Beyond Air - Q4 2023

Transcript

Operator (participant)

Good afternoon, and welcome everyone to the Beyond Air financial results call for the fiscal year ended March 31, 2023. At this time, participants are on 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, and thank you for joining us. Today, after market close, we issued a press release announcing the fiscal fourth quarter and full year 2023 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 will be 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, June 22nd, 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 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, and good afternoon to everyone joining us. Welcome to phase two of our commercial launch. This is an exciting time for us as we have visibility into what the PPHN market will look like over the next several years. With our initial limited launch completed, we are highly confident that we have gained the knowledge required to satisfy the needs of hospitals using nitric oxide. LungFit PH has been well-received in the market, and we believe that our ability to support and service most hospitals has been established. Now is the time to increase the size of our commercial team and increase our market share. Our Chief Commercial Officer, Duncan Fatkin, will have more on this in a few minutes. Outside of LungFit PH commercial operations, we have been very busy, and I am proud of what the Beyond Air and Beyond Cancer teams have accomplished.

LungFit PH cardiac label expansion application will be submitted before the end of this calendar year to FDA. This is later than we had hoped, but we want to be certain that the application is high quality and will satisfy FDA requirements. We also expect CE mark in the EU for LungFit PH late next quarter. We anticipate LungFit PRO will be used in a community-acquired viral pneumonia study in the United States this coming winter. LungFit GO is scheduled for an at-home COPD study start in 2024 and NTM in 2025. Beyond Cancer anticipates Phase Ia data this fall. As announced last week, we now have another NO-related program, autism. Please refer to our announcement last week for details.

Our portfolio consists of programs where NO is approved to treat acute pulmonary hypertension in newborns, is in human studies for hypoxemia associated with viral lung infection, chronic refractory persistent lung infection, and solid tumors, and in preclinical development for autism. We can consider ourselves the preeminent NO company with the investments we have made into NO research and development. We believe that we have only scratched the surface of the impact NO plays in human health. We recently secured debt financing of up to $40 million from funds managed by Avenue Capital Group. We believe this additional capital strengthens our position to execute on our strategy for LungFit PH and our other programs. In addition, I believe that securing this capital from a well-known healthcare investment firm with a history of investing in nitric oxide speaks volumes about our programs and the progress we're making.

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 just mentioned, we've made steady progress with our commercial launch over the past few quarters. The feedback from hospitals regarding LungFit PH continues to be extremely positive, and we would like to thank all the hospitals and clinical staff that have contributed to this first wave of clinical use. As I mentioned on previous calls, our go-to-market strategy is a multi-phased commercial approach. The initial phase represented a measured release of LungFit PH to a select group of hospitals who use inhaled nitric oxide on a regular basis. During this first phase, we received positive feedback from a variety of different hospitals on our logistics, customer service, and the clinical performance of the device. As a result, several hospitals have signed contracts for LungFit PH.

These accounts set an important foundation from which the team will build upon. In regard to our sales pipeline, we're excited by the interest in LungFit PH. As one point of reference, we have conducted more than 150 in-person demonstrations that have resulted in positive feedback and helped to optimize the LungFit PH system, our service and support, supply chain, logistics, and back-office operations. Based on our success to date, we moved into the second phase of our commercial program in the beginning of the current quarter. In this phase, we are expanding our commercial team, both field sales and clinical specialists, and expanding our network of reference hospitals and key opinion leaders. We expect that this will lead to market share gains over the next 10-12 quarters before we enter the final phase of commercialization.

In closing, we continue to be excited by the growing coalition of hospitals supporting this amazing new technology and believe the program has gathered tremendous momentum to drive future growth. We project the annual value of contract signings over the next six months to be measured in the $ millions. In addition, a key point to remember is that the customer base and commercial function that we're establishing will support the future launch of LungFit PRO for additional indications for the hospital, if and when approved. With that, I will turn the call back to Steve for the pipeline review. Steve?

