Full Year 2024 Daxor Corp Earnings Call
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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 <unk> and where we're at as we forge ahead into what we consider really a pivotal year tax or remains laser focused on our mission. We are unwavering in our pursuit of our strategic goals were fueled by a relentless determination for anomaly transformative growth of the company, but also 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 in every year during 2024, and we've had a really strong start to 2025 I am pleased to report that there has been substantial progress for the company in.
Speaker Change: And revenue growth.
Speaker Change: Customer acquisitions, increasing utilization of our products by existing customers strategic agreements to acquire key supplier next generation systems under food and drug Administration review.
Speaker Change: Positive clinical trial results patents pending and granted successful NIH Grant awards.
Speaker Change: Contracts awarded and further R&D for groundbreaking product set to launch and subsequent fiscal years, we have a very rich and robust pipeline.
Speaker Change: 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 that's where his focus on profoundly improving outcomes for the tens of millions of patients as well as the hospital systems, and the Payors, which support that system by solving a central problem of medicine.
Speaker Change: Now 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.
Speaker Change: Talking about heart failure sepsis post surgical blood loss and think of Pizza site, but a few this urgent medical need has long been hampered by the use of oxy or surrogate markers not direct measurement of blood volume.
Speaker Change: Any of these markers are costly somewhere invasive none are accurate in contrast to <unk> proven 98% accurate system care teams fundamentally cannot effectively treat with they don't accurately diagnose so.
Speaker Change: 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.
Speaker Change: This leads to better results for patients hospitals and insurers, both on health and the health economic level as well as substantially improving the quality of life for these patients.
Speaker Change: Here are some of the operating company financial highlights Bob earlier spoke about the corporate parent level highlights now tax will reports as $19 40 Act reporting company with consolidated highlights so all of the.
Speaker Change: Operating company results that im sharing below come from an unaudited reports from our own internal accounting systems. Following financial highlights for the operating Division I am pleased to report that we met our goal from last year 12 months prior of achieving cash flow breakeven during the <unk>.
Speaker Change: Quarter of 2025, not including costs related to stock based compensation depreciation and amortization or capex.
Speaker Change: 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 continues year on year.
Speaker Change: On Europe, the number of kits sold in our diagnostic system rose 61% year on year for 2023 are similar growth was.
Speaker Change: About 37% in the prior year. So the number of kits sold is increasing rapidly as is obviously the revenue.
Speaker Change: We signed 12, new accounts in 2024, including five who purchased our analyzer systems with balanced.
Speaker Change: New accounts.
Speaker Change: Either rentals.
Speaker Change: Or leases or the use of our <unk> BVA lab services three new accounts have already been signed in the first two months of 2025 again with a combination of placement agreements in ECP gave lab services operating company increased revenues from the second half of 2000 2004 through additional contracts from the U S Department of Defense, we received a two.
Speaker Change: $5 million contract as matching funds award 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 $350000 alone in the second half.
Speaker Change: Again, some of those awards payout over time.
Speaker Change: <unk> 2024 and into 2025.
Speaker Change: So we have not realized the revenue from them completely yet additional funding awards.
Speaker Change: Or really a.
Speaker Change: An excellent source of non dilutive funding for the company obviously the.
Speaker Change: FTA reviewed the 500 10-K submission for our next generation analyzer that we submitted at the end of 2023 into the beginning of 2024.
Speaker Change: We received we filed a dual submission which was a five 10-K submission for both 500 10-K, a clear determination after working extensively with the FDA we.
Speaker Change: Determined and receiving feedback from them, we determined that we wish to withdraw and resubmit that has a sequential package.
Speaker Change: We.
Speaker Change: I am pleased to share have successfully completed the additional testing data.
Speaker Change: The FDA asked for in our labs, and we will be imminently submitting that five 10-K submission for its statutory 90 day review period.
Speaker Change: <unk> also last year entered into an agreement to acquire the IP from a key supplier to bring manufacturing entirely in house for volume ex kits and added an additional radiopharmaceutical to our product suite in the form of <unk>, which is a kidney function marker.
Speaker Change: The first the first two months of 2025 as I, just said are off to an even faster pace of growth.
Speaker Change: 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.
Speaker Change: 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 meet our forecast 12 months ago that we would reach operational cash flow breakeven within the operating company.
Speaker Change: 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.
Speaker Change: Already inherent within our existing product suite of offerings.
Speaker Change: And regarding the next generation blood volume analyzer.
Speaker Change: <unk> completed a multicenter study to validate its next generation analyzer first.
