Beyond Air Q4 2025 Earnings Call Transcript

Key Takeaways

  • 220% revenue growth to $3.7 M in FY 2025 and guidance of ≥$1.7 M for Q1 and $12 M–$16 M for FY 2026 underscores strong sales momentum.
  • Submitted a PMA supplement for LungFit PH2, featuring design enhancements like lighter weight and improved interface, aiming to expand market share pending FDA clearance.
  • Secured international distribution agreements in over ten countries covering 2 billion lives, with initial LungFit PH shipments and expected revenue contribution in H2 FY 2026.
  • Implemented a 58% reduction in operating expenses over six quarters and lowered net cash burn by 28%, extending cash runway into calendar 2026.
  • Partnered with Vanderbilt University Medical Center as the first luminary site to optimize LungFit PH deployment and support clinician training and references.
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Earnings Conference Call
Beyond Air Q4 2025
00:00 / 00:00

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Operator

Good afternoon, and welcome, everyone, to the Beyond Air Financial Results Call for the Fiscal Quarter and Year Ended 03/31/2025. At this time, participants are in a listen only mode. The question and answer session will follow the formal presentation. And now, I would like to turn the call over to Corey Davis with LifeSci Advisors. Please go ahead.

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

Thank you, operator. Good afternoon, everyone, and 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 fourth quarter of fiscal year twenty twenty five ended 03/31/2025. A copy of this press release can be found on our website beyondair.net under the news and events section. Before we begin, I'd 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.

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

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 SEC, 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, beyondair.net. Furthermore, the content of this conference call contains time sensitive information that is accurate only as of the date of the live broadcast, 06/17/2025. Beyond Air undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call.

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

With that, I'll 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, and good afternoon to everyone. With me here today is Doug Larson, our Chief Financial Officer. We are quite pleased with the progress we've made over the past year. For the fiscal year ended 03/31/2025, we reported a 220% increase in revenue to $3,700,000 compared with $1,200,000 for the same period last year. All of this growth came from US sales, the majority coming from hospitals signed during the back half of the year.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

As a result, we have tremendous revenue growth built in to kick off fiscal year twenty twenty six, along with several new growth drivers, as I will discuss in a moment. With this in mind, we have decided to also announce that we are on track to report revenue of at least $1,700,000 for the quarter ending in just two weeks on 06/30/2025, which translates to greater than a 45% sequential quarterly growth and greater than 145% year over year growth. In addition, are providing revenue guidance of 12,000,000 to $16,000,000 for the full fiscal year ending 03/31/2026. This level of projected growth moving forward shows how we are overcoming the barriers to entry in the nitric oxide market and are well on our way to making LungFit PH the market leader. The more customers use LungFit PH, the more confidence grows in the product and our ability to provide top tier service.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

This is an exciting time for our team and our shareholders. Let me now dig a little deeper into the numbers for the fiscal fourth quarter of twenty twenty five and growth drivers for fiscal twenty twenty six. The commercial team's efforts have led to a steady flow of new hospital contracts throughout fiscal year twenty twenty five. During the fourth quarter, we saw three new hospital starts and three hospitals renew their contracts. As I've mentioned recently, we have established a solid customer base across key target regions in The US.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

We are pleased and thankful that many of these customers have made themselves available as references for LungFit PH over recent months, which has proven to be a valuable tool when establishing new accounts. Further to the customer reference approach, we have partnered with Vanderbilt University Medical Center, naming them as the first luminary site for LungFit PH. Through this program, we will work alongside the Vanderbilt team to further optimize LungFit products and explore new opportunities to enhance hospital based nitric oxide therapy. In addition, Vanderbilt has made themselves available to better showcase the full utility of LungFit PH technology to respiratory therapists, anesthesiologists, nurses, and other relevant clinicians at hospitals considering adopting our cylinder free nitric oxide delivery system. This collaboration marks a major milestone in our core mission to redefine tankless nitric oxide delivery and drive continued innovation in respiratory care.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Now, I would like to update you on the status of LungFit PH2, our next generation system. As announced yesterday, we have submitted a PMA supplement to FDA. LungFit PH2 is smaller, lighter, and designed for air and ground transportation, while still delivering all the revolutionary features of the current FDA approved system. Additional improvements include a more intuitive user interface, more functional backup system, adjustable alarm volume, and significantly less frequent maintenance. All of these improvements were made with extensive input from our customers.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

