Eyenovia Inc (EYEN) 2023 Q1 法說會逐字稿

完整原文

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  • Operator

    Operator

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

    問候。歡迎來到 Eyenovia 2023 年第一季度財報電話會議。 (操作員說明)請注意,正在錄製此會議。我現在將會議轉交給首席財務官 John Gandolfo。謝謝。你可以開始了。

  • John P. Gandolfo - CFO & Secretary

    John P. Gandolfo - CFO & Secretary

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

    謝謝。下午好,歡迎收看 Eyenovia 2023 年第一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 的首席執行官 Michael Rowe;首席運營官 Bren Kern。

  • This afternoon, we issued a press release announcing financial results for the 3 months ended March 31, 2023. We encourage everyone to read today's press release as well as Eyenovia's quarterly report on Form 10-Q for the quarter ended March 31, 2023, which will be filed with the SEC tomorrow, May 12, 2023, as well as our most recently filed 10-K.

    今天下午,我們發布了一份新聞稿,宣布了截至 2023 年 3 月 31 日止的 3 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 2023 年 3 月 31 日止季度的 10-Q 表季度報告,其中將於明天(2023 年 5 月 12 日)以及我們最近提交的 10-K 向美國證券交易委員會提交。

  • Company's press release and annual report are also available on our website at www.eyenovia.com.

    公司的新聞稿和年度報告也可在我們的網站 www.eyenovia.com 上獲取。

  • In addition, this conference call is being webcast to the company's website and will be archived there for future reference.

    此外,該電話會議正在公司網站上進行網絡直播,並將在那裡存檔以備將來參考。

  • Please note that on today's call, we will be discussing investigational product candidates, some of which have yet to receive FDA approval.

    請注意,在今天的電話會議上,我們將討論研究候選產品,其中一些產品尚未獲得 FDA 批准。

  • Please also note that certain information discussed on the call today is covered under the safe harbor provisions of the Private Securities Litigation Reform Act. We caution listeners that during the call, Eyenovia's management will be making forward-looking statements. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are subject to a number of risks, which are described in more detail in our annual report on Form 10-K.

    另請注意,今天電話會議上討論的某些信息包含在《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。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。

  • This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, May 11, 2023. Eyenovia undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as may be required by applicable securities law.

    本次電話會議包含僅截至本次直播之日(2023 年 5 月 11 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?

  • Michael M. Rowe - CEO & Director

    Michael M. Rowe - CEO & Director

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

    謝謝約翰,歡迎大家參加我們的 2023 年第一季度財務業績電話會議。我將從我們最近 FDA 批准 MydCombi 的更新開始,該批准如何符合我們的整體戰略,然後為 MicroLine 提供既定的更新。我們的首席運營官 Bren Kern 將跟進我們的製造和商業準備進度的最新情況。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。

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

    在今年第一季度和最近,我們在所有既定目標上取得了重大進展,FDA 批准了我們的第一個產品 MydCombi。我們還收到了來自 FDA 的非常鼓舞人心的反饋,並相信我們的 MicroLine 老花眼項目有一條清晰的前進道路。

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

    在製造方面,我們正在加強我們的活動,我們將在下個季度讓我們的 Reno 設施上線,並在今年晚些時候生產 Optejet Gen2 臨床批次。最後,我們與 Formosa 以及我們期望的其他合作夥伴關係將為利用我們的 Optejet 技術的其他眼科 [療法] 鋪平道路。

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

    我將通過強調我們最近的成就來開始通話。就在幾天前,我們獲得了 FDA 對 MydCombi 的批准,MydCombi 是我們的托吡卡胺和去氧腎上腺素微劑量製劑的專有組合,用於在診斷程序和需要短期瞳孔擴張的情況下誘導瞳孔散大。這是美國首個獲批的托吡卡胺和 [去氧腎上腺素] 固定劑量組合,重要的是,它也是首個獲批使用我們的 Optejet 分配設備的產品。我怎麼強調這個批准對我們公司的重要性都不為過。 Optejet 是我們開發管道和合作項目的基礎。此次 FDA 批准為 Optejet 在其他高價值適應症中提供的額外丘腦療法的未來發展開創了先例。

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

    FDA 對 MydCombi 的批准為我們的技術提供了重要的外部驗證,這只是可以使用 Optejet 的眾多眼科適應症中的第一個。該批准也標誌著 Eyenovia 從一家開發公司正式轉型為一家商業機構。管理團隊非常感謝我們所有的 Eyenovia 同事,感謝他們通過這一重要里程碑為推進該計劃所做的貢獻。

