Michael F. Mahoney
Analyst · RBC Capital Markets
Thank you, Michael, and good morning, everyone, and thanks for joining us this morning. So I'll begin today with some comments regarding our fourth quarter performance, which Jeff will cover in more detail in a few minutes. Overall, we demonstrated improved performance during the quarter. We delivered sales of $1,821,000,000, down 1% on both a reported and an operational basis, which excludes the impact of foreign exchange and the divested Neurovascular business. This was above our guidance range and Street consensus. Meanwhile our adjusted EPS of $0.18 was at the higher end of our guidance range and above Street consensus. We also generated strong operating cash flow of $370 million and used a portion of our cash flow to buy back approximately 18 million shares of stock in the quarter. We saw a continued above-market growth in several of our businesses. And the growth figures that I'll highlight are all on a constant currency basis. So starting off. Neuromodulation grew at 14%, Endoscopy grew at 10% and our Peripheral Interventions or our PI business grew at 9%. We also continued to see strong returns on our investments in the emerging markets with combined revenue in Brazil, Russia, India and China growing 35% in the quarter. As we further build our capabilities in these countries, we expect this growth trend to continue into 2013. We continue to make progress on strengthening our CRM and EP business with the U.S. launch of the S-ICD System and the completion of the acquisition of Rhythmia Medical. Additionally, we continue to expand the high-growth adjacent markets such as hypertension by completing our acquisition of Vessix Vascular. So let me now go into more detail regarding our business performance for the quarter. In the Interventional Cardiology or IC market, global PCIs continue to grow mid-single digits with growth in international markets offset by declines in the U.S., which, combined with global pricing dynamics, are yielding a global market that we believe is declining in low to mid-single digits. During the quarter, IC revenues declined 9%. While we're disappointed in our lack of growth, we believe that our U.S. DES share is stabilizing and we were able to grow international DES revenue mid-single digits. In the U.S., our PROMUS Element Plus long-length stents have been well received and we expect them to provide access to more competitive accounts as those accounts come up for contract renewal. We estimate our fourth quarter U.S. DES share to be in the mid-30s. And in terms of our U.S. -- I'm sorry, in terms of our DES pipeline, our next generation of SYNERGY Stent continues to progress according to plan with CE Mark Approval received in late October and a controlled limited launch currently underway in Europe. The early feedback from customers has been very positive. And further, we commenced our SYNERGY U.S. IDE trial called EVOLVE II and enrollment is tracking on schedule. Also, our launch of PROMUS Element Plus long lesion and small vessel stents in Japan has delivered solid share gains in that market. So with our PROMUS and SYNERGY platforms, we believe that we have the most compelling DES portfolio and pipeline in the industry as backed by clinical evidence. And the continued focus on commercial execution of our overall IC pipeline and the continued favorable clinical evidence of our DES platforms, we believe that we will stabilize our DES share in the first half of 2013 and grow our DES share in the second half of the year. In our core IC business, we improved our performance sequentially. We continued the launch of the Emerge balloon catheter during the quarter and we've continued to receive positive feedback from customers. In addition, we commenced our commercial rollout of the BridgePoint Medical suite of coronary CTO devices that add to our unique and clinically differentiated portfolio of IC products, all of which enable us to be uniquely positioned to provide treatment for complex PCI procedures. On the structural heart front, we continued to make progress in TAVR with the Lotus Valve. Lotus is a differentiated, second-generation valve that is fully repositionable and recapture-able post deployment. At TCT, favorable 3-month data from the REPRISE I trial were presented. And we expect to complete REPRISE II in the first half of 2013 with projected CE Mark approval and European launch of the Lotus Valve to occur in the second half of 2013. So moving on to our PI business, Peripheral Interventions. PI delivered strong growth of 9%, resulting from a cadence of new product launches. We continued to see growth around the world with the U.S. and Asia Pac regions showing double-digit growth during the quarter. And this year, we're very excited to announce the acquisition of Vessix Vascular, which closed in the fourth quarter. This technology is a second generation of renal denervation platform for the treatment of uncontrolled hypertension. This platform is highly differentiated and it accelerates our entry into what we expect to be a multibillion-dollar market in the next 5 to 10 years. We expect to launch this platform commercially in Europe and other international markets in the second half of 2013. Overall, we believe that the end markets in PI are healthy, they're growing mid-single digits and we will continue to drive above-market growth both in the U.S. and globally in 2013. In Endoscopy, we had a strong quarter with 10% growth worldwide. During the quarter, several of our key product franchises in Endo experienced strong growth, namely our biliary, biopsy, metal stents and hemostasis franchises. Also, effective January 1, 2013, Category I CPT codes are now in place for the Alair platform, which is our bronchial thermoplasty system. This is a major reimbursement milestone for BT and we believe it also reflects the strength of the clinical evidence and the growing support for this procedure among pulmonary physicians. We expect those codes to