ShockWave Medical Inc (SWAV) Q3 2021 Earnings Call Transcript

ShockWave Medical Inc (SWAV)
Q3 2021 Earnings Call
Nov 08, 2021, 5:00 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Ladies and gentlemen, thank you for standing by, and welcome to the ShockWave Medical, Inc. third quarter 2021 earnings conference call. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session.

[Operator instructions] I would now like to turn the conference over to your speaker today, Debbie Kaster, investor relations. Please go ahead.

Debbie Kaster -- Investor Relations

Thank you, all, for participating in today's call. Joining me today from ShockWave Medical are Doug Godshall, 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 30, 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 materially 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 Factors section of our annual report on Form 10-K on file with the 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. 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.

Doug Godshall -- President and Chief Executive Officer

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 million 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?

Isaac Zacharias -- Chief Commercial Officer

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 seem 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 U.S.

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 U.S. 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, remained strong, comprising 78% of total U.S. C2 revenue for the quarter. As with prior quarters, the initial order quantity remains 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 to replenish 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% of our accounts purchased both coronary and peripheral products. Seventeen percent purchased only coronary and 32% 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 U.K. 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 a 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 DAC countries. I am confident that this team, combined with our distributor throughout the world, will continue driving robust growth of IVL in the international markets. I appreciate the efforts from our growing and increasing the global team in the third quarter as they continue to help customers improve patient care.

Back to you, Doug.

Doug Godshall -- President and Chief Executive Officer

Thanks, Isaac. 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 PAD III 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 reinforce 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 CAD III 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 -- in 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 of IVL -- the impact IVL has on challenging calcium morphologies and how safely and consistently 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 BTK 2, 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 typically -- 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 PAD III 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 one of the -- likely the October meeting next year, which is associated with the 2024 CPT book.

But 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 the 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 has 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 cleanroom became operational, more than doubling our production capacity, which is allowing us to transition our prior production areas in cleanroom 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 turn now -- now turn the call to Dan.

Dan Puckett -- Chief Financial Officer

Thank you, Doug. Good afternoon, everyone. ShockWave Medical's revenue for the third quarter ended September 30, 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 the 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 sales force expansion. International revenue was $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 U.K. 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, the 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% 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 sales force 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.

Doug Godshall -- President and Chief Executive Officer

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 are all here. Thank you, again, for your time today.

Take care and be well. With that, we'll open to the questions.

Questions & Answers:

Operator

Thank you. [Operator instructions] We have your first question from Larry Biegelsen with Wells Fargo. Your line is open.

Larry Biegelsen -- Wells Fargo Securities -- Analyst

Good afternoon. Thanks for taking the questions and congratulations on a really nice quarter. Can you hear me OK, Doug?

Doug Godshall -- President and Chief Executive Officer

Yeah. Thanks, Larry.

Larry Biegelsen -- Wells Fargo Securities -- Analyst

Doug, I wanted to start with the lower extremity of 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 new reimbursement? And I have one follow-up.

Doug Godshall -- President and Chief Executive Officer

Yeah. So atherectomy is -- our numbers have 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. We're -- 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. Your -- 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.

Larry Biegelsen -- Wells Fargo Securities -- Analyst

That's helpful. Doug, I'm going to ask the 2022 question. You gave us guidance for Q4. Any puts and takes that we should consider? Obviously, you see where consensus is right now.

And should we expect some contribution from Japan? Thanks for taking the questions.

Doug Godshall -- President and Chief Executive Officer

So, 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.

Larry Biegelsen -- Wells Fargo Securities -- Analyst

Fair enough. Thanks for taking the questions, guys.

Operator

We have your next question from Adam Maeder with Piper Sandler. Your line is open.

Adam Maeder -- Piper Sandler -- Analyst

Hey, guys. Thanks for taking the questions and congrats on the nice quarter. Wanted to start with just the guidance raise 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, hospital, and staffing constraint standpoint. It sounds like there's 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 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 thoughts around a potential backlog that may have accumulated in Q3? And then I had a follow-up.

Doug Godshall -- President and Chief Executive Officer

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 said we're not good at forecasting COVID.

So we'll say, once again, we forecast COVID at our own peril. What we tried to do last quarter was do our best guess at what we thought would be a meaningful impact on elective procedures. And unfortunately, we were right, that did come to pass. Luckily, 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 try 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 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 try to risk-adjust our numbers somewhat, but still, obviously, a significant lift versus the Q3. And then you want to touch on peripheral?

