Beyond Air - Earnings Call - Q4 2025

Executive Summary

• Q4 FY2025 revenue grew 145% year over year to $1.15M but missed S&P Global consensus of $1.39M; GAAP EPS was ($0.09) versus consensus of ($2.44). Management introduced FY2026 revenue guidance of $12–$16M and guided “at least” $1.7M for Q1 FY2026, while clarifying Gen2 (PH II) is not included in the outlook. Revenue consensus and EPS consensus from S&P Global; values marked with * are from S&P Global.*
• Commercial ramp continues: >45 U.S. hospitals installed and using LungFit PH; 3 new hospital starts and 3 renewals in Q4. International distribution now covers >25 countries (>2B lives) and “more than a dozen” LungFit PH units shipped OUS in recent weeks; expect OUS contribution to accelerate in 2H FY2026.
• Product/regulatory: PMA supplement for transport-ready LungFit PH II was submitted (smaller, lighter, transport-ready); management expects PH II, once approved, to be a major share and volume driver, but timing remains uncertain and is not embedded in guidance.
• Cost/cash: Operating expenses down ~58% over six quarters; FY2025 cash/cash equivalents and marketable securities were $6.9M (excludes $1.0M GETZ payment post-3/31 and $2.0M additional debt draw). Management cites runway “well into calendar 2026” assuming revenue ramp and cost control.

What Went Well and What Went Wrong

• What Went Well
  • Strong top-line trajectory: Q4 revenue rose to $1.15M (+7% QoQ; +145% YoY), with management signaling “at least” $1.7M next quarter and FY2026 $12–$16M, reflecting U.S. hospital adoption and early OUS momentum.
  • Strategic OUS expansion: >25 country distribution coverage (>2B lives); “more than a dozen” units shipped OUS recently; OUS contribution expected to be meaningful from 2H FY2026.
  • PH II catalyst submitted: PMA supplement for LungFit PH II (transport-ready) filed; management: “we are confident that the introduction of LungFit PH II will play a pivotal role in accelerating our market expansion”.
• What Went Wrong
  • Revenue miss: Q4 revenue of $1.15M missed S&P Global consensus of $1.39M*. FY2025 revenue of $3.71M also came in below $3.92M*. Revenue consensus from S&P Global.*
  • Profitability/margins: Gross margin remained negative despite improvement (gross loss of $32k on $1.15M revenue); net loss was ($8.04M) for Q4, reflecting depreciation and one-time upgrade costs and a high fixed-cost base.
  • Balance sheet tight: FY2025-end liquidity was $6.9M in cash and securities (pre $1.0M GETZ and $2.0M additional debt after quarter-end), underscoring reliance on execution and financing arrangements to reach management’s targeted runway.

Transcript

Speaker 2

Good afternoon and welcome everyone to the Beyond Air Financial Results Call for the fiscal quarter and year ended March 31, 2025. At this time, participants are in a listen-only mode. The question-and-answer session will follow the formal presentation. I would like to turn the call over to Corey Davis with LifeSci Advisors. Please go ahead.

Speaker 0

Thank you, Operator. Good afternoon, everyone, and thank you for joining us. Today, after the market closed, we issued a press release announcing the operational highlights and financial results for Beyond Air's fourth quarter of fiscal year 2025 ended March 31, 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'd like to remind everyone that we will be making comments and various remarks about future expectations, plans, and prospects which constitute forward-looking statements for purposes of the Safe Harbor Provisions under the Private Securities Litigation Reform Act of 1995. Beyond Air cautions that these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated.

We encourage everyone to review the company's filings with the SEC, including without limitation, the company's most recent Form 10-K and Form 10-Q, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. Additionally, this conference call is being recorded and will be available for audio rebroadcast on our website, beyondair.net. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, June 17th, 2025. 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, Chairman and Chief Executive Officer of Beyond Air. Go ahead, Steve.

