Eyenovia Inc (EYEN) 2023 Q3 法說會逐字稿

Good day, ladies and gentlemen, and welcome to Eyenovia third quarter of 2023 earnings conference call. (Operator Instructions). As a reminder, this conference is being recorded. I will now turn the call over to Blaine comments. Please go ahead, sir.

女士們先生們，美好的一天，歡迎參加 Eyenovia 2023 年第三季財報電話會議。 （操作員說明）。提醒一下，本次會議正在錄製中。我現在將把電話轉給布萊恩評論。請繼續，先生。

Thank you, Judith, and good afternoon, and welcome everybody to Eyenovia Third Quarter 2023 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.

謝謝朱迪思，下午好，歡迎大家參加 Eyenovia 2023 年第三季財報電話會議和音訊網路廣播。今天與我在一起的有 Eyenovia 執行長 Michael Rowe、財務長 John Gandolfo 和營運長 Bren Kern。

This afternoon, we issued a press release announcing financial results for the three months ended September 30, 2023. We encourage everybody to read today's press release as well as Eyenovia's quarterly report on Form 10-Q for the quarter ended September 30, 2023, which will be filed with the SEC tomorrow, November 14, and our most recently filed Form 10-K.

今天下午，我們發布了一份新聞稿，宣布截至2023 年9 月30 日的三個月的財務業績。我們鼓勵大家閱讀今天的新聞稿以及Eyenovia 的截至2023 年9 月30 日的季度10-Q表格季度報告，其中將於明天（11 月 14 日）向 SEC 提交，以及我們最近提交的 10-K 表格。

The company's press release and annual report are also available on our website at www.eyenovia.com. In addition, this conference call is being webcast at the company's website and will be archived there for future reference. Please note that on today's call, we will be discussing product concepts, some candidates, some of which have yet to receive FDA approval.

該公司的新聞稿和年度報告也可在我們的網站 www.eyenovia.com 上取得。此外，本次電話會議正在公司網站上進行網路直播，並將存檔以供日後參考。請注意，在今天的電話會議上，我們將討論產品概念和一些候選產品，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 Provision of the Private Securities Litigation Reform Act. We caution listeners that during the call, Eyenovia's management will be making forward-looking statements. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are subject to a number of risks which are described in more detail in our annual report on Form 10-K.

另請注意，今天電話會議中討論的某些資訊受《私人證券訴訟改革法》的安全港條款管轄。我們提醒聽眾，在電話會議期間，Eyenovia 的管理層將做出前瞻性聲明。由於與公司業務相關的風險和不確定性，實際結果可能與這些前瞻性陳述中明示或暗示的結果有重大差異。這些前瞻性陳述面臨許多風險，我們的 10-K 表格年度報告對此進行了更詳細的描述。

This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, November 13, 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.

本次電話會議所包含的時間敏感資訊僅截至本次直播之日（2023 年 11 月 13 日）準確。Eyenovia 不承擔修改或更新任何前瞻性陳述以反映本次會議日期之後的事件或情況的義務除非適用的證券法有要求。

And with that said, I'd like to turn the call over to Michael Rowe, Chief Executive Officer.

話雖如此，我想將電話轉給執行長 Michael Rowe。

Michael?

麥可？

Thank you, Bren, and welcome, everyone, to our third quarter 2023 financial results conference call. Eyenovia had a highly productive third quarter, both in terms of tangible results as well as setting the stage for our future success. I am excited to share our progress and plans this afternoon as we prepare for our targeted launch of Mydcombi , the potential approval and launch of AP13007 and future partnerships in glaucoma and dry eye to leverage and monetize the Optejet technology beyond our own development programs.

謝謝布倫，歡迎大家參加我們的 2023 年第三季財務業績電話會議。 Eyenovia 第三季的業績非常高效，無論是在實際成果方面，還是為我們未來的成功奠定了基礎。我很高興今天下午分享我們的進展和計劃，因為我們準備有針對性地推出Mydcombi、AP13007 的潛在批准和推出以及青光眼和乾眼症方面的未來合作夥伴關係，以在我們自己的開發計劃之外利用Optejet 技術並從中獲利。

Let's start with our commercial preparations for the Mydcombi launch. For those of you who might not be familiar with Mydcombi. It's the first and only FDA approved fixed combination of two popular pupil dilation drugs and the first electro-mechanical spray platform using the Optejet. Earlier this month, we were thrilled to announce that our contract manufacturer coastline International was approved by the FDA for Mydcombi commercial manufacturing production has already begun that coast line, and we expect to receive finished product into our warehouse in January 2024.

