Q4 2025 Beyond Air Inc Earnings Call
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Unknown Attendee: Unknown Attendee. Featured on-screen text Transcribed by EDITED-JR-LF-MGN-DQ the Line, and Unknown Attendee, Beyond the Line, and Good afternoon and welcome everyone to the BeyondAIR financial results call for the fiscal quarter and year ended March 31st, 2021.
Good afternoon, and welcome everyone to the beyond their financial results call for the fiscal quarter and year ended March 31 2025.
Corey Davis: Time, participants are on a list of Question and Answer Session will follow the formal And now, I would like to turn the call over to Corey Davis with Lifestyle Advisors. Please go ahead.
At this time participants are in a listen only mode. A question and answer session will follow the formal presentation.
Corey Davis: Now I would like to turn the call over to Corey Davis with lifestyle advisors.
Speaker Change: Please go ahead.
Corey Davis: Thank you, operator.
Corey Davis: Good afternoon, everyone. Thank you for joining us today.
Speaker Change: Thank you operator, good afternoon, everyone and thank you for joining us today. After the market closed we issued a press release announcing the operational highlights and financial results for beyond there is fourth quarter of fiscal year 2025, ending March 31, 2025, a copy of this press release can be found on our website beyond their dot net under the news.
Steve Lisi: After the market closed, we issued a press release announcing the operational highlights and financial results for Beyond Air's fourth quarter of fiscal year 2025 ended March 31, 2025. A copy of this press release can be found on our website beyondair.net under the news and events section.
Speaker Change: In the events section.
Steve Lisi: 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 Security 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 SEC, 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.
Speaker Change: 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 result.
Speaker Change: To differ materially from those indicated we encourage everyone to review the company's filings with the SEC, 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.
Steve Lisi: Additionally, this conference call is being recorded and will be available for audio rebroadcast on our website, beyondair.net.
Speaker Change: It will be available for audio rebroadcast on our website beyond their dot 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 17, 2025 beyond Air undertakes no obligation to revise or update any statements to reflect events or circumstances. After the date of this call with that.
Steve Lisi: Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, June 17, 2025. Beyond Air undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call.
Steve Lisi: With that, I'll turn the call over to Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. Go ahead, Steve. Thanks, Corey. And good afternoon to everyone.
Steve Lisi: I'll turn the call over to Steve Lisi, Chairman and Chief Executive Officer of beyond Air Go ahead, Steve.
Steve Lisi: Thanks, Corey and good afternoon, everyone with me here today is Doug Larson, our Chief Financial Officer.
Steve Lisi: With me here today is Doug Larson, our Chief Financial Officer. We are quite pleased with the progress we've made over the past year. For the fiscal year ended March 31, 2025, we reported a 220% increase in revenue to $3.7 million, compared with $1.2 million for the same period last year. All of this growth came from U.S. sales, with the majority coming from hospitals signed during the back half of the year. As a result, we have tremendous revenue growth built in to kick off fiscal year 2026, along with several new growth drivers, as I will discuss in a moment.
Steve Lisi: We are quite pleased with the progress we've made over the past year.
Steve Lisi: For the fiscal year ended March 31, 2025, we reported a 220% increase in revenue to $3 $7 million compared with $1 2 million for the same period last year. All of this growth came from U S sales the majority coming from hospitals signed during the back half of the year.
Steve Lisi: As a result, we have tremendous revenue growth built in to kick off fiscal year 2026, along with several new growth drivers, which I will discuss in a moment with this in mind. We have decided to also announce that we are on track to report revenue of at least $1 7 million for the quarter ending in just two weeks on June 30th 2025, which.
Steve Lisi: With this in mind, we have decided to also announce that we are on track to report revenue of at least $1.7 million for the quarter ending in just two weeks on June 30, 2025, which translates to greater than a 45% sequential quarterly growth and greater than 145% year-over-year growth. In addition, we are providing revenue guidance of $12 to $16 million for the full fiscal year ending March 31, 2026. This level of projected growth moving forward shows how we are overcoming the barriers to entry in the nitric oxide market and are well on our way to making LungFitPH the market leader.
Steve Lisi: Translates to greater than a 45% sequential quarterly growth.
Steve Lisi: And greater than 145% year over year growth. In addition, we are providing revenue guidance of $12 million to $16 million for the full fiscal year ending March 31 2026.
Steve Lisi: This level of projected growth moving forward shows. So we are overcoming the barriers to entry and the nitric oxide market and are well on our way to making alongside ph the market leader.
Steve Lisi: The more customers use LungFitPH, the more confidence grows in the product and our ability to provide top tier service. This is an exciting time for our team and our shareholders.
Steve Lisi: The more customers use lumpy ph the more confidence grows in the product and our ability to provide top tier service. This.
Steve Lisi: This is an exciting time for our team and our shareholders.
Steve Lisi: Let me now dig a little deeper into the numbers for the fiscal fourth quarter of 2025 and growth drivers for fiscal 2026. The commercial team's efforts have led to a steady flow of new hospital contracts throughout fiscal year 2025. During the fourth quarter, we saw three new hospital starts and three hospitals renew their contracts. As I've mentioned recently, we have established a solid customer base across key target regions in the U.S. We are pleased and thankful that many of these customers have made themselves available as references for LungFitPH over recent months, which has proven to be a valuable tool when establishing new accounts.
Steve Lisi: Let me now dig a little deeper into the numbers for the fiscal fourth quarter of 2025 and growth drivers for fiscal 2026. The commercial team's efforts have led to a steady flow of new hospital contracts throughout fiscal year 2025. During the fourth quarter. We saw three new hospital starts and three hospitals renew their contracts.
Steve Lisi: As I've mentioned recently, we have established a solid customer base across key target regions in the U S. We are pleased and thankful that many of these customers have made themselves available as references for lumpy Peach over recent months, which has proven to be a valuable tool when establishing new accounts.
Steve Lisi: Further to the customer reference approach, we have partnered with Vanderbilt University Medical Center, naming them as the first luminary site for lung fit pH. Through this program, we will work alongside the Vanderbilt team to further optimize lung fit products and explore new opportunities to enhance hospital-based nitric oxide therapy. In addition, Vanderbilt has made themselves available to better showcase the full utility of lung fit pH technology to respiratory therapists, anesthesiologists, nurses, and other relevant clinicians at hospitals, considering adopting our cylinder free nitric oxide delivery system.
Steve Lisi: Further to the customer reference approach, we are partnering with Vanderbilt University Medical center naming them as the first luminary site for lung for ph.
Steve Lisi: Through this program, we will work alongside the random book team to further optimize long fit products and explore new opportunities to enhance hospital base nitric oxide therapy.
Steve Lisi: In addition, tangible has made themselves available to better showcase the full utility of.
Steve Lisi: Longford ph technology to respiratory therapist, anesthesiologists nurses and other relevant clinicians at hospitals, considering adopting our cylinder free nitric oxide delivery system. This collaboration marks a major milestone in our core mission to redefine tankless nitric oxide delivery and drive continued innovation and respiratory.
Steve Lisi: This collaboration marks a major milestone in our core mission to redefine tankless nitric oxide delivery and drive continued innovation in respiratory care.
