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spk05: Good morning and thank you for standing by. Welcome to Abbott's fourth quarter 2019 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 keys on your touchtone phone. Should you become disconnected throughout this conference call, please redial the number provided to you in reference to Abbott earnings call. This call is being recorded by Abbott. With the exception of any participants' 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.
spk03: Good morning, and thank you for joining us. With me today are Miles White, Chairman of the Board and Chief Executive Officer of Robert Ford, President and Chief Operating Officer, and Brian Yor, Executive Vice President, Finance and Chief Financial Officer. Miles will provide opening remarks. Brian will discuss our performance and outlook in more detail. 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 the expected financial results for 2020. Abbott cautions that these forward-looking statements are subject to risk 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, 2018. 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 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 the Find Now earnings news release issued earlier today. With that, I will now turn the call over to Miles.
spk02: Okay, thanks, Scott. Good morning. Good morning. 2019 was another highly successful year for Abbott. Our focused execution resulted in strong financial performance, including ongoing earnings per share of $3.24, reflecting 12.5% growth on an absolute basis and even higher growth when excluding the impact of currency. All four of our businesses performed well, contributing to full-year organic sales growth of more than 7.5%, which is above the guidance range we set at the beginning of last year. The successful year was capped off by a strong fourth quarter with organic sales growth of 8.5%, including double-digit sales growth in medical devices, established pharmaceuticals, and core laboratory diagnostics, along with ongoing EPS growth of more than 17%. Our consistent, strong performance demonstrates that our business model is working exactly as intended. We've built the company very deliberately through a multi-year process to deliver superior results for years to come. We've shaped our businesses to align with important trends to make sure we're in the right places with the right products, and we've targeted businesses that are focused on some of the world's greatest health care concerns. For example, diabetes and cardiovascular disease are two of the most significant health care challenges of our lifetime. They're chronic, long-lasting, and dramatically increasing in prevalence around the world. Nearly every health care decision begins with a diagnostic test, and this testing not only occurs in the traditional hospital setting, but also increasingly at alternate sites such as physicians' offices, pharmacies, and even at home. Proper nutrition is a foundational element of good health across every stage of life, whether you're a newborn baby, a child striving to grow, or an aging adult working to overcome a health condition. And access to health care continues to expand rapidly in emerging markets where 85% of the world's population resides. We've shaped our company to achieve scale and leadership positions in all of these areas. The investments we've made and our focus on execution are working. Our product pipelines are strong, our operating culture is strong, and we're well positioned to achieve sustainable strong growth for years to come. For 2020, we're forecasting another year of top-tier financial performance. As we announced this morning, we forecast organic sales growth of 7% to 8%, and adjusted earnings per share of $3.55 to $3.65, reflecting double-digit growth. I'll now provide a brief overview of our 2019 results and 2020 outlook for each business, and I'll start with diagnostics, where sales grew 6.5% in the fourth quarter, led by double-digit growth in core laboratory testing. The rollout of Alinity continues to go well in Europe, where we're winning new business at a high rate, and successfully renewing existing contracts that come up for bid. We continue to expand our rollout of Alinity systems across multiple key markets, including the U.S., where last year we obtained FDA approval of Alinity for blood and plasma screening and have made significant progress obtaining regulatory approvals for a critical mass of our immunoassay and clinical chemistry test menu. I'll turn now to nutrition, where sales increased 6% in the quarter, led by strong growth across several countries and segments of our business, including Southeast Asia and Latin America, across both pediatric and adult nutrition, as well as above-market growth in the U.S. In pediatric nutrition, growth was driven by PediaSure, our nutrition solution to help kids grow and thrive, and Pedialyte, our oral rehydration product, which continues to see unprecedented uptake with both children and adults. In adult nutrition, global growth of 10%, in the fourth quarter was led by Ensure, our leading complete and balanced nutrition brand, and Glucerna, our leading brand for people with diabetes. Moving now to medical devices, where sales increased nearly 11.5% in the fourth quarter, led by double-digit growth in structural heart, diabetes care, electrophysiology, and heart failure. In structural heart, sales increased 17% in the fourth quarter, Over the last couple of years, our portfolio and long-term growth opportunities in this area have strengthened considerably. We've been building our position organically in this area for quite some time, when in 2017, the combination with St. Jude created what I now consider a best-in-class structural heart portfolio. MitraClip, our market-leading device for the minimally invasive treatment of mitral regurgitation, or leaky heart valve, is the cornerstone of our portfolio with annual sales this past year of nearly $700 million, growing 30%. Last year, we obtained an important new indication in the U.S. that significantly expands the number of people that can be treated with MitraClip. And just last week, we announced that we're initiating a clinical trial that offers the potential to expand the treatable patient population even further. Beyond MitraClip, several exciting technologies are expected to emerge from our structural heart pipeline in 2020, including CE mark approvals for TriClip, a first-of-its-kind technology to repair leaky tricuspid heart valves, and for Tendine, which targets replacement of the mitral valve, as well as U.S. approval of Portico for transcatheter aortic valve replacements. Turning now to diabetes care where sales increased nearly 35% in the quarter, led by Freestyle Libre, a revolutionary continuous glucose