Geoff Martha
Analyst · Evercore ISI
Okay. Thanks, Ryan. And I appreciate everyone joining us today. But before we dive into our Q1 results, I want to once again thank the frontline healthcare workers who continue to fight COVID-19 every day. We are thankful beyond words for your sacrifice and tireless resolve. I also want to acknowledge all of the Medtronic employees, who have gone that extra mile to support our customers and patients during this difficult time. Thank you for showing that our mission written 60 years ago, still inspires us and really defines who we are as a company. I also want to acknowledge the wildfires burning in Northern California. Medtronic has been a long time member of the Santa Rosa Community, and while our operations aren't currently affected, our thoughts are with those heroes battling these terrible blazes and the people affected, including some of our employees. We hope for a quick containment, and we're standing by ready to assist. Okay, now let's switch gears to Q1. Our results reflect a very strong recovery from the depths of the pandemic that we saw back in April. Procedure volumes began to recover this quarter in multiple markets around the world. And we drove market share gains in a number of our large businesses. Our revenue declined 17% on an organic year-over-year basis. And our adjusted EPS of $0.62, while down 51% was well ahead of expectations. We've seen a faster than expected recovery. Our pipeline is kicking in and we're increasing our cadence of tuck-in M&A. But most importantly, we're finding a new gear at Medtronic, and we're becoming a more nimble and a more competitive organization. And in the coming weeks, you're going to hear more from me on this topic, as we begin to outline the new Medtronic. When the pandemic first hit, we had to postpone our biennial Investor Day, originally scheduled for June. Well, today, we're announcing that we've rescheduled the meeting, and we're now going to host a virtual meeting with you on Wednesday, October 14. We're going to use that opportunity to lay out where we're headed, including a deeper dive on our pipeline now that it's coming to fruition, as well as the actions we're taking to simplify the company. So we look forward to being with you virtually at least on October 14. Now, I'd like to do something a little different than our past earnings calls, and lead with the discussion of market share. Collectively, our results in the month of June were stronger than many of our competitors, and that strength continued into July and now into the first few weeks of August. In some businesses, we're benefiting from the actions we took at the start of the pandemic, to better partner with our customers. In other businesses, we're seeing the benefit of new product launches, as our pipeline kicks in across the company. In fact, we've already had over 130 regulatory approvals this calendar year in the U.S. and Europe, Japan and China. We've included a key approval slide in our earnings presentation that outlines all of this. We're gaining share in our largest businesses like Spine and CRHF, Pacing and High Power. For example, our U.S. Core Spine business declined in the high-single-digits, which was better than the market. We estimate that we gained over a half a point of share in the second calendar quarter. Our differentiated offerings of enabling technologies, which includes robotics, imaging and navigation, combined with our implants is reshaping the spine industry. In CRHF, we estimate that we gained significant implant share in both the High and Low Power markets in the second calendar quarter, with the greatest gains coming in the U.S. Micra, our leadless pacemaker grew in the low-40s globally, and approximately 60% in the U.S. While many have been focused on how Micra is expanding the market and taking share, our new Cobalt and Crome, ICD and CRT-D platforms are also beginning to drive meaningful implant share in High Power. We launched these devices mid-quarter in the U.S. and we're now working with a growing number of providers across the country, who have not implanted with Medtronic in years. Electrophysiologists are choosing Cobalt and Crome for their unique AF and heart failure therapeutic algorithms. The high-40 joule output, extended battery longevity, heart failure management capabilities, as well as their blue sync remote programming and remote device management. These features provide layers of competitive advantage for us. We saw a 35% sequential increase in smart sync accounts globally. And our proprietary remote control programming technology, which was launched in the previous quarter, saw a six fold increase in adoption sequentially. In addition, utilization of our TYRX absorbable antibacterial envelopes increased by 9 points sequentially, to 50% of our U.S. transcatheter pacing and ICD implants, as hospitals are focusing on minimizing patient rehospitalization rates during COVID. We've also begun to return to sequential implants share capture and TAVR, one of our largest growth drivers. In the second calendar quarter, we maintained our share and market leadership in Europe, and gained approximately 1 point of implant share sequentially in the U.S., as we opened new NCD accounts and saw great response from interventional cardiologists and cardiac surgeons to the bicuspid, leaflet immobility and hemodynamic clinical data that was shared at ACC in the spring. In fact, we've received approval from the FDA just last week to remove bicuspid labeling limitations for low risk TAVR on the strength of these data. This labeling change complements the approval we received earlier this summer, as