Steve Lisi (Chairman and CEO)

Thanks, Duncan. I will start with LungFit PH. I mentioned earlier that CE mark is expected near the end of the next quarter, and we expect the FDA submission for the cardiac label expansion before year-end. We continue to execute on our regulatory strategy and our interactions with the FDA and other regulatory authorities, prioritizing as needed. We are confident that both milestones will be achieved. With respect to our VCAP program, we are preparing to conduct a study this coming winter in the United States. This study will not be a pivotal study, but a small study that we would expect to lead to a pivotal study. As for LungFit GO, we look to initiate a pivotal study in the first half of 2025, pending discussion with the FDA for NTM.

We hope to initiate a pilot study in the second half of 2024 for COPD patients released from the hospital after having been hospitalized for an exacerbation. This is an exciting time for the clinical, regulatory, and engineering teams. Before I move on to Beyond Cancer, I would just like to emphasize that to date, we have completed multiple studies in several clinical settings where 150 parts per million to 250 parts per million nitric oxide has been delivered to the lungs in more than 145 patients and over 4,500 individual administrations, with 0 serious adverse events directly attributable to nitric oxide. In addition, strong efficacy trends were seen in multiple studies.

This portfolio of clinical data, along with our preclinical data, leads us to believe that exogenous nitric oxide, generated and delivered by LungFit, will improve the lives of patients. Earlier in the current quarter, we presented impressive new in vivo and in vitro data at the American Association for Cancer Research annual meeting. These data suggest that ultra-high concentration NO, or UNO, is effective in treating solid tumors as a single agent and in combination with checkpoint inhibitors such as anti-PD-1 and anti-CTLA-4. To be more specific, the data shown in mice were in a very aggressive triple-negative breast cancer model called 4T1, and UNO therapy, in combination with both anti-PD-1 and anti-CTLA-4, showed improvements in survival against each checkpoint inhibitor alone. Repeated UNO therapy suggests that repeat dosing is safe and effective.

We remain very enthusiastic about our ongoing Phase Ia human clinical study, which is expected to have top-line data later this calendar year. I would like to emphasize that thus far, the data from the human study are consistent with the preclinical animal studies with respect to immune biomarkers. Turning to our newest program, neuronal nitric oxide synthase, or nNOS inhibitors, I would like to thank Dr. Haitham Amal and his team at the Hebrew University of Jerusalem for working with us over the past year. We expect big things going forward. The relationship is focused on what nNOS inhibition can do in neurological disorders and, as stated in our recent announcement, is initially focusing on reversing the effects of autism spectrum disorder.

Considering we just held a conference call dedicated to the announcement of this particular program last week, I suggest anyone who didn't listen to the live call, visit our website and listen to the archive of the call. I will now turn the call over to Doug Larson, our chief financial officer, to provide an overview of our financial results for the fiscal year ended March 31st, 2023.

Douglas Larson (CFO)

Thanks, Steve, and good afternoon, everyone. Our financial results for the fiscal year ended March 31, 2023, are as follows: Revenue for the fiscal year ended March 31, 2023, was 0, as compared with 0 for the fiscal year ended March 31, 2022. I'm very happy to say that this will be the last time that you hear me say that revenues are 0. On a GAAP basis, research and development expenses for the fiscal year ended March 31, 2023, were $16.8 million, compared with $11.8 million for the fiscal year ended March 31, 2022. The main driver of the $5 million increase was compensation costs from scaling up operations in Beyond Cancer. We also further increased staff in Beyond Air's R&D team, recognized some of the initial work with autism...

Had generated costs early in the fiscal year for the final push to get approval for the LungFit for PPHN. Selling, general, and administrative expenses for the fiscal year ended March 31st, 2023, increased to $34.7 million from $18.4 million for the fiscal year ended March 31st, 2022, mainly due to $9.2 million in structural investments in Beyond Cancer, with the remaining $7.1 million mainly driven by the US commercial launch. Other operating expenses for the fiscal year ended March 31st, 2023, were 0, compared with $10.5 million, which were entirely related to the contingent liability for the Circassia settlement from May of 2021. As a reminder, we paid $2.5 million to Circassia in the second fiscal quarter of 2023.

