Eyenovia Inc (EYEN) 2023 Q4 法說會逐字稿

Greetings, and welcome to the Eyenovia Fourth Quarter and Full Year 2023 earnings call.

您好，歡迎參加 Eyenovia 第四季和 2023 年全年財報電話會議。

At this time, all participants are in a listen only mode.

此時，所有參與者都處於只聽模式。

A brief question and answer session will follow the formal presentation.

正式演講後將舉行簡短的問答環節。

If anyone should require operator assistance during the conference, please press star zero on your telephone keypad.

如果有人在會議期間需要接線員協助，請按下電話鍵盤上的星號零。

And as a reminder, this conference is being recorded and a pleasure to introduce your host, Eric Ribner of Investor Relations.

提醒一下，本次會議正在錄製中，很高興向您介紹主持人，投資者關係部的 Eric Ribner。

Thank you.

謝謝。

You may begin.

你可以開始了。

Good afternoon and welcome to Eyenovia's Fourth Quarter and Full Year 2023 earnings conference call and audio webcast.

下午好，歡迎來到 Eyenovia 的 2023 年第四季和全年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 Finance and 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 3 and 12 months ended December 31, 2023.

今天下午，我們發布了新聞稿，宣布截至 2023 年 12 月 31 日的 3 個月和 12 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 K for the year ended December 31st, 2023, which was filed with the SEC.

我們鼓勵大家閱讀今天的新聞稿以及 Eyenovia 向 SEC 提交的截至 2023 年 12 月 31 日的年度 10 K 表格季度報告。

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

該公司的新聞稿和年度報告也可在我們的網站 www.eyenovia.com 上取得。此外，本次電話會議正在透過公司網站進行網路直播，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 provisions 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, Adobe's management will be making forward-looking statements.

我們提醒聽眾，在電話會議期間，Adobe 管理層將做出前瞻性聲明。

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.

由於與公司業務相關的風險和不確定性，實際結果可能與這些前瞻性陳述中明示或暗示的結果有重大差異。

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.

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

This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, March 18th, 2024.

本次電話會議包含時效性訊息，僅截至本次直播之日（2024 年 3 月 18 日）準確。

Inovio 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.

Inovio 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, Michael, the floor is yours, Eric, and welcome, everyone, to our Fourth Quarter and Full Year 2020 Financial Results Conference Call.

話雖如此，我想將電話轉給 Eyenovia 執行長 Michael Rowe，Michael，請發言，Eric，歡迎大家參加我們的 2020 年第四季和全年財務業績電話會議。

Last quarter, I talked about how a spring ever was before as we continue our growth into a development and commercial organization.

上個季度，我談到了我們繼續成長為開發和商業組織時的春天是怎麼樣的。

Those levers were REVENUES agreements and sources of capital.

這些槓桿是收入協議和資本來源。

Today, I will share with you how we have been executing against these three levers, particularly in terms of our advancing commercial strategy, which continues to accelerate with two approved products and two in Phase three.

今天，我將與您分享我們如何針對這三個槓桿執行任務，特別是在我們推進商業策略方面，該策略繼續加速，有兩種產品獲得批准，另外兩種產品處於第三階段。

I will also share news about us entry into two significant agreements that will complement our own sales efforts as well as provide an update on our plans for dry eye.

我還將分享有關我們簽訂兩項重要協議的消息，這些協議將補充我們自己的銷售工作，並提供我們乾眼計劃的最新資訊。

Bren will then take us through the build-out of our manufacturing capabilities, which are now fully integrated and producing commercial supply of mid Kambi.

然後，布倫將帶我們了解我們的製造能力的建設，這些能力現在已經完全整合並生產中卡姆比的商業供應。

And finally, John will provide an update on the third lever, our financials and the options we are exploring towards ultimately ultimately reaching a breakeven point for the Company.

最後，約翰將提供有關第三個槓桿、我們的財務狀況以及我們正在探索的選項的最新信息，以最終使公司達到收支平衡點。

So let's dive right into it with our two FDA approved products of that, it's all proprietary ophthalmic suspension, 0.05% and mid Kambi.

因此，讓我們直接深入了解我們的兩種 FDA 批准的產品，它們都是專有的眼用懸浮液，0.05% 和中 Kambi。

As you may recall, the U.S. commercial rights for clobetasol were acquired from Taiwan based for most of pharmaceuticals last August.

您可能還記得，去年八月，大部分藥品的氯倍他索美國商業權是從台灣取得的。

Just last week, we transferred the NDA for it, but that is all from Formosa over to Eyenovia.

就在上週，我們將 NDA 轉移到了 Eyenovia，但這一切都從 Formosa 轉移到了 Eyenovia。

Well, that is all was approved just two weeks ago on March fourth, this unique post ocular surgery steroid is the first product developed using for most is proprietary APNT. nanoparticle formulation platform.

好吧，這就是兩週前的 3 月 4 日獲得批准的全部內容，這種獨特的眼科手術後類固醇是第一個使用大多數專有 APNT 開發的產品。奈米顆粒製劑平台。

That technology reduces an active pharmaceutical ingredients particle size with high uniformity and purity, thereby allowing penetration to relevant compartments in the eye and ultimately enhancing bioavailability.

此技術以高均勻度和純度降低活性藥物成分的粒徑，從而使其滲透到眼睛的相關區室，最終提高生物利用度。

Clobetasol is a potent steroid indicated for pain and inflammation following ocular surgery.

氯倍他索是一種有效的類固醇，適用於治療眼科手術後的疼痛和發炎。

This is the first time that this molecule is available in ophthalmology.

這是該分子首次用於眼科。

Its efficacy and safety profile is highly desirable with nearly nine out of 10 patients achieving complete absence of postsurgical pain and six out of 10 achieving total absence of inflammation within 15 days post ocular surgery.

其功效和安全性非常理想，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，十分之六的患者實現了完全消除發炎。

Well, that is all has an advantageous dosing price profile of twice-a-day without titration versus existing treatments, which require dosing up to four times a day.

嗯，與現有的治療方法相比，這一切都具有有利的給藥價格，每天兩次，無需滴定，而現有治療需要每天給藥四次。

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 doctors and patients alike.

因此，任何簡化治療方案的進步都會受到醫生和患者的歡迎。

And in terms of safety side effects were seen and no more than 2% of patients.

而且就安全性而言，出現副作用的患者不超過 2%。

And our label mentions that some of these side effects could have been the result of the surgical procedure itself.

我們的標籤提到其中一些副作用可能是外科手術本身造成的。

You can find additional information and full prescribing information at clobetasol b. i. d.com. It is estimated there are more than 7 million ocular surgeries in the U.S. each year, most which are treated with topical ocular steroids in steroid combinations currently totaling $1.3 billion in sales.

