Abbott Laboratories

NYSE:ABT

Earnings Call Transcript 2021-Q3

[Operator]

Good morning and thank you for standing by. Welcome to Abbott 's Third Quarter 2021 Earnings Conference Call. All participants will be able to listen-only until the question-and-answer portion of this call. During the question-and-answer session, you will be able to ask your question by pressing the star one on your touch tone phone. Should you become disconnected throughout this conference call, please redial the number provided to you and reference to Abbott Earnings Call. This call is being recorded by Abbott.

With the exception of any participant's questions asked during the question-and-answer session, the entire call, including the question-and-answer session, is material copyrighted by Abbott. They cannot be recorded or rebroadcast without Abbott's expressed written permission. I would now like to introduce Mr. Scott Leinenweber, Vice President, Investor Relations, Licensing, and Acquisition.

[Scott Leinenweber, Vice President]

Good morning and thank you for joining us. With me today are Robert Ford, President and Chief Executive Officer, and Bob Funck, Executive Vice President Finance and Chief Financial Officer. Robert and Bob will provide opening remarks. Following their comments, we'll take your questions. Before we get started, some statements made today may be forward-looking for purposes of the Private Securities Litigation Reform Act of 1995, including expected financial results for 2021.

Abbott cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Economic, competitive, governmental, technological, and other factors that may affect Abbott's operations are discussed in Item 1A Risk Factors to our Annual Report on Form 10-K for the year ended December 31, 2020.

Abbott undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. On today's conference call, as in the past, non-GAAP financial measures will be used to help investors understand Abbott's ongoing business performance.

These non-GAAP financial measures are reconciled with the comparable GAAP financial measures in our earnings news release, and regulatory filings from today which are available on our website at abbott.com. Unless otherwise noted, our commentary on sales growth refers to organic sales growth, which excludes the impact of foreign exchange. With that, I will now turn the call over to Robert.

[Robert Ford, CEO]

Thanks, Scott. Good morning, everyone. And thanks for joining us. Today, we reported results of another very strong quarter. Ongoing earnings per share were $1.40, reflecting nearly 45% growth compared to last year, and sales increased more than 22% on an organic basis. Excluded COVID testing - related sales, which totaled $1.9 billion in the quarter, organic sales increased 12% versus last year. As we've seen since the start of the pandemic, our diversified mix of healthcare businesses continues to prove highly resilient.

Even as COVID case rates surged in the U.S. and other geographies during the third quarter, strong growth in our more consumer-facing businesses, nutritionals, established pharmaceuticals, and diabetes care mitigated the modest impacts we saw from the surges in certain areas of our hospital-based businesses. This has been a consistent theme throughout the pandemic, as evidenced by an increase in total Company sales, excluding COVID tests, of 11% on an organic basis through the first 9 months of this year compared to our 2019 pre -pandemic baseline, which highlights that our growth is real, and not simply a function of easy comps versus last year.

As a result of our strong performance and outlook, today, we increased our full-year adjusted earnings per share guidance range now at $5 to $5.10, which reflects nearly, 40% growth compared to last year. I'll now summarize our Third Quarter results before turning the call over to Bob. And I will start with nutrition, where sales increased 9% compared to last year. Strong growth in the quarter was led by U.S. pediatric and international adult nutrition. In pediatric nutrition, sales grew over 8.5% in the quarter, led by strong growth in the U.S. from continued share gains in our infant formula and toddler portfolio.

Sales of Pedialyte, our market-leading rehydration brand, once again grew strong double-digits driven by market uptake of several recently launched new products, as well as investments we're making in direct consumer promotion. In adult nutrition, sales grew over 9% in the quarter, including mid-teens growth internationally as we continue to see strong demand for our Ensure and Glucerna brands, including new users entering these categories and existing customers, increasing their usage. Turning to diagnostics, sales increased more than 45% overall, and 12.5% excluding COVID testing related sales. During the quarter as the Delta variance spread and COVID cases surged, particularly in the U.S., demand for testing increased significantly. Most notably for rapid tests.

In total, during the quarter, we sold more than 225 million COVID test globally and have now shipped over a billion tests since the start of the pandemic. Over the last several months, we've learned that COVID vaccines, while a powerful tool, are not the lone solution needed in our global fight against this virus. Testing, particularly rapid testing, which is fast, affordable, and easy-to-use, is an important companion to vaccines and therapeutics, Abbott has established a global leadership position in rapid testing, including supply capacity of more than 100 million tests per month.

Moving to established pharmaceuticals, where sales grew more than 15% driven by strong execution and a steady cadence of new product introductions. Strong sales performance in the quarter was broad-based across several countries, including double-digit growth in China, Russia, and India, which led to overall sales growth of 18% in our key emerging markets.