Isaac Zacharias -- Chief Commercial Officer

Sure. 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 to 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 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 kind of variability as different waves of COVID spread through the population. It's encouraging that vaccine rates are going up, but it's just -- it's really hard to predict.

And so we're just trying to -- as Doug said, trying to do the best we can to serve our customers, make sure that patients are getting treated, and then monitor how things are going.

Doug Godshall -- President and Chief Executive Officer

Yeah. And on backlog, I mean, our -- 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 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 were waiting, but I've yet -- we've yet to see a real -- like all of a sudden, you double or have seen a surge because there's also the, oh, yes, hospitals have resource constraints for how much they can treat, which is also exacerbated by the staffing shortage. So it's a complicated milieu, but we're not -- we wouldn't -- and I think our numbers don't reflect a surge effect.

Adam Maeder -- Piper Sandler -- Analyst

OK. Understood. I really appreciate all the color there, guys. And then just for the follow-up, maybe one for Dan just on the P&L and opex spending.

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 ramp in EPS trajectory on a go-forward basis? Or would we have some catch-up in spend in 2022? Obviously, there's a lot of opportunity ahead of the company. So any color there would be helpful. Thank you.

Dan Puckett -- Chief Financial Officer

Yeah, no different guidance 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're still we've got some adds 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.

Adam Maeder -- Piper Sandler -- Analyst

That's helpful. Thanks, Dan.

Operator

We have your next question from Bill Plovanic with Canaccord.

Bill Plovanic -- Canaccord Genuity -- Analyst

Great. Thanks. Good evening. Thanks for taking my questions First, just like to start off with more big picture.

Doug, one of the strategies you put in place with coronary was that the hospitals had to stock the product, which is going to -- ends up becoming a lever point in the future for distribution because you can just -- the reps don't have to be in every case. My question is -- 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 in the way hospitals think about the peripheral product?

Doug Godshall -- President and Chief Executive Officer

Yeah. Our approach of a very skinny initial purchase at the site was in part a way of ensuring that we had sort of commitment in buying from the hospitals 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 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 the -- that initial small inventory slug.

I think peripheral -- our observation is the peripheral will, for the foreseeable future, be a bit more labor-intensive. 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 in peripheral procedures. And so as we continue to expand our sales 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're -- we continue to be encouraged that there's -- 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 or TAVR if they don't do peripheral. So there's a tremendous amount of overlap among our cardiologists. Let's 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.

Bill Plovanic -- Canaccord Genuity -- Analyst

Got you.

Isaac Zacharias -- Chief Commercial Officer

Bill, yes, this is Isaac. I'll also add to that. The -- we have 11 SKUs in our peripheral portfolio and only four on coronary. So it's easier for the customer to stock for their cases with purchased inventory from a kind of a financial outlay perspective.

Second thing is we launched peripheral 3 or so years ago now in the U.S. with very little data and very kind of -- it was a really new product in a new product category. 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 if you look at our business today on the peripheral, it continues kind of quarter on quarter.

The amount that we do in terms of the sold product versus consigned or trunk stock is higher every quarter, and we're incentivizing our customers to do that.

Bill Plovanic -- Canaccord Genuity -- Analyst

OK. Thanks. And then the follow-up question, just as we look at the numbers, obviously, coronary was a big driver here. I mean it's been a tremendous launch.

Peripheral was 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 I think you gave [Inaudible] expect it back up again. But I mean that's the biggest challenge, right, if you've got one force selling both. And can you continue with the one force selling both as you think of '22 and beyond at least from where you sit today? And that's my question.

Dan Puckett -- Chief Financial Officer

That's the right question, Bill. Looking at the Q3 number in the U.S., sequentially -- you know, forget about COVID. Sequentially, Q3 is very seasonal, right? It's the lowest procedure 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 by people and end customers, physicians.

And so I think the seasonality in Q3 was particularly pronounced. And that's -- I think you've seen that in other reports from other companies, compound that with the elective procedure slowdown with pockets of COVID, particularly in the south on electric 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. We schedule the launch and kind of 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.

Bill Plovanic -- Canaccord Genuity -- Analyst

Thanks for taking my questions.

Operator

We have your next question from Danielle Antalffy with SVB Leerink. Your line is open.

Danielle Antalffy -- SVB Leerink -- Analyst

Yes, hi. Good afternoon, everyone. Thanks so much for taking the question.

Doug Godshall -- President and Chief Executive Officer

Hi!

