Teleflex Inc

NYSE:TFX

Earnings Call Transcript 2021-Q3

[Operator]

Good morning, ladies and gentlemen, and welcome to the Teleflex, Third Quarter of 2021 Earnings Conference Call. [Operator Instructions]

And now I would like to turn the call over to Mr. Lawrence Keusch, Vice President of Investor Relations and Strategy Development.

[Lawrence Keusch]

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 www.teleflex.com.

As a reminder, this call will be available on our website and a replay will be available by dialing [phone] or for international calls [phone] using the passcode 4079822.

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 will open 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.

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.

[Liam Kelly, Chairman, President and Chief Executive Officer]

Thank you, Larry. And good morning, everyone. It’s a pleasure to speak with you today. For the third quarter 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-19 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-trend versus expectations at the time of the second quarter, the solid performance for Teleflex during the third quarter 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 six primary product families on broad global footprint have offset pressure on product revenues associated with elective surgery that were subject to pauses during the third quarter. As many investors would be aware, there were restrictions on elective surgical procedures in as many as 28 states during the third quarter. 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 insulators from disruptions due to the pandemic.

Although we do not routinely provide intra-quarter commentary, given the larger than expected surge in COVID-19 infections from the desert variant, I will share some details for the third quarter. 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-19 infections trended down, we saw our average daily sales for products, most exposed to elective surgical procedures begin to improve as we progressed through September.

During the third quarter, our Americas, EMEA, Asia and OEM segments demonstrated resilience with all the regions showing constant currency revenue growth over 2020, despite the headwinds from the Delta variant. As I mentioned earlier, this underscores the benefit of our diversified product portfolio. For the third quarter gross and operating margins exceeded levels achieved in 2020 and 2019 incomparable 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 fourth quarter as compared to the third 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-19 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-19 would remain a headwind and that our broad-based return to elective surgical procedures to normal volumes is unlikely during the fourth quarter. 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 fourth quarter, 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 arrange 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 third quarter results. Third quarter revenue was $700.3 million, an increase of 10.3% year-over-year on a constant currency basis. The year-over-year increase reflects the benefits of our diversified portfolio and was driven by contributions from all business segments obsessed by the impact of COVID-19 and the divestiture of the respiratory assets to Medline.

In comparison to the comparable period in 2019 third quarter revenue increased 5.8% and demonstrators 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-19, including Interventional Urology, Interventional and Surgical.

Third quarter growth and operating margin performance exceeded our expectations reflecting the strength of our diversified portfolio actually obsessed by greater than anticipated headwinds from COVID-19. Our year-to-date margin performance is an encouraging sign for our longer-term profitability objectives. Third quarter adjusted earnings per share of $3.51 increased 26.7% year-over-year and exceeded our internal expectations, despite higher than anticipated headwinds from COVID-19 on our adjusted earnings per share results in the third quarter, 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 as per de-leveraging our balance sheet and M&A. I am proud of how the team continues to execute in a challenging environment. Our third quarter financial performance demonstrate the resilience of our diversified global product portfolio are tired of that investment in growth drivers, including UroLift and MANTA, but also reflecting progress towards our longer-term margin aspirations.

Turning now to a deeper look at revenue results. I would begin with a review of our reportable segment revenues. All growth rates that I refer to are on a constant currency basis unless otherwise noted. Americas revenues were $417.3 million in the third 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 up $143.9 million increased 3.6% year-over-year with Interventional and Vascular products leading the growth. EMEA benefits from a favorable COVID-19-related as comparison due to improved procedure volumes year-over-year as countries across the region continued to open up despite disruptions related to COVID-19.

Turning to Asia. Revenues were $75 million increasing 6.3% year-over-year. Japan was strong in the third quarter growing north of 30%, but it was partially offset by the impact of COVID-19 in Southeast Asia.

Let’s now move to a discussion of our third quarter revenues by global product category. Consistent with my prior comments regarding our reportable segments commentary on global product category growth would 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 third quarter.