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

    自周一以來,我們收到了大量來自眼科和驗光辦公室的來電和電子郵件,詢問他們何時可以獲得 MydCombi。需要該產品的原因包括水平輸送、較低的藥物體積暴露、醫生和技術人員都易於使用。一位醫生說她計劃改變她的辦公室流程,這樣她就可以在候診室為病人擴張,而不必讓他們把頭向後仰。當然,我們認為這是非常令人鼓舞的。

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

    我們計劃在今年夏天晚些時候將 MydCombi 引入幾個主要的眼科和驗光辦公室,作為我們有針對性的啟動過程的一部分。儘管我們很想明天就去那裡,但我們需要一些時間來帶來我們的內部製造能力,這些能力在網上更具成本效益。到 2024 年初,我們預計我們在雷德伍德城和里諾的設施將達到滿負荷生產。

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

    目前,客戶和你們所有人都可以通過訪問網站 mydcombi.com 了解有關 MydCombi 的更多信息,並儘快跟踪我們的發布進度,並最終聽到醫生和患者對該產品的評價。

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

    我現在將轉向 MicroLine,這是我們正在開發的專有局部按需試點泊車治療候選藥物,用於暫時改善與老花眼相關的近視力。您應該還記得,老花眼是與年齡相關的晶狀體硬化,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,否則他們永遠不會戴眼鏡並且擁有現金支付產品的資源。我們專有的市場研究表明,僅在美國,這可能是一個每年數十億美元的市場。

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

    我們最近收到了來自 FDA 的反饋,為該計劃指明了一條通往新藥申請或 NDA 的明確前進道路。 MicroLine 設計用於我們更小、更先進的 Gen2 Optejet 設備,該設備已針對家庭使用進行了優化。用於製造和填充 Gen2 墨盒的機器正在我們的紅木城工廠中安裝和驗證。我們預計在滿足合作夥伴的合同臨床需求後,將在 2024 年上半年運行 NDA 註冊批次。

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

    在提交 NDA 之前,FDA 要求最終包裝產品有 12 個月的實時穩定性數據。因此,我們打算在運行這些批次後大約 10 個月提交文件。

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

    然而,在這 12 個月中,我們不會坐以待斃。我們將開展其他重要的 NDA 前活動,包括支持人為因素和臨床工作,以證明 Gen2 設備在目標人群中的可用性,以及衡量患者對 Optejet 系統的偏好。這項工作將用於支持 MicroLine NDA 和即將到來的產品商業化。

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

    作為 Optejet 設備中的眼科噴霧劑,我們相信 MicroLine 具有許多獨特的功能,可能使其有別於老花眼藥水選項。我們技術的特點可能使產品的使用更容易,同時降低藥物和防腐劑的暴露並可能提高耐受性。在我們進行的市場調查中,設備本身的吸引力已被指出是一個非常需要的功能。而 MicroLine 也可能更適合許多驗光師的商業模式。許多醫生在他們的實踐中都有零售部分,他們為老花眼患者銷售眼鏡、隱形眼鏡和其他產品。 MicroLine 可以很好地融入他們的範例,因為他們可能能夠將支持項目包括在這些產品中,例如獨特的設備皮膚、入門工具包等。

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

    我們最近對 100 名驗光師進行了市場調查,將 MicroLine 與 2025 年可能上市的 5 種現有或潛在老花眼滴眼液進行了比較。我們發現,MicroLine 在與驗光師會面方面被接受調查的醫生評為第一名' 和他們的病人的整體需求。這些醫生估計,微線可以佔領多達1/3的老花眼藥市場,與其他5家滴眼液競爭剩餘的2/3市場。

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

    如果 MicroLine 獲得批准,我們相信 Optejet 憑藉其設計、易用性和較低的藥物體積,將產品區分開來,最終,其他醫生將從許多不同的滴眼液或 MicroLine 中選擇患者而且只能噴。

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

    轉向我們的合作活動。我們很高興在 2 月宣布與台灣台塑製藥達成開發合作協議。該協議旨在將我們的 Optejet 與 Formosa 獨特的 APMT 納米顆粒製劑平台結合起來,以開發採用 Optejet 設備的新型局部眼科治療藥物。 Formosa 專有的創新 APMT 平台提高了活性藥物成分的生物利用度和溶解度,允許更均質的配方,這些配方可能會擴大我們現有和未來藥物的領域,這些藥物可能會受益於使用 Optejet 的交付。

