Medtronic Plc (MDT) — Q4 2020 Earnings Call Transcript

Thank you. Good morning and welcome to Medtronic's fiscal year 2020 fourth quarter conference call and webcast. During the next hour, Geoff Martha, Medtronic Chief Executive Officer; Karen Parkhill, Medtronic Chief Financial Officer; and Omar Ishrak, Medtronic Executive Chairman, will provide comments on the results of our fourth quarter and fiscal year 2020, which ended on April 24, 2020. After our prepared remarks, we'll be happy to take your questions. First, a few logistical comments. Earlier this morning, we issued a press release containing our financial statements and the revenue by division summary. We also issued an earnings presentation that provides additional details on our performance. During today's earnings call, many of the statements made may be considered forward-looking statements and actual results may differ materially from those projected in any forward-looking statement given risks and uncertainties, including those related to the impact COVID-19 has had and is expected to continue to have on our business. Additional information concerning factors that could cause actual results to differ is contained in our periodic reports and other filings that we make with the SEC and we do not undertake to update any forward-looking statement. Finally, unless we say otherwise, revenue rates and ranges mentioned during this call are given on a constant currency basis, which compares to the fourth quarter after adjusting for foreign currency. References to organic revenue growth exclude the impact of our Titan Spine acquisition and currency. Reconciliations of all non-GAAP financial measures can be found in the attachment to our earnings press release or on our website at investorrelations.medtronic.com. With that, I'm now pleased to turn the call over to Medtronic Chief Executive Officer, Geoff Martha. Geoff?