讓我們從 Mydcombi 發布的商業準備開始。對於那些可能不熟悉 Mydcombi 的人。它是第一個也是唯一一個 FDA 批准的兩種流行的瞳孔擴張藥物的固定組合，也是第一個使用 Optejet 的機電噴霧平台。本月早些時候，我們很高興地宣布，我們的合約製造商Coastline International 已獲得FDA 批准，用於Mydcombi 的商業製造生產已經開始在Coast Line 上進行，我們預計將於2024 年1 月將成品送入我們的倉庫。

In addition to manufacturing Mydcombi, we are also continuing to prepare the market and raise awareness about the product and the Optejet technology last week, we sponsor the course during the international joint commission on Allied Health personnel in ophthalmology is 51st Annual continuing education program. That, of course, was offered to ophthalmic technicians and provide that hands-on experience with our Optejet dispensing technology and the use of Mydcombi. We also have a significant exhibition booth at the American Academy of Ophthalmology and collected many leads and product requests from doctors who believe the technology addresses a significant unmet need in their practice.

除了製造 Mydcombi 之外，我們還繼續準備市場並提高對該產品和 Optejet 技術的認識，上週，我們在眼科聯合健康人員國際聯合委員會第 51 屆年度繼續教育計劃期間贊助了該課程。當然，這是向眼科技術人員提供的，並提供我們的 Optejet 點膠技術和 Mydcombi 使用的實務經驗。我們還在美國眼科學會設有一個重要的展位，並收集了許多來自醫生的線索和產品請求，他們相信該技術解決了他們實踐中未滿足的重大需求。

Last month, we presented data at the American Academy of Optometry Annual Meeting, demonstrating the optejet ability to maintain sterility even when exposed to a high microbial load. This presentation was particularly timely given all the recent news about contaminated over-the-counter eyedrops being pulled off the shelves of major drug store chains and retailers due to the risk of serious eye infection and even blindness.

上個月，我們在美國驗光學會年會上展示了數據，證明 optejet 即使暴露在高微生物負荷下也能保持無菌狀態。鑑於最近有關受污染的非處方眼藥水因存在嚴重眼部感染甚至失明的風險而被各大連鎖藥店和零售商下架的消息，本次演講顯得尤為及時。

In conditions that far exceed the microbial load that the Optejet would be exposed to an actual daily use. The device demonstrated its ability to maintain product sterility. We are now in the process of validating the Optejet ability to deliver topical medication without preservatives for an extended period of time. Our activities at these professional meetings have been a great avenue to continue socializing Mydcombi to ophthalmologists, optometrists and technicians and positions us well for a broader commercial launch of Mydcombiearly next year. The current US market for pupil dilation is valued at approximately $250 million, and we feel we are poised to take a good portion of that market share over the coming years, especially when we move to our next generation device.

在遠超過 Optejet 實際日常使用的微生物負荷的條件下。該設備展示了其保持產品無菌的能力。我們現在正在驗證 Optejet 長期提供不含防腐劑的局部藥物的能力。我們在這些專業會議上的活動是繼續與眼科醫生、驗光師和技術人員交流 Mydcombi 的一個很好的途徑，並為明年初 Mydcombi 更廣泛的商業發布做好了準備。目前美國瞳孔擴張市場價值約為 2.5 億美元，我們認為我們準備在未來幾年佔據該市場份額的很大一部分，特別是當我們轉向下一代設備時。

More information, including ordering instructions and customer reaction to this unique product will appear shortly on Mydcombi.com in 2024. We not only anticipate Mydcombi be generating revenue for us, but we are looking forward to the potential FDA approval of APP13007 in early March 2024. We received recently announced an agreement with Formosa pharmaceuticals to acquire the exclusive US rights to distribute and sell APP13007 or clobetasol Pioneer ophthalmic solution, APP13007 is a potent oral potent steroid with a highly desirable safety and efficacy profile.

更多信息，包括訂購說明和客戶對這款獨特產品的反應，將於2024 年很快出現在Mydcombi.com 上。我們不僅預計Mydcombi 將為我們帶來收入，而且我們期待FDA 於2024 年3 月上旬批准APP13007我們最近宣布與台塑製藥達成協議，獲得在美國獨家經銷和銷售APP13007 或氯倍他索先鋒眼用溶液的權利，APP13007 是一種強效口服強效類固醇，具有非常理想的安全性和有效性。

It is currently under FDA review for post ocular surgery, inflammation and pain. Unlike almost all alternatives, this product is intended to be dosed twice daily without titration which is significantly more convenient than the four times a day dosing regimens with titration for existing treatments.

目前它正在接受 FDA 對眼科手術後、發炎和疼痛的審查。與幾乎所有替代品不同，該產品旨在每天兩次給藥，無需滴定，這比現有治療的每天四次滴定給藥方案要方便得多。

There are approximately 7 million ocular surgeries annually and almost all of these procedures utilize topical steroids during the recovery process. This is potentially a significant market for us, and we expect to leverage our planned 10 person sales force for both Mydcombi and AP13007 and add significant value to optometry and ophthalmology offices and surgical centers. In addition to providing near term revenue, APP13007 has the potential for additional indications in the Optejet, including dry eye, a multibillion-dollar dollar market opportunity.

