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spk06: Thank you for standing by and welcome to Hyperfine's fourth quarter 2021 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's call may be recorded. Should you require any further assistance, please press star 0. I would now like to hand the call over to Marissa Byche, Investor Relations.
spk00: Thank you and thank you all for joining today's call. Joining me are Dave Scott, President and Chief Executive Officer, and Alok Gupta, Chief Financial Officer of Hyperfine. Earlier today, Hyperfine released financial results for the three and 12 months ended December 31, 2021. A copy of the press release is available on the company's website as well as sec.gov. Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of the federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results, or performance are forward-looking statements. All forward-looking statements, including without limitation, those relating to our operating trends and future financial performance, The impact of COVID-19 or geopolitical conflict, such as the war in Ukraine, on our business and prospects for recovery, expense management, expectations for hiring, physician training and adoption, growth in our organization, market opportunity, commercial and international expansion, regulatory approvals, and product development are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the risks factors section of our S-1 filed with the Securities and Exchange Commission on January 24, 2022. This conference call contains time-sensitive information It's accurate only as of the live broadcast today, March 23, 2022. Hyperfine disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. And with that, I will turn the call over to Dave Scott, President and Chief Executive Officer.
spk02: Good afternoon and thank you all for joining us in our first earnings call as a public company. We're tremendously excited to be here and to share the vision of Hyperfine with you. On the call with me is our Chief Financial Officer, Alok Gupta. We will review our fourth quarter and full year 21 results shortly, but first I would like to introduce you to Hyperfine. Hyperfine's vision is to transform healthcare by creating access to life-saving diagnostics and actionable data at the patient bedside. Today, brain diagnostics are a single point in time and delay the time from door to discharge. Our mission is to transform that experience, first and foremost, with our portable bedside MRI system. Our initial product, our portable MRI system called SWOOP, was FDA cleared in 2020. Today, we are focused on launching that system into the hospital setting to solve significant unmet patient and provider needs. In addition, we are developing a brain sensing technology designed to use ultrasound to measure noninvasive blood pressure and flow in the brain. With these technologies, we aim to create an ecosystem of solutions over time, all based on a backbone of machine learning and artificial intelligence to drive diagnostic decision making. We have an immense market opportunity. The imaging segment alone offers a $23 billion market opportunity with potential for installations across numerous hospitals, clinics, and outpatient centers over time. The medical imaging market opportunity is our primary focus today. In addition, noninvasive brain sensing offers a $22 billion market across similar locations, including ICUs, emergency departments, ambulances, and outpatient settings. In total, we see over a $40 billion addressable market opportunity. Let me take a step back to highlight the tremendous innovation behind our swoop portable MRI system, our commercial stage technology. MRI was first developed in the 1980s, and despite progress and iterations of the technology over the 90s and through today, the issues of cost, workflow, complexity, and access remain significant challenges. Our goal is to make MRI more accessible and bring this life-saving diagnostic technology to more people worldwide. We started seven years ago with the vision to create an MRI system that was an order of magnitude lower cost, could roll on wheels, could fit through a doorway, and plug into a normal wall outlet to address the challenges of conventional MRI and reduce the barriers to access. Over the past year and a half, we have successfully brought that solution to market. One of the first challenges of conventional MRI is its cost. Upfront capital cost is typically $2 to $4 million, complemented by the cost to build specialized facilities and shielded rooms to install the system, and followed by expenses associated with site upgrades, maintenance requirements, and extensive staff training to support the system. Scheduling and workflow are another significant challenge. Patients in the ICU or emergency department often need an immediate MRI scan but it takes an extremely long time to prepare that patient for transport and to move them to an MRI suite. In addition, the transport process is complicated, consumes valuable resources, and can be unsafe for unstable patients or those on life support equipment, which is not always MRI compatible. Data shows that, unfortunately, 22% to 46% of patient transport cases to an MRI suite result in an adverse event. The time between an MRI being ordered for a patient to the time the scan is done can range up to 26 hours based on our data. Much of that time is due to the patient preparation, the intra-hospital transfer, and the transfer back to the unit. This immense amount of time is just not allowing providers to