Beyond Air, Inc. (XAIR) Earnings Call Transcript & Summary

Good morning, everyone, and welcome to the Beyond Air Financial Results Call for fiscal year ended March 31st, 2026. 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 Garth Russell with LifeSci Advisors.

Thank you, Operator. Good morning, everyone, and thank you for joining us. Earlier today, we issued a press release announcing the operational highlights and financial results for Beyond Air's fiscal year ended March 31st, 2026. A copy of this press release can be found on our website, www.beyondair.net, under the News and Events section. Before we begin, I would like everyone that we will be making comments and various remarks about the 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 actual results to differ materially from those indicated. We encourage everyone to review the company's filings with the Securing Exchange Commission, including, without limitation, the company's most recent Form 10-K and Form 10-Q, which identifies 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 the live broadcast, June 26, 2026. Beyond Air undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call. With that, I'll now turn the call over to Robert Goodman, Chief Executive Officer of Beyond Air. Bob, the floor is yours.

Thanks, Garth, and good morning to everyone. Also here with me today is Dan Moorhead, our Chief Financial Officer. This is my first earnings call as Chief Executive Officer, and I'm excited to lead beyond here during what I believe is a pivotal moment for the company. the last several months, I've spent a lot of time with our customers, commercial organization, distribution partners, and board, and those discussions have only strengthened my conviction that 1-PH represents a significant commercial opportunity to establish Beyond Air as a leader in the nitric oxide market. As a leadership team, we've become increasingly focused on aligning our commercial strategy, R&D efforts, and operating expenses across our core business. particularly as we move closer to regulatory approval of our second generation One Fit system. The strategic focus is reflected in what we believe is an important flexion point for the business in the near term. With our Gen 2 system, if approved, we expect to be more competitive and offer a more attractive solution for a broader range of hospital systems with external transport needs. As a result, we see the potential to immediately expand our total addressable market to over $1 billion globally. Accordingly, our strategy is very straightforward. We are allocating our resources with discipline towards the opportunities we believe can create the greatest near and long-term value, including adoption of our current Commercial One Fit system and preparing for the launch of our Gen 2 system. Fiscal 2026 displayed meaningful progress toward this goal. Revenue increased more than 107% year-over-year to $7.7 million in the currently smaller addressable market, driven by strong retention among our existing customer base and continued new hospital adoption. Importantly, our customer renewal rate was approximately 90%, which reflects the value LungFit PH is delivering in clinical practice and the confidence our customers have in our technology and operational service support. This high level of customer satisfaction should be directly transposable to the Gen 2 device, and we continue to receive consistent feedback from our potential future customers that they're waiting for our next generation platform to help meet all of their comprehensive I&O requirements, including their transport needs. As a reminder, the current label for the Lung Fit PH does not include transport use outside of the hospital. If approved, the Gen 2 product is intended to address the limitations through a broader label that would include transport use. We believe this will increase the total U.S. addressable market approximately fourfold to approximately $400 million and expand the worldwide opportunity to more than $1 billion. We've made meaningful progress expanding our commercial reach. We recently announced a national purchasing agreement with one of the top three U.S. group purchasing organizations for inhaled nitric oxide therapy. This marks the third major GPO to engage beyond air and represent another important milestone in expanding access to 1-fit pH across the U.S. Combined with our existing agreements with Premier and Vizient, we now have access to a substantial portion of the U.S. market. We believe these relationships provide an important foundation for continued adoption and growth in the years ahead. Additionally, we continued to broaden our global distribution network throughout the year and we now have regulatory clearance in over 45 countries. While we remain in the early stages of international commercialization, we believe the growing network provides a significant opportunity for future revenue. As it relates to our Gen 2 Lung Fit pH system, which is under review at the FDA, we believe this to be the most important near-term catalyst for the company. As many of you know, we submitted our PMA supplement to the FDA in June of 2025 and continue to work through the review process at the expected pace. Based on our interactions with the FDA and the progress of the review process to date, we continue to believe we are on track for potential approval in the second half of the calendar year, although the timing and outcome of the review remains subject to the FDA's discretion. Accordingly, we continue to prepare for a potential commercial launch by the end of the year 2026. We continue to hear from prospective customers that the anticipated features of the Gen2 platform, including a smaller footprint, reduced weight, simplified operation, longer service intervals, and ground and air transport availability, may address needs that are not fully met by currently available alternatives. The result, we believe the Gen2 platform could represent an attractive option for certain institutions if approved. terms of the other programs outside of our core at OneFit PH business, we're taking a disciplined and focused approach to capital allocation. Our priority is clear. The Beyond Air team and its resources are focused on the success and growth of the commercial activities around the OneFitPH system, and we will continue to allocate our resources almost exclusively to the OneFitPH system. I believe we're currently operating with a greater focus, stronger commercial momentum, and a clearer path forward. We have expanded market access through leading GPO relationships, strengthened our international footprint, and continue to prepare what will be a transformational Gen 2 launch, if approved. We believe the strategy The strategy I've discussed today establishes a clear roadmap for continued growth. With fiscal 26 complete, we're transitioning from a March 31 to December 31 year end and begin operating on a calendar year end. As a result, we're providing revenue guidance for the first time for calendar year 2026 of $8 million. That equates to approximately 15% growth over calendar year 2025. Our first-time guidance for calendar year 2027 is 16 to 18 million, which would represent over 110% year-over-year growth at the midpoint of that range. It assumes FDA approval and commercial launch of the Gen 2 system during 2027 in accordance with our current planning assumptions. Between expanding market access, growing customer adoption, international expansion, and anticipated launch of Gen2, we believe the company is entering an important new phase of commercial execution and an imminent inflection point for revenue growth. Before I conclude my prepared remarks, I want to recognize the entire Beyond Air team. Over the past several months, I've had the opportunity to work closely with employees across the organization and have seen firsthand the dedication, expertise, and commitment they bring to the mission. With that, I'd like to thank all of you for your time and attention. that, I'll turn the call over to Dan for review of the financial results. Dan?.

