IVERIC bio Inc (ISEE) 2022 Q4 法說會逐字稿

Good morning and welcome to the IVERIC bio Fourth Quarter 2022 Earnings Conference Call. (Operator Instructions) Please note, this event is being recorded.

早上好，歡迎參加 IVERIC bio 2022 年第四季財報電話會議。 （操作員指示）請注意，此活動正在錄製中。

I would now like to turn the conference over to Kathy Galante, Investor Relations. Please go ahead.

現在我想把會議交給投資者關係部門的Kathy Galante。請繼續。

Good morning and welcome to the IVERIC bio conference call. Representing IVERIC bio today are Glenn Sblendorio, Chief Executive Officer; Dr. Pravin Dugel, President; Keith Westby, Chief Operating Officer; David Carroll, Chief Financial Officer; Dr. Dhaval Desai, Chief Development Officer; Chris Simms, Chief Commercial Officer and Tony Gibney, Chief Business and Strategy Officer.

早上好，歡迎參加IVERIC bio電話會議。今天代表IVERIC bio出席的嘉賓包括：首席執行官Glenn Sblendorio、總裁Pravin Dugel博士、首席營運官Keith Westby、首席財務官David Carroll、首席開發官Dhaval Desai博士、首席商務官Chris Simms以及首席業務和戰略官Tony Gibney。

I would like to remind you that today we will be making statements relating to IVERIC bio's future expectations regarding operational, financial and research and development matters. These statements constitute forward-looking statements for the purposes of the safe harbor provision under the Private Securities Litigation Reform Act of 1995. These statements cover many events and materials that are subject to various risks that could cause actual results to differ materially from those expressed or implied by any forward-looking statement.

我想提醒您，今天我們將就IVERIC bio在營運、財務和研發方面的未來預期做出聲明。這些聲明構成1995年《私人證券訴訟改革法》安全港條款所指的前瞻性聲明。這些聲明涵蓋許多事件和資料，這些事件和資料受各種風險影響，可能導致實際結果與任何前瞻性聲明中明示或暗示的結果有重大差異。

I refer you to our SEC filings and in particular to the risk factors included in our quarterly report on Form 10-Q filed on November 4th, 2022, for a detailed description of the risk factor affecting our business that could cause actual results or events to differ materially from the forward-looking statements that we make. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we disclaim any obligation to do so, except as required by law.

請您參閱我們提交給美國證券交易委員會 (SEC) 的文件，特別是我們於 2022 年 11 月 4 日提交的 10-Q 表季度報告中包含的風險因素，以詳細了解影響我們業務的風險因素，這些因素可能導致實際結果或事件與我們做出的前瞻性陳述存在重大差異。此外，任何前瞻性陳述僅代表我們截至今日的觀點，不應被視為代表我們在任何後續日期的觀點。雖然我們可能選擇在未來某個時間點更新這些前瞻性陳述，但我們不承擔任何此類更新的義務，除非法律另有規定。

I would now like to turn the call over to Glenn.

現在我想把電話轉給格倫。

Well, thanks, Kathy and good morning everybody. In 2022, we continued to deliver on our goal to deliver -- to provide potential treatments to patients suffering from retinal diseases with avacincaptad pegol or ACP, achieving a statistically significant reduction in the rate of geographic atrophy progression, at the 12-month prespecified primary endpoints across two Phase 3 clinical trials.

好的，謝謝凱西，大家早安。 2022年，我們繼續履行我們的目標——為患有視網膜疾病的患者提供阿伐那普利或ACP的潛在治療方案，在兩項3期臨床試驗的12個月預設主要終點中，實現了地理性萎縮進展速度的顯著降低，且具有統計學意義。

We began 2023 with the FDA's acceptance of the filing of our new drug application for ACP, for the treatment of geographic atrophy, or GA secondary to age-related macular degeneration. With the achievement of this important milestone, we moved closer to our goal of providing patients with a treatment for GA, a devastating disease that leads to irreversible blindness. Additionally, our NDA has been granted priority review by the FDA and given a Prescription Drug User Fee Act or PDUFA date of August 19, 2023.

2023年伊始，FDA接受了我們用於治療年齡相關性黃斑部病變（ACP）的新藥申請，該藥物用於治療繼發於年齡相關性黃斑部病變的地圖樣萎縮（GA）。隨著這一重要里程碑的達成，我們距離為患者提供治療GA（一種會導致不可逆失明的毀滅性疾病）的目標又近了一步。此外，我們的新藥申請（NDA）已獲得FDA的優先審查，並獲得了處方藥用戶付費法案（PDUFA）的批准日期，即2023年8月19日。

We are also informed that at the time of the FDA acceptance letter, the FDA had not identified any potential review issues and the FDA was not currently planning to hold an advisory committee meeting for ACP. This morning, we announced results of a post-hoc analysis on the data from the ACP GATHER1 and GATHER2 clinical trials, signaling in up to 59% risk reduction in the rate of vision loss for the ACP 2 milligram groups compared to Sham at 12 months of treatment.

我們也獲悉，在FDA發出受理函時，FDA尚未發現任何潛在的審查問題，且目前沒有計劃為ACP召開諮詢委員會會議。今天上午，我們公佈了ACP GATHER1和GATHER2臨床試驗數據的事後分析結果，結果顯示，與假手術組相比，ACP 2毫克組在12個月的治療中，視力喪失風險降低了高達59%。

Pravin will discuss this new data in more details in a few moments. As we move closer to potential approval, our key focus in 2023 is to make ACP commercially available to physicians and their patients suffering with GA as quickly as possible. But a year ago, we started to build a world-class commercial team that include sales leadership, reimbursement, marketing and market access. Our commercial leadership team brings extensive experience in launching drugs for retinal diseases in large markets.

Pravin 稍後將更詳細地討論這些新數據。隨著我們距離潛在批准越來越近，我們在 2023 年的重點是盡快將 ACP 推向市場，供患有 GA 的醫生及其患者使用。但一年前，我們就開始組建一支世界一流的商業團隊，其中包括銷售領導、報銷、行銷和市場准入。我們的商業領導團隊在大型市場推出視網膜疾病藥物方面擁有豐富的經驗。

We continue to accelerate our launch plans and expect to have a full U.S. team, including a field-based sales team hired by early April of this year. Our commercial team, which is led by Chris Simms expects to have a field force of approximately 50 to 70 sales representatives and an organization of about 120 in total.

