Welcome to the IRRAS Q1 2023 report presentation. For the first part of the presentation, participants will be in listen-only mode. During the questions and answers session, participants are able to ask questions by dialing star five on their telephone keypad. I will hand the conference over to the speakers. CEO Will Martin, please go ahead. Thank you very much, moderator. Good afternoon, everyone, thank you for joining the IRRAS first quarter 2023 interim report presentation. I'm Will Martin, President and Chief Executive Officer of IRRAS, I look forward to sharing our company's recent successes and progress with you today. As always, I'd like to start with the standard forward-looking disclaimer. During today's presentation, I may make certain forward-looking statements. Please assess those accordingly. Starting for the first quarter of 2023, it's important to note, as I'm sure many of you have noticed, we have redesigned the IRRAS quarterly report. We've condensed its format, trying to make the information more focused, and easier to understand for shareholders. During the first quarter of 2023, our performance was highlighted by revenue of SEK 11.2 million. That represents 30% revenue growth from the first quarter of last year. 83% of our first quarter revenue was generated in the United States, which shows a notable increase over the same period last year, as well as all of 2022. During last quarter's report, the final report for 2022, we did stress that we expected more of our revenue to be generated in the US due to the maturity of the product launch in the market, as well as our growing commercial partnership with Medtronic. During the course of the first quarter, 81% of IRRAS' total revenue was generated by reorders from existing customers. That percentage also shows a notable increase from the first quarter of last year and all of 2022. It's especially notable to highlight that 95% of our revenue driven in the United States during the first quarter was generated due to reorders from disposable products. During the course of the first quarter, the total global IRRAflow install base continued to grow, up from 184 last quarter to 188, with a similar increase in the number of commercial systems in the US, up from 30 during the same period last year and 44 last quarter, now at 46. Our cash flow for the quarter showed slight improvement from the fourth quarter at -50.7 million SEK. That's a key area we'll continue to focus on moving forward to extend our cash runway. On the next slide, highlighting again the 11.2 million SEK of revenue. This was generated with a gross margin of 8%. It's important to highlight that gross margin was down from previous periods, but this really does reflect the company's shift from being a development organization to some degree, to one that is fully focused on commercialization. During the course of the quarter, we were focused on building up inventory to support increased customer utilization and an increased number of customers, particularly as the activity of our partnership with Medtronic continues to increase. Moving forward, as sales volumes grow, the expectation is that our cost of goods sold will not grow at the same rate and will continue to improve and move forward to our previously stated goals for margin attainment in the future. Our cash flow, as previously mentioned in the last slide, was negative SEK 50.7 million, leaving us with liquid funds at the end of the period of SEK 17.6 million. While the process is not finalized yet, we are actively involved in securing the company's next wave of financing, and the available cash for working operations, for working capital, also has been boosted by a bridge loan up to SEK 40 million by our lead investors, and we'll discuss that more in coming slides. During the course of the first quarter, our revenue was driven, as previously mentioned, by increased contribution from the United States market. The total revenue of SEK 11.2 million had 83% of it generated from the United States, as evidenced by the maroon or dark orange bar on the slide being shown. Moving forward, we continue to expect that the US will drive a similar portion of our revenue, particularly as we move through the course of the year and an increasing portion of that revenue is driven via the Medtronic partnership. Our global install base of IRRAflow continues to increase, now up to 188. 21 systems continue to support evaluations at hospitals in the United States. Forty-six systems are now placed commercially, meaning that evaluations have successfully been completed and product is used in a recurring ongoing manner to generate commercial revenue. Similar numbers outside the US, 30 systems with direct commercial customers and 91 systems having been sold to our distribution partners as their commercial activity and patient treatments continue to increase. During the course of Q1 and the period of time since the end of Q1, there are a handful of significant events I'd like to discuss in more detail. First of all, the first comparative clinical data confirming the superiority of treatment with IRRAflow compared to traditional passive drainage was published, as well as the short-term financing agreement of 40 million SEK. Starting with the short-term financing agreement, IRRAS has secured that bridge loan with Bacara Holdings, our second-largest shareholder, which is led by our chairman of the board, Marios Fotiadis. This bridge loan will provide us up to 40 million SEK through the course of this summer to cover working capital needs as we work to complete the ongoing financing process, which we expect to provide more detail in coming weeks. Regarding the published clinical literature, in the peer-review journal Operative Neurosurgery, the surgeons from the University at Buffalo and Buffalo General Medical Center, led by Dr. Adnan Siddiqui and Dr. Elad Levy, two of the most recognized and respected thought leaders globally in the world of neurosurgery. Their team in Buffalo published a manuscript entitled Use of Novel Automated Active Irrigation with Drainage versus Passive Drainage Alone for chronic subdural hematoma, A propensity score-matched comparative study with volumetric analysis. In this manuscript, it was demonstrated that IRRAflow treatment resulted in statistically significant improvement in outcomes regarding improved hematoma clearance rate, meaning that treatment with IRRAflow resulted in faster removal of collected blood inside the intracranial space. Statistical analysis showed that this outcome had almost a 98% statistical significance, meaning that could be repeated almost 98% of the time. In