Teleflex Incorporated (TFX) Q4 2020 Earnings Report, Transcript and Summary

Ladies and gentlemen, thank you for standing by and welcome to the Q4 2020 Teleflex Incorporated Earnings Conference Call. [Operator Instructions]. I would now like to hand the conference over to your speaker today, Mr. Jake Elguicze, Treasurer and Vice President of Investor Relations. Thank you. Please go ahead, sir.

Thank you. Good morning, everyone, and welcome to the Teleflex Incorporated Fourth Quarter 2020 Earnings Conference Call. The press release and slides who 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 855-859-2056 or for international calls 404-537-3406 passcode 8789956. 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&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 our press release today, as well as our filings with the SEC, including our Form 10-K, which can be accessed on our website. Additionally, during this conference call, you will hear management make references to the estimated positive or negative impact that COVID-19 had on our operations during the fourth quarter and full-year of 2020. You'll also hear management make statements regarding intra-quarter business performance during the first quarter of 2021. Management is providing this commentary to provide the investment community with additional insights concerning trends and these disclosures may not occur in subsequent quarters. With that said, I'd like to now turn the call over to Liam.

Thank you, Jake, and good morning, everyone. It's a pleasure to speak with you today. Before I get into the details of our quarterly performance, I'd like to once again offer my sympathies to anyone who has been impacted by COVID-19 as well as my sincere thanks to all the healthcare workers who continue to put themselves at risk to battle this each day. I'd also like to take a moment to again recognize the Teleflex employees around the world. This past year has been challenging, but our team has done a tremendous job serving our customers and patients globally, overcoming obstacles to manufacture and distribute our products to the people that need them most. Thank you. Now turning to our results. Considering the volatile environment we operate in, we are pleased with our Fourth quarter performance as our business did better than we expected and trends continued to improve across many of our product categories and geographies. We saw better-than-expected sequential improvement from quarter to 2 quarters and from quarter 3 to quarter 4. Despite a rising number of COVID-19 infections that occurred throughout the fourth quarter, the recovery in our business was led by product lines that were initially most negatively impacted by COVID-19, those being our Interventional Urology, Interventional Access and Surgical businesses as well as continued strength within our Vascular Access and other product categories. While from a regional perspective, we saw strength within the Americas as well as positive growth within EMEA and improving trends in Asia. Quarter four revenues totaled $711.2 million, which represents an increase of 2.3% as compared to the prior year period on a constant currency basis. Growth in the quarter was aided by 2 additional selling days, which we estimate contributed approximately 3% points. Excluding the impact of the additional selling days, we estimate that our constant currency revenues declined approximately 1%. The day's adjusted declines reflect continued recovery progression relative to the 4% decline we experienced during the third quarter of the year and the 12% decline we experienced during the second quarter of the year and it was ahead of the expectations we had at the time of the third quarter earnings call. During the fourth quarter, we estimate that headwinds associated with COVID-19 caused a net negative impact of approximately $61 million or approximately 9%. If we were to normalize for the negative impact, we estimate that our underlying business grew by approximately 11% on a constant currency basis, or 8% when normalizing for the selling day impact. In addition to seeing continued sequential improvements in our constant currency revenue performance during Q4, we also saw a significant sequential improvement within our adjusted gross and operating margins as compared to the second and third quarters of the year. This improvement drove adjusted earnings per share, which exceeded our internal expectations. Lastly, I am happy to announce that on December 28th, we closed the acquisition of Z-Medica a market leader in hemostatic products. We are pleased to be able to deploy capital for a differentiated product portfolio that leverages the existing Teleflex call points and is immediately accretive to our revenue growth rates, adjusted gross and operating margin profile and our adjusted earnings per share. Turning to a more detailed review of our fourth quarter results. As I just mentioned. Quarter four revenue grew 2.3% on a constant currency basis and 4.4% on an as reported basis. The increase in revenue was driven by our Vascular Access Portfolio, which saw some tailwinds in terms of COVID- related purchasing and solid mid-single-digit growth of Interventional Urology and our other segment. From a margin perspective, we had generated adjusted gross and operating margins of 58% and 26.6% respectively. This translated into a year-over-year declines of 120 basis points at the gross margin line and 50 basis points at the operating margin line. However, from a sequential standpoint, this represented an improvement of AZ and 150 basis points respectively compared to quarter three levels. On the bottom line, adjusted earnings per share was $3.25. Overall, our financial performance in the quarter demonstrates the sustained resilience of our diversified global product portfolio and it gives us confidence in our ability to achieve our long-term financial objectives once we get past COVID-19. Let's now turn to a discussion of our quarterly revenue trends, which will be on a constant currency basis. The Americas delivered revenues up $419.5 million in the fourth quarter, which represents an increase of 5% over the prior year period. Growth within the Americas was driven by Vascular Access and respiratory products which both saw elevated demand driven by COVID. In addition, Interventional Urology was a strong contributor as UroLift continues to be our fastest recovering procedure. However, there were offsets with declines in other product categories. We estimate that the Americas would have grown approximately 12% excluding the impacts that COVID-19 had on the region. EMEA reported revenues of $161.4 million in the fourth quarter, representing growth of 4.1%. During the quarter, EMEA benefited from a one-time order of tracheostomy products and from the extra selling days, the combination of which more than offset our estimated 1% COVID headwinds. Turning to Asia. Revenues totaled $78.6 million in the fourth quarter, which represents a decline of 7.2%; however, we estimate that we would have had positive constant currency revenue growth in the mid-single digits, if not for the impact of COVID-19. Additionally during the fourth quarter, we finished transitioning a distributor in Japan. When normalizing for both COVID and the distributor change, growth in the region would have been in the mid to high single-digit range. And lastly, our OEM business reported revenues up $57.7 million in the fourth quarter, which was down 6.9% on a constant currency basis. As we anticipated during the fourth quarter, our OEM business saw aligned impact related to COVID relative to our other businesses. Investors familiar with Teleflex will be aware that our OEM business supplies device companies with complex catheters and surgical sutures and the quarter four impact reflects reduced orders from these customers whose business is tied to non-emergent procedures. Excluding the impact COVID-19 had, the business grew roughly 31%, which includes a benefit of approximately 13% from the acquisition of HPC. As it relates to HPC, I am pleased to report that we remain on track with our integration efforts. Let's now move to a discussion of our revenues by global product category. Starting with Vascular Access, fourth quarter revenue increased 16% to $182.5 million. We estimate that COVID-19 positively impacted the growth rates of our vascular products during the fourth quarter by approximately 5%. Key drivers of revenue growth included