Eyenovia Inc (EYEN) 2024 Q1 法說會逐字稿

Good afternoon, ladies and gentlemen, and welcome to the Eyenovia first quarter 2024 earnings conference call.

女士們、先生們，下午好，歡迎參加 Eyenovia 2024 年第一季財報電話會議。

At this time, all lines are in listen only mode.

此時，所有線路均處於僅監聽模式。

Following the presentation, we will conduct a question and answer session.

演講結束後，我們將進行問答環節。

(Operator Instructions) This call is being recorded.

（操作員說明）此通話正在錄音。

I would now like to turn the conference over to Mr. Eric Ribner, Head of Investor Relations.

現在我想將會議交給投資者關係主管 Eric Ribner 先生。

Please go ahead.

請繼續。

Good afternoon, and welcome to Eyenovia's first quarter 2024 earnings conference call and audio webcast.

下午好，歡迎參加 Eyenovia 2024 年第一季財報電話會議和音訊網路廣播。

With me today are Eyenovia's Chief Executive Officer, Michael Rowe; Chief Financial Officer, John Gandolfo; and Chief Operating Officer, Bren Kern.

今天與我在一起的有 Eyenovia 執行長 Michael Rowe；財務長約翰‧甘道夫；和首席營運長布倫·科恩。

This afternoon, we issued a press release announcing financial results for the three months ended March 31, 2024.

今天下午，我們發布了新聞稿，宣布截至 2024 年 3 月 31 日止三個月的財務表現。

We encourage everyone to read today's press release as well as Eyenovia's quarterly report on Form 10-Q for the quarter March 31, 2024, which will be filed with the SEC tomorrow.

我們鼓勵大家閱讀今天的新聞稿以及 Eyenovia 2024 年 3 月 31 日季度 10-Q 表格季度報告，該報告將於明天向 SEC 提交。

The company's press release is available on our website at eyenovia.com. In addition, this conference call is being webcast to the company's website and will be archived there for future reference.

該公司的新聞稿可在我們的網站 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。

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

請注意，在今天的電話會議上，我們將討論產品、產品概念和候選產品，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.

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案》的安全港條款管轄。

We caution listeners that during the call, Eyenovia's management will make forward-looking statements and 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.

我們提醒聽眾，在電話會議期間，Eyenovia 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聲明中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 on our annual report and Form 10-K.

這些前瞻性陳述面臨許多風險，我們的年度報告和 10-K 表格對此進行了更詳細的描述。

The conference call contains time-sensitive information that is accurate only as of the date of this live broadcast May 15, 2024.

該電話會議包含時效性訊息，僅截至本次直播直播之日（2024 年 5 月 15 日）準確。

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 the applicable securities law.

Eyenovia 不承擔修改或更新任何前瞻性聲明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 Michael Rowe, Eyenovia's Chief Executive Officer.

話雖如此，我想將電話轉給 Eyenovia 執行長 Michael Rowe。

Michael?

麥可？

Thank you, Eric, and welcome everyone, to our first quarter 2024 financial results conference call.

謝謝艾瑞克，歡迎大家參加我們的 2024 年第一季財務業績電話會議。

During the first quarter, we took several meaningful steps to strengthen the inherent value of our company, which currently includes our novel Optejet dispensing technology.

在第一季度，我們採取了幾項有意義的措施來增強公司的內在價值，其中目前包括我們新穎的 Optejet 點膠技術。

Two FDA approved products, [Mydcombi] and clobetasol and a third MicroPine in late Phase III development.

兩種 FDA 核准的產品，[Mydcombi] 和氯倍他索，以及第三種 MicroPine 處於 III 期開發後期。

Together, these products address the US market worth more than $3.3 billion annually by being able to address a broad range of patient needs with a portfolio of novel technologies and products.

這些產品透過一系列新技術和產品組合滿足廣泛的患者需求，每年銷往價值超過 33 億美元的美國市場。

We believe we are building a solid foundation upon which to drive accelerating sales growth in 2025 and beyond.

我們相信，我們正在為推動 2025 年及以後的銷售加速成長奠定堅實的基礎。

Our main focus is on the successful commercialization of [bid Cami] and clobetasol and the expedited development of MicroPine.

我們的主要重點是 [bid Cami] 和氯倍他索的成功商業化以及 MicroPine 的加速開發。

We are in the process of establishing a solid foundation for our portfolio with a second FDA approved product to be launched by our sales force in the next few months and the potential blockbuster MicroPine in the next couple of years.

我們正在為我們的產品組合奠定堅實的基礎，我們的銷售人員將在未來幾個月內推出第二款 FDA 批准的產品，並在未來幾年內推出潛在的重磅產品 MicroPine。

At the same time, our finance and business development teams are diligently executing on an overall strategy to ensure that Eyenovia is well positioned for success beyond the immediate near term and through these challenging times in the capital markets for small-cap life sciences companies.

同時，我們的財務和業務開發團隊正在努力執行整體策略，以確保 Eyenovia 處於有利地位，能夠在短期內取得成功，並度過資本市場對小型生命科學公司來說充滿挑戰的時期。

Now let's take some time to have up to provide an update on our MicroPine program.

現在讓我們花一些時間來提供 MicroPine 程式的更新。

Which is our Phase III candidate for progressive myopia.

這是我們治療漸進性近視的 III 期候選藥物。

Paediatric progressive myopia has been called an epidemic in the United States and China, where we have licensed the rights to MicroPine to our partner Arctic Vision.

兒童進行性近視在美國和中國被稱為一種流行病，我們已將 MicroPine 的權利授權給我們的合作夥伴 Arctic Vision。

In the US alone, approximately 5 million children for a higher risk of losing functional vision due to this disease for which the eye elongates and can result in separation of the retinal tissues from the back of the eye.

僅在美國，大約有 500 萬兒童因這種疾病而失去功能性視力的風險較高，這種疾病會使眼睛變長，並可能導致視網膜組織與眼睛後部分離。

Third party sources have estimated the value of this market, which currently has no FDA approved drug treatment options at $1.8 billion annually with a similar opportunity in China.

第三方消息來源估計該市場的價值每年為 18 億美元，目前尚無 FDA 批准的藥物治療選擇，而中國也有類似的機會。

The present standard of care involves glasses and contact lenses, which can reduce progression but does not stop it.

目前的護理標準涉及眼鏡和隱形眼鏡，它們可以減少進展，但不能阻止進展。

And these are often not appropriate or well-tolerated by the youngest children who are most at risk.

對於風險最大的最小的孩子來說，這些往往不合適或不能很好地耐受。

And this is where MicroPine can make a significant difference addressing this unmet medical need.

這就是 MicroPine 可以發揮重大作用的地方，解決這個未被滿足的醫療需求。

As a reminder, MicroPine is our investigational eight microliter ophthalmic spray of atropine delivered by the Optejet currently being evaluated as a potential treatment for paediatric progressive myopia in the Chaperone study.

提醒一下，MicroPine 是我們正在研究的 8 微升阿托品眼用噴霧劑，由 Optejet 提供，目前正在 Chaperone 研究中被評估為治療兒童進行性近視的潛在療法。

The results of this study are positive.

這項研究的結果是正面的。

The FDA has agreed that this single four year evaluation could be sufficient for an NDA filing and approval.

FDA 同意，這項為期四年的評估足以滿足新藥申請 (NDA) 的備案和批准。

This is based upon several prior atrophy studies in children in Asia, which demonstrated efficacy in slowing myopia progression by as much as 60%.