Speaker 2

Thanks, Corey, and good afternoon to everyone. With me here today is Doug Larson, our Chief Financial Officer. We are quite pleased with the progress we've made over the past year. For the fiscal year ended March 31, 2025, we reported a 220% increase in revenue to $3.7 million, compared with $1.2 million for the same period last year. All of this growth came from U.S. sales, with the majority coming from hospitals signed during the back half of the year. As a result, we have tremendous revenue growth built in to kick off fiscal year 2026, along with several new growth drivers, as I will discuss in a moment.

With this in mind, we have decided to also announce that we are on track to report revenue of at least $1.7 million for the quarter ending in just two weeks on June 30, 2025, which translates to greater than 45% sequential quarterly growth and greater than 145% year-over-year growth. In addition, we are providing revenue guidance of $12-$16 million for the full fiscal year ending March 31, 2026. This level of projected growth moving forward shows how we are overcoming the barriers to entry in the nitric oxide market and are well on our way to making LungFit PH the market leader. The more customers use LungFit PH, the more confidence grows in the product and our ability to provide top-tier service. This is an exciting time for our team and our shareholders.

Let me now dig a little deeper into the numbers for the fiscal fourth quarter of 2025 and growth drivers for fiscal 2026. The commercial team's efforts have led to a steady flow of new hospital contracts throughout fiscal year 2025. During the fourth quarter, we saw three new hospital starts and three hospitals renew their contracts. As I've mentioned recently, we have established a solid customer base across key target regions in the U.S. We are pleased and thankful that many of these customers have made themselves available as references for LungFit PH over recent months, which has proven to be a valuable tool when establishing new accounts. Further to the customer reference approach, we have partnered with Vanderbilt University Medical Center, naming them as the first luminary site for LungFit PH.

Through this program, we will work alongside the Vanderbilt team to further optimize LungFit products and explore new opportunities to enhance hospital-based nitric oxide therapy. In addition, Vanderbilt has made themselves available to better showcase the full utility of LungFit PH technology to respiratory therapists, anesthesiologists, nurses, and other relevant clinicians at hospitals considering adopting our cylinder-free nitric oxide delivery system. This collaboration marks a major milestone in our core mission to redefine tankless nitric oxide delivery and drive continued innovation in respiratory care. Now, I would like to update you on the status of LungFit PH2, our next-generation system. As announced yesterday, we have submitted a PMA supplement to FDA. LungFit PH2 is smaller, lighter, and designed for air and ground transportation, while still delivering all the revolutionary features of the current FDA-approved system.

Additional improvements include a more intuitive user interface, more functional backup system, adjustable alarm volume, and significantly less frequent maintenance. All of these improvements were made with extensive input from our customers. We anticipate that the anticipated FDA approval of the second-generation system and subsequent introduction to the U.S. market will have a major impact on our market share, total NO volume, and logistics within the hospital. Looking outside the U.S., over the course of just the past six months, we have quickly ramped up our commercial program across Europe, Southeast Asia, and the Middle East. These activities have included securing key regulatory approvals, including CE Mark, as well as signing distribution agreements across more than two dozen countries covering over 2 billion lives.

Today, we announced that the team has recently signed several new international distribution partnerships for the following countries: India, Italy, Latvia, Lithuania, Estonia, Ukraine, Kuwait, Kazakhstan, Israel, and Poland. As a reminder, because the LungFit system generates NO from room air, unlike other systems that require NO-filled cylinders, we are opening an enormous new opportunity in geographical areas around the world where hospitals are unable to obtain nitric oxide supply or do not use nitric oxide due to the logistical difficulties associated with cumbersome cylinder-based systems. I am pleased to report that we have already shipped more than a dozen units of LungFit PH to customers outside the U.S. over the course of just the past few weeks. As a result, we plan to see a meaningful contribution from these activities reflected in our financial results starting in the back half of fiscal 2026 and beyond.

