Sight Sciences Inc (SGHT) 2022 Q4 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Hello and welcome to Sight Sciences' Fourth Quarter 2022 Earnings Results. (Operator Instructions)

    您好,歡迎來到 Sight Sciences 的 2022 年第四季度收益結果。 (操作員說明)

  • I would now like to hand the conference over to Trip Taylor of Investor Relations. You may begin.

    我現在想將會議交給投資者關係部的 Trip Taylor。你可以開始了。

  • Philip Taylor - Associate

    Philip Taylor - Associate

  • Thank you for participating in today's call. Presenting today are Sight Sciences Co-Founder and Chief Executive Officer, Paul Badawi; Interim Chief Financial Officer, Jim Rodberg; and Head of Corporate Strategy, Tom Huang. Earlier today, Sight Sciences released financial results for the 3 months and full year ended December 31, 2022. A copy of the press release is available on the company's website at investors.sightsciences.com.

    感謝您參加今天的電話會議。今天出席的有 Sight Sciences 聯合創始人兼首席執行官 Paul Badawi;臨時首席財務官 Jim Rodberg;和企業戰略主管 Tom Huang。今天早些時候, Sight Sciences 發布了截至2022年12月31日的三個月和全年的財務業績。新聞稿的副本可在公司網站 investors.sightsciences.com 上獲取。

  • I would like to remind everyone that comments made by management today and answers to questions will include forward-looking statements within the meaning of the federal securities laws. Those include statements related to Sight Sciences' anticipated financial performance and operating results, market opportunity, the future impact of supply chain disruptions, business strategy and plans for developing and marketing new products.

    我想提醒大家,今天管理層發表的評論和對問題的回答將包括聯邦證券法意義上的前瞻性陳述。其中包括與 Sight Sciences 的預期財務業績和經營業績、市場機會、供應鏈中斷的未來影響、業務戰略以及開發和營銷新產品的計劃相關的聲明。

  • Forward-looking statements are based on estimates and assumptions as of today are neither promises nor guarantees and are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied by these statements. A description of some of the risks and uncertainties that could cause actual results to differ materially from those indicated by the forward-looking statements on this call can be found in the risk factors section of the annual report on Form 10-K that was filed today and other filings with the Securities and Exchange Commission. The company undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law.

    前瞻性陳述基於截至今天的估計和假設,既不是承諾也不是保證,並且存在可能導致實際結果與這些陳述明示或暗示的結果大不相同的風險和不確定性。在今天提交的 10-K 表格年度報告的風險因素部分,可以找到可能導致實際結果與本次電話會議的前瞻性陳述所表明的結果存在重大差異的一些風險和不確定性的描述以及向證券交易委員會提交的其他文件。除非法律要求,否則公司不承擔公開更新或修改任何前瞻性陳述的義務。

  • I will now turn the call over to Paul.

    我現在將把電話轉給保羅。

  • Paul Badawi - Co-Founder, President, CEO & Director

    Paul Badawi - Co-Founder, President, CEO & Director

  • Thanks, Trip. In our first full year as a public company, we made great strides fulfilling our mission to improve the lives of patients with glaucoma and dry eye. We are grateful for the trust and partnership our customers, physicians and patients have placed in us. In 2022, we grew total revenue by 46% to $71.3 million and executed our commercial and operational initiatives to further solidify our position as the innovation and efficacy leader in MIGS and dry eye. We exercised rigorous financial discipline to rationalize operating expenses and reduce burn as planned in the third quarter which bolsters our belief that our $185 million cash balance at the end of 2022 is sufficient to support our growth plans and achieve cash flow breakeven in 2025 with a substantial cash cushion.

    謝謝,旅行。作為上市公司的第一個完整年度,我們在履行改善青光眼和乾眼症患者生活的使命方面取得了長足進步。我們感謝客戶、醫生和患者對我們的信任和合作。 2022 年,我們的總收入增長了 46%,達到 7130 萬美元,並執行了我們的商業和運營計劃,以進一步鞏固我們作為 MIGS 和乾眼症創新和療效領導者的地位。我們實施了嚴格的財務紀律,以在第三季度按計劃合理化運營支出並減少燒錢,這增強了我們的信念,即我們在 2022 年底的 1.85 億美元現金餘額足以支持我們的增長計劃並在 2025 年實現現金流盈虧平衡現金緩衝。

  • On the commercial front, we continue to propel market penetration and expansion with both the OMNI surgical system and TearCare system, expand our current addressable markets with the successful launch of SION, our innovative bladeless goniotomy technology and advance our efforts to establish fair market access and reimbursement for our dry eye treatment technology. We also announced several publications providing clinical support for broadening the use case for our core products and made great progress with our ongoing clinical trial programs. Our fourth quarter results exhibited strong sustained revenue growth and meaningful impact from our cost rationalization program.

    在商業方面,我們繼續通過 OMNI 手術系統和 TearCare 系統推動市場滲透和擴張,通過成功推出我們創新的無刀片前房角切開術 SION 擴大我們目前的目標市場,並推進我們建立公平市場准入和報銷我們的干眼症治療技術。我們還發布了幾份出版物,為擴大我們核心產品的用例提供臨床支持,並在我們正在進行的臨床試驗計劃中取得了巨大進展。我們第四季度的業績顯示出強勁的持續收入增長以及我們的成本合理化計劃帶來的重大影響。

  • Our fourth quarter total revenue increased to $20.5 million, up 40% compared to the fourth quarter of 2021. Notably, we grew revenue 10% sequentially, while decreasing both quarterly cash burn by 27% or $5.5 million and quarterly OpEx by 10% or $3.7 million versus the third quarter. Surgical glaucoma revenue was $18.8 million in Q4 2022, growing 35% year-over-year and 10% compared to Q3 and dry eye revenue was $1.8 million, growing 135% year-over-year and 12% compared to Q3.

    我們第四季度的總收入增至 2050 萬美元,比 2021 年第四季度增長 40%。值得注意的是,我們的收入環比增長 10%,同時季度現金消耗減少 27% 或 550 萬美元,季度運營支出減少 10% 或 3.7 美元百萬與第三季度相比。 2022 年第四季度,青光眼手術收入為 1880 萬美元,同比增長 35%,環比增長 10%;乾眼症收入為 180 萬美元,同比增長 135%,環比增長 12%。

  • I will now discuss the progress and strategic focus for our business units starting with surgical glaucoma. Our growth metrics demonstrate further adoption and utilization of our OMNI and SION technologies as surgeons continue to embrace the new minimally invasive glaucoma surgery techniques enabled by these important innovations. As a reminder, our core mission in surgical glaucoma is to provide surgeons with the best solutions for their patients regardless of severity of disease or lens status. We continue to advance our growth initiatives which include: one, expanding the large and growing moderate to advanced combination cataract segment and the considerably larger stand-alone MIGS segment with Omni's differentiated efficacy profile; two, driving adoption and utilization of SION among specific subsets of surgeons who choose a more basic procedure; and three, increasing our total share of MIGS with our OMNI and SION technologies.

    我現在將從手術青光眼開始討論我們業務部門的進展和戰略重點。我們的增長指標表明我們的 OMNI 和 SION 技術得到了進一步的採用和利用,因為外科醫生繼續接受這些重要創新所帶來的新的微創青光眼手術技術。提醒一下,我們在手術青光眼方面的核心使命是為外科醫生為患者提供最佳解決方案,無論患者的疾病嚴重程度或晶狀體狀態如何。我們繼續推進我們的增長計劃,其中包括:第一,擴大大型且不斷增長的中度至晚期混合性白內障細分市場,以及具有 Omni 差異化療效的相當大的獨立 MIGS 細分市場;第二,在選擇更基本程序的特定外科醫生子集中推動 SION 的採用和利用;第三,通過我們的 OMNI 和 SION 技術增加我們在 MIGS 中的總份額。

  • Our growth has significantly outpaced the overall mix market. We are taking share in combination cataract procedures and expanding MIGS beyond its narrow legacy confines. We believe Omni is the only technology that offers the efficacy, functionality and clinical results to support long-term market expansion and penetration of the entire 6-plus billion MIGS market opportunity as evidenced by our growing penetration and sticky customer base. We continue to see a natural progression of surgeons who first learn to use OMNI technology in combination with cataract for patients with less severe POAG, then expand their use cases to patients with more severe POAG and to stand-alone use in patients that do not require cataract surgery. In the fourth quarter, we maintained a greater than 99% developed customer retention rate for OMNI while growing active accounts by 24% since the end of 2021.

