Glaukos Corp (GKOS) 2023 Q2 法說會逐字稿

Welcome to Glaukos Corporation's Second Quarter 2023 Financial Results Conference Call. Copies of the company's press release and quarterly summary document both issued after the market closed today are available at www.glaukos.com. (Operator Instructions) This call is being recorded, and an archived replay will be available online in the Investor Relations section at www.glaukos.com. I will now turn the call over to Chris Lewis, Vice President of Investor Relations and Corporate Affairs.

歡迎參加 Glaukos Corporation 2023 年第二季度財務業績電話會議。今天收盤後發布的公司新聞稿和季度摘要文件的副本可在 www.glaukos.com 上獲取。 （操作員說明）本次電話會議正在錄音，存檔的重播將在 www.glaukos.com 的投資者關係部分在線提供。我現在將把電話轉給投資者關係和公司事務副總裁克里斯劉易斯。

Thank you, and good afternoon. Joining me today are Glaukos Chairman and CEO, Tom Burns; President and COO, Joe Gilliam; and CFO, Alex Thurman.

謝謝你，下午好。今天加入我的是 Glaukos 董事長兼首席執行官 Tom Burns；總裁兼首席運營官喬·吉列姆；和首席財務官亞歷克斯·瑟曼。

Similar to prior quarters, the company has posted a document on its Investor Relations website under the Financials and Filings Quarter Results section titled Quarterly Summary. This document is designed to be -- to provide the investment community with a summarized and easily accessible reference document that details the key effects associated with the quarter, the state of the company's business objectives and strategies and any forward statements or guidance we may make. This document is designed to be read by investors before the regularly scheduled quarterly conference call.

與前幾個季度類似，該公司在其投資者關係網站上的“財務和文件季度業績”部分發布了一份名為“季度摘要”的文件。本文件旨在為投資界提供一份總結性且易於訪問的參考文件，詳細說明與本季度相關的關鍵影響、公司業務目標和戰略的狀況以及我們可能做出的任何前瞻性陳述或指導。本文件旨在供投資者在定期安排的季度電話會議之前閱讀。

As such, for this call, we will make brief prepared remarks and transition into a question-and-answer session.

因此，對於這次電話會議，我們將發表簡短的準備好的發言，然後過渡到問答環節。

To ensure ample time and opportunity to address everyone's questions, we request that you limit yourself to one question and one follow-up. If you still have additional questions, you may get back into the queue.

為了確保有足夠的時間和機會來回答每個人的問題，我們要求您只提出一個問題和一項後續行動。如果您還有其他問題，可以返回隊列。

Please note that all statements other than statements of historical facts made on this call that address activities, events or developments we expect, believe, or anticipate will or may occur in the future are forward-looking statements.

請注意，除本次電話會議中的歷史事實陳述外，涉及我們預期、相信或預計未來將或可能發生的活動、事件或發展的所有陳述均為前瞻性陳述。

These include statements about our plans, objectives, strategies and prospects regarding, among other things, our sales, products, pipeline technologies and clinical trials, U.S. and international commercialization, market development efforts, efficacy of our current and future products, competitive market position, regulatory strategies and reimbursement for our products, financial condition and results of operations as well as the expected impact of general macroeconomic conditions including foreign currency fluctuations on our business and operations.

其中包括有關我們的計劃、目標、戰略和前景的聲明，其中包括我們的銷售、產品、管道技術和臨床試驗、美國和國際商業化、市場開發工作、我們當前和未來產品的功效、競爭市場地位、我們產品的監管策略和報銷、財務狀況和經營業績以及一般宏觀經濟狀況（包括外幣波動）對我們業務和運營的預期影響。

These statements are based on current expectations about future events affecting us and are subject to risks, uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control. Therefore, they may cause our actual results to differ materially from those expressed or implied by forward-looking statements. Review today's press release and our recent SEC filings for more information about these risk factors. You'll find these documents in the Investors section of our website at www.glaukos.com.

這些陳述基於對影響我們的未來事件的當前預期，並受到與我們的運營和業務環境有關的風險、不確定性和因素的影響，所有這些都難以預測，其中許多超出了我們的控制範圍。因此，它們可能導致我們的實際結果與前瞻性陳述明示或暗示的結果存在重大差異。請查看今天的新聞稿和我們最近向 SEC 提交的文件，了解有關這些風險因素的更多信息。您可以在我們網站 www.glaukos.com 的投資者部分找到這些文件。

Finally, please note that during today's call, we will also discuss certain non-GAAP financial measures, including results on an adjusted basis. We believe these financial measures can facilitate a more complete analysis and greater transparency into Glaukos' ongoing results of operations, particularly when comparing underlying results from period to period. Please refer to the tables in our earnings press release available in the Investor Relations section of our website. For a reconciliation of these measures to the most directly comparable GAAP financial measure.

最後，請注意，在今天的電話會議中，我們還將討論某些非公認會計準則財務指標，包括調整後的結果。我們相信這些財務指標可以促進對 Glaukos 持續經營業績進行更完整的分析並提高透明度，特別是在比較不同時期的基本業績時。請參閱我們網站投資者關係部分中的收益新聞稿中的表格。將這些指標與最直接可比的 GAAP 財務指標進行調節。

With that, I will turn the call over to Glaukos Chairman and CEO, Tom Burns.

接下來，我將把電話轉給 Glaukos 董事長兼首席執行官湯姆·伯恩斯 (Tom Burns)。

Okay. Thanks again, Chris. Good afternoon to all, and thank you all for joining us. Today, Glaukos reported record second quarter consolidated net sales of $80.4 million, up 11% versus the year ago quarter. These second quarter results reflected record sales and continued strong performance across our international glaucoma and Corneal Health franchises alongside the reemerging growth in our U.S. glaucoma franchise driven by the initial commercial launch of iStent infinite. I'd like to congratulate the dedication and performance of our teams around the globe who remain committed to their work and to advancing our key initiatives.

好的。再次感謝，克里斯。大家下午好，感謝大家加入我們。今天，Glaukos 公佈第二季度綜合淨銷售額創歷史新高，達 8040 萬美元，比去年同期增長 11%。第二季度的業績反映了我們的國際青光眼和角膜健康特許經營業務創紀錄的銷售額和持續強勁的業績，同時我們的美國青光眼特許經營業務在 iStent 無限的首次商業推出的推動下重新出現增長。我要祝賀我們全球團隊的奉獻精神和表現，他們仍然致力於工作並推進我們的關鍵舉措。

Given our solid second quarter and our latest forward outlook, we are raising our 2023 net sales guidance range to $304 million to $308 million. Versus the $295 million to $300 million previously. From a commercial perspective, strong execution of key strategies within each of our core franchises drove our record quarter. Within our U.S. glaucoma franchise where we delivered sales of $39.6 million, which grew 4% year-over-year and 13% sequentially, we continue to advance iStent infinite ahead of establishing formal MAC coverage and payment.

鑑於第二季度的穩健表現和最新的前瞻性展望，我們將 2023 年淨銷售額指導範圍提高至 3.04 億美元至 3.08 億美元。與之前的 2.95 億至 3 億美元相比。從商業角度來看，我們每個核心特許經營權關鍵戰略的強有力執行推動了我們創紀錄的季度業績。在我們的美國青光眼專營權中，我們實現了 3960 萬美元的銷售額，同比增長 4%，環比增長 13%，在建立正式的 MAC 覆蓋和支付之前，我們繼續推進 iStent 無限。

On that front, 5 of the 7 MACs have issued proposed LCD reconsiderations that if finalized would provide coverage for iStent infinite, consistent with FDA approval and based upon our coverage reconsideration requests. In total, all 7 MACs have taken preliminary steps to assess iStent infinite coverage through either proposed LCDs or temporary LCA updates.

在這方面，7 個 MAC 中有 5 個已發布擬議的 LCD 重新考慮，如果最終確定，將為 iStent 無限提供承保，符合 FDA 的批准並基於我們的承保重新考慮請求。總的來說，所有 7 個 MAC 都已採取初步措施，通過提議的 LCD 或臨時 LCA 更新來評估 iStent 無限覆蓋範圍。

Further, we continue to support expanding broad access to interventional glaucoma tools for physicians and will closely monitor the various MAC policies and processes as they advance and are ultimately finalized in the future. We were also encouraged to see as part of the CMS 2024 proposed rule the CPT code used to cover iStent infinite and stand-alone procedures, 0671T has been lifted to APC 5492 from APC 5491. We are pleased with this initial proposal and believe, as we have stated in the past, that it more appropriately reflects the cost of infinite and similar stand-alone procedures.

此外，我們繼續支持擴大醫生對介入性青光眼工具的使用範圍，並將密切關注各種 MAC 政策和流程的進展並最終最終確定。我們還很高興地看到，作為 CMS 2024 提議規則的一部分，CPT 代碼用於涵蓋 iStent 無限和獨立程序，0671T 已從 APC 5491 提升到 APC 5492。我們對這一初步提議感到滿意，並相信，我們過去曾說過，它更恰當地反映了無限和類似的獨立程序的成本。

Separately, CMS also proposed to move the APC assignment for combined cataract plus trabecular bypass procedures 66989 and 66991 to a newly restructured APC 5493, which we also believe appropriately reflects the claims history as CMS stated in the proposed rule. If finalized, these changes will go into effect January 1, 2024.

