Hello, and welcome to the Life Science Investor Forum. On behalf of OTC Markets and our co-host Zacks Small Cap Research, we are very pleased you have joined us for the next presentation of the day, Beyond Air. Please note you may submit questions for the presenter in the box to the left of the slides. You can also view a company's availability for a one-on-one meeting by clicking Book a Meeting. At this point, I'm very pleased to welcome Steve Lisi, Chief Executive Officer of Beyond Air, which trades on the Nasdaq under the symbol XAIR. Welcome, Steve. Thanks very much, Greg. Really appreciate the introduction. Jump right into this presentation. Forward-looking statements, as everyone knows. Look, we are a company based on nitric oxide. Nitric oxide is a medical gas that is used as a pulmonary vasodilator, so it pops open our blood vessels. It's specific to the lung, and you can see a picture of our machine here. What's special about our machine is that we make nitric oxide gas from ambient air. No other system in the world can do what our system does. We will generate this nitric oxide from room air consistently as per the needs of the ventilator. All of the patients that are treated with nitric oxide today are on the ventilator, so this is a critical care space. The market exists. There are other players that use cylinders, you know, tanks of gas. This is about a $350 million market in the US, about $700 million globally, and we anticipate this growing to well over $1 billion over the next 5+ years. Again, one of the other things about our system, besides just generating from room air, is that it does reduce cost and complexity for the hospitals themselves. It's a safer environment for the staff and the patients, much simpler setup, and our sustainability for the environment is far beyond what our competitors can offer. This is a quick snapshot of our cash position. We have $22.3 million pro forma on December 31, $22 million in debt. A lot of that debt is a synthetic royalty, so it's listed as debt, but it's not true debt, so our debt is probably half that number, a little less. We do have patents going out to 2040 with pending patents that could extend us out to 2044 on our LungFit system. This is the market. You can see on the left-hand side, this is the original players. The first three there, these are giant cylinders filled with nitric oxide gas. It is almost all nitrogen with a little bit of nitric oxide, as nitrogen is the carrier gas for this. You can see they're bulky, they're heavy, but they do deliver nitric oxide, so they get the job done. There is a competitor who has introduced mini cylinders. It doesn't necessarily solve the cylinder problem. It just gives you smaller cylinders at four times the number. Four mini cylinders equals one big one, essentially. There is a non-cylinder player. They don't generate from ambient air. They use a chemical substance, which is toxic, and convert that toxic chemical substance to another toxic chemical substance, and then finally to nitric oxide to be delivered to the patient. You notice there are two machines on a cart for this particular competitor. All of the other competitors have built-in backup systems. This competitor needs two systems. Again, nitric oxide is nitric oxide. Really what you're getting here is convenience, safety, cost, saving space in the hospital, and not just saving cost, actual dollars, but saving time for the medical staff. You can see our system. We have one system that is approved in the FDA as well as the European Union and many countries outside of those areas. We also have another machine that we're showing here. I'll give you a closer up look of that machine a little later, but this is our second-generation machine. You can see that it is a lot smaller than the first one, and it has some benefits that will give us a much stronger footprint or stronger ability to take market share than our first-generation system did. I'll walk through that a little bit. Again, I mentioned we have FDA approval. We also have CE mark in European Union. What I wanna mention is that the indication in the United States is only for neonates, so newborn babies with hypoxic respiratory failure. They could be called blue babies, or the acronym I may say is PPHN is the acronym we use for these babies. Outside of the United States, in the European Union and other countries around the world, it is also indicated for right ventricular dysfunction post cardiac surgery. In the United States, that is the main indication, even though it's not on label, it is an off-label indication. The majority of nitric oxide use is in the cardiac surgery space with a smaller portion of it in the newborns, and then other procedures. Lung transplant, for example, will be used as well. What we offer, we compete with our competitors on a monthly fee for service, which is what most of the U.S. market is, but we also offer capital equipment as well. We're trying to be flexible for our customers. Outside the United States, we have 21 partners representing 40 countries, and we are registered to sell in 21 countries. This has all occurred in the past 15 months that we've been able to get this infrastructure up and running. It's pretty fast, and it does take time once you get a partner to go through some local regulatory. Even in Europe, there's still some things to do once you get a partner in a country. There's a lot of training that goes on, both on the engineering side and the clinical support side. This first, you know, 15 months has been setting the stage, and the next couple of months will also be continuing to set the stage until maybe in the back half of this calendar