NANO-X IMAGING LTD

Ladies and gentlemen, thank you for standing by and welcome to the NANDOX Imaging Q4 and full year 2021 earnings conference call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you need to press star 1 on your telephone. If you require any further assistance, please press star 0. I would now like to turn the call over to Mike Cavanaugh, Investor Relations. You may begin.

Thank you. Good afternoon and thank you for joining us today. Earlier today, Nanox Imaging Limited released financial results for the full year and quarter ended December 31, 2021. The release is currently available on the investor section of the company's website. Eris Meltzer, Chief Executive Officer, and Ron Daniel, Chief Financial Officer, will host this afternoon'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, the impact of COVID-19 on its business, 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 on 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 to GAAP measures is provided with our press release, with the primary differences being stock-based compensation and class action-related expenses. I'd now like to turn the call over to Nanox's CEO, Erez Meltzer.

Thank you, Mike, and thank you all for joining the call today. As most of you know, I assumed my role as CEO on January 1st. It's what I consider to be a pivotal time in Nanox's development trajectory. We have made several advancements since our last earnings call. I look forward to sharing some exciting developments with you today. I will give an overview of our achievements since our last earnings call, as well as share our outlook on the year ahead. Before turning the call over to Rand Daniel, our CFO, to review our financial results, we will then open the call up to questions. I would like to start by providing an update on our regulatory and commercialization progress as it pertains to our conversations with the FDA around the NanoX ARC system. We announced last quarter that we would be reviewing feedback from the FDA pertaining to our first submission relating to our multi-source NanoX ARC. In January of this year, after careful review of the FDA's feedback on our first submission, we filed a pre-submission towards an additional 5.0K application for the second version of NanoXARC, our high-performance multi-store system via the agency's Q-Submission Program. We are in continuous communication with the FDA and believe that this route will be the most expeditious pathway to further FDA feedback, which will be followed by formal submission. We expect that the Q submission will lead to thoughtful improvements to the NanoPSAR, and that if cleared by the FDA, the system will be suitable for development later this year. We have made considerable headway towards commercialization over the past year, and our team remains committed to deployment of the NanoX Arc units and is focused on execution in the months ahead. We are pleased to report that we have begun generating revenues, in large part due to our three previously announced strategic transactions, the combination of which create a path to streamlined commercialization. Combined with our patented x-ray technology, the acquisitions of Zebra Medical Vision, now Nanox AI, a deep learning machine analytics company, MDW LLC, a decentralized marketplace connecting imaging facilities with radiologists, and USA Rod Holdings Inc., a leading provider of teleradiology services, we are well on the path to provide more accessible and affordable health care We believe that integrating AI-powered imaging analysis and global teleradiology solution with our nanospark technology takes us one step closer to creating a global streamlined medical imaging continuum from image capture through analysis to intervention by trained radiologists. Under one umbrella, we now have the potential capabilities to significantly improve access, reduce cost, and enhance efficiency, which could increase the chances of early detection as well as patient access to care in a meaningful manner. We are pleased with our ongoing integration of the companies we acquired at the end of 2021 and have taken a number of cost reduction measures in order to streamline operations and benefit from synergies. As these companies begin to contribute to NANUC's top line, we believe they will enhance the services provided by NANUC's system. We intend to explore collaborations for additional solutions and wider product offerings. In December 2021, we were excited to announce that USA-RUS was rectified with the Joint Commission's Gold Seal of Approval, which reflects the high standards that USA-RUS has maintained since its inception. By meeting the quality standards of most widely recognized medical credentialing program in the country. Furthermore, I'm pleased to share that we have strengthened the leadership team of Nanos AI. Effective March 1st, 2022, we appointed Peter Benalazar as General Manager of Nanos AI. Mr. Benalazar brings 20 years of strategic and commercial expertise in the healthcare industry, and is uniquely equipped to help drive the integration of Nano's collective roadmap and vision. Having served on the board of Zebra Medical Vision since its inception, Mr. Benalazar understands the joint vision and mission of the merged company. Mr. Benalazar was one of the architects of Zebra Clalit Health Services, Clalit is the largest health maintenance organization in Israel and is the second largest HMO in the world, strategic collaboration. Mr. Ben-Elzar previously also served as CEO of More Research Application, a technology transfer organization of Clalit. We are confident that he has the vision and the expertise to help drive Nanox AI into the global market. I would like to also highlight a few other achievements since our last report. In January 2022, we announced that the American Medical Association issued a new category three current procedural terminology, CPT code, for quantitative CT tissue categorizations, enabling potentially broader use of NANOX AI's health cardiac calcium scoring, our FDA cleared, AI-enabled cardiac imaging solution that detects coronary artery calcium, CHP, for patients in the U.S. The code will become effective on July 1, 2022. We consider this important validation of our technology and a key step towards advancing detection and treatment of cardiovascular diseases. We believe focusing on reimbursement of our technology will result in further interest and demand for the nanosystem. I would like to announce another agreement that has recently been signed for Nanos AI. Earlier this month, Nanos AI entered into an agreement with a large integrated healthcare organization based in the U.S. that provides care and coverage with the potential to create a more equitable model of health and wellness. Under this agreement, the healthcare organization will deploy the NanoxAI-enabled software designed to promote increased early detection of risks for cardiovascular diseases and osteoporosis in chest, computerized tomography, CT scans. We believe that the partnership between NanoxAI and the integrated healthcare organization will enable physicians to efficiently identify many previously under-detected patients who may be at risk for cardiovascular diseases and or osteoporosis, which could improve individual patient lives as well as having broader implications for population health and management of chronic disease. Implementation will begin immediately and the tools are expected to be rolled out to hospitals within the organization's network of hospitals in the coming months. As for NanoxART, as previously reported, we have signed 11 MSAS agreements for global deployment of 6,500 units of NanoxART multi-store system. These agreements are for different territories, including Africa, Central America, and Europe. and the system will be deployed in such markets according to the local regulations subject to requisites clearance in each market. Since the beginning of the year, we have made significant progress in materializing a revision both within the company and outside of it. We've been focused mainly on establishing our production capabilities towards the deployment of PhenomXR system later this year establishing new partnerships, and enhancing our regulatory path. Our assembly efforts are primarily conducted at our Tagesh facility in Israel. Since the beginning of the year, we have been improving our production line capabilities and establishing an operational assembly line to enable the expected rent up in production and preparation for shipments of the non-exotic system later this year. Operationally, our technology transfer to NanoT's wholly-owned Korean subsidiary to enable production of the silicon MEMS chip has been completed. This is an integral piece of the NanoT's digital X-ray source, and with the launch of the production at the facility now underway, we anticipate being in full production by mid-year 2022. The key initiative is especially important given the current supply chain shortages for chips worldwide. We believe this will help to secure a stable supply of chips that we need for the production of the non-XR while ensuring the quality of our chips for us and the healthcare professionals who will use our non-XR systems. With that, I would like to turn the call over to Rand Dario, Chief Financial Officer.