Beyond Air, Inc. (NASDAQ:XAIR) has reported a significant revenue increase of over 60% in the fiscal third quarter of 2024, driven by heightened demand for product evaluations and an enhanced system rollout. The company's recent financial results showed a revenue of $0.4M for the quarter, with a net loss of $17.1M. Despite the loss, Beyond Air is optimistic about its future, citing three multi-year contracts and expectations of substantial revenue growth in the upcoming months. A pending FDA decision on the company's PMA supplement for cardiac surgery and an anticipated CE Mark approval in Europe are key milestones that could further bolster the company's financial position.
Key Takeaways
- Beyond Air's fiscal third-quarter revenue grew over 60% due to increased demand and system upgrades.
- The company expects significant revenue growth following three multi-year contracts.
- A PMA supplement for cardiac surgery label expansion is under FDA review, with a decision expected by year-end.
- CE Mark approval in Europe is anticipated in the first half of 2024, promising a milestone payment from Getz Healthcare.
- Beyond Air's pipeline includes studies in solid tumors, viral pneumonia, and autism, with COPD and bronchiolitis programs on hold.
- The company ended the quarter with $31.4M in cash and marketable securities, after raising $5.5M to offset cash burn.
Company Outlook
- Beyond Air is confident in reaching its revenue guidance of $12M to $16M in 2025.
- The company plans to expand its field team to cater to increasing system interest.
- International expansion efforts are expected to impact fiscal years 2026 and 2027, particularly in Europe and APAC markets.
Bearish Highlights
- The company recorded a net loss of $17.1M for the quarter.
- Programs for COPD and bronchiolitis are currently paused.
Bullish Highlights
- Hospital orders are growing, and the increase is not attributed to seasonality or stockpiling.
- The company has started engaging with two hospitals in February and anticipates multiple hospital starts each month.
- Beyond Air's pipeline strategy focuses on VCAP, cancer, and autism programs.
Misses
- Net loss increased compared to the $12.7M loss in the same quarter of the previous year.
Q&A Highlights
- The company clarified that another company's failure in a similar indication does not affect Beyond Air's strategy.
- Beyond Air's LungFit PH device received a software update for improved sensor accuracy and compatibility.
- The VCAP study will be extended over two seasons, giving the team more time for thorough research.
Beyond Air's fiscal third-quarter performance indicates a company in transition, with significant investments in product development and market expansion that are expected to yield results in the near to mid-term future. The company's management remains focused on advancing its pipeline and securing regulatory approvals that could unlock new market opportunities. As Beyond Air prepares for discussions with the FDA and anticipates CE Mark approval, investors and stakeholders are closely watching these developments, which could be pivotal for the company's growth trajectory.
InvestingPro Insights
Beyond Air, Inc. (XAIR) has shown a remarkable revenue uptick in its fiscal third quarter of 2024, yet the company's financial health and market performance present a mixed picture according to the latest InvestingPro data and tips.
InvestingPro Data reveals a market capitalization of $76.56 million, with a negative P/E ratio of -1.01, reflecting the company's current lack of profitability. The gross profit margin stands at a concerning -272.82% for the last twelve months as of Q2 2024, underscoring the challenges Beyond Air faces in converting revenues to profits.
InvestingPro Tips highlight that while Beyond Air holds more cash than debt, which is a positive sign for liquidity, the company is rapidly depleting its cash reserves. This cash burn could be a point of concern for investors, especially considering that analysts do not expect the company to be profitable this year. Moreover, the stock has experienced significant volatility, often moving inversely to the market, and is trading at a high revenue valuation multiple.
However, it's not all bearish for Beyond Air. The company has seen a substantial return over the last week and month, with price total returns of 18.13% and 30.3% respectively. This momentum could be indicative of investor optimism surrounding the company's future prospects, such as the pending FDA decision and potential CE Mark approval in Europe.
For readers looking to delve deeper into Beyond Air's financials and market performance, there are an additional 10 InvestingPro Tips available, which can provide further insights into the company's operational and financial nuances. Interested readers can unlock these insights and more with an exclusive offer: use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription at InvestingPro.
