美敦力 (MDT) 2022 Q1 法說會逐字稿

Good morning, and welcome to Medtronic's Fiscal Year 2022 First Quarter Earnings Video Webcast. I'm Ryan Weispfenning, 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 are Geoff Martha, Medtronic Chairman and Chief Executive Officer; and Karen Parkhill, Medtronic Chief Financial Officer. Geoff and Karen will provide comments on the results of our first quarter, which ended on July 30, 2021, and our outlook for the remainder of our fiscal year. After our prepared remarks, our portfolio executive VPs will join us, and we'll take questions from the sell-side analysts that cover the company. 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 in our earnings press release or on our website at investorrelations.medtronic.com.

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. First quarter organic revenue comparisons adjust only for foreign currency as there were no acquisitions or divestitures made in the last 4 quarters that had a significant impact on total company or individual segment quarterly revenue growth. References to sequential revenue changes compare to the fourth quarter of fiscal '21 and are made on an as-reported basis and all references to share gains or losses refer to revenue share in the second calendar quarter of 2021, unless otherwise stated.

Reconciliations of all non-GAAP financial measures can be found in 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.

With that, let's head into the studio and get started.

Hello, everyone, and thank you for joining us today. We started off fiscal 2022 with a strong first quarter, beating Street estimates on revenue, margins and EPS. We drove market share gains across a number of our businesses, including 3 of our largest: Cardiac Rhythm, Surgical Innovations and Spine. Our results reflected the recovery of elective procedures during the quarter, with most of our businesses finishing at or above pre-COVID levels.

Now while the Delta variant is having an impact on procedure volumes in certain geographies, we believe the effects will be manageable. Health care systems are really just better prepared and vaccination rates continue to increase.

Our new operating model and the Medtronic mindset culture enhancements are delivering results, as our first quarter performance demonstrates. Our employees are energized by the transformation of our organizational structure and the competitive culture. And our most recent employee engagement survey results were the strongest that we've ever had.

We continue to focus on accelerating and sustaining higher top and bottom line growth at Medtronic. In fact, we've already made a number of disciplined and targeted capital allocation decisions that drive that acceleration. We've increased our investments at the front end of major product launches in surgical robots and renal denervation, which represent large new markets for Medtronic. We're growing our R&D investments broadly across the company, complementing a long list of organic opportunities with disciplined tuck-in acquisitions, such as our recently announced intent to acquire Intersect ENT. Now we expect these actions to drive share gains in our markets today, which we've talked a lot about and to increase our weighted average market growth rate, producing stronger returns for our shareholders.

Now turning to the details of our first quarter results. We'll start again with a brief look at our market share performance. It's an important metric that our teams are being evaluated against, along with revenue growth, profit and free cash flow.

We continue to see a number of our businesses winning share, driven by our innovation and increased competitiveness. And it's worth noting that when we talk about our share dynamics, we're referring to revenue share in calendar quarter Q2.

We gained share in our 3 largest businesses this quarter. Our Cardiac Rhythm Management business continued to perform well above the market, adding over 3 points of share, driven by our differentiated Micra family of pacemakers, Cobalt and Crome high-power devices and our TYRX antibacterial envelopes.

In Surgical Innovations, we gained share as our endostapling and Advanced Energy technology continues to be the preferred and trusted instruments used by surgeons all around the world.

And in Spine, the ecosystem that we offer of spine implants, biologics and enabling technologies like the preoperative planning software, robotics, imaging and navigation, resulted in above-market growth for Medtronic.

And it's not just our largest businesses that are winning share. We also had share gains in some of our faster-growing businesses, like TAVR, Pelvic Health and Pain Stim as new evidence, technology and sales execution resulted in Medtronic outpacing our competition. In Pain Stim, we did observe gradual slowdown in permanent implants and trialing procedures in the latter parts of our quarter due to the Delta variant. And we do expect that this will affect the market during Q2.

That said, we continue to win share and have a lot of momentum in our Intellis with DTM technology. And with the launch of the Vanta recharge-free system, our portfolio is complete, highly competitive and well positioned.

Now while we're winning share in a number of our businesses, we still have areas where we have work to do. In Cardiovascular, we continue to lose share in our cardiac diagnostics business. However, we do expect these trends will reverse over the course of our fiscal year as we ramp up supply of our LINQ II insertable cardiac monitoring system.

Now we also lost share year-over-year in Neurovascular, but we were pleased with our momentum as we ramped our recent product launches. This included our 2 new flow diverters, the Pipeline Flex with Shield technology in the U.S. and the Pipeline Vantage in Europe as well as our Solitaire X 3-millimeter stent retriever.