您可以在氯倍他索 b 上找到更多資訊和完整處方資訊。我。 d.com。據估計，美國每年有超過 700 萬例眼科手術，其中大多數使用類固醇組合中的局部眼部類固醇進行治療，目前銷售額總計 13 億美元。

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

這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佔據中個位數的市場份額。

We view clobetasol as a key addition to our commercial product growth portfolio, which will allow us to further leverage our existing sales force together with Kambi, our mydriasis product.

我們將氯倍他索視為我們商業產品成長組合的重要補充，這將使我們能夠進一步利用我們現有的銷售隊伍以及我們的散瞳產品 Kambi。

We believe that we can bring significant value to eyecare offices and surgical centers, and we are working toward the robust commercial launch of clobetasol as soon as our partner has received or Taiwanese export license later this year.

我們相信，我們可以為眼科診所和手術中心帶來巨大的價值，一旦我們的合作夥伴在今年稍後獲得台灣出口許可證，我們將致力於氯倍他索的商業推出。

Longer term, we see a potential opportunity to develop a formulation of clobetasol for our Optejet dispenser as a potential treatment for dry eye, a market estimated to be worth over $3.6 billion for that.

從長遠來看，我們看到了為 Optejet 分配器開發氯倍他索配方作為乾眼症潛在治療方法的潛在機會，該市場估計價值超過 36 億美元。

And we plan to engage with the FDA in the coming months to discuss a path forward in that indication.

我們計劃在未來幾個月與 FDA 合作，討論該適應症的前進道路。

While that is always a great product for us, it is only half of our revenue story.

雖然這對我們來說始終是一個很棒的產品，但這只是我們收入故事的一半。

Mid Kandi is the other half.

中康迪是另一半。

As you know, mid Colombia is the first and only FDA approved fixed combination of two pupil dilation drugs for Pecem I and phenylephrine.

如您所知，中哥倫比亞是第一個也是唯一一個FDA批准的Pecem I和去氧腎上腺素兩種擴瞳藥物的固定組合。

And the first one found like spray using the Optejet platform.

第一個發現就像使用 Optejet 平台進行噴霧一樣。

When our sales force talks with customers, they highlight how our products can help book endosurgery by using Maconomy s or mid patriotic agent, pre-surgery and clobetasol as their steroid post-surgery.

當我們的銷售人員與客戶交談時，他們強調我們的產品如何透過使用 Maconomy 或中愛國劑、術前藥物和氯倍他索作為術後類固醇來幫助預訂內視鏡手術。

We have now hired trained and deployed half of our 10 person field sales force with the remainder set to come on board in the coming weeks.

目前，我們已聘用並部署了 10 名現場銷售人員中的一半，並進行了培訓，其餘人員將在未來幾週內加入。

Also, we continue to make excellent progress satisfying state commercial licensing requirements, where required with Maconomy now licensed for sale in 16 states representing more than half of the US targeted population.

此外，我們在滿足各州商業許可要求方面繼續取得出色進展，Maconomy 現已獲得在代表美國一半以上目標人口的 16 個州銷售的許可。

We have a dozen other license applications in process in terms of manufacturing.

我們還有十幾個製造方面的其他許可證申請正在處理中。

In November, we were very pleased to announce that our contract manufacturer coastline International was approved by the FDA for mid Kabi commercial manufacturing.

11 月，我們非常高興地宣布，我們的合約製造商 Coastline International 已獲得 FDA 批准進行中期卡比商業生產。

We also recently announced FDA approval of our Redwood City facility as a commercial manufacturing facility with Redwood City, Reno and coastline.

我們最近也宣布 FDA 批准我們的雷德伍德城工廠作為雷德伍德城、裡諾和海岸線的商業製造工廠。

Now all online we have commenced the manufacture of commercial supply of the company, and we now have finished product moving into and out of our warehouse Brian will provide a more detailed manufacturing update in a moment.

現在，我們已經開始在線生產公司的商業供應，現在我們已經將成品移入和移出我們的倉庫，布萊恩將立即提供更詳細的製造更新。

Customer feedback on mid Kambi has been excellent.

客戶對中期 Kambi 的回饋非常好。

And to further illustrate that point, we are very pleased to announce that Vision Source, a leading network of approximately 3,000 locally owned optometry offices has added been Kambi as an approved product for its membership.

為了進一步說明這一點，我們非常高興地宣布 Vision Source（由約 3,000 家本地驗光辦公室組成的領先網路）已被 Kambi 添加為其會員認可的產品。

We have great expectations for the sales channel has been Kambi has particular benefits for those offices that are patient focused and choose to incorporate with Kambi to enhance the comprehensive eye exam experience of their patients.

我們對銷售管道抱有很大的期望，因為 Kambi 對那些以患者為中心並選擇與 Kambi 合作以增強患者綜合眼科檢查體驗的診所有特別的好處。

As we like to say these offices and doctors use mid Kambi because they care for their patients.

正如我們想說的那樣，這些辦公室和醫生使用中卡姆比是因為他們照顧病人。

The current U.S. market for pupil dilation is valued at approximately $250 million and we feel we are well poised to take a good portion of that market share over the coming years, especially when we move to our next generation device.

目前美國瞳孔擴張市場價值約為 2.5 億美元，我們認為我們已經準備好在未來幾年佔據該市場份額的很大一部分，特別是當我們轉向下一代設備時。

Staying on the topic of the company for a moment.

暫時停留在公司的話題。

We recently completed a study to determine if there was a lower dose that could be effective to achieve pupil dilation for drug sensitive patients.

我們最近完成了一項研究，以確定是否有較低的劑量可以有效地實現藥物敏感患者的瞳孔擴張。

The study was conducted by Dr. Davies pencil of the State University of New York School of Optometry. 29 subjects were treated with a half dose of economy, which is eight microliters per eye in that study at 30 minutes post-dose clinically relevant pupil dilation was achieved in approximately two thirds of patients, and that percentage increased by 60 minutes.

這項研究是由紐約州立大學視光學院的戴維斯鉛筆博士進行的。 29 名受試者接受了一半劑量的經濟治療，即每隻眼睛8 微升，在該研究中，給藥後30 分鐘，大約三分之二的患者實現了臨床相關的瞳孔擴張，並且該百分比增加了60 分鐘。

Almost all patients return to a pupil size of less than five millimeters between three and a half hours, six hours post installation.

幾乎所有患者在安裝後三個半小時、六個小時內瞳孔大小都會恢復到小於五毫米。

This is similar to the time seen in published studies of patients exposed to TripIt combined eyedrops and a mydriasis reversal drug.

這與已發表的研究中所見的時間相似，該研究涉及患者接觸 TripIt 聯合眼藥水和散瞳逆轉藥物。

The dose was well tolerated with minimal adverse events reported with three subjects reporting mild instillation site pain and one with mild dry eye upon installation.

此劑量耐受性良好，不良事件極少，三名受試者報告滴注部位有輕微疼痛，一名受試者在安裝後出現輕度乾眼症。

Given that a standard of care mydriasis agent seen, Elektrim may present safety risks in a few older patients, greater dosing flexibility enabled by mid Cami and the Optejet could address an unmet need among the approximately 100 billion comprehensive and diabetic eye exams and over 4 million cataract surgeries performed in the U.S. each year.

