Beyond Air - Q1 2024

Transcript

Operator (participant)

Good afternoon, and welcome, everyone, to the Beyond Air financial results call for the fiscal quarter ended June 30th, 2023. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. Now I would like to turn the call over to Edward Barger, Head of Investor Relations at Beyond Air. Please go ahead.

Edward Barger (Head of Investor Relations)

Thank you, operator. Good afternoon, everyone, thank you for joining us. Today, after market close, we issued a press release announcing the fiscal first quarter 2024 operational highlights and financial results. 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've been making comments and various remarks about future expectations, plans, and prospects, which constitute forward-looking statements for the 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. This conference call is being recorded and will be available for audio rebroadcast on our website, www.beyondair.net. The content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, August 10, 2023. Beyond Air undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call. Joining me today on the call are Steve Lisi, Chairman and Chief Executive Officer, Duncan Fatkin, Chief Commercial Officer, and Douglas Larson, Chief Financial Officer.

With that, I'll turn the call over to Steve Lisi. Steve?

Steve Lisi (Chairman and CEO)

Thanks, Ed. Good afternoon to everyone joining us today. Since it's only been about 6 weeks from the last time we spoke, we'll keep the prepared remarks short today. LungFit PH continues to be well-received in the market, and we have begun phase two of the commercial launch. We're very happy to report that we have now in excess of $1 million in contracted annual revenue, though only a small portion of these revenues were recognized in the June quarter. We continue to match our momentum in the marketplace with the thoughtful expansion of our commercial team.

Our Chief Commercial Officer will discuss this further in a few minutes. We provided a thorough review of our pipeline during the last call. Everything continues to be on track. Before turning the call over to Duncan, I'll reiterate a few near-term catalysts and highlights.

By the end of the calendar year, we expect to submit a PMA supplement to FDA for the LungFit PH cardiac label expansion, receive CE mark in the EU, and present data from Beyond Cancer's first-in-human trial. Additionally, following agreement with FDA, we will be conducting a pilot study in viral community-acquired pneumonia in the United States this winter. Now I will turn the call over to our Chief Commercial Officer, Duncan Fatkin, for an update on the LungFit PH commercial launch. Duncan?

Duncan Fatkin (Chief Commercial Officer)

Thanks, Steve. Good afternoon to our investors. As Steve mentioned, we have eclipsed the $1 million mark for signed annual contracts. We're very pleased with the momentum our team is building as we progress with phase ll of our launch. The overall feedback from hospitals regarding LungFit PH continues to be extremely positive, and we would again like to thank all the hospitals and clinical staff that have partnered with us and committed to using our device. Our plan is to build out our field team based on the opportunities developed over the past year and the growing interest in LungFit PH as we broaden our reach.

These additions will be carefully targeted and designed to ensure a strong and sustainable foundation for growth. We also expect to add to the team pending the anticipated cardiac label expansion, which we expect to significantly expand our reach in the hospital.

We have planned for a thoughtful and measured increase in the size of our team through to the approval of our next generation LungFit PH, which is anticipated in calendar year 2025. In closing, we are confident that LungFit PH is the best-in-class nitric oxide technology available today, and we continue to be excited by the support we have received from hospitals throughout the U.S. I'm looking forward to providing updates on progress in the upcoming quarters. With that, I will turn the call over to Doug Larson, our Chief Financial Officer, to provide an overview of our financial results for the fiscal quarter ended June 30, 2023. Doug?

Douglas Larson (CFO)

Thanks, Duncan. Good afternoon, everyone. Our financial results for the fiscal quarter ended June 30th, 2023, are as follows: Revenue for the fiscal quarter was $0.1 million, as compared with $0 for the fiscal quarter ended June 30th, 2022. Research and development expenses for the fiscal quarter ended June 30, 2023, were $4.7 million, compared with $3.2 million for the fiscal quarter ended June 30, 2022. The $1.5 million increase was due to an increase in headcount and incremental research, mainly in cancer and autism. SG&A expenses for the fiscal quarter were $10.9 million, compared with $8.2 million for the fiscal quarter ended June 30, 2022.