Speaker Change: Validated it for the U S Department of defense, which paid largely for the.
Speaker Change: Development of this analyzer system and then we did a multicenter study to validate it.
Speaker Change: Which was completed in Q4 of 2023 and submitted to the FDA under a 500 10-K clinical laboratory <unk> Amendment are the clear pathway.
Speaker Change: Following the statutory six month review for that dual submission pathway last year FDA requested additional data to supplement the application.
Speaker Change: <unk> elected to Refile. This submission as a single five 10-K for a 90 day review pathway with the intention to file a separate clear.
Speaker Change: The study in the future I would like to add that none of the supplemental data that was requested by the FDA in managements opinion was material or related to the question of the accuracy of the equipment itself.
Speaker Change: There is an extensive amount of.
Speaker Change: 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.
Speaker Change: In electing to have a single pathway sequential sequence in other words first to get the 500 10-K, and then later to get the clear. This pathway is advantageous because it allows for a simpler and significantly time reduce pathway towards getting <unk>.
Speaker Change: <unk> and saleable product for us with the supplemental study is now complete as I just mentioned <unk> intends to file this new application imminently. This application is really a follow on to what's already been reviewed by the FDA.
Speaker Change: This point of care blood volume analysis system developed as I said under multiple contracts with the U S Department expenses, most grants from the National which itself is a significantly forward in our market leading technology allows for determination of blood volume at the point of care or the bad tightened as little as 15 minutes New system has been validated in.
Speaker Change: Our study to be as much as three times faster simpler battery powered and capable of being a full point of care CLIA waived device, although as I said, a clear study wouldn't be followed.
Speaker Change: To get that waiver, that's where intends to first secure the five 10-K approval for the device to market at its current CLIA designation of monarch complexity.
Speaker Change: And then a second developmental phase later this year submit a clear study to show that it is illegal for the CLIA waiver designations for US it's no exaggeration to say that this next generation 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.
Speaker Change: <unk> medicine and final acceptance into workflows that a much greater level that our current lab based system.
Speaker Change: Management anticipates that upon approval that will be significant interest and uptake to the new system based upon preliminary discussions with questions, helping to develop the technology as well as an increase in disposable kit sales driven by the spin.
Speaker Change: System.
Speaker Change: The speed and convenience of the new system will open additional points of use in the hospital and outpatient setting some of them.
Speaker Change: Paramount should see significant growth as a result, as well as other verticals within the hospital system. Baxter's next generation devices will also be eligible for phase III funding awards and acquisition by breakfast military for their deployments of heating 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 in combat casualty care.
Speaker Change: Strategic acquisition and new product launch of an additional diagnostic radiopharmaceutical is also part of <unk> strategic plan for 2025.
Speaker Change: When we entered into this definitive agreement in March of 2004 to acquire the exclusive worldwide rights and IP to manufacturer <unk> Mega Taupe from Isoetec diagnostics. We also received the rights to a second radiopharmaceutical drug <unk> that measures corner filtration rate.
Speaker Change: These acquisitions are expected to be immediately cash flow positive and accretive to earnings due to internalize production higher margins actual plans to bring the manufacturer of these diagnostics in house at its Oak Ridge facility, which will increase margins on its blood volume analysis test kits.
Speaker Change: Global provide stacks, where the new product cross sell to its growing customer base, particularly in hospitals, where <unk> is already used the deals are structured with favorable solar provided financing with payment is not due until the manufacturing transition is completed in six to nine months, followed by monthly installments over a two year period. This transaction is subject to regulatory approvals and other customary condition.
Speaker Change: <unk> for the research patents and clinical outcomes I can speak to the fact that from Q1 of 2004 through the first two months of 25 research utilizing BVA is appear to more than a dozen peer reviewed conferences publications as Dr. Jeffrey has alluded to the data as highlighted the increasing utility of PVA and cardio renal syndrome, covering off the misdiagnosis heart failure patients and the superiority.
Speaker Change: PVA versus commonly as proxy measures. It's a 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 patient something that PVH has been shown to be capable of.
Speaker Change: In closing summary, I will say that the strong trend of health care is towards individualized care and cost effectiveness, we live in a value based world our BVA diagnostics, a noninvasive relatively inexpensive and rapid blood test, which allows care teams to solve one of the most significant and challenging problems in medicine, which is how to accurately manage the fluid levels.
Speaker Change: The patients in a wide variety of settings as I've alluded to.