We have another $3.5 million to pay in the second fiscal quarter of 2024, with the final $4.5 million not due until the second quarter of fiscal 2025. Other income and expense for the fiscal year ended March 31, 2023, was a net loss of $7.3 million, compared with $3.4 million for the fiscal year ended March 31, 2022. The $3.9 million increase is from a non-product-related legal matter that was previously partially reserved for and resolved in the fiscal fourth quarter.

For the fiscal year ended March 31st, 2023, the company had a GAAP net loss of $59.4 million, of which $55.8 million, or $1.86 per share, was attributable to the shareholders of Beyond Air, Inc., compared with a net loss of $43.2 million, or $1.68 per share, for the fiscal year ended March 31st, 2022. Net cash used by the company, including Beyond Cancer, was $37.9 million during the fiscal year ended March 31st, 2023. We forecast our average quarterly cash burn to be approximately $10 million per quarter as we head into fiscal 2024. As of March 31st, 2023, the company had cash and cash equivalents of $45.9 million.

We believe that this amount, in addition to the $17.5 million secured through our agreement with Avenue Capital, is sufficient to fund operations for at least the next 12 months. With that, I'll hand the call back to Steve.

Steve Lisi (Chairman and CEO)

Thanks, Doug. Hope everyone is as pleased as I am with the execution and progress at Beyond Air. Operator, let's go to Q&A.

Operator (participant)

Thank you. Ladies and gentlemen, at this time, we'll be conducting a question-and-answer session. If you'd like to ask a question, you may 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 would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. Our first question comes from the line of Marie Thibault with BTIG. Please proceed with your question.

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

Hi, thank you for taking the questions this evening. Very glad to hear that we will be seeing revenue this next, coming quarter. Would love to hear a little bit about how the fiscal fourth quarter went, the timing of some of these contracts that you described as signing, and what you can tell us about, you know, what's taken place commercially in the last couple of months here, as you've shifted to Phase 2.

Steve Lisi (Chairman and CEO)

Thanks, Marie. Appreciate that. I'm going to turn this over to Duncan, our Chief Commercial Officer, to comment on that.

Duncan Fatkin (Chief Commercial Officer)

Thanks, Marie, for the question. The contracts, typically, there's quite a few that start in the first quarter of a first month of a quarter. You get that kind of effect. We fought to get some of these to start a little bit earlier, but the timing of the negotiations and the way that kind of fell just pushed us a little bit further, but certainly nothing that's put us off our long-term schedule. From a learnings point of view, we continue to get really good clinical feedback. The training's going really well, and we've refined the way we train and go to the hospitals, and we've certainly made some improvements to the software to make the system work even better than it has been.

It's certainly fair to say that we're a little bit behind where we wanted to be. Some of the supply chain challenges from earlier in the fiscal year kind of flowed through. We've taken our time to work with our team, and they've done an amazing job, actually, to make sure we can stay close to where we need to be. Going forward, we're focusing on expanding. As you can see from the prepared remarks, we're going to increase the team now because we feel like we're ready to support that expansion, something that we were a little bit more cautious about earlier on in the year.

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

Okay, that's really helpful, Duncan. Maybe I can ask as a follow-up, how should we think about that commercial sales force expansion? What do you think is the right number for this phase, and, you know, how quickly are those folks getting hired? As a second part of that question for Doug, maybe, if I look at the SG&A this quarter and exclude the $9 million or so that was invested in Beyond Cancer, I'm getting to about $25 million. Is that the right level that you would have us look at for SG&A here in this next fiscal year?

