Eyenovia Inc (EYEN) 2024 Q3 法說會逐字稿

Greetings, and welcome to the Eyenovia third-quarter 2024 earnings call. (Operator Instructions) As a reminder, this conference is being recorded.

您好，歡迎參加 Eyenovia 2024 年第三季財報電話會議。 （操作員指示）謹此提醒，本次會議正在錄製中。

It is now my pleasure to introduce your host, Eric Ribner from Investor Relations. Thank you. You may begin.

現在我很高興向您介紹主持人，投資者關係部的 Eric Ribner。謝謝。你可以開始了。

Good afternoon, and welcome to Eyenovia's Third Quarter 2024 Earnings Conference Call and Audio Webcast. With me today are Eyenovia's Chief Executive Officer, Michael Rowe; Chief Operating Officer, Bren Kern; and newly appointed Chief Financial Officer, Andy Jones. Welcome, everybody. This afternoon, we issued a press release announcing financial results for the 3 months ended September 30, 2024. We encourage everyone to read today's press release as well as Eyenovia's quarterly report on Form 10-Q for the second quarter ended September 30, 2024, which was just filed with the SEC. The company's press release and annual report are also available on our website at www.eyenovia.com. In addition, this conference call is being webcast on the company's website and will be archived and available for replay for future reference. Please note that on today's call, we will be discussing products, product concepts and candidates, some of which have yet to receive FDA approval. Please also note that certain information discussed on the call today is covered under the safe harbor provision of the Private Securities Litigation Reform Act. We caution listeners that during the call, Eyenovia's management will be making forward-looking statements. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are subject to a number of risks, which are described in more detail on our annual report on Form 10-K and subsequently -- subsequent quarterly reports on Form 10-Q. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, November 12, 2024. Eyenovia undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as may be required by the applicable securities law. With that said, I'd like to turn the call over to Michael Rowe, Eyenovia's Chief Executive Officer. Michael, the floor is yours.

下午好，歡迎參加 Eyenovia 2024 年第三季財報電話會議和音訊網路廣播。今天與我在一起的有 Eyenovia 執行長 Michael Rowe；營運長布倫·科恩；以及新任命的財務長安迪瓊斯。歡迎大家。今天下午，我們發布了一份新聞稿，公佈了截至2024 年9 月30 日的三個月的財務業績。 10-Q 表格季度報告，該文件剛剛向 SEC 提交。該公司的新聞稿和年度報告也可在我們的網站 www.eyenovia.com 上取得。此外，本次電話會議正在公司網站上進行網路直播，並將存檔並可供重播以供日後參考。請注意，在今天的電話會議上，我們將討論產品、產品概念和候選產品，其中一些尚未獲得 FDA 批准。另請注意，今天電話會議中討論的某些資訊受《私人證券訴訟改革法案》的安全港條款管轄。我們提醒聽眾，在電話會議期間，Eyenovia 的管理層將做出前瞻性聲明。由於與公司業務相關的風險和不確定性，實際結果可能與這些前瞻性陳述中明示或暗示的結果有重大差異。這些前瞻性陳述面臨許多風險，這些風險在我們的 10-K 表年度報告以及隨後的 10-Q 表格季度報告中進行了更詳細的描述。本次電話會議所包含的時間敏感資訊僅截至本次直播之日（2024 年 11 月 12 日）準確。適用的證券法有要求。話雖如此，我想將電話轉給 Eyenovia 執行長 Michael Rowe。邁克爾，地板是你的。

Thank you, Eric, and welcome, everyone, to our third quarter 2024 financial results conference call. During the third quarter, we made significant progress towards transforming Eyenovia into a leader in improving outcomes from topical ophthalmic medications built around our Optejet technology. First and most near-term, we are rapidly approaching a potential Phase III efficacy data readout for MicroPine, our pediatric progressive myopia product, which, if approved, provides entry to a multibillion-dollar addressable market opportunity. Second, we are making advances with our next-generation Optejet technology and are excited about the progress and what this will mean for our profitability profile. Third, we have been commercializing our mydriasis product, MydCombi, the first FDA-approved product based on Optejet technology, and we also launched our second FDA-approved product, clobetasol, an advanced ophthalmic steroid with a highly desirable profile. Fourth, we are advancing our Optejet development pipeline in dry eye with clobetasol serving as the cornerstone for 3 compounds in late-stage development and partially funded through our strategic partners. Now let's take a deeper dive into MicroPine, our Optejet-based low-dose atropine product candidate for pediatric progressive myopia. Pediatric progressive myopia is increasingly recognized as an epidemic in both the United States and globally. In the U.S. alone, of the nearly 20 million children with myopia, approximately 5 million are considered at risk of losing functional vision due to this disease. While glasses and contact lenses are the current standard of care for children diagnosed with progressive myopia, they are not always appropriate for the youngest children, who are also at the most risk of [ myopia ] progression. Many younger children do not tolerate contact lenses well, have difficulty putting something on their eye or may cause themselves injury or illness due to poor lens insertion techniques. Atropine has been shown in prior studies such as LAMP and ATOM to slow myopia progression, and we believe our proprietary atropine formulation administered with the Optejet may offer benefits beyond what could be obtained with a traditional eye drop. With the Optejet technology, children in our Phase III CHAPERONE study as young as 6 years old are dosing themselves nightly with minimal parental supervision. They can self-administer the dose because the Optejet doesn't require any head tilting or manipulation of an eye drop or bottle, making aiming with a built-in mirror and medication administration achievable. The dosing itself feels like a gentle mist and children have become familiar and comfortable with the dosing process quickly. This has the potential to reduce dosing anxiety and minimizes the myriad of struggles parents face when dosing children with conventional eye drops. The side effects of atropine dosed with the Optejet have been notably infrequent and mild in the CHAPERONE study. These results are consistent with what we have come to expect with our advanced drug device dosing system. Throughout the trial, our engineers have been keeping track of the performance of the Optejet with embedded firmware that also helps study doctors to better understand how and when the device has been used. Each time the dosing button is pressed to administer medication, the device records the event and stores the information. This information can be accessed and reviewed by clinic staff during the patient visit. For the commercial product, we anticipate MicroPine will be equipped with our OptiCare system, which can notify patients and their parents and their caregivers when to administer their spray dose as well as communicate important compliance and adherence information for the treating doctor. Our engineers are working today on plans to validate the system as part of our anticipated future NDA submission. We are continuing to advance the Phase III CHAPERONE study and are looking forward to the outcome of an analysis of the 3 year efficacy and safety data very soon. If this analysis conducted by an independent data review committee indicates that we have likely achieved our efficacy endpoint, we would perform a complete analysis and discuss with the FDA an accelerated pathway towards an NDA submission as soon as early 2026. We look forward to providing additional updates on this program during our upcoming KOL virtual event on December 11. Now let's talk about the advances our team has made with our Gen 2 Optejet. We recently completed the first phase of manufacturing registration batches and are now preparing those cartridges for sterilization and subsequent drug stability testing. This is a key step in the FDA review process for this technology. We are leading with MydCombi as this is our most expeditious path to registration, and we believe would provide a foundation for all subsequent products that are developed for use with the Optejet. As a reminder, the Gen 2 device has many advancements over its first-generation predecessor, including one button use and compatibility with our digital compliance monitoring program, OptiCare. It was also developed with fewer parts and is more efficient to manufacture. This greater efficiency translates to lower costs, helping us to achieve margins of up to 90% on our planned product line. We view the introduction of the Gen 2 Optejet as a significant upcoming inflection point for the company. Now let's look more deeply into MydCombi. MydCombi is also very important to Eyenovia as it has derisked our Optejet technology from a regulatory point of view. Prior to the approval of MydCombi, there were no other products in ophthalmology that combine the approval of a drug with a device containing electronics. We worked very closely with the FDA to identify the various activities, studies and validation processes necessary to get our device approved, allowing MydCombi to serve as the precedent for any other Optejet-based product. Obtaining FDA approval by itself was a terrific milestone for our company, and we are now recognized as a leader of this technology within eye care. We also understand that introducing this technology into the market requires us the paradigm of using eye drops. With this in mind, we placed MydCombi in about 200 offices and work closely with those doctors and their technicians to learn more about their perceptions of the Optejet platform. We found that after using MydCombi 50 times, which translates to about a week, both doctors and technicians felt truly comfortable with the change from eye drops. We also found that 4 out of 5 eye care professionals felt that MydCombi was a substantial improvement over eye drops, especially when dilating older people, children and those who needed to return to work more quickly as their experience with MydCombi was that pupil dilation did not last as long as it did with eye drops, which was highly desirable. As a result of these positive findings, our sales force is now focused on 3 things: formulary acceptance of key institutions, retention of the existing offices and converting another 200 offices over the next few months, which they are working on right now. Before turning the call over to Bren, I'd like to cover a recent change to our Board of Directors. In September, our Founder and Board member, Sean Ianchulev, stepped down from the Chairman role for personal reasons. He will remain on the Board and also continue to serve as our Executive Medical Consultant. Charles Mather, who has served on our Board since 2018, has been appointed our new Chairman. Charlie has significant experience and expertise in capital markets, and his guidance has served us well as we work to keep the company sufficiently funded to advance our development initiatives. We are pleased that we will continue to have both Charlie and Sean as vital resources on our Board at this important time for Eyenovia. At this point, I'll turn the call over to our Chief Operating Officer, Bren Kern. Bren?

