Hyperion DeFi Inc (EYEN) 2023 Q1 法說會逐字稿

Greetings. Welcome to Eyenovia First Quarter 2023 Earnings Call. (Operator Instructions) Please note, this conference is being recorded. I will now turn the conference over to John Gandolfo, Chief Financial Officer. Thank you. You may begin.

問候。歡迎參加 Eyenovia 2023 年第一季財報電話會議。 （操作員指示）請注意，本次會議正在錄音。現在我將會議交給財務長約翰甘道夫 (John Gandolfo)。謝謝。你可以開始了。

Thank you. Good afternoon, and welcome to Eyenovia's First Quarter 2023 Earnings Conference Call and Audio Webcast. With me today are Eyenovia's CEO, Michael Rowe; and COO, Bren Kern.

謝謝。下午好，歡迎參加 Eyenovia 2023 年第一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；以及首席營運長 Bren Kern。

This afternoon, we issued a press release announcing financial results for the 3 months ended March 31, 2023. We encourage everyone to read today's press release as well as Eyenovia's quarterly report on Form 10-Q for the quarter ended March 31, 2023, which will be filed with the SEC tomorrow, May 12, 2023, as well as our most recently filed 10-K. 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 to the company's website and will be archived there for future reference. Please note that on today's call, we will be discussing investigational product candidates, some of which have yet to receive FDA approval.

今天下午，我們發布了一份新聞稿，宣布了截至 2023 年 3 月 31 日的三個月的財務業績。本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，並將存檔以供日後參考。請注意，在今天的電話會議上，我們將討論研究產品候選物，其中一些尚未獲得 FDA 批准。

Please also note that certain information discussed on the call today is covered under the safe harbor provisions 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 in our annual report on Form 10-K.

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, May 11, 2023. 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 applicable securities law.

本次電話會議包含時間敏感信息，這些信息僅在本次直播之日（2023 年 5 月 11 日）準確無誤。

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

說完這些，我想把電話轉給 Eyenovia 的執行長 Michael Rowe。麥可？

Thank you, John, and welcome, everyone, to our First Quarter 2023 Financial Results Conference Call. I will start with an update of our recent FDA approval of MydCombi, how that approval fits within our overall strategy and then provide established update for MicroLine. Bren Kern, our Chief Operating Officer, will follow with an update on our manufacturing and commercial readiness progress. We will then turn things over to John Gandolfo, our CFO, who will review the financials as well as our partnerships with Bausch + Lomb and Arctic Vision. We will then open the call for your questions.

謝謝您，約翰，歡迎大家參加我們的 2023 年第一季財務業績電話會議。我將首先介紹我們最近獲得 FDA 批准的 MydCombi 的最新情況，以及該批准與我們的整體策略如何契合，然後介紹 MicroLine 的既定最新情況。我們的營運長 Bren Kern 將隨後介紹我們的製造和商業準備進度。然後，我們將把事情交給我們的財務長約翰·甘道夫 (John Gandolfo)，他將審查財務狀況以及我們與博士倫 (Bausch + Lomb) 和 Arctic Vision 的合作關係。然後我們將開始回答你們的問題。

During the first quarter of this year and more recently, we have made significant progress on all of our stated goals, punctuated by FDA approval of our first product, MydCombi. We also received very encouraging feedback from the FDA and believe that we have a clear path forward for our MicroLine presbyopia program.

今年第一季及最近一段時間，我們在所有既定目標上都取得了重大進展，我們的第一款產品 MydCombi 也獲得了 FDA 批准。我們也收到了來自 FDA 的非常令人鼓舞的回饋，並相信我們的 MicroLine 老花眼計畫已經有一個明確的前進方向。

In terms of manufacturing, we are ramping up our activities and we'll have our Reno facility online next quarter with Optejet Gen2 clinical batches being produced later this year. Finally, our partnership with Formosa as well as others that we expect to come will pave the way for additional ophthalmic [opportunities] that leverage our Optejet technology.

在製造方面，我們正在加大力度，下個季度我們的里諾工廠將投入使用，並將於今年稍後生產 Optejet Gen2 臨床批次。最後，我們與 Formosa 以及其他公司的合作將為利用我們的 Optejet 技術的更多眼科[機會]鋪平道路。

I'll begin the call by highlighting our most recent achievement. Just a few days ago, we received FDA approval of MydCombi, our proprietary combination of a microdose formulation of tropicamide and phenylephrine, for inducing mydriasis for diagnostic procedures and in conditions where short-term pupil dilation is desired. This is the first approved fixed-dose combination of tropicamide and phenylephrine in the U.S. and, importantly, is also the first approved product using our Optejet dispensing device. I cannot overstate the importance to our company of this approval. The Optejet is foundational to our development pipeline as well as our partnered programs. And this FDA approval sets the precedent for the future development of additional ophthalmic therapies delivered by the Optejet in other high-value indications.

我首先將介紹我們最近的成就。就在幾天前，我們獲得了 FDA 批准的 MydCombi，這是我們專有的托吡卡胺和苯腎上腺素的微劑量配方組合，用於在診斷程序中以及需要短期瞳孔擴張的情況下誘導散瞳。這是美國首個獲批的托品醯胺和苯腎上腺素固定劑量組合，而且重要的是，它也是第一個使用我們的 Optejet 分配裝置獲批的產品。我不能過度強調這項批准對我們公司的重要性。 Optejet 是我們開發流程和合作專案的基礎。此次 FDA 的批准為未來 Optejet 在其他高價值適應症中提供的其他眼科治療方法的開發開創了先例。

The FDA's approval of MydCombi provides crucial external validation of our technology and is just the first of many ophthalmic indications that can utilize the Optejet. The approval also marks the formal transition of Eyenovia from a development company to a commercial organization. The management team is extremely grateful to all of our Eyenovia colleagues for their dedication in advancing this program through this important milestone.

FDA 批准 MydCombi 為我們的技術提供了重要的外部驗證，並且只是可以利用 Optejet 的眾多眼科適應症中的第一個。此次批准也標誌著Eyenovia從一家開發公司正式轉型為商業組織。管理團隊非常感謝所有 Eyenovia 同事為推動該計劃實現這一重要里程碑所做的貢獻。

Since Monday, we have received numerous inbound calls and e-mails from ophthalmology and optometry offices asking when they can get MydCombi. The reasons for wanting the product include the horizontal delivery, the lower drug volume exposure, ease of use for both, the doctors and technicians. One doctor said that she plans to modify her office flow, so that she could dilate patients right in the waiting room, and she didn't have to have them tilt their heads back. We, of course, see this as very encouraging.

自周一以來，我們收到了大量來自眼科和驗光辦公室的電話和電子郵件，詢問何時可以獲得 MydCombi。想要該產品的原因包括水平輸送、較低的藥量暴露、醫生和技術人員都易於操作。一位醫生說，她計劃改變辦公室的流程，這樣她就可以在候診室裡為病人做擴張手術，而不必讓他們往後仰頭。當然，我們認為這非常令人鼓舞。

We plan to introduce MydCombi later this summer to several key ophthalmology and optometry offices as part of our targeted launch process. As much as we would like to be out there tomorrow, we need some time to bring our internal manufacturing capabilities, which are more cost efficient online. By early 2024, we expect to have our facilities in Redwood City and Reno at full production capacity.