deliver on the need for immediate answers to urgent patient conditions. With our SWOOP system, similar data showed a 90-minute end-to-end process from the time the MRI is ordered to the time the scan is complete. There are many settings in which portable MRI addresses a significant unmet clinical need while significantly improving patient and provider workflow. These may be settings in which conventional MRI workflow is too lengthy or too cumbersome to support a diagnosis that's needed right away. These include acute care settings, such as ICUs and emergency departments, operating rooms, for example, to complete post-operative follow-up from a brain surgery, or in locations where the nearest MRI machine may be hundreds or even thousands of miles away, including rural America or in the context of global health. Today, just 10% of the world's population has access to MRI, and we are committed to improving that. So where have we identified an opportunity to make the greatest difference and address a tremendous need in the near term? The answer is threefold. One, in the neuro ICU. Two, in pediatric hospitals to address hydrocephalus. And three, in stroke. When patients are in the ICU for neurologic conditions, patients are typically too unstable to transport to the MRI suite for imaging. As a result, there is simply not an effective way to perform imaging in the neuro-ICU today. Most neuro-ICU patients require a brain scan once they're stable to be stepped down into a standard med-surg bed. We have seen many cases in which patients are staying in the ICU for days longer than needed, simply because the hospital can't get them to the MRI suite and ensure they're safe for a transition into a lower staff-to-patient ratio environment. We've been working with our clinical partners to build strong clinical validation to support the ICU use case. In 2021, a paper published by researchers at Yale in Nature addressed detection of brain hemorrhage in ICU patients and showed 90% accuracy in swoop imaging results compared to conventional MRI. This is great validation of our technology in exactly the market we're most focused on right now. and we continue to see a very positive response in this setting today. Secondly, hydrocephalus is an excellent use case for portable MRI. The problem of hydrocephalus is there's a buildup of fluid in the brain, in the ventricles, and this is addressed by introducing a shunt and tubing to drain that fluid from the brain to the patient's belly. Children receive this treatment for hydrocephalus and unfortunately they have to come back for scans because the tubing can become clogged. These children are receiving anywhere from 1 to 12 CT scans each year and anywhere from 20 to 50 CT scans before they turn 18. This greatly increases their chances for brain tumors and cancers due to radiation exposure. MRI is the preferred approach for imaging these children instead of CT. However, MRI is infrequently available, and as a result, the best option is to take these pediatric patients for CT scans. Our mission is to scan these children with bedside MRI as the better solution. It doesn't deliver radiation, and our technology enables a quick, simple diagnosis by showing whether these shunts have failed or are operating properly. These are just two examples of use cases where we have received overwhelming early responses to the SWOOP system. Beyond neuro ICU and pediatric hospital launch settings, we see massive potential in additional use cases and settings over the immediate and longer term. We are collecting extensive validation data on our technology and our platform in many of those additional use cases today. We currently have over 40 conference presentations and publications across stroke, hydrocephalus, MS, tumor resection, and use in ECMO, or extracorporeal membrane oxygenation. And we have systems located at leading institutions across the country with ongoing studies to add even greater validation to the utility and to the clinical efficacy of our technology. One use case in which we are intently focused on continuing to build our base of clinical data is in stroke. As many of you know, 15 million people worldwide suffer from stroke annually. It's the second leading cause of death globally. 87% of these strokes are ischemic strokes. Data demonstrates that MRI scans can better detect ischemic stroke damage compared to CTs. However, providers rely heavily on CT due to the time to transport patients from an ICU or emergency department to the MRI suite and the limited accessibility of conventional MRI more broadly. Our vision is to transform that experience by delivering bedside MRI where it is needed the most. As part of executing on that vision, we are pleased to share that we are currently in the process of engaging multiple U.S. hospitals to collect data demonstrating the clinical value of SWOOP in stroke patients. As we gather greater clinical data, we will increase our focus on driving awareness and educating the field about SWOOP utilization for the stroke use case through our direct sales team. We look forward to sharing our progress on advancing our stroke focus later this year. Now let me turn to our pipeline opportunities. We are already hard at work on our next generation SWOOP platform to expand our use cases beyond neuro ICU, hydrocephalus, and stroke into C-spine and extremities over time. We are also hard at work developing our non-invasive brain monitoring system, which uses ultrasound technology to measure intracranial pressure and blood flow in the brain. Like a vital