Medtronic plc

Good morning and welcome to Medtronic's Fiscal Year 2021 Fourth Quarter Earnings Video Webcast. I'm Ryan Weisfenning, Vice President and Head of Medtronic Investor Relations. Before we start the prepared remarks, I'm going to share with you a few details to keep in mind about today's webcast. Joining me today are Jeff Martha, Medtronic Chairman and Chief Executive Officer, and Karen Parkhill, Medtronic Chief Financial Officer. Jeff and Karen will provide comments on the results of our fourth quarter and fiscal year 2021, which ended on April 30, 2021. After our prepared remarks, we'll take questions from the sell-side analysts that cover the company, and today's event should last about an hour. Earlier this morning, we issued a press release containing our financial statements and divisional and geographic revenue summaries. We also posted an earnings presentation that provides additional details on our performance. The presentation can be accessed from the link in our earnings press release or on our website at investorrelations.medtronic.com. As we mentioned last quarter, the fourth quarter marks the first time that we're using the new nomenclature and reporting structure of our new operating model. For more information on these changes, please see the relevant slides in our earnings presentation. During today's webcast, many of the statements we make may be considered forward-looking statements, and actual results may differ materially from those projected in any forward-looking statement. 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. Unless we say otherwise, all comparisons are on a year-over-year basis, and revenue comparisons are made on an organic basis. Fourth quarter organic revenue comparisons adjust only for foreign currency, as there were no acquisitions or divestitures made in the last four quarters that had a significant impact on total company or individual segment quarterly revenue growth. Full fiscal year organic revenue comparisons exclude the impact of foreign currency, the benefit in the first 12 months of our tight and spine acquisition, and the benefit of the extra week in our first quarter. References to sequential improvement compared to the third quarter of fiscal 21 and are made on an as-reported basis. All references to share gains or losses are on a revenue and calendar quarter basis, unless otherwise stated. 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. And finally, our EPS guidance does not include any charges or gains that would be reported as non-GAAP adjustments to earnings during the fiscal year. And with that, let's get started.

