Aleks Cukic
Analyst · Morgan Stanley
Thank you, Marshall. During the fourth quarter, we sold 152 da Vinci systems; 113 in the United States, 23 into Europe and 16 into rest of world markets. As part of the 152 system sales, 23 standard da Vinci systems and 27 da Vinci S systems were traded in for credit against sales for new da Vinci Si systems. We had a net 101 system additions to the installed base during the quarter, which brings to 2,132 the cumulative number of da Vinci systems worldwide; 1,548 in the U.S., 372 in Europe and 212 in rest of world markets. 82 of the 152 systems installed during the quarter represented repeat system sales to existing customers. In total, 144 of the 152 systems sold represented da Vinci Si systems, which included 29 dual console systems. The 39 system sales internationally included 5 into Japan, 5 into France and 4 into the countries of Germany and Russia. As mentioned in the past, Q4 tends to provide seasonal strength for da Vinci system sales, most notably in the U.S. While international da Vinci sales were solid, the EU macroeconomic environment remained choppy. Clinically, we had a strong quarter, achieving an overall year-over-year procedure growth rate of approximately 27%. Gynecology and general surgery growth was particularly strong; while urology, most notably international dVP growth, was robust. Within GYN, strong growth took place across the board. The 9 dVH sacrocolpopexy, myomectomy and endometrial resections were up sharply. General surgery growth was also strong within several procedure subcategories, including G.I. surgery and cholecystectomy. During the quarter, nearly 300 abstracts and papers representing a variety of surgical specialties were published within various peer reviewed journals, while the clinical conferences were abundant with why da Vinci procedure transmissions, postgraduate robotic courses, podium presentations and clinical poster sessions. While our FDA clearance for Single-Site is brand-new, we've had the product selectively available in Europe for the past few quarters. The initial European response has been favorable with early clinical reports beginning to make their way into the clinical journals. In a recent edition of the journal, Surgical Endoscopy, Dr. Spinoglio and Lenti from Alessandria, Italy published a comparative analysis entitled, Single-Site Robotic Cholecystectomy Versus Single-Incision Lap Chole: A Comparison of Learning Curves. In the publication, they described how technical constraints, such as instrument collisions, lack of triangulation and cross-handing has hampered the SILS approach from fully emerging. They described how using a robotic platform may overcome these problems and enable more precise surgical actions by increasing freedom of movement and by restoring intuitive instrument control. In their study, performed under institutional controls, the surgeons compared the results of their first 25 Single-Site cases to their first 25 single-incision lap choles and followed up each patient 2 months postoperatively. The result showed consistency between the 2 patient groups when it came to wound complications where neither group experienced wound infections or incisional hernias. Length of hospitalization was reduced slightly within the Single-Site cohort. However, the most striking difference between the 2 groups was the operative time to perform the procedure. They published that the operative time was significantly reduced using Single-Site as compared to the manual single-incision approach. Average operative time was 83.2 minutes with the SILS approach compared to 62.7 minutes with Single-Site. Their conclusion was and I quote, "Our preliminary experience shows that Single-Site robotic chole is safe, can easily be learned and performed in a reproducible manner and is faster than single-incision lap chole." We continue to experience general surgery procedure strength across several subcategories, cholecystectomy among them. Going forward, we anticipate general surgery playing a more prominent role within our overall procedure mix. While not a primary target, the conversion from laparoscopic hysterectomy to dVH has been taking place within a number of practices. These conversions have not been isolated to any particular pathological segment, meaning that we have seen conversions take place within both benign and malignant treatment pathways. Surgeons have provided various reasons for converting lap cases to dVH, most of which relate to the expansion of MIS technique across a wider spectrum of patients. But a recent study published in the journal, Gynecologic Oncology, provides a new postoperative cost savings argument. The study authored by Drs. Martino and Shubella was entitled, A Cost Analysis of Postoperative Management in Endometrial Cancer