使用警語:中文譯文來源為 AI 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Welcome to Glaukos Corporation's first quarter 2026 financial results conference call. Copies of the company's press release and quarterly summary document, both issued after the market close today, are available at www.glaukos.com.
歡迎參加 Glaukos Corporation 2026 年第一季財務業績電話會議。公司於今日收盤後發布的新聞稿與季度摘要文件副本,可於 www.glaukos.com 取得。
(Operator Instructions) This call is being recorded.
(接線員指示)本通話將被錄音。
And an archived replay will be available online in the Investor Relations section at www.glaukos.com. I will now turn the call over to Chris Lewis, Vice President of Investor Relations and Corporate Affairs.
並且,線上存檔重播將可於 www.glaukos.com 的投資人關係(Investor Relations)專區取得。現在我將把電話交給投資人關係與企業事務副總裁 Chris Lewis。
Christopher Lewis - Vice President of Investor Relations and Corporate Affairs
Christopher Lewis - Vice President of Investor Relations and Corporate Affairs
Thank you, and good afternoon. Joining me today are Glaukos Chairman and CEO, Tom Burns; President and COO, Joe Gilliam; and CFO, Alex Thurman.
謝謝,各位下午好。今天與我一同出席的有 Glaukos 董事長兼執行長 Tom Burns;總裁兼營運長 Joe Gilliam;以及財務長 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 be read by investors before the regularly scheduled quarterly conference call. (Event Instructions)
與先前季度相同,公司已在其投資人關係網站「財務與申報(Financials and Filings)」之「季度業績(Quarterly Results)」區塊中發布一份名為《季度摘要(Quarterly summary)》的文件。此文件旨在讓投資人在例行季度電話會議前先行閱讀。(活動指示)
Please note that all statements other than statements of historical factors 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, putting foreign currency fluctuations on our business and operations.
請注意,除歷史事實陳述外,本通話中所有涉及我們預期、相信或預估未來將會或可能發生之活動、事件或發展的陳述,均屬前瞻性陳述。這些陳述包括關於我們的計畫、目標、策略與前景之說明,內容涉及(但不限於)我們的銷售、產品、研發管線技術與臨床試驗、美國及國際商業化、市場開發工作、產品核准、現有及未來產品的療效、競爭市場地位、法規策略與產品給付(reimbursement)、財務狀況與營運成果,以及一般總體經濟情勢的預期影響,並將外匯波動對我們業務與營運的影響納入考量。
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.
這些陳述係基於目前對影響我們之未來事件的預期,並受限於與我們營運及商業環境相關的風險、不確定性與各項因素;上述事項多難以預測,且其中許多超出我們的控制範圍。因此,實際結果可能與前瞻性陳述所明示或暗示者存在重大差異。
Please review today's press release and our recent SEC filings for more information about these risk factors. You'll find these documents and. In the Investor Relations section of our website at www.glaukos.com.
請查閱今日新聞稿及我們近期向 SEC 提交的文件,以取得關於這些風險因素的更多資訊。您可在我們網站 www.glaukos.com 的投資人關係專區找到這些文件。
Finally, please note that during today's call, we will also discuss certain non-GAAP financial measures, including results on an adjusted basis. We believe these financial measures can facilitate a more complete analysis and greater transparency into Glaukos' ongoing results of operations, particularly when comparing underlying results from period to period.
最後,請注意在今日通話中,我們也將討論若干非 GAAP 財務衡量指標,包括以調整後(adjusted)基礎呈現的結果。我們相信,這些財務衡量指標可促進對 Glaukos 持續營運成果更完整的分析,並提升透明度,特別是在跨期間比較基本面結果時。
Please refer to the tables and earnings press release available on the Investor Relations section of our website for a reconciliation of these measures to their most directly comparable GAAP financial measure. With that, I will turn the call over to Glaukos Chairman and CEO, Tom Burns.
關於這些衡量指標與最直接可比較之 GAAP 財務衡量指標的調節(reconciliation),請參閱我們網站投資人關係專區所提供的表格與財報新聞稿。接下來,我將把電話交給 Glaukos 董事長兼執行長 Tom Burns。
Thomas Burns - Chairman of the Board, Chief Executive Officer
Thomas Burns - Chairman of the Board, Chief Executive Officer
Okay, thank you, Chris. Good afternoon and thank you all for joining us. Today, Glaukos reported record first quarter consolidated net sales of $150.6 million, up 41% on a reported basis and 39% on a constant currency basis versus the year-ago quarter.
好的,謝謝你,Chris。各位下午好,感謝大家加入我們。今天,Glaukos 公布 2026 年第一季合併淨銷售額創新高,達 1.506 億美元;以報告基礎計年增 41%,以固定匯率(constant currency)基礎計年增 39%,相較去年同期。
As a result of our first quarter outperformance, we are raising our full-year 2026 net sales guidance to $620 million to $635 million, compared to $600 million to $620 million previously.
由於第一季表現優於預期,我們將 2026 全年淨銷售額指引上調至 6.20 億至 6.35 億美元,先前為 6.00 億至 6.20 億美元。
Our first-quarter results reflect strong execution across our global commercial and development priorities, highlighting the commitment of our teams, the strength of our differentiating technology platforms, and our continued progression as an increasingly diversified leader in ophthalmology.
我們第一季的成果反映出在全球商業化與研發優先事項上的強勁執行力,突顯團隊的投入、我們具差異化的技術平台之實力,以及我們作為眼科領域日益多元化領導者的持續進展。
Looking ahead, we believe we are well-positioned to sustain this momentum driven by two transformational growth drivers including the continued advancement of the interventional glaucoma treatment paradigm with iDose TR and the launch of Epioxa, establishing a new standard in interventional keratoconus and rare diseases.
展望未來,我們相信在兩項具變革性的成長動能帶動下,我們已具備延續此一動能的良好條件:其一是透過 iDose TR 持續推進介入式青光眼治療典範;其二是推出 Epioxa,為介入式圓錐角膜(keratoconus)與罕見疾病建立新的標準。
Together, these compelling and durable market opportunities reinforce our confidence in delivering a best-in-class growth profile well into the next decade, as we continue to invest in and advance a robust industry-leading pipeline. While remaining disciplined in capital allocation, focusing on ROI-driven investments to support our near-term objectives of continued operating leverage and cash flow break-even.
這些具吸引力且可長期延續的市場機會,強化了我們的信心:在持續投資並推進強健、業界領先的研發管線之際,我們可在未來十年持續交付同級最佳的成長輪廓。同時,我們將維持資本配置紀律,聚焦以投資報酬率(ROI)為導向的投資,以支持我們短期目標:持續提升營運槓桿並達成現金流損益兩平。
Now, let's discuss our first-quarter results in more detail. Within our US-Glaucoma franchise, we delivered record first-quarter net sales of $93.5 million on strong year-over-year growth of 58%. Driven by growing contributions from iDose TR, which generated sales of approximately $54 million in the first quarter.
接下來更詳細說明第一季業績。在美國青光眼事業方面,我們第一季淨銷售額創新高,達 9,350 萬美元,年增 58%。主要由 iDose TR 貢獻成長所帶動,iDose TR 第一季銷售額約 5,400 萬美元。
iDose TR continues to deliver strong clinical outcomes that meaningfully improve patients' lives, driving strong physician interest and adoption. From an execution standpoint, we remain focused on our key initiatives, including expanding our base of trained surgeons and active accounts, increasing utilization, bonding market access, scaling targeted commercial investments, and expanding body of clinical evidence.
iDose TR 持續帶來強勁的臨床結果,能顯著改善病患生活,進而推動醫師高度興趣與採用。就執行面而言,我們仍聚焦於關鍵措施,包括擴大受訓外科醫師與活躍客戶據點的基礎、提升使用率、強化市場准入(market access)、擴大具針對性的商業投資規模,以及擴充臨床證據基礎。
On the last point, iDose TR is supported by a robust and growing body of clinical evidence demonstrating strong efficacy, safety, and durability of effect. This now includes 22 peer-reviewed publications, complemented by a broad portfolio of active Phase 4 studies across diverse, real-world clinical settings, further reinforcing its consistent performance in real-world practice.
就最後一點而言,iDose TR 具備強健且持續擴增的臨床證據,顯示其療效、安全性與效果持久性。這目前包括 22 篇同儕審查(peer-reviewed)出版物,並由多項在不同真實世界臨床情境中進行的第 4 期研究所補強,進一步印證其在實務應用中的一致表現。
Importantly, iDose TR is serving as the foundation for a broader shift towards earlier interventional glaucoma care. Our efforts to educate surgeons and key opinion leaders globally are gaining traction and helping to drive a steady evolution in the standard of care.
重要的是,iDose TR 正成為推動更早期介入式青光眼照護轉變的基礎。我們在全球教育外科醫師與關鍵意見領袖(KOL)的努力正逐步取得成效,並有助於推動照護標準的穩健演進。
This momentum was evident at recent major industry meetings, including AGS and ASCRS, where engagement and enthusiasm around interventional glaucoma and our novel therapies were notably strong and growing.
這股動能在近期主要產業會議上亦相當明顯,包括 AGS 與 ASCRS;會中對介入式青光眼以及我們創新療法的參與度與熱情顯著強勁且持續升溫。
To support these efforts, we continue to invest in our commercial organization and infrastructure to expand disease awareness and education, while enabling our customers to effectively adopt and operationalize interventional care into their clinical practice.
為支持上述工作,我們持續投資於商業組織與基礎建設,以提升疾病認知與教育,同時協助客戶能在其臨床實務中有效採用並落地執行介入式照護。
Moving on, our international glaucoma franchise delivered record net sales of $35.8 million and year-over-year growth of 23% on a reported basis and 16% on a constant currency basis. The strong growth was once again broad-based as we continue to scale our international infrastructure and execute our plans to drive mix forward as a standard of care in each region and market -- major markets in the world.
接著,我們的國際青光眼事業淨銷售額亦創新高,達 3,580 萬美元;以報告基礎計年增 23%,以固定匯率基礎計年增 16%。強勁成長再次呈現廣泛性;我們持續擴大國際基礎建設,並執行計畫,在各地區與市場推動產品組合朝向成為照護標準(standard of care)發展——涵蓋全球主要市場。
As previously discussed, we continue to expect new competitive product trialing headwinds in some of our major international markets as we progress through 2026, partially offset by growing contributions from iStent Infinite following its EU MDR certification and associated European commercial launch late last year. We also expect the currency tailwinds to abate going forward based on the current rate environment.
如先前所述,隨著我們在 2026 年持續推進,我們仍預期在部分主要國際市場將面臨新競品試用(trialing)所帶來的逆風;此影響將部分被 iStent Infinite 在去年底取得 EU MDR 認證並於歐洲展開商業上市後所帶來的日益增加貢獻所抵銷。我們也預期,基於目前利率/匯率環境,未來匯率順風(currency tailwinds)將逐步減弱。
And finally, our Corneal Health franchise delivered net sales of $21.3 million on year-over-year growth of 15%, including Fetrexan and very early Epioxa net sales of $17.7 million. At the end of the first quarter, we are delighted to announce commercial availability of Epioxa, our novel groundbreaking advancement in corneal cross-linking for the treatment of cons a rare cytidine disease that is currently far too often underdiagnosed, undiagnosed and untreated.