這是基於先前對亞洲兒童進行的幾項萎縮研究，這些研究證明可以有效減緩近視進展達 60%。

MicroPine may also offer benefits far beyond what would be obtained with an eye drop.

MicroPine 也可能提供遠遠超出眼藥水所能帶來的好處。

For the Optejet technology children than our in our clinical study as young as six years old are dosing themselves every evening without parental involvement, they can do this because the Optejet doesn't require any head tilting or manipulation of eyedropper bottles that makes any easier with a built-in mirror so that children can see exactly where they are spraying.

對於Optejet 技術的孩子來說，比我們臨床研究中的小六歲的孩子每天晚上都可以在沒有父母參與的情況下自行服藥，因為Optejet 不需要任何頭部傾斜或操作滴管瓶，這使得使用Optejet 技術變得更容易內建鏡子，讓孩子們可以準確地看到他們正在噴灑的地方。

The side effects of that atropine, which have overwhelmingly been mild and transient in our study have been consistent with what we have come to expect with our advanced device and its commercial form.

在我們的研究中，阿托品的副作用絕大多數是輕微且短暫的，與我們對先進設備及其商業形式的預期一致。

We plan to have MicroPine equipped with our OptiCare system, which can notify patients and their parents when to administer their spray dose as well as communicate important compliance and adherence information for the treating

我們計劃讓 MicroPine 配備我們的 OptiCare 系統，該系統可以通知患者及其父母何時施用噴霧劑量，並傳達治療的重要依從性和依從性訊息

[position].

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We are continuing to advance the Phase III Chaperone study and our clinical team is exploring a potential protocol amendments that could greatly expedite the study timelines and registration of MicroPine this protocol amendment will include a planned limited review of the chaperone data by an independent data safety monitoring committee later in the fourth quarter of this year, when approximately two thirds of chaperone patients will have reached the study efficacy endpoint.

我們正在繼續推進 III 期 Chaperone 研究，我們的臨床團隊正在探索潛在的方案修訂，這可以大大加快 MicroPine 的研究時間表和註冊，該方案修訂將包括計劃通過獨立數據安全監測對 Chaperone 數據進行有限審查委員會將在今年第四季稍後召開會議，屆時約三分之二的陪伴患者將達到研究療效終點。

If recommended by the committee, we could potentially be looking at a substantially de-risked program, enabling a potential NDA submission as soon as late 2025 for early 2026, as you can imagine, and we believe this program would then be a very attractive opportunity for commercialization by us for a larger partner.

如果得到委員會的建議，我們可能會考慮一項大幅降低風險的計劃，最早可以在 2025 年末至 2026 年初提交 NDA，正如您所想像的那樣，我們相信該計劃將是一個非常有吸引力的機會由我們為更大的合作夥伴進行商業化。

We are eager to reach that milestone as MicroPine, if approved, with anchor our commercial portfolio and perfectly complement both with [Kambi] and clobetasol, providing significant value to eye doctors, patients and payers by addressing a broad spectrum of unmet needs.

我們渴望實現MicroPine 這一里程碑，如果獲得批准，它將鞏固我們的商業產品組合，並與[Kambi] 和氯倍他索完美互補，透過解決廣泛的未滿足需求，為眼科醫生、患者和付款人提供重大價值。

Now let's talk about what that is all for Pioneer ophthalmic suspension, 0.05% US rights to which we acquired from Taiwan-based Formosa pharmaceuticals last August.

現在讓我們來談談先鋒眼用混懸液的全部內容，我們去年8月從台灣台塑製藥獲得了0.05%的美國權利。

So that is all was approved by the FDA on March 4.

這就是 3 月 4 日 FDA 批准的全部內容。

And in rapid succession, the new drug application or NDA was transferred to us from Formosa.

很快，新藥申請或 NDA 從福爾摩沙轉移給我們。

There have been no new ophthalmic steroids approved in the US in over 15 years.

超過 15 年沒有新的眼用類固醇在美國獲得批准。

The last one was doors all my outcome, which for many years was selling well over $100billion annually for vendors.

最後一個是我的成果，多年來每年為供應商銷售的金額遠遠超過 1000 億美元。

All addresses many of the unmet needs from the ophthalmic steroid for the highly differentiated clinical and pharmacologic profile, including twice-a-day dosing and from a safety standpoint, fewer than 1% of patients experiencing Southern eye pressure increases that may be more common with other steroids.

所有這些都滿足了眼科類固醇在高度差異化的臨床和藥理學特徵方面的許多未滿足的需求，包括每天兩次給藥，並且從安全角度來看，只有不到1% 的患者經歷過南方眼壓升高，這種情況可能更常見於其他類固醇。

Interocular inflammation and eye pressure spikes for the two main safety issues that eye surgeons want to avoid and are paying particular attention to as they can lead to significant clinical consequences, complications and non-reimbursable costs to the providers.

眼間發炎和眼壓高峰是眼外科醫生希望避免並特別關注的兩個主要安全問題，因為它們可能導致嚴重的臨床後果、併發症和醫療服務提供者不可報銷的費用。

We believe that clobetasol has the potential to become the leading option and the post surgical space.

我們相信氯倍他索有潛力成為主要選擇和術後空間。

Unlike conventional steroid drugs, clobetasol was developed using a breakthrough innovation.

與傳統類固醇藥物不同，氯倍他索是採用突破性創新開發的。

And I felt like formulation and active ingredient development.

我喜歡配方和活性成分的開發。

This unique post ocular surgery steroid is the first product developed using Formosis proprietary VTNT nanoparticle formulation platform, which reduces and active pharmaceutical ingredients critical size with high uniformity of surety, thereby allowing penetration to relative relevant compartments in the eye and ultimately enhancing bioavailability.

這種獨特的眼科手術後類固醇是第一個使用Formosis 專有的VTNT 奈米顆粒配方平台開發的產品，該平台可減少活性藥物成分的臨界尺寸，並確保高度均勻性，從而允許滲透到眼睛中的相關相關區室，最終提高生物利用度。

The nanotechnology so effective that essentially makes the suspension act like a solution.

奈米技術非常有效，基本上使懸浮液發揮了溶液的作用。

In fact, patients don't even have to shake the product prior to use and as it's just one of the unique elements of our approved label.

事實上，患者甚至不必在使用前搖晃產品，因為它只是我們批准標籤的獨特元素之一。

And while this might not seem like a big deal.

雖然這看起來似乎沒什麼大不了的。

It does point to the difference between clobetasol and other ophthalmic steroids for [BeVocal] clobetasol efficacy and previously discussed safety profile is another point of differentiation.

它確實指出了氯倍他索與其他眼科類固醇在 [BeVocal] 氯倍他索功效方面的差異，並且之前討論的安全性是另一個區別點。

In clinical studies, nearly nine out of 10 patients achieved complete absence of postsurgical pain and six out of 10 achieved complete absence of inflammation within 15 days post ocular surgery.

在臨床研究中，近十分之九的患者在眼科手術後 15 天內完全消除了術後疼痛，十分之六的患者完全消除了發炎。

And the incidence of all side effects was below 2%.

所有副作用的發生率均低於2%。

Moreover, twice-a-day dosing without titration is a benefit.

此外，每天兩次給藥而無需滴定也是有好處的。

All patients can understand, especially versus other treatments, which require dosing up to four times a day.

所有患者都能理解，特別是與其他治療方法相比，這些治療方法需要每天最多給藥四次。

This is particularly important as eye surgery.

這對於眼科手術尤其重要。

Patients are often on multiple drugs during recovery.