Turning to Beyond Cancer, as previously reported, they received regulatory approval in Israel to begin a phase 1b trial for Low-volume Uno, or ultra-high concentration nitric oxide, in combination with anti-PD-1 therapy in late-stage cancer patients who have failed anti-PD-1 therapy. This remains an area of high unmet patient need. Timing for the initiation of this study is under review. On to Neuronas, our subsidiary focused on therapies for autism spectrum disorders. We were pleased to announce recently that the U.S. FDA granted orphan drug designation to our lead investigational therapy, BA-102, which is being developed for the treatment of Phelan-McDermid syndrome, a syndrome associated with autism spectrum disorder. As many of you are aware, this designation provides key development incentives, including seven years of market exclusivity upon approval, tax credits for qualified clinical trials, waiver of FDA application fees, and access to FDA protocol assistance.

Neuronas will meet with FDA later this year to get an idea of the path to human studies, which we expect to begin late in calendar 2026. The excitement around our autism program goes beyond our walls. This is evident by our ability to recruit leaders in the field to our scientific advisory board. Just recently, we announced the appointment of Nobel Prize laureate Professor Dan Shechtman to the Neuronas SAB. We believe bringing in Professor Shechtman to join Professor Roger Kornberg from Stanford University on this board brings unparalleled scientific expertise to the Neuronas team. During the March quarter, Neuronas published a peer-reviewed journal article in Translational Psychiatry, which presented breakthrough research by its Chief Scientific Officer, Professor Haitham Amal, which shows compelling evidence of a novel mechanism in the early stages of Alzheimer's disease.

These new preclinical data further underscore the consistency and power of Neuronas' platform and offer new hope for the development of effective therapies for this devastating condition. Building on the excitement around the data and progress of its programs, Neuronas announced at the end of March that it completed a $2 million equity financing from private investors as part of a larger funding round. This investment will accelerate the preclinical development of Neuronas' small molecule drug designed as an injectable or oral treatment for children with autism. Turning to the corporate side, we're excited to announce today the appointment of Bob Goodman to our board of directors, effective June 13, 2025. Bob is a seasoned healthcare executive and board director who brings decades of commercial leadership experience from across the medical technology, pharmaceutical services, and medical device industries.

His career has included executive roles at Biotelemetry, Philips Healthcare, CardioCore, Thermo Fisher, and Pfizer. Our board and management team look forward to working with Bob as we continue to build positive momentum across the commercial side of our business. Before I conclude my comments today, I want to mention that our LungFit Go program is still moving along. We are dedicated to bringing this therapy to market to improve the lives of patients suffering with lung infections. We plan to meet with FDA prior to year-end to discuss the clinical path forward. We continue to make significant progress in executing against the strategies for each of our businesses. Past years showed just a glimpse of how LungFit PH will transform the global NO landscape for the better and gives us a solid foundation from which to continue to build.

Beyond Air team will continue to be diligent on its path to profitability and improving the lives of patients in need of the benefits of nitric oxide. Now, I will turn it over to our CFO, Doug Larson.

Speaker 3

Thanks, Steve, and good afternoon, everyone. Our financial results for the fourth quarter of fiscal year 2025, which ended March 31, 2025, are as follows. Revenue for the fiscal year ended March 31, 2025, increased 220% to $3.7 million, compared with $1.2 million for the fiscal year ended March 31, 2024. We're showing a $1.7 million loss in gross profit for the fiscal year 2025, compared to $1.3 million for fiscal year 2024. Cost of revenue of $5.4 million were recognized in the fiscal year, compared with $2.5 million in the fiscal year ended March 31, 2024. Cost of revenue exceeded revenue primarily driven by the depreciation of LungFit devices and one-time upgrade costs to systems. Research and development expenses were $16.9 million for fiscal year 2025, compared with $24.4 million for the fiscal year ended March 31, 2024.

The decrease of $7.5 million was primarily attributed to a decrease in salaries, stock-based compensation, and to a lesser extent from clinical and preclinical study expenses. SG&A expenses for the year ended March 31, 2025, and March 31, 2024, were $26 million and $37.3 million, respectively. The decrease of $11.3 million was attributed primarily to a reduction in salaries and stock-based compensation cost. Other expense was $3.9 million, compared to $1.3 million a year ago. The increase in other expense of $2.6 million was mainly due to a non-cash loss recorded upon the retirement of Avenue Capital debt. Net loss attributed to common stockholders of Beyond Air was $46.6 million, or a loss of $0.69 per share, basic and diluted. Our net loss for the fiscal year ended March 31, 2024, was $60.2 million, or a loss of $1.82 per share, basic and diluted.

