Apellis Pharmaceuticals Inc (APLS) 2023 Q3 法說會逐字稿

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the Apellis Pharmaceuticals Third Quarter 2023 Earnings Conference Call. At this time, all participants on a listen-only mode. (Operator Instructions). Please note that today's conference is being recorded.

各位女士、先生，早安。感謝您稍候，歡迎參加 Apellis Pharmaceuticals 2023 年第三季財報電話會議。此刻，所有與會者將以僅收聽模式參與。（接線員指示）請注意，今日會議將被錄音。

I will now hand the conference over to your speaker host, Meredith Kaya, Senior Vice President, Investor Relations and Stategic Finance. Please go ahead.

現在我將把會議交給本次主講人暨主持人 Meredith Kaya，投資人關係與策略財務資深副總裁。請開始。

Good morning, and thank you for joining us to discuss Apellis' Third Quarter 2023 Financial Results. With me on the call are Co-Founder and Chief Executive Officer; Dr. Cedric Francois, Chief Commercial Officer, Adam Townsend, Chief Medical Officer, Dr. Caroline Baumal and Chief Financial Officer, Tim Sullivan.

早安，感謝各位加入我們，一同討論 Apellis 2023 年第三季財務結果。與我一同參與電話會議的有共同創辦人兼執行長 Cedric Francois 博士、商務長 Adam Townsend、醫務長 Caroline Baumal 博士，以及財務長 Tim Sullivan。

Before we begin, let me point out that we will be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC filings for additional detail. Now I'll turn the call over to Cedric.

在開始之前，我要指出我們將發表以前瞻性陳述為主的內容，這些陳述係基於我們目前的預期與信念。此等陳述受若干風險與不確定性影響，實際結果可能出現重大差異。我鼓勵各位參閱我們向 SEC 提交文件中所討論的風險因素，以取得更多細節。現在我將把電話會議交給 Cedric。

Thank you, Meredith, and thank you all for joining us this morning. It has been a busy few months here at Apellis and the period not without its share of ups and downs. That said, I am thrilled with where our company is today, and I'm more confident than ever in the opportunities that we have in front of us. Importantly, we are delivering on our goals of bringing EMPAVELI and SYFOVRE to patients with nearly $100 million in total U.S. net product revenue generated in the third quarter and continuing to develop a pipeline of potentially transformative new treatments.

謝謝你，Meredith，也感謝各位今天早上加入我們。對 Apellis 而言，過去幾個月非常忙碌，期間也不乏起伏。儘管如此，我對公司目前的狀況感到非常振奮，並且比以往任何時候都更有信心面對眼前的機會。重要的是，我們正達成將 EMPAVELI 與 SYFOVRE 帶給病患的目標：第三季在美國合計創造近 1 億美元的產品淨營收，同時持續推進可能具變革性的全新療法研發管線。

I'll begin with SYFOVRE . We reported $75 million in SYFOVRE U.S. net product revenue in the third quarter, up about 12% quarter-over-quarter, resulting in more than $160 million in U.S. net product revenue generated in the first 7 months since launch. A few key highlights include more than 100,000 vials of SYFOVRE have been distributed since launch through our last update on October 5, which we believe underscores the positive impact it is having on the lives of thousands of patients across the U.S.

我先從 SYFOVRE 談起。我們第三季 SYFOVRE 在美國的產品淨營收為 7,500 萬美元，較前一季約成長 12%，使得自上市後前 7 個月在美國累計產品淨營收超過 1.6 億美元。幾項重點包括：截至我們 10 月 5 日的最新更新，自上市以來已配送超過 100,000 瓶 SYFOVRE，我們認為這凸顯其對全美數千名病患生活所帶來的正面影響。

The permanent J code became effective on October 1, driving even stronger demand to date with some of our largest weeks ever in October. The long-term data emerging from our GALE extension study continues to show increasing effects over time, a seminal feature of SYFOVRE's efficacy profile and additional analyses have been presented this fall, demonstrating the visual function benefits of SYFOVRE GA patients. And finally, the estimated rate of retinal vasculitis with SYFOVRE continues to be rare at 0.01%. Visual outcomes in these cases are really important and the rate of events that resulted in severe irreversible vision loss is substantially less than 0.01%. Given the continued stability in the rates, we plan to continue to provide the estimated rate of events, but will no longer discuss individual cases.

永久 J code 已於 10 月 1 日生效，迄今帶動更強勁的需求，使我們在 10 月出現一些史上最大的單週表現。GALE 延伸研究所產生的長期數據持續顯示療效隨時間增強，這是 SYFOVRE 療效特徵中的里程碑式要點；此外，今年秋季也發表了更多分析，顯示 SYFOVRE 對 GA 病患的視覺功能具有益處。最後，SYFOVRE 相關視網膜血管炎的估計發生率仍屬罕見，為 0.01%。這些案例的視覺結果非常重要，而導致嚴重且不可逆視力喪失的事件比例顯著低於 0.01%。鑑於發生率持續穩定，我們計畫繼續提供事件的估計發生率，但將不再討論個別案例。

The success of SYFOVRE reinforces the unmet need in GA and the strength of our product profile. We faced unexpected challenges with the rare events of vasculitis emerging this summer, but we have worked hard to build trust with the retina community through continued transparency and sharing the learnings from our investigation. In doing so, we have provided retina specialists with the information they need to make the right treatment decisions for their patients. I had the privilege of spending time with some of our key opinion leaders this fall at both Euretina and Retina Society. It was encouraging to hear the discussions shifting back to what this product can do for patients. After a challenging few months, we have turned the corner and believe we are now back to the demand growth trajectory that we were on in July.

SYFOVRE 的成功再次印證 GA 領域仍存在未被滿足的醫療需求，以及我們產品特性的優勢。今年夏天出現罕見血管炎事件帶來意料之外的挑戰，但我們透過持續透明溝通並分享調查所得的學習，努力與視網膜醫療社群建立信任。藉此，我們也讓視網膜專科醫師掌握所需資訊，以便為其病患做出正確的治療決策。今年秋季我有幸在 Euretina 與 Retina Society 與部分關鍵意見領袖交流，令人鼓舞的是，討論焦點正回到這項產品能為病患帶來什麼。在經歷幾個月的挑戰後，我們已經度過轉折點，並相信目前已回到 7 月時的需求成長軌道。

Globally, we are looking forward to the decision on our MAA submission for the European Medicines Agency, which is on track for early 2024. At Euretina, I was impressed with the incredible amount of work our European team has been doing to prepare for the launch. There was also a lot of enthusiasm from the European physicians about the possibility of finally having a treatment for their GA patients.

在全球方面，我們期待歐洲藥品管理局（European Medicines Agency）對我們 MAA 申請的審查決定，進度仍按計畫於 2024 年初出爐。在 Euretina 上，我對歐洲團隊為上市所做的大量準備工作印象深刻。歐洲醫師也對終於可能有治療方案可用於其 GA 病患感到非常振奮。

Turning to EMPAVELI. We generated $24 million in third quarter U.S. net product revenue and $67 million year-to-date. With EMPAVELI, we now have over 1,300 patient years and compliance rates at 97% and still not a single case of meningococcal infection. One of the key highlights for EMPAVELI during the quarter was receiving FDA approval for the EMPAVELI injector, an innovative and first of its kind high-tech volume injector. With this approval, we are further enhancing the patient's experience by offering rate mobility and simplifying administration.

接著談 EMPAVELI。我們第三季在美國創造 2,400 萬美元的產品淨營收，年初至今累計 6,700 萬美元。就 EMPAVELI 而言，我們目前累積超過 1,300 個病患年（patient years），依從率達 97%，且至今仍未出現任何腦膜炎雙球菌感染病例。本季 EMPAVELI 的一項重點里程碑是獲得 FDA 核准 EMPAVELI 注射器（injector），這是一款創新且同類首見的高科技大容量注射器。透過此項核准，我們進一步提升病患體驗，提供輸注速率的可調整性並簡化給藥流程。

We also announced top line data from our Phase II NOBLE study with systemic Pegcetacoplan in IC-MPGN and C3G, which will be presented this Saturday at the American Society of Nephrology. The strength of these data is driven by the speed and magnitude of effect that Pegcetacoplan had in the kidney, which is unprecedented in these diseases. We believe that we have an opportunity to significantly expand the number of patients who are benefiting from Pegcetacoplan as IC-MPGN and C3G affect more than 3x the treated PNH population. We look forward to the top line results from our Phase III Valeant study expected in the third quarter of 2024.

我們也公布了系統性 Pegcetacoplan 用於 IC-MPGN 與 C3G 的第二期 NOBLE 研究主要（top line）數據，並將於本週六在美國腎臟學會（American Society of Nephrology）發表。這些數據的強勁表現，來自 Pegcetacoplan 在腎臟中展現的作用速度與效果幅度，這在這些疾病中前所未見。我們相信，IC-MPGN 與 C3G 的患者人數超過已治療 PNH 人口的 3 倍，這使我們有機會大幅擴大能從 Pegcetacoplan 受益的病患族群。我們也期待 2024 年第三季公布第三期 Valeant 研究的主要結果。

Before I turn it over to Adam, I would like to comment on our recent corporate restructuring. In late August, we took actions to streamline our organization, prioritizing the growth of SYFOVRE and EMPAVELI and positioning the company for continued long-term success. This was a difficult decision, and we are grateful for the commitment and contributions of all of our colleagues. As a reminder, key elements of our reprioritization includes maximizing SYFOVRE's global leadership in GA, streamlining the EMPAVELI business, focused on the commercialization in PNH and development in IC-MPGN and C3G, prioritizing certain CNS and retina research initiatives and continuing our collaboration with Beam and finally, improving operational efficiencies.

