Beyond Air (BYON) FY2026 Earnings Call - FDA Approval and Gen 2 Launch Drive Revenue Inflection

Operator, Conference Call Operator: 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. Now I’d like to turn the call over to Garth Russell with LifeSci Advisors. Please go ahead.

Garth Russell, IR Advisor, 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 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 Securities 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 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.

Robert Goodman, Chief Executive Officer, Beyond Air: 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 LungFit 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 LungFit system.

This strategic focus is reflected in what we believe is an important inflection 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 LungFit 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 INO requirements, including their transport needs. As a reminder, the current label for the LungFit 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 four-fold 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 represents another important milestone in expanding access to LungFit 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 LungFit 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 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 if approved.

In terms of the other programs outside of our core LungFit 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 LungFit PH system, and we will continue to allocate our resources almost exclusively to the LungFit PH 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 continued to prepare for 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 2026 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 million-$18 million, which would represent over 110% year-over-year growth at the midpoint of that range and 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 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?

Dan Moorhead, Chief Financial Officer, Beyond Air: Thanks, Bob, and good morning, everyone. I’ll walk through our full-year financial results for the fiscal year 2026, which ended March 31st, 2026. Revenues for the fiscal year ended March 31st, 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 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%, or 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 for basic and diluted share, compared with $46.6 million, or $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 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.

Robert Goodman, Chief Executive Officer, Beyond Air: Thanks, Dan. Before we open the call for questions, I want to briefly address our Nasdaq listing. Early 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 31st, 2026. Following stockholder approval at the special meeting held on June 18th, our board approved a one 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.

Operator, Conference Call Operator: Thank you. If you’d like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two 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 Jen with Laidlaw & Company. Please proceed with your question.

Yale Jen, Analyst, Laidlaw & Company: Good morning. 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 level of question has been asked and the responses you already have? I have a follow-up. Thank you.

Robert Goodman, Chief Executive Officer, Beyond Air: Sure Yale. Hello there. With the second-generation supplement, as you mentioned, as we mentioned already, we’re completely on track. We’ve done all types of testing around our software. 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 the I’s dotted and T’s crossed momentarily, actually. We’re right finishing that up. 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.

All this information has been kind of passed back and forth, which is helping us know where we stand in the process. We’re looking forward to doing our audits in the upcoming couple of months or so and taking things from there. We’re really excited about the progress.

Yale Jen, Analyst, Laidlaw & Company: 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 sort of calendar first quarter of this year, and if so, would that be the case? Also, would you call that still fiscal 2026 or something else? Thanks.

Dan Moorhead, Chief Financial Officer, Beyond Air: Thanks, Yale. I think I can take that, Bob. It is a little confusing, I agree. When we’re talking the $8 million for calendar 2026, that would include the $1.9 we just reported, plus calendars quarters ended six, 39, 30, and 12, 31. The $8 million is a pure calendar year-end 2026, including the quarter we just reported.

Yale Jen, Analyst, Laidlaw & Company: You call-

Robert Goodman, Chief Executive Officer, Beyond Air: Yeah, Yale.

Yale Jen, Analyst, Laidlaw & Company: Okay, go ahead. Sorry.

Robert Goodman, Chief Executive Officer, Beyond Air: No, no. Please, go ahead.

Yale Jen, Analyst, Laidlaw & Company: No, you call the $8 million is also fiscal 2026, is that right?

Dan Moorhead, Chief Financial Officer, Beyond Air: It’s not. Again, it’s the four calendar quarters within 2026. The $1.9 that we just reported for the January through March period, plus the three remaining quarters in calendar 2026. Again, the $8 million is moderate growth. As you know, the Gen 2 launch isn’t supposed to happen till 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 2027.

Yale Jen, Analyst, Laidlaw & Company: The calendar year is aligned or identical to the fiscal year that I guess from that would that be correct? In other words, if we put into the model, we are just that or change that, there will be, for example, this quarter, the just reported quarter will become also fiscal Q1 2026 quarters. Would that be fair?

