Hyperion DeFi Inc (EYEN) 2023 Q2 法說會逐字稿

Greetings. Welcome to the Eyenovia Second Quarter 2023 Earnings Call. (Operator Instructions) As a reminder, this conference is being recorded.

問候。歡迎參加 Eyenovia 2023 年第二季財報電話會議。 （操作員指示）提醒一下，本次會議正在錄音。

At this time, I would like to hand the call over to your moderator, Eric Ribner of Investor Relations. Thank you. You may begin.

現在，我想將電話交給主持人，投資人關係部門的 Eric Ribner。謝謝。你可以開始了。

Good afternoon, everyone, and welcome to Eyenovia's Second Quarter 2023 Earnings Call -- Earnings Conference Call and Audio Webcast.

大家下午好，歡迎參加 Eyenovia 2023 年第二季財報電話會議－財報電話會議和音訊網路廣播。

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

今天與我一起的有 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 6 months period ending June 30, 2023. We encourage everyone to read today's press release as well as Eyenovia's quarterly report on Form 10-Q for the quarter ended June 30, 2023, which will be filed with the SEC tomorrow, August 11, and our most recent filed 10-K. 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 to the company's website and will be archived for future reference.

今天下午，我們發布了一份新聞稿，宣布了截至 2023 年 6 月 30 日的 3 個月和 6 個月的財務業績。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，本次電話會議將在公司網站上進行網路直播，並將存檔以供日後參考。

Please note that on today's call, we will be discussing products, product concepts and candidates, some of which have yet to receive FDA approval. Please also note that certain information discussed on the call today is covered under the safe harbor provision of the Private Securities Litigation Reform Act. We caution listeners that during the call, Eyenovia's management will be making forward-looking statements. Actual results could differ materially from those stated or implied by those 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 and other SEC filings.

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》安全港條款的保護範圍。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 表年度報告和其他 SEC 文件中有更詳細的描述。

This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 10, 2023. Eyenovia undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as may be required by applicable securities law.

本次電話會議包含時間敏感信息，這些信息僅在本次直播之日（2023 年 8 月 10 日）準確無誤。

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

說完這些，我想把電話轉給 Eyenovia 的執行長 Michael Rowe。 麥可？

Thank you, Eric, and welcome, everyone, to our second quarter 2023 financial results conference call.

謝謝 Eric，歡迎大家參加我們 2023 年第二季財務業績電話會議。

We have an extremely productive second quarter, and I am excited to share with you our progress this afternoon. During our last conference call, we spoke of our efforts to begin our targeted launch of Mydcombi and our goal of partnering with other companies to leverage and monetize the Optejet technology beyond our own development programs.

我們的第二季成果非常顯著，我很高興今天下午與大家分享我們的進展。在我們上次的電話會議中，我們談到了開始有針對性地推出 Mydcombi 的努力，以及與其他公司合作利用和貨幣化 Optejet 技術的目標，而不僅僅是我們自己的開發項目。

Today, we will provide an update for both of these topics, starting with Mydcombi and our recent first commercial sale. As you'll recall in May, we received FDA approval of Mydcombi, the first and only fixed combination of tropicamide and phenylephrine and the only ophthalmic spray for inducing mydriasis for diagnostic procedures and then (technical difficulty) where short-term pupil dilation is desired. We are proud to have delivered the first FDA-approved product that leverages our Optejet dispensing device. This important advancement was featured at the annual OCTANE Ophthalmology Tech Forum in June, where we highlighted the innovative nature of Mydcombi and the future of the Optejet technology to the ophthalmic community, including potential industry partners, thought leaders and investors.

