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DAXOR CORP

DAXOR CORP Q2 FY2022 earnings call

August 26, 2022 · fiscal period ended 2022-06

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Summary

Generated 2022-08-26

Management highlights

• Clinical Achievements: Blood volume analysis was selected by the NIH for a COVID-19 Long Hauler study, and data from Baptist Heart Health System and Duke Heart were presented at medical conferences validating benefits in heart failure. • Product Development: Successfully completed Army Department of Defense contract for a portable combat care device, NIH-funded I-Corps program, and Phase II Cooperative Research Agreement for a non-nuclear tracer. Began submitting data to the FDA for clearance of the next generation blood volume analyzer, with anticipation of full submission in Q4 2022 and approval in early 2023. • Partnerships: Partnered with MedAxiom, an industry leader in cardiovascular care consulting, to raise the company's profile and drive sales. • Clinical Trials: Active in ongoing clinical trials funded by the DoD and NIH, including two NIH multicenter prospective heart failure trials and a prospective sepsis/COVID study. • Intellectual Property: Awarded a patent in January 2022 for clinical decision support software, with several pending patents and a growing patent portfolio.

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Segment performance

Daxor's blood volume diagnostic operating division saw a 92.6% increase in unaudited revenues for the period ended June 30, 2022 compared to the same period in the prior year. Revenue growth was driven by a combination of sales and leasing of capital equipment, orders for single use disposable blood volume diagnostic kits (which rose 49.4% in the first half of 2022 compared to the first half of 2021), U.S. Department of Defense orders, and orders from third-party companies for blood volume analysis and research on pharmaceutical products. The blood volume diagnostic operating division contributed significantly to the overall revenue, with key drivers including growth in kit sales and diverse revenue sources like research agreements and grants.

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Guidance

• Anticipates full submission of the next generation blood volume analyzer to the FDA in Q4 2022 and approval in early 2023. • Plans to transition to a software as a service (SaaS) model for the next generation devices, aiming to provide a recurring revenue stream and swap out current devices for new systems. • Focuses on integrating blood volume analysis into the standard care pathway at hospital systems through partnerships and clinical education to drive adoption.

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Risks

• Supply Chain and Inflation: While Daxor manufactures in the U.S. and has avoided major supply chain issues, it has faced inflationary costs related to staffing. • Regulatory: Risks associated with the FDA approval process for the next generation blood volume analyzer. • Market: Economic conditions may impact hospital spending on medical equipment, affecting sales and adoption of products.

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Q&A highlights

Q: What makes the new BVA different from the original device?

A: The new BVA is portable, provides results in 15 minutes (vs. 60-90 minutes for the current device), features a six by eight inch touchscreen, and uses a non-isotopic fluorescent marker. It is designed for point-of-care use and is much faster and more user-friendly than the original device.

Q: Have you seen suppression of sales due to the impending new device?

A: No, existing accounts are experiencing growth in utilization. The sales model for the new device will be a SaaS model, and efforts are underway to swap out current devices for new systems with credit or trade-in options.

Q: Are there international sales?

A: Daxor achieved ISO 13485 certification and is working towards a CE mark for international sales. Currently focused on the U.S. market first but plans to expand internationally with the new generation device.

Q: Issues with supply chain and inflation?

A: Daxor manufactures in the U.S. and has avoided significant supply chain problems, but has faced inflationary costs related to staffing, such as rising salaries and benefits for technical and software development talent.

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Transcript

August 26, 2022

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