And lastly, I'll cover medical devices, where sales grew 13% in the quarter compared to last year, and more than 16% compared to pre -pandemic sales in the third quarter of 2019. Strong performance in the quarter was led by double-digit growth in rhythm management, structural heart, heart failure, and diabetes Care. In Structural Heart, we continue to enhance our portfolio in large, fast-growing markets, with the recent U.S. FDA approvals of Anulette which closes the left atrial appendage in the heart to help reduce the risk of stroke in people with atrial fibrillation, and Portico, for transcatheter aortic valve replacement.

In heart failure, we announced results from the guide HF trial of our CardioMEMS system. As with many other recent and ongoing clinical trials across the healthcare industry, a portion of the CardioMEMS trial, overlapped with the COVID-19 pandemic. After adjusting for this impact, CardioMEMS demonstrated a 28% reduction in heart failure hospitalizations. And we filed with the U.S. FDA for label expansion based on the trial data in the middle of this year.

During the quarter, we also added an attractive growth platform to our Vascular device portfolio with the acquisition of Walk Vascular, a commercial stage Company with a minimally invasive thrombectomy system, called JETi, that removes peripheral blood clots. Peripheral thrombectomy is a large high-growth area where we can leverage our existing commercial presence. And I'll wrap up with diabetes care, where strong growth was led by Freestyle Libre sales of nearly $1 billion. During the quarter, we added over 200,000 new users, bringing the total global user base for Libre to well over 3.5 million users.

So in summary, we continue to achieve strong, well-balanced growth across all of our major businesses, which is being fueled by strong execution and a steady cadence of new products. COVID testing -- particularly COVID testing, remains an important companion to vaccines and therapeutics, an Abbott has established a strong leadership position in this area. And based on the strength of our performance and outlook we're raising our EPS guidance for the year, which now reflects growth of nearly 40% compared to last year. I will now turn over the call to Bob to discuss our results and outlook for the year in more detail, Bob.

[Bob Funck, Executive Vice President]

Thanks Robert. As Scott mentioned earlier, please note that all reference is to sales growth rates, unless otherwise noted, are on an organic basis, which is consistent with our previous guidance. Turning to our results, sales for the third quarter increased 22.4% on an organic basis, which was led by strong performance across all of our businesses. Along with global COVID testing - related sales of $1.9 billion in the quarter. Excluding COVID testing - related sales, organic sales growth was 12.1% versus last year and 11.7% compared to the third quarter of 2019. Foreign exchange had a favorable year-over-year impact of 1% on third quarter sales, resulting in total reported sales growth of 23.4% in the quarter. Regarding other aspects of the P&L for the quarter, the adjusted gross margin ratio was 58.8% of sales, adjusted R&D investment was 6% of sales, and adjusted SG&A expense was 25% of sales.

Our third-quarter adjusted tax rate was 15.5%, which reflects an adjustment to align our year-to-date tax rate with our revised full-year effective tax rate forecast of 15%. The revised full-year forecast is modestly higher than the estimate we provided in July, due to a shift in the mix of our business and geographic income. Turning to the outlook for the fourth quarter, we forecast $1 to $1.4 billion of COVID testing - related sales and forecast organic sales growth excluding COVID testing - related sales in the low double-digits versus last year. And based on current rates, we would expect exchange to have an unfavorable impact of around 1.5 of 1% on our fourth quarter reported sales. With that, we'll now open the call for questions.

[Operator]

[Operator Instructions] Our first question comes from Robbie Marcus from JPMorgan. Your line is open.

[Robbie Marcus, JPMorgan]

Great, and congrats on a really nice quarter.

[Robert Ford, CEO]

Thanks.

[Robbie Marcus, JPMorgan]

So maybe after such a good quarter led by COVID testing, I feel like you have a unique perspective, looking at both sides of the coin from COVID testing, volumes and also device procedure volumes. So Robert, I'd love to get your sense of where you think we are here in fourth quarter, and heading into 2022, and any early thoughts you could give us on how to think about progression of COVID testing sales, and the recovery and durability of med-tech volumes.

[Robert Ford, CEO]

Sure. I think regarding COVID testing, we've obviously -- since the start here, the pandemic, we've been learning a lot. And I think one of the things that as we've developed our strategy for that, we always believe that the rapid test was going to be a kind of more sustainable part of the business, and I think we're pretty right there. I'd say the key thing that I -- and I made this in the comments -- in the opening comments are the key thing that we learned over the last let's say a couple of months here, is that the vaccine is just an incredible tool for the virus. It had a huge impact on public health around the world.

But it's -- but alone, it's not enough. We know that it dramatically reduces hospitalizations, dramatically reduces mortality, but I think we're all seeing here that even if you're vaccinated, you could still -- you could still get and you could still transmit the virus. Obviously, you're not heading to a hospital, but I think we've all heard and seen stories of that. So I think that's -- the biggest learning here for us as we go into Q4 and as we go into next year is that testing is going to remain an important companion here, and even with therapeutics it's still going to remain an important part of fighting the virus.