Almost all of the $2.7 million increase was due to salaries, as additional headcount is needed to scale operations in the field and in the back office. Other income and expense for the fiscal quarter showed a $0.8 million gain, compared with a $0.2 million loss for the fiscal quarter ended June 30, 2022. The gain this year was mainly driven by the remeasurement of warrants and derivatives associated with our long-term debt. For the fiscal quarter ended June 30, 2023, the company recorded a net loss of $15.1 million, of which $14.1 million, or $0.45 per share, was attributable to the shareholders of Beyond Air Inc, compared with a net loss of $10.9 million, or $0.37 a share, for the fiscal quarter ended June 30, 2022.

Net cash used by the company, excluding one-time expenses, was $10.6 million during the fiscal quarter. We forecast our average quarterly cash burn to be approximately $10 million per quarter as we move through fiscal 2024. In June 2023, up to $40 million in debt financing was provided to the company by Avenue Capital, of which $17.5 million in gross funds were drawn in the quarter. As of June 30, 2023, the company had cash, cash equivalents and marketable securities of $57 million. With that, I'll hand the call back to Steve.

Steve Lisi (Chairman and CEO)

Thanks, Doug. We'll now take any questions you may have.

Operator (participant)

If you would like to ask a question, please press star one on your telephone keypad now. You will be placed in the queue in the order received. Please be prepared to ask your question when prompted. Once again, if you'd like to ask a question, please press star one on your phone now. Our first question comes from Les Sulewski from Truist Securities. Please go ahead, Les.

Les Sulewski (VP, Biotech Equity Research)

Good afternoon. Thanks for taking my questions, and congrats on the progress, guys. Just to confirm, the $1 million is now the annual base. Can you quantify the market opportunity out there that's remaining over the remaining of this year? You know, do you have a sense of how many hospitals are out there near end of contracts with the competing products that are marked in your book for an opportunity to convert? I have a follow-up.

Steve Lisi (Chairman and CEO)

Thanks, Les. Appreciate it. Yeah, I guess the $1 million is the base, but that would not be starting at the beginning of this fiscal year. It wouldn't be a start from April 1, it would be a start from this quarter, when we obviously sign the contracts to get us above that level. Just want to be clear on that. Yeah, look, I, I, I don't think that, you know, we're gonna really reveal how many hospitals we're speaking to right now, and what it looks like for the rest of the fiscal year in terms of opportunities for us.

I don't think we want to share that information, but I do think that we will be in a position when we report our next quarter in November to give you some, some guidance on that and probably some guidance for our anticipated revenues for the full year.

Les Sulewski (VP, Biotech Equity Research)

Got it. I understand. Then on the cardiac label expansion, you know, opportunity, what, what size is that in potential to TAM? I mean, does that essentially kind of calculate into your figures that you initially rolled out, or is there more to the story here? Just kind of walk us through the high-level overview of what you think of the cardiac label expansion. Thank you.

Steve Lisi (Chairman and CEO)

Okay. cardiac surgeries, nitric oxide use there, it's, it's the biggest of, of all the, I guess, subcategories for use of nitric oxide in the hospital, would be cardiac surgeries. I think it's very important to get this label expansion. It, it, it will help us have access into an area that's exclusively now off label. That's an area where we don't market and we don't, we don't detail. That's certainly gonna open things up in a good way, I would think.

Les Sulewski (VP, Biotech Equity Research)

Great. Thank you.

Operator (participant)

Our next question comes from Marie Thibault, from BTIG. Please go ahead, Marie.

Marie Thibault (Managing Director and Medical Technology and Digital Health Analyst)

Hi, good afternoon. Thank you for taking the questions. Now that we have revenue, I want to try to understand, you know, how many contracts were signed, how many hospitals now have LungFit PH. You know, any details on contract value and, and, and length of some of these contracts? Just any additional detail you can offer at this time would be really helpful.

Steve Lisi (Chairman and CEO)

Sure, Marie. Probably not too much, most of the contracts are annual contracts. Sometimes they renew for two years, another year or three years, we haven't said. I don't think there's too many contracts beyond 3 years out there, there might be a few. Not for us, perhaps for others. Again, we're not really discussing the number of hospitals we have. There are multiple hospitals. There's plenty for us to get plenty of feedback from our customers that they're very happy with our service and with the product. We're not going to give an exact number. I apologize for that. I'm not really sure how much really more we want to say.