Starting with Vascular Access. Third quarter revenue increased 8.5% to $175.5 million, peak portfolio continues to position us for dependable growth. Our Vascular Access portfolio remains important in this – the treatment of COVID-19 patients, driving strength in the third quarter, due to increased rates of Coronavirus infections. Our peak portfolio continues to perform well with 10% growth year-over-year. We continue to invest behind our differentiated peak portfolio and are taking market share. Intraosseous was also solid in the third quarter with growth of 12% year-over-year.

Moving to Interventional, third quarter revenue was $104.3 million, up 10.4% year-over-year. We executed well during the third quarter, although increased COVID-19 infections still with complex PCI and TAVR procedures. We continue to invest behind our Interventional portfolio, including complex catheters and MANTA are large foreclosure device. MANTA momentum remains from both in the U.S. and in international markets with over 80% global growth year-over-year in the third quarter.

Given the year-to-date performance from MANTA, we are confident in our ability to achieve 8% share in 2021 of the $200 million to $300 million, up 26.6% year-over-year. Products from Z Medica contributed roughly 85% of the growth as the business continues to track to our $60 million to $70 million revenue expectations for 2021, partly offset by lower sales of tracheostomy products. In our Surgical business, revenue was $92.8 million, 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 for Interventional Urology people in $1 million, an increase of 1.5% year-over-year and below our expectations at the time of the quarter two conference calls.

The quarter was impacted by elective surgery cancellations due to state restrictions and ICU capacity limitations as Delta variant infections rule sharply in certain regions of the U.S. as well as continued business disruption associated with the pandemic. We are closely monitoring trends in our UroLift business. Importantly, our analysis of commercial and Medicare billing claims over the past six months indicate that UroLift has not lost market share to competing minimally invasive treatments for BPH and remains the leading procedure.

We continue to see COVID-19 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 and 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.

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 that are suffering from BPH and have either failed or are not satisfied with drug therapy, a population that is estimated to be 1.5 million men in the United States.

As we look towards the fourth quarter of 2021, we are assuming a relatively stable macro environment as compared to our September trends, given lingering COVID-19 headwinds for elective surgical procedures. When taking into account, the softer than expected UroLift revenues during the third quarter and our recalibration of the fourth quarter, we are reducing our 2021 Interventional Urology revenue growth guidance to 15% to 17% year-over-year.

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, accounts for roughly 9% of total sales increased 29.4% year-over-year to $64.1 million in the third quarter.

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 $83.4 million year-over-year 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 third quarter revenue performance. Turning to some commercial updates and starting with UroLift. In the third quarter, we trained 124 urologists. Interest in UroLift remained strong. And with over 355 doctors trained in the year-to-date, we remain positioned to meet our training targets of 450 to 500 urologists in 2021.

Turning to our consumer marketing efforts. We continue to view direct-to-consumer as a multi-year catalyst for UroLift in the United States. We have continued to fund our DTC campaign to prime the pump for the recovery and the elective procedures. I’m going to keep inventing in the fourth quarter. We recently won a bronze award for best new branded television campaign from DTC perspectives, which is a meaningful accomplishment given 13 finalist.

Search interest for UroLift remains high and 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 of physician customers to UroLift 2 by the end of 2022 fueled by advantages and tissue compression, reduced storage space and increased manufacturing capacity.

UroLift 2 remains an important margin driver. As we remained positioned to generate 400 basis points of UroLift 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 three 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. 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 billion 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 one-third the size. Aside from Japan, our international regulatory and commercialization efforts for UroLift remain active. 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 out after 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 States. And we are quite encouraged by the early experience.

On the U.S. 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 the disproportionate hit to device heavy procedures, such as UroLift.

Teleflex provided a detailed response to CMS during the public common period regarding our position on the proposed rule. We believe that the changes to the Physician Fee Schedule would limit healthcare access for Medicare patients and shift procedures to more costly sites of service.

Teleflex along with numerous other stakeholders have urge CMS to postpone the implementation of the proposed Physician Fee Schedule until additional analysis can be performed given the unintended consequences of the current proposed rule. We anticipate that the final rule will be published in November, consistent with historic timing.

