Joe E. Kiani
Analyst · Piper Jaffray
Thank you, Mark. Clearly, 2011 was a year of contrasts for Masimo. There were numerous high points including the successful completion of 2 major new whole system installations at Kaiser Permanente and Banner Health, along with the acquisition of many other new hospital customers, which helped us deliver 50% growth in both our global installed base and core SET business. For the second year in a row, we shipped approximately 150,000 drivers, up from previous annual ranges of 100,000 to 120,000 drivers, indicating the strength we saw in 2010 was not due to catch-up purchases from 2009, but to fundamental and continuing shifts in the number of customers that are migrating to Masimo SET and Masimo rainbow SET technology. We extended our royalty agreement with Covidien until at least March of 2014, which avoided -- potentially costly IP litigation. We've launched multiple new products to further strengthen the body of clinical evidence validating our technology's benefit and signed a record number of new rainbow OEM agreements including one with Philips, the world's largest patient monitoring company. Also as promised, we were able to continue our growth, while dramatically cutting the overall rate of operating expense growth to less than 7% adjusted for one-time spending in 2010. In addition in 2011, the U.S. Department of Health and Human Services recommended critical and congenital heart defect screening using motion-tolerant and low perfusion pulse oximetry, which we invented, and nationwide newborn screening standards that we expect to drive a lot of benefits from. We expect our technology to play an ever important role in saving newborn lives as these screening protocols are put in place. At the same time, 2011 brought some setbacks, including declines in U.S. hospital admission rates, a significant unanticipated decrease in sales to one of our long-time OEM partners, a lengthy delay in FDA clearance of Pronto-7, the absence of the repeat rainbow order from the U.S. Military and a delay of our rainbow-centric Radical-7 bedside device, which created inventory charges. All of this led to the worst product revenue growth rate we have ever had, at just 14%. Although 2011 was a tough year that we're glad to put behind us, we know that we've laid important groundwork over the past 12 months that gives us confidence about a brighter 2012 and beyond. While we have put many initiatives in place to achieve top line and bottom line growth in the high teens or better, we have to remain conservative with our financial outlook until we have proven to ourselves and to you that we can grow at those levels. So for now, assuming no further hospital census declines, we are forecasting product revenue growth of approximately 12%, including 32% rainbow growth and earnings growth of approximately 14%. We expect to achieve this performance, if not more, by remaining true to our vision for Masimo, which is to build a strong proprietary recurring revenue franchise with breakthrough products that solve unsolvable clinical problems and advance the standard of care. Among the reasons for our optimism in 2012 are: the continuing global growth potential for our core Signal Extraction Technology business; two, the momentum building across the OEM community behind our rainbow platform; three, the novel and bold sales and marketing programs like BTR-CR that we are rolling out to accelerate rainbow growth; four, the competitive strength of our current product lineup and new products we have on deck for debut in 2012; and finally, the ability for our global Masimo team to execute our strategy. I'll review each of these in a bit more detail starting with growing our core SET business. This begins with continuing to increase the volume of sensor sales by expanding our relationships with existing hospital customers while attracting new ones. Our progress is evident in the recent expansion of our installed base. We have shipped more than 300,000 new drivers in the last 2 years and believe we can ship another 150,000 this year, taking our existing installed base well above the $1 million -- excuse me, the 1 million unit driver mark by the end of 2012. Our confidence is based in part on the recent performance of our acute care sales team, which set a new company record for the total dollar volume of contract bookings and the second highest new hospital contract booking quarter in the history of Masimo in the fourth quarter of 2011. These contracts set the stage for new driver installations throughout 2012 and ultimately, new sensor sales and improved patient care. We're also focused on maximizing our opportunity in the international markets, where our revenues rose 20% in 2011 with the direct portion of our international business up 31%. Moreover, the mix of our international direct revenues continues to skew more heavily to consumable sales due in large part to the strength in our international contract bookings, which were up on a dollar basis by more than 50% in 2011 versus 2010 at a record for Masimo. It's important to note the number that I mentioned earlier about the contract bookings were in the U.S. only, which set not only a record for the company, but also as far as new contracts, the second highest quarter ever for the company. This is not only a foreteller of future o U.S. revenue recurring, but also shows how our prior investments to expand our international presence has established the foundation for continued growth and profitability. Of course, higher sensor volumes enhance our ability to improve manufacturing efficiency. During 2011, we said