另外，CMS 還建議將白內障聯合小梁繞道手術 66989 和 66991 的 APC 分配移至新重組的 APC 5493，我們也認為這適當地反映了 CMS 在擬議規則中所述的索賠歷史。如果最終確定，這些變更將於 2024 年 1 月 1 日生效。

As mentioned earlier, our international glaucoma franchise delivered record sales of $22.3 million on a strong broad based year-over-year growth of 25% on a reported basis and 27% on a constant currency basis.

如前所述，我們的國際青光眼特許經營業務實現了 2230 萬美元的創紀錄銷售額，按報告數據計算，同比增長 25%，按固定匯率計算，同比增長 27%。

As we continue to scale our international infrastructure, we are increasingly driving MIGS towards as a standard of care in each region and every major market in the world.

隨著我們不斷擴展我們的國際基礎設施，我們越來越多地推動 MIGS 成為世界上每個地區和每個主要市場的護理標準。

While we focus on our near-term execution, we are also accelerating efforts to support one of our founding missions at Glaukos, which is to advance glaucoma care by driving intervention of therapies earlier in the treatment paradigm for glaucoma disease and, in turn, pioneering a new stand-alone market over time. We continue to lead and work closely with surgeons and thought leaders globally to organically drive this broader evolution in the standard of care, including through numerous events at the ASCRS annual meeting in May and more recently at the World Glaucoma Society Biannual Meeting in Rome in June.

在我們專注於近期執行的同時，我們也在加緊努力，支持 Glaukos 的一項創始使命，即通過在青光眼疾病治療範式中推動早期治療干預來推進青光眼護理，進而開創先河隨著時間的推移，一個新的獨立市場。我們繼續領導並與全球外科醫生和思想領袖密切合作，有機地推動護理標準的更廣泛發展，包括通過 5 月 ASCRS 年會和最近 6 月在羅馬舉行的世界青光眼協會雙年會舉行的眾多活動。

And finally, our Corneal Health franchise delivered record sales of $18.5 million on a 11% year-over-year growth, including Photrexa record sales of $15.9 million on year-over-year growth of 18% as key strategic initiatives implemented throughout the past year continue to take hold in support of this important business.

最後，我們的角膜健康系列產品銷售額達到創紀錄的 1850 萬美元，同比增長 11%，其中 Photrexa 的銷售額達到創紀錄的 1590 萬美元，同比增長 18%，這是去年實施的關鍵戰略舉措繼續堅定支持這一重要業務。

Shifting gears to the development front. We continue to prudently invest in and successfully advance a robust pipeline of novel promising platform technologies that we believe have the ability to significantly expand our addressable markets and fundamentally transform our company over time.

轉向發展前沿。我們繼續謹慎投資並成功推進一系列強大的新型有前景的平台技術，我們相信這些技術能夠顯著擴大我們的潛在市場，並隨著時間的推移從根本上改變我們的公司。

During the second quarter, we announced FDA acceptance of the previously submitted NDA for iDose TR, marking another important step in bringing this game-changing therapy one step closer to patients. We continue to be encouraged as we work closely with the FDA and their ongoing review process as we progress towards the agency's established PDUFA goal date of December 22, 2023.

在第二季度，我們宣布 FDA 接受了之前提交的 iDose TR NDA，這標誌著使這種改變遊戲規則的療法更接近患者的又一個重要步驟。隨著我們與 FDA 密切合作及其正在進行的審查流程，我們繼續受到鼓舞，朝著該機構既定的 PDUFA 目標日期（2023 年 12 月 22 日）邁進。

Alongside this, our teams continue to make nice progress with the preparation and planning of the iDose commercial launch targeted for early next year, including a robust set of peer-reviewed literature expected to be published over the remainder of this year and into 2024.

除此之外，我們的團隊在明年初 iDose 商業發布的準備和規劃方面繼續取得良好進展，其中包括預計將在今年剩餘時間和 2024 年發布的一組可靠的同行評審文獻。

Turning to the Corneal Health pipeline. During the second quarter, we completed enrollment in the second Phase III confirmatory trial for Epioxa, our next-generation corneal cross-linking therapy for the treatment of Keratoconus. This expeditious enrollment completion, which occurred in less than 6 months from trial commencement earlier this year, is a testament to the favorable risk-benefit profile of this next-generation therapy as well as our team's hard work in bringing this important rare disease therapy, one step closer to patients suffering from keratoconus which is a sight threatening corneal disease.

轉向角膜健康管道。在第二季度，我們完成了 Epioxa 的第二項 III 期驗證性試驗的入組，Epioxa 是我們用於治療圓錐角膜的下一代角膜交聯療法。自今年早些時候試驗開始以來不到6 個月的時間就迅速完成了入組工作，證明了這種下一代療法的有利風險效益狀況，以及我們團隊為推出這種重要的罕見疾病療法所做的辛勤工作，距離圓錐角膜患者又近了一步，圓錐角膜是一種威脅視力的角膜疾病。

We look forward to following these patients outcomes as we target NDA submission for Epioxa by the end of 2024. As you can see, we have a lot to be excited about when it comes to the significant potential value that we believe our pipeline programs may create.

我們期待著跟踪這些患者的結果，因為我們的目標是在2024 年底之前提交Epioxa 的NDA。正如您所看到的，當談到我們相信我們的管道項目可能創造的巨大潛在價值時，我們有很多值得興奮的事情。

At the same time, as we discussed last quarter, we continue to prioritize the cadence of our investments as we strive to strike the right balance of risk-based investments and our capital position now and in the future.

與此同時，正如我們上季度討論的那樣，我們繼續優先考慮投資節奏，努力在基於風險的投資與現在和未來的資本狀況之間取得適當的平衡。

As evidence of that, our non-GAAP, SG&A and R&D operating expenses in the second quarter moderated to 6% year-over-year growth, reflecting some of the initial development adjustments we've made in our earlier-stage pipeline programs as we continue to prioritize our resources ahead of the anticipated iDose commercial launch early next year.

作為證據，我們第二季度的非 GAAP、SG&A 和研發運營費用同比增長放緩至 6%，反映了我們在早期管道項目中做出的一些初步開發調整，因為我們在預計明年初iDose 商業推出之前，繼續優先考慮我們的資源。

So in conclusion, I'm very pleased with the record quarter and building momentum in our business as we continue to successfully advance our mission to truly transform vision by pioneering novel, dropless platforms that can meaningfully advance the standard of care and improve outcomes for patients suffering from sight threatening chronic eye diseases.

總而言之，我對創紀錄的季度業績和業務發展勢頭感到非常滿意，我們將繼續成功推進我們的使命，通過開創新穎的無滴平台來真正改變視力，這些平台可以有意義地提高護理標準並改善患者的治療結果患有威脅視力的慢性眼病。

So with that, I'll open the call for questions. Operator?

因此，我將開始提問。操作員？

(Operator Instructions) Our first question will come from the line of Tom Stephan with Stifel.

（操作員說明）我們的第一個問題將來自 Tom Stephan 和 Stifel 的線路。

Great. First one, I'll start with iDose. I guess, big picture, in your guys' minds, what does the successful launch in 2024 look like? [DURYSTA], you hear different numbers. I think $50 million has been cited as a year 1 number. But even if it's run rating more in the $30 million to $40 million range. Is that a decent starting point or benchmark as we try to refine our models for year 1 iDose now that we're getting much closer to hitting the market. But just any guardrails for how to think about 2024 iDose would be very helpful.

偉大的。第一個，我將從 iDose 開始。我猜想，在你們心目中，2024 年成功發射會是什麼樣子？ [DURYSTA]，你聽到不同的數字。我認為 5000 萬美元已被列為第一年的數字。但即使它的運行評級在 3000 萬至 4000 萬美元範圍內。這是一個不錯的起點或基準，因為我們正在努力完善第一年 iDose 的模型，因為我們距離上市越來越近了。但任何關於如何思考 2024 年 iDose 的護欄都會非常有幫助。

Tom, it's Joe. I'll start, and Tom may want to add some color commentary at the end too. As we think about iDose, and obviously, I'm not going to comment on the specifics of the guardrails of any given number, how will we define success? I think we're going to define success in a couple of different ways.

湯姆，是喬。我會開始，湯姆也可能想在最後添加一些色彩評論。當我們考慮 iDose 時，顯然，我不會評論任何給定數字的具體細節，我們將如何定義成功？我認為我們將以幾種不同的方式來定義成功。

First, the more broad theme of continuing to drive the interventional glaucoma mindset and really the need and reason for intervening with these safe and minimally invasive technologies. But specific to the launch, you've been around the story long enough to know that our focus is on making sure that we deliver the right kind of training and the right kind of outcomes for surgeons out of the gate. So we're going to prioritize doing this the right way and doing it the right way, both from the surgeon's perspective as well as ultimately in achieving the optimal sort of reimbursement outcomes and everything else that go to drive long-term success over any particular quarter or target number for the year. Obviously, you know we're enthusiastic about what iDose means for our future, and we're going to make sure we put the right building blocks in place to achieve that success.

