NASDAQ:MDAI Spectral AI Q1 2024 Earnings Report $1.26 -0.01 (-0.79%) As of 10:16 AM Eastern This is a fair market value price provided by Polygon.io. Learn more. Earnings HistoryForecast Spectral AI EPS ResultsActual EPS-$0.19Consensus EPS N/ABeat/MissN/AOne Year Ago EPSN/ASpectral AI Revenue ResultsActual Revenue$6.33 millionExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/ASpectral AI Announcement DetailsQuarterQ1 2024Date5/7/2024TimeN/AConference Call DateTuesday, May 7, 2024Conference Call Time5:00PM ETUpcoming EarningsSpectral AI's Q1 2025 earnings is scheduled for Tuesday, May 6, 2025Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Earnings HistoryCompany ProfilePowered by Spectral AI Q1 2024 Earnings Call TranscriptProvided by QuartrMay 7, 2024 ShareLink copied to clipboard.There are 8 speakers on the call. Operator00:00:00Good day, and welcome to the Spectro AI First Quarter 20 24 Financial Results Conference Call. All participants will be in listen only mode. Please note this event is being recorded. I would now like to turn the conference over to Devin Sullivan, Managing Director of The Equity Group. Please go ahead. Speaker 100:00:40Thank you, Chad. Good afternoon, everyone, and thank you for joining us for Spectral AI's 2024 Q1 financial results conference call. Our speakers for today will be Peter Carlson, Chief Executive Officer of Spectral AI and Vince Capone, the company's Chief Financial Officer. Before we begin, I'd like to remind everyone that during this call, certain statements may be made that constitute forward looking statements within the meaning of the Safe Harbor provisions of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the company's strategy, plans, objectives, initiatives and financial outlook. When used in these discussions, the words estimates, projected, expects, anticipates, forecasts, plans, intends, believes, seeks, may, will, should, future, propose and variations of those words or similar expressions or the negative versions of such words or expressions are intended to identify forward looking statements. Speaker 100:01:40These forward looking statements are not guarantees of future performance, conditions or results and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside the company's control and could cause actual results or outcomes to differ materially from those discussed in the forward looking statements. Investors are cautioned not to place undue reliance on these forward looking statements. Investors should carefully consider the foregoing factors and other risks and uncertainties described in the Risk Factors section of the company's filings with the SEC, including the registration statement and other documents filed by the company. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward looking statements. With that said, I'd now like to turn the call over to Pete Carlson, Spectral AI's Chief Executive Officer. Speaker 100:02:35Pete, please go ahead. Speaker 200:02:38Thank you, Devin, and good afternoon, everyone. We appreciate you joining us today for our Q1 financial results conference call. We had a strong start to the year with significant accomplishments in the areas of product advancement and deployment, clinical studies and executive appointments. We also strengthened our financial profile and created a well defined cash runway to support our growth initiatives. We are continuing to evolve from the clinical environment to commercialization and have a well defined business focus for 2024 and beyond. Speaker 200:03:14As previously announced, in February 2024, we received UKCA authorization to commence sales of DeepView AI burn in the UK. We are excited to share the deployment of Deepview systems at 3 UK hospitals: Royal Victoria Infirmary in Newcastle, Stoke Mandeville Hospital in Buckinghamshire, and Broomfield Hospital in Essex. 1st and foremost, we believe these deployments help professionals at these facilities provide more effective and more efficient care to patients. Additionally, having machines deployed increases clinician familiarity with the device, integrates our technology into the facility's workflow and provides real world data related to its usage and outcomes. We will deploy a total of 6 DeepU devices at locations across the UK this summer. Speaker 200:04:18After a period of customer evaluation, we expect to initiate commercial transactions in the second half of this year. While we do not expect these transactions to represent a significant contribution to revenues in 2024, we are pleased to begin commercial activities. Our clinical work to develop the DeepVue platform continues and let me share these updates. For burn, we are enrolling patients for a pivotal study at multiple burn centers and emergency departments across the U. S. Speaker 200:04:56The study is expected to enroll 240 patients, both adult and pediatric. As of today, we are approximately 20% towards our enrollment goal. This is expected to be the final clinical trial for burn before seeking FDA approval in 2025. For diabetic foot ulcers or DFUs, we are advancing our training and validation clinical studies in both the U. S. Speaker 200:05:25And the UK. To date, we have enrolled 470 patients across 14 total sites and anticipate completing enrollment at both studies this year. We are often asked about timing of cash flows from the contracts with BARDA, and I want to take a few minutes to summarize this critical partnership. Through March 31, 2024, we have received approximately $113,000,000 in cash payments from BARDA, most of which related to the burn 1 and burn 2 contracts that were completed in 2019 202023, respectively. This total includes approximately $11,000,000 under the first portion of the Project BioShield or PBS contract awarded in September 2023. Speaker 200:06:26The initial award of nearly $55,000,000 from the PBS contract will take us through the Q1 of 2026 in support of the clinical validation and FDA approval processes for the burn indication. The next award, which we expect to commence in the first half of twenty twenty six, is estimated to be $95,000,000 for procurement and deployment of devices to burn centers and select emergency departments across the U. S, along with funding several years of annual license fees for the devices deployed. Final amounts under this next award are subject to discussions with BARDA. In summary, to date, BARDA has awarded contracts to Spectral AI totaling $250,000,000 and since 2013 has paid $113,000,000 to the company under these contracts. Speaker 200:07:27Turning to updates on the continued strengthening of our leadership team and the Board. We welcome Jeremiah Sparks as Chief Commercial Officer beginning April 1, and I am pleased to say he hit the ground running, including joining our team in Chicago at the Annual Meeting of the American Burn Association. Jeremiah was an executive at Avita Medical prior to joining Spectral AI and brings more than 20 years of medical device marketing and business strategy, including experience in launching new products both nationally and globally. Prior to Aveda, Jeremiah worked at Johnson and Johnson, HealthPoint and Allergan. Additionally, we named Stan Mysik as Interim Chief Operating Officer on April 8, providing continuing leadership to our As disclosed in our proxy filing last month, we nominated Marion Snyder to our Board of Directors. Speaker 200:08:36Marion is a highly accomplished healthcare executive currently serving as Senior Director Corporate Accounts at Shockwave Medical, a medical device focused on the treatment of cardiovascular disease. Her prior experience is in both med device and pharmaceuticals with executive positions at MeMedx and Pfizer. My last update is about our newly formed healthcare intellectual property focused subsidiary, Spectral IP. We are fortunate to have a well known expert in intellectual property, Eric Spanenberg, as our largest shareholder. As you saw, we named Eric as CEO of this subsidiary and his primary focus will be identifying assets for this entity to acquire and exploring the potential spin off of Spectral IP to shareholders, providing additional value for our current investors. Speaker 200:09:33It is important to know that the activities of this IP focused subsidiary require limited management resources and no additional capital from the company. Additionally, no core operating assets of the company will be involved in the subsidiary. 