Hyperion DeFi Inc (HYPD) 2023 Q4 法說會逐字稿

Greetings, and welcome to the Eyenovia fourth quarter and full year 2023 earnings call. (Operators Instructions) And as a reminder, this conference is being recorded.

大家好，歡迎參加 Eyenovia 2023 年第四季和全年財報電話會議。（操作員指示）提醒一下，本次會議正在錄音。

It is now my pleasure to introduce your host, Eric Ribner of Investor Relations. Thank you. You may begin.

現在我很高興介紹您的主持人，投資者關係部門的 Eric Ribner。謝謝。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. With me today are Eyenovia's Chief Executive Officer, Michael Rowe; Chief Financial Officer John Gandolfo; and Chief Operating Officer, Bren Kern.

下午好，歡迎參加 Eyenovia 2023 年第四季和全年財報電話會議和音訊網路廣播。今天與我一起的有 Eyenovia 的首席執行官 Michael Rowe；財務長 John Gandolfo；以及首席營運長Bren Kern。

This afternoon, we issued a press release announcing financial results for the 3 and 12 months ended December 31, 2023. 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 31, 2023, which was filed with the SEC.

今天下午，我們發布了一份新聞稿，宣布了截至 2023 年 12 月 31 日的第三季和十二個月的財務表現。我們鼓勵大家閱讀今天的新聞稿以及 Eyenovia 向美國證券交易委員會提交的截至 2023 年 12 月 31 日的 10-K 表季度報告。

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 上查閱。此外，本次電話會議將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. 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.

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。另請注意，今天電話會議上討論的某些資訊屬於《私人證券訴訟改革法案》安全港條款的涵蓋範圍。

We caution listeners that during the call, Eyenovia's management will be making forward-looking statements. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are subject to a number of risks which are described in more detail in our annual report on Form 10-K.

我們提醒聽眾，Eyenovia 的管理層將在通話期間發表前瞻性陳述。由於公司業務相關的風險和不確定性，實際結果可能與這些前瞻性陳述明確或暗示的結果有重大差異。這些前瞻性陳述受多種風險的影響，這些風險在我們的 10-K 表年度報告中有更詳細的描述。

This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, March 18, 2024. Eyenovia undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as may be required by applicable securities law.

本次電話會議包含時間敏感訊息，僅截至本次直播之日（2024 年 3 月 18 日）準確。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召開日後事件或情況的義務，除非適用的證券法另有要求。

With that said, I'd like to turn the call over to Michael Rowe, Eyenovia's Chief Executive Officer, Michael, the floor is yours

說到這裡，我想把電話轉給 Eyenovia 的執行長 Michael Rowe，Michael，現在由你來發言

Thank you, Eric. And welcome, everyone, to our fourth quarter and full year 2023 financial results conference call. Last quarter, I talked about how Eyenovia (technical difficulty) as we continue our growth into a development and commercial organization. Those levers were revenues agreements and sources of capital.

謝謝你，埃里克。歡迎大家參加我們的 2023 年第四季和全年財務業績電話會議。上個季度，我談到了 Eyenovia（技術難度），以及我們如何繼續成長為開發和商業組織。這些槓桿是收入協議和資金來源。

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 3. 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.

今天，我將與大家分享我們如何執行這三個槓桿，特別是在我們推進的商業策略方面，該策略將繼續加速推進，目前已有兩款產品獲批，還有兩款產品進入第三階段。我還將分享我們達成的兩項重要協議的消息，這兩項協議將補充我們自己的銷售工作，並提供我們針對乾眼症的計劃的最新資訊。

Bren will then take us through the build-out of our manufacturing capabilities, which are now fully integrated and producing commercial supply of Mydcombi. And finally, John will provide an update on the third lever, our financials and the options we are exploring towards ultimately reaching a breakeven point for the company.

然後，布倫將帶我們了解我們的製造能力的建設，現在我們的製造能力已經完全整合，並可以進行 Mydcombi 的商業供應。最後，約翰將介紹第三個槓桿的最新情況，即我們的財務狀況以及我們正在探索的最終使公司達到盈虧平衡點的選擇。

So let's dive right into it with our two FDA approved products clobetasol propionate ophthalmic suspension 0.05% and Mydcombi. As you may recall, the US commercial rights for clobetasol were acquired from Taiwan based Formosa Pharmaceuticals last August. Just last week, we transferred the NDA for clobetasol from Formosa over to Eyenovia.

那麼讓我們直接深入研究一下我們的兩種經 FDA 批准的產品：0.05% 丙酸氯倍他索眼用混懸液和 Mydcombi。您可能還記得，氯倍他索的美國商業權利是去年 8 月從台灣的台塑製藥公司收購的。就在上週，我們將氯倍他索的 NDA 從 Formosa 轉移到了 Eyenovia。

Clobetasol was approved just two weeks ago on March 4, this unique post ocular surgery steroid is the first product developed using Formosa's proprietary APNT nanoparticle formulation platform. 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.

氯倍他索於兩週前的3月4日獲得批准，這種獨特的眼科手術後類固醇是使用台塑專有的APNT奈米顆粒配方平台開發的第一款產品。此技術可減小活性藥物成分的粒度，且具有較高的均勻性和純度，從而可滲透到眼睛的相關區域，最終提高生物利用度。

Clobetasol is a potent steroid indicated for pain and inflammation following ocular surgery. This is the first time that this molecule is available in ophthalmology. Its efficacy and safety profile is highly desirable. With nearly 9 out of 10 patients achieving complete absence of postsurgical pain and 6 out of 10 achieving total absence of inflammation within 15 days post ocular surgery.