sign monitor for the heart, such as an EKG or a pulse oximeter, This is intended to operate as a vital sign monitor for the brain. We intend to generate an ultrasound image through leads that are put on either side of the head, and from that image, extract intracranial pressure and flow noninvasively. This will be a groundbreaking technology in the measurement of vital signs for the brain. Now I've introduced our vision, our market opportunity, and the transformational potential of SWOOP. Let's talk about the progress we made in 21 and the foundation we're building into 2022. We entered into and completed our business combination with Health Corps Cattalio Acquisition Corporation, generating over 160 million in gross proceeds to our business to support our growth initiatives and leading to our listing on the NASDAQ as a publicly traded company with the ticker symbol HYPR. We brought together a management team with decades of collective leadership experience, to drive our next phase of expansion as we continue to build and develop the portable MRI market and execute strong go-forward growth. We grew our team substantially, with roughly 50 employees at the beginning of the year and nearly 200 employees of Hyperfine by the end of 2021. We are continuing to grow our sales team and broader organization in early 2022 and look forward to continuing to expand throughout the year in support of driving awareness and delivering on our commercial objectives. We laid the groundwork for commercial expansion outside of the U.S., including securing regulatory authorization to sell our swoop device in Australia, New Zealand, Canada, and Pakistan. Today, we are also in the process of seeking necessary regulatory authorizations in the U.K. and the European Union via the CE-Mark process. These are additional markets which we believe offer significant opportunity. Over the course of the year, we installed 23 commercial swoop systems, bringing our total commercial installed base to 27 units at the end of the year and our total global installed base to 70 units. We are immensely proud of our progress. and we continue to see a robust opportunity for growth and expansion into further hospitals and care settings going forward. That brings me to our 2022 expectations. Based on current trends in our business and our outlook for the remainder of the year, we are initiating revenue guidance of $10 to $12 million for fiscal year 2022. We expect to install 50 to 60 commercial units for the year roughly tripling our existing commercial installed base from 27 systems at the end of 21 to 77 to 87 systems at the end of this fiscal year. In line with our current clinical and strategic focus, we expect the majority of these systems to be placed in neuro-ICUs and pediatric hospitals in the U.S. Alloc will provide greater detail on the assumptions underpinning our outlook shortly. Before I turn the call to Alok, I would like to touch on the impact of the COVID-19 pandemic to the healthcare system and to our launch experience. First of all, the entire healthcare system, including physicians, administrators, and supporting staff, have been put under incredible pressure over the course of the past two years, and I want to recognize the resilience, hard work, and dedication of these frontline workers. I also want to recognize the commitment and persistence of our team as we initiated and expanded our commercial launch and continued to advance patient care despite meaningful time and resource constraints driven by the pandemic. These constraints, in some ways, created an imperfect launch backdrop, but they have also highlighted and, in some cases, exacerbated the challenges of conventional MRI workflows. underscoring the need for more timely and flexible solutions. For example, today, a shortage in MRI technicians, even at some large academic hospitals, has contributed to ongoing delays in MRI workflow and limited MRI availability. And over the past two years, the need for MRI scans to verify the status of patients who could be transferred from an ICU to the med-surg unit has become increasingly important as ICUs have sought to maintain and improve capacity for COVID-19 patients. These situations emphasize the need for a solution that can scan patients conveniently and deliver results quickly. Of course, our launch progress has not been without pandemic-associated challenges. One of the clearest examples has been an impact to certain hospital budgets for newer technologies due to the higher cost of care for COVID-related illness. Separately, staff shortages and remote work across nursing and hospital contracting personnel have delayed the process from initial SWOOP demo through contracting and installation. Nonetheless, our team remains very hard at work stimulating awareness of our technology and placing SWOOP systems across U.S. hospitals and at various sites around the globe in 21. And we are pleased to share that we have successfully engaged with many new hospitals year to date. In addition, we are observing that overall access to hospitals is improving as we emerge from Delta and Omicron waves with lifting limitations on visitor and industry representative attendance, for example. We are optimistic that the outlook for the healthcare industry will continue to improve gradually over the course of 2022 and that against that backdrop, we can meet our growth objectives and continue to ramp up our commercial business given our strong value propositions. I will now turn the call over to Alok Gupta, our Chief Financial Officer. Thank you, Dave.