Turning to vascular. We are pleased with the performance of our reasons they launched Arrow ErgoPack kit, which contributors over $5 million in revenue during the third quarter. Among other improvements, the new kit configuration for our CVC catheters as a Nitinol Guidewire, which kink resistant and an enhancement that clinicians find beneficial. Given our leading market share in CVC, the launch is a trade of strategy that drives incremental gross profit dollar and help sustained our dominant market leadership position in CVC.

Lastly, on our acquisition of Z-Medica, which was completed in December of 2020. The integration that Z-Medica continues to track slightly ahead of our internal milestones and we are pleased with the progress we are making. Regarding potential label expansion opportunities for the hemostatic portfolio we have completed patient enrollment in a 231 patient IDE study evaluating the performance of QuickClot Control+ hemostatic devices for mild’s-to-moderate bleeding in cardiac procedures as compared to standard goals. We intend to File a 510-K for expanded use of QuickClot Control+ following the completion of the study.

That completes my prepared remarks.

Now I’d like to turn the call over to Tom for a more detailed review of our third quarter financial results. Tom?

[Thomas Powell]

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 third quarter, 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&A and foreign exchange partly offset by raw material and distribution inflation. Third quarter adjusted operating margin was 28.5% or a 340 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.

For the quarter net interest expense totaled $11.8 million, a decrease from $16.4 million in the prior year period. The year-over-year decrease in net expense reflects savings from the redemption of the 2026 notes, and also includes the impact of debt pay down using the proceeds of the respiratory divestiture and operating cash flows. Our adjusted tax rate for the third quarter of 2021 was 11.3% compared to 7% in the prior year period. The year-over-year increase in our adjusted tax rate is primarily due to a lower benefit from stock based compensation compared to the prior year period. At the bottom line, third quarter earnings per share increased 26.7% to $3.51; included in this result it’s an estimated favorable impact from foreign exchange of approximately $0.13 per share versus prior year.

Turning to select balance sheet and cash flow highlights. Year-to-date, cash flow from operations total of $450.5 million compared to $241.5 million in the prior year period, and represented a year-over-year increase of $209 million. The increase was primarily attributable to favorable operating results, lower contingent consideration payments, lower payroll and benefit related payments and proceeds received under the manufacturing supply agreement with Medline.

Moving to the balance sheet, our financial position remained sound. At the end of the third quarter 2021 our cash balance was $481.2 million versus $375.9 million at the end of the fourth quarter of 2020. As noted previously, we made a $259 million 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 third quarter we had $342 million drawn on a revolver and net leverage was approximately 2 times.

Now moving on to our 2021 guidance update. Starting with revenue, we are adjusting our 2020-2021 constant currency revenue growth guidance to a range of 8% to 9% year-over-year compared to 8.5% to 9.75% previously. 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 had assumed.

Turning to currency; we continue to assume a 2% tailwind to reported revenue from foreign exchange rates in 2021, 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% previously. The updated guidance would equate to $1 range of between $2.791 billion and $2.816 billion.

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% and 59.5%. On a year-over-year basis we expect gross margin expansion to be driven primarily by a favorable mix of high margin products, including interventional urology, interventional access and surgical programs partially offset by inflation. Relative to our prior guidance, the revised outlook is associated with lower UroLift remittance. There’s no change to our expectation at Z-Medica 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 time. The majority of those contracts expired at the end of September with remainder expiring at the end of the year. As a result of the expiring shipping contracts and increasingly inflation we now estimate that inflationary cost will be roughly $3 million higher in the fourth quarter than what was incurred in the third quarter. 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&L. We now expect interest expense to be roughly $57 million versus our previous guidance of $60 million to $62 million, partly reflects a reduction in debt, funded by proceeds from the respiratory divestiture and our strong cash flow generation. 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% to 25.1% year-over-year increase.

And that concludes my prepared remarks.

I would now like to turn it back to Liam for closing commentary. Liam?

[Liam Kelly, Chairman, President and Chief Executive Officer]

Thanks Tom.

