Teleflex Incorporated (TFX) Earnings Call Transcript & Summary

September 9, 2020

New York Stock Exchange US Health Care Health Care Equipment and Supplies conference_presentation 31 min

Earnings Call Speaker Segments

Operator

operator
#1

[Operator Instructions] Also please be advised that today's conference is being recorded. Thank you.

Shagun Singh Chadha

analyst
#2

Good afternoon, everyone, and welcome to the 2020 Wells Fargo Virtual Healthcare Conference. I'm Shagun Singh, part of the medical device team at Wells Fargo, and I'm pleased to have Teleflex on this call with us. Joining us from the company are Liam Kelly, President and CEO; Jake Elguicze, Treasurer and VP of Investor Relations; and John Hsu, Senior Director of Investor Relations. Thank you so much for joining us today.

Liam Kelly

executive
#3

Thank you for having us, Shagun. It's our pleasure to be here.

Shagun Singh Chadha

analyst
#4

Great. So let's begin with the discussion of COVID-19. Liam, the pandemic had a 20% impact to your sales in Q2, and the impact by business varied. The businesses that were most impacted by the pandemic recovered at a strong pace in Q2. So I would assume about 28%, by our math, a 28% of sales. Some recovered at a more modest pace, that's another 27%. Some saw trends worsened due to a lag effect like the OEM business, about 9% of sales. And then there were still others that saw higher demand. So that's about 36%, including your largest segment, Vascular Access. So just on a net basis, what trends are you seeing thus far in Q3 versus the 20% impact that you saw in Q2?

Liam Kelly

executive
#5

Yes. So the way we look at our business is very simple. 1/3 of our business has very little impact of COVID, 1/3 has a positive impact, which is largely our vascular and respiratory product portfolio and 1/3 has a negative impact which is really our interventional urology, UroLift business, our Interventional Access, our Surgical and our OEM business. And as we stated, Shagun, a few weeks ago, we were very pleased, quite frankly, with how quick our business snap back following the postponement of non-emergent procedures that began in mid-March and really lasted through much of May. Our quarter 2 results came in better than we expected internally right across our complete P&L. And while we don't want to get into too many intra-quarter specifics, these trends have continued to make progress as we've gone through the quarter. I mean, I think it's still reasonable to expect that Teleflex will report a negative as reported revenue growth rate in quarter 3 compared to the prior year, but I think going to be an improving trend. As we see in marketplace, procedures begin to come back, accelerate the comeback of these procedures. And I think we'll see an improving trend. And our expectation is that as we get into quarter 4, that improvement of that improving trend continues into the quarter 4, in line with what we saw in early July, where we saw a pretty notable, modest improvement in July right across the portfolio.

Shagun Singh Chadha

analyst
#6

Got it. Consensus is looking for about 4% decline in Q3, is that in the ballpark? Would that be reasonable?

Liam Kelly

executive
#7

So I think it's reasonable to consider a decline, but obviously, I don't want to talk about intra-quarter, it's difficult for us to make that. But directionally, it's reasonable.

Shagun Singh Chadha

analyst
#8

Okay. That's helpful. So Liam, you had previously indicated that if procedures start to come back and if there is a controlled second wave, Q4 should behave very much like the trend you saw in Q1 pre-pandemic. And I believe you did about 7.5% growth adjusted for M&A and 8.2% inclusive of it. That said, your commentary on the Q2 call was slightly more cautious. Do you think you can get to normalized growth in Q4? And what is that growth? Is it 6% to 7%, 7% to 8%? Is it something else?

Liam Kelly

executive
#9

So I think that as I look at our growth rate and if I try and look at our growth rate through the first half of the year and if I exclude the impact of COVID, I'm quite pleased with the result of our portfolio. We've been growing at approximately 8%. At the time of our 2Q earnings call, our caution was justified because now we've seen some spike in COVID cases in certain populated states, in particular, Florida, Texas and California. In regard to the 4Q question, the answer, unfortunately is, it depends. It depends on what we see at the end markets. It depends on the second wave, if that occurs. It depends if we see a decline in the number of new cases. And it also depends on how organized the hospital systems are. And it also depends if we have a vaccine that's being rolled out in the 4Q and we get consumer confidence in order for people to feel positive about coming back to the hospital. And I think to answer your question about what is the underlying growth? The underlying growth of our business is clearly demonstrated in the first half of the year with an 8% underlying growth. And we feel good about our underlying portfolio, but it is unprecedented times. And generally speaking, I think we feel much better about where we are now than obviously where we were back in April, in that time frame. But it does seem like a recovery to positive year-over-year growth levels for most medical device companies seems to be getting pushed from Q4 into potentially into 2021 when we get back to a more normalized level. But again, there's a lot of caveats there, Shagun. There's a lot of depends and there's a lot of uncertainty, which is obviously why many companies do not have guidance out there and Teleflex is no exception to that.