每年約有 700 萬例眼科手術，幾乎所有這些手術在恢復過程中都會使用局部類固醇。這對我們來說是一個潛在的重要市場，我們希望利用我們計劃的 10 人銷售團隊來銷售 Mydcombi 和 AP13007，並為驗光和眼科辦公室以及手術中心增加顯著的價值。除了提供短期收入外，APP13007 還具有在 Optejet 中用於其他適應症的潛力，包括乾眼症，這是一個價值數十億美元的市場機會。

Following the potential approval for the post-surgical indication on March 4 of next year, we look forward to working with Formosa and the FDA to determine the most efficient path forward for this new product. We continue to explore additional partnering opportunities that we believe will benefit our company and our shareholders, specifically in glaucoma and dry eye. And we will provide you with updates on these developments when appropriate.

繼明年 3 月 4 日手術後適應症可能獲得批准後，我們期待與 Formosa 和 FDA 合作，確定該新產品最有效的前進路徑。我們將繼續探索更多合作機會，我們相信這些機會將使我們的公司和股東受益，特別是在青光眼和乾眼症領域。我們將在適當的時候向您提供這些進展的最新資訊。

I'll provide a brief regulatory update. Now we have always believed that the Optejet due to its ergonomic design that eliminates the need for healthy and handling small eyedropper bottles would be easier to use in many populations than currently available topical options and in our own market research that we shared with you in the past, consumers and patients reported using eyedrops was among the most difficult ways to use medication that they experience.

我將提供簡短的監管更新。現在，我們始終相信，Optejet 由於其符合人體工學的設計，消除了對健康和處理小滴管瓶的需要，比目前可用的局部選擇以及我們自己的市場研究（我們在過去，消費者和患者報告說，使用眼藥水是他們經歷過的最困難的藥物使用方法之一。

With that in mind, we recently held a successful meeting with the FDA to ask how we might demonstrate this benefit. We confirm with the agency that there is a path forward to include language in our labeling that covers patients who have difficulty or cannot reliably use eye drops as long as we provide evidence of a clinical benefit either in efficacy or safety of the eye of the Optejet product compared to the eyedrop product.

考慮到這一點，我們最近與 FDA 舉行了一次成功的會議，詢問我們如何證明這項好處。我們與該機構確認，只要我們提供 Optejet 眼睛的功效或安全性臨床益處的證據，就可以在我們的標籤中包含涵蓋有困難或無法可靠使用滴眼劑的患者的語言產品與滴眼劑產品相比。

We believe such labeling would not only help prescribers select our future products and classes such as glaucoma or dry eye, but this difference could lead to better formulary coverage trough digit products as they would be the only products to provide an option for patients who have a challenging time with eyedrops.

我們相信，這樣的標籤不僅可以幫助處方者選擇我們未來的產品和類別，例如青光眼或乾眼症，而且這種差異可能會導致數位產品更好的處方覆蓋率，因為它們將是唯一為患有青光眼或乾眼症的患者提供選擇的產品。滴眼藥水的挑戰時間。

Now turning to aperture are our proprietary topical on-demand pilocarpine based therapeutic candidate that we are developing for the temporary improvement in near vision associated with presbyopia. Aperture is being designed with our more advanced Gen two Optejet device, which has been optimized for in-home use. These will be manufactured in our Redwood City facility, which is currently prioritizing manufacturing the Gen two device to supply our partners, Bausch & Lomb and Arctic Vision with product for use in their pediatric myopia studies at the beginning of 2024.

現在轉向孔徑是我們專有的局部按需毛果芸香鹼治療候選藥物，我們正在開發該候選藥物，以暫時改善與老花眼相關的近距離視力。 Aperture 採用我們更先進的第二代 Optejet 設備進行設計，該設備已針對家庭使用進行了最佳化。這些設備將在我們的雷德伍德城工廠生產，該工廠目前正在優先生產第二代設備，以便為我們的合作夥伴 Bausch & Lomb 和 Arctic Vision 提供產品，以便在 2024 年初用於兒童近視研究。

As a reminder, we are paid by our partners for reducing the supply, and that income helps cover a portion of our overhead for that facility. Because of this, we have moved the manufacture of registration batches for aperture into the first quarter of 2024. We do not believe this change will materially impact the eventual timing of the official launch as the market for topical presbyopia treatments continues to evolve and mature as evidenced by the performance to date of the only presbyopia eyedrop currently on the market.