患者在康復期間經常服用多種藥物。

So any advancement which simplifies the treatment regimen would be welcomed by eye doctors and patients alike.

因此，任何簡化治療方案的進步都會受到眼科醫師和患者的歡迎。

It is estimated that there are more than 7 million ocular surgeries in the US each year.

據估計，美國每年有超過 700 萬例眼科手術。

The topical ocular steroids in steroid combinations currently totalling $1.3 billion in sales.

類固醇組合中的局部眼部類固醇目前銷售額總計 13 億美元。

So this is a very significant market opportunity for us and one that we think we can capture a mid-single digit market share over the next three to four years.

因此，這對我們來說是一個非常重要的市場機會，我們認為我們可以在未來三到四年內獲得中個位數的市場份額。

We continued to prepare for a robust commercial launch of Kuvan in Salt Lake through the summer.

整個夏天，我們繼續為 Kuvan 在鹽湖城的商業發布做準備。

And longer-term, we see a potential opportunity to develop a formulation of clobetasol for our Optejet dispenser has a treatment for acute dry eye for that, and we plan to engage with the FDA in the coming months to discuss a path forward in that indication.

從長遠來看，我們看到了為 Optejet 分配器開發氯倍他索配方的潛在機會，可用於治療急性乾眼症，我們計劃在未來幾個月內與 FDA 合作，討論該適應症的前進道路。

Lastly, some of you have asked me about the brand name for clobetasol.

最後，有些人問我氯倍他索的品牌名稱。

That trade name is currently being reviewed by the FDA and we expect a decision from the agency later in June for our launch.

FDA 目前正在審查該商品名，我們預計該機構將在 6 月稍後就我們的上市做出決定。

Staying on the topic of dry eye for a moment.

暫時停留在乾眼這個話題。

In late February, we entered into a collaboration agreement with SGN Nano Pharma.

2月下旬，我們與SGN Nano Pharma簽訂了合作協議。

An innovation, lead clinical-stage Nano Pharmaceutical Company, focusing on creating impactful, best-in-class nano therapeutics, targeting large unmet medical needs, SEN's proprietary, myself, nanoparticle platform, the MNP platform allows for the distribution of an active pharmaceutical ingredient into three or more phases, thereby improving its bioavailability, file distribution and pharmacokinetics.

一家創新、領先的臨床階段奈米製藥公司，專注於創造有影響力的、一流的奈米療法，針對大量未滿足的醫療需求，SEN 專有的奈米顆粒平台，MNP 平台允許分銷活性藥物成分分為三個或更多階段，從而提高其生物利用度、文件分佈和藥物動力學。

For the terms of the agreement, Eyenovia will conduct feasibility and process manufacturing testing that SGN Phase III ready ophthalmic cyclosporine formulation SGN one oh one.

根據協議條款，Eyenovia 將對 SGN III 期眼用環孢素製劑 SGN 進行一一的可行性和製程生產測試。

In combination with the Gen-2 Optejet device as a potential treatment for chronic dry eye.

與 Gen-2 Optejet 設備結合作為慢性乾眼症的潛在治療方法。

Dry eye is a very significant market opportunity with some external sources, valuing that at $3.6 billion annually in the US, a combination of a faster working cyclosporin and the Optejet could be a powerful addition into this large and underserved market for the SGN collaboration, we may have a Phase III ready asset next year in chronic dry eye.

乾眼症是一個非常重要的市場機會，有一些外部來源，在美國每年價值36 億美元，更快起效的環孢菌素和Optejet 的結合可能會成為SGN 合作這個龐大且服務不足的市場的有力補充，我們明年可能會有慢性乾眼症的 III 期資產。

As part of our collaboration, SGN will seek independent funding towards advancing the development of this candidate.

作為我們合作的一部分，SGN 將尋求獨立資金來推動該候選藥物的發展。

I'll now provide an update on with Kambi first and only FDA approved fixed combination of two popular pupil dilation drugs for [Pecem I] and phenylephrine and the first approved ophthalmic spray using the Optejet platform.

我現在將提供有關Kambi 第一個也是唯一一個FDA 批准的兩種流行的瞳孔擴張藥物[Pecem I] 和去氧腎上腺素的固定組合的最新信息，以及第一個使用Optejet 平台批准的眼科噴霧劑。

We are midway through the hiring and training of our 12 person sales force, and we have satisfied state licensing requirements in states covering over two thirds of the US population for the distribution strategy to reach offices in those states where we do not yet have a license.

我們正在招募和培訓 12 名銷售人員，並且我們已經滿足了覆蓋美國三分之二以上人口的州的州許可要求，以便將分銷策略擴展到我們尚未獲得許可的州的辦事處。

The sales force has been out for five weeks now since they're training and they're making inroads into this market.

銷售人員自從接受訓練以來已經外出五個星期了，他們正在進入這個市場。

The sales process requires demonstrating and training the office staff on the use of a copy, which is not difficult, but it's important to make sure that these offices have had great initial experience and realize all of the benefits of the technology to date, they have trained and converted about 50 offices, many of whom you'll see in our social media stream as they talk about their experience with the product.

銷售過程需要演示和培訓辦公室工作人員如何使用副本，這並不困難，但重要的是要確保這些辦公室擁有良好的初步經驗並認識到迄今為止該技術的所有優勢，他們已經對大約50 個辦公室進行了培訓和改造，您可以在我們的社交媒體流中看到其中許多人談論他們的產品體驗。

We have also partnered with these offices in a waiting room promotional campaign showing how they use with Kambi because they care about their patients.

我們也與這些辦公室合作進行候診室促銷活動，展示他們如何使用 Kambi，因為他們關心病人。

And we plan on collecting market research information from the same offices.

我們計劃從同一間辦公室收集市場研究資訊。

So that they can both bolster their own practice satisfaction scores for a number of reasons why offices and institutions like the University of California and premier buying groups like Vision Source have turned to Midcombe.

因此，他們都可以提高自己的實踐滿意度分數，出於多種原因，加州大學等辦公室和機構以及 Vision Source 等頂級採購集團紛紛轉向 Midcombe。

We've been comping the dilation processes.

我們一直在計算膨脹過程。

Neither since the spring amounts is a fraction of what's in the nitrile.

兩者都不是，因為彈簧含量只是丁腈含量的一小部分。

It's comfortable with virtually no stinging report them in clinical studies hygienic with no protruding tip.

它很舒適，幾乎沒有刺痛，臨床研究報告衛生，沒有突出的尖端。

Second accidentally touch one patient and another when using the same model.

其次，在使用相同型號時，不小心觸摸了一名患者和另一名患者。

And it works reliably and quickly to further demonstrate the potential benefits have been Kambi.

它的工作可靠且快速，進一步證明了 Kambi 的潛在優勢。

We recently completed a Phase IV study to characterize the lowest effective dose to achieve mydriasis for certain eye care patients.

我們最近完成了一項 IV 期研究，旨在確定某些眼科護理患者實現散瞳的最低有效劑量。

The current standard of care mydriasis eyedrops could present safety and tolerability risks, including potential systemic cardiovascular side effects of older patients, particularly those with high blood pressure.

目前的散瞳眼藥水治療標準可能有安全性和耐受性風險，包括老年患者（尤其是高血壓患者）潛在的全身性心血管副作用。

In this Phase IV study, 29 subjects were treated with 0.5 dose have been copy for eight microliters per.

