Stereotaxis(STXS)
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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]
Stereotaxis(STXS) - 2021 Q3 - Quarterly Report
2021-11-12 14:05
[Part I Financial Information](index=4&type=section&id=Part%20I%20Financial%20Information) [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents Stereotaxis, Inc.'s unaudited consolidated financial statements for Q3 and nine months ended September 30, 2021, detailing financial position, operations, equity, and cash flows [Balance Sheets](index=4&type=section&id=Balance%20Sheets) Total assets increased to **$61.9 million** by September 30, 2021, driven by new lease assets, while cash decreased slightly to **$40.2 million** Balance Sheet Summary (as of September 30, 2021 vs. December 31, 2020) | Metric | Sep 30, 2021 (USD) | Dec 31, 2020 (USD) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $40,243,223 | $43,939,512 | | Total current assets | $53,410,612 | $52,716,739 | | Total assets | $61,920,294 | $55,455,825 | | **Liabilities & Equity** | | | | Total current liabilities | $13,842,468 | $13,573,186 | | Total liabilities | $21,763,384 | $15,226,584 | | Total stockholders' equity | $34,573,142 | $34,623,918 | [Statements of Operations](index=5&type=section&id=Statements%20of%20Operations) Q3 2021 revenue grew to **$9.1 million**, but net loss widened to **$4.6 million** due to increased G&A expenses, while nine-month revenue rose **35%** Statement of Operations Highlights | Metric | Q3 2021 (USD) | Q3 2020 (USD) | Nine Months 2021 (USD) | Nine Months 2020 (USD) | | :--- | :--- | :--- | :--- | :--- | | Total Revenue | $9,106,452 | $8,703,583 | $26,780,432 | $19,805,279 | | Gross Margin | $4,734,558 | $4,678,328 | $17,282,448 | $13,743,628 | | Operating Loss | $(4,619,817) | $(1,563,039) | $(9,538,660) | $(5,537,205) | | Net Loss | $(4,618,559) | $(1,572,972) | $(7,361,354) | $(5,465,609) | | Net Loss per Share (Basic) | $(0.07) | $(0.03) | $(0.11) | $(0.09) | - A significant factor in the increased net loss was a gain on extinguishment of debt of **$2.2 million** recognized in the first nine months of 2021, related to the forgiveness of the PPP loan[14](index=14&type=chunk) [Statements of Convertible Preferred Stock and Stockholders' Equity](index=6&type=section&id=Statements%20of%20Convertible%20Preferred%20Stock%20and%20Stockholders'%20Equity) Stockholders' equity remained stable at **$34.6 million** as of September 30, 2021, with net loss offset by **$6.8 million** in share-based compensation - For the nine months ended September 30, 2021, the net loss of **$7.4 million** was the primary driver of the decrease in accumulated deficit, which was partially offset by share-based compensation of **$6.8 million**[21](index=21&type=chunk) [Statements of Cash Flows](index=8&type=section&id=Statements%20of%20Cash%20Flows) Net cash used in operating activities improved to **$0.9 million** for the first nine months of 2021, with total cash and equivalents at **$42.5 million** Cash Flow Summary (Nine Months Ended September 30) | Cash Flow Activity | 2021 (USD) | 2020 (USD) | | :--- | :--- | :--- | | Net cash used in operating activities | $(889,992) | $(3,819,735) | | Net cash used in investing activities | $(1,037,649) | $(70,896) | | Net cash provided by financing activities | $535,683 | $17,304,345 | | **Net (decrease) increase in cash** | **$(1,391,958)** | **$13,413,714** | [Notes to Financial Statements](index=9&type=section&id=Notes%20to%20Financial%20Statements) Notes detail accounting policies, business operations in robotic navigation, revenue recognition, a new 10-year lease, **$2.2 million** PPP loan forgiveness, and significant CEO performance award compensation - The company designs, manufactures, and markets advanced **robotic magnetic navigation (RMN) systems**, including the Genesis RMN and Niobe Systems, for use in interventional procedures to treat arrhythmias[27](index=27&type=chunk)[28](index=28&type=chunk) - In June 2021, the company's **$2.2 million** Paycheck Protection Program (PPP) loan was fully forgiven by the SBA, resulting in a gain on debt extinguishment[91](index=91&type=chunk) - A new 10-year performance award for the CEO, tied to market capitalization milestones, resulted in **$4.3 million** of stock-based compensation expense for the nine-month period ended September 30, 2021[97](index=97&type=chunk)[101](index=101&type=chunk) - The company entered into a new 10-year lease for its principal executive offices and manufacturing facility, recognizing a **$5.9 million** right-of-use asset and lease liability in Q3 2021[81](index=81&type=chunk)[82](index=82&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses **35%** revenue growth for the first nine months of 2021, increased operating expenses due to CEO performance award compensation, and a strong liquidity position with **$42.8 million** cash [Results of Operations](index=34&type=section&id=Results%20of%20Operations) Nine-month revenue grew **35%** to **$26.8 million** driven by system sales, but