作為我們目標發布流程的一部分，我們計劃在今年夏天晚些時候向幾個主要的眼科和驗光辦公室推出 MydCombi。雖然我們希望明天就能上線，但我們需要一些時間來將我們更具成本效益的內部製造能力轉移到線上。到 2024 年初，我們預計位於雷德伍德城和里諾的工廠將達到滿載生產能力。

For now, customers and all of you can find out more about MydCombi and soon track our launch progress and ultimately hear what doctors and patients are saying about the product by going to the website mydcombi.com.

目前，客戶和所有人都可以訪問 mydcombi.com 網站以了解有關 MydCombi 的更多信息，並很快跟踪我們的發布進度，最終聽取醫生和患者對該產品的評價。

I'll now turn to MicroLine, our proprietary topical on-demand pilot parking based therapeutic candidate that we are developing for the temporary improvement in near vision associated with presbyopia. As you'll recall, presbyopia is the age-related hardening of the eye lens causing blurred near vision. This is an addressable market representing over 18 million people in the United States alone between the ages of 40 and 55, will otherwise never wear glasses and have the resources for a cash pay product. Our proprietary market research suggests, this could be a multibillion-dollar annual market in the U.S. alone.

現在我來談談 MicroLine，這是我們專有的局部按需試點停車治療候選藥物，我們正在開發這種藥物用於暫時改善老花眼相關的近距離視力。您可能還記得，老花眼是由於年齡相關的眼晶狀體變硬而導致的近視模糊。這是一個潛在的市場，僅在美國就代表著 1800 多萬年齡在 40 至 55 歲之間的人，如果不戴眼鏡，他們永遠不會戴眼鏡，也沒有能力購買現金支付產品。我們的專有市場研究表明，僅在美國，這可能是每年數十億美元的市場。

We recently received feedback from the FDA delineating a clear path forward for this program towards a New Drug Application or NDA. MicroLine is being designed for use with our smaller and more advanced Gen2 Optejet device, which has been optimized for in-home use. The machinery to build and fill the Gen2 cartridge is being installed and validated in our Redwood City facility. And we anticipate running NDA registration batches in the first half of 2024 after satisfying the contracted clinical needs of our partners.

我們最近收到了 FDA 的回饋，為該計劃邁向新藥申請或 NDA 劃定了明確的路徑。 MicroLine 設計用於我們更小巧、更先進的 Gen2 Optejet 設備，該設備已針對家庭使用進行了最佳化。用於製造和填充 Gen2 墨盒的機器正在我們的雷德伍德城工廠安裝和驗證。我們預計在滿足合作夥伴的合約臨床需求後，將於 2024 年上半年開始運行 NDA 註冊批次。

The FDA requires 12 months of real-time stability data on the final packaged product before filing the NDA. So we intend to file approximately 10 months after we run those batches.

FDA 要求在提交 NDA 之前提供最終包裝產品的 12 個月的即時穩定性數據。因此，我們打算在運行這些批次後大約 10 個月提交文件。

During those 12 months, however, we will not be sitting and waiting. We will be conducting other critical pre-NDA activities, including support of human factors and clinical work to demonstrate the usability of the Gen2 device in the target population as well as measuring patient preference for the Optejet system. This work will be used to support both, the MicroLine NDA and upcoming commercialization of the product.

然而在這 12 個月裡，我們不會坐等。我們將進行其他關鍵的 NDA 前活動，包括人為因素支援和臨床工作，以證明 Gen2 設備在目標族群中的可用性以及衡量患者對 Optejet 系統的偏好。這項工作將用於支援 MicroLine NDA 和即將到來的產品商業化。

As an ophthalmic spray in the Optejet device, we believe that MicroLine has a number of unique features that may set it apart from presbyopia eye-drop options. The features of our technology may make using the product easier, while lowering drug and preservative exposure and potentially improving tolerability. The attractiveness of the device itself has been pointed to as a highly desired feature in market research we have conducted. And MicroLine may also fit better with the business model of many optometrists. Many doctors have a retail portion of their practice where they sell eyeglasses, contact lenses and other products for presbyopic patients. MicroLine could fit well into their paradigm as they may be able to include supporting items such as unique device skins, starter kits and so on as part of those offerings.

作為 Optejet 設備中的眼科噴霧劑，我們相信 MicroLine 具有許多獨特的功能，可能使其有別於老花眼眼藥水選項。我們的技術特點可以使產品的使用更容易，同時降低藥物和防腐劑的暴露並可能提高耐受性。我們進行的市場調查表明，設備本身的吸引力是一個備受期待的功能。而且MicroLine可能也更適合許多驗光師的商業模式。許多醫生在其診所設有零售部門，銷售老花眼患者的眼鏡、隱形眼鏡和其他產品。 MicroLine 可以很好地融入他們的模式，因為他們可能能夠將諸如獨特的設備皮膚、入門套件等支援項目作為這些產品的一部分。

We recently conducted market research with 100 optometrists where MicroLine was compared with the 5 existing or potential presbyopia eye drops that may be on the market in 2025. What we found was that MicroLine was rated #1 by the doctors surveyed in terms of meeting the optometrists' and their patients' overall needs. These doctors estimated that MicroLine could capture as much as 1/3 of the presbyopia pharmaceutical market, with the other 5 eye drops competing for the remaining 2/3 of the market.

我們最近對 100 名驗光師進行了市場調查，將 MicroLine 與 2025 年可能上市的 5 種現有或潛在的老花眼藥水進行了比較。這些醫生估計，MicroLine可以佔據老花眼藥品市場的1/3，另外5種眼藥水則爭奪剩餘的2/3的市場。

Should MicroLine be approved, we believe that the Optejet, with its design, ease-of-use and lower drug volume, distinguishes the product, and ultimately, patients other doctors will be choosing from a number of different eye drops or MicroLine, the one and only spray.

一旦 MicroLine 獲得批准，我們相信 Optejet 憑藉其獨特的設計、易用性和更少的藥量將使該產品脫穎而出，最終，其他醫生將在眾多眼藥水或唯一的噴霧劑 MicroLine 中進行選擇。

Turning to our partnering activities. We were very excited to announce in February a development collaboration agreement with Taiwan-based Formosa Pharmaceuticals. This agreement seeks to combine our Optejet with Formosa's unique APMT nanoparticle formulation platform for the potential development of new topical ophthalmic therapeutics that employ the Optejet device. Formosa's proprietary innovative APMT platform improves bioavailability and solubility of active pharmaceutical ingredients, allowing more homogenous formulations that may expand our universe with existing and future drugs that could benefit from delivery using the Optejet.

