Beyond Air, Inc.

Good afternoon and welcome everyone to the Beyond Air financial results call for the fiscal quarter ended March 31st, 2024. At this time, participants are in a listen-only mode. A question and answer session will follow the formal presentation. And now, I would like to turn the call over to Garth Russell, LifeSci Advisors. Please go ahead.

Thank you, operator. Good afternoon, everyone, and thank you for joining us. Today, after the market closed, we issued a press release announcing the fiscal year 2024 operational highlights and financial results. A copy of this press release can be found on our website, www.beyondair.net, under the news and events section. Before we begin, I would like to remind everyone that we will 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 Allegation Form Act of 1995. Beyond Error 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 limitations, 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 rebroadcast on our website, www.beyondair.net. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, June 24, 2024. Beyond Air undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call. I would also like to mention, considering the corporate update being provided to you today, in a relatively short period of time until the company is going to announce its Q1 fiscal year 2025 financial results, management has decided to forego hosting a standalone conference call next month. The company's results will still be thoroughly communicated via press release and 10Q filing with the SEC. With that, I'll now turn the call over to Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. Steve?

Thanks, Garth, and good afternoon to everyone joining us today. Joining me on the call is Doug Larson, Chief Financial Officer, and we're both happy to be here today. I'm excited to report that we closed out our fiscal year 2024 with positive momentum, as revenues for the fiscal fourth quarter grew more than 20% sequentially, and we reported several positive metrics across our growing lineup of existing customers and sales pipeline, which I will touch on in a moment. I would like to offer a short review of the road we've taken to get to this point. We launched LungFit PH following FDA PMA approval in the fall of calendar year 2022. Immediately after FDA approval in mid-22, our engineers worked diligently to expand the device's compatibility with additional ventilators already installed in the market and made certain other improvements that addressed the feedback we received from real-world use and customer input. In the spring of 2023, we had received all we needed from FDA to make our system what we believe is the best on the market, with two notable exceptions, compatibility with an important ventilator and improved nitric oxide sensors, both of which were tied to a pending software approval. Then in the fall of calendar 2023, which is the third quarter of our fiscal 2024, the FDA gave approval for this update. Thus, we are now in the market with a more optimized product. As you all know, with a PMA-approved Class 3 medical device, the implementation of this software change required more than simply uploading files from a thumb drive. We spent several months ensuring perfection, working with our existing customers to be certain the updated system worked perfectly. Once we had that performance indication, we upgraded the devices at all of our existing customer locations. and brought on new customers as well. This took a little longer than expected, but we believe that the quality of the system we now have is paramount for medium and long-term success. Overall, we believe LungFit is well positioned for rapid gains as we expect that it meets all the existing market needs. Now let's talk about our confidence for the next several quarters and beyond. Over the past few months, since the updated LungFit PH system has been available, we have seen a steady flow of high-quality engagements with potential new customers and extremely positive feedback from existing customers. The level of satisfaction among our existing customers is important as word-of-mouth referrals and reference checks are sometimes the most effective form of marketing to hospitals. Momentum is building, and we are ready to seize the moment. We are confident that our newly appointed Chief Commercial Officer, David Webster, who begins on July 8th, will build upon this newly cemented foundation and on our success to date. Now I will fill you in on some quick statistics. More than 50 hospitals in the United States have used LungFit PH to treat patients. These hospitals collectively have now treated over 1,100 patients. This translates to over 75,000 hours of therapy with LungFit PH. Clearly, LungFit PH works in multiple settings while being used with various ventilators, and hospital staff are pleased with LungFit's benefits. Also, it's worth noting that most of these hours were done with LungFit PH prior to the recent updates, so just imagine how much more satisfying it is for hospital staff to work with the upgraded system. Perhaps most telling, continuing on our discussion of engagements from our last earnings call, every hospital that uses LungFit PH that had their contract conclude has renewed with us. And the number of multi-year contracts has increased by over 100% since our last conference call, with such requests becoming more frequent. We are proud of our continuing performance and the quality