鑑於所見的標準治療散瞳劑，Elektrim 可能會對一些老年患者帶來安全風險，Mid Cami 和Optejet 實現的更大劑量靈活性可以解決約1000 億次綜合性糖尿病眼科檢查和超過400 萬人次中未滿足的需求美國每年都會進行白內障手術。

We plan to publish the full results in a peer reviewed journal later this year.

我們計劃今年稍晚在同行評審期刊上發表完整的結果。

As previously mentioned, we will soon have 10 sales representatives and two sales directors in the field to commercialize with Kambi and clobetasol.

如前所述，我們很快將在該領域擁有 10 名銷售代表和兩名銷售總監，以將 Kambi 和氯倍他索商業化。

Half of this team is already trained and in place working every day to present the benefits our products and portal revenue lever.

團隊的一半成員已經接受過培訓，每天都在現場工作，展示我們的產品和門戶收入槓桿的優勢。

Additionally, we recently announced a co-promotion agreement with NovaBay, a leading developer of anti-infective.

此外，我們最近宣布與領先的抗感染開發商 NovaBay 達成聯合推廣協議。

I products for the per the terms of that agreement, NovaBay will promote clobetasol to hundreds of eye care professionals that our salespeople are not calling on.

根據該協議的條款，NovaBay 將向數百名眼科護理專業人士推銷氯倍他索，而我們的銷售人員並未邀請這些專業人士。

So it's telephone based sales people.

所以這是基於電話的銷售人員。

They will also conduct outreach to doctors in those geographic areas that our salespeople are not currently covering.

他們還將向我們的銷售人員目前未涵蓋的地理區域的醫生進行外展活動。

Meanwhile, our field sales force will promote their prescription Epanova, 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，我們的現場銷售人員將向我們的醫生推銷他們的處方 Epanova、抗菌眼瞼和睫毛解決方案，醫生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 additional promotion and potential sales for both sides.

除了為雙方帶來額外促銷和潛在銷售的好處之外。

Each party will also get a percentage of the sales that they generate.

各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。

In summary, we are actively promoting that Kambi and we'll be leveraging our new agreement with Vision Source.

總之，我們正在積極推廣 Kambi，並且我們將利用與 Vision Source 的新協議。

We are preparing to commercialize clobetasol, and we'll leverage our new agreement with NovaBay, and we are reloading our pipeline by bringing MicroPine back through reacquiring the commercial and development rights this past January for the US and Canada from Bausch & Lomb micro MicroPine is an investigational eight microliter ophthalmic spray of atrophy being delivered by the Optejet.

我們正在準備將氯倍他索商業化，我們將利用與NovaBay 的新協議，並透過今年1 月從Bausch & Lomb 重新獲得MicroPine 在美國和加拿大的商業和開發權，重新加載我們的產品線。Pine是Optejet 提供一種研究性的 8 微升萎縮眼用噴霧劑。

Micropine is being evaluated as a potential treatment for pediatric progressive myopia for worsening near site, which is characterized by elongation of the sclera and retina.

Micropine 正在被評估為治療兒童進行性近視惡化的潛在治療方法，其特徵是鞏膜和視網膜伸長。

We estimate that more than 25 million children in the U.S. suffer from myopia and of these 5 million are believed to be at high risk for progressive myopia.

我們估計，美國有超過 2,500 萬名兒童患有近視，其中 500 萬人被認為是進行性近視的高風險族群。

If left untreated, progressive myopia can ultimately lead to significant vision loss and potential blindness.

如果不及時治療，進行性近視最終會導致嚴重的視力喪失和潛在的失明。

Prior studies have demonstrated that atrophy and can slow myopia progression by as much as 60%.

先前的研究表明，萎縮可以減緩近視進展達 60%。

And there is a significant unmet need for safe and effective FDA-approved pharmaceutical treatment options.

對於 FDA 批准的安全有效的藥物治療方案，存在著巨大的未滿足的需求。

In terms of next steps, we are continuing to advance to Phase three CHAPERONE study, and we plan to meet with the FDA to explore options to expedite development and registration of MicroPine in a capital-efficient manner.

就下一步而言，我們將繼續推進第三階段 CHAPERONE 研究，並計劃與 FDA 會面，探討以資本高效的方式加快 MicroPine 開發和註冊的方案。

One option.

一種選擇。

We are working on a planned interim look at the CHAPERONE data later this year.

我們正在計劃在今年稍後對 CHAPERONE 數據進行中期檢查。

If that interim analysis is successful, we could potentially be looking at a substantially de-risked program that could be very attractive either for us alone or for a commercialization partner.

如果中期分析成功，我們可能會尋找一個大幅降低風險的計劃，無論對我們還是對商業化合作夥伴都非常有吸引力。

Lastly, we are maintaining MicroLine or aperture in our portfolio should the presbyopia market shows signs of improvement right now.

最後，如果老花眼市場目前顯示出改善的跡象，我們將在我們的投資組合中維持 MicroLine 或光圈。

Our opinion is that we can make better use of our capital elsewhere in our portfolio.

我們的觀點是，我們可以在投資組合的其他地方更好地利用我們的資本。

So we can turn very quickly back to this product candidate if the situation should change.

因此，如果情況發生變化，我們可以很快轉向該候選產品。

So this gives us line of sight to three and possibly four commercial revenue-generating products.

因此，這使我們能夠看到三種甚至四種商業創收產品。

We continue to explore development of novel therapeutics, leveraging the Optejet for dry eye glaucoma and other large market indications as part of our second lever towards success.

我們繼續探索新型療法的開發，利用 Optejet 治療乾眼青光眼和其他大型市場適應症，作為我們邁向成功的第二個槓桿的一部分。

These potential partnerships are moving forward and we anticipate sharing more information when they reach the stage of a full development agreements after all of the device compatibility work has been completed.

這些潛在的合作夥伴關係正在向前發展，我們預計在所有設備相容性工作完成後，當他們達到全面開發協議的階段時，我們將分享更多資訊。

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

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

Bren?

布倫？

Thank you, Michael.

謝謝你，麥可。

During the fourth quarter and through early this year, we continue to execute on our strategy to maintain control of our manufacturing processes, ensuring our products with high levels of reliability and sterility.

從第四季度到今年年初，我們繼續執行我們的策略，以保持對製造流程的控制，確保我們的產品具有高水準的可靠性和無菌性。

As a reminder, we use contract manufacturers to supply us with drug substance, which we then used to fill our cartridges at our Redwood City facility.

提醒一下，我們使用合約製造商向我們提供原料藥，然後我們用這些原料在我們的雷德伍德城工廠填充我們的墨盒。

These cartridges are then married with our electronic base units, which are manufactured at our Reno, Nevada facility.