And finally, in Diabetes, we continue to execute our turnaround strategy. But as expected, we continue to lose share in the U.S. as we wait for new product approvals. We understand the current challenges we face in Diabetes, and we believe our product pipeline and our differentiated technologies will return us to market growth as these products move through development, approval and ultimately become available to patients.

Now speaking of new products, let's now turn to our product pipeline. Today, you're seeing the strong flow of new products launching across our businesses. We've launched over 190 products in the U.S., Western Europe, Japan and China in just the last 12 months. We also continue to advance the innovation we have in development. We're increasing our R&D spend by more than 10% this fiscal year. This is the biggest dollar increase in R&D spend in our company's history. The investments we're making in our pipeline will play a key role in accelerating our top line growth, and we're at the front end of some large opportunities to win share, create new markets and disrupt existing markets.

Starting with one of our largest future growth drivers, renal denervation. We're making good progress on our solution to go after this multibillion-dollar hypertension opportunity. We expect that the results of our ON MED pivotal trial will be ready for a presentation at the TCT conference in November, assuming the interim look at this Bayesian design study reaches statistical significance. The ON MED clinical trial represents the final piece of a large body of evidence that we intend to submit to the FDA for approval.

The progress on our Surgical Robotics business has been impressive in recent months, and we have momentum on a number of important milestones and initiatives. But most notable, and something that has energized our entire company and the robotics team, the first procedures with Hugo were performed at Clínica Santa Maria in Chile by Dr. Ruben Olivares in June. And as is said, a picture is worth a thousand words. So let's watch this short clip detailing this important milestone.

(presentation)

It's truly amazing to see our robotic technology in use, and I want to thank the hundreds of Medtronic employees that have worked tirelessly over many years as well as the surgeon and hospital leaders whose partnership help make Hugo a reality. We look forward to expanding the surgical robotics market by addressing the per procedure cost and utilization barriers that have limited robotic surgery to date.

And shortly after the first urological procedures in Chile, we had the first gynecological procedures performed last month at the Pacifica Salud Hospital in Panama. We're receiving positive feedback from our early users for our approach to robotic surgery, including our thoughtful design choices. For example, as you can see by this picture, our open console design allows for natural interaction and participation of the entire surgical team. And it's just one of the many important differentiated features of Hugo.

Looking ahead, we remain on track for CE Mark approval of Hugo following our submission in late March. And we continue to make progress towards starting our U.S. EXPAND Euro pivotal trial where the first procedures in the U.S. will occur.

Around the globe, a number of hospital systems have expressed interest in our Partners in Possibility Program, joining a group of pioneering hospitals that will be among the first to use Hugo.

In Cardiac Rhythm, we filed for CE Mark for our Extravascular ICD this quarter, and enrollment is going well in our U.S. pivotal trial. EV ICD represents a disruptive technology in implantable defibrillator space as it can pace and shock without leads inside the heart. And they can do all of this in a single device with the same size and longevity of a traditional ICD.

In TAVR, we continue to advance our Evolut platform, and I am pleased to share with you the news today that we just received FDA approval last week for our next-generation Evolut FX TAVR system. Now this innovative system is designed to improve the overall procedural experience through enhancements in deliverability, implant visibility and deployment stability. We're planning to start rolling out this next-gen system in the U.S. market later this fall.

In Neuromodulation, in addition to receiving FDA approval in the quarter for our Vanta recharge-free spinal cord stimulator, we also received FDA approval for our SenSight Directional Deep Brain Stimulation Lead. Now SenSight, combined with our recently approved Percept PC system, is the only DBS system on the market that can sense and record brain activity in addition to providing normal stimulation to treat diseases like Parkinson's and essential tremor. We also remain on track to submit our ECAP spinal cord stimulator to the FDA later this calendar year, which has the potential to be a disruptive technology in Pain Stim.

Now moving to our Pelvic Health business. As you know, we don't reveal all of our development programs underway at Medtronic for competitive reasons, but I'm going to unveil a new one today. We've been working in stealth mode on our next-gen InterStim recharge-free device. And earlier this month, we submitted our PMA supplement to the U.S. FDA, seeking approval. Now this device has some very attractive specs. It's designed with a 10-year battery. It's got constant current. And it's full body MRI compatible at both 1.5 and 3 Tesla. We're expecting approval in the first half of next calendar year, and we can't wait to have this best-in-class recharge-free device available for patients.

In Diabetes, the international launch of our MiniMed 780G insulin pump continues to go well. The 780G has the highest reported time in range of any insulin pump. And starting this fall, people with diabetes in many international markets will not only have access to the 780G, but also our no-calibration 7-day Guardian 4 sensor and our 7-day extended infusion set, the longest-lasting set on the market. This complete offering will be highly differentiated and ease patient burden, and we're working to bring this technology to other markets.

