Hyperion DeFi Inc (HYPD) 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.

大家好，歡迎參加 Eyenovia 2024 年第三季財報電話會議。（操作員指示）提醒一下，本次會議正在錄音。

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

現在我很高興介紹您的主持人，來自投資者關係部門的 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.

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。今天與我一起的有 Eyenovia 的首席執行官 Michael Rowe；營運長 Bren Kern；以及新任命的財務長安迪瓊斯（Andy Jones）。歡迎大家。

This afternoon, we issued a press release announcing financial results for the three 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.

今天下午，我們發布了一份新聞稿，宣布了截至 2024 年 9 月 30 日的三個月的財務表現。我們鼓勵大家閱讀今天的新聞稿以及 Eyenovia 剛剛向美國證券交易委員會提交的截至 2024 年 9 月 30 日的第二季 10-Q 表季度報告。該公司的新聞稿和年度報告也可在我們的網站 www.eyenovia.com 上查閱。此外，本次電話會議將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。

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.

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，今天電話會議上討論的某些資訊屬於《私人證券訴訟改革法案》安全港條款的保護範圍。我們提醒聽眾，Eyenovia 的管理層將在通話期間發表前瞻性陳述。由於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明確或暗示的結果有重大差異。這些前瞻性陳述受多種風險影響，這些風險在我們的 10-K 表年度報告和隨後的 10-Q 表季度報告中有更詳細的描述。

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.

本次電話會議包含時間敏感訊息，僅截至本次直播之日（2024 年 11 月 12 日）準確。Eyenovia 不承擔修改或更新任何前瞻性聲明以反映本次電話會議召開日後事件或情況的義務，除非適用的證券法可能要求。

With that said, I'd like to turn the call over to Michael Rowe, Eyenovia's Chief Executive Officer. Michael, the floor is yours.

說完這些，我想把電話轉給 Eyenovia 的執行長 Michael Rowe。邁克爾，現在你來發言。

Thank you, Eric, and welcome, everyone, to our third-quarter 2024 financial results conference call.

謝謝 Eric，歡迎大家參加我們 2024 年第三季財務業績電話會議。

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 3 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.

在第三季度，我們在將 Eyenovia 轉變為基於我們的 Optejet 技術改善局部眼科藥物效果的領導者方面取得了重大進展。首先，也是近期，我們正在迅速接近兒童進行性近視產品 MicroPine 的潛在 3 期療效數據讀數，該產品如果獲得批准，將為我們帶來價值數十億美元的潛在市場機會。其次，我們正在推動下一代 Optejet 技術，我們對這項進展以及這對我們的獲利狀況意味著什麼感到非常興奮。

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 three compounds in late-stage development and partially funded through our strategic partners.

第三，我們一直在商業化我們的散瞳產品 MydCombi，這是第一個基於 Optejet 技術的 FDA 批准產品，同時我們也推出了第二個 FDA 批准的產品氯倍他索，這是一種具有高度理想特性的先進眼科類固醇。第四，我們正在推進用於治療乾眼症的 Optejet 開發管線，其中氯倍他索作為後期開發中三種化合物的基石，部分資金來自我們的戰略合作夥伴。

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 US alone, of the nearly 20 million children with myopia, approximately 5 million are considered at risk of losing functional vision due to this disease.

現在，讓我們深入了解 MicroPine，這是我們基於 Optejet 的用於治療兒童進行性近視的低劑量阿托品候選產品。兒童進行性近視在美國乃至全球範圍內越來越被認為是一種流行病。僅在美國，在近2000萬患有近視的兒童中，約有500萬被認為面臨因這種疾病而失去功能性視力的風險。

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 myopic 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.

雖然眼鏡和隱形眼鏡是目前對患有進行性近視的兒童的標準治療方法，但它們並不總是適合最小的孩子，因為他們也是近視發展風險最高的。許多年幼的孩子無法很好地適應隱形眼鏡，很難將東西戴到眼睛上，或者可能由於佩戴隱形眼鏡的技術不佳而導致受傷或生病。

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 3 CHAPERONE study as young as six 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.

