NASDAQ:XAIR Beyond Air Q3 2026 Earnings Report $2.55 -0.29 (-10.21%) Closing price 04:00 PM EasternExtended Trading$2.63 +0.08 (+3.14%) As of 07:24 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. ProfileEarnings HistoryForecast Beyond Air EPS ResultsActual EPS-$17.00Consensus EPS -$10.80Beat/MissMissed by -$6.20One Year Ago EPSN/ABeyond Air Revenue ResultsActual Revenue$2.19 millionExpected Revenue$2.15 millionBeat/MissBeat by +$48.00 thousandYoY Revenue GrowthN/ABeyond Air Announcement DetailsQuarterQ3 2026Date2/13/2026TimeBefore Market OpensConference Call DateFriday, February 13, 2026Conference Call Time8:00AM ETUpcoming EarningsBeyond Air's Q2 2027 earnings is estimated for Tuesday, November 10, 2026, based on past reporting schedules, with a conference call scheduled on Monday, November 9, 2026 at 4:30 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Beyond Air Q3 2026 Earnings Call TranscriptProvided by QuartrFebruary 13, 2026ShareShareShare This ReportLink copied to clipboard.Key Takeaways Positive Sentiment: Revenue grew 105% year‑over‑year to $2.2M, with an installed base of more than 45 hospitals, customer retention above 90%, and over half of customers on multi‑year agreements, indicating early commercial traction. Positive Sentiment: Commercial momentum includes national GPO agreements with Premier and Vizient, the first sale into a VA Medical Center, expansion of distribution to 40 countries, and repeat international accessory orders, supporting broader adoption. Positive Sentiment: Management expects FDA clearance for the Gen 2 LungFit PH system by the end of calendar 2026 and says Gen 2’s smaller size, transport compatibility, simplified operation, and extended service intervals should expand the addressable market. Negative Sentiment: Timing risk remains for Gen 2 because launch is contingent on a contract manufacturer inspection and continued engagement with the FDA, which could delay approval or commercialization. Positive Sentiment: Operating expenses fell ~36% YoY to about $6.9M, net loss narrowed to $7.3M, cash and equivalents were $17.8M at quarter end, and subsequent financings give management confidence in a runway into calendar 2027, albeit conditional on meeting revenue and cost targets. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallBeyond Air Q3 202600:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Operator00:00:00Good morning, and welcome everyone to Beyond Air Financial Results Call for the fiscal quarter ended December 31st, 2025. At this time, all participants are in listen-only mode. A question-and-answer session will follow the formal presentation. And now I'd like to turn the call over to Corey Davis of LifeSci Advisors. Please go ahead. Corey DavisManaging Director at LifeSci Advisors00:00:20Thank 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 third quarter of fiscal 2026, ended December 31st, 2025. A copy of this press release can be found on our website, 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 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. Corey DavisManaging Director at LifeSci Advisors00:01:06We 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 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 conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, February 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 Steve Lisi, Chief Executive Officer of Beyond Air. Steve, go ahead. Steve LisiCEO at Beyond Air00:01:57Thanks, Corey, and good morning to everyone. With me here today is Dan Moorhead, our new Chief Financial Officer. It has been a pleasure working with Dan over the past several months. He brings a proven track record as a proactive CFO with demonstrated success supporting commercial organizations through periods of rapid growth. I also look forward to his active engagement with the investment community as he becomes fully integrated into the role. Also joining us today is Bob Goodman, our Chief Commercial Officer. Bob assumed the role in October after previously joining Beyond Air as a board member back in June. Let me start my prepared remarks by saying just how pleased I am to speak with you today and provide an update on what has been a productive and meaningful period for our company. Steve LisiCEO at Beyond Air00:02:38We have achieved several significant milestones, strengthened our balance sheet to support continued commercial execution, and made a strategic decision to sell our Neuronas subsidiary in exchange for equity in the acquiring company and up to $32.5 million in upfront development and commercial milestone payments. We believe these recent events have strengthened our ability to execute our commercial strategy and create long-term value for our shareholders. Let me walk you through these updates in greater detail. Starting with our core business, revenue in the fiscal quarter increased 105% year-over-year to $2.2 million. This represents continued progress as we scale adoption and expand awareness of LungFit PH in clinical settings. We now support more than 45 hospitals across the United States and internationally that have adopted our first-generation LungFit PH system. Steve LisiCEO at Beyond Air00:03:26Customer feedback has been encouraging, with retention exceeding 90% and more than half of customers under multi-year agreements. We believe this installed base positions us well to support continued revenue growth from our first-generation system while preparing for the anticipated FDA decision for our second-generation system. Steve LisiCEO at Beyond Air00:03:42Our commercial team continues to refine its targeting strategy, prioritizing hospitals most likely to adopt our LungFit PH today and expand usage following approval of the second-generation system, which we expect to receive before the end of calendar 2026, subject to regulatory review and clearance. We are making steady progress building relationships with clinicians, administrators, and healthcare systems. Our current objective is to continue expanding Gen 1 system utilization through calendar 2026 in the U.S. and internationally, while preparing for the potential launch of our second-generation system once approved. Steve LisiCEO at Beyond Air00:04:18As previously discussed, Gen 2 system is designed to offer reduced size and weight, simplified operation, extended service intervals, improved backup system functionality, and very importantly, compatibility with both air and ground transport. We believe these enhancements will expand the addressable market relative to Gen 1 and support broader adoption over time. At this point, I'm going to pass the call over to Bob Goodman, who has made excellent progress since taking the reins as Chief Commercial Officer about four months ago. Bob? Bob GoodmanChief Commercial Officer at Beyond Air00:04:47Thanks, Steve, and let me begin by saying, I share Steve's enthusiasm about the opportunities ahead for Beyond Air. I as well believe that LungFit PH is the best-in-class nitric oxide solution globally. Feedback from U.S. customers and international partners on system performance and customer support have been extremely positive, providing a solid foundation for continuous growth. We have national group purchasing organization agreements with Premier and Vizient, which together provide access to nearly 3,000 hospitals across the United States. As awareness of LungFit PH increases, we expect additional opportunities at the GPO and integrated delivery network level in 2026. As previously announced, we have been working with TrillaMed to support our engagements with the federal healthcare systems. I am pleased to announce that together with this valued partner, we completed the first sale of LungFit PH to a VA Medical Center. Bob GoodmanChief Commercial Officer at Beyond Air00:05:46This initial commercial sale to the VA hospital system establishes an important foothold, opening potential pathways for future orders and broader adoption across the system, and provides access to the largest healthcare network in the United States. Internationally, we continue to see strong engagement from our distribution partners. Over the past several months, we've expanded our global LungFit PH distribution network with new agreements in Canada, Germany, Brazil, Austria, the Netherlands, and Sri Lanka, bringing total international coverage to 40 countries. As we broaden our global footprint, we are laying the groundwork for long-term growth and positioning Beyond Air to serve a significantly larger addressable market. It is important to note that we are live in a few hospitals with LungFit PH, and have already begun to see repeat orders for accessories from several countries. Bob GoodmanChief Commercial Officer at Beyond Air00:06:44Taken together, these commercial, operational, and strategic developments give me confidence in the trajectory of the business. What also gives me confidence are the people at Beyond Air. The dedication of this team is second to none, and I've been in this business for decades. This includes all the aspects of the team, from clinical support, to marketing, to customer service, to