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Beyond Air, Inc. (XAIR)

Q2 2021 Earnings Call· Wed, Nov 11, 2020

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Transcript

Operator

Operator

Greetings, and welcome to Beyond Air, Inc. Second Quarter 2021 Earnings and Corporate Update Call. At this time, all participants are in a listen-only mode. A question-and-answer will follow the formal presentation. [Operator instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Maria Yonkoski, Head of Investor Relations for Beyond Air. Thank you. You may begin.

Maria Yonkoski

Analyst

Thank you, operator, and good afternoon, everyone. Welcome to Beyond Air's second quarter of fiscal year 2021 earnings call. Speaking on today's call are Steve Lisi, our Chairman of Board and Chief Executive Officer; and Douglas Beck, our Chief Financial Officer. This afternoon, we issued -- this morning, we issued in a press announcing the submission of the PMA for LungFit PH to treat persistent pulmonary hypertension of the newborn or PPHN. In addition, after the close, we issued a press release announcing the financial results for the second quarter of fiscal year 2021. A copy of both releases can be found on the Investor Relations page of our website. Before we begin, I would like to remind everyone that comments and various remarks about future expectations, plans and prospects 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. Beyond Air encourages you to review the Company's filings with the Securities and Exchange Commission, including, without limitation, the Company's Form 10-K, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. As a reminder, this conference call is being recorded. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, November 11, 2020. Beyond Air undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call. With that, I would like now to turn over the call to Steve Lisi, our Chief Executive Officer. Steve?

Steve Lisi

Analyst

Thanks, Maria. Good afternoon, everyone, and thank you for joining our call. Before we get started, I wanted to extend a huge thank you and congratulations to every member of the Beyond Air team for the submission of the PMA for LungFit PH to treat persistent pulmonary hypertension of the newborn or PPHN. Despite the difficulties imposed by the ongoing pandemic, our team was able to execute on this critical step, keeping us on track for a U.S. commercial launch in the second calendar quarter of 2021, pending FDA approval. As a reminder, LungFit PH is a lead product from our broader LungFit platform. It is a novel cylinder-free device that is capable of generating nitric oxide, or NO, from ambient air that flows through a reaction chamber where pulses of electrical discharge are created between two electrodes, simulating a lightning strike. The desired concentration of NO is achieved by controlling the voltage and duration of each electrical pulse, giving us the capability to titrate dose on demand or maintain a constant dose for treatment. For PPHN, LungFit PH is designed to deliver a dosage that is consistent with current approved guidelines of 20 parts per million NO, with a range of 0.5 to 80 parts per million. Since nitrogen dioxide or NO2 is a toxic byproduct of NO generation, our proprietary NO2 filters encrypted with RFID chips are required to be securely put in place for the device to generate and safely deliver NO. Our smart filters serve as the razor in our razor blade model. Overall, the LungFit PH is a much smaller and lighter alternative than the traditional fixed supply cylinder-based systems. It is important to note that our system operates with any standard electrical outlet. We believe that the removal of the cylinder makes it a…

Doug Beck

Analyst

Thank you so much, Steve. Here's a brief review of our financial results for the second quarter of fiscal '21, which ended September 30, 2020. Revenue for the quarter ended September 30, 2020, was $350,000 as compared to $646,000 for the three months ended September 30, 2019, all of which was from deferred licensing revenue. Research and development expenses for the quarter ended September 30, 2020, were $3.1 million compared to $2.8 million for the three months ended September 30, 2019. General and administrative expenses for the quarter ended September 30, 2020, were $2.2 million compared to $2.1 million for the three months ended September 30, 2019. For the quarter ended September 30, 2020, the Company had a net loss of $5.1 million or $0.30 per share compared to a net loss of $4.1 million or $0.38 per share for the three months ended September 30, 2019. As of September 30, the Company had cash, cash equivalents and restricted cash of $22.4 million. This cash is sufficient to fund operation will be on in the next 12 months. I'll now hand it back to Steve.

Steve Lisi

Analyst

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

Operator

Operator

Thank you. Ladies and gentlemen, at this time, we will be conducting a question-and-answer session. [Operator Instructions] Our first question comes from the line of Suraj Kalia with Oppenheimer & Company. Please proceed with your question.