In the U.S., the 780G and Guardian 4 sensor continue to be under active review with the FDA. And we're expecting to submit our next-gen Synergy CGM sensor to the FDA in Q3. Synergy is disposable, easier to apply and half the size of our current sensor.

I'll now turn it over to Karen to discuss our financial performance and our guidance. Karen?

Thank you, Geoff. Our first quarter organic revenue increased 19% and adjusted EPS increased 127%, significant growth as we anniversary the downturn from the pandemic impact last year. Our end markets are recovering, and we continue to launch new technology and gain market share, which is reflected in our growth and profitability. Our adjusted EPS was $0.09 better than consensus, with the entire beat coming from higher revenue growth and operating profit.

As I noted on our last earnings call, we did not adjust our first quarter results for the extra week of sales last year given the concurrent reduction of customer bulk purchases, as these 2 items roughly offset each other at the total company level. That said, not all areas of the company had large quarter end customer bulk purchase activity, Diabetes, for example. As a result, I would point out that our Diabetes growth rate would be roughly 6 points higher in the first quarter had we adjusted for the extra week.

On our cadence of recovery, the monthly improvement trends continued. Average daily sales in June were stronger than May, and July was stronger than June. That said, we did begin to see a slowdown in certain businesses in the last few weeks of July related to the spread of the Delta variant in the United States. If not for the COVID impact in July, our first quarter performance would have been even stronger.

Turning to our P&L. We saw significant year-over-year improvement in our margins, 670 basis points on gross margin and over 1,000 basis points on operating margin. Our operating margin was better than expected as investments we initiated in the first quarter took longer to ramp but are expected to pick up starting in the second quarter.

Turning to capital allocation. We continue to balance our investment for future growth while returning cash to our shareholders, primarily through our strong and growing dividend. As we've noted for several quarters, we are increasing our level of tuck-in acquisitions, having announced 7 for a total of $2.3 billion since the start of fiscal '21.

Less than 3 weeks ago, we announced our intent to acquire Intersect ENT. Our ENT business has quietly been a strong performer for us, led by a great team with a track record of consistently outperforming the market. With the addition of Intersect's complementary products, we can accelerate the growth profile of this business for years to come. The deal is accretive to our weighted average market growth rate; initially neutral, but quickly accretive to earnings and has expected returns well ahead of our cost of capital.

Now turning to our guidance. As you know, it is still early in our fiscal year. We had a strong first quarter. And despite the current impact from COVID, we are optimistic about the outlook for the year. Given how early it is in the year, we are maintaining our revenue guidance for the full year at 9%, plus or minus. If recent exchange rates hold, foreign currency would have a positive impact on full year revenue of $100 million to $200 million, down from the prior $400 million to $500 million I gave last quarter.

By segment, we continue to expect Cardiovascular and Neuroscience to grow 10% to 11%, Medical Surgical to now grow 8% to 9% and Diabetes to be roughly flat, all on an organic basis. On the bottom line, we are raising the lower end of our guidance by our first quarter beat, offset by a lower expected benefit from FX. We now expect non-GAAP diluted EPS in the range of $5.65 to $5.75, an increase from our prior range of $5.60 to $5.75. This includes a currency benefit of $0.05 to $0.10 at recent rates, down from the $0.10 to $0.15 benefit we signaled last quarter.

Our second quarter is likely to reflect the current impacts from COVID, particularly in a handful of businesses in Cardiovascular and Neuroscience. So we expect organic growth in the quarter of around 4%, with a currency tailwind of $0 to $50 million at recent rates. Keep in mind that we are facing a particularly tough comp in our ventilator business, which peaked in the second quarter last year. Ex ventilator sales, we expect organic growth in the quarter around 6%.

By segment, we expect Cardiovascular to grow 5% to 6%; Neuroscience, 6% to 7%; and both Medical Surgical and Diabetes to be flat to up 1%, all on an organic basis. Excluding ventilator sales, Medical Surgical is expected to grow 8% to 9%.

We expect EPS between $1.28 and $1.30, with a current tailwind of about $0.04 at recent rates.

As previously mentioned, we do believe the near-term COVID impact to our business will be relatively less severe than prior waves, given hospital preparedness and increasing vaccination rates around the globe. That said, to be conservative, our guidance does not assume that procedures canceled in the near term will be rescheduled. So to the extent those procedures are simply delayed, that should be upside.

We are confident as ever in the strength of our underlying business, our execution and the impact of our new products. We saw that in the first quarter. And as we move past the current impact of COVID, we feel really good about the underlying strength for the rest of the year.

Before I send it back to Geoff, I'd like to step back and acknowledge how much our employees have accomplished over the last year since the pandemic started. And our results this past quarter reflect that unwavering focus by our global team to drive our business and fulfill our mission. And for that, I'm incredibly proud.

Back to you, Geoff.