monitoring system. Several years back, we saw an opportunity to approach continuous glucose monitoring, or CGM, in a fundamentally different manner compared to others in the space. We challenged ourselves to rethink existing paradigms as we sought to develop a solution that would truly benefit the mass population of people living with diabetes around the world. That aspiration influenced every aspect of Libre, highly accurate, simple to use, particularly affordable, and easy for patients to access. The results of our unique approach have been remarkable by any measure. Libre has quickly become the global market-leading wearable CGM. Its user base has roughly doubled each year to its current level of approximately 2 million users globally, including the highest user base among CGMs in the U.S., Reimbursement coverage has ramped up quickly around the world as payers increasingly recognize its highly differentiated value proposition. And it's the only CGM that's widely available through the pharmacy channel, which is a significant benefit for patients as it simplifies the process of acquiring the product. In 2019, Libre achieved full-year sales approaching $2 billion, an increase of 70% versus the prior year. And importantly, as we planned for the substantial growth opportunity to come, we significantly expanded our manufacturing capacity to keep up with anticipated demand for this life-changing technology. Now I'll wrap up with established pharmaceuticals, or EPD, where sales increased 10% in the quarter, led by growth across several geographies in Latin America and Asia. For the full year, sales increased 7% for the second year in a row, as this business continues to execute its unique branded generic strategy in emerging markets. These markets are growing rapidly, their populations are aging, their middle classes are expanding, and healthcare spending is increasing due to improving access to healthcare. Our strategy to build significant presence and scale in these markets is unique and continues to result in strong growth. So in summary, this was another highly successful year with strong performance across our businesses. We continue to strengthen our leadership positions in some of the largest and fastest-growing areas in healthcare, and we're entering 2020 with great momentum across our businesses and targeting another year of strong organic sales growth and double-digit EPS growth. I'll now turn the call over to Brian to discuss our 2019 results and 2020 outlook in more detail. Brian? Thanks, Miles.
spk11: 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 8.5%. Exchange had an unfavorable year-over-year impact of 1.4% on fourth quarter sales. Regarding other aspects of the P&L, the adjusted gross margin ratio was 59.4% of sales. Adjusted R&D investment was 6.7% of sales. and adjusted SG&A expense was 28.3% of sales. The fourth quarter adjusted tax rate was 12.8%, lower than our previous four-year guidance of around 14.5%, due to continued implementation of and adaptation to the U.S. tax reform regulations. Our fourth quarter tax rate reflects the aggregate adjustment to achieve our full-year revised effective tax rate of 14%. Turning to our outlook for the full year 2020, today we issued guidance for adjusted earnings per share of $3.55 to $3.65. For the full year, we forecast organic sales growth of 7% to 8%. And based on current rates, we would expect exchange to have a negative impact of around one-half of 1% on our full-year reported sales. We forecast an adjusted gross margin ratio of around 59% of sales for the full year, which reflects underlying gross margin improvement across our businesses, offset by the impact of investments to support the rapid market adoption of our limited diagnostic systems, investments in Libre and MitraClip manufacturing capacity expansions, and the impact of currency mix. We forecast adjusted R&D investment of approximately 7% of sales an adjusted SG&A expense of around 29.5% of sales. We forecast net interest expense of around $515 million and non-operating income of around $200 million. Lastly, we forecast an adjusted tax rate of 13.5% to 14% for the full year 2020. Turning to our outlook for the first quarter, We forecast adjusted EPS of 69 to 71 cents, which reflects double-digit growth. We forecast organic sales growth of around 7 percent, and at current rates would expect exchange to have a negative impact of a little more than 1 percent on our first quarter reported sales. We forecast an adjusted gross margin ratio of somewhat above 58.5 percent of sales, adjusted R&D investment of somewhat above 7 percent of sales, an adjusted SG&A expense of around 32% of sales. Lastly, we forecast an interest expense of around $130 million in the first quarter. 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 to high single-digit growth for both the first quarter and the full year. In nutrition, we forecast growth of around 4% for the full year and growth of 3% to 4% for the first quarter. In diagnostics, we forecast mid to high single-digit growth for both the first quarter and full year. And in medical devices, we forecast double-digit growth, similar to last year, for both the first quarter and full year. With that, we will now open the call for questions.
spk05: Thank you. Ladies and gentlemen, if you have a question at this time, please press the star, then the number one key on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. For optimal sound quality, we ask that you please use your handset instead of your speakerphone when asking your question. And again, ladies and gentlemen, that star, then one to ask a question. And our first question comes from Bob Hopkins from Bank of America. Your line is open.
spk09: Oh, great. Thanks for taking the question. So I guess first, Miles, congratulations on such an incredible run of 20-plus years of value creation, obviously an incredibly impressive track record. And in light of that, the first question I'd love to ask both you and Robert to comment on a topic that I know is on the minds of most investors from a big picture perspective, and that is the durability of the incredible 7% revenue growth outlook that you guys have expressed for 2020 and beyond. And the main reason I want to ask that question is that when you take a step back, there is no other company in MedTech modeling anything close to that kind of growth off of that large of a base, especially for multiple years. So, Miles, for you, I guess just if you wouldn't mind providing some big picture thoughts on that durability topic. And then for Robert, maybe getting a little bit more specific on the product areas that give you the confidence long-term and and whether or not M&A or divestitures could play a slightly bigger role going forward to help you maintain that level of growth. Thank you.
