Daxor Corp Q4 FY2023 Earnings Call

Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to the Daxor Corporation Conference Call for the Corporate Update and Financial Results for the Year 2023. At this time, all participants are in a listen-only mode. After today’s presentation, there will be an opportunity to ask questions. During this call, management will be making forward-looking statements, including statements that address Daxor's expectations for future performance or operational results. Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those statements. For more information about these risks, please refer to the risk factors described in Daxor's most recently filed annual report on Form N-CSR and subsequent periodic reports filed with the SEC and Daxor's press release that accompanies this call, particularly the cautionary statements in it. These reports are available on daxor.com. The content of this call contains time-sensitive information that is accurately only as of today, March 25, 2024. Except as required by law, Daxor disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call. It is now my pleasure to turn this call over to CEO and President, Michael Feldschuh.

Thank you, Natalie, and good afternoon, everyone, and welcome to the Daxor Annual Shareholder Call. I would like to turn the floor over to our Chief Financial Officer, Robert Michel for some highlights from our financial performance. Bob?

Thank you, Michael, and good afternoon, everybody. Here's a summary of our fiscal 2023 financial results. For the year ended December 31, 2023, Daxor's net assets increased 17.4% to $34,10,384 or $7.08 per share as compared to $28,969,469 or $6.75 per share at December 31, 2022. Valuation of the operating division increased $6 million to $32 million at December 31, 2023, from $26 million at December 31, 2022. The increase during 2023 is based on an annual independent valuation performed for the year ended December 31, 2023, utilizing a hybrid of methods of the income approach using the discounted cash flow method and the market approach realizing recent arm's length transactions. In 2023, $464,599 Daxor treasury shares were sold at a price of $9.75. The discounted cash flow realized 35% of this weighting on the income approach and utilized 65% weighting on the market approach. For the year-end December 31, 2023, Daxor had net dividend income of $157,378. Net realized gains on investment activity were $603,774. There was a net decrease in unrealized depreciation on investments of $885,199 as we sold long-held positions during the year 2023, from which prior year's significant unrealized gains unwound into realized gains for the period. Included in the net increase in net assets resulting from operations of $280,640 is a non-cash stock-based compensation expense of $631,701. In an effort to provide incentive to employees, officers, agents, and consultants to the company, we utilized stock-based incentive awards. Daxor invested $4,552,380 in the operating division relating to our continued investments in research and development, sales, overhead as the company continues to invest judiciously for our anticipated 2024 product launch, ramping the commercial sales teams as well as production facilities for our next-generation blood volume analyzers. That concludes my summary of the financial results. And now, I'd like to turn the call back to Michael. Thank you.