談到我們的合作活動。我們非常高興地在二月宣布與台灣的台塑製藥達成開發合作協議。該協議旨在將我們的 Optejet 與 Formosa 獨特的 APMT 奈米顆粒配方平台相結合，以便開發採用 Optejet 設備的新型局部眼科治療方法。 Formosa 專有的創新 APMT 平台提高了活性藥物成分的生物利用度和溶解度，從而允許更均質的配方，這可能會擴大我們的現有和未來藥物的範圍，這些藥物可能會受益於使用 Optejet 的輸送。

We believe this agreement with Formosa will open up new and large market indications for potential expansion of our pipeline and may serve as a model for future partnerships. We're continuing to advance discussions with potential partners that may benefit from Optejet within their own development programs such as glaucoma and dry eye. Co-development partnerships such as this, addressing large ophthalmic indications with unmet needs are a key part of our mid- and long-term growth strategy.

我們相信，與台塑達成的這項協議將為我們產品線的潛在擴展開闢新的廣大市場，並可成為未來合作的典範。我們將繼續與潛在合作夥伴進行討論，這些合作夥伴可能會在其青光眼和乾眼症等開發項目中受益於 Optejet。此類共同開發夥伴關係旨在解決尚未滿足的眼科疾病大面積適應症和醫療需求，是我們中長期成長策略的關鍵部分。

We are continuing to build a large body of data demonstrating the benefits of Optejet over conventional eye drops. In January, we announced positive results from a research study conducted in collaboration with Dr. Pedram Hamrah, Interim Chairman of Ophthalmology at Tufts Medical Center. This study evaluated the gene and protein expression of cytokines and chemokines after treatment with latanoprost, a glaucoma medication preserved with BAK administered via Optejet versus administered by standard eyedrops. In these early findings, the Optejet technology appears superior to standard eyedrops and reducing the inflammatory process.

我們正在繼續收集大量數據來證明 Optejet 相較於傳統眼藥水的優勢。今年 1 月，我們宣布了與塔夫茨醫學中心眼科臨時主席 Pedram Hamrah 博士合作進行的一項研究的積極成果。本研究評估了使用拉坦前列素治療後細胞激素和趨化因子的基因和蛋白質表現情況，拉坦前列素是一種用 BAK 保存的青光眼藥物，透過 Optejet 給藥與透過標準眼藥水給藥進行比較。在這些早期發現中，Optejet 技術似乎優於標準眼藥水並能減少發炎過程。

The Optejet was found to achieve a therapeutic dose of latanoprost with significantly less exposure to those excess drugs and harmful preservatives that can be achieved using conventional drops. These results were also presented at the Association for Research in Vision and Ophthalmology Annual Meeting last month.

研究發現，Optejet 能夠達到拉坦前列素的治療劑量，而且與使用傳統滴劑相比，其過量藥物和有害防腐劑的暴露量明顯減少。該結果也在上個月的視覺和眼科研究協會年會上發表。

At this point, I'd like to turn the call over to our Chief Operating Officer, Bren Kern, for our manufacturing update. Bren?

現在，我想將電話轉給我們的營運長布倫·科恩 (Bren Kern)，以了解我們的製造業最新情況。布倫？

Thank you, Michael. With FDA approval of MydCombi in hand, we've been working with our suppliers to finalize preparations for our upcoming MydCombi commercial launch. Material order plans are being finalized, and we are optimizing processes to align with requests made by the FDA during the review period. Our Redwood City facility, along with our contract manufacturers, continue to support our clinical partners, Bausch + Lomb and Arctic Vision, with clinical supplies being delivered regularly. Additionally, the Redwood City facility has made significant progress in qualifying our fill and finish line to support the Gen2 dispenser platform. This progress has instilled confidence to initiate the design of a high-capacity, automated fill and finish line, which would support our anticipated demand streams for the Gen2 device.

謝謝你，麥可。在獲得 FDA 對 MydCombi 的批准後，我們一直在與供應商合作，為即將推出的 MydCombi 商業發布做好最後準備。材料訂購計劃正在最終確定，我們正在優化流程以符合 FDA 在審查期間提出的要求。我們的紅木城工廠和合約製造商繼續支持我們的臨床合作夥伴博士倫和北極視覺，定期提供臨床用品。此外，雷德伍德城工廠在認證我們的填充和成品生產線以支援 Gen2 分配器平台方面取得了重大進展。這項進展使我們有信心啟動高容量、自動化填充和完成生產線的設計，這將支持我們對 Gen2 設備的預期需求流。

This state-of-the-art system should be installed in the second half of 2024, with additional qualifications occurring thereafter. Additionally, our Reno facility continues to make significant progress in establishing base and injector manufacturing. Recall, on our last earnings call, we noted the facility construction was ongoing. These activities have now been completed, and our Reno office staff has taken occupancy.

該最先進的系統預計將於 2024 年下半年安裝，隨後將進行額外的資格審查。此外，我們的里諾工廠在建立底座和噴油器製造方面繼續取得重大進展。回想一下，在我們上次的收益電話會議上，我們注意到設施建設正在進行中。這些活動現已完成，我們裡諾辦公室的工作人員已入職。

Production equipment is arriving, and installation and qualification activities will follow thereafter. Last quarter, we announced the addition of Enrico Brambilla as Eyenovia's Vice President of Product Research. Enrico joined us in April, and we are already leveraging his expertise and rapidly increasing our engineering capabilities through by identification of new hires, engineering tools and increased efficiencies, which will be leveraged across our dispenser and an array of drug products. I am genuinely excited about the significant amount of progress we have made over the last few months. Our operations capabilities are increasing on a daily basis. And the approval of MydCombi has successfully demonstrated our dispense platform is a viable technology solution to topical ophthalmic drug application.

生產設備正在抵達，隨後將進行安裝和鑑定活動。上個季度，我們宣布任命 Enrico Brambilla 為 Eyenovia 的產品研究副總裁。恩里科於四月加入我們，我們已經在利用他的專業知識，透過確定新員工、工程工具和提高效率來迅速提高我們的工程能力，這些將在我們的分配器和一系列藥品中得到利用。我對過去幾個月我們取得的重大進展感到由衷的興奮。我們的營運能力每天都在提高。 MydCombi 的核准成功證明了我們的配藥平台是局部眼科藥物應用的可行技術解決方案。

I'd now like to turn the call over to our Chief Financial Officer, John Gandolfo, to provide a financial update. John?

現在，我想將電話轉給我們的財務長約翰甘多夫 (John Gandolfo)，以提供財務最新情況。約翰？

Thanks, Bren. For the first quarter of 2023, net loss was approximately $5.7 million or $0.15 per share compared to a net loss of approximately $7.3 million or $0.24 per share for the first quarter of 2022.

謝謝，布倫。 2023 年第一季度，淨虧損約為 570 萬美元或每股 0.15 美元，而 2022 年第一季的淨虧損約為 730 萬美元或每股 0.24 美元。

Research and development expenses totaled approximately $2.5 million for the first quarter of 2023. This compares to approximately $3.7 million for the same period in 2022, a decrease of approximately 32%.

