Beyond Air Inc (XAIR) 2025 Q3 法說會逐字稿

Good afternoon, and welcome, everyone, to the Beyond Air financial results call for the fiscal quarter ended December 31, 2024. (Operator Instructions) And now I'd like to turn the call over to Corey Davis, Lifesci Advisors. Thank you. You may begin.

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 2025 ended December 31, 2024. A copy of this press release can be found on our website, beyondair.net, under the News & Events section.

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-K 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 that is accurate only as of the date of this live broadcast, February 10, 2025. 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.

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.

During the quarter, we saw six new hospital starts and two hospitals renew their contracts, one of them for three years. It's only been about ine 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.

Building on our robust customer engagement pipeline, we now have several partnerships in place, supplementing our direct sales team, including Healthcare Links, a renowned health care advisory and contracting firm that works with GPOs and IDNs, and TrillaMed 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. As a reminder, no nitric oxide products are currently approved for cardiac surgery in the United States. One last point about the US.

market. We expect our PMA supplement for our next-generation LungFit PH transport capable system to be ready shortly for submission to FDA. Recall that in November, we demonstrated this next-generation system at the AARC 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 US, 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. The indications covered under CE Mark certification are the treatment of infants with greater than 34 weeks 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 million milestone payment from Getz Healthcare, our Asia Pacific distribution partner, which we will receive in the March quarter, along with royalty payments we will receive based on LungFit PH sales. Getz is already ahead of schedule securing market authorization in Australia, less than two months after receiving CE Mark.

To accelerate ex US 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 have 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 natural oxide supply or do not use nitric oxide due to logistical difficulties associated with cumbersome cylinder-based systems. Overall, we believe that the updated LungFit PH on the US market since the spring of 2024 is poised to start taking significant market share in the US and globally. The inflection point is happening now in the US, 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 2026 and beyond. We will be providing revenue guidance for fiscal 2026 on our fiscal 2025 year-end conference call, which will be held in June.

Turning to Beyond Cancer. As previously reported, they received regulatory approval to begin a Phase Ib trial for low-volume ultra-high concentration nitric oxide, or UNO, in combination with anti-PD-1 therapy in late-stage cancer patients who have failed anti-PD-1 therapy, which remains an area of high unmet patient need. Top line data from this Phase Ib study are anticipated around the end of calendar 2025. The UNO dose will be 25,000 parts per million. We call it low volume now because our original human study utilized 1 liter of gas, while this Phase Ib study will utilize less than 100 milliliters of gas, a reduction of over 90%.

As everyone knows, the global anti-PD-1 therapy market is in the tens of billions of dollars. 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 NeuroNOS, our subsidiary focused on therapies for autism spectrum disorders, is making. During the December quarter, NeuroNOS announced the appointment of Professor Roger Kornberg to its Scientific Advisory Board. Dr. Kornberg is a renowned leader in the field of eukaryotic gene transcription and was awarded the Nobel Prize in Chemistry in 2006 for his groundbreaking work in molecular biology. 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 2026.

The NeuroNOS 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 Air 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.

Thanks, Steve, and good afternoon, everyone. Our financial results for the third quarter of fiscal 2025, which ended December 31, 2024, are as follows. Revenue for the fiscal third quarter of 2025 were $1.1 million as compared with $0.4 million a year ago. We're showing a $0.2 million loss in gross profit for the fiscal third quarter of 2025 compared to a $0.4 million loss for the same period last year.

Cost of revenue in the current fiscal year exceeded revenue primarily due to $0.3 million of onetime costs required to upgrade our existing fleet of devices plus $0.5 million of noncash headwinds, mainly the depreciation of devices purchased but not yet deployed. Research and development expenses were $3 million as compared to $6.8 million for the three months ended December 31, 2023. The decrease of $3.8 million was primarily attributed to a decrease in salaries and stock-based compensation. SG&A expenses for the three months ended December 31, 2024, and December 31, 2023, were $7.7 million and $9.8 million, respectively. The decrease of $2.1 million was attributed primarily to a decrease in salaries and stock-based compensation costs.

Other expense was $2.4 million compared to $0.3 million in the previous year. The increase of $2.1 million was mostly noncash and attributed primarily to the extinguishment of the Avenue loan. Net loss attributed to common stockholders of Beyond Air, Inc. was $13 million or a loss of $0.15 per share, basic and diluted. Our net loss for the three months ended December 31, 2023, was $16.2 million or a loss of $0.50 per share, basic and diluted.

Net cash burn in the quarter was $7.6 million, which was more than 30% lower than the prior quarter ended September 30, 2024. This decrease is mostly attributable to cost reductions implemented during the first half of fiscal year 2025, 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 quarter but not to the same magnitude as we saw in this quarter due to the onetime costs required to complete the submission of our next-generation LungFit PH to FDA.

As of December 31, 2024, the company had cash, cash equivalents and marketable securities of $10.9 million. 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 2026 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.

Thanks, Doug. We will now take questions.

(Operator Instructions) Jason Wittes, ROTH Partners.

Hi, thanks for taking the questions. 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?

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

Okay. That's good to know. And then in terms of expenses, from what you said, it sounds like for op expenses, specifically, I guess everything except R&D, that should be coming down additionally this next quarter, right? I think you said there's an incrementally -- it has come down incrementally in the next quarter, although it sounds like R&D is going up 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?

Yes. Exactly. I mean the June quarter will be a much steeper drop than the March quarter will be because we're getting this second-generation LungFit PH submitted.

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

Yes. Correct.