Suraj Kalia

Analyst

Good afternoon, Steve. Can you hear me all right?

Steve Lisi

Analyst

Yes. How are you, Suraj.

Suraj Kalia

Analyst

Congrats on your PMA filing.

Steve Lisi

Analyst

Thank you.

Suraj Kalia

Analyst

So I know it's been a long journey, but hopefully, we are coming to the end of it. So Steve, a bunch of questions. The 850 level 3 NICUs treating PPHN. For the audience, can you just walk us through the PPHN volume per center per year? How many feet on the ground would you need? And again, have you all decided on the pricing of filters? And also, what else -- at what point would the FDA need to review -- come and review your manufacturing as we plan for commercial launch?

Steve Lisi

Analyst

Okay. So yes, that's 850 these level 3 and 4 NICUs in the U.S. roughly. There is use off-label in cardiac surgery. So I think you have to add some more hospitals to those who use nitric oxide. So I don't know the total number, but it's probably another 300, 400, 500 hospitals you can add to that number. The market is reported by Mallinckrodt mostly is well over $500 million. So you can kind of just back into kind of volume per hospital. But this is pretty standard, top 20% of customers will roughly be 80% of the market, that classic 80-20 ratio. So I think you can kind of get an idea of what kind of revenues you generated by a certain number of hospitals, if that was - that's your question. I think you asked about when FDA is going to be inspecting us. This is a standard review, 180 days. We would expect FDA to do a pre-approval inspection at some point. My guess is probably somewhere around 90 to 120 days or so from now is pretty standard. So, I really can't speak for the FDA. They'll schedule. They'll let us know. We don't let them know. But that's usually kind of the window that it's in. And we haven't decided on price yet because we're seeing how the market is unfolding. There has been competitors onto the market. So in certain hospitals where there has been some competition, we've seen some rational price decline. So I think that we'll be looking at pricing our -- our pricing structure would be more in line with where you've seen some competition already, not really at the original pricing that now, of course, had in the market as monopoly. So we have to see how things kind of play out. But again, these price declines been very rational, well within the ranges we expected to see when the competition entered. So for us, it's as expected. So we're pretty happy about it. I don't know if I missed anything in there, Suraj. If I didn’t, ask again.

Suraj Kalia

Analyst

Fair enough. I was just trying to squeeze in a number. So Steve, the market you talked about, there's a lot going on, right? And you guys tend to disrupt the market when you'll launch. Walk us through what's going on current? And by that, I mean, one of your -- one of the key players is going through bankruptcy. The other player is lowering prices and trying to go into the cylinder-based approach, and how does that factor in? And just kind of tell us here to the touch point or the stress points you are looking at, this is going to dictate your pricing, and this is what could change the market given the dynamics currently as you view it?

Steve Lisi

Analyst

Yes. So, I really can't speak for what's happening with Mallinckrodt that no idea what their focus is or attention is on this market. We all know what we hear in the marketplace from our initial commercial team. So there's, again, pretty classic competition, nothing out of the ordinary from what we would expect from a new player coming into the market. I don't think it's really impacting how we're going to approach these things. Again, I think you earlier mentioned you asked how many -- what a commercial sales force would look like. Our initial launch will be with a small force targeting small number of hospitals to kind of get our feet wet. And then as we get more comfortable, we'll branch out, but we don't really see the total number of sales for some commercial organization being - it will still be in double digits. We don't think we need to be well below 100 people. I don't think we have to even get close to that at peak. So again, the pressure points, I guess, for dealing with these accounts for hospitals is we need to give them what they need. They need relief from the price, which is already happening to an extent, but I think we can give them more, not just in the price that we offer, but also in the savings at the hospital level. We take up less space. We take up less time, less hassle. It's much easier to track the usage of a filter where they count down and how much is left in a cylinder. These are benefits that we provide to the hospital that save them direct costs rather than just saving them cost by charging them less. So, I think it's a combination of all of…

Suraj Kalia

Analyst

Got it. And Steve, final two questions, I'll hop back in queue. First, does it make sense to still pursue COVID studies, given everything going on with vaccines? So that's one thing. And the second thing, on the solid tumor side, Steve, it's a fascinating approach you and I have talked offline about this, and I appreciate you not wanting to hold off on the details of the delivery device for gNO. I guess my question, Steve, is how do you control the residence time for gNO to achieve a certain clinical response? And is there a limit to the physiologic tumor access with such a device mechanism? Any color there would be greatly appreciated?