然後，這些墨盒與我們的電子基礎單元結合在一起，這些單元是在我們內華達州里諾工廠製造的。

We are now fully capable of supporting our current anticipated mid Kabi commercial demand as well as the needs for ongoing MicroPine development in 2024.

我們現在完全有能力支持當前預期的 Kabi 中期商業需求以及 2024 年正在進行的 MicroPine 開發的需求。

More specifically, last month, we were very pleased to receive FDA approval of our Redwood City facility with no significant concerns raised on the part of the agency.

更具體地說，上個月，我們非常高興獲得 FDA 對我們雷德伍德城工廠的批准，該機構沒有提出任何重大擔憂。

This approval will provide Redwood City with the ability to perform final assembly packaging and labeling activities in support of Maconomy and complements our Reno facilities and contract manufacturers.

此次批准將使紅木城能夠執行最終組裝包裝和標籤活動，以支持 Maconomy 並補充我們的里諾工廠和合約製造商。

As previously announced, coastline International also received FDA approval and is now producing mid Tommy commercial supply Redwood City will also be the manufacturing site of our Gen two device, which has significantly fewer parts than our existing device, making its manufacturing easier and more reliable.

正如先前宣布的那樣，海岸線國際公司也獲得了FDA 的批准，現在正在生產中型Tommy 商業供應。紅木城也將成為我們第二代設備的製造基地，該設備的零件數量比我們現有的設備少得多，使其製造更容易、更可靠。

We are targeting the economy as the first product that will be available in Gen two.

我們的目標是將經濟作為第二代中推出的第一個產品。

And our Redwood City facility is actually making product to begin engineering stability studies and registration batches before the end of the year.

我們的雷德伍德城工廠實際上正在生產產品，以便在年底前開始工程穩定性研究和註冊批次。

Our strategy for moving from the Gen one to Gen two will be the subject of an FDA meeting this summer.

我們從第一代轉向第二代的策略將成為今年夏天 FDA 會議的主題。

And assuming we come to an agreement demonstrating comparability between the two devices should provide a path for Eyenovia to introduce the Gen two platform into the commercial market.

假設我們達成協議，證明兩種設備之間的可比性，應該為 Eyenovia 將第二代平台引入商業市場提供一條途徑。

Our Reno facility is also producing the Artesia injector and base in support of Maconomy and continue to expand production capabilities by refining our state-of-the-art equipment.

我們的里諾工廠還生產 Artesia 注射器和底座，以支援 Maconomy，並透過改進我們最先進的設備繼續擴大生產能力。

When complete the capabilities of this new facility will provide significant increase in injector manufacturing capacity enabling fulfillment of both our commercial and clinical product needs.

竣工後，該新工廠的能力將顯著提高注射器的製造能力，從而滿足我們的商業和臨床產品需求。

As noted earlier this year, I know via has reacquired the rights to MicroPine.

正如今年早些時候所指出的，我知道 via 已經重新獲得了 MicroPine 的權利。

Micropine is an investigational eight microliters of foam Express atrophy delivered by Eyenovia's proprietary Optejet device being evaluated as a potential treatment for pediatric progressive myopia characterized by elongation of the retina.

Micropine 是一種研究性的 8 微升快速萎縮泡沫，由 Eyenovia 專有的 Optejet 設備輸送，被評估為治療以視網膜伸長為特徵的兒童進行性近視的潛在治療方法。

We are actively uplifting our MicroPine clinical management capabilities in this regard, which we expect to be complete in mid April of this year, with MicroPine under our management.

我們正在積極提升MicroPine在這方面的臨床管理能力，預計今年4月中旬完成，由我們管理MicroPine。

Eyenovia will be speaking with the FDA to discuss opportunities to accelerate the completion of the study.

Eyenovia 將與 FDA 討論加速完成研究的機會。

I continue to be excited about our recent successes and the progress we are making.

我仍然對我們最近的成功和正在取得的進展感到興奮。

We now have two FDA approved manufacturing sites that we manage for turning us to meet the market demands for our products.

我們現在擁有兩個 FDA 批准的生產基地，我們管理這些生產基地，使我們能夠滿足市場對我們產品的需求。

I'm looking forward to expanding on the significant achievements to be made in this year.

我期待著擴大今年取得的重大成就。

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

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

John?

約翰？

Thank you, Brent.

謝謝你，布倫特。

For the fourth quarter of 2023, we reported net loss of approximately $8 million or $0.18 per share and approximately $45.4 million weighted average shares outstanding.

2023 年第四季度，我們報告的淨虧損約為 800 萬美元，即每股 0.18 美元，加權平均已發行股票約為 4,540 萬美元。

This includes a $0.02 loss related to the one-time repeat repatriation costs we're bringing a microphone back to I know via from best.

這包括與一次性重複遣返費用相關的 0.02 美元損失，我們將麥克風帶回「我知道」。

This compares to a net loss of $6.1 million or $0.17 per share and approximately$ 35.9 million weighted average shares outstanding for the fourth quarter of 2022.

相比之下，2022 年第四季的淨虧損為 610 萬美元或每股 0.17 美元，加權平均已發行股票約為 3,590 萬美元。

For the full year 2023, we reported a net loss of approximately $27.3 million or $0.66 per share and approximately $41 million weighted average shares outstanding.

2023 年全年，我們報告的淨虧損約為 2,730 萬美元，即每股 0.66 美元，加權平均已發行股票約為 4,100 萬美元。

This compares to $28 million or $0.83 per share and approximately $33.6 million weighted average shares outstanding for the full year 2022.

相比之下，2022 年全年流通股加權平均金額約為 3,360 萬美元，即每股 2,800 萬美元或 0.83 美元。

Research and development expenses totaled approximately $4.1 million for the fourth quarter of 2023 and this compares to $2.2 million for the fourth quarter of 2022, an increase of 84.6% for the full year 2023 research and development expenses decreased approximately 3% to $13 million, and this compares to $13.4 million for the full year 2022.

2023 年第四季的研發費用總計約為410 萬美元，而2022 年第四季的研發費用為220 萬美元，成長了84.6%，2023 年全年研發費用下降了約3%，至1,300 萬美元，相較之下，2022 年全年為 1,340 萬美元。

Full year decrease was driven primarily by lower direct clinical and nonclinical expenses as well as deferral of costs related to the future delivery of clinical supply to our license partners.

全年下降主要是由於直接臨床和非臨床費用的減少以及與未來向我們的許可合作夥伴交付臨床供應相關的成本的遞延。

For the fourth quarter of 2023 general and administrative expenses were approximately $3.4 million as compared to $3.2 million for the fourth quarter of 2022, an increase of 7.3%.

2023 年第四季的一般及管理費用約為 340 萬美元，而 2022 年第四季為 320 萬美元，成長 7.3%。

For the full year 2023, G&A expenses decreased approximately 8.1% to $12.4 million as compared to $13.5 million for the full year 2022.

