Becton, Dickinson and Company (BDX) Earnings Call Transcript & Summary

September 10, 2020

New York Stock Exchange US Health Care Health Care Equipment and Supplies conference_presentation 32 min

Earnings Call Speaker Segments

Larry Biegelsen

analyst
#1

We have Becton, Dickinson with us for this session. Joining us from the company are the President and CEO, Tom Polen; the CFO, Chris Reidy; and Kristen Stewart, the new Senior Vice President of Strategy and Investor Relations. I'm flattered that Kristen has made our conference, her first one. So in terms of format, this will be a 30-minute fireside chat. Tom, Chris and Kristen, welcome, and thanks for joining us.

Thomas Polen

executive
#2

Good morning, Larry.

Christopher Reidy

executive
#3

Good morning, Larry.

Larry Biegelsen

analyst
#4

Great. So Tom, let's start at a high level. Investors are clearly interested in the recovery from COVID, the testing opportunity, Alaris and the pipeline opportunities like below the knee. But I've been -- the other question I've been getting a lot recently is, is there a structural issue here because we've seen consensus estimates come down by a considerable amount for BD over the past few years. So my question is, Tom, how confident are you that you have the right strategy? And what do you think will drive future growth?

Thomas Polen

executive
#5

Yes. Yes, Larry, again, thanks for having us this morning. It's great to connect again. And certainly, for myself, coming into the role about 7 months ago, I'd recognize Street expectations and our guidance have come down over the last couple of years. And I get that, that can be frustrating for everyone. Foreign exchange had been a headwind for the company. We can't blame it all on FX, 100% get that. There are a number of other challenges in the base business, right? There are DCBs, industry-wide paclitaxel concerns. Thankfully, our broader BDI portfolio helped offset some of those pressures. Then there was the Alaris ship hold. And of course, COVID-19 hit the overall industry. So yes, there's been several headwinds. And I can -- what I can say is we've been very focused and steadfast in addressing these issues. I think the other thing is we're also taking action to strengthen our processes to both prevent and better identify any potential matters that may arise in the future. The other thing is we also see the opportunity to better communicate with the investment community. And I think you're seeing us and already start to take action on that. But to your specific question, we do not feel that there's any structural or fundamental issues at BD, right? We have a very clear strategy. We can talk about that more in a bit. We're making good progress overall on that strategy. We're executing well. And so looking forward, I know FY '21 and the long-term outlook is on everyone's mind. So maybe let me just spend a few moments to provide some high-level thoughts there, Larry, if that's okay.

Larry Biegelsen

analyst
#6

Sure.

Thomas Polen

executive
#7

If we look at -- looking ahead, first off, we think about that -- again, we're making good progress on that strategy. And we've been progressing the business, and operations are continuing to perform well in Q4. So for fiscal 2021, I'm not going to get any specific numbers or details right now. However, we recognize that it's a complex time in the industry. You've got a lot happening in the market with COVID. There's a lot of new COVID-related products that can be difficult to forecast. Overall, there's just a lot of moving pieces. And so let me break down just a couple of observations that I thought could be helpful for everyone that's watching here this morning. So first, as I've said, we're making good progress on executing our strategy and progressing our goals towards 3 goals: durable revenue growth of 5% plus on a normalized basis. The second goal, we've stated very clearly, is continuing to drive margin expansion, 10%-plus adjusted EPS growth. And the third is continuing to improve our balance sheet strength and flexibility going forward. And we're making good progress towards each of those goals. Second is, of course, we've got some exciting new product innovations, specifically the Veritor COVID assay comes to top of mind. It's something we're excited about. With that said, we recognize those types of products are pretty difficult to forecast in this environment. And we've noted that there's a wide range of Veritor estimates out there. There's some even in the $1.5 billion to $2 billion range, which seems aggressive to us given the range of variables around vaccine timing, overall testing supply versus demand over the length of 2021 and how ASPs can evolve over that point in time. And we can get more into Veritor later on. I think with that said, we remain very confident in our clinical performance. You've seen some recent -- an article published in that regard and the benefits. We continue to have very strong demand on Veritor, and our manufacturing ramp-up remains right on track. In line with our strategy, the other thing related to Veritor is we do plan to reinvest a portion of the Veritor and BD MAX COVID assay profits back into the business to drive our strategy of durable, long-term growth. So third maybe item to point out is that unlike many -- most other medtech companies, we do have a September fiscal year. And so we do not anniversary the COVID-19 headwinds until Q3 of FY '21, right? So the first half is going to be a tough compare. Taking this into account with other factors, I think it feels like some of the current Street models are more optimistic in areas specifically like MDS, for example, where we'd expect a little bit more modest growth. And then finally, infusion pumps, right, in MMS, of course, for Q1, we had a partial quarter before the ship hold, so that creates a bit more of a difficult comp. And then Q3 benefited from a bolus of medical necessity products in the U.S. and higher COVID-related sales in Europe. So hopefully, some of those comments are helpful as you think about FY '21. And maybe, Chris, I don't know if you have any other comments to add?