spk05: To begin, I would like to highlight our successful, recently completed merger with HealthCorp Cotelio Acquisition Corp, which closed on December 22, 2021. In conjunction with the transaction close, our company became listed on the NASDAQ exchange under the ticker symbol HYPR. We are very pleased that we successfully closed the transaction with over $160 million in gross cash proceeds to support our growth initiatives, including commercial expansion of our soup system. Turning to our financial results for the fourth quarter and full year, beginning with the fourth quarter. Revenue for the three months ended on December 31st, 2021 was $0.4 million, compared to $0.2 million in the fourth quarter of 2020. Gross profit for the fourth quarter of 2021 was negative 0.5 million compared to negative 0.2 million in the fourth quarter of 2020. R&D expenses for the fourth quarter of 2021 were 8.9 million compared to 3.6 million in the fourth quarter of 2020. Sales, general, and administrative expenses for the fourth quarter of 2021 were 16.7 million compared to 3.1 million in the fourth quarter of 2020. Net loss for the fourth quarter was $26.1 million, equating to the loss of $2.73 per share as compared to the net loss of $6.9 million or the loss of $4.45 per share for the same period of the prior year. Cash burn rate for the fourth quarter of 2021 was $17.9 million. Now I will review full year's results. Revenue for the full year ended on December 31st, 2021 was $1.5 million compared to $0.3 million in 2020. Growth profit for the full year 2021 was negative $1.2 million compared to negative $0.5 million in 2020. R&D expense for the full year 2021 was 25.8 million compared to 14.6 million in 2020. Sales general and administrative expenses for full year 2021 were $37.9 million compared to $8.4 million in 2020. Net loss for the full year was $64.9 million, equating to a loss of $17.57 per share as compared to net loss of $23.4 million or a loss of $15.38 per share for the prior year. Cash burn rate for the full year 2021 was $47.3 million. Turning to our 2022 outlook. As Dave mentioned, based on the progress and trends in our business, we are initiating 2022 guidance of $10 to $12 million of revenue for the year. Revenue is comprised of commercial system installation and subscription revenue. We anticipate installing 50 to 60 commercial systems in 2022. This compares to four commercial systems installation in 2020 and 23 commercial system installation in 2021 and implies that at the year end 2022, we expect to have a total commercial install base of 77 to 87 sewage systems. To help you bridge our commercial system installation and revenue guidance, I would like to provide greater color on our pricing model. Over the first one and a half years of our commercial soup launch, we have worked hard to accommodate varying hospital payment preferences and budgeting capacity with many of our pre-2022 commercial contracts, including both upfront device installation and ongoing cloud and service agreement for a consistent recurring payment over three years. As we have expanded our base of hospital customers over this timeframe, We have conducted extensive ongoing market diligence around customers' expectations and experience with Soup to achieve a greater understanding of the immense value that our system delivers. As a result of these insights, we have introduced a new pricing model based on an upfront device purchase price of $250,000 per unit and an annual subscription payment inclusive of our cloud and service agreement of roughly $50,000 per year. Our contracts will continue to span three years. Importantly, our book orders and contracts in negotiation year to date are based on a mix of our legacy and new pricing models. And as we have done in the past, we will continue to offer a degree of flexibility for customers to finance a swoop installation through their capital budget or through an annual subscription plan. However, we anticipate that as the year progresses, we will fully transition our commercial installation to our new pricing model with a greater upfront payment component. As a result, we expect our average revenue per device to increase over the course of the year. Shifting to our additional expectations for the year, to complement our formal guidance and pricing detail, I would like to provide some P&L commentary to help you with your models. We anticipate revenues to increase quarterly throughout the year. with first quarter revenue of roughly $1 million. We anticipate a negative gross margin to start the year, with gross margins turning positive in the second half of the year. We anticipate spending over $80 million in total operating expenses for the year, with a slightly great focus on SG&A relative to R&D, considering our sales team, clinical success team, and broader headcount growth intentions. Our cash and cash equivalent total revenues $188.5 million at the year end 2021. And we anticipate our cash burn of approximately $80 to $90 million in 2022. At this point, I would like to turn the call back to Dave for closing comments.
