Teleflex Incorporated (TFX)
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Earnings Call: Q1 2021

Apr 29, 2021

Speaker 1

Good day and thank you for standing by. I would like to welcome you to the Teleflex Incorporated 2021 Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer I would now like to hand the conference over to your speaker today, Jake Eligouise, Treasurer and Vice President of Investor Relations, please go ahead, sir.

Speaker 2

Good morning, everyone, and welcome to the Teleflex Incorporated First Quarter 2021 Earnings Conference Call. The press release and slides to accompany this call are available on our website at www.teleflex.com. As a reminder, this call will be available on our website and a replay will be available by dialing 800-585-8367 Or for international calls, 416-621-4642, passcode 6, 194,7 Participating on today's call are Liam Kelly, Chairman, President and Chief Executive Officer And Thomas Powell, Executive Vice President and Chief Financial Officer. Liam and Tom will provide prepared remarks and then we'll open up the call to Q and A. Before we begin, I'd like to remind you that some of the matters discussed in the conference call will contain forward looking statements Regarding future events as outlined in our slides, we wish to caution you that such statements are in fact forward looking in nature are subject to risks and uncertainties and actual events or results may differ materially.

The factors that could cause actual results or events to differ materially include, But are not limited to factors referenced in our press release today as well as our filings with the SEC, including our Form 10 ks, which can be accessed on our website. During this conference call, you will hear management make statements regarding intra quarter business performance. Management is providing the commentary To provide the investment community with additional insights concerning trends and these disclosures may not occur in subsequent quarters. With that, I'd like to now turn the call over to Liam.

Speaker 3

Thank you, Jake, and good morning, everyone. It's a pleasure to speak with you We are delighted with our Q1 performance, which exceeded the expectations we provided To the investment community on our Q4 call in February and reflected improvements in underlying revenue trends for the product categories Most impacted by the postponement of deferrable procedures, most notably interventional urology, interventional access and surgical. Quarter 1 revenue was $633,900,000 which was down 2.6% as compared to the prior year period on a constant Quarter of 2021 as compared to the Q1 of 2020, quarter 1 constant currency growth was modestly positive at Approximately 0.1%, which marks the 3rd consecutive quarter of improving growth rates and a return to days constant currency growth for the first time since the beginning of the COVID pandemic in the Q2 of 2020. From an earnings per share perspective, our adjusted earnings per share of $2.87 also significantly exceeded expectations we provided to The Street. This reflects the recovery we saw in monthly procedures as we moved throughout the quarter, Coupled with prudent operating expense management.

Lastly, during the Q1 of 2021, we committed to a new restructuring And continue to execute on new opportunities to improve the efficiency and cost effectiveness of our business. Turning now to a more detailed review of our Q1 results. As I mentioned, Quarter 1 revenue declined 2.6% on a constant currency basis. The decline in revenue was primarily due to lingering COVID-nineteen headwinds, Coupled with the impact of 2 fewer setting days in the quarter compared to the prior year period. When adjusting for setting days, we have experienced Day sales adjusted contributions from vascular, anesthesia, surgical and interventional urology offset by declines in interventional OEM and Other segment, from a margin perspective, we generated adjusted gross and operating margins of 59.4% And 27.5 percent, respectively.

This translated into a year over year increase of 210 basis points at the gross margin line And 190 basis points at the operating margin line. We were encouraged by our growth in operating margin performance, which demonstrated The ability of our business to generate significant leverage despite the impacts of lingering COVID headwinds On our revenue line, in fact, we continue to show significant leverage across the P and L as we generated the highest Adjusted gross and operating margins since becoming a pure play medical device company. Quarter 1 adjusted earnings per share was 2 point $0.87 up 5.5 percent year over year and well ahead of the expectations we provided the freeze on our quarter 4 call. Overall, I am very happy with our Q1 financial performance, which demonstrates the resiliency of the diversified global product portfolio that we have built, While also reflecting progress towards our longer term margin aspirations. Turning now to a deeper look at revenue results.

I will begin with a review of our reportable segment revenues and unless otherwise noted, The growth rates I would refer to are on a constant currency basis. The Americas delivered revenues of 375 point $5,000,000 in the Q1, which represents growth of 4.7% or 8.3% on a day sales adjusted basis. Growth in the quarter was driven by strength in vascular, anesthesia, surgical and interventional urology on a days adjusted basis. EMEA reported revenues of $141,200,000 representing a 16.9% decline As the prior year period saw a bolus of ordering ahead of the initial COVID surge As well as a higher level of COVID related restrictions and elective procedure deferrals that occurred during the Q1 of 2021. Turning to Asia.

Revenues totaled $63,700,000 which represents 10.3% growth With no selling day impact in this region. Importantly, we saw solid double digit recovery in China along with double digit growth in India and Korea. This more than offset declines in Japan and Australia. As we anticipated, the Americas and Asia continue to recover more quickly than Europe. And lastly, Our OEM business reported revenues of $53,500,000 which represents a 17.1% decline on a constant currency basis or 16.3% decline adjusted for selling days.

As anticipated, our OEM business continues To see a lagged impact related to COVID recovery, investors familiar with Teleflex would be aware that our OEM business device companies with complex catheters and surgical sutures and the Q1 impact reflects reduced orders from these customers whose Business is tied to non emergent procedures. As it relates to the acquisition of HPC, we are pleased that the integration has been And we have additional capacity coming online over the next 2 months, which should help drive growth in the second half of the year. Let's now move to a discussion of our revenues by global product category. Consistent with my prior comments regarding our reportable segments, Commentary on global product category growth will also be on a constant currency basis with color provided for selling day adjustments as well. Starting with Vascular Access.

