Apellis Pharmaceuticals Inc (APLS) 2025 Q1 法說會逐字稿

Hello, everyone, and welcome to the Q1 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 2025 年第一季 Apellis Pharmaceuticals, Inc. 收益電話會議。（操作員指示）請注意，今天的會議正在錄音。

Now, it's my pleasure to turn the call over to the Vice President of Communications, Tracy Vineis. The floor is yours.

現在，我很高興將電話轉給通訊副總裁 Tracy Vineis。現在輪到你了。

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

早安，感謝您加入我們討論 Apellis 2025 年第一季的財務表現。與我一起參加電話會議的還有聯合創始人兼首席執行官 Cedric Francois 博士、首席財務官 Tim Sullivan、商業執行副總裁 David Acheson 和首席醫療官 Caroline Baumal 博士，她正在電話中回答問答。

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, and thank you all for joining us this morning. As many of you know, Apellis is a commercial-stage biopharmaceutical company with two approved C3 targeting therapies, SYFOVRE and EMPAVELI and a growing pipeline of novel therapeutic compounds. Our focus is on addressing diseases with significant unmet need through targeted inhibition of the complement system.

謝謝你，特蕾西，也謝謝大家今天早上加入我們。眾所周知，Apellis 是一家商業階段的生物製藥公司，擁有兩種已批准的 C3 標靶療法 SYFOVRE 和 EMPAVELI，以及不斷增長的新型治療化合物產品線。我們的重點是透過針對性抑制補體系統來解決存在嚴重未滿足需求的疾病。

The first quarter of 2025 presented a combination of challenges and progress. Despite growth in injection demand, we faced a unique set of market dynamics that impacted SYFOVRE revenue performance. Meanwhile, we advanced EMPAVELI closer to its second approval with the FDA granting priority review designation for C3G and IC-MPGN and PDUFA date that is now less than 3 months away. Let's begin with SYFOVRE. While first quarter SYFOVRE injection demand grew 4% quarter-over-quarter, revenue came in below expectations.

2025年第一季既有挑戰，也有進步。儘管注射需求有所增長，但我們仍面臨一系列影響 SYFOVRE 收入表現的獨特市場動態。同時，隨著 FDA 授予 EMPAVELI C3G 和 IC-MPGN 優先審查資格以及 PDUFA 日期，我們已將 EMPAVELI 推進至第二次批准的階段，現在距離批准僅剩不到 3 個月的時間。讓我們從 SYFOVRE 開始。儘管第一季 SYFOVRE 注射需求較上季成長 4%，但營收低於預期。

We believe that this shortfall was primarily driven by two factors. As mentioned already in our Q4 earnings call, they were funding shortages at third-party co-pay assistance programs. There was also a larger-than-expected drawdown of total channel inventory during the first quarter, including in physician offices. Tim and David will share more details on these dynamics shortly.

我們認為，造成這種缺口主要是由兩個因素造成的。正如我們在第四季財報電話會議上所提到的，第三方共同支付援助計畫的資金短缺。第一季度，包括醫生辦公室在內的總通路庫存下降幅度也超出預期。蒂姆和大衛將很快分享有關這些動態的更多細節。

Competitively, we continue to strengthen our market leadership within geographic atrophy. Satori maintains more than 60% of the overall market and new patient starts continue to grow exceeding 50% during the first quarter and already reaching 55% by late April. GA represents a significant unmet need and GA therapies are only in the early stages of adoption. We expect continued but modest market growth in the near term, and are confident that our efforts in the field will translate into meaningful growth for SYFOVRE over time.

在競爭方面，我們持續加強地域萎縮範圍內的市場領導地位。Satori 佔了超過 60% 的整體市場份額，第一季新病患數量持續成長超過 50%，到 4 月底已經達到 55%。GA 代表著一個尚未滿足的重大需求，而 GA 療法才剛剛處於採用的早期階段。我們預計短期內市場將持續但溫和地成長，並相信我們在該領域的努力將隨著時間的推移轉化為 SYFOVRE 的有意義的成長。

Shifting now to EMPAVELI where we are gearing up for a major launch of our second potential blockbuster opportunity. We have made significant strides towards our goal of bringing EMPAVELI to more patients in the first quarter. Supplemental NDA for C3G and IC-MPGN was accepted by the FDA and granted priority review designation with a PDUFA date of July 28. The Phase III VALIANT results demonstrated EMPAVELI's potential for disease modification across all patient subgroups, achieving the trifecta of glomerular disease endpoints.

現在我們轉向 EMPAVELI，準備大力推出我們的第二個潛在重磅機會。我們已朝著在第一季度為更多患者提供 EMPAVELI 的目標邁出了重大一步。C3G 和 IC-MPGN 的補充 NDA 已被 FDA 接受，並被授予優先審查資格，PDUFA 日期為 7 月 28 日。III 期 VALIANT 研究結果證明了 EMPAVELI 在所有患者亞群中改善疾病的潛力，實現了腎小球疾病終點的三重奏。

First, an unprecedented 68% reduction in proteinuria. second, stabilization of kidney function as measured by eGFR and finally, substantial clearing of C3C staining. We look forward to presenting the VALIANT 52-week data at the European Renal Association Congress in early June.