在交給 Adam 之前，我想談談我們近期的企業重整。8 月下旬，我們採取行動精簡組織，優先推動 SYFOVRE 與 EMPAVELI 的成長，並使公司具備持續長期成功的定位。這是一項艱難的決定，我們也感謝所有同仁的投入與貢獻。提醒各位，我們重新排序優先事項的關鍵要素包括：最大化 SYFOVRE 在 GA 的全球領導地位；精簡 EMPAVELI 業務，聚焦於 PNH 的商業化以及 IC-MPGN 與 C3G 的開發；優先推進特定中樞神經系統（CNS）與視網膜研究計畫並持續與 Beam 的合作；以及提升營運效率。

We anticipate total cost savings of up to $300 million through 2024 as a result of this restructuring. And as Tim will speak to later, we expect our cash runway to now extend into at least the second quarter of 2025. As a more focused organization, we believe we are in a stronger position to create value for our shareholders and deliver on our mission for patients now and in the future. With that, I will now turn it over to Adam to discuss our commercial activities.

我們預期此次重整將在 2024 年前帶來最高可達 3 億美元的總成本節省。正如 Tim 稍後將說明的，我們也預期現金可支撐期（cash runway）如今可延伸至至少 2025 年第二季。作為更聚焦的組織，我們相信自己處於更有利的位置，能為股東創造價值，並在現在與未來持續實現我們對病患的使命。接下來我將把電話會議交給 Adam，請他說明我們的商業活動。

Thank you, Cedric. It was a strong quarter commercially for both SYFOVRE and EMPAVELI. Starting with SYFOVRE. In the third quarter, we delivered 37,000 commercial vials and 10,000 samples to physician practices, generating $75 million in U.S. net product revenue. We are encouraged by this performance. In particular, the quarter-over-quarter growth compared to Q2 and the return of weekly demand growth beginning in August. We believe this was driven by physicians and patients having a better understanding of the real-world safety profile of SYFOVRE and the long-term data, including increasing treatment effects seen in our GALE extension study.

謝謝你，Cedric。就商業表現而言，SYFOVRE 與 EMPAVELI 在本季都表現強勁。先從 SYFOVRE 開始。第三季我們向醫師診所交付 37,000 瓶商業用產品與 10,000 瓶樣品，帶來 7,500 萬美元的美國產品淨營收。我們對此表現感到鼓舞，特別是相較第二季的季對季成長，以及自 8 月起每週需求成長的回升。我們認為，這主要是因為醫師與病患對 SYFOVRE 的真實世界安全性特徵與長期數據有了更充分的理解，其中包括我們 GALE 延伸研究所觀察到的治療效果隨時間增加。

On October 1, the permanent J-code to SYFOVRE became effective, simplifying the billing and reimbursement process. This is a significant milestone that will help ensure efficient reimbursement of SYFOVRE, building on our goal of bringing this important treatment to all GA patients in need. As a result of our commercial execution, excellent payer coverage with more than 95% of Medicare payers now covering SYFOVRE, and the addition of the permanent J-code, demand is higher than where we were in July and growing. We continue to see weekly orders coming from both new and existing sites of care with a double-digit number of new sites of care ordering SYFOVRE every week since launch. Additionally, we are seeing the vast majority of physicians treating patients with SYFOVRE every 6 to 8 weeks, reinforcing how important dosing flexibility is for this patient population.

10 月 1 日，SYFOVRE 的永久 J-code 正式生效，簡化了帳單與給付流程。這是一項重要里程碑，有助於確保 SYFOVRE 能獲得高效率的給付，並支持我們將這項重要治療帶給所有有需求 GA 病患的目標。受惠於我們的商業執行、優異的保險給付涵蓋（目前超過 95% 的 Medicare 付款方已涵蓋 SYFOVRE），以及永久 J-code 的加入，目前需求高於 7 月水準且持續成長。我們持續看到每週訂單同時來自新的與既有的照護據點（sites of care），且自上市以來每週都有兩位數的新照護據點開始訂購 SYFOVRE。此外，我們也看到絕大多數醫師以每 6 至 8 週為病患施打 SYFOVRE，進一步印證劑量間隔彈性對此病患族群的重要性。

Our commercial strategy going forward is to remain laser-focused on engaging our key stakeholders, patients, physicians and payers. We plan to leverage this current momentum by building breadth, depth and retention among retina specialists. We are also preparing to bring SYFOVRE to patients globally. We are thoughtfully building out the European commercial infrastructure and subject to approval, plan to launch initially in Germany, where we can sell product immediately, while we work simultaneously to obtain reimbursement in other EU countries. Europe represents a significant opportunity for us as there are more than 2.5 million people living with GA and no treatment available. We recently submitted our dossier to the National Institute for Health and Care Excellence, or NICE, for reimbursement in the United Kingdom. We expect a decision by the local regulatory authorities in the U.K. as well as Canada, Australia and Switzerland in the first half of 2024.

我們未來的商業策略是持續高度聚焦於與關鍵利害關係人——病患、醫師與支付方——的互動。我們計畫藉由擴大在視網膜專科醫師族群中的覆蓋廣度、深化滲透並提升留存率，來延續目前的動能。我們也正準備將 SYFOVRE 推向全球病患。我們正審慎建置歐洲的商業基礎設施，並在獲准的前提下，計畫先在德國啟動上市，因為我們可在當地立即銷售產品，同時也將並行推進在其他歐盟國家取得給付。歐洲對我們而言代表重大機會，因為有超過 250 萬人罹患 GA，且目前尚無可用治療。我們近期已向英國國家健康與照護卓越研究院（NICE）提交給付申請資料。我們預期在 2024 年上半年，英國以及加拿大、澳洲與瑞士的當地主管機關將做出決定。

Turning to EMPAVELI. In the third quarter, we continue to see positive trends across the key leading indicators for this patient population, including more than 250 patients on therapy, over 75% of C5 inhibitor patient switches coming from ULTOMIRIS since launch. Patient compliance rates remaining high at 97% and continued strong access among the top 20 payers. We are also seeing continued growth coming from the treatment-naive population given the inclusion of the print data in the label and more experience with EMPAVELI. This progress resulted in $24 million in U.S. net product revenue for the third quarter. PNH is a market driven by both efficacy and safety, which is reflected in these continued strong results.

接著談 EMPAVELI。第三季，我們在此病患族群的關鍵領先指標上持續看到正向趨勢，包括治療中的病患超過 250 位；自上市以來，超過 75% 的 C5 抑制劑病患轉換來自 ULTOMIRIS。病患依從性維持在 97% 的高水準，且在前 20 大支付方中持續維持強勁的可及性。我們也看到因標籤納入印刷資料（print data）以及對 EMPAVELI 的使用經驗增加，使得來自未曾治療（treatment-naive）族群的成長持續擴大。上述進展帶動第三季美國淨產品營收達 2,400 萬美元。PNH 市場同時由療效與安全性所驅動，而這些持續強勁的結果正反映了這一點。

As Cedric mentioned, we are excited about the approval of the EMPAVELI injector. The field teams are now working to transition existing patients on to the injector. Initial feedback has been positive, and we look forward to bringing the injector to more and more patients over the coming months. We are also focused on bringing EMPAVELI to new patients who may benefit from this treatment and reinforcing the long-term safety and efficacy data and real-world experience. Now I will turn the call over to Caroline.

如 Cedric 所提到的，我們對 EMPAVELI 注射器獲准感到振奮。第一線團隊目前正著手協助既有病患轉換至注射器。初步回饋相當正面，我們也期待在未來幾個月將注射器帶給越來越多病患。我們同時也聚焦於將 EMPAVELI 帶給可能受益的新病患，並強化長期安全性與療效數據以及真實世界使用經驗。接下來我把電話交給 Caroline。

Thanks, Adam, and good morning, everyone. We have had a significant presence these past few months at multiple medical meetings, including the ASRS Annual Meeting, Euretina and the Retina Society meeting. The reactions and feedback we are hearing from the medical community, especially in these last several weeks support the solid performance of SYFOVRE and its continued growth. As shown on Slide 8, at ASRS, we presented for the first time the 30-month results of our GALE extension study, deepening our understanding of the long-term efficacy of SYFOVRE. These data continue to demonstrate increasing events with SYFOVRE out to 30 months and a safety profile consistent with previously reported clinical data.

謝謝你，Adam，各位早安。過去幾個月我們在多場醫學會議上都有相當高的能見度，包括 ASRS 年會、Euretina 以及 Retina Society 會議。我們從醫學界聽到的反應與回饋，特別是最近幾週，支持 SYFOVRE 的穩健表現及其持續成長。如投影片 8 所示，在 ASRS 上，我們首次發表 GALE 延伸研究的 30 個月結果，深化我們對 SYFOVRE 長期療效的理解。這些數據持續顯示，SYFOVRE 在長達 30 個月期間的事件（events）呈增加趨勢，且其安全性概況與先前報告的臨床數據一致。

In GALE, SYFOVRE reduced GA lesion growth with both monthly and every other month treatment compared to the projected sham arm with an even more pronounced effect in patients with nonsevolia lesions, the greatest effect shown by any GA therapy to date. Additionally, we continue to build on the functional data supporting the efficacy profile of SYFOVRE. We recently presented our third functional analysis showing a visual function benefit. In this post-hoc microperimetry analysis, data showed that SYFOVRE extended full light sensitivity in the Phase III OAK study, which is critical for prolonging visual function.