engineering, to finance, to regulatory, to quality, et cetera. Our people are fully engaged and dedicated to the vision of improving the lives of patients and medical staff with LungFit PH. Bob GoodmanChief Commercial Officer at Beyond Air00:07:19I also want to emphasize the advantages, as Steve mentioned earlier, on our second generation system. From my time spent with customers and potential customers in the United States, I believe that the Gen 2 system addresses everything on the wish list from clinicians in hospitals. I'm extremely confident that I, along with the team here, will execute on our vision of becoming the global nitric oxide leader. Now I'll turn things back over to Steve. Steve LisiCEO at Beyond Air00:07:45Thanks, Bob. Turning to Beyond Cancer, we recently announced that our abstract was selected for the 2026 AACR Annual Meeting, which is taking place from April 17th to 22nd in San Diego, California. As previously announced, the study enrolled 10 subjects at doses of 25,000 and 50,000 parts per million of nitric oxide gas, delivered over five minutes intratumorally. These patients all had metastatic disease and were heavily pretreated. All subjects had a life expectancy of less than 12 months. We have already reported that the safety profile observed to date is acceptable. The data presented at AACR will include updated overall survival data, for which median survival has not yet been reached as of October 1st, 2025. We remain dedicated to pursuing the phase I-B combination study with anti-PD-1 therapy, and we will communicate more details as we progress. Steve LisiCEO at Beyond Air00:08:39With respect to Neuronas, our neurology-focused subsidiary, on January 13th, 2026, XTL Biopharmaceuticals announced a binding letter of intent to acquire Neuronas in exchange for Beyond Air's approximately 85% ownership interest. Consideration includes a 19.9% stake in XTL, $1 million in cash, and milestone-based contingent payments totaling up to $31.5 million. Following closing, Neuronas is expected to serve as XTL's flagship platform for autism and neuro-oncology development. We believe this agreement provides the potential to create meaningful value for our shareholders by enabling Neuronas' pipeline to advance with dedicated focus and funding through XTL Bio. We will not provide additional commentary beyond public disclosures while the transaction remains pending. Steve LisiCEO at Beyond Air00:09:31To conclude, the $5 million financing completed in January 2026, together with the previously announced promissory note and equity line of credit for up to $32 million with Streeterville Capital that we announced in November 2025, provide resources to support commercial execution and readiness for the second-generation LungFit PH system. We remain focused on disciplined execution and delivering advanced nitric oxide solutions to clinicians and patients around the world. Now I will turn it over to our CFO, Dan Moorhead. Dan MoorheadCFO at Beyond Air00:10:01Thanks, Steve, and good morning, everyone. I'm excited to join my first call since being appointed CFO about seven weeks ago. I still have a lot to learn, but I'm incredibly impressed by what the team has achieved, not just over the past year, but even within the past few months. The progress has been extraordinary, and I see a bright future ahead as the team continues to execute on our growth strategy. Our financial results for the third quarter of fiscal year 2026, which ended December 31st, 2025, are as follows: Revenue for the fiscal quarter ended December 31st, 2025, increased 105% to $2.2 million, compared with $1.1 million for the fiscal quarter ended December 31, 2024. On a sequential basis, this represents a 21% increase compared with last quarter. Dan MoorheadCFO at Beyond Air00:11:00Gross profit increased to $300,000 for fiscal third quarter 2026, compared to a gross loss of $200,000 for the same period last year, and a gross loss of $300,000 in the prior quarter. Turning to operating expenses, we continue to see reductions across SG&A, R&D, and in our supply chain as a result of cost reduction initiatives taken in the past 12 months, as well as the decrease in R&D costs related to our Gen 2 device, which are mostly behind us since the PMA was filed with the FDA. Total operating expenses for the fiscal third quarter of 2026 were reduced to approximately $6.9 million, which is down from $10.7 million for the same period last year. Dan MoorheadCFO at Beyond Air00:11:54This translates to a 36% reduction year-over-year, and a greater than 60% reduction from the high of $17 million at its peak... Research and development expenses were $2.4 million for fiscal third quarter of 2026, as compared to $3 million for the same period last year. As I mentioned earlier, the year-over-year decrease was primarily driven by lower development costs associated with our Gen 2 device, with the remaining reduction attributable to a decrease in headcount and related costs. SG&A expenses for the quarters ended December 31st, 2025, and December 31st, 2024, were $4.5 million and $7.7 million, respectively, a decrease of 42% year-over-year. Almost all of the decrease of $3.3 million was from a reduction in employee-related costs. Dan MoorheadCFO at Beyond Air00:12:57Other expense was $1 million, compared to $2.4 million for the same period a year ago. The decrease in expense of $1.5 million was primarily attributed to the prior period loss associated with the extinguishment of debt of $1.9 million. Net loss attributed to common stockholders of Beyond Air was $7.3 million, or a loss of $0.85 per share, basic and diluted, compared with $13 million, or a loss of $2.96 per share, basic and diluted. Please note that the per share results for both periods were calculated to reflect the company's 1-for-20 reverse stock split, which became effective on July 14th, 2025. Net cash burn for the quarter was $4.3 million, which is a reduction of over 40% versus a year ago. Dan MoorheadCFO at Beyond Air00:13:58We believe our overall cash burn will continue to reduce as revenue grows and will only get better until we get approval and start building inventory in preparation for the launch of Gen 2. As of December 31st, 2025, we reported cash, cash equivalents, restricted cash, and marketable securities of $17.8 million. Subsequent to the end of the third quarter, we completed a $4.5 million dollar equity financing, net of issuance costs, and we believe this capital provides us with a cash runway into calendar year 2027 and potentially to profitability, provided we continue to hit our current revenue estimates and continue to control costs. With that, I'll hand the call back to Steve. Steve LisiCEO at Beyond Air00:14:53Thanks, Dan. Operator, we'll take questions now. Operator00:14:56Thank you. At this time, if you'd like to ask a question, please press star one from your telephone keypad and a confirmation tone will indicate your line is in the question queue. Let me press star two if you'd like to withdraw your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please, while we poll for our first question. Thank you. The first question comes from the line of Mike King with Rodman & Renshaw. Please proceed with your questions. Mike KingDirector of Research at Rodman & Renshaw00:15:26Thanks for taking the question. Good morning, guys. I have a couple of questions, if you don't mind. I just wonder if you could talk a little bit more about the sales process. I think it's a great breakthrough that you, you know, you've got sales into the VA system, or VA hospital, I should say. But it brings up the topic of the VA system, as you mentioned. How do you penetrate systems rather than a single hospital at a time? What needs to happen in terms of the sales process or the RFPs or things like that that can, you know, see us knocking off, you know, more than one healthcare facility at a time? Steve LisiCEO at Beyond Air00:16:14Yeah, Mike. Thanks for the question. Yeah, go ahead, Bob, you take this one. Bob GoodmanChief Commercial Officer at Beyond Air00:16:19Yeah, sure. And then, then you can definitely provide any color you like, Steve. Thank you. Yeah. So, Mike, yeah, with the VA system, we're, we're on, as, as you know, and, our product is being offered through the ECAT system. So that catalog, actually, makes it an easier approach for our customers to get to us directly. It's outside of an RFP process, but we're still. Mike KingDirector of Research at Rodman & Renshaw00:16:40Oh, it is. Bob GoodmanChief Commercial Officer at Beyond Air00:16:42Yeah, we're still able to actually compete with other RFPs that come out through. You know, there's a couple of different ways that the VAs, you know, contract with vendors. But yeah, we have access that way, so it's great. Mike KingDirector of Research at Rodman & Renshaw00:16:56Okay. And in your formal comments, you mentioned words to the effect that you're identifying facilities most likely to acquire, you know, the system. How do you or can you say how you identify them and, you know, maybe help us understand how you're targeting those facilities? Bob