首先，更廣泛的主題是繼續推動介入性青光眼思維，以及使用這些安全和微創技術進行干預的真正必要性和理由。但具體到此次發布，您已經了解了這個故事足夠長的時間，知道我們的重點是確保我們為外科醫生提供正確的培訓和正確的結果。因此，我們將優先考慮以正確的方式做這件事，並以正確的方式做這件事，無論是從外科醫生的角度來看，還是最終實現最佳的報銷結果，以及推動長期成功的其他一切。季度或年度目標數。顯然，您知道我們對 iDose 對我們的未來意味著什麼充滿熱情，並且我們將確保我們建立正確的構建模塊以實現這一成功。

Got it. That's helpful. And then to pivot to infinite, maybe a 2-parter, but any trends you can speak of with Internet to date and maybe even into 3Q, just momentum with that product here in the U.S. Any color you can provide would be very helpful. And then in terms of the facility fee proposal, really encouraging to see I think, over a doubling of the ASC facility fee. Can you just talk about what that could mean in 2024 for the product? Maybe more specifically, do you think there's a good opportunity to take some price on that product?

知道了。這很有幫助。然後轉向無限，可能是 2 部分，但是迄今為止您可以談論的任何互聯網趨勢，甚至可能進入第三季度，只是該產品在美國的勢頭。您可以提供的任何顏色都會非常有幫助。然後就設施費提案而言，我認為 ASC 設施費翻倍確實令人鼓舞。您能談談這對 2024 年的產品意味著什麼嗎？也許更具體地說，您認為有一個很好的機會對該產品定價嗎？

Tom. So I think first, just in terms of the broader trends of iStent infinite, we continue to be really pleased with the momentum here, as we wind our way through the formal MAC and coverage process both within the Medicare side as well as the commercial payer side, to see the early utilization and adoption the way we've seen it is really particularly encouraging when you put it in the context of where we're at on the reimbursement side, which with -- as you know, 5 of the 7 MACs having proposed draft LCDs for coverage that's largely aligned with our formal coverage request and the product label and the other 2 having addressed via local coverage articles or LCAs.

湯姆.因此，我認為首先，就 iStent 無限的更廣泛趨勢而言，我們仍然對這裡的勢頭感到非常滿意，因為我們在醫療保險方面以及商業付款人方面都在正式的 MAC 和承保流程中取得了進展方面，當你把它放在報銷方面的背景下時，以我們所看到的方式看到早期利用和採用確實特別令人鼓舞，正如你所知，7 中的 5 MAC 已提出了覆蓋範圍的LCD草案，該草案在很大程度上與我們的正式覆蓋要求和產品標籤一致，其他兩個已通過本地覆蓋文章或LCA 進行了解決。

We're making our way through that process. But it's still early. And so the momentum we're seeing around iStent infinite and its utilization speaks a lot to the potential need for a product like this in the marketplace. Even though we're still working our way through the formalities of achieving proper coverage from the various MACs and commercial payers for that matter.

我們正在努力完成這個過程。但現在還早。因此，我們看到 iStent 無限的勢頭及其使用充分說明了市場對此類產品的潛在需求。儘管我們仍在努力辦理相關手續，以獲得各個 MAC 和商業付款人的適當承保。

I think as it relates to the facility fee in 2024, you heard Tom reference in the prepared remarks that we're obviously pleased to see the proposed rule as it relates to the facility fee for infinite and combo cataract for that matter. And you know, it's pretty consistent with what we've said historically, we would expect given on the data that we see. But sometimes it takes some time to work through the process. And so to be here with the proposed rule, we're obviously pleased in what that means for 2024.

我認為，由於它與 2024 年的設施費有關，您聽到 Tom 在準備好的發言中提到，我們顯然很高興看到擬議的規則，因為它與無限和組合白內障的設施費有關。你知道，這與我們歷史上所說的非常一致，我們根據所看到的數據所期望的。但有時需要一些時間來完成該過程。因此，來到這裡提出擬議的規則，我們顯然對這對 2024 年意味著什麼感到高興。

As you know, pricing, and it really gets (inaudible) second question, pricing of product is -- it's multifactorial in terms of product attributes, your overall portfolio, competition and yes, reimbursement. And so what I can say is that I think the proposed changes, if they're finalized, will thankfully enable facilities to do these site-saving procedures to receive appropriate reimbursement that makes the procedure economically feasible for them. And I think patients end up benefiting at the end of that.

正如你所知，定價，它確實得到了（聽不清）第二個問題，產品的定價是——它在產品屬性、你的整體產品組合、競爭以及報銷方面是多因素的。因此，我可以說的是，我認為擬議的變更如果最終確定，將幸運地使設施能夠執行這些節省場地的程序，以獲得適當的報銷，從而使該程序在經濟上對他們來說是可行的。我認為患者最終會受益。

Your next question will come from the line of Ryan Zimmerman with BTIG.

您的下一個問題將來自 BTIG 的 Ryan Zimmerman。

And nice results here. I guess I want to ask first on guidance. If you look at kind of where the guidance is going based on results, and Joe, you know where I'm going with this question, it implies as kind of a step down on an absolute dollar basis in the back half of the year, relative to what is historically a strong seasonal fourth quarter. So -- any color here on kind of your thought process?

這裡的結果很好。我想我想先詢問指導。如果你看看基於結果的指導方針，喬，你知道我對這個問題的看法，這意味著下半年絕對美元基礎上的下降，相對於歷史上強勁的季節性第四季度。那麼——你的思維過程有什麼顏色嗎？

And the second part of the question is just what impact from the proposed LCD and the other 2 MACs, have you seen in numbers in this quarter -- in the second quarter? And kind of what effect has that had kind of on physician behavior? And then I have a follow-up.

問題的第二部分是，您在本季度（第二季度）的數字中看到了擬議的 LCD 和其他 2 個 MAC 的影響嗎？這對醫生的行為有何影響？然後我有一個後續行動。

Sure, Ryan. -- obviously expected it in that context. I think -- well, let me start first. Obviously, it was a high-quality first half and the second quarter from an execution standpoint, it exceeded our expectations across the board. When you think about 2023, for us, it really remains all about building the strongest foundation possible ahead of what we think will be a pretty transformational period for our company going forward with infinite, iDose and Epioxa.

當然，瑞安。 ——顯然是在這種情況下預料到的。我想——好吧，讓我先開始吧。顯然，從執行的角度來看，上半年和第二季度都是高質量的，全面超出了我們的預期。當你想到 2023 年時，對我們來說，實際上仍然是在我們認為公司將迎來一個相當大的轉型時期之前建立最強大的基礎，並推出Infinite、iDose 和 Epioxa。

So we had a good start in the first half, but we have a lot of work in front of us as we continue to lay that foundation. I think at the outset of the year, we were pretty clear we wanted to walk before we ran, as it related to guidance. And I think the update we're giving here today probably reflects of us starting to jog and use the same analogy. What have we tried to reflect and what's included in that. I'll try to give a little bit of color here.

因此，我們在上半場取得了良好的開局，但在我們繼續奠定基礎的過程中，我們還有很多工作要做。我認為在今年年初，我們很清楚我們想在跑步之前走路，因為這與指導有關。我認為我們今天在這裡給出的更新可能反映了我們開始慢跑並使用相同的類比。我們試圖反映什麼以及其中包含什麼。我將嘗試在這裡提供一點顏色。

We've tried to reflect, obviously, the encouraging first half trends that you pointed to and what that can mean. We've also tried to factor in the fact that from -- as we look across the landscape and you all see this even more than we do, that health care procedure trends broadly feel pretty healthy and maybe even a bit elevated in the first half as some of the staffing constraints that have been an issue in 2022, started to ease a bit, and that enabled accounts to work through their backlog.

顯然，我們試圖反映您指出的令人鼓舞的上半年趨勢以及這可能意味著什麼。我們還試圖考慮到這樣一個事實：當我們縱觀全局時，你們都比我們更清楚地看到這一點，醫療保健程序的趨勢總體上感覺相當健康，甚至可能在上半年有所上升。 2022 年，一些一直存在的人員配置限制開始有所緩解，這使得賬戶能夠處理積壓的訂單。

So our guidance that we reported for today assumes more of a normalization of that reality in the second half. It also assumes that we've really not included any material benefit from the finalized LCDs in 2023, particularly as it relates to iStent infinite. And this ties a little bit into the second part of your question, which I'll get to in a second. But what we've really assumed is that we remain in a steady state -- we can talk about it more in the context of the LCD process, but there's no certainty in terms of exactly when those will be finalized.