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

    我們相信,與 Formosa 達成的這項協議將為我們管道的潛在擴張開闢新的大型市場跡象,並可作為未來合作夥伴關係的典範。我們將繼續推進與潛在合作夥伴的討論,這些合作夥伴可能會在他們自己的開發計劃(例如青光眼和乾眼症)中受益於 Optejet。像這樣的共同開發夥伴關係,解決未滿足需求的大型眼科適應症是我們中長期增長戰略的關鍵部分。

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

    我們正在繼續構建大量數據,以證明 Optejet 優於傳統滴眼液的優勢。 1 月,我們宣布了與塔夫茨醫學中心眼科臨時主席 Pedram Hamrah 博士合作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的基因和蛋白質表達,拉坦前列素是一種用 BAK 保存的青光眼藥物,通過 Optejet 給藥與通過標準滴眼液給藥。在這些早期發現中,Optejet 技術似乎優於標準滴眼液並減少了炎症過程。

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

    Optejet 被發現可以達到治療劑量的拉坦前列素,而使用傳統滴劑可以達到的過量藥物和有害防腐劑暴露顯著減少。這些結果也在上個月的視覺和眼科研究協會年會上公佈。

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

    在這一點上,我想把電話轉給我們的首席運營官 Bren Kern,了解我們的製造更新。布倫?

  • Bren Kern - COO & Corporate VP

    Bren Kern - COO & Corporate VP

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

    謝謝你,邁克爾。在獲得 FDA 對 MydCombi 的批准後,我們一直在與我們的供應商合作,以完成我們即將推出的 MydCombi 商業發布的準備工作。材料訂單計劃正在最終確定中,我們正在優化流程以符合 FDA 在審查期間提出的要求。我們的紅木城工廠與我們的合同製造商一起,繼續支持我們的臨床合作夥伴 Bausch + Lomb 和 Arctic Vision,並定期交付臨床用品。此外,紅木城工廠在驗證我們的灌裝和成品線以支持 Gen2 分配器平台方面取得了重大進展。這一進展為啟動高容量、自動灌裝和完成線的設計注入了信心,這將支持我們對 Gen2 設備的預期需求流。

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

    這個最先進的系統應該在 2024 年下半年安裝,此後將進行額外的資格認證。此外,我們的里諾工廠在建立基地和噴射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上,我們注意到設施建設正在進行中。這些活動現已完成,我們里諾辦公室的工作人員已經入住。

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

    生產設備即將抵達,隨後將進行安裝和鑑定活動。上個季度,我們宣布任命 Enrico Brambilla 為 Eyenovia 的產品研究副總裁。 Enrico 於 4 月加入我們,我們已經在利用他的專業知識並通過確定新員工、工程工具和提高效率來迅速提高我們的工程能力,這些將在我們的分配器和一系列藥品中得到利用。對於我們在過去幾個月中取得的重大進展,我由衷地感到興奮。我們的運營能力每天都在提高。 MydCombi 的批准成功證明了我們的分配平台是局部眼科藥物應用的可行技術解決方案。

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

    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?

  • John P. Gandolfo - CFO & Secretary

    John P. Gandolfo - CFO & Secretary

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

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

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

    2023 年第一季度的研發費用總計約為 250 萬美元。相比之下,2022 年同期約為 370 萬美元,減少了約 32%。

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

    2023 年第一季度,一般和行政費用約為 290 萬美元,與 2022 年第一季度的約 350 萬美元相比下降了約 15.5%。

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

    2023 年第一季度的總運營費用約為 550 萬美元,而 2022 年同期的總運營費用為 720 萬美元。這減少了約 24%。

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

    截至 2023 年 3 月 31 日,公司的現金餘額約為 1850 萬美元,而截至 2022 年 12 月 31 日為 2290 萬美元。此外,公司有能力在 7 月 31 日之前從 Avenue 資本信貸額度中額外提取 500 萬美元, 2023 年,基於 MydCombi 最近的批准。

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

    許可計劃是公司當前和未來潛在收入的重要來源。我們戰略的一個主要部分是完成額外的協議作為非稀釋性資本的來源。除了我上面提到的現金餘額外,截至 2023 年 3 月 31 日,我們還有一筆來自許可合作夥伴的應收賬款約為 975,000 美元,我預計 Arctic Vision 將在 2023 年下半年償還約 200 萬美元的產品開發費用2023.