Steve Lisi: Now I would like to update you on the status of LungFit PH2, our next generation system. As announced yesterday, we have submitted a PMA supplement to FDA. LungFit PH2 is smaller, lighter, and designed for air and ground transportation, while still delivering all the revolutionary features of the current FDA approved system. Additional improvements include a more intuitive user interface, more functional backup system, adjustable alarm volume, and significantly less frequent maintenance. All of these improvements were made with extensive input from our customers.
Steve Lisi: Sure.
Steve Lisi: Now I would like to update you on the status of lung fit ph two our next generation system as announced yesterday, we have submitted a PMA supplement to F. D. A lung fifth th two is smaller lighter and designed for air and ground transportation, while still delivering all the revolutionary features of the current FDA approved system.
Steve Lisi: Additional improvements include a more intuitive user interface more functional backup system adjustable arm volume and significantly less frequent maintenance.
Steve Lisi: All of these improvements were made with extensive input from our customers.
Steve Lisi: We anticipate that the anticipated FDA approval of the second-generation system and subsequent introduction to the U.S. market will have a major impact on our market share, total NO volume, and logistics within the hospital.
Steve Lisi: We anticipate that the anticipated FDA approval of the second generation system and subsequent introduction to the U S market will have a major impact on our market share total N O volume and logistics within the hospital.
Steve Lisi: Looking outside the U.S., over the course of just the past six months, we have quickly ramped up our commercial program across Europe, Southeast Asia, and the Middle East. These activities have included securing key regulatory approvals, including CEMARC, as well as signing distribution agreements across more than two dozen countries covering over two billion lives. Today, we announced that the team has recently signed several new international distribution partnerships for the following countries, India, Italy, Latvia, Lithuania, Estonia, Ukraine, Kuwait, Kazakhstan, Israel, and Poland.
Steve Lisi: Looking outside the U S over the course of just the past six months, we have quickly ramped up our commercial program across Europe, Southeast Asia, and the Middle East.
Steve Lisi: These activities have included securing key regulatory approvals, including CE, Mark as well as signing distribution agreements across more than two dozen countries covering over 2 billion lives.
Steve Lisi: Today, we announced that the team has recently signed several new international distribution partnerships for the following countries, India, Italy, Latvia, Lithuania, and Estonia, Ukraine, Kuwait, Kazakhstan, Israel and Poland.
Steve Lisi: As a reminder, because the LungFit system generates NO from room air, unlike other systems that require NO-filled cylinders, we are opening an enormous new opportunity in geographical areas around the world where hospitals are unable to obtain nitric oxide supply or do not use nitric oxide due to the logistical difficulties associated with cumbersome cylinder-based systems. I am pleased to report that we have already shipped more than a dozen units of LungFit pH to customers outside the U.S. over the course of just the past few weeks.
Steve Lisi: As a reminder, because the lung fits system generates N O for merman. Unlike other systems that require N O film cylinders.
Steve Lisi: Opening an enormous new opportunity in geographical areas around the world, where hospitals are unable to obtain nitric oxide supply or do not use nitric oxide due to logistical difficulties associated with cumbersome cylinder based systems.
Steve Lisi: I am pleased to report that we have already shipped more than a dozen units of lung <unk> ph to customers outside the U S. Over the course of just the past few weeks.
Steve Lisi: As a result, we plan to see a meaningful contribution from these activities reflected in our financial results starting in the back half of fiscal 2026 and beyond.
Steve Lisi: As a result, we plan to see any meaningful contribution from these activities reflected in our financial results starting in the back half of fiscal 2026 and beyond.
Steve Lisi: Turning to Beyond Cancer, as previously reported, they received regulatory approval in Israel to begin a Phase 1b trial for a low-volume UNO, or ultra-high-concentration nitric oxide, in combination with anti-PD-1 therapy in late-stage cancer patients who have failed anti-PD-1 therapy. This remains an area of high unmet patient need. Timing for the initiation of this study is under review.
Steve Lisi: Turning to be on cancer as previously reported they receive regulatory approval in Israel at the beginning phase one b trial for low volume.
Steve Lisi: Our ultra high concentration nitric oxide in combination with anti PD one therapy in late stage cancer patients, who have failed anti PD one therapy.
Steve Lisi: This remains an area of high unmet patient need.
Steve Lisi: Timing for the initiation of this study is under review.
Steve Lisi: On to Neuronas, a subsidiary focused on therapies for autism spectrum disorders. We were pleased to announce recently that the U.S. FDA granted orphan drug designation to our lead investigational therapy, BA102. which is being developed for the treatment of Phelan-McDermid syndrome, a syndrome associated with autism spectrum disorder. As many of you are aware, this designation provides key development incentives, including seven years of market exclusivity upon approval, tax credits for qualified clinical trials, waiver of FDA application fees, and access to FDA protocol assistance. Neuronauts will meet with FDA later this year to get an idea of the path to human studies, which we expect to begin late in calendar 2026.
Speaker Change: Entrepreneur and a subsidiary focused on therapies for autism spectrum disorders. We were pleased to announce recently that U S. FDA granted orphan drug designation to our lead investigational therapy be a one or two.
Steve Lisi: Which is being developed for the treatment of feeling Mcdermott syndrome syndrome associated with autism spectrum disorder.
Steve Lisi: As many of you are aware this designation provides key development incentives, including seven years of market exclusivity upon approval tax credits for qualified clinical trials waiver of ft application fees and access to FDA protocol assistance.
Steve Lisi: Nevertheless, we'll meet with FDA later this year to get an idea of the path to human studies, which we expect to begin late in calendar 2026.
Steve Lisi: The excitement around our autism program goes beyond our walls. This is evident by our ability to recruit leaders in the field to our scientific advisory board. Just recently, we announced the appointment of Nobel Prize Laureate Professor Dan Shechtman to the NeuroNOS SAB. We believe bringing in Professor Shechtman to join Professor Roger Kornberg from Stanford University on this board brings unparalleled scientific expertise to the NeuroNOS team.
Speaker Change: Excitement around our autism program goes beyond our walls. This is evident by our ability to recruit leaders in the field to our scientific Advisory Board. Just recently, we announced the appointment of Nobel Prize Laureate Professor Dan Chapman to.
Steve Lisi: So the neuro <unk> S. A b, we believe bringing in professors Shuchman's, who joined professor Roger Kornberg from Stanford University on this board brings unparalleled scientific expertise to the <unk> team.
Steve Lisi: During the March quarter, NeuroNOS published a peer-reviewed journal, article in Translational Psychiatry, which presented breakthrough research by its Chief Scientific Officer, Professor Haitham Amal, which shows compelling evidence of a novel mechanism in the early stages of Alzheimer's disease. These new preclinical data further underscore the consistency and power of NeuroNASA's platform and offers new hope for the development of effective therapies for this devastating condition.
Steve Lisi: During the March quarter neuronal published a peer reviewed journal article in translational Psychiatry, which presented breakthrough research bites Chief Scientific Officer Professor Hyphen, My model, which shows compelling evidence of a novel mechanism in the early stages of Alzheimer's disease.
Steve Lisi: These new preclinical data further underscore the consistency and power of <unk> platform and offers new hope for the development of effective therapies for this devastating condition.
