IRIDEX Corp (IRIX) 2023 Q3 法說會逐字稿

Good day and thank you for standing by. Welcome to the Q3 2023 Iridex earnings conference call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Trip Taylor, Investor Relations.

美好的一天，感謝您的支持。歡迎參加 2023 年第三季 Iridex 財報電話會議。 （操作員指示）請注意，今天的會議正在錄製中。現在，我想將會議交給今天的演講者，投資者關係部門 Trip Taylor。

Thank you, and thank you all for participating in today's call. Joining me are David Bruce, Chief Executive Officer, and Fuad Ahmad, Interim Chief Financial Officer. Earlier today, Iridex released financial results for the quarter ended September 30, 2023. A copy of the press release is available on the company's website.

謝謝大家，也謝謝大家參加今天的電話會議。與我一起的還有執行長 David Bruce 和臨時財務長 Fuad Ahmad。今天早些時候，Iridex 發布了截至 2023 年 9 月 30 日的季度財務業績。新聞稿的副本可在該公司網站上取得。

Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements made during this call, are not statements -- that are not statements of historical fact, including but not limited to, statements concerning our strategic goals and priorities, product development matters, sales trends in the markets in which we operate.

在我們開始之前，我想提醒您，管理層將在本次電話會議期間發表聲明，其中包括聯邦證券法含義內的前瞻性聲明，這些聲明是根據美國《私人證券訴訟改革法案》的安全港條款制定的。1995 年。本次電話會議期間所做的任何聲明都不是聲明，也不是歷史事實的聲明，包括但不限於有關我們的戰略目標和優先事項、產品開發事項、我們經營所在市場的銷售趨勢的聲明。

All forward-looking statements are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place reliance on these statements.

所有前瞻性陳述均基於我們目前的估計和各種假設。這些陳述涉及重大風險和不確定性，可能導致實際結果或事件與這些前瞻性陳述預期或暗示的結果或事件有重大差異。因此，您不應依賴這些陳述。

For a discussion of the risks and uncertainties associated with our business, please visit -- please see the most recent Form 10-K and Form 10-Q filings with the SEC. Iridex disclaims any intention or obligation, except as required by law to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise.

如需討論與我們業務相關的風險和不確定性，請造訪 - 請參閱向 SEC 提交的最新 10-K 表格和 10-Q 表格文件。 Iridex 不承擔任何意圖或義務，除非法律要求更新或修改任何財務預測或前瞻性陳述，無論是因為新資訊、未來事件或其他原因。

This conference call contains time-sensitive information and is accurate only as of the live broadcast today, November 14, 2023. And with that, I'll turn the call over to Dave.

本次電話會議包含時間敏感信息，並且僅截至今天（2023 年 11 月 14 日）直播時準確。接下來，我會將電話轉給 Dave。

Good afternoon. Thanks, Tripp, and thank you all for joining us. Today, I'll discuss recent corporate and Medicare reimbursement developments in our business progress. Then Fuad will provide details on the third quarter financials, and we will open the call for questions.

午安.謝謝特里普，也謝謝大家加入我們。今天，我將討論我們業務進展中最近的企業和醫療保險報銷發展。然後福阿德將提供有關第三季度財務狀況的詳細信息，我們將開始提問。

I'll start with the topic I expect people are most interested in learning more about, that's the Medicare coverage policy, that was the subject of our recent 8-K and the potential impacts to our business. on October 26, WPS, a Medicare administration contractor, or MAC, was the first to issue an LCD changing its coverage related to minimally invasive glaucoma surgery or MIGS procedures.

我將從我希望人們最有興趣了解更多的主題開始，那就是醫療保險覆蓋政策，這是我們最近 8-K 的主題以及對我們業務的潛在影響。 10 月 26 日，醫療保險管理承包商 WPS（MAC）率先發布 LCD，更改其與微創青光眼手術或 MIGS 手術相關的承保範圍。

Last week, as expected, four other MACs released similar LCDs and all will become effective December 24, 2023. While the clear focus of the five LCDs was MIGS device use, they also changed their coverage criteria for a cyclophotocoagulation or CPC, which is the basis for Iridex's MicroPulse and continuous wave glaucoma procedures.

上週，正如預期的那樣，其他四個MAC 發布了類似的LCD，所有這些都將於2023 年12 月24 日生效。雖然這五個LCD 的明確重點是MIGS 設備的使用，但它們也更改了睫狀體光凝術或CPC 的覆蓋標準，這是Iridex 的微脈衝和連續波青光眼手術的基礎。

While MIGS or incisional surgical procedure is predominantly done coincident to a cataract surgery, the CPC procedure is done with Iridex devices are neither incisional, nor are they commonly done coincident to cataract surgery. While the MACs provided little context or explanation for their motive and coverage changes, it's believed they were reacting to the rapid rise in volume and cost of MIGS procedures, particularly driven by multiple MIGS devices deployed during one cataract intervention.

MIGS 或切口手術主要與白內障手術同時進行，而 CPC 手術則使用 Iridex 裝置進行，既不是切口手術，也通常不與白內障手術同時進行。雖然MAC 對其動機和覆蓋範圍變化幾乎沒有提供任何背景或解釋，但據信，他們是對MIGS 手術數量和成本迅速上升做出的反應，特別是在一次白內障幹預期間部署的多個MIGS 設備推動下。

This drove an increase in surgeon submitting multiple billing codes and a large increase in reimbursement expense per procedure, and in total. The LCDs limit MIGS procedures concomitant with cataract surgery to a single device and specifically call out newer MIGS devices that enable both canaloplasty and goniotomy procedure to be performed with a single device. These and several other procedures were labeled as investigational, which means they were made ineligible for Medicare reimbursement until more rigorous clinical work on effectiveness is published.

這導致外科醫生提交多個帳單代碼的數量增加，並且每次手術的報銷費用和總額大幅增加。 LCD 將白內障手術伴隨的 MIGS 程序限制為單一設備，並特別指出了較新的 MIGS 設備，這些設備可以使用單一設備執行管道成形術和前房角切開術。這些程序和其他幾個程序被標記為研究性程序，這意味著在發布更嚴格的有效性臨床研究之前，它們沒有資格獲得醫療保險報銷。

The LCDs confirmed that cycle photocoagulation received continuing payment coverage. Unlike the targeted MIGS procedures, CPC is not labeled as investigational. However, the coverage criteria for CPC was redefined via an extensive list of patient characteristics and symptoms that would effectively limit reimbursement to procedures performed on patients suffering from very advanced stage glaucoma.

LCD 證實週期光凝術已獲得持續支付。與目標 MIGS 程序不同，CPC 沒有被標記為研究性程序。然而，CPC 的承保標準是透過廣泛的患者特徵和症狀清單重新定義的，這將有效限制對患有非常晚期青光眼的患者進行的手術的報銷。

For our business on patients enrolled in these restricted coverage MACs, this means fewer MicroPulse DLT procedures and stricter limitations for continuous wave CPC procedures. So how many fewer procedures?

