Beyond Air, Inc.

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. Please go ahead.

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 31, 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 to remind 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 cause actual results to differ materially from those indicated. We encourage everyone to review the company's filings with the Security and Exchange Commission, including, without limitation, the company's most recent Form 10-K and Form 10-Q, which identifies specific factors that may cause extra results or events to differ materially from those described in the four 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 Air during what I believe is a pivotal moment for the company. Over 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 Lungfin 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 OneFit 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. Thank you. Thank you. 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 1,5-pH across the U.S. Combined with our existing agreements with Premier and Vizion, 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 continue 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 50H 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 Gen 2 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. As a result, we believe the Gen 2 platform could represent an attractive option for certain institutions approved. In terms of the other programs outside of our core OneFitPH 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 CPO relationships, strengthened our international footprint, and continue to prepare what will be a transformational Gen 2 launch, if approved. We believe the strategy I've discussed today establishes a clear roadmap for continued growth. With Fiscal 26 complete, we are 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 in 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 Gen 2, 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'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 four-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 Lung Fit pH in both U.S. and international markets. Gross profit for fiscal year 2026 improved $300,000 compared with a 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 to $3.9 million for fiscal year 2025. Net loss attributable to common stockholders of Beyond Air for fiscal year 2026 was $33.2 million for a loss of $4.01 for basic and diluted share compared with $46.6 million for $13.77 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 31st, 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 the Harvard NASDAQ list. Earlier this month, we announced that the NASDAQ Herons 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. Following stockholder approval at the special meeting held on June 18, 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'll 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 keys. Our first question comes from the line of Yale Gen with Laidlaw and Company. Please proceed with your question.

Good morning and thanks for taking the questions. I've got two here. The first one is in terms of the second gen supplement DMA application at this point. I know it's on track. Colors in terms of what level of question has been asked and the responses you already have. And then I have a follow-up. Thank you.

Yeah, sure. Sure, yeah. And hello there. Yeah, so with the second-generation supplement, 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, EMC 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 – All the I's dotted and T's crossed momentarily, actually. We're right finishing that up. And then from there, 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 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, yeah, we're really excited about the progress.

Okay, great. One more follow-up here is in terms of the $8 million guidance for 2026, would that first include the $1.9 million top line of sort of Thank you. I think I can take that, Bob. It is a little confusing, I agree.

But, yeah, 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, including the quarter we just reported.

Okay, go ahead.

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 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 The quarter we just reported at $1.9 million in revenue would be Q126 calendar, yes. Okay, good. 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. Our 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, but 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 accounts. And I'll just stop there and let you answer those.

I can take the first part.

I was going to suggest that, please.

So if you're talking about 2027 revenue, again, if I was looking at the U.S. portion, because Gen 2 wouldn't be sold internationally to begin with. But if we're talking domestic, it ends up being about half or maybe a little more than half. 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 2027 makes up around half of the U.S. revenue for 2027.

Okay, great. And then just with regard to sort of the count conquest that you need to, you know, you need to win in order to make those numbers?

You know, it varies. You know, again, we're moving from a, you know, a smaller CAM. So right now, without the transportability, we're dealing with much smaller hospitals and average deal size is on the smaller end. And so we expect that deal size to increase. Right now, you know, we don't really give out the number of hospitals exactly, but, you know, 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. All right. That's helpful. Does the Gen 2, even though despite its smaller footprint, does it have the same capacity as the current generation lung fit?

The capacity difference is, there's a couple of differences here with the two products. The Gen 2, 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 capabilities 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 is smaller now. The other major difference is the change and the predictability with how long our duration is between our starts for a device So 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. So it's really a big difference. So much easier to use. We don't have the storage issues compared to the competitors. And it will have that transport capability. So excited about those pieces. Right.

Okay. Thank you for taking the questions. I'll get back in the queue.

And if I may, Mike, you did have that one question. It wasn't fully – I didn't get to answer the GPOs and the criticality of that. Yeah, it's going to make a big difference for us. There are some – in fact, the most recent GPO that we signed, the 1st 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 and a number of other people. Yeah, 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, you know, integrated delivery networks 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. But so we're appropriately approaching. 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.

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