首先，蛋白尿史無前例地減少了 68%。其次，透過 eGFR 測量，腎功能穩定，最後，C3C 染色基本上清除。我們期待在 6 月初的歐洲腎臟協會大會上展示 VALIANT 52 週數據。

U.S. approval and launch of EMPAVELI in C3G and IC-MPGN will represent Apellis' third new product launch in just 4 years. We are carrying this momentum forward. and looking to build on the success of EMPAVELI in rare nephrology indications. We remain on track to initiate pivotal studies in focal segmental glomerulosclerosis and delayed graft function in the second half of this year.

EMPAVELI 在 C3G 和 IC-MPGN 中的核准和上市將是 Apellis 在短短 4 年內推出的第三款新產品。我們正在延續這一勢頭，並期待在 EMPAVELI 治療罕見腎臟病適應症方面取得更大成功。我們仍將在今年下半年啟動局部節段性腎小球硬化和移植功能延遲的關鍵研究。

I will now turn the call over to Tim to provide a review of the financials from the first quarter. Tim?

現在我將把電話轉給提姆，讓他回顧第一季的財務狀況。提姆？

Thank you, Cedric. We are very encouraged by the growth in SYFOVRE injection demand during the first quarter. Injections are the true measure of demand, and this performance gives us confidence that the market for SYFOVRE is growing. However, SYFOVRE net product revenue was $130 million for the first quarter which was down due to two primary factors.

謝謝你，塞德里克。我們對第一季 SYFOVRE 注射需求的成長感到非常鼓舞。注射是衡量需求的真正指標，這種表現讓我們相信 SYFOVRE 市場正在成長。然而，SYFOVRE 第一季淨產品收入為 1.3 億美元，下降主要歸因於兩個因素。

First, there was a unique inventory dynamic impacting the first quarter, as you can see on Slide 6. During Q4, physician demand drove a larger-than-expected build of inventory in physician offices, which led to a corresponding inventory increase at the distributor. We believe this increased physician demand was driven by stronger preference for SYFOVRE and regulatory concerns for the competitor product. In Q1, we saw a drawdown of inventory at both the distributor and physician offices and total channel inventory returned to more typical levels by the end of the quarter. Most of the quarter-over-quarter revenue decline was related to this Q1 channel inventory drawdown.

首先，正如您在投影片 6 中看到的那樣，第一季受到了獨特的庫存動態影響。在第四季度，醫生的需求推動醫生辦公室的庫存增加超出預期，導致分銷商的庫存相應增加。我們認為，醫生需求的增加是由於對 SYFOVRE 的偏好增強以及對競爭產品的監管擔憂所致。在第一季度，我們看到分銷商和醫生辦公室的庫存都有所減少，到本季度末，總通路庫存恢復到了更典型的水平。大部分季度環比收入下降與第一季通路庫存減少有關。

The second impact to SYFOVRE revenue was a funding shortage of third-party co-pay assistance organizations that resulted in increased physician and patient reliance on samples. As we discussed in our fourth quarter call, in connection with the funding shortage, nonrevenue-generating sample doses delivered were more than twice the average seen in previous quarters. We expect a similar amount of sample to be used going forward. We estimate that this shift to sample use impacted Q1 revenue by approximately $10 million. To put it simply, adjusting Q4 and Q1 for this inventory dynamic, revenue would have been consistent quarter-over-quarter.

對 SYFOVRE 收入的第二個影響是第三方共同支付援助組織的資金短缺，導致醫生和病人對樣本的依賴增加。正如我們在第四季度電話會議上所討論的那樣，由於資金短缺，交付的非創收樣品劑量是前幾季平均值的兩倍多。我們預計未來將使用類似數量的樣本。我們估計，這種轉向使用樣本對第一季的收入影響了約 1000 萬美元。簡而言之，根據庫存動態調整第四季和第一季度，營收將與上一季保持一致。

Without the co-pay assistance funding shortage, we would have expected growth to have been more in line with injection growth.

如果沒有共同支付援助資金短缺，我們預計成長將與注入成長更加一致。

We've spoken about demand, and now let's turn to price dynamics. We continue to diligently manage our ASP or average sales price and expect the SYFOVRE gross to net percentage to be in the low to mid-20s through 2025.

我們已經討論了需求，現在讓我們來討論價格動態。我們將繼續努力管理我們的 ASP 或平均銷售價格，並預計到 2025 年 SYFOVRE 毛利與淨利的百分比將保持在 20% 左右。

Turning now to operating expenses. We executed significant cost savings in late 2023 and have since maintained that financial discipline into 2025 completing the necessary reduction in our EU commercial infrastructure while also efficiently scaling for a successful launch in C3G and IC-MPGN. We continue to expect that our 2025 operating expenses will remain in line with our 2024 operating expenses. Also, we are closely monitoring the tariff situation and will take steps to mitigate any adverse impact it could have on our business. With $358 million in cash and cash equivalents at the end of the first quarter, we remain confident that our existing cash, combined with future product sales and ex U.S.

