5/22/2023

speaker
Operator
Conference Operator

Good afternoon and thank you for joining us today.

speaker
Mike
Investor Relations, Nanox Imaging Limited

Earlier today, Nanox Imaging Limited released financial results for the quarter ended March 31st, 2023. The release is currently available on the investor section of the company's website. Perez Meltzer, Chief Executive Officer, and Ron Daniel, Chief Financial Officer, will host this morning's call. Before we get started, I would like to remind everyone that management will be making statements during this call that include forward-looking statements regarding the company's financial results, research and development, manufacturing and commercialization activities, regulatory process operations and other matters. These statements are subject to risks, uncertainties and assumptions that are based on management's current expectations as of today and may not be updated in the future. Therefore, these statements should not be relied upon as representing the company's views as of any subsequent date. Factors that may cause such a difference include, but are not limited to, those described in the company's filings with the Securities and Exchange Commission. We will also refer to certain non-GAAP financial measures to provide additional information to investors. A reconciliation of the non-GAAP financial measures to the nearest GAAP financial measure is provided in our press release. The non-GAAP financial measures include non-GAAP net loss attributable to ordinary shares, non-GAAP cost of revenue, non-GAAP gross profit, non-GAAP gross profit margin, non-GAAP research and development expenses, non-GAAP sales and marketing expenses, non-GAAP general and administrative expenses, and non-GAAP gross loss per share. With that, I'd now like to turn the call over to Erez Meltzer.

speaker
Erez Meltzer
Chief Executive Officer

Thank you, Mike, and thank you all for joining the call today. I will provide an overview of our recent operational accomplishments before handling the call over to Ren to review our financial results, and then we will close as usual with a question and answer session. With that, I'll get right into it, and I'll start with the news. that I'm sure is at the top of everyone's mind, which is the recent FDA clearance for Nano-X Arc system. As a reminder, on April 28, 2023, we received a 510 clearance from the FDA to market the Nano-X Arc, including the Nano-X Cloud. It's a company cloud-based infrastructure. The approved device is intended to be used in professional healthcare facilities or radiological environments such as hospitals, clinics, imaging centers, and other medical practices by trained radiographers, radiologists, and physicians. Representing a major advancement in the X-ray tube technology, the NanoARC is a multi-source 3D tomosynthesis system that utilizes novel cold cathode X-ray tubes which the company intends to offer using an innovative paper scan business model. We believe that the NANUX ART has the potential to increase availability to medical imaging globally once approved by local regulatory authorities and deployed in scale. We intend to deploy this version of the NANUX ART that was cleared by the FDA which has the power level necessary to scan the MSK system. We believe the FDA clearance will assist in our efforts to gain regulatory clearance in certain other jurisdictions, including in other countries that are FDA clearance-based markets. Following this clearance, NANUCS will continue to work with the FDA to pursue additional regulatory clearances and intends to expand clinical indications. Other applications may be available in other markets per local regulatory approvals. With FDA clearance secured, we are in the process of setting up a U.S. demo center located in Fort Lauderdale, Florida, which will be used for commercial purposes. We are currently working to secure an import license and expect to ship the NANUC's ARC units later this quarter. Additionally, we continue pursuing the European Union CMARC and continue our work with our notified body, BSI, to whom we've already submitted the contract package. While it is gratifying to see the commercial and regulatory process of recent months, at the same time, we are collecting additional data supporting the use of the Nano-XR system. Under the Helsinki permits, which we have previously disclosed, we started to collect clinical sample images of multiple human body anatomies with Nano-XR system that was deployed in the Shamir Hospital in Israel. Additionally, we recently passed independent evaluation of the device by the Israeli Ministry of Health, which facilitates further clinical trials in Israel utilizing the Nano-X Arc. We are planning to conduct a clinical trial in Israel to evaluate the diagnostic potential of the Nano-X Arc for chest and lung diseases on patients with these pathologies. The trial is expected to be executed in collaboration with a local hospital in Israel and is expected to begin in the second half of 2023. Turning to commercial deployment activities, NANOS has entered into a three-year distribution agreement with a local partner in Morocco, Vitaltech SARL. Under the distribution agreement, Vitaltech will purchase, deploy, and operate an estimated 270 NANOS ARC units over three years for clinical use. The execution is subject to acceptance tests of the first units and regulatory clearances. We have already received an import license. We have sent the first unit, and our deployment team is on the ground as we speak. Morocco is enhancing our footprint in Africa in addition to work we are doing to deploy in Nigeria and Ghana, which we have discussed on previous calls. I will now take a few minutes to introduce and discuss a new commercial partnership which extends the reach of Nano-X AI. During this quarter, we entered the global partnership with Blackford Analytics to market our Nano-X Arc product. Blackford Analytics is a global imaging AI solution provider, and this partnership is intended to broaden the reach of Nano-X AI cardiac and bone solutions by presenting the NanoX AI algorithms on Blackford's platform, which offers a wide portfolio of imaging AI software and services. We believe partnering with Blackford is an important step in expanding the reach of NanoX AI, Health OST, and Health CCS&G solutions into radiology department globally, including the US and Europe, NanoXAI solution may also benefit downstream physicians in cardiology and endocrinology by enhancing their abilities and help detect subclinical levels of osteoporosis and cardiovascular disease. Moreover, we have already completed the installation of our application in four out of five NHS clinical institutions in the UK, and our system has been installed in 10 clinical institutions in the U.S. for the purpose of initial clinical pilot. Turning to technology and manufacturing, and as previously mentioned in our previous learning calls, since the beginning of this year, we have been improving our production line capabilities and establishing an operational assembly line to enable the expected ramp-up in the production and preparation for the shipments of the Nano-X Arc system later this year. With deployment as a key focus, I am pleased to report that the production line at Begesh is now fully operational. Furthermore, I am happy to share that Nano-X Korea received the ISO 123485 certificate on April 5, 2023. The scope of this certificate obtained by Nanox Korea covers design, development, manufacturing, and sales of X-ray tubes for medical use. Before turning the call over to Ron, I'd like to touch on the Nanox AI and Telluridology business segment, which continue to generate revenue. This business has generated top-line revenues of $2.4 million compared to $2.1 million revenues in Q4 2022. almost a quarter-to-quarter increase of 15%. Ron will review the financials in more detail, but as I've stated before, these businesses are attracting customers, thereby demonstrating the utility of these services to healthcare systems, and we are confident they will add significant value to the fully integrated NanoXARC system upon deployment. Our work is not done, but we are now at an inflection point in our company's history and are now looking ahead to deploying the Nano-X Arc at a large scale globally. With that, I'd like to turn the call over to Rand Daniel, Chief Financial Officer, to review our financial results.

Disclaimer

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