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Nano-X Imaging (NNOX) - 2022 Q1 - Earnings Call Transcript
2022-05-19 14:49
Nano-X Imaging Ltd (NASDAQ:NNOX) Q1 2022 Earnings Conference Call May 19, 2022 8:30 AM ET Company Participants Mike Cavanaugh - IR, ICR Westwicke Erez Meltzer - Chief Executive Officer Ran Daniel - Chief Financial Officer Conference Call Participants Suraj Kalia - Oppenheimer Jeffrey Cohen - Ladenbrug Thalmann Rahul Rakhit - LifeSci Capital Operator Good day, and thank you for standing by. Welcome to the NANO-X IMAGING First Quarter 2022 Earnings Conference Call. At this time, all participants are in a list ...
Nano-X Imaging (NNOX) - 2021 Q4 - Annual Report
2022-05-02 12:14
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 19 ...
Nano-X Imaging (NNOX) - 2021 Q4 - Earnings Call Transcript
2022-03-31 15:57
Financial Data and Key Metrics Changes - The company reported a GAAP net loss of $61 million for the full year 2021, compared to a net loss of $43 million in 2020 [19] - For Q4 2021, the GAAP net loss was $22 million, compared to a net loss of $19 million for the same period in 2020 [19] - Revenue for the year ended December 31, 2021, was $1.3 million, with a gross loss of $1.5 million [19][20] - Non-GAAP net loss for the full year 2021 was $39.2 million, compared to $18.9 million in 2020 [25] Business Line Data and Key Metrics Changes - Revenue from radiology services for Q4 2021 was $1 million, with a gross profit of $0.0 million on a GAAP basis and a gross profit of $0.4 million on a non-GAAP basis, representing a gross profit margin of approximately 40% [20] - Revenue from licensing of AI applications for Q4 2021 was $0.3 million, with a gross loss of $1.5 million on a GAAP basis [21] Market Data and Key Metrics Changes - The company signed 11 MSaaS agreements for the global deployment of 6,500 units of the Nanox.ARC multi-source system across various territories, including Africa, Central America, and Europe [15] Company Strategy and Development Direction - The company aims to streamline commercialization through strategic acquisitions, including Zebra Medical Vision (now Nanox.AI), USARAD Holdings, and MDW LLC, to enhance healthcare access and affordability [9][10] - The leadership team of Nanox.AI has been strengthened with the appointment of Pini Ben Elazar as General Manager [12] - The company is focused on establishing production capabilities for the Nanox.ARC system and enhancing regulatory pathways [16][17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about ongoing communication with the FDA regarding the Nanox.ARC system and expects thoughtful improvements based on FDA feedback [7][8] - The company anticipates being in full production of the Nanox.ARC system by mid-2022, which is crucial given current global chip supply shortages [17] Other Important Information - As of December 31, 2021, the company had cash equivalents and marketable securities of $156.6 million and $3.8 million in loans from banks [27] - The company ended the year with approximately 51.8 million shares outstanding, an increase from 46.1 million shares at the end of 2020, primarily due to acquisitions [28] Q&A Session Summary Question: What is the update expectation on approval or clearance for the multisource? - Management indicated that they do not expect the FDA response to take the full 75 days and are hopeful for a quicker response based on ongoing discussions [35][36] Question: What are the annualized revenue run rates and growth rates for Nanox.AI and USARAD segments for FY 2022? - Expected annual revenue for USARAD is around $8 million to $9 million, while for the AI segment, it is projected to be $3 million to $4 million [41] Question: What was the litigation expense in the fourth quarter? - The litigation expense related to the SEC probe and class action was $455,000 for the quarter [47] Question: Can you provide a sense of the size of the integrated healthcare organization? - The organization is among the top 25 in the U.S., indicating a significant size and influence in the healthcare sector [52] Question: What is the status of the production and delivery commitments for 2022? - Management confirmed that they have ordered necessary components for assembly and expect to produce hundreds of machines quarterly [48]
Nano-X Imaging (NNOX) - 2022 Q1 - Quarterly Report