Christopher Reidy

executive
#8

Thanks. The only thing that I would say is that, as you think about some of the observations that Tom made around '21, it obviously flow through to your FY '22 models as well. So you get to do that. So I think…

Larry Biegelsen

analyst
#9

Chris, it's just a little hard to hear you. Just want to make sure everyone can hear you okay.

Christopher Reidy

executive
#10

Okay. I can repeat that. We're -- we've got a speaker in between us here.

Larry Biegelsen

analyst
#11

Yes, it may be worthwhile repeating it.

Christopher Reidy

executive
#12

Just bear in mind that the observations that Tom made will flow through to your FY '22 models as well as you model enough of it.

Larry Biegelsen

analyst
#13

Okay. Perfect. So last to unpack, Eric -- Tom, as you can imagine, maybe just on the COVID recovery. I recognize that a lot of companies don't like to give intra-quarter updates. But you gave some helpful color commentary on the fiscal Q3 call about what new trends you were seeing through, I believe, July. Any color you can share on how the recovery is progressing based on maybe some public data points that you're comfortable sharing with us today? And maybe the path to recovery, just to add on to that, kind of how you see the recovery progressing?

Christopher Reidy

executive
#14

Yes. I'll take a shot at that, Larry. And what I would say is that we did, in fact, give a lot of color on the monthly progress, and we gave a lot of granularity in the midst of the pandemic, and that was in the absence of quarterly guidance. In the beginning of August, we obviously gave full year guidance and the fact of the fourth quarter guidance. And so as a result, we don't think it's appropriate to comment any more about monthly performance now that we have that guidance. And as Tom opened the conversation with is that I would point in the short term to the fact that we feel good about the progress the company is making in our execution and performance, and I'll leave it with that.

Larry Biegelsen

analyst
#15

Okay. Perfect. So let's move on to COVID testing, which I think has been arguably the #1 topic for investors recently. Tom, you gave a lot of helpful color in your opening remarks. I mean it looks like we're going to have about 100 million tests available in September. That's what the government has said, and we're only doing maybe 20 million or so a month. So what are your thoughts on the testing, diagnostic testing, given the recent Abbott and Roche news with their own antigen tests?

Thomas Polen

executive
#16

Yes. Well, first off, as I said, we continue to have very strong demand for Veritor, and our manufacturing scale-up continues to be on track. And our R&D pipeline is also progressing well there, as we've talked about, work underway for a combined assay. We haven't given a time line for that, as we've shared, but it continues to progress in our pipeline. So as you think about new entrants, maybe just a comment, I would say is we're 100% supportive of more diagnostic tests coming into the marketplace. We do believe strongly that rapid antigen testing has an essential role in helping to combat COVID-19, right? And there needs to be more capacity coming in. And we do anticipate that more players will come into the marketplace and continue to do so over the next couple of months. So specifically, maybe to your question, I normally don't comment. I rarely, if ever, comment on any specific company's products. But maybe just at a macro level, what I can share is, first, we've been a leader in point-of-care respiratory testing for many years, decades. We're actually a pioneer on lateral flow technology. If you look at some of the early core patents, the [ Warfel ] patents that were in that space that were licensed, those were BD patents, right, that invented a lot of what is lateral flow technology. And the industry is, if we just step back at a high level, right, the industry, including BD, we started with manually read tests several decades ago and developed very purposely new chemistries for the assays and new instrument, the whole new generation of instruments that were meant to take assay performance to the next level. And we saw that play out, right, due to the performance benefits of those platforms and those chemistries, pretty much most respiratory infectious diseases, point-of-care testing moved to instrumented-based platforms because you've got higher. There are significant benefits on performance. And so we've always been a science and clinical evidence focused company. You saw that and how extensive and diverse our clinical trials were for the Veritor COVID-19 assay, a 21 different geographically diverse sites, routine care settings, outpatient clinics, drive-through clinic, skilled nursing facilities and we saw a very strong performance of Veritor in our clinical study. You've also seen us now start to generate what is the first comparative clinical evidence in this space. And I think you can expect we're going to continue to be focused on the science and more real-world clinical evidence going forward. And we remain very confident in the performance of Veritor in that situation.