Steve Lisi: Building on the excitement around the data and progress of its programs, Neuronos announced at the end of March that it completed a $2 million equity financing from private investors as part of a larger funding round. This investment will accelerate the preclinical development of Neuronos' small molecule drug, designed as an injectable or oral treatment for children with autism.
Steve Lisi: Building on the excitement around the data and progress of its programs Neuro Nasser announced at the end of March that had completed a $2 million equity financing from private investors as part of a larger funding round. This investment will accelerate the preclinical development of neuro not just small molecule drugs.
Steve Lisi: As an injectable or oral treatment for children with autism.
Steve Lisi: Turning to the corporate side, we're excited to announce today the appointment of Bob Goodman to our Board of Directors, effective June 13th, 2025. Bob is a seasoned health care executive and board director who brings decades of commercial leadership experience from across the medical technology, pharmaceutical services and medical device industries. His career has included executive roles at Biotelemetry, Phillips Healthcare, CardioCore, Thermo Fisher and Pfizer. Our board and management team look forward to working with Bob as we continue to build positive momentum across the commercial side of our business.
Speaker Change: Turning to the corporate side, we're excited to announce today the appointment of Bob Goodman to our board of directors effective June 13th 2025.
Speaker Change: Bob is a seasoned healthcare executive and board director, who brings decades of commercial leadership experience from across the medical technology pharmaceutical services and medical device industries.
Speaker Change: His career has included executive roles at Biotelemetry, Philips healthcare cardio core Thermo Fisher and Pfizer.
Speaker Change: Our board and management team look forward to working with Bob as we continue to build positive momentum across the commercial side of our business.
Steve Lisi: Before I conclude my comments today, I want to mention that our Lung Fit Go program is still moving along. We are dedicated to bringing this therapy to market to improve the lives of patients suffering with lung infections. We plan to meet with FDA prior to year end to discuss the clinical path forward. We continue to make significant progress in executing against the strategies for each of our businesses.
Speaker Change: Before I conclude my comments today I want to mention that our lung fit go program is still moving along we are dedicated to bringing this therapy to market to improve the lives of patients suffering with lung infections, we plan to meet with FDA prior to year end to discuss the clinical path forward.
Speaker Change: We continue to make significant progress in executing against the strategies for each of our businesses.
Steve Lisi: Past years show just a glimpse of how LungFitPH will transform the global NO landscape for the better and gives us a solid foundation from which to continue to build. The idea team will continue to be diligent on its path to profitability and improving the lives of patients in need of the benefits of nitric oxide.
Speaker Change: Past year show, just a glimpse of how long <unk> ph will transform the global <unk> landscape for the better and gives US a solid foundation from which to continue to build.
Speaker Change: Beyond their team will continue to be diligent on its path to profitability and improving the lives of patients in need of the benefits of nitric oxide now I will turn it over to our CFO Doug Washington.
Douglas Larson: Now I will turn it over to our CFO, Doug Larson. Thanks, Steve, and good afternoon, everyone. Our financial results for the fourth quarter of fiscal year 2025, which ended March 31st, 2025, are as follows. Revenue for the fiscal year ended March 31, 2025 increased 220% to $3.7 million, compared with $1.2 million for the fiscal year ended March 31, 2024. We're showing $1.7 million loss in gross profit for the fiscal year 2025 compared to $1.3 million for fiscal year 2024. Cost of revenue of $5.4 million were recognized in the fiscal year, compared with $2.5 million in the fiscal year and March 31, 2020.
Doug Washington: Thanks, Steve and good afternoon, everyone.
Doug Washington: Our financial results for the fourth quarter of fiscal year 2025, which ended March 31, 2025 are as follows.
Doug Washington: Revenue for the fiscal year ended March 31, 2025 increased 220% to $3 7 billion.
Doug Washington: Compared with $1 $2 million for the fiscal year ended March 31 2024.
Doug Washington: We're showing $1 $7 million loss in gross profit for the fiscal year 2025, compared to $1 $3 billion for fiscal year 2024.
Speaker Change: Cost of revenue of $5 $4 million were recognized in the fiscal year.
Speaker Change: Compared with $2 $5 million in the fiscal year ended March 31 2024.
Douglas Larson: Cost of revenue exceeded revenue primarily driven by the depreciation of loan fit devices and one time upgrade costs to system. Research and development expenses were $16.9 million for fiscal year 2025, compared with $24.4 million for fiscal year ended March 31, 2024. The decrease of $7.5 million was primarily attributed to a decrease in salaries, stock-based compensation, and to a lesser extent, from clinical and preclinical study expenses. SG&A expenses for the year ended March 31st, 2025 and March 31st, 2024 for $26 million and $37.3 million respectively. A decrease of $11.3 million was attributed primarily to a reduction in salaries and stock-based compensation costs.
Speaker Change: Cost of revenue exceeded revenue, primarily driven by the depreciation of lung fit devices at one time upgrade costs to systems.
Speaker Change: Research and development expenses were $16 9 million for fiscal year, 2025, compared with $24 $4 million for the fiscal year ended March 31 2024.
Speaker Change: The decrease of $7 $5 million was primarily attributed to a decrease in salaries stock based compensation and to a lesser extent from clinical and preclinical study expenses.
Speaker Change: SG&A expenses for the year ended March 31, 2025, and March 31, 2024, or $26 million and $37 $3 million respectively.
Speaker Change: The decrease of $11 $3 million was attributed primarily to a reduction in salaries and stock based compensation costs.
Douglas Larson: Other expense was $3.9 million compared to $1.3 million a year ago. The increase in other expense of $2.6 million was mainly due to a non-cash loss recorded upon the retirement of Avenue Capital debt. Net loss attributed to common stockholders of Beyond Air, Inc. was $46.6 million or a loss of 69 cents per share basic and diluted. Our net loss for the fiscal year ended March 31, 2024 was $60.2 million, or a loss of $1.82 per share of basic end delivery. Net cash burn for the year was $44.1 million, which is more than 28% lower than previous year.
Speaker Change: Other expense was $3 $9 million compared to $1 $3 million a year ago.
Speaker Change: The increase in other expense of $2 $6 million was mainly due to a noncash loss recorded upon the retirement of Avenue capital debt.
Speaker Change: Net loss attributed to common stockholders of beyond Air Inc, was $46 $6 million or a loss of <unk> 69 per share basic and diluted.
Speaker Change: Our net loss for the fiscal year ended March 31, 2024 was $60 2 million or a loss of $1 82 per share basic and diluted.
Speaker Change: Net cash burn for the year was $44 $1 million, which is more than 28% lower than previous year.
Douglas Larson: We've talked in previous quarters how we've been laser focused on fixed cost reduction in R&D and in our supply chain. Now that we're wrapping up spend on development of our next generation lung fit device, we'll see further reduction in our cash burn in Q1 and again in Q2.
Speaker Change: We've talked in previous quarters, how we've been laser focused on fixed cost reduction in R&D and in our supply chain.
Speaker Change: Now that we're wrapping up spend on development of our next generation lung fit device will see further reduction in our cash burn in Q1 and again in Q2.
Douglas Larson: I would like to take a moment and expand a bit on our cost reduction effort. Over the past six quarters, we produced operating expenses from north of $17 million to just above $7 million in the current quarter. Translates to a 58% reduction. We believe the trough and our operating expenses will either be in the coming June quarter or the September quarter. Please do not interpret that expenses will be moving up significantly in the December quarter. Expenses will move up in proportion to our commercial performance to maintain our excellence in service and take advantage of coming opportunities.