    我們的增長速度大大超過了整體混合市場。我們正在參與聯合白內障手術,並將 MIGS 擴展到其狹窄的遺留範圍之外。我們相信 Omni 是唯一能夠提供功效、功能和臨床結果以支持長期市場擴張和滲透整個 6+0 億 MIGS 市場機會的技術,我們不斷增長的滲透率和粘性客戶群證明了這一點。我們繼續看到外科醫生的自然進步,他們首先學習將 OMNI 技術與白內障結合用於 POAG 較輕的患者,然後將他們的用例擴展到 POAG 較嚴重的患者,並在不需要的患者中單獨使用白內障手術。在第四季度,我們為 OMNI 保持了超過 99% 的開發客戶保留率,同時自 2021 年底以來活躍賬戶增長了 24%。

  • Among accounts who placed OMNI orders in both the fourth quarter of 2022 and the fourth quarter of 2021, OMNI utilization increased 28%. We believe we are both increasing our market share in legacy combination cataract and expanding the market beyond legacy combination cataract procedures and towards stand-alone procedures. These market expansion opportunities are substantial and very sticky for our OMNI technology due to its proven degree and consistency of efficacy. These important long-term efficacy-minded customers are among the most attractive in MIGS. To accelerate adoption and facilitate broader patient access, we have created a comprehensive program that includes targeted field resources, patient and physician education and programs focused on improving patient access to these new combination cataract and standalone procedures made possible by our OMNI technology.

    在 2022 年第四季度和 2021 年第四季度下了 OMNI 訂單的賬戶中,OMNI 使用率增長了 28%。我們相信,我們正在增加我們在傳統組合白內障手術中的市場份額,並將市場擴展到傳統組合白內障手術之外,並朝著獨立手術的方向發展。由於其經過驗證的程度和有效性的一致性,這些市場擴展機會對於我們的 OMNI 技術來說是巨大的和非常粘性的。這些重視長期功效的重要客戶是 MIGS 最具吸引力的客戶之一。為了加速採用並促進更廣泛的患者訪問,我們創建了一個綜合計劃,其中包括有針對性的現場資源、患者和醫生教育以及旨在改善患者對這些新組合白內障和獨立程序的訪問的計劃,這些程序通過我們的 OMNI 技術成為可能。

  • As part of this program, our team is actively educating the glaucoma community on our new real-world data recently published in international ophthalmology from TREY, our multicenter study that evaluated the safety and efficacy of OMNI in patients with uncontrolled IOP despite a history of trabecular bypass stent implantation at the time of cataract surgery. TREY highlighted that significant intraocular pressure reductions were achieved with a stand-alone OMNI technology intervention in patients who already had stent implanted at the time of cataract surgery. This study suggests OMNI could be a natural fit for stand-alone interventions for the over 1 million patients who have undergone combination cataract stent implantations.

    作為該計劃的一部分,我們的團隊正在積極地向青光眼社區宣傳我們最近在 TREY 的國際眼科雜誌上發表的新的真實世界數據,我們的多中心研究評估了 OMNI 在儘管有小梁病史但眼壓不受控制的患者中的安全性和有效性白內障手術時旁路支架植入術。 TREY 強調,對於在白內障手術時已經植入支架的患者,通過獨立的 OMNI 技術干預可顯著降低眼內壓。這項研究表明,對於超過 100 萬接受過聯合白內障支架植入術的患者,OMNI 可能是獨立干預的自然選擇。

  • Here is an example of what we are regularly seeing in the real world. One recent case at a prestigious West Coast medical school involved a patient with low 20s IOP on 3 medications after combo cataract stent implantation. Stand-alone intervention with our OMNI technology decreases patient's IOP to 14 millimeters mercury on just one medication after 6 months. Needless to say, the patient and surgeon were very happy to avoid an invasive conventional surgery. This is just one example of the type of results that we believe OMNI can consistently deliver. To further demonstrate our market-leading efficacy, we have partnered with the data and technology provider, Verana Health.

    這是我們在現實世界中經常看到的一個例子。最近在一所著名的西海岸醫學院發生的一個案例涉及一名 20 多歲的低眼壓患者,該患者在聯合白內障支架植入術後服用了 3 種藥物。 6 個月後,使用我們的 OMNI 技術進行的獨立干預僅使用一種藥物即可將患者的 IOP 降低至 14 毫米汞柱。不用說,患者和外科醫生都非常高興避免侵入性傳統手術。這只是我們相信 OMNI 能夠始終如一地交付的結果類型的一個例子。為了進一步證明我們市場領先的功效,我們與數據和技術提供商 Verana Health 合作。

  • Our partnership leverages the American Academy of Ophthalmology's IRIS Registry of real-world data to analyze postsurgical outcomes for the leading mix technologies in the U.S., including OMNI, iStent and Hydrus. The first phase of the study analyzes IOP and medication reduction in 77,391 patients out to 2 years. This is the largest collection of MIGS data ever studied and offers compelling real-world evidence that we believe will demonstrate the clinical superiority of our OMNI technology. We plan to present and publish these groundbreaking study results, including comparative IOP and medication reduction outcomes at the one and 2 year marks at multiple medical meetings and in peer-reviewed literature throughout 2023. We believe our 4 other ongoing implant studies will further corroborate the results of TREY and IRIS in both combination cataract and stand-alone settings to further propel our share-taking and market expansion progress.

    我們的合作夥伴關係利用美國眼科學會的真實世界數據 IRIS 註冊來分析美國領先的混合技術(包括 OMNI、iStent 和 Hydrus)的術後結果。該研究的第一階段分析了 77,391 名患者 2 年內的 IOP 和藥物減少情況。這是有史以來最大的 MIGS 數據集,提供了令人信服的真實世界證據,我們相信這些證據將證明我們的 OMNI 技術的臨床優勢。我們計劃在整個 2023 年的多個醫學會議和同行評審文獻中展示和發布這些突破性的研究結果,包括第一年和第二年的比較眼壓和藥物減少結果。我們相信我們正在進行的其他 4 項植入研究將進一步證實TREY 和 IRIS 在組合白內障和獨立設置中的結果,進一步推動我們的股份收購和市場擴張進程。

  • Surgeon feedback from our clinical trials and real-world usage informs our innovation. We seek to continually improve clinical outcomes by improving functionality and usability, innovating creatively and raising the technological bar within MIGS. Earlier this month, we announced the launch of our newest OMNI technology called the Ergo-Series at the recent American Glaucoma Society Meeting. As with our other technologies, the Ergo-Series incorporates direct input from many of our customers and was designed entirely in-house.

    來自我們臨床試驗和實際使用情況的外科醫生反饋為我們的創新提供了信息。我們尋求通過改進功能和可用性、創造性創新和提高 MIGS 的技術標準來不斷改進臨床結果。本月早些時候,我們在最近的美國青光眼協會會議上宣布推出名為 Ergo 系列的最新 OMNI 技術。與我們的其他技術一樣,Ergo 系列採用了我們許多客戶的直接輸入,並且完全是內部設計的。

  • We're very pleased with the enthusiastic reception it has received thus far and the feedback confirms that our continuous enhancements to usability are key reasons surgeons love OMNI and choose it as their preferred MIGS technology. The Ergo-Series technology sets a new standard in circumferential glaucoma surgery and is just the latest in our long line of best-in-class technologies. This brings us to our newest product, the SION surgical instrument, the world's first bladeless goniotomy technology.

    我們對迄今為止收到的熱烈反響感到非常高興,反饋證實我們不斷提高可用性是外科醫生喜歡 OMNI 並選擇它作為首選 MIGS 技術的關鍵原因。 Ergo 系列技術為環狀青光眼手術樹立了新標準,並且是我們同類最佳技術系列中的最新產品。這為我們帶來了我們的最新產品 SION 手術器械,這是世界上第一個無刀片房角切開術技術。

  • We designed SION to allow surgeons to smoothly, efficiently and reliably excise and remove several clock hours of diseased trabecular meshwork tissue via an ab interno approach. SION is an ideal solution for a subset of patients prioritizing a simpler goniotomy procedure, complementing our OMNI technology broad indication for use and leading efficacy. The fourth quarter with our commercial team's first full quarter offer in SION following its limited launch in August of 2022. Surgeon feedback on the instrument continues to be extremely positive, particularly around procedural smoothness, a less traumatic goniotomy and improved ease of use. The ideal customers for SION fall outside of OMNI's optimal product market fit and we have observed minimal overlap in our analysis of early ordering patterns for SION customers.

    我們設計 SION 是為了讓外科醫生能夠通過 ab interno 方法順利、高效和可靠地切除和去除幾個時鍾小時的病變小梁網組織。 SION 是優先考慮更簡單的房角切開術的一部分患者的理想解決方案,補充了我們 OMNI 技術廣泛的使用適應症和領先的療效。第四季度,我們的商業團隊在 SION 於 2022 年 8 月有限推出後首次提供完整的季度報價。外科醫生對該儀器的反饋仍然非常積極,特別是在程序平穩性、創傷性較小的房角切開術和改進的易用性方面。 SION 的理想客戶不在 OMNI 的最佳產品市場契合範圍內,我們在對 SION 客戶的早期訂購模式的分析中觀察到最小的重疊。

  • In addition to adding completely new accounts and reviving dormant accounts, we saw a significant uplift in accounts that use both OMNI and SION technologies. Among accounts that ordered OMNI in the fourth quarter of 2021 and both OMNI and SION in the fourth quarter of 2022, average revenue per facility increased by 32%. Encouragingly, we saw utilization of our OMNI technology increased 12% in these accounts even as they added SION to their armamentarium.

