使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Good morning, and welcome to Bausch + Lomb's first quarter 2025 earnings call. All participants will be in listen-only mode. (Operator Instructions) Please note, this event is being recorded.
早安,歡迎參加博士倫 2025 年第一季財報電話會議。所有參與者將處於只聽模式。(操作員指示)請注意,此事件正在被記錄。
I would now like to turn the conference over to George Gadkowski, Vice President of Investor Relations and Business Insights. Please go ahead.
現在,我想將會議交給投資者關係和商業洞察副總裁 George Gadkowski。請繼續。
George Gadkowski - Vice President, Investor Relations & Business Insights
George Gadkowski - Vice President, Investor Relations & Business Insights
Thank you. Good morning, everyone, and welcome to our first quarter 2025 financial results conference call. Participating on today's call are Chairman and Chief Executive Officer, Mr. Brent Saunders; and Chief Financial Officer, Mr. Sam Eldessouky. In addition to this live webcast, a copy of today's slide presentation and a replay of this conference call will be available on our website under the Investor Relations section.
謝謝。大家早安,歡迎參加我們 2025 年第一季財務業績電話會議。參加今天電話會議的有董事長兼執行長布倫特桑德斯先生;和財務長 Sam Eldessouky 先生。除了本次網路直播外,我們網站的「投資者關係」部分還將提供今天的幻燈片簡報副本和本次電話會議的重播。
Before we begin, I would like to remind you that our presentation today contains forward-looking information. We would ask that you take a moment to read the forward-looking legend at the beginning of our presentation as it contains important information.
在我們開始之前,我想提醒您,我們今天的演示包含前瞻性資訊。我們希望您花一點時間閱讀我們簡報開頭的前瞻性圖例,因為它包含重要資訊。
This presentation contains non-GAAP financial measures and ratios. For more information about these measures and ratios, please refer to slide 1 of the presentation. Non-GAAP reconciliations can be found in the appendix to the presentation posted on our website.
本簡報包含非公認會計準則財務指標和比率。有關這些措施和比率的更多信息,請參閱簡報的第 1 張幻燈片。非公認會計準則對帳表可在我們網站上發布的簡報附錄中找到。
The financial guidance in this presentation is effective as of today only. It is our policy to generally not update guidance until the following quarter unless required by law and not to update or affirm guidance other than through broadly disseminated public disclosure.
本簡報中的財務指導僅自今日起有效。我們的政策是,除非法律要求,否則一般不會在下個季度之前更新指導,除非透過廣泛傳播的公開披露,否則不會更新或確認指導。
With that, it's my pleasure to turn the call over to Brent.
說完這些,我很高興將電話轉給布倫特。
Brent Saunders - Chairman of the Board, Chief Executive Officer
Brent Saunders - Chairman of the Board, Chief Executive Officer
Thank you, George, and good morning, everyone. I'm going to put our first quarter performance in context and provide updates on two timely topics, followed by Sam's focus on the financials, including 2025 guidance. I'll wrap things up with examples of growth and opportunity in each of our businesses that have us excited for what the future holds.
謝謝你,喬治,大家早安。我將介紹我們第一季的業績,並提供兩個及時主題的最新信息,然後 Sam 將重點介紹財務狀況,包括 2025 年的指導。我將以我們每項業務中令我們對未來充滿期待的成長和機會的例子來總結。
Almost two years ago, on my first earnings call after returning as CEO, I outlined our plan to reestablish Bausch + Lomb as the best eye health company. Core to that strategy are the priorities shown here, which have become a mainstay of earnings presentations and part of our DNA internally.
大約兩年前,在我重返執行長職位後的第一次財報電話會議上,我概述了我們將博士倫重塑為最佳眼保健公司的計劃。該策略的核心是這裡顯示的優先事項,它們已成為收益報告的主要內容和我們內部 DNA 的一部分。
Establishing our priorities was critical, but our ability to stay the course will ultimately determine our success. We had a few bumps in the road to start the year, but our core business is performing well, and we remain focused on positioning the company for long-term profitable growth. We delivered mid-single-digit constant currency revenue growth in the first quarter, which we expect will be in line with industry growth.
確定我們的優先事項至關重要,但我們堅持下去的能力最終將決定我們的成功。今年伊始,我們遇到了一些困難,但我們的核心業務表現良好,我們仍然專注於讓公司長期獲利成長。我們在第一季實現了中等個位數的恆定貨幣收入成長,我們預計這將與行業成長保持一致。
While we did see constant currency revenue growth across all three reporting segments, Pharmaceuticals took a step back for two reasons: underperformance in our high-margin US Generics business and Xiidra revenue headwinds, which we previously communicated despite impressive TRx growth. Both are being addressed, which we'll get into later.
雖然我們確實看到所有三個報告部門的貨幣收入都在持續增長,但製藥業務卻出現了倒退,原因有二:我們高利潤的美國仿製藥業務表現不佳,以及 Xiidra 收入面臨逆風,儘管 TRx 增長令人印象深刻,但我們之前已經傳達過這些逆風。這兩個問題都正在解決中,我們稍後會討論。
Instead of using our sales and operations update to top market share growth or the latest advances in manufacturing, I'd like to highlight the resiliency of my colleagues around the world. The voluntary recall of IOLs on our enVista platform and the evolving tariff landscape presented new challenges, and I couldn't be more impressed with the response.
我不想用我們的銷售和營運更新來衡量市場份額的成長或製造業的最新進步,而是想強調世界各地同事的韌性。我們 enVista 平台上 IOL 的自願召回以及不斷變化的資費格局帶來了新的挑戰,而我對此的回應印象深刻。
Grittiness, accountability and customer-first mentality continue to define our team. When it comes to innovation, enthusiasm around our pipeline is at an all-time high. We have big things around the corner with the potential to significantly enhance the standard of care in eye health.
堅韌、責任感和客戶至上的心態繼續定義我們的團隊。談到創新,我們管道周圍的熱情達到了前所未有的高度。我們即將取得重大進展,有可能大幅提高眼保健水準。
I'll preface our recall update with a simple message, patient safety is non-negotiable. That's why we didn't wait for additional data or regulatory action when a toxic anterior segment syndrome, or TASS signal was detected in certain intraocular lenses on our enVista platform. We voluntarily pulled the lenses from the market in late March because it was the right thing to do.
在我們的召回更新之前,我想說一句簡單的話:病人安全是不容談判的。這就是為什麼當我們的 enVista 平台上的某些人工水晶體中檢測到毒性前段症候群或 TASS 訊號時,我們沒有等待額外的數據或監管行動。我們在三月底主動將該鏡片從市場上撤下,因為這是正確的做法。
Our ability to return to market approximately one month later is nothing short of remarkable and speaks to the power of our people I referenced earlier. We immediately began a thorough investigation in collaboration with globally recognized TASS expert and an advisory group of nearly 30 top cataract surgeons, including leadership from the American Society of Cataract and Refractive Surgery.
我們能夠在大約一個月後重返市場,這真是了不起,也證明了我之前提到的員工的力量。我們立即與全球公認的 TASS 專家以及由近 30 名頂級白內障外科醫生組成的顧問小組(其中包括美國白內障和屈光手術協會的領導)合作,展開了徹底的調查。
All signs began to point to lots that used raw material from a different vendor, which allowed us to confirm the cause. Inspection protocols for IOLs have been enhanced, and we've established more explicit standards for vendors. With these new processes in place, we've returned to full production of all enVista IOLs.
所有跡像都表明該批次產品使用了來自不同供應商的原材料,這使我們能夠確認原因。我們加強了對 IOL 的檢查協議,並為供應商制定了更明確的標準。隨著這些新流程的實施,我們已恢復所有 enVista IOL 的全面生產。
Replenishing the US market is underway, with timing for market re-entry in other countries being handled on a case-by-case basis in collaboration with health authorities. The amount of positive feedback and encouragement from customers over the past month has been overwhelming. Our relationships with the eye care professionals are built on trust, and I am confident our actions and transparency are helping to strengthen those bonds.
美國市場的補貨工作正在進行中,其他國家市場的重新進入時間將與衛生當局逐案合作處理。過去一個月來,來自客戶的正面回饋和鼓勵非常多。我們與眼科護理專業人士的關係建立在信任的基礎上,我相信我們的行動和透明度有助於加強這種連結。
One of the benefits of being in business for more than 170 years is significant experience in dealing with uncertainty. We've weathered many storms as a resilient business in a resilient industry. That's important in the current tariff environment, which we are approaching with level heads and confidence in our planning. Sam will quantify the potential impact on our business, which is, of course, a moving target.
擁有 170 多年商業經驗的優勢之一就是在處理不確定性方面擁有豐富的經驗。作為一家在富有韌性的行業中具有韌性的企業,我們已經度過了許多風暴。這在當前的關稅環境下非常重要,我們正以冷靜的頭腦和對規劃的信心來應對這一情況。薩姆將量化對我們業務的潛在影響,當然,這是一個不斷變化的目標。
As things currently stand, our biggest exposure is exporting from the US to China, given the escalation of reciprocal tariffs. That said, there are several levers we can pull that we believe will mitigate the overall impact of tariffs. These include inventory stocking, moving more manufacturing in-house and reevaluating pricing where and when it makes sense. But our biggest asset is our global footprint, which we began optimizing well before tariffs were on anyone's radar.
就目前情況而言,鑑於互惠關稅的升級,我們最大的風險敞口是從美國出口到中國。儘管如此,我們相信可以採取一些措施來減輕關稅的整體影響。這些措施包括庫存備貨、將更多製造業務轉移到內部以及在合理時間和地點重新評估價格。但我們最大的資產是我們的全球影響力,早在關稅引起人們關注之前,我們就開始對其進行優化。
Our manufacturing presence spans the globe and is matched by an expansive network of contract manufacturers and distribution facilities. When the dust settles, whenever that may be, we have the ability to shift many elements of our manufacturing based on cost effectiveness. In addition to blunting potential tariff impacts, this flexibility allows us to play offense against competitors with footprints that may not be as advantageous.
我們的製造業務遍布全球,並擁有龐大的合約製造商和分銷設施網絡。當一切塵埃落定之後,無論何時,我們都有能力根據成本效益來調整製造的許多要素。除了減輕潛在的關稅影響之外,這種靈活性還使我們能夠對那些可能不那麼有利的競爭對手發動攻擊。
Production of Daily SiHy contact lenses, our fastest-growing product, is a prime example. Those lenses are made in two places: Rochester, New York and Waterford, Ireland, which could significantly lessen our exposure. While any shift in manufacturing would take time, scenario planning is well underway.
我們成長最快的產品 Daily SiHy 隱形眼鏡的生產就是一個典型的例子。這些鏡片是在兩個地方製造的:紐約州羅徹斯特和愛爾蘭沃特福德,這可以大大減少我們所受到的輻射。儘管製造業的任何轉變都需要時間,但情境規劃正在順利進行中。
Q1 financial highlights include constant currency revenue growth across all reporting segments, once again, demonstrating our holistic strength and lack of reliance on one product or region. 5% constant currency revenue growth in Vision Care was fueled by another quarter of dramatic Daily SiHy uptake and the Blink franchise establishing itself as a fast-growing brand in the OTC dry eye space. Stalwarts like Lumify and Artelac continue to outperform and build lasting brand equity.