對於我們在這些受限覆蓋 MAC 中登記的患者業務來說，這意味著 MicroPulse DLT 程序更少，而連續波 CPC 程序的限制更嚴格。那麼少了多少道工序呢？

Let me run through the numbers to get a sense of what impact the LCDs might have on Iridex's glaucoma revenue. And note there's still a high degree of uncertainty. We believe the following classifications and assumptions represent the situation.

讓我透過這些數字來了解 LCD 可能對 Iridex 的青光眼收入產生什麼影響。請注意，仍然存在高度的不確定性。我們認為以下分類和假設代表了這種情況。

First, half of Iridex's glaucoma revenue is international and unaffected. Further, two of the seven total MAC payers in the United States have not issued a change to their cyclophotocoagulation coverage. And these MACs cover about one-third of our US footprint, including key states like Florida, Texas, and Pennsylvania.

首先，Iridex 一半的青光眼收入來自國際市場，不受影響。此外，美國七個 MAC 付款人中有兩個尚未更改其睫狀體光凝術承保範圍。這些 MAC 涵蓋了我們約三分之一的美國業務，包括佛羅裡達州、德克薩斯州和賓夕法尼亞州等關鍵州。

To be clear, CPC is still covered in all the MACs. The procedure is just now subject to restrictions narrowing its coverage in five of seven MACs. So the American Glaucoma Society estimates that approximately 60% of US glaucoma patients are covered by Medicare. Our procedures are performed on moderate to advanced severity, probably skews a little bit older. So we estimate about 70% of our volume has Medicare coverage.

需要明確的是，CPC 仍然包含在所有 MAC 中。該程式目前受到限制，其覆蓋範圍縮小到七個 MAC 中的五個。因此，美國青光眼協會估計，大約 60% 的美國青光眼患者享有醫療保險。我們的手術是在中度到高級的嚴重程度下進行的，可能有點偏舊。因此，我們估計大約 70% 的銷售量有醫療保險覆蓋。

However, within Medicare, about half of patients are covered by these MACs network of payers and half are in Medicare Advantage programs which are administered by traditional insurance companies like Aetna and UnitedHealthcare. Currently, none of the MAC Advantage or Medicare Advantage payors have altered their coverage for CPC, even as they've issued new updates for their MIGS coverage criteria.

然而，在 Medicare 範圍內，大約一半的患者受到這些 MAC 付款人網絡的覆蓋，一半患者參加了由 Aetna 和 UnitedHealthcare 等傳統保險公司管理的 Medicare Advantage 計劃。目前，MAC Advantage 或 Medicare Advantage 付款人均未更改其 CPC 承保範圍，即使他們發布了 MIGS 承保標準的新更新。

At this time, Iridex cannot accurately predict the impact these LCD coverage changes will have on its US glaucoma probe or system business. The math implies about 20% of US procedures fall directly under the MAC coverage restrictions, with our glaucoma procedures for the most severe patients the least affected and those for more moderate stage being most effected.

目前，Iridex 無法準確預測這些 LCD 覆蓋範圍變化將對其美國青光眼探頭或系統業務的影響。數學表明，大約 20% 的美國手術直接受到 MAC 覆蓋限制的限制，我們針對最嚴重患者的青光眼手術受影響最小，而針對較中等階段患者的青光眼手術受影響最大。

At this time, it's uncertain how physicians will react to coverage reductions and their decisions to offer our treatment of patients. We've heard many doctors, particularly during the recently held American Academy of Ophthalmology in San Francisco, that CPC is not only proven and effective, but an essential part of their treatment program for controlling the progression of glaucoma for their patients. These physicians communicated their strong intention to continue performing CPC and several doctors discuss the possibility of offering patients for whom CPC is obviously the best next treatment, and option for self-pay at coverage isn't available under their plan.

目前，尚不確定醫生將如何應對承保範圍的減少以及他們為患者提供治療的決定。我們聽到許多醫生，特別是最近在舊金山舉行的美國眼科學會期間，他們表示，CPC 不僅被證明有效，而且是控制患者青光眼進展的治療計劃的重要組成部分。這些醫生表達了他們繼續進行 CPC 的強烈意願，並且幾位醫生討論了為患者提供 CPC 顯然是最好的下一步治療的可能性，並且根據他們的計劃不提供自費承保選項。

Qualitatively, there are two important competing considerations: first, there's going to be physician confusion and frustration surrounding these reimbursement changes in the effective MAC states. We expect the coverage restrictions will result in many of our potential prospects, deferring adoption, leading to fewer domestic orders for consoles and probes as providers work through the confusion around what has changed and who's affected and how they will position CPC in their practice.

從品質上來說，有兩個重要的相互競爭的考慮因素：首先，在有效的 MAC 州，醫生會對這些報銷變化感到困惑和沮喪。我們預計，覆蓋範圍限制將導致我們的許多潛在客戶推遲採用，從而導致國內控制台和探頭訂單減少，因為供應商正在努力解決哪些變化、受影響的人以及他們將如何在實踐中定位 CPC。

In affected MAC regions, doctors may not be aware of an individual patient's coverage and to whom they can offer our procedures and generally pull back usage to avoid non-reimbursed procedures.

在受影響的 MAC 地區，醫生可能不知道個別患者的承保範圍以及他們可以向誰提供我們的手術，並且通常會減少使用以避免無報銷的手術。

On the other hand, there are some potential positives for Iridex. MIGS are big deal in the glaucoma community right now. And the LCDs are receiving a lot of attention. And this includes physicians wrestling with their options going forward in treating the disease. Ironically, with LCDs falling hardest on MIGS and thereby almost certainly reducing the number of MIGS procedures that will be performed, there should be greater need, recognition, and interest in non-incisional alternatives. This is a marketing opportunity that plays right into Iridex's existing positioning on glaucoma.

另一方面，Iridex 也有一些潛在的正面因素。 MIGS 目前在青光眼界是一件大事。 LCD 也受到了廣泛關注。這包括醫生在治療這種疾病的過程中苦苦思索。諷刺的是，由於 LCD 在 MIGS 上表現最差，幾乎肯定會減少將要執行的 MIGS 手術數量，因此對非切口替代方案應該有更大的需求、認可和興趣。這是一個行銷機會，正好符合 Iridex 在青光眼方面的現有定位。

The LCD's effort to reduce the number of MIGS procedures may ultimately trigger the longer-term effect of significantly improving the market opportunity for our CPC offerings, both in the US and OUS. Ophthalmologists that have long been caught up in growing assortment and uptake of MIGS may be more open to Iridex's not incisional alternative.

LCD 減少 MIGS 程序數量的努力可能最終會產生顯著改善我們的 CPC 產品在美國和海外市場機會的長期影響。長期以來一直關注 MIGS 品種不斷增加和使用的眼科醫生可能對 Iridex 的非切開替代方案持更開放的態度。

And beyond working to appeal the LCD coverage restrictions, Iridex will have the opportunity to position itself as a champion for patients, physicians, and pursuing the best medicine. Many clinicians have commented to us that it's a mistake to channel patients toward more advanced surgical procedures too early. It's basic disease management to defer more complicated, higher risk surgeries as late as feasible.

