美敦力 (MDT) 2021 Q2 法說會逐字稿

Good morning, and welcome to Medtronic's Fiscal Year 2021 Second 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 Chief Executive Officer; and Karen Parkhill, Medtronic Chief Financial Officer. Geoff and Karen will provide comments on the results of our second quarter which ended on October 30, 2020. After our prepared remarks, 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 a divisional and geographic revenue summary. We also posted an earnings presentation that provides additional details on our performance, which can be accessed from 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 are given on an organic basis which adjusts for foreign currency. There were no acquisitions made in the last year that had a significant impact on our quarterly revenue growth. All references to share gains or losses are on a calendar quarter basis unless otherwise stated. Finally, reconciliations of all non-GAAP financial measures can be found on the attachment to our earnings press release or on our website at investorrelations.medtronic.com.

And with that, let's get started.

(presentation)

Hello, everyone, and thank you for joining us today.

Our Q2 results were significantly stronger than Q1 and came in well ahead of our expectations. Our recovery from the depths of the pandemic has been faster than expected, and we're now approaching year-over-year growth. Now while we continue to monitor COVID resurgence around the globe, health care systems are by and large better prepared and patients are more willing to seek the care they need. Obviously, there's some near term uncertainty, but I am encouraged by the steps we've taken over the past year to position Medtronic not only for continued recovery, but to maximize our performance over the medium and long term.

Now building on the strength of our pipeline, we're going on the offensive and winning share in several of our businesses. We're investing in opportunities to create and disrupt big markets, and we're seeing the results. We're supplementing our pipeline with an increasing cadence of tuck-in M&A. And we're in the process of implementing our new operating model and reenergizing our businesses with a competitive focus on market share and being bold. All of this is aimed at accelerating our growth and creating value for society and for our shareholders.

Now like last quarter, I'm going to lead off with a discussion on market share. And I'm pleased to note that we're winning share in an increasing number of our businesses, our pipeline is coming to fruition and we're benefiting from recent product approvals across the company. Since last quarter, we've received 50 product approvals, bringing our total to over 180 regulatory approvals in the U.S., Europe, Japan and China since the start of the calendar year.

We're also benefiting from the actions we took earlier this year to partner with our customers through the pandemic. We've helped our customers in areas such as environmental safety, hospital productivity, patient engagement and remote monitoring and support. And these partnerships are leading to increased market share in a number of accounts.

In Cardiac Rhythm, we're notably outperforming the competition. We estimate we've gained nearly 2 points of share year-over-year. Our pacemaker product line grew 6% globally as our Micro leadless pacemaker family continued to perform extremely well, growing 75% globally and 84% in the U.S. Micro is now annualizing at approximately $350 million. We also continue to see the benefit of our recently launched Cobalt and Crome high-power devices with BlueSync distance programming and a patient app for remote monitoring. These are both important features in the current environment.

Our CareLink remote monitoring adoption is up 10% globally. And transmissions on our unique CareLink Express system, which enables unattended in-clinic follow-ups, increased 40% quarter-over-quarter. Our CRT-D product line grew 4%, driven by the Cobalt and Crome launch and our improving replacement cycle.

In addition, we're continuing to see strong adoption of our TYRX antibacterial envelopes, especially important during a pandemic, where there's a renewed emphasis on avoiding infections of any kind. TYRX revenue more than doubled, and it is utilized in over half of our U.S. CRM implants.

In cardiac diagnostics, we estimate we gained modest share year-over-year as the launch of our LINQ II is offsetting Boston Scientific's entry into the market.

In drug coated balloons, we grew in the high single digits and gained share both year-over-year and sequentially. We're seeing strong adoption of our IN PACT AV DCB, driven in part by its pivotal data that was published earlier this fall in the New England Journal of Medicine.

In Surgical innovations, we held share year-over-year, and our share is up nearly 1 point versus the prior quarter, driven by strong gains in Advanced Energy. We're earning share with superior products like our LigaSure exact dissector and our Sonicision curved jaw ultrasonic dissector. We're also winning back share from reprocessors.

In Advanced Stapling, our share was down year-over-year with difficult comps given J&J's recall in the prior year. However, we did gain share sequentially on the strength of our Tri-Staple technology.

In our Restorative therapies Group, we're beginning to see important share gain from recent product launches. Starting with Pelvic Health, we estimate we regained 8 points of share in the U.S. and 2 points in Europe sequentially from Axonics. This is the result of our very successful launches of our InterStim Micro rechargeable device and our SureScan MRI leads.

We're quickly recapturing share in the rechargeable space with Micro as we get on contract in more and more accounts. From our FDA approval in August to the end of October, we believe our share of the U.S. rechargeable market has gone from 0 to over 50% in just three months. And we continue to see high trialing rates at 125% of pre-COVID levels, driven in part by our basic evaluation lead, which is a strong leading indicator of future growth.

In Pain Stim, we continue to see strong momentum as the markets adopt our DTM therapy on our Intellis platform. While we're facing headwinds in replacements, given where we are in our cycle, we estimate that we gained new implant share in the U.S. Also, our new SCS implants in the U.S. grew in the high single digits in the quarter, and we saw strong trialing increases year-over-year, a leading indicator of future growth in this business. Importantly, we're seeing the majority of our new implant and trialing growth coming from competitive accounts as we win share from competitors. This is all being driven by the strength of our DTM data, which showed superiority over conventional stim at 3 months, but we've strengthened this evidence last month when we showed DTM superiority that is sustained at 12 months.

In Brain Modulation, we're building momentum with our Percept PC device, the first and only DBS system that can sense brain signals. Now we launched Percept in the U.S. This past quarter. While our U.S. share was down year-over-year, Percept drove increasing new implant share gains each month as we went through the quarter, returning Brain Modulation to growth.