PICC, which increased approximately 20%, CVCs which increased approximately 16% and EZ-IO which grew approximately 14%. Moving to Interventional Access, fourth quarter revenue was $106.7 million or down 6.9% as compared to the prior year period. The decrease was largely due to the delay in the recovery of certain non-emergent procedures because of COVID 19 along with the negative impacts stemming from a catheter recall and distributor conversion in Japan, both of which began last quarter. We estimate that the recall and distributor issue impacted our business negatively by approximately $3 million. We expect the impact on the recall to continue to linger for the next few quarters as we do not expect to be back on the market with this product until September of this year while the distributor inventory headwind should reverse and be a modest tailwind for us in 2021. When normalizing for the impact that COVID had along with the aforementioned headwinds, we estimate that underlying growth was in the high single digits consistent with our long-term growth outlook for the segment. In addition, we are pleased that Manta grew 33% globally in quarter four. Now turning to Anesthesia, revenue was $86.1 million, which is lower than the prior-year period by 2.1%. The revenue decline was the result of lower sales of laryngeal masks and endotracheal tube products. We estimate that COVID had an approximate 1% negative impact in the quarter, implying flattish performance on an underlying basis. Since we closed the Z-Medica acquisition just days before year-end, its impact was immaterial on quarter four results. Shifting to Surgical. Revenues declined by 5.7% to $92.3 million driven by lower sales of our ligation portfolio. We estimate a 9% headwind from COVID during quarter 4 indicating recovery as compared to the estimated 13% COVID headwind in quarter three. Moving to Interventional Urology. Quarter four revenue increased by 5.3% to $93.9 million, which represents a new high watermark in terms of revenue dollars in any given quarter. On a year-over-year basis, the business faced a difficult growth comparison but sequentially, it grew by 15% versus quarter three. We estimate an approximate 28% COVID-19 related headwind during quarter four. Notwithstanding the significant headwind on our growth in quarter four, we are pleased with the path to recovery for this business unit and are also happy with the impact of the national DTC campaign, which is exceeding our expectations. Additionally, we are encouraged that we trained approximately 130 new urologists in quarter four moving to a cadence that is consistent with our expectations prior to COVID and a positive leading indicator for future growth. And finally, our other category, which consists of our respiratory and urology care products grew 6.1% totaling $98.1 million. We estimate the growth during the quarter was partly due to increased demand for certain humidification and breathing products resulting from COVID-19 mainly in the Americas. That completes my comments on quarter four revenue performance. Turning to some recent clinical and commercial updates. Starting with UroLift, the response to our national DTC campaign is exceeding our expectations. The strategic role of DTC is important as about half of the 12 million men being treated for BPH believe prescription medications are their only solution. Overall, we view the pilot national DTC as a successful campaign. Key statistics include a doubling of brand awareness among men age 45 are higher post campaign versus pre-campaign levels. Approximately 150% increase in visits to UroLift.com during the campaign and direct response numbers that exceeded our internal projections by a wide margin. Lastly, we know that Google search trends demonstrate a significant and sustained increase in response to the campaign. As such, we expect to continue the national DTC effort in 2021 and beyond. Turning to UroLift too. We have completed the market acceptance test and received positive feedback across more than 100 procedures completed by 20 urologists. We have begun a full controlled launch. The launch is controlled due to restrictive access caused by COVID-19. This will ensure we don't disrupt growth recovery with a more fulsome rollout beginning in the second half of 2021. We remain confident that conversion to the UL2 will occur over time and we continue to expect to generate significant margin expansion as the revenue base is fully converted. Regarding Japan, we remain on track for reimbursement decision in 2021 and view the approximate $2 billion addressable market as an incremental growth driver that will be a positive catalyst for seeable future. Overall between nationwide DTC, Japan rollout, and the launch of UL2, we have multiple drivers to build momentum as we seek to further expand our leadership position in BPH. Turning to the next slide on key clinical updates. Recently a comparative analysis of sexual function outcomes from UroLift studies and the Medical Therapy of prosthetic symptoms trial was published in the peer-reviewed journal European Urology Focus. The comparison reveals that UroLift is superior to BPH medical therapy in preserving erectile and ejaculatory function and sexual satisfaction. Importantly, this study challenges the idea that medical therapy is the most conservative treatment option for BPH. Over time, we believe that more clinical research like this publication consider UroLift as a first-line therapy for treating BPH. Turning to an update on Interventional Access. Regarding the CTO-PCI study that we mentioned on our Q2 earnings call, I am pleased to announce that we have completed enrollment for this study. This is a prospective, single-arm IDE study of 150 patients across 13 sites to evaluate the performance of the entire range of Teleflex coronary guidewires and specialty catheters in chronic total occlusion percutaneous coronary intervention procedures, which is the most demanding PCI environment. Once the study results are finalized, we anticipate updated labeling for our Guidewire and Specialty Catheter products which can address an estimated 100,000 CTO-PCI procedures. Overall, we continue to invest in clinical and commercial catalysts that will help to sustain our upper single-digit revenue growth aspirations in a normalized environment. Lastly, turning to EZPlas. I am happy to update the investment community that we successfully submitted our BLA to the FDA in late January. We recently performed a market assessment update and still see a $100 million initial market opportunity for EZPlas. We are increasingly confident in our ability to address this commercial opportunity with revenue likely ramping in early 2022. In addition, we believe there are potential revenue synergy opportunities with Z-Medica to leverage their sales reps as well as our channel strength across the healthcare and government call points which could add to our baseline expectations, which brings me to an update on our latest acquisition. On December 28th, we completed the acquisition of Z-Medica, an industry leading manufacturer of hemostatic products that is a classic Teleflex deal and a great strategic fit. Investors familiar with Teleflex will be aware that we aim to invest in innovative products and technologies that can meaningfully enhance clinical efficacy, patient safety and comfort, reduce complications, and lower the overall cost of care. Given their differentiated products and attractive end markets, we view the Z-Medica acquisition like that of Vidacare from a few years ago. Since we acquired Vidacare in 2013, we have more than double the sales which are still growing in the healthy double-digit range. One difference is that Z-Medica is growing into a $600 million addressable market while Vidacare is addressable market was closer to $250 million. Regarding our long-range financial targets. Z-Medica only reinforces our ability to get to those goals, and we remain committed to delivering constant currency revenue growth of at least 6% to 7% on an annual basis and reaching 60% to 61% and 30% to 31% adjusted gross and operating margins once we return to a more normalized environment. We plan to hold an Analyst Day event in the fall of this year, at which time we intend to provide updated long-term financial goals and timetables. This completes my prepared remarks. Now I would like to turn the call over to Tom for a more detailed review of our fourth quarter financial results. Tom?