謝謝艾瑞克，歡迎大家參加我們的 2024 年第三季財務業績電話會議。第三季度，我們在將 Eyenovia 轉變為改善基於 Optejet 技術的局部眼科藥物治療效果的領導者方面取得了重大進展。首先，也是最近一段時間，我們正在迅速接近我們的兒科漸進性近視產品 MicroPine 的潛在 III 期療效數據讀數，如果獲得批准，將提供進入數十億美元可尋址市場機會的機會。其次，我們正在利用下一代 Optejet 技術取得進展，並對這一進展以及這對我們的獲利狀況意味著什麼感到興奮。第三，我們已經將我們的散瞳產品MydCombi 商業化，這是第一個FDA 批准的基於Optejet 技術的產品，我們還推出了我們的第二個FDA 批准的產品氯倍他索，這是一種具有非常理想的特性的先進眼科類固醇。第四，我們正在推進乾眼領域的 Optejet 開發管線，以氯倍他索作為 3 種處於後期開發階段的化合物的基石，並透過我們的策略合作夥伴提供部分資金。現在讓我們更深入了解 MicroPine，這是我們基於 Optejet 的低劑量阿托品候選產品，用於治療兒童進行性近視。在美國和全球範圍內，兒童漸進性近視越來越被認為是一種流行病。光是在美國，就有近 2,000 萬近視兒童，其中約 500 萬人被認為面臨因這種疾病而喪失功能性視力的風險。雖然眼鏡和隱形眼鏡是目前診斷患有進行性近視的兒童的標準護理，但它們並不總是適合最小的兒童，因為他們也是[近視]進展的風險最大的人。許多年幼的孩子無法很好地耐受隱形眼鏡，難以將東西戴在眼睛上，或者可能由於不良的鏡片插入技術而導致自己受傷或生病。先前的 LAMP 和 ATOM 等研究表明阿托品可以減緩近視進展，我們相信與 Optejet 一起使用的專有阿托品配方可能會提供超越傳統滴眼液所能獲得的益處。借助 Optejet 技術，我們的 III 期 CHAPERONE 研究中年僅 6 歲的兒童可以在父母最少監督的情況下每晚自行服藥。他們可以自行給藥，因為 Optejet 不需要任何頭部傾斜或操作滴眼劑或瓶子，從而可以透過內置鏡子進行瞄準和給藥。給藥本身感覺就像是輕柔的薄霧，孩子們很快就熟悉並適應了給藥過程。這有可能減少用藥焦慮，並最大限度地減少父母在給孩子使用傳統眼藥水時面臨的無數困難。在 CHAPERONE 研究中，使用 Optejet 服用阿托品的副作用非常罕見且輕微。這些結果與我們對先進藥物裝置劑量系統的預期一致。在整個試驗過程中，我們的工程師一直在追蹤帶有嵌入式韌體的 Optejet 的性能，這也有助於研究醫生更好地了解該設備的使用方式和時間。每次按下給藥按鈕進行給藥時，設備都會記錄該事件並儲存資訊。診所工作人員可以在患者就診期間訪問和查看這些資訊。對於商業產品，我們預計 MicroPine 將配備我們的 OptiCare 系統，可告知患者及其父母和照護者何時施用噴霧劑量，並向治療醫生傳達重要的依從性和依從性訊息。我們的工程師今天正在製定驗證系統的計劃，作為我們預期的未來 NDA 提交的一部分。我們正在繼續推進 III 期 CHAPERONE 研究，並期待很快獲得 3 年療效和安全性數據的分析結果。如果獨立數據審查委員會進行的這項分析表明我們可能已經達到了療效終點，我們將進行完整的分析，並與 FDA 討論最快於 2026 年初提交 NDA 的加速途徑。 12 月11 日即將舉行的KOL 虛擬活動中介紹該計劃的最新情況。我們最近完成了第一階段的生產註冊批次，現在正在準備這些藥筒進行滅菌和隨後的藥物穩定性測試。這是 FDA 對該技術的審查過程中的關鍵一步。我們以 MydCombi 為主導，因為這是我們最快捷的註冊途徑，我們相信將為與 Optejet 一起使用而開發的所有後續產品奠定基礎。提醒一下，第二代設備比第一代前代設備有許多進步，包括一鍵使用以及與我們的數位合規性監控程式 OptiCare 的兼容性。它的開發部件更少，製造效率更高。更高的效率意味著更低的成本，幫助我們在計畫的產品線上實現高達 90% 的利潤。我們認為第二代 Optejet 的推出是公司即將到來的重要轉捩點。現在讓我們更深入地了解 MydCombi。 MydCombi 對 Eyenovia 也非常重要，因為從監管角度來看，它消除了我們的 Optejet 技術的風險。在 MydCombi 獲得批准之前，眼科領域還沒有其他產品將藥物批准與包含電子設備的設備結合。我們與 FDA 密切合作，以確定我們的設備獲得批准所需的各種活動、研究和驗證流程，從而使 My​​dCombi 成為任何其他基於 Optejet 的產品的先例。獲得 FDA 批准本身對我們公司來說是一個了不起的里程碑，我們現在被公認為眼科護理領域這項技術的領導者。我們也明白，將這項技術引入市場需要我們使用眼藥水的範例。考慮到這一點，我們在大約 200 個辦公室安置了 MydCombi，並與這些醫生及其技術人員密切合作，以了解更多關於他們對 Optejet 平台的看法。我們發現，在使用 MydCombi 50 次（大約一周）後，醫生和技術人員都對滴眼液的改變感到非常滿意。我們還發現，五分之四的眼保健專業人士認為MydCombi 比滴眼液有顯著改善，尤其是在為老年人、兒童和需要更快返回工作崗位的人散瞳時，因為他們使用MydCombi 的經驗是，瞳孔擴張並沒有改善。由於這些積極的發現，我們的銷售團隊現在專注於三件事：對關鍵機構的正式接受、保留現有辦事處以及在未來幾個月內改造另外200 個辦事處，他們目前正在致力於這些工作。在將電話轉給布倫之前，我想先介紹一下我們董事會最近的變動。 9 月，我們的創辦人兼董事會成員 Sean Ianchulev 因個人原因辭去了董事長職務。他將繼續留在董事會，並繼續擔任我們的執行醫療顧問。自 2018 年以來一直在我們董事會任職的查爾斯·馬瑟 (Charles Mather) 已被任命為我們的新董事長。查理在資本市場方面擁有豐富的經驗和專業知識，他的指導對我們很有幫助，我們努力維持公司有足夠的資金來推進我們的發展計畫。我們很高興在 Eyenovia 的這個重要時刻，我們將繼續讓 Charlie 和 Sean 作為我們董事會的重要資源。此時，我會將電話轉給我們的營運長 Bren Kern。布倫？

