Ladies and gentlemen, good morning, and welcome to the IRRAS Q3 earnings call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing star then zero on your telephone keypad. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Will Martin. Thank you, and over to you, sir. Thank you very much, operator. Good morning, everyone. This is Will Martin, President and Chief Executive Officer of IRRAS, and it's my pleasure to welcome you to the IRRAS earnings call for the third quarter of 2022. As we move forward to slide 2 of the presentation, I'd like to note the standard disclaimer that during the course of this presentation, I may be making certain forward-looking statements, and be sure to take that into consideration. Moving forward to slide 3. I'm excited to report to our shareholders that the third quarter was our ninth consecutive quarter of revenue growth as the commercial launch of our product portfolio continues. Revenue for the third quarter totaled SEK 11 million, which was 13% growth quarter-over-quarter from the second quarter of this year and represents 80% growth from the same period one year ago. Growth in both commercial and total system shipments of our IRRAflow unit continues to move forward from previous quarters. During the course of the quarter, our earnings per share was SEK -0.14, down slightly from previous quarters, as the total number of shares did increase during the quarter as a result of the rights issue. Our cash flow from operating activities during the quarter did increase to SEK 57.2 million, but that was clearly related to associated costs from the rights issue, payments that we were catching up on from vendors after the rights issue and an increase in clinical trial activities as well. Moving forward to slide 4, I'd like to highlight significant events that occurred during the quarter. At the beginning of the third quarter, IRRAS established updated financial targets that we'll review in more detail in coming slides. The key events to note during the quarter were financing related. Early in the quarter, we expanded the short-term financing agreement that was in place with our lead investors by another SEK 10 million. It's important to note that total bridge loan amount of SEK 40 million was repaid fully with proceeds from the rights issue later in the quarter. Before the end of the third quarter, IRRAS did complete a fully subscribed rights issue, within which we received SEK 215 million before the deduction of costs and fees related to that transaction. This rights issue allowed us to extend the financial runway, which will allow us to continue to invest in growing commercial adoption of our product portfolio and increasing the comparative pool of clinical data, to document the safety and effectiveness of the technologies that we sell. Finally, during the third quarter, we began patient enrollment in our latest comparative clinical study, the DIVE Study, which is being led by Dr. Christopher P. Kellner from Mount Sinai Health System in New York City, New York. The DIVE Study is evaluating their outcomes with IRRAflow and comparing that to their historic experience within their hospital system for traditional ventricular drainage. On slide five, discussing the key financial data from the quarter. You can see the continued revenue growth quarter-over-quarter, up from SEK 6.1 million a year ago to SEK 11 million during the third quarter of 2022. During the quarter, it's also important to note that the gross margin for the quarter once again dropped to negative as we had a write-off as we increased inventory of our new IRRAflow control unit, our next generation control unit. As we are manufacturing systems that will be placed at U.S. hospitals, as we've done in previous quarters, we did have a one-time write-down for the cost of that inventory. We do still expect the gross margins for the entire year of 2022 to be in line with our established financial targets. As cash flow did increase in the negative side during the course of the quarter, our earnings did also move in a similar direction. At the end of the third quarter, our liquid funds on hand approximated right at SEK 125 million. Moving forward to slide six, like to discuss the revenue growth in more detail. During the quarter, as I've mentioned, SEK 11 million of total revenue was generated. As you can see by the maroon bar, a majority of that revenue, again, was driven by orders coming from U.S. hospitals, although revenue contributions again came from all sectors of our business, including European distributors, our direct German hospitals, and distribution partners in other parts of the world. Thus far in 2022, we have now totaled SEK 29.4 million of revenue north of $3 million, and that compares favorably to the entire revenue generated last year of SEK 22.4 million. On slide seven, continue to see the positive trajectory of overall capital equipment shipments for our IRRAflow system. At the end of the third quarter, we now have 176 IRRAflow systems deployed globally. 87, approximately half of those, have been sold to our growing network of distribution partners. 