我們將繼續加快產品上市計劃，預計今年4月初將組成完整的美國團隊，其中包括駐地銷售團隊。我們的商業團隊由Chris Simms領導，預計將擁有約50至70名銷售代表組成的駐地團隊，公司總規模約為120人。

Since this is our year-end call, I wanted to reflect back on some of the significant accomplishments of 2022. We received top line data from GATHER2 in early September and finished our rolling submission of the NDA for ACP in late December. This was done in just over a little -- just over three months. In November '22, we announced the FDA granted Breakthrough Therapy designation for ACP for the treatment of GA secondary to AMD.

由於這是我們的年終電話會議，我想回顧2022年取得的一些重大成就。我們在9月初收到了GATHER2的頂線數據，並在12月底完成了ACP新藥申請的滾動提交。這一切只花了短短三個多月的時間。 2022年11月，我們宣布FDA授予ACP突破性療法認定，用於治療繼發於AMD的GA。

To date, ACP is the first and only investigational drug to receive breakthrough therapy status for this indication, which was granted based on the 12-month results from both GATHER1 and GATHER2. We also intend to pursue further discussions with the FDA about utilizing the GATHER1 and GATHER2 clinical trial data included in the current NDA submission to support treatment of GA associated with earlier stage disease, including patients with intermediate AMD.

迄今為止，ACP 是第一個也是唯一一個獲得此適應症突破性療法認定的在研藥物，該認定基於 GATHER1 和 GATHER2 的 12 個月結果。我們也計劃與 FDA 進一步探討如何利用目前 NDA 申請中包含的 GATHER1 和 GATHER2 臨床試驗數據，支持治療早期疾病相關的 GA，包括中期 AMD 患者。

We do not plan to conduct a new clinical trial of ACP in patients with intermediate AMD. We initiated an open-label extension study for patients who have completed their month 24 visit in the GATHER2 clinical trial, with the aim of providing patients long-term access to ACP and collecting additional safety data. And we continue to invest in additional life cycle initiatives for ACP to expand the patient population and evaluate multiple sustained delivery technologies for ACP.

我們不計劃針對中期AMD患者進行新的ACP臨床試驗。我們已啟動一項開放標籤擴展研究，針對已完成GATHER2臨床試驗第24個月追蹤的患者，旨在為患者提供長期ACP治療機會並收集更多安全性數據。我們將繼續投資ACP的更多生命週期項目，以擴大患者群體並評估多種ACP持續給藥技術。

On the financial front, in December of 2022, we raised approximately $324.3 million in net proceeds, in an underwritten public offering of our common stock. Also in 2022, we secured a term loan credit facility, providing us with up to $250 million in non-dilutive debt financing under which we have drawn down $100 million to date. These financings further strengthen our balance sheet and provide financial flexibility as we continue to build our U.S. launch readiness plan and prepare for the potential commercialization of ACP. Dave is going to provide some more details on our cash position in a moment.

在財務方面，2022年12月，我們透過承銷公開發行普通股籌集了約3.243億美元的淨收益。此外，在2022年，我們獲得了一筆定期貸款信貸額度，為我們提供高達2.5億美元的非稀釋性債務融資，迄今為止我們已提取了1億美元。這些融資進一步增強了我們的資產負債表，並提供了財務靈活性，因為我們將繼續制定美國發射準備計劃，並為ACP的潛在商業化做好準備。 Dave稍後將提供有關我們現金狀況的更多詳細資訊。

I also want to acknowledge Pravin's election to the Board of Directors at the beginning of this year. Pravin has been instrumental in helping to shape the company's business strategy and in overseeing the development and regulatory strategy for ACP. Pravin is truly a person to work with you and I look forward to our continued work together.

我還要感謝Pravin在今年初當選董事會成員。 Pravin在協助制定公司業務策略以及監督ACP的發展和監管策略方面發揮了重要作用。 Pravin是一位真正值得與您共事的人，我期待我們繼續合作。

Before I turn the call over to Pravin, on behalf of IVERIC bio, we want to take a moment to congratulate Apellis for their approval of SYFOVRE, which finally provides patients with the first treatment for GA. We also want to commend the FDA for their ongoing commitment to finding treatments for patients suffering from AMD. I want to thank all of you for your continued support of IVERIC bio and I will now turn the call over to Pravin.

在將電話轉給 Pravin 之前，我謹代表 IVERIC bio 公司，祝賀 Apellis 公司批准 SYFOVRE，這終於為患者提供了首個治療 GA 的藥物。我們也要讚揚 FDA 持續致力於為 AMD 患者尋找治療方法。感謝大家對 IVERIC bio 的持續支持，現在我將電話轉給 Pravin。

Thank you, Glenn and good morning, everyone. I could not agree more with you, Glenn, a big congratulations to our friends at Apellis. Our plans to drive ACP to a potential approval in GA has been clear and consistent throughout this journey. We believe our special protocol assessment for GATHER2, fast track and rolling review of our NDA, breakthrough therapy designation and now priority review further strengthens our position as we get closer to a potential near-term launch of ACP for GA patients.

謝謝格倫，大家早安。格倫，我完全同意你的觀點，也祝賀我們在Apellis的朋友。我們推動ACP在GA獲批的計畫始終清晰明確，始終如一。我們相信，隨著ACP在GA患者群體中的潛在上市，我們對GATHER2的特殊方案評估、NDA的快速通道和滾動審查、突破性療法認定以及現在的優先審查，這些都將進一步鞏固我們的地位。

We look forward to collaborating with the FDA throughout the remaining NDA review process. We are excited to announce a post-talk time-to-event analysis of the data from the GATHER1 and GATHER2 trials that signaled a reduction in the rate of vision loss for the ACP 2 milligram groups compared to Sham after 12 months of treatment. In this analysis, we define vision losses greater than or equal to 15 letter loss in best corrected visual acuity or BCVA from baseline measured at any two consecutive visits. These results were consistent in the GATHER1 and GATHER2 clinical trials when analyzed independently, which signaled a 44% reduction with a hazard ratio of 0.56 and a 59% reduction with a hazard ratio of 0.41 respectively and the rate of vision loss for the ACP 2-milligram groups compared to Sham after 12 months of treatment.

