Teleflex Q3 2021 Earnings Call Transcript

Quartr
Provided by Quartr
October 27, 2021

There are 9 speakers on the call.

Operator

Good morning, ladies and gentlemen, and welcome to the Teleflex Third Quarter of 2021 Earnings Conference Call. At this time, all participants have been placed in a listen only mode. At the end of the company's prepared remarks, We will conduct a question and answer session. Please note that this conference call is being recorded and will be available on the company's website for replay shortly. And now I will turn the call over to Mr.

Operator

Laurence Kirsch, Vice President of Investor Relations and Strategy Development.

Speaker 1

Good morning, everyone, and welcome to the Teleflex Incorporated Third Quarter 2021 Earnings Conference Call. The press release and slides to accompany this call are available on our website at teleflex.com. As a reminder, this call will be available Or for international calls, 416-621-4642 using the passcode 407 9,822. 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 the call to Q and A.

Speaker 1

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 ks, which can be accessed on our website. During this conference call, you will hear management make statements regarding intra quarter Business performance, management is providing 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'll now turn the call over to Liam for his remarks.

Speaker 2

Thank you, Larry, and good morning, everyone. It's a pleasure to speak with you today. For the Q3, Teleflex generated double digit constant currency revenue And 27% adjusted earnings per share growth on a year over year basis despite a greater than expected headwind From increased COVID-nineteen infections due to the Delta variant, all of our global product families grew On a constant currency basis year over year, with the exception of our other category due to the divestiture of the respiratory assets To Medline, although we encountered a change in macro trends versus expectations at the time of the second quarter, The solid performance for Teleflex during the Q3 of 2021 reflects the diversified nature of our business and the benefits of the company's broad portfolio of medically necessary products and category leadership. Our 6 Primary product families and broad global footprint helped offset pressure on product revenues associated with elective surgery that were subject to pauses during the Q3. As many investors will be aware, there were restrictions on elective surgical procedures In as many as 28 states during the Q3.

Speaker 2

However, as we have seen since the pandemic began, Our broad based portfolio provides a hedge in periods of increased COVID activity with more than 60% of our business either benefiting from increased COVID related treatments or remaining relatively insulated from disruptions due to the pandemic. Although we do not routinely provide intra quarter commentary, given the larger than expected surge in COVID-nineteen infections From the Delta variant, I will share some details for the Q3. Relative to guidance provided at the time of our Q2 earnings report, We saw a greater than anticipated pause in elective surgical procedures across select geographies in the U. S, Europe and Asia. However, as COVID-nineteen infections trended down, we saw our average daily sales for products most exposed to elective surgical procedures begin to improve as we progress through September.

Speaker 2

During the Q3, Our diversified product portfolio, for the Q3, gross and operating margins exceeded levels achieved in 2020 and 2019 in comparable periods. Our continued progress in margin expansion in 2021 has allowed us to increase Directed investments towards growth drivers, which is an important component of our long term strategy to enhance Durable growth. As we look to close out the year, we anticipate some modest improvement through the Q4 as compared to the 3rd quarter, but acknowledge that the macro environment is not yet where we had expected it would be at the start of the year. We remain cognizant of uncertainty around COVID-nineteen infections as the weather turns colder in the Northern Hemisphere, new variants and healthcare worker shortages. Accordingly, we believe that it is prudent to assume that COVID-nineteen will remain a headwind And that a broad based return to elective surgical procedures to normal volumes is unlikely during the Q4.

Speaker 2

We anticipate these elements to be transitory in nature, and we expect a more normalized environment to be established in 2022. Given our year to date results and outlook for the Q4, we are reducing our constant currency revenue growth to a range of 8% to 9% from 8.5% to 9.75% previously. The revision in the constant currency growth outlook is primarily driven by lower growth expectations for products used in elective surgical procedures. However, given strength in our operating margin performance And improvements in our balance sheet, we are increasing earnings per share guidance to a range of $13.15 to $13.35 versus our previous range of $12.90 to $13.10 implying growth of 23% to 25% year over year. Turning to a more detailed review of our 3rd quarter results.

Speaker 2

3rd quarter revenue was $700,300,000 an increase of 10.3% year over year on a constant currency basis. The year over year increase reflects the benefit of our diversified portfolio and was driven by contributions from all business segments offset by the impact The COVID-nineteen and the divestiture of the respiratory assets to Medline. In comparison to the comparable period in 2019, 3rd quarter revenue increased 5.8% and demonstrated accelerating quarter over quarter growth in our vascular, OEM and anesthesia businesses, which offset sequential deceleration in areas of the business more exposed to the surge in COVID-nineteen, including Interventional Urology, Interventional and Surgical. 3rd quarter gross and operating margin performance Exceeded our expectations, reflecting the strength of our diversified portfolio, partially offset By greater than anticipated headwinds from COVID-nineteen, our year to date margin performance is an encouraging sign for our longer term profitability Objectives. 3rd quarter adjusted earnings per share of 3 point 5 year over year and exceeded our internal expectations.