提醒一下，我們的合作夥伴因減少供應而向我們支付費用，這些收入有助於支付我們該設施的部分管理費用。因此，我們已將光圈註冊批次的生產推遲到 2024 年第一季。隨著局部老花眼治療市場的不斷發展和成熟，我們認為這一變化不會對正式推出的最終時間產生重大影響。目前市場上唯一一款老花眼藥水的迄今為止的性能就證明了這一點。

Finally, for a corporate update, we are pleased to announce the appointment of Mr. Michael Geltzeiler, Tyler, to our Board of Directors and as an Independent Director and Chair of our Audit Committee. Mike comes to us with more than 35 years of senior financial leadership experience, including as former Chief Financial Officer of ADT Corporation, New York Stock Exchange, Euronext Reader's Digest Association and AC Nielsen. Mike previously served on the boards of Cypress Creek renewables and the Euronext Supervisory Board and is currently a Board member for Madison Square Boys and Girls Club and the University of Delaware. We are excited to have Mike on board and look forward to his guidance and insights. At this point, I'd like to turn the call over to our Chief Operating Officer Bren Kern for our manufacturing update. Bren?

最後，關於公司最新情況，我們很高興地宣布任命 Michael Geltzeiler, Tyler 先生為董事會成員，並擔任獨立董事和審計委員會主席。 Mike 擁有超過 35 年的高階財務領導經驗，包括擔任 ADT Corporation、紐約證券交易所、泛歐交易所讀者文摘協會和 AC Nielsen 的前財務長。麥克先前曾在 Cypress Creek 再生能源公司和泛歐交易所監事會的董事會任職，目前是麥迪遜廣場男孩女孩俱樂部和特拉華大學的董事會成員。我們很高興麥克加入，並期待他的指導和見解。此時，我想將電話轉給我們的營運長布倫·克恩 (Bren Kern)，以了解我們的製造最新情況。布倫？

Thank you, Michael. We have made significant progress in the third quarter as we continue to build up our manufacturing capabilities to support Mydcombii or Oxy jet platform in the Gen2 configuration, the registration batches for Azure. As Michael mentioned, we're delighted that the FDA approved the use of additional manufacturing site coastline International to support the Mydcombi.

謝謝你，麥可。我們在第三季取得了重大進展，我們繼續增強製造能力，以支援 Gen2 配置中的 Mydcombii 或 Oxy jet 平台，以及 Azure 的註冊批次。正如 Michael 所提到的，我們很高興 FDA 批准使用 Coastline International 的額外生產基地來支持 Mydcombi。

First one is always already commenced manufacturing of commercial products in support of a broader commercial launch of Mydcombi in the first quarter of 2024. As our Redwood City facility is currently under review with the FDA as an additional commercial manufacturing site from Mydcombi with a PDUFA date in February of 2024. Our Redwood City facility is also working towards qualifying our Gen two fill-and-finish line for both the clinical trial supplier of MicroPine and registration batches for aperture.

第一個始終是已經開始生產商業產品，以支持Mydcombi 在2024 年第一季更廣泛的商業推出。我們的紅木城工廠目前正在接受FDA 的審查，作為Mydcombi 的另一個商業生產基地，並有PDUFA日期2024 年 2 月。我們的紅木城工廠也致力於對 MicroPine 臨床試驗供應商和孔徑註冊批次的第二代填充和加工生產線進行資格認證。

As Michael mentioned, we're targeting delivery of batches for our partners and the initiation of aperture registration batches in the quarter of 2024. Additionally, our Reno facility continues to make significant progress in establishing base injector manufacturing. Recall in our last earnings call, we indicated that we installed the manufacturing equipment. Since then the manufacturing team has been optimizing the operation of equipment, including generating qualification protocols, and we are targeting the commencement of protocol execution before the end of the year, we continued to make significant progress in increasing our manufacturing capacity. I remain confident that we'll be well positioned to meet the anticipated demand for Mydcombi as well as for the other Optejet based products in clinical development.

正如 Michael 所提到的，我們的目標是在 2024 年季度為合作夥伴交付批次，並啟動孔徑註冊批次。此外，我們的里諾工廠在建立基礎噴油器製造方面繼續取得重大進展。回想一下，在我們上次的財報電話會議中，我們表示我們安裝了製造設備。從那時起，製造團隊一直在優化設備的運行，包括生成資格協議，我們的目標是在年底前開始執行協議，我們在提高製造能力方面繼續取得重大進展。我仍然相信，我們將能夠很好地滿足對 Mydcombi 以及臨床開發中其他基於 Optejet 的產品的預期需求。

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

我現在想將電話轉給我們的財務長約翰甘道夫 (John Gandolfo)，以提供最新的財務資訊。

Jon?

