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Edited Transcript of TFX earnings conference call or presentation 1-Aug-19 12:00pm GMT

Q2 2019 Teleflex Inc Earnings Call

LIMERICK TOWNSHIP Aug 8, 2019 (Thomson StreetEvents) -- Edited Transcript of Teleflex Inc earnings conference call or presentation Thursday, August 1, 2019 at 12:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Jacob P. Elguicze

Teleflex Incorporated - VP of IR & Treasurer

* Liam J. Kelly

Teleflex Incorporated - President, CEO & Director

* Thomas E. Powell

Teleflex Incorporated - Executive VP & CFO

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Conference Call Participants

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* Anthony Charles Petrone

Jefferies LLC, Research Division - Equity Analyst

* Brian David Weinstein

William Blair & Company L.L.C., Research Division - Partner & Healthcare Analyst

* David Ryan Lewis

Morgan Stanley, Research Division - MD

* Kevin Michael Farshchi

Piper Jaffray Companies, Research Division - Research Analyst

* Kristen Marie Stewart

Barclays Bank PLC, Research Division - Research Analyst

* Lawrence Soren Keusch

Raymond James & Associates, Inc., Research Division - MD

* Matthew Ian Mishan

KeyBanc Capital Markets Inc., Research Division - VP and Senior Equity Research Analyst

* Michael Stephen Matson

Needham & Company, LLC, Research Division - Senior Analyst

* Richard S. Newitter

SVB Leerink LLC, Research Division - MD of Medical Supplies & Devices and Senior Research Analyst

* Shagun Singh Chadha

Wells Fargo Securities, LLC, Research Division - Associate Analyst

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Presentation

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Operator [1]

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Good day, ladies and gentlemen, and thank you for standing by. Welcome to the Teleflex Incorporated Second Quarter 2019 Earnings Conference Call. (Operator Instructions)

Now it's my pleasure to turn the call to Jake Elguicze, Treasurer and Vice President of Investor Relations.

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Jacob P. Elguicze, Teleflex Incorporated - VP of IR & Treasurer [2]

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Good morning, everyone, and welcome to the Teleflex Incorporated Second Quarter 2019 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 the available by dialing (855) 859-2056, or for international calls, (404) 537-3406, passcode 8346258.

Participating on today's call are Liam Kelly, 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&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 and 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 or press release today as well as our filings with the SEC, including our Form 10-K, which can be accessed on our website.

With that, I'd like to call -- turn the call over to Liam.

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Liam J. Kelly, Teleflex Incorporated - President, CEO & Director [3]

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Thank you, Jake, and good morning, everyone. It's a pleasure to speak with you again.

The second quarter of 2019 was very positive for Teleflex, as we accelerated the momentum in our global business, delivering 7% revenue growth on an as reported basis and 9.6% on a constant currency basis. When normalizing for the impact of 1 less shipping day, second quarter constant currency revenue growth was 10.8%.

Like the first quarter of the year, during quarter 2, the strength in our top line performance was once again broad-based, driven by improvement across nearly every global product category. This included 42.7% growth in Interventional Urology, 12% growth in Vascular Access, 9% growth in Surgical and 8.8% growth in Interventional Access; while from a geographic perspective, we achieved particularly strong growth within the Americas and Asia, where constant currency revenue growth was 13.1% and 10%, respectively.

Turning to some other key metrics. We reported adjusted gross margin of 57.7%, adjusted operating margin of 25.2% and adjusted earnings per share of $2.66, which represents an increase of 7.7% over the second quarter of 2018. Our adjusted earnings per share performance in quarter 2 was slightly better than we expected in our last earnings call, despite a greater-than-expected headwind from FX. If we were to normalize for the year-over-year currency headwind, our adjusted earnings per share would have grown 13.8% during quarter 2.

In summary, we are incredibly pleased with our better-than-expected revenue performance in the second quarter and first half of the year. This has led us to increase our full year 2019 guidance for constant currency revenue growth from a range of between 6% and 7% to a range of between 7.5% and 8%.

Additionally, based on strong UroLift performance during the first half of the year, we are increasing our full year UroLift revenue growth guidance from a growth rate of approximately 30% to a growth rate of approximately 35%.

We are pleased that our increased 2019 revenue growth expectations are being driven by a combination of both UroLift and non-UroLift products. And if we were to break down components of our full year constant currency revenue guidance raise on a dollar basis, approximately 1/3 of the raise is driven by UroLift, while approximately 2/3 is driven by the remainder of our products.

Moving away from revenue. Today, we are also reaffirming our full year 2019 adjusted gross margin guidance, but we are slightly lowering our full year adjusted operating margin guidance largely due to increased headwinds from FX and decisions we made to make certain growth and infrastructure investments.

Yet due to a combination of strong revenue performance, coupled with reduced expectations for interest expense, we can offset a significantly worse impact from FX, and we are reaffirming our adjusted earnings per share guidance range of $10.90 to $11.10. We are pleased with our expectation to grow full year 2019 adjusted earnings by 10% to 12%, while funding investment behind key revenue growth opportunities and offsetting headwinds from foreign exchange and tariffs.

With that as an overview, let's now look at quarter 2 revenue in more detail. I will begin with a review of our reportable segment revenues and unless otherwise noted, the growth rates I will refer to are on a constant currency basis.

The Americas delivered revenues of $373.8 million, which is an increase of 13.1%. This was driven by our Interventional Urology and Vascular Access product categories.

Moving to EMEA. It reported revenues of $147.1 million, which represents an increase of 1.9%. During the quarter, the growth was led by our Interventional Access and Vascular Access products. However, the performance of this region was slightly lower than what we anticipated a few months ago due to the timing of certain orders. As we look forward, we expect EMEA performance to improve in the second half of the year as compared to the performance during the second quarter.

Turning to Asia. Revenues totaled $75.2 million, which is an increase of 10% as compared to the prior year period. From a product standpoint, growth was strongest within our Surgical and Vascular Access categories, while from a geographical perspective, our business in China grew 15%, and we also saw strength in Korea and Southeast Asia.

