Glaukos Corp (GKOS) 2024 Q3 法說會逐字稿

Welcome to Glaukos Corporation's third-quarter 2024 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.

歡迎參加 Glaukos Corporation 2024 年第三季財務業績電話會議。該公司的新聞稿和季度摘要文件的副本均在今天收盤後發布，可在 www.glaukos.com 上查閱。 （操作員指示）本次通話正在錄音，存檔重播將在 www.glaukos.com 的投資者關係部分線上提供。

I will now turn the call over to Chris Lewis, Vice President of Investor Relations and Corporate Affairs. Please go ahead.

現在我將電話轉給投資者關係和公司事務副總裁 Chris Lewis。請繼續。

Thank you and good afternoon. Joining me today are Glaukos Chairman and CEO Tom Burns, President and CMO Joe Gilliam, and CFO Alex Thurman. Similar to prior quarters, the company has posted a document on its investor relations website under the financials and filings quarterly results section titled quarterly summary. This document is designed to provide the investment community with a summarized and easily accessible reference document that details the key facts associated with the quarter, the state of the company's business objectives and strategies, and any forward statements or guidance we may make.

謝謝您，下午好。今天與我一起出席的還有 Glaukos 董事長兼執行長 Tom Burns、總裁兼首席行銷長 Joe Gilliam 以及財務長 Alex Thurman。與前幾季類似，該公司在其投資者關係網站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的、易於理解的參考文件，詳細說明本季度相關的關鍵事實、公司的業務目標和戰略狀況，以及我們可能做出的任何前瞻性聲明或指導。

This document is designed to be read by investors before some regularly scheduled quarterly conference calls. (Operator Instructions)

本文件旨在供投資者在一些定期的季度電話會議之前閱讀。（操作員指令）

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. These include statements about our plans, objectives, strategies, and prospects regarding, among other things, our sales, products, pipeline technologies and clinical trials, US and international commercialization, market development efforts, the 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.

請注意，本次電話會議上所作的除歷史事實陳述之外的所有陳述，關於我們期望、相信或預期未來會發生或可能發生的活動、事件或發展的陳述均為前瞻性陳述。這些聲明包括關於我們的計劃、目標、策略和前景的聲明，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、市場開發努力、我們當前和未來產品的功效、競爭市場狀況、監管策略和我們產品的報銷、財務狀況和經營業績，以及一般宏觀經濟狀況（包括外匯波動）對我們的業務和營運的預期影響。

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.

這些聲明是基於對影響我們的未來事件的當前預期，並受與我們的營運和商業環境有關的風險、不確定性和因素的影響，所有這些都難以預測，其中許多是我們無法控制的。因此，它們可能導致我們的實際結果與前瞻性陳述表達或暗示的結果有重大差異。

Review today's press release and our recent SEC filings for more information about these risk factors. You'll find these documents in the investor relations section of our website at www.glaukos.com.

請查看今天的新聞稿和我們最近向美國證券交易委員會提交的文件，以獲取有關這些風險因素的更多資​​訊。您可以在我們網站 www.glaukos.com 的投資者關係部分找到這些文件。

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's ongoing results of operations, particularly when comparing underlying results from period to period. Please refer to the tables and 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 GAAP 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 持續經營績效進行更全面的分析和更透明的了解，特別是在比較不同時期的基本績效時。請參閱我們網站「投資者關係」部分提供的表格和收益新聞稿，以了解這些指標與最直接可比較的 GAAP 財務指標的對照組。

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

說完這些，我將把電話轉給 Glaukos 董事長兼執行長湯姆·伯恩斯 (Tom Burns)。

Okay, thanks, Chris. Good afternoon, and thank you all for joining us. Today, Glaukos reported record third-quarter consolidated net sales of $96.7 million, up 24% versus the year-ago quarter. As a result of our strong performance, we are raising our full year 2024 Net Sales Guidance Range to $377 million to $379 million versus $370 million to $376 million previously.

好的，謝謝，克里斯。下午好，感謝大家加入我們。今天，Glaukos 公佈第三季綜合淨銷售額創紀錄地達到 9,670 萬美元，較去年同期成長 24%。由於我們的強勁表現，我們將 2024 年全年淨銷售額預期範圍從先前的 3.7 億美元至 3.76 億美元上調至 3.77 億美元至 3.79 億美元。

Our third-quarter record results were primarily driven by both our US and international glaucoma franchises, where we continue to accelerate efforts to expand access to interventional glaucoma tools for the benefit of physicians and patients. Our goal to advance and improve glaucoma treatment by driving earlier intervention continues to build momentum as we lead and work closely with surgeons, thought leaders globally, to organically drive this broader evolution in the standard of care for the benefit of patients. These efforts were on full display at the AAO annual meeting last month, where the interest and excitement levels for interventional glaucoma and our technologies were high.

我們第三季的創紀錄業績主要得益於我們在美國和國際上的青光眼特許經營權，我們將繼續加快努力擴大介入性青光眼工具的使用範圍，使醫生和患者受益。我們的目標是透過推動早期介入來推進和改善青光眼治療，這一目標將繼續增強，我們領導並與全球外科醫生、思想領袖密切合作，有機地推動治療標準的更廣泛演變，使患者受益。這些努力在上個月的 AAO 年會上得到了充分展示，人們對介入性青光眼和我們的技術的興趣和興奮程度很高。

Within our US glaucoma franchise, we delivered record third-quarter sales of $51.6 million on strong year-over-year accelerating growth of 35%, driven by early but growing contributions from iDose TR, along with continued strong growth within our overall iStent portfolio, led by iStent Infinite. On the latter, the utilization of iStent Infinite for glaucoma patients that have failed medical and surgical therapy continues to expand as our ongoing clinical education efforts in improving market access landscapes takes hold.

在我們的美國青光眼特許經營權中，我們第三季度的銷售額創下了5,160 萬美元的紀錄，年增35%，這得益於iDose TR 早期但不斷增長的貢獻，以及我們整體iStent 產品組合的持續強勁成長，由 iStent Infinite 領導。就後者而言，隨著我們在改善市場准入環境方面持續進行的臨床教育工作取得成效，iStent Infinite 對藥物和手術治療失敗的青光眼患者的應用不斷擴大。

It is also worth noting that during the third quarter, five of the seven MACs issued final MIGS LCDs that largely aligned with their proposals as they established coverage for iStent Infinite that is consistent with our original reconsideration request. We look forward to their effective dates later this month, as we expect it will be an important step in unlocking the remaining Medicare Advantage and Commercial Plan coverage for iStent Infinite. That said, I should also note that with any coverage policy change, we may experience some transient turbulence as providers navigate any potential impacts associated with these LCDs.

另外值得注意的是，在第三季度，七個MAC 中的五個發布了最終MIGS LCD，這與他們的提案基本一致，因為他們為iStent Infinite 建立了與我們最初的重新考慮請求一致的覆蓋範圍。我們期待本月稍後的生效日期，因為我們預計這將是解鎖 iStent Infinite 剩餘的 Medicare Advantage 和商業計劃保險的重要一步。儘管如此，我還應該指出，隨著任何覆蓋政策的變化，我們可能會經歷一些短暫的動盪，因為提供者需要應對與這些 LCD 相關的任何潛在影響。

Turning to our procedural pharmaceutical franchise in iDose TR, I am pleased to report that we successfully advanced execution of our detailed launch plans for this first-of-its-kind intracameral procedural pharmaceutical that was designed to deliver glaucoma therapy for up to three years. During the third quarter, the expanded access of iDose TR to all of our sales field personnel helped support a growing number of trained surgeons in expanding utilization.

談到我們在 iDose TR 的程序藥物特許經營權，我很高興地報告，我們成功推進了這種首創的前房內程序藥物的詳細發布計劃，該藥物旨在提供長達三年的青光眼治療。在第三季度，iDose TR 向我們所有的銷售現場人員擴大了訪問權限，幫助支持越來越多訓練有素的外科醫生擴大利用率。

More importantly, outcomes and feedback from a growing number of cases and trained surgeons continue to be very positive and reaffirms our view that with the launch of iDose TR, we are pioneering a brand-new therapeutic category that has the potential to reshape glaucoma management as we know it today.

更重要的是，越來越多的病例和訓練有素的外科醫生的結果和反饋仍然非常積極，並再次證實了我們的觀點，即隨著iDose TR 的推出，我們正在開創一個全新的治療類別，有可能重塑青光眼管理我們今天知道了。

As you know, a key element to this initial stage gating of our iDose TR commercial launch is market access milestones and reimbursement confidence, where we remain focused across a number of areas. First, our team has been hard at work partnering with our customers to ensure a smooth, efficient transition from the miscellaneous drug code to the permanent J-code for iDose TR, J7355, which became effective July 1, 2024. As a reminder, this now effective J-code is expected to increase patient access and will allow us to expand training plans to future ways of surgeons and facilities over time.

如您所知，iDose TR 商業發布初始階段的關鍵要素是市場准入里程碑和報銷信心，我們仍將重點關注多個領域。首先，我們的團隊一直在努力與客戶合作，以確保從雜項藥品代碼順利、高效地過渡到 iDose TR 的永久 J 代碼 J7355（該代碼於 2024 年 7 月 1 日生效）。提醒一下，現在有效的 J 代碼有望增加患者的就診機會，並允許我們將培訓計劃擴展到未來的外科醫生和設施。

While there is certainly more work to do here, particularly as we expand efforts into the commercial arena over the course of 2025 and beyond, we're encouraged by the overall progress our teams are making to support increased reimbursement competence through more streamlined and consistent J-code coverage and payment in several of the MACs to date with more to come.

雖然這裡肯定還有更多工作要做，特別是隨著我們在2025 年及以後將努力擴展到商業領域，但我們對我們的團隊在通過更精簡和一致的J 來支持提高報銷能力方面所取得的整體進展感到鼓舞- 迄今為止，已經在多個 MAC 中實現了代碼覆蓋和付款，未來還將實現更多。

Second, as anticipated, J7355 was included in CMS's latest HOPD and ASC quarterly update addendums, appropriately establishing pricing of J7355 at ASP plus 6% effective as of October 1. And third, we are advancing efforts to secure professional fee coverage and payment with MACs, as well as establish commercial and Medicare Advantage coverage now that the permanent J-code is effective.

