Medtronic plc

Good morning and welcome to Medtronic's fiscal year 2022 second quarter earnings video webcast. I'm Ryan Weisbunning, vice president and head of Medtronic investor relations. Before we start the prepared remarks, I'll share a few details about today's webcast. Joining me are Jeff Martha, Medtronic chairman and chief executive officer, and Karen Parkhill, Medtronic chief financial officer. Jeff and Karen will provide comments on the results of our second quarter, which ended on October 29th, 2021, and our outlook for the remainder of the 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 .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 statements. Unless we say otherwise, all comparisons are on a -over-year basis, and revenue comparisons are made on an organic basis. Second quarter organic revenue comparisons adjust only for foreign currency, as there were no acquisitions or divestitures made in the last four quarters that had a significant impact on total company or individual segment quarterly revenue growth. References to sequential revenue changes compared to the first quarter of fiscal 22 and are made on an as-recorded basis, and all references to share gains or losses refer to revenue share in the third calendar quarter of 2021 compared to the third calendar quarter of 2020, unless otherwise stated. Reconciliations of all non-GAAP financial measures can be found in our earnings press release or on our website at .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. This morning we reported two two results, which despite a challenging market backdrop, reflects solid execution around new product launches and strong underlying earnings growth. Obviously, our end markets were impacted by the COVID-19 resurgence and the healthcare system staffing shortages, particularly in the U.S., which affected our quarterly revenue growth. Procedure volumes were lighter than expected in markets where our technology is used in more deferrable procedures like our spine business, or those that require ICU bed capacity like TAVR. Yet in markets where procedures are less deferrable, like pacing, we experienced stronger growth. While the U.S. market was a headwind, many of our international markets were much stronger. We delivered 6% revenue growth outside the U.S., including mid-teens growth in emerging markets. And our emerging market growth is up 9% versus pre-pandemic levels in Q2 fiscal 20. In the midst of these market headwinds, we focused on managing what was in our control and executed to advance our pipeline, launch new products, and win share. And when you look at our sequential revenue performance, our 2% decline was slightly better than most of our large-cap med tech competitors. While the pace of the recovery from pandemic headwinds is hard to predict, our markets will recover. And as that happens, Medtronic is one of the best positioned companies in healthcare. The underlying health of our business is strong, and it's getting stronger. We have an expansive pipeline of leading technology, a robust balance sheet, and an expanding roster of proven top talent. Coupled with our revitalized operating model and new competitive mindset, we remain poised to accelerate and sustain growth. As I've done in prior quarters, let's start with a look at our market share performance. -over-year market share is an important metric that our teams are evaluated against in their annual incentive plans, along with revenue growth, profit, and free cash flow. And right now, the majority of our businesses are winning share, driven by our innovation and increased competitiveness. And this is exactly the sort of market share performance that gives us confidence in the deep strength of our businesses. And to avoid any confusion about how we're performing, when we talk about our share dynamics, we'll refer to revenue share in the third calendar quarter to keep it directly comparable to our competition. Share momentum in our three largest businesses continued. In the cardiac rhythm management business, we extended category leadership, adding over point of share -over-year, driven by our differentiated micro family of pacemakers, cobalt and chrome high-powered devices, and our Tyrex antibacterial envelopes. In surgical innovations, we outperform competition with strong performances in endostaping and sutures. And our Cigna-powered stapling system and tri-staple technology continues to see great market adoption. In cranial and spinal technologies, we're winning share and launching new spine implants that enhance the overall value of our ecosystem of preoperative planning software, imaging, navigation and robotic systems, and powered surgical instruments, which is transforming care and spine surgery. Our new implants also go directly at the competition, starting this past quarter with our cataleptic expandable inner bodies to specifically attract Globus users. In addition to our three largest, a broad array of our other businesses have increased our competitiveness, our launching new products and winning share in their end markets. So for example, in patient monitoring, we're winning share with our Nelcor Pulsar Symmetry sensors and our monitors. In respiratory interventions, we picked up four points of share in premium ventilation due to our ability to respond quickly to spikes in demand from COVID resurgence. And in neuromodulation, we won share across our product lines, including pain stim and DBS, as we continue to launch new products. In pain stim, despite the sequential slowdown in the market, we're gaining share with our Intellis with DTM technology and our Vanta recharge free system. In DBS, we had a very strong quarter, winning over six points of share. We're executing on the launch of our Percept NeuroStimulator with BrainSense technology, paired with our Sensite directional lead. And we continue to be the only company with sensing capabilities. Since launching Sensite in the US earlier this fiscal year, we've surged ahead of the competition in new implant share. Sensing has redefined what it takes to compete in DBS. Our competitors don't have it. And as a result, we're expecting a long runway of share gains as we build upon our category leadership. Now, while the majority of our businesses are winning share, we do have a few businesses that are flat or losing share. And we're focusing our efforts and our investments to grow above the market. In cardiac diagnostics, we're focused on improving supply to reverse share to clients. And we're investing in new indications and novel AI detection algorithms to expand the market and drive growth. In cardiac ablation solutions, we expect to win shares as we expand the rollout of our time and temp RF ablation system and drive awareness and adoption of our Arctic Front Advanced Pro cryoablation as a first line treatment for paroxysmal AF. In diabetes, while we lost share again this quarter, we remain pleased with the momentum we're building outside the US, not only with the 780G insulin pumps, but also with the positive customer feedback we've heard on our extended infusion set and finger stick free guardian sensor for. And we expect our US results to turn around as we launch these new products. Next, let's turn