Welcome to the IRRAS Q4 Report Conference Call. For the first part of the conference call, the participants will be in listen-only mode. During the questions and answer session, participants are able to ask questions by dialing star five on their telephone keypad. I will hand the conference over to the speaker CEO Will Martin. Please go ahead. Good afternoon. Welcome to The Q4 2022 and Year-end 2022 Annual Report Presentation for IRRAS. My name is Will Martin, President and Chief Executive Officer, and I'm excited to share with you the continued progress of our IRRAS team. Start with the standard disclaimers. I may at certain points during this discussion make certain forward-looking statements. For the year-end 2022, the financial highlights of the organization are noticeable. During the fourth quarter, our revenue traction continued with SEK 10.6 million, which is up almost 50% year-over-year from the fourth quarter of 2021. As outlined to investors earlier in the year in our financial targeting, our year-end revenue came in right at SEK 40 million, almost 80% year-over-year growth. That revenue growth continues to be driven by increased commercial utilization across the world. In the United States, our number of commercial systems continues to grow, up to 44 at the end of the year, and the total number of IRRAflow systems shipped globally now stands at 184 at the end of the year. Our earnings per share continued to move in the correct direction during the fourth quarter, and even with continued increased commercial activities, our cash flow improved from the third quarter as well. Looking at the numbers in even more granular detail, you can see the overall positive trends across the board. Revenue for the entire year of 2022 stands at SEK 40 million with a positive gross margin of 21%. During the fourth quarter, that returned back to positive territory. As referenced for on the last slide, earnings per share improved during the fourth quarter and also continued to show positive trending for the entire year 2022. It is important to note at the end of the fourth quarter, at the end of the year, our overall available funds were at SEK 69.3 million. We will continue to keep investors updated on our plans to address that matter. During the fourth quarter, our revenue of SEK 10.6 million, which again represents 48% year-over-year growth, was heavily driven by continued progress in the United States. Almost SEK 8 million of revenue was driven by U.S. commercial customers. This was the third consecutive quarter, on a U.S. dollar basis, that we exceeded the $1 million threshold. Revenue contribution from direct hospitals in Germany and our distribution partners globally also contributed to the total revenue number. As referenced in the written report, our focus during the quarter and moving forward will be more on driving traction and adoption in these direct accounts and our existing distribution base. For the first time in a number of quarters, we did not add new international distribution partners for revenue contribution during the course of the quarter. As referenced, the overall IRRAflow install base continues to trend in the right direction, up to 184 at the end of the year. We view global install base as a meaningful forward-looking indicator, meaning that we have more systems available to drive patient treatments, which ultimately will drive more commercial revenue as disposables are utilized. Of the 184, approximately 20 still supporting ongoing U.S. evaluations. As customers are converted from evaluations to commercial customers, the number of commercial systems continues to increase. During the course of the quarter, the number of systems with European direct customers increased, and we remain relatively consistent with the number of systems that have been sold to our distribution partners. We would expect these trends to continue in coming quarters as well. During the course of the quarter, it really was an exciting and what we deem to be transformational period for IRRAS. Most importantly, during the fourth quarter, a commercial partnership with Medtronic was signed and then initiated. We'll discuss that commercial agreement in more detail in coming slides. This is particularly important because Medtronic, as the world's largest medical device company. Now gives IRRAS and our IRRAflow system increased commercial presence, increased number of feet on the street to drive awareness and drive commercial adoption in the United States, the world's largest market for neurosurgical procedures and neurocritical care. During the fourth quarter, we received United States 510(k) clearance for our next generation IRRAflow Control Unit. This product's being extremely well-received in the marketplace. The upgrades with the new system include enhanced interactive software as well as a new design for the drainage collection system, and now the capability for data to be transferred from the IRRAflow system through the patient's bedside monitoring system to the central nursing station in the intensive care unit. Finally, during the fourth quarter, our ability to engage customers and drive peer-to-peer neurosurgeon interaction continued to move in the correct direction. We participated in a number of global neurosurgical conferences with increasing numbers of clinical data being presented. Of note, at the Congress of Neurological Surgeons annual meeting, Dr. Behnam Rezai Jahromi from Helsinki presented his poster that showed significant reduction of follow-on shunt surgery due to inefficient blood removal with the IRRAflow system. Using IRRAflow, more blood was removed from the patient, meaning that only two out of the 15 patients tracked required that additional surgery. Finally, a very important educational webinar series with the physicians from