Hello, everyone, and thank you for joining us today. We reported a strong quarter this morning. The expectations that we set for Q4 on the last earnings call were seen by many in the financial community as aggressive. Yet we executed and we delivered, beating street estimates on revenue, margins, and EPS. Most of our end markets are returning to near normal pre-COVID growth. While some geographies are lagging due to COVID's persistence, momentum built throughout the quarter and we feel confident about the year ahead. Karen will give you more color on our guidance later in this call, but the key takeaway is that we're guiding above street estimates on the top line while simultaneously accelerating our investments at the front end of major product launches in surgical robotics and renal denervation. Now, in robotics and renal denervation, we're investing in our marketing, customer service, and support capabilities to maximize these product launches. We're also investing in R&D broadly with meaningful programs across the company. As we talked about at our Investor Day last year, we have a packed pipeline across our businesses with a number of meaningful opportunities. And our top priority is to invest in our business and pipeline to take advantage of those opportunities. As a result, we plan on increasing our R&D spend by more than 10% in FY22, the biggest dollar increase in R&D spend in our company's history, all while delivering strong EPS growth. We're ultra-focused on accelerating our top-line growth, and we're making incremental investments to put us in a place to drive a sustainable, higher level of growth than you've historically come to expect from Medtronic. Before I get into some details on the fourth quarter, I'd like to reflect on the past year, my first as CEO. It's certainly been a difficult environment with the pandemic, but our organization has risen to the challenge and achieved so much in such a short period of time and under unique circumstances. Now it's become cliche for companies to say that they're expecting to emerge from the pandemic stronger, as I've heard this phrase echoed for many of our competitors. But you've been hearing this from us from day one. And I think you'll find it hard to name another company in our space that has done more to emerge from this pandemic stronger than Medtronic. Whether it was investing in our employees, helping our customers and patients, sustaining our R&D programs, or changing our operating model and putting in place a new Medtronic mindset culture, this past year was transformational for us. In fiscal 2021, customers eliminated the vast majority of their quarter-end bulk purchases, resulting in a more balanced order flow across the quarter. This has improved our predictability and our pricing, made our business easier to manage, and reduced stress on our operations. This past fiscal year, we also accelerated our tuck-in acquisitions, adding key technologies like AI-driven spine planning tools from MediCrea and market-leading SmartPen technology from Companion Medical, among others. We also advanced our organic pipeline with more than 230 regulatory approvals in the U.S., Europe, Japan, and China in FY21. FY21 was also the year that we stepped up and helped our customers and communities during the pandemic. As a leading manufacturer of high acuity ventilators, we significantly increased our production and open sourced our IP to allow others to produce our ventilators around the world. We continue to support communities in need, most recently as a key member of the Global Task Force on Pandemic Response, which was organized by the US Chamber of Commerce and supported by the Business Roundtable. With the help of other task force members, we're working to supply 1,000 ventilators to India. Medtronic and the Medtronic Foundation also just announced an additional $3 million for COVID relief efforts in underserved areas of India, Brazil, and the U.S., and other regions, which brings our combined support of COVID-19 efforts to $56 million. And in FY21, we announced our goal of becoming carbon neutral in our operations by the end of the decade. We've set aggressive targets to reduce our environmental footprint as we focus on creating a sustainable future for our business, our communities, and our planet. We've always had a strong mission to guide this company, which includes integrating a strong corporate purpose into our strategy and maintaining good citizenship. And this year, we've enhanced our corporate culture to emphasize our commitment to being bold, more competitive, and moving with greater speed and decisiveness, which we believe will help drive the execution of our mission. We're also focused on becoming a more diverse and inclusive organization. And I was very proud that Medtronic was recognized earlier this month as number 11 on Diversity Inc.' 's top 50 U.S. companies for diversity, one of the biggest jumps by any company. We know we have room to improve, and we're striving to be a company that attracts, develops, and retains top talent from all gender and ethnic backgrounds. To sum up F21, it was a year marked by progress and accomplishments that will propel us into FY22 with a stronger foundation for growth and a greater ability to execute, deliver, and exceed our own expectations. We have momentum, energy, and a pipeline that gives our team optimism about what we can accomplish this year. Now let's turn to the fourth quarter results and start with a look at market share as we've been doing the last few earnings calls. We continue to gain share in an increasing number of our businesses driven by our differentiated product offerings. And we've put in place operating mechanisms to ensure that we continue to drive this competitive culture across the organization. Market share is one of the key metrics that we will hold our teams accountable to deliver in evaluating performance, and in FY22, it will be included as a metric in our annual incentive compensation. While the impact of COVID on procedures, along with the timing of our quarter, does mask some of the underlying market dynamics, we are seeing a growing trend of share gains for Medtronic. Leading the list for share gains this quarter is one of our largest businesses, cardiac rhythm management, which has gained share over the past several quarters. We estimate that our CRM business has gained two to three points year over year. And CRM is now at the highest share level in more than a decade, with strong gains from around the globe. Now, these gains have been driven by Micra, our leadless pacemaker, which grew 74% in Q4 and is now annualizing at nearly $400 million. Micra is a great example of the innovation and disruption that we're driving at Medtronic. But it's not just Micra generating our share gains. Our Cobalt and Chrome high-power devices are also contributing, driving our CRTD product line to 74% growth in Q4. In TAVR, our share was up over a point year-over-year and was stable sequentially. We reached an all-time record of US TAVR implants in the quarter. Late last month, we announced interim results of our OPTIMIZE Pro study, which showed that our new implant technique is resulting in single-digit pacemaker rates. In addition, last week at EuroPCR, we announced very strong low-risk data, which showed that the advantages of our Evolute TAVR system are maintained over surgical valves at two years post-procedure. Importantly, our data showed no convergence of the TAVR and SAVR curves for death or disabling stroke, as well as continued low-valve thrombosis rates out to year two. This stands in contrast to our competition's Partner 3 data, And we'll leverage this data with implanting physicians as we continue to go on the offensive and win share in this important growth market. In our gastrointestinal business, we estimate that we gain share, both year over year and sequentially. Our GI diagnostic product lines grew in the low 50s, driven by a high 60s growth of our PillCam. Last month, we received FDA clearance for our GI Genius module, which uses artificial intelligence to assist physicians in detecting both precancerous and cancerous growths during colonoscopies. GI Genius can highlight lesions real-time and identify polyps that might otherwise go undetected by the human eye, improving the quality of colonoscopies. In our cranial and spinal technologies business, we estimate that we gain share in both spine and neurosurgery, both year-over-year and sequentially. Our strategy of bringing a digital ecosystem of enabling technology to spine procedures is working. We had record sales of our stealth station, navigation systems, OARM imaging systems, Midas Rex Capital, and advanced energy products. And we estimate that our Mazor robotic system continues to outpace our closest competitor. In ENT, we estimate that our share is up over a point year over year. The ongoing launches of our NymVital neuromonitoring system and StealthStation FlexiNT navigation system, coupled with ShareGain's indisposable sinus blades, are driving our above-market performance. In pelvic health, ShareGain continued with the momentum created by the launch of Interstim Micro and the SureScan leads. Our sales growth outpaced Axonit's in the calendar first quarter, and we did this despite having a far larger sales base. While the European sacral neuromodulation market remains sluggish due to COVID resurgence, the U.S. market continues to accelerate. Turning to neuromodulation, we estimate that we have gained about a point of paying stem share year over year and even more sequentially. Our SCS product line grew 73% in Q4, and we continued to outpace the competition in the calendar first quarter. The market continues to show strong enthusiasm for our DTM SCS therapy, which now carries a superiority label from the FDA. And our strategy of going after competitive account conversions is yielding great results. Our DTM trial adoption remained robust and grew sequentially, a good leading indicator for future growth in our pain stim business. In brain modulation, while we estimate we lost a couple of points of share year over year, we continue to gain sequential share on the back of the Percept PC launch. Percept has resulted in 10 points of new implant share gains in the U.S. since its launch last summer. So there are a number of businesses where we're gaining share, but there are still some businesses where we've got some work to do. In cardiac diagnostics, as we discussed last quarter, we continue to be supply-constrained with our new Link2 system in Q4, as we ramp our unique wafer-scale manufacturing. We estimate we lost about a point sequentially in mid-single-digit share points year-over-year, primarily to Boston Scientific. We're working through the supply ramp-up and expect to have improved supply in the back half of the fiscal year. In addition, we implemented a product ship hold on the Link 2 last week as we analyze an issue. In the meantime, customers are continuing to use our Reveal Link. Once we resolve the issue, we're confident that the proven market leadership of Reveal Link and the competitive differentiation of Link 2 will allow us to continue to win in this space. In our aortic business, we announced the voluntary recall of our Valiant Navion thoracic stent graft system in February. We also announced that we would be working to ramp production of our previous generation product, the Valiant Captivia, but that we would not be at full production until September. The loss of Navion had a $35 million impact to revenue in Q4 and resulted in us losing high teen share in the thoracic stent graft market. That said, our customers have expressed strong interest in using the Valiant Captivia product when inventory is available. And looking ahead, we're estimating that the quarterly revenue impact will decrease as we go through FY22, from $30 million in Q1 to $15 million in Q4. In neurovascular, we estimate we lost a couple of points of share year over year, driven primarily by new competitive flow diverters from Stryker and Terumo. That said, we saw our share stabilize sequentially as we launched our Solitaire X 3mm stent retriever in the U.S. and started the limited launch of our Pipeline Vantage flow diverter in certain CE-marked countries. We expect our new products to drive sequential share gains going forward. In diabetes, we continue to execute on our turnaround strategy, growing 9% this quarter. This is still below market, and we estimate we lost about five points of share year over year. However, our share was stable sequentially. Our new MiniMed 770G and 780G insulin pumps are giving us momentum, resulting in very strong double-digit global insulin pump growth. Next, let's turn to our pipeline. We're launching a number of products across the company, and even more are coming. We expect our robust pipeline to be the key driver of accelerating our top-line growth as we're at the front of some large opportunities to win share, create new markets, and disrupt existing markets. And as I noted earlier, we're continuing to fuel R&D investments such that our pipeline can be a continuous source of sustained revenue growth over the coming years. Starting with cardiovascular, one of our largest future drivers is renal denervation, as we develop our solution to go after the multi-billion dollar adjustable market in hypertension. We're expecting to present our on-med pivotal trial results later this year, likely at the TCT conference in November. And these results are likely to be one of the most highly anticipated events in MedTech this year. In cardiac rhythm management, we're planning to file for CE mark for our disruptive extravascular ICD technology this quarter. Let me repeat that. I said this quarter. And in our cardiac ablation solutions business, we're expecting a first-line therapy indication for our Arctic Front Cryo Balloon in the U.S. this coming quarter. We also continue to make good progress on bringing our disruptive pulse field ablation system to market with strong enrollment in our Pulsed AF Pivotal Trial. In structural heart, we received FDA approval in Q4 for our Harmony transcatheter pulmonary valve, the first of its kind and a breakthrough treatment for patients with congenital heart disease. In TAVR, we received low-risk Shonin approval in Japan and are expecting reimbursement approval later this fiscal year. We also expect the U.S. rollout of our next-generation TAVR valve, the Evolute FX, later this calendar year, which will feature enhanced deliverability and ease of use. Turning to our medical-surgical portfolio, another very important program is our HUGO robotic-assisted surgery platform. At the end of March, we reported that we'd submitted HUGO for CMARC and US IDE approval. Well, today, I'm happy to report that the FDA has granted the IDU approval, and we're preparing to commence our Expand Euro trial in the U.S. to study Hugo and urologic procedures. We also had our first revenue from Hugo placements at hospitals outside the U.S. in Q4. These systems will collect clinical data to support regulatory approvals in the U.S. and around the world. As you think about modeling the revenue from our surgical robotics business, we're expecting $50 to $100 million in FY22, and that's likely to roughly double or triple in FY23. We expect soft tissue robotics to be a meaningful growth driver going forward, not just for MedSurg, but for overall Medtronic. In our neuroscience portfolio, we have some exciting near-term milestones coming in our neuromodulation business. We're expecting to launch our Vanta recharge-free spinal cord stimulator in the first half of this fiscal year. This is a big opportunity for us to gain additional share in pain stim, given our low share in the recharge-free portion of the market. We're also on track to submit our eCAPS device to the FDA later this calendar year, which has the potential to be a disruptive technology in the spinal cord stim space. And in BrainMod, we're expecting FDA approval for our Sensight directional lead later this calendar year. This will close the key competitive gap and further differentiate our Percept PC system, which I mentioned earlier was already taking a lot of share in DBS. And in pelvic health, we received IDE approval last month to start our Titan 1 feasibility study. This trial will evaluate our implantable tibial system, a device that we think could substantially increase our ability to serve overactive bladder patients, many of whom do not seek therapy or remain on current therapy. In neurovascular, in addition to the Solitaire X3 millimeter stent retriever and pipeline vantage flow diverter that I mentioned earlier, we're rolling out five additional products this calendar year. This includes meaningful innovation for the stroke market, like our pipeline shield flow diverter in the U.S. and wrist radial access system. In diabetes, we recently received CE mark approval for our Zeus CGM sensor, which we'll be marketing as the Guardian 4 sensor. The no calibration data that was used to support the CE mark approval will be presented next week at the virtual ATTD conference, and the abstract is available on the ATTD website. We're pleased with the accuracy of Guardian 4 and that it has now been labeled for dosing without finger sticks. Starting this fall, Europeans will not only have access to the 780G with the highest reported time and range of any insulin pump, but also our Guardian 4 sensor with no finger sticks required and our extended infusion set with an industry-leading 7-day wear. We think this is a highly differentiated product offering and one that we can't wait to bring to other markets. In the U.S., the 780G and Guardian Force sensor are under active review with the FDA. Finally, we're making progress on our Synergy sensor, which is disposable, easier to apply, and half the size of our current sensor. We intend to submit the sensor to the FDA in the first half of the fiscal year, once we complete our manufacturing module. I'll now turn it over to Karen to discuss our financial performance and guidance. Karen?