GoodmanChief Commercial Officer at Beyond Air00:17:18Yeah. So we've done a really good job standing up our commercial organization, both in the U.S. and internationally. And right now what we're doing is we're focusing, and not to say an overhaul, but more of an exactness with our people and our process and our technology. So you know, different prospecting tools with good intelligence and good CRM rigor to follow up with the customers and taking the process of, you know, real good demand generation, where we're getting top of the funnel looks at our customers. Bob GoodmanChief Commercial Officer at Beyond Air00:17:48Having really good pipeline discipline so we could get in front of the right customers and then to have our people, the people part of it, you know, in the right places at the right time, with the right coverage. So we have that right, you know, reach and frequency, getting in front of these customers and just getting in front of more and more. So we have that, that touch. So, so yeah, we've been really refining that and, and the customers are really responding well for our ability to get in front of them. Mike KingDirector of Research at Rodman & Renshaw00:18:14Well, that's great. Has there been any appreciable change in the length of the sales cycle? Bob GoodmanChief Commercial Officer at Beyond Air00:18:22Yeah, I mean, that, that pretty much, Mike, still remains the same. At, at the real front end, you know, if you get kind of real lucky based off of, you know, the timing of a contract that might be expiring and, and that customer is really, really organized, and you can knock out a real quick demo and evaluation, you can do that in that four or five month time frame. But it's really in that right around six to nine months, and it could be longer. But, but what we're doing is a good job, you know, identifying, the customers and, and again, you know, reaching out to them and finding out where they're at with their contract and making sure that they see the value of our product. Bob GoodmanChief Commercial Officer at Beyond Air00:18:57And with that, you know, we're hoping that might, you know, restrict things just a bit. But we're really organized, and our clinical teams are out there in the field with our sales teams to make sure that we're in front of them as early as possible. Mike KingDirector of Research at Rodman & Renshaw00:19:11Okay. And I apologize, one more quick one. How do you segment or can you segment the next gen system so that, you know. This is typical of a lot of businesses where, you know, a next generation chip, let's say, is coming out or something and, you know, the sales cycle kind of, you know, concertina effect, where, you know, the purchaser may hold off until the next gen system is available. Is that a concern, or are you, you know, segmenting a different market with the new system? Thank you. Bob GoodmanChief Commercial Officer at Beyond Air00:19:49Yeah. So we're focusing right now, as you'd expect, on our first generation product, and it's been really well received, the version 24 of gen one. So, and we're focusing on the non-transport systems, okay? And we're being really well received there as there's natural conversations within the market for the transportation systems. That's a later on gen two conversation, and we're really kind of breaking away from those conversations, but being aware that these are, you know, systems that are gonna, you know, want to be working with us in the future. Mike KingDirector of Research at Rodman & Renshaw00:20:24Okay. All right. Thanks for indulging me, guys. Bob GoodmanChief Commercial Officer at Beyond Air00:20:27You got it. Steve LisiCEO at Beyond Air00:20:28Thanks, Mike. Operator00:20:30The next question is in the line of Marie Thibault with BTIG. Please just proceed with your question. Marie ThibaultManaging Director at BTIG00:20:36Good morning. Thanks for taking the questions, and welcome, Bob and Dan. Wanted to quickly just check in on anything, any communications you've been having with the FDA on the gen two process to speak to your confidence in the timeline. I think you said by end of calendar year. And then what will be needed to do post-clearance in terms of building inventory, kind of a timeline we might think about before you can go into a formal launch and ramp? Steve LisiCEO at Beyond Air00:21:03Okay. Thanks, Marie. Well, I'll comment on the FDA side. So we've been having fairly constant communication with FDA, and, you know, we're very happy with the interaction. You know, we don't really see any major hurdles. Everything the FDA has asked for, we'll provide them. Shouldn't be a problem. And I'm sure there'll be the process will continue with FDA, and we'll continue to answer the questions as we go forward. You know, we still are waiting on the work to be completed with our contract manufacturer so we can be inspected. And that's essentially, in our minds, what the gating factor will be from a timing perspective. So we feel highly confident in the timelines that we provided, given the state of affairs today. I don't know if I- Marie ThibaultManaging Director at BTIG00:21:54All right. Steve LisiCEO at Beyond Air00:21:55Gave you the answer you needed. Marie ThibaultManaging Director at BTIG00:21:55No, that- Steve LisiCEO at Beyond Air00:21:56If there's other things you want to ask. Marie ThibaultManaging Director at BTIG00:21:57Yeah, yeah. That's great to hear. Thank you for that, Steve. And then I guess I'll ask a quick follow-up here on the international side. I know you've got some great partnerships and some efforts going on there. So any wins or any catalysts to think about on the international side? And thanks for taking the questions. Steve LisiCEO at Beyond Air00:22:13Sure. Bob, you want to take the international question? Bob GoodmanChief Commercial Officer at Beyond Air00:22:16Yeah, sure. So we have had some recent wins, which is great. I think, as you know from the past calls, it was all about setting up and getting our distributors armed with our demo devices so they can get in front of the systems. But then there's the whole part of the process with whether it's Europe or Middle East or Australia, where it's mostly tenders, compared to the U.K. or Portugal, where there's, you know, a natural, you know, a national frame or, you know, you get that hunting license like Germany and APAC, where you can go direct. So with all those different regions, yeah, we've had wins. And on top of having wins, we're now actually seeing customers reorder filters. So, you know, the product is being deployed into hospitals now, which is great, and we're starting to again get that stickiness, so it's fantastic. Marie ThibaultManaging Director at BTIG00:23:05All right. Thank you so much. Bob GoodmanChief Commercial Officer at Beyond Air00:23:07Yeah. Steve LisiCEO at Beyond Air00:23:08Thanks, Marie. Operator00:23:10Our next question is from the line of Justin Walsh with JonesTrading. Please proceed with your question. Justin WalshDirector of Healthcare at JonesTrading00:23:16Hi, thanks for taking the question. Wondering if you can provide any color on what attracted XTL Biopharmaceuticals to be interested in the Neuronas opportunity, and then how, I guess, collaboration or working with them will look going forward, given that you still have a stake in that company? Steve LisiCEO at Beyond Air00:23:36Well, thanks for the question. So, yeah, Justin, look, you know, XTL was, you know, was, you know, a company looking for an asset, and there were multiple, choices for them. I think what excited them about this opportunity is the science. I mean, there's been two, two papers, landmark papers, published about the work done by, Dr. Amal, who's the scientist, you know, and the innovator behind this, this approach to treating autism as, as well as, glioblastoma. I just want people to recognize that the, the functions of nitric oxide in the brain are, are numerous. So I think that's what, what attracted them to this. There's a clear path to human studies. Steve LisiCEO at Beyond Air00:24:23I think a lot of the work that's been done by the Neuronas team has given that clarity to anybody who's taken a look under the hood. So I think it's just a matter of you know, providing the FDA what they require, which is pretty straightforward. It's just a matter of getting that work done. So with XTL coming up with funding, they'll be able to bring this into humans. So I think the attractiveness was great science, clear path to human trials, and as everyone on this call probably knows, you know, translating efficacy from rodents to humans is something that's difficult to predict, but we'll find out, and I think that's what attracted them. We're going to get there and do that study and figure out if the efficacy translates. Steve LisiCEO at Beyond Air00:25:10If it does, you know, we're looking at a potential treatment for autism and glioblastoma at this point. It's very exciting. Just a little bit early for Beyond Air to maintain and fund. This is why the transaction was done, and we're very happy that a lot of this transaction for Beyond Air