Okay. Thanks, Karen. Next, I'd like to cover a few ESG-related topics: inclusion, diversity and equity as well as product quality.

First, inclusion, diversity and equity, something that is personally important to me and important to our success at Medtronic. Now we best fulfill our mission when we have a workplace where ID&E for all of our employees is championed. While we know there is much more to be done, we've made a lot of progress here, and this is being recognized by others.

I mentioned our DiversityInc award last quarter, and we were recently recognized by several other organizations for our innovative and inclusive work environment. We were named as one of Fast Company's Best Workplaces for Innovators in 2021, as a Best Place to Work for Disability Inclusion by the Disability Equality Index, and we were one of the 15 companies awarded the Secretary of Defense Freedom Award for our efforts to support our military veteran employees.

Next, I want to emphasize our continued focus on product quality. Striving without reserve for the greatest possible reliability and quality in our products is a key tenet of the Medtronic mission and core to our commitment to improved outcomes for patients. In fact, there is nothing more important than patient safety.

In Q1, we made the decision to stop HVAD sales. We did this because of a growing body of clinical comparisons indicating that our device had a higher frequency of adverse events than a competitor's product. This decision was consistent with our commitment to patient safety. Importantly, we remain committed to supporting current HVAD patients, their caregivers and health care professionals.

At Medtronic, we have a purpose deeply rooted in our mission, and our employees translate this mission into tangible day-to-day actions, which in turn create an impact in our society.

When I reflect on product quality and ID&E, we've made progress but there's always room for improvement. One step is ensuring that we have the right incentives in place to drive the actions that will elevate our impact. Our Board and executive leadership have been evaluating our annual incentive plans. And as a result of this, we're planning to further strengthen our existing quality metrics and we intend to introduce new ID&E metrics into our incentive plans. These will help guide our plans and drive our work on a daily basis and ultimately hold us accountable to translate our actions into even greater impact.

For those of you that would like to learn more about our ESG efforts underway at Medtronic, I encourage you to save the date to virtually attend our first ever ESG investor and analyst event, which we're planning to broadcast on Wednesday, October 13. You're going to hear from leaders from across Medtronic covering important topics, including inclusion, diversity and equity and product quality and safety.

And I'll close by noting that we are on track to accelerate our revenue growth. We're executing on our pipeline, and we're winning share in the marketplace with our leading technology. And we have some really big opportunities ahead of us, with near-term milestones in both renal denervation and Surgical Robotics businesses. And the energy across the organization is palpable as we operate under a new model and instill our new cultural traits, including acting boldly, competing to win, moving with speed and decisiveness in everything that we do and getting results and getting them the right way.

And to our employees, many of whom I'm sure are watching today, thank you. I truly appreciate your efforts to deliver these results. Look, these are exciting times, and I'm really looking forward to all that we're going to accomplish over the coming months. Momentum is building, and we're creating value, and there is a lot more to come.

With that, now let's move to Q&A. Now we're going to try to get to as many analysts as possible. (Operator Instructions) If you have additional questions, you can reach out to Ryan and the Investor Relations team after the call. With that, Francesca, can you please give the instructions for asking a question?

(Operator Instructions) Lastly, please be advised that this Q&A session is being recorded.

For today's session, Geoff 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 from BofA Global Research.

Okay. Just a technology check here, can you hear me okay?

Yes, sure. We can hear you just fine, Bob.

Excellent. Thanks, Geoff, and congrats on a good start to your fiscal year. I guess since we're limited to one question, I'll ask something a little bit more short term-oriented. And that is that you guys mentioned that at the end of July, you started to see a little bit of a slowdown. I'm just curious, has that slowdown stabilized at this point? Or are things still getting worse? And if you could kind of give us a sense for what you're seeing geographically, especially in China, that would be appreciated, too. So I just want to get a sense for whether things have stabilized relative to what you saw start to happen at the end of July.

Bob, it's Karen. Thanks for the question. So the slowdown that we started to see the last couple of weeks in July has continued into August. And we do expect the Delta variant to impact us, particularly in the United States this quarter, and particularly in certain of our businesses in Cardiovascular and Neuroscience. Really, those businesses that are impacted by deferrable procedures, like in cardiac diagnostics, ICDs, Pain Stim, Spine, and also in those businesses that require ICU bed capacity for the procedure like in TAVR.

That said, we expect this Delta variant to -- infection rates to peak probably in late August to early September and the hospital and ICU capacity to improve a few weeks after that. And so by the time we exit our second quarter, we expect procedures to be back to more normal. But we've reflected all of this in our guidance for the second quarter. And we're really bullish about the underlying strength of our business, not just in the second quarter, but in the back half and the full year ahead.

And then on China?

