美國雅培 (ABT) 2018 Q4 法說會逐字稿

Good morning, and thank you for standing by.

Welcome to Abbott's Fourth Quarter 2018 Earnings Conference Call.

(Operator Instructions) 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.

It cannot be recorded or rebroadcast without Abbott's express written permission.

I would now like to introduce Mr. Scott Leinenweber, Vice President, Investor Relations, Licensing and Acquisitions.

Good morning, and thank you for joining us.

With me today are Miles White, Chairman of the Board and Chief Executive Officer; and Brian Yoor, Executive Vice President, Finance and Chief Financial Officer.

Miles will provide opening remarks, and Brian will discuss our performance and outlook in more detail.

Following their comments, Miles, Brian and I will 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 the expected financial results for 2019.

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 Securities and Exchange Commission Form 10-K for the year ended December 31, 2017.

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.

Please note that fourth quarter financial results and guidance provided on the call today for sales, EPS and line items of the P&L will be for continuing operations only.

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 is defined in our earnings news release issued earlier today.

With that, I will now turn the call over to Miles.

Thanks, Scott, and good morning.

Today, I'll discuss our 2018 results as well as our outlook for 2019.

For the full year 2018, we achieved ongoing earnings per share of $2.88, representing 15% growth versus the prior year.

Strong performance across our businesses, along with underlying margin expansion and our synergy capture from recent acquisitions, enabled us to achieve EPS at the upper end of the initial guidance range we issued at the beginning of last year despite unfavorable currency shifts as we progressed through the year.

With our recent strategic shaping completed, our focus in 2018 was on running the company we've built, and the result was an excellent year by every measure.

All 4 of our major businesses performed well, contributing to overall organic sales growth of more than 7%, which is above the initial guidance range we set at the beginning of last year.

At the same time, we generated operating cash flow of more than $6 billion, returning $2 billion to shareholders in the form of dividends, and announced a 14% increase in our dividend beginning this year.

We also increased our investments in capabilities for the future, including expanding manufacturing capacity in 2 important areas that will drive significant long-term growth: FreeStyle Libre, our revolutionary continuous glucose monitoring system; and Alinity, our family of highly differentiated diagnostic systems.

And lastly, following 2 major acquisitions in 2017, we repaid more than $8 billion of debt, which significantly enhances our strategic flexibility going forward.

Our performance this past year demonstrates the strength of our strategy and execution.

And for 2019, we're forecasting another year of strong financial performance.

As we announced this morning, we forecast organic sales growth of 6.5% to 7.5% and adjusted earnings per share of $3.15 to $3.25, reflecting double-digit growth.

I'll now provide a brief overview of our 2018 results and 2019 outlook for each business.

I'll start with Nutrition, where sales increased mid-single digits in 2018, reflecting a notable improvement in our growth rate versus the prior year.

Sales growth this past year was well balanced across our Pediatric and Adult Nutrition businesses.

Internationally, our focus on enhancing competitiveness with our well-known and trusted brands led to strong growth in both Asia and Latin America.

In China, we saw improvement in both the market and our performance after the government transitioned to new food safety regulations in that country at the beginning of last year.

And in the U.S., growth was driven by our Pediatric Nutrition business, led by above-market growth of Similac, our market-leading infant formula brand; and Pedialyte, our market-leading rehydration brand.

Overall, the fundamental demographic and socioeconomic trends in the global nutrition market remain favorable, and our position in the market remains very competitive.

In Established Pharmaceuticals, or EPD, sales grew 7% in 2018, led by double-digit growth in both India and China.

Our strategy in EPD is unique and quite simple: to build significant presence, scale and leadership positions in the most attractive emerging markets where long-term growth in medicines will be driven by aging populations and the related rise in chronic diseases, increasing incomes and expanding access to care.

We've built our business over time through a series of strategic steps to be powered globally but driven locally.

Our global scale sets us apart and provides a unique competitive advantage versus local players, particularly when it comes to manufacturing and innovation.

And our local decision-making allows us to be nimble and navigate the complexities of each country.

Health care spending in most emerging markets is less than half that of developed markets, which means there's lots of room for future growth.

And our focus continues to be on strong execution across all elements of our business model to capitalize on the growth opportunities ahead.

Moving to Diagnostics, where we've consistently achieved above-market growth with our leading platforms.

2018 was no different with global organic sales growth of 7%.

This past year was particularly important as we accelerated the launch of Alinity, our family of highly differentiated instruments in Europe and other international markets.

Customer feedback has been outstanding, which, quite frankly, isn't a surprise to us given that Alinity was designed based on countless hours of listening to and observing the needs of our customers.

These systems are designed to be more efficient, running more tests in less space, generating results faster, minimizing human errors while continuing to provide quality results.

In 2019, while the international launch continues to gain momentum, we anticipate obtaining U.S. regulatory approvals for a critical mass of our test menu over the coming months, which will allow us to accelerate the launch of Alinity in the U.S. later this year.

2018 was also an important year for our newly formed Rapid Diagnostics business.

We achieved our sales and synergy targets for the year and are very pleased with the pace and progress of the integration of this business.

