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Text: Additionally, during this conference call, you will hear management make references to the estimated positive or negative impact that COVID-19 had on our operations during the fourth quarter and full year of 2020.
You'll also hear management make statements regarding intra-quarter business performance during the first quarter of 2021.
Management is providing this commentary to provide the investment community with additional insights concerning trends and these disclosures may not occur in subsequent quarters.
It's a pleasure to speak with you today.
I'd also like to take a moment to again recognize the Teleflex employees around the world.
This past year has been challenging, but our team has done a tremendous job serving our customers and patients globally, overcoming obstacles to manufacture and distribute our products to the people that need them most.
Now turning to our results.
Considering the volatile environment we operate in, we are pleased with our Fourth quarter performance as our business did better than we expected and trends continued to improve across many of our product categories and geographies.
We saw better-than-expected sequential improvement from quarter to 2 quarters and from quarter 3 to quarter 4.
Despite a rising number of COVID-19 infections that occurred throughout the fourth quarter, the recovery in our business was led by product lines that were initially most negatively impacted by COVID-19, those being our Interventional Urology, Interventional Access and Surgical businesses as well as continued strength within our Vascular Access and other product categories.
While from a regional perspective, we saw strength within the Americas as well as positive growth within EMEA and improving trends in Asia.
Quarter four revenues totaled $711.2 million, which represents an increase of 2.3% as compared to the prior year period on a constant currency basis.
Growth in the quarter was aided by 2 additional selling days, which we estimate contributed approximately 3% points.
Excluding the impact of the additional selling days, we estimate that our constant currency revenues declined approximately 1%.
The days adjusted declines reflect continued recovery progression relative to the 4% decline we experienced during the third quarter of the year and the 12% decline we experienced during the second quarter of the year and it was ahead of the expectations we had at the time of the third quarter earnings call.
During the fourth quarter, we estimate that headwinds associated with COVID-19 caused a net negative impact of approximately $61 million or approximately 9%.
if we were to normalize for the negative impact, we estimate that our underlying business grew by approximately 11% on a constant currency basis, or 8% when normalizing for the selling day impact.
In addition to seeing continued sequential improvements in our constant currency revenue performance during Q4, we also saw a significant sequential improvement within our adjusted gross and operating margins as compared to the second and third quarters of the year.
This improvement drove adjusted earnings per share, which exceeded our internal expectations.
Lastly, I am happy to announce that on December 28th, we closed the acquisition of Z-Medica a market leader in hemostatic products.
We are pleased to be able to deploy capital for a differentiated product portfolio that leverages the existing Teleflex call points and is immediately accretive to our revenue growth rates, adjusted gross and operating margin profile and our adjusted earnings per share.
Turning to a more detailed review of our fourth quarter results.
As I just mentioned.
Quarter four revenue grew 2.3% on a constant currency basis and 4.4% on an as reported basis.
The increase in revenue was driven by our Vascular Access Portfolio, which saw some tailwinds in terms of COVID- related purchasing and solid mid single-digit growth of Interventional Urology and our other segment.
From a margin perspective, we had generated adjusted gross and operating margins of 58% and 26.6% respectively.
This translated into a year-over-year declines of 120 basis points at the gross margin line and 50 basis points at the operating margin line.
However, from a sequential standpoint, this represented an improvement of[Phonetic] AZ[/Phonetic] and 150 basis points respectively compared to quarter three levels.
On the bottom line, adjusted earnings per share was $3.25.
Overall, our financial performance in the quarter demonstrates the sustained resilience of our diversified global product portfolio and it gives us confidence in our ability to achieve our long-term financial objectives once we get past COVID-19.
Let's now turn to a discussion of our quarterly revenue trends, which will be on a constant currency basis.
The Americas delivered revenues up $419.5 million in the fourth quarter, which represents an increase of 5% over the prior year period.
Growth within the Americas was driven by Vascular Access and respiratory products which both saw elevated demand driven by COVID.
In addition, Interventional Urology was a strong contributor as UroLift continues to be our fastest recovering procedure.
However, there were offsets with declines in other product categories.
We estimate that the Americas would have grown approximately 12% excluding the impacts that COVID-19 had on the region.
