IRIDEX Corp (IRIX) 2022 Q4 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Fourth Quarter 2022 IRIDEX Earnings Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded.

美好的一天，謝謝你的支持。歡迎來到 IRIDEX 2022 年第四季度收益電話會議。 （操作員說明）請注意，今天的會議正在錄製中。

I would now like to hand the conference over to your speaker today, Trip Taylor, Investor Relations.

我現在想把會議交給今天的演講者，投資者關係部的 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.

謝謝大家，也感謝大家參加今天的電話會議。加入我的是首席執行官大衛·布魯斯 (David Bruce)；和臨時首席財務官 Fuad Ahmad。

Earlier today, IRIDEX released financial results for the quarter ended December 31, 2022. A copy of the press release is available on the company's website.

今天早些時候，IRIDEX 發布了截至 2022 年 12 月 31 日的季度財務業績。新聞稿的副本可在公司網站上獲取。

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 the federal securities laws, which are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. Any statements made during this call are not statements of historical fact, including, but not limited to, statements concerning our strategic goals and priorities, product development matters, sales trends and the markets in which we operate. 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. For a discussion of the risks and uncertainties associated with our business, please see our most recent Form 10-K and Form 10-Q filed with the SEC. IRIDEX disclaims any intention or obligation, except as required by law, to update or revise financial projections or forward-looking statements whether because of new information, future events or otherwise. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, March 9, 2023.

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《私人證券訴訟改革法》的安全港條款作出的1995 年。在本次電話會議中所做的任何陳述都不是歷史事實的陳述，包括但不限於關於我們的戰略目標和優先事項、產品開發事項、銷售趨勢和我們經營的市場的陳述。所有前瞻性陳述均基於我們當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存在重大差異。因此，您不應依賴這些陳述。有關與我們業務相關的風險和不確定性的討論，請參閱我們最近向美國證券交易委員會提交的 10-K 表格和 10-Q 表格。除法律要求外，IRIDEX 不承擔因新信息、未來事件或其他原因而更新或修改財務預測或前瞻性陳述的任何意圖或義務。此電話會議包含時間敏感信息，僅截至 2023 年 3 月 9 日今天的現場直播準確無誤。

And with that, I'll turn the call over to Dave.

有了這個，我會把電話轉給戴夫。

Thank you, Trip. Good afternoon, and thank you all for joining us. Today, I'll provide updates on our recent business progress and discuss our 2023 outlook, then Fuad will provide details of the 2022 fourth quarter and full year financial results. Then we'll open the call for questions.

謝謝你，旅行。下午好，感謝大家加入我們。今天，我將提供我們最近業務進展的最新情況並討論我們的 2023 年展望，然後 Fuad 將提供 2022 年第四季度和全年財務業績的詳細信息。然後我們將打開問題電話。

As we preannounced on January 10, for the full year 2022, we generated revenue in line with our guidance of $57 million, representing an increase of 6% compared to 2021. Beyond the financial results, 2022 was highly productive for IRIDEX. We achieved regulatory clearance to market and sell the Cyclo G6 platform in China, introduced suite management software for the Cyclo G6, maintained a strong presence at glaucoma society meetings and published a two-part expert consensus to raise awareness of the clinical benefits of MicroPulse PLT.

正如我們在 1 月 10 日預先宣布的那樣，在 2022 年全年，我們的收入達到了 5700 萬美元，與 2021 年相比增長了 6%。除了財務業績外，2022 年對 IRIDEX 來說是高產的。我們獲得了在中國上市和銷售 Cyclo G6 平台的監管許可，為 Cyclo G6 推出了套件管理軟件，在青光眼學會會議上保持了強大的影響力，並發布了一份由兩部分組成的專家共識，以提高人們對 MicroPulse PLT 臨床益處的認識.

Despite a soft first half to the year from COVID and international challenges of dollar strength and inflation, these activities meaningfully advanced G6 adoption and G6 probe growth in the second half of 2022. And we continue to experience solid growth this quarter to date. Additionally, we received FDA clearance for the next-generation IRIDEX PASCAL scanning laser platform in November and are today announcing clearance of the IRIDEX 532 and 577 a single-spot laser platform received in February. We've already begun the U.S. launch for PASCAL and will begin the single-spot platform launch at midyear. We expect all these achievements to build momentum for our business in 2023.

儘管 COVID 以及美元走強和通貨膨脹等國際挑戰導致今年上半年疲軟，但這些活動有意義地推動了 G6 的採用和 G6 探測在 2022 年下半年的增長。本季度迄今為止，我們繼續實現穩健增長。此外，我們於 11 月獲得了 FDA 對下一代 IRIDEX PASCAL 掃描激光平台的許可，今天宣布 IRIDEX 532 和 577 單點激光平台於 2 月獲得許可。我們已經開始在美國推出 PASCAL，並將在年中開始推出單點平台。我們希望所有這些成就都能在 2023 年為我們的業務注入動力。

Turning to the fourth quarter. Revenue totaled $15.2 million, in line with the prior year period, driven by growth from the Cyclo G6 product family, U.S. retina sales and other revenue being offset by declines in some retina products internationally. We also reduced our cash used in operations by half to under $1 million in the quarter.