Quarter 1 revenue increased by 5.8 percent to $164,000,000 or 9.3 adjusted for selling days as we had strong contributions from central venous catheters, EZIO and PIC product lines. Moving to Interventional Access. 1st quarter revenue was $96,200,000 which is lower than the prior year by 6 4%. When adjusting for selling days, the year over year decline was 3.8%. The decrease was largely due to the delay in the recovery of certain non emergent procedures due to COVID.

The decline Was somewhat offset by increases in Manta large boreclosure revenue, which grew approximately 30% globally adjusted for Turning to anesthesia. Quarter 1 revenue was $84,900,000 Which represents growth of 7% or 9.9% adjusted for selling days. The revenue growth was due to solid performance of ZMedica, which performed better than anticipated, partly offset by lower Shifting to surgical. Revenue was $80,400,000 Representing 2.3% growth or 4.7% adjusted for selling days, driven by sales of our polymer ligation clips and instruments, Partly offset by chest drainage and metal ligation decline. Now to Interventional Urology.

Quarter one revenue was $73,400,000 which was a decline of 1.3%. When adjusting selling days, the UroLift product grew approximately 1.9%. During the quarter, we continued to see canceled procedures negatively impact growth As COVID case counts surged in January February. However, as the quarter progressed, we were very encouraged by the strong double digit growth That occurred in March. The strong growth trends that occurred for UroLift in March continued during April as we continued to see improvements In our average daily sales trend, importantly, our average daily sales in April were for the first time Back to pre COVID daily rates on a consistent basis.

We continue to view UroLift as one of the first procedures to be performed as Environment is starting to improve again. We also trained 115 new urologists in quarter 1 And are well on track to achieving our annual target of training between 4 505 100 new urologists During 2021. And finally, our other category, which consists of our respiratory and neurology care products declined by 15 3% or 12.6 percent adjusted for selling days, totaling $81,700,000 The decline reflects headwinds to elective procedures as well as difficult comps from the prior year related to COVID ordering in EMEA. That completes my comments on quarter 1 revenue performance. Turning to some clinical and commercial updates.

I wanted to provide an update on our direct to consumer efforts for UroLift. On the strength of a successful 2020 campaign where we doubled awareness for UroLift in the targeted population of men with BPH and As planned, we have decided to increase our investment in 2021 and run a national campaign for the full year. With social media campaigns to augment the overall impact, we continue to view DTC as a multiyear catalyst For UroLift in the United States, as we are still in the early innings of market adoption and patient awareness. Indeed, UroLift is leading the way in BPH and this is the first time in recent years that a continue to make progress with our controls launch and we remain on track for a more fulsome rollout beginning in the second half of twenty twenty one. We remain confident that convergence to the UroLift 2 will continue over time and we continue to expect Generate significant margin expansion as the revenue base is fully converted.

As it relates to the UroLift ATC device, The launch continues to go very well as we've completed multiple case days and urologists find the use of the device to be intuitive We remain on track for a reimbursement decision in 2021 and view the approximate $2,000,000,000 addressable market as an incremental growth Driver that will be a positive catalyst for the foreseeable future. And we continue to work towards commercialization in France. We anticipate performing Our first cases during the Q2. With multiple catalysts in place across key geographies, including the U. S.

And Japan, we remain Confident that Duralit will become our robust global franchise, addressing a significant multibillion dollar opportunity. Lastly, before turning the call over to Tom, I would like to provide clinical updates highlighting 2 recent published studies with our Interventional Access Business Unit. The MARVEL Real World Study was recently published in December of 2020. This study tracked 500 patients across 10 centers globally who underwent transdermal large bore percutaneous procedures. Primary endpoints of time to hemostasis was a median of 50 seconds, While the primary endpoint of the major vascular complication rate related to the MANTA access site was in line with the SAVE MANTA IDE pivotal trial.

The study concluded that Manta was a safe and effective device for large bore access closure under real world conditions. In addition to the registry study I just highlighted, a separate meta analysis was published in February of 2021. This pool analysis examines data for nearly 900 patients, drawing from the CE The EMARQ and SAFE pivotal trial as well as the MARVEL registry study, key findings included a high technical success rate, Rapid hemostasis and low complication rates. In this study, median time to hemostasis was 31 seconds. Overall, we continue to invest in clinical and commercial catalysts that will help to sustain our upper single digit revenue growth That completes my prepared remarks.

Now I would like to turn the call over Tom for a more detailed review of our

Speaker 4

Q1 financial results. Tom? Thanks, Liam, and good morning, everyone. Given the previous discussion of the company's revenue performance, I'll begin at the gross profit line. For the quarter, adjusted gross margin was The highest since Teleflex became a pure play medical device company, totaling 59.4% or an increase of 10 basis points versus the prior year period.

The increase in gross margin was primarily attributable to product Mix, M and A and restructuring benefits, which were partially offset by foreign exchange headwinds. Similarly, 1st quarter adjusted operating margin of 27.5 percent was also the highest since Teleflex became a pure play mental device company And represented an increase of 190 basis points versus the prior year period. The increase was driven largely by the gross margin improvement, Partially offset by normalization of compensation expense accruals. Continuing down the P and L. For the quarter, Net interest expense totaled $16,100,000 which is a slight increase from $14,900,000 in the prior year period, Reflecting higher average debt outstanding.

Post quarter close, we issued a notice of redemption to holders of our Standing $400,000,000 aggregate principal amount of 4.7eight percent senior notes due in 2026. We plan to fund the redemption using available borrowings under our revolving credit agreement. Moving to taxes. For the Q1, our adjusted tax rate was 13.9%, which is up 140 basis points as compared to the prior year period. The year over year increase in our adjusted tax rate primarily due to less benefit from stock based compensation as compared to the prior year period.