在 GALE 中，與推估的安慰劑（sham）組相比，SYFOVRE 以每月與隔月（every other month）給藥皆可降低 GA 病灶生長；在非 fovea（nonsevolia）病灶的病患中效果更為明顯，為迄今任何 GA 治療所呈現的最大效果。此外，我們也持續累積支持 SYFOVRE 療效概況的功能性數據。我們近期發表第三項功能性分析，顯示視覺功能獲益。在此事後（post-hoc）的微視野檢查（microperimetry）分析中，數據顯示 SYFOVRE 在第三期 OAK 研究中延長了完整光敏感度（full light sensitivity），這對於延長視覺功能至關重要。

We also presented an updated covariate adjusted analysis of visual acuity data at the Retina Society from our GALE long-term extension study. As we saw with the 24-month data at ARVO, we continue to see favorable trends on best corrected visual acuity in patients in the continuous SYFOVRE treatment arms as compared to patients on sham for 2 years who then crossed over to active treatment in GALE. Both of these analysis add to the overall efficacy profile of pegcetacoplan.

我們也在 Retina Society 會議上，發表來自 GALE 長期延伸研究的視力數據之更新版共變數校正（covariate adjusted）分析。如同我們在 ARVO 看到的 24 個月數據，我們持續觀察到：在持續接受 SYFOVRE 治療的組別中，相較於先接受 2 年安慰劑（sham）後在 GALE 轉換至主動治療的病患，其最佳矯正視力（best corrected visual acuity）呈現有利趨勢。這兩項分析皆進一步補強 pegcetacoplan 的整體療效概況。

We are looking forward to presenting at the upcoming American Academy of Ophthalmology meeting this weekend in San Francisco. At this meeting, we will share a 36-month data from our GALE extension study, further demonstrating SYFOVRE's long-term efficacy and increased effects over time and a consistent safety profile out to 3 years. As seen on Slide 9, we are also presenting new data this weekend at Kidney Week from the Phase II NOBLE study, investigating pegcetacoplan for the treatment of post-transplant recurrence of IC-MPGN and C3G.

我們期待本週末在舊金山舉行的美國眼科學會（American Academy of Ophthalmology）年會上進行發表。在該會議中，我們將分享 GALE 延伸研究的 36 個月數據，進一步證明 SYFOVRE 的長期療效、隨時間增加的效果，以及長達 3 年一致的安全性概況。如投影片 9 所示，本週末我們也將在 Kidney Week 發表第二期 NOBLE 研究的新數據，該研究評估 pegcetacoplan 用於治療移植後復發的 IC-MPGN 與 C3G。

IC-MPGN and C3G are rare debilitating kidney diseases that are estimated to affect 5,000 people in the United States and up to 8,000 in Europe with no approved treatments available. What is particularly striking in these data as shared in our recent press release is how quickly pegcetacoplan showed the potential for a treatment effect in translantic kidneys that have disease recurrence. In just 12 weeks, 80% of patients treated with pegcetacoplan showed a reduction in C3C staining by at least 1 order of magnitude of intensity from baseline. 50% showed a reduction in C3C staining by 2 or more orders of magnitude, which was the primary endpoint of the study and 40% showed 0 staining intensity, indicating that C3C deposits were cleared.

IC-MPGN 與 C3G 是罕見且致殘的腎臟疾病，估計在美國影響 5,000 人，在歐洲最多影響 8,000 人，且目前沒有核准的治療。這些數據中特別引人注目之處——如我們近期新聞稿所分享——是 pegcetacoplan 在出現疾病復發的移植腎（translantic kidneys）中，展現潛在治療效果的速度之快。僅 12 週內，接受 pegcetacoplan 治療的病患中有 80% 的 C3C 染色強度較基線至少降低 1 個數量級（order of magnitude）。其中 50% 的病患 C3C 染色強度降低 2 個或以上數量級，這也是研究的主要終點；另有 40% 顯示 0 染色強度，表示 C3C 沉積已被清除。

The image on this slide is an example of one patient. You can see the disease activity or C3C staining at baseline on the left with the immunofluorescence or bright green areas lit up. At week 12, you can see in the second image that it's gone. This magnitude of C3C clearing in the kidney has never been shown before. Additionally, treatment with pegcetacoplin showed improvements across key clinical measures, including proteinuria and stable kidney function. While this was a small study, these data indicate that pegcetacoplan is targeting the underlying cause of the disease, strengthening our confidence in pegcetacoplan as a potential treatment for both native and post-transplant forms of these rare and serious diseases.

本投影片上的影像是一位病患的例子。左側可見基線時的疾病活動度或 C3C 染色，在免疫螢光下呈現亮綠色區域。到第 12 週時，從第二張影像可見其已消失。如此幅度的腎臟 C3C 清除過去從未被展示。此外，pegcetacoplin 治療在多項關鍵臨床指標上也顯示改善，包括蛋白尿以及穩定的腎功能。雖然這是一項小型研究，但這些數據顯示 pegcetacoplan 正在針對疾病的根本原因，進一步強化我們對 pegcetacoplan 作為這些罕見且嚴重疾病之原發（native）與移植後型態潛在治療選項的信心。

We are currently enrolling patients in our Phase III Valeant study evaluating tesetacoplin in adolescent and adult patients with native and post-transplant recurrence IC-MPGN and C3G. Investigators in this study have been enthusiastic about bringing in new patients. We anticipate completing enrollment by the end of this year with top line results expected in the third quarter of 2024. Now I will turn the call over to Tim for a review of the financials. Tim?

我們目前正在招募病患進入第三期 Valeant 研究，以評估 tesetacoplin 用於青少年與成人病患之原發及移植後復發 IC-MPGN 與 C3G。參與本研究的試驗主持人對於納入新病患相當積極。我們預期在今年底前完成收案，並預計於 2024 年第三季取得主要結果（top line results）。接下來我把電話交給 Tim 進行財務回顧。Tim？

Thank you, Caroline. Total revenue for the third quarter was $110 million, which consisted of $24 million in EMPAVELI U.S. net product revenue, $75 million in SYFOVRE US net product revenue and $11 million in collaboration revenue from Sobi. As a reminder, revenue is recognized as shipments to the distributor and therefore, includes any product in inventory at the distributor as well as product shipped to the physician by the distributor. We continue to estimate approximately 2 to 3 weeks of inventory on hand at the distributor and expect these inventory levels to be consistent going forward based on anticipated demand.

謝謝你，Caroline。第三季總營收為 1.10 億美元，其中包括 EMPAVELI 美國淨產品營收 2,400 萬美元、SYFOVRE 美國淨產品營收 7,500 萬美元，以及來自 Sobi 的合作營收 1,100 萬美元。提醒一下，營收係以出貨至經銷商時點認列，因此包含經銷商庫存中的任何產品，以及經銷商出貨給醫師的產品。我們持續估計經銷商端約有 2 至 3 週的在手庫存，並預期在可預見的需求下，這些庫存水位未來將維持一致。

Turning to the rest of the P&L. R&D expenses were $79 million and G&A expenses were $146 million, and we reported a net loss of $140 million. I'd like to point out a few items in our financial statements that will help in evaluating our business. First, cost of goods sold was $22.4 million for the third quarter, higher than in previous periods due to milestone payments to pen and purchase price variances combined totaling approximately $8.6 million. Second, we recorded accounts receivable of $169.3 million, which is also higher than previous quarters and is primarily associated with payment terms that we provide to the Sipo distributors. The accounts receivable line item has increased as Sipo sales have increased and is in line with those payment terms. Third, we are now categorizing a majority of medical affairs and certain other costs in G&A instead of in R&D. This represents an approximately $19 million shift from R&D to G&A in the current quarter. No reclassifications were necessary for prior periods. However, it is important to note when reviewing trends in our operating expenses.

接著看損益表其餘項目。研發（R&D）費用為 7,900 萬美元，一般及行政（G&A）費用為 1.46 億美元，我們報告淨損 1.40 億美元。我想指出財務報表中幾個有助於評估我們業務的項目。第一，第三季銷貨成本為 2,240 萬美元，較先前期間為高，主要因支付給 pen 的里程碑款以及採購價格差異合計約 860 萬美元。第二，我們認列應收帳款 1.693 億美元，也高於前幾季，主要與我們提供給 Sipo 經銷商的付款條件相關。隨著 Sipo 銷售增加，應收帳款科目亦隨之上升，且符合上述付款條件。第三，我們目前將多數醫藥事務（medical affairs）及其他部分成本歸類於 G&A，而非 R&D。這使得本季約有 1,900 萬美元自 R&D 轉列至 G&A。先前期間無需重分類。然而，在檢視營運費用趨勢時，務必留意此點。

And finally, our operating expenses do not yet reflect the ongoing efficiencies we expect from our restructuring due to severance and winding down of certain projects. We expect to realize these efficiencies beginning in 2024. As of September 30, 2023, we had $452 million in cash and cash equivalents. September and October demand provided us with a better view of the demand and sales trajectory going forward. And based on this, and cost savings from our recent restructuring, we now expect our cash balance to fund our operations into at least the second quarter of 2025. I will now turn the call back over to Cedric for closing remarks. Cedric?

最後，我們的營運費用尚未反映我們因重組而預期可持續取得的效率提升，原因在於遣散費以及部分專案的收尾與終止。我們預期自 2024 年起開始實現這些效率。截至 2023 年 9 月 30 日，我們持有 4.52 億美元的現金及約當現金。9 月與 10 月的需求讓我們對未來的需求與銷售走勢有了更清晰的視角。基於此，以及近期重組帶來的成本節省，我們目前預期現金餘額可支應營運至少至 2025 年第二季。我現在把電話交回給 Cedric 作結語。Cedric？

Thanks, Tim. This quarter was not without challenges, but we are now seeing a clear rebound in the growth and progress we accomplished earlier this year. We are on the cusp of expanding SYFOVRE's reach in global markets alongside steady growth in the PNH market with EMPAVELI. We remain dedicated to delivering on our strategic priorities and creating long-term shareholder value. Let us now open the call for questions. Operator?

