Apellis Pharmaceuticals Inc (APLS) 2025 Q2 法說會逐字稿

Good day, and welcome to the second-quarter 2025 Apellis Pharmaceuticals, Inc. earnings conference call. (Operator Instructions) Please be advised that today's conference is being recorded.

大家好，歡迎參加 Apellis Pharmaceuticals, Inc. 2025 年第二季財報電話會議。（操作員指示）請注意，今天的會議正在錄音。

I would now like to hand the conference over to your speaker, Tracy Vineis, Vice President of Communications. Please go ahead.

現在，我想將會議交給發言人、通訊副總裁 Tracy Vineis。請繼續。

Good morning and thank you for joining us to discuss Apellis' second-quarter 2025 financial results. With me on the call are Co-Founder and Chief Executive Officer, Dr. Cedric Francois; Chief Financial Officer, Tim Sullivan; Chief Medical Officer, Dr. Caroline Baumal; and Executive Vice President of Commercial, David Acheson.

早安，感謝您加入我們討論 Apellis 2025 年第二季的財務表現。與我一起參加電話會議的還有共同創辦人兼執行長 Cedric Francois 博士、財務長 Tim Sullivan、首席醫療官 Caroline Baumal 博士以及商務執行副總裁 David Acheson。

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.

在我們開始之前，請允許我指出，我們將根據我們當前的期望和信念做出前瞻性的陳述。這些聲明受一定風險和不確定性的影響，實際結果可能有重大差異。我鼓勵您查閱我們提交給美國證券交易委員會的文件中討論的風險因素以獲取更多詳細資訊。

Now I'll turn the call over to Cedric.

現在我將把電話轉給塞德里克。

Thank you, Tracy. As many of you know, Apellis is a pioneering biopharmaceutical company with two approved C3-targeting medicines, SYFOVRE and EMPAVELI, both the blockbuster potential and the pipeline of innovative therapies. We are focused on treating diseases with high unmet needs by targeting C3 to central protein in the complement cascade and the only target that addresses all three activation pathways that can initiate and strike disease.

謝謝你，特蕾西。眾所周知，Apellis 是一家先鋒生物製藥公司，擁有兩種已批准的 C3 標靶藥物 SYFOVRE 和 EMPAVELI，既具有重磅藥物潛力，也擁有創新療法的研發管線。我們專注於透過將 C3 靶向補體級聯中的中心蛋白來治療高度未滿足需求的疾病，並且這是唯一能夠解決引發和打擊疾病的所有三種活化途徑的靶點。

Earlier this week, the FDA approved a label expansion for EMPAVELI for the treatment of patients 12 years and older with C3 myelopathy or primary immune complex-membranoproliferative glomerulonephritis. This marks our third FDA approval in just four years, a significant milestone that reflects the strength of our science and our ability to deliver for patients.

本週早些時候，FDA 批准了 EMPAVELI 的標籤擴展，用於治療 12 歲及以上的 C3 脊髓病或原發性免疫複合物膜增生性腎小球腎炎患者。這是我們在短短四年內第三次獲得 FDA 批准，這是一個重要的里程碑，反映了我們的科學實力和為患者提供服務的能力。

Importantly, this approval represents a breakthrough for patients as for the first time, they can be treated with a C3 targeting therapy and one that achieves the trifecta of outcomes across all three key markers of these diseases including proteinuria reduction, eGFR stabilization, and substantial clearance of C3G deposits. It also advances care for several underserved populations that previously had no approved treatments, including pediatric patients with C3G, primary IC-MPGN patients 12 years and older, and patients with post-transplant C3G disease recurrence. The launch is now underway, and we are excited to make this transformative medicine available to patients as we expand into rare nephrology.

重要的是，這項批准對患者來說是一個突破，因為他們第一次可以接受 C3 標靶治療，而該療法可在這些疾病的所有三個關鍵標記物上實現三重療效，包括減少蛋白尿、穩定 eGFR 和大量清除 C3G 沉積物。它還為幾個以前沒有獲得批准治療的服務不足人群提供了先進的護理，包括患有 C3G 的兒科患者、12 歲及以上的原發性 IC-MPGN 患者以及移植後 C3G 疾病復發的患者。目前該產品的上市工作正在進行中，隨著我們向罕見腎臟病學領域擴展，我們很高興能夠讓患者享受這種變革性的藥物。

Moving then to SYFOVRE performance. We continued to see steady demand growth in the second quarter. Total injections, including commercial and free goods grew by 6% quarter over quarter, delivering SYFOVRE revenues of $151 million. SYFOVRE remains the clear market leader in GA with 55% of new patient starts during the quarter, and total market share exceeding 60%.

然後轉到 SYFOVRE 效能。我們在第二季繼續看到需求穩定成長。包括商業和免費商品在內的總注入量較上季成長 6%，為 SYFOVRE 帶來 1.51 億美元的收入。SYFOVRE 仍然是 GA 的明顯市場領導者，本季新患者數為 55%，總市佔率超過 60%。

Commensurate with the headwinds we saw in the first quarter, we do continue to see high levels of free goods usage in connection with the funding shortage at the copay-assistance programs. The market opportunity in GA is significant with SYFOVRE market leadership, strong patent life, meaningful potential for growth, and a low likelihood of new market entrants in the next few years, we have confidence in the long-term potential of SYFOVRE.

與我們在第一季看到的逆風相稱的是，我們確實繼續看到與共同支付援助計劃的資金短缺相關的免費商品使用率很高。憑藉 SYFOVRE 的市場領導地位、強大的專利壽命、巨大的成長潛力以及未來幾年新市場進入者的可能性較低，GA 的市場機會十分巨大，我們對 SYFOVRE 的長期潛力充滿信心。

During the second quarter, we also gained significant operational flexibility through our Aspaveli capped royalty purchase agreement with Sobi. This transaction reflects our shared confidence in the meaningful growth potential in rare kidney diseases. With a strong cash position to substantial growth opportunity for Aspaveli, SYFOVRE continued market leadership, and a maturing pipeline, we are well positioned for success going forward.

在第二季度，我們還透過與 Sobi 簽訂的 Aspaveli 上限特許權使用費購買協議獲得了顯著的營運彈性。此次交易反映了我們對罕見腎臟病領域巨大成長潛力的共同信心。憑藉強大的現金狀況、Aspaveli 的巨大成長機會、SYFOVRE 持續的市場領導地位以及日益成熟的產品線，我們為未來的成功做好了準備。

With that, I will now turn over the call to Tim to provide a review of the financials from the second quarter. Tim?

說完這些，我現在將電話轉給提姆，讓他回顧第二季的財務狀況。提姆？

Thank you, Cedric. Total revenue for the second quarter was $178 million, including SYFOVRE net product revenue of $151 million. Utilization of SYFOVRE free goods remained high during the second quarter and impacted revenue by approximately $13 million. We expect a similar impact to quarterly revenue throughout the rest of 2025. We delivered over 95,000 doses of SYFOVRE the quarter, including 82,000 commercial doses, and 13,000 free goods dosing.

謝謝你，塞德里克。第二季總營收為 1.78 億美元，其中 SYFOVRE 淨產品收入為 1.51 億美元。第二季度，SYFOVRE 免費商品的使用率仍然很高，對收入產生了約 1,300 萬美元的影響。我們預計 2025 年剩餘時間內的季度營收也將受到類似的影響。本季我們交付了超過 95,000 劑 SYFOVRE，其中包括 82,000 劑商業劑量和 13,000 劑免費商品劑量。

SYFOVRE injection demand grew 6% during the quarter. Looking ahead to the rest of the calendar year, we expect quarter-over-quarter injection growth to be in the low to mid-single digits, consistent with the growth trajectory of the last two quarters. Over the longer term, we aim to accelerate growth with several key initiatives that David will speak to shortly.

本季 SYFOVRE 注射劑需求增加了 6%。展望今年剩餘時間，我們預期季度環比注資成長率將達到低至中等個位數，與過去兩季的成長軌跡一致。從長遠來看，我們的目標是透過幾項關鍵舉措來加速成長，David 很快就會談到這些舉措。

EMPAVELI Valley continues to elevate the standard of care in PNH. Revenue in the second quarter was $21 million, up 5% quarter over quarter. Patient compliance rates remained at 97%. We expect EMPAVELI to begin generating meaningful revenue from the C3G and primary IC-MPGN opportunities in the fourth quarter of 2025.

EMPAVELI Valley 繼續提高 PNH 的護理標準。第二季營收為2,100萬美元，季增5%。患者依從率仍維持在97%。我們預計 EMPAVELI 將在 2025 年第四季開始從 C3G 和主要 IC-MPGN 機會中獲得可觀的收入。

Turning now to the capped royalty purchase agreement with Sobi. This transaction reflects both parties shared confidence in the blockbuster potential of this product in exchange for 90% of future ex-US Aspaveli royalties up to the cap, Apellis received a $275 million cash upfront. Apellis is also eligible to receive $25 million in milestones upon their European Medicines Agency approval of Aspaveli in C3G and primary IC-MPGN. Defined caps tied to Aspaveli performance allow Apellis to participate in long-term upside.

現在來談談與 Sobi 達成的封頂特許權使用費購買協議。這筆交易體現了雙方對該產品巨大潛力的信心，Apellis 以未來美國以外 Aspaveli 特許權使用費的 90%（最高限額）作為交換，獲得了 2.75 億美元的預付現金。一旦歐洲藥品管理局批准 Aspaveli 用於治療 C3G 和原發性 IC-MPGN，Apellis 還有資格獲得 2500 萬美元的里程碑付款。與 Aspaveli 表現掛鉤的定義上限使 Apellis 能夠參與長期上漲。

Once these caps are achieved, all royalties refer to Apellis. These deal terms provide validation of the potential for meaningful growth in C3G and primary IC-MPGN. This purchase agreement does not affect the regulatory and commercial milestones of Apellis is eligible to receive under our 2020 agreement with Sobi.

一旦達到這些上限，所有版稅都歸 Apellis 所有。這些交易條款驗證了 C3G 和主要 IC-MPGN 具有有意義的成長潛力。該購買協議不會影響 Apellis 根據我們與 Sobi 達成的 2020 年協議有資格獲得的監管和商業里程碑。

We have maintained a highly disciplined approach to cost management while prioritizing the commercialization of SYFOVRE and EMPAVELI. Operating expenses were $212 million in the second quarter versus $229 million in the second quarter of 2024. We continue to expect our 2025 operating expenses to be in line with 2024 OpEx.

