David Fischel
Analyst · Cowen
Thank you, operator, and good morning, everyone. I'm joined today by Kim Peery, our Chief Financial Officer. My prepared remarks today will be a bit longer than normal. I want to use the occasion of this being our annual call to provide a broader overview of Stereotaxis, our vision and our goals. I’ll then review our accomplishments in 2019 and our focus and expectations for 2020. Stereotaxis is the global pioneer and leader of robotics for endovascular surgery. We have developed a highly innovative suite of robotic technologies that address the inherent limitations, risks and challenges posed by manual catheters. Endovascular surgery is a broad class of procedures, where a catheter is inserted into a blood vessel navigated through the vascular system to an area of interest and then use to deliver therapy. It has emerged in recent decades as the least invasive surgical option to treat a wide variety of conditions and has blossomed with many millions of catheter based surgeries performed annually. While manual handheld catheters are a testament to human ingenuity, their mechanism of action has fundamental flaws. During the procedure, therapy takes place at the catheter tip, but a manual catheter is held and manipulated by a physician's hand several feet away from the catheter handle. Using a manual catheter can be compared to writing in small font while holding a pencil from its eraser or watering plants while holding on to a gardening hose several feet back from the end. The mechanism leads to limited catheter precision, limited catheter stability and limited catheter reach. Since manual catheters need to be rigid to allow for physician control to reach the tip. There's increased risk of patient injury. Procedures are complex and operator dependent and visualization of a catheter requires X-ray exposing patients and physicians to radiation. Stereotaxis’ robotic platform is designed to address these inherent limitations, risks and challenges. It fundamentally transforms and improves catheter navigation by allowing for control of a catheter directly from the tip using precise computer controlled magnetic fields. The magnetic fields can be viewed as invisible tweezers, holding on to the catheter tip. Direct control of the tip leads to unprecedented precision and stability. It enables reaching areas unreachable by manual catheters. Since a robotic magnetic catheter does not require shaft rigidity, it can be designed to be gentle, increasing patient safety. Physicians operate with our robot from a computer cockpit seated and fully protected from radiation with full control over the procedure at their fingertips and within our ability to focus on the cognitive aspect of their profession, rather than the mechanical effort of manipulating a catheter. Our technology is a platform technology. And the benefits of robotic precision and safety are applicable across a broad spectrum of endovascular catheter based procedures. While, we have begun efforts to address various clinical applications, our primary focus is on one specific endovascular procedure, cardiac ablation for the treatment of arrhythmias. Arrhythmias are a common condition where the heartbeats are regularly. In a cardiac ablation procedure, a catheter is navigated into a patient's heart and used to deliver a blade of energy that stops rogue electrical impulses causing the arrhythmia. Cardiac ablation has become a widely accepted therapy over the last two decades, with over 1 million procedures performed annually, and over $4 billion in annual medical device sales. The benefits of robotic magnetic navigation, precision, stability, reach and safety are pronounced in cardiac ablation procedures. They are also not theoretical as there's extensive clinical and real world validation. Nearly 400 scientific publications, document the clinical benefits of Stereotaxis robotic technology. Stereotaxis’ website includes a searchable database of all of these publications, as well as the comprehensive analysis of head-to-head robotic versus manual studies that show dramatic improvements in patient outcomes, both safety and efficacy. Our clinical value is validated everyday in real world usage globally. Hundreds of physicians at over 100 leading hospitals have treated over 100,000 patients with our technology. On our website, we have testimonials from dozens of these physicians describing why they use robotics and the array of benefits it provides them, their patients and their practice. I have full confidence that Stereotaxis’ robotic technology and the robotic magnetic mechanism of action is the best way to treat patients and to address the inherent limitations and risks of manual endovascular surgery. Stereotaxis’ vision is to positively transform endovascular surgery with robotics in a similar fashion to have intuitive surgical transformed laparoscopic surgery. Cardiac ablation is our beachhead, and we will grow from there. Despite the significant benefits of our technology, our beachhead in cardiac ablation is still small. We have less than 1% market share in the cardiac ablation market, lead alone endovascular surgery more broadly. When I joined Stereotaxis three years ago, I recognized that it was a company with significant technological and clinical advantages, but also significant challenges. Initial missteps within an aggressive premature commercialization, poor allocation of financial and human resources, limited engagement with partners and potential partners in the industry, and the lack of a clear innovation and commercial strategy that Stereotaxis is in need of a turnaround. 2019 was a transformative year for Stereotaxis with significant progress across multiple fronts to bring about this turnaround. Our accomplishments can be measured in several key categories. First, financial. Stereotaxis starts 2020 in a position of financial strength. We have $30 million in cash and no debt on our balance sheet. We are investing in the drivers of long-term growth, while remaining prudent with shareholder capital, such that our existing balance sheet comfortably allows us to reach consistent, meaningful profitability. Our 2019 cash use of $4.6 million was entirely driven by incremental investments in R&D, and in working capital as we build inventory for commercialization of our novel Genesis robotic system. We are proud that in 2019, we were able to up-list onto the New York Stock Exchange and to attract high quality healthcare focused institutional firms to join us as investors. Second, commercial infrastructure. Stereotaxis’ commercial focus has been to develop the infrastructure and processes that ensure robotic practices are successful can grow and can showcase their clinical and technological leadership in their communities. This is a multifaceted effort, including having a world class clinical field team, enhancing our remote telemedicine support capability, developing training simulators, partnering with the physician led society for cardiac robotic navigation, supporting impactful clinical literature, establishing the