喬恩？

Thank you, Bran. For the third quarter of 2023, net loss was approximately $7.3 million, or $0.18 per share compared to a net loss of approximately $7.3 million or $0.21 per share for the third quarter of 2022. The third quarter of 2023 includes approximately $400,000 of non-recurring expenses associated with the rework or replacement of certain clinical trial Gen one devices, which were found to be defective after shipment to a licensee, the rework of replacement is not expected to have any impact on the enrollment or timing about CHAPERONE study.

謝謝你，布蘭。 2023 年第三季的淨虧損約為730 萬美元，即每股0.18 美元，而2022 年第三季的淨虧損約為730 萬美元，即每股0.21 美元。2023 年第三季包括約40 萬美元的非經常性虧損與某些臨床試驗第一代設備的返工或更換相關的費用，這些設備在運送給被許可人後被發現有缺陷，預計更換的返工不會對CHAPERONE 研究的註冊或時間產生任何影響。

Research and development expenses totaled approximately $3.6 million for the third quarter of 2023 as compared to $3.9 million for the third quarter of 2022. For the third quarter of 2023, G&A expenses were approximately $2.9 million compared to $3.4 million for the third quarter of 2022. Total operating expenses for the third quarter of 2023 were approximately $6.5 million compared to $7.2 million for the third quarter of 2022.

2023 年第三季的研發費用總計約為360 萬美元，而2022 年第三季為390 萬美元。2023 年第三季的一般管理費用約為290 萬美元，而2022 年第三季為340 萬美元。2023 年第三季的總營運費用約為 650 萬美元，而 2022 年第三季的總營運費用為 720 萬美元。

As of September 30, 2023, the company's cash and cash equivalents were approximately $20.7 million compared to $22.9 million as of December 31, 2022.

截至2023年9月30日，該公司的現金和現金等價物約為2,070萬美元，而截至2022年12月31日為2,290萬美元。

For a brief update on our licensing revenues. In addition to the cash balance noted above. We have receivables from our license partners of approximately $400,000 as of September 30, 2023. And in addition, we expect a product development milestone payment of approximately $1.8 million from Arctic Vision that we anticipate in the first quarter of 2024.

有關我們的授權收入的簡要更新。除上述現金餘額外。截至 2023 年 9 月 30 日，我們從許可合作夥伴處應收的款項約為 40 萬美元。此外，我們預計 Arctic Vision 將在 2024 年第一季支付約 180 萬美元的產品開發里程碑付款。

I'll now provide an update on our existing licensing program with Bausch Health for MicroPine in the US and Canada and Arctic Vision for all three of our products in China and South Korea. Bausch & Lomb is continuing to enroll in the ongoing Phase three CHAPERONE trial of MicroPine, a proprietary atropine formulation for the reduction of pediatric myopia progression that's been shown in clinical studies just to slow myopia progression by 60% or more.

現在，我將介紹我們與 Bausch Health 在美國和加拿大的 MicroPine 的現有許可計劃以及在中國和韓國的所有三種產品的 Arctic Vision 的現有許可計劃的最新情況。 Bausch & Lomb 正在繼續參與正在進行的 MicroPine 三期 CHAPERONE 試驗，MicroPine 是一種專有的阿托品製劑，用於減少兒童近視進展，臨床研究表明，它可以將近視進展減緩 60% 或更多。

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. Our agreement with Arctic Vision covers Greater China and South Korea and covers MicroPatent MicroLine and Mydcombi and provides US sales or sales royalties in addition to development milestones. MicroPine in particular is a significant opportunity in China for pediatric myopia. If approved, MicroPatent could be a significant source of non-dilutive funding for our company over the long term.

目前尚無 FDA 批准的針對該適應症的藥物療法。如果不及時治療，可能會導致視網膜剝離、近視性視網膜病變和視力喪失。我們與 Arctic Vision 的協議涵蓋大中華區和韓國，涵蓋 MicroPatent MicroLine 和 Mydcombi，並除了開發里程碑之外還提供美國銷售或銷售特許權使用費。 MicroPine 對於中國兒童近視來說尤其是一個重大機會。如果獲得批准，從長遠來看，MicroPatent 可能成為我們公司非稀釋性資金的重要來源。

To date, our license agreements have generated approximately $16 million in license fees and with the potential to earn an additional $60 million in net license and development milestones and reimbursable expenses over the next four years. If our products are approved upon commercialization, Eyenovia is also eligible to earn significant sales royalties. We are continuing to assess potential pipeline expansion opportunities similar to our promotion agreement, and we will continue to leverage the Optejet technology to address unmet needs in additional large ophthalmic indications.