轉到第四季度。收入總計為 1520 萬美元，與上年同期持平，這主要得益於 Cyclo G6 產品系列、美國視網膜銷售和其他收入的增長，這些收入被國際上一些視網膜產品的下滑所抵消。我們還將本季度用於運營的現金減少了一半，降至 100 萬美元以下。

Looking closer at the glaucoma business. Cyclo G6 revenue increased by 9% year-over-year to $4.2 million. In the quarter, we achieved record international G6 probe unit sales and sold a worldwide total of 16,400 probes, representing growth of 8% compared to the fourth quarter of 2021. G6 system sales decreased slightly compared to the prior fourth quarter but results were at the midpoint of our overall annual guidance.

仔細觀察青光眼業務。 Cyclo G6 收入同比增長 9% 至 420 萬美元。本季度，我們實現了創紀錄的國際 G6 探頭單位銷量，全球共售出 16,400 個探頭，與 2021 年第四季度相比增長了 8%。G6 系統銷量與上一季度相比略有下降，但業績與我們整體年度指導的中點。

We see significant opportunities to increase G6 probe volume and adoption by staying focused on 4 key initiatives. First, continuing our advanced physician education, keying on proper dosing and broader patient selection criteria; second, targeting comprehensive ophthalmologists who see the most moderate stage pre-incisional patients; third, adding users at surgery centers that already have G6 systems; and fourth, expanding clinical evidence supporting adoption of MicroPulse PLT.

通過專注於 4 個關鍵舉措，我們看到了增加 G6 探測量和採用率的重要機會。首先，繼續我們的高級醫師教育，重點是適當的劑量和更廣泛的患者選擇標準；第二，針對最中等階段切開前患者的綜合眼科醫生；第三，在已經擁有 G6 系統的手術中心增加用戶；第四，擴大支持採用 MicroPulse PLT 的臨床證據。

The main components of our education strategy are peer-to-peer discussions on dosing recommendations based on clinical study evidence and sharing updates on MicroPulse PLT use on a broader patient population, in particular, earlier in the glaucoma treatment continuum.

我們教育策略的主要組成部分是基於臨床研究證據的劑量建議的同行討論，以及在更廣泛的患者群體中分享 MicroPulse PLT 使用的更新，特別是在青光眼治療連續體的早期。

At the AGS just completed in Austin, Texas, Dr. Syril Dorairaj presented his early results from a prospective randomized dose escalation study, demonstrating 31% to 44% intraocular pressure reductions, with greater treatment efficacy resulting from slower probe sweep speeds while still providing the same consistently excellent safety profile. It's becoming clear that the key to consistently high IOP reduction is proper sweep speeds and that this technique maintains the very benign safety profile.

在德克薩斯州奧斯汀剛剛結束的 AGS 上，Syril Dorairaj 博士展示了他一項前瞻性隨機劑量遞增研究的早期結果，表明眼內壓降低了 31% 至 44%，由於較慢的探頭掃描速度，治療效果更好，同時仍然提供同樣始終如一的出色安全性。越來越清楚的是，持續降低 IOP 的關鍵是適當的掃描速度，並且該技術保持非常良好的安全性。

To facilitate excellent treatment technique, we launched and promoted our suite management systems software upgrade. This software helps guide users to select and execute proper sweep speeds during treatments according to best practices developed by our clinical consensus panel. It's working. Users are reporting this helps reduce variability of technique and helps them deliver more consistently strong results to meet their outcomes expectations.

為了促進卓越的治療技術，我們推出並推廣了套房管理系統軟件升級。該軟件有助於指導用戶根據我們的臨床共識小組制定的最佳實踐在治療期間選擇和執行適當的掃描速度。它的工作。用戶報告這有助於減少技術的可變性，並幫助他們提供更一致的強大結果以滿足他們的結果期望。

The next component of our growth strategy is to increase awareness of the benefits of MicroPulse PLT earlier in the glaucoma treatment continuum as an effective pre-incisional intervention. About 50% of the 2022 proctor cases supported by our field team were pre-incisional patients treated by both glaucoma specialists and increasingly with targeted comprehensive ophthalmologists who typically diagnose and treat patients with earlier stages of glaucoma. This targeted cohort of clinicians and patients has the potential to meaningfully expand G6 penetration in the continuum of glaucoma care.

我們增長戰略的下一個組成部分是提高人們對青光眼治療連續體早期 MicroPulse PLT 作為一種有效的切口前干預的好處的認識。在我們的現場團隊支持的 2022 名監考案例中，約有 50% 是由青光眼專家治療的切開前患者，並且越來越多地由通常診斷和治療早期青光眼患者的有針對性的綜合眼科醫生治療。這個針對臨床醫生和患者的隊列有可能有意義地擴大 G6 在青光眼護理連續體中的滲透。

Internationally, we initiated the G6 launch in China in the second half of last year alongside our distribution partners with 15 key opinion leader pilot sites and approximately 120 patients. While China's COVID policy lockdowns in 2022 slowed the initial adoption ramp, patient flow is increasing again, and we believe this can drive growth in 2023. In addition, last year, we increased our international commercial team to provide more expert resources in support of our distribution partners and customers.

