Good afternoon, and welcome, everyone to the Beyond Air Financial Results Call for the Fiscal Quarter Ending September 30, 2024. At this time, participants are in a listen-only mode. A question-and-answer session will follow the form of presentation. And now, I would like to turn the call over to Corey Davis, LifeSci Advisors, please go ahead.

Thank you, operator. Good afternoon, everyone, and thank you for joining us. Today we issued a press release announcing the operational highlights and financial results for Beyond Air's second quarter of fiscal year 2025. A copy of this press release can be found on our website www.beyondair.net under the News & Events section. Before we begin I'd like to remind everyone that we'll be making comments and various remarks about future expectations, plans, and prospects which constitute forward-looking statements for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. Beyond Air cautions that these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated. We encourage everyone to review the company's filings with the Securities and Exchange Commission, including, without limitation, the company's most recent Form 10-K and Form 10-Q, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. Additionally, this conference call is being recorded and will be available for audio rebroadcasts on our website, beyondair.net. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, November 11, 2024. Beyond Air undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call. With that, I'll turn the call over to Steve Lisi, Chairman and Executive Officer of Beyond Air. Go ahead, Steve.

Thanks, Corey, and good afternoon to everyone joining us. With me here today is Larson Larson, our Chief Financial Officer. I'm excited to report that the Beyond Air team is successfully executing our commercial strategy and building positive momentum. As a result, during the quarter ended September 30th, 2024, we increased our total number of hospital clients by over 60%. This is a tremendous signal to our team that the recent improvements we implemented in our marketing and customer education programs are striking the right tone with our customer base. Also, we are pleased with how our LungFit PH device is operating following the upgrades we made about six months ago. As all of you may recall, our new Chief Commercial Officer joined us in July, and we are very pleased that the strategic initiatives put in place are having an immediate impact on customer receptivity, which has started to flow through the channel in the form of contract negotiations. We expect this success will continue to drive accelerated top line revenue growth over the following quarters as our recent sales and marketing initiatives mature. In addition, we announced several partnerships, including with Healthcare Links, a renowned health care advisory and contracting firm that works with GPOs and IDNs, and TrillaMed to help us engage with and distribute to the Military and Veterans Administration hospitals. And we're teaming up with business Asia consultants to provide LungFit PH to hospitals in Europe, South America, the Asia Pacific region, and the Gulf Coast region, where many hospitals are unable to obtain natural oxide supply or use NO due to the difficulties associated with legacy cylinder systems that can't generate NO from ambient air like LungFit PH. We are also implementing additional strategic initiatives over the next few months that are expected to build on our momentum that will further separate us from the competition. So stay tuned. To best position ourselves for success, we recently announced three separate financial agreements that are expected to extend our cash runway. First, we completed a private placement equity offering for $20.6 million with a select group of health care-focused investment funds and company insiders. Second, we reached an agreement with Avenue Capital to extinguish their senior secured term loan for a onetime payment of $17.85 million. This agreement eliminates payments that would have been made from October 1, 2024 through June 30, 2026, of approximately $12 million. Avenue Capital also participated in a private placement equity transaction I just mentioned. Third, we entered into an $11.5 million royalty funding agreement led by certain Beyond Air Board members. This debt will carry a 15% interest rate with 12% being payment in kind until the September 2026 quarter. Actual cash payments for all interest in principal will commence after the September 2026 quarter and will be determined based on an 8% royalty rate on sales of LungFit PH. These royalty payments will continue only until principal and interest are paid off. The outcome of these financial agreements, combined with the cost reduction measures taken earlier this year and anticipated revenues, is that we expect to have sufficient cash for about 18 months as we ramp up our global commercial execution plan. Before turning it over to Doug, I want to touch on some growth drivers we are expecting in the relative near term. Our PMA supplement for the expansion of the LungFit PH label to include cardiac surgery was accepted and is under review by the FDA. As a reminder, a PMA supplement is a submission for when there is a change to an already PMA-approved medical device. While there is no firm date for the FDA to complete its review, we can say that as of today, we have answered all questions posed by the FDA, and we await their feedback. We will work with the FDA to provide the quickest timeline possible, but cannot give a specific date for an FDA decision. As you may recall, there are no nitric oxide products currently approved for cardiac surgery in the United States. So, if granted, this would represent the first formal FDA approval among any of the current players in the market. CE Mark. The regulatory changes in the EU for medical devices have been difficult for everyone. However, we believe that we will receive a final answer before the end of this calendar year. I know the frustration from investors on this topic, but from my view, the Beyond Air team's performance was a lesson in patience, perseverance, and being an expert at your craft. Before the end of the March 2025 quarter, we will file a PMA supplement to the FDA for our next-generation LungFit PH system. We look forward to demonstrating this system next week at the AARC Annual Meeting in Orlando for those attending our private meetings. We believe, and we expect those of you who attend AARC and see for yourselves will agree that this superior system will be rapidly adopted in the global nitric oxide market. Moreover, it can provide NO to areas of the world where cylinders just can't be used, and this will result in lives saved. Turning to Beyond Cancer, they are awaiting regulatory approval in Israel for their UNO program in combination with anti-PD-1 therapy in late-stage cancer patients, which remains an area of high unmet patient need. Just the other day at the Society for Immunotherapy of Cancer Meeting, compelling survival data in both rats and mice were presented. We were encouraged to see that the amount of gas used was less than 10% of the amount of gas used in the Phase 1a UNO monotherapy human study where an acceptable safety profile was demonstrated. This lower volume administration may be even safer and allow for tumors to be treated in more areas of the body than just cutaneous and near cutaneous. I encourage all of you to visit the Beyond Cancer website and get better educated, as 2025 should be transformational for this potentially groundbreaking therapy for those suffering from solid tumors. I am also pleased with the advances that NeuroNOS, our subsidiary focused on therapies for Autism Spectrum Disorders, is making. Great early-stage work continues at NeuroNOS, and I encourage you all to visit their website to get a better understanding of what is to come over the next 12 to 24 months. In closing, let me summarize my comments on LungFit PH sales by saying our commercial operations in the U.S. turned the page about six months ago, and we are energized by the steady flow of high-quality engagements with potential new customers and by the extremely positive feedback from existing U.S. customers. In addition, the interest we are seeing outside the U.S. is quickly gaining traction since our system upgrade, and we anticipate signing new ex-U.S. agreements over the next six to 12 months and begin shipping systems overseas in the first half of calendar 2025. In addition, we have several upcoming regulatory and product development milestones that are expected to drive increased growth. When we take all of these factors together, I hope you see why we are so excited about what we are planning over the next year. Now I will turn it over to our CFO, Doug Larson.