在這項 IV 期研究中，29 名受試者接受了 0.5 劑量的治療，每次劑量為 8 微升。

I won't recap all of the positive results again, but two thirds of subjects that treats clinically relevant pupil dilation within 30 minutes post dose and 83% achieved relevant pupil dilation at 60 Minutes post-dose.

我不會再次回顧所有的正面結果，但三分之二的受試者在給藥後30 分鐘內治療了臨床相關的瞳孔擴張，83% 的受試者在給藥後60 分鐘內實現了相關的瞳孔擴張。

Importantly, the lower dose have been Kambi was safe and well-tolerated, with only three subjects supporting mild instillation site pain and one with mild dry eye upon installation.

重要的是，較低劑量的 Kambi 是安全且耐受性良好的，只有三名受試者出現輕微滴注部位疼痛，一名受試者在安裝後出現輕度乾眼症。

And interestingly enough, most patients return to a functional pupil size as soon as 3.5 hours after the drug was used.

有趣的是，大多數患者在使用藥物 3.5 小時後瞳孔大小就會恢復正常。

The duration of pupil dilation is sometimes an issue for patients, especially those that may need to get back to work.

瞳孔擴張的持續時間有時對患者來說是一個問題，尤其是那些可能需要重返工作崗位的患者。

So this finding should help doctors determine what might be best for an individual patient.

因此，這項發現應該可以幫助醫生確定最適合個別患者的方案。

Turning now to our overall sales and marketing and marketing initiatives.

現在談談我們的整體銷售、行銷和行銷計劃。

To complement the efforts of our sales team, we entered into a co-promotion agreement with NovaBay Pharmaceuticals to cross-promote [Coolbet] as all the hundreds of eye care professionals through its telephone-based salesforce.

為了補充我們銷售團隊的努力，我們與 NovaBay Pharmaceuticals 簽訂了一項聯合推廣協議，透過其基於電話的銷售團隊向所有數百名眼保健專業人士交叉推廣 [Coolbet]。

At the same time, our [US] field sales force will promote their prescription Avid Nova anti-microbial lid and lash solution to our doctors who can include this product in their suite of pre and post surgical offerings.

同時，我們的[美國]現場銷售團隊將向我們的醫生推銷他們的處方 Avid Nova 抗菌眼瞼和睫毛解決方案，他們可以將該產品納入他們的手術前和手術後產品套件中。

In addition to the benefit of the promotion and potential sales for both sides, each party will also get a percentage of the sales that they generate.

除了雙方都能獲得促銷和潛在銷售額的好處外，雙方還將獲得其銷售額的一定比例。

This is an extremely cost-effective way to boost our commercial sales reach, and we believe this agreement will be very beneficial to both parties.

這是提高我們商業銷售範圍的一種極具成本效益的方式，我們相信該協議將對雙方都非常有利。

This agreement with NovaBay complements our recent announcement with Vision Source that Vision Source has added been Kambi as an approved product for its membership of more than 3,000 locally own optometry offices.

與 NovaBay 的這項協議是我們最近與 Vision Source 的聲明的補充，即 Vision Source 已將 Kambi 添加為其 3,000 多家當地驗光辦公室會員的批准產品。

So while our own sales force is targeted, this agreement allows us to significantly expand our commercial reach, particularly in more rural areas where we may not be providing direct sales coverage.

因此，雖然我們自己的銷售團隊是有針對性的，但該協議使我們能夠顯著擴大我們的商業覆蓋範圍，特別是在我們可能無法提供直接銷售覆蓋的更多農村地區。

Currently, we are already seeing sales have been coming division source member offices before turning the call over to Brent to provide a manufacturing update.

目前，我們已經看到銷售已來自部門源成員辦公室，然後將電話轉給布倫特以提供製造更新。

I will conclude with a recap of recent national ophthalmology medical meetings that we participate today.

最後，我將回顧我們今天參加的最近的全國眼科醫學會議。

The first was the American Society of Cataract and Refractive Surgery annual meeting or ASCRS in Boston.

第一場是在波士頓舉行的美國白內障和屈光手術協會年會（ASCRS）。

During ASCRS, we featured our entire suite of commercial products with Kambi, clobetasol and Epanova.

在 ASCRS 期間，我們展示了我們的整套商業產品，包括 Kambi、氯倍他索和 Epanova。

Both our sales and medical affairs teams will present to demonstrate the products review data answer questions and provide attendees with the opportunity to purchase these products on site.

我們的銷售和醫療事務團隊將展示產品審查數據並回答問題，並為與會者提供現場購買這些產品的機會。

We also attended Vision Source exchange in Orlando, Vision Source exchanges, the country's largest gathering of private practice optometrists with more than 1,000 of the most successful ODs in the nation.

我們也參加了在奧蘭多舉行的 Vision Source 交流會，Vision Source 交流會是美國最大的私人執業驗光師聚會，擁有 1,000 多名全國最成功的驗光師。

The event featured continuing education keynote speakers exchange early pricing for more than 100 vendors and opportunities to network with college who were on hand to demonstrate and settlement can be there as well.

該活動的特色是繼續教育主講人為 100 多家供應商交換了早期定價，並提供了與現場演示的大學建立聯繫的機會，並且也可以在那裡進行結算。

And just recently, we delivered the presentation at the Association for Research in Vision and Ophthalmology 2024 Annual Meeting or RFO for presentation detailed results from a study demonstrating that for most of the APNT technology on which the development of Covance always base improve the solubility and bioavailability of topical ophthalmic medications.

就在最近，我們在視覺與眼科研究協會2024 年年會或RFO 上發表了演講，展示了一項研究的詳細結果，該研究表明，對於科文斯開發始終基於的大多數APNT 技術，可提高溶解度和生物利用度局部眼科藥物。

APNT much like our Optejet dispenser represents an exciting new film technology, and we are thrilled to feature both in our product portfolio, our presence at National Medical and Commercial meetings like these are key to raising awareness of the breadth of our product portfolio and are a critical component of our commercialization strategy.

APNT 與我們的Optejet 分配器非常相似，代表了一種令人興奮的新薄膜技術，我們很高興能夠在我們的產品組合中展示這兩種技術，我們參加此類國家醫療和商業會議是提高人們對我們產品組合廣度的認識的關鍵，並且是我們商業化策略的重要組成部分。

We plan to attend more such meetings later this year.

我們計劃今年稍後參加更多此類會議。

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

此時，我想將電話轉給我們的營運長 Bren Kern，以了解我們的製造最新情況。

Brian?

布萊恩？

Thank you, Michael.

謝謝你，麥可。

As previously mentioned by Michael, with our sales staff configuring their training, we are experiencing an uptick in the economy sales orders.

正如邁克爾之前提到的，隨著我們的銷售人員配置他們的培訓，我們正在經歷經濟銷售訂單的上升。

Our operations team is working closely with our commercial team to ensure that our growing customer base is being provided with best in class customer service enabled by the procurement of state licensing covering two thirds of the US population are women at City facility serves as our primary distribution center for Net company.

我們的營運團隊正在與我們的商業團隊密切合作，以確保為我們不斷增長的客戶群提供一流的客戶服務，透過購買覆蓋美國三分之二人口的女性的國家許可，城市設施是我們的主要分銷商網絡公司的中心。

Redwood City is supported by manufacturing visionary supply chain, quality and regulatory professionals.

紅木城得到了富有遠見的製造業供應鏈、品質和監管專業人員的支持。

All of them are laser focused on order fulfillment.

所有這些都專注於訂單履行。

Recognize their integral role in terms of customer satisfaction are fuelled by the excitement of providing clinical practices across the country with our ground breaking technology, manufacturing operations have been performing to expectations, and supply of [Maconomy] remains sufficient to fulfill current sales demand.

