined with our distributors throughout the world, will continue driving robust growth of IVL in the international markets. I appreciate the efforts from our growing and increasingly global team in the third quarter as they continue to help customers improve patient care. Back to you, Doug. Thanks, Isaac.
spk06: Along with the encouraging commercial execution, we've also had a number of additional achievements and activities across the company. The fall is always a busy time for conferences, and while live attendance has been down substantially across all specialties as the meetings work through their new hybrid model, these events still provide an excellent opportunity to highlight new clinical data. Our PAD3 peripheral study was the subject of a VIVA 2021 late-breaking presentation that looked at the results of the first 752 patients in our observational study arm. This real-world data reinforced both the consistency of results with IVL and also, importantly, the ability for IVL to significantly reduce stent usage in this very complex patient population. The presence of a stent can make future interventions more challenging, so reduced stent use, often described as leave-nothing-behind, is a key objective for doctors treating a majority of peripheral lesions. IVL's ability to modify heavily calcified vessels at very low inflation pressures meaningfully reduces dissections and perforations, which are generally the drivers for adjunctive stenting. And then just last week, the one-year outcomes from our CAD3 study were presented at TCT. These data represent the first one-year analysis of coronary IVL and confirmed the benefit of IVL for lesion preparation prior to coronary stenting. These data demonstrate that modifying calcified arteries with IVL results in a durable safety and efficacy. Also highlighted at TCT was our disrupt CAD pooled sub-analysis, which looked at results across multiple IVL trials and showed that IVL was consistently safe and effective in both men and women. The third meaningful data set presented at TCT was a pooled analysis of OCT sub-studies that we have conducted. While most physicians do not use intravascular imaging when performing PCIs, OCT does an exceptional job of highlighting the impact IVL has on challenging calcium morphologies and how safely and consistently it delivers a substantial lumen gain, whether it is used in concentric or eccentric calcium or in lesions with calcified nodules. And while we continue to follow patients from our existing studies, our team is also busy generating new data to support the use of IVL. At VIVA, we also announced our newest trial called BTK2, which will be a 250-patient study focused on the most complex below-the-knee lesions and will take place at 40 sites with long-term follow-up. The study will include some of the most challenging patient cohorts that are typically excluded from BTK studies. There are currently very few large prospective trials studying the durability of intervention in patients with moderate and severe calcium below the knee. Additionally, while our BTK cohort in our PADD3 observational registry included a significant number of interventions with adjunctive therapy, the BTK study will limit adjunctive therapy, which will enable us to examine the impact of IVL alone. We anticipate beginning enrollment later this quarter. Touching briefly on reimbursement, We are excited to see the increase in payment for above-the-knee peripheral IVL procedures that CMS included in their outpatient prospective payment system, or OPPS, final rule that was published last week. This great news came earlier than we expected. As a result, IVL procedures that are performed above the knee in the outpatient hospital setting will now be assigned the two highest-paying APC codes and will be paid on parity with atherectomy. This is a huge win for our customers. And we see this early action taken by CMS just a little over a year before creating the codes as an acknowledgment of the clinical value of IVL. Most importantly, this will help improve access to IVL for Medicare beneficiaries who stand to benefit from IVL. Last week also brought news from AMA CPT panel that took place in September. As a quick refresher, CPT codes are the primary mechanism for coding and payment of physician professional fees, and the process is governed by the AMA. On the peripheral side, the panel made the decision to postpone finalization of the large and complex redesign of the code set associated with lower extremity revascularization, or LER, procedures. We have previously noted that the complexity of the LER CPT restructuring effort led us to expect that it would need to continue past the September meeting. This now moves a future CPT panel meeting, as we had expected, likely the October meeting next year, which is associated with the 2024 CPT book. The bottom line here is that nothing significant changed here