Thanks, Steve, and good afternoon, everyone. Our financial results for the second quarter of fiscal year 2025, which ended September 30, 2024, are as follows. Revenue for the second fiscal quarter of 2025 was $0.8 million as compared with $0.2 million in our fiscal second quarter of 2024. We're showing a $1.1 million loss in gross margin for the fiscal second quarter of 2025 compared to a $0.2 million loss for the same period last year. Cost of revenue in the current fiscal year exceeded revenue, primarily due to $0.7 million of one-time costs required to upgrade our existing fleet of devices, plus $0.8 million of non-cash headwinds, either provisions for excess inventory or depreciation of devices purchased but not yet deployed. We expect gross margins to turn positive in the March 2025 quarter. Research and development expenses for the three months ended September 30, 2024, were $4.6 million as compared to $7.1 million for the three months ended September 30, 2023. The decrease of $2.5 million was primarily attributed to a decrease in spend in salaries, stock-based compensation, and preclinical studies. SG&A expenses for the three months ended September 30, 2024, and September 30, 2023, were $7.2 million and $10.2 million, respectively. The decrease of $3 million was attributed primarily to a decrease in stock-based compensation costs. Other expenses for the three months ended September 30, 2024, were $1.2 million compared with other income of $0.1 million for the three months ended September 30, 2023. The increase in expense of $1.3 million was mostly non-cash and attributed primarily to the partial extinguishment of the Avenue loan. Net loss attributed to the common stockholders of Beyond Air, Inc. for the three months ended September 30, 2024, was $13.4 million or a loss of $0.28 per share basic and diluted. Our net loss attributed to common stockholders of Beyond Air, Inc. for the three months ended September 30, 2023, was $16.2 million or a loss of $0.51 per share basic and diluted. Net cash burn in the quarter ended September 30, 2024, excluding one-timers and the impact of the financing transaction Steve mentioned earlier, was $11.5 million. We hit the brakes hard on spend in the last two quarters, closing two offices, reducing staff levels by over 30% across the company, putting our VCAP study on hold, and adjusting our production forecasts. We'll get a full quarter of benefit from all of our actions and expect to see a reduction in cash burn in Q3 by at least one-third. As of September 30, 2024, the company had cash, cash equivalents, and marketable securities of $28.4 million. Due to the timing of cash settlements associated with the financial transactions mentioned earlier, certain settlements were completed subsequent to quarter-end. Thus, on a pro forma basis, for September 30, 2024, cash was $18.5 million. And with that, I'll hand the call back to Steve.

