Eyenovia Inc (EYEN) 2022 Q4 法說會逐字稿

Greetings, and welcome to the Eyenovia Fourth Quarter and Full Year 2022 Earnings Call. (Operator Instructions) As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Eric Ribner with Investor Relations. Thank you, Eric. You may begin.

大家好，歡迎來到 Eyenovia 第四季度和 2022 年全年收益電話會議。 （操作員說明）提醒一下，正在錄製此會議。現在我很高興向您介紹投資者關係部的 Eric Ribner。謝謝你，埃里克。你可以開始了。

Thank you, and good afternoon, everyone, and welcome to Eyenovia's Fourth Quarter and Full Year 2022 Earnings Conference Call and Audio Webcast. With me today are Eyenovia's Chief Executive Officer; Michael Rowe; Chief Financial Officer, John Gandolfo; and Chief Operating Officer, Bren Kern.

謝謝，大家下午好，歡迎來到 Eyenovia 的第四季度和 2022 年全年收益電話會議和音頻網絡廣播。今天和我在一起的是 Eyenovia 的首席執行官；邁克爾·羅；首席財務官 John Gandolfo；和首席運營官 Bren Kern。

This afternoon, Eyenovia issued a press release announcing financial results for the 3 and 12 months ended December 31, 2022. We encourage everyone to read today's press release as well as Eyenovia's annual report on Form 10-K for the year ended December 31, 2022, which will be filed with the SEC on March 31, 2023, tomorrow and our most recently filed 10-Q. The company's press release and annual report are also available on Eyenovia's website at www.eyenovia.com.

今天下午，Eyenovia 發布了一份新聞稿，公佈了截至 2022 年 12 月 31 日止的第 3 個月和第 12 個月的財務業績。我們鼓勵大家閱讀今天的新聞稿以及 Eyenovia 截至 2022 年 12 月 31 日止年度的 10-K 表格年度報告，將於明天 2023 年 3 月 31 日和我們最近提交的 10-Q 向美國證券交易委員會提交。公司的新聞稿和年度報告也可在 Eyenovia 的網站 www.eyenovia.com 上查閱。

In addition, this conference call is being webcast through 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, which have yet to receive FDA approval.

此外，本次電話會議正在通過公司網站進行網絡直播，並將在那裡存檔以備將來參考。請注意，在今天的電話會議上，我們將討論尚未獲得 FDA 批准的研究候選產品。

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.

另請注意，今天電話會議上討論的某些信息包含在《私人證券訴訟改革法》的安全港條款中。我們提醒聽眾，在電話會議期間，Eyenovia 的管理層將發表前瞻性陳述。由於與公司業務相關的風險和不確定性，實際結果可能與這些前瞻性陳述明示或暗示的結果存在重大差異。

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. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, March 30, 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.

這些前瞻性陳述受到許多風險的影響，這些風險在我們的 10-K 表格年度報告中有更詳細的描述。本次電話會議包含僅截至本次直播之日（2023 年 3 月 30 日）準確的時間敏感信息。Eyenovia 不承擔任何修改或更新任何前瞻性陳述以反映本次會議之後發生的事件或情況的義務調用，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?

話雖如此，我想把電話轉給 Eyenovia 的首席執行官 Michael Rowe。邁克爾？

Thank you, Eric, and welcome, everyone, to our fourth quarter and full year 2022 financial results conference call. I will start with an update on our overall strategy and our current development programs. and then Bren Kern, our Chief Operating Officer, will provide an update on our manufacturing and commercial readiness progress.

謝謝埃里克，歡迎大家參加我們的第四季度和 2022 年全年財務業績電話會議。我將從更新我們的總體戰略和當前的發展計劃開始。然後我們的首席運營官 Bren Kern 將提供有關我們製造和商業準備進度的最新信息。

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.

然後我們將把事情交給我們的首席財務官 John Gandolfo，他將審查財務狀況以及我們與 Bausch + Lomb 和 Arctic Vision 的合作夥伴關係。然後我們將打開您的問題的電話。

The fourth quarter caps a successful year for Eyenovia as we delivered on all of our key milestones. We resubmitted our MydCombi New Drug Application, or NDA, and its review by FDA is well underway. In fact, earlier this week, I was at our Reno manufacturing facility while the FDA inspection was taking place. We completed the VISION-2 study for our MicroLine Presbyopia program and recently received very encouraging feedback from the FDA providing a clear path forward for the program.