Speaker Change: I would like to take a moment and expand a bit on our cost reduction efforts.
Speaker Change: Over the past six quarters, we've reduced operating expenses from north of $17 million to just above $7 million in the current quarter.
Speaker Change: This translates to a 58% reduction.
Speaker Change: We believe the trough in our operating expenses will either be in the coming June quarter for the September quarter.
Speaker Change: Please do not interpret that.
Speaker Change: <unk> will be moving up significantly in the December quarter expenses will move up in proportion to our commercial performance to maintain our excellence in service and take advantage of coming opportunities as.
Douglas Larson: As of March 31, 2025, the company had cash, cash equivalents and marketable securities of $6.9 million. Please note this does not include the $1 million payment we received from Getz Healthcare, nor the additional $2 million investment into our existing synthetic royalty debt structure, both of which we received after March 31st, 2025. We believe our cash, cash equivalents, marketable securities and existing financing vehicles will be sufficient to allow us to support our current operating plans well into calendar 2026 and potentially to profitability, provided we continue to hit our internal revenue estimates and control costs that beyond it.
Speaker Change: As of March 31, 2025, the company had cash cash equivalents in marketable securities of $6 9 million.
Speaker Change: Please note. This does not include the $1 million payment, we received from Getz healthcare, nor the additional $2 million investment into our existing synthetic royalty debt structure, both of which were received after March 31 2025.
Speaker Change: We believe our cash cash equivalents marketable securities and existing financing vehicles will be sufficient to allow us to support our current operating plans well into calendar 2026, and potentially to profitability provided we continue to hit our internal revenue estimates and control costs that beyond there.
Steve Lisi: With that, I'll hand the call back Thanks, Doug. We'll now take some questions. Operator. Thank you.
Steve Lisi: With that I'll hand, the call back to Steve.
Steve Lisi: Thanks, Doug.
Speaker Change: We'll now take some questions operator.
Unknown Attendee: We'll now be conducting a question and answer. If you would like to ask a question, please press star 1 on your telephone. Confirmation Tom will indicate your line You may press star two if you'd like to remove your Participants using speaker equipment, it may be necessary to pick up your handset before pressing the start button.
Speaker Change: Thank you well now be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad.
Steve Lisi: Confirmation tone will indicate your line is in the question queue.
Steve Lisi: Press Star two if you'd like to remove your question from the queue.
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Unknown Attendee: One moment, please, lollipop. Thank you.
Steve Lisi: One moment, please while we poll for questions.
Steve Lisi: Okay.
Marie Thibault: Our first question is from Marie Thibault with BTI Hi, good afternoon, and congrats on the progress here. I wanted to ask my first question here about LungFit 2.0. Great to see that get in. I wanted to understand if that system approval is being assumed in the fiscal year 26 guidance range that you've given us, and how we should think about the selling dynamics ahead of that potential approval. Is that something where hospitals see that coming approval and say, hey, I want to get exposure to LungFit before that comes out? Is it, you know, they wait a little bit as they're waiting for that next-gen system?
Speaker Change: Thank you our first question from Marie Thibault with BTG.
Marie Thibault: Hi, good afternoon, and congrats on the progress here I wanted to ask my first question here about lung fits your 0.0 great.
Steve Lisi: Great to see that get in wanted to understand if that system approval is being assumed in the fiscal year 'twenty six guide.
Steve Lisi: Guidance range that you've given us and how we should think about the selling dynamics ahead of that potential approval is that something where hospitals see that coming approval and say, hey, I want to get exposure to lung set before that comes out is it.
Steve Lisi: Hey, wait a little bit as they're waiting for that nexgen system or help us think about some of those dynamics.
Steve Lisi: Help us think about some of those dynamics.
Steve Lisi: Thanks, Marie.
Steve Lisi: Sure.
Steve Lisi: Fiscal 26 guidance does not include the second generation system at all. And to answer your other question, you know, we don't promote the Gen 2, obviously, until we get approval. So people know it exists, obviously, and they do inquire. But I think it's, you know, the focus is on Gen 1. That's what we're promoting now, and that's what we're marketing and pushing. And yeah, I mean, obviously, there are some hospitals that are interested in getting exposure to Gen 1 immediately. And then there are others who will choose to wait. So we've seen both. Okay, very encouraging.
Speaker Change: Thanks Marie fiscal 'twenty six guidance does not include the second generation system at all.
Speaker Change: And to answer your other question.
Speaker Change: We don't we don't promote the Gen. Two obviously until we get approval. So people know what exists obviously and they do inquire, but I I think it's you know the focus is on Gen. One that's we're promoting now and that's what we're marketing and pushing and yeah. I mean, obviously there are some hospitals that are interested in getting exposure to gen. One.
Speaker Change: And then there are others, who who will will choose to wait.
Speaker Change: So we've seen both at this point.
Marie Thibault: Very helpful, Steve.
Speaker Change: Okay very encouraging very helpful. Steve wanted to ask also about are you asking if <unk> gotten several shipments out there it sounds like hum of units.
Marie Thibault: Want to ask also about OUS, you've, you know, gotten several shipments out there, it sounds like, of units. What are we understanding about what some of those contracts look like? Is there any difference in how hospitals use this versus, you know, how they use it within US hospitals? Any trends or specific countries we should be looking toward or any other catalysts OUS? Just want to get a little closer to that market. Yeah, I think it's a little early for us to see any trends in actual hospitals outside the US. Right now our shipments or initial shipments to distributors, and they're taking those and using them for demonstration to to get interest to have hospital placements.
Steve Lisi: What are we understanding about what some of those contracts look like is there any difference in how hospitals use this versus how they use it within U S hospitals are any trends or specific countries, we should be looking toward or any other countless O U S. Just wanted to get a little closer to that market.
Speaker Change: Yeah, I think it's a little early for us to see any trends in actual hospitals outside the U S. Right now our shipments are initial.
Speaker Change: Initial shipments to distributors.
Speaker Change: And they're taking those and using them for demonstration too to get interest to have hospital placements and there's a much more of a tender process outside the United States and in the U S. So it takes a little bit longer to get into the hospitals.
Steve Lisi: And there's a much more of a tender process outside the United States and in the US. So, it takes a little bit longer to get into the hospitals.
Steve Lisi: So, I think the back half of this fiscal year, we'll see a big upswing on the international side as we get hospital placements and we'll get some trends at that point. But our initial work in the market outside the US showing consistency in terms of how they use nitric oxide. You know, outside the US cardiac surgery is on label. So they're, they're definitely using it in that in that area. But again, it's similar to how it's used in the United States. Okay, very helpful update. Thanks a lot.
Speaker Change: So I think the back half of this fiscal year, we'll see a big upswing on the international side as we get hospital placements and we'll get some trend at that point, but our initial work are in the market outside the U S. Showing you know consistency in terms of how they use nitric oxide.
Speaker Change: Outside the U S cardiac surgery is on label.
Speaker Change: So they're they're definitely using it in that in that area, but again, it's similar to how it's used in the United States.
Speaker Change: Okay.
Speaker Change: Helpful. Thanks, Thanks, a lot Steve.