4th, turning things over to Vince, I want to stress that we believe we are on the proper path to deliver reduced pain and suffering, faster and more appropriate treatment plans and reduced risk from complications for patients. Better information for treatment decisions by clinicians improved efficiencies and lower healthcare delivery costs for facilities, meaningful economic benefits for payers through objective and validated assessments and long term value for our shareholders. With that, I will have Vince Capone, our Chief Financial Officer, provide an update on our financial results. Speaker 200:10:35Vince? Thanks, Pete. Thank you Speaker 300:10:38all for joining us today. We issued our press release this afternoon, which contains additional detail of our operating results, and we are filing our 10 Q with the SEC today as well. With that in mind, I will focus my remarks on select highlights and key items. We are pleased to report that research and development revenue for the Q1 rose 24.6% to $6,300,000 from $5,100,000 in the Q1 of last year. This growth reflects an increased level of activity under the BARDA project Bio Shield contract, which was awarded to the company in September 2023. Speaker 300:11:19Gross margin also improved rising to 46.6% from 42.9% in the Q1 of last year due to the higher reimbursement rate under the BARDA BioShield contract as compared to the reimbursement rate in the BARDA burn 2 contract under which we operated in last year's Q1. General and administrative expenses in the Q1 were flat at $5,100,000 Non revenue generating research and development activities decreased by approximately $100,000 for the 3 months ended March 31, 2024, compared to the Q1 of 2023 and that's offset by an increase of approximately $100,000 related to other administrative expenses for the 3 months ended March 31, 2024 as compared to the Q1 of 2023. Other expenses for the Q1 of 2024 were up approximately $500,000 from the Q1 of 2023 and reflected borrowing related costs of $300,000 and transaction costs of $1,000,000 each related to the company's previously announced financing arrangements. We trimmed our net loss for the quarter to $3,200,000 or $0.19 per share as compared to a net loss of $3,600,000 or $0.27 per share last year. At March 31, 2024, we had 17,482,333 shares outstanding. Speaker 300:13:00Moving to the balance sheet. As of March 31, 2024, cash and cash equivalents totaled $10,200,000 up from $4,800,000 at year end. We enhanced our access to capital by completing a common stock purchase agreement with an investment bank under which the company netted $2,700,000 The company still has the ability to draw down an additional 3,000,000 dollars under this facility. In addition, we entered into a standby equity purchase agreement with a long only investor that includes $12,500,000 of prepaid advances. As of March 31, 2024, the company received $4,600,000 net from the Standby Equity Purchase Agreement and the company anticipates receiving $5,000,000 shortly after our May 14, 2024 Annual Meeting and the final advance of $2,500,000 60 days thereafter. Speaker 300:14:07As a reminder, any drawdowns above the prepaid advances of $12,500,000 is solely at the discretion of the company. For 2024, we are reaffirming our revenue guidance of approximately $28,000,000 an expected increase of 55 percent from the $18,100,000 we reported in 2023. This growth reflects our work on the BARDA project BioShield contract with additional contributions from the ongoing handheld contract. As a reminder, we recently announced a new contract with the Defense Health Agency that provides significant additional support for the development of the handheld version of our DeepView system device valued at over $500,000 bringing the total for the development of this device to greater than $6,000,000 This guidance does not include contributions from sales of the D. F. Speaker 300:15:10U. System for burn in the UK in the second half of twenty twenty four, which is not expected to be material. Thank you for your time. And with that, I Speaker 200:15:21will turn the conversation back over to Pete. Thank you, Vince. We are pleased with our progress in the Q1 as we welcome both Jeremiah and Stan to our leadership team and strengthened our financial position. I want to thank our entire team for their dedication and commitment to our promise to develop and commercialize our DeepView system. Their achievements to date and those in the horizon drive our success. Speaker 200:15:51Chad, let's open the call for questions. Operator00:15:54Thank you. We will now begin the question and answer session. And the first question will be from Ryan Zimmerman from BTIG. Please go ahead. Speaker 400:16:21Hi, Pete Vince. This is Izzy on for Ryan. Thanks for taking the questions and congrats on the progress so far. So just to start out, it's great to see that you guys have these initial placements in the UK. And I was wondering if you could provide any feedback on what guys are hearing from those initial placements, just qualitatively what are surgeons thinking about the system? Speaker 200:16:42Thanks, Susie. Good to talk to you. We've had positive reactions from the field. Surgeons are excited about the opportunity to use the tool. The interesting aspect is in the UK with the single payer system, they are very focused as on the quality of care and the economics are just so different than here in the U. Speaker 200:17:10S. So as we've talked to them and as we hit and receive this feedback, it is all about the improving quality of care. They find the device easy to use. In easy to use, it is usable by all people in the clinics. So nurse practitioners, nurses are able to do to take these images and get the diagnosis back from the device, which essentially gives them the ability to get that critical diagnosis regardless of how skilled they are on assessing a burn. Speaker 200:17:48So the facilities enjoy the consistency and the quality of the assessment that happens by using the device. Speaker 400:18:00Good. That's helpful to hear. And next on the U. S. Burn trial, I heard you guys say that enrollment is up to 20%, which is great to see. Speaker 400:18:08We've heard some commentary from others in the industry saying that incidents of burns were down in the Q1 for the U. S. So I was just wondering if you guys have seen any impact in terms of the pace Speaker 200:18:27We hear the same industry analysis and updates. For us, the other aspect is we were just getting going in the quarter. But yes, we did see that there were fewer burns. There is some seasonality to burns, some holiday weekends and things like that can be indications of it. One of the things we've seen is unfortunately a greater concentration of burns in pediatrics. Speaker 200:18:56So we're that's gone quicker than we anticipated. But I do think your assessment is correct that the burn incidence rate was lower in the Q1 and we would expect it to be higher here in the second summer months in the U. S. Speaker 400:19:14Got it. And then last one for me before I jump back in queue. Your BARDA revenue for the quarter came in just a little bit shy of our estimates. So given you guys are still expecting to see that $28,000,000 for the full year, I was just wondering if you could provide some commentary around how you're thinking about the cadence of revenue for the rest of the year? Thanks for taking the question. Speaker 200:19:33Thanks, Susie, again. One of the drivers of the revenue is enrollment in the trial. That is a specific trigger for the billings. And so the ramp up period in the Q1 was, as I said, just a touch slower than what we had anticipated. We're very pleased with where we are to date and the current momentum. Speaker 200:19:54That being said, we do think the revenue would be a little bit back ended to the second half of the year. So as you think about the next quarter, I think we would see a slight somewhat of an increase, but it may not get up to that pro rata amount for the remaining three quarters and we think the second half would so maybe there's more than half of the revenue is in the second half of the year. Operator00:20:27Thank you. And the next question will come from RK Ramakanth from H. C. Wainwright. Please go ahead. Speaker 500:20:35Thank you. This is RK from HCW. Good afternoon, Pete. So continuing on some of the thoughts on the clinical trials, so the DFU training study that got completed and also you plan to get the validation study completed in the second half. So what 2 things. Speaker 500:21:04One is what sort of data should we expect from these 2 studies? And 2, the data that comes out of these two studies, is that enough for any filings? Or you take these data and try to plan for a pivotal studies, so that you can use that to file with the FDA? Speaker 200:21:32Okay. I appreciate the question. It's good to talk. A couple of different things here. The training study well, the work we've done to date kind of combined, the information we've done to date, we think provides us the data needed to prepare a submission for the UK. Speaker 200:21:51So we're on track for that. It's probably a couple of months, 2, 3 months away as we synthesize that data and prepare the submission. But we do have enough data in hand to begin our preparation of that submission in the UK. It is completion of the validation study that would be the information we believe we will need for a U. S. Speaker 200:22:23Submission. So again, that's something we look to complete this year and thus would be in a position to begin preparing that submission end of this year, early next year from for the diabetic foot ulcer. What I will say is, as we think about burn and diabetic foot ulcer, we very well may end up in a spot where we think burn is the better first submission to the FDA. We're going for a de novo application here and we have 10 plus years of data on burn. And so that's our strong point to leverage the 1st Triple Crown race here in the S. Speaker 200:23:14You ride your good horse in. And so I think we're considering the order, but separately, the data would be there and the information needed for also the diabetic foot ulcer submission. And we'll work with the FDA on kind of timing of all of this. Speaker 500:23:34Very good. Thanks. And then I'm assuming from what you just said, the 76 patient study that is being conducted in Ireland, That also kind of plugs