第四季度為 Eyenovia 成功的一年畫上了句號，因為我們實現了所有關鍵里程碑。我們重新提交了我們的 MydCombi 新藥申請或 NDA，FDA 正在對其進行審查。事實上，本週早些時候，當 FDA 檢查正在進行時，我在我們的里諾製造工廠。我們完成了 MicroLine 老花眼計劃的 VISION-2 研究，最近收到了來自 FDA 的非常鼓舞人心的反饋，為該計劃提供了一條清晰的前進道路。

Our time line for MicroLine is as we had planned, and we look forward to providing more granularity in the coming weeks. Regarding our manufacturing, we made substantial progress building out our in-house capabilities, which will be key to our longer-term growth initiatives. Subsequent to the end of the quarter, we also participated in the Consumer Electronics Show in Las Vegas with a very innovative boot highlighting our work in digital health, that we believe significantly raised awareness of the Optejet. And we announced a co-development agreement with Formosa Pharmaceuticals that will open the door to the development of new therapeutics that leverage our technology.

我們的 MicroLine 時間表與我們的計劃一致，我們期待在未來幾週內提供更多細節。在我們的製造方面，我們在建立內部能力方面取得了實質性進展，這將是我們長期增長計劃的關鍵。本季度末，我們還參加了在拉斯維加斯舉行的消費電子展，推出了一款非常創新的靴子，突出了我們在數字健康方面的工作，我們相信這大大提高了 Optejet 的知名度。我們還宣布了與 Formosa Pharmaceuticals 的共同開發協議，這將為開發利用我們技術的新療法打開大門。

But before we talk about our current programs, I'd like to spend a few moments discussing our longer-term strategy. As you probably noticed, we recently have been focusing more on the Optejet technology and its applicability in areas like digital health, glaucoma and dry eye. We believe that incorporating the Optejet technology with late-stage drugs in chronic disease areas like glaucoma could result in new therapies that can address many of the major challenges with today's conventional eye drop options. The horizontal delivery of the Optejet, for example, can make it easier for patients to reliably use our medication. Digital technology could help prescribers and health care systems understand how drugs are being used and drive prescribing decisions from a position of knowledge rather than guesswork.

但在我們談論我們當前的計劃之前，我想花點時間討論一下我們的長期戰略。您可能已經註意到，我們最近更加關注 Optejet 技術及其在數字健康、青光眼和乾眼症等領域的適用性。我們相信，將 Optejet 技術與青光眼等慢性疾病領域的晚期藥物相結合，可能會產生新療法，解決當今傳統滴眼液選擇面臨的許多主要挑戰。例如，Optejet 的水平輸送可以使患者更容易可靠地使用我們的藥物。數字技術可以幫助開處方者和醫療保健系統了解藥物的使用方式，並根據知識而不是猜測來推動處方決策。

And the lower dose volumes and ease of use of the Optejet can help address tolerability issues that can also impact long-term outcomes of drug therapy. With that in mind, we are focusing our future efforts on partnerships with drug developers such as Formosa to bring together the best available combination of drugs in the Optejet for the benefit of patients, prescribers and payers.

Optejet 較低的劑量體積和易用性有助於解決耐受性問題，這些問題也會影響藥物治療的長期結果。考慮到這一點，我們將未來的工作重點放在與 Formosa 等藥物開發商的合作夥伴關係上，以便將 Optejet 中可用的最佳藥物組合結合起來，造福於患者、處方者和付款人。

And speaking of combinations, let's talk now about MydCombi. MydCombi is our proprietary combination microdose formulation of tropicamide and phenylephrine for in-office and presurgical pupil dilation. In December, we announced the FDA had accepted our NDA for MydCombi and the signs of PDUFA action date of May 8, 2023. This was a significant achievement for our company given the additional testing of the Optejet device requested by FDA, following its reclassification of MydCombi to a drug-device combination product in October 2021.

說到組合，現在讓我們談談 MydCombi。 MydCombi 是我們專有的托吡卡胺和去氧腎上腺素組合微劑量製劑，用於診室和術前瞳孔散大。 12 月，我們宣布 FDA 已接受我們對 MydCombi 的 NDA 和 PDUFA 行動日期為 2023 年 5 月 8 日的跡象。鑑於 FDA 要求對 Optejet 設備進行額外測試，這對我們公司來說是一項重大成就，在其重新分類後MydCombi 於 2021 年 10 月成為藥物-器械組合產品。

As I previously mentioned, we are now in the midst of the review process, including an inspection of one of our manufacturing facilities , and we remain in close contact with the agency. I would like to take a moment to thank all of the Eyenovia employees as well as the many technical experts who have helped to get us this far and we are counting the 39 days until May 8.