Steve Lisi (Chairman and CEO)

Hey, Marie. Steve, I'll take the sales force expansion. It's, you know, it's an expansion to what we would believe it would be our peak size, and I think we've said that number would be somewhere in 70-80 total people. That wouldn't just be sales reps, that would be everybody, you know, clinical specialists and operations and marketing and so forth. That'll probably take us, you know, the next 18-24 months to bring those people on in an orderly manner, get them on, train them, deploy them, and go back and bring more people on. That's how it will happen. We're not in any rush to bring the people on, you know, in one big fell swoop, like maybe a much larger company might do.

this is a, you know, a good 18-24-month exercise that we've begun to go from, you know, a sub-20 number and multiply that by 4-5x. Does that answer your question, Marie?

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

That does. That does. I wonder if Doug could comment on the, you know, the $25 million in spend this quarter and what it might look like going forward.

Douglas Larson (CFO)

25 million is the annual number if you pull out cancer. That was, the $9 million is an increase versus last year, so it's not-

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

Yep.

Douglas Larson (CFO)

-the absolute number, that we're looking at, right? We did have 3 months of cancer last year. We've got 12 this year. Keep in mind that we are going to continue to consolidate, cancer into our numbers as well. I don't know if you're trying to pull those numbers apart.

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

Mm-hmm.

Douglas Larson (CFO)

it might be a little bit tricky. We could maybe follow up on that one, if that.

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

Okay.

Douglas Larson (CFO)

if that works.

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

Okay. Okay, certainly. Happy to follow up later. Thanks for taking the questions.

Steve Lisi (Chairman and CEO)

Thanks, Marie.

Operator (participant)

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

Matt Kaplan (Managing Director and Head of Healthcare Research)

Hi, thanks for taking the questions. Just staying with the LungFit PH, I guess now that you've completed phase one of the launch, can you tell us a little bit more about what you accomplished in phase one? Specifically, maybe some more detail around the number of contracts and then with that, what we should look for as you now launch into the second phase of the commercial program here.

Steve Lisi (Chairman and CEO)

Matt, I'm going to let Duncan talk about what we've learned and what's going to help us going forward. With respect to the number of contracts, I mean, we did state that we had multiple contracts that have been signed. I would say that the number as we see here today is less than 10, so we're looking at single-digit number of contracts. You know, going forward, obviously, we expect that number to increase, you know, quite dramatically over the next 4-6 quarters. I mean, as we bring more people on and we, you know, are able to handle more volume of customers, it's going to increase significantly. That's always the plan with our three-stage, step process towards this launch.

As we've had in our slides for the past 18 months, we've been stating on every quarterly conference call that phase 1 would be where we, you know, learn and make sure everything we have is up to speed and ready to go to expand. Now we're in phase 2, where we're going to expand our team and start to take some serious market share. That's how I look at it. Duncan, you want to comment on what we've learned in phase 1?

Duncan Fatkin (Chief Commercial Officer)

Yeah, thanks for the question, Matt. I mean, our focus has been on making sure that the logistics are smooth, the clinical performance is as we'd expected, and the training and everything associated with that continues to go well, which we definitely feel good about that. Certainly, the feedback continues to be that our system is very simple to use, and it doesn't take too long to do the training. We've been refining some of our programs because in the simplicity and ease, sometimes, actually, a lot of the clinicians using the device don't spend as much time as we'd like them to, and so we kind of do some remedial work, and so we refine our program.

We've certainly also understood better the profile of the hospitals that we need to go to make sure that we pick the ideal locations and the ideal partners, which is why we took our time to go to a variety of different types of hospitals. From our perspective, they're probably the main learnings, nothing that has been shocking to us and definitely some optimization that we've done with the device. We're pleased with what we've learned, and now we can really start to expand with I would call it much more confidence.

Matt Kaplan (Managing Director and Head of Healthcare Research)

Okay. I guess with that, how should we think about the contracts converting into revenues over time as you add?