Thank you, Jeff. Our fourth quarter organic revenue increased 32%. And adjusted EPS increased 159%. Significant growth as we anniversary the downturn we experienced at the start of the pandemic last year. Our end markets continue to recover from the impact of COVID, and we continue to execute on our strategy and launch new products, resulting in a sequential revenue increase of 5% and sequential adjusted EPS growth of 16%. Our adjusted EPS was 8 cents better than consensus, with 2 cents on higher operating profit and 6 cents from a lower-than-estimated tax rate. Our recovery from the COVID resurgence in December and January improved throughout the quarter, as expected. March was stronger than February, and April was stronger than March. We were particularly pleased with the strength of the last several weeks of the quarter, which we believe sets us up nicely for the start of our new fiscal year. From a geographic standpoint, we had strong 47% growth in the United States. Outside of the U.S., our developed markets grew 11%, with continued pockets of COVID resurgence in parts of Western Europe, Japan, and Canada. Our emerging markets grew 41%, driven by China growth in the low 90s. Our adjusted margins continued to improve sequentially, with 120 basis points on our gross margin and 190 basis points on our operating margin. Our adjusted nominal tax rate was 9.6%, better than initially estimated, given a favorable jurisdictional mix of profits along with certain one-time benefits. We've said throughout this past year that the actions we're taking during the pandemic to not only support our employees and our customers, but also continue investing, would impact our free cash flow. That said, we're pleased that we generated $4.9 billion of free cash flow, converting 81% of our non-GAAP earnings into cash, just above our long-term conversion target of 80%. During the quarter, we repaid in full a 300 billion yen term loan that was issued earlier in the fiscal year. And our year-end cash position remains above 10.5 billion. You can be assured that despite the pandemic, Medtronic continues to be in a strong financial position to drive our long-term strategies. Reflecting the confidence that we and our board have in the future growth of this company, this morning we announced that we are increasing our dividend by 9%. We are an S&P dividend aristocrat, having increased our dividend now for 44 years, and the dividend is an important part of the total return we generate for our shareholders. We also restarted our share or purchase program in the fourth quarter with a focus on covering dilution from our stock-based compensation. Now, turning to our guidance. We're confident in the continuing procedure recovery around the globe and the resilience of our end markets. And as a result, today reinstate giving formal guidance. We expect strong organic revenue growth acceleration in fiscal 22 to 9% plus or minus, a point above current street consensus. And while the impact of currency is fluid, if recent exchange rates hold, foreign currency would have a positive impact on full-year revenue of $400 to $500 million. By segment, we expect cardiovascular and neuroscience to grow 10 to 11 percent, medical surgical to grow 6 to 7 percent, and diabetes to grow 3 to 4 percent, all on an organic basis. You'll remember that last year we had an extra week in our fiscal calendar, and these growth rates have not been adjusted for that extra week, given the offset that we had from customer bulk purchases. As a result, we do not intend to adjust our organic growth in fiscal 22 for the extra week in fiscal 21. In the first quarter, we're comfortable with street consensus on revenue, which implies organic growth of 17 to 18 percent and a currency tailwind between $200 and $250 million at recent rates. By segment, we expect cardiovascular to grow 14 to 15 percent, medical surgical to grow 18 to 19 percent, neuroscience to grow 25 to 26 percent, and diabetes to be flat. With so many big opportunities in front of us, we're prioritizing R&D and commercial investments with growth above and beyond what you would see in a normal year. And we're allocating this capital across our businesses to our best opportunities. As you know, two of our largest opportunities are surgical robotics and renal denervation. We're purposely making significant investments in them to ensure we fully capitalize on the multi-billion dollar opportunities ahead. Just to give you a sense, when you combine the facts that it's early in the revenue cycle of these two programs with our heavy investment, We are planning for an operating loss of approximately $400 million next fiscal year from these combined programs. Yet, it is important to note that even with these kind of investments, we're still expecting operating margin expansion. This is the power of Medtronic's business model, that we can simultaneously make large-scale investments in some of the most important future technology areas in MedTech, cover the dilution and deliver strong profitability and returns for our shareholders on the bottom line we expect non-gap diluted eps in the range of 560 to 575 in fiscal 22 which includes a benefit of 10 to 15 cents from currency at recent rates for the first quarter We expect EPS of $1.31 to $1.34, above current street consensus of $1.29 to $1.31. And first quarter EPS would include a currency tailwind of about 3 cents at recent rates. Before I hand it back over to Jeff, I'd like to take a moment to recognize all of the employees across Medtronic. who scaled mountains this year, leaning in to deliver a great year under difficult circumstances. I'm proud to be part of such a terrific team, and I couldn't be more excited about the opportunities ahead of us. Back to you, Jeff.