最後,我們的角膜健康事業淨銷售額為 2,130 萬美元,年增 15%,其中包括 Fetrexan 以及非常初期的 Epioxa 淨銷售額合計 1,770 萬美元。於第一季末,我們很高興宣布 Epioxa 已可商業供應;Epioxa 是我們在角膜交聯(corneal cross-linking)領域的全新突破性進展,用於治療圓錐角膜——這是一種罕見疾病,目前仍經常被低估診斷、未被診斷與未被治療。
We believe Epioxa represents a transformative innovation in care comes care offering an incision-free alternative to traditional corneal cross-linking procedures, and it does not require the removal of the corneal epithelium, the outer most layer or the front of the eye. This novel oxygen-enriched topical therapeutic bioactivated by UV light is designed to reduce the pain associated with removal of the epithelium, streamline the procedure and minimize recovery, all while delivering clinically meaningful outcomes and exceptional value to patients, providers in the health care system.
我們相信 Epioxa 代表照護上的變革性創新,提供相較傳統角膜交聯手術的無切口替代方案,且不需要移除角膜上皮(corneal epithelium)——也就是眼睛最外層/前表層。此一富氧的創新外用治療,經由紫外光(UV light)生物活化(bioactivated),其設計目的在於降低移除上皮所伴隨的疼痛、簡化流程並縮短復原,同時提供具臨床意義的結果,並為病患、醫療提供者與整體醫療體系帶來卓越價值。
Response we received from surgeons in the broader ophthalmic community since FDA approval and the more recent initial commercial launch activities has been very encouraging. As we've discussed, with the launch of Epioxa, we have redefined our go-to-market approach to better address the site threat disease and truly expand patient care and access.
自 FDA 核准以及近期初步商業上市活動以來,我們從更廣泛的眼科社群外科醫師所收到的回饋非常令人鼓舞。如同我們先前所討論,隨著 Epioxa 的推出,我們已重新定義上市策略(go-to-market approach),以更妥善因應此一「視力威脅性疾病」(sight-threatening disease),並真正擴大病患照護與可近性。
Importantly, with this launch, we are substantially increasing our investments in patient awareness, education and access, while addressing the long-standing challenges of underdiagnosis and under treatment that have affected this rare disease community. As with all pharmaceutical launches, initial patient access will be gated by typical payer adoption headwinds in hurdles, but we've been encouraged by the progress we've made in the short order through the early days of our launch.
重要的是,隨著此次上市,我們正大幅增加在病患認知、教育與可近性方面的投資,同時解決長期以來影響此罕見疾病社群的低診斷率與治療不足等挑戰。與所有藥品上市相同,初期病患可近性將受到典型的支付方採用(payer adoption)逆風與門檻所限制,但我們對於在上市初期短時間內所取得的進展感到鼓舞。
First, I'm proud to report that we have successfully established and continue to selectively expand a broad-reaching site of care network. Our acquired O2N systems are already actively deployed across locations serving roughly 65% of the US population with the pipeline progressing through various approval processes that we expect will expand our treatment center reach to approximately 95%. Looking ahead, we will continue evolving this network to bring treatment access closer to patients as reimbursement and drug acquisition pathways become further established and streamlined.
首先,我很自豪地報告,我們已成功建立並持續選擇性擴展一個覆蓋廣泛的照護據點(site of care)網絡。我們所併購的 O2N 系統已在各地點積極部署,服務範圍約涵蓋美國 65% 的人口;同時,我們的管線正推進各項審批流程,預期將把我們治療中心的覆蓋範圍擴大至約 95%。展望未來,隨著給付(reimbursement)與藥品採購(drug acquisition)途徑進一步建立並簡化,我們將持續演進此網絡,讓治療可近性更貼近患者。
Next, we continue to make considerable progress with payers to secure access pathways or policy coverage for Epioxa with several plants having already updated or are in the process of updating their policies to include this novel therapy. These efforts are translating into expanded access with pathways now established or more than 100 million covered commercial lives in the United States, including with four of the five largest payers reflecting encouraging initial receptivity of Epioxa's clinical value.
其次,我們持續與支付方(payers)取得顯著進展,以確保 Epioxa 的可近性途徑或政策給付覆蓋;目前已有數家計畫(plans)完成更新或正在更新其政策,以納入這項創新療法。這些努力正轉化為更廣泛的可近性:目前在美國,已建立的途徑所覆蓋的商業保險人數已超過 1 億,包括五大支付方中的四家,顯示對 Epioxa 臨床價值的初步接受度令人鼓舞。
While we expect the pace of policy adoption to build over time, we remain focused on driving broader commercial -- or sorry, broader coverage across both commercial payers and Medicaid programs to support more streamlined access pathways over time.
雖然我們預期政策採納的速度將隨時間逐步加快,但我們仍專注於推動更廣泛的商業——抱歉,是在商業支付方與 Medicaid 計畫之間的更廣泛覆蓋,以便隨時間推進更順暢的可近性途徑。
Earlier this month, we achieved another important market access milestone as CMS has signed a product-specific J-code for Epioxa, consistent with our expectations and in response to our application. The new code J2789 is scheduled to take effect on July 1, 2026, and we believe it will help streamline the reporting and reimbursement process for Epioxa among US payers over time. Until then, we anticipate Epioxa will be commercially available under a new technology miscellaneous J-code and anticipate measured adoption over this initial period until the permanent J-code is in place and solidified operationally by providers in our specialty pharmacy.
本月稍早,我們達成另一項重要的市場准入里程碑:CMS 已依我們的申請、且符合我們的預期,為 Epioxa 核發產品專屬的 J-code。新代碼 J2789 預計於 2026 年 7 月 1 日生效;我們相信,隨時間推進,這將有助於在美國支付方之間簡化 Epioxa 的申報與給付流程。在此之前,我們預期 Epioxa 將以新的技術雜項(new technology miscellaneous)J-code 進行商業供應,並預期在此初期期間採納將較為循序漸進,直到永久 J-code 正式到位,並由我們專科藥局(specialty pharmacy)的醫療提供者在作業面上完成落地與固化。
Beyond market access, we're proud to lead the way once again on forging a new path for interventional care to come by advancing a targeted marketing and DTC initiatives to drive awareness, education and earlier detection, supported by greater optometric engagement and strengthened advocacy partnerships. Finally, we launched a co-pay assistance program for eligible patients and are operationalizing a specialty pharmacy partner network in support of Epioxa patients.
除市場准入外,我們也很自豪再次領先,透過推進精準的行銷與 DTC(直接面向消費者)倡議,為介入式照護(interventional care)開創新路徑,以提升認知、教育與更早期的檢出;同時,這些工作也由更高的驗光(optometric)參與度與更強化的倡議夥伴關係所支持。最後,我們為符合資格的患者推出自付額(co-pay)協助計畫,並正在建置一個專科藥局合作夥伴網絡,以支援 Epioxa 患者。
As you can see, we are very excited by the significant potential Epioxa offers to patients living with keratoconus. While Epioxa remains in the early stages of its launch, our teams are energized and executing with focus, and we're encouraged by the solid progress we're making against our core launch priorities.
如各位所見,我們對 Epioxa 為圓錐角膜(keratoconus)患者所帶來的重大潛力感到非常振奮。雖然 Epioxa 仍處於上市初期階段,我們的團隊士氣高昂、聚焦執行;我們也對在核心上市優先事項上所取得的扎實進展感到鼓舞。
Beyond Epioxa, we continue to advance a broad and differentiated clinical pipeline across our five novel therapeutic platforms encompassing 13 publicly disclosed programs and additional undisclosed assets supported by a robust portfolio of active clinical and Phase 4 studies. This includes ongoing pivotal trials for iDose TREX, iStent infinite and mild to moderate patients and the PreserFlo MicroShunt, an active Phase 2 trial for iLution Demodex blepharitis, ongoing development for our Link platform, including a planned market introduction of our KC screening device late this year and our promising earlier-stage rental assets. Overall, we remain on track with our clinical time lines and encouraged by the progress across our complete portfolio.
除 Epioxa 之外,我們也持續推進一個廣泛且具差異化的臨床研發管線,涵蓋五個創新治療平台,包含 13 個已公開揭露的專案,以及其他未公開資產;並由強健的在研臨床與第 4 期(Phase 4)研究組合所支持。其中包括 iDose TREX、iStent infinite 與輕至中度患者,以及 PreserFlo MicroShunt 的關鍵性試驗(pivotal trials)持續進行;iLution Demodex 眼瞼緣炎(blepharitis)的第 2 期(Phase 2)試驗正在進行;我們 Link 平台的開發亦持續推進,包括計畫於今年稍晚推出我們的 KC 篩檢裝置,以及我們具前景的更早期階段研發資產。整體而言,我們的臨床時程仍按計畫推進,並對整體產品組合的進展感到鼓舞。
In conclusion, at Glaukos, we're in the business of pioneering new marketplaces within ophthalmology for the benefits of patients. Our record first quarter performance highlights the strength of our strategy and execution as we continue evolving into an increasingly diversified atomic leader with multiple transformational growth drivers in iDose TR and Epioxa and advance our mission to transform vision therapies for the benefits of patients worldwide.
總結而言,在 Glaukos,我們致力於在眼科領域開創新的市場,以造福患者。我們第一季創紀錄的表現突顯了我們策略與執行力的強勁;我們持續演進為日益多元化的領導者,並擁有多項具變革性的成長驅動因素,包括 iDose TR 與 Epioxa,同時推進我們的使命:轉變視覺治療,造福全球患者。
So with that, I'll open the call for questions. Operator?
那麼,接下來我將開放提問。接線員?
Operator
Operator
(Operator Instructions)
(接線員指示)
Tom Stephan, Stifel.
Tom Stephan,Stifel。
Thomas Stephan - Analyst
Thomas Stephan - Analyst
Great. Thanks for the question. Nice quarter. First one on Epioxa, Tom or Joe, maybe if you can talk about early findings, one, on sort of how initial experiences in sort of the claims and prior of processes are going? And two, what demand in the market looks like sort of from an early utilization standpoint, maybe based on what you're seeing in the Epioxa patient portal?
很好。謝謝回答問題。這一季表現不錯。第一個問題關於 Epioxa,Tom 或 Joe,也許你們可以談談早期觀察:第一,初期在理賠(claims)與事前授權(prior authorization)流程方面的經驗進展如何?第二,從早期使用(utilization)的角度來看,市場需求大概是什麼樣子——也許可以根據你們在 Epioxa 病患入口網站(patient portal)所看到的情況來分享?
And then I'll have a quick follow-up.
然後我會再快速追問一題。
Joseph Gilliam - President, Chief Operating Officer
Joseph Gilliam - President, Chief Operating Officer
Sure. Thanks, Tom. It's Joe. I'll start off there. I think Tom gave you some of the higher-level stats, the progress we're making with the Epioxa launch, both in terms of the two fundamental, I think, foundational items, both our side of care network as well as the broader payer pathways.
當然。謝謝,Tom。我是 Joe。我先回答。我想 Tom 已提供一些較高層級的數據,說明我們在 Epioxa 上市推進上的進展,主要涵蓋兩個我認為最根本、最基礎的面向:我們的照護據點網絡,以及更廣泛的支付方途徑。
Underlying that, which I think you're asking a good question is the process of making your way through that. And clearly, it's hard to judge too much on that until we get into the post J-code period because at this point, you're dealing with the miscellaneous code. So all systems around that, you will are, by definition, slower than normal as you adjudicate on a claim-by-claim basis.
在此之下——我想你問得很好——是實際推進這些流程的過程。而且很明顯,在進入 J-code 生效後的期間之前,很難對此做太多判斷,因為目前仍在使用雜項代碼(miscellaneous code)。因此,圍繞該代碼的所有系統作業,按定義都會比正常情況更慢,因為需要逐筆理賠(claim-by-claim)進行審核裁定(adjudicate)。
But I will say that we've been very encouraged by those sites of care who come online, as Tom referenced. And the patient flow that's coming from that and into our portal in the hub, as you say, as a leading indicator of what it can mean for the clinical demand associated with an Epi-On therapy like Epioxa. So as we make our way through that, and we see those claims get adjudicated, which we've seen positive claims get through the process and also those procedures get done now. We're encouraged by, I'll call the is the leading indicator in terms of that funnel as it develops.