We also made important advancements in our pipeline with new product launches in the areas of diabetes and cardiac care as well as molecular rapid tests for infectious diseases.

These new products, along with continued focus on strong execution across our portfolio, will drive accelerated growth for this business going forward.

And lastly, I'll cover Medical Devices, where sales grew 9% in 2018, exceeding the initial guidance range we set at the beginning of the year.

Strong growth this past year was led by several areas, including Electrophysiology, Structural Heart and Diabetes Care, as well as stabilization in our Rhythm Management and Vascular businesses.

In Electrophysiology, growth of 20% was led by our heart mapping and ablation portfolio.

During the year, we advanced our product portfolio in this area with the launch of our Advisor HD Catheter, which creates highly detailed maps of the heart.

And earlier this week, we announced U.S. FDA approval of our innovative TactiCath Sensor Enabled Catheter, which will further strengthen our competitiveness in this highly underpenetrated market.

In Structural Heart, 2018 was a landmark year for our business.

We achieved double-digit growth and, perhaps more importantly, announced clinical trial results for MitraClip, our market-leading device for the minimally invasive repair of the mitral valve, which demonstrated improved survival and clinical outcomes in patients with the most prevalent form of this heart disease.

We submitted this study data to the U.S. FDA during the fourth quarter to support consideration of an expanded indication for MitraClip.

If approved, this advancement would further enhance our leadership position in this large and highly underpenetrated disease area and offer the potential to create a new multibillion-dollar cardiac device market over time.

And lastly, in Diabetes Care, we achieved growth of 35% in 2018.

Growth was led by FreeStyle Libre, which achieved global sales of more than $1 billion, an increase of 100% versus the prior year.

During the fourth quarter, we added 300,000 new users.

As of the end of 2018, there are now approximately 1.3 million active users worldwide, of which approximately 2/3 are type 1 diabetics and 1/3 are type 2.

In the U.S., we saw an accelerating trend of new users as we ramped up our awareness efforts during the second half of the year, and pharmacy insurance coverage continued to increase, including an emerging trend of seeing Libre granted preferred copay status versus competitive systems due to its compelling overall value proposition.

In Europe, during the fourth quarter, we initiated the launch of Libre 2.0, which includes optional alarms that warn patients if glucose levels fallout range.

Due to our unique product design and a highly automated manufacturing process, we're able to offer this feature to Libre users without increasing the cash pay price.

This affordable and simple-to-use device is fundamentally changing the way people with diabetes manage their disease.

And given the fact that more than 400 million people are living with diabetes around the world, Libre promises to be a significant growth driver for years to come.

So in summary, 2018 was another outstanding year for us.

We achieved our strategic and financial objectives despite challenging currency shifts during the year.

Our top-tier performance demonstrates the strength of our strategy, our portfolio and our execution.

And for 2019, we're forecasting continued strong organic sales growth and double-digit EPS growth.

I'll now turn the call over to Brian to discuss our 2018 results and our 2019 outlook in a bit more detail.

Brian?

Thanks, Miles.

As Scott mentioned earlier, please note that all references 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 fourth quarter increased 6.4% on an organic basis, in line with our guidance of mid- to high single-digit growth.

Rapid Diagnostics, which was acquired in late 2017 and is therefore not included in our 2018 organic sales growth results, achieved sales of $548 million.

Exchange had an unfavorable year-over-year impact of 3.7% on fourth quarter sales.

During the quarter, we saw the U.S. dollar continue to strengthen modestly, resulting in a somewhat larger unfavorable impact on our results in the fourth quarter compared to expectations had exchange rates held steady since the time of our earnings call in October.

Regarding other aspects of the P&L, the adjusted gross margin ratio was 59.3% of sales, adjusted R&D investment was 7.2% of sales, and adjusted SG&A expense was 29.2% of sales.

Overall, as we look back at 2018, we delivered strong organic sales growth of more than 7%, adjusted earnings per share growth of 15% and exceeded our cash flow and debt repayment objectives.

Turning to our outlook for the full year 2019.

Today, we issued guidance for adjusted earnings per share of $3.15 to $3.25.

For the full year, we forecast organic sales growth of 6.5% to 7.5%.

Based on current rates, we would expect exchange to have an unfavorable impact of approximately 3% on our full year reported sales, with the vast majority of the impact expected to occur in the first half of the year.

We forecast an adjusted gross margin ratio of somewhat above 59.5% of sales for the full year, which reflects underlying gross margin improvement across our businesses, partially offset by the impact of currency.

We forecast adjusted R&D investment of around 7.5% of sales and adjusted SG&A expense of approximately 29.5% of sales.

We forecast net interest expense of around $600 million and nonoperating income of around $200 million.

Lastly, we forecast an adjusted tax rate of around 15% for the full year 2019, which contemplates the anticipated impact from U.S. tax reform.

Turning to our outlook for the first quarter.

We forecast adjusted EPS of $0.60 to $0.62, which reflects strong double-digit underlying growth, partially offset by the impact of foreign exchange on our results.