to our product pipeline. I've already talked about the impact our strong flow of new products is having in the market. We've launched over 180 products in the US, Western Europe, Japan, and China in the last 12 months. At the same time, we continue to advance new technologies that are in development. We're heavily investing in this pipeline with a targeted R&D spend of over $2.7 billion this fiscal year, which is an increase of over 10%, the largest dollar increase in our history. We're expecting these investments to create new markets, disrupt existing ones, and accelerate the growth profile of Medtronic. Let's start with our simplicity renal denervation procedure for hypertension. While we weren't able to end our on-med study early, we remain confident in our program and our ability to serve the millions of patients who make up this multi-billion dollar opportunity. As a reminder, our previous three sham-controlled simplicity studies all reached statistical significance, including the pivotal off-med study. And the on-med study remains powered to detect a statistically significant and clinically relevant benefit at the final analysis. We expect that on-med follow-up will complete in the second half of next calendar year, and then we'll submit the PMA to the US FDA for approval. When we think about renal denervation, let's start with the patients, who have indicated that they want options like the simplicity blood pressure lowering procedure to treat their hypertension as confirmed by our patient preference study presented earlier this month at TCT. We believe demand will be high, and we continue to expect this to be a massive opportunity that we will lead. Another opportunity for Medtronic is surgical robotics, where we are entering the soft tissue robotics market as a second meaningful player. We achieved a major milestone when we received CE Mark for Hugo last month, and we also completed our first procedures with Hugo in our Asia-Pacific region at Apollo hospitals in India. The first surgeons to use Hugo in a clinical setting have told us they believe Hugo addresses the cost and utilization barriers that have held back the growth of robotic surgery. Look, demand is high, and we're building a long list of hospitals that want to join our Partners in Possibility program and be among the first in the world to use Hugo and participate in our global registry, which will collect clinical data to support regulatory submissions around the world. Our robotic program is making progress toward a broader launch, and we remain well positioned in this critical field relative to every other potential new entrant. As we prepare for this broader launch, we're working hard to ensure an outstanding customer experience. We're also focused on optimizing our supply chain, manufacturing, and logistics to prepare for scaling this business. We're making steady progress on these activities, but not at the pace that we'd originally planned. And as a result, sales this fiscal year are likely to come in below our $50 to $100 million target. Now that said, we still expect double-digit millions in sales this fiscal year, and we continue to expect a strong ramp in FY23. We're off schedule, but we're not off track. And while we're disappointed in the revenue pushout for this important program, we're confident that we have lined the site to the solutions we need to be successful and to optimize the customer experience. Demand remains high. Surgeons continue to do cases. Our order pipeline continues to build, and we're looking forward to starting our USIDE soon. We remain confident in the success of this program, and we believe that we're poised to meaningfully expand the soft tissue robotic market and drive growth for years to come. In cardiac rhythm, we just launched our microAV leadless pacemaker in Japan earlier this month. We also completed the US Pivotal Study enrollment for our EVICD, which follows our CE Marks submission in Q1. Just as we disrupted the pacing market with MICRA, we intend to do the same in the implantable defibrillator space with our EVICD. Our device can both pace and shock without any leads inside the heart and veins, and it does this in a single device that is the same size as a traditional ICD. In structural heart, we're starting the limited US launch of our next-gen TAVR system, the EVOLUTE FX, this month with a full market launch planned for fiscal Q4. EVOLUTE FX enhances ease of use with improvements in deliverability, implant visibility, and deployment stability. We're also making progress on our TransCatheter Mitral Program. At TCT earlier this month, we presented very encouraging early data of our transfemoral delivery system for our intrepid mitral valve, and we will be rolling that system into our Apollo Pivotal Trial. In diabetes, our MiniMed 780G insulin pump, combined with our Guardian 4 sensor, continue to be under active review with the FDA. When approved and launched in the US, we expect the 780G system to drive growth, as it will be highly differentiated and further address the burden of daily diabetes management, and for the first time ever is helping -to-manage pediatric and adolescent patients achieve outcomes mirroring well-controlled adults. The user experience has also improved markedly, and these outstanding results were achieved with our 780G paired with our Guardian 3 sensor, so we expect the experience will be even stronger with Guardian 4. And the value of our offering will be further enhanced when we bring our Synergy sensor, which is now called Simplera, to market. Simplera is disposable, it's easier to apply, and half the size of Guardian 4, and we expect it to be fully distributed and fully submitted to FDA later this fiscal year. In pelvic health, we're awaiting FDA approval for our next-gen InterStim Recharge Free device, which we expect in the first half of next calendar year. With its -in-class battery, constant current, and full-body MRI compatibility at both 1.5 and 3 Tesla, we expect this device will extend our category leadership in this space. In neuromodulation, we recently submitted our eCaps closed-loop spinal cord simulator to the FDA. We're calling this device InceptivSDS, and we expect it to revolutionize SDS with closed-loop therapy to optimize pain relief for patients. We also continue to make progress on expanding indications for SDS into non-surgical refractory back pain, painful diabetic neuropathy, and upper-limb and neck chronic pain. Finally, in DBS, we continue to enroll patients in our ADAPT-PD trial, studying our closed-loop adaptive DBS therapy in patients with Parkinson's. We're expecting enrollment in the trial to complete later this fiscal year. Now, before I turn it over to Karen, the one thing I most want to emphasize is that despite the ups and downs of the pandemic and its collateral impacts on hospital procedures, nursing and staffing shortages, and the supply chain, our underlying business remains strong. Medtronic is advancing a pipeline of meaningful innovation that we believe will not only enhance our competitiveness, but will accelerate our total company growth going forward. And with that, I'll turn it over to Karen to discuss our financial performance and our guidance. Karen?