of LungFit PH. And to be crystal clear to all of our potential customers, we welcome all head-to-head comparisons with any competitor's NO device under any circumstance. Now, a few things about our new chief commercial officer, David Webster, and why we believe he is absolutely the right person to lead the commercial team. We were fortunate to have had several very capable candidates participate in the extensive vetting process for the job. While all the candidates were extraordinary, David's record of success and demonstration of leadership qualities led us to believe that he will drive the success of LungFit PH. He has extensive experience bringing products to market in the hospital setting, and working within small to medium-sized companies. He also has built commercial teams from the stage where we currently are, with customers in 10 states to full-sized, well-oiled machines covering the entire United States. I look forward to having David hit the ground running in two weeks. In addition to having a well-qualified chief commercial officer at the helm, we also have a couple of other upcoming events that should further drive growth. Remember that our PMA supplement for the expansion of the LungFit pH label to include cardiac surgery was accepted and is under review by the FDA. While there is no firm date for FDA to complete its review and timelines may change, based on our interactions with the agency to date, we expect a decision in the fourth quarter of calendar 2024. Recall that there are no nitric oxide products presently approved for cardiac surgery in the United States. Looking outside of the U.S., CE mark for lung fit pH remains pending, and we continue to work collaboratively with regulators. While we don't presently have clarity on updated timing, we have learned to be patient given the overhaul of the EU medical device regulations that occurred a few years ago and the learning curve of the European notified bodies as everyone navigates the new rules. As we have mentioned previously, in addition to opening up doors in Europe for our system, receiving this CE mark will trigger a milestone payment from our partner, Getz Healthcare. which has signed an agreement with us to commercialize the LungFit pH in several countries in the Asia Pacific region, excluding Japan. As I look ahead, while we continue to make significant strides forward, delays in reaching our milestones have left us slightly behind our previous near-term targets. Due to this, we are revising our fiscal year 2025 revenue guidance to greater than 10 million, down from 12 to 16 million. I will now address our cash burn. Preserving capital is critical for us at this juncture in our evolution in this current market. We began our analysis in January of how we could most effectively preserve capital and give our new chief commercial officer a runway to succeed. Since then, we have reduced our headcount by over 20% with most of the moves occurring in the June quarter. Most of the associated costs, including severance payments, will be recognized in the June quarter. the first quarter of our fiscal year, resulting in what we expect to be the largest cash burn of fiscal year 2025. Conceivably, the decrease in our bank balance in the June quarter may end up being more than the other three quarters combined. To reiterate what was in the press release earlier today, the impacted R&D projects include the LungFit Pro program, which is on hold, and LungFit Go, where all engineering has been brought in-house, which resulted in a delay until 2026 for the next clinical study start. The LungFit PH transport-ready system is on track for FDA submission on or about December 31st, 2024. Beyond Cancer's UNO program is nearing the end of Phase 1A and is targeting initiation of a Phase 1B combination study with anti-PD-1 therapy prior to the end of calendar 2024. Neuronos, Beyond Air's subsidiary focused on autism spectrum disorder, is still moving towards a first-in-human study in 2025. Beyond Cancer and Neuronos are focused solely on their respective human studies and in alignment with Beyond Air's focus on careful cash management. Now an update on Beyond Cancer. Data were recently announced from its phase 1A study evaluating ultra-high concentration nitric oxide, or UNO, in subjects with advanced relapsed or refractory unresectable primary or metastatic cutaneous and subcutaneous solid tumors. These encouraging first-in-class clinical data show UNO demonstrated evidence of immune system activation by a biomarker response in a heavily pretreated population. These data were presented at the American Society of Clinical Oncology key opinion leader event held in conjunction with the 2024 annual meeting in Chicago. In addition, Beyond Cancer presented the design of the Phase 1B trial, which will enroll up to 20 subjects with prior exposure to anti-PD-1 antibody that have either progressed, not achieved a response, or have prolonged stable disease on single-agent anti-PD-1 without radiographic evidence of continued tumor reductions. subject enrolled in the Phase 1B trial, will be treated with the UNO plus anti-PD-1 combination upon completion of the Phase 1A trial and regulatory approval. I encourage all of you to visit the Beyond Cancer website to get better educated on this potential transformational therapy for those suffering from solid tumors. Now we'll turn it over to our CFO, Doug Larson. Thanks, Steve, and good afternoon, everyone.