year we start to see some real pickup in the international market as we start to bid on tenders out around the world and start to win some of these. You know, we've certainly set ourselves up for success outside the United States in the past 15 months and we'll continue to do so. We think that 40 countries represented will continue to rise over the next year. Recently our quarterly growth was up 105% year-over-year, which is very nice. We are also pending at FDA for our second generation system, which I mentioned earlier. The second generation system, the main benefit is that it can be used in ground and air transportation. It can be used in an ambulance, helicopter, or airplane. This is important because our first generation system did not have this capability. This was by design, as we wanted to get our first generation system out there, get feedback from customers to build the optimal system, which is our second generation system. Unfortunately for us, the revenues haven't panned out for our first generation system as well as had hoped. A lot of different factors for that. However, we are starting to move, as you can see, with 105% growth year-over-year in the last quarter. We are starting to get the pickup. People are getting excited for our second-generation system. We anticipate that FDA will give us an answer before the end of this calendar year. We're working closely with FDA, and we feel confident that we should see approval before the end of this calendar year. Our mantra is all you need is air. We don't need any delivery of anything to generate nitric oxide and to deliver the gas. We can set our dose in less than a minute and deliver it. In other words, we can get the machine up and running, set the dose, deliver it less than a minute. We have some customers are doing it in 15 seconds. It's very quick to speed to treatment. This is important. For some patients, it's critically important they get on nitric oxide quickly. This also allows more time for patient care since the hospital staff doesn't have to spend time with our machine as they do others. It's a big win. We do have something called an NO2 filter. Nitrogen dioxide is a byproduct of creating nitric oxide with ambient air. Nitrogen dioxide or NO2 is toxic to humans. We have a filter that gets changed every 12 hours. It doesn't matter what kind of ventilator they're using or what the flow rate is or the dose, it's always changed every 12 hours. Again, our machine has a continuous source of nitric oxide. If we run out of ambient air, there's more problems than what we're dealing with our machine. One of the things I'll mention is that the dose is 20 parts per million. We count dose in parts per million since it's a gas. The dose is 20. It can go as high as 80 with the delivery system. All the competitors can do the same thing in terms of dose. All the competitors have the exact same label in the U.S. and around the world. I will mention that only cylinder players are approved right now. What I showed you before was the United States players only. Some of those players are not around the world. A few of them are, and some of them are not. It's a different market outside the U.S. This is how our system works, very simply. You have our machine. We have two generators inside the machine. That's important. Again, if the main system fails, they go to backup. Delivery is uninterrupted to the patient. Okay. You can see we have a compressor that pulls air into the chamber, and we create with just the power needs of a 60-watt light bulb, so any standard electrical outlet. We will create a plasma arc of electricity whereby the nitrogen and oxygen molecules pass through, and they are disrupted and then recombined as nitric oxide or NO. Again, there's the nitrogen dioxide or the NO2 is the byproduct, and there's our NO2 Smart Filter. There'll be a close-up of our machine in a couple of slides. You can actually see where the filter is. This filter is critically important, and the machine will not begin generating nitric oxide unless a filter is present. We do have a patent on the filter. It's called the Smart Filter because there is an RFID chip on there, which is linked to our system, so we need to use our filters for our system. Again, competition. We have ourselves. Here's our filter. Here's the cylinders, which carries the nitric oxide, and here's the cassette or the cassette filled with this chemical substance. It's called dinitrogen tetroxide or N2O4. The conversion of those chemicals happens at the bedside. What you'll see is if you look down, I won't go through this whole table here, but you'll see speed to treatment midway down. You can see we're a lot faster to get to treatment. That 6 minutes is from doing a pre-use checkout. Every time you use the machine, you have to make sure everything's working. There's a formula to follow. You can see we're much faster than our competitors. One of the other things I'll put down is where it's about the fourth line down, it's cassette or cylinder change, where our filters change every 12 hours no matter what. A cylinder can be changed, you know, on a wide range, and the cassette is changed on a wide range. Cylinders can last a long time, so they don't get changed very often. When they do, it's quite cumbersome. Those cassettes get changed quite often, depending on the settings. If you're using high concentrations of nitric oxide or very high flow rates, you'll be changing those cassettes quite rapidly, and they become a burden, and they become very expensive. Again, at your leisure, you can take a look at the rest of this table, but I just wanted to highlight those few things. Again, I mentioned earlier