我們在優先實現 SYFOVRE 和 EMPAVELI 商業化的同時，也一直保持著高度嚴謹的成本管理方法。第二季營運費用為 2.12 億美元，而 2024 年第二季營運費用為 2.29 億美元。我們仍預期 2025 年的營運費用將與 2024 年的營運支出保持一致。

We ended the quarter with $370 million in cash and cash equivalents. We expect this cash combined with the $275 million payment from the royalty purchase transaction and future product sales will be sufficient to fund the business to sustainable profitability.

本季末，我們的現金和現金等價物為 3.7 億美元。我們預計，這筆現金加上特許權使用費購買交易支付的 2.75 億美元以及未來的產品銷售將足以支持該業務實現可持續盈利。

I will now hand the call over to Caroline for an update on our medical activities. Caroline?

現在我將把電話交給卡羅琳，讓她報告我們的醫療活動的最新情況。卡洛琳？

Thanks, Tim. With SYFOVRE as the leader in geographic atrophy and three diseases now approved for treatment with EMPAVELI, we have validated our conviction in targeting C3 as the optimal way to control complement mediated diseases. With the launch underway in C3G and primary IC-MPGN, we are planning the next phase of our strategy to maximize the potential with EMPAVELI. With a proven ability to control complements with targeting C3, we are expanding EMPAVELI development into two other rare kidney diseases, delayed graft function or DGF and primary focal segmental glomerulosclerosis, FSGS.

謝謝，蒂姆。SYFOVRE 是地圖狀萎縮治療領域的領導者，目前有三種疾病已獲準使用 EMPAVELI 治療，我們已證實我們的信念：針對 C3 是控制補體介導疾病的最佳方法。隨著 C3G 和主要 IC-MPGN 的推出，我們正在規劃策略的下一階段，以最大限度地發揮 EMPAVELI 的潛力。憑藉透過靶向 C3 來控制補體的能力，我們正在將 EMPAVELI 開發擴展到另外兩種罕見腎臟疾病，即移植功能延遲或 DGF 和原發性局部節段性腎小球硬化症 (FSGS)。

Similar to C3G, FSGS is a rare kidney disease that progresses to kidney failure within 5 to 10 years for about half of patients. DGF is a complication in kidney transplantation, where the transplanted kidney fails. Most patients are forced to go on to dialysis, which negatively affects the long-term survival of the kidney and overall patient outcomes. The complement pathway plays a significant role in both diseases and there are currently no FDA-approved therapies for either. We remain on track to begin with pivotal trials in DGF and FSGS by the end of the year.

與 C3G 類似，FSGS 是一種罕見的腎臟疾病，大約一半的患者會在 5 至 10 年內發展為腎衰竭。DGF 是腎移植的一種併發症，會導致移植的腎臟衰竭。大多數患者被迫進行透析，這對腎臟的長期存活和患者的整體預後產生負面影響。補體途徑在這兩種疾病中都發揮著重要作用，目前還沒有 FDA 批准的治療方法。我們仍有望在今年年底前開始對 DGF 和 FSGS 進行關鍵試驗。

We are also focused on the development of a next-generation treatment for geographic atrophy. I'm pleased to share that we have initiated a Phase 2 study evaluating the combination of SYFOVRE and our SiRNA APL-3007. With APL-3007 ability to lower complement levels systemically and SYFOVRE's well-established ability to inhibit complement in the retina, we believe we can improve efficacy with fewer injections. I look forward to sharing more on our exciting progress in the coming quarters.

我們也致力於開發下一代地圖樣萎縮的治療方法。我很高興地告訴大家，我們已經啟動了第 2 階段研究，評估 SYFOVRE 和我們的 SiRNA APL-3007 的組合。由於 APL-3007 能夠系統性地降低補體水平，而且 SYFOVRE 具有抑制視網膜補體的明確能力，我們相信我們可以透過更少的注射來提高療效。我期待在接下來的幾季分享更多我們令人興奮的進展。

I'll now turn the call over to our Executive Vice President of Commercial, David Acheson.

現在我將把電話轉給我們的商業執行副總裁 David Acheson。

Thank you, Caroline, and good morning, everyone. Following approval and the outstanding broad label we received from the FDA, I'd like to start with EMPAVELI and the launch in C3G and primary IC-MPGN. The initial response has been gratifying, and we have already seen activity from both patients and the treatment community. In the US, we estimate there are approximately 5,000 C3G in primary IC-MPGN patients. Notably, EMPAVELI broad label makes it the first treatment approved for pediatric patients with C3G, primary IC-MPGN patients aged 12 years and older, and patients with post-transplant C3G disease recurrence.

謝謝你，卡羅琳，大家早安。在獲得 FDA 的批准和出色的廣泛標籤後，我想從 EMPAVELI 開始，並在 C3G 和主要 IC-MPGN 中推出。最初的反應是令人滿意的，我們已經看到患者和治療界的積極行動。在美國，我們估計原發性 IC-MPGN 患者中約有 5,000 名 C3G。值得注意的是，EMPAVELI 的廣泛標籤使其成為首個獲準用於治療 C3G 兒科患者、12 歲及以上原發性 IC-MPGN 患者以及移植後 C3G 疾病復發患者的治療方法。

We expect EMPAVELI to become the preferred treatment option across all C3G and primary IC-MPGN patients on its way to blockbuster status. By the end of the year, we expect to transition approximately [50] C3G and IC-MPGN patients who are receiving EMPAVELI as part of our early access program or EAP to commercial growth.

我們預計 EMPAVELI 將成為所有 C3G 和原發性 IC-MPGN 患者的首選治療選擇，並有望成為重磅藥物。到今年年底，我們預計大約 [50] 名接受 EMPAVELI 治療的 C3G 和 IC-MPGN 患者將作為我們早期獲取計劃或 EAP 的一部分轉向商業增長。

Furthermore, we know there are some patients and physicians who are awaiting the approval of EMPAVELI that are expected to generate early demand. Beyond this, we expect traditional rare disease launch dynamics where there have historically been few or no approved treatments. More broadly, we are excited about this opportunity for growth. We are executing on three pillars to maximize the potential of EMPAVELI in these diseases.

此外，我們知道有些患者和醫生正在等待 EMPAVELI 的批准，預計會產生早期需求。除此之外，我們預計傳統的罕見疾病將迎來上市動力，因為歷史上很少或根本沒有批准的治療方法。更廣泛地說，我們對這一成長機會感到興奮。我們正在執行三大支柱，以最大限度地發揮 EMPAVELI 在這些疾病方面的潛力。

First, raise awareness about the availability of EMPAVELI as a disease-modifying therapy that targets the underlying cause of disease. This approval represents a breakthrough for patients and for the first time, they can be treated with a C3 targeting therapy.

首先，提高人們對 EMPAVELI 作為針對疾病根本原因的疾病改良療法的可用性的認識。此項批准對患者來說是一個突破，他們首次可以接受 C3 標靶治療。

Second, our goal is to establish EMPAVELI as the treatment of choice among nephrologists. We plan to leverage the outstanding clinical data in support of this approval. Our goal is for physicians and patient communities to equate early use of EMPAVELI with the preservation of kidney function and long-term disease control.

其次，我們的目標是將 EMPAVELI 確立為腎臟科專家的首選治療方法。我們計劃利用出色的臨床數據來支持此項批准。我們的目標是讓醫生和患者群體將早期使用 EMPAVELI 與保留腎功能和長期控制疾病聯繫起來。

Third, we are working to secure broad access as soon as possible. We care deeply for patients and are committed to ensuring that every patient who may benefit from EMPAVELI has access to treatment. This includes helping patients with reimbursement processes, disease education, and product support. We have been very successful in increasing disease awareness through our strong presence in physician offices and medical conferences and look forward to updating you on our progress.

第三，我們正在努力盡快實現廣泛准入。我們非常關心患者，並致力於確保每位可能受益於 EMPAVELI 的患者都能接受治療。這包括幫助患者完成報銷流程、疾病教育和產品支援。透過在醫生辦公室和醫學會議上的大力參與，我們在提高疾病意識方面取得了巨大成功，並期待向您通報我們的進展。

Switching now to SYFOVRE and the GA market. We are encouraged to see continued market leadership with injection growth of 6% during the quarter. However, revenue continued to be impacted by elevated use of free goods. We are working closely with drug offices to educate on best practices for managing patient access and reimbursement processes. As Tim already mentioned, our expectation for the rest of 2025 is for low to mid-single-digit injection growth, consistent with the growth we've seen in the first half of this year.

現在轉向 SYFOVRE 和 GA 市場。我們欣喜地看到，本季注射量成長 6%，並持續保持市場領先地位。然而，免費商品使用量的增加繼續影響著收入。我們正在與藥品辦公室密切合作，以教育管理患者獲取和報銷流程的最佳實踐。正如蒂姆已經提到的，我們對 2025 年剩餘時間的預期是低至中等個位數的注入增長，與我們今年上半年看到的增長一致。

Now moving to our key strategic objectives, growing the GA market and maintaining our leadership. Last quarter, I talked about some of our field initiatives to drive demand and new patient starts. We continue to execute on these disease awareness education on the importance of treating GA early and effectively remains a major focus for us. Many retina specialists take a wait-and-see approach when treating GA patients. There is a disconnect between physician perceptions of GA and the functional impact patients experienced. We're working to close this gap.

現在轉向我們的關鍵策略目標，擴大 GA 市場並保持我們的領導地位。上個季度，我談到了我們為推動需求和新患者開始治療而採取的一些現場措施。我們將繼續進行這些疾病意識教育，強調早期有效治療 GA 的重要性，這仍然是我們關注的重點。許多視網膜專家在治療 GA 患者時採取觀望態度。醫生對 GA 的看法與患者所經歷的功能影響之間存在脫節。我們正在努力縮小這一差距。

Next, we are expanding our engagement within the clinical community to educate the optometrists and ophthalmologists who manage a significant proportion of patients. We have prioritized engaging with these physicians to raise awareness about GA and the benefits of SYFOVRE treatment. Our efforts include directing them to our physician finder tool, which provides a list of retina specialists who have recently had experienced using SYFOVRE. Finally, we continue to leverage our highly successful DTC campaign to secure awareness and activating the patient base to seek treatment.

