Welcome to the IRRAS Audiocast with Teleconference Q4 2021. For the first part of this call, all participants will be in listen-only mode, and afterwards there'll be a question and answer session. Today, I am pleased to present Will Martin, CEO. Please begin your meeting. Thank you very much, Operator. Good morning, everyone. Welcome to the IRRAS Q4 2021 report. My name is Will Martin, President and Chief Executive Officer of IRRAS, and I'm pleased to be able to present to you our company's performance for the fourth quarter of this past year. Moving forward onto the second slide, I will be making potentially throughout the course of the presentation forward-looking statements that I want to provide the appropriate disclaimer for. Moving forward to Slide 3. It's important to note, and we're excited to report that the fourth quarter of 2021 was our sixth consecutive quarter of revenue growth as a company. For the quarter, we posted SEK 7.2 million of revenue, up almost 20% quarter-over-quarter and up almost 200% from the fourth quarter of 2020. Finished the year of 2021 at SEK 22.4 million, which is essentially 3x the revenue, 200% plus growth from the annual revenue in 2020. Associated underlying metrics that we'll talk more about later continue to move in the right direction, both in terms of annual growth and quarter-over-quarter growth in terms of commercial systems in the United States, as well as the number of IRRAflow systems placed with customers or shipped to customers globally. For the fourth quarter, both our earnings per share and/or earnings before income and taxes both were artificially depressed both by rising supply chain costs, the added cost of ramping up inventory for our pending next-generation IRRAflow launch in the United States, as well as a decision to go ahead and write down existing inventory of the previous-generation IRRAflow. That created a depressed earnings and margin for the fourth quarter. We also feel that that provides us the opportunity to turn the page and set ourselves up both in terms of top and bottom line improvements as we move into 2022. Moving forward to Slide 4. During the fourth quarter, several significant events that we previously announced that I wanted to highlight. We received the CE mark for the next generation enhanced IRRAflow catheter. It's an enhanced catheter with both improved kink resistance and superior drainage capabilities, now approved for use and being used to treat patients within the European Union. Our efforts to expand the available clinical evidence to support the IRRAflow system continued to gain acceleration. The first patients were enrolled in the ARCH clinical study looking at IRRAflow plus the use of clot-busting medication led by the team in Helsinki. Also the team at Aarhus University in Denmark initiated their commercial patient treatments with IRRAflow and are capturing those outcomes as part of the ACTIVE clinical trial. Furthermore, during the fourth quarter, we established a commercial partnership with Lovell Government Services to accelerate our ability to penetrate the U.S. government and Veterans Affairs hospital systems. Lovell is a service-connected, disabled veteran-owned enterprise, has established contracts with these government agencies and will allow us to accelerate product approval within these facilities. Since the end of the fourth quarter on Slide 5, we've continued to advance the collection and presentation of clinical data with the IRRAflow system. After initiating the active clinical study, Aarhus University has begun to actively enroll patients there in Denmark. West Virginia University just a couple of weeks ago, as we announced, presented the largest IRRAflow data set to date, confirming that the system's mechanism of action resulted in a 0% rate of catheter blockages and also improved outcomes for patients with reduced incidents of infection, clinically significant vasospasm, which is vessel constriction, if you will, as well as long-term dependence on implantable shunts compared to traditional drainage. All of these results very much in favor of IRRAflow and will continue to build upon this patient experience in West Virginia. We also have announced that another patent was issued for the IRRAflow system that further protects our ability to cover ourselves and cover our intellectual property for the administration of therapeutic drugs using the system. Looking at those high-level results and significant events, moving forward to Slide 6, we have the key financial data. As previously discussed, revenue for the quarter, SEK 7.2 million. Revenue for the year, SEK 22.4 million, up significantly from previous year, as previously discussed. Earnings, both overall as well as earnings per share, were suppressed by the write-down primarily of existing inventory in the United States. Our cash flow has continued to be relatively steady from 2020 to 2021. We have SEK 55.9 million of liquid funds at the end of the period. Based on these available funds, we have initiated steps to secure the needed financing to extend the cash runway for the organization, and we'll provide more details on that process in coming weeks and months, as that process continues. Moving forward to Slide 7. From a high level, those of you who have followed IRRAS for some time now know that we are a Swedish-American