spk02: Bob, this is Miles. The temptation to sort of say something that sticks my successor with just unbelievable goals for the future, et cetera, is overwhelming. So I'm going to speak first. You know, seriously, we have been building what we've got here for an extended period of time. It didn't just happen. It's not based on a single driving product or driving business. It's actually quite broad-based across all of our businesses. And while a lot of people have commented to me or us that, that, gee, you've got the law of big numbers and, you know, hard for a big company to grow, et cetera. We don't actually feel like that big a company. And we don't necessarily feel, even though we've got leading positions in so many of our businesses, we don't actually feel like the law of big numbers is working against us. We feel like the opportunity for growth, if you've got an innovative pipeline and you're in markets where there's a natural tailwind of growth demographically, or from an innovation standpoint and so on, I don't really think that this whole notion of, gee, our size or big numbers applies. You know, if we were a tech company, you wouldn't be asking us that because we'd be too small. So, you know, I think if we look at the size of the opportunities where we've placed the company and its businesses and the portfolio of products and geographies and so forth, I think there's enormous – market opportunity that's untapped, and I think there's enormous penetration to be tapped, and I think there's some obvious examples out there. And fortunately, in all of our businesses, I think every one of them is innovating and creating new products and innovating to replace older products in a way that's really never been true before, and it's across the board. As we look forward at that and model it, we think our growth rates are sustainable. How far out are they sustainable? I don't know, but years anyway. Are we going to have speed bumps? We're going to have speed bumps of our own making. We're going to have speed bumps from trade. We're going to have speed bumps from exchange. We're going to have speed bumps in any number of ways, as all companies have and do. And yet we have them now. And we're still growing at a very healthy, strong rate. And I credit the innovation pipeline, some smart acquisitions at the right time with the right businesses, the right strategies, the right fits. I credit the execution of our organization and the culture of execution that is here. I have super confidence in... my successor, no qualms. The minute you retire, everybody thinks you ought to diversify your holdings because you're too concentrated in one thing. I only wish I had more. I'll remind him every day that I'm a shareholder, which he knows. But I have nothing but confidence in the pipeline, the management, the products, the strategies, and the new leader who's going to take over for me. I have tremendous confidence in Robert, and he's got all the abilities, all the skills, et cetera. So, you know, we can keep talking about the law of big numbers and, gee, how do you grow on this base? You know, we don't feel slowed or anything by that. We feel like we've got tremendous opportunity to sustain our growth rates.
spk12: Yeah, Bob, this is Robert here. You know, as you're aware, you know, under Miles' leadership the last 20 plus years. You know, Abbott's been reshaped, you know, several times. I was close to him and to the board when we went to this last reshaping of the company to really position and align, you know, our businesses to kind of high growth markets, geographies, et cetera. And as Miles said, it wasn't just the acquisition piece of it, which was important, but it was also how we looked at our internal R&D, our internal innovation, how we thought about it. So, Obviously, with the transition here to CEO, you know, there's the natural question of the incoming, you know, do they think differently? Is there a change in strategy? Is it a different way of thinking? And I can tell you, I'm very much aligned with Miles. You know, we see things very similar. as it relates to our strategy, how we operate, the philosophy of the company, the vision we have for Abbott. And in the last 18 months, for me in particular, to be kind of close to Miles during this transition period, being closer to him with his mentorship and learning how he has been able to kind of create value, as you referenced in the beginning there, you know, that leaves me with my number one priority to do that is to really execute, as Miles said, on these organic growth opportunities we have. And we have multiple growth drivers, as you know, Bob, that, in my opinion, they're in their very early stages, you know, whether it's Libre, you know, the Alinity rollouts, our rejuvenated cardiovascular portfolio. I think we've got a great opportunity in our adult international nutrition business, our branded generic pharmaceutical business in the emerging markets, which is a very unique strategy. So I look at all of that and, you know, your question of how sustainable is this, I think all these opportunities are in the early stages here and it's really going to be up to me and the team here to make sure that we maximize on all of these opportunities. So we've got a portfolio that's aligned to, you know, the biggest areas of medical need, attractive geographies. As Miles said about the pipeline, it's a very rich pipeline. You know, we talk about how, you know, this pipeline has evolved and how we haven't seen as rich as a pipeline at Abbott in a long time. And it's a nice cadence also. It's not just a kind of one and done. We've got multiple kind of rollouts here. The way we operate is very strong. Miles talked about our culture. We set high aspirations for ourselves, and we do have a culture of accountability, of execution. And then you layer that in with 100,000 of colleagues around the world that are passionate. They care about what they're doing. They believe in what we're doing. They believe in our strategy. I think we've got all the elements here to be able to sustain this kind of growth rate going forward.
spk09: Great, that's super helpful. Just one super short follow-up on diabetes. Robert, if you wouldn't mind just giving us a quick update on Libre 2 timelines and your thoughts there, and then if you're willing to give us a sense for in your 2020 guidance, what sort of growth assumption are you making for Libre in 2020? Thank you.