Thanks, Ryan. And thanks to everyone for joining us today. I hope everyone is staying healthy and safe. And our thoughts are with the many people who have been affected by the COVID-19 pandemic. I'd like to recognize the incredible heroism, resolve, and sacrifice of the frontline healthcare workers fighting COVID-19, as well as our employees supporting them. Many of these frontline healthcare workers are our long-time customers and friends, and we are continually inspired by their selfless efforts to care for others. As has been said, this pandemic presented the world with an unprecedented challenge, which requires an unprecedented response, including from our team at Medtronic. I'm extremely proud of the way our employees have risen to the occasion and jumped in to help healthcare workers, governments, and NGOs, and for the way they've continued to support their communities and their families. Our top priority during this pandemic has been to ensure the health and well-being of our 90,000 employees and their families around the globe. Our employees have been impacted by this virus like everyone else. But I'm grateful for the way our people have continued to do their jobs and persevere through these challenging circumstances. Whether that employee is an engineer working on the next innovative breakthrough, in our factories making critical life-saving products, a field rep assisting a physician on the front line with a medical procedure, or any of our employees working virtually, we're all fulfilling the Medtronic mission. We've taken a number of measures in our facilities around the world to protect our employees. And importantly, we've continued to invest in our employees during this time, including implementing reward and recognition programs for business-critical on-site workers. We're also protecting our sales reps from significant impacts to their incentive compensation during this period. And we've developed an extensive emergency leave policy to provide temporary pay for employees who can't work remotely and are facing certain situations such as homeschooling, childcare issues, or a positive COVID-19 diagnosis. During the pandemic, we've been at the service of medical professionals and healthcare systems around the world, stepping up for physicians, hospitals, and health facilities that are on the frontlines. We've developed and rapidly deployed new remote procedure support and remote monitoring solutions to reduce patients’ and clinicians’ exposure to the virus causing COVID-19. We've hosted dozens of virtual forums and medical education programs to help physicians navigate the challenges of the pandemic. We've also worked tirelessly to ensure our products and therapies are readily available. The most visible example of these efforts is the work we've done to expand our ventilator capabilities and dramatically increase ventilator production. Physicians asked us if we could engineer a way to adjust ventilator settings remotely, outside of the ICU and away from the patient. So we partnered with Intel to develop a solution that we brought to the market in a matter of weeks. Furthermore, we're on track to increase our production of ventilators fivefold from pre-pandemic levels by the end of next month. We've enlisted the help of others to accomplish this, including SpaceX, who is working to supply a critical valve for our PB980. And we continue to closely partner with key government authorities to allocate our ventilators to the communities that need them most, including the recent focus on emerging markets. But we understood that simply increasing our own production volumes would not be enough. So we did what Medtronic does. Consistent with our mission, we put patients first. We decided to make our PB560 ventilator design specifications available at no cost, so other manufacturers can use these specs to manufacture ventilators during the pandemic. Through this initiative, we're creating partnerships with large-scale manufacturing companies such as Foxconn in the U.S., Baylis Medical in Canada, Vingroup in Vietnam, Walton Group in Bangladesh, and Tata Group in India. During this time of need, we've been supporting our communities. Since the start of the fourth quarter, Medtronic, along with the Medtronic Foundation has pledged more than $36 million in monetary and product donations to nearly 50 non-profit organizations to support health systems, patients, and vulnerable communities around the world. If you're interested in reading more on our response to our employees, our customers, and our communities, I encourage you to visit our website, medtronic.com/covid19. Now, let me turn to our Q4 financial results, which have suffered due to COVID-19. Our revenues declined 25% both constant currency and organic. This resulted in EPS of $0.58, which was down 52%. These results are in line with the press release we provided last month, where we discussed the expected negative impacts on our fourth quarter revenue resulting from a slowdown in procedures and the associated significant deleveraging that was expected to affect our earnings. They’re also consistent with the impacts seen across the industry. It's important to note that our quarterly results include an additional month of impacts in April when compared with the quarterly results of our competitors on a calendar year cycle. When we look at our Q4 revenue, the difference in our individual business results can be explained by four factors: The first was the mix of urgent procedures versus those that are more deferrable. Almost all of our businesses were affected by the decline in procedure volumes this quarter. Healthcare systems diverted their attention and resources to fighting COVID-19. Governments implemented restrictions on elective procedures. And people avoided taking treatment, even for emergency conditions. Our businesses that had a larger mix of products using urgent procedures saw an impact, but they were far less effected than those therapies where the procedure could be deferred longer. The second factor was a loss of large bulk purchases near the end of the quarter. As you can imagine the normal flow of these orders, which tend to be larger in April given our fiscal year end, did not materialize. As I noted on our last earnings call, prior to COVID-19, we were already planning to reduce large bulk orders and balance them across the quarter, starting with our next fiscal year. With the pandemic, our efforts were clearly accelerated. The third factor was centered around capital equipment. While capital equipment represents a small amount of our overall revenue, there are certain businesses that have a higher mix and felt the impact of hospitals and surgery centers delaying their capital evaluation and purchases. The last factor was the degree to which businesses’ products and services have played a role in fighting COVID-19, or had specific products and customers that were stocking ahead of the pandemic. This led to greater than expected growth in a select few of our businesses. So with these four factors in mind, let's look at our results by business group. Our Cardiac and Vascular Group declined 33%. CVG's therapies tend to overall be less deferrable. But we still saw substantial declines in procedure volumes. Moreover, CVG saw a greater impact than some of our groups from the reduction in bulk purchases with particular impact on CRM implantables, diagnostics, and transcatheter valves. Our Minimally Invasive Therapies Group declined 12%. MITG’s revenue mix is weighted more to the middle of the deferrable spectrum. So it did experience a significant impact from the decline in surgical volumes, particularly in the surgical innovations and GI, which both declined in the low-20s. This was offset by growth in Respiratory and Patient Monitoring, as well as in renal care solutions. In Respiratory and Patient Monitoring, which was up mid-teens, we saw significant growth in airways and ventilators as we sought to meet the COVID-19 related patient needs around the world. We significantly ramped production, which led to ventilator revenue nearly doubling. We also saw strong correlations in demand for pulse oximetry and capnography. But the increased demand was offset by overall reduced demand for patient monitoring products given fewer non-COVID-19 hospitalizations and procedures. Renal care grew high-single-digits driven by access catheters and acute and chronic dialysis products as dialysis treatment continued throughout the pandemic. Our Restorative Therapies Group declined 32%. RTGs therapies tend to be used in procedures that are more deferrable including those in Core Spine, Pain Stim, ENT, and Pelvic Health. RTG also was impacted by the reduction in customer bulk purchases and capital equipment purchases. RTG's neurosurgery business in particular has a high mix of capital sales. Our Diabetes Group declined 7%. The decline was driven by a delay in new patient starts on insulin pumps and due to the closing of physician offices as a result of COVID-19 as well as continued competitive pressure. This was offset by an increase in demand for diabetes supplies, including continuous glucose sensors and infusion sets, particularly in international markets. Next, let's review our fourth quarter performance by geography, which I think is a particularly helpful way to analyze our results given the progression of the pandemic to different regions throughout our quarter. First, China declined 38% and experienced the impact of COVID-19 for the entire quarter. Our revenue in China declined 46% in both February and March. We started to see gradual sequential revenue improvements midway through March and our April revenue improved to a decline of 21%. In Asia Pacific, our revenue declined 13%, as we saw the impact of the virus in many markets through the quarter, with the number of COVID-19 related cases peaking in some countries within the quarter. Korea declined 2% as COVID cases peaked in mid-March, and Australia/New Zealand declined 11%, with cases peaking in early April. Japan declined 14%, as cases continued to increase as we exited the quarter. In EMEA, our revenue declined 10%. Western Europe revenue was tracking with expectations through mid-March, when we started to experience significant declines. Revenue in Western Europe declined 32% in April, driven by procedure delays, and to a lesser extent, fewer customer bulk purchases. In the Americas, our revenue declined 32%, with the U.S. declining 33%, Canada down 24%, and Latin America declining 15%. Like Western Europe, our U.S. revenue was tracking with expectations through mid-March before experiencing significant declines, driven by a combination of procedure delays and the reduction of bulk purchases. Turning to our pipeline, we think about the impact of COVID-19 in three categories: products that just received regulatory approvals over the past few months; products under regulatory review; and products that are in clinical trials or preparing to enter clinical trials. Starting with the products that recently received their regulatory approvals, the pandemic has interrupted some of our recent launches, given the delay in procedures. This includes the European launches of our Percept PC deep brain stimulator, InterStim Micro rechargeable sacral nerve stimulator, Cobalt and Crome high power CRM devices, and the DiamondTemp ablation catheter. It also slowed the U.S. launches of our AV fistula indication in our IN.PACT Admiral drug-coated balloon, our DTM therapy in Pain Stim, and our Micra AV pacemaker. It's worth noting that prior to the pandemic, Micra grew over 60% in the U.S. in both February and March. The good news is that as procedures come back, we expect these launches to pick up steam. Moreover, we just received approval for Micra AV and our Reveal LINQ 2 cardiac diagnostic monitor in Europe, as well as U.S. approval for our Cobalt and Crome high power CRM devices, which we announced earlier this month. Our Cobalt and Crome offerings should be particularly valuable in the current COVID-19 environment, as they are the first and only Bluetooth-enabled high-power devices in the U.S. that allow for distance programming and better remote monitoring. Regarding the second category of products, those in regulatory review, the pandemic doesn't currently appear to be affecting the approval process. As a result, we're expecting a number of approvals this quarter, including U.S. approvals for our InterStim Micro sacral nerve stimulator, our Percept PC deep brain stimulator, and our Reveal LINQ 2. We're also expecting European approval this quarter of the Minimed 780G. In the U.S., we anticipate approval this summer of a new product we're calling Minimed 770G, which is Bluetooth-enabled and allows for wireless, over-the-air software upgrades, before we launch our 780G later in the fiscal year. In addition, 770G will be the first hybrid closed-loop system available to patients aged 2-6. Patients who purchase the 770G will get the free software upgrade to 780G with our Advanced Hybrid Closed Loop algorithm upon approval. We expect to show the pivotal results of our Advanced Hybrid Closed Loop algorithm in adults at the virtual ADA Conference in June. With the third category of our pipeline, those that are enrolling clinical trials or preparing to enter clinical trials, the pandemic has slowed things down, as clinical trial startups and enrollments have been placed on temporary pause. This includes our soft-tissue robot, products in our Diabetes CGM sensor pipeline, and our RDN ON MED trial. Regarding our soft-tissue robot, our ability to finalize system and pre-clinical testing has been delayed, and given the uncertainty of the pandemic, it's too early to update you on timelines. However, we're exploring ways to expedite this work, with the intent of minimizing the delay. In Diabetes, we continue to be optimistic about our ability to close the competitive gap in continuous glucose monitoring sensors. We intend to submit data to regulatory agencies on our Zeus transmitter at the end of the summer, and we have completed verification of our Synergy sensor that will enable our IDE submission within the next few weeks. And in renal denervation, we will combine our RDN ON MED data with our recently presented OFF MED data to support U.S. approval. Look, we are excited about creating the new renal denervation market with its potential to treat millions of patients with hypertension. With all of these recently approved and near-term pipeline products, customer enthusiasm remains high, and collectively, these represent growth acceleration as we emerge from the pandemic. With that, let me now ask Karen to take you through a discussion of our fourth quarter financials and outlook. Karen?