Okay, thank you, Karen. Now, I'd like to close by emphasizing that there's a lot of energy here at Medtronic, and our momentum is building. You're seeing us perform better than our competition. We've executed in the short term, and we're investing for the long term. We've accomplished a lot in FY21, and this is a good start, but our expectations are higher. What will truly differentiate us is accelerating and delivering sustained revenue growth at or above our markets, not just over a year or two, but over the next decade. We have incredible programs in our development pipeline with robust expected financial returns. We're developing the next generation of medical devices that incorporate technologies like artificial intelligence, big data, and miniaturized electronics. These programs have the potential to truly change the future of medicine. When we look at the opportunities ahead of us and how we expect to translate these into strong returns for our shareholders, the future is bright. And finally, to our 90,000 employees around the world, thank you for everything that you've accomplished this past year. I'm sure they would agree with me when I say, if there's one thing you should take away from today's call, it's that Medtronic, we're just getting started. With that... Let's now move to Q&A. We'll try to get to as many analysts as possible, so we ask that you limit yourself to one question. If you have additional questions, you can reach out to Ryan and the investor relations team after the call. By the way, it's worth noting that the IR Magazine recently recognized our investor relations as the best of all companies in the United States, an award we're very proud to receive, as it was the result of voting from hundreds of investors and analysts. And we look forward to continuing to provide you with transparent communication and a high level of service. With that, Francesca, can you please give the instructions for asking a question?