除了努力上訴 LCD 承保限制之外，Iridex 將有機會將自己定位為患者、醫生和追求最佳藥物的捍衛者。許多臨床醫生向我們評論說，過早引導患者接受更先進的外科手術是錯誤的。盡可能推遲更複雜、風險更高的手術是基本的疾病管理。

On top of that, there are many patients where surgery may not be indicated. This includes older, poor health candidates and the younger, otherwise healthy individuals for whom a glaucoma surgery in their 40s, 50s and 60s can be complication prone and lifestyle limiting, and may also result in decades of more involved and expensive follow-up.

最重要的是，有許多患者可能不適合手術。這包括年齡較大、健康狀況不佳的候選人和較年輕、其他方面健康的人，對於他們來說，40 多歲、50 多歲和60 多歲的青光眼手術可能容易出現併發症並限制生活方式，也可能導致數十年的更複雜和更昂貴的追蹤。

We believe we have a strong case to appeal the specifics of the LCDs and we're gaining and gathering support within the physician community. We've submitted the first phase of our appeal, working with several influential physicians, some of who plan their own letters and reference studies explaining why overly restricting CPC is a mistake.

我們相信我們有充分的理由來訴諸 LCD 的細節，而我們正在獲得並聚集醫生界的支持。我們已經與幾位有影響力的醫生合作，提交了第一階段的上訴，其中一些醫生計劃了自己的信件和參考研究，解釋為什麼過度限制 CPC 是一個錯誤。

The final LCDs ultimately set the criteria for CPC patient characteristics by partially adopting conclusions from an AAO technology assessment report that is 22 years old. We believe they erred by setting compounding criteria for coverage, resulting an overly narrow patient qualifications. They also erred by only choosing some of the recommendations from that assessment and ignoring others.

最終的 LCD 透過部分採用 22 年前的 AAO 技術評估報告的結論，最終設定了 CPC 患者特徵的標準。我們認為他們錯誤地制定了複雜的覆蓋標準，導致患者資格過於狹窄。他們也犯了錯誤，只選擇了評估中的一些建議，而忽略了其他建議。

The conclusion of that assessment by the AAO presented a list of several patient types for which CPC is indicated as appropriate treatment options. The LCDs quoted this list of symptoms and characteristics, but replaced the common between them with the word and, the resulting effect means that to qualify a patient must have all of the characteristics of each listed patient type. This appears clearly wrong.

AAO 的評估結論列出了幾種患者類型，CPC 被認為是適當的治療選擇。 LCD 引用了此症狀和特徵列表，但用「and」一詞替換了它們之間的共同點，由此產生的效果意味著要使患者符合資格，必須具有每種列出的患者類型的所有特徵。這顯然是錯誤的。

We sent a correction request, noting the process errors and seeking rapid adjustment to the definition. We believe this appeal is compelling and should -- emphasis on the word should -- lead to a relatively speedy correction of the LCDs to lessen the successive restriction of coverage for CPC.

我們發送了更正請求，指出了流程錯誤並尋求快速調整定義。我們相信這項呼籲是令人信服的，並且應該——強調「應該」這個詞——導致對 LCD 進行相對較快的修正，以減輕對 CPC 承保範圍的連續限制。

We believe the era of interpretation embodied in the current wording, if uncorrected, will lead to unrecoverable loss of vision in patients who may be denied access because of the erroneous restriction. We urged each MAC administrator to promptly correct this error before the effective date. We're also preparing a subsequent appeal for reconsideration to further broaden the criteria for reimbursement.

我們認為，當前措辭所體現的解釋時代，如果不加以糾正，將導致患者出現不可恢復的視力喪失，並可能因錯誤的限製而被拒絕就診。我們敦促每位 MAC 管理員在生效日期之前及時糾正此錯誤。我們也準備隨後提出重新考慮的上訴，以進一步擴大報銷標準。

First, the coverage change did not appear to take into account patient safety, by requiring a patient must have undergone more invasive, higher complication rate surgeries like trabeculectomy or tube shunts. By pushing patients into earlier invasive surgeries, greater follow-up management is required, later life options will be more limited. Basically, if you use up your IOP control tools too early, it can lead to greater loss of vision later in life.

首先，承保範圍的變化似乎沒有考慮到患者的安全，因為要求患者必須接受過更具侵入性、併發症發生率更高的手術，如小梁切除術或管分流術。透過促使患者更早進行侵入性手術，需要更多的後續管理，後期的生活選擇將更加有限。基本上，如果您過早用完眼壓控制工具，可能會導致以後的視力損失更大。

Second, the process for considering study evidence was flawed. We have a large body of peer-reviewed clinical studies to support our procedures in a broad range of patient types and severities. This past summer, we submitted to the MACs over 80 published papers on transscleral cyclophotocoagulation, treating over 2,000 patients. It appears their process criteria rejected most of this evidence. Instead, we will seek them to consider the broader body of evidence that supports the safety and efficacy of cyclophotocoagulation.

其次，考慮研究證據的過程有缺陷。我們擁有大量經過同行評審的臨床研究來支持​​我們針對各種患者類型和嚴重程度的手術。去年夏天，我們向 MAC 提交了 80 多篇關於經鞏膜睫狀體光凝術的論文，治療了 2,000 多名患者。看來他們的流程標準拒絕了大部分證據。相反，我們將尋求他們考慮支持睫狀體光凝術安全性和有效性的更廣泛的證據。

So this lead straight into updating our ongoing clinical programs. As we've discussed prior, we had planned to enroll the first patient by the end of the year in our new prospective multicenter study that will include key opinion leaders as investigators. This release of new clinical criteria within the LCDs will potentially cause a modest delay in the launch as we assess whether our protocol and method are best aligned, but we're nonetheless fortunate to already be well on the road toward producing the clinical data they have stated as required for future reimbursement decision considerations.

因此，這直接導致我們正在進行的臨床計劃的更新。正如我們之前討論的，我們計劃在今年年底前在我們新的前瞻性多中心研究中招募第一位患者，該研究將包括關鍵意見領袖作為研究人員。 LCD 中新臨床標準的發布可能會導致發布略有延遲，因為我們評估我們的方案和方法是否最一致，但我們很幸運，已經在生成他們所擁有的臨床數據的道路上走得很好根據未來報銷決策考慮的需要進行說明。

Having glaucoma physicians rally in support of Iridex CPC, at the same time, we're finalizing preparation for clinical study on efficacy of CPC specifically targeted to post-MIGS patients seems very favorable. We'll try to advance our message and market position by capitalizing on the opportunity and attention created by the LCDs. We have confidence the efficacy and safety of our procedures will prevail and the increased clinician awareness generated through this process can provide exposure and positive Public Relations at a scale we could never have afforded.