謝謝，Tim。本季並非沒有挑戰，但我們現在看到今年稍早所達成的成長與進展正明顯回升。我們正處於擴大 SYFOVRE 在全球市場觸及範圍的關鍵時點，同時 EMPAVELI 在 PNH 市場也維持穩健成長。我們仍致力於落實策略重點並創造長期股東價值。現在讓我們開放提問。接線員？

(Operator Instructions)

（接線員指示）

And our first question coming from the line of Umer Raffat with Evercore.

我們的第一個問題來自 Evercore 的 Umer Raffat。

This is Jon Miller on. Maybe now that you've had some more commercial experience through all of the speculates stuff. Can you maybe update our assumptions on the difference between vials shipped and doses given? What proportion of doses are sitting in fridges at various places in your estimation? And then secondly, maybe on the etiology of vasculitis. Do you have any early signs out of the needle switch at this point? Is that really making an impact in rates? Or are there any suggestions of a patient risk profile that might identify patients ahead of time? Or has there been any motion on that front?

我是 Jon Miller。或許現在你們在經歷了那些推測性的事件之後，已累積更多商業化經驗。你們能否更新一下我們對「出貨的藥瓶數」與「實際施打的劑量數」之間差異的假設？依你們估計，有多少比例的劑量正放在各處的冰箱裡？第二個問題是關於血管炎的病因。就目前而言，你們是否已看到更換針頭的任何早期跡象？這是否真的對發生率產生影響？或者是否有任何跡象顯示某種患者風險特徵，能夠事先辨識患者？在這方面是否有任何進展？

Jon, great to hear you. I'm going to have the first question over to Adam, and then I'll take the second one.

Jon，很高興聽到你的聲音。第一個問題我先交給 Adam，第二個我來回答。

Jon, so first things first, I think we're extremely confident and pleased with the commercial execution. And let me give you a few numbers. So obviously, 37,000 commercial vials in the third quarter at about 10,000 samples. All of these vials were shipped to physicians. And we assume, based on our math, an average of about 1 to 1.5 weeks of demand vials sitting in a refrigerator. So we think we have over 100,000 injections since launch, about 50,000 patients being treated with SYFOVRE. I think it's a really strong commercial execution. So hopefully, that answers your question. And I'll hand back to Cedric for the second part.

Jon，首先，我們對商業執行非常有信心，也很滿意。我提供幾個數字。第三季商業出貨 37,000 瓶，另有約 10,000 瓶樣品。這些藥瓶都已出貨給醫師。依我們的計算，我們假設冰箱中平均約有 1 到 1.5 週需求量的庫存。因此我們認為自上市以來已完成超過 100,000 次注射，約有 50,000 名患者正在接受 SYFOVRE 治療。我認為這是非常強勁的商業執行。希望這回答了你的問題。接著我把第二部分交回給 Cedric。

Thank you, Adam. Then talking about etiology, so it is still too early, right? I mean, we're going to need probably another quarter or 2 to really understand whether the needle had an impact or not. But the most important metric here is that the rate of vasculitis is very low and stable, right, something that over the past couple of months, we've been able to track. And of course, it provides confidence to the physicians. So with more than 100,000 injections done in the real world, we are at a rate and continues to be at a rate of 0.01%. But it's, of course, also important to look into which patients have significant and severe vision loss. And there, the rates are meaningfully lower than 0.01% on a per injection basis. And using that metric with 50,000 patients treated, you're also still at a rate of 0.01%. So something that, of course, we hope to understand better in the future, but most importantly, stable and being followed over time.

謝謝你，Adam。接著談到病因，目前仍然太早，對吧？我們可能還需要再觀察一到兩個季度，才能真正了解針頭是否產生影響。但這裡最重要的指標是血管炎的發生率非常低且穩定，這是我們在過去幾個月能夠追蹤到的。當然，這也讓醫師更有信心。以真實世界已完成超過 100,000 次注射來看，我們的發生率為 0.01%，且仍維持在 0.01%。但同樣重要的是，也要看哪些患者出現顯著且嚴重的視力喪失；在那方面，以每次注射為基礎的發生率明顯低於 0.01%。而用 50,000 名已治療患者這個指標來看，發生率也仍是 0.01%。這當然是我們希望未來能更深入理解的事情，但最重要的是，它是穩定的，並且會隨時間持續追蹤。

And our next question coming from the line of Tazeen Ahmad with Bank of America.

下一個問題來自美國銀行（Bank of America）的 Tazeen Ahmad。

Just wanted to ask you a question about the competitive landscape, if I could. And how you think it's evolving. It looks like Astellas has reported $8 million for its first month on the market, and they are projecting about $72 million for their full calendar year, which I believe ends in March. So can you just talk about what feedback you're getting from field force about competition, whether it's increasing and where, if anywhere, you might be seeing patients switching. Thank you.

我想請教一下競爭格局的問題，以及你們認為它如何演變。看起來 Astellas 報告其上市首月收入為 800 萬美元，並預估其完整曆年（我相信其年度在 3 月結束）約為 7,200 萬美元。你們能否談談你們從一線團隊收到的競爭回饋，競爭是否在加劇、在哪些地方加劇，以及如果有的話，你們是否看到患者在轉換用藥？謝謝。

Thank you Tazeen. Great to hear you, Adam will take that question.

謝謝你，Tazeen。很高興聽到你的聲音，這題由 Adam 回答。

Yes. Thanks, Tazeen. So it's interesting. We hear firstly from analysts and investors, a lot of surveys done with physicians, where the sentiment that's given back to us is that these physicians are bullish on Izervay. It's different to what we hear in the field. It's been relatively quiet in the field. We're not hearing a lot of noise where we're really, really not hearing very much from the field. And I think if you look at our first 3 quarters, which is in line with their fiscal year reporting, we were $160 million in the first 3 quarters of launch. So that's a hugely successful launch. I think we are going to be laser-focused on executing our plan, which is to continue to talk about increasing effects over time, the strong clinical profile, long-term efficacy, dosing flexibility. And just to say, the vast majority of physicians are using SYFOVRE every 6 to 8 weeks. We have strong payer coverage, our J-code in October. I'm very confident that we will continue to show positive growth with SYFOVRE. So we're going to be focused on our plan. We execute our plan. I think we'll do incredibly well.

好的，謝謝，Tazeen。這很有意思。我們首先從分析師與投資人那裡聽到很多醫師調查，回饋給我們的情緒是醫師對 Izervay 很看多。但這與我們在第一線聽到的不太一樣；在第一線相對安靜。我們沒有聽到很多雜音，真的、真的沒有從第一線聽到太多。我想如果你看我們上市後的前三個季度（這與他們的會計年度揭露口徑一致），我們上市後前三個季度達到 1.6 億美元。這是一個非常成功的上市。我認為我們會高度聚焦、精準執行我們的計畫，也就是持續溝通隨時間增加的療效、強勁的臨床特徵、長期療效，以及給藥彈性。再補充一點，絕大多數醫師每 6 到 8 週使用一次 SYFOVRE。我們有強勁的支付方覆蓋，且我們在 10 月取得 J-code。我非常有信心 SYFOVRE 將持續展現正向成長。因此我們會專注於我們的計畫並執行它。我認為我們會做得非常好。

Okay. And maybe as a follow-up, Astellas is going to be showing a 24-month date, I believe, at the AAO conference this week, this weekend. And as it relates to every other month, what are physicians telling you about what they want to see on curve separation for every other month dosing.

好的。那我追問一下，Astellas 這週、這個週末在 AAO 會議上應該會展示 24 個月的數據。就隔月給藥而言，醫師告訴你們他們希望在隔月給藥的曲線分離（curve separation）上看到什麼？

Thank you, Tazeen. Caroline, would you like to answer that?

謝謝你，Tazeen。Caroline，你願意回答嗎？

Thank you. Physicians would like to see increasing effects over time. I think that's very important for them. And at the American Academy of Ophthalmology this weekend, we will be presenting our GALE data, the first year of the extension study where patients have received -- some of the patients have received 3 years of continuous pegcetacoplan therapy. I think physicians will be impressed by our data, and they also are impressed by the science that's behind pegcetacoplan. They like the flexibility with dosing with monthly and every other month dosing being meaningful and 3 years of data. And actually, the first patient will be -- patients will be rolling out of GALE this December. That's 5 years in the clinical study with continuous pegcetacoplan treatment. So we're really proud of that data.

謝謝。醫師希望看到隨時間增加的療效，我認為這對他們非常重要。在本週末的美國眼科學會（American Academy of Ophthalmology）年會上，我們將發表 GALE 數據，也就是延伸研究的第一年結果，其中部分患者已接受連續 pegcetacoplan 治療達 3 年。我認為醫師會對我們的數據印象深刻，他們也對 pegcetacoplan 背後的科學很認同。他們喜歡每月與隔月給藥所帶來的彈性，且 3 年數據具有意義。實際上，第一批患者將在今年 12 月從 GALE 研究中完成退出；那代表在臨床研究中連續接受 pegcetacoplan 治療達 5 年。因此我們對這些數據感到非常自豪。

And our next question coming from the line of Anupam Rama with JPMorgan.

