NASDAQ:XAIR Beyond Air Q2 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-$25.00Consensus EPS -$22.00Beat/MissMissed by -$3.00One Year Ago EPSN/ABeyond Air Revenue ResultsActual Revenue$1.82 millionExpected Revenue$2.54 millionBeat/MissMissed by -$718.00 thousandYoY Revenue GrowthN/ABeyond Air Announcement DetailsQuarterQ2 2026Date11/10/2025TimeAfter Market ClosesConference Call DateMonday, November 10, 2025Conference Call Time4:30PM 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 Q2 2026 Earnings Call TranscriptProvided by QuartrNovember 10, 2025ShareShareShare This ReportLink copied to clipboard.Key Takeaways Positive Sentiment: Commercial traction accelerated — revenue rose 128% year‑over‑year to $1.8M (Q2 FY26) and management reaffirmed a raised FY26 revenue guide of $8–$10M, though sequential growth was flat due to timing of hospital purchases. Positive Sentiment: Balance sheet bolstered — closed a $12M promissory note and established a $20M equity line with Streeterville Capital, and reported $10.7M cash and securities, which management says provides runway into calendar 2027 to support commercial expansion and prepare for Gen‑2. Positive Sentiment: Commercial expansion and product roadmap — added Premier and Vizient GPO coverage (~3,000 hospitals), expanded distribution to 35 countries with first international commercial placement, launched a capital purchase model (first U.S. buy), and expects a smaller, transportable Gen‑2 LungFit PH launch in late 2026 (pending FDA). Negative Sentiment: Profitability and cash dynamics remain challenged — reported a Q2 net loss of $7.9M (loss per share $1.25) and a $0.3M gross loss due to device upgrade costs and inventory provisions, with net cash burn of $4.7M for the quarter despite marked year‑over‑year expense reductions. Positive Sentiment: Clinical pipeline progress — Beyond Cancer’s UNO Phase 1A (n=10) shows a median survival not yet reached (current median ~22 months) with a clean safety profile so far, and Neuronas programs BA‑101 and BA‑102 received FDA orphan designations, supporting longer‑term upside. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallBeyond Air Q2 202600:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Operator00:00:00Good afternoon and welcome to the Beyond Air Financial Results Call for the fiscal quarter ended September 30th, 2025. At this time, participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. I would like to turn the call over to Garth Russell, LifeSci Advisors. Please go ahead. Garth RussellManaging Director of Corporate Communications at LifeSci Advisors00:00:20Thank you, Operator. Good afternoon, everyone, and thank you for joining us. Today, after market close, we issued a press release announcing the operational highlights and financial results for Beyond Air's second quarter of fiscal year 2026 ended September 30th, 2025. A copy of this press release can be found on our website, www.beyondair.net, under the News and Events section. Before we begin, I would like to remind everyone that we will be making comments and various remarks about 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. Garth RussellManaging Director of Corporate Communications at LifeSci Advisors00:01:12We 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, www.beyondair.net. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, November 10th, 2025. Beyond Air undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call. Garth RussellManaging Director of Corporate Communications at LifeSci Advisors00:01:58With that, I'll turn the call over to Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. Steve? Steven LisiChairman and CEO at Beyond Air00:02:06Thanks, Garth, and good afternoon to everyone. With me here today is Doug Larson, our Chief Financial Officer. We continue to receive highly encouraging feedback from hospitals using LungFit PH, reinforcing the clinical value and operations efficiency our technology delivers. Adoption has accelerated meaningfully over the past year, contributing to a 128% year-over-year revenue increase in the fiscal second quarter, reaching $1.8 million, up from $0.8 million for the same period last year. While we are pleased by the strong year-over-year growth, sequential growth was essentially flat compared to the prior quarter, reflecting the timing of hospital purchasing cycles and the natural variability in international shipments. We view this stability as an encouraging baseline from which we expect sequential growth to resume over the coming quarters. We continue to navigate the inherent complexity of hospital sales cycles in the U.S. and internationally. Steven LisiChairman and CEO at Beyond Air00:03:01These extended lead times and institutional decision-making processes have led to peaks and valleys in our quarterly sales performance, as seen in the September quarter. Importantly, our sales pipeline remains robust, and we see substantial greenfield opportunities across the U.S. as awareness and interest in LungFit PH continue to build. Before getting into further details, let me highlight the changes that have occurred since our last update in August. We have raised $12 million in debt and will file a registration statement for an additional $20 million through an equity line of credit, both with Streeterville Capital, which solidifies our balance sheet. We believe these additional funds will give us the ability to properly address the pace of sales growth with our first-generation system and prepare for the launch of our second-generation system. LungFit PH has been placed in the first hospital outside the United States for commercial use. Steven LisiChairman and CEO at Beyond Air00:03:55We have named our board member, Bob Goodman, as interim Chief Commercial Officer given the departure of David Webster. We are updating our fiscal year 2026 guidance to $8-$10 million. We introduced our capital purchase sales model in the United States and had our first hospital purchase of LungFit PH. We collected data from Beyond Cancer's phase I-A trial of 10 subjects with ultra-high concentration nitric oxide, or UNO. That shows median survival has not yet been achieved and currently sits at 22 months. These updates have put us in a very strong position and provide us the financial runway we need to optimize the Gen 2 launch in late calendar 2026 and drive our international business from the strong foundation we have already built. As you all know, we were awarded a national group purchasing agreement for therapeutic gases with Premier. Steven LisiChairman and CEO at Beyond Air00:04:52Coupled with our agreement with Vizient, we now have access to nearly 3,000 hospitals. We are confident that our targeted commercial strategy, supported by the right people now in place and strengthened by our Premier and Vizient GPO contracts, will begin to have a meaningful impact on revenue over the coming quarters. Our disciplined approach is allowing us to prioritize the highest-value hospital opportunities while deepening relationships across our existing accounts. This focused execution is already translating into broader market engagement and increased visibility of LungFit PH within key hospital systems. At the same time, we are preparing for the next major inflection point with our second-generation LungFit system, which is smaller, lighter, and designed for both air and ground transportation while maintaining all the revolutionary features of the first-generation LungFit PH. Steven LisiChairman and CEO at Beyond Air00:05:43We believe this next-generation platform will enable us to expand into larger hospitals and health systems, further accelerating adoption and cementing LungFit's position as the standard for nitric oxide delivery. We anticipate commercial launch of the second-generation system in the U.S. market in late calendar year 2026, pending FDA approval. As a significant aside, several of our existing customers have extended their annual contracts with multi-year agreements while increasing anticipated annual