Daxor Corporation (Nasdaq: DXR), the global leader in blood volume
measurement technology today issued a corporate update in a Letter
to Shareholders filed in its certified shareholder report on Form
N-CSR on March 15, 2023 from CEO & President, Michael
Feldschuh.
Dear Fellow Shareholder:
"Concentrate all your thoughts upon the work in
hand. The sun's rays do not burn until brought to a focus." -
Alexander Graham Bell
We have never been more focused on our mission
and goals. Every team member at Daxor sees both the remarkable
strides the company has made over the past year solidifying its
position as the global leader in blood volume measurement
technology and the promise of what our rapid expansion means for
both the company and the tens of millions of patients whose care we
are eager to significantly improve. In every area 2023 and the
strong start of 2024 has shown substantial progress for the company
-- in revenue growth, new customer acquisitions, increasing
utilization of our products by existing customers, next generation
systems completed and under Food and Drug Administration (FDA)
review, positive clinical studies, new patents granted and pending,
successful National Institutes of Health (NIH) grant awards,
Department of Defense (DoD) contracts awarded, and further research
and development for groundbreaking products set to launch in
subsequent fiscal years. I will detail below more in these areas
but first wish to review why our company’s mission to commercialize
the products that enable optimal patient care is so vital.
Our Mission: Optimal Blood Volume for
All
Daxor is focused on profoundly improving
outcomes for tens of millions of patients as well as the hospital
systems and the payers which support the system, by solving a
central problem of medicine – providing highly accurate,
convenient, and rapid knowledge of patient blood volume. Managing
blood volume is the cornerstone of care for some of the largest
areas of patient care – heart failure, sepsis, post-surgical blood
loss and syncope to cite a few, but this urgent medical need has
long been hampered using proxy or surrogate markers, not direct
measurement, of the blood volume. Many of these markers are costly,
some are invasive, and none are accurate – in contrast to Daxor’s
proven 98% accurate system. Care teams cannot effectively treat
what they do not correctly diagnose, so our rapid accurate
diagnostic test is a game-changer. Every metric that matters is
impacted from this first principle of accurate diagnosis – patients
receiving optimal care are treated more quickly with better
outcomes, have a shorter length of stay in the hospital, suffer
fewer costly readmissions, and have lower mortality and fewer
complications overall. This leads to better results for patients,
hospitals, and insurers on both a health and economic level.
Financial Strength and Increase in Net
Asset Value
As of December 31, 2023, Daxor’s net assets were
$34,010,384 or $7.08 per share as compared to $28,969,469, or $6.75
per share on December 31, 2022. The increase in the net asset value
is primarily due to the continued appreciation in value in the
operating division. The valuation of the operating division
increased $6,000,000 to $32,000,000 on December 31, 2023. For the
year ended December 31, 2023, Daxor had a net dividend income of
$157,378, net realized gains on investment activity of $603,774.
There was a net decrease in the unrealized appreciation on
investments, options and securities borrowed of $885,199. As we
sold positions during 2023, prior period’s significant unrealized
gains unwound into the gains for the period. Included in the Net
Increase in Net Assets Resulting from Operations of $280,640 is
non-cash stock-based compensation expense of $631,701, to provide
incentive to employees, officers, agents, and consultants through
proprietary interest in the company. There was an investment of
$4,552,380 into the operating division relating to spending on
research, development, sales and overhead as the Company continues
to invest judiciously in research and development for our 2024
product launch, ramping the commercial sales teams, as well as
production facilities and inventory for our next generation blood
volume analyzers.
Unaudited Operating Company Results:
Increasing Revenue, Sales, and New Accounts
- Revenue increased
31.8% Year on Year for 2023 versus 2022
- Revenue in the first 2 months of
2024 has increased 220% Year on Year versus 2023
- Number of Kit sold for our
Diagnostic System rose 36.2% Year on Year for 2023 versus 2022
- Kit revenue in the first 2 months
of 2024 has increased 95.7% Year on Year versus 2023
- 12 New Accounts launched in 2023,
with a combination of sales, rentals, and ezBVA Lab services
- 6 New Accounts launched in the
first 2 months of 2024, with a combination of sales, lease, and
ezBVA Lab services
- New pricing for kits of $460 per
dose starting in March of 2024
- The operating company increased
revenues from the second half of 2023 through additional contracts
from the DoD, receiving a 2 year, $1.1M contract and is under
consideration for an additional $2.5M of contracts by end of Q2
2024
- Management
forecasts break-even for the operating company within 12 months if
anticipated next gen units are cleared by FDA for sale, new
contracts, and sales growth continues
Contributing to growth was the launch in June of
2023 of Daxor’s ezBVA Lab service for clinical sites that wish to
perform blood volume analysis (BVA) testing utilizing the Company’s
lab services for samples collected without the need for an on-site
analyzer. This new service, priced at $965 per test, represents a
significant value for customers and is a premium to the sale of
test kits which sold for $385. In addition, this new service has
helped to accelerate the opening of new accounts and increased the
rate of revenue growth as well. As the statistics show, 2024 is off
to an even faster pace of growth on all fronts as we see an
acceleration of adoption and use of systems even prior to the
launch of our next generation systems.
