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Stereotaxis(STXS) - 2023 Q4 - Earnings Call Transcript
2024-03-04 23:57
Financial Data and Key Metrics Changes - Revenue for the full year 2023 totaled $26.8 million, a decrease from $28.1 million in 2022 [36] - Gross margin for the fourth quarter and full year 2023 were approximately 60% and 56% of revenue, with full year gross margins of 79% on recurring revenue and 8% for system revenue [15][36] - Operating loss for the fourth quarter of 2023 was $5.3 million compared to $4.5 million in the previous year [37] - Adjusted operating loss for the full year 2023 was $11.3 million compared to $8.3 million in the prior year [133] Business Line Data and Key Metrics Changes - System revenue for the full year was $8.7 million compared to $6.8 million in the prior year, reflecting increased system deliveries and installations [132] - Recurring revenue for the full year was $18 million compared to $21.3 million, impacted by the absence of J&J royalties and periodic catheter shortages [132][130] Market Data and Key Metrics Changes - The company began 2024 with a backlog of $14.7 million from orders that were received but not yet shipped or installed [12] - The company expects recurring revenue to remain stable until the MAGiC catheter can contribute to disposable revenue growth [17] Company Strategy and Development Direction - The company is focused on addressing structural weaknesses in its product ecosystem and has developed a proprietary ablation catheter, the MAGiC catheter, to enhance its offerings [6][27] - The company plans to leverage its collaboration with MicroPort to establish a China-specific EP product ecosystem and expects regulatory approval for the Genesis robot in China midyear [127] - The company aims for a full launch of its digital surgery platform, Sync, to enhance operating room connectivity [10][32] Management's Comments on Operating Environment and Future Outlook - Management acknowledges that progress has taken longer than expected but sees key regulatory submissions and technology developments aligning this year [11] - The company expects overall double-digit revenue growth for 2024 driven by system revenue growth from its backlog and new orders [17] - Management expressed confidence in the regulatory submissions for the MAGiC catheter and anticipates a collaborative review process with the FDA [64][90] Other Important Information - The company has a strong balance sheet with approximately $20 million in cash and no debt, allowing it to advance its product ecosystem to market [13][16] - The company has invested in significant inventory and has direct commercial teams globally to launch new products as they become available [105] Q&A Session All Questions and Answers Question: What is the outlook for MAGiC catheter submissions? - The EU submission is a resubmission with additional clinical data, and the company expects a more efficient review process [19][110] Question: How quickly can the company ramp up manufacturing for MAGiC? - The company has demonstrated capability to scale manufacturing and produced nearly 1,000 units during regulatory testing [73] Question: What is the plan for the sales force with the MAGiC launch? - The existing sales teams will be utilized for the MAGiC launch, with incremental hiring planned as revenue grows [82][150] Question: What is the expected revenue for the first quarter of 2024? - The company expects revenue of approximately $7 million for the first quarter of 2024 [134]
Stereotaxis(STXS) - 2023 Q4 - Annual Results
2024-03-04 21:06
Exhibit 99.1 Stereotaxis Reports 2023 Full Year Financial Results ST. LOUIS, MO, Mar. 4, 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 fourth quarter and full year ended December 31, 2023. "We enter 2024 having made significant progress in realizing our strategic transformation. This is the year in which we expect all the key puzzle pieces to come together, setting ...