今天，我們將為這兩個主題提供更新，從 Mydcombi 和我們最近的首次商業銷售開始。您可能還記得，今年 5 月份，我們獲得了 FDA 對 Mydcombi 的批准，這是第一個也是唯一一個托品酰胺和苯腎上腺素的固定組合，也是唯一一種用於在診斷程序中誘導瞳孔散大，然後（技術難度）在需要短期瞳孔擴張的情況下使用的眼科噴霧劑。我們很榮幸能夠交付第一款利用我們的 Optejet 分配裝置的 FDA 核准產品。這項重要進展在 6 月的 OCTANE 眼科技術年度論壇上進行了展示，我們在會上向眼科界（包括潛在的行業合作夥伴、思想領袖和投資者）強調了 Mydcombi 的創新性和 Optejet 技術的未來。

We're thrilled to have initiated sales of Mydcombi to a targeted group of professional offices. Ophthalmologists, optometrists, technicians and patients are now experiencing the benefits of Mydcombi themselves, and together, we are learning how the product can streamline practices and help with patient management. As we announced last week upon receipt of our New York pharmacy license, we achieved our first commercial sale of Mydcombi to world-renowned, board-certified ophthalmologist, Dr. Nathan Radcliffe, who becomes first to incorporate Mydcombi into his daily practice.

我們非常高興能夠向目標專業辦公室群體開始銷售 Mydcombi。眼科醫生、驗光師、技術人員和患者現在都親身體驗了 Mydcombi 的好處，我們一起學習該產品如何簡化實踐並幫助患者管理。正如我們上週在紐約藥劑師執照後宣布的那樣，我們首次向世界知名、委員會認證的眼科醫生 Nathan Radcliffe 博士實現了 Mydcombi 的商業銷售，他成為第一個將 Mydcombi 納入其日常實踐中的人。

Last week, we conducted training at OC Retina in Orange [County], California and as soon as our California pharmacy license is received, we anticipate initiating sales in this state. We are already receiving positive feedback from doctors, technicians and patients, and we anticipate this will only increase with additional sales and marketing ramp-up. To that end, we are in the process of formally adding additional commercial manufacturing sites to support Mydcombi, including our Redwood City facility as well as Coastline manufacturing as a secondary site. Bren will provide additional details during his manufacturing overview.

上週，我們在加州橘郡的 OC Retina 進行了培訓，一旦我們獲得加州的藥品經營許可證，我們預計就會在該州開始銷售。我們已經收到來自醫生、技術人員和患者的正面回饋，我們預計，隨著銷售和行銷的擴大，這種回饋還會增加。為此，我們正在正式增加額外的商業製造基地來支持 Mydcombi，包括我們的紅木城工廠以及作為二級基地的海岸線製造基地。布倫將在他的製造概述中提供更多細節。

These additional sites will provide us with increased capacity to meet and anticipate demand not only of Mydcombi, but potential future ophthalmic therapies utilizing the Optejet. If you would like to find out more about Mydcombi, track our launch progress and hear what doctors and patients are saying about the product, you can go to the website at mydcombi.com.

這些額外的站點將為我們提供更大的產能，以滿足和預測不僅是 Mydcombi 的需求，而且還能滿足和預測未來利用 Optejet 的潛在眼科治療的需求。如果您想了解有關 Mydcombi 的更多資訊、追蹤我們的發布進度以及聽取醫生和患者對該產品的評價，您可以訪問網站 mydcombi.com。

Now I'd like to talk a bit more about our efforts to leverage and monetize the Optejet technology through partnerships with other companies. We have engaged in active discussions in this area with no fewer than 4 companies across a variety of topical ophthalmic markets. Some of these discussions take longer than would be assumed because we need to first determine if the products under discussion are compatible with the Optejet. This is something that is true for any container closure system. And usually, those tests include both spray performance as well as material compatibility. We anticipate being able to announce the first of these arrangements very shortly. Our goal with all of these discussions is to marry our leading delivery technology with a new or unique drug asset to bring the best of both worlds to patients and prescribers, while providing near-term revenue and/or capital opportunities for the company.

現在，我想進一步談談我們透過與其他公司合作來利用和貨幣化 Optejet 技術的努力。我們已經與多個局部眼科市場的不少於 4 家公司就該領域進行了積極的討論。有些討論花費的時間比預想的要長，因為我們需要先確定討論的產品是否與 Optejet 相容。對於任何容器封閉系統來說，這都是正確的。通常，這些測試包括噴塗性能以及材料相容性。我們預計很快就能宣布其中第一個安排。我們進行所有這些討論的目標是將我們領先的遞送技術與新的或獨特的藥物資產結合起來，為患者和處方者帶來兩全其美的服務，同時為公司提供近期收入和/或資本機會。

I'll now provide an update on Apersure, our intended brand-name for the MicroLine project. Apersure is a proprietary topical on-demand pilocarpine-based therapeutic candidate that we are developing for the temporary improvement in near vision associated with presbyopia. As you may know, presbyopia is the age-related hardening of the eyes' lens causing blurred near vision. This addressable market represents over 18 million people in the United States alone between the ages of 40 and 55, who otherwise never wore glasses and have the resources for a cash pay product. Our proprietary market research suggests this could be nearly $1 billion annual market in the U.S. alone.

