Good afternoon, everyone. Welcome to the IRRAS Q1 2022 Earnings Release Report. I'm Will Martin, President and CEO of IRRAS, and I'm excited to continue to share with you our forward movement and progress that continues. On slide two, I'll start with the standard disclaimer that I may make forward-looking statements during this session, and make your own investment decisions accordingly. Starting on slide three, the financial highlights of the past quarter. Q1 2022 was our seventh consecutive quarter of revenue growth. Revenue of SEK 8.6 million, which represented more than 100% growth from the same quarter last year, and 20% sequential quarter-over-quarter growth from the fourth quarter of 2021. Our forward progress in advancing our commercial launch continues. Globally, we now have more than 150 IRRAflow systems installed at customer locations, up from just north of 130 in the previous quarter. We now have increased from 30 to 34 commercial systems in the United States. In addition to this top-line revenue growth, our company continues to make needed progress at the bottom line as well. Both earnings per share and earnings before interest and taxes showed noticeable improvements from the previous year, as well as the previous quarter, during the first quarter. Moving forward to slide four, let's dig into a little more detail on some of the significant events that occurred during the first quarter. We've talked previously about the need to support our products, particularly IRRAflow, with meaningful comparative clinical data. It was important to note that during the first quarter, the largest IRRAflow data set to date was presented by surgeons from West Virginia University Hospital that confirmed the mechanism of action, and we'll talk in more detail about this data in coming slides, but really reinforced the overall patient impact that the system can have compared to traditional drainage. In addition, during the first quarter, the next generation IRRAflow system was introduced and patient treatments began here in the United States. IRRAflow received initial regulatory clearance in Australia that will allow us to begin commercial distribution of the system this year. Moving forward to slide five, digging into the key financial data in a little more detail. There's a couple of things that I really want to highlight. First and foremost, the top-line revenue of SEK 8.6 million. We've talked extensively about our company's focus on cost containment, and that continues to come through both in the earnings numbers that I referenced earlier, but also now with a gross margin of 49%. That obviously is driven by our top-line revenue growth, but also those cost containment activities and the decision that we made during 2021 to bring assembly of the IRRAflow control unit in-house, allowing us to better control our cost. Now it's also important to note that at the end of the first quarter we had SEK 19.6 million on hand and our cash flow from the previous quarter was - SEK 33.2 million which signifies a clear need for fundraising to continue to support our operations. And I'll discuss that in more detail as we move forward throughout the presentation. On to slide six, I want to highlight again seventh consecutive quarter of revenue growth since the primary impacts of the COVID-19 pandemic. Across all of our revenue categories all geographies contributed during the course of the quarter. Continued growth in the United States, noticeable growth within Germany as commercial activity begins to normalize, and then also continued contribution from distribution partners, either throughout Europe, but more importantly in other geographies around the world. In the first quarter of 2022, SEK 8.6 million of revenue, which signifies in one quarter, more revenue than we did during the entire year of 2020. On slide seven, you can continue to see why revenue continues to move forward. Another meaningful quarter of growth in our capital equipment footprint. Now up to 153 IRRAflow systems deployed globally. We continue to have a number of those systems that support U.S. evaluations, but more importantly, the number of commercial systems where customers have adopted the system and begin to use it regularly for recurring patient treatments has again grown. As I mentioned, commercial activity, particularly in Europe, really began to normalize during the first quarter. The number of systems, both with direct customers within Europe as well as our global distribution partners, both showed noticeable increases during the first quarter. On slide eight, I want to circle back to my comments about the need for funding of the organization. As we mentioned in the report, we have engaged financial advisors that are currently working to execute upon a long-term financing plan. There's not a whole lot that I can say at this point other than that process is underway. I want to be as transparent as I possibly can to current shareholders as well as potential investors that we want to provide sufficient working capital for at least an 18-month period. Over the last several years, the ability to grow and scale the organization and the ability to accelerate the commercial launch has been impacted by the company's funding position, and the board is committed to providing the company working capital to capitalize and build upon this growth for at least another 18-month period. The support of our leading investors in place, and in coming weeks, as the details of the financing syndicate are completed, will be announced, and we'll discuss this in significantly more detail. On slide nine, moving forward, I think it's another important thing to note that, historically, with IRRAS having manufacturing outsourced, all operations expenses were included in COGS, including some of those that were not directly related to production. Last year, as we began in-house assembly of the IRRAflow Control Unit, we worked with our auditing partners, and we've now reallocated certain expenses from direct manufacturing costs to overhead administrative expenses. As a result, our COGS calculation, our cost of goods sold, now only includes direct production-related expenses. This classification change has brought down the COGS number. It's resulted in the improved gross margins that are shown in this report. But at the same time, you also see the corresponding increase in administrative expenses. As a result, not only has gross margin improved, but also we've seen improved earnings compared to the same period last year, driven not only by this classification change, but also our ongoing focus on cost containment. For the quarter, we reported a 49% gross margin, but it's important for investors to note that this percentage, this gross profit, was positively impacted by a one-time adjustment for favorable inventory of SEK 1.5 million. If you exclude this adjustment, the stabilized gross margin for the quarter would have been approximately 32%. Still a noticeable, meaningful improvement versus our gross profits historically as the organization. Our plan and our expectation is that our gross margins will be stabilized in these positive levels moving forward as we continue to make progress. Now, after finalizing that summary of the previous quarter, let's move on to slide 10. We'll give a little bit of a more detailed overview of the organization. As many of you are aware, IRRAS is a unique bicontinental Swedish-American commercial-stage company. We are focused on innovation in neurocritical care, the sickest patients in the neurosurgical intensive care unit, typically suffering from intracranial bleeding or traumatic brain injury. Publicly traded on Nasdaq Stockholm, legal headquarters based there in Stockholm, with a footprint not only in the United States and Southern California, but with direct sales presence in the U.S., in Germany, and throughout the Nordic markets, as well as a growing network of distribution partners to introduce our products into markets around the world to support these critically ill patients in need. Moving forward to slide 11. As we focus on that neurocritical care market, you can see that it's a sizable, meaningful, attractive market opportunity. Intracranial bleeding and traumatic brain injury alone account for a market opportunity north of $2 billion. Our company expands its focus and starts to think about how we can take advantage of targeted intracranial drug delivery, the market opportunity grows exponentially. These are patients that are critically ill without attractive treatment options to provide hope for the patients or their families. With our IRRAflow and Hummingbird product portfolio product lines, as you can see on slide 12, we are focused on bringing next-generation solutions to neurosurgeons to provide treatment opportunity and hope for these critically ill patients. IRRAflow is our lead product. It's the world's first irrigating intracranial drainage system. Hummingbird is our complementary product line that is focused on the diagnostic side of assessing the extent of brain injury by measuring intracranial pressure. As we move forward to slide 13, I want to talk about IRRAflow in a little more detail. We've referenced in the past that IRRAflow is a razor blade system. There are three components to the IRRAflow system, as you can see on slide 13. On the right is a representative picture of our next generation IRRAflow Control Unit. This is where the neurosurgeon and the nursing team input desired treatment parameters and monitor the patient's condition throughout the course of therapy. The IRRAflow Control Unit is connected to the IRRAflow tube set, the digital pump that controls both irrigation as well as drainage of excess fluid out of the patient's body. That's connected to a dual lumen catheter, the IRRAflow catheter you see there in the middle that is inserted into the intracranial space. The tube set and the dual lumen catheter are disposable components, single use, and they are then connected to the capital equipment, which is reusable across a number of years. The capital equipment serves as the razor blade and a majority of our revenue is driven by the disposable single use razor blades. On slide 14, we'll look at the mechanism of action of IRRAflow in a little more detail. The mechanism of action is referred to as active fluid exchange. Through a combination of irrigation and controlled drainage, collected toxic material within the brain is diluted and more easily removed to therapeutically impact the patient. The entire time the patient's condition or ICP is monitored and treatment is adjusted accordingly. The impact of active fluid exchange, this combination of irrigation and drainage, can actually be seen on the right side of the screen. These images are 24 hours of difference in a single patient. The image on the left, you can see that the blood that is being drained from a patient is thick, it's coagulated, it is extremely viscous and difficult to remove. Within a 24-hour period of time, due to the irrigation that is provided by the IRRAflow system, one can easily see the difference in the consistency and the viscosity and the overall thickness of the drained material. As the material is diluted in this fashion, it's able to be more easily removed and it's less likely to clot or occlude the drainage catheter, which can happen almost 50% of the time with a traditional passive drain that does not use irrigation as IRRAflow does. On slide 15, I referenced it earlier, but it was an exciting quarter for our team. Our next generation IRRAflow system with a new drainage collection mount that allows more treatment versatility as well as a new interactive software was introduced in the United States. First patients were treated by Dr. Nicholas Brandmeir at West Virginia University Hospital. The system's now been introduced at a number of other U.S. facilities and this will be our foundational technology moving forward that will support all of our growth in the United States. As we finalize the upgraded CE mark on the new system under the new European medical device regulations, this will also be the foundation of our global growth as well. West Virginia University Hospital not only was the first to use the new IRRAflow system, but at the same time, as I referenced earlier, they also during the first quarter presented the largest IRRAflow data set to date. Looking at their initial 45 IRRAflow patient treatments during the learning curve, their outcomes still reinforced the impact and the efficacy of the IRRAflow system. Across all 45 patient treatments, there were zero catheter occlusions seen. At no point during treatment across all 45 patients did needed drainage become impacted because of a blockage of the drainage catheter. This reinforces that the IRRAflow mechanism of action using irrigation to keep drainage holes free from blockage formation works as intended. Additionally, compared to historic published data for passive ventricular drainage, traditional EVDs, all other data points that were captured during these 45 IRRAflow patients showed improvement. Catheter occlusion, as I said, was 0%. That's compared to historic numbers of approximately 19% permanent occlusion and north of 40% temporary blockages that can be seen with traditional drainage. Shunt dependence and vasospasm, both secondary indicators about the extent and thoroughness of blood drainage, both were improved. You know, 13% shunt dependence with IRRAflow compared to 18% in the published CLEAR III trial and significant reductions in observed vasospasm where vessels within the brain become constricted due to an inflammatory response. Another key thing to note that during the treatment, approximately 25% of the patients that were treated with IRRAflow had some type of targeted drug delivery performed into the brain. 20% had thrombolytic medication administered and almost 5% had antibiotic medication administered, taking drugs directly to the site where they're needed for treatment when they traditionally have problems reaching therapeutic levels in the brain due to the blood-brain barrier. We're very excited about this data that was presented by West Virginia University Hospital. They continue to track their outcomes and this data has been extremely impactful for us as we have conversations with a growing group of customers around the world. Moving forward to slide 17, I'll dig into the commercial progress in a little more detail. I referenced earlier that the installed base continues to grow, now north of 150 systems deployed at customer locations, either in hospitals or with distribution partners around the world. That corresponds in a similar fashion to driving revenue growth. Our trailing 12-month revenue now is just under SEK 27 million after SEK 8.6 million of revenue for the first quarter of 2022. On slide 18, it's important to note that a consistent level of revenue continues to be driven by disposable reorders from commercial customers. We've talked about our growing network of key opinion leader surgeon partners and usage from our existing customers during the first quarter again drove more than 70% of our revenue in the United States. That number has stabilized. It's plateaued at this point in the 70%-80% range, which is exactly what we want. A significant percentage, approximately 75% of our business coming from reorders and the other 25% from continued customer growth as we bring in more new customers, more evaluations to increase this foundation of commercial contribution. You can see that on slide 19. Not only do we again have a record number of patient treatments with IRRAflow during the first quarter, 74% of our U.S. revenue was driven by reorders, as I just referenced. There were another five IRRAflow evaluations that started during the first quarter. Northwestern Memorial Hospital in Chicago, Illinois in the U.S., one of the top 10 global leaders in neurosurgery, is now evaluating the IRRAflow system. University of Maryland Medical Center, another top 50 center in the U.S., University of Leipzig in Germany. There will always be a delicate balance where we want most of our revenue to be driven by reorders. We also want to continue to expand our overall customer base with new customers and new evaluations ongoing. We referenced in the report the fact that COVID-19 restrictions began to be reduced, particularly throughout Europe. This allowed our team to support our partner, our network of distribution partners in a way that we've not been able to over the last two years. Training in person, supporting patient treatments, helping to drive commercial interest in initial patient treatments in markets throughout Europe and around the world. This resulted in a number of reorders, disposable reorders, additional capital equipment orders from our distribution partners in a number of markets such as Italy across Europe, but also meaningful contribution from other partners in the Middle East as well as Latin America. We established a new distribution partnership, as you can see on slide 19, excuse me, on slide 20, with a new distribution partner in Saudi Arabia. We were able to support a distributor training with our Latin American team that resulted in the first patient treatment in Panama. As you can see on slide 20, initial experience with a distribution partner in Mexico resulted in approximately 25 patient treatments since the beginning of the year in Mexico, which we've been able to support from our team here in the United States. Across the entire footprint of IRRAflow activity, the first quarter was a quarter where we saw unprecedented commercial activity. COVID restrictions were reduced. Our movement was freer than it's been. The impact of our distribution partners and our direct team surpassed anything that we've seen within the past several quarters. That was reflected in our overall results. Moving forward to slide 21, the other piece that I wanted to highlight is the continued investment in clinical data by the company. As we referenced earlier, the overall activity will continue at the AANS meeting, the American Association of Neurological Surgeons, which will begin this weekend in Philadelphia. Our experienced users from West Virginia University as well as Helsinki University will be sharing their experience while in Philadelphia. Other new customers, including Dr. Brian Jankowitz from University of Pennsylvania, who is excited about the system and is helping to drive through the approval process at their comprehensive stroke center, will help speak on our behalf. We're excited again to have an in-person conference and in-person event to build upon a lot of the other exciting activity that is ongoing with the IRRAflow launch. Moving forward to the next slide, I think it's also important to appreciate all of the various pieces that are currently in place. Moving forward to the next slide, please. One can see that the investment, as I said, in clinical data continues. At AANS, there will be a number of IRRAflow posters that will be presented. This is one from Helsinki University Hospital that continues their patient series on IRRAflow for the treatment of intraventricular hemorrhage, highlighting the impact of the system's irrigation and ability to deliver therapeutic thrombolytic medication. All cases that will be presented were completed in approximately five days, compared to an average of 14 days during the CLEAR III trial. All cases demonstrated removal of 90% of blood within 72 hours. We're excited for Dr. Behnam Rezai Jahromi from Helsinki University Hospital to be able to present this data. This is data that feeds into the overall ARCH clinical study, as you can see on the next slide. We've talked at length about what is being accomplished in the ARCH study. It's important to note that enrollment progressed meaningfully during the first quarter. The ARCH study has now enrolled 12 patients, and that study will have interim checkpoints that are released at 50% enrollment, which we expect later this year. That investment in clinical data, the normalization of commercial activity, has really reinforced the key investment thesis of IRRAS during the first quarter. We're targeting a sizable market with an innovative product portfolio that's been validated commercially and clinically. Our team, both direct sales in Europe and the U.S. as well as our distribution partners, they're as active as they've ever been, implementing our razor-blade business model. Moving forward, our focus is on commercial execution, and the only way that we can do that is by clearing the financial overhang that has plagued the company over the last several years. Our board, our leading investor, are committed to completing a needed fundraising in the very near future that will provide us sufficient working capital to drive the business forward for at least another 18 months. We're committed to obviously sharing the details regarding that imminent financing in the very near future as pieces are finalized. That will then help us to continue to drive similar results moving forward. With that, I'll stop, and we'll open it up to any questions that participants may have. Thank you. If you wish to ask a question, please dial zero one on your telephone keypads now to enter the queue. Once your name has been announced, you can ask your question. If you find it's answered before it's your turn to speak, you can dial zero two to cancel. Currently, we have one question in the queue. That's from the line of Oscar Bergman of Redeye. Please go ahead. Your line is open. Hi, guys. I have a question or a few set of questions actually, but I'll do them one by