青光眼醫生團結起來支持 Iridex CPC，同時，我們正在完成專門針對 MIGS 後患者的 CPC 療效臨床研究的準備工作，這似乎非常有利。我們將努力利用液晶顯示器帶來的機會和關注來提升我們的訊息和市場地位。我們相信，我們的程序的有效性和安全性將會佔上風，並且透過此過程產生的臨床醫生意識的提高可以以我們永遠無法承受的規模提供曝光和積極的公共關係。

Let me shift to recent announcements that the Board of Directors is engaged in a review and evaluation of strategic alternatives that may be available to Iridex to unlock shareholder value. This is an appropriate time for the company to explore options for future of each of our product lines and the company as a whole.

讓我談談最近的公告，董事會正在審查和評估 Iridex 可用於釋放股東價值的策略替代方案。現在是公司探索每條產品線和整個公司未來選擇的合適時機。

Our retina business has achieved a global leadership position in both sales and installed base in ophthalmic laser treatment systems for retina specialists. Over the past 30 years, the company has developed products and has set the clinical and technical standards in the space. Most recently, we launched the new PASCAL platform with MicroPulse capability.

我們的視網膜業務在視網膜專家眼科雷射治療系統的銷售和安裝基礎上都取得了全球領先地位。過去 30 年來，該公司不斷開發產品，並制定了該領域的臨床和技術標準。最近，我們推出了具有 MicroPulse 功能的新 PASCAL 平台。

In glaucoma, we've been a leading provider of non-incisional transscleral laser treatment beginning 30 years ago with the G-Probe cyclophotocoagulation treatment for later stage glaucoma patients and more recently with MicroPulse transscleral laser therapy for moderate to advanced stage glaucoma patients. Since launching MPTLT, we steadily expanded our market presence to over 2,000 glaucoma laser consoles worldwide, and delivered over 250,000 single-use probes.

在青光眼領域，我們從30 年前開始為晚期青光眼患者提供G-Probe 睫狀體光凝治療，一直是非切開經鞏膜激光治療的領先提供商，最近又為中晚期青光眼患者提供MicroPulse 經鞏膜激光治療。自推出 MPTLT 以來，我們穩步將市場份額擴大到全球 2,000 多個青光眼雷射控制台，並交付了超過 250,000 個一次性探頭。

Both our revenue and product offerings are the strongest they've ever been. We're progressing through our process, but do not plan to provide commentary or updates along the way until the Board of Directors determines that disclosure is appropriate.

我們的收入和產品供應都是有史以來最強勁的。我們正在推動我們的流程，但在董事會確定披露適當之前，不打算提供評論或更新。

Before I turn over to Fuad for a review of the third quarter financials, I'd like to add a couple of items of perspective. The quarter was in line sequentially, which is positive, given Q3 is generally seasonally softer than the second quarter. This quarter was tougher year-over-year comparison against a strong third quarter of 2022, especially given the losses from expirations.

在請福阿德審查第三季財務狀況之前，我想補充一些觀點。該季度與上一季持平，這是積極的，因為第三季整體季節性比第二季疲軟。與強勁的 2022 年第三季相比，本季的年比情況更加嚴峻，特別是考慮到到期造成的損失。

We expected the announcement of our strategic review might have impacted short-term results. But fortunately, we saw a little of this domestically and it was primarily our distributors that held back orders concerned about appropriate levels of inventory to carry going forward. As a result of the Medicare reimbursement changes, we've suspended our guidance due to the high variability of the US glaucoma situation and how our business may unfold in Q4 and going into 2024.

我們預期策略審查的宣布可能會影響短期業績。但幸運的是，我們在國內看到了一些這種情況，主要是我們的經銷商因擔心繼續保持適當的庫存水準而推遲了訂單。由於醫療保險報銷的變化，由於美國青光眼情況的高度可變性以及我們的業務在第四季度和進入 2024 年的發展情況，我們暫停了我們的指導。

We remain very focused on cash management to remain our operating runway and intend to adjust our glaucoma operations as we evaluate the impact to our business from these reimbursement changes.

我們仍然非常注重現金管理，以保持我們的營運跑道，並打算在評估這些報銷變化對我們業務的影響時調整我們的青光眼業務。

With that, I'll pass the call over to Fuad to discuss the quarter's financial results.

接下來，我會將電話轉給福阿德，討論本季的財務表現。

Thanks, Dave, and good afternoon, everyone, and thank you for joining us today. I would like to begin by reviewing our financial performance for Q3 of fiscal 2023.

謝謝戴夫，大家下午好，謝謝你們今天加入我們。我想先回顧一下我們 2023 財年第三季的財務表現。

Let me start by providing a high level summary. We generated $12.9 million in total revenue in Q3, which was flat sequentially versus Q2. Important because it is typically a seasonally slower quarter. However, it was down $1.8 million from the prior period, continuing the overall softness in capital equipment market in '23, a significant part of the decline, approximately 500,000 was due to loss in royalty revenue as we previously mentioned. And this will be a drag until we lap it next year on both the G6 and retina side of the business, the macroeconomic -- the macro and the probe adoption headwinds in 2023, we discussed during the August second quarter results call continued to affect overall sales in Q3.

讓我先提供一個高層次的總結。第三季我們的總收入為 1,290 萬美元，與第二季持平。很重要，因為它通常是季節性放緩的季度。然而，它比上期下降了 180 萬美元，延續了 23 年資本設備市場的整體疲軟狀態，其中很大一部分下降，大約 50 萬美元是由於我們之前提到的特許權使用費收入損失。這將是一個拖累，直到我們明年在G6 和視網膜方面的業務、宏觀經濟方面——2023 年宏觀經濟和探針採用的逆風——我們在8 月第二季度業績電話會議上討論過，這將繼續影響整體第三季的銷售。

Our retina segment revenue in Q3 was $7.9 million compared to $8.8 million in the prior period. In the quarter, we continued to see stronger and longer capital sales cycles and strong dollar made pricing challenging internationally and has persisted throughout 2023. While these dynamics contributed to lower sales in retina systems, we aren't seeing customers cancel their capital purchase plans, and we are maintaining a solid pipeline and our strong market share in the US looks stable.

第三季我們的視網膜部門營收為 790 萬美元，而上一季的營收為 880 萬美元。在本季度，我們繼續看到更強勁、更長的資本銷售週期，以及強勢美元使國際定價面臨挑戰，並且這種情況在整個2023 年持續存在。雖然這些動態導致視網膜系統的銷售下降，但我們沒有看到客戶取消他們的資本購買計劃，我們正在保持穩固的產品線，我們在美國的強大市場份額看起來很穩定。

In glaucoma, system purchases were significantly slowed as capital sales were impacted by higher interest rates and economic certainty contributing to elongated sales cycles. This maintenance led to system sales of 27 units in the quarter compared to 54 systems in the prior year period. The system sales shortfall accounted for the declines in overall Q3 Cyclo G6 revenue to $3 million from $3.5 million last year. Overall, we saw glaucoma probe revenue increase 3%, but suffered a 3% decline in units, primarily due to order flow in international markets.