spk12: Sure. So on Libre 2, specifically last October, I mentioned that we were working through a handful of issues. Quite frankly... we encounter this handful of issues and other parts of our business just too, so it's nothing that for us is terribly surprising. It's normal. I'm not going to go into any of the real specifics here, but what I will say, Bob, is that since that time in October, I'm very pleased with the progress that we've made, and I continue to be very confident in Libre 2 and its performance and the product itself and its ICGM label. So, Regarding the guidance on Libre 2, what I can tell you is that we've got a lot of growth. Our guidance contemplates a lot of Libre growth, so we're not necessarily differentiating here between 1 and 2. But if you look at our Q4, we had a great Q4 with Libre, and that's without Libre 2 in the U.S. It was a great way to exit and to enter 2020. As Miles said, we're the market leader in CGM, in revenue, and in the amount of patients, and we're growing at twice the rate. Our strategy here has always been, you know, Miles talked about challenging some of the paradigms. It has always been, from the moment we launched, to look at this as a more kind of consumer, retail, kind of web shop, online play here. So, When you look at our Q4, you don't see that kind of big Q4 spike and then drop in Q1, which you usually see from, you know, kind of medical benefit DME products. Our growth is very kind of consistent and sequential. The U.S. has done very well in the year. Obviously, we want to do better, but we exited the year with well over half a million patients in the U.S. You know, we set up some goals for for 2019 as it relates to distribution, payer coverage in the U.S., former positions, and we exited 2019 exactly where we wanted to be with all of those goals all favorable to Libre. So, Our focus in the U.S. in 2020 here is really to take advantage of what we've established in terms of the infrastructure and drive demand. So you'll see more TV advertising. You'll see more Salesforce expansion. You'll see more partnerships and execution of those partnerships. You'll see more sampling. And I think that that same momentum that you see in the U.S. is also there in our international markets, which is, you know, obviously a much larger base for us. And we saw great momentum in Q4. So our 2020 here is really focusing on international markets, is expanding Libre into geographies that we haven't yet launched. You know, we were capacity constrained in 2019, so there's several markets that we haven't launched and we've put in place now plans to roll Libre into those new geographies and roll out Libre 2 into, you know, some of those Libre 1 markets. You know, one thing I think is important to kind of put front and center here is the clinical aspect of Libre. You know, it is the most studied CGM right now. And if you look at the data, whether it's our data, whether it's real world evidence data, whether it's, you know, third party government sponsored trials, they all say the same thing, which is people that use Libre have better outcomes. They live better. Their A1C drops. Their hypo drops. Their rate of hospitalization goes down. So the value proposition that we've always envisioned for Libre, not only is it intact, but we actually see it growing. It's an easy-to-use, intuitive, consumer-friendly product that delivers the outcomes that are real and measurable, and it's priced for mass adoption. It's affordable. You know, we always saw the therapy benefit not only for type 1s and for pumpers. We saw this therapy benefit for people that were on one shot a day insulin, oral med patients. So we always looked at this market to be, you know, 80 to 100 million people. Now, is it going to penetrate all 100 million people? That might be a little bit too aspirational, but what I would say is that Is it more than two, three, five, ten million people? Absolutely. And that's how we're building our strategy, investing in the product, investing in the awareness, and investing in the scalability so we can capitalize on this opportunity. Thank you.
spk05: Thank you. And our next question comes from Robbie Marcus from J.P. Morgan. Your line is open. Thank you.
spk07: Thanks for taking the question. I'll echo Bob's sentiment. Miles, sorry to see you go, but we're very happy to have someone so confident as Robert step in. Maybe if we could turn to structural heart. I was wondering if you could give an update on where we are with reimbursement and MitraClip. And then also, a bit more broadly, Miles, you talked about some of the new product launches we're going to see in 2020. Maybe you could just walk us through those and the expectations throughout the year.
spk12: So I'll take that. On MitraClip, listen, we had a great quarter, had a great year. And as Miles said in his comments, about $700 million product growing at 30%. And, you know, the interesting thing here is that the penetration of the therapy is only at about 5%, right? So we see a long opportunity. I talked about MitraClip being a multi-year, multi-billion dollar opportunity here. And there's several elements to that. CMS reimbursement is an important building block. We expect that sometime in Q2. But I've always said that it was more than just a CMS reimbursement for the indication expansion we got. We know that We need to be able to penetrate the therapy. We need to open new centers, make it more available. To do that, we need to hire more reps, invest in, you know, field clinical teams to be able to, you know, to get that penetration. And we've also invested in a lot of clinical evidence and building clinical evidence here. We just recently announced our study to investigate MitraClip in moderate-risk surgical patients and So, again, we've been investing to build this market, and obviously MitraClip gets a lot of attention in the structural heart portfolio. But if I take a step back here, I think it's important that, you know, we look at, we've always seen valvular heart disease as a big opportunity for Abbott, you know, whether it's the demographics, whether it's the medical need. And we saw this unique opportunity with the St. Jude acquisition to put together our MitraClip capabilities with, the portfolio of St. Jude, and really create a standalone business unit that was best in class for Structural Heart. And we did that, and it's been about two years that we've done that. And I think we're seeing really the impact of the effect of a dedicated team, R&D, clinical, and we've got a nice cadence of products coming out this year as a result of that work. You know, we've got two new CEO approvals that we expect this year. Miles mentioned them, Triclip. This is a modified version of our MitraClip to treat the leaky heart valve. You know, we believe it's a big opportunity because therapy, if mitral therapy is low, you know, tricuspid leaky valve treatment or repair is even lower. So we know how to build this. We did it with mitral, and we're going to go about doing it the same way, you know, building the capabilities, the clinical evidence. Another big opportunity we have is with Tendine. You know, this will be the first minimally invasive mitral replacement valve. So if you think about our team right now, we've built a lot of competency on mitral repair, and now we're going to put in the hands of this team not only the opportunity to offer repair, but also a replacement solution that's minimally invasive. And I think there's a great opportunity for us in that space, too. You know, both those products are premium. enrolling here in the U.S., so we do plan to bring those to the U.S. On the aortic side, we've made investments on Portico. We knew that we needed to make some clinical and some R&D investments here to increase the competitiveness of the system. And, you know, we like the data. We think there's going to be a segment of the population, a segment of the market that we will be able to compete effectively. It's under FDA review, and we expect approval shortly. And then finally, on our structural interventions, this is a part of the portfolio that doesn't get a lot of attention here, but it's about a quarter of our structural heart business. It's growing double-digit. We've got great products there. We've seen a great ramp-up with our stroke prevention technology with PFO, our congenital business, and Amulet, which is right now under clinical evaluation in the U.S. for treatment of LAA soap. I took a step back here. I said, yeah, MitraClip is a big growth driver. We've got a lot of things going right there. We're making the right investments from a clinical, from a commercial perspective. But I look at the portfolio that's been built here, and I'm very excited. It's very complete. It's very differentiated. And there's a nice cadence, Robbie, to the launches.