Thanks, Michael. At the end of September, we announced the launch and commercial availability of clobetasol developed by our partner, Formosa Pharmaceuticals. Clobetasol is FDA approved for the treatment of pain and inflammation following ocular surgery and the first new ophthalmic steroid to come to market in over 15 years. With its favorable efficacy and safety profile, convenient twice-a-day dosing regimen, and streamlined distribution designed to eliminate complications from insurance, we're seeing strong interest amongst doctors and have already placed clobetasol into local pharmacies supporting over 100 offices. Clobetasol perfectly complements MydCombi, our FDA-approved and commercially available mydriasis agents, offering additional value to ophthalmic offices while maximizing the utilization of our 10 person sales force. Offices commonly show interest in both clobetasol and MydCombi. The launch of clobetasol signifies a substantial step towards the execution of our commercial strategy. We also announced the results of commission market research indicating strong level of interest from ophthalmic surgeons after their review of prescribing information. 100 ophthalmic surgeons were involved in this research and ranked efficiency and safety as the most important characteristics of post-operative steroids. In clinical studies of clobetasol, approximately 80% of patients had complete relief from pain as soon as 4 days post surgery versus approximately 50% for patients who had vehicle. Clobetasol safety information was also of importance with the same study results showing that no single adverse event affected more than 2% of patients. These top 2 characteristics piqued the surgeons interest. The research also showed that managed care coverage challenges were a significant concern for most of the doctors. Eyenovia is addressing these concerns by offering clobetasol to patients at a low fixed price regardless of their insurance status. This is seen by surgeons as a great way to eliminate insurance complications that often burden their office staff. In summary, the majority of surgeons surveyed based solely on the actual prescribing information and pricing indicate a high level of interest in prescribing clobetasol. Turning now to our manufacturing facilities. Recently, we successfully completed 2 audits of Reno, Nevada facility, one by the Nevada Board of Pharmacy and the second by the FDA. Receipt of these licenses enabled Eyenovia to manufacture, store, transport and distribute our products, another significant step in transitioning Eyenovia to a commercial company. I'd now like to switch gears with an update on our partnerships, beginning with dry eye. Recall in our last quarterly update, we discussed 3 development collaboration agreements each -- with each drug being a primary candidate to leverage our Optejet dispenser. Nearly 16 million Americans suffered from dry eye with treatment expenditures totaling over $3 billion in the U.S. and $5 billion globally. Symptoms of dry eye can significantly interfere with daily life and many patients remain unsatisfied with available therapies. According to our recent survey by the American Academy of Ophthalmology, 48% of patients reported carefully following their treatment plans, but only 13% experienced lasting relief. We're excited about our collaboration agreements in the field of dry eye. In brief recap for Formosa, we signed an agreement to develop a formulation of clobetasol in the Optejet as a potential treatment for acute dry eye and in other indications. This development program, which will require 2 15 day clinical trials, will be free of any upfront fees from Eyenovia or development milestones to Formosa in less and until it receives FDA approval. For Senju Pharmaceuticals, we also signed a collaboration agreement to develop a new adjunctive treatment for chronic dry eye disease. We will work closely to develop Senju's SJP-0035, initially intended to facilitate epithelial wound healing as a candidate for use with the Optejet to treat chronic dry eye. This potential drug device combination is unique as it is being designed for use alongside other dry eye medications. In other words, we believe it would be -- it would complement existing products rather than competing with them. We are working towards requesting a meeting with the FDA later this year, followed by anticipated completion of a Phase IIb study in 2025. If successful, the companies may expand this collaboration and initiate 2 Phase III studies by 2026. To date, SJP-0035 has been tested in prior Phase I and Phase II studies as a standard eye drop across 250 subjects at multiple doses. With these studies, SJP-0035 was well tolerated, providing promise to support chronic dry eye indication. And finally, SGN. We entered into a collaboration agreement with SGN Nanopharma to leverage its proprietary myocellular nanoparticle platform known as the MNP platform. This platform allows for the distribution of active pharmaceutical ingredient in 3 or more phases, thereby improving its bioavailability, biodistribution and pharmacokinetics. We have been conducting feasibility and manufacturing testing with SGN's Phase III-ready ophthalmic cyclosporine formulation, SGN-101, in combination with our Optejet device as a potential treatment for chronic dry eye. This faster working cyclosporine, combined with the Optejet dispenser to be a powerful new treatment option for this large underserved market. With the SGN collaboration, we are hopeful that we may have a Phase III-ready asset next year in chronic dry eye. With these 3 agreements, we have the potential to make strong inroads into the entire dry eye market, a $3 billion annual addressable U.S. market serving a multimillion patient population with unmet needs. I'll now provide an update on our existing licensing program with Arctic Vision, which covers all 3 of our products, MicroPine, Apersure and MydCombi in China and South Korea. This licensing program provides for sales royalties in addition to development milestones. As Michael said earlier, MicroPine, in particular, is a significant opportunity in China for pediatric myopia and part of the $5 billion global market. If approved, MicroPine could be a potentially meaningful source of long-term nondilutive funding for the company. To date, our licensing agreement with Arctic Vision has generated approximately $6 million in licensing fees, and we have the potential to earn an additional $37 million in net license and development milestones over the next 3 to 6 years. If our products are approved upon commercialization, we'd also be eligible to earn significant sales royalties. We are excited about the improvements the Optejet may provide for patients required to deliver topical ophthalmic medications and believe this platform has widespread utility. To that end, we continue to assess our potential pipeline expansion opportunities. Similar to Formosa, Senju and SGN, we are seeking opportunities which can leverage the Optejet technology in additional large ophthalmic indications such as glaucoma. I'd now like to turn the call over to our new Chief Financial Officer, Andy Jones. Andy?