Full transcript - AIT Therapeutics (XAIR) Q3 2024:
Operator: Good afternoon, and welcome, everyone, to the Beyond Air Financial Results Call for the Fiscal Quarter ended December 31, 2023. At this time, participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. And now, I'd like to turn the call over to Corey Davis, LifeSci Advisors. Please go ahead.
Corey Davis: Thank you, operator. Good afternoon, everyone, and thank you for joining us. Today, after the market close, we issued a press release announcing the fiscal third quarter 2024 operational highlights and financial results. A copy of this press release can be found on our website, www.beyondair.net under the News & 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 Litigation Reform Act of 1995. Beyond Air cautions that these forward-looking statements are subject to risks and uncertainties, 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 the 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, 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, February 12, 2024. Beyond Air undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call. Joining me today on the call are Steve Lisi, Chairman and Chief Executive Officer; and Douglas Larson, Chief Financial Officer. With that, I'll turn it over to Steve Lisi. Go ahead, Steve.
Steve Lisi: Thanks, Corey, and good afternoon to everyone joining us today. Today, we announced a strong step in the right direction with a greater than 60% increase in revenue this quarter versus last quarter. While this is a small number in absolute terms, there are several factors that give us confidence in hitting our fiscal year 2025 revenue guidance of $12 million to $16 million. Filters shipped in fiscal 3Q grew by more than 100% compared with shipments in fiscal 2Q. It's important to note that this growth does not yet reflect the software upgrade received from the FDA in September as it takes time for such a manufacturing change to result in upgraded systems. Our first new hospital start with the updated system was on February 1. As this rollout of the new machines has just begun, the financial impact in the March quarter will be a bit muted as compared with the levels of revenue we expect to see in the June quarter. It is important to understand that we will maintain a balance for the next several months between upgrading our existing customer base and adding new customers. The increase in demand for product evaluations has surged since our upgraded system was displayed at the American Academy of Respiratory Care in early November. Since the conference, we have completed, started or definitively scheduled as many evaluations as we have completed in the previous 10 months. Prior to the upgraded system, we had zero multiyear contracts. I am pleased to announce today that we now have three such engagements with more multi-year requests than single-year requests by a wide margin. For reference, upgrading our software removes all compatibility issues, reduces the system noise, improves alarms and improves sensor accuracy. We have told every hospital that we welcome a head-to-head comparison with any competitor in their hospital. However, not surprisingly, we have had very few instances where a competitor was willing to sit in the same room with us at a hospital to cycle through multiple use cases with our system and their system. While still in its early stages, we have also been pleased with the progress made since securing our innovative technology contract award from Vizient, the nation's largest provider-driven healthcare performance improvement company. We're excited by this opportunity to expand our reach through the Vizient customer network. We also anticipate adding LungFit PH to more group purchasing organization platforms over the course of the next year. To capitalize on this positive growth trajectory, we will continue to build out a field team based on the growth opportunities as they evolve. One last point to make on the U.S. nitric oxide market. Our PMA supplement for the expansion of our label to include cardiac surgery was accepted and is under substantive review by the FDA. Our clinical and regulatory team is to be commended for putting together a strong submission. While there is no firm date for FDA to complete their review, we would expect a decision before the end of calendar 2024. Once approval is received, we anticipate an impact on revenue growth after a few months. Looking outside of the United States, we still expect to receive CE Mark in the first half of calendar year 2024. 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 LungFit PH in several countries in the Asia Pacific region, excluding Japan. Moving on to our pipeline. During the quarter, Beyond Cancer announced that its Phase 1 study evaluating ultra-high concentration nitric oxide, or UNO, in advanced relapsed or refractory unresectable primary or metastatic cutaneous and subcutaneous solid tumors has cleared the first cohort of 25,000 parts per million single-dose UNO by the Safety Review Committee with no reported dose-limiting toxicities. This means that there is an UNO dose of 25,000 parts per million nitric oxide that is safe for human use. And given the data shown in November at the SITC conference, there should be confidence there is an immune response much like we saw in preclinical studies. As a reminder, this is a first-in-human study that is being conducted in two parts, dose escalation and dose expansion. The dose escalation part will consist of three UNO dose cohorts, 25,000, 50,000 and 100,000 parts per million nitric oxide, or possibly a concentration below 25,000 