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

By the time they even sort of have thought through okay. I’m doing great on inpatient, not as well an outpatient sort of all of a sudden, it will be January and they’ll have what we believe will be the 514 higher APC. So it’s – it may – 6 months may feel like a long time by Wall Street standards, but for a hospital’s reimbursement gears, that’s barely a noticeable period of time.

Unidentified Analyst: Got it. Thank you. And then just on the prior authorization, do you guys have any internal support mechanisms or teams that are helping support customers through that? Are you thinking of investing there if this does like a prolonged period of denials going on?

Doug Godshall: There are several things that are going on in support of this now. First, there – and the primary thing I would point to is there has been some action by the medical societies, the American College of Cardiology and Sky, the Interventional Cardiology Society in an attempt to work with specifically Aetna and their third-party eviCore. In terms of rolling out or at least providing sort of a longer adjustment window for this prior authorization practice. So I think that is certainly something that is one that we hope will be effective. The other – there is another society, the OEIS that represents sort of more ambulatory surgical centers. And that group has also started kind of a place to collect information regarding delays in patient care that may be affected or may have arisen as a result of this policy change.

So I believe I’ll first to the action of the various societies out there as being one that represent the entirety of medical care and really the goals of patient care. I think from a Shockwave perspective, we do have a field reimbursement team that has been and remains available to support customers as they seek things like prior authorization and the like. So I think all of those things are in place.

Unidentified Analyst: Thank you.

Operator: Our next question comes from the line of Larry Biegelsen with Wells Fargo. Please proceed with your question.

Larry Biegelsen: Thanks for taking the question. Hey, Doug, I apologize when Adam asked the question earlier, did you say if this is happening with the prior authorization more BTK or above the pushback?

Doug Godshall: Well, it’s all procedures, but the hardest push back or the hardest ones to get through are the Claudicants. In a lot of countries, they don’t even treat Claudicant much because it’s leg pain. And so I think the payers are probably using my sort of conspiracy view as they look at the New York Times article and say, hey, wait a minute, I can delay payment on these patients, and maybe I shouldn’t be paying for them at all. So I’m going to hire this company to become sort of throw sand in the gears and see if we can avoid covering some of these patients because maybe we were paying for too much anyway. Is my best guess what how they are looking at the situation. And so since below-the-knee is predominantly critical in ischemia, not all, but predominantly, that would suggest that the above-the-knee segment is the one that’s getting the is more affected on a percent basis by – or more successfully affected by the prior auth pushback?

Larry Biegelsen: And so my question is, how are you addressing this from an evidence standpoint because when the year times article came out, I thought you guys would be okay because of the PAD, PDI 2, I think, trial, you showed a reduced stent utilization. So from an evidence standpoint, how are you addressing it? And I did have one follow-up.

Doug Godshall: Let I think in the mix on it. Yes. I think one of the things here to clarify is that it’s – this isn’t a really an IVL-specific issue. This is general to PAD interventions. And so the kinds of things that we see is where there is some delay in terms of when the procedure can be scheduled because prior auth is requested, that prior off may take a number of different phone calls and even an escalation procedure to even get through. In other cases, there may be examples where the payer would request that there for a given patient that additional steps be taken. In other words, some other sort of exercise regime or smoking cessation as mentioned here on the call, sometimes pharmaceutical agents prior to the PDI of them that patient actually undergoing the procedure.

So some of this is just related in general to the PDI of a PAD intervention and not so much specific to IVL, where I would agree with you, Larry. There was terrific level 1B evidence to support utilization of IVL. If that patient doesn’t get to the table, and that’s really what we’re talking about here.

Larry Biegelsen: Thank you. Hey, Doug, switching gears. Just on M&A. I’ve been thinking about this, and it would seem like mechanical circulatory support for high-risk PCI would seem to be a natural adjacency for I guess my question is, would you agree? And if so, what are some of the features and milestones you focus on when it’s setting Impella challengers? Thanks.

Doug Godshall: We thought about buying J&J, but they are just – it’s just – it’s too rich. And then Ashley left and that made it impossible to get it just kidding. I’m we are I think that’s a great therapy and particularly for Shock patients, I think it’s going to do a lot of good. We do a lot of cases with Impella. They are obviously the only ones out there. So, we are – we like what that does for patients and there are lots of other therapies out there that we also like the benefit they do for patients. So, we are paying a lot of attention to a lot of different segments and haven’t – obviously, if we were going to announce the deal, we would have announced it in conjunction with this call. So, we have nothing to announce about our BD strategy at this juncture.

Larry Biegelsen: Thanks a lot.

Operator: Our next question comes from the line of Mike Matson with Needham & Company. Please proceed with your question.

Mike Matson: Yes. Thanks. So, I completely understand your point about the outpatient coronary reimbursement and how the six months is in a real long time. But I guess I was just wondering if you could – can you explain kind of what the economics will be for those procedures in that setting without the TPT Like, in other words, how much money will the hospitals be closing [ph] on each procedure, roughly speaking?

Doug Godshall: That’s hard math because it’s all like different, like how – what other devices they use in the procedure, how complicated it is, is it how long does it take. So, I won’t try to come up with an average. But the APC-5193 pays about $10,000 national average. And our device is a little bit less than $5,000 cost. So, there is certainly money left over. And for a long time in the peripheral space, we had a business where the reimbursement was $5,000 and our device cost was close to $3,000. And while that was you got a lot better when we moved up to the 5193-APC on the peripheral side and had a $10,000 payment and here really no pushback on financials anymore. When physicians feel that the device is the right thing for the patient, it’s $5,000 was adequate, $10,000 is more than adequate.