但我想說的是,我們對那些如 Tom 所提及、已上線的照護據點感到非常鼓舞。由此帶來的患者流量,並進入我們的入口網站與中樞(hub),正如你所說,可作為一個領先指標(leading indicator),反映像 Epioxa 這類 Epi-On 療法所對應的臨床需求可能意味著什麼。因此,隨著我們持續推進、並看到這些理賠被裁定——我們已看到有正向的理賠成功通過流程,且相關處置也已開始執行——我們對這個漏斗(funnel)在發展過程中的領先指標感到鼓舞。
Thomas Stephan - Analyst
Thomas Stephan - Analyst
Got it. That's great. And then Follow-up just on iDose, really solid in the quarter. Joe, maybe to stick with you, can you just talk about drivers of the strength? And it'd be great if you could maybe also discuss kind of Noridian and Novitas versus the remaining MAX and what you're seeing in kind of each of those two pools, if you will?
了解。很棒。接著追問 iDose,本季表現非常強勁。Joe,也許繼續請你談談:這股強勁表現的驅動因素是什麼?另外,如果你也能談談 Noridian 與 Novitas 相對於其餘 MAX 的情況,以及你在這兩個「池子」中各自看到的狀況,那就太好了。
Joseph Gilliam - President, Chief Operating Officer
Joseph Gilliam - President, Chief Operating Officer
Yes, absolutely. I think the most encouraging thing about the results of the first quarter was it was very broad-based in terms of what drove that performance. It was continued expansion within the more established, I'll call it, MAX. And you referenced Noridian, Novitas subset by First Coast in that as well. I'll come back to that.
好的,當然可以。我認為第一季結果最令人鼓舞之處在於,驅動該表現的因素非常廣泛且多元。這包括在較成熟的——我稱之為——MAX 區域內的持續擴張;你也提到其中的 Noridian、Novitas 子集,以及 First Coast。我稍後再回到這點。
But now you start to see NGS, in particular, turning on, the early signs of Palmetto turning on as well as we've more recently achieved a professional fee formally in that region. And I think also is encouraging was a real increase certainly the funnel into our hub associated with commercial and Medicare Advantage patient flow. So I think it was broad and consistent with what you would hope to expect in the context of our core initiatives.
但現在你開始看到 NGS 尤其開始啟動(turning on),也看到 Palmetto 早期啟動的跡象;此外,我們近期也在該區域正式取得專業費用(professional fee)。我認為同樣令人鼓舞的是,與商業保險與 Medicare Advantage 患者流量相關、進入我們中樞(hub)的漏斗明顯增加。因此我認為這是廣泛且一致的,符合你對我們核心倡議所期望看到的結果。
To put a finer point, I think on your question around Noridian, Novitas, typically, I talked about that in the context of Noridian plus Novitas First Coast is some of the earlier adopting MAX. And in the first quarter, that was down to about 7% of the overall region volumes, if you will, from 78% in the fourth quarter. And again, that's really because as they continue to grow, you might expect the adoption curves to be picking up even faster in areas like NGS and Palmetto.
更精確地回應你關於 Noridian、Novitas 的問題:我通常會把 Noridian 加上 Novitas First Coast 放在一起,視為較早採納的 MAX 區域。而在第一季,這部分占整體區域量(region volumes)的比重已降至約 7%,相較於第四季的 78%。同樣地,這主要是因為當它們持續成長時,你會預期在像 NGS 與 Palmetto 這些地區,採納曲線(adoption curves)會以更快速度攀升。
Operator
Operator
Adam Maeder, Piper Sandler.
Adam Maeder,Piper Sandler。
Adam Maeder - Senior Research Analyst
Adam Maeder - Senior Research Analyst
Congrats on a great start to the year. The first one for me, I wanted to ask a modeling question. So nice Q1 top line , you raised the full year outlook by more than the Q1 outperformance. You've given a lot of great modeling color in the past. So Joe, maybe for you or Alex, can you just kind of pull apart the updated guidance with iDose contribution versus the [iStent] business versus corneal health and as we think about Q2 in particular and as it relates to Epioxa, I would appreciate if you could give us a little bit of modeling help.
恭喜今年有個很好的開局。我第一個問題想問建模(modeling)相關。第一季營收表現不錯,你們把全年展望上調的幅度甚至超過第一季的超預期表現。你們過去提供過很多很好的建模細節。所以 Joe,也許你或 Alex 可以把更新後的指引拆解一下:iDose 的貢獻、[iStent] 業務的貢獻、以及角膜健康(corneal health)的貢獻;另外,特別是我們在看第二季時,及其與 Epioxa 的關聯,也希望你們能提供一些建模上的協助。
And then I have a follow-up.
然後我還有一個追問。
Joseph Gilliam - President, Chief Operating Officer
Joseph Gilliam - President, Chief Operating Officer
Sure, Adam. I'll dive in, and I'll give at least some introduced comments on that front. And if folks have additional questions, we could add in a little bit deeper. But as you said, it was a great start to the year With really each of our franchises exceeding expectations, and we made considerable progress across all those fronts, including within interventional glaucoma and iDose in particular.
好的,Adam。我先來回答,先提供一些初步的說明。如果大家還有其他問題,我們也可以再更深入一些。但如你所說,今年開局非常好,我們各個事業線(franchises)都超出預期,且我們在各方面都取得了顯著進展,包括在介入式青光眼(interventional glaucoma)領域,尤其是 iDose。
And as a result, we were able to raise our guidance up to the $620 million to $635 million range. And as you think about that in your models by franchise on a handful of perspectives, first by franchise.
因此,我們得以將我們的指引上調至6.20億至6.35億美元的區間。當你在模型中從幾個角度、按各事業線(franchise)來思考時,首先從事業線的角度來看。
On the international glaucoma side, I'd say really the dynamics here are somewhat unchanged. Obviously, we expect, as we move forward here, some of the currency benefits that you heard Tom call out in the prepared remarks will weight in. And so we do expect that going forward, we'll see sort of high single-digit growth for the remainder of this year. Now when you put all that together, that's going to translate into low double-digit growth for the full year. But the remaining quarters, we would expect single-digit growth in that franchise.
在國際青光眼方面,我會說這裡的動態基本上沒有太大改變。顯然,隨著我們往前推進,你們在事先準備的發言中聽到Tom提到的一些匯率利多將會逐步反映出來。因此我們預期,今年剩餘期間將呈現約高個位數成長。把這些合在一起,全年將轉化為低雙位數成長。但就剩餘季度而言,我們預期該事業線將是個位數成長。
On the Corneal Health side, Obviously, I think everybody knows there's a fair number of moving parts there. It was a strong first quarter. But we do continue to anticipate volatility associated with both the TREX and Epioxa transition, but also the temporary permanent J-code transition over the course of, call it, Q2 and Q3. And so when you put all together with the performance and what we're sort of seeing we now expect kind of high single-digit growth for this franchise for the entire year. with some puts and takes in the individual quarters as we get there.
在角膜健康(Corneal Health)方面,顯然我想大家都知道那裡有相當多的變動因素。第一季表現強勁。但我們仍預期,無論是TREX與Epioxa的轉換,或是所謂在Q2與Q3期間的臨時/永久J-code轉換,都會帶來波動。因此把表現以及我們目前看到的情況綜合起來,我們現在預期該事業線全年大致為高個位數成長;在各個季度之間,隨著進展會有一些此消彼長。
And as you've heard me say in the past, we certainly expect to be exiting the fourth quarter with a pretty strong performance curve as we start to pull through Epioxa in a more meaningful way.
而且如同我過去所說,我們確實預期在第四季結束時,隨著Epioxa更有意義地開始放量,我們將以相當強勁的表現曲線收官。
On the US glaucoma side, again, another strong start to the year, we would adjust our views there probably to be more in the, I'll call it, low 30s type growth for the full year, and that's really driven by still an ongoing view that going forward we should expect kind of flattish non-high dose sales going forward until we've really been proven otherwise and continued sequential progress as we've been seeing with the iDose launch. So you put all that together, and I think as you said, we not only do we raise our overall guidance, but we raised the reach of our underlying franchises and the drivers.
在美國青光眼方面,同樣是今年一個強勁的開局;我們可能會把全年成長的看法調整到大約「30%出頭」的區間。這主要是因為我們仍然認為,除非後續被證明不是如此,否則未來非高劑量(non-high dose)銷售大致會維持平坦;同時,iDose上市以來我們看到的連續季度改善仍會持續。把這些合在一起,我想如你所說,我們不僅上調了整體指引,也提高了各個底層事業線及其驅動因素的預期。
I will add just because you asked about, I think, for Q2 in particular, given there's a lot going on here, and it's all good, but I want to make sure we've got it as do as possible. That for the US glaucoma franchise, as I alluded to earlier, in Q2, I think we expect sort of flat non-iDose and that continued sequential iDose expansion.
我再補充一點,因為你問到特別是Q2;考量這裡有很多事情在進行,而且都是好事,但我想確保我們盡可能把它說清楚。就美國青光眼事業線而言,如我先前提到的,在Q2我們預期非iDose大致持平,而iDose則持續按季擴張。
In interventional glaucoma, we'd expect the high single digits as we talked about that benefit wanes. And the corneal side, I think as we said on the last call, we would expect in the second quarter to see a bit of a dip there on a year-over-year basis as we transition from Photrexa to Epi-On.
在介入性青光眼(interventional glaucoma)方面,隨著我們談到的那項利多逐漸消退,我們預期成長在高個位數。至於角膜端,如同我們在上次電話會議所說,我們預期第二季在年對年基礎上會出現一些下滑,因為我們正從Photrexa轉換到Epi-On。
Adam Maeder - Senior Research Analyst
Adam Maeder - Senior Research Analyst
Really appreciate all the color, Joe. And if I could just sneak in a follow-up. I wanted to ask about iDose and or reaching a point now where you have critical mass from a reimbursement standpoint. So Tom or Joe, can you just maybe talk about some of the new initiatives that you're going to start to put in place here. I think you've talked about growing the commercial team potentially looking at direct-to-consumer as we get into the latter part of the year.
Joe,真的很感謝你提供的所有細節。如果我可以再追問一下:我想問iDose,或者說我們是否已經到了一個在給付(reimbursement)面具備臨界規模(critical mass)的階段。Tom或Joe,你們能否談談接下來會開始推動的一些新措施?我想你們提過可能擴編商業團隊,並且在今年下半年考慮做面向消費者的推廣(direct-to-consumer)。
We just love some incremental color for kind of the next chapter.
我們很希望能再多聽一些關於下一章的補充說明。
Joseph Gilliam - President, Chief Operating Officer
Joseph Gilliam - President, Chief Operating Officer
Yes, you're exactly right, Adam. We've always talked about you didn't want to put some of these things into place until you start to have a more solid foundation from a reimbursement standpoint. Certainly, what you're hearing in the context of our first quarter results and our guidance is increasing confidence in that foundation, both in terms of the five of the seven MAX that are now stable by professional fees and the team is driving incremental confidence both on the reimbursement side as well as, obviously, the clinical and commercial side. But also now increasingly as we move forward here on the broader commercial Medicare Advantage.