第一季的財務亮點包括所有報告部門的貨幣收入持續成長,這再次證明了我們的整體實力以及對單一產品或地區的依賴。視力保健業務收入以 5% 的固定匯率增長,這得益於 Daily SiHy 又一個季度的大幅增長以及 Blink 特許經營權在 OTC 乾眼症領域成為快速增長的品牌。Lumify 和 Artelac 等巨頭繼續表現出色,並建立持久的品牌資產。
Premium IOLs helped to drive 11% constant currency revenue growth in surgical, which points to the ongoing opportunity and significance of getting enVista lenses back on the market safely and quickly. It's important to remember that our premium IOL portfolio is more than just enVista. In fact, we expect to introduce the full range of Vision LuxLife IOLs in Europe by the end of the second quarter.
高端 IOL 協助推動外科手術收入以固定匯率計算成長 11%,這表明 enVista 鏡片安全、快速地重返市場具有持續的機會和重要性。重要的是要記住,我們的優質 IOL 產品組合不僅僅是 enVista。事實上,我們預計第二季末在歐洲推出全系列 Vision LuxLife IOL。
Earlier, I referenced headwinds in Pharmaceuticals where Q1 performance can best be described as a mixed bag despite 1% constant currency revenue growth. US generics faced increased competition and lower inventory within the channel, and Xiidra gross to net adjustments came in as expected. On the flip side, Miebo, once again, hit the high end of our projections, and International Pharma posted another solid quarter.
之前,我提到了製藥業面臨的阻力,儘管固定匯率營收成長了 1%,但第一季的業績表現可謂好壞參半。美國仿製藥面臨通路內競爭加劇和庫存減少的問題,Xiidra 的毛利與淨利調整符合預期。另一方面,Miebo 再次達到了我們預測的高端,而 International Pharma 又公佈了一個穩健的季度業績。
I'll now turn it over to Sam, who will go deeper on the financials and provide 2025 guidance.
現在我將把主題交給 Sam,他將深入探討財務狀況並提供 2025 年的指導。
Sam Eldessouky - Chief Financial Officer, Executive Vice President
Sam Eldessouky - Chief Financial Officer, Executive Vice President
Thank you, Brent, and good morning, everyone. Before we begin, please note that all of my comments today will be focused on growth expressed on constant currency basis unless specifically indicated otherwise.
謝謝你,布倫特,大家早安。在我們開始之前,請注意,除非另有明確說明,否則我今天的所有評論都將集中在以固定貨幣基礎表示的成長。
Turning now to our financial results on slide 9. Total company revenue for the quarter was $1.137 billion, which reflects growth of 5%. As Brent mentioned, we are maintaining our focus on executing our strategy, and our core business is performing well.
現在就來看看投影片 9 上的財務結果。本季公司總營收為 11.37 億美元,成長 5%。正如布倫特所說,我們正專注於執行我們的策略,我們的核心業務表現良好。
In the quarter, Miebo continued its exceptional launch performance, and we saw ongoing growth momentum in our consumer and contact lens businesses. Our Surgical segment delivered solid growth across all three product categories, and we're excited to return the enVista IOLs to the market. For the first quarter, currency was a headwind of approximately $19 million to revenue and $7 million to adjusted EBITDA.
本季度,Miebo 延續了其卓越的發布表現,並且我們的消費者和隱形眼鏡業務也繼續保持成長勢頭。我們的外科部門在所有三個產品類別中都實現了穩健的成長,我們很高興 enVista IOL 重返市場。第一季度,貨幣因素對收入造成約 1,900 萬美元的不利影響,對調整後 EBITDA 造成約 700 萬美元的不利影響。
Now, let's discuss the results in each of our segments in more detail. Vision Care first quarter revenue of $656 million increased by 5%, driven by growth in both consumer and contact lenses. The consumer business grew by 5% in Q1.
現在,讓我們更詳細地討論每個部分的結果。視力保健第一季營收為 6.56 億美元,成長 5%,主要得益於消費者眼鏡和隱形眼鏡業務的成長。第一季消費者業務成長了5%。
Let me go over a few highlights. In the quarter, Lumify grew by 9%. Lumify continues to expand its market leading position. We continued our strong execution in the dry eye portfolio, which delivered $92 million of revenue in Q1, representing 15% growth. Our two key franchises, Artelac and Blink, once again contributed to the strong performance. Artelac grew by 15% and Blink grew by 85% in the quarter. Eye Vitamins grew by 4% in the quarter, driven by consumer consumption trends.
讓我來回顧一下其中的幾個亮點。本季度,Lumify 成長了 9%。Lumify 繼續擴大其市場領先地位。我們繼續在乾眼症產品組合中保持強勁表現,該組合在第一季實現了 9,200 萬美元的收入,成長了 15%。我們的兩個主要特許經營權 Artelac 和 Blink 再次為強勁的業績做出了貢獻。本季度,Artelac 成長了 15%,Blink 成長了 85%。受消費者消費趨勢的推動,眼部維生素本季成長了 4%。
Contact lens revenue growth was 5%. In the quarter, we saw solid growth in both the Daily and FRP portfolios. The Daily portfolio was up 7%. The growth was led by our Daily SiHy franchise, which was up 42% in the quarter. The FRP portfolio grew by 5%, led by our Ultra franchise, which was up 15% in the quarter. In Q1, we saw growth in both the US and international markets. The US was up 7% and international was up 4%. Our contact lens business in China performed well and was up 6% in the quarter.
隱形眼鏡收入成長5%。本季度,我們看到每日和 FRP 投資組合均實現了穩健成長。每日投資組合上漲了7%。這一成長主要得益於我們的 Daily SiHy 特許經營權,該業務在本季度增長了 42%。FRP 投資組合成長了 5%,其中 Ultra 特許經營權成長最快,本季成長了 15%。第一季度,我們看到美國和國際市場均實現了成長。美國上漲 7%,國際上漲 4%。我們在中國的隱形眼鏡業務表現良好,本季成長了 6%。
Moving now to the Surgical segment. First quarter revenue was $214 million, an increase of 11%. In Q1, we once again saw growth in each of our three surgical product categories across the major markets. Consumables, which represents approximately 50% of Surgical revenue, grew by 5%. Revenue from equipment was up 9%, and implantables grew by 26%. Standard IOLs, which are approximately 60% of the implantables portfolio, were up 6%. Premium IOLs were up 77%, led by growth of enVista.
現在轉到外科手術部分。第一季營收為2.14億美元,成長11%。在第一季度,我們再次看到主要市場上三個外科產品類別都實現成長。耗材約佔外科手術收入的 50%,成長了 5%。設備收入成長了 9%,植入物收入成長了 26%。標準 IOL 約佔植入式人工水晶體組合的 60%,上漲了 6%。高端 IOL 銷量上漲 77%,主要得益於 enVista 的成長。
Keep in mind that Q1 sales were not impacted by the recall. Prior to the recall, we expected the enVista platform to be a meaningful contributor to our full year guidance, and it continued to perform ahead of our expectations in the first quarter. While we do expect the recall to have a one-time impact in 2025, we are excited about the platform returning to market and are confident that over time, we will see the strong growth trajectory continue.
請記住,第一季的銷售並未受到召回的影響。在召回之前,我們預計 enVista 平台將對我們的全年業績指引做出重大貢獻,並且其在第一季的表現繼續超出我們的預期。雖然我們確實預計此次召回將在 2025 年產生一次性影響,但我們對該平台重返市場感到興奮,並相信隨著時間的推移,我們將看到強勁的成長軌跡繼續下去。
Lastly, revenue in the Pharma segment was $267 million in Q1, which represents growth of 1%. Our US branded Rx business was up 7% in the quarter, led by the continued performance of Miebo. Miebo delivered $57 million of revenue in Q1. This represents sequential growth of 8% and year-over-year growth of over 100%. Our investments in Miebo continue to drive the exceptional market adoption with Miebo TRx having expanded each quarter since launch.
最後,製藥部門第一季的營收為 2.67 億美元,成長 1%。在 Miebo 持續表現的帶動下,我們的美國品牌 Rx 業務在本季成長了 7%。Miebo 第一季的營收為 5,700 萬美元。這意味著連續成長 8%,年成長超過 100%。我們對 Miebo 的投資繼續推動著卓越的市場採用,Miebo TRx 自推出以來每個季度都在擴大。
As Brent will discuss, average weekly TRx were approximately 20,000 in Q1 and have nearly doubled from the prior year. Xiidra delivered $67 million of revenue in the quarter. To start the year, the dynamics of Xiidra are playing out as we have previously discussed. We saw the natural seasonality where the first quarter is typically the lowest and the fourth quarter is the highest. We also saw strong growth in volume with average weekly TRx up 14% on a year-over-year basis.
正如布倫特將要討論的,第一季平均每週 TRx 約為 20,000,幾乎是前一年的兩倍。Xiidra 本季營收為 6,700 萬美元。新年伊始,Xiidra 的動態正如我們之前討論的那樣。我們看到了自然的季節性,其中第一季通常最低,而第四季最高。我們也看到交易量強勁成長,平均每週交易量年增 14%。
The growth in TRx was offset by higher gross to net deductions, driven by the Inflation Reduction Act and our investment to maximize patient access. We remain committed to driving Xiidra growth and believe the strategy will pay off given the long runway.
受《通貨膨脹削減法案》和我們為最大限度提高患者就醫機會而進行的投資推動,TRx 的增長被更高的總扣除額與淨扣除額所抵消。我們將繼續致力於推動 Xiidra 的發展,並相信該策略從長遠來看一定會獲得回報。
In other parts of the Pharma segment, our International Pharma business was up 6% with strong performance in our largest markets in Europe. Our US Generics business declined 23% in the quarter, driven by increased competition and lower inventory in the drug retail chain. As we look forward to the remainder of the year, we are executing multiple levers to help manage the dynamics in the generics business.
在製藥部門的其他部分,我們的國際製藥業務成長了 6%,在歐洲最大的市場表現強勁。由於競爭加劇和藥品零售鏈庫存減少,我們的美國仿製藥業務本季下降了 23%。展望今年剩餘時間,我們將採取多種措施來幫助管理仿製藥業務的動態。
Now, let me walk through some of the key non-GAAP line items on slide 10. Adjusted gross margin for the first quarter was 59.5%. This includes a one-time headwind of approximately 140 basis points related to the recall of enVista.
現在,讓我介紹一下第 10 張投影片上的一些關鍵非 GAAP 專案。第一季調整後毛利率為59.5%。其中包括與 enVista 召回相關的約 140 個基點的一次性不利因素。
In Q1, we invested $86 million in adjusted R&D. First quarter adjusted EBITDA excluding IPR&D was $126 million. This includes a one-time impact of $16 million related to inventory write-off as a result of the enVista recall. It also includes a $14 million headwind, driven by the decline of our higher-margin US Generics business. In the quarter, currency headwinds to adjusted EBITDA were approximately $7 million. Net interest expense for the quarter was $91 million and adjusted EPS, excluding IPR&D, was a loss of $0.07 for the quarter.
