Beyond Air Q3 2025 Earnings Call Transcript

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Operator

afternoon, and welcome everyone to the Beyond Air Financial Results Call for the Fiscal Quarter Ended 12/31/2024. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. And now, I'd like to turn the call over to Corey Davis, LifeSci Advisors. Thank you.

Operator

You may begin.

Corey Davis
Corey Davis
Investor Relations, LifeSci Advisors at Beyond Air

Thank you, operator. Good afternoon, everyone. Thank you for joining us. Today, after the market closed, we issued a press release announcing the operational highlights and financial results for Beyond Air's third quarter of fiscal twenty twenty five ended 12/31/2024. A copy of this press release can be found on our website beyondair.net under the News and Events section.

Corey Davis
Corey Davis
Investor Relations, LifeSci Advisors at Beyond Air

Before we begin, I would like to remind everyone that we will be making comments and various remarks about future expectations, plans and prospects, which constitute forward looking statements for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. Beyond Air cautions that these forward looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated. We encourage everyone to review the company's filings with the Securities and Exchange Commission, including without limitation, the company's most recent Form 10 ks and Form 10 Q, which identify specific factors that may cause actual results or events to differ materially from those described in the forward looking statements. Additionally, this conference call is being recorded and will be available for audio rebroadcast on our website, www.beyondair.net. Furthermore, the content of this conference call contains time sensitive information and is accurate only as of the date of this live broadcast, 02/10/2025.

Corey Davis
Corey Davis
Investor Relations, LifeSci Advisors at Beyond Air

Beyond Air undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call. With that, let me turn the call over to Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. Go ahead, Steve.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Thanks, Corey. Good afternoon to everyone joining us. With me here today is Doug Larson, our Chief Financial Officer. Let's start today's call by stating how pleased we are with the sequential quarterly revenue growth we are seeing as our commercial team continues to make significant progress. This has been driven by a steady stream of new hospital signings and going through the onboarding process to begin using our LungFit PH system in their institutions.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

During the quarter, we saw six new hospital starts and two hospitals renew their contracts, one of them for three years. There's only been about nine months since our upgraded LungFit PH began shipping and seven months since our new Chief Commercial Officer joined us, which has brought new energy to the entire Beyond Air team. We expect this momentum will continue and drive sequential quarterly revenue growth throughout this year. A key factor of our ongoing success is that the Beyond Air team has done a tremendous job of strengthening each stage of the customer engagement process to ensure we are offering the best possible experience for hospital administrators, nurses, physicians, staff and of course respiratory therapists. Most importantly, our existing customers are providing overwhelmingly positive feedback on the LungFit PH device, which translates to great references for potential new engagements.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Building on our robust customer engagement pipeline, we now have several partnerships in place supplementing our direct sales team, including HealthcareLinks, a renowned healthcare advisory and contracting firm that works with GPOs and IDNs and Trilimet to help us engage with and distribute to the military and veterans administration hospitals. Additionally, our marketing efforts have been upgraded significantly, which has provided a meaningful boost to our sales efforts. In addition, our presence and activities at all respiratory conferences are much improved, which you can see if you take a look at all of our social media postings. Turning to the PMA supplement for the LungFit pH label expansion to include cardiac surgery, the interactive discussion with FDA continues. We will continue to provide FDA with the information that they request and provide updates to investors each quarter.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

As a reminder, no nitric oxide products are currently approved for cardiac surgery in The United States. One last point about The U. S. Market. We expect our PMA supplement for our next generation lung fit PH transport capable system to be ready shortly for submission to FDA.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Recall that in November, we demonstrated this next generation system at the ARC Annual Meeting and the feedback was quite strong with the most common question being, when can I get this version of LungFit PH in my hospital? We will provide further details on this system on next quarter's earnings call. Outside The U. S, we announced in December that LungFit PH received the long awaited CE Mark approval. This approval allows us to market LungFit PH in the European Union as well as other countries that recognize this certification.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