是的,Adam,你說得完全正確。我們一直都在談,在給付面還沒有更穩固的基礎之前,不希望把其中一些事情提前推進。當然,從第一季結果與我們的指引脈絡來看,你們聽到的是我們對這個基礎的信心正在提升:一方面是七個MAX中已有五個在專業費用(professional fees)上趨於穩定;另一方面,團隊也在給付端、以及臨床與商業端持續推動,帶來更高的信心。此外,隨著我們往前推進,在更廣泛的商業Medicare Advantage方面也正在逐步改善。
So I think as we've talked about in the past, as we move forward here, it's about driving increased awareness for iDose and interventional glaucoma and teams that help drive that broader environment of both education of patients as well as the process to get them treated by an interventional procedure like iDose. So we have been making significant investments for some time now in more of our reimbursement and business teams that surround the traditional sales force to really try to make sure that we can maximize both patient access and that broader awareness initiatives.
因此我想,如同我們過去談過的,接下來的重點是提升對iDose與介入性青光眼的認知,並建立能推動更廣泛環境的團隊:既包括病患教育,也包括讓病患能透過像iDose這樣的介入性處置完成治療的流程。為此,我們一段時間以來已在傳統銷售隊伍之外,對給付與商務相關團隊進行重大投資,目的就是要盡可能最大化病患可近性(access)以及更廣泛的認知提升計畫。
So I think you should expect to see more of that certainly as we get into the second half of this year and as we get closer to exiting the year and heading into next based upon this trajectory where we're going to feel, I think, a lot more confidence in starting to make some of those more offensive investments.
所以我認為你們應該會看到更多這類動作,尤其是在今年下半年、以及接近年底並邁向明年時;基於目前這條成長軌跡,我們會更有信心開始進行一些更具進攻性的投資。
Operator
Operator
Larry Biegelsen, Wells Fargo.
Wells Fargo的Larry Biegelsen。
Larry Biegelsen - Analyst
Larry Biegelsen - Analyst
Congratulations to you. Maybe one on iDose and one on Epioxa. Joe, if you could talk about how you've engaged with the MAX since the CAC meeting last year. Any updated thoughts on the likelihood of an LCD this year and the timing of those two RCPs you're running? And I had one follow-up.
恭喜你們。我有兩個問題:一個關於iDose,一個關於Epioxa。Joe,你能否談談自去年CAC會議以來,你們如何與MAX互動?對於今年出現LCD的可能性,以及你們正在進行的兩項RCP的時程,有沒有更新的看法?我還有一個追問。
Joseph Gilliam - President, Chief Operating Officer
Joseph Gilliam - President, Chief Operating Officer
Yes, I'll start off at the beginning, and Tom can comment on the broader studies that we're doing associated with iDose here in a minute. So as we think about the engagement with the MAX, I'm not sure we have a particularly different strategy here. We've always engaged in an education process to make sure they understand our technologies, how they utilize the labels and indications for use around them. And we continue to do that. We continue to try to diagnose where we've got ongoing I'll call it, less streamline reimbursement in areas like CGS and WPS, and we continue to have momentum in some of those conversations.
好的,我先從前半段開始,Tom稍後可以補充我們在iDose相關的更廣泛研究。就與MAX的互動而言,我不確定我們在策略上有特別不同。我們一直以來都透過教育流程,確保他們理解我們的技術,以及我們如何依照標籤(label)與適應症(indications for use)來使用。我們會持續這麼做。我們也持續嘗試釐清在CGS與WPS等區域仍存在的、我稱之為較不順暢的給付流程,並且在這些對話中持續取得進展。
So hopefully, we're marching forward those two MAX in a productive way,, they can drive professional fee establishment similar to the other five larger MACs that have come before them.
因此,希望我們能以具建設性的方式推動這兩個MAX向前,讓他們能像先前其他五個較大的MAC一樣,建立專業費用(professional fee)。
As it relates to the post-CAC conversation LCD conversation, really no changes on this front since our last call, Larry, and we've talked about it. At this point, we've not seen any signs of an LCD and we continue to believe it would be premature at this stage of the clinical adoption curve. Having said that, obviously, by nature of these things can be unpredictable and okay. So it certainly remains possible even if we believe it's less probable disappoint.
至於CAC之後關於LCD的討論,Larry,這部分自上次電話會議以來沒有任何改變,我們也談過。目前我們尚未看到任何LCD的跡象,而且我們仍認為在臨床採用曲線的這個階段,推出LCD仍屬過早。話雖如此,這類事情本質上可能難以預測,所以當然仍有可能發生,即使我們認為其機率較低。
Thomas Burns - Chairman of the Board, Chief Executive Officer
Thomas Burns - Chairman of the Board, Chief Executive Officer
And I think to address your question on Phase 4 studies, Larry, that we've contemplated actually been enrolling for some time, once we receive NDA approval, we have done two major Phase 2 studies. The first would be iDose plus cataract versus cataract surgery alone to be able to demonstrate the incremental value of using iDose in combination with cataract surgery.
Larry,關於你問的第4期研究,我們其實早已在規劃並且在一段時間前就開始收案;在取得NDA核准後,我們已做了兩項主要的第2期研究。第一項是比較「iDose合併白內障手術」對比「單純白內障手術」,以證明在白內障手術中合併使用iDose所帶來的增量價值。
And that study is actually fully enrolled, and we'll be following those patients over the course of this coming year. And we'll be looking to publish the data at regular intervals. And I think that will be a very powerful supplement to the data that we currently have on hand, again, another 22 peer-reviewed clinical trials.
該研究目前已完成收案,我們將在接下來一年持續追蹤這些病患,並會在固定的時間點尋求發表數據。我認為這將會是對我們目前手上資料非常有力的補充;再次強調,我們目前已有另外22項同儕審查的臨床試驗。
And then I think we were largely present in also doing a study looking at iDose versus iDose plus infinite because I want to show the incremental value of these two different mechanisms of action to be able to lower intraocular pressure to supremely low target pressures, which will by all evidence to be able to force the progression of glaucoma or progression in glaucoma.
另外,我想我們也大幅投入進行一項研究,比較iDose對比iDose加上infinite,因為我想展示這兩種不同作用機轉在降低眼內壓方面的增量價值,並能把眼內壓降到極低的目標壓力;依據所有證據,這將有助於抑制青光眼的惡化或青光眼進展。
I think with both of these in hand, I think it will be timely in case in any event in the future, we're challenged by any magazine using either combination modalities or procedural pharmaceuticals plus MIGS or using iDose in combination with cataract surgery.
我認為有了這兩項研究在手,未來若在任何情境下,我們面臨外界對於採用組合治療模式、或程序性藥物加上MIGS、或是在白內障手術中合併使用iDose等做法的質疑,這些資料都會在適當時點提供有力支撐。
Joseph Gilliam - President, Chief Operating Officer
Joseph Gilliam - President, Chief Operating Officer
One other thing I'll just add, Larry, I think even at a minimum on this these studies that Tom's are referencing as important as the broader payer community. So this is how you continue to expand that coverage irrespective of MAX and LCDs, et cetera, with the individual commercial players in Medicare Advantage plans to make sure that we're optimizing that access for our patients.
另外我再補充一點,Larry,我認為即使在最低限度上,這些 Tom 所提及、被視為重要的研究,對更廣泛的付款方社群同樣重要。因此,這就是你如何在不受 MAX 與 LCD 等因素影響的情況下,持續與 Medicare Advantage 計畫中的各個商業保險業者擴大給付覆蓋,確保我們能為病患最佳化取得治療的可近性。
Larry Biegelsen - Analyst
Larry Biegelsen - Analyst
And for my follow-up on Epioxa, Joe, I'm going to ask you kind of more of a big picture question. I think from our past conversations, you felt confident that Epioxa could return to peak Photrexa levels of roughly 18,000 to 19,000 eyes by the end of the decade. And if that's paid volume, that would be well north of $1 billion in revenue. So I guess, my question is you still -- how are you feeling about achieving that? And what is the ramp to that look like?
接著我想追問一下 Epioxa,Joe,我會問一個比較宏觀的問題。我想從我們過去的對話來看,你對 Epioxa 在本十年末能回到 Photrexa 的高峰水準、約 18,000 到 19,000 眼的量是有信心的。如果那是已給付的量,營收將遠超過 10 億美元。所以我想問的是,你現在對達成這個目標的感受如何?以及達到那個水準的爬坡曲線會是什麼樣子?
Joseph Gilliam - President, Chief Operating Officer
Joseph Gilliam - President, Chief Operating Officer
Yes, Larry, I mean, I think I'll stop short of obviously making the longer-term predictions formally and just say I think we have been on record saying we view this as a potential $1 billion-plus franchise the pace in which we get there, we'll continue to monitor as we get into the actual true commercialization, especially if we get towards the second half of this year. But I think part and parcel of that is I don't think we view it just in the context of where we've been with Photrexa patient volumes.
是的,Larry,我的意思是,我當然不會正式去做更長期的預測,但我可以說,我們一直公開表示,我們把這視為一個有潛力超過 10 億美元的產品/業務版圖。至於我們達到那裡的速度,隨著我們進入真正的商業化階段,特別是如果我們走到今年下半年,我們會持續觀察。不過其中一個重點是,我不認為我們只會用過去 Photrexa 的病患量來看待這件事。
We're making the investments we're making, which are enormous moving forward to drive increased awareness and detection and ultimately action and access in the hopes that we can treat, quite frankly, far more than that. We believe that there are more than the 18,000 to 19,000 eyes at any given time that should be getting diagnosed and treated.
我們正在進行的投資非常龐大,目的是在未來推動更高的認知、篩檢與偵測,最終促成行動與可近性,希望能治療的量坦白說遠遠超過那個數字。我們相信,在任何一個時間點,應該被診斷並接受治療的眼數不只 18,000 到 19,000 眼。
And so from our standpoint, a lot of the DTC and the things that you've heard Tom reference, we'll be putting those investments towards hopefully growing this overall market from a volume perspective over that period of time and getting more and more of these patients treated.
因此就我們的立場而言,許多 DTC(直接面向消費者)以及你聽到 Tom 提到的那些作法,我們會把投資投入在希望於那段期間從量的角度擴大整體市場,讓越來越多這些病患能接受治療。
Thomas Burns - Chairman of the Board, Chief Executive Officer
Thomas Burns - Chairman of the Board, Chief Executive Officer
And I would just add on that, if you think about what the possibilities are to build this marketplace over the planning period, and it's really important to be able to recognize what we have beyond this planning care, certainly at the tail end of the planning period, this would be the second-generation customized algorithms that we have in place for the treatment of keratoconus that can't help but the market expanding if we show demonstrable changes in K-MAX for these patients and have the possibility of actually increasing their best corrected visual acuity by virtue of customized algorithms that we're going to be able to dispense and use on these patients with keratoconus.
我也想補充,如果你思考在規劃期間內建立這個市場的可能性,能夠認知到我們在這個規劃期之外還擁有什麼是非常重要的。當然在規劃期尾端,我們將會有第二代、客製化的圓錐角膜治療演算法;如果我們能在這些病患的 K-MAX 上展現可證明的變化,並且透過我們將能提供並用於圓錐角膜病患的客製化演算法,實際提升其最佳矯正視力,那麼市場擴張幾乎是必然的。
So I'm very bullish not only on the near term of all the different mechanisms we're putting in place to build the marketplace, but our possibility of having a second wind moving into the 2030s, which will increase our presence in this rare disease.
所以我不僅對我們在短期內為建立市場而部署的各種機制非常樂觀,也對我們在 2030 年代可能迎來第二波成長的機會感到非常看好,這將提升我們在這個罕見疾病領域的能見度與存在感。
Operator
Operator
Ryan Zimmerman, BTIG.
Ryan Zimmerman,BTIG。
Ryan Zimmerman - Analyst
Ryan Zimmerman - Analyst
Congrats on strong start here. Just kind of dovetailing on some of the questions before. There's been obviously a lot of investor concern about these LCD risk. I know you just addressed it. But Tom, I guess my question is around the existing body of evidence.
