Release Date: August 20, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Nano X Imaging Ltd (NNOX, Financial) submitted a new 510(k) submission to the FDA to expand the indications for the Nanox.ARC system, which could significantly broaden its use.
- The company is in advanced stages to secure the CE mark for the EU region, which would allow for broader deployment in Europe.
- Commercial deployments are accelerating, with dozens of units in various stages of shipment and deployment across multiple states in the US.
- The Nanox.AI cardiac solution, HealthCCSng, has shown promising results in multiple scientific studies and real-world implementations.
- The company is developing a new system, Nanox.ARC X, which will have a smaller footprint, easier deployment, and enhanced imaging capabilities.
Negative Points
- Nano X Imaging Ltd (NNOX) reported a GAAP net loss of $13.6 million for Q2 2024, although this was an improvement from the previous year.
- The company experienced a gross loss of $2.9 million on a GAAP basis, compared to a gross loss of $1.7 million in the same period last year.
- Revenue from the sales and deployment of imaging systems was only $68,000, with a gross loss of $1.3 million.
- The company is still awaiting regulatory approvals in several states, which could delay further deployments.
- There is uncertainty regarding the timeline for FDA clearance of the new 510(k) submission, which could impact future commercial efforts.
Q & A Highlights
Q: Could you expand upon your backlog regarding imaging sales and leads? Where are these units mostly located, and what is the expected timeline for placements and training?
A: We have more than tripled our backlog to over 50 favorable prospects and 44 leads, primarily in the US. We have several dozen units already deployed, with some awaiting state approvals. We expect to meet our deployment targets by the end of the year.
Q: Can you discuss the new 510(k) indications for general tomosynthesis and the associated reimbursement codes?
A: The reimbursement is based on the tomo CPT code 76100. We have received positive indications from insurers, aligning with our profitability model. The new 510(k) submission includes whole-body imaging, which will enhance our system's utility once cleared.
Q: Could you provide more details about the ARC X platform and its differences from the current platform?
A: The Nanox.ARC X will have a smaller footprint, easier deployment, and new image enhancement options. It will be marketed alongside the current system, expanding our product offering. We will provide more details in the next quarter.
Q: What is the expected review timeline for the 510(k) application for general use and chest indications?
A: While we hope for a faster review process than previous submissions, we cannot provide a specific timeline. We will announce the clearance once it is received.
Q: Have you received any feedback from the three US medical imaging chains where Nanox.ARC systems are installed?
A: We have received positive feedback on clinical use, maintenance, and installation processes. This feedback has encouraged us to accelerate deployment and improve our service and products.
Q: Should we expect any seasonality in the US market for Q3 relative to Q2?
A: We do not expect any seasonality effects, especially as we are ramping up our installed base. We anticipate better results in the coming quarters.
Q: Can you walk us through your current manufacturing capabilities and contract initiatives?
A: We have secured chip supplies and multiple tube suppliers. Our assembly site in Israel has increased capacity, and we are prepared for the next few quarters. We are also planning for further ramp-up in 2025.
Q: How large is your US sales force, and are there plans to expand the team?
A: Currently, we have around 15 people, including independent agents. We plan to grow this number to 30-40 by 2025.
Q: What is your commercialization plan in Europe and other geographies following CE mark approval?
A: We will leverage existing agreements and distributors in countries like Mexico, Spain, Australia, and New Zealand. We are targeting medium to large medical centers and will use distributors for deployment, except in the US, Israel, and the UK, where we will have our own teams.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