For the self-sight analyst that would like to ask a question, please select the Participants button and click Raise Hand. If you're using the mobile app, press the More button and select Raise Hand. Your lines are currently on mute. When you are next in the queue, we will notify you directly via the Zoom platform chat function. You will then receive a request to unmute your line, which you must respond to before asking your question. Lastly, please be advised that this Q&A session is being recorded. For today's session, Jeff, Martha, and Karen Parkhill are joined by Sean Salmon, EVP and President of the Cardiovascular Portfolio and the Diabetes Operating Unit, Bob White, EVP and President of the Medical Surgical Portfolio, and Brett Wall, EVP and President of the Neuroscience Portfolio. We will pause for a minute to assemble the queue.

We'll take the first question from Bob Hopkins at the GiveAid Securities. Bob, please go ahead.

Oh, great. Thanks, and good morning. And just to make sure the technology is working okay, can you hear me this morning? Yes, we can hear you, Bob. Great. Thanks, Jeff. Appreciate the opportunity to ask a question and congrats on the momentum. I guess for my one question, given that it's such an important topic, Jeff, and you're such a major player around the globe, and I'm sure investors would love to hear a little more detail on just what you're seeing currently with the recovery and surgical procedures. And what you saw over the course of the quarter, you know, specifically, you know, are things continuing to improve here, you know, early in fiscal Q1? And are you now seeing year over year growth above pre-COVID revenue levels currently?

Yeah, thanks for the question, Bob. I mean, the way we look at this is by geography and then by product line or therapy. But I'll start with the answer. Overall, we're nearing a full recovery. And we're seeing with each month of the quarter, every month was better than the prior month. And that continued to improve and accelerate into May. largely driven by the U.S. market. I mean, once we hit that vaccination inflection point, I mean, I know a couple of months ago, people were worried that it wasn't moving fast enough. Then we hit an inflection point and things really opened up. And so in the U.S., we're, you know, depending what therapy you want to look at, anywhere from 85 to over 100 percent of pre-COVID levels. And like I said, every month got better. And then you got to look around the world. China is pretty much back to normal, totally. And, you know, Europe being our second biggest, Western Europe, if you look at that as one market, that is lagging behind the U.S. But look, we're confident. that when you have a health care system like they have with that kind of infrastructure, once they get the vaccinations going, it'll hit that same inflection point in the United States and open up. But as you know, they're a couple of months behind. The harder one to peg down is the emerging markets. I mean, places like India, where the virus is still raging, other parts of Southeast Asia, Latin America, You know, they don't have the same infrastructure, even when they get the vaccine. And there's a lot of people. So there's a lot of vaccines that you need to get there. So that's a harder one to pin down. But, you know, overall, as a company, like I said, we're nearing a full recovery, despite the emerging market piece really driven by the acceleration of the United States. And like I said, we expect Europe to come not too far behind. Any thoughts on Japan? You know, Japan, you know, it was doing pretty well, and then it slowed down a bit and is starting to come back. But like many of the developed market, it slowed down in that, you know, December, January timeframe, but it is starting to come back for us as well.

Thank you very much. Thanks, Bob. Let's go to the next question, please, Francesca.

We'll take the next question from Robbie Markets from JP Morgan. Robbie, please go ahead.

Oh, great. I'll add my congrats on the quarter. So, Karen, maybe for you, there's a lot to unpack here in the guide, and it's great to see revenues come in above the street, offset a little on EPS. I was hoping you could give a bit more color to what's assumed in there in terms of, you know, any bolus of recovery patients over the balance of the year. Anything you could give us on top and bottom line cadence throughout the recovery through the year and just, you know, how we think about operating margin versus some of the below the line items would be great. Thanks.

Thanks, Robbie. So in terms of revenue, clearly we're seeing a strong end to our fiscal year, and that's continuing into the first quarter, and we expect that momentum to continue. So from a revenue perspective, we expect increasing revenue growth on a two-year stacked basis throughout the year. In terms of, in terms of, you know, bolus of revenues, you know, we just expect it to be steady, steady increase. In terms of operating margin, we expect an operating margin expansion this year, even with our significant increase in investment, particularly against the robot and Ardian. And that's what's, you know, driving a guide in line with street expectations. Hopefully that's helpful.

Yeah, maybe just a quick follow up there on operating margin, because there's a lot of room in improvement. You know, is something like in the 28 to 28 and a half percent range the right place to be?

Yeah, I would say you can expect a few points, you know, roughly a little bit over three points of improvement in the year. And so we're, you know, we're driving that expansion at the same time that we're driving important investment.

Great. Thanks a lot.

Yeah.

Thanks, Robbie. Let's go to the next question, please, Francesca.

We'll take the next question from Vijay Kumar from Evercore ISI. Vijay, go ahead, please.

Thanks, guys, for taking my question. And, Jeff, congrats on a solid print here. I did have one question on surgical robotics. Actually, it's a two-parter. One, the 50 to 100 million expectation and perhaps doubling or tripling. What's, I guess, can you talk about the assumptions behind the wide range? Is that a timing related on perhaps when you might get the approvals in major markets? And related to that, I think you guys called out $400 million of operating losses, right, with revenue of 50 to 100. I think that implies perhaps a billion dollars of step up on the OPEC side. Where is that spend going and how should we think about profitability on these new initiatives? Thank you.