the only CE Mark TAVR system, with a bicuspid indication for intermediate risk patients. These are important regulatory milestones given the large size of the bicuspid patient population, including 60% of the low risk population. I'll also point out the share gains that we're seeing in our Pain Stim business, within neuromodulation, where we've been rolling out our new DTM therapy. The superiority data that we have for DTM is resonating in the market. We're taking advantage of this by focusing on customers that either don't use Medtronic devices, or split their business across multiple companies. And we're having great success with this strategy. In fact, almost half of our DTM implants in the quarter occurred with these type of customers. And equally important, our SCS trials, which are a predictor of our future implants, were ahead of our expectations and even caught up to prior year levels in June. This bodes really well for our Pain Stim business going forward. So while we're driving share gains in many important businesses, there are also areas that we need to improve. In DBS and Pelvic Health, while we lost share in the quarter, we're very bullish on where we're headed. In DBS, we received FDA approval for our Percept PC deep brain stimulation system with brain sense technology, in late June. Percept is the first DBS to record brain signals while delivering therapy, and we expect this to drive share gains in this high growth market going forward. In fact, we believe this is the beginning of a multi-year run in DBS, with our directional lead launching next year, followed by a Closed-Loop DBS system. We're redefining the standard-of-care and creating a significant technology gap between us and our competitors. In Pelvic Health, we just received FDA approval for Interstim Micro device, which has important features over the competition. Our device is 50% smaller, it recharges far faster. And importantly, the recharger doesn't need to be perfectly aligned for a successful charge. Additionally, Medtronic is the only company to offer physician practices, the choice of recharge and recharge free. And this is very important in the neuromodulation space. The physicians' feedback on our InterStim Micro rechargeable product has been universally positive. And there are several early indications that our share in the U.S. is rebounding quickly, much like we saw in Europe following the Micro launch earlier this year. In just a few weeks, we're winning back accounts and we're seeing cases where our competitors device is being explanted and replaced by Micro. We've been waiting for this. Patients now have the ability to choose a smaller, better rechargeable product. Physician practices to prefer to deal with one company. And our team is enjoying taking back the share. Finally, in diabetes, look, we're missing out on the better growth of this market, and nobody at Medtronic is comfortable with this dynamic. And we're pushing on several fronts to advance our technology. We're actively increasing both our near and our long-term growth opportunities, through increased organic investment, innovative funding with our recently announced Blackstone partnership, and inorganic activity, highlighted by the announcement earlier this month of our pending acquisition of Companion Medical. Companion Smartpen technology expands our ecosystem to include the multi daily injection portion of the diabetes market, with a patient population that is nearly 12 times larger than that that use insulin pumps. But make no mistake, we are still very focused on regaining technology leadership in the pump and the sensor market. However, we're also going to meet patients where they are, and provide them with real time data guided support. We expect to build a system that combines in pen with our Smart CGM technology, including our neutrino and clue artificial intelligence algorithms. All of this designed to deliver better outcomes and reduce the burden of managing the disease for MDI patients. See, Companion is just one more example of how we're going on the offensive as a company through an increased cadence of tuck-in acquisitions. In fact, in addition to Companion, we've done two other major tuck-in acquisitions this calendar year, with Digital Surgery and Medicrea. Combined, these three deals totaled approximately $1 billion in total consideration. Data and analytics are the next big frontier in surgery. That's why we acquired the pioneering technology company, Digital surgery, the leader in surgical artificial intelligence. We're integrating their technology into our soft tissue robotic assisted surgery system, and also intending to use their surgical video management and clinician decision support solutions beyond robotics. In fact, we plan on a limited launch this fall for the Touch Surgery Enterprise, which is an extremely easy-to-use, surgical video capture solution, paired with a computer and connected to the cloud. Medicrea, a pending acquisition we announced last month has differentiated technology that incorporates artificial intelligence into surgical planning for spine cases, and then uses the plan to create personalized spinal implants. With Medicrea, Medtronic will be the first company to offer an integrated spine surgery solution that includes AI-driven surgical planning, personalized implants and robotic assisted surgical delivery. This further extends our competitive advantage in Spine. We will continue to use the strength of our balance sheet to supplement our organic growth, and help drive increased and sustained revenue growth into the future. Next, let's turn to our pipeline, which is not just a