Joe E. Kiani
Analyst · Piper Jaffray
Thank you, Mark. Before I begin, let me say what a pleasure it was to see many of you at our inaugural Investor Day in New York in 20th of September. We enjoyed the opportunity to give you an in-depth overview of our key growth strategies and technologies, and explain why we have a strong belief in Masimo's future. If you were unable to join us for the event, we hope you'll take the time to visit our website and listen to the archived webcast, particularly the clinical panel discussion, which offered enlightening perspectives on how doctors and respiratory therapists use our technologies every day to enhance the care they provide patients. For us, it was a proud reminder of the importance of our mission and guiding principles, especially our drive to always do what is best for patient care. To that end, we made good progress in the third quarter on a number of financial and operational fronts. As a result, year-over-year growth in our product revenue and installed base continue to be significantly above industry growth rates. We view this as proof that we are cementing our market position as the clear technological leader known for providing products that help clinicians solve critically challenging problems, while also helping to usher in practices and standards that improve patient care, save lives and reduce costs. Our focus on proven superior performance and innovation was on full display earlier this month at the American Society of Anesthesiologists Annual Meeting in Washington D.C. Masimo technologies were the subject of 18 clinical studies, many of them highlighting the positive clinical outcomes and patient safety impact of total hemoglobin, PBI, acoustic respiration rate and SEDLine brain function monitoring. In addition, more than 200 clinicians attended a symposium to hear leading anesthesiologists discuss their experience with SpHb PVI RAM and Patient SafetyNet, and thousands of ASA attendees jammed the Masimo exhibit to see a host of new breakthrough products. For example, we announced during ASA that our rainbow platform is expanding once again with the addition of fractional arterial oxygen saturation measurement, which will be delivered through the new rainbow super sensor. Previously, Pulse Oximeters could only measure and display functional oxygen saturation or SpO2. So when patients had elevated carboxyhemoglobin and/or elevated methemoglobin, the displayed functional oxygen saturation overestimated the actual oxygen saturation value. Masimo's new fractional arterial oxygen saturation measurement or SpfO2 will be, for the first time, non-invasively measure oxygenation in the presence of dyshemoglobin. To illustrate the importance of this, consider this example. In a patient who has an SpO2 of 98%, carboxyhemoglobin level of 12% and methemoglobin level of 1%, SpfO2 would be displaying at 85%. It is highly likely that clinicians treating this patient would frequently make different diagnostic and therapeutic decisions at an oxygenation of 85% versus 98%, which is what SpO2 would display. Both SpfO2 and the rainbow Universal ReSposable SuperSensor are pending FDA clearance, but are available in CE4 countries. At ASA, we also demonstrated the new SET Pulse Oximeter Universal ReSposable Sensor. As we have done every year since our first ASA, we also showed how our Pulse Oximeters and Pulse CO-Oximeters can measure through motion and low perfusion, while our main competitor's products can't. That difference is what has brought us here and what has helped transform patient care with reliable accurate monitoring when patients need it most, whether it's neonatal patients in the neonatal intensive care unit or any patient on the general floor. The pace and substance of our new product releases telegraph to the market our continued commitment to investing in important advances that benefit hospitals and patients, both in terms of leading-edge parameters and platforms, and in finding ways to improve existing modalities. Our Universal ReSposable pulse oximetry sensor, a progressive sensor configuration that combines the performance, accuracy and comfort of a single-patient use Masimo SET sensor with the cost-effectiveness and environmental advantages of a reusable sensor, is a good example. More than ever, hospitals are under pressure to reduce costs and implement green initiatives. With Masimo Universal ReSposable sensors, hospital material management departments can meet cost reduction edicts, while helping their hospital advance environmental and safety goals and most importantly, ensure that their patients are provided with accurate monitoring when they need it most. We also demonstrated the recently FDA-cleared uSpO2, Universal Pulse Oximetry Cable, with GE Healthcare's ApexPro Telemetry System. This unique technology is a board and cable Pulse Oximetry solution that embeds a Masimo SET circuit board within a completely self-contained cable providing a simple way for hospitals to