Larry Biegelsen

analyst
#17

So that's helpful. I mean just to cut to the chase, you threw out some Street numbers that you, I think, you thought were too high for Veritor, maybe $2 billion or so. I mean I think you have, off the top of my head, about $3 billion in capacity total with Veritor and MAX in fiscal 2021. We used the kind of -- the ASPs you've provided. But the Street seems to be coming in at about $1 billion for Veritor, $300 million for MAX in fiscal 2021. Are you willing to kind of say, if you think those are, I guess, feel a little bit more realistic than some of the estimates you put out that you mentioned earlier?

Thomas Polen

executive
#18

Now I'll turn it to Chris.

Christopher Reidy

executive
#19

Yes. I think the takeaway, Larry, what Tom opened with is the fact that, obviously, forecasting is very difficult. It's a very dynamic environment. The point that we made is we felt that the Street consensus is very dispersed. And the point we wanted to make is we felt that those analysts -- we're not going to talk about specific analysts and specific models. We're not going to get into the details of numbers right yet, but we did want to make a point that the [ outer center ] of that $1.5 billion to $2 billion range or, in some cases, $2 billion plus, we think that that's a little too aggressive. And we think it would be more prudent, given the dynamics of the situation, to not be in that high level. And we just want to kind of give that indication.

Larry Biegelsen

analyst
#20

Chris, those numbers, was that Veritor only or your combined Veritor, MAX?

Christopher Reidy

executive
#21

Veritor only…

Thomas Polen

executive
#22

I'm sorry, Veritor…

Larry Biegelsen

analyst
#23

Veritor only. Okay. Sorry, there's a lag, and I keep speaking both here. I apologize. Veritor only, got it. Okay. All right. Any comments on the durability of testing? Do you think testing could be a longer-term opportunity even once vaccines hopefully come out?

Thomas Polen

executive
#24

Yes. And certainly, we're hopeful that vaccines are developed. We certainly -- I'll read the same on how they're progressing. And at the same time, we do believe that there will be some COVID-19 testing is likely to continue. Of course, at what level it's going to continue after the vaccine, but that gets highly speculative at this point for fiscal 2022, in particular. So I think what's probably fair to say is FY 2022, as a fair assumption, may not be at the same level as '21. Beyond that, I think it's premature to speculate.

Larry Biegelsen

analyst
#25

Yes. And I heard you say today, just want to make sure I heard it correctly, that we know the margins are quite attractive on the COVID testing. But it sounds like today, you'll consider reinvesting some of the potential upside from that. I heard -- did I hear you correctly on that earlier?

Thomas Polen

executive
#26

Yes, you did. And I think just -- maybe just to go back to our strategy and what I talked about. Our first pillar of our strategy, that durable 5%-plus, long-term growth element, part of that gets to also getting back to investing in R&D. And one of the areas that, for example, that we've recently done is established a growth fund, looking at reinvesting a portion of the profits from Veritor and MAX back into the business. And so I'd actually called up John DeFord, who I know you know well, our Chief Technology Officer for the company, and said, John, how do we invest these -- some of these incremental profits in the right way? And he came up with this growth fund program, which is very similar to what was done at Bard. And so we've got all the businesses across the company have actually submitted ideas, could be completely new product development opportunities, could be an unfunded line extension that has significant incremental revenue opportunities or it could be a commercial program to accelerate product adoption in a certain area. And so those submissions are actually all coming in right now. This week, they're actually all due. And we'll be making investments and trade-offs and putting investments behind those biggest opportunities. Of course, if you look back over the last 5 or 6 years, when we've been in an integration phase, right, of CareFusion and Bard, our R&D has been relatively flat. And so what I think you'll see is those investments reflected in R&D growth that's higher than what you've seen over the last 5 or 6 years and is in line with our strategy of driving that durable 5%-plus revenue growth as well.

