Boston Scientific Corporation

Good morning and welcome to the Boston Scientific first quarter 2022 earnings call. All participants will be in listen-only mode. Should you need assistance, please signal a comfort specialist by pressing star then zero on your telephone keypad. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then 2. Please note this event is being recorded. I would now like to turn the conference over to Lauren Tangler, Vice President, Investor Relations. Please go ahead.

Thank you, Andrew. Welcome, everyone, and thanks for joining us today. With me on today's call are Mike Mahoney, Chairman and Chief Executive Officer, and Dan Brennan, Executive Vice President and Chief Financial Officer. We issued a press release earlier this morning announcing our Q1 2022 results, which included reconciliations of the non-GAAP measures used in the release. We have posted a copy of that release as well as reconciliations of the non-GAAP measures used in today's call to the investor relations section of our website under the heading financials and filings. The duration of this morning's call will be approximately one hour. Mike will focus his comments on Q1 performance as well as future catalysts and the outlook for our business, including Q2 2022 and full year 22 guidance. Dan will review the financials for the quarter, provide more details regarding our Q2 and full year 2022 guidance, and then we'll take your questions. During today's Q&A session, Mike and Dan will be joined by our chief medical officers, Dr. Ian Meredith and Dr. Ken Stein. Before we begin, I'd like to remind everyone that on the call, operational revenue growth excludes the impact of foreign currency fluctuation, and organic revenue growth further excludes acquisitions and divestitures for which there is less than a full period of comparable net sales. Relevant acquisitions excluded for organic growth are Preventus, Faripulse, and Luminous Surgical, which closed in March, August, and September of 2021, respectively, as well as Bayless Medical, which closed on February 14, 2022. Investitures include the BTG Spec Pharma business, which closed on March 1, 2021. For more information, please refer to our financial and operating highlights deck, which may be found on our investor relations website. On this call, all references to sales and revenue, unless otherwise specified, are organic. This call contains forward-looking statements within the meaning of federal securities laws, which might be identified by words like anticipate, expect, may, believe, estimate, and other similar words. They include, among other things, the impact of COVID-19 pandemic upon the company's operations and financial results, statements about our growth and market share, new product approvals and launches, acquisitions, clinical trials, cost savings and growth opportunities, our cash flow and expected use, our financial performance, including sales, margins, and earnings, as well as our tax rates, R&D spend, and other expenses. Factors that may cause such differences include those described in the risk factor section of our most recent 10-K and subsequent 10-Qs filed with the SEC. These statements speak only as of today's date, and we disclaim any intention or obligation to update them. At this point, I'll turn it over to Mike for his comments.