Speaker 2

Despite higher than anticipated headwinds from COVID-nineteen On our adjusted earnings per share results in the Q3, the year over year performance reflects growth In our diversified product portfolio, modest price increases, gross margin expansion and better than expected Operating expense management. We continue to execute on our strategy to deliver durable growth with investment in organic growth opportunities, Product innovation, margin expansion and deployment of capital for deleveraging our balance sheet and M and A. I am proud of how the team continues to execute in a challenging environment. Our Q3 financial performance demonstrates the resilience Our diversified global product portfolio, our targeted investment in growth drivers, including UroLift and MANTA, while also reflecting progress Towards our longer term margin aspirations, turning now to a deeper look at revenue results. I will begin with a review of our reportable segment revenues.

Speaker 2

All growth rates that I refer to are on a constant currency basis unless otherwise noted. America's revenues were $417,300,000 in the 3rd quarter, which represents 10.9% growth Year over year, contributors to the year over year growth were surgical, vascular and interventional, Partially offset by the impact of pauses in elective surgical procedures, EMEA revenues of $143,900,000 Increased 3.6% year over year with interventional and vascular products leading the growth. EMEA benefited from a favorable COVID-nineteen related comparison due to improved procedure volumes year over year as countries across the region continued to open up despite disruptions related to COVID-nineteen. Turning to Asia. Revenues were $75,000,000 increasing 6.3% year over year.

Speaker 2

Japan was strong in the 3rd quarter, Growing north of 30%, but was partially offset by the impact of COVID-nineteen in Southeast Asia. Let's now move to a discussion of our 3rd quarter revenues by global product category. Consistent with my prior comments Regarding our reportable segments, commentary on global product category growth will also be on a constant currency basis and ranked By size of our business units. As a reminder, there were no meaningful differences in year over year selling days in the 3rd quarter. Starting with vascular access.

Speaker 2

3rd quarter revenue increased 8.5 percent to $175,500,000 Our category leadership in central venous catheters and midlines, along with our novel coated PIC portfolio continues to position us For dependable growth, our vascular access portfolio remains important in the treatment of COVID-nineteen patients, Driving strength in the Q3 due to increased rates of coronavirus infections. Our PIK portfolio Continued to perform well with 10% growth year over year. We continue to invest behind our differentiated PIC portfolio and are taking market share. Intra Osseus was also solid in the 3rd quarter with growth up 12% year over year. Moving to Interventional.

Speaker 2

3rd quarter revenue was $104,300,000 up 10.4% year over year. We executed well during the Q3, although increased COVID-nineteen infections slowed complex PCI and TAVR procedures. We continue to invest behind our interventional portfolio, including Complex catheters and MANTA, our large foreclosure device. MANTA momentum remains strong both in the U. S.

Speaker 2

And in international markets with over 80% global growth year over year in the Q3. Given the year to date performance for MANTA, We are confident in our ability to achieve 8% share in 2021 of the 200,000,000 to 300,000,000 Global market opportunity. Turning now to anesthesia. 3rd quarter revenue was $97,100,000 up 26.6 percent year over year. Products from ZMedica contributed roughly 85% of the growth as the business continues Back to our $60,000,000 to $70,000,000 revenue expectations for 2021, partly offset by lower sales of Tracheostomy products.

Speaker 2

In our surgical business, revenue was $92,800,000 representing 10.9% growth year over year. Among our largest product categories, we witnessed robust growth in sales of our ligation clips and instruments as the elective Surgical procedure environment was stronger than in the prior year period, partially offset by the impact of the delta variant in select geographies. For Interventional Urology, 3rd quarter revenue was $83,100,000 an increase of 1.5% year over year and below our expectations at the time of the quarter surgery cancellations due to state restrictions and ICU capacity limitations as delta variant infections rose sharply in certain regions of the U. S. As well as continued business disruption associated with the pandemic.

Speaker 2

We are closely monitoring trends in our UroLift business. Importantly, our analysis of commercial and Medicare billing claims over the past 6 months Indicates that UroLift has not lost market share to competing minimally invasive treatments for BPH and remains the leading procedure. We continue to see COVID-nineteen as having the most significant impact on UroLift utilization with physician office staffing shortages also disrupting the business. We see both of these impacts as transitory in nature I expect a more normalized environment in 2022. The preference for UroLift continues to be driven by strong clinical results with studies showing rapid symptom relief and recovery, no new sustained sexual dysfunction and durable results.

Speaker 2

Indeed, our analysis shows that very few of our experienced users offer other technologies for the treatment of BPH Given their confidence in UroLift, the UroLift system remains distinct from other device based BPH treatments, And we intend to maintain our leading market position in day surgery treatments for this condition. We continue to target patients Estimated to be 1,500,000 men in the United States. As we look towards the Q4 of 2021, we are assuming When taking into account the softer than expected UroLift revenues during the Q3 and our recalibration of the 4th quarter, We are reducing our 2021 Interventional Urology revenue growth guidance to 15% to 17 We would anticipate a more normal environment for elective surgical procedures to emerge during 2022. We remain encouraged by the physician engagement as measured by our active users, new physician training and the ability to perform UroLift procedures in all relevant care settings. Our OEM business, which accounts for roughly 9% of total sales, Increased 29.4 percent year over year to $64,100,000 in the 3rd quarter.