Net cash burn for the year was $44.1 million, which is more than 28% lower than previous year. We've talked in previous quarters how we've been laser-focused on fixed cost reduction in R&D and in our supply chain. Now that we're wrapping up spend on development of our next-generation LungFit device, we'll see further reduction in our cash burn in Q1 and again in Q2. I would like to take a moment and expand a bit on our cost reduction efforts. Over the past six quarters, we've reduced operating expenses from north of $17 million to just above $7 million in the current quarter. This translates to a 58% reduction. We believe the trough in our operating expenses will either be in the coming June quarter or the September quarter. Please do not interpret that expenses will be moving up significantly in the December quarter.

Expenses will move up in proportion to our commercial performance to maintain our excellence in service and take advantage of coming opportunities. As of March 31, 2025, the company had cash, cash equivalents, and marketable securities of $6.9 million. Please note this does not include the $1 million payment we received from Getz Healthcare, nor the additional $2 million investment into our existing synthetic royalty debt structure, both of which we received after March 31, 2025. We believe our cash, cash equivalents, marketable securities, and existing financing vehicles will be sufficient to allow us to support our current operating plans well into calendar 2026 and potentially to profitability, provided we continue to hit our internal revenue estimates and control costs at Beyond Air. I'll hand the call back to Steve.

Speaker 2

Thanks, Doug. We'll now take some questions. Operator.

Speaker 4

Thank you. We'll now be conducting a question-and-answer session. If you'd like to ask a question, please press Star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press Star 2 if you'd like to remove your question from the queue. Participants using speaker equipment may need to pick up your handset before pressing the Star keys. One moment, please, while we poll for questions. Thank you. Our first question is from Marie Thibaut with BTIG.

Hi, good afternoon, and congrats on the progress here. I wanted to ask my first question here about LungFit PH2. Great to see that get in. I wanted to understand if that system approval is being assumed in the fiscal year 2026 guidance range that you've given us, and how we should think about the selling dynamics ahead of that potential approval. Is that something where hospitals see that coming approval and say, "Hey, I want to get exposure to LungFit before that comes out"? Is it they wait a little bit as they're waiting for that next-gen system? Help us think about some of those dynamics.

Speaker 2

Thanks, Marie. Fiscal 2026 guidance does not include the second-generation system at all. To answer your other question, we do not promote the Gen 2, obviously, until we get approval. People know it exists, obviously, and they do inquire, but I think the focus is on Gen 1. That is what we are promoting now, and that is what we are marketing and pushing. Yeah, I mean, obviously, there are some hospitals that are interested in getting exposure to Gen 1 immediately, and then there are others who will choose to wait. We have seen both at this point.

Okay. Very encouraging. Very helpful, Steve. I wanted to ask also about OUS. You've gotten several shipments out there, it sounds like, of units. What are we understanding about what some of those contracts look like? Is there any difference in how hospitals use this versus how they use it within U.S. hospitals? Any trends or specific countries we should be looking toward, or any other catalyst OUS? Just want to get a little closer to that market.

Yeah, I think it's a little early for us to see any trends in actual hospitals outside the U.S. Right now, our shipments are initial shipments to distributors, and they're taking those and using them for demonstration to get interest to have hospital placements. There's much more of a tender process outside the United States than in the U.S., so it takes a little bit longer to get into the hospitals. I think the back half of this fiscal year, we'll see a big upswing on the international side as we get hospital placements, and we'll get some trends at that point. Our initial work in the market outside the U.S. is showing consistency in terms of how they use nitric oxide. You know, outside the U.S., cardiac surgery is on label, so they're definitely using it in that area.

Again, it's similar to how it's used in the United States.