22 systems continue to support US evaluations, and the number of commercial systems in the US continue to increase as two of our hospitals, Cottage Health in Santa Barbara, California, as well as Northwestern Memorial in Chicago, Illinois, increase the number of commercial systems that are either purchased or placed within their hospitals. On slide 8, I wanted to revisit the rights issue that was completed during the course of the third quarter. As I stated, SEK 215 million was raised as part of a fully subscribed rights issue that will provide working capital to further fuel our company's growth strategy. That working capital will support continued commercial expansion as well as investment in comparative clinical data with our ongoing randomized clinical trials. During the rights issue, 73% of our shareholders elected to participate, which from our perspective confirms the strong ongoing support that we have from key investors. The other 27% was guaranteed through an investment vehicle of Levant Capital, Spectus Investments. They guaranteed 27% of the financing and have now stepped in as one of IRRAS's leading shareholders. On Slide 9, as part of that rights issue process, it was important for us to issue updated financial targets. Those financial targets outline our revenue expectations both for this year and subsequent years. In 2022, at that time, we projected revenue to exceed SEK 35 million with gross margins above 30%. Beyond that point, our expectations are that revenue will continue to grow to exceed SEK 350 million by 2025, with gross margins continuing to improve to above 60%. In conjunction with that, by 2025, our projections are that IRRAS will be cash flow break-even. After the third quarter, once we have completed this financing process and seen that the COVID-19 pandemic would not inhibit continued growth through the rest of the year, we are now comfortable increasing that 2022 revenue projection to at least SEK 40 million. As part of this business update, we also noted that the company will continue to explore all options to increase our commercial product awareness as well as to reduce operating expenses. It's important for investors to appreciate that since the end of the third quarter, we have instituted a headcount reduction of approximately 10% across our organization to both reduce redundancy and better position the company for future growth. Moving forward to slide 10, I wanted to circle back and reiterate that we continue as a company to focus on market leadership in neurocritical care. As many of you are aware, we are a unique Swedish-American commercial stage company with legal headquarters based in Stockholm as well as facilities in Southern California, where a majority of our operations are now located just outside of San Diego. We have a direct sales presence both in the United States as well as key European markets, including Germany and the Nordic countries. Our global warehouse and logistics are based just outside of Amsterdam in the Netherlands as well. On the map, you can see our direct sales territories in the darker blue and our growing network of distribution partners in turquoise now established in many, many markets around the world. On slide 11, it's important to note that this focus upon the neurocritical care market creates a sizable market opportunity for the company. This large addressable market, when one looks at intracranial bleeding, traumatic brain injury, and the opportunity to expand into targeted intracranial drug delivery in the future, offers an addressable market of approximately $7 billion in the European Union and United States alone. On slide 12, you can see the two product families with which we are targeting this large, attractive market opportunity. Our lead product, IRRAflow, the world's first irrigating intracranial drainage system, as well as the complementary product line Hummingbird, the Hummingbird family of intracranial pressure monitoring tools, both allow us to position the company as the leading innovator in the world of neurocritical care. As a reminder to investors on slide 13, IRRAflow is what we like to refer to as a razor blade model. IRRAflow has a small piece of capital equipment, the IRRAflow control unit, that is reused across a number of patients across multiple years, and that is used in conjunction with two disposable single-use components, a dual-lumen catheter that is placed inside the intracranial space to remove excess fluid, as well as a tube set and Intelligent Cassette which controls the fluid exchange process, allowing the neurosurgeon and staff to tailor each patient's treatment with a combination of irrigation and drainage to more efficiently remove collected toxic materials. This combination of irrigation and drainage is controlled based on the patient's condition, their intracranial pressure monitoring, is better seen on slide 14. This combination is a process that we refer to as active fluid exchange with customers. As excess fluid has been collected inside the brain, the IRRAflow catheter helps to control the drainage of that collected toxic material, and it does it through the addition of automated irrigation. The use of irrigation performs two functions. A traditional passive drain, a so-called EVD for external ventricular drainage. These passive one direction catheters can become blocked almost 50% of the time, which causes inefficient drainage, increased risk of infection, and extension of the length of stay in the intensive care unit. IRRAflow's irrigation helps to keep drainage holes free from blockage formation, which