其次，正如預期的那樣，J7355 被納入了 CMS 最新的 HOPD 和 ASC 季度更新附錄，適當地確定了 J7355 的定價為 ASP 加 6%，自 10 月 1 日起生效。第三，隨著永久 J 碼的生效，我們正在加強確保專業費用的覆蓋和透過 MAC 支付，並建立商業和醫療保險優勢計劃。

As noted in the past, we expect increasing adoption as reimbursement confidence is gained by our customers as we enter 2025. In addition to our commercial efforts, the launch has been supported by a growing set of clinical literature now consisting of eight different peer-reviewed publications highlighting iDose TR as a transformative new treatment alternative for patients suffering with glaucoma and in ocular hypertension. We also continue to advance our dialogue with the FDA regarding the re-administration of iDose TR, and beyond that, remain on track to commence a Phase 3 clinical trial for iDose TREX, our next-generation iDose therapy, by the end of 2024.

正如過去所指出的，隨著進入 2025 年，客戶對報銷的信心增強，我們預計採用率將會不斷提高。除了我們的商業努力之外，該產品的推出還得到了越來越多的臨床文獻的支持，目前包括八種不同的同行評審出版物，這些出版物強調iDose TR 作為青光眼和眼高壓患者的一種變革性的新治療替代方案。我們也將繼續推進與 FDA 就重新使用 iDose TR 的對​​話，除此之外，我們還計劃在 2024 年底前開始對我們的下一代 iDose 療法 iDose TREX 進行 3 期臨床試驗。

Finally, I should also note CMS issued its final 2025 facility fee and professional fee rules last Friday that largely maintain the 2024 reimbursement assignments and rates associated with our procedures and are consistent with the proposals from earlier this year.

最後，我還要指出，CMS 上週五發布了最終的2025 年設施費和專業費用規則，該規則基本上維持了與我們的程序相關的2024 年報銷任務和費率，並且與今年早些時候的提案一致。

Moving on, our international glaucoma franchise delivered sales of $24.5 million on year-over-year growth of 21%. The strong growth was once again broad-based as we continue to scale our international infrastructure and execute our plans to drive MIGS forward as the standard of care in each region and major market in the world.

我們的國際青光眼特許經營業務實現銷售額 2,450 萬美元，年成長 21%。隨著我們繼續擴大國際基礎設施規模並實施計劃，推動 MIGS 成為全球各個地區和主要市場的護理標準，強勁成長再次具有廣泛基礎。

Persistent with prior quarters this year, our new French CEPS agreement was favorable to our third-quarter reported revenues. We remain in the early stages of expanding our IG and product portfolio initiatives globally ahead of anticipated new product approvals and expanding market access in the years to come. In the interim, we expect the trialing of new competitive products in our major international markets may become an increasing headwind as we enter 2025.

與今年前幾季一樣，我們新的法國 CEPS 協議對我們第三季報告的收入有利。在未來的幾年中，為了迎接新產品的批准和市場准入的擴大，我們仍處於在全球範圍內拓展 IG 和產品組合計劃的早期階段。在此期間，我們預計，進入 2025 年，我們在主要國際市場上試用新的競爭產品可能會成為一股越來越大的阻力。

And finally, our corneal health franchise delivered sales of $20.6 million on a 5% year-over-year growth, including Photrexa Net sales of $17.9 million. As discussed last quarter, our third quarter results reflect the impact to Photrexa realized revenues as a result of our entry as a company into MDRP. Going forward, we continue to focus on expanding access for keratoconus patients suffering from this rare disease.

最後，我們的角膜健康特許經營權實現了 2,060 萬美元的銷售額，年增 5%，其中 Photrexa 淨銷售額為 1,790 萬美元。正如上個季度所討論的，我們的第三季業績反映了我們公司加入 MDRP 對 Photrexa 實現收入的影響。展望未來，我們將繼續致力於擴大患有這種罕見疾病的圓錐角膜患者的治療機會。

Staying on corneal health but shifting gears to our pipeline, we were pleased to recently announce positive top-line outcomes in the second Phase 3 pivotal study for Epioxa, our next-generation corneal cross-linking therapy that met the study's primary efficacy endpoint and, once again, demonstrated the potential of Epioxa to halt or reduce the advancement of keratoconus, a progressive, site-threatening corneal disease.

我們繼續關注角膜健康，但將重心轉移到產品線，我們很高興最近宣布，我們的下一代角膜交聯療法Epioxa 在第二階段3 期關鍵研究中取得了積極的頂線結果，該療法達到了研究的主要療效終點，再次證明了 Epioxa 具有阻止或減緩圓錐角膜（一種進行性、部位威脅性角膜疾病）進展的潛力。

These results further underscore our view that Epioxa may provide the ophthalmic community and patients with the first FDA-approved, noninvasive, corneal cross-linking therapy that does not require the removal of the corneal epithelium, the outermost layer of the front of the eye.

這些結果進一步證實了我們的觀點，即 Epioxa 可能為眼科界和患者提供首個 FDA 批准的非侵入性角膜交聯療法，該療法不需要去除角膜上皮（即眼睛前部的最外層）。

We recently completed a successful clinical pre-NDA meeting with the FDA, in which the agency agreed that our clinical data package is sufficient to support an NDA submission and review. As such, results from this second Phase 3 confirmatory pivotal trial, together with the already completed first Phase 3 pivotal trial, are expected to support our anticipated NDA submission for Epioxa by the end of 2024.

我們最近與 FDA 成功完成了臨床 NDA 前會議，該機構同意我們的臨床資料包足以支持 NDA 的提交和審查。因此，第二階段 3 期確認性關鍵試驗的結果，加上已完成的第一階段 3 期關鍵試驗，預計將支持我們在 2024 年底前提交 Epioxa 的 NDA。

Beyond Epioxa, we continue to prudently invest in and successfully advance our 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. We remain encouraged with the progress our teams are making across our robust portfolio of clinical and preclinical programs focused in the areas of glaucoma, retina, and rare disease. At the same time, as we've discussed, we continue to prioritize the cadence of our investments as we strive to strike the right balance of risk-based spending and our capital position now and in the future.

除了 Epioxa 之外，我們還將繼續審慎投資並成功推進我們新穎、有前景的平台技術，我們相信這些技術能夠顯著擴展我們的潛在市場，並隨著時間的推移從根本上改變我們的公司。我們的團隊在專注於青光眼、視網膜和罕見疾病領域的一系列臨床和臨床前項目中取得了進展，這讓我們感到鼓舞。同時，正如我們所討論的，我們將繼續優先考慮投資節奏，並努力在現在和將來的風險支出和資本狀況之間取得適當的平衡。

In support of this, last month we issued notice of redemption for the remaining $57.5 billion, in principal amount outstanding of our convertible senior notes due 2027. Pursuant to the notice, we anticipate these notes to convert to common stock before the redemption date of December 16, 2024, helping to further solidify our already strong capital position through a deleveraging and de-risking of our balance sheet, as well as a significant reduction in future cash interest expense.

為了支持這一點，上個月我們發出了贖回通知，贖回剩餘的 575 億美元，即 2027 年到期的可轉換優先票據的未償還本金。根據通知，我們預計這些票據將在 2024 年 12 月 16 日贖回日之前轉換為普通股，從而通過去槓桿和降低資產負債表風險來進一步鞏固我們已經強大的資本狀況，以及減少未來現金利息支出。

In conclusion, I am pleased with the strong commercial and development execution of our teams that have continued to demonstrate this year.

總而言之，我對我們團隊今年繼續展現出的強大的商業和開發執行力感到滿意。

We look forward to continuing to build upon the growing momentum in our business over the coming quarters and years. Our foundation is strong, and we are ideally positioned to continue transforming vision for the benefit of patients worldwide.

我們期待在未來幾季和幾年內繼續保持業務的成長勢頭。我們的基礎堅實，我們處於理想的位置，可以繼續改變視力，造福全世界的患者。

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

現在我開始回答問題。操作員？

(Operator Instructions) Tom Stephen, Stifel.

（操作員指示）湯姆·史蒂芬，Stifel。

Nice quarter. I wanted to start with iDose. I'll actually ask both my questions up front. First question, maybe for Tom or Joe to start, we're coming up a year post-approval of iDose. So first question, can you guys talk about what's sort of the top two or three learnings or discoveries during the launch? Just when you think back over the past, yeah, I guess almost 12 months since approval.

不錯的季度。我想從 iDose 開始。我實際上會先提出這兩個問題。第一個問題，也許對 Tom 或 Joe 來說，我們已經到了 iDose 獲批一年後了。所以第一個問題，可以談談發布過程中最重要的兩三個學習或發現嗎？當你回想過去的時候，是的，我想從批准到現在已經快 12 個月了。

And then my second question is kind of a follow-up to that. Maybe Joe or Alex, for you, can you talk about key qualitative sort of puts and takes looking ahead on iDose when we think about the fourth quarter of this year in 2025 and try to dial in our models on iDose revenue. Thanks.

我的第二個問題是與此相關的。也許 Joe 或 Alex，您能否談談展望 2025 年第四季度和嘗試根據我們的 iDose 收入模型對 iDose 進行預測時，對 iDose 進行的關鍵定性分析和展望。謝謝。

Sure. Thanks, Tom. It's Joe. Maybe I'll start off and the others can jump in with any incremental thoughts on your two questions. If we think back on the last year of iDose, I have to say, whenever you enter into something of this magnitude, it's a challenge to forecast all the variables that are in front of you, whether those are variables from the training of your commercial organization to then ultimately leading that out to the field, the market access components and all the key milestones that are there. And I have to say, we're quite proud of now looking back at where we're at, having done a really good job of executing against that plan.

當然。謝謝，湯姆。是喬。也許我先開始，其他人可以針對你的兩個問題提出一些新的見解。如果我們回顧 iDose 去年的發展歷程，我必須說，每當你進入如此規模的領域時，預測你面前的所有變數都是一個挑戰，無論這些變數是否來自商業培訓組織最終將其帶入該領域，包括市場准入組件和所有關鍵里程碑。我必須說，現在回顧我們現在的狀況，我們感到非常自豪，我們確實很好地執行了該計劃。

If you think about the most important thing from a long-term driver perspective, it really is clinical outcomes. And most importantly, we've been really pleased with results on this front so far, as well as kind of the overall clinical receptivity of surgeons towards iDose TR and what that means in terms of potentially changing the paradigm as we go forward. I think that's number one.

如果從長期驅動因素的角度考慮最重要的事情，那確實就是臨床結果。最重要的是，我們對目前這方面的成果感到非常滿意，並且對外科醫生對 iDose TR 的整體臨床接受度以及這對我們未來潛在改變範式的意義也感到非常滿意。我認為這是最重要的。

I think the second thing you've heard us talk about is we knew going in, but the importance of reimbursement confidence to ultimately getting past the, I'll call it initial launch phases, into really the broad clinical adoption phase. And from that standpoint, we continue to be ahead of progress as well, but we still have a fair amount of wood to chop as we move forward.