volumes. We see this as confirmation of the ease of use and the value proposition of LungFit PH, and we expect this trend to continue. During the quarter, we finalized and have since launched a new sales model that complements the traditional industry leasing model. Under this new approach, hospitals may now purchase LungFit PH systems outright while continuing to generate recurring revenue for Beyond Air through disposables and service agreements. Steven LisiChairman and CEO at Beyond Air00:06:42Initial system sales occurred subsequent to quarter-end, and the early reception has been extremely positive. We are very excited by the flexibility this dual-model approach offers and the opportunity it creates to accelerate adoption of LungFit PH. Today, we announced the appointment of Bob Goodman as interim Chief Commercial Officer following the departure of David Webster. Bob joined the Beyond Air board earlier this year and brings deep commercial and operational expertise from leadership roles at Biotelemetry, Philips Healthcare, Cardiocore, Thermo Fisher Scientific, and Pfizer. His experience spans public companies, private equity-backed businesses, and early-stage ventures, where he has consistently driven innovation, operational scale, and commercial success. We have greatly valued his contributions to the board and look forward to the fresh perspective and leadership he brings as we ramp up commercial activities and, as I just mentioned, prepare for the highly anticipated launch of our second-generation LungFit PH. Steven LisiChairman and CEO at Beyond Air00:07:42A key driver of our long-term growth strategy over the past year has focused on the expansion of our global distribution network. During the September quarter, we added new distribution partnerships in Japan, South Korea, Mexico, Costa Rica, Guatemala, Panama, and El Salvador. These new agreements significantly broaden our geographic reach and demonstrate growing demand from both mature and emerging healthcare markets seeking modern, cylinder-free nitric oxide delivery solutions. Importantly, we achieved our first international commercial placement of LungFit PH into hospitals outside the United States this quarter. These initial system sales mark a key validation of our technology's global applicability and confirm that our value proposition—improved safety, reduced logistical burden, and long-term cost savings—is resonating strongly with hospital administrators and clinicians. We continue to see excellent engagement from our distribution partners, who are now actively seeking regulatory approvals or demonstrating LungFit PH in hospitals in their local markets. Steven LisiChairman and CEO at Beyond Air00:08:42These latest agreements bring our total international coverage to 35 countries, representing a combined population of approximately 2.8 billion people, and we expect to reach our goal of 60 countries under partnership in calendar 2026. As local distributors begin converting opportunities into active installations and sales, we anticipate international revenue contribution to build steadily through fiscal 2026, with momentum accelerating into fiscal 2027. This growing global footprint positions Beyond Air to capitalize on significant untapped demand for LungFit PH and lays the foundation for broader global adoption following additional regional approvals. To wrap up our remarks around LungFit PH, I have two more positive updates to share. Steven LisiChairman and CEO at Beyond Air00:09:27We had a patent allowance for a design patent that covers our second-generation LungFit PH through 2040, and we had data shown by a physician at the Extracorporeal Life Support Organization conference in September, which showed positive results when LungFit was used in the ECMO sweet gas circuit on neonates. I would like to provide an update on the data from Beyond Cancer's phase I-A study. As a reminder, the study enrolled 10 subjects at doses of 25,000 and 50,000 parts per million nitric oxide gas, delivered over five minutes intratumorally. These patients all had metastatic disease and were heavily pretreated. The mean number of total prior surgeries, radiation, and medications was 10.3, with a minimum of 4, maximum of 18. The mean number of all prior medications only was 5.5, with a minimum of 2 and a maximum of 14. Steven LisiChairman and CEO at Beyond Air00:10:23All subjects had a life expectancy of less than 12 months when we treated with UNO therapy. The only adverse event which occurred in one patient that was possibly attributable to nitric oxide was a grade 3 vasovagal response. Otherwise, the safety profile is very clean for this patient population. With respect to overall survival, the median and mean are 22 months and 21.2 months, respectively. These survival numbers will continue to increase, but we have not yet reached the final median survival. Given these impressive data, we are assessing the best path forward for the program at this time. 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. With respect to Neuronas, we recently announced that the U.S. FDA granted orphan drug designation to its investigational therapy, BA-101, for the treatment of glioblastoma. Steven LisiChairman and CEO at Beyond Air00:11:20The Neuronas team is working closely with regulators, investigators, patient groups, and foundations to accelerate development of BA-101 towards a first-in-human study. This program is in addition to the development for BA-102, an investigational therapy for the treatment of Phelan-McDermid Syndrome, or PMS, a syndrome associated with autism. We expect the IND submission for the first-in-human study by the end of calendar 2026. As a reminder, the FDA has also granted orphan drug designation to BA-102 for PMS. Steven LisiChairman and CEO at Beyond Air00:11:54I will wrap up by stating how energized we are following the financing, which will support the continued progress of our global commercial activities and help us prepare for the potential launch of the second-generation LungFit PH. The promise of LungFit is apparent, and we are thankful to the team at Streeterville for taking the time to appreciate our vision to provide clinicians and patients around the world with the optimal NO system. Steven LisiChairman and CEO at Beyond Air00:12:17Now, I will turn it over to our CFO, Doug Larson. Douglas LarsonCFO at Beyond Air00:12:20Thanks, Steve, and good afternoon, everyone. Our financial results for the second quarter of fiscal year 2026, which ended September 30th, 2025, are as follows. Revenue for the fiscal quarter ended September 30th, 2025, increased 128% to $1.8 million, compared with $0.8 million for the fiscal year ended September 30th, 2024. We showed 3% growth versus last quarter. Steve mentioned how our revenue is a little chunkier now, given an international ramp is never straight up. Douglas LarsonCFO at Beyond Air00:12:54We are showing a gross loss of $0.3 million for the fiscal second quarter 2026, compared to a loss of $1.1 million for the same period last year. The improvement was primarily attributed to sales growth. Our margins slipped back negative this quarter due to costs required to upgrade our existing fleet of devices and provisions for excess inventory. Turning to operating expenses, we continue to see cost reduction across the board, in SG&A, R&D, and in our supply chain due to cost reduction initiatives we took in the last 12 months. For the second quarter of fiscal 2026, we reduced total operating expenses to just above $7.4 million from $11.7 million for the same period last year. This translates to a 37% reduction year over year and greater than 56% reduction from a high of $17 million at its peak. Douglas LarsonCFO at Beyond Air00:13:47Going forward, we anticipate R&D expenses will decrease slightly next quarter as the costs related to our Gen 2 device are mostly behind us. SG&A expenses will only move up in line with our commercial performance to maintain our excellence in service and take advantage of coming opportunities. Research