認識到他們在客戶滿意度方面不可或缺的作用是透過我們的突破性技術在全國範圍內提供臨床實踐的興奮推動的，製造業務一直按預期進行，並且[Maconomy] 的供應仍然足以滿足當前的銷售需求。

In addition to distributing amid Kambi Redwood City will also be leveraged as the initial distribution hub for clobetasol.

除了在卡比紅木城進行分銷外，紅木城還將被用作氯倍他索的最初分銷中心。

Our operations team is actively optimizing distribution processes in preparation of product receipts for most of pharmaceuticals has initiated the manufacture of clobetasol and is on schedule for delivery and our subsequent shipment later this summer.

我們的營運團隊正在積極優化分銷流程，準備大多數藥品的產品收據，已開始生產氯倍他索，並按計劃於今年夏天晚些時候交付和後續發貨。

These preparatory activities are currently progressing as planned.

目前，這些準備工作正在按計劃進行。

Our facility in Reno was in part selected to support the future distribution of Eyenovia products as it contains warehousing infrastructure conducive to the proper storage and handling of drug product.

我們在裡諾的設施部分是為了支持 Eyenovia 產品的未來分銷而選擇的，因為它包含有利於正確儲存和處理藥品的倉儲基礎設施。

The renal operations team also comprised of manufacturing engineering supply chain and quality.

腎臟運作團隊還包括製造工程供應鏈和品質部門。

We're actively installing and validating systems similar to those in Redwood City for a larger scale.

我們正在積極大規模地安裝和驗證與紅木城類似的系統。

When complete this increased storage capacity will be complementary to Redwood City and provides us with the flexibility to handle future fulfillment needs.

完成後，增加的儲存容量將與紅木城形成互補，並為我們提供處理未來履行需求的靈活性。

To this end, we are also establishing internal logistics capabilities along the transportation of materials between the two locations, unbridled by large commercial shipping companies.

為此，我們還在兩個地點之間建立不受大型商業航運公司限制的材料運輸的內部物流能力。

Eyenovia is also progressing with plans to introduce Jim two into the commercial market, our Redwood City facility, which houses steady Arch, clean rooms and aseptic fill-and-finish operations is currently preparing for the production of registration batches required for future SNDA submission.

Eyenovia 也正在推動將 Jim 2 引入商業市場的計劃，我們的紅木城工廠擁有穩定的 Arch、無塵室和無菌填充和完成操作，目前正在準備生產未來 SNDA 提交所需的註冊批次。

These preparations include market improvements aimed at increasing performance and efficiencies.

這些準備工作包括旨在提高績效和效率的市場改善。

Our engineering team is also hurting or planning, testing, refining and generating documentation to support the Gen-2 platform.

我們的工程團隊也在規劃、測試、完善和產生文件以支援 Gen-2 平台。

These activities bears significant similarities to our Gen-1 platform and our FDA inspection successes with GEN-1, combined with an ever increasing technological knowledge base suggests the successes, but Gen-1 will be replicated for Gen-2.

這些活動與我們的 Gen-1 平台和 FDA 對 GEN-1 的成功檢查具有顯著相似之處，再加上不斷增長的技術知識庫表明了成功，但 Gen-1 將被複製到 Gen-2。

Further to the expansion of our capacity.

進一步擴大我們的產能。

The Reno facility has optimized our new injector manufacturing process, culminating in executing process validation builds for product generated during this build.

裡諾工廠優化了我們新的噴油嘴製造流程，最終對該建置期間產生的產品執行流程驗證建置。

As we prepare for preparing and testing the feasibility test results suggest that product should be should perform as expected, a classified these achievements as impresses me Kambi has entered into the commercial market and is being well received, demonstrating the Optejet platform is capable and both the technology and our processes are able to fulfil the rigorous standards established by regulatory bodies in scale.

當我們準備準備和測試可行性測試結果表明產品應按預期運行時，這些成就給我留下了深刻的印象，Kambi 已進入商業市場並受到好評，這表明 Optejet 平台有能力，而且技術和我們的流程能夠大規模滿足監管機構制定的嚴格標準。

I would now like to turn the call over to our Chief Financial Officer, John Gandolfo to provide an update 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。

John?

約翰？

Thanks, Brent.

謝謝，布倫特。

For the first quarter of 2024, we reported net loss of approximately $10.9 million or $0.23 per share on approximately [$46.6 million] weighted average shares outstanding.

2024 年第一季度，我們公佈的加權平均已發行股票淨虧損約為 1,090 萬美元，即每股 0.23 美元，淨虧損約為 [4,660 萬美元]。

This includes a $0.05 loss related to the $2.5 million of costs for bringing microbial back to Eyenovia.

其中包括與將微生物帶回 Eyenovia 的 250 萬美元成本相關的 0.05 美元損失。

First Quarter 2024 net loss compared to a net loss of $5.7 million or $0.15 per share and approximately [$37.4 million] weighted average shares outstanding for the first quarter of 2023.

2024 年第一季淨虧損，而 2023 年第一季的淨虧損為 570 萬美元或每股 0.15 美元，加權平均已發行股數約為 [3,740 萬美元]。

Research and development expenses totalled approximately $4.4 million for the first quarter of 2024, and this compares to $2.5 million for the first quarter of 2023, an increase of 75.7%.

2024 年第一季的研發費用總計約為 440 萬美元，而 2023 年第一季的研發費用為 250 萬美元，成長了 75.7%。

For the first quarter of 2024 G&A expenses were approximately $3.8 million as compared to $2.9 million for the first quarter of 2023, an increase of 30.6%.

2024 年第一季的一般管理費用約為 380 萬美元，而 2023 年第一季為 290 萬美元，成長了 30.6%。

Total operating expenses for the first quarter of 2024 were approximately $10.3 million, including the previously mentioned $2.5 million in repatriation costs.

2024 年第一季的總營運費用約為 1,030 萬美元，其中包括先前提到的 250 萬美元的匯回費用。

For bringing MicroPine back to Eyenovia.

感謝將 MicroPine 帶回 Eyenovia。

This compares to $5.5 million for the same period in 2023 and represents an increase of approximately 88% our first quarter 2024 operating expense figure also included approximately $1.5 million of non-cash expenses.

與 2023 年同期的 550 萬美元相比，我們 2024 年第一季的營運支出數字增加了約 88%，其中還包括約 150 萬美元的非現金支出。

On March 31, 2024, we reported unrestricted cash of approximately $8 million, and this does not include the $2.2 million of additional capital the Company raised in April of 2024.

2024 年 3 月 31 日，我們報告了約 800 萬美元的無限現金，這不包括公司在 2024 年 4 月籌集的 220 萬美元額外資本。

We have reduced our planned spending by approximately $800,000 per quarter compared to the first quarter of 2024 cash-based operating expense levels.

與 2024 年第一季基於現金的營運費用水準相比，我們每季的計畫支出減少了約 80 萬美元。

And we're focusing our resources on validating our Gen-2 device with the FDA commercializing mid Cambian for better saw the completion of the MicroPulse Chaperone study.

我們正在集中資源，透過 FDA 驗證我們的 Gen-2 設備，將 Cambian 中部商業化，以便更好地完成 MicroPulse Chaperone 研究。

We are also exploring several options and structures to ensure we have sufficient capital to support these programs and continue to execute that growth strategy.