我認為您聽到我們談論的第二件事是我們知道要進入這個領域，但報銷信心的重要性最終在於，我稱之為初始啟動階段，進入真正廣泛的臨床應用階段。從這個角度來看，我們也繼續保持領先的地位，但是在前進的過程中，我們仍然有相當多的事情需要去做。

And I think that's probably the best transition into the second part of your question, which is the puts and takes as we enter into next year. I think we sit here today very confident about the team's ability to execute and continue to drive clinical adoption and interventional glaucoma overall, as well as with iDose at the center of it.

我認為這可能是進入你問題的第二部分的最佳過渡，即進入明年時我們要考慮的因素。我認為，今天我們坐在這裡對團隊的執行能力非常有信心，並將繼續推動臨床應用和介入性青光眼，以及以 iDose 為核心。

And alongside of that, the big things there are just opening up, from a market standpoint, the various I'll call it key milestones that are in front of us. The first one is getting all of the MACs operating in a way or manner that's similar to the way several of them are today.

除此之外，從市場角度來看，有些大事也剛開始，我稱之為擺在我們面前的關鍵里程碑。第一個是讓所有 MAC 以類似於今天的方式運作。

The second thing is establishing consistent professional fee payments so there's confidence for the surgeon in terms of the economics for them associated with the procedure. And then third will be the methodical long-term deployment of the commercial and Medicare Advantage coverage that we ultimately expect to start You know, over the course of 2025. So plenty of wood to chop, but we're really pleased with where we're at today and as we enter into the fourth quarter and certainly into 2025.

第二件事是建立一致的專業費用支付，以便外科醫生對與手術相關的經濟效益有信心。第三將是對商業和醫療保險優勢計劃進行有條不紊的長期部署，我們最終預計將在 2025 年開始實施。雖然有很多事情需要解決，但我們對目前的狀況以及進入第四季度以及 2025 年的前景感到非常滿意。

That's great. Thanks, Jeff.

那太棒了。謝謝，傑夫。

Lawrence Biegelsen, Wells Fargo.

富國銀行的勞倫斯·比格爾森。

Thanks for taking the question and congrats on a nice quarter here. Joe, I'll ask the iDose question just to back into the numbers here. We're getting to about $7.5 million this quarter in applied Q4, about $10 million. Are we in the right ballpark? And Joe, it looks like you raised by the amount to the beat for 2024. Why did you raise by only the amount to the beat and have one follow-up?

感謝您回答這個問題，並祝賀本季取得良好業績。喬，我會問 iDose 問題只是為了支持這裡的數字。本季我們在第四季的應用營收約為 750 萬美元，約 1,000 萬美元。我們的判斷正確嗎？喬，看起來你已將金額提高到了 2024 年的目標水準。為什麼你只提高了該節拍的金額並且進行了一次跟進？

Sure. Well, first, thanks, Larry. We agree it was a strong quarter and one where we continue to see the acceleration in the overall business as well as specifically US glaucoma. And as I think you're highlighting, it was driven in large part by iDose TR.

當然。好吧，首先，謝謝你，拉里。我們同意這是一個強勁的季度，我們繼續看到整體業務以及特別是美國青光眼業務的加速發展。我認為您強調了這一點，這在很大程度上是由 iDose TR 推動的。

I guess what I can say here is that with that overall growth exerting out of 35% on a year-over-year basis, that was driven by really a doubling of our iDose TR sales versus the second quarter. and alongside of that continued strong double-digit spend portfolio growth. So the latter probably slowed just a touch on a year-over-year basis as our commercial intensity started to focus increasingly on iDose TRs, as we told you it would. But overall, really strong performance across both of those key drivers within the US glaucoma franchise.

我想我在這裡可以說的是，整體成長率達到 35%，這實際上是由於我們的 iDose TR 銷量較第二季翻了一番。同時，支出組合持續保持強勁的兩位數成長。因此，後者的成長速度可能比去年同期略有放緩，因為我們的商業強度開始越來越多地集中在 iDose TR 上，正如我們所說的那樣。但總體而言，美國青光眼特許經營中的這兩個關鍵驅動因素都表現強勁。

As it relates to the guidance side of things, I think it's probably easier to answer that question in breaking it down. So if you think about modeling out our fourth quarter, I'd probably point to a couple key things. The first one is in corneal health, you know, we had previously mentioned that the MDRP headwind was expected to peak in the fourth quarter from a year-over-year impact perspective. So it's worth noting that we expect this franchise will most likely be down on a year-over-year basis in the fourth quarter as we then lap those more difficult comps, if you will, entering into 2025, where we expect to get back to the growth side of the equation for that franchise.

由於它與事情的指導方面相關，我認為將其分解開來回答這個問題可能更容易。因此，如果您考慮模擬我們的第四季度，我可能會指出幾個關鍵的事情。第一個是角膜健康方面，您知道，我們之前提到過，從同比影響的角度來看，MDRP 逆風預計將在第四季度達到頂峰。因此，值得注意的是，我們預計該系列的第四季度同比銷量很可能會下降，因為我們將進入 2025 年，屆時我們將回到該特許經營權的增長方面。

On the international glaucoma front, we do expect lower growth in the fourth quarter. I think you probably have heard this from others, certainly, that have announced their results more recently. We've seen currency move pretty materially against the US dollar entering October, and you combine that with some growing competition in the key markets, I think we'll see growth a bit more tepid in the fourth quarter than what we've seen over the course of the year.

在國際青光眼方面，我們確實預期第四季的成長會下降。我想你可能已經從其他人那裡聽說過這個，當然，他們最近已經公佈了他們的結果。進入 10 月份，我們看到貨幣對美元匯率大幅波動，再加上主要市場的競爭加劇，我認為第四季的經濟成長將比過去幾季略顯疲軟。

And finally, in US glaucoma, I think we expect to see continued acceleration for this franchise versus where we've been. We expect to see continued strong stint growth. Maybe some modest headwinds continue to grow there from the LCDs and the overall commercial focus on iDose, but certainly continue to see the expansion of both iDose as well as the overall US glaucoma business. And really, you put all those together, and those are factored into the guidance that we gave for the fourth quarter and the remainder of the year.

最後，在美國青光眼領域，我認為我們預計該特許經營權的成長速度將比過去更快。我們預計將持續保持強勁成長。也許 LCD 和整體商業重點關注 iDose 會繼續帶來一些適度的阻力，但可以肯定的是，iDose 以及整個美國青光眼業務將繼續擴張。實際上，把所有這些因素放在一起，就會被考慮到我們對第四季和今年剩餘時間的預測。

That's helpful. Just lastly for me, the types of patients using iDose, has anything changed standalone versus combo cataract? Medicare fee-for-service, [Form of Arrest of] Patients, et cetera. Any changes? Thank you.

這很有幫助。最後，對我來說，使用 iDose 的患者類型，單獨使用和組合治療白內障相比有什麼變化嗎？醫療保險按服務收費、病人[逮捕形式]等等。有什麼變化嗎？謝謝。

I wouldn't call out any specific changes relative to where we've been. I think as you get further into the launch, you continue to see increased utilization across all of those categories. So as you know, we've really prioritized and focused on driving standalone utilization of iDose and the overall IG message. But having said that, certainly surgeons are doing it in combination with cataract surgery as well.

我不會指出相對於我們所處位置的任何具體變化。我認為，隨著發布的進一步深入，您將繼續看到所有這些類別的使用率不斷提高。如您所知，我們確實優先考慮並專注於推動 iDose 的獨立利用和整體 IG 資訊。但話雖如此，外科醫生當然也會將其與白內障手術結合起來進行。

And from a utilization standpoint in terms of prior procedures, we've seen it being done after DURYSTA, after SLT, we've seen it being done in phakic eye, pseudophakic eyes, really across the full gamut, which is what you'd expect. And clearly, there'll be a lot more of that to come as we continue to move forward.

從先前手術的使用率來看，我們已經看到它在 DURYSTA 和 SLT 之後被使用，我們已經看到它在有晶狀體眼、人工晶狀體眼中被使用，實際上覆蓋了整個範圍，這就是你預計。顯然，隨著我們不斷前進，還會有更多這樣的情況發生。

From a market access or reimbursement perspective, virtually all of these are being done in Medicare fee-for-service patients. There's probably maybe a couple of exceptions to that, but we really aren't in the position yet where we're greenlighting or driving the expansion into that broader patient arena. We'll do that over the course of 2025 in a methodical fashion.

從市場准入或報銷的角度來看，幾乎所有這些治療都是在醫療保險按服務收費的患者中進行的。可能存在一些例外，但我們實際上尚未批准或推動向更廣泛的患者領域擴張。我們將在 2025 年有條不紊地實現這一目標。

Thanks, Joe.

謝謝，喬。

Ryan Zimmerman, BTIG.

瑞安·齊默爾曼（Ryan Zimmerman），BTIG。

Good evening, and nice quarter. I want to appreciate, Joe, the call you just gave on Larry's answer. As I do the math on it, I'm getting kind of a low double-digit growth rate just in kind of the surgical glaucoma segment of the business. One, am I thinking about that correctly? But as I think about some of the reimbursement dynamics that we just saw Friday from Medicare, do you see stent usage shifting in 2025 or maybe set in another way? Given what we saw for goniotomy and canaloplasty versus what was proposed, would that dampen usage of those technologies in favor of stents, in your view, in 2025?

晚上好，祝大家新年快樂。喬，我想感謝你剛才對拉里的回答所做的評價。當我進行計算時，我發現僅在外科青光眼業務領域中，成長率就達到了較低的兩位數。一、我的想法正確嗎？但是，當我思考我們週五剛看到的醫療保險的一些報銷動態時，您是否認為支架的使用將在 2025 年發生變化，或者可能會以另一種方式發生？鑑於我們所看到的房角切開術和小管成形術與所提議的相比，您認為在 2025 年，這是否會抑制這些技術的使用而轉而使用支架？

Thanks, Ryan. I think what you were asking in the context of low-double digits was with respect to the stent franchise in the third quarter, and I think that's pretty accurate and consistent with what I said in response to Larry's question.

謝謝，瑞安。我認為您在低兩位數的背景下詢問的是關於第三季度的支架特許經營權，我認為這非常準確並且與我在回答拉里的問題時所說的一致。

As you think about moving forward, there are always, in recent quarters and years, been a fair number of puts and takes on this stuff. And I think from our standpoint, we were obviously pleased to see the affirmation of the payments and methodologies and amounts associated with our core procedures.