In ENT, we gained share both sequentially and year-over-year. We launched several new products in the quarter, including our next-gen nerve monitoring program, NIM VITAL; our PTI system for parathyroid detection; and StealthStation FlexENT, our new nav system to support outpatient ENT procedures. And going forward, we expect these launches to continue to drive share gains and market growth.

In Neurovascular, we had a good quarter in aspiration, coils and access, resulting in overall growth for our Neurovascular business. While we had share loss in flow diversion due to new entrants in the U.S. market, we estimate that our share in neurovascular increased overall as we won share from both Penumbra and Terumo.

Now turning to the businesses where we are holding share, we estimate that our procedure share was steady in both drug-eluting stents and TAVR on a sequential basis.

In DES, we were one of the winners in the Chinese national tender, and we'll receive volume that is being reallocated from our multinational and local competitors whose tender bids were not accepted. While our volume will increase significantly, this will be more than offset by significant price declines as dictated by the tender. This will impact our business over the coming quarters. That said, we believe participating in the Chinese stent market is a long-term strategic opportunity as our increased access to more Chinese hospitals will provide opportunities to pull through our full product line today as well as in the future with products like TAVR and renal denervation.

Speaking of TAVR, we held procedure share in the U.S., Europe and Japan sequentially. We expect to be back to gaining share year-over-year in the U.S. next quarter as we anniversary our share loss from our fiscal third quarter last year. The market is responding to our competitive messaging on our valve hemodynamics, which is a key determinant of valve selection in low-risk patients. We're also getting favorable customer response to our data in bicuspid patients, which make up a large portion of the low-risk population. And we're continuing to increase our field personnel and open new accounts in the U.S., which we expect to lead to share gains going forward, both from Edwards as well as winning share in Boston Scientific accounts, given their recent decision to remove their LOTUS valve from the market.

In MITG, we estimate we held share in both GI and respiratory. In respiratory, we saw strong acceleration in ventilator sales, with our revenue increasing nearly fourfold year-over-year and growing nearly 50% over Q1. This is driven by our ability to increase production and shift our mix to our high-acuity PB 980 ventilator to fulfill back orders and meet customer demand, particularly in the U.S. and Europe. We do expect ventilator revenue to decline sequentially in the back half of our fiscal year, returning to more normal levels in FY '22.

In spine, we estimate that we held share year-over-year with a slight gain in the U.S. We're seeing strong double-digit growth in our Surface enhanced titanium interbodies that came from our acquisition of Titan Spine last year, which is now in our organic results. In spinal robotics, while large capital equipment purchases continue to be pressured as a result of COVID, we estimate that we sold over 1.5x the number of robots that Globus did. We continue to grow our share in the spine robot market, which is a good leading indicator of our future spine implant sales.

In addition, we're expanding the capabilities of our Mazor X robot. We received approval earlier this month for our navigated interbodies as well as our Midas Rex high-speed power drills.

While we're growing and holding share in many important businesses, there are also areas in which we are losing share and we're working to improve.

In Diabetes, we've discussed with you our plans to return this business to market growth, and we're seeing positive early signs as we lay the groundwork to create a business that can compete and win. We performed better-than-expected in Q2, but there is much more to do, and we're laser-focused on doing what it takes to return to market growth.

The MiniMed 780G launch is off to a great start in Europe, and we just started the limited release of the 770G in the U.S. last week. As a reminder, we plan to enable 770G users to upgrade their pump to a 780G through a software download once we get 780G approval.

We're also pleased by the recent CMS proposal to cover all CGM devices. If finalized, it would ensure patients transitioning into Medicare have continued coverage for their integrated CGM and will open up the U.S. Medicare market to our closed-loop insulin pump systems as early as April.

Regarding Companion Medical, the acquisition closed in September, and we're excited to have the team on board. Companion revenue was minimal in Q2, but we expect it to become more meaningful going forward. We announced the integration of our CGM data into the Companion InPen app 2 weeks ago. This will allow InPen users to have their Medtronic CGM readings in real time alongside insulin dose information, all in one view. We were able to deliver this solution ahead of schedule in just 2 months instead of 2 quarters, and this speaks to the strong integration work that is happening between our Diabetes team and Companion Medical. It's also a great example of how Medtronic is operating with speed and a sense of urgency across the company.

Now let's turn to our pipeline, which has a number of future opportunities for us to win share as well as create and disrupt big markets. We covered this in detail with you last month at our Investor Day, so I'm going to give the abridged version today.

Starting with CVG. We continue to make good progress on several opportunities highlighted at Investor Day. It appears to have been missed by The Street last week, but last Monday was a huge day for the treatment of AF. Our Arctic Front cryoballoon was the subject of a simultaneous AHA data presentation and New England Journal of Medicine Publication that promises to redefine the role of our cryoballoon technology, making it first-line therapy in the treatment of paroxysmal AF. We currently have CE Mark for this indication and anticipate FDA approval in the first half of next calendar year.

Regarding our DiamondTemp cardiac ablation system, it continues to roll out in Europe, and we're targeting a U.S. launch in the first half of next calendar year.

Also in CVG, we're enrolling pivotal trials for our Extravascular ICD, our Intrepid transcatheter mitral valve, our PulseSelect pulsed field ablation system and our Symplicity Spyral renal denervation system.

Now Ardian represents one of our biggest opportunities to become an important therapy to treat the millions of patients around the world who struggle with hypertension. We're aiming to complete the on-med trial and present the data next calendar year.