Buffalo, New York, led by Dr. Adnan Siddiqui, was initiated. This webinar series allows a number of leading neurosurgeons to share their expertise on intracranial bleeding and, more importantly, their experience to date with IRRAflow and how it's changing their treatments algorithm. Let's talk about the Medtronic partnership in slightly more detail. We've now initiated a sales partnership. We're in the pilot phase with Medtronic, and an initial number of Medtronic territories now have, within their geographic areas, the exclusive right to commercialize, promote, and solicit sales of IRRAflow. Essentially, what this means is that Medtronic will sell the product using their existing sales force, and IRRAS and our team of clinical nurse educators will remain responsible for training, clinical case support, and both teams will work very closely together to increase the adoption of the IRRAflow system. As the partnership matures, as we move beyond this initial pilot phase, we'll stay in close contact with our partners from Medtronic, and we'll continue to explore the possibility of expanding the partnership and increasing the number of territories where their team promotes the IRRAflow system. Over the last several years, we've talked extensively about our hybrid model, where we have direct sales professionals in the key markets of the United States, Germany, and the Nordic countries, and then we utilize a network of distribution partners in other countries around the world. As we navigated the COVID-19 pandemic, the growth of our commercial team, particularly in the United States, fell behind the size that we originally projected in our models. With limited access to customers and future uncertainty due to the pandemic, we were extremely judicious in increasing the size of this team. This partnership will now allow us to make up for lost time. This allows IRRAS to accelerate the product launch, to have an increased field presence, while also being judicious about increasing the cost associated with such an expansion. Already, this partnership has more than doubled the size of our U.S. sales presence that is promoting IRRAflow. As the Medtronic team makes progress with their customer relationships, we expect to see the associated revenue contribution in coming quarters. From our perspective, most importantly, this partnership provides a significant validation of the impact that our IRRAflow system is making in the neurosurgical intensive care unit and a validation of the hard work and progress that our entire IRRAS team has made over the last several years. The other key element that I wanted to discuss in more detail is actually a key event that's happened since the end of the fourth quarter. Earlier this month, the team from Buffalo, again led by Dr. Siddiqui, as well as Dr. Elad Levy, the current President of the Congress of Neurological Surgeons, published the first comparative IRRAflow study versus traditional passive external ventricular drainage. This clinical study was published in the Operative Neurosurgery peer-reviewed journal, and it looked at the use of IRRAflow to treat chronic subdural hematomas. 21 IRRAflow patients that were suffering from chronic subdural hematoma were compared against 35 similar patients that were treated with external ventricular drainage. What the clinical manuscript showed was that IRRAflow treatment resulted in statistically significantly improved outcomes in two key endpoints. First of all, the use of IRRAflow significantly improved the rate of hematoma clearance. In other words, blood was removed at a faster, more efficient, more thorough rate with IRRAflow. The statistical analysis showed that this outcome would be repeated almost 98% of the time in any future clinical studies. With IRRAflow, 0.5 ± 0.4 milliliters of blood were shown to be removed per day, which was significantly superior to the rate of drainage with a passive EVD. In addition, the use of IRRAflow and its irrigation and active fluid exchange mechanism of action resulted in a statistically significant lower rate of catheter infections. Infections are a significant adverse event associated with intracranial drainage that significantly adds cost and length of stay to the procedure. With the irrigation associated with IRRAflow and the lack of needed external manipulation, it was shown in this clinical study that IRRAflow reduced the rate of those infections. Again, the statistical significance confirmed that this outcome would be repeated more than 96% of the time in future clinical data collection. Furthermore, the outcomes of this study showed a trend towards statistically significant improvements with IRRAflow. There weren't enough patients to reach true statistical significance, but the clinical data showed that in terms of catheter placement, duration, overall patient hospital length of stay, and seizures, which is a significant side effect of chronic subdural hematomas, that IRRAflow was trending towards improved outcomes in each of these categories as well. From an IRRAflow standpoint, this clinical data is the first step of many that we are aggressively pursuing to confirm the superiority of the IRRAflow system. This clinical data has been very well received by our customer base thus far, we're excited to build upon this with further comparative data throughout the course of 2023 and beyond. This sets the stage for what we as a company will focus upon for the remainder of 2023. It builds upon each of these key parameters. First and foremost, we will continue to drive awareness and clinical adoption of IRRAflow, resulting in continued revenue growth. We'll take advantage of the growing global install base to drive additional disposal utilization and revenue. We expect that our partnership in the United States with Medtronic, that