Aleks Cukic
Analyst · ThinkEquity
Thank you, Marshall. During the first quarter, we sold 140 da Vinci systems: 105 in the United States, 14 into Europe and 21 into rest of world markets. As part of the 140 system sales, 19 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 94 system additions to the installed base during the quarter, which brings to 2,226 the accumulative number of da Vinci systems worldwide, 1,615 in the United States, 379 in Europe and 232 in rest of world markets. 80 of the 140 systems installed during the quarter represented repeat system sales to existing customers. In total, 132 of the 140 systems sold represented da Vinci Si systems, which included 25 dual console systems. The 35 system sales internationally included 7 into Japan, 4 into India and 3 into the countries of Italy, the U.K. and Australia. While our overall international system sales were strong, our Q1 EU system sales were somewhat disappointing and below historical trends. Clinically, we had a strong quarter, achieving an overall year-over-year procedure growth rate of approximately 29%. Gynecology, international dVP, along with the emerging categories of general surgery and thoracic surgery, accounted for a large part of this growth. Cholecystectomy, colon and rectal resections, lobectomy, dVH, endometriosis resections, myomectomy and partial nephrectomy all exhibited strong year-over-year growth. International dVP growth remained strong both in Europe and rest of world. However,, in the U.S., dVP has felt some recent pressure from non-surgical disease management, mainly active surveillance. With the international market playing an every ever-increasing role in the worldwide procedure numbers, overall worldwide dVP growth remains positive. Recent new product launches are all proceeding well. The attachment rate for both the da Vinci simulator and our Firefly product remain high, which is helping to buoy da Vinci system ASPs. The initial customer response to our da Vinci Single-Site product line has been very positive, with many centers up and running and several more scheduled for training. We initiated a phased rollout of the vessel sealer product in the second half of the quarter, and early customers are beginning to perform their initial cases. The product is performing well and early customer feedback has been positive. But as with all new product launches, customer feedback processes and operational scaling will remain central themes. Throughout this period, the focus of our operations team will be to optimize manufacturing while reducing cost. During the quarter, over 350 abstracts and papers representing a variety of surgical specialties were published within various peer review journals, while the clinical conferences were abundant with live da Vinci procedure transmissions, post-graduate robotic courses, podium presentations and clinical poster sessions. As we've discussed, da Vinci colon and rectal surgery is an emerging category and is receiving a lot of clinical interest and for good reason. While clinical experiences for laparoscopic colon and rectal surgery date back to 1991, the adoption has been lagging. In a recent edition of the American Surgeon, Dr. Joseph Carmichael and his colleagues from the University of California Irvine published a comprehensive review on the utilization of laparoscopy in colorectal surgery for cancer in academic medical centers. In it, they segment various colorectal surgical procedures as they relate to laparoscopic adoption. University Hospital Consortium or UHC is a large organization consisting of 112 academic medical centers and their affiliates, representing approximately 90% of the nation's non-profit academic medical centers. The study, based on data from the UHC database, included records from 22,780 patients who had undergone open or laparoscopic colon and rectal surgery for cancer between 2007 and 2009. Interestingly, 19,408 or over 85% of these patients received an open surgery as compared to 3,372 or 14.8% who had received a laparoscopic procedure. The study reports that, as a percentage, the most commonly performed laparoscopic colon resection was a total colectomy at 22.6%, followed by a sigmoid resection at 17.3%. The least common were abdominoperineal resections at 8%, transverse colon resections at 10%. When subcategories were consolidated and analyzed, it was reported that laparoscopic surgery was incorporated in less than 20% of colon cancer resections and less than 10% of rectal cancer resections. Historically, both patient value and da Vinci's procedure adoption have been strongest where a traditional lap in MIS adoption has been limited. This is often the case within procedure categories where MIS is deemed clinically challenging. While every procedure has its own set of variables, prostatectomy, complex hysterectomy, partial nephrectomy, myomectomy, sacrocolpopexy and lobectomy have shared at least one common bond, which is that, each of them, despite years of clinical effort, was limited to