Dan Moorhead, Chief Financial Officer, Beyond Air: The quarter we just reported at $1.9 million in revenue would be Q1 2026 calendar. Yes.

Yale Jen, Analyst, Laidlaw & Company: Okay, great. Thank you.

Operator, Conference Call Operator: Thank you. Ladies and gentlemen, as a reminder, if you’d like to join the question queue, please press star one on your telephone keypad. Our next question comes from the line of Michael King with Rodman & Renshaw. Please proceed with your question.

Michael King, Analyst, Rodman & Renshaw: Good morning, guys. Thanks for taking the question. A couple things. In terms of the guidance of, first of all, thank you for giving us 2027 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 accounts? I’ll just stop there and let you answer those.

Dan Moorhead, Chief Financial Officer, Beyond Air: I can take the first part. Oh, sorry, Bob. Sorry.

Robert Goodman, Chief Executive Officer, Beyond Air: That’s what I was going to suggest. I was going to suggest that, please.

Dan Moorhead, Chief Financial Officer, Beyond Air: Okay. 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, if we’re talking international or domestic, sorry, 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. We have good renewal rates. We’ll have a lot of contracts carrying over year to year. The Gen 2 stuff that starts coming in in 2027 makes up around half of the U.S. revenue for 2027.

Michael King, Analyst, Rodman & Renshaw: Okay, great. Just with regard to sort of account conquest that you need to win in order to make those numbers?

Dan Moorhead, Chief Financial Officer, Beyond Air: It varies. Again, we’re moving from a smaller TAM. Right now, without the transportability, we’re dealing with much smaller hospitals, and average deal size is on the smaller end. 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? If we’re doubling revenue in the U.S., it’s going to be probably 50%-70% more accounts rather than having to double the number of accounts.

Michael King, Analyst, Rodman & Renshaw: 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 LungFit?

Robert Goodman, Chief Executive Officer, Beyond Air: 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. 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 is the change in 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 for, it’s like four times longer. That’s something that’ll be a major difference for the cost of goods as well as the customers as far as managing the product. It’s really a big difference. Much easier to use. We don’t have the storage issues compared to the competitors, and it will have that transport capability. Excited about those pieces.

Michael King, Analyst, Rodman & Renshaw: Right. Okay. Thanks for taking the questions, and I’ll get back in the queue.

Robert Goodman, Chief Executive Officer, Beyond Air: Yeah. If I may, Mike, you did have that one question that I didn’t get to answer around 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. 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. This is happening now lifetime. Yeah, there’s going to be some accounts are going to be coming on board based off of that.

Michael King, Analyst, Rodman & Renshaw: Bob, do you have a number of the GPOs out there that you think are potential customers and what proportion now that you’ve penetrated?

Robert Goodman, Chief Executive Officer, Beyond Air: Yeah. Well, listen, there’s three major GPOs in the U.S. that cover roughly around 7,000 hospitals, and there’s all the different integrated delivery networks that are underneath them. Within those IDNs, those are anywhere from, call it, 20 hospitals to 200 hospitals. Okay?

With the most recent GPO that we signed up, there’s almost 2,000 hospitals there. One of the evaluations that we’re working with is responsible for 200 hospitals. Of course, the pilots and the evals that we’re doing are with regions within those. They’re groups of 10 and 17 and 22 hospitals within the IDNs, and it just kind of spider webs out from there. We’re appropriately approaching the evaluation process with them at the appropriate pace. It’s going great.

Michael King, Analyst, Rodman & Renshaw: Good to hear. All right. Thanks very much.

Robert Goodman, Chief Executive Officer, Beyond Air: You got it.

Operator, Conference Call Operator: 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.

Robert Goodman, Chief Executive Officer, Beyond Air: 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.

Operator, Conference Call Operator: Thank you. This concludes today’s conference call. You may disconnect your lines at this time. Thank you for your participation.