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Operator
Operator
Good morning, ladies and gentlemen, and welcome to the Teleflex Fourth Quarter of 2021 Earnings Conference Call. (Operator Instructions) Please note that this conference call is being recorded and will be available on the company's website for replay shortly.
女士們先生們,早上好,歡迎來到 Teleflex 2021 年第四季度收益電話會議。 (操作員說明)請注意,此電話會議正在錄製中,很快就會在公司網站上重播。
And now I would like to turn the call over to Mr. Lawrence Keusch, Vice President of Investor Relations and Strategy Development.
現在我想把電話轉給投資者關係和戰略發展副總裁 Lawrence Keusch 先生。
Lawrence Soren Keusch - VP of IR & Strategy Development
Lawrence Soren Keusch - VP of IR & Strategy Development
Good morning, everyone, and welcome to the Teleflex Incorporated Fourth Quarter 2021 Earnings Conference Call. The press release and slides to accompany this call are available on our website at teleflex com. As a reminder, this call will be available on our website, and a replay will be available by dialing (800) 585-8367 or for international calls, (416) 621-4642 using passcode 1028958.
大家早上好,歡迎來到 Teleflex Incorporated 2021 年第四季度收益電話會議。本次電話會議的新聞稿和幻燈片可在我們的網站 teleflex com 上獲取。提醒一下,我們的網站上將提供此通話,撥打 (800) 585-8367 或使用密碼 1028958 撥打國際電話 (416) 621-4642 可重播。
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.
參加今天電話會議的有董事長、總裁兼首席執行官 Liam Kelly;執行副總裁兼首席財務官 Thomas Powell。 Liam 和 Tom 將提供準備好的評論,然後我們將開啟問答環節。
Before we begin, I would 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.
在我們開始之前,我想提醒您,電話會議中討論的一些事項將包含有關我們幻燈片中概述的未來事件的前瞻性陳述。我們謹提醒您,此類陳述實際上具有前瞻性,並受風險和不確定性的影響,實際事件或結果可能存在重大差異。可能導致實際結果或事件發生重大差異的因素包括但不限於我們今天的新聞稿中提到的因素以及我們向美國證券交易委員會提交的文件,包括我們的 10-K 表格,可以在我們的網站上訪問.在此電話會議期間,您將聽到管理層就季度內業務績效發表的聲明。管理層提供此評論是為了向投資界提供有關趨勢的更多見解,並且這些披露可能不會在隨後的季度中發生。
With that said, I will now turn the call over to Liam for his remarks.
話雖如此,我現在將把電話轉給利亞姆聽取他的意見。
Liam J. Kelly - Chairman, President & CEO
Liam J. Kelly - Chairman, President & CEO
Thank you, Larry, and good morning, everyone. It's a real pleasure to speak with you today.
謝謝你,拉里,大家早上好。今天很高興與您交談。
For the fourth quarter, Teleflex generated 7.9% constant currency revenue growth year-over-year and increased 10.4% over the comparable period in 2019. In the quarter, there was 1 extra shipping day, which added approximately 1% to the year-over-year growth rate. Adjusted earnings per share rose 10.8% year-over-year.
第四季度,Teleflex 的貨幣收入同比增長 7.9%,比 2019 年同期增長 10.4%。本季度多出 1 個發貨日,同比增長約 1%年增長率。調整後每股收益同比增長 10.8%。
Our fourth quarter performance was driven by the company's balance of growth drivers, broad portfolio of medically necessary products and categories leadership, offset by the impact of COVID-19 and the divestiture of the respiratory assets. As we had anticipated at the time of our third quarter earnings report, COVID-19 remained a headwind during the fourth quarter, and elective surgical procedures did not return to comparable 2019 levels.
我們第四季度的業績是由公司的增長動力平衡、廣泛的醫療必要產品組合和類別領導地位推動的,但被 COVID-19的影響和呼吸資產剝離所抵消。正如我們在發布第三季度收益報告時所預期的那樣,COVID-19 在第四季度仍然是一個不利因素,擇期外科手術也沒有恢復到 2019 年的可比水平。
Specifically, COVID cases increased significantly during December in geographies with large populations, including the Northeast, Florida, Texas and California, as COVID spread quickly through these regions. We also saw increased staffing charges as COVID infections accelerated quickly in the latter portion of the quarter. Teleflex executed well in the quarter with dependable service levels to our customers while managing supply chain challenges, freight logistic delays and responding when COVID infection rates began to accelerate.
具體而言,由於 COVID 在這些地區迅速傳播,12 月份在人口眾多的地區(包括東北部、佛羅里達州、德克薩斯州和加利福尼亞州),COVID 病例顯著增加。我們還看到,隨著 COVID 感染在本季度後半段迅速加速,人員費用有所增加。 Teleflex 在本季度表現良好,為我們的客戶提供可靠的服務水平,同時管理供應鏈挑戰、貨運物流延誤以及在 COVID 感染率開始加速時做出響應。
Of note, when excluding UroLift, which is the product that was most impacted by the pandemic, revenues from the remaining business grew over 9% on a constant currency basis in the fourth quarter year-over-year.
值得注意的是,如果不包括受大流行影響最大的產品 UroLift ,第四季度剩餘業務的收入按固定匯率計算同比增長超過 9%。
Turning to our performance in 2021. Although the year presented challenges, I am proud to say that Teleflex executed very well. We confronted the unprecedented market disruption head-on as the pandemic continued to ebb and flow. We remain diligent and flexible in order to support our customer needs and keep our workforce safe. We responded effectively as freight and raw material supply challenges escalated through the year.
談到我們在 2021 年的表現。儘管這一年充滿挑戰,但我可以自豪地說 Teleflex 的表現非常出色。隨著大流行繼續潮起潮落,我們直面前所未有的市場混亂。我們保持勤奮和靈活,以支持我們的客戶需求並確保我們的員工安全。隨著貨運和原材料供應挑戰在這一年不斷升級,我們做出了有效的應對。
Throughout the year, we stayed true to our objectives by advancing our strategy of driving durable growth, expanding margins and remaining good stewards of our balance sheet. During the year, we invested in our growth drivers, executed on our overseas strategy and rolled out new products. Our customers remained our focus and Teleflex team members enabled us to supply customers with products necessary to care for their patients.
全年,我們通過推進推動持久增長、擴大利潤率和保持資產負債表良好管理的戰略,堅持我們的目標。年內,我們投資增長動力,執行海外戰略並推出新產品。客戶始終是我們關注的焦點,Teleflex 團隊成員使我們能夠為客戶提供護理患者所需的產品。
We continue to optimize our portfolio with the integration of HPC and Z-Medica acquisitions, and we divested certain low growth and low margin respiratory assets. And we did not take our eyes of our people as we fortified our culture and advanced our ESG initiatives. From a financial perspective, we delivered on our full year 2021 financial commitments with constant currency sales growth of 8.8%, adjusted operating margin expansion of 310 basis points and adjusted earnings per share of $13.33, a 24.9% increase year-over-year. None of this would be possible if it were not for the tireless efforts of the global Teleflex team. I would like to thank our employees for their hard work and dedication during 2021 and throughout the pandemic.
我們通過整合 HPC 和 Z-Medica 收購繼續優化我們的投資組合,我們剝離了某些低增長和低利潤率的呼吸資產。在強化我們的文化和推進我們的 ESG 計劃時,我們沒有關注我們的員工。從財務角度來看,我們兌現了 2021 年全年的財務承諾,貨幣銷售額穩定增長 8.8%,調整後營業利潤率增長 310 個基點,調整後每股收益為 13.33 美元,同比增長 24.9%。如果不是 Teleflex 全球團隊的不懈努力,這一切都不可能實現。我要感謝我們的員工在 2021 年和整個大流行期間的辛勤工作和奉獻精神。
Turning now to a deeper look at our fourth quarter revenue results. I will 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. During the fourth quarter, our Americas, EMEA, Asia and OEM segments demonstrated resilience with all regions showing constant currency revenue growth over 2020 when excluding the impact of the extra shipping day despite the continued headwinds from COVID. As I mentioned earlier, this underscores the benefits of our diversified product portfolio.
現在轉向更深入地了解我們第四季度的收入結果。我將從回顧我們的可報告分部收入開始。除非另有說明,否則我所指的所有增長率均以固定貨幣為基礎。在第四季度,我們的美洲、歐洲、中東和非洲、亞洲和 OEM 部門表現出彈性,儘管 COVID 持續不利,但排除額外運輸日的影響後,所有地區的貨幣收入在 2020 年保持穩定增長。正如我之前提到的,這凸顯了我們多元化產品組合的優勢。
Americas revenue was $451.7 million in the fourth quarter, which represents 7.6% year-over-year growth. Contributors to the year-over-year growth were Surgical, Vascular and Interventional, partially offset by the impact of COVID-19. EMEA revenues of $164.5 million increased 4.8% year-over-year with Interventional, Surgical and Vascular Access products leading the growth. EMEA continues to face a headwind from COVID-19. Although procedure volumes improved year-over-year as countries across the region continued to open up. Excluding the impact of the respiratory divestiture, revenues rose 8.7%.
第四季度美洲收入為 4.517 億美元,同比增長 7.6%。同比增長的貢獻者是外科、血管和介入,部分被 COVID-19 的影響所抵消。 EMEA 收入為 1.645 億美元,同比增長 4.8%,其中介入、外科和血管通路產品引領增長。 EMEA 繼續面臨來自 COVID-19 的逆風。儘管隨著該地區各國繼續開放,手術量同比有所增加。排除呼吸資產剝離的影響,收入增長 8.7%。
Turning to Asia. Revenues were $78.5 million, increasing 0.5% year-over-year. Excluding the impact of the respiratory divestiture, revenues rose 6.7%.
轉向亞洲。收入為 7850 萬美元,同比增長 0.5%。排除呼吸資產剝離的影響,收入增長 6.7%。
Let's now move to a discussion of our fourth 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.
現在讓我們按全球產品類別討論我們第四季度的收入。與我之前對我們可報告部門的評論一致,對全球產品類別增長的評論也將以固定貨幣為基礎,並按我們業務部門的規模排名。
Starting with Vascular Access. Fourth quarter revenue increased 6.4% to $193 million. Our category leadership in central venous catheters and midlines, along with our novel coated PICC portfolio continued to position us for dependable growth. The PICC portfolio continues to perform well with 11% growth year-over-year as we continue to invest behind our differentiated portfolio and are gaining market share. Intraosseous continues to be a dependable growth driver, with fourth quarter revenues rising approximately 17% year-over-year.
從血管通路開始。第四季度收入增長 6.4% 至 1.93 億美元。我們在中心靜脈導管和中線方面的類別領導地位,以及我們新穎的塗層 PICC 產品組合繼續使我們保持可靠的增長。隨著我們繼續投資於我們的差異化投資組合併獲得市場份額,人保財險投資組合繼續表現良好,同比增長 11%。骨內仍然是可靠的增長動力,第四季度收入同比增長約 17%。
Moving to Interventional. Fourth quarter revenue was $114.9 million, up 8.2% year-over-year. We executed well during the quarter and saw a strong demand for our complex catheters and balloon pumps. We continue to invest behind our interventional portfolio, including complex catheters and MANTA, our large foreclosure device. MANTA momentum remains strong, both in the U.S. and in international markets, with growth of approximately 45% year-over-year. Of note, we exceeded our objective for 8% share in 2021 of the $200 million to $300 million global market opportunity.
