I’m going to get to the nuances of Stereotaxis’ (NYSE: STXS ) quarterly report and new regulatory submissions later on, but I want to address the bears’ points first. While small cap biotech and medicalAnalyst’s Disclosure: I/we have a beneficial long position in the shares of STXS either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship ...

Company Overview - Stereotaxis has submitted an application for FDA regulatory clearance for its EMAGIN 5F catheter, which is a significant advancement in its Robotic Magnetic Navigation (RMN) technology for endovascular procedures [1][2] - The EMAGIN 5F catheter is the first robotically navigated endovascular device under the EMAGIN brand, featuring a 5-French diameter and utilizing magnetic fields for navigation [5][6] Market Potential - If approved, the EMAGIN 5F catheter could significantly expand Stereotaxis' market reach and revenue potential, particularly in neurointerventional, cardiology, and radiology procedures [2][4] - The global market for robotic catheterization systems is projected to grow from $54.4 million in 2025 to $190.2 million by 2035, driven by increasing demand for minimally invasive procedures [9][10] Financial Performance - Following the announcement of the FDA application, Stereotaxis shares fell by 5.8%, closing at $1.94, with a 6-month decline of 11.4% compared to the industry's 1.9% decline [3] - The current market capitalization of Stereotaxis stands at $174.5 million [4] Future Outlook - The company anticipates regulatory approval for the EMAGIN 5F catheter in the second half of 2025, which could enhance its competitive edge and attract strategic partnerships [2][8] - The growing preference for minimally invasive surgeries is expected to bolster the long-term outlook for Stereotaxis and its robotic technologies [10]

Financial Data and Key Metrics Changes - Revenue for Q4 2024 totaled $6.3 million, a 39% year-over-year increase compared to $4.6 million in Q4 2023 [37] - Full year revenue for 2024 was $26.9 million compared to $26.8 million in 2023 [38] - Operating loss for Q4 2024 was $7.6 million, compared to $5.3 million in Q4 2023 [41] - Adjusted operating loss for the full year 2024 was $12.8 million, compared to $11.3 million in the prior year [42] Business Line Data and Key Metrics Changes - System revenue for Q4 2024 was $1.4 million, compared to $0.1 million in Q4 2023 [37] - Recurring revenue for Q4 2024 was $4.9 million, reflecting a full quarter's contribution from the acquisition of APT, compared to $4.5 million in Q4 2023 [37] - Full year system revenue was $8.6 million, compared to $8.7 million in the prior year [38] Market Data and Key Metrics Changes - The company expects to achieve approximately $1 million of MAGIC revenue per quarter in Europe by the end of 2024 [20] - The company anticipates a few GenesisX system sales this year, scaling to double-digit numbers next year [18] Company Strategy and Development Direction - The company aims to improve endovascular surgery with robotics, focusing on four primary pillars: making the robot widely available, building an ecosystem of catheters, developing interventional devices, and establishing connectivity and AI capabilities [11][12] - A strategic acquisition of APT has enhanced the company's catheter development and manufacturing capabilities [13] - The company is focused on expanding its addressable market by introducing a family of interventional guidewires and catheters [28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the regulatory milestones and early commercial efforts setting the stage for substantial growth in 2026 [35] - The company expects to keep adjusted operating expenses flat over the next few quarters while investing in commercial capabilities funded by profits from new product launches [47] - Management noted that the existing balance sheet allows the company to reach key milestones and profitably grow [48] Other Important Information - The company has a system backlog of $15.2 million as it enters 2025 [38] - The gross margin for recurring revenue was 70%, while system gross margin was 20% [39] Q&A Session Summary Question: Can you provide more color around MAGIC in the US market? - Management indicated that patient enrollment in Europe is ongoing and that the FDA is conducting a detailed review of the PMA submission, with no definitive number of patients needed for approval [50][52] Question: How will MAGIC Sweep fit into the broader ecosystem? - Management explained that MAGIC Sweep is a high-density mapping catheter that will enhance robotic procedures by providing safety and precision, which has been a long-standing request from physicians [57][62] Question: Can you clarify the system revenue guidance for 2025? - Management stated that the guidance reflects a conservative approach due to the volatility in revenue recognition and ongoing construction timelines for system sales [68][70] Question: What is the expected timing for GenesisX commercial approval in the US? - Management expects to respond to FDA questions soon and anticipates approval before compatible catheters are available [75][76] Question: What is the revenue expectation for the EMAGIN vascular guidance catheter? - Management noted that there are no significant revenue expectations for EMAGIN in the guidance due to uncertainty around regulatory approval [80]

Stereotaxis (STXS) Q4 2024 Earnings Call March 03, 2025 06:50 PM ET Company Participants David Fischel - CEO & ChairmanKimberly Peery - CFO & Secretary Conference Call Participants Frank Takkinen - Senior Research AnalystAdam Maeder - Senior Research AnalystJason Wittes - Managing Director & Senior Research Analyst Operator Good morning. Thank you for joining us for Stereotaxis Fourth Quarter and Full Year twenty twenty four Earnings Conference Call. Certain statements during the conference call and questio ...

Stereotaxis Inc. (STXS) came out with a quarterly loss of $0.09 per share versus the Zacks Consensus Estimate of a loss of $0.05. This compares to loss of $0.07 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -80%. A quarter ago, it was expected that this company would post a loss of $0.05 per share when it actually produced a loss of $0.08, delivering a surprise of -60%.Over the last four quarters, the company has surpassed c ...