在國際上，我們於去年下半年與我們的分銷合作夥伴一起在中國啟動了 G6 的發布，該合作夥伴擁有 15 個關鍵意見領袖試點站點和大約 120 名患者。雖然中國 2022 年的 COVID 政策封鎖減緩了最初的採用速度，但患者流量再次增加，我們相信這可以推動 2023 年的增長。此外，去年，我們增加了國際商業團隊，以提供更多的專家資源來支持我們的分銷合作夥伴和客戶。

And finally, we have great confidence we have the right probe design and clinical proof of efficacious and very safe dosing guidance executed through user software supporting proper treatment protocols. We believe we have a stable procedure ready to design and launch a larger-scale multicenter prospective trial. The study will target demonstrating the safety and substantial effectiveness of MicroPulse DLT for moderate-stage glaucoma patients. Active discussions on proper study design and protocols are underway with key opinion leaders. Once we've determined the optimal protocol for the study, we can begin to recruit participating centers. We are making this investment in 2023 and hope to begin enrolling patients in the study by year-end.

最後，我們非常有信心，我們擁有正確的探頭設計和有效且非常安全的劑量指導的臨床證據，通過支持適當治療方案的用戶軟件執行。我們相信我們有一個穩定的程序可以設計和啟動更大規模的多中心前瞻性試驗。該研究的目標是證明 MicroPulse DLT 對中度青光眼患者的安全性和實質性有效性。正在與主要意見領袖就適當的研究設計和協議進行積極討論。一旦我們確定了研究的最佳方案，我們就可以開始招募參與中心。我們將在 2023 年進行這項投資，並希望在年底前開始招募患者參與研究。

We have high conviction in our ability to grow the glaucoma business over the long term. We're excited to provide this on a larger scale and ultimately capture a substantial role in the continuum of care for glaucoma sufferers. Altogether, as we look ahead to 2023, we expect to increase the growth rate of our glaucoma business. We expect probe revenue growth of 9% to 12% compared to 2022. We expect to sell 65,000 to 67,000 probes and grow the installed base by 225 to 250 glaucoma laser systems.

我們堅信我們有能力長期發展青光眼業務。我們很高興能夠更大規模地提供這項服務，並最終在青光眼患者的連續護理中發揮重要作用。總而言之，展望 2023 年，我們預計將提高青光眼業務的增長率。與 2022 年相比，我們預計探頭收入將增長 9% 至 12%。我們預計將銷售 65,000 至 67,000 個探頭，並將安裝基數增加 225 至 250 個青光眼激光系統。

Now turning to our retina business. For the fiscal year 2022, product revenue increased by 2% to $31.7 million compared to 2021 despite some softness in international markets leading to a decrease of 11% in the fourth quarter compared to the prior year period.

現在轉向我們的視網膜業務。在 2022 財年，產品收入與 2021 年相比增長 2% 至 3170 萬美元，儘管國際市場有些疲軟導致第四季度與去年同期相比下降 11%。

On our last call, we announced we had received U.S. FDA clearance for our new PASCAL laser scanning platform. We began shipments to U.S. customers in the fourth quarter and we anticipate regulatory filings and approvals internationally throughout 2023. The new IRIDEX PASCAL platform offers the ultimate combination of the leading pattern scanning engine, end point management technology, pattern scanning laser trabeculoplasty, which is a glaucoma treatment for early-stage patients. And now with IRIDEX' proven MicroPulse technology, it provides physicians with expanded treatment capabilities in an integrated system with 1/2 the footprint of the prior platform.

在上次通話中，我們宣布我們的新 PASCAL 激光掃描平台已獲得美國 FDA 批准。我們在第四季度開始向美國客戶發貨，我們預計整個 2023 年將在國際上進行監管備案和批准。新的 IRIDEX PASCAL 平台提供了領先的模式掃描引擎、終點管理技術、模式掃描激光小梁成形術的終極組合，這是一種早期青光眼患者的治療。現在，憑藉 IRIDEX 久經考驗的 MicroPulse 技術，它在集成系統中為醫生提供了擴展的治療能力，其占地面積僅為先前平台的 1/2。

And today, we're pleased to announce that we received FDA clearance in February for our single-spot platform consisting of the IRIDEX 532 green laser and the IRIDEX 577 yellow laser. We'll share more details as we launch them in the U.S. around midyear.

今天，我們很高興地宣布，我們的單點平台由 IRIDEX 532 綠色激光器和 IRIDEX 577 黃色激光器組成，已於 2 月獲得 FDA 批准。我們將在年中左右在美國推出它們時分享更多細節。

We believe both updated laser platforms can drive replacement cycles for the significant installed base of older equipment reaching end of life. The improvements we've made not only include technology updates that will produce clinical benefits but also provide manufacturing efficiencies that will translate to pricing flexibility for share gains or improved margins. Our investments over the last couple of years have resulted in material improvements to our retina business and is now operating from a significantly stronger competitive position in both product and sales channel potential.

我們相信，這兩種更新的激光平台都可以為大量已達到使用壽命的舊設備安裝基礎推動更換週期。我們所做的改進不僅包括將產生臨床效益的技術更新，而且還提供製造效率，這將轉化為定價靈活性以獲取份額收益或提高利潤率。我們在過去幾年的投資使我們的視網膜業務有了實質性的改善，現在在產品和銷售渠道潛力方面都處於明顯更強大的競爭地位。

Now I'd like to turn the call over to Fuad.

現在我想把電話轉給 Fuad。

Good afternoon, everyone, and thank you for joining us today. I would like to begin by reviewing our financial performance for the fourth quarter and full year fiscal 2022.