Thank you, Jeff. Our second quarter organic revenue increased 2%, reflecting the market impact of COVID and health system staffing shortages on procedure volumes, primarily in the United States. Despite the softer end markets, our team executed to deliver strong margin improvement and earnings growth. In fact, our adjusted EPS increased 29%, significant growth reflecting the pandemic impact last year. And our adjusted EPS was 3 cents better than consensus, with 2 cents from stronger operating profit and a penny from a lower than expected tax rate. Our second quarter revenue growth came in lower than we were expecting back in August. We did see improving trends in our average daily sales each month of the quarter as COVID hospitalizations declined. That said, the bounce back in the U.S. wasn't as fast as we had expected or had seen in prior waves. We recognize many of our customers are dealing with staffing shortages on top of increased COVID patients, and we believe that had an increasing effect on procedure volume. Looking down our P&L, we had strong year over year improvement in our margins. 360 basis points on gross margin as we continue to recover from the significant impacts from COVID last year. And 470 basis points on operating margin, given savings from our simplification program tied to our operating model. Converting our earnings into strong free cash flow continues to be a priority. Our year to date free cash flow was $2.4 billion, up 58% from last year, and we continue to target a full year conversion of 80% or greater. Turning to capital allocation, we continue to allocate significant capital to organic R&D, and we continue to seek attractive tuck-in acquisitions to enhance our businesses. For example, Intersect ENT, we announced our intent to acquire back in August. Intersect's assets complement our own and are accretive to our Wham-Gurr. Plus, we believe we can accelerate their growth around the globe. We're also returning capital back to our shareholders, with a commitment to return greater than 50% of our free cash flow, primarily through our dividend. Year to date, we've paid $1.7 billion in dividends, and as a dividend aristocrat, our attractive and growing dividend is an important component of our total shareholder return. Looking ahead, although the environment remains fluid, we are seeing some improvement in procedures and our average daily sales in the first few weeks of November. So, we're encouraged that the negative impact of the pandemic and healthcare system staffing shortages on our markets could be moderating. And while our operations team has done a terrific job managing our supply chain to date, like other companies, we are dealing with an elevated risk of raw material supply shortages. As a result of these potential headwinds, and given we're only midway through our fiscal year, we believe it is prudent to update our fiscal 22 organic revenue growth guidance to 7 to 8% from the prior 9%. If recent exchange rates hold, foreign currency would have a positive impact on full year revenue of $0 to $50 million, down from the prior $100 to $200 million I gave last quarter. By segment, we expect neurosciences to now grow 9 to 10%, cardiovascular and medical surgical to grow 7.5 to 8.5%, and diabetes to be down low single digits, all on an organic basis. Despite the headwinds we face on revenue, we will manage well what we can control, which includes expenses not directly tied to our future growth. We will continue to invest heavily in R&D and market development, and on the bottom line we reiterate our non-GAAP diluted EPS guidance range of $565 to $575. This continues to include a currency benefit of $0.05 to $0.10 at recent rates. For the third quarter, we're expecting organic revenue growth of 3 to 4% year over year. This assumes no real pickup in organic comp-adjusted growth versus pre-pandemic levels from what we saw in the second quarter, despite the improving trends we saw in September and October. While we are encouraged by those trends, and by what we're seeing in November, we wanted to err on the side of caution with near-term guidance, given the dynamic macro environment. At recent rates, we're expecting a currency headwind on third quarter revenue of $80 to $120 million. By segment, we expect cardiovascular to grow 5 to 6%, neuroscience 4 to 5%, and diabetes to be down 2 to 3%, and medical surgical 2 to 3%, and diabetes to be down mid-single digits, all on an organic basis. We expect EPS between $1.37 and $1.39, with a currency tailwind of 2 to 4 cents at recent rates. While we expect our markets will continue to be affected by the pandemic in the back half of our fiscal year, we remain focused on delivering solid revenue growth, strong earnings growth, and investing in our pipeline to fuel our future. We also remain confident about the underlying strength and competitiveness of our business and our ability to accelerate revenue growth ahead. Finally, I'd like to take a moment to acknowledge our incredible employees around the world who have worked tirelessly to overcome the many challenges created by the pandemic, executing our operations and supply chain, helping our customers, and through it all, continuing to invent, develop, and deliver the healthcare technology of tomorrow. I also want to recognize a new member of our team, who many of you know. We couldn't be more excited to have Bob Hopkins, the top rated med tech analyst over the past three years, join our team as head of strategy. And we look forward to a strong contribution and influence in the years ahead. Back to you, Jeff. Okay, thank you,

