Glaukos Corp (GKOS) 2025 Q2 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Welcome to Glaukos Corporation's second-quarter 2025 financial results conference call.

    歡迎參加 Glaukos Corporation 2025 年第二季財務業績電話會議。

  • Copies of the company's press release and quarterly summary document, both issued after the market closed today, are available at www.glaukos.com.

    該公司的新聞稿和季度摘要文件的副本均於今天收盤後發布,可在 www.glaukos.com 上查閱。

  • After the speaker's remarks, there will be a question-and-answer session. (Operator Instructions)

    演講者發言後,將進行問答環節。(操作員指示)

  • This call is being recorded and an archived replay will be available online in the Investor Relations section at www.glaukos.com.

    本次電話會議正在錄音,存檔重播可在 www.glaukos.com 的投資者關係部分線上取得。

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

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

  • Christopher Lewis - Vice President, Investor Relations & Corporate Affairs

    Christopher Lewis - Vice President, Investor Relations & Corporate Affairs

  • Thank you. Good afternoon.

    謝謝。午安.

  • Joining me today are Glaukos' Chairman and CEO, Tom Burns; President and COO, Joe Gilliam; and CFO Alex Thurman.

    今天與我一起出席的還有 Glaukos 董事長兼首席執行官湯姆·伯恩斯 (Tom Burns)、總裁兼首席營運官喬·吉列姆 (Joe Gilliam) 和首席財務官亞歷克斯·瑟曼 (Alex Thurman)。

  • Similar to prior quarters, the company has posted a document on its Investor Relations website under the Financials & Filings' Quarterly Results section, titled Quarterly Summary.

    與前幾季類似,該公司在其投資者關係網站的「財務與文件」季度業績部分發布了一份名為「季度摘要」的文件。

  • 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. This document is designed to be read by investors before the regularly scheduled quarterly conference call.

    本文件旨在為投資界提供一份概要且易於理解的參考文件,其中詳細說明了與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。本文件旨在供投資者在定期舉行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,對於本次電話會議,我們將進行簡短的準備好的發言,然後轉入問答環節。

  • 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.

    為了確保有充足的時間和機會回答每個人的問題,我們要求您只提出一個問題和一個後續問題。如果您還有其他問題,您可以重新加入佇列。

  • 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. 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, product approvals, 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,除歷史事實陳述外,本次電話會議中涉及我們預期、相信或預期未來將發生或可能發生的活動、事件或發展的所有陳述均為前瞻性陳述。這些聲明包括有關我們的計劃、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、市場開發工作、產品批准、我們當前和未來產品的功效、競爭市場地位、監管策略和產品報銷、財務狀況和經營業績,以及一般宏觀經濟條件(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, it 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相關的風險、不確定性和因素的影響。所有這些都很難預測,其中許多是我們無法控制的。因此,這可能會導致我們的實際結果與前瞻性陳述所表達或暗示的結果有重大差異。

  • Please review today's press release or 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或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 the 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.

    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。

  • Please refer to the tables on our earnings press release available in the Investor Relations section of our website for reconciliation of these measures to their most directly comparable GAAP financial measure.

    請參閱我們網站投資者關係部分提供的收益新聞稿中的表格,以了解這些指標與最直接可比較的 GAAP 財務指標之間的對應關係。

  • 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)。

  • Thomas Burns - Chairman of the Board, Chief Executive Officer

    Thomas Burns - Chairman of the Board, Chief Executive Officer

  • Okay. Thanks, Chris. Good afternoon and thank you, all, for joining us.

    好的。謝謝,克里斯。下午好,感謝大家加入我們。

  • Today, Glaukos reported record second-quarter consolidated net sales of $124.1 million, up 30% on a reported basis or 29% on a constant currency basis versus the year-ago quarter. As a result of our strong performance, we are raising our full-year 2025 net sales guidance range to $480 million to $486 million compared to $475 million to $485 million previously.

    今天,Glaukos 公佈其第二季合併淨銷售額創歷史新高,達到 1.241 億美元,按報告基礎計算比去年同期增長 30%,按固定匯率計算增長 29%。由於我們強勁的業績,我們將 2025 年全年淨銷售額預期範圍從先前的 4.75 億至 4.85 億美元上調至 4.80 億至 4.86 億美元。

  • Our second-quarter record results reflect a sustained growth acceleration in our business driven, by growing iDose TR adoption and utilization, along with our broader interventional glaucoma, or IG, initiatives globally.

    我們第二季創紀錄的業績反映了我們業務的持續成長加速,這得益於 iDose TR 的採用和利用率的不斷提高,以及我們在全球範圍內更廣泛的介入性青光眼 (IG) 計劃。

  • While we are in the early stages of these IT efforts, our focus remains on driving new standalone intervention therapies designed to slow disease progression and reduce drug burden for the benefit of physicians and patients. We continue to be encouraged with the increasing levels of clinical interest for this paradigm-changing evolution.

    雖然我們還處於這些 IT 工作的早期階段,但我們的重點仍然是推動新的獨立幹預療法,旨在減緩疾病進展並減輕藥物負擔,使醫生和患者受益。我們對這種改變範式的演變的臨床興趣日益增加感到鼓舞。

  • Within our US Glaucoma franchise, we delivered record second-quarter net sales of $72.3 million and strong year-over-year growth of 45%, driven by growing contributions from iDose TR, which generated sales of approximately $31 million in the second quarter.

    在我們的美國青光眼特許經營業務中,我們實現了創紀錄的第二季度淨銷售額 7230 萬美元,同比增長 45%,這得益於 iDose TR 不斷增長的貢獻,iDose TR 在第二季度創造了約 3100 萬美元的銷售額。

  • iDose TR, a first-of-its kind intracameral procedural pharmaceutical designed to continuously deliver glaucoma drug therapy for up to three years, continues to build commercial momentum supported by positive clinical outcomes and [search-and-feedback] that 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.

    iDose TR 是首創的前房內程序性藥物,旨在持續提供長達三年的青光眼藥物治療,在積極的臨床結果和[搜索和反饋]的支持下,其商業勢頭持續增強,這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,有可能重塑我們今天所知的青光眼管理。

  • Operationally, our teams continue to make great progress in the execution of our detailed launch plans for iDose TR, including first, growing the universe of training surgeons and accounts; second, expanding utilization of the installed active surgeon base; third, broadening and streamlining market access among MACs, commercial, and Medicare Advantage payers; fourth, expanding the robust body of clinical evidence; and fifth, accelerating marketing investments to support increased patient awareness and education.

    在營運方面,我們的團隊在執行 iDose TR 的詳細發布計劃方面繼續取得巨大進展,包括:第一,擴大培訓外科醫生和帳戶的範圍;第二,擴大已安裝的活躍外科醫生基礎的利用率;第三,擴大和簡化 MAC、商業和醫療保險優勢支付者的市場准入;第四,擴大強有力的臨床證據體系;

  • Shifting to our US Stent business, as anticipated, the 5 MAC LCDs implemented in the fourth quarter of 2024 continued to cause some transient turbulence in the market during the second quarter as surgeons navigate restrictions when using two MIGS surgical devices in the same procedures. We expect this MIGS market headwind will continue over the course of 2025 as providers continue to navigate the impacts associated with these LCDs until it anniversaries later this year.

    轉向我們的美國支架業務,正如預期的那樣,2024 年第四季度實施的 5 個 MAC LCD 在第二季度繼續引起市場的一些短暫動盪,因為外科醫生在同一手術中使用兩個 MIGS 手術設備時會遇到限制。我們預計,MIGS 市場逆風將持續到 2025 年,因為供應商將繼續應對與這些 LCD 相關的影響,直到今年稍後週年紀念日。

  • As a reminder, our second-quarter US Glaucoma results also reflect the expiration of royalty payments associated with the Hydrus Microstent, which concluded in late April.

    提醒一下,我們第二季度的美國青光眼業績也反映了與 Hydrus Microstent 相關的特許權使用費的到期,該費用於 4 月底到期。

  • Earlier this month, CMS issued its proposed rules for 2026, which, as drafted, largely maintained the 2025 APC assignments and modestly increased facility fee rates associated with our procedures across both the hospital outpatient and ASC settings.

    本月初,CMS 發布了 2026 年擬議規則,該規則草案基本上維持了 2025 年的 APC 分配,並適度提高了與醫院門診和 ASC 環境中的程序相關的設施費率。

  • In contrast, CMS has proposed reductions in physician fee reimbursement for several Category I CPT codes across ophthalmology, including for cataract and surgical MIGS procedures specifically, along with several other specialties. These stem primarily from a major revision in how CMS allocates indirect practice expenses within its RVU methodology, particularly impacting services performed in the facility outpatient setting.

    相較之下,CMS 提議減少眼科領域多個 I 類 CPT 代碼的醫師費用報銷,特別是白內障和 MIGS 手術以及其他幾個專科。這些主要源自於 CMS 在其 RVU 方法中分配間接實務費用的方式的重大修訂,特別是影響了在設施門診環境中提供的服務。

  • We tend to support our customers and societies as they educate CMS on the proper assumptions associated with this proposed methodology shift. Beyond that, we believe these proposed changes further support a more diversified practice mix that includes intervention of glaucoma treatment and underscores the value of our standalone therapies such as iDose TR and iStent infinite, which, as procedures covered by Category III codes, are currently unaffected by this proposed physician fee rule.

    我們傾向於支持我們的客戶和社會,因為他們會就與此提議的方法轉變相關的正確假設對 CMS 進行教育。除此之外,我們相信這些擬議的變更將進一步支持更多樣化的實踐組合,包括青光眼治療幹預,並強調我們的獨立療法(如 iDose TR 和 iStent infinite)的價值,作為 III 類代碼涵蓋的程序,它們目前不受此擬議的醫師費用規則的影響。

  • Moving on, our International Glaucoma franchise also delivered record net sales of $31.3 million and year-over-year growth of 20% on a reported basis and 15% on a constant currency basis. This 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.

    此外,我們的國際青光眼特許經營業務也實現了創紀錄的 3,130 萬美元淨銷售額,按報告基礎計算同比增長 20%,按固定匯率計算增長 15%。這一強勁成長再次具有廣泛的基礎,因為我們繼續擴大我們的國際基礎設施並執行我們的計劃,推動 MIGS 成為世界各個地區和主要市場的護理標準。

  • Last month, we were pleased to announce EU MDR clearance for iStent infinite, along with several of our other leading trabecular micro-bypass MIGS technologies. A note: this clearance provides a broad label for iStent infinite indicator for patients with all stages of open-angle glaucoma in both combo cataract and standalone procedures.

    上個月,我們很高興地宣布,iStent infinite 以及我們的其他幾種領先的小梁微旁路 MIGS 技術獲得了歐盟 MDR 批准。注意:此項許可為 iStent 無限指示器提供了廣泛的標籤,適用於聯合白內障和獨立手術中所有階段的開角型青光眼患者。

  • These important milestones, which mark our company's long-awaited first approvals under the new EU Regulatory Framework, will not only help us maintain and grow our presence in Europe but also advance and accelerate our broader IG initiatives globally. We plan to commence commercial launch activities for iStent infinite in our key European markets at the upcoming ASCRS' Annual Meeting in September.

    這些重要的里程碑標誌著我們公司在新的歐盟監管框架下獲得了期待已久的首次批准,這不僅有助於我們維持和擴大在歐洲的業務,而且還將推進和加速我們在全球範圍內更廣泛的投資基金計劃。我們計劃在 9 月即將舉行的 ASCRS 年會上在我們的主要歐洲市場開始 iStent infinite 的商業發布活動。

  • As previously discussed, we continue to expect the trialing of new competitive products. Some of our major international markets may become an increasing headwind as we progress through 2025.

    如同先前所討論的,我們繼續期待新的競爭產品的試用。隨著我們進入 2025 年,一些主要的國際市場可能會成為越來越大的阻力。

  • And finally, our Corneal Health franchise delivered net sales of $20.6 million and a year-over-year growth of 4%, including Photrexa net sales of $17.9 million. As discussed previously, our second-quarter results reflect the continued impact of Photrexa realized revenues as a result of our entry as a company into the Medicaid Drug Rebate Program or NDRP.