and development expenses were $2.5 million for fiscal quarter 2026, compared to $4.6 million for the same period last year. Half of the decrease of $2.1 million was due to a reduction in development costs for our Gen 2 device, while the other half was mostly attributed to a decrease in salaries and stock-based compensation costs. SG&A expenses for the quarters ended September 30, 2025, and September 30, 2024, were $4.9 million and $7.2 million, respectively. Almost all of the decrease of $2.3 million was from a reduction in salaries and stock-based compensation costs. Douglas LarsonCFO at Beyond Air00:14:44Only part of the business that saw an increase in SG&A was in Neuronas, as they start to build a little bit of infrastructure to support the groundbreaking work being done there. Other expense was $0.6 million, compared to a $1.2 million expense for the same period a year ago. The decrease in expense of $0.6 million was primarily attributed to the prior period loss associated with the partial extinguishment of debt. Net loss attributed to common stockholders of Beyond Air was $7.9 million, or a loss of $1.25 per share, basic and diluted. Our net loss for the fiscal quarter ended September 30th, 2024, was $13.4 million, or a loss of $5.67 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. Douglas LarsonCFO at Beyond Air00:15:43Net cash burn for the quarter was $4.7 million, which is a 66% reduction versus a year ago. We 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 September 30th, 2025, we reported cash, cash equivalents, and marketable securities of $10.7 million. As Steve mentioned earlier, subsequent to the end of the second quarter, we announced closing a strategic financial agreement with Streeterville Capital. Under the terms of the agreement, we issued a $12 million promissory note bearing a 15% annual interest rate. This note matures in 24 months from the issue date, with no payments due for the first 12 months. Douglas LarsonCFO at Beyond Air00:16:32In addition, we entered into a $20 million equity line of credit agreement with Streeterville Capital, dependent on our filing an S1 resale registration covering resale of the shares Streeterville Capital may receive under the ELOC. This ELOC provides us with the right, but not the obligation, to sell up to $20 million of newly issued shares of our common stock over a 24-month period, subject to certain limitations. Following these recent financing agreements, we believe that our cash and existing financial vehicles will be sufficient to allow us to support our current operating plans well into calendar 2027 and potentially to profitability, providing we continue to hit our current revenue estimates and continue to control costs at Beyond Air. Douglas LarsonCFO at Beyond Air00:17:15With that, I'll hand the call back to Steve. Steven LisiChairman and CEO at Beyond Air00:17:18Thanks, Doug. Operator will take questions. Operator00:17:24Okay. Thank you. We will now be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we pull for questions. Operator00:17:48The first question is from Justin Walsh from JonesTrading. Please go ahead. Justin WalshBiotech Equity Research Analyst at JonesTrading00:17:55Hi. Thanks for taking the questions. Without going into specific fiscal 2027 guidance, can you comment on the expected growth drivers leading into the potential approval of the second-generation LungFit PH, and then how you're thinking about that trajectory after that second-gen product is out? Steven LisiChairman and CEO at Beyond Air00:18:15Thanks, Justin. Appreciate that. Obviously, the trajectory once the second generation is out should be significantly steeper than what we're seeing now. That's our belief. I think people know the attributes of that system versus the current system and the current competition, so we're confident in that. As for the growth drivers prior to that, I assume you're asking for? Justin WalshBiotech Equity Research Analyst at JonesTrading00:18:44Yes. Steven LisiChairman and CEO at Beyond Air00:18:46Yeah. We're setting up internationally. We're in 35 countries now with partners. We did just place systems in our first commercial hospital outside the U.S. It takes time to build that. We always would go a little faster, but it is being built, and our international team is doing a great job. We've got a lot of seeds planted out there, I guess you could say. Steven LisiChairman and CEO at Beyond Air00:19:10We anticipate that with fiscal 2027 coming up, we should be winning a lot of hospitals outside the United States where the competition is a little bit different than it is in the United States. That is one of the drivers for 2027. The other thing inside the United States, we did introduce a capital purchase model. Our system is now to a point where it is extremely reliable. We have had interest, and we have actually had our first hospital purchase from us. Steven LisiChairman and CEO at Beyond Air00:19:47That would be a capital equipment purchase, and then the filter and the other accessories would be the ongoing purchase. Those prices, I guess it depends on how much nitric oxide you use in your hospital per year per system, but this is certainly very competitive from a per-hour cost basis for nitric oxide. I think this new offering in terms of how hospitals can pay in the United States, we've gotten some interest there, and the XUS will be the driver prior to Gen 2 being approved. Justin WalshBiotech Equity Research Analyst at JonesTrading00:20:21Got it. One more question. You mentioned here that you're hoping to commercialize the second-gen LungFit PH around end of calendar 2026, if I heard correctly. I'm just wondering if you can comment on kind of the thinking around this timing and whether or not you've noticed any delays in your dealings with the FDA recently. Steven LisiChairman and CEO at Beyond Air00:20:41Yeah. I think FDA is doing a great job. I don't think the timing that we're providing is FDA being the limiting factor. It's more supply chain on our side. I think the environment is difficult to get the parts that we need. Sodium doesn't help with all the disagreements, I would say, that are happening around the world with trade. Government shutdown doesn't help either. I think just getting things in place for our ability to get our contract manufacturer in shape for inspection is what we're doing. Steven LisiChairman and CEO at Beyond Air00:21:20It's just a matter of time before that occurs. I did mention, I mean, you did mention we'd be launching before the end of the year. I think approval has to be a little bit earlier than December, obviously, for us to be able to launch by then. We're not going to launch the next day. It's going to take a little bit of time. That's kind of where we are right now. Things can change. Things can be better or worse in terms of timing. As we sit here today, that's the feeling that we have. Justin WalshBiotech Equity Research Analyst at JonesTrading00:21:49Got it. Thanks for taking the questions. Operator00:21:56The next question is from Yale Jen from Laidlaw & Company. Please go ahead. Yale JenSenior Biotech Equity Research Analyst at Laidlaw & Company00:21:59Good afternoon, and thanks for taking the questions. Steve, could you just do some comparison between the new, this model versus the prior ones? Give us a little bit more deep dive in terms of the benefits to the company, maybe for the market penetration. I have a follow-up. Steven LisiChairman and CEO at Beyond Air00:22:22Yeah. Thanks, Yale. I mean, the biggest difference, well, there are a few, but the biggest differences are the size. This second-generation machine will be about 60% the size of the original. It will be what we've applied for. I believe we believe that upon approval, with approval from FDA, it would be approved for use in ground and air transportation. That's critical. I think that's probably the biggest difference maker for us. Steven LisiChairman and CEO at Beyond Air00:22:54The user interface has been upgraded based