versus our expectations, and we are encouraged by what seems to be continued progress. On the coronary side, the CPT panel established a Category 3 add-on code for IVL, While we have had many updates over the last year for C2 showing progress in coding and payment for hospitals, both inpatient and outpatient, the addition of this Category 3 code is the first time we have made progress in establishing coding and payment for physicians. The add-on code will allow physicians an ability to collect additional professional fees for the first time and will enable them to collect professional fee when IVL is performed in addition to a stent procedure. This is a good thing for customers, and we look forward to continuing to work with the medical societies to evolve from the Category 3 add-on to a Category 1 CPT code. It is important to note that this Category 3 code does not impact hospital or ASC payments that have been awarded for coronary IVL, such as the NTAP and transitional pass-through. We are fortunate to have been able to sustain our growth despite the myriad macro challenges that face so many businesses today. We've also been very focused on ensuring that we do not suffer some of the supply chain challenges that are becoming so pervasive. Throughout the quarter, we've been putting the finishing touches on our upgraded manufacturing facility. In July, our new expanded clean room became operational, more than doubling our production capacity, which is allowing us to transition our prior production areas and clean room to R&D activities and pilot lines. We continue to have no back orders for 2021 and do not anticipate any for 2022, despite our significant growth rates. With that, I will now turn the call to Dan.
spk10: Thank you, Doug. Good afternoon, everyone. Shockwave Medical's revenue for the third quarter in its September 30th, 2021 was $65.2 million, a 233% increase from $19.6 million from the third quarter of 2020. U.S. revenue was $52.8 million in that third quarter of 2021, growing 374% from $11.1 million in the third quarter of 2020. The increase included $36.9 million from the coronary product Shockwave C2, which was launched in the U.S. in February this year. The growth in the U.S. was also enhanced by continued Salesforce expansion. International revenue is $12.4 million in the third quarter of 2021, representing a 47% increase from $8.5 million in the third quarter of 2020. The growth in international revenue over the prior year reflects the impact from pandemic recovery, as well as increased adoption in existing geographies. Sequentially, international revenue was down. However, if adjusted for the UK and France distributor to direct changeover, international revenue in the third quarter would have been up 7% versus down 5% as compared to the second quarter of 2021. Looking at product lines, our peripheral products, Shockwave M5 and Shockwave S4, accounted for $17.7 million of total revenue in the third quarter of 2021, compared to $12.3 million in the third quarter of 2020, a 44% increase. Our coronary product, Shockwave C2, accounted for $47.2 million of total revenue in the third quarter of 2021, compared to $7 million in the third quarter of 2020, representing a 575% increase. In addition, a sales of generators contributed $0.3 million in revenue in the third quarter of 2020, which is the same as the third quarter of 2020. Gross profit for the third quarter of 2021 was $54.2 million compared to $14.3 million for the third quarter of 2020. Gross margin for the third quarter of 2021 was 83% as compared to 73% in the third quarter of 2020. Improvement in gross margin was partly driven by product mix, along with continued improvement in manufacturing productivity and process efficiencies. Total operating expenses for the third quarter of 2021 were $51.4 million, a 90 percent increase from $27.1 million in the third quarter of 2020. Sales and marketing expenses for the third quarter of 2021 were $28.4 million, compared to $13.6 million in the third quarter of 2020. The increase was primarily driven by Salesforce expansion in the U.S. R&D expenses for the third quarter of 2021 were $13.7 million compared to $7.9 million in the third quarter of 2020. The increase was primarily driven by headcount growth. General and administrative expenses for the third quarter of 2021 were $9.3 million compared to $5.6 million in the third quarter of 2020. The increase was primarily driven by higher headcount to support the growth of the business. Net income for the third quarter of 2021 was $1.9 million compared to a net loss of $12.9 million in the third quarter of 2020. Basic net income per share for the period was $0.06. Diluted net income per share for the period was $0.05. We ended the third quarter of 2021 with $183 million in cash, cash equivalents, and short-term investments. At this point, I'd like to turn the call back to Doug for closing comments.
