Workflow
Stereotaxis(STXS)
icon
Search documents
Stereotaxis(STXS) - 2022 Q3 - Quarterly Report
2022-11-14 16:03
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (MARK ONE) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO COMMISSION FILE NUMBER 001-36159 STEREOTAXIS, INC. (Exact name of the Registrant as Specified in its Charter) DELAWARE 94-3120386 (State or Other Juris ...
Stereotaxis(STXS) - 2022 Q3 - Earnings Call Transcript
2022-11-10 21:12
Financial Data and Key Metrics Changes - Revenue for Q3 2022 totaled $7.7 million, with recurring revenue consistent at $5.3 million compared to the prior year, while system revenue decreased to $2.4 million from $3.5 million due to hospital construction delays [26][27] - Gross margin for the quarter was 60%, with system gross margin at 16% and recurring revenue gross margin at 80, impacted by low production volume and significant fixed overhead expenses [27] - Operating loss and net loss for Q3 2022 were $5.1 million and $4.9 million, respectively, compared to $4.6 million for both in the previous year [29] - Negative free cash flow for the quarter was $2.7 million, significantly impacted by one-time expenses for a new headquarters and manufacturing facility, as well as an investment in inventory [30] Business Line Data and Key Metrics Changes - The company received 2 system orders during Q3, including a Genesis system in the U.S. and a Niobe system in China, with a strong start to Q4 with 2 signed purchase contracts [4][5] - The capital backlog expanded to over $13 million, or over $16 million including recent signed contracts, indicating a healthy pipeline of prospects across focused geographies [6][34] Market Data and Key Metrics Changes - Hospital construction timelines remain slow, impacting revenue recognition, but orders in the backlog are guaranteed with significant nonrefundable down payments [7][60] - The company noted that approximately half of its procedure volume comes from Europe and Asia, with a 15% year-over-year foreign exchange impact on revenue due to a strengthening U.S. dollar [66] Company Strategy and Development Direction - The company is focused on generating growth in orders and ensuring successful experiences with existing robotic practices, which is expected to positively reflect in financial statements [8][9] - The strategic innovation plan includes the development of the MAGiC catheter, mobile robot, and collaborations with MicroPort, aiming to transform endovascular surgery with robotics [13][20] - The company plans to offer multiple financial access options for the mobile robot, including purchase, lease, or disposable purchase commitments, to facilitate adoption [72] Management's Comments on Operating Environment and Future Outlook - Management acknowledged challenges in predicting system revenue and decided to avoid specific revenue guidance until forecasting abilities improve [32] - The existing system backlog and capital pipeline are expected to support year-over-year revenue growth in the coming quarters, with new technology launches anticipated to drive substantial growth [33][34] - The macro environment remains challenging, with hospitals facing financial and staffing pressures, but the company is pleased with order activity and pipeline shaping up positively [81][82] Other Important Information - The MAGiC Ablation catheter's CE Mark submission was made in July, and the technical review is currently underway, with expectations for U.S. FDA approval approximately two years after submission [14][16] - The collaboration with MicroPort in China is progressing well, with regulatory submissions and commercial preparations advancing in tandem [18][21] Q&A Session All Questions and Answers Question: Can you provide color around backlog and revenue recognition? - The backlog was over $13 million at the end of the quarter, and it is expected to convert to revenue within a year, although some orders may take longer [39][40] Question: What is the status of the MAGiC RF catheter CE Mark approval? - The completeness check was successful, and the technical review is ongoing, with confidence in the quality of the submission [44][45] Question: How is the sales funnel shaping up? - There are over a dozen opportunities in the U.S. and Europe, with a growing number in China, as the company tracks the sales funnel more systematically [52][53] Question: What is happening with construction timeline variability? - The delays are primarily due to staffing issues and engagement with external contractors, rather than budget approval [60][61] Question: What is the status of the mobile robot system? - The initial launch is still on track for next summer, with submissions expected in the first half of next year [67][68] Question: How is the company preparing the commercial organization for the mobile robot? - The focus is on building a robust capital sales capability in Europe, with plans to offer multiple financial access options for customers [78][72] Question: What is the current state of the market in China? - The company is seeing positive developments with MicroPort, and while the sales funnel has been driven by Stereotaxis, MicroPort is beginning to build its sales capability [89][95]
Stereotaxis(STXS) - 2022 Q2 - Quarterly Report
2022-08-11 17:05
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (MARK ONE) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO COMMISSION FILE NUMBER 001-36159 STEREOTAXIS, INC. (Exact name of the Registrant as Specified in its Charter) DELAWARE 94-3120386 (State or Other Jurisdicti ...