接下來，我們將擴大我們在臨床社區的參與度，以教育管理大量患者的驗光師和眼科醫生。我們優先與這些醫生合作，以提高他們對 GA 和 SYFOVRE 治療益處的認識。我們的努力包括將他們引導至我們的醫生查找工具，該工具提供了最近使用過 SYFOVRE 的視網膜專家清單。最後，我們繼續利用我們非常成功的 DTC 活動來提高意識並激活患者群體尋求治療。

Turning to competitive dynamics and our continued market leadership, SYFOVRE is the clear market leader by any measurable metric, revenue, new patient share, overall market share, commercial vials, total injections, preferred payer coverage, and presence at academic conferences.

談到競爭動態和我們持續的市場領導地位，SYFOVRE 在任何可衡量的指標、收入、新患者份額、整體市場份額、商業小瓶、總注射量、優先付款人覆蓋範圍以及在學術會議上的出席率方面都是明顯的市場領導者。

Our gains on new patient share reflects an understanding of SYFOVRE's differentiated profile, specifically, SYFOVRE is the only GA product to demonstrate robust and increasing effects over time. SYFOVRE is the only GA product approved for a few of six doses per year. SYFOVRE is the only product in a preferred position with many payers.

我們對新病患份額的提升反映了對 SYFOVRE 差異化特徵的理解，具體而言，SYFOVRE 是唯一一款能夠隨著時間推移而展現出強勁且不斷增強的效果的 GA 產品。SYFOVRE 是唯一獲準每年註射六劑的 GA 產品。SYFOVRE 是唯一一款受到眾多付款人青睞的產品。

And finally, we have five outstanding data presentations at the ASRS conference this week. We expect this newly published data on SYFOVRE's unique ability to preserve retina tissue over time to further different SYFOVRE and build on our market leadership. I look forward to reporting on our progress on our third quarter call.

最後，本週的 ASRS 會議上我們有五個精彩的數據演示。我們期望這些關於 SYFOVRE 獨特的長期保存視網膜組織能力的新發布數據能夠進一步改變 SYFOVRE 並鞏固我們的市場領導地位。我期待在第三季電話會議上報告我們的進展。

Let me now turn the call back to Cedric.

現在讓我把電話轉回給塞德里克。

Thanks, David. Before we close out the call, I am excited to also share two key leadership appointments that mark an important new chapter for Apellis. We are pleased to welcome Dr. Leslie Meltzer as our new Chief Research and Development Officer. Leslie comes to us from Orchard Therapeutics and is an experienced biopharma leader with a proven track record of advancing therapies from early-stage research through regulatory approval and commercialization. She will officially joined Apellis on August 25.

謝謝，大衛。在我們結束通話之前，我很高興地分享兩項重要的領導任命，這標誌著 Apellis 的重要新篇章。我們很高興歡迎 Leslie Meltzer 博士擔任我們的新任首席研發長。Leslie 來自 Orchard Therapeutics，是一位經驗豐富的生物製藥領導者，在推動療法從早期研究到監管部門批准和商業化方面擁有良好的記錄。她將於8月25日正式加入Apellis。

We also recently welcomed Kelley Boucher as our new Chief People Officer. Kelley joins us from Alnylam, where she served as Chief Human Resources Officer. Over her six-year tenure, she made a pivotal role in shaping Alnylam into a top-tier biotech company consistency recognized for its outstanding workplace culture. Please join me in warmly welcoming both Kelley and Leslie to the Apellis team.

我們最近也歡迎凱利·布歇 (Kelley Boucher) 擔任我們的新任首席人力資源長。凱利 (Kelley) 在加入 Alnylam 之前，曾擔任該公司首席人力資源長。在她六年的任期內，她在將 Alnylam 打造成為頂級生物科技公司方面發揮了關鍵作用，並始終以其出色的工作場所文化而聞名。請和我一起熱烈歡迎 Kelley 和 Leslie 加入 Apellis 團隊。

The first half of 2025 has been a period of success for Apellis, and we look forward to continuing this in the second half of this year. So with that, I'll turn the call over to the operator for Q&A.

2025 年上半年對 Apellis 來說是成功的時期，我們期待在今年下半年繼續保持這種成功。因此，我將把電話轉給接線員進行問答。

(Operator Instructions) Jon Miller, Evercore.

（操作員指示）Jon Miller，Evercore。

On the progress. I'd love to ask about the GA market since we just had a kidney call. But I guess your competitor is talking about 20%-plus quarter-on-quarter growth. They're talking about majority market share as well. They confirmed that they're also using insurance claims to generate their supposedly majority market share.

正在進行。我很想詢問有關 GA 市場的情況，因為我們剛剛接到一個腎臟電話。但我猜你的競爭對手正在談論 20% 以上的季度環比增長。他們也在談論大部分市場份額。他們證實，他們也在利用保險索賠來獲取所謂的多數市場份額。

So I wonder if you could just help me square that circle a little bit. It feels like your growth in the mid-single digits is good, but that's not what they're expecting. Your market share looks great, but again, this discordant with what they're expecting. So can you help me understand how you guys are getting to different results on the overall market potential here?

所以我想知道您是否能幫我稍微解決這個問題。感覺你的成長在個位數中間就很好了，但這並不是他們所期望的。您的市場份額看起來很棒，但這與他們的預期不一致。那麼你能幫助我了解你們是如何在整體市場潛力上取得不同成果的嗎？

Thank you so much, Jonathan. Great hearing you. So we have clear leadership to be clear on every single metric. On revenue, new patient share, overall market share on vials and injections, on preferred payer coverage, and also the presence at academic conferences. I mean we're here at ASRS in Long Beach. We have five volume presentations, our competitor has zero, right?

非常感謝，喬納森。很高興聽到你的聲音。因此，我們有明確的領導來明確每一個指標。關於收入、新患者份額、小瓶和注射劑的整體市場份額、優先付款人覆蓋範圍以及學術會議的出席情況。我的意思是我們現在在長灘的 ASRS。我們有五卷演示文稿，而我們的競爭對手卻沒有，對嗎？

So I think it's really important to point out also that the data that has been presented is still -- is by now four years old, and it's still the one-year data because of the second year, (inaudible) in the first year.

因此，我認為還需要指出的是，所提供的數據仍然是四年前的數據，而且由於第二年（聽不清楚）是第一年，所以它仍然是一年的數據。

So these are things that we need favor us. And I think the quality of the data, especially what came out after four years of treatment in the GALE extension with SYFOVRE is something that really resonates with the retina community.

所以這些都是我們需要的對我們有利的東西。我認為數據的質量，特別是在 SYFOVRE 的 GALE 擴展治療四年後得出的數據，確實引起了視網膜界的共鳴。

So look, also, I think it's important to note that the way in which we track and measure the competitive dynamics is on a much larger database sets than what our competitor uses. Ours is representative of approximately 50% of injections in the offices, whereas our competitor estimates their presence on approximately 10% with database dates.

所以，我認為值得注意的是，我們追蹤和衡量競爭動態的方式是基於比我們的競爭對手使用的更大的資料庫。我們的注射量佔辦公室注射量的約 50%，而我們的競爭對手根據資料庫日期估計，辦公室注射量佔約 10%。

So I think, look, at the end of the day, it comes down to the meaningfully differentiated efficacy profile that we have that is starting to resonate with the retina community and the continued evaluation scientifically asset of what SYFOVRE can do for patients. And that is really gratifying to see because, again, it's a full four years of data that we can analyze for SYFOVRE with the benefit and the increasing effects over time continue to stand out.

所以我認為，歸根結底，這取決於我們所擁有的有意義的差異化功效概況，它開始引起視網膜界的共鳴，以及對 SYFOVRE 能為患者做些什麼的持續科學評估。看到這一點確實令人欣慰，因為我們可以分析 SYFOVRE 整整四年的數據，其益處和隨著時間的推移不斷增強的效果持續顯現。

Anupam Rama, JPMorgan.

摩根大通的 Anupam Rama。

I was wondering if you could comment a little bit more on some of the sampling trends you saw in the quarter. I know last year, you said it's been -- last quarter, you said it was going to be about a similar amount. It looks like there's a little bump here on an absolute basis. So maybe just providing a little bit more color on how you're thinking about moving forward.

我想知道您是否可以對本季看到的一些採樣趨勢發表更多評論。我知道去年，您說過—上個季度，您說過這將是一個類似的金額。從絕對意義上看，這裡似乎有一個小的顛簸。因此，也許只是提供一些關於你如何考慮未來發展的更多資訊。

Thank you. Anupam, great hearing you, and I will hand the question over to David Acheson.

謝謝。Anupam，很高興聽到您的提問，我將把這個問題交給 David Acheson。

Thank you very much for the question. Appreciate it. As you would suspect, as we continue to grow the business quarter over quarter with the injections, you're going to continue to see some additional growth as we continue to play through the situation with the foundation funding, where we'll -- we could potentially see at or close to the same levels of the 13 million in samples that we saw in Q2 and that's why we have a little bit of the (inaudible).

非常感謝您的提問。非常感謝。正如您所料，隨著我們透過注資逐季成長業務，您將繼續看到一些額外的成長，因為我們將繼續利用基金會的資金來解決這個問題，我們可能會看到或接近第二季度 1300 萬個樣本的水平，這就是為什麼我們有一點（聽不清楚）。

So the business continues to grow and the injections and the demand is there, which is very positive. And I'm very encouraged by that. As we work through the rest of this year, I think we'll see similar trends.

因此業務持續成長，注入和需求都存在，這是非常積極的。我對此感到非常鼓舞。隨著我們度過今年剩餘的時間，我認為我們會看到類似的趨勢。

Yigal Nochomovitz, Citigroup.