在青光眼領域，由於資本銷售受到利率上升和經濟確定性導致銷售週期延長的影響，系統採購顯著放緩。此次維護導致本季系統銷售量為 27 套，而去年同期為 54 套。系統銷售不足導致第三季 Cyclo G6 總營收從去年的 350 萬美元下降至 300 萬美元。總體而言，我們看到青光眼探頭收入增加了 3%，但數量下降了 3%，這主要是由於國際市場的訂單流。

International volumes were affected by loss of sales to Russia due to geopolitical issues and soft China sales as anti-corruption initiatives caused a stall in new adoption similar to what other companies are seeing. We also saw distributors reducing inventory levels in both frozen systems possibly as a result of our strategic announcement in August, but also to reduce carrying costs.

由於地緣政治問題和中國銷售疲軟，國際銷售受到了對俄羅斯銷售損失的影響，因為反腐敗舉措導致了新產品採用的停滯，類似於其他公司所看到的情況。我們還看到分銷商降低了兩個冷凍系統的庫存水平，這可能是我們八月戰略公告的結果，但也是為了降低持有成本。

Now to product level detail. Total revenue from Cyclo G6 product family in Q3 was $3 million, down 12% compared to the same period in 22. We sold 13,250 Cyclo G6 probes in Q3, representing revenue growth of 3% on higher ASPs on a negative 3% unit growth from the prior year period. We also saw 27 Cyclo G6 systems in the quarter compared to 54 in the prior year period.

現在到產品層級的詳細資訊。第3 季Cyclo G6 產品系列的總營收為300 萬美元，與22 年同期相比下降12%。第3 季我們售出了13,250 個Cyclo G6 探頭，平均售價提高，營收成長3%，單位數量負成長3%。上一年期間。本季我們也看到了 27 個 Cyclo G6 系統，而去年同期為 54 個。

Our retina product revenue in Q3 was $7.9 million, up 15% sequentially, but a 10% decline from the prior year period. Other revenue, which includes royalties, services, and other legacy products decreased 20% to $1.9 million in Q3 of '23 compared to the same period in '22, driven primarily by reduced royalty revenue of approximately $500,000 from expiration of license patents and lower than anticipated service and repair volume.

第三季我們的視網膜產品營收為 790 萬美元，比上一季成長 15%，但比去年同期下降 10%。與22 年同期相比，23 年第三季的其他收入（包括特許權使用費、服務和其他遺留產品）下降了20%，至190 萬美元，這主要是由於許可專利到期導致特許權使用費收入減少約50 萬美元以及低於預期的服務和維修量。

Gross profit for Q3 of '23 was $5.6 million compared to $6.5 million in the prior year period. Gross margin was 43.7% compared to 44.1% in Q3 of '22. The decline in gross margin was the result of lower overhead absorption in the current period and more favorable product mix in Q3 of '22. Operating expenses in Q3 of '23 were $7.3 million, a significant decrease compared to $8.2 million in the same period last year. The decrease in operating expenses is a result of cost reduction initiatives the company began in Q2 of '23. Our net loss in Q3 of '23 was $1.8 million or net loss of $0.11 per share compared to a net loss of $1.8 million and a net loss of $0.11 per share for the same period in '22.

23 年第三季的毛利為 560 萬美元，而去年同期為 650 萬美元。毛利率為 43.7%，而 22 年第三季為 44.1%。毛利率下降是由於本期管理費用吸收減少以及 22 年第三季更有利的產品組合所致。 2023 年第三季的營運費用為 730 萬美元，與去年同期的 820 萬美元相比大幅下降。營運費用的減少是該公司於 2023 年第二季開始的成本削減措施的結果。我們 23 年第三季的淨虧損為 180 萬美元，即每股淨虧損 0.11 美元，而 22 年同期的淨虧損為 180 萬美元，每股淨虧損為 0.11 美元。

I will now discuss our cash position and cash flows. The net cash reduction in the quarter was $1.8 million, (inaudible) with $8 million at quarter-end. We were successful with inventory reduction of $1.1 million, but we also reduced accounts payable by $1.7. Over the summer months, we significantly reduced our operating expense run rate by more than $3 million annualized. As a result, we are positioned for a significantly lower cash usage in Q4 and a substantially lower run rate in 2024.

我現在將討論我們的現金狀況和現金流。本季現金淨減少額為 180 萬美元（聽不清楚），季末現金減少額為 800 萬美元。我們成功地減少了 110 萬美元的庫存，同時也減少了 1.7 美元的應付帳款。在夏季的幾個月裡，我們大幅降低了年營運費用超過 300 萬美元。因此，我們預計第四季度的現金使用量將大幅降低，2024 年的運行率將大幅降低。

We will remain focused on expense management and operating efficiencies in coming quarters as we continue to unwind the inventory related investments and manage cost to mitigate US (inaudible) Cyclo probe revenue from reimbursements limitations.

我們將在未來幾季繼續關注費用管理和營運效率，因為我們將繼續減少與庫存相關的投資並管理成本，以減輕美國（聽不清楚）Cyclo 探頭收入因報銷限製而帶來的影響。

Finally, as we previously reported, in light of the ongoing ambiguity related to Medicare reimbursement picture for our glaucoma procedures, we are withdrawing our fiscal 2023 guidance. We will provide a comprehensive update when we have more clarity on the matter.

最後，正如我們之前所報道的那樣，鑑於青光眼手術的醫療保險報銷情況持續存在模糊性，我們將撤回 2023 財年指引。當我們對此事有更清晰的了解時，我們將提供全面的更新。

With that, Dave and I would like to turn the call over to the operator for questions. Operator?

這樣，戴夫和我想將電話轉給接線員詢問問題。操作員？

(Operator Instructions) Tom Stephan, Stifel.

（操作員說明）Tom Stephan，Stifel。

Great. Hey, guys. Thanks for the questions. I'll start with LCDs. Just a couple here. Dave, what's the mix of moderate versus severe patients for Cyclo G6 today? I think in the past, you've talked about moderate being a very large opportunity for G6, as it was maybe no more than 25% of volume today. So I guess the majority of your volume is that refractory patients. I'm just curious why the coverage criteria would be such a headwind? And then I have a follow on.

偉大的。大家好。感謝您的提問。我將從液晶顯示器開始。這裡只有一對夫婦。 Dave，今天使用 Cyclo G6 的中度患者和重度患者的組合是怎麼樣的？我想在過去，你曾談到中等對 G6 來說是一個非常大的機會，因為它可能不超過今天交易量的 25%。所以我猜你們的內容大部分都是難治性患者。我只是好奇為什麼覆蓋標準會如此不利？然後我有一個後續。

Yeah, hi, Tom, thanks for the question. Yeah. So the very late stage patients in -- the criteria calls for, for example, a very limited visual potential and pain among the list of various things. They also call for having had a prior trabeculectomy or tube shunt procedure. So these are all restrictions that would eliminate a lot of the later stage procedures as well. So we think it's probably in the 25% range that would qualify under this strict criteria in about 75% of our procedures in advanced stage patients, but in front of these kinds of criteria.