Thank you, Bob. I appreciate it. So I'm going to give a general update on the company. A number of investors and other interested parties have thoughtfully submitted a series of questions for me to address after that. In addition, it's possible to type in questions that you wish to the moderator, who can then pass them on to me. Unfortunately, due to the very large volume of questions that we've received and the time allotted for this, I can't get to every single person's question, but I will try to cover a lot of ground and hopefully, that will satisfy people's need for more details. So let's just start at the top. This is an incredibly exciting time for Daxor right now. A number of different things are all converging, things that we've been working on for years, things that are critical to our development as a company, as an ongoing concern that is committed to changing the arc of health care and specifically to solving one of the largest challenges in medicine, which is effective blood volume management to enable optimal care. So I'll just start by saying that we have never been more focused on our mission and our goals than we are right now. Every team member at Daxor sees both remarkable strides that we're making in these different areas, and I'm going to go into those details in a moment. We really feel that we are solidifying our position not only as the global leader in blood volume measurement technology but we're rapidly seeing just how fast this market is growing and the promise of what our rapid expansion means both for the company and for the potential for serving the tens of millions of patients that exist in the market globally that would benefit from optimized care through better blood volume measurement. For 2023, we've seen a very strong start with continued growth of our revenues from 2022 to 2023 and into the start of 2024. We've been able to hit a number of key milestones and objectives from last year, including submitting our next-generation blood volume analyzer for consideration under the 510(k) approval process with the FDA, something that we did at the end of Q4. We've received a number of new patents, and those are very important as we have a growing family of patents around our technology, which will protect our lead in the marketplace for years. We have a number of patents pending as well. We've been the recipient of awards from both the National Institutes of Health and further contract awards from the U.S. Department of Defense, which are not only wonderful for their non-dilutive funding but also because they are such strong validation of the value of our technology and the importance of the problem that we're solving and the effectiveness of the solution that we present. So with that being said, why don't I dive into a little bit more about what we're doing. Briefly, I'll say that blood volume measurement is a key indicator that is essential for improving and optimizing patient care. While not all investors are familiar with why that is such a vital sign, I'll briefly explain that while the pressure and the temperature of a patient's blood can be easily determined, even the ratio of red cells to plasma can be easily ascertained, knowing and quantifying the actual total amount of blood that a patient has has been one of the major challenges in modern medicine. Daxor has a 98% accurate gold standard method of solving this problem, and the reason why that matters is because blood volume is vital for improving patient outcomes. Every single intervention in medicine that involves a transfusion, the use of a diuretic, or any supportive fluid management decision is fundamentally a blood volume management question. The problem has been that while we've had a wide variety of interventions to guide blood volume management, there have been many suboptimal outcomes for patients due to the lack of effective measurement of their actual volume. This has profound implications for both chronic and acute conditions that require hospitalization. It involves patients on the inpatient side and those on an outpatient setting as well. When you look at the vast number of patients requiring volume management interventions, this includes 6 million individuals with heart failure, 1 million of whom will be hospitalized this year. One in five patients will die from heart failure—one of the leading causes of death in the United States. This issue extends to the large number of patients who undergo volume-effective therapy for hypertension, which involves around 120 million patients annually. So, if Daxor has such a massive market, what has been our strategy to create effective inroads? I will get into that momentarily, but I wanted to set the stage regarding why this is urgent. It's not just enough to showcase a more accurate diagnostic; we must also demonstrate how care guided by that accuracy leads to better outcomes—clinical, economic, or quality of life. The good news is that in Daxor's case, effective care that begins with very accurate diagnosis leads to improvements across all these metrics. This means reduced hospital stays, lower readmission rates, and decreased mortality rates, thus yielding more efficient results for providers. Consequently, hospitals will spend less treating these patients, resulting in insurance companies and payers being responsible for less as well—a noteworthy achievement for Daxor. Bob, of course, highlighted the good financial numbers, but I would like to elaborate on our operational cadence and improvements. Specifically, between the second half of 2022 and the second half of 2023, we've observed our kit sales rise by 437.4%. This denotes the number of tests sold. Our tests or test kits are sold either shipped to hospitals for immediate use or as a reference lab service where samples are sent back to Daxor's certified lab for reporting results. The pricing for our tests in 2023 was $385 per kit, which has since increased to $460 per test, effective March 1. Meanwhile, we introduced an ezBVA lab in 2023, where the injected tracer is sent to hospitals while blood samples are processed at Daxor’s lab. This has been priced at $965 per test, with an increasing customer uptick. In the first two months of 2024, we saw over a 95% increase in the number of kits sold compared to 2023. Our sales have risen thanks to a combination of growth at existing accounts and added new accounts—12 hospital accounts in 2023, and six in the first two months of 2024. We've seen a significant pivot in sales and customer engagement since the third quarter of last year, which has been surprising. Despite concerns from investors that a new system was forthcoming, adoption of our technology has accelerated with a 95.7% year-over-year increase in the first two months of the year. We had our best week of kit sales last week and anticipate breakeven within 12 months, driven by ongoing growth in adoption. We completed a clinical trial last year at several sites comparing lab results from our existing FDA-cleared BVA-100 system with the next-generation blood volume analyzer. This involved several hundred samples from patients in real hospital conditions, submitted in a 550-page document to the FDA for their 510(k) and CLIA waiver approval. We are quite pleased with the data collected, validated with the Department of Defense under contract, and are now ready to proceed with civilian validation. This new system, which is portable and battery-operated, is about the size of a shoebox and has been designed for rugged conditions. Its significant development advances the ease of use for both military and civilian applications. The workflow allows immediate processing of blood samples at the bedside, significantly reducing result wait times from 60-90 minutes to as quickly as 15 minutes. This is critical for timely interventions in critical care units, enhancing the system's appeal to hospitals. Furthermore, we're pursuing CLIA waiver certification to facilitate easier adoption. This will not only attract existing customers but also open up new accounts interested in the speed, convenience, and accuracy we offer. Our research and development continue to receive support from the U.S. military for our next-generation tracer, along with patents related to blood volume technology. We've seen a surge in interest with over 25 peer-reviewed papers and presentations in the last 18 months, reflecting the growing recognition of blood volume analysis. As definitely shown in two randomized controlled trials—one from Duke and another from the VA center—both pilots indicated a troubling 70-50% error rate in clinician assessments of patient blood volume, underlining the urgent need for accurate measurement. To wrap up, we’ve seen excellent momentum regarding the 2023 results, with our next-gen analyzer advancement being pivotal. We submitted our 510(k) to the FDA at the end of Q4, currently around 85 days into a 180-day review process. Although we cannot predict the exact timing of the review, preparations are in place for manufacturing units once we gain clearance. The announcement from this morning regarding our acquisition of Iso-Tex Pharmaceuticals is significant. We aim to bring manufacturing of critical products in-house, allowing us to leverage our existing facility and scale operations without additional capital investments. This will enhance our margins, expected to rise a minimum of 15% for our products, with significant capacity to meet increasing demand.

I’d just like to thank everybody for joining the call. As Michael said, as we reached these milestones, we will be making announcements for the path forward. It’s a very exciting time to be at Daxor and to be an investor at Daxor. So thank you very much for your support.