大家下午好，感謝您今天加入我們。首先，我想回顧一下我們第四季度和 2022 財年全年的財務業績。

Starting with revenue. Our total revenue for the fourth quarter was $15.2 million, which was in line with the fourth quarter of last year. Our total revenue for 2022 increased by 6% to $57 million compared to $53.9 million in 2021.

從收入開始。我們第四季度的總收入為 1520 萬美元，與去年第四季度持平。與 2021 年的 5390 萬美元相比，我們 2022 年的總收入增長了 6%，達到 5700 萬美元。

Moving on to product revenues. The overall revenue from the Cyclo G6 product family in the fourth quarter was $4.2 million, up 9% compared to the same period in 2021. We are pleased to report that we sold a quarterly record 16,400 Cyclo G6 probes in the fourth quarter, an increase of 8% from the prior year period and an increase of 20% quarter-over-quarter. We sold 79 Cyclo G6 systems in the quarter compared to 90 in the prior year period. Total glaucoma product revenue for 2022 was $14.7 million, up 5% from 2021.

轉向產品收入。第四季度 Cyclo G6 產品系列的總收入為 420 萬美元，與 2021 年同期相比增長 9%。我們很高興地報告，我們在第四季度售出了創紀錄的 16,400 個 Cyclo G6 探頭，同比增長同比增長 8%，環比增長 20%。我們在本季度售出了 79 套 Cyclo G6 系統，而去年同期為 90 套。 2022年青光眼產品總收入為1470萬美元，比2021年增長5%。

Our retina product revenue in the fourth quarter was $8.1 million, a decrease of 11% compared to the prior year period. For the full year 2022, our retina product revenue was $31.7 million, up 2% compared to 2021. Other revenue, which includes royalties, services and other legacy products increased 26% to $2.9 million in the fourth quarter compared to the same period in 2021. For the full year 2022, other revenue grew 20% to $10.6 million compared to $8.8 million in 2021 on higher service, royalty, top line distribution and legacy product revenue.

我們第四季度的視網膜產品收入為 810 萬美元，比去年同期下降 11%。 2022 年全年，我們的視網膜產品收入為 3170 萬美元，比 2021 年增長 2%。與 2021 年同期相比，第四季度其他收入（包括特許權使用費、服務和其他遺留產品）增長 26% 至 290 萬美元. 對於 2022 年全年，其他收入增長 20% 至 1060 萬美元，而 2021 年為 880 萬美元，原因是服務、特許權使用費、頂線分銷和遺留產品收入增加。

Our gross profit for the fourth quarter of 2022 increased to $6.7 million, up 11% for the same period last year. Gross margin was 43.9% compared to 39.3% in the fourth quarter of 2021 on revenue mix that favored U.S. revenue. Gross profit for the full year was $25.4 million, up 11% from the prior year. Gross margin was 44.5% in 2022 compared to 42.3% gross margin during the same period last year.

我們 2022 年第四季度的毛利潤增至 670 萬美元，比去年同期增長 11%。由於收入組合有利於美國收入，毛利率為 43.9%，而 2021 年第四季度為 39.3%。全年毛利潤為 2540 萬美元，比上年增長 11%。 2022 年毛利率為 44.5%，而去年同期為 42.3%。

Operating expenses for the fourth quarter were $8.1 million compared to $8.4 million in the same period of the prior year. Total operating expenses for 2022 were $32.9 million compared to $30.4 million in 2021.

第四季度的運營費用為 810 萬美元，上年同期為 840 萬美元。 2022 年的總運營費用為 3290 萬美元，而 2021 年為 3040 萬美元。

Our net loss in the fourth quarter was $1.1 million or a net loss of $0.07 per share compared to a net loss of $2.4 million or $0.15 per share for the same period in 2021. For the full year, we recorded a net loss of $7.5 million or $0.47 per share compared to a net loss of $4.2 million or $0.34 per share in 2021.

我們第四季度的淨虧損為 110 萬美元或每股淨虧損 0.07 美元，而 2021 年同期為淨虧損 240 萬美元或每股 0.15 美元。全年淨虧損為 750 萬美元或每股 0.47 美元，而 2021 年淨虧損為 420 萬美元或每股 0.34 美元。

Cash and cash equivalents as of December 31, 2022, totaled $13.9 million. Cash used in the operation was down $900,000 in the fourth quarter, while the total cash reduction in the quarter was only $2 million. The cash reduction during the year of $10 million included approximately $3.5 million increase in inventory and related preorders to mitigate supply chain issues. However, we expect such inventory to substantially unwind over the course of 2023.

截至 2022 年 12 月 31 日，現金和現金等價物總計 1390 萬美元。第四季度該業務使用的現金減少了 90 萬美元，而該季度減少的現金總額僅為 200 萬美元。年內現金減少 1000 萬美元，其中庫存和相關預購訂單增加約 350 萬美元，以緩解供應鏈問題。然而，我們預計此類庫存將在 2023 年期間大幅減少。

Finally, I will now provide our guidance for the full year of fiscal 2023. We anticipate Cyclo G6 probe unit sales of 65,000 to 67,000 which represents a growth of 9% to 12% over the prior year. We expect to expand the Cyclo G6 systems installed base by 225 to 250 units.