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

    在我們開始提問之前,我將簡要介紹一下我們與 Bausch Health 在美國和加拿大的 MicroPine 以及 Arctic Vision 在中國和韓國的所有 3 種產品的現有許可計劃的最新情況。 MicroPine 是一種專有的阿托品配方,可減緩小兒近視的發展。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 批准的針對該適應症的藥物療法。

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

    如果不及時治療,可能會導致視網膜脫離、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。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 臨床試驗相關的費用已轉移給我們的合作夥伴,並且入組正在按計劃進行。我們與 Arctic Vision 的協議涵蓋大中華區和韓國,涵蓋 MicroPine、MicroLine 和 MydCombi。因此,Arctic Vision 現在在這些地區授權我們所有 3 個現有項目。

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

    特別是用於兒童近視的 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。我們與 Arctic Vision 的協議除了開發里程碑外,還為我們提供銷售版稅。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。

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

    迄今為止,我們的許可協議已產生約 1600 萬美元的許可費用,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。

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

    商業化後,如果我們的產品獲得批准,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 技術來解決其他大型眼科適應症中未滿足的需求。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, we received FDA approval of MydCombi, a fixed-dose combination of tropicamide and phenylephrine mydriasis, and the first FDA-approved product to utilize the Optejet. We received feedback from FDA on a Phase III MicroLine presbyopia candidate that provides a clear and efficient path forward for the program that can potentially address a multibillion-dollar annual market in the U.S. alone. We announced a co-development agreement with Formosa Pharmaceuticals. Our manufacturing facility in Redwood City, California is operational. And our second facility in Reno, Nevada, is on track to be operational in the third quarter.

    總之,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,我們獲得了 FDA 對 MydCombi 的批准,這是一種托吡卡胺和去氧腎上腺素散瞳的固定劑量組合,也是 FDA 批准的第一個使用 Optejet 的產品。我們從 FDA 收到了關於 III 期 MicroLine 老花眼候選藥物的反饋,該候選藥物為該項目提供了一條清晰有效的前進道路,該項目可能僅在美國就擁有數十億美元的年度市場。我們宣布了與 Formosa Pharmaceuticals 的共同開發協議。我們位於加利福尼亞州雷德伍德城的製造工廠已投入運營。我們在內華達州里諾的第二家工廠有望在第三季度投入運營。

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

    正如我們與 [Tops] 合作研究的結果所示,我們繼續擴大對 Optejet 的研究範圍,該研究強調了 Optejet 繞過與慢性眼科治療相關的常見不良反應的巨大潛力。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 2 年內實現潛在銷售特許權使用費提供機會。

  • 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

    Operator

  • (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。

  • Matthew Lee Kaplan - MD & Head of Healthcare Equity Research

    Matthew Lee Kaplan - MD & Head of Healthcare Equity Research

  • And congratulations on the approval of MydCombi. That was terrific news earlier this week.

    並祝賀 MydCombi 獲得批准。這是本週早些時候的好消息。

  • Michael M. Rowe - CEO & Director

    Michael M. Rowe - CEO & Director

  • Thanks, Matt.

    謝謝,馬特。

  • Matthew Lee Kaplan - MD & Head of Healthcare Equity Research

    Matthew Lee Kaplan - MD & Head of Healthcare Equity Research

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

    你能談談商業推廣嗎?你在準備好的發言中提到了其中的一些內容,但在我們進入今年晚些時候和明年時,我們應該如何考慮這一點?

  • Michael M. Rowe - CEO & Director

    Michael M. Rowe - CEO & Director

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

    是的,我會接受的。非常感謝你,馬特。我們將在今年夏天晚些時候推出。這將是分階段或有針對性的推出。原因是我現在就在里諾,在我們的里諾工廠,看著他們安裝激光器、烤箱和其他設備。對我們來說,自己生產大部分產品比使用合同製造更具成本效益。因此,我們將有針對性地在今年夏天晚些時候在一些主要辦公室推出該產品。但 MydCombi 的真正推動將在今年年底到明年,屆時我們的生產設施將在這裡得到全面驗證和運行。

  • So I would look at it as for this year, it's more to get it into the hands of some very key doctors and get the momentum building for it, collecting names on mydcombi.com, for example, and then we'll be able to turn everything next year.

    所以我會在今年看它,更重要的是把它交到一些非常重要的醫生手中,並為它建立勢頭,例如在 mydcombi.com 上收集名字,然後我們就能夠明年改變一切。

  • Matthew Lee Kaplan - MD & Head of Healthcare Equity Research

    Matthew Lee Kaplan - MD & Head of Healthcare Equity Research

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

    偉大的。你能談談定價以及定價的方式嗎?