第一季度,我們在調整後的研發方面投資了 8,600 萬美元。第一季調整後的 EBITDA(不含 IPR&D)為 1.26 億美元。其中包括因 enVista 召回而導致的 1600 萬美元的庫存註銷一次性影響。它還包括 1400 萬美元的逆風,這是由於我們利潤率較高的美國仿製藥業務的衰退所致。本季度,調整後 EBITDA 的貨幣不利因素約為 700 萬美元。本季淨利息支出為 9,100 萬美元,不包括智慧財產權與研發的調整後每股收益為虧損 0.07 美元。
Turning now to our 2025 guidance on slide 13. As I mentioned, our core business is performing well, and we expect the performance to continue throughout the year. We are raising our full year revenue guidance to a range of $5 billion to $5.1 billion. The updated range absorbs the one-time impact of the enVista recall, offset by favorable currency impact relative to our previous guidance. We are excited to return the enVista IOLs to the market. As enVista ramps back up, for the full year 2025, we estimate one-time recall headwinds of approximately $55 million to revenue and $65 million to adjusted EBITDA.
現在轉到第 13 張投影片上的 2025 年指引。正如我所提到的,我們的核心業務表現良好,我們預計這種表現將全年持續下去。我們將全年營收預期上調至 50 億美元至 51 億美元。更新後的範圍吸收了 enVista 召回的一次性影響,並被相對於我們先前指導有利的貨幣影響所抵消。我們很高興將 enVista IOL 重新推向市場。隨著 enVista 的復甦,我們估計 2025 年全年一次性召回阻力將對收入造成約 5,500 萬美元的影響,對調整後 EBITDA 造成約 6,500 萬美元的影響。
Recently, we saw significant decline in the US dollar, which reversed our previous FX headwind assumptions. Based on current exchange rates, for the full year 2025, we now estimate currency to be neutral relative to 2024. The updated revenue guidance represents constant currency growth of approximately 4.5% to 6.5%. Excluding the one-time impact of the enVista recall, the constant currency revenue growth is expected to remain in line with our previous guidance range of 5.5% to 7.5%.
最近,我們看到美元大幅下跌,這扭轉了我們先前的外匯逆風假設。根據目前匯率,我們估計 2025 年全年貨幣相對於 2024 年將保持中性。更新後的收入預期代表約 4.5% 至 6.5% 的固定貨幣成長率。排除 enVista 召回事件的一次性影響,預計固定貨幣收入成長將與我們先前的 5.5% 至 7.5% 的指導範圍保持一致。
Shifting to adjusted EBITDA. We are updating our adjusted EBITDA guidance to a range of $850 million to $900 million. This also absorbs the one-time impact related to the enVista recall, partially offset by favorable currency impact relative to our previous guidance.
轉向調整後的 EBITDA。我們將調整後的 EBITDA 指引更新至 8.5 億美元至 9 億美元之間。這也吸收了與 enVista 召回相關的一次性影響,但部分被相對於我們先前指導的有利貨幣影響所抵消。
In terms of the other key assumptions underlying our guidance, we expect adjusted gross margin to be approximately 61.5%. The adjusted gross margin absorbs an estimated one-time 60 basis points headwind from the enVista recall.
就我們指引的其他關鍵假設而言,我們預期調整後的毛利率約為 61.5%。調整後的毛利率吸收了 enVista 召回事件造成的約 60 個基點的一次性不利影響。
For the full year, we continue to expect investments in R&D to be about 7.5% of revenue. As we monitor market conditions, we continue to expect interest expense to be approximately $375 million for the full year. We expect our adjusted tax rate to be approximately 15%, which is at the low end of our previous guidance range. The lower rate relative to our previous guidance is mainly driven by the impact of the enVista recall. We continue to expect full year CapEx to be approximately $280 million.
就全年而言,我們預計研發投資仍將佔營收的 7.5% 左右。隨著我們監測市場狀況,我們繼續預計全年利息支出約為 3.75 億美元。我們預計調整後的稅率約為 15%,這處於我們先前指導範圍的低端。與我們先前的指導相比,較低的利率主要是受到 enVista 召回的影響。我們繼續預計全年資本支出約為 2.8 億美元。
In terms of our phasing, we continue to expect a natural seasonality of our business with the first quarter being the lowest and the fourth quarter being the highest. Also, keep in mind, the impact of the enVista recall in our phasing this year. We anticipate the recall to have a more meaningful impact in Q2, which will include cost incurred as part of the investigation and a slower ramp as we return to full market supply. We anticipate enVista sales to progressively increase in Q3 and Q4 as surgeon adoption expense. Consistent with our previous guidance, our current guidance excludes any potential one-time IPR&D charges that we may incur in 2025.
就我們的分階段而言,我們繼續預計我們的業務將呈現自然的季節性,其中第一季最低,第四季度最高。另外,請記住,enVista 召回對我們今年的分階段措施的影響。我們預計此次召回將在第二季產生更重大的影響,其中包括調查過程中產生的成本以及恢復全面市場供應時產量成長放緩。我們預計,隨著外科醫生採用費用的增加,enVista 的銷售額將在第三季和第四季逐步增加。與我們先前的指導一致,我們目前的指導不包括我們在 2025 年可能產生的任何潛在的一次性 IPR&D 費用。
Finally, let me provide more detail on our perspectives regarding tariffs. As Brent mentioned, the tariff policy continues to be a moving target. We are staying focused and executing on what we can control to help mitigate the potential impact. We have already taken immediate actions to help mitigate part of the impact, and we'll continue to evaluate levers that we believe will provide us with additional benefits to further offset the potential tariff impact.
最後,讓我更詳細地闡述我們對關稅的看法。正如布倫特所提到的,關稅政策仍然是一個不斷變化的目標。我們正在集中精力並執行我們能夠控制的措施來幫助減輕潛在的影響。我們已經立即採取行動,幫助減輕部分影響,並且我們將繼續評估我們認為將為我們帶來額外利益的手段,以進一步抵消潛在的關稅影響。
Based on what we know today, we estimate tariffs to be a potential headwind of approximately 120 basis points to adjusted EBITDA margin in 2025. To be clear, this does not include all the potential mitigating levers we are currently evaluating.
根據我們目前掌握的信息,我們估計關稅將對 2025 年調整後的 EBITDA 利潤率造成約 120 個基點的潛在阻力。需要明確的是,這並不包括我們目前正在評估的所有潛在緩解手段。
Given the dynamic environment and as we continue to evaluate various mitigating levers, our updated guidance range does not reflect the potential tariff impact. We'll continue to provide you with an update as we progress throughout the year.
鑑於動態環境以及我們持續評估各種緩解手段,我們更新的指導範圍並未反映潛在的關稅影響。隨著全年的進展,我們將繼續為您提供最新資訊。
Moving to slide 14. Now, let me provide some additional color on how to think about the updated revenue and adjusted EBITDA guidance in 2025. Excluding the one-time impact of the enVista recall, we continue to expect our business to perform well throughout the remainder of 2025. Our updated 2025 revenue guidance range is $5 billion to $5.1 billion. It absorbs an estimated $55 million one-time impact of the enVista recall. The updated revenue guidance range also includes a positive currency movement of approximately $100 million relative to our previous guidance.
移至投影片 14。現在,讓我提供一些關於如何看待 2025 年更新的收入和調整後的 EBITDA 指引的額外資訊。除 enVista 召回事件的一次性影響外,我們預計我們的業務在 2025 年剩餘時間內仍將表現良好。我們更新後的 2025 年營收預測範圍為 50 億至 51 億美元。它吸收了 enVista 召回事件造成的約 5500 萬美元的一次性影響。更新後的收入指導範圍還包括相對於我們先前的指導約 1 億美元的正向貨幣變動。
Our updated 2025 adjusted EBITDA guidance range is $850 million to $900 million. It absorbs an estimated $65 million one-time impact of the enVista recall, $60 million of which we saw in the first quarter. The updated adjusted EBITDA guidance range also includes a positive currency movement of approximately $20 million relative to our previous guidance.
我們更新後的 2025 年調整後 EBITDA 指引範圍為 8.5 億美元至 9 億美元。它吸收了 enVista 召回事件約 6500 萬美元的一次性影響,其中 6000 萬美元是在第一季產生的。更新後的調整後 EBITDA 指導範圍還包括相對於我們先前的指導約 2000 萬美元的正向貨幣變動。
To sum up, we delivered mid-single-digit constant currency revenue growth in the first quarter, and our core business is performing well. We are maintaining our focus on executing our strategy and positioning the company for long-term profitable growth.
總而言之,我們在第一季實現了中等個位數的恆定貨幣收入成長,我們的核心業務表現良好。我們將繼續專注於執行我們的策略,並為公司的長期獲利成長做好準備。
And now, I'll turn the call back to Brent.
現在,我將把電話轉回給布倫特。
Brent Saunders - Chairman of the Board, Chief Executive Officer
Brent Saunders - Chairman of the Board, Chief Executive Officer
Thanks, Sam. Let's turn our attention to growth drivers for 2025 and beyond. Miebo prescriptions grew a staggering 98% year-over-year, crossing 20,000 in Q1. Perhaps more impressive was the 37% increase from Q4, which tells us we're still in launch mode with plenty of room to run. Prescribers understand the medication's unique benefits, which we're driving home with data.
謝謝,山姆。讓我們把注意力轉向2025年及以後的成長動力。Miebo 處方量年增 98%,第一季超過 20,000 份。或許更令人印象深刻的是較第四季成長了 37%,這表明我們仍處於啟動模式,並且還有很大的發展空間。開處方者了解藥物的獨特優勢,我們透過數據來證明這一點。
In February, a Phase 4 study was published showing Miebo provided relief from dry eye symptoms for nearly 50% of patients in as little as five minutes after first use, adding to an already impressive data set and addressing patient needs.
今年 2 月發布的一項第 4 階段研究表明,Miebo 在首次使用後僅五分鐘內就為近 50% 的患者緩解了乾眼症狀,進一步豐富了原本就令人印象深刻的數據集並滿足了患者的需求。
Xiidra prescriptions grew 14% year-over-year, followed steady growth throughout 2024. Both medications, which combined for $124 million in Q1 reported revenue, continue to benefit from effective direct-to-consumer campaigns and coverage that allows us to reach significantly larger patient populations. I referenced sustained power of Artelac and Lumify earlier. Let's focus on two consumer brands that fall under the Blink umbrella and the power of effective direct-to-consumer outreach.
Xiidra 處方量年增 14%,並在 2024 年全年保持穩定成長。這兩種藥物在第一季報告的收入總計 1.24 億美元,繼續受益於有效的直接面向消費者的行銷活動和覆蓋範圍,使我們能夠覆蓋到更大的患者群體。我之前提到過 Artelac 和 Lumify 的持續功率。讓我們專注於 Blink 旗下的兩個消費品牌以及有效的直接面向消費者的推廣力量。
Last year, in the US, we launched Blink NutriTears, a clinically-proven OTC nutritional supplement for dry eyes. Uptake can be slow with any new offering, especially in a space typically reserved for eye drops, but the latest figures are very encouraging and build on momentum we shared last quarter.
去年,我們在美國推出了 Blink NutriTears,這是一款經過臨床驗證的治療乾眼症的非處方營養補充品。任何新產品的吸收都可能很慢,特別是在通常用於眼藥水的領域,但最新數據非常令人鼓舞,並且延續了我們上個季度所分享的勢頭。
Since launching a 30-second ad in January across linear and connected TV, we've seen a 10 times increase in sales at major retailers with a positive story emerging in terms of repeat buyers. More than 10% of eye care professionals recommended Blink NutriTears in the first quarter, thanks to convincing data and finally having access to a once-a-day nutraceutical.
