Joe E. Kiani
Analyst · Piper Jaffray
Thanks, Mark. Our performance in the quarter showed the positive momentum that continues to form behind the Masimo growth strategy, which is to build a strong, proprietary, recurring revenue franchise with breakthrough products that solve unsolvable clinical problems, advance the standard of care and lower health care costs. The foundation of this strategy is our core Signal Extraction Technology Pulse Oximetry business, which again, this quarter, posted revenue and installed base growth rate significantly above competitor and market levels, giving us confidence that our global market presence is hitting new highs. The accuracy, reliability and cost-effectiveness of our Masimo SET pulse oximetry technology, along with our efficient and intuitive Patient SafetyNet solution for the general ward, are helping us to strengthen existing hospital customer relationships and win new businesses. This was apparent in the brisk pace of long-term sensor contract bookings with new prestigious hospitals in the first quarter, which were up significantly from one year ago and followed the record-setting booking levels we delivered in the fourth quarter of 2011. The prime motivator for hospitals to choose Masimo over competing systems is to be at the standard-of-care level for pulse oximetry monitoring and the ability to access our upgradable rainbow SET platform, the first and only technology to noninvasively and continuously monitor total hemoglobin, carbon monoxide, methemoglobin, fluids responsiveness and respiration rate. Consequently, an increasing number of our customer relationships now include deployment of one or more rainbow measurements. While rainbow grew less than we had expected, the slower growth was not due to SpHb, which grew 70%, or to RAM, which more than doubled compared to Q1 2011. Rather, it was due to softer sales of SpCO and SpMet, which is predominantly purchased by EMS customers. Unfortunately, ever since the 2008 great recession, municipalities have not had the tax revenues that fueled EMS product sales. We expect, as the recession ends, that business will begin to grow faster in the EMS environment. We continue to focus on products and programs that enhance rainbow's accessibility and ease of use for clinicians and hospitals. For example, during the first quarter, we debuted the 2012 Radical-7 bedside monitor, which is clinician and rainbow-centric and provides a variety of features designed to simplify the clinician's life. This new monitor, now in premarket release, offers exceptionally easy operation, a view of all rainbow parameters and instant adaptability to change displays and settings on-the-fly. With a quick touch drag and drop, clinicians can move any parameter to and from the center and bottom of the display, never losing track of any vital signs and yet seeing boldly what they want to see. The instant-trend feature provides the ability to view 1 or 2 parameters at once and, with simple finger motion, clinicians can move, expand or collapse parameter trends for a real-time analysis. It is versatile in multiple care areas, with an automatic rotational screen for either horizontal or vertical display, and it can be used as a stand-alone device at bedside, as a detachable, untethered, wireless wearable device, or as multi-parameter monitoring interface with SatShare. I know Steve Jobs' biographer, Walter Isaacson noted in his book that while at Methodist University in Memphis, Tennessee, Jobs remarked that he hated the oxygen monitor they put on his finger and told his caregivers it was ugly and too complex. I can confirm that this hospital was not a Masimo customer at the time, so Jobs was obviously not referring to our Radical. I am curious what Jobs would have thought about our Radical, even the old one. But I wish he was alive, and we would have shown him the clinician and rainbow-centric Radical. I think he would have liked it. The clinicians of the World Congress of Anesthesiologists certainly did. We unveiled it there in March, and the reception was overwhelming. Clinicians from around the world were excited by its functionality and ease of use and told us they had never seen a device quite like it. The clinician-centric Radical-7 is first part in a series of system solutions that we will ultimately introduce to improve the process of care. We're also excited about customers' response to our innovative Blood Transfusion Related Costs Reduction guarantee or "Better Care" Program, a risk-sharing initiative we rolled out in Q1 that guarantees blood transfusion-related cost reductions for participating customers will be greater than the additional cost of the rainbow ReSposable sensors. Under the program, Masimo guarantees that when a hospital replaces its standard pulse oximetry adhesive sensors with ReSposable rainbow Pulse CO-Oximetry adhesive sensors and begins monitoring noninvasive hemoglobin in addition to other rainbow SET Pulse CO-Oximetry measurements, it will experience a reduction in blood transfusion