Beyond Air (XAIR) Earnings Call zum 1. Quartal des Geschäftsjahres 2027: FDA-Katalysator, Ausblick von 8 Mio. USD für 2026

Beyond Air (NASDAQ: XAIR) berichtete für das am 30. Juni 2026 beendete erste Quartal des Geschäftsjahres über einen stabilen Umsatz und eine verbesserte Bruttomarge. Das Management konzentrierte sich auf die ausstehende FDA-Prüfung des LungFit PH-Systems der zweiten Generation, das Wachstum der kommerziellen Pipeline und eine erweiterte Finanzierungskapazität.

Wichtigste Erkenntnisse

• Der Umsatz im ersten Quartal des Geschäftsjahres 2027 lag bei 1,8 Mio. US-Dollar und blieb im Vergleich zum Vorjahresquartal sowie zum März-Quartal 2026 unverändert.
• Die Bruttomarge stieg von 9 % im Vorjahreszeitraum auf 13 %, was das dritte Quartal in Folge mit einem positiven Bruttogewinn markiert.
• Der den Stammaktionären zurechenbare Nettoverlust weitete sich von 7,7 Mio. US-Dollar auf 7,9 Mio. US-Dollar aus. Der Verlust je Aktie betrug 11,00 US-Dollar gegenüber 30,67 US-Dollar im Vorjahreszeitraum.
• Das Management bestätigte seine Umsatzprognose für das Kalenderjahr 2026 von 8 Mio. US-Dollar sowie die Prognose für das Kalenderjahr 2027 von 16 Mio. bis 18 Mio. US-Dollar.
• Das LungFit PH der zweiten Generation befindet sich weiterhin in der Prüfung durch die FDA. Das Management rechnet weiterhin mit einer potenziellen Entscheidung in der zweiten Hälfte des Jahres 2026, wobei der Zeitpunkt auf Basis des aktuellen Prozessstands eher in das vierte Quartal fallen dürfte.
• Beyond Air gab bekannt, dass sich seine kommerzielle Pipeline in den letzten fünf bis sechs Monaten verdoppelt hat, während seine internationalen Partnerschaften mittlerweile mehr als 40 Länder abdecken.

Wichtigste Finanzdaten

Geschäfts- und operative Entwicklung

Beyond Air setzte die Vorbereitungen für eine potenzielle kommerzielle Markteinführung seines LungFit PH-Systems der zweiten Generation in den USA fort. Das Unternehmen hat seinen PMA-Nachtrag im Juni 2025 bei der FDA eingereicht und erklärte, dass die technische Entwicklung sowie die Erstellung von Pilot-Prototypen bei seinem Auftragsfertiger voranschreiten.

Das Management gab an, dass die FDA im Wesentlichen alle erforderlichen Unterlagen erhalten hat und das Material im Vorfeld mehrerer erwarteter Audits prüft. Zudem werden die letzten Pilot-Builds fertiggestellt, um in den Audit-Prozess einbezogen zu werden.

Der kommerzielle Zugang wurde durch eine nationale Einkaufsvereinbarung mit einer dritten großen US-Einkaufsgemeinschaft (Group Purchasing Organization) erweitert. Zusammen mit bestehenden Vereinbarungen mit Premier und Vizient bieten diese Arrangements Zugang zu einem erheblichen Teil der US-Krankenhäuser und Gesundheitssysteme.

Das Unternehmen verfügt zudem über Vertriebspartnerschaften in mehr als 40 Ländern. Laut Management dürfte die gestärkte Bilanz die Fähigkeit verbessern, internationale Partner zu unterstützen, vorbehaltlich entsprechender behördlicher Genehmigungen.

Beyond Air hat sich vor Kurzem eine Finanzierung von bis zu 30 Mio. US-Dollar gesichert. Dies umfasste 10 Mio. US-Dollar an Vorab-Bruttoerlösen sowie bis zu weitere 20 Mio. US-Dollar aus der potenziellen Ausübung von kurz- und langfristigen Warrants. Die Erlöse sollen die Produktion von Pilot- und kommerziellen Geräten, den laufenden Betrieb und die internationale Expansion unterstützen.

Management-Prognose

Das Management bestätigte seine Umsatzprognose für das Kalenderjahr 2026 von 8 Mio. US-Dollar, was etwa 15 % über dem Kalenderjahr 2025 liegt. Die Prognose schließt Umsätze aus dem LungFit PH-System der zweiten Generation aus.

Das Unternehmen erwirtschaftete in der ersten Hälfte des Kalenderjahres 2026 rund 3,7 Mio. US-Dollar und erwartet in der zweiten Hälfte etwa 4,3 Mio. US-Dollar, um sein Ganzjahresziel zu erreichen. Als unterstützende Faktoren nannte das Management jüngste kommerzielle Erfolge, eine größere Pipeline, internationale Käufe sowie aktive Ausschreibungen.