現在來談談營運費用。我們在 2023 年底實現了大幅成本節約，並在 2025 年保持這種財務紀律，完成了歐盟商業基礎設施的必要削減，同時還有效擴展以成功在 C3G 和 IC-MPGN 中推出。我們仍預期 2025 年的營運費用將與 2024 年的營運費用保持一致。此外，我們正在密切關注關稅情況，並將採取措施減輕其對我們業務可能造成的不利影響。截至第一季末，我們擁有 3.58 億美元的現金和現金等價物，我們仍然相信，我們現有的現金加上未來的產品銷售額和美國以外的收入，將足以支撐我們未來的業務。

royalties will be sufficient to fund our business to profitability.

特許權使用費將足以支持我們的業務獲利。

I will now hand the call over to David for a commercial update. David?

我現在將把電話交給大衛，讓他講一講商業更新情況。戴維？

Thank you, Tim, and good morning, everyone. In the first quarter, there were approximately 92,000 SYFOVRE doses delivered to physician offices, including 82,000 commercial doses and 10,000 samples. As Tim and Cedric noted, there is a funding shortage at the co-pay assistant programs that has impacted demand for commercial doses resulting in increased sample usage. Despite this headwind, we successfully drove growth in total injection demand in the first quarter. SYFOVRE remained the clear market leader with overall market share exceeding 60% and share of new patient starts above 50%.

謝謝你，提姆，大家早安。第一季度，約有 92,000 劑 SYFOVRE 疫苗交付給醫生辦公室，其中包括 82,000 劑商業劑量和 10,000 個樣本。正如蒂姆和塞德里克所指出的，共同支付助理項目資金短缺，影響了商業劑量的需求，導致樣本使用量增加。儘管面臨這種不利因素，我們仍然成功地推動了第一季總注入需求的成長。SYFOVRE 仍然是明顯的市場領導者，整體市佔率超過 60%，新患者份額超過 50%。

Injection demand continued to grow with the share of new patient starts already reaching 55% by late April. There remains tremendous opportunity in the GA market. We put several initiatives in place to continue to drive demand and new patient starts, including leveraging our DTC campaign where we have seen a meaningful increase in traffic to syfovre.com relative to the monthly average in 2024.

注射需求持續成長，截至 4 月底，新患者的注射比例已達 55%。通用航空市場仍存在巨大的機會。我們採取了多項措施來繼續推動需求和新患者的開始，包括利用我們的 DTC 活動，我們發現 syfovre.com 的流量相對於 2024 年的月平均流量有顯著增長。

Once patients reach our website, they can use our Find a Doctor tool to identify retina specialists that are experienced in treating GA. We are highlighting SYFOVRE's unique 48-month GALE extension study results that demonstrated SYFOVRE's ability to preserve meaningfully more retina tissue when physicians treat patients early and keep them on treatment over time. We've built a robust field team that is focused on growing the market through educating optometrists and ophthalmologists on the importance of treating GA and SYFOVRE's differentiated product profile.

一旦患者造訪我們的網站，他們就可以使用我們的「尋找醫生」工具來找到有治療 GA 經驗的視網膜專家。我們重點介紹 SYFOVRE 獨特的 48 個月 GALE 擴展研究結果，該結果證明了當醫生早期治療患者並長期讓他們接受治療時，SYFOVRE 能夠保留更多的視網膜組織。我們建立了一支強大的現場團隊，致力於透過教育驗光師和眼科醫生了解治療 GA 和 SYFOVRE 差異化產品的重要性來擴大市場。

We also provide resources so that the GA patients can seek treatment with a retina specialist. To mitigate issues with the co-pay assistance programs, we are launching education programs on best practices for managing patient reimbursement. We're working to educate practices about patient benefit designs potential impacts to out-of-pocket expenses and how our Apellis Assist program can offer education to retina offices.

我們也提供資源，以便 GA 患者可以向視網膜專家尋求治療。為了緩解共同支付援助計劃的問題，我們正在啟動有關管理患者報銷的最佳實踐的教育計劃。我們正在努力教育實踐有關患者福利設計對自付費用的潛在影響以及我們的 Apellis Assist 計劃如何為視網膜辦公室提供教育。

SYFOVRE's gains in new patient starts reflect that its differentiated profile is resonating driven by its robust efficacy, flexible dosing and preferred position with many payers.

SYFOVRE 在新患者數量上的成長反映出，其差異化產品引起了共鳴，這得益於其強大的療效、靈活的劑量以及眾多付款人的優先地位。

Turning now to the anticipated launch of EMPAVELI in C3G and IC-MPGN. The commercial and medical teams are ramping up their efforts in anticipation of EMPAVELI's potential label expansion later this year. We are executing several prelaunch activities and working to drive disease state awareness. Our approach to maximizing the potential for EMPAVELI in these diseases is 3-pronged.

現在談談預計在 C3G 和 IC-MPGN 推出的 EMPAVELI。商業和醫療團隊正在加緊努力，以應對 EMPAVELI 今年稍後可能出現的標籤擴張。我們正在執行幾項發布前活動並致力於提高人們對疾病狀態的認識。我們採取三管齊下的方法來最大限度地發揮 EMPAVELI 在這些疾病中的潛力。

First, highlight the urgency for a treatment that addresses underlying disease pathology. Second, ensure seamless access to treatment for patients upon approval; and third, establish EMPAVELI as the market leader in C3G and IC-MPGN. Our field teams are already in place and building relationships with key physician accounts. We're working with payers to ensure coverage and access to EMPAVELI upon approval. We're also engaging with physicians and KOLs at medical conferences.