about sustainability, so we do talk about this. This seems to be very important for a lot of hospitals around the world. Again, we have no tanks. That eliminates cylinder storage, saves a lot of space in the hospital, and also the storage room is a special storage room for cylinders. It's not just some random closet. Okay. Zero hazardous materials with our system. We're significantly reduced emissions. We're not shipping cylinders or heavy things and having loads of fleets of trucks going around. Again, we operate with standard electric output, so very simple, and we simplify clinical workflows. We do check all the boxes for sustainability in the hospitals. It's becoming very important. Again, you know, the evolution of our product, right. As I mentioned earlier, the first generation machine was meant to, you know, gain a certain amount of share, a little bit more than we have right now, obviously. It was certainly meant to be a learning experience, so we could optimize and build our second generation system. That's what we have done. Just to give you an idea, you know, we got approval in the middle of 2022, launching towards the end of that year. There are a lot of things that our machine needs to be upgraded with. It took a little time to get those upgrades, get it done. Now our machine is optimized. Now we're beginning to take share, and we're translating those market share gains into optimism for our second generation machine. Here it is. Again, our first generation machine, right now in its current form, can do everything we need except for ground and air transportation. It works for MRI outside of the room. It's not used inside the MRI suite, which our second-generation system will do. Again, our second-generation system will be used for air and ground transport. You can see the filter on our second-gen system sitting on the bottom left side. On the original system, it's kinda tucked up in the bottom right corner. Same filter for both machines. Same number of ports and connections and connectors are the same. Really, the accessories are mostly interchangeable between both machines. We've improved our alarms. We've improved our lighting on the system. Our touch screen is there. We've recessed our ports. We've done something our customers were really adamant about, which was make our backup system as functional as the main system. In our first-generation system, there's limited functionality of a backup system. In this current system, the second-generation, it is almost equivalent to the main system. That's important. In addition, our chamber that I showed you a picture of earlier, where the magic is created. This chamber needs to be swapped out every 1,000 hours. In our new machine, it will be at least threefold longer, so at least 3,000 hours, and we're still testing, so it could be 4,000 or 5,000. We're not sure yet. We'll see how far we can get. That's a big benefit to us and to our customers. Not to mention the size and weight of the system, as you can see. That's our commercial product and our second-generation commercial product. You know, I'll talk a little bit about nitric oxide, some of the things that we would like to be working on that we worked on in the past, but the funding is no longer there. We have another LungFit system for high concentration. I mentioned that the dose is 20 parts per million for PPHN or right ventricular dysfunction for cardiac surgery, and you can go up to 80. When you get up into the 150 to 250 parts per million nitric oxide, nitric oxide's you know, its action in the body changes. It becomes more of an anti-infective. We have done studies in the hospital and in the home where patients treated themselves in their home with our machine. That's how simple it is to use. Very clean, very good efficacy, very safe. We've done studies in nontuberculous mycobacterial lung infection. We've done it in non-CF patients, CF patients. We've done viral pneumonia studies, COVID studies. Nitric oxide is an antimicrobial in the lungs. Breathed at high concentrations around 200-250 parts per million. We have not continued these studies due to funding, but eventually we will go back and do them. I won't go through the mechanism of action slide here about what nitric oxide does in the body, but I will say it is natural inside the body and has multiple functions inside the body. I mentioned we've done studies before. We've actually had over 5,000 nitric oxide treatments at high concentrations, so 150 parts per million and higher. We treated over 170 patients in this lung infection setting. We've had zero serious adverse events related to nitric oxide. None. Very safe in how we deliver. We have two subsidiaries. One of them is, again, nitric oxide related, of course. One of them is a neurology subsidiary. They're focused on autism spectrum disorder. In fact, the main target is Phelan-McDermid syndrome, which is a subset of autism. Also at the bottom there of this chart, you'll see glioblastoma. Glioblastoma is obviously very important, and the data are strong there. We did have a deal with XTL Biopharmaceuticals. We had signed a binding letter of intent for a deal. I won't go through the details of it. That deal did not get finalized. We announced that earlier this week. We will continue to move forward with the program and look for another partner. Lastly, we have nitric oxide in cancer. We're a little further along with cancer than we are with neurology. Neurology is all preclinical. In cancer, we have treated 10 people. We will show the current up-to-date data with these 10 patients at the AACR conference coming up in April in San Diego. This is a prestigious cancer conference. We're