是的，嗨，湯姆，謝謝你的提問。是的。因此，非常晚期的患者——該標準要求，例如，視力潛力非常有限，並且在一系列的事情中存在疼痛。他們也要求事先進行小梁切除術或管分流手術。因此，這些限制也將消除許多後期程序。因此，我們認為，在我們對晚期患者進行的大約 75% 的手術中，可能有 25% 的人符合這一嚴格標準，但高於這些標準。

So in the payor places where the MACs are the insurers of the patients, we think it's pretty restrictive. That said, if the clinicians understand the coverage that their patients have, on average, it's going to be two thirds that maintain coverage. And so we think it's important to work with clinicians. So that they understand what their coverage of their patients is. And if they aren't in the practice now of knowing their coverage, it might be something they might want to take-up.

因此，在支付方，MAC 是病患的保險公司，我們認為這是相當嚴格的。也就是說，如果臨床醫生了解患者的保險範圍，平均而言，將有三分之二的人維持保險範圍。因此，我們認為與臨床醫生合作很重要。以便他們了解他們對患者的承保範圍。如果他們現在不知道自己的覆蓋範圍，那麼他們可能會想要接受這一點。

That makes sense. And then with LCDs, just regarding the timing of the 8-K, the proposed LCDs obviously came out starting in June and CDC wasn't even determined to be covered at that time. So why is it now expected to be a 2023 headwind or issue? And maybe why wasn't that the case or the thought -- I guess it was four or five months ago?

這就說得通了。然後是 LCD，就 8-K 的時間而言，擬議的 LCD 顯然是從 6 月開始推出的，當時 CDC 甚至還沒有確定要涵蓋其中。那麼為什麼現在預計它會成為 2023 年的逆風或問題呢？也許為什麼情況或想法不是這樣——我猜那是四、五個月前的事了？

Yeah. So the proposed LCDs came out in the June timeframe. We responded with an appeal, and I described some of the clinical evidence that we submitted and a number of other arguments to retain coverage. We were somewhat successful in that in the original LCDs, they had classified all of cyclophotocoagulation as investigational. And now that there's a coverage, but with a lot of restrictions associated with them. And we think erroneously assumptions went into creating that lift.

是的。因此，建議的液晶顯示器在六月的時間範圍內問世。我們以上訴作為回應，我描述了我們提交的一些臨床證據以及保留承保範圍的其他一些論點。我們在最初的 LCD 中取得了一定的成功，他們將所有的睫狀體光凝術都歸類為研究性的。現在有了保險，但也有很多相關的限制。我們認為創造這種升力的假設是錯誤的。

This happened two years ago. One of the MACs had proposed it be -- cyclophotocoagulation be investigational during the proposed period. We sent back responses and were successful and there was no change, no mention in the finals. So in the time frame when this year's LCDs were submitted as proposed, and we put it in our responses, we deemed that it was not likely that there would be some incremental restrictions that came to us.

這件事發生在兩年前。其中一位 MAC 提議在提議的時間內對睫狀體光凝術進行研究。我們發回了回應並且成功了，沒有任何變化，決賽中也沒有提及。因此，在今年的液晶顯示器按提議提交的時間範圍內，我們將其納入我們的答覆中，我們認為我們不太可能出現一些增量限制。

So we didn't put out an 8-K at the time. And frankly, a lot of the clinicians are unaware of that whole sequence of events and are just now learning that the new LCD final determinations are going to affect and -- it's almost real-time here and how they're considering it and learning about it, considering it displaying some outrage, but then trying to figure out, okay, what am I going to do going forward?

所以我們當時沒有推出8-K。坦白說，許多臨床醫生並不知道整個事件的順序，並且剛剛了解到新的 LCD 最終決定將產生影響，並且 - 這裡幾乎是實時的，以及他們如何考慮它並了解考慮到它表現出一些憤怒，但隨後試圖弄清楚，好吧，我接下來要做什麼？

So for us, in cyclophotocoagulation, it really didn't become an issue until the actual determination came out. Now that the actual determination has come out, and we have a significant restriction, we think there's two potential short-term impacts that have a wide range of variability here for Q4.

所以對我們來說，在睫狀體光凝術中，直到實際的決定出來之前，這實際上並沒有成為一個問題。現在實際的決定已經出來，並且我們有一個重大的限制，我們認為有兩個潛在的短期影響，對第四季度有很大的可變性。

Number one, I think in a lot of the areas where MAC coverage is restricted, that clinicians will reconsider or extend the consideration whether to adopt and buy a new system and probes or not. And we think it's likely that they'll take their time. And so those potential purchases will be deferred out of this year for sure.

第一，我認為在許多 MAC 覆蓋範圍受到限制的地區，臨床醫生將重新考慮或擴大考慮是否採用和購買新的系統和探頭。我們認為他們很可能會慢慢來。因此，這些潛在的採購肯定會推遲到今年。

Second is that in those areas where the decision is well, if I've got only partial coverage, I'm not going to offer it to patients. So I'm going to use up my inventory, I'm not going to be ordering to replenish. So I will significantly reduce the orders from -- for the remainder of the year as I use up the probes I have before restrictions come in place, and I stop offering them.

其次，在那些決策良好的領域，如果我只有部分承保，我就不會提供給病人。所以我會用完我的庫存，我不會訂購來補充。因此，我將在今年剩餘時間內大幅減少訂單，因為我會在限制實施之前用完現有的探測器，並停止提供它們。

And we've had conversations with a number of clinicians. And frankly, they're all across the board on what they may or may not do going forward. So we, rather than try to put a very broad range of potential outcomes in the quarter, we just withheld the guidance -- suspended the guidance.

我們與許多臨床醫生進行了交談。坦白說，他們對未來可能做什麼或不做什麼都有全面的看法。因此，我們沒有試圖在本季度提供非常廣泛的潛在結果，而是只是保留了指導——暫停了指導。

Got it. That's great color. And then last question, just pivoting to retina. Modest upside in the quarter relative to our estimates and sequential growth was very strong. I guess, Dave, can you talk about how you're executing in that business and you're now lapping, I think, some tougher comps. So what do you believe is a sustainable growth rate for that segment as we sit here today? Thanks.

知道了。那顏色真棒。最後一個問題，轉向視網膜。相對於我們的預期，本季略有上升，環比成長非常強勁。我想，戴夫，你能談談你在這項業務中的執行情況嗎？我認為，你現在正在完成一些更艱難的比賽。那麼，當我們今天坐在這裡時，您認為該細分市場的可持續成長率是多少？謝謝。

Sure. The retina business is strong. The weakness in macro environmental considerations that really proliferated across the start of the year demonstrated to us that clinicians were deferring -- were not canceling, but deferring their decisions to buy. And I think part of that might be -- the third quarter performance might be deferrals from the second quarter that came in in the third quarter. And so we feel like maybe we're passing that uncertainty period.