恭喜你們在這裡有個強勁的開局。我想延續前面一些問題。投資人顯然對這些 LCD 風險有很多擔憂。我知道你們剛剛已經回應了。不過 Tom,我的問題是關於現有的證據基礎。
I'm wondering if you could kind of talk about it in contrast to the Phase 4 study. And remind us what percentage now that we have quite a track record with iDose, what percentage are you seeing today either in combination with cataract or with another MIG in terms of the iDose usage? And if some of the studies already bear out evidence of combinatorial usage of iDose with other products or procedures, do you think that is sufficient or the Phase 4 study is really necessary to kind of refute any concerns there?
我想請你談談它與第四期(Phase 4)研究相比的情況。另外也請你提醒我們,現在我們對 iDose 已經有相當的使用紀錄了,你們今天看到的 iDose 使用中,有多少比例是與白內障手術合併,或是與其他 MIG(微創青光眼手術)合併?如果一些研究已經顯示 iDose 與其他產品或處置合併使用的證據,你認為那是否已足夠,還是第四期研究真的有必要來反駁相關疑慮?
Thomas Burns - Chairman of the Board, Chief Executive Officer
Thomas Burns - Chairman of the Board, Chief Executive Officer
I'll let Joe start and I might add some color. Go ahead, Joe.
我先讓 Joe 開始回答,我可能再補充一些說明。Joe,你先。
Joseph Gilliam - President, Chief Operating Officer
Joseph Gilliam - President, Chief Operating Officer
Yes. I'll start on the -- in the context of the trends that we've seen. Certainly, I think they remain consistent, Ryan, with the past commentary. The relative percentage of the procedures done today where surgeons are treating glaucoma with iDose and at the same time, in conjunction with the cataract procedure, it's growing as expected, given obviously, Glaukos has already changed the standard of care for those patients.
好的。我先從我們看到的趨勢脈絡來談。當然,Ryan,我認為這些趨勢與我們過去的評論一致。就目前手術中,外科醫師使用 iDose 治療青光眼、同時與白內障手術合併進行的相對比例而言,它如預期般在成長,因為很明顯 Glaukos 已經改變了這些病患的照護標準。
But at the same time, our efforts remain focused on that interventional glaucoma opportunity, and we continue to see rapid growth in the number of stand-alone procedures.
但同時,我們的努力仍聚焦在介入式青光眼(interventional glaucoma)的機會上,而且我們持續看到單獨(stand-alone)手術數量快速成長。
So I would say that the majority of patients last year still saw a stand-alone iDose procedure, but the mix is certainly shifting towards in combination with cataract or in combination with another mix as you might expect, because these physicians are trying to obviously do everything they can to slow the progression of the sight-threatening disease.
所以我會說,去年多數病患仍是接受單獨的 iDose 手術,但如你所預期,組合結構確實正在往與白內障合併、或與其他手術合併的方向轉移,因為這些醫師顯然正盡其所能減緩這種威脅視力疾病的進展。
Thomas Burns - Chairman of the Board, Chief Executive Officer
Thomas Burns - Chairman of the Board, Chief Executive Officer
And I would just say, based on the question that you have, most of the Phase 4 studies we do and as Joe has mentioned, are really for the payers and for moving into commercial payers and Medicare Advantage. I think surgeons a priority already have the confidence that putting iDose in combination with cataract surgery is going to yield an incremental effect. I think that you will see that in any channel actually do. Likewise, the use of combination therapy of iDose plus an iStent infinite, surgeons will have high confidence that they're going to treat incremental effect. So the studies we're doing are less to be able to drive that portion of the market.
我再補充一下,針對你的問題,我們做的大多數第四期研究,如 Joe 所提到的,主要是為了付款方,以及推進到商業保險與 Medicare Advantage。我認為外科醫師本來就有信心:把 iDose 與白內障手術合併會帶來額外的效果。我想你在任何通路都會看到這點。類似地,iDose 加上 iStent infinite 的合併治療,外科醫師也會非常有信心能帶來增量效果。因此,我們進行的研究較不是為了推動那一部分市場。
They're more to validate surgeons already existing confidence in using these technologies together.
而是更多用來驗證外科醫師對於把這些技術一起使用所已具備的信心。
Ryan Zimmerman - Analyst
Ryan Zimmerman - Analyst
Understood. And then maybe a question for Joe and Alex even, which is just operating expense guidance and your thoughts on profitability. I mean it's almost getting to a point where despite your best efforts, you will become profitable in kind of the next year.
了解。接著可能是給 Joe 以及 Alex 的問題,關於營業費用指引與你們對獲利能力的看法。我的意思是,幾乎到了某個程度,即使你們再怎麼努力,你們在接下來一年左右也會開始獲利。
And I'm wondering kind of how you think about the ramp in sales -- or excuse me, the ramp in expenses needed for Epioxa commercialization and kind of what that does or doesn't do to your time lines or at least in our model, our time line to profitability?
我想問你們如何看待銷售爬坡——抱歉,是費用爬坡——也就是 Epioxa 商業化所需的費用提升,以及這對你們的時間表會造成什麼影響或不影響;或者至少在我們的模型裡,對獲利時間表的影響?
Alex Thurman - Chief Financial Officer, Senior Vice President
Alex Thurman - Chief Financial Officer, Senior Vice President
Ryan, it's Alex. I'll start, and I'll start with profitability. Again, just to reiterate what Tom had mentioned in his opening remarks, our near-term focus in managing the business do so on a cash flow breakeven and driving basically operating leverage within the P&L, which we're pleased to say we saw in the first quarter, and we're glad that, that execution is happening. But as we look ahead to your point, we certainly can see with the commercial launches of iDose that we definitely have a fairly clean line of sight towards that pathway of profitability over the next few years.
Ryan,我是 Alex。我先回答,先談獲利。再次重申 Tom 在開場致詞提到的,我們短期內在經營管理上的重點,是以現金流損益兩平為目標,並在損益表中推動營運槓桿;我們很高興第一季已經看到這點,也很高興執行正在發生。但展望未來,如你所說,隨著 iDose 的商業上市,我們確實對未來幾年走向獲利的路徑有相當清晰的能見度。
To your point, some of it will depend on the ramp of these commercial launches and the associated revenues that come with it. But as we continue to manage the business towards that cash flow breakeven, you'll see from an operating expense side that we continue to reinvest in the business and reinvest in these commercial launches. And we've talked about the fact that our operating expenses will grow this year, year-over-year. And we feel that way. And I'll just give you some commentary now that as we did overachieve in the first quarter, Tom and I and Joe have talked about adding additional fuel to fuselage and these commercial launches.
如你所說,其中一部分將取決於這些商業上市的爬坡速度以及隨之而來的營收。但當我們持續以現金流損益兩平來管理公司時,你會看到在營業費用端,我們會持續再投資於業務、再投資於這些商業上市。我們也談過,今年的營業費用會年增,我們仍然這麼認為。我也補充一些看法:由於第一季表現超出預期,Tom、我和 Joe 已討論要為這些商業上市再加一些燃料、加大推進力。
So you should see the operating expenses tick up slightly and modestly from what we talked about at the beginning of the year, but still in the high teens and still showing that operating leverage overall as we progress throughout the year.
因此你應該會看到營業費用相較我們年初所談略為、且溫和地上調,但仍會落在高十位數(high teens)的成長區間,並且隨著我們在今年持續推進,整體仍會展現營運槓桿。
Joseph Gilliam - President, Chief Operating Officer
Joseph Gilliam - President, Chief Operating Officer
I think, Ryan, the overall -- when you hear Tom and I talking about the incremental spending from DTC or otherwise, it's important to note that, a lot of that is by its very nature discretionary. So as we look forward, you're thinking about making those investments alongside the significant growth that we're achieving and hopefully with the hopes of a return on investment that makes that certainly worth the incremental spend associated with it.
Ryan,我認為整體而言——當你聽到 Tom 和我談到 DTC 或其他方面的增量支出時——重要的是要注意,其中很多支出本質上是可裁量的(discretionary)。因此展望未來,你會把這些投資與我們正在達成的顯著成長一起考量,並希望其投資報酬能讓相關的增量支出變得非常值得。
So we'll be in a process here where we're continuing to evaluate the effectivity of those efforts and what that return looks like before diving in with 2 feet, if you will, to go full spend on DTC related efforts. We've always been pretty disciplined in how we thought about those types of things.
因此,我們會在這裡持續評估這些努力的有效性,以及在真正「兩腳都踏進去」之前,先看清楚回報會是什麼樣子;也就是說,在全面加大與 DTC 相關投入之前。我們一向在思考這類事情時相當自律、相當有紀律。
Operator
Operator
Allen Gong, JPMorgan.
Allen Gong,摩根大通。
Allen Gong - Analyst
Allen Gong - Analyst
Thanks for the question. I wanted to start off with one actually on the core US glaucoma business. I think iDose clearly had a really strong quarter, but underlying years glaucoma also did quite a bit better than expected and grew at a healthy clip year-over-year. albeit also a bit of an easy comp, I believe.
謝謝這個問題。我想先從美國核心青光眼業務談起。我認為 iDose 顯然有非常強勁的一季,但非 iDose 的青光眼基礎業務也比預期好很多,且年增率維持健康的成長速度,雖然我相信也有一點比較基期較容易的因素。
So when I think about your forecast, your reiteration for flat for 2Q and the year, what are you seeing that kind of supports that outlook? Is it just conservatism? Or are there real challenges that you're seeing out in the market?
所以當我看你們的預測、你們重申第二季與全年持平的展望時,你們看到哪些因素支撐這樣的看法?這只是保守起見嗎?還是你們在市場上確實看到一些真正的挑戰?
Joseph Gilliam - President, Chief Operating Officer
Joseph Gilliam - President, Chief Operating Officer
Yes, Allen, thanks for the question. I mean you're right in the context that this was the second straight quarter where we've seen about the restoration of growth in that non iDose remainder or as you said, I think, core US glaucoma franchise. So I think we've certainly seen signs of stabilization of the underlying market there. And I think that our teams are doing a great job in -- on the performance side within that more now more stabilized market.
是的,Allen,謝謝你的問題。你的脈絡是對的,這是我們連續第二個季度看到非 iDose 的其餘部分——或者如你所說,我想是美國核心青光眼產品線——的成長恢復。所以我認為我們確實看到那個基礎市場出現穩定的跡象。而且我認為在這個如今更穩定的市場中,我們團隊在表現面做得非常好。
As we go forward, I think we're just not ready yet to make that call. that, that is, I'll call it, the new normal that we're operating in. It's been an encouraging two quarters. But as we look forward here, I think it's still safer for us and for investor expectations to be in that sort of more flat year-over-year basis until we've proven otherwise on a sustained basis.
往前看,我認為我們還沒有準備好做出那個判斷——也就是說,這就是我們所處的「新常態」。這兩個季度令人鼓舞,但展望未來,我們認為在尚未以可持續的方式證明之前,對我們以及投資人預期而言,維持年對年大致持平的基調會更安全。
There are some things in there. Obviously, I think we benefited a little bit in the quarter from some supply chain disruptions on the competition front. It's hard to measure that. I don't think it's material, but that should subside as we move forward here. So I think we just want to play a couple more innings here of this on that side before we rerate our view on guidance there.