    最後,我們的角膜健康特許經營權淨銷售額達 2,060 萬美元,年增 4%,其中 Photrexa 淨銷售額達 1,790 萬美元。如前所述,我們的第二季業績反映了 Photrexa 因加入醫療補助藥品回扣計劃(NDRP)而實現的收入的持續影響。

  • Shifting gears to our Corneal Health pipeline and FDA's ongoing NDA review for Epioxa, our next-generation corneal cross-linking iLink therapy for the treatment of keratoconus, a rarely diagnosed sight-threatening disease, during the second quarter, we completed several important review-related milestones, including a successful Pre-Approval Inspection or PAI at our Burlington, Massachusetts facility, along with a productive post-mid-cycle review meeting with the agency as we continue to progress according to the established PDUFA date of October 20, 2025. Alongside this regulatory review, our commercial and market access teams continue to make solid progress in the preparation and planning of the Epioxa commercial launch targeted for next year.

    我們在第二季度轉向角膜健康管道和 FDA 正在進行的 Epioxa NDA 審查,Epioxa 是我們的下一代角膜交聯 iLink 療法,用於治療圓錐角膜,這是一種罕見的視力威脅性疾病,我們完成了幾個重要的審查相關里程碑,包括在馬薩諸塞州伯靈頓的工廠成功進行的上市前檢查或 PAI,以及幾個重要的審查相關里程碑,包括在馬薩諸塞州伯靈頓的工廠成功進行的上市前檢查或 PAI,以及與該機構進行富有成效的 15 月20 日取得進展。除了此次監管審查之外,我們的商業和市場准入團隊還在為明年 Epioxa 商業發布的準備和規劃方面繼續取得堅實進展。

  • As a reminder, this potential approval would provide care to patients in the [ophthalmic] community, with the first FDA-approved surgery-free topical drug therapy that's catalyzed by pulse oxygen and light that does not require the removal of the corneal epithelium, the outermost layer of the front of the eye.

    提醒一下,這項潛在的批准將為眼科社區的患者提供護理,這是 FDA 批准的首個無需手術的局部藥物療法,該療法由脈衝氧和光催化,不需要去除角膜上皮(眼睛前部的最外層)。

  • An Epioxa approval would also provide us with the opportunities to launch this pharmaceutical therapy supported by the right, long-term pillars to optimize patient access -- a persistent and, at times, frustrating challenge for us, historically, with Photrexa.

    Epioxa 的核准也將為我們提供機會,推出這種藥物療法,並以正確的長期支柱為支持,優化患者的治療可及性——從歷史上看,對於我們 Photrexa 來說,這是一個持續的、有時令人沮喪的挑戰。

  • Because we believe Epioxa, which is designed to preserve the corneal epithelium, streamline the procedure, improve patient comfort, and shorten recovery time, represents a potentially breakthrough treatment advantage and advancement for (inaudible) patients, we anticipate some potential transient disruption with our US Corneal Health franchise as the market transitions from Photrexa to Epioxa, following targeted approval, which is reflected in our latest full-year guidance outlook.

    因為我們相信 Epioxa 旨在保護角膜上皮、簡化手術、提高患者舒適度並縮短恢復時間,對(聽不清)患者來說代表著一種潛在的突破性治療優勢和進步,我們預計,隨著市場從 Photrexa 轉向 Epioxa,在獲得有針對性的批准後,我們全年的美國角膜健康特許經營權可能會出現一些短暫的中斷,這反映在我們全年的指導中。

  • Beyond Epioxa, we continue to advance several other important clinical programs across our five novel therapeutic platforms. Within our iStent Surgical Glaucoma platform, we are advancing patient enrollment in a PMA pivotal trial for iStent infinite in mild to moderate glaucoma patients, as well as a 510(k) pivotal trial for the PreserFlo MicroShunt.

    除了 Epioxa 之外,我們還將繼續透過五個新型治療平台推進其他幾個重要的臨床計畫。在我們的 iStent Surgical Glaucoma 平台內,我們正在推進針對輕度至中度青光眼患者的 iStent infinite PMA 關鍵試驗以及 PreserFlo MicroShunt 的 510(k) 關鍵試驗的患者招募。

  • Within our iDose platform, we're advancing the Phase 2b/3 clinical program for iDose TREX, our next-generation iDose therapy, with patient enrollment already underway and now expect an FDA decision regarding re-administration for iDose TR in early 2026.

    在我們的 iDose 平台內,我們正在推進下一代 iDose 療法 iDose TREX 的 2b/3 期臨床計劃,患者招募工作已在進行中,目前預計 FDA 將於 2026 年初就 iDose TR 的重新給藥做出決定。

  • Within our iLink platform, in addition to the ongoing Epioxa FDA review, we are also advancing Phase 2 trials for our third-generation iLink therapy.

    在我們的 iLink 平台內,除了正在進行的 Epioxa FDA 審查之外,我們還在推進第三代 iLink 療法的 2 期試驗。

  • Within our iLution platform, we remain on track to file a US FDA IND and commence a clinical trial for iLution Demodex blepharitis later this year.

    在我們的 iLution 平台內,我們將繼續按計劃提交美國 FDA IND 並在今年稍後開始 iLution 蠕形蟎瞼緣炎的臨床試驗。

  • Finally, within our Retinal platform, we are advancing a first in-human clinical development program for GOK-401, our intravitreal multi-kinase inhibitor retinal program in wet AMD patients, patients, where we now also have an open US FDA IND.

    最後,在我們的視網膜平台內,我們正在推進 GOK-401 的首個人體臨床開發計劃,這是我們針對濕性 AMD 患者的玻璃體內多激酶抑製劑視網膜計劃,目前我們也已獲得美國 FDA 的開放 IND。

  • 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. At the same time, as we consistently discussed, we continue to prioritize the cadence of our investments as we strive to strike the right balance of risk-based spending while maintaining our strong capital position, both now and in the future.

    正如您所看到的,當談到我們相信我們的管道計劃可能創造的巨大潛在價值時,我們感到非常興奮。同時,正如我們一貫討論的那樣,我們將繼續優先考慮投資節奏,努力在基於風險的支出之間取得適當的平衡,同時保持我們現在和將來的強大資本狀況。

  • This disciplined approach has enabled us to stay active on the business development front, with a focus on transactions that complement and enhance our existing organic growth initiatives.

    這種嚴謹的方法使我們能夠在業務發展方面保持活躍,並專注於補充和增強我們現有有機成長計劃的交易。

  • During the second quarter, we put the strategy to work with the small acquisition of Mobius Therapeutics, whose lead compound Mitosol is the only FDA-approved ophthalmic formulation of mitomycin-C or MMC, which is often utilized as an adjunct in late-stage glaucoma filtration procedures.

    在第二季度,我們實施了該策略,小規模收購了 Mobius Therapeutics,該公司的主導化合物 Mitosol 是唯一獲得 FDA 批准的絲裂黴素 C 或 MMC 眼科製劑,通常用作晚期青光眼濾過手術的輔助手段。

  • This addition helps to solidify our supply chain, as it is being utilized alongside the PreserFlo MicroShunt in our active 510(k) study. It will also support our broader lates-stage glaucoma tertiary care efforts over time and further add to our deepening relationship within the glaucoma specialist community.

    這項新增功能有助於鞏固我們的供應鏈,因為它與我們正在進行的 510(k) 研究中所使用的 PreserFlo MicroShunt 一起使用。它還將支持我們更廣泛的晚期青光眼三級護理工作,並進一步加強我們與青光眼專家社群之間的深化關係。

  • We also continue to invest operationally to support our long-term growth plans with the purchase of an additional building at our Aliso Viejo headquarter campus during the second quarter. Excluding these two one-time investments, our underlying cash and equivalence grew by more than $4 million in the second quarter.

    我們還將繼續進行營運投資,以支持我們的長期成長計劃,並於第二季度在 Aliso Viejo 總部園區購買了一棟額外的建築。除這兩筆一次性投資外,我們第二季的基礎現金和等價物增加了 400 多萬美元。

  • In conclusion, I'm very pleased to put on record quarter and sustained strong 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,我很高興看到我們的業務創下季度新高並保持強勁勢頭,我們將繼續成功推進我們的使命,透過開拓新穎的[無滴]平台來真正改變視力,這些平台可以顯著提高護理標準並改善患有視力威脅性慢性眼病的患者的預後。

  • Our foundation is strong. We are ideally positioned to continue transforming vision for the benefit of patients worldwide.

    我們的基礎很牢固。我們擁有理想的條件,可以繼續改善視力,造福全世界的患者。

  • With that, I'll open the call for questions. Operator.?

    現在,我將開始回答問題。操作員。 ?

  • Operator

    Operator

  • (Operator Instructions)

    (操作員指示)

  • Tom Stephan, Stifel.

    湯姆‧史蒂芬 (Tom Stephan),Stifel。

  • Thomas Stephan - Equity Analyst

    Thomas Stephan - Equity Analyst

  • Great. Hey, guys. Thanks for taking the questions. Nice quarter.

    偉大的。嘿,大家好。感謝您回答這些問題。不錯的季度。

  • One, near-term, just on 2025 sales guidance, you beat Street and two Q1 revs by, I think, $8 million, $9 million but on the guide, you only raised by $3 million at the midpoint.

    首先,就短期而言,僅根據 2025 年的銷售指導,您的銷售額就比華爾街預期和第一季度的兩個季度高出 800 萬美元、900 萬美元,但根據指導,您在中期只籌集了 300 萬美元。

  • Tom, you made some comments on US Glaucoma and Corneal Health within the guide but, Tom or Joe, can you talk about the components of this year's revenue guide and then, maybe why more of the upside wasn't flushed through for the full year?

    湯姆,您在指南中對美國青光眼和角膜健康發表了一些評論,但是,湯姆或喬,您能否談談今年收入指南的組成部分,然後,也許為什麼全年沒有更多的上漲空間?

  • Joseph Gilliam - President, Chief Operating Officer

    Joseph Gilliam - President, Chief Operating Officer

  • Yeah. Tom, it's Joe. If Tom wants to (inaudible), he can.

    是的。湯姆,我是喬。如果湯姆想(聽不清楚),他可以。

  • Obviously, you did the math pretty quickly there. The fact is we're pleased to be able to be in a position to raise guidance off the back of what was an exceptional second quarter, as you noted. That was really driven by outperformance across the board but largely, by iDose, in particular.

    顯然,你很快就完成了計算。事實上,正如您所說,我們很高興能夠在第二季度表現出色的基礎上提高業績指引。這實際上是由整體表現優異所推動的,但很大程度上,尤其是由 iDose 所推動。

  • I think when you horseback some of the commentary from Tom -- and I'll elaborate a bit more -- you'll find that that really it was a full-beaten raise in the context of iDose, which is up to the core of the growth story as we sit here today.

    我認為,當你仔細閱讀湯姆的一些評論時——我會更詳細地闡述——你會發現,在 iDose 的背景下,這確實是一次全面的加薪,這是我們今天所討論的成長故事的核心。

  • But several data points as you think about updating your models for the second half of the year:

    但是,當您考慮更新下半年的模型時,請注意以下幾個數據點:

  • First, on the International Glaucoma side, obviously, we continue to be off to a strong start this year and has some currency benefit in the second quarter. We're now expecting that we'll have low-double digit growth for the remainder of the second half, on a year-over-year basis -- so largely unchanged there in terms of our expectations of our growing scale and competitive products launching key markets that present headwinds as we move forward, relative to, obviously, the strong first-half results.

    首先,在國際青光眼方面,顯然,我們今年繼續保持強勁開局,並在第二季度獲得了一些貨幣效益。我們現在預計,下半年剩餘時間我們的業績將同比實現低兩位數增長——因此,就我們不斷增長的規模和在主要市場推出競爭性產品而言,這些預期基本保持不變,而這顯然與上半年強勁的業績相比,對我們未來的發展構成了阻力。

  • On the Corneal side, Tom, I think elaborated on this, but I'll repeat it: when we go into the second half here, we enter a period with, I'll call it, less visibility or predictability as we navigate the transition from Photrexa to Epioxa, assuming the latter is approved as expected in October. So our current expectations are for flat to low -single-digit growth, if you will, in Q3, followed by a material disruption or headwind in Q4 as patients forego Photrexa in favor of Epioxa for all the reasons that Tom articulated.