  • Michael M. Rowe - CEO & Director

    Michael M. Rowe - CEO & Director

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

    是的。所以 5 個墨盒的價格是 599 美元。比方說,大約 120 美元一盒。每個墨盒將支持大約 75 名患者。因此,以每位患者為基礎,大約為 1.60 美元。現在,如果你看看醫生在 3 種眼藥水上的花費,他們的花費約為 1.20 美元。所以增加了 0.40 美元,但客戶告訴我們,當他們將其與患者節省的時間、便利性和整體更好的情況進行比較時,他們認為這不會成為他們採用它的任何障礙。

  • Matthew Lee Kaplan - MD & Head of Healthcare Equity Research

    Matthew Lee Kaplan - MD & Head of Healthcare Equity Research

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

    好的。偉大的。然後稍微換檔。你提到你從 FDA 那裡收到了一些關於你的 MicroLine 計劃的積極反饋。您能否向我們提供有關該反饋的更多詳細信息以及 NDA 註冊的前進道路?

  • Michael M. Rowe - CEO & Director

    Michael M. Rowe - CEO & Director

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

    正確的。因此,我們的 VISION-1 和 VISION-2 研究是在 MydCombi 獲得批准的同一個分配器中進行的。它是一個很好的分配器。它非常適合診所。然而,我們希望 MicroLine 對消費者更加友好,因此,我們希望將其過渡到我們的 Gen2,它更纖細、更便攜,適合(聽不清)該產品。所以我們向 FDA 提出的問題基本上是,鑑於它們在如何提供藥物方面具有非常相似的特徵,您如何從 Gen1 過渡到 Gen2? FDA 向我們提供了該信息。它涉及驗證設備的方式與我們對 MydCombi 所做的方式相同。獲得 MydCombi 批准的美妙之處在於我們確切地知道如何做到這一點。事實上,我們現在正在這樣做。

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

    當我提到人為因素時,他們正在尋找的另一件事是,他們只是想讓我們證明人們可以實際使用該設備,我們對此也非常有信心,因為他們一直在使用它。因此,您必須進行一些正式的研究。所以這些都不會耽誤我們。 -- 真的,帳篷裡的大桿子正在做註冊批次。我們不能盡快生產的唯一原因是我們必須為我們在 Bausch + Lomb 和 Arctic Vision 的合作夥伴生產用於 MicroPine 的阿托品批次,因為他們正在進行臨床研究,我們需要確保我們可以提供時間。

  • Matthew Lee Kaplan - MD & Head of Healthcare Equity Research

    Matthew Lee Kaplan - MD & Head of Healthcare Equity Research

  • And can you just detail the timeline to -- for those registration batches?

    您能否詳細說明這些註冊批次的時間表?

  • Michael M. Rowe - CEO & Director

    Michael M. Rowe - CEO & Director

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

    是的。因此,我們計劃在明年早些時候完成這些註冊批次,然後進行 12 個月的實時穩定性。一旦我們得到穩定性結果,我們就會將其放入 NDA 中,然後就可以了。

  • Matthew Lee Kaplan - MD & Head of Healthcare Equity Research

    Matthew Lee Kaplan - MD & Head of Healthcare Equity Research

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

    偉大的。好的。然後是最後一個問題——問題。您能否向我們介紹一下 Bausch + Lomb 和 Arctic Vision 在他們的項目上取得的進展,特別是 CHAPERONE III 期的 MicroPine 項目?

  • Michael M. Rowe - CEO & Director

    Michael M. Rowe - CEO & Director

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

    所以博士倫曾公開表示,他們打算在今年年底完成招生。當他們這樣做時,就是 3 年——療效終點。 Arctic Vision 將在我們收到第 2 代設備後立即開始他們的研究,也就是今年晚些時候。我不相信他們的學習是3年。我認為它比 Bausch 的短。所以這兩個可能會在大致相同的時間完成。

  • Operator

    Operator

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

    我們的下一個問題來自 Matthew Caufield 和 H.C.溫賴特。

  • Matthew Coleman Caufield - Associate

    Matthew Coleman Caufield - Associate

  • Great. Can you guys hear me okay?

    偉大的。你們能聽到我說話嗎?

  • Michael M. Rowe - CEO & Director

    Michael M. Rowe - CEO & Director

  • Yes, Matthew.

    是的,馬修。

  • Matthew Coleman Caufield - Associate

    Matthew Coleman Caufield - Associate

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

    驚人的。顯然,主要祝賀 MydCombi 獲得批准。因此,我很好奇團隊對批准後股票看似負面情緒的看法。您認為投資者可能遺漏或誤解了 MydCombi 或 Optejet 整體機會的哪些前景?然後單獨地,我很好奇你是否可以 - 如果 - 抱歉,如果可能需要進一步融資與內部 MydCombi 發布相關聯?