that we'd be making investments in 2011 and into 2012, an initiative to lower future product and manufacturing costs. We are moving closer to implementation of some of these supply chain initiatives, which will include automation, vertical integration, vendor localization and inventory management realignment initiatives. As Mark indicated earlier, we expect to begin to see some of the early benefits of these initiatives in our product gross margins in the second half of the year. Remember that the majority of our SET revenues are generated through long-term contracts that fix sensor price and volumes -- or minimum volumes for an average of 5 years, which minimizes price volatility and gives us the opportunity to reduce our costs over the contract term. While prices have moved down from 2008 levels, the ASPs on our single-use SpO2 sensors have held relatively steady over the last 2 years. We maintained a disciplined approach to pricing, which is grounded in the added value we offer hospital customers, including the Masimo SET gold standard pulse oximetry, an efficient and effective general ward monitoring solution and an upgradable rainbow platform that provides access to a host of breakthrough proprietary technology and measurements. Our SET technology has been proven to reduce excessive sensor usage, invasive procedures, ICU days, rapid response team activation and outpatient therapy. And our rainbow technology has been proven to reduce blood-transfusion-related costs and most importantly, together, rainbow SET saves lives and eyesight. I'll turn now to rainbow, where our confidence for 2012 is rooted in activities underway on multiple fronts to increase utilization and grow revenue. Critical to achieving broad adoption of rainbow is ensuring its availability across the range of multi-parameter OEM devices. Remember that roughly 80% of Masimo drivers shipped into the market get there through the OEM channel. We began 2012 with over 40 OEM rainbow agreements in place, more than double the number one year ago and, dramatically above our original target of 30. Most importantly, the list includes Philips, which has nearly 50% market share of the worldwide patient monitoring market. About half of these OEM partners have already released rainbow-capable products or made public announcements about their rainbow integration. Among those already selling rainbow-enabled devices are Physio-Control, Welch Allyn, Zoll and Drager. In addition to Philips, companies with announced rainbow-integration programs underway include Atom Medical and CareFusion, to name just a few. We are now turning our attention to supporting our existing rainbow OEMs, doing all we can to ensure the successful and on-time delivery on the rainbow-enabled product roadmaps. We're also implementing new sales and marketing programs, including a 2012 sales compensation plan that pays sales reps heavily on achievement of rainbow goals. Last month, we brought our global sales organization together for 3 days of training. We rolled out this 2012 plan, as well as some new SpHb initiatives, including revised and expanded financial modeling tools to help hospitals conduct individualized return on investment and operational budget analysis associated with adoption of SpHb. A new pricing strategy that we just announced today, which reduces the per patient cost of ReSposable SpHb sensor to $30, representing a roughly 50% discount for hospital customers, who make certain volume commitments. We also announced today an SpHb risk sharing program for hospital customers called BTR-CR. The program will guarantee that Blood Transfusion Related Costs Reduction, called BTR-CR, will exceed the incremental price of SpHb sensors. We plan to identify a select number of accounts who are interested in working with us to validate what many of our customers and independent researchers have found, namely that the deployment of SpHb will not only reduce mortality and morbidity, but will dramatically reduce blood usage costs. Recall that the recent MGH study to evaluate the impact of SpHb monitoring showed a 90% reduction in blood units transfused. When you consider that the typical hospital blood transfusion-related costs are roughly 10x their annual SpO2 sensor costs, we feel confident that this risk sharing program will make it abundantly clear that the higher sensor costs can be more than offset with even a modest improvement in blood management costs and shift the entire discussions about even pulse oximetry to a new level. We also know that SpHb has the potential to dramatically improve patient care and save lives. Clinicians who use it tell us it helps them identify undetected bleeding earlier in surgical, intensive care, trauma and obstetric patients; and that it helps them identify anemia more rapidly and efficiently. Our objective with these new programs is to motivate more clinicians and more hospitals to use SpHb because we are confident that once they do, they'll become ongoing customers who are convinced of its value and benefit. As an example, we recently learned of a case in Dallas, where an 8-year-old girl was undergoing a unique and complex craniofacial surgery. The patient was monitored with Radical-7 with SpHb during her surgery. After surgery, as the patient was being prepared for transfer to the recovery room, clinicians noted that her SpHb level had dropped significantly from 9.2 grams per deciliter to 6.5 grams per deciliter in just 5 minutes. When lab results came back at the critically low level of 5 grams per deciliter, confirmation was received for what Masimo SpHb had already helped clinicians