花旗集團的 Yigal Nochomovitz。

I had a question on FSGS with regard to your Phase 3 plans. As you know, there's been a lot of work regarding endpoints in FSGS, including PARASOL Working Group that has determined that proteinuria was a very good proxy for eGFR slope. I'm wondering if you can comment with respect to what your plans are on endpoints for the FSGS trial

我對您的第 3 階段計劃中的 FSGS 有一個疑問。如您所知，關於 FSGS 終點已經有很多研究，包括 PARASOL 工作小組已確定蛋白尿是 eGFR 斜率的非常好的替代指標。我想知道您是否可以評論一下您對 FSGS 試驗終點的計劃

Thank you so much, Yigal. And thank you for that question. So obviously, we are going to be in the slipstream, if you want to call it, of the PARASOL group work. And it's a trial we're very excited about. We're still planning to enroll or start enrollment in that trial in the second half of this year. But we believe that the mechanism, the target engagement of EMPAVELI in the kidney and what we can do on a differentiation basis, we certainly look forward to.

非常感謝，伊加爾。感謝您的提問。因此，顯然，我們將處於 PARASOL 小組工作的尾流之中（如果您願意這麼稱呼的話）。我們對這次試驗感到非常興奮。我們仍計劃在今年下半年招募或開始招募該試驗。但我們相信，EMPAVELI 在腎臟中的機制、目標參與以及我們在差異化基礎上所能做的事情，都是我們所期待的。

Okay. And if I could just put one follow-up. Regarding the free goods, in prior quarters, you'd referenced samples for SYFOVRE. Is it fair to assume that the samples are sort of subsumed within free goods? Or are they different or the same? It's a little unclear as far as the terminology.

好的。如果我只能提出一個後續問題。關於免費商品，在前幾個季度，您曾參考過 SYFOVRE 的樣品。是否可以將樣品視為免費商品？或者它們不同或相同？就術語而言，有點不清楚。

Thank you go, Yigal. David will elaborate on that.

謝謝你，伊加爾。大衛將對此進行詳細說明。

Thanks for the question, by the way. You're right. It's basically a terminology shift that we've made. We've included both samples and the PAT program or patient assistance program in free goods to capture all of the figures that are being used in the marketplace.

順便說一句，謝謝你的提問。你說得對。這基本上是我們所做的術語轉變。我們在免費商品中加入了樣品和 PAT 計劃或患者援助計劃，以捕捉市場上使用的所有數據。

Salveen Richter, Goldman Sachs.

薩爾文·里克特，高盛。

This is (inaudible). Congratulations for the quarter. So you've mentioned that the expectation of QoQ injection growth in the low to mid-single digits. Is this a conservative estimate? And when do you expect to see an expansion for this growth rate?

這是（聽不清楚）。恭喜本季。所以您提到，預計季度注射量成長率將在低到中等個位數之間。這是一個保守的估計嗎？您預計何時會看到這一成長率的擴大？

Yes. Thank you so much for that question. I think the most important aspect here to bear in mind is that we -- with SYFOVRE, we are now having a stable business with steady and gradual growth, right? And that is something that allows us to really continue to work on the many, many patients that haven't been treated yet, continue to educate the retina community. And again, I want to point out that between the two products on the market, a little over 10% of patients have been treated so far.

是的。非常感謝您提出這個問題。我認為這裡要記住的最重要的方面是，我們——有了 SYFOVRE，我們現在擁有穩定的業務並穩步、逐步地成長，對嗎？這使我們能夠繼續為許多尚未接受治療的患者提供治療，並繼續教育視網膜界。我想再次指出，目前市面上的兩種產品中，只有略高於 10% 的患者得到了治療。

There's a long way to go. But most importantly, we are now in quite a stable situation, something that we look forward to taking advantage of.

還有很長的路要走。但最重要的是，我們現在處於相當穩定的局勢，我們期待利用這一點。

Steve Seedhouse, Cantor.

史蒂夫‧西德豪斯 (Steve Seedhouse)，領唱。

This is Timur Ivannikov on for Steve. So for Q2, could you talk about the factors that drove higher SYFOVRE revenue with similar commercial doses quarter over quarter? And also to follow up on Yigal's question, out of 13,000 free injections, how many were samples for new patients versus help, assistance to existing patients?

我是 Timur Ivannikov，代替史蒂夫報道。那麼對於第二季度，您能否談談推動 SYFOVRE 營收季增且商業劑量相似的因素？另外，為了回答 Yigal 的問題，在 13,000 次免費注射中，有多少是給新病患的樣品，有多少是給現有病患的幫助和援助？

Yeah. Thank you for the question, appreciated. This is David. So a couple of quick points there. So a little less than half of the growth that we saw was attributed to the free goods of the samples.

是的。謝謝您的提問，非常感謝。這是大衛。這裡有幾個要點。因此，我們所看到的增長中略少於一半的份額歸功於樣品的免費贈送。

So that's a specific data that we can pull on our free goods program. When it comes to the growth or the -- I guess, the first part of your question around sample usage and where that played out against the quarter over quarter kind of the growth that as we saw overall, obviously, we've got great demand as thrilled with that and continue to see quarter-over-quarter growth and samples are part of that.

這是我們可以在免費商品計劃中提取的特定數據。談到成長或——我想，您問題的第一部分是關於樣品的使用情況，以及與季度環比增長相比的情況，正如我們所看到的，顯然，我們對此感到非常興奮，並且繼續看到季度環比增長，樣品就是其中的一部分。

So yes, we saw the trend that was pretty -- was consistent between the commercial and trade vials, but we're also seeing true demand and patients getting started on the product through our sampling and our (inaudible) programs.

所以是的，我們看到了相當一致的趨勢——商業和貿易小瓶之間的趨勢是一致的，但我們也看到了真正的需求，患者透過我們的採樣和我們的（聽不清楚）計劃開始使用該產品。

Colleen Kusy, Baird.

科琳·庫西，貝爾德。

Just on the ongoing disruption of the third-party co-pay systems, is there anything that you're hearing on that? And any expectations on that in the near future? And then maybe one longer-term question, if I can. For the GALE long term extension study for C3G, IC-MPGN, and obviously, we've seen some good data from GALE that's helped us understand the differentiation of SYFOVRE. Any expectations for the GALE data going forward and how that might differentiate EMPAVELI, and C3G, and IC-MPGN.

關於第三方共同支付系統正在發生的中斷，您聽到什麼消息嗎？近期對此有何期待？如果可以的話，我可能還會問一個長期問題。對於 C3G、IC-MPGN 的 GALE 長期擴展研究，顯然，我們已經從 GALE 中看到了一些很好的數據，這些數據幫助我們了解 SYFOVRE 的差異。對未來的 GALE 資料有何預期，以及如何區分 EMPAVELI、C3G 和 IC-MPGN。

Thank you so much, Colleen. So look, there are evolving things happening at the foundation level for us. The way we think about these organizations is they are wonderful for patients, of course, we have supported them in the past, and we will continue to support them. So that is something that we are obviously very much in favor of.

非常感謝，科琳。所以你看，我們的基礎層面正在發生著不斷發展的事情。我們認為這些組織對患者來說非常好，當然，我們過去一直支持他們，我們將繼續支持他們。因此，我們顯然非常贊成這一點。

And then as it relates to the second part of your question -- could you repeat that because (inaudible).

然後，關於你問題的第二部分──你能重複嗎？因為（聽不清楚）。

On the GALE data, anything we can expect from that and how that will differentiate EMPAVELI versus its competitor in C3G, IC-MPGN.

關於 GALE 數據，我們可以期待什麼，以及這將如何區分 EMPAVELI 與其在 C3G、IC-MPGN 領域的競爭對手。

Thank you. I will hand it over to Caroline.

謝謝。我會把它交給卡洛琳。

Thanks, Colleen. Well, we got -- we are really thrilled with what we've seen for EMPAVELI and the recent approval and label for C3G and IC-MPGN. And I think what really differentiates us is that we achieved this trifecta of positive outcomes across the three key disease markers, reduce proteinuria, eGFR stabilization, and the robust substantial clearance of C3 deposits in the kidney.

謝謝，科琳。嗯，我們得到了——我們對 EMPAVELI 以及最近獲得的 C3G 和 IC-MPGN 的批准和標籤感到非常興奮。我認為我們真正的與眾不同之處在於，我們在三個關鍵疾病標記上都取得了積極成果，即減少蛋白尿、穩定 eGFR 以及強勁清除腎臟中的 C3 沉積物。

And what we're really excited about is that these effects continued on to the GALE extension study, which, of course, from -- runs with scale, which is what we use for ophthalmology. But so we continue to see these effects. And even more important, physicians are so excited about this data. We're hearing a lot of positive imput from (technical difficulty)

我們真正興奮的是，這些影響延續到了 GALE 擴展研究中，當然，該研究是從規模運行的，這也是我們在眼科研究中所使用的。但我們仍然看到這些影響。更重要的是，醫生們對這些數據感到非常興奮。我們聽到了很多正面的回饋（技術難度）

Akash Tewari, Jefferies.

Akash Tewari，傑富瑞。

This is Kathy on for Akash. Given the current SYFOVRE trajectory as of now, it seems like the class isn't expanding into a broader community center setting. So what's the right amount of OpEx spend for the (inaudible) franchise going forward? And given the current business trajectory, when do you think SYFOVRE will reach profitability?

我是 Kathy，代表 Akash。鑑於目前 SYFOVRE 的發展軌跡，該課程似乎不會擴展到更廣泛的社區中心環境。那麼，未來特許經營的適當營運支出是多少？鑑於目前的業務發展軌跡，您認為 SYFOVRE 何時能夠獲利？

Thank you so much for that question. I'll hand it over to David.

非常感謝您提出這個問題。我會把它交給大衛。

Yeah. So look, I will tell you, and I think we just need to take a step back for a second and remind ourselves how big this market is and the potential opportunities to meet a lot of unmet needs for a lot of patients that live with GA today. So I think it's important to keep that in note.

是的。所以，我告訴你，我認為我們只需要退一步思考一下，提醒自己這個市場有多大，以及為當今許多患有 GA 的患者滿足許多未滿足需求的潛在機會。所以我認為記住這一點很重要。

I also think it's super important to go back to what Cedric just talked about. We believe we are now in a very stable market. and we anticipate that will have stable, steady, gradual growth. And right now, we've got about 10%-plus of the market that's currently treated. So the market opportunity still exist. And we think long term, this is still a blockbuster product in the space.