Shagun Singh Chadha

analyst
#10

I got it. But just given the current variables, given where they stand as of today, do you -- should we expect normalized growth year-end? Or are you guiding more to 2021, just directionally?

Liam Kelly

executive
#11

So we don't have any guidance. So it's difficult for me to give guidance, Shagun, to a year-end number. Now there are a few anomalies about Teleflex in the fourth quarter that the investment community should feel positive about. And in that regard, I think we -- if we manage the second wave well, then I think to answer your question directly, yes, we will be in positive growth in the fourth quarter. If it is not managed well, then we won't be. If there's a strong second wave, then we won't be. But if it is managed well, there's a good potential that we will get into some sort of normalcy. And Teleflex is a little bit unique in the fourth quarter in so far is that we have 2 additional billing days.

Shagun Singh Chadha

analyst
#12

Got it. So let's ask the audience what they think. Josh, if you could please put out the polling question. So when do you expect Teleflex to return to pre-COVID growth levels on an underlying basis? If everyone could please record their responses. By Q3 '20, by Q4, early first half of 2021, second half thereafter? [Voting]

Shagun Singh Chadha

analyst
#13

Josh, do we have the results? Okay. 66% believe will be the first half of 2021. Liam, what do you think?

Liam Kelly

executive
#14

So I think that the investment communities, crystal ball is equally as good as Liam Kelly's crystal ball, quite frankly. I mean, I have a lot of sympathy for the investment community because there's so much uncertainty out there and is very difficult. I think you had 66% in the first half. I think, as I'm looking at it today as most med-tech CEOs are looking at it today. That now seems more reasonable that we're going to get to more normalized levels in the first half of 2021. And I think investors are aligning to that based on your survey. I think that it is very dependent on the second wave as to when that occurs and when we get back to normalcy. What we're seeing in the marketplace today, and this is a broad statement and not specific to any business unit, but we're seeing procedures in that 90%, 95% and moving in a more positive direction, but we need that to get to the 100% back to where it was pre-COVID. And I do think that it's going to take until -- into 2021 for that to occur.

Shagun Singh Chadha

analyst
#15

Liam, any comments on new patient flow trends in Q3 and how that's shaking out?

Liam Kelly

executive
#16

Yes. So there's a mix of patients that are likely to get procedures done, and there are a smaller number that will look to delay their procedures. In a survey that we did with our Interventional Urology customers for the UroLift, 85% of patients would consider getting the procedure done in this calendar year with 15% postponing it. So I think that -- and confidence in that patient population would be reinforced by a vaccine being available and consider that this is a minimally invasive procedure. You don't wear a catheter, no sexual dysfunction. So clearly, it's one of those procedures that I would feel that patients should feel confident about. It's a 1-hour procedure. It can be done in all 3 sites of service. If you don't feel comfortable in the hospital, you can go to the ASC or the outpatient. And then on the more general population, based on conversations I'm having with hospital administrators and CEOs, we're encouraged that they seem to be building in surge capacity for the ICU. In case there is a second wave, they have protocols in place. They have identified how to manage the patients a little bit better. In the first wave, we were intubating these patients very early in their treatment, whereas now the wisdom seems to be to use high flow oxygen. And that limits the time to stay in the intensive care. So we need to see those elective procedures continue to ramp as we go through Q3 into Q4. And I would like to see additional capacity come into the system. Most likely, I think it will come in, in Q1 because there is a little bit of a backlog of procedures that have not been completed in Q2, that need to be caught up at some stage. So I would like to hope that, that will come in Q1 or Q2 next year.

Shagun Singh Chadha

analyst
#17

That's really helpful. Let's touch on the DOJ investigation, even though we understand that what you can say is probably limited at this time. So on the Q2 call, you said that the DOJ had opened an investigation under the civil False Claims Act with respect to NeoTract's operations broadly in addition to an ongoing customer investigation. What can you tell us with respect to the scope of the investigation? Is it limited to the time period before the acquisition? Or is it broader than that?