Thank you. As Geoff mentioned, our fourth quarter organic revenue declined 25%, and adjusted EPS was $0.58, a decline of 62%. We did have significant deleveraging down the P&L in the quarter, as we continued to invest for the future despite the lower revenue growth. Gross margin declined by approximately 700 basis points, driven in large part by increased expenses as a result of COVID-19, including manufacturing facility cleaning, increased protective equipment, bonuses for our factory employees, and higher freight and obsolescence charges. In addition, we experienced a negative impact from the mix, as products in higher demand carried lower margins. And we continued to experience a year-over-year impact from increased China tariffs. In addition to a lower gross margin, our operating profit was affected by continued R&D investment in our pipeline and continued spending in SG&A, as we purposely protected the variable compensation of our sales reps. Below the operating profit line, our adjusted interest expense declined 30%, driven by our successful debt issuance and tender transactions that we completed last spring and summer. And our adjusted nominal tax rate was 12.6% for the quarter and 14.3% for the year. Both were favorably impacted by lower earnings and the jurisdictional mix of profits. Excluding any non-recurring tax benefits we received in fiscal year ‘20, our adjusted nominal tax rate would have been approximately 15%. Despite the decline in earnings, we did not lose our focus on driving free cash flow. In fact, we generated $6 billion for the fiscal year, converting 97% of non-GAAP earnings, well above our long-term target of 80%. And our financial position remains strong. Over the past several years, we have made important decisions to maintain a healthy and robust balance sheet, which enables us to not only withstand significant disruption but more importantly, maintain our focus on the long-term. We have ample liquidity, with $10.9 billion of cash and investments as of the end of the quarter, and an undrawn $3.5 billion credit facility. In addition, we have no public debt maturing until March of 2021. As we stay focused on the long-term, we will continue to allocate our capital to drive our growth strategies, including investing in our pipeline to accelerate our long-term organic revenue growth. In addition, we have not slowed our business development activities, as we continue to look to supplement our organic growth drivers with inorganic opportunities, including minority investments and tuck-in acquisitions. We also continue to focus on generating proper returns for you, our shareholders, through both our organic long-term growth and our strong dividend. As an S&P dividend aristocrat, Medtronic has increased our dividend over the past 42 years, and this morning, we will make it 43 by increasing our annual dividend by $0.16. Looking ahead, the uncertainty of the COVID-19 pandemic makes it difficult to provide our traditional annual and quarterly guidance. Instead, we are happy to provide our thoughts on the recovery. As you know, there are many factors that will influence its speed and trajectory, and these will vary by geography and therapy. COVID case volumes and potential resurgence will certainly play a role, as will updates to recommendations from government agencies on the resumption of elective procedures and provision of non-COVID related healthcare. Hospital capacity will be another key factor. We recognize that new protocols designed to ensure patient and provider safety can slow the return to full capacity. And some healthcare systems are planning to increase capacity by extending workdays or doing procedures on weekends, though this isn't the case in all regions. Moreover, some hospitals are at this point maintaining surge capacity, in case there is a second wave. We are assuming that any potential second wave will be adequately contained, but we are watching this closely and are prepared for a range of scenarios. While it’s still early, we believe we have seen the worst of procedure declines and are seeing encouraging signs of earlier-than-anticipated recovery in several places around the world. In fact, the recovery has begun in China, although it is gradual. While the ultimate pace there is still uncertain, we've seen a reduction in our weekly decline in revenue over the first few weeks of May, with a high-teens decline from the prior year. In other parts of Asia, such as Japan and India, we are still experiencing severe year-over-year procedure declines, and we continue to expect lockdowns to impact our first quarter, while other markets like Australia, New Zealand, and Korea should continue to see recovery. In the U.S. and Western Europe, we've started to see sequential revenue improvement and hope to see that continue. In May, we've seen our weekly revenue across Western Europe declining around 20% from the prior year, and the U.S. has been declining around 30% over the same period. With all of this in mind, we currently expect first quarter revenue growth to be modestly worse than the fourth quarter for both the total company and each of our groups. To be clear, we are seeing encouraging signs in many geographies. But our largest regions are likely to experience a full quarter of impact compared with just 5 or 6 weeks in the fourth quarter. And at this point, we expect the second quarter to be better than the first, as the recovery continues, and sequential improvement through the remainder of the fiscal year. By the time we reach the fourth quarter, we would expect to be back to more normal revenue growth on a two-year stacked basis. Focusing on the first quarter, while there is still a lot of uncertainty regarding the recovery, we would expect RTG revenue to be the most challenged, followed by CVG, with both expected to decline more than the total company. MITG and Diabetes are both expected to decline in the first quarter as well; however, they should be better than the company average. And remember, we have an additional selling week in the first quarter, something that happens every 5 or 6 years with our fiscal calendar. Because this extra week occurred the last week of April, during the time the impact of the pandemic was at its highest, we picked up only a minimal amount of additional revenue. On the bottom-line, we continue to plan for significant deleveraging in the near term. We expect our gross margin to remain under pressure owing to product mix, lower volumes, and the extra cost of safety protocols. Where we have more than enough inventory to meet current demand, manufacturing plants may operate at less than full capacity, which could lead to period expensing of some fixed overhead costs. With this in mind, our first-quarter gross margin could be down a few points sequentially. As stated, we are not taking a short-term view when it comes to investment. We believe in the strength of the company and are positioning ourselves to come out of this crisis even stronger as we continue to invest in our employees, our pipeline, and our product launches. Given this, the first-quarter SG&A and R&D spend should be a couple of hundred million dollars higher than the fourth. Though, similar to revenue, we would expect operating profit to improve as we progress through the fiscal year. Regarding currency, the U.S. dollar has strengthened substantially since the pandemic began, especially against emerging markets currencies. As a result, our FX impact is looking to be about $0.10 more negative to fiscal '21 EPS than a few months back, and just over $0.20 for the fiscal year. Before I turn the call back over to Geoff, I would like to express my sincere gratitude to our employees around the world for their ongoing commitment to our mission. I couldn't be more proud of our teams and the way they have worked together to support our customers and ensure patients have access to our life-saving therapies. Back to you, Geoff.