轉向介入治療。第四季度收入為 1.149 億美元,同比增長 8.2%。我們在本季度表現良好,看到了對我們的複雜導管和球囊泵的強勁需求。我們繼續投資於我們的介入產品組合,包括複雜的導管和我們的大型止贖設備 MANTA。 MANTA 在美國和國際市場的勢頭依然強勁,同比增長約 45%。值得注意的是,我們超額完成了 2021 年在 2 億至 3 億美元的全球市場機會中佔有 8% 份額的目標。
Turning to Anesthesia and Emergency Medicine. Fourth quarter revenue was $102.8 million, up 20.5% year-over-year. Hemostat products drove the growth in the quarter, offset by tough comparisons in the airway business and lower sales of tracheostomy products. For the full year, Hemostat revenues were approximately $66.5 million and fell squarely into the $60 million to $70 million range that we had established coming into 2021.
轉向麻醉和急救醫學。第四季度收入為 1.028 億美元,同比增長 20.5%。止血劑產品推動了本季度的增長,但被氣道業務的艱難比較和氣管切開術產品銷售額的下降所抵消。全年,Hemostat 的收入約為 6650 萬美元,完全落入我們為 2021 年確定的 6000 萬至 7000 萬美元的範圍內。
In our Surgical business, revenue was $106.4 million in the fourth quarter, representing 16.1% growth year-over-year. Among our largest product categories, we continue to witness robust growth in sales of our instruments and ligation clips as the elective surgical procedure environment was stronger than in the prior year period and hospital capital spending increased.
在我們的外科業務中,第四季度的收入為 1.064 億美元,同比增長 16.1%。在我們最大的產品類別中,我們的器械和結紮夾的銷售額繼續強勁增長,因為選擇性外科手術環境比去年同期強,醫院資本支出增加。
For Interventional Urology, fourth quarter revenue was $92.9 million, representing a decrease of 1% year-over-year and a 12% increase sequentially. This result was above the $85 million to $91 million implied guidance for the quarter. We saw a clear improvement in UroLift procedure trends during October and November when compared to the third quarter.
對於介入泌尿外科,第四季度收入為 9290 萬美元,同比下降 1%,環比增長 12%。這一結果高於本季度 8500 萬至 9100 萬美元的隱含指導。與第三季度相比,我們看到 10 月和 11 月 UroLift 手術趨勢有明顯改善。
However, December was negatively impacted year-over-year by the surge in COVID-19 with continued staffing shortages and an increase in procedure cancellations. Of note, we did not see any pull forward of UroLift procedures into the fourth quarter of 2021 from 2022, resulting from the announcement of the Medicare physician fee schedule final rule in November.
然而,由於人員持續短缺和程序取消增加,COVID-19 激增對 12 月產生了同比負面影響。值得注意的是,我們沒有看到 UroLift 程序從 2022 年提前到 2021 年第四季度,這是由於 11 月宣布了 Medicare 醫生費用表最終規則。
OEM revenues increased 3.9% year-over-year to $67.2 million in the fourth quarter as customer demand remains strong across our portfolio. We remain well positioned with broad capabilities in our markets, including faster growth opportunities in thin walls, advanced interventional microcatheters used in neurovascular and other applications.
由於客戶對我們產品組合的需求依然強勁,第四季度 OEM 收入同比增長 3.9% 至 6720 萬美元。我們在市場上擁有廣泛的能力,包括在薄壁、用於神經血管和其他應用的先進介入微導管方面更快的增長機會,從而保持有利地位。
And finally, our other category, which incorporates sales of respiratory products not included in the divestiture to Medline, Urology Care and manufacturing and supply transition agreement revenues declined by 12.2% to $84.7 million year-over-year. The decline reflects the loss of revenues due to the divestiture of the respiratory products, partially offset by manufacturing and supply transition agreement revenues and growth in Urology Care. We continue to expect manufacturing and supply transition agreement revenues to phase out at the end of 2023.
最後,我們的其他類別包括未包括在剝離給 Medline 的呼吸產品的銷售、泌尿科護理以及製造和供應過渡協議收入同比下降 12.2% 至 8470 萬美元。這一下降反映了由於剝離呼吸產品而導致的收入損失,部分被製造和供應過渡協議收入以及泌尿科護理的增長所抵消。我們繼續預計製造和供應過渡協議收入將在 2023 年底逐步淘汰。
That completes my comments on fourth quarter revenue performance. Turning now to some commercial updates and starting with UroLift. As we reflect on 2021, we continue to see COVID-19 as being the most disruptive force on the Interventional Urology business. Given the deferrable nature of BPH treatments, patient willingness can modulate depending on the severity of the pandemic. Our experience has shown that when COVID infections pick up, UroLift procedures are negatively impacted. And then recover when COVId case counts drop.
我對第四季度收入表現的評論到此結束。現在轉向一些商業更新並從 UroLift 開始。當我們回顧 2021 年時,我們繼續將 COVID-19 視為對介入泌尿外科業務最具破壞性的力量。鑑於 BPH 治療的可延期性,患者的意願可以根據大流行的嚴重程度進行調節。我們的經驗表明,當 COVID 感染增加時,UroLift 程序會受到負面影響。然後在 COVID 病例數下降時恢復。
In addition, staffing charges, which we identified in the second quarter created business disruptions, particularly in our office site of service. Importantly, our analysis continues to confirm that we have not lost share completing device-based treatment for BPH. For 2021, UroLift revenues increased 18% year-over-year despite the broader category for urology procedures remaining below pre-pandemic levels.
此外,我們在第二季度發現的人員費用造成了業務中斷,尤其是在我們的辦公地點。重要的是,我們的分析繼續確認我們沒有失去完成基於設備的 BPH 治療的份額。到 2021 年,UroLift 的收入同比增長了 18%,儘管更廣泛的泌尿外科手術類別仍低於大流行前的水平。
We continue to see UroLift positioned for accelerating growth as pandemic headwinds abate. COVID has remained a headwind early in the first quarter, but we anticipate improvement in sales trends throughout the year as elective surgical procedures become less disrupted. UroLift remains differentiated from other outpatient BPH treatments with strong clinical results, studies showing rapid symptom relief and recovery, no new sustained sexual dysfunction and durable results.
隨著大流行的逆風減弱,我們繼續看到 UroLift 有望加速增長。 COVID 在第一季度初仍然是一個不利因素,但我們預計隨著選擇性外科手術的中斷減少,全年銷售趨勢將有所改善。 UroLift 仍然有別於其他門診 BPH 治療,具有很強的臨床效果,研究顯示症狀迅速緩解和恢復,沒有新的持續性功能障礙和持久的結果。
Investors familiar with Teleflex will be aware that UroLift is being positioned for patients that are suffering with BPH and have failed or are not satisfied with drug therapy. In 2022, we will be intentionally laser-focused on improving utilization of existing UroLift users and driving increased productivity of surgeons that were trained in the midst of the pandemic. We will also fully engage our sales organization to advance the rollout of UroLift 2 with conversion of the vast majority of the U.S. users anticipated by the end of 2022.
熟悉 Teleflex 的投資者會意識到 UroLift 的定位是患有 BPH 並且對藥物治療失敗或不滿意的患者。 2022 年,我們將有意識地專注於提高現有 UroLift 用戶的利用率,並提高在大流行期間接受過培訓的外科醫生的工作效率。我們還將與我們的銷售組織充分合作,推進 UroLift 2 的推出,預計到 2022 年底,絕大多數美國用戶將實現轉化。
UroLift 2 remains an important margin driver, and we remain positioned to generate 400 basis points of UroLift gross margin expansion once the U.S. user base is fully converted. We believe that a tactical approach to moving our existing UroLift users back towards pre-pandemic procedure levels is the most efficient way to improve growth in 2022.
UroLift 2 仍然是一個重要的利潤驅動因素,一旦美國用戶群完全轉換,我們仍然有望產生 400 個基點的 UroLift 毛利率擴張。我們認為,使我們現有的 UroLift 用戶回到大流行前程序水平的戰術方法是促進 2022 年增長的最有效方法。
As for our consumer marketing efforts, we continue to view direct-to-consumer as a multiyear catalyst for UroLift in the U.S. For 2021, we exceeded all of our internal targets for the DTC campaign, and I would like to share a couple of highlights. Impressions increased nearly 200% year-over-year and exceeded our 150% objective. Likewise, UroLift brand awareness increased 60% year-over-year to 16% and has surpassed 14% per TARP, which declined 600 basis points in 2021.
至於我們的消費者營銷工作,我們繼續將直接面向消費者視為美國 UroLift 的多年催化劑。2021 年,我們超出了 DTC 活動的所有內部目標,我想分享幾個亮點.展示次數同比增長近 200%,超過了我們 150% 的目標。同樣,UroLift 的品牌知名度同比增長 60% 至 16%,並且每個 TARP 的知名度已超過 14%,到 2021 年下降了 600 個基點。
Importantly, our DTC programs are extremely focused on driving revenue for Teleflex. Since the vast majority of our customers only offer UroLift for minimally invasive treatment of BPH. We will continue to fund our DTC campaign in 2022 and retain our flexibility to flex up and down depending on the macro environment. Additionally, our international market expansion remains active with several milestones expected for 2022. In Japan, we continue to make progress towards an upcoming commercial launch for UroLift. We secured reimbursement for UroLift last December, and have a team in place to initiate our rollout launch once the reimbursement is implemented on April 1 of this year.
重要的是,我們的 DTC 計劃非常專注於為 Teleflex 增加收入。由於我們絕大多數客戶只提供 UroLift 用於 BPH 的微創治療。我們將在 2022 年繼續資助我們的 DTC 活動,並保持我們根據宏觀環境上下調整的靈活性。此外,我們的國際市場擴張依然活躍,預計到 2022 年將實現幾個里程碑。在日本,我們繼續在即將推出的 UroLift 商業發布方面取得進展。我們在去年 12 月獲得了 UroLift 的報銷,並且有一個團隊在今年 4 月 1 日實施報銷後啟動我們的推出。
Japan remains an important long-term opportunity for UroLift with a $2 billion TAM, and we are excited for the 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.
日本仍然是 UroLift 的重要長期機會,擁有 20 億美元的 TAM,我們對即將推出的產品感到興奮。我們繼續預計我們在該地區的銷售額將以與美國類似的方式增長,而市場規模僅為美國的 1/3。
Now turning to Brazil. We are encouraged by our initial commercial activity with a focus on training surgeons and securing reimbursement in the coming years. Additional UroLift launches could come in the second half of 2022, including France and initial activities in Italy and Spain. Finally, we remain on track for a regulatory clearance in China in 2023.
現在轉向巴西。我們對我們最初的商業活動感到鼓舞,這些活動的重點是培訓外科醫生和確保未來幾年的報銷。其他 UroLift 發射可能會在 2022 年下半年推出,包括法國以及在意大利和西班牙的初步活動。最後,我們仍有望在 2023 年獲得中國的監管許可。
To round out the update on UroLift, President Biden signed into law, the protecting Medicare and American farmers from Sequester Cuts Act on December 10, 2021. Among a number of important items, the law increased conversion factor in the Medicare physician fee schedule by 3% for 2022 versus the final rule issued in November. For UroLift specifically, the change will translate into an incremental $100 to $150 in profitability in the office setting in 2022 as compared to the MPFS final rule.
為了完善 UroLift 的更新,拜登總統於 2021 年 12 月 10 日簽署了保護醫療保險和美國農民免受隔離削減法案的法律。在許多重要項目中,該法律將醫療保險醫生費用表中的轉換係數提高了 3 2022 年與 11 月發布的最終規則相比的百分比。具體而言,對於 UroLift,與 MPFS 最終規則相比,這一變化將轉化為 2022 年辦公室環境的盈利能力增加 100 至 150 美元。
We are encouraged by the improvement in reimbursement, and will continue to work with stakeholders to address the unintended consequence of the changes to physician fee schedule that will limit choice for Medicare recipients and move procedures to higher-cost sites of service.