Steve Lisi

Analyst

Sure.

Suraj Kalia

Analyst

Thank you for taking my questions and congrats again.

Steve Lisi

Analyst

All right. Thanks, Suraj. I'll start with COVID-19. I can't really speak for vaccines. I know what you know from the minimal information released recently. So we'll have to see what happens. I think we've all been in this industry a long time and I don't think any of us have ever seen anything developed in six to nine months at any level of therapy, so let alone a vaccine, but we'll see what happens. And hopefully, this is actually real and will help patients and will help everything get back to normal. But I still think there's a need for treatments. And if you notice in our study, we're not just treating COVID-19, we are treating acute viral pneumonia, which is the broader condition. So acute viral pneumonia can be caused by a number of viruses, as you all know, whether it'd be RSV or coronaviruses or in such where SARS-CoV-2 is a coronavirus. So we will be enrolling all-comers in this study. Obviously, we want focus, we want to have a good number of SARS-Cov-2 infected patients in our study, so we can get a good sample in case COVID does last a lot longer and the vaccines are not as effective as they're claiming to be. So if they are effective, and of course, COVID dissipates, acute viral pneumonia doesn't go away. This has been around for a long time. I don't think we're going to get rid of acute viral pneumonia. So, we're looking at a broader indication and if we could help and COVID, obviously, we will. We think what's going to work and whether it's SARS-Cov-2 or SARS-CoV-1 or RSV or adenovirus or you name it. We don't care what varies is. We think our therapy is going to be successful. And if we…

Operator

Operator

Next comes from the line of Matt Kaplan with Ladenburg Thalmann. Please proceed with your question.

Matt Kaplan

Analyst

And congrats on the PMA filing.

Steve Lisi

Analyst

Thanks, Matt.

Matt Kaplan

Analyst

Yes. Wanted to zeroing in on your commercial strategy a little bit for the PPHN indication LungFit PH. You mentioned razor blade being your filter. What are your expectations in terms of the device? Will you sell the device, provide it for free, rent the hospital the device, what's your expectation in terms of that part of the program?

Steve Lisi

Analyst

Well, Matt, I don't think we have 100% settled in on exactly what we're going to do. But I think give you some parameters, I'm not sure the vast majority of hospitals are going to want to have a big upfront payment to buy a system. So I don't think that's a good way to go, whether it'd be lease it or rented or so to speak, for an amount of money, a nominal amount of money or what have you. I think that the main focus really needs to be on filters. So I think that's where the bulk of revenues will come from. I think it's the best model for the hospitals. Again, we'll get more information from them. Now that we've submitted, I think they'll be willing to talk more with us about how things are going to look. Obviously, we can't do that much until we get approval. We have to be aware that we can't be marketing our product prior to approval, but I do think that it certainly -- we'll have some inbound calls from people asking us questions and we tour to answer them within all the rules that are out there. For what we can do is a pre-marketed product. But I think, again, the best thing for the hospital is for them to look at the filters and see them as a pay as you go type of instrument. So again, truly think of the razors ratably. We got our razors at home. We paid for it. We got it doesn't really cost much -- most of the time, those razors come in to blade kind of they just throw it in there for an extra $0.50 or something to keep it. And you go by as many blades as you…

Matt Kaplan

Analyst

Right. That's helpful. And then you mentioned kind of a stage rollout. How should we think about that stage rollout into hospitals for the starting in the second quarter of next year? And can you give us maybe some of your thoughts in terms of the number of devices you hope to have in place by the end of the year? Or number of hospitals you hope to have engaged by kind of end of year next year, something like that?