下一個問題來自摩根大通（JPMorgan）的 Anupam Rama。

So in terms of physician use of SYFOVRE, back in the summer, you talked about this 1/3, 1/3, 1/3 breakdown when it comes to utilization. What is that breakdown now? And what are you seeing from those that were maybe previously in that 1/3 bucket that was on the sidelines or you're waiting for more information.

關於醫師對 SYFOVRE 的使用情況，今年夏天你們提到使用率大致呈現 1/3、1/3、1/3 的分布。現在這個分布如何？另外，對於先前可能屬於那個「觀望」或「等待更多資訊」的 1/3，你們看到他們有什麼變化？

Thank you, Anupam. Adam?

謝謝你，Anupam。Adam？

Yes. Thanks, Anupam. So obviously, the last update to our market research was in August. And that showed similar results as to the research that we shared on the Q2 call. Now I think we're super encouraged to see continued enthusiasm for SYFOVRE from physicians. We started to see new physicians start SYFOVRE, start new patients. And one metric I absolutely love. And I think it's been a really powerful metric for us is since launch, we have had double-digit numbers of new accounts signed for SYFOVRE for the first time every week, and that's continued since launch. That shows you a little bit of the sentiment of physicians that we're being transparent. We're sharing with them. We're being open, and I think it's driving the continued growth that you're seeing from our results.

好的，謝謝，Anupam。很明顯，我們上一次更新市場研究是在 8 月，結果與我們在第二季電話會議上分享的研究相近。現在我們非常受到鼓舞，因為看到醫師對 SYFOVRE 的熱情持續。我們開始看到新的醫師開始使用 SYFOVRE、開始治療新患者。有一個我非常喜歡、也一直是對我們很有力的指標：自上市以來，我們每週都有雙位數的新帳戶首次簽約使用 SYFOVRE，而且這種情況自上市以來一直持續。這讓你看到一些醫師的情緒：我們保持透明、與他們分享、保持開放，我認為這正在推動你從我們業績中看到的持續成長。

We have seen -- totally honestly, we've seen some physicians become a bit more conservative. For example, many physicians are now starting the worst eye first -- and also, they're not doing bilateral injections as their first interactions. We do still see bilateral injections being done, but they're being a bit more thoughtful in how they approach it. But the segments from the market research, we're making in grounds in each of those one third segments, I think we're really, really driving demand. And I think you're seeing the results of that in the number of patients that are choosing to use SYFOVRE.

我們已經看到——完全坦白地說，我們看到有些醫師變得稍微更保守一些。舉例來說，許多醫師現在會先從較嚴重的那隻眼開始——而且，他們不再把雙眼同時注射作為第一次的處置。我們仍然看到有在做雙眼注射，但他們在採取這種做法時更為審慎。不過，從市場調研的分群來看，我們在每一個三分之一的分群中都在取得進展，我認為我們確實、確實正在帶動需求。我想你也能從選擇使用 SYFOVRE 的患者人數中看到這些成果。

And our next question coming from the line of Colleen Kusy with Baird.

下一個問題來自 Baird 的 Colleen Kusy。

Colleen, I don't think we can hear you.

Colleen，我想我們聽不到你的聲音。

I will go onto the next question. Our next question coming from the line of Yigal Nochomovitz with Citigroup.

我將進入下一個問題。下一個問題來自 Citigroup 的 Yigal Nochomovitz。

I had one on IC-MPGN and C3G. So for that -- the standing you showed in the slide, was that an IC-MPGN patient or a C3G patient? And then more broadly, would you expect pegcetacoplan behave similarly in each indication? And then as regards to Valeant, could you talk about what level of proteinuria reduction would be considered clinically meaningful? And will there be any interim analysis of that trial before the 3Q '24 top line?

我有一個關於 IC-MPGN 和 C3G 的問題。就那個——你在投影片上展示的染色（staining），那是 IC-MPGN 病患還是 C3G 病患？另外更廣泛地說，你預期 pegcetacoplan 在這兩個適應症中的表現會相似嗎？再來關於 Valeant，你能談談蛋白尿降低到什麼程度會被視為具有臨床意義嗎？以及在 2024 年第三季（3Q '24）公布主要結果（top line）之前，該試驗會有任何期中分析嗎？

Thank you so much, Yigal, and thank you for that question. So that was a C3G patient that you saw that image from. And I cannot overemphasize how meaningful that histopath is, right? So just as a reminder for those that are not familiar with this. In C3G and IC-MPGN, you get a deposition of C3 covalently, so irreversibly attached to the cells in the glomerulus. For those deposits to go away, you need to have healthy cells that can actually internalize that C3 product and process it properly. So for us to see these improvements over the course of 3 months is actually really unbelievable. And this is in the post-transplant situation. So these are actually patients that were transplanted and that had a recurrence of the disease. So needless to say, really, really meaningful to this population. We see these effects both in C3G and in IC-MPGN. And again, as mentioned, this very important segment as well in the post-transplant setting.

非常感謝你，Yigal，也謝謝你的提問。你看到那張影像是來自一位 C3G 病患。我無法過度強調那個組織病理（histopath）有多麼重要，對吧？提醒一下不熟悉的人：在 C3G 和 IC-MPGN 中，會有 C3 的沉積，以共價鍵方式、因此不可逆地附著在腎小球的細胞上。要讓那些沉積消失，你需要健康的細胞，能夠真正把那個 C3 產物內吞並正確處理。因此，我們能在 3 個月的期間內看到這些改善，實際上非常令人難以置信。而且這是在移植後的情境下。所以這些其實是已接受移植、且疾病復發的患者。毋庸置疑，對這個族群而言非常、非常有意義。我們在 C3G 與 IC-MPGN 都看到了這些效果。而且如前所述，在移植後的情境中，這也是一個非常重要的族群。

As it relates to Valeant, there's not an interim readout. There's going to be a 6-month readout, and we will consider 50% reduction in proteinuria to be clinically meaningful.

至於 Valeant，沒有期中讀出。會有一個 6 個月的讀出，而我們會將蛋白尿降低 50% 視為具有臨床意義。

And our next question coming from the line of Steve Seedhouse with Raymond James.

下一個問題來自 Raymond James 的 Steve Seedhouse。

I had 3 questions on SYFOVRE. First is just on if you expect a label amendment at some point? And if so, would that include just retinavasculitis update? Or would you also look to add some GALE data or some of the visual function data that you noted? Second question is Astellas actually provided peak sales guidance as well, I think about USD 1.3 billion to USD 2.6 billion. Curious if you're modeling less similar or more for SYFOVRE. And then lastly, the 50,000 patients treated that you mentioned, I'm curious if you know or have a sense of how many are currently on treatment and can estimate that basically, therefore, how many discontinuations you had amid the RV disclosures, patients that you might be able to bring back to SYFOVRE?

我有 3 個關於 SYFOVRE 的問題。第一個是，你是否預期未來某個時間點會有標籤（label）修訂？如果會，是否只會包含視網膜血管炎（retinal vasculitis）的更新？還是也會考慮加入一些 GALE 的資料或你提到的一些視覺功能資料？第二個問題是，Astellas 也提供了峰值銷售額指引，我記得大約是 13 億到 26 億美元。想了解你們對 SYFOVRE 的建模是更低、相近，還是更高？最後，你提到已治療 50,000 名患者，我想知道你是否知道或能否估計目前仍在治療中的人數，從而推算在 RV 披露期間的停用（discontinuations）數量，以及你們可能可以把哪些患者帶回到 SYFOVRE？

Thank you so much, Steve. I will take the first question and then hand the other 2 over to Adam. As it relates to the label, so I think we should expect that there will be a label change and update at some point. I think it's noteworthy that it hasn't happened, which is again a reflection of the fact that we have a stable situation with a very rare event that I think the FDA, along with us is tracking before we get to a label change. So that's something to be followed as far as it relates to what it will be that, of course, we don't know yet. Adam, can you take the next thing?

非常感謝你，Steve。我先回答第一個問題，然後把另外兩個交給 Adam。關於標籤，我認為我們應該預期在某個時間點會有標籤變更與更新。值得注意的是目前尚未發生，這也再次反映出我們的情況是穩定的，且這是一個非常罕見的事件；我想 FDA 與我們一樣，在進行標籤變更之前都在追蹤這件事。所以這部分需要持續關注。至於最終會更新什麼內容，當然我們目前還不知道。Adam，你可以接著回答下一個嗎？

Yes. Thanks, Steve. So obviously, we don't guide, but we -- with 5 million GA patients worldwide, we think is a very sizable market. It's probably the best way of me answering that question. And then the third part of your question, of the 50,000 patients currently on SYFOVRE, we think discontinuations is very low at the moment. We obviously did see some discontinuations during the retinal vasculitis phase, but we think it's very low because it's early in launch. And I think if you look now as a metric in October, demand trajectory was back to July levels, -- so I think, again, I think we expect to see all of the new patients that are starting and all the continued patients to start to benefit from this treatment and try and stay on it, patients are incredibly motivated. But short answer is discons, we believe, are quite low during this time period, especially now we're back to the growth trajectory.

好的，謝謝你，Steve。很明顯我們不提供指引，但——全球有 500 萬名 GA 患者，我們認為這是一個非常可觀的市場；這大概是我回答那個問題的最佳方式。至於你第三個問題，在目前使用 SYFOVRE 的 50,000 名患者中，我們認為目前的停用率非常低。我們確實在視網膜血管炎那段期間看到一些停用，但我們認為目前非常低，因為上市初期仍在早期階段。而且我想如果你看 10 月的需求軌跡，已回到 7 月的水準——所以我想，再次強調，我們預期所有新開始治療的患者以及持續治療的患者，都會開始從這個治療中受益並嘗試持續使用；患者的動機非常強。簡而言之，我們相信在這段期間停用相當低，尤其是現在我們已回到成長軌跡。

Adam, just to clarify. So I think I missed it. So 50,000 is the current patients on typoreestimate?