spk06: Thank you all for joining us today. I'm so proud of our team and so impressed by our customers and investigators for their ability to persevere and to maintain such high standards for patient care throughout this tumultuous time. It speaks volumes to them as people, and we feel so fortunate to be able to provide them with a technology that is able to meaningfully improve outcomes, which ultimately is why we're all here. Thank you again for your time today. Take care and be well. With that, we'll open to questions.
spk04: Thank you. At this time, I would like to remind everyone, in order to ask a question, please press star 1 on your telephone keypad. Again, that is star 1 to ask a question. We have your first question from Larry Bigelson with Wells Fargo. Your line is open.
spk02: Good afternoon. Thanks for taking the question, and congratulations on a really nice quarter. Can you hear me okay, Doug?
spk06: Yep. Thanks, Larry.
spk02: Doug, I wanted to start with the lower extremity, the above-the-knee reimbursement change, and how should we think about IVL penetration above the knee with the new reimbursement? I think there are about 800,000 above-the-knee procedures. I think you said about half are calcified. Where do you think atherectomy penetration is today? It looks like it's about 20%. And where do you think IVL penetration can go over time with this, you know, new reimbursement? And I had one follow-up.
spk06: Yeah. So atherectomy is – our numbers have it a little bit higher than that for at least hospital-based penetration. OBL-based penetration is obviously significantly higher because of the reimbursement differences in OBLs. You know, it's certainly nice to at long last take away some of the economic friction that has been in place on the peripheral side ever since we launched four years ago. So it won't be harmful, but we have not, at this juncture, we haven't sorted out exactly how much of a positive impact the improved in-hospital payments are for the outpatient procedures. I think your numbers are about right. Depending on the vessel bed, some vessels are like 70% calcified, some are 40% calcified, but the periphery is certainly a substantially longer set of vessels and also substantially more calcified set of vessels than the coronaries are. So it's nice to be in a position where we are reimbursed at a level where we feel like we should have been all along.
spk02: That's helpful. Doug, I'm going to ask the 2022 question. You gave us guidance for Q4. You know, any puts and takes that we should consider? You know, obviously, you see where consensus is right now, and should we expect some contribution from Japan? Thanks for taking the questions.
spk06: Working backwards, Japan, what we've indicated is we expect to be approved in the first half, sort of end of first quarter, beginning of second quarter, somewhere in there before end of June, and that we would then have to go through the reimbursement application process, which is six to nine months. So we see Japan as a 2023 revenue story. And in terms of the revision to – well, we have not guided for 2022, so there's nothing to revise, and we'll be giving 2022 guidance when we turn the calendar and are giving our Q4 earnings call.
spk02: All right. Fair enough. Thanks for taking the questions, guys.
spk04: We have your next question from Adam Meiter with Piper Sandler. Your line is open.
spk07: Hey, guys, thanks for taking the questions and congrats on the nice quarter. Wanted to start with just the guidance raised and the implied Q4 guidance and just wanted to flesh that out a little bit more in terms of what's contemplated from a COVID-19 standpoint, you know, hospital and staffing constraint standpoint. It sounds like there's, you know, something baked in for all of those items, but just would like to hear you kind of give us a little bit more color there. And then how do we think about you know, the trends across the business lines. I think if I heard correctly, you expect the peripheral business to grow sequentially in Q4 relative to Q3. Did I hear that correctly? And then just any, you know, thoughts around a potential backlog that may have accumulated in Q3 and then add a follow-up.