我們也正在探索多種選擇和結構，以確保我們有足夠的資本來支持這些計劃並繼續執行該成長策略。

I'll now provide an update on our existing licensing programs with Arctic Vision, which covers all three of our products in China and South Korea, MicroLine or a pressure and Maconomy and provides the sales royalties in addition to development milestones, MicroPine, in particular, significant opportunity in China for paediatric myopia.

我現在將提供有關Arctic Vision 的現有許可計劃的最新信息，該計劃涵蓋我們在中國和韓國的所有三種產品、MicroLine 或壓力和Maconomy，並提供除開發里程碑外的銷售特許權使用費，特別是MicroPine ，中國兒童近視的重大機會。

If approved, MicroPatent could be a potentially meaningful source of non-dilutive funding for our company over the long-term.

如果獲得批准，從長遠來看，MicroPatent 可能成為我們公司潛在的、有意義的非稀釋性資金來源。

To data license agreements have generated approximately $16 million in license fees, and we have the potential to earn an additional $25 million in non-dilutive net license and development milestones from Arctic Vision over the next three to four years.

數據許可協議已產生約 1600 萬美元的許可費，並且我們有潛力在未來三到四年內從 Arctic Vision 獲得額外 2500 萬美元的非稀釋淨許可和開發里程碑。

If our products are approved upon commercialization, we also are eligible to earn significant sales royalties as well.

如果我們的產品在商業化後獲得批准，我們也有資格獲得可觀的銷售特許權使用費。

We are also continuing to assess potential pipeline expansion opportunities similar to our promotion agreements, and we will continue to leverage the Optejet technology to address unmet needs in additional large ophthalmic indications beginning with dry eye.

我們也正在繼續評估潛在的管道擴張機會，類似於我們的促銷協議，我們將繼續利用 Optejet 技術來解決從乾眼開始的其他大型眼科適應症的未滿足需求。

As Michael indicated earlier, we believe the steps that we have taken to date to create a solid foundation upon which we will drive meaningful sales growth in 2025 and beyond.

正如邁克爾早些時候指出的那樣，我們相信迄今為止所採取的步驟為我們將在 2025 年及以後推動有意義的銷售成長奠定了堅實的基礎。

In conclusion, we are very pleased with our performance in the first quarter of 2024.

總之，我們對 2024 年第一季的表現非常滿意。

And to summarize our key highlights today, we announced FDA approval of clobetasol for the treatment of pain and inflammation.

總結一下今天的主要亮點，我們宣布 FDA 批准氯倍他索用於治療疼痛和發炎。

Following ocular surgery, we reacquired the development and commercial rights to MicroPine for the US and Canada.

眼科手術後，我們重新獲得了 MicroPine 在美國和加拿大的開發和商業權利。

We entered into a co-promotion agreement with NovaBay Pharmaceuticals, whereby NovaBay will market clobetasol through its US physician dispense channel.

我們與 NovaBay Pharmaceuticals 簽訂了一項聯合推廣協議，根據該協議，NovaBay 將透過其美國醫生配藥管道銷售氯倍他索。

The agreement also gives us access to their prescription Eyenovia, antimicrobial lid and lash solution.

該協議還使我們能夠獲得他們的處方 Eyenovia、抗菌眼瞼和睫毛溶液。

We announced that our second manufacturing facility in Redwood City, California has been approved by the FDA as a commercial manufacturing facility.

我們宣布位於加州雷德伍德城的第二個製造工廠已獲得 FDA 批准作為商業製造工廠。

We've participated in three important national ophthalmology medical meetings, ASCRS Vision Source exchange and ARVO., which provides excellent platforms for us to demonstrate our commercial products and educate doctors on their use.

我們參加了三個重要的全國眼科醫學會議，ASCRS Vision Source Exchange 和 ARVO.，這為我們展示我們的商業產品和教育醫生使用提供了很好的平台。

And finally, our licensing agreement with Arctic Vision is progressing well and remains a promising avenue for significant development and regulatory milestones, as well as the potential for sales royalties in the future.

最後，我們與 Arctic Vision 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未來銷售特許權使用費潛力的有希望的途徑。

That concludes our prepared remarks.

我們準備好的演講到此結束。

We would like to now open the call to questions.

我們現在開始接受提問。

Operator?

操作員？

Thank you.

謝謝。

Ladies and gentlemen, we will now begin the question and answer session.

女士們、先生們，我們現在開始問答環節。

(Operator Instructions)

（操作員說明）

Matt Kaplan, Ladenburg.

馬特卡普蘭，拉登堡。

Hey, guys, thanks for taking the question and congrats on the progress during the quarter.

嘿，夥計們，感謝您提出問題，並祝賀本季度的進展。

And can you talk a little bit more about the transition that you're planning to the Gen-2 device and on for your portfolio of products and what you think it will take to get the thumbs-up from FDA for that

您能否多談談您計劃向 Gen-2 設備和產品組合的過渡，以及您認為如何才能獲得 FDA 的認可

[size].

[尺寸]。

Yes, Hi, Matthew, and thank you for calling in from.

是的，嗨，馬修，感謝您打電話來。

There's basically two things we need to do.

基本上我們需要做兩件事。

The first is we have to demonstrate that the Gen-2 packs like the Gen-1 in terms of performance, how much drug it delivers, how it delivers the drug and so on.

首先，我們必須證明 Gen-2 包裝在性能、輸送藥物量、輸送藥物方式等方面與 Gen-1 相似。

And Bren and his team is deep in doing that.

布倫和他的團隊正在深入這樣做。

The second thing that we believe the FDA is going to ask for is a very small bridging study that we can essentially do in three days just to give them the additional knowledge that when people actually use us in real, they get the same result.

我們相信FDA 會要求的第二件事是一項非常小的橋接研究，我們基本上可以在三天內完成這項研究，只是為了讓他們了解更多的知識，即當人們實際使用我們時，他們會得到相同的結果。

And like I said, that's literally a three day study that could be done while we're manufacturing a Gen-2 supply.

正如我所說，這實際上是一項為期三天的研究，可以在我們製造第二代電源時完成。

So at this point, our plan is we've already submitted for the FDA meeting, we would like, but likely have that meeting in mid-July.

所以目前，我們的計劃是我們已經提交了 FDA 會議的申請，我們希望，但可能會在 7 月中旬舉行該會議。

Assuming that goes as we believe it will, we will make the Gen-2 supply shortly thereafter, while that supply is up is up for stability, which is 12 months, we will complete a small bridging study.

假設情況如我們所相信的那樣，我們將在不久之後提供 Gen-2 供應，而供應量是為了穩定而增加的，即 12 個月，我們將完成一項小型橋接研究。

And then basically we take all that information and file an SNDA, which I believe has a six month turnaround to it so that by the end of next year, we may be ready to go into the market with the Gen-2.

然後基本上我們會獲取所有這些資訊並提交 SNDA，我相信該文件有六個月的周轉時間，以便到明年年底，我們可能準備好將 Gen-2 推向市場。

But the good news is that I believe we've got all the boxes checked.

但好消息是我相信我們已經檢查了所有的方框。

And I'm feeling very confident that we're going to be able to do this, and it's not going to be anything that's going to be difficult for us.

我非常有信心我們能夠做到這一點，而且這對我們來說不會是困難的事情。

Bren did I miss anything?

布倫 我錯過了什麼嗎？

No, Michael, Perfectly.

不，邁克爾，完美。

Thank you.

謝謝。

Okay.

好的。

And then and then just a second question and on [Micropine], you plan to meet with the FDA soon.