迄今為止，我們的授權協議已產生約 1,600 萬美元的授權費，並有可能在未來四年內額外賺取 6,000 萬美元的淨許可和開發里程碑以及可報銷費用。如果我們的產品獲得商業化批准，Eyenovia 也有資格獲得可觀的銷售特許權使用費。我們正在繼續評估與我們的促銷協議類似的潛在管道擴張機會，我們將繼續利用 Optejet 技術來解決其他大型眼科適應症中未滿足的需求。

And conclusion, we are very pleased with our performance in the third quarter of '23 and to summarize our key highlights today, we acquired exclusive US commercial rights to APP13007 as a potential treatment for post-surgical ocular pain and inflammation from promotion of pharmaceuticals. We achieved our first commercial sale of Mydcombi in August 2023 and continue to carry out our targeted launch. Gen two up to GM production continues to advance, and we're continuing to build out our manufacturing capabilities to support Mydcombi, be production with coastline manufacturing now in production and our Redwood City facility anticipated to come online early 2024.

最後，我們對 23 年第三季的業績感到非常滿意，總結一下今天的主要亮點，我們透過藥品推廣獲得了 APP13007 的美國獨家商業權，作為手術後眼部疼痛和發炎的潛在治療方法。我們於 2023 年 8 月實現了 Mydcombi 的首次商業銷售，並繼續進行我們的目標上市。第二代至通用汽車的生產繼續推進，我們正在繼續建立我們的製造能力來支持 Mydcombi，海岸線製造現已投入生產，我們的紅木城工廠預計將於 2024 年初上線。

And our licensing agreements with Arctic Vision and Bausch & Lomb are progressing well and remain a promising avenue for significant development and regulatory milestones as well as the potential for additional salesr royalties. Concludes our prepared remarks. We would now like to like to open the call to questions.

我們與 Arctic Vision 和 Bausch & Lomb 的授權協議進展順利，並且仍然是實現重大開發和監管里程碑以及額外銷售商特許權使用費潛力的有希望的途徑。結束我們準備好的演講。我們現在想開始提問。

Operator?

操作員？

Thank you, sir. Ladies and gentlemen, we will now be conducting a question and answer session. (Operator Instructions)

謝謝你，先生。女士們、先生們，我們現在將進行問答環節。 （操作員說明）

Tim Lugo, William Blair.

提姆·盧戈，威廉·布萊爾。

Hi. This is John on for Tim. Thanks so much for taking our question. So I was wondering if you could give any color on why it any gating factors you have remaining to getting 13007 to look at going into the clinic for dry eye disease?Or are you just waiting for that to do so before moving forward?And as a follow-up, just wondering if you could provide any early thoughts on the trial design for the indication.Thanks.

你好。這是約翰替提姆發言。非常感謝您提出我們的問題。所以我想知道您是否可以給出任何解釋，為什麼您在獲得 13007 去診所治療乾眼病之前還剩下任何門控因素？或者您只是在等待這樣做，然後再繼續前進？後續行動，只是想知道您是否可以提供有關該適應症的試驗設計的任何早期想法。謝謝。

We are waiting for the for because once that is done, then we can reference that file for all of the product pre that preclinical and safety information saves us a lot of time. So the idea would be with the product we could go directly into Phase 3. We've spoken with the FDA. It would be two relatively short term Phase 3 studies because the initial indication would be an acute dry eye. So this would be used as an adjunct for flareups, for example, which is common because the current dry eye products, no, don't and don't do a particularly good job at solving the issue. So we've had the discussions, we know what the design would be, and we're waiting at this point for the approval because to go forward, we would want to reference the approved drug.

我們正在等待，因為一旦完成，我們就可以參考該文件來獲取所有產品的臨床前和安全信息，從而節省我們大量時間。所以我們的想法是我們的產品可以直接進入第三階段。我們已經與 FDA 進行了交談。這將是兩項相對短期的三期研究，因為最初的適應症是急性乾眼症。因此，這將被用作治療突發的輔助手段，例如，這種情況很常見，因為目前的乾眼產品在解決這個問題方面沒有做得特別好。所以我們已經進行了討論，我們知道設計是什麼，我們現在正在等待批准，因為要繼續前進，我們希望參考已批准的藥物。

Very helpful. Thanks so much.

很有幫助。非常感謝。

Matt Kaplan, late and big

馬特·卡普蘭（Matt Kaplan），遲到的大人物

Hi, this is Raymond in for Matt. Thanks for taking our questions and congrats on all the progress. And just wanted to ask about perhaps the drivers and moving parts for Mydcombi revenue as the launch it is near and near term. And I was wondering, is it state licenses, sales force for rollout? Any additional color would be helpful. And I just have a follow-up question.