Robotic EP Fellowship Program and providing customers with a marketing toolkit they can use to educate patients and referral physician. I'm proud of the infrastructure we have built and our early efforts to implement these capabilities. In 2019, we were delighted to celebrate the first graduating class of 13 robotic electrophysiology fellows. These fellows are the future leaders in electrophysiology and our engagement and support as they start their careers helps ensure that a new generation of physicians is confident in our technology and its clinical value. The Fellowship Program has grown to include over 40 fellows currently enrolled at over 20 hospitals globally. The quantity and quality of clinical literature also continues to grow, with 34 peer-reviewed publications in 2019, along with the initiation of a study for a cardiac ablation, initiation of two registries and continued enrollment in our randomized multicenter study to demonstrate superiority of robotics for ventricular tachycardia. We believe the MAGNETIC-VT trial can complete enrollment and report one year outcome data in the 2021, 2022 timeframe. As we enter a phase of renewed robotic system sales, Stereotaxis is incrementally investing, experimenting and establishing capabilities that will allow for a robust capital sales pipeline. We are building this capability in a methodical fashion along with the build-up of our supply chain and in a way that is prudent and sustainable. We are excited by the positive impact of resurgence and system sales will have for Stereotaxis, but also remain cognizant that ensuring the success of robotic practices is the best strategy for increased adoption of robotic systems and for enhancing long-term business value. We will continue to advance our commercial capabilities accordingly. The highlight of the past year with the significant progress made in our innovation and collaboration strategy. The Genesis Robotic system was the first meaningful leap forward in robotic magnetic navigation technology since the original launch of the Niobe system over 15 years ago. Feedback from dozens of physicians that have visited Stereotaxis to take Genesis for a test drive reinforce our confidence that the instantaneous responsiveness, reduced footprint and enhanced architecture will meaningfully improve the physician experience and lab efficiency. Combining Genesis with a tightly integrated proprietary fluoroscope was a novel strategy that allowed us to enhance the accessibility and affordability of a robotic lab, while making the [technical difficulty] servicing more customer friendly. On our last quarterly call, I described three main efforts related to Genesis. The regulatory process, supply chain optimization and engagement with customers. We were delighted last week to receive FDA clearance for Genesis. I want to congratulate the Stereotaxis team for this significant milestone, and thank to FDA for their diligent review and constructive engagement. On the supply chain, we continue to make good progress in building inventory and ensuring all our key suppliers have robust capacity to deliver sufficient quantity of components in a timely fashion. This is a continuous effort, but I'm pleased with how we are progressing. Commercially in Europe, we have begun -- we have been engaging with existing customers on replacement projects, and with new potential customers on building robotic EP labs. With last week's FDA clearance, we're now beginning to do the same in the U.S. I'm excited that in the past two months since the start of this year, we have received purchase orders for two robotic systems, one to a hospital that establishing a new robotic electrophysiology practice and one replacement system at an existing customer. We anticipate these systems being delivered to the customers and recognize this revenue in the second or third quarters of this year. While the purchase process for a robot is lengthy, involving multiple layers of hospital approval, extensive contracts, [often] the tender process and the coordination of construction schedules. I am pleased with activity taking place at multiple hospitals. The return to consistent and robust robotic system sales may not be linear, and it is very much real and starting. In 2019, we were also excited to announce multiple collaborations related to mapping technologies. Mapping technologies play a crucial role in cardiac ablation procedures by providing patient specific diagnostic information to guide therapy. The development of our OpenMapping software architecture to support broad mapping integration was an important step in creating a healthier ecosystem around robotics. Open ecosystems that support physician choice are ultimately best for patient care, for physicians, for providers and for overall progress. We were delighted to announce successful mapping integration with Acutus Medical, an exciting private company based in San Diego that has developed the highly innovative and differentiated mapping system. Our first integrated procedures have been well received, and we have multiple joint customers that are starting to adopt the two systems together. Late in 2019, we added to this ecosystem with successful integrations and procedures with pre-innovative, preoperative mapping technologies from inHEART, ADAS 3D and VIVO. The last significant strategic innovation announced in 2019 is our collaboration with Osypka to develop a proprietary next generation magnetic ablation catheter. The catheter is being designed to meaningfully improve patient care and the physician experience, but also serves to significantly improve Stereotaxis’ financial and strategic positioning. We expect the catheter to serve as the driver of a second more substantial wave of revenue growth on the heels of Genesis. Development of the catheter is advancing well. We were excited in February to successfully complete the first animal studies with prototypes of the catheter. We also had the benefit of being able to share the catheter with several sophisticated electrophysiologist and receive their feedback. We are very pleased with where we stand and making various small refinements to the catheter design to further optimize performance and anticipate finalizing the design in the near-term. We are proud of our robust investment in innovation and the impact that innovation will have on patients on our customers and on Stereotaxis. We're also cognizant that the technologies we have announced represent just the initial forays into what we can do. All of our technologies can be improved further, and we will improve them in the coming years. For various reasons it is prudent to own -- to advance R&D in a methodical fashion and to disclose new technologies only when relevant. We believe this is the right thing for long-term shareholder value. We've provided insight into our innovation strategy and focused on our most updated investor presentation available on our website. Kim will now discuss our financial results in more detail and then I'll make a few financial comments before opening the call to Q&A.