parts per million. The dose expansion portion of the study will begin once the recommended dose is determined with the primary objective of the trial to assess safety and tolerability of UNO with a secondary objective of assessment of efficacy by immune biomarker response to UNO therapy. One last note is that we anticipate completing the Phase 1a study and presenting the data in the first half of this calendar year and then initiating a Phase 1b study in the back half of the calendar year, which will include combination therapy with anti-PD-1 therapy, given the strong combination data shown to-date in the preclinical setting. I encourage all of you to visit Beyond Cancer website to get better educated on this potential transformational therapy for those suffering from solid tumors. Our viral community-acquired pneumonia, or VCAP, study is underway. As a reminder, this randomized, double-blind, placebo-controlled pilot study will treat hospitalized patients with 150 parts per million nitric oxide intermittently for up to seven days. Due to viral pneumonia following seasonal patterns of activity, this is a seasonal study running through the fall and winter months. As a result, we have decided to conduct this study over two seasons. Thus, we expect to announce top line data by the middle of calendar year 2025, with interim data updates when appropriate. This will not change the timing for a pivotal study in the '25-'26 season. Obviously, viral pneumonia is a significant unmet medical need given the times we live in. Turning to our autism program. We are pleased that the program remains on track for human data in 2025. Please recall that this early stage development program is being conducted in partnership with The Hebrew University of Jerusalem, which continued to produce exciting preclinical data. As a reminder, the data thus far have shown that reducing nitric oxide production by inhibiting neuronal nitric oxide synthase, reduces nitrosative stress biomarkers in the brain and reverses the molecular, synaptic and behavioral autism spectrum disorder associated phenotypes. To be clear, a reversal of behaviors associated with autism was demonstrated in several different genetic mouse models of autism. We believe this program offers tremendous potential and look forward to providing updates as we progress throughout the year. Now, I will turn it over to our CFO, Doug Larson. Doug?
Douglas Larson: Thanks, Steve, and good afternoon, everyone. Our financial results for the fiscal quarter ended December 31, 2023, are as follows: Revenue for the fiscal quarter was $0.4 million as compared with $0.2 million for the previous quarter and $0 for the fiscal quarter ended December 31, 2022. While we are seeing positive operating margins on our individual contracts, there are three reasons why our overall gross margin remains negative. First, we incurred costs related to the software upgrade of the LungFit devices. Note, there will be similar costs for the next two quarters as we complete the upgrade of all of our devices. Second, because we prebuilt several hundred devices that are currently being upgraded, we have depreciation of devices that are not currently generating revenue. Third, consistent with this early stage of growth, we are suboptimal in our physical warehousing infrastructure, but as we grow this effect will dissipate. Our supply chain is committed to being a great partner to the hospitals we engage with and having the right number of high-quality upgraded systems in the right location is key. Research and development expenses for the fiscal quarter were $6.8 million, compared with $5 million for the fiscal quarter ended December 31, 2022. Of the $1.8 million incremental spend, $1.2 million was due to development costs associated with our pipeline, mainly from the start of our VCAP study. Investment continued to ramp up in Beyond Cancer, but this was mostly offset by favorable comps in NTM and autism. The remaining $0.6 million was almost exclusively due to loaded salaries in Beyond Air's R&D teams. SG&A expenses for the fiscal quarter were $9.8 million compared with $8.9 million for the fiscal quarter ended December 31, 2022. The $0.8 million increase was mainly due to stock-based compensation and salaries with the majority being noncash compensation. Other income and expense for the fiscal quarter showed a $0.2 million loss compared with a $0.2 million gain for the fiscal quarter ended December 31, 2022. There's a lot of moving parts again this quarter, but the biggest movers are an increase in interest expense of $0.8 million, being partially offset by a $0.4 million increase from gains in our marketable securities. For the fiscal quarter ended December 31, 2023, on a GAAP basis, the company recorded a net loss of $17.1 million, of which $16.1 million or $0.50 per share was attributable to the shareholders of Beyond Air, Inc. compared with a net loss of $12.7 million or $0.43 a share for the fiscal quarter ended December 31, 2022. Net cash used in the quarter ended December 31, 2023 was $12.7 million. We alluded to a higher cash burn this quarter in our last call, with payments required towards our VCAP study, development of our Gen 2 device, continued in-human trials in Beyond Cancer and advances in our autism program. We also raised $5.5 million on our ATM in the quarter to partially compensate the planned cash burn. As of December 31, 2023, the company had cash, cash equivalents and marketable securities of $31.4 million. And as a reminder, we also have $5.2 million held on deposit by our contract manufacturer. And with that, I'll hand the call back to Steve.