BJ, I might start by saying that the 400 million of operating losses that we shared with you is both the robot and RDN combined. It's not just the robot. And in terms of our assumptions behind the 50 to 100, you can expect it to accelerate into the year, particularly in the back half and the fourth quarter. And we're pleased to be launching this robot. And we're really excited about the prospects beyond this fiscal year into FY23, where we said that it should double or perhaps even triple.

Sorry, and that spend, perhaps, can you clarify how much of that is R&D versus the commercial organization?

Yeah, I'm going to let Bob White comment, too, but you can expect it's a lot. We're going to continue in R&D spending, and we're going to be building out Salesforce and customer service and support as well.

Yeah, that's right, Karen. That spend is really built as we now commercialize the robot. And as I've talked about in the past, Vijay, we've got a really exciting product pipeline across those four vectors of innovation, you know, instrumentation, data and analytics, visualization, and of course, the robotic system as well. Thanks, guys.

Thanks, Vijay. Next question, please, Francesca.

They will take the next question from Joanne Wench from Citi. Joanne, please go ahead.

Can you hear me okay?

Yes, we can, Joanne.

Wonderful. I'd like to spend just a couple of minutes on diabetes. There's two major medical meetings coming up, ATTD and ADA, and you're launching Guardian Sensor 4 and the Smart Insulin Pen outside the United States. So it's sort of a multi-part question, but first of all, what should we be expecting at these two meetings? As it relates to the sensor, could you give us some of the parameters? I know zero calibrations, but I'm curious on MARD. And then lastly, how do you look to price these products as you bring them first outside the United States and then into the United States? Thanks.

Okay, Joanne, maybe I'll have Sean answer those questions.

Okay, thanks, John. Yes, we've got a lot coming out next week at ATTD. You pointed to the sensor data, which will be released. There's the abstract available on the website right now, which includes the MARC numbers. We also have information coming out in the 780G experience, which I'd point you to look at. The first 4,000 patients in real-world experience are being launched there. We'll have additional SmartPen data coming out at the ADA meeting. But in terms of your specific question on MARG, that's really not a great metric to look at. There's sort of an overall average of how the difference is looking across the full range of the sensor. But what you really want to know is when your blood sugar is high or when it's low, is your sensor accurate? And those data are really accurate, and you'll see that in the presentation. And the other thing that's important is the trending. Is the blood sugar reliably going up or down? And that's really what matters. Kind of like A1C is a big average over time for glycemic control, and time and range replace that metric. Really, the accuracy at the right places in the range is what's important, and you'll see that in the data that's being presented. In terms of pricing, there's no plan to change the pricing between what we've done with Guardian Sensor 3 or Guardian Sensor 4 in any market.

Thank you.

Thanks, Joanne. Next question, please, Francesca.

We'll take the next question from Chris Pasquale at Guggenheim Security. Chris, please go ahead. Thanks.

Can you hear me okay? Yeah, we can hear you just fine, Chris.

Great. I wanted to follow up on the diabetes business. You know, 3 to 4 percent growth coming off of a year in which sales were flat doesn't imply a ton of progress on the turnaround at FY22. I'm curious whether that guidance really assumes any contribution from 780G and Zeus in the United States, and maybe tied into that, just your latest expectations on the timing of potential FDA approvals for those products?

Yes, Chris, I'll take the first part. I'm going to let Sean comment on the second part. But one thing to keep in mind with our diabetes guide is that we purposely did not adjust for the extra week across the whole company that we had last year because the reduction in bulk purchases offset it. But that reduction in bulk purchases did not affect our diabetes business. So really we need to look at it with the loss of the extra week that is indeed affecting them. And that loss of the extra week is about 150 basis points on the year. So hopefully that's helpful.

Yeah, just to build on what Karen said, we also had a bit of a comparable issue within some international markets where there was some stockpiling of the consumables that get used. So that's a little bit of a year-on-year comparison. But the bigger effect for us is that the installed base in the last six months, those coming out of warranty in the last six months, was just higher than what we're going to see in the first half of the fiscal year. So just getting a difference in how many patients come out of it with timing. And certainly the new product flows you mentioned, 780 and Zeus for the U.S. will be the most important for us to continue to move both patients from the installed base as well as those new patients, those coming out of MDI or competitors. I don't have an update on the timing. We're in active review, as Jeff said, on the filing. And the reviewer that's working with us is the same one that reviewed the 770 device. So we think that that familiarity is going to be helpful. But there's no update on timing at this point.

Thanks. Yeah, just, you know, it's good to see, though, the pipeline starting to, you know, show up here. I mean, we're looking forward to get to the U.S., but 780G, the new sensor, the extended wear infusion set, it's a pretty powerful combination. And we're seeing great clinical results and great patient feedback. And I think you'll see that in the data that comes out. And it's a good leading indicator of what we're going to see in the United States when it gets here.

Thanks, Chris. Let's go to the next question, please, Francesca.

We'll take the next question from Larry Beagleson from Wells Fargo Securities. Larry, please go ahead.