is us getting a 20% stake in the new entity. That's the confidence we have that this is going to be in human trials. We have confidence on the safety side for sure, and the efficacy side, we'll see what happens. Justin WalshDirector of Healthcare at JonesTrading00:25:49Got it. Thanks. Steve LisiCEO at Beyond Air00:25:50Thanks. Operator00:25:53The next question is from the line of Jason Kolbert with Dawson James Capital. Please proceed with your questions. Jason KolbertDirector of Research at Dawson James Capital00:25:59Good morning, guys. Can we talk a little bit about COGS and how COGS performed in the quarter? Over the next couple of years, what do you think a sustainable COGS is? Steve LisiCEO at Beyond Air00:26:15Dan, you wanna take that one? Dan MoorheadCFO at Beyond Air00:26:19Sure. You know, we tend to see Gen 1, you know, again, we think we're in the, and Steve can help me on this. I'm still pretty new on it, but, you know, we expect COGS long term as we get to scale, you know, in the 60% range and, and moving up towards 70 with the Gen 2 product. But in the near term, again, with, with revenue levels growing, but growing at a more moderate pace until we hit the Gen 2 launch, again, I think you're gonna see it pretty close to that, what you saw in Q3 and continue to grow from there. But, long term, I think that gives you a little profile, and I'm guessing you guys have possibly talked about that in the past as well. Jason KolbertDirector of Research at Dawson James Capital00:27:07And just to follow- Steve LisiCEO at Beyond Air00:27:09Just follow up on what Dan said, if you don't mind. You know, so, yeah, I think, I think Dan's right in, in what he says, but I, I would... You know, there are a couple of factors and like Dan said, he's barely two months in. There are a couple of factors that we're still trying to figure out with respect to the, to the margin on, and that would be from a pricing side of the market. Steve LisiCEO at Beyond Air00:27:28So I think, you know, that goal of 70% with the Gen 2 is a great goal. That's the target. You know, if it's 65, it's 65, you know, that's not the end of the world for us, but I think that's our target, and I think we'd like to hit it. You know, target with gen one would be to get close to 60, but again, I, I think a gen one is more of a 50s type thing. But again, it's, it's gonna depend on how the price shakes out in the market at the end of the day. And you know, that remains to be seen. Jason KolbertDirector of Research at Dawson James Capital00:27:59Okay. Steve LisiCEO at Beyond Air00:27:59You had a follow-up, Jason, go ahead. Jason KolbertDirector of Research at Dawson James Capital00:28:02Yeah. Very helpful. Can you talk also about SG&A and how sensitive the sales cycle would be to, you know, increasing SG&A, hiring additional salespeople? You know, how does that impact kind of revenues? What I'm trying to do is get a handle on, you know, more capital deployed in SG&A, does that translate into more revenues? Steve LisiCEO at Beyond Air00:28:30Well, Jason, I mean, you know, you got. Operator00:28:33Thank you. The next question is from the line of Yale Jen with Laidlaw. Please proceed with your question. Yale JenManaging Director and Healthcare Equity Analyst at Laidlaw00:29:05Good morning, and thanks for taking the questions. Just in the press release, you mentioned, you mentioned that for the Gen 2, there has the potential of extending the service intervals. Could you elaborate a little bit more on that specific aspect? Hello, can you hear me? Steve LisiCEO at Beyond Air00:29:33Hello? Operator00:29:37Hey, your line is live for a question. Please go ahead. Steve LisiCEO at Beyond Air00:29:43Are you with us? Yale JenManaging Director and Healthcare Equity Analyst at Laidlaw00:29:45Yes, I am. Operator00:29:49Thank you. Yale JenManaging Director and Healthcare Equity Analyst at Laidlaw00:29:49Hello, can you hear me? Operator00:29:51Please stand by, ladies and gentlemen. We're experiencing technical difficulties. Our conference will resume momentarily. Thank you. Please remain on the line. Our conference will resume momentarily. Please remain on line, ladies and gentlemen, our call will resume momentarily. Thank you. Steve, you're now reconnected. Please continue. Caller, please go ahead with your question. Yale JenManaging Director and Healthcare Equity Analyst at Laidlaw00:31:11Sure. Thanks. Hey, Steve. Thanks for taking the questions. I believe in the press release you mentioned that the second gen will have the potential of extending the service intervals. Could you elaborate a little bit more specifically on this particular aspect? And then I have a follow-up. Steve LisiCEO at Beyond Air00:31:31Yeah, thanks. Yeah, thanks, Yale. Appreciate that question. So the current, the current system, the first generation system, every 1,000 hours, we need to bring it in for service. So that, that can be, you know, that can, it could be a slight disruption for the hospital if they're using, you know, a couple 1,000 hours a year per machine, so we might be in there every six months, rotating machines. So it, it, it's a smooth process, but it's an expensive process for us, right? So we just come in, drop them a new machine and pick that one up and bring it in for service. So it's not very frequent, but, you know, it's, it's something we'd like to improve upon. Steve LisiCEO at Beyond Air00:32:14So with the second generation machine, you know, we think that service interval will be pushed out to at least 3,000 hours before we need, and potentially longer. So testing is still going on. We haven't reached that juncture yet where the reliability testing that we're doing has stopped. So it's still ongoing. So we're past the 3,000-hour mark at this point, which means, you know, it's at least 3 times longer before we have to go in. So if we were going in every, at a hospital, let's say we're going in every 10 months, now we're going in every 30 months on average before we have to swap out the machine. Steve LisiCEO at Beyond Air00:32:49So that's, it's certainly better for the hospital, from that standpoint, although I don't think the swap outs are really a problem for them because our team does a great job, and it runs so smooth. But from a gross margin perspective, I think that's the impact that you heard about earlier on a question when Dan and I were responding to the gross margins between Gen 1 and Gen 2. Yale JenManaging Director and Healthcare Equity Analyst at Laidlaw00:33:12Okay, great. And maybe just attach on that to this one a little bit, which is that would this be needed? You mentioned you're still testing for maybe even longer, so, you know, interval for the service needed. Would that be required before you you know, submit or for the gen two review, or that's something that could be the gen two review without the without having this particular aspect? Steve LisiCEO at Beyond Air00:33:44No, this is so there is a reliability hurdle with FDA. We've already passed that hurdle, so anything that we get is just more of a, you know, a guide for us for service with our customers. That's really what it is. So it's not a gating factor for FDA approval. Yale JenManaging Director and Healthcare Equity Analyst at Laidlaw00:34:08Okay, great. Maybe it's one more question. So on the oncology side, that since you guys already have a little bit more cash in hand, should we think about the phase II, phase I-B study potentially to start later this calendar year? And thanks. Steve LisiCEO at Beyond Air00:34:30Well, I don't know when it will start, Yale. We're certainly speaking with people and looking at that, so I don't want to commit to a timeline at this point. You know, while we do have a nice balance sheet at this moment in time, I think we need to focus the balance sheet on the commercial operations at this point. So it would probably not be something that Beyond Air would commit to fully fund a study like that. Maybe once we are more comfortable with our path to profitability, that could be a different conversation that we have internally. Yale JenManaging Director and Healthcare Equity Analyst at Laidlaw00:35:14Okay, great. That's very helpful, and congrats on the good quarter in terms of the top line. Steve LisiCEO at Beyond Air00:35:21Great. Thanks, Yale. Operator00:35:25Thank you. At this time, we are showing no further questions in the queue, and this concludes our question and answer session. I would now like to turn the call back over to Steve Lisi for any closing remarks. Steve LisiCEO at Beyond Air00:35:35I'd like to thank everybody for dialing in today. Bye-bye. Operator00:35:41Thanks, everyone, for their time today. You may now disconnect your lines at this time, and have a wonderful day.Read moreParticipantsExecutivesBob GoodmanChief Commercial OfficerDan MoorheadCFOSteve LisiCEOAnalystsCorey DavisManaging Director at LifeSci AdvisorsJason KolbertDirector of Research at Dawson James CapitalJustin WalshDirector of Healthcare at JonesTradingMarie ThibaultManaging Director at BTIGMike KingDirector of Research at Rodman & RenshawYale JenManaging Director and Healthcare Equity Analyst at LaidlawPowered by Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Beyond Air Earnings HeadlinesBeyond Air Formalizes CEO Agreement, Boosts CFO CompensationSeptember 24, 2026 | tipranks.comBeyond Air consensus price target lowered by 33.33% to $20.40September 15, 2026 | msn.comThis list won't be up much longerBill Poulos and his team rebuild their Top 10 Stocks to Buy This Quarter report from scratch every quarter, pulling the old list down the moment a new one goes up. This quarter's edition is still available, but once the next list is published, it disappears for good. Normally priced at 29.97 dollars, it's currently free to download.October 6 at 1:00 AM | Profits Run (Ad)Lake Street initiates coverage of Beyond Air (XAIR) with buy recommendationSeptember 2, 2026 | msn.comBeyond Air to Participate in the 2026 Cantor Global Healthcare ConferenceSeptember 2, 2026 | globenewswire.comBeyond Air Receives FDA Breakthrough Device Designation For LungFit GO In NTM-PDAugust 31, 2026 | rttnews.comSee More Beyond Air Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Beyond Air? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Beyond Air and other key companies, straight to your email. Email Address About Beyond AirBeyond Air (NASDAQ:XAIR) is a medical device and biopharmaceutical company focused on developing nitric oxide (NO) therapies for respiratory conditions. The company’s technology is designed to generate nitric oxide from ambient air and deliver it directly to patients, potentially reducing the need for traditional high-pressure nitric oxide cylinders. Its primary platform, LungFit, includes systems intended to produce and administer nitric oxide at the point of care. LungFit PH is designed for use in hospitals to deliver nitric oxide to term and near-term newborns with hypoxic respiratory failure associated with pulmonary hypertension. Beyond Air has also been developing additional LungFit applications for other pulmonary conditions, including respiratory infections and pulmonary hypertension. Beyond Air serves the hospital and acute-care markets, primarily in the United States, while pursuing broader commercial and regulatory opportunities. The company is headquartered in Garden City, New York. 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PresentationSkip to Participants Operator00:00:00Good morning, and welcome everyone to Beyond Air Financial Results Call for the fiscal quarter ended December 31st, 2025. At this time, all participants are in listen-only mode. A question-and-answer session will follow the formal presentation. And now I'd like to turn the call over to Corey Davis of LifeSci Advisors. Please go ahead. Corey DavisManaging Director at LifeSci Advisors00:00:20Thank 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 third quarter of fiscal 2026, ended December 31st, 2025. A copy of this press release can be found on our website, 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 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. Corey DavisManaging Director at LifeSci Advisors00:01:06We 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 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 conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, February 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 Steve Lisi, Chief Executive Officer of Beyond Air. Steve, go ahead. Steve LisiCEO at Beyond Air00:01:57Thanks, Corey, and good morning to everyone. With me here today is Dan Moorhead, our new Chief Financial Officer. It has been a pleasure working with Dan over the past several months. He brings a proven track record as a proactive CFO with demonstrated success supporting commercial organizations through periods of rapid growth. I also look forward to his active engagement with the investment community as he becomes fully integrated into the role. Also joining us today is Bob Goodman, our Chief Commercial Officer. Bob assumed the role in October after previously joining Beyond Air as a board member back in June. Let me start my prepared remarks by saying just how pleased I am to speak with you today and provide an update on what has been a productive and meaningful period for our company. Steve LisiCEO at Beyond Air00:02:38We have achieved several significant milestones, strengthened our balance sheet to support continued commercial execution, and made a strategic decision to sell our Neuronas subsidiary in exchange for equity in the acquiring company and up to $32.5 million in upfront development and commercial milestone payments. We believe these recent events have strengthened our ability to execute our commercial strategy and create long-term value for our shareholders. Let me walk you through these updates in greater detail. Starting with our core business, revenue in the fiscal quarter increased 105% year-over-year to $2.2 million. This represents continued progress as we scale adoption and expand awareness of LungFit PH in clinical settings. We now support more than 45 hospitals across the United States and internationally that have adopted our first-generation LungFit PH system. Steve LisiCEO at Beyond Air00:03:26Customer feedback has been encouraging, with retention exceeding 90% and more than half of customers under multi-year agreements. We believe this installed base positions us well to support continued revenue growth from our first-generation system while preparing for the anticipated FDA decision for our second-generation system. Steve LisiCEO at Beyond Air00:03:42Our commercial team continues to refine its targeting strategy, prioritizing hospitals most likely to adopt our LungFit PH today and expand usage following approval of the second-generation system, which we expect to receive before the end of calendar 2026, subject to regulatory review and clearance. We are making steady progress building relationships with clinicians, administrators, and healthcare systems. Our current objective is to continue expanding Gen 1 system utilization through calendar 2026 in the U.S. and internationally, while preparing for the potential launch of our second-generation system once approved. Steve LisiCEO at Beyond Air00:04:18As previously discussed, Gen 2 system is designed to offer reduced size and weight, simplified operation, extended service intervals, improved backup system functionality, and very importantly, compatibility with both air and ground transport. We believe these enhancements will expand the addressable market relative to Gen 1 and support broader adoption over time. At this point, I'm going to pass the call over to Bob Goodman, who has made excellent progress since taking the reins as Chief Commercial Officer about four months ago. Bob? Bob GoodmanChief Commercial Officer at Beyond Air00:04:47Thanks, Steve, and let me begin by saying, I share Steve's enthusiasm about the opportunities ahead for Beyond Air. I as well believe that LungFit PH is the best-in-class nitric oxide solution globally. Feedback from U.S. customers and international partners on system performance and customer support have been extremely positive, providing a solid foundation for continuous growth. We have national group purchasing organization agreements with Premier and Vizient, which together provide access to nearly 3,000 hospitals across the United States. As awareness of LungFit PH increases, we expect additional opportunities at the GPO and integrated delivery network level in 2026. As previously announced, we have been working with TrillaMed to support our engagements with the federal healthcare systems. I am pleased to announce that together with this valued partner, we completed the first sale of LungFit PH to a VA Medical Center. Bob GoodmanChief Commercial Officer at Beyond Air00:05:46This initial commercial sale to the VA hospital system establishes an important foothold, opening potential pathways for future orders and broader adoption across the system, and provides access to the largest healthcare network in the United States. Internationally, we continue to see strong engagement from our distribution partners. Over the past several months, we've expanded our global LungFit PH distribution network with new agreements in Canada, Germany, Brazil, Austria, the Netherlands, and Sri Lanka, bringing total international coverage to 40 countries. As we broaden our global footprint, we are laying the groundwork for long-term growth and positioning Beyond Air to serve a significantly larger addressable market. It is important to note that we are live in a few hospitals with LungFit PH, and have already begun to see repeat orders for accessories from several countries. Bob GoodmanChief Commercial Officer at Beyond Air00:06:44Taken together, these commercial, operational, and strategic developments give me confidence in the trajectory of the business. What also gives me confidence are the people at Beyond Air. The dedication of this team is second to none, and I've been in this business for decades. This includes all the aspects of the team, from clinical support, to marketing, to customer service, to engineering, to finance, to regulatory, to