自從一月份在線上性和連網電視上推出 30 秒廣告以來,我們看到主要零售商的銷售額成長了 10 倍,回頭客數量也呈現正面動能。由於有令人信服的數據,並且最終可以獲得每日一次的營養保健品,第一季超過 10% 的眼科護理專業人士推薦 Blink NutriTears。
Uptake for Blink eye drops is equally as impressive. Our DTC campaign is driving that growth, but the upward trajectory can also be attributed to old school blocking and tackling. We're getting the product in front of eye care professionals through sampling and engagement at industry events, which is even more important following the release of two preservative-free Blink offerings in the first quarter.
Blink 眼藥水的吸收率同樣令人印象深刻。我們的 DTC 活動正在推動這一成長,但上升軌跡也可以歸因於老派的阻擋和鏟球。我們透過在行業活動中進行抽樣和參與的方式將產品展示給眼科護理專業人士,這在第一季度發布兩款不含防腐劑的 Blink 產品後變得更加重要。
All told, the Blink family of products, which includes eye drops, lens care and supplements, delivered 84% reported revenue growth year-over-year. Daily SiHy contact lenses continue to win over customers and consumers with 42% constant currency revenue growth in the first quarter. That growth was even higher at 56% in the US, where the full suite of offerings is available.
總而言之,Blink 系列產品(包括眼藥水、鏡片護理產品和補充劑)的收入年增了 84%。日拋型 SiHy 隱形眼鏡持續贏得客戶和消費者的青睞,第一季營收以固定匯率計算成長 42%。在提供全套服務的美國,這一成長率甚至更高,達到 56%。
The same will be true later this year in Japan, our second biggest market for contact lenses, when we expect to introduce a toric option. We expect to introduce multifocal and toric options in other markets in 2026, maintaining our thoughtful approach to expansion.
同樣的情況也將在今年稍後出現在我們第二大隱形眼鏡市場日本,屆時我們預計將推出散光鏡片。我們預計將於 2026 年在其他市場推出多焦點和散光鏡片,並繼續保持我們深思熟慮的擴張方式。
In the meantime, existing brands are filling the gap. Ultra monthly contact lenses is a prime example with 13% reported revenue growth in the first quarter despite a gradual industry shift towards daily lenses. Another Vision Care highlight worth noting is the March launch of Arise, a lens-fitting system that uses cloud-based technology to streamline the OrthoK lens design process. We believe this offering will help us build a foundation in the fast-growing and critical area of myopia control.
與此同時,現有品牌正在填補這一空白。超月拋型隱形眼鏡就是一個典型的例子,儘管產業逐漸轉向日拋型隱形眼鏡,但其第一季的營收仍成長了 13%。Vision Care 的另一個值得注意的亮點是 3 月推出的 Arise,這是一種鏡片配戴系統,使用基於雲端的技術來簡化 OrthoK 鏡片設計流程。我們相信,此項服務將幫助我們在快速發展且關鍵的近視控制領域奠定基礎。
This slide serves as a reminder that IOLs are not the entirety of our Surgical business, not even close. In fact, consumables, which delivered 5% constant currency revenue growth, account for roughly half of the business, while equipment with 9% constant currency revenue growth accounts for nearly a quarter. Those areas have not and will not be affected by enVista voluntary recall.
這張投影片提醒我們,IOL 並不是我們外科業務的全部,甚至還差得遠。事實上,消耗品收入以 5% 的固定匯率成長率成長,約佔業務的一半,而設備收入以 9% 的固定匯率成長率成長,約佔業務的四分之一。這些地區尚未受到且不會受到 enVista 自願召回的影響。
That said, implantables will continue to be a critical part of our growth going forward and feature prominently in our pipeline. I mentioned the pending LuxLife launch earlier. We also expect to unveil a new LuxSmart inserter within the next few weeks for select countries and anticipate a soft launch for enVista Envy in Europe later this year with a full rollout expected in early 2026.
也就是說,植入物將繼續成為我們未來成長的關鍵部分,並在我們的產品線中佔據突出地位。我之前提到即將推出的 LuxLife。我們也預計在未來幾週內為部分國家推出一款新的 LuxSmart 插入器,預計今年稍晚在歐洲試運行 enVista Envy,並預計在 2026 年初全面推出。
I'll close with my favorite slide, a top-line view of our refocused pipeline, which cuts across all businesses. Several of these products could be category disruptors, including a first-of-its-kind biomimetic contact lens that would optimize oxygen permeability, the first dual-action therapeutic to address both evaporative and inflammatory dry eye disease, the first product to treat ocular surface pain and the first glaucoma product to lower intraocular pressure and improve visual acuity.
我將以我最喜歡的幻燈片作為結束,這是我們重新調整後的管道的頂線視圖,該管道涵蓋所有業務。這些產品中有幾種可能會成為類別顛覆者,包括首創的可優化透氧性的仿生隱形眼鏡、第一種同時治療蒸發和發炎性乾眼症的雙重作用治療劑、第一種治療眼表疼痛的產品和第一種降低眼壓和改善視力的青光眼產品。
Others, most notably OTC offerings, leverage brand favorability with new science. We're in the process of initiating clinical trials for most of these products, which means we're making meaningful progress in our journey to significantly enhance the standard of care in eye health. That's what continues to motivate us every day.
其他產品,尤其是非處方藥,則利用新科學來提升品牌吸引力。我們正在對大多數產品進行臨床試驗,這意味著我們在顯著提高眼部保健標準的過程中取得了有意義的進展。這就是我們每天繼續前進的動力。
Operator, let's move to Q&A.
接線員,我們進入問答環節。
Operator
Operator
(Operator Instructions) Patrick Wood, Morgan Stanley.
(操作員指示)摩根士丹利的帕特里克·伍德。
Patrick Wood - Analyst
Patrick Wood - Analyst
Perfect. Thank you so much. Good morning, everyone. I'm going to skip over tariffs. I'm much more interested on the implantable side of things actually. Before the recall, Envy was -- we could all see it in the data, Envy was kind of kicking ass and doing very well in the US. You've obviously got what looks like a fairly aggressive assumption on the revenue line of a hit from the recall.
完美的。太感謝了。大家早安。我將跳過關稅問題。事實上,我對可植入方面的東西更感興趣。在召回之前,我們都可以從數據中看到,Envy 在美國表現非常出色,並且做得很好。顯然,你對召回帶來的收入做出了一個相當激進的假設。
How are you guys thinking about the total impact? How are you thinking about the effect that it has or hasn't had with customers? What are you hearing from the customer base? I'd love to dig into that. And then, I've got a quick follow-up on the same topic.
你們認為整體影響如何?您如何看待它對客戶產生或未產生的影響?您從客戶群聽到了什麼?我很想深入研究一下。然後,我對同一主題進行了快速跟進。
Brent Saunders - Chairman of the Board, Chief Executive Officer
Brent Saunders - Chairman of the Board, Chief Executive Officer
Sure. Thanks, Patrick. And I like the way you described Envy's performance. I don't know if I could get away with saying that, but thank you, in the first quarter at least. So, look, we made the important decision that really didn't require much thought, right, which is always to put the quality and safety of our products first.
當然。謝謝,派崔克。我喜歡你描述 Envy 的表現的方式。我不知道我是否可以這樣說,但至少在第一季還是要謝謝你。所以,你看,我們做出了這個重要的決定,這個決定真的不需要太多思考,對吧,那就是始終把我們產品的品質和安全放在第一位。
And we decided to make the recall when we started to see a signal on TASS. When you look at the work the team did to resolve the issue and identify the problem after a thorough investigation, we feel incredibly confident that we made the right decision also to return to market.
當我們開始看到塔斯社的訊號時,我們決定召回。當您看到團隊在徹底調查後解決問題並確定問題所在時,我們非常有信心,我們做出了重返市場的正確決定。
We were at ASCRS. I was there as most of the team was this weekend in Los Angeles. And so, we had a really great opportunity to interact with thousands of customers. And I think the message is clear, which is we earned a lot of trust by the way we moved swiftly to put patient safety first and the transparency in which we did it.
我們在 ASCRS。我和團隊中的大多數人這個週末都在洛杉磯。因此,我們有非常好的機會與數千名客戶互動。我認為訊息很明確,我們迅速採取行動,將病患安全放在首位,而且透明度很高,從而贏得了大量信任。
I heard overwhelmingly from a lot of KOLs that they plan to immediately return to implanting enVista as soon as the next week or two when supply is restored. And then, I've heard from other surgeons who said, let's give it a couple of weeks or a month given the immediacy of the onset of tests, so we should know pretty quickly, and that should settle the market.
我從許多 KOL 那裡聽到大量消息,他們計劃在供應恢復後一兩週內立即恢復植入 enVista。然後,我聽到其他外科醫生說,考慮到測試的開始時間,讓我們再等幾週或一個月,這樣我們就可以很快知道結果,這應該可以解決市場問題。
So, when I look at it, clearly, second quarter is what it is because it happened during second quarter. I do expect third quarter to start to see a pickup and my current thinking is by fourth quarter, we should start to restore trust and confidence and be back in business in a full force.
因此,當我看待它時,顯然,第二季度就是這樣,因為它發生在第二季度。我確實預計第三季度會開始出現回暖,我目前的想法是,到第四季度,我們應該開始恢復信任和信心,並全力恢復業務。
Patrick Wood - Analyst
Patrick Wood - Analyst
Super helpful.
超有幫助。
Brent Saunders - Chairman of the Board, Chief Executive Officer
Brent Saunders - Chairman of the Board, Chief Executive Officer
Does that make sense?
這樣有道理嗎?
Patrick Wood - Analyst
Patrick Wood - Analyst
It does. It dovetails nicely actually because to your point on ASCRS, I guess the second question is, we've seen J&J's number, we've got your number now, but certainly what we had been hearing a little bit for the US on the implantable side, and I understand you guys are much smaller in the US versus OUS, but for the US side on implantables, let's say, cataract volumes were actually pretty bad in the Q1.
確實如此。實際上,這非常吻合,因為對於您關於 ASCRS 的觀點,我想第二個問題是,我們已經看到了強生公司的數據,現在我們知道了您的數據,但當然,我們在植入方面聽到了一些關於美國的消息,我知道你們在美國比在美國規模小得多,但對於美國植入物方面,可以說,第一季度的白內障數量實際上相當糟糕。
I'd assume that would just be the premium side of things, just the economy et cetera -- blah, blah, blah, and we all saw Rx's numbers. But what are you hearing from your customers around total cataract volumes? I know that's less impactful for you guys given your position in the market, but I'm just really curious.
我認為這只是事物的高端方面,只是經濟等等——等等,我們都看到了 Rx 的數字。但是您從客戶那裡了解到了有關白內障總量的什麼資訊呢?我知道考慮到你們在市場中的地位,這對你們的影響較小,但我只是真的很好奇。
Brent Saunders - Chairman of the Board, Chief Executive Officer
Brent Saunders - Chairman of the Board, Chief Executive Officer
Yeah. I don't -- we don't have hard data, but I can tell you anecdotally, through the recall and even at ASCRS, I've been probably spending more time with cataract surgeons than any other customer for the last few months. And I think I would describe volumes as kind of normal. I don't think that there's a decline. I don't think there's a big increase either. I see it as very steady in the marketplace.