Karen. And yes, it is great to have Bob here at Medtronic. For the last few quarters, I've been closing by commenting on the progress the company is making in various areas of ESG, our environmental, social, and governance impacts. Part of the S in ESG is our focus on inclusion, diversity, and equity, and high employee engagement, which I discussed last quarter. And this makes Medtronic an attractive destination for top talent. In the release we issued last week, you read about how Bob Hopkins and other highly sought-after world-class leaders chose to join Medtronic and drive our transformation to become the undisputed global leader in healthcare technology. It's very important for our culture that we're bringing in new ideas and diverse perspectives to add to those of our talented leadership and employees across the company. On the E front of ESG, as you know, we set an aggressive goal last year to be carbon neutral in our operations by the end of the decade. And two weeks ago, we upped our game, announcing our ambition to achieve net zero carbon emissions by FY45 across our value chain. This ambition outlined in our FY45 decarbonization roadmap will focus on operational carbon neutrality, supply chain greenhouse gas emissions reductions, and ongoing logistics improvements. To support our progress, as well as progress across our entire industry, we joined the International Leadership Committee for a net zero NHS in the UK. And we're taking a leadership role with the U.S. National Academy of Medicine Action Collaborative to decarbonize the U.S. healthcare sector. Our ESG efforts are gaining recognition, as last week Medtronic was elevated from being a constituent of the Dow Jones Sustainability North America Index to joining a select group of companies in the Dow Jones Sustainability World Index. Look, we are really proud of this achievement. In addition, I hope many of you were able to watch our inaugural ESG Investor Briefing last month. And if you haven't, I encourage that you watch the replay on our Investor Relations website. Now let me close on this note. The lingering effects of the pandemic, combined with healthcare system staffing shortages, impacted our Q2 revenue more than we originally anticipated. We have both puts and takes on the timing of our pipeline, and the supply chain dynamics pose near-term challenges. But our challenges will be manageable. We've got this. Our pipeline is delivering. And we're poised to deliver more innovation over the coming quarters and the next several years. We have to show you that we can deliver. But robotics is coming. RDN is coming. Closed-loop SCS is coming. And our diabetes turnaround is coming. And Evolut FX and Mitro and EVICD and the pending acquisition of Intersect D&T, these are all coming. We're ready to execute and capitalize on these opportunities. We're in good markets, and we're focused on innovating, winning share, and maintaining and or achieving true category leadership across our businesses. I know we have more to prove, but I'm confident that our organization, our talented and dedicated ,000-plus global employees, are up for the challenge. We're focused, we're hungry, and ultimately, we're going to deliver on these opportunities to accelerate our growth. And as always, we remain deeply committed to creating value for you, our shareholders. And with that, let's now move to Q&A. Now, we're going to try to get as many analysts as possible. So we ask that you limit yourself to just one question. And if you have additional questions, you can reach out to Ryan and the Investor Relations team after the call. With that, Wyn, can you please give the instructions for asking them questions?

For the sell-side analysts that would like to ask a question, please select the Participants button and click Raise Hand. If you're using the mobile app, press the More button and select Raise Hand. Your lines are currently on mute. When called upon, you'll receive a request to unmute your line, which you must respond to before asking your question. Lastly, please be advised that this Q&A session is being recorded. For today's session, Jeff, Karen, and Ryan 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'll pause for a few seconds to assemble the queue. The first question comes from the line of Robbie Marcus at JPMorgan. Go ahead, Robbie.

Great. Thanks for taking the question. Good morning, everyone. You know, I think everyone's happy to see the EPS guide reiterated here, but I think the top-line guide is a little bit surprising, particularly where you have third quarter organic sales guidance, given I believe you made the comment that November was trending better. So I was hoping you could talk through that and maybe just walk through the Hugo launch delay. What you're seeing there, is it an adoption issue, a technology issue, or is it purely difficulty getting into hospitals with COVID-19 going on?

Thanks. Hey, Robbie. Thanks for the questions. I'll let Karen answer the guide question and maybe I'll hit the robotics question.

Thanks, Robbie. And you know what? For the guide, I'm going to walk you through the quarters a bit to help give you and set the context. You know, and I'm going to start with Q2, because versus, if you look at versus pre-pandemic levels or two years ago, our growth in Q2 was about 1% organically. It was a little below peers, but you got to keep in mind that our inventory levels were lower back then, because that was before we made the change to bulk purchasing. So if you adjust for that inventory issue and a little bit of a tougher comp, our Q2 growth was in the 2 to 3% range versus pre-pandemic levels. And if you look at it sequentially, you know, our revenue from Q1 to Q2 declined less than 2%, and that was, you know, while most of our peers saw declines of 3 to 5%. So our performance in Q2, we believe, you know, is in line, you know, at least in line with what we're seeing from our peers. And then if you look at Q3 in our guidance, we're expecting that same 2 to 3% growth as we saw in Q2 versus the pre-pandemic levels. And yes, that equates to, you know, a slight deceleration from what we saw in October. And we're encouraged by what we've seen in October and into November. But given the dynamic environment, we focus on wanting to err on the side of caution with our Q3 guide. And then for Q4, you know, we're assuming normal sequential seasonality just because it's our fiscal year end. So you'll see sequential improvement in Q4. So hopefully that's helpful.

OK, so then maybe on the robotics question, I mean, let me first by saying, you know, no, it's definitely not a demand issue. The demand remains high, higher than we can fill at this point. And, you know, we're continuing with our regulatory filings around the world. We're going to begin the US IDE here very soon. You know, insurgents are continuing to do cases. You know, we're doing so far euro and dying cases and we're close to I think we're in any day now like our first general surgery case. So so like I said, demand continues to build. So the the issue that we're doing, this is more of a limited release phase. That's where we are right now. And we're focused on optimizing the user experience. And the issues that we're managing through are some supply chain issues and some initial manufacturing issues. And those are the those are the issues that we're working through right now. And we're really focused on, you know, making sure that these initial experiences with surgeons are really good. And so that's that's that's the reason, you know, for the slower revenue this year. But then again, next year, we expect next fiscal year a really strong ramp.

Thanks a lot.

Thanks, Robbie. Next question, please, when next

question comes from Vita Kumar at Evercore ISI.