Steve Lisi (Chairman and CEO)

Matt, you know, most of these contracts are going to be annual. You know, if we sign up $600,000, it's going to be $50,000 a month, you know, or $150,000 a quarter. As you sign them, they start to build upon themselves, right? That's how they're going to translate. We, you know, we don't get the cash up front. We don't book the revenues up front, right? This is an annual contract that's spread out over, you know, 4 quarters. You know, we got a bunch this last quarter, we'll get a bunch the next quarter, they'll build on each other, the next quarter, and it'll just keep piling on top.

The more we expand our team, the more people we get trained and out there, the more volume we can have. Every quarter should get better and better from the previous quarter in terms of not just the number of contracts, but the size of those contracts. We're able to handle larger hospitals as well as we get bigger.

Matt Kaplan (Managing Director and Head of Healthcare Research)

Okay. Just shifting gears to Beyond Cancer. You mentioned that you're going to have a phase 1 data later this year. Can you give us some more detail in terms of how many patients and what we should be looking for in that data from Beyond Cancer later this year?

Steve Lisi (Chairman and CEO)

Yes. I don't know exactly how many patients we'll be showing, but, you know, it's going to be, I don't know, you know, give or take 10 patients, you know, maybe a few less, maybe a few more. It'll depend on the cutoff. You know, and I said in the prepared remarks that, you know, it's the immune biomarkers that from an efficacy standpoint, as you know, Matt, this is a safety study, so we'll be looking for safety. And that's the most important thing at this stage. You know, we do want to understand what's happening to the immune system.

I mentioned in the prepared remarks that what we saw on the mice, which we've shown several studies in mice, and you can see on the Beyond Cancer website what the immune markers have done, going in the direction that we expect them to go in by arming the immune system against these tumors. We're seeing similar activity in the immune biomarkers currently in the patients that we have data on so far. I think that's what you want to look for, safety and these immune biomarkers to see if, you know, we're able to predict efficacy going forward. We're pretty excited about it.

I can't wait to show it, you know, we'll have to wait until we complete a few more patients and we get the data in-house, and we get our statisticians to put that data together so we can share it with you.

Matt Kaplan (Managing Director and Head of Healthcare Research)

Okay, very good. Last question, and then I'll jump back in the queue. LungFit PRO, you mentioned in your prepared remarks that the next study that you plan to launch will be a pilot study. What do you hope to learn from this pilot study prior to moving into a pivotal study with the program in the pneumonia setting?

Steve Lisi (Chairman and CEO)

I think the purpose of this pilot study is to give comfort to FDA and to some of the sites we've spoken to, that, you know, the safety is there and that they feel very comfortable treating their patients. Since this is not really a study that's we can go in the literature and see these types of endpoints that we're looking at, this study will also give us the ability to optimize our stats package for the primary endpoint that we're targeting. I think it's twofold there. I think it's to give a little bit more comfort on the safety side. Not for us, we're very comfortable on the safety side, as you see from all the data that we've shown publicly.

It will help inform us on the primary endpoint and give us a little bit more confidence in sizing our study.

Matt Kaplan (Managing Director and Head of Healthcare Research)

Okay, that's great. Thanks. Thanks, Steve.

Steve Lisi (Chairman and CEO)

Thanks, Matt.

Operator (participant)

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

Yale Jen (Senior Managing Director and Senior Biotech Analyst)

Good afternoon, and thanks for taking the questions. For the LungFit PRO, I'm sorry, LungFit PH, you mentioned that you have a number of contracts. Should we anticipate that you report that as a group later on in the next earnings call, or should we anticipate that you will provide some update between this call and the next call in terms of what you get, you know, several contracts being signed?

Steve Lisi (Chairman and CEO)

Thanks, Yale. You know, since the start of fiscal year end, or at the end of, almost at the end of June, and we're going to report early in August, it's about six weeks difference between now and then. I don't know how much update there will be. You would anticipate that, you know, based on, you know, the number of contracts we have, you know, in, we've signed, well, there'll probably be a few more by the we get there August, but it's not going to be a material difference in six weeks. Again, we'll be making progress. I think that, you know, there should be a material difference when we report in November for sure. It's just this, these are very tight, our fiscal year end and fiscal first quarter.