We forecast organic sales growth of a little less than 7%, which contemplates a difficult comparison versus the first quarter of last year, when we saw abnormally strong sales in our Rapid Diagnostics business due to a record flu season.

At current rates, we would expect exchange to have a negative impact of around 5.5% on our first quarter reported sales.

We forecast an adjusted gross margin ratio of around 58.5% of sales, adjusted R&D investment of around 7.5% of sales and adjusted SG&A expense of somewhat above 32% of sales.

Before we open the call for questions, I'll now provide a quick overview of our first quarter and full year organic sales growth outlook by business.

For Established Pharmaceuticals, we forecast mid-single-digit growth in the first quarter, which is comprised of mid- to high single-digit growth in our priority key emerging markets, along with a modest decline in other EPD sales, which reflects the recent discontinuation of a noncore low-margin third-party supply agreement.

For the full year, we forecast Established Pharmaceuticals growth of mid- to high-single digits.

In Nutrition, we forecast low- to mid-single-digit growth for both the first quarter and the full year.

In Diagnostics, we forecast Abbott's legacy Diagnostics businesses, which is comprised of Core Laboratory, Molecular and Point of Care, to grow mid- to high-single digits for both the first quarter and full year, driven by the continued strong sales momentum across our portfolio of instruments.

Rapid Diagnostics, which will now be included in our organic sales growth results in 2019, is expected to be relatively flat in the first quarter, reflecting the difficult flu season comparison I mentioned earlier.

For the full year, we forecast Rapid Diagnostics growth of low- to mid-single digits.

And in Medical Devices, we forecast high single-digit sales growth for both the first quarter and the full year, which reflects continued double-digit growth in several areas of the business.

With that, we will now open the call for questions.

(Operator Instructions) And our first question will come from Matt Taylor from UBS.

Wanted to ask about FreeStyle Libre to start off.

You had another good quarter of patient adds, and it seems like you're expanding more into type 2 with the new disclosure.

Could you talk about the trends there, what's the 2.0 adds and some of your longer-term vision for Libre?

Yes, sure, Matt.

Well, a few things about Libre -- or actually several things about Libre.

First of all, it's going extremely well.

We did add 300,000 patients last quarter.

That's almost equivalent to the entire user base of the #2 competitor in the space.

So I'd say that's going very well.

We got over 1.3 million patients now.

2/3 of those are type 1. Our intent with this device has been to serve the entire diabetic community and not niche it because we think it has mass-market potential worldwide.

So we target both segments, both type 1 and type 2. And we're doing very well in type 1 segment -- the type 1 segment actually.

And as our capacity expands, we'll put even more effort behind the expansion with type 2 patients.

There's a constant, I'll say, cadence of enhancements, et cetera, to the product.

We've recently launched 2.0 in Europe.

That should come to the U.S. shortly.

We're -- we've obviously invested a fair bit in capacity expansion.

And at the rate we're adding patients, obviously, that's something we started paying attention to a couple of years ago.

And I'd say, a significant quantum of capacity will come online in the second half of this year.

And from my perspective, that allows us to open the floodgate much wider.

At this point, we're having a tremendous amount of success with Libre without putting much push behind it.

And at that point, we're going to have an ability to turn on a lot of push.

So -- and then we've got steady cadence of capacity additions after that.

And because of the magnitude and the size of the diabetic market, both for type 1 diabetics and type 2 diabetics, our view was this had to have a value proposition for patients and for the health care system that was accessible and affordable by everybody and not just driven by a rebate system and so forth.

So we've got a very low cost position.

We've got a good value access price point.

And I think all of that is playing through our markets and our patient groups and influence groups and so forth very well.

The product obviously is getting all the emphasis in development, et cetera, that anybody would like to see.

I think this is a very big, long-term, sustainable growth product for the company.

I don't have any other way to say it.

This is a happy, happy topic.

Yes, it's been phenomenal growth.

I was just curious, as you look forward in segmenting the market, you now have Libre 2 with alarms.

You have partnership with a pump company.

Can you talk about how you might bifurcate your strategy to go after different segments, whether you need low-cost offering and a higher feature offering as you kind of expand through the Libre portfolio?

Well, I think -- I'm going to be careful how much I say publicly on the phone.

I think you can assume that we're obviously developing every aspect of this product that you can imagine.

And that's all going very well.

I wouldn't communicate what I would forecast as time lines.

I think that the current growth rate speaks for itself.

The current submissions and features of the product that we're adding speak for themselves.

We're pretty highly focused on bringing that capacity online, and not because we're constrained yet, but right now, we're adding as, I said, 300,000 patients a quarter and growing.

And so you have to pay attention to keeping that momentum increasing.

And at this point, with that many patients and the magnitude of the opportunity, our intent is to make this very much a mass-market product.

But with 40 million type 1 diabetics out there, mass market means every one of those type 1 diabetics ought to be able to access this product economically, and that's worldwide.

And then of course, there's an enormous type 2 market beyond that.

So this is not a product that's targeted solely at type 1 or solely at type 2. Its accuracy and performance obviously has meaning and efficacy in all segments.

Our low -- our cost position is as low as anything in the industry.

We have probably #1 cost position, #1 volume of patients position.