然後再問第二個問題，關於 [Micropine]，您計劃很快與 FDA 會面。

When do you think you'll have that squared away in terms of the protocol amendment and be able to do that analysis in the fourth quarter?

您認為什麼時候可以在協議修正案方面解決這個問題，並且能夠在第四季度進行分析？

Right.

正確的。

Well, my clinical and regulatory team tells me that we can do the protocol amendment without missing without meeting with the FDA because we're putting in place a data monitoring committee.

嗯，我的臨床和監管團隊告訴我，我們可以在不與 FDA 會面的情況下完成方案修訂，因為我們正在設立一個資料監測委員會。

So we at Eyenovia do not actually see the results.

所以我們 Eyenovia 實際上並沒有看到結果。

And so the DMC would then look at the data probably in mid-October.

因此，DMC 可能會在 10 月中旬查看數據。

And basically they come out of that meeting with a thumbs up that everything looks great for, for example, in the very rare case that nothing's happening will be a thumbs down to pull us back.

基本上，他們在會議結束後都會豎起大拇指，認為一切看起來都很好，例如，在極少數情況下，什麼也沒有發生，就會豎起大拇指將我們拉回來。

But basically, they give us the indication of whether or not there's something there now from looking at the masked data, my team certainly thinks there's a very, very good signal, and that's why we're optimistic about this.

但基本上，他們透過查看屏蔽數據向我們表明現在是否存在某些東西，我的團隊當然認為存在一個非常非常好的信號，這就是我們對此持樂觀態度的原因。

And the DMC would then confirm that.

DMC 隨後會確認這一點。

And then once they do confirm that, that's when we meet with the FDA and we say, look, this is what we have.

一旦他們確認了這一點，我們就會與 FDA 會面，我們說，看，這就是我們所擁有的。

This is what the DMC said we have the statistical power at this point.

這就是 DMC 所說的，我們目前擁有統計能力。

This is why we would like to stop the study and go right into the analysis.

這就是為什麼我們要停止研究並直接進行分析。

So that would probably happen if the DMC meets in October.

因此，如果 DMC 在 10 月召開會議，這種情況可能會發生。

It would be one or two months after that.

那會是一兩個月之後。

Okay.

好的。

That makes sense.

這就說得通了。

Great, thanks for taking the questions.

太好了，感謝您提出問題。

Thank you, Matt.

謝謝你，馬特。

Matthew Canfield, H.C. Wainwright.

馬修‧坎菲爾德，H.C.溫賴特。

Thank you, Michael and team, and thanks for taking our questions and exciting to see the new commercial opportunities here in the near term.

謝謝邁克爾和團隊，感謝您提出我們的問題，並很高興看到短期內這裡的新商業機會。

So actually for Thank you until for Optejet development in presbyopia with aperture, I believe it's or raises pharma that that's planning their pilocarpine launch for first half '24.

所以實際上謝謝你，直到 Optejet 在老花眼中的開發，我相信它或提高製藥公司計劃在 24 年上半年推出毛果芸香鹼。

And I was curious what you'd want to see in the near term, kind of what you'd like to see from that from the overall presbyopia market to have [apperture] should be more of a top strategic priority.

我很好奇您在短期內希望看到什麼，您希望從整個老花眼市場中看到什麼，[光圈]應該更多地成為首要戰略優先事項。

And then I just had one follow-up on the Gen-2 device.

然後我剛剛對第二代設備進行了後續行動。

Great, Matthew, thank you.

太好了，馬修，謝謝你。

It's a great question so right now, I believe you have the which is the only product approved in the market is selling somewhere between $15 million and $18 million a year, which obviously was underperforming with everybody had hoped for.

這是一個很好的問題，所以現在，我相信您擁有的產品是市場上唯一獲得批准的產品，每年的銷售額在 1500 萬至 1800 萬美元之間，這顯然沒有達到每個人的預期。

So if or assist or anybody can go out there and we start seeing a market that starts to grow and gets to $50 million or $100 million that would obviously be very attractive to us.

因此，如果或協助或任何人可以走出去，我們就會開始看到一個開始成長並達到 5,000 萬或 1 億美元的市場，這顯然對我們非常有吸引力。

There's two things going on here.

這裡發生了兩件事。

One is that people are looking at the efficacy and side effect of these products, but the other thing is also people like the Optejet.

一是人們關注這些產品的功效和副作用，但二是人們也喜歡Optejet。

So the eye drops that are going to be out.

所以眼藥水就要出來了。

There will likely all compete on who last the longest and who has the fewest side effects, we are completely different by having the Optejet, which end market research, the vast majority of potential users.

或許大家都會競爭誰的持續時間最長，誰的副作用最少，我們完全不同，因為擁有 Optejet，它結束了市場研究，絕大多數潛在用戶。

They just like the device for all sorts of reasons.

他們出於各種原因喜歡該設備。

Its need and doesn't mess up, make up the screen and socially acceptable lots of reasons to use that.

它的需要並且不會弄亂，彌補螢幕和社會上可接受的許多使用它的理由。

But to go into this market right now and the spend $20 million or $30 million doesn't make sense to me not in the market of this size.

但現在進入這個市場並花費 2000 萬或 3000 萬美元對我來說沒有意義，因為在如此規模的市場中。

So we are very comfortable with letting other people go in there, spend the resources build this up to a point where we can say, okay, Greg, you've done a great job with the eye drops.

因此，我們非常樂意讓其他人參與進來，花費資源將其建立到我們可以說，好吧，格雷格，你在滴眼劑方面做得很好。

We can come in with something completely different, completely differentiated that we know people like and you've done the heavy lifting for us.

我們可以推出一些完全不同、完全與眾不同的東西，我們知道人們喜歡這些東西，而您已經為我們完成了繁重的工作。

So that's what we'll be looking for.

這就是我們要尋找的。

Very helpful.

很有幫助。

And I think that definitely makes sense strategically.

我認為這在戰略上絕對有意義。

And then just one question on the Gen two device.

然後是關於第二代設備的一個問題。

So for the Gen two Optejet, can you remind us if that focuses squarely on the paediatric myopia program?

那麼對於第二代 Optejet，您能否提醒我們，它是否直接專注於兒童近視項目？

Or is there any chance that the Gen-2 device could be relevant for the current [MidCon], the mydriasis approval.

或者 Gen-2 設備是否有可能與目前的 [MidCon]（瞳孔散大批准）相關。

So Gen-2 ultimately will be our only platform.

所以 Gen-2 最終將成為我們唯一的平台。

The reason that run, okay, we had forced Yes, first admit in Midcombe has because that's our only approved product.

運行的原因是，好吧，我們強迫是的，首先在 Midcombe 承認，因為這是我們唯一批准的產品。

So we have to we have to measure it and validated it against an approved product, which has been David.

因此，我們必須對其進行測量，並根據已批准的產品（大衛）進行驗證。

But what it does Matt is by doing it against Mid-Con, the all of the stuff we have to do with performance testing and validation, it's basically identical for all the other programs.

但馬特的作用是針對 Mid-Con，我們必須做的所有效能測試和驗證工作，對於所有其他程式來說基本上都是相同的。

So we basically have the recipe that the FDA has accepted so that when we get to the other products, the other one be MicroPine, we just follow the same recipe.

因此，我們基本上擁有 FDA 接受的配方，因此當我們使用其他產品時，另一個產品是 MicroPine，我們只需遵循相同的配方。

Got you.

明白你了。

Understood.

明白了。

Thank you very much guidance and congrats again.

非常感謝您的指導並再次祝賀。

Thank you.

