Alex Gorsky
Analyst · Matthew Dodds with Citigroup
Thank you, Dominic, and good morning, everyone. I last spoke with you in detail about our medical devices and diagnostic segment a little more than a year ago when we gathered in New Brunswick for an all-day session. At that meeting, we discussed the overall MD&D market as well as our strategies to succeed in this market. Since that time, there have been some significant changes in the macroeconomic environment and therefore in the marketplace. Namely, we are seeing slower market growth, particularly in developed countries around the world, but we do remain confident in the market's long-term growth potential. I'll talk more about that in a moment. Also since last year, we've been executing well against our strategic priorities. First, we've launched a number of innovative products across a wide range of our businesses, allowing us to strengthen our largest core franchises, gain share in our high-growth businesses, and expand into some new market segments. We believe that many of these products are real game changers, and I'll highlight a few of them today. We've continued to advance our robust pipeline across our businesses. As with our recently launched products, we feel that a number of our pipeline products also have real breakthrough potential, and I'll highlight a few of them today as well. And we strengthened our global presence, especially in emerging markets like China and India, and I'll provide you with some examples of that today too. We've also made some significant decisions to shape our portfolio of businesses for growth, and I'll describe some of these decisions to you as well. So let's start by taking a look at the overall MD&D market and what we're seeing. We continue to believe this market has solid long-term growth potential due to a number of tailwinds that you see on the left-hand side of this slide. I'll highlight each briefly. First, populations in the developed world are aging rapidly. In large countries like Japan, Germany and Italy, more than 20% of the total population is already over 65 years of age. That percentage is rising rapidly in other developed nations, including the U.S., with a first of approximately 77 million baby boomers began turning 65 this year at the astonishing rate of 1 person every 8 seconds. As most of us know from personal experience, we consume more healthcare as we grow older. In fact, those over the age of 65 consume an average of 7 times more healthcare per year than those under the age of 65. A second tailwind is the growing demand for healthcare that we're seeing in emerging markets. China, for example, has lifted more than 400 million people out of poverty in the last 20 years. As standards of living rise, people increasingly expect and are able to afford better healthcare. A third tailwind is the fact that significant unmet medical needs remain in both the developed and the developing world. The diseases that our products help treat, osteoarthritis, cardiovascular disease, diabetes, presbyopia, obesity, affect hundreds of millions of people today with prevalence rates that are on the rise globally. Finally, we live in a time of tremendous scientific and technological progress. I was in Asia just a few weeks ago and had the pleasure of visiting with the number of high-tech companies outside of the healthcare industry. When you think about the advances that are being made in terms of our understanding of disease, and you couple that with some of the incredible new technologies that are being developed, it's a very exciting time to be in our space. But there are very significant headwinds facing us too, and you see them here; continued high unemployment and deficit concerns in the United States; austerity measures in Western Europe; a tougher regulatory environment worldwide; a tougher pricing and reimbursement environment worldwide. None of these will come as any surprise to you, but I think it's fair to say that these headwinds are proving to be stronger and more persistent than we would have hoped, and we are feeling their effects. I'll give you just a few examples. First, we've seen declining in-hospital surgical procedures in the U.S. for 6 straight quarters through the first quarter of this year, a good proxy for the overall strength of the MD&D market. Visits to physicians' offices in the United States, another key indicator, declined throughout 2010, and we've seen little if any recovery thus far in 2011. Some of you have written about what you're seeing recently, noting procedure volumes still appear to be soft. Looking at price, we saw a slight price decline in our markets collectively last year on a global basis, and price continues to be a challenge for us this year, particularly in certain market segments. A few years ago, price was a neutral to positive factor in our overall performance. Having said all that, we believe that J&J's market leadership positions, our depth and breadth, and our capabilities and expertise position us to move forward despite these headwinds, but they are challenging. So what does all this mean in terms of our market outlook? As we've said in the past, the global MD&D market is worth roughly $350 billion a year. From the pie chart on the left, you see the market is split about evenly between the U.S. and the rest of the world. And we estimate that the total market will grow at a 5-year compound annual growth rate of about 5%. Shifting to the pie chart on the right, J&J competes in almost 2/3 of the overall market, and we expect the segments in which we compete to grow at roughly the same rate as the total market. In 2011, we expect a slower full year market growth than we saw in 2010. We anticipate faster market growth as we move into the 2012 to 2015 timeframe as the global economy gradually improves, as more people