Die Umsatzprognose für das Kalenderjahr 2027 bleibt bei 16 Mio. bis 18 Mio. US-Dollar. Im Mittelwert würde dies einem Wachstum von mehr als 110 % gegenüber dem Ziel für 2026 entsprechen. Im Gegensatz zum Ausblick für 2026 enthält die Prognose für 2027 Umsätze aus der potenziellen Markteinführung des LungFit PH der zweiten Generation und ist daher von der FDA-Zulassung abhängig.

Risiken und zu beobachtende Faktoren

• Zeitpunkt und Ergebnis der Prüfung des LungFit PH der zweiten Generation bleiben vom FDA-Verfahren abhängig. Das Management lehnte es ab, ein genaues Zulassungsdatum zu nennen.
• Das Unternehmen verbrennt weiterhin liquide Mittel (Cash Burn), und die zusätzlichen 20 Mio. US-Dollar an Finanzierung sind von der Ausübung von Warrants abhängig.
• Vertragsabschlüsse mit Krankenhäusern beinhalten lange Vertriebszyklen, was den Zeitpunkt der Umsatzrealisierung aus der erweiterten Pipeline beeinflussen kann.
• Die internationale Expansion bleibt von den entsprechenden behördlichen Genehmigungen abhängig.
• Der Umsatzausblick für 2027 setzt eine potenzielle kommerzielle Markteinführung des LungFit PH-Systems der zweiten Generation nach der FDA-Zulassung voraus.

Highlights der Analysten-Fragerunde (Q&A)

Das Management gab an, dass die Finanzierung in erster Linie den Betrieb, kurzfristige Gen-II-Pilot-Builds und die Geräteproduktion in größerem Maßstab nach einer potenziellen FDA-Freigabe finanzieren wird. Ein Teil der Erlöse wird auch den Cash-Bedarf des Unternehmens während der Startvorbereitungsphase decken.

Zur kommerziellen Entwicklung berichtete das Management von einer deutlichen Belebung der Vertragsabschlüsse und erklärte, dass sich die Pipeline in den vorangegangenen fünf bis sechs Monaten verdoppelt habe. Jüngste Erfolge und internationale Käufe sollen zum Umsatz in der zweiten Hälfte des Kalenderjahres 2026 beitragen.

Bezüglich der FDA-Prüfung erklärte das Management, dass der Prozess in die Audit-Phase eingetreten sei. Die Einreichung von Unterlagen sei weitgehend abgeschlossen, die Kommunikation mit der Behörde verlaufe zügig und nach den letzten Pilot-Builds werden mehrere Audits erwartet. Das Management hielt an seiner Erwartung für die zweite Hälfte des Jahres 2026 fest, räumte jedoch ein, dass eine Entscheidung im vierten Quartal angesichts des aktuellen Kalenders wahrscheinlicher erscheint.

Vollständiges Transkript des Earnings Calls

Vollständiges Transkript der Telefonkonferenz

Ausführungen des Managements

Operator

Greetings, and welcome to the Beyond Air Financial Results for the quarter ending June 30, 2026. [Operator Instructions] And now I would like to turn the call over to Corey Davis, LifeSci Advisors. Please go ahead.

Corey Davis

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 quarter ended June 30, 2026. 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. 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-K 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 call contains time-sensitive information that is accurate only as of the date of the live broadcast, August 13, 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 turn the call over to Robert Goodman, Chief Executive Officer of Beyond Air. Bob, the floor is yours.

Robert Goodman

Thanks, Corey, and good morning, everyone. With me today is Dan Moorhead, our Chief Financial Officer. As we just had our last quarterly call a few weeks ago, I'll keep my prepared remarks fairly brief. Over the past few months, we've been focused on positioning Beyond Air for its next phase of growth. We strengthened our balance sheet through an up to $30 million financing, regained compliance with Nasdaq's listing requirements, and continue to expand the commercial foundation supporting LungFit PH. Collectively, these actions have strengthened the company's financial position, increased our commercial reach, and enhanced our ability to execute on what we believe is a significant opportunity ahead of us.

As we prepare for the planned commercial launch of our second-generation LungFit PH system, pending FDA approval, our priorities are focused on continuing to expand market access, deepen relationships with hospitals and health systems, grow our commercial pipeline, and execute with financial discipline. We believe these efforts will position Beyond Air to drive broader adoption of the LungFit PH while creating a stronger platform for long-term growth. Turning to the financial results, revenue for the quarter ended June 30, 2026, was $1.8 million, which is effectively flat from the March '26 quarter. While revenue remained relatively consistent, we made meaningful progress advancing the commercial and operational initiatives that we believe will support stronger growth as we move through the remainder of the year and prepare for the planned launch of our second-generation LungFit PH system.