EMEA reported revenues of $161.4 million in the fourth quarter, representing growth of 4.1%.
During the quarter, EMEA benefited from a one-time order of tracheostomy products and from the [Phonetic]extra [/Phonetic]selling days, the combination of which more than offset our estimated 1% COVID headwinds.
Revenues totaled $78.6 million in the fourth quarter, which represents a decline of 7.2%; however, we estimate that we would have had positive constant currency revenue growth in the mid-single digits, if not for the impact of COVID-19.
Additionally during the fourth quarter, we finished transitioning a distributor in Japan.
When normalizing for both COVID and the distributor change, growth in the region would have been in the mid to high single-digit range.
And lastly, our OEM business reported revenues up $57.7 million in the fourth quarter, which was down 6.9% on a constant currency basis.
As we anticipated during the fourth quarter, our OEM business saw aligned impact related to COVID relative to our other businesses.
Investors familiar with Teleflex will be aware that our OEM business supplies device companies with complex catheters and surgical sutures and the quarter four impact reflects reduced orders from these customers whose business is tied to non-emergent procedures.
Excluding the impact COVID-19 had, the business grew roughly 31%, which includes a benefit of approximately 13% from the acquisition of HPC.
As it relates to HPC, I am pleased to report that we remain on track with our integration efforts.
Let's now move to a discussion of our revenues by global product category.
Starting with Vascular Access, fourth quarter revenue increased 16% to $182.5 million.
We estimate that COVID-19 positively impacted the growth rates of our vascular products during the fourth quarter by approximately 5%.
Key drivers of revenue growth included PICC, which increased approximately 20%, CVCs which increased approximately 16% and EZ-IO which grew approximately 14%.
Moving to Interventional Access, fourth quarter revenue was $106.7 million or down 6.9% as compared to the prior year period.
The decrease was largely due to the delay in the recovery of certain non-emergent procedures because of COVID 19 along with the negative impacts stemming from a catheter recall and distributor conversion in Japan, both of which began last quarter.
We estimate that the recall and distributor issue impacted our business negatively by approximately $3 million.
We expect the impact on the recall to continue to linger for the next few quarters as we do not expect to be back on the market with this product until September of this year while the distributor inventory headwind should reverse and be a modest tailwind for us in 2021.
When normalizing for the impact that COVID had along with the aforementioned headwinds, we estimate that underlying growth was in the high single digits consistent with our long-term growth outlook for the segment.
In addition, we are pleased that Manta grew 33% globally in quarter four.
Now turning to Anesthesia, revenue was $86.1 million, which is lower than the prior-year period by 2.1%.
The revenue decline was the result of lower sales of laryngeal masks and endotracheal tube products.
We estimate that COVID had an approximate 1% negative impact in the quarter, implying flattish performance on an underlying basis.
Since we closed the Z-Medica acquisition just days before year-end, it's impact was immaterial on quarter four results.
Revenues declined by 5.7% to $92.3 million driven by lower sales of our ligation portfolio.
We estimate a 9% headwind from COVID during quarter 4 indicating recovery as compared to the estimated 13% COVID headwind in quarter three.
Moving to Interventional Urology.
Quarter four revenue increased by 5.3% to $93.9 million, which represents a new high watermark in terms of revenue dollars in any given quarter.
On a year-over-year basis, the business faced a difficult growth comparison but sequentially, it grew by 15% versus quarter three.
We estimate an approximate 28% COVID-19 related headwind during quarter four.
Notwithstanding the significant headwind on our growth in quarter four, we are pleased with the path to recovery for this business unit and are also happy with the impact of the national DTC campaign, which is exceeding our expectations.
Additionally, we are encouraged that we trained approximately 130 new urologists in quarter four moving to a cadence that is consistent with our expectations prior to COVID and a positive leading indicator for future growth.
And finally, our other category, which consists of our respiratory and urology care products grew 6.1% totaling $98.1 million.
We estimate the growth during the quarter was partly due to increased demand for certain humidification and breathing products resulting from COVID-19 mainly in the Americas.
That completes my comments on quarter four revenue performance.