Thanks, Bob, and good morning, everyone. I'll walk through our full-year financial results for the fiscal year 2026, which ended March 31, 2026. Revenues for the fiscal year ended March 31, 2026 increased 107% to $7.7 million compared with $3.7 million for fiscal year 2025. This growth was driven by increased demand for LungFit pH in both US and international markets. Gross profit for fiscal year 2026 improved $300,000 compared with the loss of 1.7 million in the prior year. This represents a $2 million swing to profitability, which is a meaningful milestone for the company and reflects the operating leverage we are beginning to see as revenue scales. Turning to operating expenses, R&D expenses for fiscal year 2026 decreased 39% to $10.2 million, compared with $16.9 million for fiscal year 2025. The reduction was primarily driven by decreased employee expenses as a result of prior restructuring activities and lower development costs associated with our Gen 2 device and PMA supplement, which was submitted to the FDA in June 2025. SG&A expenses for fiscal year 2026 were $19.1 million, compared with $26 million for fiscal year 2025, a decrease of 27% for approximately $7 million. The reduction was primarily driven by lower employee-related costs as a result of prior restructuring initiatives. In total, we reduced our cost structure significantly year over year, which in combination with revenue growth drove a 35% or $15.5 million improvement in operating results. Other expense for fiscal year 2026 was $5.3 million, compared with $3.9 million for fiscal year 2025. Net loss attributable to common stockholders of Beyond Air for fiscal year 2026 was $33.2 million, or a loss of $4.01 per basic and diluted share, compared with $46.6 million, cents per share for fiscal year 2025. Net cash burn excluding inflows from financing activities for fiscal year 2026 was $19.1 million, down 56% compared to fiscal year 2025. As of March 31, 2026, we reported cash, cash equivalents, restricted cash, and marketable securities of $17.3 million. Total long-term debt outstanding was $21.6 million.