The indications covered under CE Mark certification are the treatment of infants with greater than 34 gestation with hypoxic respiratory failure and the treatment of peri and post operative pulmonary hypertension in adults and children in conjunction with heart surgery. Receiving CE Mark triggered a $1,000,000 milestone payment from Getz Healthcare, our Asia Pacific distribution partner, which we will receive in the March. Along with royalty payments, we will receive based on lymphoid PH SaaS. Guess is already ahead of schedule securing market authorization in Australia less than two months after receiving CE Mark. To accelerate ex U.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

S. Sales, we have teamed up with business Asia Consultants to provide LungFit PH to hospitals throughout Europe, South America, the Asia Pacific region and The Middle East. We've already seen progress with extremely high distributor interest. And in fact, we already have two new contracts signed in The Middle East. As a reminder, the fact that LungFit PH generates nitric oxide from room air opens up enormous opportunity in areas around the world where hospitals are unable to obtain nitric oxide supply or do not use nitric oxide due to logistical difficulties associated with cumbersome cylinder based systems.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Overall, we believe that the updated lung fit PH on The U. S. Market since the spring of twenty twenty four is poised to start taking significant market share in The U. S. And globally.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

The inflection point is happening now in The U. S. Thanks to the system performance and our new and improved commercial infrastructure. Globally, we expect to see shipments starting in the next few months, which will make an impact on our revenues in the back half of fiscal twenty twenty six and beyond. We will be providing revenue guidance for fiscal twenty twenty six on our fiscal twenty twenty five year end conference call, which will be held in June.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Turning to Beyond Cancer, as peers reported, they received regulatory approval to begin a Phase 1b trial for low volume ultra high concentration nitric oxide or UNO in combination with anti PD-one therapy in late stage cancer patients who have failed anti PD-one therapy, which remains an area of high unmet patient need. Top line data from this Phase 1b study are anticipated around the end of calendar twenty twenty five. The UNO dose will be twenty five thousand parts per million. We call it low volume now because our original human study utilized one liter of gas, while this Phase 1b study will utilize less than 100 milliliters of gas, a reduction of over 90%. As everyone knows, the global anti PD-one therapy market is in the tens of billions of dollars.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

I encourage all of you to visit the Beyond Cancer website for more information as we believe this year should be transformational for this potentially groundbreaking therapy for those suffering from solid tumors. I am also pleased with the advances that Neurunos, our subsidiary focused on therapies for autism spectrum disorders is making. During the December, Neurunos announced the appointment of Professor Roger Kornberg to its Scientific Advisory Board. Doctor. Kornberg is renowned leader in the field of eukaryotic gene transcription and was awarded the Nobel Prize in Chemistry in 02/2006 for his groundbreaking work in molecular reality.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Neuronos will meet with FDA later this year to get an idea of the path to human studies, which we expect to begin in calendar twenty twenty six. The Neurons website offers a more complete understanding of what is to come over the next few years, including first in human data anticipated later in 2026. I hope you all see the great progress made recently and how these leading indicators paint a bright future for LungFit PH and for nitric oxide as a revolutionary therapy across multiple indications. Beyond our team will continue to be diligent on this path to profitability and improve the lives of patients in the need of the benefits of nitric oxide. Now, I will turn it over to our CFO, Doug Larson.

Douglas Larson
Douglas Larson
Chief Financial Officer at Beyond Air

Thanks, Steve, and good afternoon, everyone. Our financial results for the third quarter of fiscal twenty twenty five, which ended 12/31/2024, are as follows. Revenue for the fiscal third quarter of twenty twenty five were $1,100,000 as compared with $400,000 a year ago. We're showing a $200,000 loss in gross profit for the fiscal third quarter of twenty twenty five compared to a $400,000 loss for the same period last year. Cost of revenue in the current fiscal year exceeded revenue primarily due to $300,000 of one time costs required to upgrade our existing fleet of devices, but $500,000 of non cash headwinds, mainly the depreciation of devices purchased but not yet deployed.