正如我之前提到的，我們現在正處於審查過程中，包括對我們的一個製造設施進行檢查，我們與該機構保持密切聯繫。我想花點時間感謝 Eyenovia 的所有員工以及幫助我們走到這一步的許多技術專家，我們正在計算 5 月 8 日之前的 39 天。

It is also worth noting that much of the device validation testing that we conducted for the MydCombi NDA may be referenceable in filings for future programs, potentially streamlining those regulatory review processes. MydCombi, if approved, represents a very meaningful milestone for Eyenovia for several reasons. One, it is poised to be our first commercial product, ultimately transitioning us to a commercial stage and revenue-generating company, but perhaps more importantly, it would represent critical validation of our proprietary Optejet device technology potentially changing the paradigm in the way that topical eye drugs are developed and delivered. We are leveraging Optejet not only with our own development pipeline, but also current and potential future strategic partnerships as well. We currently have partnerships with Arctic Vision for the development of MydCombi, MicroLine and MicroPine in Greater China and South Korea and Bausch + Lomb for the development of MicroPine in the U.S. and Canada. And we are actively working on partnerships for chronic ophthalmic diseases such as Glaucoma and Dry Eye.

還值得注意的是，我們為 MydCombi NDA 進行的大部分設備驗證測試可能會在未來計劃的文件中作為參考，從而有可能簡化這些監管審查流程。 MydCombi 如果獲得批准，對於 Eyenovia 來說是一個非常有意義的里程碑，原因有幾個。第一，它有望成為我們的第一個商業產品，最終將我們轉變為商業階段和創收公司，但也許更重要的是，它將代表我們專有的 Optejet 設備技術的關鍵驗證，可能會以局部方式改變範式開發和交付眼藥。我們不僅利用我們自己的開發管道，而且還利用當前和未來潛在的戰略合作夥伴關係來利用 Optejet。目前，我們與 Arctic Vision 建立合作夥伴關係，在大中華區和韓國開發 MydCombi、MicroLine 和 MicroPine，並與 Bausch + Lomb 建立合作夥伴關係，在美國和加拿大開發 MicroPine。我們正在積極致力於青光眼和乾眼症等慢性眼科疾病的合作夥伴關係。

John will provide an update on our current partnerships during his financial overview.

John 將在他的財務概覽中提供我們當前合作夥伴關係的最新信息。

Let's now turn to MicroLine, which is our proprietary topical on-demand pilocarpine-based therapeutic candidate that we are developing for the temporary improvement in near vision associated with Presbyopia. Presbyopia is the age-related hardening of the eye's 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, who otherwise never wore glasses and have the resources for a cash pay product.

現在讓我們轉向 MicroLine，這是我們專有的局部按需毛果芸香鹼治療候選藥物，我們正在開髮用於暫時改善與老花眼相關的近視力。老花眼是眼睛晶狀體與年齡相關的硬化，導致近距離視力模糊。這是一個可尋址的市場，僅在美國就有超過 1800 萬年齡在 40 到 55 歲之間的人，他們從不戴眼鏡並且有資源購買現金支付產品。

In terms of dollars, our proprietary market research suggests this could be nearly a $1 billion annual market in the U.S. alone. As I previously mentioned, following completion of our VISION-2 trial, we recently received encouraging feedback from the FDA, which outlines a very clear path forward for the program towards an NDA. We can't share much more at the moment other than to say that our development timeline is unchanged, and we plan to provide further updates in the coming weeks as warranted.

就美元而言，我們專有的市場研究表明，僅在美國，這可能是一個近 10 億美元的年度市場。正如我之前提到的，在我們的 VISION-2 試驗完成後，我們最近收到了來自 FDA 的令人鼓舞的反饋，其中概述了該計劃走向 NDA 的非常明確的前進道路。目前我們不能分享更多，只能說我們的開發時間表沒有改變，我們計劃在未來幾週內根據需要提供進一步的更新。

MicroLine would clearly be differentiated from other Presbyopia eye drop options. First of all, it has demonstrated compelling safety and tolerability. In both VISION-1 and 2, MicroLine was found to be very well tolerated, with fewer than 3% of MicroLine treated subjects reporting adverse events, all of which were considered mild and transient. This compares very favorably to other pilo-based Presbyopia treatments where 15% or more of study subjects reported some form of headache or browache.

MicroLine 明顯有別於其他老花眼滴眼液。首先，它已經證明了令人信服的安全性和耐受性。在 VISION-1 和 2 中，發現 MicroLine 的耐受性非常好，只有不到 3% 的 MicroLine 治療受試者報告了不良事件，所有這些都被認為是輕微和短暫的。這與其他基於 pilo 的老花眼治療相比非常有利，在其他基於 pilo 的老花眼治療中，15% 或更多的研究對象報告有某種形式的頭痛或胸痛。

Additionally, as a drug device combination and maybe that MicroLine better fits in the business paradigm of optometrists, many of whom also supply glasses and contact lenses for their patients, we are exploring ways in which the device portion of the product could be stocked and stored by eye care practitioners so that they can provide a full service for their patients that could include eyeglasses as well as MicroLine.