In MITG, we're excited about bringing our soft-tissue robotics system to the market. We continue to expect to file for CE Mark and U.S. IDE approval in the first calendar quarter of 2021. Although these filings are likely to occur later in the calendar quarter as COVID is slowing some of our on-site activities.

In RTG, we're making large investments in new products for neurovascular and ENT and in enhancements to our Mazor X spinal robotic system. We're also focused on expanding indications in spinal cord stimulation and bringing to market our steerable lead and closed-loop system in DBS.

In Diabetes, we continue to work with the FDA on the most efficient filing strategy for the 780G. While on the sensor front, we submitted our Zeus sensor to the FDA in October. And we've completed our Synergy pivotal trial and will file it when we complete the manufacturing module. We continue to get great feedback on Synergy, which is disposable, it's much easier to use and half the size of our current sensor.

These are just a few of the many innovative products in our pipeline. We expect them to be the foundation for material future revenue growth. And we're excited to keep you updated on our progress.

I'll now have Karen take you through a discussion of our second quarter financials and our outlook. And then I'm going to come back with some concluding remarks before we go to Q&A. Karen, over to you.

Thank you, Geoff. Our second quarter organic revenue of $7.6 billion declined 1.5% and adjusted EPS of $1.02 declined 22% from last year. However, compared to the prior quarter, our revenue increased 18%, and adjusted EPS grew by 65% as our end markets continue to recover. In fact, we continue to see sequential revenue improvement each month. And despite the number of COVID cases rising in many of our markets, October was better than September in all of our groups and regions, with the exception of China, given the impact of the national tender in drug-eluting stents.

MITG led the way with its growth rate increasing by over 20 points in both Surgical Innovations and Respiratory, GI & Renal. SI benefited from increased elective procedure volumes in Europe and the United States, driven in part by elective procedures that were delayed from the spring and early summer. RGR's improvement came from strong ventilator sales as well as from GI, patient monitoring and Renal care products. Across MITG, we had growth in a number of our businesses in the second quarter, including Advanced Energy, lung health, airways, ventilators and patient monitoring.

CVG and RTG also delivered double-digit improvements from the first quarter with increased procedure volumes and share capture. And several businesses returned to growth from the prior year. In CVG, we grew in pacing, CRT-Ds, TYRX, aortic and drug-coated balloons. And in RTG, we grew in DBS, neurovascular, Pelvic Health and China orthopedics.

On the P&L, while we continue to see the expected deleveraging year-over-year, the recovery in our business is evident in the sequential improvement in our adjusted margins, over 300 basis points in our gross margin and nearly 600 basis points in our operating margin. Our better-than-expected revenue flowed through to the bottom line, resulting in EPS well ahead of expectations.

Turning to our balance sheet. Our financial position remained strong. In the quarter, we completed another euro debt offering, EUR 6.25 billion, and used the proceeds to reduce our U.S. dollar debt and prefund our March euro debt maturities, driving roughly $80 million of additional annualized savings. This is our third euro transaction in the past 1.5 years. Combined, we have issued over $18 billion, and our portfolio now sits with a weighted average maturity of over 12 years and a weighted average coupon of less than 2%, among the lowest of the large-cap issuers and the lowest among our competitors in med tech.

As I shared with you at our Investor Day last month, we remain focused on investing, both organically and inorganically through tuck-in acquisitions and minority investments to drive our long-term growth strategies. Last month, we announced the acquisition of AI Biomed to expand our ENT portfolio. In addition, we closed our acquisition of Avenu Medical in peripheral vascular earlier this month. And we announced the completion of our Medicrea acquisition in spine last week.

We expect both our organic and inorganic investments to fuel a longer-term revenue growth acceleration, ultimately creating strong returns for our shareholders, supplemented by our strong and growing dividend. We are an S&P Dividend Aristocrat, having increased our dividend for 43 years. And our current yield of 2.1% places us in the upper quintile of S&P 500 health care companies.

Now turning to our outlook. Particularly with the rising cases of COVID around the world, the impact to our business remains difficult to predict, so we will continue to not provide our typical guidance. That said, I do want to give you a sense of the recovery ahead. While it is still early in our third quarter, we've seen our average weekly sales track ahead of the same weeks in the second quarter. So while there are pockets of more restrictions and delayed procedures around the globe, the impact to us has thus far been limited.

As we've said before, hospitals are better equipped now to handle COVID patients and remain open to serve non-COVID patients. And over time and with education, patient fear is not as heightened as it was last spring and early summer. While there is still uncertainty ahead, if the recovery trend continues as it has to date, our third quarter revenue could be flat to slightly up year-over-year on an organic basis. And we would continue to expect to return to normal organic revenue growth on a 2-year stacked basis by our fiscal fourth quarter.

By group next quarter, MITG growth could be in the low single digits, a little lower than the second quarter given the benefit we had from strong ventilator sales. RTG and Diabetes should deliver improvements from the second quarter with a decline in the low single digits. And CVG should be roughly flat as we continue to recover and take share.

On the P&L, while we are continuing to invest in our product pipeline and launches during the pandemic, we still expect sequential operating leverage as we recover. For both our gross and operating margins, we would expect a couple of points of improvement in the third quarter versus the second. And we continue to expect to return to more normal operating margins in the fourth quarter.

Regarding currency, assuming rates hold constant, the tailwind on revenue in the third quarter should be similar to the second, and the full year benefit could be roughly $150 million. On the bottom line, we'd expect a $0.04 headwind per quarter for the remainder of the year.

As I wrap up, while the pandemic could impact our outlook, our ability to continue to invest in our pipeline, develop our markets and execute on product launches will allow us to outpace our markets. I'm proud of the hard work from our employees this year, and I'm excited about the impact we are having on millions of patients' lives around the world. With our competitive spirit and focus on being bold, we will be at the forefront of the recovery.