Speaker 2

We continue to see strength in our OEM business As customer ordering normalizes and we remain well positioned in our markets with customers valuing our design and manufacturing capabilities. And finally, our other category, which consists of respiratory products that were not included in the divestiture to Medline, Manufacturing service agreement revenues and urology care products declined by 4.3% to $83,400,000 year over year. The decline largely reflects the loss of revenue due to the divestiture of the respiratory products, partially offset by manufacturing service agreement revenues and growth in urology care. We continue to expect manufacturing service agreement revenues to phase out at the end of 2023. That completes my comments on the Q3 revenue performance.

Speaker 2

Turning to some commercial updates and starting with UroLift. In the Q3, we trained 124 urologists. Interest in UroLift remains strong. And with over 3 55 doctors trained in the year to date, we remain positioned to meet our training target of 450 to 500 urologists in 2021. Turning to our consumer marketing efforts.

Speaker 2

We continue to view direct to consumer As a multiyear catalyst for UroLift in the United States, we have continued to fund our DTC campaign to prime the pump for the recovery in elective procedures, And we'll keep investing in the Q4. We recently won a bronze award for Best New Branded Television Campaign From DTC perspectives, which is a meaningful accomplishment given 13 finalists, search interest for UroLift remains I am well above other minimally invasive BPH treatments with the majority of urologists surveyed continuing to report Patients asking for the UroLift system. Moving to UroLift 2, we remain on a full rollout in the United States. We formally launched the product as well as the UroLift ATC to the broad urology community at the AUA meeting in September. We are well positioned to convert The majority have positioned customers to UroLift 2 by the end of 2022 fueled by advantages in tissue compression, Reduced storage space and increased manufacturing capacity.

Speaker 2

UroLift 2 remains an important margin driver as we remain positioned to generate 400 basis points of EuroLift gross margin expansion as the revenue base is fully converted. Regarding Japan, we continue to make progress towards an upcoming commercial launch for UroLift. Recently, the 3 major Japanese urology societies agreed on guidelines for UroLift usage, which is a positive development. As for reimbursement approval, we remain highly engaged with the MHLW and have been Officially notified that UroLift will be reviewed at an expert panel in November. Although we cannot control the timing Of the regulatory pathway, the panel confirmation is an important milestone towards reimbursement in Japan, marking one of the final steps in the process.

Speaker 2

There is no change to our baseline assumptions that our commercial ramp will begin in 2022. Japan remains an important long term opportunity for UroLift With a $2,000,000,000 TAM and we are excited for our upcoming launch, we continue to expect our sales in the region to ramp In a similar fashion to the U. S. In a market that is 1 third the size. Aside from Japan, Our international regulatory and commercialization efforts for UroLift remain active.

Speaker 2

On another positive note, we are excited About our initial commercial activity in Brazil, although we had been expecting to enter Brazil in late 2022, We have been able to shorten our timeline with a limited market release late in the Q3 of 2021. We have made good progress With select key opinion leader training and initial UroLift cases have already been performed in the hospital and office setting. Although it is early and the market will take some time to develop, Brazil remains an important geography in our expansion of UroLift outside of the United And we are quite encouraged by the early experience. On the U. S.

Speaker 2

Reimbursement front and as a reminder, CMS published its proposed physician fee schedule for calendar 2022 on July 13, 2021. The proposed rule would negatively impact reimbursement for roughly 600 procedures performed in the doctor's office across A broad range of surgical specialties with a disproportionate hit to device heavy procedures such as UroLift. Teleflex provided a detailed response to CMS during the public comment period regarding our position on the proposed rule. We believe that the changes to the physician fee schedule would limit health care access for Medicare patients and shift The current proposed rule. We anticipate that the final rule will be published in November, consistent with historic timing.

Speaker 2

Turning to vascular. We are pleased with the performance of our recently launched ARO ErgoPac kit, which contributed over $5,000,000 in revenue during the Q3. Among other improvements, the new kit configuration for our Given our leading market share in CVCs, the launch is a trade up strategy that drives incremental gross profit dollars and help sustain our dominant market leadership position in CVC. Lastly, on our acquisition of ZMedica, which was completed in December of 2020. The integration of ZMedica continues to track slightly ahead of our internal milestones, and we are pleased with the progress we are making.