At the bottom line, 1st quarter adjusted earnings per share increased 5.5 percent to 2 point Now I'd like to highlight another restructuring program that we recently announced. During the Q1 of 2021, we committed to a restructuring plan designed to streamline various business functions. We estimate that we will incur aggregate pre tax restructuring charges between $7,000,000 $9,000,000 Consisting primarily of termination benefits and between $3,000,000 $4,000,000 in restructuring related charges. We expect to begin realizing plan related savings in 2021 with total annual pretax savings of between $13,000,000 $16,000,000 Once the plan is fully implemented. To summarize all of our ongoing restructuring and cost saving programs, The total remaining pre tax savings across all current active programs are expected to be between $53,000,000 67,000,000 Further details of the programs are available in the appendix to the earnings presentation.

Approximately half of the remaining savings Our expected to be realized during 2021 2022 with the bulk realized by 2024. As such, we have good line of sight to non revenue dependent margin expansion for the foreseeable future. Turning to select balance sheet and cash flow highlights. For the Q1 of 2021, cash flow from operations totaled $110,800,000 as compared to $11,500,000 net use of cash in the prior year period or a year over year increase of 122,300,000 The year over year increase was driven by lower contingent consideration payments, lower payroll and benefit related payments At the end of the Q1, our cash balance was $324,600,000 And during the quarter, we paid down $100,000,000 in debt and our net leverage At quarter end, it was approximately 2.9 times. Subsequent to quarter end, we repaid an additional $25,000,000 in revolver borrowings.

Moving on to guidance. Starting with our revenue expectation for 2021, we now expect constant currency revenue growth Between 8.5% 9.75% as compared to 2020. This compares to our initial guidance, which call for constant currency revenue growth of 8% 9.5%. The increase in guidance reflects our confidence in the business, including first quarter results, which were better than we anticipated. We expect our interventional urology, interventional, surgical and anesthesia product offerings to be key contributors to our constant currency revenue growth during 2021.

Additionally, we continue to expect our interventional urology business will increase at least 30% Over 2020 levels. The midpoint of our constant currency guidance range also assumes approximately 2.5 Contribution from the acquisition of Zimedica. Turning to currency. We continue to expect foreign exchange rates Will be a tailwind to revenue growth of approximately 2%. And as a result, we now expect our as reported revenue to increase between 10.5 And 11.75 percent over 2020.

This would equate to a dollar range of between 2,804,000,000 And $2,835,000,000 Turning next to gross margin. During 2021, we now adjusted gross margin to increase between 155 and 255 basis points to a range of between 58 in a quarter And 59 in the quarter, and this is an increase of 25 basis points versus our prior forecast. We expect gross margin expansion to be driven primarily by a favorable mix of high margin products, including interventional urology, interventional access and surgical. Also contributing are benefits from manufacturing productivity improvement programs, benefits from previously announced footprint restructuring programs And the acquisition of Zmedica. Year over year gross margin expansion is expected to be somewhat offset by inflation.

Turning to adjusted operating margin. We continue to expect that adjusted operating margin will increase between 110 basis points and 2 10 basis points a range of between 26% 27%. The increase in adjusted operating margin will largely come from the gross margin line, Partially offset by normalization of spending associated with items including management compensation, commissions, targeted headcount additions And the potential for further strategic investments in support of key growth drivers such as UroLift and Nanta. Continuing down the P and L, we now expect interest expense to range between $61,000,000 $63,000,000 This compares to our initial guide, which called for interest expense of between $63,000,000 $65,000,000 The reduction in interest expense It's primarily due to faster than originally anticipated debt reductions coupled with lower than expected LIBOR rates. The early retirement of 2026 notes was always part of our full year interest expense assumptions.

Moving to taxes. We now expect our adjusted rate will be in the range of between 13% 13.5% or a 50 basis point reduction versus our prior guidance. Considering all of these elements, we are pleased to be able to raise our adjusted EPS outlook to between $12.65 And $12.85 or an expected increase of between 18.6% 20.4%. Lastly, while it is not our normal practice to provide quarterly financial guidance, given the ongoing situation with COVID, I would like to provide some color regarding what we expect to occur in the Q2 of the year. At the midpoint of our new guidance ranges, During the Q2 of 2021, we expect to realize approximately 24.5% of full year reported revenue Approximately 22.5 percent of our full year adjusted earnings per share, our outlook is predicated on the assumption that COVID will continue to cause disruption during the first half of the year.

That concludes my prepared remarks. I would like to turn the call back to Liam for closing commentary. Liam? William?

Speaker 3

Thank you, Tom. In closing, I will highlight our key our 3 key takeaways from the quarter. First, we delivered a strong Q1 with top and bottom line performance better than our expectation. 2nd, we announced another restructuring program that reflects our organizational efforts for continuous improvement. This action also contributes to our confidence in long term margin expansion efforts.

And third, we raised our revenue and adjusted earnings per share guidance, Reflecting a strong quarter 1 and our outlook for the remainder of the year. I would like to finish by thanking the entire Teleflex team around the world who have worked Tirelessly through the pandemic. As we begin to come out the other side of COVID, we will continue to meet our commitments To our patients, clinicians, communities and of course, our shareholders. That concludes my prepared remarks. Now I'd like to turn the call back to the operator for Q and A.

Speaker 1

We'll pause for just a moment to compile the Q and A roster. And your first question comes from the line of Richard Newitter with SVB Leerink.

Speaker 5

Thanks for the color on the trends on your O'Lift. Maybe just to start off there. So you mentioned that you've returned to pre COVID UroLift Interventional Urology Growth Levels. I'm just curious, is that you had different growth rates in the first half of twenty twenty, 40% and then it rose to 50% and in the Q1 of 2020, it was about 20%. Which kind of of those growth trajectories should we use as a reference point for the early trends that you're citing here in 2Q?