首先，強調針對潛在疾病病理的治療的迫切性。第二，確保患者在獲得批准後能夠無縫獲得治療；第三，使 EMPAVELI 成為 C3G 和 IC-MPGN 市場的領導者。我們的現場團隊已經到位並與主要醫生建立關係。我們正在與付款人合作，以確保在獲得批准後能夠獲得 EMPAVELI 的覆蓋和使用。我們也在醫學會議上與醫生和關鍵意見領袖進行交流。

The U.S. commercial opportunity is significant with an estimated 5,000 C3G and IC-MPGN patients. Given the strength of the VALIANT data, we believe EMPAVELI will be used across all patient groups and disease severities. As many C3G and IC-MPGN patients will progress to end-stage renal disease, physician feedback has been consistent that treatment choice will be primarily based on efficacy, not route of administration.

美國的商業機會巨大，預計有 5,000 名 C3G 和 IC-MPGN 患者。鑑於 VALIANT 數據的強大，我們相信 EMPAVELI 將適用於所有患者群體和疾病嚴重程度。由於許多 C3G 和 IC-MPGN 患者會發展為末期腎病，醫師的回饋一致認為，治療選擇主要基於療效，而不是給藥途徑。

As Cedric mentioned, full 52-week data from the VALIANT study will be presented at the ERA conference in June. We expect this to drive further excitement for EMPAVELI within the treatment community.

正如 Cedric 所提到的，VALIANT 研究的完整 52 週數據將於 6 月的 ERA 會議上公佈。我們希望這將進一步激發治療界對 EMPAVELI 的興趣。

Switching now to PNH. Net product revenue for EMPAVELI in the first quarter was $20 million. Compliant rates remain high at 97%, and the safety profile remains consistent with our previous updates.

現在切換到 PNH。EMPAVELI 第一季的淨產品收入為 2,000 萬美元。合規率仍然高達 97%，安全狀況與我們先前的更新保持一致。

With that, I will now turn the call over to Cedric for closing remarks.

現在，我將把電話交給塞德里克 (Cedric) 做結束語。

Thank you, David. As we discussed, there is a lot to look forward to. The remainder of 2025 will be a pivotal year for execution. I am confident in our team's ability to capitalize on the strong physician demand for SYFOVRE, and I am excited about the potential for EMPAVELI to transform the treatment C3G and IC-MPGN.

謝謝你，大衛。正如我們所討論的，有很多事情值得期待。2025 年剩餘時間將是執行的關鍵一年。我相信我們的團隊有能力利用醫生對 SYFOVRE 的強烈需求，我對 EMPAVELI 改變 C3G 和 IC-MPGN 治療的潛力感到興奮。

We continue to make progress towards becoming a profitable, well-established biotechnology company with a promising pipeline and approved products across retinal nephrology and hematological diseases. Our objective is clear: successfully execute our strategy, drive revenue growth, maintain financial discipline and most importantly, continue to deliver meaningful treatments to patients in need.

我們將繼續努力，成為一家盈利良好、成熟的生物技術公司，擁有覆蓋視網膜腎病變和血液疾病領域的有前景的產品線和核准產品。我們的目標很明確：成功執行我們的策略，推動收入成長，保持財務紀律，最重要的是，繼續為有需要的患者提供有意義的治療。

Before I open it up for Q&A, I would like to take a moment to welcome the newest member to our Board of Directors, (inaudible) Greg is the former CEO of Momenta and Founder and CEO of Headwaters Biotech Advisers. He has more than 30 years of leadership experience across the biopharmaceutical industry and has successfully grown companies into strong commercial organizations with robust pipelines. His expertise will be a tremendous asset, and we are thrilled to have him join the Board.

在開始問答環節之前，我想花點時間歡迎我們董事會的新成員，（聽不清楚）格雷格是 Momenta 的前首席執行官，也是 Headwaters Biotech Advisers 的創始人兼首席執行官。他在生物製藥行業擁有超過 30 年的領導經驗，並成功地將公司發展成為擁有強大產品線的強大商業組織。他的專業知識將是一筆巨大的財富，我們很高興他能加入董事會。

With that, I'll turn the call over to the operator for Q&A.

說完這些，我將把電話轉給接線生進行問答。

(Operator Instructions) Jon Miller, Evercore.

（操作員指示）Jon Miller，Evercore。

Congrats on all the progress. I would love to just be really, really clear about 1Q volume dynamics, I guess, in my question. Obviously, there's a couple of moving parts to this. But I just want to sort of square the circle between your disclosures last quarter and your disclosures this quarter. So last quarter, aggregate volume was 94,000 vials.

祝賀你取得的所有進展。我想，我希望能夠非常清楚地說明我的問題中第一季的交易量動態。顯然，這其中涉及幾個活動部分。但我只是想將你們上個季度的披露與本季的披露進行比較。上個季度，總量為 94,000 瓶。

This quarter, it's 92,000, but your graph shows demand continuing to grow.

本季為 92,000，但您的圖表顯示需求持續成長。

Last quarter, you called inventory build not significant, I think, in your Q&A, and obviously, this quarter, you're saying it really was a more substantial change, the lack of funding to the co-pay assistance program was a known headwind we talked about last quarter, but it seems like maybe that's larger than it was expected. Do we know when that's going to roll off or how all of these dynamics are going to change as we move forward to the rest of the year. Can you just square those circles on volume changes 4Q to 1Q for me?