Thanks, Liam and good morning, everyone. Given the previous discussion of the company's revenue performance, I'll begin with the gross profit line. For the quarter, adjusted gross margin was 58%, a decrease of 120 basis points versus the prior year period. The decrease in gross margin was primarily due to COVID-related impacts, including unfavorable product mix and higher manufacturing costs along with a modest foreign exchange headwind. In total, we estimate that COVID negatively impacted our adjusted gross profit by approximately $44 million in the quarter. We continue to tightly manage discretionary spending, partially offset the reduced revenue and gross profit resulting from COVID. As a result of the efforts, we estimate that operating expenses were reduced in the fourth quarter by approximately $13 million. For full-year 2020, we managed OpEx lower by an estimated $78 million. Fourth quarter operating margin was 26.6%, were down 50 basis points year-over-year. Continuing down the income statement. Net interest expense totaled $18.5 million, which is an increase of 10% year-over-year and reflects higher average debt balances versus the prior year period due to the acquisitions of HPC and Z-Medica. Moving to taxes, for the fourth quarter of 2020, our adjusted tax rate was 10.1% as compared to 7.7% in the prior year period. At the bottom line. Fourth quarter adjusted earnings per share declined modestly to $3.25 from $3.28 a year ago. Included in this result is an estimated adverse impact from COVID of approximately $0.55 and a foreign exchange tailwind of approximately $0.05. Turning to select balance sheet and cash flow highlights. In 2020, cash flow from operations was flat as compared to 2019 totaling $437.1 million. We are pleased with this outcome given COVID headwinds and increased contingent consideration payments that flowed through cash flow from operations in 2020 as compared to 2019. Overall as we exited 2020, the balance sheet remains in good shape. At year-end, our cash balance was $375.9 million as compared to $301.1 million as of December 2019. Over the course of the year, we deployed more than $750 million for external business development opportunities. We'll continue to balance our investments across both organic, inorganic initiatives to fuel our growth and drive margin expansion with M&A as our primary focus for capital deployment. Inclusive of Z-Medica financing, we net leverage ended 2020 at 2.98 times, which remains well below our 4.5 times covenant. Lastly, we have no near-term debt maturities of material size. In summary, despite facing the challenging operating environment during 2020, the organization adapted quickly and executed well. We remain optimistic toward the future and expect to recovery beginning in the second half of 2021. As such, we are reinstating financial guidance for 2021. To begin, I'll provide a framework of key assumptions underlying our financial guidance. Our outlook contemplates COVID disruption continuing through much of the first half of the year, with the second half of the year much closer to a normal operating environment. Our baseline assumption assumes that healthcare systems can manage through incremental COVID surges while applying past learnings to avoid widespread procedure shutdowns. It also excludes any material regulatory, healthcare or tax reforms, as well as any future M&A. Lastly from a selling day perspective, we will have 2 fewer selling days in the first quarter as compared to the year-ago period, we will have one additional day in the 4th quarter as compared to the year-ago period, and there will be no differences in the number of days during the second and third quarters. In 2021, we project constant currency revenue growth between 8% and 9.5% as compared to 2020. We expect our Interventional Access, Surgical and Vascular Access product offerings to be key contributors to our constant currency revenue growth during 2021. We also expect our Interventional Urology business to increase at least 30% over 2020 levels. Additionally, Z-Medica is expected to contribute $60 to $70 million of revenue or approximately 2.5 points of growth. Turning to currency. We expect foreign currency exchange rates will be a tailwind to revenue growth of approximately 2%. As a result, we expect our as-reported revenue to increase between 10% in 11.5% over 2020 and this would equate to $1 range of between $2.791 million and $2.829 million. Turning next to gross margin. During 2021, we anticipate that adjusted gross margin will increase between 130 and 230 basis points to a range of between 8% and 59%. We expect gross margin expansion will be driven primarily by a favorable mix of high margin products primarily, Interventional Urology as well as the acquisition of Z-Medica which will add approximately 50 basis points to gross margin. Moving to adjusted operating margin. During 2021, we anticipate that adjusted operating margin will increase between 110 and 210 basis points to a range of between 26% and 27%. The increase in adjusted operating margin will be sourced from the gross margin expansion, partially offset by normalization of certain 2020 COVID-related spending reductions, which were temporary in nature as well as further strategic investments into UroLift and Manta. Additionally, the acquisition of Z-America is expected to provide a modest tailwind to year-over-year operating margin expansion. Given the relatively higher OpEx cost structure of Z-Medica versus Teleflex, operating margin accretion from Z-Medica will be less than the 50 basis points of gross margin accretion. That takes me to our adjusted earnings per share outlook for 2021. This slide serves as a bridge for our full-year 2020 adjusted EPS results to our full-year 2021 adjusted EPS outlook, beginning with the 2020 adjusted EPS of $10.67. From an operating standpoint in 2021, we project additional earnings between $1.58 and $1.66 per share or an increase of approximately 15%. Our 2021 EPS guidance also assumes the following: Foreign exchange has planned recent spot rates for key currencies including a full-year euro to dollar exchange rate of $1.21. For 2021, foreign exchange is expected to provide a tailwind of approximately $0.35. We now project Z-Medica to contribute between $0.21 and $0.26 of adjusted earnings per share in 2021, and this is an increase from our original expectation, which call for contribution of between $0.07 and $0.15. The increase in the Z-Medica accretion is due to the change in our planned approach for financing the acquisition, which we now believe to be done through a combination of borrowings under our revolver and free cash flow versus a previous expectation for bond offer. Turning to interest. In 2021, we expect interest expense to range between $63 and $65 million/. The year-over-year reduction in interest expense is expected to contribute between $0.17 and $0.19 of earnings accretion if you would exclude the incremental financing costs for Z-Medica. Moving to taxes. During 2021, we project that our adjusted tax rate will be in the range of 13.5% and 14% and will result in adjusted earnings per share headwind of between $0.33 and $0.38. The projected year-over-year increase and the adjusted tax rate is a result of a greater expected mix of U.S. taxable income principally resulting from UroLift growth and certain 2020 tax benefits that we do not expect to reoccur in 2021. Additionally, our assumption is that 2021 windfall benefit from stock based compensation is at a reduced level versus the typically high level realized in 2020. We estimate that weighted average shares will increase to $47 million for full-year 2021 which is diluted by approximately $0.10. Despite several headwinds, our adjusted earnings per share outlook of $12.50 to $12.70 is robust, representing growth of between 17.2% and 19% versus 2020. Given the expectation of continued COVID impact into 2021, I'll highlight some considerations regarding quarterly expectations. As I mentioned previously, our outlook is predicated on the assumption that COVID will continue to cause disruption during the first half of the year with a particular negative impact during the first quarter. Additionally, the first quarter of 2021 has few fewer selling days as compared to 2020. As a result at the midpoint of our guidance ranges, we expect to realize approximately 22% of full-year as reported revenue, and approximately 19% of our full-year adjusted earnings per share during the first quarter of 2021 and that concludes my prepared remarks. I would now like to turn the call back to Liam for closing commentary. Liam?