我還認為回顧塞德里克剛才談論的內容非常重要。我們相信我們現在處於一個非常穩定的市場。我們預期市場將會穩定、穩定、逐步成長。目前，我們已經佔據了大約 10% 以上的市場份額。因此市場機會仍然存在。我們認為，從長遠來看，這仍然是該領域的重磅產品。

David, this is Tim Sullivan. I'll just jump in for one second. SYFOVRE is one of our business lines. So we have obviously EMPAVELI, we have development, we have Discovery. If you're looking for whether or not SYFOVRE alone is profitable, on its own, it's a very profitable business.

大衛，我是提姆‧沙利文。我只想跳進去一秒鐘。SYFOVRE 是我們的業務線之一。因此，我們顯然有 EMPAVELI，有發展，有發現。如果您想知道 SYFOVRE 本身是否盈利，那麼就其本身而言，它是一項非常有利可圖的業務。

It's high leverage with a reasonable sales force. And you can also see in our 10-Q, we do show on an R&D basis, what is allocated to G&A. So you can make a P&L for SYFOVRE alone that shows it's a profitable business.

合理的銷售團隊帶來高槓桿。您也可以在我們的 10-Q 中看到，我們確實在研發基礎上顯示了分配給 G&A 的內容。因此，您可以單獨為 SYFOVRE 製作一份損益表，以表明這是一項盈利業務。

Divya Rao, TD Cowen.

Divya Rao，TD Cowen。

This is Divya on for Phil. Based on your discussions with physicians, I'm curious if you get the sense that the competitor label expansion in February has impacted prescribing patterns now that we have about like one full quarter with the new label.

這是 Divya 為 Phil 主持的節目。根據您與醫生的討論，我很好奇您是否認為 2 月份競爭對手的標籤擴展已經影響了處方模式，因為現在我們已經使用新標籤大約一個季度了。

And then if I can, a quick one on EMPAVELI. What might be the specific launch metrics we can expect for the launch in C3G over the next few quarters?

然後，如果可以的話，我想快速談談 EMPAVELI。未來幾季，我們可以預期 C3G 推出的具體發布指標是怎麼樣的？

Thank you so much for that question. I will briefly comment on our competitors' CRL, and (inaudible) we move in February, and then I will hand the second part of your question over to David.

非常感謝您提出這個問題。我將簡要評論我們競爭對手的 CRL，並且（聽不清楚）我們將在二月份採取行動，然後我將把你的問題的第二部分交給大衛。

So I think the most important aspect of the CRL that was issued to our competitor in November is the fact that it's kind of truly called out the fact that there was a limitation on that initial level of one year, something that a lot of physicians are not aware of. And then the fact that every other month dosing was reviewed by the FDA as a treatment that works for this product.

因此，我認為 11 月向我們的競爭對手發布的 CRL 最重要的方面是，它確實指出了一年這一初始等級的限制，而許多醫生並沒有意識到這一點。事實上，每隔一個月的劑量給藥已被 FDA 審查為適用於該產品的治療方法。

So I think that in terms of reputation, this was very important for retina specialists to understand and know. And from all the data that we see, that is not something that we have recovered from. Caroline, I don't know if you want to expand on that?

所以我認為，就聲譽而言，視網膜專家了解和知道這一點非常重要。從我們看到的所有數據來看，我們還沒有從這種損失中恢復過來。卡洛琳，我不知道你是否想進一步闡述這一點？

Just adding that, we have a very -- SYFOVRE has flexible label with every other month dosing, which has been well studied in our clinical study as well as in our expansion study. And we're currently at ASRS with bioquodium presentation, we will continue to have robust data that data-driven retina physicians really need to treat their patients best. And all of this helped with patient compliance team and every other month is much more reasonable, and this really speaks to the broadness of SYFOVRE overviews.

補充一點，我們有一個非常靈活的標籤——SYFOVRE，每隔一個月給藥一次，這在我們的臨床研究和擴展研究中都得到了充分的研究。目前，我們正在 ASRS 進行 bioquodium 演示，我們將繼續擁有可靠的數據，以數據驅動的視網膜醫生確實需要這些數據來最好地治療他們的患者。所有這些都有助於患者合規團隊，每隔一個月的收費更加合理，這確實說明了 SYFOVRE 概述的廣泛性。

David, do you want to comment? Can you repeat the second part of your question about C3G?

大衛，你想發表評論嗎？您能重複一下有關 C3G 的問題的第二部分嗎？

Yeah. I was just curious if there was any specific launch metrics we can expect over the next few quarters just help the launch is going for EMPAVELI.

是的。我只是好奇，我們是否可以預期未來幾季內會出現任何具體的發布指標，以幫助 EMPAVELI 的發布。

Yeah. No, great question. Thank you for that. So our specific focus, and what we'll lay out for you will be the transition that we've got for our EAP patients, which is in motion already as of this week in our (inaudible) patients. And then we will look at star forms that will be where we spend our time reporting out. And then also REMS, we'll work through REMS enrollments on the physician side.

是的。不，這個問題問得好。謝謝你。因此，我們的具體重點以及我們將為您介紹的是我們為 EAP 患者進行的轉變，從本週起，我們的（聽不清楚）患者已經開始了這一轉變。然後，我們將觀察星體形態，並花時間進行報告。然後還有 REMS，我們將透過醫生方面的 REMS 註冊開展工作。

Over time, what we'd like to do is transition it over to actual patients on product. But it's early, right? We're three days post the Austin label coming out from the FDA. And it's going to take us a little time to get active data coming in that we can continue to attract and consistent with. So we want to make sure we get a little more time before we do that.

隨著時間的推移，我們希望將其轉化為產品的實際患者。但現在還早，對吧？奧斯汀標籤從 FDA 出來已經三天了。我們需要花一點時間來獲取可以繼續吸引和保持一致的活躍數據。因此，我們希望確保在這樣做之前能有更多的時間。

Eliana Merle, UBS.

瑞銀的 Eliana Merle。

This is Jasmine on for Ellie. So I wanted to follow up on the patient assistance funding dynamics going forward. Specifically, can you talk about what you expect from the impact of the Regeneron donation matching to good days? And do you think that seeing some funding return can potentially lower the usage of free drug that you see in the coming quarters?

這是 Jasmine 為 Ellie 演唱的。所以我想跟進患者援助資金未來的動態。具體來說，您能否談談您對再生元捐款匹配對美好日子的影響的預期？您是否認為，看到一些資金回報可能會降低未來幾季免費藥物的使用量？

And then just secondly, can you talk about the latest you're seeing in compliance and adherence for SYFOVRE?

其次，您能談談您對 SYFOVRE 合規性和依從性的最新看法嗎？

Yes. Thank you so much for that question. So look, on the foundations, again, I think the most important element there, as I mentioned earlier, is that this is something that is important for patients. the way in which they manage their money, the way in which it gets allocated the way which it does get funded, something that we are completely independent from for us, it's a medical decision to help and assist these foundations to help patients. So we have done that in the past. We will continue to do that.

是的。非常感謝您提出這個問題。所以，再看看基金會，我認為最重要的因素，正如我之前提到的，是這對病人來說很重要。他們管理資金的方式，資金的分配方式，資金的獲得方式，這些都是我們完全獨立的事情，對我們來說，幫助和協助這些基金會幫助病人是一個醫療決定。我們過去也這樣做過。我們將繼續這樣做。

As far as compliance is concerned, I will hand that question over to Caroline.

至於合規性問題，我會將這個問題交給卡洛琳。

Thank you, Cedric. I think that of course, there's things that might affect patient compliance like the patient foundations. But overall, physicians from large (inaudible) work groups are reporting compliance and it's been about 80%, depending on which physician group, patients are motivated to be treated, especially with their experienced persistent vision. David, do you have anything to add?

謝謝你，塞德里克。我認為，當然有些因素可能會影響患者的依從性，例如患者基礎。但總體而言，大型（聽不清楚）工作小組的醫生報告的依從性約為 80%，取決於哪個醫生組，患者有動力接受治療，尤其是他們所經歷的持續視力。大衛，你還有什麼要補充的嗎？

No.

不。

Lachlan Hanbury-Brown, William Blair.

拉克蘭·漢伯里·布朗，威廉·布萊爾。

I guess can you just talk to the progress you've made with the benefits investigation process for the patients that were previously getting assistance and obviously, no longer I think last call, you said that was maybe 20% of patients. Has that -- have you sort of been able to make a dent in that 20% of patients, especially in line the fact that commercial vials was sort of flat?

我想您能否談談針對先前獲得援助的患者在福利調查過程中所取得的進展，顯然，現在不再是了，我想上次您說的那大概佔患者的 20%。您是否能夠對那 20% 的患者產生影響，尤其是考慮到商用小瓶藥物已經變得扁平？

Yes, Lachlan. Apologies, but we can't really hear what you're saying. Can you repeat this?

是的，拉克蘭。抱歉，我們聽不清楚您在說什麼。你能重複一遍嗎？

Is this better?

這樣好些了嗎？

Yes, please go ahead.

是的，請繼續。

I was wondering if you could talk to the process that you -- the progress that you've had with the benefits investigation for patients that previously were using copay support I think you previously said that was about 20% of patients. Have you been able to make a dent in that number because the super commercial vials were flat quarter over quarter.

我想知道您是否可以談談您對先前使用共付額支持的患者進行福利調查的進展情況，我記得您之前說過大約有 20% 的患者。由於超級商業瓶裝飲料的銷售季度環比持平，您是否能夠減少這一數字？

Okay. Thank you so much for that question. Yes, I'll hand it over to David.

好的。非常感謝您提出這個問題。是的，我會把它交給大衛。

Yes. Great. Thank you for the question. I appreciate that. So we did report back in our earnings call for Q1 and about 20% of the market that shifted.

是的。偉大的。謝謝你的提問。我很感激。因此，我們在第一季的收益電話會議上報告了大約 20% 的市場變化。

And our patient assistance program, obviously, is being used at a higher rate. We are working through our cost assist program very closely with our offices, along with our reimbursement team inside the offices to make sure that when a patient hits an out-of-pocket max, they then get moved over to trade or commercial product as soon as they are able to do that. And there's a lot of communication between our teams and the offices and the reimbursement teams inside these accounts.

