Joe Kiani
Analyst · Piper Jaffray
Thank you, Mark. I'll frame my strategic update with the key objectives that provided investors at the start of 2011, beginning with leveraging our global sales force. We've held the size of our sales organization relatively steady over the past few quarters while still delivering 24% growth in direct SET and Rainbow SET sales. And as evidenced by our expanding installed base, we continue the pace of new business wins and renewals. Among the recent additions are Mount Sinai Medical Center in New York, which includes Mount Sinai hospital, one of the nation's largest and most respected hospitals; and South Broward Hospital District, known as Memorial Healthcare. This system includes 6 acute care hospitals serving South Florida. As a strong outside the U.S. revenue performance indicates, we're also experiencing a rise in new international customers, more outside the U.S. healthcare systems are recognizing the benefits of hospital-wide conversion to Masimo. The pace of new multiyear contracts was particularly strong for us in Germany in the second quarter, with recent new Masimo hospital customers in Europe, including DRK Kliniken Berlin, which is a 5-hospital system; and Erasmus Medical Center, a 1,320-bed acute care hospital in Rotterdam, Poland. The key to our progress is our ability to complement our gold standard Signal Extraction Technology pulse oximetry with breakthrough technology such as noninvasive hemoglobin, carbon monoxide and Rainbow acoustic respiration rate monitoring, as well as our Patient SafetyNet system for monitoring patients on the general ward. Another 2011 objective is to increase Rainbow awareness and adoption. In June, despite our ongoing intellectual property litigation, we entered into a long-term Rainbow agreement with Philips. We are now engaged in diligent co-development with Philips, which should allow Rainbow SET platform to be available in Philips products worldwide. Given Philips' significant market share, we believe the agreement will broaden the availability and adoption of Rainbow measurements, helping to expand Rainbow use by more clinicians in more care areas of more hospitals for the benefit of patient care. We've received enthusiastic feedback from customers who use Philips' multiparameter monitor devices and are eager to gain access to our full suite of Rainbow SET technology through Philips' patient monitors. Increasing the number of OEMs who offer Rainbow SET is an important component of our long-term Rainbow growth strategy. The Philips agreement represents a big step forward. At the end of the second quarter, we had more than 25 OEM Rainbow agreements in place, including development agreements. And we still expect the count to exceed 30 by year end. The body of clinical research on noninvasive hemoglobin or SpHb continues to expand. Today, more than 50 clinical studies have been completed, showing SpHb's ability to help clinicians assess hemoglobin status and determine treatment and additional test options in surgery, critical care, outpatient care areas and emergency department. For example, in the second quarter, multiple clinical research studies were presented at the European Society of Anaesthesiology Annual Congress in Amsterdam, showing clinically-acceptable correlation between SpHb and invasive lab values in surgical and emergency department patients. Good correlation was also shown in a study conducted at Madigan Army Medical Center in Tacoma, Washington and published recently in the American Journal of Surgery. These studies, after the recent clinical trials that showed SpHb, helped reduce blood transfusion by nearly 90% in orthopedic patients at Mass General Hospital. Just yesterday, we reinitiated the limited market release of the Pronto-7 in Europe, Middle East, Africa, South America and Asia, except for countries requiring clearance, such as Japan. This spot check device, which is pending FDA clearance, is now available with a family of sensors to accommodate a broader range of figure sizes and optimize its operation. Because these new sensor sites are designed to more snugly fit the patient's finger, we believe that the measurement performance will improve. In addition, we have altered the design of these sensors to position the thermistor above the bottom padding to quickly and accurately measure finger temperature, which was the primary issue that led us to implement a voluntary recall of the Pronto-7 sensor late last year. As for the Masimo's verification process, well over 10,000 Pronto-7 measurements were performed on more than 1,400 subjects at 14 sites and compared to hemoglobin measurements from a venous blood sample analyzed on a hematology analyzer known as the Coulter Counter. This testing resulted in an accuracy specification of 1 gram per deciliter for normal sensitivity mode and 1.1 gram per deciliter for max sensitivity mode. While not a regulatory requirement prior to lifting the voluntary recall, we elected to perform additional testing on Pronto-7 devices and the new Rainbow 4D sensors. This additional testing included 474 subjects in 3 outpatient clinical-type environment. The hemoglobin measurements from the Pronto-7 and point-of-care device using capillary blood with a Hemocue machine were compared to hemoglobin measurements from a venous blood sample analyzed on a Coulter Counter. The Pronto-7 showed an accuracy of 1.1 gram per deciliter, while the invasive Hemocue point-of-care device showed an accuracy of 1.6 gram per deciliter. Unfortunately, the