Thanks for taking my question. Jeff, I had a two part product related question, one on microbe. There was an FDA layer earlier this month on complications related to perforations. How should we think about microbe? You know, is that is that something the street needs to worry about? And one on RDN, you expressed a lot of confidence in the outlook. We've had a couple of trials where some of your peers have missed eight points. Is your trial design different from your peer? Because when I look at your peer, you know, they added a four drug and that's when you saw the control arm improve, so if your trial design is similar to your peers, then you know, what is the confidence we have that your control trial will hit the primary end point a year from now? Thank you.

All right. Thanks, EJ. I'm going to turn this one over to Sean, but before I turn it over, because both the microbe and the RDN question fall into his world. You know, I'll give you my short answer on microbe. Don't worry about microbe. I know Michael is doing really well. I'll let Sean provide a little more commentary on the FDA letter. And then on RDN, you know, look, we're, Sean will give you more details, but we're very confident about this. We've got a lot of data here. We've had a registry going for a long time. We're following a lot of patients, picking up a lot of data here. And I'll remind you that our trial wasn't designed to end early. I know some expectations got ramped up about it ending early. And we're confident on this one. And the FDA has seen the patient preference data. They work with us on this and patients really want this. FDA knows that. And look, I've been out myself in the last couple of months talking with, and in the last couple of weeks especially, talking to a number of our investigators and this works. This works when patients like it. And the FDA knows that and we're confident in our trial. But I'll let Sean give you some more commentary on that. Sean, you want to chime in here? You got to unmute.

And, Vijay, thanks for the question. I think first on microbe, this FDA letter is more just a reiteration about the importance of being mindful of implant safety. But, you know, the actual rate of perforation that we've seen in the continued access study, the continued evidence development study, which we just reported out two-year results at the ESC, is actually below what we showed in the preclinical work and the preapproval trial. And the overall complication rates for leadless pacemaking are about 30% lower at two years than what we see with transvenous. So there's certainly no concern here. And the customer reception has been really, really excellent and continues to be spiked. The letter of the FDA just emphasized. And on the clinical trial front for Ardian, you know, you are right. There are differences in the clinical trials and we remain, as Jess said, very confident that our on-men's trial is going to make this end point. I think what you're referring to is the Regions study that was reported at the Regions TRIO study, which at six months they did a forward titration of drugs to get patients to their goal. So that was that, you know, part of their study design was, you know, after the primary endpoint of two months, they added drugs on it until blood pressure went down. And that's kind of the point of legal innovation in general is that you can get there without as many drugs. And we saw something similar in the pilot study for on-men's where we were able to forward titrate drugs after the primary endpoint and get people's blood pressure there without having to go to diuretics, which patients really hate taking. So, yeah, there's nothing to read through in that one. The trial they did in Japan and Korea was a little different. It was more like H-STAN 3 where they didn't control for medications. They had none of those types of controls. So that's more of a legacy study design that didn't leverage the learnings that we got from H-STAN 3.

Thank

you,

guys. Thanks, Vijay. Let's take the next question, please, Wynne.

The next question comes from Larry Bagelson at Wells Fargo. Go ahead, Larry.

Good morning. Thanks for taking the question. So one on diabetes, the quarter was in line, but you just found the guidance. You know, why is that? What are your expectations for the timing of 780G and Guardian 4? And Jeff, we've seen a wave of spins recently. What's your view of spins in general and do you see opportunities at Metronic for spinning off non-core or underperforming segments? Thanks, guys.

Thanks for the questions, Larry. I'll take the spin one and then I'll let Sean take the diabetes one. Look, as we've talked about in the past, you know, looking at our portfolio on capital allocation is a high priority. And this new operating model, the executive committee, you know, so my leadership, the leadership team here, we spent a lot more time on looking at our portfolio on capital allocation than we have in the last 10 years since I've been here, that's for sure. Orders of magnitude more time. And look, we're always looking at our different businesses, including our high-performance businesses and high-growth businesses, to make sure we're the right owner because I do think, you know, focus is important and making sure that you can provide the right amount of capital and other synergies between businesses that matter. And we're always looking at this and debating this. I mean, we've engaged our board as well, you know, quite a chunk of our time in each board meeting is spent on this as well. So I do see opportunities. I'm not signaling anything, but I can tell you that this is something that, you know, that we're constantly looking at. I don't see ourselves as like a GE or J&J that have like dramatically different businesses, but I do think it's an opportunity for us over time. Sean, you want to take the diabetes one?

Yeah, sorry, Jeff. My mute button was broken there. Yeah, so nothing different than what we've been talking about all along. We've got really strong uptake of 780G and Garden Force Dense outside the United States. In the U.S., we have just we're waiting for that approval to come through. And we've had very good interactive conversations with the FDA. I think we're making excellent progress there. But you remember that when we launch a new product in diabetes, there's a training element to that that takes some time so that it pushes the revenue outward before it starts to gain traction. What we see in the U.S. is while we're growing pump share right now, globally, we do have a lot of patients that came out of the install base and have to kind of rebuild that install base to get momentum going. And that's really going to be driven by the 780 with Garden Force sensor launch. Thanks, guys. Thank you, Larry. We'll take the next question, please, Lynn.

Next question comes from Matt Taylor at UBS. Go ahead, Matt.

Thanks for taking the question. I had two small follow ups, one on the overall environment. We were talking about these COVID-19 package for the genes. It sounds like you've seen things get a little bit better in November. And I was wondering if you had a hypothesis as to why that was. Could you give us more of a favor for how much improvement has been in this venture?

