Eyenovia Inc (EYEN) 2022 Q2 法說會逐字稿

Ladies and gentlemen, greetings, and welcome to the Eyenovia Second Quarter 2022 Earnings Conference Call. (Operator Instructions) As a reminder, this conference is being recorded.

女士們，先生們，大家好，歡迎來到 Eyenovia 2022 年第二季度收益電話會議。 （操作員說明）提醒一下，正在錄製此會議。

I will now turn the conference over to Eric Ribner of LifeSci Advisors. Please go ahead, sir.

我現在將會議轉交給 LifeSci Advisors 的 Eric Ribner。請繼續，先生。

Thanks very much, and good afternoon, and welcome to Eyenovia's Second Quarter 2022 Earnings Conference Call and Audio Webcast. With me today are Eyenovia's Chairman, Dr. Sean Ianchulev; Chief Executive Officer, Michael Rowe; and Chief Financial Officer, John Gandolfo.

非常感謝，下午好，歡迎來到 Eyenovia 的 2022 年第二季度收益電話會議和音頻網絡廣播。今天和我在一起的是 Eyenovia 的主席 Sean Ianchulev 博士；首席執行官邁克爾·羅；和首席財務官 John Gandolfo。

This afternoon, Eyenovia issued a press release announcing financial results for the 3 months ended June 30, 2022. We encourage everyone to read today's press release as well as Eyenovia's report on Form 10-K for the year ended December 31, 2021, which was filed with the SEC March 30, 2022, 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. In addition, this conference call is being webcast through the company's website and will be archived there for future reference.

今天下午，Eyenovia 發布了一份新聞稿，公佈了截至 2022 年 6 月 30 日止三個月的財務業績。我們鼓勵大家閱讀今天的新聞稿以及 Eyenovia 截至 2021 年 12 月 31 日止年度的 10-K 表格報告，該報告是2022 年 3 月 30 日向美國證券交易委員會提交，以及我們最近提交的 10-Q。公司的新聞稿和年度報告也可在 Eyenovia 的網站 www.eyenovia.com 上查閱。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。

Please note, on today's call, we will be discussing investigational products candidates, which have yet to receive FDA approval. 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 this 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.

請注意，在今天的電話會議上，我們將討論尚未獲得 FDA 批准的研究產品候選人。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，在此次電話會議期間，Eyenovia 的管理層將發表前瞻性聲明。由於與公司業務相關的風險和不確定性，實際結果可能與這些前瞻性陳述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 and most recently filed 10-Q. This conference call contains time-sensitive information accurate only as of the date of this live broadcast, August 10, 2022. 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 表格年度報告和最近提交的 10-Q 表格中有更詳細的描述。本次電話會議包含僅截至本次直播之日（2022 年 8 月 10 日）準確的時間敏感信息。Eyenovia 不承擔修改或更新任何前瞻性陳述以反映本次電話會議之後發生的事件或情況的義務，除非適用的證券法可能要求。

With that said, I'd like to turn the call over to Dr. Sean Ianchulev, Chairman of Eyenovia's Board of Directors. Sean?

話雖如此，我想把電話轉給 Eyenovia 董事會主席 Sean Ianchulev 博士。肖恩？

Thank you, Eric, and welcome, everyone, to our Second Quarter 2022 Financial Results Conference Call. I'll keep my comments very brief this morning before handing the call over to Eyenovia's new CEO, Michael Rowe, for a comprehensive update.

謝謝埃里克，歡迎大家參加我們的 2022 年第二季度財務業績電話會議。今天早上我會非常簡短地發表評論，然後將電話轉交給 Eyenovia 的新任首席執行官 Michael Rowe 進行全面更新。

In June, I announced that I would be stepping down from both the CEO and Chief Medical Officer roles and transitioning to Chairman of the Board, while also serving as a medical consultant to the company. At that time, the Board retained an executive search firm and conducted a broad search for the most qualified candidate. We identified several potential candidates and conducted interviews. At the end of the day, however, the Board agreed that none were better match for the skill set we require right now than Michael Rowe. The appointment of Michael, who previously served as our Chief Operating Officer, ensures continuity, while at the same time bringing significant diverse ophthalmic industry operations and commercialization expertise to the CEO role.

6 月，我宣布辭去首席執行官和首席醫療官的職務，轉任董事會主席，同時擔任公司的醫療顧問。當時，董事會聘請了一家獵頭公司，對最合格的候選人進行了廣泛的搜索。我們確定了幾位潛在候選人並進行了面試。然而，在一天結束時，董事會一致認為，沒有人比 Michael Rowe 更適合我們現在所需的技能。任命之前擔任我們首席運營官的邁克爾確保了連續性，同時為首席執行官一職帶來了重要的多元化眼科行業運營和商業化專業知識。

This is a critical moment given where we as a company stand today. We will be resubmitting our MydCombi new drug application in the fourth quarter, giving us line of sight to transitioning into a commercial stage company. At the same time, we're about to wrap up our second Phase III presbyopia study, VISION-2, which will be one input of MicroLine NDA for what we estimate to be a multibillion dollar presbyopia market in the U.S. alone.