    在角膜方面,湯姆,我認為已經詳細闡述了這一點,但我將重複一遍:當我們進入下半年時,我們將進入一個時期,我稱之為可見性或可預測性較低的時期,因為我們正在從 Photrexa 過渡到 Epioxa,假設後者在 10 月按預期獲得批准。因此,我們目前的預期是,第三季將保持平穩或低個位數成長,而第四季將出現重大中斷或逆風,因為患者出於 Tom 闡述的所有原因而放棄 Photrexa 轉而選擇 Epioxa。

  • That leaves you out to the US Glaucoma side where we continue to expect the same dynamics around the LCD headwinds and the Hydrus royalty expiration and then, the generation of probably a mid-single-digit decline for, I'll call it, the non-iDose revenues in the second half.

    這就把我們排除在美國青光眼方面,我們繼續預期 LCD 逆風和 Hydrus 特許權使用費到期方面將出現同樣的動態,然後,下半年非 iDose 收入可能會出現中等個位數的下降,我稱之為。

  • When you put all that together, it's going to imply continued sequential iDose expansion in Q3 and Q4 and an overall expansion of our expectations for the for the full year on the iDose front.

    綜合考慮所有這些因素,這意味著 iDose 將在第三季和第四季繼續連續擴張,並且我們對 iDose 全年的預期也將全面擴大。

  • Thomas Stephan - Equity Analyst

    Thomas Stephan - Equity Analyst

  • That's great. Appreciate that.

    那太棒了。非常感謝。

  • And then, now, I'm pivoting a bit more big picture, just on interventional glaucoma approaching 18 months into the iDose launch. I just wanted to ask about the state of the union with interventional glaucoma. What are the learnings, the puts-and-takes around those broader IG efforts?

    現在,我將把重點放在更宏觀的方面,即 iDose 推出 18 個月後介入性青光眼方面。我只是想詢問一下介入性青光眼的現況。在更廣泛的 IG 努力中,有哪些經驗教訓和付出?

  • And Joe or Tom, where does your bullishness stand in terms of the long-term opportunity with IG? Thanks.

    那麼喬或湯姆,就 IG 的長期機會而言,你們看好哪一方面?謝謝。

  • Joseph Gilliam - President, Chief Operating Officer

    Joseph Gilliam - President, Chief Operating Officer

  • Well, I can start off here. I'm sure Tom will have some views as well.

    好吧,我可以從這裡開始。我確信湯姆也會有一些看法。

  • Obviously, if you think about this as being part of the birthright of us as a company over the years -- but I'll start, Tom, by acknowledging some of the foundational work that that you recently did on this paradigm shift and I'm glad you asked the question. I think it was a good state-of-the-state snapshot but also a bit of indicator of how far we've come over the last 18 to 24 months, in terms of building the standalone market opportunity.

    顯然,如果您認為這是我們公司多年來與生俱來的權利的一部分——但湯姆,首先我要承認您最近在這種範式轉變上所做的一些基礎工作,我很高興您提出了這個問題。我認為這不僅是一個很好的現狀快照,而且還在一定程度上表明了我們在過去的 18 到 24 個月內在建立獨立市場機會方面取得了多大的進展。

  • Hopefully, you all have visibility and awareness of just how pronounced the shift in momentum towards interventional approach and to glaucoma care has changed since we began our efforts in support of it a year and a half ago.

    希望大家能夠清楚地認識到,自從我們一年半前開始努力支持介入方法和青光眼治療以來,介入方法和青光眼治療的勢頭發生了多麼顯著的變化。

  • The underlying movement, if you will, largely led by Glaukos in partnership with physicians to be proactive on behalf of patients now that tools like iDos3 TR and iStent infinite really enable a risk-benefit equation that makes sense is rapidly gaining traction.

    如果你願意的話,這項潛在的運動主要由 Glaukos 與醫生合作領導,代表患者採取積極主動的行動,因為現在像 iDos3 TR 和 iStent infinite 這樣的工具確實可以實現合理的風險收益等式,並且正在迅速獲得關注。

  • It's worth reminding investors what this means for, I'll call it, the next decade in ophthalmology as the 12 million to 13 million diagnosed and treated glaucoma eyes in the US also increasingly seek an interventional approach to care.

    值得提醒投資者的是,這對於眼科未來十年意味著什麼,因為美國有 1,200 萬到 1,300 萬被診斷和治療的青光眼患者也越來越多地尋求介入治療方法。

  • If you compare that to cataract surgery, which is the mainstay of our industry today that does about 5 million procedures annually, it's hard not to see how bright the future is for Glaukos and our industry, overall, as we improve the standard of care for patients.

    如果將其與白內障手術進行比較,白內障手術是當今我們行業的支柱,每年進行約 500 萬例手術,那麼隨著我們提高患者的護理標準,很難不看到 Glaukos 和我們整個行業的未來有多麼光明。

  • I have to give credit to our marketing team, our sales team, and the numerous other folks here at Glaukos that are driving this rapid change, from both the top down and the ground up, every day that's got us here.

    我必須對我們的行銷團隊、銷售團隊以及 Glaukos 的眾多其他員工表示感謝,是他們從上到下、從基層推動著這一快速變革,才讓我們走到了今天。

  • Thomas Stephan - Equity Analyst

    Thomas Stephan - Equity Analyst

  • That's great. Thank you.

    那太棒了。謝謝。

  • Operator

    Operator

  • Ryan Zimmerman, BTIG.

    Ryan Zimmerman,BTIG。

  • Ryan Zimmerman - Analyst

    Ryan Zimmerman - Analyst

  • Thanks for taking the questions. Congrats on the quarter. I appreciate you giving us the iDose number and removing the guesswork on that one.

    感謝您回答這些問題。恭喜本季。感謝您向我們提供 iDose 號碼並消除對此的猜測。

  • Maybe, just to start off with iDose for a second. You've made progress on certain MACs. And others are still not fully there, the best way to put it. Can you compare and contrast the geographies in which MACs are fully covering iDose without any disruption or any slowness? And how is the utilization amongst that physician base compared to, say, a territory or a state that's in a MAC that may not be fully there and your timelines and assumptions for when those ramp, Joe?

    也許,只是先從 iDose 開始。您在某些 MAC 上取得了進展。而其他人還沒有完全到達那裡,這是最好的說法。您能否比較和對比 MAC 完全覆蓋 iDose 且沒有任何中斷或緩慢的地區?那麼,與可能尚未完全實現 MAC 的地區或州相比,該醫生群體的利用率如何?喬,您對這些何時增加的時間表和假設是什麼?

  • Joseph Gilliam - President, Chief Operating Officer

    Joseph Gilliam - President, Chief Operating Officer

  • Yeah. Happy to touch on that, Brian. As you commented, we did disclose the [$31 million] approximate sales of iDose in the second quarter, which was a significant step in the right direction. And the performance really was driven by a mix and a continued mix of both new starts and increasing utilization within those accounts who've been at it for a bit now.

    是的。很高興談及這一點,布萊恩。正如您所說,我們確實揭露了第二季 iDose 的近似銷售額 [3,100 萬美元],這是朝著正確方向邁出的重要一步。而業績的真正推動力實際上是新開張和那些已經開張一段時間的帳戶的利用率不斷提高的混合和持續混合。

  • Really, to dive in, I, think, in the heart of some of your questions: while we saw growth nationwide in pretty much every geography, the acceleration continue to be faster in those (inaudible) regions where the professional fee has been established for a bit. That's really driven, again, by widening surge in adoption over the course of 2025 that began to translate into procedures, given the typical scheduling backlogs you see in ophthalmology -- and I know you know well.

    確實,我認為,深入探討一下你們提出的一些問題的核心:雖然我們看到全國幾乎所有地區都在增長,但在那些(聽不清楚)已經確定了專業費用的地區,增長速度仍然更快。這實際上是由 2025 年期間採用率的不斷增長所推動的,考慮到眼科中典型的排班積壓,這種採用率開始轉化為程序——我知道你很清楚。

  • To put that in the context, (inaudible), which are the MACs who've had a professional fee schedule in place for a little bit, they represent a little over 50% of Medicare lives, those regions. But we saw over 80% of our IDose volumes come from those areas in Q2. That's a growing percentage of the overall mix.

    具體來說,(聽不清楚)這些 MAC 已經制定了專業收費標準,它們代表了這些地區 50% 以上的醫療保險人口。但我們發現第二季超過 80% 的 IDose 銷量來自這些地區。這一比例在整體組合中不斷增長。

  • And so I think that the trend that goes well for our business as these other MACs finalize their iDose and professional fees, schedules here in the, hopefully, relatively near future.

    因此,我認為,隨著其他 MAC 在不久的將來最終確定其 iDose 和專業費用及時間表,這一趨勢對我們的業務有利。

  • The second part of your question was -- where do we go from here is the way I would summarize it. And I would just say that, all the MACs now appear to largely be paying the J-code properly, which is the first step in the journey, if you will; and continued progress that we've seen there.

    你的問題的第二部分是──我總結一下,我們接下來該做什麼。我只想說,現在所有 MAC 似乎都正確支付了 J 代碼,這是旅程的第一步,如果你願意的話;並且我們已經看到了持續的進展。

  • And as it relates to professional fee beyond (inaudible), we believe that that [NGS] has made considerable progress. We're seeing increasing momentum that makes us hopeful that in the relatively near term, we'll see a professional fee get established in what is the third largest map region in the United States.

    由於它與專業費用有關(聽不清楚),我們相信[NGS]已經取得了長足的進步。我們看到了日益增長的勢頭,這使我們有希望在相對較短的時間內,在美國第三大地圖區域建立專業費用。

  • We continue to make slow and, I'll call, it, methodical progress of [Palmetto] and WPS. We really accelerate our advocacy and education efforts, both at the account level but also with the MACs themselves. And we started to see the earliest signs of positive profile payment flow but there's still work to do in both of those important MACs.

    我們繼續緩慢地(我稱之為有條不紊地)推進 [Palmetto] 和 WPS 的進程。我們確實加快了我們的宣傳和教育力度,不僅在帳戶層面,而且在 MAC 本身。我們開始看到積極的個人資料支付流的最早跡象,但在這兩個重要的 MAC 方面仍有工作要做。

  • And then, really [CGS], I would say remains behind the others by a fairly considerable margin at this stage. And we are engaging directly with them and have been for some time. And eventually, it's the smallest MAC of all -- we do expect them to come around alongside the other MACs.

    然後,實際上 [CGS] 我想說,在現階段仍然落後於其他公司相當大幅度。我們正在與他們直接接觸,而這種接觸已經有一段時間了。最終,它是所有 MAC 中最小的——我們確實希望它能與其他 MAC 一起出現。

  • Ryan Zimmerman - Analyst

    Ryan Zimmerman - Analyst

  • That's very helpful, Joe. Just sticking on the topic of professional fees for a moment and turning to the legacy MIGS business. We all saw the proposals, I remember many years ago, doctors were making, I think, close to $1,000 to implant the mix. We're now pushing around [100], maybe [sub-100]. We'll see where the proposals land.

    喬,這很有幫助。我們先暫時聊聊專業費用,然後再談談遺留的 MIGS 業務。我們都看到了這些提議,我記得很多年前,醫生們植入這種混合物的費用大約是 1,000 美元。我們現在大概在[100]左右[低於100]。我們將拭目以待這些提議最終會如何實現。

  • My question is more of a bigger-picture question, though, on that topic, which is, as the pro fees have come down, how do you think about legacy surgical glaucoma and the broader appeal to, say, non-glaucoma ophthalmologists, the comprehensive ophthalmologist who maybe was your marginal customer, who was doing mix, as that comes down, does that get offloaded to the glaucoma specialists?

    不過,關於這個主題,我的問題更像是一個更大的問題,那就是,隨著專業費用的下降,您如何看待傳統的手術性青光眼以及對非青光眼眼科醫生、綜合眼科醫生(可能是您的邊際客戶,從事混合治療)的更廣泛吸引力,隨著費用的下降,這些費用是否會轉嫁給青光眼專家?