Douglas Larson
Douglas Larson
Chief Financial Officer at Beyond Air

Research and development expenses were $3,000,000 as compared to $6,800,000 for the three months ended 12/31/2023. The decrease of $3,800,000 was primarily attributed to a decrease in salaries and stock based compensation. SG and A expenses for the three months ended 12/31/2024 and 12/31/2023 were $7,700,000 and $9,800,000 respectively. The decrease of $2,100,000 was attributed primarily to a decrease in salaries and stock based compensation costs. Other expense was $2,400,000 compared to $300,000 in the previous year.

Douglas Larson
Douglas Larson
Chief Financial Officer at Beyond Air

The increase of $2,100,000 was mostly non cash and attributed primarily to the extinguishment of the Avenue loan. Net loss attributed to common stockholders of Beyond Air Inc. Was $13,000,000 or a loss of $0.15 per share basic and diluted. Our net loss for the three months ended 12/31/2023 was $16,200,000 or a loss of $0.5 per share basic and diluted. Net cash burn in the quarter was $7,600,000 which was more than 30% lower than the prior quarter ended 09/30/2024.

Douglas Larson
Douglas Larson
Chief Financial Officer at Beyond Air

This decrease is mostly attributable to cost reductions implemented during the first half of fiscal year twenty twenty five, which included us closing two offices, a 30% reduction in staff, putting our VCAP study on hold and adjusting our production forecasts. We anticipate cash burn to continue the trend lower in the March, but not to the same magnitude as we saw in this quarter due to the one time costs required to complete the submission of our next generation LungFit pH to FDA. As of 12/31/2024, the company had cash, cash equivalents and marketable securities of $10,900,000 We believe that our cash, cash equivalents and marketable securities will be sufficient to allow us to support our current operating plans through the spring of twenty twenty six provided we continue to hit our internal revenue estimates and control costs at Beyond Air. With that, I'll hand the call back to Steve.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Thanks Doug. We will now take questions.

Operator

Great. Thank

Operator

you.

Operator

First question is from Jason Wits from Roth Partners. Please go ahead.

Jason Wittes
Managing Director & Senior Research Analyst at Roth Capital Partners, LLC

Hi. Thanks for taking the questions. It looks like nice progression this quarter. In terms of the CE mark, how does what should we think about in terms of timing in terms of how that might start impacting revenues going forward? Is that an initial immediate hit or is that a delay to get installations in or how do we think about that?

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Yes, thanks, Jason. Yes, it takes a little bit. So I wouldn't think we'd see much in this March that we're in. I would look more towards a small impact in the June and then picking up significantly in September and December and much more after that. So it would take a little bit to get going, but we're going to be shipping in the first half of this calendar year for sure.

Jason Wittes
Managing Director & Senior Research Analyst at Roth Capital Partners, LLC

Okay. That's good to know. And then in terms of expenses, from what you said, it sounds like for top expenses, specifically, I guess, everything except R and D, that should be coming down additionally this next quarter, right? I think you said there's an incrementally it will come down incrementally the next quarter, although it sounds like R and D is going out specifically because of the PMA. Did I understand that correctly in terms of how the fourth quarter looks and kind of what the trend might be in all these expenses?

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Yes, exactly. I mean, the June will be a much steeper drop than the March will be, because we're getting this second generation long fit pH submitted.

Jason Wittes
Managing Director & Senior Research Analyst at Roth Capital Partners, LLC

But the other expenses sound like there's still some additional incremental down on those expenses. I guess that's what I was asking as well.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Yes, correct.

Jason Wittes
Managing Director & Senior Research Analyst at Roth Capital Partners, LLC

Okay. And then maybe one last question or jump back in queue. In terms of the PMA submission, and this may be not an easy answer, but a sense of how long you expect that may take to run through the process, is that a I understand that it's always hard to get visibility on the FDA.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Especially now. I don't know how many people are going to be quitting the FDA and or taking retirement or what. We really just don't know. I guess we'll have a better idea once we submit. And as you know, there's usually a FDA acknowledges that receipt and send you out some questions and some thoughts and comments on your submission.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

So I think we kind of need to wait for that to get an idea of where FDA stands and what kind of resources they have to devote to this application. I don't even know if they know what their staff will look like in the next sixty days. So I really don't have an answer for you, Jason. I wish I did, but I just don't I don't know how to handicap it at this moment. I think things are still in flux over there.