鑑於我們公司今天所處的位置，這是一個關鍵時刻。我們將在第四季度重新提交我們的 MydCombi 新藥申請，讓我們有機會過渡到商業階段的公司。與此同時，我們即將結束我們的第二個 III 期老花眼研究 VISION-2，這將是 MicroLine NDA 的一項輸入，我們估計僅在美國就有數十億美元的老花眼市場。

Michael was also instrumental in brokering our collaborations with Bausch + Lomb, the eye care business that was spun out of Bausch Health in 2021, and Arctic Vision. Together, these agreements provide us with potential sources of non-dilutive funding in the form of development and regulatory milestones, and if the respective products are approved, sales royalties. This could be significant over time, and we see opportunities for additional agreements in other territories. Given Michael's track record here, the Board of Directors has also voted to add Michael as a board member, where we will be well served by his experience.

邁克爾還在促成我們與 Bausch + Lomb 的合作方面發揮了重要作用，Bausch + Lomb 是 2021 年從 Bausch Health 剝離出來的眼部護理業務，以及 Arctic Vision。總之，這些協議以開發和監管里程碑的形式為我們提供了潛在的非稀釋性資金來源，如果各自的產品獲得批准，則銷售特許權使用費。隨著時間的推移，這可能會很重要，我們看到了在其他地區達成更多協議的機會。鑑於 Michael 在這方面的往績，董事會還投票決定將 Michael 添加為董事會成員，他的經驗將為我們提供很好的服務。

With my transition to Chairman, I will be able to continue to work with the Board and leadership team to help guide Eyenovia towards its long-term goals while also remaining involved in future innovation as we work to expand our technology across additional therapeutic areas and cement our place as the new standard of care in topical ophthalmic therapies with the Optejet device. This is a very exciting time for Eyenovia. And with Michael assuming the CEO role, I believe we have a world-class team in place to best position us for long-term success. This will benefit not only patients and physicians, but our shareholders as well.

隨著我過渡到董事長，我將能夠繼續與董事會和領導團隊合作，幫助指導 Eyenovia 實現其長期目標，同時在我們努力將我們的技術擴展到更多治療領域和水泥時，我還將繼續參與未來的創新我們作為 Optejet 設備局部眼科治療新標準的地位。對於 Eyenovia 來說，這是一個非常激動人心的時刻。隨著邁克爾擔任首席執行官一職，我相信我們擁有一支世界一流的團隊，可以為我們的長期成功做好最佳準備。這不僅有利於患者和醫生，也有利於我們的股東。

Remaining on the topic of leadership, last month we announced that we added Drs. Ellen Strahlman and Ram Palanki as new directors to our Board of Directors. Each brings decades of medical technology, clinical development, launch and commercialization experience, much of it specific to ophthalmology. This cross-functional expertise rounds out what I believe to be a top quality board, especially at a time when we have these significant clinical and regulatory milestones rapidly approaching. That Ellen and Ram have agreed to join our Board provides strong validation of our technology, and I look forward to working with them and the entire Board as we shepherd the company through this new and exciting phase of growth.

關於領導力的話題，上個月我們宣布我們增加了 Drs。 Ellen Strahlman 和 Ram Palanki 擔任我們董事會的新董事。每個人都帶來了數十年的醫療技術、臨床開發、上市和商業化經驗，其中大部分都是針對眼科的。這種跨職能的專業知識完善了我認為是最高質量的董事會，尤其是在我們迅速接近這些重要的臨床和監管里程碑的時候。 Ellen 和 Ram 同意加入我們的董事會，這為我們的技術提供了強有力的驗證，我期待著與他們和整個董事會合作，共同帶領公司度過這個激動人心的新發展階段。

At this point, I'd like to pass the baton over to Michael.

在這一點上，我想把接力棒交給邁克爾。

Thank you, Sean, for the kind words. And thanks for everyone for joining our call this afternoon. I'm excited for this next chapter in Eyenovia's evolution, and I'm eager to take on my new responsibilities in moving our company forward and sustaining the positive momentum that we currently enjoy. I would like to thank you and the Board for the confidence that you are showing in me through these appointments.

肖恩，謝謝你的客氣話。感謝大家今天下午加入我們的電話會議。我對 Eyenovia 發展的下一章感到興奮，我渴望承擔新的責任，推動公司向前發展並保持我們目前享有的積極勢頭。我要感謝您和董事會通過這些任命對我表現出的信任。

So let's begin first with an update on our investigational mydriasis candidate MydCombi. We are very, very close to completing all of the Optejet device validation studies required by the FDA when MydCombi was reclassified to a drug device combination. We previously announced that 3 of 4 tests were completed successfully. Those included: a microbial challenge study that demonstrated the ability of the Optejet to keep microbes from entering the device; a human factor study, assessing the ability of users to follow cleaning instructions; and the electronic safety study. The fourth test, which is real-time drug stability, is ongoing and nearly complete. We expect results later this quarter.