provide greater access for treatment for patients with poorly controlled, severe asthma, it'll facilitate easier claims processing and accelerate private payer's coverage of this important treatment option. In the quarter, we surpassed our year-end goal exiting 2012 with approximately 230 sites and 18 countries using our BT platform. Overall, we believe that the end markets in Endo are healthy, and we will continue to drive above-market growth on a global basis in 2013. In our Urology and Women's Health division, we returned to growth with a 3% increase during the quarter. The Urology business continued to perform very well with strong growth due to our commercial expansion and effective product launches. Our Women's Health business continues to be pressured, particularly in the U.S., due to the market declines in the pelvic floor procedures. In 2013, we have a strong pipeline in Women's Health and Urology with 7 expected new product launches. And in addition, we plan to continue expanding the global footprint of this business. In Neuromodulation, we delivered 14% growth during the quarter and we now have a clear #2 position in spinal cord stimulation in the U.S., driven by a leading technology and excellent consistent execution. We recently launched the Precision Spectra Spinal Cord Stimulation System in Europe. Precision Spectra is the industry's first 32-contact spinal cord stimulation system offering several market-differentiating features that are designed to provide clinicians with greater flexibility in treating the broadest spectrum of pain patients. We are pleased with the physician enthusiasm that Spectra has received, and we expect the launches in the U.S. in the first half of 2013. So now, let's move to the CRM business. Our worldwide CRM business declined 4% during the quarter, and we believe that the worldwide CRM market continued to show signs of stabilization during the quarter, declining to low to mid-single digits for the full year. In the U.S., we continued to see the easing of year-over-year comparisons as we sunset the significant 2011 market declines. In the U.S., we estimate the defib market decline in the mid-single digits in the fourth quarter. And from a share perspective, we estimate that overall U.S. de novo defib share continue to increase sequentially, thanks to the continued strong performance of our INCEPTA and ENERGEN family of ICDs and our highly reliable RELIANCE lead platform. In addition, sales of our RELIANCE leads remain strong in the quarter, driving continued increase of our defib lead-to-port ratio. So now, let's turn to our innovative S-ICD platform. So during the fourth quarter, we continued to manage a controlled launch of the S-ICD System. We are continuing to enhance our supply chain to meet the very strong clinical demand for this technology that follows early FDA approval. We believe that the growing demand for the S-ICD highlights the strategic importance of this innovative technology for patients and to our CRM business. We believe that the S-ICD technology provides us with the opportunity to both take share in the existing ICD market and to expand the market over time. Also, the recently announced results of the 1,500 patient MADIT-RIT trial highlights the potential of the S-ICD. This trial demonstrated that very simple ICD device programming with limited antitachycardia pacing and relatively long delays before giving therapy resulted in significantly better outcomes for participating patients. And thus, simple programming, limited pacing at longer delays before therapy are all design features of the S-ICD. On the pacing side, we believe we've taken modest share both in the U.S. and internationally with our INGENIO family of pacemakers and CRTPs, thanks to an upgraded platform that now includes wireless telemetry, RPM-enabled devices and other significant new design features. In terms of our pacer pricing, our pricing has remained relatively stable versus last year, thanks in part to price uplifts we realized on this new platform. Now, turning to left atrial appendage. The WATCHMAN product line continues to show strong growth in international markets, both on a sequential and year-over-year comparison. Specifically, WATCHMAN implants in the fourth quarter grew by more than 65% year-over-year. And finally, in our EP business which grew 5% during the quarter, we're focused on making good progress on several new internal AFib-focused projects. We have CE Mark for our Blazer Open-Irrigated Catheter, and we are currently enrolling 2 IDE trials for approval of the open-irrigated Catheter in the U.S. BLOCk-CTI study for AFib -- I'm sorry, for atrial flutter, and ZERO-AF for atrial fibrillation. In addition, we're excited about the recent acquisition of Rhythmia Medical and its next-generation mapping and navigation solutions. This acquisition is a decisive step by Boston Scientific and it shows our commitment to the Electrophysiology business and better positions the company to participate in the fast-growing EP market. So we expect CE Mark approval of Rhythmia platform in the first half of 2013 with FDA approval in the second half and a full EU and U.S. launch in 2014. So to wrap up the rhythm management section. We believe that the combination of the S-ICD, WATCHMAN and newly rejuvenated pacing and ICD platform, combined with a stronger EP and mapping portfolio, will provide BSC a truly differentiated offering for EP that we expect to improve our future growth profile. So in summary, in 2012, although we're encouraged by our performance in the fourth quarter, we're clearly not satisfied. Overall, 2012 was a challenging year in terms of top line performance. However, we were successful in hitting our adjusted earnings for the year and continued to generate significant adjusted free cash flow. So despite these challenges, we believe that there's a lot to be positive about: we continue to see above-market growth in several of our businesses; we expanded our capabilities in emerging