氯倍他索是一種強效類固醇，用於緩解眼科手術後的疼痛和發炎。這是該分子首次應用於眼科領域。其功效和安全性令人高度讚賞。在眼科手術後 15 天內，幾乎 90% 的患者完全不再出現術後疼痛，60% 的患者完全不再發炎。

Clobetasol has an advantageous dosing profile of twice-a-day without titration versus existing treatments, which require dosing up to four times a day. This is particularly important as eye surgery patients are often on multiple drugs during recovery. So any advancement which simplifies the treatment regimen would be welcomed eye doctors and patients alike.

與現有的每天需要服藥四次的治療方法相比，氯倍他索具有每天兩次且無需滴定的給藥方式的優勢。這一點尤其重要，因為眼科手術患者在康復期間通常需要服用多種藥物。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。

And in terms of safety, side effects were seen and no more than 2% of patients. And our label mentions that some of these side effects could have been the result of the surgical procedure itself. You can find additional information and full prescribing information at clobetasolbid.com.

而在安全性方面，出現副作用的患者則不超過2%。我們的標籤提到，其中一些副作用可能是手術本身的結果。您可以在 clobetasolbid.com 上找到更多資訊和完整的處方資訊。

It is estimated there are more than 7 million ocular surgeries in the US each year, most which are treated with topical ocular steroids in steroid combinations currently totaling $1.3 billion in sales. 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.

據估計，美國每年有超過 700 萬例眼科手術，大多數採用局部眼部類固醇組合治療，目前總銷售額為 13 億美元。這是一個非常重要的市場機會，我們認為我們能夠在未來三到四年內佔據中等個位數的市場份額。

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

我們將氯倍他索視為我們商業產品組合的重要補充，這將使我們能夠進一步利用現有的銷售團隊。我們相信，與我們的散瞳產品 Mydcombi 一起，我們可以為眼科診所和外科中心帶來巨大的價值，並且我們正在努力爭取在今年晚些時候我們的合作夥伴獲得台灣出口許可後，盡快實現氯倍他索的強勁商業化上市。

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

從長遠來看，我們看到了一個潛在的機會，即為我們的 Optejet 分配器開發一種氯倍他索配方，作為治療乾眼症的潛在藥物，該市場的規模估計超過 36 億美元。為此，我們計劃在未來幾個月與 FDA 合作，討論該適應症的未來發展方向。

While clobetasol is a great product for us, it is only half of our revenue story. Mydcombi is the other half. As you know, Mydcombi is the first and only FDA approved fixed combination of two pupil dilation drugs, tropicamide and phenylephrine. And the first ophthalmic spray using the Optejet platform.

雖然氯倍他索對我們來說是一款很棒的產品，但它只是我們收入的一半。Mydcombi 是另一半。如您所知，Mydcombi 是第一個也是唯一一個獲得 FDA 批准的兩種瞳孔擴張藥物托吡卡胺和苯腎上腺素的固定組合。以及第一款採用Optejet平台的眼科噴霧器。

When our sales force talks with customers, they highlight how our products can help bookend the surgery by using Mydcombi as their [mid-patriotic] agent, pre-surgery and clobetasol as their steroid post-surgery. 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.

當我們的銷售人員與客戶交談時，他們會強調我們的產品如何透過在手術前使用 Mydcombi 作為他們的 [中愛國] 藥物、在手術後使用氯倍他索作為他們的類固醇來幫助完成手術。目前，我們已僱用、培訓並部署了 10 名現場銷售人員中的一半，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 Mydcombi now licensed for sale in 16 states representing more than half of the US targeted population. We have a dozen other license applications in process.

此外，我們在滿足國家商業許可要求方面繼續取得了巨大進展。Mydcombi 目前已獲准在 16 個州銷售，占美國目標人口的一半以上。我們還有十幾個其他許可證申請正在處理中。

In terms of manufacturing, in November, we were very pleased to announce that our contract manufacturer Coastline International was approved by the FDA for Mydcombi commercial manufacturing. We also recently announced FDA approval of our Redwood City facility as a commercial manufacturing facility.

在製造方面，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 Mydcombi 商業製造。我們最近也宣布 FDA 批准我們的紅木城工廠作為商業製造工廠。

With Redwood City, Reno and Coastline now all online. We have commenced the manufacture of commercial supply of Mydcombi, and we now have finished product moving into and out of our warehouse. Bren will provide a more detailed manufacturing update in a moment.

紅木城、雷諾和海岸線現已全部上線。我們已經開始生產 Mydcombi 的商業供應，現在成品已經進出我們的倉庫。布倫稍後將提供更詳細的製造更新資訊。

Customer feedback on Mydcombi has been excellent. 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 Mydcombi as an approved product for its membership.

客戶對 Mydcombi 的回饋非常好。為了進一步說明這一點，我們非常高興地宣布，Vision Source（一家擁有約 3,000 家本地驗光機構的領先網絡）已將 Mydcombi 添加為其會員的認可產品。

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

我們對銷售管道寄予厚望，因為 Mydcombi 對於那些以患者為中心並選擇採用 Mydcombi 來增強患者全面眼科檢查體驗的辦公室尤其有益。

As we like to say these offices and doctors use Mydcombi because they care for their patients. The current US 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.