Back to you, Geoff.

Okay. Thank you, Karen. Now to wrap up. I hope you're seeing the strong execution that our organization's delivering. I want to take a moment to thank our employees across the globe for the great performance they have collectively produced this quarter.

To sum up the second quarter, we're improving our growth, advancing our pipeline and winning share. And we're doing all of this while operating in the midst of a global pandemic and while we make bold and comprehensive changes to our operating model.

And one last note regarding our operating model. We're making solid progress on decentralizing and delayering our businesses. We're empowering our 20 operating units, gaining greater visibility into our end markets, upping our competitive game and holding our business leaders more accountable. We're leveraging the strengths of our enterprise by centralizing manufacturing and certain core technology development. We've increased our focus on allocating capital to our best opportunities, and we're supplementing this with an increased cadence of tuck-in acquisitions. And we're enhancing the culture of this company by increasing our competitiveness and being bold, adding these on top of all the great attributes of our mission-driven culture. We expect this to lead to more innovation, accelerate our growth and unlock a lot of value for our shareholders.

So with that, let's now move to Q&A.

(Operator Instructions) Please also be advised that this Q&A session is being recorded. For today's session, Geoff Martha and Karen Parkhill are joined by Mike Coyle, EVP and President of the Cardiovascular portfolio; Bob White, EVP and President of the Medical-Surgical portfolio; Brett Wall, EVP and President of the Neuroscience portfolio; and Sean Salmon, EVP and President of the Diabetes operating unit.

I'll now turn it over to the moderator, Ryan Weispfenning. Please go ahead.

Great. Thank you. Let's first go to the line of Bob Hopkins from BofA Securities. Bob?

Great. So the first question I'd love you guys to comment on is some of the geographic results you showed in the quarter because I found the breakdown really interesting. Specifically, I'd love to hear your thoughts on -- it looks like Europe was up in the quarter, China was down in the quarter. Maybe comment on some of the trends that are driving those results in Europe and China.

And specifically, on the China tender, was that worse than you thought in terms of the final outcome there? And was that tender contemplated when you gave the long-term guidance that you provided at the Analyst Day?

Yes. Thank you, Bob, for that question. We were pleased with the geographic results that we saw. You're right, Europe was up and certain parts of Asia were up. China was down, but that was really due to the national tender. Absent the impact of the national tender, China would have been in strong growth territory.

And on the tender, it was really close to what we expected. We -- it was hard to predict, but we were pleased to be one of the 5 finalists in the tender. So we expect to be gaining share -- or gaining share in volume as a result of that.

Yes just, Bob, on the tender. I'd say, I think it is -- in the -- over the next couple of quarters, it's going to be a headwind because we're going to have a lot of volume increase here, a matter of fact that -- but it's going to be offset by the price decrease. And so -- but we view it as strategic over time because this is going to be the tip of the spear, if you will, for more aggressively taking our commercial organization into the lower-tier cities, the rural cities in China, Tier 2, Tier 3. And it will also help us pull through other products around coronary today, plus in the future, with TAVR and renal denervation.

So not happy about the short-term impact. I think long term, this is, like I said, is strategic. And we'll see the volume. The Chinese government has been reaching out to us and working with us to make sure we're prepared because they're expecting us to have a pretty dramatic increase in volume here. So we'll see how this plays out, but we do think that over the next couple of quarters, it's more of a headwind than a tailwind.

Okay. And then just really quickly for Karen. Your comments on current trends, I appreciated those. I just wanted to be clear. So are you saying that what you're seeing so far this quarter is not worse than what you saw in October in terms of year-over-year growth?

That's correct, Bob. What we've seen in the first couple of weeks in November is higher than what we saw in the similar weeks in the second quarter. That said, the first few weeks of a quarter don't necessarily make a trend. So we'll be closely watching any impact from the COVID surge. I would say that if these trends continue and there's only limited impact from the COVID surge, we do expect our revenue could be flat to slightly up in the third quarter.

Let's next go to the line of David Lewis from Morgan Stanley.

Just 2 quick ones for me. I'll start with Karen. So Karen, the revenue numbers in the quarter and the forward momentum is very impressive. Did -- the drop-through on margins, Karen, in the second quarter was actually weaker than the first quarter. So wondering if you could just talk about where are those investments going? How should we think about drop-through into the back half of the year? And where are we on the cost plan? And then I have a quick follow-up.

Yes. Thanks for that question, David. Clearly, we have been focused on investing for the long term through this pandemic. And as a result, our margins are a little bit more depressed than normal. We have said that we expect to be back to more normal margins in the fourth quarter all along, and we continue to expect that.

In terms of the drop-through of the additional revenue, we did have some period expensing on the manufacturing front as well. Similar to last quarter, we expect that to not be a headwind next quarter. And we continue to invest below the gross margin line, particularly as we're focused on driving the right commercial launches of some of our new products. And so we're focused on investing appropriately and ultimately getting our margins back to normal by the fiscal fourth quarter.

Okay, very helpful. And then, Geoff, maybe for you. I mean, there's been $1.6 billion of balance sheet deployment over the relatively near term. Over the next 6 to 12 months, should we expect a similar cadence of deals? Should we expect sort of higher or lower?

And then if -- Karen, if there's any sort of quantification across that $1.6 billion in terms of what the revenue impact could be here over the next 6 months or so, that would be super helpful.

Yes, David, on the M&A, it's -- obviously, it's hard to predict, right? I mean -- but I would suspect a similar cadence of these tuck-in type of deals. Again, it is hard to predict. But it is, like I said, part of our strategy. It's something that we're looking to do to augment our R&D.