we can take advantage of the significantly broadened footprint. Our focus in Europe will shift from not adding new distribution partners, but to driving adoption in our direct markets and our established distribution markets moving forward. In addition, we want to build upon, we plan to build upon this comparative clinical data by further expanding the body of clinical evidence supporting our products. Other comparative clinical manuscripts are now being generated for publication, and we're excited by our physician partners being able to document and share that information with their peers. Furthermore, as we've discussed, led by the ARCH study, we have multiple clinical trials ongoing that are prospective, randomized, and comparative that will have interim data readouts in coming quarters to further drive the pool of evidence. All the while, our plan is to continue to drive this growth in the appropriate manner that allows our gross margins to continue to improve. For those that are newer to the IRRAS story, I'd like to take a step back and give you a little bit more added context to who we are as a company. IRRAS is a Swedish-American commercial stage company focused on innovation in the world of neurocritical care. These are the patients that are critically ill, treated by neurosurgeons, and staying in the neurosurgical intensive care unit. Our company is headquartered in Stockholm with a unique presence both in Europe as well as the United States. Our executive team and manufacturing operations are based here in San Diego, California. We have a direct sales and education presence in the United States, in Germany, and in the Nordic markets with our European distribution hub being located just outside of Amsterdam in the Netherlands. As I mentioned, we're focused upon innovation in the world of neurocritical care. This creates a meaningful market opportunity for us in our initial areas of focus, intracranial bleeding and traumatic brain injury. This is more than a $2 billion market just in the European Union and United States alone. Looking forward, we've seen in early clinical utilization the effectiveness of our system in delivering targeted therapeutic drugs directly to the needed site of treatment in the brain. Moving forward, we'll focus on exploring avenues to expand our label towards this targeted drug delivery. As we're able to do that exponentially increases the market opportunity. We're launching two products, primarily led by our IRRAflow system, which is the world's first irrigating intracranial drainage system, as well as the complementary product, the Hummingbird family of products for intracranial pressure monitoring. Of note, the IRRAflow system consists of three components. It's what we call a razor-razor blade model. There's a small piece of capital equipment, the IRRAflow Control Unit, that is attached to two single-use disposable elements, the IRRAflow tube set and digital pump, as well as the IRRAflow dual-lumen catheter that is placed inside the patient's brain to remove excess toxic material, such as blood or bacteria colonies. The system works in a cyclical fashion where automated irrigation, controlled drainage, and intracranial pressure monitoring are repeated in a recurring fashion. This irrigation serves two purposes. First of all, it keeps drainage holes free from blockage formation, and it also helps to dilute the collected toxic material, making it easier to remove. The cycle portion for controlled drainage removes that toxic material that's been diluted, and that's followed by a period of intracranial pressure monitoring where the patient's condition is confirmed and treatment is adjusted based on that evolving patient condition. This irrigation is critical because almost 50% of the time, passive external ventricular drainage can become blocked, compromising life-saving fluid removal. The pictures on the right of the screen, again, show the impact of that irrigation. The picture on the left shows dark, viscous blood after a treatment for a chronic subdural hematoma has begun. That thick, viscous blood very quickly can clot and occlude a passive drain. In the IRRAflow picture on the right, you can see the difference in coloration of the drained fluid. The IRRAflow irrigation has broken up and diluted the collected blood, ultimately making it easier to remove. That irrigation and drainage combination has shown itself to be an extremely versatile treatment for all sorts of intracranial pathologies. We now have peer-reviewed data published for all of these potential treatment pathologies with IRRAflow. From chronic subdural hematomas, which are collections of blood between the brain and the skull, to intraventricular hemorrhage, where blood collects within the cerebrospinal fluid reservoirs within the brain, to bleeding within the brain tissue itself, subarachnoid hemorrhages, and aggressive brain infections. The IRRAflow system has proven its ability to significantly help these ill patients. Moving forward, our commercial plans are to continue to expand the number of IRRAflow systems that are installed globally. As there are more systems, more patients can be treated, and that ultimately drives continued 12-month sales growth, which over the last three calendar years now has grown from SEK 7 million annually to SEK 40 million annually. This increasing revenue continues to be driven by strong product adoption in the United States by an increasing number of thought-leading physicians. For the 5th consecutive quarter, our U.S. revenue, more than 70% of our U.S. revenue has been driven by disposable reorders. Our plans as more thought-leading institutions enter into commercial utilization of the product, that this trend will continue moving forward. That is again confirmed by commercial highlights that were seen