Adam，我想確認一下。所以我想我漏聽了。50,000 是目前正在使用的患者數，對嗎？

Correct.

沒錯。

Our next question coming from Phil Nadeau with TD Cowen.

下一個問題來自 TD Cowen 的 Phil Nadeau。

A question is on the rate of vasculitis. Do you expect to present any updated rate or a number of cases at the AAO meeting this weekend? Do you expect ASRS to make a presentation on their evaluation of vasculitis this weekend? And then going forward, when could we expect future updates? Is there a cadence that you'd be willing to guide to like once a quarter or just at significant medical meetings or something like that?

我的問題是關於血管炎的發生率。你們是否預期在本週末的 AAO 會議上提出任何更新的發生率或病例數？你們是否預期 ASRS 會在本週末就其對血管炎的評估做簡報？另外往後，我們何時可以期待後續更新？你們是否願意提供一個更新節奏的指引，例如每季一次，或只在重要醫學會議上更新之類的？

Thank you, Phil. So I think what's really important here is that this rate is constant, is under control and has remained unchanged. I think that is really something. So we're going to stop talking about individual cases because, frankly, that's not an effort that we think is fruitful. To put this in perspective, the last case of a patient with geographic atrophy that was reported to us with vasculitis is already from September 1, right? So we had that case with a non-GA patient on September 22, but that's been it. So again, we keep tracking all of this. We will report on this if there are changes, but we are not going to do this on a case-by-case basis. Then as it relates to ASRS, Caroline can briefly speak to this because we've been collaborating very closely with them.

謝謝你，Phil。我認為這裡真正重要的是，這個發生率是固定的、在可控範圍內，且一直維持不變。我認為這點本身就很重要。因此我們將停止逐一討論個別病例，坦白說，我們不認為那是有成效的做法。為了讓大家有個概念：最後一例被回報給我們、且為地圖狀萎縮（geographic atrophy, GA）患者合併血管炎的病例，已經是 9 月 1 日的事了，對吧？我們在 9 月 22 日有一例非 GA 患者的病例，但之後就沒有了。所以再次強調，我們會持續追蹤所有這些情況。如果有變化我們會對外報告，但我們不會以逐案方式來做。至於 ASRS，Caroline 可以簡短說明，因為我們一直與他們非常密切合作。

Thank you, Cedric. We are in close communication with the ASRS Risk Committee and with regards to cases. And as far as we are aware, there will be no update at the American Academy. But we did provide an update at the Retina Society and at the Academy this weekend in addition to the GALE data, we'll be presenting some very meaningful microperimetry data as well as be having a presentation on artificial intelligence imaging and photoreceptor preservation from our study.

謝謝你，Cedric。我們與 ASRS 風險委員會就病例保持密切溝通。就我們所知，在美國眼科學會（American Academy）上不會有更新。不過，我們確實在 Retina Society 以及本週末的 Academy 會議上提供了更新；除了 GALE 資料之外，我們也將展示一些非常有意義的微視野檢查（microperimetry）資料，並且會有一場關於人工智慧影像與我們研究中光受體（photoreceptor）保存的報告。

And going forward, should we expect an update on the rate like once a quarter or any sense of when you'll provide updates?

那往後，我們是否應該期待例如每季一次的發生率更新？或你們大概何時會提供更新？

Well, we continue to remain transparent with physicians and everything that we receive is reported to the FDA as per regulations. And if that rate changes, we will update the community.

我們會持續對醫師保持透明，我們收到的所有資訊也都會依照法規回報給 FDA。如果該發生率有變化，我們會向社群更新。

Our next question is from Derek Archila with Wells Fargo.

下一個問題來自 Wells Fargo 的 Derek Archila。

Maybe just one on Europe. I guess how have your recent interactions with the EMA bid on the application? And just in terms of the market opportunity, maybe this is for Adam, do you think the overall adoption in the EU will be any different than the U.S.?

也許問一個關於歐洲的問題。我想知道你們最近與 EMA 就申請案的互動情況如何？另外就市場機會而言，這題可能給 Adam：你認為在歐盟的整體採用情況會與美國有任何不同嗎？

Thank you so much, Derek. So EMEA is on track and has continued to be on track. As we've mentioned a couple of times in the past, this has really -- has been a labor of love over many, many years of preparing the physician community as well as the regulators as well as the payers in Europe. And we're very excited about being able to offer this product, we believe, next year, right? So Adam, do you want to maybe briefly talk about the adoption.

非常感謝你，Derek。EMEA 的進度如期，並且一直維持在正軌上。正如我們過去提過幾次，這真的——是多年來的心血結晶：我們在歐洲長期投入，準備醫師社群、監管機構以及支付方。我們非常期待能夠提供這項產品，我們相信會是在明年，對吧？Adam，你要不要簡短談談採用情況。

Yes. Thanks, Derek. Thanks for the question. Yes. We are ready to go in terms of commercial and medical affairs infrastructure. So we're ready in Germany, right? So we are good to go once we get feedback. 5 million GA patients worldwide, Derek, obviously about 1 to 1.5 million in the U.S. So the rest is all ex U.S. So it's a very sizable opportunity. as a nice little analog, about 45% of sales of anti-VEGF drugs are ex U.S., right? So it's a sizable opportunity for us.

是的。謝謝你，Derek。謝謝你的提問。是的，就商業與醫療事務的基礎建設而言，我們已經準備就緒。所以我們在德國已經準備好了，對吧？因此一旦我們收到回饋，我們就可以立即推進。Derek，全球約有500萬名GA患者，顯然美國約有100萬到150萬名。因此其餘都在美國以外。這是一個非常可觀的機會。作為一個不錯的小類比，抗VEGF藥物的銷售約有45%來自美國以外，對吧？所以這對我們而言是個相當大的機會。

A few things to think about. Obviously, it's a payer market and a health technology assessment market and highly likely that -- for example, again, branded anti-VEGF prices are about 40% to 70% discount to the U.S. anti-VEGF prices. Even with that metric, this is a sizable opportunity. And the teams really invested the time to get to know the key opinion leaders. And we believe that being transparent as we were in the U.S., we've been with key opinion leaders and doctors ex U.S. We think that they have all of the information that they need. And should we get approval, I think the doctors will be ready to go very quickly.

有幾點可以思考。顯然，這是一個由支付方主導的市場，也是健康技術評估（HTA）市場，而且很可能——例如，再次強調，品牌抗VEGF的價格相較於美國的抗VEGF價格大約有40%到70%的折扣。即便以這個指標來看，這仍是一個可觀的機會。而團隊也投入大量時間去了解關鍵意見領袖。我們相信，正如我們在美國所做的那樣保持透明，我們也一直與美國以外的關鍵意見領袖與醫師交流。我們認為他們已經擁有所需的全部資訊。若我們獲得核准，我認為醫師將能非常迅速地開始使用。

Thank you. One moment for our next question. Our next question coming from the line of Eli Merle with UBS.

謝謝。請稍候，我們進行下一個問題。我們的下一個問題來自UBS的Eli Merle。

Just another on Europe. Can you just talk a little bit about how the review is going and the latest and your confidence on approval there? And then in terms of the feedback you've got on some physicians in Europe relative to the U.S., maybe on safety and their perspective. And then any commentary on what we should expect in terms of the contribution to revenues next year from Europe.

再問一個關於歐洲的問題。你能否談談審查進展如何、最新狀況，以及你們對於在那裡獲得核准的信心？另外，就你們從歐洲醫師那裡得到的回饋而言，相較於美國，可能在安全性及其觀點方面有何不同？最後，對於明年歐洲對營收的貢獻，我們應該預期什麼？

Okay. Thank you, Eli. Well, I'll take the first one, then I will have Caroline speak about the doctors on safety in Europe and then Adam can or Tim can talk about revenue. But again, European discussions have gone very well. As you all know, kind of correlation to functionality is very important in Europe. And as the data kind of comes together over time, now also with GALE, that is something that we feel very good about. Caroline, on the doctors in Europe?

好的。謝謝你，Eli。我先回答第一個，接著請Caroline談談歐洲醫師對安全性的看法，然後Adam或Tim可以談談營收。不過再次強調，歐洲的討論進展非常順利。如各位所知，在歐洲，與功能性的相關性非常重要。隨著數據隨時間逐步整合，現在也包含GALE，我們對此感到非常有信心。Caroline，關於歐洲的醫師呢？

The KOLs in Europe are very well connected with the U.S. KOLs. It's really a global community. Many of them were involved in the clinical study and have high confidence in our product and are familiar with its use. Also, they're really data-driven, and we have this visual function microperimetry data. We have key leaders in the U.S., but also in Europe on microperimetry who are impressed by this data and are looking forward to use of SYFOVRE.

歐洲的KOL與美國的KOL連結非常緊密。這其實是一個全球性的社群。許多人參與了臨床研究，對我們的產品很有信心，也熟悉其使用方式。此外，他們非常以數據為導向，而我們擁有這些視覺功能的微視野檢查（microperimetry）數據。我們在美國有關鍵領袖，但在歐洲也有在微視野檢查領域的關鍵領袖，他們對這些數據印象深刻，並期待使用SYFOVRE。

Thanks, Eli. And then in terms of revenue, ex U.S. is a very large proportion of potential future revenues. So with the anti-VEGF, we expect that -- we estimate that's around 45% of total revenue. It's actually more patients but less revenue per patient. In terms of next year, however, while we expect approval in the first quarter, really that rollout becomes sort of a country-type by-country basis, the first one being Germany. So we don't expect a huge amount of contribution next year, but we do expect we will be able to recognize revenue right after approval, which we expect in the first quarter.