It is a competitive environment, we're, we're kind of keeping things close to the vest, if, if you can understand that. There are other people listening.

Marie Thibault (Managing Director and Medical Technology and Digital Health Analyst)

Of course. Okay, maybe I can ask about growth margins. It's, it's not surprising, of course, that they're negative to start this early in the launch, but how do you think about that flipping positive? What's, what's sort of the right level to think about for growth margins and, and those COGS in the first year of expansion? Thanks for taking the questions.

Douglas Larson (CFO)

So this is Doug. I can, I can jump in with that one. you know, in the next, in the next couple quarters at least, that gross margin is gonna turn, gonna turn positive. The, the drivers behind that are actually the devices that we're producing. We're starting to depreciate them, so there's some costs there, for devices that aren't actually deployed yet. Then, setting up our supply chain infrastructure so that we can expand, across, across the U.S. for wherever we have an opportunity. So those are basically the, the fixed costs, if you will, that are, are gonna be absorbed very quickly as we expand. So again, my expectation is that either next quarter or the following quarter, we'll be in positive territory.

Marie Thibault (Managing Director and Medical Technology and Digital Health Analyst)

Thank you for that.

Operator (participant)

Our next question comes from Scott Henry, from ROTH Capital Partners. Please go ahead, Scott.

Scott Henry (Senior Research Analyst)

Thank you, and good afternoon. A couple questions. First, with regards to selling expenses, what would you estimate the quarterly selling expenses are today, and where would they be at peak? Just trying to get a sense of, you know, how much it costs to market, pay all the reps, how we should think about that number.

Steve Lisi (Chairman and CEO)

Scott, you know, there, there, there is a, there is an industry standard for a fully loaded rep, so I'm sure you know that. You've been modeling this for a long time. You know, we're, we're certainly, you know, on the low end of things. We just started our second phase, where we're starting to bring more people in and hire them. From a pure headcount, we're, we're probably around 15 people or so on the commercial side and growing, and that number is probably gonna get up, you know, well north of 50, probably close to 70-75 people at peak. That peak will probably be, you know, two to three years from now, depending on how quickly we bring people in. It's not gonna be a very rapid expansion.

I would say to use that industry average is a good number, 'cause not all those people that I've mentioned in those numbers will be reps, but when we get out to peak, the vast majority will be reps. Right now, it's a much lower ratio for reps to others because, we really need our clinical specialists, the respiratory therapists, so the ones that are out there training and, and, the, the hospitals that are working with us, right? We need to train. In the beginning, it's very important to have the customer service level very high, and the reps will be expanded later.

Scott Henry (Senior Research Analyst)

Okay, great. That's, that's helpful. Then the $57 million of cash, you know, how much of that is in Beyond Cancer? Just so I get a sense of the net cash you have.

Steve Lisi (Chairman and CEO)

About 30% or so, about a third, maybe.

Scott Henry (Senior Research Analyst)

Okay, thank you. Then when we think about this burn of kinda $10 million a quarter, and, and at the same time you'll be expanding sales, would it be safe to say this is, this is kind of a, the low point? By low point, I mean, this is the, the... where the burn is gonna max out. You probably, as you add sales, you'll also, be bringing in gross profit. I mean, should we think about this being the maximum burn decreasing, you know, maybe not this year, but soon thereafter?

Steve Lisi (Chairman and CEO)

Yes and no, Scott. I mean, it does depend on what we do with our pipeline. If we move into a pivotal study in, you know, in, in calendar 2025, whether that be for pneumonia or, and/or NTM, you know, we're gonna spend. That's gonna cost money, but obviously it would be for a very good reason. You know, we've done four pneumonia studies that have worked. We're entering our fifth pneumonia study in a few months. We would expect the number 5 to look just like the first four in terms of overall efficacy and safety profile. With that kind of confidence going into a pivotal study, we're, we're gonna spend money on it. I mean, we, we don't know how big it will be yet. We're still waiting to get this last study done and speak with the FDA.

I can't say that those costs wouldn't force us to spend more money than $10 million in one quarter. I just don't know. If we're not running pivotal studies, then yeah, you're right.