quality, et cetera. Our people are fully engaged and dedicated to the vision of improving the lives of patients and medical staff with LungFit PH. Bob GoodmanChief Commercial Officer at Beyond Air00:07:19I also want to emphasize the advantages, as Steve mentioned earlier, on our second generation system. From my time spent with customers and potential customers in the United States, I believe that the Gen 2 system addresses everything on the wish list from clinicians in hospitals. I'm extremely confident that I, along with the team here, will execute on our vision of becoming the global nitric oxide leader. Now I'll turn things back over to Steve. Steve LisiCEO at Beyond Air00:07:45Thanks, Bob. Turning to Beyond Cancer, we recently announced that our abstract was selected for the 2026 AACR Annual Meeting, which is taking place from April 17th to 22nd in San Diego, California. As previously announced, the study enrolled 10 subjects at doses of 25,000 and 50,000 parts per million of nitric oxide gas, delivered over five minutes intratumorally. These patients all had metastatic disease and were heavily pretreated. All subjects had a life expectancy of less than 12 months. We have already reported that the safety profile observed to date is acceptable. The data presented at AACR will include updated overall survival data, for which median survival has not yet been reached as of October 1st, 2025. We remain dedicated to pursuing the phase I-B combination study with anti-PD-1 therapy, and we will communicate more details as we progress. Steve LisiCEO at Beyond Air00:08:39With respect to Neuronas, our neurology-focused subsidiary, on January 13th, 2026, XTL Biopharmaceuticals announced a binding letter of intent to acquire Neuronas in exchange for Beyond Air's approximately 85% ownership interest. Consideration includes a 19.9% stake in XTL, $1 million in cash, and milestone-based contingent payments totaling up to $31.5 million. Following closing, Neuronas is expected to serve as XTL's flagship platform for autism and neuro-oncology development. We believe this agreement provides the potential to create meaningful value for our shareholders by enabling Neuronas' pipeline to advance with dedicated focus and funding through XTL Bio. We will not provide additional commentary beyond public disclosures while the transaction remains pending. Steve LisiCEO at Beyond Air00:09:31To conclude, the $5 million financing completed in January 2026, together with the previously announced promissory note and equity line of credit for up to $32 million with Streeterville Capital that we announced in November 2025, provide resources to support commercial execution and readiness for the second-generation LungFit PH system. We remain focused on disciplined execution and delivering advanced nitric oxide solutions to clinicians and patients around the world. Now I will turn it over to our CFO, Dan Moorhead. Dan MoorheadCFO at Beyond Air00:10:01Thanks, Steve, and good morning, everyone. I'm excited to join my first call since being appointed CFO about seven weeks ago. I still have a lot to learn, but I'm incredibly impressed by what the team has achieved, not just over the past year, but even within the past few months. The progress has been extraordinary, and I see a bright future ahead as the team continues to execute on our growth strategy. Our financial results for the third quarter of fiscal year 2026, which ended December 31st, 2025, are as follows: Revenue for the fiscal quarter ended December 31st, 2025, increased 105% to $2.2 million, compared with $1.1 million for the fiscal quarter ended December 31, 2024. On a sequential basis, this represents a 21% increase compared with last quarter. Dan MoorheadCFO at Beyond Air00:11:00Gross profit increased to $300,000 for fiscal third quarter 2026, compared to a gross loss of $200,000 for the same period last year, and a gross loss of $300,000 in the prior quarter. Turning to operating expenses, we continue to see reductions across SG&A, R&D, and in our supply chain as a result of cost reduction initiatives taken in the past 12 months, as well as the decrease in R&D costs related to our Gen 2 device, which are mostly behind us since the PMA was filed with the FDA. Total operating expenses for the fiscal third quarter of 2026 were reduced to approximately $6.9 million, which is down from $10.7 million for the same period last year. Dan MoorheadCFO at Beyond Air00:11:54This translates to a 36% reduction year-over-year, and a greater than 60% reduction from the high of $17 million at its peak... Research and development expenses were $2.4 million for fiscal third quarter of 2026, as compared to $3 million for the same period last year. As I mentioned earlier, the year-over-year decrease was primarily driven by lower development costs associated with our Gen 2 device, with the remaining reduction attributable to a decrease in headcount and related costs. SG&A expenses for the quarters ended December 31st, 2025, and December 31st, 2024, were $4.5 million and $7.7 million, respectively, a decrease of 42% year-over-year. Almost all of the decrease of $3.3 million was from a reduction in employee-related costs. Dan MoorheadCFO at Beyond Air00:12:57Other expense was $1 million, compared to $2.4 million for the same period a year ago. The decrease in expense of $1.5 million was primarily attributed to the prior period loss associated with the extinguishment of debt of $1.9 million. Net loss attributed to common stockholders of Beyond Air was $7.3 million, or a loss of $0.85 per share, basic and diluted, compared with $13 million, or a loss of $2.96 per share, basic and diluted. Please note that the per share results for both periods were calculated to reflect the company's 1-for-20 reverse stock split, which became effective on July 14th, 2025. Net cash burn for the quarter was $4.3 million, which is a reduction of over 40% versus a year ago. Dan MoorheadCFO at Beyond Air00:13:58We believe our overall cash burn will continue to reduce as revenue grows and will only get better until we get approval and start building inventory in preparation for the launch of Gen 2. As of December 31st, 2025, we reported cash, cash equivalents, restricted cash, and marketable securities of $17.8 million. Subsequent to the end of the third quarter, we completed a $4.5 million dollar equity financing, net of issuance costs, and we believe this capital provides us with a cash runway into calendar year 2027 and potentially to profitability, provided we continue to hit our current revenue estimates and continue to control costs. With that, I'll hand the call back to Steve. Steve LisiCEO at Beyond Air00:14:53Thanks, Dan. Operator, we'll take questions now. Operator00:14:56Thank you. At this time, if you'd like to ask a question, please press star one from your telephone keypad and a confirmation tone will indicate your line is in the question queue. Let me press star two if you'd like to withdraw your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please, while we poll for our first question. Thank you. The first question comes from the line of Mike King with Rodman & Renshaw. Please proceed with your questions. Mike KingDirector of Research at Rodman & Renshaw00:15:26Thanks for taking the question. Good morning, guys. I have a couple of questions, if you don't mind. I just wonder if you could talk a little bit more about the sales process. I think it's a great breakthrough that you, you know, you've got sales into the VA system, or VA hospital, I should say. But it brings up the topic of the VA system, as you mentioned. How do you penetrate systems rather than a single hospital at a time? What needs to happen in terms of the sales process or the RFPs or things like that that can, you know, see us knocking off, you know, more than one healthcare facility at a time? Steve LisiCEO at Beyond Air00:16:14Yeah, Mike. Thanks for the question. Yeah, go ahead, Bob, you take this one. Bob GoodmanChief Commercial Officer at Beyond Air00:16:19Yeah, sure. And then, then you can definitely provide any color you like, Steve. Thank you. Yeah. So, Mike, yeah, with the VA system, we're, we're on, as, as you know, and, our product is being offered through the ECAT system. So that catalog, actually, makes it an easier approach for our customers to get to us directly. It's outside of an RFP process, but we're still. Mike KingDirector of Research at Rodman & Renshaw00:16:40Oh, it is. Bob GoodmanChief Commercial Officer at Beyond Air00:16:42Yeah, we're still able to actually compete with other RFPs that come out through. You know, there's a couple of different ways that the VAs, you know, contract with vendors. But yeah, we have access that way, so it's great. Mike KingDirector of Research at Rodman & Renshaw00:16:56Okay. And in your formal comments, you mentioned words to the effect that you're identifying facilities most likely to acquire, you know, the system. How do you or can you say how you identify them and, you know, maybe help us understand how you're targeting those facilities? Bob GoodmanChief Commercial Officer at Beyond