謝謝，麥可。 9月底，我們宣布由我們的合作夥伴台塑製藥開發的氯倍他索上市並商業化。氯倍他索經 FDA 批准用於治療眼科手術後的疼痛和炎症，也是 15 年來第一個上市的新型眼科類固醇。憑藉其良好的功效和安全性、方便的每日兩次給藥方案以及旨在消除保險並發症的簡化分銷，我們看到了醫生的濃厚興趣，並已將氯倍他索投放到當地藥房，為100 多個辦事處提供支援。氯倍他索完美補充了 MydCombi（我們經 FDA 批准的市售散瞳劑），為眼科診所提供額外價值，同時最大限度地利用我們 10 人的銷售隊伍。各辦公室普遍對氯倍他索和 MydCombi 表現出興趣。氯倍他索的上市標誌著我們向執行商業策略邁出了實質的一步。我們也公佈了委託市場研究的結果，顯示眼科醫生在審查處方資訊後表現出了濃厚的興趣。 100 名眼外科醫生參與了這項研究，並將效率和安全性列為術後類固醇最重要的特徵。在氯倍他索的臨床研究中，約 80% 的患者在術後 4 天後疼痛完全緩解，而使用賦形劑的患者中這一比例約為 50%。氯倍他索的安全性資訊也很重要，同一研究結果顯示，沒有單一不良事件影響超過 2% 的患者。這兩個最重要的特徵引起了外科醫生的興趣。研究還表明，管理式醫療保險覆蓋範圍的挑戰是大多數醫生最關心的問題。 Eyenovia 正在透過以較低的固定價格向患者提供氯倍他索來解決這些問題，無論他們的保險狀況如何。外科醫生認為這是消除保險併發症的好方法，這些併發症經常給辦公室工作人員帶來負擔。總而言之，僅根據實際處方資訊和定價進行調查的大多數外科醫生表明對開氯倍他索處方有很高的興趣。現在轉向我們的生產設施。最近，我們成功完成了內華達州里諾工廠的兩次審核，一次由內華達州藥房委員會審核，第二次由 FDA 審核。獲得這些許可證使 Eyenovia 能夠製造、儲存、運輸和分銷我們的產品，這是 Eyenovia 向商業公司轉型的又一個重要步驟。我現在想換個話題，從乾眼症開始，介紹一下我們的合作關係的最新情況。回想一下，在上一季更新中，我們討論了 3 項開發合作協議，每種藥物都是利用我們 Optejet 分配器的主要候選藥物。近 1,600 萬美國人患有乾眼症，美國的治療費用總計超過 30 億美元，全球治療費用總計超過 50 億美元。乾眼症狀會嚴重干擾日常生活，許多患者對現有的治療方法仍然不滿意。根據美國眼科學會最近的調查，48% 的患者表示認真遵循了治療計劃，但只有 13% 的患者獲得了持久的緩解。我們對乾眼領域的合作協議感到非常興奮。簡而言之，我們簽署了一項協議，在 Optejet 中開發氯倍他索配方，作為急性乾眼症和其他適應症的潛在治療方法。該開發計劃需要 2 個 15 天的臨床試驗，在獲得 FDA 批准之前，Eyenovia 或 Formosa 的開發里程碑將免收任何前期費用。對於千住製藥，我們還簽署了一項合作協議，開發一種針對慢性乾眼症的新輔助治療方法。我們將密切合作開發 Senju 的 SJP-0035，最初旨在促進上皮傷口癒合，作為與 Optejet 一起使用治療慢性乾眼症的候選藥物。這種潛在的藥物裝置組合是獨一無二的，因為它被設計為與其他乾眼藥物一起使用。換句話說，我們相信它將是現有產品的補充，而不是與它們競爭。我們正在努力要求在今年稍後與FDA 舉行會議，預計在2025 年完成IIb 期研究。 ，SJP-0035已在先前的 I 期和 II 期研究中作為標準滴眼劑在 250 名受試者中以多種劑量進行了測試。透過這些研究，SJP-0035 具有良好的耐受性，為支持慢性乾眼症提供了希望。最後，SGN。我們與 SGN Nanopharma 簽訂了合作協議，利用其專有的肌肉細胞奈米顆粒平台（稱為 MNP 平台）。該平台允許活性藥物成分在3個或更多個階段中分佈，從而提高其生物利用度、生物分佈和藥物動力學。我們一直在使用 SGN 的 III 期眼科環孢菌素製劑 SGN-101 與我們的 Optejet 設備結合作為慢性乾眼症的潛在治療方法進行可行性和製造測試。這種起效更快的環孢菌素與 Optejet 分配器相結合，成為這個服務不足的大型市場的強大新治療選擇。透過與 SGN 的合作，我們希望明年能夠擁有針對慢性乾眼症的 III 期資產。憑藉這 3 項協議，我們有潛力大力進軍整個乾眼市場，這是一個每年價值 30 億美元的美國市場，為數百萬需求未滿足的患者群體提供服務。我現在將提供有關 Arctic Vision 的現有許可計劃的最新信息，該計劃涵蓋了我們在中國和韓國的所有 3 個產品：MicroPine、Apersure 和 MydCombi。除了開發里程碑之外，該許可計劃還提供銷售特許權使用費。正如 Michael 之前所說，MicroPine 對於中國兒童近視患者以及價值 50 億美元的全球市場來說是一個重大機會。如果獲得批准，MicroPine 可能成為該公司長期非稀釋資金的潛在有意義的來源。迄今為止，我們與 Arctic Vision 的授權協議已產生約 600 萬美元的授權費，並且我們有潛力在未來 3 至 6 年內額外賺取 3,700 萬美元的淨許可和開發里程碑。如果我們的產品在商業化後獲得批准，我們還有資格獲得可觀的銷售特許權使用費。我們對 Optejet 可能為需要輸送局部眼科藥物的患者提供的改進感到興奮，並相信該平台具有廣泛的實用性。為此，我們將繼續評估潛在的管道擴張機會。與 Formosa、Senju 和 SGN 類似，我們正在尋找機會，利用 Optejet 技術治療青光眼等其他大型眼科適應症。我現在想將電話轉給我們新任財務長安迪瓊斯。安迪？

Thanks, Bren. I'm very excited to be here with everyone today as part of the Eyenovia team. For the third quarter of 2024, we reported a net loss of approximately $7.9 million or $0.11 per share on approximately 69.5 million weighted average shares outstanding. This compares to a net loss of $7.3 million or $0.18 per share and approximately 40.1 million weighted average shares outstanding for the third quarter of 2023. Gross loss for the third quarter was $131,000, which compares to $12,000 for the prior year quarter. The losses are primarily the result of adjustments to write down inventory to net realizable value during the respective periods related to MydCombi and our Gen 1 device. We will likely continue to incur such losses on sales of our Gen 1 device. However, we anticipate that positive margins on clobetasol sales will offset those losses as that channel grows. Research and development expenses totaled approximately $3.5 million for the third quarter of 2024, and this compares to $3.6 million for the third quarter of 2023, a slight decrease, which reflects the reallocation of internal resources to commercial production. For the third quarter of 2024, general and administrative expenses were approximately $3.7 million as compared to $2.9 million for the third quarter of 2023, and that's an increase of 27.3%. That increase consisted primarily of $647,000 in salaries and benefits, primarily related to the start of the company's commercialization efforts. Total operating expenses for the third quarter of 2024 were approximately $7.2 million as compared to $6.5 million for the same period in 2023. This represents an increase of approximately 10.6%. Our third quarter 2024 operating expense figure also included approximately $1.2 million of non-cash expenses. At September 30, 2024, we reported unrestricted cash of approximately $7.2 million, this includes net proceeds of approximately $10.7 million raised during the quarter through securities offerings. We continue to evaluate capital raising structures to fund our ongoing strategy and to make near-term payments on our Avenue loan. Also, as always, we continue to look at ways to improve our operating efficiencies and control expenses. We are excited about our commercial portfolio, our development pipeline and our current and future partnerships that leverage the Optejet platform. We believe that we have established a foundation for growth as a leading ophthalmic company with a novel and highly differentiated technology and applications across several very large market ophthalmic indications. In conclusion, we are very pleased with our progress in the third quarter of 2024 and expectations for subsequent periods. To summarize our key highlights today, first, we are preparing for an analysis of the 3 year efficacy data from our ongoing Phase III CHAPERONE trial of MicroPine in pediatric progressive myopia this quarter. If positive, this data may allow us to significantly advance our remaining development time line. Also, we commenced the manufacture of registration batches of MydCombi and our state-of-the-art Gen 2 Optejet device. We also announced the U.S. launch and commercial availability of clobetasol, which is the first new ocular steroid approved in more than 15 years. Customer feedback has been very positive, and we are very excited about the opportunity here. With over 6 million surgeries performed each year in the U.S. for which patients could potentially benefit from clobetasol, we believe that even a low single-digit market share would be very meaningful for us. We entered into development collaborations with Formosa, Senju and SGN to develop novel therapeutic formulations for the Optejet that would potentially address unmet needs in acute and chronic dry eye disease. Also, our commercial launch of MydCombi continues to track well with the product now in use at over 200 ophthalmology offices around the country. And finally, our licensing agreement with Arctic Vision is progressing well and remains a promising avenue for significant development and regulatory milestones as well as the potential for sales royalties. This concludes our prepared remarks. We would now like to open the call to questions. Operator?