    除了添加全新賬戶和恢復休眠賬戶外,我們還看到同時使用 OMNI 和 SION 技術的賬戶數量顯著增加。在 2021 年第四季度訂購 OMNI 以及 2022 年第四季度訂購 OMNI 和 SION 的客戶中,每個設施的平均收入增長了 32%。令人鼓舞的是,我們看到這些客戶對我們的 OMNI 技術的利用率增加了 12%,即使他們將 SION 添加到他們的武器庫中也是如此。

  • Our portfolio approach has already increased revenue per account. We also continue to make progress bringing OMNI technology to international markets. We launched direct operations in Germany, our second direct OUS market in January of this year. Germany along with the U.K., our first direct OUS market are 2 of the largest MIGS markets in the world. We've begun laying the groundwork in several other OUS markets and plan to proceed as prudently and aggressively as market access, regulatory and commercial conditions permit.

    我們的投資組合方法已經增加了每個賬戶的收入。我們還繼續取得進展,將 OMNI 技術推向國際市場。今年 1 月,我們在德國開展了直接運營,這是我們的第二個直接 OUS 市場。德國和英國是我們的第一個直接 OUS 市場,它們是世界上最大的 MIGS 市場中的兩個。我們已經開始在其他幾個 OUS 市場奠定基礎,併計劃在市場准入、監管和商業條件允許的情況下謹慎和積極地推進。

  • We couldn't be more excited to deliver the power of Sight to improve patients' lives around the world. Transitioning now to our dry eye business, where we continue to focus on establishing fair market access and reimbursement for dry eye treatment procedures. Our success introducing TearCare to over 1,000 accounts, including over 400 new accounts in 2022, spotlights the pent-up demand for effective dry eye treatments, especially interventional eyelid procedures.

    我們非常高興能夠傳遞 Sight 的力量來改善世界各地患者的生活。現在過渡到我們的干眼症業務,我們繼續專注於建立公平的市場准入和乾眼症治療程序的報銷。我們成功地將 TearCare 引入了 1,000 多個客戶,包括 2022 年的 400 多個新客戶,凸顯了對有效乾眼症治療,尤其是眼瞼介入手術的被壓抑需求。

  • Note that we accomplished the thousand account milestone while still in a controlled launch deploying only 20 sales representatives. Given the 14 million diagnosed evaporative dry eye sufferers in the U.S. and the growing prevalence of the disease, we believe the lack of fair market access to reimburse effective dry eye treatments is one of the greatest problems and opportunities in eye care today.

    請注意,我們在僅部署 20 名銷售代表的受控發布中完成了千個客戶里程碑。鑑於美國有 1400 萬確診的蒸發性乾眼症患者以及該疾病的患病率不斷上升,我們認為缺乏公平的市場准入來報銷有效的干眼症治療是當今眼保健領域最大的問題和機遇之一。

  • We have built a foundation from which TearCare can scale rapidly, adding just one single additional treatment per week for our existing customer base would quadruple the size of our dry eye revenues. So it is very easy to appreciate just how big this market can become with appropriate reimbursement. Pioneering fair market access will require strong payer-centric clinical data to demonstrate TearCare's health benefits to patients and economic benefits to insurers.

    我們已經建立了 TearCare 可以快速擴展的基礎,每週為我們現有的客戶群增加一次額外的治療將使我們的干眼收入規模翻兩番。因此,很容易理解通過適當的報銷,這個市場可以變得有多大。開創性的公平市場准入將需要強大的以支付者為中心的臨床數據來證明 TearCare 對患者的健康益處和對保險公司的經濟利益。

  • We custom tailored our SAHARA RCT with extensive input from medical directors at 8 different payors to understand inform the clinical foundation required to successfully support reimbursement coverage for TearCare. After completing enrollment of SAHARA in the third quarter of 2022, we remain on track to provide the initial 6-month data readout by the second half of 2023.

    我們根據 8 個不同付款人的醫療主管的廣泛意見定制了我們的 SAHARA RCT,以了解成功支持 TearCare 報銷範圍所需的臨床基礎。在 2022 年第三季度完成 SAHARA 的註冊後,我們仍有望在 2023 年下半年提供最初的 6 個月數據讀出。

  • As a reminder, this 6-month endpoint is powered to evaluate the superiority of TearCare treatments versus the leading multibillion-dollar dry eye prescription eye drop Restasis. With over 300 subjects, we believe SAHARA is the largest dry eye device study ever and the first to attempt to demonstrate the superiority of a device versus the most successful daily prescription eye drop. The 6-month study period designed to allow Restasis to achieve maximum efficacy also covers a much longer study period than the one to 3 month endpoints typical in other dry eye studies. SAHARA is in all respect, a very ambitious study but one that is also very worthwhile given the unmet need that we are seeking to address.

    提醒一下,這個 6 個月的終點能夠評估 TearCare 治療與領先的價值數十億美元的干眼症處方滴眼液 Restasis 相比的優越性。我們相信 SAHARA 有超過 300 名受試者,是有史以來規模最大的干眼設備研究,也是第一個試圖證明設備與最成功的每日處方眼藥水相比的優越性的研究。旨在讓 Restasis 達到最大療效的 6 個月研究期也涵蓋了比其他乾眼研究中典型的一到三個月終點更長的研究期。 SAHARA 在所有方面都是一項非常雄心勃勃的研究,但考慮到我們正在尋求解決的未滿足需求,它也非常值得。

  • In summary, we drove significant growth with all 3 of our category-leading products and made substantial progress expanding our opportunities in MIGS and dry eye. We remain dedicated to increasing physician adoption and utilization across our portfolio and increasing the number of customers and patients we serve. Looking ahead, we are focused on leveraging our procedure productive field team and increasing body of clinical evidence to train new customers and broaden use cases with each of our products with the ultimate goal of generating sustainable growth while continually improving operating efficiency and maintaining strict financial discipline. With these factors in mind, we are providing revenue guidance for 2023 of $89 million to $94 million.

    總之,我們通過所有 3 種類別領先的產品推動了顯著增長,並在擴大我們在 MIGS 和乾眼症方面的機會方面取得了實質性進展。我們仍然致力於提高醫生在我們產品組合中的採用率和利用率,並增加我們服務的客戶和患者數量。展望未來,我們專注於利用我們的程序高效現場團隊和越來越多的臨床證據來培訓新客戶並擴大我們每種產品的用例,最終目標是實現可持續增長,同時不斷提高運營效率並保持嚴格的財務紀律.考慮到這些因素,我們為 2023 年提供了 8900 萬至 9400 萬美元的收入指導。

  • We expect 2023 to exhibit similar seasonal impacts and quarterly revenue distribution that we saw in 2022 with the first quarter stepping down sequentially versus the last quarter of 2022, then increasing as the year progresses. Specifically, we expect first quarter revenue to comprise 20% to 21% of the midpoint of our 2023 guidance, consistent with the first quarter of 2022. As it relates to operating expense, we continue to believe our reduced quarterly cash OpEx of approximately $30.5 million is an appropriate level of spend to meet our growth plan for the year.

    我們預計 2023 年將表現出與 2022 年類似的季節性影響和季度收入分佈,第一季度與 2022 年最後一個季度相比依次下降,然後隨著時間的推移而增加。具體而言,我們預計第一季度收入將占我們 2023 年指引中點的 20% 至 21%,與 2022 年第一季度一致。由於與運營費用相關,我們仍然認為我們的季度現金運營支出減少了約 3050 萬美元是滿足我們當年增長計劃的適當支出水平。

  • Before I turn the call over to Jim Rodberg, our interim CFO, to detail the fourth quarter financial results, I'd like to thank Jim and his team for stepping up and doing an absolutely phenomenal job. Jim?

    在我將電話轉給我們的臨時首席財務官 Jim Rodberg 詳細介紹第四季度財務業績之前,我要感謝 Jim 和他的團隊挺身而出並完成了一項絕對非凡的工作。吉姆?

  • Jim Rodberg - VP of Finance & Corporate Controller

    Jim Rodberg - VP of Finance & Corporate Controller

  • Thanks Paul. Total revenue for the fourth quarter was $20.5 million, representing 40% growth year-over-year and 10% growth sequentially. Surgical glaucoma revenues for the fourth quarter were $18.8 million, up 35% year-over-year and up 10% sequentially. We continue to show strong underlying growth fundamentals in customer retention and ordering facilities. Additionally, we saw a notable increase in utilization, which is a critical metric for our OMNI market expansion efforts. 941 facilities ordered OMNI during the fourth quarter compared to 913 facilities in the third quarter, demonstrating the continued combination of strong new customer acquisition activity and our high retention rate. Combined with our strong account adds for SION, our commercial team did a tremendous job introducing our technologies to customers in 2022.