Larry Biegelsen

analyst
#27

Okay. I'm sure John was thrilled to get that call from you. Some people look forward to hearing kind of the outcome of that exercise.

Thomas Polen

executive
#28

Or our segment presidents, yes.

Larry Biegelsen

analyst
#29

So let's -- Tom, let's touch on the Alaris pump. First question is, you've talked about waiting for FDA to sign off on the, what you call, summative testing protocol. Are you able to share with us if you've heard any back from the FDA?

Thomas Polen

executive
#30

Yes, certainly understand everyone's interest in the status of that. And as I've said time and time again, there's no higher priority in the company for myself and our leadership team than getting the 510(k) in, right, the right way, getting that submitted and getting Alaris, right, fully back to where it deserves to be in the marketplace. So we're not going to get into the practice of continuing to provide monthly updates on our actions and dialogue with the FDA, Larry. But what we noted in our earnings call, which was just a month ago, I think August 8 or so, we continue to feel good about the overall collaboration process that we're engaging with the FDA. Our team continues to execute well. And we'll keep you updated at the right cadence as we make further progress in key milestones.

Larry Biegelsen

analyst
#31

Tom, as you can imagine, people like an analyst talk to kind of industry observers, it's easy for people -- some people to make drug parallels with what happened to some other infusion pumps like Baxter's Colleague. So I guess my question for you is, why is kind of what happened with Colleague and I think there was one other one that was withdrawn from the market in the past 10 years, why are those not a good analog for the Alaris situation, i.e., what makes you confident that you'll be able to return this pump to market?

Thomas Polen

executive
#32

Yes. First off, we can't comment on what went on between FDA and Baxter with its Colleague pump and their specific situation. All I can comment on is our situation today as a stand-alone. And of course, as I said, resolving the Alaris situation is my and our entire leadership team's highest priority in the organization. And our focus is making sure that we get that submission in, in a timely way that the right submission that will enable a timely FDA review and clearance. And so as we said on our Q3 earnings call, we expect to submit the updated Alaris 510(k) in late fiscal Q2 '21 and/or early Q3. And again, as I said, our team is executing well on that. We're going to continue to keep you updated at the right cadence. And of course, we've been working collaboratively with the FDA to continue to provide Alaris pumps to our customers, right, throughout this COVID pandemic. And as I've shared in the past, we've shipped to over 1,000 hospitals over the last several months, and we continue to remain confident in the safety of the product overall. So that's…

Larry Biegelsen

analyst
#33

Understood. And I'm going to push my luck here. I keep asking about the new pump you've talked about. Any -- I guess I'm just curious when we're going to get visibility on the new pump because you have alluded to developing a new pump.

Thomas Polen

executive
#34

Yes. I'm only -- yes, first off, we appreciate your persistence, Larry. It's what makes you good. But we're not going to comment on that at this point in time. Let's stay focused on our submission on the 510(k), getting that back out, and we'll give the updates when it's appropriate.

Larry Biegelsen

analyst
#35

Okay. Before a couple of financial questions, I wanted to ask one more product-related question, which is Lutonix. And so 2 things. One is our checks suggest that drug-coated balloons, it's hard to tease out obviously with COVID. But they are -- the data continues to be favorable, the safety data, in general, for the category and that reinterventions are something that patients and physicians don't want, obviously, in this environment. So drug-coated balloons, drug-coated technology is coming back. A, would you agree? And b, maybe on the below-the-knee submission, I don't think we've seen a lot of the public data beyond the 12-month pivotal data that's been shared publicly. So it's hard for us to judge what the likelihood of success is or with FDA. So on those 2, on Lutonix, a, DCB is coming back for the reasons I mentioned? And b, BTK, anything you can share that would give us confidence that, that might be approved?

