Speaker 2
Thank you, Michael. Good afternoon everyone and here is a summary of our 2024 financial results. As of December 31st, 2024, Daxor's net assets were $36,789,893 or $7.25 per share as compared to $34,010,384 or $7.08 per share at December 31st, 2023. The increase in the net asset value is primarily due to the continued appreciation and value of the operating division. For the year ended December 31st, 2024, Daxor had net dividend income of $104,115 and net realized gains on investment security activity of $1,359,163. There was a net decrease in the unrealized appreciation on investments of $1,148,350 as we sold positions during 2024 that had prior periods' significant unrealized gains unwound into the gains realized in 2024. Included in the net increase in net assets resulting from operations of $553,926 is a non-cash stock-based compensation expense of $1,245,583. In an effort to provide incentives to employees, officers, agents, and consultants, the company utilizes equity awards through either stock options or stock awards. There was a net investment in the operating division of $1,614,124 to continue its research and development, sales and overhead for our projected 2025 product launch and ramping the commercial sales team, as well as production facilities for our next generation of blood volume analyzers and bringing in-house the production of our Volumex product which is projected to be completed by the end of 2025. That concludes my summary of the financial results. Now, I’d like to turn the call over to Dr. John Jefferies, our Chief Medical Officer, who will provide clinical updates. John?
Speaker 3
Thank you, Bob. Good afternoon, everyone. It’s my pleasure to provide an update regarding our clinical efforts at Daxor. As you may have heard, I joined Daxor as a Chief Medical Officer a few months ago. And although I recognize some of the potential for the company, I’ve been pleasantly surprised to confidently know that the potential is much greater than I appreciated. We have penetrated less than 1% of the potential listing market. We continue to identify additional opportunities that only expand the market capitalization possibilities. We’ve experienced significant growth in multiple clinical areas including standard of care utilization, evidence generation, and quality improvement efforts. We continue to expand in the new systems across the United States. We’ve added multiple academic institutions as partners, but perhaps more importantly, we have expanded significantly into community hospital systems. Historically, many of our partnerships have been with heart failure cardiologists. However, this only represents a very small fraction of the provider relationship opportunities that can be developed regarding the use of our technology. As such, we have developed strong functional relationships with other providers including general cardiologists, interventional cardiologists, structural cardiologists, nephrologists, hospitalists, intensivists, hematologists, endocrinologists, and primary care providers. These relationships have resulted in the broader use of BVA across multiple disciplines both in the inpatient and the outpatient setting. This has resulted in even greater opportunities for abstract generation and manuscript publication. Perhaps more importantly, this broader use provides us with the real-world data, which is what at the end of the day matters most to practitioners. The favorable impact of BVA has been realized across all these disciplines, further underscoring the agnostic yet potentially transformative effect that BVA can have on patient care. The generation of real-world data and additional peer-reviewed publications is a key component just facilitating practice change for both inpatient and outpatient care. Collectively, these experiences have resulted in quicker initiation and broader adoption in different institutions. The use of BVA in different subspecialties also allows providers to initiate other impactful components of the test. BVA is often leveraged for volume assessment. Obviously, the opportunity to realize euvolemia in clinical settings is invaluable for patient management regardless of their underlying diagnosis. However, with broader use, clinicians are now recognizing undiscovered red blood cell arrangements. In addition, the opportunity to phenotype leaky capillaries is unique to BVA testing and this information can dramatically change the course of critically ill patients. Now that clinicians understand that this information is available in one report, the full impact of BVA on clinical care is becoming more commonplace and widespread. We have also expanded our messaging and partnerships to other components of the care team, such as nurse practitioners and physician assistants. This represents yet another group of partnerships that we are actively pursuing and successfully developing. In short, 2024 was a highly productive year for us. I have every confidence that 2025 will hold even greater promise and better results for Daxor both financially and clinically. I'll now turn it back over to Michael for further discussion.