We continue to execute against several initiatives designed to expand market access and increase commercial adoption. During the quarter, we entered into a national group purchasing agreement with a leading U.S. GPO, becoming the third major national GPO to partner with Beyond Air. Together with our existing agreements with Premier and Vizient, these relationships provide access to a substantial portion of U.S. hospitals and health systems and represent an important component to our commercial strategy. We also continue to expand our global distribution network through new and existing commercial partnerships, further extending LungFit PH's reach into the international markets.

Another growth center for the company will be the expansion of our international distribution. We have a number of partnerships already in place that cover more than 40 countries. As a result of our strengthened financial position following the recent equity raise, we're in a better position to support our partners' efforts to bring LungFit PH to market in many of these areas. We look forward to providing updates on these programs as appropriate. As it relates to the Gen II LungFit system in the U.S., which remains under review at the FDA, we continue to believe this to be the most important near-term catalyst for the company.

We submitted our PMA supplement to the FDA in June of 2025, and based off of our interactions with the FDA to date, we continue to believe we are on track for a potential approval in the second half of this calendar year, although the timing and outcome of the review remain subject to the FDA approval process. Accordingly, we continue to prepare for a potential commercial launch. We are maintaining a disciplined and focused approach to capital allocation. We continue to dedicate our resources predominantly to LungFit PH.

In our press release issued earlier today, we reaffirmed our previously issued revenue guidance of $8 million for calendar 2026, representing approximately 15% growth over calendar year 2025. I think it is worth noting that we're not including any revenue from the second-generation LungFit for 2026. We also reaffirm our previously issued 2027 revenue guidance of $16 million to $18 million, representing more than 110% growth at the midpoint compared with our 2026 guidance. The guidance for 2027 does include revenue from the potential commercial launch for the second-generation LungFit PH system, subject to FDA approval. Looking forward, Beyond Air is approaching an important inflection point.

With continued international expansion and planned commercial launch of our second-generation LungFit systems pending approval, we have established a stronger foundation to accelerate commercial execution and drive meaningful revenue over the coming years.

With that, I'll turn the call over to Dan for a review of our financial results. Dan?

Daniel Moorhead

Thanks, Bob, and good morning, everyone. I'll walk through our financial results for the quarter ended June 30, 2026. Revenue for the quarters ended June 30, 2026, and 2025, was $1.8 million. Gross margin for the quarter ended June 30, 2026, was 13%, compared with gross margin of 9% for the same period last year. This marks our third consecutive quarter of positive gross profit. Research and development expenses for the quarters ended June 30, 2026, were $2 million, compared to $3.1 million for the same period last year. Selling, general, and administrative expenses for the quarter ended June 30, 2026, were $4.9 million, compared with $4.7 million for the same period last year. Other expense for the quarter ended June 30, 2026, was $1.5, million compared with $500,000 for the same period last year.

Net loss attributable to common stockholders of Beyond Air for the quarter ended June 30, 2026, was $7.9 million, or a loss of $11 per basic and diluted share, compared with a net loss of $7.7 million, or $30.67 per share, for the same period last year. As of June 30, 2026, we reported cash, cash equivalents, restricted cash, and marketable securities of $15.2 million. Please note, this cash total does not include our recent financing. As Bob previously mentioned, we recently announced a financing for up to $30 million, which provided $10 million in upfront gross proceeds and the potential for up to an additional $20 million upon the exercise of short- and long-term warrants. This financing provides us with the financial flexibility to execute the planned commercial launch of our second-generation LungFit PH in the U.S., pending FDA approval, as well as the international commercial expansion, subject to applicable regulatory approvals.

On our last quarterly call, we announced the change in our fiscal year-end from March 31 to December 31. While we are referring to calendar year goals, you may notice our SEC filing will still be on our March 31 fiscal year-end. We will move to calendar year reporting with the SEC subsequent to our December 31, 2026, filing.

With that, we will now open the call for questions.

Operator

With that, we will now open the call for questions. [Operator Instructions] Our first question comes from Michael King with Rodman & Renshaw. Please proceed with your question.

Fragen und Antworten

Jillian Weiss

This is Jillian Weiss on the line for Michael King from Rodman & Renshaw. So you mentioned the financing will support the Gen II LungFit PH launch and commercial rollout. Can you give us a little more detail on what the capital will actually be used for and where you expect to see the biggest investment over the next several quarters?

Daniel Moorhead

Sure, I can take that. It really is a lot for operations. So what we have going right now is we have the pilots, which are being built on the Gen II device, in the near term, and then upon FDA clearance, we'd be building a lot more devices and gaining commercial steam for 2027 and beyond. So it's really an operations function, but a lot of it is on the device. And then we are obviously in a cash burn position right now, so it will absorb some of that burn during that period as well.

