ShockWave Medical, Inc. (NASDAQ:SWAV) Q4 2022 Earnings Call Transcript

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Michael Polark: Very helpful an interesting topic to a less so one maybe for Dan with the release of the valuation allowance, should we be modeling in a tax rate in 2023 or is there still some NOL to burn through such that a tax accrual is ’24 and beyond.

Dan Puckett: Yes, for book purposes, we’ve guided like 25% on the tax assumption. We do have NOLs. We’ve got $239 million on NOLs. We should burn through those in ’23 or so. So on the cash, side expect to pay, what less than – probably less than $10 million in ’23 for taxes. Hopefully, that helps.

Michael Polark: Yes, thank you.

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

Larry Biegelsen: Good afternoon, and thanks for taking the question. I guess I will take advantage of Rob’s presence and ask one more on reimbursement. So Rob, just if you meet the criteria for APC 5194, why is the potential timing gap that wasn’t clear to me. And just remind us of the percent of U.S. coronary that’s outpatient versus inpatient. I had one follow-up?

Rob Fletcher: Hi, Larry thanks for the question. Okay, so just take it in reverse order, PCIs between inpatient and outpatient, we generally have that at about 50-50. And I think as data emerges with the coding sets that are coming into fruition, we’ll be able to better answer the question and the future about how much that mix may be the same or different for coronary REL, but we don’t really have any reason to think it’s different — so that’s sort of your second part of your question, Larry, your first part, I believe, was related to the sort of timing gap. And yes, I think what happens is that transitional pass-through is on a calendar – quarterly calendar. And so we happen to have approved in the third quarter of 2021.

So that means it started on July 1. The program goes for three years. So it’s posted in sunset or and on June 30, 2024. That happens to be midyear. CMS typically wants to make their determinations on APC assignment via their annual rule-making process, which is allows for public comment and full sort of description of CMS’s analysis and thinking and reaction to that. They’d like to consider it very carefully. And so based on that calendar, that means that they would either have to address it in their proposed rules or final rules here in 2024 or 2025, since the program — the transitional program ends in the middle of the year. So that’s really the rub is will they address it in 2024 or 2025. We believe just based on the sort of stability and consistency of the data that likely whether they do an analysis now to make a determination for the 2024 rule, they’re doing a year, they’re going to come to the same conclusion and that is a pretty clear and compelling this needs to map to 5194.

So they’re going to do it anyway, we think. And so for the reasons kind of mentioned earlier, we believe that it’s more important to do it now that avoids any kind of potential disruption or confusion among hospitals and physicians. And the other thing I’d just offer up, Larry, is that this has been really a success story, we think, for ShockWave, but also for CMS, because this was kind of one of the first that I’m aware of anyway, the first breakthrough designated device to kind of go all the way through the process in interventional cardiology. And so here, this program within months of FDA approval, the transitional program was the pass-through program was initiated. It was terrific at doing this job of facilitating access to breakthrough therapy for medical for Medicare beneficiaries.

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