Patients Treated by Robotics Versus Laparoscopic Approach. The study retrospectively collected cost data from 215 patients, 101 dVHs and 114 lap hyst patients where all surgeries were performed by gynecologic oncologists. Demographic data, patient recorded pain scores, pain management interventions and post operative pain medication costs were compared. They reported that robotic patients had a lower number of initial drug interventions as well as a lower number of total drug interventions than laparoscopic patients. Robotic patients also had a lower initial pain score. There was a 50% reduction in the pain medication cost on the day of surgery for robotic patients and a 56% cost reduction for the rest of their length of stay. The author's conclusion and I quote, "Endometrial cancer patients, who have robotic surgery experience, less initial postoperative pain and have fewer drug interventions, the cost associated for their pain management represents a savings of greater than 50%. These factors demonstrate the value of robotic surgery in regard to postoperative pain management by delivering higher-quality care at a lower cost." Drs. Magrina and Zanagnolo from the Mayo Clinic of Scottsdale published a study in the European Journal of Gynecologic Oncology entitled, Robotic Surgery for Endometrial Cancer: A Comparison of Perioperative Outcomes and Recurrences with Laparoscopy, Vaginal Laparoscopy and Laparotomy. The method of study was a prospective analysis of 67 patients undergoing robotic surgery for endometrial cancer as compared to 37 laparoscopic hysterectomies, 99 laparotomy approaches and 47 vaginal laparoscopic combination procedures. They reported that the mean operating times for patients undergoing these 4 techniques was pretty similar. But mean blood loss differed significantly; 141 milliliters for robotic patients, 300 milliliters for lap patients, 300 milliliters for vag lap patients and 472 milliliters for open laparotomy. The mean length of hospital stay was 1.9 days in the robotic cohort, 3.4 days for lap patients, 3.5 days for vaginal lap patients and 5.6 days for their laparotomy patients. There were no significant differences in intra or postoperative complications among the 4 groups. The conversion rate was 2.9% for robotics compared to 10.8% for the laparoscopy group. Their conclusion and I quote, "Robotics, laparoscopy and vaginal laparoscopy techniques are preferable to laparotomy for suitable patients with endometrial cancer. Robotics is preferable to laparoscopy due to a shorter hospital stay and lower conversion rate and preferable to vaginal laparoscopy due to reduced hospitalization." Late adopters of urologic robotic surgery have, from time to time, issued critiques based purely on a structural academic point of view, citing little prospective randomized data comparing dVP to open prostatectomy. And since powering a large study with enough men willing to be randomized into the open surgery cohort is both difficult and unlikely, we have relied on the large body of clinical evidence that has been drawn from quality institutions around the world. This month, 2 more very large studies were published in the journal, European Urology. Each study was comprised of 5-digit national samples, but for sake of time, I'll highlight only one. The study was entitled, Perioperative Outcomes of Robotic-Assisted Radical Prostatectomy Compared with Open Radical Prostatectomy: Results from an Inpatient Sample. It originated out of the Vattikuti Urology Institute at Henry Ford Hospital in Detroit and included authorship support from several other leading centers. The study, which included over 19,000 prostatectomy patients, compared the rates of blood transfusions, intraoperative and postoperative complications, prolonged length of stay and in-hospital mortality between 7,400 open prostatectomies and 11,900 dVP patients. In the comparison, the authors reported that the percentage of men requiring blood transfusions was approximately 3.5x greater for men undergoing an open prostatectomy as compared to dVP. The percentage of men experiencing intraoperative complications was over 2x greater for open prostatectomy. Postoperative complications were approximately 25% higher in the open prostatectomy group. Length of stay, prolonged length of stay and in-hospital mortality was found to be higher within the open prostatectomy group. The authors summarized their conclusion by stating and I quote, "Robotic-assisted radical prostatectomy has supplanted open prostatectomy as the most common surgical approach for radical prostatectomy. Moreover, we demonstrate superior adjusted perioperative outcomes after robotic-assisted radical prostatectomy in virtually all examined outcomes." This concludes my remarks, so I'll now turn the time over to Calvin.