Stereotaxis(STXS) - 2022 Q2 - Earnings Call Transcript
2022-08-09 19:39
Stereotaxis, Inc. (NYSE:STXS) Q2 2022 Earnings Conference Call August 9, 2022 10:00 AM ET Company Representatives David Fischel - Chairman, Chief Executive Officer Kim Peery - Chief Financial Officer Conference Call Participants Josh Jennings - Cowen Adam Maeder - Piper Sandler Neil Chatterji - B. Riley Alex Nowak - Craig-Hallum Capital Group Frank Takkinen - Lake Street Capital Markets Nathan Weinstein - Aegis Capital Javier Fonseca - Spartan Capital Operator Good morning! Thank you for joining us for Ster ...
Stereotaxis(STXS) - 2022 Q1 - Earnings Call Presentation
2022-05-12 14:25
INVESTOR PRESENTATION 1Q 2022 FORWARD LOOKING STATEMENT 2 During the course of this presentation, the Company may make projections and other forward-looking statements regarding future events or the future financial performance of the Company, including without limitation, statements regarding future operating results, growth opportunities and other statements that refer to Stereotaxis' plans, prospects, expectations, strategies, intentions and beliefs. These statements are subject to many risks and uncerta ...
Stereotaxis(STXS) - 2022 Q1 - Quarterly Report
2022-05-11 13:05
Impact of COVID-19 - Stereotaxis reported a significant decline in procedures during the COVID-19 pandemic, with U.S. and European procedures dropping to approximately 70% of pre-pandemic levels at the peak [126]. - The ongoing impact of the pandemic is expected to cause significant disruptions to procedure volumes and system placements in 2022 [131]. - The company anticipates challenges in supply chain and logistics due to the pandemic, affecting its ability to source parts and ship products [130]. Financial Performance - Revenue decreased from $8.6 million for the three months ended March 31, 2021, to $7.0 million for the three months ended March 31, 2022, a decrease of 18% [157]. - Revenue from system sales decreased to $1.6 million for the three months ended March 31, 2022, from $2.6 million for the same period in 2021 [157]. - Cost of revenue decreased from $2.6 million for the three months ended March 31, 2021, to $2.1 million for the same period in 2022, a decrease of approximately 19% [158]. - General and administrative expenses increased from $2.2 million for the three months ended March 31, 2021, to $3.6 million for the same period in 2022, an increase of approximately 62% [160]. - Cash flow used in operating activities was approximately $2.2 million for the three months ended March 31, 2022, compared to $0.3 million for the same period in 2021 [163]. - As of March 31, 2022, the Company had $36.9 million of cash and cash equivalents, inclusive of restricted cash [163]. Product and Technology - The Genesis RMN System and Odyssey Solution are key products designed to improve procedure efficiency and reduce x-ray exposure during cardiac interventions [120][121]. - The company has treated over 100,000 arrhythmia patients globally using its robotic technology, supported by over 400 clinical publications [118]. - Stereotaxis has received regulatory clearances for the Genesis RMN System in the U.S. and Europe, and is pursuing additional registrations in other countries [124]. Revenue Recognition - The company generates revenue from initial system sales, recurring sales of disposable devices, and royalties from co-developed catheters [134]. - Revenue from disposable products is recognized upon shipment or delivery, while system sales revenue is recognized upon customer acceptance [140][139]. Expenses and Liabilities - Research and development expenses remained consistent at $2.4 million for the three months ended March 31, 2021, and 2022 [159]. - The Company recorded a right-of-use asset and lease liability of $5.9 million related to a new office lease agreement [151]. - The Company recognized a net gain from debt extinguishment of approximately $2.2 million upon forgiveness of the Paycheck Protection Program loan [167]. Strategic Relationships - Strategic relationships with technology leaders are critical for the commercialization of Stereotaxis' robotic systems and devices [125].
Stereotaxis(STXS) - 2022 Q1 - Earnings Call Transcript
2022-05-10 20:16
Stereotaxis, Inc. (NYSE:STXS) Q1 2022 Earnings Conference Call May 10, 2022 10:00 AM ET Company Participants David Fischel - Chairman and CEO Kim Peery - Chief Financial Officer Conference Call Participants Frank Takkinen - Lake Street Capital Market Adam Maeder - Piper Sandler Alex Nowak - Craig-Hallum Capital Group Jason Wittes - Loop Capital Javier Fonseca - Spartan Capital Operator Good morning. Thank you for joining us for Stereotaxis' First Quarter 2022 Earnings Conference Call. Certain statements dur ...
Stereotaxis(STXS) - 2021 Q4 - Annual Report
2022-03-10 19:31
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (MARK ONE) ☒ 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 FOR THE TRANSITION PERIOD FROM TO COMMISSION FILE NUMBER 001-36159 STEREOTAXIS, INC. (Exact name of the Registrant as Specified in its Charter) DELAWARE 94-3120386 (State or Other Jurisdiction o ...