  • I'm just curious how you're thinking about maybe some of those economic incentives.

    我只是好奇您是如何看待這些經濟誘因的。

  • Joseph Gilliam - President, Chief Operating Officer

    Joseph Gilliam - President, Chief Operating Officer

  • Yeah. I think, Ryan, there's a couple of things to unpack in your statement. The first one is, to a large extent, professional fees are about relativity in the context of the economics for that surgeon's time, whether that be in the context of cataract surgery, mixed procedures, standalone procedures, or the like.

    是的。瑞安,我認為你的聲明中有幾點需要解釋。第一個是,在很大程度上,專業費用與外科醫生的時間經濟性有關,無論是在白內障手術、混合手術、獨立手術或類似手術中。

  • And as you heard Tom say -- and we know from the proposed rule, what you've seen across many therapeutic categories -- not just ophthalmology, but many others -- it certainly is across the board of ophthalmology in the wholesale shift in the way CMS is calculating the professional fee economics and our views that drive them.

    正如湯姆所說——我們從擬議的規則中知道,您已經在許多治療類別中看到了這一點——不僅僅是眼科,還有許多其他類別——CMS 計算專業費用經濟學的方式以及推動這一方式的觀點的全面轉變肯定是整個眼科領域的轉變。

  • And so I think there's an education process that has to happen led by the societies and the various groups that that have a voice with CMS to help make sure that lands in the right spot. But where we land on it, I think, was articulated by Tom in the prepared remarks.

    因此,我認為必須開展一個由社會各界和各團體主導的教育過程,這些團體對 CMS 有發言權,以幫助確保其到達正確的位置。但我認為,湯姆在準備好的發言中已經明確表達了我們的立場。

  • The reality of what we're seeing unfold only emboldens the move towards standalone glaucoma therapy as a pathway for the average practice to continue to remain financially viable as they move forward here and face that.

    我們所看到的現實只會鼓勵人們轉向獨立的青光眼治療,作為普通診所繼續保持財務可行性的途徑,因為他們會繼續前進並面對這個問題。

  • To put that historical statement in context, there was a point where cataract surgery (inaudible) were over $2,000 a procedure. And today, obviously, in the proposed ,rule they're in the [$400s]. Obviously, doctors continue to do cataract surgery as the ubiquitous standard of care for that disease indication.

    為了將這段歷史陳述放在背景中,曾經有一段時間,白內障手術(聽不清楚)每次的費用超過 2,000 美元。今天,顯然,在擬議的規則中,他們處於[400美元]。顯然,醫生們繼續將白內障手術作為治療疾病的普遍標準。

  • I think what you're going to see is more and more of those broader ophthalmologists leaning in to what we've been talking about, which is interventional glaucoma, paradigm shift, and starting to really treat these patients proactively as a part of both doing the right thing for the patient and the right thing for the practice.

    我認為你會看到越來越多的眼科醫生傾向於我們一直在談論的介入性青光眼、範式轉變,並開始真正主動地治療這些患者,作為對患者和實踐做正確事情的一部分。

  • Thomas Burns - Chairman of the Board, Chief Executive Officer

    Thomas Burns - Chairman of the Board, Chief Executive Officer

  • Well, I agree, as well. Ryan, this is Tom. You look at the recurring changes and reductions in fees that are happening as we've now seen over the last several years and in cataract surgery, we believe that's going to continue going forward.

    嗯,我也同意。瑞安,這是湯姆。正如我們在過去幾年中看到的那樣,費用不斷變化和降低,在白內障手術方面,我們相信這種情況將會持續下去。

  • I think not only do we have the immunization here on the current CMS provisions of Category III codes of really high-paying standalone payments for iDose and iStent infinite, I think as we go forward, these comprehensive ophthalmologists who, right now, are spending most of their time recruiting cataract patients for one-and-done procedures -- this is catch-and-release -- are going to start waking up to the value of looking at glaucoma as a long-term treatment pattern in what we're calling the forever patient.

    我認為,我們不僅對目前 CMS 規定的 III 類代碼(即為 iDose 和 iStent infinite 提供真正高薪的獨立支付)具有免疫力,而且我認為,隨著我們不斷前進,這些綜合眼科醫生(他們現在大部分時間都在招募白內障患者進行一次性手術 - 這就是抓到就放 - 他們將開始意識到將青光眼視為我們將開始意識到青光眼的價值。

  • With a forever patient now with a statutory time of 20-plus years from the time of diagnosis to leg termination, there will be multiple opportunities for these surgeons to re-enter and to reimplant with procedural pharmaceuticals and with stents. I think that will start to really resonate with these comprehensive ophthalmologists, not only as a more advanced standard of care for patients to stop the progression of glaucoma but as an offset to the chewing that's happening on the professional side for their cataract surgery procedures.

    現在,從診斷到終止腿部治療,永久患者有 20 多年的法定時間,這些外科醫生將有多次機會再次進入並重新植入程序藥物和支架。我認為這將真正引起這些綜合眼科醫生的共鳴,這不僅為患者提供了更先進的護理標準,以阻止青光眼的進展,而且也抵消了專業人士在白內障手術過程中的咀嚼。

  • Ryan Zimmerman - Analyst

    Ryan Zimmerman - Analyst

  • Yeah. Thank you for that complete answer there. Thank you.

    是的。感謝您的完整回答。謝謝。

  • Thomas Burns - Chairman of the Board, Chief Executive Officer

    Thomas Burns - Chairman of the Board, Chief Executive Officer

  • Welcome.

    歡迎。

  • Operator

    Operator

  • Allen Gong, J.P. Morgan.

    艾倫·龔,摩根大通。

  • Unidentified Participant

    Unidentified Participant

  • Hi. This is actually [Rohan], on for Alan. Thanks for taking the question.

    你好。這實際上是 [Rohan],代表 Alan。感謝您回答這個問題。

  • I just wanted to ask about the ramifications of the proposed reimbursement to start off, just the higher facility fee offsetting, the lower position fees. How are you thinking about that and the impact of that next year? And do you view it as more of a rising tide that lifts all these [folks]?

    我只是想問一下擬議的報銷的後果,首先是更高的設施費用抵消,較低的職位費用。您如何看待此事以及其明年的影響?你是否認為這更像是一股上升的潮流,將所有這些[夥計們]?

  • Just want to get a sense for how you're thinking about it.

    只是想了解一下你對此是怎麼想的。

  • Joseph Gilliam - President, Chief Operating Officer

    Joseph Gilliam - President, Chief Operating Officer

  • Yeah. I think you're talking about the proposed rule around the facility payments. Obviously, we're pleased to see those step up largely in line with the pace of inflation. I think, in general, that's a positive across the board for those folks who own and operate facilities and the manufacturers that provide tools and technologies and therapeutics into those facilities.

    是的。我認為您正在談論有關設施付款的擬議規則。顯然,我們很高興看到這些成長與通貨膨脹的速度基本一致。我認為,總的來說,這對於擁有和運營設施的人以及為這些設施提供工具、技術和治療方法的製造商來說都是一件好事。

  • I'm not sure I would call it out as a particular driver, if you think about the set-up for 2026. It's more of a neutral-but-slightly-positive event in the context of Glaukos and the other participants in the mix feel.

    如果你考慮 2026 年的設置,我不確定我是否會稱其為特定的驅動因素。在 Glaukos 和其他參與者的感受下,這更像是一個中性但略帶正面的事件。

  • Unidentified Participant

    Unidentified Participant

  • Thanks. Just a quick follow-up as well on SG&A. There was a fairly big step-up in the quarter, just want to get a sense for what's driving that, relative to expectations? And how are you thinking about SG&A growth for 2026? Is that 10% level still a good way to think about it or should we expect something a bit higher?

    謝謝。也只是對銷售、一般及行政費用 (SG&A) 進行快速跟進。本季出現了相當大的成長,只是想了解相對於預期而言,推動這一成長的因素是什麼?您如何看待 2026 年銷售、一般及行政費用的成長?10% 的水平是否仍然是一個好的思考方式,還是我們應該期待更高一點的水平?

  • Alex Thurman - Chief Financial Officer, Senior Vice President

    Alex Thurman - Chief Financial Officer, Senior Vice President

  • Hey, Rohan. This is Alex. Thanks for the question. It is a great question.

    嘿,羅翰。這是亞歷克斯。謝謝你的提問。這是一個很好的問題。

  • You're right. There was a little bit of a step-up in both SG&A and total OpEx year over year and during the quarter. We want to point out that within that number -- I'm going to speak to the total OpEx as a (inaudible) -- so within the total OpEx number, there's about a $4 million one-time stock comp expense hit that occurred based on the triggering of certain performance awards that happened during the quarter.

    你說得對。與去年同期相比以及本季度,銷售、一般及行政費用和總營運支出均略有增加。我們想指出的是,在這個數字中——我將把總營運支出稱為(聽不清楚)——因此在總營運支出數字中,由於本季度觸發了某些績效獎勵,產生了約 400 萬美元的一次性股票補償費用。

  • So if you exclude that and you look at that on an adjusted basis, the OpEx would have grown around 16%. And as we've guide guided in the in the past, we've always said our OpEx this year would grow in the mid-teens. So that's in line with what we spotted -- what we would have expected, excluding that stock comp expense.

    因此,如果排除這一點並在調整後的基礎上進行觀察,營運支出將增加約 16%。正如我們過去所指導的那樣,我們一直說今年的營運支出將成長百分之十幾。因此,這與我們發現的情況一致——我們的預期是一致的,不包括股票補償費用。

  • And then, if you think about it on a go-forward basis, again, speaking as a total OpEx, we would expect that third quarter to be roughly flat to our recorded second-quarter number; and then, the fourth quarter, maybe a sequential step-up from there.

    然後,如果你從未來的角度考慮,再次從整體營運支出的角度來說,我們預計第三季將與我們記錄的第二季數字大致持平;然後,第四季可能會出現連續的成長。

  • When you put all that together, you're looking at something for the full year in the $460 million range, which is more the top end of the range that we were thinking about previously. That, again, translates to about mid-teens growth year over year.

    如果把所有這些加在一起,那麼全年的收入將達到 4.6 億美元左右,這比我們之前考慮的範圍的最高值要高。這又意味著年復一年,成長率大約在十五六成左右。

  • Unidentified Participant

    Unidentified Participant

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Larry Biegelsen, Wells Fargo.

    富國銀行的拉里·比格爾森。

  • Unidentified Participant 2 - Analyst

    Unidentified Participant 2 - Analyst

  • Hi. This is (inaudible), on for Larry. Thanks for taking the questions here.

    你好。這是(聽不清楚),拉里。感謝您在這裡回答問題。

  • Just one, on guidance, any finer point on the cadence of sales in the back half. As I think about the color that you've provided around iDose and the different reimbursement updates with regards to the MACs, should we be thinking about an incremental step-up in Q3 and something that's a little bit more Q4-weighted? Just what would that exit rate imply for iDose beyond this year?

    只有一個指導,關於下半年的銷售節奏有任何更詳細的說明嗎?當我思考您提供的有關 iDose 的詳細資訊以及與 MAC 相關的不同報銷更新時,我們是否應該考慮在第三季度逐步增加,並在第四季度稍微增加一些權重?那麼,這項退出率對於今年以後的 iDose 來說又意味著什麼呢?

  • Joseph Gilliam - President, Chief Operating Officer

    Joseph Gilliam - President, Chief Operating Officer

  • Yeah. Hi, (inaudible). It's Joe. I've probably given sufficient color in the context of the second half in totality. Maybe the best way to answer the question around the, I'll call it, cadence from Q3 to Q4 is the -- dial in a bit on what you typically see in Q3.