I think we can pretty easily declare ourselves the leader in continuous glucose monitoring and growing faster than everybody else.

So I'd just say that all of the things that you would expect us to be doing, including working with other third-party partners who would benefit from this technology, all underway, have been for some time.

And our next question comes from Robbie Marcus from JPMorgan.

Miles, maybe I can ask a guidance question.

So Abbott's guidance for 2019 is 6.5% to 7.5%, basically in line with 2018 and a bit better than The Street was expecting to start the year.

So maybe you could give us a little background what your confidence is at the starting point?

And maybe specifically, touch on some of the key growth drivers for 2019 that people are focused on.

MitraClip, you talked about Libre, and maybe hit on an Alinity.

Yes.

Well, I think you've touched base there on several of them already.

What you should read into that guidance is we had an outstanding '18 and we just gave you guidance that's even better than '18.

And the underlying growth rates are strong.

The pipelines are strong.

It's all organic growth.

It's not dependent on lapping an acquisition.

It's not driven by lapping an acquisition.

It's not dependent on acquiring something.

And all the things that are driving our growth are coming right out of our own pipeline and launching globally.

So if I take that a piece at a time, Libre as a story just gets better and better and better.

So obviously, that's a pretty big and high-growth driver.

That's a good thing.

The Alinity program has had an outstanding year rolling out in the Core Lab, which is primarily driven by Europe.

And we haven't really unleashed it yet fully in the U.S. or even fully in Asian markets.

And as that menu reaches what I'll call critical mass, that will tip up as well.

And so far, everything we've seen with the rollout in Europe has been exceptional.

Our share capture, our retention of rolling over a lot of our own customers and our own installed base, our price point and value point were, I'd say, extremely competitive, but it's better than that.

And so that's going well, and that momentum only gets better as we expand geographies.

And frankly, there's a couple of aspects to that program that haven't really gone to market yet fully, our hematology piece, et cetera.

So I think those are strong drivers.

When we acquired Alere in the diagnostic space, it was a declining to slightly best -- at best, flat business.

And that's been a nice story for us in terms of integrating it.

We're going to be looking for now improving the growth of the new product pipeline and momentum going forward in that business, which is incrementally positive for the business.

As I already mentioned, Nutrition, compared to the prior 4, 5 years, has a nice, steady, sustainable forward-looking growth in the, let's call it, 3% to 5% range, somewhere in there.

And that's a plus, that's an upside.

The pipeline in devices is strong.

It's good.

I mean, we spoke earlier in the year about the COAPT trial driving MitraClip in Structural Heart.

And there's a nice pipeline of products and enhancements coming behind that.

We just launched or got approval for HeartMate 3 for destination therapy, some additional catheters in our Electrophysiology business that help us be even more competitive than the 20% growth rate we've got now.

Just everything across the board gets better.

Where do we see problems?

Well, we got a couple of places that we're not too happy about our own performance in.

We know neuromod is a super good growth business.

We expect to see sequentially improving growth out of that business over the course of the year.

I've talked about that on previous calls.

We believe we're in control of our destiny there.

And if we -- if anything, I probably estimated the speed at which we could correct our direction there wrong.

It's taken a little longer than I would have guessed.

But that's going to get sequentially better, and I think that's a plus.

The Point of Care business that's part of our Diagnostic business, not Alere but the -- our own Point of Care business, we had some corrections to make in our strategy, and we've done that.

And so I'm quite optimistic that our management team there has a good path, a good management team, et cetera.

That'll improve.

So if I had a concern at all, it's the things I can't control.

I think our fundamental underlying strategy in the pharmaceutical business is solid.

I think the underlying growth rates in emerging markets are solid.

I know the world worries about the volatility of those markets and the reliability of those markets and, in particular, currency.

And we're all going to live with currency if we're a multinational company, and I don't think we're any different.

And to be honest, we're not that differently indexed now with the addition of the Medical Devices and Diagnostics and so forth in the company.

So while we may have, let's call it, individual spotty circumstances in any given emerging market in any given year, which we kind of expect, I think the underlying growth of that business, driven by the development of those economies, the health care systems, is solid.

So I look at all aspects of the company.

Whenever we're not performing where we think we should in a given business, we do take corrective steps.

And as I look across the portfolio, every single business which had such a great year last year actually had a little better one this year or a lot better one this year and on a sustainable basis going forward.

So as I look forward into '19, I note that there's a lot of caution in the world about economies and any number of other things.

We base our growth rates and our growth projections on our products, on the market dynamics we see in each of our product areas in the segments we compete in.

And we've got a rich portfolio of products right now and a rich portfolio of products coming out of our organic R&D and a lot of longevity on the driving of those products in the market for years to come.

So whatever the windiness of the currency markets or other things may be, we've demonstrated through '18 and will demonstrate into '19 that we can power through that and continue to deliver the kind of growth that our shareholders reliably expect.

Great, that's really helpful.

And maybe one for Brian.

On the bottom line, EPS guidance implies growth of 9% to 13% on a reported basis, closer to mid-teens on a constant currency basis.

This is higher than what we've seen in the past from Abbott but also off the higher starting top line.