Thanks, Karen. Now, looking back at what we've accomplished since the start of the pandemic, we are in many ways already a stronger company as a result of our actions. We've reaffirmed our mission in a profound way. When patients and healthcare workers urgently needed solutions that we couldn't provide alone, we turned to Tenet 2 of our mission for a path forward. Tenet 2 tells us to focus our efforts on biomedical engineering where we display maximum strength, but it also says to gather people and facilities that augment these areas. And we did just that, forming new partnerships that enhance our biomedical expertise with additional technology, supply chain reach, and manufacturing capacity from other companies. We've also gone back to our roots as a company by re-instilling the value of close partnerships with our customers. We're focused on our customers' needs during this pandemic, moving beyond just selling the best medical therapies to using our expertise to bring broader solutions to the table. Feedback from customers and governments on our support has been incredibly positive, and they are grateful for our efforts. And we're bringing these new solutions to market at record speed. Development timelines have been measured in hours and days, not weeks and months, and the output has been very impressive. This pace and impact has created a strong energy and spirit within Medtronic. Despite the day-to-day challenges of the pandemic, our people are really engaged and excited to assist customers in the recovery. So now, as the world begins to recover, we're focused on emerging from this pandemic even stronger. We're executing strategies and supporting investments that others in our industry, who are in a different financial position, have been unable to make. We're harnessing new partnerships, cutting through the bureaucracy and operating with a high sense of urgency and speed. We're also sharpening our competitive edge to drive an even higher level of performance. As we emerge, we expect these investments will be even more evident in our attraction and retention of top talent, and in the new products and solutions that we're offering physicians, patients, and healthcare systems. Now, for competitive reasons, I'm not going to get into the details of all of the actions we're taking. However, when you combine these new possibilities with our pipeline, I couldn't be more excited about the future. We will come out of this even stronger, and in doing so, create sustainable value for our shareholders and for society. Finally, as many of you know, this is my first earnings call as CEO, which also means that this is Omar's last earnings call. So I want him to say a few words. Omar?