Our financial results for the fiscal year ended March 31st, 2024 are as follows. Revenue for the 2024 fiscal year was $1.2 million as compared with zero revenue in our previous fiscal year. We are showing a 1.3 million loss in gross margin, which is worth me spending a bit of time on. That figure is close to $2 million lower than our expectations from a year ago and probably your expectations as well. For those of you who listened in for the third quarter call, none of this will be a surprise, but it's worth repeating. There are three main drivers of this margin shortfall. First, we incurred costs related to upgrades of the LungFit devices for the last two quarters of fiscal year 2024, and we'll continue to incur costs for the next few quarters as we complete the upgrades of all devices. Second, we prebuilt several hundred devices that are currently being upgraded So we have depreciation of devices that are not currently generating revenue. Depreciation explains almost half of the margin variance. This effect disappears as we place units in hospitals and is not a drag on cash. Third, we're suboptimal in our physical warehousing infrastructure. But as we expand our customer base in each region, this effect will dissipate. Research and development expenses for the fiscal year ended March 31, 2024, were $24.4 million, compared with $16.8 million for the previous fiscal year. The increase of $7.6 million was attributed primarily to an increase in development costs, with just over half of that increase for external costs for trials and professional fees. G&A expense for the fiscal year ended March 31, 2024, was $37.3 million. compared with $34.7 million for the previous fiscal year. The biggest moving parts in the net increase of $2.7 million were due to increases in headcount. Other expense for the year ended March 31st, 2024 and March 31st, 2023 were losses of $1.3 million and $7.3 million respectively. The $6 million improvement was mainly due to the $7.1 million year-on-year decrease in non-product-related litigation, an additional $1.1 million of interest income, and $0.7 million pickup from the change in fair value of our warrant liability, partially offset by an increase in interest expense of $2.9 million. For the year ended March 31st, 2024, the company recorded a net loss of $64.3 million, of which $60.2 million, or $1.82 per share, was attributable to the shareholders of Beyond Air Inc., compared with a net loss of $59.4 million, or $1.86 a share, for the fiscal quarter ended March 31st, 2023. Net cash burden in the quarter ended March 31st, 2024, was $12.8 million. We continue to expand our pool of lung fit devices in addition to making payments on our VCAP study, continue to work on the development of our transport-ready device, human trials in Beyond Cancer, and advances in our autism program. Finally, in March we entered into a security purchase agreement with Roth Capital and Laidlaw. In that offer, we sold just over 9.6 million shares of common stock with a one-for-one callable warrant at $1.66 per share. The warrant has a $2.25 exercise price and can be called upon us achieving $4.5 million of revenues in the quarter ending March 31, 2025. We received net proceeds of $14.6 million at the end of the quarter from this purchase agreement. As of March 31, 2024, the company had cash, cash equivalents, and marketable securities of $34.5 million. As Steve mentioned in his earlier remarks, we are executing a plan to preserve capital and extend our cash runway. We'll start seeing the impact of that plan in our second fiscal quarter, which starts a week from today. Finally, as Garth mentioned in his opening remarks, given that the timeline between this call and the close of the next quarter are so close, we're not planning on hosting a Q1 conference call next month. And with that, I'll hand the call back over to Steve.

Thanks, Doug. Before we open the call up for questions, I would like to address one more item. Two weeks ago on June 7th, we filed suit in New York State Supreme Court against Airgas for breach of contract. There will be information in the 10-K that will be available shortly after this call. As this is a pending litigation, I will not be making any further comments on this matter. We will now take any questions you may have.

Thank you. We will now be conducting a question and answer session. If you'd like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. And you may press star 2 if you'd 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 keys. Our first question comes from the line of Marie Thibault with BTIG. Please proceed with your question.

Good evening. I want to start off here with a question about the fiscal fourth quarter we just completed and try to understand why we didn't see more of a sequential lift in revenue between fiscal third and fiscal fourth quarter. And as part of that, would also love to understand some of the assumptions built into the fiscal 25 outlook.

Sure. Thanks, Marie. Like we said in the prepared remarks, it was a little decision that we made to make sure that what we were upgrading got tested out with our current customers. And we wanted to make sure that everything was working well before we went out to the broader market and brought new customers in. And it's important to upgrade our existing customers. So that process took a little longer. So we didn't really get as many new customers as we had anticipated. I think that's the main reason. I wouldn't say it's the only reason, but that would be the main reason.