先前的 LAMP 和 ATOM 等研究表明，阿托品可以減緩近視的發展，我們相信，透過 Optejet 施用我們的專有阿托品配方可能帶來傳統眼藥水無法比擬的益處。借助 Optejet 技術，我們第三階段 CHAPERONE 研究中年僅六歲的兒童可以在父母極少的監督下每晚自行服藥。他們可以自行給藥，因為 Optejet 不需要傾斜頭部或操縱眼藥水或瓶子，只需透過內置鏡子瞄準並給藥即可。

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.

服藥本身感覺就像輕輕的霧氣，孩子們很快就熟悉並適應了服藥過程。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 注射阿托品所產生的副作用明顯較少且較輕。這些結果與我們對先進的藥物裝置給藥系統的期望一致。

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.

在整個試驗過程中，我們的工程師一直在透過嵌入式韌體追蹤 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。每次按下劑量按鈕來給藥時，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。

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.

對於商業產品，我們預計 MicroPine 將配備我們的 Opticare 系統，該系統可以通知患者及其父母和照護者何時使用噴霧劑量，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計劃來驗證該系統，這是我們預期的未來 NDA 提交的一部分。

We are continuing to advance the Phase 3 CHAPERONE study and are looking forward to the outcome of an analysis of the three-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.

我們正在繼續推進第三階段 CHAPERONE 研究，並期待很快得到三年療效和安全性數據分析的結果。如果獨立數據審查委員會進行的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 討論加快提交 NDA 的途徑，最早在 2026 年初。我們期待在 12 月 11 日即將舉行的 KOL 虛擬活動期間提供有關該計劃的更多更新。

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.

現在，讓我們來談談我們的團隊在第二代 Optejet 方面所取得的進步。我們最近完成了第一階段的生產註冊批次，目前正在準備對這些墨盒進行滅菌和隨後的藥物穩定性測試。這是FDA審查該技術過程中的關鍵一步。我們以 MydCombi 為先，因為這是我們最快捷的註冊途徑，而我們相信這將為所有後續開發用於 Optejet 的產品奠定基礎。

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.

提醒一下，第二代設備比第一代設備有許多進步，包括一鍵使用和與我們的數位合規監控程式 Opticare 的兼容性。它還採用了更少的零件，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% 的利潤率。我們認為第二代 Optejet 的推出是該公司即將到來的重要轉捩點。

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.

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，它降低了我們的 Optejet 技術的風險。在 MydCombi 獲得批准之前，眼科領域尚無其他產品將藥品批准與含電子設備的裝置結合。我們與 FDA 密切合作，確定了獲得設備批准所需的各種活動、研究和驗證流程，這使得 MydCombi 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就是一個偉大的里程碑，現在我們被公認為眼科護理領域該技術的領導者。

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.

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，我們在約 200 個辦公室安裝了 MydCombi，並與這些醫生及其技術人員密切合作，以進一步了解他們對 Optejet 平台的看法。我們發現，使用 MydCombi 50 次（大約一週）後，醫生和技術人員都對眼藥水的改變感到非常滿意。

We also found that four out of five 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 three 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.

我們還發現，五分之四的眼科護理專業人士認為 MydCombi 比眼藥水有顯著改善，特別是在為老年人、兒童和需要更快返回工作崗位的人進行擴瞳時，因為他們使用 MydCombi 的經驗是，瞳孔擴張的持續時間不像使用眼藥水那麼長，這是非常理想的。由於這些積極的發現，我們的銷售團隊現在專注於三件事：主要機構的處方接受度、保留現有辦事處以及在未來幾個月內轉換另外 200 個辦事處，他們現在正在努力實現這些目標。

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.

在將電話轉給布倫之前，我想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 因個人原因辭去董事長職務。他將繼續留任董事會，並繼續擔任我們的執行醫療顧問。

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.

自 2018 年起擔任我們董事會成員的查爾斯·馬瑟 (Charles Mather) 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，他的指導對我們幫助很大，使我們的公司能夠獲得足夠的資金來推進我們的發展計劃。我們很高興，在 Eyenovia 的這個重要時刻，我們將繼續擁有 Charlie 和 Sean 作為董事會的重要資源。

At this point, I'll turn the call over to our Chief Operating Officer, Bren Kern. Bren?