Scott Henry (Senior Research Analyst)

That leads into kind of a bigger picture question for you and the board from a standpoint of: Is there any concern that you might cast too wide a net? I mean, a lot of these programs are great, you know, it's the working capital problem a new business office faces that, you know, if you stretch yourself too thin, there can be, you know, financial distress. Like, how do you balance that? I know you have a pretty good balance sheet right now, you got a lot of good ideas that you're chasing right now.

Steve Lisi (Chairman and CEO)

Yeah, Scott, we're not chasing them all, that's for sure, for that reason. I mean, we're not, we're not chasing COPD at the moment. NTM's not until 25. We're, we're not stretching. I mean, we're, we're, we're almost two years away from an NTM study starting. COPD is gonna be based on, you know, available funds. We, we, we'd love to do it. We'd love to do it in three months. You know, we, we can't. This launch is the most important thing. The other programs like, you know, cancer is, is, is funded. We haven't entered into the real expensive part of cancer yet. We haven't gone into phase ll human studies, which is where the big money will be spent. That's another 25 occurrence, most likely.

The autism program is, you know, there's not much being spent at the moment on that. It's still obviously in preclinical stage with our partner in Israel. Again, that expense probably won't kick in. Heavy expenses won't kick in till 2026 or 2027 calendar. Can we accelerate these things? Sure. You know, if we have more cash or, or, or, you know, sales come in and we have a good gross profit, then, yeah, we can. Right now we're being very prudent in terms of, you know, which programs we're working on and how quickly we're pushing them. Right now, pneumonia is full steam ahead, and cancer and autism are moving, but the other programs are not moving right now.

Just because you're right, we, we don't have the balance sheet to do everything that we want to do. It's not everything we want to do. I mean, it's everything that the data tells us to do, right? Our NTM data are very strong. Pneumonia, very strong, and with NTM and pneumonia being as strong as they are, it, it begs the question why we're not doing a COPD study. But again, the answer is we're not funded to do that study, so we're, we're just gonna bide our time, make sure that this launch is successful, or more successful. It's already been successful. We'll see how that works out. Yeah, we're being very prudent with our cash. Doug, Doug doesn't like spending money. He's a very good CFO. He, he beats up everybody, so.

Scott Henry (Senior Research Analyst)

Okay, great. Thank you for the color on that. I'll jump back into the queue. Thank you for taking the questions.

Operator (participant)

Our next question comes from Jason Bednar from Piper Sandler. Please go ahead, Jason.

Jason Bednar (Managing Director and Senior Research Analyst)

Hey, good afternoon. Thanks for taking the questions, and congrats on reaching that $1 million milestone. You know, maybe if I could start on some, on the contracting so far and where we're going in the future. I totally understand, Steve, there's only so much you might be able to share, but can you speak to whether the contract sizes are, are what you expect them to be so far? Is there any difference in overall contract size you'd expect as maybe you move further down the road with phase ll of your commercial plans? Just anything you can share there.

Steve Lisi (Chairman and CEO)

I, I think that they're fairly in line with what we thought, in terms of overall size. There, you know, there, there's a mix, right? The, the, the, the volume at hospitals is, is a huge range in, in the US. You know, you have hospitals doing, you know, 1,000 hours, 500 hours, 2,000 hours. Your hospital is doing 50,000+ hours of nitric oxide a year, so it, it varies all over the place. I, I think, it's, it's in line with what we had expected. And I, and I would say the same thing about the pricing, pretty much what we expected as well. Right now, we're not really seeing anything that, that's outside of the parameters that we had entering into the market.

Jason Bednar (Managing Director and Senior Research Analyst)

All right, that's great to hear. Then, I'd be curious just maybe on the competitive response from some of your closest peers. Just thinking, again, given where you're at and where you maybe hope to be in a year or two, I think, you know, having some perspective today would be, would be enlightening. Just how are you seeing them behave as they start to lose contracts to you? Are they getting more aggressive in follow-up contracting efforts? Are they holding the line on where they're pricing? Again, just curious how the success you're starting to have in contracting is influencing their behavior at all.

Steve Lisi (Chairman and CEO)

They've been aggressive from day one. I don't think it's changed. I think they're nervous. They're worried. That's how they're acting, it's how they're behaving. I might do the same thing if I were in their shoes, you know? I, I don't think that there's anything that they're doing that, that, again, is, is surprising to us. You know, I, I, I would expect some of the things they're doing to be done. I might not do everything they're doing, but certainly some of the things they're doing, if I were in their shoes, I would do. It's a competitive environment. There's no doubt about it. You would expect all the players to do everything they can to either keep customers or, or, or, or, or take customers from, from, you know, a competitor.