into what you're just talking about, the study that's going on in the U. S. Is that how we should think about it? Speaker 500:23:59And the other question is, at a later point, once you get through the burn indication in the U. S, can you take some of this data and use it for U. S? Or do you need to kind of do separate studies? Speaker 200:24:20We can use the data from the UK for activities in the U. S. Associated with reimbursement and procurement, so with payers and with buyers. The FDA does look for us to have U. S. Speaker 200:24:37Data. And again, we think we have a robust set of the training data. We have more work to do on the validation side to meet what we think is the threshold here in the U. S. With U. Speaker 200:24:51S. Specific data. The way to think about that work in the U. K. Is it's a subset of the overall study, but it does give us a concentrated group on which to think about, assess and maybe potentially do some publications. Speaker 500:25:11Okay. Now that you have Jeremiah on board, so I'm sure he's kind of tasked with kind of watching the deployment in the U. K. And as you stated, U. K. Speaker 500:25:24Is kind of weird in terms of reimbursement because you only have one entity to work with. But what sort of learnings would Jaramillo be looking from that experience? Because once we come back on to this side of the pond, things are quite different, both in terms of commercialization and also in terms of reimbursement? Speaker 200:25:52Yes. So there's several aspects of it, a couple of which were in my prepared remarks. It's how clinicians and facilities are using the device. It's capturing the real world data. It also is a start to commercial transactions. Speaker 200:26:10And so understanding the ebb and flow or puts and takes of entering into commercial transactions with facilities and caregivers. And that certainly is a good help for us. Anytime you can begin commercial, get through terms and conditions, get financial terms in place, All of those are very helpful input into our strategy here in the U. S. And we do look to leverage the continuing real world data we receive in the UK for payers and for facilities as we have those conversations. Speaker 200:26:49We think that will be very useful, while also FDA discussions. Speaker 500:27:00Okay. One last question for me. Speaker 200:27:03BARDA is Speaker 500:27:03a huge force behind you behind the company, which is excellent. So I'm trying to understand where all BARDA can actually help you or is it part of the plan in terms of how much they can help you in terms of not only regulatory process, but also in the commercial process, certainly in the regulatory process. Are they anyway involved in trying to make sure that you run your studies in such a way that you can get the product approved? Of course, for BARDA, they don't care about the FDA approval. They can still take the product as long as they're comfortable with the data and the utility of the product. Speaker 500:27:48But I'm just trying to understand what sort of help are you getting in terms of the regulatory process in the U. S? Speaker 200:27:58Arndt is a great partner. We very much enjoy working with them. We think our interaction with them has created a good discipline inside our company for interacting with a federal agency. So we think we're well prepared for interactions with the FDA. BARDA certainly is holding us to standards that they think are appropriate for the clinical trials. Speaker 200:28:28And I do believe that's informed by their experience with other companies working with the FDA. They do have a working relationship. I think it's formalized somewhat in a document between the two groups. But so we like the advice we receive from BARDA relative to the clinical trial work. They've been informative on, for instance, wanting the specific participation of the pediatrics. Speaker 200:29:06They're focused on having the device in both the burn centers and the emergency departments. And those things, we think those are to not only support BARDA's mission, but are good for approval by the FDA. And then as far as deployment, we think of BARDA as a bit of a distribution channel, in that they are funding, but also supporting and encouraging users' facilities to take the device on. So there'll be some number of facilities covered within this next round or option of the Project BioShield contract. And then we'll work together with BARDA on further penetration across emergency departments in the U. Speaker 200:29:54S. Speaker 500:29:57Perfect. Thank you very much, Pete, for taking all my questions. I appreciate it. I'm looking forward to Speaker 200:30:04continued discussions. Thank you, RK. Operator00:30:09And the next question will be from John Vandermosten from Zacks. Please go ahead. Speaker 600:30:16Great. Thank you and hello and good afternoon Pete and Vince. I've been going down the rabbit hole of how providers are diagnosing DFU and burn and triaging and things like that. And are we aware of how the factors that the AI systems consider when making a diagnosis and how that relates to how the system and the provider would do that? Any correlation there between those 2 that you've been able to tease out? Speaker 200:30:53I don't know that I'd say there's been a correlation we've been able to tease out as we're still in our early days of working with the payers here in the U. S. Obviously, the care setting matters, just even the difference between a burn center and an emergency department is going to be important on reimbursements. Those are 2 different reimbursement schemes, if you will, or approaches. What we believe this tool device does is better informs existing, diagnoses. Speaker 200:31:32So the process is still going to be the same, I think, for once you get into the caregiving. What we're doing, what this device will do is allow practitioners to be better informed in a couple of ways, just a more consistent we think and certainly as you get away from experts into the emergency departments are better informed assessment of viability of the skin as well as some pretty specific measurements of where the viability, non viability edge is. So how much of a burn, for instance, needs to be addressed through skin grafts or something else versus doesn't. And what's important there is the more precise you can be there, the less impact you have to the patient. Generally, these skin grafts are autologous. Speaker 200:32:29So the less impact you have to the patient somewhere else in their body at what is already a traumatic time. Speaker 600:32:37Okay. And it's been my sense, AI, we're still kind of the early days of approval for AI ML type products. And my sense has been that regulatory authorities and payers, they kind of want to know how it works and what it's looking at. I mean, do you have that same sense as well? Or are they just looking for kind of the end result, looking at those high percentage of accurate assessment? Speaker 200:33:03I think they very much want to understand what is going on. And the thing that's important for people to understand about our devices, This is a closed loop AI. It is not an iterative AI. So it does not have some of the risks and concerns you have with different approach to AI such as some of these chat bots or things like that. Said a different way, our artificial intelligence tool is running an algorithm against a closed database and it is making a instantaneous assessment considering millions and millions of data points within that database. Speaker 200:33:53And that's what the power of the algorithm is. So this is helping practitioners see what the human eye cannot see. But again, it's within a closed, I'll call it closed loop. I don't think that's the most technical term. But within a finite amount of data and there is not iterative learning where the device starts going different ways. Speaker 200:34:20There is iterative learning from adding additional data into the database, but it is still a closed environment. Okay. Speaker 600:34:29Yes. Speaker 200:34:29That being said, I do think to your point, the regulators very much want to understand what is going on. And it's even where there's really an approval process needed per indication because they want to understand as we understand it now, they want to know what's going on with each data set and each indication. Okay. Speaker 600:34:57And I wanted to also ask about the how sales will go forward. As I understand it, there are BARDA sales and then there are non BARDA sales in the U. S. Related to burn. Maybe you can explain that just so I understand a little bit better. Speaker 600:35:14I assume that there's probably certain hospitals that they would target first and then you could expand out from there to other locations that might also be appropriate candidates for buying. Is that how it works Or is there another methodology that you expect to apply when it's approved and ready to be deployed and sold? Speaker 200:35:36You are generally on point, John. What I would say is it's a partnership working together with them. Yes, this next phase, next option of the PBS contract has revenue that you would think of as a commercial sale because it would be for deployment of a device and for annual license fees. We will work together with BARDA on what centers and which emergency departments the devices would go. So they will have a significant say in where we get the 1st wave and