    謝謝保羅。第四季度總收入為 2050 萬美元,同比增長 40%,環比增長 10%。第四季度青光眼手術收入為 1880 萬美元,同比增長 35%,環比增長 10%。我們繼續在客戶保留和訂購設施方面顯示出強勁的潛在增長基礎。此外,我們看到利用率顯著提高,這是我們 OMNI 市場擴張工作的關鍵指標。與第三季度的 913 家工廠相比,第四季度有 941 家工廠訂購了 OMNI,這表明強勁的新客戶獲取活動和我們的高保留率持續結合。結合我們為 SION 增加的強大客戶,我們的商業團隊在 2022 年向客戶介紹我們的技術方面做得非常出色。

  • Our surgical glaucoma customer acquisition funnel remains strong for both products, creating great momentum for 2023. We ended Q4 with over 2,300 U.S. surgeons trained on OMNI and approaching 300 on SION. We have made great progress and given the estimated 5,700 MIGS-trained surgeons in the U.S., we have a substantial runway to roll out both products to targeted surgeons. Our dry eye revenues for the fourth quarter were $1.8 million, up 135% year-over-year and up 12% sequentially. We grew our installed TearCare base to 1,042 facilities at year-end, up from 881 as of September 30 and over 550 at the end of 2021. Gross margin for the fourth quarter was 82% compared to 87% in the prior year period.

    我們的手術青光眼客戶獲取渠道對於這兩種產品來說仍然很強勁,為 2023 年創造了巨大的勢頭。我們在第四季度結束時有超過 2,300 名美國外科醫生接受了 OMNI 培訓,接近 300 名接受了 SION 培訓。我們取得了很大進展,鑑於美國估計有 5,700 名受過 MIGS 培訓的外科醫生,我們有足夠的時間向目標外科醫生推出這兩種產品。我們第四季度的干眼症收入為 180 萬美元,同比增長 135%,環比增長 12%。到年底,我們將已安裝的 TearCare 基地增加到 1,042 個設施,高於 9 月 30 日的 881 個和 2021 年底的 550 個以上。第四季度的毛利率為 82%,而去年同期為 87%。

  • The decrease was primarily due to product mix and a $500,000 write-off of legacy components that aren't required in our Omni Ergo-Series technology. Excluding the inventory charge, gross margin would have been 85% for the quarter in line with our expectations. Our operations team continues to perform well in the face of global supply chain issues, driving manufacturing efficiencies and top-tier margins. Total operating expenses for the fourth quarter were $33.9 million, an increase of 23% compared to $27.5 million in the fourth quarter of 2021 and importantly, a 10% decrease from $37.6 million in the third quarter of 2022. Excluding noncash compensation, depreciation and amortization, our cash operating expenses in the quarter were approximately $30.5 million. This is exactly in line with the normalized cash OpEx for the third quarter and the 2023 spending plan we described on our last call. R&D expenses were $5.2 million compared to $4.4 million in the fourth quarter of 2021.

    減少的主要原因是產品組合和我們的 Omni Ergo 系列技術不需要的舊組件註銷 500,000 美元。排除庫存費用,本季度毛利率為 85%,符合我們的預期。面對全球供應鏈問題,我們的運營團隊繼續表現出色,推動了製造效率和頂級利潤率。第四季度總運營費用為 3390 萬美元,比 2021 年第四季度的 2750 萬美元增長 23%,重要的是,比 2022 年第三季度的 3760 萬美元減少 10%。不包括非現金補償、折舊和攤銷,我們本季度的現金運營費用約為 3050 萬美元。這與我們在上次電話會議上描述的第三季度標準化現金運營支出和 2023 年支出計劃完全一致。研發費用為 520 萬美元,而 2021 年第四季度為 440 萬美元。

  • And SG&A was $28.7 million compared to $31.5 million in Q3 and $23.1 million in the fourth quarter of 2021. Both SG&A and R&D increases year-over-year were driven by growth in personnel along with continued strategic investments in new and ongoing initiatives. Our loss from operations for the fourth quarter was $17.1 million compared to a loss of $21.8 million in the third quarter of 2022 and $14.7 million for the fourth quarter of 2021. We had a net loss of $16.9 million or $0.35 per share in the quarter on a weighted average share count of 48.2 million shares compared to a net loss of $15.9 million or $0.34 per share for the fourth quarter of 2021 based on a weighted average share count of 47.4 million shares.

    SG&A 為 2870 萬美元,而 2021 年第三季度為 3150 萬美元,第四季度為 2310 萬美元。SG&A 和 R&D 的同比增長均受到人員增長以及對新的和正在進行的計劃的持續戰略投資的推動。我們第四季度的運營虧損為 1,710 萬美元,而 2022 年第三季度和 2021 年第四季度分別虧損 2,180 萬美元和 1,470 萬美元。本季度我們的淨虧損為 1,690 萬美元或每股 0.35 美元根據 4740 萬股的加權平均股數,2021 年第四季度的加權平均股數為 4820 萬股,淨虧損為 1590 萬美元或每股 0.34 美元。

  • We ended the quarter with $185 million of cash and cash equivalents and $33.3 million of long-term debt, including $1.7 million of debt discount. In the fourth quarter, cash burn was reduced by 27% compared to the third quarter of 2022. We expect operating loss and cash burn will continue to decrease as our business model begins to flex the considerable operating leverage driven by our high gross margins. As evidenced in our discussion of operating expenses and cash burn, we continue to proactively manage our liquidity and operating expenses to maintain our strong cash position. We are confident that our continued and robust growth trends, market-leading positions in MIGS and MGD, strong balance sheet, leading gross margins and disciplined spend can drive us to positive free cash flow in 2025 while preserving a substantial cash cushion.

    本季度末,我們擁有 1.85 億美元的現金和現金等價物以及 3330 萬美元的長期債務,包括 170 萬美元的債務貼現。與 2022 年第三季度相比,第四季度的現金消耗減少了 27%。我們預計,隨著我們的業務模式開始調整由高毛利率驅動的可觀經營槓桿,經營虧損和現金消耗將繼續減少。正如我們對運營費用和現金消耗的討論所證明的那樣,我們繼續積極管理我們的流動性和運營費用,以保持我們強大的現金狀況。我們相信,我們持續強勁的增長趨勢、在 MIGS 和 MGD 中的市場領先地位、強勁的資產負債表、領先的毛利率和紀律嚴明的支出可以推動我們在 2025 年實現正自由現金流,同時保留大量現金緩衝。

  • With that, operator, you may open the line for questions. Tom Huang, our Head of Corporate Strategy, will also join us for Q&A.

    話務員,您可以打開問題熱線。我們的企業戰略主管 Tom Huang 也將加入我們的問答環節。

  • Operator

    Operator

  • (Operator Instructions) Our first question comes from the line of Tom Stephan with Stifel.

    (操作員說明)我們的第一個問題來自 Stifel 的 Tom Stephan。

  • Thomas M. Stephan - Associate

    Thomas M. Stephan - Associate

  • I'll start with guidance. Paul can you elaborate a bit on what it factors in. Just when it comes to competition in glaucoma. Obviously, there's a stand-alone stent and the VISCO delivery device that are going to be incremental in 2023 and maybe if it's easier to lay it out this way I guess. How do you expect competitive pressures in 2023 will compare to those that were experienced last year?

    我將從指導開始。保羅,你能詳細說明一下它的影響因素嗎?就在青光眼競爭方面。顯然,有一個獨立的支架和 VISCO 輸送裝置將在 2023 年增加,我猜如果以這種方式佈置它可能更容易。與去年相比,您預計 2023 年的競爭壓力如何?

  • Paul Badawi - Co-Founder, President, CEO & Director

    Paul Badawi - Co-Founder, President, CEO & Director

  • Yes. Tom, thanks for the question. I'd say we're entering this year feeling as good as ever. We saw a number of new entrants, new products introduced last year and I think our quarterly performance, very consistent quarterly performance speaks for itself. I think we're -- we actually see a more stabilized environment this year compared to last year even with the new entrants. In terms of the stand-alone stents, we welcome new entrants into the $4 billion to $5 billion stand-alone MIGS market. I think the more opportunities there are to intervene and to change the practice of medicine and to shift this category from a medically focused category to an interventional category I think the more companies and product opportunities there are for the foreseeable future. For the next 5 years, I see that as probably being helpful versus competitive.

    是的。湯姆,謝謝你的提問。我會說我們進入今年感覺和以往一樣好。我們看到了一些新進入者,去年推出了新產品,我認為我們的季度業績,非常一致的季度業績不言自明。我認為我們 - 我們實際上看到今年的環境比去年更加穩定,即使有新進入者也是如此。在獨立支架方面,我們歡迎新進入者進入 40 億至 50 億美元的獨立 MIGS 市場。我認為乾預和改變醫學實踐以及將這一類別從以醫學為重點的類別轉變為介入類別的機會越多,我認為在可預見的未來,公司和產品的機會就越多。在接下來的 5 年裡,我認為這可能是有幫助的而不是競爭性的。

  • And moving on, just specifically to Sight, I think we're generally just very, very confident in the positive growth trends and the underlying strong fundamentals we continue to see commercially in both of our businesses, glaucoma and dry eye as well as a number of catalysts to think about this year on both the technology and clinical fronts. Commercially, we expect to continue doing what we've been doing for years which is taking share in mild to moderate combo cataract MIGS in the face of competition, right? That's nothing new. We've been doing that since launching OMNI years ago. We'll continue to expand the moderate to advanced combo cataract MIGS segment. That's a very attractive one. And we'll continue to expand the moderate to advanced stand-alone MIGS segment. We think that's the kind of the earliest market opportunity in stand-alone is probably moderate, hasn't really been exploited yet. Mild is probably down the road. So we're focused on the moderate to advanced stand-alone MIGS segments.