Thank you, Geoff. And, this is my 36th Medtronic earnings call, so it was definitely time to turn the job over to someone else. And you're doing great. The past nine years have really gone by fast, and it's been a pleasure getting to know all of you in the investment community, whether that was visiting your offices around the world, hosting you in Minneapolis, or meeting you at the conferences. I sincerely appreciate all of the interest you've had in this company and in this industry, and the support that you've given me and the Medtronic management team over the years. As I look ahead, I have full confidence in Geoff and this leadership team to take the company forward. The team has been incredibly focused on the recovery and has a number of plans in the works. We're operating from a position of strength, given the strong financial position of the company and the full and robust pipeline. While I didn't expect to be turning over the CEO role during a pandemic, it's reassuring to know that the decisions that we've made over the past several years have prepared us for this time. I'm confident that we have the right engaged team in place to ensure that Medtronic emerges even stronger. As you've heard me say many times before, healthcare is a perpetual growth opportunity, as the three universal healthcare needs of improving clinical outcomes, expanding access, and optimizing cost and efficiency will not go away. The Medtronic mission and focus on these growth opportunities is enduring. I'm glad to have played a role in leading this storied company, and I'm sure its best days are ahead. I wish Geoff, the team, and all of our employees all the very best going forward. Geoff, back to you.

Thank you, Omar. And you didn't just play a role, you played a major role. And as you step away as CEO, you're leaving us well positioned to thrive. The list of your accomplishments is long and meaningful, but to list a few that come to mind when I think of your legacy: well, first you doubled the size of this company, and you inspired our global employees to think differently, to think bigger. And you're the only CEO other than our Co-Founder, Earl Bakken, to be inducted into the company's Bakken Society which is the highest technical honor at Medtronic. You've created value for our shareholders, you got our whole industry to focus on value-based healthcare, and importantly, you operationalized the mission in everything we do, which led to improving the lives of millions of people over the past 9 years. It's been a pleasure and an honor working with you and learning from you. Finally, I really appreciate all you've done to make this transition a smooth one, and I look forward to continuing to work with you in your Executive Chairman and Chairman of the Board roles. Before we start Q&A, I'd like to briefly note that we currently anticipate holding our Q1 earnings call on Tuesday, August 25th. We've also postponed our biennial Institutional Investor and Analyst Day as a result of the COVID-19 pandemic. This was originally scheduled for next month, and we'll let you know the date once it's scheduled. Let's now move on to Q&A. In addition to Karen, Omar, and me, we also have our four group presidents: Mike Coyle, Bob White, Brett Wall, and Sean Salmon, here to answer your questions. As usual, we want to get to as many questions as possible, so please help us by limiting yourself to one question, and if necessary, a related follow-up question. If you have additional questions, please contact Ryan and our Investor Relations team after the call. Operator, first question please.

Geoff, maybe we can start with what you were talking about at the end of the call, which is why you're so optimistic that Medtronic will emerge stronger. It's something we've heard a lot of CEOs mention over the past quarter earnings here. But Medtronic is actually doing stuff. You're paying employees, both your sales reps through this, you’re paying bonuses. To me, it seems like you're actually building culture during a really difficult time here. But maybe just give me your thoughts on why that's not just lip service, but something that will actually materialize Medtronic coming out of this pandemic?