謝謝。

Kemp Dolliver, Brookline Capital Markets.

Kemp Dolliver，布魯克林資本市場。

Thanks and good evening.

謝謝，晚上好。

First is how should we think about the runway situation given the reduction in spending and other adaptations to your plan?

首先是考慮到支出的減少和計劃的其他調整，我們應該如何考慮跑道情況？

John, do you want to take that?

約翰，你想接受這個嗎？

So the way we're looking at is have we feel our current cash plus reimbursement from our partners for again, to product development expenses as well as the launch of clobetasol.

因此，我們正在考慮的方式是，我們是否感受到我們目前的現金加上我們合作夥伴的補償，以用於產品開發費用以及氯倍他索的推出。

That 60% gross margin gives us cash resources that are sufficient.

60%的毛利率為我們帶來了充足的現金資源。

So we get that data readout on MicroPine, which Michael mentioned is to have towards the latter part of fourth quarter of 2024.

因此，我們在 MicroPine 上獲得了數據讀數，Michael 提到該數據將在 2024 年第四季下半年獲得。

In addition, as I mentioned in our prepared remarks, we're exploring various options and structures to ensure that we have enough capital and support pass that point.

此外，正如我在準備好的演講中所提到的，我們正在探索各種選擇和結構，以確保我們有足夠的資本和支持來實現這一目標。

So yes, I think that's probably the best way to look at it in terms of the reduced cash spending that we put in place.

所以，是的，我認為這可能是從我們減少現金支出的角度來看待它的最佳方式。

I think that was just down business principle that we felt like we should reduce wherever we could.

我認為這只是商業原則，我們認為我們應該盡可能減少。

One final comment with respect to our cash-based expenses is that a large amount of our expenses are project-based.

關於我們基於現金的支出的最後一個評論是，我們的很大一部分的支出都是基於專案。

So if needed, we could just defer some of that spending on some of those longer-term projects.

因此，如果需要，我們可以推遲一些長期項目的部分支出。

Now we don't believe that that's necessary or we haven't planned for it, but it is important to note that we do have flexibility with our spending going forward too.

現在我們認為這是沒有必要的，或者我們還沒有計劃這樣做，但重要的是要注意，我們在未來的支出方面也確實具有靈活性。

Thank you.

謝謝。

I would also add to that in my comments about SGN., for example, that we are getting partners out now that when they come in, they basically also come in with the funding to do the development rather than us having to come up with that.

我還想在我對 SGN 的評論中補充一點，例如，我們現在正在讓合作夥伴退出，當他們進來時，他們基本上也會提供資金來進行開發，而不是我們必須拿出來。

So that opportunity without advanced quick acting cyclosporine for dry eye SGN is doing a great job in raising that money so that we can do our work, which is the sweat work to get it done, but they're going to be able to bring much of that cash in.

因此，在沒有先進的速效環孢素治療乾眼症的情況下，SGN 在籌集資金方面做得很好，這樣我們就可以完成我們的工作，這是完成工作的汗水工作，但他們將能夠帶來很多這筆現金。

Great.

偉大的。

Thank you.

謝謝。

And with regard to Gen-2, are we still dependent upon Gen-2 to get a cost of goods structure that we'll help you achieve profitability, John?

關於 Gen-2，我們是否仍然依賴 Gen-2 來獲得我們將幫助您實現盈利的商品成本結構，約翰？

Yes, exactly the.

是的，正是如此。

So to give you an idea, the one of the main main reasons why we will look for FDA approval of Maconomy with gem.

因此，給您一個想法，這是我們尋求 FDA 批准 Maconomy 與 gem 的主要原因之一。

One is we wanted to go through the regulatory process and get approval with a product that had never been done before.

一是我們希望通過監管流程並獲得以前從未做過的產品的批准。

And our our focus was always going to be to develop a commercial product, which is Gen-2, as you stated, at a much more efficient cost of goods sold.

我們的重點始終是開發一種商業產品，即 Gen-2，正如您所說，以更有效的銷售成本。

So to give you an example, the of the cost of goods sold on the Gen-2 delivery system, it's probably about 20% of the cost of goods sold of the Gen-1 system.

舉個例子，在 Gen-2 交付系統上銷售的商品成本可能是在 Gen-1 系統上銷售的商品成本的 20% 左右。

So it makes all of our programs generate gross margins between at the low end, probably 60% to 70% at the high end with MicroPatent north of 90%.

因此，這使得我們所有項目的毛利率介於低端（可能為 60% 至 70%）和高端（MicroPatent 的 90% 以上）之間。

So that is going to be the key driver that gets the companies to profitability.

因此，這將成為公司實現盈利的關鍵驅動力。

Okay, great.

好的，太好了。

And how is the Formosa doing with getting the export approval worked out?

台塑出口審核進度如何？

That's funny.

那很好笑。

You asked that.

你這麼問了。

So the Taiwanese FDA was in there doing their inspections there now waiting for their final report.

所以台灣食品藥物管理局正在那裡進行檢查，現在等待他們的最終報告。

I I've been told by my partners in Taiwan that you can push them too hard so we don't do that.

我在台灣的合作夥伴告訴我，你可以把他們逼得太緊，所以我們不會這麼做。

But in the meantime, we have the labelling ready.

但同時，我們已準備好標籤。

We have all the other preparations ready and we're doing everything we can.

我們已經做好了所有其他準備工作，並且正在盡一切努力。

So the minute they get that permit, they can drop the pallets off at the airport and send them over to us.

因此，一旦他們獲得許可證，他們就可以將托盤放在機場並將其發送給我們。

Right now.

現在。

We're counting on that happening somewhere in early to mid July.

我們預計這會在七月初至中旬發生。

So that our plan is we want to be on the street by August 1.

所以我們的計劃是我們希望在 8 月 1 日之前走上街頭。

Great.

偉大的。

Thanks so much.

非常感謝。

Thank you again, there are no further questions at this time.

再次感謝您，目前沒有其他問題。

I would now like to hand the call over to Mr. Michael Rowe.

我現在想將電話轉交給邁克爾·羅先生。

Please go ahead.

請繼續。

Thank you, operator, and thanks to everybody on the call today and through the development of Eyenovia, our company.

謝謝您，接線員，感謝今天參加電話會議的每個人以及我們公司 Eyenovia 的發展。

Now has two FDA approved products, both very differentiated and well positioned in the eye care space.

現在有兩種 FDA 批准的產品，兩者都非常差異化並且在眼部護理領域定位良好。

Our platform technology, the Optejet is going to be presented to the FDA this summer and it's most technologically advanced form, and we look forward to rolling it out next year.

我們的平台技術 Optejet 將於今年夏天向 FDA 提交，它是技術最先進的形式，我們期待明年推出。

And MicroPine, the potential blockbuster in the very underserved pediatric progressive myopia market is well positioned to be substantially derisked later this year.

MicroPine 是服務非常匱乏的兒童漸進性近視市場的潛在重磅產品，預計今年稍後將大幅降低風險。

I encourage everyone to keep up to date with our progress on eyenovia.com or through our social media links.

我鼓勵每個人在 eyenovia.com 或透過我們的社交媒體連結了解我們的最新進展。

This concludes our call and we look forward to talking with you again in August.

我們的通話到此結束，我們期待在八月再次與您交談。

Thank you.

謝謝。

Ladies and gentlemen, this concludes today's conference call.

女士們、先生們，今天的電話會議到此結束。

Thank you for your participation.

感謝您的參與。

You may now disconnect.

您現在可以斷開連線。