我們期待在剩餘的 NDA 審查過程中與 FDA 保持合作。我們很高興地宣布，對 GATHER1 和 GATHER2 試驗數據進行的會談後事件發生時間分析表明，與假手術組相比，ACP 2 毫克組在治療 12 個月後視力喪失率有所降低。在該分析中，我們將視力喪失定義為在任何連續兩次就診時測量的最佳矯正視力或 BCVA 相對於基線下降至少 15 個字母。在 GATHER1 和 GATHER2 臨床試驗中，這些結果在獨立分析時保持一致，顯示與假手術組相比，ACP 2 毫克組在治療 12 個月後視力喪失率分別降低了 44%（風險比為 0.56）和 59%（風險比為 0.41）。

In the combined analysis of GATHER1 and GATHER2 patients in the ACP 2-milligram groups experienced a 56% reduction with a hazard ratio of 0.44 in the rate of vision loss compared to Sham after 12 months of treatment. This post-hoc analysis evaluates the potential vision loss signal through 12 months of treatment and is an exploratory analysis in nature.

在GATHER1和GATHER2的綜合分析中，與假手術組相比，ACP 2毫克組患者在治療12個月後視力喪失率降低了56%，風險比為0.44。這項事後分析評估了12個月治療期間潛在的視力喪失訊號，本質上是一項探索性分析。

On average, it takes only 2.5 years for GA lesions to start impacting central vision. It is encouraging to see vision loss reduction data at early time intervals in the first 12 months, which further supports the statistically significant GATHER1 and GATHER2 primary endpoint. This time-to-event analysis will be presented at ARVO in April. We believe this is the first time a reduction in the risk of vision loss will be presented for a potential treatment being investigated for GA.

平均而言，GA病變僅需2.5年即可開始影響中心視力。令人鼓舞的是，在最初12個月的早期時間間隔內，視力喪失的減少數據令人鼓舞，這進一步支持了具有統計意義的GATHER1和GATHER2主要終點。這項事件發生時間分析將於4月在ARVO大會上發表。我們相信，這是首次針對正在研究的GA潛在治療方法，展示其視力喪失風險的降低效果。

With the completion of our NDA submission in December of last year, we have been able to turn our attention to additional analyses of the GATHER program results. We believe the reduction in vision loss data we announce today is important for our planned discussions with European regulators and potential ex U.S. collaborators. Additionally, this timing provides us the opportunity to have the data presented at a major scientific meeting, ARVO in April.

隨著去年12月NDA提交的完成，我們得以將精力轉向對GATHER計畫結果的進一步分析。我們認為，今天公佈的視力喪失數據減少，對於我們計劃與歐洲監管機構以及潛在的前美國合作夥伴進行的討論至關重要。此外，這個時機也為我們提供了機會，讓我們能夠在4月的ARVO大型科學會議上展示這些數據。

Cross GATHER1 and GATHER2 combined, the most common adverse reactions experienced by 5% or more of patients over 12 months in patients who received ACP 2-milligrams was conjunctival hemorrhage, 13%, increased IOP 9%, most of which were transient and resolved within 30 minutes of injection and CNV 7%. In both GATHER1 and GATHER2 in the ACP 2-milligram groups, there were no cases of endophthalmitis, no serious intraocular inflammation events, no vasculitis and no ischemic optic neuropathy events reported through month 12.

綜合 GATHER1 和 GATHER2 治療，接受 ACP 2 毫克治療的患者在 12 個月內最常見的不良反應（發生率 5% 或以上）包括結膜出血（13%）、眼壓升高（9%）（其中大多數為暫時性，注射後 30 分鐘內消退）以及脈絡膜新生血管 (CNV)（7%）。在 ACP 2 毫克組的 GATHER1 和 GATHER2 治療中，截至第 12 個月均未報告眼內炎病例、嚴重眼內發炎事件、血管炎和缺血性視神經病變事件。

We look forward to our PDUFA goal date of August 19, 2023. In the meantime, we will continue to work collaboratively with the FDA on review of our NDA. We believe we are well positioned to become a leader in the development and commercialization of safe and effective treatments for retinal diseases and to create long-term value for our shareholders. We thank you for your time and support and look forward to updating you on our progress going forward.

我們期待2023年8月19日PDUFA目標日期的到來。同時，我們將繼續與FDA合作，審查我們的NDA。我們相信，我們有能力成為安全有效的視網膜疾病治療方案開發和商業化的領導者，並為股東創造長期價值。感謝您的時間和支持，並期待與您分享我們未來的進展。

I will now turn the call over to Dave.

我現在將電話轉給戴夫。

Thank you, Pravin and good morning, everyone. I'd like to highlight a few items from our press release of this morning and provide some guidance on our expected cash runway. For the quarter, our net loss totaled $59.1 million or $0.47 per share, compared to a net loss of $33 million or $0.29 per share for Q4 '21.

謝謝 Pravin，大家早安。我想重點介紹我們今天早上新聞稿中的幾個內容，並就我們預期的現金流提供一些指導。本季度，我們的淨虧損總計 5,910 萬美元，即每股 0.47 美元，而 2021 年第四季的淨虧損為 3,300 萬美元，即每股 0.29 美元。

For the full year, our net loss totaled $185.2 million or $1.53 per share compared to a net loss of $114.5 million or $1.12 per share for 2021. This increase in net loss was driven by increases in both R&D and G&A expenses. R&D expenses increased primarily due to the continued progress of the GATHER2 trial, increased manufacturing activities for ACP and increases in personnel costs associated with additional R&D staffing, including share based compensation.

全年淨虧損總計1.852億美元，即每股1.53美元，而2021年的淨虧損為1.145億美元，即每股1.12美元。淨虧損的增加是由於研發費用和一般及行政費用的增加。研發費用的增加主要由於GATHER2試驗的持續進展、ACP生產活動的增加以及與額外研發人員相關的人員成本（包括股份激勵）的增加。

G&A expenses increased primarily due to increases in commercial launch preparation expenses for ACP and increases in personnel costs associated with additional staffing, including share based compensation.

一般及行政費用增加主要是由於 ACP 商業發布準備費用增加以及與額外人員配備相關的人員成本增加，包括基於股票的薪酬。

Turning to our cash balance and expected cash runway. At December 31st, we had approximately $646.8 million in cash, cash equivalents and available for sale securities. With our successful equity financing and the flexibility provided by our term loan facility with Hercules Capital and Silicon Valley Bank, we believe we have the financial resources required to launch ACP for GA in the U.S., if approved and to meet our planned capital expenditures, debt service obligations and operating expenses for at least the next 12 months. This estimate does not include any potential new borrowings under our term loan facility beyond the $25 million that we plan to borrow in 2023 based on the FDA's acceptance for filing of our NDA.