Air00:17:18Yeah. So we've done a really good job standing up our commercial organization, both in the U.S. and internationally. And right now what we're doing is we're focusing, and not to say an overhaul, but more of an exactness with our people and our process and our technology. So you know, different prospecting tools with good intelligence and good CRM rigor to follow up with the customers and taking the process of, you know, real good demand generation, where we're getting top of the funnel looks at our customers. Bob GoodmanChief Commercial Officer at Beyond Air00:17:48Having really good pipeline discipline so we could get in front of the right customers and then to have our people, the people part of it, you know, in the right places at the right time, with the right coverage. So we have that right, you know, reach and frequency, getting in front of these customers and just getting in front of more and more. So we have that, that touch. So, so yeah, we've been really refining that and, and the customers are really responding well for our ability to get in front of them. Mike KingDirector of Research at Rodman & Renshaw00:18:14Well, that's great. Has there been any appreciable change in the length of the sales cycle? Bob GoodmanChief Commercial Officer at Beyond Air00:18:22Yeah, I mean, that, that pretty much, Mike, still remains the same. At, at the real front end, you know, if you get kind of real lucky based off of, you know, the timing of a contract that might be expiring and, and that customer is really, really organized, and you can knock out a real quick demo and evaluation, you can do that in that four or five month time frame. But it's really in that right around six to nine months, and it could be longer. But, but what we're doing is a good job, you know, identifying, the customers and, and again, you know, reaching out to them and finding out where they're at with their contract and making sure that they see the value of our product. Bob GoodmanChief Commercial Officer at Beyond Air00:18:57And with that, you know, we're hoping that might, you know, restrict things just a bit. But we're really organized, and our clinical teams are out there in the field with our sales teams to make sure that we're in front of them as early as possible. Mike KingDirector of Research at Rodman & Renshaw00:19:11Okay. And I apologize, one more quick one. How do you segment or can you segment the next gen system so that, you know. This is typical of a lot of businesses where, you know, a next generation chip, let's say, is coming out or something and, you know, the sales cycle kind of, you know, concertina effect, where, you know, the purchaser may hold off until the next gen system is available. Is that a concern, or are you, you know, segmenting a different market with the new system? Thank you. Bob GoodmanChief Commercial Officer at Beyond Air00:19:49Yeah. So we're focusing right now, as you'd expect, on our first generation product, and it's been really well received, the version 24 of gen one. So, and we're focusing on the non-transport systems, okay? And we're being really well received there as there's natural conversations within the market for the transportation systems. That's a later on gen two conversation, and we're really kind of breaking away from those conversations, but being aware that these are, you know, systems that are gonna, you know, want to be working with us in the future. Mike KingDirector of Research at Rodman & Renshaw00:20:24Okay. All right. Thanks for indulging me, guys. Bob GoodmanChief Commercial Officer at Beyond Air00:20:27You got it. Steve LisiCEO at Beyond Air00:20:28Thanks, Mike. Operator00:20:30The next question is in the line of Marie Thibault with BTIG. Please just proceed with your question. Marie ThibaultManaging Director at BTIG00:20:36Good morning. Thanks for taking the questions, and welcome, Bob and Dan. Wanted to quickly just check in on anything, any communications you've been having with the FDA on the gen two process to speak to your confidence in the timeline. I think you said by end of calendar year. And then what will be needed to do post-clearance in terms of building inventory, kind of a timeline we might think about before you can go into a formal launch and ramp? Steve LisiCEO at Beyond Air00:21:03Okay. Thanks, Marie. Well, I'll comment on the FDA side. So we've been having fairly constant communication with FDA, and, you know, we're very happy with the interaction. You know, we don't really see any major hurdles. Everything the FDA has asked for, we'll provide them. Shouldn't be a problem. And I'm sure there'll be the process will continue with FDA, and we'll continue to answer the questions as we go forward. You know, we still are waiting on the work to be completed with our contract manufacturer so we can be inspected. And that's essentially, in our minds, what the gating factor will be from a timing perspective. So we feel highly confident in the timelines that we provided, given the state of affairs today. I don't know if I- Marie ThibaultManaging Director at BTIG00:21:54All right. Steve LisiCEO at Beyond Air00:21:55Gave you the answer you needed. Marie ThibaultManaging Director at BTIG00:21:55No, that- Steve LisiCEO at Beyond Air00:21:56If there's other things you want to ask. Marie ThibaultManaging Director at BTIG00:21:57Yeah, yeah. That's great to hear. Thank you for that, Steve. And then I guess I'll ask a quick follow-up here on the international side. I know you've got some great partnerships and some efforts going on there. So any wins or any catalysts to think about on the international side? And thanks for taking the questions. Steve LisiCEO at Beyond Air00:22:13Sure. Bob, you want to take the international question? Bob GoodmanChief Commercial Officer at Beyond Air00:22:16Yeah, sure. So we have had some recent wins, which is great. I think, as you know from the past calls, it was all about setting up and getting our distributors armed with our demo devices so they can get in front of the systems. But then there's the whole part of the process with whether it's Europe or Middle East or Australia, where it's mostly tenders, compared to the U.K. or Portugal, where there's, you know, a natural, you know, a national frame or, you know, you get that hunting license like Germany and APAC, where you can go direct. So with all those different regions, yeah, we've had wins. And on top of having wins, we're now actually seeing customers reorder filters. So, you know, the product is being deployed into hospitals now, which is great, and we're starting to again get that stickiness, so it's fantastic. Marie ThibaultManaging Director at BTIG00:23:05All right. Thank you so much. Bob GoodmanChief Commercial Officer at Beyond Air00:23:07Yeah. Steve LisiCEO at Beyond Air00:23:08Thanks, Marie. Operator00:23:10Our next question is from the line of Justin Walsh with JonesTrading. Please proceed with your question. Justin WalshDirector of Healthcare at JonesTrading00:23:16Hi, thanks for taking the question. Wondering if you can provide any color on what attracted XTL Biopharmaceuticals to be interested in the Neuronas opportunity, and then how, I guess, collaboration or working with them will look going forward, given that you still have a stake in that company? Steve LisiCEO at Beyond Air00:23:36Well, thanks for the question. So, yeah, Justin, look, you know, XTL was, you know, was, you know, a company looking for an asset, and there were multiple, choices for them. I think what excited them about this opportunity is the science. I mean, there's been two, two papers, landmark papers, published about the work done by, Dr. Amal, who's the scientist, you know, and the innovator behind this, this approach to treating autism as, as well as, glioblastoma. I just want people to recognize that the, the functions of nitric oxide in the brain are, are numerous. So I think that's what, what attracted them to this. There's a clear path to human studies. Steve LisiCEO at Beyond Air00:24:23I think a lot of the work that's been done by the Neuronas team has given that clarity to anybody who's taken a look under the hood. So I think it's just a matter of you know, providing the FDA what they require, which is pretty straightforward. It's just a matter of getting that work done. So with XTL coming up with funding, they'll be able to bring this into humans. So I think the attractiveness was great science, clear path to human trials, and as everyone on this call probably knows, you know, translating efficacy from rodents to humans is something that's difficult to predict, but we'll find out, and I think that's what attracted them. We're going to get there and do that study and figure out if the efficacy translates. Steve LisiCEO at Beyond Air00:25:10If it does, you know, we're looking at a potential treatment for autism and glioblastoma at this point. It's very exciting. Just a little bit early for Beyond Air to maintain and fund. This is why the transaction was done, and we're very happy that a lot of this transaction for Beyond Air is us getting a 20% stake in the new