And lastly, our OEM business reported revenues of $56.4 million, which represents an increase of 8.5%. Growth here was led by strength in our suture and catheter product offerings. On a full year basis, we continue to expect this business to grow in the upper single-digit range. However, due to a difficult comparable as well as the timing of certain orders, we expect growth within this segment to be relatively flat as compared to the prior year period during the third quarter.

Now let me move to a discussion of our revenues by global product category. Like my comments regarding our reportable segments, my comments regarding our global product category growth will also be on a constant currency basis, unless otherwise noted.

Starting with Vascular Access. Second quarter revenues increased 12% to $153.6 million. This was driven by strong growth in CVCs, PICCs and EZ-IO. Additionally, we saw an increase in distributor orders during quarter 2 that positively impacted results. This was essentially the reverse of the distributor destocking that negatively impacted our quarter 1 vascular results.

Moving to Interventional Access. Second quarter revenue was $104.8 million, which is an increase of approximately 8.8%. The strength of this business during quarter 2 was broad-based, with growth in complex catheters, biologics, OnControl and intra-aortic balloon products.

And while not a meaningful driver of Q2 growth, let me provide you with a brief update on MANTA, our large bore closure product. The first 3 months of MANTA's limited market release have gone very well, as the product has received strong positive feedback from key thought-leading physicians as we continue to conduct price discovery in the market. We have made good early progress in our strategy to generate positive clinical outcomes at key institutions, and we remain on track with our strategy of generating additional positive physician and patient experiences as we move through the remainder of 2019. We continue to believe that MANTA will contribute to our top line in a more meaningful way in 2020.

Turning to Anesthesia. Second quarter revenue was $85.7 million, which is a decrease of 0.9%. The decrease here is primarily driven by softness in airway and pain management products.

Turning to a brief update on RePlas, which going forward, will be referred to by its new commercial name EZPlas. As a reminder, we are on a fast-track approval process with the FDA, and our most recent public comments regarding this product indicated that we expect this to complete our BLA submission by the third quarter of 2019.

In the course of our frequent communications with the FDA, which have been highly collaborative, we recently received additional questions from the FDA. Although we previously anticipated many of these, there were others that will require additional analysis and testing, which will take more time to complete. Therefore, we no longer expect to complete the BLA submission by the third quarter of this year. While this is unfortunate, we view this as a temporary setback. The fact that the BLA submission will take additional time to complete is in part due to the unique nature of the product, as a biologic product like this has never been approved by the FDA before.

It is important to understand that there was no revenue assumed in our 2019 financial guidance related to this product, and less than $10 million in revenue by 2021 in the long-range plan estimates we shared at our Investor Day last year. As we move forward and continue to work with the FDA, we will continue to provide updates as part of our quarterly earnings calls as and when we receive further information on the BLA submission and the associated regulatory timing of EZPlas.

Shifting to our Surgical business. Revenue increased 9% to $95.6 million, driven by sales of ligation clips and surgical instruments. While this business fundamentally performed very well in quarter 2, many of you will recall that it was also up against an easy year-over-year comparison.

Moving to Interventional Urology. Revenue increased 42.7% to $67.9 million. Our sales force continues to make excellent progress, driving physician adoption of the UroLift system, and we expect to train a total of 450 new urologists during 2019. From a patient demand perspective, our direct-to-consumer program is performing well, and it is driving new patients toward talking to their urologist about whether they are a good candidate for UroLift as a solution to their BPH.

Transitioning to UL 2. We continue to expect to begin the rollout of UL 2 in the latter half of this year, with a full conversion of the U.S. physician base from UL 1 to UL 2 expected in 2021. We are also continuing to actively seed the market for the launch of UroLift in Japan, and we remain on track for a limited market release in mid- to late-2020, with revenues ramping more meaningfully in Japan during 2021. Given the outperformance of UroLift in the first half of the year, we are raising our annual 2019 Interventional Urology revenue growth from approximately 30% to approximately 35%.

And finally, since OEM was covered in our segment review, let me summarize second quarter revenue for the businesses within our Other category, which consists of our respiratory and urology care products. Revenues were up 0.3% on a constant currency basis, totaling $88.4 million. This is driven by an increase in sales of our bladder management products, offset by declines in sales of our respiratory products.

That completes my comments on quarter 2 revenue performance. Next, I would like to briefly discuss some important clinical and reimbursement updates on UroLift.

First, we are pleased to announce that Anthem, one of the nation's leading health insurance providers, has revised their surgical and minimally invasive BPH medical policy to revise coverage for UroLift. With the announcement of Anthem coverage, UroLift has now achieved coverage by all national and regional commercial plans and all independent licensees of the Blue Cross Blue Shield Association as well as 100% Medicare coverage.

Given that Anthem was the last large commercial payer to change their coverage policy on UroLift to positive, our reimbursement team's focus is now on supporting this strong coverage with robust clinical and real-world data. And as with any new commercial payer coverage decision, Anthem will take time to work through the commercial channel. Therefore, we do not expect any material upside to our 2019 UroLift guidance due to this coverage decision.

Let me move briefly to a clinical data update. A meaningful part of our strategy to make UroLift the standard of care to treat BPH is to create an industry-leading, high-quality set of published clinical evidence.

On our last earnings call, we announced our 1,413 patient real-world study and that results were consistent with those seen in previous clinical studies of the UroLift System, even with a more diverse patient population. In July, the study was published in the Journal of Endourology. Its publication serves as a tool for our sales team to use when calling on both new and existing physicians.

In closing, I would like to reiterate how pleased we are with our second quarter and first half of the year performance. Revenue growth has been incredibly strong, driven by a broad spectrum of products and geographies, which led us to increase our revenue guidance for the full year. We have been working to build a product portfolio capable of accelerating revenue growth and gross margin expansion and feel we are on track to achieve that goal.