And I think we've also learned a lot about understanding the difference between symptomatic testing and screening testing. We started to pay much closer attention to understanding the channels and the platforms that are more aligned to symptomatic testing versus screening testing. And we can definitely see a correlation on the symptomatic testing with cases -- cases going up, cases going down. What we don't see that correlation is on screening. So even as cases are starting to come down a little bit in the U.S. Actually screening demand has increased quite a bit. So I think that is another key learning as we think about going into Q4 and thinking about going into next year also.

The other, I'd say, key distinction we've started to make is understanding government purchasing a test versus private. And I'd say in the beginning of the pandemic, most of our sales were focused to governments, whether international governments, federal government here in the U.S., state governments also. And that continues to be pretty strong. But what we've seen now grew pretty significantly, and I think it's aligned to the screening pieces, the private side of the market, whether it's OTC, cash pay, whether it's a lot of companies. We've seen a lot of companies, in the last couple of months here, signed contracts with us to ensure that they've got rapid testing to be able to give to their employees.

So while we're not seeing -- you always see some shelf and stocking issues at the retail, and those will work will work their way through that in the next couple of weeks. We are seeing, still, a lot of companies buy test s to get to their employees. So I think all of this is basically saying, listen, I don't know how much is going to be there next year, but it's clearly here that that screening segment of the market is going to be an important part even with therapeutics and vaccines. So I think that's going to be an important part.

Our base business has done very well, continues to be on a recovery trajectory here Robbie. Started in Q2, we saw that in devices, we saw that in diagnostics. Yeah, there was some softness during Q3 as Delta cases increased here in the U.S. That's probably more in August and throughout half of September, we started to see it re-pick backup again towards the end of the quarter, and the first couple of weeks. We like what we're seeing here in terms of -- in terms of some pickup. But these were pockets. I wouldn't call it like a general softness and slowed down. There are pockets here in the U.S., some pockets in some countries. But generally speaking, that base business is doing very well.

So when you think about 2022, I expect our base business, our underlying base business to continue that momentum, very strong momentum across-the-board, especially with all of our new product launches. And the question here is going to be COVID. And I think it's going to be very difficult as we go into next year to be able to forecast a full number -- a full-year number of COVID next year. I think we'll probably -- we're probably thinking about, "Well, there's probably a COVID number that we're comfortable going into 2022, " and then we'll have to update on a rolling quarterly basis here how COVID is going to play out through the -- throughout the -- throughout next year. So that's how I see it.

COVID is going to -- COVID testing will be there, we'll have to do it more on a rolling basis as we go to next year. And our base business continues to accelerate. There's a little bit of softness in Q3, but I like what we're seeing in terms of recovery, and I like the portfolio that we've built around our cardio business, our EPD business, our nutrition business, our diagnostic business. So that's all -- that's all good.

[Robbie Marcus, JPMorgan]

Great, great. That was really helpful. And then maybe Robert, to build on that, I know it's still very early in your planning process. But as you just said, there is a lot of variables, a lot of moving pieces, you've had a great year in devices so far, a bumper year in testing. Any early thoughts on how investors should be thinking about 2022, versus 2021 from a top and bottom line perspective? Thanks.

[Robert Ford, CEO]

Yes. Like I said, we're still in our process. We'll give our guidance in 2022 in January, like we always do, Robbie and I want to see a little bit more in terms of how this pandemic is unfolding here, especially on the COVID side, but on the base business -- I think our base business, I would say we've been pretty good at forecasting our business, both from a top - line, from a margin on our base business. So I think what you can expect in 2022 is that base business getting even stronger with the rollout of all these product launches that we've announced over this year. And then the question here, really, is going to be COVID testing.

And like I said, we'll have a portion of it that I think we'll feel good about putting it in. And then we'll have to be updating on a rolling basis. And I think that's how to think about it. The base business, which is probably the more sustainable piece is building momentum and it will go into 2022 with a lot of -- lot of growth opportunity. And then we'll have to look at COVID on a more rolling basis.

[Robbie Marcus, JPMorgan]

Great, thanks a lot.

[Operator]

Thank you. Our next question comes from Bob Hopkins from Bank of America. Your line is open.

[Bob Hopkins, Bank of America]

Well, thank you very much. And good morning and congrats on such solid execution. I just have two questions, and in the interest of time I'll just mention them both upfront, because the first one is pretty straightforward. The first question is just on Amulet and I realize it's very early in the launch, but just would love your sort of top-down comments on how things are going and maybe any metrics you can share in terms of perhaps like the percentage of your U.S. coronary accounts that are now active with Amulet.

So we'd love some just color there. And then the second question is more of a broad-based question. I was just wondering if you could provide just a little bit more detail on what you're seeing on inflation and supply chain. Because the headlines are obviously -- they're just constant. But the message from Abbott and So, other companies we follow just seems to be generally manageable. So just wondering if you can talk to that a little bit, if you can quantify the headwinds or just give us a better understanding of why it's manageable and just some put some perspective around it for us. Thank you.