Thanks, Tom. In closing, we delivered solid fourth quarter results as our diversified portfolio showed continued improvement relative to the second and third quarters of the year on both the top and bottom lines. Excluding the impact of COVID, we see our underlying business performance as encouraging and while the next several quarters still will have elements of uncertainty, we remain confident in our ability to execute in 2021 and are up and we'll continue to focus on serving our hospital customers and working with our key stakeholders. We are excited about the prospects for our business. We have several revenue drivers including UroLift, Manta, Z-Medica, PICC, Vidacare, EZPlaz and HPC to name but a few. We will manage the business prudently while staying focused to capitalize on the long-term potential of our global product portfolio. In closing, I want to thank our 14,000 employees around the world who continue to manufacture, distribute and support products that are required in the fight of COVID-19 and who came together exemplifying our culture and core values by staying true to our purpose to improve the health and quality of people's lives. As an organization, we remain well positioned to create value for all our stakeholders. That concludes my prepared remarks. Now I would like to turn the call back to the operator for Q&A.

[Operator Instructions]. Your first question comes from David Lewis with Morgan Stanley.

Great. Good morning. Thank you for taking the question, just one on guidance and then a follow-up for Liam on Urology. So, Tom, just to you two little small things on guidance here. Your topline, obviously you've kind of bit of low in the street but you're bracketing the street in bottom line. Assuming that reflects FX and Z-Medica. But can you sort of bridge us there a little bit because it's certainly reflect some opportunity on recovery and then what are you assuming in terms of recovery here as we head into March, now that we're at the end of February? And then a quick one from Liam sure.

So, as we built out our plan for 2021, our assumption is that we see levels in the marketplace in the first and second quarter somewhat similar to what we saw in the fourth quarter and then we expect to follow that recovery beginning in the third quarter, back to what we'd consider more normalized procedure levels in revenue growth rates. And then maybe just help me on the first part of the question again.