With that, I'll hand the call back to Bob. Thanks, Dan. Before we open the call for questions, I want to briefly address our NASDAQ listing. Earlier this month, we announced that the NASDAQ hearings panel granted our request to continue listing on the NASDAQ stock market, subject to our regaining compliance with NASDAQ's minimum bid price requirement by July 31, 2026. Long stockholder approval at the special meeting held on June 18th, our board approved a 1 for 20 reverse split. As a result, we expect the reverse split positions the company to regain compliance with the bid requirement by July 31st deadline. With that, we now open the call for questions. Thank you.

If you'd like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star 1 button. our case. Our first question comes from the line of Yale Jen with Laidlaw and Company. Please proceed with your question.

Good morning, and thanks for taking the questions. I got two here. The first one is in terms of the second-gen supplement PMA application at this point. I know it's on track. Any colors in terms of what question? No, one level of question has been asked and the responses you already have. And then I have a follow-up. Thank you.

Yes, sure. Sure. Yes. Hello there. Yes. So with it with the second generation supplement, whereas, as you mentioned, and as we mentioned already, we're completely on track. We've done all types of testing around our software and we did our ventilator testing and cybersecurity testing, bootloader testing, altitude testing. We're doing all this as asked. by the FDA as part of this supplement. The supplement, as you know, was put in a year ago, and we're expecting to have our scientific letter, all the I's dotted and T's crossed, momentarily actually we're right uh we're right finishing that up and then from there um The next step is really us getting into additional communication with the FDA. Along the way, they've been incredibly communicative with us. They've gotten back to us really quickly. They're a great team. So all this information has been kind of passed back and forth, which is, you know, helping us know where we stand in the process, and we're looking forward to doing our audits in the upcoming couple of months or so and taking things from there. So, yes, we're really excited about the progress.

Okay, great. One more follow-up here is this. In terms of the $8 million guidance for 2026, would that first include the $1.9 million top line of... calendar for the first quarter of this year. And If so, would that be the case? And then also, would you call that still feasible? fiscal 2026 or something else. And thanks.

THANK YOU. I THINK I CAN TAKE THAT, BOB. IT IS A LITTLE CONFUSING, I AGREE. BUT, yes, WHEN WE'RE TALKING THE $8 MILLION FOR CALENDAR 2026, THAT WOULD INCLUDE THE 1.9 WE JUST REPORTED, PLUS CALENDARS, YOU KNOW, QUARTERS, YOU KNOW, ENDED 6, 30, 9, 30, AND 12, 31. SO THE $8 MILLION IS A PURE CALENDAR YEAR END 2026. 26th, including the quarter we just reported. Okay, go ahead. Sorry. No, no, please, please go ahead.

No, so you call the $8 million is also fiscal 26, is that right?.

IT'S NOT. AGAIN, IT'S JUST THE FOUR CALENDAR QUARTERS WITHIN 2026. SO THE ONE NINE THAT WE JUST REPORTED FOR THE JANUARY THROUGH MARCH PERIOD PLUS THE three remaining quarters in calendar 26. So, again, the $8 million is moderate growth as, you know, the Gen 2 launch isn't supposed to happen until, you know, late in the year. So we're not counting any Gen 2 revenue in calendar 2026. We expect to see the majority of that coming in beginning in January.

calendar 27. So the calendar year is aligned or identical to the fiscal year that I guess would that be correct? In other words, if we're put into the model, we are just that, or change that, that will be, for example, this quarter, the reported quarter will become Also fiscal 1Q26 quarters, would that be fair?.

The quarter we just reported at $1.9 million in revenue would be Q1-26 calendar. Yes.

Okay, great. Thank you. Thank you. Ladies and gentlemen, as a reminder, if you'd like to join the question queue, please press star 1 on your telephone keypad. Next question comes from the line of Mike King with Rodman and Renshaw. Please proceed with your question.

Good morning guys. Thanks for taking the question. A couple of things. In terms of the guidance, first of all, thank you for giving us 27 guidance. Maybe some points on that that I'd like to ask about. Number one is what proportion do you think second gen might be? Second question is in terms of these group purchasing orders, how critical is that to executing against that guidance as opposed to conquering sort of individual, you know, individual accounts. And I'll just stop there and let you answer those.