Okay. Very helpful updates. Thanks a lot, Steve.

Thanks, Marie.

Speaker 4

Thank you. Our next question is from Jason Woods with Roth Capital.

Hi, thanks for the questions, and congrats on the progress here. On the PMA submission, do you have an expected timeline for when we may see an approval for that for LungFit PH2?

Speaker 2

Jason, did you ask me when FDA is going to approve it?

I just do you have an estimate is what I'm asking. I guess I'd add to that, how should we think about a potential launch? I think you had indicated earlier that it's kind of staged launch versus an immediate bolus type hit. I'm just curious about the dynamics around what we might expect when the FDA approves this device.

Okay. So yeah, I'm going to stay away from the exact timing on an FDA approval. I mean, everybody kind of knows what's going on at FDA right now. There's a little bit of an upheaval. Let's just kind of let things settle in. It'll take a few months for us to interact with FDA and get a better understanding of their questions on our application. Perhaps I can give some more timelines or better guidance on timing at that moment in time. As for the launch for Gen 2, obviously, we're going to prep for that as we work with FDA. There's always a period where you need to build up inventory and you need to scale up your manufacturing. It will take a couple of months, and then we will try to keep up with demand.

That'll probably be the challenge that we have post-approval.

Okay. That's a totally appropriate answer. I get it. I appreciate the guidance, which looks quite strong. We're at the low end. There's a big range there. I mean, what has to happen to get to the higher end of that range for the $12 million-$16 million that you're kind of pointing to for 2026?

Yeah, it's not really that big of a range. I mean, $4 million range, I guess it seems that way because it's a small 12-16. It's not 100-104.

Percentage-wise, certainly, but dollar-wise, certainly.

Right. But you know, I mean, you can get a couple of contracts that are a good size, and it can move you a few million dollars. We can get some regulatory approvals overseas for some big countries and get some big orders in. To us, it's not that big of a range because things can swing dramatically with some of the things that we have going on in the pipeline. That's kind of how we view it. We look at it as we feel pretty comfortable getting to the low end of that. There are a couple of things in the works that could get us into the mid and upper range of that. If anything changes, we'll update you. I mean, I know the next call we have is in early August, so there might not be any kind of change at that point.

Certainly, by November, we'll have a good idea of how we're looking for getting into the range or perhaps maybe we get lucky. Maybe it'll be at the high end or higher. We just don't know at this point. There are too many moving parts, and it's only June. It is exciting for us.

Got it. That's helpful. Maybe just another clarification on, did I hear correctly? Basically, on the expense line, there will be further reductions expected through September, and then you basically grow with revenues on the expense line. Is that the right way to think about modeling the P&L?

Yes. Exactly.

Okay. That's all I got. Thanks. And congrats on the PMA submission.

Thanks, Jason.

Speaker 4

Our next question is from Justin Walsh with JonesTrading.

Hi. Thanks for taking the question. Now that you guys are supplying globally, I was wondering, I guess, the degree to which you're seeing impacts or worried about impacts from some of the emerging geopolitical questions. I mean, we have a moving target with U.S. tariffs, and you mentioned that you're supplying to Ukraine, and of course, you have ties in Israel. Just curious how all of that is impacting things or not.

Speaker 2

I don't think it's impacting us that much. I mean, we manufacture in the U.S. for the LungFit, so the vast majority of our costs are in the U.S. We do source some parts from outside the U.S., but it's not a major impact if those tariffs and some of the big ones are going to stay in place. It's a low single-digit % impact on our cost of goods. It's not a major impact on us. On the reverse side, we haven't really seen anything about where we're shipping to in terms of tariffs on the other end at this point. As for Israel and Ukraine, I mean, honestly, it wasn't a—Israel's great to be in. It's not a large country, but it will impact our ex-U.S. sales.

We're very happy to be there, but I don't think it's a major driver like a France or a Turkey or an Australia, India. These are much bigger countries where we are. To be honest, we were very surprised and happy that the distributor that we're working with in Eastern Europe had Ukraine on their list. We're very excited to be able to help the distributor there go into Ukraine, but that we didn't have any expectations for. That's just a subside.