I'm sorry Tom, you're kind of guiding below the position in the top and in line with the street in bottom and I'm assuming that's more FX and Z-Medica financing, but obviously it reflects a lot of room on earnings. I just want to see if you could bridge stay a little bit, make sure that's accurate.

Well, I think that is the way to look at it that as we look at the guidance it does incorporate FX, Z-Medica into our guidance as well as some of the other factors that we've talked about.

And I think, David, if I just could add one comment on the topline guidance, we took a fairly prudent approach we believe to our guidance. September not seems a long time ago but when we identify the potential risk of the increasing COVID cases that had an impact in quarter 4, and in hindsight that was the correct call. Now we were a little bit on an island back then. But most of the market has come around, similarly with the uncertainty still remaining, we have been thoughtful as we look at our 2021 guidance. Some people might say, it's a little bit conservative to expect a recovery in the back half of the year, but I would prefer to be conservative right out of the gaze and to your point if we show it to be overly conservative that should also have an impact not only on revenue but on earnings per share for sure.

Okay, go head Tom.

If you just think about that EPS bridge when we look at the components of our growth, the growth is really coming from the strength of the operating performance. If you kind of bundle up the change in interest, taxes, shares and foreign exchange. They come pretty close to us to a wash. And then obviously you have a 25 cent pickup from Z-Medica. So, really as you think about what's driving that. It is the underlying performance of the business with kind of the non-operating items being close to wash in the aggregate.

Okay, super helpful. And then Liam just coming back here to Urology in NeoTract area. The COVID adjusted number for the third quarter is something around sort of 30% which is obviously a little lower than you saw in the second and third quarter. And I appreciate there's a lot of noise in these numbers with COVID, but if I think about sort of that 30% number for the fourth quarter, then I also think about the adding benefit of DTC offsets by resurgence. How should I think about that 30% adjusted number relative to the sort of 40% to 45% numbers we saw in the second and third quarter? Just help us understand underlying momentum and how you see that business into 2021. Thanks so much.

Your math is good. As the impact of COVID, it grew by at 33% and we were really pleased with the performance of UroLift. You got to put it in the context of what happened in the fourth quarter, David. We saw new variance of COVID, we saw COVID cases rising, we saw procedures getting canceled and quite frankly we were really pleased that we actually exceeded modestly, our internal expectations for the product. And I think it had a really tough comp 2 versus the prior year. If you remember last year we grew quite aggressively in the fourth quarter, I think it was up 52% in Q4. So, coming up against a tough comp, I think that was also a factor. And my own view on this is that with the rise in cases, I would have expected UroLift to miss our --. I believe that it didn't do so because of the offset of the DTC which supplemented that. So, I think we're in a pretty good shape with UroLift in regards to the recovery and we feel really confident of where we're at with it.

Great, thanks so much.

Cheers Mate.

Your next question is from Larry Keusch with Raymond James.

Thanks. Good morning, everyone.

Good morning, Larry.

Good morning, Liam. So, I guess, just coming back to UroLift and I know you guys talked a little bit about the philosophy on the '21 guide overall but maybe again talk about how you're approaching the guide for UroLift in '21, that 30% plus. How you kind of thinking about the cadence of that and what's assumed in that for revenues out of Japan. And then I had one on one.

Okay. So, start with the revenue at Japan. Larry, the revenues in Japan are minimal in our guide for UroLift. We do still anticipate that we will get a reimbursement decision as we head into Q2, Q3 and therefore be generating revenues in Japan, but it's fairly minimal within our within our current guide. What we would expect to see, Larry, and as you heard from Tom's prepared remarks with the cadence of revenue in Q1 that would lead you to the overall company revenue being that minus 1, minus 2-ish percent in Q1 because we've seen a rising number of cases after the holidays in January, that continued into February and UroLift would be in the similar bucket. So, the growth that we had in Q4 should be a little bit less in Q1, then you should see a continued recovery as we go into Q2 and Q3 and Q4, thereafter. The UroLift product does have an easier comp in Q2, but every Medtech companies is an easier comp in Q2. So, I think the rubber really hit the road, if I can use that expression, we get into Q3 and Q4 and we begin to ramp back up, COVID cases should be subdued, the vaccine should be rolled out at that stage and we should at that stage, then begin to ramp back up and I think it's, given that the product was flat year-over-year pretty much in 2020 to get an excess of that 30% growth back and that would also indicate that 30% growth on 2019 as well, Larry. So, are in excess, 30% growth versus 2019.

Okay, thank you. That's very helpful and then just the other quick question here is just on EZPlas-you reiterated that $100 million plus market. And it sounds like you went back into another look at that opportunity and still coming out in that range. I suspect that and correctly, if I'm wrong, that you're probably thinking about this as a late '21 FDA clearance. How do you see that revenue starting to impact 2022? How does that develop? Should we be thinking about Military orders being potentially lumpy and you develop the civilian market at the same time.

The beauty by doing a BLA submission, Larry, is that you get access to both civilian and military market. Now we start with the military in 2021 for sure because as you know they helped us develop the product and normal BLA submission is 9 months- approximately were on a fast track. Now, the FDA never tell you when the fast track ends and again in the area of prudence, we have incredibly modest revenue in the 4th quarter of this year for this product and we do expect it to ramp in 2022. Now, to answer your question on the cadence, it's a $100 million market. The military is $25 and so in 2022 will be focused on that military market and again I always caution investors, don't expect the military to place a $10 million order right out of the gate. It would be significantly, significantly less than but as we develop the market and as they roll it out it through special ops, through the CEOs into the general military, then we can pivot to the civilian market. And actually the biggest part of the civilian market, Larry, air ambulances because of the requirements for space and the adaptability of EZPlas to that environment and that's also something that was quite encouraging when we relooked at this market, that it's really two big segments, and then the rest are smaller segment. So, it's easier for us to focus. So, that's how we see it ramping as we go through ' 21 and into '22.

