Stereotaxis(STXS)

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Stereotaxis Receives CE Mark For GenesisX, Nears MAGiC Approval
Seeking Alpha· 2024-08-25 23:22
eternalcreative/iStock via Getty Images Initial Takeaways From Q2 Report: GenesisX Submissions/Approval & MAGiC Making Progress Heading into the Q2 earnings report, I was most concerned about the GenesisX submission timeline. Stereotaxis (NYSE:STXS) management originally projected the robot would be submitted to regulators in late 2022. That guidance was way too aggressive. Then, in mid to late 2023, the firm suggested the robot was nearly ready for regulatory submission, but the company wanted to wait unti ...
Stereotaxis(STXS) - 2024 Q2 - Quarterly Report
2024-08-14 17:40
Acquisition and Product Development - The Company issued 1,486,620 shares of its common stock as part of the acquisition of Access Point Technologies, Inc. (APT) on July 31, 2024[103]. - APT specializes in high-quality diagnostic catheters for cardiac ablation procedures, enhancing the Company's capabilities in treating complex arrhythmias[103]. - The acquisition includes contingent payments based on achieving specified product revenue and regulatory approval milestones through September 30, 2029[104]. - The primary clinical focus is on electrophysiology, specifically cardiac ablation, which is a multi-billion-dollar market with expected long-term growth[96]. - The Genesis RMN System and Odyssey Solution are key products designed to improve procedure efficiency and reduce x-ray exposure during interventions[98][99]. - The Company has received regulatory approvals for its products in the U.S., Europe, Canada, China, and Japan, and is pursuing additional registrations globally[101]. Financial Performance - Revenue decreased from $7.9 million for the three months ended June 30, 2023, to $4.5 million for the three months ended June 30, 2024, a decrease of 43%[120]. - Revenue from sales of systems decreased to $0.2 million for the three months ended June 30, 2024, from $3.3 million for the same period in 2023, driven by decreased system sales volumes[120]. - Overall gross margin increased to 74% for the three months ended June 30, 2024, from 53% for the same period in 2023, primarily due to changes in product mix[121]. - Revenue decreased from $14.4 million for the six months ended June 30, 2023, to $11.4 million for the same period in 2024, a decrease of approximately 21%[123]. - Cost of revenue decreased from $6.3 million for the six months ended June 30, 2023, to $4.1 million for the same period in 2024, a decrease of approximately 35%[124]. Expenses and Cash Flow - Research and development expenses decreased from $2.6 million for the three months ended June 30, 2023, to $2.3 million for the same period in 2024, a decrease of approximately 14%[122]. - General and administrative expenses increased from $3.5 million for the three months ended June 30, 2023, to $3.8 million for the same period in 2024, an increase of approximately 8%[123]. - Cash and cash equivalents as of June 30, 2024, were $15.2 million, down from $20.0 million as of December 31, 2023[127]. - Net cash used in operating activities was approximately $5.4 million for the six months ended June 30, 2024, compared to $5.7 million for the same period in 2023[127]. - The Company did not have any debt as of June 30, 2024[129]. Market and Operational Challenges - Supply chain disruptions and inflationary pressures continue to pose risks to the Company's operations and financial condition[105]. - The ongoing impact of the COVID-19 pandemic has affected demand for the Company's systems and disposable products, leading to potential revenue fluctuations[107].
Stereotaxis(STXS) - 2024 Q2 - Earnings Call Transcript
2024-08-13 03:33
Financial Data and Key Metrics Changes - Revenue for Q2 2024 totaled $4.5 million, down from $7.9 million in Q2 2023, primarily due to delayed system deliveries [30] - System revenue was $0.2 million, while recurring revenue was $4.3 million compared to $3.3 million and $4.6 million in the prior year [30] - Gross margin for Q2 2024 was 74%, with recurring revenue gross margin at 76% and system gross margin at 22% [31] - Operating loss for Q2 2024 was $6 million, compared to $5.3 million in the previous year [32] - Cash and cash equivalents at June 30 were $15.2 million with no debt [32] Business Line Data and Key Metrics Changes - The company maintains a system backlog of $15.3 million as of the end of Q2 2024, indicating potential future revenue recognition [30] - The company expects to end the year with approximately $13 million in cash and no debt, reflecting confidence in upcoming revenue milestones [6][34] Market Data and Key Metrics Changes - The company has an active late-stage sales pipeline in all three key geographies, indicating strong market interest [6] - There are currently two Genesis systems in transit to European customers, with revenue recognition expected upon delivery [4] Company Strategy and Development Direction - The company is focused on strategic transformation, including the introduction of GenesisX and MAGiC, which are expected to enhance market presence and revenue potential [7][15] - The acquisition of Access Point Technologies (APT) is aimed at enhancing in-house catheter development and manufacturing capabilities, which will support future innovation [20][23] - The company plans to transition from a construction model to a placement model with GenesisX, simplifying installation and increasing accessibility for customers [11][13] Management's Comments on Operating Environment and Future Outlook - Management acknowledged disappointing quarterly results but expressed confidence in a significantly