Danielle Antalffy -- SVB Leerink -- Analyst

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, atherectomy users versus non-atherectomy users, are you seeing -- so I know it's hard because there's COVID and all of that. But who are you seeing the most aggressive adopters of the coronary device? Maybe it's across board. Would love some more color about what the typical high-volume user here looks like?

Doug Godshall -- President and Chief Executive Officer

Well, the highest volume PCI operators will tend to also be those who do atherectomy because you are treating 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 launch, 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, we want -- 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.

It does enable you to get very strong penetration at a site to get full exposure to everyone doing PCI. So sort of by definition, your higher volume users are going to -- 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 different -- some technologies can't be done -- 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, nonsurgical backup sites will be non-atherectomy sites, not always the case, but often. So, it's a blend, and I don't -- because of the volume bias toward atherectomy users, our utilization will also probably be biased toward 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 in cases where atherectomy isn't as applicable and not at the expense of atherectomy.

Danielle Antalffy -- SVB Leerink -- Analyst

OK. That's super helpful. And then just you alluded to that call we had. I'm just curious about, you know, one of the data points we heard was around, you know, the lack of coverage for -- some pushback from private payers, which I appreciate that's such a small piece of the total PCI market.

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 lean more toward 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.

Doug Godshall -- President and Chief Executive Officer

And I've also got Rob Fletcher, who is our VP of marketing and market access here. We -- our aged population tends to be heavily skewed toward the Medicare population. Our average age in our trials tends to be about 73. And so we are -- whereas PCRs on average are maybe 65%, 70% Medicare where 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 private peripheral and coronary.

Rob Fletcher -- Vice President, Marketing and Market Access

Yeah. Yeah. So generally, you're right to ask the question that, you know, the coverage can be more of a concern for private payers. These are 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 you stats in terms of percentage of private pay versus Medicare at the moment, generally speaking, 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 or 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 -- you know, it's not been a large issue that we've been experiencing. Also, I'll just point to the fact that we have staffed up and hired a field reimbursement team.

And among their duties, they are available to assist customers with claims denials or appeals as they emerge. So 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.

Danielle Antalffy -- SVB Leerink -- Analyst

OK. Thanks so much.

Doug Godshall -- President and Chief Executive Officer

Thank you, Danielle.

Operator

We have your next question from Cecilia Furlong with Morgan Stanley. Your line is open.

Cecilia Furlong -- Morgan Stanley -- Analyst

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 kind of what you've seen in early days with NTAP as well.

Doug Godshall -- President and Chief Executive Officer

Great. Thank you for taking the question. So, I'd say the blend of NTAP and transitional pass-through is that they have enabled us to continue 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 could find -- 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 the -- all of the other phenomena that have created the abnormality of procedure flow, COVID, seasonality, staffing changes, etc., it's really hard for us to come through our numbers and draw a direct -- these 30 accounts absolutely use more -- or 50 accounts or 100 accounts or whatever use more because you had a transitional pass-through that kicked in. We've searched for that evidence because we certainly hear customers tell us. It -- 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 ShockWave as selectively as they would have had to were those not in place.

Cecilia Furlong -- Morgan Stanley -- Analyst

OK. 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-extensive IVL, how you're looking at that today? And thank you.

Doug Godshall -- President and Chief Executive Officer

Yes, it's been encouraging. And Isaac is close to it, so I'll let him jump in again.

Isaac Zacharias -- Chief Commercial Officer

Yes. 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 eight millimeters on that product line, seven is the largest M5 balloon today. I think that might add some. But I think, you know, generally, this will -- probably most would 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, but -- new cases, but I'd expect mostly it's just cannibalistic.

Cecilia Furlong -- Morgan Stanley -- Analyst

Thank you for the questions.

Doug Godshall -- President and Chief Executive Officer

Yes.

Operator

I'm showing no further questions at this time. I would now like to turn the conference back to Mr. Doug Godshall, president and CEO, for any closing remarks.

Doug Godshall -- President and Chief Executive Officer

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.

Operator

[Operator signoff]

Duration: 47 minutes

Call participants:

Debbie Kaster -- Investor Relations

Doug Godshall -- President and Chief Executive Officer

Isaac Zacharias -- Chief Commercial Officer

Dan Puckett -- Chief Financial Officer

Larry Biegelsen -- Wells Fargo Securities -- Analyst

Adam Maeder -- Piper Sandler -- Analyst

Bill Plovanic -- Canaccord Genuity -- Analyst

Danielle Antalffy -- SVB Leerink -- Analyst

Rob Fletcher -- Vice President, Marketing and Market Access

Cecilia Furlong -- Morgan Stanley -- Analyst

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