現在，我將把電話轉給我們的營運長布倫‧科恩 (Bren Kern)。布倫？

Thanks, Michael.

謝謝，麥可。

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.

九月底，我們宣布合作夥伴台塑製藥研發的氯倍他索正式上市並投入商業使用。氯倍他索已獲得FDA批准，用於治療眼科手術後的疼痛和炎症，也是15年來首個上市的新型眼科類固醇。由於其良好的療效和安全性、每天兩次的便捷給藥方案以及旨在消除保險複雜性的簡化分發，我們看到醫生們的濃厚興趣，並且已經將氯倍他索投放到支持 100 多個診所的當地藥房。

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.

氯倍他索與我們經 FDA 批准且可商購的散瞳劑 MydCombi 完美補充，為眼科診所提供額外的價值，同時最大限度地提高我們 10 人銷售團隊的利用率。辦公室普遍對氯倍他索和 MydCombi 都感興趣。氯倍他索的上市標誌著我們商業策略實施邁出了實質的一步。

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.

我們也公佈了佣金市場調查的結果，顯示眼科醫生在審查了處方資訊後表現出了濃厚的興趣。 100名眼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。

In clinical studies of clobetasol, approximately 80% of patients had complete relief from pain as soon as four 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 two characteristics piqued the surgeons interest.

在氯倍他索的臨床研究中，約 80% 的患者在手術後四天內疼痛得到完全緩解，而使用載體的患者比例僅為 50%。氯倍他索的安全性資訊也很重要，同一研究結果也表明，沒有任何單一不良事件影響超過 2% 的患者。這兩個特點激起了外科醫生的興趣。

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.

研究也顯示，管理式醫療保險的挑戰是大多數醫生關心的一大問題。Eyenovia 透過以低廉的固定價格向患者提供氯倍他索（無論他們的保險狀況如何）來解決這些問題。外科醫生認為，這是消除經常給辦公室工作人員帶來負擔的保險複雜性的好方法。總之，僅根據實際處方資訊和價格接受調查的大多數外科醫生都對開立氯倍他索表現出很高的興趣。

Turning now to our manufacturing facilities, recently, we successfully completed two 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.

現在談到我們的製造設施，最近，我們成功完成了對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，另一次由 FDA 審核。取得這些許可證使 Eyenovia 能夠製造、儲存、運輸和分銷我們的產品，這是 Eyenovia 轉型為商業公司的另一個重要步驟。

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 three 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 US and $5 billion globally. Symptoms of dry eye can significantly interfere with daily life and many patients remain unsatisfied with available therapies.

現在我想換個話題，介紹一下我們的合作關係的最新情況，首先從乾眼症開始。回想一下，在我們上一次的季度更新中，我們分別討論了三項開發合作協議——每種藥物都是利用我們的 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，全球的治療費用總計超過 50 億美元。乾眼症的症狀會嚴重干擾日常生活，許多患者對現有的治療方法並不滿意。

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.

根據我們最近由美國眼科學會進行的調查，48% 的患者報告說他們仔細遵循了治療計劃，但只有 13% 的患者獲得了持久的緩解。我們對在乾眼症領域的合作協議感到非常興奮。

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 two 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.

簡單回顧一下 Formosa，我們簽署了一項協議，開發 Optejet 中的氯倍他索配方，作為治療急性乾眼症和其他適應症的潛在藥物。該開發案需要進行兩次為期 15 天的臨床試驗，在獲得 FDA 批准之前，Eyenovia 將免收任何前期費用，Formosa 也不會支付任何開發里程碑費用。

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.

對於千壽藥，我們也簽署了合作協議，開發一種治療慢性乾眼症的新型輔助治療方法。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 一起用於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，因為它被設計用於與其他乾眼症藥物一起使用。換句話說，我們相信它會是現有產品的補充，而不是與它們競爭。

We are working towards requesting a meeting with the FDA later this year, followed by anticipated completion of a Phase 2b study in 2025. If successful, the companies may expand this collaboration and initiate two Phase 3 studies by 2026. To date, SJP-0035 has been tested in prior Phase 1 and Phase 2 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.