company focused on delivering innovative products for neurocritical care. We are headquartered in Stockholm, with facilities both in the United States, San Diego, California, as well as our global logistics provider being based in the Netherlands. On Slide 8, you can see that we are targeting a sizable market opportunity. Our total addressable market estimates have increased from our last report as we've continued to get updated analyst and research reports. We now estimate that the intracranial bleeding market opportunity in the EU and U.S. alone now is more than $1.8 billion, as you can see on Slide 8. The total market opportunity for traumatic brain injury now is estimated at approximately $600 million. When you combine that with what we see overall from the drug delivery market opportunity, you're looking at a sizable market opportunity of north of SEK 7 billion, all in. We're now targeting and trying to identify exactly how much of that drug delivery opportunity is applicable for IRRAS in the short term. All in all, we are able to target and go after a meaningful market opportunity in neurocritical care. Moving forward to Slide 9, please. As you're aware, our two lead products are two products in our portfolio. IRRAflow is our lead product, the world's first irrigating intracranial drainage system. And Hummingbird, the complementary product, to assess a patient's intracranial pressure. We now have both diagnosis and treatment capabilities within the broad spectrum of neurocritical care. On Slide 10, the elements of the IRRAflow system, it really is a razor blade model. A small piece of capital equipment that is connected to two single-use disposables, both the IRRAflow dual lumen catheter that's placed inside the patient's intracranial space, as well as the IRRAflow tube set and digital cassette, which connects the catheter to the control unit. This digital cassette really is the brains behind the entire patient treatment, with the digital pump that regulates both continuous irrigation and controlled drainage. On Slide 11, the mechanism of action is shown for the IRRAflow system. While you have a static image here, you can see very easily that the orange catheter quickly has solid particulates that has collected at the drainage holes. IRRAflow on the right, with the automated irrigation of the system, those drainage holes are free from occlusion formation. Now, in more than 300 patient treatments, when the system's irrigation is actively employed, and confirmed by the evidence presented at West Virginia University, a 0% catheter occlusion rate has been observed. That is compared to occlusion rates up to 47% that have been published in peer-reviewed literature for traditional passive EVDs. That mechanism of action for IRRAflow that's shown on Slides 10 and 11 now is being translated into our next-generation system that's highlighted on Slide 12. The system with its automated irrigation, continuous drainage, and patient monitoring of their intracranial pressure is now being combined with a next-generation software that has additional training capabilities, additional support for nursing staff, so our team to be able to support patient treatments remotely. Earlier today, we finished our internal processes to be able to ship the first next-generation commercial systems here in the U.S. this week. We've begun training at the first wave of accounts that'll be part of the limited market release, and we expect first patients to be treated with this next-generation system within the next couple of weeks here in the United States. This will be the platform technology upon which our next wave of growth with the IRRAflow system will be built. The initial feedback from our customers here in the U.S. is a high level of excitement and optimism about their upcoming experience with the next generation system. We look forward to providing additional updates on experience with this system and customer adoption as we move forward and continue to update the market. On Slide 13, again, we'd like to stress that IRRAflow and our commercial clinical experience to date has confirmed that the system is extremely versatile across a broad range of intracranial pathologies, from collection of blood between the brain and the skull, so-called subdural hematomas, to blood deeper within the brain, whether bleeding within the brain tissue, intraparenchymal hemorrhage, or blood that has collected within the reservoirs of cerebrospinal fluid in the brain, so-called intraventricular hemorrhage. The system has been shown, with its irrigation fluid exchange capabilities, to be a very capable tool for combating aggressive infections that may spread into the brain. Across these multiple disease states, IRRAflow continues to deliver superior clinical outcomes for patients. Another one of those is shown on Slide 14. This is a case that was treated actually since the beginning of 2022 at one of our new hospitals here in California, a comprehensive stroke center, Santa Barbara Cottage Hospital just north of Los Angeles. This was a hospital that during the fourth quarter of 2021 placed its disposable order to evaluate the IRRAflow system, and one of their initial patient treatments is shown here on Slide 14. The patient who entered into the hospital had an intraventricular hemorrhage, and the IRRAflow catheter was inserted