very happy to be accepted there, and we're looking forward to showing the data. What we have at least announced to this point is that these were very heavily pre-treated patients, all had metastatic disease, end-of-life patients. We're looking at prior treatments, so surgery, radiation, medication, of over 10 of those. Just medications alone were about almost 6 medications per patient was the average. They had all failed these therapies. We have not yet reached a median survival. The patients are still alive. More than half the patients are still alive. Again, in late April, we will present the full details of this data set. It's very exciting to see what we've done with cancer and looking forward to sharing it with investors. That will bring us to our 20-minute mark here, leaving about 10 minutes for questions. I'll take a look at what you guys have sent in and appreciate the questions that people have brought in. Okay. How should we think about the durability of the 105% year-over-year revenue growth we just reported? That's a great question, right? Because this is, you know, a lot of these markets, especially medical devices, are very choppy. You could have a big quarter and a slow quarter and bounce around. Especially as we gear up for our second-generation machine, I wouldn't dial in 105% growth year-over-year as a constant. We will see those kinds of numbers year-over-year as we get into our second-generation launch. That'll be happening again by the end of this year. That's our goal, pending FDA approval, of course. Yeah, I mean, we're happy about the growth, really happy about it. I think people should be focusing on the second-generation machine and what it can do and what kind of share it can take. I mentioned earlier about international. This is where the first-generation machine can shine. It's a different market. It's a different competitive profile. Certain things that are difficult for us to take share with in the United States for our first-generation machine are not hurdles outside the United States. We anticipate seeing some good jumps maybe a couple of quarters out from where we are now in the international stage. Next question. Mallinckrodt's INOmax has dominated the market since 1999. That is absolutely true. They've done a great job. The question is, what's the biggest objection from hospitals when switching? Honestly, the biggest objection today is transportation or inability to be used in an ambulance or a helicopter or an airplane. We're overcoming that with our second-generation machine. It's that simple. When we first launched, there were other objections because the system was built pre-pandemic and it took years to get it approved. By the time we got out there, a lot of things had changed in the market, ventilators, compatibility with our system and so forth. Those upgrades took a little bit more time given there was a pandemic and the FDA was quite busy with dealing with that. Once we got our upgrades, which we have now and our system is as best as it can be, the real only massive objection is the transportation. Like I said, our second-generation machine will overcome that. We have 21 distributor contracts covering 40 countries and we're seeing repeat orders. What does that say about product stickiness or the potential for operating leverage internationally? Yeah, look, I mean, the repeat orders are just starting. I mean, we're just getting going internationally and it takes time, right? We send our people around the world for training to help our partners and it does take time. You know, for example, right now, you know, what's happening in the Middle East, we have partners there. That's, you know, these things will probably take a pause with our system while these things are going on over there. There's always something happening around the world. It's, again, it'll be choppy, but there's a lot of leverage internationally for sure. Absolutely. I wouldn't look for it in the next, you know, two or three quarters. I think that, you know, we've set a great pace. We've planted a lot of seeds around the world and we're going to continue to get regulatory approvals of countries over the next year and we'll start to see us winning some tenders and getting some more growth internationally. We turned a gross loss to a gross profit this quarter. How quickly do you think gross margin can move from mid-teens% towards your longer-term targets? That's a great question. I think that the switch from Gen 1 to Gen 2 really is going to be where we see the margins go because Gen 1 will do really well. But as we're getting close to the Gen 2 launch, we're going to have to see that launch occur before we see our gross margins get up into that, you know, into the 60s% with our Gen 2 system. I think that's where we'll probably be 60+% gross margins at that time. Give us a little time post the Gen 2 launch. A question about international agreements. What internal goal do we have for revenue-generating countries by the end of 2026? I think I read that as how many revenue-generating countries will we have by the end of 2026? Right now we've got about 4 or 5 that have just started to go into hospitals and reorder things. I think we probably can get up to about 12 countries are gonna start reordering, accessories, because they have use. So that's probably around the number we'd be at the end of 2026. Again, we have lots of countries and partners, but it does take time to train them, get certain regulatory approvals. Even with a regulatory approval, there are other things that need to be done for importing and so forth, labeling. As more real-world LungFit PH data accumulates, do you see a role