我們對報銷的改善感到鼓舞,並將繼續與利益相關者合作,解決醫生收費表變更的意外後果,這將限制 Medicare 接受者的選擇,並將程序轉移到成本更高的服務地點。
Moving to some updates in our Interventional business unit. We have completed the sales force expansion, which is intended to provide additional resources for MANTA training and increase our market penetration. On the clinical front, we recently received 510(k) clearance to extend the indication for our specialty support catheters, guide extension catheters and specialty guidewires to include cross chronic total occlusion.
轉到我們介入業務部門的一些更新。我們已完成銷售人員擴充,旨在為 MANTA 培訓提供更多資源並提高我們的市場滲透率。在臨床方面,我們最近獲得了 510(k) 許可,以擴大我們的專業支持導管、引導延長導管和專業導絲的適應症,以包括交叉慢性完全閉塞。
Our FDA filing was based on successful results from a peer-reviewed perspective single-arm IDE study that enrolled 150 patients across 13 investigational centers in the United States. The study met the protocol's primary endpoint of procedural success. And achieved technical success, which is defined as successful guidewire recanalization in more than 93% of these very complicated CTO cases. We view complex PCI and especially CTO-PCI, as high-growth spaces within interventional cardiology. And our new labeled indication keeps us competitively positioned.
我們的 FDA 備案是基於同行評審的單臂 IDE 研究的成功結果,該研究在美國 13 個研究中心招募了 150 名患者。該研究達到了協議的程序成功的主要終點。並取得了技術上的成功,這被定義為在這些非常複雜的 CTO 病例中超過 93% 的導絲再通成功。我們將復雜的 PCI,尤其是 CTO-PCI 視為介入心髒病學中的高增長空間。我們新的標籤適應症使我們保持競爭優勢。
Lastly, we continue to innovate around the core MANTA platform, and initiated a limited market release of the 14 French branch depth locator during the quarter. The depth locator expands the use of the 14 French manteclosure for Impella in emergent cardiogenic shock procedures.
最後,我們繼續圍繞核心 MANTA 平台進行創新,並在本季度啟動了 14 個法國分支深度定位器的有限市場發布。深度定位器擴展了 Impella 的 14 French manteclosure 在緊急心源性休克程序中的使用。
Regarding EZPlas, we have not yet received U.S. regulatory clearance following the receipt of a completed response letter. Importantly, we do not have to collect additional clinical data, and we have clear line of sight on the additional information that FDA is requesting. We remain committed to gaining FDA clearance for this novel and innovative product and will work collaboratively with the agency. We will update the investment community when we have additional information to share.
關於 EZPlas,我們在收到完整的回复函後尚未收到美國監管機構的許可。重要的是,我們不必收集額外的臨床數據,而且我們對 FDA 要求的額外信息有清晰的認識。我們仍然致力於為這種新穎的創新產品獲得 FDA 的許可,並將與該機構合作。當我們有更多信息要分享時,我們將更新投資社區。
Now turning to our 2022 outlook. Teleflex remains well positioned to drive growth in these challenging times. Although the pandemic and its effect on the health care providers are still with us, we expect the impact to be lower in 2022 versus 2021. We believe that elective surgical procedures should improve in 2022 over 2021. We are seeing excellent progress in the ability of the global health care systems to adapt to the pandemic environment.
現在轉向我們的 2022 年展望。 Teleflex 仍然處於有利地位,可以在這些充滿挑戰的時代推動增長。儘管大流行及其對醫療保健提供者的影響仍在我們身邊,但我們預計 2022 年的影響將低於 2021 年。我們認為,擇期外科手術應在 2022 年比 2021 年有所改善。我們看到在能力方面取得了顯著進步全球衛生保健系統以適應大流行環境。
With each subsequent surge in COVID infections, hospitals continue to improve their ability to treat COVID-19 patients and perform elective surgical procedures. We also expect more people to become fully vaccinated and increasing availability of therapies to treat the virus after infection.
隨著隨後 COVID 感染的每次激增,醫院都在繼續提高治療 COVID-19 患者和進行擇期外科手術的能力。我們還期望更多的人能夠完全接種疫苗,並增加治療感染後病毒的療法的可用性。
Our range of guidance contemplates varying scenarios for the impact of COVID, which depending on the level of disruption, inform our view on the top and bottom end of our outlook. In addition, our 2022 guidance assumes a normalization in our operating expense as the impact of the pandemic wanes. We will fund our commercial organization to remain in front of our customers and maintain investment for our growth drivers.
我們的指導範圍考慮了 COVID 影響的不同情景,這取決於中斷的程度,告知我們對前景的頂端和底端的看法。此外,我們的 2022 年指南假設隨著大流行的影響減弱,我們的運營費用將正常化。我們將為我們的商業組織提供資金,以留在我們的客戶面前,並為我們的增長動力維持投資。
It is important that we manage Teleflex for long-term durable growth, and we will continue to fund our investments to keep us well positioned. That said, to the extent that COVID is more disruptive to revenues than we have assumed, we will be in a position to modulate our spending while still funding projects for long-term growth.
重要的是,我們管理 Teleflex 以實現長期持久增長,我們將繼續為我們的投資提供資金,以保持我們的優勢地位。也就是說,如果 COVID 對收入的破壞性比我們想像的更大,我們將能夠調節我們的支出,同時仍然為長期增長的項目提供資金。
Taking these elements together, we would expect to deliver underlying constant currency growth in 2022 that captures our prior 2019 to 2021 LRP growth algorithm of 6% to 7% when adjusting for the 1.6% headwind from the divestiture of the respiratory assets. We have made substantial progress over the past several years in reshaping the Teleflex portfolio by investing behind growth drivers and divesting slower growth respiratory assets.
綜合這些因素,我們預計 2022 年將實現潛在的恆定貨幣增長,在針對呼吸資產剝離帶來的 1.6% 逆風進行調整時,我們之前的 2019 年至 2021 年 LRP 增長算法為 6% 至 7%。過去幾年,我們通過投資增長動力和剝離增長較慢的呼吸資產,在重塑 Teleflex 投資組合方面取得了重大進展。
As we look forward, when excluding UroLift and our other business, the remaining 3/4 of our business is positioned to grow 4% to 5%. The growth is propelled by a base of medically necessary products and our high-growth portfolio of products, including MANTA, Hemostats, Intraosseous and PICC. On top of these revenues, UroLift remains a significant opportunity as pandemic-related disruptions recede in the United States, and we execute on our multiyear multi-geography overseas expansion. We will also continue to execute on our M&A strategy to layer in additional growth drivers.
正如我們所期待的那樣,在排除 UroLift 和我們的其他業務後,我們其餘 3/4 的業務有望增長 4% 至 5%。這一增長是由一系列醫療必需產品和我們高增長的產品組合推動的,包括 MANTA 、止血劑、骨內和 PICC 。除了這些收入之外,隨著與流行病相關的干擾在美國消退,UroLift 仍然是一個重要的機會,我們正在執行我們多年的多地域海外擴張。我們還將繼續執行我們的併購戰略,以增加更多的增長動力。
That completes my prepared remarks. Now I'd like to turn the call over to Tom for a more detailed review of our fourth quarter financial results. Tom?
我準備好的發言到此結束。現在我想把電話轉給湯姆,讓他更詳細地審查我們第四季度的財務業績。湯姆?
Thomas E. Powell - Executive VP & CFO
Thomas E. Powell - Executive VP & CFO
Thanks, Liam, and good morning. Given the previous discussion of the company's revenue performance, I'll begin with margins. Gross and operating margins remained strong in the fourth quarter and exceeded levels achieved in the 2020 comparable period. Our continued progress in margin expansion in 2021 has allowed us to increase investments toward growth drivers, which is an important component of our long-term strategy to enhance durable growth.
謝謝,利亞姆,早上好。鑑於之前對公司收入表現的討論,我將從利潤率開始。第四季度的毛利率和營業利潤率依然強勁,超過了 2020 年同期的水平。我們在 2021 年利潤率擴張方面的持續進展使我們能夠增加對增長動力的投資,這是我們促進持久增長的長期戰略的重要組成部分。
For the quarter, adjusted gross margin totaled 58.8%, an 80 basis point increase versus the prior year period. The year-over-year increase in gross margin was driven by product and regional mix, restructuring benefits, operational efficiency programs, favorable impacts from pricing, M&A and foreign exchange, partly offset by inflation in freight, raw materials and labor.
本季度,調整後的毛利率總計為 58.8%,比去年同期增長 80 個基點。毛利率的同比增長受到產品和區域組合、重組收益、運營效率計劃、定價、併購和外彙的有利影響的推動,部分被運費、原材料和勞動力的通脹所抵消。
Fourth quarter adjusted operating margin was 27.6% or a 100 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 and a partial normalization of expenses following deep reductions in discretionary spending during the prior year as a result of the COVID pandemics.
第四季度調整後的營業利潤率為 27.6% 或同比增長 100 個基點,這得益於毛利率的改善和嚴格的費用管理,部分被計劃的業務投資和深度改革後費用的部分正常化所抵消由於 COVID 大流行,上一年的可自由支配支出減少。
Net interest expense totaled $11.8 million in the fourth quarter, a decrease from $18.5 million in the prior year period. The year-over-year decrease in net interest reflects savings from the early redemption of the 2026 senior notes and the impact of reductions of outstanding debt using the proceeds of the respiratory divestiture and operating cash flows.
第四季度淨利息支出總計 1180 萬美元,低於去年同期的 1850 萬美元。淨利息的同比下降反映了提前贖回 2026 年優先票據帶來的節省,以及使用呼吸剝離和經營現金流的收益減少未償債務的影響。
Our adjusted tax rate for the fourth quarter of 2021 was 13.8% compared to 10.1% 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 as compared to the prior year period. At the bottom line, fourth quarter adjusted earnings per share increased 10.8% to $3.60 and exceeded our internal expectations.
我們 2021 年第四季度的調整後稅率為 13.8%,而去年同期為 10.1%。我們調整後的稅率同比增長主要是由於與去年同期相比,基於股票的薪酬收益較低。最後,第四季度調整後每股收益增長 10.8% 至 3.60 美元,超出了我們的內部預期。
Turning to select balance sheet and cash flow highlights. Cash flow from operations for 2021 totaled $652.1 million compared to $437.1 million in 2020. This represents a year-over-year increase of roughly $215 million. The increase was primarily attributable to favorable operating results, lower contingent consideration payments and proceeds received from the respiratory business divestiture that were attributed to performance obligations under the manufacturing and supply transition agreement.
轉向選擇資產負債表和現金流亮點。 2021 年運營現金流總計 6.521 億美元,而 2020 年為 4.371 億美元。這意味著同比增長約 2.15 億美元。這一增長主要歸因於良好的經營業績、較低的或有對價付款以及從呼吸業務剝離中獲得的收益,這些收益歸因於製造和供應過渡協議下的履約義務。
Moving to the balance sheet. Our financial position remains sound. At the end of the fourth quarter 2021, our cash balance was $445.1 million versus $375.9 million at the end of the fourth quarter of 2020. During the fourth quarter, we repaid $200.5 million of revolving credit facility borrowings. And at the end of the fourth quarter, $141 million was outstanding on our revolver. Net leverage at quarter end was approximately 1.7x, which remains well below our 4.5x covenant. Lastly, we have no debt maturities of material size in 2022 or 2023.
轉到資產負債表。我們的財務狀況仍然穩健。 2021 年第四季度末,我們的現金餘額為 4.451 億美元,而 2020 年第四季度末為 3.759 億美元。第四季度,我們償還了 2.005 億美元的循環信貸額度借款。在第四季度末,我們的左輪手槍有 1.41 億美元未償還。季度末的淨槓桿率約為 1.7 倍,仍遠低於我們的 4.5 倍契約。最後,我們沒有在 2022 年或 2023 年到期的重大債務。
Now moving on to our 2022 guidance. To begin, I'll provide a framework of key planning assumptions underpinning our financial guidance. Although hard to predict in the current environment, our outlook for 2022 assumes that elective surgical procedures improve over 2021, but reflects COVID disruption in the first quarter. We also expect inflation to be greater in 2022 than 2021 with a larger impact in the first half of the year as compared to the second half.