within the ventricle. Four milligrams of thrombolytic medication was utilized within the irrigation solution. Within only 36 hours of treatment time, you can see the drastic difference between the pre-IRRAflow image and the post-IRRAflow image. This patient had catheter removed on day three. In traditional therapy, this is a case where surgeons would have predicted anywhere from 10 to 14 days of treatment time with traditional passive drainage. A very encouraging start to our evaluation at Cottage Health. In an extremely short period of treatment time, you can see the drastic difference between the pre and the post image. Those types of clinical outcomes continue to be built upon, and you can see that in more detail on Slide 15. Several weeks ago, we announced that the team from West Virginia University presented their experience to date at the Neurosurgical Society of the Virginias annual meeting. This is the first 45 patients that they had treated with IRRAflow at the Rockefeller Neuroscience Institute in West Virginia. This is during the early learning curve with the system. Of these 45 patients, 24.4% had some type of medication delivered through the IRRAflow system. During entire course of treatment, there was a 0% catheter occlusion rate observed with IRRAflow. That is compared to significantly higher rates, 19% permanent occlusions that would require replacement, 40%+ temporary occlusions with traditional drainage. In addition, shunt dependency rates were lower with IRRAflow, meaning that more blood was removed and less residual blood impacted fluid movement through the brain. A long-term shunt, an additional surgery was able to be eliminated through the use of IRRAflow. Vasospasm, deadly constriction of vessels within the brain due to the inflammatory response caused by blood byproducts, was also shown to be significantly lower with IRRAflow, meaning that the IRRAflow cases resulted in more thorough blood removal. 17%-25% vasospasm with IRRAflow compared to 40%-70% rates documented in published literature. It's a very encouraging data set for us here at IRRAS. This is something that we're now going to build upon, not only with more data from West Virginia, but we're also working with other facilities to expand this data set with their early treatment experience as well. Throughout the year, the course of 2022, additional data points will be presented at upcoming scientific conferences to share even broader experience with IRRAflow. On Slide 16, you can actually see one of the cases that was presented by West Virginia, and this is one that truly documents in vivo the performance of the IRRAflow system. This is a case where on day 4, after the IRRAflow catheter was placed directly into organized clot, the surgeon had to go in and do a follow-up surgery. When a camera on the end of an endoscope was placed into the ventricles, they were able to see patent drainage holes in vivo within an active patient treatment with IRRAflow, drainage holes free from occlusion and drainage holes actually still drawing in strands of fibrin and continuing to remove these toxic collected blood byproducts. This was very exciting for us as well to be able to see within an active patient treatment the system doing exactly what it was designed to do. These types of results on Slide 16 are what led to the encouraging clinical data that the hospital also presented. As we shift over from the clinical side and how the system works over to customer reaction and increased metrics documenting customer adoption. On Slide 17, you can see the sixth consecutive quarter of growth during the fourth quarter of 2021. Growth from SEK 7.4 million to more than SEK 22 million in 2021. 3x totals, 200%+ growth being driven not only by continued strong usage and adoption and reorders in the United States, but also continued expansion and growth as our distribution partners globally continue to ramp up their activity. You can see on S lide 18, confirmation of the continued expansion of our razor blade model. Another quarter of growth in the number of IRRAflow systems that have been shipped globally. We're now up to 131 systems that have been deployed to either customer sites and our direct accounts or to our distribution partners. The number of commercial systems in the U.S. continues to increase. The number of evaluation systems in the U.S. actually went down slightly during the fourth quarter. That was because of the conversion over to commercial systems, which is exactly the conversion that we hope to see. We want more hospitals deciding to use IRRAflow long term as opposed to just continuing to evaluate it. The number of systems with our European direct customers as well as our distribution partners continues to grow as commercial activity increases. On Slide 19, now we can start to see how that razor blade model, having the capital equipment in place on the left over the last several years, significant increase in the number of systems since the beginning of our commercial launch in the U.S. is now driving the associated total revenue growth. Now up north of SEK 22 million. On Slide 20, this is in my mind the most important slide in the entire deck because we're seeing more and more of our U.S. revenue being driven by continued usage and continued adoption at key hospitals in the United States. Over the last four