on feedback from our current customers and some future customers, I guess, who were not using our Gen 1 system but did give us advice on Gen 2. We listened to them, and we built this device based on their input. We think that all of the functions of the device will be a little bit easier and a little bit better for the user. Steven LisiChairman and CEO at Beyond Air00:23:21One other thing that we have is that the maintenance interval will be longer so that the disruption of swapping machines out for those high-volume users will be a thing of the past, let's say. When you have hospitals that are using an exceptional amount of hours per system per year, let's say, way above what the average is, we are bringing them in for maintenance fairly regularly. That's a little bit of a disruption at the hospital, and we're working to get Gen 2 out there, so that disappears. Yale JenSenior Biotech Equity Research Analyst at Laidlaw & Company00:24:00I mean, actually, I'm just going to try to get—I'm sorry. Try to get a little bit about the new business model. What new business model can achieve that wasn't really fully appreciated, can be appreciated by the existing ones? Steven LisiChairman and CEO at Beyond Air00:24:21You mean Gen 2 versus Gen 1, Yale? Yale JenSenior Biotech Equity Research Analyst at Laidlaw & Company00:24:24I mean, you mentioned the new business model, which is to purchase our own machine. I just want to get a sense of what does that—what's the benefits of that versus the business operation you have done before this and what additional benefits you can generate from that? Steven LisiChairman and CEO at Beyond Air00:24:47Yeah. Look, the market was set up as essentially a leasing market before we entered the market. We came in, and we worked with hospitals based on what they were used to. We got requests from hospitals, "Can we purchase the machine? Can we purchase the machine?" We were not doing a purchase of the machine in the first two years because we were still making upgrades and tweaking the machine, and it would have been difficult to sell something where you were still upgrading it and improving it. Steven LisiChairman and CEO at Beyond Air00:25:20We are at the point now where there really are not any more improvements to the Gen 1 machine. A little tweak here or there is standard, maybe a software update or something. Those things are not major changes. For hospitals that have been asking us if they could purchase, again, I do not know on their side. They prefer to purchase and to buy the disposables at a much lower rate than the leasing model would have. Steven LisiChairman and CEO at Beyond Air00:25:49Again, that's just their preference. We are offering different models for using our system to the hospitals based on their needs. That's all it is, Yale. We're not abandoning the leasing model in any way. We have multiple different types of leases. We're really just trying to offer the hospitals what they're asking for. The latest one is the capital purchase model. We introduced it a few months ago, and we've got hospitals that are taking advantage of it. Yale JenSenior Biotech Equity Research Analyst at Laidlaw & Company00:26:21Okay. Great. Maybe just follow up on the question. The next question is that you got a lot of international deals signed, which is a great thing to happen because of the massive market over there. I assume most of these are distributors. How should we think about modeling over the long term in terms of what sort of pricing that may generate versus the one in the United States, which is slightly different? How does the filter, renewing filter, fit into that model as well? Thanks. Steven LisiChairman and CEO at Beyond Air00:27:07Yeah. I mean, the ex-U.S. model for us, we're selling things to the distributors, and then they're using it in whatever model they like in their markets, whether it be a leasing model or capital equipment purchase model or something else or some combination of that. That's their business. For us, though, they're purchasing the machines like a capital equipment purchase, and then we're also selling them the disposables, including the filter, which is obviously the most important disposable. That's how you should think about it. In terms of modeling, it's more of just a repetitive revenue line. Steven LisiChairman and CEO at Beyond Air00:27:55I think that that's probably going to happen more in fiscal 2027 than now because we're just getting the systems out there. Once they're placed in hospitals, you see that repeat business, but that's not happening in fiscal 2026. It'll be a fiscal 2027 phenomenon and picking up speed more in fiscal 2028 because we're still waiting regulatory approvals on many countries, and it takes time to get into these hospitals. It is a long process, but that's the way it goes. Yale JenSenior Biotech Equity Research Analyst at Laidlaw & Company00:28:22Okay. Great. That's very helpful. Congrats on the fortified balance sheet, which can do a lot of good things. Congrats. Steven LisiChairman and CEO at Beyond Air00:28:33Thanks, Yale. Operator00:28:34The next question is from Marie Thibault from BTIG. Please go ahead. Sam EiberVP of Medtech Equity Research at BTIG00:28:41Hi, Steve. Hi, Doug. This is Sam Ong for Marie. Thanks for taking the questions here. Maybe I can start on the updated guide, the $8 million-$10 million. Steve, I'd just love your thoughts on the visibility. You have given maybe some of the fluctuations in the hospital sales cycle. Any thoughts on cadence for the back half of the year? Steven LisiChairman and CEO at Beyond Air00:29:05Thanks, Sam. Appreciate it. Look, we've got $3.6 million in the first half, so it's not a large leap to get to the $8 million-plus range, but we have a transition at Chief Commercial Officer. I'm sure everyone on the call would not expect Bob Goodman to hit the ground running in week one or two and start ripping sales straight up. I think it'll take a little bit of time for Bob to implement his processes here and get things moving in the right direction. I think that when there's a change like this, there's going to be a little bit of disruption. That's part of the reason why the $8 million-$10 million is the new guidance. Sam EiberVP of Medtech Equity Research at BTIG00:29:52Okay. Okay. That's helpful. Maybe I can just follow up here on the pace of contract renewals that are coming up. Are you seeing pretty strong renewal rates? Are customers exiting contracts at all? Would just love an update there as well. Thanks. Steven LisiChairman and CEO at Beyond Air00:30:10Yeah. The renewals are going well. We've had a bunch of renewals go from one year. They renewed for three years. We see that happening, not with every contract, but a good number of them. I think that getting on Premier is very helpful. We had a few hospitals that were Premier hospitals that we had contracts with. We were not yet on Premier, so now being on Premier solidifies that. That's very helpful. Steven LisiChairman and CEO at Beyond Air00:30:44We look forward to hopefully getting on HealthTrust as well at some point, and that would give us the big three GPOs. That's very helpful for being able to not only get hospitals but maintain them. Sometimes they can contract outside of their GPO, which is rare, but when we do, when we get on the GPO, it's obviously important. We haven't really seen hospitals leaving us. It's a very sticky business, I think. I think it's due to the team in the field, the machines' performance, and the clinical team here at Beyond Air do an excellent job of supporting the hospitals when they need support. Sam EiberVP of Medtech Equity Research at BTIG00:31:25Really helpful. Thanks for taking the questions, Steve. Steven LisiChairman and CEO at Beyond Air00:31:28Thanks, Sam. Operator00:31:28At 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. Steven LisiChairman and CEO at Beyond Air00:31:41Thanks, operator. Thanks, everyone, for joining. Look forward to speaking to you in the near future. Thank