When you take a step back and look at the midpoint of our increased full year 2019 constant currency revenue growth guidance range, approximately 2.8% of our expected growth is driven by UroLift and nearly 5% is being driven by the remainder of our products. In fact, the midpoint of our increased constant currency revenue growth guidance range indicates that we expect to grow approximately 7% during the second half of 2019, and this is against more difficult comparisons. The ability for us to accomplish this gives us additional confidence in our ability to consistently grow between 6% and 7% over a multiyear period.

In addition to continued revenue growth in the second half of the year, we also expect to generate a material improvement in our adjusted gross and operating margins, which would translate into meaningful earnings and free cash flow generation. And as such, we are reaffirming our full year adjusted earnings per share guidance range.

That completes my prepared remarks. I would now like to turn the call over to Tom for a more detailed review on our second quarter financial results and full year 2019 financial guidance. Tom?

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Thomas E. Powell, Teleflex Incorporated - Executive VP & CFO [4]

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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 profit was $376.6 million versus $348.3 million in the prior year quarter or an increase of approximately 8.1%. Adjusted gross margin increased 60 basis points to 57.7%. The expansion in adjusted gross margin primarily reflects increased sales volumes, benefits from cost improvement programs and a favorable sales mix of higher-margin products. Partially offsetting these gains were negative impacts from foreign exchange, incremental tariffs, higher logistics and distribution costs and inflation.

Adjusted operating profit was $164.7 million as compared to $158.8 million in the prior year. Adjusted operating margin in the second quarter of 2019 was 25.2%, which is a decrease of 80 basis points over the prior year period, as the improvement in gross margin was offset by the negative impact from foreign exchange, additional selling expenses related to the revenue upside and select investments designed to upgrade our quality systems, strengthened protection of our IP portfolio and enhanced customer experiences while interacting with Teleflex. On a currency neutral basis, adjusted operating margin would have been approximately flat to a year ago period.

Continuing down the income statement. Net interest expense decreased to $20.3 million from $26.5 million in the prior year quarter. The decrease primarily reflects the impact of our cross-currency swap agreements.

Moving to taxes. For the second quarter, our adjusted tax rate was 13.4% versus 12.7% in the prior year period. The increase in our adjusted tax rate is primarily due to the mix of earnings in higher tax jurisdictions as well as a reduced amount of windfall benefit from stock-based compensation.

Adjusted earnings per share was $2.66 or an increase of 7.7% as compared to the prior year. We are encouraged by the strength of our earnings performance, as this result includes a foreign currency headwind of $0.15. So on a currency neutral basis, adjusted earnings per share increased by approximately 13.8% in the second quarter.

In addition to the FX headwind, second quarter earnings also included incremental year-over-year tariff expense, which reduced earnings by approximately $0.03 as well as a headwind from the divestiture of our catheter reprocessing business, which contributed $0.01 in the prior year quarter.

Turning now to select balance sheet and cash flow highlights. During the first 6 months of 2019, cash flow from operations totaled $157.3 million compared to $181.6 million in the prior year period. The decrease in cash flow is primarily attributable to contingent consideration payments.

Finally, during the second quarter, we further reduced our outstanding debt by approximately $28 million, and our net leverage stood at approximately 2.63x.

This completes my comments on the second quarter results. Now I'll move to 2019 guidance updates. Given our performance for the first 6 months of the year and our expectation for the remainder of the year, we are increasing our full year constant currency revenue growth guidance from a range of between 6% and 7% to a revised range of between 7.5% and 8%. We are also increasing our as-reported revenue growth guidance from a range of between 5% and 6% to a revised range of between 6% and 6.5%. Our current expectation is that currency is a 150 basis point headwind to revenue.

Continuing down the P&L. We are reaffirming our previously provided GAAP and adjusted gross margin guidance ranges. However, we are lowering our GAAP and adjusted operating margin guidance ranges. Our updated adjusted operating margin guidance range is reduced by 50 basis points from a range of between 26.5% and 27% to a revised range of between 26% and 26.5%.

Similar to the second quarter discussion, reduction in full year adjusted operating margin expectations can be attributed to a couple of items. First, a less favorable FX environment versus our previous expectation. We project that 2019 operating margin will be adversely impacted by an additional 25 basis points versus our previous expectation. Second, additional selling expense associated with the revenue outperformance in UroLift and other areas of the business. And then third, proactive investments designed to both protect and enhance future growth prospects. The investments include upgrades to our quality systems, strengthened protection of our IP portfolio and enhanced customer experiences while interacting with Teleflex.

Moving now to interest expense. On our last earnings call, we pointed the investment community to the low end of our $87 million to $90 million range. However, to date, LIBOR rates have trended favorable versus expectation, and we have now included a 25 basis point reduction for 2019. As a result, we are lowering our full year interest expense guidance to a range of between $82 million and $83 million.

Turning to taxes. We are reaffirming our previously provided range of between 14% and 14.8%, although we now expect it will be at the very low end of that range.

From a share count perspective, we now expect full year weighted average shares to be closer to 47.1 million as compared to our prior expectation of 47.2 million.

And that takes me to our GAAP and adjusted earnings per share ranges. On a GAAP basis, we are increasing our full year guidance from a range of between $6.72 and $6.84 to a new range of between $6.82 and $6.94.

On an adjusted basis, we are reaffirming our previously provided guidance range, which called for earnings of between $10.90 and $11.10. Implicit in this adjusted EPS guidance range is our current FX assumption of $0.35 full year headwind versus our previous expectation of $0.20. So given the strength of the revenue outperformance, we are able to maintain earnings guidance despite a $0.15 increase in the headwind from FX.

In closing, we are very pleased with the top line growth achieved in the first half. The acceleration and growth was broad-based across our portfolio of products. We believe the investments made to date are paying dividends and those planned for the balance of 2019 will serve to further strengthen our business platform and provide the framework for continued top line acceleration.