Good morning. Thanks for taking the question. Just one for Sean on renal denervation. So, Sean, you know, for the on-med data at TCT, is the pilot data a good proxy? You know, I think with the off-med, we saw little degradation in the efficacy. You know, would you expect the same here? And can you have reimbursement? You know, how should we think about the RAM, you know, given the uncertainty around reimbursement? I think we all understand it's a big opportunity. You guys are really excited about it. But how do we think about, you know, is it something that could be a slow ramp because reimbursement may not be in place upon approval? Thanks for taking the question.

Yeah, thanks, Larry. I think there is a good proxy for that pilot study. It sort of informed our decision, should we continue on in this work studying? So we think, you know, that magnitude of benefit could be there. But you're right to point out that when you get into, you know, more centers, more patient and physician variables, things can move around a little bit. So we'll see what that looks like. But we're confident that the trial is designed properly to get us the right answer. The reimbursement is certainly the hurdle. We do have CE mark. We have approval in a lot of countries, but getting that paid for is going to be important. And in the United States, we're awaiting legally the proposed rule on IMSSET to allow four years of coverage as we develop further evidence upon approval. Now, that doesn't cover payment. We still have work to do there. We still have to go payer by payer because a lot of the patients will fall into the non-Medicare category. bucket of patients. But we've been working that for a number of years, frankly, to make sure that we have the right evidence to satisfy their needs, which really, frankly, drove the need for an on-med trial to begin with. But yeah, we've got a lot of work ahead of us, but we're very excited about the opportunity, and it's getting closer and closer. Thanks, Sean.

Thanks, Larry. Next question, please, Francesca.

We'll take the next question from Rick Weiss from Stiefel. Rick, please go ahead.

Good morning, everybody. I guess I have a question that maybe is for both Jeff and Karen. It's about cash and maybe talk about your cash generation potential in the year ahead and your thoughts about some of the key drivers there. But maybe, Jeff, you could expand on your thoughts about the use of cash in the sense that, I mean, you all indicated that you're buying back stock to offset dilution. You've raised the dividend. So that sort of leaves M&A Is the year ahead going to be a year of more intense M&A activity? You have so much going on internally. Is this a priority and maybe any color about how you're thinking about your priorities as you look ahead? Thank you.

Sure. Thanks. Thanks for the question, Rick. You know, in terms of like our priorities, our priorities are investing in growth. And today we announced the largest increase in R&D in our history. And it's because we're seeing these large market opportunities with clear patient need where Medtronic has a right to win. And so we're looking at those holistically, investing organically in R&D, but also other growth investments. Like we talked about ahead of certain product launches like Guardian and the robot. So we're investing in sales and marketing. and other related growth investments. But inorganics is still a priority. We did a number of deals last year, tuck-in deals, and I'd say tuck-ins are still the focus. And those tuck-in deals could be up to several billion dollars. I mean, the ones we did over the last 18 months have been smaller than that. But, you know, I wouldn't mistake size for impact. Some of these ones like MediCreate, which is the AI planning tool and outcomes tracking tool for spine is a real nice piece of the puzzle for our spine strategy. And a couple of questions here on the call today about our smart pen, the companion medical. So these are impactful deals and we look to continue those. And so it's still a priority and over and above over buybacks. And we'll see how the year plays out. It's tough to predict, right? We're going to remain disciplined here. But I think the theme I'd walk away with is that we're committed to investing in growth, both organically, inorganically, and doing what it takes to do that. and still deliver on the EPS growth expectations that we set out. And so that's what the team's focused on, and you're seeing the benefits of that. Oh, Karen, if you want to.

Yeah, I would just add, Rick, your first question on cash generation in the years ahead. Clearly, we are focused on driving strong conversion of our non-GAAP EPS into cash. And, you know, we've said we've targeted greater than 80% conversion rate. That doesn't change. So we remain focused on delivering that. And we also, you know, are growing cash along with our earnings. And we're focused on driving continued working capital productivity. And our day sales outstanding, our day's payable, our inventory. So you can expect us to continue to have this keen focus on cash flow and driving strong results from it.

Thank you very much. Thanks, Rick. Next question, please, Francesca.

We'll take the next question from Matt Mixick from Credit Suite. Matt, please go ahead.

Matt, you there?

Hi, can you hear me okay?

Yeah, now we can. How are you doing, Matt?

I'm well, thanks. Thanks so much for taking the question. So one on your robotic surgery programs, if I could. The first part, if you could maybe just talk a little bit about how some of the pandemic conditions around the world are affecting your progress so far, how you're thinking about fiscal 22 and some of the range that you put out there in that $50 to $100 million. And then Secondly, you know, there has been this, what feels like a bit of an inflection point in terms of robotic surgery momentum and placement throughout the back end of last year and the first part of this year. I'm just wondering how, if you could describe your, you know, how you compare the fourth quarter to the third quarter and how the cadence feels in terms of new placements and pull through in your current program as well.