謝謝，布倫。我很高興今天能作為 Eyenovia 團隊的一員與大家在一起。 2024 年第三季度，我們報告約 6,950 萬股加權平均已發行股票的淨虧損約為 790 萬美元，即每股 0.11 美元。相較之下，2023 年第三季的淨虧損為730 萬美元，即每股0.18 美元，加權平均已發行股票約為4,010 萬股。美元。損失主要是由於在 MydCombi 和我們的第一代設備相關期間將庫存減記至可變現淨值而進行的調整。我們的第一代設備的銷售可能會繼續遭受此類損失。然而，我們預計，隨著該通路的成長，氯倍他索銷售的正利潤率將抵消這些損失。 2024年第三季的研發費用總計約為350萬美元，與2023年第三季的360萬美元相比略有下降，這反映出內部資源重新分配到商業生產。 2024 年第三季的一般及管理費用約為 370 萬美元，而 2023 年第三季為 290 萬美元，成長了 27.3%。這一增長主要包括 647,000 美元的工資和福利，主要與公司商業化工作的啟動有關。 2024 年第三季的總營運費用約為 720 萬美元，而 2023 年同期為 650 萬美元。我們的 2024 年第三季營運支出數據還包括約 120 萬美元的非現金支出。截至 2024 年 9 月 30 日，我們報告的不受限制的現金約為 720 萬美元，其中包括本季透過證券發行籌集的約 1,070 萬美元的淨收益。我們將繼續評估融資結構，為我們正在進行的策略提供資金，並支付我們的大道貸款的短期付款。此外，一如既往，我們繼續尋找提高營運效率和控制費用的方法。我們對利用 Optejet 平台的商業產品組合、開發管道以及當前和未來的合作夥伴關係感到興奮。我們相信，我們已經為作為一家領先的眼科公司的發展奠定了基礎，在多個非常大的眼科適應症市場上擁有新穎且高度差異化的技術和應用。總之，我們對 2024 年第三季的進展以及對後續時期的期望感到非常滿意。總結我們今天的主要亮點，首先，我們正在準備對本季正在進行的 MicroPine 治療兒童進行性近視的 III 期 CHAPERONE 試驗的 3 年療效數據進行分析。如果是正面的，這些數據可能會讓我們顯著提前剩餘的開發時間。此外，我們也開始生產註冊批次的 MydCombi 和最先進的 Gen 2 Optejet 設備。我們也宣佈在美國推出並商業化氯倍他索，這是 15 年來第一個獲得批准的新型眼部類固醇。客戶的回饋非常積極，我們對這裡的機會感到非常興奮。美國每年進行超過 600 萬例手術，患者可能從氯倍他索中受益，我們相信，即使是低個位數的市場份額對我們來說也非常有意義。我們與 Formosa、Senju 和 SGN 進行開發合作，為 Optejet 開發新型治療配方，這可能會解決急性和慢性乾眼症未滿足的需求。此外，我們的 MydCombi 商業推出繼續順利進行，該產品目前在全國 200 多個眼科診所使用。最後，我們與 Arctic Vision 的授權協議進展順利，並且仍然是實現重大開發和監管里程碑以及銷售特許權使用費潛力的有希望的途徑。我們準備好的演講到此結束。我們現在要開始提問。操作員？

[Operator Instructions] The first question is from Matthew Caufield from H.C. Wainwright.

[操作員說明] 第一個問題來自 H.C. 的 Matthew Caufield。溫賴特。

So as we look to the CHAPERONE trial, what are the most important distinctions for setting expectations to define success? Obviously, we're looking at the myopia progression of less than 0.5 diopters. But are there other top points that are most clinically meaningful or relevant as we get closer to that readout?

因此，當我們展望 CHAPERONE 試驗時，設定期望以定義成功的最重要差異是什麼？顯然，我們關注的是小於 0.5 屈光度的近視進展。但是，當我們接近讀數時，是否還有其他最具臨床意義或相關性的要點？

Thank you, Matt, and it's a very good question. So the way this is going to work is that the independent review committee, which is truly independent of us and is made up of expert medical doctors and optometrists in the field, they're going to, after they meet, tell us whether or not at least one of the doses in the CHAPERONE study appears to have reached statistical significance over placebo. Once that happens, then our company, Eyenovia will make a decision to open the database and dive into the data, which will take a few days more to see exactly what's going on. Things that we will be looking for, obviously, is the efficacy endpoint that you talked about, which is the number of -- or a portion of patients that do not progress more than 0.5 diopter after 3 years of therapy. But in addition to that, the things I would like to look at are the things that make the Optejet very special. And those would be things like the side effect profile, where we anticipate because we're in ophthalmic spray that we should be more comfortable than would be expected from an eye drop or things later on about compliance, where we would want to see that the children in the study were able to comply with therapy more than what you have seen in historical studies that are similar. Another one we'd be looking at is there has to be a PK or blood level evaluation as well. And we'd like to see that there's very little exposure systemically to atropine during the study, too, which could be another advantage. So those are the types of things that differentiate the Optejet delivered product versus perhaps an eye drop that we want to look at.

謝謝你，馬特，這是一個非常好的問題。因此，運作方式是獨立審查委員會，它真正獨立於我們，由該領域的專家醫生和驗光師組成，他們將在開會後告訴我們是否CHAPERONE 研究中至少有一種劑量似乎比安慰劑達到了統計學顯著性。一旦發生這種情況，我們公司 Eyenovia 將決定打開資料庫並深入研究數據，這將需要幾天的時間才能確切地了解發生了什麼。顯然，我們要尋找的是您談到的療效終點，即經過 3 年治療後屈光度進展不超過 0.5 的患者數量或一部分。但除此之外，我還想看看 Optejet 的特別之處。這些將是諸如副作用概況之類的事情，我們預計因為我們使用的是眼科噴霧劑，所以我們應該比滴眼劑或稍後有關依從性的事情預期更舒服，我們希望看到研究中的兒童比歷史上類似的研究中所看到的更能遵守治療。我們要考慮的另一個問題是還必須進行 PK 或血液水平評估。我們希望看到在研究過程中全身接觸阿托品的情況也很少，這可能是另一個優點。因此，這些就是 Optejet 交付的產品與我們想要查看的眼藥水的區別所在。

Very helpful. And then do you mind if I ask just one quick follow-up on CHAPERONE as well?

非常有幫助。那麼您介意我也問一下關於 CHAPERONE 的一個快速跟進嗎？

Sure.

當然。

So with that trial dosing as young as 6 years old, which you mentioned, is there a sense of what age range progressive myopia is most commonly identified in practice? Like presumably, children are identified a little bit earlier than that. Is that accurate or...

那麼，您提到的試驗用藥年齡為 6 歲，那麼在實務中，是否知道哪個年齡層的漸進性近視最常見？據推測，兒童的識別時間要早一些。這是準確的還是...

Right. So there's actually a number of publications in the area. And one of the things that we've been told is that the way that these children are identified is you have a child coming in usually when they're in kindergarten when they first get their eyes examined. So they're 5 years old, 6 years old, they come in, they're myopic, the doctor looks around, both parents are myopic. That's usually a very good signal that there's probably a genetic component and they're at the most risk. And you want to capture them when they're 5, 6, 7, 8 years old because the progression of myopia is tied to the development of the eye. So the faster and more the eye is developing when the children are younger is when you have greatest progression. By the time you get to somebody who's maybe 14 or 15, you've already kind of lost a lot of that opportunity. So the goal is to find them and find them early.

正確的。所以該領域實際上有很多出版物。我們被告知的一件事是，識別這些孩子的方式是，通常當孩子在幼兒園時第一次檢查眼睛時，他們就會進來。所以他們5歲，6歲，他們進來，他們近視，醫生環顧四周，父母都是近視。這通常是一個非常好的訊號，表示可能存在遺傳成分，而且他們面臨的風險最大。你想在他們 5、6、7、8 歲時捕捉他們，因為近視的進展與眼睛的發育有關。因此，當孩子還小的時候，眼睛發育得越快、越多，進步也越大。當你遇到一個 14 或 15 歲的人時，你已經失去了很多機會。所以我們的目標是找到他們，並且儘早找到他們。

The next question is from Matt Kaplan from Ladenburg Thalmann.