談到我們的現金餘額和預期現金流。截至12月31日，我們擁有約6.468億美元的現金、現金等價物和可供出售證券。憑藉我們成功的股權融資以及與Hercules Capital和矽谷銀行的定期貸款安排所提供的靈活性，我們相信，如果獲得批准，我們擁有在美國啟動ACP for GA所需的財務資源，並至少在未來12個月內滿足我們計劃的資本支出、償債義務和運營支出。該估計不包括我們根據FDA接受NDA申請後計劃在2023年借入的2500萬美元以外的任何定期貸款安排下的潛在新借款。

Upon the FDA's approval of ACP, we may borrow an additional $75 million from our term loan facility. Thank you for your time. I now turn the call back over to Glenn.

一旦FDA批准ACP，我們可能會從我們的定期貸款機制中再藉入7500萬美元。感謝您抽出時間。現在，我將電話轉回給格倫。

Well, thank you, Dave and thank you, Pravin. Operator, Andrew, if you can open the line for calls -- for questions, please.

好的，謝謝你，戴夫，謝謝你，普拉文。接線生安德魯，請您開通熱線，以便我們解答您的問題。

Yes, sir. (Operator Instructions) The first question comes from Annabel Samimy with Stifel.

是的，先生。 （操作員指示）第一個問題來自 Stifel 的 Annabel Samimy。

Congratulations on the progress, getting to be really exciting and heated. So the vision loss benefit, I guess, is really interesting, I guess, the way it's been phrases that nobody really expected at this early on. So should we view this as a possible functional benefit that you can put in the label? Do they -- will they put post-hoc data or exploratory endpoints in label? Is this something that you can use to sort of, I guess, present yourself competitively to the market? And is there any more tangible functional measurement than that? Like is this like the ultimate functional benefit that you can measure here?

恭喜你們取得的進展，真是令人興奮，也讓人激動不已。所以，我認為視力喪失的益處真的很有趣，因為它一開始就被提及，而這些說法是沒人真正預料到的。那麼，我們是否應該將其視為一種潛在的功能性益處，可以將其標註在標籤上呢？他們會在標籤上標註事後數據或探索性終點嗎？這是否可以用來在市場上展現你們的競爭力？還有比這更實質的功能性衡量指標嗎？這是否是你們可以衡量的最終功能性益處？

Annabel, this is Pravin. Good morning and thank you for your question. In regards to our labeling discussions, look, we are under review currently by the FDA and we obviously don't want to be talking about our discussions with the FDA. So I really have no comment on that whatsoever. The message that I think this post-hoc analysis gives us and again I want to emphasize that this is a post-hoc analysis of a prespecified safety endpoint. And we should look upon this as exploratory data.

安娜貝爾，我是普拉文。早安，感謝您的提問。關於我們的標籤討論，請注意，我們目前正在接受FDA的審查，我們顯然不想談論與FDA的討論。所以我對此真的沒有任何評論。我認為這種事後分析傳達的訊息是，我想再次強調，這是對預設安全終點的事後分析。我們應該將其視為探索性數據。

However, having said that, we also believe that is quite impactful. The message here really is that vision matters and time matters. And let me take each one of them separately. The regulatory agencies have said that ultimately function will follow anatomy and we've looked at a endpoint that involves a slope analysis. And I think what we've been able to show here with this post-hoc analysis is that, that loop may be closed. This is the first time that we've really demonstrated a vision, delta, vision benefit based on the anatomy. So function did actually follow anatomy.

然而，話雖如此，我們也認為這非常有影響力。這裡要傳達的訊息是，願景很重要，時間也很重要。讓我分別談談這兩個方面。監管機構表示，最終功能將遵循解剖結構，我們已經研究了一個涉及斜率分析的終點。我認為，透過這項事後分析，我們能夠證明的是，這個循環可能已經閉合。這是我們第一次真正展示了基於解剖結構的願景、增量和願景效益。所以功能確實遵循了解剖結構。

In terms of time, time does matter. This is not like treating wet AMD, for instance, in wet AMD, you can look -- you can have fluid there. The fluid may be resolved with anti-VEGF usage and function may come back. Here, once the photoreceptor cells die, they don't come back. So the time of onset really does matter. We are very pleased to see that the time of onset was early in this retrospective analysis. So I think at the end of the day, this we consider supportive of our primary endpoint, which is the slope analysis. This is supportive data of the primary endpoint. And again, I think the message here is that vision matters and time matters. And yes, there will be data coming out that will be additive to this and we will be talking about this in major meetings and you will see other supportive data coming out as well.

就時間而言，時間確實很重要。這不像治療濕性AMD，例如，在濕性AMD中，你可以看到——那裡可能有積液。使用抗VEGF藥物可以消除積液，功能可能會恢復。而感光細胞一旦死亡，就不會再再生。所以發病時間確實很重要。我們很高興看到，在這項回顧性分析中，發病時間處於早期階段。所以我認為最終這支持了我們的主要終點，也就是斜率分析。這是主要終點的支持性數據。我再次強調，我認為這傳達的訊息是，視力很重要，時間也很重要。是的，將會有數據出來補充這一點，我們將在重要的會議上討論這個問題，你也會看到其他支持性數據出來。

And if I can ask one more question, lot of people are talking about target populations who is the low-hanging fruit. And I think you even said in the past, bilateral patients did lost vision in one eye and have the risk of loss in another eye, as well as possibly patients with GA in one eye and wet AMD and another because they're already in the practices. So I guess I'm curious about the latter target population. You had not studied patients with wet AMD and the other. I just want to make sure I understand it correctly. You had excluded patients with wet AMD in the other eye, I think just to reduce the risk of conversion. So how do we square that with the target population that you might go after? Or maybe I just didn't understand it correctly, maybe you can clarify?

我想再問一個問題，很多人都在談論那些唾手可得的目標族群。我記得您之前甚至說過，雙眼視力喪失的患者確實一隻眼視力喪失，另一隻眼也有失明的風險，也可能是一隻眼患有GA，另一隻眼患有濕性AMD的患者，因為他們已經在診所了。所以我對後者的目標族群很好奇。您之前沒有研究過濕性AMD和另一隻眼睛患有濕性AMD的患者。我只是想確認一下我的理解是否正確。您排除了另一隻眼患有濕性AMD的患者，我想這只是為了降低轉換風險。那麼，我們如何將這與您可能瞄準的目標人群聯繫起來？或者也許我只是理解錯了，您能解釋一下嗎？

Yeah, to be very clear, the reason that we excluded patients with a choroidal neovascular membrane in the fellow eye is really quite simple. It's because if we want to ensure that there is no crossover effect, these patients would effectively having to come in for up to two years, every other week to be injected in one eye at a time and we felt that, that was an excessive burden to be placed on these patients in clinical trials. And that's why those patients were excluded. That was the only reason no other.