Okay, terrific. Thanks guys. I appreciate it.

Thanks, Larry.

Your next question comes from Shagun Singh with Wells Fargo.

Great, thank you so much for taking the question. One on guidance and one on Manta. With respect to guidance, can you let us know what you're assuming for backlog in that guidance by our math, it could be about 9% of sales? And I'm sure some of it's what may flow into 2022 and then on, Manta, could you comment on the lawsuit that was filed by Essential Medical relating to the missed sales milestone and payment by Teleflex following the merger, anything you can share with respect to your positioning, the size of milestone payment and next steps toward the resolution. Thank you for taking the questions.

No, absolutely. I'll start with the guidance question. So, our total revenue guidance of 10% to 11.5% does have assumed in a COVID recovery compared to prior year, but not a backlog or a bolus of procedures coming back other than that in the back half of the year. It's really difficult for us to estimate what that backlog would look like Shagun and also a difficult for us to assess whether hospitals will have capacity to put that backlog through. As we begin to recover, my view hasn't really changed on the geographical recovery. I still think it's going to be led by the Americas and Asia. And I think that Europe is definitely going to be the laggard. It is a source in the healthcare system and the way they're rolling out the vaccine right now does not appear to be in as aggressive as we see in other parts of the world. Regarding the Essential Medical losses that you mentioned, yes, we are aware of clearly and we are confident that we have acted appropriately and believe that the shoes is without merit, to be honest. We intend to vigorously defend ourselves in this matter and Shagun, you're familiar with the Manta product and you're familiar that we've invested heavily behind Manta with both clinical evidence and sales and marketing resources. And the product is a key revenue driver for Teleflex and performed well in the midst of the pandemic, growing over 30% globally in 2020 and growing by almost 90% in the key North American market and our plan this year is to continue to convert over 8% approximately of the large core market this year. And with regards to the question on the milestones. I mean there are contingent payment milestones contemplated in our financials and the total milestones is the matter of this dispute. But as I said we will fight it fairly vigorously. Shagun?

Thank you, so much. I'm all set.

Okay, thanks.

Your next question comes from Matt Taylor with UBS.

Hi guys, thanks for taking the question. So, the first one I wanted to ask was since we're coming up here on the launch of UroLift in Japan- you've given some parameters about the TAM at a high level and number of urologists things like that. I was hoping you could be a little bit more granular about the things that you can control in the rollout, like the pace of training, especially given we're still in a little bit of a COVID environment-how quickly should we see that uptake given the constraints that you have in the investment focus that you've?

So, what we've done, Matt, is that we have already preceded the market with market development specialists in Japan and we continue to engage. We've identified the top 20 urologists. Pre-COVID, we actually had a U.S. physician that spoke to Japanese in the country doing some peer to peer training. We also ran a virtual a BPH Summit and had a number of these 20 Japanese urologists. It came it to Reagan's trickle-down economics, but this is a trickle down urologists in Japan where we train at the top of the tree and these 20 our key that we've identified in order then to roll it out to the other urology practices and we have to do a mandated collection of data as part of our reimbursement. So, we will be doing that in the fourth quarter to gather that information and we are really enthusiastic and the other thing that is within our control, Matt, is to add additional sales reps. Now, we take the timing, it is going to work out really, really well for us because, Japan is another America where they are managing the buyers quite well now and they're starting to roll out the vaccine. So, we think as we get into Q3, Q4, we will be requiring access to train. We think the timing is going to work out pretty well for us and give us pretty broad access to the individuals we want to train. So, we did a pretty good about the ground work we've done to date, and we feel pretty good about the identification of the urologists that we need to train and there is a heightened level of knowledge about the UroLift because a lot of these Japanese urologists are very linked to the U.S. Urology Association. So, there is a heightened awareness of the product's availability and a desire to gain access to it. And once we get reimbursement, I think that's when we will really begin to ramp up our efforts.

Thanks. And I just have one follow, as we move into the next couple of years- are we going to see a similar pace of training of urologists in Japan as have in the U.S. by a couple of hundred a year? Can you talk about those plans in the intermediate term?

Yes. So, just remember there aren't many urologists. So, you would imagine it's going to be a little bit less, and also the market is a little bit smaller. And there are specialties in urology practice in Japan. So, if you take the 9,000 urologists, you'd have to imagine that about 5,000 or so are in the specialty we want to. So, that is less than half of what you have in the U.S. So, bear that in mind with the cadence, but in light of that data that's what I would expect a similar cadence and so if we train 400 to 500 in the U.S., you'd expect to train and half of that once you ramp up in Japan.

Okay, got it. Very good, thank you.

Thank you.

Your next question comes from Richard Newitter with SVB Leerink.

Hi, this is Erin, I'm for Rich. Just a quick one. Potentially, you guys mentioned for the main focus for capital deployment would be M&A. I was just wondering if maybe you could share some color on what kind of areas you're focusing on, and sort of and should we expect any larger deals or the classic tuck-ins?