我現在將提供有關 Apersure 的最新信息，這是我們為 MicroLine 專案計劃使用的品牌名稱。 Apersure 是我們開發的一種專有的局部按需毛果芸香鹼類候選治療藥物，用於暫時改善老花眼相關的近距離視力。您可能知道，老花眼是由於年齡相關原因導致的眼睛水晶體變硬，從而造成近距離視力模糊。這個潛在市場僅在美國就代表著 1800 多萬年齡在 40 至 55 歲之間的人，他們原本從未戴過眼鏡，並且有能力購買現金支付產品。我們的專有市場研究表明，僅在美國，這一市場每年的規模可能接近 10 億美元。

As we discussed last quarter, we received feedback from the FDA, outlining a clear path forward for this program towards a new drug application, or NDA, and we continue to make progress on this front. Apersure is being designed for use with our more advanced Gen 2 Optejet device, which has been optimized for in-home use. These will be manufactured in our Redwood City facility, and we anticipate that manufacturing of registration batches will commence in the fourth quarter of this year. Based on the FDA requirement of 12 months of real-time stability data on the final packaged product before filing an NDA, we plan to file the NDA approximately 12 months after we run those batches to late 2024.

正如我們上個季度所討論的那樣，我們收到了 FDA 的反饋，為該計劃邁向新藥申請（NDA）指明了明確的方向，並且我們在這方面繼續取得進展。 Apersure 專為與我們更先進的 Gen 2 Optejet 設備配合使用而設計，該設備已針對家庭使用進行了優化。這些產品將在我們位於雷德伍德城的工廠生產，我們預計註冊批次的生產將於今年第四季開始。根據 FDA 在提交 NDA 之前對最終包裝產品提供 12 個月的即時穩定性數據的要求，我們計劃在 2024 年底之前運行這些批次後約 12 個月提交 NDA。

Apersure differs from the current topical drug treatment option for presbyopia on the market and those in development, and that was a drug-device combination. As such, many optometrists would be able to include Apersure as an offering to patients along with eyeglasses. Apersure has been described by some in market research as a second pair of invisible glasses or the way the game (technical difficulty) vision for those times when wearing glasses is not desirable. We tested this concept with 100 optometrists, who found that Apersure would meet the needs of both themselves and their patients better than any other pharmaceutical option that they have or believe will have available.

Apersure 不同於目前市場上和正在研發的老花眼局部藥物治療方案，它是一種藥物與設備的結合。因此，許多驗光師能夠將 Apersure 與眼鏡一起提供給患者。一些市場調查人員將 Apersure 描述為第二副隱形眼鏡，或在不適合戴眼鏡的情況下提供遊戲（技術難度）視覺的方式。我們與 100 名驗光師一起測試了這個概念，他們發現 Apersure 比他們擁有的或認為將擁有的任何其他藥物選擇更能滿足他們自己和患者的需求。

These doctors estimated that Apersure ophthalmic spray could capture as much as 1/3 of the presbyopia pharmaceutical market, with the other 5 products, all eye drops, competing for the remaining 2/3 of that market. If approved, we believe that Apersure administered using the Optejet, will stand out as the one and only spray distinguished by its ergonomic design, ease of use and potentially [as it changes] side effect profile.

這些醫生估計，Apersure 眼科噴霧劑可以佔據老花眼藥品市場的 1/3，而其他 5 種產品（都是眼藥水）則爭奪剩餘的 2/3 市場。如果獲得批准，我們相信使用 Optejet 施用的 persure 將脫穎而出，成為唯一一款具有人體工學設計、易於使用且潛在（隨著其變化）副作用特徵的噴霧劑。

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. As Michael mentioned, we continue to expeditiously build out our manufacturing capabilities in support of Mydcombi and registration batches for Apersure. To expand upon the Mydcombi-targeted launch, we have filed with the FDA a request to approve the use of an additional manufacturing site, Coastline International. The FDA has given us a PDUFA date of mid-November 2023 for the site to be approved for use. Coastline has already been manufacturing clinical supply for us for over a year and has extensive experience with the Optejet. Following the PDUFA, we anticipate to be a smooth ramp-up, and the team at Coastline is eager to support our commercial manufacturing needs.