Turning to some recent clinical and commercial updates.
Starting with UroLift, the response to our national DTC campaign is exceeding our expectations.
The strategic role of DTC is important as about half of the 12 million men being treated for BPH believe prescription medications are their only solution.
Overall, we view the pilot national DTC as a successful campaign.
Key statistics include a doubling of brand awareness among men age 45 are higher post campaign versus pre-campaign levels.
Approximately 150% increase in visits to UroLift.com during the campaign and direct response numbers that exceeded our internal projections by a wide margin.
Lastly, we know that Google search trends demonstrate a significant and sustained increase in response to the campaign.
As such, we expect to continue the national DTC effort in 2021 and beyond.
Turning to UroLift too.
We have completed the market acceptance test and received positive feedback across more than 100 procedures completed by 20 urologists.
We have begun a full controlled launch.
The launch is controlled due to restrictive access caused by COVID-19.
This will ensure we don't disrupt growth recovery with a more fulsome rollout beginning in the second half of 2021.
We remain confident that conversion to the UL2 will occur over time and we continue to expect to generate significant margin expansion as the revenue base is fully converted.
Regarding Japan, we remain on track for reimbursement decision in 2021 and view the approximate $2 billion addressable market as an incremental growth driver, that will be a positive catalyst for seeable future.
Overall between nationwide DTC, Japan rollout, and the launch of UL2, we have multiple drivers to build momentum as we seek to further expand our leadership position in BPH.
Turning to the next slide on key clinical updates.
Recently a comparative analysis of sexual function outcomes from UroLift studies and the Medical Therapy of prosthetic symptoms trial was published in the peer-reviewed journal European Urology Focus.
The comparison reveals that UroLift is superior to BPH medical therapy in preserving erectile and ejaculatory function and sexual satisfaction.
Importantly, this study challenges the idea that medical therapy is the most conservative treatment option for BPH.
Over time, we believe that more clinical research like this publication consider UroLift as a first-line therapy for treating BPH.
Turning to an update on Interventional Access.
Regarding the CTO-PCI study that we mentioned on our Q2 earnings call, I am pleased to announce that we have completed enrollment for this study.
This is a prospective, single-arm IDE study of 150 patients across 13 sites to evaluate the performance of the entire range of Teleflex coronary guidewires and specialty catheters in chronic total occlusion percutaneous coronary intervention procedures, which is the most demanding PCI environment.
Once the study results are finalized, we anticipate updated labeling for our Guidewire and Specialty Catheter products which can address an estimated 100,000 CTO-PCI procedures.
Overall, we continue to invest in clinical and commercial catalysts that will help to sustain our upper single-digit revenue growth aspirations in a normalized environment.
Lastly, turning to EZPlas.
I am happy to update the investment community that we successfully submitted our BLA to the FDA in late January.
We recently performed a market assessment update and still see a $100 million initial market opportunity for EZPlas.
We are increasingly confident in our ability to address this commercial opportunity with revenue likely ramping in early 2022.
In addition, we believe there are potential revenue synergy opportunities with Z-Medica to leverage their sales reps as well as our channel strength across the healthcare and government call points which could add to our baseline expectations, which brings me to an update on our latest acquisition.
On December 28th, we completed the acquisition of Z-Medica, an industry leading manufacturer of hemostatic products, that is a classic Teleflex deal and a great strategic fit.
Investors familiar with Teleflex will be aware that we aim to invest in innovative products and technologies that can meaningfully enhance clinical efficacy, patient safety and comfort, reduce complications, and lower the overall cost of care.
Given their differentiated products and attractive end markets, we view the Z-Medica acquisition like that of Vidacare from a few years ago.
Since we acquired Vidacare in 2013, we have more than double the sales which are still growing in the healthy double-digit range.
One difference is that Z-Medica is growing into a $600 million addressable market while Vidacare is addressable market was closer to $250 million.
Regarding our long-range financial targets.
Z-Medica only reinforces our ability to get to those goals, and we remain committed to delivering constant currency revenue growth of at least 6% to 7% on an annual basis and reaching 60% to 61% and 30% to 31% adjusted gross and operating margins once we return to a more normalized environment.