the sites for which they're paying. Speaker 200:36:20But again, the goal is to get this have this penetrate across the 5,000 emergency departments in the U. S. In a significant way. That's what BARDA wants us to do. And we'll be working with them even if it's not through a direct funding situation. Speaker 200:36:37We will be working with them to strategize on the priority locations and to leverage their contacts in those locations. And we sort of have a warm lead across the emergency department population is the way we think about it. Speaker 600:36:55Okay. And would you sell all of the there may be some capacity constraints. Would you sell all the incremental units to the BARDA contract targets first and then go to the other ones that aren't included as part of the contract? Or would you kind of do them in parallel? I mean, there could be, I guess, capacity constraints that might limit you to do that. Speaker 600:37:19What is your sense on how that might play out? Speaker 200:37:23We don't see any capacity constraints relative to getting these devices out. We think we can work with our what we know we can work with our manufacturing partner to produce the devices needed to not only distribute to the locations anticipated within the BARDA contract, but to others. I do think it would be something somewhat relatively parallel, Whether there's a lead time where we work exclusively within the BARDA deployment for a quarter or 2. But overall, I think it would be a parallel process. Speaker 600:38:01Okay. And last one for me is on the IP subsidiary. I think you alluded a little bit to this in the call that there wouldn't be any cash, I guess, exchanging hands. So will that entity, I guess, raise cash separately after it spun off? Or will they allocate any cash to you maybe in terms of debt or something like that? Speaker 600:38:20I just was wondering how the cash flow might work between the 2 entities when it spins off? Speaker 200:38:27Yes. So we're being we don't anticipate any cash flow between the 2 entities. It is looking to be self funding. I mean, it's demonstrated that through $1,000,000 funding from an affiliate of Eric's, our large shareholder. And as part of the work he will do as CEO is he would also secure additional funding for the activities of that subsidiary. Speaker 200:38:50That would be separate and different sources than we would go to for capital for our organization. And no, we don't see that there would be cash flow going between the two entities. Speaker 600:39:01Got it. All right. Thank you, Pete. Speaker 200:39:03Thanks, John. Good to talk. Operator00:39:10The next question is from Christopher Ricoso from Partner Cap Group. Please go ahead. Speaker 700:39:18Good afternoon, Peter and Vincent. I have a couple of, I think, brief questions. The first one, apart from the efforts that you've obviously made in the United States and the UK, can you comment on any efforts in other regions of the world? I know that you've done you've spent a fair amount of time in the Middle East. If you could characterize how those efforts are going and any timing in terms of potential yields, so to speak, on those efforts? Speaker 700:39:50Also, I know that you've given guidance for full year 2024. Is it possible to look out beyond that? And if not, citing nominal numbers at least, what your aspiration is in terms of comp and annual growth rates over the next few years in terms of your revenues? Speaker 200:40:14Christopher, good to talk. Thanks for the questions. You got a couple of different ones in there. First, as far as geographies, we are focused on the U. S. Speaker 200:40:23And the U. K. Primarily here. That being said, we do have interactions going on in the Gulf Council countries. I don't know that I'd characterize it a significant amount of time, but we have interacted with parties there. Speaker 200:40:41We have attended some conferences. And we do think that's a situation where there's an opportunity to get some devices in the field and begin some testing and understand what the market opportunity might be. That environment, the Gulf Council countries generally will look to a UK approval like this CA mark that we have for the regulatory. So it sort of removes one burden. And obviously, you're dealing with a totally different regulatory environment in that and particularly say in Saudi Arabia, where it can be almost an individual decision maker that can make some things happen as far as allowing the device in the region. Speaker 200:41:25Whatever we did would be putting the toe in the water, I would say, to start testing and trials and understand the interest and things of that nature. And there are other markets that we would look at a little bit, but our primary focus is going to be here in the U. S. And the UK. Another one you would hear us talk about seeking approval would be in Mainland Europe. Speaker 200:41:51That's the CE Mark. That's a longer process than what the UK process was. And then you also have to go a little bit country by country after that. So we want to do that, but we want to really focus on meeting the timelines we've established here in the U. S. Speaker 200:42:09And the UK. Secondly, now I'm going to forget what your other part of your question, didn't write it down. The other part of the Speaker 700:42:19question was, I know that you Speaker 200:42:22go by. Growth rates. Yes, growth rates. Sorry. Speaker 500:42:24Yes. Speaker 200:42:25I would not think about it as compounded growth rates right now because the nature of our revenue is going to shift. What we've talked about is $28,000,000 for 2024 and that's our R and D revenue. I would remind you what I talked about regarding this first part of the Project BioShield contract that has a value total of $55,000,000 and runs through the first quarter of 2026. So you can probably do some math and figure out order of magnitude of 20.25 revenues from that. And then the $95,000,000 would be reflected over several years as well as we would about that would be parallel to our activity under the BARDA Project BioShield contract. Speaker 200:43:28So it's not necessarily it's such chunky and almost contract driven revenue that I wouldn't necessarily talk about growth rates, But there will be some growth in that. It's not that there's not growth, but it's just not a recurring item on which to base the number. We'll have this first phase R and D revenue for the Q1 of 2026 And then we'll have some commercial revenue beginning that will grow. And so you would see compounding there. And then we would have new commercial revenue coming in, in the U. Speaker 200:44:05S. For burn or in the U. S. For DFU, and then the UK for DFU. So multiple types of revenue coming in and it's not until we get into the commercial transactions that you really would look at something on which it would be appropriate to start building growth rates. Speaker 700:44:24I see. And one more brief question, if I may, in terms of this spin off announcement that you gentlemen made. Should I be conceptualizing this as almost like a holdcoopco structure or somewhat of a true subsidiary of if you think about it Operator00:44:45from a Speaker 700:44:46schematic perspective, is it essentially like a sidebar subsidiary where MDAI holds an either significant minority or majority stake in it? Speaker 200:45:01It would be a brother sister type arrangement within an org chart. So no, it's not a holdcoopco. Spectral AI is the holding company. SpectralMD is our U. S. Speaker 200:45:12Operating company. There's a U. K. Company in the U. S. Speaker 200:45:17And then there is a spectral IP. So, they're all that one teardown from the holding company. Speaker 700:45:25Okay. Thank you. Thank you. Operator00:45:28And ladies and gentlemen, this concludes today's question and answer session. I would like to turn the conference back over to Pete Carlson for any closing remarks. Speaker 200:45:38Thank you, Chad, and thank you, everyone, for your participation and continued interest in spectral AI. We're very pleased with the progress we continue to make and remain optimistic about our prospects for growth. We hope to speak with some of you at upcoming events, including the Sidoti MicroCap Virtual Conference on May 8th 9th later this week, at our Annual Meeting of Shareholders next week on May 14th, at the Northland Virtual Growth Conference in late June and various other investor conferences that we will announce throughout the year. Thank you and have a good evening. Operator00:46:16Thank you, sir. The conference has now concluded. Thank you for joining today's presentation. You may now disconnect.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallSpectral AI Q1 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K) Spectral AI Earnings HeadlinesBurn clinicians present positive findings of the DeepView® System’s accuracy at the American Burn Association annual meetingApril 30, 2025 | finance.yahoo.comBurn clinicians present positive findings of the DeepView® System's accuracy at the American Burn Association annual meetingApril 30, 2025 | globenewswire.comURGENT: Someone's Moving Gold Out of London...People who don’t understand the gold market are about to lose a lot of money. Unfortunately, most so-called “gold analysts” have it all wrong… They tell you to invest in gold ETFs - because the popular mining ETFs will someday catch fire and close the price gap with spot gold. May 5, 2025 | Golden Portfolio (Ad)Spectral AI files to sell 2.84M shares of common stock for holdersApril 26, 2025 | markets.businessinsider.comGlobal AI Diagnostics Market to Reach $8.54 Billion By 2033 as Industry Sees Increasing R&D and Strategic CollaborationsApril 16, 2025 | markets.businessinsider.comSpectral AI (MDAI) Secures $17.7 Million to Launch Burn Wound AI SystemApril 1, 2025 | msn.comSee More Spectral AI Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Spectral AI? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Spectral AI and other key companies, straight to your email. Email Address About Spectral AISpectral AI (NASDAQ:MDAI), an artificial intelligence (AI) company, focuses on developing predictive medical diagnostics in the United States. The company develops medical diagnostics for faster and accurate treatment decisions in wound care with applications involving patients with burns and diabetic foot ulcers. Its products include DeepView System, a predictive analytics platform integrated with the predictive AI-Burn, which combines AI algorithms and multispectral imaging (MSI) imaging for an assessment of wound healing potential and offers clinicians an objective and immediate assessment of a wound's healing potential prior to treatment or other medical intervention; and DeepView SnapShot M, a handheld, portable, and wireless diagnostic tool, that provides a potential enhanced and expanded use for the government and emergency care, first responders, and potentially home health care professionals. 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There are 8 speakers on the call. Operator00:00:00Good day, and welcome to the Spectro AI First Quarter 20 24 Financial Results Conference Call. All participants will be in listen only mode. Please note this event is being recorded. I would now like to turn the conference over to Devin Sullivan, Managing Director of The Equity Group. Please go ahead. Speaker 100:00:40Thank you, Chad. Good afternoon, everyone, and thank you for joining us for Spectral AI's 2024 Q1 financial results conference call. Our speakers for today will be Peter Carlson, Chief Executive Officer of Spectral AI and Vince Capone, the company's Chief Financial Officer. Before we begin, I'd like to remind everyone that during this call, certain statements may be made that constitute forward looking statements within the meaning of the Safe Harbor provisions of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the company's strategy, plans, objectives, initiatives and financial outlook. When used in these discussions, the words estimates, projected, expects, anticipates, forecasts, plans, intends, believes, seeks, may, will, should, future, propose and variations of those words or similar expressions or the negative versions of such words or expressions are intended to identify forward looking statements. Speaker 100:01:40These forward looking statements are not guarantees of future performance, conditions or results and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside the company's control and could cause actual results or outcomes to differ materially from those discussed in the forward looking statements. Investors are cautioned not to place undue reliance on these forward looking statements. Investors should carefully consider the foregoing factors and other risks and uncertainties described in the Risk Factors section of the company's filings with the SEC, including the registration statement and other documents filed by the company. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward looking statements. With that said, I'd now like to turn the call over to Pete Carlson, Spectral AI's Chief Executive Officer. Speaker 100:02:35Pete, please go ahead. Speaker 200:02:38Thank you, Devin, and good afternoon, everyone. We appreciate you joining us today for our Q1 financial results conference call. We had a strong start to the year with significant accomplishments in the areas of product advancement and deployment, clinical studies and executive appointments. We also strengthened our financial profile and created a well defined cash runway to support our growth initiatives. We are continuing to evolve from the clinical environment to commercialization and have a well defined business focus for 2024 and beyond. Speaker 200:03:14As previously announced, in February 2024, we received UKCA authorization to commence sales of DeepView AI burn in the UK. We are excited to share the deployment of Deepview systems at 3 UK hospitals: Royal Victoria Infirmary in Newcastle, Stoke Mandeville Hospital in Buckinghamshire, and Broomfield Hospital in Essex. 1st and foremost, we believe these deployments help professionals at these facilities provide more effective and more efficient care to patients. Additionally, having machines deployed increases clinician familiarity with the device, integrates our technology into the facility's workflow and provides real world data related to its usage and outcomes. We will deploy a total of 6 DeepU devices at locations across the UK this summer. Speaker 200:04:18After a period of customer evaluation, we expect to initiate commercial transactions in the second half of this year. While we do not expect these transactions to represent a significant contribution to revenues in 2024, we are pleased to begin commercial activities. Our clinical work to develop the DeepVue platform continues and let me share these updates. For burn, we are enrolling patients for a pivotal study at multiple burn centers and emergency departments across the U. S. Speaker 200:04:56The study is expected to enroll 240 patients, both adult and pediatric. As of today, we are approximately 20% towards our enrollment goal. This is expected to be the final clinical trial for burn before seeking FDA approval in 2025. For diabetic foot ulcers or DFUs, we are advancing our training and validation clinical studies in both the U. S. Speaker 200:05:25And the UK. To date, we have enrolled 470 patients across 14 total sites and anticipate completing enrollment at both studies this year. We are often asked about timing of cash flows from the contracts with BARDA, and I want to take a few minutes to summarize this critical partnership. Through March 31, 2024, we have received approximately $113,000,000 in cash payments from BARDA, most of which related to the burn 1 and burn 2 contracts that were completed in 2019 202023, respectively. This total includes approximately $11,000,000 under the first portion of the Project BioShield or PBS contract awarded in September 2023. Speaker 200:06:26The initial award of nearly $55,000,000 from the PBS contract will take us through the Q1 of 2026 in support of the clinical validation and FDA approval processes for the burn indication. The next award, which we expect to commence in the first half of twenty twenty six, is estimated to be $95,000,000 for procurement and deployment of devices to burn centers and select emergency departments across the U. S, along with funding several years of annual license fees for the devices deployed. Final amounts under this next award are subject to discussions with BARDA. In summary, to date, BARDA has awarded contracts to Spectral AI totaling $250,000,000 and since 2013 has paid $113,000,000 to the company under these contracts. Speaker 200:07:27Turning to updates on the continued strengthening of our leadership team and the Board. We welcome Jeremiah Sparks as Chief Commercial Officer beginning April 1, and I am pleased to say he hit the ground running, including joining our team in Chicago at the Annual Meeting of the American Burn Association. Jeremiah was an executive at Avita Medical prior to joining Spectral AI and brings more than 20 years of medical device marketing and business strategy, including experience in launching new products both nationally and globally. Prior to Aveda, Jeremiah worked at Johnson and Johnson, HealthPoint and Allergan. Additionally, we named Stan Mysik as Interim Chief Operating Officer on April 8, providing continuing leadership to our As disclosed in our proxy filing last month, we nominated Marion Snyder to our Board of Directors. Speaker 200:08:36Marion is a highly accomplished healthcare executive currently serving as Senior Director Corporate Accounts at Shockwave Medical, a medical device focused on the treatment of cardiovascular disease. Her prior experience is in both med device and pharmaceuticals with executive positions at MeMedx and Pfizer. My last update is about our newly formed healthcare intellectual property focused subsidiary, Spectral IP. We are fortunate to have a well known expert in intellectual property, Eric Spanenberg, as our largest shareholder. As you saw, we named Eric as CEO of this subsidiary and his primary focus will be identifying assets for this entity to acquire and exploring the potential spin off of Spectral IP to shareholders, providing additional value for our current investors. Speaker 200:09:33It is important to know that the activities of this IP focused subsidiary require limited management resources and no additional capital from the company. Additionally, no core operating assets of the company will be involved in the subsidiary. 