此外，作為一種藥物設備組合，也許 MicroLine 更適合驗光師的業務模式，其中許多人還為他們的患者提供眼鏡和隱形眼鏡，我們正在探索產品的設備部分可以儲存和存儲的方式由眼保健醫生提供，以便他們可以為患者提供全面服務，包括眼鏡和 MicroLine。

In summary, we believe the Optejet represents a key point of differentiation that can set us apart and will resonate with consumers and their doctors as compared to other recently approved topical Presbyopia treatments and those to come in the future.

總而言之，我們認為 Optejet 代表了一個關鍵的差異化點，它可以使我們與眾不同，並且與最近批准的其他外用老花眼治療和未來的治療相比，將引起消費者及其醫生的共鳴。

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

轉向我們的合作活動。就在幾週前，我們非常高興地宣布與總部位於台灣的 Formosa Pharmaceuticals 達成新的開發合作協議。該協議旨在將我們的 Optejet 與 Formosa 獨特的 APNT 納米顆粒製劑平台結合起來。用於潛在開發使用 Optejet 設備的新型局部眼科療法。 Formosa 專有和創新的 APNT 平台減小了活性藥物成分的粒徑並提高了其溶解度，從而允許更均勻的配方，這可能會擴大現有和未來藥物的範圍，這些藥物可能會受益於使用 Optejet 的交付。

We intend to work together on testing formulations and engaging in discussions with the FDA with the goal of executing a development and commercializations agreement that will see new molecules develop, leveraging Formosa formulation technology in the Optejet. We believe this agreement with Formosa can serve as the model for future partnerships. And to that end, we are in active discussions with additional parties that may benefit from the Optejet within their own development programs. Co-development partnerships such as this and large ophthalmic indications with unmet needs are a key part of our long-term growth strategy. We have built a significant body of data demonstrating the benefits of Optejet over conventional eye drops.

我們打算在測試配方方面共同努力，並與 FDA 進行討論，以執行開發和商業化協議的目標，該協議將看到新分子的開發，利用 Optejet 中的 Formosa 配方技術。我們相信與 Formosa 的這項協議可以作為未來合作夥伴關係的典範。為此，我們正在與可能在自己的開發計劃中受益於 Optejet 的其他各方進行積極討論。諸如此類的共同開發合作夥伴關係以及未滿足需求的大型眼科適應症是我們長期增長戰略的關鍵部分。我們建立了大量數據，證明 Optejet 優於傳統滴眼液。

In January, we added to this by announcing 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 of protein expression of cytokines and chemokines after treatment with latanoprost, the glaucoma medication preserved with BAK administered via Optejet versus administered via standard eye drops.

今年 1 月，我們還宣布了與塔夫茨醫學中心眼科臨時主席 Pedram Hamrah 博士合作開展的一項研究的積極結果。本研究評估了拉坦前列素治療後細胞因子和趨化因子蛋白表達的基因，拉坦前列素是通過 Optejet 給藥與通過標準滴眼液給藥的青光眼藥物。

It is common to use preservatives to support product sterility and prolonged shelf life. Unfortunately, patients treated with BAK preserved glaucoma medications often suffer inflammatory side effects and subsequent -- and develop subsequent ocular surface disease.

通常使用防腐劑來支持產品無菌和延長保質期。不幸的是，接受 BAK 保存性青光眼藥物治療的患者經常會出現炎症副作用和隨後的——並發展為隨後的眼表疾病。

In this most recent study, human conjunctival cells were used to evaluate 3 RNA markers that signal inflammatory response in groups treated with latanoprost plus BAK by an the Optejet versus standard eye drops. And 2 out of 3 cases, cells treated via the Optejet head markers decreased that was statistically similar to preserving a free latanoprost delivered by a standard eyedrops and the control.

在這項最近的研究中，人類結膜細胞被用來評估 3 種 RNA 標記物，這些標記物在用 Optejet 和標準滴眼液用拉坦前列素加 BAK 治療的組中發出炎症反應信號。 3 例中有 2 例通過 Optejet 頭部標記物處理的細胞減少，這在統計學上類似於保留由標準滴眼液和對照遞送的游離拉坦前列素。

In these early findings, the Optejet technology appears better than latanoprost plus BAK administered via standard eyedrops in reducing inflammatory processes. This is a very important finding, particularly as we look at using the Optejet in dry eye or glaucoma where medication has taken over an extended period of time.

在這些早期發現中，Optejet 技術在減少炎症過程方面似乎優於通過標準滴眼液施用的拉坦前列素加 BAK。這是一個非常重要的發現，尤其是當我們在乾眼症或青光眼中使用 Optejet 治療藥物已服用很長時間時。

For the Optejet, it appears that these harmful and unwanted side effects can be significantly reduced. At this point, I'd like to turn the call over to our Chief Operating Officer, Bren Kern, for a manufacturing update. Bren?