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

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 -- FDA acknowledges that receipt and sends you out some questions and some thoughts and comments on your submission.

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 60 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.

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

Thanks, Jason

Marie Thibault, BTIG.

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

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 no longer new. But -- so I think David has driven a new culture here. I think the culture was not good 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 is always strong. I think it's gotten better. We have even new leadership on our customer service side. 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 in 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.

Again, what wasn't expected is how long it would take us to get all those upgrades through FDA. But now 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.

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 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?

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. 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. I won't say that.

Okay. Very good. And maybe I can just squeeze in one final one in terms of annualized contract revenue. I think it was about $3.5 million as of October. Any update on that metric? Or is that something you're still providing?

I'm 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 is around $4 million for our fiscal year of '25. 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. It's going to grow next quarter or the March quarter will be higher than the December quarter for sure. So you can kind of guess what that run rate will be.

Thanks for taking the questions.

Yes, thanks.

Jason Bednar, Piper Sandler.

Hey guys. Congrats on the quarter here and the progress. Steve, I'll start with one. I'm not sure you're going to -- you'll be able to answer it or not, but I'll try. You said 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. And we can all see where the Street is at.

I guess just as you try to maybe prep the Street and investors, do you like where the Street is currently sitting for fiscal '26? 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? Any kind of thoughts or early thoughts there on the setup for the year?

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. 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.

Okay. As we get -- as we kind of get closer and approach that point, do you think you'll be in a position to talk about the contribution you expect from US versus international partnerships? Or are you just thinking about, hey, here's our total worldwide revenue guidance and we'll leave it at that?

I think it's going to 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 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, this -- some countries are quicker than others in terms of getting your product to the market.

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 US, 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. 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.

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

I don't really think there's much seasonality to it. I don't really think there is. And again, it's -- 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 just -- it's pretty chunky at this point. 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, they -- 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 until the end of the contract. There are ways to move out of certain contracts. 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.

Okay. All right. 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 that in response to that question. 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?

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 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.

I won't -- 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 -- patient safety, this is something that should be labeled. Absolutely. So we'll keep working with the FDA and get them what they need.

Alright excellent thanks very much guys.

Justin Walsh, 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 US versus ex US geographies for LungFit PH and maybe the expected impact in different geographies of the next-generation product as that gets out there.

Yes. I mean if you look out five years, I think ex US would be much bigger than the US Right now, it's not. But with our product, the fact that we're making it from ambient air, it 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. 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. It's not going to happen next year. But if you're looking out five years, I think ex US 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 US opportunity. But again, that will take some time to roll out. So I don't see it impacting massively fiscal '26 or '27 in a meaningful way where it's larger than the US market.

It will impact us in a meaningful way as a company, but it won't look bigger than the US market. I think that beyond that, starting in which -- our fiscal '28, which would be mostly calendar '27, you'll start to see that trend moving. 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.

Got it thanks for taking.

Yale Jen, Laidlaw & Company.

Good afternoon and thanks for taking the question. And Steve, you mentioned you've got new -- six new hospitals and two renews in the US for this quarter. Is that right?

That's correct.

And last time you mentioned sort of that you got -- previous quarter, you got a 60% increase in terms of the hospital contracts. Would you be able to give any color on 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?

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

I mean last quarter, you have a certain number of contracts signed. Some of those contracts may not be paid immediately. In other words, purchase immediately. I'm just curious whether anything -- some of those contracts of this quarter already become purchasing customers or paid customers.

You're right. Yes. So yes, we can sign a contract. The majority of contracts when you sign them, the customers starting like within 30 to 45 days with you. Some of them within 15 days sometimes.

But usually when they sign a contract, it's a start, I would say, within 60 days or less, usually. But every once in a while, you have a hospital that signs 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 quarter -- no, they didn't start in December. Right. We actually had two hospitals that were signed in the summer that are starting in the March quarter. But December, it was all signed and started right in the December quarter.

There were no longer term -- there were -- nobody signed in the December quarter and didn't start in the December quarter. But we had people over the summer who started in the September quarter and they're starting in the March quarter. That is true.

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 contract?

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 30 days, 45 days, mostly. So I think that was just a little out of the ordinary. 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 -- honestly, I think sometimes a hospital wants to go with us and they don't realize they can't get out of their contract so they just signed with us and wait. I think that's what happened with these two hospitals. So sometimes that happens. So I think it's more --

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

No, no. We -- remember, last quarter, we swapped out the debt. So we have $11.5 million, but the payments on that don't begin until October of '26. 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.

So we don't have any scheduled payments. It's just at the end of the September quarter of '26 -- of calendar '26, that is, we will make a payment. Is it 30 days later, Doug, or 45 days later?

30.

Yes, 30 days later. We make a payment. So we start making those payments based on our ability to pay based on net sales. So that's -- that debt structure is very company-friendly obviously.

Absolutely. And maybe the last question here is that you have this plan for new sort of next-gen device. Let's just assume if for any reason that you may have both NICU and cardiac PMA or supplement PMA approved. Would you file for the next gen for both indications? Or you still start with NICU and maybe later for the cardiac surgery once you have the supplement NDA for the regular system approved?

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 LungFit PH. So I think it would kind of just be automatic. I don't really know my regulatory -- I should probably keep mouth shut. But I think it -- since it's a PMA supplement, our second generation for our first generation, we're just going to assume whatever the list is for the first generation.

I got you. Right, right, right. Improved version of it. I understand. Well, great. Thanks a lot. I appreciate the colors and congrats on the good quarter.

Great, thanks you.

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

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

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