Jason Wittes
Managing Director & Senior Research Analyst at Roth Capital Partners, LLC

Got it. That's very fair. I will jump back in queue. Thank you very much.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Thanks, Jason.

Operator

Next question is from Marie Thibault from BTIG. Please go ahead.

Sam Eiber
Vice President - Equity Research at BTIG

Hey, good afternoon. This is Sam on for Marie. Appreciate everyone taking the questions today. Maybe you could start here on the changes to the commercial organization. It's been about seven months since David joined.

Sam Eiber
Vice President - Equity Research at BTIG

You have the new LungFit system and clearly things are progressing in the right direction. So I guess I'm wondering what's working well, what are some of the changes that you've made internally that's driving some of this sequential strength here?

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

I think it's more of a cultural shift. I think David, who's our new Chief Commercial Officer, I don't want to call him new anymore. He's is no longer new. But so I think David's driven a new culture here. I think the culture was not good.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

When we launched the product, I think it was for various reasons and that culture needed to be changed. And I think David came in and created a new culture here and it's just a more positive attitude. And I think our customer service was always strong. I think it's gotten better. We have even new leadership on our customer service side.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Very excited about the gentleman who's running that now. And that makes a lot of difference when you're taking care of your customers, making sure that everything is running smoothly for them. And right now, the machine is performing beautifully. And our customer service team actually has a lot more time on their hands to work with our customers and potential new customers because they're not trying to keep up with the questions and issues that we had with the original version of the system, which was expected when the original version hit. It was absolutely expected.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Again, what wasn't expected is how long it would take us to get all those upgrades through FDA. But now that they're through, it's running as we expected. So I think the most important thing is the culture shift and our ability to have superior customer service than to what one might expect.

Sam Eiber
Vice President - Equity Research at BTIG

Yes, yes, it makes a lot of sense. And maybe just following up on the transport PMA submission, maybe I guess I'm wondering how material could that be once once you do get approval? How often is that coming up in your conversations with hospitals? And is that something where maybe the pipeline is already being built now so that once you do get the approval, you have customers basically waiting ready to sign up?

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Yes, I got to be careful how I answer this question for you. But yes, I think it comes up quite a bit about our next generation product. We showed it back in November. People have seen it. People are excited about it.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

They want it. And I do think it's going to make all the difference. It's not just transport capable, but there are other upgrades that have been made and it's a lot smaller and lighter. So that will help a lot as well. So people definitely want it and they're waiting for it, but I'm not going to go so far as to say we have a waiting list.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

I won't say that.

Sam Eiber
Vice President - Equity Research at BTIG

Okay. Okay. Very good. And maybe I can just squeeze in one final one in terms of annualized contract revenue. I think it was about 3,500,000 as of October.

Sam Eiber
Vice President - Equity Research at BTIG

Any update on that metric? Or is that something you're still providing?

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Looking at Doug right now, was it that high? We probably aren't going to comment on that. I guess the comment will be that I guess the Street's around $4,000,000 for our fiscal year of $25,000,000 and I think that's certainly a good place to be. As for what the run rate will be, I'll leave that to you. You saw what we put up this quarter.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

It's going to grow next quarter. Going to March will be higher than the December for sure. So you can kind of guess what that run rate will be.

Sam Eiber
Vice President - Equity Research at BTIG

Yes, it makes sense. Thanks for taking the questions.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Yes, thanks.

Operator

Next question is from Jason Bednar from Piper Sandler. Please go ahead.

Jason Bednar
Jason Bednar
Senior Research Analyst at Piper Sandler Companies

Hey guys, congrats on the quarter here and the progress. Steve, I'll start with one. I'm not sure you're going to be able to answer it or not, but I'll try. You say you're going to be reintroducing guidance, which is great to hear you got the visibility to do that when we get to that next quarter. You also sprinkled in like, hey, double digit sequential growth quarter on quarter going forward for the foreseeable future.