We anticipate that the anticipated FDA approval of the second generation system and subsequent introduction to The US market will have a major impact on our market share, total No volume and logistics within the hospital. Looking outside The US, over the course of just the past six months, we have quickly ramped up our commercial program across Europe, Southeast Asia and The Middle East. These activities have included securing key regulatory approvals, including CE Mark, as well as signing distribution agreements across more than two dozen countries covering over 2,000,000,000 lives. Today, we announced that the team has recently signed several new international distribution partnerships for the following countries: India, Italy, Latvia, Lithuania, Estonia, Ukraine, Kuwait, Kazakhstan, Israel, and Poland. As a reminder, because the LungFit system generates No from Rumair, unlike other systems that require No filled cylinders, We are opening an enormous new opportunity in geographical areas around the world where hospitals are unable to obtain nitric oxide supply or do not use nitric oxide due to the logistical difficulties associated with cumbersome cylinder based systems.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

I am pleased to report that we have already shipped more than a dozen units of LungFit PH to customers outside The US over the course of just the past few weeks. As a result, we plan to see a meaningful contribution from these activities reflected in our financial results starting in the back half of fiscal twenty twenty six and beyond. Turning to Beyond Cancer, as previously reported, they received regulatory approval in Israel to begin a Phase Ib trial for low volume UNO, or ultra high concentration nitric oxide, in combination with anti PD-one therapy in late stage cancer patients who have failed anti PD-one therapy. This remains an area of high unmet patient need. Timing for the initiation of this study is under review.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Onto Neuronos, our subsidiary focused on therapies for autism spectrum disorders. We were pleased to announce recently that the US FDA granted orphan drug designation to our lead investigational therapy BA102, which is being developed for the treatment of Phelan McDermott syndrome, a syndrome associated with autism spectrum disorder. As many of you are aware, this designation provides key development incentives, including seven years of market exclusivity upon approval, tax credits for qualified clinical trials, waiver of FDA application fees, and access to FDA protocol assistance. Neuronos will meet with FDA later this year to get an idea of the path to human studies, which we expect to begin late in calendar twenty twenty six. The excitement around our autism program goes beyond our walls.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

This is evident by our ability to recruit leaders in the field to our scientific advisory board. Just recently, we announced the appointment of Nobel Prize Laureate Professor Dan Sheffman to the NeuroNOS SAB. We believe bringing in Professor Sheffman to join Professor Roger Kornberg from Stanford University on this board brings unparalleled scientific expertise to the NeuroNOS team. During the March, NeuroNOS published a peer reviewed journal article in translational psychiatry, which presented breakthrough research by its Chief Scientific Officer, Professor Haitha Mamal, which shows compelling evidence of a novel mechanism in the early stages of Alzheimer's disease. These new preclinical data further underscore the consistency and power of Neuronos' platform and offers new hope for the development of effective therapies for this devastating condition.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Building on the excitement around the data and progress of its programs, Neuronos announced at the March that it completed a $2,000,000 equity financing from private investors as part of a larger funding round. This investment will accelerate the preclinical development of Neuronos' small molecule drug, designed as an injectable or oral treatment for children with autism. Turning to the corporate side, we're excited to announce today the appointment of Bob Goodman to our board of directors, effective 06/13/2025. Bob is a seasoned healthcare executive and board director who brings decades of commercial leadership experience from across the medical technology, pharmaceutical services and medical device industries. His career has included executive roles at BioTelemetry, Philips Healthcare, CardioCore, Thermo Fisher and Pfizer.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Our board and management team look forward to working with Bob as we continue to build positive momentum across the commercial side of our business. Before I conclude my comments today, I want to mention that our LungFitGo program is still moving along. We are dedicated to bringing this therapy to market to improve the lives of patients suffering with lung infections. We plan to meet with FDA prior to year end to discuss the clinical path forward. We continue to make significant progress in executing against the strategies for each of our businesses.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Past year showed just a glimpse of how LungFit PH will transform the global No landscape for the better and gives us a solid foundation from which to continue to build. Beyond Air team will continue to be diligent on its path to profitability and improving the lives of patients in 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 fourth quarter fiscal year twenty twenty five, which ended 03/31/2025 are as follows. Revenue for the fiscal year ended 03/31/2025 increased 220% to $3,700,000 compared with $1,200,000 for the fiscal year ended 03/31/2024. We're showing $1,700,000 loss in gross profit for the fiscal year 2025 compared to $1,300,000 for fiscal year 2024. Cost of revenue of $5,400,000 were recognized in the fiscal year compared with 2,500,000 in the fiscal year ended 03/31/2024.