[Robert Ford, CEO]

Okay. Well, I will take the Amulet and then I'll let Bob talk to the inflation supply chain. I mean, I would say it is manageable, but that we had a great team, and I'll let Bob cover that. On Amulet, listen, we received approval in August. We already initiated the launch. I know there's a lot of anticipation, at least on the last 2 calls, about the data, and when we're going to publish the data, and why we were going to do it. The time that we were going to do it. And so we released that data really close to our approval. I think that was a good strategy because it allowed our team to prepare for that. I will say, regarding the data, you saw when we release the data, the product's got a lot of advantages versus the product that's on the market right now, we've got a pretty broad portfolio sizes, and that helps as you are looking at different anatomies and having a better fit.

There's a Steerable Sheath that we've got, has resulted in great precision in the placement and that's super-important, especially when you're looking at Transcatheter Therapies. And then, you saw the data of superior kind of closure rates without the need for blood thinners right -- fallen right after procedure. And ultimately that's why the patient went to the hospital or part of the reason why they went there. So I think we've got a great product here. I think the team has done a good job getting the contracts ready.

Right now, I would say we have a goal of certain amount of contracts by the end of this year. And in the first month, we've already gotten 40% of them -- of that target. So I think that we're going to definitely hit what we need to hit in terms of getting our contracts, our accounts, the ones that we want to get on contract up and running so we could start to build the usage, and familiarity with the system. We've got a really strong commercial presence here, and I think that's a key aspect in the roll-out.

The implanters of these devices, the electrophysiologist s or the interventional cardiologists. We've got a lot of great products and a lot of great call points, so that's worked out very well, too. There's always a certain amount of coordination that's required there, and that coordination has been fantastic. I'm really pleased to see that. Initial feedback has been super positive. So very happy with the initial signs, like you said, it's about a month, month-and-a-half into it.

All of the signs that I'm seeing show that we'll have a great opportunity here to establish Amulet as another product in the category. And then on top of that, we're making the investments, like I said, to grow the category with all of our clinical trials. Catalyst is one of them, and that's because it's important also, so I'd say first month and half very, very pleased with what I'm seeing.

[Bob Funck, Executive Vice President]

Thanks. I will take the inflation comments. I think inflation and supply chain are really linked together. The global supply chain have not been able to keep up with strong demand out there. And so like others, we're seeing some increased input costs across areas of our business. We're experiencing some higher shipping costs. And in some cases, higher commodity costs. I'd say the commodity costs are really more in the nutrition area of the business. In some areas, we have flexibility to adjust pricing a bit and we plan to do that. In other areas, that flexibility doesn't exist.

And so we're working to mitigate the impacts we're seeing, essentially looking at other manufacturing costs. As Robert mentioned, we've got a very strong procurement organization and supply chain organizations, and they're doing a great job working with our suppliers. And our suppliers understand the critical nature of our products. And so it's been -- we've been successful in terms of ensuring that we're able to get what we need and to support the business.

[Bob Hopkins, Bank of America]

Thank you.

[Operator]

Thank you. Our next question comes from Josh Jennings, from Cowen. Your line is open.

[Josh Jennings, Cowen]

Hi, good morning. Thanks for taking the questions and congratulations on the strong 3Q results. Hopefully, Rob, hoping to just hear some puts and takes, or help us understand some of the puts and takes of 2022 operating margin. Clearly, COVID testing is going to be a factor. But any other drivers of operating margin expansion that you would highlight as we move into 2022. And then any other levers that Abbott 's able to pull to drive earnings next year, depending on how the COVID testing environment plays out.

[Robert Ford, CEO]

Sure. I'd say -- like I said in the beginning, I think 2022, our base business or underlying base business is going to grow very strong both on the top and the bottom. So we'll see margin expansion in that -- in that business, and that's a combination. Like Bob said, we've got gross margin improvement teams across all of our business that are working at ways to mitigate other manufacturing costs. So that will be important to be able to drive margin expansion. And then just the nature of the mix as we continue to roll out our pipeline, which is predominantly focused, I'd say on the med device side.

We've got gross margin profiles there that are accretive to the Company's gross margin. so I think a lot of it is really driven on the top line and driving our top line, and the execution of these new product launches allows us to get that margin expansion into 2022. And like I said, we -- the COVID piece is really just one where we're going to have to go quarter-by-quarter and update and roll our forecast every quarter. We'll have a number that we'll feel comfortable with. But those -- I would say those are the key drivers here.

Our product launches our ongoing base business, margin expansions by mix, and gross margin improvement. I want to keep the same profiles that we've got right now in our base business in terms of spend, R&D and SG &A. So those profiles we wouldn't want to maintain. Obviously, if you look at our profiles right now, it's a little bit distorted because of the COVID piece. But if you look historically where we've been in the low 7's in R&D and SG &A between 20% and 30%, that's where we're going to want to land.