對於 Optejet，這些有害和不需要的副作用似乎可以顯著減少。在這一點上，我想將電話轉給我們的首席運營官 Bren Kern，以獲取製造更新。布倫？

Thanks, Michael. In anticipation of FDA approval of MydCombi, Eyenovia has been focused on our production capabilities. We view the ability to build and fill the Optejet as a key element of our growth strategy going forward and we have made significant progress in developing world-class capabilities to this end. Recall that in July, we announced at our manufacturing facility in Redwood City, California, became operational and is currently manufacturing clinical supply. That facility is focused on Optejet manufacturing finishing operations, including drug loading, labeling and packaging prior to distribution.

謝謝，邁克爾。在 MydCombi 獲得 FDA 批准的預期中，Eyenovia 一直專注於我們的生產能力。我們將建造和填充 Optejet 的能力視為我們未來發展戰略的關鍵要素，為此我們在開發世界級能力方面取得了重大進展。回想一下，7 月份，我們宣布我們位於加利福尼亞州雷德伍德城的製造工廠開始運營，目前正在製造臨床用品。該設施專注於 Optejet 的製造精加工操作，包括藥物裝載、貼標籤和分銷前的包裝。

Our second facility in Reno, Nevada is progressing as planned, with construction activities currently in process and manufacturing equipment orders and deliveries being finalized. We anticipate this facility being operational this summer. This facility, when complete, will focus on the production of proprietary Optejet components in the durable portion of the Optejet dispenser, the base. We, along with many other companies, across a very broad range of industries, did experience supply chain delays and challenges due to COVID and believe these global challenges are beginning to ease.

我們在內華達州里諾的第二個工廠正在按計劃進行，目前正在進行施工活動，製造設備訂單和交付也已完成。我們預計該設施將於今年夏天投入運營。該工廠建成後，將專注於在 Optejet 分配器的耐用部分（底座）中生產專有的 Optejet 組件。我們和許多其他行業的公司一樣，確實經歷了 COVID 造成的供應鏈延誤和挑戰，我們相信這些全球挑戰正在開始緩解。

We have increased our capabilities through the addition of new hires, whose mandate is to scale and strengthen our supply chain. These changes have resulted in significant improvement in the Optejet availability for both our internal development programs as well as for our partners, the benefits of which are already being realized.

我們通過增加新員工來提高我們的能力，他們的任務是擴大和加強我們的供應鏈。這些變化顯著改善了 Optejet 對我們內部開發計劃以及合作夥伴的可用性，其好處已經實現。

This is another advantage of having proprietary manufacturing capabilities. It gives us a level of control over the processes so that we can ensure the quality and consistency that our current and future partners expect for us.

這是擁有專有製造能力的另一個優勢。它使我們能夠對流程進行一定程度的控制，以便我們能夠確保當前和未來合作夥伴對我們期望的質量和一致性。

Collectively, our new state-of-the-art facilities and increased capabilities of our suppliers provide us with the capacity and operational redundancy to reliably produce products, not only for commercial supply, if and when the products are approved, but also for our internal development programs, clinical trials, partnerships and co-development agreements.

總的來說，我們最先進的新設施和供應商能力的增強為我們提供了可靠生產產品的能力和運營冗餘，不僅用於商業供應（如果產品獲得批准），還用於我們的內部開發計劃、臨床試驗、合作夥伴關係和共同開發協議。

To further support our development programs, Eyenovia is pleased to announce the acceptance of an offer by Enrico Brambilla as Eyenovia's Vice President of Product Research and Development. Enrico holds a Masters of Science in Mechanical Engineering from the University of Politecnico in Milan and will be joining Eyenovia the second week of April. The majority of Enrico's 20-year career has been focused on the development of medical device products. Prior to joining Eyenovia, Enrico served as a Vice President at Equinox Ophthalmic and held technical leadership roles at Breathe Technologies, ResMed and Electrolux home appliances.

為了進一步支持我們的開發計劃，Eyenovia 很高興地宣布接受 Enrico Brambilla 擔任 Eyenovia 產品研發副總裁的提議。 Enrico 擁有米蘭理工大學的機械工程理學碩士學位，並將於 4 月的第二週加入 Eyenovia。 Enrico 20 年職業生涯的大部分時間都專注於醫療器械產品的開發。在加入 Eyenovia 之前，Enrico 曾擔任 Equinox Ophthalmic 的副總裁，並在 Breathe Technologies、ResMed 和 Electrolux home appliances 擔任技術領導職務。

In his new role, Enrico will be leading our engineering team, supporting our existing product lines as well as leading the development of new innovations. I'm excited to have Enrico in this role and look forward to the numerous contributions he will provide to Eyenovia.