    是的。你好,(聽不清楚)。是喬。我大概已經對下半場的整體狀況做了足夠的闡述。也許回答有關從 Q3 到 Q4 的節奏的問題的最好方法是——稍微了解一下你通常在 Q3 中看到的內容。

  • As you know, in ophthalmology (inaudible) in our business, Q3 tends to be a seasonally down quarter, just given summer holidays, on a global basis. And if I put a finer point on that in the context of our various franchises, the Corneal Health business tends to be flapped up a touch. But I think with lower device sales and some potential Epioxa- -- obviously -- related noise, as anticipation grows for that product approval, the way to probably think about that is sequentially being a bit flat to what we saw in in Q2 out of the Corneal business.

    如您所知,在我們的眼科業務中(聽不清楚),由於全球範圍內正處於暑假,第三季度往往是季節性下滑的季度。如果我在我們的各個特許經營權的背景下更詳細地說明這一點,那麼角膜健康業務往往會受到一些影響。但我認為,隨著設備銷量下降以及一些潛在的 Epioxa(顯然)相關的噪音,隨著對該產品批准的預期不斷增長,可能的考慮方式是,與我們在第二季度看到的角膜業務情況相比,情況會略有持平。

  • International Glaucoma usually takes a couple million dollars dollar step-down in Q3, relative to Q2. And then, it's like the US Glaucoma business, the non-iDose-related portion typically also takes a step-down of a couple million dollars from Q2 to Q3. But we would expect, obviously, some iDose offset there to put you back into positive territory, Q3 versus Q2, on the US Glaucoma.

    與第二季相比,國際青光眼在第三季的支出通常會減少數百萬美元。然後,就像美國青光眼業務一樣,與 iDose 無關的部分通常也會從第二季到第三季減少數百萬美元。但我們顯然希望,在美國青光眼領域,iDose 的一些抵消作用會將您帶回正值區域,Q3 對比 Q2。

  • You put all that together, I think where your model will land is sequentially down a bit, relative to Q2. And then, as often is the case in ophthalmology, Q4 obviously becomes the more important of the two, as we exit the year and a lot of procedures get done.

    把所有這些放在一起,我認為你的模型相對於第二季而言會下降一點。然後,正如眼科中經常出現的情況一樣,隨著我們結束這一年並完成了許多手術,第四季度顯然變得更重要。

  • Unidentified Participant 2 - Analyst

    Unidentified Participant 2 - Analyst

  • Okay. Great. That very helpful. Just for my follow-up, we do continue to hear from physicians in our surveys that a high percentage of iDose cases are done in combo cataracts. Can you share a national percentage with us? And how is that trending versus your expectations?

    好的。偉大的。這非常有幫助。僅就我的後續情況而言,我們在調查中確實不斷聽到醫生說,很大比例的 iDose 病例是在組合白內障中完成的。您能與我們分享全國的百分比嗎?與您的預期相比,趨勢如何?

  • Joseph Gilliam - President, Chief Operating Officer

    Joseph Gilliam - President, Chief Operating Officer

  • Yeah. I think there can be some noise in your sampling there, obviously. It's not something that we track closely nor are we able to. As you know, when a facility orders iDose at the end of that, there's no direct relationship to knowing whether or not they've done it in a combination of cataract surgery or not.

    是的。我認為你的採樣中顯然可能存在一些噪音。這不是我們密切追蹤的事情,我們也沒有能力追蹤它。如您所知,當醫療機構最終訂購 iDose 時,這與了解他們是否在白內障手術組合中進行了該手術沒有直接關係。

  • But having said that, we believe that the largest utilization continues to be in standalone procedures. And as reimbursement gets solidified, surgeons naturally start to look at it in both settings where -- meeting the patient where they're at, if they've got elevated pressure and they're looking to control that. Whether that patient has comorbidity with cataract or not, they're increasingly turning to iDose.

    但話雖如此,我們認為最大的利用率仍然是獨立程式。隨著報銷制度的鞏固,外科醫生自然會開始從兩個角度考慮這個問題——在患者所在的地方與他們會面,了解他們是否有血壓升高,並希望控制血壓。無論患者是否患有白內障,他們都越來越多地選擇使用 iDose。

  • So we would expect, certainly, over the intermediate period, a little higher percentage being done in combination with cataract surgery and, say, at the beginning or, certainly, as we think about it over the next, 3-, 5-, and 10-year period. But I wouldn't say that it's the dominant portion of what we're seeing today.

    因此,我們當然可以預期,在中期,與白內障手術相結合的治療比例會更高一些,例如在開始時,或者當然,在我們考慮未來 3 年、5 年和 10 年期間的情況時。但我不會說這是我們今天所見的主導部分。

  • Unidentified Participant 2 - Analyst

    Unidentified Participant 2 - Analyst

  • Great. Thank you.

    偉大的。謝謝。

  • Operator

    Operator

  • David Saxon, Needham.

    大衛‧薩克森,尼德姆。

  • David Saxon - Equity Analyst

    David Saxon - Equity Analyst

  • Great. Thanks for taking my questions. Congrats on the quarter. A couple for me. One on iDose. And then, I'll have one on Corneal Health.

    偉大的。感謝您回答我的問題。恭喜本季取得佳績。對我來說是一對。iDose 上有一個。然後,我將講一篇關於角膜健康的。

  • First, for iDose, specifically for the reimbursement, do you think we'll be at a place exiting the year where maybe six or all seven of the MACs are paying at the J-code with an established pro fee? And is there anything that needs to be done outside of just getting cases submitted for the four that are lagging to catch up?

    首先,對於 iDose,特別是對於報銷,您是否認為到今年年底,我們是否會有六個或全部七個 MAC 按照 J 代碼支付既定的專業費用?除了幫助那四個落後的國家提交案件外,還需要做些什麼嗎?

  • Joseph Gilliam - President, Chief Operating Officer

    Joseph Gilliam - President, Chief Operating Officer

  • Yeah. David, just -- I think, first of all, on the J-code itself, we're already largely seeing all of the MACs increasingly paying those as they should.

    是的。大衛,首先我認為,就 J 代碼本身而言,我們基本上已經看到所有 MAC 都在按應有的金額支付這些費用。

  • As it relates to professional fee, which I think is the heart of your question, it is, in large part, a volume game because what the MACs do is educate themselves on the procedure, the cost, and resource utilization associated with that. And as they get more data points, they're able then to arrive at the appropriate crosswalk and pricing of that Category III code. That's when they'll publish it.

    我認為這與專業費用有關,這在很大程度上是一場數量遊戲,因為 MAC 所做的就是了解與之相關的程式、成本和資源利用率。隨著他們獲得更多數據點,他們就能得出該類別 III 代碼的適當交叉口和定價。那時他們就會發布它。

  • I think, as I noted earlier in the call, we've made an awful lot of progress with virtually all the MACSs probably, with the lone exception being CGS. And so as I think about going forward, I certainly hope that that would be the case. I can only say that we'll be doing everything possible from an advocacy and education in driving those required volumes to get the MACs to a place where they feel comfortable pricing it in a manner similar to what we've seen obviously already out of (inaudible).

    我認為,正如我在電話會議早些時候提到的那樣,我們在幾乎所有 MACS 方面都取得了巨大進展,唯一的例外是 CGS。因此,當我考慮未來時,我當然希望情況會是這樣。我只能說,我們將盡一切可能,透過宣傳和教育來推動這些所需的數量,讓MAC達到他們感到舒適的定價水平,就像我們已經看到的那樣(聽不清楚)。

  • David Saxon - Equity Analyst

    David Saxon - Equity Analyst

  • Okay. Great. Thanks for that. And then, on Corneal Health. After Epioxa is approved, how are you thinking about rolling out the Epioxa cross-linking machine? I understanding it's going to be a different machine. So is that a trade-in? Is it a new purchase? And then, over what period of time would you expect installed based to convert over to the new machine?

    好的。偉大的。謝謝。然後,討論角膜健康。Epioxa 獲得批准後,您打算如何推出 Epioxa 交聯機?我知道這將會是一台不同的機器。那麼這是以舊換新嗎?是新買的嗎?那麼,您預計在多長時間內已安裝的機器會轉換為新機器?

  • Joseph Gilliam - President, Chief Operating Officer

    Joseph Gilliam - President, Chief Operating Officer

  • Yeah. It's a good question, David. I'm not going to get too deep into the particulars, obviously, certainly, in advance of an approval in hand. I think when we get to that point, we'll give a lot more context.

    是的。這是個好問題,大衛。顯然,在獲得批准之前,我不會太深入地討論細節。我認為當我們達到這一點時,我們會提供更多的背景資訊。

  • But you raised one of many pertinent points around what will be the roll-out and transition period from Photrexa as the standard of here today, what we expect with Epioxa.

    但您提出了許多中肯的觀點之一,即從 Photrexa 開始的推出和過渡期是怎樣的,作為今天的標準,我們對 Epioxa 有何期待。

  • As you heard Tom mention in the prepared remarks, we do expect an impact from those that transition over the course of, certainly, this fourth quarter and into early next year. Part of which is driven by what you're describing around getting the new system installed out there.

    正如湯姆在準備好的發言中提到的那樣,我們確實預計這些轉變將在今年第四季和明年年初產生影響。其中一部分是由您所描述的有關安裝新系統所驅動的。

  • But, really, the biggest driver of this is going to be simply the fact that most patients who are educated on the relative differences of the non-invasive, procedure alternative that exists with Epioxa aren't going to want to defer to the extent they can to get access to what is a superior procedure, from a patient perspective.

    但實際上,造成這種情況的最大驅動因素只是這樣一個事實:大多數了解 Epioxa 的非侵入性替代治療的相對差異的患者,從患者的角度來看,並不願意盡可能地推遲接受更優的治療。

  • And so we do expect there to be a bit of that, I'll call it, warehousing of patients, post-approval, until we're really fully up and running, both from a sight-of-care perspective with the machines as you're describing, as well as a patient access perspective from a reimbursement standpoint.

    因此,我們確實希望在獲得批准後,有一點我稱之為患者倉儲的情況,直到我們真正全面啟動和運行,既從您所描述的機器的現場護理角度來看,也從報銷的角度來看患者訪問角度來看。

  • David Saxon - Equity Analyst

    David Saxon - Equity Analyst

  • Okay. Great. Thanks so much.

    好的。偉大的。非常感謝。

  • Operator

    Operator

  • Joanne Wuensch, Citi.

    花旗銀行的 Joanne Wuensch。

  • Joanne Wuensch - Analyst

    Joanne Wuensch - Analyst

  • Good evening. Thank you for taking the question.

    晚安.感謝您回答這個問題。

  • I'm catching up here a little bit with others reporting so forgive me. But did you comment on the full-year guidance for iDose based on what you are seeing in the market at this stage?

    我在這裡稍微了解了一下其他人的報告,所以請原諒我。但是,根據您目前看到的市場情況,您是否對 iDose 的全年業績預期發表了評論?

  • And then, for my second question, as we start to think about the Epioxa approval, how do you start to think about when that revenue may begin to ramp and to your point, if patients are putting the procedure off until it is available? Is there a wait list that's starting or is that too early?

    然後,對於我的第二個問題,當我們開始考慮 Epioxa 的批准時,您如何開始考慮何時收入可能會開始增加,以及您所說的,如果患者推遲手術直到藥物可用?是否有正在開始的等候名單,或者是否太早了?

  • Thank you so much.

    太感謝了。

  • Joseph Gilliam - President, Chief Operating Officer

    Joseph Gilliam - President, Chief Operating Officer

  • Yeah. Hi, Joanne. First, on the iDose guide and a bit of a (inaudible) and you'll be able to see it in, I think, the remark, as they become available. But, really, the punch line on iDose is as you weave your way through the second half across the various franchises, there's an implied -- obviously, it was the predominant part of the [beat] in the second quarter.

    是的。你好,喬安妮。首先,在 iDose 指南和一些(聽不清楚)上,當它們可用時,您將能夠在評論中看到它。但實際上,iDose 的妙處在於,當你在下半場穿越各個球隊時,你會發現一個隱含的——顯然,這是第二節比賽的主導部分。

  • And, really, on the heels of that, we've effectively raised our guidance for the full year around iDose. And we continue to see that growing momentum that you would hope for around the utilization of that; in particular, in those regions where the professional fee has been established in (inaudible).