Speaker 3

Yes, Harish, thank you very much for the question. So we are quoting the trends in 2020 On a days adjusted basis in Q1 2020, even with the impact of COVID in the last Few days of or the last week of March, we grew approximately 26% plus in the Prior year. So we are very encouraged by the trends that we saw in the month of April. So at different times through the impact of COVID as we got into November last year, Rich, we did see days that we got back to a pre COVID level on an average daily sales basis, But we have not seen the consistency where it remains for a sequential number of weeks until the month of April and that is very, very encouraging to us. And I will say and the other data point I think is worth looking at is if you compare UroLift growth In this Q1 of 2021 and you compare that back to Q1 of 2019, That is approximately 30%.

So we're very pleased to be able to reiterate our full year Expectation for UroLift up plus 30% growth and the trends that we've seen in the last few weeks of March, But more importantly, in the 1st few weeks of April, have given us the confidence that we will definitely be able to reiterate that long term or that full year guidance.

Speaker 4

Thanks for that color. Maybe just

Speaker 5

two follow ups on your list there. 1, I know there's been some management changes In the organization, the Head of the President of UroLift, as expected and consistent with timing you said in the past, Retired at the end of the year. Can you just talk a little bit about that? I think ultimately it would help just to hear if there's anything Potentially changing with the way you're viewing the market, the direct to consumer initiatives, management changes that Maybe impacting the business or if this is just purely COVID that led to the still sluggish trend And the Q1.

Speaker 3

Yes. So I wouldn't call the trend sluggish in the Q1. Let's not forget, in January February, COVID was much more severe than it was in the Q4. And for us to be able to deliver a growth of approximately 2% in Q1 Consistent with Q4, I would see that as an achievement. Another little bit of color I would give you, Rich, is that in the 1st 2 months, January February, we had a decline of approximately minus 8% for UroLift.

And in the month March, it was positive north of 30% in absolute growth year over year in the month of March. And we continued, as I said earlier, to see that improving trend as we went into April. So we feel really positive about Europe. Nothing has changed The end markets and we're still very positive. As anticipated, the President of the business unit did leave at the end of the year, but we have an industry veteran Coming in to take over that business unit and the core team is still there.

Our turnover in that business unit is Significantly less than our turnover in any other part of Teleflex and Teleflex turnover is well below industry averages. I've said it many times, Rich, you just can't beat culture and our people. We'll stay with Intelliplex because of the closure and because of the significant opportunities within there. So No significant changes within the organization below the President level.

Speaker 5

Thank you very much, Lou.

Speaker 4

Appreciate it. Thanks, Rich.

Speaker 1

And your next question comes from the line of Cecilia Furlong with Morgan Stanley.

Speaker 6

Great. Thanks for taking our questions. I guess I did want to continue with UroLift. You talked about ex U. S.

Expansion into France as well as Japan coming online in the I guess just as we're thinking about guidance and recovery from COVID, can you talk a little bit about just you're expecting from the U. S. Market recovery from the DTC campaign as that flows in OUS and then Just layering that on it. As you look at gross margin impact from Euro 2 rolling out, just would love your thoughts on

Speaker 3

Okay. So again, we've again reiterated our plus 30% growth for UroLift in the year. And regarding the growth in France and Japan, we see those as incremental growth to our normalized growth levels We see that the growth and the recovery in UroLift is going to be really A U. S. Phenomenon this year, and we would advise the investment community to focus on the U.

S. Market. We will generate some revenue In Japan, but we have a mandated registration study to complete And gather some data. So I would really see Japan ramp and France ramp for that matter as really being a 2022 story Where you see the incremental revenue really get start to gain momentum. And as I said earlier, I would see that as An incremental growth driver into the future.

With regards to the UL2, we still expect That we will have the key North American market pretty much converted by the end of 2022 and we will have an uptick in our gross margins Of 4 full percentage points, which will account for about 40 basis points for Teleflex in our entirety. Regarding DTC, we are very encouraged by what we saw last year with our DTC campaign. And as I said in my prepared remarks, we are planning to run the DTC campaign for a full year. Because of some of the learnings that we've made during that time, We're doubling the spend, but we're more than doubling the number of impressions we anticipate making. So we expect to make about 125% Plus additional impressions with the campaign in 2021 as compared to 2020.

We are also very encouraged by the number of patients that engage with the urologist and encouraged by what we the appointment levels we see being generated out of that. So we are investing more heavily behind DTC by rolling it out for a full year in 2020 Compared to 2020. So and in a recovering COVID environment, there are many patients that we have Put under the care of a urologist through the DTC campaign, that should turn into procedures now that people feel more confident to go back in and get procedures done in the back half Of this year 2021.

Speaker 6

Great. Thank you for the color. And I guess I wanted to just see On the Medica, you talked about Q1 performance slightly ahead of your expectations. Can you just talk a little bit about how that integration effort has gone so far And really just how you're looking at that initial $60,000,000 to $70,000,000 you called out at the time of acquisition? And thank you.

Speaker 3

Thank you. Yes, so the integration is going exceptionally well. The ZMedica team are very welcome to the Teleflex family. We are seeing no turnover within our identified retention pool. We have approximately 21 work streams And we're about 35% completed already.

Regarding the $60,000,000 to 70,000,000 And the $0.21 to $0.26 in earnings guide that we gave, we feel we're very comfortably within that $60,000,000 to 70,000,000 And the product is doing better than we would have anticipated right out of the gate. So we're really happy with how things are going with ZMedica.

Speaker 6

Great. Thank you.

Speaker 1

Cheers. And your next question comes from the line of Matt Taylor with UBS.