因此，讓我們首先從我們的研究性散瞳候選人 MydCombi 的更新開始。當 MydCombi 被重新分類為藥物設備組合時，我們非常非常接近完成 FDA 要求的所有 Optejet 設備驗證研究。我們之前宣布 4 項測試中的 3 項已成功完成。其中包括：一項微生物挑戰研究，證明了 Optejet 防止微生物進入設備的能力；人為因素研究，評估用戶遵循清潔說明的能力；和電子安全研究。第四個測試是實時藥物穩定性，正在進行中並接近完成。我們預計本季度晚些時候會有結果。

We did experience modest supply chain delays that have impacted most high-technology manufacturers, and those have now been resolved. As a result, we now anticipate resubmitting our MydCombi NDA in the fourth quarter of this year. Reiterating the anticipated regulatory time line, we are assuming a 6-month review period and are making plans for a precision launch if approved during the first half of next year. And this launch time line is unchanged from our prior guidance. As we have said before, we believe the time and effort invested in this Optejet device validation work today may benefit and potentially streamline the review process for our other programs in the future, both MicroLine and MicroPine.

我們確實經歷了影響大多數高科技製造商的適度供應鏈延遲，這些延遲現在已經得到解決。因此，我們現在預計將在今年第四季度重新提交我們的 MydCombi NDA。重申預期的監管時間表，我們假設有 6 個月的審查期，如果在明年上半年獲得批准，我們正在製定精確啟動計劃。這個發佈時間表與我們之前的指導沒有變化。正如我們之前所說，我們相信今天在 Optejet 設備驗證工作上投入的時間和精力可能會受益，並有可能簡化我們未來其他項目（包括 MicroLine 和 MicroPine）的審查流程。

To ensure that we are fully capable of meeting the ongoing and new clinical product supply requirements of our partners, we recently announced that our new manufacturing facility in Redwood City, California, is now operational. The capacity and capabilities that we gained from this new state-of-the-art facility complements our existing contract manufacturing relationships. Facility is strategically located near several of our Silicon Valley-based suppliers and will be used primarily for Optejet manufacturing finishing operations, including drug loading, labeling and packaging prior to distribution.

為確保我們完全有能力滿足合作夥伴持續的和新的臨床產品供應要求，我們最近宣布我們位於加利福尼亞州雷德伍德城的新製造工廠現已投入運營。我們從這個新的最先進的設施中獲得的能力和能力補充了我們現有的合同製造關係。該設施戰略性地位於我們位於矽谷的幾家供應商附近，將主要用於 Optejet 製造精加工操作，包括藥物裝載、標籤和分銷前的包裝。

We also announced the hiring of medical technology industry veteran, Bren Kern, as Senior Vice President of Manufacturing Operations. Bren has spent his career helping companies transition from research and development entities into scaled commercial manufacturing organizations. Over the past 20 years, he has led product and manufacturing optimization, supported regulatory approvals and established GMP-compliant manufacturing solutions worldwide. We believe Bren brings to Eyenovia the ideal skill set and get-it-done attitude that we need as we prepare to make the important transition to a commercial stage company.

我們還宣布聘請醫療技術行業資深人士 Bren Kern 擔任製造運營高級副總裁。 Bren 的職業生涯一直致力於幫助公司從研發實體轉變為規模化的商業製造組織。在過去的 20 年裡，他領導了產品和製造優化，支持監管審批，並在全球範圍內建立了符合 GMP 標準的製造解決方案。我們相信 Bren 為 Eyenovia 帶來了理想的技能組合和實幹的態度，這是我們準備向商業階段公司進行重要過渡所需要的。

Now let's move to MicroLine, our proprietary Microdose Array Print pilocarpine therapy for the temporary improvement in near vision associated with presbyopia. 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，這是我們專有的微劑量陣列打印毛果芸香鹼療法，用於暫時改善與老花眼相關的近視力。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，他們從未戴過眼鏡並且有資源購買現金支付產品。

Our second Phase III study, VISION-2, is progressing nicely. As a reminder, VISION-2 is a double-masked superiority trial evaluating 2% multi-array print pilocarpine versus placebo. We are close to achieving full enrollment of subjects into the study and anticipate top line data this quarter. This is slightly later than our original guidance as we, as well as many other companies, found it challenging to get people out of their workspace for the required office visits. This is a consequence of the high employment rates that we currently enjoy. But we are approaching our target enrollment of 139, and this gives us confidence in the current time line.

我們的第二個 III 期研究 VISION-2 進展順利。提醒一下，VISION-2 是一項雙盲試驗，用於評估 2% 多陣列打印毛果芸香鹼與安慰劑的對比。我們即將實現受試者的全面註冊，並預計本季度的頂級數據。這比我們最初的指南稍晚，因為我們和許多其他公司發現，讓人們離開工作區進行必要的辦公室訪問具有挑戰性。這是我們目前享有的高就業率的結果。但我們正在接近 139 人的目標入學人數，這讓我們對當前的時間表充滿信心。

Today, there is currently 1 pharmacological treatment available on the market, Allergan's VUITY. And while this is helping to create the market, we believe we can capture a significant share of this market by leveraging the potential benefits of our Optejet technology. Among these is a low rate of headache. In VISION-1, we saw a very low rate of headache and brow ache, a common side effect of pilocarpine. Conventional pilocarpine drops can cause headache in about 15% of patients. With the Optejet, we saw this rate reduced to less than 3% in our VISION-1 trial. And so far, we are seeing the same profile coming out of VISION-2.