2023 年全年，一般及行政費用下降約 8.1%，至 1,240 萬美元，而 2022 年全年為 1,350 萬美元。

Full year decrease was driven by reduction in legal expenses and executive recruitment costs on a year-over-year basis.

全年下降的原因是法律費用和高階主管招募成本年減。

Total operating expenses for the fourth quarter of 2023 were approximately $7.5 million as compared to $5.4 million for the same period in 2022.

2023 年第四季的總營運費用約為 750 萬美元，而 2022 年同期為 540 萬美元。

This represents an increase of approximately 39% total operating expenses for the full year 2023 decreased approximately 5.6%, $25.4 million as compared to $26.9 million for the full year 2022.

這意味著 2023 年全年的總營運支出增加了約 39%，與 2022 年全年的 2,690 萬美元相比，減少了約 5.6%，即 2,540 萬美元。

As of December 31st, 2023, company's cash balance was approximately $14.8 million as compared to $22.9 million as of December 31st, 2022.

截至 2023 年 12 月 31 日，公司現金餘額約為 1,480 萬美元，而截至 2022 年 12 月 31 日為 2,290 萬美元。

We are currently reviewing evaluating various structures and alternatives to increase our cash resources in order to fund our corporate strategy going forward.

我們目前正在審查評估各種結構和替代方案，以增加我們的現金資源，以便為我們未來的企業策略提供資金。

I'll now provide an update on our existing licensing agreement with Arctic Vision for all three of our products in China and South Korea.

現在，我將提供我們與 Arctic Vision 就我們在中國和韓國的所有三種產品簽訂的現有授權協議的最新情況。

Regarding our prior partnership with Bausch & Lomb as Michael mentioned earlier, we reacquired the development and commercial rights to Micrus being now taken over continued execution of the ongoing Phase three CHAPERONE trial.

關於我們之前與 Bausch & Lomb 的合作關係，正如 Michael 之前提到的，我們重新獲得了 Micrus 的開發和商業權利，現在正在接管繼續執行正在進行的第三階段 CHAPERONE 試驗。

Our agreement with Arctic Vision covers MicroPine MicroLine and mid Kambi and provides us sales royalties in addition to development milestones.

我們與 Arctic Vision 的協議涵蓋 MicroPine MicroLine 和 mid Kambi，除了開發里程碑之外，我們還向我們提供銷售特許權使用費。

Micropatent in particular is a significant opportunity in China for pediatric myopia.

尤其是微專利對於中國兒童近視來說是一個重大機會。

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。

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

資料授權協議已產生約 1,600 萬美元的授權費，並且我們有潛力在未來三到四年內從 Arctic Vision 獲得額外 2,500 萬美元的淨許可和開發里程碑。

If our products are approved on commercialization, Eyenovia is also eligible to earn significant sales royalties as well.

如果我們的產品獲得商業化批准，Eyenovia 也有資格獲得可觀的銷售特許權使用費。

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

我們正在繼續評估潛在的管道擴張機會，類似於我們的 Formosa 協議，我們將繼續利用 Optejet 技術來解決未滿足的需求，從乾眼開始到結束的其他大型眼科適應症。

We are very pleased with our performance in the fourth quarter of 2023 as well as a subsequent period to summarize our key highlights today, we reacquired the development and commercialization rights to MicroPine in the US and Canada from Bausch & Lomb.

我們對 2023 年第四季以及隨後一段時間的表現非常滿意，今天總結我們的主要亮點，我們從博士倫手中重新獲得了 MicroPine 在美國和加拿大的開發和商業化權利。

Micropine as a phase is in Phase three as a potential treatment for progressive pediatric myopia, a potential blockbuster opportunity for the company.

Micropine 作為一個階段處於第三階段，作為漸進性兒童近視的潛在治療方法，這對公司來說是一個潛在的重磅機會。

We announced FDA approval of clobetasol for the treatment of pain and inflammation following ocular surgery.

我們宣布 FDA 批准氯倍他索用於治療眼科手術後的疼痛和發炎。

We announced two important agreements to complement their own sales efforts, one with Vision Source permit, Kambi and one with NovaBay for clobetasol and Abba Nova.

我們宣布了兩項重要協議，以補充他們自己的銷售工作，其中一項獲得 Vision Source 許可，即 Kambi，另一項與 NovaBay 簽署氯倍他索和 Abba Nova。

We finalized the build-out of our manufacturing capabilities to support mid co-production with CoSine manufacturing and our Redwood City facility is now online in addition to our facility in Reno.

我們完成了製造能力的建設，以支持與 CoSine 製造的中期聯合生產，除了裡諾工廠外，我們的紅木城工廠現已上線。

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 and commercialization.

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銷售、特許權使用費和商業化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 now like to turn the call open the call over for questions.

我們現在想打開電話以詢問問題。

Operator?

操作員？

Thank you.

謝謝。

We will now be conducting a question and answer session.

我們現在將進行問答環節。

(Operator Instructions)

（操作員說明）

Tim Lugo, William Blair.

提姆·盧戈，威廉·布萊爾。

First for the questions.

首先是提問。

Why although Microtune has been top of the company and you have the rights.

為什麼雖然Microtune已經是公司的最高層並且你有權利。

Can you talk about this accelerating the development of the program?

您能談談這加速了程式的開發嗎？

I know in the remarks you mentioned you're engaged with the agency about this top seven, maybe I'd love to hear some initial thoughts around what you could do for this acceleration of the development.

我知道在您提到的評論中，您正在與該機構就這前七名進行合作，也許我很想聽聽一些關於您可以為加速開發做些什麼的初步想法。

Yes, Tim, thank you for the question.

是的，提姆，謝謝你的提問。

Our intent is to do a protocol amendment and put in an interim analysis later this year when we believe we have sufficient power to detect a significant significant results from one of the arms of this study and we'll be talking to the FDA about that as well because if we do that and if we are successful as a placebo-controlled study, we may be able to make the argument that it's really not ethical to continue as it is with a placebo arm.

我們的目的是在今年稍後進行方案修訂並進行中期分析，屆時我們相信我們有足夠的能力從這項研究的一個分支中檢測到顯著的結果，我們將與 FDA 討論這一問題好吧，因為如果我們這樣做，並且如果我們作為安慰劑對照研究取得成功，我們也許能夠提出這樣的論點：繼續使用安慰劑組確實是不道德的。

If we can show that we already have a significant event and that could shave a number of years off from off the study and enable us to bring it to an NDA that much faster.

如果我們能夠證明我們已經發生了一件重大事件，那麼研究的時間可能會縮短很多年，並使我們能夠更快地將其提交給 NDA。

So the strategy is to do the interim analysis towards the end of this year.

因此，策略是在今年年底前進行中期分析。

And if that is successful to talk to the FDA about how we can close that study earlier so that we can move to an NDA.

如果成功的話，我們可以與 FDA 討論如何儘早結束研究，以便我們可以進入 NDA。

That's very helpful.