最後，我現在將提供我們對 2023 財年全年的指導。我們預計 Cyclo G6 探針的銷量為 65,000 至 67,000，比上一年增長 9% 至 12%。我們預計 Cyclo G6 系統的安裝基數將增加 225 至 250 台。

Total revenue for the year is expected to be $57 million to $59 million. Please note that the full year 2023 total revenue guidance represents a growth of approximately 3% to 6% after adjusting for an approximate $1.5 million reduction of other revenue royalty income resulting from the expiration of licensed patents.

今年的總收入預計為 5700 萬至 5900 萬美元。請注意，在對因許可專利到期而導致的其他收入特許權使用費收入減少約 150 萬美元進行調整後，2023 年全年總收入指引表示增長約 3% 至 6%。

Implicit in our guidance for fiscal 2023 is full recovery from any lingering COVID-19-related pressures. However, currency fluctuations, inflation and supply chain may continue to represent headwinds, albeit manageable. We are confident in our ability to address these issues and continue to execute on our core strategy centered around increasing growth in our glaucoma treatment adoption and rolling out our new retina platform.

我們對 2023 財年的指導意見暗示要從任何揮之不去的與 COVID-19 相關的壓力中完全恢復。然而，貨幣波動、通貨膨脹和供應鏈可能繼續構成不利因素，儘管是可控的。我們相信我們有能力解決這些問題，並繼續執行我們的核心戰略，該戰略以增加青光眼治療採用率的增長和推出我們的新視網膜平台為中心。

I will now turn the call over to the operator for any questions. Operator?

如有任何問題，我現在會將電話轉給接線員。操作員？

(Operator Instructions) Our first question comes from Scott Henry with ROTH Capital.

（操作員說明）我們的第一個問題來自 ROTH Capital 的 Scott Henry。

I just had a couple of questions, largely on the modeling front. First, any thoughts on how we should expect the cadence of the year to go as far as revenues, any guidance? Or should we expect historical trends?

我只是有幾個問題，主要是關於建模方面的問題。首先，關於我們應該如何預期今年的收入節奏有什麼想法，有什麼指導嗎？還是我們應該期待歷史趨勢？

Scott, I think it's shaping up to be more of a typical -- as you know, we're not linear. We typically see strongest in the fourth quarter, some softness in the third quarter. Maybe the second strongest is the second quarter. And from where we sit today, I don't see that changing dramatically.

斯科特，我認為它正在變得更典型——如你所知，我們不是線性的。我們通常會看到第四季度最強勁，第三季度出現一些疲軟。也許第二強的是第二季度。從我們今天所處的位置來看，我認為這種情況不會發生巨大變化。

Okay. And then should we expect operating expenses to be similar in 2023 as in 2022? And also would gross margins be similar? Or might we get a little bit of gross margin expansion? How should we think about that?

好的。那麼我們是否應該期望 2023 年的運營費用與 2022 年相似？毛利率也會相似嗎？或者我們可能會得到一點毛利率擴張？我們應該如何考慮？

I think let me address the gross margin first. I think we should see some expansion of gross margin in 2023 relative to 2022. I think '22 was still in a period in which we had supply chain issues, and we're making payments in advance and sometimes paying a premium for some parts. I think that should subside in 2023. So we should expect some expansion. We're not going to see the expansion that we were hoping for in '22 just given there's still some lingering supply chain issues that we have to deal with. But I think overall, you should see the expansion.

我想讓我先談談毛利率。我認為我們應該看到 2023 年毛利率相對於 2022 年有所擴大。我認為 22 年仍處於我們存在供應鏈問題的時期，我們正在提前付款，有時還會為某些部分支付溢價。我認為這應該會在 2023 年消退。所以我們應該期待一些擴張。我們不會看到我們希望在 22 年實現的擴張，因為我們仍然需要處理一些揮之不去的供應鏈問題。但我認為總的來說，你應該看到擴張。

Also, I think, as you know, a lot of our gross margin depends on both geographic mix as well as the product mix. So with the glaucoma becoming a bigger part of the business, or increasingly a bigger part of the business, we should see naturally gross margins to expand from that as well. So yes, I think the answer to your question, simple answer, is we should see some expansion in '23.

另外，我認為，如你所知，我們的毛利率很大程度上取決於地域組合和產品組合。因此，隨著青光眼在業務中所佔比例越來越大，或者在業務中所佔比例越來越大，我們應該自然而然地看到毛利率也隨之擴大。所以是的，我認為你的問題的答案，簡單的答案是，我們應該在 23 年看到一些擴展。

As for the OpEx, I think for most part, we expect R&D to G&A to kind of remain flat. We do expect sales and marketing, where our clinical spend is, to grow. I think we are going to be investing more dollars into the clinical spend with a view towards growing the adoption rate. And that's been our mantra for the last couple of years, and it's expected to continue.

至於 OpEx，我認為在大多數情況下，我們預計 G&A 的研發將保持平穩。我們確實希望我們的臨床支出所在的銷售和營銷能夠增長。我認為我們將在臨床支出上投入更多資金，以期提高采用率。這是我們過去幾年的口頭禪，預計會繼續下去。

Okay. And the new PASCAL product, should that grow revenues for that line? Or is it more of a substitutive extension?

好的。新的 PASCAL 產品是否會增加該產品線的收入？或者它更像是一種替代性的延伸？

I think there's 2 elements to that. One is it's a more capable system and a smaller footprint. And so a lot of institutions who may not have bought it in the past because of the size now could be attracted, and it's got MicroPulse capability as well, which it never had in the past. So I think that expands the pool.