今天，市場上目前有 1 種藥物治療可用，艾爾建 (Allergan) 的 VUITY。雖然這有助於創造市場，但我們相信我們可以通過利用我們的 Optejet 技術的潛在優勢來佔領這個市場的重要份額。其中頭痛率較低。在 VISION-1 中，我們發現頭痛和眉痛的發生率非常低，這是毛果芸香鹼的常見副作用。常規毛果芸香鹼滴劑可導致約 15% 的患者頭痛。使用 Optejet，我們在 VISION-1 試驗中看到這一比率降低到 3% 以下。到目前為止，我們看到相同的配置文件來自 VISION-2。

In addition, MicroLine delivery through the Optejet dispenser is easier and neater to administer and is designed to be used on demand with far less ocular stresses caused by preservatives than traditional eye drops. Topical ophthalmic medications typically contain preservatives to help ensure the sterility of the product and to increase its shelf life. Over time, this can lead to adverse events due to the toxicity from overexposure to these preservatives. We have conducted studies, such as the one conducted in collaboration with Tufts University that we discussed last quarter, which have demonstrated that preserved drugs delivered with the Optejet act more like unpreserved drugs, reduce the ocular stress and potentially avoiding these long-term adverse events.

此外，通過 Optejet 分配器輸送的 MicroLine 給藥更容易、更整潔，並且設計用於按需使用，與傳統滴眼液相比，防腐劑引起的眼部壓力要小得多。局部眼科藥物通常含有防腐劑，以幫助確保產品無菌並延長其保質期。隨著時間的推移，由於過度接觸這些防腐劑會產生毒性，這可能會導致不良事件。我們進行了研究，例如我們上個季度討論的與塔夫茨大學合作開展的研究，該研究表明，使用 Optejet 輸送的防腐藥物更像未防腐藥物，可減輕眼部壓力並有可能避免這些長期不良事件.

We have compiled a significant body of market research among consumers, patients and prescribers, indicating strong interest in the Optejet over traditional eye droppers. In our most recent research conducted in the last 4 weeks, 94% of prescribers agreed with the statement that the Optejet will improve the drug delivery process for patients taking ophthalmic medications. This was based on the doctor's belief that the Optejet would improve the ability of patients to get the medication onto the eye and address issues that patients have with handling eye drop bottles or vials, tilting their head and dispensing too much medication.

我們對消費者、患者和開處方者進行了大量市場調查，表明對 Optejet 的濃厚興趣超過了傳統滴管。在我們過去 4 週進行的最新研究中，94% 的處方醫生同意 Optejet 將改善服用眼科藥物的患者的給藥過程這一說法。這是基於醫生的信念，即 Optejet 將提高患者將藥物滴到眼睛上的能力，並解決患者在處理眼藥水瓶或小瓶、傾斜頭部和分配過多藥物方面遇到的問題。

Similarly, 93% of consumers who regularly use eye drops also felt that the Optejet would give them more control or independence over eye medication use. The reasons behind this strong result were very much like those stated by the doctors. The totality of research that we have conducted give us a great deal of conviction that the Optejet can be a significant differentiator for us, potentially leading to strong consumer demand for our solutions relative to others on the market.

同樣，93% 經常使用眼藥水的消費者也認為 Optejet 可以讓他們更好地控製或獨立使用眼藥水。這一強勁結果背後的原因與醫生所說的非常相似。我們進行的全部研究讓我們堅信，Optejet 可以成為我們的重要差異化因素，與市場上其他解決方案相比，可能導致消費者對我們解決方案的強烈需求。

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, Michael. For the second quarter of 2022, we reported net loss of approximately $7.2 million,, or $0.22 per share, on approximately 33.6 million weighted average shares outstanding. And this compares to a net loss of approximately $4.8 million, or $0.19 per share, for the second quarter of 2021 on approximately 25.9 million weighted average shares outstanding.

謝謝你，邁克爾。 2022 年第二季度，我們報告約 3360 萬股加權平均流通股的淨虧損約為 720 萬美元，或每股 0.22 美元。相比之下，2021 年第二季度約 2590 萬股加權平均已發行股票的淨虧損約為 480 萬美元，或每股 0.19 美元。

Research and development expenses totaled approximately $3.6 million for the second quarter of 2022. This compares to approximately $3.7 million for the same period in 2021, a decrease of approximately 2.7%. For the second quarter of 2022, general and administrative expenses were approximately $3.5 million compared with approximately $2.3 million for the second quarter of 2021, an increase of approximately 53.8%.