這非常有幫助。

Thank you.

謝謝。

You're welcome.

不客氣。

Regarding the H2 study.

關於H2研究。

Is that something that you can adjust to or do you need to submit an NDA to get it onto the label?

您可以對此進行調整嗎？或者您是否需要提交 NDA 才能將其新增至標籤？

Well, to get that onto the label, we would have to submit to the FDA.

好吧，為了將其添加到標籤上，我們必須向 FDA 提交申請。

That study was done to answer a very specific medical question for specific populations.

這項研究是為了回答特定族群的一個非常具體的醫學問題。

So we are able to adjust to that with the Optejet because we didn't want to get that answer to see if you could go lower for this particular need.

因此，我們能夠透過 Optejet 進行調整，因為我們不想得到這個答案來看看您是否可以降低這一特定需求。

Okay, fair enough.

好吧，很公平。

And before the NovaBay co-promotion, could you again, maybe you have this in my comments and I missed it, but keeps Can you scope out what capabilities that are playing into the margin on clobetasol?

在 NovaBay 聯合促銷之前，您能否再一次，也許您在我的評論中提到了這一點，但我錯過了它，但您能看看氯倍他索的利潤率有哪些功能嗎？

They are bringing an in-house sales force that's very experienced doing telephone sales into cataract surgeons.

他們正在為白內障外科醫生引進一支在電話銷售方面經驗豐富的內部銷售團隊。

They do it now for their product have Inova.

他們現在這樣做是因為他們的產品有 Inova。

So they would take that experience and do the same for clobetasol in those areas where we do not have salespeople.

因此，他們會利用這項經驗，在我們沒有銷售人員的地區對氯倍他索做同樣的事情。

So essentially they will extend our reach into those offices.

因此，從本質上講，他們會將我們的影響力擴展到這些辦公室。

And every time they're successful, they will get a percentage percentage of that sale.

每次他們成功時，他們都會獲得銷售額的一定比例。

And likewise, we can hand carry their product ever Knova into cataract surgeons where we do have salespeople because it is part of many of their practices and where we are successful, we get a portion of that.

同樣，我們可以將他們的產品 Knova 親手帶到白內障外科醫生那裡，我們確實有銷售人員，因為這是他們許多實踐的一部分，並且在我們成功的地方，我們得到了其中的一部分。

So basically, it's a way to extend our promotional reach with no additional cost and the opportunity to pick up some money at the same time.

所以基本上，這是一種擴大我們的促銷範圍的方法，無需額外費用，同時還有機會賺到一些錢。

Understand, it make sense.

明白了，有道理。

Thank you.

謝謝。

Thank you.

謝謝。

Matt Kaplan, Ladenburg Thalmann.

馬特卡普蘭，拉登堡塔爾曼。

Hey, guys, good evening and thanks for taking the questions and congrats on the progress.

嘿，夥計們，晚上好，感謝您提出問題並祝賀取得的進展。

But just wanted to first focus on your commercial programs.

但只想先關注您的商業計劃。

Can you help us understand the kind of potential launch trajectories for both clobetasol and candy and what we should expect, I guess, this year and going into next specifically?

您能否幫助我們了解氯倍他索和糖果的潛在上市軌跡，以及我們今年和明年應該期待什麼？

Yes, hi, Matt.

是的，嗨，馬特。

It's good to have your call, John.

很高興接到你的電話，約翰。

I believe that there have been analysts out there that have spoken to this.

我相信已經有分析師談到這一點。

I know we haven't given guidance, but maybe you can talk to what our reaction has been to the analysts?

我知道我們還沒有給出指導，但也許你可以談談我們對分析師的反應是什麼？

Yes.

是的。

So we the analysts do have numbers in their model out there, and we're very comfortable with the with the analyst estimates that are out there for the balance of 2024.

因此，我們分析師的模型中確實有數據，而且我們對分析師對 2024 年剩餘時間的估計非常滿意。

At this point, we're not going to give revenue guidance ourselves.

目前，我們不會自己提供收入指導。

We'll reevaluate that at the end of the year after these products.

我們將在這些產品推出後的年底重新評估這一點。

Have, you know, been in the market for a while.

你知道，已經進入市場一段時間了。

But overall, I think we're comfortable with the analysts' estimates that are out there.

但總的來說，我認為我們對分析師的估計感到滿意。

Okay.

好的。

That's helpful.

這很有幫助。

And maybe just to focus in on a little bit with your new sign agreement with a Vision Source.

也許只是關注您與 Vision Source 簽署的新協議。

You mentioned that there are about 3,000 offices that are associated with that.

您提到大約有 3,000 個與之相關的辦事處。

Should we should we expect more additional deals or collaborations such as these kind of going forward as you continue to launch in the Mid-Con being called that as well?

當你們繼續在 Mid-Con 中推出這類產品時，我們是否應該期待更多額外的交易或合作？

Yes, absolutely.

是的，一點沒錯。

So this is the first one that signed.

所以這是第一個簽的。

We do have others that are in the signature phase, Tom, and they're a mix.

湯姆，我們確實還有其他處於簽名階段的人，他們是混合體。

Some of them are like Vision Source for us for the retail optometrist.

其中一些就像我們零售驗光師的 Vision Source 一樣。

Others are with large institutions and where they are looking to replace their disposable use of major navigation agents.

其他人則在大型機構工作，他們希望取代主要導航代理商的一次性使用。

What they do now is they use evolving one and they throw it away and it's costly to them it's like $15 every time they do this to a patient, so they would replace that would be Kambi.

他們現在所做的就是使用不斷進化的一種藥物，然後把它扔掉，這對他們來說代價高昂，每次對病人這樣做都會花費 15 美元，所以他們會用 Kambi 來代替。

And we are working right now to get some of these agreements signed where we would essentially be on their formulary, replacing what they're doing now.

我們現在正在努力簽署其中一些協議，我們基本上將在他們的處方中，取代他們現在正在做的事情。

And then just shifting to your pipeline, your second generation device, can you tell us a little bit more about that and how it how it differs from the first gen and when when we should expect it potentially to be used within the county in the marketplace?

然後轉向你的管道，你的第二代設備，你能告訴我們更多關於它的資訊嗎？它與第一代設備有何不同，以及我們何時應該期望它在市場上的縣內使用？

Yes, Brad, would you like to give a high level discussion about gen two?

是的，布拉德，您想對第二代進行高層討論嗎？

Absolutely.

絕對地。

So our Gen two product offers the symptom of simplification from a manufacturing capability, enabling us to produce these more easily with a high reliability with mid Kabi being the first platform that we're going to take that into.

因此，我們的第二代產品提供了製造能力簡化的症狀，使我們能夠更輕鬆地以高可靠性生產這些產品，而中卡比是我們要採用的第一個平台。

We're actually actively working on our registration batches to be completed this year.