you can see in the static image on the slide. The orange catheter is a traditional passive drain, and you can see solid particulates clogging those drainage holes. Irrigation with IRRAflow helps to keep those drainage holes free from blockage formation. The irrigation also helps to dilute the collected blood or any other toxic material that needs to be removed. In the images on the upper right, you can see the thickness, the consistency, the viscosity of collected blood at the beginning of IRRAflow treatment compared to the diluted nature of that fluid after less than 24 hours of irrigation or active fluid exchange with IRRAflow. Dilution of that viscous material ensures that those toxic blood byproducts can be more efficiently removed and that they will clog the catheter much less frequently. It's exciting for me to note on slide 15 that during the third quarter of 2022, we can now report that all of our focused intracranial pathologies with IRRAflow now have peer-reviewed published clinical literature to document that versatility. Across a broad range of intracranial pathologies from subdural hematomas to intraventricular hemorrhage to brain infections such as abscesses or ventriculitis and now to subarachnoid hemorrhages and so-called intracerebral or intraparenchymal hemorrhages, the safe, effective use of IRRAflow has now been documented within clinical literature. During the third quarter on slide 16, it's important to note that Dr. Andrew Carlson and the team at the University of New Mexico Health System published the first clinical literature on the use of IRRAflow for intraparenchymal hemorrhage. An IPH is when an aneurysm ruptures and the blood collects within the brain tissue or the parenchyma itself. This case series by the team at UNM showed multiple cases where the use of IRRAflow in conjunction with thrombolytic irrigation and automated irrigation was able to successfully remove collected blood from within the brain tissue itself within a number of days. During this treatment, the sterility of the system was maintained because of the irrigation. No external manipulation was required. On slide 17, one can see the successful reduction of hematoma volume with IRRAflow treatment. The landmark study when looking at these patients, MISTIE III, showed that functional outcome improvement was only seen in patients where the residual hematoma had a volume of less than 15 milliliters. In that clinical trial, which looked at passive EVDs in conjunction with thrombolytic medication, only 60% of patients were able to achieve that target hematoma reduction. In each patient in this IRRAflow case series, less than 15 milliliters of residual hematoma was seen. In one patient, only 1.2 milliliters of collected blood, 1.4% of the original amount, was left, and in the other, 9.1 milliliters of residual blood was seen. This initial case series paints a very promising picture and establishes a starting point for additional data that will continue to be collected in this severely injured critical patient population. On slide 18, another clinical manuscript was published during the course of the third quarter. The team from the University at Buffalo, which recently hosted a peer-to-peer webinar highlighting their early experience with IRRAflow, that we also promoted widely during the quarter. They published experience with continuous intraventricular irrigation of the antibiotic vancomycin for the treatment of ventriculitis. This clinical manuscript followed up on an earlier ventriculitis manuscript that was published by the team from the University of Helsinki and continues to show the effectiveness of IRRAflow in treating these aggressive brain infections, which traditionally carry mortality rates anywhere from 60%-90% based on previously published literature. On slide 19, circling back to the quarterly results. As I previously mentioned, the total install base of IRRAflow continues to move in the positive direction. After the third quarter, there are now 176 IRRAflow systems that have been shipped globally. That then drives subsequent sales growth as disposables are used to treat patients. Our trailing twelve-month sales development now totals SEK 36.5 million when one looks at the last four quarters of revenue. We've been able to drive that forward progress in terms of revenue growth as shown on slide 20, while maintaining stability in our overall sales and marketing expenses. Since the beginning of 2020, with only a slight reduction during the early stages of the COVID pandemic when travel was restricted, we have increased the size of our sales and marketing team while keeping overall expenses relatively stable. We've done this by increasing the percentage of team members that are focused on education and more judiciously spending our available capital to support customer engagement. While keeping sales and marketing expenses relatively flat, essentially flat since the beginning of 2020, our quarterly revenue has grown anywhere from 8 to 10x, depending upon the quarters for comparison. This is an exciting trend for us, which we expect to continue in coming quarters. We will, again, begin to invest in our commercial resources as we put additional feet on the street to drive demand. It's important for us to continue to see judicious use of capital and increasingly brisk sales growth associated