2022 年第二季度的研發費用總計約為 360 萬美元。相比之下，2021 年同期約為 370 萬美元，下降了約 2.7%。 2022 年第二季度的一般和行政費用約為 350 萬美元，與 2021 年第二季度的約 230 萬美元相比增長了約 53.8%。

Total operating expenses for the second quarter of 2022 were approximately $7.1 million compared to total operating expenses of $6 million for the same period in 2021. This represents an increase of approximately 19%. As of June 30, 2022, the company's unrestricted and restricted cash balance was approximately $29.4 million, which includes $7.9 million of restricted cash.

2022 年第二季度的總運營費用約為 710 萬美元，而 2021 年同期的總運營費用為 600 萬美元。這增加了約 19%。截至2022年6月30日，公司不受限制和受限制的現金餘額約為2940萬美元，其中包括790萬美元的受限制現金。

Before we open the call to questions, I will conclude with a brief update on our licensing program for Bausch + Lomb for MicroPine in the U.S. and Canada and Arctic Vision for all 3 of our drugs in China and South Korea. It is worth noting that while our original license agreement in October 2020 was with Bausch Health, our U.S. licensee became Bausch + Lomb, the eyecare business that was formerly part of Bausch Health that was spun out as a separate company in early 2021. So for the sake of clarity, our U.S. licensee is Bausch + Lomb and not Bausch Health.

在我們開始提問之前，我將簡要介紹一下我們在美國和加拿大的 Bausch + Lomb 的 MicroPine 許可計劃以及 Arctic Vision 在中國和韓國的所有 3 種藥物的許可計劃。值得注意的是，雖然我們在 2020 年 10 月的原始許可協議是與 Bausch Health 簽訂的，但我們的美國被許可人變成了 Bausch + Lomb，這是一家眼部護理業務，以前是 Bausch Health 的一部分，於 2021 年初作為一家獨立的公司剝離出來。所以對於為清楚起見，我們的美國被許可人是 Bausch + Lomb，而不是 Bausch Health。

MicroPine, as you may recall, is a proprietary atropine formulation for the reduction of pediatric myopia progression that 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 and vision loss. Bifocal, multifocal glasses or contact lenses are typically prescribed to myopic children.

您可能還記得，MicroPine 是一種專有的阿托品製劑，用於減少兒童近視加深，臨床研究表明它可以將近視加深減緩 60% 或更多。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、近視性視網膜病變和視力喪失。雙焦點、多焦點眼鏡或隱形眼鏡通常用於近視兒童。

Recall that as part of the agreement with Bausch + Lomb, oversight and costs related to the ongoing Phase III CHAPERONE MicroPine clinical trial were transferred to our partner. CHAPERONE is a 48-month U.S.-based multicenter, randomized, double-masked trial that is enrolling more than 400 children between 3 and 12 years of age. The trial is comparing microdosed atropine 0.01% versus placebo ophthalmic solution, and enrollment is progressing as planned.

回想一下，作為與 Bausch + Lomb 達成的協議的一部分，與正在進行的 III 期 CHAPERONE MicroPine 臨床試驗相關的監督和費用已轉移給我們的合作夥伴。 CHAPERONE 是一項為期 48 個月的美國多中心、隨機、雙盲試驗，招募了 400 多名 3 至 12 歲的兒童。該試驗正在比較微劑量阿托品 0.01% 與安慰劑眼藥水，招募工作正在按計劃進行。

Our agreement with Arctic Vision covers Greater China and South Korea. And while the original agreement that we announced in August 2020 was for MicroPine and MicroLine, they also subsequently added MydCombi as well. 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 estimates that nearly 53% of all Chinese children suffered from myopia in 2020 and 13 million children are estimated to be at the highest risk. Our agreement with Arctic Vision provides for sales royalties in addition to development milestones. So if and when approved, MicroPine could be a significant source of non-dilutive funds to our company. Finally, we've recently announced that Arctic Vision has now enrolled the first patient in its presbyopia study. So that program is progressing nicely.

我們與 Arctic Vision 的協議涵蓋大中華區和韓國。雖然我們在 2020 年 8 月宣布的原始協議是針對 MicroPine 和 MicroLine 的，但他們隨後也添加了 MydCombi。因此，Arctic Vision 現在授權了我們所有 3 個當前項目。尤其是用於兒童近視的 MicroPine 在中國代表了一個重要的機會。教育部估計，到 2020 年，近 53% 的中國兒童患有近視，估計有 1300 萬兒童處於最高風險。除了開發里程碑之外，我們與 Arctic Vision 的協議還規定了銷售特許權使用費。因此，如果獲得批准，MicroPine 可能成為我們公司非稀釋性資金的重要來源。最後，我們最近宣布 Arctic Vision 現在已經在其老花眼研究中招募了第一位患者。所以該計劃進展順利。

Data 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 and reimbursable expenses over the next 4 years. As noted, upon commercialization, if approved, Eyenovia can also earn significant sales royalties as well. We are also continuing to assess potential pipeline expansion opportunities as we believe we can leverage the Optejet technology to address unmet needs in additional large ophthalmic indications. Some examples include anti-infectives, anti-inflammatories, dry eye and glaucoma, each with significant market opportunities. Pipeline expansion was a significant consideration as we were building out our new Redwood City, California facility.