現在繼續我們的 2022 年指南。首先,我將提供一個支撐我們財務指導的關鍵規劃假設框架。儘管在當前環境下很難預測,但我們對 2022 年的展望假設選擇性外科手術比 2021 年有所改善,但反映了第一季度 COVID 中斷。我們還預計 2022 年的通脹將高於 2021 年,與下半年相比,上半年的影響更大。
Our 2022 guidance ranges account for uncertainty on the severity of COVID. The impact of staffing shortage and inflationary pressures. The high end of the range assumes less impact from these factors but not a totally normal environment. In addition, our planning assumptions exclude any material regulatory or healthcare reforms as well as any future M&A that has not been disclosed.
我們的 2022 年指導範圍考慮了 COVID 嚴重性的不確定性。人員短缺和通脹壓力的影響。該範圍的高端假設這些因素的影響較小,但不是完全正常的環境。此外,我們的規劃假設不包括任何重大監管或醫療改革以及任何未披露的未來併購。
Now for the key elements of our 2022 guidance, starting with revenue. We remain confident in our portfolio of high-growth drivers and the durable growth core. We are taking a metered approach to begin the year, given expected near-term pressure from the recent COVID surge. We expect constant currency revenue growth of 4% to 5.5% in 2022. Excluding a 1.6% headwind from the sale of the respiratory assets last year, our constant currency revenue growth is expected to be 5.6% and 7.1%, and captures our prior growth algorithm in the 2019 to 2021 LRP. Our high-growth portfolio, which is spread across several business units and includes UroLift, MANTA, Hemostats, EZ-IO, OnControl and PICCs, represents approximately 25% of total revenues in 2021.
現在是我們 2022 年指南的關鍵要素,從收入開始。我們對我們的高增長驅動力和持久增長核心組合充滿信心。考慮到近期 COVID 激增帶來的預期短期壓力,我們將在今年開始時採取計量方法。我們預計 2022 年貨幣收入將保持 4% 至 5.5% 的不變增長。排除去年出售呼吸資產帶來的 1.6% 的逆風,我們的不變貨幣收入增長預計將分別為 5.6% 和 7.1%,並保持我們之前的增長2019 年至 2021 年 LRP 中的算法。我們的高增長產品組合分佈在多個業務部門,包括 UroLift、MANTA、Hemostats、EZ-IO、OnControl 和 PICC,佔 2021 年總收入的約 25%。
As implied by our 2022 constant currency revenue guidance, our high-growth portfolio is expected to increase in the mid-teens with UroLift growth of approximately 15%. Our durable core platforms, which account for over 60% of revenues are estimated to increase approximately 4%. Our other category includes sales of respiratory products not included in the divestiture to Medline. Manufacturing supply transition agreement revenues and Urology Care. It accounted for approximately 12% of total revenues in 2021. For 2022, this segment is anticipated to decline in the low to mid-teens year-over-year largely due to the respiratory divestiture.
正如我們 2022 年固定貨幣收入指引所暗示的那樣,我們的高增長投資組合預計將在 15% 左右增長,UroLift 增長約 15%。我們佔收入 60% 以上的耐用核心平台預計將增長約 4%。我們的其他類別包括呼吸產品的銷售,這些產品未包括在對 Medline 的剝離中。製造供應過渡協議收入和泌尿外科護理。它約佔 2021 年總收入的 12%。到 2022 年,預計這一細分市場將同比下降 15% 左右,這主要是由於呼吸業務剝離。
Now turning to currency. We expect foreign exchange rates will be a headwind to revenue growth of approximately 1.7%. As a result, we expect our reported revenue growth to be 2.3% to 3.8% year-over-year, implying a dollar range of $2.874 billion to $2.917 billion.
現在轉向貨幣。我們預計匯率將阻礙收入增長約 1.7%。因此,我們預計我們報告的收入同比增長 2.3% 至 3.8%,這意味著美元範圍為 28.74 億美元至 29.17 億美元。
Moving to gross margin. We anticipate that adjusted gross margin will be in a range of 59.75% to 60.25%. We continue to benefit from mix shift towards higher-margin products, restructuring and operational efficiencies, partly offset by incremental inflation. The incremental inflation is estimated to be a headwind of approximately 70 basis points in 2022, due primarily to elevated freight costs, raw materials and direct labor. Our guidance assumes that the elevated freight costs will show improvement in the second half of the year.
轉向毛利率。我們預計調整後的毛利率將在 59.75% 至 60.25% 的範圍內。我們繼續受益於向利潤率更高的產品、重組和運營效率的組合轉變,部分被增量通貨膨脹所抵消。預計到 2022 年,增量通貨膨脹將帶來大約 70 個基點的逆風,這主要是由於運費、原材料和直接勞動力的上漲。我們的指引假設運費上漲將在下半年有所改善。
Regarding operating margin, we expect adjusted operating margin to be in the range of 27.75% to 28.25%. Our 2022 guidance assumes incremental investments to support our key growth drivers, including UroLift, MANTA, intraosseous in the Asia Pacific region. In addition, as we have previously indicated, we continue to expect a normalization of operating expenses as COVID disruptions abate. Keep in mind that discretionary operating expenses, including T&E and open headcount were significantly curtailed in 2020 due to the impact of the pandemic on revenues and commercial activities. Although operating expenses increased in 2021, they were not yet fully restored to pre-COVID levels. As we plan for an improving environment in 2022, we are assuming a normalization of our operating expenses as well as investments for our growth drivers.
關於營業利潤率,我們預計調整後的營業利潤率將在 27.75% 至 28.25% 的範圍內。我們的 2022 年指南假定增加投資以支持我們的主要增長動力,包括亞太地區的 UroLift、MANTA、骨內。此外,正如我們之前指出的那樣,隨著 COVID 中斷的減少,我們繼續期望運營費用正常化。請記住,由於大流行對收入和商業活動的影響,2020 年包括 T&E 和開放員工在內的可自由支配的運營費用大幅減少。儘管 2021 年運營費用有所增加,但尚未完全恢復到 COVID 之前的水平。當我們計劃在 2022 年改善環境時,我們假設我們的運營費用和增長動力投資正常化。
Despite the disruptions over the past 2 years, we continue to make considerable progress on our margin expansion initiatives. Of note, a comparison of the midpoint of the 2022 guidance versus the 2019 pre-pandemic levels, reveals a healthy 190 basis point increase in gross margin and a 220 basis point increase in operating margin. We believe our incremental investment is prudent to fuel our long-term durable growth initiatives, especially as we see the disruption from the current COVID surge improving over time.
儘管過去 2 年出現中斷,但我們繼續在利潤擴張計劃方面取得長足進展。值得注意的是,將 2022 年指引的中點與 2019 年大流行前水平進行比較,顯示毛利率健康增長 190 個基點,營業利潤率增長 220 個基點。我們相信,我們的增量投資對於推動我們的長期持久增長計劃是謹慎的,尤其是當我們看到當前 COVID 激增帶來的破壞隨著時間的推移而改善時。
In turn, we view 2022 as a transition year for margins as it remain multiple levers to drive profitability higher over the coming years, including product mix shift, manufacturing efficiencies and announced restructurings, partially offset by continued investments in the business to sustain our durable growth profile.
反過來,我們將 2022 年視為利潤率的過渡年,因為在未來幾年它仍然有多種槓桿來提高盈利能力,包括產品組合轉變、製造效率和宣布的重組,部分抵消了對業務的持續投資以維持我們的持久增長輪廓。
Moving down the P&L. We expect net interest expense to be approximately $51 million. The year-over-year decrease in interest expense largely reflects reductions in debt funded by proceeds from the respiratory divestiture and strong cash flow generation.
向下移動損益表。我們預計淨利息支出約為 5100 萬美元。利息支出的同比下降主要反映了呼吸資產剝離收益和強勁現金流產生所資助的債務減少。
Turning to taxes. We project that our adjusted tax rate will be in the range of 10.5% to 12.5% for 2022. Of note, the high end of the range reflects the change to the tax deductibility of certain R&D expenses beginning 2022 under the 2017 Tax Cuts and Jobs Act. We understand there is bipartisan support for these R&D tax benefits, leading to the potential that the provisions that became law for 2022 could be reversed at some point during the year. If the law is repealed, we would anticipate that our tax rate to be towards the lower end of the guidance range.
轉向稅收。我們預計 2022 年調整後的稅率將在 10.5% 至 12.5% 的範圍內。值得注意的是,該範圍的上限反映了根據 2017 年減稅和就業計劃,從 2022 年開始某些研發費用的稅收減免發生變化行為。我們了解到,兩黨都支持這些研發稅收優惠,這導致 2022 年成為法律的規定有可能在年內的某個時候被撤銷。如果法律被廢除,我們預計我們的稅率將接近指導範圍的下限。
Considering these elements, our adjusted earnings per share guidance for 2022 is $13.70 to $14.30, a 2.8% to 7.3% year-over-year increase. Inclusive in the guidance is an approximately $0.17 headwind associated with the divested respiratory business and approximately $0.33 for incremental inflation. Earnings per share growth, excluding the respiratory divestiture and incremental inflation is expected to be approximately 7% to 11%. As a reminder, the low end of our adjusted EPS growth range reflects the change in the R&D expense deductibility for tax purposes.
考慮到這些因素,我們調整後的 2022 年每股收益指引為 13.70 美元至 14.30 美元,同比增長 2.8% 至 7.3%。指導意見中包括與剝離呼吸業務相關的約 0.17 美元逆風和增量通貨膨脹約 0.33 美元。每股收益增長,不包括呼吸剝離和增量通貨膨脹,預計約為 7% 至 11%。提醒一下,我們調整後的每股收益增長范圍的低端反映了出於稅收目的的研發費用扣除的變化。
We estimate that weighted average shares outstanding will increase to 47.7 million for the full year 2022.
我們估計 2022 年全年加權平均流通股數將增至 4770 萬股。
Lastly, I want to provide some additional color on the cadence of our 2022 financial results. Specifically, 3 items impacting our first quarter results. First, as I mentioned previously, our first quarter results are expected to be impacted by continued COVID-related headwinds on elective surgical procedures, similar to what many medical device companies are experiencing to date. Second, note that the first quarter has 1 less selling day as compared to the same period of 2021.
最後,我想為我們 2022 年財務業績的節奏提供一些額外的色彩。具體來說,有 3 個項目影響了我們第一季度的業績。首先,正如我之前提到的,我們第一季度的業績預計將受到與 COVID 相關的擇期手術方面持續不利因素的影響,這與許多醫療設備公司迄今為止所經歷的情況類似。其次,請注意,與 2021 年同期相比,第一季度的銷售日減少了 1 個。
Third, we expect the headwind from foreign exchange rates to be higher in the first and second quarters before moderating in the second half of 2022. Accordingly, we expect our reported revenue to be approximately flat year-over-year in the first quarter. On a days adjusted constant currency basis, our first quarter growth is expected to be approximately 3% to 3.5%. And when excluding the impact of the rest of respiratory divestiture, our days adjusted constant currency growth is expected to be roughly 5.5% to 6% in the first quarter. We also expect our adjusted gross and operating margin to decline year-over-year in the first quarter driven by incremental inflation and a normalization of operating expenses.
第三,我們預計第一季度和第二季度匯率帶來的不利影響會更大,然後在 2022 年下半年有所緩和。因此,我們預計第一季度報告的收入將與去年同期大致持平。按天數調整後的固定匯率計算,我們第一季度的增長率預計約為 3% 至 3.5%。如果排除其餘呼吸資產剝離的影響,我們預計第一季度調整後的恆定貨幣增長率約為 5.5% 至 6%。我們還預計,在通脹上升和運營費用正常化的推動下,我們調整後的毛利率和營業利潤率將在第一季度同比下降。
That concludes my prepared remarks. I would now like to turn it back to Liam for closing commentary. Liam?