Douglas Larson
Douglas Larson
Chief Financial Officer at Beyond Air

Cost of revenue exceeded revenue primarily driven by the depreciation of LungFit devices and one time upgrade costs to systems. Research and development expenses were $16,900,000 for fiscal year 2025, compared with $24,400,000 for fiscal year ended 03/31/2024. The decrease of $7,500,000 was primarily attributed to a decrease in salaries, stock based compensation, and to a lesser extent from clinical and preclinical study expenses. SG and A expenses for the year ended 03/31/2025 and 03/31/2024 were $26,000,000 and $37,300,000 respectively. The decrease of $11,300,000 was attributed primarily to a reduction in salaries and stock based compensation costs.

Douglas Larson
Douglas Larson
Chief Financial Officer at Beyond Air

Other expense was $3,900,000 compared to $1,300,000 a year ago. The increase in other expense of $2,600,000 was mainly due to a non cash loss recorded upon the retirement of Avenue Capital debt. Net loss attributed to common stockholders of Beyond Air Inc. Was $46,600,000 or a loss of $0.69 per share basic and diluted. Our net loss for the fiscal year ended 03/31/2024 was $60,200,000 or a loss of $1.82 per share basic and diluted.

Douglas Larson
Douglas Larson
Chief Financial Officer at Beyond Air

Net cash burn for the year was $44,100,000 which is more than 28% lower than previous year. We've talked in previous quarters how we've been laser focused on fixed cost reduction in R and D and in our supply chain. Now that we're wrapping up spend on development of our next generation LungFit device, we'll see further reduction in our cash burn in Q1 and again in Q2. I would like to take a moment and expand a bit on our cost reduction efforts. Over the past six quarters, we've reduced operating expenses from north of $17,000,000 to just above $7,000,000 in the current quarter.

Douglas Larson
Douglas Larson
Chief Financial Officer at Beyond Air

This translates to a 58% reduction. We believe the trough in our operating expenses will either be in the coming June quarter or the September. Please do not interpret that expenses will be moving up significantly in the December. Expenses will move up in proportion to our commercial performance to maintain our excellence in service and take advantage of coming opportunities. As of 03/31/2025, the company had cash, cash equivalents and marketable securities of $6,900,000 Please note this does not include the $1,000,000 payment we received from GETS Healthcare, nor the additional $2,000,000 investment into our existing synthetic royalty debt structure, both of which we received after 03/31/2025.

Douglas Larson
Douglas Larson
Chief Financial Officer at Beyond Air

We believe our cash, cash equivalents, marketable securities, and existing financing vehicles will be sufficient to allow us to support our current operating plans well into calendar 2026 and potentially to profitability, provided we continue to hit our internal revenue estimates and control costs set beyond there. And with that, I'll hand the call back to Steve.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Thanks, Doug. We'll now take some questions. Operator?

Operator

Thank you. We'll now be conducting a question and answer session. Thank you. Our first question is from Marie Thibault with BTIG.

Marie Thibault
Managing Director at BTIG

Hi, good afternoon, and congrats on the progress here. I wanted to ask my first question here about LungFit two point zero. Great to see that get in. Wanted to understand if that system approval is being assumed in the fiscal year twenty six guidance range that you've given us and how we should think about the selling dynamics ahead of that potential approval. Is that something where hospitals see that coming approval and say, hey, I want to get exposure to LungFit before that comes out?