2022-03-31 11:59
Revenue Performance - Revenue for Q4 2021 was $1.3 million, compared to $0 for Q4 2020, with a non-GAAP gross profit of $0.2 million[4] - The company reported a revenue of $1.304 million for the year ended December 31, 2021, compared to $0 for the previous two years[35] Net Loss and Expenses - The company reported a net loss of $22.0 million for Q4 2021, an increase from a net loss of $19.0 million in Q4 2020, primarily due to merger-related expenses[5] - The non-GAAP net loss applicable to ordinary shares for Q4 2021 was $15.0 million, compared to $8.4 million in Q4 2020[9] - The company reported a net loss of $61.798 million for 2021, compared to a net loss of $43.815 million in 2020, which is a 41% increase[35] - The non-GAAP net loss attributable to ordinary shares for 2021 was $39.124 million, compared to $18.902 million in 2020, reflecting a 106% increase[37] Research and Development - Research and development expenses for Q4 2021 were $6.4 million, up from $3.0 million in Q4 2020, driven by the merger and increased R&D headcount[6] - Research and development expenses rose to $17.122 million in 2021, up from $9.210 million in 2020, indicating a 85% increase[35] General and Administrative Expenses - General and administrative expenses increased to $10.9 million in Q4 2021 from $8.1 million in Q4 2020, largely due to merger-related costs and legal fees[8] Cash and Assets - The company had $88.7 million in cash and cash equivalents as of December 31, 2021, down from $213.5 million a year earlier[12] - Cash and cash equivalents decreased significantly to $66.645 million in 2021 from $213.468 million in 2020, a decline of 69%[33] - The company's total assets increased to $363.170 million in 2021 from $236.149 million in 2020, representing a growth of 54%[33] Liabilities - Total current assets were $94.9 million and total current liabilities were $52.8 million, resulting in working capital of $42.1 million[12] - The total liabilities rose to $71.022 million in 2021, compared to $5.403 million in 2020, marking a substantial increase[33] Shareholder Information - The weighted average number of ordinary shares increased to 48.216 million in 2021 from 35.654 million in 2020, a rise of 35%[37] Future Outlook - The American Medical Association issued a new CPT code for quantitative CT tissue characterization, effective July 2022, which may enhance future revenue opportunities[3] - The company is focused on the development and commercialization of its X-ray source technology and the Nanox.ARC, with expectations for future growth and market acceptance[25]
Nano-X Imaging (NNOX) - 2021 Q3 - Earnings Call Transcript
2021-11-17 16:45
Nano-X Imaging Ltd. (NASDAQ:NNOX) Q3 2021 Earnings Conference Call November 17, 2021 ET Company Participants Ran Poliakine ??? Chairman of the Board and Chief Executive Officer Mike Cavanaugh ??? Investor Relations Erez Meltzer ??? Executive Board Member and incoming Chief Executive Officer Ran Daniel ??? Chief Financial Officer Conference Call Participants Jeffrey Cohen ??? Ladenburg Thalmann Suraj Kalia ??? Oppenheimer Ravi Misra ??? Berenberg Capital Rahul Rakhit ??? LifeSci Capital Operator Thank you fo ...
Nano-X Imaging (NNOX) - 2021 Q3 - Quarterly Report
2021-09-30 20:30
Exhibit 99.1 NANO-X IMAGING LTD The Communications Center Neve Ilan, Israel 9085000 Telephone: 972 2 5360360 NOTICE OF ANNUAL GENERAL MEETING OF SHAREHOLDERS To Be Held on November 4, 2021 To our Shareholders: You are invited to attend the Annual Meeting of Shareholders of Nano-X Imaging Ltd ("we" or the "Company") to be held at the Company's offices at The Communications Center, Neve Ilan, Israel on November 4, 2021 at 15:00 Israeli time (9:00 am EST), and thereafter as it may be adjourned from time to tim ...
Nano-X Imaging (NNOX) - 2021 Q2 - Earnings Call Transcript
2021-08-10 18:08
Nano-X Imaging Ltd (NASDAQ:NNOX) Q2 2021 Results Conference Call August 10, 2021 8:30 AM ET Company Participants Bob Yedid - IR Ran Poliakine - CEO Itzhak Maayan - CFO Conference Call Participants Steve Halper - Cantor Jeffrey Cohen - Ladenburg Suraj Kalia - Oppenheimer & Company Ravi Misra - Berenberg Rahul Rakhit - LifeSci Capital Operator Thank you for standing by. This is the conference operator. Welcome to the Nano-X Imaging Second Quarter 2021 Earnings Call. As a reminder, all participants are in a li ...