是的，說得更清楚些，我們排除對側眼有脈絡膜新生血管膜的患者的原因其實很簡單。因為如果我們想確保沒有交叉效應，這些患者實際上必須每隔一周來一次，每次注射一次，持續長達兩年。我們認為，在臨床試驗中，這給這些患者帶來了過重的負擔。這就是我們排除這些患者的原因。這是唯一的原因，沒有其他原因。

In terms of the target patient population, I don't think the fellow eye exclusion has any bearing on the target population or whatsoever. I think what clinicians are looking for is a effective, efficacious and safe treatment and I believe that as a clinician, I think all of my patients with geographic atrophy and also with severe intermediate macular degeneration are patients that I would consider for treatment.

就目標患者群體而言，我認為排除同側眼對目標族群沒有任何影響。我認為臨床醫生尋求的是有效、有效率且安全的治療方法。我相信，作為一名臨床醫生，所​​有患有地圖樣萎縮以及嚴重中度黃斑部病變的患者都是我會考慮治療的患者。

So I think, again, what we provided here today, the post-hoc analysis is a basis for that conversation, which is that there is potential here. Again, this is an exploratory retrospective analysis, but there's potential here to prevent catastrophic vision loss. And I think that is quite impactful.

所以，我認為，我們今天在這裡提供的，事後分析是這次討論的基礎，也就是說，這其中存在著潛力。再次強調，這是一項探索性的回顧性分析，但它有可能預防災難性的視力喪失。我認為這是非常有影響力的。

The next question comes from Ken Cacciatore with DD Cowen.

下一個問題來自 DD Cowen 的 Ken Cacciatore。

Wondering if maybe just step back and take a little bit of a crack at talking about the market in itself, the size and maybe how we should be thinking about the evolution of it. And then, Pravin, you get to be -- you're someone who's sat in front of real patients with this real issue. Can you just talk about their motivation to treat? I know there's a lot of discussion about the frequency of treatment, but would really like to get your perspective on it. And then maybe within that, how the real world use on dosing may play out? And then just lastly, you keep on highlighting intermediate and it makes a lot of sense. Can you just talk about what the implications of that would be on utilization? And how would it differentiate the label if you were able to get it?

我想知道，我們是否可以退一步，稍微談談市場本身、市場規模，以及我們應該如何看待它的發展。 Pravin，您曾經面對過真正的患者，並且正在面對同樣的問題。您能談談他們接受治療的動機嗎？我知道關於治療頻率的討論很多，但我真的很想聽聽您的看法。在此範圍內，現實世界中劑量的使用情況會如何？最後，您一直強調中間劑量，這很有道理。您能談談這對藥物利用率的影響嗎？如果您能夠做到這一點，它將如何區分不同的標籤？

Let me first ask Chris Simms, who's our Chief Commercial Officer to answer the first part of the question that you ask and I'll handle the rest. Chris?

首先，請允許我請我們的首席商務官克里斯·西姆斯 (Chris Simms) 回答您提出的問題的第一部分，然後我會處理剩下的部分。克里斯？

I think the first part of your question is related to market size and I think you'll share what we've shared previously. We believe it's a significant market. As we've said publicly, best measure is that we play there's about 1.5 million to 2 million patients in the U.S. alone that have some level or some stage of geographic atrophy. We also believe that number could be undiagnosed based on the sources of those data and the fact that some of that data is from number of years back. And one of the things that we believe is important for this market is the education, notably upstream where we believe a lot of these patients are not sitting with retina practices today. We believe the majority are under the care of a upstream ophthalmologist or an optometrist. So therefore, the need, I think, to educate and engage with that community is critical to help facilitate awareness and hopefully ultimately diagnosis and referral for treatment. So our modeling on the market has not changed. We still believe it's quite a significant market. However, the need for that education remains pretty high. I hope that helps?

我認為您問題的第一部分與市場規模有關，我想您可以分享我們之前分享的內容。我們認為這是一個重要的市場。正如我們公開表示的那樣，最好的衡量標準是，僅在美國就有大約150萬到200萬患者患有不同程度或不同階段的地圖狀萎縮。我們也認為，根據這些數據的來源以及部分數據來自多年前的事實，這個數字可能未被診斷出來。我們認為對這個市場來說，重要的一點是教育，尤其是在上游，我們認為許多患者目前並沒有在視網膜診所接受治療。我們相信大多數患者都在上游眼科醫師或驗光師的診療下接受治療。因此，我認為有必要對這個群體進行教育並與他們互動，以幫助提高人們的意識，並最終實現診斷和轉診治療。因此，我們對市場的預測並沒有改變。我們仍然認為這是一個相當重要的市場。然而，對這種教育的需求仍然很高。我希望這有幫助？

The other questions, I can. So the conversations with the patient and what this means to me as a clinician, this retrospective data. And as I mentioned to Annabel, this allows me a language of that I can have with the patient, which is to say, when you have a loss of vision of 15 letters or more, that truly changes a patient's life. That is catastrophic. And to be able to decrease the risk of that is really quite meaningful. So that allows me an avenue to have a very direct and very transparent conversation with the patient.

其他問題我可以回答。所以，我與患者進行對話，並了解這些回顧性數據對我作為臨床醫生意味著什麼。正如我之前對安娜貝爾提到的，這讓我能夠與患者進行溝通，也就是說，當視力喪失15個字母或更多時，患者的人生將發生翻天覆地的變化。這無疑是災難性的。能夠降低這種風險真的意義重大。這讓我能夠與患者進行非常直接、透明的對話。

And the other question might be, well, what kind of patient? And I know there's been a lot of discussion regarding center involving or non-center involving patient. And I just want to clarify that as a clinician, look, I believe all patients with geographic atrophy, center involving and non-center involving early and advanced all of these patients are eligible. A patient who has center-involving geographic atrophy may not progress as quickly as a patient that doesn't have center-involving geographic atrophy. However, a lot of these patients when I was in practice would come in, their head may be a little bit tilted. They would be looking from a island of parafoveal photoreceptor cells that they've preserved and that's what would allow them from tripping over furniture and burning their hands on stoves and et cetera.