4th, turning things over to Vince, I want to stress that we believe we are on the proper path to deliver reduced pain and suffering, faster and more appropriate treatment plans and reduced risk from complications for patients. Better information for treatment decisions by clinicians improved efficiencies and lower healthcare delivery costs for facilities, meaningful economic benefits for payers through objective and validated assessments and long term value for our shareholders. With that, I will have Vince Capone, our Chief Financial Officer, provide an update on our financial results. Speaker 200:10:35Vince? Thanks, Pete. Thank you Speaker 300:10:38all for joining us today. We issued our press release this afternoon, which contains additional detail of our operating results, and we are filing our 10 Q with the SEC today as well. With that in mind, I will focus my remarks on select highlights and key items. We are pleased to report that research and development revenue for the Q1 rose 24.6% to $6,300,000 from $5,100,000 in the Q1 of last year. This growth reflects an increased level of activity under the BARDA project Bio Shield contract, which was awarded to the company in September 2023. Speaker 300:11:19Gross margin also improved rising to 46.6% from 42.9% in the Q1 of last year due to the higher reimbursement rate under the BARDA BioShield contract as compared to the reimbursement rate in the BARDA burn 2 contract under which we operated in last year's Q1. General and administrative expenses in the Q1 were flat at $5,100,000 Non revenue generating research and development activities decreased by approximately $100,000 for the 3 months ended March 31, 2024, compared to the Q1 of 2023 and that's offset by an increase of approximately $100,000 related to other administrative expenses for the 3 months ended March 31, 2024 as compared to the Q1 of 2023. Other expenses for the Q1 of 2024 were up approximately $500,000 from the Q1 of 2023 and reflected borrowing related costs of $300,000 and transaction costs of $1,000,000 each related to the company's previously announced financing arrangements. We trimmed our net loss for the quarter to $3,200,000 or $0.19 per share as compared to a net loss of $3,600,000 or $0.27 per share last year. At March 31, 2024, we had 17,482,333 shares outstanding. Speaker 300:13:00Moving to the balance sheet. As of March 31, 2024, cash and cash equivalents totaled $10,200,000 up from $4,800,000 at year end. We enhanced our access to capital by completing a common stock purchase agreement with an investment bank under which the company netted $2,700,000 The company still has the ability to draw down an additional 3,000,000 dollars under this facility. In addition, we entered into a standby equity purchase agreement with a long only investor that includes $12,500,000 of prepaid advances. As of March 31, 2024, the company received $4,600,000 net from the Standby Equity Purchase Agreement and the company anticipates receiving $5,000,000 shortly after our May 14, 2024 Annual Meeting and the final advance of $2,500,000 60 days thereafter. Speaker 300:14:07As a reminder, any drawdowns above the prepaid advances of $12,500,000 is solely at the discretion of the company. For 2024, we are reaffirming our revenue guidance of approximately $28,000,000 an expected increase of 55 percent from the $18,100,000 we reported in 2023. This growth reflects our work on the BARDA project BioShield contract with additional contributions from the ongoing handheld contract. As a reminder, we recently announced a new contract with the Defense Health Agency that provides significant additional support for the development of the handheld version of our DeepView system device valued at over $500,000 bringing the total for the development of this device to greater than $6,000,000 This guidance does not include contributions from sales of the D. F. Speaker 300:15:10U. System for burn in the UK in the second half of twenty twenty four, which is not expected to be material. Thank you for your time. And with that, I Speaker 200:15:21will turn the conversation back over to Pete. Thank you, Vince. We are pleased with our progress in the Q1 as we welcome both Jeremiah and Stan to our leadership team and strengthened our financial position. I want to thank our entire team for their dedication and commitment to our promise to develop and commercialize our DeepView system. Their achievements to date and those in the horizon drive our success. Speaker 200:15:51Chad, let's open the call for questions. Operator00:15:54Thank you. We will now begin the question and answer session. And the first question will be from Ryan Zimmerman from BTIG. Please go ahead. Speaker 400:16:21Hi, Pete Vince. This is Izzy on for Ryan. Thanks for taking the questions and congrats on the progress so far. So just to start out, it's great to see that you guys have these initial placements in the UK. And I was wondering if you could provide any feedback on what guys are hearing from those initial placements, just qualitatively what are surgeons thinking about the system? Speaker 200:16:42Thanks, Susie. Good to talk to you. We've had positive reactions from the field. Surgeons are excited about the opportunity to use the tool. The interesting aspect is in the UK with the single payer system, they are very focused as on the quality of care and the economics are just so different than here in the U. Speaker 200:17:10S. So as we've talked to them and as we hit and receive this feedback, it is all about the improving quality of care. They find the device easy to use. In easy to use, it is usable by all people in the clinics. So nurse practitioners, nurses are able to do to take these images and get the diagnosis back from the device, which essentially gives them the ability to get that critical diagnosis regardless of how skilled they are on assessing a burn. Speaker 200:17:48So the facilities enjoy the consistency and the quality of the assessment that happens by using the device. Speaker 400:18:00Good. That's helpful to hear. And next on the U. S. Burn trial, I heard you guys say that enrollment is up to 20%, which is great to see. Speaker 400:18:08We've heard some commentary from others in the industry saying that incidents of burns were down in the Q1 for the U. S. So I was just wondering if you guys have seen any impact in terms of the pace Speaker 200:18:27We hear the same industry analysis and updates. For us, the other aspect is we were just getting going in the quarter. But yes, we did see that there were fewer burns. There is some seasonality to burns, some holiday weekends and things like that can be indications of it. One of the things we've seen is unfortunately a greater concentration of burns in pediatrics. Speaker 200:18:56So we're that's gone quicker than we anticipated. But I do think your assessment is correct that the burn incidence rate was lower in the Q1 and we would expect it to be higher here in the second summer months in the U. S. Speaker 400:19:14Got it. And then last one for me before I jump back in queue. Your BARDA revenue for the quarter came in just a little bit shy of our estimates. So given you guys are still expecting to see that $28,000,000 for the full year, I was just wondering if you could provide some commentary around how you're thinking about the cadence of revenue for the rest of the year? Thanks for taking the question. Speaker 200:19:33Thanks, Susie, again. One of the drivers of the revenue is enrollment in the trial. That is a specific trigger for the billings. And so the ramp up period in the Q1 was, as I said, just a touch slower than what we had anticipated. We're very pleased with where we are to date and the current momentum. Speaker 200:19:54That being said, we do think the revenue would be a little bit back ended to the second half of the year. So as you think about the next quarter, I think we would see a slight somewhat of an increase, but it may not get up to that pro rata amount for the remaining three quarters and we think the second half would so maybe there's more than half of the revenue is in the second half of the year. Operator00:20:27Thank you. And the next question will come from RK Ramakanth from H. C. Wainwright. Please go ahead. Speaker 500:20:35Thank you. This is RK from HCW. Good afternoon, Pete. So continuing on some of the thoughts on the clinical trials, so the DFU training study that got completed and also you plan to get the validation study completed in the second half. So what 2 things. Speaker 500:21:04One is what sort of data should we expect from these 2 studies? And 2, the data that comes out of these two studies, is that enough for any filings? Or you take these data and try to plan for a pivotal studies, so that you can use that to file with the FDA? Speaker 200:21:32Okay. I appreciate the question. It's good to talk. A couple of different things here. The training study well, the work we've done to date kind of combined, the information we've done to date, we think provides us the data needed to prepare a submission for the UK. Speaker 200:21:51So we're on track for that. It's probably a couple of months, 2, 3 months away as we synthesize that data and prepare the submission. But we do have enough data in hand to begin our preparation of that submission in the UK. It is completion of the validation study that would be the information we believe we will need for a U. S. Speaker 200:22:23Submission. So again, that's something we look to complete this year and thus would be in a position to begin preparing that submission end of this year, early next year from for