Let me outline several components of the answer. First, it's important to highlight our financial position going into the crisis. Having a strong balance sheet significantly impacts our ability to navigate this situation proactively. The actions we took during the crisis, particularly in supporting our employees through benefits programs and safeguarding their incentive compensation, especially for our highly leveraged sales representatives in the United States, have been crucial. We implemented various safety measures to protect their health and alleviate anxiety during this challenging time, which has positively influenced employee morale. We are seeing strong early signs of recovery, and our employees are focused and prepared to move forward effectively. Innovation and commercialization remain fundamentally about people, and our focus on our customers has strengthened. We have spent considerable time engaging with our customers, shifting the conversation from simply selling our therapies to discussing how we can assist them through the pandemic and beyond. The dialogue with our customers has become more collaborative, with them referring to us as partners, which is what we aim for. We have developed several unique programs that we believe give us a competitive edge, focusing on patient confidence, safeguarding healthcare workers, and enhancing hospital productivity, all of which are gaining traction. Regarding our pipeline, we entered this period with a robust lineup and are experiencing many product approvals as we move forward. Recently, we've received numerous approvals such as those for our Micra and cardiac rhythm devices, Cobalt and Crome, and the LINQ 2 in Europe and the U.S. Our Cobalt and Crome devices are particularly valuable in the current COVID-19 scenario, being the first Bluetooth-enabled high-power devices in the U.S. that support distance programming and improved remote monitoring. In terms of products under regulatory review, the pandemic does not seem to be impacting the approval process, and we anticipate several approvals this quarter, including for our InterStim Micro sacral nerve stimulator, Percept PC deep brain stimulator, and Reveal LINQ 2 in the U.S., along with the expected European approval for the Minimed 780G. We also look forward to launching the new Minimed 770G this summer, which will be Bluetooth-enabled and capable of over-the-air software upgrades. This device will be the first hybrid closed-loop system available for young patients aged 2-6, with free software upgrades to 780G included. We are enthusiastic about the potential for our new renal denervation market to treat millions of patients with hypertension. With all of our newly approved and impending products, customer enthusiasm remains high, signaling growth acceleration as we emerge from the pandemic. Now, I will turn it over to Karen for a discussion on our fourth-quarter financials and outlook. Karen?

Thank you for the question, David. As Geoff mentioned, we are observing encouraging signs of recovery, especially in our key markets of China, the U.S., and Western Europe. However, I want to note that we anticipate a full quarter impact in Q1, unlike the five to six weeks we experienced in Q4. Therefore, we expect Q1 to show slightly slower revenue growth compared to Q4. That said, we are looking forward to improvement in Q2 and continued growth into Q3 and Q4. By Q4, we expect to return to more standard revenue growth, which we will evaluate on a two-year stacked basis due to challenging year-over-year comparisons. Regarding stocking and the additional selling week, that extra week occurred at the very beginning of our quarter, at the end of April, during a particularly low period, resulting in minimal revenue impact from it. We have mentioned since last quarter our plan to achieve more consistent revenue throughout the quarter and to decrease the number of full transactions. We will persist with this strategy every quarter this year, having made a solid start in the fourth quarter.

Yes, I think this is obvious, but I can't help myself from stating this that from a revenue perspective, in particular Q1 is markedly worse than Q4, because of the extra five to six weeks of impact, but we are seeing early signs of recovery. It may be too early to extrapolate that all throughout the year, but we're seeing faster than we anticipated, especially in Europe and U.S. And for sure Q1 is the trough.

Just two things I would love to comment on and I'll list them both upfront in the interest of time. So, one is, I apologize is a little short-term. I just want to dig a little deeper on your comments on the upcoming first fiscal quarter. I'm sorry if I missed this, but did you give a sense for what you're seeing in the month of May? Just trying to get a sense for what kind of improvement you're assuming from May to get to that total Q1 comment that you made? And then I was also wondering if you just may be offer us a quick comment on the upcoming diabetes data we're going to see at ADA. Because I know in the past, you have commented that you do expect a time in range of around 80%? And just wondering if that is still the case.

Yes, thanks, Bob. I'll just talk about the month of May quickly. We are seeing encouraging signs, and particularly as we look at our largest regions in China, the U.S., and Western Europe. In China, where we had stronger declines in February and March of around 46%, we said we saw April declines of around 21%. And now we're seeing declines in China in the high-teens. So, continued improvement there. And in Western Europe, where we saw declines in April of around 32%. In May, we're seeing declines of around 20%. So again, continued improvement in Western Europe. And in the U.S., the picture is a bit crowded when we look at April because of our bulk purchases, but we're clearly seeing procedural improvement across the U.S. And in May, declines of around 30%, just in the first few weeks of May, which is better than what we had in April.