我認為這有兩個要素。一是它是一個功能更強大的系統和更小的佔地面積。因此，現在可能會吸引許多過去可能因為規模而沒有購買它的機構，並且它還具有 MicroPulse 功能，這是過去從未有過的。所以我認為這擴大了池。

But I think as a new platform, it may be the catalyst for some older sites. We have a significant percentage of PASCAL systems in the installed base that are old and some even past the end of service date, meaning if they wanted to send it in for repairs, essentially, we can't do it. So that can potentially trigger somewhat of a replacement cycle. And so we look for some modest growth because of that piece. And I think internationally, it still remains to be seen because we have to roll out approvals. What's primarily a U.S. phenomenon for the early part and as a percentage for most of the year 2023.

但我認為作為一個新平台，它可能是一些老網站的催化劑。在我們安裝的基礎上，我們有很大一部分 PASCAL 系統是舊的，有些甚至超過了服務結束日期，這意味著如果他們想將其送去維修，基本上，我們做不到。因此，這可能會觸發某種程度的更換週期。因此，我們希望通過這件作品獲得一些適度的增長。而且我認為在國際上，這還有待觀察，因為我們必須推出批准。在 2023 年的大部分時間裡，早期主要是美國現像以及所佔百分比。

Okay. So Dave, a follow-up question on the last question. I mean it sounds like 2023 is going to look a lot like 2022, a little bit more revenues, a little bit more expenses, going to lose between a little more than $5 million in the year, pulling out stock comp. The question is, I mean, you're kind of at a fork in the road, either you grow faster to get profitable or you cut expenses to get profitable. And I mean you're not losing a lot of money, but you're still losing money. So of those two pathways, I mean it sounds like your idea is to invest in the clinic and try to get the top line growing faster. But I just want to give you an opportunity to perhaps shed some light on what direction you'd like to take the company in.

好的。戴夫，關於最後一個問題的後續問題。我的意思是，聽起來 2023 年看起來會很像 2022 年，收入多一點，支出多一點，一年的虧損將超過 500 萬美元，退出股票補償。問題是，我的意思是，你有點處在岔路口，要么你增長得更快以獲利，要么你削減開支以獲利。我的意思是你並沒有損失很多錢，但你仍然在虧錢。所以在這兩種途徑中，我的意思是聽起來你的想法是投資診所並試圖讓收入增長更快。但我只是想給你一個機會，或許可以闡明你希望公司朝哪個方向發展。

Yes. We think that there is a very large growth opportunity in glaucoma. We view the 22 activities as really rebuilding the foundation there and proving out the elements that we believed were in place. And I think by investing in the broader, larger clinical study that we will prove that out further and create a real adoption evidence base that can drive us from, say, early adopters or use at the margin when other things aren't working into the mainstream. And that's just a very large opportunity. So we're focused on that big growth piece.

是的。我們認為青光眼有非常大的增長機會。我們將這 22 項活動視為真正重建那裡的基礎並證明我們認為已經到位的要素。而且我認為，通過投資於更廣泛、更大規模的臨床研究，我們將進一步證明這一點，並創建一個真正的採用證據基礎，可以讓我們遠離早期採用者，或者在其他因素不起作用時在邊緣使用主流。這只是一個非常大的機會。所以我們專注於那個巨大的增長部分。

The decision to maintain the level of investment in sales and marketing and clinical is really driven by that. We do see a tailwind from unwinding the inventory builds and prepaids because we think the supply chain can soften up and get back towards normal in 2023. So we were up $3.5 million in cash usage of '22 because of that. And if we unwind that, that turns into a cash tailwind. So comparable usage of cash with a tailwind of cash coming from the balance sheet puts us still with a substantial amount of cash and the runway to execute that growth trajectory.

保持對銷售和營銷以及臨床的投資水平的決定實際上是受此驅動的。我們確實看到了解除庫存和預付款的順風，因為我們認為供應鏈可以在 2023 年軟化並恢復正常。因此，我們在 22 年的現金使用量增加了 350 萬美元。如果我們解除它，那將變成現金順風。因此，可比較的現金使用和來自資產負債表的現金順風使我們仍然擁有大量現金和執行該增長軌蹟的跑道。

Our next question comes from Tom Stephan with Stifel.

我們的下一個問題來自 Stifel 的 Tom Stephan。

I'll start with the G6 probe growth guidance of 9% to 12%. Dave, can you just talk a bit about the different dynamics at play between the U.S. and OUS? I know in the OUS, there's maybe been some volatility. But just for 2023, how are you thinking about kind of growth between each region?

我將從 9% 到 12% 的 G6 探測增長指導開始。戴夫，你能談談美國和美國之間的不同動態嗎？我知道在 OUS，可能存在一些波動。但就 2023 年而言，您如何看待每個地區之間的增長？

Tom, yes, we do anticipate, I'll say, continued volatility in the international space. And so as much as we're focused on there are specific activities to drive that growth and working with our distribution partners, it can still ebb and flow. And we don't have direct contact to sell into customers, and so we maybe are a little bit more conservative on how much we can grow internationally.