You asked about China. Yes, I mean, look, Bob, we're seeing limited impact so far in China, much less so than the prior waves. I mean they're pretty aggressive, if you will. When they see a COVID case, they kind of isolate that geographic area and they do reduce mobility, but they have kept consumer mobility, if you will. But they've kept the hospitals open, and I think they handled it pretty well. So we've seen limited impact so far in China.

We'll take the next question from Robbie Marcus from JPMorgan.

Congrats on a good quarter. Maybe just to follow up on the last question a little bit here. Karen, I know you don't give quarterly guidance, but I just want to make sure The Street's appropriately factoring your comments. We're a little shy of $8.2 billion in sales for consensus and $1.35 for fiscal 2Q. Maybe just help us gauge if that's an appropriate place to be given your comments on the COVID impact. And any other cadence through the rest of the year you'll be willing to point us to?

Yes. Thanks, Robbie. So for the second quarter, with the impact of the Delta variant, we're expecting growth around 4%, as we mentioned. That includes what we estimate to be about 150 basis point impact from COVID. So stronger underlying growth outside of COVID.

And I would also remind you that we've got ventilators coming down off of our peak in the second quarter last year. That's another about 200 basis point headwind.

And then with our decision to no longer sell and distribute LVADs in our MCS business, that's another about 50 basis points headwind. So the true underlying strength when you take out COVID, the impact of events and MCS is around 8% for the quarter.

In terms of EPS, we're guiding for the quarter $1.28 to $1.30. That includes a currency tailwind of about $0.04. And if we think about the rest of the year, we'll give Q3 guidance on our Q2 earnings call. But I would keep in mind that you can expect our investment to step up over the next coming quarters, really as we progress toward these important new product launches. Hopefully, that's helpful.

We'll take the next question from Matt Taylor from UBS Equities.

Good start to the year. Can you hear me okay?

Sure, Matt. Yes, we can.

Fantastic. Okay. So I just wanted to ask you for some more color on the progression through the quarter. And the reason for the question in that way is I want to understand how things were coming back as a proxy for how they could come back again after the Delta variant passes. So can you give us any color on how strong things got in July before you saw the impact? Or help us understand what the impact was in the second half of July.

We were working through the prior wave's backlog fairly quickly, and we continue to see improvement from our last earnings call. So we had -- May was better than April, June better than May, July better than June. And it wasn't until the last few weeks of the month that we started to see the pullback. And again, it was -- it's isolated to -- where we're feeling it is more in developed countries, the United States being a big one, Japan, Australia, New Zealand. And just using the United States as an example, it's really limited to the areas geographically in the U.S. where you have lower vaccination rates. It's that simple. And where you have higher vaccination rates, we're not seeing it.

The other thing that it's -- if you look at like a Venn diagram of concentric circles, it's those geographies. And then the procedures that we're seeing are just like we saw in the first wave, the ones that slowed down first. It's either the more highly electable ones like Pain Stim or Spine or ICDs or, in our world, cardiac diagnostics, those are more elective, I would say. Or -- and I should say, it's procedures that require an ICU stay like a TAVR procedure. So those are the ones that we're seeing it, the pullback. And it's in those regions of the United States, to use that example, where vaccination rates are lower.

And again, hospitals are better equipped. Karen already went through, we think this is going to peak here at the end of August, the kind of the hospitals, the infection rates, if you will. Hospitalization rates will trail that by a couple of weeks. We do think this is shorter-lived and easier managed than the prior waves.

So I mean, that's been the progression. So it hasn't quite peaked yet. And like I said, we didn't start seeing the -- I would say, the pullback until the last 2 weeks of July. And at that point, we were pretty much back to either 100%, in some cases over 100%, of pre-COVID levels in our therapies.

We'll take the next question from Larry Biegelsen from Wells Fargo Securities.

So for Sean. This quarter, I probably got more questions on renal denervation than anything else related to Medtronic. So I guess my question is, Sean, when will you know if the interim look is positive? What's your confidence that it will be positive? And if it doesn't end on this interim look -- at this interim look, when will the trial end? And any read-through from that TRIO trial, which was another ON MED trial that showed about a 4, 4.5 millimeter mercury difference on ambulatory systolic blood pressure.

Sean, you're on mute.

Can you hear me now?

Yes, we can. You were going strong, but no one can hear you.

Listen, we don't really -- we have no information...

(technical difficulty)

We lost Sean again. Okay, this is like our fifth earnings call, it's our first technical glitch. So I was feeling pretty good. I'll see if we can get back, Sean. There you go.

While he's trying to get back on, look, he was starting to say, Larry, we really haven't gotten new information since the last call we had with you. We do anticipate, because of the Bayesian trial design and how it's set up, that we'll get -- we know we'll get another interim look here in the fall. And look, there's reason for optimism here because part of the denominator going in to the trial was the feasibility work that we did, and we know what those numbers look like. And it's part of a -- look, we still have existing registries out there. And the body of evidence just continues to build even outside through our registries and other activity that's going on that leads us to believe that it's positive. But look, this is why we do these trials.