Yale Jen (Senior Managing Director and Senior Biotech Analyst)

Understood. That's helpful. One other thing in terms of You were expecting CE mark later this year, the question is that beforehand, there's a discussion in terms of partnering ex US. Any updates on that front as of now?

Steve Lisi (Chairman and CEO)

I mean, we're getting close to CE mark. The conversations are certainly progressing with ex US partners now that we kind of see the light with CE mark. Again, we don't have it in hand. I think, you know, we will have it in hand in a, you know, September, maybe October timeframe. I think that our talks will heat up, and we'll probably see some kind of a partnership in short order after we get the CE mark in hand. You know, we're pretty comfortable with the profile of the product. I think that our potential partners have seen this profile of the product. They're pretty happy with it, you know, things are moving along. We're pretty.

Yale Jen (Senior Managing Director and Senior Biotech Analyst)

Okay, great.

Steve Lisi (Chairman and CEO)

Duncan with me as well. I don't know if he has anything else to add, but-

Duncan Fatkin (Chief Commercial Officer)

I think that the timing obviously is associated with the CE mark, and there's really nothing that should slow us down. From my point of view, there's no product issue. It's all about this timing coinciding with CE mark availability.

Yale Jen (Senior Managing Director and Senior Biotech Analyst)

Okay, maybe just the last question here, which is about the lung nodule in the cancer. I just want to confirm that, you know, the studies so far. Is it in combo? In other words, it's the UNO plus the checkpoint inhibitor. Is that correct, or are there any single-agent studies, PK and other aspects?

Steve Lisi (Chairman and CEO)

Well, yeah, I mean, there's no PK, obviously, because it's not just, it's not a systemic therapy. Yes.

Yale Jen (Senior Managing Director and Senior Biotech Analyst)

Right

Steve Lisi (Chairman and CEO)

I mean, we've done multiple studies with monotherapy, and even the combination studies that we reported on all had monotherapy arms as well. There's plenty of monotherapy data, and of course, the first in human study is monotherapy. I mean, you can go to the Beyond Cancer website and see all that data. It's, it's all there. It's all out in the open and public, and I encourage you to call the CEO of Beyond Cancer and have a chat with her, and she can walk you through everything. Yeah, there's a lot of monotherapy data, and it's obviously very positive.

Yale Jen (Senior Managing Director and Senior Biotech Analyst)

Right. Right. I'm just talking about the human study that is currently still is, it is in the single-agent part. That's very helpful. Well, thanks a lot. I really appreciate that. Congrats on the progress. Looking forward to see the figures next, not too long from now.

Steve Lisi (Chairman and CEO)

Thanks, Yale. Appreciate it.

Operator (participant)

As a reminder, it is star one to ask a question. Our next question comes from the line of Suraj Kalia with Oppenheimer. Please proceed with your question.

Suraj Kalia (Managing Director and Senior Analyst)

Steve, can you hear me all right?

Steve Lisi (Chairman and CEO)

Yes. Yes, I can, Suraj.

Suraj Kalia (Managing Director and Senior Analyst)

Perfect. Good afternoon, everyone. A couple of questions, one for Duncan and one for you, Steve. Duncan, let me start out with you. Appreciate some of the color y'all have provided on a contract. Maybe if you could expand on it a little bit more. Like, what does the contract really mean in terms of exclusivity, average revenues, utilization? Is $600,000 the right bogey to think about? The subpart of that question, Duncan, would be 150 demos for PH. Consensus estimate for the next year is $19 million, from what I see. Is the right way to think about it, the bogey you need is at least, let's say, 35-40 sites?

