Welcome to the IRRAS Q2 Presentation 2023. 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. President and CEO, Will Martin. Please go ahead. Thank you very much, moderator. Good morning, everyone, welcome to the IRRAS second quarter, 2023 quarterly report presentation. I'm Will Martin, President and CEO of IRRAS. Over the next handful of minutes, I'll be walking you through an important period for our company, starting with the second quarter results. As always, we'll start with the standard publicly traded company disclaimer. Throughout the course of tonight's presentation, I may be making forward-looking statements. Please acknowledge those accordingly. For the second quarter of 2023, revenue for IRRAS was SEK 10.3 million, slightly down from the preceding quarter, but still showing modest sales growth from the previous quarter, excuse me, from the same period in 2022. The key metrics that we look at for our quarterly revenue, percentage of revenue from the United States, as well as total amount of revenue coming from reordering customers, continued to be strong and continued to show positive growth from historic averages. During the second quarter, the number of commercial systems deployed with customers in the United States continued to increase, as did the total number of IRRAflow systems shipped to customers globally. During the quarter, we saw market improvement in terms of the overall cash burn, with our cash flow from operating activities improving from minus SEK 50.7 million in the first quarter of this year to just under SEK 30 million during the second quarter. Taking a deeper look into the overall key financial data from the second quarter, you can see that while the revenue was down, excuse me, modestly from the first quarter, our gross margins also took a small step back as we continued to clean up the balance sheet and account for aging receivables from many of our global distribution partners. As well as an increase in overall inventory as we prepare for expansion of our commercial partnership with Medtronic in the United States, as well as an upcoming facility move that will impact our ability, excuse me, impact our ability to manufacture capital equipment over the next handful of quarters. Even with this added investment, our EBIT, as well as our earnings per share, showed improvement from the first quarter to the second. As previously mentioned, there was noticeable improvement in our cash flow quarter-over-quarter. One of the critical challenges for IRRAS at this time is our current cash position. You can see at the end of the second quarter, our liquid funds on hand were SEK 13.1 million. That has been funded by a short-term loan agreement with Bacara Holdings, our second leading shareholder. We'll continue to discuss that loan agreement here over the next handful of slides. During the second quarter, there were a number of significant events that I would like to discuss in more detail. Obviously, this is a very active time for the company, with multiple different activities ongoing, and many of these came to culmination for announcement during the second quarter. First of all, during the quarter, we announced a meaningful shift in the company's commercial strategy to prioritize the United States market. As we've discussed extensively in the past, European revenue growth has been slower than expected due to the extended impact of the COVID-19 pandemic, and also the delay in having our latest generation products available to customers as the European Union shifts to the new MDR regulations. As a result, due to the increased maturity of our product launch in the United States, where we've seen faster commercial adoption, more attractive price points, and the Medtronic partnership, we've made the decision to prioritize activities in the US market, where it can most greatly impact the future success of the company. That will allow us to better control our operating expenses, better clarify our future path towards profitability. We have started the process to close our wholly owned commercial European subsidiaries and our direct sales and education team has been adjusted, and we will rely even more heavily on our network of distribution partners to drive revenue in our markets outside the United States moving forward. You can see the key trends over the last four to six quarters here on the slide that have resulted in this shift of strategy. In addition, during the quarter, a public offer of SEK 0.18 in cash per share was made by a group of investors, including Spetses Investments, Bacara Holdings, Lexington Holding Assets, Kleanthis Xanthopoulos, Panormos Holding, Philippe Audy, and Nicolas Muroff, along with a new group of investors, potential investors, Legacy Capital, through a conglomerate known as IR Holding Bidco. This public offer was extended on the June 30th. The IRRAS board of directors, in order to assess the offer that was received, established an independent bid committee. Independent bid committee of independent directors appointed Carnegie as a financial advisor and Setterwalls as legal advisor in connection with the offer, and also engaged Grant Thornton to provide the needed fairness opinion regarding the offer. After the completion of the second quarter, after receiving Grant Thornton's fairness opinion and assessing itself, IRRAS's current strategic and financial position, as well as other available opportunities to secure needed financing for the company to continue operations, the independent bid committee has recommended that the shareholders of IRRAS accept that public offer. Grant Thornton, in its fairness opinion, assessed the forward-looking income projections of the company, analyzed historic share price, other publicly available information, as well as information from myself and other members of the company's management. That fairness opinion deemed the offer as being fair to IRRAS shareholders. The offer that was made reflects a premium of 30% compared to the 30-day weighted average share price of IRRAS up to the J une 29th. The acceptance period for shareholders expires on the August 11th, one week from today. Other significant events that have happened after the end of the quarter. Earlier this morning, we announced that we have signed an extension of the short-term financing agreement with Bacara Holdings, led by Marios