Yes. And David, in terms of the revenue contribution, much of what we bought this year are really early stage tuck-ins. And it goes along the lines of grow what we buy, don't buy growth. So these acquisitions are really expected to be larger contributors to revenue in the years ahead. The combined expected revenue contribution for the rest of this fiscal year is small. And we'll obviously evaluate. Whenever revenue from an acquisition becomes meaningful to a business, we will certainly adjust it from our organic results until we anniversary that.

So the one that we may end up adjusting for starting in next quarter is Companion Medical because it could be impactful to the Diabetes business alone, but certainly not to the total company.

Let's next go to the line of Robbie Marcus at JPMorgan

Congrats on a nice quarter. I was looking at Diabetes, which to me is one of the businesses that could have the most upside potential if your turnaround plan works out. I was hoping you could walk us through maybe the next 6 to 12 months in terms of new product cadence, how that should impact numbers.

And also, I know you'd been deferring pump sales for a long time waiting for 780G in the upgrade program. How do we expect that to play out into numbers over the next 12, 18 months, when 780G hits the U.S.?

Sure. Robbie, I will turn that one over to Sean with one edit: Not if it happens, but when the turnaround happens. So Sean will talk to that.

Great. Thanks for the question, Robbie. So over the next 6 to 12 months, really, the focus is going to be on rolling out the new pump platforms. We are off to a really, really good start for the European launch of the 780G. So we're in, I think, now 12 countries. We'll continue to roll those out as time goes on here.

And the 770G, as Geoff said, just started its initial launch in the U.S. We've had really strong demand for that as we've got a number of these upgrade pathways in place. So the pathway upgrade from an existing 670G as well as a next-tech pathway to get people to come into the new pumps. We've seen an increase in the proportion of patients as new starts in the U.S. as compared to just replacements of in-warranty patients coming out of the warranty.

And of course, Companion Medical is going to be a big focus. We've got now the integration with our CGM in real time, which is a big deal. As we improve the sensor experience, that's going to get to be even more of a big deal. But more importantly, we've now trained up and have the entire sales force with this in their bag now in the U.S. as opposed to just the small sales force that came with the Companion acquisition.

So I think in the near term, those are the priorities. But you roll that forward into what's next? Obviously, the 780G launch in the U.S. is a big deal. The Zeus sensor globally would be a really important driver for us.

And then a smaller product, but an important one, we just started a limited launch in Finland. It's for a 7-day infusion set. So this allows you to wear this infusion set for almost twice as long as what is normally required. And that product will arrive at the U.S. We've just locked the database on that, so we should expect that to be part of the mix going forward.

Of course, all of this flows. So you have the hardware out there. It's upgradable by software to 70, 80 and beyond. You've got the compatibility designed in for the sensor pipeline as well as extended-wear infusion set. So I think we're setting up for really a nice cadence of products, and that will drive us into growth.

And maybe just a quick follow-up. Karen, there's a lot of nuance as we look out to fiscal '22, which is where I think a lot of The Street is focused in terms of valuation. So anything you could sit here today? I know it's impossible to call the recovery trend when vaccines hit. But anything that you see in models that stand out that you want to point people to as they think about modeling into fiscal '22, whether it's on the top line or the expense cadence?

Thanks for that question, Robbie. It's early. Obviously, we're still 5 months away from starting our fiscal '22. And we're really working on our plans right now. Plus, the pandemic makes it a little more difficult to forecast. So I would say we'll wait to give more color or guidance on FY '22, likely as we normally do on our fourth quarter earnings call. But clearly, you can expect that our growth should be higher than normal next fiscal year off of the depressed base and because we continue to launch our pipeline of products.

Let's next go to the line of Vijay Kumar from Evercore ISI.

Can you hear me?

We can.

Excellent. So I guess I had 2 quick questions, 1 financial and 1 on, I guess, Diabetes.

On, I guess, the financial part. When we're looking at this year-on-year organic growth, could you perhaps quantify what the impact from the move to consignment sales, the move -- the shift away from bulk order was in the quarter? Because it looks like ex those impacts, perhaps organic year-on-year was in the low singles territory, in positive territory. I just want to make sure my math is correct.

And I think I heard you say, Karen, Q-on-Q, you expect margins to be up a couple of hundred basis points. I mean, if revenues are almost flat or up in 3Q, perhaps talk about any margin headwinds for 3Q.

Sure, Vijay. Let me start with the conversation on bulks. We mentioned last quarter that the vast majority of the bulking impact was behind us, but there are still pockets in certain businesses where we continue to look at odd year-over-year comparisons because of bulks. I would say biologics and spine is one of those areas, TAVR is another. But if you look at the total company, the impact from bulks is largely behind us.

In terms of the quarter-over-quarter margins, we said that we expect both gross and operating margins to be up a couple of points sequentially from the second quarter. And so if you look at the Street models, particularly on gross margin, it could be a little higher than what The Street currently has.

Is that answering your question?

Yes, it did. And I guess on -- because I guess, I was confused on the TAVR commentary on share, market share being stable sequentially. And if you look at your closest peer, they were up mid-singles and you guys were minus 6%. So I just want to make sure how you get to the sequential stable share math.

Yes. Vijay, I know and I understand it's a little difficult to track. But why don't we have Mike Coyle walk us through that math there?

Thanks for the question, Vijay. So we would estimate that the overall TAVR market for the quarter was, on a constant currency basis, up around 2%. And as you just noted, our reported numbers on a revenue basis year-over-year are down about 6%. But when you basically consider the U.S. market dynamic of the deloading activity that we -- that's been taking place, where essentially we have shifted away from doing bulk purchasing and have actually moved customers onto consignment who essentially want to hold inventories.