Steve Lisi: Thanks, Doug. We will now take any questions you may have.
Operator: Thank you. [Operator Instructions] Our first question comes from the line of Jason Bednar with Piper Sandler. Please proceed with your question.
Jason Bednar: Hey, good afternoon. Thanks for taking the questions here, guys. If I could just start maybe on some of the recent developments, clearly, some more steps forward on the contracting front, some wins you mentioned there, that's all good. When I step back and think about where we're at in the context of your $12 million to $16 million revenue guidance for next year, you're clearly signaling confidence about future contracting as well. So, I guess, when I back that up and needing a good jumping off point to exit this year in order to move into that $12 million to $16 million range, and also consider January tends to be, I think, a good contracting period or at least a lot of discussions happening here at the new year, can you talk about maybe the commercial signals you've seen here early in calendar '24?
Steve Lisi: Sure. Thanks, Jason. Appreciate the question. Like we mentioned in some of the prepared remarks, seeing customers asking for longer-term contracts with us, locking us in, which is very good. We're very happy to do so. They want to contract for the long term with us. That's confidence in our system, especially with the upgraded software. We're seeing, as I said earlier in the prepared remarks, a massive increase for us in requests for evaluating our system. So, we are scheduled consistently over the next six to eight weeks, and we're scheduling more beyond that. So, the interest is certainly there. Again, we are attending to our existing customers as well as entertaining new customers in parallel now and for the next couple of months. Our existing customer base is very important to us. They've helped us understand how to optimize our system and they've been working with the system prior to the software update. So, we appreciate that. And we're going to take care of them as well as bring in some new customers as well. So, once they're taken care of and we can focus our efforts 100% on new customers, that will be very exciting for us as a team. This is not just a Jan 1 start for hospitals. You mentioned that's certainly a busy time at Jan 1, beginning of the year. But there are other points in the year where there's lots of contracts starting up, July 1 being probably the biggest along with Jan 1. So, there's a lot going on. There are starts, we just -- like I mentioned earlier, we have a start on Feb 1. There're hospitals starting mid-month. There're hospitals starting on the 1st of every month. So, it's just a matter of us having the supply available and making sure that our existing customers are taken care of. So, we see what's coming. We're very excited about it. We'll be adding people to the team to be able to handle what's coming in the next three to six months. So that's all I can say. I mean, I don't know what else you'd want, what are the metrics you need, but if you need some more metrics, just go ahead and ask.
Jason Bednar: No, that's super helpful. I'm just trying to get more anecdotal and qualitative to get a sense, and it sounds like things are moving in the right direction for sure. Maybe I'll use your personnel reference there to segue to the next question is more -- just any more color you can give around Duncan's departure? Just maybe how quickly you're looking to backfill this spot? You're, obviously, at a critical inflection point commercially. I just want to make sure there's, call it, a seamless and quick transition here.
Steve Lisi: Yeah. I think that the transition will be seamless. I don't know when we'll have someone new in that role starting up. But we have a pretty strong team here internally. So, we're certainly working together as a team to bring these things forward. I wish Duncan the best and he's done a great job for us. But we're focused on the task at hand. And I think we have the right people at the company right now. And obviously, we need to add as we grow as opportunities come our way. But we're going to wait for the right person, bringing in the wrong person because we need someone quickly is not the right attitude. So, I think that with what we have in place, we certainly can wait for the right person to come our way, whether that be in 30 days, 60 days or 180 days, I can't tell you that right now, I don't know. But I want the right person in that role.