So Erin, first of all, as Tom said in these commentary. We had a brilliant 4th quarter from the point of view of cash generation and deleveraging. So, we're down below 3 times again, on a net leverage basis. The type of assets first of all, the strategic element of our M&A strategy, our assets that fit within one of our existing channel portfolios are in alliance space. I mean we really like the cath lab for example. So, if we were to move into the neurovascular or peripheral vascular space in that similar call point that would be something that would be attractive. We also like technology that have IP, Z-Medica that we just closed, the IP runs out to 2033. So, that's, we like to protect the businesses. We look for assets that have a clinically differentiated product portfolio. We look for assets that create value in healthcare economics are in synergies in that respect. We also look for products that are sticky but we called sticky that get used over and over again, and again in the Interventional space, in the Vascular space, in the anesthesia emergency medicine space, in the men's health space and in the surgical space, so I think that's the beauty about Teleflex is we are looking in a broad area of places that's why we define these assets and also we're very disciplined in our approach and you can expect us to be continue to be disciplined. I can tell you, our pipeline is pretty full in this environment even in the midst of COVID. It is amazing to me how we're able to get some work done and we were able to close Z-Medica in the midst of COVID and now we're down below 3 and that would be even further reduced as we move through this year. So, we have got firepower and we are always looking and we continue to look right now.

Okay great things. And then just another quick one on Manta. You mentioned it grew over 30%. Could you just maybe talk about some of the trend you're seeing with our particular product and then maybe what it's kind of expected in 2021?

So, if you look at 2020. We converted at just over 5% of the market and we're contemplating converting 8% of the market approximately in 2021. So, that's the cadence that -that is in the midst of COVID. But I mean the trends we're seeing is it's being adopted pretty heavily in TAVR procedures, almost 90% of our cases today are still done in TAVR and that's the area, we're focused on. It's a $200 to $300 million market opportunity and we continue to ramp it up and we continue to have sales resources allocated to it and we're also planning to do some clinical work on the product and there are some enhancements that we also want to do on the product to make it even better than it is today. So, all in all we're really encouraged by the progress that we're making and we expect to continue to make progress in this year and into next year, this will be a multi-multi-year growth driver for Teleflex, and as we convert that market we a long runway ahead of us to convert.

Great, thanks so much.

Thanks, Erin.

Your next question comes from Anthony Petrone with Jefferies.

Thanks. A couple on UroLift and then I'll have one on Z-Medica. On UroLift, I'm just trying to get a sense of the totality of backlog that's building. Liam, the COVID is still running through so that that's a pressure point and on the demand push side you have DTC and so I'm just wondering if you can quantify the backlog of procedures that are building? And then as we look at the past couple of quarters, is there anything to note on the competitive side- Are you seeing anything competitively from some of the other devices out there, of note? And then I'll have a follow-up.

So yes, first on your backlog question. In the 4th quarter, we started-you may note it included in our assessment of the COVID impact, Anthony, just to be clear, when we assess the COVID impact, the next COVID, it grew by 335% included in that our procedures above the base rate calculation on the year before 2019. So, quarter 4 cancellations above that base rate if you were to put a value on it is around $4 million bucks. So, that might give you an indication of that backlog that those cancelled procedures should come back at some stage when things free up and those are procedures that were booked- the patient was due to have the UroLift procedure done and then either the day before or on the day they cancelled the procedure, one would have to assume because of concern over COVID. So, that's the best benchmark. I can give you in that regard. What was the other part of your question? Anthony, I apologize.

The other part was on competition, anything of note that you've seen out?

Nothing to report really. Same competitors are in the marketplace. I mean we have now crossed the 250,000 patient mark that have been treated with the UroLift which is a big milestone for us. The other big milestone for us it was an all-time high revenue in the 4th quarter. We've never hit that revenue and you hit that in the midst of a rising COVID pandemic where situation, got a lot worse to me is very encouraging. So, nothing to report new on the competitive front, Anthony.

And then the follow-ups, would be one on UroLift again would be- can you remind us on medical management, the study referenced today, how many patients do you actually think could shift to UroLift in the medical -- that are currently medical management today and then on Z-Medica there's 3 verticals; trauma, EMS and Interventional where do you think you will see the most synergies at the revenue line, with the existing Teleflex infrastructure? Thanks.

So, first on your UroLift. The number of men on medical therapy are the total 12 million men in America, 1.5 million of them have stopped taking the medical therapy and that's our target market of 6 billion, but there are another 7 million men in America that are taking the drug therapy. So, it's a significantly bigger market and that takes the addressable TAM from $6 billion to $30 billion if we were able to attract all of those individuals as well. So, that will give you the size of the scale. With regard to your question on the synergies are where we will be able to leverage Z-Medica from a call point. For definite, the military and EMS call point is a really strong call point for us and Z-Medical have an exceptionally strong trauma call point. So, the synergies between the 2 companies is excellent in the strength that they now call point. And then just consider that Anthony that we have EZPlas, that we just submitted from a BLA coming down the PICC behind that really strong sales channel. So, that's a business with enthusiasm and we're quite encouraged with what we can do in that space.

Thanks again.

Your next question comes from Matthew O'Brien with Piper Sandler.

Good morning and thanks for taking the questions. I guess, Liam-I think that's going to get most people's attention this morning is the revenue guide for '21 if you're taken out Z-Medica. It's kind of a 6.5% to 8% growth on a constant currency basis and you easy comps and I understand there is still some COVID impact. Can you break down a little bit what you're expecting from maybe a volume perspective, this year and where that kind of below trend line as far as what people are expecting out of out of Teleflex from organic growth rate or are there other areas where you're trying to be-I know you're trying to be conservative, but more conservative than others-it seems like UroLift might be one of those areas, just any kind of color you can provide on kind of organic guidance that you provided for the full-year would be helpful.