2023 年第一季的研發費用總計約 250 萬美元。

For the first quarter of 2023, general and administrative expenses were approximately $2.9 million compared with approximately $3.5 million for the first quarter of 2022, a decrease of approximately 15.5%.

2023 年第一季度，一般及行政費用約為 290 萬美元，而 2022 年第一季約為 350 萬美元，下降約 15.5%。

Total operating expenses for the first quarter of 2023 were approximately $5.5 million compared to total operating expenses of $7.2 million for the same period in 2022. This represents a decrease of approximately 24%.

2023 年第一季的總營運費用約為 550 萬美元，而 2022 年同期的總營運費用為 720 萬美元。

As of March 31, 2023, company's cash balance was approximately $18.5 million compared to $22.9 million as of December 31, 2022. In addition, the company has the ability to draw down an additional $5 million on its Avenue capital credit facility through July 31, 2023, based upon the recent approval of MydCombi.

截至 2023 年 3 月 31 日，公司的現金餘額約為 1850 萬美元，而截至 2022 年 12 月 31 日為 2290 萬美元。 此外，根據最近對 MydCombi 的批准，該公司有能力在 2023 年 7 月 31 日之前從其 Avenue 資本額中提取 50 萬美元信貸額度。

Licensing programs are an important source of current and potential future revenues for the company. And a major part of our strategy is to complete additional agreements as a source of nondilutive capital. In addition to the cash balance I noted above, we have a receivable from our license partners of approximately $975,000 as of March 31, 2023, and I expect a reimbursement payment of approximately $2 million from Arctic Vision for product development expenses in the second half of 2023.

許可計劃是公司當前和未來潛在收入的重要來源。我們策略的主要部分是完成額外協議作為非稀釋性資本的來源。除了我上面提到的現金餘額外，截至 2023 年 3 月 31 日，我們從許可合作夥伴處獲得的應收款項約為 975,000 美元，並且我預計 Arctic Vision 將在 2023 年下半年為產品開發費用報銷約 200 萬美元。

Before we open the call to questions, I will conclude with a brief update on our existing licensing programs with Bausch Health for MicroPine in the U.S. and Canada, and Arctic Vision for all 3 of our products in China and South Korea. MicroPine is a proprietary atropine formulation with a reduction of pediatric myopia progression. It has been shown in clinical studies to slow myopia progression by 60% or more. There are currently no FDA-approved drug therapies for this indication.

在我們開始提問之前，我將簡要介紹我們與 Bausch Health 在美國和加拿大就 MicroPine 達成的現有許可計劃，以及與 Arctic Vision 在中國和韓國就我們所有 3 種產品達成的現有許可計劃。 MicroPine 是一種專有的阿托品配方，可減緩兒童近視的進展。臨床研究表明，它可以將近視的發展減緩60％或更多。目前尚無 FDA 批准針對該症狀的藥物療法。

If left untreated, this can result in retinal detachment, myopic retinopathy and vision loss. Bifocal, multifocal glasses or contact lenses are typically prescribed to myopic children. Recall that as part of this agreement with Bausch + Lomb, costs related to the ongoing Phase III CHAPERONE clinical trial were transferred to our partner, and enrollment is progressing as planned. Our agreement with Arctic Vision covers Greater China and South Korea and covers MicroPine, MicroLine as well as MydCombi. So Arctic Vision is now licensing all 3 of our current programs in those territories.

如果不及時治療，可能會導致視網膜脫落、近視視網膜病變和視力喪失。通常，近視兒童需要配戴雙焦、多焦眼鏡或隱形眼鏡。回想一下，作為與博士倫達成的協議的一部分，正在進行的 III 期 CHAPERONE 臨床試驗的相關費用已轉移給我們的合作夥伴，並且招募工作正在按計劃進行。我們與 Arctic Vision 的協議涵蓋大中華區和韓國，涵蓋 MicroPine、MicroLine 以及 MydCombi。因此，Arctic Vision 目前正在這些地區授權我們目前的所有三個專案。

MicroPine for pediatric myopia in particular, represents a significant opportunity in China. The Ministry of Education estimates that nearly 53% of all Chinese children suffered from myopia in 2020. Our agreement with Arctic Vision provides us sales royalties in addition to development milestones. So if and when approved, MicroPine could be a significant source of non-dilutive funding for our company over the long term.

MicroPine 尤其適用於兒童近視治療，在中國有重大的市場機會。教育部估計，2020 年中國近 53% 的兒童患有近視。因此，如果獲得批准，MicroPine 可以成為我們公司長期重要的非稀釋性資金來源。

To date, our license agreements have generated approximately $16 million in license fees, and we have the potential to earn an additional $60 million in net license and development milestones as well as reimbursable expenses over the next 4 years.

迄今為止，我們的許可協議已產生約 1600 萬美元的許可費，並且我們有可能在未來 4 年內額外賺取 6000 萬美元的淨許可和開發里程碑以及可報銷費用。

Upon commercialization, if our products are approved, Eyenovia can earn significant sales royalties as well. We are also continuing to assess potential pipeline expansion opportunities such as our Formosa agreement as we believe we can continue to leverage the Optejet technology to address unmet needs in additional large ophthalmic indications. Pipeline expansion was a significant consideration as we were building our new manufacturing facilities.

如果我們的產品商業化後獲得批准，Eyenovia 也可以獲得可觀的銷售版稅。我們也正在繼續評估潛在的管道擴展機會，例如我們的 Formosa 協議，因為我們相信我們可以繼續利用 Optejet 技術來滿足其他大型眼科適應症中未滿足的需求。當我們建造新的製造設施時，管道擴建是一個重要的考慮因素。

In conclusion, we continue to be pleased with our performance to date. To summarize our key highlights today, we received FDA approval of MydCombi, a fixed-dose combination of tropicamide and phenylephrine mydriasis, and the first FDA-approved product to utilize the Optejet. We received feedback from FDA on a Phase III MicroLine presbyopia candidate that provides a clear and efficient path forward for the program that can potentially address a multibillion-dollar annual market in the U.S. alone. We announced a co-development agreement with Formosa Pharmaceuticals. Our manufacturing facility in Redwood City, California is operational. And our second facility in Reno, Nevada, is on track to be operational in the third quarter.

總而言之，我們對迄今為止的表現感到非常滿意。總結我們今天的重點，我們獲得了 FDA 批准的 MydCombi，它是托吡卡胺和苯腎上腺素散瞳劑的固定劑量組合，也是第一個獲得 FDA 批准的使用 Optejet 的產品。我們收到了 FDA 對第三階段 MicroLine 老花眼候選藥物的反饋，這為該項目提供了一條清晰而有效的前進道路，該項目可能僅在美國就能夠滿足每年數十億美元的市場需求。我們宣布與台塑製藥達成共同開發協議。我們位於加州雷德伍德城的製造工廠已投入營運。我們位於內華達州里諾的第二家工廠預計將於第三季投入營運。

We have continued to expand the body of research on Optejet, as shown by the results from our collaboration study with [Tops] that highlighted the significant potential of Optejet to bypass common adverse effects associated with chronic ophthalmic therapy use. And our licensing agreements with Arctic Vision and Bausch + Lomb are progressing well and continue to offer the opportunity for meaningful development and regulatory milestones as well as line of sight to potential sales royalties, possibly within 2 years.