spk07: Great. I appreciate that. And maybe just a quick follow-up. You know, Awinity still hasn't really started to launch in the U.S., yet you put up 13% growth in CoreLab in the fourth quarter. How should we be thinking about the impact in 2020 from Awinity both in the U.S. and outside the U.S.? ?
spk12: Yeah, I think that we're going to continue to see this kind of rollout of the Alinity platform. You know, the challenge we had a little bit in the U.S., and Miles talked about the progress we made, is that when we launched it in Europe, we had a more complete kind of assay menu, and that allowed us to, you know, with more intentionality go after the market, you know, existing accounts, new accounts. And in the U.S., we've now achieved, you know, let's say a critical mass of assay menu, test panel, et cetera, that allows us to have that same kind of intentionality we had in Europe, have that same intentionality move into the U.S. Q4, we did have some capital sales, so that brings up the growth rate a little bit. But I think you're going to see the same kind of growth rate in the U.S., the same kind of ramp-up that we saw in Europe.
spk07: Thanks a lot.
spk05: Thank you. And our next question comes from David Lewis from Morgan Stanley. Your line is open.
spk00: Good morning. I don't want to sound like a broken record, but I'll reiterate, Miles, there's some fairly significant and unique value creation over these last 20 years. So congratulations again on behalf of shareholders. Robert, Miles, just starting off with a couple of businesses that had lagged in 2019 that are actually showing some improvement here in the back half of 2019, which were neuromodulation and and CRM, some pretty decent improvements specifically in the fourth quarter. I wonder, Robert, you can just talk through, you know, what specific changes have been made in those two businesses and how you're thinking about the outlook or sustainability of those franchises into 2020. And then I'd have a quick follow-up. Sure.
spk12: So let's talk a little bit with Nero then. I mean, I think we had a tough year, full year in Nero. When we came into the year, you know, we talked about some of the challenges we were up against. And there were really two. We had, obviously, the Salesforce expansion and some of the disruption that that created, but we felt it was important to make that Salesforce expansion. And then some of the market declines that we saw. We'd kind of seen double-digit growths in the beginning of the year, kind of saw that go to flat and even negative growth rates. So I think the Salesforce expansion piece, we kind of got past that in the middle of the year. It's a unique selling model. About 30% to 35% of our sales team in the U.S. was new, was under a year or so. You know, we spent a lot of time, you know, getting them up to speed, not only with their territories, but, you know, how to go about, you know, the selling process, et cetera. And I think that's largely behind us. Now, obviously, if you look at the sales reps, the ones that have seven to ten years of experience, you know, they're much more productive than the ones that have got 12 months. But we're seeing a nice, steady ramp up in terms of the productivity of those new sales reps. And the other thing we talked about was how innovation and new product launches could kind of fuel the market growth. And I think you saw that in Q4, not only with us, but even with some of the other players in the market come out with new product launches, at least what I've seen now from some of the pre-announcements having kind of an impact there. And so we came out with our product launch, ProclaimXR, early in Q4, and I think you saw the impact of that in Q4. I think it was a modest improvement. We expect more, and a lot of our focus here in 2020 is going to be to ensure that this new sales team has got innovation to sell, so we're We're expanding our MRI portfolio. We know we need to do. We're launching a new radio frequency ablation generator. This is an important part of our customers' practices, and we felt that we weren't as competitive with our offering there, so we developed a new system that will be rolling out this year. And we also believe that programming and connectivity to devices, consumer devices, is an important aspect of patient adoption of the therapy. So we'll continue to work on how we integrate, you know, the implanted device into those more consumer products. So we've got a nice cadence of rollouts there. And on the CRM side, you know, we talked about this in the beginning of last year. We had, you know, we encountered some challenges and we felt that, you know, one of the things that we needed to do for the CRM side was is to make sure it got more focus and more attention, not only from me, obviously, but from the management team. So we made an organizational structure change, you know, Q1 of last year, which got finalized in Q2, where we separated the CRM business from the key business. And we didn't do it just from a field sales perspective. We did it, you know, really across all functions. So we have a dedicated CRM team. a business unit with a dedicated leader, R&D, et cetera. And I think you've seen some of the output of that focus in the second half of the year. I would like to see a couple more quarters strung together. So that's what we're aspiring here to. But I think one of the biggest impacts of that focus, obviously the field has an impact, but I'm more excited about the focus on the R&D side. I think we had kind of slowed down our R&D innovation over here, and that focus, that dedicated business unit focus, I think you'll see the output of that. Not only in 2020, we have a couple product launches in the U.S., a new ICD, and in Europe also, but we've got plans for a nice cadence of innovation in 21 and 22. So I'm excited about kind of what we've done there. Obviously, it's early innings in terms of this business you're going to be creating, but I like what I see.