  • Michael M. Rowe - CEO & Director

    Michael M. Rowe - CEO & Director

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

    約翰,你想從那個開始嗎,因為它有點讓人頭疼?

  • John P. Gandolfo - CFO & Secretary

    John P. Gandolfo - CFO & Secretary

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

    是的,當然。所以從整體融資來看——這是一個很好的問題。因此,從整體融資的角度來看,我們有多種融資選擇,包括,正如我提到的,我們可以立即提取 500 萬美元的 Avenue Capital 信貸安排。 Bausch 和 Arctic Vision 對臨床用品的報銷以及合作里程碑或合作或許可機會,我們目前正在努力解決所有這些問題。我們也有傳統的融資機制。

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

    在 MydCombi 發布的融資方面,我們不會建立銷售隊伍。因此,確實存在——我們預計 MydCombi 發布的運營現金消耗與上個季度的運營現金消耗不會有很大不同,上個季度我們的運營現金消耗約為 550 萬美元。

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

    因此,我們將其納入我們所有的現金預測中。我們一直在評估我們在未來的融資方面有哪些選擇。但憑藉我們目前的現金資源,以及我們知道可以動用的資金,我們非常有信心在第二季度到明年第三季度有足夠的現金。所以我希望這能回答你的問題。

  • Michael M. Rowe - CEO & Director

    Michael M. Rowe - CEO & Director

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

    是的。馬修,我想補充一點,因為還有一件事——我想如果你看看其他公司,或者看看他們獲得批准的公司的歷史,可能會有一些人在尋找,他們組建了一支 100 人的銷售隊伍他們基本上開始瘋狂消費。我在其他公司也觀察到這一點,而且我發現這行不通。我們的理念是我們不會過度承諾自己。我們可以非常高效地實現我們的目標。隨著產品的增長,我們可以增加資源並增加支出,以保持它幾乎像火一樣。所以人們可能會擔心,隨著商業支出的大幅增加獲得批准,情況就不會如此了。

  • Operator

    Operator

  • Our next question is from Jason McDonald, Private Investor.

    我們的下一個問題來自私人投資者 Jason McDonald。

  • Jason McDonald

    Jason McDonald

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

    是的。剛吃了一個。邁克爾,這是你的最後一點。當你談到一個混合組織,一些產品在內部,一些產品被外包時,團隊是否真的將技術外包視為更大的收入帶來的長期機會?我的意思是,很明顯,你必須拭目以待。但我很好奇,如果您認為這真的是長期機會,您的頭腦在哪裡?

  • Michael M. Rowe - CEO & Director

    Michael M. Rowe - CEO & Director

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

    謝謝你,傑森,感謝你成為我們的股東和合作夥伴。讓我舉個例子。如果我們談論青光眼的機會,青光眼市場有許多不同的部分。你可以是前列腺素,你可以是 β 受體阻滯劑,你可以是 ROCK 抑製劑等等。因此,看待這個問題的一種方法是,通過與在這些領域擁有不同藥物的不同公司合作,如果我們想用一種產品進入青光眼市場,你實際上可以增加我們自己的機會數量。

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

    因此,我們正在研究其中一些領域,以此作為我們可以擴大我們可以產生的影響並將 Optejet 推廣到那裡的方法。我的意思是它對病人有好處,對醫生有好處,如果我們能在更多情況下使用它,對你作為股東也有好處。這是否回答你的問題?

  • Jason McDonald

    Jason McDonald

  • Yes, makes total sense.

    是的,完全有道理。

  • John P. Gandolfo - CFO & Secretary

    John P. Gandolfo - CFO & Secretary

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

    是的,如果我也可以添加一些東西。當我們考慮結構時,我認為我們更多地將其視為一種夥伴關係類型的機會,我們可以保留很大一部分經濟利益,而不是直接許可類型的協議,在這種情況下你會放棄很多所有的好處。所以我認為,從結構上講,這也是一個重要的區別。

  • Jason McDonald

    Jason McDonald

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

    絕對地。只是對這一點的跟進。當你 - 當涉及到費用時,從長遠來看,你們是否希望保持這個相當小?邁克爾,就像你說的那樣,不要開火,要小心你如何繼續使用這些產品,看看吸收情況如何,也許一個比另一個更好。從這個意義上說,這是保持敏捷的意圖嗎?

  • Michael M. Rowe - CEO & Director

    Michael M. Rowe - CEO & Director

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

    就是這樣。所以我們會看看,也許 2 年後,當我們準備推出 MicroLine 時,我們可能會有 24 名銷售人員。當 MicroLine 起飛時,我們可以增加更多,但我們今天不必承擔這筆費用。

  • Operator

    Operator

  • (Operator Instructions) Our next question is from Robert (inaudible) with RN and Associates.