其中也有一些因素。很明顯地,我認為本季我們在某種程度上受惠於競品端的一些供應鏈中斷。這很難衡量;我不認為影響重大,但隨著我們往前走,這種情況應該會消退。所以我認為在我們重新評估並上調那邊的指引觀點之前,我們想再多觀察幾個回合。
Allen Gong - Analyst
Allen Gong - Analyst
Got it. And then, I guess, a follow-up, moving on to Corneal Health. You talked about how you've reached coverage of 65% of the US population with line of sight to reaching 95%, I believe, the number was. How quickly do you think you can get to that 95%?
了解。那接著我想追問一下,轉到角膜健康(Corneal Health)。你提到你們已經覆蓋美國人口的 65%,並且我記得你說有望達到 95%。你認為多快可以到 95%?
Is that a target you think you can reach by the end of the year? Or is it going to maybe slow down a little bit now that you grab some of the low-hanging fruit?
這是你們認為在年底前就能達成的目標嗎?還是說在拿到一些「低垂的果實」之後,接下來速度可能會放慢一些?
Joseph Gilliam - President, Chief Operating Officer
Joseph Gilliam - President, Chief Operating Officer
Yes. Thanks, Allen. In some ways, it's actually been accelerating, as you might imagine, once you announced commercial availability and the transition plan becomes more real. What we've seen is more of an acceleration than a deceleration on that front.
是的,謝謝,Allen。某種程度上,實際上它正在加速,正如你可以想像的,一旦你宣布商業供應可得性,且轉換計畫變得更具體、更真實。我們看到的是加速而不是減速。
Having said that, you also know that hospital systems and even certain other customers have longer cycles for bringing on new technologies and new drugs to the pharmacy network and the like. And so I think we'll continue to make substantial progress here every month and certainly hope that we're getting there or close to that target in terms of realized side of care network by the end of the year.
話雖如此,你也知道醫院體系以及某些其他客戶,將新技術與新藥納入藥局網路等流程的週期較長。因此我認為我們每個月都會持續取得實質進展,並且當然希望在年底前,在已實現的照護據點網路(site of care network)方面能達到或接近那個目標。
Operator
Operator
David Roman, Goldman Sachs.
David Roman,高盛。
David Roman - Analyst
David Roman - Analyst
Maybe I could just start on Epioxa here. Could you maybe talk to us a little bit about some of the specific market development efforts that you have underway. And maybe you can kind of break them into whether it's physician and practice education, patient assistance programs and then engagement and education with payers?
我想先從 Epioxa 開始。你們能否跟我們談談目前正在進行的一些具體市場開發工作?也許你可以把它們拆分成:醫師與診所端教育、病患協助計畫,以及與付款方的互動與教育?
Joseph Gilliam - President, Chief Operating Officer
Joseph Gilliam - President, Chief Operating Officer
Yes. Sure, David. It's Joe. On the Epioxa side, I think about it kind of as follows. So I won't repeat what Tom has already said, and we comment on.
好的,當然可以,David。我是 Joe。就 Epioxa 這邊,我大概是這樣看。我就不重複 Tom 已經說過、以及我們已經評論過的內容。
There's a foundational element that's first and foremost, when you're kind of going through the stage of a launch. And that is that you get the Sidecar network established, affected trained and everything ready there. The second layer of that is that you're engaging with the payers in a way to establish access pathways and then ultimately from there, further streamlining and optimizing those.
首先有一個基礎層面,是你在推進上市階段時最優先的事情:也就是把 Sidecar 網路建立起來,完成訓練並把所有事情準備就緒。第二層則是以建立可及性路徑的方式與付款方互動,接著在此基礎上進一步簡化並優化這些路徑。
And then as you go alongside of that, you start to dial up, I'll call it, the more physician-related and even patient-related marketing efforts. But you don't want to do that too soon in that life cycle until really the overall ecosystem is ready.
然後在這些工作並行推進的同時,你會開始加大——我稱之為——更偏向醫師端、甚至病患端的行銷投入。但在整體生態系尚未就緒之前,你不希望在生命週期太早就做這件事。
So a lot of where we're at right now is around the last part of what you said, which is making sure that as we're having success with the site of care network and on the patient side, that the machinery in the middle is working as efficiently as possible to make sure that we're working things through the hub and through our specialty pharmacy, and we're providing that visibility to our customers and to our patients, that our co-pay assistance programs are working as they're intended. And all the stuff that probably is a little less interesting to investors but are -- is critically important to the ultimate success here as we move forward.
所以我們目前很多工作重點是在你提到的最後一部分:確保當我們在照護據點網路與病患端取得進展時,中間的機制能以最高效率運作——確保我們能透過 hub 與我們的專科藥局把流程跑順,並把可視性提供給我們的客戶與病患;確保我們的自付額(co-pay)補助計畫如預期運作。這些事情對投資人來說可能沒那麼有趣,但對於我們接下來的最終成功至關重要。
And as I mentioned earlier in the call, we're really encouraged by that initial burst, if you will, of patients that are going in there. And now we have to get through that process of trying to get them on therapy which can be a lengthy one when you're dealing with a miscellaneous J-code. And so navigating that is paramount for us before we get obviously the formal J-code in the second half.
而且如我先前在電話會議中提到的,我們對於最初那一波——如果你願意這麼說——進入系統的病患數量感到非常鼓舞。現在我們必須走完讓他們真正開始治療的流程;當你面對的是雜項 J-code 時,這個流程可能會很長。因此,在我們於下半年取得正式 J-code 之前,如何把這件事導航好對我們而言是首要之務。
David Roman - Analyst
David Roman - Analyst
Very helpful. Maybe just a follow-up here on iDose. And I know you talked a little bit about this, but could you just talk to some extent whether there was any contribution here from having the reimplantation approval that came early in the first quarter? To what extent that may be giving physicians increased confidence implanting iDose? And how we should think longer term about the interplay between having the readministration label as an iDose TREX?
非常有幫助。接著想就 iDose 追問一下。我知道你們稍早有提到一些,但你們能否談談第一季初期較早取得再植入(reimplantation)核准,是否對本季有任何貢獻?在多大程度上,這可能讓醫師在植入 iDose 時更有信心?以及長期來看,我們應該如何理解「可再給藥(readministration)」標示與 iDose TREX 之間的相互影響?
Joseph Gilliam - President, Chief Operating Officer
Joseph Gilliam - President, Chief Operating Officer
Yes. Well, I can confirm that we've now seen numerous successful readministration procedures as some of those earliest patients are getting out several years. It's not the predominant procedure being done. It's still a small fraction, but we've seen multiple surgeons do readministration and do so successfully. We've seen payer policy updates occur and a lot of, I'll call it, general progress on that front.
是的。我可以確認,我們現在已經看到多起成功的再給藥手術,因為一些最早期的病患已經走過好幾年。這不是目前最主要的手術類型,仍然只占很小一部分,但我們看到多位外科醫師進行再給藥且都成功。我們也看到付款方政策更新,以及我稱之為在這方面的整體進展。
So I think we're encouraged, and this is sort of in line with what we always expected that has the benefits of the initial procedure start to wane that both the patient and the provider are going to want to continue that therapy given the clear benefits to the patients. So we're seeing that start to happen.
所以我認為我們感到鼓舞,這也符合我們一向的預期:當初次手術的效益開始減弱時,病患與醫療提供者都會希望延續這項治療,因為它對病患有明確的好處。因此我們正看到這件事開始發生。
And I think as we look out over the long run, certainly, readministration becomes a much more material part of that overall mix. Every month and every quarter that we move forward here, it should be more and more relevant to what we're looking at. But out of the gate, we're encouraged by what we're seeing.
而且我認為從長期來看,再給藥當然會成為整體組合中更具實質性的部分。隨著我們每個月、每一季往前推進,它對我們所觀察的內容應該會越來越相關。但在一開始,我們對目前看到的情況感到鼓舞。
Operator
Operator
Richard Newitter, Truist Securities.
Richard Newitter,Truist Securities。
Richard Newitter - Analyst
Richard Newitter - Analyst
Congrats on the quarter. Just wondering if you could give us any kind of color on what's happened to the provider base as this transition to Epioxa is taking place? I'm not looking for you to necessarily give us a specific number of doctors or your installed base per se.
恭喜這一季的表現。想請問在轉換到 Epioxa 的過程中,醫療提供者(provider)基礎發生了什麼變化?我不是要你們一定提供具體的醫師數量或你們的裝機基礎(installed base)之類的數字。
But do you guys envision just a big concentration over the next few quarters in a small number of providers' hands to getting all of this refined and figured out from a consistency on the payment standpoint? Or is this potentially going to be broader and not as concentrated than maybe what I'm suggesting, as we think through this?
但你們是否預期接下來幾季會高度集中在少數幾家提供者手上,先把付款一致性等問題都打磨清楚、摸索到位?還是說,從我們的推演來看,這可能會更廣泛、沒有我所暗示的那麼集中?
Just trying to get a sense for is it really a dramatically fewer number of doctors? Or is it going to be potentially broader than that?
我只是想了解一下:會不會真的變成醫師數量大幅減少?還是可能比那更廣?
Joseph Gilliam - President, Chief Operating Officer
Joseph Gilliam - President, Chief Operating Officer
I appreciate the question, Richard. I think -- well, first, I think on the definition of how you do concentrate it. I mean I think relative to our iDose user base, for example, inherently in keratoconus even with Photrexa, you had a relatively concentrated group of centers and sites that were doing the procedures.
謝謝你的問題,Richard。我認為——嗯,首先我想先談你所說「集中」的定義。我是說,相對於例如我們的 iDose 使用者基礎,在圓錐角膜(keratoconus)領域,即使是使用 Photrexa,你本來就有一群相對集中的中心與據點在執行這些手術。
Now I won't surprise you and I think that with Epioxa, it was our intent, obviously, to make sure that your initial site of care network is as concentrated as you can reasonably be to try to make sure you're close enough to the vast majority of the US population.
現在我不會讓你感到意外,我認為就 Epioxa 而言,我們的意圖很明確,就是要確保你最初的照護據點(site of care)網絡在合理範圍內盡可能集中,以便確保你與美國絕大多數人口的距離足夠近。
So inherently, our wave one, if you will, efforts have been very targeted around the country in that context. But I'll tell you, in some respects, our wave one efforts have gone maybe a little too well. And that's caused us to have to accelerate some investments to meet the needs of that customer base and their patients that are coming out of that. So there will always be earlier adopters than mid adopters in a launch, and we'll see that here, obviously, part of Epioxa. But I'm not particularly concerned about any significant concentration issues in any one or two or even 10 customers.
因此,從本質上來說,我們的第一波(wave one)推進工作在這個脈絡下,確實是在全國範圍內非常有針對性地展開。但我也要說,某些方面,我們第一波的推進可能進展得有點太順利了。這也迫使我們必須加速一些投資,以滿足那批客戶及其患者所帶來的需求。所以在產品上市時,永遠都會有較早採用者與中期採用者,而在 Epioxa 的推進上我們也會看到這一點。不過,我並不特別擔心在任何一兩個、甚至 10 個客戶身上出現顯著的集中度問題。
I think it's going to be measured much more in hundreds of customers ultimately than it is in single digits.
我認為最終衡量的單位更可能是數百個客戶,而不是個位數。
Richard Newitter - Analyst
Richard Newitter - Analyst
Yes. That's helpful. And then is there any one area where the spend that you're stepping up from a position of offense, clearly is directed now that you've had some early learning experiences? In other words, where are the frictions most notable either to a doctor not wanting to do this, not wanting to buy Epioxa and move forward? Or is it more on the pull side from the patients and the demand awareness increase standpoint?
是的,這很有幫助。接著,從你們在「進攻」立場上加碼的支出來看,在有了一些早期學習經驗之後,是否有某一個特定領域是你們現在明確把資源導向的?換句話說,摩擦點最明顯的是在哪裡——是醫師端不想做、不想購買 Epioxa 並往前推進?還是更多來自患者端的拉動(pull),例如需求端的認知提升與需求覺察增加?