下一個問題來自 Ladenburg Thalmann 的 Matt Kaplan。

Just a follow-up on the CHAPERONE interim analysis. What's the potential powering that you'll have with this interim analysis as you go into it?

只是 CHAPERONE 中期分析的後續行動。當您進入這個中期分析時，您將獲得什麼潛在的動力？

Thanks, Matt, and always good to hear from you as well. I wish I had the statistician here. I believe the power calculation was something around 85% with what we have, and that's at a p-value of less than 021. If I'm off by a little bit, please don't hold me to that because I'm trying to remember what was in the statistical plan. But it's adequately powered at this point, and that's why we're having the independent review committee take a look at the data.

謝謝，馬特，也很高興收到你的來信。我希望這裡有統計學家。我相信我們所擁有的功效計算約為 85%，而且 p 值小於 021。但目前它的動力充足，這就是我們讓獨立審查委員會查看數據的原因。

And in terms of how that works in terms of the independent review committee gives you an answer and then you do the full analysis. Is that the way it works? And [ when we would ] get the full analysis, okay.

至於如何運作，獨立審查委員會會給你一個答案，然後你進行全面的分析。是這樣的嗎？ [當我們]得到完整的分析時，好吧。

You're right. So what happens is the first step is they get to look at the data. Nobody at Eyenovia sees the data. So it's not open to us. So they see it, and then they say, yes or no, there's something here. If there is something here, then Eyenovia makes the decision to go ahead and open, excuse me, open the database at that point, and then we would do the full analysis, and that will take several days to see exactly what's in there.

你說得對。因此，第一步是他們查看數據。 Eyenovia 沒有人看到這些數據。所以不對我們開放。所以他們看到了，然後他們說，是或否，這裡有東西。如果這裡有任何東西，那麼 Eyenovia 就會決定繼續打開，對不起，此時打開資料庫，然後我們將進行全面分析，這將需要幾天的時間才能確切地看到裡面有什麼。

Okay. Great. And if this is positive and you do the analysis, what would be the time line to a potential NDA filing in this indication? And what would be the rate-limiting steps?

好的。偉大的。如果這是積極的並且您進行了分析，那麼針對該適應症提交潛在 NDA 的時間表是什麼？速率限制步驟是什麼？

Right. So if the analysis is positive and after talking with the FDA, they confirm that we have the way to move forward with the study, we could be looking at an NDA filing in the first half of 2026, which is about 2 years earlier than we had planning. So this is planned. So this is a great way to accelerate the entire program. In terms of what could be in the way, I'm not really sure that there would be anything because if we have a positive study, what the FDA would be looking for is efficacy and how does that compare to safety. And in the mask data, which we've been looking at, we have a great safety profile. There's been no significant adverse events that are treatment related than the AEs we do see are the ones that you would expect from this kind of therapy, and they've all been mild and very short-lived.

正確的。因此，如果分析結果是積極的，並且在與 FDA 交談後，他們確認我們有辦法推進這項研究，我們可能會在 2026 年上半年查看 NDA 申請，這比我們提前了大約 2 年有計劃。所以這是有計劃的。所以這是加速整個程序的好方法。就可能出現的問題而言，我不太確定會有什麼問題，因為如果我們有一項積極的研究，FDA 會尋找的是功效以及與安全性相比如何。在我們一直在研究的口罩數據中，我們有很好的安全性。沒有發生與治療相關的重大不良事件，而我們確實看到的不良事件是您在這種治療中所期望的不良事件，而且這些不良事件都很輕微且非常短暫。

And are you able to leverage the existing atropine safety data to facilitate the NDA filing?

您是否能夠利用現有的阿托品安全資料來促進 NDA 備案？

Well, the FDA is allowing us to use the LAMP study and the ATOM study in place of one Phase III study. So yes, for that. For us, I'm sure that we'll want to reference that, but I think we'd love to have our safety data in that label because I believe, and I haven't seen the data yet that our safety profile may be superior to what you would get with an eye drop just simply because we have the lower dose volume.

嗯，FDA 允許我們使用 LAMP 研究和 ATOM 研究來取代一項 III 期研究。所以是的，為此。對於我們來說，我確信我們會想要參考這一點，但我認為我們希望在該標籤中包含我們的安全數據，因為我相信，而且我還沒有看到我們的安全概況可能的數據優於滴眼液，只是因為我們的劑量較低。

The next question is from Lachlan Hanbury-Brown from William Blair.

下一個問題來自威廉·布萊爾的拉克蘭·漢伯里·布朗。

I guess, first, can you just help us understand the revenue number in the quarter? I mean it looks like it was down over Q2, but you did report an increase in the number of centers or practices using MydCombi. So can you just explain the dynamics there?

我想，首先，您能幫我們了解一下本季的營收數字嗎？我的意思是，看起來比第二季度有所下降，但您確實報告使用 MydCombi 的中心或診所數量有所增加。那你能解釋一下那裡的動態嗎？

Yes. So we're super excited about MydCombi. We have it in over 200 offices with a good response from those folks. Our next goal is to continue to push that out to additional offices with the goal of having 200 more. So the revenue number in Q3 is about $2,000. We think we could go up from there. As you know, we have a loss on those sales, but that was to be expected. And one of the benefits of getting this out there, in addition, obviously, to the cash flow that we get from it is just having the product out there being used, providing feedback on it as we progress to Gen 2. But I think that revenue number also reflects that we were preparing for the launch of clobetasol, and we feel like having both of those products out there with our sales team will benefit both channels in the current and future quarters.

是的。因此，我們對 MydCombi 感到非常興奮。我們在 200 多個辦事處設有該系統，並得到了人們的良好回應。我們的下一個目標是繼續推廣到更多辦事處，目標是再增加 200 個辦事處。因此第三季的營收約為 2,000 美元。我們認為我們可以從那裡上升。如您所知，我們在這些銷售方面出現了損失，但這是可以預料的。顯然，除了我們從中獲得的現金流之外，推出該產品的好處之一就是讓該產品得到使用，並在我們進入第二代時提供反饋。倍他索，我們認為我們的銷售團隊將這兩種產品提供給當前和未來幾季的兩個管道。

Right. Let me add to that also, and thank you, Andy, that MydCombi, like any pharmaceutical product, when you go and you launch it, the first thing you're going to do is you're going to bring samples into the marketplace because people are going to want to try your new product. In this case, we're bringing a brand-new technology that people need to be exposed to, they need some training and they need to use it actually on patients. So what you're seeing here is that while we're in over 200 offices now, it's because we've pre-qualified these offices as potential MydCombi offices, placed product in there as samples and they've been using them, and now they're reordering. So you're going to see the reorders come in the fourth quarter. We had, for example, the University of California just had ordered 15 more cartridges in the past couple of days. So now that they've actually used it and they see its benefit, they're ordering more of it. And that's why the sales force is now going to be let loose to sample another 200 offices and do the same sort of thing. And then lastly, what Andy had said about helping to leverage clobetasol, it does do that because we can bring both of the products in, they solve 2 different issues for the same thing. Pre-surgical, you have MydCombi, and then post-surgical, you have clobetasol. So it's a nice way to round out that sales call.

