• Fourth Quarter Revenue: $6.3 million, a 39% increase year-over-year.
• System Revenue (Q4 2024): $1.4 million, up from $0.1 million in Q4 2023.
• Recurring Revenue (Q4 2024): $4.9 million, compared to $4.5 million in Q4 2023.
• Full-Year 2024 Revenue: $26.9 million, slightly up from $26.8 million in 2023.
• Full-Year System Revenue: $8.6 million, compared to $8.7 million in 2023.
• System Backlog (Start of 2025): $15.2 million.
• Full-Year Recurring Revenue: $18.3 million, up from $18 million in 2023.
• Gross Margin (Q4 2024): Approximately 51%.
• Gross Margin (Full-Year 2024): Approximately 54%.
• Operating Expenses (Q4 2024): $10.8 million, including $2.5 million in non-cash stock compensation and $1.1 million non-cash mark-to-market adjustment.
• Adjusted Operating Expenses (Q4 2024): $7.2 million.
• Operating Loss (Q4 2024): $7.6 million.
• Net Loss (Q4 2024): $7.5 million.
• Adjusted Operating Loss (Q4 2024): $4 million.
• Adjusted Net Loss (Q4 2024): $3.8 million.
• Free Cash Flow (Q4 2024): Positive $1.3 million.
• Free Cash Flow (Full-Year 2024): Negative $8.5 million.
• Cash and Cash Equivalents (End of 2024): $12.4 million, with no debt.

• Warning! GuruFocus has detected 9 Warning Signs with STXS.

Release Date: March 03, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Stereotaxis Inc (STXS) announced significant milestones with FDA submissions for key catheter innovations, indicating progress in their strategic transformation.
• The company reported a 39% year-over-year increase in fourth-quarter revenue, totaling $6.3 million, showcasing strong financial performance.
• Stereotaxis Inc (STXS) received European CE mark approval for the GenesisX robot and MAGiC ablation catheter, with plans for commercial launch in Europe.
• The strategic acquisition of APT has enhanced Stereotaxis Inc (STXS)'s in-house catheter development and manufacturing capabilities.
• The company is expanding its product portfolio with the introduction of the EMAGIN vascular catheter, targeting multiple new endovascular indications.

Negative Points

• Stereotaxis Inc (STXS) faces challenges with FDA regulatory approval timelines, particularly for the MAGiC catheter in the US.
• The company has a system backlog of $15.2 million, indicating potential delays in revenue recognition.
• Recurring revenue growth is impacted by catheter shortages from Johnson & Johnson, affecting overall financial performance.
• Operating expenses increased due to non-cash stock compensation and acquisition-related costs, impacting profitability.
• The macroeconomic environment and anti-corruption campaigns in China present headwinds for commercial efforts in the region.

Q & A Highlights

Q: Can you provide more details on the MAGiC catheter's approval process in the US and what needs to happen for a second-half approval? A: David Fischel, Chairman and CEO, explained that they are enrolling patients in Europe to meet FDA's unmet medical need criteria. The FDA is conducting a detailed review of the PMA submission, and Stereotaxis is responding to questions and refining the submission. There might be an audit of the manufacturing facility in Germany, but it's not certain. The FDA is working collaboratively to ensure a thorough and timely review.

Q: How will the MAGiC Sweep high-density mapping catheter fit into the broader ecosystem, and how might it affect your relationship with Abbott? A: David Fischel stated that the MAGiC Sweep will be used in the majority of robotic procedures, allowing physicians to perform high-density mapping robotically. This development is part of a broader strategy and has been communicated to partners like Abbott, with no concerns about its impact on existing relationships.

Q: Can you clarify the system revenue guidance for 2025, given the GenesisX launch in Europe and China? A: David Fischel noted that the guidance is conservative, focusing on transitioning existing backlog into revenue. The unpredictability of sales in China and the timing of revenue recognition contribute to the cautious outlook. The guidance does not assume significant sales in China and reflects modest expectations for GenesisX.

Q: What is the expected timeline for GenesisX commercial approval in the US? A: David Fischel mentioned that they are responding to FDA questions and expect GenesisX approval before the compatible catheters are approved. They anticipate having at least one compatible catheter approved in the third quarter, allowing for a commercial launch in the US.

Q: What is the strategic importance of the EMAGIN vascular guidance catheter, and how do you plan to prioritize its applications? A: David Fischel emphasized that while short-term revenue expectations for EMAGIN are modest, its strategic value is substantial. The catheter will enable the robot to become a multi-specialty platform, expanding its use into neurointervention, interventional cardiology, and oncology. The focus will be on demonstrating clinical utility in these areas to expand the robot's value proposition.

Q: Is there any capacity constraint related to the MAGiC catheter, and how are you addressing it? A: David Fischel confirmed that they are ramping up manufacturing in Europe and working through administrative processes with hospitals. The goal is to ensure a steady supply as they scale up sales throughout the year.

Q: How frequently do you expect the MAGiC Sweep mapping catheter to be used, and what is the expected impact on catheter sales? A: David Fischel anticipates that the MAGiC Sweep will be used in a significant portion of procedures, potentially increasing the pool of robotic users. The combined sales of MAGiC and MAGiC Sweep are expected to increase disposable revenue per procedure by more than fivefold.

Q: What is included in the guidance for the MAGiC launch in Europe and the US? A: David Fischel clarified that the guidance includes $3 million to $4 million related to the MAGiC launch in Europe, with no revenue from a potential US launch included due to uncertainty in approval timelines.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.