Jason Bednar
Jason Bednar
Senior Research Analyst at Piper Sandler Companies

And we can all see where The Street is at. I guess just as you try to maybe prep The Street investors, do you like where the Street is currently sitting for fiscal twenty twenty six? We're all kind of already modeling pretty strong double digit sequential growth quarter on quarter throughout the year. So is it would you say it's too strong? Would you like things to be more conservatively set?

Jason Bednar
Jason Bednar
Senior Research Analyst at Piper Sandler Companies

Any kind of thoughts or early thoughts there on the setup for the year?

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Well, thanks for bringing a smile to my face, Jason. We're definitely not going to comment. We'll give guidance in June for the fiscal year. And I am not going to give you any hints on what you should do with your numbers. You'll see what we report in June and I'll give you that guidance.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

So in general, we as a company internally, we feel really good about what we're doing right now. We feel really good about the progress we've made and the momentum we have. So I'll leave it at that.

Jason Bednar
Jason Bednar
Senior Research Analyst at Piper Sandler Companies

Okay. As we get as we kind of

Jason Bednar
Jason Bednar
Senior Research Analyst at Piper Sandler Companies

get closer and approach that point, do you think you'll be in a position to talk about the contribution you expect from U. S. Versus international partnerships? Or are you just thinking about, hey, here's our total worldwide revenue guidance and we'll leave it at that?

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

I think it's going to

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

be total because I think it's too early for us to gauge that ratio. International could move faster than we think. It could take a little longer than we think. We have a lots of countries to go through the regulatory process outside of the European Union. And as you know, inside the European Union, even though we have CE Mark, some countries are quicker than others in terms of getting your product to the market.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

So those are some of the things that are out of our control. So we just don't know how quickly it will happen. And again, even in The U. S, things can be a little chunky in terms of timing of when contracts start. So to really nail down that ratio between the two, I think that's going to be tough when we give guidance.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Maybe after a year of experience under our belt, we might be able to do a little bit better, but I think that's going to be tough. But the total number we'll be able to give ourselves some room on our total number with guidance, so that if there's movement between those two up or down in terms of expectations, we'll be perfectly fine to hit our guidance that we're going to give.

Jason Bednar
Jason Bednar
Senior Research Analyst at Piper Sandler Companies

Okay.

Jason Bednar
Jason Bednar
Senior Research Analyst at Piper Sandler Companies

As you give maybe a bit more rhythm in the business to and been more experienced now that you've been at the hospital contracting for a while, any seasonality that you're noticing on the contracting piece on when some of these contracts are coming up for bid, when hospitals are moving forward with decision making or is it are you not seeing any kind of notable seasonality to the business in the process?

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

I don't really think there's much seasonality to it. I don't really think there is. And again, it depends on some hospitals are larger than others. So you could get two or three hospitals in one quarter and have one big one and get seven the next quarter and those seven might not equal the big one. So it's pretty chunky at this point.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

And I think what we've seen is hospitals are starting every month of the year. We haven't really seen a major time point. And a lot of them, I don't want to give too much, but they don't have they can start some of the contracts, they can start when they want, right? They don't have to wait till the end of the contract, right? There are ways to move out of certain contracts.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

So if they want to move, they just say, hey, we want to move and they just go. So it just depends on the type of contract that they have. So I think it's very variable. I think it's when they make up their mind, they want to move, they'll move.

Jason Bednar
Jason Bednar
Senior Research Analyst at Piper Sandler Companies

Okay. That's all helpful. One last one to squeeze in and sorry if I missed it. Did you I know you were there was a prior question around the PMA submission for the next gen device. I don't think you commented on the status of the cardiac label expansion or indication in response to that question.

Jason Bednar
Jason Bednar
Senior Research Analyst at Piper Sandler Companies

Is there anything you can update on the status with the FDA questions you're receiving? Just how that's looking as you move forward in trying to secure that label?