Okay, and some of the assumptions in the fiscal 25 outlook?

Well, we're assuming that our pipeline is accurate in terms of potential hospitals over the next nine months, and that our success rate, which we can measure fairly decently given the experience we've had in the market, that we're in a normal range of that. Not to mention, We have someone new who's going to be leading this team starting in two weeks, and we have a lot of confidence in our new chief commercial officer and the strategies that he will bring to us. So I think those are some of the assumptions. I mean, it's important that we have a database of targets and we have an expected win rate. And I think that with our machine and the shape that it's in, I think we're going to be just fine.

Okay. Given we're five, six days away from the end of your fiscal first quarter, any chance you can give us some color around how that quarter is doing, especially since we won't get to hear from you publicly next quarter?

Yeah. I mean, it's certainly better than last quarter. Our growth in this quarter will be better than our growth from 4Q over 3Q. That's for sure. Not just a little bit, but the growth rate will be significantly better.

Okay, last question from me and then I'll let others jump in. Thanks for the update on cash burn. Can you remind us on the debt financing you did a couple quarters ago, you know, the tranches that are remaining, do you still have access to the full amount? I know there were some milestones around that. Are those, is that funding still available to you?

So the milestone, the first milestone funding is not available to us. But there is another pool of money that could be available to us if we so choose to have a discussion with our lender.

Okay. And can you tell me how much that is?

Doug, what is that number? So 10 was the second tranche, 12 and a half the third tranche. 12 and a half. So the 10 is not available anymore. The 12 and a half is potentially available.

Okay. That's helpful. Thank you.

Thanks, Marie.

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

Thanks for taking the questions. My first question is that given that you guys are going to be more conservative in terms of the R&D expenses, so how should we think about, from a housekeeping perspective, the trend for fiscal 2025? both in R&D as well as in SG&A.

Thanks. I'll take that one.

So in our modeling and in the plan that Steve and I have put together, we were looking for kind of north of 15% of our operating cost reduction year on year. And we've got a plan to attain that. There's more of that in R&D, so we're looking at north of 20%. reduction in overall R&D spend year-on-year, and then in SG&A, somewhere between 5 and 10. And a little bit lower in SG&A, obviously, because our selling is in there, and we didn't want to touch that part and give David a chance to get the market running.

And also that in terms of the revenue for fiscal 2025, Should we anticipate greater portion of the revenue on the second half of this fiscal 25 versus the first?

Yes, sir.

Yeah, ramping up, as Steve was saying, you know, higher next quarter, higher growth next quarter than last quarter, and then continuing that trend through Q3-Q4.

And maybe the last question here is that the For the last quarter, the reported quarter that you indicated, was there any new accounts or mostly just the renewing of the existing accounts? And what do you anticipate at least starting in fiscal 2025? Do you anticipate more new accounts instead of, again, renewing? Or how should I see the mix? How do we see the mix, at least from your perspective? From our perspective?

Yeah, it's going to be a lot of new accounts, yeah. I mean, that's the only way we're going to increase the revenues. Our existing customers, you know, there could be a little bit of growth there if they're going to use more than anticipated, but that's marginal. You know, you don't anticipate a hospital making an estimate and then going over by 50 or 100 percent. I mean, that's extremely rare. So it's really new hospitals that are going to drive growth. So we signed new hospitals in our fiscal fourth quarter. We've signed more new hospitals in this fiscal first quarter that we're about to end than we did in our fiscal fourth quarter. And we anticipate to continue that trend, right? The growth rates quarter over quarter will get bigger. Eventually, they'll flatten out because we'll get too big in the quarter, so it will be tough to keep that going. But the number of hospitals being assigned should continue to rise over the next, you know, several quarters. If not into fiscal 26, we should see that trend continue significantly.

Okay, great. Thanks a lot. I appreciate the colors on the development. Great. Thank you.

And our next question comes from the line of Matt Kaplan with Lattenberg Salmon. Please proceed with your question.

Hey, guys. Thanks for taking questions. Steve, maybe if you can help us understand in terms of where you are with respect to the software upgrades across the existing platforms. devices?

