Beyond Air Inc (XAIR) 2023 Q1 法說會逐字稿

Good afternoon, and welcome, everyone, to the Beyond Air Financial Results Conference Call for the First Fiscal Quarter ended June 30, 2022. (Operator Instructions) Please note that today's event is being recorded.

At this time, I would like to turn the call over to Corey Davis from LifeSci Advisors. Please go ahead.

Thank you, operator. Good afternoon, everyone, and thank you for joining us. Today, after market close, we issued a press release announcing the first quarter of fiscal year 2023 operational highlights and financial results. A copy of this press release can be found on the Investor Relations page of our website.

Before we begin, I'd 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 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 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 this live broadcast, August 11, 2022. 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 today's call are Steve Lisi, Chairman and Chief Executive Officer; Duncan Fatkin, Chief Commercial Officer; and Douglas Larson, Chief Financial Officer of Beyond Air.

With that, I will now turn the call over to Steve Lisi. Steve, go ahead.

Thanks, Corey, and good afternoon to everyone joining us. On today's call, I'll begin by providing an update across our portfolio, including Beyond Cancer before turning it over to our Chief Commercial Officer, Duncan Fatkin, who will provide an update on the LungFit PH commercial launch. This will be followed by an overview of our financial results for the quarter by our Chief Financial Officer, Doug Larson, and then we will open the call up for questions.

To start, I'd like to thank the Beyond Air team as they continue to embody the mission of our organization in developing and commercializing the LungFit platform to address several therapeutic indications. This includes LungFit PH, which is our initial device to receive FDA approval. We believe this system has the potential to revolutionize the treatment of persistent pulmonary hypertension of a newborn, or PPHN, in the United States and cardiac surgeries around the world.

Our sales and marketing teams have been working hard for the 6 weeks since approval, implementing the initial phase of the commercial launch of LungFit PH. At this point, everything is as expected, and the feedback from hospitals have been very positive. We also anticipate launching internationally through a partner next year, given our current expectation of receiving CE Mark in Europe before year-end. We will provide more information on our global strategy as these matters unfold.

Turning now to our development pipeline. I will be brief since we reported our fiscal year just 6 weeks ago. We're very pleased to let you know that we will be presenting incremental data from our at-home LungFit NTM study at the American College of Chest physicians or CHEST 2022 in October. As a reminder, we presented interim data on this 12-week study that showed high concentration in inhaled nitric oxide was well tolerated following a total of 2,323 inhalations self-administered at home with no treatment-related discontinuations reported and overall high treatment compliance.

Quality-of-Life data trended strongly in favor of NO, which is what FDA's most recent guidance requires for the primary endpoint in NTM studies. If ultimately approved, we believe the LungFit GO has the potential to be a game changer for this patient population and could open the door for Beyond Air to the enormous home market for respiratory diseases. To expand the landscape for both LungFit PRO and GO, we're currently planning to initiate a pilot study in 2023 that will evaluate the LungFit GO treating severe exacerbations due to lung infections in COPD patients.

Moving on to our viral lung infection program, which uses the LungFit PRO system at 150 parts per million NO to treat community-acquired viral pneumonia in adults and bronchiolitis in children under 2 years of age. We are pleased to show more data from our viral community-acquired pneumonia study at a medical conference this fall. Our next milestone for this indication will be a discussion with the FDA over the next few months on a U.S. trial design with the intention of starting such a study in the fourth quarter of calendar 2023.

As a reminder, we have now completed an adult pneumonia study, 3 bronchiolitis studies, 2 NTM studies, along with several other studies to give us in excess of 5,000 NO administrations at 150 parts per million to 250 parts per million to over 170 patients with an excellent safety profile.

Moving to our private affiliate Beyond Cancer. We announced in late June that the Phase I clinical trial opened for screening, and we anticipate treating the first patient in the coming weeks. As a reminder, this study is designed to evaluate the maximum tolerated dose, safety and efficacy of ultra-high concentration nitric oxide injection into solid tumors in refractory setting. Beyond Cancer is also working towards presenting combination data in mice later this year. While we remain confident that there are tumors where NO may be effective as a monotherapy, we are also examining where NO maybe used in combination to treat a variety of solid tumors.

Now it's with great pleasure that I hand the call over to Duncan Fatkin, Chief Commercial Officer of Beyond Air, to speak about the first 6 weeks of the U.S. commercial launch for the FDA-approved LungFit PH. Duncan?