Fotiadis, the company's chairman of the board of directors. If you remember previously, the company had entered into this short-term loan agreement with Bacara Holdings for a total of SEK 40 million. That has now been increased to a total of SEK 60 million, and the added amount shall be paid immediately in one additional tranche of SEK 20 million. The term of this loan will expire on the September 15th. In addition to the established interest rate for the loan at 6%, the repayment of the loan is now also secured by a pledge of the company's patents, as well as a pledge of the company's United States- the shares of the company's United States subsidiary, IRRAS Incorporated. Furthermore, it's deemed that the, that IRRAS AB will enter into a license agreement for the intellectual property with IRRAS USA Inc., and subsequently, that license agreement, as part of this loan, will be collaterally assigned to the lender. Under this license agreement, IRRAS AB will grant IRRAS USA Inc., the U.S. subsidiary, an exclusive, royalty-free, perpetual, irrevocable license to the intellectual property for use in markets everywhere in the world, except for the Nordic markets of Sweden, Denmark, Finland, and Norway. With the company's current cash position, it is a critical situation for the company to finalize the ongoing financing and secure long-term financing for the company in order to be able to pay back this loan on the expiration date of September 15th. Then finally, after the quarter, earlier this morning, the company also announced that as a result of the commercial strategy shift to prioritize the United States market, we've decided, along with our board of directors, that additional time is required to fully assess the impact of these changes, as well as the associated impact on the timeline of our previous financial targets. As such, we've informed the market today that the previously communicated financial targets remain. At the current time, we are choosing to refrain from specifically publishing a timeline for their achievements until we can finish the further assessments of the impact of our strategy shift. IRRAS's current financial outlook now states that revenue is expected to exceed SEK 350 million per year long term. Also, that the gross margin is expected over the long term to exceed 60%. Obviously, lots of activity ongoing at IRRAS, during the course of today's Q2 report presentation, I also wanted to continue to stress that our team has been focused, even with all of this activity, focused on continuing to become a leader in neurocritical care with the launch of our IRRAflow and Hummingbird product families. The overall neurocritical care market continues to be extremely attractive, $2.5 billion in the U.S. and Europe alone. That number grows significantly when considering the opportunity for targeted drug delivery into the intracranial space. With each passing day, we are showing more and more of the impact that IRRAflow can make by exchanging the cerebrospinal fluid out of a patient's brain, removing toxic material, using its combination of irrigation and drainage, and ultimately providing superior outcomes and reduced complications for patients that are critically ill in the neurosurgical intensive care unit. During the course of the second quarter, as we've been working to launch, train, and target an increasing number of hospitals, particularly in the United States, our team has launched a new set of product animations highlighting the clinical mechanism of action. During this presentation, we're sharing the slides as a PDF format, but I strongly encourage any interested parties to visit irraflow.com or our corporate website, irras.com, to see these product animations firsthand. They, they really do a good job of highlighting the mechanism of action that we see with IRRAflow. Looking in greater detail at the revenue breakdown during the course of the second quarter, you can see that our revenue was down slightly from the first quarter to the second quarter, although still showing 6% revenue growth from the same period last year. A majority of our revenue was driven once again by United States hospitals. During the second quarter, I think it's important for investors to appreciate that the number of territory managers for the IRRAS direct team in the United States decreased, both due to performance management and resignations that occurred. We, as an organization, chose not to backfill those positions during the second quarter as a result of the ongoing financing process. That did impact our ability to engage a larger number of new hospitals during the quarter. We fully expect to see the United States market continue to drive a majority of our revenue moving forward. As we've shown in previous quarters, the number of IRRAflow systems continues to increase. This number was driven primarily by the start of a number of new evaluations during within the United States market, particularly in conjunction with our partners at Medtronic. During the quarter, Medtronic accounts within Medtronic territories accounted for approximately one quarter of our total revenue. We are now working closely with Medtronic to expand the partnership from its early stages of fewer than 10 territories to now more than double in size to have more than 20 Medtronic territories participating in the commercial partnership. During the second quarter, we've continued to roll out in conjunction with our physician partners, increasing number of manuscripts that highlight the effectiveness and the safety, and now the economic impact of treatment with IRRAflow. As we've referenced before, we now have clinical data published in peer review manuscript for all treatment, intracranial treatment pathologies with IRRAflow. During the second quarter, two additional manuscripts were published. Dr. Andrew Carlson, neurosurgeon from the University of New Mexico, published for the first time a case series that showed IRRAflow and the Hummingbird product families being used in conjunction with each other. Dr. Carlson... ... used the multi-lumen Hummingbird Quad cranial access bolt to gain access into the intracranial space, to be able to perform needed drainage of cerebrospinal fluid and collected blood, irrigation and automated drug delivery with IRRAflow, and multimodal monitoring with the Hummingbird bolt, which allowed him