Speaker 7

Hi, guys. Thanks for taking the question. So I wanted to circle back on your list and ask one about New versus existing surgeons, do you have any insight into the trends that you're seeing? Are you seeing that The surgeons who have used UroLift in the past are showing same store growth still or how much of your growth is coming from each of those buckets?

Speaker 3

So traditionally, about 2 thirds of our growth comes from existing and a third comes from new users. We haven't seen any significant change in that. As we got to the Q4 and this continued within the first, We're seeing the average number of procedures being done by urologists holding pretty firmly and that's quite encouraging. One thing that we did see in the Q1 And during COVID, we saw the percentage shift out of the hospital to the ASC and the office in the midst Of COVID, and we saw a few percentage points swing. We've actually seen some of that swing back into the hospital as patients Now feel more confident going back into the hospital and getting the cases done.

So we're very encouraged by that because Our procedure is done in all sites of service. It's done in the hospital, the ASC, in the office. And as we see all of those sites of service begin to come back, As we did in the 1st few weeks of April, the trends are really encouraging for you to look at, Matt.

Speaker 7

Okay, great. And obviously, the April data points are very positive. But is your hypothesis that you're going to Kind of continue to see those levels through the quarter or do you think that you could actually see some momentum acceleration? I mean, are your customers or your sales force telling you that there is a funnel From those canceled procedures in Q1 that are going to start to bounce back as more people get vaccinated?

Speaker 3

Well, we know what the canceled procedures were, Matt, in the Q1, and we know what they were in the Q2. So we've taken the baseline cancellations of 2019 and we have the data on the additional cancellations. So and Cancellations in the Q1 were higher than the Q4 as we'd expect because COVID was more aggressive And we hit record peaks in January February in particular. So we had 850 cases, Which would equate to around $4,000,000 in the Q4 and we had just shy of $920,000,000 in the Q1. So it's Over $4,000,000 of canceled procedures over the base rate.

So those canceled procedures, one would imagine, will come back at some stage As people feel more confident in coming back and having them done. So we're feeling really good about UroLift As it is right there. And of course, as we said earlier, we got the incremental growth drivers then coming in later into the year and into 2022, such as Japan, France and other geographies.

Speaker 7

Great. Awesome. Thanks a lot for those data points. Thanks, Matt.

Speaker 3

Thanks, Matt.

Speaker 1

Your next question comes from the line of Larry Keusch with Raymond James.

Speaker 4

Good morning. Thanks. Liam, just hoping to level set a little bit on And maybe you can I certainly heard the messaging of you do have this post market Study that you have to get done, you're not expecting a lot of revenue this year? But again, just trying to think through sort of what happens with clearance For the UL-two and then kind of sequentially what happens with reimbursement, maybe just walk us through kind of how you're thinking about

Speaker 3

Yes, Larry. So we are with all the documentations prepared and submitted to the authorities. Sorry, we will have them submitted very soon to the authorities. The reimbursement team will meet And they meet once a quarter. So we will have them in, in time for the June meeting.

Whether they review them in the June meeting, we do not know. But if they don't review it and give a decision in June, they will give a decision in December or in pardon me, in September. So that's the gating point, Larry, as to when we will get a decision on the reimbursement in Japan. As soon as we get that decision, we will begin to do procedures To comply to the PMDA mandated study that we have to do. We've already have the team on the ground.

We've The market development specialists on the ground. We've already begun to recruit additional sales individuals on the ground in anticipation of Patient of getting that reimbursement decision. And Japan has an advantage over what we had to do in the United States insofar as that single payer market. So once we get reimbursement, we have reimbursement across all sites through the entirety of Japan. And I think then we would see The revenue in Japan ramp as we go through 2020 beyond.

And again, I'll reiterate what I said, we see this as an addition To the normalized growth levels of UroLift over and above what we've seen in predominantly the United States.

Speaker 4

Okay. I do have a question for Tom, but I just want to clarify one thing, Liam. So are you saying that you haven't filed yet for the Regulatory clearance, and then you have to get that done before the reimbursement meeting? Or does this happen all in parallel?

Speaker 3

Excuse me. No, we have regulatory clearance already, Larry. Pardon me. I was talking about reimbursement

Speaker 4

Submission. Got it. Okay, perfect. And then I guess for Tom, look, certainly on The gross margin side, Tom, you are bumping up against kind of your targets in the pre COVID LRP. Again, just wanted to think about or have you maybe address a little bit about how you think about the sustainability of The gross margin after what we saw in the Q1.

And then secondarily to that question on the restructuring, again, you highlighted The pre tax savings that you have in front of you over the next several years, should we be thinking about that as Really all dropping to the bottom line or would you consider actually investing some of the restructuring savings to fuel growth? Okay. Well, starting with the sustainability of the gross margin. So as we've talked about previously, what's really driving our gross margin are Two things, primarily mix and I would say that UroLift being the greatest driver, we also have the addition of ZMedica this year. And so As we continue to see UroLift and other high margin product offerings continue to outpace the rest of the business, we're going to continue to see margin expansion for this year and into the future.

Now with regard to the other piece of restructuring programs, As mentioned, we do have a couple of years outlined already of programs that are out there and we expect to realize some significant savings. And if you do the math on that, That's close to 2 basis points of margin expansion right there. As we think about do we drop this through, I think from our perspective, we're going to continue to evaluate what are the options to kind of Look at opportunities to enhance growth with further investment behind our Harmitgen brand such as UroLift, Zemetica, Manta, as well as considering what level of profitability increase we've got. So we've got The opportunity to continue to drive meaningful top line growth, meaningful margin expansion, and that's going to translate to meaningful earnings per share growth. We'll continue to evaluate what are the opportunities to invest further to accelerate that top line even more.

Okay. Terrific. Thanks guys. Appreciate

Speaker 3

it. Thanks, Artie.