Liam Kelly

executive
#18

So yes, you're correct. Our subsidiary, NeoTract, which as we all know, is where the UroLift product is used to treat BPH. They received a civil investigation demand from the Department of Justice, and that was really seeking information as it related to a 1 specific patient. We obviously cooperated with the department, and we provided some information. We submitted some additional information to them in June. We met with them in July. And that's when they advised us that they were going to expand the investigation into NeoTract operations more broadly. We maintain the very strong policies and procedures, and we promote a very compliant way of doing business. We've been in business for 75 years. This is the first time we've ever had any involvement with the Department of Justice. And the current investigation is really focused on that 1 customer, and the Department of Justice has spent some time looking at one particular rebate program that we had in place in the early days of the UroLift product. The UroLift product was -- had reimbursement that would make the procedure a profitable procedure for a clinician, if they use 4 implants. But if it was medically necessary for demand because they had a large prostate to receive an additional 1 or 2 implants, that would not be covered under the Medicare and Medicaid reimbursement. So we put a rebate program in place to make sure the demand got what was medically necessary for them. And that rebate program was put in place in 2015, 2016, and it was completed in 2017, early 2018 because the CMS reimbursement for additional implants came into being. So that rebate program was, we believe, compliant to safe harbor and all legislation and hasn't been in effect since early 2018.

Shagun Singh Chadha

analyst
#19

That's really helpful. Liam, you did indicate on the prior call that you do not anticipate a commercial impact. But can you help us understand that a little bit more? What gives you the confidence around that, especially given that the investigation is in the initial stages, I think you gave some important data point in terms of the timing of the rebate program. But the outcomes can vary in terms of the time it takes to settle, the amount of payout. Perhaps how you sell the product, maybe you can comment on that and even how customers utilize it. So can you just help us understand or provide broader thoughts on how to best handicap the risk around this investigation?

Liam Kelly

executive
#20

Yes, Shagun. To be honest, it's quite difficult to handicap the risk. But generally, these investigations can take a couple of years to reach their conclusion. If they continue to move in that direction. And obviously, the amounts can vary from 0 to whatever in the millions, if a company is found to be doing anything inappropriate. We don't believe we've done anything inappropriate. And given how early it is in the investigation, we cannot provide much clarity on timing or potential resolution. I would expect that most of our communication over the next number of months will be focused on that single customer. And from a reimbursement standpoint, we are confident that our strategy remains intact. And also, I would ask the investment community to make note of the fact that the preliminary physician scheduled for 2021, keeps the rates in the office pretty much unchanged, while proposed rates in the ASC and the hospital are modestly increased and this is an annual review, and we've seen incremental increases in every time since it's been reviewed. And from a commercial standpoint, we continue to execute, I mean, against a tremendous addressable market. We've treated 200,000 men out of 12 million in the United States. And let's never lose sight of the fact this product improves outcomes for men. This product makes men's lives better. And this product allows men to live a full life with their BPH treatment and our symptom relief. And it does good in the community and in society, and it's got a bolus of clinical evidence to support it. Over a multiyear period, it's got great patient outcomes. And I think those are some of the gating factors that will be considered as we have our conversations with the authorities in relation to this product. This product is doing good for society. It's doing good for men. It's giving great clinical outcomes, and it's very well supported by both the clinician community and also by men themselves electing to have this procedure done.

Shagun Singh Chadha

analyst
#21

That's really helpful. So let's discuss UroLift DTC advertising initiative that you have in place, and it could be an area of upside because I don't believe it's fully accounted for in consensus estimates. But the national pilot DTC initiative kicked off earlier than expected in early July. And I think with respect to timing, you had indicated that it would take about 4 to 6 weeks for initial patients to be scheduled. So I believe we should have begun to see the impact probably in late August, September time frame. Just curious if you can share with us what you're seeing right now? Any metrics or what kind of enthusiasm is out there?

Liam Kelly

executive
#22

So I think there's a lot of enthusiasm out there for what we're trying to drive with our DTC program. As we look at it, I think, a very nice indicator occurred in the month of August. In the first time of the history of Google searches in the month of August, Google searches for UroLift were greater than those for TURP, which up to now has been seen as the golden standard for the treatment. We've continued to engage with our urologist community to make sure that they are prepared for patients as they come through our DoctorFinder so that they can get their treatment. I think we've seen very, very little of the DTC in our revenue, quite frankly, and we probably won't see it until very late Q3 as we get into Q4, because you have to bear in mind, we began in the middle of July. So you have to really consider that you're going to be into September by the time you get these patients scheduled. But we are very encouraged by what we see. We've had to ask our third-party call center to add additional labor in order to be able to manage the call volume that we saw getting through. And our coverage is obviously much greater than it was last year with our 18 regional DTC campaigns.