Nano-X Imaging (NNOX) - 2021 Q1 - Earnings Call Transcript
2021-05-11 17:49
Financial Data and Key Metrics Changes - The company reported a GAAP net loss applicable to ordinary shares of $12.7 million for Q1 2021, compared to a net loss of $7.4 million for Q1 2020, indicating a significant increase in losses [15] - Non-GAAP net loss applicable to ordinary shares for Q1 2021 was $7.1 million, up from a non-GAAP net loss of $2.6 million in the same period in 2020 [16] - As of March 31, 2021, the company had approximately 47.6 million shares outstanding and cash and cash equivalents of approximately $219.3 million, with no debt [19] Business Line Data and Key Metrics Changes - The company has contracts in place for the deployment of 5,150 Nanox.ARC units with 9 service providers in 13 countries, with additional collaborations for 5,500 units in the U.S., South Korea, and Vietnam [11][12] - Non-GAAP research and development expenses for Q1 2021 were $2.1 million, compared to $689,000 for the same period in 2020, reflecting increased development activities [17] Market Data and Key Metrics Changes - The company is experiencing increasing interest from service providers across many countries, resulting in a growing pipeline of potential opportunities for additional MSaaS agreements [12] - The company aims to deploy an initial wave of approximately 15,000 Nanox.ARC units by the end of 2024, with a focus on expanding delivery capabilities [19] Company Strategy and Development Direction - The company is focused on a unique business model called MSaaS (Medical Screening As a Service), which employs a pay-per-scale approach, making the technology more affordable for healthcare facilities [11] - The company is building a global supply chain and ramping up manufacturing, including a semiconductor fabrication plant in South Korea, expected to be operational by mid-2022 [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in meeting the goal of deploying 15,000 units, citing strong demand and a healthy pipeline of orders [27] - The company is actively working to mitigate supply chain risks by engaging multiple suppliers for critical components, including tubes and chips [25][57] Other Important Information - The company has made significant additions to its leadership team, indicating a commitment to building a world-class team for long-term success [14] - The company plans to submit a 510(k) premarket notification to the FDA for the multi-source Nanox.ARC and Nanox.CLOUD during 2021 [10] Q&A Session Summary Question: Can you provide more detail on the delays experienced by third-party manufacturers? - Management explained that delays were related to final assembly and testing issues with the leading supplier, and they have opened two additional suppliers to mitigate risks [24] Question: What is the level of confidence in meeting the 15,000 placement goal? - Management expressed confidence in meeting the goal due to strong demand and existing contracts, despite some delays in shipments [27] Question: What are the regulatory strategies for CE and other territories? - Management stated that they plan to submit the multi-source system to the FDA and other regulatory authorities shortly after, but do not expect to take the single source for clearance in other countries [43][44] Question: What is the status of software developments during the first quarter? - Management confirmed that software development is ongoing, with the operating system and cloud management progressing as planned [46] Question: What activities will occur at the new facility in Italy? - The facility in Italy will focus on supplying tubes, serving as a mitigation plan to ensure a steady supply for production [49]
Nano-X Imaging (NNOX) - 2020 Q4 - Annual Report
2021-04-06 20:05
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 19 ...
Nano-X Imaging (NNOX) - 2020 Q4 - Earnings Call Transcript
2021-03-02 18:54
Financial Data and Key Metrics Changes - Non-GAAP net loss for Q4 2020 was $8.4 million, compared to a non-GAAP net loss of $2.8 million for Q4 2019, indicating an increase in losses [45] - Non-GAAP research and development expenses for Q4 2020 were $2.1 million, up from $1.3 million in Q4 2019, reflecting increased development activities [46] - Non-GAAP general and administrative expenses for Q4 2020 were $4.8 million, compared to $1.2 million in Q4 2019, due to investments in management and IPO-related costs [47] - Cash and cash equivalents at the end of Q4 2020 were approximately $213.5 million, with no debt, sufficient to execute the plan of manufacturing and shipping 15,000 units globally by the end of 2024 [48] Business Line Data and Key Metrics Changes - The company has executed contracts for the deployment of 5,150 systems with nine service providers in 13 countries, contingent upon regulatory approval [42] - The business model, termed MSaaS (medical-screening-as-a-service), allows healthcare facilities to access the Nanox.ARC at no upfront cost, with payments based on a pay-per-scan basis [41] Market Data and Key Metrics Changes - The company aims to deploy over 5,000 units of Nanox.ARC through MSaaS agreements and an additional 5,500 units through strategic collaborations [16] - The company is focusing on expanding the overall market for medical imaging, particularly in smaller healthcare facilities and rural areas [24] Company Strategy and Development Direction - The company is focused on building a global network to deliver imaging availability and has signed multiple agreements to facilitate this [16][31] - The strategic collaboration with Ambra Health aims to integrate medical imaging data management, enhancing the accessibility of medical images [31] - The company is investing in its Korean subsidiary for MEMs X-ray chip production, with plans for a permanent facility operational by 2022 [34] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about obtaining FDA clearance for the Nanox.ARC, expecting a response within 30 days following their comprehensive submission [55][57] - The company is committed to executing its plan and believes that the current cash reserves are sufficient to support its growth strategy [48] - Management emphasized the importance of early detection in healthcare and the potential for Nanox's technology to improve patient outcomes [24] Other Important Information - The company completed a secondary offering of approximately 3.1 million shares by certain pre-IPO shareholders, with no proceeds going to the company [49] - The company has established a strong leadership team with key hires in operational and technological roles to support its expansion [35] Q&A Session Summary Question: Confirmation of FDA response submission - Management confirmed that they submitted the response to the FDA's last set of questions [54] Question: Timing for FDA response - Management indicated that they expect to receive a response within the next 30 days [55] Question: Update on multi-source application - Management stated that they are still on track for clearance within the year and are preparing for submission [58] Question: Production locations for initial units - Initial units are being produced in Israel, with components sourced from Korea and Japan [60] Question: Commercial prospects and contract negotiations - Management highlighted the successful signing of contracts for 5,150 units and ongoing negotiations with additional service providers [68] Question: Status of Korean subsidiary - Management clarified that the Korean facility is wholly owned by Nanox, with support from SK Telecom [88]