當你考慮前進時，最近幾個季度和幾年裡，總是會出現很多針對這類事情的爭論。我認為從我們的角度來看，我們顯然很高興看到與我們的核心程序相關的付款和方法以及金額得到確認。

There are puts and takes here. And so when you think about it in the professional standpoint, there's still a fair amount of advantage to the tissue-destructive procedures in terms of the economics to the surgeon. And we'll just have to see how that plays out over the course of the year.

這裡有一些得失。因此，當你從專業角度考慮時，對於外科醫生來說，組織破壞性手術在經濟方面仍然具有相當大的優勢。我們只需觀察這一情況在今年內如何發展。

I think, in totality, our focus is on growing the overall market as fast as we can towards a more interventional approach in a much larger patient population versus necessarily worrying as much about the puts and takes associated with combo cataract utilization versus goniotomy or canaloplasty, for that matter.

我認為，總體而言，我們的重點是盡可能快速地擴大整個市場，以在更大的患者群體中採用更具介入性的方法，而不是過分擔心聯合白內障手術與房角切開術或小管成形術的利弊。

Okay. Very helpful. And then, both you and your competitor struck licensing agreements, I believe, with Ripple Therapeutics this past quarter, which was interesting to see. And I'm just wondering, maybe, Tom, I don't know if you want to comment on this, but how does that play into the development and timelines for next-generation iDose products, given what they offer versus maybe what you're working on internally?

好的。非常有幫助。然後，我相信，您和您的競爭對手在上個季度與 Ripple Therapeutics 達成了許可協議，這很有趣。我只是想知道，湯姆，我不知道你是否想對此發表評論，但考慮到它們提供的產品與你可能提供的產品相比，這對下一代 iDose 產品的開發和時間表有何影響？進行內部工作？

I'll take the first part of your question, or the latter part first, and that's we're going to be entering the clinical trial for TREX, for iDose TREX, by the end of this year. So I think that puts us in a very powerful position to potentially have a commercial product that's available before really any alternative glaucoma product is available in the marketplace.

我先回答你問題的第一部分，或者說後半部分，那就是我們將在今年年底前進入 TREX 和 iDose TREX 的臨床試驗。因此我認為這使我們處於非常有利的地位，有可能在任何替代性青光眼產品真正進入市場之前就推出商業產品。

We're both investing in this technology, but really for principally different reasons. AbbVie has taken the position that they would like to have a product that's really an antecedent of the DURYSTA product. It's a [bioloadable] that's placed in the front of the eye, and as you know, that's always going to have a potential for endothelial cell loss. We've always taken the position that we want to be anchored in the front of the eye and have done so with iDose and with its subsequent generations.

我們都在投資這項技術，但實際上主要的原因不同。AbbVie 的立場是，他們希望擁有一款真正是 DURYSTA 產品的前身的產品。它是一種放置在眼睛前部的[生物可負載]裝置，如你所知，它總是有導致內皮細胞流失的可能性。我們始終堅持將產品固定在眼睛前方，並透過 iDose 及其後續產品實現了這一目標。

Our position with Ripple is to look at Ripple as an opportunity to really reach the back of the eye, for proliferative retinal diseases, potentially for neuroprotection and glaucoma. And we also have rights in cornea. And so we see this as a broad-based opportunity for the intravitreal implants, which have been established by Eylea and Lucentis and others. We propose to move in that vein. And so there really is a bifurcation of how we're looking at this technology.

我們對 Ripple 的立場是將 Ripple 視為真正觸及眼球後部、治療增生性視網膜疾病、神經保護和青光眼的機會。我們對角膜也擁有權利。因此，我們認為這對於玻璃體內植入物來說是一個廣泛的機遇，而這種植入物已由Eylea、Lucentis等公司開發。我們提議朝這個方向行動。因此，我們對這項技術的看法確實存在分歧。

That's helpful, Tom. Thank you.

這很有幫助，湯姆。謝謝。

You're welcome.

不客氣。

Matt Obrien, Piper Sandler.

馬特奧布萊恩、派珀桑德勒。

Good afternoon. Excuse me. Thanks for taking the questions. Just, you know, I don't know, Joe or Tom, what you're willing to share here, but just, you're talking about now opening up iDose to your entire Salesforce. Can you give us a sense for how that group has queued up doc training for Q4 and then how that may extend itself into '25 in terms of utilization? And then what I'm really trying to get at is the street's modeling a pretty meaningful topline acceleration next year, primarily driven by iDose. I mean, is that the way we should be thinking about the business for next year? Is it meaningful acceleration on the top line?

午安.打擾一下。感謝您回答這些問題。只是，你知道，我不知道，喬或湯姆，你願意在這裡分享什麼，但是，你現在談論的是向整個 Salesforce 開放 iDose。您能否向我們介紹一下該小組如何為第四季度安排文件培訓，以及從利用率方面來看，該培訓如何延續到 25 年？我真正想要得到的是，華爾街預測明年營收將出現相當有意義的加速，這主要得益於 iDose 的推動。我的意思是，我們應該這樣考慮明年的業務嗎？這對營收來說是否有顯著的加速作用？

Thanks, Matt. It's Joe. I'll start off there. I think we're starting to settle into an early but consistent trend of dock expansion. I won't get into the specific numbers, but what I can tell you is, obviously, with the establishment of the JCO, that picked up pretty meaningfully in the third quarter, combined with the fact that we really opened up to our entire sales force. And so pretty much now, over the last several months, we've seen a pretty consistent trend of opening up new docks and new accounts.

謝謝，馬特。是喬。我就從那裡開始。我認為我們正開始適應碼頭擴建的早期但持續的趨勢。我不會透露具體數字，但我可以告訴你的是，顯然，隨著 JCO 的成立，第三季的銷售額出現了相當顯著的增長，再加上我們真正向整個銷售部門開放了力量。所以現在，在過去的幾個月裡，我們看到了開設新碼頭和新帳戶的相當一致的趨勢。

Clearly, the next leg of that will be as we continue to establish broader reimbursement confidence across all of the MACs versus the handful that today are in an optimal place, followed by really the establishment of those professional fees. Remember, a significant number of these docs are tied to facilities where they may not have an economic stake. And so from that standpoint, they like what they see from a clinical perspective, but ultimately are going to want to make sure that they're being appropriately compensated for their time and effort as well.

顯然，下一步將是繼續在所有 MAC 中建立更廣泛的報銷信心，而不是目前處於最佳位置的少數 MAC，然後真正建立那些專業費用。請記住，這些文件中的相當一部分與他們可能沒有經濟利益的設施有關。因此從這個角度來看，他們喜歡從臨床角度看到的結果，但最終他們也希望確保他們所付出的時間和精力可以得到適當的補償。

As it relates to how that translates into next year, I'm not sure much has changed in the way that we've thought about this. All of the things are kind of lining up from a market access and doctor training perspective, I think, to continue to drive strong outcomes next year for the remainder of this year. I mean, if you look at where we've been getting to here, this is our third or fourth consecutive quarter, I believe, of accelerating growth in the US glaucoma franchise. I think that portends pretty well for, obviously, hopefully, a very positive outcome for 2025.

至於這對明年的影響，我不確定我們對此的看法是否發生了很大變化。我認為，從市場准入和醫生培訓的角度來看，所有事情都已準備就緒，將在今年剩餘時間內繼續推動明年取得強勁成果。我的意思是，如果你看看我們目前的狀況，我相信這是我們連續第三或第四個季度在美國青光眼特許經營領域加速成長。我認為這顯然預示著 2025 年將取得非常積極的結果。

Got it. Appreciate that. And then I did want to ask Alex about the leverage in the quarter, but I'll save that for later. I was curious about the commentary on reimplantation. I think everybody's just kind of expecting TREX to be the next iteration in terms of second implantation. But any updates from your discussions with the agency in terms of what they're looking for on the reimplantation side? And is that something that potentially could be -- we get some kind of update here over the next several months? Thank you.

知道了。非常感謝。然後我確實想問亞歷克斯有關本季度的槓桿率的問題，但我會把它留到以後再問。我對再植入的評論很好奇。我認為每個人都期待 TREX 成為第二次植入的下一個迭代。但是，您與該機構討論的關於他們在再植入方面尋求什麼的最新進展如何？這是否有可能成為——我們在接下來的幾個月裡會得到某種更新嗎？謝謝。

Yeah, Matt, I'll be happy to take that question. So as we've talked about, we think we have a sophisticated approach and a reason why we should be enabled and allowed to have re-implantation. Not only our approach, but also the fact that, as you know, we've already done a clinical trial where we were able to do 30-odd patients, where we showed a safe re-implantation of the device with really no significant material and to feel cell loss versus control.

是的，馬特，我很樂意回答這個問題。正如我們所討論的，我們認為我們有一個複雜的方法，並且有一個理由來解釋為什麼我們應該被允許重新植入。不僅僅是我們的方法，而且正如你所知，我們已經進行了一項臨床試驗，我們能夠對30 多名患者進行試驗，我們證明了該裝置可以安全地重新植入，並且幾乎不需要任何重要的材料並感覺細胞損失與對照組相比。

So, all the basics are there, and as just a reminder to the investment community, this is a conversation that we wish to have with the FDA in the final minutes, prior to the PDUFA date, and they said they were happy to have it, but we have to move the PDUFA date back probably several months, which obviously was a non-starter. So we're re-approaching.

所以，所有的基本情況都已經準備好了，我只想提醒投資界，這是我們希望在 PDUFA 日期之前的最後一分鐘與 FDA 進行的對話，他們表示很高興能有這樣的對話但我們必須將PDUFA 日期推遲幾個月，這顯然是行不通的。因此我們正在重新接近。

So we have re-engaged with them. We put this approach in front of them. I expect that there'll be several consecutive series of dialogue over the coming months. I would say we remain hopeful, but as we've said all along, we are not counting on this. And so that's why I like the belt-and-suspenders approach of having iDose TREX available in the chamber starting with our clinical trial by the end of this year.

因此我們重新與他們接觸。我們向他們提出了這種方法。我預計未來幾個月將會有幾輪連續的對話。我想說我們仍然充滿希望，但正如我們一直所說的那樣，我們並不依賴這一點。這就是為什麼我喜歡採用雙管齊下的策略，從今年年底的臨床試驗開始，在實驗室中推出 iDose TREX。

Thanks, Tom.

謝謝，湯姆。

Allen Gong, JPMorgan.