Speaker 2

Regarding potential label expansion opportunities For the hemostat portfolio, we have completed patient enrollment in a 231 patient IDE study Evaluating the performance of QuickClot Control Plus Hemostatic Devices for mild to moderate bleeding In cardiac procedures as compared to standard goals, we intend to file a 510 For expanded use of QuickClap Control Plus following the completion of the study. That completes my prepared remarks. Now I would like to turn the call over to Tom for a more detailed review of our Q3 financial results. Tom? Thanks, Liam, and

Speaker 3

good morning, everyone. Given the previous discussion of the company's revenue performance, I'll begin at the gross profit line. For the Q3, Adjusted gross margin totaled 59.5%, a 230 basis point increase versus the prior year period. The year over year increase in gross margin was driven by product and regional mix, benefits from cost improvement initiatives, Favorable impacts from pricing, M and A and foreign exchange, partly offset by raw material and distribution inflation. 3rd quarter adjusted operating margin was 28.5 percent or a 3 40 basis point year over year increase, driven by the gross margin improvement as well as disciplined expense management and partially offset by planned investment in the business.

Speaker 3

For the quarter, net interest expense totaled $11,800,000 a decrease from $16,400,000 in the prior year period. The year over year decrease in net interest expense reflects savings from the redemption of the 2026 notes and also includes the impact debt pay down using the proceeds of the respiratory divestiture and operating cash flows. Our adjusted tax rate for the Q3 Of 2021 was 11.3% compared to 7% in the prior year period. The year over year increase in our adjusted tax rate Bottom line, 3rd quarter adjusted earnings per share increased 26.7 percent to $3.51 Included in this result is an estimated favorable impact from foreign exchange of approximately $0.13 per share versus prior year. Turning to slide balance sheet and cash flow highlights.

Speaker 3

Year to date, cash flow from operations totaled $450,500,000 compared to $241,500,000 in the prior year period and represented a year over year increase of $209,000,000 The increase was primarily attributable to favorable operating results, lower contingent consideration payments, lower payroll and benefit related and proceeds received under the manufacturing supply agreement with Medline. Moving to the balance sheet. Our financial position remains sound. At the end of the Q3 2021, our cash balance was 481,200,000 versus $375,900,000 at the end of the Q4 of 2020. As noted previously, We made a $259,000,000 payment in July against our revolving credit facility using funds primarily generated From the initial close of the respiratory business divestiture, at the end of the Q3, we had $342,000,000 drawn on our revolver And net leverage was approximately 2x.

Speaker 3

Now moving on to our 2021 guidance update. Starting with revenue, we are adjusting Our 2021 constant currency revenue growth guidance to a range of 8% to 9% year over year Compared to 8.5% to 9.75% previously, the revised outlook reflects the benefits of our diversified portfolio offset by lower UroLift revenues due to the recovery in elective surgical procedures progressing at a slower rate than what our prior 2021 financial guidance Turning to currency. We continue to assume a 2% tailwind to reported revenue from foreign exchange rates in 21, which is unchanged from our previous assumption. As a result, we are reducing our as reported revenue growth guidance to 10% to 11% year over year versus 10.5% to 11.75% The updated guidance would equate to a dollar range of between $2,791,000,000 $2,816,000,000 Now for Some commentary on our margin outlook. We are lowering the top end of our 2021 adjusted gross margin guidance by 25 basis points to a range of between 59.25 percent 59.5 percent.

Speaker 3

On a year over year basis, we expect gross margin expansion to as well as from manufacturing productivity improvement programs and benefits from previously announced footprint restructuring programs, partially offset By inflation, relative to our prior guidance, the revised outlook is associated with lower year lift revenues and the impact of higher inflation than previously assumed. There's no change to our expectation that ZMedica will add approximately 50 basis points to gross margin for 2021. On the topic of inflation, we continue to experience increased cost pressures in raw materials, freight and to a lesser extent labor. Additionally, at the end of 2020, we had entered into contracts for sea freight lanes in order to lock in pricing at that The majority of those contracts expired at the end of September with the remainder expiring at the end of the year. As a result of Expiring shipping contracts and increasing inflation, we now estimate that inflationary costs will be roughly $3,000,000 higher in the 4th quarter than what was incurred in the Q3.

Speaker 3

This impact is reflected in our revised guidance for gross margins. For Adjusted operating margin, we are increasing our 2020, 2021 guidance range to 27.5% to 28%, representing an increase of 75 basis points at the low end and 50 basis points at the high end of the range versus prior guidance. The increase in adjusted operating margin reflects the year to date performance, partially offset by the lower gross margin outlook. Moving down the P and L. We now expect interest expense to be roughly $57,000,000 versus our previous guidance $60,000,000 to $62,000,000 The decrease in net interest expense for 2021 largely reflects a reduction in debt funded by proceeds from the respiratory divestiture and our strong cash flow generation.

Speaker 3

On taxes, we now expect Our adjusted tax rate for 2021 to be roughly 12% to 13% versus the prior range of 13% to 13.5%. Considering all of these elements, We are raising our adjusted EPS outlook for 2021 by $0.25 at the high and low end of the range to $13.15 to $13.35 a 23.2 percent to 25.1 percent year over year increase. And that concludes my prepared remarks. I would now like to turn it back to Liam for closing commentary. Liam?