Thomas Polen

executive
#36

Yes. So again, great question. Just again, put in perspective, Lutonix overall represents less than 1% of our overall sales. So we get a lot of attention on it, but it is less than 1% of -- much bigger percentage when it was in Bard, much less within BD. With that said, right, in Q3, our fiscal Q3, we -- in our earnings call, we did share that we were seeing good momentum in DCBs overall. We're seeing good recovery. And that rebound was very consistent with what we had seen with elective returns overall in the business, elective procedure returns in the business. So I think that's a positive certainly for DCBs overall. When it comes to BTK, of course, we -- as we had shared, we are under an active review with the FDA, and we continue in an active review of BTK with the FDA. So I don't think it's probably appropriate for me to comment on that, but we will do so when the time is right.

Christopher Reidy

executive
#37

I would just add that the right assumption right now, Larry, is we're not assuming any revenue from BTK in our FY '21.

Larry Biegelsen

analyst
#38

That's very helpful. I don't know, Chris, I wanted to transition to financial questions, and I have some specific ones. Tom gave a lot of helpful color. I wanted to kind of keep it simple. But maybe I'll just cut to the chase. We see kind of people who have updated numbers, top line, people coming in maybe $18 billion, $7 billion to $19 billion. On EPS, we see people $12.25 to $12.50, some of the more recent models that have been updated, Chris. Without getting into too much of the specifics, can you react? Anything -- any -- do you think people are hearing the messages there? Or are people even -- some of those recent updates that are all coming in that range, people are still missing something?

Christopher Reidy

executive
#39

Yes. I would say, we're not going to react to specific models or give specific numbers at this stage. It's too dynamic and too early in the process. But I would say that what we were focused on is the fact that there seem to be good updates that are coming down. Folks are already listening to what we're saying, but not everybody. And so the point we made on Veritor that there are still a number of analysts that are influencing consensus because they're being well too optimistic in our view. And so I think we wanted to be clear on that. I think that's the other comments that we made is as we look at revenue, for example, we think folks are being a little bit more optimistic on MDS than we would be at this point and primarily because of the fact, I think, that we had a fiscal year of September. And as a result, we have 6 months or full half a year of the difficult compare against pre-COVID levels. And so we also think that it would be prudent to not assume that hospital utilization and, therefore, the impact on many of our businesses, including MDS, get back to 100% in the near future. So when you put those combinations together, we would expect more modest growth in MDS. The other thing we wanted to point out was in MMS, and that is because it's been very lumpy in FY '20. We had a partial quarter for ship hold with Alaris. And then we had a very large bolus of revenue in the third quarter from the U.S. medical necessity as well as in Europe with COVID-related buying. And so those are 2 headwinds that are going to be very difficult for payers as we move into '21 for MMS. And at this point, as we see it, we're now back to medical necessity for Alaris going forward at this point. So bear that in mind. But that's the color we wanted to give on for now.

Larry Biegelsen

analyst
#40

That's helpful. One more on a layer is when we look at kind of our model, other models, we don't see much catch-up. If you're off the market for, I don't know, 12 to 18 months or whatever, people aren't buying capital. Would you expect some catch-up in capital once you're back on the market?

Christopher Reidy

executive
#41

I think the issue there is that there's been a lot of catch-up, if you were, through medical necessity through the pandemic. And so I think that's having an impact of what you would naturally see. So that's kind of offsetting that. So to some extent, that's already happened, and we'll see where it goes from here.

Larry Biegelsen

analyst
#42

And Chris, FX, I mean I think we can all do the math, and I did it a week or 2 ago, so I don't have the latest numbers, but it looked like it may be a 150 basis point tailwind, and you guys have given helpful kind of rules of thumb on the earnings contribution. Any comment on -- is that directionally right? And is that kind of that 1% and $0.02 kind of rule of thumb, does that still hold?