在他的新職位上，Enrico 將領導我們的工程團隊，支持我們現有的產品線並領導新創新的開發。我很高興 Enrico 擔任這個職位，並期待著他為 Eyenovia 做出的眾多貢獻。

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

我現在想將電話轉給我們的首席財務官 John Gandolfo，以提供財務更新。約翰？

Thank you, Bren. With respect to our 2022 P&L results, we recorded no license revenue during the fourth quarter or full year of 2022. By comparison, we recorded license revenue of $10 million and $14 million for the fourth quarter and full year 2021, respectively, from our partnerships with Bausch and Arctic Vision. For the fourth quarter of 2022, we reported net loss of approximately $6.1 million or $0.17 per share on approximately 36.7 million weighted average shares outstanding and this compares to a net income of approximately $3 million or $0.11 per share for the fourth quarter of 2021 on approximately 27.9 million weighted average shares outstanding.

謝謝你，布倫。關於我們 2022 年的損益結果，我們在 2022 年第四季度或全年沒有記錄任何許可收入。相比之下，我們在 2021 年第四季度和全年分別從我們的合作夥伴那裡獲得了 1000 萬美元和 1400 萬美元的許可收入與 Bausch 和 Arctic Vision 合作。 2022 年第四季度，我們報告約 3670 萬股加權平均流通股的淨虧損約為 610 萬美元或每股 0.17 美元，相比之下，2021 年第四季度的淨收入約為 300 萬美元或每股 0.11 美元2790萬股加權平均流通股。

For the full year 2022, we reported net loss of approximately $28 million or $0.83 per share on approximately 33.6 million weighted average shares outstanding, and this compares to a net loss of approximately $12.8 million or $0.49 per share for the full year of 2021 on approximately 26.3 million weighted average shares outstanding.

2022 年全年，我們報告約 3360 萬股加權平均流通股的淨虧損約為 2800 萬美元或每股 0.83 美元，相比之下，2021 年全年的淨虧損約為 1280 萬美元或每股 0.49 美元，約2630萬股加權平均流通股。

Research and development expenses totaled approximately $2.2 million in the fourth quarter of 2022, and this compares to approximately $3.3 million for the same period of 2021, a decrease of 33%. For the full year 2022, research and development expenses decreased approximately 10% to $13.4 million versus $14.9 million for the full year 2021. The full year decrease was driven primarily by lower direct clinical and nonclinical expenses, as well as deferral of costs related to the future delivery of clinical supply to our license partners.

2022 年第四季度研發費用總計約為 220 萬美元，與 2021 年同期的約 330 萬美元相比下降了 33%。 2022 年全年，研發費用減少約 10% 至 1340 萬美元，而 2021 年全年為 1490 萬美元。全年減少的主要原因是直接臨床和非臨床費用減少，以及與未來向我們的許可合作夥伴提供臨床供應。

For the fourth quarter of 2022, general and administrative expenses were approximately $3.2 million compared with approximately $3.7 million for the fourth quarter of 2021, a decrease of 13.3%. For the full year 2022, G&A expenses were $13.5 million, an increase of 28% as compared to $10.6 million for the full year 2021. The full year increase was driven by staff additions, higher professional fees and an increase in stock-based compensation.

2022 年第四季度，一般和行政費用約為 320 萬美元，而 2021 年第四季度約為 370 萬美元，下降 13.3%。 2022 年全年的 G&A 費用為 1,350 萬美元，與 2021 年全年的 1,060 萬美元相比增長了 28%。全年增長的原因是員工增加、專業費用增加以及股票薪酬增加。

Total operating expenses for the fourth quarter of 2022 were approximately $5.4 million compared to total operating expenses of $6.9 million for the same period in 2021. This represents a decrease of approximately 22.7%. Total operating expenses for the full year 2022 were $26.9 million, representing an increase of 6% versus $25.4 million for the full year 2021.

2022 年第四季度的總運營費用約為 540 萬美元，而 2021 年同期的總運營費用為 690 萬美元。這減少了約 22.7%。 2022 年全年的總運營費用為 2690 萬美元，與 2021 年全年的 2540 萬美元相比增長了 6%。

As of December 31, 2022, company's cash balance was approximately $22.9 million in all unrestricted cash. We believe our current cash balance as of today is sufficient to fund the company's operations as currently planned well into the second quarter of 2024.

截至 2022 年 12 月 31 日，公司所有非限制性現金的現金餘額約為 2290 萬美元。我們相信，我們目前的現金餘額足以為公司目前計劃的 2024 年第二季度運營提供資金。

Before we open the call to questions, I will conclude with a brief update on our licensing programs were Bausch + Lomb 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 for the 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, and if left untreated, this can result in retinal detachment, myopic retinopathy as well as vision loss.