To expand on that in the U.S., Karen shared the numbers. We're receiving messages from CEOs and purchasing personnel at major health systems indicating a quicker recovery than expected in many regions. They are essentially asking if we are prepared for what’s coming. There are two positive aspects to this: first, the encouragement we’re receiving; and second, that they are communicating these developments to us. However, the Northeast may take a bit longer to recover as there is a higher level of patient apprehension there due to the severe impact of the virus in New York and Massachusetts. In contrast, other areas of the U.S. are looking quite positive. This is why we anticipate Q1 to be our trial phase, and we are beginning with the lowest point, where we are starting to see hopeful signs.

As we sit back and look at the impact from COVID, it looks like the healthcare systems globally were unprepared to deal with a large scale respiratory pandemic. And now that appears that the worse is behind us, it might be certain to having discussions with countries about the infrastructure investment needed to deal with the next wave or next pandemic. So for example, widespread respiratory monitoring or ventilators. Thanks so much.

Thanks for the question, Pito. The answer to that is yes. Right now, we have a significant focus on emerging markets, particularly concerning COVID and other respiratory viruses. We are integrating our portfolio, which includes ventilation, capnography, SpO2, and monitoring capabilities, to enhance hospital capacity for patients in these areas. This approach involves demonstrating how these devices work together and providing solutions to countries that currently lack them and at the necessary scale. I believe this is not just a temporary measure; it will introduce these technologies to emerging markets and help make them a standard of care, as they are currently underused. Thus, I expect it will have a lasting impact. Bob, do you want to add any comments?

Yes. Geoff, just to build on what you said, and you said it really well. We think we’re really uniquely positioned with our combination of technologies and capnography, pulse oximetry, ventilation. An example of this is, we were a key player in standing up the Javits Center in New York City. And we think the opportunity as emerging markets, stand up ICUs and care theaters, that Medtronic will be there with them to do that. And as Geoff mentioned, we’re seeing tremendous interest from governments around the world as they look not only to stockpile and build their ventilation capability, but how they think about it because, while we’re seeing great recovery in the markets that Karen and Geoff mentioned, this pandemic is still going to hit emerging markets in a pretty big way unfortunately. And we want to be there to support it. So that’s it, Geoff. I think we’re really well positioned to capitalize on that.

Thanks, Bob. I’d like to mention that we have a business focused on remote patient monitoring, especially for patients with chronic conditions in the VA in the United States. This segment has seen an increase in interest, and we are strategically positioning it to better support patients during the pandemic in various ways.

I would like to discuss the TAVR franchise for a few minutes. It was somewhat challenging in the third quarter of the fiscal year. How has it progressed? What insights did you gather early on? Also, how do you view Dr. Popma’s new position? Congratulations on that hire as well. Thank you.

Well, Joanne, thanks for the question. Obviously, the issues in Q3, we talked about extensively on the last call, where we were very disappointed with the U.S. performance of TAVR given that we had procedural growth rates in, call it, the 14%, 15% range when the market was growing to double that, a little bit in the 30s. That was strictly a U.S. issue as you recall. We were actually growing with the market, a little ahead of the market outside of the United States. We talked a lot about how well we were refocusing sales forces and repositioning them back into large high-volume accounts where they had been basically being deployed into the start-up of new accounts with the NCD and increasing the sharpness of the messaging around our benefits of the super annular design that we have relative to better gradients and better hemodynamics. We were very encouraged, actually with where things were headed during the course of Q4 and the first half and those first seven weeks. We actually grew in the high teens. And in fact, as we were exiting that seven-week period, so the last three to four weeks there, we were actually well north of 20% in terms of procedural growth rate. Now while that’s still below the market, very good traction that we were seeing. And then obviously, in the last five weeks, six weeks of the quarter, obviously, we saw the impact of the pandemic hit that market pretty dramatically. Of course, the other benefit that we had was the ACC data releases, where we saw very significant positive data coming in the bicuspid area or immobility and lethal thrombosis data and some data that was a little more problematic for one of our competitors. So collectively, yes, we really like where we’re positioned in terms of pushing our messaging for our product and design. Obviously, the recovery is taking place currently now. And as Geoff mentioned, Karen mentioned, we are very encouraged by the trends that we are seeing in terms of now five weeks of continuous improvement in terms of overall procedural growth in that period. So we are encouraged with where things are headed. And we’re thrilled with the addition of Dr. Popma to our team. He is obviously one of the leading physicians in the area of structural heart and has just been instrumental in the support of our program over the years and guiding our program. And we think he will really help us with the messaging of our product for low-risk patients for bicuspid patients and in our clinical design and development. So we are very, very excited about where our TAVR program is headed.

Thanks Joanne. Next question please, Carmen.

I'll ask both of my questions upfront. You mentioned improvements seen in May across different geographies, but I'm interested in which segments are recovering faster and if there are any surprises. Is it more about emergent or elective procedures? Are we seeing a difference between inpatient and outpatient procedures? Do you expect these trends to continue in the upcoming quarters? Also, Bob, since it’s such an important product, could you provide more details about the delay with the surgical robot? I'm curious why COVID would cause a delay in pre-clinical testing. Are there adjustments being made that contribute to this delay? Should we consider this as possibly a couple of quarters' delay? How should we think about it right now? Thanks for addressing my questions.