[Josh Jennings, Cowen]

Thanks for that. And then a quick follow-up on Libre. We've had some consultants talk about a potential for Abbott to add other analytes onto the platform and particularly the addition of key term monitoring as a potential competitive advantage. Any updates just in terms of how the 3.0 on tap here. But any updates in terms of the future development plans for Libre and how you continue to maintain your competitive edge here. Thanks for taking the questions.

[Robert Ford, CEO]

Sure. We've always said that Libre was a platform. We always see and I know every time you put out a number, it becomes the next -- what is that and what's after that? And so we have launched Libre 2. It's doing very well in the U.S. We've launched Libre 3 in Europe. And we'll obviously be rolling Libre 3 out. Regarding your question on analytes, yeah, that is an area that we are intentionally looking at, which is using the platform of Libre, the manufacturing platform, to be able to develop new analytes. You mentioned one that we've got particularly experience in, in our blood glucose monitoring, we have blood ketone system.

So that we believe is an important aspect specialty for type 1 and pumpers. We think that that's a real important kind of feature. If you look at going into the Type-2 population, there's a lot of new drugs for Type 2 where there are certain warnings regarding DKA and we think that that might also be an opportunity too. But that's only one Anulette and we've got a pipeline here of Anulette, a dedicated team that's only focused on looking at what are the business opportunities the market needs for that. And as we get closer to those launches, which will be coming up fairly soon, we'll be updating the market, but I'm really excited about using the Libre platform here to be able to kind of expand even beyond diabetes.

[Josh Jennings, Cowen]

Great, thanks so much.

[Operator]

Thank you. Our next question comes from Larry Biegelsen from Wells Fargo. Your line is open.

[Larry Biegelsen, Wells Fargo]

Good morning. Thanks for taking the questions. Robert, I wanted to focus on the device side and the pipeline. Just starting with Amulet, to ask Bob 's earlier question another way, the surveys seem to be coming back suggesting Amulet can take about 1/3 of the U.S. market, and maybe even 20% next year. It's not easy for a second to market, to become a market leader. But Amulet has a nice profile. What's your reaction to some of these consensus estimates for share? Do you think you can do better? And I had a follow-up.

[Bob Funck, Executive Vice President]

Sure. Well, Amulet is new to the US, but it's not new to the international markets. When you look at the international market, Amulet's got a 50% market share. I've seen some of the reports, not all of them, but I'm aware of some of these surveys that are done with different physicians. And what I read and what I see of them is similar -- what I see here in the US, versus what we actually see it in Europe, which is a great product. It's size portfolio is an advantage. It's closure rate is also an advantage. And yeah, as I said, this is a multi-billion-dollar market where we think that we can be a true competitor in also.

But at the same time invest to develop it. I think that's an important part here also, Larry. So as I mentioned, we're making investments in next-generation product. We're going to be making investments in the commercial infrastructure, which is not only to be there during the implant, but also to develop the patient referral network and we're going to be investing in clinical trials. I think the catalyst trial is going to be comparing it to NOAC 's. I think that'll be a great opportunity to expand the market also. So it is a combination of market expansion. And, yeah, we're competitive with our offering., we’re competitive with our team, and I think 50% internationally is a good aspiration to have here in the U.S.

[Larry Biegelsen, Wells Fargo]

That's helpful. And then I wanted to ask about Portico and CardioMEMS. So with Portico, you have Navitor outside the US. Do you think you need that in the US to really drive share? And do you think you can compete without an intermediate and low-risk indication, which I don't think you'll have to about 2024? And just lastly on CardioMems, how are you feeling about the label expansion and the commercial opportunity given the COVID impact you mentioned on the GUIDE-HF trial? Thanks for taking the questions.

[Bob Funck, Executive Vice President]

Sure Larry. Let me let me talk about Portico and TAVI here more broadly. This is a hugely important segment in Structural Heart. We want to be a Structural Heart leader. We had that vision when we put the businesses together with St. Jude and we know that we need to be a true player here in the TAVI space. So I'm really looking at this for us as a long game. And what I mean by that is we're launching Portico in the U.S. Navitor to your question, is a great second-generation device. We got it, CE marked, and feedback is, that it's a very, very competitive device. Its clinical profile in high risk is really strong. And yes, I want to bring it to the U.S. also. But not because I feel we need to because Portico is not competitive -- Portico is very competitive.

But in this context of building a strategy here to be a real player in the TAVI space, we know that we're going to have to bring a second-generation here in the U.S. We will have to also look about how do we develop further on Abbott for a site. I think that we've got about a 5 share in Europe. That's not my aspiration for the TAVI space. To your point, there's two pretty well entrenched competitors in the market, but we have a higher aspiration and it's just a five share, which is what we have in Europe. So I think the combination here of investment in the team, investment in the pipeline, in the clinical data, you're right, are low risk. Intermediate, low-risk trial leads out a little bit later on, but it's there.