Shagun Singh Chadha

analyst
#23

I got it. And I guess I asked this question on the call, but our checks did indicate that the program could boost volumes by 20%, 25%. Directionally, is that a fair range? Is it conservative? Is it aggressive, just given that you have kicked off this initiative, where does that number track relative to what you've seen?

Liam Kelly

executive
#24

Yes. So it's difficult at this stage given that we've just begun the program to give you a clear indication under that. But what I would tell you is that from an impressions standpoint, if you look at the 18 regional DTC campaigns we did last year, we have a multiple -- our expectation is a multiple of 6, the total impressions relative to that same period a year ago from the nationwide DTC. And so far, the urologist community are very supportive of what we're doing. They like us making men aware of this condition because they know as well as we do, that less than 5% of men that have BPH are aware that the UroLift is an option for them.

Shagun Singh Chadha

analyst
#25

I got it. You said multiple of 6x, correct?

Liam Kelly

executive
#26

I did. 6x, yes.

Shagun Singh Chadha

analyst
#27

Okay. So let's discuss UroLift in a little bit more detail. I think UroLift sales were the hardest hit due to the pandemic, but also recovered meaningfully and it actually turned positive in July. So -- and this was despite the COVID resurgence that we saw. Any additional color on trends you're seeing in Q3, August and September?

Liam Kelly

executive
#28

So I would say that I don't want to get too much into intra-quarter trends, Shagun, as you can appreciate. But for sure, your numbers are correct. It was almost minus 80% in April, minus 30% in May, minus 8% in June and then turn positive as we got into July. And I think that, as we expected, was the type of return that we expected. When we say it turned green, there was -- I think it was Johnny Cash wrote a song about my homeland called Forty Shades of Green. So it wasn't emerald, Shagun, but it was green. And that's a positive trend for us. And I think now that we see that our doc training is also getting back to normal. And one side effect of the DTC campaign is we are now seeing more doctors contact us asking for training on the UroLift as they see patients present themselves. And they're asking the doctor, "Hey, why aren't you offering the UroLift to me? I've seen the Facebook ad. I've done my own research, and it seems to be a very good procedure. And I'm currently on drugs or not on anything, and I'm pretty miserable. So I want to get this procedure done." So the positive side of it also is that it's raising awareness with urologists that see the ad themselves are encouraged by their patients that come into their practice.

Shagun Singh Chadha

analyst
#29

But just based on what you said, it sounds like August and September trends are -- it's continuing to improve versus what you saw in July, is that fair?

Liam Kelly

executive
#30

So like I said, that it was green in July. And we would expect to see continuance in that as we get through August and September without getting into too many specifics of the quarter, Shagun.

Shagun Singh Chadha

analyst
#31

Okay. Sure. So Teleflex received FDA clearance for UroLift 2.0 in late July, and that was required for the Shonin submission. Have you made this submission? And should we expect the 60- to 90-day review period? And then when do you plan to have reimbursement, begin the soft launch? Any color on that?

Liam Kelly

executive
#32

Yes. So you're correct. We got the 510(k). And you're also correct, we needed that Shonin submission. We do anticipate submitting to the PMDA in this quarter. And it should take, again, 60 to 90 days. So we should have that approval early in '21 then we would anticipate getting reimbursement thereafter. So we would anticipate right now that Q3 2021, we should be in a position to have Shonin and to have the reimbursement for the product. Then we can begin with the key opinion leaders. We've already identified up to 10 key opinion leaders in the Japanese market. These are the largest BPH centers in the country. We've done some education with them. We've done some peer-to-peer with urologists from the United States. They are excited about the product coming to the marketplace. And they are the key people that will be assisting us in our post-market study that we need to do as part of that submission, and we'll begin to ramp up revenue in the latter half of 2021 in the Japanese market. And again, the Japanese market is a $2 billion market as compared to the U.S. market at $6 billion. And we will begin to build that market, as I said, in the latter half of 2021 and start generating revenue, which quite frankly, was not in our original long-range plan.

Shagun Singh Chadha

analyst
#33

I got it. If I could just ask one more question on UroLift for Q4 and without giving any specific numbers or guidance. But UroLift did track to about 38% year-over-year growth in Q1 pre-COVID. And then in Q2, it tracked to 44% growth, excluding COVID. And so that trend is well above your initial target of 25% growth in 2020, which obviously the guidance has been pulled since then, but it seems like you're tracking well ahead of that. So as the DTC campaign kicks in, in a more meaningful way in Q4, is there any directional guidance, not guidance, but can you help us directionally think about what normalization would look like? Would it be unfair to assume that you would do at least what you did in the first half on an underlying basis as you approach normalization?