在我們開始提問之前，我將簡要介紹一下我們的許可計劃，即美國和加拿大的 MicroPine 的 Bausch + Lomb 以及中國和韓國的所有 3 種產品的 Arctic Vision。 MicroPine 是一種專有的阿托品配方，用於減少小兒近視的發展。臨床研究表明，它可以減緩 60% 或更多的近視進展。目前尚無 FDA 批准的用於該適應症的藥物療法，如果不及時治療，可能會導致視網膜脫離、近視性視網膜病變以及視力喪失。

Bifocal, multifocal glasses or contact lenses are typically prescribed to myopic children. Recall that as part of our agreement with Bausch + Lomb, oversight and costs related to the ongoing Phase III CHAPERONE MicroPine clinical trial, we transferred to our partner. Enrollment is progressing as planned.

雙焦點、多焦點眼鏡或隱形眼鏡通常用於近視兒童。回想一下，作為我們與 Bausch + Lomb 協議的一部分，與正在進行的 III 期 CHAPERONE MicroPine 臨床試驗相關的監督和費用，我們轉移給了我們的合作夥伴。招生工作正在按計劃進行。

Our agreement with Arctic Vision covers Greater China and South Korea and covers MicroPine, MicroLine and MydCombi. So Arctic Vision now licenses all 3 of our current programs. MicroPine for pediatric myopia, in particular, represents a significant opportunity in China. The Ministry of Education there estimates that nearly 53% of all Chinese children suffered from myopia in 2020. Our agreement with Arctic Vision provides a sales royalties in addition to development milestones. So if and when approved, MicroPine could be a significant source of nondilutive funds for our company over the long term.

我們與 Arctic Vision 的協議涵蓋大中華區和韓國，涵蓋 MicroPine、MicroLine 和 MydCombi。因此，Arctic Vision 現在授權了我們所有 3 個當前項目。特別是用於兒童近視的 MicroPine 在中國代表了一個重要的機會。那裡的教育部估計，到 2020 年，近 53% 的中國兒童患有近視。我們與 Arctic Vision 的協議除了提供開發里程碑外，還提供了銷售版稅。因此，如果獲得批准，從長遠來看，MicroPine 可能成為我們公司非稀釋性資金的重要來源。

And finally, Arctic Vision continues to enroll patients in its Presbyopia study. This marks the first time that the clinical trial has been approved in China to evaluate pharmacologic treatment for Presbyopia. So that program is also progressing nicely.

最後，Arctic Vision 繼續招募患者參與其老花眼研究。這標誌著該臨床試驗首次在中國獲批，以評估老花眼的藥物治療效果。因此，該計劃也進展順利。

To date, our license agreements have generated approximately $16 million on 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 萬美元的許可費用，我們有可能在未來 4 年內獲得額外的 6000 萬美元淨許可和開發里程碑以及可報銷費用。

As noted upon commercialization, if these products are approved, Eyenovia can also 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 and additional large ophthalmic indications. Pipeline expansion was a significant consideration as we were building our new manufacturing facilities.

正如在商業化時指出的那樣，如果這些產品獲得批准，Eyenovia 也可以獲得可觀的銷售版稅。我們還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 技術來解決未滿足的需求和其他大型眼科適應症。在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 our NDA for MydCombi has been accepted by the FDA, and we have a PDUFA date of May 8. We are reviewing the feedback that we recently received from FDA on our MicroLine program, and we believe the agency has outlined a clear path forward for the program, and we plan to provide additional updates in the near future. This program is also progressing according to plan. We announced the co-development agreement with Formosa Pharmaceuticals. Our new state-of-the-art manufacturing facility in Redwood City, California, is operational and our second facility in Reno is on track to be operational in the summer time frame.

總之，我們對迄今為止的表現仍然感到滿意。總結我們今天的主要亮點，我們的 MydCombi NDA 已被 FDA 接受，我們的 PDUFA 日期為 5 月 8 日。我們正在審查我們最近從 FDA 收到的關於我們的 MicroLine 計劃的反饋，我們相信該機構已經概述為該計劃指明了前進的道路，我們計劃在不久的將來提供更多更新。這個項目也在按計劃進行。我們宣布了與台塑製藥的共同開發協議。我們位於加利福尼亞州雷德伍德城的最先進的新製造工廠已投入運營，我們在里諾的第二家工廠有望在夏季投入運營。

We have recruited a new Vice President of Product Research and Development, which should help ensure that our technology remains at the forefront of the industry. And our license 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 the next 2 years.