I mean, Duncan, you're on the line if you have anything else to add to that. You're a little closer than I am.

Duncan Fatkin (Chief Commercial Officer)

Sure. Appreciate the question. I think that there's a couple of things I would say. Firstly, a lot of the competitor activity was apparent to us before we even started to get contracts. A lot of the work that was done was to block us from even getting in there in the first place. I think that what we've done is we've broken through in various locations, and actually, once people get exposure and do evaluations, et cetera, then, then things start to build. The, the way that these things work is they then start to see that another hospital in their area is using the device, and they get more confident, and so the neighboring hospitals start to get involved. The other thing that happens is that the initial contracting is easier with individual hospitals.

There's not that many of those nowadays, so the larger groups and small networks take a little bit longer, and we're starting to get to those now, and we're, we're getting to that phase where a lot of those contracts are running out, which wasn't the case at the beginning of our launch, so it's a much better environment for us. In other words, our competitors have thrown a lot of their sort of ammunition at us already to stop us from getting in. The response, once we're in, isn't that different, so we're feeling much more positive about where we are as we get through that process.

Jason Bednar (Managing Director and Senior Research Analyst)

All right. Perfect. Thank, thank you. Maybe one just quick clarifying question to finish it off. I, I think it seems like there's no change on the CE mark timing or expected timing on receiving that. I think that, you know, originally or last quarter, you had said, you know, September, October timeframe. Does that still hold? I know you're saying by the end of the calendar year, but should we still expect it here within the next couple of months?

Steve Lisi (Chairman and CEO)

Yeah, I, I would love to announce it on our next quarter. That would be my goal, but you know, this is, this is out of our control. We, we are, you know, moving as quickly as we can, but again, you know, this is, this is a regulatory matter, and sometimes, you know, it just, just takes a little longer than you expect. I, I hope to announce it on our next quarter. That, that's my goal. We'll be like, you know, second week in November, roughly. I expect to announce it there. If not, you know, I'll let you know where I stand then. Yeah, the guidance, we, we just give our guidance based on...

You know, Ed here told me, "Steve, you know, we got to be consistent with guidance this half, that half, instead of saying a month." I'm gonna go with Ed, and we'll say by the end of the year, but I hope to say it in November.

Jason Bednar (Managing Director and Senior Research Analyst)

All right. Very helpful. Appreciate it. Thanks, guys.

Operator (participant)

Our next question comes from Matt Kaplan from Ladenburg Thalmann. Please go ahead, Matt.

Matt Kaplan (Managing Director)

Hey, guys. Thanks a lot for taking the questions. I guess now that you're kind of in, in the phase of signing contracts. Maybe, what would be helpful, can you tell us a little bit about the mechanics of signing a contract? Is there a demo period, a test drive period, and then potential conversion to contract, or how does that work?

Steve Lisi (Chairman and CEO)

Yeah, in the beginning, Matt, it, it was, you know, always a demo, and, and, and then there's, there's an evaluation. I think that the evaluation is, is not as important for every hospital anymore now that we're out there, and there's experience, and people chat to each other, and, you know, it's a small world, the RT world. There's lots of little conferences. They're all, you know, meeting each other and talking about what's going on. I, I, I think that going forward, we may not need to do an evaluation at every potential customer, and eventually, we won't be doing evaluations at all. I would say that probably, you know, sometime in, in, in calendar 24, we, we won't be doing evaluations any, any longer. It'll just be what we call bench testing, and then we go into a contract.

We're, we're kind of, you know, over that initial phase, where everybody was evaluating, to the point where some are still evaluating and some aren't. Eventually, we're gonna get to the point where there's just no more evaluations because there's so much experience with our product and so much comfort and confidence in us as a company being able to support the hospitals, that there won't be no more need for that evaluation.

Matt Kaplan (Managing Director)

Okay. I guess now that you're in the second phase of the, the launch, what do you see as the kind of bottleneck in signing new contracts?