實際上，我們正​​在積極致力於今年完成的註冊批次。

And then we'll be speaking with the FDA on getting the Gen two platform integrate Kambi, hopefully early next year after we did the registration batches of Quintum.

然後我們將與 FDA 討論讓第二代平台整合 Kambi，希望在明年初我們完成 Quintum 的註冊批次後。

Okay, great.

好的，太好了。

And then with respect to your dry eye program, can you tell us a little bit more about that and when we do expect to move that into the clinic this year?

關於您的乾眼項目，您能否告訴我們更多有關該項目的信息以及我們預計今年何時將其轉移到診所？

Yes.

是的。

We actually have some three things that we're working on.

我們實際上正在做三件事。

We have acute dry eye that we're in discussions with Formosa protocol.

我們患有急性乾眼症，正在與福爾摩沙協議進行討論。

That is all we have chronic dry eye that we're actually in actively collaborating with a company where we're working on taking their drug and putting it into the Optejet and making sure it's entirely compatible.

這就是我們患有慢性乾眼症的全部原因，我們實際上正在與一家公司積極合作，我們正在努力服用他們的藥物並將其放入 Optejet 中並確保其完全相容。

And then we have a third one that we're also would be in chronic a different molecule that we're working on.

然後我們還有第三個，我們也將長期處於我們正在研究的不同分子中。

So what we want to do is we have collaboration agreements in place and what's happening in that collaboration agreement is we're working out all of the CMC issues of how do we get your drug over to our facility in a serial fashion fashion?

所以我們想要做的是我們已經制定了合作協議，並且在該合作協議中我們正在解決所有 CMC 問題，即我們如何以連續方式將您的藥物轉移到我們的設施？

And how do we make sure it's compatible with our device.

我們如何確保它與我們的設備相容。

All of that takes anywhere between four and six months when that's done, that leads to an option for a development agreement.

所有這些都需要四到六個月的時間才能完成，從而產生開發協議的選擇。

And that's when we'll talk about it publicly.

那時我們將公開討論它。

Okay, great.

好的，太好了。

Thanks again for taking the questions.

再次感謝您提出問題。

Thank you, Mathew.

謝謝你，馬修。

Thank you.

謝謝。

Matthew Caulfield, HC.

馬修·考爾菲爾德，HC。

Wainwright.

溫賴特。

Hey, Michael and team, thanks for taking our question on.

嘿，邁克爾和團隊，感謝您回答我們的問題。

So with clobetasol plans for Optejet development and dry eye, are there any comparable advantages, so ultimately, utilizing Optejet within the approved indication for postoperative pain?

那麼，氯倍他索計畫用於 Optejet 開發和乾眼治療，是否有任何類似的優勢，因此最終在核准的術後疼痛適應症中使用 Optejet？

Thank you, Matthew, for that question.

謝謝馬修提出這個問題。

And the answer is yes, it would be a lot easier for cataract and other post-surgical patients who use the Optejet my opinion that an eyedropper and we could certainly go back and look at that.

答案是肯定的，對於白內障和其他使用 Optejet 的術後患者來說，這會容易得多，我認為滴管和我們當然可以回去看看。

Again, what we would have to do basically is run a pain study, although only one of the pain and inflammation because according to the FDA, the Optejet delivers an ophthalmic spray, which is a different form than a Sonic Solutions.

同樣，我們基本上要做的是進行疼痛研究，儘管只是疼痛和發炎之一，因為根據 FDA 的說法，Optejet 提供眼科噴霧劑，與 Sonic Solutions 的形式不同。

So it requires a Phase three study.

因此需要進行第三階段研究。

Why that's a good thing is that it makes it impossible to replace the Optejet with an eyedrop.

為什麼這是一件好事，因為它使得 Optejet 無法用眼藥水取代。

So from a generic point of view, you can't simply take a molecule we put into the Optejet, replace it with something that's in an eyedrop form.

因此，從一般的角度來看，你不能簡單地將我們放入 Optejet 中的分子，用滴眼劑形式的東西替換它。

So that's a good thing.

所以這是一件好事。

But on the other hand, it causes us a little bit more time to get something approved.

但另一方面，這讓我們有更多的時間來獲得批准。

So the strategy was let's get this additional indication for dry eye, which is a much bigger indication and for them for the product.

因此，我們的策略是讓我們獲得乾眼症的額外適應症，這對他們的產品來說是一個更大的適應症。

And then we can make the decision to pivot back and redo a pain and inflammation one study and to add that onto the Optejet and then ultimately just beyond the Optejet platform.

然後我們可以決定回頭重做一項疼痛和發炎研究，並將其添加到 Optejet 上，然後最終超出 Optejet 平台。

Understood very helpful.

了解了非常有幫助。

And then with the on the $14.8 million in cash and equivalents through year end '23, I don't know if I missed this, but did you give any sense of the current cash runway just for the near term,?

然後到 23 年底為止，我有 1480 萬美元的現金和等價物，我不知道我是否錯過了這一點，但您是否對當前短期內的現金跑道有任何了解？

John, would you like to take that?

約翰，你願意接受這個嗎？

Yes.

是的。

I'll take that.

我會接受的。

So as I mentioned in the prepared remarks that we're actually evaluating all different opportunities that we have and when they raise cash in order to fund the company's strategy going forward, the historical burn has been about $4.5 million to $5 million per quarter on an operating basis, we don't expect that to change at all.

因此，正如我在準備好的發言中提到的，我們實際上正在評估我們擁有的所有不同機會，當他們籌集現金以便為公司未來的策略提供資金時，歷史上每季的燒錢約為450萬至500 萬美元。營運基礎，我們預計這一點不會發生任何改變。

We will see some decrease in R&D expenses, some increase associated with the MicroPine study.

我們將看到研發費用有所減少，但與 MicroPine 研究相關的費用有所增加。

So that's basically where we think the operating burn will come in for the year.

因此，這基本上就是我們認為今年營運消耗的情況。

We are expecting close to $2 million from Arctic Vision as well for a product development milestone going forward.

我們預計 Arctic Vision 還將提供近 200 萬美元的資金，以實現未來產品開發的里程碑。

So that gives you somewhat of a sense of where we see us from a cash standpoint.

因此，這讓您對我們從現金角度看待我們的情況有所了解。

That's great.

那太棒了。

Very helpful.

很有幫助。

I appreciate it guys, and congrats on the transition to a commercialized company.

我很感激你們，並祝賀你們向商業化公司的轉變。

Thank you, Matthew.

謝謝你，馬修。

Appreciate that.

感謝。

Thanks, Matt.

謝謝，馬特。

Thank you.

謝謝。

Kemp Dolliver, Brookline Capital Markets.

Kemp Dolliver，布魯克林資本市場。

So I have two questions.

所以我有兩個問題。

First, with regard to our pursuit or what needs to change for you to started advancing that program again?

首先，關於我們的追求或說你們需要改變什麼才能重新開始推進這個計畫？

Thank you.

謝謝。

It's good to have you on the call and the good question.