So as we go through the year, if there's incremental upside, how should investors think about the willingness to allow that to fall to the bottom line versus reinvesting in the business at these growth rates?

I'll defer to Miles on that question because I know he makes the choices ultimately between the balance of growth, the sustainable growth versus what we give back to shareholders.

But I think we've shown a good propensity to be balanced in that.

We showed that demonstration even last year as we gave some pennies back to The Street when we had a variable tax rate but invested heavily in the growth opportunities that Miles talked about that creates the kind of sustainable growth that we're looking for.

Your math is right.

I said back on the October call that exchange would be around 4% to the bottom line impact.

It's just a little touch above 4%.

You could imply that, that would mean about mid-teens EPS growth.

And even as you look at our quarters, I mentioned in my script that FX would be more front-end loaded.

It's a first half phenomenon.

But underlying growth that we're portraying here for the first quarter and the full year is pretty range-bound in that underlying double-digit earnings per share growth of the mid-teens, plus or minus a couple of points.

And there's a lot of underlying gross margin improvement still going on across our businesses.

There's a lot of synergy still being captured in gross margins as well as in SG&A as it pertains to our continued integration with St.

Jude and also with Rapid Diagnostics.

So you're seeing the margin expansion come through in our op margin line in our guidance.

Yes, I'd reiterate a couple of things.

This is Miles.

First of all, Brian mentioned, exchange, as we know it right now, is factored into our guidance, and we're still at a double-digit EPS growth.

The exchange that we're, I don't know, seeing in our guidance is a factor of last year, meaning '18, that we've got to lap.

And so it's that roll-through that is currently taking us from what otherwise would have been 15% to what at the midpoint would be 11%.

So we're still at healthy double digits and it's, in effect, caused by lapping last year's guidance.

None of us are currency traders, so there's no way to kind of predict what's going to happen with the year, and I hesitate to do so for fear that fates strike us down.

But with regard to profits and performance and so forth, I'd say the company has always been fortunate that it's had strong profits and strong cash flow.

And with regard to forecasting and so forth, we start every year with a double-digit target and a high bar, and that's our aspiration every single year.

And gosh, more often than not, that's where we start with our guidance.

Now having said that, out of the last 11 years -- and why do I not go back further than 11 years?

I don't have the data, but I could get it.

But in -- out of the last 44 quarters that we have reported, we have beat 39 of them, exceeded the investors' expectations, beat 39 of them and met on 5. And so I think the company has demonstrated that if it exceeds its expectations, if it exceeds Wall Street's expectations, if it exceeds in performance, we do share that back to our investors in increased profitability or increased return to the investor.

And there's no reason to see a change to that.

We've got strong cash flow.

We are able to cover all of our cash and investment needs from a capital standpoint, from a dividend standpoint.

We have the capacity to buy back shares to offset dilution and, frankly, buy back shares if it's the best investment that we can make.

We have the capacity to do M&A.

We've obviously been able to pay down a lot of debt and very, very rapidly so that we would have the balance sheet flexibility that we want.

So we had very strong performance, strong profitability, strong cash flow.

And so if we exceed our expectations and our performance, then obviously, we have the decision -- and that's a nice place to be.

We have the decision to share that with our investors, which is exactly what our investors would expect.

And you can tell that 90% of the quarters for the last 11 years, investors have benefited.

Our next question comes from David Lewis from Morgan Stanley.

Miles, just a couple for you.

In thinking about or listening to your commentary on 2019, the one comment that comes to mind was balance, your commentary that most businesses get better or a lot better.

That being said, a lot of investors are still very focused on Libre and MitraClip.

So as you think about the guidance and how it was formulated, how dependent is 2019 guidance on a significant inflection for MitraClip or a Libre 2 product launch?

Zero.

Okay, that's pretty clear.

I guess we can leave it at that.

The second point, so...

No, it is.

I mean -- I think, I mean, to be honest, I'm not trying to be coy with you.

It's very hard to predict what the regulatory timing will be, for example, on MitraClip.

So -- and there's no reason for us to kind of play with the number and play with something that we're not sure we can predict.

So what we do know is when it comes, which is very compelling -- there's a number of things that have to happen.

FDA has to approve it.

We obviously would want CMS to reimburse it and so on.

And I think it'll have that kind of compelling story with the regulatory bodies.

It's obviously -- the COAPT study was very powerful, and I think the regulatory bodies will give that all the right consideration.

But trying to pin that down and trying to pin down timing and so forth is not something that's easy to do.

And I'm not sure we'd be doing our investors any good service by trying to predict that.

What I do know is it's compelling.

When it comes, it'll come and it'll have impact.

And rather than put it in our estimates, we haven't.

Okay, very clear.

And then just following up on another point you made in this morning.

Thinking about the balance sheet, I mean, you went from 2 years ago an overlevered company to now, frankly, relative to peers an underlevered company.

I think debt paydown and free cash generation were sort of unsung heroes of last year.

So many of other companies have picked up the relative pace of M&A.

You're still growing at a pretty robust 7-plus percent rate without significant M&A the last couple of years.