While foreign exchange has somewhat tempered earnings growth, the underlying constant currency operating performance has been strong. Adjusting for currency, first half adjusted EPS grew by 13% and further adjusting for the China tariffs, first half adjusted EPS grew by 14.7%. So a very solid start to 2019.

And that concludes my prepared remarks. I'd like to now turn the call back to the operator for Q&A.

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Questions and Answers

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Operator [1]

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(Operator Instructions) And our first question is from David Lewis with Morgan Stanley.

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David Ryan Lewis, Morgan Stanley, Research Division - MD [2]

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Congrats on a very nice quarter. Liam, there's a -- there's a lot of things to focus on here obviously NeoTract. But I wanted to focus more on what we used to call the core business. Two specific businesses, Liam, Surgical and Vascular took big steps forward this quarter. And I wonder if you can just sort of talk about the momentum you're seeing in those businesses and outlook for the back half of the year? And then I had a follow-up for Tom.

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Liam J. Kelly, Teleflex Incorporated - President, CEO & Director [3]

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Yes. Thanks, David. And yes, we're very pleased with the quarter. What we saw in Vascular was really in the first quarter, as I outlined in our calls, we saw some destocking by distributors. And then in this second quarter, we saw that restocking as we had anticipated. So if you look at a nonday's adjusted Vascular Access growth through the first half of the year, Vascular Access grew by 7.2% through the first half of the year. Now we expect Vascular, as we said, to be in the mid-single range, maybe not quite in the 7.2% range in the back half because it runs into a tougher comp in the back half of the year. If you recall back to last year, actually, Vascular, in Q3, grew by about 7%, then in Q4, grew by about 6%. So they're buttoned up against slightly tougher comps. But notwithstanding that, the growth in Vascular is really, really positive for us and it's coming from areas that we want it to come from, PICC as we continue to take share and EZ-IO and Vidacare had a really strong second quarter.

Your question on Surgical. Surgical had a really good second quarter, growing at 9%. They have a -- again, it's a cost comparison, David. They had a weaker comp comparison to last year. If you recall the last year, they declined by about 3%. So that helps them, but notwithstanding that, now that we've anniversary-ed the exit of that trocar business, we're seeing the Surgical business really perform very well and very much in line with expectations. And on a full year basis, again, we'd expect the Surgical business to be in that mid-single growth rate for us.

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David Ryan Lewis, Morgan Stanley, Research Division - MD [4]

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Okay. No. Very helpful. And then Tom, FX headwinds were sort of well understood into the quarter and with previous much. But can you just walk us through the implied guidance for back half of the year? Basically, with the new updated guidance down 50 bps, we need to see kind of 3.5 points of margin expansion into the back half of the year. Can you sort of walk us through what gives you the visibility and confidence that you can deliver that number?

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Thomas E. Powell, Teleflex Incorporated - Executive VP & CFO [5]

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Okay. Well, certainly, a fair question. And to your point, FX was understood. We did have a larger-than-expected FX impact in the second quarter due to some balance sheet revaluation.

But let me just talk about full year. So for the first quarter of the year and the second quarter, we saw an increase in operating margin of about 150 basis points. And as we move towards the back half of the year, we anticipate further sequential operating margin expansion. Approximately 60% of our anticipated operating margin expansion in the second half is expected to be driven by higher gross margins, and 40% of the operating margin expansion is expected to be delivered through better operating expense leverage down in the OpEx lines.

Now the gross margin expansion from the first to second half is expected to be generated by a combination of manufacturing cost improvements, further benefits from various restructuring programs as well as benefits from product and geographic mix. And while we expect to see a modest increase in the total operating expense dollars in the second half of the year compared to the first half, we also anticipate an increase in the second half revenue, that results in improved leverage of our overhead cost structure. I think at a midpoint, we're about $70 million more revenue in the second half, and that drives some good leverage.

This, coupled with the fact that we incurred certain operating expenses in the first half of the year that we don't expect to reoccur in the back half of the year, such as trade shows, investments made to enhance customer experience as well as some costs to strengthen our key portfolio, do lead to reduced operating expenses in the back half.

Traditionally, we've seen much better profitability in the second half versus first half given some of the upfront spending that goes on in the first quarter. So we recognize there's some work to be done on the op margin, but we understand the drivers that need to take place and the organization is focused to deliver on that.

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Operator [6]

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Our next question comes from Larry Keusch with Raymond James.

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Lawrence Soren Keusch, Raymond James & Associates, Inc., Research Division - MD [7]

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I guess, Liam, I'm left with just some broad thoughts on M&A and clearly, your leverage at 2.6x leverage gives you a position to go out and transact deals. I'm really just sort of curious as to kind of how you're seeing the environment out there, asset valuations. Can you actually drive returns given the current valuation environment out there?

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Liam J. Kelly, Teleflex Incorporated - President, CEO & Director [8]

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Yes. Larry, you are absolutely correct in your assessment. We're at 2.6x leverage. We have the capacity to do a scaled transaction should we find this. I think Teleflex is in a pretty unique position, Larry, insofar as we have capacity but no urgency. If we find the right asset, we, for sure, will be in a position to pull the trigger and get the deal done. Obviously, we're very financially disciplined and always have been and will be in the future. We will only do transactions that will give benefit to our shareholders.

The environment is a little frothy out there; you're correct. But in fairness, Larry, it's always been frothy with the good-quality assets. It's gotten a little frothier with the poorer-quality assets, that's been my observation. But they're never the assets that Teleflex has been interested in anyway. So have capacity but no urgency, Larry, is how I'd position that. But we never, ever, ever stop looking, and we are active in the marketplace.

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Lawrence Soren Keusch, Raymond James & Associates, Inc., Research Division - MD [9]

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Okay. That's perfect. And then I just wanted to pivot over to UroLift in Japan specifically. Obviously, that's a -- as you look at this multiyear, multigeography growth engine with that product, that's going to be an important market for you. I guess sort of 2 questions embedded here. Number one, your comments were that you would expect to get this thing going midyear to the latter half of 2020. Just wanted to get a sense, is that slipping a little bit?