我們不斷擴大對 Optejet 的研究範圍，與 [Tops] 合作研究的結果顯示，Optejet 在避免長期眼科治療常見不良反應方面具有巨大潛力。我們與 Arctic Vision 和 Bausch + Lomb 的授權協議進展順利，並將繼續為有意義的發展和監管里程碑提供機會，並為潛在的銷售特許權使用費提供前景，可能在 2 年內實現。

That concludes our prepared remarks. We would now like to open up 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) Our first question is from Matt Kaplan with Ladenburg Thalmann.

（操作員指示）我們的第一個問題來自 Ladenburg Thalmann 的 Matt Kaplan。

Congratulations on the approval of MydCombi. That was terrific news earlier this week.

祝賀MydCombi獲得批准。這是本週早些時候的好消息。

Thanks, Matt.

謝謝，馬特。

Can you talk a little bit about the commercial rollout? And you mentioned some of that in your prepared remarks, but how we should be thinking about that as we move to later this year and to next year?

能談談商業推廣的情況嗎？您在準備好的發言中提到了一些內容，但是，當我們進入今年晚些時候和明年時，我們應該如何考慮這些問題？

Yes, I'll take that. Thank you, Matt, very much. We're going to be rolling out later this summer. It's going to be a staged or a targeted rollout. The reason for that is that -- I'm actually here in our Reno facility right now, watching them installing lasers and ovens and other equipment. And it is much more cost efficient for us to be producing much of this on our own rather than using contract manufacturing. So we're going to have a targeted rollout to get the product out to some key offices later this summer. But the real push for MydCombi will come towards the end of this year, going into next year when we have our production facility here fully validated and running. So I would look at it as for this year, it's more to get it into the hands of some very key doctors and get the momentum building for it, collecting names on mydcombi.com, for example, and then we'll be able to turn everything next year.

是的，我接受。非常感謝，馬特。我們將於今年夏天晚些時候推出。這將是分階段或有針對性的推出。原因是——我現在就在我們裡諾的工廠裡，看著他們安裝雷射、烤箱和其他設備。對我們來說，自己生產大部分產品比使用合約製造更具成本效益。因此，我們將在今年夏天晚些時候有針對性地將產品推廣到一些主要辦事處。但 MydCombi 的真正推動力將在今年年底到來，到明年，屆時我們的生產設施將得到全面驗證並投入運作。因此我認為，就今年而言，我們更應該將其交到一些非常關鍵的醫生手中，並為其積聚勢頭，例如在 mydcombi.com 上收集姓名，然後我們就能在明年扭轉一切。

Great. And can you talk a little bit about pricing and how that's going to work out?

偉大的。您能否談談定價以及如何解決這個問題？

Yes. So price is $599 for 5 cartridges. So let's say, roughly $120 a cartridge. Each cartridge will support about 75 patients. So on a per patient basis, that's about $1.60. Right now, if you look what doctors are spending on the 3 eye drops, they're spending about $1.20. So it's a $0.40 increase, but the customers have told us that when they compare that against the time savings, the convenience and the overall better situation for their patients, they don't see that as being any hurdle for them to adopt it.

是的。因此 5 個墨盒的價格為 599 美元。因此，假設每個墨盒的價格約為 120 美元。每個墨盒可支援約 75 名患者。因此以每位病人計算，這筆費用約為 1.60 美元。現在，如果你看看醫生在 3 種眼藥水上的花費，他們花費大約為 1.20 美元。因此，費用增加了 0.40 美元，但客戶告訴我們，當他們將其與節省的時間、便利性和患者整體更好的狀況進行比較時，他們並不認為這會成為他們採用這項服務的任何障礙。

Okay. Great. And then just shifting gears a little bit. You mentioned that you received some positive feedback from the FDA on your MicroLine program. Can you give us some more details on that feedback and the path forward to the NDA registration?

好的。偉大的。然後稍微換一下檔位。您提到，您收到了 FDA 對 MicroLine 計劃的一些正面回饋。您能否向我們提供有關該回饋以及 NDA 註冊未來規劃的更多詳細資訊？

Right. So our and VISION-1 and VISION-2 studies were conducted in the same dispenser that MydCombi was approved in. And it's a great dispenser. It's perfect for the clinic. We want, however, for MicroLine to be more consumer-friendly, and therefore, we want to transition it to our Gen2, which is more slender and more portable, which fits together with that product. So our question to the FDA was basically, how do you get from Gen1 to Gen2 given that they have very similar characteristics in how they deliver the medication? The FDA gave us that information. It involves validating the device the same way we did for MydCombi. And the wonderful thing by having the MydCombi approval is we know exactly how to do that. And in fact, we're doing that right now.

正確的。因此，我們的 VISION-1 和 VISION-2 研究是在 MydCombi 核准的相同分配器中進行的。它非常適合診所。然而，我們希望 MicroLine 更方便消費者使用，因此，我們希望將其過渡到 Gen2，它更纖薄、更便攜，可以與該產品完美結合。因此，我們向 FDA 提出的問題是，鑑於它們在藥物傳遞方式上具有非常相似的特性，如何從 Gen1 過渡到 Gen2？ FDA 向我們提供了該資訊。它涉及以與我們對 MydCombi 相同的方式驗證設備。獲得 MydCombi 批准的奇妙之處在於我們確切地知道如何做到這一點。事實上，我們現在正在這樣做。

And the other thing they were looking for when I mentioned human factors, is they just wanted us to demonstrate that people can actually use the device, which we're also very confident about, because they have been using it. So there's a little formal study you have to do with that. So none of that is going to delay us. The -- really, the big pole in the tent is making the registration batches. And the only reason we can't make those sooner is because we have to make atropine batches for MicroPine for our partners at Bausch + Lomb and at Arctic Vision, because they have ongoing clinical studies that we need to make sure that we can supply in time.

當我提到人為因素時，他們尋找的另一件事是，他們只是希望我們證明人們確實可以使用該設備，我們對此也非常有信心，因為他們一直在使用它。所以你需要對此進行一些正式的研究。所以這些都不會耽誤我們。確實，帳篷裡的大桿子正在登記批次。我們無法提前生產這些藥物的唯一原因是，我們必須為我們的合作夥伴博士倫和北極視覺生產用於 MicroPine 的阿托品批次，因為他們正在進行臨床研究，我們需要確保能夠及時供應。

And can you just detail the time line to -- for those registration batches?

能詳細說明一下這些註冊批次的時間表嗎？

Yes. So we plan to have those registration batches very early next year and then 12 months of real-time stability. As soon as we get the stability results, we drop it into the NDA and off it goes.