Well, Larry, I’ll start with the first question and then ask Mike Coyle to add his thoughts, after which we’ll hear from Bob regarding the robot question. Concerning the recovery and procedures, I believe our recovery aligns with expectations. The more urgent therapies and products, such as neurovascular, RTG, TAVR, stents, and cardiac rhythm, are experiencing a faster recovery. In contrast, procedures that can be deferred, like our pelvic health franchise and RTG, are taking longer to bounce back. However, we’re seeing very promising data regarding cardiac rhythm for several reasons. Mike, could you elaborate on that for a moment?

Certainly. The procedures that we identified in our 8-K as being the least elective are returning to normal more quickly. In the cardiac surgery sector, ECMO has experienced significant growth, and pacemakers are also recovering swiftly due to the urgent needs of patients. This is especially true for Micra, which has shown a 60% reduction in complications related to pacemaker implants, helping to keep patients out of the ICU. Similarly, TRYX has seen increased usage to help patients avoid hospitalization. As Geoff noted, we are particularly encouraged by the recovery in the moderately elective technologies such as ICDs, CRT, TAVR, and coronary stents, which have shown a consistent rebound over the past five to six weeks. We’re also starting to observe positive trends in some of the less elective procedures, like atrial fibrillation and diagnostics, although these are recovering at a slower pace. Overall, what we've seen in the last five to six weeks is quite promising.

Yes, some of that is the market, and I think some of that, in the case of implantables or CVG implantables is how they’re positioned, with the remote capabilities, the distance programming, for example, and the lower complications, I think that’s helping as well, Larry. So maybe I’ll turn it over to Bob here for the robot question.

Yes. Thanks, Geoff. And Larry, thanks for the question. And certainly, as Geoff mentioned during his commentary, COVID has limited the pace at which we can really complete the required software system in pre-clinical testing. And Larry, this shows up in, I think, the impact in three ways. First, our engineers have been forced to work remotely, and thus really limited access to the hardware and the robotic system itself. Two, surgeons and OR staff have no ability yet to travel and participate in lab testing, and that’s had an impact; and then three, the availability of our external partners and sites to conduct some of the testing. As you know, as I’ve talked to you about previously, we have software development and testing centers around the world, all of which have had impacts on productivity. And then as I shared with you previously, we’ve certainly been working through the software development and integration challenges, that took us a bit longer and set us back as well. But the thing I would leave you with, our team is looking at every single creative way to expedite our work related to the program, and we’re seeing some amazing creativity. But true, as Geoff mentioned, given the uncertainty of the pandemic, it’s too early to give you an update on timelines at this point. But thanks, Larry.

Thank you, Larry. We have time for one more question, Carmen. Take the last question, please.

Hey, everyone. Thank you for having me, and Omar, congratulations on your time at Medtronic. I have a quick question for you, Karen. I think you mentioned that Q4 will return to normalized growth, and I'm curious if you look at growth from a double-stack perspective. Just to clarify, in Q4 of 2020, we saw a decline of 25%. Are you indicating that Q4 of fiscal year 2021 will increase by 25% or more, meaning that on a double-stack basis, we're back to growth? I would also like to ask, Geoff, about the pipeline. You mentioned InterStim Micro and Percept DBS. In a more normalized environment, what kind of market share gains or impacts can we anticipate from these products? Thank you.

Yes. So on your first question, Vijay, on what’s normal in Q4. Obviously, things are uncertain. And so we’re not giving specific guidance, because of that uncertainty. But just as we look forward right now, when we talk about a return to normal growth on a two-year stacked basis, we’re talking about normal around the mid single-digit levels. And so you can expect that on a two-year stack basis. Hopefully that helps.

Yes. It's Brett Wall with RTG. Regarding the new neuromodulation products, especially InterStim, prior to COVID in Europe where we introduced this technology, we regained 40% of the accounts we lost to competitors. We are very excited about this technology. It is extremely competitive. Every patient can undergo an MRI, whether it's 1.5 or 3 Tesla. The product also features excellent battery recharging capabilities, enhancing the patient experience significantly. The device is user-friendly, and it comes with a programmer that supports 11 different programs, allowing both the patient and physician to make numerous adjustments, unlike competitors’ simpler devices that offer limited flexibility, especially in a post-COVID environment. Regarding the Percept device, which we will also launch, both devices are set to be introduced this quarter in the United States, putting us in a strong position to gain market share. This is the first device capable of closing the loop with DBS procedures and monitoring brain activity, which will greatly improve the experience for the patient and the future of DBS overall. This represents a major reboot for our entire franchise.

Thanks, Vijay. Geoff, do you have any final remarks for us?

Okay. Thanks, Ryan. So on behalf of our entire management team, I’d like to thank you for your continued support and interest in Medtronic. And hey, look, we look forward to updating you on our progress on our Q1’s earning call in August. And so please stay healthy and safe.