And then along that line, could you sort of help us just think about as you have discussions with urologists over there, are there any dynamics in that market that would make it behave differently than the U.S.? I'm just trying to gauge how quickly this market may start to gain traction.

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Liam J. Kelly, Teleflex Incorporated - President, CEO & Director [10]

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Yes, Larry. So first of all, I would say there's no change from our thinking. So we always thought it would be in the latter half of 2020 that we would get the reimbursement approval and that we would start generating revenue by 2021. So nothing changed in our thinking with regard UroLift in Japan.

In the same way as we classified the U.S. market as a $6 billion market, the Japanese market is a $2 billion market. So you are correct in your assessment; it's a significant opportunity.

Now, I would remind the investment community that in our original LRP, we had not anticipated any revenue for Japan in 2021, which is the last year of our LRP. So we see this as a potential for upside.

Regarding the dynamics of the market, Larry, we don't see a significant difference in the dynamics of the market between Japan and the U.S. at this stage. We do see a very collaborative relationship with the Japanese Urology Association (sic) [Japanese Urological Association] and the U.S. urology association. And we have met with many Japanese urologists at the American Urology Association (sic) [American Urological Association] meeting every year, and we continue to build relationships with those urologists.

And also I would also remind you not to forget the urologists know us very well in Japan from using the Weck Hem-o-lok clip. So we already have a relationship with them in the same way as we had in the United States. This is an area and a call point that Teleflex knows very well and it's a call point that we would really be interested in, in growing further, back to your original question on M&A. If we would find something in the men's health space, that would be of interest to us, Larry.

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Operator [11]

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Our next question comes from Richard Newitter with SVB Leerink.

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Richard S. Newitter, SVB Leerink LLC, Research Division - MD of Medical Supplies & Devices and Senior Research Analyst [12]

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One bigger picture one on growth and then one on UroLift. So Liam, just starting on the investments that you're making. You're pulling forward a little bit of the investment spend in the first half. So I'm just curious if you could remind us where exactly that incremental spend is going? And what the time lines are for the payoff there? And within the context of answering that, you're trending your top line meaningfully higher, double-digit territory ex selling days. I guess as we think of the front part of the long-range plan and the -- kind of the pulled-forward spend, should we be thinking of you guys maybe a little bit more towards the high single digit or the upper end of your long range, 6% to 7%, over the front part of your plan? Is that a fair assumption with kind of the spending and what the payoff time lines might be there?

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Thomas E. Powell, Teleflex Incorporated - Executive VP & CFO [13]

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Yes. So first of all, I'll say, we are incredibly happy with the first 6 months of our LRP, and it is the first 6 months of our LRP. So clearly, the strategy is working. Our 5 that drive are all the ones that are delivering through the first half of the year: Interventional Urology, greater than 42%; Interventional Access, almost 13%; APAC greater than 10% through the first half; Vascular, greater than 7% where PICCs and EZ-IO are housed; and, of course, OEM greater than 10%. Obviously, we've updated our guidance today to constant currency 7.5% to 8% for this year in the first year of our LRP, which was incredibly encouraging. And it does show, Rich, to your point, that the pull-forward of investments is working and clearly, the strategy that we deployed is working for Teleflex.

With regard to when you see the return. Obviously, the increased revenue carries an additional expense with it in commissions and things like that, Rich. They don't reoccur in the following year. The revenue is with you forever. So therefore, that's your jump-off point and the base for the commissions and -- for the following years. So we would anticipate that we would have a good solid position in order to be able to deliver our 60% to 61% and our 30% to 31% as we outlined in our LRP. So couldn't be happier about the start of the LRP and really think that the revenue growth is a key driver and the strategy is working.

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Richard S. Newitter, SVB Leerink LLC, Research Division - MD of Medical Supplies & Devices and Senior Research Analyst [14]

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Okay. And just on UroLift. I think you said, just 1,400 planned training in 2019. Could you just describe the doctors and the characteristics of the types of doctors that you're training now versus maybe 6 months ago? And what are you seeing in potentially sizes kind of moving more into the mass adoption or past the early adopter phase, if anything?

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Liam J. Kelly, Teleflex Incorporated - President, CEO & Director [15]

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Yes. So just to clarify, Rich. What we said was we would train over 450 docs in this year, in 2019. At the second quarter, we had said that we had trained over 2,000 urologists so far of the 12,000 that are available. And what we have seen is that a urologist in any spectrum can become a champion. So this is very encouraging because at the end of the first quarter, we've trained 1/6 of the docs, and we were generating global revenues of around $60 million. And I think that moving from the early adopters to the fast followers, we have always been and continue to be cautious on the ramp as you get into that group because it is more of a clinical field to the fast followers.

Now I will say that what is incredibly encouraging to me and the management team is the real-world data that we have to support that fast follower adoption. And the real-world data as compared to the L.I.F. T. study, there are some real key points here: IPSS scores in real-world after 24 months is a 9-point reduction compared to L.I.F. T.; quality of life, still in the 40% as compared to the L.I.F. T.; catheter rates, 99.5% of patients were catheter free at completion of the study versus 32% in the L.I.F. T., which is a significant improvement; and, of course, retention rate, 87% of men that -- were catheter free with the UroLift. And this, I think, Rich, is what's going to set us apart and allow us to bring in these early adopters but not all technologies can say that their real-world data is comparable to the clinical study data that was published to bring the product to market.

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Richard S. Newitter, SVB Leerink LLC, Research Division - MD of Medical Supplies & Devices and Senior Research Analyst [16]

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Congrats on the great quarter.

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Liam J. Kelly, Teleflex Incorporated - President, CEO & Director [17]

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Thanks, Rich.

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Operator [18]

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And our next question comes from Shagun Singh with Wells Fargo.

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Shagun Singh Chadha, Wells Fargo Securities, LLC, Research Division - Associate Analyst [19]

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Congratulations on a great quarter.