So where do you stand now as you think about reinvestment for growth?

How active are you likely to be in '19 relative to '18 on the M&A front?

Well, I'd say a couple of things.

First of all, you earn your highest return on organic growth and not your highest return on M&A.

And then I mean, as you know, a lot of M&A deals struggle to return a good return to shareholders.

We've had, let's say, an excellent track record -- going back deep in our history with Knoll and Humira and so forth, we've had a really good track record with the M&A we've done over time.

And we've managed those companies and their products well over time.

So I'd say, first of all, you make much higher return on your organic growth.

The growth we're getting from all of our businesses and even St.

Jude is coming out of pipeline, and it's coming out of our own organic development, et cetera.

And right now, those are the highest returns, those are the highest, biggest opportunities, and we certainly don't see gaps right now that we have to fill with M&A.

So we're able to return a pretty good sales and profit growth rate across the business.

We've also been careful over time.

There's times to be in the M&A markets and there's times not to be.

And when multiples are really high, bad time to buy.

And -- but to be honest, I don't see anything right now that is so appealing that we feel like that's necessarily a good direction for us.

And the kinds of things we might look at, well, I would never tell you anyway, and you know that.

But right now, our opportunities are so good with our own organic products and execution that we don't need it.

And there's not something that's so attractive -- all of the various investment banking houses that you can imagine have put many things in front of us as opportunities as they do every company, et cetera.

So it's not like we're not aware of what opportunities may be out there.

It's just they wouldn't meet our criteria.

I don't see something compelling.

I don't see something that we need.

And right now, we're in a fortunate position where we've got very strong products and pipelines and strategies across all of our businesses.

I will say we can execute better in some places, but you can't buy that.

So we fix our own execution with our talent and strategies and so forth.

But it's just not necessary for us to put our money into M&A right now because I don't think we'd turn a better return for our shareholders now or at least in the foreseeable future doing that.

We're going to make a lot more money for our shareholders, investing in our growth, investing in the products we have, investing in our expansion, investing in our own capital.

And as you know, we have plenty of cash flow to do that, and we have plenty of cash flow that we can still return increasing dividends.

And at some point here, we'll have a choice.

We're going to keep paying down debt because I think it's a good idea.

Our debt -- net debt-to-EBITDA ratio now is below 2, and as you know, it was more like 4 to 4.3 when we completed the Alere and St.

Jude deals.

That wasn't that long ago.

So to have brought our net debt-to-EBITDA ratio down that far and that fast, and particularly, as we look forward in a rising interest rate environment or potentially so, depending on what you believe, I think we're doing the right things in the management of our balance sheet.

I wanted to get that debt down fast; we have.

I wanted to have strategic flexibility; we have it.

What I really want is capital allocation flexibility to earn the right returns and the optimal returns for our shareholders, and I think we're in that position.

So I just don't see M&A right now as a high priority.

Our next question comes from Joanne Wuensch from BMO Capital Markets.

I'm going to take the flip side of David's question.

Instead of thinking about M&A and adding things, how do you feel about having all 4 legs of the stool remain in the Abbott house?

I think there was some lay press discussion regarding a possible sale of the nutritionals business.

Well, I get that speculation, jeez, if I don't get it every quarter, it's almost every quarter.

So thanks for asking the question, Joanne.

We like our mix right now.

There's a role to everything in our portfolio.

And the one I'm asked more frequently about than anything is Nutrition.

And you can transact, you can try to make money for your shareholders with transactions, but I would say this: as you know, Joanne, I've been in this job a long time.

And earlier in my tenure, there was a role for Nutrition in our portfolio.

And I got the same question then.

And one of the roles was it's got a global presence, global infrastructure.

It's highly profitable, generates a lot of cash.

And a lot of the M&A activities and other things that we did back in my earlier years benefited from the cash flows and position of Nutrition.

And even today, there are great benefits to our Nutrition business to the company.

And that's not to say that any given part of the company has to be part of it.

It's clearly a different business as is our pharmaceutical business, et cetera.

But today, I'd say, look, it makes sense as part of our company.

I don't think we need to be considering a transaction just to do it.

We're well valued.

We're performing well.

I don't honestly think I would create more value for our investors by separating it.

If everybody asks you about it often enough, you go look at it.

Okay, I've looked at it.

I don't think we can create differential improved value for our shareholders than what is already being executed by us.

I think that's a plus.

I think that in general, while a lot of people might ask me about it, it's also performing well.

I'm happy that it's performing a lot better than it did for a couple of years there.

So it's just not on my radar screen.

I don't think we're going to improve Abbott.

I don't think we're going to create value by considering it.

And I think we'll distract ourselves with that at a time we don't even need to be distracted.

So it's just not on my radar screen as a way to create value for shareholders because I don't think it will.

And I think it's being well valued as part of Abbott as is the rest of Abbott.

So it's just not on my radar screen and -- nor do I think it's necessarily beneficial to us.

I guess that's the simplest thing to say.

Okay, appreciate that.

As a follow-up, 2 businesses I just want to talk about the pipeline.

Neuromod, what does it take to reaccelerate that growth rate?