you. Operator00:31:48This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.Read moreParticipantsExecutivesSteven LisiChairman and CEODouglas LarsonCFOAnalystsJustin WalshBiotech Equity Research Analyst at JonesTradingYale JenSenior Biotech Equity Research Analyst at Laidlaw & CompanySam EiberVP of Medtech Equity Research at BTIGGarth RussellManaging Director of Corporate Communications at LifeSci AdvisorsPowered by Earnings DocumentsEarnings 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.comThey're not telling you how bad this could getValuations have reached levels seen only a handful of times in the past century, while debt concerns and tariff-driven supply chain shocks continue to build beneath market headlines. Parkview Capital's new Market Crash Survival Guide breaks down what's happening under the surface and how investors are positioning their retirement savings in response.October 6 at 1:00 AM | Parkview Capital Group (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. Steven Lisi has served as Beyond Air’s chairman and chief executive officer.View Beyond Air ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Latest Articles Lamb Weston’s Turnaround Is Starting to Look RealAI Chip Demand Gives Linde a New Growth CatalystInvenTrust’s Sell-Off Opens a Potential Entry PointCuraleaf’s Higher Aurora Bid Raises the Stakes in Cannabis Consolidation3 Low-Rated Stocks Analysts May Be Underestimating Ahead of Q3 EarningsNVIDIA’s Record High Raises a Bigger Question About How Far the Rally Can RunMarketBeat Week in Review – 09/28 - 10/02 Upcoming Earnings PepsiCo (10/8/2026)Delta Air Lines (10/9/2026)America Movil (10/13/2026)Citigroup (10/13/2026)The Goldman Sachs Group (10/13/2026)JPMorgan Chase & Co. 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PresentationSkip to Participants Operator00:00:00Good afternoon and welcome to the Beyond Air Financial Results Call for the fiscal quarter ended September 30th, 2025. At this time, participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. I would like to turn the call over to Garth Russell, LifeSci Advisors. Please go ahead. Garth RussellManaging Director of Corporate Communications at LifeSci Advisors00:00:20Thank you, Operator. Good afternoon, everyone, and thank you for joining us. Today, after market close, we issued a press release announcing the operational highlights and financial results for Beyond Air's second quarter of fiscal year 2026 ended September 30th, 2025. A copy of this press release can be found on our website, www.beyondair.net, under the News and Events section. Before we begin, I would like to remind everyone that we will be making comments and various remarks about 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. Garth RussellManaging Director of Corporate Communications at LifeSci Advisors00:01:12We 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, www.beyondair.net. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, November 10th, 2025. Beyond Air undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call. Garth RussellManaging Director of Corporate Communications at LifeSci Advisors00:01:58With that, I'll turn the call over to Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. Steve? Steven LisiChairman and CEO at Beyond Air00:02:06Thanks, Garth, and good afternoon to everyone. With me here today is Doug Larson, our Chief Financial Officer. We continue to receive highly encouraging feedback from hospitals using LungFit PH, reinforcing the clinical value and operations efficiency our technology delivers. Adoption has accelerated meaningfully over the past year, contributing to a 128% year-over-year revenue increase in the fiscal second quarter, reaching $1.8 million, up from $0.8 million for the same period last year. While we are pleased by the strong year-over-year growth, sequential growth was essentially flat compared to the prior quarter, reflecting the timing of hospital purchasing cycles and the natural variability in international shipments. We view this stability as an encouraging baseline from which we expect sequential growth to resume over the coming quarters. We continue to navigate the inherent complexity of hospital sales cycles in the U.S. and internationally. Steven LisiChairman and CEO at Beyond Air00:03:01These extended lead times and institutional decision-making processes have led to peaks and valleys in our quarterly sales performance, as seen in the September quarter. Importantly, our sales pipeline remains robust, and we see substantial greenfield opportunities across the U.S. as awareness and interest in LungFit PH continue to build. Before getting into further details, let me highlight the changes that have occurred since our last update in August. We have raised $12 million in debt and will file a registration statement for an additional $20 million through an equity line of credit, both with Streeterville Capital, which solidifies our balance sheet. We believe these additional funds will give us the ability to properly address the pace of sales growth with our first-generation system and prepare for the launch of our second-generation system. LungFit PH has been placed in the first hospital outside the United States for commercial use. Steven LisiChairman and CEO at Beyond Air00:03:55We have named our board member, Bob Goodman, as interim Chief Commercial Officer given the departure of David Webster. We are updating our fiscal year 2026 guidance to $8-$10 million. We introduced our capital purchase sales model in the United States and had our first hospital purchase of LungFit PH. We collected data from Beyond Cancer's phase I-A trial of 10 subjects with ultra-high concentration nitric oxide, or UNO. That shows median survival has not yet been achieved and currently sits at 22 months. These updates have put us in a very strong position and provide us the financial runway we need to optimize the Gen 2 launch in late calendar 2026 and drive our international business from the strong foundation we have already built. As you all know, we were awarded a national group purchasing agreement for therapeutic gases with Premier. Steven LisiChairman and CEO at Beyond Air00:04:52Coupled with our agreement with Vizient, we now have access to nearly 3,000 hospitals. We are confident that our targeted commercial strategy, supported by the right people now in place and strengthened by our Premier and Vizient GPO contracts, will begin to have a meaningful impact on revenue over the coming quarters. Our disciplined approach is allowing us to prioritize the highest-value hospital opportunities while deepening relationships across our existing accounts. This focused execution is already translating into broader market engagement and increased visibility of LungFit PH within key hospital systems. At the same time, we are preparing for the next major inflection point with our second-generation LungFit system, which is smaller, lighter, and designed for both air and ground transportation while maintaining all the revolutionary features of the first-generation LungFit PH. Steven LisiChairman and CEO at Beyond Air00:05:43We believe this next-generation platform will enable us to expand into larger hospitals and health systems, further accelerating adoption and cementing LungFit's position as the standard for nitric oxide delivery. We anticipate commercial launch of the second-generation system in the U.S. market in late calendar year 2026, pending FDA approval. As a significant aside, several of our existing customers have extended their annual contracts with multi-year agreements while increasing anticipated annual volumes. We see this as confirmation of the ease of use and the value proposition of LungFit PH, and we expect this trend to continue. During the quarter, we finalized and have since launched a new sales model that complements the traditional industry leasing model. Under this new approach, hospitals may now purchase LungFit PH systems outright while continuing to generate recurring revenue for Beyond Air