I can take the first part. I would, oh, sorry, Bob. Yes, I was going to suggest. No, no, I was going to suggest that, please. So if you're talking about 2027 revenue, again, if I was looking at the US portion, because Gen 2 wouldn't be sold internationally to begin with, but if we're talking international, or domestic, sorry, you know, it ends up being about half or maybe a little more than half. You know, we have a lot of business, as Bob mentioned, it's pretty sticky. And so we have good renewal rates. And so we'll have a lot of contracts carrying over year to year. So the Gen 2 stuff that starts coming in in 27 makes up, you know, around half of the U.S. revenue for 2027.

Okay, great. And then just with regard to sort of a conquest that you need to.

You know, you need to win in order to make those numbers? You know, it varies. Again, we're moving from a smaller TAM, so right now, without the transportability, we're dealing with much smaller hospitals and average deal size is on the smaller end. So we expect that deal size to increase right now. We don't really give out the number of hospitals exactly, but it's going to be less than what we have now, right? So if we're doubling revenue in the U.S., it's going to be probably 50% to 70% more accounts rather than having to double the number of accounts. Okay.

Okay, all right, that's helpful. Does the Gen 2, even though despite its smaller footprint, does it have the same capacity? Yes.

as the current generation lung fit? The capacity difference is, there's a couple of differences here with the two products. the Gen 2 were the major differentiator. Outside of both of them, provide unlimited nitric oxide from room air. They both are the fastest as far as speed to treatment. So these products compared to our competitors, you can start them up, you can stop them, you can start them again. And that's very important at the bedside, being able to manage patients and moving them around that way. The major difference between the two products once the Gen 2 is approved, as mentioned, not approved now, is that it'll be fully designed for transport. So it'll have the air and ground capability opening up that larger total addressable market. That's the first major one. That was the part of the market that was being missed and why the addressable market's smaller now. The other major difference the change and the predictability with how long our duration is between our starts for a device that goes into the field. When we put a device into the field, we don't have to bring it back in for any kind of maintenance. It's like four times longer. So that's something that will be a major difference for the cost of goods as well as the customers as far as managing the product. product so it's really a big difference so much easier to use it's we don't have the storage issues compared to the competitors and it will have that that transport capability so so excited about those pieces Right, okay. Thanks for taking the questions. I'll get back in the queue. Yes, and if I may, Mike, you did have that one question. It wasn't fully, I didn't get to answer around the GPOs and the criticality of that. Yes, it's going to make a big difference for us. There are some In fact, the most recent GPO that we signed, the first of April, is up and running with already doing evaluations with us. So part of our contracting, we wanted to make sure that we were able to get in front of some of the flagship hospital systems immediately so we could start doing evaluations. So we start getting product in the hospitals and we can knock the incumbents out. So this is happening now. lifetime. So, so yes, there's going to be, you know, some, some, some accounts are going to be coming on board based off of that.

Bob, do you have a number of, you know, the GPOs out there that you think are, you know, potential customers and what proportion now that?

you've penetrated? Yes, well, so I mean, listen, there's three major GPOs in the U.S. that cover roughly around 7,000 hospitals and there's all the different... that are underneath them. Within those IDNs, those are anywhere from, call it 20 hospitals to 200 hospitals, okay? And with the most recent GPO that we signed up, there's almost a couple of thousand hospitals there. And one of the evaluations that we're working with is responsible for a couple hundred hospitals. Of course, the pilots and the evals that we're doing are with regions within those. So they're groups of 10. and 17 and 22, hospitals within the IDNs. And it just kind of spiderwebs out from there. So we're appropriately approaching the evaluation process with them at the appropriate pace. So it's going great.

Good to hear. All right. Thanks very much. You got it. Thank you. At this time, we're showing no further questions in the queue, and this concludes our question and answer session. I'd now like to turn the call back over to Robert Goodman for any closing remarks.

We appreciate everybody coming on the call today, and we look forward to providing future guidance and delivering for our shareholders. Everybody have a nice day.

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