If you look year-over-year, our hospital-held inventories of TAVR product are probably down around $25 million. So that, basically, when you correct for that in terms of just the year-over-year comparisons, we're essentially flat in terms of our global sort of TAVR market. So that's the difference between sort of the year-over-year versus the quarterly comparisons.

As we look in the quarter sequentially from last quarter, we essentially held market share in the United States. On a year-over-year basis, our case volumes were essentially flat with the prior year, which was a marked improvement over what we saw during Q1. And so as we look forward, we're very confident about our ability to take share for a number of reasons. Obviously, the most important of those being the recent announcements from Boston Scientific here late in the quarter, the decision to essentially remove LOTUS from the marketplace. And in addition, from the TCT meeting, the Scope 2 data that basically had the ACURATE neo product failing, it's non-inferiority endpoint on a head-to-head trial versus Evolut R. So that gives us really, I think, an opportunity to take share that they have had, where we have been disproportionately hit here over prior quarters.

And of course, just going forward, the hemodynamic benefits of the product really are encouraging in terms of how the customers are receiving that. We had another great TCT meeting here in terms of new data flow supporting the benefits of hemodynamics from lower pacemaker rates. The [SURTAVI] data was very encouraging in terms of direct comparisons of balloon-expandable to self-expanding valves. And we continue to roll out our cusp overlap technique for lower pacemaker rate.

So all of that, we think, is going to be very helpful for us to continue to take sequential share.

Now the third quarter a year ago, we saw a pretty big dip in share that we've been sort of clawing back. And so you're going to see it in the overall year-over-year numbers once we have anniversaried that Q3 event. And of course, as we get into Q4, we have normalized prior year comparisons for the hospital inventory adjustments that I just talked about. So by the time we get to Q4, we think we look very similar, whether we're looking quarter-over-quarter or year-over-year, in terms of share dynamics.

That's helpful, Mike. And Geoff, one quick one for you on Diabetes. I think you spoke about share gains. Are you seeing anything on, one, you look at the 3Q guidance, down low singles implies an improvement over 2Q. What's driving that?

And are you seeing anything on the pump market side? We're hearing some chat about customers delaying pump upgrades, waiting for the Tidepool algorithm to come -- waiting for the Tidepool algorithms. So perhaps talk about the diabetes pump market.

Sure. Vijay, I'll have Sean. Why don't you jump in on that one?

Yes. So Vijay, I think that there's probably a smaller proportion of the market that is waiting for Tidepool to become available. Really, I think the capabilities that algorithm are really not anything advantaged over what -- that we have in the pipeline and certainly what's available currently in the market. So I think the idea that this would run a base pump and you can kind of pick your components is appealing to some. And to others, quite frankly, having to chase 2 or 3 companies around in order to kind of get your questions answered, track down what your challenges may be, is just not the kind of experience that a lot of people are looking for. And they kind of want a one-stop shop where they can get everything they need and all their questions answered in a single place. And that's, of course, an advantage that will accrue to us as we get our pipeline of products out there.

But I'd say it's really much -- it's more of a niche opportunity and really not a big focus. I don't see a lot of people waiting for it.

Let's next go to the line of Larry Biegelsen from Wells Fargo.

Can you hear me, Ryan?

We can, yes.

Great. All right, great. One for Karen, one for Geoff. So Karen, you talked about operating margins returning to normalized levels in Q4. How do you define that? Is that the 30% we saw in fiscal Q3 2019? Or should we be thinking about 29% for fiscal -- the full year fiscal 2019?

And any comments on consensus EPS for Q3 and Q4 based on the commentary you've given this -- on this call. And I have one follow-up for Geoff.

Great. Thanks, Larry, for the questions. In terms of normal operating margins in Q4, we're thinking about that pre-COVID for the full year, so roughly around the 29% level.

And then in terms of consensus, we clearly talked about revenue in the third quarter, if trends continue and there's limited impact to COVID, being around the flat to slightly up, which is higher than where consensus currently is. And that would flow through down to margins, as we've discussed, approximately 200 bps sequentially higher from the second quarter and so flow through to the bottom line. So that's what I would say on the Q3 consensus.

On Q4, because we've said all along that we expect to be back to more normal growth on a 2-year stack basis and more normal margins. Consensus is roughly right there already.

Perfect. And Geoff, on China, I heard your comments on the drug-eluting stent tender and the pricing there. China is an important market for you, roughly 5% of revenues, I believe. How concerned are you that what happened with drug-eluting stents could spill over to other areas of your business? How contained do you feel that is?

Thanks, Larry, for that one. Yes, China is a strategic market for us, and we are watching this tender process closely.

Anyway, sorry here. There's a beep on the line here. I'll keep going and hopefully that will stop here. Hopefully.

Anyway, in terms of China, we do think it's more contained for us, at least for a couple of reasons. One, the coronary stent business is one of the few businesses at Medtronic that does have less differentiation, I would say, in the industry. The industry itself, the products aren't as differentiated as we see in some of our other segments. And the other dynamic that was unique here is that 80% of the drug-eluting stent market in China was already local. So they had alternatives there. And those 2 dynamics, the differentiation, the lower differentiation and a robust local market, that doesn't exist in most of our -- the segments that we compete in, in China. So we do think it is -- we don't have a lot of exposure to that type of impact from a tender going forward.

And matter of fact, this is where our diversification helps us. We've got a lot of growth levers in China. And I do believe it is -- still remains a bigger -- a big growth opportunity despite some of these tender headwinds.

Let's next go to the line of Matt Taylor at UBS.

Can you hear me okay?

We can.