Joseph Gilliam - President, Chief Operating Officer
Joseph Gilliam - President, Chief Operating Officer
Yes. I would say it's actually maybe a bit more -- and so if you think about this, whatever -- there's always going to be conversation in education, both the sales force and the broader teams to make sure people understand what we're doing, why we're doing it, how we're doing it as it relates to the Epioxa launch. And certainly, in the future, as we've talked about, there'll be a lot more of that spend oriented towards, I'll call it, more growth and DTC education related.
是的。我會說其實可能更偏向——如果你這樣想,無論如何——在教育層面總是會有很多溝通,包含銷售團隊以及更廣泛的團隊,確保大家理解我們在做什麼、為什麼做、以及在 Epioxa 上市推進上我們如何去做。當然,未來如我們所談到的,會有更多支出會導向我稱之為更偏成長與 DTC(直接面向消費者)教育相關的部分。
Right now, in this moment, where a lot of that spend is going, it should surprise you, is much more in that initial lift, confidence and process associated with claims prosecution and adjudication. It's about making sure that customers understand how it works that they're successfully seeking prior authorizations that were supporting that process where appropriate to plan and then ultimately getting those patients access to that care.
但就當下這個時間點而言,很多支出流向的地方(這應該不會讓你意外)更偏向於最初的啟動、信心建立,以及與理賠申報(claims prosecution)與核賠(adjudication)相關的流程。重點在於確保客戶了解整個運作方式、他們能成功申請事前授權(prior authorization),在適當情況下我們也支援與保險計畫(plan)相關的流程,並最終讓患者能取得該項照護的可近性。
So a lot of it is much more in the machinery, I'll call it within the market access world than it is necessarily in marketing or even sales from that standpoint.
所以其中很大一部分更像是在市場准入(market access)領域內的「機械結構/運作機制」,而不一定是行銷,甚至也不完全是銷售層面的投入。
Operator
Operator
Mason Carrico, Stephens Incorporated.
Mason Carrico,Stephens Incorporated。
Unidentified Participant
Unidentified Participant
This is Harrison on for Mason. Would you be willing to provide some color on the utilization of the various cohorts of surgeons trained on iDose? Is there portion of the surgeon base today that you would say has matured at this point with more stable utilization? Or are you still seeing pretty robust utilization growth across these older cohorts of surgeons, too?
我是代替 Mason 的 Harrison。你們是否願意就已接受 iDose 訓練的不同外科醫師群組(cohorts)的使用情況提供一些補充說明?目前是否有一部分外科醫師群體,你們會說其使用量已經成熟、趨於穩定?還是你們在這些較早期的群組中也仍看到相當強勁的使用量成長?
Joseph Gilliam - President, Chief Operating Officer
Joseph Gilliam - President, Chief Operating Officer
Yes, Harrison, I'm not sure I would say that we're reaching stabilization, if you will, in any one cohort. I mean if you think about it, even for some of the earliest adopters, there's still ongoing enhancements to how they think about interventional glaucoma, the amount of time they're spending on that versus other areas of their practice, let alone, as we talked about coming into this year and again on this call, the movement from, I'll call it, the more traditional fee-for-service patient population into the commercial and Medicare Advantage world.
是的,Harrison,我不確定我會說我們在任何一個群組上已經達到所謂的穩定化。我的意思是,如果你想想看,即便對一些最早採用者而言,他們對介入性青光眼(interventional glaucoma)的思考方式仍在持續精進,他們在這一領域投入的時間相對於其執業中的其他領域也在調整;更不用說,正如我們在今年初以及這通電話中提到的,患者結構正從我稱之為較傳統的按服務計費(fee-for-service)人群,轉向商業保險與 Medicare Advantage 的世界。
So I think we continue to see growth across both our more mature customer base as well as certainly with the addition of new surgeons and new practices throughout the country. So we're still pretty early in that overall evolution curve, if you will, of this launch.
因此,我認為我們在較成熟的客戶基礎上仍持續看到成長,同時也因為全國各地新增外科醫師與新診所的加入而帶來成長。所以就這次上市推進而言,我們仍處於整體演進曲線相當早期的階段。
Unidentified Participant
Unidentified Participant
Got it. Yes, that's helpful. And then second question here. Could you update us on the progress you've made this year from a commercial payer standpoint on iDose? I think the middle of last year, you called out more than 50% of Medicare Advantage and commercial policies had a positive policy in place.
了解,是的,這很有幫助。第二個問題:你們能否更新一下今年在 iDose 的商業保險支付方(commercial payer)方面所取得的進展?我記得去年年中你們提到,超過 50% 的 Medicare Advantage 與商業保險保單已經有正向的政策(positive policy)到位。
Where does that percentage stand today?
那麼目前這個比例是多少?
Joseph Gilliam - President, Chief Operating Officer
Joseph Gilliam - President, Chief Operating Officer
Yes. So I'm not sure it's changed a significant amount in this past quarter, but just to put a line of sand sitting here today with iDose, we have about 99% patients have an access pathway in the commercial and Medicare Advantage arena. To the point you made in your question, about 50% of those patients are in plans where there's a specific policy attached to it and the remainder, where there's silence, we're certainly seeing successful pull-through on that.
是的。所以我不確定在過去這一季是否有顯著變化,但就今天此刻 iDose 的情況來畫一條界線:在商業保險與 Medicare Advantage 領域,大約 99% 的患者都有一條可行的准入途徑(access pathway)。如你問題中所提到的,約 50% 的患者所在的保險計畫有明確對應的特定政策(specific policy),其餘部分則屬於「未明確表態(silence)」的情況,而我們也確實看到在這種情況下仍能成功拉通(pull-through)。
I'll also add that in these, I call the early days of the real efforts here, we're seeing a very, very high success rate in the context of the prior authorizations that are submitted for these patients across that landscape, which is what you'd expect given the statistics I just got done citing around the broader patient access pathways.
我也補充一下,在我稱之為這些真正投入推進的早期階段,我們看到在整個版圖中,針對這些患者所提交的事前授權(prior authorization)成功率非常、非常高;考量到我剛剛引用的整體患者准入途徑統計,這也符合你的預期。
Operator
Operator
David Saxon, Needham.
David Saxon,Needham。
David Saxon - Equity Analyst
David Saxon - Equity Analyst
Congrats on the quarter. I wanted to start on the specialty pharmacy channel or with RCM. So I mean, I imagine the docs doing Epioxa were previously doing buy and bill with Photrexa. So maybe you were seeing you. So what's the feedback been from them in terms of process and whether there's any friction in that kind of change of workflow?
恭喜本季表現。我想先從專科藥局(specialty pharmacy)通路或 RCM(營收循環管理)談起。我是說,我想做 Epioxa 的醫師之前應該是用 Photrexa 的 buy and bill 模式。所以也許你們之前看到你們——那麼他們對於流程的回饋如何?以及在這種工作流程改變上是否有任何摩擦?
Joseph Gilliam - President, Chief Operating Officer
Joseph Gilliam - President, Chief Operating Officer
Yes, David. So I think that historically speaking, with the mix, there were certainly those customers who prefer to buy and bill Photrexa and those customers who acquired it through the pharmacy channel, in this case, in our case, Orsini, and that continues going forward. I think it will surprise you that certainly amongst our non hospital-based customers the vast majority, certainly out of the gate are choosing to access the drug via our specialty pharmacy. And so that does mean some of them are doing this for the first time with our channel.
是的,David。就歷史而言,依照組合來看,確實有一些客戶偏好以 buy and bill 的方式取得 Photrexa,也有一些客戶透過藥局通路取得——在我們的案例中是 Orsini——而這種情況未來也會持續。我想可能會讓你意外的是,特別是在我們非醫院型(non hospital-based)的客戶中,絕大多數在一開始就選擇透過我們的專科藥局取得藥品。因此,這也意味著其中一些客戶是第一次透過我們的通路採用這種方式。
I think it's a little too early to comment specifically around that dynamic because, again, as what I said earlier, when you're in the miscellaneous code environment, even with a perfectly streamlined, I'll call it, hub and specialty pharmacy process, the process to getting that access for the patient is much more elongated. And we've only had the drug on the market now for a month.
我認為現在要對這個動態做出具體評論還稍早,因為——如我先前所說——當你處於雜項代碼(miscellaneous code)的環境時,即便 hub 與專科藥局流程完全順暢,我所稱之為取得患者准入的流程仍會更為拉長。而且我們的藥品上市到現在也才一個月。
So from that standpoint, I think we're still in the early days of adjudicating those claims and getting access to the drug via the SP channel. But more to come on that. And we're certainly encouraged with the work that Orsini's been doing to make sure that they're in network with these various plans.
因此,就這個角度來看,我們仍處於透過 SP(專科藥局)通路核賠這些理賠並讓患者取得藥品的早期階段。後續會有更多資訊。但我們對 Orsini 為確保其納入各類保險計畫網絡(in network)所做的工作感到相當鼓舞。
And I think ultimately, that's going to accrue to the benefit of our customers who choose that channel.
我認為最終這將使選擇該通路的客戶受益。
David Saxon - Equity Analyst
David Saxon - Equity Analyst
Great. And then maybe one for Alex, just on the group gross margin. So maybe remind us what your expectations are for the year. And then as we go through iDose and Epioxa looking to next year, kind of how we should think about gross margin potential?
很好。接著可能問 Alex 一題,關於整體毛利率(group gross margin)。能否提醒我們你們對今年的預期?以及隨著 iDose 與 Epioxa 的推進、展望明年,我們應該如何看待毛利率的潛力?
Alex Thurman - Chief Financial Officer, Senior Vice President
Alex Thurman - Chief Financial Officer, Senior Vice President
You bet. Thanks, David. I mean -- we saw 84% margin in the first quarter, which was up 120 basis points from last year. So we -- that was please to see that. In the last call, we -- I gave a range for the year of an expectation of 84% to 86%.
當然可以。謝謝你,David。我的意思是——我們第一季看到 84% 的毛利率,較去年提升了 120 個基點。所以我們——很高興看到這點。在上一通電話中,我——我給了今年的預期區間為 84% 到 86%。
And sitting here today, we still continue to feel comfortable with that guidance range for the year with expected accretion over the course of the year as products like Epioxa become a greater share of the mix.
而就今天此刻而言,我們仍然對這個年度指引區間感到有信心,並預期隨著像 Epioxa 這類產品在組合中占比提高,全年過程中毛利率會逐步增厚(accretion)。
And then to your point, looking forward in 2027, we'll comment more further when we get closer, but you would expect accretion as these products continue to ramp.
再回到你提到的展望,放眼 2027 年,我們會在更接近時再做更多評論,但你可以預期,隨著這些產品持續放量爬坡,毛利率會有所增厚。
Operator
Operator
Michael Sarcone, Jefferies.
Michael Sarcone,Jefferies。
Michael Sarcone - Analyst
Michael Sarcone - Analyst
Thanks for squeezing me in here. So just a follow-up on the Epioxa specialty pharmacy question. I mean, when you think about buy and bill, understanding that specialty pharmacy is coming first, can you talk about options that you may have or are evaluating to enable or efficiently enable buy and bill for Epioxa down the road?
謝謝讓我插個問題。針對 Epioxa 專科藥局的問題再追問一下。我的意思是,當你們考慮 buy and bill,並理解目前會先以專科藥局為主,你們能否談談未來有哪些選項是你們可能採用或正在評估的,以便在之後為 Epioxa 啟用或更有效率地啟用 buy and bill?