Stereotaxis(STXS) - 2023 Q3 - Quarterly Report
2023-11-13 14:05
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 SEPTEMBER 30, 2023 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) - 2023 Q3 - Earnings Call Transcript
2023-11-09 19:42
Financial Data and Key Metrics Changes - Revenue for Q3 2023 totaled $7.8 million, up 2% from $7.7 million in the prior year [24] - Operating loss and net loss for Q3 were $5.6 million and $5.4 million, compared to $5.1 million and $4.9 million in the previous year [5] - Gross margin for Q3 2023 was 52% of revenue, with recurring revenue gross margin at 80% and system gross margin at 18% [25] - Negative free cash flow for Q3 was $1 million, with cash and cash equivalents at $23 million and no debt [6] Business Line Data and Key Metrics Changes - System revenue of $3.5 million reflects revenue recognition on the delivery of two Genesis systems [24] - Recurring revenue for the quarter was $4.3 million, predominantly impacted by the absence of J&J royalty and residual pressure on procedures [24] - The company recognized revenue from the adoption of Genesis by both Greenfield new accounts and existing upgrade customers [13] Market Data and Key Metrics Changes - The company has seen strengths in capital activity out of Europe, benefiting from enhanced commercial leadership and greater market appreciation for upcoming innovations [14] - In contrast, several projects in China have been delayed due to a countrywide anti-corruption drive, freezing hospital capital purchasing activity [15] Company Strategy and Development Direction - The company is actively driving a broad-based comprehensive innovation strategy forward, including the development of MAGiC and a smaller self-shielding robot [2][16] - The innovation strategy aims to expand the clinical use of the robotic platform beyond electrophysiology to various endovascular procedures [22] - The company plans to submit a PMA supplement for MAGiC using existing data, aiming to accelerate access for US physicians and patients [18] Management's Comments on Operating Environment and Future Outlook - Management remains confident in the ability to advance the innovation strategy to market and reach profitability without additional financings [8] - The company acknowledges the importance of maintaining financial strength in the current macro environment while delivering commercial results [8] - Management expressed optimism about the impact of the innovation strategy and the potential for growth beyond the current backlog [1][24] Other Important Information - The company has a cash balance expectation of $22 million by year-end with no debt [6] - The company is working on regulatory submissions for MAGiC and expects to receive responses from European health authorities soon [17] Q&A Session Questions and Answers Question: What is being done differently in Europe to drive increased activity? - The new leadership in Europe has implemented a disciplined process and is leveraging product ecosystem aspects, including the anticipation of MAGiC approval [28] Question: Can you clarify the expectations for revenue growth in 2023? - Management indicated that while they are confident in growth in the coming quarters, they are not certain about achieving annualized double-digit revenue growth based on fourth-quarter results [46] Question: What is the timeline for collecting data in Europe for MAGiC? - The trial is structured to capture acute clinical data from 20 patients, with the potential to enroll up to 30 patients at each of the three sites [67] Question: How does the company view the replacement cycle for its systems? - A significant majority of the installed base is over 10 years old, indicating a ripe opportunity for replacement, although the replacement cycle is still tied to X-ray system replacements [65][66]
Stereotaxis(STXS) - 2023 Q2 - Quarterly Report
2023-08-11 13:05
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, 2023 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) - 2023 Q2 - Earnings Call Transcript
2023-08-10 20:29
Stereotaxis, Inc. (NYSE:STXS) Q2 2023 Earnings Conference Call August 10, 2023 10:00 AM ET Company Participants David Fischel - Chairman & Chief Executive Officer Kimberly Peery - Chief Financial Officer Conference Call Participants Frank Takkinen - Lake Street Capital Markets Adam Maeder - Piper Sandler Alex Nowak - Craig-Hallum Capital Josh Jennings - TD Cowen Neil Chatterji - B. Riley Securities Operator Good morning. Thank you for joining us for Stereotaxis' Second Quarter 2023 Earnings Conference Call. ...
Stereotaxis(STXS) - 2023 Q1 - Quarterly Report
2023-05-12 21:01
Part I Financial Information [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The unaudited consolidated financial statements for Q1 2023 show a net loss of **$5.3 million**, with total assets decreasing to **$50.7 million** [Balance Sheets](index=4&type=section&id=Balance%20Sheets) Total assets decreased to **$50.7 million** by March 31, 2023, driven by reduced cash, and equity declined to **$23.7 million** Consolidated Balance Sheet Summary (in thousands) | Account | March 31, 2023 (USD) | December 31, 2022 (USD) | | :--- | :--- | :--- | | **Current Assets** | | | | Cash and cash equivalents | $5,623 | $8,586 | | Short-term investments | $20,041 | $19,844 | | Total current assets | $40,905 | $43,246 | | **Total Assets** | **$50,711** | **$53,413** | | **Current Liabilities** | | | | Total current liabilities | $14,269 | $14,291 | | **Total Liabilities** | **$21,418** | **$21,484** | | **Total Stockholders' Equity** | **$23,710** | **$26,346** | | **Total Liabilities and Stockholders' Equity** | **$50,711** | **$53,413** | [Statements of Operations](index=5&type=section&id=Statements%20of%20Operations) Q1 2023 total revenue decreased **7%** to **$6.5 million**, leading to a **$5.6 million** operating loss and **$5.7 million** net loss Statement of Operations Summary (in thousands, except per