during the course of the fourth quarter. Commercial use of the system was approved and began at two important comprehensive stroke centers, Mount Sinai and Harbor-UCLA. As customers of that size and reputation, Mount Sinai is the ninth-ranked neurosurgical center in the United States. As customers of that type move from evaluation to commercial utilization, they're replaced in our sales funnel by additional hospitals that are being trained. During the fourth quarter, evaluations began, training began at Lenox Hill Hospital in New York City, as well as one of the leading facilities in South Florida, Baptist Health, and its Marcus Neuroscience Institute. During the course of the fourth quarter, other key customers, other meaningful comprehensive stroke centers in the U.S., including Westchester Health and Albany Medical Center, completed their IRRAflow evaluations and moved into the final commercial decision-making mode. We would expect that these customers, during the first part of 2023, would also become commercial customers. As I mentioned earlier, our focus outside the U.S. shifted during the fourth quarter from adding new distribution partners to driving adoption in a similar fashion. During the quarter, our distribution partners increased their commercial activities post-COVID pandemic impact, and we saw disposable reorders from a number of distribution partners, including Latin America and Spain. Two additional German accounts purchased disposables to initiate IRRAflow evaluations there. In another exciting trend for us commercially, we sold more capital equipment in the United States than we had in any previous quarter with one of our key customers, West Virginia University, validating their adoption of the system by moving towards capital ownership and a satellite hospital from one of our other key commercial partners, Northwestern Medicine. One of their satellite hospitals, Central DuPage Hospital, also purchased capital to expand that system's utilization of the system. All of this commercial progress continues to be driven by our ability to more effectively engage our customers in person to tell the IRRAflow story. During the fourth quarter, our team participated in three extremely important in-person global neurosurgical and neurocritical care conferences in the United States at the Congress of Neurological Surgeons annual meeting. That poster that I referenced earlier, was presented on active CSF exchange and removal during subarachnoid hemorrhage to reduce shunt dependency. As a reminder, that poster showed that only two of 15 patients with subarachnoid hemorrhage were required to undergo a secondary shunt surgery. This was a statistically significant reduction compared to historical averages. At the European Association of Neurosurgical Societies annual meeting that occurred in October in Belgrade, another clinical poster was presented that showed the impact of active fluid exchange for the treatment of intraventricular hemorrhage. In both of these meetings, our key customers participated in in-booth presentations to share their clinical data and their experience with their peers. Our team also exhibited and met with customers at the Neurocritical Care Society annual meeting during October. I referenced the data here. This was more specifically the poster that was presented at the CNS annual meeting in 2022 that showed that significant reduction of shunt dependency with the IRRAflow system. Finally, I wanted to stress to those that have followed the IRRAS story, or perhaps for those that may be new to the progress that we are making, that the key investment thesis hasn't changed. We're targeting a sizable market where thousands upon thousands of patients are in critical need of improved technology because the accepted standards of care are outdated and continue to deliver subpar outcomes in clinical evidence. Our innovative product portfolio now has limited risk associated with it. Next-generation systems have been ir-approved and are now being utilized by customers. Key regulatory approvals are in place that support continued utilization. The impact of the product has now been validated both commercially and in a growing pool of clinical evidence. That is supported by direct sales team in key markets and a network of distribution partners now emboldened with a United States partnership with Medtronic that will allow us to take advantage of a razor blade business model, where a growing install base can result in repeat and increased orders of our high-margin consumables. Moving forward, our focus has shifted from bringing a product to market, and now we are laser-focused on commercial execution and expansion to be able to drive and help more patients on a daily basis. With that, I thank you for your time. I thank you for following the IRRAS story, and I'll hand it back to the moderator, and open it up for any questions that you 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 more questions at this time. I hand the conference back to the speakers for any closing comments. Thank you very much. For those that are either listening now or will listen to the recording of this year-end presentation for IRRAS, we welcome your outreach and would be open to answering questions at any future time as well. We encourage you to connect with us through our broad social media platform across all social media portals. Follow our IRRAS Radio podcast series, as well as our downloadable mobile applications, IRRAS Academy, to stay up to date on all of our latest progress. We thank you for your support. We thank you for your continued interest in IRRAS, and we look forward to staying in close contact moving forward. Have a great evening. This concludes the call. You may now disconnect.
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