Revenue Performance - Revenue for Q4 2024 was $6.3 million, a 39% increase from $4.6 million in Q4 2023[5] - Full year 2024 revenue totaled $26.9 million, slightly up from $26.8 million in 2023[5] - System revenue for Q4 2024 was $1.4 million, while recurring revenue was $4.9 million, compared to $0.1 million and $4.5 million in Q4 2023, respectively[5] - Stereotaxis expects double-digit revenue growth for the full year 2025, with recurring revenue projected to scale from $5 million in Q1 to $7 million in Q4[9] Profitability and Loss - Gross margin for Q4 2024 was approximately 51%, with full year gross margins at 54%[6] - Operating loss for Q4 2024 was ($7.6) million, compared to ($5.3) million in Q4 2023[7] - Adjusted operating loss for the full year 2024 was ($12.8) million, compared to ($11.3) million in 2023[7] Financial Position - Cash and cash equivalents at year-end 2024 were $12.4 million, with no debt[8] - System backlog at the start of 2025 is $15.2 million[5] Future Outlook - Anticipated regulatory milestones and initial commercial launches in 2025 are expected to support substantial growth in 2026[9]

Core Insights - Stereotaxis has announced the FDA regulatory submission for the EMAGIN™ 5F, the first robotically navigated catheter aimed at expanding Robotic Magnetic Navigation into the endovascular field [1][2] - The EMAGIN brand will include a range of robotic catheters and wires, with the 5F catheter designed for navigating complex vascular structures [2] - The company anticipates launching the EMAGIN 5F in the second half of 2025, following expected regulatory approvals [3][4] Company Overview - Stereotaxis is a leader in surgical robotics for minimally invasive endovascular interventions, with a mission to develop robotic systems that enhance patient care and operational efficiency [5] - The technology has been utilized in over 150,000 procedures globally, indicating a strong market presence and acceptance [5] Industry Impact - Robotic Magnetic Navigation is positioned to address significant clinical challenges in neurointerventional and interventional cardiology, enhancing safety and precision in complex procedures [3][4] - Experts in the field express optimism about the potential of the EMAGIN catheter to improve outcomes in various challenging medical procedures [3]

Core Insights - Stereotaxis has announced the FDA regulatory submission for the MAGiC Sweep™ catheter, marking a significant advancement in surgical robotics for minimally invasive endovascular interventions [1][3] - The MAGiC Sweep is the first high-density electrophysiology (EP) mapping catheter designed for robotic navigation, which is expected to enhance cardiac ablation procedures through improved mapping capabilities [2][3] Company Developments - The MAGiC Sweep catheter allows for rapid and detailed electroanatomical mapping from 20 electrodes, improving safety and accuracy in mapping difficult areas of the heart [2][3] - Stereotaxis plans to submit the MAGiC Sweep for European CE Mark clearance and anticipates a broad commercial launch in the second half of the year following expected regulatory approvals [3][4] - The company has also introduced the EMAGIN 5F vascular guidance catheter, indicating a strategic expansion of its product portfolio [4] Industry Impact - The introduction of the MAGiC Sweep catheter is seen as a major milestone in the EP field, potentially transforming the approach to arrhythmia treatment by enabling high-resolution mapping [3] - Stereotaxis aims to solidify its position as a leader in robotic technology with a diverse range of proprietary catheters, reflecting its commitment to innovation in surgical robotics [4]

Core Insights - Stereotaxis reported a 39% year-over-year revenue growth in Q4 2024, reaching $6.3 million, driven by increased robotic system revenue and successful integration of APT [4][6] - The company achieved several regulatory milestones, including European approval for the MAGiC catheter and the first sale of the GenesisX robot, which are expected to enhance commercial growth [3][4] - Stereotaxis anticipates double-digit revenue growth for the full year 2025, with recurring revenue projected to scale from $5 million in Q1 to $7 million in Q4 [8][9] Financial Performance - Q4 2024 revenue was $6.3 million, up from $4.6 million in Q4 2023, with system revenue at $1.4 million and recurring revenue at $4.9 million [4][6] - Full year 2024 revenue totaled $26.9 million, slightly up from $26.8 million in 2023, with a system backlog of $15.2 million at the start of 2025 [4][6] - Gross margins for Q4 and full year 2024 were approximately 51% and 54%, respectively, with recurring revenue gross margins at 70% and system revenue at 20% [5][6] Cash Flow and Balance Sheet - Stereotaxis generated positive cash flow of $1.3 million in Q4 2024, ending the year with over $12 million in cash and no debt [6][7] - The company reported a negative free cash flow of $8.5 million for the full year 2024, an improvement from $9.5 million in 2023 [6][10] - Total assets increased to $46.7 million in 2024 from $41.9 million in 2023, while total liabilities rose to $35.3 million from $20.0 million [17][19] Strategic Outlook - The company is focused on expanding its catheter portfolio and expects modest contributions from new innovations initially, with potential for breakout growth in the future [3][9] - Stereotaxis aims to reduce cash use in 2025 compared to the previous year, supported by growing recurring revenue and stable operating expenses [10]

Core Insights - Stereotaxis is participating in TD Cowen's 45th Annual Healthcare Conference, with CEO David Fischel presenting on March 3, 2025 [1][2] - The company aims to share its progress and strategy during the conference [2] Company Overview - Stereotaxis is a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention [3] - The company's mission focuses on the discovery, development, and delivery of robotic systems, instruments, and information solutions for interventional laboratories [3] - Stereotaxis technology has been utilized to treat over 150,000 patients globally, including in the United States, Europe, and Asia [3]