share taking pipeline, it expands the total addressable market for Medtronic, as we intend to bring innovative technology to large healthcare opportunities, such as hypertension and cancer screening. So starting with our cardiac and vascular group, I've already mentioned the impact that our recent launches of Micro AV and Cobalt and Chrome are having in our CRHF division. But in addition to that, our next generation cardiac diagnostic LINQ II, received FDA approval in the quarter. And we began the limited U.S. release and expect the full market launch by calendar yearend. In our cardiac ablation solutions business, we started the European limited release of our Diamond Temp Cardiac Ablation system, with its unique closed-loop temperature-controlled RF system. And in June, our Arctic Front Advance Cryo system, became the first ablation system to receive FDA approval to treat patients with persistent AF. And this Saturday, results from our stop AF first trial, which studied our Cryoballoon as a first line treatment for paroxysmal AF, will be presented virtually as a late breaking trial at ESC. And in our coronary business, our Resolute Onyx Drug Eluting Stent became the first and only stent to receive CE Mark for one month DAPT treatment, for high bleeding risk patients. And we expect FDA approval for this differentiated labeling later this calendar year. In CVG, we also resumed a number of important clinical trials that were on hold due to the pandemic, including our pivotal trials for our extra vascular ICD, our Intrepid Transcatheter Mitral Valve, our PulseSelect Pulsed Field Ablation system, and our Symplicity Spyral renal denervation system. In our ON MED renal denervation trial, half of the sites have resumed enrollment, and we're aiming to complete the trial and present the data next calendar year. We're in the lead with Ardian, and this represents a multibillion dollar opportunity to better treat the millions of patients around the world, who suffer from hypertension. As I've already mentioned, we're now launching a number of products across the restorative therapies group, like the DTM spinal cord stimulator, our InterStim Micro sacral nerve stimulator and our Percept PC deep brain stimulator. Look, RTG is on a roll. And we expect these products to drive growth and take share going forward. And we intend to keep the RTG momentum going well into the future. We're making large investments in new products for neurovascular, for ENT and for enhancements to our Mazor X spinal robotic system. In diabetes, we continue to execute on our near-term pipeline. We're on track for the Minimed 770G approval later this summer. We've received CE Mark approval for our Minimed 780G, advanced hybrid closed-loop system and we'll launch this fall. We also continue to make meaningful progress on our sensor pipeline. Our U.S. pivotal trial for synergy is now underway. Enrollment is going well, and we're getting great feedback on this disposable sensor that is 50% smaller than our current product. In our Minimally Invasive Therapies group, we continue to make progress on bringing our soft tissue robotic system to market. Our final validation and verification testing is going very well. And our surgeon feedback continues to be positive. On the last earnings call, we told you that our timeline had been disrupted by COVID-19, but we've been managing through this and mitigating the impact to our timelines. In fact, we expect to be in a position to file for CE Mark and U.S. IDE approval in the first calendar quarter of 2021. Now COVID could change that, but we thought it was important to update you as to where we are today, and let you know that we have a high level of confidence as we move towards commercialization. In MITG, we've also been rapidly developing new solutions to treat COVID-19, including adding remote management capability to our Puritan Bennett 980 ventilator, integrating nalcor pulse oximetry sensors with label therms, closed-loop high flow ventilation system, and enhancing our vital sync remote monitoring solution to allow caregivers to remotely monitor our pulse oximetry and our capnography devices through a mobile application. Many of these features, they were developed in days and weeks, which in the past might have taken us months and quarters. But because we found new ways, we're moving faster. We're partnering with others, whether that's on technology development or in supply chain relationships. We're working with our regulators to ensure they have everything they need to streamline their decision makers, and our own people are stepping up across the company. As one example, we increased our internal ventilator production fivefold in a matter of just a few months, from 200 a week to over 1,000 a week. This is what I mean, when I say Medtronic is finding a new gear. We've been operating with a high sense of urgency, and we're going to carry this forward. I've discussed in the past how our organization needs to simplify and become less bureaucratic. In the coming weeks, you're going to hear more about the actions we're taking to become a more nimble and a more competitive organization, empowering our business units, while also allowing them to take advantage of Medtronic's global scale. I'm really excited about this direction. And I'm convinced that by empowering our general managers, we can become more competitive, we can accelerate our innovation, we can serve our customers better, and we're going to unlock a lot of value for our shareholders. So, with that, let me now ask Karen to take you through a discussion of our first quarter financials and our outlook. Karen, over to you.