當然。視網膜業務強勁。宏觀環境因素的疲軟在今年年初確實激增，這向我們表明臨床醫生正在推遲——不是取消，而是推遲他們的購買決定。我認為部分原因可能是——第三季的業績可能是從第二季推遲到第三季的。所以我們覺得我們可能正在度過那個不確定時期。

We also introduced our new Iridex PASCAL platform, and that's been very well received. And so we're seeing people having the opportunity to evaluate that and decide to purchase. So we think the capital equipment side is solid in the US. Internationally, I can't claim that we've seen that kind of -- I'll call it recovery of the purchase mentality, and we've got the inventory swings that occur in distributors.

我們還推出了新的 Iridex PASCAL 平台，並且受到了廣泛好評。因此，我們看到人們有機會評估並決定購買。因此，我們認為美國的資本設備方面是穩固的。在國際上，我不能說我們已經看到了這種情況——我稱之為購買心態的恢復，而且我們已經看到分銷商發生的庫存波動。

So we can have a higher quarter, and then the next quarter lower, then the next quarter higher. There's a little bit of increased volatility as distributor inventory varies from quarter to quarter as well. So all in all, we think that the glaucoma -- sorry, the retina business is, strong and we can look forward to solid growth in the future. It's a mature segment of the industry, the approximate long-term growth rate is in the mid to lower single digits. We think we can grow at that rate or better.

因此，我們可以有一個更高的季度，然後下一個季度更低，然後下一個季度更高。由於分銷商庫存每季都有所不同，波動性也有所增加。總而言之，我們認為青光眼——抱歉，視網膜業務很強勁，我們可以期待未來的穩健成長。這是該行業的成熟部分，長期成長率大致在中低個位數。我們認為我們可以以這個速度或更好的速度成長。

And I think we will continue to see a little volatility quarter to quarter and it's the moving average that's probably more indicative of how the business is doing. But we're quite comfortable and confident in the retina side of the business.

我認為我們將繼續看到季度與季度之間的小幅波動，而移動平均線可能更能反映業務的表現。但我們對視網膜方面的業務非常滿意和有信心。

Got it. Thanks, Dave, and thanks for all the color.

知道了。謝謝戴夫，謝謝所有的顏色。

Thanks, Tom.

謝謝，湯姆。

Scott Henry, Roth Capital.

史考特·亨利，羅斯資本。

Thank you. Good afternoon. Dave, I just wanted you -- did I hear you correct with regards to the retina business, when we think about organic growth there, did I hear you correct, mid-single digits is what you would be shooting for or the categories that -- I just want to make sure I got that.

謝謝。午安.戴夫，我只是想要你- 關於視網膜業務，當我們考慮那裡的有機增長時，我聽到你說得對嗎？我聽到你說得對嗎，中個位數就是你要追求的目標或類別 - - 我只是想確保我明白了。

Well, we think the long term -- in that space, the long term is in that range. So it's mature segment. There is replacement cycle and there's expansion at least domestically, there's replacement cycle and there's expansion as a group practice or as a university in a metropolitan area, open satellite facilities in the suburbs, they want the same equipment. And so that's the nature of that market.

嗯，我們認為從長遠來看，在這個領域，長期是在這個範圍內。所以這是成熟的部分。有更換週期，至少在國內有擴張，有更換週期，有作為團體實踐或大都會區的大學、在郊區開放衛星設施的擴張，他們想要相同的設備。這就是該市場的本質。

At this stage, well, we feel like we have the leading technologies. There's not a new cycle being created to replace older equipment because of extraordinary new capabilities. We're in the lead for replacement. And we actually think we can look forward to a replacement cycle because there are so many greater than five years old and even in a lot of PASCAL systems that are in the end of service period where that system breaks, it simply can't be repaired.

在這個階段，我們感覺我們擁有領先的技術。由於非凡的新功能，並沒有創建新的周期來取代舊設備。我們在更換方面處於領先地位。事實上，我們認為我們可以期待一個更換週期，因為有許多超過五年的 PASCAL 系統，甚至在許多處於服務期結束時系統損壞的 PASCAL 系統中，它根本無法修復。

So we think that we can have some opportunities for growth above trend, and if we get a more conducive capital equipment environment that we could see higher growth than that. But we do think that there's still going to be volatility quarter to quarter. And one is particularly strong, as we for example, saw last year's third quarter, the comparisons and the subsequents might be on the weaker side. So the long term trend is up and the short term book moving averages are up in that mid-single digits or better range.

因此，我們認為我們可以有一些高於趨勢的成長機會，如果我們獲得更有利的資本設備環境，我們可以看到比這更高的成長。但我們確實認為季度與季度之間仍然會出現波動。其中一個特別強，例如我們看到去年第三季度，比較和隨後的情況可能會很弱。因此，長期趨勢是上升的，而短期帳面移動平均線則在中個位數或更好的範圍內上升。

Okay. And then with the other line, it declined sequentially from 2Q to 3Q, that kind of $1.9 million number, do you think where -- do you think that's the base or should we expect to decline more? Just trying to get a sense of where the bottom is for that category. I know there's some things that went away and they'll annualize, but just trying to understand what the base level is.

好的。然後，另一條線從第二季到第三季連續下降，即 190 萬美元的數字，您認為這是基礎還是我們應該預期會下降更多？只是想了解該類別的底部在哪裡。我知道有些事情會消失，它們會按年計算，但只是想了解基本水平是什麼。

Yeah. The two drivers of volatility in that number are the change and elimination of a long royalty contract that we had, the patent expired. And so the contract expired, and that was about 500,000 a quarter. And that's why the comparison to last year was a dip of about 500,000. Also in that other category is service revenue. So we have a strong service business where most of it is depot service. They ship a system back to us, we repair it, and ship it back and we sell extended warranty contracts. So we're booking revenue and accruing it quarterly for those extended service warranty contracts.

是的。這個數字波動的兩個驅動因素是我們擁有的長期特許權使用費合約的變更和取消以及專利到期。這樣合約就到期了，一個季度大概是50萬。這就是為什麼與去年相比下降了約 50 萬。另一個類別中還有服務收入。因此，我們擁有強大的服務業務，其中大部分是倉庫服務。他們將系統運回給我們，我們進行維修，然後運回，然後我們出售延長保固合約。因此，我們會為這些延長的服務保固合約記錄收入並按季度累計。

And then we're also doing individual service on a non-functioning system, as well as preventive maintenance. So there are regular preventive maintenance cycles in certain states are stricter than others, but we have a steady flow of systems that need to be checked, calibrated, and recertified and sent back. So that business goes up and down and that can vary by 100,000 or more in any one quarter. So that can contribute to that number.