    繼續前進,特別是 Sight,我認為我們通常對積極的增長趨勢和潛在的強勁基本面非常非常有信心,我們繼續在我們的業務、青光眼和乾眼症以及一些業務中看到商業上的強勁基本面今年在技術和臨床方面考慮的催化劑。在商業上,我們希望繼續做我們多年來一直在做的事情,即面對競爭在輕度至中度組合性白內障 MIGS 中佔有一席之地,對嗎?這不是什麼新鮮事。自多年前推出 OMNI 以來,我們一直在這樣做。我們將繼續擴大中度至晚期組合性白內障 MIGS 細分市場。這是一個非常有吸引力的。我們將繼續擴大中等到高級的獨立 MIGS 細分市場。我們認為這種最早的單機市場機會可能是溫和的,還沒有真正被利用。溫和的可能是在路上。因此,我們專注於中等到高級的獨立 MIGS 部分。

  • On the TearCare side of our business, we expect to continue driving adoption of TearCare to new customers as well as focusing on improving utilization within existing dry eye accounts. In terms of other catalysts on the technology side for 2023, we're very happy with our Omni Ergo launch. Earlier this year, it's going extremely well. The benefits of the enhancement and the usability enhancements are exceeding our expectations and our surgeons' expectations. And with SION, we're entering this year for the first time with a portfolio of products, early insights, as we talked about, showed at our portfolio approach is driving enhanced revenue opportunities within our accounts.

    在我們業務的 TearCare 方面,我們希望繼續推動新客戶採用 TearCare,並專注於提高現有乾眼症客戶的利用率。就 2023 年技術方面的其他催化劑而言,我們對 Omni Ergo 的發布感到非常高興。今年早些時候,它進行得非常順利。增強和可用性增強的好處超出了我們的預期和我們的外科醫生的預期。而對於 SION,我們今年首次進入了產品組合,正如我們所談到的,早期洞察表明我們的產品組合方法正在推動我們賬戶中增加收入的機會。

  • And Tom, the last thing I'll just mention in terms of 2023 and our outlook and how we feel about in catalysts, if you think about clinical catalysts, we have TREY that were a publication that we're leveraging now that's OMNI's use in pseudophakic patients who have a history of trabecular bypass at the time of cataract surgery. If 1 million stents have been implanted worldwide, if you take roughly $1,000 ASP, that's a $1 billion market opportunity.

    湯姆,關於 2023 年和我們的前景以及我們對催化劑的看法的最後一件事,如果你考慮臨床催化劑,我們有 TREY,這是我們現在正在利用的出版物,這是 OMNI 在白內障手術時有小梁旁路術病史的假晶狀體患者。如果全世界植入了 100 萬個支架,如果您採用大約 1,000 美元的 ASP,那就是 10 億美元的市場機會。

  • So that's happening now. We're leveraging that data now. In stand-alone we talked about the Verana data that we expect to be publishing later this year and presenting at various conferences. That's a very exciting comparative MIGS data set. And lastly, SAHARA, we've got a tremendous milestone coming up in terms of the 6-month readout showing how TearCare interventional eyelid procedures compared to the leading dry eye prescription Rx. So with all of those things down Tom I think all in all, we're very confident in the positive growth trends we're seeing across our businesses and throughout 2023.

    所以現在正在發生這種情況。我們現在正在利用這些數據。在獨立版中,我們討論了我們預計將在今年晚些時候發布並在各種會議上展示的 Verana 數據。這是一個非常令人興奮的比較 MIGS 數據集。最後,SAHARA,我們在 6 個月的讀數方面取得了一個巨大的里程碑,顯示了 TearCare 介入眼瞼手術與領先的干眼症處方 Rx 相比如何。因此,湯姆,我認為總的來說,由於所有這些事情的發生,我們對我們在整個業務和整個 2023 年看到的積極增長趨勢充滿信心。

  • Thomas M. Stephan - Associate

    Thomas M. Stephan - Associate

  • That's helpful. Great color. And then to pivot a bit just to the profitability plan. It's good to see you guys continue to expect breakeven in 2025. I guess what does this assume in terms of dry eye and notably SAHARA? Do those plans assume SAHARA hits the endpoint. I'm just curious if it's fair to think about if that were the case, the company may be leaning into commercialization and marketing efforts as reimbursement may start to come through. I guess what I'm asking is what do those profitability plans assume around dry eye and SAHARA?

    這很有幫助。很棒的顏色。然後稍微轉向盈利計劃。很高興看到你們繼續期望在 2025 年實現收支平衡。我想這對乾眼症尤其是撒哈拉沙漠有何影響?這些計劃是否假設 SAHARA 到達終點。我只是很好奇考慮是否公平,如果是這種情況,公司可能會傾向於商業化和營銷工作,因為報銷可能會開始通過。我想我要問的是這些盈利計劃對乾眼症和撒哈拉沙漠的假設是什麼?

  • Paul Badawi - Co-Founder, President, CEO & Director

    Paul Badawi - Co-Founder, President, CEO & Director

  • Thanks, Tom. Maybe Tom or Jim can add to this. I'll just talk about timing for SAHARA. We expect to have the readout soon within a few months. We expect to submit for publication in the -- roughly the third quarter of this year. In the ideal scenario we're aiming for a top journal as you can imagine. This assumes the results are successful, knock on wood there. But assuming a good time line, we could have something published by the end of the year and we would leverage that publication again assuming success early in 2024 working payor by payor or likely commercial payor by commercial payor. So as it relates to our projections now, we're not assuming SAHARA reimbursement success. We're assuming continued enhancements to our current cash pay business model which is continuing to sell to new dry eye accounts and continuing to drive improvements in reorder rates.

    謝謝,湯姆。也許 Tom 或 Jim 可以對此進行補充。我只想談談 SAHARA 的時機。我們預計將在幾個月內很快得到讀數。我們預計將在 - 大約今年第三季度提交出版。在理想情況下,我們的目標是像您想像的那樣成為頂級期刊。這個假設結果是成功的,敲木頭那裡。但假設有一個好的時間表,我們可以在今年年底之前發布一些東西,我們將再次利用該出版物,假設在 2024 年初取得成功,一個付款人一個付款人或可能的商業付款人一個商業付款人。因此,就我們現在的預測而言,我們不假設 SAHARA 報銷成功。我們假設繼續改進我們當前的現金支付業務模式,該模式將繼續向新的干眼症賬戶銷售產品,並繼續推動再訂購率的提高。

  • Tom Huang - Head of Corporate Strategy & Development

    Tom Huang - Head of Corporate Strategy & Development

  • Tom, this is Tom. Just to put another point on that. The medium-term growth expectations we've talked about in the past don't include a hockey stick for TearCare. It's kind of a steady as she goes projection for us.

    湯姆,這是湯姆。只是為了說明這一點。我們過去談到的中期增長預期不包括 TearCare 的曲棍球棒。當她為我們投射時,它有點穩定。

  • Operator

    Operator

  • Our next question comes from the line of Craig Bijou with Bank of America.

    我們的下一個問題來自美國銀行的 Craig Bijou。

  • Craig William Bijou - Research Analyst

    Craig William Bijou - Research Analyst

  • I wanted to start with SION and wanted to see if you guys would be willing to provide how much it contributed in the quarter or at least maybe some qualitative commentary recognizing that it's still early. And then how many of those 200 accounts overlap with your OMNI accounts? And then just thinking about 2023 and how to think about surgical glaucoma and the mix that -- the mix between SION and OMNI and how you guys think about that growth materializing between the 2 products?

    我想從 SION 開始,想看看你們是否願意提供它在本季度的貢獻,或者至少是一些定性評論,承認它還為時過早。那麼這 200 個帳戶中有多少與您的 OMNI 帳戶重疊?然後想想 2023 年,如何考慮手術青光眼以及 SION 和 OMNI 之間的混合以及你們如何看待這兩種產品之間實現的增長?

  • Tom Huang - Head of Corporate Strategy & Development

    Tom Huang - Head of Corporate Strategy & Development

  • Sure, Craig. This is Tom. Yes, we don't want to get too much into specifics on SION for competitive reasons. But I think it's fair to say that it's trending in the mid-single digits annualized range. Sorry can you repeat your other questions.

    當然,克雷格。這是湯姆。是的,出於競爭原因,我們不想過多地了解 SION 的細節。但我認為可以公平地說,它的年化趨勢在中等個位數範圍內。對不起,你能重複你的其他問題嗎?

  • Craig William Bijou - Research Analyst

    Craig William Bijou - Research Analyst

  • Yes, sure. On the accounts, the 200 accounts that you guys had, just wanted to know how much of an overlap that was with your OMNI users.

    是的,當然。關於帳戶,你們擁有的 200 個帳戶,只是想知道與您的 OMNI 用戶有多少重疊。

  • Tom Huang - Head of Corporate Strategy & Development

    Tom Huang - Head of Corporate Strategy & Development

  • A little over a third were brand-new accounts that were brand new to -- did not order SION did not order OMNI as well.