正如我們所說，這些辦公室和醫生使用 Mydcombi 是因為他們關心他們的病人。目前，美國瞳孔擴張器市場的價值約為 2.5 億美元，我們認為，我們有能力在未來幾年內佔據很大一部分市場份額，特別是當我們轉向下一代設備時。

Staying on the topic of Mydcombi for a moment, 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. The study was conducted by Dr. Denise Pencil of the State University of New York School of Optometry. 29 subjects were treated with a half dose of Mydcombi, which is 8 microliters per eye.

繼續討論 Mydcombi 這個主題，我們最近完成了一項研究，以確定是否存在可以有效地使藥物敏感患者瞳孔擴張的較低劑量。這項研究由紐約州立大學視光學院的丹尼斯佩西爾博士進行。 29 名受試者接受了半劑量 Mydcombi 治療，即每隻眼睛 8 微升。

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. Almost all patients return to a pupil size of less than 5 millimeters between three and a half hours, six hours post installation.

在該研究中，服藥後 30 分鐘，約三分之二的患者出現臨床相關的瞳孔擴張，60 分鐘後該百分比增加。幾乎所有患者的瞳孔大小在安裝後三個半小時至六個小時內都會恢復到 5 毫米以下。

This is similar to the time seen in published studies of patients exposed to tropicamide eyedrops and a mydriasis reversal drug. The dose was well tolerated with minimal adverse events reported with three subjects reporting mild instillation sight pain and one with mild dry eye upon installation.

這與已發表的研究中患者使用托吡卡胺眼藥水和散瞳逆轉藥物所見的時間相似。此劑量耐受性良好，報告的不良事件極少，其中三名受試者報告滴注後出現輕微視力疼痛，一名受試者報告滴注後出現輕微乾眼症。

Given that a standard of care mydriasis agent phenylephrine may present safety risks in a few older patients, the greater dosing flexibility enabled by Mydcombi 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 US each year. We plan to publish the full results in a peer reviewed journal later this year.

鑑於標準的散瞳劑苯腎上腺素可能對少數老年患者造成安全風險，Mydcombi 和 Optejet 所帶來的更大的劑量靈活性可以滿足美國每年約 1000 億次綜合和糖尿病眼科檢查以及超過 400 萬次白內障手術中尚未滿足的需求。我們計劃今年稍晚在同行評審期刊上發表完整結果。

As previously mentioned, we will soon have 10 sales representatives and two sales directors in the field to commercialize Mydcombi and clobetasol. Half of this team is already trained and in place working every day to present the benefits our products and pull the revenue lever.

如前所述，我們很快將有 10 名銷售代表和 2 名銷售總監在現場推廣 Mydcombi 和氯倍他索。團隊中有一半成員已經接受過培訓，並且每天都在工作，以展示我們產品的優勢並增加收入。

Additionally, we recently announced a co-promotion agreement with NovaBay, a leading developer of anti-infective eye products. For the terms of that agreement, NovaBay will promote clobetasol to hundreds of eye care professionals that our salespeople are not calling on. So it's telephone based sales people.

此外，我們最近宣布與領先的抗感染眼部產品開發商 NovaBay 達成聯合推廣協議。根據該協議的條款，NovaBay 將向我們的銷售人員未拜訪的數百名眼科護理專業人士推廣氯倍他索。所以是電話銷售人員。

They will also conduct outreach to doctors in those geographic areas that our salespeople are not currently covering. Meanwhile, our field sales force will promote their prescription Avenova Antimicrobial Lid and Lash Solution to our doctors, who can include this product in their suite of pre and post-surgical offerings.

他們也將向我們的銷售人員目前尚未涵蓋的地區的醫生進行推廣。同時，我們的現場銷售人員將向我們的醫生推廣他們的處方 Avenova 抗菌眼瞼和睫毛解決方案，他們可以將此產品納入他們的術前和術後產品套件中。

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

除了雙方獲得額外的促銷和潛在銷售的好處之外，雙方還將獲得其產生的銷售額的一定比例。這是提升我們商業銷售範圍的一種極具成本效益的方式，我們相信這項協議對雙方都非常有利。

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

總之，我們正在積極推廣 Mydcombi，並將利用與 Vision Source 的新協議。我們正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 月從博士倫公司重新收購美國和加拿大的商業和開發權，重新推出 MicroPine，重新加載我們的產品線。

MicroPine is an investigational 8 microliter ophthalmic spray of [atropine] delivered by the Optejet. Micropine is being evaluated as a potential treatment for pediatric progressive myopia for worsening near sightness, which is characterized by elongation of the sclera and retina.

MicroPine 是一種由 Optejet 輸送的 8 微升 [阿托品] 眼科噴霧劑，正在研究中。Micropine 正在被評估為一種治療兒童進行性近視的潛在療法，用於治療兒童近視惡化，其特徵是鞏膜和視網膜拉長。

We estimate that more than 25 million children in the US suffer from myopia and of these 5 million are believed to be at high risk for progressive myopia. If left untreated, progressive myopia can ultimately lead to significant vision loss and potential blindness. Prior studies have demonstrated that atropine can slow myopia progression by as much as 60%. And there is a significant unmet need for safe and effective FDA approved pharmaceutical treatment options.

我們估計，美國有超過 2,500 萬名兒童患有近視，其中 500 萬名兒童患有進行性近視的風險較高。如果不及時治療，逐漸加重的近視最終會導致視力嚴重喪失，甚至失明。先前的研究表明，阿托品可以將近視的發展減緩 60%。此外，對於經 FDA 批准的安全有效的藥物治療方案，仍存在巨大的未滿足需求。

In terms of next steps, we are continuing to advance to Phase 3 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.