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

Thank you. We will now be conducting a question-and-answer session. Our first question comes from Jason Wittes with ROTH Partners. Please proceed with your question.

Hi. Thank you for taking my question. You mentioned a 60% increase in contracts. What does that indicate about the momentum for the rest of the year? Should we expect that growth to continue in the upcoming quarters, or how should we view the development from the first quarter to the fourth?

Yes. Jason, thanks for the question. I think that momentum will continue. Again, every contract has its own value. So I think that the volume is very good. And I think the volume will continue at this pace. Obviously, as the denominator gets bigger, maybe the percentage may not keep up, but the number of contracts that we're adding every quarter will continue. The current quarter that we're in is close to what we had last quarter, not quite there yet, but we still have another seven weeks left.

Okay. And then you mentioned several strategic partnerships. Just curious how they might work, especially with the VA. Are you in the VA now? Or is the TrillaMed partnership going to get you into the VA?

We do not have any VA hospitals yet. The relationship with TrillaMed has just begun. TrillaMed was crucial in helping us secure the naval hospital in Guam, which was a significant achievement. However, we still have some work to do with the VA, so I wouldn’t anticipate a substantial impact in the December quarter from the VA. The TrillaMed agreement is still in its early stages, and we need to progress further with them before they can fully engage.

Okay. You mentioned that the timing for the PMA for cardiac surgery largely depends on the FDA. What are your thoughts on how that might develop?

Yes, we have provided everything they requested. The responsibility now lies with them. However, this is a device, not a drug, so there isn’t a fixed approval date, which makes it hard to provide a specific timeline. I wish I could give more details, but our previous guidance on regulatory timing hasn’t been very successful. We will update you with what we know, which is that we've submitted everything they needed, and now we just wait.

Okay. Great. I'll ask one more question and then get back in the queue. Regarding the comment on cash burn, I understand that it will reduce by about a third. Is most of that reduction in the SG&A line, or should we expect to see it in other areas as well?

Yes, you're going to see it all over the place. I mean, Steve and I went through with a knife basically to the entire P&L. So we've looked at everything where we could make savings. So you're going to see it in the R&D line, you're going to see it in G&A.

Okay, great. I’ll jump back in queue.

Thanks, Jason.

Our next question comes with the line of Jason Bednar with Piper Sandler. Please proceed with your question.

Hi, guys. This is John for Jason. I just had a couple of questions on the competitive landscape here. So one of your big peers referenced some good traction with the recent product launch. Can you talk about what you're seeing out there in the market with respect to competitive dynamics and whether the presence of this new offering is leading to any longer contract negotiations with hospitals? Thanks.

I’m not sure who is gaining traction in the market without knowing the specific competitor you have in mind. Our relationship with hospitals and customers hasn’t changed; we haven’t noticed any difference related to company fundraising on Wall Street. What has changed is the enhancement of the new strategies we implemented earlier this spring, especially with the support of our new Chief Commercial Officer who joined us in July. We've received positive feedback from these initiatives and the upgraded machine, leading to increased momentum in our discussions with customers in the U.S. We are optimistic about this. Additionally, as we mentioned in our prepared remarks, we are experiencing significantly more activity on the international front compared to six months ago. If you have any specific competitor in mind, feel free to share, and I’ll be glad to discuss further.

No, we can take that offline, Steve. That's all right. But I appreciate the color there. And just to follow up to that one. Can you also talk a little bit about contract pricing? With the uptick in activity in the most recent quarter, kind of piggybacking off the last question. Has there been any movement up and down here in pricing versus earlier this year? And can you talk about how this pricing is fluctuating across account sizes?

Yes. I believe that the pricing per hour is as we anticipated. We aren't observing any significant changes compared to six months or 12 months ago. It appears to be quite stable from our viewpoint. However, the size of contracts relies on the volume of the hospitals; generally, higher volume leads to lower prices. We prefer the higher volume contracts because they are larger. You'll see how this develops for us in the next quarter or two regarding the sizes we're securing.