摩根大通的艾倫龔（Allen Gong）。

Hi. Thanks for the question. I have one on iDose and then one moving on from that, but I guess piggybacking off some of the other questions that have been asked, just looking at the guide and kind of the implied of, say $100 million in fourth quarter, you talk to some of the challenges you're going to be facing OUS and corneal health, but you also pointed to continued kind of sequential growth from the core -- or maybe not sequential, but core strength inside of iStent and iDose. So I guess, you've given us some direction on what iDose did in second quarter and how that grew in the third quarter. How should we think about what's contemplated in your fourth-quarter guide? How much of that sequential growth is coming from iDose versus iStent?

你好。謝謝你的提問。我有一個關於 iDose 的問題，然後還有一個關於這個問題的問題，但我想，順便問一下其他一些問題，只要看一下指南，以及第四季度的 1 億美元暗示，你就可以和您將面臨的一些挑戰是OUS 和角膜健康，但您也指出了核心的持續連續增長- 或者可能不是連續的，而是iStent 和iDose 內部的核心實力。所以我想，您已經為我們提供了有關 iDose 在第二季度的表現以及第三季度的增長情況的一些指導。我們應該如何看待您在第四季指南中所考慮的內容？與 iStent 相比，iDose 的連續成長有多少來自這裡？

Thanks, Allen. I tried to address it a little bit earlier, but maybe I'll reiterate a couple points around the fourth quarter and specifically on the US glaucoma franchise. I think when you put the puzzle piece together as you were starting to do on the other segments, you're going to get back to US glaucoma that shows continued acceleration and certainly quarter-over-quarter growth as well as year-over-year acceleration for that franchise.

謝謝，艾倫。我嘗試早點解決這個問題，但也許我會重申第四季度的幾個觀點，特別是關於美國青光眼特許經營權。我認為，當你把拼圖碎片拼湊起來，就像你開始在其他部分做的那樣，你就會回到美國青光眼，它顯示出持續的加速，當然還有季度環比增長和同比增長加速該特許經營權。

And underneath that, we continue to expect strong stint growth. to continue. It may have some modest headwinds versus what we've experienced in recent quarters, including the third, driven by some volatility associated with the LCDs coming into effect later this month, as well as the just general overall commercial focus that we have growing on iDose. And I think when you do all of that calculus, you'll see that it implies continued expansion for iDose TR as a part of the overall launch dynamics in the fourth quarter.

在此之下，我們將繼續期待強勁的成長。繼續。與最近幾季（包括第三季）相比，它可能面臨一些適度的阻力，這主要是由於本月稍後生效的LCD 帶來的一些波動，以及我們對iDose 的整體商業關注度不斷提高。我認為，當您進行所有這些計算時，您會發現它意味著 iDose TR 將繼續擴張，作為第四季度整體發布動態的一部分。

Got it. And then kind of moving on to the Epioxa data that you got, if we were to compare it to the results of the first phase three, the outcomes, at least numerically, look pretty similar. So how should we think about your confidence in getting that approved? And then ultimately, once you lap the MDRP headwinds and once you have the full portfolio, how should we think about the growth outlook for that business once you have both products approved? Thank you.

知道了。然後轉到您獲得的 Epioxa 數據，如果我們將其與第一階段第三的結果進行比較，結果至少在數字上看起來非常相似。那麼我們該如何看待您對獲得批准的信心呢？最後，一旦你克服了 MDRP 阻力，並且擁有了完整的產品組合，那麼在兩種產品都獲得批准後，我們應該如何看待該業務的成長前景？謝謝。

Yeah, Allen, I'd be happy to answer that. And so let's take a step back and really talk about Epi-on, which we think is a significant advancement and really the result of years of innovation, work, and investment by us.

是的，艾倫，我很樂意回答這個問題。所以讓我們回顧一下，認真談談 Epi-on，我們認為這是一個重大進步，也是我們多年創新、工作和投資的結果。

The procedure is designed to be truly non-invasive. It's designed to reduce procedural time for the physician. It should improve patient comfort, and it should shorten the visual rehabilitation and recovery time for the patient.

該程式的設計目標是實現真正的非侵入性。其設計目的在於減少醫師的手術時間。它應該提高患者的舒適度，並縮短患者的視覺康復和恢復時間。

And the reason is we don't have to remove and debride the corneal epithelium in order to be able to get a product into the stroma where it can cross-link the collagen fibrils and arrest the progression of keratoconus. So in the case of Epioxa, it truly is a proprietary formulation. It has a surfactant in it, which will allow us to penetrate through the corneal Epithelium. It uses a stronger UVA irradiation protocol, and it has a perfusion of oxygen through these oxygen goggles, which are consumed as part of the procedure. They throw off oxygen-free radicals. Those are the key to reorienting and stiffening the collagen fibrils.

原因是我們不需要去除和清創角膜上皮就可以將產品送入基質，在基質中交聯膠原纖維並阻止圓錐角膜的進展。因此，就 Epioxa 而言，它確實是一種專有配方。它裡面含有界面活性劑，可以讓我們穿透角膜上皮。它使用更強的 UVA 照射方案，並透過這些氧氣護目鏡灌注氧氣，這些氧氣護目鏡在手術過程中被消耗。它們會釋放出氧自由基。這些都是重新定位和強化膠原原纖維的關鍵。

Now, when we look at -- I love the data we were able to achieve with this product. We achieved the primary efficacy endpoint. by demonstrating Kmax treatment effect of one diopter, prospectively defined mean Kmax change versus Epioxa treatment arm versus the sham control. And I think these results are indicative of what we'll want to see in the marketplace. The product works. It shuts off and arrests the progression of keratoconus.

現在，當我們看一下——我喜歡我們能夠透過該產品獲得的數據。我們達到了主要療效終點。透過展示一個屈光度的 Kmax 治療效果，前瞻性地定義了與 Epioxa 治療組和假手術對照組相比的平均 Kmax 變化。我認為這些結果表明了我們希望在市場上看到的情況。該產品有效。它可以阻止和阻止圓錐角膜的進展。

And because it does offer these advantages to the patient of minimizing pain, and increasing visual rehabilitation and recovery, and offers advantages to the clinician by shortening the procedure time, in some cases, as much as a third of what you need to do a Photrexa procedure. I think this has a really strong value proposition to really receive rapid adoption in this rare disease category.

因為它確實為患者提供了這些好處，可以最大限度地減少疼痛，促進視力康復和恢復，並為臨床醫生提供了優勢，縮短了手術時間，在某些情況下，可以縮短Photrexa 所需時間的三分之一程序。我認為這具有非常強大的價值主張，能夠在這種罕見疾病類別中迅速採用。

So, I've said this before, I think this will markedly change The adoption rate and our ability to penetrate the ranks of this rare disease over time. We're excited about it. We're on track. We'll file our NDA by the end of this year. And by the way, as we reported in the script, the FDA has seen our data and we had a meeting with them. The purpose was to obtain agreement from them on the content of the proposed NDA and would it be sufficient or not to support the NDA submission and retain affirmed and validated as an outcome of this meeting that the FDA would accept the proposed clinical package as sufficient to support our NDA submission review.

所以，我之前說過，我認為這將顯著改變採用率和我們隨著時間的推移滲透到這種罕見疾病的能力。我們對此感到很興奮。我們正步入正軌。我們將在今年底前提交保密協議。順便說一句，正如我們在腳本中所報告的，FDA 已經看到了我們的數據，並且我們與他們進行了會談。目的是獲得他們對擬議的新藥申請內容的同意，是否足以支持新藥申請，並作為本次會議的結果，確認和驗證 FDA 將接受擬議的臨床方案，足以支持我們的 NDA 提交審查。

So, a long answer to your question, but this is something that I think will take us in and be a catalyst for growth, certainly in 2026 and beyond.

所以，對於你的問題，我要回答一個很長的問題，但我認為這會帶動我們並成為成長的催化劑，肯定是在 2026 年及以後。

Margaret Kaczor Andrew, William Blair.

瑪格麗特·卡佐爾·安德魯，威廉·布萊爾。

It's Macauley on for Margaret tonight. Thanks for taking our question and congrats on the quarter.

今晚由麥考利代替瑪格麗特演出。感謝您回答我們的問題，並祝賀本季取得的成績。

Heading into the quarter, you mentioned the potential for a reset in the reimbursement dynamics, obviously, as you shifted to that J-code. Just wondering how that has trended over the last few months, whether that be in terms of a reduction of some of those catch-up payments that you've mentioned in the past or other metrics you're looking at. And just as a quick follow-up to that, would you say you're through the majority of that potential coverage denial period, or how should we think about that as you continue to knock down some of these reimbursement dynamics?

進入本季度，您提到了報銷動態重置的可能性，顯然，當您轉向 J 代碼時。只是想知道過去幾個月的趨勢如何，無論是減少您過去提到的一些補繳款項，還是您正在關注的其他指標。作為對此的快速跟進，您是否認為您已經度過了大部分潛在的承保拒絕期，或者當您繼續降低部分報銷動態時，我們應該如何看待這一點？

Thanks, Macauley. I'll try to address both of those. I think first, going into the quarter, we certainly expected a bit of a reset. We saw it, for sure. I mean, as you enter into July and August, even those folks who had done earlier procedures under the C-code environment and been paid, they wanted to make sure that the machinery was working appropriately in the J-code environment.

謝謝，麥考利。我將盡力解決這兩個問題。我認為，首先，進入本季度，我們肯定會出現一些調整。我們確實看見了它。我的意思是，當進入七月和八月時，即使是那些已經在 C 代碼環境下完成早期程序並獲得報酬的人，他們也希望確保機器在 J 代碼環境中正常運行。

As the quarter moved on, you saw these payments coming through. I think the way I would characterize where we're at today is really to kind of break down from a MAC perspective. And this is subjective, but I would say we currently have two MACs that are paying the J-code in a normalized and efficient manner. We have two MACs that are nearly there, but I'd like to see a little bit more evidence before I call it, and three MACs where the process remains more manual and time-consuming.

隨著季度的推移，您會看到這些付款到帳。我認為，我描述我們今天所處狀況的方式實際上是從MAC角度分解。這是主觀的，但我想說我們目前有兩個 MAC 正在以規範化和高效的方式支付 J 代碼。我們有兩個 MAC 已接近完成，但在宣布之前我希望看到更多的證據，還有三個 MAC，其流程仍然更加手動且耗時。

Obviously, that's the way the wheels of progress grind on. It's consistent with our expectations, and we continue to make progress, the pacing of which will remain to be seen over the course of the quarter. But as we had said, I think, from the very beginning, the goal here really was to make sure that as much of this was iron and smoothed out heading into 2025 as possible, and I think we'll remain on track for that.