Marie Thibault: Thanks, Marie. Thank you.
Speaker Change: Thanks Marie.
Jason Wittes: Our next question is from Jason Wittes with Rockwell. Hi, thanks for the questions and congrats on the progress here on the PMA submission. Do you have an expected timeline for when we may see an approval for that? for that, for, for one fit for two. Jason, did you ask me when FDA is going to approve it? I just do have a estimate is what I'm asking. And I guess I was I'd add to that. How should we think about a potential launch? I think you had indicated earlier that it's kind of stage launch versus an immediate bolus type hit.
Speaker Change: Thank you. Our next question is from Jason <unk> with Roth capital.
Jason: Hi, Thanks for the questions and congrats on the progress here.
Speaker Change: On the PMA submission do you have unexpected a timeline for when we may see an approval for that.
Jason: For that for.
Jason: For one could far too.
Jason: Okay.
Jason: Jason did you you asked me when FDA is going to approve it.
Jason: Do you have a estimate is what I'm, asking I guess I would add to that.
Jason: How should we think about a potential launch I think you had indicated earlier that it's kind of.
Speaker Change: Stage launch versus an immediate bolus type here, just curious about the dynamics around.
Jason Wittes: I'm just curious about the dynamics around what we might when the FDA approves this device.
Speaker Change: What we might have.
Speaker Change: When the FDA approves this device.
Steve Lisi: Okay, so yeah, I'm going to stay away from the exact timing on on an FDA approval. You know, everybody kind of knows what's going on at FDA right now, there's a little bit of an upheaval. So let's just kind of let things settle in. It'll take a few months for us to interact with FDA and get a better understanding of their questions on our on our application. And, you know, perhaps, you know, I can give some more more timelines or better guidance on timing at that moment in time. But as for the launch for Gen 2, you know, obviously we're going to prep for that as we work with FDA.
Speaker Change: Okay. So yeah, I'm I'm going to stay away from the exact timing on on an FDA approval.
Speaker Change: You know everybody kind of knows what's going on at FDA right now, there's a little bit of an odd people. So, let's just kind of let things settle in and it'll take a few months for us to interact with FDA and get a better understanding of their questions on our on our application and you know, perhaps I can give some more moriarty.
Speaker Change: Timelines are better than our guidance on timing at that moment in time, but.
Speaker Change: But as for the launch for Gen. Two you know, obviously, we're where we're going to prep for that as we worked with F. D. A.
Steve Lisi: There's always a period where you need to build up inventory and you need to scale up your manufacturing. So it will take a couple of months, and then we will try to keep up with demand. That will probably be the challenge that we have post-approval. That's a totally appropriate answer, I get it. And then, you know, appreciate the guidance, which looks quite strong. We're at the low end. There's a big range there.
Speaker Change: There's always a period, where you need to build up inventory and you need to scale up your manufacturing. So it will take a couple of months.
Speaker Change: And then we will try to keep up with demand that will probably be the challenge that we have.
Speaker Change: Post approval.
Speaker Change: Okay.
Speaker Change: I totally appropriate answer I got it.
Speaker Change: And then you know I appreciate the guidance, which looks quite strong.
Speaker Change: We're at the low end and there's a big range. There I mean, what what what has what has to happen to get towards to the higher end of that range for that 12 to 16 million that you're kind of.
Steve Lisi: I mean, what has to happen to get to the higher end of that range for the $12 to $16 million that you're kind of pointing to for 2026? Yeah, it's not really that big of a range. I mean, $4 million range, I guess it seems that way, because it's a small, you know, 12 to 16. It's not 100 to 104%. Percentage wise, certainly, but dollar wise, go ahead. But you know, I mean, you know, you can get a couple of contracts that are a good size, and it can move you a few million dollars, you know, we can get, you know, some approvals, regulatory approvals overseas for some big countries and get some big orders in.
Speaker Change: Hinting arrow pointing to for 'twenty 'twenty six.
Speaker Change: Yeah.
Speaker Change: It's not really that big of a range I mean four.
Speaker Change: $4 million range, I guess, it seems that way because it's a small down 12 to 16 is not a 100 to 104 percentage wise, but right yeah, but you know I mean, you know you you can get a couple of.
Speaker Change: Contracts that that are a good size and it can move you a few million dollars we can get.
Speaker Change: No some some approvals regulatory approvals overseas for some big countries in and get some some big orders and so you know it it is not to us it's not that big of a range because things can swing dramatically with some of the things that we have going on in the pipeline.
Steve Lisi: So, you know, it's not to us, it's not that big of a range, because things can swing dramatically with some of the things that we have going on in the pipeline. So, you know, that's kind of how we view it. We look at it as we feel pretty comfortable getting to the low end of that. There are a couple of things in the works that could get us into the middle upper range of that. And, you know, if anything changes, we'll update you. I mean, I know the next call we have is in August, so there might not be any kind of change at that point.
Speaker Change: So that's.
Speaker Change: That's kind of how we view it we we look at it as we feel pretty comfortable getting to the low end of that.
Speaker Change: There are a couple of things in the works that could get us into the mid or upper range of that and.
Speaker Change: If anything changes, we'll update you I mean I know the next call. We have is in early August so they might not be any kind of change at that point, but certainly by November we'll have a good idea of of how were looking for getting into the range or.
Steve Lisi: But certainly by November, we'll have a good idea of how we're looking for getting into the range or, you know, perhaps, you know, maybe we get lucky, maybe it'll be at the high end or higher. We just don't know at this point. There's too many moving parts. And it's only June. So it's exciting. Got it. That's helpful.
Speaker Change: Perhaps maybe we get lucky maybe it'll it'll be at the high end or higher we just don't know at this point, there's there's too many moving parts.
Speaker Change: And it's only June so it's exciting for us.
Speaker Change: Got it that's helpful and then maybe just another clarification.
Steve Lisi: And then maybe just another clarification on, did I hear correctly? So basically, on the expense line, there'll be further reductions until expected through September, and then you basically grow with revenues on the expense line. Is that the right way to think about modeling the P&L? Yes, exactly. That's all I got.
Speaker Change: Did I hear correctly, so basically on the expense line.
Speaker Change: There'll be further reductions until expected through September then you basically grow with revenues and on the expense line is up is that the right way to think about modeling the P&L.
Speaker Change: Yes.
Speaker Change: Exactly.
Jason Wittes: Thanks and congrats on the PMA submission.
Speaker Change: That's all I got thanks, and congrats on the PMA submission.
Speaker Change: Thanks, Jason.
Justin Walsh: Our next question is from Justin Walsh with Jones Hi, thanks for taking the question. Now you guys are supplying globally.
Speaker Change: Our next question is from Jonathan Walsh with Jones trading.
Jonathan Walsh: Hi, Thanks for taking my question.
Jonathan Walsh: Now you guys are supplying globally I was wondering I guess the degree to which you're seeing impacts are worried about impacts from some of the emerging geopolitical questions. I mean, we have.
Steve Lisi: I was wondering, I guess, the degree to which you're seeing impacts or worried about impacts from some of the emerging geopolitical questions. I mean, we have a moving target with US tariffs, and you mentioned that you're supplying to Ukraine, and of course, you have ties in Israel. So just curious how all of that is impacting things You know, I don't think it's impacting us that much. I mean, we manufacture in the United States for for the long fit. So the vast majority of our costs are in the US, we do source some, some parts from from outside the US.