Sure. On the on the environmental side, yes, sir. So that like we said in the commentary each month throughout our quarter, throughout our Q2, you know, was better than the next. And we didn't quantify that. And it got better into November. But, you know, the the the procedures that the procedures have bounced back, but not as quickly as prior waves, you know, and nor as fast as we hoped. There's definitely it's definitely a fluid situation. And it's got a little bit harder, more difficult to predict. Right. It before was more of an epidemiology discussion around COVID cases and the severity of them and the impact to ICU beds. Now you've got this this critical staffing shortage in our in hospitals around the world. I mean, really, particularly more so in the U.S., though, particularly this this nursing shortage you hear about. And that's that's a little that's been a little bit more difficult to predict. And I think that's the thing that I'd say surprises a bit last quarter. And then finally, you've got some supply chain issues, which for us have been manageable so far. But as time goes on, that gets more difficult. So, you know, we we took I think a parent walk through the guidance, we took a conservative approach here, particularly for a two, three guide on that. But it's difficult to quantify all these things working together here. The the COVID cases jumping back up, like you've read about in Europe, nursing shortages in the U.S. And then global supply chain issues. I think the hospitals are doing a good job managing the headwinds they have. And I think we've done a pretty good job. Our team's done a really good job on the supply chain issues. You know, during COVID, we were able to build up inventory on some of these critical products. But as these issues drag on, it becomes more challenging. And that's why we've taken a I think a bit of a, you know, appropriate position given the uncertainty for our two, three guide. Sorry.

Thanks for that, Jeff. Maybe I could just ask a follow up supply chain. We talked about some of the issues with Hugo and the impact on this year's revenue. Do you have any thoughts on how quickly that can resolve and what kind of contributions we should expect in the subsequent years versus the prior guidance that you have given?

Right. Well, so look, first of all, I'd say, you know, I should have mentioned this when I was answering Robbie's question. You know, we did underestimate, you know, the supply chain, some of the supply chain issues and early manufacturer issues in a complex program like that. Like this. This is a complex program. That's on us. We should have probably provided a little bit more cushion there because we really, like we said all along, want to make sure that we're optimizing the customer experience here. So in terms of how long this goes on, it will in terms of like, first of all, like we said, we're still having double digit revenue this year, double digit millions. And we didn't quantifying Q the next year, but I'll tell you this, it will be a very healthy, healthy ramp off this year. So like I said before, because we are cases are continuing, demand is building. We're continuing to get new regulatory filings that we filed for and expect approvals and starting our U.S. IDE soon. So there's a lot of activity going on here, a lot of good things, a lot of good feedback. And, you know, we just we just appropriately are optimizing, in my opinion, the end user, the customer experience here. And, you know, FY23 will be a strong year for the robot. Thanks for taking the question. Thanks, Matt. I will take the next question, please, Wayne. The

next question comes from Cecilia Farlong at Morgan Stanley.

Good morning and thank you for taking the question. I wanted to ask just on Hugo as well, RDN, the expenses you talked about previously, the 400 million this year, just how we should think about realizing that this year versus what gets pushed into next year. And combined with that, just how we should think about expense ramp and 23 fiscal 23 associated with your other pipeline products. Thank you.

Yeah, thanks, Cecilia. I'm happy to take that. So the the 400 million dollar operating profit drag that we talked about earlier this year was not just Hugo. It was both Hugo and RDN and the important investments we're making in those big product launches for us. And so we will continue to have, you know, more expense on on those products in FY23. It is it is too early to, you know, give you a signal because we still have two quarters to go this fiscal year. And we're just beginning our planning process for next fiscal year.

Thank you, Cecilia. Next question,

please. The next question comes from Matt Makesake at Credit Police. Go ahead, Matt.

Thanks so much. We can. Thanks, Matt. So lots of things we could sort of ask after. But if I just to take one question, I maybe come back to the to the staffing question. And it sounds like you have been taking a stab at the fiscal third quarter, which is obviously important calendar quarter for everyone in the devices given kind of the traditional Q4 push. And I just wanted to maybe ask you to talk a little bit about your confidence that we sort of see a turn after that. Is this a Q3 impact with some improvement into Q4? And then maybe what what? And I apologize because I know it's a terribly uncertain topic. But but just what kinds of things would give you confidence that that we do get past the staffing things as we get through the spring and into into mid year next year?

Well, well, first on thanks for the question, Matt. I mean, obviously, the staffing issues is a hot topic. And I just spent a lot of time with our team on this as well as our hospital customers. You look at these hospitals are basically investing more in staffing. I mean, that is, I think one of the biggest issues here is is is them are the biggest opportunities. They're just they're paying more money for for the staffing to get to and send people to come back. And the other thing that I see hospitals doing where we're spending a lot of time with them is adoption on more remote capabilities and business models. I mean, in our world, things like managing your cardiac rhythm patients using remote technologies, they don't have to come back into the to the hospital and get the device checks. We're doing that. We're doing that remotely. And I can go down the list of other other of our therapies like another one would be, you know, it's not in the US yet, but in the NHS in the UK, they're using our pill cam. They've accelerated the use of the rollout of pill cam to do colonoscopy, diagnostic colonoscopies for their patients because they've built up a long waiting list of people who are getting colonoscopies. So I see hospitals, you know, one, it's not a sustainable situation, but short term, you know, providing bonuses and incentives and two, much more rapidly adopting some of in our case. I mean, and they're working with other other industry players as well to adopt things that are more remote and they're prioritizing therapies that have less complications that result in less hospitalizations and and return hospitalizations. So, I mean, it's it's it's not an overnight solution, but they're aggressively working this. I mean, no one likes to cancel a TAVR case because there's nobody to monitor the ICU bed or cover the gas. So nobody wants to do that. And so they're moving fast on this. And and like I said, we're seeing, you know, we're seeing progress here, even in our results in the November. But it is it is fluid. And that's why we've taken the approach we've taken on the guy. I don't feel anything to add care into that. No, she's saying no. So so I don't have more for you, Matt. This one's a tough one.