quarters, we've gone from 17% of our U.S. revenue driven by disposable reorders from existing customers to almost 80% of our U.S. revenue during the fourth quarter was driven by existing commercial customers. Reorders from our key accounts are continuing. This is a testament to the deep not wide strategy that we've talked about of growing usage, increasing revenue from the key accounts, building support from key opinion leaders, and now working to replicate that success at our next wave of evaluations that are being completed and our next wave of new accounts that are coming on board, not only in the United States, but also in other parts of the world. As you look from a broader perspective during the fourth quarter, plenty of commercial highlights to discuss. In addition to that continued adoption being shown in the United States, we received a IRRAflow commercial stocking order as Vidant, a comprehensive stroke center in North Carolina, converted from an evaluation over to a commercial account, started the evaluation at Cottage Health, where we looked at one of their initial cases several slides ago. Our global distribution network continues to grow as we added partners in the Baltic countries, the Czech Republic, and Bulgaria. Another new IRRAflow evaluation was initiated in Germany. West Virginia University, in order to support their increased IRRAflow usage, not only ordered more disposables, but expanded the contract that we have in place, the capital placement agreement, to add three additional IRRAflow control units at the hospital. They now have gone from two IRRAflow systems to five at West Virginia to support driving growth. All of this was able to be accomplished in spite of the challenges that were faced during Q4 as COVID-19 restrictions returned due to the Omicron variant. Our distribution partners continue to increase their activity, and first patient treatments were successfully completed in Croatia, Mexico, and Lithuania during the quarter. Across all elements of our business, forward progress continues to be seen, whether it's direct accounts, adoption, and a record number of patient treatments, or commercial activity from our distribution partners. All occurred again during the fourth quarter of 2021. On Slide 22, you can see that we're doing all of this and have done and have shown this type of progress over the last six plus quarters without additional very small increases in the amount of what is being spent on marketing and sales. In coming quarters, we'll start to break out the admin costs in more details. We're spending more on clinical trials and other things, and we want to provide additional clarity to investors on that front. The total spend since the beginning of the pandemic on sales and marketing has been almost flat for us as an organization. Even with a similar size team, we're producing 3x the revenue and a record number of patient treatments quarter-over-quarter. As we clarify our financing plans moving forward, our goal now is to begin to accelerate the size of that team and be able to further accelerate the revenue growth that we're seeing. The overall ratio of operating expenses to sales continues to move in the right direction, showing that we're driving more revenue with an increased focus on cost consciousness. We're going to be able to do that even more, as you can see on the next couple of slides. During the fourth quarter on S lide 23, meaningful data continues to be presented. In addition to the West Virginia data that was presented earlier, the team from Helsinki presented their roll-in cases. These are the cases that are setting the stage for the ARCH study. This was presented at the Congress of Neurological Surgeons annual meeting back in October, the beginning of Q4. 5 cases that show the effectiveness of IRRAflow when infusing thrombolytic medication. All of the five cases demonstrated 90% blood removal in 72 hours. All cases were completed in an average of 5 days. That compares favorably to the comparative trial of TPA in traditional EVDs, which required an average of 14 days in the ICU. As we kind of build upon this data set on Slide 24 with the enrollment of the actual ARCH and ACTIVE clinical studies, we are encouraged that the data that will be presented, particularly as we get into the interim analysis, will further confirm the mechanism of action of IRRAflow. We now have five patients enrolled in Helsinki with the ARCH study, and we're working to bring on additional sites, both in Europe as well as the United States for this trial. The ACTIVE study now has enrolled three patients at Aarhus University in Denmark, and we're now engaging other sites throughout Denmark about potentially participating in the ACTIVE trial as well. These are both comparative studies that will document the IRRAflow mechanism of action compared to traditional treatment. These have the potential to be transformational for us and our business in documenting the superiority of our products. We will continue over the next handful of quarters to invest in support of these clinical activities. As you can see on Slide 25, they drive the key corporate milestones moving forward, continuing to enroll in these clinical trials, documenting that IRRAflow superiority, and helping to support continued revenue growth as a result. Beyond that, we're continuing to