是的。我沒有——我們沒有確鑿的數據,但我可以根據軼事告訴你,透過召回,甚至在 ASCRS,在過去的幾個月裡,我與白內障外科醫生在一起的時間可能比任何其他顧客都多。我認為交易量是正常的。我不認為存在衰退。我也不認為會有太大的成長。我認為它在市場上非常穩定。
I think with respect to the categories where we see more growth, it's monofocal plus, and clearly, there our only competitor is J&J. So, they're going to benefit in the second quarter because of Aspire's recall. But I think when it comes to Envy, I think when you look at first quarter, even fourth quarter of last year, there was really nice adoption because of the quality of the lens and the quality of the outcome surgeons were achieving for patients. And that's what they want. They want a predictable strong outcome for a premium IOL.
我認為,就我們看到更多成長的類別而言,它是單焦點加,顯然,我們唯一的競爭對手是強生。因此,由於 Aspire 的召回,他們將在第二季受益。但我認為,就 Envy 而言,當你回顧去年第一季甚至第四季度時,你會發現它的採用率確實很高,因為它的鏡片質量很好,而且外科醫生為患者取得了很好的治療效果。這正是他們想要的。他們希望優質 IOL 能夠獲得可預測的良好效果。
Patrick Wood - Analyst
Patrick Wood - Analyst
Super. Thanks so much, guys.
極好的。非常感謝大家。
Operator
Operator
Young Li, Jefferies.
Young Li,傑富瑞。
Young Li - Analyst
Young Li - Analyst
All right, great. Thanks for taking our questions. I guess, to start, wanted to ask a little bit about your consumer exposed businesses. I was wondering if you can talk a little bit about what you saw from those segments in March or even April, if there's any cautiousness or slowdown. And then, if you can focus a little bit on US consumer as well as China consumer sentiment, that would be helpful.
好的,太好了。感謝您回答我們的問題。我想,首先我想問一下有關你們面向消費者的業務的情況。我想知道您是否可以談談您在三月甚至四月從這些領域看到的情況,是否存在任何謹慎或放緩的跡象。然後,如果你能稍微關註一下美國消費者和中國消費者的情緒,那將會很有幫助。
Brent Saunders - Chairman of the Board, Chief Executive Officer
Brent Saunders - Chairman of the Board, Chief Executive Officer
Yeah. So, it's actually, Young, a great question, and it's an interesting paradigm, right, because the data we see and even in April, we see strong consumption still. I think there's two things that you have to watch out, which is, I think, we're still going to see some continued destocking of inventory from retailers as they try to preserve cash or manage cash. We saw that last year in the drug channel. I think we're going to see it in a few other parts of the consumer channel over the coming year.
是的。所以,楊,這其實是一個很好的問題,也是一個有趣的範例,對吧,因為我們看到的數據,甚至在四月份,我們仍然看到強勁的消費。我認為有兩件事需要注意,那就是,我認為,我們仍然會看到零售商繼續減少庫存,因為他們試圖保留現金或管理現金。我們去年在藥品通路看到過這種情況。我認為我們將在未來一年內在消費者管道的其他幾個部分看到它。
And then, second, sentiment, right? When you look at the sentiment surveys out of Michigan and other places, obviously, they're quite concerning. That being said, the dichotomy exists, and we don't see it in the actual consumption yet. That being said, we probably have more resiliency than others, because most of what we sell are essential healthcare products, and so they tend to be less discretionary.
然後,第二,情緒,對吧?當你查看密西根州和其他地方的情緒調查時,顯然它們相當令人擔憂。話雖如此,這種二分法確實存在,但我們在實際消費中還沒有看到它。話雖如此,我們可能比其他公司更有彈性,因為我們銷售的大部分是必需的醫療保健產品,因此它們往往不太可自由支配。
And so, I think we feel cautiously optimistic about the consumer business on a go-forward basis. Demand looks really solid. And that includes China. I mean, even China, our best barometer in the first quarter is contact lenses, and we saw 6% growth in China in contact lenses. So, again, I understand the sentiment. We just don't see it in the consumption data.
因此,我認為我們對未來的消費業務持謹慎樂觀的態度。需求看起來確實很強勁。其中包括中國。我的意思是,即使在中國,我們第一季最好的晴雨表也是隱形眼鏡,我們看到中國隱形眼鏡的銷量成長了 6%。因此,我再次理解這種感受。我們只是在消費數據中看不到這一點。
Young Li - Analyst
Young Li - Analyst
All right, great. That's very helpful. I guess, one on tariffs, still a hot topic. You have a pretty diversified manufacturer footprint, lots of mitigation, potential efforts that you highlighted. I guess, just kind of curious, how quickly can you implement some of those things and thoughts on your ability to pass price on through to customers if needed?
好的,太好了。這非常有幫助。我想,關於關稅的話題仍然是一個熱門話題。你們擁有相當多樣化的製造商足跡、大量的緩解措施以及你們所強調的潛在努力。我想,只是有點好奇,您能多快實現其中的一些事情,以及在必要時您將價格轉嫁給客戶的能力?
Brent Saunders - Chairman of the Board, Chief Executive Officer
Brent Saunders - Chairman of the Board, Chief Executive Officer
Yeah. Let me take a stab at a high-level answer and then I'll turn it over to Sam. So, you're correct. I mean, most of our tariff exposure comes from the reciprocality of tariffs from China. In our current configuration, most of our surgical and a lot of our contact lens and solutions are manufactured in the US and exported to China. And so, that's a vast majority of our impact today.
是的。讓我試著給一個高層次的答案,然後我會把它交給 Sam。所以,你是對的。我的意思是,我們的關稅風險大部分來自於中國徵收的互惠關稅。按照我們目前的配置,我們的大部分手術眼鏡、大量隱形眼鏡和護理液都是在美國製造並出口到中國。這就是我們今天產生的影響的絕大部分。
I think as you look -- if you believe these tariffs are -- perhaps maybe the better way to think about it is you got to divide the mitigation strategies into kind of two categories, right? The things you can do immediately, which Sam can talk about in terms of inventory and utilizing free trade zones.
我認為,如果您認為這些關稅是——也許更好的思考方式是將緩解策略分為兩類,對嗎?您可以立即做的事情,Sam 可以從庫存和利用自由貿易區的角度來談論。
And then, the second is, if you believe these things are going to be long term, which as we know is a moving target almost on a daily basis, you can strategize in terms of moving production to other facilities in Europe or even Asia. That takes a little bit more time and then requires a little bit more investment. So, we're spending a lot of time on scenario planning and getting ready, but not pulling triggers yet on the second type of actions.
第二,如果你相信這些事情將是長期的,正如我們所知,這是一個幾乎每天都在變化的目標,你可以製定策略,將生產轉移到歐洲甚至亞洲的其他工廠。這需要多一點的時間,然後需要多一點的投資。因此,我們花了大量時間進行情境規劃和準備,但尚未採取第二類行動。
But Sam, maybe turn it over to you.
但是 Sam,也許可以把它交給你。
Sam Eldessouky - Chief Financial Officer, Executive Vice President
Sam Eldessouky - Chief Financial Officer, Executive Vice President
Sure. And the way we approach this, we took number of steps here and we took it quite seriously in terms of pulling together, I'll refer to the task force focused on tariffs. And I lead the work with our operation teams on this. And when you think about tariffs and you think about and reflect on the slides that we shared with you earlier today or earlier this morning, we are well positioned from a manufacturing point of view in the US.
當然。我們處理這個問題的方式是,我們採取了許多措施,我們在齊心協力方面非常認真,我將參考專注於關稅的工作小組。我帶領我們的營運團隊進行這項工作。當您考慮關稅並思考和反思我們今天早些時候或今天早上與您分享的幻燈片時,從美國製造業的角度來看,我們處於有利地位。
So, when you think about -- as Brent said, like when you look at our manufacturing, we're well positioned because of our manufacturing in the US. It's really the impact on how we actually move product from the US into China.
所以,正如布倫特所說,當你考慮我們的製造業時,你會發現,由於我們的製造業在美國,所以我們處於有利地位。這確實對我們如何將產品從美國運往中國產生了影響。
And with that, I think there's probably -- I'll break it up into the two-parts actions. I'll refer to it as step one, as no regret actions, which is things that we've already deployed and we'll continue to deploy such as inventory management, inventory movement, how we actually ship products in and out of certain locations and how we can be able to work through that part of it.
有了它,我想可能會有──我會把它分成兩部分行動。我將其稱為第一步,即不後悔的行動,這是我們已經部署並將繼續部署的事情,例如庫存管理、庫存移動、我們如何將產品實際運入和運出某些地點以及我們如何能夠完成這部分工作。
The second part of the actions are a little bit more critical to things to evaluate, because the situation continues to be fluid. It's a dynamic sort of environment right now with how things are continuing to evolve and news are changing quite a bit. And those implications will have a longer element, which we believe many of those steps that we'll take through that second phase will meaningfully offset the tariffs exposure we talked about this morning.
第二部分行動對於評估而言更為關鍵,因為情況仍在不斷變化。現在的環境是動態的,事物不斷發展,新聞也在不斷變化。這些影響將是長期的,我們相信,我們在第二階段採取的許多措施將有效地抵消我們今天早上談到的關稅風險。
However, they will also require elements of implementation, and those will include the pricing or changes in our actual supply chain streams in terms of how we and where we manufacture and ship products from. So, again, it's ongoing work. We're taking it seriously with all hands on deck in terms of focused on it. And I think we'll continue to monitor what happens from a positive point of view.
然而,它們也需要實施的要素,包括定價或改變我們實際的供應鏈流程,包括我們如何以及在哪裡製造和運輸產品。所以,這又是一項持續的工作。我們非常重視此事,並將全力以赴。我認為我們會繼續從正面的角度關注事態發展。
Brent Saunders - Chairman of the Board, Chief Executive Officer
Brent Saunders - Chairman of the Board, Chief Executive Officer
Yeah. I would add one other comment. Just you didn't ask the question, but if we did see tariffs in Pharmaceuticals, we're really insulated from that. Our US Pharmaceutical business is made all those products, Miebo, Xiidra and Generics and everything else are made in the US for the US.
是的。我想補充一則評論。只是你沒有問這個問題,但如果我們確實看到藥品關稅,我們實際上不會受到影響。我們的美國製藥業務生產所有這些產品,Miebo、Xiidra 和仿製藥以及所有其他產品均在美國生產,供美國使用。
Young Li - Analyst
Young Li - Analyst
All right, great. Very helpful.
好的,太好了。非常有幫助。
Operator
Operator
Joanne Wuensch, Citibank.
花旗銀行的 Joanne Wuensch。
Joanne Wuensch - Analyst
Joanne Wuensch - Analyst
Good morning, and thank you for taking the question. I want to just pause for a second on the contact lens market. I'd love to get your view on what you're seeing in the US and the [OUS] in terms of demand and little bit going to the question earlier of potential recessionary impacts on the business.
早上好,感謝您回答這個問題。我想暫時停頓一下,談談隱形眼鏡市場。我很想聽聽您對美國和 [OUS] 的需求情況的看法,以及之前關於經濟衰退對業務的潛在影響的問題。
But I'm also -- I'll throw my second question in here. Looking at slide 20 and you have one, two, three, four different contact lenses in queue and anything you could share with us about the products, what you're excited about or the timing would be fabulous. Thank you.
但我還要在這裡提出我的第二個問題。看幻燈片 20,您有一、二、三、四種不同的隱形眼鏡在排隊,您可以與我們分享有關產品的任何信息,您對什麼感到興奮或時機如何,這將是極好的。謝謝。
Brent Saunders - Chairman of the Board, Chief Executive Officer
Brent Saunders - Chairman of the Board, Chief Executive Officer
Yeah, absolutely. So, Joanne, as you know, the market data on contact lenses that we source is -- comes in, I guess, in a couple of weeks or a month. So, we don't have the actual data. So, I'll have to speak more based on what we're seeing in the market and anecdotal comments from customers.