conclude, that the patient was suffering from occult internal hemorrhage. Without this early warning, the child would likely have been transported out of surgery in a hypovolemic and critically anemic state. A delayed response may have resulted in tissue hypoxia, acidosis or even cardiac arrest. Afterwards, the pediatric plastic surgeon in this case told us that SpHb helped prevent a potentially life-threatening event, and that he is now using SpHb for all of his major craniofacial procedures. We expect the new SpHb initiatives, particularly the BTR-CR Program, to allow more hospitals and doctors like this one to experience the technology's benefits firsthand and incorporate it into their routine practices. We're also very excited to be in full commercial release of Pronto-7, which was cleared by the FDA last month and represents another medical -- excuse me, another Masimo medical first. Pronto-7 provides completely noninvasive and fast spot-check measurement of hemoglobin, SpO2, pulse rate and perfusion index, all from the palm of your hand. All Masimo direct sales reps are now selling the device with our 20-person physician practice sales team targeting doctors' offices in the U.S., concurrent with our recent FDA clearance for the Pronto-7. And we have implemented a guarantee program for our Pronto-7 device with a minimum sensor purchase commitment. This program will allow physician offices to work with the device for 30 days and if they are not completely satisfied, they will receive a refund for the unused portion of the SpHb sensors they purchased during that period. In addition, we are in the process of finalizing our physician practice distributor agreements and currently anticipate that we will have one or more U.S. distributors engaged in shipping Pronto-7 products by mid-year. Pronto-7 is an excellent example of the compelling cutting-edge innovation that defines and differentiates Masimo. Innovation is the foundation of our company and future success, which is why our R&D investment is typically towards the high end of industry averages. While our current product offering is robust, we plan to be introducing some exciting new products that we expect to be important contributors in 2012 and beyond. They include a rainbow-centric Radical-7 called Radical-7 2012. Our RAM revenue grew significantly in 2011, which was its first full year on the market, and we expect RAM's availability on our flagship Radical-7 launch in 2011 bedside device to fuel increased utilization in 2012. As an aside, although one of our competitors recently revealed what they considered a new technological deployment of respiratory rates from the plethysmographic waveform, Masimo has had CE mark approval for the same measurement of respiration rates via changes in the plethysmographic waveform from the pulse ox signal since Q1 2011. And in fact, we've even sold some. We've just decided not to make this a major marketing focus due to the superiority of RAM. Besides RAM and SpHb, we're also excited about the potential of the Halo Index, our dynamic wellness indicator that produces a specific numeric value designed to help clinicians better assess the patient's overall condition and predict deterioration. While we await FDA clearance, we are introducing the Halo Index to customers outside the U.S. For example, a major hospital in Singapore began using Halo Index a few months ago as part of their Patient SafetyNet deployment in the post-surgery ward. Clinicians there tell us they can already appreciate its sensitivity and usefulness in providing the combination of physiological measurements in a single number and for its ability to help recognize possible underlying problems for patients. This institution continues to work with us to collect clinical feedback. As I said before, a more clinical -- as more clinical evidence is collected on Halo Index, we expect its clinical utility in a variety of carriers and patient types to become more specific. Other new technologies helping to drive growth include the Masimo E1 trauma sensor, the industry's first single-patient use ear sensor, which enables faster detection of oxygen saturation changes during low perfusion, while avoiding the challenges and complexities of reusable ear sensors. And our new MS-2040, a Masimo circuit board that uses about a 1/3 of the power, less than 45 milliwatts, and is about half the size of our standard SET boards. This compact board is already enabling OEMs to develop a broad range of small, lightweight, handheld and wearable portable medical devices and will, we believe, lead to an expansion of the number of OEM board shipments over the coming years. Finally, we're also on track to introduce a new rainbow measurement in 2012 that we believe will mark another Masimo industry first. To summarize, Masimo has entered 2012 in an excellent position. We have superior technology and efficient global infrastructure to continue to achieve profitable growth in our core SET business. And we're building momentum behind our breakthrough rainbow platform, while developing new technologies that extend our innovation leadership. Importantly, we also have a dedicated and talented global team with the experience, industry knowledge and drive to execute our strategy. We all continue to be -- to focus our energies and resources on helping hospitals and clinicians improve the quality and cost of patient care, believing that this is the surest way to achieve much faster growth and enhance Masimo's value over the long term. With that, we'll be happy to take your questions. Operator, would you please tell us who the first questioner is.