Thank you very much, John. Very impactful statements and obviously, very, very nuanced and important in the breadth that you have for being able to transmit the considerable clinical value of our technology. Speaking more broadly about Daxor and where we're at, as we forge ahead into what we consider really a pivotal year. Daxor remains laser-focused on our mission. We are unwavering in our pursuit of our strategic goals. We’re fueled by a relentless determination not only for transformative growth of the company, but also for widespread adoption of our technology. As you just heard from John, 2024 was a remarkable year for the company, solidifying our position as the global leader in blood volume technology every year during 2024. I'm pleased to report that there's been substantial progress for the company in revenue growth, new customer acquisitions, increasing utilization of our products by existing customers, strategic agreements to acquire a key supplier, next-generation systems under Food and Drug Administration review, positive clinical trial results, patents pending and granted, successful NIH grant awards, DoD contracts awarded, and further R&D for groundbreaking products set to launch in subsequent fiscal years. So we have a very rich and robust pipeline. I'll go into more detail in these areas. But first, I want to review for those who are new to the story of the company, what our company's mission and vision is to commercialize these products so that we can enable optimal patient care around blood volume management, which is so vital for all. Our mission quite simply is optimal blood volume for all patients. Daxor is focused on profoundly improving outcomes for the tens of millions of patients as well as the hospital systems and the payers which support that system by solving a central problem of medicine. How to provide highly accurate, convenient, and rapid knowledge of a patient's blood volume. This is a key problem in medicine, both on the inpatient and outpatient side. Managing blood volume is the cornerstone of care for some of the largest areas of medicine. We're talking about heart failure, sepsis, post-surgical blood loss, and syncope to cite a few. This urgent medical need has long been hampered by the use of proxy or surrogate markers, not direct measurement of blood volume. Many of these markers are costly. Some are invasive. None are accurate in contrast to Daxor’s proven 98% accurate system. Care teams fundamentally cannot effectively treat what they don't accurately diagnose. So our accurate rapid system is a game changer. Every metric that matters is impacted from the first principle of an accurate diagnosis. Patients receive optimal care, are treated more quickly, they have better outcomes, they stay for a shorter length of time in the hospital, they suffer fewer costly readmissions, and have lower mortality and fewer complications overall. This leads to better results for patients, hospitals, and insurers, both on a health and a healthy economic level, as well as substantially improving the quality of life for these patients. Here are some of the operating company financial highlights. Bob earlier spoke about the corporate parent level highlights. Now Daxor reports as a 1940 Act reporting company with consolidated highlights. So all of the operating company results that I'm sharing below come from an unaudited report from our own internal accounting systems. The following financial highlights for the operating division, I'm pleased to report that we met our goal from last year, 12 months prior, of achieving a cash flow breakeven during the first quarter of 2025, not including costs related to stock-based compensation, depreciation, amortization, or CapEx. Revenue in our operating company increased 116.5% year-on-year from 2024 versus the prior year of 2023. Revenue in the first two months of 2025 is over 100% higher than the same two months in 2024. So our momentum and growth substantially continue year-on-year. The number of kits sold in our diagnostic system rose 60.1% year-on-year for 2023. Our similar growth was about 37% in the prior year. So the number of kits sold is increasing rapidly as is obviously the revenue. We signed 12 new accounts in 2024, including five who purchased our analyzer systems. The balance of new accounts were either rentals or leases or the use of our ezBVA lab services. Three new accounts have already been signed in the first two months of 2025, again, with a combination of placement agreements in ezBVA lab services. The operating company increased revenues from the second half of 2024 through additional contracts from the U.S. Department of Defense. We received a $2.5 million contract as matching funds awarded from our capital raise in 2023. That contract pays out on a monthly basis over its two-year duration. Additional funding awards were achieved from Launch Tennessee and the National Institutes of Health in the form of direct grants totaling more than $350,000 alone in the second half. Again, some of those awards pay out over 2024 and into 2025. So we have not realized the revenue from them completely yet. Additional funding awards are really an excellent source of non-dilutive funding for the company, obviously. The FDA reviewed the 510(k) submission for our next-generation analyzer that we submitted at the end of 2023 and to the beginning of 2024. We filed a dual submission, which was a 510(k) submission for both 510(k) and CLIA determination. After working extensively with the FDA and receiving feedback from them, we determined that we wish to withdraw and resubmit that as a sequential package. I'm pleased to share we have successfully completed the additional testing data that FDA asked for in our labs, and we will be imminently submitting that 510(k) submission for its statutory 90-day review period. Daxor will also last year entered into an agreement to acquire the IP from a key supplier to bring manufacturing entirely in-house for Volumex kits and added an additional radiopharmaceutical to our product suite in the form of Glo-fil, which is a kidney function marker. The first two months of 2025, as I just said, are