regulatory road in the U.S. has been exceptionally windy recently. We still don't have FDA clearance for Pronto-7 and don't know when we will. As you know, we said earlier this year that we expect the total 2011 Rainbow revenue to range from $40 million to $50 million. The upper end of this range was premised on reinitiating our limited market release of Pronto-7 by mid-2011 worldwide, including the U.S. Given that we have not received FDA clearance yet for the U.S., we now believe that our total Rainbow revenue will be at the lower end of our previous guidance range. However, we are not revising our original February 2011 product revenue guidance of $415 million to $430 million, albeit we probably will be at the lower end of this range. Now I would like to share some exciting news regarding our planned Q3 2011 rollout of a new technology that will be integrated into all of our sensors. This will go a long way towards protecting the intellectual property in our SET technology as it already exists fully with our Rainbow Sensors. It also will ensure the integrity of the Masimo technology and brand name while enabling a very accurate single-patient-use ear sensor called the E1 that we recently announced. Importantly, these technological changes will end the illegal knockoff manufacturing of our sensors, which we believe is occurring primarily in Asia and to a lesser extent in Europe. While this new technology will add, in short run, some additional costs to our sensors, it represents an important and necessary investment and protection of our intellectual property, as well as providing our customers with the knowledge that they are benefiting from and receiving the gold standard Masimo technology. As many of you are aware, we often discover cases when our customer calls to report that our products don't work. When we look into these situations, most if not all of the time, it is because our customers are not using genuine Masimo sensors. We believe this new technology we are adding to all of our sensors will ensure that our customers are receiving the performance they expect from their Masimo technology for the sake of the patients. Because of the reduction in our Rainbow revenue expectations and the short-term impact of this new sensor technological change, we now expect full-year 2011 gross profit margins to be at the low end of our previous 65.5% to 67.5% annual guidance. Touching briefly on another key objective, our research and development teams continue to pursue solutions to clinically-relevant problems, and we remain committed to introducing breakthrough products. Through their efforts, as I mentioned earlier, we recently introduced the industry's first single-patient-use ear sensor. Compared to digit sensor, it enables faster detection of oxygen saturation changes during low perfusion due to a variety of clinical factors, yet doesn't suffer from errors due to venous pulsation that forehead sensors typically have. And unlike reusable ear sensors, it stays on better, avoids cross-contamination risks and reduces sensor management complexity. We also recently launched the MS-2040, the first Masimo SET board that uses approximately 40 milliwatts and measures about half the size of a standard Masimo SET print circuit boards. This new board will enable a broad range of small, lightweight handheld and wearable portable medical device possibilities. To complement our internal research and development efforts, we continue to explore strategic acquisitions and agreements that provide access to complementary technologies that we can incorporate into our existing and future platforms. I'll close with a few comments about our markets, which remain tumultuous, within the healthcare sector, legislative and regulatory reforms, concerns over changes in reimbursement rates and the need to reduce healthcare costs overall are weighing on the industry. These are, of course, coupled with a host of macroeconomic concerns from European financial woes and the U.S. debt political situation to continue with high unemployment and the like. While we believe Masimo is capable of top line growth of at least 20%, we are happy that in the midst of these uncertain times, we continue to achieve solid double digit revenue growth. We do this by continuing to attract new customers and renew our existing relationships with our breakthrough technology that address important clinical problems. This is apparent in our strong driver shipments, which lay the groundwork for continued market share gains in the future. In fact, if we keep shipping drivers at the current rate, we expect our sensor business to eventually catch up with our driver market share. This is significant when you consider that iData, a third-party research firm, estimates our share of the U.S. sensor market at 32% and our share of new placements of stand-alone pulse oximetry monitoring equipment market at 50%. Moreover, we're delivering this performance while controlling our rate of operating expense growth and remaining focused on developing new innovations that improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. These new innovations are just beginning to form the bottoms of the technology adoption S curve, and we remain confident that Masimo is still in the early stages of a long-term growth story. We are enthusiastic about our new stock repurchase program, which emphasizes this conviction in our growth prospects: business model and cash flow generation capability. With that, we'll be happy to take your questions. Operator?