Daxor Corporation Q4 FY2022 earnings call

• The company is on the brink of launching its next-generation blood volume analyzer, with a focus on commercializing existing products, furthering clinical evidence, and innovating next-gen analyzers. • Completed an Army contract in 2022 to create a working prototype suitable for FDA submission. • Had a pre-submission meeting with the FDA in Q3 2022, and anticipates submitting the 510(k) application within 90 days, aiming for mid-year 2023 approval for commercial launch. • Commercial teams are growing, with 18 new hospital accounts opened in 2022 and 5 more pending. • Participated in conferences and partnerships with organizations like the Heart Failure Society of America and MedAxiom Group to raise clinical awareness. • Raised prices of single use injection kits from $225 in 2020 to $355 in 2022, with a planned further increase to $385 by end of Q1 2023. • Ongoing clinical research includes trials with the NIH, VA center, Geisinger Medical Center, and a COVID multi-center trial.

For the year ended December 31st, 2022, Daxor's net assets increased 37% to $28,969,469 or $6.75 per share. The value of the operating division increased $9.5 million to $26 million from $16.5 million in 2021. Net dividend income was $223,916, net realized gains on investment activity were $2,736,375, and there was a net decrease in unrealized depreciation of investment options securities borrowed. There was a net realized loss of $3,264,419 from the operating division related to R&D and sales overhead investments.

• Anticipates submitting the 510(k) application for the next-generation analyzer within the next 45-60 days, with a 90-day FDA review period aiming for mid-year 2023 commercial launch. • Focus on increasing utilization at existing accounts and opening new accounts. • Plan to expand the sales force as productivity per rep increases with the new technology.

• FDA regulations restrict marketing unapproved devices, limiting communication with clients about the next-generation analyzer. • Uncertainty around SEC reporting status transition from 40 ACT to 34 ACT, with no clear statutory guidance and potential delays. • Market adoption challenges, including competing priorities for hospital capital spending and the need to overcome clinical and administrative resistance to new technology.

Q: What is the timeline for submitting the 510(k) application for the new analyzer?

A: Daxor hopes to complete the 510(k) application package by the end of the year, submit it within the next 45-60 days, with a 90-day FDA review period aiming for Q3 2023 commercial launch.

Q: How many new accounts were opened in 2022?

A: 18 new hospital accounts were opened in 2022, with 5 more pending.

Q: Is the current sales force sufficient for the sales plan?

A: The current sales force is focused on increasing productivity per rep, and as productivity increases with the new technology, the sales force will be expanded.

Q: How have price increases affected sales?

A: Price increases from $225 to $355 in 2022 saw substantial uptake, and a further increase to $385 is planned with good customer reception.