add Masimo SET Pulse Oximetry to devices that weren't designed with SpO2 integrated inside the device. GE Healthcare is the first to integrate this low power Masimo SET platform into patient-worn monitors designed for use in ambulatory patient care settings. Clinicians are very excited to have this capability, which will help them to enhance workflow due to improved monitoring and reduction of false alarms on these more active patients. Late in the third quarter, we received FDA clearance for Masimo SET Pulse Oximeters, rainbow SET Pulse Co-Oximeters and neonatal sensors with labeling for screening newborns for critical congenital heart disease. This marks the first time the FDA has cleared specific labeling indicating the use of Pulse Oximeters in conjunction with a physical exam to screen newborns for CCHD. CCHD affects 5 to 10 of every 1,000 newborns resulting in 3% of all infant mortality. Improving early detection and treatment is critical because up to 30% of all CCHD-related deaths in the first year of life are due to failure to detect the condition. Following the action last year by the U.S. Department of Health and Human Services to add measure through motion and low perfusion Pulse Oximetry CCHD screening for newborns as part of their recommended uniform screening panel, California recently became the latest state to mandate such screening. We are proud of the role our technology has played in helping clinicians save babies' lives and are actively engaged in efforts to educate current and prospective hospital customers treating patients in labor and delivery, well-baby nurseries and neonatal intensive care units about the importance and proper methods for conducting CCHD screening with motion and low profusion tolerant Pulse Oximetry. A fundamental component of our growth strategy is continuous monitoring on the general ward with our Patient SafetyNet remote monitoring system. Masimo Patient SafetyNet tracks the underlying physiological conditions of patients and detects changes and abnormalities that signal declining health status in real time. When a patient's condition deteriorates, the system automatically sends wireless alerts directly to clinicians, prompting a potentially life-saving response to the bedside of the patient. In the third quarter, the Joint Commission issued a Sentinel Event Alert on safe use of opioids in hospitals and recommended better opioid dosing along with oxygenation and ventilation monitoring in postsurgical patients. Opioid analgesics rank among the drugs most frequently associated with adverse drug effects. In fact, of opioid-related adverse drug events, including death, that occurred in the hospitals and reported to the Joint Commission Sentinel Event Alert database between 2004 and 2011, 29% were related to improper monitoring of the patients, second only to dosing medication errors. To help hospitals comply with the Joint Commission edict and similar recommendations from the Anesthesia Patients Safety Foundation, Masimo has a 1 and above [ph], if not the most comprehensive continuous monitoring offering including Measure-Through Motion and low profusion pulse oximetry, acoustic respiration rate monitoring and a full suite of sidestream and mainstream capnography options, which we added in July with our acquisition of PHASEIN. Roughly 3 months following the acquisition, we couldn't be more satisfied with the strength of the technology and the team. Integration is progressing on schedule and includes a reassessment of manufacturing activities and identification of areas where we will expand PHASEIN's R&D efforts through 2013 to address additional market opportunities. The addition of capnography to our product offering ensures that we can provide customers a full range of respiration- and ventilation-monitoring choices. However, it is our belief that rainbow acoustic respiration rate monitoring, RAM, will ultimately surpass other forms of ventilation monitoring because it is entirely noninvasive, easy to administer, well tolerated by patients and as accurate as respiration rates from capnography. Evidence of this continues to build with new clinical studies that confirm RAM's performance. At the recent ASA, 3 separate studies showed that respiration rate measured with RAM displayed similar accuracy and precision to capnography. One of these was a study conducted in anesthetized patients under sedation at Stanford University School of Medicine, where researchers concluded that the use of RRa or RAM could be a good alternative for the perioperative period as most patients will have received sedation during surgery and need to be monitored in the post-anesthesia care unit and later on the patient wards. RAM's, of course, a primary growth engine within our Masimo rainbow SET platform, which delivered solid 41% year-over-year growth in the third quarter. Importantly, consumables represented roughly 45% of total rainbow revenue in the third quarter, which is similar to the second quarter of 2012 