We're investing in it because we see this as a big opportunity for us to be a real player in this market. So I'm excited about it, and I know the team is too, to be able to be a real -- a go-to full-service player in the field of structural heart. Regarding CardioMEMS, I think the data, I think was pretty compelling. This is the second and you know this Larry, this is the second RCT trial that we've done. And I'm a big believer in RCT trials and the need for them to be able to generate the clinical evidence. We filed for the label expansion the end of June.

I think the data was very compelling. And part of it is expansion from -- expansion to Class 2 and Class 4. And then also to be able to expand indication to patients with Elevated BNP, which is today just for patients that have been previously hospitalized. So I think the combination here of the data, the fact that it is already the second RCT that we've done. A very large one also on top of Champions, the CHAMPION s trial. I think there's a great opportunity here for us to develop this market.

One of the things that we did in the quarter here also is we now have a more dedicated business unit for heart failure, where both the LVAD and CardioMems team are going to be combined into one, under one GM. Very similar to what we've done with our other businesses, because we believe in the benefit of that focus and that attention to the business. I think the combination of what we've submitted, our focus, this is a great opportunity for us in 2022 and beyond. I'm not going to comment on

[Robert Ford, CEO]

when -- all I can tell you is we filed it at the end of Q2, and I think the data is very strong and we'll just leave it like that. And I'm highly hopeful that we'll be seeing that next year, for sure.

[Larry Biegelsen, Wells Fargo]

Thanks, Robert.

[Operator]

Thank you. Our next question comes from Cecilia Furlong from Morgan Stanley. Your line is open.

[Cecilia Furlong, Morgan Stanley]

Thank you for taking the questions. I wanted to ask about [Indiscernible] business, SCS, as well as other deferrable procedures. And can you walk through just sequential trends in the quarter if you've started to see recovery in terms of your more deferrable procedures trending ahead of others. And also how you're thinking about the ability to recapture deferred procedures with the majority of procedure recapture can occur in 4Q or staffing shortages. Do some of those recovering procedure recapture flow into 2022.

[Robert Ford, CEO]

Sure. I would say this is probably out of our device businesses. The business that's had a little bit of a harder time in terms of recovering post COVID. It's probably more elective like you said, Cecilia. So it has been lagging a bit. It's been pretty flat, I would say, in terms of its trajectory if we look at our trials and -- and our implants. So, but that's really something that we can control in terms of how that is going to bounce back.

And we have visibility to the pipeline of patients. We work closely with the surgery centers, and we've got visibility to that. We're not expecting a big bolus to come into Q4 and then we'll have to see how Q1 and Q2 of next year looks like, to give it a better sense there. But what we can control, and that's what I focus, we focus the team on is on our pipeline, and I think the team here has done a really good job, I'd highlight a couple of things here that we've done, NeuroSphere, which is this novel remote care platform.

We've launched it. It's the first kind of system that was approved by the FDA. We did a full market release at the end of June, and I really like the numbers we're seeing. We've done over 5,000 remote programming sessions. And not only is it a remote program or but it also allows us to get visibility of the patients in the funnel. So using the adoption of that tool as great because I think it'll, it'll have a real big change on the sales and service kind of business model that exists in this business. so that's going very well, and I think that'll help get better visibility. Another key thing here is entrants into the rechargeable -- the chargeable segment, which is about half of the market.

We really don't have the competitive system in there and the team has developed a rechargeable system that is best-in-class, significant advantages versus the market leaders in this segment. So we're looking forward to bringing that product to market next year. And then we've also made investments in trials. I think probably the most notably one is distinct, which is an indication for non-surgical lower back. We've completed enrollment in that study. So I think the combination of these factors here are important for us to be able to kind of take share. And then if we see the bolus of patients come back in Q1 and Q2, that'll be an additional tailwind for us.

[Cecilia Furlong, Morgan Stanley]

Thank you, and I wanted to ask as well about your recent acquisition of Walk Vascular and really at a high level, can you talk about your outlook? Just for the underlying market growth in the peripheral space over the next several years versus some of your other high-growth target end markets, including diabetes and EEP. And are there other areas you book to build out around your Vascular business, and beyond that to just what's your current outlook for pursuing a P E indication for the thrombectomy system? And thank you.

[Robert Ford, CEO]

Sure. So we've been looking at this area for quite a bit. I've always said, we're always looking, we're always studying. And this was an opportunity that we saw. We think it's a -- it's an attractive segment. We see at about $700 million growing double-digits. And this kind of fell right into that sweet spot of strategic -- makes sense strategically for us, we've got a commercial footprint out there with a with an end vascular sales and service team. We know the customers, we have the call point and we've got the capacity here to be able to leverage our manufacturing expertise here, to scale up manufacturing.

So this made perfect sense for us to be able to add it to the portfolio and that integration is going pretty well. I don't expect any significant contributions in Q4, but as we go into next year, I think it'll have an impact on our vascular business. And yes, I mean, we're -- like I said, there are plenty of segments in the endo space I would say that we continue to study, we continue to look at, areas that we're interested in.