addition, IRRAflow was also shown to result in a lower rate of catheter-related infections. The statistical significance of these outcomes demonstrated that they could be repeated more than 96% of the time. In addition to those statistically significant outcomes when comparing the active and the passive drainage arms, it was also shown that the use of IRRAflow resulted in a trend towards significance for the length that the catheter was placed, the period of time that the patient stayed within the hospital, and the overall amount of seizure activity, which is a noted side effect of a chronic subdural hematoma. For these outcomes, the statistical analysis showed that significance could have been reached if a larger set of patients had been treated. This clinical manuscript is critically important in our commercial growth activities as it's the first time that a head-to-head comparative clinical study has been published in a peer-review journal documenting the improvements in outcomes and patient impact from the use of IRRAflow's Active Fluid Exchange. We're excited that multiple other clinical studies in a similar fashion are expected to be published in coming quarters. Such awareness, clinical data generation, and overall commercial adoption growth are the key areas of focus for IRRAS throughout 2023. Driving adoption and clinical usage of that increasing global install base, expanding in the United States as our partnership with Medtronic has broadened our US footprint, and continuing to grow and build a solid commercial foundation by focusing on our active direct markets and our established distribution partners in Europe. Expanding the clinical body of evidence with these types of comparative clinical manuscripts, as well as reaching interim analyses with multiple ongoing clinical trials. All the while, taking the investment to date in our inventory and infrastructure, and as sales grows, translating that into further improvements in our overall gross margin. These will be the key areas of focus that will drive the success of IRRAS throughout the remainder of this year. I wanted to also reinforce and remind you of our company's key area of focus. IRRAS has a comprehensive portfolio of products focused upon neurocritical care. These are the sickest patients in the neurosurgical intensive care unit, typically suffering from intracranial bleeding or traumatic brain injury, which we help treat with our IRRAflow product as well as the Hummingbird family of intracranial pressure monitoring tools. Our main focus as an organization at this point is the commercial rollout and increasing customer adoption of IRRAflow, the world's first irrigating intracranial drainage system. That neurocritical care market is one that is sizable and attractive. In intracranial bleeding and traumatic brain injury alone, looking at the number of patients treated annually, multiplying that by our average selling price leads to a market that we assess at approximately $2.4 billion just in the U.S. and Europe alone. Approximately 50% of our patients at this point are treated with some type of therapeutic drug irrigation with IRRAflow. As we expand further into this market opportunity, the total addressable market will go up accordingly. Over the last quarter or so, we have seen new market research that indicates that there also may be significant upside opportunity in the external ventricular drainage market. A recent market research report by Precedence Research estimated that the global market for passive EVDs was $2.64 billion in 2021 and projecting it to grow at more than 5% annually to north of $4 billion by the end of this decade. With IRRAflow's premium price point compared to traditional passive drainage, we feel that these new market numbers may indicate a significantly larger market opportunity for the company, and we're digging through this research report in much more granularity and we'll update our adjustable market estimates moving forward accordingly. The IRRAflow system is made up of three components: the IRRAflow Control Unit, to which the IRRAflow Tube Set and Intelligent Digital Cassette are attached, and then the IRRAflow dual lumen catheter, which is placed inside the patient's brain. This results in a traditional razor-razor blade model for our go-to-market strategy. We're working to place as many of the small pieces of capital equipment, the IRRAflow Control Units, at customer locations, which then can drive increasing utilization of the two other components, the Tube Set and Catheter, which are single-use disposable components. IRRAflow works through a mechanism of action that is known as Active Fluid Exchange. Whereas traditional External Ventricular Drains only provide passive gravity-driven drainage of excess fluid, IRRAflow's Active Fluid Exchange combines not only that controlled fluid drainage, but also combines it with recurring automated irrigation and continuous monitoring of the patient's intracranial pressure. Whereas a traditional passive EVD, such as the orange catheter shown on the screen, with traditional passive EVDs, solid particulates begins to collect on the distal tip of the catheter and can begin to occlude drainage holes very quickly upon placement. With IRRAflow, the use of automated recurring irrigation flushes the distal tip of the catheter, dislodging any adherent clot formation and keeping drainage holes free from blockage formation. That irrigation helps to disrupt and dilute collected toxic material. In the images you see on the right side of the screen, the thick, viscous blood that starts at the beginning of patient treatment over time becomes diluted and easier to remove by IRRAflow's irrigation. This helps to address one of the main complications of passive EVDs, which can become blocked almost 50% of the time. IRRAflow's irrigation has been designed to disrupt the possibility of that clot formation and eliminate the possibility of catheter occlusion. This active fluid exchange mechanism of action has now been documented in peer-reviewed journals across a broad variety of treatment pathologies. The versatility of IRRAflow has been shown in the treatment of chronic subdural hematomas, which is a collection of blood between the brain and the skull, typically after a fall. It's been assessed in the treatment of both intraventricular and intraparenchymal hemorrhage, where active bleeding occurs in the brain and blood collects either within the brain tissue or within the ventricles, which are the reservoirs of cerebrospinal fluid deep in the brain. The system has also been shown to be effective in washing out infected areas within the brain, either