And then you talked about an Alere pipeline, which I don't think The Street is really focused on.

If you could just give us some highlights there.

Yes.

So first of all, the single biggest thing that immediately will change how we're doing in neuromod is actually our sales force expansion in the U.S. and our training and execution there.

And that's what we're focused on.

Then longer term, we put a lot of emphasis in our R&D pipeline.

We have a number of new people, new management, broader pipeline under development, I'm not going to give you any kind of insights to it and so forth because I don't really want to get the world focused on it.

But it's an area where we think there's a lot of opportunity in the types of products we have.

We don't think we've sort of fully gotten the benefit of the 2 main products we have now.

And so I'd say it's got our attention.

We've doubled our investment in R&D there.

And I think in the coming years, we'll see that roll out.

What was the second part after neuromod?

Pipeline in Alere.

Rapid Diagnostics.

We've reorganized the Rapid Diagnostics business into 4 segments.

Each of them has their emphasis, their target.

Each has an R&D plan.

Each has a new product plan.

We are increasing our investment in R&D also there.

I can give you a couple of high points and examples.

Infectious disease product, ID now, which we think has got a lot of potential that we're rolling out.

The Afinion 2 cardiometabolic platform, another opportunity that we're putting emphasis behind.

But I think there's -- generally speaking, there's a lot more possibility for us in incrementally updating and renewing a number of these platforms, and then there's newer stuff than that.

And so when we took over the company, which we've now had in our possession a little over a year, one of our targets was to get our hands around the R&D of each of these segments and make sure we had an R&D plan in place, so there was a steady cadence of improvements and new products in each of these businesses.

That does take a little time.

In our first year, a lot of our focus was stabilizing the organization, its structure, the management, people, execution of what we've got, synergies, et cetera, which we've talked about.

Now our attention turns to this, and it has been.

I mean, we've been increasing our spending and increasing our focus on this.

And that's what the management team is focused on now, is that new product cadence.

So beyond that, I don't want to be more specific.

Otherwise, we'll be tracking it all here.

Our next question comes from Bob Hopkins from Bank of America.

Just wanted to follow up, if I might, on the commentary earlier on MitraClip given its visibility.

Can you just give us a sense as to what the growth rate of MitraClip was in the fourth quarter?

And then to be clear, relative to your earlier comments, do you really not assume U.S. approval and reimbursement for MitraClip in FMR at all in 2019?

Is that -- that's not assumed at all?

No, that's not what I said, and that's not what the question was.

I'm not assuming that.

But the question was whether or not that was pivotal to making our earnings guidance for the year or our sales guidance.

And the answer was, it has no bearing on our sales and earnings guidance for the year.

But you're asking me a different question now, do I expect approval?

And I'd say, well, we'll see.

I mean, we're certainly hopeful that we'll get that kind of consideration.

And is it possible?

I suppose it's possible, but we don't know.

We just don't know.

Scott?

Yes.

With respect to the MitraClip growth rate, MitraClip grew about 30% in the fourth quarter.

Okay.

So it accelerated a little bit.

Okay, I hear you on MitraClip.

And then the other sort of product-oriented question that I wanted to ask is that you mentioned in your remarks that Libre is getting some preferred copay status.

And I was just -- I found that intriguing.

I was just wondering if you could expand on what that means specifically, how broad the program is.

Is that just because Libre is a little lower cost?

Or are payers trying to incentivize patients to use Libre?

So maybe just a little color on the copay status.

Yes.

I mean, as you think about copay status and the way payers use it, that is essentially what they're trying to do, is they're trying to incent a preferred offering with respect to the value proposition that, that offering brings.

So as we progress in the second half of the year in our payer dialogue, we saw that certain payers were starting to put Libre in a higher tier, Tier 2, which would result for the end patient in a lower copay, quite frankly.

And again, I think as they look at the overall value proposition, the outcomes data and whatnot, they see a compelling argument to do it, and we're starting to see that trend.

Our next question comes from Glenn Novarro from RBC Capital Markets.

Two device questions.

First, on Rhythm Management in the quarter, down 2% to 3%.

Is that market softness?

Or are you guys just losing share to Boston Scientific because of their HeartLogic feature or losing share to Medtronic because they've got Micra, the leadless pacer?

So that's the first question.

And then the Vascular business, down 5% in the U.S. That would -- that's surprising to me given you're launching XIENCE Sierra.

So similar question, is this just the market is weaker in drug-eluting stents for the U.S.?

Is it more pricing pressure?

Or is the product simply not gaining traction?

Yes.

I'll start with Rhythm Management here.

And as you know, when we acquired that business, it was declining at a fairly heavy clip.

We've been able to stabilize it.

The overall market, to your point, is down modestly, and our performance is generally in line with that.

When it comes to Vascular, same thing.

Again, the market is down modestly.

XIENCE Sierra is doing well.

It's capturing share.

In fact, we gained about 5 share points since the launch of XIENCE Sierra.

Pricing in the space remains a challenge for all of the market, but XIENCE Sierra is definitely performing there.

And quite frankly, our performance overall is a little bit above the market.