And if we find the right moment for us to be able to add those opportunities, we will. Regarding your question on the P indication, yes, absolutely. We know that is very important in the peripheral space. So we're investing -- that's one of the key aspects in the integration is to invest, to be able to get that indication established. So yes, we are working on that.

[Cecilia Furlong, Morgan Stanley]

Thank you very much.

[Operator]

Thank you. Our next question comes from Vijay Kumar from Evercore ISI. Your line is open.

[Vijay Kumar, Evercore ISI]

Hey guys, thanks for taking my question. Robert, my first one was, going back to testing, I think your Q4 assumptions of 1 to 1.4 billion, that's a sequential step-down versus 2Q. I'm curious, where are we on capacity right now. What is the demand for these testing products right now? Are we seeing any sequential step-down in demand right now? And I think you guys did win about $600 Million this year, DoD contracts. Is that baked into the Q4 number or is that a fiscal 22 contributor?

[Robert Ford, CEO]

Okay. So regarding the Q4 forecast of 1214 here, our capacity is we can do significantly more than that. Vijay, especially as we've -- Q3, we didn't have the full ramp-up, but now we're finishing this month here, we'll be in full ramp -up mode. So we can do, we can do more than the 1,4. I think the factor here that we're looking at is, as I said in the opening comments during the first question, I continue to see the surveillance in the screening market, to continue to increase, And that's with Buying X and [Indiscernible] (ph) now also. So we've got those businesses. Everything we can make, we're rolling in here.

I would say the only question we've got here a little bit is on make; the symptomatic and that's what you see maybe in this step-down here, is assuming as cases decline in the U.S. that we're going to see a little bit of a decline in symptomatic testing. So that's a little -- that's one part of the factor. The other factor in the 1214 is just pricing. We've got a market leadership position in rapid testing, especially in OTC. If you look at Nielsen data, you will be able to see that we were at about 90% share before the month of September, we dropped to about 60% just because of supply and now we're back up to 75 share and we're seeing a bit of price pressure.

So in that number I baked in some price pressure to ensure that we maintain that market leadership position as we saw -- as we see more market entrants come in. But if we don't need that price, then that will obviously drive another beat to that number too. But -- so that's -- those are the drivers and the thinking there, Vijay. A little bit of pricing pressure and what are we going to see on the symptomatic testing.

[Vijay Kumar, Evercore ISI]

So sorry. And now, the DoD contract $600 million, is that assumed in Q4 or instead of fiscal '22 contributor?

[Robert Ford, CEO]

Well, we're going to have to -- yes. So the DoD contract is actually -- I think you're quoting the So, maximum amount of the contract, which I know is kind of what got a lot of the news headlines. But the contract actually has a minimum amount, which is significantly lower than that. Less than a $100 million. So it's really going to depend here on the DoD and the Federal Government in terms of their purchasing. We factored in a little bit of that minimum piece in Q4, and as I talked about going into next year, that will be a portion of the part that we will feel comfortable with adding on. But it's a pretty big range Vijay, in terms of what the maximum is and what the minimum is so --

[Vijay Kumar, Evercore ISI]

Understood. And just one on your earlier comments, Robert, on the SG&A, looking back at historical trends of 29% to 30% R&D at 7% of revenues. Was that comment referring to fiscal '22? What OpEx as a percentage of revenue should look like for your base business. And then the variable over and beyond COVID. Is that the right way to think about fiscal --

[Robert Ford, CEO]

No. That was -- that comment was more about ensuring that we don't -- you don't see that there is a drop in investment. When you look at our profile in Q3 in terms of R&D, it's down to 6% or SG &A down to 25%. So that comment was more about there's a little bit of a distortion factor here because of COVID, and we're going to make sure that we continue to invest in the business. If you look at the investment we've made, Vijay, this year, we've added about fiscal [Indiscernible] a $1 billion between R&D and SG &A to the business so that we can continue to drive the top line and at the same time drive the long-term sustainability of the business with the R&D investments.

I talked about how we could pulsate that spend, not only this year, but as we go into next year, a portion of that spend is a little bit more discretionary on the SG &E side and we'll be looking at that. But the comment there was more about ensuring that there wasn't a distortion. You at least understood the distortion of COVID in terms of our profiles.

[Vijay Kumar, Evercore ISI]

Thank you guys.

[Operator]

Thank you. Our next question comes from Matt Miksic from Credit Suisse. Your line is open.

[Matt Miksic, Credit Suisse]

Hi, thanks and congrats on the strong results. So maybe just to follow-up on some of the things you were just talking about trough this concept of reinvesting the proceeds of this very strong COVID business. So there's a perception out there, I think because COVID testing is maybe not permanent and hard to predict that it's somehow less important or harder to value than the rest of your businesses.