我準備好的發言到此結束。我現在想把它轉回利亞姆結束評論。利亞姆?
Liam J. Kelly - Chairman, President & CEO
Liam J. Kelly - Chairman, President & CEO
Thanks, Tom. In closing, I will highlight our 3 key takeaways from the quarter and our 2022 outlook. First, our diversified product portfolio enables Teleflex to deliver constant currency growth of 7.9% in the fourth quarter and 8.8% for 2021 despite the significant disruption from COVID during the year.
謝謝,湯姆。最後,我將重點介紹本季度的 3 個關鍵要點和我們的 2022 年展望。首先,我們多元化的產品組合使 Teleflex 能夠在第四季度實現 7.9% 的穩定貨幣增長,並在 2021 年實現 8.8% 的持續增長,儘管年內受到 COVID 的嚴重干擾。
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 remain confident in our growth strategy. We see our core growth platforms driving 4% to 5% growth with the additional growth coming from UroLift as pandemic headwinds subside.
其次,我們繼續執行我們的戰略,通過投資於有機增長機會、利潤擴張和併購資本部署,推動我們多元化投資組合的持久增長。第三,我們對我們的增長戰略充滿信心。我們看到我們的核心增長平台推動了 4% 至 5% 的增長,隨著大流行的逆風消退, UroLift 帶來了額外的增長。
We have levers in place to drive further expansion in our margins. And our balance sheet is in a solid position with leverage of 1.7x, providing ample financial flexibility for our capital allocation priorities. We remain confident in our future and our ability to continue to meet our 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.
我們有適當的槓桿來推動我們的利潤率進一步擴大。我們的資產負債表處於穩固的狀態,槓桿率為 1.7 倍,為我們的資本配置優先事項提供了充足的財務靈活性。我們對我們的未來以及我們繼續履行對患者、臨床醫生、社區和股東的承諾的能力充滿信心。我準備好的發言到此結束。現在我想把電話轉回接線員進行問答。
Operator
Operator
(Operator Instructions) And your first question comes from Jayson Bedford with Raymond James.
(操作員說明)您的第一個問題來自 Jayson Bedford 和 Raymond James。
Jayson Tyler Bedford - Senior Medical Supplies and Devices Analyst
Jayson Tyler Bedford - Senior Medical Supplies and Devices Analyst
So I guess just to start, and I hate to be too granular here. But maybe can you comment on what you're seeing in the environment today versus, let's call it, a month ago? And I just want to feel a little comforted that you are seeing a little bit of a pickup as COVID wanes.
所以我想只是開始,我不想在這裡過於細化。但也許你能評論一下你今天在環境中看到的情況與一個月前相比嗎?隨著 COVID 的消退,您看到了一點回升,我只是想感到些許安慰。
Liam J. Kelly - Chairman, President & CEO
Liam J. Kelly - Chairman, President & CEO
Yes. So right across our business, Jayson, obviously, we have winners and losers every time there's a COVID outbreak. So parts of our business do better, part of the them do worse. Vascular, obviously, in some of our respiratory filters do better. Our elective procedures, UroLift being the first one and then Surgical and Interventional tend to do worse.
是的。因此,在我們的業務中,Jayson,顯然,每次 COVID 爆發時,我們都有贏家和輸家。所以我們的部分業務做得更好,部分業務做得更差。血管,顯然,在我們的一些呼吸過濾器中做得更好。我們的選擇性手術,UroLift 是第一個,然後是外科手術和介入手術,效果往往更差。
What we saw as we came through the end of August and the last outbreak, we saw, in particular, UroLift procedures pick up September, October, November. And then we saw them being impacted in December, and that continued into January. We would expect then to see an improvement as hospitals reopen and as people feel more confident in going in and having these procedures done. So we would anticipate the environment improving in the month of February and in the month of March.
我們在 8 月底和上次爆發時看到的情況是,我們特別看到 UroLift 手術在 9 月、10 月和 11 月有所增加。然後我們看到他們在 12 月受到影響,這種情況一直持續到 1 月。隨著醫院重新開放,以及人們對進入並完成這些程序更有信心,我們預計屆時情況會有所改善。因此,我們預計 2 月份和 3 月份的環境會有所改善。
And again, I've got to commend hospitals and docs offices and ASCs. They are managing the additional outbreaks much better. The issue with Omnicron was it was a lot more contagious. So it actually added to the staffing shortage with individuals having to isolate for 5 days once they were exposed to just because of the infectious nature of it. But yes, an improving environment in -- as we went through February, Jayson, to answer your question directly.
再一次,我必須讚揚醫院、文檔辦公室和 ASC。他們正在更好地管理額外的爆發。 Omnicron 的問題在於它的傳染性要強得多。因此,它實際上加劇了人員短缺,個人一旦接觸就必須隔離 5 天,僅僅因為它具有傳染性。但是,是的,在我們經歷了 2 月份的時候,傑森直接回答了你的問題,這是一個不斷改善的環境。
Jayson Tyler Bedford - Senior Medical Supplies and Devices Analyst
Jayson Tyler Bedford - Senior Medical Supplies and Devices Analyst
Okay. And just as a quick big picture follow-up. Liam, you made the comment in the release around optimizing the portfolio for growth, which is consistent with past commentary. But I guess the question is, the current environment more or less conducive for your strategy? Meaning -- I'll ask another way, can you be more active in this environment?
好的。就像快速的大局跟進一樣。利亞姆,你在新聞稿中圍繞優化投資組合以實現增長發表了評論,這與過去的評論一致。但我想問題是,當前環境或多或少有利於您的戰略?意思是——我換個方式問,你能不能在這個環境裡更活躍一點?
Liam J. Kelly - Chairman, President & CEO
Liam J. Kelly - Chairman, President & CEO
Well, the one thing you need to be active, Jayson, is firepower, and we've got lot of firepower. So our leverage levels, as we said in the call, at 1.7x. So we have firepower. Let me answer it this way. I feel a lot better today than I did a year ago with regards to valuations. We always augment our portfolio. And don't forget in the last 24 months, we have acquired HPC and Z-Medica and we divested of our respiratory assets.
好吧,傑森,你需要活躍的一件事就是火力,我們有很多火力。因此,正如我們在電話會議中所說,我們的槓桿水平為 1.7 倍。所以我們有火力。讓我這樣回答。在估值方面,我今天感覺比一年前好多了。我們總是增加我們的投資組合。不要忘記,在過去的 24 個月裡,我們收購了 HPC 和 Z-Medica,並剝離了我們的呼吸資產。
We are active out there purchasing assets. I think valuation expectations have modified as the IPO market is modified. And it's not just us telling the private companies, that it's also the banking community, communicating that to them. So yes, I'm glad that we maintained our financial discipline over the last 12 months when it was pretty heavy out there. And I think it's -- we're having a lot of easier conversations with private companies now, and they see a strategic exit as very, very favorable compared to an IPO at this stage.
我們正在積極購買資產。我認為估值預期隨著 IPO 市場的改變而改變。不僅僅是我們告訴私營公司,銀行界也在向他們傳達這一點。所以,是的,我很高興我們在過去 12 個月裡保持了財務紀律,當時那裡的情況非常沉重。而且我認為這是 - 我們現在與私營公司進行了很多更輕鬆的對話,他們認為與現階段的首次公開募股相比,戰略退出非常非常有利。
Operator
Operator
Your next question is from Lawrence Biegelsen with Wells Fargo.
你的下一個問題來自富國銀行的 Lawrence Biegelsen。
Lawrence H. Biegelsen - Senior Medical Device Equity Research Analyst
Lawrence H. Biegelsen - Senior Medical Device Equity Research Analyst
Congrats on a nice end to the year here. Liam, starting with UroLift, what are you seeing from the recent reimbursement change? And big picture, the contribution to growth there. You talked about, I think, from 4% to 5%, your lift bridging to your long-term goal, I think, of 6% to 7%. How much growth -- where do you see that additional growth coming from? How much is from international markets? And what are the other drivers? And I had 1 follow-up.
祝賀你在這裡度過了美好的一年。利亞姆,從 UroLift 開始,您從最近的報銷變化中看到了什麼?總體而言,對那裡增長的貢獻。你談到,我認為,從 4% 到 5%,你的提升橋接了你的長期目標,我認為,6% 到 7%。有多少增長——你認為額外的增長來自哪裡?有多少來自國際市場?其他驅動因素是什麼?我有 1 次跟進。
Liam J. Kelly - Chairman, President & CEO
Liam J. Kelly - Chairman, President & CEO
Yes, Larry. So with UroLift, first of all, we're really pleased with the strong finish to the year, $93 million in the fourth quarter. And indeed, our overall performance in the year, and thank you for acknowledging it. I think we're really proud of what we did. We delivered revenue growth of 8.8% versus our original guidance of 8% to 9.5%. And don't forget, the original guide of $28 million to $32 million of respiratory revenue that we divested, delivered gross margins 59.4%, 270 basis points of expansion, up margin 310 basis points of expansion. And earnings per share, 25% growth in earnings per share, while also losing $0.10 to $0.15 in the respiratory divestiture.
是的,拉里。因此,對於 UroLift,首先,我們對今年的強勁表現感到非常滿意,第四季度為 9300 萬美元。事實上,我們今年的整體表現,感謝您的認可。我認為我們真的為我們所做的感到自豪。我們實現了 8.8% 的收入增長,而我們最初的指導是 8% 至 9.5%。別忘了,我們剝離的 2800 萬至 3200 萬美元呼吸收入的原始指南實現了 59.4% 的毛利率,擴張了 270 個基點,擴張了 310 個基點。而每股收益,每股收益增長 25%,同時在呼吸業務剝離中也損失了 0.10 美元至 0.15 美元。
Looking forward, we've obviously communicated that we expect UroLift to grow 15% this year. We feel that, that's very achievable in the current environment. We expect it's going to be impacted by COVID in the first quarter as one would anticipate. And then we would anticipate lower single digits in the first half of the year and then picking up strongly in the back half of the year, obviously, an easier comp in Q3. And then going into Q4, as people work through their deductibles, you'd expect it to continue along that vein.
展望未來,我們顯然已經傳達了我們預計 UroLift 今年將增長 15%。我們認為,在當前環境下,這是非常可以實現的。我們預計它會像人們預期的那樣在第一季度受到 COVID 的影響。然後我們預計上半年會出現較低的個位數,然後在下半年強勁回升,顯然,第三季度的比較容易。然後進入第四季度,隨著人們計算他們的免賠額,你會希望它繼續沿著這條路走下去。
We're really confident on our core business being well capable of 4% to 5%, Larry. And with good execution, I think we should be at the upper end of that range. So our growth algorithm of 6% to 7% is very, very much intact, as demonstrated in our guide today. So our constant currency guide is 4% to 5.5%. But there's 1.6% of a headwind from the respiratory divestiture, that's 30 basis points from the loss of a day, which is in Q1, which actually gets you to 5.9% to 7.4%.
拉里,我們對我們的核心業務能夠很好地達到 4% 到 5% 非常有信心。如果執行得當,我認為我們應該處於該範圍的上限。所以我們的 6% 到 7% 的增長算法非常非常完整,正如我們今天的指南中所展示的那樣。所以我們的固定匯率指導是 4% 到 5.5%。但是呼吸剝離帶來了 1.6% 的逆風,這是第一季度損失一天的 30 個基點,實際上讓你達到 5.9% 到 7.4%。
So if anything, the algorithm has improved because of the base, our core business doing even better through good execution and really solid investment behind some of our good growth assets such as Intraosseous, such as our PICC portfolio, such as MANTA and such as our hemostasis portfolio.