Speaker 1

Your next question comes from the line of Matthew Mishan with KeyBanc.

Speaker 8

Hey, thank you very much for taking my questions. Hey, Tom, just back to the gross margin. I mean, if mix is really what's Driving a lot of the improvement. Just sequentially, Zmedica, UroLift are all moving Higher, sales are moving higher, probably the mix of COVID related products move a little bit lower. Why would the gross margin decline from here in 2Q, 3Q and 4Q With increasing sales and what's offsetting that?

Speaker 4

Well, I would first say that in the Q1, we had an incredibly clean Quarter from a performance standpoint in manufacturing. And then also to the point you've raised that as we look at the recovery in the back half of the year, we I should say in the Q1, both EMEA and OEM had about 17% constant currency declines in revenue. As we look to the back half of the year, we expect All of those businesses to move into positive territory and that's going to have an adverse impact on our mix. And that will partially offset some of the higher growth from UroLift and other high margin brands. Now obviously, we're waiting to see how the recovery plays out over the next couple of And hopefully, as we continue through the year, we continue to see favorability in the gross margin line.

Speaker 8

Okay, excellent. On the OEM side, when does that inventory normalize versus where Production versus where customer activity is?

Speaker 3

So, Matt, it should lag about a quarter. So you should expect See beginning in quarter 2, a recovery and then in the back half of the year, you should definitely see it start to pick up. So it will lag by about a quarter. My expectation would be that OEM results in Q2 will be better than they were clearly in this quarter and then you get into Positive countries get into the back half of the year. And OEM for the full year should grow in that mid single digit growth rate overall.

Speaker 8

Okay. Excellent. And just back to Tom. So free cash flow was excellent in the Q1. How should we be thinking about free cash flow in 2021?

And have we reached the point now that we're going to see that inflection in free cash flow that you were Talking about back in like 2018, 2019?

Speaker 4

Yes. So the way I'd look at free cash flow is that we'd expect it to be growing kind of in line With earnings growth in the 20% range, a couple of things going on in 2021. First of all, We're going to see an increase from net income. We'll also see an increase as a result of less contingent consideration payments. We spent about a little under $80,000,000 last year and we expect that to be significantly less this year.

However, last year, we also closed out the year with a very, very strong collection cycle where Our DSOs were down considerably from our historical average. And this year, we've planned it to be closer to our historical average. To the extent we We continue to see favorable trends in collections. We could see more than that 20% growth in free cash flow that I cited.

Speaker 8

Thank you very much.

Speaker 3

Yes. Thanks, Matt.

Speaker 1

Your next question comes from the line of Matt O'Brien with Piper Sandler.

Speaker 9

This is Drew on for Matt. I think maybe I know the answer to this question, but I just want to ask about the competitive landscape for UroLift. You have Boston talking about good progress with its Rezum product yesterday. I believe you have Olympus also rolling out a new product in the space. Anything new with those technologies?

And are you seeing any shifts of utilization within the market?

Speaker 3

So we're seeing no changes in the marketplace. I think that year over year growth in this environment is a tough because you don't know what happened in the prior year with some of these companies. So I can tell you last quarter when Teleflex in our entirety, we grew 5.5% On a days adjusted basis. So and if you look at our growth in Teleflex and our entirety in 2019, constant currency Days adjusted, we grew 5.8% over 2019. So we feel that the momentum swing is really moving Favorably for us.

And we also see no changes in the end markets. At the end of the day, it all comes Down to patient outcomes. The no sexual dysfunction, will the man have to wear a catheter and revision rates for UroLift that are Comparable to the gold standard, TORP. And of course, don't forget that the man has a choice with UroLift where they get procedure done. Do they want to go to an ASC or an office, but some of these other technologies, they're restricted as to where they can have the procedure done.

So no change in the end market and I can categorically tell you we have lost no Customer to any competitor.

Speaker 9

Okay. That's obviously great to hear. And congrats on the strong performance with MANTA. I believe you mentioned 30% plus growth. Maybe you could just kind of help us by framing where that number was relative to the estimates And then relative to the penetration targets you laid out a couple of quarters ago?

Thank you.

Speaker 3

So we're very pleased with the growth. You're correct. It was 30% growth within the quarter, which is very encouraging. It is in line with our trajectory even given the worsening with COVID in January February, and we expect to continue to see that momentum build As we go through the remainder of the year and we do believe we will get to our 8% plus penetration by the end of the year. So Manta is Performing very much in line with our expectations and we're very encouraged by it.

Speaker 9

Thank you. Thank you.

Speaker 1

Your next question comes from the line of Anthony Petrone with Jefferies.

Speaker 10

Thanks and good morning. Maybe 1 on UroLift and a couple of regional questions. 1 on UroLift is just maybe the competitive dynamic, I guess both Versus existing alternative devices, also scientists spoke a bit about Rezum on their call. They also saw increasing volumes in March. So just an update on competitive dynamics and getting into new sites would be the first question.

And maybe a second quick one On EMEA, maybe Liam just touched more broadly on EMEA, obviously lagged in the quarter. COVID It's still somewhat heightened. They're opening up. So maybe just thoughts on when we'll see a reversal in EMEA broadly? And then one quick follow-up.

Thank

Speaker 3

you. Yes, Anthony, thank you. So yes, the growth that we saw in March for UroLift was north of 30%, So over the prior year. So we're really encouraged by that. And we're also, as I said earlier, encouraged by the momentum that we saw going into April where We saw continued sequential improvement in our average daily sales going into April, getting back above our pre COVID levels the first time, I mean that's a big watershed moment for us, Anthony, as you can appreciate.

We haven't been consistently back Been back above pre COVID levels for an entire year now. And so the team is absolutely fired up out there in driving that. Regarding your question on EMEA, EMEA was as expected. There's a few dynamics going on there. Last year EMEA received a positive $8,000,000 COVID order in the prior year quarter.