湯姆，是的，我們確實預計，我會說，國際空間將持續動盪。因此，儘管我們專注於推動這種增長並與我們的分銷合作夥伴合作的具體活動，但它仍然可以潮起潮落。而且我們沒有直接聯繫來銷售給客戶，所以我們可能對我們可以在國際上增長多少更加保守。

Domestically, we're starting to see the impacts of renewed confidence, I'll say, or broader confidence given our treatment parameters as well as coupling that with a suite management software methodology to assure that the intended techniques are actually followed through. And you and I have talked about the challenges or opportunities to standardize that treatment. So we think that we can be a little stronger in the U.S. compared to OUS in terms of probe growth. And as I commented, we're starting to see that follow through here, at least first quarter to date. And we're encouraged that we're going to accomplish that.

在國內，我們開始看到恢復信心的影響，我會說，或者更廣泛的信心給定我們的治療參數，並將其與套件管理軟件方法相結合，以確保實際遵循預期的技術。你和我都談到了使這種治療標準化的挑戰或機遇。所以我們認為在探測增長方面，我們在美國可以比 OUS 強一點。正如我評論的那樣，我們開始看到這種情況會持續到這裡，至少是第一季度。我們感到鼓舞的是，我們將要實現這一目標。

Got it. That's helpful. And Dave, if I can push you a bit, just looking at the model, I believe it implies flat utilization year-over-year in 2023. And again, OUS was challenging in '22 as well, so the comp isn't overly difficult on that front. I guess big picture, what gives you confidence you can reaccelerate growth in the glaucoma business more broadly? You gave the 4 key initiatives, which make perfect sense, but I guess what really gets this going again? And maybe what's the timing of when we'll start to see those signs trickle through in the numbers?

知道了。這很有幫助。戴夫，如果我能給你一點壓力，只要看看這個模型，我相信這意味著 2023 年的利用率同比持平。而且，OUS 在 22 年也很有挑戰性，所以這個補償並不過分在這方面很困難。我想從大局來看，是什麼讓您有信心可以更廣泛地重新加速青光眼業務的增長？您提出了 4 項關鍵舉措，這非常有道理，但我想真正讓這一切再次發生的是什麼？也許什麼時候我們會開始看到這些跡像在數字中逐漸出現？

Yes. Thanks for that. As I mentioned, we see the signs that it's working in the sense that when people select the right treatment parameters and then execute those, that they are pleased with the results. And they're substantial. The study that I was referring to that was presented, at least the early results presented at the American Glaucoma Society, 30% and 40% IOP reductions are at the top end of what can be achieved with other technologies. So we're really pleased that we can do that with a non-incisional procedure and get the durability which, when you get those high IOP reductions in 3- to 6-month period, it tends to carry on for durability. So we'll see what the particular study data demonstrates, but we expect that to bear out.

是的。感謝那。正如我提到的，我們看到了它在某種意義上起作用的跡象，即當人們選擇正確的治療參數然後執行這些參數時，他們對結果感到滿意。而且它們很重要。我所指的研究已提交，至少是美國青光眼協會提交的早期結果，30% 和 40% 的 IOP 降低是其他技術所能達到的最高水平。所以我們真的很高興我們可以通過非切口手術做到這一點並獲得耐用性，當您在 3 到 6 個月的時間內獲得高 IOP 降低時，它往往會持續耐用。因此，我們將看到特定研究數據所展示的內容，但我們希望這一點得到證實。

And as you get those kinds of results in the hands of users, they tend to gain confidence and start to select a broader set of patients. And that's what we're really focusing on for 2023. Our sales reps are very focused on targets and taking those targets down that pathway of proctor cases and recognizing the results on a representative sample of their patients. And as you look at the opportunity in the space, there's just a dramatically large number of potential procedures if we can achieve that adoption in the moderate-stage pre-incisional patients.

當您將這些結果交到用戶手中時，他們往往會獲得信心並開始選擇範圍更廣的患者。這就是我們 2023 年真正關注的重點。我們的銷售代表非常關注目標，並將這些目標沿著監考案例的路徑進行，並在他們的患者代表性樣本中識別結果。當你看到這個領域的機會時，如果我們能夠在中期切口前患者中實現這種採用，那麼就會有大量的潛在程序。

I've talked about the analogy with SLT, the early-stage laser glaucoma treatment that's been around for 20 years and is clinically mature and has penetrated about 20% of the mild-stage patients in the U.S., so that's the opportunity we're pursuing in about 2 million moderate stage patients. And it will take time, but if you have efficacy, you have safety and you have a way to demonstrate to clinicians that they can achieve that in their hands, we're very confident that, that will drive adoption.

我已經談到了與 SLT 的類比，SLT 是一種早期激光青光眼治療方法，已經存在 20 年，臨床上已經成熟，並且已經滲透到美國大約 20% 的輕度患者中，所以這就是我們的機會在大約 200 萬中度患者中進行研究。這需要時間，但如果你有療效，你有安全性，並且你有辦法向臨床醫生證明他們可以在他們手中實現這一點，我們非常有信心，這將推動採用。

Now the challenge is what rate and, to a certain extent, that's part of the frustration. But at the same time, medical device adoption is always well considered, I'd say, by the mainstream community, and it takes a little bit longer. But when you get that critical mass, the growth rates go up. And we're not trying to predict where that critical mass point and increasing growth rate occurs. We do our guidance based on what we think we can execute through the team given the current situation. So I know that doesn't identify exactly where that occurs, and it really starts to accelerate, but I think all the pieces are in place to get us there.