是的,絕對是如此。所以,喬安妮,如你所知,我們獲得的隱形眼鏡市場數據是——我想,幾週或一個月後就會出來。所以,我們沒有實際數據。因此,我必須根據我們在市場上看到的情況和來自客戶的軼事評論來發表更多言論。
And we see continued mid-single-digit growth of the market. I think there are some of our competitors that have different selling models that had some destocking, just like we saw in our consumer business. That doesn't really impact us as much. But I think all in all, I think consumption or demand remains in that mid-single-digit kind of number.
我們看到市場繼續保持中等個位數成長。我認為我們的一些競爭對手採用了不同的銷售模式,並進行了一些去庫存化,就像我們在消費業務中看到的那樣。這其實對我們的影響並不大。但我認為總體而言,消費或需求仍將保持在中等個位數的水平。
I think in terms of the recession, when you go back and look at other recessions, and I don't think if we entered one, it would be perhaps as severe as the financial crisis-driven one. But there you still saw growth, albeit muted growth. But I think it is a fairly resilient market and people don't drop out of lens use during a recession. You may see less new starts, but not in a significant way. It would be a more modest impact.
我認為,就經濟衰退而言,當你回顧其他經濟衰退時,我認為如果我們進入一次衰退,其嚴重程度可能不會像金融危機引發的經濟衰退那麼嚴重。但你仍然可以看到成長,儘管成長速度緩慢。但我認為這是一個相當有彈性的市場,人們不會在經濟衰退期間停止使用隱形眼鏡。你可能會看到一些新的開始,但影響並不大。這會產生比較溫和的影響。
In terms of the pipeline, Yehia Hashad, our Head of R&D, is here. Do you want to just touch on some of your.
就管道而言,我們的研發主管 Yehia Hashad 在這裡。您是否想簡單談談您的一些事情?
Yehia Hashad - Executive Vice President - Research & Development, Chief Medical Officer
Yehia Hashad - Executive Vice President - Research & Development, Chief Medical Officer
Yeah, sure. Specifically in terms of the contact lenses, we continue to make substantial progress on the development of our biomimetic lenses. We're currently in the final optimization study within our clinic, but we're going for the big clinic, as we announced in JPMorgan, second half of the year and we'll start this study.
是的,當然。具體到隱形眼鏡方面,我們在仿生鏡片的研發上持續取得實質進展。我們目前正在診所內進行最後的優化研究,但我們將進入大型診所,正如我們在摩根大通宣布的那樣,我們將在今年下半年開始這項研究。
And then, we obviously also completed recruitment for our myopia contact lens and we are expecting to see some entry analysis data by beginning of 2026. We have also started the program on the premium FRP SiHy lens that will give us also longer duration. So, in terms of the pipeline for the contact lens in particular, we have some very exciting programs that are progressing and on track to deliver results.
然後,我們顯然也完成了近視隱形眼鏡的招募,我們預計到 2026 年初會看到一些入門分析數據。我們還啟動了優質 FRP SiHy 透鏡計劃,這將使我們的使用壽命更長。因此,特別是就隱形眼鏡的管道而言,我們有一些非常令人興奮的項目正在取得進展並有望取得成果。
Brent Saunders - Chairman of the Board, Chief Executive Officer
Brent Saunders - Chairman of the Board, Chief Executive Officer
And I would add, Joanne, I think also put aside the novelty and technology upgrades of some of these lenses, they were designed for purpose on existing -- to be made on existing manufacturing infrastructure. And so, thereby, solving one of the biggest issues and bringing new contact lenses to market is the large capital investment usually needed to ramp up manufacturing. We largely avoid that with this pipeline.
我想補充一點,喬安妮,我認為除了這些鏡頭的新穎性和技術升級之外,它們的設計目的是在現有的製造基礎設施上製造。因此,解決最大的問題之一並將新型隱形眼鏡推向市場通常需要大量的資本投資來提高生產效率。透過這條管道,我們基本上可以避免這種情況。
And so, very proud of the R&D team's ability to drive innovation on existing manufacturing platforms, which is really an added difficulty when trying to innovate and they did that well. I think I would just add one last thing on the pipeline. Clearly, we have the clinical trials for the Pharmaceutical programs, all starting in the second half of this year. And so, we're super excited about those programs. But also, Elios in our MIGS glaucoma, we hope to anticipate an approval by the end of the year. And so, we have a lot of work going on in R&D this year.
因此,我對研發團隊在現有製造平台上推動創新的能力感到非常自豪,這確實是嘗試創新時的一個額外困難,但他們做得很好。我想我只需在管道上添加最後一件事。顯然,我們已經對製藥計畫進行了臨床試驗,所有試驗都將在今年下半年開始。因此,我們對這些項目感到非常興奮。而且,我們希望 Elios 在 MIGS 青光眼治療方面能夠在今年年底前獲得批准。因此,我們今年在研發方面有很多工作要做。
Joanne Wuensch - Analyst
Joanne Wuensch - Analyst
Excellent. Thank you.
出色的。謝謝。
Operator
Operator
Larry Biegelsen, Wells Fargo.
富國銀行的拉里·比格爾森。
Unidentified Participant
Unidentified Participant
Hi, good morning. It's [Lei] calling in for Larry. Thanks for taking the questions. First, just going back to tariffs, Sam, you talked about tariff impact approximating 120 basis points to EBITDA margin this year. Can you give any thoughts on how we should think about the ramp through the year, just given how inventory rose through the P&L? I mean, we would assume Q2 margin impact would be less than 120 basis points and Q4 would be greater. Can you give any sort of order of magnitude or color? And I have a follow-up.
嗨,早安。我是 [Lei] 為 Larry 打來的。感謝您回答這些問題。首先,回到關稅問題,Sam,您談到了關稅對今年 EBITDA 利潤率的影響約為 120 個基點。考慮到庫存在損益表中的成長情況,您能否談談我們應該如何看待全年的成長?我的意思是,我們假設第二季的利潤率影響將低於 120 個基點,而第四季的利潤率影響將更高。你能給出任意數量級或顏色嗎?我還有一個後續問題。
Sam Eldessouky - Chief Financial Officer, Executive Vice President
Sam Eldessouky - Chief Financial Officer, Executive Vice President
Sure. So, when you think about the actions that we've taken, actually, we will protect it, I'll say, the first half of this year with the actions that have already been taken. So, I wouldn't expect that you'll see much of a meaningful impact with the tariffs in Q2 for us. I think when you think about it, it'll probably be more into the second half of this year, assuming all the policy stays in order and we don't have any additional development in terms of our other delays or other shifts that will take place.
當然。因此,當你想到我們已經採取的行動時,實際上,我想說,我們將在今年上半年透過已經採取的行動來保護它。因此,我預計第二季的關稅不會對我們產生太大的影響。我認為,當你考慮這一點時,它可能會在今年下半年出現,假設所有政策都保持有序,並且我們在其他延遲或其他轉變方面不會有任何其他發展。
So again, it's a very dynamic situation, Lei. So -- but for -- as you start to think about your own modeling in terms of how we're thinking about it, Q2 is well protected. It will probably be more of a, at this point, it's second half.
所以,雷,這又是一個非常動態的情況。所以——但是——當您開始根據我們的想法來思考您自己的模型時,Q2 受到了很好的保護。從目前來看,這可能更像是下半場。
Unidentified Participant
Unidentified Participant
Got it. And would you say second half, Q3, Q4 would be fairly balanced? Or would you expect a ramp from Q3 to Q4?
知道了。您認為下半年、第三季和第四季會相當平衡嗎?或者您預計從第三季到第四季會出現上升趨勢?
Sam Eldessouky - Chief Financial Officer, Executive Vice President
Sam Eldessouky - Chief Financial Officer, Executive Vice President
I would say it's -- at this point, I would say it's probably well balanced. Again, it depends also the mitigating actions. I view this as a point of time, right, because I think we're -- again, we're not standing still here without taking action. So, there'll be more actions that we'll continue to deploy that we would expect that will continue to mitigate the 120 basis points as we look into the second half.
我想說的是——就目前而言,我想說它可能已經很平衡了。再次,這也取決於緩解措施。我認為這是一個時間點,對,因為我認為我們——再說一次,我們不會停滯不前而不採取行動。因此,我們將繼續採取更多行動,預計在下半年這些行動將繼續緩解 120 個基點的壓力。
Brent Saunders - Chairman of the Board, Chief Executive Officer
Brent Saunders - Chairman of the Board, Chief Executive Officer
Right. I think it's also important, Lei, to recognize we're basing our assumptions off of policy that was -- that seems to change every day. And so, we're looking at the most stringent policy, which is essentially no change, many of these tariffs going back into effect in June after the 90-day pause.
正確的。雷,我認為同樣重要的是要認識到,我們是根據政策做出假設的——而政策似乎每天都在變化。因此,我們正在考慮最嚴格的政策,基本上沒有任何變化,許多關稅將在 90 天的暫停後於 6 月重新生效。
But if those -- if deals are cut or extensions are given and clearly if a negotiation with China could happen, then this could look very different.
但如果達成協議或延長協議,並且顯然可以與中國進行談判,那麼情況可能會大不相同。
Unidentified Participant
Unidentified Participant
Got it. So, this is essentially, call it, worst case type of scenario based on what you know today?
知道了。那麼,根據您今天所了解的情況,這基本上就是最壞的情況?
Brent Saunders - Chairman of the Board, Chief Executive Officer
Brent Saunders - Chairman of the Board, Chief Executive Officer
You would like to think that, but I think given the way the President announces tariffs, it's hard to predict that he couldn't make them higher, but you got to think common sense wise that this is the worst case, right?
你可能會這麼想,但我認為,考慮到總統宣布關稅的方式,很難預測他不會提高關稅,但你必須根據常識認為這是最糟糕的情況,對嗎?
Unidentified Participant
Unidentified Participant
Got it. Okay. That's super helpful. And for my follow-up, on Xiidra, as you said, prescription volume has been growing really well, pretty solid. And you said the headwinds for Q1 were as expected. Your expectation for the full year in terms of the headwinds, have that changed? And should we think -- how should we think about Xiidra growth through the year? Should we expect sales to grow sequentially based on volume growth? Thank you.
知道了。好的。這非常有幫助。至於我對 Xiidra 的後續觀察,正如您所說,處方量增長確實很好,相當穩健。您說第一季的不利因素正如預期的那樣。您對全年面臨的不利因素的預期有變化嗎?我們應該思考—我們應該如何看待 Xiidra 全年的成長?我們是否應該預期銷售額會隨著銷售量的成長而持續成長?謝謝。
Brent Saunders - Chairman of the Board, Chief Executive Officer
Brent Saunders - Chairman of the Board, Chief Executive Officer
Yeah. So, you're exactly right. So, last year, we probably talked almost every quarter about anticipated gross to net headwinds in '25, and those are why we say they were expected. That being said, I think when you look at the strategy for Xiidra in particular, it was really a two-part strategy. One was to gain access to grow volume. Seeing about 14% TRx volume on Xiidra certainly confirms that, that part of the strategy is working.