因此，我們今天報告的指導意見更多地假設下半年這一現實將正常化。它還假設我們確實沒有從 2023 年最終確定的 LCD 中獲得任何實質性好處，特別是與 iStent 無限相關的好處。這與你問題的第二部分有些聯繫，我稍後會談到。但我們真正假設的是我們保持在穩定狀態——我們可以在 LCD 工藝的背景下更多地討論它，但具體何時最終確定還不確定。

And once we know that, we can obviously better quantify the potential impact that has, especially to iStent infinite. We have to factor in the summer seasonality, which we would we do in globally in Q3 in particular. And that's been more pronounced in recent years coming out of COVID.

一旦我們知道了這一點，我們顯然可以更好地量化其潛在影響，尤其是對 iStent 無限的影響。我們必須考慮夏季季節性因素，特別是在第三季度我們將在全球範圍內考慮這一點。近年來，這種情況在新冠疫情中表現得更加明顯。

And then the ongoing competitive dynamics, including from Alcon as well as some of the more invasive [glaucoma] procedures. And that really ties into your -- the second part of your question. I think the LCDs as proposed I wouldn't say we've seen much of an impact at all from those in the context of what's happening here and now in the marketplace. They're proposed. They haven't changed any of the coverage rules for these products. And so until they do, I would expect that surgeons largely continue to operate as they have been on the basis of the reimbursement and the coverage that exists today.

然後是持續的競爭動態，包括來自愛爾康的競爭以及一些更具侵入性的[青光眼]手術。這確實與你問題的第二部分有關。我認為，就目前市場上正在發生的情況而言，我不會說我們已經看到液晶顯示器產生了多大影響。他們是被提議的。他們沒有改變這些產品的任何承保規則。因此，在他們這樣做之前，我預計外科醫生基本上會繼續按照目前的報銷和承保範圍進行手術。

Okay. Very thorough on that. I want to squeeze in one more. Just, Tom, you talked about moderating spending, and I thought that was an interesting comment given kind of we're about to prepare for what is arguably one of the biggest products in the company's history and a launch around that. And so I think the earlier question kind of talked about what is a successful launch. But maybe on the other side of the P&L, I mean what is moderating spending mean in terms of how you go to market and sell iDose from a commercial standpoint?

好的。對此非常徹底。我還想再擠一張只是，湯姆，你談到了節制支出，我認為這是一個有趣的評論，因為我們即將為可以說是公司歷史上最大的產品之一以及圍繞該產品的推出做準備。所以我認為之前的問題有點談論什麼是成功的發布。但也許在損益表的另一面，我的意思是，從商業角度來看，就如何進入市場和銷售 iDose 而言，節制支出意味著什麼？

Yes. Great question. Happy to answer it, Ryan. So when I talk about moderating, we're talking about an extensive array of organic development programs that we've been really blessed to have in the organization as we're carrying these forward.

是的。很好的問題。很高興回答這個問題，瑞安。因此，當我談論審核時，我們談論的是一系列廣泛的有機發展計劃，在我們推進這些計劃的過程中，我們非常幸運能夠在組織中擁有這些計劃。

And so that obligates me and compels me to prioritize and use our capital in the best way to establish benefit to risk and optimal return on investment for shareholders. And so that's what we're doing. So I wouldn't be -- draw the wrong conclusions. I would tell you that we have tremendous capital that we'll employ towards the significantly successful of our target launch of iDose. That is a question of timing.

因此，這迫使我優先考慮並以最佳方式使用我們的資本，為股東建立風險效益和最佳投資回報。這就是我們正在做的事情。所以我不會——得出錯誤的結論。我想告訴您，我們擁有巨大的資本，我們將利用這些資本來實現 iDose 的上市目標取得巨大成功。這是一個時間問題。

I expect some of that to occur later this year and on into 2024. And so we understand the order of magnitude that this launch could mean for the company. And so I can assure you that we'll make the necessary capital -- put the necessary capital behind this launch to make it a success.

我預計其中一些將在今年晚些時候和 2024 年發生。因此我們了解這次發布對公司可能意味著什麼。因此，我可以向你們保證，我們將籌集必要的資金——為這次發布提供必要的資金，以使其取得成功。

Your next question comes from the line of Larry Biegelsen with Wells Fargo.

您的下一個問題來自富國銀行的拉里·比格爾森 (Larry Biegelsen)。

This is Charles on for Larry. First congrats on the nice quarter. First question, a quick follow-up on guidance. I wonder if you could give a little thoughts on quarterly cadence of sales through the back half of 2023. I know you mentioned -- you mentioned a little summer seasonality. So I don't know if that's implying that Q3 a little lower in Q4 is a bit of a step-up, but maybe some thoughts on that. And then I have a quick follow-up on iDose.

這是查爾斯替補拉里。首先祝賀這個美好的季度。第一個問題，快速跟進指導。我想知道您是否可以對 2023 年下半年的季度銷售節奏進行一些思考。我知道您提到過 — 您提到了一點夏季季節性因素。所以我不知道這是否意味著第三季度比第四季度低一點是一個進步，但也許對此有一些想法。然後我對 iDose 進行了快速跟進。

Yes, Charles, I think that's -- you hit it with really the way you asked the question. If you look -- implied guidance is the second half looks somewhat like the first half. And that the -- I think the summer seasonality dynamic that we've seen in recent years plays itself out here in the third quarter. The last month of the quarter tends to drive a lot as people return back to doing procedures in a fulsome way on a global basis. So we'll see how that plays out. But at this point, yes, I would expect that Q3 sees a bit of a downtick from that summer seasonality, and then that recovers in Q4.

是的，查爾斯，我認為——你問問題的方式確實擊中了問題。如果你看一下——隱含的指導是下半場看起來有點像上半場。我認為近年來我們看到的夏季季節性動態在第三季度顯現出來。隨著人們在全球範圍內以充實的方式恢復辦理手續，本季度的最後一個月往往會帶來很大的推動力。所以我們將看看結果如何。但在這一點上，是的，我預計第三季度會比夏季季節性有所下降，然後在第四季度恢復。

Great. And then -- and then a follow-up on iDose. So do you still expect no restrictions on the repeat procedures upon approval? And then also, you said you plan to work towards reimbursement for iDose in the office setting. How might -- how long do you think that could take after launch? And do you think that's a big catalyst for adoption?

偉大的。然後——然後是 iDose 的後續行動。那麼您還期望審批後不再限制重複程序嗎？此外，您還表示您計劃努力實現辦公室環境中 iDose 的報銷。您認為發射後可能需要多長時間？您認為這是採用的重要催化劑嗎？

Yes, Charles, I'll be happy to take those. So your first question was on whether or not we expect to be restricted at all in exchange. And so we've answered this before and continue to express confidence that, that won't be an imposition for us. And if you recall, our exchange study that we did by reconsenting patients in the Phase IIb study, we had 33 patients that we were following over 5 years and we saw no real substantive differences between treatment and control.

是的，查爾斯，我很樂意接受這些。所以你的第一個問題是我們是否希望作為交換而受到限制。因此，我們之前已經回答過這個問題，並繼續表示相信，這對我們來說不會是一種強加。如果您還記得，我們通過在 IIb 期研究中重新同意患者進行的交換研究，我們對 33 名患者進行了超過 5 年的跟踪，我們發現治療和對照之間沒有真正的實質性差異。

And so we feel confident that we will not have a restriction going into that study. Now with regards to how we will go to launch, again, it's important that we take this in a twofold way. One, I want to provide site of surface offerings or surgeons to be able to do the iDose both in the office and certainly in the ASC.

因此，我們有信心這項研究不會受到限制。現在，關於我們將如何啟動，再次強調，重要的是我們要以雙重方式對待它。第一，我想提供表面產品或外科醫生的網站，以便能夠在辦公室和當然在 ASC 中進行 iDose。

Recall that as we get to launch, we will be approaching MACs to establish an appropriate professional fee. They'll be an assignment to an APC. That will then be -- typically, we'll see that over the first half of the year.

回想一下，當我們啟動時，我們將與 MAC 聯繫以確定適當的專業費用。他們將被分配給裝甲運兵車。通常情況下，我們會在今年上半年看到這一點。

On the drug payment side, you'll recall, we'll have a miscellaneous J-code at launch. And we'll file for a HCPCS code which in my experience and others, typically takes 2 quarters to be able to get a former J-code.

您還記得，在藥品支付方面，我們將在發佈時提供各種 J 代碼。我們將申請 HCPCS 代碼，根據我和其他人的經驗，通常需要 2 個季度才能獲得以前的 J 代碼。

That J code will apply to both ASCs and to in offices. And so when we talk about in-office use, which we believe will become an important part of the use of iDose over time. What we'll need to do is to establish non-facility payment. And that's done by approaching the MACs individually. We will need to get society -- specialty society support and KOLs. And what we'll do is we'll develop a practice expense work up which will be the basis for which these MACs will be able to consider, what the professional fee will be for non-facility payment in office.

該 J 代碼將適用於 ASC 和辦公室。因此，當我們談論辦公室內使用時，我們相信隨著時間的推移，這將成為 iDose 使用的重要組成部分。我們需要做的是建立非設施支付。這是通過單獨接觸 MAC 來完成的。我們需要獲得社會——專業社會的支持和 KOL。我們要做的是製定一項實踐費用工作表，這將成為這些 MAC 能夠考慮辦公室非設施付款的專業費用的基礎。

And as you recall, typically, that professional fee payment is higher in the non-facility because there is no -- in the non-facility because there is no facility payment. So the professional fee, we expect will exceed the professional fee on the ASC side.