在接下來的步驟方面，我們將繼續推進第 3 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, we are working on a planned interim look at the CHAPERONE data later this year. 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.

一個選擇是，我們正在計劃在今年稍後對 CHAPERONE 數據進行中期審查。如果該中期分析成功，我們可能會看到一個大大降低風險的項目，這對我們自己或商業化合作夥伴來說都非常有吸引力。

Lastly, we are maintaining MicroPine or Apersure in our portfolio should the presbyopia market shows signs of improvement. Right now, our opinion is that we can make better use of our capital elsewhere in our portfolio. So we can turn very quickly back to this product candidate if the situation should change. So this gives us line of sight to three and possibly four commercial revenue-generating products.

最後，如果老花眼市場出現改善跡象，我們將在我們的投資組合中保留 MicroPine 或 Apersure。目前，我們認為我們可以更好地利用我們投資組合中的其他地方的資本。因此，如果情況發生變化，我們可以很快回到這個候選產品。因此，這讓我們看到了三款甚至四款商業創收產品的前景。

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. 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.

我們繼續探索新型治療方法的開發，利用 Optejet 治療乾眼症、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。這些潛在的合作關係正在不斷推進，我們期待在所有設備相容性工作完成後，在達成全面開發協議的階段分享更多資訊。

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

現在，我想將電話轉給我們的營運長布倫·科恩 (Bren Kern)，以了解我們的製造業最新情況。布倫？

Thank you, Michael. 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 meets high levels of reliability and sterility. 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.

謝謝你，麥可。在第四季度以及今年年初，我們將繼續執行我們的策略，以維持對製造流程的控制，確保我們的產品滿足高水準的可靠性和無菌性。提醒一下，我們使用合約製造商為我們提供藥物成分，然後我們用這些藥物在我們的雷德伍德城工廠填充藥筒。

These cartridges are then married with our electronic base units, which are manufactured at our Reno, Nevada facility. We are now fully capable of supporting our current anticipated Mydcombi commercial demand as well as the needs for ongoing MicroPine development in 2024.

然後將這些墨盒與我們位於內華達州里諾的工廠生產的電子基座單元結合在一起。我們現在完全有能力支持我們目前預期的 Mydcombi 商業需求以及 2024 年持續的 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. This approval will provide Redwood City with the ability to perform final assembly, packaging and labeling activities in support of Mydcombi and complements our Reno facilities and contract manufacturers.

更具體地說，上個月，我們非常高興地獲得 FDA 對我們紅木城工廠的批准，並且該機構沒有提出任何重大擔憂。此項批准將使 Redwood City 能夠執行最終組裝、包裝和標籤活動，以支持 Mydcombi，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 Mydcombi commercial supply. Redwood City will also be the manufacturing site of our Gen-2 device, which has significantly fewer parts in our existing device, making its manufacturing easier and more reliable.

如前所述，Coastline International 也獲得了 FDA 批准，目前正在生產 Mydcombi 商業供應。紅木城也將成為我們第二代設備的生產基地，該設備的零件數量明顯少於我們現有的設備，因此製造起來更容易、更可靠。

We are targeting Mydcombi as the first product that will be available in Gen-2. And our Redwood City facility is actually making product to begin engineering stability studies and registration batches before the end of the year.

我們的目標是讓 Mydcombi 成為第二代推出的首款產品。我們位於雷德伍德城的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-1 to Gen-2 will be the subject of an FDA meeting this summer. And assuming we come to an agreement, demonstrating comparability between the two devices should provide a path for Eyenovia to introduce the Gen-2 platform into the commercial market.

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。假設我們達成協議，展示兩種裝置之間的可比性應該為 Eyenovia 將 Gen-2 平台引入商業市場提供一條途徑。

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

我們的里諾工廠還生產 Optejet 噴射器和底座以支援 Mydcombi，並透過改進我們最先進的設備繼續擴大生產能力。竣工後，新工廠將顯著提高注射器的製造能力，滿足我們的商業和臨床產品需求。

As noted earlier this year, Eyenovia has reacquired the rights to MicroPine. Micropine is an investigational 8 microliters ophthalmic spray of atropine delivered by Eyenovia's proprietary Optejet device being evaluated as a potential treatment for pediatric progressive myopia characterized by elongation of the retina.

正如今年早些時候所指出的，Eyenovia 已經重新獲得了 MicroPine 的版權。Micropine 是一種試驗性的 8 微升阿托品眼科噴霧劑，由 Eyenovia 專有的 Optejet 設備輸送，目前正在評估其作為治療以視網膜拉長為特徵的兒童進行性近視的潛在方法。

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

我們正積極提升MicroPine在這方面的臨床管理能力，預計將在今年4月中旬完成。在 MicroPine 的管理下，Eyenovia 將與 FDA 進行溝通，討論加快完成研究的機會。

I continue to be excited about our recent successes and the progress we are making. We now have two FDA approved manufacturing sites that we manage, for turning us to meet the market demands for our products. I'm looking forward to expanding on the significant achievements to be made in this year.

我對我們最近的成功和取得的進展繼續感到興奮。我們目前管理兩個經 FDA 批准的生產基地，以滿足我們產品的市場需求。我期待著進一步擴大今年所取得的重大成就。

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

現在，我想將電話轉給我們的財務長約翰甘道夫 (John Gandolfo)，以提供財務最新情況。約翰？

Thank you, Bren. 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.

謝謝你，布倫。2023 年第四季度，我們報告淨虧損約 800 萬美元或每股 0.18 美元，加權平均流通股約 4,540 萬股。

This includes a $0.02 loss related to the one-time repatriation costs for bringing MicroPine back to Eyenovia from [Bausch]. 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.