Great. Appreciate that.

Thanks.

Thank you. Our next question comes from the line of Marie Thibault with BTIG. Please proceed with your question.

Hi. I appreciate you taking the questions this evening. I wanted to ask a qualitative question here on some of the changes David has made to the commercial organization. What strategies specifically are working well? Where are you finding success? And where is there sort of more to come? I assume that he hasn't had time to deploy all his strategies yet. So I'd love to hear a little bit more about what's going on behind the scenes.

We recently established a partnership with an international distribution firm that will oversee our relationships outside the United States, which is a significant achievement for us. There are not many high-quality firms to choose from, and BAC stands out in that regard. This effort is led by David, and though building these partnerships takes time, we anticipate increased international activity in the next three to six months. Additionally, TrillaMed and Healthcare Links will assist us with not only the VA and Department of Defense but also GPOs and IDNs, which are critical for our success. While we haven't seen much impact from these agreements in this quarter besides the naval hospital base in Guam, we expect to see progress moving forward. David has also successfully generated more leads in the United States with recent initiatives he launched about a month ago. I won't disclose the specifics to respect his efforts, but he has effectively increased interest and leads for our commercial sales team. We expect these efforts to yield results in the next three to six months, and while we are starting to see some benefits from his groundwork already, it's just too soon to reflect those in this quarter's reporting.

Of course. Well understood. Thanks for that Steve. A question for Doug then. Can you talk to us a little bit about gross margins and how we might expect some of that to be impacted by, say, both higher volumes to come, but also some of these label expansions, the transport-ready system, the CE Mark and selling abroad. Any impact to gross margins to expect over the next few quarters? Thanks so much.

Sure. As mentioned earlier, there are a couple of challenges we're facing. One significant item is the cost of upgrading our existing systems, which amounted to $700,000. It's not entirely a one-off expense since we're not fully done with the upgrades, which is why we're projecting that gross margins will improve in the March quarter rather than in December. We expect some additional costs next quarter, but these should mostly be resolved by March. Additionally, there is about $500,000 in depreciation for this quarter on systems that we’ve already built and are ready for deployment, which is currently impacting our gross margin. The positive aspect is that as we enter the market, we won’t need to build as many new machines; we can simply deploy the existing ones, which will contribute directly to improved margins without incurring further depreciation. There are also some fixed warehousing costs affecting our gross margin, but as we grow in the regions where we already operate, we can do so without significant extra costs, thus increasing our gross margin rate. However, as we expand internationally, there will be a slight drag on gross margin compared to the U.S. market due to differences in our business model. This international impact will grow gradually, but between now and the fiscal year-end, we don't anticipate a substantial effect as shipments will begin in the March quarter. It's important to consider this potential impact as we aim for greater success internationally.

Very helpful. Thanks for taking the questions.

You bet.

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

Good afternoon and thank you for the questions. Steve, regarding the 60% increase you mentioned, could you provide some additional details about whether that figure is compared to last year or how we should interpret that number?

Yes. So the base is just our total customers as of June 30 versus our total customers at September 30. This year, that's all.

Okay. Great. So basically, the quarter-over-quarter, I guess, that's one way to look at it?

Yes.

Okay, great. That's very helpful. In the press release, you're mentioning annualized revenue for October. Can you provide more details on that aspect? It appears it will exceed $800,000 per quarter. Should we anticipate that for the fiscal third quarter, or are we potentially underestimating it?

Yes. I mean we did $800,000 this quarter, and the run rate would put us more like $875,000. And we did say that we have some more starts after October 1. So the number will be higher than that. How much higher, we don't know because we don't know all the starts. We may get some hospital starts in December right now. So we're still waiting. So yes, I mean, we'll be talking about that kind of a run rate thing every quarter. So you can see how we progress. So we think that every quarter, it's going to continue to rise.

Okay. Great. That's hopefully helpful. And then maybe the last question here is in terms of your international sales, I know you have TrillaMed. Are you guys going to have using this firm to expand the footprint to other countries or you are still seeking any kind of formal sort of collaborator partners and that kind of things? And I just wanted to get a little bit of color as you guys move forward go beyond the U.S. borders. Thanks.