to also assess the patient's brain temperature, brain oxygenation, and electrical EEG waves, all through one single access site. This manuscript highlighted the successful treatment of nine patients suffering from a subarachnoid hemorrhage, where treatment with the product combination resulted in blood being cleared from the third and fourth ventricles in an average of only three days. Additionally, during the second quarter, Dr. Alexandra Paul from Albany Medical College, published in the peer-reviewed journal, World Neurosurgery, her experience and Albany Medical College's experience with IRRAflow during the product evaluation. During this evaluation, Dr. Paul and the team in Albany treated three patients suffering from intraventricular hemorrhage, where an aneurysm ruptured as a result of elevated blood pressure. As you can see, when comparing the IRRAflow outcomes to their historic treatment data with external ventricular drains, you saw an average reduced treatment time of three and a half days and an average reduced length of stay in the ICU by more than six days. 24% of EVDs required replacement, compared to 0% with IRRAflow, and that ultimately resulted in more than an $18,000 per patient savings with the treatment of IRRAflow. This is early-stage data that is obviously exciting for the IRRAS team. This is the first clinical data that clearly documents this type of economic cost savings and reduced length of stay with IRRAflow, and we're now working with not only Dr. Paul. A number of other sites to publish similar data to build upon this economic data set. Outcomes such as those seen by Dr. Carlson and Dr. Paul continue to result in approximately 80%. Approximately 80% of our revenue from the United States continues to be driven by reorders of single-use disposable product. The pool of key opinion leading thought leaders, key opinion leading surgeons, and others that are working very closely with our company continues to grow. We've referenced the partnership that we have with the surgeons in Buffalo, as well as West Virginia, Mount Sinai, and Northwestern. We are very excited to report that this past week, during the Society of NeuroInterventional Surgery annual meeting that's been held in San Diego, we had the opportunity to have our second physician advisory board meeting, what we are calling a key thought leader summit and innovation roundtable. During this meeting, we had the opportunity to have 12 leading neurosurgeons, including this year's president of the SNIS Society, as well as many of the physicians that have generated the clinical data thus far with IRRAflow, along with others that are adopting the system for the first time or are still early in their experience. The ability to bring these types of physicians together with our IRRAS team will play a key role in shaping our long-term strategy and being able to continue to move IRRAflow towards becoming standard of care. In conjunction with the SNIS meeting this past week, our IRRAS team exhibited, continued to engage with key customers to expand our sales funnel, also five separate clinical posters were presented during the meeting. These will now move towards being published in an expanded format in peer-reviewed journals, there are two that I would like to highlight. The first was a proof of concept in an animal model that was presented on the main stage in an oral abstract presentation by Dr. Behnam Rezai Jahromi from Helsinki University. This proof of concept analysis showed that using IRRAflow in conjunction with cooled saline could successfully accomplish selective brain cooling, where the temperature of the brain is reduced to stop inflammation, reduce swelling, and ultimately be able to control elevated intracranial pressure that was resistant to other treatment modalities. Additionally, the team from West Virginia University, in conjunction with other sites, presented a 41 patient case series looking at the impact, looking at the impact of IRRAflow's irrigation and drainage combination to reduce the amount of collected blood and secondary shunt dependency. That case series will also now move towards publication in a peer-reviewed journal. We'll now build upon the posters that were presented this past week, as we move towards the Congress of Neurological Surgeons Meeting later in the third quarter, where we have seven IRRAflow posters that have been approved for presentation during that annual meeting. During the second quarter, obviously, there's a lot of very important events that have occurred in conjunction with the company's financing and long-term financial planning. We, as an organization, anxiously await the outcome of the bid acceptance period. In addition, we are continuing to remain focused on building a business that is primed to be successful long term. The key investment thesis of IRRAS remains unchanged. We're targeting a sizable market with a group of patients that desperately need improved treatment possibilities. Our product portfolio has been proven and continues to show an impact for these patients. That impact's been validated commercially and clinically, and we are working with our partners to execute commercially and expand our presence, both with capital equipment, but even more importantly, repeat orders of the high-margin consumables. With that, I thank you for your attention. I thank you for your patience, and I'll open it up to any questions that participants may want to ask. 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. There are no more questions at this time, so I hand the conference back to the speakers for any closing comments. Thank you very much for participating in today's IRRAS Q2 2023 quarterly report presentation. I recommend that you connect with us and continue to follow all of the important updates and progress of the organization through our social media channels. If there are any questions outstanding for shareholders regarding the active bid process and the bid acceptance period, I would recommend that you follow closely the press releases that have been issued regarding that topic and focus on the websites and Q&A that have been provided to shareholders to make sure you have the latest information. Thank you very much for your time, and I hope that you all have a great rest of your day. Take care.
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