with that. On slide 21, you can see exactly why we continue to be optimistic regarding those trends. During the third quarter of 2022, the percentage of our revenue from the United States that continues to be driven by reorders of disposables after patient treatment continues to be consistent above 75%. This revenue percentage driven by product reorders continues to be driven as we grow our network of key opinion leading surgeon partners. Surgeons from Northwestern, Mount Sinai, West Virginia, Buffalo General, as we've outlined before, are increasingly engaged as we meet with and add new customer partners to this network of thought leaders. On slide 22, again, you can see the specific commercial highlights that come out of these high-level metrics. During the quarter, Northwestern Medicine that we previously discussed being one of the top 10 hospitals in the United States ranking for neurosurgery increased their commercial commitment to IRRAflow by placing an order to purchase IRRAflow capital equipment. Much of our U.S. team's focus during the quarter was training and driving patient treatments at our next wave of evaluations in order to transition them to commercial customers. It's important for investors to note that early in the third quarter, new resident physicians that are being trained rotate into each of these university academic centers, and it's important for our team to make sure that these newest residents who will be responsible for treating patients with intracranial bleeding are familiar with the IRRAflow system. Outside the U.S., exciting progress continued. While we focus much of our energy and effort on our existing distribution partners, our expansion into Asia continued with a stocking order from our partners at a new distribution company in Malaysia was received, and we also received reorders of IRRAflow disposables from several of our European distribution partners. Our launch of IRRAflow within the German direct market continues to expand as we added two additional new disposable orders, one from a new account and one from an existing account that had experience with IRRAflow prior to the COVID-19 pandemic, and we're now also excited that our progress within Denmark continues. We previously have announced our close working relationship with Aarhus University. They're leading the ACTIVE head-to-head comparative study. Now the University of Southern Denmark, another academic teaching institution within Denmark, has begun use of IRRAflow, and they will also be participating and enrolling patients in the ACTIVE study. The third quarter was also an important time for our commercial teams around the world because we were able to again meet in person with customers at key educational conferences. The leading association of neurosurgeons, both in the United States with the Congress of Neurological Surgeons and in Europe with the European Association of Neurosurgical Societies, both held their annual meetings around the end of the third quarter and early into the fourth quarter. CNS 2022 was held in San Francisco, and EANS 2022 was held in Belgrade, and it was an exciting opportunity for clinical data to be presented, for our sales teams to engage face-to-face with current and prospective customers, and for our physician partners to speak to their peers with educational presentations within our exhibit hall booth. In addition, we also, during October, participated in the Neurocritical Care Society annual meeting that was held in Texas in the United States. On slide 24, I'm pleased to be able to highlight one of the clinical posters that was presented during these meetings. During the Congress of Neurological Surgeons annual meeting, physicians from the University of Helsinki, Martin Luther University of Halle-Wittenberg, and West Virginia University in the United States presented their early experience to more effectively remove collected blood from patients suffering from subarachnoid hemorrhages. These patients traditionally suffer from an exceedingly high percentage of shunt dependency, where a secondary surgery is required to facilitate effective movement of cerebrospinal fluid moving forward. Essentially, collected blood collects and clogs communication channels where cerebrospinal fluid moves freely between the brain and the spinal column. During the clinical study, it was noted that out of 15 patients suffering from SAH that were treated with IRRAflow, only two of them required a subsequent shunt to be placed, significantly lower than the percentages expected during the predictive analysis that was done during patient follow-up. The FASH study, which will be a randomized prospective study led by University of Helsinki and Lenox Hill Hospital in New York City, will begin looking at the effectiveness of IRRAflow to treat subarachnoid hemorrhage and reduce vasospasm. We'll look at that in more detail with hopes that that will begin enrolling patients during the fourth quarter of this year. Finally, on slide 25, I want to circle back around and reiterate the key investment thesis that drives IRRAS forward and hopefully will continue to add shareholder value. Not only do we continue to treat a sizable addressable market for intracranial bleeding and traumatic brain injury, it's important to note that established standards of care are outdated and have subpar outcomes