顯然，我們的患者援助計劃的使用率更高。我們正在與我們的辦公室以及辦公室內的報銷團隊密切合作，透過成本援助計劃來確保當患者達到自付費用最高限額時，他們能夠盡快轉移到貿易或商業產品。我們的團隊與這些帳戶內的辦公室和報銷團隊之間有很多溝通。

And yes, we can see definitely a trend where patients get transitioned over. But I can also tell you that the continued use of the program has been high because the funding issue is still in place. So as patients come out of their out-of-pocket max, we move them. The good thing is we're seeing quarter-over-quarter injection growth. and we have additional opportunities for patients to be on product, and it will transition them more as well.

是的，我們確實可以看到患者轉變的趨勢。但我也可以告訴大家，由於資金問題仍然存在，該計劃的持續使用率一直很高。因此，當患者自付費用超出最高限額時，我們就會轉移他們。好消息是，我們看到注射的銷量逐季成長。我們為患者提供了更多使用產品的機會，也將幫助他們實現更多的轉變。

I'm going to hand over to Tim as well just on some of the financial part of it.

我還將把部分財務方面的事情交給提姆。

Hey, Lachlan. I just want to caution against reading too much into any given quarter on the commercial valves delivered. That's actually from the specialty distributor to the ECP offices and there are inventory dynamics at the ECP offices that play into that. So that's why we kind of lead people to that injection growth as the true demand measure as opposed to looking at commercial vials. That's sort of in between two inventory stops. So I just wanted to caution on that on any given quarter.

嘿，拉克蘭。我只是想提醒大家，不要對任何季度交付的商用閥門進行過多的解讀。這實際上是從專業分銷商到 ECP 辦公室，並且 ECP 辦公室的庫存動態會影響這一點。因此，我們引導人們以注射成長作為真正的需求衡量標準，而不是專注於商業小瓶。這有點像是兩次庫存停止之間的情況。所以我只是想在任何特定季度對此提出警告。

Over time, that injection demand and the commercial vials delivered should more or less equate to each other. But on any given quarter, they're not going to be exact. So I wouldn't read too much into any particular quarter there.

隨著時間的推移，注射需求和交付的商業藥瓶應該或多或少地相等。但在任何一個季度，它們都不會完全準確。所以我不會對任何特定方面進行過多的解讀。

Annabel Samimy, Stifle.

安娜貝爾·薩米米（Annabel Samimy），《抑制》。

Just for SYFOVRE over again, you mentioned several times the market is about 10% -- I guess, 10% or 15% penetrated, depending on whose numbers you rely on. Do you have a sense now with the education of ophthalmologists and optometrists on what the total penetration could be of the market? I think it still has set a goal of about 35% of the target population by 2029. Does that being realistic based on what you're hearing back from the community?

再次提到 SYFOVRE，您多次提到市場滲透率約為 10%——我猜是 10% 或 15%，這取決於您依賴誰的數據。您是否了解現在對眼科醫師和驗光師的教育可以帶來什麼樣的市場總滲透率？我認為它仍然設定了2029年達到目標人口35%左右的目標。根據您從社區聽到的回饋，這現實嗎？

And I guess, separately on the funding gap, are there -- do you know of patients who are holding off starting treatment because of this funding gap? Or most of these patients who need treatment are getting free goods?

我想，另外，關於資金缺口，您是否知道有些患者因為資金缺口而推遲開始治療？還是這些需要治療的病人大部分得到的都是免費的物品？

Thank you, Samimy. So what I will say about kind of the growth beyond the -- a little more than 10% where we currently are, is if you take physicians that have adopted SYFOVRE as part of their routine practice, they end up treating between 30% and 50% of the GA population with SYFOVRE. So that is on a gross basis, that is probably the type that you should be looking at in terms of what population reading benefits from this product and also be looking forward to.

謝謝你，薩米。因此，我想說的是，如果醫生將 SYFOVRE 作為其日常實踐的一部分，那麼除了目前的 10% 多一點的增長之外，他們最終將用 SYFOVRE 治療 30% 到 50% 的 GA 患者。因此，從總體上看，這可能是您應該關注的類型，即哪些讀者可以從該產品中受益，並且值得期待。

As it relates to the funding gap, I will hand it over to Caroline for comments.

由於涉及資金缺口，我將把它交給 Caroline 徵求意見。

Thank you, Cedric. As someone who is still practicing ophthalmologists, we see this that patients are not able to start on treatment because of the funding gap what starting patient of SYFOVRE is not just a onetime thing, it's signing up for every four to eight weeks injections and having a long-term plan. So it's unfortunate that this is affecting patients who need this treatment or while some patients are able to compensate for that, others are not. So resolution, I think, will be very helpful for patients.

謝謝你，塞德里克。作為一名仍在從事眼科工作的醫生，我們看到，由於資金缺口，患者無法開始治療，SYFOVRE 的初始患者治療不是一次性的事情，而是每四到八週進行一次注射，並製定一個長期計劃。因此，不幸的是，這影響了需要這種治療的患者，或者雖然有些患者能夠彌補這一點，但其他患者卻不能。因此，我認為解決方案對於患者來說非常有幫助。

The other thing I want to say is that this is a really dynamic market and the retina practice in the United States is very dynamic. There are constantly new patients. There's constantly new retina physicians, new ophthalmologists, new types of eye care providers. And our process of doing medical education and education on GA is continuous. So physicians understand how to use this medication.

我想說的另一件事是，這是一個真正充滿活力的市場，美國的視網膜實踐也非常活躍。不斷有新病人來。不斷有新的視網膜醫生、新的眼科醫生、新類型的眼科護理提供者出現。我們進行醫學教育和 GA 教育的過程是連續的。因此醫生知道如何使用這種藥物。

And one of our key highlights at the ASRS meeting is showing a 48-month GALE data. And this really attests to the fact that there is increasing effects over time. And our key points here is that earlier treatment leads to more retina tissue [space]. And it's significant in the amount of the best treated group of up to over 3 millimeters squared of retina tissue that is about 1.5 disc areas of tissue. And just so you know, that's about the size of the (inaudible).

我們在 ASRS 會議上的一大亮點是展示 48 個月的 GALE 數據。這確實證明了隨著時間的推移，其影響會不斷增加。我們的重點是早期治療可以帶來更多的視網膜組織[空間]。治療效果最佳的一組視網膜組織面積可達 3 平方毫米以上，約為視網膜視盤面積的 1.5 倍，這點十分重要。你知道，這大約是（聽不清楚）。

So we show this image to our eyecare providers, and they're really impressed with how significant it is.

因此，我們將這張圖片展示給我們的眼部保健提供者，他們對它的重要性印象深刻。

Biren Amin, Piper Sandler.

比倫阿明、派珀桑德勒。

Maybe to start on SYFOVRE. Commercial doses, I think, in the quarter were 82,000 vials, but this number was a lot higher in Q4, which is around, I think, 89,000 commercial doses. So about a decline of about 9% from Q4. Is that due to conversion to free samples or are you seeing patient discontinuations from current patients with new patient starts predominantly going to free example? So that's the first question.

也許從 SYFOVRE 開始。我認為本季的商業劑量為 82,000 瓶，但第四季的這個數字要高得多，我認為約為 89,000 瓶。因此與第四季相比下降了約 9%。這是因為轉換為免費樣品還是因為您看到現有患者停止使用而新患者主要開始使用免費樣品？這是第一個問題。

And the second question, R&D expenses came in lighter. Should we expect the Q2 run rate going forward? Or should we assume the average over the last several quarters, which is around the low 80s.

第二個問題，研發費用減少。我們是否應該預期第二季的運行率會繼續上漲？或者我們應該假設過去幾個季度的平均值大約在 80 左右。

This is Tim. So in the fourth quarter, as you know, there was a bit of a build. And again, the vials delivered is dose from the specialty distributor to the ECP. And as we talked about in the fourth quarter, there was a lot of stocking at the ECP level. So the fourth quarter, unfortunately, is really not a good barometer for looking at growth or change over time.

這是蒂姆。因此，正如你所知，在第四季度，出現了一些增長。再次，從專業分銷商到 ECP 運送的小瓶劑量。正如我們在第四季度所討論的那樣，ECP 級別的庫存量很大。因此，不幸的是，第四季並不是衡量一段時間內成長或變化的良好晴雨表。

There are a lot of inventory dynamics between the (inaudible) distributor and the ECP fridges that we -- that tracks and again sort of to my prior comment, over time, that should average out to what the injection growth looks like. In any given quarter, it can be misleading as -- even in this quarter, right? It wasn't the growth versus the first quarter didn't exactly track injections. So we're hoping that will more normalize over time.

我們跟踪的（聽不清）分銷商和 ECP 冰箱之間存在很多庫存動態 - 並且再次按照我之前的評論進行跟踪，隨著時間的推移，這應該平均達到注入增長的樣子。在任何一個季度，它都可能產生誤導——即使在這個季度，對吧？與第一季相比，這並不是成長，也沒有準確追蹤注入。所以我們希望隨著時間的推移這種情況會變得更加正常。

So just a caution around that. It's -- commercial values delivered is something we talk about sort of as an industry. And we do that. But on any given quarter, I don't think it's the best measure. That's why we've talked about injections. So that's your first part.

所以對此要謹慎。我們所談論的是一個產業所傳遞的商業價值。我們確實這麼做了。但在任何一個季度，我認為這都不是最佳衡量標準。這就是我們討論注射的原因。這就是你的第一部分。

And then on your second part, in the Qs, we give a pretty good table on what's happening within the R&D expense. We do that on -- it's in the research and development expense section of our Q. And it breaks out those expenses pretty nicely. What you'll see is that we did have a pretty decent drop in a couple of areas for this quarter, but some of those were onetime options for some collaborative stuff we've done.

然後在第二部分，在問題中，我們給出了一個非常好的表格，顯示了研發費用的情況。我們在 Q 的研發費用部分這樣做。它很好地列出了這些費用。您會發現，本季度我們確實在幾個領域出現了相當大的下降，但其中一些是我們進行過的一些合作項目的一次性選擇。

However, I like -- at least for -- on a go-forward basis, I like the average a little bit better because we are heading into some pivotal studies that really haven't ramped up. That's the DGF study and the FSGS studies. So I think you're probably safer more in that average one than you are taking this quarter. But obviously, we had a few things that made this quarter look a little bit more efficient from an R&D perspective. But going forward, I would use the average.