operating loss increased due to **108%** rise in G&A expenses from CEO performance award compensation Comparison of Nine Months Ended September 30, 2021 and 2020 | Metric | 9M 2021 (USD) | 9M 2020 (USD) | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Total Revenue | $26.8 million | $19.8 million | +35% | Increased system sales | | Gross Margin % | 65% | 69% | -4 p.p. | Changes in product mix | | R&D Expenses | $7.6 million | $6.0 million | +26% | Higher project spending and hiring | | G&A Expenses | $10.3 million | $5.0 million | +108% | Higher stock-based compensation for CEO Performance Award and professional fees | - For Q3 2021, revenue increased **5%** year-over-year to **$9.1 million**, while G&A expenses surged **169%** to **$3.9 million**, primarily due to stock-based compensation for the CEO Performance Award[160](index=160&type=chunk)[164](index=164&type=chunk) [Liquidity and Capital Resources](index=38&type=section&id=Liquidity%20and%20Capital%20Resources) The company maintains a strong liquidity position with **$42.8 million** in cash and no debt, and net cash used in operations improved to **$0.9 million** - As of September 30, 2021, the company had **$42.8 million** in cash and cash equivalents (inclusive of restricted cash) and no debt[173](index=173&type=chunk)[176](index=176&type=chunk) - Net cash used in operating activities for the first nine months of 2021 improved to **$0.9 million** from **$3.8 million** in the same period of 2020[173](index=173&type=chunk) - The company's **$2.2 million** Paycheck Protection Program (PPP) loan was fully forgiven by the SBA in June 2021, resulting in a gain on debt extinguishment[178](index=178&type=chunk) [Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and procedures were effective, with no material changes to internal control over financial reporting identified - Based on an evaluation as of the end of the period covered by this report, the CEO and CFO concluded that the company's disclosure controls and procedures were **effective**[185](index=185&type=chunk) - There were **no material changes** during the quarter that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[186](index=186&type=chunk)[187](index=187&type=chunk) [Part II Other Information](index=41&type=section&id=Part%20II%20Other%20Information) [Legal Proceedings](index=41&type=section&id=Item%201.%20Legal%20Proceedings) A class action complaint regarding CEO Performance Award disclosure deficiencies was settled for **$675,000** in attorneys' fees without admission of wrongdoing - A putative **class action complaint** was filed on April 29, 2021, alleging **disclosure deficiencies** in the proxy statement concerning the CEO Performance Award[190](index=190&type=chunk) - The company agreed to pay **$675,000** to the plaintiff's counsel for attorneys' fees and expenses to achieve a full satisfaction of the claims[193](index=193&type=chunk) [Risk Factors](index=41&type=section&id=Item%201A.%20Risk%20Factors) Updated risk factors highlight significant stock-based compensation expense, potential stockholder dilution, and disincentives for change in control related to the CEO Performance Award - The company will incur **significant stock-based compensation expense** over the term of the CEO Performance Award, regardless of whether performance milestones are met. As of September 30, 2021, approximately **$53.1 million** of expense remained to be recognized[195](index=195&type=chunk) - Stockholders may face **substantial dilution** if all **13,000,000 shares** under the CEO Performance Award are issued upon achievement of all milestones[196](index=196&type=chunk) - Provisions in the award agreement related to a change in control could **discourage potential mergers or acquisitions** that might otherwise be beneficial to stockholders[198](index=198&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=43&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the reporting period - There were **no unregistered sales** of equity securities during the reporting period[200](index=200&type=chunk) [Exhibits](index=43&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate governance documents and Sarbanes-Oxley Act certifications - The report includes a list of filed exhibits, such as the **Restated Articles of Incorporation**, **Bylaws**, and **certifications by the CEO and CFO** pursuant to the Sarbanes-Oxley Act of 2002[204](index=204&type=chunk)[205](index=205&type=chunk)
Stereotaxis(STXS) - 2021 Q3 - Earnings Call Transcript
2021-11-11 19:25
Stereotaxis, Inc. (NYSE:STXS) Q3 2021 Earnings Conference Call November 11, 2021 10:00 AM ET Company Participants David Fischel - Chairman and CEO Kim Peery - CFO Conference Call Participants Josh Jennings - Cowen Adam Maeder - Piper Sandler Frank Takkinen - Lake Street Capital Markets Javier Fonseca - Spartan Capital Guy Judkowski - Pufferfish Capital Operator Good morning. Thank you for joining us for Stereotaxis Third Quarter 2021 Earnings Conference Call. Certain statements during the conference call an ...