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NANO-X IMAGING LTD
5/11/2021
This time, all participants are in the listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Glenn Garmont of Investor Relations.
Thank you, Joe, and thanks to everybody for joining the Nano-X Imaging First Quarter 2021 Conference Call. On today's call, we will hear from Ron Polyakin, Chairman of the Board of Directors and Chief Executive Officer, and Itzhak Mayan, Chief Financial Officer. Before we begin, I'd like to remind everyone that management's remarks today may contain forward-looking statements regarding the company's financial results, research and development, manufacturing and commercialization activities, regulatory process, operations, the impact of COVID-19 on its business, and other matters. These statements are subject to risks, uncertainties, and assumptions and 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 SEC. We will also refer to certain non-GAAP financial measures to provide additional information to investors. A reconciliation of non-GAAP to GAAP measures is provided in our press release, with the primary differences being stock-based compensation and class action-related expenses. With that, I would like to turn the call over to Nanox's Chairman and Chief Executive Officer, Ron Polyakin. Ron?
Thank you, Glenn, and thanks to everyone joining our first quarter update call. Also joining me on the call this morning is Yitzhak Maayan, our CFO. I would like to start with the FDA 510K clearance of Nanox CART X-ray system. The key highlight since our last quarterly update has been the FDA clearance for our single source system, which we now refer to by its cleared name, the Nanox CART X-ray system. This 510K clearance represents a significant milestone, for our company. It is the result of nine years of R&D and a very meaningful leap forward in X-ray technology. We believe that this clearance supports a similar regulatory pathway for the multi-source system. This clearance is an important stepping stone towards our designated commercial multi-source system, the NanoX Arc, that leverages our unique main chip low-voltage nanoscale cold cathode X-ray source technology. It is smaller and cheaper to manufacture the legacy hot filament technology that requires special cooling and rotating mechanics and we believe can replace analog X-ray technology that has been used for over 120 years. As we demonstrated live at RSNA, the NanoSarc can produce high-resolution clinical quality imaging in both 2D and 3D across a range of imaging procedure. We believe the results is a simpler, more cost effective machine with a smaller footprint. Moving now to the supply chain and manufacturing ramp-up update. So our supply chain and manufacturing ramp-up We continue to make important progress building our global supply chain, including scaling up our semiconductor fabrication plant in South Korea. The fab is currently in construction and will be built next to the SK Hynix Semiconductor Cluster in South Korea, the world's largest semiconductor center. The fab site is 12,000 square meters, including 1,200 square meters MEMS Cleanroom. This overall project cost is estimated at $45 million and the plant is expected to be operational mid-next year. In the meantime, we are currently operating out of a temporary manufacturing fab facility in South Korea for MEMS production, which will start contributing to our end-to-end chip production process during the second half of this year. The technology transfer from Japan to our South Korean subsidiary is progressing as planned. At this point, I would like to provide an update on the development of our multi-source NanoSARC, which will be our actual commercial device. Recently, we have experienced delays which were compounded by the COVID-19 pandemic with the first manufacturer of our second generation high-power ceramic tube. We are currently working with two alternative tube suppliers, for the multisource system. As a result, while we do not expect to meet our previously announced milestone of shipment of 1,000 units multisource Nano-X by the first quarter of 2022, we believe that we will be able to gain ground during the year to reach the shipment milestone of 1,000 Nano-X units during 2022 and possibly more if the multisource Nano-X arc is cleared by the FDA and authorized by other similar regulatory agencies. NanoX continues to expect submission of a 510K pre-market notification to the FDA with the multi-source NanoX Arc and the NanoX Cloud during 2021 and deployment of an initial wave of approximately 15,000 NanoX Arc units by the end of 2024. Moving to the commercial update. At this point, I would like to provide an update on our commercial activities. Recall that we have a unique business model, which we call MSAS, Medical Screening as a Service, which employs a paper scan approach. This is a key differentiator for us. It avoids the significant upfront investment associated with traditional X-ray technology. making the machine more affordable for healthcare facilities of all sizes. We believe this model has been key to our early success in entering into commercial agreements. Recall that we currently have contracts in place for the deployment of 5,150 nanoSARCs units with nine service providers in 13 countries. In addition, We have collaborations with USA RAD and SK Telecom for the deployment of an additional 5,500 units in the U.S., South Korea, and Vietnam. And following our live demo at RSNA, we've been experiencing increasing interest from service providers across many countries, resulting in a growing pipeline of potential opportunities to enter into additional MSAS agreements. The NANOX Arc is just one element of our potential value proposition. We believe that the medical imaging should migrate to a universally connected global cloud service with superior accessibility to medical data and its analysis for the benefit of preventive healthcare. Our vision is to provide a worldwide end-to-end medical imaging solution including remote services such as image repository, radiologist matching, online and offline diagnostic review and annotation, connectivity to medical imaging AI systems, and billing and reporting. As we move forward towards commercialization, we're continuously seeking opportunities to expand our capabilities through potential partnerships and acquisitions. Moving on to team additions. Before turning the call over to Yitzhak to review the financials, I'm turning now to our team. I'm excited to say that we've made a number of significant additions to our leadership, most recently with the addition of Moshe Stengel, our Chief Business Officer. Moshe has substantial experience in global and medical business, development, and sales executive. We also announced the additions of Jim Dera, COO, Ophir Koren, CTO, and Tamar Aaron Cohen, CMO. All of these individuals bring substantial experience to their roles. I believe this is an indication that we are building out a world-class team that best positioned us for long-term success. At this point, I will turn the call over to Yitzhak for a review of our financials. Yitzhak, please.
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