上個季度，您在問答中稱庫存建設並不重要，顯然，本季度您說這確實是一個更實質性的變化，共同支付援助計劃缺乏資金是我們上個季度談到的一個已知阻力，但似乎這可能比預期的要大。我們是否知道這一切何時會結束，或者隨著我們進入今年剩餘時間，所有這些動態將如何變化。您能幫我把體積變化從 4Q 變成 1Q 的那個圓圈畫出來嗎？

Thank you so much, Jon. Great to hear you. Well, I will hand it over to Tim for details, but what I want to stress is that we've had quarter-over-quarter growth in demand, as measured by the number of injections that are given to patients with geographic atrophy with Q1, as you correctly indicated, being the largest quarterly injection volume since the launch. That injection volume is a combination between commercial injections and sample injections. So that is the true measure of demand.

非常感謝，喬恩。很高興聽到你的聲音。好吧，我將把細節交給蒂姆，但我想強調的是，我們的需求呈季度環比增長，以給地圖樣萎縮患者註射的數量來衡量，正如您正確指出的那樣，第一季是自推出以來最大的季度注射量。此註射量是商業注射和樣品注射的組合。這才是真正的需求衡量標準。

And as you correctly alluded to as well, of course, samples are the ones that are mostly impacted by what is going on with the co-pay systems funding situation. I'll hand it over to Tim to talk more about the inventory.

當然，正如您正確提到的那樣，樣本是受共同支付系統資金狀況影響最大的。我將把它交給蒂姆來進一步討論庫存問題。

Sure. So there are a lot of questions within that question. I'll try to touch on what I think was your main question there, which is, so we had, as Cedric said, this 4% growth in injections, that injection growth constituted both commercial doses and sample doses, okay? Those are sample injections and commercial injections. So -- when you look at what we deliver, that's what's sent from -- if it's commercial doses, that's what's sent from the distributor to the physician.

當然。所以這個問題裡面還有很多問題。我將嘗試談談我認為你的主要問題，也就是說，正如塞德里克所說，注射量增長了 4%，注射量增長包括商業劑量和樣品劑量，好嗎？這些是樣品注射和商業注射。所以 - 當您查看我們交付的內容時，這就是從 - 如果是商業劑量，那就是從分銷商發送給醫生的內容。

That's different from what the physician puts in the eyes, right? That's an injection. So just let's make that distinction very clear.

這與醫生放入眼睛裡的東西不同，對嗎？那是注射。因此，讓我們明確區分這一點。

So we saw what we had was an inventory build at the end of Q4, both at the ECP level. So that's at the doctor's offices and their fridges and at the specialty distributor. So what we saw in Q1 was a wind down of that inventory at the ECP level, right, which went to injections into the eye, we also saw an increase in the number of samples as a result of the switch that came from the underfunding of the co-pay assistance organizations. So that also impacted how much these doctors were ordering from the specialty distributors. So we had a drawdown.

因此，我們看到第四季末的庫存有所增加，兩者都處於 ECP 水平。這就是在醫生辦公室和他們的冰箱以及專業經銷商處。因此，我們在第一季度看到的是 ECP 級別的庫存減少，對吧，這些庫存用於注射到眼睛中，我們還看到由於共同支付援助組織資金不足而導致的轉換，樣本數量有所增加。因此這也影響了這些醫生從專業經銷商訂購的數量。因此我們縮減了開支。

That's where you see this reduction in vials delivered, right? That came from -- that lower demand for vials delivered was because of the increase in inventory at the ECP level. They had to wind that down. So that's why you're seeing a difference between vials delivered and the injection growth that we saw. I don't know if that clarifies your question or if there's some other piece to it, but that's where the discrepancy lies.

這就是您看到運送的小瓶數量減少的原因，對嗎？這是因為——交付的小瓶需求下降是由於 ECP 水準的庫存增加。他們必須停止這項行動。這就是為什麼您會看到交付的小瓶子和我們看到的注射增長之間存在差異。我不知道這是否澄清了您的問題，或者是否還有其他問題，但這就是差異所在。

Sure. That makes sense. But how does this -- like how should we think about that going forward into the future with sampling volumes presumably continuing to remain high?

當然。這很有道理。但是，在採樣量可能繼續保持高水準的情況下，我們應該如何看待未來的這種情況？

Yes. So what we saw was we saw a drawdown in the total channel. This ended up having -- this ended up impacting not only the increase in inventory at the ECP level but also at the distributor. We don't know exactly where the world will end up from an inventory perspective, but what we can tell you is that inventory at the end of the first quarter looked a lot like inventory in prior quarters, excluding obviously the fourth quarter. So going forward, the impact really from a demand perspective, really is there's this ongoing use of samples we expect.

是的。因此，我們看到的是整個通道的下降。這最終不僅影響了 ECP 等級的庫存增加，還影響了經銷商的庫存增加。從庫存角度來看，我們不知道世界最終會走向何方，但我們可以告訴你的是，第一季末的庫存與前幾季的庫存非常相似，顯然第四季度除外。因此，展望未來，從需求角度來看，其影響實際上是我們預期樣品的持續使用。

It's roughly about the same as what we saw in the first quarter. And then from a commercial perspective, we hope to be basically at a baseline right now.