off to an even faster pace of growth versus 2024. And we are continuing to see an acceleration of adoption and use of our systems even prior to the launch of our next-generation systems. February itself was a record-setting sale of monthly kit revenue. And I'm very pleased about these results. I would just like to add because when we made our forecast 12 months ago that we would reach operational cash flow breakeven within the operating company, we anticipated that, that would be fueled by the approval and adoption of our next-generation analyzers. I'll speak more about that in a moment. We were still able to achieve that financial goal even without that system being there, highlighting the substantial value that is already inherent within our existing product suite of offerings. And regarding the next-generation Blood Volume Analyzer, Daxor completed a multicenter study to validate its next-generation analyzer. First, we validated it for the U.S. Department of Defense, which paid largely for the development of this analyzer system. And then we did a multi-center study to validate it, which was completed in Q4 of 2023 and submitted to the FDA under the 510(k) clinical laboratory lumens amendment or the CLIA pathway. Following the statutory six-month review for that dual submission pathway last year, FDA requested additional data to supplement the application. Daxor elected to refile this submission as a single 510(k) for a 90-day review pathway with the intention to file a separate CLIA study in the future. I would like to add that none of the supplemental data that was requested by the FDA in management's opinion was material or related to the question of the accuracy of the equipment itself; there's an extensive amount of data that is required to satisfy the FDA's various different statutory regulations around the approval of a device. So much of this we consider supplemental and non-core information, nevertheless necessary to provide to the agency. In electing to have a single pathway, sequential sequence in other words, first you get the 510(k) and then later to get the CLIA, this pathway is advantageous because it allows for a simpler and significantly time-reduced pathway towards getting an approved and salable product for us. With these supplemental studies now complete, as I just mentioned, Daxor intends to file this new application imminently. This application is really a follow-on to what's already been reviewed by the FDA. This point-of-care blood volume analysis system, developed, as I said, under multiple contracts with the US Department of Defense as well as grants from the National Institute of Health, is a significant leap forward in our market-leading technology. It allows for determination of blood volume at the point of care or the bedside in as low as 15 minutes. The new system has been validated in our study to be as much as three times faster, simpler, battery-powered, and capable of being a full point of care CLIA wave device, although, as I said, a CLIA study will need to be followed to get that waiver. Daxor intends to first secure the 510(k) approval for the device to market at current CLIA designation of moderate complexity. And then a second developmental phase later this year to submit a CLIA study to show that it is eligible for the CLIA waiver designation. For us, it's no exaggeration to say that this next junction analyzer is our most important product launch in 20 years and has the potential to deliver a level of speed, access, accuracy, and convenience to fluid management that can broadly change medicine and find acceptance into workflows at a much greater level than our current lab-based system. Management anticipates that upon approval, there will be significant interest and uptake of the new system based upon preliminary discussions with clinicians, helping to develop the technology, as well as an increase in disposable kit sales driven by the speeding convenience of the new system. The speed and convenience of the new system will open additional points of use in the hospital and outpatient settings, leading to significant growth as a result, as well as other verticals within the hospital system. Daxor's next-gen devices will also be eligible for Phase III funding awards and acquisition by branches of the military for their deployment to aiding Combat Casualty Care, as well as further developmental contracts. It would be an honor for the company to help in the sphere of military medicine and Combat Casualty Care. Strategic acquisition and new product launch of an additional diagnostic radiopharmaceutical is also part of Daxor's strategic plan for 2025, when we entered into this definitive agreement in March of 2024 to acquire the exclusive worldwide rights and IP to manufacture Volumex and Megatope from Iso-Tex diagnostics. We also received the rights to a second radiopharmaceutical drug, Glofil, that measures glomerular filtration rate. These acquisitions are expected to be immediately cash flow positive and accretive to earnings due to internalized production and higher margins. The actual plans are to bring the manufacture of these diagnostics in-house at its Oak Ridge facility, which will increase margins on its bloodline analysis test kits. Acquiring Glofil provides stats with a new product to cross-sell to its growing customer base, particularly in hospitals where Glofil is already used. The deals are structured with favorable solid provided financing with payments made for manufacturing transition completed in six months to nine months, followed by monthly installments over a two-year period. This transaction is subject to regulatory approvals and other customary conditions. For the research patents and clinical outcomes, I can speak to the fact that from Q1 of 2024 through the first two months of 2025, research utilizing BVA has appeared to more than a dozen peer-reviewed conferences or publications, as Dr. Jefferies alluded to. The data has highlighted the increasing utility of BVA in cardiorenal syndrome, often covering diagnoses in heart failure patients and the superiority of BVA versus commonly used proxy measures. The key strategy of the