Steve Lisi (Chairman and CEO)

Wow! I'm gonna let Duncan go on that one, but I, I would say I don't think there's one, one specific bottleneck. There's not one thing that, that stops you from getting a contract. I, I think it's, you know, hospital-specific. They all have different things that are important to them, and sometimes, you know, it, it, it hits our sweet spot, and other times it doesn't. I, I don't, I don't think it's so simple to say that every hospital has the same opinion or viewpoint or needs. I, I don't think there's one bottleneck. I know, Duncan, you might wanna follow up there.

Duncan Fatkin (Chief Commercial Officer)

Sure. No, it's a good question, Matt. I think that contracting during the first 12 months was definitely the, the area we had to spend most time navigating because a lot of hospitals and are part of those systems, as I described just now. The way they do that and the bureaucracy associated with that definitely was initially our biggest sort of challenge. I do think of it like dominoes. Once you start knocking over some of those hurdles, then a lot of the others become freer. Then there are individual hospital situations, changing from one hospital, one device to another involves an investment in training, et cetera.

Depending on where they are in their particular supply chain process, they might have other priorities within the hospital that mean that they're not willing to focus on our particular category at the time, which is kind of related to contracting, but also related to the hospital's individual priorities. From a clinical point of view, we're, we're not getting pushback clinically. It's really more on the contracting side, where we have to navigate that. That, that's really where most of our work is evolving and improving.

Matt Kaplan (Managing Director)

Okay, wonderful. That's helpful. If the average number of devices per hospital and the expectation for the average revenue per device, how should we think about that?

Steve Lisi (Chairman and CEO)

I'm not going to tell you how to think about that, Matt, because then everybody else would know. You know, the, it's pretty wide, you know, in terms of how many hours per year per system a hospital uses. It's a pretty big range. Different hospitals have different needs, like I've said. It's a very difficult question to answer. I don't want any of our, of our competitors to know how we think about that and how we view it, because it's very important in, in how we approach things. I wish I could give you those answers, but, but I can't. I mean, I can-

Matt Kaplan (Managing Director)

Yeah, yeah.

Steve Lisi (Chairman and CEO)

I won't.

Matt Kaplan (Managing Director)

Yeah, fair enough. Fair enough. Just, just a last question, and as you're getting close to the CE mark, what's your partnering strategy ex-U.S., or, or do you plan to, to, to go it alone outside of the U.S.?

Steve Lisi (Chairman and CEO)

We are not going it alone outside the U.S., that's for sure. We... It's enough to build up a commercial team in the U.S. That, that's all we can handle for the moment. We will partner ex-U.S., and our goal is to get the best royalty rate we can on net sales, and, and that's what we'll do. Hopefully, you know, we'll, we'll, we'll be able to talk, talk more about that in the near future.

Matt Kaplan (Managing Director)

Great. Great. Congrats on the progress, Steve. Thank you.

Steve Lisi (Chairman and CEO)

Thanks, Matt.

Operator (participant)

Our next question comes from Yale Jen from Laidlaw & Company. Please go ahead, Yale.

Yale Jen (Managing Director, Biotechnology Analyst)

Good afternoon, and thanks for taking the questions, and congrats on your first commercial sales. My first question is, in terms of the $59,000 revenue of this quarter, what's the sort of accounting principle behind it, and how is that being recognized, and how should we think about going forward, in terms of, does the same sort of principle apply?

Douglas Larson (CFO)

Sure. This, this is Doug. Thanks for the question, Yale. The best way to think about it is for, for the most part, we're signing annual contracts. Most of the contracts from a revenue recognition perspective, I mean, it's a little more complicated than I'm going to make it, but if you think about it ratably over the life of the contract, that's pretty safe. I mean, we do have to do some testing every quarter to see if we're within the range of use of the machines and things like that. For the most part, annual contract, ratably over, over the 12 months is how we're going to, how we're going to recognize that revenue.

Yale Jen (Managing Director, Biotechnology Analyst)

Okay, great. That's, that's very helpful. The question, just follow up on, on the previous one, which is regarding the getting label on the cardiovascular side. Question is that, it, INOmax has been used in real world off-label, presumably get, also get reimbursed for a long time. What could be the additional benefit if you guys get a label for your system?