我們正在努力在今年稍後與 FDA 會面，並預計在 2025 年完成第 2b 階段的研究。如果成功，兩家公司可能會擴大合作並在 2026 年前啟動兩項第三階段研究。迄今為止，SJP-0035 已在前期 I 期和 II 期研究中作為標準眼藥水對 250 名受試者進行了多劑量測試。透過這些研究，SJP-0035 耐受性良好，有望支持治療慢性乾眼症。

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 three or more phases, thereby improving its bioavailability, biodistribution and pharmacokinetics. We have been conducting feasibility and manufacturing testing with SGN's Phase 3-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 3-ready asset next year in chronic dry eye.

最後，我們與 SGN Nanopharma 達成了合作協議，以利用其專有的肌細胞奈米顆粒平台（即 MNP 平台）。該平台允許在三個或多個階段分佈活性藥物成分，從而提高其生物利用度、生物分佈和藥物動力學。我們一直在對 SGN 的處於 3 期臨床的眼用環孢菌素製劑 SGN-101 與我們的 Optejet 設備結合進行可行性和製造測試，以作為治療慢性乾眼症的潛在方法。這種起效更快的環孢菌素與 Optejet 分配器相結合，為這個龐大的服務不足的市場提供了一種強大的新治療選擇。透過與 SGN 的合作，我們希望明年能夠擁有一項針對慢性乾眼症的 III 期臨床試驗。

With these three agreements, we have the potential to make strong inroads into the entire dry eye market, a $3 billion annual addressable US 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 three of our products, MicroPine, Apersure and MydCombi in China and South Korea. This licensing program provides for sales royalties in addition to development milestones.

透過這三項協議，我們有可能強勢進軍整個乾眼症市場，這是一個每年價值 30 億美元的美國潛在市場，為數百萬尚未滿足需求的患者提供服務。現在，我將介紹我們與 Arctic Vision 現有的授權計劃的最新情況，該計劃涵蓋了我們在中國和韓國的所有三種產品：MicroPine、Apersure 和 MydCombi。該許可計劃除了提供開發里程碑之外，還提供銷售特許權使用費。

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 non-dilutive 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 three to six years. If our products are approved upon commercialization, we'd also be eligible to earn significant sales royalties.

正如邁克爾之前所說，MicroPine 在中國為兒童近視治療帶來了重大機遇，並且是價值 50 億美元的全球市場的一部分。如果獲得批准，MicroPine 可能成為該公司長期非稀釋性資金的潛在重要來源。到目前為止，我們與 Arctic Vision 簽訂的授權協議已產生了約 600 萬美元的授權費，並且我們有可能在未來三到六年內獲得額外的 3,700 萬美元的淨許可和開發里程碑收入。如果我們的產品在商業化後獲得批准，我們也將有資格獲得可觀的銷售特許權使用費。

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.

我們對 Optejet 為需要提供局部眼科藥物的患者提供的改進感到非常興奮，並相信該平台具有廣泛的實用性。為此，我們繼續評估我們的潛在管道擴展機會。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疾病。

I'd now like to turn the call over to our new Chief Financial Officer, Andy Jones. Andy?

現在我想將電話轉給我們新任財務長安迪瓊斯 (Andy Jones)。安迪？

Thanks, Bren. I'm very excited to be here with everyone today as part of the Eyenovia team.

謝謝，布倫。身為 Eyenovia 團隊的一員，我今天非常高興能和大家在這裡相聚。

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.

2024 年第三季度，我們報告淨虧損約 790 萬美元，即每股 0.11 美元，加權平均流通股約 6,950 萬股。相比之下，2023 年第三季的淨虧損為 730 萬美元，即每股 0.18 美元，加權平均流通股約為 4,010 萬股。

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.

第三季的毛虧損為 131,000 美元，而去年同期的毛虧損為 12,000 美元。損失主要由於在與 MydCombi 和我們的 Gen 1 設備相關的各個期間將庫存減記至可實現淨值的調整所致。我們的第一代設備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將抵消這些損失。

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.

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，這反映了內部資源重新分配到商業生產。

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.

2024 年第三季度，一般及行政費用約 370 萬美元，而 2023 年第三季為 290 萬美元，成長 27.3%。這一增長主要包括 647,000 美元的工資和福利，主要與公司商業化努力的開始有關。

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.