    事實上,在此之後,我們實際上已經提高了對 iDose 全年的指導。我們繼續看到你所希望的利用這一優勢的成長勢頭;特別是在那些已經建立專業費用的地區(聽不清楚)。

  • As it relates to the Epioxa approval, I think, from a big-picture standpoint, there's a series of things that have to take place to where you're really running with any new drugs. Certainly in a rare disease category like (inaudible).

    至於 Epioxa 的批准,我認為,從宏觀角度來看,必須進行一系列的事情才能真正開始使用任何新藥。當然,在罕見疾病類別中,例如(聽不清楚)。

  • As we make our way through 2026, we expect to methodically unlock some of those. An important moment along that journey is the establishment of a J-code which we would expect in mid-year. But even through the course of the year, you're educating, in this case, commercial payers; you're updating policies; you're doing all the blocking and tax to get access for patients to a therapy that clearly they're going to want over the prior standard of care in the form of Photrexa.

    隨著我們邁入 2026 年,我們期望有條不紊地解開其中的一些難題。這趟旅程中的一個重要時刻是 J 代碼的建立,我們預計該代碼將在年中建立。但即使在一年的時間裡,你也在教育商業付款人;你正在更新政策;你正在採取一切阻止和徵稅措施,讓患者獲得他們顯然想要的治療方法,而不是像以前那樣以 Photrexa 形式接受標準治療。

  • The last thing I think you referenced -- no, there wouldn't be any formal wait lists, at this point. You don't have an approved process. And so those conversations aren't really happening. Certainly not on behalf of Glaukos or our organization in any way, shape, or form.

    我認為您提到的最後一件事是——不,目前還沒有任何正式的等候名單。您沒有獲得批准的流程。所以這些對話其實並沒有發生。當然不以任何方式、形式代表 Glaukos 或我們的組織。

  • It's possible that some surgeons -- just simply because of the public nature of the trial or their involvement in it -- would be having some conversations with patients. But I'd say that's probably on the margin at this point.

    一些外科醫生可能會與患者進行一些交談,只是因為試驗的公開性質或他們參與其中。但我想說,目前這可能還只是邊緣狀況。

  • It is something we expect to be an important dynamic that will play out, post-approval. So as you make your way through, call it, November and December in the fourth quarter, you can expect that that an increasing percentage of those patients will be having exactly that conversation with their physician.

    我們預計這將成為批准後發揮的重要作用。因此,當你進入第四季的 11 月和 12 月時,你可以預期會有越來越多的病人與他們的醫生進行這樣的對話。

  • We expect a significant portion of who can will try to defer and get access to Epioxa, just simply given the pain and the recovery time associated with Photrexa versus Epioxa.

    我們預計,很大一部分患者會嘗試推遲使用 Epioxa,而這只是因為與 Epioxa 相比,Photrexa 會帶來疼痛和恢復時間。

  • Joanne Wuensch - Analyst

    Joanne Wuensch - Analyst

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Adam Maeder, Piper Sandler.

    亞當梅德、派珀桑德勒。

  • Adam Maeder - Senior Research Analyst

    Adam Maeder - Senior Research Analyst

  • Good afternoon. Thank you for taking the questions. Congrats on the quarter.

    午安.感謝您回答這些問題。恭喜本季取得佳績。

  • Two for me, both on iDose. I'll ask them upfront. First, on the reimplantation decision from FDA, if I heard in the prepared remarks correctly, it's early 2026. I thought before it was potentially before year end. So did we have a little bit of a wiggle there? And if so, why the change in timing?

    我有兩個,都是在 iDose 上。我會提前問他們。首先,關於 FDA 的再植入決定,如果我沒有聽錯的話,應該是 2026 年初。我之前以為這可能發生在年底之前。那我們是不是有點搖擺不定呢?如果是這樣,為什麼時間會改變?

  • And then, secondly, for iDose TR and the in-office opportunity, can you just put a finer point on timelines there and what needs to be done to unlock the office opportunity for iDose?

    其次,對於 iDose TR 和辦公室機會,您能否更詳細地說明時間表,以及需要做些什麼才能解鎖 iDose 的辦公室機會?

  • Thanks for taking the questions.

    感謝您回答這些問題。

  • Thomas Burns - Chairman of the Board, Chief Executive Officer

    Thomas Burns - Chairman of the Board, Chief Executive Officer

  • Yeah. Adam, this is Tom. I'll be happy to take both those questions.

    是的。亞當,這是湯姆。我很樂意回答這兩個問題。

  • First of all, on the FDA's position with regards to iDose reimplantation, the wiggle, as you'd call it there, was the FDA recently classified our petition as an NDA supplement. And so with that, they gave us a PDUFA date, which followed the statutory guidelines that they've set, which is now January 28, 2026, which gives us certainty now for understanding what the position will be.

    首先,關於 FDA 對 iDose 再植入的立場,正如你所說的那樣,FDA 最近將我們的請願書歸類為 NDA 補充。因此,他們給了我們一個 PDUFA 日期,該日期遵循了他們設定的法定準則,現在是 2026 年 1 月 28 日,這讓我們現在可以確定情況將會如何。

  • And so while we believe we've made a compelling case for reimplantation, as I've said in the past, I just want to alert the investment community that we are not at all counting on a positive outcome. It would be a very formal upside if we were able to have a positive outcome on the iDose reimplantation discussions.

    因此,儘管我們相信我們已經為重新植入提出了令人信服的理由,但正如我過去所說的那樣,我只是想提醒投資界,我們根本不指望取得積極的結果。如果我們能夠在 iDose 再植入討論中取得積極成果,那將是一個非常正式的好處。

  • Secondly, with regards to TR. I think, first, it's important to note that we've already demonstrated that in our patient subset of a Phase III clinical trial. We stratified and we did a number of patients in-office using the current iDose applicator and iDose device in an in-office setting.

    其次,關於TR。我認為,首先,值得注意的是,我們已經在 III 期臨床試驗的患者子集中證明了這一點。我們進行了分層,並在辦公室環境中使用目前的 iDose 塗藥器和 iDose 設備對一些患者進行了治療。

  • Those data, we are now stratifying and we are pulling together for a submission for a peer-reviewed publication, as we speak. And we think they will replicate the safety and efficacy of iDose implantations that are done in the ASC.

    我們現在正在對這些數據進行分層,並將其匯總起來,提交給同行評審的出版物。我們認為它們將複製在 ASC 中進行的 iDose 植入的安全性和有效性。

  • We are currently in the process of initiating discussions with MACs, as I've talked about before, with the intention of creating a non-facility payment code, which will allow for the reimbursement of iDose implantation in an in-office settings. And as I've stated previously, this will likely be a several-months-long process.

    正如我之前談到的,我們目前正在與 MAC 展開討論,目的是創建一個非設施支付代碼,以便在辦公室環境中報銷 iDose 植入費用。正如我之前所說,這可能是個長達數月的過程。

  • With regards to iDose TR itself, we've gone through several enhancements of the of the improved iDose applicator. We continue to optimize the final engineering design. As I've said before, we're designing this new approach with the with the existing iDose device.

    就 iDose TR 本身而言,我們對改良的 iDose 塗抹器進行了多項改進。我們不斷優化最終的工程設計。正如我之前所說,我們正在利用現有的 iDose 設備設計這種新方法。

  • The applicator will target an approximately 1-millimeter incision. And by doing so, it should allow us to perform a closed-chamber procedure, which can maintain chamber pressure and minimize the essence of aqueous humor -- and that's aqueous humor that would percolate out during the procedure.

    塗抹器將瞄準約 1 毫米的切口。透過這樣做,我們可以進行閉腔手術,從而維持腔內壓力並最大限度地減少房水的含量——也就是手術過程中滲出的房水。

  • We have a final design, which is now targeted to enter a US clinical trial by year end. And while the design itself and the clinical trial is relatively short, the FDA has asked us to perform some additional testing over the period of one year. So we'll now be targeting the approval of the iDose TR by year in 2027.

    我們已經有了最終的設計,目前的目標是在年底前進入美國臨床試驗。雖然設計本身和臨床試驗相對較短,但 FDA 要求我們在一年內進行一些額外的測試。因此,我們現在的目標是在 2027 年之前批准 iDose TR。

  • Let me just say this new product made is a transition for surgeons to in-office surgery, particularly as we establish non-facility payment codes at each of the individual MACs. It is the first of what I anticipate will be many development efforts that we'll be making to optimize in-office implantation of iDose.

    我只想說,這種新產品是外科醫生向辦公室手術的過渡,特別是當我們在每個單獨的 MAC 上建立非設施支付代碼時。我預計,我們將進行多項開發工作,以優化 iDose 的辦公室內植入,這只是其中的第一步。

  • And I think the development of this product, as well as our subsequent products, comes at an enviable time. As we think about the recurring reduction of cataract surgical fees, the future capacity constraints of AFCs and the accelerating the demographic patient demands of IG procedures are continually driving surgeons to perform in -office implantation.

    我認為這款產品以及我們後續產品的開發恰逢其時。當我們考慮白內障手術費用的反覆降低時,AFC 未來的容量限制以及 IG 手術的人口患者需求的加速增長正在不斷推動外科醫生在辦公室內進行植入。

  • So back to Tom's initial question, where are we going? We have incredible standalone opportunity in front of us. We are driving and creating a new marketplace, just like we've done previously in creating the global mix marketplace. We intend to do so as we go forward in the future.

    那麼回到湯姆最初的問題,我們要去哪裡?我們面前有令人難以置信的獨立機會。我們正在推動和創建一個新的市場,就像我們之前創建全球混合市場一樣。我們打算在未來繼續這樣做。

  • It will be led, spearheaded by procedural pharmaceuticals and by our (inaudible) combinations. And I would say, as well, as you think about where this could go, I do believe that people will look for multiple mechanisms with single implantations. So we'll see surgeons, as they already are in the real world, starting to put in iDose with the iStent infinite or even a competitive product to be able to reduce target pressures where they can arrest the progression of glaucoma.

    它將由程序性藥物和我們的(聽不清楚)組合引領和帶動。我想說的是,當你思考這會走向何方時,我確實相信人們會尋找單一植入的多種機制。因此,我們將看到外科醫生,就像在現實世界中一樣,開始將 iDose 與 iStent infinite 甚至競爭產品一起使用,以降低目標壓力,從而阻止青光眼的進展。

  • So I think we have an incredible opportunity in front of us. The implantation over the next 5 to 10 years will be an accelerant to get to the surgeons and patients to where I think they deserve to go.

    所以我認為我們面前有一個難以置信的機會。未來 5 到 10 年的植入將成為幫助外科醫生和患者達到我認為他們應該達到的程度的加速器。

  • Adam Maeder - Senior Research Analyst

    Adam Maeder - Senior Research Analyst

  • It's a great color. Thanks, Tom.

    顏色很棒。謝謝,湯姆。

  • Thomas Burns - Chairman of the Board, Chief Executive Officer

    Thomas Burns - Chairman of the Board, Chief Executive Officer

  • You're welcome.

    不客氣。

  • Operator

    Operator

  • Richard Newitter, Truist Securities.

    Truist Securities 的 Richard Newitter。

  • Richard Newitter - Analyst

    Richard Newitter - Analyst

  • Thank you for taking the question.

    感謝您回答這個問題。

  • Just the first one, I was wondering if you could characterize the utilization trends or, really, anything, any behavior you're noticing in situations where the pro fee is established by MACs and without; and if you could specifically talk that everything from doc training, if you're noticing more docs getting trained or accelerating doc training in those situations or regions to whether or not you're seeing combo cataract use potentially differ in pro fee on or pro fee-established situations.

    只是第一個問題,我想知道您是否可以描述一下使用趨勢,或者實際上,在專業費用由 MAC 確定和非由 MAC 確定的情況下,您注意到的任何行為;並且您是否可以具體談談從醫生培訓到醫生培訓的一切,如果您注意到在這些情況或地區有更多的醫生接受培訓或加速醫生培訓,以及您是否看到專業費用組合在白內障的使用情況下可能有所確定或加速。

  • And then, if you could also characterize the utilization differences between the national average and the regions where you have a pro fee.

    然後,如果您還可以描述全國平均水平和收取專業費用的地區之間的利用率差異。

  • Thank you.