Steve Lisi (Chairman and CEO)

Yeah, Suraj Kalia, I used $600,000 as an example. That's got nothing to do with anything. I could have said $300. I could have said $120,000 and said $10,000 a month. I mean, that was just a simple math exercise. I wouldn't read into that number at all in any way, shape, or form. Hospital contracts, of course, mean exclusivity. We have the contract with the hospital. We're the only one there, and our competitors, where they have their contracts, they're the only player with nitric oxide in those hospitals. You know, that's the game. There's no dual supply in the nitric oxide market. You don't have two separate machines in the same hospital. It's quite unique in the medical device arena.

As for, you know, size of contracts, we've said in the past that, you know, with this market, you got about, you know, 1,000 hospitals, 1,100 hospitals or so. It's a $350 million-$400 million market. You can do the average contract per hospital if you really wanna do the math. That's the best way to look at it. I mean, we've been pretty clear on number of hospitals, size of the market. You can back into an average contract size. Please don't take the numbers I gave you in any way to mean that. Duncan, did you wanna comment on any of the other points?

Duncan Fatkin (Chief Commercial Officer)

Yeah, I think that the... Steve obviously explained that, the dynamics, but from a sort of contractual point of view, specifically, I think we said earlier, it's gonna be spread over the annual, you know, monthly rate. It's gonna be a twelfth of the contract, and the contracts are gonna very much depend on the size of hospital. Unfortunately, it's kind of you've seen one hospital, you've seen one hospital. It really depends on how they land. It's hard to predict what the average for us will be because so many variables in each specific hospital. The good news is, once you get them, it's a little bit like an annuity, kind of like builds on itself, and you don't have to kind of repeat until the contract's up.

As we grow, that growth will start to compound.

Steve Lisi (Chairman and CEO)

Suraj, I'll comment on your.

Suraj Kalia (Managing Director and Senior Analyst)

Okay

Steve Lisi (Chairman and CEO)

... your consensus question if you, if you'd like. I don't think consensus is $24 million or whatever you said, but, yeah. You know, we've given guidance, as best we can, you know, in conversations with analysts about how our business works, and they make their own decisions on what they're going to put in their, in their models. So I, we're not gonna control, you know, what you want to put into your model in any way, shape, or form. You know, we have certainly not intimated in any way that this is going to be a massive launch of any size, that this is more of a slow build. Every quarter, we add hospitals, and we build, and we build, and we build.

As we build and get more people, it starts to, you know, accelerate later on. You know, maybe 4, 6, 8 quarters from now, you'll see a pretty big acceleration. This is what we've been saying. We are consistently saying it, so I know there's somebody out there with a number that's close to $20 million for fiscal 2024. I don't know why anybody would consider that a rational or reasonable number based on what we've been saying pre-launch and since the launch. Again, everybody's got their own way of analyzing the market.

Suraj Kalia (Managing Director and Senior Analyst)

Love it. Steve, final question, I'll just bunch a couple of them together. You, in your prepared remarks, you talked about the sites... And maybe I'm paraphrasing here, the knowledge gained from these sites about NO. I'd love to understand, you know, what was the incremental gap you all identified as you all get into phase 2 of commercial launch? Specifically, Steve, a broader question or rather a high-level question, and multiple programs going on, right? We appreciate the color and the progress on all of these. How do you in your vantage point, right, sit and decide on the ROI on the commercial launch of PH versus, you know, ASD versus, you know, other programs? Just kind of walk us through how you are thinking about it. From your vantage point, what makes more sense from an ROI perspective?

Gentlemen, thank you for taking my questions.

Steve Lisi (Chairman and CEO)

Sure. Thanks, Suraj. You know, I'll address your first question. There's no gap in our knowledge about nitric oxide when we launched this program. It was more of we're a company that's putting together, you know, our own customer service, which is 24/7. You know, logistics. No one's ever had a product like this, so it's brand new to any logistics provider. You know, putting together a team that hasn't been together before, highly intelligent, highly experienced nitric oxide people, they still need to gel as a team. Our machine, while coming through FDA, is approved and working great. There are always tweaks you can make.