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。這意味著增長了約 10.6%。我們的 2024 年第三季營運費用數字還包括約 120 萬美元的非現金費用。

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.

截至 2024 年 9 月 30 日，我們報告的無限制現金約為 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，為我們目前的策略提供資金，並支付 Avenue 貸款的近期還款。

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.

此外，與往常一樣，我們繼續尋找提高營運效率和控制費用的方法。我們對我們的商業組合、我們的開發管道以及利用 Optejet 平台的當前和未來合作夥伴關係感到非常興奮。我們相信，憑藉新穎且高度差異化的技術和在多個非常大的眼科適應症市場中的應用，我們已經為成長為一家領先的眼科公司奠定了基礎。總之，我們對 2024 年第三季的進展以及後續階段的預期感到非常滿意。

To summarize our key highlights today, first, we are preparing for an analysis of the three-year efficacy data from our ongoing Phase 3 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.

總結我們今天的重點，首先，我們正在準備分析本季正在進行的 MicroPine 治療兒童進行性近視的 3 期 CHAPERONE 試驗的三年療效數據。如果是肯定的，這些數據可能會讓我們大幅推進剩餘的開發時間。此外，我們開始生產 MydCombi 的註冊批次和我們最先進的 Gen 2 Optejet 設備。

We also announced the US 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 US for which patients could potentially benefit from clobetasol, we believe that even a low single-digit market share would be very meaningful for us.

我們也宣布氯倍他索在美國上市並投入商業使用，這是 15 年來首個獲準的新型眼科類固醇。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是非常有意義的。

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.

我們與 Formosa、Senju 和 SGN 建立了開發合作關係，為 Optejet 開發新型治療配方，有望解決急性和慢性乾眼症領域尚未滿足的需求。此外，MydCombi 的商業發布繼續順利進行，該產品目前已在全國 200 多家眼科診所使用。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獲得銷售特許權使用費潛力的有希望的途徑。

This concludes our prepared remarks. We would now like to open the call to questions. Operator?

我們的準備好的演講到此結束。我們現在想開始提問。操作員？

(Operator Instructions) Matthew Caufield, H.C. Wainwright.

(操作員指示) Matthew Caufield，H.C.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?

那麼，當我們回顧 CHAPERONE 試驗時，設定期望值以定義成功最重要的差異是什麼？顯然，我們正在觀察小於 0.5 屈光度的近視進展。但是，當我們接近該讀數時，是否還有其他最具臨床意義或最相關的要點？

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.

謝謝你，馬特，這是一個非常好的問題。因此，這項研究的運作方式是，獨立審查委員會（該委員會真正獨立於我們，由該領域的專家醫生和驗光師組成）在開會後將告訴我們 CHAPERONE 研究中至少一種劑量是否與安慰劑相比具有統計意義。

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 three years of therapy.

一旦發生這種情況，我們的公司 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，即經過三年治療後，屈光度變化不超過 0.5 屈光度的患者數量或比例。

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.

但除此之外，我還想看看 Optejet 的一些特別之處。這些可能是諸如副作用概況之類的事情，因為我們使用的是眼科噴霧劑，所以我們預計它會比眼藥水更舒適，或者關於依從性的事情，我們希望看到研究中的兒童能夠比在歷史類似研究中看到的兒童更遵守治療。

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.

我們要考慮的另一個因素是還必須進行 PK 或血液水平評估。我們也希望看到，在研究過程中系統性地接觸阿托品的幾率非常小，這可能是另一個優點。所以這些都是 Optejet 交付的產品與我們想要看到的眼藥水之間的差異。

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，您介意我也簡單地問 CHAPERONE 一個問題嗎？

Sure.

當然。

So with that trial dosing as young as six 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，您提到的試驗性用藥最早在 6 歲時進行，那麼，在臨床實踐中，是否可以了解哪個年齡層的人最容易出現進行性近視？據推測，兒童的識別時間會比這早一點。這是準確的嗎？--

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 five years old, six 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.

正確的。因此該領域實際上有大量出版物。我們被告知的一件事是，識別這些孩子的方式是，通常是在他們上幼兒園時讓他們第一次接受眼睛檢查。所以他們五歲、六歲時就來就診，他們是近視的，醫生看了看，發現父母都是近視的。這通常是一個非常好的信號，表明可能存在遺傳因素，並且他們面臨的風險最大。

And you want to capture them when they're five, six, seven, eight 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.