這包括將 MicroPine 從[鮑施]。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，加權平均流通股約為 3,590 萬股。

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

2023 年全年，我們報告淨虧損約 2,730 萬美元，即每股 0.66 美元，加權平均流通股約 4,100 萬股。相比之下，2022 年全年的市值為 2,800 萬美元，即每股 0.83 美元，加權平均流通股數約為 3,360 萬股。

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 年第四季研發費用總計約 410 萬美元，而 2022 年第四季為 220 萬美元，成長 84.6%。2023 年全年研發費用下降約 3% 至 1,300 萬美元，而 2022 年全年為 1,340 萬美元。

The full year decrease was driven primarily by lower direct clinical and non-clinical 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下降，以及未來向我們的許可合作夥伴交付臨床供應的相關成本的遞延。

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

2023 年第四季，一般及行政費用約為 340 萬美元，而 2022 年第四季為 320 萬美元，成長 7.3%。2023 年全年，一般及行政開支較 2022 年全年的 1,350 萬美元下降約 8.1% 至 1,240 萬美元。全年下降主要是由於法律費用和高管招聘成本的同比減少。

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. 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.

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。這意味著增長了約 39%。2023 年全年總營運費用為 2,540 萬美元，較 2022 年全年的 2,690 萬美元下降約 5.6%。

As of December 31, 2023, company's cash balance was approximately $14.8 million as compared to $22.9 million as of December 31, 2022. We are currently reviewing -- evaluating various structures and alternatives to increase our cash resources in order to fund our corporate strategy going forward.

截至 2023 年 12 月 31 日，本公司的現金餘額約為 1,480 萬美元，而截至 2022 年 12 月 31 日為 2,290 萬美元。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，為我們未來的公司策略提供資金。

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. Regarding our prior partnership with Bausch & Lomb, as Michael mentioned earlier, we reacquired the development and commercial rights to MicroPine, now taken over continued execution of the ongoing Phase 3 CHAPERONE trial.

現在，我將提供有關我們與 Arctic Vision 就我們在中國和韓國的所有三種產品達成的現有許可協議的最新資訊。關於我們之前與博士倫的合作，正如邁克爾之前提到的，我們重新獲得了 MicroPine 的開發和商業權利，現在接管了正在進行的 3 期 CHAPERONE 試驗的繼續執行。

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

我們與 Arctic Vision 的協議涵蓋 MicroPine、MicroLine 和 Mydcombi，並為我們提供銷售、特許權使用費以及開發里程碑。MicroPine 在中國為兒童近視治療帶來了重大機會。如果獲得批准，MicroPine 可能成為我們公司長期內一個潛在的、有意義的非稀釋性資金來源。

To date, our 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.

到目前為止，我們的授權協議已產生了約 1,600 萬美元的授權費，並且我們有可能在未來三到四年內從 Arctic Vision 獲得額外的 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. 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 and additional large ophthalmic indications beginning with dry eye.

如果我們的產品獲得商業化批准，Eyenovia 也有資格獲得可觀的銷售特許權使用費。我們正在繼續評估與 Formosa 協議類似的潛在管道擴展機會，並且我們將繼續利用 Optejet 技術來滿足尚未滿足的需求以及從乾眼症開始的其他大型眼科適應症。

In conclusion, 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.

總而言之，我們對 2023 年第四季以及後續期間的表現非常滿意。總結我們今天的重點，我們從博士倫重新獲得了 MicroPine 在美國和加拿大的開發和商業化權利。

MicroPine is in Phase 3 as a potential treatment for progressive pediatric myopia, a potential blockbuster opportunity for the company. We announced FDA approval of clobetasol for the treatment of pain and inflammation following ocular surgery.

MicroPine 目前處於第 3 階段，是一種治療兒童進行性近視的潛在療法，對該公司來說是一個潛在的轟動性機會。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 for Mydcombi and one with NovaBay for clobetasol and Avenova. We finalized the build-out of our manufacturing capabilities to support Mydcombi production with Coastline manufacturing and our Redwood City facility is now online in addition to our facility in Reno.

我們宣布了兩項重要協議以補充他們自己的銷售工作，一項是與 Vision Source 簽署的 Mydcombi 協議，另一項是與 NovaBay 簽署的 clobetasol 和 Avenova 協議。我們完成了製造能力的建設，以透過海岸線製造來支持 Mydcombi 的生產，除了裡諾的工廠外，我們的紅木城工廠現在也已上線。

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的潛力的有希望的途徑。

That concludes our prepared remarks. We would now like to turn the call open -- call over for questions. Operator?

我們的準備好的演講到此結束。我們現在想開放電話會議——回答問題。操作員？

Thank you. We will now be conducting a question-and-answer session. (Operator Instructions)

謝謝。我們現在將進行問答環節。（操作員指令）

Tim Lugo, William Blair.

提姆·盧戈、威廉·布萊爾。

Thanks for the questions. Now that MicroPine has been brought back to the company and you have the rights. Can you talk about this accelerating the development of the program? I know, in the remarks you mentioned, you're engaged with the agency about this possibility, maybe I'd love to hear some initial thoughts around what you could do for this acceleration of the development.

感謝您的提問。現在 MicroPine 已被帶回公司，您擁有權利。您能談談這對該計劃的加速發展有何影響嗎？我知道，在您提到的評論中，您正在與該機構討論這種可能性，也許我很想聽聽您可以為加速發展做些什麼的初步想法。

Yes, Tim, thank you for the question. 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 results from one of the arms of this study.