    三分之一多一點是全新的帳戶——沒有訂購 SION,也沒有訂購 OMNI。

  • Craig William Bijou - Research Analyst

    Craig William Bijou - Research Analyst

  • Got it. And one other follow-up on SION. Just thinking about 2023, how should we think about the -- whether it's the acceleration from kind of where revenue was in Q4? Or just any help in trying to think about the mix between OMNI and SION contribution in 2023?

    知道了。以及 SION 的另一項後續行動。想想 2023 年,我們應該如何考慮——這是否是第四季度收入增長的加速?或者對嘗試考慮 2023 年 OMNI 和 SION 貢獻之間的組合有什麼幫助嗎?

  • Tom Huang - Head of Corporate Strategy & Development

    Tom Huang - Head of Corporate Strategy & Development

  • Sure. I think we are continuing to prioritize OMNI as our flagship product. We do think that we'll have a nice growth year-over-year as we have a full year of contribution in SION. But again, the opportunity for SION is smaller than the one for OMNI. So I think you can take that as some guidance.

    當然。我認為我們將繼續優先考慮將 OMNI 作為我們的旗艦產品。我們確實認為我們將有一個很好的同比增長,因為我們在 SION 有全年的貢獻。但同樣,SION 的機會小於 OMNI 的機會。所以我認為你可以把它作為一些指導。

  • Craig William Bijou - Research Analyst

    Craig William Bijou - Research Analyst

  • Got it. That's helpful and if I can just follow up maybe on the last question on TearCare. I understand that you're not building into your assumptions a hockey stick or a significant acceleration in growth. But I would love to just hear the opportunity, what you guys think insurance coverage could do for TearCare and you've obviously been growing strong, growth has been strong in just the private pay market, but we would love to hear what could happen if you do get insurance.

    知道了。這很有幫助,如果我可以跟進關於 TearCare 的最後一個問題。我知道你並沒有在你的假設中建立曲棍球棒或增長的顯著加速。但我很想听聽這個機會,你們認為保險範圍可以為 TearCare 做些什麼,而且你們顯然一直在強勁增長,私人支付市場的增長一直很強勁,但我們很想听聽如果你確實得到了保險。

  • Paul Badawi - Co-Founder, President, CEO & Director

    Paul Badawi - Co-Founder, President, CEO & Director

  • Yes, Craig I'll take that one. I think with a successful SAHARA outcome, again, the end points one, the first is 6-month superiority readout to Restasis and then we're also following all 300-plus patients out for 2 years to show durability of TearCare treatment effect. I believe that if we are successful with SAHARA and successful in our payor efforts, again, this was a payor informed clinical trial protocol and design that this can be one of the most exciting opportunities that eyecare has seen in the past decade. We talked about what would happen to our revenue if our accounts added just a single treatment per week.

    是的,克雷格,我要那個。我認為 SAHARA 的結果是成功的,終點是第一個,第一個是 6 個月的優勢讀數,然後我們還跟踪所有 300 多名患者 2 年,以顯示 TearCare 治療效果的持久性。我相信,如果我們在 SAHARA 上取得成功並在我們的付款人努力中取得成功,那麼,這是一個付款人知情的臨床試驗方案和設計,這可能是過去十年眼保健領域最令人興奮的機會之一。我們討論瞭如果我們的客戶每週只增加一次治療,我們的收入會發生什麼變化。

  • You can imagine, again, dry eye is the number one reason for a patient visit to an eye care provider, number one, there is no meaningfully reimbursed interventional procedure for dry eye. And so if we can show to payors that the clinical value is there versus prescription eye drops, costly prescription eye drops and that the health economic value and the cost of such treatment are not only justified, but hopefully in payers' interests. Compared to costly prescription Rx, you can imagine how exciting this business model can become overnight.

    您可以再次想像,乾眼症是患者就醫的首要原因,第一,乾眼症沒有有意義的報銷干預程序。因此,如果我們能夠向付款人證明,與處方眼藥水相比,臨床價值是存在的,昂貴的處方眼藥水以及這種治療的健康經濟價值和成本不僅是合理的,而且有望符合付款人的利益。與昂貴的處方藥相比,您可以想像這種商業模式會在一夜之間變得多麼令人興奮。

  • Operator

    Operator

  • Our next question comes from the line of Joanne Wuensch with Citi.

    我們的下一個問題來自花旗銀行的 Joanne Wuensch。

  • Joanne Karen Wuensch - MD

    Joanne Karen Wuensch - MD

  • There are 2 and then I'll just put them right up to do with reimbursement. Can you please comment on any changes or stability you've seen in the reimbursement for SION and the OMNI procedure? And then the second one has to do with gross margins as you move towards your path to profitability and layer in TearCare, what happened?

    有 2 個,然後我會把它們放在報銷上。您能否評論一下您在 SION 和 OMNI 程序的報銷中看到的任何變化或穩定性?然後第二個與毛利率有關,因為您正在走向盈利之路並在 TearCare 中分層,發生了什麼?

  • Tom Huang - Head of Corporate Strategy & Development

    Tom Huang - Head of Corporate Strategy & Development

  • Joanne, why don't we take the second one first since that's top of mind. We continue to expect gross margins will stabilize in the mid-80s range as TearCare volumes increase their gross margins will approach that of OMNI. So I think for your models, mid-80s is a nice place to be.

    喬安妮,為什麼我們不先考慮第二個,因為這是最重要的。我們繼續預計毛利率將穩定在 80 年代中期,因為 TearCare 銷量增加,其毛利率將接近 OMNI。所以我認為對於你的模特來說,80 年代中期是個不錯的地方。

  • Paul Badawi - Co-Founder, President, CEO & Director

    Paul Badawi - Co-Founder, President, CEO & Director

  • Joanne, on the reimbursement question, let's go with OMNI first. OMNI, the code to bill OMNI, the canaloplasty code was revalued 2 years ago, the professional fee was revalued at the same time as the stent fees were revalued. And so we're now in the fully revalued phase, the reimbursement was adjusted to $600 for an OMNI procedure as of January 1. So we're operating with that economic profile.

    喬安妮,關於報銷問題,讓我們先談談 OMNI。 OMNI,賬單代碼 OMNI,運河成形術代碼在 2 年前被重估,專業費用在重估支架費用的同時被重估。因此,我們現在處於完全重估階段,從 1 月 1 日起,OMNI 程序的報銷調整為 600 美元。因此,我們正在以這種經濟狀況運營。

  • Relative to other procedures, I think is the key, the professional fee for performing OMNI has not dropped below any other professional fee for any competitive procedure. I think that's the key in assessing any potential pro fee reduction impact to OMNI utilization. It's sufficient, it's attractive. Nobody likes a reimbursement reduction, but it's sufficient for performing high-volume OMNI and it hasn't changed relative to any other competing procedure.

    相對於其他程序,我認為關鍵是執行 OMNI 的專業費用並未低於任何競爭性程序的任何其他專業費用。我認為這是評估任何潛在的專業費用減少對 OMNI 使用的影響的關鍵。足夠了,很吸引人。沒有人喜歡報銷減少,但它足以執行大量 OMNI,並且相對於任何其他競爭程序沒有改變。

  • For SION, goniotomy, hasn't been revalued for a while and so there is an expectation that at some point, goniotomy will be revalued. What does that mean for Sight? I think if goniotomy is revaluing the pro fee comes down quite a bit, there are a subset of surgeons or facilities who will perhaps rethink whether goniotomy is already just a subset of the MIGS OMNI again, is our leading product but I think even within that subset, some folks might rethink whether goniotomy is their procedure of choice or whether they want to move to something like canaloplasty with OMNI. I think it's -- even with a goniotomy adjustment, I can see movement towards OMNI, which is ultimately what we're driving towards.

    對於 SION,房角切開術有一段時間沒有被重新評估,因此預計在某個時候,房角切開術會被重新評估。這對 Sight 意味著什麼?我認為如果前房角切開術重新評估專業費用會大幅下降,那麼一部分外科醫生或設施可能會重新考慮前房角切開術是否已經只是 MIGS OMNI 的一個子集,是我們的領先產品,但我認為即使在其中子集,一些人可能會重新考慮前房角切開術是否是他們選擇的手術,或者他們是否想轉向使用 OMNI 進行的手術,如鼻腔成形術。我認為這是——即使進行前房角切開術調整,我也能看到向 OMNI 的轉變,這最終是我們正在努力的方向。

  • Operator

    Operator

  • Our next question comes from the line of Cecilia Furlong with Morgan Stanley.

    我們的下一個問題來自 Cecilia Furlong 與摩根士丹利的對話。

  • Cecilia E. Furlong - Equity Analyst

    Cecilia E. Furlong - Equity Analyst

  • I wanted to ask a follow-up on TearCare, really thinking about 2023 specifically and how you think about just installed base growth ahead of SAHARA and tied in with that too just your outlook that is incorporated in OpEx for further dry eye sales team growth post SAHARA 6-month data.

    我想問一個關於 TearCare 的後續行動,具體考慮 2023 年,以及你如何看待 SAHARA 之前的安裝基數增長,並與此相關聯,你的前景也被納入 OpEx,以進一步促進乾眼症銷售團隊的增長SAHARA 6 個月數據。

  • Paul Badawi - Co-Founder, President, CEO & Director

    Paul Badawi - Co-Founder, President, CEO & Director

  • Cecilia, in terms of the second part of your question on sales team growth, we haven't factored in a significant increase in commercial activity due to SAHARA this year because once we get the 6-month data it will take a few months to publish and get out there and being format ready to present to payors.