spk02: Great. Thank you, Alok. I'd like to close by highlighting the great leadership team we have brought together here at Hyperfine over the last six to nine months. This is a team with decades of collective experience across critical areas of expertise. First of all, Alok, on the call with me today, joined us as Chief Financial Officer with over 20 years of experience in the financial and banking industries. Dr. Khan Siddiqui, our Chief Strategy and Medical Officer, brings a very impressive background in entrepreneurship alongside his experience as a board-certified radiologist with leadership positions at Johns Hopkins University and the University of Maryland. Tom Tessier, our Chief Product Officer, brings an extensive background in medical technology and imaging and was the head of Surgical and Implantable Devices and a founding member of Verily Life Sciences, formerly known as Google Life Sciences. Scott White, our Chief Commercial Officer, has 20 years of experience in the healthcare industry and specific experience in building and developing new markets through years at Intuitive Surgical. Kyla Pavlina, our Chief People Officer, brings extensive med tech and healthcare human resources leadership experience to the company. Anila Paykel is our General Counsel and Chief Compliance Officer, who brings 25 years of legal experience across technology, healthcare, and life sciences law, having held leadership roles at Waymo within Alphabet, Genentech, CVS Caremark, and Blue Shield of California. With an incredible opportunity in front of us and this experienced leadership team, we are confident in driving significant growth in the business and ultimately democratizing access to imaging and sensing around the globe. With that, I want to thank you for your time and open it up to any questions.
spk06: As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Again, that's star one on your touchtone telephone to ask a question. Please stand by while we compile the Q&A roster. Our first question comes from the line of Vijay Kumar of Evercore ISI. Your question, please.
spk04: Hey, guys. Thanks for taking my question. Maybe, Scott, the first one on system placement assumptions here, 50 to 60 systems for fiscal year 2022, If I go back six, nine months, and I recognize the world has changed, but nine months ago, I think the expectation was 200-plus systems installed-based exiting fiscal 22. The guide implies, I think, around 80 systems installed-based exiting fiscal 22. Maybe just walk us through on what the impact from – Omicron has been in your ability to hire sales teams, accessibility to hospitals. How big of a deal has that been for the company? And help us understand the visibility you have and those placement numbers, 50 to 60.