數據許可協議產生了大約 1600 萬美元的許可費用，我們有可能在未來 4 年內額外獲得 6000 萬美元的淨許可和開發里程碑以及可報銷費用。如前所述，在商業化後，如果獲得批准，Eyenovia 也可以獲得可觀的銷售特許權使用費。我們還在繼續評估潛在的管道擴展機會，因為我們相信我們可以利用 Optejet 技術來解決其他大型眼科適應症中未滿足的需求。一些例子包括抗感染藥、抗炎藥、乾眼症藥和青光眼藥，每種藥都有巨大的市場機會。當我們在加利福尼亞州雷德伍德城建設新設施時，管道擴建是一個重要的考慮因素。

So in conclusion, we continue to be pleased with our performance to date. To summarize our key highlights today, one, we are continuing to rapidly advance our 3 Phase III MicroLine presbyopia program. And we are enrolling patients in our Phase III trial, VISION-2, and expect top line data in the third quarter. We are also actively preparing for the resubmission of our MydCombi NDA in the fourth quarter of this year, which if approved, would give us our first commercial product and validate our Optejet dispensing technology.

因此，總而言之，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，第一，我們將繼續快速推進我們的第三階段 MicroLine 老花眼計劃。我們正在為我們的 III 期試驗 VISION-2 招募患者，並預計第三季度的頂級數據。我們還積極準備在今年第四季度重新提交 MydCombi NDA，如果獲得批准，我們將獲得第一個商業產品並驗證我們的 Optejet 點膠技術。

We executed on a planned CEO transition and added significant expertise to our Board of Directors ahead of these meaningful clinical and regulatory milestones. Our new state-of-the-art manufacturing facility in Redwood City, California is now operational, and this provides additional capacity to complement our existing contract manufacturing relationships. And our license agreements with Arctic Vision and Bausch + Lomb were 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.

我們執行了計劃中的 CEO 交接，並在這些有意義的臨床和監管里程碑之前為我們的董事會增加了重要的專業知識。我們位於加利福尼亞州雷德伍德城的新的最先進的製造工廠現已投入運營，這提供了額外的能力來補充我們現有的合同製造關係。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 年內的潛在銷售特許權使用費提供機會。

So that concludes our prepared remarks. 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 comes from the line of Matt Kaplan from Ladenburg Thalmann.

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

Michael, congratulations on your new title.

邁克爾，祝賀你獲得新頭銜。

Thank you, Matt.

謝謝你，馬特。

Just in terms of, you mentioned a stage launch that was planned for MydCombi. Can you give us a sense of how that -- what that means and how that would roll out and why a stage launch?

就您而言，您提到了為 MydCombi 計劃的階段發布。您能否告訴我們這是如何進行的——這意味著什麼，將如何推出以及為什麼要分階段推出？

Yes. So our plan is approval the first half of next year. We'll be prepared within weeks after that approval to do the launch. But because it's a new technology, and we want to make sure that people have -- and the doctors, remember, this is geared for doctors, MydCombi -- have an optimal experience with the product. We're going to roll it out with large group practices that we can go and train them and learn everything we can. It's almost like a beta launch or a beta test, and get all the bugs out of that may be in the system because it is a new technology, a new way of doing things before going national. So I think what you'll see is that we are geared up to address about 10% of those offices with the current staffing and resources we have now. So we're not going to expend any additional money to do that. And once we have a bit of experience and have that under our belt, we'll expand after that.

是的。所以我們的計劃是明年上半年批准。我們將在批准發布後的幾週內做好準備。但因為這是一項新技術，我們希望確保人們——醫生，請記住，這是為醫生而設計的，MydCombi——對產品有最佳體驗。我們將通過大型團體實踐來推廣它，我們可以去培訓他們並學習我們所能學到的一切。這幾乎就像是 beta 發布或 beta 測試，並消除系統中可能存在的所有錯誤，因為它是一項新技術，一種在走向全國之前做事的新方法。因此，我認為您會看到，我們已準備好利用現有的人員配置和資源來解決這些辦公室中大約 10% 的問題。所以我們不會為此花費任何額外的錢。一旦我們有了一些經驗並掌握了這些經驗，我們就會在此之後進行擴展。

Okay. That's helpful. And then with respect to MicroLine and the VISION-2 study, as you're getting close to top line data there, what should we be looking for in the data as it comes out in the near term?

好的。這很有幫助。然後關於 MicroLine 和 VISION-2 研究，當你接近那裡的頂線數據時，我們應該在近期出現的數據中尋找什麼？

Well, the primary endpoint of course everybody will be looking at is the percentage of patients who have a 3-line gain in the active group versus the control group. So you'll be looking for a statistically significant result there. And then we want to see the adverse event profile. We've looked at the masked data in the trial so far overall where I said that the headache/brow ache was less than 3%. That's for everybody that's in there. So we're looking at the right profile. Assuming we have the efficacy, which would be part of the that top line, our plan then is to set up an end of Phase III meeting with the FDA, which takes about 60 days after that. go meet with the FDA. And coming out of that meeting, preparing to put together our NDA. And simultaneous with that, we'll start doing our registration batches for the NDA to save a little time.