你希望在孩子五、六、七、八歲時捕捉到他們的近視，因為近視的發展與眼睛的發展息息相關。因此，孩子在年幼時眼睛發育得越快、越多，進步就越大。當你遇到 14 或 15 歲的人時，你已經失去了很多機會。因此目標是找到它們，儘早找到它們。

Matt Kaplan, Ladenburg Thalmann.

馬特卡普蘭、拉登堡塔爾曼。

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?

這只是 CHAPERONE 中期分析的後續。當您進行這項中期分析時，您將獲得什麼樣的潛在動力？

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，我也很高興收到你的來信。我希望這裡有統計員。我相信，根據我們現有的數據，功效計算大約為 85%，且 p 值小於 021。如果我稍微偏離了一點，請不要責怪我，因為我正在努力回憶統計計劃中的內容。但目前它已經有足夠的動力，這就是我們讓獨立審查委員會審查數據的原因。

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 do you get the full analysis?

至於其運作方式，獨立審查委員會會給你一個答案，然後你進行全面的分析。就是這樣嗎？什麼時候能得到完整的分析？

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，第一步就是他們查看數據。Eyenovia 的任何人都看不到這些數據。所以它對我們不開放。所以他們看到它，然後說，是或不是，這裡有東西。如果這裡有東西，那麼 Eyenovia 就會決定繼續打開，對不起，打開資料庫，然後我們會進行全面的分析，這將需要幾天的時間才能確切地知道裡面有什麼。

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。如果結果是肯定的，並且您進行了分析，那麼針對此適應症提交潛在 NDA 申請的時間表是怎樣的？那麼速限步驟是怎樣的呢？

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 two years earlier than we had planning. So this is planned. So this is a great way to accelerate the entire program.

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 年上半年提交 NDA 申請，這比我們計劃的早了大約兩年。這是有計劃的。所以這是加速整個程序的好方法。

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.

至於可能的阻礙，我不太確定是否會有什麼，因為如果我們進行的是積極的研究，那麼 FDA 所尋求的就是療效，以及療效與安全性相比如何。在我們一直在關注的口罩數據中，我們發現其安全性很高。除了我們看到的不良事件外，沒有出現與治療相關的重大不良事件，這些不良事件都是此類治療所預期的，而且它們都很輕微且持續時間很短。

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 申請？

Well, the FDA is allowing us to use the LAMP study and the ATOM study in place of one Phase 3 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 3 期研究。是的，就是這樣。對於我們來說，我確信我們會想要參考這一點，但我認為我們更希望在標籤上有我們的安全數據，因為我相信，而且我還沒有看到數據表明我們的安全性可能優於眼藥水，僅僅是因為我們的劑量較低。

Lachlan Hanbury-Brown, William Blair.

拉克蘭·漢伯里·布朗，威廉·布萊爾。

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，您能幫助我們了解本季的收入數字嗎？我的意思是它看起來在第二季度有所下降，但你確實報告了使用 MydCombi 的中心或診所數量有所增加。那麼您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.

是的。所以我們對 MydCombi 感到非常興奮。我們在 200 多個辦事處都開展了這項活動，並且得到了人們的正面回應。我們的下一個目標是繼續推廣到更多辦事處，最終目標是增加 200 個。因此第三季的營收數字約為 2,000 美元。

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.

我們認為我們可以從那裡繼續前進。如您所知，我們在這些銷售中遭受了損失，但這是意料之中的。而推出這款產品的另一個好處是，除了能為我們帶來現金流之外，還能讓產品得到使用，並在我們邁向第二代產品的過程中提供回饋。但我認為收入數字也反映了我們正在為推出氯倍他索做準備，我們覺得我們的銷售團隊同時推出這兩種產品將使當前和未來幾季的兩個管道都受益。

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.