spk06: Yeah, I'll tag team with Isaac on this, Adam. Thanks for the question. so I feel like this is the sixth quarter in a row and we've said we're not good at forecasting COVID. So, so we'll say once again, um, we, we forecast COVID at our own peril. Uh, what we tried to do last quarter was do our best guess at what we thought would be a, um, a meaningful, uh, impact on, uh, elective procedures. And unfortunately we were right. That did come to pass. Uh, luckily, um, we did even better than we anticipated in coronary, and that was less affected, as Isaac said, by COVID wobble. Heading into the fourth quarter, we tried to do the same thing again. We feel like the fourth quarter will be impacted but less than the third quarter was, so consistent with what our sort of projection had been back during our second quarter call. And And the harder thing, well, that's hard to gauge, but then you add in the some hospitals are having staffing shortages, other hospitals are not. So we anticipate there will be some impact. And it's just hard to know for sure exactly to what degree. So we tried to risk adjust our numbers somewhat, but still obviously a significant lift versus the Q3. And then you want to touch on peripheral?
spk09: Sure. You know, I think it is hard to predict, as Doug said. As we looked at Q3, and you guys have heard commentary from other companies, you've talked to physicians, there was certainly an impact to electric procedures on peripheral in the quarter. I think as you're turning the calendar, TCT last week, you talked to some physicians who were from the upper Midwest, and they're starting to see a little more of an impact on hospitalizations from COVID. The physicians in Florida, which, you know, had, they said it was the worst, the ones I talked to said it was kind of the worst impact on procedures that they had seen in any phase of the pandemic there in Florida. They've seen a backlog now of coronary cases coming back in and some peripheral cases. So I think we're just going to have this, you know, kind of variability as different waves of COVID spread through the population, you know, encouraging the vaccine rates are going up. But it's just really hard to predict. And so we're just trying to, as Doug said, try to do the best we can to serve our customers, make sure that patients are getting treated, and then monitor how things are going.
spk06: Yeah, and on backlog, I mean, historically our observation is there's a double backlog. There's a backlog on patients getting diagnosed and a backlog of patients getting treated. So we've never seen a – an overcorrection on the upside of procedures because you needed to then refill the funnel in the places where you were having the biggest procedure backlog. So some incremental benefit from a backlog of treatments that we're waiting, but we've yet to see a real, like all of a sudden you double or seeing a surge because there's also the, oh yeah, hospitals have resource constraints for how much they can treat, which is also exacerbated by the staffing shortage. So Um, it's a, it's a, it's a complex, complicated milieu, but we're not, we, we wouldn't. And, and, and I think our numbers don't reflect a, a surge effect.
spk07: Okay. Understood. I really appreciate, uh, all the color there guys. And, and then just for the followup, um, maybe one for Dan, just, uh, you know, on the P and L and all that spending, um, You know, would love to just kind of get a better handle on how we should think about spend in subsequent quarters. You guys turned the corner here and reached profitability this quarter, a nice positive surprise. I guess the question is how to think about spend going forward and just as it relates to the bottom line, should we expect a positive ramping EPS trajectory on a go-forward basis or not? But we have some catch-up and spend in 2022. Obviously, there's a lot of opportunity ahead of the company. So any color there would be helpful. Thank you.
spk10: Yeah, no different guides than from last quarter where we talked about just continuing to invest in R&D. We've got a lot of great and exciting programs coming forward. We've got some clinical activity. So you're going to see a continued ramp in R&D. We're still investing in sales and marketing, not to the extent related to C2 in the U.S., the launch and the buildup, but we've still got some ads to make there. So you'll still see some increases, especially in probably the first half, but we're also expecting revenue to clearly grow. So we're expecting positive trends on the top line, and we're expecting to squeeze through the bottom line. We're not going to go crazy on OpEx, but we're going to invest in the company.
spk07: That's helpful. Thanks, Dan.
spk04: We have your next question from Bill Flobanek with Canacard. Your line is open.
spk08: Great. Thanks. Good evening. Thanks for taking my questions. First, just like to start off with more big picture. You know, Doug, one of the strategies you put in place with Coronary was that the hospitals had to stock the product, which kind of ends up becoming a lever point in the future. for distribution because the reps don't have to be in every case. My first question is, one, how is that playing out now that we're this deep into the launch? And then, two, is this having any impact on the peripheral business and the way hospitals think about the peripheral product?
