ShockWave Medical, Inc. (NASDAQ:SWAV) Q3 2023 Earnings Call Transcript

Travis Steed: Got it. Helpful. And would you be willing to take a guess at the impact on revenue is like $5 million or $6 million from the reimbursement thing if you want to hear that, I’d love to hear that. And then Doug, you’ve been saying you’re comfortable with – the Street’s 25% growth in 2024. This is a new variable on the reimbursement side. So would just love to hear how you’re thinking about 2024 in light of the preauthorization stuff?

Doug Godshall: Yes. As I said in the prepared remarks, we remain comfortable with the 920 consensus. I think the mix is going to be more coronary based, probably because of all the positive new product launch reimbursement benefits, etcetera. And when we factor in the recovery – the gradual recovery of China, which we think will happen. But next year, our China model is lower than it was initially. And we think we’re going to be a little bit cautious going into the year on peripheral. But despite all that, we’re very comfortable with the 920.

Travis Steed: Great. Thanks a lot.

Operator: Our next question comes from the line of Adam Maeder with Piper Sandler. Please proceed with your questions.

Adam Maeder: Hi, good afternoon. Thank you for taking the questions. Two for me and one quick clarification. I guess on the clarification front, are you able to break out Claudicant versus CLI? What is that peripheral case mix in the U.S. look like for you guys historically?

Doug Godshall: It’s hard for us to know. The broad case mix is probably a sort of 40% ish, Claudicant 60% ish percent CLI. So we’re excited that we’re going to have a fantastic CLI portfolio or below-the-knee portfolio starting in the middle of next year – towards the end of next year with E8 and then JAVELIN. Since we’ve never really participated in earnest in that below-the-knee segment. But I think we have to assume that we’re in or above the knee, we’re probably not too dissimilar to the average and above the knee is probably more biased towards Claudicant than CLI because CLI is heavily below-the-knee segment. So that would suggest that above the knee is greater than a 50% Claudicant mix.

Adam Maeder: That’s helpful, Doug. Thank you for that. And then for the next question, I wanted to ask about outpatient coronary reimbursement? How are you thinking about any potential impact to your business in the back half of ‘24 after the TPT sunsets in the middle of next year? T&S did not map to APC-5194. So do you think there is going to be an impact there? And then can you speak to your level of confidence that this gets addressed in the next rule-making period and goes into effect Jan 1, 2025?

Doug Godshall: So I’ll start with the impact on the business. We still think de minimis to no impact on our business in that period. We’ve got two great reimbursement drivers that will be well understood by the middle of next year when TPT sunsets and then soon thereafter, will be the proposed rule for 2025. So Rob, I don’t know if you want to – and no change in confidence.

Robert Fletcher: No changing confidence. It remains again, a question of not if, but when. And the conclusion of the transitional pass-through program and the assignment of long-term reimbursement is on docket for the coming year where Adam, it was not on the docket this year. We were just asking them to proactively. So we remain confident in the analysis of the data that hasn’t changed, and we remain confident that CMS will address this issue on the docket next year.

Adam Maeder: That’s very helpful. Thank you. And for the last question, I just wanted to flip over to margins. Q3 operating margin had a nice sequential step-up over Q2 levels better than we were modeling. Just any color on Q4. It sounds like you’ve reaffirmed the guide of 20% to 22% for the full year, but that seems maybe a little bit conservative at least at the bottom half of the range. So wanted to just get more color there. And then I have the Street modeling 24% operating margin for 2024. Wondering if you have any reaction to that figure at this point in time. Thank you.

Dan Puckett: Sure, Adam. Yes, we’re pleased with the margin in Q3. We do expect a little uptick on OpEx in Q4 related to sales and marketing. We’ve got a lot of conferences, a lot of programs from education. R&D clinical. So the margin will probably dip. But on your point on the 20% to 22%, we’re expecting it to be in the upper range at this point in time. So still in line with the upper range. Thanks for highlighting that. And on the 24 – I think 24% in ‘24, we’re not giving guidance. We talked about our kind of trajectory on Innovation Day. And for now, just kind of focus on that.

Adam Maeder: Okay, thanks again.

Operator: Our next question comes from the line of Bill Plovanic with Canaccord Genuity. Please proceed with your question.

Unidentified Analyst: Hi, everyone. It’s John on for Bill tonight. Thanks for taking our questions. Maybe also just to circle back to the outpatient question and maybe ask it a different way for you, Doug. what’s the current mix between inpatient and outpatient in coronary? I know historically, it’s on around 50-50, but I’m curious if that’s changed? Or do you see that changing next year or these reimbursement changes? And how are your message to customers is around the outpatient gap in the second half of next year? Thanks.

Doug Godshall: Yes. I – we don’t have data that indicates it’s different – that our business is any different than the 50-50 historical split and the general historical trend, we don’t have dated numbers other than a few years ago. So we’re not we’re still operating under the sort of inpatient outpatient 50-50 assumption, and it seems to – when we sort of anecdotally talk to customers, some people are really heavy in patient if they get a lot of referrals and some patients are heavier. Some of the hospitals are heavier outpatients. So I think it’s safest to assume 50-50. I don’t think even though the DRGs are like handsome and at teaching centers, they are even more handsome. They are really healthy if you’re in an urban teaching center because they have different rate than, say, an urban – or a sub-rural hospital, for example.

But I don’t think many people are going to say to a patient, I’m going to keep you overnight for an extra night because I can get a higher DRG. I don’t know if that’s your question, I think it will probably – they are going to treat the patient in the way that they think is best and appropriate clinically. And they will be delighted that they are going to get paid a nice additional remuneration as I practiced that word. You got that, we got to write that time. And when it’s an inpatient, they all like it even better because the hospital will be in a really good financial position. And I think back to the sort of why is the second half of the year not going to matter in terms of a gap with the TPT until you get a final APC. They are going to look at the aggregate financial improvement that they are getting on IVL out July and then it’s a short gap, and they’ll have a strong habit of doing what’s right for the patient at best or several years of using C2 and even more C2+.