Next Generation Blood Volume Analyzer
System
Daxor completed a multi-center study to validate
its next generation blood volume analyzer in Q4 of 2023 and
submitted it for review with the FDA at year-end under a
510(k)/Clinical Laboratory Improvements Amendments (CLIA) - waiver
dual submission pathway. This point-of-care blood volume analysis
system, developed under multiple contracts with the DoD, as well as
grants from the NIH, is a significant leap forward in our
market-leading technology allowing for a blood volume determination
at the bedside in as little as 15-minutes. This new system has been
validated in our study to be three times faster, simpler, battery
powered and capable of being a full point-of-care CLIA-waived
device. For us, it is no exaggeration that this next generation
analyzer is our most important product launch in twenty years and
has the potential to deliver a level of speed, access, and accuracy
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 systems based
upon preliminary discussions with clinicians helping to develop the
technology, as well as an increase in disposable kit sales driven
by the speed and convenience of the new system. The speed and
convenience of the new system will open additional points of use in
the hospital and outpatient setting. Indications such as critical
care, where the speed of results is paramount, should see
significant growth as a result. Daxor’s next generation devices
will also be eligible for Phase III funding awards and acquisition
by branches of the military for their deployment to aid in combat
casualty care as well as further development contracts.
Further Research, Patents, and Clinical
Outcomes
Equally important is the progress that Daxor has
made in clinical outcomes utilizing our blood volume analyzer. In
Q2 2024 the results of a pilot Randomized Control Trial (RCT) in
heart failure patients with BVA guided treatment were published in
the prestigious Journal of the American College of Cardiology by
researchers from the Duke Clinical Research Institute. This RCT
documented that an astonishing 68% of heart failure patients were
misdiagnosed regarding their volume status and that care teams were
ineffective at adjusting these derangements prior to discharge. The
researchers citing the outcomes called for funding of a large-scale
trial centered around BVA technology because of their findings. In
Q3 2024 a Phase I RCT from two Veterans Administration hospitals
under NIH funding reported comparable results to the Duke trial –
that 70% of patients’ total volume or red cell volume was
misdiagnosed absent a BVA test. These results are additional
objective evidence of the scale of the problem that BVA can
solve.
Since the start of 2023, over a dozen new
research studies on BVA have been published in peer-reviewed
journals or at society conferences. These studies importantly
highlighted that BVA can reduce hospital length of stay by 2.6 days
on average for heart failure patients, a significant savings, while
also improving clinical outcomes. Data on the value of BVA for use
in Left Ventricular Assist Device (LVAD) patients and its
superiority to pressure-based cardiac implantable devices are also
highlights of data that researchers from a variety of institutions
published. Regarding recognition and awareness of these
developments, a landmark session at the Heart Failure Society of
America in 2023 marks the second year in a row that the Annual
Meeting will focus on blood volume measurement to improve heart
failure care. Last year’s meeting was attended by hundreds of
physicians which posited that Daxor's BVA provided uniquely
valuable data for congestion management, superior utility to
existing standards of care of pressure-based measures, and that
further study and adoption of it was supported by the growing body
of evidence. Sessions of this nature were led by Key Opinion
Leaders comparing volume versus pressure measures, representing the
growing awareness and substantial need for BVA as an innovative
diagnostic to improve heart failure care. Management is pleased at
the strong and growing reception that our technology is receiving
at these events in special sessions that are not sponsored by Daxor
in any way.
Daxor has also received two patents in the past
quarter relating to the use of BVA to guide care and has several
more patents pending. The family of patents relating the use of BVA
and integrating it for optimal care is a focus of the company to
add value to and protect our innovation. The company also has an
active R&D effort including next-generation tracer technology
which has been recognized by the NIH and is now supported by its
Catalyze Program offering non-dilutive support for its
development.