正如您所記得的那樣，通常情況下，非設施中的專業費用支付較高，因為在非設施中沒有設施付款，因為沒有設施付款。因此，我們預計專業費用將超過 ASC 方面的專業費用。

This is something that happens fairly. It happens case-by-case as we go forward with the MACs. So it will be something that will occur over time. But as I've said now, probably since we've had our IPO, this will be an important component longer term. To give the physicians the ability to use in office as a site of service for what we believe will be a game-changing technology.

這是公平發生的事情。當我們繼續使用 MAC 時，這種情況會逐案發生。所以這將是隨著時間的推移而發生的事情。但正如我現在所說的，可能自從我們進行首次公開​​募股以來，這將是長期的一個重要組成部分。讓醫生能夠在辦公室使用我們相信將改變遊戲規則的技術作為服務場所。

Your next question comes from the line of George Sellers with Stephens.

你的下一個問題來自喬治·塞勒斯和斯蒂芬斯的對話。

Congrats on a great quarter. Sticking with iDose. You've obviously had some success with iStent infinite adoption despite working through some of the reimbursement processes with the MACs. But I'm just curious, as it relates to iDose, is there anything we can kind of take from that commercialization of iStent infinite and apply to the expected commercialization of iDose?

恭喜您度過了一個出色的季度。堅持使用 iDose。儘管與 MAC 一起完成了一些報銷流程，但顯然您在無限採用 iStent 方面取得了一些成功。但我只是很好奇，因為它與 iDose 相關，我們是否可以從 iStent 無限的商業化中獲得任何東西並應用於 iDose 的預期商業化？

And I know we're still waiting on approval and it's a little bit more complicated than infinite in a lot of ways. But what could demand for iDose look like prior to reimbursement fully coming together? And how do you expect that to sort of progress.

我知道我們仍在等待批准，而且在很多方面它都比無限複雜一點。但在報銷完全到位之前，對 iDose 的需求會是什麼樣子呢？您期望這方面的進展如何？

Yes. I mean I think it's hard to draw a direct line between the experience with one product versus the next, given they have different labels and different indications and different patient populations that they're targeting. I think the thing that you can't take from infinite is our commitment to doing it the right way, to being methodical in the way we launch these products and the way that we train our surgeons and the way that we make our way through the reimbursement process.

是的。我的意思是，我認為很難在一種產品的體驗與另一種產品的體驗之間劃清界限，因為它們有不同的標籤、不同的適應症以及他們所針對的不同患者群體。我認為你不能從無限中得到的東西是我們對以正確的方式做事的承諾，以有條不紊的方式推出這些產品，我們培訓外科醫生的方式，以及我們通過的方式。報銷流程。

Over a couple of decades, we've earned a lot of experience in going through this process of launching new products into white spaces. And I think iDose, in some respects will be another example of that as we go forward. I think we -- there's enough variables in play there that we'll address what we expect for 2024, for example, when we get to our guidance for that year versus getting ahead of that now at this point.

幾十年來，我們在向空白市場推出新產品的過程中積累了豐富的經驗。我認為 iDose 在某些方面將成為我們前進的另一個例子。我認為，那裡有足夠多的變量，我們將解決我們對 2024 年的預期，例如，當我們達到那一年的指導時，而不是現在就超越這一點。

Okay. That makes sense. Maybe switching gears a little bit. You also recently announced an agreement with Radius XR. And I'm just curious if you could give some additional details on that deal. Any incremental costs you're expecting this year associated with that? And then also maybe what's assumed from that in the current guidance?

好的。這就說得通了。也許稍微改變一下方式。您最近還宣布與 Radius XR 達成協議。我只是好奇你能否提供有關該交易的一些額外細節。您預計今年會增加與此相關的成本嗎？那麼當前指南中的假設可能是什麼？

Yes. So I'll start in reverse order. I think from an expense standpoint, it's pretty immaterial. I wouldn't call anything out -- and from a guidance perspective, yes, it's factored in there. I wouldn't call that as a particular material driver of the guidance at this stage. But what really is behind Radius and why we're doing it is we've talked about some time about our role in pioneering these markets and growing the market.

是的。所以我將從相反的順序開始。我認為從費用的角度來看，這並不重要。我不會指出任何事情——從指導的角度來看，是的，它已被考慮在內。我不會將其稱為現階段指導的特定物質驅動因素。但 Radius 背後的真正原因以及我們這樣做的原因是，我們已經討論了一段時間我們在開拓這些市場和發展市場方面所扮演的角色。

And part of that is trying to make sure that we're helping to democratize testing and screening in a way that identifies these patients and helps them wherever they're first presenting themselves from a site of service standpoint. Whether it be an optometrist, whether it be retail optometrist like a Walmart optical or ultimately, obviously, in the MD setting.

其中一部分是努力確保我們正在幫助實現檢測和篩查的民主化，以識別這些患者的方式，並在他們第一次從服務站點的角度出現時為他們提供幫助。無論是驗光師，還是像沃爾瑪眼鏡店這樣的零售驗光師，或者最終，顯然，是MD環境中的驗光師。

That they're getting access to technology that can efficiently and easily test them for these sight threatening diseases and hopefully identifying them more early and getting them the kind of care that they need and deserve sooner or rather than later.

他們正在獲得能夠有效、輕鬆地測試他們是否患有這些威脅視力的疾病的技術，並希望更早地識別出這些疾病，並儘快為他們提供他們需要和應得的護理。

Today, as it stands, as you know, in many of these optometry centers, in particular, alongside of even some most, they're limited in terms of the diagnostic capabilities or when and where they actually deploy the diagnostic technology they have, to really test these patients. And so our hope is that by putting some incremental muscle behind the technology that we think is truly best-in-class and Radius that we can help democratize and really drive that screening and diagnostic side of the equation.

如今，正如您所知，在許多驗光中心中，特別是在大多數驗光中心中，它們的診斷能力或實際部署其所擁有的診斷技術的時間和地點都受到限制，真正考驗這些病人。因此，我們希望通過在我們認為真正一流的技術和 Radius 背後投入一些增量力量，我們可以幫助民主化並真正推動篩查和診斷方面的發展。

Your next question comes from the line of Joanne Wuensch with Citi.

您的下一個問題來自花旗銀行的 Joanne Wuensch。

I'm curious about 2 things. One is, at what stage are you comfortable sharing with us what the ASP is for iDose because we've heard a number of different numbers tossed around. And then the second question I have is your OUS mix is really strong. And I'm curious whether or not there is pent-up demand or a new region you opened up, any stocking? And would you be surprised if this didn't continue for the remainder of the year?

我對兩件事很好奇。一是，您在哪個階段願意與我們分享 iDose 的 ASP 是多少，因為我們已經聽到了許多不同的數字。我的第二個問題是你們的 OUS 組合非常強大。我很好奇是否有被壓抑的需求或者你們開闢了新的地區，有備貨嗎？如果這種情況在今年剩餘時間內沒有持續下去，您會感到驚訝嗎？

Thanks, Joanne. I'll take the first part of the question. So with regards to iDose pricing, we are still contemplating what that price will be. And -- and as I've said all along, we are being highly contemplative. We're looking at Markov transition probability analysis, burden of illness analysis. I'm factoring in what derisk the charge over $2,000 in a J code for 4 months of therapy.

謝謝，喬安妮。我將回答問題的第一部分。因此，關於 iDose 的定價，我們仍在考慮該價格是多少。而且——正如我一直以來所說的，我們正在高度沉思。我們正在研究馬爾可夫轉移概率分析，疾病負擔分析。我正在考慮 J 代碼中 4 個月治療費用超過 2,000 美元的風險因素。

And I'm also looking at surgical pharmaceuticals, both on the anterior segment side and on the retinal side, which I think will guide me in the basis for what I think will be a fair and compelling price. I would expect you not to hear that price until we are FDA approved. And so we'll be contemplating that. We'll take our time. We'll make sure we get it right and then some short time after FDA approval, you will hear and we'll disclose the pricing for iDose.

我還在研究眼前節側和視網膜側的外科藥物，我認為這將指導我確定一個公平且令人信服的價格。我希望在我們獲得 FDA 批准之前您不會聽到這個價格。所以我們會考慮這一點。我們會慢慢來。我們將確保我們做得正確，然後在 FDA 批准後不久，您就會聽到，我們將披露 iDose 的定價。

And on the international side, it really was another standout record quarter, 27% constant currency growth year-over-year (inaudible) I think, sequentially. It was broad based, (inaudible), across all of our regions and really, I think, reflects that strong execution by our teams globally. If you think about it, we're really pioneering a change in standard of care in each of these markets, just like we've been doing in the U.S. for some time.