spk00: Okay, and just two quick follows for me. Robert, on MitraClip, is there a specific embedded assumption in the guidance for MitraClip, and how acutely do you think we see that recovery in the back half? And then your margin guidance about 50 basis points is a little lower than 2019, consistent with our numbers. But if you could just highlight two or three of the examples of significant reinvestment for growth in 2020, that would be super helpful. Thanks so much.
spk12: So I just thought of your question about microclip recovering growth, and I think we've been pretty strong in our growth rate. The U.S. has done very well, and, you know, what we saw in the international market, if that's what you're referring to, we did see that kind of, you know, impact of the, you know, some of the studies that came out in Europe impact us in the first quarter, but every quarter, sequentially to that, we've seen improvement, and I think we've And we passed that on. Regarding the guidance, I mean, we've got a lot of growth. You know, as I said with Libra, we've got a lot of growth here. We've contemplated, you know, as I said, CMS approval. But I have been fairly consistent with this. CMS approval is going to be an important aspect here, but it's not just that, right? It's the, you know, we've been showing really strong growth in the U.S. even without the reimbursement, and that's a result of the investments that we've been making both from a field and clinical perspective. Sorry, what was the other question?
spk11: It was on margin expansion. You know, I'll start off by saying just margin improvement is an ongoing focus for us. David has been and will continue to be whether that's gross margin, whether that's the leverage we continue to get in SG&A. And yes, notably, we did see that this year. You may be off just a little bit from our model in the foreign currency mix. We have a little bit of a headwind next year, but We have gross margin expansion planned underlying. But keep in mind, as Robert said, with these investments that we're doing for growth, whether that's continued Libre expansion, whether it's the most recent MitraClip expansion we announced, as well as the unprecedented uptake of Alinity, that's presenting a little bit of a headwind. But that's a good news item in the short term. And longer term, you'll continue to see those gross margins expand as we look out over the years.
spk05: Great. Thanks so much. Thank you. Our next question comes from Vijay Kumar from Evercore. Your line is open.
spk01: Thanks, guys. Congrats on a really nice spring, Sarah. One may be on nutrition. The adult side is coming really strong. I know China has been a bit of a bother with some regulatory changes a couple of years ago. Could you comment on what you're seeing in China? Is adult nutrition back? Has something changed in China for you guys?
spk12: Well, listen, we achieved a pretty strong growth rate in Q4, and that's despite some of the softness that we did see in China. We talked a little bit about it in Q3, Vijay. You know, we've seen some improvement, but some of those dynamics are still there, you know, whether it's the birth rate or some of the kind of competitive intensity. We have, you know, obviously developed a plan here as we were going into Q4 and going into 2020 here. A big part of that strategy, you know, to address some of those competitive challenges dynamics there is innovation and product launches. And we put a plan together here. We've got a nice, steady stream of cadence of launches in China. But I do think that it does point out to the strength of our nutrition business that we're able to post this kind of growth rate despite still some continued softness in China. And I think that speaks to, you know, the strength of the business. You know, Myles talked about we had some very strong growth in Southeast Asia and Latin America. on both sides of the business, pediatric and adult. And, you know, I don't think that, I think it shows this, you know, China's an important market for us for sure. It has our attention, but, you know, we're not overly reliant on it.
spk01: That's helpful, Robert. And one on diagnostics. You know, I know flu has been the topic du jour. I'm just curious in what it means for diagnostics. You know, on the core lab side, validity, really strong trends, You spoke about continued share gains in Europe. I'm just curious where we are on the U.S. side. Is the wind rate on the U.S. side comparable to Europe, or is that something that we should be expecting for the back half heading into 2021?
spk12: As I said in Europe, I think we've had kind of good success in Europe. We've talked about winning new businesses at that 50% rate. The renewals of our existing business are retailing nearly all of that business. And I think in the U.S. right now, it might be a little bit too early just because we really didn't have the intentionality of the launch that we had in Europe. Now that we've got a more complete menu, I think our ability to compete and our competitive fitness, let's call it that way in the U.S., increases to the same level that we've had in Europe.
spk01: Great. Thank you, guys.
spk05: Thank you. And our next question comes from Larry Beagleson from Wells Fargo. Your line is open.
spk10: Good morning. Thanks for taking the question. Congrats on another really strong quarter. And Miles, I'll echo with the other comments and add that, you know, interacting with you on these calls, always insightful and fun. Just two quick questions. One, maybe for Robert on capital allocation. I know I've asked this on a few calls before, but, you know, you guys have paid down a lot of debt recently. Are you, Robert, maybe thinking about M&A a little bit differently? Should we expect more tuck-ins in 2020? And I just have one quick follow-up.