顯然，這就是進步之輪不斷前進的方式。這與我們的預期一致，而且我們會繼續取得進展，但進展速度仍有待觀察。但正如我們所說的，我認為，從一開始，這裡的目標實際上就是確保在 2025 年之前盡可能地確保一切順利，我認為我們會繼續朝著這個方向前進。

That's great. Thanks again.

那太棒了。再次感謝。

David Saxon, Needham.

大衛薩克森，尼德漢姆。

Great. Good afternoon, everyone, and congrats on the quarter. I'll start with iDose. Maybe can you talk about the utilization trends you're seeing for doctors using iDose? I've heard docs take varied approaches, some starting slow and some seeming to kind of jump all in. How does it look across the cohort, and I guess, has anything surprised you to either the upside or downside? And then I'll have one follow-up for Alex.

偉大的。大家下午好，恭喜本季取得佳績。我將從 iDose 開始。您能談談您觀察到的醫師使用 iDose 的利用趨勢嗎？我聽說醫生們採取了各種各樣的方法，有的開始得很慢，而有的似乎全力以赴。整個群體的情況如何？然後我會對亞歷克斯進行一次跟進。

Well, thanks, David, on the corner. And when it comes to iDose, obviously, we've said this before, I think it probably still is a little bit early to draw too many conclusions from utilization trends. But I think a couple of anecdotes worth noting, as you think about the broader opportunity, almost all of these docs or accounts start off slow. So to your point, I mean, nearly all of them start with a handful of cases to establish reimbursement confidence, but the question is how quickly they move to that next phase where they're starting to think about it clinically.

好吧，謝謝你，大衛，在角落。說到 iDose，顯然我們之前就說過，我認為從利用趨勢中得出太多結論可能還為時過早。但我認為有幾個軼事值得注意，當你考慮更廣泛的機會時，幾乎所有這些文件或帳戶的啟動速度都很慢。所以對於你的觀點，我的意思是，幾乎所有人都從少數案例開始建立報銷信心，但問題是他們多快進入到開始從臨床上考慮的下一個階段。

And one of the most encouraging things we've seen, both evidence in the results of the third quarter as well certainly, but we've experienced thus far in the fourth quarter, is that as that reimbursement confidence is established, in particular in the MAC regions where there's more normalized behavior today, we're seeing a growing number of surgeons adopting it into their routine clinical practice and that expansion of utilization that you would expect. And so for now, it's for those MACs where we're seeing normalized payment schedules, et cetera, it's all about driving that increased utilization day-to-day out while we're still achieving that reimbursement confidence and early expansion in some of the other MAC regions.

我們看到的最令人鼓舞的事情之一，當然也體現在第三季度的業績中，但我們在第四季度迄今為止所經歷的，是隨著報銷信心的建立，特別是在如今，MAC區域的行為更加規範化，我們看到越來越多的外科醫生將其納入日常臨床實踐中，其利用率的擴大也是意料之中的。因此，目前，對於那些我們看到正常付款時間表等的MAC，這一切都是為了推動日常利用率的提高，同時我們仍在實現報銷信心和一些早期擴張其他 MAC 區域。

Great. Thanks for that. And then for Alex, just on the P&L specifically for iDose, I think it's been a drag. So I guess, is it still a drag on gross margins? And then at what point does that flood to become accretive? And then on kind of the middle part of the P&L, is 10% still a good way to think about OpEx growth in 2024? And then given the leverage potential of iDose and how that launches ramping, can you give us any early color on how to think about OpEx growth in 2025? Thanks so much.

偉大的。謝謝。然後對於 Alex 來說，僅就 iDose 的損益表而言，我認為這很麻煩。所以我猜這是否仍會拖累毛利率呢？那麼洪水什麼時候會變得洶湧澎湃呢？那麼，在損益表的中間部分，10% 是否仍然是思考 2024 年營運支出成長的好方法？然後，考慮到 iDose 的槓桿潛力及其如何啟動成長，您能否為我們提供有關如何看待 2025 年營運支出成長的初步資訊？非常感謝。

You bet, David. And thanks for the question. So I'm going to try to hit them all. There was a lot there to unpack, but let's start with the gross margin.

當然，大衛。感謝您的提問。所以我要盡力打完它們。有很多問題需要解開，但我們先從毛利率開始。

And to your point, yes, I mean, we continue to work our way through with iDose and the manufacturing burden that it comes with. It's still a modest headwind on our gross margin, but regardless, it's improving. Every quarter I look at it and see what is happening with the iDose revenues and that associated COGS burden, and it is improving as those units and volumes start to ramp up.

關於您的問題，是的，我的意思是，我們將繼續努力解決 iDose 以及隨之而來的製造負擔。這對我們的毛利率來說仍然是一個小小的阻力，但無論如何，情況正在改善。每個季度我都會查看 iDose 收入和相關銷貨成本負擔的情況，隨著單位數和銷售量的增加，情況也不斷改善。

Our expectations are that we should start to see accretion in the margin by the end of next year, and it's really all dependent upon those iDose unit volumes and manufacturing volumes. It's as simple as that. So we do expect that, but we were pleased to see our margin for the quarter come right in the range that we expected, which was 82% to 83%.

我們預計，到明年年底，利潤率將會開始成長，而這實際上完全取決於 iDose 的單位產量和製造產量。就這麼簡單。所以我們確實預料到了這一點，但我們很高興看到本季的利潤率正好在我們預期的範圍內，即 82% 到 83%。

And the second question around OpEx for the remainder of the year, I think 10% is exactly the right number that we've been guiding to the whole year. If you think about seasonally, we've traditionally had a little bit of a step up sequentially in our fourth quarter operating expense. So if you look at our year-to-date number, we're sitting at a place of, I think it's 290 year-to-date. And if you just take a little bit of a step up from this quarter, you'll get right in that 10% growth rate for the full year zone. And then next year's operating expense, we'll cover that when we kind of cover our 2025 guidance plans in the next call.

第二個問題是關於今年剩餘時間的營運支出，我認為 10% 正是我們對全年預期的正確數字。如果從季節性角度考慮，我們第四季的營運費用通常會比上一季略有增加。因此，如果你看一下我們今年迄今為止的數字，我認為今年迄今為止我們的數字是 290。如果您從本季開始稍微提高一點，您將獲得全年 10% 的成長率。至於明年的營運費用，我們將在下次電話會議中介紹 2025 年指導計畫時涵蓋。

Okay, great. Thanks so much, guys.

好的，太好了。非常感謝大家。

Mike Sarcone, Jefferies.

傑富瑞 (Jefferies) 的邁克薩科內 (Mike Sarcone)。

Hey, good afternoon, and thanks for taking the questions. Just a follow-up on Epioxa. Can you talk about what the reimbursement pathway would look like there once you get clearance, and you start to commercialize? And I believe you could also get a J-code for this. Could you speak to some of those factors?

嘿，下午好，感謝您回答問題。這只是 Epioxa 的後續。您能談談一旦獲得批准並開始商業化後，報銷途徑是什麼樣的嗎？我相信您也可以獲得此 J 代碼。您能談談其中的一些因素嗎？

Yeah, Mike, this is Tom. I'm happy to take that question. So let's first deal with the professional fee. And the good news is we were able to extend the T-code for the professional fee, 0402T, by another five years. I think that takes us to the end of 2029, which means that the Epioxa will be covered. That procedure will be covered under the existing T-code, 0402T, which is, by and large, paying over $2,000 per procedure.

是的，麥克，這是湯姆。我很高興回答這個問題。因此我們先來處理一下專業費用。好消息是，我們能夠將專業費用的 T 代碼 0402T 再延長五年。我認為這會持續到 2029 年底，這意味著 Epioxa 將被覆蓋。該程式將包含在現有的 T 代碼 0402T 中，一般而言，每個程式支付超過 2,000 美元。

On the ability of a J-code, yes, we'll have a new J-code that we'll establish for this premium technology that, if we're successful in getting a PDUFA date in the fourth quarter of 2025, we'll look then to establish and apply for that J-code at the tail end of 2025. And if you follow what happened with iDose, we'd be looking at about six months to get a J-code and get approval for that product.

關於 J 代碼的能力，是的，我們將為這項優質技術建立一個新的 J 代碼，如果我們成功在 2025 年第四季度獲得 PDUFA 日期，我們將在 2025 年底建立併申請該 J 代碼。如果你有在關注 iDose 的情況，你就會知道我們需要大約六個月的時間才能獲得 J 代碼並獲得該產品的批准。

Now, the difference here, the J-code that we had established for iDose, because of the Medicare fee-for-service patients that we were concentrated and focused on, we were able to enter early and to do preliminary cases under the C-code prior to the J-code and to seek and to gain and secure reimbursement.

現在，不同之處在於，我們為 iDose 設立的 J 代碼，由於我們集中精力和專注的醫療保險按服務收費患者，我們能夠儘早進入並在 C 代碼下進行初步病例代碼在J 代碼之前，並尋求、獲得和確保報銷。

Because the Epioxa procedure is almost invariably going to be a commercial payer, we very well may wait until we have that J-code in, let's call it July of 2026, we have that solidified, and that may be the beginning of the predicate for commercial launch. We're still contemplating several scenarios, but my bias would be to do so and to take that track.

因為 Epioxa 治療幾乎肯定會有商業支付，我們很可能要等到 J 代碼出來，比如說 2026 年 7 月，等到它穩定下來，那可能是商業發布。我們仍在考慮幾種方案，但我傾向於這麼做並採取那種方式。

Okay, great. Thanks, Tom. And then my second one, maybe for Alex, could you just talk about progress and targets toward cash flow breakeven and maybe touch on how you think about profitability in the midterm?

好的，太好了。謝謝，湯姆。然後我的第二個問題，也許是給亞歷克斯的，您能否談談實現現金流收支平衡的進展和目標，也許談談您對中期盈利能力的看法？

Yeah, I'd be happy to, Mike. So, again, you saw, I mean, this quarter we were pleased to see we actually generated a small, modest amount of cash, so that was a great result for the quarter, but it was really around just some spending discipline and some other things.

是的，我很樂意，麥克。所以，再說一次，我的意思是，我們很高興看到本季度我們實際上產生了少量現金，所以這對本季度來說是一個很好的結果，但這實際上只是圍繞著一些支出紀律和其他一些事物。

We've talked, you and I and other investors, around the fact that our near-term approach is not going to be with an eye to profitability, but rather cash flow break-even. We want to get back to the point where we live within our means, so to speak, and how we used to before we entered into a very meaningful investment period getting ready for iDose.