Perfect. Okay. So I just wanted to ask a question about the progression of utilization. We've seen some stronger recovery here than a lot of us might have expected with the current conditions. We've had a lot of good news around vaccines lately. I'm just wondering conceptually as we go through next year, can you talk about how you expect that to impact recovery?

And could we see a bolus or elevated demand after the vaccines take hold? Or do you think that we've kind of lost some of these patients in the shuffle, and that you won't see that kind of a resurgence?

Thanks for the question, Matt. On that one, right now, like the -- we do believe, to the extent that there is pressure from the second wave, talk or this spike, if you will, it is limited, as Karen said, both in depth and in time. Like I mentioned, pre the vaccine, hospital CEOs, we talk to them all the time, dozens of week. And their narrative has remained the same in that they've learned a lot of lessons on how to safely continue with elective cases despite COVID, and they've been able to treat COVID patients more efficiently. And they believe that, even in this spike, that they will be able to continue elective cases. We are seeing some pressure in some areas. But like I said before and Karen mentioned earlier, we do believe that's limited.

Now in terms of your question of once we get through, once the vaccine is out there, and it's like pretty much an all-clear signal for patients that are considering -- that may have been holding back. I haven't heard anybody yet talking about like a bolus of patients. I think we have worked through, by and large -- there is a little bit of a backlog out there still, but we have worked through a lot -- in our more elective areas, if you will. But by and large, we've worked through a lot of that. And that backlog is relatively small. And we're starting to get back to more of a kind of steady-state run rate here.

And so given all that, I wouldn't expect a big bolus. But we could be surprised. This is -- I wish there were a little more science around some of the numbers that we're -- but we are trying to quantify as much as the feedback we're getting. But I haven't heard anything about a bolus of patients waiting out there for the next year.

Let's next go to the line of Rick Wise at Stifel, Nicolaus.

I'll just ask one question. Geoff, you were very clear at the Analyst Day about your focus on accountability, execution, innovation, the potential for improved growth and margins, et cetera, et cetera, et cetera. Is it -- I guess, just 2 aspects of that is my question. Just should we attribute -- how much of the excellent quarterly performance that we're just looking at is tied to your initiatives, your energy that you're bringing, your new vision you're bringing to Medtronic?

And second, maybe just at a high level, just talk to us about the progress you've made, where you feel like you are. And how you -- how we should think about the Martha plan going forward.

Thanks for the question, Rick. And it would be nice to say that the Martha plan had that big of an impact so quickly. But I think in reality, it is the product launches. That's what's really driving the near-term results. Like I said, the product portfolio and the pipeline, rather, is the best we've ever had. And we've got products launching now, which we listed a lot of those. And then we've got products over the next 18 to 24 months. And the disruptive nature of those products in the next 18 to 24 months in and of itself has created a lot of energy across the company as people can feel the near-term impact of these products.

And things like -- we mentioned in the commentary here, our ablation business, our cryoablation business, being -- with this New England Journal of Medicine data, being now a frontline therapy for Afib. And taking that information and that opportunity and making the most of it, that type of approach is getting people excited. So I think right now, it's really about the product launches.

Over time though, I think the changes that we made, the decentralization, the un-nesting of these operating units, these 20 operating units, and pushing them to be bold, to think big, be bold and maximize their opportunity. And you know what? Don't be afraid to fail.

Or hey, I mean, like, we don't want to fail. But if you're -- if we're too conservative, we're not going to take advantage of these massive opportunities in front of us, like Ardian, like renal denervation, like soft tissue robot, like the example I just gave for our ablation business. It's a -- Afib's a massive underdiagnosed problem here, and we've got all kinds of therapies for this.

So that is creating an energy across the company that I anticipate, over time, will translate into, I'd say, above-market growth and really expand the number of patients that we're serving.

And I'll end on this. We talk about we touch or impact the lives of 2 patients every second. And that's a pretty amazing statistic. But when you do the math, that's like 80 million people a year. Well, there's over 7.5 billion people in the world. And so I'd like to kind of reframe that question. It's like, why are we doing so few given the technology that we have? And really expand that patient base. And that kind of approach is creating a lot of new thinking and energy that I think, over time, will take hold here because we've got big plans here. And -- but what you're seeing now is good. But I think we can do better over time.

Let's next go to the line of Matt Miksic at Crédit Suisse.

Can you hear me all right?

Sure, we can.

Perfect. So just a follow-up on some of the current trends commentary that you've given. We're all watching hospitalizations, and they have increased. And I'd say it sounds like your commentary was perhaps a little bit more optimistic and constructive despite the surge than some folks were expecting, which is great. And the numbers were terrific here in the second quarter.

But maybe if you could talk a little bit about how you're thinking about hospitalization trends and these conversations you're having. And maybe when and if, at what level, they do become a little bit of a concern. Then I have one follow-up.

I mean, basically, Matt, what we're hearing is that 2 things. And it's most of our feedback, I'd say 75% of it, is coming from the U.S. hospitals and then the rest from Europe, I'd say.

But in the United States, in particular, the 2 things that would have to happen, again, given everything we said about the lessons learned and the commitment to hospitals, the commitment to keep elective cases going. The 2 things that could derail them is literally they run out of space from so many COVID patients. And then they -- and it becomes like a real estate issue within the hospital. That would impact obviously, elective cases. They would be deprioritized there. And in some cases, we're seeing that we're getting closer to that level of capacity. So that's what we're watching.

And the second would be some sort of statewide mandate that could happen. It's -- in today's political climate, I think it'd be foolish to try to predict anything. But some sort of statewide mandate could happen as well.

So those are the 2 things. And I think the hospital CEOs and executives are more worried about the first thing. And some of the larger systems have the luxury, that are more regional, of moving patients around, both COVID patients and elective patients. You can move elective procedures from one hospital to the next in some of these larger systems.