come into the U.S. healthcare system through healthcare reform, and as demand in emerging markets continue to rise. We can see the impact of slower market growth in our second quarter results, which Louise reviewed earlier, as well as on our performance through the first 6 months of the year, which I'll discuss briefly now. MD&D's total sales for the first 6 months of the year were $13 billion, up 1.3% operationally from the prior year and 5.2% on a reported basis. Sales in the U.S. were roughly flat operationally, while sales outside the United States increased on an operational basis by 2.5%. Excluding drug-eluting stent, total MD&D sales increased about 3% operationally. Despite a challenging market environment, 6 of our 7 franchises generated positive growth, led by our diabetes care franchise, which grew at 6% operationally. Our Ethicon and Vision Care franchises each grew at 4% operationally, while our ortho clinical diagnostics Ethicon endo-surgery and DePuy franchises each grew at 2% operationally. Sales of our cardiovascular care franchise declined 12% operationally but were up 3% excluding drug-eluting stents. Spending just a moment on DePuy since it's our largest franchise, Louise mentioned some of the pressures that we've been seeing in hips and knees, with both segments of the market growing at rates well below historical levels. In the U.S., patients are reluctant to step away from their jobs at a time of persistently high unemployment, and they often can't afford the higher co-pays they're being asked to cover. Austerity measures in Europe are leading to longer queues for both hip and knee replacements. From a share perspective, we're holding our own in knees globally, but we have lost some share in hips, especially in the U.S. due to the recall of our ASR product. Moving forward, we have several new product launches planned that we believe will strengthen our competitiveness in both these businesses. In hips, for example, our new RECLAIM system approved in the U.S. earlier this year and approved just a few weeks ago in Europe, along with our new GRIPTON TF product, should strengthen our position in the fast-growing revision segment of the market. Additionally, we recently launched a comprehensive patient education campaign in the U.S. that encourages people living with chronic knee or hip pain to talk to an orthopedic surgeon about treatment options, a campaign that we hope will contribute to stronger procedure growth. Elsewhere in DePuy, we are continuing the rollout of the COUGAR LS Lateral Cage, which should strengthen our spine business in the fast-growing lateral approach segment. While our neurovascular business has been doing well, thanks in part to our new line of GALAXY coils and products added to the 2010 acquisition of Micrus Endovascular. At a time of slower market growth, we remain committed to our long-standing goal of sustaining or gaining share in the market segments where we compete. Within our 7 franchises, we track 20 major product platforms that account for about 90% of our total sales. To give you an example of what I mean, our Ethicon franchise includes 4 major platforms: sutures, biosurgicals, aesthetics and ears, nose and throat. Based on all available data, we sustained or gained share in 3 quarters of these 20 platforms through the first 3 months of the year, and we estimate this will be the case for the first 6 months of the year as well. Obviously, we'd like to go for 20 for '20, but we're pleased with our performance especially when you consider that we're already number 1 or number 2 in most of these platforms. At a time of slower market growth, we are also more focused than ever on executing against our strategic priorities. Launching innovative products, advancing a robust pipeline, broadening our geographic presence and achieving these first 3 by focusing on our talented people around the world. So let me spend a few minutes taking you now through these strategic priorities, starting with innovative products. You know when you look at our 20 platforms, there's a real mix in terms of size, maturity and growth rates. We have some very large platforms where we've been a significant player for a long time, platforms like contact lenses, sutures and SMBG. These platforms typically don't grow at double-digit rates for us, but they form a terrific and consistent core foundation upon which we can build the rest of our business. We have another set of platforms where we often do see high single-digit or double-digit growth and where there's still a lot of runway left. Electrophysiology, energy, biosurgicals and infection prevention are some of the platforms in this category, and they are the real growth engines for us today. And then we have some new platforms, businesses that we've entered fairly recently typically through an acquisition but are relatively small today, but they have the potential to be the real growth engines of tomorrow. The common denominator of success across all of these platforms is that you need to introduce a steady stream of innovative new products with great execution. In contact lenses, for example, which is our single largest platform, we continue to drive growth in daily disposables, one of the fastest growing segments of the market worldwide. In the U.S., sales of 1-day ACUVUE MOIST and 1-day ACUVUE TruEye has made us number in the daily disposables segment. TruEye is the world's first daily disposable silicone hydrogel contact lens, offering patients a level of all-day comfort that is not just superior to competing lenses but actually comparable to wearing no lenses at all, a remarkable achievement. In Asia-Pacific and Europe, we've been rolling out 1-day ACUVUE MOIST for astigmatism, powered by BLINK STABILIZED technology that positions the lens quickly and keeps it in the right place no matter