that are well documented in clinical literature. Our innovative products now have limited product development and regulatory risk. They're commercially available and are being adopted by a broader, increasing group of important customers with supporting clinical data growing each and every day. Our dedicated direct sales team, both in the United States and key European markets, combining with a growing network of distribution partners, to ensure that an increasing number of patients are treated and helped with our technologies each month. Our business model continues to be attractive with the growing install base, with an established trend of disposable reorders that allow high-margin consumables to drive a majority of our business. Now, with our latest financing efforts behind us, our focus moving forward continues to be on commercial expansion and clinical data generation to allow our growth to accelerate. With that, I'll hand it back over to the operator to answer any questions that, any of the participants in today's call may have. Thank you very much for your continued support of IRRAS, and we're pleased to be able to present our results from the third quarter to you this morning. Operator? Thank you very much. We will now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. The first question comes from Oscar Bergman from Redeye. Please go ahead. Good morning, Will. Or good night maybe. It's late for you in the U.S., I know. I have a few questions, and I guess I'll just take them one by one. Sure. The first one relates to the staff reduction of 10%. I'm just wondering if you could elaborate on what parts of organization and then what timeline for this staff reduction and if you are looking into other actions to reduce costs? Sure, Oskar. I would say that from a focus on the staff reduction piece, as we've spoken previously about, we're constantly looking at the appropriate way to position IRRAS to support our future growth. A number of functions across the organization were impacted, including our commercial operations group, our operations group, our information technology group. It wasn't just one particular area. I think we looked at the organization as a whole, identified areas where we felt we had redundant resources, and areas that we wanted to refine our approach moving forward to be better prepared for our next wave of growth. These actions have already been implemented, and we would expect to see some level of operating expense reduction in coming quarters. Okay. If you look at U.S. sales, you started to get some nice traction there. I'm wondering if you could elaborate on how many centers make up these figures and if any center makes up a particularly high percentage of total sales or just how the dynamics look like. Sure. We're still in a position where we're not going to identify specific account totals or specific account contributions, out of respect for the confidentiality of our customers. What we can say is that our base of commercial customers continues to grow. As I mentioned during the quarter, two of our evaluation customers, Cottage Health as well as Northwestern, transitioned into commercial customers. We're excited by the trending, where we're seeing customers exploring the possibility of capital equipment purchases, which we saw from Northwestern during the quarter, as they want to expand the number of IRRAflow systems available to treat patients. There's a broad mix of contributions between these commercial customers, which generated more than 75% of our U.S. revenue through their reorders, as well as a handful of additional evaluations that got started during the quarter. Although during the third quarter, more of our team's focus was on ongoing evaluations as opposed to bringing new evaluations into the funnel. Okay. All right then. On OpEx, I'm wondering if you can elaborate also on the R&D expenses going forward. Is this figure in Q3 more of a baseline for the coming quarters, or was it particularly high due to the clinical trial startups, or can you give some background? Yeah, no, I definitely would say that the increase we saw in the third quarter is not a new baseline. Now of course, we are spending more on clinical trials than we have in previous years. Our plan is to more clearly outline that increased spend in coming quarters as we have additional data points to share. I would say that the increased spend during the third quarter was attributed to catching up on vendor payments that had been spread out during the course of the financing process, as well as some of the startup costs for the DIVE, the ARCH, and the ACTIVE study, which we've explained to our shareholders previously. For a few quarters now, you've done some write-downs in the cost of goods sold. Yes. Just wondering also if you can just explain that going forward. Are we expected to see more write-downs in cost of goods sold, or is that more or less cleared now? Well, it's something that's come up a couple of times, primarily because of the percentage of control units that we are manufacturing but are ultimately planning to be placed without being purchased by U.S. customers. By the fact that we've manufactured those and expect to place them, we've written those down at a variety of quarters in the past to offset the cost that's within inventory. Our expectation now that we're