And then the next look, that's the question, Sean. I don't know if you're back on, Sean, but if this interim look doesn't -- isn't -- doesn't get to where we need to get to, what's the next interim look after the fall here?

Yes. So can you hear me now? I'm back.

Yes. Yes.

Yes. Larry, so it really is dependent on between group difference and standard deviation. So we don't have a fixed date, it will be this time or that time. It sort of gets there when it gets us there.

If it puts your mind at ease at all, we had the same situation going on with the SURTAVI trial, if you remember that. That was also a Bayesian design. It didn't reach a statistical significance on its first interim look, but it did on the second one. And then of course, 2-year results were almost identical to that when they finally rolled out.

So it will just be pushed down. There still are 3 looks at this. But as Geoff said, we're confident we're going to get there for everything we do now, but we don't know any until the events committee lets us know that we're good to present. So that's our plan. We're going to that, and we'll go from there.

And the read-through on TRIO, look, it's good to deliver a positive sham-controlled study. And I don't think the patient population and drug regimens are comparable necessarily. So it really isn't a read-through.

The next question comes from Vijay Kumar from Evercore ISI.

Congratulations on a solid start to the year. Geoff, maybe one on the product side. Can you remind us on the U.S. time lines for approvals on Hugo, S-ICD and Diabetes? And I'm curious now that you're placing Hugo, what has been the early learnings so far? Has it been in line with expectations or perhaps surprised you to the pause there?

Sure. I'll let just to cue up Bob on some of the more specifics of Hugo and Sean on some of the cardiovascular timing there. But look, I'll just say, look, you saw the video. And we were just out -- the surgeon feedback has been great. Very excited.

And look, as I talked to other health systems around the world, there's definitely an appetite. They want us to win here. So that's a positive sentiment. So demand is high. Surgeon feedback initially is strong. And we just had our whole leadership team out to one of our operational centers here for the Robotics business. They have a couple of R&D centers around the world and a large operational center in Connecticut. We were just -- our whole ex com was there, and they've just made so much progress. And I mean, it's -- we're feeling pretty good right now. But Bob has -- I'll let Bob give you more of the specifics.

Yes. Thanks, Geoff. And Vijay, thanks for the question. We are, with the first cases behind us, really energized by the possibility that Hugo is going to bring to us. And like Geoff said, the surgeon and the OR staff who've experienced Hugo has been super positive. And what they've liked most, Vijay, is really the core to what's to our system design, the modularity, the open console, the 3D visualization, the flexibility of the platform. And they're really starting to think about ways that they're going to be able to apply the technology to expand robotic-assisted surgery.

And the other thing, Vijay, I'll share with you, Touch Surgery Enterprise, you'll recall, our acquisition of Digital Surgery a couple of years ago, has been used in all the Hugo cases and the surgeons are really impressed by the analytical capabilities, the benefits of the video storage capabilities, case sharing and the like. So really excited on the feedback.

And then the first part of your question, with respect to U.S. commercial improvement, it's really going to depend on the time to complete the clinical trial and the FDA review. And as Geoff mentioned as he kicked off the session today, we're making really good progress on our EXPAND Euro trial. We're gaining ethics committee approval, working through the IRB, conducting site training, getting clinical study site activation. And for competitive reasons, I'm not going to go through all the sites, but we're really excited to treat our first patient in the U.S. So we're feeling good. And look, we're on the path of building a multibillion-dollar Surgical Robotics business, Vijay. So Geoff, back to you.

Okay. Thanks. And I think Vijay had a question on the EV ICD, Sean. Like I think it was the timing of the approval there, I believe, Vijay.

Yes. So Vijay, (inaudible) CE Mark this quarter. The Hugo trial for the U.S. approval is currently enrolling. We think that we should see the CE Mark some time in the first half of calendar year '22 and (inaudible) [entry within] approximately a year later.

The next question comes from Travis Steed from Barclays.

Congrats on a good start to the year. I did have another question on renal denervation and thinking about the adoption curve, if the data looks something like the pilot study. What's the process to get payers on board? How do you build the referral channel? And how quickly could revenue ramp? And if you think about the MCIT, the delay there, do you actually need that to get to that $1 billion RDN market size in 2026?

Sean, do you want to take that?

Sure. Thanks, Geoff. Yes, thanks for the question. You're right that reimbursement is the most important thing we have to get right, so a few things. So we have regulatory approvals in CE Mark countries right now. And we have now the European Society of Cardiology is of hypertension put out a statement in July, recommending already as part of the treatment paradigm. Those kind of things as guidelines, recommendations and society recommendations important for payers to make their considerations.