stronger second half of the year, expecting over $14 million in revenue [33][34] - The company is aware of macroeconomic challenges but believes it can navigate these through its existing pipeline and strategic initiatives [62] Other Important Information - The company has made significant progress in regulatory approvals for both GenesisX and MAGiC, with expectations for commercial launches in 2025 [14][15] - The company is advancing towards regulatory approval for the MAGiC catheter, which is crucial for its commercialization strategy [16][18] Q&A Session Summary Question: Can you provide an update on the MAGiC catheter and its CE mark status? - Management confirmed that two out of three areas of review for the CE mark have been passed, and they are awaiting microbiology questions [36][38] Question: What is the pricing strategy for GenesisX and its launch timeline? - Management indicated that GenesisX will command a premium over Genesis, with various sales models including outright purchase, leasing, and placement with disposable commitments [40][42] Question: Can you elaborate on the MAGiC-FEST study results? - Management stated that the MAGiC-FEST study is ongoing, with positive performance noted, and additional data is being prepared for publication [49][50] Question: How does the company plan to scale manufacturing for GenesisX? - Management expressed confidence in scaling manufacturing efficiently, with expectations to produce more systems than with previous models [58] Question: Are macroeconomic factors affecting capital equipment purchasing patterns? - Management acknowledged some macro headwinds but emphasized that they have a solid pipeline of engaged customers across key markets [62]
Stereotaxis Inc. (STXS) Reports Q2 Loss, Lags Revenue Estimates
ZACKS· 2024-08-12 22:21
Stereotaxis Inc. (STXS) came out with a quarterly loss of $0.07 per share versus the Zacks Consensus Estimate of a loss of $0.04. This compares to loss of $0.07 per share a year ago. These figures are adjusted for nonrecurring items. This quarterly report represents an earnings surprise of -75%. A quarter ago, it was expected that this company would post a loss of $0.07 per share when it actually produced a loss of $0.06, delivering a surprise of 14.29%. Over the last four quarters, the company has surpasse ...
Stereotaxis(STXS) - 2024 Q2 - Quarterly Results
2024-08-12 20:07
Exhibit 99.1 Stereotaxis Reports 2024 Second Quarter Financial Results ST. LOUIS, August 12, 2024 (GLOBE NEWSWIRE) – Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today reported financial results for the second quarter ended June 30, 2024. "We made significant progress over the last quarter on strategic innovation efforts that are establishing a solid foundation upon which to build a substantial and successful company," said Davi ...
Stereotaxis Reports 2024 Second Quarter Financial Results
GlobeNewswire News Room· 2024-08-12 20:05
ST. LOUIS, Aug. 12, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today reported financial results for the second quarter ended June 30, 2024. "We made significant progress over the last quarter on strategic innovation efforts that are establishing a solid foundation upon which to build a substantial and successful company," said David Fischel, Chairman and CEO. "Key milestones achieved include successful ...
Stereotaxis Achieves CE Mark in Europe and Submits 510(k) in the US for Next Generation Robotic System GenesisX
GlobeNewswire News Room· 2024-08-12 20:03
Latest innovation in Robotic Magnetic Navigation technology supports broad accessibility of robotics for minimally-invasive endovascular surgery GenesisX has obtained CE mark in Europe and has been submitted to the FDA for 510(k) clearance in the United States ST. LOUIS, Aug. 12, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced it obtained CE mark in Europe and submitted a 510(k) application ...
Stereotaxis to Report Second Quarter 2024 Financial Results on August 12, 2024
GlobeNewswire News Room· 2024-07-22 20:05
ST. LOUIS, July 22, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it will release financial results for its 2024 second quarter on Monday, August 12, 2024 at the close of the U.S. financial markets. The Company will host a conference call and webcast at 4:30 p.m. EST that day to discuss the Company's results and corporate developments. What: Stereotaxis second quarter 2024 financial r ...
Stereotaxis Strengthens Board of Directors with Appointment of Nachum Shamir
GlobeNewswire News Room· 2024-07-18 20:13
ST. LOUIS, July 18, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer in surgical robotics for minimally invasive endovascular intervention, today announced the appointment of Nachum "Homi" Shamir to its Board of Directors. Mr. Shamir most recently served as Chairman and Chief Executive Officer of Luminex Corporation from 2014 through its sale to DiaSorin S.p.A. for $1.8 Billion in 2021. Prior to Luminex, Mr. Shamir served as President and Chief Executive Officer of Given Imaging from 2006 throug ...
Penn Presbyterian Medical Center Becomes First Hospital in the Northeast to Adopt Advanced Robotic Technology for Heart Treatment
globenewswire.com· 2024-05-29 12:25
ST. LOUIS, May 29, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer in surgical robotics for minimally invasive endovascular intervention, today announces the successful treatment of the first heart rhythm patients by Penn Presbyterian Medical Center (PPMC) utilizing the advanced Genesis Robotic Magnetic Navigation System. PPMC, part of the University of Pennsylvania Health System, renowned for advanced clinical research, innovation, and compassionate patient care, stands at the forefront as the ...