So that's -- they're really doing their best to manage those 2 things. But that's why we're, I guess, cautiously optimistic that the impact of this second wave will be limited. That and with the optimism of the vaccine news is another driver here.

That's helpful. And then just to follow-up on your comment on the New England Journal article and the presentation at AHA, the first-line therapy for paroxysmal. Can you talk about maybe how you expect that, how investors should expect that to sort of show up in the numbers? Is it -- is there a penetration pathway here that we can expect to hear more about over the next year or so?

I'll maybe let Mike provide a little more details on that data.

Sure, Matt. Currently, because no ablation therapy is approved for first-line therapy, a patient has to fail a series of antiarrhythmic drugs before they become eligible. And we'd estimate that's about a 2-year period of time, that physicians will essentially titrate antiarrhythmic medications.

And basically, the data that we've shown in the New England Journal said less than half the patients who actually go down that path will wind up being symptom-free. So essentially, you're taking a large portion -- the entire diagnosed portion of patients with symptomatic atrial fibrillation, and you're delaying them 2 years from coming in and losing a lot of them to follow-up therapy. And of course, 45% of them will just stay on the medications.

By basically showing that cryoablation will have 75% of those patients symptom-free in a year, if we can push that into first line. We not only accelerate the curve, but obviously, a lot of patients who wound up on antiarrhythmic will then essentially not require them because they become symptom-free with ablation.

So there's obviously a lot of education that has to take place at the referral channel level. We think these data will be very compelling. To be able to have that take place, obviously, we need FDA approval of the labeling indication, which as Geoff mentioned, we would expect to be in our next fiscal year. But we're very excited about being able to outreach to that referral community with a much better solution for the patients.

This is like a trend that we're starting to see where our kind of definition of market development is expanding to -- not just to the specialist physicians around the world that we're used to dealing with, but to more -- the general practitioners, and in this case, even in just general cardiologists and to the patients themselves. And so this is a muscle that, this kind of hybrid B2C, B2B, B2C, this kind of go to market, this muscle of market development, we need to develop because there's other areas across the company that we're seeing this. Obviously, Diabetes is more in this camp. And this is something that Medtronic, even -- and a lot of med tech historically, haven't done. But I do think it's a muscle we need to develop here.

Let's next go to the line of Chris Pasquale at Guggenheim.

One quick one on Diabetes and one on CVG. For Diabetes, Sean, could you just clarify the expected timing of the 780G U.S. launch? It sounded like there might still be some uncertainty about how you go about the filing strategy there.

Yes, sure. So the situation we have, I think, as you probably already know, is that the FDA's division that regulates the diabetes sector is also involved in a lot of the COVID diagnostics works. So it's really been a resource drain on their part for medical reviewers in particular. So at their request, we're pulling together a lot of parts to that submission, including the pediatric data and not separating that out from just the adult data. So one submission for all patients as well as the integration of the Zeus sensor into that package. So that's the summary of the package, how we can consolidate it down to fewer component parts that need to be reviewed, which will add efficiency for them and time to market for us for the entire package.

Okay. But in terms of when we should expect to have 780G available for U.S. patients, any sense for when that could be?

That's hard to predict, the review cycle time. We're intending to submit that in this quarter.

Okay. That's helpful. And then just quickly on the Chinese tender. The impact there in the back half of the year, you characterized the $26 million this quarter as reserve, which, to me, implies a pulling forward of the headwind. But then you also talked about it continuing to be an issue on a go-forward basis. So how much of the sort of annual impact of that was recognized this quarter versus still to come?

Yes. Thanks for that question, Chris. The reserve impact from the China tender is really because we've got product in the dealer channel, and we needed to compensate for the price that will be impacted in the dealer channel as soon as the tender is effective. So that's what's going on there.

In terms of go-forward, obviously, the price go forward is 95% lower. And so that will continue to impact us. But it was a bit of a larger impact now since we had to do the reserve as well as the shorter impact for the quarter.

Let's take one more question and go to the line of Kaila Krum at Truist.

Can you guys hear me okay?

We can, yes.

Perfect. You guys had mentioned that you're talking to dozens of hospital CEOs every week. So I'm just curious what you're hearing in terms of their appetite for capital spending, and particularly as they're budgeting for calendar 2021. Just any additional color there you can add would be helpful.

Yes. So capital, it is -- obviously, the capital budgets in hospitals are pressured. But we're finding 2 things that are helping us out. One is that our capital tends to be -- is tied, for them, profitable elective procedures like in spine. And so that helps a lot. And the other thing is providing flexible financing options is a second one. So although there is some pressure on just general capital, when that capital is supporting an elective procedure that is profitable and critical to the hospital's financial recovery, that's really helping.

And so they're continuing to have these conversations with us, and we're continuing to buy capital. And I think talking to our Spine division. The other day, they anticipate the Mazor sales to get back to normal levels here, so which is evidence of what I just said. And the second thing that's helping is we're working with a number of financing companies to provide various different financial -- flexible financial solutions for the hospitals.

So those 2 things have really helped us. And although that it's -- there is some pressure, it's not like maybe you might see with general imaging or something like that.

I'll ask Geoff to conclude with his remarks. Geoff?

Okay. And thanks, everybody, for the questions and the great engagement. And we really appreciate your support and the continued interest in our company.

We will -- we hope that you'll join us for our Q3 earnings broadcast, which we anticipate holding on February 23, where we'll update you on our continued quarterly progress.

So thanks for tuning in today. Stay healthy and safe. And for those in the U.S., I'd like to wish you and your families a very happy Thanksgiving. And have a great day, everybody.