spk02: Absolutely, Vijay. Thanks for the question. Yes, we're really excited about our outlook for 2022. This represents a 7x year-over-year growth in our revenues compared to last year. As you point out, COVID was impacting our ability to run demos and execute demos in hospitals. We found that many hospital centers were simply not able to give their attention to the contracting process for purchasing new equipment because they were really just swamped with with dealing with COVID. And then accessing physicians was also limited. We're seeing that starting to open up now as the Omicron wave is transitioning off, and we're really excited about our growth this year. The other thing that we focused on last year and the first quarter of this year was really sharpening the pencil on our value propositions. And while we have this immense market opportunity, portable MRI, bedside MRI is inevitable, as we've discussed. And it is going to transform MRI imaging. But we need to also focus, especially this initial year of our commercialization. And so over the last nine months, we've been really digging deep to understand our value proposition and focusing on neuro-ICU, hydrocephalus, and then as we build the clinical validation data in stroke. And that's allowing us to focus our sales team in these beachhead areas where it gives us a set of physicians and hospital centers call points to focus on. This community, especially the pediatric community, is a very tight-knit community. And so the word of mouth there is very important. And so we see that as our beachhead entry point to build a foundation and a foothold in these neuroICUs and pediatric centers, and then as we continue to build our clinical validation data in stroke. And so, you know, with that, I'm super excited about our growth plans in 2022 and beyond and to tackle this giant market in front of us and looking forward to adoption of the technology
spk04: this year understood and maybe one on a couple on the cash flows and revenue guidance I think Q1 revenue outlook of a million dollars I think the annual is in the low double digit range almost implies a sequential step up by a million for every subsequent quarters the phasing seems to be one stepping up to two, three, and four. So there is an implied, you know, the guide is implying a sequential step up here on systems. Just walk us through on, you know, if we're starting Q1 systems maybe in the single data trench, how, you know, what is the path to any, you know, exiting Q4 north of 20 systems? What visibility do we have? Is that predicated on this word of mouth ability for HyperFind to demo the system or what needs to happen in allowing the company to hit that 50 to 60 number?
spk02: Yeah, great question. So it's a combination of a couple of things. One is building the market awareness of the technology, building the market validation through clinical data that supports the the value proposition, and also our sales force building their experience, knowledge, the tools, and the pipeline that that team has been building out. So our sales force is relatively new. I'd say a year ago, the sales force was just a handful of people, and so we now have a significant sales team that's going after this opportunity, but you know, it's their productivity that we're working on growing and increasing as they gain their knowledge, build their connections, and build their pipeline, as well as on the market side, you know, this is a brand new market, right? So we're creating a market that doesn't exist today. And part of that market creation, there's building the awareness, building the clinical validation, combined with, you know, COVID and Omicron, phasing out so that hospitals can turn their attention back to adopting new technology. And so it's the combination of all those factors and, you know, driving that adoption curve, that S-curve that everyone understands well in new markets is we're really at the early stages of that S-curve. And so driving the shape of that S-curve is our goal is to drive that through the increased productivity of our sales force, increased market awareness and market understanding of the clinical value proposition that we provide.
spk04: That's helpful, Scott. And that segues me, segues nicely into my last question here. Maybe this is one for Alok. I think you mentioned cash burn of $17 million in Q4 2020. The cash balance ending December 31st was north of $180. Maybe talk to us about the cash position right now, Alok. And as Scott laid out, there's the billing awareness, right? How should we think about OPEC spend ramp? And do you feel like you have enough cash on the balance sheet to support those initiatives? Yes.
spk05: Yeah, so Vijay, thanks for that question. As I mentioned, we're thinking about OPEC spend to be $80 million in that ballpark for the year. And obviously there's more focus on the SCNA part of it, primarily driven by the sales and the customer support team. So you rightly pointed out, we started the year at $188.5 million of cash and cash equivalent. I'm excluding the restricted cash in there. But then if we were to burn $80 to $90 million, we'll be in a very strong position entering 2023.
spk06: Thank you. Our next question comes from Lawrence Bigelson of Wells Fargo. Your question, please.
spk03: Hi, this is Charles. I'm for Larry. First question, just maybe digging a bit more into the revenue guidance here. I wonder if you might be able to give a little bit more color on the You can talk about maybe the split between services and devices. It's a little heavier on the service side in 2021, if you expect that to continue or how that mix might shift, as well as wondered if you might give any color on U.S.-O.U.S. split, as well as, lastly, if you have any thoughts to share on contrast revenue per scan there, if there's anything that's a meaningful amount there. And then I have a follow-up.