是的，提姆，謝謝你的提問。我們的目的是在今年稍後對協議進行修訂，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出顯著的結果。

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

我們也會與 FDA 討論這個問題，因為如果我們這樣做，並且安慰劑對照研究取得成功，我們也許可以提出這樣的論點：繼續使用安慰劑組確實是不道德的，如果我們可以證明我們已經發生了重大事件，並且這可以將研究時間縮短數年，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. 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.

因此，我們的策略是在今年年底進行中期分析。如果成功的話，我們可以與 FDA 商討如何儘早結束這項研究，以便能夠轉向 NDA。

That's very helpful. Thank you.

這非常有幫助。謝謝。

You're welcome.

不客氣。

And regarding the [H2] study, is that something that Optejet can adjust to or do you need to submit an NDA to get it onto the label?

關於 [H2] 研究，Optejet 可以適應嗎，還是需要提交 NDA 才能將其加到標籤上？

Well, to get that onto the label, we would have to submit to the FDA. That study was done to answer a very specific medical question for specific populations. 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.

嗯，為了把它貼到標籤上，我們必須提交給 FDA。這項研究是為了解答特定族群的一個非常具體的醫學問題。因此，我們能夠使用 Optejet 進行調整，因為我們不想得到這個答案，看看是否可以降低這個特定需求。

Okay, fair enough. And for the NovaBay co-promotion, could you again, maybe you have this in the comments, and I missed it, but can you just scope out what capabilities that are playing into the margin on clobetasol?

好吧，夠公平。對於 NovaBay 聯合促銷，您能否再次說明一下，也許您在評論中提到了這一點，而我錯過了，但您能否指出哪些功能可以發揮氯倍他索的利潤作用？

They are bringing an in-house sales force that's very experienced doing telephone sales into cataract surgeons. They do it now for their product Avenova. So they would take that experience and do the same for clobetasol in those areas where we do not have salespeople. So essentially they will extend our reach into those offices. And every time they're successful, they will get a percentage of that sale.

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。他們現在對其產品 Avenova 也這麼做。因此，他們會吸取這項經驗，在我們沒有銷售人員的地區對氯倍他索採取同樣的措施。因此從本質上來說，他們會將我們的業務範圍拓展到這些辦公室。每當他們成功時，他們就會獲得一定比例的銷售量。

And likewise, we can hand carry their product Avenova 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. 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.

同樣，我們可以將他們的產品 Avenova 親自帶到我們確實有銷售人員的白內障外科醫生那裡，因為這是他們許多實踐的一部分，而且當我們成功時，我們就會獲得一部分收益。所以從根本上來說，這是一種無需額外成本就能擴大我們的促銷範圍並同時有機會賺取一些錢的方法。

Understand, it make sense. Thank you.

明白了，很有道理。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. Just wanted to first focus on your commercial programs. Can you help us understand the kind of potential launch trajectories for both clobetasol and Mydcombi and what we should expect, I guess, this year and going into next specifically?

嘿，大家晚上好，感謝你們回答問題，並祝賀你們取得的進展。我首先只想關註一下您的商業計劃。您能否幫助我們了解氯倍他索和 Mydcombi 的潛在發布軌跡，以及我們對今年和明年的具體預期？

Yeah. Hi, Matt, it's good to have your call. John, I believe that there have been analysts out there that have spoken to this. I know we haven't given guidance, but maybe you can talk to what our reaction has been to the analysts?

是的。你好，馬特，很高興接到你的電話。約翰，我相信已經有一些分析師談論過這個問題。我知道我們還沒有給出指引，但也許你可以談談我們對分析師的反應是什麼？

Yeah. So the analysts do have numbers in their model out there, and we're very comfortable with the analyst estimates that are out there for the balance of 2024. At this point, we're not going to give revenue guidance ourselves. We'll reevaluate that at the end of the year after these products have been in the market for a while. But overall, I think we're comfortable with the analysts' estimates that are out there.

是的。因此，分析師的模型中確實有一些數字，而且我們對分析師對 2024 年餘額的估計非常滿意。目前，我們自己不會提供收入指引。這些產品上市一段時間後，我們會在年底重新評估。但總體而言，我認為我們對現有的分析師估計感到滿意。

Okay. That's helpful. And maybe just to focus in on a little bit with your new sign agreement with a Vision Source. You mentioned that there are about 3,000 offices that are associated with that. 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?

好的。這很有幫助。或許只是稍微關心一下您與 Vision Source 簽署的新協議。您提到大約有 3,000 個辦公室與此相關。隨著你們繼續在 Mid-Con 上推出新產品，我們是否應該期待更多類似的額外交易或合作？

Yeah, absolutely. So this is the first one that signed. We do have others that are in the signature phase, and they're a mix. Some of them are like Vision Source where it's for the retail optometrist. Others are with large institutions where they are looking to replace their disposable use of major navigation agents.

是的，絕對是如此。所以這是第一個簽的。我們確實還有其他處於簽名階段的項目，它們是混合的。其中有些像 Vision Source，是專門為零售驗光師服務的。其他一些機構則來自大型機構，他們希望用這些機構來取代一次性使用的主要導航代理商。

What they do now is they use bottle once 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 with Mydcombi. 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.