seeing a larger focus from customers on purchasing the capital equipment is that those write-downs would not be as needed in the future, and we're also finalizing our upgraded disposable products, which will have extended shelf lives. We expect by the middle portion of next year, the shelf lives on all of our IRRAflow disposables to move from a 12-month shelf life to a 36-month shelf life, which will also Okay prevent us from having to write off as many potentially expired products as we've had to do in the past. That shelf life extension and selling more capital equipment to U.S. hospitals, from our perspective, will help to eliminate the possibility of such write-downs in the future. All right. You have the registration in Germany. That's a market where you've been active in before. It's still a pretty slow ramp up there I see on the report. Can you explain what's going on there and how you will make sure to see some traction there as well? Yeah. The growth that we are seeing, the activity growth that we are seeing in Germany is encouraging. But it's still in the formative stage of transitioning evaluations into long-term repeat commercial business. We now have a number of German hospitals that have purchased disposables over the last several quarters that are currently evaluating the product. Based on response and based on reaction from other facilities throughout the country, we're encouraged by the progress that we're seeing, and we're optimistic that the contribution from Germany will move beyond these initial evaluations into more realistic revenue contribution in coming quarters as we start to see not only more disposable reorders, but also associated capital equipment purchases. We also have been working diligently behind the scenes on collecting necessary data to support German add-on reimbursements for the IRRAflow system. Obviously, once that is completed, then that will help to fuel additional adoption across the country as well. We're behind where we are in the U.S. just due to the previous CE mark delays and extended impact from COVID-19. We are encouraged by the number of ongoing evaluations as a leading indicator for contribution that we expect in the future. Good. This is maybe a very speculative question that you can't give much of an answer to, but in relation to or in regards to your financial targets, how crucial is the German market? I think all of our markets are crucial. Without getting too speculative, as you mentioned, you know, if you go back to our early stages as a publicly traded company, Germany was leading the way as our first commercial market. That flip-flopped with the United States as we went through the CE mark transition. We still have extremely high optimism for the contribution that Germany will have to our total revenue growth. You know, we need to be, and we plan to be successful in Germany to drive ourselves towards those forward-looking revenue targets. We're increasingly happy with the activity that we're seeing there now post-COVID. Good. Just a final question, Will, before I'll get back into the queue. Hummingbird, Yeah Can you elaborate on the progress of that product and your focus on the expectations going forward? Yes. Hummingbird continues to be an important part of our portfolio. It is and will remain secondary to IRRAflow as we see IRRAflow in its adoption and its revenue contribution continuing to drive a majority of our activity and our business. Hummingbird is still only approved in the United States, and with all of the backlog of technical files that are being reviewed in Europe under MDR, we are prioritizing the CE mark extension of IRRAflow under the new European guidelines first. Hummingbird will, you know, still be delayed slightly for introduction into Europe until after the IRRAflow upgrade is completed. We have a couple of new customers that are evaluating the product in the U.S. and as we engage customers here, we expose them to both IRRAflow and Hummingbird. As a new company, oftentimes they can only evaluate one product at a time, and they generally decide to start with IRRAflow and then expand to Hummingbird from that point forward. That's generally what we support as well, simply due to the price point differences between the two product lines also. All right. Thank you very much, Will. Thanks, Oscar. As always, I appreciate the questions. Thank you. Again, if you have a question, please press star then one. This concludes our question and answer session. I would like to turn the conference back over to Will Martin for closing remarks. Thank you very much. Again, I'd like to thank everybody for their focus and participation in this conference call to discuss IRRAS's results for the third quarter of 2022. As you can see in the final slide that's on your screen, we encourage you to follow us closely and connect with us either via our IRRAS Academy mobile application or any of our social media platforms across LinkedIn, YouTube, Twitter, or Instagram. We are always updating our customers and our investor community on the exciting progress that we're seeing, and we would love to have you follow along. Thank you very much for your interest in IRRAS, and look forward to speaking with all of you again soon. Have a great day. Thank you. Ladies and gentlemen, the conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines.