Good morning, and welcome to the IRRAS Q2 2022 earnings call. All participants will be in listen-only mode. Should you need assistance, please signal for 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. Please go ahead. Thank you very much. Good morning, everybody, and welcome to the IRRAS Q2 2022 earnings report. I'm Will Martin, President and Chief Executive Officer of IRRAS, and I'm excited to continue to share our company's forward progress with you. Moving forward to slide two, we'll start just by referencing that at various points during today's discussion, I may make forward-looking statements. I want to have the appropriate disclaimers in place. Starting on slide three, you'll note, as we recently announced, the Q2 of this year was our eighth consecutive quarter of revenue growth. During the Q2, we generated SEK 9.7 million of revenue, 13% growth from the previous quarter, and 90% growth from the same period a year ago. Furthermore, in terms of financial highlights, the growth of IRRAflow placements, both in terms of commercial systems in the United States as well as total systems that have been deployed globally, continued to increase. We saw stability and slight improvement on some of the bottom-line metrics as well, including earnings per share and our cash flow of -SEK 31 million during the Q2, which has improved from both the previous quarter as well as the same period a year previously. We think about and discuss significant recent events that occurred during the quarter on slide four. The company's financial position and the steps that we are taking to address that was obviously our top priority during the course of the Q2. As we've announced to investors, we are initiating a proposed rights issue to extend the company's financial runway. This rights issue is designed to raise up to SEK 215 million, which will provide sufficient capital for us to continue to implement our growth strategy for more than 18 months. The rights issue that has been proposed is 77% covered at this point through subscription and guarantee commitments, which represents guaranteed issue proceeds of at least SEK 166 million. This topic will be voted upon by shareholders at an extraordinary general shareholders meeting to be held on the third of August, with the follow-on proposed subscription period tentatively scheduled from the ninth to the 23rd of August. In conjunction with the proposed rights issue, IRRAS also released updated financial targets as well as provided an update on our business as a whole, in order to ensure that all investors had the appropriate guidance to make their decisions prior to the rights issue subscription decisions. These updated financial targets stated that during 2022, our revenues are projected to exceed SEK 35 million, with gross margins above 30%. Revenue expected to grow in 2025 to exceed SEK 350 million, with continued improvement of gross margin growing to above 60%. We also expect by 2025 to be cash flow breakeven. In addition, to these new financial targets, we also referenced the fact that we are considering the possibility of, expanding our commercial strategy, to consider potential commercial partnerships with larger, established medical device companies. Also in order to continue to improve, our cash flow, we'll continue to look at ways to remove operating expenses from the organization and continue our trend of fiscal responsibility. On Slide five, beyond the financial update, I want to highlight additional, significant events that have occurred during the Q2. Our partnership with The Mount Sinai Hospital in New York City, New York, in the United States, generated the first patient enrollment in what is known as the DIVES clinical trial. Within the DIVES clinical trial, The Mount Sinai Hospital will prospectively enroll patients that have been treated with IRRAflow and compare these outcomes to their historical treatments with passive legacy drainage systems. This trial is being led by Dr. Christopher Kellner, one of the up-and-coming thought leaders in the world of neurocritical care and cerebrovascular treatments. The Mount Sinai Hospital is one of the top neurosurgical facilities in the world, ranked in the top 10 in the United States. This trial and our other new customers that are coming on board in the United States are now using the next-generation IRRAflow system as the launch of that product expands. During the course of the quarter, four new Comprehensive Stroke Centers in the United States began product evaluations with this new system, and additional markets outside the United States that are governed by U.S. FDA clearance received this latest system. Furthermore, our expansion of IRRAflow globally as we expand and add new distribution partners continued during the Q2. We shipped first units to Australia after the regulatory approval of the Therapeutic Goods Administration that we announced at the end of Q1. We also expanded into Asia further with distribution partners and shipments occurring to Qatar, India and Vietnam. We also established a partnership with a distribution entity in Ukraine, and we're taking this partnership very seriously as we have the opportunity for our neurocritical care products to make a difference during the challenging times that country is facing now due to the ongoing conflict. Taking those significant events and looking at the key financial data on slide six, you can see the performance from the quarter in more detail. As I referenced, revenue growth from SEK 8.6 million- SEK 9.7 million from Q1 of this year to Q2. Gross margins continue to be stable with gross margin for the Q2 at 31%. As we referenced, the Q1 margin of 49% was elevated due to some one-time adjustments. The Q2 gross margin confirms our goal and our expectation that we will stabilize with gross margins in the positive area and continue to improve moving forward. Earnings per share, cash flow continue to improve QoQ. At the end of the Q2, we had SEK 17.1 million of liquid funds as we work through the short-term loan agreements in place with Bacara Holdings, one of our key investors, that was announced during the quarter as well. That will provide us working capital to navigate the remainder of the rights issue process. Looking at the quarterly results in more detail, starting on slide seven, you can see that thus far, for the H1 of 2022, through two quarters, our revenue after the six-month period is SEK 18.3 million, which in comparison to all of 2021, revenue of SEK 22.4 million, is indicative of the growth that is continuing. We continue to see contribution from each of our market segments. Revenue from the United States has continued with the same team size in place to be comparable for each of the past several quarters. We're continuing to see increasing contribution across the board from our international distributor markets as well as our international direct markets, which we expect to continue to accelerate after the summer holiday period in Europe. Moving on to slide eight, you continue to see the trend of growth in IRRAflow capital equipment placements or shipments around the world during the course of the Q2. We went from 153 IRRAflow systems to 168 during the quarter. That number was driven upward by growth in the U.S. commercial systems as in particular, Northwestern Hospital shifted from a successful evaluation to becoming a commercial customer, as well as the growth in distribution partners that I referenced earlier. During the quarter, the number of systems supporting U.S. evaluations dropped slightly. This was due to two reasons. One was the conversion of the systems from Northwestern, from an evaluation over to commercial systems. Where during the quarter, as part of our transition from our previous generation IRRAflow system to the latest generation IRRAflow system, we brought back a number of evaluation systems, for swap out and upgrade, for evaluations that had been paused during the pandemic. As we get those hospitals back up and running and restart their training, we want to have the latest generation of IRRAflow equipment in those hospitals, and that swap out was initiated during the Q2. As those accounts come back up into the evaluation phase, they will be relaunched with the latest generation systems. On slide nine, I'd like to give a little bit more detail regarding the rights issue that was referenced earlier. As I mentioned, we have proposed a rights issue to raise up to SEK 215 million to provide working capital to fund the company's growth strategy for at least 18 months. Proceeds of at least SEK 166 million. 77% of the rights issue potential total is covered at the initiation through subscription guarantee commitments. Bacara Holdings and Lexington Holdings, two key IRRAS shareholders, have committed to subscribe to their pro rata amount, provided that those combined holdings do not exceed 30%. We have a new external guarantor, Spetses Investments Limited, which will guarantee up to SEK 100 million. For this external guarantee, they've received no additional remuneration outside of coverage of their legal costs, at the proposed subscription price of SEK 0.3. The EGM is scheduled for August the third, with the subscription period to follow, potentially after the publication of the prospectus, to run from the ninth of August to the 23rd of August. On slide 10, a little more detail on those financial targets that were referenced during the course of the Q2. Again, revenue projected to exceed SEK 35 million this calendar year with gross margins stabilized above 30%. That revenue is then projected to grow to exceed SEK 350 million by 2025, with gross margins improving to above 60%. That revenue in 2025 will also be accompanied by transition to a cash flow breakeven business at that time. In order to help drive towards those financial targets, not only are we looking to grow the top-line revenue by exploring all potential elements of commercial strategy, the possibility exists that we may expand our direct and distributor model by considering partnerships with established medical device companies to accelerate the rollout of our products. At the same time, we're looking constantly at various ways to reduce operating expenses and drive down the associated burn rates to allow the funds generated by this rights issue to fuel our company's growth for at least an 18-month period. On slide eleven, after having highlighted the quarterly results and the key events that occurred during the Q2, I'd like to circle back and remind the investment community of IRRAS, our products, and our key short-term goals. As you likely know, IRRAS is a unique bicontinental Swedish-American commercial stage company, and our primary focus is on delivering innovative products for neurocritical care, those critically ill patients that are suffering from traumatic brain injury or intracranial bleeding that are being treated in the neurointensive care unit. Legally headquartered in Stockholm. Our executive offices and many members of our team are based in Southern California in San Diego. We also have direct sales teams in the United States, in the Nordic markets, in Germany, as well as sales leadership and global warehouse and logistics in the Netherlands. As you can see, those direct markets are highlighted in darker blue on the map and our increasing network of distribution partners is highlighted in turquoise. It now gives us a growing set of geographies to sell our IRRAflow and Hummingbird product lines and take advantage of a large, attractive addressable market that's outlined on slide 12. Currently, our initial areas of focus are intracranial bleeding and traumatic brain injury, which make up a $2.4 billion market opportunity. As our IRRAflow system is used to treat more and more patients and a growing pool of clinical evidence is published by physician partners, we're seeing that a meaningful percentage of IRRAflow patients also are treated with therapeutic drugs. That now allows our company moving forward to seek the expansion of labeled indications towards targeted drug delivery. As we do that in coming years, that will allow us to target an even greater market opportunity, which can take the total addressable market in the European Union and United States alone to approximately $7 billion. On slide 13, again, as a reminder, we'll target that market opportunity with IRRAflow, our lead product, which is the world's first irrigating intracranial drainage system, and that is complemented by the Hummingbird family of intracranial pressure monitoring tools. Focusing on IRRAflow in more detail, starting on slide 14, you can see that IRRAflow is a traditional razor-blade model. There's a small piece of capital equipment, the IRRAflow control unit. To the IRRAflow control unit, two disposable components are used in the treatment of each patient. There's a dual-lumen IRRAflow catheter that you see in the middle of the slide that is placed into the patient's brain to remove collected toxic materials. On the left, that IRRAflow catheter is connected to a IRRAflow tube set and intelligent digital pump. Both of those elements are single-use disposables as they work to irrigate and drain to more effectively remove this collected material from the patient's intracranial space. On slide 15, you can see how that combination of irrigation and drainage works. While the patient's condition is being monitored, as their intracranial pressure is monitored, the system will drain off collected toxic materials. This typically is collected blood in the form of a hematoma or bacteria that may have started to colonize during an infection, and that drainage is combined with automated recurring irrigation. The irrigation does two things. As you can see in the image on your screen, with a traditional passive drain that does not use irrigation, solid particulate very quickly starts to collect and block drainage holes. You can see that with the market-leading orange external ventricular drain. With IRRAflow's irrigation, the drainage holes are kept free from blockage formation. Where the passive drain can become blocked up to 47% of the time as documented in clinical evidence, with IRRAflow, the system's been designed to virtually eliminate the possibility of these types of occlusions which impact drainage. In addition to keeping drainage ongoing, the irrigation also helps to dilute the collected blood, making it easier to remove. In the upper right-hand portion of the screen, you can see the impact of that irrigation. The image on the left showing dark viscous blood is the type of material that is drained at the beginning of a patient treatment. Over just a period of 24 hours, that material has been diluted, and you can see how the color, how the density, and how the viscosity of the drained material starts to evolve due to the impact of this irrigation. Moving on to slide 16, you can see the impact of this irrigation with some of the clinical data that has started to be published. These are the early patient outcomes from West Virginia University's Rockefeller Neuroscience Institute, looking at their first 45 IRRAflow patient treatments. During all 45 patient treatments, 0% catheter occlusion rate was seen. Almost 25% of these patients had some type of intracranial medication administered through the system, and the outcomes for these patients showed meaningful improvement across multiple metrics. When treating chronic subdural hematomas, there was 100% improvement in the shifting of the brain. In addition, both shunt dependence and vasospasm, both clinically relevant endpoints, caused by collected blood in the brain, showed reduced occurrence with IRRAflow compared to historic published levels. Shunt dependence with IRRAflow was shown to be approximately 13%, which is comparable to somewhere in the 18% range in clinical literature. Vasospasm ranged from 17%-25% with IRRAflow, which when compared to published rates in clinical literature, range from 40%-70%. With this being the first 45 patient treatments at West Virginia University, we've been very encouraged by the clinical data that was associated with the IRRAflow treatment. On slide 17, you can see a new representative case example, and this is the first patient treatment from the DIVES clinical trial, the first patient treatment at The Mount Sinai Hospital in New York City. As you can see, the initial CT scan image on the left shows significant blood accumulation within the brain's ventricular system. The ventricles are the butterfly-shaped reservoirs of cerebrospinal fluid that you typically see within the inner spaces of the brain. Within the first day of using IRRAflow, you can begin to see the breakdown of that collected blood. After the patient had stabilized, the physician decided to utilize a clot-busting medication, tPA, which was irrigated through the IRRAflow system. Within the next 24-hour period, a vast majority of the collected blood has now been broken down and removed by the IRRAflow system. Within 67 hours, within three days, use of IRRAflow has removed more than 95% of the collected blood. This patient who came in intubated and in a coma was on that third day sitting up, eating breakfast with his family in the ICU room and was released back to an independent life. This individual was 90+ years old, and with traditional therapy, the surgeons have noted that they would not have expected that type of outcome. On slide 18, you can see the before and after image. Just within less than a three-day period of using IRRAflow, a large majority, virtually all the blood was removed without occlusion, without complication. After stopping treatment with IRRAflow, the catheter was removed, and the patient was released within an 86-hour period. Moving forward to slide 19, you can begin to see the continuation of the growth that comes along with patient outcomes such as that one. As I mentioned before, the strong development in the global shipments, the global install base of IRRAflow, now up to 168 systems, provides the number of razors which will allow the use of more disposable products or razor blades to drive additional sales growth. Our trailing 12 months of revenue after the Q2 is almost SEK 32 million. On slide 20, this continues to be supported and driven in the United States by a meaningful percentage of U.S. revenue coming from commercial reorders of disposable products. For the fourth consecutive quarter, meaningful percentages, during the Q2, 76% of our U.S. revenue was generated by disposable reorders. This is supported by a growing network of key opinion leader surgeons, that are helping us to tell the story, helping to collect the clinical data, and helping to spread the sphere of influence through peer-to-peer engagement. Not only Dr. Siddiqui and Dr. Levy, who we work closely with from the University at Buffalo, and Dr. Brandmeier from West Virginia University, but as we add additional thought leading prestigious centers such as Mount Sinai, such as Northwestern, we now begin to work closely with additional thought leaders such as Dr. Kellner, such as Dr. Jahromi, and we're excited for them to get involved in our clinical projects. Obviously, I referenced earlier that Dr. Kellner has initiated the DIVES clinical trial, but Northwestern and West Virginia are both submitting the paperwork to join the ARCH clinical study that we've referenced before in conjunction with University of Helsinki. Moving forward to slide 21, I'd like to highlight the other key commercial accomplishments from the Q2 as revenue continues to be driven from a variety of sources. In the United States, 76% of the revenue was generated by disposable reorders. That comes from hospitals such as Northwestern shifting from a successful evaluation to placing a commercial stocking order. Northwestern is the number five ranked hospital in the United States for neurosurgery, and we're very excited to be working more closely with them. The remaining U.S. Revenue driven by new hospitals placing orders to start evaluations. During the quarter, four new hospitals, four new Comprehensive Stroke Centers, Boca Raton Regional Hospital, Penn State Hershey, University of California, San Diego, and Harris Health Ben Taub Hospital in Houston, Texas, all placed orders to begin evaluating IRRAflow. On top of that, as I've referenced before, our distribution network grew during the quarter with orders deeper into Asia from Vietnam, Qatar, and India. We placed our first shipment to Australia during the quarter. We added a distribution partner in Ukraine and had upgrade orders from Kuwait and Latin America, both for continued disposable usage and to upgrade to the latest generation IRRAflow control unit. Across all elements of our business, contribution occurred during the Q2. That sets us up for continued commercial growth as you can see on slide 22. Growth during the quarter was driven by continued return to normalcy post-COVID restrictions, increased customer interaction as a result of the resumption of global neurosurgical conferences on both sides of the Atlantic from the German National Congress for Neurosurgery, the DGNC, which was held in June to the American Association of Neurological Surgeons, AANS, that was held in Philadelphia back in April. As you can see, in both situations, engaging with our customers, helping to train existing customers, helping to fill the sales funnel moving forward, and having the all-important peer-to-peer interactions from experienced physicians presenting their data in our booth to physician speaker programs where the clinical data is shared. These are the types of interactions that were not possible over the past two years due to COVID pandemic restrictions. Seeing these types of activities return to normal allow us to have increased confidence that the eight consecutive quarters of growth can and will continue moving forward. As I referenced on slide 23, the clinical data that was presented at AANS and other congresses will continue. At AANS, the initial wave of data from the roll-in cases for the ARCH clinical trial was presented. Five cases all completed in approximately five days. Within 72 hours, 90% removal of blood, very similar to the case that I showed earlier from the DIVES trial. This was compared retrospectively to the averages from the CLEAR III trial, which used traditional drainage and tPA, which showed an average of 14 days in the ICU. Sizable differences between outcomes and length of stay when IRRAflow's irrigation is employed. We look forward to expanding upon this data and continuing to publish it to drive increased adoption moving forward. Finally, just like to remind our shareholders and those interested in IRRAS of the key investment thesis. We continue to target a sizable market for intracranial bleeding and traumatic brain injury, where outdated subpar treatment remains the gold standard. Our innovative product portfolio with IRRAflow and Hummingbird now has limited product development and regulatory risk. The products have been used in more than 450 cases at this point, have key regulatory clearances in place, and their impact continues to be validated both commercially and clinically. We have a direct sales team that's dedicated to our products in key markets in both United States and Europe, and we're constantly looking to add to our network of established, experienced in neurosurgery distribution partners, which will allow us to continue to execute upon this razor-blade model by increasing the capital equipment install base and driving repeat orders of single-use, high-margin consumables. Moving forward, particularly as we navigate through this rights issue process, our focus will be on expanding commercially and continuing to execute as a company more efficiently to drive revenue growth and increase shareholder returns. With that, I'd like to move forward to slide 25 and encourage those that are interested in learning more about IRRAS to follow us through our various social media channels. Download the IRRAS Academy mobile application to stay up to date on the latest and continue to watch and follow along with the recurring updates that we will provide to the market through all of these respective channels. With that, thank you very much. I'll pause there, hand it back over to the moderator, and open it up to any questions that any of you may have. Thank you. We can now begin the question and answer session. If you do wish to ask a question, you may press star then one on your telephone to register. If you are using a speaker phone, 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 and then two. At this time, we will pause momentarily to allow any questioners to register for a question. As we are showing no questions at this time, I might hand it back to Mr. Martin for some closing remarks. Thank you very much. Again, we appreciate your time and your focus and your interest in IRRAS this morning. I'm pleased to report another strong quarter of revenue growth, up to SEK 9.7 million. We're excited for the key foundational elements that we continue to put in place. We are looking forward to navigating the rest of this rights issue process. As we navigate through that process in coming weeks, we will keep the investor community updated and look forward to continuing to share our progress with you every step of the way. Again, thank you for joining us today and we will stay in very close contact. Have a great weekend.
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