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Yes. It's kind of the same thing I said about the PMA for the next gen system. I mean, we're certainly in contact with them about this, but it's a little bit in flux at the moment. We're kind of just kind of waiting for things to settle down a little bit with FDA and we'll keep working with them. But that's all I can say right now.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

I don't really have much detail to give on this other than that we're working with them and we'll continue to do so and push forward with this. I mean, this is an indication that obviously is approved everywhere in the world, but The United States. So I think for patients safety, this is something that should be late. Absolutely. So we'll keep working with the FDA and get them what they need.

Jason Bednar
Jason Bednar
Senior Research Analyst at Piper Sandler Companies

All right.

Jason Bednar
Jason Bednar
Senior Research Analyst at Piper Sandler Companies

Excellent. Thanks very much guys.

Operator

Next question is from Justin Walsh from Jones Trading. Please go ahead.

Justin Walsh
Director & Research Analyst at Jones Trading

Hi, thanks for taking the question. I'm wondering if you can remind us how you view the longer term relative importance of U. S. Versus ex U. S.

Justin Walsh
Director & Research Analyst at Jones Trading

Geographies for LungFit PH and maybe the expected impact in different geographies of the next generation product as that gets out there?

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Yes. I mean, you look out five years, I think ex U. S. Will be much bigger than The U. S.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Right now, it's not. But with our product, the fact that we're making it from ambient air, that changes the game. It's not easy for a lot of these countries to deal with cylinders or they may just be cost prohibitive or it's geographically prohibitive. And we solve that problem. I think that one example of that is the naval base in Guam.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

I think we're the only ones that could support them. It's that simple. So that will occur in our opinion all over the world where it's difficult to get nitric oxide. So that's going to take time. It's not going to happen overnight.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

It's not going to happen next year. But if you're looking out five years, I think ex U. S. Is going to be a lot bigger than The United States market in terms of money and total volume for sure. So we're very excited about the ex U.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

S. Opportunity. But again, that will take some time to roll out. So I don't see it impacting massively fiscal twenty twenty six or 2027 in a meaningful way where it's larger than The U. S.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Market. It will impact us in a meaningful way as a company, but it won't look bigger than The U. S. Market. I think that beyond that starting in which our fiscal twenty twenty eight, which will be mostly calendar twenty twenty seven, you'll start to see that trend moving.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

I think you'll start to realize, wow, the volume is picking up. Globally, this is going to be a much bigger product than anyone believes.

Justin Walsh
Director & Research Analyst at Jones Trading

Got it. Thanks for taking the question.

Operator

Next question comes from Yale Jen from Laidlaw and Company. Please go ahead.

Yale Jen
Senior Managing Director & Senior Biotech Analyst at Laidlaw & Company

Good afternoon and thank you for taking the question. And Steve, you mentioned you've got new six new hospitals and the two renews in The U. S. For this quarter. Is that right?

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

That's correct.

Yale Jen
Senior Managing Director & Senior Biotech Analyst at Laidlaw & Company

And last time you mentioned sort of that you got a previous quarter you got 60% increase in terms of hospital

Yale Jen
Senior Managing Director & Senior Biotech Analyst at Laidlaw & Company

contracts.

Yale Jen
Senior Managing Director & Senior Biotech Analyst at Laidlaw & Company

Would you be able to give any colors of that front? And then maybe one more question here is that for the last quarter's contract, any actually being becoming paying customers of this quarter?

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

So I don't have the numbers in front of me about the percentage increase like I did last quarter. My apologies. I can get that for you and get it to you offline.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

But I

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

didn't catch the last part of your question about paying customers. I'm sorry. What was that?

Yale Jen
Senior Managing Director & Senior Biotech Analyst at Laidlaw & Company

I mean, last quarter, you have a certain number of contracts assigned. Some of those contracts may not be paid immediately. In other words, purchased immediately. I'm just curious whether anything

Yale Jen
Senior Managing Director & Senior Biotech Analyst at Laidlaw & Company

some of those contracts of this quarter already become purchased on customers, so pay Yes.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

So you're right. So yes, we can sign a contract. The majority of contracts when you sign them, the customer starting like within thirty to forty five days with you. Some of them within fifteen days sometimes.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

But usually when they sign a contract, it's a start, I would say within sixty days or less usually. But every once in a while you have a hospital that assigns something three or six months in advance and say, hey, we're signing with you, start us in five months. So that does happen. So we did have a hospital, one or two, Doug, two hospitals in the March. No, no, no, they didn't start in December.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Starting in this quarter. Right. We actually had two hospitals that were signed in the summer that are starting in the March. But December was all signed and started right in the December. There were no longer term there were nobody signed in the December and didn't start in the December.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

But we had people over the summer who started in the September and they're starting in the March. That is true.