Thanks, Steve, and good afternoon to our investors. With FDA approval received in late June, the past 6 weeks have been a truly exciting time for the whole Beyond Air team, as we focus on our goal to fulfill the enormous potential for LungFit PH. During this time, we have been busy executing against our go-to-market strategy, which includes a multiphase commercial approach. The initial phase represents a measured release of LungFit PH to a select group of hospitals that have Level 3 or Level 4 [NICUs] and staff experienced with inhaled nitric oxide.

Our team is actively conducting demonstrations of the system to the staff of these hospitals, from which the feedback has already been overwhelmingly positive. The hospitals we have visited so far have been excited by the opportunity to eliminate cylinders and by the speed at which the LungFit PH system can generate a steady dose of nitric oxide. The hospital staff will typically comment on how simple LungFit PH is to use and are genuinely excited to evaluate the system.

As one hospital director of respiratory care mentioned, we've been waiting and waiting for you to get approved. This interest was reinforced at the NeoHeart Conference where our team exhibited last week in Los Angeles, attended by almost 1,000 delegates where we had the opportunity to engage with hospitals across the country.

As we look ahead, our focus is to sign contracts with the first wave of hospitals and make sure that everything runs smoothly. Over the first 6 to 9 months of an initial hospital engagement, our team will work closely with the hospital staff to ensure that Beyond Air has optimized our logistics, customer service and product performance, which we refer to collectively as the LungFlex 24/7 partnership and support program. There are 3 components of this program that together make up what we believe will become the gold standard to the nitric oxide industry.

First, as its name implies, we have designed the LungFlex business model to be flexible and transparent, providing an all-inclusive contract that includes the necessary number of LungFit PH systems, backup systems and accessories for the period of their contracts. This will allow hospitals to budget for their nitric oxide system with certainty.

Secondly, we have recruited a very experienced clinical specialist team that will not only provide initial training, on-site clinical expertise and support, they will also be available on demand. All members of our clinical specialist team are registered respiratory therapists and have specific experience in the nitric oxide industry.

Finally, the LungFlex service and support line will provide 24/7 access to all customers to technical, clinical and commercial support. Our team will handle everything from routine orders and billing inquiries to emergency deliveries using our rapid replacement program.

We do not expect these initial hospitals to require an abundance of devices upfront. However, they will have a sufficient volume of hours per month to provide a rigorous test for LungFit PH and the Beyond Air team. Of course, FDA approval is just the start of our commercialization journey. We anticipate the CE mark for the LungFit PH system to be granted before the end of 2022.

In addition, we are planning to submit our supplemental PMA to the FDA for an expanded cardiac label. Then in the first half of calendar year 2023, we anticipate the start of Phase II of our launch. We'll be expanding our commercial team to support this much broader sales efforts and would expect this to lead to an acceleration in our commercial success.

I will now turn the call over to Douglas Larson, our Chief Financial Officer, to provide an overview of our financial results for the fiscal quarter ended June 30, 2022.

Thanks, Duncan, and good afternoon to our investors. Our financial results for the first quarter of fiscal year 2023, which ended on June 30, 2022, are as follows. On a GAAP basis, research and development expenses for the fiscal quarter ended June 30, 2022, were $3.2 million compared with $2.7 million for the fiscal quarter ended June 30, 2021.

On a GAAP basis, general and administrative expenses for the fiscal quarter ended June 30, 2022, increased to $8.2 million compared with $3.9 million for the fiscal quarter ended June 30, 2021. This is mostly attributable to the staffing and scaling up of Beyond Cancer in both the U.S. and Israel as well as the continuous investments necessary to support the commercial launch of LungFit PH in the U.S.

Other income and expense for the fiscal quarter ended June 30, 2022, was a loss of $0.2 million, comparable with a loss of $0.2 million for the fiscal quarter ended June 30, 2021. For the fiscal quarter ended June 30, 2022, the company had a GAAP net loss of $11.7 million, of which $10.9 million or $0.37 per share was attributable to the shareholders of Beyond Air, Inc. compared with a loss of $6.7 million or $0.31 per share for the fiscal quarter ended June 30, 2021.

Net cash used in operating activities, including those of Beyond Cancer, was $6.8 million during the quarter ended June 30, 2022. As of June 30, 2022, the company reported cash and cash equivalents of $72.8 million. We still expect our average quarterly cash burn for fiscal 2023 to be within a range of $8 million to $10 million.