現在的挑戰是什麼速度，在某種程度上，這是挫敗感的一部分。但與此同時，我想說，主流社區總是充分考慮醫療設備的採用，而且需要更長的時間。但是當你達到那個臨界質量時，增長率就會上升。而且我們並沒有試圖預測臨界點和增長率的增長點在哪裡。我們根據我們認為在當前情況下我們可以通過團隊執行的內容來提供指導。所以我知道這並不能確定發生的確切位置，而且它確實開始加速，但我認為所有的部分都已準備就緒，可以讓我們到達那裡。

No, that makes perfect sense. And then just to pivot to retina for my last question. There might be some unknowns around the G6 ASPs. But to reach the midpoint of your guidance, I'm arriving at roughly flat retina growth. But you do have a lot of new products coming into the field. So I guess, Fuad, am I thinking about that growth correctly? And then, Dave, can you just talk a bit about kind of what headwinds might be suppressing potential positive growth in the retina business?

不，這是完全有道理的。然後就轉向視網膜來回答我的最後一個問題。 G6 ASP 周圍可能存在一些未知數。但要達到你指導的中點，我要達到大致平坦的視網膜生長。但是您確實有很多新產品進入該領域。所以我想，Fuad，我是否正確地考慮了這種增長？然後，戴夫，你能談談什麼樣的逆風可能會抑制視網膜業務的潛在正增長嗎？

Yes. I mean I think retina, we anticipate the retina to grow, but it's going to generally grow with market, somewhere around 3% to 4%. I think there is opportunity for growth further because of the rollout of new products, especially the GenM on the PASCAL side as well as to roll out the new platform. So I think there is an opportunity there for growth in retina as well. But I think for us, when you think about retina, we think about at least preserving market growth rate, which is at least 3%, could be a little higher.

是的。我的意思是我認為視網膜，我們預計視網膜會增長，但它會隨著市場的增長而增長，大約在 3% 到 4% 左右。我認為，由於新產品的推出，特別是 PASCAL 方面的 GenM 以及新平台的推出，有進一步增長的機會。所以我認為視網膜也有生長的機會。但我認為對我們來說，當你考慮視網膜時，我們考慮至少保持市場增長率，即至少 3%，可能會高一點。

Know that I think on the overall revenue, I think one of the things you should be looking at is that we did, as we mentioned in our prepared remarks as well as in the earnings release itself, that we have about $1.5 million of headwind on some royalty income due to some expiring patents. That will happen over the course of the year. I think it will emerge, it will manifest itself in the second half of next year, so you might want to make an adjustment to your model for that. So you have to subtract that. It comes from other revenue. So if you look at the overall growth rate, I think we're still low to mid-double-digit for glaucoma and about 3% growth on the retina piece, so just kind of as you work through your models.

知道我認為關於總收入，我認為你應該關注的一件事是我們所做的，正如我們在準備好的評論和收益發布本身中提到的那樣，我們有大約 150 萬美元的逆風由於一些即將到期的專利而產生的一些特許權使用費收入。這將在一年中發生。我認為它會出現，它會在明年下半年顯現出來，所以你可能想為此調整你的模型。所以你必須減去它。它來自其他收入。因此，如果你看一下整體增長率，我認為青光眼的增長率仍然處於低至中兩位數，視網膜部分的增長率約為 3%，所以就像你研究模型一樣。

And then I think the last question you asked is the headwinds. I think there's kind of uncertainty. We had headwinds for a stronger dollar for most of fiscal '22, and that impacted the OUS sales, not just for retina but also on the glaucoma side. I think there's still a little bit of headwind going into '23. We'll have to manage that. So I think that I see is the biggest headwind for the business, not just the retina piece. And I think we have been generally successful on the supply chain side. I think it is safe to say that we haven't missed a lot of revenue due to shortages. The team has done a good job here. But that still casts a little all over the business. But I think for most part, I think, at this point, it's the currency and some inflationary risk that we're all dealing with, probably the biggest factor into '23.

然後我認為你問的最後一個問題是逆風。我認為存在某種不確定性。在 22 財年的大部分時間裡，我們遇到了美元走強的不利因素，這影響了 OUS 的銷售，不僅是視網膜，還有青光眼方面。我認為進入 23 年仍有一些不利因素。我們必須解決這個問題。所以我認為我看到的是業務最大的阻力，而不僅僅是視網膜片。我認為我們在供應鏈方面總體上是成功的。我認為可以肯定地說，我們並沒有因為短缺而錯過很多收入。團隊在這裡做得很好。但這仍然對整個業務產生了影響。但我認為，在大多數情況下，我認為，在這一點上，我們都在處理貨幣和一些通脹風險，這可能是進入 23 年的最大因素。

And this concludes the Q&A session. I'd now like to turn the call back over to Dave Bruce for any closing remarks.

問答環節到此結束。我現在想將電話轉回 Dave Bruce 以聽取任何結束語。

Thank you, operator. Thank you all for joining us. We're looking forward to a strong 2023 performance and reporting to you in upcoming quarterly results.

謝謝你，運營商。謝謝大家加入我們。我們期待 2023 年的強勁表現，並在即將到來的季度業績中向您報告。

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

謝謝。今天的電話會議到此結束。感謝您的參與。您現在可以斷開連接。