    謝謝。

  • Joseph Gilliam - President, Chief Operating Officer

    Joseph Gilliam - President, Chief Operating Officer

  • Richard, some of this will be a bit of a rehash from earlier in the call but I'm happy to do it, as you think about what's going on. I think the most important overall statement and it's evidence of giving many of the answers to the questions you asked is the continued acceleration in (inaudible) that is exceeding that of the overall country.

    理查德,其中一些內容可能與通話早些時候的內容有些重複,但我很樂意這樣做,因為你正在思考正在發生的事情。我認為最重要的總體陳述以及它對你提出的許多問題給出答案的證據是(聽不清楚)的持續加速,超過了全國整體的加速。

  • So when you think about the performance that we just had in the second quarter and the fact that 50% of the Medicare lives are represented in those three MACs where you have an established professional fee, we saw over 80% of our iDose volumes come from those areas in Q2. That's a percentage that's actually been increasing in recent quarters.

    因此,當您考慮到我們在第二季度的業績以及 50% 的醫療保險覆蓋範圍涵蓋這三個已確定專業費用的 MAC 這一事實時,我們發現第二季度超過 80% 的 iDose 銷售來自這些地區。事實上,這一比例在最近幾個季度一直在增加。

  • The momentum there is driven by virtually everything that you just asked. So we see a faster pace of doctor training and onboarding. We see overall increased utilization at an increasing number of accounts, where they move past trying-and-trialing and they start going into the full adoption mode, at least within the Medicare fee for service arena.

    那裡的勢頭幾乎是由您剛才問到的所有事情所驅動的。因此,我們看到醫生培訓和入職的速度加快了。我們看到,越來越多的帳戶的整體利用率正在提高,它們不再只是嘗試,而是開始進入全面採用模式,至少在醫療保險服務收費領域是如此。

  • And we also see a widening of how they utilize it. In the early days, to minimize both clinical distraction as well as reimbursement distraction, we really mandate that they do these in standalone procedures. And as they get their sea legs on both of those fronts, you see them start to expand into not just standalone procedures but also, utilizing it in combination of cataract surgery, really based upon the need for treating the glaucoma, irrespective of whether that patient has a cataract or not.

    我們也看到他們利用它的方式正在不斷擴大。在早期,為了盡量減少臨床幹擾和報銷幹擾,我們確實要求他們在獨立的程序中完成這些工作。隨著他們在這兩個方面站穩腳跟,你會看到他們開始擴展到不僅僅是獨立的手術,而且還將其與白內障手術結合使用,這實際上是基於治療青光眼的需要,而不管患者是否患有白內障。

  • So I would tell you that in virtually every KPI or metric you might look at, those regions that are contained within (inaudible), you're seeing outperformance, relative to the other areas of the country.

    因此,我想告訴您,在您可能看到的幾乎每一個 KPI 或指標中,那些包含在(聽不清楚)內的地區,相對於該國其他地區,您會看到其表現優異。

  • Richard Newitter - Analyst

    Richard Newitter - Analyst

  • That's really helpful. Just a quick follow up -- thanks for the sequential color 2Q to 3Q and then, 3Q to 4Q. I just want to clarify, did you say that US Glaucoma would be up quarter over quarter, 2Q to 3Q, where iDose is obviously up sequentially and core or non-iDose is down? And that that's out to positive? Just, what's the directional trend on US Glaucoma, quarter over quarter?

    這真的很有幫助。只是一個快速的跟進——感謝從 2Q 到 3Q 以及從 3Q 到 4Q 的連續顏色。我只是想澄清一下,您是否說過美國青光眼的銷售額會逐季上升,從第二季度到第三季度,iDose 的銷售額明顯環比上升,而核心或非 iDose 的銷售額則下降?那是積極的嗎?那麼,美國青光眼的季度環比趨勢如何?

  • Joseph Gilliam - President, Chief Operating Officer

    Joseph Gilliam - President, Chief Operating Officer

  • Yeah. I can confirm that. Obviously, procedure volumes in the third quarter are down, right? Physicians are on vacation. There's a lot less activity in the third quarter than in the second. That's generally always been the case, at least certainly over recent years.

    是的。我可以證實這一點。顯然,第三季的手術量下降了,對嗎?醫生們正在休假。第三季的活動比第二季少很多。總體而言,情況一直如此,至少近年來是如此。

  • We do -- what we've seen in prior years is that non-iDose business, if you will, down a couple million dollars, which we would expect to get iDose offset. And I think that should put us back into the positive category on a sequential basis for the US Glaucoma franchise.

    我們確實——我們在前幾年看到的情況是,非 iDose 業務下降了幾百萬美元,我們預計 iDose 業務將獲得抵消。我認為這應該會讓我們在美國青光眼特許經營領域連續重回積極類別。

  • Operator

    Operator

  • Michael Sarcone, Jefferies.

    薩科內(Michael Sarcone),傑富瑞集團。

  • Michael Sarcone - Analyst

    Michael Sarcone - Analyst

  • Good afternoon. Thanks for taking the question.

    午安.感謝您回答這個問題。

  • Just had a follow up on the US iStent business. Looks like it might have declined about 10% in the second quarter. Joe, I think, in your walkthrough for 2H, you mentioned maybe mid-single-digit declines.

    剛剛跟進了美國 iStent 業務。看起來第二季可能下降了約 10%。喬,我認為,在你對下半年的演練中,你提到了可能是中等個位數的下降。

  • I don't know if I'm splitting hairs here but what trends would occur where that performance would improve somewhat off of a high-single-digit, low-double-digit decline in 2Q?

    我不知道我是否在這裡吹毛求疵,但會出現什麼樣的趨勢,使得業績在第二季度高個位數、低兩位數的下滑之後有所改善?

  • Joseph Gilliam - President, Chief Operating Officer

    Joseph Gilliam - President, Chief Operating Officer

  • Yeah. It's a good question, Michael. I'd say there's two things going on there.

    是的。這是個好問題,麥可。我想說那裡發生了兩件事。

  • The first one is when you land at the 10%, there's probably a little bit of false precision around the division of what was non-iDose versus iDose, even in the comparable period last year, the second quarter of 2024. I'll just reiterate what we said, which is, I think the combined iStent plus expiration of the Hydrus royalty impact -- with a high-single-digit year-over-year impact.

    第一個問題是,當你達到 10% 時,非 iDose 與 iDose 的劃分可能存在一些錯誤的精度,即使在去年同期,即 2024 年第二季度也是如此。我只想重申我們所說的,那就是,我認為 iStent 加上 Hydrus 特許權使用費到期的影響——與去年同期相比將產生高個位數的影響。

  • Now, you raised a good point around the Q2 trend. We had anticipated that that Q2 was going to represent the peak of the headwind, if you will. We even when we sent guidance last quarter. We had made that assumption when we talked about the full year being in that mid-single-digit headwind area. And so the reason for that is there was a little bit of -- it was a tougher comp, if you will, in the second quarter, given some of the dynamics and ordering patterns that happened in Q2 of last year -- the non iDose business that -- the ease as we go forward here.

    現在,您就第二季的趨勢提出了一個很好的觀點。如果你願意的話,我們已經預料到第二季將代表逆風的頂峰。我們甚至在上個季度發送了指導。當我們談到全年將處於中位數個位數逆風區域時,我們做出了這樣的假設。原因在於,考慮到去年第二季度發生的一些動態和訂購模式,第二季度的競爭會更加激烈,非 iDose 業務的競爭會更加激烈,我們在此向前推進時會更加輕鬆。

  • And we're seeing some of those trends play out already as we make our way here through July. So I think we're confident that we've seen the peak of that headwind. And as we think about the remainder of the year, it should go back down to something that's in that mid-single digits, both for Q3 and Q4 as a headwind.

    隨著七月的到來,我們已經看到一些趨勢正在顯現。因此,我認為我們有信心我們已經看到了逆風的頂峰。當我們考慮今年剩餘時間的情況時,它應該會回落到中等個位數的水平,對於第三季和第四季來說都是一個阻力。

  • Michael Sarcone - Analyst

    Michael Sarcone - Analyst

  • Got it. That's really helpful, Joe. And then, maybe a quick follow up. I think in some of the prepared remarks at the opening of the call, you had mentioned (inaudible) some of the investments made. In 2Q, you might have generated about $4 million of cash from operations.

    知道了。喬,這真的很有幫助。然後,也許可以快速跟進。我認為在電話會議開始時的一些準備好的發言中,您提到了(聽不清楚)所做的一些投資。在第二季度,您可能從營運中產生了約 400 萬美元的現金。

  • Just wanted to dig a little deeper there. And on an underlying basis, how are you thinking about cash flow generation in the near and midterm?

    只是想深入挖掘一下。從根本上來說,您如何看待近期和中期的現金流產生?

  • Alex Thurman - Chief Financial Officer, Senior Vice President

    Alex Thurman - Chief Financial Officer, Senior Vice President

  • Hey, Mike. It's Alex. I'll take that one. Just to give you a little more flavor on the cash for the quarter and what Tom was saying in his prepared remarks, if you look at the change in cash between the end of the last quarter and the end of this quarter, that change was actually a decline of about $25 million.

    嘿,麥克。是亞歷克斯。我要那個。只是為了讓您更多地了解本季度的現金情況以及湯姆在準備好的發言中所說的內容,如果您查看上個季度末和本季度末之間的現金變化,就會發現該變化實際上下降了約 2500 萬美元。

  • But as Tom mentioned in his remarks, there were two transactions that occurred in the quarter. The first was the purchase of a building adjacent to our headquarters and the second was the acquisition of Mobius Therapeutics. The sum of those is about $30 million.

    但正如湯姆在演講中提到的那樣,本季發生了兩筆交易。第一個是購買我們總部附近的一棟建築,第二個是收購 Mobius Therapeutics。這些總額約為3000萬美元。

  • So when you take that and take that out of the negative [$25 million], you end up -- it's actually $29 million -- so you end up around a plus [4] or [4.5] of cash generation in the quarter. And that's the details around that.

    因此,當你把這個數字從負數 [2500 萬美元] 中減去時,你最終得到的結果是 — — 實際上是 2900 萬美元 — — 所以你最終會得到本季度現金產生的正數 [4] 或 [4.5]。這就是有關此事的詳細資訊。

  • As we think about going forward, again, we continue to have the near-term goal to manage our business such that we march towards cash flow breakeven or maybe small amounts of cash flow generation. Our goal continues to strike the right balance between our revenues and cash generation against the investments needed in both our new product launches and our rich pipeline that you heard about as well in Tom's prepared remarks.

    當我們考慮未來時,我們再次重申,我們將繼續以近期目標來管理我們的業務,以便我們朝著現金流盈虧平衡或可能產生少量現金流的方向前進。我們的目標仍然是在收入和現金產生與新產品發布和豐富產品線所需的投資之間取得適當的平衡,您在湯姆的準備好的演講中也聽到了這一點。

  • Joseph Gilliam - President, Chief Operating Officer

    Joseph Gilliam - President, Chief Operating Officer

  • I think it's also worth adding that with iDose growth clearly comes -- as we have elongated terms as you expect with any new product launch - and so as we make our way through and you see this, there's a lag effect there to the cash flow benefit; the earliest of which you're starting to see obviously in the Q2 period that Alex was just talking about.

    我認為還值得補充的是,iDose 的成長顯然是——正如您對任何新產品發布的預期那樣,我們延長了銷售期限——因此,隨著我們不斷前進,您會看到,現金流收益存在滯後效應;最早您開始看到的是 Alex 剛才談到的第二季度。

  • Michael Sarcone - Analyst

    Michael Sarcone - Analyst

  • Really helpful. Thank you.

    真的很有幫助。謝謝。

  • Operator

    Operator

  • Mason Carrico, Stephens.

    梅森·卡里科,史蒂芬斯。

  • Mason Carrico - Equity Analyst

    Mason Carrico - Equity Analyst

  • Hey. Thanks for fitting me in here. I'll ask my two upfront, if that's easier here.