    Cecilia,關於你關於銷售團隊增長的問題的第二部分,我們沒有考慮到今年由於 SAHARA 而導致的商業活動的顯著增加,因為一旦我們獲得 6 個月的數據,將需要幾個月的時間才能發布走出去,準備好向付款人展示。

  • So we don't expect a significant impact until 2024. And I think we're expecting to see reimbursement when it happens on an incremental basis, not just flipping a switch and having the entire country go live at once. I think it's -- I think we'll be able to deploy resources regionally as we accumulate payor wins and be able to effectively and efficiently cover new markets or cover markets that have new reimbursement wins very effectively and show really strong growth that way.

    因此,我們預計在 2024 年之前不會產生重大影響。而且我認為我們希望在增量基礎上看到報銷,而不僅僅是撥動開關並讓整個國家立即上線。我認為這是 - 我認為我們將能夠在我們積累付款人勝利時在區域性部署資源,並且能夠有效和高效地覆蓋新市場或覆蓋具有新報銷勝利的市場非常有效並以這種方式顯示出非常強勁的增長。

  • Cecilia E. Furlong - Equity Analyst

    Cecilia E. Furlong - Equity Analyst

  • Great. And if I could follow up as well, just incorporating your OpEx outlook for that about $30.5 million. How should we think about R&D on a relative basis versus what we saw in Q4 tying in some of your pipeline products as well as clinical studies ongoing?

    偉大的。如果我也可以跟進,只需將您的 OpEx 展望納入大約 3050 萬美元。我們應該如何相對地考慮研發與我們在第四季度看到的與您的一些管道產品以及正在進行的臨床研究相關的情況?

  • Paul Badawi - Co-Founder, President, CEO & Director

    Paul Badawi - Co-Founder, President, CEO & Director

  • We expect to see a similar mix of as we saw in Q4 into 2023. And we're planning to be very diligent in our -- in any of the investments we make as we continue to manage the OpEx targets that we've set in our path to cash flow breakeven.

    我們預計到 2023 年將看到與我們在第四季度看到的類似的組合。我們計劃在我們進行的任何投資中非常勤奮,因為我們將繼續管理我們設定的運營支出目標我們的現金流盈虧平衡之路。

  • Operator

    Operator

  • Our next question comes from the line of Margaret Kaczor with William Blair.

    我們的下一個問題來自 Margaret Kaczor 和 William Blair 的台詞。

  • Malgorzata Maria Kaczor Andrew - Research Analyst & Partner

    Malgorzata Maria Kaczor Andrew - Research Analyst & Partner

  • I wanted to follow up maybe to start on the Ergo-Series of products and if you can share any specifics I guess on the average time of procedures, maybe efficiency stats for the data empirical versus the last generation.

    我想跟進可能從 Ergo 系列產品開始,如果你能分享我猜想的關於程序平均時間的任何細節,也許是數據經驗與上一代的效率統計數據。

  • Paul Badawi - Co-Founder, President, CEO & Director

    Paul Badawi - Co-Founder, President, CEO & Director

  • Margaret, yes, in terms of Ergo and the name of the game and MIGS and making a product or procedure, the go-to preferred, preferred MIGS option comes down to procedural ease of use and usability and obviously, clinical outcomes. And with Omni, we've seen the differentiated clinical outcomes and differentiated safety and efficacy profile over and over, and we continue to publish on that. So there remains opportunity to enhance the procedure and the usability, and that's what we were focused on with Omni Ergo. And we've upgraded the ergonomics, the hand piece. We've also upgraded and enhanced the technology at the most distal end of the device that allows the surgeon to access the disease outflow pathway and that's critical. Improving how a surgeon accesses the disease outflow pathway is critical.

    瑪格麗特,是的,就 Ergo 和遊戲名稱以及 MIGS 和製作產品或程序而言,首選、首選 MIGS 選項歸結為程序的易用性和可用性,以及顯然的臨床結果。借助 Omni,我們一遍又一遍地看到了差異化的臨床結果以及差異化的安全性和有效性概況,並且我們將繼續就此發表文章。因此,仍有機會增強程序和可用性,這就是我們對 Omni Ergo 的關注點。我們還升級了人體工程學手柄。我們還升級和增強了設備最遠端的技術,使外科醫生能夠進入疾病流出通路,這很關鍵。改進外科醫生進入疾病流出通路的方式至關重要。

  • And we think that there was an opportunity to modify some of the dimensions on our cannula and catheter and allow the surgeon more reproducible, quiet, less traumatic and consistent access into the canal. And once the surgeon gets into the canal with OMNI, the brilliant engineering of the device and design kind of takes over. So in terms of circumnavigating the canal up to 360 degrees and up to 2 time for both canaloplasty and trabeculotomy. The early feedback in terms of the enhancements we made to help the surgeon more reproducibly get into Schlemm's canal has been very, very positive I think I'd say it's surpassed even our expectations.

    我們認為有機會修改插管和導管的某些尺寸,讓外科醫生更可重複、更安靜、創傷更小、更一致地進入根管。一旦外科醫生使用 OMNI 進入根管,設備和設計的卓越工程就會接管。因此,就運河而言,最多 360 度環繞運河,運河成形術和小梁切開術最多 2 次。我們為幫助外科醫生更可重複地進入 Schlemm 管而進行的改進方面的早期反饋非常非常積極,我想我會說這甚至超出了我們的預期。

  • Malgorzata Maria Kaczor Andrew - Research Analyst & Partner

    Malgorzata Maria Kaczor Andrew - Research Analyst & Partner

  • Okay. That's helpful. And then if we could move to some of the DTC pilots that you guys have spoken to, can you share I guess, any progress in terms of being able to reach the TearCare patients, maybe those who had kind of stent implanted in the past who might be looking for a stand-alone solution. Have the DTC pilots, I guess, been useful and any other initiatives that you guys could put out there to reach these patients.

    好的。這很有幫助。然後,如果我們可以轉向你們已經談過的一些 DTC 飛行員,我想你們能分享一下在接觸 TearCare 患者方面取得的任何進展,也許是那些過去植入過支架的人可能正在尋找獨立的解決方案。我猜 DTC 試點是否有用,以及你們可以在那裡推出的任何其他舉措來接觸這些患者。

  • Paul Badawi - Co-Founder, President, CEO & Director

    Paul Badawi - Co-Founder, President, CEO & Director

  • Yes, thanks for that question. We're excited about the possibilities here. We have been working with a leading med tech DTC provider. I'll say that they conducted their own pilot prior to us entering into an engagement with them to understand whether the diseases that we're addressing glaucoma and dry eye would be good candidates for DTC strategies and those pilots that our partner did on their own executed on their own seemed very favorable. And so we've decided to enter into an agreement with them and run a pilot. In terms of timing, Margaret, the first month -- or sorry, first quarter of the year, this quarter has been the setup phase for the pilot DTC program and the second quarter of this year will be the actual execution phase where we'll run the program and hopefully by the end of that exercise, we'll be able to have an early read on how DTC is helping with our OMNI market development efforts. So stay tuned.

    是的,謝謝你提出這個問題。我們對這裡的可能性感到興奮。我們一直在與一家領先的醫療技術 DTC 提供商合作。我會說,在我們與他們接觸之前,他們進行了自己的試點,以了解我們正在解決的青光眼和乾眼症疾病是否適合 DTC 策略以及我們的合作夥伴自己進行的那些試點自己執行似乎非常有利。所以我們決定與他們達成協議並進行試點。就時間而言,瑪格麗特,第一個月——或者抱歉,今年第一季度,本季度是試點 DTC 計劃的設置階段,今年第二季度將是實際執行階段,我們將運行該程序,希望在該練習結束時,我們能夠及早了解 DTC 如何幫助我們開展 OMNI 市場開發工作。敬請期待。

  • Operator

    Operator

  • Our next question comes from the line of Matthew O'Brien with Piper Sandler.

    我們的下一個問題來自 Matthew O'Brien 和 Piper Sandler 的台詞。

  • Phillip Paul Dantoin - Research Analyst

    Phillip Paul Dantoin - Research Analyst

  • This is Phil on for Matt. Congrats for the great quarter. Just on guidance I don't think I heard anyone asked, but can you give us your puts and takes for what gets you to the top end of your range versus the bottom? Maybe what you're seeing in the broader MIGS market in terms of any headwinds, staffing, procedural headwinds, et cetera? And maybe by segment, what are your puts and takes for 2023? And I guess what I'm really trying to get at is TearCare grew about $3 million in 2022, can it grow another $3 million in 2023?

    這是 Phil on for Matt。祝賀這個偉大的季度。只是根據指導,我想我沒有聽到有人問過,但是你能給我們你的看跌期權和看跌期權是什麼讓你到達你的範圍的頂端而不是底部?也許您在更廣泛的 MIGS 市場中看到的任何逆風、人員配置、程序逆風等方面的情況?也許按細分市場,您對 2023 年的看跌期權和看跌期權是什麼?我想我真正想知道的是 TearCare 在 2022 年增長了約 300 萬美元,它能否在 2023 年再增長 300 萬美元?