work with DEKRA, our notified body, to put the needed paperwork in place to support the CE mark for the Hummingbird system, which will then generate European revenue. Now that we have the next generation system commercially available in the U.S., we're now working with our notified body DEKRA as well to upgrade IRRAflow to MDR and be able to launch this enhanced system in Europe at some point later this year as well. Those are our key areas of focus for the remainder of this year, and we're excited about our ability to execute upon those. On Slide 26, to summarize, IRRAS is as well positioned for growth as we've ever been. We're increasing the level of physician thought leader support. That's helping to drive the pool of available clinical evidence. Leading institutions around the world are growing the pool of early adopters with positive feedback and encouraging clinical data. Our commercial launch continues to move forward, not only growing the business in our direct markets with new evaluations, but now seeing increased activity with our distribution partners and reorders starting to come in from our distribution partners all around the world. Feeding the attractive business model, whereas we continue to work, we can scale the business with our in-house capital equipment manufacturing, continue to move further in the direction of documenting and showing the attractive medical device margins that are capable with this product line as we continue to grow. As we discussed earlier, aside from the inventory write-offs and the challenges with supply chain right now, we have a significant focus in the organization on controlling costs across the board. That leads on Slide 27 to what we feel is the fact that even though we continue to be challenged in the overall marketplace, with our share price and our continued need to fundraise, the IRRAS investment thesis is stronger than ever. Despite these challenges, we've removed the barriers to growth. We are primed for continued revenue growth moving forward, as we've done for the previous six quarters. Our products on a daily basis are confirming their ability to address significant market needs, significant patient needs, in sizable markets, with significant opportunity for innovative solutions. We have a team now of just under 50 employees that allow us to control our own destiny in key markets. Now that we've removed product developments and regulatory risk, all the pieces are in place. As we continue to accelerate through 2022, we're excited for this story to become even more dynamic and compelling to investors. So in summary, the fourth quarter of 2021 continued to show the needed forward momentum in terms of commercial adoption, and we're excited to continue that for our patients, for our customers, and for our shareholders throughout 2022. On Slide 28, we encourage you to follow along closely through all of our available channels, whether it's social media, the IRRAS Academy app, or our IRRAS Radio podcast collection. All of the various updates are uploaded across all of our channels to make sure that our shareholders every step of the way can stay up to date on our exciting progress. With that, I thank you for your time. I'll hand it back over to you, operator, to open it up for any questions that may be out there. Thank you very much. Thank you. Ladies and gentlemen, if you have a question for the speakers, please press zero, one on your telephone keypad. Our first question is from Oskar Bergman of Redeye. Please go ahead. Hi, Oskar. Good evening. Yeah, hi. Good evening, Will. I was wondering about the cost of goods sold line item. Yes. When we can begin to see this stabilize. Are you going to write down more of the 3.0 version also in this quarter? Yeah, that was a lot of what drove the increase in cost of goods sold during the fourth quarter. Within the fourth quarter, we went ahead and wrote down the existing what we call the 3.0 control units in anticipation of the 4.0 launch. Obviously the supply chain constraints in the global marketplace now are challenging for us like many other companies. We're navigating our way through those. During the quarter, we also had to build up some of our components to build the new control units. You know, a majority of the increase in COGS during the quarter was due to the write-down of the legacy systems. Our expectations are in the first quarter of 2022 and beyond, that will significantly stabilize and show just what is capable of this company from a margin standpoint, since we'll be relying upon the 4.0 control unit for the foreseeable future, Oskar. Are you planning on transferring some of the R&D costs from the admin line item already also in this quarter? One of the things that we're committed to, we've been working with our auditors on, is breaking out all of the various pieces in more detail. One of the things that has historically been done is some things such as clinical trial costs are currently within our balance sheets, captured within admin, but not broken out in specifics. In coming quarters, we've been working with the auditors to break out both R&D and admin costs into much more detailed subgroups, so you can see exactly where the money is going. Now, instead of including clinical trial costs under the admin line, that'll be shifting over to the R&D line and will be broken out