We plan to hold an Analyst Day event in the fall of this year, at which time we intend to provide updated long-term financial goals and timetables.
Given the previous discussion of the company's revenue performance, I'll begin with the gross profit line.
For the quarter, adjusted gross margin was 58%, a decrease of 120 basis points versus the prior year period.
The decrease in gross margin was primarily due to COVID-related impacts, including unfavorable product mix and higher manufacturing costs along with a modest foreign exchange headwind.
In total, we estimate that COVID negatively impacted our adjusted gross profit by approximately $44 million in the quarter.
We continue to tightly manage discretionary spending, partially offset the reduced revenue and gross profit resulting from COVID.
As a result of the efforts, we estimate that operating expenses were reduced in the fourth quarter by approximately $13 million.
For full year 2020, we managed opex lower by an estimated $78 million.
Fourth quarter operating margin was 26.6%, were down 50 basis points year-over-year.
Continuing down the income statement.
Net interest expense totaled $18.5 million, which is an increase of 10% year-over-year and reflects higher average debt balances versus the prior year period due to the acquisitions of HPC and Z-Medica.
Moving to taxes, for the fourth quarter of 2020, our adjusted tax rate was 10.1% as compared to 7.7% in the prior year period.
At the bottom line.
fourth quarter adjusted earnings per share declined modestly to $3.25 from $3.
28 a year ago.
Included in this result is an estimated adverse impact from COVID of approximately $0.55 and a foreign exchange tailwind of approximately $0.05.
Turning to select balance sheet and cash flow highlights.
In 2020, cash flow from operations was flat as compared to 2019 totaling $437.1 million.
We are pleased with this outcome given COVID headwinds and increased contingent consideration payments that flowed through cash flow from operations in 2020 as compared to 2019.
Overall as we exited 2020, the balance sheet remains in good shape.
At year-end, our cash balance was $375.9 million as compared to $301.1 million as of December 2019.
Over the course of the year, we deployed more than $750 million for external business development opportunities.
We'll continue to balance our investments across both organic, inorganic initiatives to fuel our growth and drive margin expansion with M&A as our primary focus for capital deployment.
Inclusive of Z-Medica financing, we net leverage ended 2020 at [Phonectic]2.98 times[/Phonetic ], which remains well below our 4.5 times covenant.
Lastly, we have no near-term debt maturities of material size.
In summary, despite facing the challenging operating environment during 2020, the organization adapted quickly and executed well.
We remain optimistic toward the future and expect to recovery beginning in the second half of 2021.
As such, we are reinstating financial guidance for 2021.
To begin, I'll provide a framework of key assumptions underlying our financial guidance.
Our outlook contemplates COVID disruption continuing through much of the first half of the year, with the second half of the year much closer to a normal operating environment.
Our baseline assumption assumes that healthcare systems can manage through incremental COVID surges while applying past learnings to avoid widespread procedure shutdowns.
It also excludes any material regulatory, healthcare or tax reforms, as well as any future M&A.
Lastly from a selling day perspective, we will have 2 fewer selling days in the first quarter as compared to the year-ago period, we will have one additional day in the 4th quarter as compared to the year-ago period, and there will be no differences in the number of days during the second and third quarters.
In 2021, we project constant currency revenue growth between 8% and 9.5% as compared to 2020.
We expect our Interventional Access, Surgical and Vascular Access product offerings to be key contributors to our constant currency revenue growth during 2021.
We also expect our Interventional Urology business to increase at least 30% over 2020 levels.
Additionally, Z-Medica is expected to contribute $60 to $70 million of revenue or approximately 2.5 points of growth.
We expect foreign currency exchange rates will be a tailwind to revenue growth of approximately 2%.
As a result, we expect our as-reported revenue to increase between 10% in 11.5% over 2020 and this would equate to $1 range of between $2.791 million and $2.829 million.
Turning next to gross margin.
During 2021, we anticipate that adjusted gross margin will increase between 130 and 230 basis points to a range of between 8% and 59%.
We expect gross margin expansion will be driven primarily by a favorable mix of high margin products primarily, Interventional Urology as well as the acquisition of Z-Medica which will add approximately 50 basis points to gross margin.