Jason Bednar: Okay. All right. Makes sense. And then, one last one. Doug, I appreciate the help on some of the gross margin moving parts. I know it's super early days here, but just trying to get a sense if -- is there a way to quantify or strip out what some of those one-time costs would have been? It sounds like they were elevated here in the second quarter -- sorry, your fiscal third quarter and -- but they're going to be there for the next two quarters. Just trying to get a sense as we model this out appropriately, what maybe an adjusted gross margin would have looked like or adjusted cost of goods sold would have looked like for you in the quarter?
Douglas Larson: Yeah. Thanks, Jason. I am a little hesitant to break out the pieces. But between the depreciation on machines that aren't deployed and refits for the devices that we were upgrading the software on, we're talking somewhere between $400,000 and $500,000 in the quarter. So that -- I hope that gives you kind of an idea of -- I think that will recur next quarter again. And then, as the sales pick up and we are done upgrading all the devices, those numbers are going to disappear. And then, as we get more revenue, obviously, those -- that depreciation just becomes a normal part of our cost of sales.
Jason Bednar: All right. Perfect. All right, thanks so much.
Operator: Our next question comes from the line of Les Sulewski with Truist. Please proceed with your question.
Les Sulewski: Good evening. Thanks for taking my questions. Steve, just on the environment in the hospital setting, can you just true up how the pricing environment is driving the decisions among the hospital groups that you are engaging? And then, I guess, second part to that, give a little bit more color, if you could, around the sizing of the new -- of the three new engagements you've mentioned? And what would be your expectations on the conversion rate on that?
Steve Lisi: Let me start with that. What do you mean by conversion rate on that?
Les Sulewski: Conversion of contract...
Steve Lisi: The three new engagement we mentioned -- so, we have those contracts. Those are inked. Those are just multi-year deals.
Les Sulewski: Got it. okay.
Steve Lisi: Those are already done there.
Les Sulewski: Can you give a little more color on the sizing of that, if that's possible?
Steve Lisi: I would say that two of them are probably slightly below market average, and one of them is probably double what you consider market average. So, these are -- they're good-sized contracts. I really want to give too much detail on it, but these are good-sized hospitals. They're doing pretty good volume, even the two ones that I would consider to be a little bit below what the average-sized hospital would be, do pretty good volume. But the other one is a lot of volume. I mean, there's patients, a lot of patients on every single day. I mean, we've got over 20 machines in that hospital. It's a big hospital. So I hope that helps.
Les Sulewski: It does.
Steve Lisi: So, let me go back to your price question. It's -- price certainly plays a role. There's no doubt about it. I think that's true in any situation, the hospital wants to get the best price that they can, but that's not the only thing that plays into a decision for the hospital, but it certainly plays a role. I mean, we can't be naive to that fact. And I think that -- I've said this before, I think that the pricing environment is not too far off from what we expected when we entered this market. It's pretty much within the range that we anticipated. Some hospitals will get better pricing than others based on certain factors, volume being probably the biggest factor. But I don't think it's the only factor, and I don't want to give you the impression that this is a race to the bottom in this market for price, it's just not true. I think it's a healthy pricing environment.
Les Sulewski: Got it. Very helpful. On the VCAP study, can you just give a little bit more color how this was extended into two seasons? And then separately, on the one-fold increase on your filter shipments, can you translate that into utilization, or is this a seasonal inventory stocking? Just give a little more commentary on that, if you could.