Liam Kelly

executive
#34

So again, the growth rates for UroLift would have been ahead of our expectation, if it hasn't been for COVID. And even the 38% in the first quarter doesn't truly tell the true story of what was happening with the UroLift. It grew 47% in February. So it was ramping through January and February. We haven't provided quarterly or full year guidance. So I'm very limited as you've said in what I can say. But I can tell you that we are absolutely happy with the performance of the UroLift product ex COVID. And we're -- we always said it would be the fastest to recover. And as we get into 2022 -- into 2021, probably, the market dynamics don't change. BPH is still there. There's still 12 million men. We've only treated 200,000 of them, most of them in the United States. We have excellent IP with great reimbursement, with great clinical outcomes. Now we have this wildcard of our nationwide DTC that will obviously raise awareness among urologists and patients alike. We have the launch of the UroLift in Japan in the latter half of 2021. And then we'll expand into other markets. Later in '21, we should expand into France. In '22, we should develop places like Spain, Italy, Germany, Brazil, China. So we're really at the very early stages, even though the product did $300 million last year, we're still at the very, very early stages of making this a global product and addressing the 100 million men globally that suffer with this condition.

Shagun Singh Chadha

analyst
#35

Got it. Just shifting gears to MANTA. It looks like sales meaningfully picked up in Q2. What trends are you seeing thus far in Q3? And could you help us think a little bit about U.S. TAVR market penetration? Obviously, the goal was to do about 8% or so, let's say, 8% to 10% in year 1, let's say, 15% in year 2. Just how are you thinking about it given COVID and as we come out of it?

Liam Kelly

executive
#36

Yes. So if you take the $200 million to $300 million market and you take the midpoint of $250 million, we, in our plan, at the beginning of the year thought we'd penetrate 8% of that market. We had penetrated 4% the year previously. Through February, we were at a 6% penetration of that market. So clearly, 2 months in, we were well ahead of where we thought we would be. As we entered into COVID, the first month it declined nearly 40% for the following 2 -- the first month of the second quarter. And then through May and June, we saw a positive to 11%. We continue to get access to hospitals, and we continue to see the TAVR procedures come back. And that's where the majority of our cases were. Now TAVR procedures are still not back at 100% of where they were pre-COVID, but they are moving in that right direction. We are now getting access to hospitals to train physicians. We have converted accounts in the month of July. We've converted accounts in the month of August. We are getting more access for that products than the rest of our Interventional Cardiology portfolio because clinicians are excited about it. And as clinicians are trying to get more patients through the cath lab, and remember, they're socially distancing out in the waiting room, the fact that this product removes time in the cath lab would help them be more efficient in moving products through the cath lab. We're continuing to build the body of evidence. We have the MARVEL study underway. We're working through the early adopters, and we're driving utilization in existing accounts and the clinical outcomes are just outstanding on this. It reduces major complications by 70%. So I think that will also stand to the product. So again, we see this product ramping from a very negative impact that we saw in April, and we've seen it improve sequentially in the 2, 3 months after that.

Shagun Singh Chadha

analyst
#37

Got it. I think we have about a minute left. Liam, I was hoping you could touch on M&A. It's the #1 use of your cash, and you've called out certain focus areas, Interventional Access, surgery, men's health, emergency medicine, I think, OEM, you recently did a deal. I'm particularly interested in Interventional Access. What kind of focus or technology would differentiate your platforms there? Where do you see gaps?

Liam Kelly

executive
#38

Yes. So I think overall, our overall strategy is to find a technology that fits in an existing area of our business. Our underlying space and very strong IP, good margin growth, strong clinical evidence and very strong IP. Those are a few of the things we look for. If we look at Interventional Radiology, Interventional Cardiology or even the aligned space of interventional neurology where you're basically using a similar platform, but it's just a smaller diameter and also allows for some synergies across the board. I think those areas are always of interest to us. There are some very exciting technologies that can quickly ramp, get adoption. And of course, it's a space where there's significant innovation year-over-year, and there is an opportunity for products to get into that, call it, $40 million, $50 million, $60 million in revenue with an innovative technology. And these are the needle movers for Teleflex. The larger players are probably not that interested in these technologies because it won't move the needle for them. And I think that's where Teleflex is pretty unique. And rest assured, our continued focus on M&A has continued pre, during and post-COVID and with a balance sheet of 2.6x leverage. We have capacity and firepower if we can find the right asset to bring into the Teleflex family.

Shagun Singh Chadha

analyst
#39

That's really helpful. I think that's all we have time for. So thank you so much for joining us. Appreciate it.

Liam Kelly

executive
#40

Thank you, Shagun. Always nice to talk to you.

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