a relatively small number of centers, resulting in limited MIS penetration. We believe that MIS colorectal surgery is consistent with this theme. While laparoscopic colorectal surgery is limited in the U.S., lap colon initiatives throughout Korean and Japanese universities have been more ambitious, which has led to some academic analysis of da Vinci's role versus laparoscopy. A comparative study of urinary voiding and sexual function following a total mesorectal excision or TME for rectal cancer was recently published in the Annals of Surgical Oncology. The study, authored by Dr. Young-Joon Kim and his colleagues from Yonsei University, compared laparoscopic and robotic TME as it relates to complications in urinary incontinence and sexual function, which are both common complications in rectal cancer surgery. 69 patients who underwent a lap or robotic procedure were prospectively enrolled. Their urogenital function was evaluated by uroflowmetry. Standard questionnaires to establish an international prostate symptom score and international index of erectile function score were given before surgery and at 1, 3, 6 and 12 months post surgery. Their initial findings were not surprising in that bladder function within both cohorts significantly decreased 1 month post surgery. In the lap TME group, urinary dysfunction gradually improved over a 6-month period, which is consistent with previously reported open surgery TME studies. In other words, both lap and open TME required 6 months for ISP scores to decrease. However, interestingly, patients who underwent robotic TME showed significantly earlier recovery at a period of less than 3 months. They also analyzed the urinary flow where the most objective urinary function results were obtained. The robotic TME showed no decrease in mean voiding volume. The robotic TME urinary data analysis revealed superior outcomes compared to laparoscopic TME data, not only in ISP score but also in urinary flow. With respect to erectile function, the robotic TME group showed earlier recovery as compared to the laparoscopic TME group, 6 months versus 12 months. They stated that, during pelvic dissection, avulsion or direct injury of the nerve plexus can easily happen, which is tied to post-operative sexual and urinary dysfunction. Enhanced 3D HD magnified views, along with 7 degrees of instrument freedom, were found to be of high value during delicate dissection. In their conclusions, the authors stated, and I quote: "We conclude that the use of da Vinci's surgical robotic TME system allowed for an earlier recovery in voiding and sexual function because it enabled meticulous dissection and maintenance of adequate countertraction strength as a result of enhanced dexterity." As stated earlier, our GYN franchise remains robust. While most of our previous growth has been U.S.-centric, we are beginning to experience dVH expansion in non-U.S. markets. As was the case in the United States, complex dVH from malignant conditions appears to be the catalyst. In this month's edition of Obstetrics & Gynecology, a group made up of both surgeons and epidemiologists from Jewish General Hospital and McGill University in Montréal, published their 2-year findings on both patient outcomes and economics associated with their robotic GYN cancer program. A total of 303 endometrial cancer patients were involved in this study. Following the initial -- the initiation of their robotics program, 143 consecutive dVH patients were compared to 160 consecutive patients who underwent surgery prior to the robotic program commencement. These 160 patients made up the historical cohort. Within the historical cohort, the rate of minimally invasive surgery performed with traditional laparoscopy was 17%. During the following 2 post-da Vinci years, the MIS rate had grown to 98%. Patient characteristics were comparable in both eras, except for an even higher body mass index in the robotics era. Robotic patients had longer operating times but fewer adverse events, 13% compared to 42%; lower estimated median blood loss, lower by approximately 70%; and shorter median hospital stay, 2.2 days compared with 5.5 days. The overall hospital cost for the robotic group was significantly lower as compared with the historical group, CAD $7,644 compared with CAD $10,368. The gains with robotic surgery are even more pronounced in a multivariable analysis where they considered both the full cohorts and matched sub-cohorts. The reduction in grade 2 or higher complications resulting in far less hospitalization drove significant dVH-related hospital savings. However, the key factor in evaluating any cancer treatment is oncologic outcome. At present, the 2-year post-dVH follow-up indicates a lower recurrence rate as compared with the historical cohort. Improving procedure efficacy while reducing hospital costs is a powerful combination and one that aligns us closely to the needs of our patients, providers and payers. This concludes my remarks, and I'll now turn the time over to Calvin.