    嘿。謝謝你讓我來這裡。如果這樣比較容易的話,我會提前問我的兩個孩子。

  • When it comes to commercial payers, what are your expectations around how iDose is implemented into those coverage policies? Is there an opportunity for it to be incorporated first-line? Should we be thinking about it as second- or third-line, potentially?

    對於商業付款人,您對 iDose 如何實施到這些保險政策中有何期望?它是否有機會成為一線產品?我們是否應該將其視為第二線或第三線?

  • And then, as a second question, could you give us some insight into where iDos3 margins stand today? Has that product become accretive to overall corporate gross margins? Thanks.

    然後,作為第二個問題,您能否向我們介紹一下 iDos3 目前的利潤率是多少?該產品是否對企業整體毛利率有所提升?謝謝。

  • Joseph Gilliam - President, Chief Operating Officer

    Joseph Gilliam - President, Chief Operating Officer

  • Yeah. Mason, I'll start off. And then, Alex can answer the latter for the second question there.

    是的。梅森,我先走了。然後,Alex 就可以回答第二個問題的後者了。

  • The good news is on the commercial payer policies, we actually have a pretty high number of policies that we can point to in support of this (inaudible). In fact, both on the commercial policy standpoint as well as Medicare Advantage, over 50% of lives have a positive policy in place today. And the vast majority of the remainder are silent. Every day that goes by, we're adjudicating claims within those environments to get confident that that patients can have access with those policies or those plans.

    好消息是,關於商業付款人政策,我們實際上有相當多的政策可以支持這一點(聽不清楚)。事實上,無論從商業政策角度還是從醫療保險優勢計劃角度來看,如今超過 50% 的人都享有積極的政策。其餘絕大多數人都保持沉默。每天,我們都在這些環境中裁決索賠,以確保患者能夠享受這些政策或計劃。

  • The reality of the existing policy framework is the majority have iDose is either a second- or third-line procedure. And it's entirely consistent with (inaudible) that obviously has been approved for a couple of years now. And so, really, the policies themselves will differ, often requiring failure, either on a single medication or two medications or a single medication in some form of an intervention prior to turning to iDose.

    現有政策框架的現實情況是,大多數人接受 iDose 治療都是第二線或三線治療。這與(聽不清楚)完全一致,顯然已經批准了幾年了。因此,實際上,政策本身會有所不同,通常要求在轉向 iDose 之前,以某種形式的干預措施,對一種藥物、兩種藥物或一種藥物進行治療失敗。

  • That's okay for us, obviously, out of the gate, if we're if we're launching the product. But you can imagine over time, we'll continue to work on evidence and education of these payers to drive the iDose procedure closer and closer to first-line therapy, where we believe it ultimately should be along, over the next decade-plus.

    顯然,如果我們要推出產品的話,這對我們來說是可以的。但你可以想像,隨著時間的推移,我們將繼續致力於證據和對這些付款人的教育,以推動 iDose 程序越來越接近一線治療,我們相信在未來十多年裡它最終應該達到這一水平。

  • Alex Thurman - Chief Financial Officer, Senior Vice President

    Alex Thurman - Chief Financial Officer, Senior Vice President

  • And then, based on the margin -- it's a great question. I'm glad you asked it because we were really pleased to see the margins come in at 83% a quarter. That represented really modest accretion, both on a year-over-year and a quarter-over-quarter basis. It also continues to be in this 82% to 84% range that we've been guiding to all year.

    然後,根據利潤率——這是一個很好的問題。我很高興你問這個問題,因為我們真的很高興看到利潤率達到每季 83%。無論是與去年同期相比,還是與上一季相比,這都代表著適度的成長。它也將繼續保持在我們全年預測的 82% 至 84% 範圍內。

  • And we've said for some time now that with iDose -- as you mentioned, that is a high-margin product. It was (inaudible) in the commercialization of iDose that we'd expect to see accretion in the gross margin over time. We hope that we're starting to see it now and that we'll continue to see modest accretion over the remaining quarters here.

    正如您所說,我們已經說過,iDose 是一款高利潤產品。在 iDose 商業化過程中(聽不清楚),我們預期毛利率會隨著時間的推移而成長。我們希望現在就能看到這一點,並且在接下來的幾個季度中我們將繼續看到適度的成長。

  • Thomas Burns - Chairman of the Board, Chief Executive Officer

    Thomas Burns - Chairman of the Board, Chief Executive Officer

  • Got it. Thank you.

    知道了。謝謝。

  • Operator

    Operator

  • Anthony Petrone, Mizuho Group.

    瑞穗集團的安東尼·佩特羅內。

  • Anthony Petrone - Analyst

    Anthony Petrone - Analyst

  • Thanks. I'll stick to two on iDose here.

    謝謝。我在這裡將堅持使用 iDose 上的兩個。

  • One, maybe, just when you think about the cadence that we're seeing now, how much is from early adopters here that have been with the iDose now maybe for a few quarters -- them increasing utilization versus new physician ads?

    首先,也許,當你思考我們現在看到的節奏時,有多少是來自已經使用 iDose 幾個季度的早期採用者——他們增加了利用率而不是新的醫生廣告?

  • And then, maybe just an update on managed care coverage for iDose. It sounds like based on some channel checks, you're starting to see a little bit of movement there. No official formulary coverage but there is some claims being processed. So anything you can share on the managed care firm for iDose would be helpful. Thanks.

    然後,也許只是對 iDose 的管理式醫療保險進行更新。聽起來根據一些管道檢查,你開始看到那裡有一點點動靜。沒有官方處方集覆蓋,但有一些索賠正在處理中。因此,您分享的任何有關 iDose 管理式醫療公司的資訊都會很有幫助。謝謝。

  • Joseph Gilliam - President, Chief Operating Officer

    Joseph Gilliam - President, Chief Operating Officer

  • Yeah. Anthony, first, there's always a lag effect -- as I mentioned earlier -- around position, awareness, adoption, and then, ultimately the procedure volume associated with that.

    是的。安東尼,首先,正如我之前提到的,總是存在滯後效應,涉及定位、意識、採用,以及最終與之相關的程序量。

  • These folks, as you know, have backlog in terms of procedures and when they get scheduled. And so what we're seeing is a mix of expanding, I'll call it, new physicians and the early dabbling, if you will, before they fully adopt, combined with increasing utilization of those early adopters.

    如您所知,這些人在程序和安排方面都有積壓工作。因此,我們看到的是不斷擴大的混合體,我稱之為新醫生和早期涉足(如果你願意的話),在他們完全採用之前,結合那些早期採用者的利用率不斷提高。

  • And, really, tying into the second part of your question, what we're starting to see in its earliest phases is for those earliest adopters who are now really going closer and closer to full scale, they're starting to expand into that broader patient population of commercially covered lives, as well as Medicare Advantage lots.

    實際上,聯繫到你問題的第二部分,我們開始看到的是,在其早期階段,那些最早的採用者現在實際上越來越接近全面採用,他們開始擴展到更廣泛的商業保險患者群體以及醫療保險優勢地段。

  • There's obviously a process with that. It's different than dealing with Medicare, as you know. And so the way we really continue to handle this is methodical [call] then maybe walk and ultimately, hopefully, jog and run as we make our way through the coming quarters and years, on an account-by-account basis.

    這顯然有一個過程。正如您所知,這與處理醫療保險不同。因此,我們真正繼續處理這個問題的方式是有條不紊的[呼叫],然後也許是步行,最終,希望是慢跑和奔跑,因為我們將在未來幾個季度和幾年內逐一處理每個帳戶。

  • You really have to make sure that even when you've got proper policies in place, the account, the practice are doing benefits verification, contracting, prior authorizations, claim processing, and all the things associated with proper managed care, lives -- that they're doing it in the right way.

    你確實必須確保,即使你已經制定了適當的政策,帳戶、實踐也在進行福利驗證、簽約、事先授權、索賠處理以及與適當的管理醫療、生活相關的所有事情——他們都在以正確的方式進行。

  • You want to ensure that success. So we're moving intentionally in a very methodical manner to make sure that they have a positive outcome, payer by payer and situation by situation, as they continue to grow.

    您要確保成功。因此,我們有意以非常有條理的方式採取行動,以確保他們在不斷發展的過程中,對每個付款人和每種情況都取得積極的結果。

  • Over time, we obviously expect this to be a significant portion of our business, especially the commercially covered lives. But we want to make sure that we set them up for success out of the gate here.

    隨著時間的推移,我們顯然預計這將成為我們業務的重要組成部分,尤其是商業壽險業務。但我們希望確保我們能為他們取得成功做好準備。

  • Anthony Petrone - Analyst

    Anthony Petrone - Analyst

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Danielle Antalffy, UBS.

    瑞銀的丹妮爾·安塔爾菲 (Danielle Antalffy)。

  • Danielle Antalffy - Analyst

    Danielle Antalffy - Analyst

  • Hey. Good afternoon, guys. Thanks so much for taking the question. Congrats on a strong quarter here.

    嘿。大家下午好。非常感謝您回答這個問題。恭喜本季業績強勁。

  • Just a question on where you're seeing physicians adopt iDose. Could you maybe talk a little bit about how they're balancing iDose versus iStent? What the decision pathway is to go with iDose versus iStent?

    我只想問一下您在哪裡看到醫生採用 iDose。您能否談談他們如何平衡 iDose 和 iStent?選擇 iDose 還是 iStent 的決策路徑是什麼?

  • Just because it could serve as a snapshot of five years from now, how these two different product lines are coexisting. Thanks so much.

    只是因為它可以作為五年後的快照,展示這兩條不同的產品線如何共存。非常感謝。

  • Joseph Gilliam - President, Chief Operating Officer

    Joseph Gilliam - President, Chief Operating Officer

  • Yeah. Thanks, Danielle. Obviously, it's still early days. And so you have to focus in more on those physicians who are adopting and are at the phase that Anthony's prior question -- are earlier adopters who are now moving into a part of their everyday, practice paradigm in managing patients with glaucoma.

    是的。謝謝,丹妮爾。顯然,現在還為時過早。因此,你必須更專注於那些正在採用並處於安東尼先前提出的問題階段的醫生——他們是早期採用者,現在正將其融入日常實踐模式中,用於管理青光眼患者。

  • I think what you're starting to see for those folks who are in that is that iDose becomes their foundational therapy. That's where they go, first and foremost. That shouldn't be a surprise, given how wide open that label is and its ability to treat patients up and down the disease spectrum.

    我認為對於那些處於這種狀態的人來說,你會開始看到 iDose 成為他們的基礎療法。那是他們首先要去的地方。這並不奇怪,因為該標籤的開放程度很高,並且能夠治療各種疾病譜的患者。

  • And they, then, turn increasingly to the iStent or iStent infinite, whether that be standalone or in combination, at times with iDose, to manage those patients who are progressing. They may have failed on a few more therapies along the way and they want to make sure that they really take every chance to arrest the progression of that disease and, hopefully, avoid the progression towards a more invasive a procedure, like a tube (inaudible) or other alternatives.

    然後,他們越來越多地轉向使用 iStent 或 iStent infinite,無論是單獨使用還是聯合使用,有時與 iDose 一起使用,來治療那些病情正在好轉的患者。他們可能在治療過程中嘗試過幾種療法但都失敗了,他們希望確保真正抓住每一個機會來阻止疾病的進展,並希望避免疾病發展到更具侵入性的手術,如插管(聽不清楚)或其他替代方案。

  • Operator

    Operator

  • That concludes our question-and-answer session.

    我們的問答環節到此結束。

  • I will now turn the call back over to the company for closing remarks.

    現在我將把電話轉回給公司,請他們發表結束語。

  • Thomas Burns - Chairman of the Board, Chief Executive Officer

    Thomas Burns - Chairman of the Board, Chief Executive Officer

  • Okay. Thank you all for your time and attention today.

    好的。感謝大家今天的時間和關注。

  • Again, we thank you for your continued interest and support of Glaukos. Goodbye.

    再次感謝您對 Glaukos 的持續關注和支持。再見。

  • Operator

    Operator

  • Ladies and gentlemen, this concludes today's call. Thank you all for joining. You may now disconnect.

    女士們、先生們,今天的電話會議到此結束。感謝大家的加入。您現在可以斷開連線。