the diabetic foot ulcer. What I will say is, as we think about burn and diabetic foot ulcer, we very well may end up in a spot where we think burn is the better first submission to the FDA. We're going for a de novo application here and we have 10 plus years of data on burn. And so that's our strong point to leverage the 1st Triple Crown race here in the S. Speaker 200:23:14You ride your good horse in. And so I think we're considering the order, but separately, the data would be there and the information needed for also the diabetic foot ulcer submission. And we'll work with the FDA on kind of timing of all of this. Speaker 500:23:34Very good. Thanks. And then I'm assuming from what you just said, the 76 patient study that is being conducted in Ireland, That also kind of plugs into what you're just talking about, the study that's going on in the U. S. Is that how we should think about it? Speaker 500:23:59And the other question is, at a later point, once you get through the burn indication in the U. S, can you take some of this data and use it for U. S? Or do you need to kind of do separate studies? Speaker 200:24:20We can use the data from the UK for activities in the U. S. Associated with reimbursement and procurement, so with payers and with buyers. The FDA does look for us to have U. S. Speaker 200:24:37Data. And again, we think we have a robust set of the training data. We have more work to do on the validation side to meet what we think is the threshold here in the U. S. With U. Speaker 200:24:51S. Specific data. The way to think about that work in the U. K. Is it's a subset of the overall study, but it does give us a concentrated group on which to think about, assess and maybe potentially do some publications. Speaker 500:25:11Okay. Now that you have Jeremiah on board, so I'm sure he's kind of tasked with kind of watching the deployment in the U. K. And as you stated, U. K. Speaker 500:25:24Is kind of weird in terms of reimbursement because you only have one entity to work with. But what sort of learnings would Jaramillo be looking from that experience? Because once we come back on to this side of the pond, things are quite different, both in terms of commercialization and also in terms of reimbursement? Speaker 200:25:52Yes. So there's several aspects of it, a couple of which were in my prepared remarks. It's how clinicians and facilities are using the device. It's capturing the real world data. It also is a start to commercial transactions. Speaker 200:26:10And so understanding the ebb and flow or puts and takes of entering into commercial transactions with facilities and caregivers. And that certainly is a good help for us. Anytime you can begin commercial, get through terms and conditions, get financial terms in place, All of those are very helpful input into our strategy here in the U. S. And we do look to leverage the continuing real world data we receive in the UK for payers and for facilities as we have those conversations. Speaker 200:26:49We think that will be very useful, while also FDA discussions. Speaker 500:27:00Okay. One last question for me. Speaker 200:27:03BARDA is Speaker 500:27:03a huge force behind you behind the company, which is excellent. So I'm trying to understand where all BARDA can actually help you or is it part of the plan in terms of how much they can help you in terms of not only regulatory process, but also in the commercial process, certainly in the regulatory process. Are they anyway involved in trying to make sure that you run your studies in such a way that you can get the product approved? Of course, for BARDA, they don't care about the FDA approval. They can still take the product as long as they're comfortable with the data and the utility of the product. Speaker 500:27:48But I'm just trying to understand what sort of help are you getting in terms of the regulatory process in the U. S? Speaker 200:27:58Arndt is a great partner. We very much enjoy working with them. We think our interaction with them has created a good discipline inside our company for interacting with a federal agency. So we think we're well prepared for interactions with the FDA. BARDA certainly is holding us to standards that they think are appropriate for the clinical trials. Speaker 200:28:28And I do believe that's informed by their experience with other companies working with the FDA. They do have a working relationship. I think it's formalized somewhat in a document between the two groups. But so we like the advice we receive from BARDA relative to the clinical trial work. They've been informative on, for instance, wanting the specific participation of the pediatrics. Speaker 200:29:06They're focused on having the device in both the burn centers and the emergency departments. And those things, we think those are to not only support BARDA's mission, but are good for approval by the FDA. And then as far as deployment, we think of BARDA as a bit of a distribution channel, in that they are funding, but also supporting and encouraging users' facilities to take the device on. So there'll be some number of facilities covered within this next round or option of the Project BioShield contract. And then we'll work together with BARDA on further penetration across emergency departments in the U. Speaker 200:29:54S. Speaker 500:29:57Perfect. Thank you very much, Pete, for taking all my questions. I appreciate it. I'm looking forward to Speaker 200:30:04continued discussions. Thank you, RK. Operator00:30:09And the next question will be from John Vandermosten from Zacks. Please go ahead. Speaker 600:30:16Great. Thank you and hello and good afternoon Pete and Vince. I've been going down the rabbit hole of how providers are diagnosing DFU and burn and triaging and things like that. And are we aware of how the factors that the AI systems consider when making a diagnosis and how that relates to how the system and the provider would do that? Any correlation there between those 2 that you've been able to tease out? Speaker 200:30:53I don't know that I'd say there's been a correlation we've been able to tease out as we're still in our early days of working with the payers here in the U. S. Obviously, the care setting matters, just even the difference between a burn center and an emergency department is going to be important on reimbursements. Those are 2 different reimbursement schemes, if you will, or approaches. What we believe this tool device does is better informs existing, diagnoses. Speaker 200:31:32So the process is still going to be the same, I think, for once you get into the caregiving. What we're doing, what this device will do is allow practitioners to be better informed in a couple of ways, just a more consistent we think and certainly as you get away from experts into the emergency departments are better informed assessment of viability of the skin as well as some pretty specific measurements of where the viability, non viability edge is. So how much of a burn, for instance, needs to be addressed through skin grafts or something else versus doesn't. And what's important there is the more precise you can be there, the less impact you have to the patient. Generally, these skin grafts are autologous. Speaker 200:32:29So the less impact you have to the patient somewhere else in their body at what is already a traumatic time. Speaker 600:32:37Okay. And it's been my sense, AI, we're still kind of the early days of approval for AI ML type products. And my sense has been that regulatory authorities and payers, they kind of want to know how it works and what it's looking at. I mean, do you have that same sense as well? Or are they just looking for kind of the end result, looking at those high percentage of accurate assessment? Speaker 200:33:03I think they very much want to understand what is going on. And the thing that's important for people to understand about our devices, This is a closed loop AI. It is not an iterative AI. So it does not have some of the risks and concerns you have with different approach to AI such as some of these chat bots or things like that. Said a different way, our artificial intelligence tool is running an algorithm against a closed database and it is making a instantaneous assessment considering millions and millions of data points within that database. Speaker 200:33:53And that's what the power of the algorithm is. So this is helping practitioners see what the human eye cannot see. But again, it's within a closed, I'll call it closed loop. I don't think that's the most technical term. But within a finite amount of data and there is not iterative learning where the device starts going different ways. Speaker 200:34:20There is iterative learning from adding additional data into the database, but it is still a closed environment. Okay. Speaker 600:34:29Yes. Speaker 200:34:29That being said, I do think to your point, the regulators very much want to understand what is going on. And it's even where there's really an approval process needed per indication because they want to understand as we understand it now, they want to know what's going on with each data set and each indication. Okay. Speaker 600:34:57And I wanted to also ask about the how sales will go forward. As I understand it, there are BARDA sales and then there are non BARDA sales in the U. S. Related to burn. Maybe you can explain that just so I understand a little bit better. Speaker 600:35:14I assume that