In closing, I will highlight our three key takeaways from the quarter. First, our diversified product portfolio enables Teleflex to deliver double-digit constant currency growth in the third quarter, even with greater than expected disruption from COVID-19. Second, 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&A. Third, we raised our earnings per share guidance for 2021, reflecting 23% to 25% earnings growth year-over-year.

In closing, we feel good about our overall performance in the quarter, which was anchored by our diversified portfolio of medically necessary products. Our balance sheet is in a solid position which leverage at 2 times 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.

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

[Operator]

Thank you. [Operator Instructions] And now our first question comes from Matt Taylor from UBS. You’ll answer open.

[Matt Taylor]

Hey, good morning. Thanks for taking the question. The first thing I wanted to ask you about was what you’re assuming for Q4 and recent trends? In – from the commentary that you made about the environment it seems like you’re assuming stability with some of this 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?

[Liam Kelly, Chairman, President and Chief Executive Officer]

Matt, thank you very much for the question. I think that as we look into the fourth quarter, we have to start with what we saw in the third quarter, 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 Intervention Access and Surgical were impacted by COVID. We still met expectations for revenue in that tough environment and exceeded our expectations on margins and EPS. I mean, EPS actually grew 27% within the quarter.

And Q3 would deliver growth of 10.3% over 2020, and nearly 6% over 2019. 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 a 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%, and [indiscernible] grew 12%, [indiscernible] grew 10% and to your question, as we’ve progressed through the quarters, procedure volume did not recover in-line with our original expectation and we’re 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 attributable 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 specifics of Q4 Matt because there’s only one quarter left and clearly our guidance outlined what we’re expecting in Q4 from all aspects of our business.

[Matt Taylor]

Okay. All right. Thanks. Make me elect all that color. Maybe I could just ask you one question about the UroLift reimbursement and obviously we’ll see what happens here over the next week or so would the final outcome of the orthopedics 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 be to do under some of those different things that could – could happen to help physicians maintain their business in the office or move it to the AFB if they have to?

[Liam Kelly, Chairman, President and Chief Executive Officer]

Yes. So you’re correct Matt, there is no update as we sit here today and we would expect the proposed ruling to come through in early next month. That’s the normal timeline for us. 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 the 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 duty bound to take all the comments into consideration. We, when their final ruling comes out, 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. 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 the procedure in an office have parent ownership or access to an ASC and have that level of flexibility. So we’ll wait for the final ruling, Matt, and then we will make a decision on how we will proceed. But rest assured, plans are, of course, within Teleflex to move quickly once we get the final ruling.

[Operator]

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

[Cecilia Furlong, Morgan Stanley]

Hey, good morning. And thank you for taking the questions. Liam, 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 are looking at the environment today from a deferral, recapture perspective versus what played out in the March, April timeframe?

[Liam Kelly, Chairman, President and Chief Executive Officer]

Yes. So, I’ll started with the last bit 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. And from that, we do anticipate 150% the number of impressions and we’re well on track [indiscernible] three quarters to get to those number of impressions. The number of patients responding through the campaign continues to have a similar uplift and we’re really encouraged by that.

What we see as we go into the future, as I said earlier, is that the low end of the range implies the flat-lining of our September run rate for the remainder of the year. Now, Cecilia to your point on the 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 deductible 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. I mean, I think, that’s the most important thing. There’s still 12 million men that suffer with BPH. Urolift is still the go-to product for the treatment of BPH. And we still only done party just over 300,000 procedures, all of those 12 million men. And we still only trained 3,000 out of the 12,000 urologists. So, we’re still have a significant, a massive opportunity to continue to convert that customer base.

And our own observation is that the procedures just deferrable more so than we would’ve 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, restrictions and fear of COVID. I think number two, scheduled procedures that are subsequently canceled. And number three, and the lesser impact is really [indiscernible].

[Cecilia Furlong, Morgan Stanley]

Okay, understood. I didn’t want to ask just on staffing shortages as well, and 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, that I’m just curious if you’ve seen similar trends or is that stayed more in line with your traditional breakout? Thank you.