他們現在的做法是，使用一次瓶子然後將其扔掉，這對他們來說成本很高，每次給患者這樣做就要花費 15 美元，所以他們會用 Mydcombi 來代替。我們現在正在努力簽署一些協議，這些協議基本上將出現在他們的處方集上，以取代他們現在所做的。

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

然後轉到您的產品線，您的第二代設備，您能否告訴我們更多有關它的信息，它與第一代設備有何不同，以及我們何時可以預期它在市場上與 Mydcombi 一起使用？

Yeah, Bren, would you like to give a high-level discussion about Gen-2?

是的，布倫，你願意就第二代 (Gen-2) 進行高層討論嗎？

Absolutely. So our Gen-2 product offers simplification from a manufacturing capability, enabling us to produce these more easily with high reliability. With Mydcombi being the first platform that we're going to take that into, we're actually actively working on our registration batches to be completed this year. And then we'll be speaking with the FDA on getting the Gen-2 platform into Mydcombi, hopefully early next year after we did the registration batches put out.

絕對地。因此，我們的 Gen-2 產品在製造能力上提供了簡化，使我們能夠更輕鬆地生產高可靠性的產品。Mydcombi 是我們引入該技術的第一個平台，我們實際上正在積極致力於今年完成註冊批次。然後，我們將與 FDA 商談將 Gen-2 平台納入 Mydcombi，希望是在明年年初我們完成註冊批次之後。

Okay, great. 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?

好的，太好了。關於您的乾眼症治療項目，您能否向我們詳細介紹一下，以及我們預計今年何時將其引入臨床？

Yeah. We actually have three things that we're working on. We have acute dry eye that we're in discussions with Formosa. For clobetasol, 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. And then we have a third one that also would be in chronic, a different molecule that we're working on.

是的。實際上我們正在做三件事。我們患有嚴重的乾眼症，正在與 Formosa 進行討論。對於氯倍他​​索，我們患有慢性乾眼症，實際上我們正在與一家公司積極合作，我們正在努力將他們的藥物放入 Optejet 中，並確保它完全相容。然後我們還有第三種也是慢性的，我們正在研究一種不同的分子。

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

因此，我們想要做的是製定合作協議，而根據該合作協議，我們正在解決所有 CMC 問題，即如何將您的藥物以[連續]方式運送到我們的工廠？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. And that's when we'll talk about it publicly.

所有這些過程需要四到六個月的時間。一旦完成，就可以選擇開發協議。到那時我們就會公開談論它。

Okay, great. Thanks again for taking the questions.

好的，太好了。再次感謝您回答這些問題。

Thanks, Mathew.

謝謝，馬修。

Matthew Caulfield, H.C. Wainwright.

馬修·考爾菲爾德，H.C.溫賴特。

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

嘿，麥可和他的團隊，感謝你們回答我們的問題。那麼，氯倍他索計劃針對 Optejet 的發展和乾眼症，是否存在任何類似的優勢，那麼最終，在批准的術後疼痛適應症中使用 Optejet 呢？

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

謝謝馬修提出這個問題。答案是肯定的，我認為對於白內障患者和其他術後患者來說，使用 Optejet 比使用滴管要容易得多，我們當然可以回頭再看看這一點。

What we would have to do basically is run a pain study, although only one of them pain and inflammation because according to the FDA, the Optejet delivers an ophthalmic spray, which is a different form than a ophthalmic solution. So it requires a Phase 3 study.

我們要做的基本上是進行一項疼痛研究，儘管其中只有一項是疼痛和炎症，因為根據 FDA 的說法，Optejet 提供的是眼科噴霧劑，這與眼科溶液的形式不同。因此它需要進行第三階段的研究。

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

這是一件好事，因為它使得用眼藥水代替 Optejet 成為不可能。因此，從一般角度來看，你不能簡單地將我們放入 Optejet 中的分子替換為眼藥水形式的東西。這是一件好事。

But on the other hand, it causes us a little bit more time to get something approved. So the strategy was let's get this additional indication for dry eye, which is a much bigger indication for the product. 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.

但另一方面，這會讓我們需要更多的時間來獲得批准。因此我們的策略是獲得乾眼症這一額外適應症，這對產品來說是一個更大的適應症。然後，我們可以決定回頭重新進行一項疼痛和發炎研究，並將其添加到 Optejet 上，最終超越 Optejet 平台。

Understood, very helpful. And then with 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?

明白了，很有幫助。然後，到 23 年年底，現金和等價物將達到 1,480 萬美元，我不知道我是否錯過了這一點，但您是否對當前的現金流有任何了解，僅僅是短期的？

John, would you take that?

約翰，你會接受嗎？

Yeah. I'll take that. 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.

是的。我接受。正如我在準備好的演講中提到的那樣，我們實際上正在評估我們擁有的所有不同機會，以及何時籌集現金以資助公司未來的策略。

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

歷史虧損額度一般為每季 450 萬至 500 萬美元，我們預期這情況不會改變。我們將看到研發費用有所減少，而與 MicroPine 研究相關的研發費用則有所增加。

So that's basically where we think the operating burn will come in for the year. We are expecting close to $2 million from Arctic Vision as well for a product development milestone going forward. So that gives you somewhat of a sense of where we see us from a cash standpoint.

所以，我們認為這基本上就是今年營業成本的來源。我們預計 Arctic Vision 也將提供近 200 萬美元的資金用於未來的產品開發里程碑。所以這可以讓你從現金的角度稍微了解我們的狀況。

That's great. Very helpful. I appreciate it guys, and congrats on the transition to a commercialized company.

那太棒了。非常有幫助。我很感激你們，並祝賀你們轉型為一家商業化的公司。

Thank you, Matthew. Appreciate that.