As such, we believe our current cash and cash equivalents are sufficient to fund operations well beyond the next 12 months, including through the initial commercial launch phase of LungFit PH in the U.S. We expect to start showing revenue in our third fiscal quarter. In addition, we expect to report low or even negative gross margins for the next 2 quarters as we start to incur some supply chain expenses, which will be classified as cost of goods sold.

With that, I'll hand the call back to Steve.

Thanks, Doug. Operator, let's go to Q&A.

(Operator Instructions) Today's first question comes from Greg Fraser with Truist.

I was hoping you could talk a bit more about the feedback that you've been getting from the hospitals. Curious what attributes to the system resonate the most -- you mentioned speed as one. Is there anything else that you would point out? And has anything come up in the discussions that has been unexpected?

Duncan here. Thanks for the question. Yes, certainly, people are very impressed with how quickly it produces nitric oxide. I think there's the obvious reaction to the elimination of the bulk of the cylinders and the logistics associated with that, but also just the simplicity, it's very easy-to-understand system and their expectation is that the training process isn't going to be at all onerous and transition would be quite straightforward. So I think that what's happened with the demonstrations is they typically don't last too long because it's such a straightforward system to use.

And then the question is all about how they can integrate that into the hospital and the whole process of actually reaching some kind of agreement. So we're getting the kind of feedback we expected to about the speed and the simplicity is really the other component that we're getting great feedback about. And then they're obviously intrigued at the system's ability to generate nitric oxide from room air and the predictability of the system as well is something that they're excited about.

Great. Can you comment on if there are any notable differences in the LungFlex program versus (inaudible) total care program?

Well, the way that we're approaching it, certainly from a general perspective, there are very much similarities. But in terms of the response, we're aiming to be very flexible and transparent with our business model. Sorry, can you hear me okay?

Yes.

So I'm not sure how much of that you heard. I think we had an interruption, but I'll repeat just in case.

I heard it all.

Okay. So the business model, we're certainly aiming to be very flexible and transparent. And depending on the hospital, that may be a significant difference in terms of their ability to use the system beyond what they might be currently using it because they have potentially got protocols in place to limit the use of nitric oxide because either the cost or the flexibility that our system might offer. In terms of the locations of our systems, we're going to have a network of stocking locations that won't be particularly different. And the team that we've recruited, some of which have an incredible amount of nitric oxide experience, we expect to be able to offer at least strong clinical backup.

So I'd say it's the flexibility and transparency of the business model. That's going to be the most obvious difference initially. And then over time, we're hoping that they'll also see some other benefits that I'm not going to go into because we have some unique capabilities that we've built into our logistical partner.

Got it. Very helpful. Just one more if I can, if I may. Is the potential for cost savings tied to not having to deal with cylinders? Is that something that comes up in the discussion and is it something that just the hospitals are focused on, logistic clearly would be an advantage not having to transport, et cetera. But are there cost savings attached to that also that are important to hospitals?

Yes. I think that it clearly varies from hospital to hospital, depends on how they're set up. So I wouldn't want to assume that it's the same for every hospital. However, generally, there's a couple of reactions to the ease of use, the elimination of logistics and the workflow, which can have direct cost savings, but also as significant they can make it just easier to use the system, allow the clinicians to focus more on the patient welfare.

And also when they're using the system, there's a predictability that is built into our system, so no matter what type of treatment that they are providing. And this is associated with the dose that they're providing and the ventilator use setting that they have. The time that the filter time for us is 12 hours no matter how the system is being used, no matter what the dose of flow is.

So that kind of predictability and ease of use allows them to plan much more effectively and potentially avoid overrun charges that exist with cylinders or just general use of additional cylinders, which we know is for sure happening. So we've stated before, we don't intend to compete aggressively on price rather on value. And as I said, that, of course, depends on hospital -- from hospital to hospital.

The next question comes from Scott Henry with ROTH Capital.

Just a couple of questions. First, the G&A of $8.2 million, you talked about what went into it. The question is, is that a good go-forward number? Should we think about that? I mean I imagine there'll be some additional selling expenses as we go. But how representative is the $8.2 million going forward?

Scott, it's Steve here. I think it's fairly representative. And you're right, as we get into the first half of next calendar year, it will probably start to move as we begin our second phase of the launch. But you'll see in the Q that goes up probably in the next 20, 30 minutes that there's a little bit of noncash items in there as well.