Great. Maybe just to follow up on that, I'm curious if you're seeing more uptake in some of those geographies or where you think some of the markets might be a little bigger. I mean, obviously, you just mentioned a couple of them, but wondering if you're, I don't know, really think you'll take off in India or somewhere in particular.

Yeah, I mean, it depends. They're all different in terms of regulatory timing. India, we have a partner, but there's a regulatory process to go through. The impact from India on this fiscal year will be minimal. Some of the other countries like Australia, Thailand, France, Romania, Turkey, these places, the regulatory process is already done or a very short time, so we'll get some more impact from them. Like I said earlier on an earlier question, it's a little too early because there are tender processes in a lot of these countries, so it takes time to get into some hospitals. We're going to wait the next three, four, five months to see how those go and how many we get and how quickly we get in.

Every country is different, so this is new for us as a company and new for this product. Even our international team who has experience with this, this is a new product. I mean, no one's ever seen a non-cylinder-based nitric oxide system outside the United States before, and certainly not one that makes it from ambient air. This is kind of new for everybody. We have some distributors who are extremely excited, jumped at the opportunity, and it was a very quick process to sign them up. Others are a little kind of more skeptical, I think, because they can't believe what the machine does. I think we're just in the early stages, and it's exciting.

I'll probably have a better idea maybe on the next call or the call after that of where we're going to move quickly and which country is going to move fastest. Right now, it's just kind of feeling it out, and we're excited to have this many partners and this many countries open to us at this moment in time.

Great. Thanks for taking the questions.

Thanks, Justin.

Speaker 4

Our next question is from Yale Jen with Wade Law & Company.

Good afternoon, and thanks for taking the questions and congrats on the guidance as well as the performance. We just got about three here. The first one is that you suggested you will have more than $1.7 million for the next quarter or current ongoing quarter, actually, and $12 million-$16 million for the fiscal 2026. What is the confidence you can provide that are behind these forecasts or projections? I have a follow-up.

Speaker 2

Thanks, Yale. I mean, we're pretty confident. We wouldn't have put it out if we weren't. I think the fact that the June quarter ends in two weeks, we're pretty confident it'll be $1.7 million. There could be something that happens in the next two weeks to bump it up a bit. We can't really predict that, but we're highly confident in that number. As for the fiscal year, we're pretty confident. I mean, we've got a lot in the hopper here, especially on the international side. Even in the U.S., there's movement in some areas that we're excited to see and maybe happening a little bit sooner than we thought. I'll give you an example. We're very flexible with the customers and how they want to structure their contracts. It's very easy with our system to be as flexible as they would like us to be.

One of the things we started offering earlier this year is the razor razor blade model. The purchase of our system and then the ongoing purchase of the consumables, which is mainly the filter. We have gotten some good feedback over the last month or two on that model. We may actually see some hospitals jumping at the opportunity for that rather than the more traditional nitric oxide model, which is how many hours you use, X amount, this is what your annual cost could be divided by 12, and you get paid that per month. That is really the main way it is done, but we are offering this other way of doing it with the purchase model. We may see some of that in this fiscal year, and that is exciting.

That gives us some confidence in our numbers because it was not something we were seeing six to nine months ago at all.

Okay, great. That's very helpful and confident. Also, in the press release, you mentioned you have about 45 hospitals in the United States now either installed or actually as well as using the LungFit systems. Going toward, let's say, end of this year, fiscal years, or maybe calendar years of this end of this year, do you anticipate what might be the estimate or projection of the number of hospitals you may have as well as maybe whether you will also see the volume increase per hospital?

I definitely see the volume increasing per hospital. We've been seeing that for the past year and a half. A lot of our hospitals are going over what their estimate was for the year. That's a good thing. We do offer a discounted hourly rate if they go over. Certainty of price is important for the customer. I think that may continue. Hopefully, hospitals can work with us and get a better handle on what they're going to use for the year, so there's certainty in what they're spending. I don't want to speculate on the total number of hospitals we're going to have at the end of the fiscal year. While it's important, not every hospital is created equal. Some hospitals are small in terms of their volume, and some are very large in terms of their volume.