在國際方面，這確實是另一個出色的創紀錄季度，我認為，貨幣同比增長率為 27%（聽不清）。它在我們所有地區都有廣泛的基礎（聽不清），我認為，這確實反映了我們全球團隊的強大執行力。如果你仔細想想，我們確實在這些市場中率先改變了護理標準，就像我們一段時間以來在美國所做的那樣。

And all of the various markets that we're in today are in a little bit different stage of that. And -- and all the things that you know we've done here to build the MIGS marketplace exist today in terms of the broader support, both from the community, the surgical treatment algorithms, the reimbursement dynamics in each of these -- all these markets are in a little different place. And so we're still making our way through really building and in virtually all of the markets we're in, we're still very much in the growth phase of that business.

我們今天所處的所有不同市場都處於稍微不同的階段。而且 - 你知道我們在這里為建立 MIGS 市場所做的所有事情今天都存在於更廣泛的支持方面，包括來自社區、手術治療算法、每個方面的報銷動態 - 所有這些市場的情況略有不同。因此，我們仍在真正建設中，在我們所處的幾乎所有市場中，我們仍處於該業務的增長階段。

We didn't add any new regions or any unique drivers here. I think probably at the beginning of 2022 from a growth standpoint, there was still a little bit of lag effect, a couple of the regions still felt a little touch of COVID. They probably had those numbers a little depressed on a year-over-year growth standpoint.

我們沒有在這裡添加任何新區域或任何獨特的驅動程序。我認為從增長的角度來看，可能在 2022 年初，仍然存在一點滯後效應，一些地區仍然感受到了一點新冠疫情的影響。從同比增長的角度來看，他們的這些數字可能有點低迷。

But all in all, we couldn't be more pleased with the execution of the team. I do expect that similar to what we talked about in terms of macro guidance, you'll probably see a little bit more normalization. I think the same dynamics that have been playing true here in the U.S. from a staffing levels and getting back to business as normal and clearing some of the backlog, inherent our guidance is that we'll see a little bit of normalization there in the second half, not just in the U.S. but globally. So we would expect that business from a growth perspective would come in a bit in the second half relative to what we've experienced thus far in the first.

但總而言之，我們對團隊的執行力感到非常滿意。我確實預計，與我們在宏觀指導方面討論的類似，您可能會看到更多的正常化。我認為，在美國，從人員配置水平到恢復正常業務以及清理一些積壓訂單，我們的指導方針是，我們將在第二季度看到一些正常化。一半，不僅在美國，而且在全球範圍內。因此，我們預計，從增長的角度來看，下半年的業務將比上半年的情況有所改善。

Your next question will come from the line of Matt O'Brien with Piper Sandler.

你的下一個問題將來自馬特·奧布萊恩和派珀·桑德勒的對話。

This is Phil on for Matt. Thanks for squeezing us in at the end and congrats on another great quarter. Just for starters been I don't want to belabor the point here, but laying the groundwork for an early 2024 launch of iDose, how are those conversations with docs going as far as using the currently available miscellaneous J code? And what I'm really trying to get at is, that requires that process. So are docs aware of how that process works and what might early utilization look like there?

這是菲爾替馬特發言。感謝您最後讓我們加入，並祝賀又一個偉大的季度。首先，我不想在這裡過多闡述這一點，但為了為 2024 年初推出 iDose 奠定基礎，與文檔的對話在使用當前可用的各種 J 代碼方面進展如何？我真正想要表達的是，這需要這個過程。那麼文檔是否知道該過程是如何工作的以及早期利用會是什麼樣子？

Sure, Phil. I think a couple of things first. You can imagine that given iDose has not yet received approval, there really aren't conversations specific to iDose, as it relates to reimbursement and how the dynamics with miscellaneous codes and all those various things go specific to the product.

當然，菲爾。我首先想到幾件事。您可以想像，鑑於 iDose 尚未獲得批准，實際上沒有專門針對 iDose 的對話，因為它涉及報銷以及各種代碼的動態以及所有這些不同的事物如何特定於產品。

The vast majority of our customers have been through this before in some capacity. Some are better at that process than others. All I can tell you is that we're very prepared for that part of the launch and educating our customers as we go through that, getting them comfortable with how that will work.

我們的絕大多數客戶以前都以某種身份經歷過這種情況。有些人比其他人更擅長這個過程。我能告訴你的是，我們已經為發布的這一部分做好了充分的準備，並在整個過程中對我們的客戶進行教育，讓他們熟悉它的運作方式。

Ultimately, as you can expect, many of them will want to see it and see themselves do it successfully. So I -- we do expect that they themselves will walk a bit before they run as I like to say. But it's something we're prepared to take care of and educate at launch on a customer-by-customer basis. But getting ahead of it in their knowledge today is more based upon their broader experience in the industry than it is specific to iDose.

最終，正如你所期望的，他們中的許多人會希望看到它並看到自己成功地做到這一點。所以我——我們確實希望他們自己在跑步之前先走一會兒，就像我想說的那樣。但我們準備在發佈時針對每個客戶進行處理和教育。但今天他們在知識方面的領先更多地是基於他們在行業中更廣泛的經驗，而不是 iDose 特有的。

That's helpful. And then just one follow-up on R&D. I noticed -- and I know you called out some initial development adjustments in some earlier-stage pipeline programs. And I don't think I heard anything specifically called out there. I just wanted to check if there was any impact to iDose TREX.

這很有幫助。然後是研發方面的一項後續行動。我注意到——我知道你在一些早期階段的管道項目中提出了一些初步的開發調整。我想我沒有聽到任何特別的聲音。我只是想檢查一下 iDose TREX 是否有任何影響。

Phil, this is Alex. I'll just kind of comment on that. And it goes kind of what Tom was earlier speaking about, which is we have sat down as we looked at our capital position, we looked at our pipeline, we looked at iDose launch and what we needed to invest in for that activity. And so we've started to make decisions around allocating those resources appropriately, in order to really fulsomely prepare for and invest in the iDose launch that's coming up. I don't think we've gotten much more granular than that.

菲爾，這是亞歷克斯。我只是對此發表評論。這有點像湯姆早些時候所說的，我們坐下來審視我們的資本狀況，我們審視我們的管道，我們審視 iDose 的推出以及我們需要為該活動投資什麼。因此，我們已經開始做出適當分配這些資源的決策，以便為即將推出的 iDose 做好充分的準備和投資。我認為我們沒有比這更細緻了。

Yes. I don't think we've said anything specific to any individual programs. But you can imagine that the iDose franchise remains a top priority for us, not just the first generation, but I heard you reference TREX and sort of the extended release portion of that, and we continue to move forward full steam ahead on that front.

是的。我認為我們沒有針對任何單獨的計劃說過任何具體的話。但你可以想像，iDose 特許經營權仍然是我們的首要任務，而不僅僅是第一代，但我聽說你提到了 TREX 以及其中的延長發布部分，我們將繼續在這方面全速前進。

Your next question comes from the line of David Saxon with Needham.

你的下一個問題來自大衛·撒克遜與李約瑟的對話。

This is Joseph on for David. Maybe one on iStent. In terms of adoption for iStent infinite, are you seeing a traction from new docs to Glaukos? Or is the adoption primarily centered around current iStent inject users?

這是大衛的約瑟夫。也許是 iStent 上的一個。就 iStent 無限的採用而言，您是否看到新文檔對 Glaukos 的吸引力？或者採用主要集中在當前的 iStent 注射用戶？

Yes, Joseph, I think you're always going to see a little bit of that, but you got to put it in the context of the stage of where we're at. I think at this stage, the majority, if not the vast majority of that adoption, utilization, expansion, the stand-alone utilization, et cetera, is happening within customers that have been Glaukos customers for some time.

是的，約瑟夫，我想你總會看到一些這樣的情況，但你必須把它放在我們所處階段的背景下。我認為在現階段，大多數（如果不是絕大多數）採用、利用、擴展、獨立利用等都發生在已經成為 Glaukos 一段時間客戶的客戶中。

That tends to be how you launch these things anyway, and I think it's true with iStent infinite. Now as we continue to move forward and establish reimbursement coverage, we certainly hope that it will expand more, particularly in the glaucoma community where this product should be well received.

無論如何，這往往就是你啟動這些東西的方式，我認為 iStent 無限也是如此。現在，隨著我們繼續前進並建立報銷範圍，我們當然希望它能夠擴大更多，特別是在青光眼社區，該產品應該受到好評。

And for folks who made today, they spend their time a little bit more in the late-stage procedures -- tubes and trabs and other devices that work at that stage, you hope that, obviously, they'll start to adopt iStent infinite as the coverage really picks up on the reimbursement side and they're able to run free.

對於今天所做的人來說，他們在後期手術中花費了更多的時間 - 管子和導管以及其他在該階段工作的設備，顯然，你希望他們會開始採用 iStent 無限作為報銷方面的承保範圍確實有所增加，而且他們可以自由奔跑。

Fair enough. Makes sense. Maybe a bigger picture question. With the products you have approved today, what would you kind of say your long-term growth profile is? What do you think the glaucoma business can grow longer term? You talked about Corneal Health growing 8% to 12%. Is that still kind of your thinking or -- as reimbursement starts to get more specific, could there be upside to that?