這與我們在第一季看到的情況大致相同。然後從商業角度來看，我們希望現在基本上處於基線。

So you're not expecting this co-pay assistance underfunding issue to be resolved anytime soon?

所以您不認為共同支付援助資金不足的問題能夠很快解決嗎？

We're not expecting that to be resolved anytime soon. But I think when you get to this inventory impact and vials doses delivered, right? Those were the 2 concepts you were talking about. Those should be on a more normal and steady state going forward, excluding, obviously, what's shifted to samples and over time, it would be great, and David can comment on the potential to switch those samples to commercial over time.

我們並不期望這個問題能很快解決。但我認為當您了解庫存影響和交付的小瓶劑量時，對嗎？這就是您所談論的兩個概念。這些在未來應該處於更加正常和穩定的狀態，顯然不包括轉移到樣品中的東西，隨著時間的推移，這將是很棒的，大衛可以評論隨著時間的推移將這些樣品轉換為商業的可能性。

Jon, it's David. Thanks for the questions, and I appreciate the discussion this morning. we are working diligently to understand and we know where the samples are being used in place of commercial injections. And one of the things that we have done is we've done a lot of work with the offices to make sure that we're educating the practices around the patient benefit designs.

喬恩，我是大衛。感謝您的提問，我很感謝今天上午的討論。我們正在努力了解，我們知道在哪裡使用這些樣本來代替商業注射。我們所做的一件事是與各辦公室開展了大量工作，以確保我們圍繞患者福利設計進行實踐教育。

And we've actually got some new programs and other work that's being put in place by the teams inside those offices so that we can transition those patients that are on samples over to commercial paid for doses that are being used. So the work is in progress. And over time, I think we'll see that shift. But right now, we do anticipate the samples to be about the same.

實際上，我們已經有一些新的計劃和其他工作正在由這些辦公室內的團隊實施，以便我們可以將那些使用樣本的患者轉變為使用商業付費劑量的患者。這項工作正在進行中。隨著時間的推移，我認為我們會看到這種轉變。但目前，我們確實預期樣本大致相同。

Tazeen Ahmad, Bank of America Securities.

Tazeen Ahmad，美國銀行證券。

I do want to ask about your calculation of new patient share. It does seem a little bit different than the calculation your competitor stated on their, I guess, press release a few weeks ago or a couple of weeks ago. Can you tell us how you derive share with new patients.

我確實想問一下您對新患者份額的計算。它看起來確實與您的競爭對手在幾週前或幾週前的新聞稿中所述的計算略有不同。您能告訴我們您是如何與新患者分享的嗎？

And then how are you thinking about the potential for providing sales guidance. Again, the competing product company has issued sales guidance, which seems to assume pretty steep uptick going forward. you're not responsible for their guy, but what would you need to feel comfortable with on your end to provide sales guidance for SYFOVRE?

那麼您如何看待提供銷售指導的潛力？再次，競爭產品公司已經發布了銷售指南，似乎表明未來將大幅成長。您不對他們的員工負責，但是您需要對什麼感到滿意才能為 SYFOVRE 提供銷售指導？

Thank you, Tazeen. I will hand the first part of your question over to David, and then Tim will talk about guidance.

謝謝你，塔津。我將把你的問題的第一部分交給大衛，然後蒂姆將談論指導。

Tazeen, thanks for the question this morning. So one of the things that we do is we purchased a site of care data set that covers about 50% of the market that's very accurate. And we feel our data sets are as accurate as you can get in the space. We know our competitor talked about claims database type of data, which we know is not as accurate and only covers a small portion of the market.

Tazeen，感謝您今天早上提出的問題。因此，我們所做的事情之一就是購買一個涵蓋約 50% 市場的護理資料集，該資料集非常準確。我們認為我們的數據集是您在太空中可以獲得的最準確的數據集。我們知道我們的競爭對手談論的是索賠資料庫類型的數據，我們知道這些數據不太準確，而且只涵蓋了一小部分市場。

At a high level, what we're focused on is growing the site leadership position, which we're clear on doing. And you can see that in the new patient starts growth. And we're trying to grow the market as quickly as we possibly can around that. So we've launched several near-term initiatives and long-term initiatives to manage through that, which we can certainly talk about. I'll hand it over to Tim on the guidance part.

從高層次來看，我們關注的是提升站點的領導地位，我們對此有明確的目標。您可以看到新患者的身體開始成長。我們正努力盡快擴大該市場。因此，我們推出了幾項短期計劃和長期計劃來解決這個問題，我們當然可以談論這些。我會將指導部分交給提姆。

Sure. Thanks, Tazeen. From a sales guidance perspective, we've obviously had a couple of pretty big dynamics happen over the last two quarters. We had the CRL for the competitor, and we also had this underfunding in of patient co-pay assistance organizations. So I think we really need to enter more of a steady state before we think about guiding around SYFOVRE.

當然。謝謝，Tazeen。從銷售指導的角度來看，過去兩個季度我們顯然經歷了一些相當大的動態。我們有競爭對手的 CRL，而且我們在病人共同支付援助組織方面的資金也不足。因此我認為在考慮引導 SYFOVRE 之前，我們確實需要進入更穩定的狀態。

Married with that, we also have a new launch of C3G and IC-MPGN, which we're really excited about, but which comes with a little bit of how big is this in we'll -- when we feel comfortable guiding, we probably want to guide on both products. So -- that's probably the best thing to be right now.