是的。所以,你說得完全正確。因此,去年我們幾乎每個季度都會談論 2025 年預計的總淨逆風,這就是我們說它們是預料之中的。話雖如此,我認為當你具體看一下 Xiidra 的戰略時,它實際上是一個由兩部分組成的戰略。一是獲得成長量的途徑。看到 Xiidra 上約 14% 的 TRx 交易量無疑證實了策略的一部分正在發揮作用。
But now, we have to pull through the -- profitability through the P&L. And that is helped, in part, by seasonality, right? As you go through the year, the first quarter because of copays and deductibles is always the weakest. The fourth quarter is always the best in that regard. But we are also putting in other programs that go into effect in the next month or two to continue to focus on improving profitability while we continue to try to expand access.
但現在,我們必須透過損益表來實現獲利。這在某種程度上是受到季節性的影響,對嗎?回顧一年,由於共付額和免賠額的原因,第一季總是最疲軟的。從這個角度來說,第四節總是最好的。但我們也將在未來一兩個月內實施其他計劃,繼續致力於提高獲利能力,同時繼續努力擴大訪問管道。
Sam Eldessouky - Chief Financial Officer, Executive Vice President
Sam Eldessouky - Chief Financial Officer, Executive Vice President
And on your last part of your question, in terms of the guidance for the full year, it still remains unchanged for us. And I think that was -- we clarified that as we were putting out the bridge for the guidance, we changed the guidance on the enVista recall. Everything else remained unchanged.
關於您問題的最後一部分,就全年指導而言,我們的指導仍然保持不變。我認為——我們澄清說,當我們為指導建造橋樑時,我們改變了有關 enVista 召回的指導。其餘一切都保持不變。
Brent Saunders - Chairman of the Board, Chief Executive Officer
Brent Saunders - Chairman of the Board, Chief Executive Officer
Yeah. I mean, keep in mind, first quarter for a product like Xiidra will have the highest impact from gross to net because of the higher copay deductibles patients face in that quarter.
是的。我的意思是,請記住,對於像 Xiidra 這樣的產品來說,第一季的毛利對淨利的影響將是最大的,因為該季度患者面臨的共付額較高。
Operator
Operator
Douglas Miehm, RBC Capital.
道格拉斯‧米姆(Douglas Miehm),加拿大皇家銀行資本管理公司(RBC Capital)。
Douglas Miehm - Analyst
Douglas Miehm - Analyst
Yeah. Thank you, and good morning. Just on pharmaceutical tariffs, if they were introduced, what I'm curious about is where the intellectual property is held for the likes of Miebo and Xiidra and anything else of importance relative to where they're manufactured and sold and what the implications could be there?
是的。謝謝,早安。僅就藥品關稅而言,如果實施了這些關稅,我好奇的是 Miebo 和 Xiidra 等公司的知識產權在哪裡,以及與這些藥品的生產和銷售地點相關的其他重要信息,以及可能產生什麼影響?
Brent Saunders - Chairman of the Board, Chief Executive Officer
Brent Saunders - Chairman of the Board, Chief Executive Officer
Yeah. So, to be fair and Sam can touch on the IP, but the reality is its country of origin where they're manufactured is what the tariffs have been based on to date. And all -- both Miebo and Xiidra and all of our pharmaceutical products that we sell in the United States are made in the US. They're either made at CMOs in the US or in our facility in Tampa, which is quite large.
是的。因此,公平地說,Sam 可以談到智慧財產權,但事實是,迄今為止,關稅的依據是其製造國的原產國。而且,Miebo、Xiidra 以及我們在美國銷售的所有藥品都是在美國生產的。它們要么在美國的 CMO 生產,要么在我們位於坦帕的工廠生產,該工廠規模相當大。
From a competitive basis, I think that, that is -- if we solve pharmaceutical tariffs, that's a good outcome for us. And as much as US Generics was a laggard, all of our US Generics are made in our Tampa facility, and that would be a part of the business that would be more sensitive to tariffs, given the lower margins of our competitors. And so, I think we're well positioned if, in fact, we see tariffs on pharmaceuticals.
從競爭的角度來說,我認為,如果我們解決藥品關稅問題,對我們來說是一個好的結果。儘管美國仿製藥業發展緩慢,但我們所有的美國仿製藥都是在坦帕工廠生產的,考慮到我們競爭對手的利潤率較低,這部分業務對關稅更為敏感。因此,我認為,如果我們確實看到對藥品徵收關稅,我們將處於有利地位。
But the IP, Sam, is probably.
但 IP,Sam,很可能是。
Sam Eldessouky - Chief Financial Officer, Executive Vice President
Sam Eldessouky - Chief Financial Officer, Executive Vice President
Yeah. So, we have majority of our IPs sitting in Ireland. I think we've commented on that before, and that's part of our overall sort of planning in terms of where we hold IP and our tax structure.
是的。因此,我們的大多數 IP 都位於愛爾蘭。我想我們之前已經對此發表過評論,這是我們在知識產權持有地和稅收結構方面的整體規劃的一部分。
Douglas Miehm - Analyst
Douglas Miehm - Analyst
Okay, perfect. And then, just my follow-up question. Brent, you commented on a couple -- your favorite slide and a couple of opportunities. Could you expand on the glaucoma product and the timing of when we might see that introduced? Thank you.
好的,完美。然後,我再問一個後續問題。布倫特,你評論了一些你最喜歡的幻燈片和一些機會。您能否詳細介紹青光眼產品以及我們何時可能推出該產品?謝謝。
Brent Saunders - Chairman of the Board, Chief Executive Officer
Brent Saunders - Chairman of the Board, Chief Executive Officer
Yeah. I'm going to -- since Yehia is here and he's the expert, I'll let Yehia answer that.
是的。我要--既然葉海亞在這裡,而且他是專家,我就讓葉海亞來回答這個問題。
Yehia Hashad - Executive Vice President - Research & Development, Chief Medical Officer
Yehia Hashad - Executive Vice President - Research & Development, Chief Medical Officer
Yeah. So, the glaucoma product, actually, we are now in the phase of preparing all the necessary formulation and optimization of the formulation. We acquired this asset end of last year in December actually. The asset we acquired had clinical data from a study of about 60 patients that demonstrated clearly that this alpha-2 agonist is a new chemical entity, has the ability to reduce intraocular pressure, but it showed positive results on two functional outcomes.
是的。因此,對於青光眼產品,實際上,我們現在正處於準備所有必要配方和優化配方的階段。實際上,我們是在去年 12 月底收購了這項資產。我們獲得的資產有來自約 60 名患者的研究的臨床數據,這些數據清楚地表明這種 α-2 激動劑是一種新的化學實體,具有降低眼壓的能力,但它在兩種功能結果上顯示出積極的結果。
One of them was the low luminance visual acuity, and the other one was the microperimetry or the visual field. And this is based actually matching with the hypothesis on its mechanism of action. So, we -- what we currently doing are just doing optimization of the formulation and we're going to start another confirmatory Phase 2 study. We plan to start this around November timeframe and it should actually not be a long study because it's a confirmatory study, so it should be about six months study.
其中一個是低亮度視力,另一個是微視野或視野。這實際上是基於與其作用機制的假設相吻合的。所以,我們——我們目前正在做的只是優化配方,我們將開始另一個確認性的第二階段研究。我們計劃在 11 月左右開始這項研究,但這實際上不是一個長期的研究,因為這是一項確認性研究,所以應該需要大約六個月的研究。
And the idea is to replicate the results of what we have seen in the first study. If this is positive, we can go directly to Phase 3 and this would be the first IOP lowering agent that is associated with functional improvement in terms of visual acuity and microperimetry.
我們的想法是複製我們在第一項研究中看到的結果。如果結果是正面的,我們可以直接進入第 3 階段,這將是第一個與視力和微視野功能改善相關的降低眼壓藥物。
Brent Saunders - Chairman of the Board, Chief Executive Officer
Brent Saunders - Chairman of the Board, Chief Executive Officer
Yeah, which is when I talk to glaucoma specialist, that is kind of the Holy Grail. And so, we're very excited about the product, but we need to do the work to confirm our findings and then move aggressively into Phase 3.
是的,當我與青光眼專家交談時,這就像聖杯一樣。因此,我們對該產品感到非常興奮,但我們需要做一些工作來確認我們的發現,然後積極進入第三階段。
Yehia Hashad - Executive Vice President - Research & Development, Chief Medical Officer
Yehia Hashad - Executive Vice President - Research & Development, Chief Medical Officer
And we have to remember that the unmet medical need is huge because currently all treatments are addressing the just lowering intraocular pressure. However, patients are still losing vision despite being treated for IOP lowering agents. So, this is a great opportunity to address this huge unmet medical need as well.
我們必須記住,未滿足的醫療需求是巨大的,因為目前所有的治療都只是解決降低眼壓的問題。然而,儘管接受了降眼壓藥物治療,患者的視力仍在下降。因此,這也是解決這一巨大的未滿足醫療需求的絕佳機會。
Douglas Miehm - Analyst
Douglas Miehm - Analyst
Thank you.
謝謝。
Operator
Operator
Matt Miksic, Barclays.
巴克萊銀行的馬特‧米克西克 (Matt Miksic)。
Matt Miksic - Analyst
Matt Miksic - Analyst
Hi, thanks so much for taking the questions, and congrats on sort of getting through and getting back to the market on the recalled products. On that front, off to a pretty good start, as you talked about, in the last year and into early this year.
嗨,非常感謝您回答這些問題,並祝賀召回產品順利通過審核並重新進入市場。在這方面,正如您所說,去年和今年年初已經有了相當好的開始。
Anything else in Surgical, whether it's equipment or any of the strategies that folks have pursued around adjustable or certain next-gen lenses that you think would be important to sort of get a bigger footprint over time in that business? And I have one follow-up.
外科手術方面還有其他事項嗎?無論是設備還是人們在可調節或某些下一代鏡片方面所追求的任何策略,您認為這些對於隨著時間的推移在該業務中獲得更大的影響力很重要嗎?我還有一個後續問題。
Brent Saunders - Chairman of the Board, Chief Executive Officer
Brent Saunders - Chairman of the Board, Chief Executive Officer
Yeah. So absolutely. And we are focused on other areas. I mentioned earlier our entry into the MIGS glaucoma space with -- we're still anticipating our approval at the very end of the year this year for a launch beginning of '26. We continue to do the EDOF enVista Beyond studies, and that is enrolling now and that study is going.
是的。絕對是如此。我們也關注其他領域。我之前提到過,我們將進入 MIGS 青光眼領域——我們仍然期待在今年年底獲得批准,並於 26 年初推出。我們將繼續進行 EDOF enVista Beyond 研究,目前正在招募學生並進行研究。
So, that would finish out our premium IOL offerings. We have the new Stellaris program at the end of '26, seeNOVA, it's called. We're very excited about that. And so, there's a lot of work, including new lasers, [femto] and everything else. So, lots of work.
這樣,我們的優質 IOL 產品就全部完成了。我們在 26 年底推出了新的 Stellaris 計劃,它被稱為 seeNOVA。我們對此感到非常興奮。因此,有很多工作要做,包括新的雷射、[飛秒] 和其他一切。所以,有很多工作要做。
I don't know, Yehia, anything else you'd comment on.