So they had that tough And as we all know, the rollout of the vaccine in Europe is not going as well as it is in the United States. And I think that the increasing cases in COVID in January February and well into March Within Europe was pretty strong, lots of lockdown still going on. Now having said that, the month of April in EMEA has also been Somewhat encouraging. So I would expect the EMEA to have a much better second quarter than it did the Q1. And it would be remiss of me not to mention APAC.

APAC, Anthony, grew over 10% on a days adjusted basis in the quarter from a minus 7% in quarter 4. So that was Tremendous swing for us and China had a really, really strong Q1 as we see procedures begin to come back in that key Geography for us. So that's some of the regional color, Anthony, for EMEA, but also APAC.

Speaker 4

Very helpful.

Speaker 9

And one if

Speaker 10

I could sneak in will be on EZYPLAZ. And maybe just a quick update there and a recap of the opportunity maybe starting Military and then broadly as you roll that out, should we still be thinking about that as addressing $100,000,000 TAM over time? Thanks again.

Speaker 3

Yes, you're absolutely correct. EZ Plaad's address is 100,000,000 TAM, 25 1,000,000 in the military, 75,000,000 in the civilian. As we all know, we're going to begin in the military market to help us develop this product. Very encouraging signs from the FDA. We got a letter from the FDA following our BLA submission stating that the application was Efficiently complete to begin substantive review and the BLA was assigned priority review classification, Which indicates that they're going to it is on a fast track BLA.

Very collaborative. We're getting questions back, is what we would expect. The team is answering them. So very collaborative over and back. And we would Normal approval is but it points to the Q4.

So as they move through this, we'll keep the investment community updated.

Speaker 9

Thank you much. Thanks, Anthony.

Speaker 1

And your next question comes from the line of Mike Matson with Needham and Company.

Speaker 11

Hi, thanks for taking my questions. So there's so much focus here from investors on acquired products I almost feel a little sorry for your R and D team there, but I was wondering if there is any internally developed new products That you're excited about that we should be aware of?

Speaker 3

Yes, Mike. And don't feel too sorry for our R and D team. They're doing a tremendous job internally for us. We have a number of new products that we are excited about being developed internally. Within the anesthesia group, we have Polaris, which is a laryngoscope handle and blade system that we're getting really good traction on.

Within The vascular business, we have Project Phoenix, which is a new ErgoPac that is gaining tremendous traction right now for us Within the group, within the interventional group, we have the Watson Guidewire, which is a 2 in 1 combination product It will be launched later in the week that we're very encouraged by. And of course, the AC3 continues to gain tremendous traction And we had a really strong quarter with that product, in particular in China, as we start to roll that out in that Geography having gained approval for it. So across the board, we've got a lot of products coming through the R and D group. And we've been quite successful in augmenting our revenue growth from new products to the positive over the last number of years. A few years ago, we used to generate 1% in new revenue growth from new products and we've moved that up to 1.5% to 2% over the past number of years.

And the other thing I'd point out and it's not related to your question on new products, but we have also had positive pricing within the quarter. So I think that we're very encouraged by Within the quarter. So I think that we're very encouraged by our ability to increase our prices even in this tough environment And that's a positive sign for us also.

Speaker 11

Okay, thanks. Didn't mean to imply that they weren't doing their job. Investors are focusing on some of the external stuff. So and I wanted to give them a chance to be free to talk a little bit about some of the internal stuff. But And then, I guess just on MANTA.

So MANTA, I mean, look, 30% growth, I don't want to take anything away from that. That's obviously really good. But at the same time, I mean the clinical data on this thing is pretty outstanding. So what is the pushback that you get? I mean, is it just Price, it just seems like a no brainer to use this thing to me.

And if it's price, I mean, do any of the trials have any kind of economic data in them or Do you have any trials planned to collect any kind of economic data to kind of help with the VAC committees and things like that?

Speaker 3

So Through the VAC committee has not been an issue for us, Mike, with the MANTA product. In the Q1, we're really happy with the 30%. The issue we have is COVID in the Q1, quite frankly, in gaining access, because it's difficult to gain access to the hospitals, Especially in January February. Now I know we're sitting here in April and we're January February seemed like a long time ago. But don't forget, we were 250,000 cases a day in January February, they were much worse than November December.

So it was very difficult for us to get sales Representatives, clinical experts out there into the marketplace showing the product. And I would anticipate that we'll continue to see that ramp now As people more people are getting vaccinated and our access to the hospital will be much better.

Speaker 8

Okay. Great. Thank you.

Speaker 1

And you do have a follow-up question from the line of Richard Newitter with SVB Leerink.

Speaker 8

Hi. Just wanted to follow-up.

Speaker 5

It may be some confusion just around the commentary with respect to pre COVID Eurolift Growth rates. Liam, can you just clarify, you've thrown around, I think, greater than 30% in April. What's that relative to? Is that relative to April 2020 or is that relative to April 2019?

Speaker 3

That was relative to So the 30% was in March and it was relative to the March of 2020, Rich. The 30% That I quoted was for the quarter, and that was compared to 2019. So we grew 30% in March compared to March of 2020. And in the whole quarter 1 of 2021, we grew 30% over 2019. As we went into April, our average daily sales got Back to average daily sales levels, we have not seen consistently since January February of 2020 before we headed into COVID.

Speaker 5

Okay. And my understanding was that January February of 2020 were exceptionally Strong, I mean, well north of 30%.

Speaker 3

Yes, our growth in January, February, from my memory, we were about 35 ish percent or something

Speaker 5

Rich. Okay. Thank you very much.