one. The first one relates to the reallocation of certain costs in COGS to administrative expenses. I'm just wondering if you could elaborate on what this number could be for the coming quarters. Is it in line with the SEK 3.5 million this quarter? Thanks, Oscar. It's great to hear from you. Our expectation is that this reclassification of certain expenses from direct production costs to administrative overhead will continue moving forward. This quarter from our perspective is a more representative example of what it costs IRRAS to manufacture the system. Aside from the one-time inventory adjustment that gave a further positive impact, we would expect our gross margins moving forward to be in a similar range to what that normalized gross margin was this quarter of approximately 32%. Moving forward, I would expect that would be a similar projection for us for the remainder of the year. We haven't announced financial targets for the course of the year. We have a growing revenue base, and we have a keen focus on cost containment and stabilization. We're seeing that since we're manufacturing our own capital equipment with IRRAflow. We've seen some small stabilization and progress in supply chain, which will help that. I think we're looking at levels that will be a consistent marker for IRRAS moving forward. All right. Thank you. On the administrative expenses, I'm wondering if Q1 should be seen as a baseline for the coming quarters. Do you expect it to be higher or lower than the SEK 17 million recorded? That's a good question. There were some competing priorities during the first quarter. Our commercial activity, our ability of our team to travel and interact with customers was more than it's been in previous quarters. We've continued to look to stabilize operating expenses, wherever we can across the rest of the organization. I think that because of those moving pieces, Q1 would be a representative benchmark for the company moving forward. I think that's a good way of looking at it, Oscar. All right. I'm wondering how many feet on the ground you have in your sales force currently, perhaps especially in the U.S., and if you can give some sort of guidance as to what you expect it could be in one year from now? The size of our team is consistent with what we've communicated in previous quarters. We have not over the last three months invested or grown that team appreciably. There's been some movement within the team of adjusting a nurse educator into a sales role as part of promotion and so forth. Our team in the U.S. is still approximately six territory managers and five or six nurse educators, very similar to what we've had in the past. I'll hold off on giving you a projection of what the team may look like this time next year, because that's gonna be 100% dependent upon the outcome of our ongoing financing efforts. The financing efforts are designed to fund our ability to expand and execute upon the commercial plan. As that gets finalized and communicated, then we'll be able to give a more representative outlook for how that'll be invested appropriately to grow the team. All right. Thank you, Will. I have a final question before I head back into the queue, and it relates to the sales. I think in previous quarters, most of the sales come from reorders. I'm wondering if you could say anything about the numbers of hospitals that contribute to these reorders. If it's mainly one or two hospitals that contribute to sales, or how does the revenue split, so to say, look like? That's a great question. I'll make a note for us to provide even more of that detail in coming quarters. You know, we talk about a number of hospitals that we have very strong partnerships with in West Virginia and Buffalo. One of the things we've been most encouraged about is the next wave of hospitals after that, Vidant Health in North Carolina, the University of New Mexico, University of California, Irvine. There's a number of hospitals that are contributing to that reorder rate across, you know, the entire IRRAflow, and, you know, cranial access kits and other product portfolio. If I had to look at our group of commercial customers, I would say that approximately 75% are contributing on a quarterly basis, just depending upon their normal order sizes at this point. Good. Okay. Well, okay. Thank you very much, Will. I'll get back into the queue. Thank you, Oscar. I appreciate the question. Thank you. Once again, if there are further questions, please dial zero one on your telephone keypads now. Once again, any further questions, please dial zero one on your telephone keypads now. Okay. We currently have no further people in the queue at this time, Will. Okay. With that, I would like to thank everyone for joining our IRRAS Q1 2022 earnings call presentation. As I mentioned before, you know, the next three months are extremely important for the company, not only in terms of continuing our commercial progress, but also being able to communicate our long-term financial plans to the market. As those plans come into clarity in coming weeks, we will communicate that accordingly and look forward to not only answering any questions you might have, but also continuing to share the positive news of our growth and expansion. Thank you again for your time. I thank you for your support of IRRAS, and look forward to speaking to everyone again soon.
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