Well, thanks for calling.

Thank you, Matt. Take the next question, please.

When the next question comes from Joe and when a city. Go ahead, Joe. Thank you for taking the question.

And good morning. A couple of things I'm curious about. Do you think that there's been a change in the way that consumers are looking at health care?

Well, you know, I'm not sure if there's a question underneath the question, but yeah, I think consumers have been much more engaged in health care. And this is something that's weighing into to our strategy. You saw that, you know, we rebranded Medtronic here last quarter and, you know, gone to a different look in engineering. That's part of a first step to us more aggressively, directly reaching out to consumers and educating them about our therapies. I mean, things like, you know, pill cam genius, which I just talked about, things like cryo blation as a first line indication for a fit. You know, they don't want to be on these regimen of drugs. And so we historically have have have relied on our specialist physician partners, like in the case of cryo blation, AFib. It's been electrophysiologists to quote unquote build up our referral pathways in our markets. Now, I think given, you know, the changes in technology, the miniaturization, which leads to less invasiveness, the connectivity of our devices, the, you know, the better efficacy. We're we're moving up in the line in the food chain here, you know, closer to first line, like I mentioned in AFib. And some of our our businesses are already there, more of a consumer business like diabetes and our public health for overactive bladder. So you're going to see us more engaging consumers and directly. And we're in the reason we're bullish on this is one, like I said, the therapies have changed, less invasive, more efficacious. You know, in some cases, it's a better solution, clinically proven than than than than than pharma, which is the typical first line indication. The other thing that we're seeing getting to your question is, like I said, here's a proof point on consumers more engaging. Like on our Ardian trial, we that this trial filled up really quickly, enrolled really quickly, all through consumers opting in through our digital marketing efforts. In social media efforts in the Ardian trial, consumers self enrolled. That's a first for us. And so we are seeing much more engagement from consumers in their care and through, you know, they're using the Internet and digital platforms to to get that education. And that's changing our strategy.

Thank you very much.

Thank

you, Joanne. We'll

take the next question, please. The

next question comes from Matt O'Brien at Piper's Anva.

Thanks for taking the question. Is that looking across the the different segments on the surgical side, the one that's gone the most from the first guidance that you provided last quarter is the cardiovascular business. And I get the whole staffing shortage issue. It's just a little surprising, you know, TAVR, you can't delay those too long. So I'm just wondering how long that some of these pressures you think will last. I mean, is this something that's going to go deep into calendar 22 that you're going to continue to encounter in that segment? And then, you know, what what can really kind of what can you do to help us weigh some of these issues on the staffing side? Thank you.

Well, you know, look, it's it's like I said, it's hard to predict, Matt, the timing. But like I was just with a one of our bigger customers in the in the in the south of the United States a week and a half ago. And and they had a couple of it was a, you know, you know, cardiologists that had a couple of TAVR cases canceled that day. And there's a huge sense of urgency because of the the nursing shortage. So they have a huge sense of urgency in correcting that issue. And like I said, they are, you know, prioritizing moving nurses. First of all, they're they're getting more aggressive with their staffing strategies to attract and retain staff. They're they're reallocating resources around the the the hospital, the health system, if you will, to get more nurses into these critical care areas. They're pushing certain cases out to ASCs. We're seeing growth in surgical centers where they need less staff to do these cases. So we're seeing that we're seeing them aggressive aggressively make these I'll call it reallocations of resources. And we're helping them as much as we can in these areas. So I look these like you said, you can't defer these cases. First of all, I don't know how I don't like that. Never like the term elective. I think it's more deferrable and you can only defer some of these cases so long as you pointed out. And so, you know, people are innovating. Hospital systems are innovating here. And I just don't know. It's really hard to predict. I mean, like I said last quarter, we, you know, we underestimated the the impact of the nursing shortage. Like you said, we're seeing improvement, but and we've taken a conservative guide in our fiscal Q3 in particular. But it's it's really difficult for us to to provide, you know, much more specifics than that.

Matt, I might add, I know you're all trying to figure out how long this will last. And, you know, if you just look at if we just look at the recent trends in November, we saw, you know, some good upticks last month, particularly in cardio. Now, we don't know if that's because it's pre-holiday, pre-Thanksgiving, you know, but we are seeing some good encouraging trends.

Thanks. Thank you, Matt. Take the next question,

Wyn.

Next question comes from Chris Pasquale at Guggenheim. Go ahead, Chris.

Thanks. Karen and Jeff, most of the focus in terms of macro headwinds has been on the U.S. so far that some of the recent headlines in Europe have been a bit concerning. Just curious what you're seeing in a European business over the past few weeks and whether guidance assumes any deceleration in OUS procedure trends during the third quarter.

Well, Chris, thanks for the question. And you're right. The Q2 was a U.S. story for us. I mean, the other regions performed well, especially our emerging markets. You know, we're seeing, you know, really strong growth in emerging markets, but Europe performed well as well in other developed markets last quarter. Now, in the last few days and weeks, you're hearing in Europe about certain countries pulling back on elective cases. I really don't see this to be long lived here, given the vaccination status in these countries, you know, the high vaccination rates in most of these countries and other new therapies like the, you know, the oral antiviral therapies coming online. So I don't see it, you know, taking too long there, you know, directly from COVID. And, you know, we've reflected that in our guidance.