好吧，當然每個人都會關注的主要終點是活性組與對照組相比獲得 3 線增益的患者百分比。因此，您將在那裡尋找統計上顯著的結果。然後我們想查看不良事件概況。到目前為止，我們總體上查看了試驗中的屏蔽數據，我說頭痛/眉痛不到 3%。那是給裡面的每個人的。所以我們正在尋找正確的配置文件。假設我們有療效，這將是該頂線的一部分，那麼我們的計劃是與 FDA 舉行 III 期會議結束，此後大約需要 60 天。去見FDA。會議結束後，準備整理我們的 NDA。與此同時，我們將開始為 NDA 進行註冊批處理，以節省一點時間。

And how long does it take to complete the registration batches?

完成註冊批次需要多長時間？

Well, the registration batches take a full year. So the sooner we can start that, the better. The trigger for that is the successful VISION-2. We'll go right into making those registration batches because they're not inexpensive, and we just want to be as efficient as possible.

好吧，註冊批次需要整整一年。所以我們越早開始越好。觸發因素是成功的 VISION-2。我們將直接進行這些註冊批次，因為它們並不便宜，我們只是希望盡可能高效。

(Operator Instructions) Our next question comes from the line of [Alex Matthews], an investor.

（操作員說明）我們的下一個問題來自投資者 [Alex Matthews]。

I want to find out if Optejet, when it's approved, it would be available for over-the-counter purchase, for regular use for dispensing drugs -- eye drops? And also, do you expect approval within 6 months, or it's going to take 6 months for approval?

我想知道 Optejet 在獲得批准後是否可以在櫃檯購買，是否可以定期用於配藥——眼藥水？另外，您希望在 6 個月內獲得批准，還是需要 6 個月才能獲得批准？

Yes. Alex, first of all, thank you for being an investor. We appreciate that. The Optejet is not something that you can fill with other products. It's not like you can take an eye dropper and squeeze it into the Optejet and use it. It actually is a primary container, which means it has to be developed with the drug that it's intended to use from the beginning. And that's why we have to do these registration studies. But with that, we are talking actively with other companies to see if they would like to put their products in our technology, and there is substantial interest. And one of our strategies is to partner or license the technology to these other companies so that we can see things in areas like dry eye or glaucoma, where other people might have very good drugs, but they don't have very good ways of having it dispensed. And if they marry with us, they could have the best of both worlds.

是的。亞歷克斯，首先，感謝你成為投資者。我們對此表示讚賞。 Optejet 不是您可以用其他產品填充的東西。這不像你可以拿一個眼藥水並將它擠入 Optejet 並使用它。它實際上是一個初級容器，這意味著它必須從一開始就用它打算使用的藥物來開發。這就是我們必須進行這些註冊研究的原因。但與此同時，我們正在與其他公司積極交談，看看他們是否願意將他們的產品應用到我們的技術中，並且有很大的興趣。我們的戰略之一是與這些其他公司合作或授權技術，以便我們可以在乾眼症或青光眼等領域看到一些東西，其他人可能有很好的藥物，但他們沒有很好的方法它分發了。如果他們和我們結婚，他們可以兩全其美。

For your second question, once we file -- refile the NDA for MydCombi, the clock for approval is 6 months at that point. Did I answer your question?

對於你的第二個問題，一旦我們提交——重新提交 MydCombi 的 NDA，批准的時間是 6 個月。我回答你的問題了嗎？

Yes.

是的。

Our next question comes from the line of Len Yaffe from Stoc*Doc Partners.

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

Sean, congratulations on having obsolesced yourself with an incredible successor. So you succeeded all around. My question for Michael is pretty simply. On the VUITY launch from Allergan, they started with a lot of commercials, and then the commercials, I think, stopped. But what have you learned from seeing the launch and from talking to optometrists or ophthalmologists in terms of the pluses and minuses of the product, what you might have learned that you could do better when you launch the product in the next year?

肖恩，恭喜你讓一位了不起的繼任者讓自己過時了。所以你成功了。我要問邁克爾的問題很簡單。在 Allergan 推出 VUITY 時，他們開始播放大量廣告，然後我認為廣告就停止了。但是，您從看到產品發布以及與驗光師或眼科醫生就產品的優缺點進行交談中學到了什麼，您可能學到什麼可以在明年推出該產品時做得更好？

Well, thank you, Len. And I'm going to correct your last name, Yaffe. Thank you for calling and for your support. The first thing we learned is that there's a tremendous interest in a pharmacological option for presbyopia. I think when Allergan went out the gate with the direct-to-consumer campaign, everybody was talking about it. Everybody was asking their doctors about it. So we've learned that the concept of having a pharmaceutical option for treating presbyopia is very, very high. So that's absolutely a positive. What we've also learned is that what we bring to the table in terms of having a better delivery system for people and one that addresses the side effect of brow ache and headache is also a very big positive, because that's the thing that people probably like the least about their products. So those were the 2 positives.