costs well in excess of the incremental price paid for the rainbow Pulse CO-Oximetry sensors. The Better Care guarantee program is quickly capturing the attention of key clinicians and C-suite level hospital executives. We're actively engaged in discussion with a number of interested customers and are confident the program will help to not only validate SpHb's ability to improve patient care, but also its ability to lower costs. A new study from Johns Hopkins Hospital and published in the April issue of Anesthesiology spotlights the fact that many surgeons transfuse more blood than necessary, putting patients at risk. The 18-month study, which collected data on more than 48,000 surgical patients, reveals significant variation in the frequency of blood transfusions among the institution's surgical services and surgical procedures and among its individual anesthesiologists and surgeons. Transfusions, of course, are inherently risky and can cause a range of adverse reactions which often translate into longer hospital stays, slower recovery and higher medical bills, if not mortality and morbidity. As more and more hospitals begin to focus on improving their blood management programs, we expect SpHb, with its ability to monitor and trend hemoglobin in real time, to become an essential part of clinical decision-making on when and how much to transfuse. Paramount to achieving broader utilization of rainbow is ensuring its availability in OEM multi-parameter patient monitoring devices deployed in hospitals around the world. We are achieving this through expanded agreements with our OEM partners to incorporate Masimo rainbow SET into their patient monitors. This effort took a major step forward in the first quarter when we announced an agreement with GE Healthcare, the world's second largest patient monitoring company, to incorporate Masimo rainbow SET into many of their monitors. You will recall that Philips, the world's #1 patient monitoring company in terms of market share, signed a similar agreement with us last year. So with these 2 leaders, along with approximately 40 other agreements already secured, we now have a vast majority of the global patient monitoring providers in some stage of converting to Masimo rainbow SET technology. This isn't a transition that happens overnight. In fact we estimate that it can be 1 to 2 years between the time an agreement is signed and rainbow SET equipment from each OEM enters the market. Nevertheless, we're well on our way to making rainbow broadly accessible to hospitals, clinicians and patients everywhere. At the same time, the body of clinical research continues to expand, demonstrating rainbow's accuracy and efficacy in a range of care settings. At last count, we had over 100 studies completed on rainbow and over 100 active rainbow studies. A major study that we are anxious to see begin is being conducted by the Society for the Advancement of Blood Management with principal investigator Dr. Aryeh Shander, a world-leading authority on blood management. The study is named Nacho, especially appropriate for upcoming Cinco de Mayo celebrations but, in our case, stands for noninvasive and continuous hemoglobin monitoring -- with an O at the end, instead of an M -- for surgical blood management, is a randomized controlled trial of several hundred patients in at least 4 centers in 3 countries. U.S., Germany and Japan, and is set to start by the third quarter. Half the patients will be treated by clinicians who will use SpHb monitoring on a Radical-7 to supplement their blood transfusion decisions. And the other half will have the SpHb data collected, but it will be blinded to the treating clinicians. In contrast to the Massachusetts General Hospital randomized controlled trial that focused on surgical patients with low expected blood loss, which showed a 90% reduction on blood transfusion, the Nacho study will focus on surgical patients with high expected blood loss and is powered for a 25% reduction in blood transfusion. In patients with a higher absolute blood loss, a 25% reduction would actually result in higher savings of unnecessary blood transfusion than the 90% shown in the Mass General study. If this study meets its primary end point, the clinical community will have 2 randomized controlled trials showing SpHb monitoring technology reduces blood transfusions, a significant clinical and financial end point. Most new monitoring technologies never show any outcome differences in randomized controlled trials. While these study results could ultimately be profound, we hear today that continuous SpHb monitoring is saving lives in the intensive care unit and delivery rooms. Related to rainbow, Pleth Variability Index or PVI, a new study was recently published in the April issue of peer-review journal, Bioscience Trends, which showed that noninvasive and continuous monitoring of Masimo PVI help clinicians assess fluid responsiveness during major abdominal survey. It confirms that PVI results were similar to invasive, more expensive stroke volume