  • Tom Huang - Head of Corporate Strategy & Development

    Tom Huang - Head of Corporate Strategy & Development

  • I think on the OMNI side of our business our surgical glaucoma with OMNI and SION, we have a history of taking share in the mild to moderate combo cataract segment, so we expect to continue building our business there. I think what will drive further upside to our plans and our historical performance is how well we can continue to expand the surgical glaucoma markets. And again, that's moderate to advanced combo cataract and moderate to advanced stand-alone. So we talked about a number of initiatives that we're executing on this year to help drive that continued market development. I think that's the market expansion opportunities or what provide, I think, a lot of the upside.

    我認為在我們業務的 OMNI 方面,我們與 OMNI 和 SION 的手術青光眼,我們在輕度至中度組合性白內障領域佔有份額的歷史,因此我們希望繼續在那裡建立我們的業務。我認為將進一步推動我們的計劃和我們的歷史表現的是我們如何繼續擴大手術青光眼市場。再一次,這是中度到高級的組合性白內障和中度到高級的獨立性白內障。因此,我們談到了我們今年正在執行的一些舉措,以幫助推動持續的市場發展。我認為這是市場擴張機會或我認為提供了很多好處的東西。

  • Phillip Paul Dantoin - Research Analyst

    Phillip Paul Dantoin - Research Analyst

  • That's really helpful and I guess just to sort of end it here. On the Verana Health, that partnership, how big could that be for your business in 2024 in terms of additional surgeons and adoption and that just your puts and takes would be helpful.

    這真的很有幫助,我想就此結束吧。在 Verana Health 上,這種合作關係在 2024 年對您的業務有多大的影響,就增加外科醫生和收養而言,只要您的投入和投入就會有所幫助。

  • Tom Huang - Head of Corporate Strategy & Development

    Tom Huang - Head of Corporate Strategy & Development

  • I mean we're really, really excited about the possibilities with the Verana data. It is -- they have access to millions of patients entered by patient data entered by the members of the American Academy of Ophthalmology. So it is the most comprehensive eye care database out there. And we are extremely excited about the ability to demonstrate OMNI's efficacy compared to the other devices out there. I don't think we'll be able -- I don't think we can translate that directly into increased penetration next year but we're very excited.

    我的意思是我們對 Verana 數據的可能性真的非常興奮。它是 - 他們可以訪問由美國眼科學會成員輸入的患者數據輸入的數百萬患者。所以它是目前最全面的眼保健數據庫。與其他設備相比,我們對能夠證明 OMNI 的功效感到非常興奮。我不認為我們能夠——我認為我們明年不能將其直接轉化為更高的滲透率,但我們非常興奮。

  • Paul Badawi - Co-Founder, President, CEO & Director

    Paul Badawi - Co-Founder, President, CEO & Director

  • Yes and I think it's -- what we really love about just a large volume of real-world clinical data. We design our products to help the -- help make the average surgeon deliver optimal clinical outcomes, right? And we talked about the Ergo-Series of Omni. That is success to us. Success is making the average surgeon very successful in taking care of their patients and driving optimized clinical outcomes.

    是的,我認為這是——我們真正喜歡的是大量真實世界的臨床數據。我們設計我們的產品來幫助——幫助普通外科醫生提供最佳的臨床結果,對嗎?我們還談到了 Omni 的 Ergo 系列。這就是我們的成功。成功是讓普通外科醫生在照顧病人和推動優化臨床結果方面非常成功。

  • So for Sight Sciences, having access to many surgeries from many, many different surgeons as opposed to a very -- there's a benefit to highly controlled clinical trials and RCTs and what not. But there's also something to be said about how does your product and procedure perform across thousands of surgeons and the average surgeon, not just your preferred clinical trial sites. So we're very excited about that. We think that we can't talk about the timing exactly in terms -- it depends on the publication, but it will offer a powerful clinical marketing.

    因此,對於 Sight Sciences 而言,從許多不同的外科醫生那裡獲得許多手術,而不是非常——高度控制的臨床試驗和隨機對照試驗有好處,而沒有。但是,關於您的產品和程序在數千名外科醫生和普通外科醫生中的表現如何,而不僅僅是您首選的臨床試驗地點,還有一些話要說。所以我們對此感到非常興奮。我們認為我們不能確切地談論時間——這取決於出版物,但它將提供強大的臨床營銷。

  • And ultimately, we're seeing and hearing that payors going forward are going to be relying more and more on credible substantial real-world evidence. So we would expect to continue mining Verana real-world data. As we proceed, we expect that it will certainly help in terms of growing our businesses from a clinical marketing perspective and how OMNI compares to other MIGS options. And then ultimately, as payors begin to rely more and more on these large-scale real-world evidence studies, we think that, that can be helpful as well.

    最終,我們看到並聽到付款人未來將越來越依賴可靠的大量現實證據。因此,我們希望繼續挖掘 Verana 真實世界的數據。隨著我們的推進,我們預計它肯定會從臨床營銷的角度幫助我們發展業務,以及 OMNI 與其他 MIGS 選項的比較。然後最終,隨著付款人開始越來越依賴這些大規模的真實世界證據研究,我們認為這也會有所幫助。

  • Operator

    Operator

  • Our next question comes from the line of David Saxon with Needham & Company.

    我們的下一個問題來自 Needham & Company 的 David Saxon。

  • David Joshua Saxon - Senior Analyst

    David Joshua Saxon - Senior Analyst

  • Maybe to start on surgical glaucoma. Of the 200 SION accounts, it looks like you have about 130 that are OMNI accounts so could you talk about what you're seeing from a cannibalization perspective?

    也許開始手術青光眼。在 200 個 SION 賬戶中,您似乎有大約 130 個是 OMNI 賬戶,那麼您能從蠶食的角度談談您所看到的嗎?

  • Tom Huang - Head of Corporate Strategy & Development

    Tom Huang - Head of Corporate Strategy & Development

  • I think we're seeing very little of it based on the -- as Paul said in his remarks, based on the accounts that ordered OMNI in the fourth quarter of 2021 and OMNI and SION in the fourth quarter of 2022. Utilization of OMNI actually increased by 12%. So we are really excited about that. We -- with no cannibalization, you would see flat utilization. The fact that we are actually able to increase utilization and accounts despite adding SION to their portfolio really suggests that we've got a lot of runway here.

    我認為,基於 2021 年第四季度訂購 OMNI 以及 2022 年第四季度訂購 OMNI 和 SION 的賬戶,我們看到的很少——正如保羅在發言中所說的那樣。OMNI 的實際使用增加了 12%。所以我們對此感到非常興奮。我們 - 沒有蠶食,你會看到平坦的利用率。事實上,儘管將 SION 添加到他們的投資組合中,我們實際上能夠提高利用率和賬戶,這確實表明我們在這裡有很多跑道。

  • Paul Badawi - Co-Founder, President, CEO & Director

    Paul Badawi - Co-Founder, President, CEO & Director

  • And just keep in mind that the portfolio allows our reps even more time to be with their surgeon customers in the operating room. And so the -- that opportunity just creates more opportunity for us to educate and train our surgeons on all the good work that we're doing across our portfolio and the increasing body of clinical evidence that we're generating for both OMNI and SION going forward.

    請記住,產品組合讓我們的代表有更多時間在手術室與他們的外科醫生客戶在一起。因此 - 這個機會只是為我們創造了更多機會,讓我們可以就我們在產品組合中所做的所有出色工作以及我們為 OMNI 和 SION 產生的越來越多的臨床證據對我們的外科醫生進行教育和培訓向前。

  • David Joshua Saxon - Senior Analyst

    David Joshua Saxon - Senior Analyst

  • Okay. Yes, that's helpful. And then, I guess, maybe staying on glaucoma. Just can you talk about the pricing trends you're seeing, just given some competitive launches? Are you seeing anyone get more aggressive with pricing or doing anything with bundling?

    好的。是的,這很有幫助。然後,我想,也許會繼續患青光眼。你能談談你看到的定價趨勢嗎,只是給出了一些有競爭力的發布?您是否看到有人在定價或捆綁銷售方面變得更加激進?

  • Tom Huang - Head of Corporate Strategy & Development

    Tom Huang - Head of Corporate Strategy & Development

  • I don't think we've seen much of that in the field yet. Our ASPs have remained steady.

    我認為我們在該領域還沒有看到很多。我們的 ASP 一直保持穩定。

  • Operator

    Operator

  • I'm showing no further questions in the queue. I would now like to turn the call back to Paul for closing remarks.

    我不會在隊列中顯示更多問題。我現在想把電話轉回給保羅,讓他發表結束語。

  • Paul Badawi - Co-Founder, President, CEO & Director

    Paul Badawi - Co-Founder, President, CEO & Director

  • Well, thank you all for your interest in Sight Sciences and have a great day.

    好吧,謝謝大家對視覺科學的興趣,祝你有美好的一天。

  • Operator

    Operator

  • Ladies and gentlemen this concludes today's conference call. Thank you for your participation. You may now disconnect.

    女士們,先生們,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。