Speaker 1

And your next question comes from the line of Shai Ghan Singh with Wells Fargo. Ms. Singh, your line is open.

Speaker 12

Hi, sorry, can you hear me?

Speaker 3

We can hear you, Shekin.

Speaker 12

Great. Thank you for taking the question. So just looking at pre COVID years, Q2 sales is typically 6% over Q1, EPS is about 6 And I think your Q2 guidance contemplates sequential growth of 9% and EPS flat at the midpoint. So I was just wondering if you could talk to that for Q2 versus Q1. And then just looking at growth on a stack 2 year basis, it appears pretty similar You know for Q2 versus what you're contemplating for the second half.

So you know should we view it you know as conservative and then that brings Final question, which is with respect to backlog. How are you thinking about it? I think you're increasingly hearing that we should expect more of a steady So any commentary on that would be helpful. Thank you.

Speaker 3

Yes, I'll start with the backlog and the I'll address the conservatism and I'll let Tom get The specifics of the guide in the quarter as to where it would be. But I would say that you will see acceleration in in revenue dollars and you'll see acceleration in adjusted earnings per share as you get through the quarter. I think we should start there As we continue to expect the recovery to continue, it's really difficult for us to forecast or identify the backlog And it is difficult for us to build that into any forecast because We don't know what type of capacity that's going to be there within the hospital system or outside of the hospital system for us to get there. We do expect though that backlog should get burned through as you get later into the year and that would be our With regard to whether the guide so the guide would be roughly and I'm talking trying to pitch it towards the middle here, Shagun. It should be about $690,000,000 and about $2.90 in earnings per share at the midpoint in both of the guides that we Gabe, in relation to that.

Now regarding conservatism or not, I think we continue to see some increases In COVID cases in places like India and Japan, we see Americas recovering. We think we'll see OEM continue to get better in the Q2 as we will with EMEA. And we do believe that there could be opportunities for us there in the Q2, but we would prefer to lean more to aggressive at this stage just giving there's a few variance around there. So we would prefer to lean in that direction. And if recovery continues within The Q2, we think that we should be in a good position to take advantage of that.

It would be our thinking. And just to be absolutely clear that $690,000,000 would be up from what we did this quarter, which was Around 6.34%. So it would see significant sequential improvement on an absolute dollar basis on revenue, Shagun.

Speaker 4

And then as it relates to earnings, I think Liam pointed out that we expect to see sequential acceleration in Earnings per share, also we expect to see sequential improvement in adjusted earnings per share versus Prior year, when we take a look at if you go back 2 years, I think we had a really strong Q1. The growth rate isn't as strong In the back half of the year, a couple of things to understand as we look at the Q1 of 2021. I had pointed out earlier that we had a really clean 1st quarter from a manufacturing performance standpoint, and while we're very encouraged by that performance, we're not quite ready to extrapolate that to a full year upside To that level. Additionally, I mentioned that EMEA and OEM were down in the Q1 in terms of revenue growth, and we expect them to recover and turn into positive territory for the back half of the year. And both of those business segments carry a lower gross margin than average.

And I'd also say that in the Q1, we had a really, really significant beat in operating expenses and part of that was due to savings From travel and perhaps slower hiring than expected, but the vast majority of it was due to deferred Projects, so projects that we had expected to get going in the Q1 that we eventually delayed just given COVID and other reasons. Now we do expect to make those up in the back half of the year. So some of that OpEx saving in upside from the Q1, we expect to be Included in the rest of the year spend. So hopefully that helps give you some color as to what's going on from an earnings And why the Q1 just looks so fantastic even when you benchmark against 2 year ago.

Speaker 12

That's helpful. Thank you so much for taking the question.

Speaker 4

Thank you, Shikha.

Speaker 1

And your next question comes from the line of David Turkaly with JMP.

Speaker 8

Good morning guys. I've been bouncing around a little this morning, but I just wanted to ask one quick one For Tom, I think you mentioned what's sort of a hot topic of late in general, but inflation. And I was just curious as to what specifically you're referring you have any input that we should be aware of that may be undergoing some sort of a pricing increase as we think about the rest of this year? Thanks a lot.

Speaker 4

Sure. Well, I would say that we are seeing inflation that's a little bit higher in 2021 than what we've seen historically. A lot of it was anticipated and included in our original plan. Our current projections reflect what we see as the current environment. I'd say the areas where we're seeing inflation is in some material, in particular resin, polyethylene, polypropylene, polystyrene All well above 10% inflation rates.

But overall materials we're seeing at a sub 2% inflation Growth rate, I would say that select labor markets, we've got some inflation going on in Malaysia That would be pushing up around 5%. But overall, I would say that total Direct and direct labor is sub 5% in terms of inflation. The other area that we are seeing heightened inflation rates is in our freight. In particular, our sea freight is up significantly where it's up 20% this year. And I think if you follow what's going on, there just isn't capacity.

So collectively, as we look at all of the different inflation components in manufacturing, we're up around 3% For the year is our current expectation. That's about a full point versus what we've seen historically. And again, that's fully reflected in our

Speaker 3

And Dave, I would just add to that and I mentioned a little earlier, we anticipated seeing some of this inflation. So we took some About a year ago, we started taking some actions on some of our pricing initiatives and that started to come True in this Q1 and pure pricing in this Q1, we were positive about 20 basis points. So we're quite encouraged by that. We anticipated this and we immediately began to plan to have an offset. So modest price increases in some of our more selective

Speaker 1

I would now like turn the conference back over to Jake Elguise for closing remarks.

Speaker 2

Thank you, operator, and thank you to everyone that joined us on the call today. This concludes the Teleflex Incorporated First Quarter 2021 Earnings Conference Call. Have a nice day.

Speaker 1

Ladies and gentlemen, thank you for participating. You may now disconnect your lines.

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