through disposables and service agreements. Steven LisiChairman and CEO at Beyond Air00:06:42Initial system sales occurred subsequent to quarter-end, and the early reception has been extremely positive. We are very excited by the flexibility this dual-model approach offers and the opportunity it creates to accelerate adoption of LungFit PH. Today, we announced the appointment of Bob Goodman as interim Chief Commercial Officer following the departure of David Webster. Bob joined the Beyond Air board earlier this year and brings deep commercial and operational expertise from leadership roles at Biotelemetry, Philips Healthcare, Cardiocore, Thermo Fisher Scientific, and Pfizer. His experience spans public companies, private equity-backed businesses, and early-stage ventures, where he has consistently driven innovation, operational scale, and commercial success. We have greatly valued his contributions to the board and look forward to the fresh perspective and leadership he brings as we ramp up commercial activities and, as I just mentioned, prepare for the highly anticipated launch of our second-generation LungFit PH. Steven LisiChairman and CEO at Beyond Air00:07:42A key driver of our long-term growth strategy over the past year has focused on the expansion of our global distribution network. During the September quarter, we added new distribution partnerships in Japan, South Korea, Mexico, Costa Rica, Guatemala, Panama, and El Salvador. These new agreements significantly broaden our geographic reach and demonstrate growing demand from both mature and emerging healthcare markets seeking modern, cylinder-free nitric oxide delivery solutions. Importantly, we achieved our first international commercial placement of LungFit PH into hospitals outside the United States this quarter. These initial system sales mark a key validation of our technology's global applicability and confirm that our value proposition—improved safety, reduced logistical burden, and long-term cost savings—is resonating strongly with hospital administrators and clinicians. We continue to see excellent engagement from our distribution partners, who are now actively seeking regulatory approvals or demonstrating LungFit PH in hospitals in their local markets. Steven LisiChairman and CEO at Beyond Air00:08:42These latest agreements bring our total international coverage to 35 countries, representing a combined population of approximately 2.8 billion people, and we expect to reach our goal of 60 countries under partnership in calendar 2026. As local distributors begin converting opportunities into active installations and sales, we anticipate international revenue contribution to build steadily through fiscal 2026, with momentum accelerating into fiscal 2027. This growing global footprint positions Beyond Air to capitalize on significant untapped demand for LungFit PH and lays the foundation for broader global adoption following additional regional approvals. To wrap up our remarks around LungFit PH, I have two more positive updates to share. Steven LisiChairman and CEO at Beyond Air00:09:27We had a patent allowance for a design patent that covers our second-generation LungFit PH through 2040, and we had data shown by a physician at the Extracorporeal Life Support Organization conference in September, which showed positive results when LungFit was used in the ECMO sweet gas circuit on neonates. I would like to provide an update on the data from Beyond Cancer's phase I-A study. As a reminder, the study enrolled 10 subjects at doses of 25,000 and 50,000 parts per million nitric oxide gas, delivered over five minutes intratumorally. These patients all had metastatic disease and were heavily pretreated. The mean number of total prior surgeries, radiation, and medications was 10.3, with a minimum of 4, maximum of 18. The mean number of all prior medications only was 5.5, with a minimum of 2 and a maximum of 14. Steven LisiChairman and CEO at Beyond Air00:10:23All subjects had a life expectancy of less than 12 months when we treated with UNO therapy. The only adverse event which occurred in one patient that was possibly attributable to nitric oxide was a grade 3 vasovagal response. Otherwise, the safety profile is very clean for this patient population. With respect to overall survival, the median and mean are 22 months and 21.2 months, respectively. These survival numbers will continue to increase, but we have not yet reached the final median survival. Given these impressive data, we are assessing the best path forward for the program at this time. 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. With respect to Neuronas, we recently announced that the U.S. FDA granted orphan drug designation to its investigational therapy, BA-101, for the treatment of glioblastoma. Steven LisiChairman and CEO at Beyond Air00:11:20The Neuronas team is working closely with regulators, investigators, patient groups, and foundations to accelerate development of BA-101 towards a first-in-human study. This program is in addition to the development for BA-102, an investigational therapy for the treatment of Phelan-McDermid Syndrome, or PMS, a syndrome associated with autism. We expect the IND submission for the first-in-human study by the end of calendar 2026. As a reminder, the FDA has also granted orphan drug designation to BA-102 for PMS. Steven LisiChairman and CEO at Beyond Air00:11:54I will wrap up by stating how energized we are following the financing, which will support the continued progress of our global commercial activities and help us prepare for the potential launch of the second-generation LungFit PH. The promise of LungFit is apparent, and we are thankful to the team at Streeterville for taking the time to appreciate our vision to provide clinicians and patients around the world with the optimal NO system. Steven LisiChairman and CEO at Beyond Air00:12:17Now, I will turn it over to our CFO, Doug Larson. Douglas LarsonCFO at Beyond Air00:12:20Thanks, Steve, and good afternoon, everyone. Our financial results for the second quarter of fiscal year 2026, which ended September 30th, 2025, are as follows. Revenue for the fiscal quarter ended September 30th, 2025, increased 128% to $1.8 million, compared with $0.8 million for the fiscal year ended September 30th, 2024. We showed 3% growth versus last quarter. Steve mentioned how our revenue is a little chunkier now, given an international ramp is never straight up. Douglas LarsonCFO at Beyond Air00:12:54We are showing a gross loss of $0.3 million for the fiscal second quarter 2026, compared to a loss of $1.1 million for the same period last year. The improvement was primarily attributed to sales growth. Our margins slipped back negative this quarter due to costs required to upgrade our existing fleet of devices and provisions for excess inventory. Turning to operating expenses, we continue to see cost reduction across the board, in SG&A, R&D, and in our supply chain due to cost reduction initiatives we took in the last 12 months. For the second quarter of fiscal 2026, we reduced total operating expenses to just above $7.4 million from $11.7 million for the same period last year. This translates to a 37% reduction year over year and greater than 56% reduction from a high of $17 million at its peak. Douglas LarsonCFO at Beyond Air00:13:47Going forward, we anticipate R&D expenses will decrease slightly next quarter as the costs related to our Gen 2 device are mostly behind us. SG&A expenses will only move up in line with our commercial performance to maintain our excellence in service and take advantage of coming opportunities. Research and development expenses were $2.5 million for fiscal quarter 2026, compared to $4.6 million for the same period last year. Half of the decrease of $2.1 million was due to a reduction in development costs for our Gen 2 device, while the other half was mostly attributed to a decrease in salaries and stock-based compensation costs. SG&A expenses for the quarters ended September 30, 2025, and September 