我們，你、我和其他投資者，都討論過這樣一個事實：我們的近期方針不是著眼於盈利，而是著眼於現金流盈虧平衡。我們希望回到量入為出的狀態，就像我們在為 iDose 做準備進入一個非常有意義的投資期間之前的狀態一樣。

I will say that as we progress throughout the next several quarters, next year and even the year after that, there's a very strong possibility, given iDose and its launch trajectory, you could see quarters of profitability happen, and that wouldn't be a surprise to us.

我想說的是，隨著我們在接下來的幾個季度、明年甚至後年的進展，考慮到 iDose 及其推出軌跡，很有可能出現幾個季度的盈利，而這不會是讓我們感到驚訝。

But it's not a signal to the community that we are turning our focus towards profitability. Rather, it's just a matter of the ebbs and flows of our revenues and our expenses. But we have such a robust pipeline that we'll continue to invest in those R&D programs and, again, focus on the near term as we focus on cash.

但這並不意味著我們正將重點轉向獲利能力。相反，這只是我們的收入和支出的起伏問題。但是我們擁有如此強大的產品線，我們將繼續投資於這些研發項目，並且再次將重點放在短期內，因為我們關注的是現金。

Understood. Very helpful. Thanks, Alex.

明白了。非常有幫助。謝謝，亞歷克斯。

Joanne Wuensch, Citigroup.

花旗集團的 Joanne Wuensch。

I'll just sort of toss them right up front. I think you previously talked about growth margins in 2024 in the range of 82% to 84%. I wanted to just make sure you're still feeling good about that. And then my second question is really about 2025. I recognize we're a little early for you to be giving guidance, but in looking at the consensus estimates, could you just maybe comment if you feel good, bad, or indifferent about them? Thank you.

我會直接把它們丟到前面。我記得您之前談到 2024 年的成長利潤率在 82% 到 84% 之間。我只是想確保你對此仍然感覺良好。我的第二個問題其實是關於 2025 年的。我知道現在給您指導還為時過早，但在查看一致預期後，您能否評論一下您對它們的感覺是好、壞還是無所謂？謝謝。

Okay, you bet. Hey, Joanne, it's Alex. I'll take the gross margin question. So I think we did start out thinking 82% to 84%, but I did narrow that range as we've gone throughout the year to 82% to 83%, and we continue to feel very good about that range for this year in 2024. That narrowing of the range really had to do with what I was speaking about earlier, just as we continue to launch iDose and have to get over the manufacturing inefficiencies that typically occur when you launch a product. That's kind of broad our margin a little bit, but we do expect accretion to happen certainly in the future and more likely at some time in the latter half of 2025 by the end of the year.

好吧，你打賭。嘿，喬安妮，我是亞歷克斯。我將回答毛利率問題。所以我認為我們一開始確實認為是82% 到84%，但隨著我們全年的進展，我確實將這個範圍縮小到了82% 到83%，而且我們對今年（2024 年）的這個範圍仍然感到非常滿意。範圍的縮小確實與我之前所說的有關，就像我們繼續推出 iDose 並且必須克服推出產品時通常出現的製造效率低下的問題一樣。我們的利潤率有點高，但我們確實預計未來肯定會成長，更有可能是在 2025 年下半年或年底的某個時候。

And then, Joanne, obviously it's early for us to get granular at 2025, as you suggested, and I wouldn't comment on the specific numbers that Streit has out there. I'm probably uncomfortable commenting on some of the macro considerations, which shouldn't come as a huge surprise, but internationally, we think about continuing to build the overall markets outside the United States. Anchored around interventional glaucoma and expanding the market there, hopefully achieving some key product approvals along the way as we take our pipeline abroad. And on the counter side, we expect to continue to see increasing competition, in particular in some of our key markets outside the United States.

然後，喬安妮，顯然現在就確定 2025 年的具體數字還為時過早，正如你所說，而且我不會對 Streit 提供的具體數字發表評論。我可能不太願意對一些宏觀考慮發表評論，這並不奇怪，但從國際上看，我們考慮繼續在美國以外建立整體市場。以介入性青光眼為中心並不斷擴大當地市場，希望在我們將產品線推向海外的過程中獲得一些關鍵產品的批准。另一方面，我們預期競爭將繼續加劇，特別是在美國以外的一些主要市場。

On the corneal health front, we would expect some continued headwinds associated with the Medicaid drug rebate program ahead of an Epioxa approval and launch late in the year, as Tom indicated, although I think some of those headwinds will certainly be able to lap, from a year-over-year perspective, the impact that experienced in 2024.

在角膜健康方面，我們預計在 Epioxa 於今年晚些時候獲批和上市之前，醫療補助藥物回扣計劃將持續帶來一些不利因素，正如湯姆所指出的那樣，儘管我認為其中一些不利因素肯定會從從年比來看，2024 年將經歷這項影響。

And then, as it relates to our US glaucoma franchise, we really expect continued momentum that primarily will be gated by our ability to establish, as I said before, predictable professional fees, and our methodical expansion over the year into commercial Medicare Advantage-covered lives, and our sales force execution against that in terms of training doctors and expanding the utilization of iDose and iStent Infinite in that standalone patient population.

然後，就我們的美國青光眼特許經營權而言，我們確實預計這種勢頭將持續下去，這主要取決於我們建立可預測的專業費用的能力，以及我們今年在商業醫療保險優勢覆蓋範圍內的系統性擴張。

Thank you so much.

太感謝了。

Richard Newitter, Truist Securities. Please go ahead.

Truist Securities 的 Richard Newitter。請繼續。

This is actually Ravi on for Rich. So just a question on going back to iDose. And part of the label is that iDose is available in OHT patients as well. I was hoping you could maybe give a little bit more color around what kind of market addition these patients would represent to the TAM, what kind of reimbursement work maybe you need to secure to get at it, and then should we factor that in potentially to our 2025 iDose forecasts or if you're seeing any uptake right now. Thanks.

這實際上是 Ravi 代替 Rich。我只想問一下關於回到 iDose 的問題。標籤上註明 iDose 也適用於 OHT 患者。我希望您能更詳細地介紹這些患者對 TAM 的市場成長有何影響，您可能需要確保哪些報銷工作才能實現這一目標，然後我們是否應該將這些因素考慮在內我們對2025 年iDose 的預測，或者您現在是否看到任何增長。謝謝。

Thanks, Ravie. I'll start off, and Tom may want to add some color as well. If you think about the overall market, and you specifically referenced ocular hypertension, but I'll comment more broadly. There are approximately 20 million to 21 million eyes in the United States that have either diagnosed glaucoma or ocular hypertension, approximately of which 13 million to 14 million are diagnosed at a given time and 10 million of which are treated. So very, very large overall opportunity.

謝謝，拉維。我先開始，湯姆可能也想添加一些顏色。如果您考慮整體市場，並且您特別提到眼高壓，但我會更廣泛地評論。美國約有 2,000 萬至 2,100 萬人的眼睛被診斷出患有青光眼或眼高壓，其中約有 1,300 萬至 1,400 萬人在特定時間被診斷出來，還有 1,000 萬人得到了治療。因此整體機會非常非常大。

The good news, and I won't belabor the point around our prior studies, but we have a very large study that has significant data attached to treating all of those patient types up and down the disease spectrum, and so we would expect to utilize that as well as any incremental Phase 4 type studies that we are or we will do in the future to help make sure that we secure proper reimbursement coverage.

好消息是，我不會詳細闡述我們先前的研究，但我們有一項非常大的研究，其中包含大量數據，這些數據與治療各種疾病類型的患者有關，因此我們希望利用以及我們正在或將來會進行的任何增量式第4 階段類型的研究，以幫助確保我們獲得適當的報銷範圍。

I think a lot of that comes down to the individual payer types that are out there. Certainly, we have sufficient data to support this within the traditional Medicare arena and have it be on label and supported by hard and significant evidence. Oftentimes, with the commercial payer, even the Medicare Advantage payer types, you have to continue to chip away at that over time with incremental data and advocacy on behalf of those patients that would like to have access with iDose up and down the disease spectrum.

我認為這很大程度上取決於個人付款人的類型。當然，我們在傳統醫療保險領域有足夠的數據來支持這一點，並將其列在標籤上，並有確鑿的重要證據支持。通常，對於商業付款人，甚至是醫療保險優勢計劃(Medicare Advantage) 付款人類型，您必須隨著時間的推移不斷努力，提供增量數據，並代表那些希望在各個疾病範圍內使用iDose 的患者進行宣傳。

Great, thanks. And maybe just one more. You kind of mentioned dialogue with FDA around re-administration. Love to get any more color beyond that, if you're able to supply it. Thank you.

太好了，謝謝。也許還剩一個。您提到了與 FDA 就重新管理進行的對話。如果您能夠提供的話，我很樂意獲得更多顏色。謝謝。

I guess I would defer to my statement before is that we have had initial engagement. They have looked at the sophisticated approach we put in front of them, and we remain hopeful. I don't want to go into any prognostication other than that. We're not counting on the re-implantation. It certainly hasn't been a detriment in the marketplace. We'd like to have it, not counting on it, but again, like the fact that we have Heider's TR waiting the wings to become a de facto reimplantation product if we are unsuccessful in this early attempt.

我想我會堅持我先前的聲明，那就是我們已經進行了初步接觸。他們已經研究了我們向他們提出的複雜方法，我們仍然充滿希望。除此之外我不想做任何預測。我們不指望重新植入。這當然不會對市場造成傷害。我們希望擁有它，但不指望它，但同樣，就像我們有 Heider 的 TR 等待成為事實上的再植入產品，如果我們在這次早期嘗試中失敗的話。

Steve Lichtman, Oppenheimer.

奧本海默的史蒂夫·利希特曼。

You mentioned on the call today and in the past the shift in the focus of the sales force toward iDose, understandably. What is your latest thoughts on whether you'd look to make a bigger expansion of the rep footprint to sufficiently focus on Infinite as well as the core Stent business?

您在今天的電話會議中以及過去提到銷售團隊的重點轉向 iDose，這是可以理解的。您最近有什麼想法，是否希望進一步擴大銷售範圍，以充分專注於 Infinite 以及核心 Stent 業務？

Thanks, Steve. I don't think that our view on that has changed at all. We've said for some time to expect consistent, organic expansion of our sales force, measure it with the growth in our individual territories, both from a volume and revenue perspective. I think we have a pretty good handle on that. We have a lot of experience in our commercial organization running larger businesses in ophthalmology and a pretty good vision for where the sales force ultimately might go to. But for now and in the foreseeable future, I see that to be continued sort of organic expansion where we're at today.