share data) | Metric | Q1 2023 (USD) | Q1 2022 (USD) | | :--- | :--- | :--- | | Total Revenue | $6,548 | $7,037 | | Gross Margin | $3,876 | $4,924 | | Total Operating Expenses | $9,495 | $9,013 | | Operating Loss | $(5,619) | $(4,089) | | Net Loss | $(5,347) | $(4,086) | | Net Loss per Share (Basic & Diluted) | $(0.07) | $(0.06) | [Statements of Cash Flows](index=8&type=section&id=Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$2.8 million** in Q1 2023, with total cash balances decreasing to **$6.8 million** Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2023 (USD) | Three Months Ended March 31, 2022 (USD) | | :--- | :--- | :--- | | Net cash used in operating activities | $(2,802) | $(2,193) | | Net cash used in investing activities | $(349) | $(1,154) | | Net cash provided by financing activities | $56 | $54 | | **Net decrease in cash, cash equivalents, and restricted cash** | **$(3,095)** | **$(3,293)** | [Notes to Financial Statements](index=9&type=section&id=Notes%20to%20Financial%20Statements) Notes detail business operations, accounting policies, cardiac ablation focus, supply chain risks, and stock-based compensation - The company's primary products are the Genesis RMN System and the Odyssey Solution, focusing on cardiac ablation procedures for arrhythmias, with an aspiration to expand into other endovascular indications[25](index=25&type=chunk)[27](index=27&type=chunk) - The company continues to face risks from supply chain disruptions, inflation, and hospital staffing shortages, which can impact procedure volumes, system installations, and operating costs[37](index=37&type=chunk)[38](index=38&type=chunk)[40](index=40&type=chunk) - In April 2023, all outstanding shares of Series B Convertible Preferred Stock were converted into common stock on a one-for-one basis[96](index=96&type=chunk) - The company has a 10-year CEO Performance Award of up to **13 million shares** tied to market capitalization milestones. Stock-based compensation expense for this award was **$1.8 million** in Q1 2023[98](index=98&type=chunk)[103](index=103&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=28&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) MD&A highlights a **7% revenue decrease** to **$6.5 million** in Q1 2023, lower gross margin, and **$26.8 million** liquidity [Results of Operations](index=33&type=section&id=Results%20of%20Operations) Q1 2023 revenue decreased **7%** to **$6.5 million**, driven by lower disposables and service revenue, with gross margin at **59%** Revenue Comparison (in millions) | Revenue Stream | Q1 2023 (USD) | Q1 2022 (USD) | Change | | :--- | :--- | :--- | :--- | | Systems | $1.8 | $1.6 | +12.5% | | Disposables, service, and accessories | $4.7 | $5.4 | -13.0% | | **Total Revenue** | **$6.5** | **$7.0** | **-7.0%** | - The decrease in disposables, service, and accessories revenue was primarily driven by lower royalties from Biosense Webster[151](index=151&type=chunk) - Gross margin decreased to **59%** in Q1 2023 from **70%** in Q1 2022, driven by changes in system product mix and increased costs under service contracts[152](index=152&type=chunk) - Operating expenses increased, with R&D up **12%** due to project timing and regulatory expenses, and Sales & Marketing up **7%** from higher travel and stock-based compensation[153](index=153&type=chunk)[154](index=154&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) The company maintains strong liquidity with **$6.8 million** in cash and **$20.0 million** in short-term investments, holding no debt Liquidity Position (in millions) | Metric | March 31, 2023 (USD) | December 31, 2022 (USD) | | :--- | :--- | :--- | | Cash, cash equivalents, and restricted cash | $6.8 | $9.9 | | Short-term investments | $20.0 | $19.8 | | Working Capital | $26.6 | $29.0 | - Net cash used in operating activities increased to **$2.8 million** in Q1 2023 from **$2.2 million** in Q1 2022, driven by a higher operating loss[159](index=159&type=chunk) - The company had no debt as of March 31, 2023[162](index=162&type=chunk) [Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of March 31, 2023, with no material internal control changes - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of March 31, 2023[165](index=165&type=chunk) - No material changes to the company's internal control over financial reporting were identified during the first quarter of 2023[166](index=166&type=chunk) Part II Other Information [Legal Proceedings](index=36&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no material legal proceedings during the period - The company reports no material legal proceedings[168](index=168&type=chunk) [Risk Factors](index=36&type=section&id=Item%201A.%20Risk%20Factors) Updated risk factors highlight exposure to uninsured cash balances, with minimal impact from the SVB failure - The company highlights the risk of maintaining cash balances in excess of FDIC-insured limits at financial institutions[169](index=169&type=chunk) - Following the failure of Silicon Valley Bank (SVB), the company stated its cash balance at SVB was less than **6%** of its total cash and investments and it does not believe it has exposure to loss[169](index=169&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=36&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities were reported during the period - None reported[170](index=170&type=chunk)
Stereotaxis(STXS) - 2023 Q1 - Earnings Call Transcript
2023-05-09 21:58
Stereotaxis, Inc. (NYSE:STXS) Q1 2023 Earnings Conference Call May 9, 2023 10:00 AM ET Company Participants David Fischel - CEO & Chairman Kimberly Peery - CFO & Secretary Conference Call Participants Joshua Jennings - TD Cowen Frank Takkinen - Lake Street Capital Markets Alexander Nowak - Craig-Hallum Capital Group Neil Chatterji - B. Riley Securities Adam Maeder - Piper Sandler Operator Good morning. Thank you for joining us for Stereotaxis' First Quarter 2023 Earnings Conference Call. Certain statements ...