因此,如果有的話,由於基礎,算法得到了改進,我們的核心業務通過良好的執行和真正穩固的投資在我們一些良好的增長資產(例如 Intraosseous)背後做得更好,例如我們的 PICC 投資組合,例如 MANTA 和我們的止血組合。
Lawrence H. Biegelsen - Senior Medical Device Equity Research Analyst
Lawrence H. Biegelsen - Senior Medical Device Equity Research Analyst
That's helpful. And for my follow-up, Liam, just to follow up on Jayson's question earlier on M&A. What are your criteria deal size? How are you thinking about deal size? And any areas of interest you can share?
這很有幫助。對於我的後續行動,利亞姆,只是為了跟進傑森早些時候關於併購的問題。您的標準交易規模是多少?您如何考慮交易規模?您可以分享任何感興趣的領域嗎?
Liam J. Kelly - Chairman, President & CEO
Liam J. Kelly - Chairman, President & CEO
Absolutely, Larry. So we look at assets that are in that $600 million to -- $60 million to $300 million in revenue. Our strategic criteria is that it fits within one of our pillars or in an adjacent space. It's got a really strong IP. Has a great value proposition within the hospital. Also has -- is clinically better than anything within the marketplace available. And we like products that are sticky.
當然,拉里。因此,我們看看收入在 6 億至 6000 萬至 3 億美元之間的資產。我們的戰略標準是它適合我們的支柱之一或相鄰空間。它有一個非常強大的IP。在醫院內具有很大的價值主張。也有 - 在臨床上比市場上可用的任何東西都要好。我們喜歡有粘性的產品。
They get used over and over again. We obviously look for assets that are accretive to our gross margin. And we look for assets that are -- will become accretive to our op margin in time. We'll accept some shorter-term op margin dilution like we did, for example, with NeoTract as long as we can see leverage into the future. So those are really our financial and strategic criteria, Larry, and thanks for the questions.
他們一遍又一遍地使用。我們顯然在尋找能夠增加我們毛利率的資產。我們尋找的資產——將及時增加我們的運營利潤率。我們將接受一些短期的運營利潤稀釋,就像我們所做的那樣,例如,只要我們能看到未來的槓桿作用,就使用 NeoTract。所以這些確實是我們的財務和戰略標準,拉里,感謝您提出問題。
Operator
Operator
Your next question is from Matt Taylor with UBS.
你的下一個問題來自瑞銀的馬特泰勒。
Matthew Charles Taylor - Equity Research Analyst of Medical Supplies & Devices
Matthew Charles Taylor - Equity Research Analyst of Medical Supplies & Devices
I just wanted to ask specifically on UroLift, the 15% guidance. Two things. One, could you help us a little bit more with the cadence of UroLift growth that you expect through the year? And how much contribution from Japan are you anticipating?
我只是想具體詢問 UroLift,即 15% 的指導。兩件事情。第一,你能否幫助我們了解你全年預期的 UroLift 增長節奏?您期待日本做出多少貢獻?
Liam J. Kelly - Chairman, President & CEO
Liam J. Kelly - Chairman, President & CEO
Yes. Good question, Matt. So as I answered Larry, the first half will grow in the lower single digits due to the impact of COVID-19 through the first quarter and obviously, staffing shortages, while the second half of the year will grow really strong double digits. The contributions will be small from the international markets. You've got Japan, Brazil and France. They'll ramp in the second half of the year, but they won't really become meaningful math until 2023 and beyond.
是的。好問題,馬特。因此,正如我回答拉里的那樣,由於第一季度 COVID-19 的影響以及顯然人員短缺,上半年將以較低的個位數增長,而下半年將以兩位數的速度增長。來自國際市場的貢獻將很小。你有日本、巴西和法國。它們將在今年下半年增加,但要到 2023 年及以後才能真正成為有意義的數學。
So for this year, 2022, the main growth driver for UroLift will continue to be the United States. And I'll just add to that, Matt, and I mentioned this in my prepared remarks that we trained through the pandemic. That is the most best tactical way to drive growth in UroLift in 2022 and then bring on the international markets in '23 and beyond. And obviously, you'll see places like China come into being in '23. So we feel that we've got a real great algorithm for growth for all of Teleflex, but also from -- for UroLift.
因此,到今年,即 2022 年,UroLift 的主要增長動力仍將是美國。我還要補充一點,馬特,我在準備好的發言中提到了這一點,我們通過大流行病進行了培訓。這是在 2022 年推動 UroLift 增長然後在 23 年及以後進入國際市場的最佳戰術方式。顯然,你會看到像中國這樣的地方在 23 世紀出現。因此,我們覺得我們已經為所有 Teleflex 以及 UroLift 的增長提供了一個真正偉大的算法。
And as Tom outlined in his prepared remarks, we've got 25% of our total revenue that is in that mid-teens growth, which includes Europe, but as well as that, you've got MANTA and Hemostat, and intraosseous and PICC, all driving that real solid top line growth for Teleflex.
正如湯姆在他準備好的發言中概述的那樣,我們的總收入的 25% 是在十幾歲中期的增長,其中包括歐洲,但除此之外,你還有 MANTA 和 Hemostat,以及骨內和 PICC ,所有這些都推動了 Teleflex 真正穩固的收入增長。
Matthew Charles Taylor - Equity Research Analyst of Medical Supplies & Devices
Matthew Charles Taylor - Equity Research Analyst of Medical Supplies & Devices
Great. And just a follow-up on the pipeline. Did you give an update on the RFP? Or could you give us an update on that, where that is?
偉大的。並且只是對管道的跟進。您是否更新了 RFP?或者你能告訴我們最新情況嗎?它在哪裡?
Liam J. Kelly - Chairman, President & CEO
Liam J. Kelly - Chairman, President & CEO
Yes. I did in the prepared remarks, Matt. So as I said in the prepared remarks, we've received the CRL, and we are working on the information requested. The good news is the request from the FDA is not focused on clinical data and with clear line of sight on the additional information that the FDA is requesting. We will continue to interface with the FDA, and it is very collaborative.
是的。我在準備好的發言中做了,馬特。因此,正如我在準備好的評論中所說,我們已經收到 CRL,我們正在處理所要求的信息。好消息是 FDA 的要求並不側重於臨床數據,並且明確關注 FDA 要求的其他信息。我們將繼續與 FDA 接觸,這是非常合作的。
But it's clear to us, Matt, this is also the first time the FDA has approved a biologic products such as this. So we're breaking new ground together. And as you're aware, Matt, and as most investors will be aware, the RFP from the military within that $3 million to $4 million, it's a nice market in the future, it's $100 million that we'll grow into. But that $3 million to $4 million is not in our guidance for this year.
但我們很清楚,馬特,這也是 FDA 首次批准此類生物製品。所以我們正在一起開闢新天地。正如你所知,馬特,正如大多數投資者所知,來自軍方的 RFP 在 300 萬至 400 萬美元之間,這是未來一個不錯的市場,我們將成長為 1 億美元。但這 300 萬到 400 萬美元不在我們今年的指導中。
Operator
Operator
Your next question is from Shagun Singh with RBC Capital Markets.
你的下一個問題來自 RBC 資本市場的 Shagun Singh。
Shagun Singh Chadha - Research Analyst
Shagun Singh Chadha - Research Analyst
I was just wondering if you could just let us know what the impact is of inflation and FX on margins and EPS in Q4. And then what have you assumed in 2022? And then just with respect to margins, can you bridge us from '21 to '22? I'm just trying to understand the puts and takes. So as it relates to, I guess, UroLift 2.0 conversion, we have slightly less than 40 basis points inflation. I think you called out 70 basis points on the call, annual pretax savings. I think you have about $40 million in '22 and '23 in. And then just higher level of investments. If you can just bridge that, that would be helpful.
我只是想知道您是否可以讓我們知道通貨膨脹和外匯對第四季度利潤率和每股收益的影響。那麼您在 2022 年假設了什麼?然後就利潤率而言,您能否將我們從 21 世紀過渡到 22 世紀?我只是想了解 puts 和 takes。因此,我猜,與 UroLift 2.0 轉換有關,我們的通貨膨脹率略低於 40 個基點。我想你在電話會議上提出了 70 個基點,年度稅前節省。我認為你在 22 年和 23 年有大約 4000 萬美元。然後是更高水平的投資。如果你能彌補這一點,那將是有幫助的。
Liam J. Kelly - Chairman, President & CEO
Liam J. Kelly - Chairman, President & CEO
Thank you, Shagun. That level of detail requires somebody called Thomas Powell. So Tom?
謝謝你,沙根。這種程度的細節需要一個叫托馬斯鮑威爾的人。那麼湯姆?
Thomas E. Powell - Executive VP & CFO
Thomas E. Powell - Executive VP & CFO
Okay. So I think the first question was just on the impact of inflation or FX in inflation in the fourth quarter. So as we look at the fourth quarter, I'll start with FX first. What we saw was a bit of a move in the exchange rates. And some of the tailwind that we had been experiencing through the earlier part of the year lessened quite a bit. So it was an adverse impact on our margins relative to the prior year, but still slightly positive on a year-over-year basis.
好的。所以我認為第一個問題只是關於通貨膨脹或外匯對第四季度通貨膨脹的影響。因此,當我們看第四季度時,我將首先從 FX 開始。我們看到的是匯率的一點變動。我們在今年早些時候經歷的一些順風已經減弱了很多。因此,與上一年相比,這對我們的利潤率產生了不利影響,但與去年同期相比仍略有積極影響。
As far as inflation, we had talked about inflation ticking up in the fourth quarter relative to what we were seeing in the third quarter, and we had estimated the amount to be approximately $3 million. It actually turned out to be higher, close to $4.5 million in the fourth quarter. And we've obviously assumed that, that's going to continue to be some of the case going into next year. As we think about just margins as we go into next year, there are a number of puts and takes.
至於通貨膨脹,我們已經談到第四季度的通貨膨脹率相對於我們在第三季度看到的情況有所上升,我們估計數額約為 300 萬美元。實際上結果更高,第四季度接近 450 萬美元。而且我們顯然已經假設,這種情況將繼續成為明年的一些情況。當我們進入明年時只考慮利潤率時,有很多看跌期權。
First of all, I'd say that the gross margin, I'd like to remind everyone that it had increased 270 basis points in 2021 versus 2020. So really strong expansion in 2021 despite a higher inflationary environment. As we look to 2022, our guidance is 59.75% to 60.25%, representing an increase of 60 basis points at the midpoint. The gross margin increase, as mentioned, attributable to mix, mostly UroLift as well as restructuring and operational efficiency programs being partly offset by inflation.
首先,我想說毛利率,我想提醒大家,2021 年毛利率比 2020 年增加了 270 個基點。儘管通脹環境較高,但 2021 年的擴張非常強勁。展望 2022 年,我們的指引為 59.75% 至 60.25%,中點增加 60 個基點。如前所述,毛利率的增長歸因於混合,主要是 UroLift 以及重組和運營效率計劃被通貨膨脹部分抵消。
And for 2022, our guidance assumes that supply chain inflation is approximately $20 million higher than the 2021 inflation level, and that equates to an incremental inflation impact of about 70 basis points. So if you were to look at our guide on gross margin, excluding the impact of that incremental inflation, we're up about 130 basis points at the midpoint. And as we think about the cadence of gross margin, we do expect to see a strengthening gross margin as we go throughout 2022. Right now, our guidance assumes -- or included in our guidance is an assumption that we will see some improvement in raw material and logistics inflation in the second half of the year versus the levels we're currently expecting.