是的。因此，我們計劃在明年年初完成這些註冊批次，然後實現 12 個月的即時穩定性。一旦我們獲得穩定性結果，我們就會將其放入保密協議 (NDA) 中並開始執行。

Great. Okay. And then final question -- questions. Can you give us kind of an update in terms of the progress that Bausch + Lomb and Arctic Vision have been making on their programs, specifically, the MicroPine program in the CHAPERONE Phase III?

偉大的。好的。然後是最後一個問題——問題。您能否向我們介紹博士倫和 Arctic Vision 計畫的最新進展，特別是 CHAPERONE 第三階段的 MicroPine 計畫？

So Bausch + Lomb had said publicly that they are intending to finish enrollment by the end of this year. When they do, it's 3 years to that -- the efficacy end point. Arctic Vision is going to be starting their study with the Generation 2 device as soon as we get that to them, which is later this year. I don't believe their study is 3 years. I think it's shorter than Bausch's. So both of these are probably going to finish up at roughly the same time.

因此博士倫曾公開表示，他們打算在今年底前完成招生。如果他們這樣做，就需要 3 年的時間才能達到療效終點。一旦我們將第二代設備交付給 Arctic Vision，他們就會開始使用該設備進行研究，具體時間是在今年稍後。我不相信他們的學習時間是3年。我認為它比 Bausch 的要短。因此這兩項工作可能都會在大約同一時間完成。

Our next question is from Matthew Caufield with H.C. Wainright.

下一個問題來自 H.C. 的 Matthew Caufield。溫賴特。

Great. Can you guys hear me okay?

偉大的。你們聽得到我說話嗎？

Yes, Matthew.

是的，馬修。

Awesome. Major congrats on the MydCombi approval, obviously. So I'm curious on the team's perspective on the seemingly negative sentiment from the stock following the approval. What do you think investors could have been missing or misinterpreting about the prospects for MydCombi or the Optejet opportunity overall? And then just separately, I was curious if you could -- if -- sorry, if further financing could prospectively be necessary tied to the internal MydCombi launch?

驚人的。顯然，我們對 MydCombi 的批准表示熱烈祝賀。因此，我很好奇團隊對於批准後股票看似負面的情緒的看法。您認為投資者可能忽略或誤解了 MydCombi 或 Optejet 的整體前景嗎？然後另外，我很好奇您是否可以——如果——抱歉，是否可能需要與內部 MydCombi 推出相關的進一步融資？

John, do you want to start with that one as it is a bit of a head scratcher?

約翰，你想從這個開始嗎？

Yes, sure. So from an overall financing -- it's a good question. So from an overall financing standpoint, we have multiple financing alternatives, including, as I mentioned, the Avenue Capital credit facility where we could draw down $5 million immediately. The reimbursement for clinical supplies from Bausch and Arctic Vision as well as partnership milestones or partnership or licensing opportunities, and we're pretty much working on all of these as of now. We also have traditional financing mechanisms in place.

是的，當然。因此從整體融資角度來看，這是一個好問題。因此，從整體融資角度來看，我們有多種融資選擇，包括我提到的 Avenue Capital 信貸額度，我們可以立即提取 500 萬美元。 Bausch 和 Arctic Vision 的臨床用品報銷以及合作里程碑或合作或許可機會，到目前為止，我們基本上正在處理所有這些問題。我們也擁有傳統的融資機制。

In terms of the financing for the MydCombi launch, we will not be building up a sales force. So there really is -- we don't expect our operating cash burn for the MydCombi launch really to be much different than it was last quarter, where we had an operating cash burn of roughly about $5.5 million.

就 MydCombi 發布的融資而言，我們不會建立銷售團隊。所以確實如此——我們預計 MydCombi 推出的營運現金消耗與上個季度相比不會有太大差別，上個季度我們的營運現金消耗約為 550 萬美元。

So we factored that into all of our cash projections. And we're constantly evaluating what alternatives we have in terms of financing going forward. But with our current cash resources, as well as the funds that we know we could draw down, we're pretty confident that we have sufficient cash through the second quarter into the third quarter of next year. So I hope that answers your question.

因此我們將其考慮到了所有現金預測。我們正在不斷評估未來融資方面有哪些替代方案。但憑藉我們目前的現金資源以及我們知道可以動用的資金，我們非常有信心在明年第二季到第三季有足夠的現金。我希望這能回答你的問題。

Yes. Matthew, I'd like to add because something else is -- I think there might be some people looking if you look at other companies or for the history of companies that they get the approval, and they put together a 100-person sales force and they start spending like crazy basically. And I've observed that at other companies, and I've seen that not work. And our philosophy here is we're not going to overcommit ourselves. We can get to our goals being extremely efficient. And as the product grows, we can add resources and add spend to go along with that to keep it almost like feeding the fire. So people may be concerned that with the approval that there's going to be this huge increase in commercial spend, that's not going to be the case.

是的。馬修，我想補充一點，因為還有一件事——我認為如果你看看其他公司或公司的歷史，可能會有人發現他們獲得了批准，組建了一支 100 人的銷售隊伍，然後開始瘋狂地花錢。我也在其他公司觀察過這種情況，發現這並不奏效。我們的理念是，我們不會做出太多的承諾。我們可以極其有效率地實現我們的目標。而隨著產品的成長，我們可以添加資源和支出，以此來維持產品的成長，就像火上加油一樣。因此人們可能會擔心，批准後商業支出會大幅增加，但事實並非如此。

Our next question is from [Jason McDonald], private investor.

我們的下一個問題來自私人投資者 [Jason McDonald]。

Yes. Just had a quick one. Kind of your last point there, Michael. When you talk about a hybrid organization, having some products in-house, and some being outsourced, of course, does the team really view the outsourcing of the technology as the bigger revenue generated an opportunity long term? I mean, obviously, you have to wait and see. But I'm just curious where your heads are at if you think that's really the long-term opportunity?

是的。剛剛快速吃了一頓。這是你的最後一點，麥可。當您談到混合型組織時，有些產品是內部生產，而有些則外包，那麼，團隊是否真的將技術外包視為可以創造更大收入的長期機會？我的意思是，顯然你必須拭目以待。但我只是好奇，如果您認為這真的是一個長期機會，您是怎麼想的？

Thank you, Jason, and thank you for being a shareholder and partner with us. Let me give an example. If we talk about the opportunity in glaucoma, there are many different segments in the glaucoma market. You could be a prostaglandin, you could be a beta blocker, you could be a ROCK inhibitor and so on. So one way to look at this is that by partnering with different companies that have different drugs in those segments, you can actually multiply the number of opportunities that we would have ourselves if we wanted to go into the glaucoma market with a product.

謝謝你，傑森，謝謝你成為我們的股東和夥伴。讓我舉個例子。如果我們談論青光眼領域的機遇，那麼青光眼市場有許多不同的部分。您可能是前列腺素，您可能是β受體阻斷劑，您可能是 ROCK 抑制劑等等。因此，看待這個問題的一種方式是，透過與在這些領域擁有不同藥物的不同公司合作，如果我們想帶著產品進入青光眼市場，你實際上可以增加我們自己擁有的機會數量。

So we are looking at some of these areas as ways that we can magnify the impact that we can have and get the Optejet out there. I mean it's good for patients, it's good for doctors, and it's good for you as a shareholder if we can get this use in more situations. Does that answer your question?