謝謝你，Eli。至於營收方面，美國以外市場在未來潛在營收中占比非常大。因此以抗VEGF為例，我們預期——我們估計約占總營收的45%。實際上患者更多，但每位患者的營收較低。不過就明年而言，雖然我們預期在第一季獲得核准，但實際上市推廣將會以各國逐一推進，第一個是德國。因此我們不預期明年會有非常大的貢獻，但我們確實預期在核准後即可認列營收，而我們預期核准時間在第一季。

Thank you. Next question. And our next question coming from the line of Akash Tewari with Jefferies.

謝謝。下一個問題。我們的下一個問題來自Jefferies的Akash Tewari。

This is Ivy on for Akash. We have 2 questions. First, as you said in the prepared remarks on account receivables, which is at 17 million this quarter compared to $7 million at year-end. Could you maybe give us more visibility there? What's the current inventory level at the distributor's level? And the second is, I think someone already asked this, but today, I think competitors also announced their peak estimate of around $1.3 billion to CNY 2.6 billion, which seems quite conservative compared to numbers laid out in their proxy, which implies peak sales of around like CNY 4 billion in just the U.S. So curious what do you think may have with changes in saprogram on the geo market potential? And has your view changed at all?

我是Ivy，代Akash提問。我們有兩個問題。第一個，正如你在事先準備的發言中提到的應收帳款，本季為1,700萬美元，相較於年末的700萬美元。你能否提供更多能見度？目前在經銷商層級的庫存水位是多少？第二個，我想有人已經問過，但今天我認為競爭對手也宣布其峰值預估約為13億至26億人民幣，與他們在委託書（proxy）中列出的數字相比似乎相當保守；委託書暗示僅在美國的峰值銷售就約為40億人民幣。因此想請教，你認為在地理市場潛力方面，是否因為saprogram的變化而有所改變？你們的看法有任何改變嗎？

Thank you so much for that question. I will hand it over to Tim and then Adam.

非常感謝你的問題。我會先交給Tim，然後再由Adam補充。

Sure. The big change in accounts receivables relates to the fact that we have fairly extended but also market typical payment terms. So that receivable is primarily the distributors. In particular, the largest portion is for SYFOVRE. It's typical for a launch in this space, and we don't expect any issues in terms of collections. So it's just fairly typical. And I think you'll see that number increase slightly over time as sales increase. And then with respect to Astellas, I think it's hard for us to speculate why they've had that change. We obviously think this is a gigantic market. And anything that they do -- I mean, if you looked at their prepared remarks from what we saw, they said they're early in their launch, and they're still evaluating based on not only what they're seeing personally, but also what they're seeing from us. And I expect you will see that number evolve over time.

好的。應收帳款的主要變化與我們採用相對較長、但也符合市場慣例的付款條件有關。因此這些應收款主要來自經銷商，尤其最大的一部分是SYFOVRE。這在此領域的新產品上市中很典型，我們不預期在收款方面會有任何問題，所以這只是相當典型的情況。我認為隨著銷售增加，這個數字會隨時間略有上升。至於Astellas，我們很難推測他們為何做出那樣的變更。我們顯然認為這是一個巨大的市場。而他們所做的任何事——我的意思是，如果你看我們所看到的他們事先準備的發言，他們表示仍處於上市初期，仍在評估，不僅基於他們自身看到的情況，也基於他們從我們這裡看到的情況。我預期那個數字會隨時間演變。

Yes. And just to add to Tim's -- Avi it's Adam. Yes, we truly believe it's a large market, but it's also a market which is driven by certain aspects of a good product profile. So flexible dosing, increasing effects over time. So within a large market, we truly believe we have a very competitive product. It's an exciting opportunity to prevent and help patients vision over time worldwide. So we're excited to go and get after that.

是的。再補充Tim的——Avi，我是Adam。是的，我們確實相信這是一個很大的市場，但同時也是一個由良好產品特性所驅動的市場。因此像是彈性給藥、效果隨時間增強等。在一個龐大的市場中，我們確實相信我們擁有非常具競爭力的產品。這是一個令人振奮的機會，能在全球範圍內隨時間預防並幫助患者的視力。因此我們很期待全力以赴。

And our next question coming from the line of Annabel Samimy with Stifel.

我們的下一個問題來自Stifel的Annabel Samimy。

I had a couple. So I guess with the greater experience that physicians are having and more understanding of this rare event, do you notice a change in the way physicians are selecting their patients? I know that you had identified some low-hanging fruit initially. Have they become more selective in their use since those events? Or is the comfort level now increasing and are becoming a little bit more liberal with our use and maybe moving to less severe patients. So just a little bit of color around the type of patient selection physicians have. And then secondly, I was wondering if there's any moment where you'd be comfortable giving guidance on SYFOVREsales going forward?

我有幾個問題。首先，隨著醫師累積更多經驗、也更了解這個罕見事件，你們是否注意到醫師在選擇患者方式上的改變？我知道你們一開始提到有一些「低垂的果實」。在那些事件之後，他們在使用上是否變得更有選擇性？或者現在舒適度正在提高，使用上變得更為寬鬆，甚至可能轉向病情較不嚴重的患者？所以想請你們多分享一些醫師在患者選擇類型上的情況。第二，我想知道是否有任何時點，你們會願意對未來SYFOVRE銷售提供指引？

Thank you so much, Annabel.

非常感謝你，Annabel。

Thank you. I think physicians are very enthusiastic about SYFOVRE, and they understand, whenever we present about the large robust data set that we have and the clinical findings, they understand the science and that's really what drives them. What we have seen is that physicians may be a little more conservative than they were in the beginning, for example, not treating both eyes first visit or starting with the worse eye first, which is not uncommon from intravitreal injections, but they are very comfortable now with the technique of drop of the product, which is slightly thicker, and they have continued their use with enthusiasm. Adam, do you have anything to add to that?

謝謝。我認為醫師對SYFOVRE非常熱情，而且每當我們展示我們所擁有的大型且強健的數據集與臨床發現時，他們都能理解其科學基礎，而這正是驅動他們的因素。我們看到的是，醫師可能比一開始稍微保守一些，例如第一次就不治療雙眼，或先從較差的那隻眼開始，這在玻璃體內注射並不少見；但他們現在對於滴入本產品（質地稍微較稠）的技術已非常熟悉，並且持續以熱情使用。Adam，你有要補充的嗎？

Yes. Thanks for the question, Annabel. Just to add to Caroline's comments, right? I think -- you saw the graph in the presentation and in October, we're seeing demand trajectory eclipse and back to the July levels, right? And one thing I love about this is that we're seeing new patients come on to SYFOVRE every week. And that to me is a really solid signal of confidence. I gave this metric earlier. I'll give it again because it excites me. It's -- every week since launch, we've had double-digit new accounts start and order SYFOVRE for the first time. And I think that's a very positive, positive thing. And now with the J-code, I expect us to continue to drive that. But as Caroline said, it was a little bit of a pause in terms of how people use the drug, and I think we're starting to make in-roads that confidence is coming back into the community.

是的。謝謝你的問題，Annabel。補充Caroline的評論，對吧？我想——你在簡報中的圖表也看到了，10月我們看到需求軌跡已超越並回到7月的水準，對吧？而我很喜歡的一點是，我們每週都看到有新患者開始使用SYFOVRE。對我而言，這是一個非常扎實的信心訊號。我之前提過這個指標，我再說一次，因為這讓我很興奮——自上市以來，每一週都有兩位數的新帳戶開始並首次下單SYFOVRE。我認為這是一個非常、非常正面的事情。而且現在有了J-code，我預期我們會持續推動這一點。但如Caroline所說，在人們如何使用這個藥物方面曾有一段小小的停頓，而我認為我們正開始取得進展，信心正在回到這個社群之中。

Sure. And I'll just jump in on guidance. I don't know when we plan to give any guidance. What I will say is that if you'd ask me where we were 3 months ago and where we are today, I'm really excited. And I think the more we can get the next couple of quarters under our feet, we'll have a really good sense of where we are. I don't know when we'll actually give guidance. It's something we haven't committed to, but we'll let you know when we have a decision on that.

當然。我也想直接補充一下關於財測指引（guidance）。我不確定我們計畫何時會提供任何指引。我想說的是，如果你問我 3 個月前我們在哪裡、以及今天我們在哪裡，我真的感到非常振奮。我認為只要我們能把接下來幾個季度更穩健地走過，我們就會對自身所處位置有非常好的掌握。我不確定我們實際上何時會給出指引。這是我們尚未承諾的事情，但一旦我們對此作出決定，我們會告知各位。

(Operator Instructions) Our next question coming from Douglas Tsao with H.C. Wainwright.

（接線員指示）下一個問題來自 H.C. Wainwright 的 Douglas Tsao。

I guess, Adam, I wanted to touch on something that you commented, and we've talked about it before in terms of patient interest and demand. I'm just curious, how are you trying to overcome perhaps physician -- I don't want to say resistance to sort of hesitation to start treatment for any number of reasons, be safety or some stocks aren't necessarily fully convinced on the efficacy in the face of sort of trying to get patients to get treated, right? Because it seems like sometimes an talking to doctors, they speak about patient enthusiasm, and they say that they're sort of trying to pump the brakes on their patients? And how are you trying to sort of get docs to ease up on that? Or is it a matter of time to just redirect patients to doctors who are more readily treating with SYFORVE.