In the U.S., you're right, MCIT would be the best way to get the coverage approved. That has been delayed by the change in administration, it's under review right now. But our plan really would be whether or not MCIT gives you the cover that we just go the same way we do it in every other therapy, we're building it pair by pair, geography by geography, including the United States where you have to get into the payment and the coding as next steps.

So there is a good proportion of the patients that are going to be commercial insurance anyway. And we've been doing that work and it was part of the reason why we built up the clinical trial strategy the way we did, showing patients on medications. So it is going to be in the commercial world, payer by payer and it's going to be for Medicare. We get the MCIT ruling, we'll have coverage by the way, and we'll work on payment coding there. But it's hard to handicap just how fast (inaudible) goes because we don't have clarity on that last point.

We'll take the next question from Josh Jennings from Cowen and Company.

Maybe a question for Sean on the TAVR franchise and just interested to hear -- sorry, multipart question, but interested to hear about how the marketing efforts and the data that's coming out on patient, for a specific patient mismatch, the customer like technique, bringing the pacemaker rate down. And we launched Evolut TAVR FX here in the U.S., expectations for share gains in the U.S.? And then maybe any updates on the timing of low-risk reimbursement in Japan and any high-level views on Medtronic's thrust into China? I think you'd share on market size and just time lines there for Medtronic's TAVR franchise.

Yes, sure. So we have picked up share in the United States as well as in Europe recently. And I think that customer overlap lowering the pacemaker rate increase the predictability of the procedure has been really helpful.

In Europe, we launched the PRO+ just recently. We got also approval, as you know, in Japan for the low-risk indication. Typically, it's about a quarter before the reimbursement gets in line with that.

And of course, China is an opportunity for us. We've been working on a local clinical strategy there and we have good progress going. There's a lot of (inaudible) our solution. That will push -- China is a little bit of a nascent market yet for TAVR. It's still a good growth curve, but it's restricted to just a few centers within the very big cities at this point in time.

Really the penetration into low risk everywhere, particularly in the United States and Europe continues to be the biggest growth driver. And of course, we expanded to (inaudible) patients in the future analogies going. Everything is looking pretty in TAVR, but the COVID challenges that happened because of the concentration nature of that business in the short run. I feel really good about where we are in the pipeline. FX is going to be a really big improvement and the predictability of what we do. That's been one of the biggest and tough for people to learn if they come up with expandable, that stability of the implant market bands on exactly where it's being placed, of course, the new implant technique has been really a home run for us.

Next, let's go to the line of Anthony Petrone from Jefferies.

Two quick ones. Just on the commentary on U.S. procedure volumes, tracking either at 100% or slightly above in certain categories. And so I guess as they bring through there at the midpoint in August that were once again it's on discount to 100%. If so, where does that settle?

And then just on Diabetes, a few quick follow-ups to Vijay. 780G launch in Europe, is that still on track second half? And then the 780G clearance as well as iCGM designation for stand-alone sensors, is that still expected in the second half?

I'll let Sean answer the diabetes questions. But on the procedure volumes, yes, like we said, we believe the cases like, if you will, the COVID cases peak some time at the end of August, early September. And then hospitalizations lag that by a few weeks. So that would peak kind of mid-September. And then we would make up those cases, hopefully, over the course of the year. But we would start getting back to those pre-COVID levels.

I'll just point out that our guidance does not assume that we make up these cases, but that is a possibility here given the -- how quickly we recovered the cases during the prior waves that were much worse than we anticipate the Delta variant being. But that's on the procedure volumes.

On Diabetes, you mentioned 780G in Europe. That is already approved. So I don't know if you meant to say U.S., but in Europe, the 780G is on the market and doing really well. And that's -- we're optimistic because we're seeing the performance in Europe. And the best time and range of any pump and the user feedback and the physician feedback has been off the charts positive. So we're excited about that.

But you had a few other questions there about iCGM. And maybe I'm assuming maybe your question was 780G in the U.S. though. Maybe, Sean, do you want to take those?

Yes. Thanks, Geoff. The combination of the 780G with the sense that doesn't require confirmation, call it non-adjunctive has been filed in the United States and we're seeing really good interactive back and forth with you. That's really good. But that Europe launch right in the second quarter where you have a no finger stick sensor mix were infusion set and 780G. It's really a nice combination. Of course, we'd love to bring that to the U.S. as soon as possible. But things are on track as far as we can tell. As you may know, that division of FDA has been very busy with COVID, so it's hard to handicap exactly when time lines happen. But we do think making good progress in (inaudible).

Let's go next to Matt Miksic from Crédit Suisse.