很高興接到您的電話並提出了一個好問題。

So right now that market is pretty stable, and beauty is selling about $14 million or $15 million, maybe not even that high per year.

所以現在市場相當穩定，美容產品的銷售額約為 1400 萬或 1500 萬美元，甚至可能每年都沒有那麼高。

So to be successful in this market is going to require, in my opinion, a strong promotional effort to basically do a relaunch of this.

因此，在我看來，要想在這個市場取得成功，就需要強而有力的促銷努力，基本上就是重新啟動這個市場。

So if I look at it, if we do it, it's $1 million to do the registration batches.

所以如果我看一下，如果我們這樣做的話，註冊批次的費用是 100 萬美元。

It's $4 million to file the NDA.

提交 NDA 的費用為 400 萬美元。

So that's five.

所以這是五個。

And that's without making the investments tried to lift the market.

這還是在沒有進行試圖提振市場的投資的情況下。

And that's pretty pricey in the market right now that's doing less than $15 million.

目前該產品在市場上的價格相當昂貴，其售價不到 1,500 萬美元。

So there is already one approved product that's waiting on the sidelines and eyedrop to come in.

因此，已經有一種獲得批准的產品正在等待上市，眼藥水也正在等待上市。

There's another one that's in Phase three.

還有一個處於第三階段。

I think at the end, there may be multiple eyedrop competitors in the market, but we would be the only Optejet.

我認為最終，市場上可能會有多個眼藥水競爭對手，但我們將是唯一的 Optejet。

So if one or two of them come in and they're able to resurrect this market.

因此，如果他們中的一兩個進來，他們就能夠復興這個市場。

We are entirely comfortable with letting someone else do that and coming in with what we perceive as a better product, better for patients and better for the doctors as well and coming in after they do that heavy lifting.

我們完全樂意讓別人來做這件事，並推出我們認為更好的產品，對患者更好，對醫生也更好，並在他們完成繁重的工作後進來。

So we'll be happy to take our money and use it elsewhere.

因此，我們很樂意將我們的錢用於其他地方。

And then wait and no that we can pivot to this at any time.

然後等待，不，我們可以隨時轉向這一點。

Is this something you would partner out possibly?

您可能會合作嗎？

We would and we certainly could be talking with people, but I don't think at the moment, there's a tremendous amount of interest in the market.

我們會而且我們當然可以與人們交談，但我認為目前市場上並沒有很大的興趣。

So again, I think there's a lot of the big players are waiting by the side to see what happens as well.

再說一次，我認為有很多大公司也在旁邊等著看會發生什麼事。

Great.

偉大的。

Thank you.

謝謝。

And my second question is was on clobetasol and with your market share guidance, just to take the other side of the thought process.

我的第二個問題是關於氯倍他索和您的市場份額指導，只是為了思考過程的另一面。

So you have a product with superior dosing.

這樣您就擁有了劑量優越的產品。

What's the gating factor with the update given that or the uptake given that advantage?

考慮到這一點，更新的限制因素是什麼？或者考慮到這一優勢，吸收率的限制因素是什麼？

So if you look at the glaucoma market as a surrogate because it's very similar.

因此，如果您將青光眼市場視為替代品，因為它非常相似。

You basically have 80% or 85% of the units are actually sold are generics.

基本上，實際銷售的產品中 80% 或 85% 都是仿製藥。

And then you have a small group of branded products that make up 15% of the units, but they make up about 50% of the value.

還有一小部分品牌產品，佔單位數量的 15%，但約佔價值的 50%。

So it would be very similar in the steroid market.

所以類固醇市場的情況非常相似。

There's one other brand that's in there that I think does about $35 million a year, and that's been out there maybe two years.

還有另一個品牌，我認為它每年的銷售額約為 3500 萬美元，而且已經存在了兩年了。

And so we would be coming in to that.

所以我們會討論這個問題。

So we do have the better product, but we're always going to be up against people who want to go with the generic option.

所以我們確實有更好的產品，但我們總是會遇到那些想要使用通用選項的人。

And this is why we are pricing our product basically at the same as the generic co-pay so that the economics do not become an issue when using us and we're going to see what happens over the next two years by doing this strategy of what we call value pricing.

這就是為什麼我們的產品定價基本上與通用共付額相同，這樣在使用我們時經濟就不會成為問題，我們將透過執行這項策略來看看未來兩年會發生什麼我們所說的價值定價。

And if it takes off the way we suspect after talking with customers, then I would be very happy to come back here a year or two from now and say, you know, that number is much higher than I thought.

如果它像我們在與客戶交談後懷疑的那樣發展，那麼我會很高興在一兩年後回到這裡並說，你知道，這個數字比我想像的要高得多。

And have you started speaking with the payers, do you have any progress to report yet we're doing the entire thing cash.

您是否已經開始與付款人交談，您是否有任何進展需要報告，但我們正在以現金方式完成整個事情。

We're working with an e-pharmacy as well as getting the wholesale licenses because about 85% of ophthalmic surgeons sell the steroid right out of their office.

我們正在與電子藥局合作並獲得批發許可證，因為大約 85% 的眼外科醫生直接在辦公室外銷售類固醇。

And so the way we're doing this is as a wholesaler, we'll be supplying the physician offices and for individual patients, they'll be using an e-pharmacy one they're very familiar with.

因此，我們這樣做的方式是作為批發商，我們將為醫生​​辦公室和個別患者提供服務，他們將使用他們非常熟悉的電子藥房。

And the entire thing is cash again, the same as a branded co-pay.

整件事情又是現金，就像品牌自付費用一樣。

So there's no insurance issues.

所以不存在保險問題。

There's no callbacks.

沒有回調。

There's none of the things that are both timely and costly for the physicians.

對醫生來說，沒有一種方法是既及時又昂貴的。

Great.

偉大的。

Thank you.

謝謝。

Thank you.

謝謝。

Thank you.

謝謝。

We have reached the end of our question and answer session.

我們的問答環節已經結束。

And with that, I would like to turn the floor back over to Michael Rowe for closing comments.

說到這裡，我想把發言權交還給邁克爾·羅（Michael Rowe）以供結束評論。

Thank you, and thank all of you for joining us today.

謝謝大家，也謝謝大家今天加入我們。

And that concludes today's call.

今天的電話會議到此結束。

We are very pleased with our progress to date, and we are very well positioned to continue our current momentum as our long-term commercial plan and strategy continues to emerge.

我們對迄今為止的進展感到非常滿意，並且隨著我們的長期商業計劃和策略的不斷出現，我們已經做好了繼續當前勢頭的準備。

So thank you again for joining us and we look forward to talking again with you for our first quarter update in the spring.

再次感謝您加入我們，我們期待再次與您討論春季第一季的更新。

This concludes today's teleconference.

今天的電話會議到此結束。

You may disconnect your lines at this time.

此時您可以斷開線路。

Thank you for your participation.

感謝您的參與。