然後我們也對無法運作的系統進行單獨服務以及預防性維護。因此，某些州的定期預防性維護週期比其他州更嚴格，但我們有穩定的系統需要檢查、校準、重新認證和發回。因此，業務量會起起落落，任何一個季度的變化都可能達到 100,000 甚至更多。所以這可以為這個數字做出貢獻。

Okay. And then on the G6 business, I'm not going to ask you for guidance. I know you're not going to provide that. But when you think about Q4, which I guess we're about halfway through, what should we think about from that perspective? I mean, has systems sold, has it just kind of fallen apart like how do we -- just trying to get a sense of, at least in the next months, what kind of reaction you initially saw?

好的。然後在 G6 業務上，我不會向你尋求指導。我知道你不會提供這個。但是，當你想到第四季時，我想我們已經完成了一半，從這個角度我們應該考慮什麼？我的意思是，系統是否已售出，是否像我們一樣崩潰了——至少在接下來的幾個月裡，您最初看到了什麼樣的反應？

Well, I mean, frankly, so are we. It's all across the board and you feel like a play-by-play announcer because you have one conversation with someone who is from a state where there is no change to coverage. What's the issue here? And then others that just fear this is very restrictive that it could extend to additional payors and are very seriously considering eliminating or at least very significantly restricting their offering of CPC. And those are the factors that make it very difficult.

嗯，我的意思是，坦白說，我們也是。一切都是全面的，你感覺自己像個實況播音員，因為你與來自報道沒有變化的州的人進行了一次對話。這裡有什麼問題？然後其他人只是擔心這是非常嚴格的，它可能會擴展到其他付款人，並且正在非常認真地考慮消除或至少非常顯著地限制他們提供的 CPC。這些都是使其變得非常困難的因素。

And so as much as we tried to really put together a scenarios and identify a range, it's a little bit difficult here. I mean, this news is two weeks old, so. That's the problem with trying to do guidance. And clearly, people have said, I got to wait, let's see what happens, and in terms of system purchases and adoption, if a significant chunk of their intended procedure volume isn't going to be available because it's restricted on reimbursement.

因此，儘管我們試圖真正組合一個場景並確定一個範圍，但這裡有點困難。我的意思是，這個消息已經有兩週了，所以。這就是嘗試進行指導的問題。顯然，人們已經說過，我必須等待，讓我們看看會發生什麼，以及在系統購買和採用方面，如果他們預期的程序量中有很大一部分因為報銷限製而無法使用。

So we will obviously stay very focused on it. And as we can develop a picture, we'll take a look at when it's appropriate to reinstate guidance.

所以我們顯然會非常關注它。當我們可以製定一個藍圖時，我們將研究何時適合恢復指導。

Okay. And I'm going to ask you another question, you may not answer, but you might. If I think about your prior guidance before everything happened with G6, at least in my model, the implication would have been that retina would have been strong in Q4, sequentially stronger in Q4 than Q3, even with the numbers that came in this quarter. Should we still -- I mean is that a reasonable assumption or retina -- is it a seasonably strong Q4 typically? Or I'm just trying to get a sense of how we can take some of the variability out of the model.

好的。我要問你另一個問題，你可能不會回答，但你可能會回答。如果我在G6 發生所有事情之前考慮一下您之前的指導，至少在我的模型中，這意味著視網膜在第四季度會很強大，然後第四季度比第三季度更強，即使是本季度的數據也是如此。我們是否仍然應該——我的意思是這是一個合理的假設或視網膜——第四季度通常是季節性強勁的嗎？或者我只是想了解如何從模型中消除一些可變性。

Yes, without guiding in the fourth quarter, it is the strongest quarter of the year typically. It is above what usually is the second strongest quarter, which is second quarter. I mean, this year's second quarter, we experienced some weakness and every year is a little bit different. But if you look back historically, the fourth quarter is the strongest in it -- I actually don't remember the percentage difference between the weaker and the stronger, but it is stronger.

是的，如果沒有第四季度的指導，它通常是一年中最強勁的季度。它高於通常第二強勁的季度，即第二季度。我的意思是，今年第二季度，我們經歷了一些疲軟，而且每年都有點不同。但如果你回顧歷史，第四季是最強的——我實際上不記得弱者和強者之間的百分比差異，但它更強。

So we think that dynamic is going to be consistent this year. But I know we're only halfway through and capital equipment happens at the end of the quarter. It's the typical pattern where most of the ordering happens later in the year.

因此，我們認為今年的動態將保持一致。但我知道我們才完成一半，資本設備將在本季末到位。這是典型的模式，大部分訂購發生在今年稍後。

Okay, fair enough. Final question. With regards to the appeals process, what would be our next data point?

好吧，很公平。最後一個問題。關於上訴流程，我們的下一個數據點是什麼？

Well, as I said in the comments, we submitted an appeal on the grounds of a misinterpretation of the actual study that they quoted to set the definition of the criteria. And that's in the hands of the various MAC administrators. And there is no -- to find schedules that they must act under and respond under. So it's difficult to know whether they will respond immediately. That's what we seek. We think it's compelling that they do. It's very unusual.

好吧，正如我在評論中所說，我們以對他們引用的實際研究的誤解為由提出了上訴，以建立標準的定義。這掌握在各個 MAC 管理員的手中。而且沒有找到他們必須採取行動和做出反應的時間表。因此很難知道他們是否會立即做出回應。這就是我們所尋求的。我們認為他們這樣做是令人信服的。這很不尋常。

I can't say I've seen it in any other types of situations where the specific paper that you quote, you change the criteria that was written in that paper. And it just seems highly unusual to us and to everyone that we've discussed this with, and seems like an error in interpretation that should be corrected, and we hope they see it that way.

我不能說我在任何其他類型的情況下都見過這種情況，即您引用的特定論文改變了該論文中寫入的標準。對於我們以及與我們討論過這個問題的每個人來說，這似乎都是非常不尋常的，並且似乎是一個應該糾正的解釋錯誤，我們希望他們也這麼認為。

Okay. All right. Thank you, Dave, for taking all the questions.

好的。好的。戴夫，謝謝你提出所有問題。

Thanks, Scott.

謝謝，斯科特。

Thank you. I would now like to turn the call back over to Dave Bruce for any closing remarks.

謝謝。我現在想將電話轉回戴夫·布魯斯（Dave Bruce），請其發表結束語。

Thank you, and thank you all for attending. I know it's a bit of a turbulent time. There was a lot of information that came our way, and we tried to share with you, and we'll stay focused on managing through this situation and look forward to updating you in the future. Thank you.

謝謝大家，也謝謝大家的出席。我知道這是一個有點動盪的時期。我們收到了很多訊息，我們試圖與您分享，我們將繼續專注於應對這種情況，並期待將來為您提供最新資訊。謝謝。

Thank you. This concludes today's conference call. Thank you for your participation. You may now disconnect.

謝謝。今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。