同時，我們也推出了新的 C3G 和 IC-MPGN，我們對此感到非常興奮，但這也帶來了一些問題——當我們覺得可以指導時，我們可能希望對這兩種產品進行指導。所以——這可能是目前最好的事。

And just maybe 1 brief touch test what you mentioned as well. I mean for us, what is most encouraging is how quarter after quarter since the early fall, we keep gaining on that new patient share, right? So the relative evolution over time creates a very clear trend for us.

也許只需進行一次簡單的觸控測試就可以了。我的意思是，對我們來說，最令人鼓舞的是，自初秋以來，我們每季都在增加新病患的比例，對嗎？因此，隨著時間的推移，相對的演變為我們創造了一個非常清晰的趨勢。

So I did want to follow up on that, Patrick. I think the reason why people would like to see you provide sales guidance is because there's a question about how big the -- the number of patients is large in GA, but how much of it is actually addressable in this market. I think people are trying to figure that out. And one of the two companies has provided what their view of what they think they'll do this year is. But when do you think -- forget about C3G, let's talk about SYFOVRE, which is a much more mature launch.

所以我確實想跟進這一點，帕特里克。我認為人們希望看到您提供銷售指導的原因是因為存在一個問題，即 GA 中的患者數量有多大，但其中有多少實際上可以在這個市場上解決。我認為人們正在試圖弄清楚這一點。兩家公司中的一家已經表達了他們對今年計劃的看法。但您什麼時候會想到——忘記 C3G，讓我們來談談 SYFOVRE，它是一款更成熟的產品。

When do you think -- I mean is it possible at all this year that you would feel comfortable?

您認為什麼時候——我的意思是今年您有可能感到舒服嗎？

No, I don't think it's likely we'll provide guidance this year. We don't do an interim guidance. We'll consider it probably towards the end of the year or next year, but we're not committing to it.

不，我認為我們今年不太可能提供指導。我們不做臨時指導。我們可能會在今年年底或明年考慮這個問題，但我們不會承諾這麼做。

And I think that just kind of to the broader point of adoption. We see, as you see quarter-over-quarter that growth is there, it's steady. It's a new space, a new disease indication, new therapeutic modality. These things take time to find a place of adoption. But as you correctly outlined, only a very small portion of patients with geographic atrophy have been treated so far.

我認為這在某種程度上代表了更廣泛的採用。我們看到，正如您所看到的，季度環比增長是存在的，而且是穩定的。這是一個新的領域、新的疾病指徵、新的治療方式。這些東西需要時間來找到被採用的地方。但正如您正確概述的那樣，到目前為止，只有極少數地圖狀萎縮患者得到了治療。

And the shift that we see gradually in the community of physicians is meaningful. Maybe Caroline is here with us, you can maybe briefly comment on this as well.

我們在醫生群體中看到的逐漸轉變是有意義的。也許卡羅琳 (Caroline) 和我們在一起，您也可以對此發表簡短的評論。

Thank you, Cedric. Hi Tazeen, I think that similar to the wet AMD market, which started in a similar way that it took physicians a little bit of time to adopt the treatment, the anti-VEGF treatments. But there's continually more patients to treat. It doesn't stop, that we'll find the same thing with GA patients. I mean it's the same population, patients develop both diseases in both eyes, and there's a lot of overlap.

謝謝你，塞德里克。你好，Tazeen，我認為這與濕性 AMD 市場類似，其起步方式類似，醫生需要一點時間來採用這種治療方法，即抗 VEGF 治療方法。但需要治療的病人卻越來越多。這種現象並不會停止，我們會在 GA 患者身上發現同樣的情況。我的意思是，他們是同一個群體，患者的雙眼都會患上這兩種疾病，而且有很多重疊之處。

So I think this market will continue to grow, and that's based on my experience as well.

所以我認為這個市場將繼續成長，這也是基於我的經驗。

Anupam Rama, JPM.

阿努帕姆·拉瑪（Anupam Rama），JPM。

Can you help us understand a little bit the payer landscape post the label update for SYFOVRE? And what are the strategies to get some formulary wins here on the payer side?

您能否幫我們了解一下 SYFOVRE 標籤更新後的付款人情況？那麼，在付款方方面，有哪些策略可以取得處方藥的勝利呢？

Great hearing you. Let me hand that over to David to answer.

很高興聽到你的聲音。讓我把這個問題交給大衛回答。

Anupam, it's David. Thank you for the question. So we have been very open and very clear that we've had preferred positioning with SYFOVRE on a number of plans, in particular, some of the large Medicare advantage plans, and that continues to exist. We haven't seen significant changes with the label update that's happened with our competitor.

阿努帕姆，我是大衛。謝謝你的提問。因此，我們非常公開且明確地表示，我們在許多計劃中與 SYFOVRE 處於優先地位，特別是一些大型醫療保險優勢計劃，而且這種地位仍然有效。我們尚未看到與競爭對手相比標籤更新有顯著的變化。

And in particular, I think what really drives a big part of that is that we have efficacy data with every other month dosing or up to as few as 6 doses a year. So a major differentiator for us with our data and with our label. But it's -- we continue to see preferred positioning and nothing has changed moving into this year.