對於 2022 年,我們的指導假設供應鏈通脹比 2021 年的通脹水平高出約 2000 萬美元,這相當於約 70 個基點的增量通脹影響。因此,如果您查看我們的毛利率指南,排除增量通貨膨脹的影響,我們在中點上漲了約 130 個基點。當我們考慮毛利率的節奏時,我們確實希望在整個 2022 年看到毛利率有所提高。目前,我們的指導假設——或包含在我們的指導中的假設是,我們將看到原始收入有所改善今年下半年的材料和物流通脹與我們目前預期的水平相比。
And we also expect to get a mix benefit as we go throughout the year as UroLift becomes a greater percentage of the mix and actually the manufacturing supply agreement becomes a lesser part of the mix. So I would say big picture, gross margin is impacted by inflation and the cadence of quarterly margin expansion impacted by both inflation levels as well as mix.
我們還希望在全年中獲得混合收益,因為 UroLift 在混合中所佔比例更大,而實際上製造供應協議在混合中所佔比例較小。所以我想說大局,毛利率受到通貨膨脹的影響,季度利潤率擴張的節奏受到通貨膨脹水平和組合的影響。
Now as we look at the operating margin, we are guiding to 27.75% to 30.25%, which is flat to 2021 at the midpoint. A couple of things, again, to highlight, first of all, is that increase in the supply chain inflation has an adverse impact to gross margin, and that drops down to the operating margin.
現在,當我們查看營業利潤率時,我們將其指導為 27.75% 至 30.25%,與 2021 年的中點持平。有幾件事,首先要強調的是,供應鏈通貨膨脹的增加對毛利率有不利影響,並且會下降到營業利潤率。
And then secondly, I do want to highlight that in 2020, we had significantly reduced OpEx spending as a result of the COVID pandemic, in part because the pandemic caused limitations on our commercial activities. But also in part because we wanted to reduce cost to offset the COVID revenue impacts. Now in 2021, we partially restored activities in spending, but we weren't back to pre-pandemic levels of activity or spend.
其次,我想強調的是,在 2020 年,由於 COVID 大流行,我們大幅減少了運營支出,部分原因是大流行對我們的商業活動造成了限制。但也部分是因為我們希望降低成本以抵消 COVID 收入的影響。現在到了 2021 年,我們部分恢復了支出活動,但我們並沒有回到大流行前的活動或支出水平。
In 2022, our guidance assumes that we will largely resume normal commercial activities, including hiring, sales, training, meetings, et cetera. And as a result, we'll incur an incremental about $20 million or 70 basis points of OpEx in the year.
到 2022 年,我們的指導假設我們將在很大程度上恢復正常的商業活動,包括招聘、銷售、培訓、會議等。因此,我們今年將增加約 2000 萬美元或 70 個基點的 OpEx。
So if you look at the op margin, excluding the impacts of the supply chain inflation and normalization of expenses, we'd see about a 140 basis point improvement at the midpoint. Now in addition, in 2022, we plan to continue to invest behind key growth franchises, including UroLift, MANTA and EZ-IO. I'd say that given the successes we've seen in the UroLift DTC as well as sales force additions, we'll continue to invest there as well as behind MANTA. And then again, we will see some op margin improvement as the year progresses for a lot of the same reasons that we're talking about in the gross margin improvement. Hopefully, I answered all your questions.
因此,如果你看一下營業利潤率,排除供應鏈通脹和費用正常化的影響,我們會看到中點改善約 140 個基點。現在,此外,到 2022 年,我們計劃繼續投資於主要增長特許經營權,包括 UroLift、MANTA 和 EZ-IO。我想說,鑑於我們在 UroLift DTC 中看到的成功以及銷售人員的增加,我們將繼續在那里以及 MANTA 背後進行投資。然後,由於我們在毛利率改善中談論的許多相同原因,隨著時間的推移,我們將再次看到運營利潤率有所改善。希望我回答了你所有的問題。
Shagun Singh Chadha - Research Analyst
Shagun Singh Chadha - Research Analyst
Yes, appreciate it.
是的,很感激。
Operator
Operator
Your next question is from Cecilia Furlong with Morgan Stanley.
你的下一個問題來自摩根士丹利的 Cecilia Furlong。
Cecilia E. Furlong - Equity Analyst
Cecilia E. Furlong - Equity Analyst
I wanted to start back on UroLift. Just -- you talked about initiatives to drive UroLift utilization in your existing position base. As well as drive adoption in newly trained positions. Can you walk through some of the kind of key points that you're focused on this year? And then kind of a bigger longer-term picture. But as you get out of COVID, as you think about all of the international markets coming online, Japan, China, Brazil, Europe as well, how do you think about just the durable long-term growth profile of UroLift?
我想重新開始使用 UroLift。剛剛——您談到了在現有職位基礎上推動 UroLift 利用率的舉措。以及推動新培訓職位的採用。您能否介紹一下您今年關注的一些關鍵點?然後是更大的長期圖景。但是當你擺脫 COVID 時,當你想到所有國際市場上線時,日本、中國、巴西、歐洲以及你如何看待 UroLift 持久的長期增長狀況?
Liam J. Kelly - Chairman, President & CEO
Liam J. Kelly - Chairman, President & CEO
So I think once we get -- what's very clear to me to the latter part of your question, Cecilia, is that UroLift growth is impacted by COVID. We've seen this at every outbreak of COVID. And as I just said a few minutes earlier, we saw UroLift pick up in September through November quite substantially.
所以我認為,一旦我們得到——塞西莉亞,你的問題的後半部分我很清楚,UroLift 的增長受到 COVID 的影響。我們在每次 COVID 爆發時都看到了這一點。正如我幾分鐘前所說的那樣,我們看到 UroLift 在 9 月到 11 月期間大幅回升。
And then obviously, in December, we saw it take a step back because of the outbreak of COVID. Notwithstanding that, we still exceeded our internal expectations because of the robustness of the growth in the first 2 months of the quarter. And the reason, Cecilia, that we're focused on a few pillars of growth for UroLift.
然後很明顯,在 12 月,由於 COVID 的爆發,我們看到它後退了一步。儘管如此,由於本季度前兩個月的強勁增長,我們仍然超出了我們的內部預期。塞西莉亞,我們專注於 UroLift 增長的幾個支柱的原因。
The first pillar of growth is going to be around driving utilization in existing docks over the next number of years. What we've seen during COVID is our champions and our interventionists. And remember, these are people that almost predominantly to a very, very high percent only offer UroLift. And because of reluctance in patients, because of staffing shortages, we've seen their utilization drop a little bit through the COVID environment.
增長的第一個支柱將是在未來幾年內推動現有碼頭的利用率。我們在 COVID 期間看到的是我們的擁護者和乾預者。請記住,這些人幾乎主要是非常非常高的百分比只提供 UroLift。由於患者的不情願,由於人員短缺,我們看到他們的利用率在 COVID 環境中略有下降。
So the easiest way to get UroLift back in to drive that 15% growth is drive utilization there. The second point is, for the future is to continue to do that but also to expand overseas. And you'll see Japan coming in beginning in April 1. You'll see France in the back half of the year. You'll see Brazil continue to move as we go through the year. You'll see China come in next year. Maybe then somewhere like Taiwan, you'll see -- pardon me, Italy and Spain come along.
因此,讓 UroLift 重新回到推動 15% 增長的最簡單方法是提高那裡的利用率。第二點,未來就是要繼續做那個,還要往海外擴張。你會看到日本從 4 月 1 日開始。你會在下半年看到法國。隨著我們度過這一年,您會看到巴西繼續前進。明年你會看到中國進來。也許然後在台灣這樣的地方,你會看到——對不起,意大利和西班牙也會出現。
So most companies would expect the revenues they do in the U.S., if you execute well overseas, you should do almost the same amount of revenue overseas over a multiyear period. And then lastly is obviously bringing on new docs. We continue to train new docs as we go through the year. And I think that it's important for everybody to realize we haven't penetrated this market by any stretch of the imagination. We've only trained about 3,400 docs out of 12,000.
所以大多數公司會期望他們在美國的收入,如果你在海外執行得好,你應該在多年內在海外獲得幾乎相同數量的收入。然後 last 顯然帶來了新的文檔。在這一年中,我們將繼續培訓新文檔。而且我認為重要的是每個人都應該意識到我們還沒有通過任何想像進入這個市場。我們只培訓了 12,000 名文檔中的大約 3,400 名文檔。
And we've only done 300,000 procedures, almost all of them in the United States out of 12 million men in the United States and 100 million globally. So the opportunities for growth over a multiyear period, I feel really encouraged by, and we just want to get COVID in the rearview mirror, and then really show what this product can do from a growth profile.
我們只做了 300,000 例手術,幾乎所有手術都發生在美國,美國有 1200 萬男性,全球有 1 億人。因此,在多年期間的增長機會,我感到非常鼓舞,我們只想在後視鏡中看到 COVID,然後真正展示該產品可以從增長情況中做什麼。
Lawrence Soren Keusch - VP of IR & Strategy Development
Lawrence Soren Keusch - VP of IR & Strategy Development
And Cecilia, it's Larry. I would just mention that we will obviously provide a longer-term view of our outlook for UroLift at our May Analyst Meeting.
塞西莉亞,是拉里。我只想提一下,我們顯然會在 5 月份的分析師會議上提供對 UroLift 前景的長期看法。
Operator
Operator
Your next question is from Mike Matson with Needham & Company.
您的下一個問題來自 Needham & Company 的 Mike Matson。
Michael Stephen Matson - Senior Analyst
Michael Stephen Matson - Senior Analyst
I wanted to ask about the UroLift reimbursement changes that happened. I think that went into effect at the beginning of the year. So can you maybe talk about what you're seeing there? Have you seen maybe the physicians changing site of care or anything else? And with the 15% guidance, how much have you factored in, if anything, for that issue?
我想詢問發生的 UroLift 報銷變更。我認為那是在今年年初生效的。那麼你能談談你在那裡看到了什麼嗎?你有沒有看到醫生改變護理地點或其他任何東西?在 15% 的指導下,您為該問題考慮了多少(如果有的話)?
Liam J. Kelly - Chairman, President & CEO
Liam J. Kelly - Chairman, President & CEO
So we haven't seen any site of service change, and I don't anticipate seeing any site of service change in the coming year. The law that was signed in by President Biden actually improved the reimbursement for the UroLift in the office procedure by changing the conversion factor by about 3%. That actually added another $100 to $150 net to the urologist for doing this procedure. We've also implemented our own pricing strategy in the marketplace, and that has been incredibly well received.
所以我們沒有看到任何服務站點發生變化,我預計來年也不會看到任何服務站點發生變化。拜登總統簽署的法律實際上通過將換算係數更改約 3%,改善了辦公室程序中 UroLift 的報銷。這實際上為泌尿科醫生增加了 100 到 150 美元的淨額來執行此程序。我們還在市場上實施了自己的定價策略,並且受到了難以置信的好評。
Only 6 weeks into it, a very high percentage of our customers have signed up to our plan. So I would envision a very -- I wouldn't envision much of the shift inside of service. And Mike, don't forget as well, 70% of our UroLift cases are done outside of the office. And the CMS ruling only impacted Medicare Medicaid patients in the office, which, if you do the math, is about 20% of the total. So we have strategies in place. The team is executing, and the 15% growth is predicated on everything that we know today and our knowledge of what's going to happen with COVID we move forward throughout the year.
僅僅 6 週後,我們就有很高比例的客戶簽署了我們的計劃。所以我會設想一個非常 - 我不會設想服務內部的大部分轉變。邁克,也不要忘記,我們 70% 的 UroLift 病例都是在辦公室外完成的。 CMS 的裁決只影響辦公室裡的 Medicare Medicaid 患者,如果你算一下,這大約佔總數的 20%。所以我們有適當的策略。團隊正在執行,15% 的增長是基於我們今天所知道的一切,以及我們對 COVID 將要發生的事情的了解,我們全年都在前進。
Michael Stephen Matson - Senior Analyst
Michael Stephen Matson - Senior Analyst
Okay. And if I could just slip one in for Tom quickly. Is there any kind of EPS impact from currency? I did hear that called out and you kind of walked through the headwinds. But just given that it is meaningful to the top line, I wanted to see if it was getting kind of offset on the bottom line.