In Memoriam
It is with a heavy heart that I must report that
Mr. Jim Lombard, a director of the Company who served on the board
of directors for over twenty years, passed away at the age of 89
last October. Mr. Lombard was smart, dedicated, affable, and quick
with a story or recollection to give perspective on the issues at
hand before the board.He will be missed, we thank him for his
contributions to our mission to improve the lives of patients
everywhere and send our condolences to his family.
Summary
The strong trend of healthcare is toward
individualized care and cost-effectiveness. Our BVA diagnostic is a
non-invasive, inexpensive, and rapid blood test which allows care
teams to solve the significant challenge of accurately managing the
fluid levels of patients, whether it is in the heart failure clinic
(outpatient) or the hospitalized heart failure patient or in the
ICU, and studies published and presented are proving just how
exciting the potential for this approach is. Reducing mortality,
lowering complications, reducing hospital resource use and length
of stay with a non-invasive and 98% accurate test is achievable
with our patented technology. In the competitive area of
healthcare, having achieved reimbursement for our technology for
both inpatient and outpatient use is a strong competitive advantage
that will drive our adoption in step with our increasing clinical
evidence and commercial teams. Just as exciting is the next
generation of products that are in our development pipeline slated
for completion this year which should further enhance the
accessibility of our test and open it up to both government as well
as civilian hospital systems on an international scale.
Daxor has been reporting as an investment
company under the Investment Company Act of 1940 since January 1,
2012. See the Notes to the Financial Statements of Form N-CSR for
further information on Daxor’s strategies and goals regarding its
investments in publicly traded securities to help fund its
diagnostic operations. Because of its significant holding of
publicly traded securities, the SEC currently classifies Daxor as a
closed-end investment 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 continues to increase as a percentage of
assets owned, it will be eligible to file under its previous
designation as an operating company and report as an operating
company and will take steps to accomplish this result.
Any shareholder who is interested in learning
more about our medical instrumentation and biotechnology operations
should visit our website at www.daxor.com or contact our investor
relations representative Bret Shapiro of CORE IR at 516-222-2560
for more detailed information. We periodically issue press releases
regarding research reports and acquisitions of our BVA technology
by customers.
For more information, please visit our website
www.daxor.com. Sign up to receive news on Daxor’s innovative
technology and investor announcements at
www.daxor.com/investors.
Cordially Yours,
Michael FeldschuhCEO and President
About Daxor Corporation
Daxor Corporation (Nasdaq: DXR), is the global
leader in blood volume measurement technology focused on blood
volume testing innovation. We developed and market the BVA-100®
(Blood Volume Analyzer), the only diagnostic blood test cleared by
the FDA to provide safe, accurate, objective quantification of
blood volume status and composition compared to patient-specific
norms. Over 65,000+ tests have been performed at leading hospital
centers across the U.S., enhancing hospital performance metrics in
a broad range of surgical and medical conditions, including
significantly reducing mortality and readmissions in heart failure
and critical care. Daxor has several ongoing trials in the areas of
heart failure treatment with support from the NIH and is under
contract developing analyzers to improve combat casualty care with
the U.S. Department of Defense. Daxor's mission is to advance
healthcare by enabling optimal fluid management with blood volume
analysis. Daxor’s vision is optimal blood volume for all. For more
information, please visit our website at Daxor.com. Sign up to
receive news on Daxor’s innovative technology HERE.
Forward-Looking Statements
Certain statements in this release may include
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, including without
limitation, statements regarding the impact of hiring sales staff
and expansion of our distribution channels. Forward-looking
statements are predictions, projections and other statements about
future events that are based on current expectations and
assumptions and, as a result, are subject to risks and
uncertainties. Many factors could cause actual future events to
differ materially from the forward-looking statements in this
release, including, without limitation, those risk associated with
our post-market clinical data collection activities, benefits of
our products to patients, our expectations with respect to product
development and commercialization efforts, our ability to increase
market and physician acceptance of our products, potentially
competitive product offerings, intellectual property protection,
FDA regulatory actions, our ability to integrate acquired
businesses, our expectations regarding anticipated synergies with
and benefits from acquired businesses, and additional other risks
and uncertainties described in our filings with the SEC.
Forward-looking statements speak only as of the date when made.
Daxor does not assume any obligation to publicly update or revise
any forward-looking statements, whether as a result of new
information, future events or otherwise.
Investor Relations Contact:Bret ShapiroSr.
Managing Partner, CORE IR1-516-222-2560brets@coreir.com
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