然而，我喜歡——至少就未來而言，我更喜歡平均值，因為我們即將進行一些尚未真正加速的關鍵研究。這就是 DGF 研究和 FSGS 研究。因此，我認為，與本季相比，您在平均水平上可能更安全。但顯然，從研發角度來看，我們採取了一些措施，讓本季的效率更高一些。但展望未來，我會使用平均值。

Ryan Deschner, Raymond James.

瑞安‧德施納、雷蒙‧詹姆斯。

Thanks for the question. Just to clarify, when you report patient start forms and REMS enrollment for EMPAVELI in the future, will you be breaking these numbers out by specific indication i.e. PNH, C3G, and IC-MPGN? And can you also talk about what the burden will look like to obtain prior authorization for C3G and IC-MPGN patients?

謝謝你的提問。需要澄清的是，當您將來報告 EMPAVELI 的患者開始表格和 REMS 註冊情況時，您是否會根據特定適應症（例如 PNH、C3G 和 IC-MPGN）細分這些數字？您能否談談獲得 C3G 和 IC-MPGN 患者事先授權的負擔是什麼樣的？

Thanks for the question. So yes, on the metrics of the start forms that will come in initially when we report total start forms, over time, we'll start to look at how the data plays out and where we're penetrating by age group and disease state and difference in indications. But upfront, it will be start forms only, and then we'll transition over time to more data.

謝謝你的提問。所以是的，在我們報告總體開始表格時最初出現的開始表格指標上，隨著時間的推移，我們將開始研究數據如何發揮作用，以及我們在年齡組和疾病狀態以及適應症差異方面的滲透情況。但首先，它只是開始形式，然後我們會隨著時間的推移過渡到更多數據。

As per the burden of doing REMS form, I think that REMS certifications are done to inform physicians about these medications. So they're aware of the effect of them. I think that it's done with all-complement inhibitor therapy and physicians -- once, they don't have to do it again. And I think that it will not be a big burden on physicians to do that. Thank you.

根據 REMS 表格的負擔，我認為 REMS 認證是為了告知醫生有關這些藥物的資訊。所以他們知道它們的效果。我認為，只要採用全補體抑制劑療法，醫生就能夠完成這項治療——只要進行一次，就無需再進行第二次。我認為這樣做不會給醫生帶來太大的負擔。謝謝。

And then for the reenrollment patient start forms, will you be breaking down between C3G and IC-MPGN?

那麼對於重新入院患者開始表格，您會在 C3G 和 IC-MPGN 之間進行細分嗎？

Not initially, we won't. Everything will be just start forms and then we'll break it down as we learn more and we get more data.

一開始我們不會。一切都只是開始的形式，然後隨著我們了解更多和獲得更多數據，我們會將其分解。

Douglas Tsao, H.C. Wainwright.

Douglas Tsao、H.C. Wainwright。

I'm just curious, are you seeing relatively consistent utilization of free goods across all retina specialists or is there sort of some practices that are using it more than others based on patient mix? And so I guess, as this funding shortage exists, is there a way for you to sort of target the market a little bit more towards patients who might be able to sort of afford the out-of-pocket for the time being?

我只是好奇，您是否看到所有視網膜專家都相對一致地使用免費物品，或者根據患者構成，是否有一些診所比其他診所更多地使用免費物品？因此我想，由於存在資金短缺，您是否有辦法將市場更多地瞄準那些暫時能夠負擔自付費用的患者？

Yeah. Great question. Thank you. This is David. So let me answer the first part of it. So when you look at the marketplace, what I think is a really good metric to look at is the true demand, which is the growth quarter over quarter in injection. So we should start there. And I think the part to also keep in mind is that when a physician wants to put a patient on a product, they can use free good to do that, and they're putting those patients on product through our health assist program, and we can transition them over when their out-of-pocket max is met. So I think it's important to keep that in mind.

是的。好問題。謝謝。這是大衛。那麼就讓我來回答第一部分。因此，當你觀察市場時，我認為一個真正好的指標是真實需求，即註射量逐季度的成長。所以我們應該從那裡開始。我認為還需要記住的是，當醫生想要讓患者使用某種產品時，他們可以使用免費產品來做到這一點，他們透過我們的健康援助計劃讓這些患者使用產品，當達到他們的自付費用最高限額時，我們可以讓他們轉換。所以我認為牢記這一點很重要。

As far as the targeting part of it and how we try to make sure that we're in the right places with the right benefit design discussions, we have a reimbursement team. I also have a health assist organization that connects with these offices on regular basis. We've had a very concerted effort in these offices to go in and educate on benefit design. So that those accounts can help patients pick the right benefit in Medicare that will pay for thse products, even today and the funding issues that we have over time, right? So we've been close to the education on it, so we've done a lot of targeting, and I think that's helped a lot of the feedback we've gotten back from the offices, and we'll continue to do that. And overtime these patients will then transition either to a new benefit design or they'll transition because of out-of-pocket max to (inaudible).

至於目標部分以及我們如何確保在正確的地方進行正確的福利設計討論，我們有一個報銷團隊。我還有一個健康援助組織定期與這些辦公室聯繫。我們在這些辦公室做出了非常一致的努力，深入進行福利設計的教育。這樣，這些帳戶就可以幫助病患選擇合適的醫療保險福利來支付這些產品的費用，即使在今天，我們也會遇到資金問題，對嗎？因此，我們一直密切關注這方面的教育，因此我們做了很多針對性的工作，我認為這對我們從辦公室得到的回饋有很大幫助，我們將繼續這樣做。隨著時間的推移，這些患者要么會轉向新的福利設計，要么會因為自付費用上限而轉向（聽不清楚）。

And if I can -- if I may, one follow up. Just curious when you think about the patients that are getting treated today, I think, in the past, you'd refer to sort of like most -- like sort of just almost all of them were coming from existing retina specialist books or existing patient-based populations. Are you seeing more patients come from referrals directly and are you seeing a shift in terms of the time from of the patient's initial diagnosis of GA to start a treatment?

如果可以的話，我也會跟進。我只是好奇，當您想到今天接受治療的患者時，我想，在過去，您會提到大多數——幾乎所有患者都來自現有的視網膜專家書籍或現有的患者群體。您是否看到更多的患者直接來自轉診，並且您是否看到患者從最初診斷 GA 到開始治療的時間發生了變化？

Yeah, so we have a program. We've got actually a couple of programs where we've got folks that are in these offices for ophthalmology and optometry, specifically for education and specifically so, patients cannot be identified and then referred to a treating retina specialist, and that has, obviously, been running for quite some time now, but, and we do see data in transition.

是的，我們有一個計劃。實際上，我們已經有幾個項目，在這些辦公室安排了一些眼科和驗光人員，專門用於教育，具體來說，患者無法被識別，然後被轉診給治療視網膜的專家，顯然，這些項目已經運行了相當長一段時間，但是，我們確實看到數據正在轉變。

I will tell you one thing to keep in mind and as we move those patients over, there are still a lot of patients inside these offices, whether treating injecting offices and retina specialists are that could go on treatment because about 50% of the market sits in those offices already. And then the market is very large, as you know. So there's opportunities on both sides.

我要告訴你一件事，要記住，當我們把這些病人轉移過來時，這些辦公室裡仍然有很多病人，無論是治療注射辦公室還是視網膜專家都可以繼續接受治療，因為大約 50% 的市場已經在這些辦公室裡了。如你所知，市場非常大。因此雙方都有機會。

Yes, we can see that (inaudible), and we do know the feral processes and our TPC alongside of that is working.

是的，我們可以看到（聽不清楚），我們確實知道野生過程以及我們的 TPC 正在發揮作用。

Derek Archila, Wells Fargo.

富國銀行的德里克‧阿奇拉 (Derek Archila)。

This is Simone on for Derek. Congrats on the quarter. Just one question. Can you guys provide more color on the free drug trends? And how should we be thinking about the percent for the rest of the year? And is the 10% to 15% range still valid that you said last quarter?

這是西蒙娜 (Simone) 代替德里克 (Derek)。恭喜本季取得佳績。只有一個問題。你們能否提供更多有關免費藥物趨勢的資訊？那我們該如何考慮今年剩餘時間的百分比呢？您上個季度所說的 10% 到 15% 的範圍仍然有效嗎？

Yeah. So let me answer that on the free drug part of it. And like I mentioned a few minutes ago, we expect similar levels of drug that's going to be used moving forward. We did have a $13 million headwind in the second quarter as a result of free goods being used. But what I'm mostly encouraged by and the demand at the physician and the patient model continues to grow, and that's why we see injection growth that we're seeing today.

是的。那麼讓我來回答一下有關免費藥物的部分。正如我幾分鐘前提到的，我們預計未來藥物的使用量將保持類似水平。由於使用免費商品，我們在第二季確實遭遇了 1,300 萬美元的虧損。但最讓我感到鼓舞的是，醫生和患者模式的需求持續成長，這就是我們今天看到注射成長的原因。

Judah Frommer, Morgan Stanley.

猶大‧弗洛默，摩根士丹利。

First, just kind of on more of a high-level market penetration question. Do you see achieving kind of the market penetration in GA that you've discussed over time along with SYFOVRE and maybe additional patient and provider education? Or do you think you might need a next-gen product like the 3007 combination to get there?

首先，這只是一個更高層次的市場滲透問題。您是否認為可以實現您在一段時間內討論過的 GA 市場滲透，以及 SYFOVRE 和額外的患者和提供者教育？或者您認為您可能需要像 3007 組合這樣的下一代產品才能實現這一目標？

And then secondarily, just a housekeeping question, on the Sobi royalty. Can you walk us through how that's going to be recorded in the financials, whether it's going to run through the income statement or the balance sheet or both?

其次，我問一個關於 Sobi 皇室的常規問題。您能否向我們介紹如何在財務報表中記錄這些費用，是記入損益表還是資產負債表，還是兩者兼具？

Yeah, thank you so much for these questions. So first of all, as it relates to the penetration, I want to reiterate that we are now in a -- we have a stable business with SYFOVRE with steady and gradual growth in front of us. And again, I think remarkable data over the course of a full four-year follow-up in these patients that allow us to really to expand on what the efficacy profile means for this drug and what it means for patients to be on treatment.

