Liam J. Kelly
Chairman, President and Chief Executive Officer at Teleflex
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 trends 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 and broad global footprint helped offset pressure on product revenues associated with elective surgery that were subject to pauses during the third quarter. As many investors will 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 insulated 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 delta 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 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 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 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 health care worker shortages. Accordingly, we believe that it is prudent to assume that COVID-19 will remain a headwind and that a 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 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 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 benefit of our diversified portfolio and was driven by contributions from all business segments, offset 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 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-19, including Interventional Urology, Interventional and Surgical. Third quarter growth and operating margin performance exceeded our expectations reflecting the strength of our diversified portfolio, partially offset 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 for deleveraging 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 demonstrates the resilience of 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. All growth rates that I referred 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 of $143.9 million increased 3.6% year-over-year with Interventional and Vascular products leading the growth. EMEA benefited from a favorable COVID-19-related 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 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 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 third quarter. Starting with Vascular Access. Third quarter revenue increased 8.5% to $175.5 million. Our category leadership in central venous catheters and midlines, along with our novel coated PICC portfolio, continues to position us for dependable growth.
Our Vascular Access portfolio remains important in the treatment of COVID-19 patients, driving strength in the third quarter due to increased rates of coronavirus infections. Our PICC portfolio continues to perform well with 10% growth year-over-year. We continue to invest behind our differentiated PICC portfolio and are taking market share. Intraosseous was also solid in the third quarter with growth up 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 slowed complex PCI and TAVR procedures. We continue to invest behind our interventional portfolio, including complex catheters and MANTA, our large-bore closure device. MANTA momentum remains strong, 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 for MANTA, we are confident in our ability to achieve 8% share in 2021 of the $200 million to $300 million global market opportunity.
Turning now to Anesthesia. Third quarter revenue was $97.1 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 was stronger than in the prior year period, partially offset by the impact of the Delta variant in select geographies. For Interventional
Urology, third quarter revenue was $83.1 million, an increase of 1.5% year-over-year and below our expectations at the time of the quarter two conference call. The quarter was impacted by elective 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. We are closely monitoring trends in our UroLift business. Importantly, our analysis of commercial and Medicare billing claims over the past six 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-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, which 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. 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 third quarter revenue performance. Turning to some commercial updates and starting with UroLift. In the third quarter, we trained 124 urologists. Interest in UroLift remains strong, and with over 355 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. 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 fourth quarter. We recently won a bronze award for best new branded television campaign from DTC perspective, which is a meaningful accomplishment given 13 finalists. Search interest for UroLip remains high and well above other minimally invasive BPH treatments with the majority of urologist surveys continuing to report patients asking for the UroLift System.
Moving to UroLift 2. We remain on a full rollout in the United States. We've 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 two by the end of 2022, fueled by advantages in tissue compression, reduced storage space and increased manufacturing capacity. UroLift two remains an important margin driver as we remain 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 has 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 1/3 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 have been expecting to enter Brazil in late 2022, we have been able to shorten our time line with a limited market release late in the third quarter 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 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 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 procedures to more costly sites of service. Teleflex, along with numerous other stakeholders, have urged 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 route. 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 recently launched Arrow ErgoPack kit, which contributed 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 is kink-resistant and an enhancement that clinicians find beneficial. Given our leading market share in CVCs, the launch is a trade-up strategy that drives incremental gross profit dollars and helps sustain our dominant market leadership position in CVCs.
Lastly, on our acquisition of Z-Medica, which was completed in December of 2020. The integration of 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 hemostat portfolio, we have completed patient enrollment in a 231-patient IDE study, evaluating the performance of QuikClot Control+ hemostatic devices from mild-to-moderate bleeding in cardiac procedures as compared to standard goals. We intend to file a 510(k) for expanded use of QuikClot 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?