Marie Thibault
Managing Director at BTIG

Is it they wait a little bit as they're waiting for that NextGen system? Help us think about some of those dynamics.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Thanks, Marie. Fiscal twenty six guidance does not include the second generation system at all. And to answer your other question, you know, we we don't we don't promote the gen two, obviously, until we get approval. So people know it exists, obviously, and they and they do inquire. But I I think it's you know, the focus is on gen one.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

That's what we're promoting now, and that's what we're marketing and pushing. And, yeah, I mean, obviously, there are some hospitals that are interested in getting exposure to gen one immediately, and then there are others who will choose to wait. So we've seen both at this point.

Marie Thibault
Managing Director at BTIG

Okay, very encouraging. Very helpful, Steve. I wanted to ask also about OUS. You've gotten several shipments out there, it sounds like, of units. What are we understanding about what some of those contracts look like?

Marie Thibault
Managing Director at BTIG

Is there any difference in how hospitals use this versus how they use it within U. S. Hospitals? Any trends or specific countries we should be looking toward or any other catalyst OUS? Just wanna get a little closer to that market.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Yeah. I I I think it's a little early for us to see any trends in in actual hospitals outside The US. Right now, our shipments are initial shipments to distributors, and they're taking those and using them for demonstration to get interest to have hospital placements. And there's much more of a tender process outside The United States than in The US, so it takes a little bit longer to get into the hospitals. So I think the back half of this fiscal year, we'll see a big upswing on the international side as we get hospital placements, and we'll get some trends at that point.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

But our initial work in the market outside The US is showing consistency in terms of how they use nitric oxide. You know outside The US, cardiac surgery is on label. So they're definitely using it in that area. But again, similar to how it's used in The United States.

Marie Thibault
Managing Director at BTIG

Okay. Very helpful updates. Thanks a lot, Steve.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Thanks, Marie.

Operator

Thank you. Our next question is from Jason Witt with Roth Capital.

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

Hi. Thanks for taking the questions, and congrats on the progress here. On the PMA submission, do you have an expected timeline for when we may see an approval for for one FIT FAR two?

Douglas Larson
Douglas Larson
Chief Financial Officer at Beyond Air

Late timing.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Jason, did you did you ask me when FDA is gonna approve it?

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

I just do you have a estimate is what I'm asking? And I and I guess I was I'd add to that. How should we think about a potential launch? I think you had indicated earlier that it's kind of stage launch versus an immediate bolus type hit. I'm just curious about the dynamics around what we might expect when the FDA, approves this device.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Okay. So, yeah, I'm I'm gonna stay away from the exact timing on on an FDA approval. I mean, you you know, everybody kinda knows what's going on at FDA right now. There's a little bit of an upheaval. So let's just kinda let things settle in.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

It'll take a few months for us to interact with FDA and get a better understanding of of their questions on our on our application. And, you know, perhaps, you know, I can give some more more timelines or better better guidance on timing, at that moment in time. But as for the launch for Gen two, you know, obviously, we're we're we're gonna prep for that, as we we we work with FDA. There's always a a period where you need to build up inventory and you need to to scale up your manufacturing. So it will take a couple of months, and then we will try to keep up with demand.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

That'll that'll probably be the challenge that we have post approval.

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

Okay. That's fair. That's a totally appropriate answer. I get it. And then, you know, appreciate the guidance, which looks quite strong.

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

We're at the low end. There's a big range there. I mean, what what what what has to happen to get towards to the higher end of that range for the 12 to 16,000,000 that you're kind of hinting or pointing to for $20.26?

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Yeah. It's not really that big of a range. I mean, $4,000,000 range. I I guess it it seems that way because it's a small, you know, 12 to 16. It's not a 100 to a 104.