So just a follow-up on some of the comments you made on sort of the COVID pressure in the U.S. and elsewhere. Just if you could maybe give some additional color around what the strengths and weaknesses look like regionally, whether you're seeing so far any indication. I know bed availability and capacity is one element and, of course, patient sentiment, willingness to get cases done is another. So wondering if you're seeing anything there. I appreciate the additional color.

Thanks, Matt, for the question. So in terms of regionally, the impact that we're seeing is mostly in the United States, and we've talked about that. We do have Japan and certain countries in Asia Pacific like Australia, New Zealand and Vietnam, being impacted because lockdowns are still in place there. In Europe, we're seeing the impact in the U.K. And in Latin America, we're not seeing a big impact on the Delta variant at this point. So hopefully, that's helpful.

In terms of patient sentiment and the impact around capacity availability, we do expect this impact to be short-lived. And really, it's because hospitals are better equipped, as Geoff talked about; vaccination rates are increasing around the world; and patient sentiment is understanding that we need to have life go on with a COVID variant. And so we're seeing that. And so we do expect the recovery here to be faster certainly than it was in the first wave and even in the second wave.

Yes. On patient sentiment, I would say it's much better than it was a year ago, right? There was a lot of unknowns. There was no vaccination. I think you're seeing a lot of people that are -- have a concern have gotten vaccinated, and there's others that have not that have a different viewpoint on the virus. And -- but all in all, patient sentiment is in a much better spot. And as Karen pointed out, hospitals are much better equipped.

We'll take the next question from Jayson Bedford from Raymond James.

Question perhaps for Karen on op margin. Are you still expecting $400 million negative impact to op margin for the year from the investments in Hugo and RDN? How much of that was realized in 1Q? And then just on 2Q, op margin looks like it's in that 25.5% to -- or sorry, 26.5% to 27% range. Is that fair?

Yes. Thanks for the question, Jayson. We are still expecting strong investment against both RDN and the robot. And yes, a $400 million impact to operating margin for the year from those 2 very important programs, which represent what we believe to be the largest opportunity in med tech.

In terms of how much that hit in the first quarter, we expected some ramps in those investments plus others in the first quarter. And we didn't see all of those ramps in the first quarter. So we're expecting more in the second quarter just because of the fact that we're hiring lots of people and it takes a little bit of time. So we are expecting that ramp in the second quarter and in the third quarter beyond that.

What I would say in operating margins for the second quarter is that we'll still expect a few hundred points, basis points improvement in operating margin for the second quarter. So despite all of that investment, we still expect very strong year-over-year improvement.

We'll take the final question from Danielle Antalffy from SVB Leerink.

Congrats on a good start to the fiscal year. Geoff, just a question on the M&A strategy. Congrats on the Intersect deal. I think it makes a ton of strategic sense. I guess just at a high level, is that how you should be thinking about the approach to M&A going forward, more on this sort of in this tuck-in vein? And if you could comment on where, now that Intersect's in the fold, where else we should be thinking about Medtronic looking to fill gaps?

Well, yes, thanks for the comments and the question, Danielle. Yes, look, I mean, the tuck-in strategy is definitely is the one [is that we're focused on] and it's been consistent with what we've been doing over the last couple of quarters. I think we've done 7 deals over the last 1.5 years or so for about $2.3 billion. This one, roughly $1 billion, is one of our -- this is the kind of deal I would see -- I would expect from us. This one happens to be earnings neutral in the first 12 months and accretive thereafter. It's accretive to our weighted average market growth rate. The segment within ENT is growing in the mid-teens. And the returns are strong, well, well above our weighted average cost of capital. So these are the kind of deals that we'd like to see there, and in areas that were strong. So the ENT is one of our stronger businesses, as Karen pointed out in her opening remarks.

So yes, so in terms of where to look beyond, I mean, that's tough to forecast. I'd tell you this, we are looking at all of our different operating units and the different segments that they serve. We spent a lot of time and resources looking at different opportunities and engaging different companies. And yes, so we've got opportunities across the portfolio, and it's difficult to predict where the next one will be. But it will -- we are still very focused on this tuck-in strategy.

And I'd like to say that we're not buying growth here. We're growing what we buy. We buy these earlier-stage companies, and there tends to be a lot of synergies that drive growth, whether it be technical or clinical, or a big one would be commercial, especially outside the U.S. since a lot of these companies tend to be U.S.-based, these start-ups. So that's how to answer that. And hopefully, we can continue to keep this going because it does add to our weighted average market growth rate.

Geoff, please go ahead with your closing remarks.

Okay. I will. Thanks, everybody, for the questions, and we definitely appreciate your support and your continued interest in Medtronic. And look, I hope you'll join us for our Q2 earnings webcast, which we anticipate holding on November 23, where we'll update you on our continued progress here. So with that, thanks for watching today. I hope you enjoyed, the drum line is back. Please stay healthy and safe, and have a great rest of your day. Thank you.