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Liam J. Kelly, Teleflex Incorporated - President, CEO & Director [20]

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Thank you.

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Thomas E. Powell, Teleflex Incorporated - Executive VP & CFO [21]

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Thank you.

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Shagun Singh Chadha, Wells Fargo Securities, LLC, Research Division - Associate Analyst [22]

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Liam, I wanted to touch on core growth. You've delivered pretty strong results in the first half despite the 1 less selling day. But historically, the core -- the range for the core growth has been pretty wide. So how should we think about growth in your core portfolio relative to about -- I guess about 5% or so that you delivered in first half? And then I have a follow-up.

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Liam J. Kelly, Teleflex Incorporated - President, CEO & Director [23]

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Thank you. That was the point I was trying to make in my prepared remarks. If you look at our full year increased guidance range, first of all, 2/3 of the growth is coming from ex UroLift, if I can put it that way. And then if you look at our complete growth for the year, if you take the midpoint of our growth, which will be around 7.8%, 2.8% of that growth is coming from UroLift and 5% is coming from All Other.

And I know there has been a question for Teleflex around the core growth or growth outside UroLift, is it sustainable? And we've always said that this is one of the misunderstood things about Teleflex. We always internally were incredibly confident that, that business had the capacity to perform at the levels that we are now seeing, and we believe that it is sustainable. And I would add that what gives me that belief is that we continue to see our in-customer tracings notch up, and it did the same again in the second quarter. So the end-customer demand is there.

We had a slight destocking in Q1, restocking in Q2. But if you look at the half year basis, it's also in that 5% range with UroLift adding just a little bit over 3%. So I think that it's very encouraging for Teleflex because it's so broad-based and our entire portfolio is performing well.

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Shagun Singh Chadha, Wells Fargo Securities, LLC, Research Division - Associate Analyst [24]

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That's really helpful. And then I just wanted to get an update on pricing. It looks like Teleflex is in price discovery mode for a few key products. For MANTA, it appears that price may be settling in at about $800 to $1,000 range, even though our checks have suggested that price is the biggest barrier to adoption. And you've seen some pushback from value analysis committees at hospitals for Percuvance. So can you just give us your take on what does the pricing environment look like currently? And just comment on your ability to achieve the desired level of pricing.

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Liam J. Kelly, Teleflex Incorporated - President, CEO & Director [25]

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Thank you. So regarding the MANTA pricing, that would not come through in pricing as of yet because it's a new product. That total sale of that would be seen for us as a new product.

But regarding your comment on general pricing, Teleflex has always been a pretty unique medtech company, insofar as that we have an internal discipline around pricing and that was no different in this quarter.

We saw in this quarter, positive pricing in around the 40 or 50 basis points range, which gets us to a year-to-date pricing positive of above 30 basis point. So we continue to see this as a strength in the Teleflex portfolio. And also in the discipline within our commercial organizations to continue to be able to take pricing in certain geographies and within certain product categories on an ongoing basis.

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Operator [26]

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And our next question comes from Raj Denhoy with Jefferies.

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Anthony Charles Petrone, Jefferies LLC, Research Division - Equity Analyst [27]

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This is Anthony for Raj, actually. Two questions. Congrats again on the quarter and all the progress here so far.

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Liam J. Kelly, Teleflex Incorporated - President, CEO & Director [28]

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Thank you.

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Anthony Charles Petrone, Jefferies LLC, Research Division - Equity Analyst [29]

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The first one would be on UroLift and the second, actually on Interventional Access. So just on UroLift, can you give us a sense, there's a lot of drivers here right now in the U.S.? And so AUA last quarter, there was some clinical data obviously you mentioned, Liam, favorable reimbursement events in the quarter, but also a competitor had some reimbursements sort of shift against them. So when you look at all of those drivers, how -- is there anyone that's kind of leading the charge here?

And then on Interventional Access, actually to dig in specifically to the intra-aortic balloon pump business, there seems to be a lot of moving parts in that market right now. So Datascope recently had a recall, and then Abiomed on the Impella side has seen some headwinds in their business. So any color on the balloon pump business would be helpful.

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Liam J. Kelly, Teleflex Incorporated - President, CEO & Director [30]

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Yes. So we were aware of a competitor recall that started with balloon pumps. We were aware that they had a recall on their product. Now in many instances for capital equipment, we wouldn't expect to see a massive benefit in that. I will say though that our intra-aortic balloon pump business continued to have a very solid second quarter off a very solid first quarter. And we were very pleased with the growth in that. And we have a new pump on the market. And regardless of what's happening with the competitor regarding a recall or anything, which wouldn't have really flown through in the second quarter, we continue to take share with that new pump on a global basis. And the good thing about the balloon business was it was pretty broad-based. There was solid growth in the Americas. There was solid growth within the EMEA and also within Asia. So we feel good on the balloon pump and a very solid performance.

Regarding your question on the UroLift, I've always said it, Anthony, clinical data, patient outcomes will win 7 days a week and twice on Sundays. So -- and that will continue. And we just have better clinical data.

The reimbursement issue with regard to the competitor, that hasn't flushed through yet either. That's just a guidance or a -- and a -- their expectation for the reimbursement. That won't come to be -- to fruition until the third or fourth quarter, around there. So that couldn't have an impact.

In all honesty, what's driving our product is it's better for the patient, it is reimbursed well, but it's better for the patient to get better patient outcomes. We have a world of clinical data. We have excellent coverage. We have every life in the U.S. practically covered now, as per my prepared remarks. And I think we're well on the way to have it be the retreatment for BPH. And I think that it -- we are working and we are focused on making UroLift the treatment for BPH. And as we move in from the early adopters to the fast followers and we couldn't be happier with the performance of the product.

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Operator [31]

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Our next question comes from Matt O'Brien with Piper Jaffray.

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Kevin Michael Farshchi, Piper Jaffray Companies, Research Division - Research Analyst [32]

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This is Kevin Farshchi on for Matt. Congrats on other great quarter. Two quick ones from me on MANTA. It sounds like the first 3 months of the market release have been successful. Curious, one, what is some of the specific feedback that you've been hearing?