markets; and we began to see some encouraging signs of stabilization in our core IC and CRM markets. We're also encouraged by the recent progress we've made on strengthening our largest core businesses with the early launch of the S-ICD System in the U.S., the acquisition of BridgePoint in the CTO device segment and CE Mark approval for our next-generation stent system called SYNERGY. We've also seen continued strategic push in the higher-growth adjacent markets by acquiring Vessix Vascular for the treatment of hypertension and Rhythmia Medical for mapping and navigation. So finally, we continued our share repurchase program and now bought back 12% of the outstanding shares of the company in the last 18 months. So taken together, we believe that our progress in '12 puts us in a stronger position going forward and will lead to improve shareholder returns, particularly given our current stock price valuation. So before moving to 2013, I want to highlight our new strategic imperatives and provide an overview to the changes being made right now to strengthen our global execution. These imperatives will be used to guide the company going forward. So first, we plan to improve our execution to increase share in our core markets by adding new capabilities and innovation to drive clinical and economic value to our customers. Secondly, we're entering new and faster-growing adjacent markets. We're leveraging our current capabilities, including our global manufacturing, clinical and sales organizations to grow in these markets. Third, we're driving global expansion through a strong and continued focus on our international markets, including the BRIC countries and other emerging markets. And fourth, we plan to fund our growth strategy and improve margins by focusing on continuous improvement and following a disciplined approach to restructuring as evidenced by today's announcement, which Jeff will discuss in more detail later. Lastly, we continue to develop new capabilities and programs for our employees to compete and lead in the shifting global med tech environment. Now, I would also like to highlight the important leadership and operational changes that we're already making and will continue to work on as we strengthen our global execution. Number one, we're moving a global operating structure across our business units. We believe this structure will enable us to operate more efficiently and effectively by improving our speed in global resource allocation. Two, we're streamlining our commercial sales model, both in the U.S. and Europe, by reducing layers and complexity. We're also building a stronger corporate solutions organization to meet the demands of the large integrated health networks and emerging accountable care organizations. We strengthened our leadership team with a number of important organizational changes and experienced hires across the company. And we continue to strengthen our focus on emerging markets that's demonstrated by our plus-30% growth in 2012. We're shifting more of our R&D dollars into higher-growth markets and we're improving the leverage of our R&D capabilities across the company to unlock more synergies and growth opportunities. And lastly, we continue to be focused on continuous improvement and scaling back our corporate infrastructure to reduce costs and improve our overall speed. We believe that these actions taken together demonstrate that we're thinking differently and acting decisively to improve our global execution and growth profile. So with that, I'll now offer some comments regarding 2013, which Jeff will cover in more detail. So as we look forward in 2013, we expect improved global execution and improved revenue and earnings performance. So with respect to revenue growth, we're projecting a range of negative 2% to positive 2% growth and we encourage you to model at the midpoint. We expect a slower first quarter with sequential improvement throughout the year, ending with a return to growth in the second half of 2013. Looking across the company, we expect to see continued above-market growth in our PI and our MedSurg businesses, which consist of our Endoscopy, Urology and Women's Health and Neuromodulation divisions. We expect to see continued growth in the emerging markets, driven by accelerated top line performance in the BRIC countries. And lastly, we believe that our IC and CRM businesses will deliver improved performance versus 2012 and we expect to grow our market share in the second half in those businesses in 2013. We expect to continue to drive our continuous improvement and restructuring initiatives while we invest in our strategic growth initiatives. We believe that the first half of 2013, and particularly the first quarter, will be a more challenging from a top line perspective due to tougher 2012 comparisons, primarily driven by competitive pressures in DES and the impact of fewer selling days in the first quarter. We expect to continue delivering on our continuous improvement opportunities to reduce costs and boost our overall speed. Unfortunately, we will also need to absorb the impact of the medical device tax under the U.S. Affordable Care Act that begins in 2013. And with respect to operating margins and earnings, our 2013 EPS range is $0.64 to $0.70. At the midpoint of our guidance range, we're projecting a low single-digit adjusted EPS growth, but this includes the full impact of the medical device tax. Lastly, we expect to generate strong cash flow, which we believe would enable us to fund more share purchases under our newly authorized $1 billion program and to continue to look at acquisitions to improve our future growth profile, which we expect will enhance shareholder return. So in summary, we believe the steps we are taking are what's needed to turn around our performance and return Boston Scientific to growth. We plan to go into greater detail during our upcoming Investor Conference, which will be February 12 in New York City. Let me now turn the call over to Jeff.