Doug Beck

Analyst

Yes. I mean, in the beginning, I think it's a small number, a dozen, give or take, in the first six months. And I think that's kind of where we want to be. We want to be targeted. We want to work through with hospitals that really want switch that really want to learn and understand that have higher volume a lot of experience. And we need to learn too, Matt. You don't just do these all these studies and then go out there and do 1,000 hospitals and say it's going to be perfect. So we need to go a little bit slow. It's a new device, it's life saving. We need to make sure that the hospitals are comfortable. I don't know if there's any little tweaks that need to be made and how we train or anything like that, need to figure it out early. And then hopefully, by the end of '21, which will be about six, seven months or so on the market, we hope to start expanding. How quickly do we expand? I just don't -- that's the big question. So we certainly will be looking to expand our team towards the end of next year -- our calendar year that is. And we'll see if that doesn't or so hospital goes to 2,000 or 3,000 or more. But we'll know more after the first six months on the market. I think the best thing to do is kind of track us on how we -- how quickly or how many hospitals were able to convert. I think that's probably the best metrics. And your guess -- I mean we have good guesses internally. I'm just going to tell you exactly what I guesses our, but I'm sure you can do some research with the hospitals and figure out how long it's going to take the switch and what we need to do. But again, we're not going out to 100. We're going out two. It doesn't give or take and see how it does and then we'll bring out from there.

Matt Kaplan

Analyst

And in terms of the program for bronchiolitis, you said you're on track to start next year, next fall. What are kind of the rate-liming steps to getting that the bronchiolitis pivotal study off the ground next fall?

Steve Lisi

Analyst

Right, we need to submit to the FDA for an IDE so they can approve our pivotal study. I mean we if you recall at the beginning of this year, we did submit and then the pandemic hit. So kind of put that to the side, obviously. Hopefully, when we talk to FDA over the winter, again, the pandemic doesn't seem to be going away and decisions have to be made early part of next year to be able to start in November of next year. As you know, it's -- you need a good seven, eight, nine months to sites up and running and everything. I mean for COVID studies is raising. Normally, it takes time to get these sites up and running. So we really need cold to press the go button early part of next year. And it's a difficult decision. I don't know if FDA is going to say, well, we're going to approve a study with infants in the hospital with a pandemic coming on, you're out of your mind. I don't know if that's going to be the decision. And it's really going to be up to FDA about how things are progressing with the pandemic. And if it seems like it's more under control and more studies are being done, again, we're talking about 3, 4-month old babies going into the hospital for these studies. Now obviously, if the world is open and these babies are going on hospital anyway, we can do the study. But we do anticipate that this winter is going to be one of the lowest on record for bronchiolitis hospitalizations because of the social distancing. So we're glad we're not running at this winter because we never enroll the patients. So if this is going to be a situation next winter, like we're covering into the winter, where there's a lot of social distancing, we wouldn't be able to understand anything. So it doesn't really matter. But I don't know anybody has a crystal ball can tell me that we're going to be wide open next winter or we're going to be like this next winter. So the first step is to get FDA to agree that we can run the study. And then the second step is to make an educated guess In, I don't know, September or October of next year to see if we're still in a lockdown. If we are, we can't run the study. So we need to have hospitalizations to be able to get babies in the trial. So again, that's kind of where we stand. I wish I had a better answer for you, Matt, but this is on prediction.

Matt Kaplan

Analyst

Just to be clear, it sounds like you'll file -- you plan to file the IDE sometime early next year and then make the go, no-go position in terms of running the study depending on where the pandemic sometime in the early fall that late summer.

Steve Lisi

Analyst

Yes, yes. I mean good things and bad things. We get a COVID vaccine. We can run our bronchitis study. We don't get a COVID vaccine, maybe the COVID-19 treatment is a winner. So we win both ways, I guess. I guess we can't lose, I don't know.

Matt Kaplan

Analyst

And then last question, some very interesting data in the oncology cancer indication with high-dose NO. What are your thoughts in terms of being able to move that into the clinic? What are your were the hurdles you need to overcome to get into the clinic as you hope to late next year?