spk06: Yeah. Our Our approach of a very skinny initial purchase at the site was in part a way of ensuring that we had sort of commitment and buy-in from the hospital that when we were launching, we knew they were really going to launch. It wasn't just sort of doing a case on consignment or trunk stock. And the pull-through and low price sort of service burden, relatively speaking, of coronary is a testament to the really unique clinical value that the product is delivering to the hospital more than it was getting them to buy that initial small inventory slug. I think peripheral, our observation is that peripheral will, for the foreseeable future, be a bit more labor intensive. There's a There's a funny phenomenon where the same cath lab that does peripheral procedures and coronary procedures, reps are not in the coronary procedures very often at all, but they're in the peripheral procedures all the time. So there's this, I wouldn't say it's dependence, but comfort, familiarity, habit, whatever, of peripheral reps and peripheral procedures. And so as we continue to expand our sales capacity, force or our field force and expand the number of clinical specialists. A lot of it is about covering peripheral procedures, but also continuing to reinforce the coronary procedures. I'd say we continue to be encouraged that there are great synergies by being in the peripheral coronary combo with the same sales and clinical team. A lot of the docs who do coronaries do peripheral, and a lot of the docs who do coronary do large-bore access for TAVR if they don't do peripheral. So there's a tremendous amount of overlap amongst our cardiologists. I'd say a vast majority do some peripheral intervention where shockwave can be helpful. And so the bigger impact is not the purchasing of inventory, it's the customer-level synergy, the physician-level synergy versus any impact of an inventory approach. Gotcha.
spk09: Bill, yeah, this is Isaac. I'd also add to that the, you know, we have 11 SKUs on our peripheral portfolio and only four on coronary. So it's easier for the customer to stock for their cases with purchased inventory than from a kind of financial outlay perspective. Second thing is, you know, we launched peripheral three or so years ago now in the U.S. with very little data and very kind of, you know, it was a really new product in a new product category. You know, fast forward to today with the amount of data we have on the peripheral side and the buy-in that our customers have with that, we're seeing an easier time of getting customers to own their inventory, reduce the amount of consignment, increase the amount of owned inventory they have and reduce the service burden on our reps. And so, you know, if you look at our business today on the peripheral, it continues, you know, kind of quarter on quarter. The amount that we do in terms of sold product versus consigned or trunk stock is higher every quarter, and we're incentivizing our customers to do that. Okay, thanks.
spk08: And then the follow-up question, just, you know, as we look at the numbers, You know, obviously, coronary was the big driver here, and it's been a tremendous launch. Peripheral was, you know, down sequentially, and I'm just trying to kind of discern how much of the peripheral being down is a function of COVID versus sales or field force focus, and then Yeah, I think you gave it back up again. But, I mean, that's the biggest challenge, right, if you get one forced sell in both. And can you continue with the one forced sell in both as you think of the 22 and beyond, at least where you sit today? And that's my question.
spk09: That's the right question, Bill. You know, looking at the Q3 number in the U.S., you know, sequentially, forget about COVID, sequentially Q3 is very seasonal, right? It's the lowest procedural volume of the year in Q3. And what anecdotally, what we heard and saw across the world were long vacations being taken by patients and, you know, by people and customers and physicians. And so I think, you know, the seasonality in Q3 was particularly pronounced. And that's, I think you've seen that in other, you know, reports from other companies. Compound that with the elective procedure slowdown with pockets of COVID, particularly in the South on elective procedures. I think the sequential going backwards in Q3 sequentially on the U.S. peripheral business was wholly a function of the COVID impact and the kind of unusually strong seasonality. I think from a focus standpoint, our team is doing a great job of maintaining their focus on all three product lines, the two below the knee and the coronary. You know, we schedule the launch and kind of, you know, put governors on the coronary launch in order for them to have time to maintain their focus on peripheral. So we think the model is working really well. And we adapt things within the model in terms of comp and quota and service of FCSs within territories. But we have a high confidence at this point that we'll be able to maintain this single sales force selling peripheral and coronary and get good growth out of both businesses in the future. Thanks for taking my questions.