30, 2024, were $4.9 million and $7.2 million, respectively. Almost all of the decrease of $2.3 million was from a reduction in salaries and stock-based compensation costs. Douglas LarsonCFO at Beyond Air00:14:44Only part of the business that saw an increase in SG&A was in Neuronas, as they start to build a little bit of infrastructure to support the groundbreaking work being done there. Other expense was $0.6 million, compared to a $1.2 million expense for the same period a year ago. The decrease in expense of $0.6 million was primarily attributed to the prior period loss associated with the partial extinguishment of debt. Net loss attributed to common stockholders of Beyond Air was $7.9 million, or a loss of $1.25 per share, basic and diluted. Our net loss for the fiscal quarter ended September 30th, 2024, was $13.4 million, or a loss of $5.67 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. Douglas LarsonCFO at Beyond Air00:15:43Net cash burn for the quarter was $4.7 million, which is a 66% reduction versus a year ago. We 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 September 30th, 2025, we reported cash, cash equivalents, and marketable securities of $10.7 million. As Steve mentioned earlier, subsequent to the end of the second quarter, we announced closing a strategic financial agreement with Streeterville Capital. Under the terms of the agreement, we issued a $12 million promissory note bearing a 15% annual interest rate. This note matures in 24 months from the issue date, with no payments due for the first 12 months. Douglas LarsonCFO at Beyond Air00:16:32In addition, we entered into a $20 million equity line of credit agreement with Streeterville Capital, dependent on our filing an S1 resale registration covering resale of the shares Streeterville Capital may receive under the ELOC. This ELOC provides us with the right, but not the obligation, to sell up to $20 million of newly issued shares of our common stock over a 24-month period, subject to certain limitations. Following these recent financing agreements, we believe that our cash and existing financial vehicles will be sufficient to allow us to support our current operating plans well into calendar 2027 and potentially to profitability, providing we continue to hit our current revenue estimates and continue to control costs at Beyond Air. Douglas LarsonCFO at Beyond Air00:17:15With that, I'll hand the call back to Steve. Steven LisiChairman and CEO at Beyond Air00:17:18Thanks, Doug. Operator will take questions. Operator00:17:24Okay. Thank you. We will now be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we pull for questions. Operator00:17:48The first question is from Justin Walsh from JonesTrading. Please go ahead. Justin WalshBiotech Equity Research Analyst at JonesTrading00:17:55Hi. Thanks for taking the questions. Without going into specific fiscal 2027 guidance, can you comment on the expected growth drivers leading into the potential approval of the second-generation LungFit PH, and then how you're thinking about that trajectory after that second-gen product is out? Steven LisiChairman and CEO at Beyond Air00:18:15Thanks, Justin. Appreciate that. Obviously, the trajectory once the second generation is out should be significantly steeper than what we're seeing now. That's our belief. I think people know the attributes of that system versus the current system and the current competition, so we're confident in that. As for the growth drivers prior to that, I assume you're asking for? Justin WalshBiotech Equity Research Analyst at JonesTrading00:18:44Yes. Steven LisiChairman and CEO at Beyond Air00:18:46Yeah. We're setting up internationally. We're in 35 countries now with partners. We did just place systems in our first commercial hospital outside the U.S. It takes time to build that. We always would go a little faster, but it is being built, and our international team is doing a great job. We've got a lot of seeds planted out there, I guess you could say. Steven LisiChairman and CEO at Beyond Air00:19:10We anticipate that with fiscal 2027 coming up, we should be winning a lot of hospitals outside the United States where the competition is a little bit different than it is in the United States. That is one of the drivers for 2027. The other thing inside the United States, we did introduce a capital purchase model. Our system is now to a point where it is extremely reliable. We have had interest, and we have actually had our first hospital purchase from us. Steven LisiChairman and CEO at Beyond Air00:19:47That would be a capital equipment purchase, and then the filter and the other accessories would be the ongoing purchase. Those prices, I guess it depends on how much nitric oxide you use in your hospital per year per system, but this is certainly very competitive from a per-hour cost basis for nitric oxide. I think this new offering in terms of how hospitals can pay in the United States, we've gotten some interest there, and the XUS will be the driver prior to Gen 2 being approved. Justin WalshBiotech Equity Research Analyst at JonesTrading00:20:21Got it. One more question. You mentioned here that you're hoping to commercialize the second-gen LungFit PH around end of calendar 2026, if I heard correctly. I'm just wondering if you can comment on kind of the thinking around this timing and whether or not you've noticed any delays in your dealings with the FDA recently. Steven LisiChairman and CEO at Beyond Air00:20:41Yeah. I think FDA is doing a great job. I don't think the timing that we're providing is FDA being the limiting factor. It's more supply chain on our side. I think the environment is difficult to get the parts that we need. Sodium doesn't help with all the disagreements, I would say, that are happening around the world with trade. Government shutdown doesn't help either. I think just getting things in place for our ability to get our contract manufacturer in shape for inspection is what we're doing. Steven LisiChairman and CEO at Beyond Air00:21:20It's just a matter of time before that occurs. I did mention, I mean, you did mention we'd be launching before the end of the year. I think approval has to be a little bit earlier than December, obviously, for us to be able to launch by then. We're not going to launch the next day. It's going to take a little bit of time. That's kind of where we are right now. Things can change. Things can be better or worse in terms of timing. As we sit here today, that's the feeling that we have. Justin WalshBiotech Equity Research Analyst at JonesTrading00:21:49Got it. Thanks for taking the questions. Operator00:21:56The next question is from Yale Jen from Laidlaw & Company. Please go ahead. Yale JenSenior Biotech Equity Research Analyst at Laidlaw & Company00:21:59Good afternoon, and thanks for taking the questions. Steve, could you just do some comparison between the new, this model versus the prior ones? Give us a little bit more deep dive in terms of the benefits to the company, maybe for the market penetration. I have a follow-up. Steven LisiChairman and CEO at Beyond Air00:22:22Yeah. Thanks, Yale. I mean, the biggest difference, well, there are a few, but the biggest differences are the size. This second-generation machine will be about 60% the size of the original. It will be what we've applied for. I believe we believe that upon approval, with approval from FDA, it would be approved for use in ground and air transportation. That's critical. I think that's probably the biggest difference maker for us. Steven LisiChairman and CEO at Beyond Air00:22:54The user interface has been upgraded based on feedback from our current customers and some future customers, I guess, who were not using our Gen 1 system but did give us advice on Gen 2. We listened to them, and we built this device based on their input. We think that all of the functions of the device will be a little bit easier and a little bit better for the user. Steven LisiChairman and CEO at Beyond Air00:23:21One other thing that we have is