Beyond Air, Inc. (NASDAQ:XAIR) Q3 2024 Earnings Call Transcript

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Sam Eiber: Okay. Well understood. Thanks for taking the questions, Steve.

Steve Lisi: Great. Thanks. Appreciate it.

Operator: Our next question comes from the line of Matt Kaplan with Ladenburg Thalmann. Please proceed with your question.

Matt Kaplan: Hey, guys, thanks for taking the questions. Just wanted to — if you can give us a little bit more color on your — why you’re confident in your guidance in terms of the $12 million to $16 million for 2025? And what you need to see, I guess, in terms of conversions of some of these conversations that you’re having with different hospitals to achieve that?

Steve Lisi: Thanks, Matt. So look, you don’t win them all. There’s no way we expect about 1,000 here, but we do expect to be winning a good portion of these discussions that we’re having. What we need to see is keeping our existing customers, re-signing them because a lot of the re-signings are coming up in the next couple of months. I think that will be important. And it will also be important to bring on some new customers. What we need to see is June, July, August type things or where we believe we’ll be bringing on significant numbers of new customers because we’ll have already taken care of our existing customer base by every time we get out there, and we’ll have time to build up our inventory to a point where we can take on more hospitals.

So that’s what we need to see. And we’re already seeing it. We mentioned we had the new start, Feb 1. We had another start in February. So, it’s two hospitals starting in the month of February, and we’ll have more coming. I think we’re going to be seeing hospitals, hospital starts every month, multiple hospital starts every month, hopefully, and the sizes will vary. Some are small, some are medium, some are big. We might even get lucky, Matt, to get one of those giant-size customers. We’ll see. We’ll see if we can break into that club of having some of the big, huge users of nitric oxide in the United States.

Matt Kaplan: Okay. Great. That’s helpful. And then, in terms of the PMA supplement for cardiac surgery, obviously, the label and approval took a lot longer than you expected for initial indication. How is the review going? Is it just starting? And how do you expect it to progress? Is this something you expect to be completed later this year?

Steve Lisi: Matt, I don’t like to comment on things I have no control over. But I think before the end of this calendar year is a fair assessment that we’ll hear back from the FDA, one way or the other. It could be sooner than that. It could be the summer, it could be the fall. I mean it’s very difficult to pinpoint it. And I don’t want to give a hard date here. But I would say it’s going to take more than 180 days that some people may think. So, please don’t put 180 days. I don’t think we’re getting the approval in the month of May. I would think it’s going to take several months beyond that. And right now, it’s a pure guess on my part because the interactions with FDA, as you’re aware, we’re still a little bit short of when you would normally hear feedback from FDA.

We’re still a little bit of ways away from getting a full picture of FDA’s first pass of our application. So that’s just a guess on my part. We do feel confident in our application. We think that the data that have been generated are very strong. And we really look forward to discussing with FDA. I mean, my team can’t wait. We’re gearing up. We’re sitting here twiddling our thumbs, trying to prepare, guess what questions will be asked and try to be ready for it. That’s all we can do. So hopefully, next update in June I’ll have a little bit more information for you. But right now, it’s just our opinion.

Matt Kaplan: Great. All right. Well, thanks for taking the questions.

Steve Lisi: Perfect. Thanks, Matt. Appreciate it.

Operator: There are no further questions in the queue. I’d like to hand the call back to Steve Lisi for closing remarks.

Steve Lisi: Well, thanks, everyone, for tuning in. Much appreciated. We look forward to sharing with you our progress on the next call. Thank you.

Operator: Ladies and gentlemen, this does conclude today’s teleconference. Thank you for your participation. You may disconnect your lines at this time, and have a wonderful day.

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