[Liam Kelly, Chairman, President and Chief Executive Officer]

Thank you. It’s pretty aligned with what we saw traditionally Cecilia regarding that we do see daycare procedures in hospitals rebounding and that’s one of the trends that we’ve seen. Regarding your question in 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 the issue that a lot of the ancillary workers that are within the office, the AAC and the hospitals, and a lot of those people, unfortunately were furloughed in the midst of COVID. They have 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.

[Anthony Petrone, Jefferies]

Great, thanks. And good morning, everyone.

[Liam Kelly, Chairman, President and Chief Executive Officer]

Good morning.

[Anthony Petrone, Jefferies]

Maybe Liam, just a high level on the nursing shortages where 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? 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.

[Liam Kelly, Chairman, President and Chief Executive Officer]

Yes Anthony, I think, there is a difference inside of service, quite frankly. In the hospital environment, my observation is that the staffing shortages is 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. 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 up to other jurisdictions.

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 furloughs in the midst of COVID, because office – a doc working in an office is like a small business. So, they have to try and protect their cash flow, they furlough the people. Those people went down to government assistance. Now the government assistance dried up in around September that timeframe.

So, I would anticipate that would probably rebound a little bit faster simply because those individuals would want to come back to the workforce in order to generate an income. So that’s how I would see it. 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.

[Anthony Petrone, Jefferies]

Appreciate that. And just a 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 a deferral of procedures through the Delta? And so as you mentioned earlier, the high – there’s a high probability that these are recaptured over the next couple of quarters. Thanks, again.

[Liam Kelly, Chairman, President and Chief Executive Officer]

I would say, we have very high degree of confidence, Anthony, it has nothing to do with CMS. The CMS ruling won’t come in until next year, if 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 open.

[Jayson Bedford, Raymond James]

Hi, good morning. Just a couple of UroLift questions, not to get too granular, but is there 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?

[Liam Kelly, Chairman, President and Chief Executive Officer]

Yes. So I think that we have very strong presence in Florida and Texas are two of our key markets for UroLift 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 that the main impact of Jayson of the – in UroLift in the quarter is simply the Delta variant. It’s simply 28 states have imposed restrictions.

Now we would have thought that as we went through September, we would have anticipate some of those states reducing the restrictions, and we would have expected them this month October that, that they would have also been removing restrictions. And as I said earlier, it is a very deferrable procedure. I personally know two 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. 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.

[Jayson Bedford, Raymond James]

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 think the debate will turn to the level of durable growth with this business – market has changed, but you did mention normalized growth if you…

[Liam Kelly, Chairman, President and Chief Executive Officer]

Deal with the your reference that durable growth and let’s refer next two minutes, we grew 10.3% earnings per share growth in the third quarter. And as you move into the fourth quarter, I’m going to compare ourselves back to 2019, because that’s a better base year for me. We’re – we grew 6% – in the midst of COVID, the advantage of a diversified portfolio is allowing us to pose real positive growth with real half the earnings are as a result of that.

Regarding your question on the durable, what is durable growth for UroLift, obviously, we’re going to give guidance when we get through the fourth quarter. I want to see how the fourth quarter plays out. I am keeping an eye on this new variance that has raised a test in the UK and in Israel. I would want to make sure that that doesn’t become an issue and become Delta part two, as we go through the fourth quarter. 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…

[Operator]

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

[Drew Stafford, Piper Sandler]

Yes. Hi guys, this is 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. I mean in your deck, you expect or you mentioned that you expected double your impressions in 2020, here in 2021. But your revenues are obviously like that pays significantly and obviously, I think it’s obvious that COVID plays a big part in that. But you just have a sense for where those patients are currently going today. Are they getting into the doctor’s office and being seen, but the procedure they’re being deferred due to COVID or are they facing logistical issue even getting to that point.