另一個問題可能是，什麼樣的病人？我知道關於中心涉及型或非中心累及型患者已經有很多討論。我想澄清的是，作為一名臨床醫生，我認為所有患有地圖樣萎縮的患者，無論是中心累及型還是非中心累及型，早期和晚期患者都符合條件。患有中心性累及型地圖樣萎縮的患者病情進展可能不如非中心累及型患者快。然而，當我行醫時，許多這樣的病人來就診時，頭部可能略微傾斜。他們會透過保留的旁中心凹感光細胞島來觀察，這可以防止他們被家具絆倒、被爐子燙傷手等等。

So this drug will be very valuable for those patients. I would argue that those patients would benefit directly from this drug. Now would I enroll a patient like that in a clinical trial? Probably less likely because it's less measurable, the delta would be, but that doesn't mean that the patient wouldn't have a great deal of benefit from this drug.

所以這種藥物對這些患者來說非常有價值。我認為這些患者會直接從這種藥物中受益。現在我會招募這樣的病人參加臨床試驗嗎？可能性較小，因為增量（delta）難以測量，但這並不意味著患者不會從這種藥物中獲得很大的益處。

So the bottom line to my answer is that yes, I think all patients regardless of how big the geographic atrophy is and where it is, unless, of course is completely burnt out would be eligible for a safe and efficacious drug.

所以我的答案的底線是，是的，我認為所有患者，無論地圖狀萎縮有多大，在哪裡，當然，除非完全精疲力竭，都有資格獲得安全有效的藥物。

In terms of dosing, look, I -- you know that we will have every other month data in our second half of the year and of the second half of the study, of course. And our first year card turn was on September 7. So you can do the mathematics there. However, dosing is -- in my opinion is really not dosing frequency is not going to be determined by what's in the label, it's really going to be determined by what the patient can do. The conversation is going to go something like this.

至於劑量，你看，我──你知道，我們當然會在下半年，也就是研究的後半段，每隔一個月收集一次資料。我們第一年的病例報告是在9月7日。所以你可以做一下計算。然而，在我看來，劑量——用藥頻率實際上並非由標籤上的內容決定，而是由患者的實際情況決定。對話大概是這樣的。

I'd say Mrs. Smith, we have a drug that will help you and reduce your chance of having catastrophic vision loss potentially. And to get the best results, you would come in every month as close to every month as you can. And Mr. or Mrs. Smith would then come in as close to every month as he or she can. And that will determine the frequency of treatment not necessarily what's written in a label.

我想說，史密斯太太，我們有一種藥物可以幫助您，並降低您嚴重視力喪失的風險。為了達到最佳效果，您最好盡可能每個月來一次。史密斯先生或史密斯太太也應該盡可能每個月都來一次。這將決定治療的頻率，而不一定取決於標籤上寫的是什麼。

As far as your question on intermediate macular generation goes, look, there's a very broad range here. Intermediate macular generation can be anywhere from one drusen to severe intermediate macular degeneration where patients have metamorphopsia, changes in color contrast sensitivity, et cetera, with large drusen and serous fluid. We have said publicly that we will not be doing an intermediate macular degeneration study in order to target this patient population. And we believe that having a safe and efficacious drug as we believe ACP has the potential to be will allow us to target that patient population as well.

至於您關於中期黃斑部病變的問題，請注意，這涉及的範圍非常廣泛。中期黃斑部病變可以是單一視網膜玻璃膜疣，也可以是嚴重的中期黃斑部病變，例如患者出現視物變形、色彩對比敏感度改變等，並伴隨較大的視網膜玻璃膜疣和漿液。我們已經公開表示，我們不會針對這類患者族群進行中期黃斑部病變研究。我們相信，擁有像ACP這樣安全有效的藥物，將使我們能夠針對這類患者群體進行研究。

The next question comes from Eli Merle with UBS.

下一個問題來自瑞銀的 Eli Merle。

And exciting data on vision loss, maybe can you just comment a little bit in terms of the vision loss definition of 15 letters or greater? And I guess, why '15 and whether you looked at other thresholds as well?

關於視力喪失的數據令人興奮，您能否就視力喪失的定義（15 個字母或更大）稍微評論一下？為什麼是“15”，您是否也考慮過其他閾值？

The 15-letter milestone or landmark is really traditionally accepted as one that is a devastating amount of vision loss or a significant amount of vision gain and that's the doubling of the vision angle. And that's traditionally accepted by regulatory agencies as a important landmark. That's the reason that we chose to show that and do the analysis in this particular press release.

15個字母的里程碑或界標通常被認為是視力喪失達到毀滅性程度或視力獲得顯著提升的標誌，也就是視角加倍。這通常被監管機構視為重要的里程碑。這就是我們選擇在這篇新聞稿中展示並進行分析的原因。

Now having said that, yes, we've done sensitivity analysis on several other landmarks as well and we're convinced because of the sensitivity analysis that we've done exhaustively that this trend is a real trend. Again, I want to emphasize that this is a prespecified safety endpoint. It is a post-hoc analysis. But yes, we've done a numerous and exhaustive sensitivity analysis on this and are convinced that this trend is real and that it is impactful.

話雖如此，我們也對其他幾個里程碑事件進行了敏感度分析，並且基於我們詳盡的敏感度分析，我們確信這種趨勢是真實存在的。我再次強調，這是一個預先設定的安全終點，是事後分析。但是，是的，我們已經對此進行了大量的、詳盡的敏感性分析，並且確信這種趨勢是真實存在的，而且具有影響力。

And maybe just in terms of sensitivity analysis, is that data that we'll see at the presentation? And just if you can comment if there were any subgroups where you saw perhaps an even greater effect?

就敏感度分析而言，這些數據會在演示中展示嗎？您能否評論一下，是否有任何亞組研究的效果可能更大？

Yeah, Eli, we have not yet put together that presentation as yet, so I can't comment on that. We will certainly be showing the data that we've released today. And what I can tell you is that we will -- we are doing extensive studies based on providing you additional information regarding this functional benefit or potential functional benefit, which will be presented in other major meetings as well.

是的，Eli，我們還沒有整理好那個演示文稿，所以我無法評論。我們肯定會展示今天發布的數據。我可以告訴你的是，我們正在進行廣泛的研究，以便為您提供有關此功能優勢或潛在功能優勢的更多信息，這些信息也會在其他重要會議上展示。

The next question comes from Mike Ulz with Morgan Stanley.

下一個問題來自摩根士丹利的 Mike Ulz。

Maybe just a follow-up on the promising vision loss data you provided this morning. Just curious if you're considering maybe exploring that further and maybe a prospective lead design study?

也許只是對您今天早上提供的有希望的視力喪失數據的後續跟進。我只是好奇您是否考慮進一步探索這個問題，並進行一項前瞻性的先導設計研究？

What we've shown today is a post-hoc retrospective study and we believe that this is very impactful, very important data that supports the primary endpoint. That's the reason we presented this. We also believe that it forms a basis for doing future studies that may well be prospective and randomized. Certainly, these are things that we can add on to with future studies. And all future -- all prospective randomized studies are really based on data that you get from encouraging retrospective analyses. So it certainly forms a path and a basis for future studies.