company to continue our efforts to encourage not only the clinical use but also the academic study of the health and health economic outcomes related to the use of blood volume analysis technology. At the root of better outcomes is the best diagnosis of the patient, something that BVA has been shown to be uniquely capable of. In closing summary, I will say that the strong trend of healthcare is towards individualized care and cost-effectiveness. We live in a value-based world. Our BVA diagnostic non-invasive, relatively inexpensive and rapid blood test allows care teams to solve one of the most significant and challenging problems in medicine, which is how to accurately manage the fluid levels of patients in a wide variety of settings. Reducing mortality, lowering complications, reducing hospital resource use and length of stay with a non-invasive 98% accurate test is achievable with our patented technology, as well as optimizing care for patients in the outpatient setting. The competitive areas of healthcare are having achieved reimbursement for technology from both public and private payers a strong competitive advantage that we have achieved, in addition to the increase in clinical evidence and the commercial potential of what we've developed. Just as exciting is the next generation of products that are in development pipeline slated for completion this year, which should further enhance the accessibility of our tests and open up both government as well as civilian hospital systems on an international scale. Note, Daxor has been reporting as an investment company under the Investment Company Act of 1940 since January 1, 2012. See the notes to our financial statements on the Form N-CSR for further information on Daxor strategies and goals relating to its investments in publicly traded securities that fund its diagnostic operations. Because of its holding publicly traded securities, the SEC currently classifies Daxor as a closed-end management company with a fully owned medical operating division. However, the primary focus of management is on our operational objectives. Daxor anticipates that as the value of the operating company has significantly increased as reflected in our financial statements relative to the percentage of listed securities owned, which has fallen as is also reflected in our financial statements, that we should be able to file under our prior 1934 Act designation as an operating company. The goal for management is to secure this designation before the end of 2025, and we are in active discussions with the Securities and Exchange Commission around how to affect the filing change. One question that's often asked amongst many questions that have been given is why are Daxor's shares trading at what seems to be a relatively modest valuation or discount to fair market value. Management believes that with the coming transparency of our reporting, meaning from the transition from a 1944 Act company, the milestones for our next-generation systems, and the continued momentum around revenue growth and adoption of our systems, the valuation of the company may start to reflect the tremendous value and market potential of our diagnostic technology, which has broad utility in over 7 million heart failure patients in the US alone, as well as several million patients in the critical care and surgical space, and several more million patients who have various different ambulatory conditions, such as syncope and POTS, many other conditions, which would all benefit significantly from the use of BVA. So with that being said, I wish to enter the chat to see if there are any Q&A that we can answer. The answer to both of those questions is yes. So the company parent, at the parent level, did transfer $1.6 million to the operating company to cover capital expenditure, inventory build, research and development, in addition to the various other operations of the operating division. So we don't break out due to our consolidated filing status as a 1940 company, the delineation between all of these various different categories. So that audited results as a net cash transfer between the two. As we stated earlier in the first two months of 2025, net of CapEx, depreciation, amortization, and shareholder and share-based compensation expense, our operating company has been operating in a cash flow positive state. So we're quite happy about that, and it's been driven substantially by the significant revenue growth and the increase in pricing that the company has been able to achieve. See if there's any additional questions to speak to. Okay. Can you speak to your efforts to build the sales team to drive the placement of the device? We continue to build our commercial teams. We think that they're quite competitive. And we've seen very effective growth within that area. We've been able to realize substantial value from communicating to our various different customers based upon the strength of our unique technology. And of course, the really deep results that have been associated with guiding care. So we are going to continue to build for a combination of internal hires and then potentially distributor agreements with third parties as well. Looking at the questions. Please discuss the competitive landscape. I believe that the competitive landscape in the United States and globally around the care volume management is focused largely on a number of indirect proxy measures, many of which are, as I stated earlier, not particularly accurate or effective at managing care. Daxor has been able to pioneer a far more accurate gold standard method of directly measuring volume as well as capillary permeability. And we believe that it leads to a substantial amount of competitive advantage for us. That concludes the calls that we have now and the time that we have for questions. I will turn it over to Natalie. Thank you very much. In conclusion, I would like to thank all of the shareholders for their continued support. We look forward to sharing additional accomplishments and developments as they unfold. Thank you all for participating in today's call, for your interest in Daxor. We wish you all a very good day.