好的。如果我能快點給 Tom 塞一個進去就好了。貨幣對 EPS 有什麼影響嗎?我確實聽到了那聲呼喊,你有點逆風而行。但鑑於它對頂線有意義,我想看看它是否在底線上得到了某種抵消。
Thomas E. Powell - Executive VP & CFO
Thomas E. Powell - Executive VP & CFO
So the currency impact that we've assumed in our guidance is about $0.20.
因此,我們在指南中假設的貨幣影響約為 0.20 美元。
Operator
Operator
Your next question is from Matthew Mishan with KeyBanc.
你的下一個問題來自 KeyBanc 的 Matthew Mishan。
Matthew Ian Mishan - VP & Senior Equity Research Analyst
Matthew Ian Mishan - VP & Senior Equity Research Analyst
Just the first question on Vascular Access. That continues to exceed our expectations, and it's about $100 million above where you were at in 2019. It seems like you're pretty confident around PICC and Vidacare as you're kind of moving those into the high-growth category. I'm just curious, how should we think about the durability of the improvement in Vascular Access versus maybe some of the other areas that may have been COVID-related beneficiaries?
只是關於血管通路的第一個問題。這繼續超出我們的預期,比你在 2019 年的水平高出約 1 億美元。你似乎對 PICC 和 Vidacare 非常有信心,因為你正在將它們轉移到高增長類別。我只是好奇,我們應該如何考慮血管通路改善的持久性與可能與 COVID 相關的受益者的其他一些領域?
Liam J. Kelly - Chairman, President & CEO
Liam J. Kelly - Chairman, President & CEO
Yes. So for Vascular Access, this year, we expect it to grow in the mid-single digits in its entirety. Obviously, our CVC portfolio benefited from COVID over the last couple of years. But the growth is really coming from our intraosseous portfolio and also from our PICC portfolio as we continue to take share because of our coating technology. This is really a global play for us.
是的。因此,對於 Vascular Access,今年我們預計它會以中等個位數的速度增長。顯然,我們的 CVC 投資組合在過去幾年中受益於 COVID。但增長實際上來自我們的骨內產品組合,也來自我們的 PICC 產品組合,因為我們的塗層技術繼續佔據市場份額。這對我們來說真的是一場全球性的比賽。
We've launched a really nice new CBC kit that is getting excellent traction out there in the market globally, and that's also helping uptrade our customers on our CBCs in our key -- globally, but in our key North American market for sure. So we feel really good. It's our largest franchise, Matt.
我們已經推出了一個非常好的新 CBC 工具包,它在全球市場上獲得了極大的吸引力,這也有助於我們的客戶在我們的主要市場上使用我們的 CBCs 進行升級交易——全球,但肯定是在我們的主要北美市場。所以我們感覺非常好。這是我們最大的特許經營權,馬特。
It continues to execute incredibly well. We have a new -- as well as that new product, we have another new product that's coming around our PICC, positioning in our PICC that we're very excited about. And so this is one of the -- we've often said not all growth is equal. This is one of the businesses that gets more R&D dollars spent than others. And keeps that flow and new products come to keep ourselves differentiated, and it's a great franchise.
它繼續執行得非常好。我們有一個新的 - 以及那個新產品,我們還有另一個新產品圍繞我們的 PICC 推出,定位在我們的 PICC 中,我們對此感到非常興奮。所以這是其中之一 - 我們經常說並非所有增長都是平等的。這是比其他企業花費更多研發資金的企業之一。並保持這種流動和新產品來保持我們的差異化,這是一個很好的特許經營權。
Matthew Ian Mishan - VP & Senior Equity Research Analyst
Matthew Ian Mishan - VP & Senior Equity Research Analyst
Okay. Excellent. And then just an update -- and I'm sorry if I missed it, on where Z-Medica ended for 2021. And thoughts on growth drivers for that product into next year.
好的。出色的。然後只是一個更新——如果我錯過了,我很抱歉,關於 Z-Medica 在 2021 年結束的地方。以及對該產品到明年的增長動力的想法。
Liam J. Kelly - Chairman, President & CEO
Liam J. Kelly - Chairman, President & CEO
Yes. We're really happy with where Z-Medica finished. We told the investment community to be somewhere between $60 million to $70 million. We finished squarely in there $66.5 million. Really proud of the achievements, bringing that into Teleflex. And nothing is changed in our outlook. That's well capable of high single, good execution, low double-digit growth and really accretive to our margins, again, another growth driver. And that's in the bucket that Tom spoke about, that's driving an average in the mid-teens. And of course, we have a cardiac study that we just completed, we will file with the FDA. And that will expand the $600 million TAM also, Matt. So really excited about it.
是的。我們對 Z-Medica 的結局感到非常滿意。我們告訴投資界要在 6000 萬到 7000 萬美元之間。我們在那裡完成了 6650 萬美元。真正為取得的成就感到自豪,並將其帶入 Teleflex。我們的前景沒有任何改變。這很好地實現了高單一、良好的執行、低兩位數的增長,並且真正增加了我們的利潤率,這又是另一個增長動力。這就是湯姆所說的桶,這推動了十幾歲的平均水平。當然,我們剛剛完成了一項心臟研究,我們將向 FDA 提交申請。這也將擴大 6 億美元的 TAM,馬特。真的很興奮。
Operator
Operator
And your last question comes from David Turkaly with JMP Securities.
你的最後一個問題來自 JMP Securities 的 David Turkaly。
David Louis Turkaly - MD & Equity Research Analyst
David Louis Turkaly - MD & Equity Research Analyst
Maybe just a couple of quick product one to follow up on that. The PICC side, would you notice anything on the competitive front, there was a bigger player there that grew for years at the rate that you seem to be now. Has anything changed there? Or would you actually point to the differentiated coatings as sort of how you're maintaining that?
也許只是幾個快速產品來跟進。在 PICC 方面,你會注意到競爭方面的任何事情嗎,那裡有一個更大的參與者,多年來以你現在看起來的速度增長。那裡有什麼變化嗎?或者您實際上會指出差異化塗層作為您維護它的方式嗎?
Liam J. Kelly - Chairman, President & CEO
Liam J. Kelly - Chairman, President & CEO
So for us, it's all about the coatings. And what changed, Dave, was in the past, hospitals didn't have to report infections on PICCs. And the assumption was when they weren't measuring it, the assumption was that the PICC infections were lower. PICC infections on CBC is used to be at 4% before we launched our coated technology on the CBCs. And with -- many studies have shown we've been able to bring it down to practically 0. And of course, once they started measuring PICC infections, they were around 4%. So now hospitals don't get reimbursed for those infections. And that's why we're being so successful with our PICC technologies. It's really around our coatings that are both antithrombogenic and anti-infectious.
所以對我們來說,一切都與塗層有關。戴夫,過去發生的變化是,醫院不必報告 PICC 上的感染情況。假設是當他們不測量它時,假設 PICC 感染率較低。在我們在 CBC 上推出塗層技術之前,CBC 上的 PICC 感染率通常為 4%。而且 - 許多研究表明我們已經能夠將其降低到幾乎為 0。當然,一旦他們開始測量 PICC 感染,他們大約是 4%。所以現在醫院不會因這些感染而得到報銷。這就是我們的 PICC 技術如此成功的原因。它真正圍繞著我們的抗血栓形成和抗感染塗層。
David Louis Turkaly - MD & Equity Research Analyst
David Louis Turkaly - MD & Equity Research Analyst
And maybe just a follow up. An area we don't talk about a lot, but on surgical, you mentioned instruments and ligation clips. But 16%, even if there's procedure bounce-back, seems high. I guess what is happening there? What is differentiated there? Or how are you able to put up numbers like that in an area that I would think would be a much lower growth opportunity?
也許只是跟進。一個我們談論不多的領域,但在外科手術方面,你提到了器械和結紮夾。但 16%,即使有程序反彈,似乎也很高。我猜那裡發生了什麼?那裡有什麼區別?或者你如何能夠在我認為增長機會低得多的領域提出這樣的數字?
Liam J. Kelly - Chairman, President & CEO
Liam J. Kelly - Chairman, President & CEO
Yes. Also within -- this is also a global play for our Surgical business. So we have a really strong Surgical business in the Americas and in APAC. And as procedures bounced so did our Surgical portfolio. But we're also working on expanded indications for our coal ligation clips that should help us continue to augment the growth. Now it's not going to grow at that clip for next year, and I don't want to mislead anybody that is going to do that.
是的。同樣在 - 這也是我們外科業務的全球業務。因此,我們在美洲和亞太地區擁有非常強大的外科業務。隨著程序的反彈,我們的外科產品組合也出現了反彈。但我們也在努力擴大我們的煤結紮夾的適應症,這應該有助於我們繼續增加增長。現在它明年不會以這種速度增長,我不想誤導任何打算這樣做的人。
It will be in the low single digits as we go through next year. But we are -- we have some new products coming down the -- this year -- sorry, I said next year, this year, 2022, it will grow in the low single digits. But we have some nice pipeline of products coming through there, and we've expanded our vascular closure. We've really like working on our instruments.
明年我們將經歷低個位數。但是我們 - 今年我們有一些新產品 - 抱歉,我說明年,今年,2022 年,它將以較低的個位數增長。但是我們有一些很好的產品管道通過那裡,我們已經擴大了我們的血管閉合。我們真的很喜歡在我們的樂器上工作。
And of course, it holds like as we continue to perform exceptionally well globally. And quite frankly, the team in Surgical has done an outstanding job in executing as procedures have returned. And also an area that we take price, I should mention that. It's a nice opportunity for us. And on pricing I think it's important that we did mention, we anticipate having positive pricing this year on that 50 basis points consistent what we drove last year in order to offset some of the inflationary pressures. And it's for a company by Teleflex, I believe that will be successful because we're used to taking prices out of our DNA, and we'll continue to execute on that price, in particular, with Surgical within our Vascular business unit and also overseas in Asia and Europe. So I just want to make a point as well before we close.
當然,隨著我們在全球範圍內繼續表現出色,它仍然存在。坦率地說,隨著程序的恢復,Surgical 團隊在執行方面做得非常出色。還有一個我們採取價格的領域,我應該提到這一點。這對我們來說是一個很好的機會。在定價方面,我認為我們提到的這一點很重要,我們預計今年的定價將與我們去年推動的 50 個基點保持一致,以抵消一些通脹壓力。這是 Teleflex 旗下的一家公司,我相信這會成功,因為我們習慣於從我們的 DNA 中剔除價格,我們將繼續按照這個價格執行,特別是在我們的血管業務部門內的 Surgical 以及在亞洲和歐洲的海外。所以我只想在我們結束之前說明一點。
Operator
Operator
That is currently all the time we have for questions this morning. I will now turn the call back to Mr. Keusch for closing remarks.
這是我們今天早上所有的提問時間。我現在將把電話轉回給 Keusch 先生作結束語。
Lawrence Soren Keusch - VP of IR & Strategy Development
Lawrence Soren Keusch - VP of IR & Strategy Development
Thank you, April, and thank you to everyone that joined us on the call today. This concludes the Teleflex Incorporated Fourth Quarter 2021 Earnings Conference Call.
謝謝你,April,也感謝今天加入我們電話會議的每一個人。泰利福公司 2021 年第四季度收益電話會議到此結束。
Operator
Operator
This does conclude our conference for today. Thank you for your participation. You may now disconnect.
這確實結束了我們今天的會議。感謝您的參與。您現在可以斷開連接。