Joseph Gilliam - President, Chief Operating Officer
Joseph Gilliam - President, Chief Operating Officer
Yes, Michael, I, probably, won't go too far into the details around that. But obviously, there's always an ongoing education process around from our reimbursement teams and the experts within that as well as some of our site-of-care teams and the like to make sure those customers understand how the buyable process will work, the key terms and conditions that we have in terms of our payment terms and things like that to make sure that we can enable that where customers ultimately choose to buy and bill the drug. Obviously, when they think about it from a business standpoint, that can be an attractive option to them when they've got the right building blocks in place to enable buy and bill activity.
是的,Michael,我大概不會深入談太多細節。不過很明顯地,我們的給付/報銷團隊以及相關領域的專家,還有我們的一些照護場域(site-of-care)團隊等,會持續進行教育溝通,確保客戶了解「先買後請款(buy-and-bill)」流程將如何運作、我們在付款條款等方面的關鍵條款與條件等,以便在客戶最終選擇自行採購並向保險請款藥品時,我們能夠促成並支持這件事。顯然,從商業角度來看,當他們具備正確的基礎要件以推動 buy-and-bill 活動時,這對他們而言可能是一個具吸引力的選項。
Michael Sarcone - Analyst
Michael Sarcone - Analyst
Got it. Just a quick follow-up on iDose Trio. What's the latest and greatest there in terms of time lines and where we stand.
了解。再快速追問一下 iDose Trio。就時程與目前進度而言,最新狀況是什麼?
Thomas Burns - Chairman of the Board, Chief Executive Officer
Thomas Burns - Chairman of the Board, Chief Executive Officer
Yes, I'd be happy to address that, Michael. The -- as we said before, we would complete and we have completed the clinical study for iDose Trio. We'll monitor those patients over the course of this year. We plan to file by the end of this year, and we expect to be in position for targeted approval in the fourth quarter of 2027. So we're hitting on all marks in all cylinders.
好的,Michael,我很樂意回應。正如我們先前所說,我們將完成、而且也已經完成 iDose Trio 的臨床研究。今年我們會持續追蹤這些病患。我們計畫在今年底前遞交申請,並預期在 2027 年第四季達到目標核准的條件與位置。因此我們各項里程碑都在按計畫推進、進展順利。
And as we talked about before, when we did our human factors analysis, we saw a real strong preference for this new design on the order of 90%. So we're encouraged about what we think we'll be able to bring to the marketplace. And more encouraged by the ability to drive in-office use over time.
另外如同我們之前談到的,在進行人因(human factors)分析時,我們看到對這個新設計有非常強烈的偏好,比例約 90%。因此我們對於能帶到市場上的產品很受鼓舞,也更看好其隨時間推進、帶動院內(in-office)使用的能力。
Operator
Operator
Joanne, Citi.
Joanne,花旗(Citi)。
Joanne Wuensch - Analyst
Joanne Wuensch - Analyst
Can you hear me okay?
你聽得到我嗎?
Joseph Gilliam - President, Chief Operating Officer
Joseph Gilliam - President, Chief Operating Officer
We can.
聽得到。
Joanne Wuensch - Analyst
Joanne Wuensch - Analyst
Excellent. Now when we do some of our due diligence on IDS, Physicians are still pushing back or pushing back, maybe still is a wrong word, on the price tag of it. And honestly, I'm a little confused by that since you do have the J-code and you do have the reimbursement in place. So I'm sort of curious what your initial reinterested like and what the responsive to that.
太好了。我們在對 IDS 做一些盡職調查時,醫師仍然對它的價格標籤有所反彈——或許「仍然」這個詞不太精準。老實說我有點困惑,因為你們已經有 J-code,也已經建立了給付/報銷機制。所以我想了解你們最初的回饋/反應大概是什麼,以及你們如何回應這些意見。
Joseph Gilliam - President, Chief Operating Officer
Joseph Gilliam - President, Chief Operating Officer
Yes, Joanne, I think -- I mean, you'll always have customers with varying views, but I'm not so sure that, that's really a material of a driver today as it was when we launched. Any time you launch a pharmaceutical like we have with iDose or Epioxa. There's a period where you have to make sure that your customers understand the why and how, right?
是的,Joanne,我想——我的意思是,客戶的看法本來就會有所不同,但我不太確定這在今天是否仍像我們上市初期那樣,是一個實質的驅動因素。任何時候你推出像 iDose 或 Epioxa 這樣的藥品,都會有一段期間需要確保客戶理解「為什麼」以及「怎麼做」,對吧?
But at this point, sure, there will always be some of that. But for the vast majority of the customers, certainly, you can see with the results, we continue to add them and drive that forward. We can continue to overcome that challenge where it represents itself.
但就目前而言,當然仍會有一些這類情況。不過對絕大多數客戶來說,你也可以從結果看出來,我們持續新增客戶並推動進展。我們也能持續克服這項挑戰,在它出現的地方加以解決。
Operator
Operator
Steven Lichtman, William Blair.
Steven Lichtman,William Blair。
Steven Lichtman - Equity Analyst
Steven Lichtman - Equity Analyst
Just a couple of quick ones on Epioxa. First, as it relates to the transition from Photrexa, are you still anticipating it Photrexa to fully sunset by the end of 3Q? Or has there been any change in that plan?
關於 Epioxa 我有兩個簡短問題。第一,關於從 Photrexa 的轉換,你們是否仍預期 Photrexa 會在第三季末前完全退場(sunset)?或這個計畫有任何變動?
Joseph Gilliam - President, Chief Operating Officer
Joseph Gilliam - President, Chief Operating Officer
No change and consistent with what we've communicated to our customers that we would expect in the third quarter to have that transition taking place. And ultimately, we will have Photrexa available in limited quantities through a different mechanism where their physician may require an epi off-based procedure thereafter. But I wouldn't call that out as a real material consideration for certainly the commercial aspects of it for you all. But for those physicians who seek ongoing access to Photrexa. We do have a pathway which we're going to make it available then.
沒有變動,且與我們對客戶所溝通的一致:我們預期在第三季會進行該轉換。最終,我們仍會透過不同機制,以有限數量提供 Photrexa,供之後仍需要以 Photrexa 為基礎(based)的處置流程之醫師使用。但我不會把這視為你們在商業面模型中需要特別納入的重要因素。不過對於希望持續取得 Photrexa 的醫師,我們確實有一條途徑,屆時會讓其可取得。
Steven Lichtman - Equity Analyst
Steven Lichtman - Equity Analyst
Great. And then obviously, we're at the beginning of the runway with Epioxa in the US, but just thinking longer term, what is the potential for expansion of your platforms outside of the US, whether it's Photrexa or with Epioxa.
很好。接著,顯然 Epioxa 在美國才剛起步,但從更長期來看,你們的平台在美國以外的擴張潛力如何?不論是 Photrexa 或 Epioxa。
Joseph Gilliam - President, Chief Operating Officer
Joseph Gilliam - President, Chief Operating Officer
Yes. I think it's -- it has to be much more selective, and it won't surprise you, Steven that today's environment where you're navigating a combination of reference-based pricing initiatives as well as other things in terms of payer dynamics and the like. There are certainly some markets internationally that can support the type of therapies that we're talking about with Epioxa and with iDose.
是的。我認為——必須更有選擇性。而且不會讓你意外,Steven,在當前環境下,你需要同時因應參考定價(reference-based pricing)倡議,以及付款方動態等其他因素。國際上確實有一些市場能支持我們所談的這類療法,包括 Epioxa 與 iDose。
But also, we'll have to continue to evaluate that as the landscape shifts that we bring success for generations of products forward. and bring as much of this technology over time as we can internationally. But it's not something that at the moment I would be factoring in any material way into your models.
但同時,隨著環境變化,我們也必須持續評估;在我們推進一代又一代產品成功的同時,盡可能把這些技術逐步帶到國際市場。不過就目前而言,我不會建議你們在模型中以任何實質方式把它納入考量。
Operator
Operator
Anthony Petrone, Mizuho Group.
Anthony Petrone,瑞穗集團(Mizuho Group)。
Anthony Petrone - Analyst
Anthony Petrone - Analyst
Congrats on the quarter. Maybe one on just keratoconus just broadly, when you think about the disease state that it's just -- it's underdiagnosed you're getting most of these patients that come in with Stage 2 severity, just thinking about the Epioxa opportunity, what is the really true TAM from a patient standpoint in terms of this disease state?
恭喜本季表現。我想問一個關於圓錐角膜(keratoconus)的問題:整體來看,這個疾病狀態被低估診斷(underdiagnosed),你們目前看到的大多數病患是在第二期嚴重度才進來。就 Epioxa 的機會而言,從病患角度來看,這個疾病狀態真正的 TAM(可服務總市場)到底有多大?
I know it's kind of considered an orphan disease, but I think the prevalence probably stretches to somewhere between 80,000 and 100,000 patients. So what is the true TAM in terms of prevalence in the US? And what is the diagnostic pathway to get more patients into the funnel?
我知道它通常被視為罕見疾病(orphan disease),但我認為盛行率可能落在 80,000 到 100,000 名病患之間。所以在美國,就盛行率而言真正的 TAM 是多少?以及要讓更多病患進入漏斗(funnel),診斷路徑是什麼?
Joseph Gilliam - President, Chief Operating Officer
Joseph Gilliam - President, Chief Operating Officer
I think, Anthony, it's a great question in the context of exactly the why behind what we're trying to achieve here. So when you think about keratoconus and as a condition in where we've been, the 18,000 to 20,000 eyes that happen getting treated, we believe is likely going to be proven to be a fraction of what really should be getting caught should be driven to detection and ultimately into therapy over time.
Anthony,我認為這是個很好的問題,也正切中我們想在這裡達成目標背後的「為什麼」。當你思考圓錐角膜這個狀況,以及我們過去所處的情境——每年大約有 18,000 到 20,000 只眼睛接受治療——我們相信,這很可能只是實際應該被發現、應該被推動去檢出,並最終隨時間進入治療的一小部分。
I think our best estimates here suggests that there should be between 50,000 and 100,000 keratoconic eyes a year at a minimum that are getting diagnosed and treated with Epioxa cross-linking. And -- but we're going to have to find that number out ourselves as we move forward with increased debt initiatives around awareness and detection and ultimately access that therapy.
我們目前最好的估計顯示,每年至少應該有 50,000 到 100,000 只圓錐角膜眼在一年內被診斷,並接受 Epioxa 角膜交聯(cross-linking)治療。不過,隨著我們推動更多在提升認知與檢出、以及最終取得治療(access)方面的投入與倡議,我們也必須在前進過程中自行把這個數字更精準地找出來。
But we do believe that over time that this could be proven to be more of a rarely diagnosed disease than a rare disease. But today, it operates like a rare disease and we're going to make those investments accordingly.
但我們確實相信,隨著時間推進,這可能會被證明更像是「罕被診斷的疾病」而非「罕見疾病」。不過在今天,它的運作方式仍像罕見疾病,我們也會據此進行相應投資。
Operator
Operator
With no further questions in queue, I will now hand the call back over to Glaukos Corporation for closing remarks.
目前佇列中沒有其他問題,我現在把電話交回 Glaukos Corporation 進行結語。
Thomas Burns - Chairman of the Board, Chief Executive Officer
Thomas Burns - Chairman of the Board, Chief Executive Officer
Okay. I want to thank you all for your time and for your attention today, and thank you as well for your continued interest and support of Glaukos. Goodbye.
好的。感謝各位今天撥冗與專注聆聽,也謝謝各位持續關注並支持 Glaukos。再見。
Operator
Operator
Thank you again for joining us today. This does conclude today's conference call. You may now disconnect.
再次感謝各位今天加入。本次電話會議到此結束。您現在可以掛線。