Steve Lisi: Yeah, there's no seasonal inventory stocking here for this stuff. That's just the growth. I mean that's just -- the numbers are what the numbers are. There's nothing -- no seasonality about it. There's no stocking up. I mean these hospitals, normally, they're ordering what they need for the next -- it depends on the hospital next 30, 60, 90 days, I mean, it's really individual hospitals will have different needs, but they don't need to stock up a year of supply of this stuff. This is not how it works. So, it's just a true growth. So, on the VCAP study, I mean, look, this is safety study. If you're doing efficacy, it needs to be in one season, safety doesn't necessarily need to be in one season. Given that we won't change our date for our pivotal study, to take a little pressure off of my team, we got the approval late in the June quarter last year. It was tight to get all the sites up and running on time for the season. So, we made a decision around Thanksgiving that we would extend this over two seasons. It was always something that was in our back pocket, just in case, but we just couldn't get all the sites up and running as quickly as needed. And rather than try to spread ourselves then, we decided to focus on a couple of core centers, and we'll spread it out. I think it's the best way to go, trying to get it done in one season, given the short time frame. We gave it a shot. I don't think we didn't, but you had to make a decision before we really got into the swing of the season on that, and that's what we did. So, it was always something we considered internally. Again, as long as it doesn't push out our pivotal study start, I don't think it's a problem at all. I think it's actually the right thing to do given the situation.
Les Sulewski: Got it. That's helpful. Maybe from a high level, could you kind of quantify the pecking order, your pipeline strategy, anything that could be pushed back further if there's risks involved, whether it's financial or time? Any kind of color around the high-level strategy process and thoughts around the pipeline?
Steve Lisi: I mean I think we're pretty much showing everybody what we're doing. I mean VCAP, cancer, autism are the ones that we are working on right now. Again, autism is relatively inexpensive compared to the other two programs, obviously. I mean it's preclinical. It's not costing us a lot. And I think once getting it to first in humans for that one in '25 and getting some data, I mean, that's not a high cost. I mean, when we start to go into maybe Phase 1b or Phase 2a for that program, that's when the cost will really kick in. But until then, it's not overly expensive. NTM is our next program up. I think we'll be meeting with FDA before the end of this year, calendar year that is, to get some ideas from them and work with them on a trial design. Hopefully, that will be a pivotal trial design. That's our goal. COPD, obviously, has not been moving forward. That's evident in our corporate presentation. So that's the one that's kind of just sitting there on hold at the moment. Bronchiolitis also on hold. I think that's been clear for the last couple of years. So, I think it's very clear what our priorities are in the pipeline and where they are. So, I don't know if there's -- I don't know if I answered your question, but I think I gave the rank there.
Les Sulewski: No, that's helpful. Thank you for that, Steve. Appreciate it.
Steve Lisi: Sure, yeah.
Operator: Our next question comes from the line of Yale Jen with Laidlaw & Company. Please proceed with your question.
Yale Jen: Good afternoon, and Steven, thanks for taking the questions. Maybe to start on the LungFit PH. Have you guys actually reported what the total number of hospital has been using the -- including the three multi-contract ones that to be used or already using the device?
Steve Lisi: Yeah. We haven't said how many hospitals are out there. We don't want to give any information out to the general public about how many hospitals we're in or where they are or who they are. So, we're not going to comment on that. But...
Yale Jen: Okay. That's fine. That's good. Maybe just a little bit more color in terms of the software update in terms of the specific general aspect of the updates, which makes the -- make a significant difference compared to the previous -- earlier one.
Steve Lisi: Yeah. So, just to little tiny background. Remember, we froze the design of our system in early 2019. So then we had this lovely global pandemic. So, it took a while to extended the time to submission, extended time to approval. So, there's a lot of things that three-and-a-half years of this -- of no changes in our system where the rest of the world is having changes makes it difficult for us to catch up right away. So essentially, this software update gave us optimal accuracy with our sensors for monitoring and our delivery. It gave us compatibility with all the systems out there that are important. I would say all the systems, I don't think we're incompatible with anything at this moment in time. That's very important for us to be compatible with all the ventilators and that are out there that are used. There's a little bit of noise from some of our compressors, so the software is able to reduce that noise. I don't think that was a big deal, but certainly, nicer for the hospitals to have that, and we're able to improve on the alarms. So that's really it. I think the compatibility and the sensor accuracy are probably the two biggest things that it did for us. So, that's it. I mean I would say those two things are really the driver for why we did this. And a little frustrating that it took as long as it did, but it's here now, and the feedback is as expected. Everybody is very pleased and happy with it. And like I said earlier, we're getting a lot of -- a lot more interest and a lot more looks from hospitals since we displayed this in early November at the American Academy of Respiratory Care.