Steve Lisi

Analyst

Yes. I mean, look, as I said earlier, we need to optimize this delivery system and our regimen. It needs to be optimized. I mean we have had success at -- as you've seen all of our data, we've seen success at 20,000 parts per million to 200,000 parts per million. So we've seen the 50. We've seen different concentrations and for different durations of administration. So we kind of work out what's the best and mice are obviously different than humans in the situation. So we're talking to a lot of experts to try to figure out what's the best way to go with respect to the best safety environment in humans. So there's a couple of different factors that we're working on with our consultants because, obviously, we can go 20,000 up to 200. We can -- we know we have efficacy in that range. It's a very wide range, but there are a lot of other factors that have to be taken into consideration. So we need to do that work and satisfy the regulators so that we've proven that we believe it's safe to go into humans. So again, I don't know what else to say, so that we're optimizing this, and we also need to do it in more animals. I mean, we've done, I don't know, about 80 to 100 animals total. I think we need to get that number up by a couple of multiples. So again, it's not hard to do, Matt. It just takes time as to do it properly. And you can't just rush through this. This is to be done. Systematically, done properly, documented properly. We have to do everything as per the regulatory agencies require. So that's why we're giving ourselves about a year to get the -- to start before we start the study. And I think the team has a good plan, and we'll hit that timeline.

Operator

Operator

Our next question comes from the line of Scott Henry with ROTH Capital. Please proceed with your question.

Scott Henry

Analyst · ROTH Capital. Please proceed with your question.

And congratulations on the filing.

Steve Lisi

Analyst · ROTH Capital. Please proceed with your question.

Thank you, Scott.

Scott Henry

Analyst · ROTH Capital. Please proceed with your question.

Just a couple of questions. Steve, what comes to the product launch, are you preparing to launch it yourself? Or are you committed to a young, would you still consider a partnership? Or is it just too late at this?

Steve Lisi

Analyst · ROTH Capital. Please proceed with your question.

I mean, Scott, I'd say it's pretty late, but there's a price for everything. So I can't say that I'm telling you 100%, there's no way we talk to anybody. But I would say if we don't -- if you don't hear anything from us by, I don't know, by the new year and I think it's impossible to get a partner because there is not enough time to bring somebody in and get this launch right away. I mean, again, there's always a number, but I mean it's a big number right now. So we're fully committed to launching. We've got -- we probably have, I don't know, two-third of the people on board right now that we need to launch with. So have -- obviously, the rest of them will be higher right before the launch, but we're carrying these people right now. And those expenses are already in our P&L for this quarter. So we're ready.

Scott Henry

Analyst · ROTH Capital. Please proceed with your question.

Okay. Okay. That makes sense. And do you need clarification of the situation with Circassia to launch? Or can those two things go in parallel?

Steve Lisi

Analyst · ROTH Capital. Please proceed with your question.

Yes. No, they can. We don't need any clarification there.

Scott Henry

Analyst · ROTH Capital. Please proceed with your question.

Okay. And then I believe you talked about enrolling the pilot study for NTM. I didn't get -- how many patients do you expect to have in that pilot study? And how long would you expect it to take -- to complete enrollment?

Steve Lisi

Analyst · ROTH Capital. Please proceed with your question.

So it's 20 patients. Probably finish enrollment in the second quarter of next year, sometime. It's our best guess. And then it's 12 weeks of treatment and 12 weeks of follow-up. So if we're able to that, I said in the prepared remarks, we've show the final data set towards the end of next year. So if we're able to get the enrollment done by the end of June, 12-week treatment, 12-week patients were good. And it's an open-label study. So it won't take too much time to put data together and get it out.

Scott Henry

Analyst · ROTH Capital. Please proceed with your question.

Okay. Great. And then on the oncology front, I know you put a target out there, first in man, perhaps end of next year. Any catalyst data points that we should focus on over in the interim or I guess, we'll find out as we go?

Steve Lisi

Analyst · ROTH Capital. Please proceed with your question.

For the cancer, you're saying?

Scott Henry

Analyst · ROTH Capital. Please proceed with your question.

Yes.

Steve Lisi

Analyst · ROTH Capital. Please proceed with your question.