in much more granular detail and clarity for both those such as yourself who follow the company and our shareholders in future quarters. Another question that I've asked more or less every conference call now is when you're going to accelerate the hiring of the sales team. Is this something that you expect to do now as restrictions are lifted, or will you have to await a strengthened financial position? Well, obviously, the cost of sales and marketing is an expensive endeavor, and there's need for meaningful investment on behalf of the company. You know, if you take a look at our sales and marketing expense, as I referenced, since the beginning of the pandemic, our total expenditure has remained essentially flat with very little fluctuation, and the revenue has continued to increase in spite of that. We have plans in place to begin hiring and growing that team. Of course, we need to stabilize the financial runway of the company first before we start investing again. Those plans are underway. As I mentioned earlier, we'll announce more details as they come into clarity of that financial strategy. A key piece of that financial strategy is giving us the flexibility now to lean into the commercial growth, to position ourselves for acceleration. I think it's very interesting to see you focusing more and more on the drug delivery leg, so to say. I was just wondering if you can elaborate more on the regulatory requirements for these types of indications and how IRRAflow stands. I can talk at a high level. We have not officially engaged either of the regulatory agencies, either our notified body or the FDA in the U.S. about the path forward for label expansion. We're putting the pieces in place to be able to do just that after consulting with our various regulatory experts. Right now the system has a very broad indication and as we gain more clinical experience, we're seeing that physicians are choosing to use some type of therapeutic drug delivery through IRRAflow in a not insignificant percentage of cases. We're collecting a growing pool of clinical evidence about the safety and effectiveness of that approach, and that allows us. We feel that's gonna allow us to have a very meaningful conversation with regulatory agencies about what is required to expand that label. Those conversations we expect to have the first part of this year. You can't really say now if that would be through a 510(k) or a PMA or what type of pathway that would be? Well, I think there's multiple paths that we can take. What we would prefer to do first, and of course, as I said, it's all based on feedback from the regulatory agencies, is right now, you know, IRRAflow, our indications for use mentions irrigation with saline or Lactated Ringer's. Our first step would be working with our clinical evidence thus far to work with regulatory bodies to potentially change that verbiage to irrigation with physician-specified fluids. At this stage of the company, we're not in a position or don't desire to make actual prescribing recommendations. That's up to the physicians themselves. We want to provide them a delivery tool, if you will, a conduit, to allow these drugs to reach therapeutic levels in the brain in a much smaller dose, with much safer outcomes. That's what we're exploring as our first wave. We're also starting to invest more heavily in the drug delivery possibilities, starting to have conversations with potential partners on the biotech and the pharmaceutical side, saying that we have a tool to deliver drugs into the intracranial space. Many of the drugs can't cross the blood-brain barrier. Would IRRAflow be an attractive delivery vehicle? As those conversations progress, we're excited about where they may go. Just one more question before I get back into the queue. Yes, Oskar. Is there any price differences between the IRRAflow 4.0 version and the 3.0 version? It's probably a little too early for us to say that because we've not gotten any, you know, direct commercial feedback yet, so we're just starting to ship them. The initial systems are going to hospitals where we have disposable usage agreements in place in the United States. IRRAS still owns the capital equipment in those facilities, so we'll just upgrade those accordingly. For hospitals that have purchased IRRAflow capital equipment, we'll be discussing with them fees for upgrading to the new technology. There's a meaningful difference in capability and technology, and we're gonna explore every possible avenue to monetize that however we can. All right. Thank you very much. I will get back into the queue. Thank you, Oskar. Thank you. Just a reminder, if you wish to ask a question, please press zero-one on your telephone keypad. There'll be a brief pause while any further questions are being registered. There are no further questions at this time, so I'll hand back over to the speakers. Again, thank you all for attending and for your interest in the Q4 2021 results of IRRAS. We appreciate your support in the company. As I mentioned, we're excited to continue to put our best foot forward in treating patients who are in desperate need of innovative technologies. Every step of the way, we remain committed to keeping those that follow the company and our shareholders updated on all of our progress. Thank you very much, and we hope you have a wonderful day.