Yale Jen: Okay. Maybe my last question here is that in terms of the NTM, just a company recently, AN2 Therapeutics, has a pause there Phase 2/3 study of a similar indication at this point based on I guess the efficacy as they indicated. Do you see any impact on your development in the LungFit go for this indication? Or any comments on that?
Steve Lisi: I'm sorry, what company was it that you were mentioning? I didn't hear the name.
Yale Jen: It's called AN2 Therapeutics and pause there.
Steve Lisi: Yeah, AN2 Therapeutics.
Yale Jen: Yes.
Steve Lisi: Yeah, I believe that these are using an antibiotic, is that correct?
Yale Jen: Right. And basically, they suggest that they have subpar efficacy, at least that they hinted in their press release and that's the reason they paused the Phase 2/3 study.
Steve Lisi: Look, anything that's positive for these patients is a big win. So, I'm very happy to hear that they may be able to help patients, that's fantastic. So, it's more options for these patients. They have very few. So, I think it's a good thing. And I think that it could even make the path easier through FDA, perhaps we have to see. We have to wait and see what happens with them. But right now, our studies are being done on top of antibiotic therapy. So, I think we would just be used together with antibiotics. I don't know if we're going to be doing any monotherapy studies in the near term. So, at this point, any success with antibiotics is great for us, great for patients. Nitric oxide enhances the efficacy and certainly helps with the tolerability of antibiotics as we've seen in our studies. So, I think they are all positive.
Yale Jen: I think they actually -- I think they paused their study because they don't have enough efficacy on their study.
Steve Lisi: It was a failure, Yale. I hadn't the data.
Yale Jen: Yeah.
Steve Lisi: So, it was stopped for negative reasons?
Yale Jen: For negative reasons. It's not the early stop.
Steve Lisi: Okay. Well, that's too bad again, these patients need options. So, we'll be hoping that things would work for them. So, it doesn't change our strategy at all. I mean, we're just going to be used with existing antibiotic background therapy. If there's any way we can go upfront due to [indiscernible] patients as a monotherapy, that would be great. But at this point in time, I think it's a little early to do that. But we'll speak with FDA, you never know. But in any case, this doesn't change our strategy. We are certainly a unique mechanism of action for treating NTM lung disease. So, it's not going to change the way we look at things. Our data speaks for itself. I mean we had very strong data in the last study we did, so we're pretty excited about it.
Yale Jen: Okay. Great. I appreciate it. Congrats on the progress at this moment.
Steve Lisi: Thanks, Yale. Appreciate it.
Operator: Our next question comes from the line of Marie Thibault with BTIG. Please proceed with your question.
Sam Eiber: Hey, good afternoon. This is Sam Eiber on for Marie. Thanks for taking the question this afternoon. Maybe I can start on the CE mark as we get closer to approval here. Just any thoughts on how to think about the ramp both in Europe and APAC? Any target markets that you'd highlight for us, revenue contribution? And anything included in the fiscal '25 guidance for international at this time?
Steve Lisi: Yeah. Sam, I don't think that we're going to have anything from the European Union in '25. I mean, we still have to get the CE mark, then we'll ink a deal and then we've got to ramp things up. It takes time in Europe. Australia, New Zealand, I think that the TGA approval in Australia will lag the CE mark, give or take, 90 days. I mean you can't be sure, but that's a rough estimate, and then we'll have to ramp things up. So, if there's any effect from there, it would be minimal in '25, fiscal '25. So, I wouldn't think it would be very impactful. I think that this is more of a fiscal '26, '27 impact for us on both fronts.
Sam Eiber: Okay. That's helpful to think about. And maybe I can just use my follow-up here on, some of the comments around adding to the field team. I guess just any way to quantify or think about that ramp here, and obviously, incremental contribution to operating expenses in the back half of this year and fiscal '25?