Speaker 2

Thanks, John. In closing, I will highlight our 3 key takeaways from the quarter. First, our diversified product portfolio enables Teleflex to deliver double digit constant currency growth in the Q3, even with greater than expected disruption from COVID-nineteen. 2nd, We continue to execute on our strategy to drive durable growth across our diversified portfolio with investment in organic growth opportunities, margin expansion and deployment of capital for M and A. 3rd, we raised our earnings per share guidance for 2021, reflecting 23% to 25% By our diversified portfolio of medically necessary products, our balance sheet is in a solid position With leverage at 2x, providing ample financial flexibility for our capital allocation priorities, We remain confident in our future and our ability to continue to meet commitments to patients, clinicians, communities and shareholders.

Speaker 2

That concludes my prepared remarks. Now I would like to turn the call back to the operator for Q and A.

Operator

Thank And now our first question comes from Matt Taylor from UBS. Your line is open.

Speaker 4

Hey, good morning. Thanks for taking the question.

Speaker 2

The first thing I wanted to ask

Speaker 4

you about was What you're assuming for Q4 and recent trends? From the commentary that you made about the environment, it seems like You're assuming stability with some of the subdued trends that you saw in late Q3. And so I just want to make sure that was correct and Get any color on what you've actually seen happen in the early part of Q4?

Speaker 2

Matt, thank you very much for the question. I think that as we look into the Q4, we have to start with what we saw in the Q3. And we're really pleased With our revenue results, which were better than our expectations and clearly demonstrate the advantage of a global diversified portfolio. In the quarter, even though certain elective aspects of our business such as UroLift Interventional Access and Surgical were impacted by COVID, We still met expectations for revenue in that top environment and exceeded our expectations on margins and EPS. I mean EPS We grew 27% within the quarter.

Speaker 2

In Q3, we delivered growth of 10.3% over 2020 and nearly 6% over 2019 and we saw strength in OEM, the Americas, EMEA and APAC. And in fact, Matt, EMEA and APAC would have grown 6.8% and 12.2%, respectively, when you normalize for the impact of the respiratory divestiture. We also saw strength within many of our segments, surgical, interventional, vascular and anesthesia. And our key growth drivers ex UroLift Continued to deliver really solid results. MANTA grew 82%, Intraropsis grew 12%, PIX grew 10%.

Speaker 2

And To your question, as we progress through the quarters, procedure volume did not recover in line with our original expectation, And we are not as far along on the recovery slope as we had hoped. UroLift is clearly a deferrable procedure, and I would look at it as revenue deferred Rather than revenue postponed, procedures began to be impacted in the second half of July, but we did see improvements, Matt, in September Within all of our procedure volumes that were impacted and if you look at our Assumptions for UroLift in particular and our updated assumptions for UroLift, the lower end of the range would be Pravit able to a flat lining of what we saw in September through the end of the year in that regard. I don't really want to get into The sense of Q4, Matt, because there's only 1 quarter left. And clearly, our guidance outlines what we're expecting in Q4 from all aspects of our business.

Speaker 4

Okay. All right. Thanks. Thanks, Neil. Thanks for all that color.

Speaker 4

Maybe I could just ask you one question about The UroLift reimbursement, obviously, we'll see what happens here over the next week or so with the final outcome of the office space reimbursement. How are you preparing for some of the different scenarios, if the cut stays or if there's a phase in or hopefully there's something better? But Maybe you could talk about what you think the company would need to do under some of those different things that could happen to help Physicians maintain their business in the office or move it to the ASC if they have to?

Speaker 2

Yes. So you're correct, Matt. There's no update. As we sit here Today, we would expect the proposed ruling to come through in early next month. That's the normal time line for it.

Speaker 2

We've really put a strong case to support the CMS rethink of the proposed ruling. We believe it will limit Medicare and Medicaid patient access to over 600 procedures, and we still believe the appropriate Action is to cancel the proposed ruling and engage with key stakeholders on a new proposal. As I'm not sure the investment community is aware, but there were over 30,000 comments during the comment period, and we believe that CMS is duly bound to take all comments into consideration. When the final ruling comes out, it is Rx we anticipate issuing a press release, Matt, on the publication. We have certain advantages Over other minimally invasive procedures in so far as we have flexibility with size of service.

Speaker 2

The UroLift Procedure is profitable not only in the office, but also in the ASC and the hospital. And the vast Majority of urologists that do their procedure in an office have part ownership or to an ASC and have that level of flexibility. So we'll wait for the final ruling, Matt, and then we'll make a decision on how we will Proceed. But rest assured, plans are afoot within Teleflex to move quickly once we get the final ruling.

Operator

Our next question comes from Cecilia Furlong from Morgan Stanley. Your line is open.