spk12: Sure. Sure. I think what you'll see is the same philosophy, the same framework that we've had for all these years, which is a very kind of balanced approach. As you've said, a lot of our focus the last couple of years has been to pay down debt. We've paid down close to $10 billion over the last two years. Our net debt to EBITDA ratio is around 1.5 now. And, you know, we've got kind of payments that are due in the next few years, and that's all kind of contemplated in our capital plan. The other thing we're always going to have a mindful eye here, Larry, is ensuring that a portion of that capital goes back to our shareholders. You know, our dividend is a big part of our identity. You know, we've increased our dividend for, 47 consecutive years. This year we just announced a 13% increase. and we announced also at the end of last year a share we purchased of about $3 billion. We do that from time to time, mainly to kind of offset dilution. We'll also look at our growth opportunities, and we've talked a lot about them, whether it's the rollout of Alinity, whether it's the manufacturing expansion of Libre, We just announced in Q4 a new manufacturing site, a second manufacturing site for MitraClip. You know, those are all great returns for our shareholders in terms of the return of that capital. And then on the M&A side, you know, we're not looking to do any deals right now. I think the framework that Miles has always worked is true to me, which is, you know, it needs to meet our threshold of it being strategic or, and at the same time opportunistic. And, you know, we've been looking at it a lot. We're always studying. We're always looking. And I haven't seen anything crossing the radar here that kind of falls into those two buckets. But, you know, we're always going to keep looking, as we've always done.
spk10: Perfect. And then just one housekeeping for Brian. And, Brian, congratulations on your retirement, and I'll miss you as well. Just FX on EPS, the impact in 2020. Thanks for taking the questions.
spk11: Paul, FX, it's around a nickel, Larry.
spk04: Thanks, Brian.
spk11: Based on the mix, you got it.
spk05: Thank you. And our next question comes from Rick Wise from Thiefel. Your line is open. Thank you.
spk08: Good morning, everybody. Maybe I'll start off with EPD. EPD, Robert's always a little bit of a black box to us medical device analysts, so I'll just say it to me. I won't drag everybody else into it. Clearly doing exceptionally well, strong fourth quarter, and you're saying mid to high single digits for 2020. But maybe just give us a little update, some of the key drivers. What could get you to the upper end of your range? And maybe some of the challenges, just give us some perspective about what you're thinking about for 2020.
spk12: Sure. You know, I've heard this comment a couple times now about kind of, you know, EPD or pharma business kind of being a black box or not as transparent and it's not as understanding. I mean, I will say here the biggest focus of this business is taking opportunity of the geographic dynamics, right? You know, you can either have a proprietary pharmaceutical business, a little bit more higher cost, versus a pure generic business, which is obviously, you know, very cheap. Our branded generic business kind of sits, you know, between those two bookends. I come from an emerging market, so I can tell you that when we buy medications, you know, it's not reimbursed. So you pay for it out of pocket. and you're willing to pay a little bit of a premium to ensure that what you're getting is high-quality product. And I think that that's what this business has been built on, is taking advantage of that dynamic of this population in these markets. growing with their disposable income and allocating some of that to their health care costs on brands that they trust. And that's what we've been building over these years. A key driver of this strategy here is you need to have the breadth and the depth in your therapy classes. So we have comprehensive portfolios in the geographies that we're competing in, They're deep in each therapy class. You need to be omnichannel. You need to be present in the doctor's office. You need to be present in the pharmacy. You need to be able to kind of communicate directly with the consumer. And you need to be local. You know, you need to have a local R&D engine organization and manufacturing to be able to move fast with the opportunities that you see. And I think that's at the core of our strategy. You know, one of the challenges in this business, as Miles has always said, is the FX piece of it, but the performance growth, you know, we expect it to be in this kind of high single-digit growth, and a big driver of that is being in the right markets, you know, with the right infrastructure, with the right products, with the depth, and the focus on execution.
spk08: Great. And turning to two other areas, you know, Heart failure business has done a great job. How sustainable is the robust growth we've seen? And, you know, maybe talk a little bit about the implications of the less invasive surgical approach for HeartMate 3, what that might mean. And just last, maybe touch a little bit on Aaliyah. It's been a little bit of a disappointment. What are next steps? Help us understand why. you know, what's going on and, you know, where we go from here with Allure. Thank you so much.
spk12: Sure. On heart failure, I mean, we had a very successful 2019. You know, we achieved the destination therapy indication for HeartMate 3 at the end of 18, so that rolled into 19. So you saw the growth rate of about 20% here, Rick. That growth is predominantly driven by share gains, and specifically here in the U.S., So we exited 2019. Our estimation right now is, you know, through our internal data, you know, north of 80%. So as we go into 2020, you know, we expect that to, you know, to not be at that 20% rate now and to mirror more of what the market is growing, which is, you know, we expect to be in that mid-single digit range. But I do believe that we've got a lot of opportunity. I talked about cadence of innovation in our products. And, you know, one product that's pretty quiet, but we've done a really good job there, I think it's CardioMEMS. CardioMEMS is now, you know, close to $100 million. It's growing 30%. We continue to enroll in our guide HF trial that's going to be used to open an NCD. But the outcomes there are also extremely, you know, extremely meaningful in terms of hospitalization reductions, et cetera. So I think that'll be kind of our next driver of growth in heart failure, and I'm very pleased with what the team has been able to build in that business. Going to your question on Aaliyah, you know, it's been a little bit of a, we'll call it like a mixed bag here. You know, we've had some businesses that we've brought into Abbott, and I think we've done very well with them. We've accelerated their performance. If I look at the infectious disease portfolio in our developed markets, that's done well. That's done very well. Yeah, of course, there's some opportunity there with the flu season, but I think the team has done a really good job here expanding the portfolio and looking at that install base beyond just a flu test. And our cardiometabolics business has done very well, too, growing in the high single digits, low double digits. So I think those two businesses we've done a really good job with, and I think the team has done a good job on the cost side, with the synergies too. But you have pointed out that there are some parts in the business here where we're not pleased with, we're not satisfied. Our emerging markets infectious disease segment had a tough 2019. Part of that is kind of NGO issues. purchasing cycles and dynamics in certain markets. But we've got to do better than that, and we've implemented a strategy here to really look at other emerging markets outside of the Afghan continent here and build the value proposition of those tests in other emerging markets. And our toxicology business, too, I don't think we've been able to kind of fully maximize the value there. And that one there has got a lot of attention, too. So, you know, we had a good Q4, a lot of focus here, a lot of good growth in the U.S. I think part of that was a little bit of the flu. But, you know, if we can get these two business here, our emerging markets and our toxicology business, to, you know, execute on the plans that we put in place for them, I think you'll see that as kind of a mid-growth opportunity. a mid-single-digit kind of growth business for us. But, you know, I look at the trend and the dynamics of these products and the opportunities we have. You know, the strategy to get into these businesses is still very much intact also. Miles talked about more and more testing moving to alternative channels. We continue to see that. And, you know, we're targeting steady improvement here. But I think the long-term growth opportunity because of that trend is very positive.