謝謝你，麥可。正如邁克爾所提到的，我們將繼續迅速擴大我們的製造能力，以支持 Mydcombi 和 Apersure 的註冊批次。為了擴大針對 Mydcombi 的發布，我們已向 FDA 提交了請求，希望批准使用額外的生產基地 Coastline International。 FDA 已為我們提供了 2023 年 11 月中旬該場地的 PDUFA 批准使用日期。 Coastline 已為我們生產臨床用品一年多了，在 Optejet 方面擁有豐富的經驗。按照 PDUFA 的規定，我們預計將順利實現成長，而 Coastline 的團隊也渴望支持我們的商業製造需求。

We also submitted our Redwood City facility to the FDA as an additional manufacturing site and anticipate hearing from the FDA soon without PDUFA dates. Our Redwood City facility has made significant progress in qualifying our Gen 2 fill-and-finish line. The team is scheduled to begin media fills this month, a monumental step in qualifying this production equipment to support Apersure and the remainder of the Eyenovia drug product lines. As Michael mentioned, we are targeting the initiation of Apersure registration batches in the fourth quarter of 2023. Additionally, our Reno facility continues to make significant progress in establishing base and ejector manufacturing.

我們也將紅木城工廠向 FDA 提交了申請，作為額外的生產基地，預計 FDA 很快就會公佈相關消息，但不提供 PDUFA 日期。我們的雷德伍德城工廠在第二代灌裝和精加工生產線的認證方面取得了重大進展。該團隊計劃於本月開始進行培養基填充，這是使該生產設備能夠支援 Apersure 和其餘 Eyenovia 藥品系列的重要一步。正如麥可所說，我們的目標是在 2023 年第四季啟動 Apersure 註冊批次。

On our last earnings call, we noted that the facility construction had been completed and the staff has taken occupancy. Since then, production equipment has been received, installation of the equipment is currently underway and qualification activities are in the final planning stages. I continue to be excited about the progress we've made to enhance our manufacturing. With an increased manufacturing capacity, we'll be better positioned to meet the anticipated growth demand of Optejet, particularly with the approval and commercial availability of Mydcombi.

在我們上次的收益電話會議上，我們注意到設施建設已經完成，工作人員已經入住。自那時起，生產設備已經收到，設備安裝目前正在進行中，資格認證活動正處於最後的規劃階段。我對我們提高製造業所取得的進展繼續感到興奮。隨著生產能力的提高，我們將能夠更好地滿足 Optejet 預期的成長需求，尤其是隨著 Mydcombi 的批准和商業化應用。

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？

Thanks, Bren. For the second quarter of 2023, net loss was approximately $6.2 million or $0.16 per share compared to a net loss of approximately $7.2 million or $0.22 per share for the second quarter of 2022. Research and development expenses totaled approximately $2.8 million for the second quarter of 2023 as compared to $3.6 million for the second quarter of 2022. For the second quarter of 2023, G&A expenses were approximately $3.1 million compared to $3.5 million for the second quarter of 2022.

謝謝，布倫。 2023 年第二季度，淨虧損約為 620 萬美元或每股 0.16 美元，而 2022 年第二季度的淨虧損約為 720 萬美元或每股 0.22 美元。 2 年第二季為 350 萬美元。

Total operating expenses for the second quarter of 2023 were approximately $6 million compared to $7.1 million for the second quarter of 2022. As of June 30, 2023, company's cash and cash equivalents were approximately $17.5 million compared to $22.9 million as of December 31, 2022. This includes an additional $5 million drawdown on our credit line with Avenue Capital that was triggered by the FDA approval of Mydcombi.