正確的。我還要補充一點，謝謝你，安迪，MydCombi 與任何醫藥產品一樣，當你推出它時，你要做的第一件事就是將樣品帶入市場，因為人們會想要嘗試你的新產品。在這種情況下，我們帶來了一項全新的技術，人們需要接觸這項技術，他們需要一些培訓，並且需要將它實際地用在患者身上。所以您在這裡看到的是，雖然我們現在已經涵蓋了 200 多個辦事處，但這是因為我們已經將這些辦事處預先認定為潛在的 MydCombi 辦事處，並將產品作為樣品放在其中，他們一直在使用它們，現在他們正在重新訂購。因此您將會在第四季看到重新訂單的出現。

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 two 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.

例如，加州大學在過去幾天剛剛訂購了 15 個墨盒。所以現在他們已經實際使用過並且看到了它的好處，所以他們訂購了更多。這就是為什麼現在要讓銷售人員去另外 200 個辦事處進行抽樣調查並做同樣的事情。最後，安迪所說的幫助利用氯倍他索，確實可以做到這一點，因為我們可以引入這兩種產品，它們解決了同一件事的兩個不同問題。手術前使用 MydCombi，手術後使用氯倍他索。所以這是完成銷售電話的一個好方法。

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。您能否再多談談您在該領域看到的情況？我記得您說過您在 100 家藥局設有辦事處。您能提供目前有多少醫生使用過它或類似資訊嗎？

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.

我沒有這些數據，但我可以告訴你的是，我們發現醫生們對我們的概況非常有吸引力，而且非常有趣的是，他們對我們的分銷方式更感興趣，因為他們在事先授權以及對這類藥物的管理醫療方面存在很多問題。我們發現，對我們非常有利的做法是，我們將氯倍他索銷售到通常位於醫學藝術大樓和外科醫生附近的其他地方的夫妻藥局。他們只是非常簡單地寫上產品，病人下樓去拿。

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.

無論他們的保險狀況如何，價格始終相同，沒有混亂，沒有麻煩，這對他們來說很有利。我們現在正在從這些藥局收到重新訂單。這是一件非常有效的事情，我們期待發現更多這樣的機會。

Kemp Dolliver, Brookline Capital Markets.

布魯克林資本市場 (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。幾個問題。首先關於 MydCombi，當您提到增加 200 個辦事處時，您是否提到了時間表？

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，但我現在想跟你分享。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。非常好。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流量水平各不相同。那麼，我們該如何考慮，比如說，你們的技術人員或醫生的數量，大約有多少個單位？

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

正確的。我們不會進入——我們預先確定一個辦公室至少有五條車道。因此，通常會有五名技術人員和他們的醫生同時工作。這就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收入和銷售成本的關係，因為在前幾個季度，我們看到一些成本與從博士倫回購 MicroPine 庫存有關，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 to the product. We anticipate as those volumes increase, that number would change.

不，根據我們以前的關係重新獲取產品的成本，這些不在銷售成本之內。因此這些不會被包括在該數字內。您透過 COGS 看到的數字主要是針對短期庫存或用於成品的間接費用進行的調整，我們必須降低這些費用以減少可實現淨值。因此，這些數字可能會波動，具體取決於我們的庫存情況、庫存何時到期或我們對產品支付的間接費用。我們預計，隨著數量的增加，這個數字將會改變。

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.

我認為當你比較今年第二季和第三季時，我會說它們是不同的調整。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。關於這些損失還有一點需要指出，正如我所提到的，其中大部分成本可能是間接費用或庫存。這些成本都是沉沒成本。因此，它們並不是巨大的——它們不會耗盡我們的現金，因為這些已經在管理費用或庫存採購方面投入了。

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.

但我們每季都會繼續關注這些問題。但我個人並不認為這有什麼值得擔憂的。我認為每個季度的調整都有點不同，但我們會繼續關注它們，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，我們預期這些管道的規模將會減弱。

Len Yaffe, Stoc*Doc Partners.

Len Yaffe，Stoc*Doc Partners。

I had two 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?

我有兩個問題想問你，麥可。首先，您提到了這一點，但考慮到 MicroPine 的應用，您關注的是兒科人群，他們對藥物輸送非常敏感。您能否談談 Optejet 與傳統分配技術相比可能具有的優勢，以確保患者獲得正確的劑量，從而獲得適當的效果？

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.