Jonathan Walsh: Moving target with U S tariffs and you mentioned that you're supplying to Ukraine and of course <unk>.
Jonathan Walsh: In Israel. So just curious how how all of that is is impacting things or not.
Jonathan Walsh:
Jonathan Walsh: I don't think it's impacting us that much I mean, we we manufacture in the United States for the lung fit.
Jonathan Walsh: So the vast majority of our costs are in the U S. We do source some some parts from from outside the U S. But it's not a major impact if those tariffs and some of the big ones that are going to stay in place. It's a it's a low single digit percentage impact on our cost of goods.
Steve Lisi: But it's not a major impact. If those tariffs and some of the big ones that are going to stay in place. It's a it's a low single digit percentage impact on our cost of goods. So it's not a major impact on us. And on the reverse side, we haven't really seen anything about where we're shipping to in terms of tariffs on the other end at this point.
Jonathan Walsh: It's not a major impact on us and on the reverse side, we haven't really seen anything about where we're shipping to in terms of tax on the other end at this point.
Steve Lisi: And as for Israel and Ukraine, I mean, honestly, it wasn't a. you know, Israel's great to be in. It's not a large country, but it will impact our ex-US sales. We're very happy to be there, but I don't think it's a major driver like a France or a Turkey or an Australia, India. You know, these are much bigger countries where we are. And to be honest, we were very surprised and happy that the distributor that we're working with in Eastern Europe had Ukraine on their list. So we're very excited to be able to help the distributor there go into Ukraine, but we didn't, that we didn't have any expectations for.
Speaker Change: And as for Israel in Ukraine, I mean honestly.
Speaker Change: Wasn't.
Speaker Change: You know Israel is always great to be in it's not a large country.
Speaker Change: But it will impact our our ex U S sales were very happy to be there, but I don't think it's a major driver like France, or Turkey or in Australia, India. These are much bigger countries, where we are and to be honest, we were very surprised.
Speaker Change: Surprised and happy that the distributor.
Speaker Change: But we're working with.
Speaker Change: In Eastern Europe had Ukraine on their list. So we're very excited to be able to help the.
Speaker Change: The distributor, they're going to Ukraine, but we didn't have any expectations for it. So that's just that's just upside.
Steve Lisi: So that's just, that's just upside.
Steve Lisi: Great. And maybe just to follow up on that, I'm, I'm curious, if you're seeing more uptake in some of those geographies, or, or where you think some of the markets might be a little bigger. I mean, obviously, you just mentioned a couple of them, but I'm wondering if you're, I don't know, really think you'll take off in India or, or, or somewhere in particular. Yeah, I mean, it depends, like, they're all different in terms of regulatory timing. So India, we have a partner, but there's there's a regulatory process to go through. So the impact from India on this fiscal year will be minimal.
Speaker Change: Great and maybe just a follow up on that and I'm curious if you're seeing more uptake in some of those geographies or or where you think some of the markets might be a little bigger I mean, obviously you just mentioned a couple of them, but I'm wondering if your I don't know really I think youll take off in India or somewhere in particular.
Speaker Change: Yeah, I mean, it depends like they're all different in terms of regulatory timing. So India, we have a partner, but there's a regulatory process to go through so on.
Speaker Change: The impact from India on this fiscal year will be minimal.
Steve Lisi: and, you know, Some of the other countries where like Australia, Thailand, France, Romania, Turkey, these places, the regulatory process is already done or a very short time. So we'll get some more impact from them. But it's, like I said earlier, an earlier question, it's a little too early because there are tender processes in a lot of these countries. So it takes time to get in to some hospitals. So we're going to wait the next three, four, five months to see how those go and how many we get and how quickly we get in. And every country is different.
Speaker Change: And.
Speaker Change: Some of the other countries, where like Australia, Thailand.
Speaker Change: France, Romania.
Speaker Change: Turkey. These places in the regulatory process is already done or very short time, So we'll get some more impact from them, but it's like I said earlier I really a question, it's a little too early because.
Speaker Change: Because there are tender processes and a lot of these countries. So it takes time to get in to some hospitals. So we're going to wait. The next you know 345 months to see how those go and how many we get at how quickly we get in.
Speaker Change: And every country is different so this is new for us as a company and new for this product even our international team who has experience with this.
Steve Lisi: So this is new for us as a company and new for this product. Even our international team who has experience with this, this is a new product. I mean, no one's ever seen a non-cylinder based nitric oxide system outside the United States before and certainly not one that makes it from ambient air. So this is kind of new for everybody. And we have some distributors are extremely excited, jumped at the opportunity, and it was a very quick process to sign them up. And others are a little, you know, kind of more skeptical, I think, because they can't believe what the machine does.
Speaker Change: This is a new product or I mean, no one's ever seen a non cylinder based nitric oxide system outside the United States before and.
Speaker Change: Certainly not one that that makes it from ambient air. So this is kind of a new for everybody and we have some distributors are extremely excited jumped at the opportunity and it was very quick process to sign them up and others are a little you know kind of more skeptical I think because they cant believe the what the machine does so.
Steve Lisi: So.
Steve Lisi: I think we're just in the early stages and it's exciting and we'll probably have a better idea maybe on the next call or the call after that of where we're going to move quickly and which countries are going to move fastest. But right now it's just kind of feeling it out and we're excited to have this many partners and this many countries open to us at this moment in time.
Speaker Change: I think we're just in the early stages and it's exciting and we will probably have better idea maybe on the next call or the call after that too.
Speaker Change: Where we're going to move quickly and which countries are going move fastest but right.
Speaker Change: Right now, it's just kind of feeling it out and we're excited to have this many partners in this many countries open to us at this moment in time.
Justin Walsh: Great.
Justin Walsh: Thanks for taking the questions. Thanks, Justin.
Speaker Change: Great. Thanks for taking the questions.
Jeff: Thanks, Jeff.
Yale Jen: Our next question is from Yale Jen with Laidlaw, New York. Good afternoon, and thanks for taking the questions, and congrats on the guidance as well as the performance. We just got about three here. The first one is that you suggested you will have more than 1.7 million for the next quarter, or current ongoing quarter, actually, and 12 to 16 for the fiscal 26. So what's the confidence you can provide behind these forecasts or projections? And I have a follow-up. Thanks, yeah. I mean, we're pretty confident we wouldn't have put it out if we weren't. I think the fact that the June quarter ends in two weeks, we're pretty confident it'll be 1.7 million.
Speaker Change: Our next question is from Yale Jen with Laidlaw <unk> company.
Yale Jen: Good afternoon, and thanks for taking the questions and congrats on the guidance as well as the <unk>.
Speaker Change: The performance, we just got its above three here. The first one is that are.
Speaker Change: You suggest that you will.
Speaker Change: More than $1 7 million.
Speaker Change: The next quarter or.
Speaker Change: <unk> actually.
Speaker Change: And 12 to 16 for the fiscal with when do you say so what.
Speaker Change: So what's the confidence you can provide.
Speaker Change: Provide that that's behind this.
Speaker Change: Uh-huh forecast, though projections.
Speaker Change: A follow up.