Stereotaxis(STXS) - 2021 Q4 - Earnings Call Transcript
2022-03-03 21:37
Financial Data and Key Metrics Changes - Revenue for Q4 2021 totaled $8.2 million, a 21% increase from the prior year, while full-year revenue reached $35 million, growing 32% from $26.6 million in 2020 [49] - Recurring revenue for Q4 was $5.7 million, and system revenue was $2.3 million; full-year recurring revenue was $22.9 million, a 4% increase from the previous year [49] - Gross margin for Q4 was 72%, and for the full year, it was 66%, with recurring revenue gross margins at 86% and system revenue at 33% [50] - Operating loss for Q4 was $3.4 million, compared to $1.2 million in the previous year; adjusted operating loss for the full year was $3.6 million [53][54] - Cash and cash equivalents at year-end were $40.1 million, with no debt [55] Business Line Data and Key Metrics Changes - In 2021, Stereotaxis sold seven systems globally, with three in the U.S., two in Europe, and two in China, marking a restart in capital sales [23][25] - The company expects a similar level of greenfield capital sales as last year and some growth in replacement capital, but still below normalized levels [58] Market Data and Key Metrics Changes - The company noted a pipeline of over a couple dozen high-likelihood capital projects globally, reflecting a good mix of both greenfield and replacement projects [28] - The impact of COVID-19 and supply chain issues has delayed some orders, particularly in the replacement market [70][98] Company Strategy and Development Direction - Stereotaxis aims to transform endovascular surgery with robotics, focusing on building a product ecosystem that includes a mobile robotic navigation system, an independent ablation catheter portfolio, and a digital platform for operating room connectivity [32][34] - The company is investing in R&D, with 30% of revenue allocated to it in 2021, and expects this to increase to around 35% in 2022 [16][137] Management's Comments on Operating Environment and Future Outlook - Management anticipates revenue growth in 2022 driven by continued adoption of the Genesis RMN system and stable recurring revenue [57] - The company is facing macro headwinds that affect the timing of orders and hospital construction schedules, impacting revenue recognition [70][96] Other Important Information - The company has launched a new generation simulator for training physicians, enhancing engagement and clinical knowledge in the field [20] - Stereotaxis has a collaboration with MicroPort EP to develop a product ecosystem for cardiac ablation in China, which is expected to contribute to growth [44][109] Q&A Session Summary Question: What is the outlook for system revenue in 2022? - Management indicated that the expectation of doubling system revenue has been adjusted due to delays in replacement orders, with guidance now reflecting similar greenfield numbers and more replacement than last year, but not at normalized levels [67][72] Question: What are the expectations for disposable revenue in 2022? - Management expects disposable revenue to remain stable relative to 2021 levels, with potential contributions from new disposable devices later in the year [75][79] Question: Can you provide updates on the four orders in backlog? - Management stated that at least half of the four orders in backlog are expected to contribute to revenue in the second half of the year, based on hospital delivery schedules [105] Question: What is the status of the collaboration with MicroPort in China? - The collaboration is focused on developing a product ecosystem, with commercial engagements ongoing, but full commercialization will depend on the completion of regulatory approvals and product integration [109][112] Question: How is the company managing supply chain challenges? - Management reported constant disturbances in the supply chain but noted that there has not been a material impact on production for revenue [121]
Stereotaxis Inc. (STXS) Investor Presentation - Slideshow
2022-02-21 12:01
Company Overview - Stereotaxis is a global leader in robotic technology for minimally invasive endovascular surgery[4] - The company focuses on the electrophysiology market, estimated at over $6 billion, with an annual total addressable market (TAM) exceeding $10 billion[4] - Stereotaxis has a solid financial foundation with $40 million in cash and no debt, and operations are near breakeven[4] Benefits of Robotic Magnetic Navigation (RMN) - RMN offers 1mm precision, tip stability, and extended reach in endovascular procedures[17] - RMN provides radiation protection and intuitive navigation for physicians[17] - Clinical data indicates a 36% average reduction in radiation exposure with RMN compared to manual cardiac ablation[19, 61] Clinical Outcomes - A comprehensive review of clinical literature shows a 72% average reduction in major adverse events with robotic navigation[57] - Studies show that acute efficacy rates are high with robotic navigation, reaching 91.86% in some studies[67, 69] - Long-term efficacy studies demonstrate a 72.64% freedom from recurrence rate with robotic navigation[72, 73] Commercial and Innovation Strategy - The company has an established commercial infrastructure and is focused on strategic innovation[31, 34] - Stereotaxis is expanding into accessible robotics, ablation catheters, and broader endovascular indications, targeting a $10 billion+ TAM[50] - The company is pursuing geographic expansion through strategic collaborations, including a collaboration with MicroPort EP for leadership in China[50]