spk04: We have your next question from Danielle Antalsi with SVB Lyric. Your line's open.
spk03: Yeah. Hi. Good afternoon, everyone. Thanks so much for taking the question. Hi. I was hoping you could give a little bit more color or context around how you're seeing the coronary product adopted. And by that, I mean you know, atherectomy users versus non-atherectomy users? Are you seeing this? I know it's hard because there's COVID and all of that, but who are you seeing be the most aggressive adopters of the coronary device? Maybe it's cross-board. Would love some more color about what the typical high-volume user here looks like.
spk06: Well, the highest-volume PCI operators will tend to also be those who do atherectomy because you're treating patients the largest percent of the cases probably in your group, and you also tend to, because of your experience, you'll also tend to attract some of the more complex patients, which require some sort of calcium modification. And so certainly when we launched February, first launched February, March, April, I'd say a very high percentage of our initial adopters were the complex PCI population just like we did in Europe. You want those folks to embrace the technology because then others around them will see that it works for the busiest person in their practice and it's easier to expand. Now generally when we launch at a center, if Dan is the highest volume operator and I might be the lowest volume operator, I'm still doing PCIs, and during the launch, we're still going to train you. And if you've got a case, and it's a calcified case, we're going to want you to get experience with IVL while we're going through the launch process. So another benefit, aside from allowing us to maintain a balanced focus of coronary and peripheral, is the way we launched with only two a month at the most is it does enable you to get very strong penetration at a site to get full exposure to everyone doing PCIs. So by definition, your higher volume PCI operators, if they adopt your technology, will drive more of your volume just because they drive PCI volume. We are certainly seeing cases done in hospitals that don't have atherectomy, cases done in hospitals that don't have surgical backup. like I know you had a call and there was a question as to whether we'd be doing cases in a state like New Jersey where some technologies can't be used in hospitals with no surgical backup, but we're doing cases in New Jersey in hospitals that don't have surgical backup. So those sites will almost always be sites that are not doing, well, generally, non-surgical backup sites will be non-atherectomy sites. Not always the case, but often. So It's a blend, and because of the volume bias towards atherectomy users, our utilization will also probably be biased towards folks who use atherectomy, but our use is not at the expense of atherectomy generally. It's just like we saw in Europe. We are often used in conjunction with atherectomy or on cases where atherectomy isn't as applicable and not at the expense of atherectomy.
spk03: Okay, that's super helpful. Thank you for that. And then just you alluded to that call we had, I'm just, I'm just curious about, you know, one of the data points we've heard was around, you know, the lack of coverage for, you know, some pushback from private payers, which I appreciate that such a small piece of the total PCI market. I mean, I don't know if you have that number, but sort of what the appetite is to even pursue private pay given that it is smaller, but maybe without it, some centers will just, you know, lean more towards other technologies. versus trying to decide which patient gets what. I don't know if you can comment on that or not, but that would be helpful.
spk06: And I've also got Rob Fletcher, who's our VP of Marketing and Market Access here. Our age, our population, tends to be heavily skewed towards the Medicare population. Our average age in our trials tends to be about 73%. And so we are, whereas PCIs on average are maybe 65%, 70% Medicare, we skew higher. And therefore, it's a small minority of our cases or a minority of our cases that are private. But maybe Rob wants to add a little color on sort of our private experience versus across the board, both, I think, probably peripheral and coronary.