Glenn, what you're also seeing there is a reduction in third-party royalty revenue, not share.

The stent and the system, XIENCE Sierra, are capturing share, but what you're seeing is the roll-through of loss of a third-party revenue.

Okay.

And one follow-up.

Can you give us an update on both your TAVR and mitral program?

TAVR, specifically Portico, when do we see a U.S. filing and approval?

And then mitral, update on Tendyne enrollment and then maybe comment on the latest acquisition.

Yes.

On TAVR, we would expect to file that here in the second half of this year.

We're wrapping up that trial as we speak.

With respect to Tendyne and Cephea, obviously, we're expanding them.

We've had a long-term vision here in the mitral space to really build a toolbox.

Tendyne, we filed actually for CE Mark before the end of last year.

So we could possibly see approval here this year.

The U.S. is still several years away.

And the Cephea program looks like a really great program, but again, still several years away.

And our final question comes from Rick Wise from Stifel.

Maybe just one big picture and one product question.

Brian has done and the team has done a fabulous job paying down debt.

You highlighted some thoughts about the -- your comfort in not doing M&A in today's portfolio.

Obviously, that suggests share buyback and dividend.

You've touched on it a little bit.

But just wondering, are you feeling strongly about taking your excess cash and dividing it equally depending on stock price?

I mean, do you have a priority?

Is there some -- how are you thinking about it?

No, I don't think about it as dividing it equally.

There's -- for any particular capital use, there's a timing, and there's -- or there's a need.

If we got to invest in capacity internally and manufacturing and so forth, obviously, that's a good thing.

And as I've said, we can afford all of that and more.

We're keeping our dividend healthy.

We target our dividend generally in a range 40% or higher of our EPS as a payout ratio, a nice healthy range.

And a number of our peer group don't do that at all.

So I think we've got a good healthy dividend.

And that matters to us because we have a large segment of investors that care about that.

With regard to M&A, M&A is necessarily opportunistic.

It depends on the product, the company, the business, the timing, market values, multiple, all sorts of things.

And right now, I don't see any of that lining up to say, "Wow, there's something we're dying to go look at." And then with regard to share buybacks, Rick, it sort of depends on valuations in the market.

There's times when share buybacks aren't that economical and other times when they're high return.

And on our case, right now, we've got the flexibility.

If we want to do any kind of share buyback just to offset dilution and so forth, we can do that.

And -- but I think you kind of -- you got to look at it and say, "Is that my best use of cash?" I still want to pay down debt.

I don't want to assume we're just going to carry this forward.

We paid down a lot of debt fast.

It would actually be in our interest to keep doing that, to keep paying it down.

I think we're well into a reasonable range now of debt, but we still want to keep paying that debt down.

And our cash flow is strong enough that we do have choice.

We do -- we have the ability to pay the dividend.

We have the ability to do all these things.

We can satisfy our capital needs internally.

So I think -- I guess the best thing about it is we don't think about it in any mechanistic or formula way, dividing it in half or whatever.

We kind of look at where the best -- where the need is and where the best return is.

And I think it behooves us to leave ourselves also in a very strong position at a lower debt level.

So we got places to use it and places to use it economically.

When -- before tax reform, when so much cash was trapped overseas, we were fortunate that we had M&A opportunities to invest that cash for good return.

We're not stuck like that now.

We can manage cash, manage the cash flows of the company and so forth far more efficiently in terms of the best returns or the best needs.

And that's kind of how we look at it.

If we find that our best use of the cash or a strong use of the cash is share buybacks, we'd certainly consider that.

But right now, I wouldn't say that's our highest priority either.

It's still a high priority to just keep paying down the debt.

And a couple of years down the road here, depending on what happens with interest rates and so forth, we'd probably be glad we did, and we'll have tremendous strategic flexibility and still have very strong cash flow.

So I think it just depends on circumstances at a given point in time.

Yes, that's a great answer.

And just last, maybe quickly, I know you love to talk about what could push you to the upper end of your 6.5% to 7% guidance for '19.

But there were some wild cards that helped out.

You exceeded your initial 2018 organic growth guidance in '18.

Maybe just touch on quickly, if you would, what could push you to the upper end or above for your '19 range?

Oh, I think there's -- Rick, I think there's a number of product things that could do that.

We've already mentioned MitraClip is a possibility.

And it wouldn't take a whole lot, a couple of ticks in any of these businesses of improvement.

Last year, our Nutrition business actually did better than we expected.

We thought it would do better than prior years, but it did better than that and better than we expected.

And some of those tick-ups make a big difference.

And so I think if we turn the corner as we expect to and plan to, things like neuromod and other places where we know the fundamental underlying business is strong, it doesn't take a whole lot to sort of correct the underperformance of some businesses, whether it's our Point of Care business or neuromod or some of individual countries in the pharmaceutical business.

And the upside here is fairly strong.

Very good.

Well, 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 11:00 a.m.

Central Time today on Abbott's Investor Relations website at abbottinvestor.com.

Thank you for joining us today.

Ladies and gentlemen, thank you for participating in today's conference.

This does conclude the program, and you may all disconnect.

Everyone, have a wonderful day.