how active your lifestyle might be. In SMBG, another large core platform, we recently launched the highly accurate and easy-to-use OneTouch Verio blood glucose monitoring system in Australia and Western Europe where it's been performing well. We look forward to upcoming launches of additional new products based on the Verio platform in the U.S. and Canada. In electrophysiology, which has been a consistent double-digit growth platform for us, we've taken share over the past year to the global launch of Carto 3, the most advanced navigational mapping system on the market today for treating cardiac arrhythmia such as atrial fibrillation. More recently, we've just begun the European launch of the ThermoCool SmartTouch Contact Force Sensing Catheter, a breakthrough technology that provides EPs with real-time information about the precise amount and direction of the force being applied during ablation procedures. Just last week, we enrolled the first patient in our pivotal U.S. trial for this product. We've been driving well above market growth in our biosurgicals platform through new products like the SURGIFLO Hemostatic Matrix Kit, one of the first product launches resulting from our 2008 acquisition of Omrix Biopharmaceuticals. We've also driven growth to the rapid globalization of the EVICEL Fibrin Sealant also acquired from Omrix. When we acquired Omrix, EVICEL is available in 1 country, Omrix's home country, Israel. But by the end of 2009, the product was available in 10 countries. And at present, we're at the 21 countries. In our ear, nose and throat platform, a great new platform, which we entered through our 2010 acquisition of Acclarent, we recently received U.S. clearance for the CYCLOPS Multi-Angle Endoscope. CYCLOPS is a revolutionary new endoscope that enables ENTs to visualize the anatomy of the nasal cavity like never before, so they can provide the best possible therapy. We believe that CYCLOPS will encourage and enable greater adoption of Acclarent's innovative Balloon Sinuplasty technology to treat chronic sinusitis, especially as these procedures begin to move into in office settings. Let's move to our second strategic priority, which is advancing our robust pipeline. Our financial strength enables us to invest approximately $1.8 billion a year in research and development. This is more than any of our competitors, and we're seeing our investment pay off. Last June, I showed you 2 charts highlighting significant products in the pipeline across our 7 franchises. Since then, I'm pleased to say that roughly 3 quarters of the products on these slides from last year have progressed from one column to the next. Products in the pending approval column have been approved. Products in the planned submission column had been submitted and so forth. I'll highlight just a few of these again by platform. Within our energy platform, Ethicon Endo-Surgery received 510(k) and CE Mark approval in just the past few weeks for its new advanced energy generator. This is the first of its kind combination generator that powers both ultrasonic and advanced bipolar technologies, helping to simplify the operating room and enabling surgical teams to dedicate more of their time to patients. We believe this a real game changer for our customers and for our business. Approval of this new generator paves the way for the launch of another important energy product that recently emerged from our pipeline. The new ENSEAL G2 Super Jaw device designed for open surgical procedures such as colorectal, gynecological and general surgery. This is the first bipolar advanced energy technology that offers surgeons strong seals while remaining gentle on tissue and it rounds out our product portfolio in this area. In our infection prevention platform, we just received U.S. clearance for the very innovative GLOSAIR Healthcare Environmental Decontamination System acquired as part of our 2009 purchase of Gloster Europe. The GLOSAIR System creates and uniformly disperses a fog of 5% hydrogen peroxide in hospital rooms and operating suites, hoping to reduce the risk of patient contact with infection-causing pathogens. Did you know, for example, that some light switches in hospital rooms, are cleaned only 20% of the time? Healthcare associated infections are a growing public health concern impacting an estimated 2 million patients a year in the U.S. alone. We believe the GLOSAIR System has a potential to become a real must-have technology for hospitals. In fact, in a survey that will be released next week, 75% of Americans say that it is more important to choose a hospital based on lower infection rates than on convenience when in a non-emergency situation. Insulin delivery is a relatively new platform for us. One of our most important pipeline products here is the Animas Vibe, an insulin pump that's integrated with a continuous glucose monitoring system, providing greater insight for pump wearers about their blood glucose levels. Unlike other CGM-enabled pumps, the Animas Vibe displays glucose trends in color, and it's waterproof, a fact that will be vividly demonstrated later this week when 6 Animas Vibe users swim across the English Channel to raise money for diabetes research. Additionally, the Vibe's Dexcom sensor technology is approved for up to 7 days of wear, delivering more days of CGM data than competing systems. I'm pleased to report that we and our partner, Dexcom, received CE Mark approval a few weeks ago for the Animas Vibe, and we continue to work together towards submitting the product for approval in the U.S. and Canada. Beyond the Vibe, I'm pleased to report that Animas received IDE approval a few weeks ago from the FDA to proceed with the clinical trial investigating the world's first artificial pancreas, an automated closed loop system that dispenses insulin based on real-time changes