There are always modifications to ventilators will need to be compatible, and we couldn't do that while we were going through FDA because, you know, the design is frozen, and we need to work with FDA on what we've given them. You don't make changes until later when you can try to adapt and work with ventilators. I mean, this is normal. This is classic for the medical device space and especially for a PMA product. Those are the things that we were learning and honing in on the way we contract, what, you know, listening to the customer and adapting to their needs. We really couldn't talk to them until we got approved. This is pretty standard.

I don't think we did anything different than other companies would do, except maybe a massive company might have been a little faster than us because of the infrastructure, but it's pretty standard. That's why we needed that 6 to 9 months of that first phase where we were learning. As for how we do our ROI, boy, there's a lot of different ways to do ROI. I mean, you can approach it many different ways. There's a lot going on, and nitric oxide is an untapped, you know, part of medicine, in my opinion, and in the opinion of most, if not everyone, at Beyond Air. There's a lot going on with nitric oxide, as you can see in the neuro space now with autism.

You know, this is not something, in our opinion, that takes away from the focus on the launch of the product. That is our number one focus is our commercial launch by far. For Beyond Cancer, their number one focus is cancer. That's why we, you know, we spun that, you know, that program out into its own company because we didn't want to have there be an impact on our Beyond Air activities. That's why it was separately funded, and that's why there's a whole management team and group of people there doing an amazing job. Really, I guess autism is the new kid on the block, so to speak, that is different than what Beyond Air proper is doing with LungFit PH, LungFit PRO, and LungFit GO. This is obviously very early stage.

It was a great opportunity. We love what Dr. Amal at the Hebrew University has done. It's very unique, and really, we hope that when we get into humans, it's going to bear itself out as it did in the mice. If it does, we can really make an impact and make a difference. This is not a very expensive program at this point. It doesn't take a lot of our people at this point. As we go forward over the next, you know, 12-18 months, there'll be a little bit more expense, which we talked about last week when we told everyone about this program, and you can refer to that in our presentation. And it's still not that much of an incremental hit to the people on our team.

Especially on the commercial side, it's got nothing to do with the commercial team at all. The people who support the commercial team, they have nothing to do. The ones who work on autism, you know, we have statisticians and pharmacologists and so forth, and scientists. They're not doing anything for the commercial launch. Yeah, it's a little bit maybe extra for me, but you know, I like to work 100 hours a week, so you know, it's not a big deal for me. I gotta fill my time somehow.

This is a big program, but it's early stage and, you know, perhaps in 12 to 18 months or 18 to 24 months, when we're in a human study and we're getting results, then it might take on a little bit more need and more focus, and that's when the ROI really needs to be discussed. I don't want it to take away from the other programs, but we'll see when we get there, and we'll see how this program progresses. That's kinda how we look at it. Cancer, we realized, was too big for our bridges and at that time, and we moved it over to have a great team run it, you know, people who are cancer experts.

In this situation, I don't think autism has risen to the point where we need so-called autism experts or neurological expertise. I would like to point out that our new chief medical officer has certainly done a lot of work in nitric oxide, actually did a PhD thesis in nitric oxide way back in the day when he was younger and has done work in neurological space with respect to nitric and has done work in other neuro areas that are not nitric related. You know, he brings some expertise there to help out Dr. Amal in Israel and his lab and some of the other people that we have on our team. Again, that's kinda how we look at it, and if there's something that's gonna impact our commercial launch, we just defer. We don't take it.

We don't bring it in-house. It's not worth it.

Suraj Kalia (Managing Director and Senior Analyst)

Appreciate the color.

Steve Lisi (Chairman and CEO)

Sure.

Operator (participant)

There are no further questions in the queue. I'd like to hand the call back to you, Steve Lisi, for closing remarks.

Steve Lisi (Chairman and CEO)

I'd like to thank everybody for joining us today. Thanks for keeping track of us, and we hope to give you some more good news as we go forward. Thank you.

Operator (participant)

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.