[Liam Kelly, Chairman, President and Chief Executive Officer]

Thank you. So we know for a fact that they’re going to the doctor’s office, we know that because we actually direct them to the doctors. So they’re under the care of that doctor now. Again, the impact is simply COVID. You’ve got restrictions in 28 states. You’ve got people that are not comfortable quite frankly going in to have a procedure. And that, that is the impact. 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 one 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 expectation for impressions with the investment we’re making is 150%. And through three quarters of the year, we are well on track to achieve that level of impression. So we’re very encouraged by the DTC, we’re in burning calories by an engagement, and it was also nice to get the bronze award for the advertisement itself.

[Drew Stafford, Piper Sandler]

Helpful, thank you. And then just to kind of follow-up on that point a little bit just on the competitive landscape, Boston talking about good progress with resume Olympus rolling out good productive 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 this space and any sense for if your customers are taking a look at some of the newer products. Thank you.

[Liam Kelly, Chairman, President and Chief Executive Officer]

So I would read those comments closely, because they combined two 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 to 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.

[Matthew Mishan, KeyBanc]

Hey, great. Good morning, guys. I wondering source the conversation over to the margin side, gross and operating margins. I think, Tom, you laid out, I mean, mostly a miracle locked in freight contracts, like the last December regulations on doing that. But they’re actually running – they’re – those are kind of – those are done at this point. How should we think about the headwind into the fourth quarter and really into 2022 of that excess freight and logistics, as well as sort of lagging costs of materials that end up getting into your numbers as you kind of move forward?

[Thomas Powell]

Well, I would say that, as a result of locking 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 fourth quarter I cited $3 million 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 overall logistics.

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

[Matthew Mishan, KeyBanc]

Okay, excellent. And then on the Japan reimbursement for UroLift, with you now scheduled to the meeting in November, were you scheduled previously for it in September, and then it didn’t take it up or they took it off a bit. We’ll move it to November. What’s the logistics of why it was delayed by next couple of months?

[Thomas Powell]

No, it’s not a live a couple of months. It’s a – they write out to companies and give them their, their time they’re going to review it. We got ours then it was November in all transparency. We tell it, it was going to be October, but it was November. And we’re really happy that they’re going to review it. Then, it’s a $2 billion mark. It’s a great opportunity for us. We’ve already done the pre-market work and in the marketplace and we expect to ramp as we go through 2022.

And we didn’t anticipate any revenue in the fourth quarter in our original guidance to saw. We feel really encouraged 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 to, we’ve already done a limited market launch. We’ve been down there, we’ve actually trained some surgeons. We’ve got proctors already trained within the region. And we feel really good about both Japan and UroLift. And we feel very good about the international expansion of UroLift under the global marketplace, which is as big an opportunity as the U.S. market once we started to ramp oversee.

[Matthew Mishan, KeyBanc]

Thanks, Tom.

[Operator]

Your next question comes from Michael Matson from Needham & Company. Your line is open.

[Michael Matson, Needham & Company]

Yes, thanks. Just want to follow up on 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?

[Liam Kelly, Chairman, President and Chief Executive Officer]

Mike, thanks for the question. In a word, yes. We’ve seen positive pricing through the first three quarters of the year. We – I agree with you. We’re one of the few companies that he’s able to take positive pricing. We’ve taken some this year in order offset some of the inflation that we’ve seen. And if you look at our margin progress today, it’s reflected in that. You can see, how well we’re doing from a margin in an inflationary environment.

As we get to next year, we’ll get to next year, but it wouldn’t 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.

[Michael Matson, Needham & Company]

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 rain and is that still your thinking on it.

[Liam Kelly, Chairman, President and Chief Executive Officer]

Unfortunately, it’s out of my control right now, because it’s with the FDA. We’ve got our submission in to continue to engage with them. It’s unchartered waters by the FDA. This is a – they’ve never approved a biologic like this before, but they’re -- they continue to engage with as they continued to be helpful. And obviously, we’ll update the investment community, Mike, as soon as we’ve used 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.

[Lawrence Keusch]

Thank you, operator, and thank you to everyone that joined us on the call today. This concludes the Teleflex incorporated third quarter of 2021 earnings conference call.

[Operator]

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