Okay. Great. Thank you for the color. And then another question, the Cardiac Label. Can you talk about how the addition of a Cardiac Label impacts your product, particularly how it is positioned to the other players in the market?

So right now the cardiac usage for nitric oxide is off-label. So hospitals that use it are not getting reimbursed and it's certainly hurting the profitability on those surgeries that where they need to use nitric. So getting it on label, obviously, allows us to target those physicians and hospitals where it's being used and give them the reimbursement that that comes along with the label. So I think that's a very important piece of the equation for us. Right now no one else has that on label.

I'm not saying others may not be pursuing it. I don't know. But I think it's going to be very helpful for us and for everyone in the market actually. So I think eventually, if one of us gets it, I think, over time, everyone will get that on label. But it'd be nice to be first. We want to get that on label. That's for sure. It should be very helpful. But I think the hospitals would gladly accept reimbursement for the use of nitric if they can get it.

Okay. Great. Steve, what's the latest estimate of what percentage of the market is cardiac usage?

I think it's well more than half of the market, cardiac usage. So you do have new born babies, PPHN babies. You certainly have a component of acute respiratory distress syndrome there in COVID-19 as well that is being used for. So -- but I would say that cardiac is more than all those other conditions combined for sure.

Okay. Great. And then a final question, and I don't know if you've given this, but the initial phase of launch, which we're in right now, have you talked about how many centers you are targeting? Were there a specific number or a range of hospitals? How should we think about the scope of the initial phase?

So I'll take that, Scott. Thanks for the question. So I think we've been pretty consistent on this. We're aiming for about a dozen hospitals in that first 6 to 9-month period. It may change depending on whether a couple of hospitals are connected to each other and they want to work in tandem, et cetera. But that's been the focus because we want to use that time to optimize logistics service and make sure that everything is working as planned.

The next question comes from Matt Kaplan with Ladenburg Thalmann.

I guess just a quick follow-up to Scott's question. If you're targeting 12 hospitals, how many devices do you hope to place in those 12 hospitals? Should we think of it as kind of one system for a hospital or is there chances for multiple systems?

Matt, you're probably looking in anywhere from the mid-single digits into the teens. It just depends on the hospital and where we're looking. And there are plenty of hospitals that have 25-plus units that they use in the beginning of our launch here. I don't think we're going to be committing 25, 30 units to one single hospital and that's just during the first 6 to 9 months. So I don't think we're going to be going to hospitals where they're using 1 or 2 systems. We need to use -- we've said before, we're targeting hospitals that have a certain volume of hours per year so that our machines can get used, and we can get feedback on how they're performing.

Okay. And then just going back to the business model in terms of revenue generating, how should we think about this -- the devices, device component and perhaps the filter component as the revenue generating component for your business model?

So the way the market works now essentially is the hospitals are charged per hour of usage of nitric. So all of these other components for our competitors, delivery system, cylinder and all the connections and so forth, they're not really itemized for pricing. They're included in the package of what they pay per hour for nitric. So we're going to try to keep things status quo with how things are done contractually and what they're charged for.

So you can look at us as charging on an hourly basis, just like our competitors do, kind of throw in everything else in essentially for argument's sake. And the way we'll be able to track that is our filters last 12 hours and no matter what the situation is, no matter what the concentration of NO is or the flow or the type of event being used in the last 12 hours. So it's very easy for us to track the time that the hospital has used our system for.

Okay. And then last question, in terms of your inventory of devices, can you talk a little bit about that and kind of any constraints that you see in terms of being able to supply devices to the hospitals, the first 12 hospitals in the initial stage of launch?

I don't think we're concerned about the initial stage. I think we're good there. And we're looking out 9 months plus to supply what the demand will be at that moment in time. And we face the same challenges that everybody else in the world faces with electronics and supply. So we're no different when we get to Phase II from everybody else out there. Phase I, we're good, recovered.

Okay.

So we have talked to gather more components and build more systems.

Great. And then just 2 quick questions, and I'll jump back in the queue. On the pipeline, you said you only have updated data on the LungFit GO NTM at CHEST in October. What should we expect to see there in terms of numbers of patients and type of data that you're going to have there?

You're going to see 15 patients, and we'll have to see what the data are going to be. I actually don't know, Matt, because my statistician won't tell me. He says, what I'm done, you'll know. So that's it. I don't bother him.