after surgical abscess removal or when aggressive bacteria begins to colonize within the ventricles as well. The combination of irrigation and drainage, particularly if therapeutic drugs are incorporated in the irrigation, has now been published in peer-reviewed journals to document the ability of the system to impact patient outcomes. Our company's commercial team and distribution partners remain focused upon executing upon that razor-razor blade model. An increasing number of global installations of IRRAflow capital equipment continues to drive increased total revenue as more disposable single-use kits are used to treat patients. The overall revenue also continues to be heavily driven by commercial reorders, particularly in the important U.S. market, driven by a key opinion leader network that is growing and strengthening as we work more closely with our key reference centers. A large percentage of our U.S. revenue continues to be driven as these customers reorder disposable IRRAflow kits. In the first quarter, 95% of our total U.S. revenue was driven by these commercial reorders. In coming quarters, we expect that commercial reorders will continue to drive a similar percentage, a high percentage of U.S. revenue. As more customers move into the evaluation phase or complete their evaluations and turn into commercial customers, we still will see some ebb and flow of this based on the impact that such stocking orders can provide. During the first quarter, our team was also able to engage in person with customers at the American Academy of Neurosurgery annual conference that was held actually just after the end of the first quarter in Los Angeles in April. In conjunction with our partners at Medtronic, we held a well-attended physician engagement event where Dr. Nicholas Brandmeir from West Virginia University shared his clinical experience with IRRAflow. We also were able to meet in person and make important progress to engage key customers at a number of new impactful targets across the United States, secure physician commitment to support product approval, and continue to strengthen our overall sales funnel. At the AANS annual meeting, a number of clinical posters were presented, including one from Dr. Behnam Rezai Jahromi from University of Helsinki that showed a reduction of secondary surgery need and a significant reduction of shunt dependency after the use of IRRAflow to treat subarachnoid hemorrhages. Of the 15 patients treated in this patient series, only two required shunt placement after IRRAflow, showing that the system's Active Fluid Exchange was able to sufficiently remove toxic blood byproducts to minimize the need for that secondary surgery. Additionally, the team from Buffalo General Medical Center also presented their initial glimpse at comparative data for the treatment of intraventricular hemorrhage. Much like their clinical manuscript that I discussed earlier that compared the use of IRRAflow and external ventricular drains to treat chronic subdural hematoma, the group has also assessed similar comparative outcomes for the treatment of intraventricular hemorrhage, their poster concluded that the use of IRRAflow was safe and resulted in better clearance of ventricular blood compared to a standard EVD. Both of these posters provided an early glimpse at clinical data that is now being prepared for publication in peer-reviewed journals. During the course of the 1st quarter of 2023, it was another important quarter in this growth and progression of IRRAS. Obviously, we are in the process and expect in coming weeks to announce our company's next needed financing that will provide working capital moving forward to continue to build uponGrowing commercial use of our products. Such a successful financing will allow us to build upon the 1st quarter of 2023 and continue to execute upon our key investment thesis. We're targeting a sizable market where the treatment of intracranial bleeding remains heavily dominated by the use of outdated subpar technologies. With recent analyst reports, we're assessing at whether this market may be even larger and more attractive than we first assumed. Our innovative product portfolio now has the capitalization of our research and development products completed. We've shifted into full focus upon commercialization now that the product development and regulatory risks have largely been removed as an organization. During the course of this year, we will submit our next generation disposables for regulatory clearance approval, both in the U.S. and Europe, that will allow us to now further accelerate and further validate the impact of these products, both through commercial adoption and clinical data generation. Our team, our direct sales and education team, combining with our commercial partnership in the U.S. with Medtronic and our network of distribution partners globally, are focused on executing that razor-razor blade model, driving the global growing install base to result in increased disposable utilization. Our focus shall remain as we move forward on commercial execution and expansion. The key investment thesis hasn't changed, and we will continue to execute upon it accordingly. IRRAS is extremely active through various online and social media channels. We encourage investors to stay close and stay updated to our progress via downloading the IRRAS Academy app and following us whether it be on LinkedIn, Twitter, or our YouTube channel. As always, we will keep everyone updated on our progress via press releases and other proactive investor communications. Thank you for your time today. Thank you for your continued interest in IRRAS. With that, I'll pause, hand it back over to the moderator, and answer any questions that any participants may have. If you wish to ask a question, please dial star five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial star five again on your telephone keypad. As a reminder, if you wish to ask a question, please dial star five on your telephone keypad. There are no questions at this time, so I hand the conference back to the speakers for any closing comments. Thank you very much, moderator. Q1 was another important step in the growth and development of IRRAS as an organization. We expect to continue to be able to demonstrate that growth through the course of this year. In coming weeks and months, we will continue to communicate and share that progress with you every step of the way. Thank you for joining us today. Thank you for your continued interest in IRRAS, and we look forward to speaking with each of you soon. Have a great day.
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