Yale Jen
Senior Managing Director & Senior Biotech Analyst at Laidlaw & Company

So in other words, the turnaround time becomes shortened and do you anticipate this sort of trend continues or this could be lumpy, varying, depends on the country?

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

No. Look, the two hospitals that signed six months in advance, that's rare. I mean, that's not normal, at least from what we've seen. Most of the hospitals are signing and starting up within thirty days, forty five days mostly. So I think that was just a little out of the ordinary.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

I'm not saying it's never going to happen, but it's rare, at least from what we've seen so far. Perhaps other companies in the space see it differently, but like I said, when a hospital wants to switch, they want to move, they move and they're done. So I think, yes, honestly, I think sometimes the hospital wants to go with us and they don't realize they can't get out of their contract, so they just sign with us and wait. I think that's what happened with these two hospitals. So So sometimes that happens.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

So I think it's more immediate.

Yale Jen
Senior Managing Director & Senior Biotech Analyst at Laidlaw & Company

Okay, great. I appreciate the colors on that. Maybe two quick questions. First one, in terms of balance sheet, as you look at that, you are totally out of the long term debt. Is that correct?

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

No, no. We remember last quarter, we swapped out the debt. So we have $11,500,000 dollars but the payments on that don't begin until October of twenty twenty six. So it gives us time before making payments on that. So the interest is accruing and going on top of the principal until we start making payments and that's an 8% royalty on net sales that pays that.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

So we don't have any scheduled payments. It's just at the end of the September quarter of '20 '6 of calendar twenty six that is, we will make a payment, it's thirty days later Doug or forty five days later? Thirty. Yes, thirty days later, we make a payment. So we start making those payments based on our ability to pay based on net sales.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

So that's the structure that structure is very company friendly, obviously.

Yale Jen
Senior Managing Director & Senior Biotech Analyst at Laidlaw & Company

Absolutely. And maybe the last question here is that you have this to transport a new, so next gen device. Let's just assume if for any reason that you may have your both NICU and cardiac PMA or supplement PMA approved, would you file for the next gen for both indications or you still start with the NICU and maybe later for the cardiac surgery once you have the supplemental MD or the regular system approved?

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

That's a pretty good question. I haven't really thought about that one. I don't I think this is a PMA supplement, right? So our next generation is a PMA supplement for our currently approved lung fit PH. So I think it would kind of just be automatic.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

I don't really know my regulatory will probably be mouth shut. But I think it's since it's a PMA supplement, our second generation for our first generation, we're just going to assume whatever the level is for the first generation.

Yale Jen
Senior Managing Director & Senior Biotech Analyst at Laidlaw & Company

I got you. Right, right, right. Just the improved promotion of it, I understand. Well, great. Thanks a lot.

Yale Jen
Senior Managing Director & Senior Biotech Analyst at Laidlaw & Company

Appreciate the colors and congrats on the good quarter.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Great. Thanks, Yale.

Operator

This concludes the question and answer session. I'd like to turn the floor back to management for any

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

questions. Thanks everybody for joining us. We are definitely looking forward to speaking with you in June and providing guidance for you. Thank you.

Operator

This concludes today's teleconference. You may disconnect your lines at this time. Thank you again for your participation.

Executives
    • Corey Davis
      Corey Davis
      Investor Relations, LifeSci Advisors
    • Steve Lisi
      Steve Lisi
      Chairman and CEO
    • Douglas Larson
      Douglas Larson
      Chief Financial Officer
Analysts
Earnings Conference Call
Beyond Air Q3 2025
00:00 / 00:00

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