And then secondly, you reiterated no material revenue in '19. Can you parse out some of what's holding back commercializing the product a bit faster? I'm thinking about the tailwinds we see in the TAVR market specifically. And then you mentioned it gets more meaningful in 2020. Can you quantify that; what contributions might look like to your growth rate?

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Liam J. Kelly, Teleflex Incorporated - President, CEO & Director [33]

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Thanks, Kevin. Thanks very much. So as I prepared -- as I mentioned in my prepared remarks, we did begin the U.S. limited market release in quarter 2 and, of course, we're getting very positive feedback. The level of feedback is in line with the clinical study we just published, which is showing a real short time to hemostasis, which is important for the doc where they're getting down to 23 seconds as compared to 6 to 10 minutes. And also seeing the reduction in major complications.

On the test market sites that we worked on, we have had a very, very high reorder rate from those test sites, which is proving to us that the product is sticky. We are getting it through the back without too much complications to be honest, simply because the product has such clinical evidence behind it. And the interventional has seen there's a need for the product.

The reason that we don't see significant uptick in revenue in the -- that business unit from this product is because we have a divestiture going on at the same time within that business unit where we divested the vein reprocessing business.

And regarding your question about guidance for 2020, if you don't mind, Kevin, we'll hold that until we do give 2020 guidance, and we'll include some specifics around MANTA in that guidance that we give.

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Operator [34]

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And our next question comes from Kristen Stewart with Barclays.

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Kristen Marie Stewart, Barclays Bank PLC, Research Division - Research Analyst [35]

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My first question is just kind of around the growth guidance for the second half of the year, especially considering, I think, you have an extra selling day in 4Q. I guess what would be some of the things that you would expect to be contributing to a deceleration in the growth rate again, considering 4Q should, in theory, have a little bit of a benefit from the selling day comp? And then I have a follow-up.

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Liam J. Kelly, Teleflex Incorporated - President, CEO & Director [36]

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Yes. Thanks, Kristen. So really, there are a number of aspects and a number of new moving pieces here. First of all, in the first half of the year, we had an easier comp comparison. As you get into the second half, I think we grew by 5.6% and 7.7% in the Q3 and Q4 last year, which is a tougher comp. But what I think, Kristen, is very, very encouraging that we've put out guidance that has been growing approximately or very close to that 7% range even with those tough comps. So this is a portfolio that we have been trying to build to have a portfolio of products that can sustain the distributor movement as we saw in quarter 1. But also be able to be really confident in growing at that 6% to 7%, even in a tougher comp environment that we're going to face next year. So that's the encouraging thing from our standpoint.

Also as we said, OEM and Interventional Access came out of the blocks really quick in quarter 1. And we didn't anticipate them maintaining that level of growth. So therefore, one would anticipate that they would be a little bit lighter in the back half.

And on the positive side of the ledger, I guess, we will see that perhaps Anesthesia and EMEA might do a little bit better in the back half. And obviously we've taken up our guidance for UroLift to 35%, and that business continues to do incredibly well. If we can continue to invest behind it, which we have been doing and it is working, perhaps, that is an area that might help us again as we go through the year and into next year.

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Kristen Marie Stewart, Barclays Bank PLC, Research Division - Research Analyst [37]

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Right. Perfect. And then I was wondering if you could just provide a little bit more detail on what you had said about strengthening the IP portfolio and what that exactly means. I'm not sure if you're facing any sort of IP litigation or anything in that regard. Maybe just flush out that commentary a little bit more.

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Liam J. Kelly, Teleflex Incorporated - President, CEO & Director [38]

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Yes. What we've seen in the marketplace from time to time is smaller companies that would perhaps be, we would believe, infringing on some of our IP. And obviously, we will protect and as our investors would expect us to do, we would protect our valid rights to sell products that we invented and not allow copycats into certain markets.

So we are also spending some significant dollars on the other side of the ledger, reinforcing our IP and making sure that we're filing IP. We have a number of new products in the pipe that are in our mind pretty exciting, and we're trying to get broad coverage from IP protection within the landscape so that in the future, these products, as we run them through our pipeline, will be significant generators of revenue growth for us in the future. So that's the 2 aspects of that.

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Kristen Marie Stewart, Barclays Bank PLC, Research Division - Research Analyst [39]

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Is there anything on the IP side related to UroLift?

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Liam J. Kelly, Teleflex Incorporated - President, CEO & Director [40]

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I don't want to go into specifics. And please, Kirsten, don't go through our whole product portfolio. But that is not one that we're defending. It is one that we filed, though in order to protect for future.

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Operator [41]

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And our next question is from Matthew Mishan with KeyBanc.

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Matthew Ian Mishan, KeyBanc Capital Markets Inc., Research Division - VP and Senior Equity Research Analyst [42]

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A nice lead-up to my question, which is Medtronic released a product in the quarter that looks similar to GuideLiner. Is this something you consider to be a competitive product? And something that maybe is coming close to your patents?

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Liam J. Kelly, Teleflex Incorporated - President, CEO & Director [43]

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So I guess you're talking about the Telescope?

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Matthew Ian Mishan, KeyBanc Capital Markets Inc., Research Division - VP and Senior Equity Research Analyst [44]

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Yes.

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Liam J. Kelly, Teleflex Incorporated - President, CEO & Director [45]

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We were aware of that. It's -- and we've seen it in some of the markets and then in due course, we'll address it with the appropriate response, Matt.

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Matthew Ian Mishan, KeyBanc Capital Markets Inc., Research Division - VP and Senior Equity Research Analyst [46]

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Okay. Fair enough. And on RePlas, I guess expedited approval sounds better to Congress than it does to the FDA. But what do you think that the time frame looks like now on the BLA submission?

And then also can you comment on like the timing of the potential build-out of manufacturing infrastructure ahead of this submission as well?