Christopher Reidy

executive
#43

Yes. So a couple of comments there. I would say, back in August, we said that it was a modest tailwind FX. There's been some movement on the euro since then, which makes a little bit more of a tailwind, but it's too early to tell. We'll see when we get up to giving our full year guidance in November of where the euro is because there's been weakness in other currencies around the world compared to the dollar, too. So I think what's different is some of the rule of thumbs that we gave in the past were for a much smaller company, a lot less impact from those other currencies. And so it's become more complex, and I think we're looking at that. We'll give a lot more detail on that in November to let you know what we're seeing, how much is getting caught up in profit and inventory and that kind of thing. So it's a little premature to comment on that. The good news is that we had 600 basis points of headwinds from FX in 2019. Right now, it doesn't look like we have those kind of headwinds. So we'll be analyzing that as we go forward in the next couple of months.

Thomas Polen

executive
#44

It's been a long time since it's been neutral or a tailwind, which would be -- which is good, yes.

Larry Biegelsen

analyst
#45

I wanted to try to just sneak 2 questions in, in the 2 minutes we have left. One on, it's -- a little embarrassed to ask about fiscal 2022, but we all have models to update given the uncertainty, obviously, right now. But on fiscal 2020, you had an operating margin guidance of 26% to 27%. This was before the Alaris ship hold and before COVID. Now you have Project Recode. Is that -- and assuming you don't have a COVID headwind in fiscal 2022, can the margins -- is that the right way to think about the margins in '22 being at least kind of that 26 -- the operating margin, 26% to 27% if you had kind of pre-Alaris ship hold and pre-COVID?

Christopher Reidy

executive
#46

Yes. The way I would answer that, Larry, is we feel very good about our ability to drive 5-plus on the top and 10-plus on the bottom, and that's in a normal environment without a lot of lumpiness from pandemic, et cetera. So when we get back to that or on an underlying basis, we feel comfortable at the ability to drive that. Recode is a big part of that. Now if you think about 5 on the top -- 5-plus on the top and 10-plus on the bottom, our attach rate is about where it will be for a while, I would say. And as a result, we're going to drive most of that leverage from margin improvement. And we can usually drive 50 basis points year in, year out. We've been able to do much better than that over the last number of years, driven by synergies and continuous improvement. And what we've said through Recode is that the combination of 3 big companies doesn't finish in 3 years, and there's still a lot more opportunity to simplify the business and simplify our infrastructure. And that's a great opportunity for us because it not only drives margin, but it makes it simpler for people to do business with us, and it makes it simpler for people, our associates to get things done in the company. So we see a lot of opportunity in Recode to continue that margin driving and a lot of good work being done on that. So we feel very confident in the ability to drive that kind of leverage in the model in a normal environment.

Thomas Polen

executive
#47

Hey, Larry, maybe just 2 things related to that, just adding on to Chris' comments is just that, first off, we're really proud of the team on Recode because despite COVID, they've just continued to execute. So no change in our trajectory. Of course, we had talked about the $300 million in savings, right, over the time period we've discussed for Recode. That remains on track. We've been investing in Recode. We've been executing against Recode right on through the pandemic. So just to reinforce that, and that team has been doing really good work. I think to your '22 comment, right, the biggest wild card, I think, for us and probably most of our peers who are in the diagnostics space related to COVID, it gets to Veritor and MAX and what will be the overall demand for COVID-related diagnostics, be that molecular or rapid testing in '22. And that's -- as we think about '22, that's probably the biggest wildcard again, not just specific to BD, but anyone who's got solutions in that sector.

Christopher Reidy

executive
#48

We intend to be very transparent around that so that we can see that increment in '21, and then we'll be able to isolate that going into '22.

Larry Biegelsen

analyst
#49

Okay. Well, we've got a minute over here. But Tom, I wanted to give you the last word. So we can -- feel free to wrap up, and I really appreciate the time today, Tom, Chris and Kristen.

Thomas Polen

executive
#50

Yes. I'd certainly be cognizant of everyone's time. So we appreciate, obviously, the discussion this morning, always a great discussion, Larry. And I think, hopefully, we gave a little bit more color on '21 on some of the key points. We're heads down executing our strategy, making good progress against that, and we look forward to obviously continuing the discussions with a lot of the folks on this call through the rest of this afternoon. So thanks, Larry.

Christopher Reidy

executive
#51

Thank you.

Larry Biegelsen

analyst
#52

Thank you. Good luck for the rest of the year.

Thomas Polen

executive
#53

Thanks, everyone. Bye.

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