Speaker 5

Great. Good morning and thank you for taking the questions. William, I wanted to continue with UroLift and ask if you could talk about just procedure deferrals, Either the impact that DTC may have had during the quarter or just COVID pressure, but as you think about 4Q, What you contemplated from potentially being able to recapture those procedures? And also how you're looking at the environment today from a Deferral recapture perspective versus what played out in the March April time frame.

Speaker 2

Yes. So I'll start with the last of it. I think that hospitals are much better able to adapt to the COVID environment. And I think They're managing the subsequent waves much better. Regarding the deferral of the procedures and the DTC, At DTC, we're really encouraged by the response we're getting from that.

Speaker 2

We do anticipate 150% the number of impressions and we're well on track through Three quarters to get to those number of impressions. The number of patients responding through the campaign continues to As I said earlier, is that the low end of the range implies the flatlining of September run rate for the remainder of the year. Now Cecilia, to your point on deferral procedures and other aspects, we do expect to see some seasonal improvement due to the deferral and also due to patients using up their deductibles during the year as we have seen in previous years. And we would also expect to enter into normal trading environment in 2022. And the market opportunity hasn't changed.

Speaker 2

I mean, I think that's the most important thing. There's still 12,000,000 men that suffer with PPH. UroLift is still the go to product for the treatment of PPH, And we've still only done 30 just over 300,000 procedures of those 12,000,000 men. And we still only trained 3,000 out of the 12,000 urologists. So we still have a significant and massive opportunity to continue to convert those that Customer base.

Speaker 2

And our own observation is that the procedure is just deferrable, more so We would have thought quite frankly when we bought the company and also no one would have anticipated COVID in that environment. And we do think that there are Three aspects that are impacting the product. Number 1, appointments not being scheduled because of state restrictions And fear of COVID, I think number 2, scheduled procedures that are subsequently canceled and number And the lesser impact is really staffing shortages that are out there in the marketplace.

Speaker 5

Okay, understood. And I did want to ask just On staffing shortages as well, kind of the impact that you've seen there, either throughout 3Q, but then More recently, if that is a growing issue? And then also how you've seen site of care shift this quarter versus what you saw Earlier in the year with some cases being pushed into the office, but I'm just curious if you've seen similar trends or if it stayed more in line with your traditional breakout? Thank you.

Speaker 2

Thank you. It's pretty in line with what we saw traditionally, Cecilia, regarding that. We do see Day case procedures in hospitals rebounding, and that's one of the trends that we've seen. Regarding your question on staffing shortages, we would anticipate That the staffing charges would improve as we go through Q4 and into 2022. And that's simply because it's not doctors that First of the issues, it's a lot of the ancillary workers that are within the office, the ASC and the hospital.

Speaker 2

And a lot of those People unfortunately were furloughed in the midst of COVID. They've been receiving government checks. The government checks began to dry up in September. So we would anticipate a bolus of those individuals coming back into the workforce in Q4 and into 2022, and we would Anticipate seeing that environment improve also.

Operator

Our next question comes from Anthony Petrone from Jefferies. Your line is open.

Speaker 6

Great. Thanks and good morning everyone. Maybe Liam, just a high level on the nursing shortages, we're hearing it on several calls. It seems To be more pronounced in certain areas of the ICU, critical care, but there are other specialty areas that are seeing shortages as well. So Just from a high level, how substantial of an overall impact do you think nursing and hospital staffing shortages was in 3Q?

Speaker 6

And if you use your crystal ball looking into 2022, how long of a headwind do you think this is? Is it Transient or does it bleed deep into next year? And I'll have a follow-up on UroLift.

Speaker 2

Yes, Anthony, I think there's Inside of service, quite frankly, in the hospital environment, my observation is that the staffing shortage It's fatigue. A lot of these people are just exhausted from fighting COVID. And we've seen a lot of retirements as well in the nursing environment. I think that's going to take a little bit longer to work through, quite frankly, and get people back into that work environment. I think we may have to consider The importation or the acceleration of nursing through the education process or the importation of nursing through the issuance of visas To other jurisdictions.

Speaker 2

I think then if you look at the AAC and the office and in particular the office, the dynamic here, Anthony, is that These people were furloughed in the midst of COVID because office adopt working in an office is like a small business. So they have to try and protect Cash flow, the furloughed people, those people went down to government assistance. Now the government assistance dried up in or around September, that time frame. So I would anticipate that would probably rebound a little bit faster simply because those individuals will want to come back to the workforce in order to generate an income. So that's how I would see it.

Speaker 2

And if you recall, Anthony, we did call out staffing shortages in Q2. I think we're one of the fewer companies to start identifying it a little bit earlier on the trend.

Speaker 6

Appreciate that. And just the follow-up on UroLift. When you Sort of think about the potential that perhaps maybe the market froze here a bit ahead of the reimbursement announcement. Do you think any of that was at play in 3Q? Or was the bulk of the headwind here really just the deferral of procedures due to Delta?

Speaker 6

And so as you mentioned earlier, there's a high probability that these are recaptured over the next couple of quarters. Thanks again.