Jillian Weiss

And are things starting to pick up on the contracting side, and do you think hospitals may be more willing to spend remaining budgets heading into year-end?

Robert Goodman

Yes, we've noticed a lot of pickup with contracting. Actually, our commercial functions really picked up a lot of that pace with a number of different new opportunities in front of us. Pipelines actually doubled over the last five or six months. So as you know, long sales cycle there, yet a lot of really -- a lot of this has picked up. So, yes.

Jillian Weiss

Okay, great. Thanks for taking my questions, and congrats on the quarter.

Operator

Thank you. Our next question comes from Yale Jen with Laidlaw & Company. Please proceed with your question.

Yale Jen

My first question is, any update in terms of the supplement PMA applications? What I meant is that, any interaction with the FDA and any other related stuff? Then I have a follow-up.

Robert Goodman

Yes, let me take that one, Dan. So yes, we've had a lot of activity and a lot of progress with the PMA supplement. So we've begun to submit paperwork to the FDA. They're already reviewing the paperwork, as Dan touched on. We're doing a couple of things with our contract manufacturer, finishing up our engineering build and our pilot builds of all the different products that will be validated by the FDA. So that's all part of this slew of paperwork that goes to them, and it all kind of lands on the performance qualification. It'll be a desk audit that the FDA will eventually be doing with us.

So all the different paperwork that's needed to go to them is getting to them on time. We're getting really good communication back and forth. I think I had mentioned on the last call, but this is a really good team over at the FDA. Very communicative, they get back to us within minutes or hours, sometimes days if it would typically take weeks, but they're really quick. And we're really positive on the way the process has been going.

Yale Jen

So at this point, would that still be things to be submitted, or basically everything is pretty much done except waiting for their decisions?

Robert Goodman

No, it's less of the decision piece and more of setting up. The next phase that we're in, and we're in this now, is that it's the audit phase. As they're reviewing the paperwork, they'll decide when the audits take place. There's a few different audits. We're already ready for a couple of those. And once our final pilot builds are done, which are happening now, we're doing that, then that part of the process will be dropped into their audit queue and their teams will come in and do their audits with us.

But yes, we're where we should be and they've received pretty much everything they need to receive. There's always a little back and forth, but not a back and forth that's setting us back. It's more of a, 'Hey, can you furnish us this?' 'oh, yes, that was in document A.' So, yes, everything's where it should be.

Yale Jen

Maybe just follow up on that, which is that given we are already in the midst of the third quarter right now, so should we really expect the potential decision likely be in the fourth quarter?

Robert Goodman

Yes, you know, I mean, what we're trying not to do is pinpoint an exact date. Only, Yale, the only reason for that, as you know, is it's not like with pharmaceuticals where you have a PDUFA date. Right, it's a medical device, we have to give a range. And yes, to your point, yes, we're now a month into Q3, so likely that would be a Q4 period. We're still in H2, and yes, if you want to try to figure out whether it be in Q3 or Q4, that's up to the FDA and how they're processing everything. So I guess let me step back and just say it's still going to be in H2, but we're only a month and a half away from Q4.

Yale Jen

Great. Maybe the last question, which is slightly different from the earlier one, which is that, given that the guidance you have $8 million to $10 million revenues for this year, the calendar '26, so a majority of them will come from the second half, which is starting this quarter. And just curious, what are the confidence at this point to support you feel that the second half will be -- have a greater revenue growth versus the first half?

Robert Goodman

Yes, so a couple of pieces on that, and Dan can definitely weigh in as well. But no, not $8 million to $10 million. The guidance was $8 million for this year. And so we're looking, really it's, if we could roll in about $3.7 million in H1, that means around $4.3 million in H2, and we're very confident that we'll be hitting that number. And the reason being is the pipeline that I referred to earlier. We've already started to see wins come in the quarter we're in right now, which will have some impact on the H2 numbers.

And then in addition to that, our international is starting to pick up a little bit, which is good. And that's immediate revenue recognition, as you know, because those are all being purchased. And then under our subscription model, where if you grab $1 million of business, it's not spread out over 12 months, and if we close that deal in November, you're really only getting a couple of hundred thousand dollars, you get the whole $1 million, right? So we have a lot of tenders that we have our hands firmly around.

We have already won a number of opportunities within this quarter that we know will be seeing that bump up as well. So, yes, we're reaffirming certainly the $8 million and we're also firmly standing behind our 2027 guidance. So, yes, I hope that answers that.

Yale Jen

That's very helpful. I appreciate it. And best of luck going forward. And thanks.

Operator

We have reached the end of our question-and-answer session. I would now like to turn the floor back over to Robert Goodman for closing comments.

Robert Goodman

I just want to thank everybody for joining the call this morning and for all your support. And we look forward to continuing to provide feedback and updates, and look forward to our next call together. Have a great day.

Operator

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