spk05: Yeah. Yeah. Yeah, so generally, you're right to ask the question that coverage can be more of a concern for private payers. These are a sort of heterogeneous group of different coverage policies when it comes to new technologies. I think from what we've seen in our commercial experience to date, while our Codes are relatively new, and so I can't quote to you stats in terms of, you know, percentage of private pay versus Medicare at the moment. Generally speaking, you know, we've seen very low percentage of claims denials from both our peripheral and our coronary business. So while there may be some coverage policies that are out there that are – that will – sort of suggest that they don't say anything or they may say they don't cover peripherals, don't cover coronary or both. Generally speaking, the number of cases or claims where we've had to help customers with denials has been extremely low compared to the procedural volume that we perform each quarter. So I think that just speaks to the fact that it isn't – Also, I'll just point to the fact that, you know, we have staffed up and hired a field reimbursement team, and among their duties, they're available to assist customers with claims, denials, or appeals as they emerge. Again, it hasn't been a big issue, but we feel confident in the ability where it has happened to help our customers through overturning those.
spk03: Okay. Thanks so much.
spk04: Thank you, Daniel. We have your next question from Cecilia Furlong with Morgan Stanley. Your line is open.
spk01: Great. Thank you for taking the question. I wanted to ask if you could just comment a bit more on what you've seen subsequent TPT implementation, just from a center willingness, if they were pushed off or held off previously due to economic reasons, just what you've seen from that standpoint over the past several months, and also what you've seen early days with NTAP as well.
spk06: Yeah, so I'd say the blend of NTAP and transitional pass-through is that they have enabled us to continue to to open up new accounts. Certainly in the beginning of transitional pass-through, we saw several accounts that came on board that had been either reluctant to go to their VAC committees or unable to get through their VAC committees, and they were able to get through the process because they were in a position where they could point to much improved economics for the hospital itself. It's You know, you hear anecdotes, oh, this is great, I'm able to use the device now, and my cath lab manager is not upset with me anymore. But given all of the other phenomena that have created the abnormality of procedure flow, COVID, seasonality, staffing changes, et cetera, it's really hard for us to comb through our numbers and draw a direct – These 30 accounts absolutely used more, or 50 accounts or 100 accounts or whatever, used more because you had a transitional pass-through that kicked in. We've searched for that evidence because we certainly hear customers tell us sort of life is better post-transitional pass-through, but there are just too many, like solving a problem that has three different variables is really hard to do and so we're I think the anecdote I think is probably a fairly safe one to conclude which is that the presence of TPT and NTAP makes it a lot easier for the physicians and reduces the amount of pressure on them to use shock waves as selectively as they would have had to were those not in place.
spk01: Okay understood and I wanted to ask as well on M5+, just really what you've seen from the limited launch so far, and as you think forward, just the balance of being cannibalistic to M5 versus market expensive for IVL, how you're looking at that today. And thank you.
spk06: Yeah, it's been encouraging, and Isaac's close to it, so I'll let him jump in again.
spk09: Yeah, so we've had the limited market release ongoing in some of our international markets as well as the U.S. now. Physician feedback has been good, and I think our sales force, the sales force that's been around those cases is excited about the product. It being, you know, how much of it will be cannibalistic and how much will be market expansion? We'll have a larger balloon size in there, up to 8 millimeters on that product line, which 7 is the largest M5 balloon today. I think that might add some, but I think generally this will probably mostly be cannibalistic is the way we see it. It's sort of designed to be very similar to the M5 product and applications of the M5 product with an enhanced feature set. So we might get a little extra business out of it, new cases, but I'd expect mostly it's just cannibalistic.
spk01: Thank you for taking the questions.
spk04: I'm showing no further questions at this time. I would now like to turn the conference back to Mr. Todd Gottschall, President and CEO, for any closing remarks.
spk06: Thanks very much. Thanks, everybody, for your attention. And hopefully things continue to improve on the COVID front so we can stop trying to predict COVID impact on everyone's business in 2022. Thanks, everyone.
spk04: Ladies and gentlemen this concludes today's conference call. Thank you for your participation. You may now disconnect.
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