Speaker 2

I would say with a Very high degree of confidence, Anthony. It has nothing to do with CMS. The CMS ruling won't come in until next year and it hasn't even been announced. So it is all about COVID.

Operator

Our next question comes from Jayson Bedford from Raymond James. Your line is

Speaker 7

Hi, good morning. Just a couple of UroLift questions. Not to get too granular, but is Something different about the geographic makeup for your UroLift business that made it more exposed to Delta, meaning are you over indexed To Florida and Texas?

Speaker 2

Yes. So I think that we have very And presence in Florida and Texas, they're 2 of our key markets for EuroLift for sure. And you also have to look at, In particular, in Florida, the population, it's a big retirement community there. So the age profile of men in that area would obviously make it a significant market for us. I think the main impact of, Jason, of the in Eurydice in the quarter is simply the delta variant.

Speaker 2

It's simply 28 states have imposed restrictions. Now we would have thought that as we went through September, we would have anticipated Some of those states reducing the restrictions and we would have expected in this month October That they would have also been removing restrictions. And as I said earlier, it is a very deferrable procedure. I personally know 2 people that need the UroLift and neither of them are willing to have it done in this COVID environment. They're waiting until The environment improves.

Speaker 2

So I think that's the simple impact. And I think the word deferred is the important word because it is simply deferred. Those two people that I know personally are going to get the procedure done. It will happen. If it doesn't happen in Q4, it will happen in Q1.

Speaker 7

Okay. Okay. That's helpful. Just as a bit of a related follow-up, durable growth is obviously a focus for the team here. I I think the debate will turn to the level of durable growth that this business can produce.

Speaker 7

UroLift is obviously key to this debate. So It doesn't sound like your view of the end market has changed, but you did mention normalized growth a few times in reference to UroLift. So I'm just curious, What is normalized growth for UroLift?

Speaker 2

So I think as we would look at it, I would envision getting into And more normalized growth pattern once we get out the other side of coal, but this is simply a COVID impact on the business. I agree with you with your reference to durable growth. And let's reflect a minute. We grew 10.3% in the 3rd quarter, an outstanding result when you consider the environment that we're in. We drove 27% earnings per share growth in the Q3.

Speaker 2

And as you move into the Q4, I'm going to compare ourselves back to 2019 because that's a better base year for me. We grew 6% in Q3 over 2019. In Q4, the implied growth at the midpoint of our range is high single digits. So we're showing acceleration over 2019. So I believe that even in the midst of COVID, the advantage of a diversified portfolio is allowing us to Post real positive growth with real hefty earnings power as a result of that.

Speaker 2

Regarding your question on the durable what is durable growth for UroLift, Obviously, we're going to give guidance when we get through the Q4. I want to see how the Q4 plays out. I am keeping an eye on this new variance It has raised its head in the U. K. And in Israel.

Speaker 2

I would want to make sure that, that doesn't become an issue and become Delta Part 2 As we go through the Q4, but I agree with you. The end markets haven't changed. Our strength of our position in those end markets haven't changed. And the clinical outcomes of the product hasn't changed. It is the best product on the market.

Speaker 2

And once we get out the other side of COVID, we'll get back to normalcy.

Operator

Our next question comes from Matt O'Brien from Piper Sandler. Your line is open.

Speaker 4

Yes. Hi, guys. This is actually Drew on for Matt. And thank you for taking the questions. I do just want to ask about UroLift and DTC a little bit here.

Speaker 4

I mean, in your deck, you expect or you mentioned that you expect to double your impressions in 2020 year in 2021, but your revenues are obviously lagging that pace significantly. And obviously, I think it's obvious that COVID played a big part in that. But do you just have a sense for where those patients are currently going today? Are they getting into the doctor's office and being seen that their procedures are being deferred due to COVID? Or Are they facing logistical issues even getting to that point?

Speaker 2

Thank you. So we know for a fact that they're going to the doctor's office. We know because we actually direct To the doctor, so they're under the care of that doctor now. Again, the impact is simply COVID. You've got restrictions in In 28 states, you've got people that are not comfortable, quite frankly, going in to have a procedure and that is the impact.

Speaker 2

One data point that I think is important for investors to realize is the vast number of our champions are in the office and the ASC. And the vast, vast majority of those only offer 1 minimally invasive Modality for the treatment of BPH and that's UroLift. So by investing behind DTC And by transferring patients to those doctors with the best clinical output, those doctors in the vast majority Only offer UroLift. So that's why we have a heightened degree of confidence in continuing with our DTC. And I would just like to point out that our For impressions with the investment we're making is 150 percent and through 3 quarters of the year, we are well on track to achieve that level of impression.

Speaker 2

So we're very encouraged by the DTC. We're very encouraged by the engagement. And it was also nice Get the bronze award for the advertisement itself.