很公平。說得通。也許是一個更大的問題。對於您今天批准的產品，您認為您的長期增長概況是什麼？您認為青光眼業務可以長期增長嗎？您談到角膜健康增長 8% 至 12%。這仍然是你的想法嗎？或者——隨著報銷開始變得更加具體，這可能有好處嗎？

Well, I think there's a couple of different parts that within your question, specifically to the Corneal Health business, I think we continue to think about that at the moment, a high single-digit type growth franchise. We're encouraged by what we've seen so far in the first half. We'll need to see a little bit more from that business before we upgrade that, if you will, in terms of our growth expectations.

嗯，我認為你的問題中有幾個不同的部分，特別是角膜健康業務，我認為我們目前仍在考慮這個高個位數增長的特許經營權。我們對上半年迄今為止所看到的情況感到鼓舞。如果您願意的話，就我們的增長預期而言，在我們升級該業務之前，我們需要對該業務進行更多了解。

But I think more importantly, the macro question that you're asking to me, it's hard at our stage to put a number out there and say we think we can grow at. The reality is that we've been operating in both sides of our business, U.S. glaucoma and Corneal Health and for that matter, international glaucoma, inside of still relatively small markets versus what we're about to start embarking on.

但我認為更重要的是，你向我提出的宏觀問題是，在我們這個階段很難給出一個數字並說我們認為我們可以成長。現實情況是，我們一直在美國青光眼和角膜健康業務以及國際青光眼業務方面開展業務，與我們即將開始的市場相比，這些市場仍然相對較小。

When you think about the size of the combo cataract opportunity, relative to what we can potentially achieve as we drive the interventional glaucoma change in standard of care, if you will, and the sheer number of patients who can benefit from that mindset relative to the combo cataract setting, I think we're very -- it's why we're very excited about what this next chapter means for Glaukos and where we're going to go.

當您考慮組合白內障機會的大小時，相對於我們在推動介入性青光眼治療標準的變化時可能實現的目標（如果您願意的話），以及可以從這種心態中受益的患者數量相對於組合白內障設置，我認為我們非常- 這就是為什麼我們對下一章對Glaukos 意味著什麼以及我們要去的地方感到非常興奮。

And I think in a similar fashion, Epioxa represents that same type of transformational moment, if you will, for us on the cornea side as we get closer and closer to hopefully that approval and launch. So we have a lot of reason for optimism about what that long-term growth trajectory looks like. We're swimming in a much larger and deeper ocean as we move forward here. And I think that's going to hopefully benefit us and you all shareholders.

我認為，以類似的方式，Epioxa 代表著同樣類型的轉型時刻，如果你願意的話，對於我們角膜方面來說，隨著我們越來越接近希望獲得批准和發布。因此，我們有很多理由對長期增長軌跡持樂觀態度。當我們在這裡前進時，我們正在更大更深的海洋中游泳。我認為這有望使我們和所有股東受益。

Your next question will come from the line of Steve Lichtman with Oppenheimer.

你的下一個問題將來自史蒂夫·利希特曼和奧本海默的對話。

(inaudible) This is Ron on for Steve. Congrats on the quarter. Just wanted to ask you guys, in your earnings desk, you mentioned potential normalization of procedure volumes in the second half of the year. Following what may have been worked on over the backlog in the first half. So can you guys talk about -- a little bit about what you're hearing from the field on that front? And where do you think we are in terms of the backlog?

（聽不清）這是羅恩為史蒂夫代言的。恭喜本季度。只是想問一下你們，在你們的收益台上，你們提到了下半年程序量可能正常化。以下是上半年可能針對積壓工作所做的工作。那麼你們能談談——一些你們從這方面聽到的消息嗎？您認為我們的積壓情況如何？

Yes, Ron, I think in some ways, it's what we're not hearing from the field. And so if you think about it last year, and we called this out on several of our calls, what we were hearing from doctors in the field was a fair amount of feedback around staffing levels and constraints and the turnover and the inability to hold and retain a fulsome staff that enabled, for example, doctors who have 2 OR base to work in both simultaneously. You were pretty consistently hearing that theme.

是的，羅恩，我認為在某些方面，這是我們在現場沒有聽到的。因此，如果你想想去年的情況，我們在幾次電話會議中都指出了這一點，我們從該領域的醫生那裡聽到的是關於人員配置水平和限制、人員流動以及無法保持和維持的大量反饋。保留足夠的員工隊伍，例如，使擁有兩個手術基地的醫生能夠同時在兩個手術室工作。你經常聽到這個主題。

And I think as we turn the corner into this year and certainly as we've made it along, we've heard less and less of that, if at all, quite frankly, I'm sure it obviously still exists in pockets, but it's less pronounced. And I think the broader point around procedure trends and the backlog is almost more of a macro one. When we look across the landscape, and obviously, you cover a lot of different industries and companies, and we saw this in the first quarter, you see it again in the second. It feels like, in general, procedure volumes have been pretty robust.

我認為，隨著我們進入今年，當然，隨著我們一路走來，我們聽到的這種情況越來越少，如果有的話，坦率地說，我確信它顯然仍然存在於口袋裡，但是它不太明顯。我認為圍繞程序趨勢和積壓的更廣泛的觀點幾乎更多的是宏觀的。當我們縱觀全局時，顯然，你涵蓋了許多不同的行業和公司，我們在第一季度看到了這一點，你在第二季度再次看到了這一點。總的來說，感覺手術量相當強勁。

And I think that, why I can't point any specific number or item in ophthalmology or within MIGS procedures, in general, it feels like folks have been back to work. And they've been working their way through. And net-net, they're making their way through whatever backlog tends to exist. It's impossible to know exactly when that will normalize, but we felt like it made more sense to make the assumption that whatever elevation existed in the first half that it may not continue in the second half. And if it does, obviously, that will accrue to all of our benefits.

我認為，為什麼我不能指出眼科或 MIGS 程序中的任何具體數字或項目，總的來說，感覺人們已經回到了工作崗位。他們一直在努力度過難關。他們正在努力解決任何可能存在的積壓問題。不可能確切知道這種情況何時會正常化，但我們認為更有意義的假設是，無論上半場存在什麼提升，下半場都可能不會持續。如果確實如此，顯然，這將為我們帶來所有好處。

That's great. And just one small follow-up on iDose. Do you guys think there's any chance that a panel will be called for this? Or is it already too late for that to happen?

那太棒了。這只是 iDose 的一個小後續行動。你們認為有可能為此召集一個小組嗎？或者現在已經太晚了？

Ron, I'm happy to take that question. So this is -- it's been asked a few times before, but happy to address it again. We currently do not believe that there'll be an advisory panel that will be requested. And so -- right now that we're moving towards our PDUFA date, everything is on track, going very well.

羅恩，我很高興回答這個問題。所以這是——之前已經被問過幾次了，但很高興再次解決這個問題。我們目前認為不會要求設立​​顧問小組。因此，現在我們正朝著 PDUFA 日期邁進，一切都步入正軌，進展順利。

We just finished a pre-approval inspection which we believe went very, very well, and we'll expect to file a written confirmation of that in the next few weeks. And as well, the FDA is needing CDER, CDRH for a mid-cycle review, and we'll expect to receive some interim questions, which will hopefully put us in a really advantageous position going into the PDUFA date. And so the short answer to your question is, no. We don't expect that there'll be an advisory panel.

我們剛剛完成了預批准檢查，我們相信進展非常非常順利，我們預計將在接下來的幾週內提交一份書面確認書。此外，FDA 需要 CDER、CDRH 進行中期審查，我們預計會收到一些臨時問題，這有望使我們在 PDUFA 日期之前處於真正有利的位置。所以你的問題的簡短答案是，不。我們預計不會有顧問小組。

Your next question comes from the line of Allen Gong with JPMorgan.

你的下一個問題來自摩根大通的龔艾倫。

I think a lot of the questions have been asked already. So I'll just keep it to one. But when I think about iDose, I fully understand that it's kind of hard to predict the success. But when I think about the competitive landscape, the fact that there is a somewhat comparable product. The profiles are clearly very different but somewhat comparable product on the market already.

我認為很多問題已經被問過。所以我就把它保留為一。但當我想到 iDose 時，我完全理解它的成功是很難預測的。但當我考慮競爭格局時，我發現存在某種程度可比的產品。這些配置文件顯然非常不同，但市場上已經有一些類似的產品。

How should we really think about maybe iDose benefiting from that as a secondary player, whether or not we might see competitive dynamics from that early or if it is more just about expanding the market opportunity and kind of establishing iDose as a differentiated solution.