因此，我們正在研究這些領域，以擴大我們的影響力並讓 Optejet 走向市場。我的意思是，如果我們能在更多情況下實現這種用途，那麼這對病人有好處，對醫生有好處，對身為股東的您也有好處。這回答了你的問題嗎？

Yes, makes total sense.

是的，完全有道理。

Yes, if I can add on thing also. As we think about the structure, I think that we think about it more as a partnership type of opportunity where we could retain a really large portion of the economics as opposed to a straight-out license type agreement where you're giving up pretty much all of the upside. So I think, structurally, that's an important distinction to make as well.

是的，如果我也可以添加一些內容的話。當我們考慮這種結構時，我認為我們更多地將其視為一種合作類型的機會，我們可以保留很大一部分經濟利益，而不是直接的許可類型協議，在這種協議中你放棄了幾乎所有的好處。因此我認為，從結構上來說，這也是一個重要的區別。

Absolutely. And just a follow-up on to that point. When you -- when it comes to the expenses, long term, are you guys looking to keep this fairly small? Like you're saying, Michael, to go in not guns blazing, be careful with how you're kind of proceeding with these products to kind of see what the uptake is and maybe one works better than the other. Is that kind of the intent to stay agile in that sense?

絕對地。這只是對這一點的後續跟進。當談到長期開支時，你們是否希望將其保持在相當低的水平？就像你說的，邁克爾，不要大張旗鼓，要小心謹慎地處理這些產品，看看吸收情況如何，也許其中一種比另一種效果更好。從這個意義上來說，這是否是保持敏捷的意圖？

That is exactly it. So we will look and see, maybe 2 years from now, we might have 24 salespeople as we get ready to launch MicroLine. And when MicroLine takes off, we can add more, but we don't have to incur that expense today.

正是如此。因此，我們會觀察，也許兩年後，當我們準備推出 MicroLine 時，我們可能會有 24 名銷售人員。當 MicroLine 起飛時，我們可以添加更多，但我們不必今天就承擔這筆費用。

(Operator Instructions) Our next question is from [Robert Muse] with RN and Associates.

（操作員指示）我們的下一個問題來自 RN and Associates 的 [Robert Muse]。

Congratulations are in order. My question goes back to the financing that was brought up -- asked by the previous caller. Is it safe to say -- I know we all sustain financing that is over dilutive in nature. Is it safe to say you're not contemplating any dilutive financing secondary offering or anything in the near future, possibly not till maybe 2024?

我們值得祝賀。我的問題回到上一位來電者提出的融資問題。可以肯定地說——我知道我們都維持著本質上過度稀釋的融資。是否可以肯定地說，您沒有考慮在不久的將來進行任何稀釋性融資二次發行或任何活動，可能要到 2024 年？

Well, I think it's safe to say that what we're doing is we're evaluating all of the opportunities that are out there. We certainly -- I will tell you that whenever we think about financing the company, our main focus is to do it in the least dilutive fashion possible. So as I mentioned, we do have cash available over the short term from Avenue Capital facility as well as some other receivables that will be coming in. But we do a full in-depth analysis. So I don't want to say yes, I don't want to say no. But I will tell you that we do have a lot of optionality when it comes to our financing.

嗯，我認為可以肯定地說，我們正在做的是評估存在的所有機會。我們當然——我會告訴你，每當我們考慮為公司融資時，我們的主要重點是盡可能以最少稀釋的方式來進行。正如我所提到的，我們確實有來自 Avenue Capital 設施的短期現金以及一些其他應收款。所以我不想說是，也不想說不是。但我要告訴你，在融資方面我們確實有很多選擇。

Okay. But answer right now, you've made no decision to pursue any secondary dilutive offerings, is that correct?

好的。但現在回答一下，您還沒有決定進行任何二次稀釋性發行，對嗎？

Well, as of right now, we're evaluating all of the financing opportunities that we have with our partners and everything. But there's been no absolute firm decision on a capital raise.

嗯，截至目前，我們正在評估與合作夥伴的所有融資機會等等。但對於籌集資金的問題尚未做出絕對確定的決定。

Okay. And do you have -- I don't mean this to -- like beat a dead horse, but if you do decide on that, how far off into the future, would you think that would be?

好的。您是否——我並不是想——重複老生常談，但是如果您真的做出了決定，您認為那會是多遠的未來？

I haven't really thought about that at this point in time. I will tell you that we evaluate our alternatives constantly. So I don't want to commit to anything like that at this point in time.

我目前還沒有真正考慮過這個問題。我會告訴你，我們不斷評估我們的替代方案。所以目前我還不想承諾任何類似的事情。

All right. It's just a concern a lot of investors have that, I think I see that as the only hurdle for stopping someone to invest in your company is it's a factor. It is a factor. They don't want to invest in your company knowing that there's a secondary waiting to come to the market within a few weeks or a couple of months. It's an overhang. And if there was some assurance, there was no overhang, I'm sure everybody here would be a lot more bullish. And -- but I appreciate your answer. And do you have anything to add to that or no?

好的。很多投資人都擔心這一點，我認為阻止人們投資你的公司的唯一障礙就是這個因素。這是一個因素。他們不願意投資你的公司，因為他們知道在未來幾週或幾個月內就會有二級市場進入市場。這是一個懸垂部分。如果有保證，沒有任何懸而未決的問題，我相信這裡的每個人都會更樂觀。而且——但我很感謝您的回答。對此您還有什麼要補充嗎？

No. I think that's it, that we're constantly evaluating all of our alternatives.

不，我想就是這樣，我們一直在評估所有的替代方案。

Okay. But this would be probably the last one you'd want to use from -- I gather from what's been said so far.

好的。但從目前所說的內容來看，這可能是您最想使用的最後一個。

Let me -- John, if I can -- and correct me if I am wrong. Our strategy, among other things, is to develop partnerships, as John had mentioned. And those partnerships, obviously, would bring in some money associated with them. So things like that, that are nondilutive are absolutely our preference. So if you're looking, Robert, for what our preference is, it would be to close a partnership or 2, and we're working very hard on those and then do the nondilutive and save dilutive for the last option. John, would that be correct?

讓我——約翰，如果可以的話——糾正我，如果我錯了。正如約翰所提到的，我們的策略之一是發展合作關係。顯然，這些合作關係會帶來一些相關的資金收入。因此，類似這樣的、不具稀釋性的東西絕對是我們的首選。因此，羅伯特，如果你想知道我們的偏好是什麼，那就是結束一兩個合作關係，我們正在為這些合作關係而努力，然後採取非稀釋性措施，並將稀釋性措施留到最後的選擇。約翰，這樣對嗎？

Yes. Look, I think that -- I think you're trying to corner us into an answer. And what I'm telling you is that we look to, at all times, do things in the least dilutive fashion possible.