Thanks. Okay. We'll take the next question, please, Wayne.

The final question comes from Rick Wise at Staple.

Good morning, everybody. Maybe, Jeff, just since I'm bringing up the rear here, one bigger picture question from you, and then I'll add a question for Sharon. I mean, you're obviously working hard to, not exactly turn around Medtronic, but make Medtronic grow faster, be more profitable, be more innovative, execute better. I'm so curious your reflections on sort of a big picture sense of, do you feel that the challenges of COVID and staffing and everything you're talking about today has followed your personal mission to drive that forward? Obviously, you're highlighting innovation and all the new products, etc. But in a high level of just wondering your evolving thoughts, and maybe shorter, Karen, if you could just talk us through a little more gross margin. I mean, geez, gross margins despite the challenges of the quarter better expected. Maybe give us a little more color on that kind of trend in the second half. And do you feel more optimistic about the longer term potential to expand gross margins as all these new innovations roll out? Thank you

so much. Rick, well, thanks for the question. And maybe last, but definitely not least here. I appreciate the question. And look, it's a great question. And I'm very bullish on where we stand. And I'll walk you through why. I mean, yeah, COVID and this nursing, you know, this critical staffing shortage, or it's highlighted by this nursing shortage in the U.S. And just spending a lot of time talking about vaccines and vaccine mandates. Yeah, it is a bit of a distraction. But I, you know, I am very happy about our bigger picture here. We've won what I really like is is to structurally how we've made the company smaller on the front end, if you will, with these 20 operating units and the clarity that we have into the end markets and the dynamics, what the customers are really asking for, what the competitors are doing. And we've got a really good handle on our pipeline by each of these operating units. And we have gotten more aggressive in funding these businesses and holding them accountable to making the right choices and prioritizing innovation and innovating faster. So, you know, I feel really good about that. And my team, we spend a lot of time, you know, looking at these operating units and making these judgment calls. What is the appropriate funding? What does a good pipeline look like? How should we feel about the competition? And it's not just like me sitting around talking to an operating unit leader. It's my team, the different portfolio leaders, even if the business is not in their portfolio, asking tough questions, because every incremental dollar funding we put in, one business is one less dollar we put in another business. So the rigor around this and the constructive debate and the diversity of thought coming from the different people, it's leading to better decisions. And the energy around inside the company and around the company is palpable. I mean, we're getting, you know, we're getting, you know, our employee scores remain high despite all the burnout and everything. And he's infecting employees, affecting employees, but still we got great scores and feedback. You know, we're getting attracting talent like never before. We've had a 50 percent spike in our and people applying for jobs at Medtronic. You know, the market share situation is going well. And so, you know, look, we've got a lot to do here. We've got some big drivers that we've got to show. We've got to bring this robot program and ramp this already and we've got to get that data back and ramp that. You know, we've got the diabetes turn around. We're seeing we can see it. You can just see it off in the horizon. You can see the products doing so well in Europe and other parts of the world. We've got to get that in the United States. But, you know, we're making this progress. And that's why that's why I feel good. And culturally, you know, you're seeing a level of competitiveness and accountability. So like this quarter, you know, revenue didn't come in where we want it. We wanted but we still had an operational beat on EPS and we're holding EPS guidance for the rest of year. That's the kind of company that we want to be disappointed about the miss on revenue. There's some environmental factors. But quite honestly, I was hoping that we could overcome all of those. We weren't quite able to this quarter. But just to get some color commentary on how we think about it, that's how we're thinking about it. And we're going to I know we're doing the right things. We're going to stay the course. We're going to keep making these investments, keep holding ourselves accountable to being like the undisputed technology leader and growing above the market. That's where we want to go. And so optimistic about where we're going in that direction. So with that, gross margin, gross margin. Yeah.

And I just want to emphasize something that Jeff said before I go to gross margin, Rick. And that is, you know, despite the challenges that we've had from COVID, our R&D investment is not coming down. And we said at the beginning of the year, we were increasing that 10 percent and we still fully intend to do that. So we're offsetting our headwind in a different way when it comes to delivering the bottom line. Also on gross margin, you know, yes, our gross margin was better than expected. We're really pleased with that. We're we've got a very concerted effort to improve our operations and to lead to better gross margin. We're focused on getting our gross margin back to pre-COVID levels. And from there, at least sustaining it and hopefully improving it. And if you look at just the year over year, we're still focused on that two and a half to three points of improvement in gross margin this fiscal year. You know, when I think about longer term, I would just say to you that nothing has changed from our focus on delivering that five percent plus revenue growth and that eight percent plus bottom line growth. And I would say that includes next fiscal year in FY23, you know, even given some of these headwinds that we've talked about today.

Thank you, Rick. Jeff, please go ahead with your closing remarks.

OK, well, thanks, everybody, for the questions. We definitely appreciate your support and your ongoing interest in Metronic. And we hope that you'll join us for our Q3 earnings webcast, which we anticipate will be on. We'll be holding this on February 22nd, where we'll update you on our progress. And Ryan will kick off that call standing outside of our world headquarters here in Minneapolis again without a coat on. He's promised us that no matter what the weather. So with that, thanks for watching today. Please stay healthy and safe over the holiday. And, you know, and for those of you in the U.S., I'd like to wish you and your families a very happy Thanksgiving.