是的，非常感謝您提出這些問題。因此，首先，就滲透率而言，我想重申，我們現在與 SYFOVRE 有著穩定的業務往來，並且未來將實現穩步、漸進的成長。而且，我認為對這些患者進行整整四年的追蹤調查所獲得的重要數據使我們能夠真正擴展這種藥物的療效特徵以及它對接受治療的患者的意義。

We do have, as you may know, a next-generation products in development. But this is a next-generation product that will actually combine with SYFOVRE with an easy-to-administer subcutaneous injection which is an siRNA product.

如您所知，我們確實正在開發下一代產品。但這是一種下一代產品，它實際上將與 SYFOVRE 結合，採用易於管理的皮下注射，這是一種 siRNA 產品。

So what we're going to be testing in that clinical trial is whether we can give SYFOVRE three months in every two months and whether the reduction of the lesion growth, which is 30% to 40%, with SYFOVRE whether we can expand that and go hopefully well beyond 50% in terms of vision size reduction.

因此，我們將在臨床試驗中測試我們是否可以每兩個月進行三個月的 SYFOVRE 治療，以及病灶生長減少量（30% 至 40%）是否可以透過 SYFOVRE 擴大，並希望在視力縮小方面遠超過 50%。

This would make it more convenient for patients, expand on the already impressive efficacy that SYFOVRE has. And by the way, I want to point out here as well that in the four-year data set, we now have very clear indicators of the functional benefit that patients gain from SYFOVRE. With the subcutaneous product, it's easy to administer, would be off-injector and will make it every three months instead of their two months. Importantly, I think we are the leaders in geographic atrophy. And targeting C3 is definitely very clear now the way to address disease in the first place.

這將為患者帶來更多便利，並進一步擴大 SYFOVRE 已經令人印象深刻的療效。順便說一句，我也想在這裡指出，在四年的資料集中，我們現在有非常明確的指標來表明患者從 SYFOVRE 中獲得的功能益處。使用皮下產品，使用起來很方便，無需注射器，而且每三個月注射一次，而不是每兩個月注射一次。重要的是，我認為我們是地理萎縮的領導者。現在，針對 C3 進行治療無疑是治療疾病的首要方法。

Yeah, Judah, and I'll just jump in on your housekeeping question. So it's a very simple recognition. So the payment upfront will be recognized as revenue, and it will show up on the balance sheet in cash.

是的，猶大，我只是想回答你的家務問題。所以這是一個非常簡單的識別。因此，預付款將被確認為收入，並以現金形式顯示在資產負債表上。

Greg Harrison, Scotiabank.

加拿大豐業銀行的格雷格·哈里森。

This is Joe on for Greg. Just a quick one on C3G and IC-MPGN. How are you seeing the competitive landscape evolving there, considering the competitors working on studies to kind of expand their patient population going forward? So kind of over the longer time horizon, how do you think that could play out with EMPAVELI?

這是喬，代替格雷格。簡單介紹一下 C3G 和 IC-MPGN。考慮到競爭對手正在進行研究以擴大其未來患者群體，您如何看待那裡的競爭格局演變？那麼從較長的時間範圍來看，您認為 EMPAVELI 將會扮演怎樣的角色？

Yes. Thank you for that question. So first of all, again, I want to highlight that what we did in the VALIANT study was go very broad, right? We studied C3G and IC-MPGN. IC-MPGN is a separate trial for our competitor, which will take a while to read out.

是的。謝謝你的提問。所以首先，我想再次強調，我們在 VALIANT 研究中所做的工作非常廣泛，對嗎？我們研究了C3G和IC-MPGN。IC-MPGN 是我們競爭對手的單獨試驗，需要一段時間才能讀取。

We also included the pediatric population. There is a separate trial for pediatrics by a competitor, which will take time to read out. And we studied pre and post transplant as well.

我們還包括兒科族群。競爭對手針對兒科進行了單獨的試驗，需要時間來解讀。我們也研究了移植前和移植後的情況。

What is remarkable about VALIANT It's not just the fact that we had to trifactor efficacy with kind of these profound beneficiary effects that we saw across proteinuria GFR as well as the deposition of C3 in the kidney, but also how homogenous that readout was across both populations. And that is why we got the label that we did.

VALIANT 的非凡之處不僅在於我們必須將三因素功效與我們在蛋白尿 GFR 以及腎臟中 C3 沉積中看到的這些顯著受益效應結合起來，還在於兩個人群的讀數是多麼的同質。這就是我們獲得這個標籤的原因。

So I think moving forward, again, this is a product that can be life-changing for patients, and we look forward to providing it as soon as possible for as many patient vessels.

因此，我認為，展望未來，這是一種可以改變患者生活的產品，我們期待盡快為盡可能多的患者提供該產品。

Greg Suvannavejh, Mizuho.

瑞穗的 Greg Suvannavejh。

I wanted to revist a question that was asked earlier with respect to growth for the category, this is SYFOVRE in GA. Relative to your comments about seeing a very stable business now, where growth will be steady and that's great to see, I'm wondering if you can again just revisit your thoughts around how your competitor is seeing or has projected that their product can potentially grow in the upper 20s on a quarterly basis? And if you have any insights as to whether that is a reflection of market growth and perhaps your view of low to mid-single-digit growth is perhaps conservative?

我想重新回顧一下先前提出的有關該類別成長的問題，這是喬治亞州的 SYFOVRE。相對於您所說的現在看到非常穩定的業務、增長將會穩步並且很高興看到這一點的評論，我想知道您是否可以再次重新審視您對競爭對手的看法，或者預測他們的產品每季度可能會增長 20% 以上？您是否知道這是否反映了市場成長，並且您對低至中位數個位數成長的看法是否有些保守？

Yes. So again, I want to point out, first of all, our clear leadership in this category across every metric, right? Revenue new patient share, overall market share, trials injections, preferred payer coverage and then also the presence at academic conferences. We have these long-term data, and we have a very thorough understanding of the market dynamics.

是的。因此，我想再次指出，首先，我們在這一類別的各個指標上都處於明顯的領先地位，對嗎？收入新患者份額、整體市場份額、試驗注射、優先付款人覆蓋範圍以及學術會議的出席情況。我們擁有這些長期數據，並且對市場動態有非常透徹的了解。

So we don't want to comment on what, of course, our competitor, I believe the market looks like. But I think the key thing here is that with the right data set enhanced, which is a full four years of data in our hands, consistently showing increasing benefits over time, the benefits of every other month dosing, where our competitor is still talking about the one-year data, which is many years old; I think we have the better rest on what can happen within this space.

因此，我們不想評論我們的競爭對手，我相信市場是什麼樣的。但我認為這裡的關鍵在於，透過增強正確的數據集，也就是我們手中整整四年的數據，持續顯示出隨著時間的推移收益不斷增加，每隔一個月劑量的好處，而我們的競爭對手仍在談論一年的數據，這已經是很多年前的事了；我認為我們可以更好地了解這個領域會發生什麼。

Lisa Walter, RBC.

麗莎·沃爾特（RBC）。

Maybe just one on EMPAVELI. On the call on Tuesday, you reiterated that EMPAVELI has potential for blockbuster status. So I was just wondering, could you walk us through the path to get there? Does that also include further label expansion into other kidney indications or even beyond that? Any color here would be helpful.

也許 EMPAVELI 上只有一個。在周二的電話會議上，您重申了 EMPAVELI 具有成為轟動一時的公司潛力。所以我只是想知道，您能帶我們走這條路去那裡嗎？這是否還包括進一步擴展到其他腎臟適應症甚至更遠的適應症？這裡的任何顏色都會有幫助。

Yes. I think -- look, I mean, we shared with you the numbers on the demographics, right? So we estimate conservatively that our 5,000 patients between C3G and IC-MPGN, that approximately half of these patients have IC-MPGN that approximately 20% of these patients are transplanted at probably about 15% to 20% of these patients fall in the pediatric category, which means that we would only be competing with the only other available products where we are differentiated again, as we've outlined many times now, for 1,500 to maybe 2,000 out of those 5,000 patients.

是的。我認為——你看，我的意思是，我們與你們分享了人口統計數據，對嗎？因此，我們保守估計，在 C3G 和 IC-MPGN 之間的 5,000 名患者中，大約有一半患者患有 IC-MPGN，大約有 20% 的患者接受了移植，大約有 15% 到 20% 的患者屬於兒科類別，這意味著我們只會與其他可用產品競爭，正如我們多次概述的那樣，我們在這 2000 到名患者再次與眾不同。

In terms of revenue, every 1,000 patients could represent approximately $0.5 billion in revenue. So that is what this particular approval means for us in terms of potential revenue moving forward. The additional potential approvals in FSGS and DGS, obviously will take some time to run the clinical trials and to find out if the drug works and how well it works in these indications, we would then be in a decision to what we can do there. And of course, in the backlog, there's always the P&H business, which continues as well.

從收入來看，每1,000名患者可帶來約5億美元的收入。這就是這項特別批准對我們未來潛在收入的意義。FSGS 和 DGS 的額外潛在批准顯然需要一些時間進行臨床試驗，以確定該藥物是否有效以及在這些適應症中的效果如何，然後我們才能決定我們可以做些什麼。當然，在積壓訂單中，一直有 P&H 業務，該業務也在繼續。

Thank you. I'm showing no further questions at this time. I would now like to turn the call back over to Mr. Cedric Francois for any closing remarks.

謝謝。我目前沒有其他問題。現在我想將電話轉回給塞德里克·弗朗索瓦先生，請他做最後發言。

Thank you so much, and thank you, everyone, for your thoughtful questions. This concludes the Apellis second quarter earnings call, second one of the week. And we hope you have a wonderful rest of the day. If you have questions, don't hesitate to reach out to our team, and we'll be happy to answer what we can. Thank you.

非常感謝，也感謝大家提出的深思熟慮的問題。這就是 Apellis 第二季財報電話會議的結束，這是本週第二次電話會議。我們希望您今天剩下的時間過得愉快。如果您有任何疑問，請隨時聯絡我們的團隊，我們將竭誠為您解答。謝謝。

This concludes today's program. Thank you all for participating. You may now disconnect.

今天的節目到此結束。感謝大家的參與。您現在可以斷開連線。