正確的。讓我補充一點，謝謝你，安迪，MydCombi，就像任何醫藥產品一樣，當你推出它時，你要做的第一件事就是將樣品帶入市場，因為人們會想嘗試你的新產品。在這種情況下，我們帶來了一種全新的技術，人們需要接觸它，他們需要一些培訓，他們需要實際將它用於患者。所以你在這裡看到的是，雖然我們現在有200 多個辦事處，但這是因為我們已經將這些辦事處預審為潛在的MydCombi 辦事處，並將產品作為樣品放在那​​裡，他們一直在使用它們，現在他們正在重新排序。因此，您將在第四季度看到重新訂購。例如，加州大學在過去幾天剛剛訂購了 15 個墨盒。因此，既然他們已經實際使用了它並且看到了它的好處，他們就會訂購更多。這就是為什麼銷售人員現在要抽出時間去另外 200 個辦事處進行抽樣並做同樣的事情。最後，安迪所說的關於幫助利用氯倍他索的說法，它確實做到了這一點，因為我們可以將這兩種產品引入，它們解決了同一件事的兩個不同問題。手術前，您使用 MydCombi，手術後，您使用氯倍他索。因此，這是完成銷售拜訪的好方法。

Great. And on clobetasol, it sounds like you're seeing good interest. Can you maybe just talk a bit more about what you're seeing sort of in the field? I think you said you were in 100 pharmacies for offices. Is there anything you can provide on sort of how many doctors have used it or anything along those lines at this point?

偉大的。聽起來您對氯倍他索很感興趣。能多談談您在現場看到的情況嗎？我記得你說過你在 100 家藥局有辦公室。您能提供一些關於有多少醫生使用過它的資訊嗎？

I don't have those figures, but what I can tell you is what we're finding is that the doctors are very attractive to the profile and very interestingly, more attractive to how we're distributing because they do have so many problems with prior authorizations and other issues with managed care for this class of drugs. And we find that what's working very well for us is we are selling clobetasol into the mom-and-pop pharmacies that are usually located in the medical arts buildings and the other places near where the surgeons are. And they just very simply write the product, the patient goes downstairs, picks it up. The price is always the same regardless of their insurance status, no mess, no fuss, and that's working for them. And we're getting reorders now from those pharmacies. So that is something that's working great, and we look forward to finding more of those opportunities.

我沒有這些數據，但我可以告訴你的是，我們發現醫生對個人資料非常有吸引力，而且非常有趣的是，對我們的分配方式更有吸引力，因為他們確實有很多問題此類藥物的管理式醫療的事先授權和其他問題。我們發現，對我們來說非常有效的是，我們將氯倍他索出售給夫妻藥房，這些藥房通常位於醫學藝術大樓和外科醫生所在的其他地方。他們只是非常簡單地寫下產品，病人下樓，拿起它。無論他們的保險狀況如何，價格總是相同的，沒有混亂，沒有大驚小怪，這對他們來說很有效。我們現在正在從這些藥局收到重新訂購的產品。因此，這是一種非常有效的方法，我們期待找到更多這樣的機會。

The next question is from Kemp Dolliver from Brookline Capital Markets.

下一個問題來自 Brookline Capital Markets 的 Kemp Dolliver。

Great. A couple of questions. First on MydCombi, when you mentioned 200 additional offices, did you mention a time frame for that?

偉大的。有幾個問題。首先在 MydCombi 上，當您提到另外 200 個辦事處時，您是否提到了特定的時間範圍？

Kemp, I didn't, but I'll share it with you now. They're going to hit those 200 offices this quarter.

坎普，我沒有，但我現在會跟你分享。他們將在本季度涵蓋這 200 個辦事處。

Okay. Fabulous. And -- when we -- the office statistic is one way -- it's kind of like a biomarker because offices vary in their size and traffic levels. So how should we think about, say, the number of whether your technicians or physicians, how many units are out there roughly?

好的。太棒了。而且——當我們——辦公室統計數據是一種方式——它有點像生物標記，因為辦公室的規模和交通水平各不相同。那我們該如何考慮，比如說，你的技術人員或醫生的數量，大約有多少單位？

Right. We don't go into a -- we pre-qualify an office to have at least 5 lanes. So you would usually have 5 techs with their doctors working simultaneously. So that would be the minimum size office that we would be going into.

正確的。我們不會對辦公室進行資格預審，要求其至少有 5 個車道。因此，通常會有 5 位技術人員和他們的醫生同時工作。所以這將是我們要進入的最小規模的辦公室。

Great. That's very helpful. And my last question is to go back to the relationship between revenue and cost of sales this quarter because in prior quarters, we've seen some costs that were related to buying back the MicroPine inventory from Bausch & Lomb and completely unrelated to MydCombi. So this quarter, is this an apples-to-apples relationship? Or are there other expenses in there?

偉大的。這非常有幫助。我的最後一個問題是回到本季營收和銷售成本之間的關係，因為在之前的幾季中，我們看到了一些與從Bausch & Lomb 回購MicroPine 庫存相關的成本，而與MydCombi 完全無關。那麼本季度，這是一種同類關係嗎？還是還有其他費用在裡面？

No, the cost to reacquire the product on our former relationship, those would be outside of cost of goods sold. So those wouldn't be included in that number. The numbers you're seeing coming through COGS are adjustments primarily for either short-dated inventory or for overhead that's applied to finished goods that we have to reduce the net realizable value. So those numbers can fluctuate depending on what we have in terms of inventory and when that might expire or in terms of how much overhead that we're [ applying product. ] We anticipate as those volumes increase, that number would change. I think when you're comparing, for example, the second quarter with the third quarter this year, I'd say that those were different adjustments. I think in the second quarter, it was more related to short dating on some of our finished goods that we had produced early on in the commercialization and the development of that inventory. Another thing to point out about these losses is that, much of those costs, as I mentioned, they might be overhead or they might be inventory. Those costs are all sunk costs. So they're not a huge -- they're not a drain on our cash because those have already been committed in terms of overhead or in terms of inventory purchases. But we'll continue to look at those every quarter. But I don't personally see anything alarming here. And I think the adjustments have been a little bit different each quarter, but we'll continue to look at them, and we'll probably continue to see some of that. But as I mentioned, as we grow other channels in this channel, we expect those -- the magnitude of those to wane.

不，根據我們以前的關係重新購買產品的成本，這些成本不包括在銷售商品成本中。所以這些不會包含在這個數字中。您透過銷貨成本看到的數字主要是針對短期庫存或應用於成品的間接費用的調整，我們必須減少可變現淨值。因此，這些數字可能會根據我們的庫存情況以及庫存何時到期或我們[應用產品的開銷]而波動。 ] 我們預計，隨著數量的增加，這個數字將會改變。我認為，例如，當您比較今年第二季和第三季時，我會說這些是不同的調整。我認為在第二季度，這更多地與我們在商業化和庫存開發早期生產的一些成品的短期約會有關。關於這些損失需要指出的另一件事是，正如我所提到的，其中大部分成本可能是間接費用，也可能是庫存。這些成本都是沉沒成本。所以它們並不是一個巨大的——它們不會消耗我們的現金，因為這些已經在管理費用或庫存採購方面得到了承諾。但我們將繼續每季關注這些內容。但我個人並沒有看到任何令人擔憂的事情。我認為每個季度的調整都略有不同，但我們將繼續關注它們，我們可能會繼續看到其中的一些調整。但正如我所提到的，隨著我們在這個管道中發展其他管道，我們預計這些管道的規模將會減弱。

The next question is from Len Yaffe from Stoc Doc Partners.

下一個問題來自 Stoc Doc Partners 的 Len Yaffe。

I had 2 questions for you, Michael. The first is you touched on this, but given with MicroPine, you're looking at a pediatric population, which are very sensitive to drug delivery. Could you talk about the advantages that the Optejet will likely have versus traditional dispensing to make sure you're getting the right dose in the patient in order to be able to have the appropriate effect? And then the second question, and you may have mentioned this, I could have missed it, was I'm trying to understand -- well, I know that there may be -- that there's scheduled to be possibly the interim look soon. But when will the public, when will an announcement be made in terms of what those top line results are? Because I'm trying to understand the time frame given your current cash position to when shareholders, potential investors would understand what the top line data are.