Speaker Change: Reducing mortality lowering complications reducing hospital resource use and length of stay with a noninvasive and 98% accurate test is achievable with our patented technology as well as optimizing care patients in the outpatient setting the competitive areas of health care, having achieved reimbursement for technology from both public and private payers is a strong competitive.
Speaker Change: <unk> that we have achieved.
Speaker Change: 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 I've alluded to which should further enhance accessibility of our tests and open up to both governance Australian Hospital systems on an international scale.
Speaker Change: Note tax where has been reporting as an investment company under the investment Company Act of 1040 since January one 2012 see the notes to our financial statements.
Speaker Change: On the form and CSR for further information on tax strategies and goals relating to its investments in publicly traded securities to help fund its diagnostic operations.
Speaker Change: Because of its holding in publicly traded securities of the SEC currently classify as stacks or has it closed and management company with a fully owned medical operating Division. However primary focus of management is on our operational objectives <unk> anticipates that the.
Speaker Change: 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 Gulf of management is to secure this designation before the end of 2000.
Speaker Change: <unk> 25, and we are in active discussions with the Securities and exchange Commission around how to affect the filing change.
Speaker Change: One question, that's often asked amongst many questions that have been given is why our <unk> shares trading at what seems to be a relatively modest.
Speaker Change: Evaluation or discount to fair market value.
Speaker Change: Management believes that with the coming transparency of our reporting.
Speaker Change: Meaning from the transition from a 940 <unk> hundred 30 for our company and the milestones of our next generation systems and the continued momentum around revenue growth and adoption of our systems valuation of the company may start to reflect the tremendous value and market potential of our diagnostic which has broad utility and over 7 million heart failure patients in the U S alone is worth several million patients.
Speaker Change: Since in the critical care and the surgical space and several more million patients who have various different ambulatory conditions, such as syncope and parts. Many other conditions, which would all benefit significantly from the use of PVA.
Speaker Change: So with that being said.
Speaker Change: I wish to.
Speaker Change: Enter the chat to see if there's any Q&A.
Speaker Change: We can answer.
Speaker Change: Alright, I don't see any additional questions. We tried to speak to a number of questions that we received prior to the call. One additional question that I'll speak to is there was a question that was submitted to us.
Speaker Change: Around our financial statements. It said there was an investment of 1 million $614124 into the operating division relating to spending on research and development and sales overhead. This is a newer exactly what is reported unrealized loss and operating division does this realized loss amount include Capex does include spending on inventory answered too.
Speaker Change: Both of those questions is yes, so the company parent at the parent level did transplant $1 $6 million to the operating company to cover capital expenditure inventory build research and development.
Speaker Change: In addition to the various.
Speaker Change: Other operations of the operating division. So we don't break out due to our consolidated filing status as the 19 forties at company B delineation between all of these various different categories.
Speaker Change: So that that audited results is a cat as a net cash transfer between the two as we stated earlier.
Speaker Change: In the first two months of 2025.
Speaker Change: Net of Capex, depreciation and amortization and shareholder and share based compensation expense. Our operating company has been operating in a cash flow positive state.
Speaker Change: So we're quite happy about that and it's been driven substantially by the significant revenue growth and the increase in pricing, which the company has been able to achieve.
Speaker Change: See if theres any additional questions to speak to.
Speaker Change: Okay.
Speaker Change: Can you speak to your efforts to build the sales team to drive the placement of the device.
Speaker Change: <unk>.
Speaker Change: We continue to build our.
Speaker Change: Our commercial teams, we think that they are quite competitive.
And we've seen very.
Speaker Change: The effective growth within that area.
Speaker Change: We've.
Speaker Change: 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.
Speaker Change: Guiding care. So we are going to continue to build through a combination of internal hires and then potentially.
Speaker Change: Distributor agreements with third parties as well.
Speaker Change: Looking at the questions. Please discuss the competitive landscape I believe that the competitive landscape in the United States and globally around the care of volume management is focused largely on a number of indirect proxy measures.
Speaker Change: Many of which are as I stated earlier, not particularly accurate or effective at managing care.
On tax or.
Speaker Change: Has been able to pioneer a far more accurate gold standard method of directly measuring volume as well as capillary Walt permeability and we believe that it.
Speaker Change: 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.
Speaker Change: I'll turn it over.
Speaker Change: Two.
Speaker Change: Italy, let me see.
Speaker Change: Okay.
Speaker Change: Okay. Thank you very much so in conclusion I would like to thank all 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 <unk>. We wish you all a very good day. Thank you.