我們今天展示的是一項事後回顧性研究，我們認為這是非常有影響力、非常重要的數據，它支持了主要終點。這就是我們展示這項研究的原因。我們也認為，它為未來進行前瞻性和隨機性研究奠定了基礎。當然，我們可以在未來的研究中補充這些內容。所有未來的——所有前瞻性隨機研究實際上都基於鼓勵回顧性分析所獲得的數據。因此，它無疑為未來的研究奠定了基礎和路徑。

Having said that, however, remember, our expectation and our goal per our agreements that we've outlined with the regulatory agencies, our submission and potential acceptance of our NDA filing based on the 12-month primary endpoint and that hasn't changed. I just want to make sure that we don't confuse those two things. Our expectation is that the NDA will be reviewed based on our prespecified agreements that we've had with the FDA based on the SPA, based on the breakthrough designation and based on the primary endpoint, which is at month 12.

話雖如此，但請記住，我們與監管機構達成的協議中的預期和目標，以及我們提交的NDA申請和可能獲得批准的申請，都是基於12個月的主要終點，這一點並沒有改變。我只是想確保我們不會混淆這兩件事。我們的預期是，NDA的審查將基於我們與FDA達成的預先設定的協議，這些協議是基於SPA、突破性療法認定以及主要終點（即12個月）。

The next question comes from Greg Harrison with Bank of America.

下一個問題來自美國銀行的格雷格·哈里森。

Are there any thoughts that you can share with us on the breadth via Apellis label? And without going into your discussions, maybe just if there's any implications that for your label as a result of what we've seen with them?

關於 Apellis 品牌的廣度，您有什麼想法可以跟我們分享嗎？先不談你們的討論，只是根據我們在 Apellis 品牌上看到的情況，能否談談這對你們的品牌有什麼影響？

It really would be inappropriate for any of us to comment about Apellis other than to say what -- and after this, maybe Glenn wants to say a few words as well. Other than to say, we are very happy that patients are getting a treatment. It's long overdue and Apellis and the entire team deserves a great deal of credit for coming across the line here in terms of having a medicine that will help patients. We look forward to seeing how their launch is. We wish them very, very well, but it really would not be appropriate for us to comment on a competitor's label.

我們任何人對Apellis發表評論都不合適，除了說說——之後，也許Glenn也想說幾句。除了說，我們很高興患者得到了治療。這早就該發生了，Apellis和整個團隊值得稱讚，他們終於找到了一種能夠幫助患者的藥物。我們期待看到他們的上市進展。我們非常非常祝福他們一切順利，但我們真的不宜對競爭對手的標籤發表評論。

Maybe I can pass it to Glenn and see Glenn has a few words to say as well.

也許我可以把它傳給格倫，看看格倫也有一些話要說。

And I go back to what we just said in the script, I congratulate them. It's really exciting to see a company finally be able to have a drug that patients could use and I think that's just outstanding. As Pravin said, we wish them luck. We will learn a lot from them and we're just thrilled that patients and we're thrilled the patients have the drug available to them and we're thrilled for Apellis.

我回到我們剛才在劇本裡說的，我祝賀他們。看到一家公司終於能夠研發出一種患者可以使用的藥物，真是令人興奮，我認為這真是太棒了。正如Pravin所說，我們祝他們好運。我們會從他們身上學到很多東西，我們很高興患者能夠獲得這種藥物，我們也為Apellis感到高興。

And then as you -- you're in the review process here and preparing for U.S. commercialization. Where are you in the process of potentially finding an ex-U.S. commercialization partner? And what are you looking for in such a partner?

那麼，你們現在正處於審查階段，準備在美國進行商業化。你們目前在尋找美國以外的商業化合作夥伴方面處於什麼階段？你們希望找到什麼樣的合作夥伴？

I think with today's data, we continue to build on the data set. And I think all of this is very important in to finding a future partner. As we said in the past, we do have a number of meetings in the first half of the year with European regulators, which will give us more guidance. Having data like we presented today, we believe may be helpful in those discussions. So that will -- continues to move forward. Our objective, as we have said in the past is to focus on the U.S. market and to find help overseas. (inaudible) another point of reference or data that will be helpful in that ex U.S. discussion. So that all continues and we'll keep you posted on our ongoing discussions with European regulators.

我認為，憑藉今天的數據，我們將繼續建立數據集。我認為所有這些對於尋找未來的合作夥伴至關重要。正如我們過去所說，今年上半年我們確實與歐洲監管機構舉行了多次會議，這將為我們提供更多指導。我們相信，像我們今天提供的數據，可能有助於這些討論。因此，我們將繼續推進這項工作。正如我們過去所說，我們的目標是專注於美國市場，並在海外尋求幫助。 （聽不清楚）另一個參考點或數據將有助於我們在美國以外的討論。所有工作都將繼續進行，我們將隨時向您通報我們與歐洲監管機構的持續討論情況。

The next question comes from Eddie Hickman with Guggenheim Securities.

下一個問題來自古根漢證券公司的艾迪希克曼。

Just a few from me. Throughout GATHER2, you were able to provide updates on the injection fidelity, which gave you confidence on meeting that primary endpoint. Are you able to give any color on how that's tracking so far in the second year?

我只想問幾點。在整個 GATHER2 期間，您一直能夠提供注射保真度的更新信息，這讓您有信心達到主要終點。您能否透露一下第二年到目前為止的進展？

What I can tell you is, as of now, we haven't guided to the numbers as yet, but I can tell you that we're very, very pleased with the way that, that's tracking. We've got a fantastic clinical operations team and they're very, very hard at work to make sure that all these patients are retained and that the injection fidelity is as high as possible. So we haven't given guidance as to the numbers as yet, but I can tell you that we're doing very well and are very pleased with the ongoing process.

我可以告訴你們的是，截至目前，我們還沒有公佈具體的數字，但我可以告訴你們，我們對目前的追蹤方式非常非常滿意。我們擁有一支優秀的臨床營運團隊，他們非常非常努力地工作，以確保所有患者都能保留，並且注射保真度盡可能高。因此，我們還沒有公佈具體的數字，但我可以告訴你們，我們做得非常好，並且對正在進行的流程非常滿意。

And then really interesting visual acuity data that you presented, I'm curious, is that something you can share with the FDA as part of your back and forth that you get with your breakthrough designation, without needing to file any additional amendments just to sort of show them the confidence that you're seeing on that functional endpoint throughout the early part of the review?