Steve Lisi: Yeah. I mean we already budget for this, right? In our budget, in our forecast, we already have people being added. And what we're doing now is adding based upon the interest in what we see coming our way, right? So, we need to be prepared for this. We need to bulk up our team a little bit for the interest in our system. So, it's in our budget. It's not going to change anything. Whether we are one or two people ahead or one or two people behind in a certain quarter, it's all going to smooth out over the next four, six quarters. I mean we're probably going to be where we are in four to six quarters. Just each quarter might be a little bit different in terms of who starts when. But this is all part of the plan. It's in our budget. It's in our guidance for burn, it's all there. This is nothing new. It's not going to increase our expenses. I mean it's exactly what we expect to happen when we see the demand coming, we're going to bring people on.
Sam Eiber: Okay. Well understood. Thanks for taking the questions, Steve.
Steve Lisi: Great. Thanks. Appreciate it.
Operator: Our next question comes from the line of Matt Kaplan with Ladenburg Thalmann. Please proceed with your question.
Matt Kaplan: Hey, guys, thanks for taking the questions. Just wanted to -- if you can give us a little bit more color on your -- why you're confident in your guidance in terms of the $12 million to $16 million for 2025? And what you need to see, I guess, in terms of conversions of some of these conversations that you're having with different hospitals to achieve that?
Steve Lisi: Thanks, Matt. So look, you don't win them all. There's no way we expect about 1,000 here, but we do expect to be winning a good portion of these discussions that we're having. What we need to see is keeping our existing customers, re-signing them because a lot of the re-signings are coming up in the next couple of months. I think that will be important. And it will also be important to bring on some new customers. What we need to see is June, July, August type things or where we believe we'll be bringing on significant numbers of new customers because we'll have already taken care of our existing customer base by every time we get out there, and we'll have time to build up our inventory to a point where we can take on more hospitals. So that's what we need to see. And we're already seeing it. We mentioned we had the new start, Feb 1. We had another start in February. So, it's two hospitals starting in the month of February, and we'll have more coming. I think we're going to be seeing hospitals, hospital starts every month, multiple hospital starts every month, hopefully, and the sizes will vary. Some are small, some are medium, some are big. We might even get lucky, Matt, to get one of those giant-size customers. We'll see. We'll see if we can break into that club of having some of the big, huge users of nitric oxide in the United States.
Matt Kaplan: Okay. Great. That's helpful. And then, in terms of the PMA supplement for cardiac surgery, obviously, the label and approval took a lot longer than you expected for initial indication. How is the review going? Is it just starting? And how do you expect it to progress? Is this something you expect to be completed later this year?
Steve Lisi: Matt, I don't like to comment on things I have no control over. But I think before the end of this calendar year is a fair assessment that we'll hear back from the FDA, one way or the other. It could be sooner than that. It could be the summer, it could be the fall. I mean it's very difficult to pinpoint it. And I don't want to give a hard date here. But I would say it's going to take more than 180 days that some people may think. So, please don't put 180 days. I don't think we're getting the approval in the month of May. I would think it's going to take several months beyond that. And right now, it's a pure guess on my part because the interactions with FDA, as you're aware, we're still a little bit short of when you would normally hear feedback from FDA. We're still a little bit of ways away from getting a full picture of FDA's first pass of our application. So that's just a guess on my part. We do feel confident in our application. We think that the data that have been generated are very strong. And we really look forward to discussing with FDA. I mean, my team can't wait. We're gearing up. We're sitting here twiddling our thumbs, trying to prepare, guess what questions will be asked and try to be ready for it. That's all we can do. So hopefully, next update in June I'll have a little bit more information for you. But right now, it's just our opinion.
Matt Kaplan: Great. All right. Well, thanks for taking the questions.
Steve Lisi: Perfect. Thanks, Matt. Appreciate it.
Operator: There are no further questions in the queue. I'd like to hand the call back to Steve Lisi for closing remarks.
Steve Lisi: Well, thanks, everyone, for tuning in. Much appreciated. We look forward to sharing with you our progress on the next call. Thank you.
Operator: Ladies and gentlemen, this does conclude today's teleconference. Thank you for your participation. You may disconnect your lines at this time, and have a wonderful day.
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