Yes. Thanks, Yale. So BAC is more of an intermediary between us and the actual distributor in each country. We started to see the demand come in as we showed our upgraded system back in the spring. And we had one person doing international for us. We had the Getz deal in Southeast Asia. We had a few other things that were happening. And it just became apparent to us over the summer that he's only one man. So we needed some help. And that's why we contracted with this group, and they can handle any volume that comes our way. We're fortunate to have as much as we think. So they are the intermediary. They've got a great track record, and we're looking forward to them getting going over the next 30 to 60 days.

Do you need additional approval in countries outside the U.S.? Or do you believe that the U.S. application, perhaps the EU application, will cover many of these non-U.S. countries or territories? Thank you.

Yes. So FDA approval covers some. I think the CE Mark, the EU covers more than just FDA approval. And there's another regulatory approval. It's called MDSAP. We anticipate having that as well sometime next calendar year, maybe late next calendar year, which will open up a few other countries. But in most countries, you still need to go through their licensing process. So it may take a couple of months to maybe even a year in some places. So every country is different. And of course, as you know, Japan has their own process. So FDA in Europe will not make a difference there, and there might be one or two other countries where it's going to be a long process. But for the vast majority of countries, it's a couple of months to maybe a year. And once we get our CE Mark, then we'll have most of the countries in the world covered outside the U.S.

Okay, great. Well, appreciate that. And again, congrats on the progress at this moment.

Great. Thanks, Yale.

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

Thank you for taking the questions. Can you provide more details about the next-generation device, the transport-ready device, and the PMA supplement you plan to submit in the first quarter of next year? Could the review process be quicker for this supplement compared to the first generation?

Thanks for the question, Matt. Boy, it better be faster than the first one. The first one was torturous. But again, that was a difficult time for the FDA with the pandemic and lots of changes going on over there. So I think they're in better shape staffing-wise than they were back then. So we're looking forward to working with them on the supplement. But yes, it is a supplement. It's not a new product. So it should be a little bit smoother. I don't know the timing. I don't want to speculate. Let's just get it to them and see what they think of the filing of the quality of it, and we'll go from there. But this is a product that we'll be showcasing next week at the American Academy of Respiratory Care in Orlando. So if anybody wants to make the trip down to Disney, you can come see us, and we'll give you a look at this system. It is ready. It's ready to go. So you'll see it fully functioning next week. And we're just putting together all the external testing from our external partners who do the testing for us, and then we'll put it into them in a couple of months.

Okay. You mentioned in your prepared remarks about the anticipated accelerated revenue growth in the upcoming quarters. Can you provide more details on that? Will it come in big increments as you secure new contracts? Or do you expect it to be more gradual? Please share more information on this.

Sure, Matt. I wish I could. I mean, I'd love for it to be as smooth as it can be and give you a nice little chart, but it never works that way. It's probably going to be chunky. We may one quarter get one or two real big contracts, and in the next quarter, still keep up the volume of hospitals growing, but we might not hit a big home run in the next quarter. So you just don't know. I wish I'd give you more insight into how smooth it is, but the size of contracts range from less than $100,000 a year to over $1 million a year. So you just don't know which ones are going to hit in what quarter. But we're talking to as many hospitals as we can, trying to reach out to as many potential customers as possible, and there are potential wins across the range of size of hospitals. So we'll just have to see how they come in.

Okay. Lastly, regarding the expectation that margins will turn positive by March 2025, how should we anticipate the progression of margins throughout the calendar year 2025?

Thanks, Matt, for the question. You're asking about calendar 2025. We expect to have positive margins in the March quarter. Moving forward, you'll see margins that you've probably been anticipating from us, starting in the first quarter of fiscal 2026.

And let me just help out here. I mean we've said publicly in the past that we're targeting with our first-generation product, 60% to 65% gross margins. So that's the target. And I think by the end of calendar 2025, on a GAAP basis, you probably could see that. I think giving Doug a little wiggle room here, the international impact, there is always the cost-plus component of international. So that may bring the margin down. It just depends on how we structure the back end of that, whether it be a royalty or we're doing a razor-razorblade type model as to whether the impact on the gross margin will be muted or not. So it might be a good thing if that gross margin is a little bit light because we're so strong internationally. So we'll just have to see how it plays out. But I think that by the December quarter of calendar 2025, you should see us close to that 60%-ish number.

Okay. That's great. That's helpful. Thanks for taking questions.

Great. Thanks, Matt. Appreciate it.

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

Thanks for joining today, everyone. I look forward to speaking to you in a couple of months. Thanks.

Thank you. And ladies and gentlemen, this concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.