spk02: Thanks. Great. Thanks, Charles. Thanks for the question. As Alok mentioned earlier, we gained extensive experience last year on the pricing of our system and the value proposition of our system. We found that a number of customers, there were some customers that wanted to put the cost in their operating budget. Some customers wanted to put their cost in capital budget. We found that there was a lot of opportunity to increase our pricing. So we increased pricing on the capital side, and that's where you see the shift in the pricing model. We have many deals that were still in the pipeline from last year that were using the old pricing model. So we really just rolled out the new pricing at the beginning of this year. So we won't see too many deals that close in Q1 with new pricing. So there will be a mixture this year. of pricing models more heavily skewed to the old pricing model in Q1. Um, and so I hope that, I hope that answers that, that question. Um, and what, what was the second part of your question, Charles?
spk05: He was asking.
spk03: Yeah. Yeah. First, just if you can share anything about, um, I think you gave total worldwide numbers. If there's any thoughts on a U S O U S split of what's happened or how you see that, uh, going in 2022, as well as, uh, maybe contrast revenue and just how many scans you're using contrast?
spk02: Yeah, great question. So our focus is in the U.S. primarily. Now, we do have clearances in Australia, Pakistan, Canada, and New Zealand as well, and so we are exploring those markets outside the U.S., but our primary focus and where we're building our sales force and direct selling is in the U.S., and we see a a predominance of sales happening in the U.S. with some system sales OUS in those countries throughout this year, but that'll be a smaller number. And we are working on contrast agent clearances, but we currently do not have a clearance in using contrast agents, so we don't have any revenue. There's no revenue contribution from contrast agents today.
spk03: Okay, thank you. And then then a quick follow up here. I mean, more forward looking, but so you talked about a lot of the pipeline opportunities, their brain sensing and the additional use cases. I didn't hear any timelines. But is there anything we should expect to hear or updates or data or anything in 2022? We might see or a little bit beyond that you might be able to share?
spk02: We expect to do submissions for our V2 platform in 23, as well as in our brain sensing as well. So we would have updates at that time when we do FDA submissions.
spk06: Okay, thank you. Thank you. Our next question comes from Anthony Patron of Mizuho Group. Your line is open.
spk01: Thanks and congratulations on a strong 2021. I'll start off with a couple on guidance and then a couple of workflow questions at active commercial sites. And so on guidance, the 50 to 60 commercial installs for 2022, I'm just wondering when you look at the install base, there's 50 noncommercial units, either grant fulfillment or research. Does the guidance contemplate any transition of those systems to commercial units? And if so, what is the revenue event on a transition? And then I'll have a few follow-ups.
spk02: Hi, Anthony. Yeah, thanks for the question. So, no, I mean, our guidance this year does not include any revenue that would come from converting existing research sites into commercial systems. That would be upside to the guidance. And we are working on that with various research sites. There are research sites that are kind of in various phases of that. But the current guidance does not assume that.
spk05: And if I may add, the grant is not an upside. It's for the Bill and Melinda Gates.
spk01: Those units are one-time grants. I see. And I guess of the 50, how many of, how does the 50 split out between grant and research?
spk05: No, 50 to 60 is all commercial installation. So if you were to do apples to apples comparison, Anthony, last year we have put out all these numbers by quarter. 23 were the commercial installation last year of the total install base of 41. So 23 came from a commercial installation and the rest of them were primarily Bill and Melinda Gates. So year-over-year, 23 will become 50 to 60 units, if that helps.
spk01: Okay. No, that's helpful. And then on the 50 to 60 commercial, are those more considered really backlog or funnel? In other words, have a portion of those already begun the contract to bring in a swoop system, or are they more just kind of earmarked as funnel opportunities? Yes.
spk02: Yeah, so it's both. So especially in Q1, these are deals that we're closing that were started back in 2021 as part of the pipeline, as part of the funnel. And then throughout the year, we'll see those eventually closed out. And then the latter part of the year will be dominated by new deals that are started this year.