嗯，謝謝你，萊恩。我要更正你的姓氏，Yaffe。感謝您的來電和支持。我們了解到的第一件事是人們對老花眼的藥理學選擇有著極大的興趣。我認為當艾爾建推出直接面向消費者的活動時，每個人都在談論它。每個人都在問他們的醫生。所以我們了解到，擁有治療老花眼的藥物選擇的概念非常非常高。所以這絕對是積極的。我們還了解到，我們在為人們提供更好的輸送系統以及解決眉痛和頭痛的副作用方面帶來的好處也是一個非常大的積極因素，因為人們可能會這樣做最不喜歡他們的產品。所以這是 2 個優點。

The third thing that I think we've learned is how important it is to give doctors a heads up of what's coming out and who the right patients are for this product. For example, I have heard things like from other doctors who say they have 70-year-old patients who are coming into the office asking for it. And these products are really not designed for people like that. We've been very careful with what we've said, which has always been this is a product designed for people between 40 and 55, more or less freshly presbyopic, and that's really where they work best.

我認為我們已經了解到的第三件事是讓醫生了解即將發生的事情以及該產品的合適患者是多麼重要。例如，我從其他醫生那裡聽到類似的事情，他們說他們有 70 歲的病人來辦公室要求它。這些產品真的不是為這樣的人設計的。我們一直非常小心我們所說的，一直以來這是一款為 40 到 55 歲之間的人設計的產品，或多或少是新鮮的老花眼，而這正是他們最擅長的地方。

So I think what we've learned is really to set the right expectation, who the right patient is and what they can get out of this, which is good, functional vision. What most people between 40 and 55 are looking for is they'd like to be able to look at their cell phone without having to grab their glasses. It's that kind of function. They're not looking -- if they're teachers, they're not trying to grade term papers without their glasses on. So it's really setting the expectation of what you're going to get. And I think our product, frankly, offers the best answer for all of those 3 things.

所以我認為我們學到的是真正設定正確的期望，誰是合適的患者以及他們可以從中得到什麼，這是良好的功能性願景。大多數 40 到 55 歲之間的人正在尋找的是他們希望能夠在不戴眼鏡的情況下看手機。就是那種功能。他們不會看——如果他們是老師，他們不會試圖不戴眼鏡給學期論文打分。所以它真的設定了你將要得到的東西的期望。坦率地說，我認為我們的產品為所有這三件事提供了最佳答案。

And you mentioned that there were 18 million presbyops in the age range who...

你提到在這個年齡段有 1800 萬老花眼......

Who have money.

誰有錢。

Yes, who have money and are naive to glass wearing.

是的，誰有錢又天真地戴眼鏡。

Yes.

是的。

I was wondering what your expectations are for the revenue per patient per year so we could kind of arrive at a potential market size in the U.S.

我想知道您對每位患者每年的收入有何期望，以便我們可以得出美國的潛在市場規模。

Well, our market research has said that people -- with the Optejet specifically on average, a patient would probably fill that 3 times a year. And we had previously discussed that our price would be somewhere around $100 a cartridge. So that would give you an estimate of the revenue per patient.

好吧，我們的市場研究表明，人們——尤其是使用 Optejet 的患者，平均每年可能會填充 3 次。我們之前曾討論過，我們的價格約為每盒 100 美元。這樣你就可以估算出每位患者的收入。

Thank you. Ladies and gentlemen, we have reached the end of the question-and-answer session. And now I would like to turn the conference over to Mr. Michael Rowe, the Chief Executive Officer, for closing comments.

謝謝。女士們，先生們，我們的問答環節已經結束。現在，我想將會議轉交給首席執行官邁克爾·羅 (Michael Rowe) 先生髮表閉幕評論。

Thank you. And thank you, everybody. That concludes today's call. We hope we were successful in conveying the significant progress that we continue to make with the Optejet technology and across our key clinical programs. We remain on track to resubmit the MydCombi NDA in the fourth quarter of this year, and MicroLine presbyopia program is progressing with many clear and distinct advantages over therapies currently available or in development. Put simply, we believe we have potential line of sight to 2 commercial products in the near future. Thank you again for joining us.

謝謝。謝謝大家。今天的電話會議到此結束。我們希望我們成功地傳達了我們在 Optejet 技術和我們的關鍵臨床項目中繼續取得的重大進展。我們仍有望在今年第四季度重新提交 MydCombi NDA，而 MicroLine 老花眼項目正在取得進展，與目前可用或正在開發的療法相比，具有許多明顯和獨特的優勢。簡而言之，我們相信在不久的將來我們有可能看到 2 種商業產品。再次感謝您加入我們。

Thank you. The conference of Eyenovia has now concluded. Thank you for your participation. You may now disconnect your lines.

謝謝。 Eyenovia 會議現已結束。感謝您的參與。您現在可以斷開線路。