in blood sugar levels. We look forward to working closely with our partner, the Juvenile Diabetes Research Foundation, to begin feasibility studies on this groundbreaking project later this summer. Another new platform for us is sedation. As you know, we asked for and were granted an appeal from the FDA relating to the agency's denial of our PMA application for the SEDASYS system, the world's first computer-assisted personalized sedation system. We're hopeful that a new independent advisory panel will be convened before the end of the year to reconsider SEDASYS, a very exciting technology that has the potential to benefit millions of patients while removing cost out of the healthcare system. In the meantime, I'm pleased to report the system has been performing very well in Canada, where it is approved and now has been used in approximately 250 cases. Before wrapping up this portion of discussion, I should note that I've highlighted just a select few of the many products in our pipeline. We are advancing dozens of exciting new pipeline products, including several breakthroughs that I've highlighted to you in the past, such as the Fibrin Pad to address intraoperative bleeding and a contact lens embedded with an active anti-allergy ingredient. Moving to our next strategic priority, broadening our geographic presence, we really have a tale of 2 cities in this case between developed and emerging markets. Developed markets, the U.S., Japan, Europe are traditionally accounted for approximately 90% of the total MD&D market. So it's essential that we succeed in these markets, and we remain focused on growing our share there. As I mentioned earlier, growth in developed markets has slowed considerably over the course of the past 12 months. So we are increasingly shifting resources into emerging markets, which collectively are growing at a very strong double-digit rate and will make up a growing percentage of the total MD&D market moving forward. Now J&J is no newcomer to emerging markets. We opened our first offices in Russia nearly 20 years ago, in China nearly 30 years ago, in India more than 50 years ago and in Brazil more than 70 years ago. We understand what it takes to succeed in these markets, and we are succeeding. MD&D sales in China, for example, have grown twentyfold since 2000. We have achieved this kind of impressive growth even though we traditionally focused almost exclusively on the premium or as one segment in emerging markets. Those patients who live in urban centers and who can afford to pay out of pocket for top-quality health care. Moving forward, we plan to expand our coverage of the S-1 market in BRIC, as well as other promising emerging markets like Indonesia, Mexico, Turkey, to ensure that we are fully maximizing our growth potential. At the same time, we are expanding our product offerings to meet the unique needs of the S2 segment of the market, comprised of hundreds of millions of people who are now gaining some degree of healthcare coverage. I had the pleasure just a few weeks ago to attend the opening of a new MD&D Asia-Pacific innovation Center in Suzhou, China focused on developing product specifically for the S2 market in China and India. These products might be targeted at specific disease states that are more prevalent in the region. They might be simplified or smaller devices that are better suited for use outside the major cities and top-tier hospitals, or they might be multi-use or disposable products that are more economical. We already have a number of these products on the market, staplers, sutures, the blood glucose meter and an artificial knee, but there's much, much more to be done as we seek to bring the promise of good health to as many people as possible. And since so many of our products don't truly come to life until they get in the hands of skilled surgeons, we continue to provide training to thousands of physicians in both the S1 and S2 segment of emerging markets. Next week, for example, we will be opening a new DePuy Institute in southern India, modeled after the highly successful DePuy Institute we opened in the U.S. a few years ago. Osteoarthritis is on the rise in India, but today, joint replacement surgery there is performed at a very low rate, about 1/10 the number of cases per year compared with the U.S. even though India's population is roughly 4 times larger. Our institute in India will train approximately 1,000 physicians a year in the latest orthopedics techniques and technologies helping to ensure that patients can get the quality care they need. So I've taken you through our strategic priorities. Now I'd like to spend a few minutes talking about strategic portfolio management, ensuring that we are investing a disproportionate share of our resources, and those opportunities that we believe have the greatest potential to benefit patients and to drive our growth. I have often said that the business is like a garden. In order to thrive, it needs to be regularly pruned and planted. This type of work is important to do, even when the market conditions are favorable. But it's absolutely essential to do it in a tough market environment like the one we're experiencing today. We have a number of unique competitive advantages that really help us in this regard. The breadth of our businesses, not only in MD&D but across our pharma and consumer segments too, gives us a view of the entire healthcare landscape that enables us to make better choices than if we were in just a handful of market segments. We see the whole field, and we make our choices accordingly. Our breadth also enables us to leverage certain of our slower growth businesses and geographies in order to more aggressively fund higher growth opportunities. Our financial strength gives us the ability to invest in multiple growth opportunities at the same time rather