謝謝你，馬修。非常感謝。

Thanks, Matt.

謝謝，馬特。

Thank you.

謝謝。

Kemp Dolliver, Brookline Capital Markets.

布魯克林資本市場 (Brookline Capital Markets) 的 Kemp Dolliver。

So I have two questions. First, with regard to Apersure, what needs to change for you to start advancing that program again?

我有兩個問題。首先，關於 Apersure，您需要做哪些改變才能再次推進該計劃？

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

謝謝。很高興您來電並提出這個好問題。所以現在，這個市場相當穩定，美容產品的年銷售額約為 1400 萬美元或 1500 萬美元，甚至可能沒有那麼高。因此，我認為，要想在這個市場上取得成功，就需要大力推廣，重新推出這個產品。

So if I look at it, if we do it, it's $1 million to do the registration batches. It's $4 million to file the NDA. So that's $5 million. And that's without making the investments, try to lift the market. And that's pretty pricey in the market right now that's doing less than $15 million.

所以如果我看一下，如果我們這樣做，那麼進行註冊批次的成本就是 100 萬美元。提交保密協議的費用為400萬美元。所以是 500 萬美元。那是在不進行投資的情況下試圖提振市場。目前，這個價格在市場上相當昂貴，市場價值不到 1500 萬美元。

So there is already one approved product that's waiting on the sidelines, an eyedrop to come in. There's another one that's in Phase 3. I think at the end, there may be multiple eyedrop competitors in the market, but we would be the only Optejet.

目前已經有一種核准的產品正在等待上市，那就是眼藥水。還有一個正處於第三階段。我認為最終市場上可能會有多個眼藥水競爭對手，但我們是唯一一家 Optejet。

So if one or two of them come in and they're able to resurrect this market, 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. So we'll be happy to take our money and use it elsewhere. And then wait and know that we can pivot to this at any time.

因此，如果其中有一兩家公司加入，並且能夠重振這個市場，我們完全願意讓其他人來做這件事，我們帶著我們認為更好的產品加入，這對患者更好，對醫生也更好，在他們完成繁重的工作之後再加入。所以我們很樂意把錢用在其他地方。然後等待並知道我們可以隨時轉向這一點。

Is this something you would partner out possibly?

這是你們可能會合作的事情嗎？

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

我們會，而且我們當然可以與人們交談，但我認為目前市場對這個興趣並不大。所以，我認為有很多大公司也在旁邊等著看接下來會發生什麼事。

Great. Thank you. Second question is was on clobetasol and with your market share guidance, just to take the other side of the thought process. So you have a product with superior dosing. What's the gating factor with the update given that -- or the uptake given that advantage?

偉大的。謝謝。第二個問題是關於氯倍他索以及您的市場份額指導，只是為了從另一個角度思考。因此您擁有一款劑量優越的產品。鑑於這一優勢，更新的限制因素是什麼？

So if you look at the glaucoma market as a surrogate because it's very similar. You basically have 80% or 85% of the units are actually sold are generics. 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.

因此，如果您將青光眼市場視為替代品，因為它們非常相似。基本上，實際銷售的 80% 或 85% 的單位都是仿製藥。然後你有一小部分品牌產品，它們佔單位的 15%，但它們卻占到價值的 50% 左右。

So it would be very similar in the steroid market. There's one other brand that's in there, that I think does about $35 million a year, that's been out there maybe two years. And so, we would be coming into that. 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.

類固醇市場的情況也非常相似。其中還有另外一個品牌，我認為其每年的營業額約為 3500 萬美元，該品牌推出大約兩年了。所以，我們就會進入這個領域。因此，我們確實有更好的產品，但我們總是面臨那些想要選擇通用產品的人的競爭。

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，這樣在使用我們產品時經濟性就不會成為問題，我們將透過這種所謂的價值定價策略，看看未來兩年會發生什麼。

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.

如果在與客戶交談後，我們的預期實現了成長，那麼我會非常高興在一兩年後回到這裡並告訴我，這個數字比我想像的要高得多。

And have you started speaking with payers, do you have any progress report yet?

您是否已經開始與付款人溝通了？

We're doing the entire thing cash. 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.

我們全部都用現金來做。我們正在與電子藥局合作並獲得批發許可證，因為大約 85% 的眼科醫生直接在辦公室銷售類固醇。

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. And the entire thing is cash again, the same as a branded co-pay. So there's no insurance issues. There's no callbacks. There's none of the things that are both timely and costly for the physicians.

因此，我們的做法是，作為批發商，我們將向醫生辦公室和個人患者供貨，他們將使用他們非常熟悉的電子藥房。而且全部費用都是現金，與品牌共同支付相同。因此不存在保險問題。沒有回調。對醫生來說，沒有什麼事情是既及時又昂貴的。

Great. Thank you.

偉大的。謝謝。

Thank you.

謝謝。

Thank you. We have reached the end of our question-and-answer session. And with that, I would like to turn the floor back over to Michael Rowe for closing comments.

謝謝。我們的問答環節已經結束。最後，我想將發言權交還給麥可·羅，請他發表最後評論。

Thank you and thank all of you for joining us today. And that concludes today's call. 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.

謝謝大家，也謝謝大家今天的參與。今天的電話會議到此結束。我們對迄今為止的進展感到非常滿意，隨著我們的長期商業計劃和策略不斷湧現，我們完全有能力繼續保持目前的勢頭。

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

再次感謝您的加入，我們期待在春季第一季更新時再次與您交談。

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

今天的電話會議到此結束。現在您可以斷開您的線路。感謝您的參與。