是的。瞧，我認為──我認為你正試圖逼迫我們給答案。我要告訴你們的是，我們始終致力於以盡可能不稀釋權益的方式開展工作。

Yes, I understand. And I'm glad that you've got capital to last you, as you said, until the first or second quarter of '24. So maybe there won't be a need to do this for a while anyway.

是的，我明白。我很高興你有足夠的資金，正如你所說，可以維持到24年第一季或第二季。因此，也許暫時沒有必要這樣做。

Thank you.

謝謝。

Thanks.

謝謝。

Our next question is from Len Yaffe with Stoc*Doc Partners.

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

Congrats on the development with MydCombi and all the other success, Michael, that you've enjoyed since you took over as CEO. It's a clear (technical difficulty) financing to build out the company for all the potential applications that you have, and that shouldn't be a surprise and it should be welcome. My question is, given that you've got a study, I believe, through topical that showed the superiority of Optejet versus drops in glaucoma, which are widely prescribed medications, MydCombi clearly seems to have benefit both in term (technical difficulty) they're incentive having to be both, separately and the ease of use and convenience. Could you discuss perhaps the size of the major ophthalmological markets such as glaucoma, where there might be partnership opportunities? Because I think not only would people be interested, but I would expect that the dollar size that would accrue to Eyenovia could be significant to overcome some of the concerns as expressed by the last caller.

邁克爾，祝賀 MydCombi 的發展以及您擔任執行長以來的所有其他成功。這顯然是一種（技術難度）融資，用於建立公司以適應所有潛在應用，這並不奇怪，而且應該受到歡迎。我的問題是，鑑於你們已經進行了一項研究，我相信，透過局部用藥證明了 Optejet 相對於廣泛使用的青光眼藥水而言具有優勢，MydCombi 顯然在兩個方面（技術難度）都具有優勢，它們的激勵機制必須同時具備，並且易於使用和方便。您能否討論一下青光眼等主要眼科市場的規模以及可能存在合作機會的地方？因為我認為人們不僅會感興趣，而且我預計 Eyenovia 所獲得的收入將相當可觀，足以克服上一位來電者所表達的一些擔憂。

Thank you, Len. So if we use glaucoma as an example, there are somewhere between 3 million and 4 million of glaucoma patients who are actually treated with topical medications in the United States. If you look at first-line therapy, it makes up about half of that, which I believe is about $1.5 billion last time I checked. Any good first-line branded medication in glaucoma should expect to make between $150 million and $300 million. And that's without really going crazy.

謝謝你，Len。因此，如果我們以青光眼為例，在美國，大約有 300 萬到 400 萬青光眼患者實際上接受局部藥物治療。如果你看看一線治療，它約佔其中的一半，我上次檢查時認為約為 15 億美元。任何治療青光眼的優質一線品牌藥物預計銷售額都應在 1.5 億至 3 億美元之間。這其實並不瘋狂。

Historically, they made more than that before many of them were genericized. So there are a number of partners out there who are looking at this opportunity and saying, this is meaningful for us, especially if we can convey all of these benefits to patients. And we didn't even mention the potential benefits of the Gen2 to the doctors, where you could track compliance and adherence because of the electronics that are embedded in the Optejet Gen2. So that's what we're looking at, and that's why we're interested in it. I think a good glaucoma medication and the Optejet can bring basically the whole package (technical difficulty) people that looked for in this market.

從歷史上看，在許多產品被仿製之前，它們的產量就超過了這個數字。因此，許多合作夥伴都在關注這個機會，並表示，這對我們來說意義重大，特別是如果我們能夠將所有這些好處傳達給患者。我們甚至還沒有提到 Gen2 為醫生帶來的潛在好處，透過 Optejet Gen2 中嵌入的電子設備，您可以追蹤依從性和依從性。這就是我們正在關注的，這也是我們對此感興趣的原因。我認為良好的青光眼藥物和 Optejet 基本上可以滿足人們在這個市場上尋找的整個方案（技術難度）。

Our next question is from [Alex Matthews] with -- he's a private investor.

我們的下一個問題來自 [Alex Matthews]——他是一位私人投資者。

Congratulations on the great achievement. I just want to find out about marketing of the product. I know I talked to my ophthalmologist, and he hadn't heard about the Optejet. So how do you plan to get the word out all the optometrists and ophthalmologists around the country?

祝賀您取得的巨大成就。我只是想了解該產品的營銷情況。我知道我和我的眼科醫生談過，但他沒有聽說過 Optejet。那麼您打算如何向全國各地的驗光師和眼科醫生宣傳這個消息呢？

Well, thank you, Alex, and I'm glad your doctor didn't hear about it because it would mean my marketing person was promotion ahead of when he should have been. But now that we are approved, the next step is we have to get materials approved through the FDA. That takes a few weeks. And then we will be reaching that various meetings through e-mail, through social media to go on to things like LinkedIn or Instagram. We have a big presence there. We will be able to get the news out. I think also when we start placing the product with some of these very highly visible offices, they all talk to each other, all of the doctors, they will all begin to see it.

好吧，謝謝你，亞歷克斯，我很高興你的醫生沒有聽說這件事，因為這意味著我的行銷人員提前晉升了。但是現在我們已經獲得批准，下一步就是必須透過 FDA 獲得材料批准。這需要幾週時間。然後，我們將透過電子郵件、社群媒體（如 LinkedIn 或 Instagram）參加各種會議。我們在那裡有很大影響力。我們將能夠傳播這個消息。我還認為，當我們開始將產品放置在一些非常顯眼的辦公室時，他們都會互相交談，所有的醫生都會開始看到它。

So the fact that your doctor doesn't know now, that's good. I would suspect that he or she will know 6 months from now about the product.

所以你的醫生現在不知道這一事實，這很好。我猜想他或她將在六個月後了解該產品。

We have reached the end of our question-and-answer session. I would like to turn the conference back over to Michael for closing comments.

我們的問答環節已經結束。我想將會議交還給邁克爾，請他作最後評論。

Thank you very much, operator. And thank all of you for joining us today, and that concludes today's call. We hope we have conveyed our excitement on our significant progress and outlook for the coming (technical difficulty). We have our first FDA approval in hand. And with the approval of MydCombi, our MicroLine presbyopia program is progressing. And we look forward to updating you on the manufacturing progress as well as discussions with potential future partners. So thank you again for joining us, and we look forward to our second quarter update later this year. Bye-bye.

非常感謝，接線生。感謝大家今天的參與，今天的電話會議到此結束。我們希望我們已經表達了我們對重大進展和未來（技術難題）展望的興奮之情。我們已獲得第一份 FDA 批准。並且隨著MydCombi的批准，我們的MicroLine老花眼計畫正在取得進展。我們期待向您通報製造進度以及與未來潛在合作夥伴的討論。再次感謝您的加入我們，我們期待今年稍後的第二季更新。再見。

Thank you. This does conclude today's conference. You may disconnect your lines at this time. And thank you for your participation.

謝謝。今天的會議到此結束。現在您可以斷開您的線路。並感謝您的參與。