Mike? Thanks, Lauren. Thank you, everyone, for joining us today. We're very pleased with our first quarter performance and our outlook for the full year, despite the impact of the ongoing pandemic and the macroeconomic headwinds. Growth in the quarter was fueled by improved procedure volume, our innovative portfolio, and strong execution across our global team. In first quarter 22, total company operational sales grew 13% versus prior year, while organic sales grew 10% above the high end of our guidance range of five to eight. Importantly, this performance was strong across all regions, and we anticipate that most all of our businesses grew at or faster than their respective markets. First quarter adjusted EPS of $0.39 grew 6.5% versus prior year, achieving the midpoint of our guidance range of $0.38 to $0.40. And despite continued macroeconomic headwinds and resulting supply chain pressure, first quarter adjusted operating margin was 25.8%, which is higher than anticipated due to the overachievement of sales and lower spend. While we continue to anticipate less of a global COVID impact on underlying procedure volumes for full year 22 versus 21, we're continuing to provide a wider guidance range to account for uncertainty related to COVID ways, staffing challenges, and supply chain pressures. However, we are increasing our full year 2022 operational growth to 9% to 11% and organic growth to 6.5% to 8.5%. For second quarter 22 revenue, we are guiding to operational growth of 6% to 9%, and organic growth of 3 to 6. We're also updating our full year 2022 adjusted EPS guidance to $1.74 to $1.79, and our second quarter adjusted EPS estimate to 41 to 43 cents. Despite increased macroeconomic pressures, we continue to target adjusted operating margin expansion of 10 to 50 basis points, or 26 to 26.4% for the full year. And Dan will provide some additional details. I'll now provide additional highlights in first quarter, along with comments on our 22 outlook. Globally, the impact from COVID varied by region during first quarter, and within the quarter, we experienced a more significant COVID impact in both the U.S. and Europe in January and early Feb, with significantly improved volume growth during the remainder of first quarter. Regionally, our businesses in the U.S. delivered operational growth of 13% versus prior year, which includes an approximate 400 basis point tailwind from acquisitions. First quarter performance in the U.S. was particularly strong in Watchman, PEI, cardiology, and endoscopy. In Europe, Middle East, Africa, we grew 12% in operational basis first prior year, while all businesses in the region experienced strong growth. We saw particular strength in structural heart, including TAVR, Watchman, and other interventional cardiology therapies, as well as electrophysiology. In Asia-Pac, we grew 14% operationally versus prior year, with new product launches fueling the region's growth, notably Polar Action Ranger in Japan and WaveRider Alpha in Australia. The China team delivered another impressive quarter with double-digit growth in the first quarter, with broad strength across the region enabled by a diverse portfolio. Given the current COVID wave in China, we do anticipate more pressure on underlying procedural volumes in the second quarter, However, we remain confident in our team's ability in China to continue to drive toward double-digit growth for the full year 2022. Now some additional thoughts on our business units. Urology and public health grew sales 7% organic and 16% operational. The global integration of the Luminous acquisition is going extremely well with an innovative MOSIS laser platform complementing our category-leading stone portfolio. Globalization remains a big opportunity in this business, and we're pleased with the approval of ReZoom in China after a successful pilot, and we look forward to launching later this year. Additionally, we received approval in Canada for LithiView Elite, which is our next-generation flexible single-use ureteroscope with advanced imaging and intrarenal pressure sensing capabilities. Turning to our endoscopy business, sales grew nicely, 9% organic versus prior year. The underlying business remains very strong, and we continue to innovate with new product offerings, supporting continued above-market growth. We're seeing momentum across our franchises, including biliary, hemostasis, and our single-use imaging franchise, as the Spyglass DS visualization system continues to have strong growth, while our newer single-use scopes are gaining scale. Beyond products, we're also enhancing our digital capabilities with the recent launch of e-commerce platform to all endoscopy customers in the U.S. based ambulatory surgical centers to enable easy online ordering from any device at any time. In neuromodulation, first quarter organic grew faster than the market at 8% versus prior year. In pain, we continue to see positive momentum in spinal cord stimulation as physicians continue to be pleased with the performance of the Waverider Alpha system with fast therapy and our cognitive practice optimization suite of solutions. In brain, we received FDA approval in the US for the neural navigator software with StimView earlier this month. This was developed in collaboration with BrainLab and enables more streamlined programming for clinicians with integrated visualization for lead placement and stimulation field modeling. In cardiology, organic sales grew 11% versus prior year, and operational sales grew 16, with all business units growing high single digit or better in the quarter. Within cardiology, our interventional cardiology therapies business had organic sales of 8% first prior year. Coronary franchise grew mid-single digits, fueled by new product launches and globalization. And within the quarter, we received FDA clearance of the expanded portfolio of the eMERGE PTCA dilation catheters, making it the only complete portfolio of balloon sizes in the US for the treatment of large vessels and lung lesions. We really had another strong quarter with double-digit growth in our structural heart valves franchise led by Accurate Neo2 in Europe. We continue to take market share in our existing accounts while also continuing to gain new accounts, exceeding our sales expectations in first quarter. Additionally, we have initiated and also are currently enrolling patients in our early feasibility study called Accurate Prime XL, which is evaluating additional sizes for the Accurate Neo2 valve. Turning to Watchman, organic sales grew 33% versus prior quarter, versus prior year. Watchman's on track to deliver full-year double-digit growth with sustained momentum from the second-generation Watchman Flex, ongoing clinical evidence, globalization, and commercial execution. Within the quarter, the ongoing surpass analysis of the NCDR LAO registry was presented at CRT. including more than 16,000 patients with real-world results that reinforce the differentiated safety and efficacy data seen in our Pivotal Pinnacle Flex Trial. In cardiac rhythm management, organic sales grew 7% and operational sales grew 14% versus prior year. In core CRM, we anticipate that our growth was in line to slightly above market with our low voltage business growing high single digits and our high voltage business growing low single digits. aided by stronger SICD sales. We look forward to the presentation of further clinical evidence at HRS later this week. Within the diagnostics franchise, we continue to be pleased with the performance of our differentiated portfolio with both the LUX-DX implantable cardiac monitor and Preventus AECG portfolio outpacing the market in first quarter. Electrophysiology sales grew 11% in organic 47% operationally versus prior year. International strength continues driven by our innovative portfolio and continued success of FerriPulse with late-breaking clinical data from the manifest PF survey presented at EHRA highlighting the real-world performance of the system. In more than 1,700 patients, investigators reported 99.9% success in achieving acute pulmonary vein isolation and excellent procedure times. We continue to further the body of clinical evidence elsewhere in the portfolio with real-world outcomes data from the PolarX ICE study, which was presented at EHRA, and demonstrated strong safety and efficacy of the PolarX cryoablation system. We also closed the Bayless acquisition in mid-February, and we're excited to bring a novel category-leading technology and commercial synergies to our broader portfolio. In peripheral interventions, organic sales grew 10% versus prior year. The arterial franchise was led by double-digit growth within the drug-eluting franchise, supported by ongoing clinical evidence and, more broadly, our category leadership portfolio. And within venous, Varathine had another quarter of double-digit growth, driven by a strong underlying market and penetration in new accounts. Our interventional oncology franchise continues to do very well, led by TheraSphere, which grew double digits in the quarter. And earlier this month, we received FDA IDE approval to initiate the Frontier study, which will assess TheraSphere as a treatment option for patients with glioblastoma, an aggressive cancer occurring in the brain or spinal cord. We also received FDA clearance for Embold, which is a fiber embolization coil that further enhances our portfolio of embolization technologies. Boston Scientific is dedicated to transforming lives through innovative medical solutions while also minimizing the impact of the environment and making measurable contributions to the world. Corporate responsibility is core to our values and helps inform our priorities that advance progress and align to our business goals. So we're excited to share our progress in the 2021 performance report, which we expect to release in May. Also in 2021, we announced five acquisitions, strengthening our underlying market growth with innovative technologies and accretive growth markets. In 2022, we evolved our leadership structure to enhance customer focus and further enable our strategies. Joe Fitzgerald now leads the cardiology segment, including interventional cardiology therapies, Watchman, CRM diagnostics, and electrophysiology. And Art Butcher now leads the med-surg segment, including endoscopy, urology, and neuromodulation, while continuing to oversee AsiaPAC. This new structure supports agile business practices and drives collaboration and innovation across our similar call points, while also empowering our leaders to maintain our deep customer focus. We're excited about the outlook of 2022 and our long-range plans, despite the macro and economic challenges we continue to face. We remain committed to our financial goals, growing sales faster than the market, continuing operating margin expansion, and double-digit adjusted EPS growth with strong adjusted free cash flow. I'm extremely grateful to our employees for their resiliency, their strong results, and their winning spirit. And I'll turn things over to Dan to review our financial performance in more detail.