Moving to adjusted operating margin.
During 2021, we anticipate that adjusted operating margin will increase between 110 and 210 basis points to a range of between 26% and 27%.
The increase in adjusted operating margin will be sourced from the gross margin expansion, partially offset by normalization of certain 2020 COVID-related spending reductions, which were temporary in nature as well as further strategic investments into UroLift and Manta.
Additionally, the acquisition of Z-America is expected to provide a modest tailwind to year-over-year operating margin expansion.
Given the relatively higher opex cost structure of Z-0Medica versus Teleflex, operating margin accretion from Z Medica will be less than the 50 basis points of gross margin accretion.
That takes me to our adjusted earnings per share outlook for 2021.
This slide serves as a bridge for our full-year 2020 adjusted earnings per share results to our full-year 2021 adjusted earnings per share outlook, beginning with the 2020 adjusted earnings per share of $10.67.
From an operating standpoint in 2021, we project additional earnings between $1.58 and $1.66 per share or an increase of approximately 15%.
Our 2021 earnings per share guidance also assumes the following: Foreign exchange is planning to [Indecipherable] for key currencies including a full year euro to dollar exchange rate of $1.21.
For 2021, foreign exchange is expected to provide a tailwind of approximately $0.35.
We now project Z-Medica to contribute between $0.21 and $0.26 of adjusted earnings per share in 2021, and this is an increase from our original expectation, which call for contribution of between $0.07 and $0.15.
The increase in the Z-Medica accretion is due to the change in our planned approach for financing the acquisition, which we now believe to be done through a combination of borrowings under our revolver and free cash flow versus a previous expectation for bond offer.
In 2021, we expect interest expense to range between $63 and $65 million/.
The year-over-year reduction in interest expense is expected to contribute between $0.17 and $0.19 of earnings accretion if you would exclude the incremental financing costs for Z-Medica.
During 2021, we project that our adjusted tax rate will be in the range of 13.5% and 14% and will result in adjusted earnings per share headwind of between $0.33 and $0.38.
The projected year-over-year increase and the adjusted tax rate is a result of a greater expected mix of US taxable income principally resulting from UroLift growth and certain 2020 tax benefits that we do not expect to reoccur in 2021.
Additionally, our assumption is that 2021 windfall benefit from stock based compensation is at a reduced level versus the typically high level realized in 2020.
We estimate that weighted average shares will increase to $47 million for full year 2021 which is diluted by approximately $0.10.
Despite several headwinds, our adjusted earnings per share outlook of $12.50 to $12.70 is robust, representing growth of between 17.2% and 19% versus 2020.
Given the expectation of continued COVID impact into 2021, I'll highlight some considerations regarding quarterly expectations.
As I mentioned previously, our outlook is predicated on the assumption that COVID will continue to cause disruption during the first half of the year with a particular negative impact during the first quarter.
Additionally, the first quarter of 2021 has few fewer selling days as compared to 2020.
In closing, we delivered solid fourth quarter results as our diversified portfolio showed continued improvement relative to the second and third quarters of the year on both the top and bottom lines.
Excluding the impact of COVID, we see our underlying business performance as encouraging and while the next several quarters still will have elements of uncertainty, we remain confident in our ability to execute in 2021 and are up [Technical Issue] and we'll continue to focus on serving our hospital customers and working with our key stakeholders.
We are excited about the prospects for our business.
We have several revenue drivers including UroLift, Manta, Z-Medica, PICC, Vidacare, EZPlaz and HPC to name but a few.
We will manage the business prudently while staying focused to capitalize on the long-term potential of our global product portfolio.
As an organization, we remain well positioned to create value for all our stakeholders.

user
estimates negative impact from covid-19 on q4 emea revenue of about $1 million (not sees q4 2020 revenue about $1.0 million).
q4 adjusted earnings per share $3.25 from continuing operations.
q4 revenue $711.2 million versus refinitiv ibes estimate of $687.7 million.
sees fy 2021 adjusted earnings per share $12.50 to $12.70 from continuing operations.
sees fy 2021 revenue up 10 to 11.5 percent.

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