there's probably certain hospitals that they would target first and then you could expand out from there to other locations that might also be appropriate candidates for buying. Is that how it works Or is there another methodology that you expect to apply when it's approved and ready to be deployed and sold? Speaker 200:35:36You are generally on point, John. What I would say is it's a partnership working together with them. Yes, this next phase, next option of the PBS contract has revenue that you would think of as a commercial sale because it would be for deployment of a device and for annual license fees. We will work together with BARDA on what centers and which emergency departments the devices would go. So they will have a significant say in where we get the 1st wave and the sites for which they're paying. Speaker 200:36:20But again, the goal is to get this have this penetrate across the 5,000 emergency departments in the U. S. In a significant way. That's what BARDA wants us to do. And we'll be working with them even if it's not through a direct funding situation. Speaker 200:36:37We will be working with them to strategize on the priority locations and to leverage their contacts in those locations. And we sort of have a warm lead across the emergency department population is the way we think about it. Speaker 600:36:55Okay. And would you sell all of the there may be some capacity constraints. Would you sell all the incremental units to the BARDA contract targets first and then go to the other ones that aren't included as part of the contract? Or would you kind of do them in parallel? I mean, there could be, I guess, capacity constraints that might limit you to do that. Speaker 600:37:19What is your sense on how that might play out? Speaker 200:37:23We don't see any capacity constraints relative to getting these devices out. We think we can work with our what we know we can work with our manufacturing partner to produce the devices needed to not only distribute to the locations anticipated within the BARDA contract, but to others. I do think it would be something somewhat relatively parallel, Whether there's a lead time where we work exclusively within the BARDA deployment for a quarter or 2. But overall, I think it would be a parallel process. Speaker 600:38:01Okay. And last one for me is on the IP subsidiary. I think you alluded a little bit to this in the call that there wouldn't be any cash, I guess, exchanging hands. So will that entity, I guess, raise cash separately after it spun off? Or will they allocate any cash to you maybe in terms of debt or something like that? Speaker 600:38:20I just was wondering how the cash flow might work between the 2 entities when it spins off? Speaker 200:38:27Yes. So we're being we don't anticipate any cash flow between the 2 entities. It is looking to be self funding. I mean, it's demonstrated that through $1,000,000 funding from an affiliate of Eric's, our large shareholder. And as part of the work he will do as CEO is he would also secure additional funding for the activities of that subsidiary. Speaker 200:38:50That would be separate and different sources than we would go to for capital for our organization. And no, we don't see that there would be cash flow going between the two entities. Speaker 600:39:01Got it. All right. Thank you, Pete. Speaker 200:39:03Thanks, John. Good to talk. Operator00:39:10The next question is from Christopher Ricoso from Partner Cap Group. Please go ahead. Speaker 700:39:18Good afternoon, Peter and Vincent. I have a couple of, I think, brief questions. The first one, apart from the efforts that you've obviously made in the United States and the UK, can you comment on any efforts in other regions of the world? I know that you've done you've spent a fair amount of time in the Middle East. If you could characterize how those efforts are going and any timing in terms of potential yields, so to speak, on those efforts? Speaker 700:39:50Also, I know that you've given guidance for full year 2024. Is it possible to look out beyond that? And if not, citing nominal numbers at least, what your aspiration is in terms of comp and annual growth rates over the next few years in terms of your revenues? Speaker 200:40:14Christopher, good to talk. Thanks for the questions. You got a couple of different ones in there. First, as far as geographies, we are focused on the U. S. Speaker 200:40:23And the U. K. Primarily here. That being said, we do have interactions going on in the Gulf Council countries. I don't know that I'd characterize it a significant amount of time, but we have interacted with parties there. Speaker 200:40:41We have attended some conferences. And we do think that's a situation where there's an opportunity to get some devices in the field and begin some testing and understand what the market opportunity might be. That environment, the Gulf Council countries generally will look to a UK approval like this CA mark that we have for the regulatory. So it sort of removes one burden. And obviously, you're dealing with a totally different regulatory environment in that and particularly say in Saudi Arabia, where it can be almost an individual decision maker that can make some things happen as far as allowing the device in the region. Speaker 200:41:25Whatever we did would be putting the toe in the water, I would say, to start testing and trials and understand the interest and things of that nature. And there are other markets that we would look at a little bit, but our primary focus is going to be here in the U. S. And the UK. Another one you would hear us talk about seeking approval would be in Mainland Europe. Speaker 200:41:51That's the CE Mark. That's a longer process than what the UK process was. And then you also have to go a little bit country by country after that. So we want to do that, but we want to really focus on meeting the timelines we've established here in the U. S. Speaker 200:42:09And the UK. Secondly, now I'm going to forget what your other part of your question, didn't write it down. The other part of the Speaker 700:42:19question was, I know that you Speaker 200:42:22go by. Growth rates. Yes, growth rates. Sorry. Speaker 500:42:24Yes. Speaker 200:42:25I would not think about it as compounded growth rates right now because the nature of our revenue is going to shift. What we've talked about is $28,000,000 for 2024 and that's our R and D revenue. I would remind you what I talked about regarding this first part of the Project BioShield contract that has a value total of $55,000,000 and runs through the first quarter of 2026. So you can probably do some math and figure out order of magnitude of 20.25 revenues from that. And then the $95,000,000 would be reflected over several years as well as we would about that would be parallel to our activity under the BARDA Project BioShield contract. Speaker 200:43:28So it's not necessarily it's such chunky and almost contract driven revenue that I wouldn't necessarily talk about growth rates, But there will be some growth in that. It's not that there's not growth, but it's just not a recurring item on which to base the number. We'll have this first phase R and D revenue for the Q1 of 2026 And then we'll have some commercial revenue beginning that will grow. And so you would see compounding there. And then we would have new commercial revenue coming in, in the U. Speaker 200:44:05S. For burn or in the U. S. For DFU, and then the UK for DFU. So multiple types of revenue coming in and it's not until we get into the commercial transactions that you really would look at something on which it would be appropriate to start building growth rates. Speaker 700:44:24I see. And one more brief question, if I may, in terms of this spin off announcement that you gentlemen made. Should I be conceptualizing this as almost like a holdcoopco structure or somewhat of a true subsidiary of if you think about it Operator00:44:45from a Speaker 700:44:46schematic perspective, is it essentially like a sidebar subsidiary where MDAI holds an either significant minority or majority stake in it? Speaker 200:45:01It would be a brother sister type arrangement within an org chart. So no, it's not a holdcoopco. Spectral AI is the holding company. SpectralMD is our U. S. Speaker 200:45:12Operating company. There's a U. K. Company in the U. S. Speaker 200:45:17And then there is a spectral IP. So, they're all that one teardown from the holding company. Speaker 700:45:25Okay. Thank you. Thank you. Operator00:45:28And ladies and gentlemen, this concludes today's question and answer session. I would like to turn the conference back over to Pete Carlson for any closing remarks. Speaker 200:45:38Thank you, Chad, and thank you, everyone, for your participation and continued interest in spectral AI. We're very pleased with the progress we continue to make and remain optimistic about our prospects for growth. We hope to speak with some of you at upcoming events, including the Sidoti MicroCap Virtual Conference on May 8th 9th later this week, at our Annual Meeting of Shareholders next week on May 14th, at the Northland Virtual Growth Conference in late June and various other investor conferences that we will announce throughout the year. Thank you and have a good evening. Operator00:46:16Thank you, sir. The conference has now concluded. Thank you for joining today's presentation. You may now disconnect.Read morePowered by