2023 年第二季的總營運費用約為 600 萬美元，而 2022 年第二季為 710 萬美元。 00 萬美元。

For a brief update on our licensing revenues, in addition to the cash balance noted above, we have receivables from our license partners of approximately $430,000 as of June 30, 2023, and expect a reimbursement payment of approximately $2 million from Arctic Vision for product development expenses in the second half of 2023.

簡要介紹我們的授權收入，除了上述的現金餘額外，截至 2023 年 6 月 30 日，我們從授權合作夥伴處獲得的應收款項約為 43 萬美元，並預計 Arctic Vision 將在 2023 年下半年為產品開發費用報銷約 200 萬美元。

I'll now update -- I'll now provide an update on our existing licensing programs with Bausch Health for MicroPine in the U.S. and Canada and Arctic Vision for all 3 of our products in China and South Korea. Bausch + Lomb is continuing to enroll in the ongoing Phase III CHAPERONE trial of MicroPine, a proprietary atropine formulation for the reduction of pediatric myopia progression. It has been shown in clinical studies to slow myopia progression by 60% or more. There are currently no FDA-approved drug therapy for this indication, and if left untreated, this can result in retinal detachment, myopic retinopathy as well as vision loss.

我現在將更新——我現在將提供有關我們現有的許可計劃的最新信息，即我們與 Bausch Health 在美國和加拿大就 MicroPine 達成的許可計劃，以及與 Arctic Vision 在中國和韓國就我們所有 3 種產品達成的許可計劃。博士倫正持續參與 MicroPine 的 III 期 CHAPERONE 試驗，MicroPine 是一種用於減緩兒童近視進展的專有阿托品製劑。臨床研究表明，它可以將近視的發展減緩60％或更多。目前尚無 FDA 批准用於治療該病症的藥物，如果不及時治療，可能會導致視網膜脫落、近視視網膜病變以及視力喪失。

Our agreement with Arctic Vision covers Greater China and South Korea and 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 significant source of non-dilutive funding for our company over the long term.

我們與 Arctic Vision 的協議涵蓋大中華區和韓國，涵蓋 MicroPine、MicroLine 和 Mydcombi，並為我們提供開發里程碑以外的銷售版稅。 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 將成為我們公司長期重要的非稀釋性資金來源。

To date, our license agreements have generated approximately $16 million in license fees with the potential to earn an additional $60 million in net license and development milestones as well as reimbursable expenses over the next 4 years. Upon commercialization, if our products are approved, Eyenovia is also eligible to earn significant sales royalties. We are also 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.

迄今為止，我們的授權協議已產生了約 1,600 萬美元的授權費，並有可能在未來 4 年內額外獲得 6,000 萬美元的淨許可和開發里程碑以及可報銷費用。如果我們的產品商業化後獲得批准，Eyenovia 還可以獲得可觀的銷售特許權使用費。我們也正在繼續評估與 Formosa 協議類似的潛在管道擴展機會，並將繼續利用 Optejet 技術來滿足未滿足的需求和其他大型眼科適應症。

Finally, Eyenovia was added to the small-cap Russell 2000 and broad market Russell 3000 indices effective in June as part of the annual Russell Indexes reconstitution. The reconstitution captures the 4,000 largest U.S. stocks as of April 28, 2023, ranked by total market capitalization.

最後，作為年度羅素指數重組的一部分，Eyenovia 於 6 月被添加到小型股羅素 2000 指數和大盤羅素 3000 指數中。此次重組涵蓋了截至 2023 年 4 月 28 日的 4,000 隻美國最大股票，按總市值排序。

So in conclusion, we are very pleased with our performance through the first half of 2023. To summarize some of the key highlights. We received FDA approval of Mydcombi and initiated sales to select professional offices. Registration batches for Apersure presbyopia program are expected to initiate in the fourth quarter of 2023. We continue to advance discussions with multiple potential partners to leverage the Optejet and additional ophthalmic indications.

總而言之，我們對 2023 年上半年的表現非常滿意。我們獲得了 FDA 對 Mydcombi 的批准，並開始向選定的專業辦公室銷售。 Apersure 老花眼計畫的註冊批次預計將於 2023 年第四季開始。

We're continuing to build out our manufacturing capabilities, with Coastline manufacturing and our Redwood City facilities anticipated to come to support Mydcombi production in late 2023 and early 2024, respectively. And our licensing agreements with Arctic Vision and Bausch + Lomb are progressing well and remain a promising avenue for significant development and regulatory milestones as well as the potential for sales royalties.