我不知道,葉海亞,您還有什麼要評論的。
Yehia Hashad - Executive Vice President - Research & Development, Chief Medical Officer
Yehia Hashad - Executive Vice President - Research & Development, Chief Medical Officer
No, actually, we continue to drive actually all the franchises from implantable to the equipments. As you mentioned from an equipment perspective, we have the seeNOVA. Teneo, we approved the myopia-only indication. We are actually just completing the study for the hyperopia and we should be also submitting an indication for the hyperopia for Teneo.
不,實際上,我們實際上繼續推動從植入物到設備的所有特許經營。正如您從設備角度提到的,我們有 seeNOVA。Teneo,我們批准了僅適用於近視的適應症。實際上,我們剛剛完成了遠視研究,我們也應該提交 Teneo 的遠視適應症。
And then, we don't have to forget also that we have a complete range of intraocular lenses, which is the LuxSmart and LuxLife, which is under the cutting-edge technology. We are expecting the approval of the LuxSmart very soon actually in the European Union. And it's a slightly different platform than the enVista, because they use a different optical design diffractive technology. So, we are really very excited about all these programs that's going and should be delivering for us on the short term as well.
然後,我們也不必忘記,我們擁有全系列的人工水晶體,即採用尖端技術的 LuxSmart 和 LuxLife。我們期待 LuxSmart 很快就會在歐盟獲得批准。它的平台與 enVista 略有不同,因為它們使用了不同的光學設計衍射技術。因此,我們對所有這些正在進行的項目感到非常興奮,這些項目也應該在短期內為我們帶來成果。
Matt Miksic - Analyst
Matt Miksic - Analyst
That's great. Thank you. And just a follow-up, I think we've all liked to sort of believe the tariffs are going to have settled back down, but one of the things that was sort of hopeful during this year and fairly active was general activity on the M&A front. You've been active for the past 12, 24 months. We'd love to get a sense of your posture there. How the environment is affecting your activity level or thoughts on building out the portfolio strategically given the environment?
那太棒了。謝謝。再問一個問題,我想我們都願意相信關稅將會回落,但今年令人充滿希望且相當活躍的事情之一是併購方面的普遍活動。過去 12、24 個月以來您一直很活躍。我們很想了解您在那裡的姿勢。環境如何影響您的活動水平或您在特定環境下策略性地建立投資組合的想法?
Brent Saunders - Chairman of the Board, Chief Executive Officer
Brent Saunders - Chairman of the Board, Chief Executive Officer
Yeah. I think you're right. Everybody was expecting some sort of bonanza in M&A, and clearly that hasn't materialized. And that's because just like capital markets, M&A markets don't like uncertainty and tariffs certainly create some turmoil, particularly the ever-changing posture around tariffs.
是的。我認為你是對的。每個人都期待著併購能帶來某種豐厚回報,但顯然這並沒有實現。這是因為,就像資本市場一樣,併購市場不喜歡不確定性,而關稅肯定會造成一些混亂,尤其是圍繞關稅的不斷變化的態勢。
The other -- I think the other effect we're seeing is a slowdown in venture funding in this space. And so, that's probably a net positive for us as some of these really interesting technologies that are small startup companies are looking for sources of capital that allows us to get early looks or early rights to technologies at prices probably we couldn't have thought about in the last year or two.
另外——我認為我們看到的另一個影響是該領域的風險投資放緩。因此,這對我們來說可能是一件好事,因為一些真正有趣的技術,即小型新創公司,正在尋找資金來源,使我們能夠以過去一兩年內我們可能無法想像的價格提前了解或獲得技術早期使用權。
But in terms of M&A, we're not looking at doing any big M&A this year. We continue to really hone in on looking for intellectual property in early-stage technologies that can bolster Yehia's already pretty robust pipeline.
但就併購而言,我們今年不打算進行任何大型併購。我們將繼續致力於尋找早期技術的智慧財產權,以增強 Yehia 已經相當強大的產品線。
Matt Miksic - Analyst
Matt Miksic - Analyst
Very helpful. Thanks.
非常有幫助。謝謝。
Operator
Operator
Robbie Marcus, JPMorgan.
摩根大通的羅比·馬庫斯。
Robbie Marcus - Analyst
Robbie Marcus - Analyst
Great. Thank you for taking the questions. I'll squeeze the two into one here. I appreciate that we all hope tariffs go away and they're transitory, but you're the only company so far in MedTech that hasn't included in the guide. And as of now, they're real and policy. And by my math, some like 20% to 25% EPS headwind for the second half this year, 40% to 50% without mitigation headwind to EPS next year.
偉大的。感謝您回答這些問題。我將在這裡把兩者合併為一。我知道我們都希望關稅取消,而且這只是暫時的,但到目前為止,你們是醫療科技領域唯一一家尚未被列入指南的公司。截至目前,它們都是真實的,並且是政策性的。根據我的計算,今年下半年每股盈餘將面臨 20% 至 25% 的不利因素,而明年每股盈餘將面臨 40% 至 50% 的不利因素(若無緩解)。
So, I'm wondering if the tariffs hold, how do you feel about your ability to mitigate the tariffs, assuming that number you gave was a gross number? And are you at risk of tripping any of the debt covenants given the meaningful run rate impact? Thanks a lot.
所以,我想知道,如果關稅保持不變,假設您給的數字是一個總數,您認為自己有能力降低關稅嗎?考慮到顯著的運行率影響,您是否面臨違反任何債務契約的風險?多謝。
Brent Saunders - Chairman of the Board, Chief Executive Officer
Brent Saunders - Chairman of the Board, Chief Executive Officer
Yeah. So, let me start just philosophically and then Sam can provide more color. I think the reason we're handling it the way we did philosophically is, one, to provide transparency on the impact and the actions we're taking, but two, given that it seems to change on a daily, weekly basis, we don't want to have to update guidance every time there's a press conference at the White House either.
是的。因此,讓我先從哲學角度開始,然後 Sam 可以提供更多細節。我認為我們以這種方式處理這個問題的原因在於,第一,為了對影響和我們正在採取的行動保持透明度;第二,鑑於情況似乎每天、每週都在發生變化,我們也不想每次在白宮舉行新聞發布會時都要更新指導意見。
And so, I think just quantifying in a very transparent way what those the current tariffs impact and mitigation strategies are is the cleanest way for us to handle it. Certainly, if they stay into effect and if you believe that that's -- the current status is the permanent status, that would change the way I think we handle it. I don't think that that's the most likely outcome, but again, it's such a fluid situation. I think this is the right way to handle it.
因此,我認為以非常透明的方式量化當前關稅的影響和緩解策略是我們處理這個問題的最乾淨的方式。當然,如果它們繼續有效,如果你相信——當前狀態是永久狀態,那麼我認為我們處理它的方式就會改變。我不認為這是最有可能的結果,但情況確實非常不穩定。我認為這是處理此事的正確方法。
But Sam, you wanted to talk about the other parts?
但是山姆,你想談談其他部分嗎?
Sam Eldessouky - Chief Financial Officer, Executive Vice President
Sam Eldessouky - Chief Financial Officer, Executive Vice President
No, that's exactly right. And Robbi, when you think about it -- again, it's a very dynamic global environment, right? Things changes, if not, on a weekly basis, sometimes on a daily basis based on what happens here. So, I think the two things that you have to keep in mind is there's a movement on the tariffs itself and the policy setting, and I will leave that to the policy setting sort of aspect of it in terms of what they ultimately decide what the tariffs are.
不,完全正確。羅比,如果你仔細想想的話——這是一個非常動態的全球環境,對吧?根據這裡發生的事情,事情每週都會發生變化,有時甚至每天都會發生變化。因此,我認為你必須記住的兩件事是關稅本身和政策制定的變動,至於他們最終決定關稅是多少,我將把這留給政策制定方面來決定。
But the other part, which is continues to be an important factor that you -- is what we control and the levers that we have in our sort of control to be able to execute on. And I tried to highlight it on the prepared remarks and also in the previous question, which is, if you think about it, there's multiple levers that we, I'll call it, are fully executable. We are in either already executed them or in the process of executing them, and they are offsetting elements of that tariffs.
但另一部分,仍然是一個重要的因素——是我們控制什麼,以及我們能夠控制哪些槓桿來執行。我試著在準備好的發言和上一個問題中強調這一點,也就是說,如果你仔細想想,我們會發現有多個槓桿,我稱之為完全可執行的。我們要么已經執行了這些措施,要么正在執行過程中,它們正在抵消關稅的部分內容。
There's other levers as well that we'll be able to execute that will be meaningfully offsetting the exposure that we just talked about today. So, the reason why I highlight that point is, it's two moving pieces. The tariffs itself, the (inaudible) itself is moving. We don't know where that is going to ultimately end up landing, but there's also multiple elements in our control that we're taking action on to be able to offset that. So that itself should give you a sense of the fact that we're why we didn't put into the guidance because this continued to be a moving target here.
我們還可以利用其他手段來有效抵消我們今天剛剛談到的風險敞口。所以,我強調這一點的原因是,這是兩個活動的部分。關稅本身,(聽不清楚)本身正在改變。我們不知道最終結果會如何,但我們正在採取行動來抵消我們控制的多個因素。所以這本身應該讓你明白為什麼我們沒有將其納入指導,因為這仍然是一個移動的目標。
I would not sort of take the liberty of trying to normalize that number for a '26 or anything beyond that at this point because of the elements of the moving element nature of it as well as the levers that we're still executing that this should not give you a run rate -- a reasonable run rate as you think forward going beyond '25.
目前,我不會擅自嘗試將這個數字標準化為 26 年或以後的任何數字,因為它的移動元素性質以及我們仍在執行的槓桿因素,這不應該給你一個運行率 - 當你考慮超越 25 年時,這是一個合理的運行率。
And then, on the last part of your question in terms of debt covenants, we are in full compliance. Again, we're looking at that with multiple levers, multiple elements with our guidance where we're in full compliance with our debt.
然後,關於您問題的最後一部分,即債務契約,我們完全遵守。再次強調,我們正在透過多種手段、多種因素來考慮這個問題,並結合我們的指導,確保我們完全履行債務。
Brent Saunders - Chairman of the Board, Chief Executive Officer
Brent Saunders - Chairman of the Board, Chief Executive Officer
Great. Thank you, Robbie. Operator, just some closing thoughts. Thanks to everyone who joined the call. We look forward to continuing to engage around our business. I'd like to end with just thanking our team around the world.
偉大的。謝謝你,羅比。接線員,我只想說幾句結束語。感謝所有參加電話會議的人。我們期待繼續參與我們的業務。最後,我想感謝我們在世界各地的團隊。
Clearly, it was a solid quarter despite some bumps in the road. But I think when you see an issue like we saw with enVista, how a team responds is so critically important and the focus on patient safety first and the absolute mindset of finding the root cause and the amount of hard work our team demonstrated is a testament to their grittiness, to their commitment to patient safety and their commitment to our company and our customers.
顯然,儘管遇到了一些困難,但本季的業績依然穩健。但我認為,當你看到像我們在 enVista 上看到的問題時,團隊如何應對至關重要,將患者安全放在第一位、絕對致力於尋找根本原因,以及我們團隊所表現出的辛勤工作證明了他們的堅韌、他們對患者安全的承諾以及對我們公司和客戶的承諾。
So, a lot of learnings there and really proud of how the team reacted to a difficult situation. We look forward to keeping you updated and we'll talk to you soon. Thank you so much.
因此,我們學到了很多東西,並且對團隊如何應對困難情況感到非常自豪。我們期待向您通報最新情況,並很快與您聯繫。太感謝了。
Operator
Operator
Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.
謝謝。會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。