Stereotaxis(STXS) - 2022 Q4 - Annual Report
2023-03-09 20:38
Financial Performance - As of December 31, 2022, the company had a backlog of approximately $14.8 million, with an expectation that about 89% will be recognized as revenue in 2023[28]. - Revenue from disposable products is recognized upon shipment, with warranty costs being immaterial for the reported periods[42]. - Royalty revenue from co-developed catheters represented 7% of total revenue for the years ended December 31, 2022 and 2021[64]. Clinical Focus and Market Potential - The primary clinical focus is on electrophysiology, specifically cardiac ablation procedures, which represent a multi-billion-dollar market with significant long-term growth potential[19]. - Approximately 5,000 interventional labs conduct over one million cardiac ablation procedures annually, with a market growth rate of about 10% per year[53]. - The company estimates that 10-15% of interventional cardiology procedures are complex, which require longer times and may yield sub-optimal outcomes[58]. Product Development and Technology - The Genesis RMN System and Odyssey Solution are designed to improve procedure efficiency and reduce x-ray exposure, enhancing patient and physician safety[22][23]. - The Odyssey Solution integrates multiple sources of diagnostic and imaging information into a single user interface, improving clinical workflow and information management[34]. - The robotic magnetic navigation systems allow for precise control of interventional devices, which can enhance patient outcomes and expand the market for minimally invasive procedures[36]. - The Cardiodrive Automated Catheter Advancement System aims to enhance hospital efficiency by reducing procedure times and disposable utilization, particularly in complex procedures like ventricular tachycardia[39]. - The Odyssey Solution provides a fully integrated, real-time information system that improves physician workflow in interventional labs, allowing control of multiple systems from a single interface[40]. - The Stereotaxis Imaging Model S X-ray System is designed to minimize radiation exposure while providing high-quality imaging, thus reducing the cost of robotic electrophysiology practices[41]. - The company has developed a toolkit of disposable interventional devices that complement its robotic navigation systems, enhancing procedural efficiency[43]. Regulatory and Compliance - The company has received regulatory clearances for its products in the U.S. and Europe, including the Genesis RMN System and Stereotaxis Imaging Model S x-ray System[26]. - The company has received regulatory approvals for multiple systems, including the Genesis RMN System and the Niobe System, across various regions including the U.S., Europe, and China[45][46]. - The FDA's 510(k) clearance process typically takes from four to 12 months, while the PMA process can take from one to three years or longer, making it a more costly and uncertain pathway[101]. - The company must comply with the Quality System Regulation (QSR) and other regulatory requirements, which include stringent design, testing, and documentation procedures during product design and manufacturing[103]. - The company is subject to various federal and state laws relating to healthcare fraud and abuse, including anti-kickback and false claims laws, which impose significant penalties for violations[110]. - The company is subject to the California Consumer Privacy Act (CCPA), which imposes significant compliance burdens and potential fines for violations[116]. - The company must obtain a certificate of need in several states before acquiring high-cost capital items, impacting the purchase orders for its robotic magnetic navigation systems[118]. Strategic Relationships and Collaborations - The company has strategic relationships with technology leaders to ensure compatibility between its systems and other medical technologies, critical for commercialization efforts[30]. - Strategic relationships with technology leaders in the interventional market enhance the commercialization of the robotic magnetic navigation system[60]. - The company has entered into a strategic collaboration with Osypka AG for the development of a next-generation magnetic ablation catheter, with Stereotaxis funding the development and retaining sole ownership[65]. Workforce and Culture - The company employs a diverse workforce across 11 countries, emphasizing the importance of attracting and retaining top talent in the competitive medical device industry[122]. - The company is committed to diversity, equity, and inclusion, fostering a workplace culture that values mutual respect and inclusive behavior[123]. - The company provides a comprehensive total rewards package, including base compensation, annual bonuses, healthcare benefits, and opportunities for equity ownership through stock options[127]. - As of December 31, 2022, the company had 130 employees, with 37 in research and development, 58 