Yeah, so Matt, we have two lines that are contract manufacturers, so we are building new systems on one and we're upgrading old systems on the other. So that process will continue for the next couple quarters. Instead of upgrading all of them on both lines, we want to make sure that we have a line making new ones from scratch as well. So, you know, the technicians over there building it don't get rusty, right? Because it's a different process when you're upgrading versus building new ones. So we have a line for each. So it will continue for the next couple of quarters.

So kind of mid-fiscal year, you'll be completed with the upgrades and then we should think about... I wouldn't say mid-fiscal year.

I would say more towards the end of the fiscal year. Remember, our fiscal year will be You know, it's nine months from the end of this fiscal year, so it's going to be at least the next two to three quarters where we're going to continue doing these upgrades, but also building new ones. So we don't anticipate any issues not being able to meet demand. If we do, that would be a high-class problem to have. And we do have the ability to crank up the new machines more. being built on our new machine line, if need be. But of course, as you know, it doesn't happen overnight. So if we do see that demand coming, we would have to make that decision, you know, three, four, five months ahead of that to ramp up. So, and, you know, you'll get a pretty good idea. It's not like we get shocked that, you know, that 17 hospitals signed in two weeks that we weren't anticipating. That doesn't happen here. So we'll get some good, you know, time to make those decisions. We can see hospitals three, six, nine months out of the pool of hospitals that we're targeting. So right now we think what we're manufacturing and retrofitting is good. And if we can place all of those systems, we'll certainly do a hell of a lot better than the 10 million for this fiscal year. But again, we're anticipating to hit that number, but we are building a little bit more than what that number would translate to. So if we were able to place all of our machines, we'd certainly be able to beat that number. So we're not in a deficit capacity in terms of supply.

Okay. And then how should we think about, and where are you focused on driving growth? Is it more kind of breadth or depth of use at existing accounts? So breadth meaning expanding customers and breadth, depth meaning, you know, use at existing customers or both?

So I think it's both, but it's new customers is going to be the real driver. I mean, you know, again, a hospital knows they're using 10,000 hours a year or 15,000 hours or 3,000 hours or 25,000 or what have you. You know, they're not going to come back to us and say, hey, you know, we're using 50% more than we thought. We love your machine. I mean, there can be some increase there. Maybe they're switching over from, you know, from Flowland, for example. They're switching over from that product to use Nitric more. But, again, it's not going to be some massive, massive move. I think that, you know, getting recommendations from existing customers from hospitals that they, you know, they work with in certain areas is really where we're starting to build the business. So I think it's the referrals that helps us the most. We just also, you know, recall that we do have a partner overseas in Asia, and we expect before the end of this calendar year to hopefully get some European partners, so there will be some shipments going out to at least Asia this fiscal year.

And then last question in terms of the TMA supplement, which is under review. I guess initially we had thought about calendar year's second half of this year. What's pushing it to the fourth quarter, and what do you think that impact will have on on their revenue ramp upon approval of the PMA for the cardiovascular indication.

Okay. It's still second half, Matt. I wish it was the third quarter until the fourth quarter of the calendar year, but it's still in the second half. And you know how FDA takes their time, and I don't think it's going to impact. I think that the guidance that we have given, even the prior guidance and the current guidance, doesn't include any impact from cardiac cardiac surgery on the label in fiscal 25. Certainly for fiscal 26, it's something that we anticipate having in the back. But again, this is the process with FDA. That's why we said second half, you know, would have been great if it was a September, October, you know, or, you know, September, October would be great. Maybe it's going to be October, November now kind of timeframe. We'll see. And there's no guarantees of that, Matt, as you know, I mean, this is just based on our most recent communications with FDA. This seems like the timing is, But, you know, there can be more questions. This is not a drug review, as you know. There's no PDUFA date, right? There's no exact date. This is on the medical device side. So, you know, it's never a hard target. It's always a moving target. And, again, based on what we know from FDA, it should be the December quarter where we get a decision. But, again, I'll update you if that changes.

Great. Thanks, Steve. Thanks, Matt.

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.

I want to thank everybody for listening in. We're pretty excited about the point that we're at right now. I wish it happened a little sooner, but sometimes you got to wait for the good stuff. All right.

Look forward to speaking to you all in the future.

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.