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Liam J. Kelly, Teleflex Incorporated - President, CEO & Director [47]

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Yes. Let me deal with the manufacturing infrastructure, Matt, first, The manufacturing infrastructure is already built. We have enough lyophilizers in our current facility to address the demand from the total military demand and a portion -- a significant portion of the civilian demand. I will say on the EZPlas and I mentioned this in my prepared remarks. The collaboration with the FDA has been very constructive. The issue here is that both the FDA, Teleflex and military are incredibly excited about it because they see this product can have a positive impact on humanity. And we're all marching the same direction, but we are in uncharted waters here. A product like this has never been approved before.

We have some additional testing to do, Matt, and we will give further updates. It would be, I think, not appropriate to give you an expected time line. We're going to run some tests between -- over the next couple of quarters and once we have that test results back, I think then we'll be able to give you a much clearer view as to when we expect to do the BLA submission.

I will say though that the FDA are working hand in glove with us and with the military to get this through. We've already agreed a protocol for pediatrics. Pediatrics were never a requirement for fresh-frozen plasma, so we got that milestone done and many other milestones as we work with them. And we will give further updates on subsequent calls, Matt, as we go through this testing analysis that we need to do.

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Operator [48]

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And our next question comes from Mike Matson with Needham & Company.

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Michael Stephen Matson, Needham & Company, LLC, Research Division - Senior Analyst [49]

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Just a couple product, I guess, related questions. So can you just remind us why the transition to UroLift 2 is going to take as long as it is?

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Liam J. Kelly, Teleflex Incorporated - President, CEO & Director [50]

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Thanks, Mike. One of the main reasons is because we don't want to disrupt the growth. And we want to be thoughtful about the rollout of the UroLift 2 within the United States. So we want to ensure that we do it in a thoughtful way so that our sales talent can continue to serve its existing accounts, bring on new accounts and then transition new and existing accounts to UroLift 2. I think it would be almost foolhardy to go too aggressively after this and disrupt the growth.

Don't forget we are -- last year, we did $200 million in a big $1 billion market in the United States. And the last thing we want to do is to disrupt that growth. It is one of our 5 that drives and it's our most important one of the 5 that drives. So we're going to keep a very close eye on it.

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Michael Stephen Matson, Needham & Company, LLC, Research Division - Senior Analyst [51]

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Okay. And then just Percuvance. I didn't hear that you called that out as one of the things that drove the surgery business, so just curious where things stand with that?

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Liam J. Kelly, Teleflex Incorporated - President, CEO & Director [52]

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Yes. Thanks, Mike. We're still on limited market release, and we will be on, as we said previously, on limited market release through the end of the year. We'll give further updates on Percuvance as we get into guidance for 2020 when we should then come either to an extended limited market release or a full market release. But everything is going according to plan, Mike, is what I can say with Percuvance.

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Operator [53]

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And our last question is from Brian Weinstein from William Blair.

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Brian David Weinstein, William Blair & Company L.L.C., Research Division - Partner & Healthcare Analyst [54]

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So outside of UroLift, I'm curious how much of the growth do you think in the first half is from actual gains versus segment market conditions? In other words, what do you see as kind of market growth in your key segments right now? And where do you think you're specifically taking the most share?

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Liam J. Kelly, Teleflex Incorporated - President, CEO & Director [55]

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Brian, excellent question. So I would say, if I went through the various business segments, if I went through Vascular Access, let me start at the top of the house, Vascular Access, through the first half of the year, as I said, we grew over 7%. For sure that market is growing in the 2% range. So clearly, we're taking share. The areas we're taking share is in -- is for sure within the PICC part of our portfolio where we have an antithrombogenic and antimicrobial PICC. And also we continue to develop the markers with the EZ-IO, which also takes share.

Interventional Access through that half year, as I said earlier, at almost 13%, and that's clearly a share gain also. That market would be growing in that 4% or 5%. Surgical is again above market, so you have to be taking share. Interventional Urology, we're creating a new category. So we're moving patients that would be taking pharma into another area. OEM is again an area that's growing above market where we're taking share.

Anesthesia is probably the one where it's not taking share and it's growing maybe modestly below the market in the first half of the year. But again, they've been through some destocking and that's the one area where we didn't see the restock. There's a little bit of modest restocking sitting in Anesthesia that may come back.

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Brian David Weinstein, William Blair & Company L.L.C., Research Division - Partner & Healthcare Analyst [56]

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Great. And then on the DTC stuff with UroLift. Can you start to quantify the benefits that you're seeing there or give us any metrics on how that is rolling out? And how you intend to expand that program to help drive UroLift going forward?

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Liam J. Kelly, Teleflex Incorporated - President, CEO & Director [57]

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Yes, I can give you details on how we're expanding it. So last year, we did 6, this year we will do 12. If it continues to drive accelerated growth, Brian, we might even add a few more at the back end of the year. So through the first quarter, we initiated 7 of the 12. So it's clearly working. We get great response. And we're very encouraged by it.

We do see -- if we compare the DTC market to the controlled market of a similar size, we do see a significant uptick in customers going -- on patients who now know what the condition they have is called. So many patients that are just getting up 8, 9 times a night driving their wife or spouse crazy. And now they see the advertising campaign, they listen to it, we hit them on Facebook, and they now can put a name to what has been causing their condition and they go to their urologists and they have a conversation. And then the urologist will define what's the best path for that patient. So working very well. And we're very excited by it, Brian, I think is the headline.

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Operator [58]

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And this concludes our Q&A session for today. I would like to turn the call back to Jake Elguicze with his final remarks.

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Jacob P. Elguicze, Teleflex Incorporated - VP of IR & Treasurer [59]

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Thanks, operator, and thanks to everyone for joining us on the call today. This concludes the Teleflex Incorporated Second Quarter 2019 Earnings Conference Call.

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Operator [60]

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Thank you, ladies and gentlemen, for participating in today's program. You may all disconnect. Have a wonderful day.