entity. That's the confidence we have that this is going to be in human trials. We have confidence on the safety side for sure, and the efficacy side, we'll see what happens. Justin WalshDirector of Healthcare at JonesTrading00:25:49Got it. Thanks. Steve LisiCEO at Beyond Air00:25:50Thanks. Operator00:25:53The next question is from the line of Jason Kolbert with Dawson James Capital. Please proceed with your questions. Jason KolbertDirector of Research at Dawson James Capital00:25:59Good morning, guys. Can we talk a little bit about COGS and how COGS performed in the quarter? Over the next couple of years, what do you think a sustainable COGS is? Steve LisiCEO at Beyond Air00:26:15Dan, you wanna take that one? Dan MoorheadCFO at Beyond Air00:26:19Sure. You know, we tend to see Gen 1, you know, again, we think we're in the, and Steve can help me on this. I'm still pretty new on it, but, you know, we expect COGS long term as we get to scale, you know, in the 60% range and, and moving up towards 70 with the Gen 2 product. But in the near term, again, with, with revenue levels growing, but growing at a more moderate pace until we hit the Gen 2 launch, again, I think you're gonna see it pretty close to that, what you saw in Q3 and continue to grow from there. But, long term, I think that gives you a little profile, and I'm guessing you guys have possibly talked about that in the past as well. Jason KolbertDirector of Research at Dawson James Capital00:27:07And just to follow- Steve LisiCEO at Beyond Air00:27:09Just follow up on what Dan said, if you don't mind. You know, so, yeah, I think, I think Dan's right in, in what he says, but I, I would... You know, there are a couple of factors and like Dan said, he's barely two months in. There are a couple of factors that we're still trying to figure out with respect to the, to the margin on, and that would be from a pricing side of the market. Steve LisiCEO at Beyond Air00:27:28So I think, you know, that goal of 70% with the Gen 2 is a great goal. That's the target. You know, if it's 65, it's 65, you know, that's not the end of the world for us, but I think that's our target, and I think we'd like to hit it. You know, target with gen one would be to get close to 60, but again, I, I think a gen one is more of a 50s type thing. But again, it's, it's gonna depend on how the price shakes out in the market at the end of the day. And you know, that remains to be seen. Jason KolbertDirector of Research at Dawson James Capital00:27:59Okay. Steve LisiCEO at Beyond Air00:27:59You had a follow-up, Jason, go ahead. Jason KolbertDirector of Research at Dawson James Capital00:28:02Yeah. Very helpful. Can you talk also about SG&A and how sensitive the sales cycle would be to, you know, increasing SG&A, hiring additional salespeople? You know, how does that impact kind of revenues? What I'm trying to do is get a handle on, you know, more capital deployed in SG&A, does that translate into more revenues? Steve LisiCEO at Beyond Air00:28:30Well, Jason, I mean, you know, you got. Operator00:28:33Thank you. The next question is from the line of Yale Jen with Laidlaw. Please proceed with your question. Yale JenManaging Director and Healthcare Equity Analyst at Laidlaw00:29:05Good morning, and thanks for taking the questions. Just in the press release, you mentioned, you mentioned that for the Gen 2, there has the potential of extending the service intervals. Could you elaborate a little bit more on that specific aspect? Hello, can you hear me? Steve LisiCEO at Beyond Air00:29:33Hello? Operator00:29:37Hey, your line is live for a question. Please go ahead. Steve LisiCEO at Beyond Air00:29:43Are you with us? Yale JenManaging Director and Healthcare Equity Analyst at Laidlaw00:29:45Yes, I am. Operator00:29:49Thank you. Yale JenManaging Director and Healthcare Equity Analyst at Laidlaw00:29:49Hello, can you hear me? Operator00:29:51Please stand by, ladies and gentlemen. We're experiencing technical difficulties. Our conference will resume momentarily. Thank you. Please remain on the line. Our conference will resume momentarily. Please remain on line, ladies and gentlemen, our call will resume momentarily. Thank you. Steve, you're now reconnected. Please continue. Caller, please go ahead with your question. Yale JenManaging Director and Healthcare Equity Analyst at Laidlaw00:31:11Sure. Thanks. Hey, Steve. Thanks for taking the questions. I believe in the press release you mentioned that the second gen will have the potential of extending the service intervals. Could you elaborate a little bit more specifically on this particular aspect? And then I have a follow-up. Steve LisiCEO at Beyond Air00:31:31Yeah, thanks. Yeah, thanks, Yale. Appreciate that question. So the current, the current system, the first generation system, every 1,000 hours, we need to bring it in for service. So that, that can be, you know, that can, it could be a slight disruption for the hospital if they're using, you know, a couple 1,000 hours a year per machine, so we might be in there every six months, rotating machines. So it, it, it's a smooth process, but it's an expensive process for us, right? So we just come in, drop them a new machine and pick that one up and bring it in for service. So it's not very frequent, but, you know, it's, it's something we'd like to improve upon. Steve LisiCEO at Beyond Air00:32:14So with the second generation machine, you know, we think that service interval will be pushed out to at least 3,000 hours before we need, and potentially longer. So testing is still going on. We haven't reached that juncture yet where the reliability testing that we're doing has stopped. So it's still ongoing. So we're past the 3,000-hour mark at this point, which means, you know, it's at least 3 times longer before we have to go in. So if we were going in every, at a hospital, let's say we're going in every 10 months, now we're going in every 30 months on average before we have to swap out the machine. Steve LisiCEO at Beyond Air00:32:49So that's, it's certainly better for the hospital, from that standpoint, although I don't think the swap outs are really a problem for them because our team does a great job, and it runs so smooth. But from a gross margin perspective, I think that's the impact that you heard about earlier on a question when Dan and I were responding to the gross margins between Gen 1 and Gen 2. Yale JenManaging Director and Healthcare Equity Analyst at Laidlaw00:33:12Okay, great. And maybe just attach on that to this one a little bit, which is that would this be needed? You mentioned you're still testing for maybe even longer, so, you know, interval for the service needed. Would that be required before you you know, submit or for the gen two review, or that's something that could be the gen two review without the without having this particular aspect? Steve LisiCEO at Beyond Air00:33:44No, this is so there is a reliability hurdle with FDA. We've already passed that hurdle, so anything that we get is just more of a, you know, a guide for us for service with our customers. That's really what it is. So it's not a gating factor for FDA approval. Yale JenManaging Director and Healthcare Equity Analyst at Laidlaw00:34:08Okay, great. Maybe it's one more question. So on the oncology side, that since you guys already have a little bit more cash in hand, should we think about the phase II, phase I-B study potentially to start later this calendar year? And thanks. Steve LisiCEO at Beyond Air00:34:30Well, I don't know when it will start, Yale. We're certainly speaking with people and looking at that, so I don't want to commit to a timeline at this point. You know, while we do have a nice balance sheet at this moment in time, I think we need to focus the balance sheet on the commercial operations at this point. So it would probably not be something that Beyond Air would commit to fully fund a study like that. Maybe once we are more comfortable with our path to profitability, that could be a different conversation that we have internally. Yale JenManaging Director and Healthcare Equity Analyst at Laidlaw00:35:14Okay, great. That's very helpful, and congrats on the good quarter in terms of the top line. Steve LisiCEO at Beyond Air00:35:21Great. Thanks, Yale. Operator00:35:25Thank you. At this time, we are showing no further questions in the queue, and this concludes our question and answer session. I would now like to turn the call back over to Steve Lisi for any closing remarks. Steve LisiCEO at Beyond Air00:35:35I'd like to thank everybody for dialing in today. Bye-bye. Operator00:35:41Thanks, everyone, for their time today. You may now disconnect your lines at this time, and have a wonderful day.Read moreParticipantsExecutivesBob GoodmanChief Commercial OfficerDan MoorheadCFOSteve LisiCEOAnalystsCorey DavisManaging Director at LifeSci AdvisorsJason KolbertDirector of Research at Dawson James CapitalJustin WalshDirector of Healthcare at JonesTradingMarie ThibaultManaging Director at BTIGMike KingDirector of Research at Rodman & RenshawYale JenManaging Director and Healthcare Equity Analyst at LaidlawPowered by