    (操作員說明)我們的下一個問題來自羅伯特(聽不清)和 RN and Associates。

  • Unidentified Analyst

    Unidentified Analyst

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

    恭喜(聽不清)。我的問題可以追溯到之前的來電者提出的融資問題。可以這麼說嗎——我知道我們都在維持本質上過度稀釋的融資。可以肯定地說,您不會考慮在不久的將來(可能要到 2024 年)進行任何稀釋性融資二次發行或任何事情嗎?

  • John P. Gandolfo - CFO & Secretary

    John P. Gandolfo - CFO & Secretary

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

    好吧,我認為可以肯定地說我們正在做的是我們正在評估那裡的所有機會。我們當然 - 我會告訴你,每當我們考慮為公司融資時,我們的主要重點是以盡可能少的稀釋方式進行。因此,正如我提到的,我們在短期內確實有 Avenue Capital 設施的可用現金以及將要收到的其他一些應收賬款。但我們進行了全面深入的分析。所以我不想說是,我不想說不。但我會告訴你,在融資方面,我們確實有很多選擇。

  • Unidentified Analyst

    Unidentified Analyst

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

    好的。但是現在回答,你沒有決定進行任何二次稀釋產品,對嗎?

  • John P. Gandolfo - CFO & Secretary

    John P. Gandolfo - CFO & Secretary

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

    好吧,截至目前,我們正在評估我們與合作夥伴和所有方面的所有融資機會。但目前還沒有關於融資的絕對確定的決定。

  • Unidentified Analyst

    Unidentified Analyst

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

    好的。你有沒有 - 我不是這個意思 - 就像打敗一匹死馬,但如果你決定這樣做,你認為未來有多遠?

  • John P. Gandolfo - CFO & Secretary

    John P. Gandolfo - CFO & Secretary

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

    目前我還沒有真正考慮過這個問題。我會告訴你,我們會不斷評估我們的備選方案。所以我現在不想承諾任何類似的事情。

  • Unidentified Analyst

    Unidentified Analyst

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

    好的。這只是很多投資者的擔憂,我認為我認為阻止某人投資貴公司的唯一障礙是它是一個因素。這是一個因素。他們不想投資您的公司,因為他們知道在幾週或幾個月內會有二級市場等待上市。這是一個懸垂。如果有一些保證,沒有懸念,我相信在座的每個人都會更加樂觀。並且 - 但我感謝您的回答。你有什麼要補充的嗎?

  • John P. Gandolfo - CFO & Secretary

    John P. Gandolfo - CFO & Secretary

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

    不,我想就是這樣,我們一直在評估我們所有的備選方案。

  • Unidentified Analyst

    Unidentified Analyst

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

    好的。但這可能是您想要使用的最後一個——我從目前所說的內容中收集到的。

  • Michael M. Rowe - CEO & Director

    Michael M. Rowe - CEO & Director

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

    讓我——約翰,如果我可以的話——如果我錯了,請糾正我。正如 John 所提到的,我們的戰略除其他事項外就是發展夥伴關係。顯然,這些合作夥伴關係會帶來一些與之相關的資金。因此,諸如此類的非稀釋性絕對是我們的首選。所以,羅伯特,如果你正在尋找我們的偏好,那就是關閉一個或兩個合作夥伴關係,我們正在努力解決這些問題。然後做這些非稀釋性的,並為最後一個選項保留稀釋性。約翰,這樣說對嗎?

  • John P. Gandolfo - CFO & Secretary

    John P. Gandolfo - CFO & Secretary

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

    是的。聽著,我認為——我認為你正試圖讓我們陷入困境。我要告訴你的是,我們始終希望以盡可能減少稀釋的方式做事。

  • Unidentified Analyst

    Unidentified Analyst

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

    是的我明白。正如你所說,我很高興你有足夠的資金支持你,直到 24 年的第一或第二季度。所以也許暫時不需要這樣做。

  • John P. Gandolfo - CFO & Secretary

    John P. Gandolfo - CFO & Secretary

  • Thank you.

    謝謝。

  • Michael M. Rowe - CEO & Director

    Michael M. Rowe - CEO & Director

  • Thanks.

    謝謝。

  • Operator

    Operator

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

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

  • Leonard Yaffe

    Leonard Yaffe

  • Congrats on the development with MydCombi and all the other success, Michael, that you've enjoyed since you took over as CEO. It's a clear (inaudible) financing to build out the company for all the potential applications that you have, and that shouldn't be a surprise and it should be welcome.