Okay. So it depends, Scott. If we get data and we -- and it comes into our hands and we haven't missed a deadline for a conference, then we'll show it. That's probably what we do. I'm not so sure we press release anything at this point that might change. But I think if we have a conference that we'd like to show data at, and we have new and meaningful data, we'll show it. So I think it's going to be real tough given how quick -- how early deadlines are for conferences to see anything in the first half of next year, but maybe in the early part of the second half, there might be some conferences that we can get some data at. But again, that will just depend on the conference and what their dates are for submission to be able to show you data there. But I don't think we're going to be press releasing data as we have in the past. For cancer, I think we've got enough data out there for proof of concept, and we're just focused on getting it to first in man. But again, we do want to show it to the scientific and medical community. So if there's an opportunity, we'll do it. I just don't know if it would make it before we start first to manage just based on those deadlines.

Operator

Operator

Our next question comes from the line of Yale Jen with Laidlaw & Company. Please proceed with your question.

Yale Jen

Analyst · Laidlaw & Company. Please proceed with your question.

Congrats on the progress, Steve.

Steve Lisi

Analyst · Laidlaw & Company. Please proceed with your question.

No problem.

Suraj Kalia

Analyst · Laidlaw & Company. Please proceed with your question.

In terms of the PMA filing, I just want to confirm or understand. If FDA has a time for making decisions to whether to accept the application or not like the drug or they can just accept when they receive it and start to eventually review it?

Steve Lisi

Analyst · Laidlaw & Company. Please proceed with your question.

No. They just -- the device division, just like the drug division has time lines and time points where they say whether they've accepted it for review or not. They do. They have the same kind of structure. So we're not at that point yet.

Yale Jen

Analyst · Laidlaw & Company. Please proceed with your question.

Is that, again, maybe two months, 60 days? Or it's about the next day for that?

Steve Lisi

Analyst · Laidlaw & Company. Please proceed with your question.

It's around there.

Yale Jen

Analyst · Laidlaw & Company. Please proceed with your question.

Right. So would you also I guess, report now that FDA accepted application? Or I guess you just wait until the full 180 days for the decision?

Steve Lisi

Analyst · Laidlaw & Company. Please proceed with your question.

Yes, I'll tell you if they don't accept it, but I mean this is a very, very rare occurrence. And you got to understand the team that we have at Beyond Air, we we've got a team of engineers. I mean, these guys invented the nitric oxide delivery market. They were the rules at FDA. And these are the best guys in the business. Our regulatory team, I mean, they've been doing this for 40 years, ex FDA people. I mean this -- I wouldn't want anybody else to file something in nitric oxide had other than this team. Okay, what company you're talking about. I mean, remember, what -- remember, what the INOmax System as, I mean, they came from another company, which went through like five companies before it became part of million. I mean, these are the guys who built it, built everything. So I'm not really worried about this. I mean that's just a -- I know it's a technical and it's a good question to ask, but when you look at the team we have here, this is not something that really occurs to us as a possibility. I mean it's just not something we're thinking about. It's just the formality.

Yale Jen

Analyst · Laidlaw & Company. Please proceed with your question.

Okay. Great. I mean, I appreciate the confidence, and I think that's very helpful investors as well. In terms of the ATM study, was individual with the CF also to be included in the study or though will be excluded assumptions?

Steve Lisi

Analyst · Laidlaw & Company. Please proceed with your question.

In the NTM study. Yes. So in the NTM study, we can take CF or non-CF bronchiactisis patients. It doesn't matter. We're not forcing either one, it will be up to the physicians. We've given them a leeway, whether their CF patients or no CF patients fine, whether their NTM obsesses or NTM Mac patients is fine. That's really up to the investigators. We obviously have done all CF patients in the past. So we obviously prefer to get some non-CF patients. And we've done only obsessed this in the past. So we prefer to get some Mac patients as well. But again, we're not restricting the.

Yale Jen

Analyst · Laidlaw & Company. Please proceed with your question.

Pretty much all-comer in that regard?

Steve Lisi

Analyst · Laidlaw & Company. Please proceed with your question.

Yes.

Yale Jen

Analyst · Laidlaw & Company. Please proceed with your question.

Maybe two more quick questions. The first one is really rephrasing a question asked a little bit earlier. Which is what do you anticipate the capacity in terms of manufacturing in either the machine or the filter, let's say, in the second half of this year, maybe third quarter, roughly the time of next year and whether the manufacture capability can catch up to it? Or you would need additional production capacity?