spk01: That's helpful. And maybe a couple on... On workflow, so one of the benefits for SWOOP, of course, is the dramatically reduced time for MRIs. So the delta between the MRI order and the post-MRI exam. I'm just wondering, I think in the due diligence phase, that was reduced by almost half in certain cases. And so in the real world, are you seeing that reduction in time flow between ordering the MRI and a post-MRI exam? So maybe just a little bit on the workflow experience for the 23 active commercial sites.
spk02: Yeah, great question. You know, the data that we collected was in a real scenario, in a real hospital, real-life data for that particular hospital center. It was 26 hours versus 90 minutes, so dramatic improvement in their workflow. And it's not just the time benefit, but it's also, in many cases, these patients can't be sent to imaging at all. So by imaging them at the bedside, they're able to identify pathologies that would have been missed entirely. So we're seeing examples of cases where patients are getting imaged and diagnosed, and that diagnosis wouldn't have occurred at all. And also specifically in some stroke cases, It's saving lives or saving life function because they're catching the stroke situation sooner and able to make treatments that they wouldn't have otherwise been able to treat. So we are seeing this value proposition playing out across all of our centers. It's both in workflow and it's enabling diagnosis and treatment that would have otherwise not happened at all. Some other exciting work that is coming out of our research area is, and I alluded to earlier, is in MS. So the NIH has been doing some studies with using our system to image MS patients. And so we're getting exciting results there, as well as, as I mentioned, ECMO patients. So ECMO is effectively a cardiac bypass. And these patients sometimes are on these systems for up to two weeks at a time. And it's simply impossible to image those patients with traditional MRI. The equipment is metallic. There's no way to transport these patients to an MRI suite. And so they're able to get the images and the diagnosis they need at the bedside of these patients, which would simply be not possible with traditional MRI. So it's really an enabling technology for them. And so we're really excited about these applications where it's allowing physicians to do something that not only save time, but do something that they simply could not do otherwise.
spk01: That's helpful background. Last one for me, I'll hop back in. Just on the additional use case, there was an economic benefit, certainly the hospitals, and there's already a billable code in place with contrast. And so maybe just again on those 23 active sites, how seamless has reimbursement been for those sites and You know, is there any kind of numbers you can put around in terms of quantifying, you know, how substantial the uplift has been on imaging cases as well as reimbursement dollars when using SWOOP? Thanks.
spk02: Great question. Yeah. So as you point out, our platform is qualified to be billed using the same MRI imaging codes as traditional MRI for non-contrast, 70551. And so hospitals and imaging centers are able to use this code when they use our platform for imaging. We have not heard of any problems with that. And so hospitals are successfully using that billing to bill for the imaging and the treatment of their patients. And so we expect that to continue, the benefit of that to continue over time. as well as the expanded use of our platform across these use cases of neuro-ICU pediatrics and for hydrocephalus kids. And so we're excited about the opportunity there.
spk01: Thanks again.
spk06: Thank you. At this time, I'd like to turn the call back over to Dave Scott for closing remarks. Sir?
spk02: Thank you very much and appreciate all of the questions and appreciate everyone joining the call today. Just wanted to do a few kind of final statements. We're just super excited by the opportunity that bedside MRI presents. We believe this is an inevitable technology. We believe in the inevitability of moving MRI from the fixed room that it's in, the high cost and the lack of access. to a world where we bring MRI to the patient bedside and ultimately to develop our next generation platform as well as our brain sensing technology for measuring intracranial pressure and flow in the brain. So we're building out this platform and this ecosystem of technologies built on a machine learning platform and artificial intelligence that will elevate our ability to bring lifesaving diagnostics to the patient bedside. And with that, I just want to thank everyone for their time and thank you to the folks on the call with the questions. Really appreciate it and look forward to speaking with you at our next call.
spk06: And this concludes today's conference call. Thank you for participating. You may now disconnect.
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