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

Percentage wise, certainly, but dollar wise, know.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

But, you know, I mean, you know, you you can get a couple of of of contracts that that are a good size, and they can move you a few million dollars. You know, we can get, you know, some some approvals, regulatory approvals overseas for some big countries and and and get some some big orders in. So, you know, it it it's not to us, it's not that big of a range, because things can swing dramatically with, some of the things that we have going on in the pipeline. So, you know, that that's kinda how we view it. We we we look at it as we feel pretty comfortable getting to the low end of that.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

There are there are a couple of things in the works that could get us into the middle and upper range of that. And, you know, if anything changes, we'll we'll update you. I mean, I know the next call we have is is in early August, so there might not be any kind of change at that point. But certainly by November, we'll have a good idea of of, how we're looking for getting into the range or, you know, perhaps, you know, maybe we get lucky. Maybe it'll it'll be at the high end or higher.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

We we just don't know at this point. There's there's too many moving parts, and it's only June. So it's it's exciting for us.

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

Got it. That's that's helpful. And then maybe just another clarification on did I hear correctly? So basically, on the expense line, there'll be further reductions until expected through September, then you basically grow with revenues on the expense line. Is that that the right way to think about modeling the P and L? Yes.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Exactly. Okay.

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

That's all I got. Thanks. And congrats on the PMA submission.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Thanks, Jason.

Operator

Our next question is from Justin Walsh with Jones Trading.

Justin Walsh
Director & Research Analyst at Jones Trading

Hi, thanks for taking the question. And now you guys are supplying globally. I was wondering, I guess, the degree to which you're seeing impacts or worried about impacts from some of the emerging geopolitical questions. I mean, we have a moving target with U. S.

Justin Walsh
Director & Research Analyst at Jones Trading

Tariffs and you mentioned that you're supplying to Ukraine and of course, have ties in Israel. So just curious how all of that is impacting things or not.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

You know, I I I don't think it's impacting us that much. I mean, we we manufacture in The United States for for LungFit. So the vast majority of our costs are are in The US. We do source some, some parts from, from outside The US, but, it it's not a major impact, if those tariffs and some of the big ones had are going to stay in place. It's a it's a low single digit percentage impact on our cost of goods.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

So it's not a major impact on us. And on the reverse side, we haven't really seen anything about where we're shipping to in terms of tariffs on the other end at this point. And as for Israel and Ukraine, I mean, honestly, it wasn't a you know, Israel's Israel's great to be in. It's not a large country, but it will impact our our our ex US sales. We're very happy to be there, but I don't think it's a major driver like a a France or a Turkey or an Australia, India.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

You know, these are much bigger countries where we are. And to be honest, we were we were very surprised and happy that the distributor, that we're working with in Eastern Europe, had Ukraine on their list. So we're very excited to to be able to help, the distributor there, go into Ukraine, but we didn't that that we didn't have any expectations for. So that's just that's just upside.

Justin Walsh
Director & Research Analyst at Jones Trading

Great. And maybe just a follow-up on that. I'm curious if you're seeing more uptake in some of those geographies or where you think some of the markets might be a little bigger. I mean, obviously, just mentioned a couple of them, but wondering if you're, I don't know, really think you'll take off in India or or somewhere in particular.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Yeah. I mean, it it it depends. Like, they're all different in terms of regulatory timing. So India, we have a partner, but there's there's a regulatory process to go through. So the impact from India on this fiscal year will be minimal.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

And, you know, some of the other countries where like Australia, Thailand, France, Romania, Turkey. These places, the regulatory process is already done or a very short time, so we'll get some more impact from them. But it's like I said earlier, an early question, it's a little too early because there are tender processes in a lot of these countries, so it takes time to get in to some hospitals. So we're gonna wait the next three, four, five months to see how those go and how many we get and how quickly we get in. And every country is different, so this is new for us as a company and new for this product, even our international team who has experience with this.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

This is a new product. I mean, no one's ever seen a noncylinder based nitric oxide system outside The United States before and, certainly not one that that makes it from ambient air. So this is kind of new for for everybody, and we have some distributors are extremely excited, jumped at the at at the opportunity, and it was very quick process to sign them up. And others are a little, you know, kinda more skeptical, I I think, because they they they can't believe the what the machine does. So I think we're just in the early stages, and it's exciting.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

And we'll we'll I'll probably have a better idea maybe on the next call or the call after that of to of of where we're gonna move quickly and which country is gonna move fastest. But right now, it's just, kinda feeling it out, and we're excited to have this many partners in this many countries open to us at this moment in time.