Steve Lisi

Analyst · Laidlaw & Company. Please proceed with your question.

So with respect to the filters, our contract manufacturer was worried, we wouldn't order enough filters for them. So, one commercial line can make an enormous amount of filters. So we're good there. We could probably make three years' worth of filter needs and about four, five months. I mean it's just not -- volume on filters is not a problem. Lead time on filters is not a problem. We're just not concerned. We have a great partner. The facility is outstanding. And again, we're looking forward to making them happy, so we can get up to a volume where they can appreciate us. With respect to the LungFit device, look, we have a commercial line Spectronics now. They were before they spun a called Spectronics. They have the line up in their facility. They're excellent. I mean what we have given us so far has been fantastic. It's only getting better every time we make more machines, it gets better and better. The lead time on this is long. That's probably the biggest challenge is lead time and estimating what we're going to need when we need it. Capacity is not the issue. We can -- with that one line, we could probably make enough systems to cover the entire United States in one year. If you said in a year, make it many as you can. I can make enough to cover the entire U.S. for the next five, six years, no problem. So that's really not the issue. No one wants to do that. We don't have the money. It's a waste of everyone's time. So we have to try to figure out how to work with them so that we are able to manage that inventory properly. That's really the biggest challenge. It's not about capacity.…

Yale Jen

Analyst · Laidlaw & Company. Please proceed with your question.

Okay. Great. Maybe the last quick question here or maybe not so quick, which is that now in the cardiosurgical or treatment side revenue presumably is bigger -- is greater than from the NICU in the real world, although that's sort of off-label use. Is there any thoughts how would you be able to penetrate in that market and without violating any law a or other things?

Steve Lisi

Analyst · Laidlaw & Company. Please proceed with your question.

We're not going to do anything different than what others are doing out there. Like, I mean, again, there's no intent to break any laws. There's no -- nothing -- we're just going to market, just like Mallinckrodt and Praxair do going after PPHN. And physicians in the United States have every right to use drugs or products off-label at their discretion. So it will be at their discretion. It won't be us doing any kind of marketing. We will at some point, to expand the label officially. I believe one of the companies in the market has already said recently that they're going to your question that as well. So I hope they do. I hope it becomes on label for the good of patients and reimbursement for hospitals. So everybody will be happy. So again, I don't see that's a competitive disadvantage. No one has it on label. So there's no competitive disadvantage here. We're just going to do what others do and what the chips fall where they will, getting it on label, obviously, be a big help. But I think if one company gets on label, it won't be too long for the others to get on label as well. I don't believe that it would really be a competitive advantage for anybody for any significant length of time. But I do think it's important to get on label. I do think on label would help expand the market, it would give hospitals a little bit more comfort that they can use it a bit more freely in these patients who need it.

Yale Jen

Analyst · Laidlaw & Company. Please proceed with your question.

Okay. Great. And maybe just tap on that one. Have you noticed whether the at this stage, have decided or not decided to do that study you mentioned?

Steve Lisi

Analyst · Laidlaw & Company. Please proceed with your question.

So I only go by what they've announced publicly. And I think they did announce publicly that they would, if I recall, and you can check their public information that they said they'd be submitting at some point. I think they already have, I don't know, for -- I believe it was juvenile cardiac surgery firms not mistaken as the wording, but I think it was in children adolescence. If I'm not mistaken, but I don't know if they have submitted yet or not, I don't know, but they did talk about them submitting it. So we'll see. I don't know what -- I don't know what the timing is to ask them. But again, if they get it or we get it first, I think the other one will just piggyback off the other one. So it's good for patients and good for the expansion of the market. Again, like I said, I don't think it's a huge win for the Company to get it first.

Operator

Operator

That is all the time we have for questions today. I'd like to hand the call back to management for closing remarks.

Steve Lisi

Analyst

I'd just like to thank everyone for attending the call. And look forward to talking to you in the near term. Goodbye.

Operator

Operator

Ladies and gentlemen, this does conclude today's teleconference. Thank you for your participation. You may disconnect your lines at this time, and have a wonderful day.