in sales and marketing, 16 in manufacturing and service, and 19 in general administrative activities[120]. Manufacturing and Quality Control - The company’s manufacturing strategy includes subcontracting major subassemblies to maximize flexibility and lower fixed costs, while maintaining quality control through in-house assembly[72]. - The company’s manufacturing facility has been audited annually since 2001 and is compliant with FDA requirements and ISO standards[77]. Sales and Market Dynamics - The sales cycle for the robotic magnetic navigation system is lengthy, often involving construction or renovation at customer sites, leading to significant revenue variability[28]. - The company faces competition from traditional catheter-based electrophysiology approaches and emerging robotic technologies in the medical device market[90][93]. Research and Development - The company’s research and development team collaborates with strategic third parties and leading interventional physicians to enhance its product offerings[68]. - The company maintains a focus on integrating its robotic magnetic navigation system with key imaging and location sensing systems in interventional labs[68]. - The company has 50 issued U.S. patents and 2 pending U.S. patent applications as of December 31, 2022, with key patents extending until 2028 and beyond[84].
Stereotaxis(STXS) - 2022 Q4 - Earnings Call Transcript
2023-03-03 18:37
Financial Data and Key Metrics Changes - Revenue for the fourth quarter of 2022 totaled $7.3 million, down from $8.2 million in the prior year fourth quarter. Full year revenue was $28.1 million compared to $35 million in 2021 [45][47] - System revenue for the full year 2022 was $6.8 million, compared to $11.2 million in the prior year, impacted by hospital construction delays [45][47] - Recurring revenue for the full year was $21.3 million, down from $22.9 million, reflecting procedure volatility and service renewal timing [20][47] - Operating loss for the fourth quarter was $4.5 million, compared to approximately $3.4 million for the previous year [21][47] - Adjusted operating loss for the full year 2022 was $8.3 million, compared to $3.6 million in the prior year [47] Business Line Data and Key Metrics Changes - The company reported a system backlog of $14.8 million at the start of 2023, indicating potential revenue recognition from this backlog [18][43] - Gross margin for the fourth quarter and full year 2022 were approximately 59% and 66% of revenue, respectively [20][45] - System gross margins reflect significant allocations of fixed overhead expenses, with full year gross margins of 82% on recurring revenue and 15% for system revenue [20][47] Market Data and Key Metrics Changes - Approximately 40% of procedure volume comes from Europe, with significant interest in the upcoming MAGiC catheter launch [30][34] - The company expects to see a recovery in procedures in China as COVID restrictions ease, which should positively impact recurring revenue [65] Company Strategy and Development Direction - The company aims to transform endovascular surgery with robotics, addressing limitations of manual handheld catheters [8][9] - Key innovations include the MAGiC catheter, a smaller self-shielding robot, and a family of interventional guidewires and catheters, which are expected to drive growth [13][40] - The company is focused on building a robust sales team and improving its capital sales strategy to enhance market penetration [100] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving double-digit revenue growth in 2023, driven by backlog revenue recognition and new system orders [18][23] - The company anticipates that the launch of new products will significantly accelerate both system and recurring revenue adoption in the coming years [23][88] - Management acknowledged the challenges posed by hospital construction delays and the need for improved customer urgency in the sales process [72][93] Other Important Information - The company moved into a new custom-built headquarters and manufacturing facility, which is expected to enhance operations and support future growth [42][44] - The company has approximately $30 million in cash and no debt, providing a strong balance sheet to support its strategic initiatives [44][49] Q&A Session Summary Question: What is the expected adoption of the MAGiC catheter in Europe? - Management noted strong excitement among physicians for the MAGiC catheter, with plans for a limited market release to ensure a smooth launch [26][53] Question: What are the expectations for system revenue growth in 2023? - Management expects system revenue to grow due to recognizing the majority of the backlog and increased orders compared to 2022 [71][78] Question: How does the company plan to address the sales cycle challenges? - Management highlighted the importance of building a robust capital sales team and improving customer engagement to drive urgency in the sales process [100][105]