Justin Walsh
Director & Research Analyst at Jones Trading

Great. Thanks for taking the questions.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Thanks, Justin.

Operator

Our next question is from Yale Jen with Laidlaw and Company.

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

Good afternoon, and thanks for taking the questions, and congrats on the guidance as well as the performance. We just got about three here. The first one is that you suggest that you will have more than 1,700,000.0 for the next quarter, or current ongoing quarters, actually, and, 12 to 16 for the fiscal twenty sixth. So what are so what's the confidence, you can, you know, provide that behind these, forecast or projections? And I have a follow-up.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Thanks, Yale. I mean, we're we're pretty confident. We wouldn't have put it out if we weren't. I I think the fact that the June ends in two weeks, we're we're pretty confident it'll be 1,700,000. You know, there could be something that happens in the next two weeks to bump it up a bit.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

We can't really predict that, but we're highly confident in that number. And as for the, you know, the fiscal year, we're pretty confident. I mean, we've got a lot in the hopper here, especially on the international side. Even in the in The US, there's there's movement in in some areas that, you know, we're we're we're excited to see and maybe happening a little bit sooner than we thought. So I'll give you an example.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

You know, we we have we're we're very flexible with the customers in how they wanna structure their contracts. It's very easy with our system to be as as flexible as as as they would like us to be. But one of the things we started offering earlier this year is is is the razor razor blade model. So the purchase of our system and then the ongoing purchase of the consumables, which is mainly the filter. And we've gotten some some good feedback over the last month or two on that model.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

So we may actually see, some hospitals jumping at the opportunity for for that rather than, the more traditional nitric oxide model, which is how many hours you use x amount. This is what your annual cost could be divided by 12, and you get paid that per month. That's really the main way it's done, but we're offering this other way of doing it with the purchase model. And, you know, we we we may see some of that in this fiscal year, and that that's exciting. And that gives us some confidence in our numbers, because it wasn't something we were we were seeing six to nine months ago at all.

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

Okay. Great. That's very helpful and confident comforting. And, also, in the press release, you mentioned you have about 45 hospitals in The United States now either installed or actually as well as using the long distance. And so going toward, let's say, end of this year, fiscal year, so maybe the or calendar years of this end of this year, Do you anticipate what might be the estimate or projection of the number of hospitals that you may have, as well as maybe whether you also see the volume increase per hospital?

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Yeah. I I definitely see the volume increasing per hospital. We've been seeing that, for the past year and a half. A lot of our hospitals are going over what their estimate was for the for the for the year. That's a good thing.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

You know, we do we do offer discounted hourly rate if they go over. So certainty of price, is important for the customer. So, I think that may continue. Hopefully, hospitals can get a you know, work with us and get a better handle on what they're gonna use for the year, so there's certainty in what they're spending. I I don't wanna speculate on the total number of hospitals we're going to have at the end of the fiscal year.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

While it's important, while while it's important, you know, not every hospital is created equal. So some hospitals are are are small in terms of their volume, and some are very large in terms of their volume. So we could have one hospital be worth 10 in some cases. So, obviously, 45 is a great number. I certainly see it being significantly more than that number at the end of the fiscal year, but I'm gonna I'm not gonna gonna take a guess and try to triangulate that exact number right now, Yale. But thank you.

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

Okay. Great. And maybe just squeeze in one more question to actually follow-up the earliest earlier one. That for the PMA applications, I know this is difficult to predict the time in possible approval, for a possible approval. But just let's assume, or maybe if in the normal, quote unquote, normal circumstances, would this process maybe take, what, twelve months or sixteen months or or shorter?