Okay. Fair enough. And then last question in terms of the Phase I study for your oncology program, you open street in June. You said you're going to enroll first patients this quarter. Where -- can you give us a sense in terms of where the centers are? And is this a worldwide study? One country only?

Israel.

Israel.

Israel. It's a Phase I first in human. So it's just -- we don't need -- no way it's multi-country, it's just Israel.

And do you expect to have an IND open in the U.S. in the near term or...

It depends what you mean by near term. But yes, we're going to have it. I'm going to get one of those in the U.S. at some point, yes, absolutely.

The next question comes from I-Eh Jen with Laidlaw & Company.

Just one quick one, how do you assess that the Phase I is mature enough to enter into the Phase II commercialization simply just by the time doesn't hospitals or any other metrics to make assessment?

Yes. Thanks for the question, I-Eh. I think that initially, we're taking the view that we need that time, the 6 to 9 months to fully evaluate and allow any sort of adjustments to be made. If we really don't see those kind of obstacles and things are going really well, we will aim to try and accelerate. So there's no specific milestone. It's more us making sure that we allow enough time to be prepared for anything and deal with anything that comes our way. And we're hopeful that we'll be able to get a going certainly at that point into the Phase II or a little bit earlier. It just depends on how that initial work goes.

The next question comes from Suraj Kalia with Oppenheimer.

Okay. So Steve, Duncan, for either one of you. The high level NICUs that you are talking about, the 9% to 12% for PPHN, how should we envision the construct of a typical contract, exclusive, non-exclusive, volume-based, registry-based data minimums? Just kind of give us some additional parameters that you could?

Look, it's -- again, it's fairly standard out there, the way the contracts are made by our competitors. So we're going to be pretty consistent with them and it's based on an hourly rate and an estimate of how many hours we use per year. And we're going to do the same thing as hospitals know what they're doing for the past 22 years of using nitric. So we're going to work with them and stick with the same system that's out there.

So it's really not much variability of what is existing at the current time. I think that would probably be something that would confuse them and be another barrier to them using us. So we're trying to make it as simple as possible. So it's not something that we're going to change or adjust if that makes sense to you.

Okay. And Steve, one of the question, in terms of Beyond Cancer, so injected nitric oxide into solid tumors, can you give us some additional color in terms of how we should think about the delivery mechanism, the residence time, diffusion? Any -- what all data at the other end from Beyond Cancer should we start leaning or looking out for that would help us better understand what has been theorized for long, but you guys could put it to practice more so from a PK profile, just how the thing is going to work?

Sure. So this is a local administration. There won't be any PK profile, and we don't enter the bloodstream. So that's one part of -- answers one part of your question. We've put out our data, and you can see it on the Beyond Cancer website that we've dosed for a duration of 5 minutes intra-tumorally. It's fairly a simple system at this point because we're doing, let's say, exposed tumor, skin surface, near skin surface tumors. So it's just a simple catheter with a needle to be able to deliver it.

So I'm not going to give any more detail on that because there is a certain amount of proprietary information about exactly how we do -- and we do have a proprietary system to deliver inside the body, but we're going to reserve that for either Phase Ib or probably Phase II studies. In the current study that we're in, we're just using the current system, and we're targeting skin and near skin surface tumors.

So what people need to look for -- and again, this is -- if you look in the Beyond Cancer website, you'll see we show what we believe to be a description of the mechanism of action and what happens in the body. So what we'll be looking for in this first in human study is obviously safety, first and foremost. But hopefully, we'll be able to see some biomarkers that will give us an idea of the immune system being armed against this tumor type, which is what we saw in the mice and we're looking for activity in T cells and B cells and many other areas of the body. So it's something that everyone should look for.

Hopefully, we'll see some activity in humans like we've seen in the mice. And when we get that data, obviously, we just opened the study. So hopefully, in the next 6 months, we'll get a bunch of patients in, and we'll be able to let people know what the data look like. And in the meantime, we hope to show some more data in animals, and we should have some combination studies that we're working on now. Hopefully, we can present them before the end of the year at a medical conference if we have that opportunity. So that might give us a little bit more information as to what that mechanism is and how it works in combination with other therapies.

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

I just want to thank everybody for joining today, and we'll talk to you next time.

The conference has now concluded. Thank you for attending today's presentation, and you may now disconnect.