level and an encouraging indication that adoption is on the rise. Leading rainbow's growth in the third quarter was SpHb, which grew 92%, due primarily to higher consumable sales, indicating that SpHb continues to gain traction among our customers. As you know, in 2012, we increased our commitment to educate clinicians and hospital administrators regarding the problems associated with unnecessary blood transfusions and the ability of SpHb to help reduce unnecessary blood transfusions by providing continuous real-time hemoglobin trending. As part of this, we rolled out the Better Care guarantee, which is designed to stimulate customer adoption by reducing the risk and upfront cost. Under the program, a customer replaces their Pulse Oximetry adhesive sensors with rainbow Pulse CO-Oximetry sensors, and Masimo guarantees that the reduction in blood transfusion-related costs will exceed the incremental price paid for rainbow sensors or Masimo will refund the difference. Our first Better Care guarantee program is now underway at a prestigious academic medical center in the U.S. Interestingly, some customers after considering SpHb in the Better Care program decided in the third quarter to bypass the Better Care guarantee altogether and move directly to full adoption of SpHb. These include prestigious hospitals in Japan and Europe. As we noted last quarter, we continue to see increasing levels of interest in our Better Care program and now have more than 50 hospitals throughout the world who are actively engaged in discussions with us regarding the program. We expect to see more customers take advantage of this program in Q4 with even stronger adoption as we move into 2013. The volume SpHb clinical evidence also continues to expand. At ASA, researchers from Fujisawa Municipal Hospital in Japan represented a study indicating that SpHb monitoring contributes to effective ultrafiltration and stable blood purification. And researchers from Seoul National University Hospital in Korea presented a study concluding that SpHb monitoring with the Radical-7 can be useful as a trend monitor in children during operation, even immediately after volume expanders are administered. Late in the third quarter, our new distribution partners, Henry Schein and PSS World Medical, commenced sales of Pronto and Pronto-7 devices and sensors in the physician practice market. We're excited about this opportunity because total hemoglobin is one of the most frequently ordered laboratory tests in hospitals, urgent care centers, physicians' offices and public health clinics. Existing point of care testing method are time-consuming for the clinician and expose the patient, clinician and health-care facility to potential contamination and blood-borne pathogens. Conversely, Pronto and Pronto-7 offer noninvasive and quick total hemoglobin testing along with SpO2, pulse rate and profusion index with no needle sticks, contamination risks, lab consumables or waste disposal. A study published recently in Postgraduate Medicine confirmed that -- these benefits. Not only did the study show Pronto SpHb measurement to be equivalent to the bias and limits of agreement of the HemoCue 201 Plus, the most commonly used invasive point-of-care total hemoglobin analyzer, in outpatient setting, but these researchers also said that because SpHb measurement is noninvasive, it has the potential to confer the additional benefits of patient comfort, decreased complexity and increased safety for health-care professionals. SpHb is the cornerstone of our rainbow platform for its long-term potential to improve the practice of medicine, reduce costs and ultimately become a standard of care. Recent favorable trends in total revenue, new customers, consumable sales, adoption by our OEM partners and clinical evidence are giving us confidence that our years of work to build the rainbow market are starting to translate into sustained growth. In closing, our third quarter financial results demonstrate our ability to take full advantage of our recurring revenue business model and innovation leadership to seize multiple growth opportunities across a variety of patient care settings. Our core SET business grew 10% and our global installed base grew 11%, continuing to outpace market growth. Our rainbow product sales were among the most robust yet, at 41% growth, fueled by a strong 92% hemoglobin SpHb growth. We enhanced our competitive position with a strategic acquisition that added capnography and anesthetic agent monitoring to our product lineup. We introduced a series of important new innovations, sensors, parameters and platforms, all designed to address clinically relevant problems while lowering health-care costs. And strong cash flows helped us maintain a healthy balance sheet, providing flexibility to do what is in the best interest of stockholders, including returning cash to stockholders with the special dividend announced today. With that, we'll be happy to take your questions. Thank you. Operator?