that the maintenance interval will be longer so that the disruption of swapping machines out for those high-volume users will be a thing of the past, let's say. When you have hospitals that are using an exceptional amount of hours per system per year, let's say, way above what the average is, we are bringing them in for maintenance fairly regularly. That's a little bit of a disruption at the hospital, and we're working to get Gen 2 out there, so that disappears. Yale JenSenior Biotech Equity Research Analyst at Laidlaw & Company00:24:00I mean, actually, I'm just going to try to get—I'm sorry. Try to get a little bit about the new business model. What new business model can achieve that wasn't really fully appreciated, can be appreciated by the existing ones? Steven LisiChairman and CEO at Beyond Air00:24:21You mean Gen 2 versus Gen 1, Yale? Yale JenSenior Biotech Equity Research Analyst at Laidlaw & Company00:24:24I mean, you mentioned the new business model, which is to purchase our own machine. I just want to get a sense of what does that—what's the benefits of that versus the business operation you have done before this and what additional benefits you can generate from that? Steven LisiChairman and CEO at Beyond Air00:24:47Yeah. Look, the market was set up as essentially a leasing market before we entered the market. We came in, and we worked with hospitals based on what they were used to. We got requests from hospitals, "Can we purchase the machine? Can we purchase the machine?" We were not doing a purchase of the machine in the first two years because we were still making upgrades and tweaking the machine, and it would have been difficult to sell something where you were still upgrading it and improving it. Steven LisiChairman and CEO at Beyond Air00:25:20We are at the point now where there really are not any more improvements to the Gen 1 machine. A little tweak here or there is standard, maybe a software update or something. Those things are not major changes. For hospitals that have been asking us if they could purchase, again, I do not know on their side. They prefer to purchase and to buy the disposables at a much lower rate than the leasing model would have. Steven LisiChairman and CEO at Beyond Air00:25:49Again, that's just their preference. We are offering different models for using our system to the hospitals based on their needs. That's all it is, Yale. We're not abandoning the leasing model in any way. We have multiple different types of leases. We're really just trying to offer the hospitals what they're asking for. The latest one is the capital purchase model. We introduced it a few months ago, and we've got hospitals that are taking advantage of it. Yale JenSenior Biotech Equity Research Analyst at Laidlaw & Company00:26:21Okay. Great. Maybe just follow up on the question. The next question is that you got a lot of international deals signed, which is a great thing to happen because of the massive market over there. I assume most of these are distributors. How should we think about modeling over the long term in terms of what sort of pricing that may generate versus the one in the United States, which is slightly different? How does the filter, renewing filter, fit into that model as well? Thanks. Steven LisiChairman and CEO at Beyond Air00:27:07Yeah. I mean, the ex-U.S. model for us, we're selling things to the distributors, and then they're using it in whatever model they like in their markets, whether it be a leasing model or capital equipment purchase model or something else or some combination of that. That's their business. For us, though, they're purchasing the machines like a capital equipment purchase, and then we're also selling them the disposables, including the filter, which is obviously the most important disposable. That's how you should think about it. In terms of modeling, it's more of just a repetitive revenue line. Steven LisiChairman and CEO at Beyond Air00:27:55I think that that's probably going to happen more in fiscal 2027 than now because we're just getting the systems out there. Once they're placed in hospitals, you see that repeat business, but that's not happening in fiscal 2026. It'll be a fiscal 2027 phenomenon and picking up speed more in fiscal 2028 because we're still waiting regulatory approvals on many countries, and it takes time to get into these hospitals. It is a long process, but that's the way it goes. Yale JenSenior Biotech Equity Research Analyst at Laidlaw & Company00:28:22Okay. Great. That's very helpful. Congrats on the fortified balance sheet, which can do a lot of good things. Congrats. Steven LisiChairman and CEO at Beyond Air00:28:33Thanks, Yale. Operator00:28:34The next question is from Marie Thibault from BTIG. Please go ahead. Sam EiberVP of Medtech Equity Research at BTIG00:28:41Hi, Steve. Hi, Doug. This is Sam Ong for Marie. Thanks for taking the questions here. Maybe I can start on the updated guide, the $8 million-$10 million. Steve, I'd just love your thoughts on the visibility. You have given maybe some of the fluctuations in the hospital sales cycle. Any thoughts on cadence for the back half of the year? Steven LisiChairman and CEO at Beyond Air00:29:05Thanks, Sam. Appreciate it. Look, we've got $3.6 million in the first half, so it's not a large leap to get to the $8 million-plus range, but we have a transition at Chief Commercial Officer. I'm sure everyone on the call would not expect Bob Goodman to hit the ground running in week one or two and start ripping sales straight up. I think it'll take a little bit of time for Bob to implement his processes here and get things moving in the right direction. I think that when there's a change like this, there's going to be a little bit of disruption. That's part of the reason why the $8 million-$10 million is the new guidance. Sam EiberVP of Medtech Equity Research at BTIG00:29:52Okay. Okay. That's helpful. Maybe I can just follow up here on the pace of contract renewals that are coming up. Are you seeing pretty strong renewal rates? Are customers exiting contracts at all? Would just love an update there as well. Thanks. Steven LisiChairman and CEO at Beyond Air00:30:10Yeah. The renewals are going well. We've had a bunch of renewals go from one year. They renewed for three years. We see that happening, not with every contract, but a good number of them. I think that getting on Premier is very helpful. We had a few hospitals that were Premier hospitals that we had contracts with. We were not yet on Premier, so now being on Premier solidifies that. That's very helpful. Steven LisiChairman and CEO at Beyond Air00:30:44We look forward to hopefully getting on HealthTrust as well at some point, and that would give us the big three GPOs. That's very helpful for being able to not only get hospitals but maintain them. Sometimes they can contract outside of their GPO, which is rare, but when we do, when we get on the GPO, it's obviously important. We haven't really seen hospitals leaving us. It's a very sticky business, I think. I think it's due to the team in the field, the machines' performance, and the clinical team here at Beyond Air do an excellent job of supporting the hospitals when they need support. Sam EiberVP of Medtech Equity Research at BTIG00:31:25Really helpful. Thanks for taking the questions, Steve. Steven LisiChairman and CEO at Beyond Air00:31:28Thanks, Sam. Operator00:31:28At 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. Steven LisiChairman and CEO at Beyond Air00:31:41Thanks, operator. Thanks, everyone, for joining. Look forward to speaking to you in the near future. Thank you. Operator00:31:48This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.Read moreParticipantsExecutivesSteven LisiChairman and CEODouglas LarsonCFOAnalystsJustin WalshBiotech Equity Research Analyst at JonesTradingYale JenSenior Biotech Equity Research Analyst at Laidlaw & CompanySam EiberVP of Medtech Equity Research at BTIGGarth RussellManaging Director of Corporate Communications at LifeSci AdvisorsPowered by