Steve Lisi (Chairman and CEO)

Well, yeah, I mean, the, the, the main benefits obviously are, are our ability to directly market, to, to cardiac surgeons, as well as, you know, potential for reimbursement. There's no doubt, but you know, Yale, it takes time to get a specific code, so, we wouldn't have a direct code day one. There might be miscellaneous codes of, of some sort, but a direct code would take several years, as you know.

Yale Jen (Managing Director, Biotechnology Analyst)

Right.

Steve Lisi (Chairman and CEO)

Was there any, was there anything else you were looking for besides those? Those are the two main benefits.

Yale Jen (Managing Director, Biotechnology Analyst)

Okay, does that, just, just to confirm that, currently, the use in the cardiovascular surgery, this will also get a reimbursed or not necessarily get reimbursed?

Steve Lisi (Chairman and CEO)

No, it is off-label use. There's... You know, I can't speak for what the hospitals do, but it is 100% off label, so I think that reimbursement is difficult.

Yale Jen (Managing Director, Biotechnology Analyst)

Okay, great. Maybe the last question here is in terms of your VCAP trials that you intend to start this winter. Could you give us a little bit more color regarding the study design and making the endpoint and others, as well as how this one should be considered as a phase ll, maybe phase lll? How do we sort of categorize that? Thanks.

Steve Lisi (Chairman and CEO)

Yeah. I, I would look at the design of our study that we, we, we had in Israel for pneumonia. It's going to be very similar to that study. This will not be a registration study. We're a device, Yale, not a drug, so it's not phase l, ll, lll. It's pilot pivotal, so this will be another pilot study. FDA has requested that. After this study, the next one would be a pivotal or a registration study. This study, then one more, and we would hope to get approval from that.

Yale Jen (Managing Director, Biotechnology Analyst)

Maybe just to refresh our memory, that in terms of the endpoint, well, what's the endpoint they're pursuing, and any other color on the study?

Steve Lisi (Chairman and CEO)

Yeah. Obviously, it'll be safety is the primary if it's not a pivotal study. That's easy. On the efficacy endpoints, in the study in Israel, it was an oxygen-specific endpoint. It was a time to oxygen cessation for these patients in and out of the hospital. You could look for an endpoint similar to that, something along the lines of, you know, either how long they're on oxygen or whatever time period we pick, how many hours they didn't need oxygen. Something along those lines will be related to oxygen. Again, when we did the infants in pneumonia, there were no comorbidities, so it was easy to look at, you know, hospital discharge or being fit for hospital discharge.

Those endpoints are not relevant with adult pneumonia, as they have multiple comorbidities, and there could be several other reasons besides the viral infection that caused their hospitalization for them to stay beyond the resolution of the pneumonia episode. We need to measure something else, and there will be some other endpoints besides the oxygen-related, but I think that is the one that we'll be looking at closely.

Yale Jen (Managing Director, Biotechnology Analyst)

Maybe a squeezing one more, which is that, does that endpoint could be considered as approvable endpoint from FDA's perspective, or have you guys spoke with the agency in terms of this issue?

Steve Lisi (Chairman and CEO)

This, this won't be a registration study, so I, I, I can't say that the endpoints we have in this study as secondaries would be considered the, the endpoint to be used in a registration study. You, you, you could guess that, you know, my team and I are not, are not, you know, looking at this for no reason. We're, we're looking at this because this is what we believe would, would be something similar to what would be in the pivotal study. I, there's no way for me to guarantee that there's an endpoint in my current study that would be mimicked for my pivotal. Hopefully, it's close to it, but we would still have to sit with FDA to agree upon what the exact primary endpoint would be in that study.

We, we haven't agreed to that yet, and that, that's pretty standard. I, I think what we have as our secondary endpoints on the efficacy side is going to give us the answers we need to get an agreement with FDA on a primary endpoint. I, I'm pretty confident that we're gonna have something that will work.

Yale Jen (Managing Director, Biotechnology Analyst)

Okay, great. That's very helpful. Again, congrats on the first sale.

Steve Lisi (Chairman and CEO)

Thanks so much, yeah.

Operator (participant)

At this time, there are no further questions. I'd like to turn the call back over to Steve to close out the call.

Steve Lisi (Chairman and CEO)

Thanks, everybody. Appreciate your time. Look forward to talking to you in three months.

Operator (participant)

This concludes today's conference call. Thank you for attending.

The host has ended this call. Goodbye.