謝謝，史蒂夫。我認為我們對此的看法根本沒有改變。一段時間以來，我們一直表示希望我們的銷售團隊能夠持續、有機地擴張，並從銷售和收入的角度，以我們各個地區的成長來衡量。我認為我們對此有很好的把握。我們的商業組織在經營大型眼科業務方面擁有豐富的經驗，並且對銷售人員的最終發展方向有著良好的願景。但就目前以及可預見的未來而言，我認為這仍將是我們今天所處的持續有機擴張。

Okay, great. What is your latest outlook regarding timing of getting iDose pro fees established across the MACs? How should we be thinking about this in the coming quarters?

好的，太好了。您對在 MAC 中建立 iDose pro 費用的時間安排有何最新展望？在接下來的幾季裡我們應該如何思考這個問題？

Yeah, that's a great question, Steve. I think, obviously we were pleased to see the first MAC establish that professional fee, and we've been pleased to see, albeit inconsistent, but payments across really all the MACs that are consistent in the dollar amounts with what we saw in that professional fee schedule from -- in this case and Meridian.

是的，史蒂夫，這個問題問得非常好。我認為，顯然我們很高興看到第一個 MAC 確定了該專業費用，我們也很高興看到，儘管不一致，但實際上所有 MAC 的付款金額都與我們在該專業費用表來自——在本例中是和Meridian 一起。

Ultimately, professional fees are a volume game, and so as you get MACs providing more consistent, normalized payment on the J-code, you're able to drive volumes, and those volumes ultimately drive the adjudication of the professional fee, which drives professional fee schedules.

最終，專業費用是一場數量遊戲，因此，當你讓MAC在J代碼上提供更一致、更規範的支付時，你就能推動交易量，而這些交易量最終會推動專業費用的裁決，從而推動專業費用表。

Sometimes it will land in that professional fee schedule, and other times it'll just be that they're starting to pay, on a consistent basis, a dollar amount that you can count even if it's not on a schedule. We've said for some time that our expectation would be that as we enter into 2025 that that'll become more front and center, and I think that remains the case.

有時，它會出現在專業費用表中，有時他們只是開始定期支付一筆即使不在計劃表中也可以計算的金額。我們曾經說過，我們期望，隨著我們進入 2025 年，這一點將變得更加重要，我認為情況仍然如此。

Again, it may not all be that they're on actual schedules, but what we're looking for is consistent and dependable or predictable payments on the professional fee side across each MAC.

再次強調，可能並非所有的都是按照實際時間表進行的，但我們尋求的是每個 MAC 在專業費用方面實現一致、可靠或可預測的支付。

Understood. Thank you.

明白了。謝謝。

Eric Wood, Morgan Stanley.

摩根士丹利的艾瑞克‧伍德 (Eric Wood)。

Beautiful, thank you. Just two quick ones for me, and I'll do them both up front if that's all right. I guess, wet AMD, are we still expecting some Phase 1 data in 2025? And then, secondly, any read from DURYSTA's EU marketing authorization, them withdrawing that? I know it's for very different reasons for you guys, but some of the conversion, you might have had patients that were on DURYSTA going to iDose. Is there any implication there at all? Thanks.

很漂亮，謝謝。對我來說只需快速問兩個問題，如果可以的話，我會先問完它們。我猜，濕 AMD，我們是否仍期待 2025 年的一些第一階段數據？其次，從 DURYSTA 的歐盟行銷授權來看，他們撤回了該授權嗎？我知道你們的原因非常不同，但在某些轉換中，可能會讓服用 DURYSTA 的患者轉為服用 iDose。這其中有沒有什麼暗示？謝謝。

I think from a DURYSTA perspective, I wouldn't read that much into it. Obviously, that's very unique to their product, and from their standpoint, I'll defer to AbbVie around the considerations there.

我認為從 DURYSTA 的角度來看，我不會對此進行過多的解讀。顯然，這是他們產品的獨特之處，從他們的角度來看，我會聽從 AbbVie 的考慮。

We've obviously been cognizant from the beginning when it comes to iDose or any of our products that come after administration of DURYSTA to be mindful of any sort of adverse event profile that may exist within that patient. But I don't think there's anything new there. We didn't learn anything from that, nor does it change sort of our go to market strategies in the US or, or abroad. Tom, (inaudible).

顯然，從一開始，當涉及 iDose 或任何在使用 DURYSTA 之後推出的產品時，我們就已經意識到要留意患者體內可能存在的任何不良事件情況。但我不認為那裡有什麼新鮮事。我們從中沒有學到任何東西，也沒有改變我們在美國或國外的市場策略。湯姆，（聽不清楚）。

Yeah, I'd be happy to. So, as you know, we have begun that Phase 1 study of axitinib. And just to remind the investor audience, this is a tyrosine kinase inhibitor, which is a small molecule, which is to treat age-related macular degeneration.

是的，我很樂意。如您所知，我們已經開始了阿昔替尼的第一階段研究。需要提醒投資者的是，這是一種酪胺酸激酶抑制劑，是一種小分子，用於治療老年黃斑部病變。

We've had this product in persistent retinal vessel leakage trials now, really going on over two years. We really like what we see. The results have been rather extraordinary in terms of efficacy. We like that the precedents in the marketplace of people with or companies with similar TKIs are not showing inflammation.

我們現在已經對該產品進行了持續性視網膜血管滲漏試驗，實際上已經進行了兩年多。我們真的很喜歡我們所看到的。從功效來看，結果相當驚人。我們喜歡市場上擁有類​​似 TKI 的人員或公司沒有發炎的先例。

So this all bodes well on a product that may be able to radically change and disrupt a marketplace when and if it's available. So we have begun Phase 1 clinical work outside the United States, and we are in the process of enrolling patients as we speak.

所以這一切都預示著一款產品一旦上市就可能徹底改變並顛覆市場。因此，我們已經在美國以外開始進行第一階段臨床工作，目前正在招募患者。

Our goal would be to have some data, proof-of-concept data available, late in 2025, maybe going into 2026, and then we'll see where we're at. With a positive response, I think this becomes a major catalyst and opportunity for the business.

我們的目標是在 2025 年底，或許是 2026 年，獲得一些數據，即概念驗證數據，然後我們就會知道目前的情況。有了積極的回應，我認為這將成為業務的重要催化劑和機會。

Thanks, guys.

謝謝大家。

Anthony Petrone, Mizuho.

瑞穗的安東尼‧佩特羅內 (Anthony Petrone)。

Thanks. Maybe one on the Medicare Advantage policies you referenced earlier in the call. Maybe just a little bit on timing. Is it possible that we'll see a Medicare Advantage program for iDose TR in 2024 or those 2025 events? And then just to revisit the idea of a rebate program, I think 20% of the patients are still Medicare fee-for-service. And does the company have a strategy to deploy the balance sheet to address the donut hole for those patients? Thanks.

謝謝。也許是您之前在通話中提到的醫療保險優勢政策之一。可能只是時間上有點問題。我們是否有可能在 2024 年或 2025 年的活動中看到針對 iDose TR 的醫療保險優勢計劃？然後重新審視退款計畫的想法，我認為 20% 的患者仍然需要按服務支付醫療保險費用。公司是否有策略來部署資產負債表來解決這些患者的「甜甜圈洞」問題？謝謝。

Sure, Anthony. I think when it relates to Medicare Advantage, I want to separate between sort of policy establishment or coverage and our sort of commercial support for that in the marketplace. If you went and searched today, there is quite a bit of actual coverage for iDose TR, both in the commercial arena as well as the Medicare Advantage arena. Our payer team has been hard at work since the project approval and has done a great job of establishing coverage across that entire landscape.

當然，安東尼。我認為，當它與醫療保險優勢計劃相關時，我想將政策制定或覆蓋範圍與我們在市場上提供的商業支援區分開來。如果您今天去搜索，您會發現 iDose TR 的實際報告相當多，無論是在商業領域還是在醫療保險優勢領域。自從專案批准以來，我們的付款人團隊一直在努力工作，並在建立整個領域的覆蓋範圍方面做得非常出色。

What we're really talking about here is our ability to deliver that to the marketplace, support that, the complexities associated with dealing with commercial payers and Medicare Advantage from a prior authorization standpoint, as well as some of the other things that come along with those payers. It's something we want to make sure that we've established and solid footing with Medicare fee-for-service before we enter into it.

我們在這裡真正談論的是，我們有能力將其推向市場，支持它，從事先授權的角度處理與商業付款人和醫療保險優勢計劃相關的複雜性，以及隨之而來的一些其他事情。那些付款人。在加入醫療保險按服務收費模式之前，我們要確保已經為其打下了堅實的基礎。

So, as I said earlier, we'll really start to turn that on in 2025. Over the course of the year, and we'll do so very methodically, we don't want to get ahead of ourselves in this part of the payer landscape. We want to make sure that we do it the right way for the long term on that.

所以，正如我之前所說，我們將在 2025 年真正開始實現這一目標。在這一年中，我們會非常有條不紊地進行這項工作，我們不想在付款人領域的這一部分超前。我們希望確保我們能長期以正確的方式做這件事。

As it relates to rebate programs, which I'll say are actually more co-pay assistance or out-of-pocket programs, those are really relegated, like all pharmaceutical companies, to the commercial patients out there that you can't do anything about federally insured patients Medicare or Medicare Advantage. When you talk about the donut hole, I think we have to think about that as more of a Part D issue. For Part B patients, the vast, vast majority, 90%-plus, have supplemental or secondary insurance that covers their out-of-pocket expenses on procedures like (inaudible). So we do plan on having an out-of-pocket program, but it'll be oriented towards those commercially covered lines.

至於回扣計劃，我想說的是，這實際上更多的是共同支付援助或自付費用計劃，這些計劃實際上和所有製藥公司一樣，都是針對商業患者的，你對此無能為力有關聯邦保險病患的醫療保險或醫療保險優勢計劃。當你談到甜甜圈洞時，我認為我們必須將其視為 D 部分問題。對於 B 部分患者，絕大多數（90% 以上）都有補充或次要保險，以支付以下程序的自付費用：（聽不清楚）。因此，我們確實計劃推出一項自付費用計劃，但它將面向那些商業覆蓋的線路。

Thank you.

謝謝。

All right, I will now turn the call back over to Glaukos for closing remarks.

好的，現在我將把電話轉回給 Glaukos 做結束語。

Okay, I want to thank you all for your time and attention today, and thank you as well for your continued interest and support of Glaukos. Goodbye.

好的，我要感謝大家今天的時間和關注，也感謝大家對 Glaukos 的持續關注和支持。再見。