This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

Beyond Air, Inc.
6/26/2026
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?
You're reading a preview of the XAIR Q4 2026 earnings call.
Free account.