Okay, yeah, I was going to ask you to clarify because when you said robotics, I wasn't sure. So on the spine side, look, Matt, I know you followed this for years. The strategy of surrounding the spine procedure and preceding the spine procedure and following up the spine procedure with enabling technology from surgical planning to to navigation, interoperative imaging, the robot, this is paying off. I mean, we had record sales last quarter of our capital equipment tied to spine procedures and continue to outpace the competition on the robotic sales. But more than anything, okay, more important than all of that is the surge in feedback that we are getting has hit an inflection point. They are now talking about the outcomes that they're getting from this. It's the planning, the precision of the planning to get the right alignment plan in there. And then the accuracy of executing to that plan with NAV and the robot, and then the ability to follow it up and access images in the PAC system through MetaCrea to come back and retrain or continue to evolve our algorithms. And also show surgeons, are you really getting that alignment? uh, that you, you thought this is, uh, is, is, is coming together. And we, I think we're separating ourselves, uh, from the pack and really, you know, really getting closer to what our ultimate goal here is, is to transform spine surgery from the art that it is today to a science and then demonstrate it with outcomes. So that is something we're very excited. Like you mentioned the, the momentum, the momentum, the, the lagging in, you know, the momentum from the enabling technology, like I said, record sales, uh, And it's because the buzz is out there, you know, from surgeons starting to talk about the results they're getting from using this. And people that were sitting on the sidelines are jumping in, and the bus is moving. The trains left the station on this one. And the feedback from our field, again, a lagging indicator, is palpable, the energy. So we're feeling really good about spine and robotics. And then the lessons that we've learned, From Spine, we are spending a lot of time, our Spine team and Brett Wall working with Bob White and Megan Rosengarten on the soft tissue robot. I think a lot of those lessons learned. I mean, the markets aren't the same. They're different, but there are some lessons learned and there are some synergies there that we will incorporate into our Hugo soft tissue robot launch.

Thanks so much.

Thanks, Matt. Next question, please, Francesca.

We'll take the next question from Jason Bedford from Raymond James. Jason, please go ahead.

Good morning. I just wanted to get back, Karen, to the operating margin commentary. It looks like you did just under 24% in fiscal 21. I think you mentioned you're expecting a little over 300 bps in fiscal 22. So is the anticipation that out margin in 22 is going to be around 27%?

Yeah, yes. So 27, 27.5, you know, in that range for the year. But keep in mind that our op margin should improve as we go through the year. And so by the end of the year, we expect it to be, you know, above that 28%. Okay.

Just any commentary on gross margin?

Yeah, gross margin, we also expect sequential improvement, about half a point of sequential improvement in the gross margin through the year.

Thank you. Thanks, Jason. Next question, please, Francesca.

We'll take the next question from Danielle Antalfi from SVB Lyrinc. Danielle, please go ahead.

Hey, good morning, everyone. Thanks so much for taking the question. Jeff, I just wanted to follow up on a comment you made earlier regarding it depends on the business line as to the recovery. Where are the business lines that are lagging and sort of when are you expecting those business lines to get back to full recovery relative to some that have already gotten there? Thanks so much.

Well, in the... Yeah, I'd say in the United States, even the ones that are lagging, I would expect them to get back to a full recovery in our fiscal Q1. And the ones that are lagging are more, you know, the more elective areas like E&T. our GI business, our endovenous business. And it is, all those businesses that I mentioned, we talked in the commentary about ENT and GI gaining share. So it's not a competitive thing. It really is a COVID issue. And in the United States, we expect those to get back in our fiscal Q1. And then, you know, we talked about before Europe's lagging by a few months and emerging markets hard to predict. But it comes down to the elective nature. You know, there's a spectrum, you know, maybe stroke. And on one end, not very elective, at least from my perspective. And on the other end, you have some of these ones I just mentioned, like ENT, GI, endovenous. I don't know if that answered your question, Danielle. No.

Thanks, Danielle. We'll take one more question, please, Francesca.

Okay, we'll take the last question from Steve Lickman from Oppenheimer. Steve, please go ahead.

Thank you. Good morning. Jeff, I was wondering if you could talk about the benefits you're seeing from the more decentralized operating structure now a year in. Is it delivering what you had hoped? Any comments on the changes you're seeing on the ground would be helpful. And just to clarify, FY22 will be the first year that market share will be included in compensation? Thanks.

Yeah, the answer to your last question is yes, FY22 will be the first year. We need to work on how to measure this over the course of FY21 precisely enough to put it in comm. So in terms of the operating model, I'd say, look, the dust is still settling a bit, but we are definitely past, I'd say, the most difficult part, and I'm excited about where we're headed. You know, we've got increased role clarity and accountability across the org and this new decentralized model. And people are now looking forward and focused on their key metrics. So, like, for our operating units, it's this innovation pipeline. It's their market growth. It's their market share, as we just talked about. And this market share one is liberating for us because, you know, instead of comparing ourselves to ourselves, we're comparing ourselves to the market with a clear expectation to grow at or above the market. That clarifies a lot. You know, for our regions, things like strategic account growth over and above, you know, what we're getting, you know, in the traditional MedTech model of selling to the specialist position and focused on those patients. But in addition to that, the strategic account growth, you know, for our executive committee, right, for the people on this call, you know, measurements around capital allocation to the high growth segments. portfolio management, all in a focus to increase our overall company weighted average market growth rate. And then finally, I'd say there's lots of excitement, more than I would have thought maybe even about the culture changes, this thing we're calling the Medtronic mindset that has these, it really works alongside our mission. Medtronic's known for a mission-driven company. We always want to be known for that. That's kind of our why, if you will. But adding these things like acting boldly, competing to win, You'll move with speeding decisiveness, delivering results the right way. Adding these in to the mix alongside our mission has generated a lot of energy, and it's kind of taken off organically inside the company. And so, you know, I'd say overall, you know, really happy with where it's going, and we're starting to see the results of this.

Okay. Thanks, Steve. Jeff, please go ahead with your closing remarks.

Sure. All right. Well, thanks, everybody, for the questions. And, you know, we really appreciate your support and your continued interest in Medtronic. And we hope you'll join us for our Q1 earnings for our webcast, which we anticipate holding on August 24th, where we'll update you on our progress. And so with that, again, thanks for tuning in today. And please stay healthy and safe and have a great rest of your day.