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

Just curious what what would be the sort of reference point we can at least think about? And thanks.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Yeah. So so there there there are statistics that FDA puts out about PMAs and PM this is a PMA supplement. So FDA puts statistics out about how long these things take so you you can see them online. I I I just caution you to take these averages because not every PMA is created equal. You know, we are just a supplement.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

You know, we've we basically make nitric oxide the same way as our with our second generation system as our first generation system. A lot of the the things that we do are are are equivalent. It's obviously smaller. It it it obviously has some some enhanced features, and it obviously is is built to be used for transport in ambulances and helicopters and and airplanes. So there are some differences, but from how it operates, it's really not that much different.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

So, could we be quicker than the average that FDA puts out? Probably. But again, if you look at FDA's guidelines, it's one hundred and eighty days for a PMA supplement and they normally do not hit that one hundred and eighty days. And it's not that they can't hit their timelines. A lot of times they have questions and that clock will stop while you're having discussions with FDA.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

So that's something that companies don't control, FDA does, and we're gonna work with them to get this done as quickly as possible. But I just don't know what that timeline will be at this point. We'll have a better handle once we start discussions with FDA in the next couple of months.

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

Great. That's a lot of great colors on the story. And, again, congrats, and thanks for taking the question.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Thanks, Jim.

Operator

Our next question is from Jason Bednar with Piper Sandler.

Joseph Downing
Joseph Downing
AVP - Equity Research at Piper Sandler Companies

Hey, guys. Thanks for taking the question. This is Joe Downing on for Jason. Congrats on the PMA submission. Just wondering if there's any difference you can call out in the sales process with the two point zero device versus the one point zero device.

Joseph Downing
Joseph Downing
AVP - Equity Research at Piper Sandler Companies

And then just off of that, can you just remind us how much this LungFit two point zero expands the market?

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

So, Joe, thanks for the questions. I mean, we're not trying to sell this Gen two or market the Gen two right now, so we're not going to comment on how the process is different because we don't have a process yet. We have to wait for approval on that. But as for how it opens the market, I mean, it it it vastly expands this market. It opens it up for us as a company to every hospital in the world, that wants to use nitric oxide.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

We can get it anywhere. Our Gen one is already in remote locations treating patients, so the Gen two, it'll be even easier to do that. So this is something that will change the way people use nitric oxide in the hospital. I think that it will increase volumes overall, and again, reach hospitals that don't use nitric right now. So this is, for us, I think, and for the industry, it's a game changer. It really is.

Joseph Downing
Joseph Downing
AVP - Equity Research at Piper Sandler Companies

Great. Thanks, Steve. Appreciate that. And then just one last one on the competitive landscape. Your largest peer put out a new offering a number of months ago.

Joseph Downing
Joseph Downing
AVP - Equity Research at Piper Sandler Companies

Just wondering if you're seeing anything worth calling out with contract negotiations with hospitals as a result of that of that launch.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Which which one are you talking about?

Joseph Downing
Joseph Downing
AVP - Equity Research at Piper Sandler Companies

Mallinckrodt.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Oh, there oh, the Mallinckrodt offering?

Joseph Downing
Joseph Downing
AVP - Equity Research at Piper Sandler Companies

Yeah.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Yeah.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

You know, we haven't seen a change. I mean, the the contracts are usually one, three, and five years in this market. We haven't really seen any change in that. So at least my team and I haven't really seen much change. Yes, they're out there with their new offering, and they're marketing it for sure.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

And I think last time they spoke, gave an idea of how many hospitals they were in or something, whether they were in hospitals, so you can take a look at what their transcript said. So yeah, it's another competitor. It's another cylinder based system out there. That's the fourth cylinder based system in The United States.

Joseph Downing
Joseph Downing
AVP - Equity Research at Piper Sandler Companies

Great. Thanks, Steve. Appreciate it.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Yep. Thanks, Joe.

Operator

At this time, we are showing no further questions in queue. This does conclude our question and answer session. I would now like to turn the call back over to Steve Lisi for any closing remarks.

Steve Lisi
Steve Lisi
Chairman and CEO at Beyond Air

Just like to thank everybody for joining us today, and we'll talk to you in August. Thank you.

Operator

This concludes today's conference. You may disconnect your lines at this time. Thank you 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