嗨，這是雷蒙德代替馬特。感謝您提出我們的問題並祝賀我們取得的所有進展。只是想問 Mydcombi 收入的驅動因素和移動部件，因為它即將推出。我想知道，是國家許可、銷售人員推出的嗎？任何額外的顏色都會有幫助。我還有一個後續問題。

Sure. And thanks for calling the state licenses are falling into place. So at this point, it's manufacturing, which is underway. So we need to get the product into the warehouse in January, the two sales force leaders have been hired. They're now going to hire the remainder of the sales force, and that's time for when the product actually is available. And so at this point, everything is moving the way we would expected. And I would anticipate for sales the end of January.

當然。感謝您致電，州許可證正在落實到位。所以此時，它的製造正在進行中。所以我們需要在一月把產品入庫，兩位銷售領導者已經被雇用了。他們現在要雇用剩餘的銷售人員，到了產品真正上市的時候了。所以此時此刻，一切都在按照我們預期的方式發展。我預計一月底會銷售。

You appreciate that from here. I mentioned in prepared remarks, the gen-2 device, the FDA mentioned and the clinical efficacy, is that Morse superiority or non-inferiority over eyedrops?

從這裡你就明白了。我在準備好的發言中提到了gen-2設備、FDA提到的以及臨床療效，莫爾斯電碼相對於眼藥水是優越性還是非劣效性？

Well, I'll give you an example, and I'll use safety as an example, we know that the Optejet delivers one-fourth or one-fifth the dose, for example, of conventional eye drops. So if use beta-blockers as an example, if you take a beta blocker as an eye drop. And this is in the literature, it actually slows your heart rate by one or two beats per minute as a systemic side effect because the majority of that beta blocker, you're going to end up drinking because you're overdosing the eye. If you use the Optejet, you will have significantly less available systemically. And it is likely that we would be able to show that you don't have that impact that safety impact because you're getting the lower dose. That's the kind of thing that could end up in the label to differentiate the product.

好吧，我給你舉個例子，我會以安全性為例，我們知道 Optejet 提供的劑量是傳統滴眼劑的四分之一或五分之一。因此，如果以β受體阻斷劑為例，如果您將β受體阻斷劑當作滴眼劑。這是文獻中提到的，它實際上會降低你的心率每分鐘一到兩次，這是一種全身性副作用，因為大多數β受體阻斷劑，你最終都會喝酒，因為你的眼睛用藥過量。如果您使用 Optejet，您的系統可用率將大大減少。我們很可能能夠證明您沒有受到安全性影響，因為您接受的劑量較低。這種東西最終可能會出現在標籤上以區分產品。

Appreciate the color, and I'll hop back in the queue.

欣賞這個顏色，我會重新加入隊列。

Thank you.

謝謝。

[Len Yaffe], Stock.com partners. .

[Len Yaffe]，Stock.com 合作夥伴。 。

Thank you. Very much. Hi, Mike. I wanted to ask you a question about APP13007. And I was wondering, I was very excited to hear you talk about the dry eye application because that's seemingly a very large market. Could you discuss to the extent you have data in the US the size of that market, how much of it is cider and Restasis versus over-the-counter drops. And you mentioned initially you'll be competing in the acute dry eye segment. How big of the total dry eye market is that and it seems like this would be a perfect drug to be put in the Gen two oxygen device. How much more do you think that could potentially expand the use of the drug? Is given that you'd have it available and Optejet. Thanks so much.

謝謝。非常。嗨，麥克。我想問你一個關於 APP13007 的問題。我想知道，我很高興聽到您談論乾眼應用，因為這似乎是一個非常大的市場。您能否就美國市場的規模、蘋果酒和 Restasis 與非處方藥的比例等數據進行討論。您最初提到您將參與急性乾眼症領域的競爭。整個乾眼市場有多大，這似乎是放入第二代氧氣設備中的完美藥物。您認為這可能會進一步擴大該藥物的使用範圍嗎？假定您擁有可用的 Optejet。非常感謝。

Thank you, Len. And I think I'm going to steal that AP13007 from now on. It's easier to say, we think it's a tremendous opportunity. And let me start with why on the Optejet and I'll go back to when we talk to the FDA about differentiating the Optejet from an eyedrop. One of the issues with steroids as a class is that historically when you use them for an extended period of time, they can cause something called an IOP spike, which is a transient interocular pressure, a increase which you don't want to see in patients who are sensitive like patients who have glaucoma.

謝謝你，萊恩。我想從現在開始我要偷那個 AP13007。說起來更容易，我們認為這是一個巨大的機會。讓我從為什麼選擇 Optejet 開始，然後我會回顧一下我們與 FDA 討論 Optejet 與滴眼劑的區別時的情況。類固醇作為一類的問題之一是，從歷史上看，當您長時間使用它們時，它們可能會導致稱為眼壓峰值的現象，這是一種短暫的眼間壓，這是您不希望看到的增加。敏感的患者，例如青光眼患者。

So the FDA is very concerned about that now covers all the formulation we have in clinical trials. We only saw that in one patient out of 180, which is basically the same as you would see in the general population without drug. So we think this is a particularly good drug for dry eye because you don't see the IOP spike to begin with. But the benefit of using the Optejet is because you're delivering one quarter or the fifth dose is that if these IOP spikes are related to dosing, you should see it even less which would be the additional benefit while still giving the dry eye pain and inflammation relief.