我們將繼續增強我們的製造能力，預計海岸線製造工廠和紅木城工廠將分別於 2023 年底和 2024 年初支持 Mydcombi 的生產。我們與 Arctic Vision 和 Bausch + Lomb 的授權協議進展順利，並且仍然是實現重大開發和監管里程碑以及獲得銷售特許權使用費潛力的有希望的途徑。

That concludes our prepared remarks today. We would now like to open the call to questions. Operator?

今天的準備好的發言到此結束。我們現在想開始提問。操作員？

(Operator Instructions) Our first questions come from the line of Matthew Caufield with H.C. Wainwright.

（操作員指示）我們的第一個問題來自 H.C. 的 Matthew Caufield。溫賴特。

Congrats, obviously, on the ongoing Optejet progress this quarter. So first of 2 questions. Regarding development of the Gen 2 device, particularly for on-demand presbyopia, is there a point in the future where all devices will be Gen 2, both prospectively for MicroLine or Apersure as well as for Mydcombi? Just kind of wondering if there's any sort of manufacturing streamlining if all Optejets are based on the Gen 2 design.

顯然，我們要祝賀 Optejet 本季取得的持續進展。所以這是兩個問題中的第一個。關於第二代設備的開發，特別是針對按需老花眼的開發，未來是否會出現所有設備都為第二代的情況，包括 MicroLine 或 Apersure 以及 Mydcombi？只是想知道，如果所有 Optejets 都基於 Gen 2 設計，是否會有任何形式的製造精簡。

Thank you, Matt, for that question. The answer is, ultimately, yes. And the reason we're going from Gen 1 to Gen 2 is not just because Gen 2 ergonomically and aesthetically, we believe, is a nicer product, but it has far fewer parts than the Gen 1 does. So while the system that you use to spray is identical, the parts within the Gen 2 make it a lot easier and simpler and less costly to actually build. So in the long term, we do want to get everything onto that platform.

謝謝馬特提出這個問題。答案最終是肯定的。我們之所以從第一代升級到第二代，不僅是因為我們認為第二代在人體工學和美學方面是一款更優秀的產品，而且它的零件數量也比第一代少得多。因此，雖然您使用的噴塗系統相同，但 Gen 2 中的零件使實際建造變得更加容易、簡單且成本更低。所以從長遠來看，我們確實希望將所有內容都放到該平台上。

Got it. Very helpful. And then just one kind of follow-up on the presbyopia progress. So have the Generation 2 studies for microbial challenge, human factor, electronic safety and any drug stability data, have those all been completed? Or are any of those efforts kind of still ongoing presently?

知道了。非常有幫助。然後只是對老花眼進展的一種追蹤。那麼第二代微生物挑戰、人為因素、電子安全和任何藥物穩定性數據的研究都完成了嗎？或者這些努力目前仍在進行中？

Some of those are completed. Some are ongoing, but they will all be done probably by the end of this year. So they're not a rate-limiting step and there's nothing in there that causes us any pause because a lot of this is very similar to what we did with the Gen 1. So really the rate-limiting step is the 12-month stability.

其中一些已經完成。有些工作正在進行中，但可能將在今年年底全部完成。因此，它們不是限速步驟，而且其中沒有任何內容會讓我們暫停，因為其中許多內容與我們在第一代上所做的非常相似。

Our next questions come from the line of Matt Kaplan with Ladenburg Thalmann.

我們的下一個問題來自 Ladenburg Thalmann 的 Matt Kaplan。

This is Raymond in for Matt. Congrats on all the progress. I'm glad to see Mydcombi being used. I guess relating to that, I was wondering, how should we think about kind of the state of the launches as it progresses in terms of licenses, uptake and so forth? I have a follow-up.

這是雷蒙德 (Raymond)，取代馬特 (Matt)。恭喜你所取得的所有進步。我很高興看到Mydcombi被使用。我想與此相關，我想知道，我們應該如何看待在許可證、吸收等方面的進展？我有一個後續問題。

John, do you want to take this or I can? It's up to you.