然後，您提供的非常有趣的視力數據，我很好奇，您是否可以與 FDA 分享這些數據，作為您在突破性療法認定過程中反复溝通的一部分，而不需要提交任何其他修正案，只是為了向他們展示您在審查初期對該功能終點的信心？

Eddie, as you know, we're under review at this time. We've said publicly that we are very pleased with our interactions with the FDA. We found them as expected to be extraordinarily collaborative. And we're -- and we feel that the questions that are going back and forth are exactly the right questions that we would like and that we are doing. We believe everything the way that we -- that the FDA would like us to. So we're very, very happy with the interactions. But other than that, we certainly don't want to be publicly commenting on any details regarding the discussions that we're having with the FDA, but thank you for your question.

艾迪，如你所知，我們目前正在接受審查。我們曾公開表示，我們對與FDA的互動非常滿意。正如預期的那樣，我們發現他們的合作非常愉快。而我們覺得，我們反覆討論的問題正是我們想要的，也是我們正在做的。我們相信一切都符合FDA的期望。所以我們對這些互動非常非常滿意。但除此之外，我們當然不想公開評論我們與FDA討論的任何細節，但還是感謝你的提問。

Next question comes from Kambiz Yazdi with Jefferies.

下一個問題來自 Jefferies 的 Kambiz Yazdi。

Can you provide us any more color on your interactions with the FDA on intermediate AMD? And then may a few more follow-ups after that.

您能否提供更多關於您與FDA在中期AMD互動的細節？之後可能會有更多後續報道。

What we've said publicly is that with the interactions that we've had that we will not be doing an intermediate AMD study. As we -- as we've announced I think some time ago, we feel that we'll be able to target intermediate AMD without doing a specific study for intermediate AMD because this is considered a continuum of disease. We said that publicly and other than that, we have not guided as to any further details regarding our interactions with the FDA.

我們公開表示，鑑於我們與FDA的溝通，我們不會進行中期AMD的研究。正如我們之前宣布的那樣，我們認為我們能夠針對中期AMD，而無需進行專門的研究，因為這被認為是一種連續的疾病。我們公開表示了這一點，除此之外，我們沒有透露任何有關我們與FDA溝通的進一步細節。

And then if ACP is approved in August, what would be the general time frame for receiving a permanent J-Code for ACP?

那麼，如果 ACP 在 8 月獲得批准，那麼獲得 ACP 永久 J 代碼的一般時間範圍是怎樣的？

Chris, maybe I can pass that question on to you.

克里斯，也許我可以把這個問題轉達給你。

So following our August PDUFA date, it's an important question by the way. So we plan to file at the first quarterly opportunity, which again based on the August PDUFA date would be the 2nd of October would be the first opportunity to file for the permanent J-Code. And then following that time, we would expect to get the permanent and hopefully get the permanent J-Code in early second quarter of '24.

順便說一句，在8月份的PDUFA日期之後，這是一個重要的問題。我們計劃在第一個季度機會時提交申請，根據8月份的PDUFA日期，10月2日將是第一個申請永久J代碼的機會。之後，我們預計將獲得永久J代碼，並預計在2024年第二季初獲得永久J代碼。

And one final one, just to put a final point on every other month dosing. If the data are positive from year two of GATHER2, would you pursue every other month dosing for ACP, would this have to come as NDA? Appreciate all the answers today.

最後，我想補充一下關於隔月給藥的方案。如果GATHER2研究第二年的資料是正面的，你們會繼續採用隔月給藥的方案嗎？這需要以保密協議（NDA）的形式嗎？非常感謝今天大家的回答。

Yeah, Kambi, so we have not guided us to that. We obviously want to see the data. We want to see what the situation is like at that time, that's a decision to be made down the road. But we really don't believe that having every other month dosing really provides any kind of a competitive advantage because we believe that physicians will treat according to what's best for the patient and what's best for the patient is going to be dependent also on how often the patient can come in and that's going to be the primary determinant of the frequency of treatment, not what's written in the label.

是的，Kambi，所以我們沒有指導我們這麼做。我們當然想看看數據。我們想看看當時的情況，這是一個需要日後再做決定的問題。但我們真的不認為每隔一個月服藥一次真的能帶來任何競爭優勢，因為我們相信醫生會根據患者的最佳情況進行治療，而患者的最佳治療方案還取決於患者的就診頻率，而這才是治療頻率的主要決定因素，而不是標籤上寫的。

And just to kind of put a emphasis on this, if you look at the anti-VEGF experience for instance, the vast majority of us treat and extend and that's not in any label. So there is a history of my colleagues really doing what's right for the patient, given the particular situation regardless of what the label says. So the answer to your question is, look, I'm not really sure what we will do with the 24-month data, whether it be on the label or not, that's yet to be determined.

需要強調的是，以抗VEGF治療為例，我們絕大多數人都會進行治療並延長療程，而這在任何標籤上都沒有註明。因此，我的同事一直致力於根據患者的具體情況，採取真正適合患者的做法，無論標籤上如何說明。所以，對於你的問題，我的答案是：我不太確定我們會如何處理24個月的數據，無論標籤上是否註明，這都還有待確定。

This concludes our question-and-answer session. I would like to turn the conference back over to Glenn Sblendorio for any closing remarks.

我們的問答環節到此結束。現在請 Glenn Sblendorio 致閉幕詞。

Thank you, Andrew and thanks, everyone for listening this morning and we're very happy and pleased with our progress and we look forward to our continued work with the FDA on our NDA filing and hopefully a potential approval in late August of this year. We're also committed as we talked about today to building a world-class commercial team to be ready to engage physicians, healthcare providers and patients if ACP is approved. And finally, we look forward to having our vision loss data presented at ARVO. So you can expect continued execution from us. We always enjoy speaking to all of you and have a great day. Bye-bye.

謝謝安德魯，也謝謝大家今天早上的聆聽。我們對進展感到非常高興和欣慰，期待繼續與FDA合作提交NDA申請，並希望在今年8月底獲得批准。正如我們今天所說，我們也致力於打造一支世界一流的商業團隊，一旦ACP獲得批准，我們將隨時準備與醫生、醫療保健提供者和患者進行溝通。最後，我們期待在ARVO大會上展示我們的視力喪失數據。因此，您可以期待我們繼續執行。我們很高興與大家交流，祝大家有美好的一天。再見。

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

會議現已結束。感謝您參加今天的演講。您可以斷開連線了。