But the last few months, obviously, in this quarter, 1.5 billion of upside in Q3 is by our estimates more than 0.5 billion in operating cash and that goes up against your $2 billion or $2.5 billion operating cash run rate. So the question is, in addition to being part of the solution as you've talked about, to the pandemic, maybe drill down a little bit into some of the things you were just describing, opportunities to invest behind which ones of your growth programs do you see an opportunity to sort of dial things up? And how, if at all, does this change maybe the way you think about M&A and your activity on that front? Thanks.

[Robert Ford, CEO]

Sure. I think you captured pretty well all the elements there of how we look at COVID. As I said in the beginning, when we started this, there's definitely an opportunity to accelerate the strategy of decentralized testing because of COVID and that strategy has been in place and that's an area that we are investing to ensure that we do have an ability to So we see more testing in the pharmacy, more testing in urgent care centers, and testing that goes beyond COVID, that even goes beyond flu and RSV and 340 viruses by developing assays that will be used on that rapid testing platform.

So that's one investment for sure. You can see the impact on investment on some of the business. You see it in nutrition. So we have been putting more [Indiscernible] advertising and direct consumer promotion in that business. And you could see the step-up in the growth rate there. We've obviously put investment into Libre, both on the SG &A side. You see -- we've rolled out a new TV commercial and funded that to a level that we feel is competitive, is leading in terms of messaging.

Increased our sales force in the U.S. and other key markets for Libre, so that we can call on more physicians, and you see the impact there on Libre. I mean, we did almost a billion dollars of sales of Libre this quarter, and in the U.S. is about 65%. We're making great progress in penetrating the tight to population, whether it's non-insulin users or non-intensive insulin users. We got about a 90% market shares, non-insulin users or non-intensive insulin users. We've got about a 90% market share of that segment, at least. So that growth is also being supported. And we've got all these new product launches that I've been talking about on the cardiovascular side that require feet on the street, whether it's Salesforce, clinical specialists, and we're funding that also, so I think that that's very clearly where we're putting our investments.

We talked about R&D investments and making sure that we've got pipeline beyond 22 and 23. And that's predominantly been in the diagnostics and device areas also. So it's been pretty broad base that billion-dollar increase has kind of gone well across all the businesses. And then if I asked my general managers and my Presidents of my businesses, do they have a next tranche to where they would go? they would have that list ready to go to. So there's no shortage of opportunity.

And then the other topic you talked about or touched on was the cash flow generation. And as a result of the COVID business and yes, it has generated a lot of cash. We have invested some of that cash in the organic opportunities we have, whether it's manufacturing sites through in the US for COVID, for MitraClip, for Libre. So we've made those internal investments, but we've also looked at where we could provide the best return to our shareholders. And you saw that in the form of our dividend increase. At the beginning of this year, we increased our dividend by 20% -- 25%. You saw that we also -- probably saw that we bought back shares in Q2, and we've stepped that up even further in Q3.

And we got capacity to do more of that in Q4 if that makes sense for our shareholders. So we find a way to deploy that capital. And on the M&A side, I've talked about this, we think there is a strategic fit for us, 1 that is financially justified for us, that we can do better with it, that we can make it better, and that there's value for shareholders, we'll do that also. Right now, I'd say I think the MedTech and diagnostic valuations out there, especially the ones that we would be interested in, and high-quality, high-growth assets is a little bit frothy. So we're in the mode of studying and paying attention.

I think the good news here is that, we don't really need M&A to be able to support what I think is pretty top-tier performance here. So that's -- it's pretty comprehensive in terms of how we're looking at COVID and both funds are internal organic growth and allows us to either provide some more value to shareholders through buybacks, dividends and if there's a growth vehicle out there, I think we makes sense, we won't be shy for that also. So I'll just close here a little bit and just say our results, we're archiving very strong growth across all of our businesses. I'm very excited and proud about the pipeline that all the businesses have been focused on.

We've historically really focused on our organic pipelines and that continues to be highly productive. We're entering to very new and attractive gross segments across our portfolio, and there's more products along the way there. We're investing in our key platforms, as I've said. COVID testing is going to be an important companion to vaccines and therapeutics. At what level, I can't say right now for next year. I've given a range on what I think is going to look like in Q4. And there could be opportunities there for us to -- first to do better than that. But I think the rapid test here is really the value proposition that's going to make sense going into next

[Robert Ford, CEO]

year and we're a leader in that segment. We built scale, we built manufacturing, and we know how to operate in this environment whether it's retail pharmacies or direct consumer. So our focus right now is we're going to finish strong 2021, enter into 2022 with a lot of momentum, and I think we're well placed strategically here as we go into next year. With that, I'll thank you all for joining us today.

[Scott Leinenweber, Vice President]

Thank you, Operator, and thank you for all of your questions. This now concludes Abbott's conference call. A webcast replay of this call will be available after 11 AM Central Time today on Abbott's Investor Relations website at abbottinvestor.com. Thank you for joining us today.

[Operator]

This concludes today's conference call. Thank you for participating. You may now disconnect. Everyone, have a great day.