Matt, thank you very much for the question and it really comes down to when do you assume that you're going to see recovery from COVID. Now, we could have been more aggressive in our guidance and assumed that we will begin to see recovery from COVID in Q2. I don't think it's anything to do with volume versus price, versus all the other components, Matt, quite frankly, it's all down to COVID and it's all down to the assumption that you make on COVID. So, if we were to be more aggressive and we would assume going to assume we're going to see a recovery in Q2 as I've heard from some of our peers that they have I think, it would be a more robust revenue story and therefore more robust earning story. As I said to the question, I think David asked-we've tried to be a little bit more prudent and perhaps a little bit more conservative. We still see it's going to be quite choppy as you go through Q1 and Q2. And don't forget the COVID cases in January and early February were much worse than they were in December and late November. And so that's the gating factor, Matt, is your assumption on when COVID is going to recover. And if you look at it and sometimes people want to go back to 2019 and if you look at the back half of 2019, compared to 2021 we're back in that normal, long-term guidance range for Teleflex in the back half '21 versus '19 and again it's all about the assumption-if you assume you're going to recover in Q2 and be aggressive, your revenues is greater. If you assume the back half of the year, your revenue is going to be a little bit less, but you have some conservatism built in and obviously we'll update the investment community when we get to our Q2 earnings release as to what we've seen in that quarter and if it's better, good for investors, great for Teleflex and so on so forth.

Got it and then as the follow-up, I'm going to go a little off topic, I know there's a lot of NeoTract and Manta, any class questions but you're spending quite a bit of money on MDR it looks like about $10 million bucks this year. And I know your U.S. story right now, but I'm just curious with that spend, if you know OUS growth just because others can't spend as much and be prepared as you are could be an area of potential upside as we get into '22, '23 and '24 just strategically with all the investments we're making on the MDR side. Is that an area that could surprise some folks as far as the upside goes in a couple of years?

So, I think what you might see happening, Matt, is that the requirements for MDR are significantly burden on someone companies and what you might see, is it be particularly burden on small companies. Now there are a lot of smaller med-tech companies in Europe that I think are going to struggle to continue to comply with MDR and they have to meet the same standards, naturally enough as a larger company like Teleflex. So, 2 things either going to happen. I think those individuals will either decide they don't want to be in particular space is anymore, which will create opportunities for the larger companies or you will see consolidations and M&A opportunities to buy up some of these smaller organizations within Europe. And as you know Teleflex is a serial acquirer, and we will look to take those opportunities as they arise.

Thank you.

Your next question comes from Matthew Mishan with KeyBanc.

Great. And thank you, for taking the questions.

Hey, Mark.

Hey, Liam, I'm just too really on EZPlas. Could you some context on the complexity of the BLA for EZPlas and why it took several years to get through it and what have you kind of worked through with the FDA that would give you confidence for approval in a reasonable timeframe. And then as a follow-up to that on ask-For Z-Medica and EZPlas, would they share the same sales force and how are you thinking about kind of ramping that sales effort.

Yes, absolutely. So, first of all I'll answer the last part of the first. They will share in the same sales force, Matt. And we are combining the Z-Medica and the Teleflex sales force together and that gives us an opportunity to have an even stronger sales force in this channel in order to help us accelerate both Z-Medica and Vidacare and EZPlas when it becomes available. The time that it took for the BLA submission, Matt, was really driven by the fact that this was unchartered waters for both the FDA and for Teleflex. The FDA had never previously approved a biologic of this nature. So, it was unchartered territory for them and for us. And therefore, it took a significant amount of time for them to get through their assessment as we fed them information because to their credit, they work with us, they allowed us to submit partial information as part of the BLA submission. So, that's what allowed us to give them some information, get some feedback, give them more information, get some feedback, and finally, we got the submission done in January. Now why I would think that it should take less than the nine months is number one, we're on a fast track and number two is that had all the clinical data and given us the feedback on the clinical data. We've already given them a significant bolus of data before we submitted the final BLA submission. So, they've had a significant amount of data from us. So, therefore that should help in their assessment and they have also been very cooperative in working with us and the military in moving this through the BLA submission. So, all of those factors would lead me to be quite encouraged by a reasonable timeframe, less than the nine months to get this approved. Excellent. Thank you. Your next question comes from Mike Matson with Needham & Company.

Good morning, thanks for taking my questions.

Hi, Mike.

I have a question on EZPlas. So, I know there's a lot of folks on the BLA and the U.S. opportunity, but is there any international opportunity for this product.

There is. Mike. Now in the military to 25 million is the majority of that is in the U.S. but there is a portion overseas and of course the civilian market is a global number. So, out of 100 million needs a global number, not just a U.S. number and again it's the same criteria overseas. It's the air ambulances and the military. But as most people would be aware, the U.S. military is one of the more active and larger military organizations on the planet, and therefore it commands a significant portion of that $25 million addressable market.

Okay, got it. And then wanted to ask about your PICC business. They used to get a lot of attention but given some of the newer growth drivers hasn't been getting as much, so are you still taking share in that market? Has there been any sort of changes in the competitive dynamics there?

So, I'm very pleased to report, and I think I mentioned in my opening remarks, but the our PICC business in the quarter grew almost 20%. Mike. So, we continue to take share and we continue to be really thoughtful as we grow that business because of our coating technology that allows us to take share from the competitors there. And in a very short period of time of three years, we've moved from being the number three player to being the number two player and we continue to grow aggressively in that space.

Okay, thanks.

I'm showing no further questions at this time. I would now like to turn the conference back to Jake Elguicze.

Thank you, operator. And thank you everyone that joined us on the call today. This concludes the Teleflex Incorporated fourth quarter of 2020 Earnings Conference Call. Have a nice day.

Ladies and gentlemen this does conclude today’s conference call. Thank you for participating. You may now disconnect.