Speaker Change: Thanks, Yeah, I mean, we're pretty confident we wouldn't put it out if you Werent I think the fact that the June quarter ends in two weeks, where we're pretty confident it'll be $1 7 million yeah. There could be something that happens in next two weeks to bump it up a bit.
Steve Lisi: You know, it could be something that happens in the next two weeks to bump it up a bit. We can't really predict that. But we're highly confident in that number. And as for the, you know, the fiscal year, we're pretty confident. I mean, we've got a lot in the hopper here, especially on the international side. Even in the US, there's movement in some areas that, you know, we're excited to see and maybe happening a little bit sooner than we thought. So I'll give you an example. You know, we We're very flexible with the customers and how they want to structure their contracts.
Speaker Change: We can't really predict that but oh, we're highly confident in that number and.
Speaker Change: As for the you know the.
Speaker Change: Fiscal year you were.
Speaker Change: We're pretty confident I mean, we've got a lot in the hopper here.
Speaker Change: Especially on the international side, even in the in the U S. There's movement in some areas that are.
Speaker Change: Where we're excited to see and maybe happening a little bit sooner than we thought so I'll give you an example.
Speaker Change: We.
Speaker Change: We have we're very flexible with the customers and how they want to structure their contracts.
Steve Lisi: It's very easy with our system to be as flexible as they would like us to be. But one of the things we started offering earlier this year is the razor, razor blade model. So the purchase of our system and then the ongoing purchase of the consumables, which is mainly the filter. And we've gotten some good feedback over the last month or two on that model. So we may actually see some hospitals jumping at the opportunity for that rather than the more traditional nitric oxide model, which is how many hours do you use, X amount, this is what your annual costs could be, divided by 12, and you get paid that per month.
Speaker Change: It's very easy with our system to be as flexible as as they would like us to be.
Speaker Change: But one of the things we started offering earlier this year is the razor razorblade model. So the purchase of our system and then the ongoing purchase of the consumables ink, which is mainly the filter.
Speaker Change: And we've gotten some some good feedback over the last month or two on that model. So we may actually see.
Speaker Change: Some hospitals jumping at the opportunity for for that rather than.
Speaker Change: More traditional nitric oxide model, which is how many hours you use X amount. This is what your annual costs could be divided by 12 and you get paid that per month.
Steve Lisi: That's really the main way it's done. But we're offering this other way of doing it with the purchase model. And, you know, we may see some of that in this fiscal year. And that's exciting.
Speaker Change: That's really the main way, it's done, but we're offering this other way of doing it with the purchase model and we.
Speaker Change: We may see some of that in this fiscal year and that that's exciting and that gives us some confidence in our numbers because.
Steve Lisi: That gives us some confidence in our numbers because It wasn't something we were we were seeing six, nine months ago at all. Okay, great. That's very helpful and comforting. And also in the press release you mentioned you have about 45 hospitals in the United States now either installed or actually as well as using the along with assistance. And so, going toward, let's say, end of this year, fiscal years, or maybe, or calendar years of this end of this year, do you anticipate, what might be the estimate or projection of the number of hospitals that you may have, as well as maybe whether you would also see the volume increase per hospital?
Speaker Change: It wasn't something we were we were seeing six to nine months ago at all.
Speaker Change: Okay, Great that's very helpful I'm confident comforting.
Speaker Change: Also in the press release, you didn't mention you have off 45 hospitals in the United States.
Speaker Change: They're installed or actually that's why are they using the.
Speaker Change: Assistance, So Boeing tour, let's say.
Speaker Change: This year fiscal year, so maybe EBIT or calendar year itself. This end of this year.
Speaker Change: Do you anticipate.
Speaker Change: What might be the estimate all protection of the number of hospitals or you may have.
Speaker Change: As well as maybe whether you will also see the Bonnie increase per hospital.
Speaker Change: Okay.
Speaker Change:
Steve Lisi: Yeah, I definitely see the volume increasing per hospital. We've been seeing that for the past year and a half. A lot of our hospitals are going over what their estimate was for the year. That's a good thing. You know, we do offer a discounted hourly rate if they go over. So, certainty of price is important for the customer. So, I think that may continue. Hopefully, hospitals can get, you know, work with us and get a better handle on what they're going to use for the year so there's certainty in what they're spending. I don't want to speculate on the total number of hospitals we're going to have at the end of the fiscal year.
Speaker Change: Yes.
Speaker Change: I definitely see the volume increasing per hospital, we've been seeing that for the past year and a half a lot of our hospitals are going over what their estimate was for the for there for the year. That's a good thing we do we do offer a discounted hourly rate if they go over so certainty of price is important for the customer so.
Speaker Change: I think that May continue hopefully hospitals can get it.
Speaker Change: Work with us and get a better handle on what theyre going to use for the year. So there's certainty in what they are spending.
Speaker Change: I I don't want to speculate on the total number of hospitals, we're going to have at the end of the fiscal year.
Speaker Change: While its important well it's important.
Yale Jen: While it's important, you know, not every hospital is created equal. So, some hospitals are small in terms of their volume and some are very large in terms of their volume. So, we could have one hospital be worth 10 in some cases. So, obviously, 45 is a great number. I certainly see it being significantly more than that number at the end of the fiscal year, but I'm not going to take a guess. try to triangulate that exact number right now. Yeah, but thank Okay, great.
Speaker Change:
Speaker Change: Not every hospital has created equal so some hospitals are small in terms of their volume and some are very large in terms of the volume. So we get at one hospital will be worth 10, some in some cases.
Speaker Change: So.
Speaker Change: Obviously 45 is a great number.
Speaker Change: Certainly seeing it being significantly more than that number at the end of the fiscal year, but I'm going to I'm not going to kind of take a guess and try to triangulate that exact number right now, but thank you.
Yale Jen: And maybe just squeezing one more question to actually follow up the earlier one, that for the PMA applications, I know this is difficult to predict the time in possible approval, for a possible approval. But just let's assume, or maybe if in the normal, quote unquote, normal circumstances, would this process maybe take about 12 months to 16 months, or shorter? Just curious, what would be the sort of reference point we can at least think about?
Speaker Change: Okay, Great and maybe just squeezing one more question. So can you spell out the art is hernia, one that for the PMA applications.
Speaker Change: I know this is a.
Speaker Change: Difficult to predict the time possible approval for a possible approval, but let's assume or maybe you're seeing the normal quote unquote normal circumstances would just process and maybe take a lot of 12 months to 16 months or shorter.
Speaker Change: Just curious what we'll be doing so.
Speaker Change: Reference point looking at it.
Speaker Change: Stinker Paul.
Steve Lisi: So there are statistics that FDA puts out about PMAs, and this is a PMA supplement. So FDA puts statistics out about how long these things take, so you can see them online. I just caution you to take these averages because not every PMA is created equal. You know, we are just a supplement. You know, we basically make nitric oxide the same way with our second generation system as our first generation system. A lot of the things that we do are equivalent. It's obviously smaller, it obviously has some enhanced features, and it obviously is built to be used for transport in ambulances and helicopters and airplanes.
Speaker Change: Thanks.
Speaker Change: And so there there are statistics that FDA puts out about <unk> P. M. This is a PMA supplement.
Speaker Change: So after you put statistics out about how long these things take so you can see them online.