variation or SVV, from a flow track catheter. Researchers concluded that monitoring fluid responsiveness using a noninvasive device may be helpful for fluid optimization in the operating room, especially in some patients who do not need invasive artery monitoring. Multiple studies have shown PVI helps clinicians assess fluid responsiveness in surgical mechanically ventilated patients, helping clinicians improve fluid management to reduce patient risk. Although fluid administration is critical to optimizing patient status and enabling end organ preservation, unnecessary fluid administration is associated with increased morbidity and mortality. Consistent with our strategy to make Masimo measurements beyond the hospital and take it to other care settings, our full commercial launch of Pronto-7 is now in full swing. Of course, we started the quarter with good news about the FDA clearance of this breakthrough handheld device, which conveniently and noninvasively measures total hemoglobin, SpO2, pulse rate and perfusion index in a minute. Today, all of our direct acute care sales reps are selling the Pronto-7, and our 20-person physician practice sales team is targeting U.S. physicians' offices. We are working to finalize Pronto-7 agreements with one or more U.S. physician practice distributors, which will dramatically expand our reach to more than 200,000 physician offices nationwide. Our goal is to be shipping via a distributor by midyear. Moreover, just a few weeks ago, we announced regulatory clearance of Pronto-7 in China and South Korea, expanding our growth opportunities in key emerging markets. The Pronto-7 and other technologies that make up the Masimo rainbow platform require anywhere from 8 to 15 specialized light emitting diodes in order to gather the optical data necessary to produce the Pulse CO-Oximetry rainbow measurements. To ensure the availability of these sophisticated optoelectronic chips, we recently acquired the assets of Spire Semiconductor, an advanced semiconductor device foundry service business. Now a wholly owned subsidiary called Masimo Semiconductor, this New Hampshire-based organization has developed groundbreaking LED and photodetection technologies with application in solar cells, photodynamic therapy, oxygen sensing and infrared imaging. We researched firstly all the manufacturers in this space and selected Spire because we were most impressed with their capability and expertise and with the way we saw their focus on breakthrough innovations complimenting Masimo's vision. With Masimo Semiconductor, we will be able to stabilize our rainbow LED supply chain for expected future demand, develop and manufacture custom components, accelerate our R&D cycles and optimize feature development costs. We expect the acquisition of the assets of Masimo Semiconductor to be mostly dilutive to 2012 earnings, which we incorporated into our revised March 12 guidance at the same time we announced the transaction. However, we expect the impact of the Masimo Semiconductor business to earnings to be neutral in 2013 and accretive thereafter. Let me close by reminding investors that since 2004, Masimo has delivered annual revenue growth in the $40 million to $60 million range, which translated into a range between 56% to 14% annual growth over the 7-year period. We have achieved this organic growth by continuing to convert hospitals to our gold standard SET technology. And while the percentage growth we expect from Masimo, which is north of 20%, will not happen without dramatic growth in rainbow, we believe our first quarter results speak to the underlying strength of our business model, the value of our technology to the practice of medicine and the fact that we continue to convert as many new hospitals to Masimo as we always have. Customer enthusiasm continues to build for our breakthrough technologies such as SpHb, RAM, Patient SafetyNet and Pronto-7. Of all these, if just one was to become standard of care, I am convinced that SpHb will become the standard of care because it is saving lives by detecting occult bleeding in places like the intensive care unit and labor and delivery, and is the first monitor since the introduction of Masimo SET Pulse Oximetry to show improvement in outcomes in a randomized controlled trial as evidenced by the Mass General study. We also continue to push the envelope with new innovations like our 2012 Radical-7 bedside device and the Halo Index, or dynamic wellness indicator, which is still pending FDA clearance. The swift completion of our 3 million share stock repurchase program underscores our confidence in our future. As I've said many times before, new Masimo breakthrough measurements like SpHb follow an S-curve-like pattern of adoption, and it is hard to predict when we will reach the steep part of that growth curve. We remain fully focused on opportunities ahead of us and believe we are in excellent position to achieve solid top and bottom line growth for years to come. With that, we'll be happy to take your questions. Operator?