我想，Adam，我想談談你提到的一點，我們之前也談過，關於病患興趣與需求。我只是好奇，你們如何嘗試克服醫師可能的——我不想說是抗拒，而是對於出於各種原因而開始治療的猶豫，可能是安全性，或有些醫師未必完全相信療效，尤其是在推動病患接受治療的情況下，對吧？因為有時候和醫師交談時，他們會提到病患很熱衷，但他們說自己反而在對病患「踩煞車」？你們如何讓醫師在這方面放鬆一些？或者這只是時間問題，讓病患轉向那些更願意使用 SYFORVE 治療的醫師？

Yes. Thanks, Doug, for the question. So yes, interestingly, prelaunch of SYFORVE, we did -- we spent a lot of time with GA patients, and they were super enthusiastic about our potential treatment. They used to give us anecdotes like I want to spend time with my grandkids and be able to read to them and all of those type of activities. That has not changed since launch. This is a very driven patient population. We're obviously doing some commercial activities to help patients flag that they may have vision impairment and they should go and see a retina physician or an ophthalmologist or an optometrist through our TV and radio campaign with Henry Winkler.

是的。謝謝你，Doug，這個問題。確實很有意思，在 SYFORVE 上市前，我們——我們花了很多時間與 GA 病患交流，他們對我們潛在的治療非常熱情。他們常跟我們分享一些軼事，例如「我想花時間陪孫子孫女，能夠讀書給他們聽」，以及這類活動。自上市以來，這點沒有改變。這是一群非常有動力的病患族群。我們當然也在做一些商業推廣活動，協助病患注意到自己可能有視力受損，並應該去看視網膜專科醫師、眼科醫師或驗光師；這是透過我們與 Henry Winkler 合作的電視與廣播宣傳活動。

I think that's had a very positive impact in the market. That has driven patients into physicians. We've also started to see that physicians can now have a benefit risk discussion with these patients, and the patient motivation has an impact on that prescribing physician. So we'll continue to do more activities to drive patients. We have found that if some physicians are, for whatever reason, not injecting that these patients will seek other physicians that are. So that's happening within the market. But this is a highly, highly motivated patient population and it meets an incredibly good discussion of highly motivated physician conversation.

我認為這對市場帶來了非常正面的影響，並把病患帶進醫師端。我們也開始看到，醫師現在可以與這些病患進行效益—風險（benefit-risk）的討論，而病患的動機會影響開立處方的醫師。因此我們會持續做更多活動來帶動病患。我們發現，如果某些醫師因為任何原因不進行注射，這些病患會去尋找其他願意注射的醫師。所以市場上確實正在發生這種情況。但這是一個高度、非常高度有動力的病患族群，也促成了與高度有動力的醫師之間非常良好的對話。

Great. And if I can ask one follow-up. I know there's been a lot of focus on the third, third, third sort of market research that you had talked about from the summer. I'm just curious to your sense of the third who had sort of stopped using or weren't using -- do you think some of those were dispositions or how many of them were just doctors just for whatever reason, were never going to be big users. And so that you're sort of right now sort of really sort of hitting a good part of the sort of truly receptive market.

很好。如果我可以再追問一個問題。我知道大家一直很關注你們提到的、夏季那份市場研究中所說的「三分之一、三分之一、三分之一」。我只是想了解你對於那個已經停止使用或沒有使用的三分之一的看法——你覺得其中有些是既定立場（dispositions）嗎？或者其中有多少醫師只是因為某些原因，本來就不會成為大量使用者？因此你們現在其實正切入真正願意接受的市場核心部分。

Yes. Thanks, Doug. So again, if I jump back to pre-SYFORVE launch, we always had a segment of physicians who said, "I'm not going to use your drug until the permanent J-code. So there was an assumption of 1/3, 1/3, 1/3 that, that segment has said, we're not going to use your drug basically also included those physicians who were waiting for the J-code. So I think we potentially will see an impact within that segment and have seen an impact within that segment in the last quarter. I think the more transparent we can be, the more open we can be, but also now we're pushing our efficacy message with physicians. I think it unlocks all of those segments. And we started to see those segments unlocked with the strong demand levels that we've had since -- for this quarter and moving forward. So I think it's going to be a very positive next couple of quarters.

是的。謝謝你，Doug。所以再回到 SYFORVE 上市前，我們一直都有一個醫師族群表示：「在永久 J-code 出來之前，我不會用你們的藥。」因此當時有一個 1/3、1/3、1/3 的假設，而那個表示基本上不會使用我們藥物的族群，也包含了那些在等待 J-code 的醫師。所以我認為我們可能會在那個族群中看到影響，而且在上一季也確實看到一些影響。我認為我們越透明、越開放，同時我們現在也在向醫師端推進我們的療效訊息，我覺得這會解鎖所有那些族群。我們也開始看到，隨著本季以及未來持續強勁的需求水準，這些族群正在被解鎖。所以我認為接下來幾個季度會非常正面。

Congrats on the progress.

恭喜你們的進展。

Thank you.

謝謝。

Our next question coming from the line of Joseph Stringer with Needham.

下一個問題來自 Needham 的 Joseph Stringer。

Just following up on the last 2 questions for the physicians who are not currently injecting SYFORVE for safety reasons. Is your sense that the rate of vasculitis is a sticking point? Or is it more physicians are comfortable with the rate and it's more a matter of they want to see the total number of patients or the total number of injections a lot higher before they would start injecting? And is there a threshold number of patients or injections that they would need to see to get more comfortable if that is the case before injecting?

我想延續前兩個問題，對於目前因安全性原因而尚未注射 SYFORVE 的醫師，你們的感覺是血管炎（vasculitis）的發生率是一個卡點嗎？還是說醫師其實對這個發生率是可以接受的，只是他們希望在開始注射前，先看到更多的總病患數或總注射次數？如果是後者，是否存在一個他們需要看到的病患數或注射次數門檻，才能更安心並開始注射？

Yes. I think, Joey -- thank you so much for the question. It's important to bear in mind that this rate in itself was never an issue, right? I mean the problem that we had is that a couple of years ago, there was another drug that started with this rate and ended up with a rate that was orders of magnitude worse because there was a sensitization against the drug. This is absolutely not the case here. So this is an extremely rare event sporadically over time. And as I mentioned, we're going to keep tracking that, but it is a very straightforward conversation now between the physician and the patient. Adam can maybe comment briefly on the commercial impact of that.

是的。我想，Joey——非常感謝你的問題。重要的是要記住，這個發生率本身從來都不是問題，對吧？我的意思是，我們遇到的問題是，幾年前有另一個藥物一開始也是這樣的發生率，但後來因為對藥物產生致敏（sensitization），發生率惡化到高出好幾個數量級。這裡絕對不是這種情況。所以這是一個極其罕見、隨時間零星發生的事件。如我提到的，我們會持續追蹤，但現在醫師與病患之間的對話已經非常直接。Adam 也許可以簡短評論一下這對商業面的影響。

Yes. Thanks, Joey. So no surprise, takeout vasculitis for the conversation for a second. Every launch has a subset of physician population that I would deem as laggards, right? Those that -- it's a technical term they wait to see what happens with the drug once it launches. They follow key opinion leaders, they follow that experience. It doesn't matter if you're launching a drug in the retina or launching a drug in another space that subset of physician population exists. It's the same within this launch, right? So we had physicians who said "I would wait for the permanent J-code." We've had physicians who said, "I want to see that Professor X or Dr. Y is using and has good experience before I start." So as we get through the launch trajectory, we expect to unlock all of those segments. As those physicians who are waiting will get the check in the box that they need to say I've seen enough. I understand this now. My colleagues are using, I'm going to start to use it. So it's a future opportunity. I think we'll continue to make inroads within that segment.

是的。謝謝你，Joey。所以不意外，先把血管炎這個議題暫時從對話中拿掉。每一次新產品上市，都會有一部分醫師族群，我會稱之為落後採用者（laggards），對吧？那些——這是個技術用語——他們會等到藥物上市後看看會發生什麼。他們會追隨關鍵意見領袖（KOL），追隨那些使用經驗。不管你是在視網膜領域推出藥物，或是在其他領域推出藥物，這一類醫師族群都存在。這次上市也是一樣，對吧？所以我們有醫師說：「我會等永久 J-code。」也有醫師說：「我想先看到 X 教授或 Y 醫師在用、且有良好經驗，我才會開始。」因此，隨著我們走過上市的軌跡，我們預期會解鎖所有這些族群。那些等待的醫師會得到他們需要的「打勾確認」，也就是：我看得夠多了，我現在理解了，我的同儕在用，我也要開始用。所以這是未來的機會。我認為我們會持續在那個族群中取得進展。

And I see no further questions in the Q&A queue at this time. I will now turn the call back over to Dr. Cedric Francois for any closing remarks.

我看到目前 Q&A 等候序列中沒有其他問題。我現在把電話交回給 Cedric Francois 醫師作結語。

Thank you so much. Well, in closing, thank you all for joining us today. We are around later today and tomorrow. If you have any additional questions, feel free to reach out to Meredith. Thank you again, and have a wonderful day.

非常感謝。那麼在結語部分，謝謝各位今天加入我們。我們今天稍晚以及明天都會在。如果你們有任何其他問題，歡迎聯絡 Meredith。再次感謝，祝各位有美好的一天。

This concludes today's conference call. Thank you for your participation. You may now disconnect.

今天的電話會議到此結束。感謝各位的參與。您現在可以掛線。