所以 FDA 非常關心現在涵蓋了我們臨床試驗中的所有配方。我們只在 180 名患者中發現了一名患者，這與在沒有藥物的情況下在普通人群中看到的情況基本相同。因此，我們認為這是一種治療乾眼症特別好的藥物，因為您一開始就看不到眼壓高峰。但使用Optejet 的好處是，因為您要注射四分之一或第五劑，如果這些IOP 峰值與劑量相關，您應該​​會看到更少，這將是額外的好處，同時仍會導致乾眼疼痛和發炎緩解。

So that's why we want to put it into the Optejet to get that additional benefit as for the market opportunity for people who are on cyclosporin or Restasis or on Lifitegrast, many of you know that that's not enough and you're still using artificial tears and you're still having problems. So this would be a product if approved that you would use for those at those times where it's getting just a little bit too much and you need something for 14 weeks to calm down the ocular surface in terms of market size, it doesn't really compete with the other drugs. It's used in addition to them from time to time, there are millions and millions of patients out there. So this could easily be a multi-billion dollar opportunity for the right drug. And we think we have something that is really special with AP13007

因此，這就是為什麼我們希望將其放入Optejet 中，以獲得額外的好處，為使用環孢素或Restasis 或Lifitegrast 的人帶來市場機會，你們中的許多人都知道這還不夠，而且你們仍在使用人工淚液，你仍然遇到問題。因此，如果獲得批准，這將是一個產品，您可以在那些時候使用它，因為它變得有點太多，並且您需要14 週的東西來使眼表平靜下來，就市場規模而言，它實際上並不重要。與其他藥物競爭。除了它們之外，還有數以百萬計的患者不時使用它。因此，對於合適的藥物來說，這很可能是一個價值數十億美元的機會。我們認為 AP13007 確實很特別

Thank you.Okay.And secondly, could you comment on when the MicroPine studies would be complete either by Bausch or optics, so the drug could be ready profiling given that that market, especially and post pandemic and younger folks spending so much time on their cellphones and either texting or playing video games for the incidence of progressive myopia is increasing. It seems like it's a very large.

謝謝。好的。其次，您能否評論MicroPine 研究何時由Bausch 或光學完成，以便該藥物可以準備好進行分析，因為該市場，特別是在大流行後，年輕人花費大量時間在他們的藥物上手機、發送簡訊或玩電子遊戲導致進行性近視的發生率正在增加。看起來好像是一個非常大的東西。

Yes, I can't speak for either of those companies as they're operating their own studies. I can tell you that in previous conversations, and I know that they would like to finish their enrollment in 2024. So assuming that's the case, it's three years to an efficacy endpoint after that, which would take you to the end of 2027. So I think any kind of filing would probably be in 2028.

是的，我不能代表這兩家公司發言，因為他們正在進行自己的研究。我可以在之前的談話中告訴你，我知道他們希望在 2024 年完成註冊。因此，假設情況確實如此，那麼三年後才能達到療效終點，即到 2027 年底。我認為任何類型的申請都可能會在2028 年進行。

Great. And when you refer to it is bond I'll take a little late CRP with my name after it, so should set us up for, I think so much share, though.Thank you.

偉大的。當你提到它是債券時，我會晚一點拿到CRP，後面寫上我的名字，所以應該為我們做好準備，但我認為有很多份額。謝謝。

Okay.

好的。

Thank you. Ladies and gentlemen, we have reached the end of the question and answer session. I will now hand over to Michael for his closing remarks.

謝謝。女士們、先生們，問答環節已經結束。現在請麥可致閉幕詞。

Thank you, operator, and thank all of you for joining us today. And that concludes today's call. We are very pleased with the year we have had so far and we are excited to close out 2023 with strong momentum. So thank you again for joining us. We look forward to our full fiscal year update in March or April of next year.

謝謝運營商，也謝謝大家今天加入我們。今天的電話會議到此結束。我們對迄今為止所經歷的一年感到非常滿意，並很高興以強勁的勢頭結束 2023 年。再次感謝您加入我們。我們期待明年三月或四月的完整財政年度更新。

Thank you. Ladies and gentlemen, that concludes today's event. Thank you for joining us, and you may now disconnect your lines.

謝謝。女士們、先生們，今天的活動到此結束。感謝您加入我們，您現在可以斷開線路了。