for health economic studies to support premium pricing or faster formulary adoption over legacy cylinder systems? Yeah. I mean, this has been on the market since 1989, as someone mentioned in a question earlier. I don't know how much more of these health economic studies are going to improve. Again, I think it's not about can we move nitric oxide to a higher price point. I think it's about taking share away. When it was a monopoly for Mallinckrodt, it was very expensive, probably 3-4 times where the price is now. You know, hospitals used a drug called epoprostenol for acute pulmonary hypertension settings where nitric oxide is considered standard of care. This was a cost issue for sure, and also an ease of use issue. With our system, we're starting to see hospitals move away from the epoprostenol and move to the LungFit, and that's a good sign. I think that's where you're going to see volume growth. I think the price is pretty good. Even though it's down, way down from when Mallinckrodt was a monopoly, the margins are still very strong. I don't really see health economic studies making an impact. Now that we're on Premier, how are your sales conversations different versus before? Yeah, I mean, great. We're moving with Premier, and Premier hospitals are engaging with us. It's been about seven months, eight months since we've been on Premier, so we certainly see a lot of conversations going on with Premier. You know, we hope to continue to win with the GPOs, not just Premier and Vizient, but hopefully we have more this year as well. Can you share the current situation and future expectation about Beyond Cancer? Sure. I just mentioned, you know, Beyond Cancer will be at the AACR next month, showing the data. We are searching for places to do our next study in combination with a checkpoint inhibitor. I don't know when that will start. We may do it alone, may do it with a partner. We'll see. Stay tuned for that. We're working on it. I don't really have definitive timelines at this moment. Sorry for that. Our next question, looking across LungFit, Beyond Cancer, and NeuroNOS, where do you see the greatest potential for upside surprise versus what the market is currently pricing in? I mean, the market's currently pricing in right now. There's surprise everywhere, right? LungFit is certainly in our opinion, the LungFit second-generation product will dominate in the United States. We're highly confident in that, and we should do well internationally with the first-generation LungFit. I think people are focused on the next quarter or two, and they should be focusing on the next year or two of what we're going to do, right? This is a medical device. These things take time, and we're here. We're at the precipice of our second-generation machine, which is our goal from the beginning. I think people should be looking at this and saying, "Where are we gonna be in 2-3 years?" Not, "Where are we gonna be in 2-3 quarters?" With respect to cancer and NeuroNOS, I mean, cancer is further along. I think that's the bigger upside at this moment in time. You know, you look out 3 years, it could be a different story. Right now, with Beyond Cancer and the data we're about to show, I think there's potential upside there for sure. Operating expenses are down 36% year-over-year. How much more room do you see to expand margins from cost discipline? I think we're close to the bottom, maybe a quarter or so more of a little bit more of expenses going down. We're doing a good job of it. You know, come the June quarter and September quarter, we're gonna be gearing up, getting ready for the gen two launch. I don't see the operating expenses going down much further than where they were last quarter. Are hospitals primarily choosing monthly fee for service model or capital purchase? Right now they're doing monthly fee for service model. We've introduced the capital purchase. I think, you know, it's new for hospitals with respect to nitric oxide, so it'll take some time. Again, I think the capital purchase will do a lot better with the second-generation machine than the first-generation machine. Which is more profitable for Beyond Air? They're about the same. Just with the capital purchase, you get a little bit more money up front. Otherwise, you know, over five years, profit margins are roughly the same. LungFit PH is already FDA and CE marked and in active hospital use. What does a typical ramp look like from first install to meaningful recurring revenue at a given hospital? I think you're talking about internationally, but internationally, you know, you'll get a first install in a country, and that's gonna be the reference hospital. What we've seen is they'll get in that first hospital or two, and we'll probably wait six months before they get comfortable with it and start advocating to other hospitals in the country for us. It does take time, and I appreciate that question 'cause this isn't like, you know, you don't flip a switch, and everybody starts using the product. Again, this is critical care market. These patients, you know, are on their deathbed, some of them. I'm sorry, but I think we're running up against time. I don't know if I have time to do any more questions, but apologize if I didn't get to your question. patients, you know, are on their deathbed, some of them. I'm sorry, but I think we're running up against time. I don't know if I have time to do any more questions, but apologize if I didn't get to your question. patients, you know, are on their deathbed, some of them. I'm sorry, but I think we're running up against time. I don't know if I have time to do any more questions, but apologize if I didn't get to your question.