然後是第二個問題，你可能已經提到了這一點，我可能錯過了，我想了解 - 好吧，我知道可能有 - 可能很快就會安排臨時審查。但是什麼時候公眾才能公佈這些最重要的結果呢？因為我想了解您目前的現金狀況以及股東和潛在投資者何時能夠了解營收數據的時間範圍。

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，Len。我先回答第二個問題。獨立數據審查委員會是真正獨立於我們的，他們很快就會舉行會議。現在，讓他們這個領域內公認的專家在都非常忙碌的情況下開會，我相信對於該委員會主席來說並非易事，但這應該很快就會發生。一旦這種情況發生並且我們從他們那裡得到答复，我們承諾在一天之內分享該答复。因此所有這些--

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

但它只是數據嗎，還是只是「是」或「通過」/「不通過」？

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.

答案只是去/不去。我想說，我們大約需要幾週的時間才能真正深入研究數據，從而確切地知道其中的內容。但是，通過/不通過會告訴您是否可以進行，至少有一個組在統計上優於安慰劑。僅從這一點來看，這就是非常重要的訊息。我認為我們的產品比兒科眼藥水更勝一籌，原因有很多。

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 three years.

如果任何為人父母的人都曾嘗試給孩子滴眼藥水，他們就會知道，一開始就做到這一點就很困難，更不用說讓孩子自己做了。我認為曝光是另一個問題。與眼藥水相比，使用 Optejet 時全身暴露量較少，這純粹是因為劑量較小。例如，我們實際上已經發表了有關苯腎上腺素的數據，數據顯示，這種差異約為 33%。當你談論一個體重 40 磅、50 磅或 70 磅的孩子時，三年的系統暴露可能會很有意義。

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 four 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.

局部耐受性，與低 pH 值眼藥水有關的刺痛感，使用 Optejet 似乎不會出現同樣的反應，因為它的劑量較低，並且可以輕輕地噴灑到眼睛上。當然，您也會獲得 Optejet 提供的所有合規協助。所以你實際上可以看到孩子在做什麼，因為如果孩子不吃藥，從長遠來看，吃藥不會有好處。所以——這些就是我能想到的四件事。我確信可能還有其他的，我們認為這些都是有意義的差異。

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，並通知您，然後您需要花幾週時間來查看數據。公眾最早什麼時候能夠知道最終結果？那之後不久嗎？或者說不是在接下來的一、兩個季度？

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

不會，不會再等一、兩個季度了。我想說的是，它將在一個季度內，同一個季度內。

Kemp Dolliver, Brookline Capital Markets.

布魯克林資本市場 (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。我只是想根據您的幾條評論澄清時間表，因為之前您提到您的審查需要幾天時間。然後你剛才說這需要幾週。我不知道我們是否—這些是否指的是流程中的相同步驟。但我只是想清楚地表明，我了解你所製定的時間表。

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 four weeks to go through that data. But as soon as that analysis is done, that's when we will share it.

對不起。所以我不確定我們什麼時候能從數據審查委員會獲得資訊。當我們有此資訊時，我們會很快分享。然後我們會花時間，我不知道這個時間是一周還是四周來查看這些數據。但一旦分析完成，我們就會分享它。

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.

但在那之前，當 DRC 建議傳達給我們時，我們會分享這一點，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 two disclosures?

好的。偉大的。所以本質上可能會有兩項揭露？

Yes. I would say that's correct.

是的。我認為這是正確的。

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，請他發表最後評論。

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 PM Eastern Time.

謝謝接線員，也感謝今天通話中的每個人抽出時間加入我們。這是與 Eyenovia 一起度過的激動人心的時刻，我們正在為未來幾個月發生的幾項變革性事件做準備。其中的許多事件將在即將舉行的研發網路研討會上討論，該研討會定於 12 月 11 日星期三東部時間下午 1:00 舉行。

The webinar will feature three 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.

網路研討會將邀請三位頂尖且著述豐富的醫生，討論我們的產品 MydCombi、氯倍他索和 MicroPine 可以解決的未滿足的醫療條件和其他機會。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期待的一次非常有益的會議。

Thank you again. This concludes our call, and we look forward to talking with you again very soon.

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。現在您可以斷開您的線路。感謝您的參與。