spk08: Thanks, and congratulations.
spk05: Thanks, operator. We'll take one more question. Thank you. And our final question comes from Kristen Stewart from Barclays. Your line is open.
spk06: Hi. Thanks so much for taking my question. Congratulations, Miles, on your retirement. And, Brian, I hope your next chapter is a positive one as well. Just, I guess, a couple of cleanup questions. In terms of... The, I guess, PHP product, I was just wondering if you can maybe update us on just the timelines there for expected launch and then also for AMULET as well, just kind of expectations for launch just to get some timelines. And then also I think you, Robert, had also mentioned just some – products within the CRM business launching there. Could you just maybe update us on expectations for that franchise? I think you mentioned a new ICD platform and some other milestones to expect within the CRM portfolio. Thanks.
spk12: So, sure. On PHP and Amulet, I mean, those are still, I'd say, a couple years away. So we're still in kind of clinical stages. evaluation of that. We'll then kind of put the information together, submit to the FDA. So I'd say you're kind of normal timelines over there. So you can look at it about a couple years away. You know, on the CRM side, you know, like I said, I think the biggest opportunity we had when we changed the structure was to kind of get the innovation going. So You know, we've got two product launches. We've got a new version of, you know, a new update to our implantable cardiac monitor plan for this year. We've got a new ICD plan, again, for both U.S. and Europe. And our growth expectations here are, you know, to be, you know, to do better than what we've been doing, you know, steady sequential improvement. You know, we've had some challenges, and I think that these products here will allow us to, you know, continue that sequential improvement here.
spk06: I was just going to say, and do you see any opportunities, I think Bob had mentioned this, but any opportunities just in terms of divestitures within medical devices or elsewhere within the portfolio or some smaller tuck-in? I know you said it didn't sound like you were going to do any larger scale M&A, but just more product lines to bring into the portfolio from more of a tuck-in acquisition from technology? Yes. earlier stage?
spk12: Yeah, listen, if I take that and just talk about, you know, our model, we have a diversified model. I fundamentally believe in our diversified model. I think you've seen sequential improvement in all four areas over the last couple of years, you know, from a big picture perspective. You know, now when you go into each one of them, can you find some areas that, you know, we can do better and we should do better? Yeah, we can, and we've talked about some of those But, you know, that doesn't mean that, you know, we don't think they're great opportunities. That just means that we need to focus on doing better and executing better on that. So as I look at, you know, these four businesses, I like the businesses we have.
spk06: Okay, perfect. Thank you very much.
spk02: Okay, this is Miles again. I'll wrap up and close for us. So first of all, thank you all very much for your very kind comments. And on behalf of both Brian and I, I'll speak and tell you that it's been a great honor and a great pleasure for us to lead our company. It's been a tremendous experience. I feel like I've had two or three careers here in the last 21 years and probably have. Brian was estimating this morning this was our 85th or 86th earnings call, and therefore I can't tell you that I know yet whether I'm going to miss them, but I sure have a lot of them. And, you know, they're always challenging. They're always interesting opportunities to converse with you about the prospects of the company and so forth. I feel like I leave the company in perhaps its best position ever in terms of products and growth, future opportunities, et cetera, as I said at the beginning. I'm very pleased with the succession and the management team that's here. It's not just the CEO. that's changing, the CFO is changing, and Bob Funk, who is a long-time Abbott employee and has been our controller for a number of years and been in some of the most challenging jobs at Abbott and so forth, will be an absolutely superb successor to Brian. You know that a lot of our management team has changed over the last couple of years as we move to a next generation of leaders and managers in the company, and that I think it's a great mix of people that are homegrown and also have come to us either through St. Jude or other outside places. And we're just really happy with the team we've got, the pipelines we've got, the positions we've got. We think our success is sustainable. And I think the track record that we've laid down over the last years has been recognized that way, and we're appreciative of the recognition that all of you have given it. As I commented tongue-in-cheek as a significant shareholder of the company, I'll obviously be watching closely, and especially, you know, in the immediate future as the chairman. So with that, we'll close the call. Thank you all very much, and thanks for all your support.
spk03: Very good. 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 a.m. Central Time today. on Abbott's investor relation website at abbottinvestor.com. Thank you for joining us today.
spk05: Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program. You may all disconnect. Everyone, have a wonderful day.
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