Speaker Change: I just caution you to take these averages because not every PMA is created equal.
Speaker Change: We are just to supplement.
Speaker Change: We basically make nitric oxide the same way as our with our second generation system is our first generation system.
Speaker Change: A lot of the things that we do are are equivalent.
Speaker Change: It's obviously smaller.
Speaker Change: It obviously has some some enhanced features.
Speaker Change: Obviously is built to be used for transporting the ambulances and helicopters and airplanes. So there are some differences but.
Steve Lisi: So there are some differences, but from how it operates, it's really not that much different. So, Could we be quicker than the average that FDA puts out? But again, if you look at FDA's guidelines, it's 180 days for a PMA supplement, and they normally do not hit that 180 days. And it's not that they can't hit their timelines. A lot of times they have questions, and that clock will stop while you're having discussions with FDA. So that's something that companies don't control, FDA does, and we're gonna work with them to get this done as quickly as possible.
Speaker Change: From how it operates its really not that much different.
Speaker Change: No.
Speaker Change: Could could we be quicker than the average that FDA puts out probably.
Speaker Change: But again, if you look at Fda's guidelines, it's 180 days.
Speaker Change: For a PMA supplement and they normally do not hit that 180 days and it's not that they can't hit their time lines a lot of times they have questions.
Speaker Change: And that clock will stop while youre, having discussions with FDA, So that's something that.
Speaker Change: Company has no control FDA does and we're going to work with them.
Speaker Change: To get this done as quickly as possible, but I just don't know.
Steve Lisi: But I just don't know what that timeline will be at this point.
Speaker Change: What what that timeline will be.
Steve Lisi: We'll have a better handle once we start discussions with FDA in the next couple of months.
Speaker Change: At this point, we'll have a better handle once we start discussions with FDA in the next couple of months.
Yale Jen: Great. That's a lot of great colors on the story. And again, congrats. And thanks for taking the question.
Speaker Change: Alright.
Speaker Change: A lot of great color on the story and again, congrats and thanks for taking the question.
Jason Bednar: Thanks, Jim. Our next question is from Jason Bednar with Piper. Hey guys, thanks for taking the question.
Speaker Change: Yeah.
Speaker Change: Our next question from Jason Bednar with Piper Sandler.
Speaker Change: Hey, guys. Thanks for taking the question. This is Joe <unk> on for Jason Congrats on the PMA submission.
Joe Downing: This is Joe Downing on for Jason. Congrats on the PMA submission. Just wondering if there's any difference you can call out in the sales process with the 2.0 device versus the 1.0 device. And then just off of that, do you just remind us how much this LungFit 2.0 expands the market? So Joe, thanks for the questions. I mean, we're not trying to sell this Gen 2 or market the Gen 2 right now. So we're not going to comment on how the process is different because we don't have a process yet. We have to wait for approval on that.
Speaker Change: Wondering if there's any difference you can call out in the sales process with the coupon no device versus the one point no device and then just off of that can you just remind us how much the lung for two point now expands the market.
Speaker Change: Yeah.
Speaker Change: So Joe Thanks for the questions I mean, we're not.
Speaker Change: Trying to sell this gen two where market the gen. Two right now so we're not going to comment on.
Speaker Change: How the process is different because we don't have a process yet we have to wait for approval on that but.
Steve Lisi: But as for how it opens the market, I mean, it vastly expands this market, it opens it up. for us as a company to every hospital in the world that wants to use nitric oxide. We can get it anywhere. Our Gen 1 is already in remote locations, treating patients. So the Gen 2, it'll be even easier to do that. So this is something that will change the way people use nitric oxide in the hospital. I think that it will increase volumes overall, and again, reach hospitals that don't use nitric right now. So this is for us, I think, and for the industry.
Speaker Change: But as for how it opens the market I mean, it it vastly expands this market it opens it up for.
Speaker Change: For us as a company to every hospital in the World.
Speaker Change: That wants to use of nitric oxide.
Speaker Change: We can get it anywhere our gen. One is already in remote locations treating patients. So the gen two it'll be even easier.
Speaker Change: To do that.
Speaker Change: So this is something that will will change the way people use of nitric oxide in the hospital.
Speaker Change: I think that it will increase volumes overall.
Speaker Change: And again reach hospitals that don't use nitric right now. So this is a for us I think and for the industry. It's a game changer. It really is.
Steve Lisi: It's a game changer. It really is.
Joe Downing: Great, thanks, Steve. Appreciate that.
Speaker Change: Great. Thanks, Steve I appreciate that and then just one last one on the competitive landscape.
Joe Downing: And then just one last one on the competitive landscape. Your largest peer put out a new offering a number of months ago. Just wondering if you're seeing anything worth calling out with contract negotiations and hospitals as a result of that launch.
Speaker Change: Your your largest peer.
Speaker Change: Put out a new offering.
Speaker Change: A number of months ago I'm, just wondering if youre seeing anything worth calling out with contract negotiations with hospitals as a result of that of that launch.
Steve Lisi: which which one are you talking about? Malin Krute. So they're of the Malin crowd offering. Yeah. you know, we haven't seen a change. I mean, the contracts are usually one, three and five years in this market. We haven't really seen any change in that. So at least my team and I haven't really seen much change. Yes, they're out there with their new offering and their marketing for sure. And I think last time they spoke, they gave an idea of how many hospitals they were in or something or that they were in hospitals. So you can take a look at what their transcript said.
Speaker Change: Which one are you talking about.
Speaker Change: Mallinckrodt.
Speaker Change: Oh, there of the Mallinckrodt offering.
Speaker Change: Yes.
Speaker Change: We haven't seen.
Speaker Change: A change I mean, the the contracts are usually one three and five years in this market, we haven't really seen any change in that.
Speaker Change: So at least my team and I haven't really seen much change, yes. They are out there with their new offering in there.
Speaker Change: They are marketing it for sure.
Speaker Change: Yes, I think they.
Speaker Change: The last time they spoke they gave an idea of how many hospitals they were in or something like that they were in hospital. So you can take a look at what their transcripts head.
Steve Lisi: So yeah, it's another competitor. It's another cylinder-based system out there. That's the fourth cylinder-based system in the United States.
Speaker Change: So yes, it's another competitor to another cylinder based system out there that's the fourth cylinder based system.
Speaker Change: In the United States.
Joe Downing: Great. Thanks, Steve. Appreciate it. Yep. Thanks, Joe. Goods Time.
Speaker Change: Great. Thanks, Steve I appreciate it.
Speaker Change: Yeah. Thanks, Joe.
Unknown Attendee: We are showing no further questions This does conclude our question.
Speaker Change: At this time, we're showing no further questions in queue. This does.
Speaker Change: Our question and answer session I would now like to turn the call back over to Steve Wilson for any closing remarks.
Steve Lisi: I would now like to turn the call back over to Steve Lisi for any closing Just like to thank everybody for joining us today, and we'll talk to you in August. Thank you.
Speaker Change: Just like to thank everybody for joining us today, and we'll talk to you in August Thank you.
Unknown Attendee: This concludes today's conference.
Speaker Change: This concludes today's conference you may disconnect your lines at this time. Thank you for your participation.
Unknown Attendee: You may disconnect your lines. Thank you for your