我們招聘了一位新的產品研發副總裁，這應該有助於確保我們的技術保持在行業的最前沿。我們與 Arctic Vision 和 Bausch + Lomb 的許可協議進展順利，並繼續為有意義的開發和監管里程碑以及可能在未來 2 年內實現潛在銷售特許權使用費提供機會。

That now concludes our prepared remarks, and we would now like to open up the call to questions. Operator?

我們準備好的發言到此結束，我們現在想開始提問。操作員？

(Operator Instructions) Our first question is from Matt Kaplan with Ladenburg Thalmann.

（操作員說明）我們的第一個問題來自 Matt Kaplan 和 Ladenburg Thalmann。

This is [Raymond] in for Matt. Congrats on all the progress. I guess just want to ask on MydCombi. You mentioned that there's an ongoing inspection. I was wondering -- could you comment potentially on when you think labeling discussion might start? And I have another question.

這是馬特的 [Raymond]。祝賀所有的進步。我想只是想在 MydCombi 上問問。你提到正在進行檢查。我想知道——您能否就您認為標籤討論何時開始發表評論？我還有一個問題。

Yes. The inspection is going on right now as part of the NDA review in our Reno facility. If everything goes as expected, labeling discussions usually don't happen until about 10 days before the PDUFA date. So I don't expect that we would hear anything about the label until the very end of April.

是的。作為我們里諾工廠 NDA 審查的一部分，檢查正在進行中。如果一切按預期進行，標籤討論通常要到 PDUFA 日期前大約 10 天才會發生。所以我不希望我們在 4 月底之前聽到有關該標籤的任何消息。

Okay. Appreciate that color. I guess -- and also, I guess, just to follow up on that, potentially on the commercial preparations. I was wondering, once you get final approval, how long do you think you'll be able to launch after approval?

好的。欣賞那種顏色。我想——而且，我想，只是為了跟進，可能是在商業準備方面。我想知道，一旦獲得最終批准，您認為批准後多久可以啟動？

Well, we are going to provide more information about that in the upcoming weeks, especially as we get more clarity on what the label looks like, for example, but our plans now are that we would like to be out there this summer in -- very early in the third quarter. So that's the current commercial plan.

好吧，我們將在接下來的幾週內提供更多相關信息，尤其是當我們更清楚地了解標籤的外觀時，例如，但我們現在的計劃是我們希望在今年夏天在那裡 -第三季度很早。這就是當前的商業計劃。

Okay. And just one final question on MicroLine perhaps. I know you can't talk too much about it, but -- and you got some good feedback, encouraging feedback and your time line is busier. I was wondering, does that give you confidence on how you can move forward on manufacturing?

好的。也許只是最後一個關於 MicroLine 的問題。我知道你不能談論太多，但是——你得到了一些很好的反饋，令人鼓舞的反饋，而且你的時間線更忙了。我想知道，這是否讓您對如何推進製造業充滿信心？

Yes. There was -- yes, it does give us -- we now have greater clarity on exactly what we need to do. And so we're putting those plans into place. And I look forward again in the upcoming weeks once we have into place and sharing more information on that time line. But everything is positive from what we received back and as expected.

是的。有——是的，它確實給了我們——我們現在更清楚地知道我們需要做什麼。因此，我們正在實施這些計劃。我再次期待在接下來的幾週內，一旦我們確定並分享有關該時間線的更多信息。但從我們收到的回復和預期的情況來看，一切都是積極的。

There are no further questions at this time. I would like to turn the floor back over to Michael Rowe for closing comments.

目前沒有其他問題。我想將發言權轉回給 Michael Rowe 發表結束評論。

Okay. Thank you very much, and that concludes today's call. Our goal was to share with you those key events over the last few months that have led us to the potential approval of MydCombi in May. MydCombi's approval is important, not just because it's our first commercial product, but because it demonstrates that our unique Optejet technology, which underpins all of our products to meet the high standards of the FDA.

好的。非常感謝，今天的電話會議到此結束。我們的目標是與您分享過去幾個月中導致我們可能在 5 月批准 MydCombi 的那些關鍵事件。 MydCombi 的批准很重要，不僅因為它是我們的第一個商業產品，還因為它證明了我們獨特的 Optejet 技術支持我們所有的產品滿足 FDA 的高標準。

We look forward to making significant progress with MicroLine as we validate our manufacturing process for the in-home device and continue to engage in meaningful discussions with potential partners to leverage that [by] glaucoma and dry eye. And with that, I thank all of you. We will talk again in May for our next quarterly update. Thank you.

我們期待與 MicroLine 取得重大進展，因為我們驗證了家用設備的製造工藝，並繼續與潛在合作夥伴進行有意義的討論，以利用青光眼和乾眼症。就此，我感謝你們所有人。我們將在 5 月再次討論我們的下一個季度更新。謝謝。

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

今天的電話會議到此結束。此時您可以斷開線路。感謝您的參與。