約翰，你想拿這個還是我拿？由你決定。

No, it's okay. So I think that the -- with respect to Mydcombi, we're focusing initially, as Michael mentioned, on a targeted launch program. We feel that with the Coastline manufacturing coming up towards the end of this year, we'll be able to give better visibility to the investor community as to guidance of Mydcombi once we have that in place.

不，沒關係。因此我認為——就 Mydcombi 而言，正如邁克爾所提到的，我們最初關注的是針對性的發布計劃。我們認為，隨著 Coastline 製造計畫在今年年底前啟動，一旦我們制定了 Mydcombi 指導方針，我們將能夠為投資者群體提供更好的透明度。

So we expect probably with that third quarter earnings call, which will be in November, we'll be able to give guidance for obviously 2024, probably beyond as well. With respect to licenses or partnership opportunities, they remain a key focus of ours. Michael highlighted that we're speaking to no less than 4 parties at this time. So that continues to be a major focus for the company.

因此，我們預計，在 11 月的第三季財報電話會議上，我們將能夠提供 2024 年甚至更遠時期的指引。對於許可或合作機會，它們仍然是我們關注的重點。麥可強調說，我們目前正在與不少於 4 方進行交談。因此，這仍然是公司的重點。

Okay. Yes. No, definitely. I appreciate that color. I guess I was wondering, are there any early feedback you're getting? And are you -- do you see how you would like to incorporate that as you are getting ready for a national launch next year?

好的。是的。不，當然。我很欣賞那個顏色。我想知道您是否收到了任何早期回饋？而且您是否—在您準備明年在全國範圍內推出產品時，您是否想過如何將其融入其中？

Yes. It's funny that you asked this question because we just were speaking with some of the technicians at one of the offices in New York. They've now used the product for a week. And what they're finding out is they started by using it on a few patients. They told us today, they used it on every patient, 40 patients they dilated today. And the more they use it, the more they like it.

是的。你問這個問題很有趣，因為我們剛剛與紐約一個辦事處的一些技術人員進行了交談。他們現在已經使用該產品一周了。他們開始在一些病人身上使用它來發現它。他們今天告訴我們，他們對每個病人都使用了它，今天他們擴張了 40 個病人。他們用得越多，就越喜歡它。

What they're also finding is that the duration of dilation is less than it is with eye drops, which is actually a positive because one of the reasons people don't like to get dilated is they end up being dilated for hours and hours and hours, through the rest of the day. And it's looking like, with Mydcombi, you get the efficacy that you need, and then it may very well not last as long, which is a positive if you get back to normal. So we're definitely looking into that some more.

他們還發現，與眼藥水相比，瞳孔散大的持續時間較短，這實際上是一個優點，因為人們不喜歡瞳孔散大的其中一個原因是，他們最終會在一天的剩餘時間裡連續幾個小時保持瞳孔散大。而且看起來，使用 Mydcombi，您可以獲得所需的療效，而且它可能不會持續太長時間，但如果您恢復正常，這是積極的。所以我們肯定會對此進行進一步調查。

I'm showing no further questions at this time. I'd like to hand the floor back to management for any closing comments.

我目前沒有其他問題。我想將發言權交還給管理階層，以便他們發表最後評論。

Thank you, and thanks, everybody, for joining us today, and that concludes today's call. We are very pleased with the year we have had so far. We've had our first FDA approval and commercial sale of Mydcombi. Our Apersure presbyopia program is progressing, and our manufacturing capabilities are continuing to grow. We look forward to continued [momentum] through the rest of 2023 and beyond. Thank you again for joining us. We look forward to the third quarter update in (technical difficulty).

謝謝大家今天的參與，今天的電話會議到此結束。我們對今年迄今取得的成績感到非常滿意。我們已經獲得了 Mydcombi 的首個 FDA 批准和商業銷售。我們的Apersure老花眼計畫正在取得進展，我們的製造能力也不斷增強。我們期待在 2023 年剩餘時間及以後繼續保持這種勢頭。再次感謝您的加入我們。我們期待第三季的更新（技術難度）。

Thank you. This does conclude today's teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day.

謝謝。今天的電話會議到此結束。我們感謝您的參與。現在您可以斷開您的線路。祝你剩餘的時光愉快。