than just having to pick 1 or 2. And our leadership position and reputation make us a highly attractive partner for companies across the spectrum of the MD&D industry, again, enabling us to pick and choose the best opportunities. We've made a number of important portfolio decisions in recent years. We've divested a few slow growth, non-strategic businesses such as our professional wound care and breast care businesses. And we've acquired a number of new businesses that have strengthened us in existing platforms or taken us into new areas, including Omrix in biosurgicals, SurgRX in energy, Mentor in aesthetics, Acclarent in ENT, Micrus in neurovascular, Finsbury in orthopedics and Gloster in infection prevention. Two significant portfolio moves we made this year are the decision to exit the drug-eluting stent business and the decision to acquire Synthese, a world-class orthopedics company. I'd like to spend a moment in both these decisions. First, we recently announced plans to stop manufacturing the CYPHER drug-eluting stent by the end of this year and to cease further development of the NEVO drug-eluting stent in order to better focus on those areas of the cardiovascular market with the most significant medical needs and the greatest opportunities for growth. Moving forward, our new cardiovascular care franchise will be comprised of Biosense Webster, the world's leading electrophysiology business, and Cordis, which will focus on access and diagnostic products for cardiology procedures and endovascular products to access and treat lower extremity disease. These businesses collectively generate $1.9 billion in 2010 sales and grew operationally at approximately 8%. I spoke with you earlier about our fast-growing electrophysiology business and some of the exciting new products that are driving growth in that space. On the Cordis side of the franchise, we received U.S. approval recently for the EXOSEAL Vascular Closure Device, which closes the puncture site made during catheterization procedures. This is an area where complications can occur and which can significantly affect length of hospital stay as well as patient comfort. EXOSEAL has done well in Europe where it's been available for about the past year, and we're excited about its prospects in the U.S. We also continue to advance a promising new device to treat abdominal aortic aneurysms, INCRAFT, which we expect to file for CE Mark approval later this year. An estimated 27 million people worldwide have abdominal aortic aneurysms. Left untreated, all aneurysms will eventually rupture resulting in death 80% of the time. The ultralow profile delivery system of INCRAFT has the potential to make endovascular aneurysm repair a possible treatment alternative for a wider range of patients. At the same time that we're bringing greater focus to our existing cardiovascular businesses, we'll also look for opportunities to enter in new areas of the market where we can significantly improve patient care and drive growth. Turning to another major portfolio decision. We announced in April a definitive agreement to acquire Synthese, a premier global developer and manufacturer of orthopedics devices. This agreement exemplifies our continued willingness and ability to take advantage of significant opportunities when they arise that will enable us to better serve more patients and to enhance our long-term growth prospects. The acquisition of Synthese would be the largest purchase in J&J history, and it is consistent with our enterprise global strategy that strengthen our leadership position across important healthcare markets, in this case, the $37 billion global orthopedics market. A combination of DePuy and Synthes we'll be well positioned to succeed in a time of dramatic change in the orthopedic market, offering patients, surgeons and hospitals a broad range of innovative technologies to meet their orthopedic needs. DePuy and Synthese are highly complementary. DePuy, as you know, is a leader in hips and knees, by far the largest segment of the orthopedics market, as well as in the sports medicine. Synthese is a leader in several important and growing market segments where DePuy has less of a presence or no presence at all, including trauma, cranio-maxillofacial and power tools. Both companies offer complementary portfolios for spinal surgery. Updating the status of the transaction, our integration planning activity is well under way. We've initiated several major regulatory filings, and we continue to expect the transaction to close in the first half of 2012. Let me also say that we continue to evaluate several alternatives to finance the transaction in the most efficient manner. Okay. Before we open up the lines for your questions, let me leave you with a few key takeaways. First, Johnson & Johnson is the largest, strongest player in the large, attractive MD&D market. Current headwinds are leading the slower market growth in the near term, but we remain confident in the market's solid long-term growth potential. Second, we are executing well against our strategic priorities. We are launching innovative products in our core franchises and in our high-growth businesses. We are investing in and advancing a robust pipeline, and we are strengthening our geographic presence. By doing so, we are gaining or maintaining share in most of the market segments in which we compete. Finally, we are committed to making the strategic decisions that will enable us to shape our portfolio, to best serve patients and to best drive our growth. I want to thank the thousands of MD&D employees around the world for their commitment to our credo, to the patients and customers we serve and to our business. And I thank all of you for your time and attention this morning. Now I'll turn things back over to Louise, who will get us ready for our Q&A session.