我們應該如何真正考慮 iDose 作為次要參與者從中受益，無論我們是否可能從早期就看到競爭動態，或者它是否更只是為了擴大市場機會以及將 iDose 建立為差異化解決方案。

Well, I'm happy to take the first part of this, Joe answer as you will. But Alan, I would just tell you that I really don't see DURYSTA as something that I would take a lot of comparability towards. I mean you've got a product that is bioerodible, that is lasting a period of 4 months, relatively short period of time, has shown a relatively high rate of endothelial cell loss, which restricts its use to a onetime use and throws off relatively high rates of hyperemia as well, due to its (inaudible) and dosing profile of release versus a product such as what we have, which is showing basically a safety profile where we have no endothelium or limited to minimal endothelial cell loss that we see and a 3% rate of hyperemia and a product that you've seen in the Phase IIb clinical trial that in 70% of patients is controlling glaucoma in 3 years.

好吧，我很高興接受第一部分，喬如你所願地回答。但是艾倫，我只想告訴你，我真的不認為 DURYSTA 是我會進行大量比較的東西。我的意思是，您擁有一種可生物侵蝕的產品，其持續時間為4 個月，相對較短的一段時間，顯示出相對較高的內皮細胞損失率，這限制了其一次性使用，並且相對脫落。充血率也很高，因為它的（聽不清）和劑量分佈與我們擁有的產品相比，基本上顯示出安全性，我們沒有內皮或僅限於我們所看到的最小內皮細胞損失，充血率為 3%，您在 IIb 期臨床試驗中看到的產品可以在 3 年內控制 70% 的患者青光眼。

And so I don't see a lot of comparability between the 2 products. I don't take a lot of, use DURYSTA as a predicate. I think where DURYSTA serves our interest is the fact that they did establish a J-Code at $2,100 for 4 months of therapy, I think that will serve us well going into the pricing for this product. I will tell you this, given some of the limitations of DURYSTA , I might draw some high optimism that even with these limitations in place, there has been a relatively strong appetite, at least for the concept of intracameral drug delivery. Joe?

因此，我認為這兩種產品之間沒有太多可比性。我不採取很多，使用DURYSTA作為謂詞。我認為 DURYSTA 符合我們利益的地方在於，他們確實建立了 4 個月治療費用為 2,100 美元的 J 代碼，我認為這將有助於我們確定該產品的定價。我會告訴你，考慮到 DURYSTA 的一些局限性，我可能會非常樂觀，即使存在這些局限性，人們仍然有相對強烈的興趣，至少對前房內藥物輸送的概念是這樣。喬？

Yes. I'd just add, I think the 2 things that benefit us in the iDose launch, one, specific DURYSTA one not. I think anything today that's helping drive that interventional glaucoma mindset is a positive. As we continue to think about driving that change in standard of care, the fact that DURYSTA and Allergan and their reps have been out talking about that alongside all of the efforts that we're in muscle that we're putting behind that, as you know.

是的。我想補充一點，我認為 iDose 的推出有兩件事對我們有利，一是特定的 DURYSTA，另一件事不是。我認為今天任何有助於推動介入性青光眼心態的事情都是積極的。當我們繼續考慮推動護理標準的變革時，DURYSTA 和艾爾建及其代表已經開始談論這一點，以及我們為此付出的所有努力，正如您所見知道。

I think that continues to hopefully turn the broader industry towards what we think is the optimal course of care for these patients.

我認為這將繼續有望使更廣泛的行業轉向我們認為針對這些患者的最佳護理方案。

And the second thing is, obviously, it's less about any competitor. I think it's more about just the state of the industry -- you think back to when Glaukos first launched MIGS and with iStent, there were a lot of basic blocking and tackling even in the combo cataract setting that the company had to go through around reeducating and teaching surgeons -- surgical techniques that a lot of them hadn't done since the residency.

第二件事顯然是，這與任何競爭對手無關。我認為這更多的是關於行業的狀況——回想一下 Glaukos 首次推出 MIGS 和 iStent 時，即使在組合白內障的情況下，公司也必須圍繞再教育經歷很多基本的阻礙和解決方案。並教授外科醫生——他們中的許多人自從住院醫師實習以來從未做過的手術技術。

And so as we go into any of these things, whether it's iStent infinite or iDose, the good new news is that now surgeons understand much more fulsomely the angle based surgery and the various technical aspects.

因此，當我們討論任何這些事情時，無論是 iStent 無限還是 iDose，好消息是，現在外科醫生對基於角度的手術和各種技術方面有了更充分的了解。

And so it's much more about the features and benefits, the safety profile, as Tom has talked about the individual product and what that use case is for the appropriate patients that are on label. So I think that we enter into it with a far more educated marketplace in terms of interventional - and we're going to obviously do our part to drive that forward even faster.

因此，更多的是關於功能和優點、安全性，正如湯姆談到的單個產品以及該用例對於標籤上的適當患者的用途。因此，我認為我們在介入方面進入了一個受過更多教育的市場——而且我們顯然將儘自己的一份力量來推動這一進程更快。

And our final question will come from the line of Anthony Petrone with Mizuho.

我們的最後一個問題將來自安東尼·佩特龍（Anthony Petrone）和瑞穗（Mizuho）的團隊。

Congrats on a good quarter here. Maybe 2 quick ones. One is on the core mix space. I'm just wondering if you have any views on how it could shape up into next year if non-implantable MIGS procedures are -- become a non-covered procedure across certain MAC territories next year. So how do you see the core space evolving if that scenario plays out?

恭喜您度過了一個美好的季度。也許有2個快的。一是在核心混合空間上。我只是想知道，如果明年非植入式 MIGS 手術成為某些 MAC 地區的非承保手術，您對明年的情況有何看法。那麼，如果這種情況發生，您如何看待核心空間的演變？

And then the second one real quick would just be on the iDose label. Is there anything of note just on the latest views from Glaukos and how you're thinking about duration of the implant what can be included in the label for duration on iDose?

然後第二個很快就會出現在 iDose 標籤上。關於 Glaukos 的最新觀點以及您如何考慮植入物的持續時間，有什麼值得注意的嗎？ iDose 上的持續時間標籤中可以包含哪些內容？

Okay. I'll start and then Tom can jump in the second part around iDose. I think -- as it relates to the proposed LCDs and outcomes, we're prepared for any scenario there that emerges and I'm not sure I would hazard a guess at this stage nor attempt to quantify it because there are so many different factors that could play out, as these things are finalized hopefully in the coming months, if not quarters.

好的。我先開始，然後 Tom 可以跳到圍繞 iDose 的第二部分。我認為，由於它與擬議的 LCD 和結果相關，我們已經為出現的任何情況做好了準備，我不確定我會在現階段冒險猜測，也不會嘗試量化它，因為有很多不同的因素這可能會發生，因為這些事情有望在未來幾個月（如果不是幾個季度）內完成。

Our focus is on building a healthy and growing market that benefits patients. And we think supporting surgeons making clinical decisions and not payers is optimal in that regard. And so really, at the end of the day, if you take a long-term view, I think we would all agree that getting interventional glaucoma, iStent infinite and iDose, right, is probably far more material to our future than those near-term dynamics. And while I understand and appreciate the question, I think, that's where our focus is at.

我們的重點是建立一個健康、不斷增長、造福患者的市場。我們認為，在這方面，支持外科醫生做出臨床決策而不是付款人是最佳選擇。所以說實話，歸根結底，如果你從長遠的角度來看，我想我們都會同意，接受介入性青光眼、iStent 無限和 iDose，對吧，對我們的未來來說可能比那些近期的治療更重要。術語動態。雖然我理解並理解這個問題，但我認為這就是我們的重點所在。

I'm happy to address the second part of your question. So with regards to the label, again, we are under a 505(b)(2) regulatory path and so the likely label that in our expectation would be that I would say something effect for the reduction of intraocular pressure in ocular hypertension and open-angle glaucoma patients.

我很高興回答你問題的第二部分。因此，關於標籤，我們再次處於 505(b)(2) 監管路徑之下，因此我們期望的可能標籤是，我會說對降低高眼壓症和開放性眼壓的眼內壓有效果。角型青光眼患者。

So a significantly wide open label, which will be based really on the 3-month non-inferiority primary efficacy endpoint that we established in the pivotal trial. We do not expect the label to specify our extended duration. For that, I think we've been proficient in extending the Phase IIb study after 3 years. That will become the important component, that 3-year -- 3 cohort study we did with the Phase IIb will allow us to approach payers to be able to substantiate the need both for coverage and payment.

因此，這是一個顯著開放的標籤，它將真正基於我們在關鍵試驗中建立的 3 個月非劣效性主要療效終點。我們不希望標籤指定我們的延長期限。為此，我認為我們已經熟練地在 3 年後擴展了 IIb 期研究。這將成為重要的組成部分，我們在 IIb 期進行的為期 3 年的 3 期隊列研究將使我們能夠接觸付款人，以便能夠證實承保和付款的需求。

I'll now turn the call back over to the company for any closing remarks.

現在我將把電話轉回公司以供結束語。

Okay. Thanks to everybody for all your time and attention today. We thank you for your continued interest and support in Glaukos. Thanks, and goodbye.

好的。感謝大家今天的時間和關注。我們感謝您對 Glaukos 的持續關注和支持。謝謝，再見。

That will conclude today's conference call. We thank you all for joining, and you may now disconnect.

今天的電話會議到此結束。我們感謝大家的加入，現在您可以斷開連接。