    祝賀 MydCombi 的發展以及所有其他成功,Michael,自從您接任 CEO 以來您一直很享受。這是一項明確的(聽不清)融資,旨在為您擁有的所有潛在應用建立公司,這不足為奇,應該受到歡迎。

  • My question is, given that you've got a study, I believe, through topical that showed the superiority of Optejet versus drops in glaucoma, which are widely prescribed medications, MydCombi clearly seems to benefit both in term (inaudible) they're incentive having to be both, separately and the ease of use and convenience. Could you discuss perhaps the size of the major ophthalmological markets such as glaucoma, where there might be partnership opportunities? Because I think not only would people be interested, but I would expect that the dollar size that would accrue to Eyenovia could be significant to overcome some of the concerns as expressed by the last caller.

    我的問題是,鑑於你有一項研究,我相信,通過局部顯示 Optejet 相對於青光眼下降的優勢,這是廣泛處方的藥物,MydCombi 顯然似乎在長期(聽不清)它們是激勵方面受益必須兩者分開,並且易於使用和方便。您能否討論可能存在合作機會的主要眼科市場(例如青光眼)的規模?因為我認為不僅人們會感興趣,而且我預計 Eyenovia 所積累的美元規模可能會很大,以克服最後一位來電者表達的一些擔憂。

  • Michael M. Rowe - CEO & Director

    Michael M. Rowe - CEO & Director

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

    謝謝你,萊恩。因此,如果我們以青光眼為例,在美國大約有 300 萬至 400 萬青光眼患者實際接受了局部藥物治療。如果你看一下一線治療,它約佔其中的一半,我相信我上次檢查時約為 15 億美元。任何治療青光眼的一線品牌藥物都應該有望賺到 150 [百萬] 到 300 [百萬] 美元。而且這還不算太瘋狂。

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

    從歷史上看,在它們中的許多被通用化之前,它們的產量要多於此。因此,有許多合作夥伴正在尋找這個機會並說,這對我們來說很有意義,特別是如果我們能夠將所有這些好處傳達給患者。我們甚至沒有向醫生提及 Gen2 的潛在好處,因為 Optejet Gen2 中嵌入了電子設備,您可以在其中跟踪合規性和依從性。這就是我們所關注的,這就是我們對此感興趣的原因。我認為一種好的青光眼藥物和 Optejet 基本上可以帶來在這個市場上尋找的整個包裝(聽不清)的人。

  • Operator

    Operator

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

    我們的下一個問題來自亞歷克斯馬修斯 - 他是一名私人投資者。

  • Unidentified Participant

    Unidentified Participant

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

    祝賀你取得了巨大的成就。我只是想了解有關產品營銷的信息。我知道我和我的眼科醫生談過,他沒有聽說過 Optejet。那麼你打算如何讓全國所有的驗光師和眼科醫生知道呢?

  • Michael M. Rowe - CEO & Director

    Michael M. Rowe - CEO & Director

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

    好吧,謝謝你,亞歷克斯,我很高興你的醫生沒有聽說這件事,因為這意味著我的營銷人員提前晉升了。但是現在我們已經獲得批准,下一步就是我們必須讓材料通過 FDA 批准。這需要幾個星期。然後我們將通過電子郵件、社交媒體進行各種會議,然後繼續使用 LinkedIn 或 Instagram 之類的東西。我們在那裡有很大的影響力。我們將能夠把消息傳出去。我還認為,當我們開始將產品放置在這些非常顯眼的辦公室中時,他們都會互相交談,所有的醫生都會開始看到它。

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

    所以你的醫生現在不知道,這很好。我懷疑他或她會在 6 個月後了解該產品。

  • Operator

    Operator

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

    我們的問答環節已經結束。我想將會議轉回給 Michael 以徵求結束意見。

  • Michael M. Rowe - CEO & Director

    Michael M. Rowe - CEO & Director

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

    非常感謝你,接線員。感謝大家今天加入我們,今天的電話會議到此結束。我們希望我們已經表達了我們對即將到來的重大進展和前景的興奮(聽不清)。我們手頭有我們的第一個 FDA 批准。在 MydCombi 的批准下,我們的 MicroLine 老花眼計劃正在取得進展。我們期待著向您更新製造進度以及與潛在未來合作夥伴的討論。再次感謝您加入我們,我們期待今年晚些時候的第二季度更新。再見。

  • Operator

    Operator

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

    謝謝。今天的會議到此結束。此時您可以斷開線路。感謝您的參與。