We could have one hospital be worth 10 in some cases. Obviously, 45 is a great number. I certainly see it being significantly more than that number at the end of the fiscal year. I am not going to take a guess and try to triangulate that exact number right now, Yale. Thank you.

Okay, great. Maybe just squeezing one more question, actually, is follow up the earlier one. For the PMA applications, I know this is difficult to predict the time for a possible approval. Just let's assume, or maybe if in the "normal" circumstances, would this process maybe take about 12-16 months or shorter? Just curious, what would be the sort of reference point we can at least think about? Thanks.

Yeah. There are statistics that FDA puts out about PMAs. This is a PMA supplement. FDA puts statistics out about how long these things take, so you can see them online. I just caution you to take these averages because not every PMA is created equal. We are just a supplement. We basically make nitric oxide the same way with our second-generation system as our first-generation system. A lot of the things that we do are equivalent. It is obviously smaller. It obviously has some enhanced features, and it obviously is built to be used for transport and ambulances and helicopters and airplanes. There are some differences, but from how it operates, it is really not that much different. Could we be quicker than the average that FDA puts out? Probably.

If you look at FDA's guidelines, it's 180 days for a PMA supplement, and they normally do not hit that 180 days. It's not that they can't hit their timelines. A lot of times they have questions, and that clock will stop while you're having discussions with FDA. That's something that companies don't control. FDA does, and we're going to work with them to get this done as quickly as possible. I just don't know what that timeline will be at this point. We'll have a better handle once we start discussions with FDA in the next couple of months.

Great. That is a lot of great colors on the story. Again, congrats and thanks for taking the question.

Thanks, Yale.

Speaker 4

Our next question is from Jason Bednar with Piper Sandler.

Hey, guys. Thanks for taking the question. This is Joe Downing on for Jason. Congrats on the PMA submission. Just wondering if there's any difference you can call out in the sales process with the 2.0 device versus the 1.0 device. And then just off of that, can you just remind us how much this LungFit 2.0 expands the market?

Speaker 2

Joe, thanks for the questions. I mean, we're not trying to sell this Gen 2 or market the Gen 2 right now, so we're not going to comment on how the process is different because we don't have a process yet. We have to wait for approval on that. As for how it opens the market, I mean, it vastly expands this market. It opens it up for us as a company to every hospital in the world that wants to use nitric oxide. We can get it anywhere. Our Gen 1 is already in remote locations treating patients, so the Gen 2, it'll be even easier to do that. This is something that will change the way people use nitric oxide in the hospital. I think that it will increase volumes overall and, again, reach hospitals that don't use nitric right now.

This is, for us, I think, and for the industry, it's a game changer. It really is.

Great. Thanks, Steve. Appreciate that. Just one last one on the competitive landscape. Your largest peer put out a new offering a number of months ago. Just wondering if you're seeing anything worth calling out with contract negotiations with hospitals as a result of that launch.

Which one are you talking about?

Mallinckrodt.

Oh, the Mallinckrodt offering? Yeah. We haven't seen a change. I mean, the contracts are usually one, three, and five years in this market. We haven't really seen any change in that. At least my team and I haven't really seen much change. Yes, they're out there with their new offering, and they're marketing it for sure. I think last time they spoke, they gave an idea of how many hospitals they were in or something or that they were in hospitals. You can take a look at what their transcript said. Yeah, it's just another competitor. It's another cylinder-based system out there. That's the fourth cylinder-based system in the United States.

Great. Thanks, Steve. Appreciate it.

Yep. Thanks, Joe.

Speaker 4

At this time, we are showing no further questions in queue. This does conclude our question-and-answer session. I would now like to turn the call back over to Steve Lisi for any closing remarks.

Speaker 2

Just like to thank everybody for joining us today, and we'll talk to you in August. Thank you.

Speaker 4

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