我有兩個問題想問你，麥可。首先，您談到了這一點，但是考慮到 MicroPine，您正在研究的是兒科人群，他們對藥物輸送非常敏感。您能否談談 Optejet 與傳統配藥相比可能具有的優勢，以確保您為患者提供正確的劑量，從而能夠產生適當的效果？然後第二個問題，你可能已經提到了這一點，我可能會錯過它，是我試圖理解 - 嗯，我知道可能會有 - 計劃很快就會進行臨時調查。但什麼時候向公眾公佈這些最重要的結果呢？因為我試圖了解股東目前現金狀況的時間範圍，潛在投資者將了解頂線數據是什麼。

Thank you, Len. Let me answer the second question first. The independent data review committee, which is truly independent from us, they are meeting very, very shortly. Now getting them to meet when they're all very busy, well-recognized experts in the field, I'm sure has not been an easy feat for the Chairman of that committee, but that should be happening any day now. And once that does happen and we get an answer from them, our commitment is to share that answer within a day of when we have it. So all of those...

謝謝你，萊恩。我先回答第二個問題。獨立數據審查委員會真正獨立於我們，他們很快就會開會。現在讓他們見面，而他們都是非常忙碌的、該領域公認的專家，我相信對於該委員會的主席來說並不是一件容易的事，但這應該隨時都會發生。一旦發生這種情況並且我們從他們那裡得到答案，我們承諾在收到答案後的一天內分享該答案。所以所有這些...

But is it [ the data ] or is it just a yes, a go/no-go?

但這是[數據]還是只是一個「是」、「進行/不進行」？

The answer is just the go/no-go. It's going to take us about, I would say, several weeks after that to actually dig into the data to say exactly what's in there. But the go/no-go is going to tell you if it's go, there was at least one arm that was statistically superior to placebo. So that's pretty significant information just from that. For what I believe our product offers that's superior to eye drops in pediatrics, there's a number of things. If anybody who's been a parent has ever tried to administer eye drops to their child, they know that, that's difficult to begin with just to do that, never mind the child doing it by themselves. I think the exposure is another issue. You have less systemic exposure with the Optejet than you would with an eye drop just purely because you have less volume. And we actually have published data on phenylephrine, for example, that shows that, that difference is about 33%. And when you're talking about a 40 or 50 or 70 pound child, that could be meaningful, that systemic exposure over 3 years. Topical tolerability, the stinging that's associated with low pH eye drops that you don't seem to get the same kind of reaction with the Optejet because it's the lower volume and it's gently sprayed on to the eye. And then, of course, all the compliance assistance that you get with the Optejet. So you can actually see what the child is doing because if child is not taking the medication, it's not going to do the many good over the long-term. So there's just -- those are 4 things I can think of off the top of my head. I'm sure there's probably others as well, and we see those as meaningful differences.

答案只是走/不走。我想說，在那之後我們需要大約幾週的時間才能真正深入研究數據以準確說出其中的內容。但通過/不通過會告訴你是否成功，至少有一隻手臂在統計上優於安慰劑。因此，這就是非常重要的訊息。我相信我們的產品在兒科方面優於眼藥水，有許多優點。如果任何為人父母的人曾經嘗試過給孩子滴眼藥水，他們就會知道，剛開始這樣做是很困難的，更不用說孩子自己做了。我認為曝光是另一個問題。使用 Optejet 時，您的全身暴露量比使用眼藥水時少，這純粹是因為您的體積較小。例如，我們實際上已經發布了有關去氧腎上腺素的數據，表明這種差異約為 33%。當你談論一個 40 磅、50 磅或 70 磅的孩子時，這可能是有意義的，即 3 年多的全身暴露。局部耐受性，即與低 pH 值滴眼液相關的刺痛感，但使用 Optejet 時似乎不會出現相同的反應，因為它的體積較小，並且輕輕地噴在眼睛上。當然，還有您透過 Optejet 獲得的所有合規幫助。因此，您實際上可以看到孩子在做什麼，因為如果孩子不服用藥物，長遠來看不會產生太多好處。所以這就是我能立即想到的四件事。我確信可能還有其他差異，我們認為這些差異是有意義的。

Great. And then just so I understand again, the independent committee will evaluate the data, let you know and then you'll take a couple of weeks to go through the data. When would be the earliest that the public will be aware of what the top line results are? Is it soon after that? Or is it not for another quarter or 2?

偉大的。然後我再次理解，獨立委員會將評估數據，讓您知道，然後您將花費幾週的時間來查看數據。公眾最早什麼時候才能知道最重要的結果是什麼？是在那之後不久嗎？還是再過一兩個季度就不行了？

No, it will be -- it won't be another quarter or 2. It will be, I would say, within a quarter, within the same quarter.

不，它會的——不會是另一個季度或兩個季度。

The next question is from Kemp Dolliver from Brookline Capital Markets.

下一個問題來自 Brookline Capital Markets 的 Kemp Dolliver。

I never left. I just want to clarify the timetable based on your -- a couple of your comments because earlier on, you made reference to your review taking several days. And then you said just now that it will take several weeks. I don't know if we're -- if those refer to the same steps in the process. But I just want to be clear that I understand the timetable you laid out.

我從未離開過。我只是想根據您的一些評論來澄清時間表，因為早些時候您提到您的審核需要幾天時間。然後你剛才說這需要幾週的時間。我不知道我們是否——這些是否指的是過程中的相同步驟。但我只是想澄清，我理解你列出的時間表。

I'm sorry. So I'm not sure exactly when we're going to get the information from the data review committee. When we do have that, we will share that very quickly. And then we will take the time, and I don't know if the time is going to be a week or it's going to be 4 weeks to go through that data. But as soon as that analysis is done, that's when we will share it. But prior to that even happening, when that DRC recommendation is communicated to us, we will share that, and that in itself is a pretty meaningful event.

對不起。所以我不確定我們什麼時候才能從數據審查委員會獲得資訊。當我們確實做到了時，我們會很快分享。然後我們會花時間，我不知道是一周還是四個星期來檢查這些數據。但一旦分析完成，我們就會分享它。但在此之前，當剛果民主共和國的建議傳達給我們時，我們將分享這一點，這本身就是一個非常有意義的事件。

Okay. Great. So it's essentially going to be potentially 2 disclosures?

好的。偉大的。所以這本質上可能是兩次披露？

Yes. I would say that's correct.

是的。我想說這是正確的。

This concludes the question-and-answer session. I would like to turn the floor back over to Michael Rowe for closing comments.

問答環節到此結束。我想將發言權交還給邁克爾·羅（Michael Rowe）以供結束評論。

Thank you, operator, and thanks to everyone on the call today for taking the time to join us. This is an exciting time to be with Eyenovia as we prepare for several transformative events all occurring in the next few months. Many of those events will be discussed at an upcoming R&D webinar scheduled for Wednesday, December 11, at 1:00 p.m. Eastern Time. The webinar will feature 3 leading and well-published doctors who will cover the unmet medical and other opportunities that are and can be addressed by our products, MydCombi, clobetasol and MicroPine. More information about this event will be coming out just before Thanksgiving, both through a press release and on our website, eyenovia.com. We invite all of you to register for what we anticipate will be a very informative session. Thank you again. This concludes our call, and we look forward to talking with you again very soon.

謝謝接線員，也感謝今天通話中的所有人抽出時間加入我們。與 Eyenovia 合作是一個令人興奮的時刻，我們正在為未來幾個月發生的幾項變革性事件做準備。其中許多活動將在即將於 12 月 11 日星期三下午 1:00 舉行的研發網路研討會上進行討論。東部時間。這場網路研討會將邀請 3 位發表文章的頂尖醫生參加，他們將介紹我們的產品 MydCombi、氯倍他索和 MicroPine 所解決的未滿足的醫療和其他機會。有關此活動的更多資訊將在感恩節前透過新聞稿和我們的網站 eyenovia.com 發布。我們邀請大家報名參加我們預計將是一次資訊豐富的會議。再次感謝您。我們的通話到此結束，我們期待很快再次與您交談。

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

今天的電話會議到此結束。此時您可以斷開線路。感謝您的參與。