Speaker 4

Helpful. Thank you. And then just To kind of follow-up on that point a little bit, just on the competitive landscape, you have Boston talking about good progress with the Zoom, Olympus rolling out of your product in space. I know you said that share has been stable, but just wondering if your reps are bumping up against any of these other products in the space and Any sense for if your customers are taking a look at some of the newer products? Thank you.

Speaker 2

So I would read those comments closely because they combine 2 products in the comment. And as we analyze the data, we know that we're not losing share. It's not a question of if we know that we're not losing share. If you look at the claims data, it shows the market share is steady and UroLift is holding its dominant position with the minimally invasive treatment of BPH. So This is a COVID question, not a competitive question in my mind.

Operator

Our next question comes from Matthew Mishan from KeyBanc. Your line is open.

Speaker 8

Hey, great. Good morning, guys. I wanted to switch the conversation over to the margin side, gross and operating margins. I think, Tom, you laid out that you, I mean, almost a miracle lost in freight contracts like last December. Congratulations I'm doing that, but they're actually running, they're kind of really those are done at this point.

Speaker 8

How should we think about the headwind into the Q4 And really into 2022 of that excess freight logistics, as well as sort of Yes, lagging costs of materials that end up getting into your numbers as you kind of move forward.

Speaker 3

Well, I would say that

Speaker 7

as a result of locking

Speaker 3

in the contracts, we were able to save considerable expense during 2021. As mentioned, a number of those contracts did expire at the end of September and others at the end of December. So We do have some heightened inflation in the Q4. I cited $3,000,000 overall. The majority of that is really due to the increase In freight, both from the expiration of the sea freight contracts as well as just heightened inflation of overall logistics.

Speaker 3

And that will play into 2022 in terms of inflation. As we're looking at things right now, assuming Expenses stay at or rates stay where they are. We're going to see some heightened inflation throughout 2022 on the freight line. And obviously, we'll get into more detail on that as we provide guidance And we have greater clarity as to how the rates seem to be trending and whether we expect some recovery or not next year.

Speaker 8

And then on the Japan reimbursement for UroLift, were you with you now scheduled For it to be meeting in November, were you scheduled previously for it in September and then it didn't take it up or they took it up, but we'll move it to November. What's the logistics of why it was delayed by an extra couple of months?

Speaker 2

No, it's not delayed by a couple of months. It's they write out to companies and give them their time. They're going to review it. We got ours and it was November. In all transparency, we thought it was going to be October, but it was November, and we're really happy that they're going to review it then.

Speaker 2

It's a $2,000,000,000 market. It's a great opportunity for us. We've already done the pre market work in the marketplace, and we expect to ramp as we go through 2022. And we didn't anticipate any revenue in the Q4 in our original guidance. So We feel really encouraged.

Speaker 2

And also we feel encouraged by Brazil. We're early into Brazil much earlier than we thought. And we think that's going to be a nice market for us too. We've already Done, limited market launch. We've been down there.

Speaker 2

We've actually trained some surgeons. We've got proctors We feel really good about both Japan and UroLift. And we feel very good about the international expansion of UroLift on The global marketplace, which is as big an opportunity as the U. S. Market once we start to ramp overseas.

Speaker 8

All right. Thanks, Hans. Thanks,

Operator

comes from Michael Mattson from Needham and Company. Your line is open.

Speaker 7

Yes, thanks. Just want to follow-up The prior question on inflation, you're one of the few medtech companies that's really able to get positive pricing historically. Do you think you could maybe offset some of the inflation with additional price increases or shipping surcharges or anything like that If you needed to.

Speaker 2

Mike, thanks for the question. In a word, yes. We've seen positive pricing through the 1st 3 quarters of the year. We I agree with you, we're one of the few companies that is able to take positive pricing. We've taken some this year in order to offset some of the inflation We've seen and if you look at our margin progress to date, it's reflected in that.

Speaker 2

You can see how well we're doing from a margin in an inflationary As we get to next year, we'll get to next year. But it would be our thinking that we would offset some of the inflation with price increases. Shipping charges are harder to implement. People don't like them. You're better off, in my view, just looking at it as a straightforward price increase.

Speaker 7

Okay. Got it. And then just wanted to ask about EZPLAZ. I think the last time you Talked about you said you thought you could have an approval by the end of this year. Is that right?

Speaker 7

And is that still your thinking on it?

Speaker 2

So it's unfortunately, it's out of my control right now because it's with the FDA. We've got our submission in. We continue to engage with them. It's unchartered waters for the FDA. This is a they've never approved a biologic like this before, but they continue to engage with us.

Speaker 2

They continue to be helpful. And obviously, we'll update the investment community, Mike, as soon as we've news on it.

Operator

Thank you. There is no further question at this time. I would now like to turn the call over back to Larry.

Speaker 1

Thank you, operator, and thank you to everyone that joined us on the call today. This concludes the Teleflex Incorporated Third Quarter 2021 Earnings conference

Speaker 2

call.

Operator

This is currently all the time we have for questions this morning. This concludes our conference call. Thank you for your participation.

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Earnings Conference Call
Teleflex Q3 2021
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