特別是，我認為真正推動這一進程的是我們擁有每隔一個月注射一次或每年最多注射 6 次的療效數據。因此，我們的數據和標籤之間存在一個主要區別。但我們繼續看到優先定位，而且今年的情況沒有任何變化。

Salveen Richter, Goldman Sachs.

薩爾文·里克特，高盛。

This is on for Salveen. So could you speak to -- this is with regard to (inaudible) where you're initiating a Phase II study with SYFOVRE in 2Q. Could you speak to the magnitude of expected benefit from this combination versus SYFOVRE alone?

這是 Salveen 的。那麼您能談談——這是關於（聽不清楚）您將在第二季度與 SYFOVRE 啟動第二階段研究。您能否談談這種組合與單獨使用 SYFOVRE 相比預期帶來的效益有多大？

Thank you so much for that question. So I quickly repeat it because your line was a little bit muted. So the question was whether our 3007 program, where we combine a subcutaneous injection with an siRNA product that brings the systemic C3 levels down by approximately 90%. If when we combine that with the injection for SYFOVRE, which we will -- we are currently doing, as you know, every 2 months, but we plan to also test within every 3-month injection.

非常感謝您提出這個問題。所以我很快重複了一遍，因為你的台詞有點低沉。所以問題是我們的 3007 計劃，我們將皮下注射與 siRNA 產品結合，使全身 C3 水平降低約 90%。如果我們將其與 SYFOVRE 注射結合起來，我們將會——正如你所知，我們目前每 2 個月進行一次，但我們計劃在每 3 個月的注射中進行測試。

So a combination of intravitreal administration with this new product subcutaneously -- and the question is, what is the magnitude of benefit that we can expect from that. So this is a very exciting program for us. I think that this will be -- we obviously believe that this will be the next big innovation in this space in geographic atrophy.

因此，將玻璃體內給藥與皮下注射這種新產品結合在一起——問題是，我們可以從中期待多大的益處。所以這對我們來說是一個非常令人興奮的項目。我認為這將是——我們顯然相信這將是地理萎縮領域的下一個重大創新。

We believe that the protection that SYFOVRE has on for receptor cells by the analysis that we have done on the photoreceptor cells specifically is pretty much as good as it can be. The protection of the layer below that, which are the retinal pigmented epithelial cells, we have increasing effects over time, slowdowns of 30% to 40%, even the way there, we think we can further improve and have an impact beyond that 40% thresholds that we're bumping into right now.

我們相信，透過我們對感光細胞的分析，SYFOVRE 對受體細胞的保護幾乎是最好的。對其下層的保護，即視網膜色素上皮細胞，隨著時間的推移，其影響越來越大，減慢了 30% 到 40%，即使在這種情況下，我們認為我們可以進一步改進，並產生超越我們現在遇到的 40% 閾值的影響。

So if we're going to get north of 50%, that would be an important improvement. We are also going to use these next clinical trials to apply everything that we learned in terms of how you can measure the functional impact on vision with these therapies and we're able to assess that much better than we have been able to do and invest.

因此，如果我們要達到 50% 以上，這將是一個重要的進步。我們還將利用接下來的臨床試驗來應用我們所學到的一切，即如何衡量這些療法對視力的功能影響，並且我們能夠比以往做得和投資做得更好。

Steve Seedhouse, Cantor.

史蒂夫‧西德豪斯 (Steve Seedhouse)，領唱。

I wanted to ask specifically about I appreciate the comments that you're not expecting a near-term resolution to the charity, the co-pay assistance situation. But the question is, are you in dialogue with other industry members seeking a solution, it sounded like Regeneron was open to contributing again either to good days or to some -- a new entity, something similar what basically wanted others in the industry to pony up as well. So are you in dialogue with folks, Regeneron or others? And is Apellis willing to pay some prorated amount along with other industry members into good days or some similar charity to bring that back online?

我想特別問一下，我很感激您不期望慈善機構在短期內解決共同支付援助問題的評論。但問題是，您是否正在與其他行業成員對話以尋求解決方案，聽起來 Regeneron 願意再次做出貢獻，無論是對好日子還是對某些新實體，類似的東西，基本上希望業內其他人也付出代價。那麼，您是否正在與 Regeneron 或其他人進行對話？Apellis 是否願意與其他行業成員一起向 Good Days 或類似的慈善機構支付一定比例的金額，以使其重新上線？

Thank you so much, Steve, for that question. So the answer to that question is no. we respect the full independence of the co-funding co-pay organizations. We do contribute to them typically at the beginning of the year. But sometimes that can also happen throughout the year.

非常感謝史蒂夫提出這個問題。所以這個問題的答案是否定的。我們尊重共同資助共同支付組織的完全獨立性。我們通常在年初向他們做出貢獻。但有時這種情況也可能全年發生。

But we keep that as entirely dissociated contribution from what we do, obviously, with SYFOVRE as commercial products.

但我們認為這與我們所做的完全無關，顯然，SYFOVRE 是商業產品。

Colleen Kusy, Baird.

科琳·庫西，貝爾德。

Maybe a follow-up on that. What do you see as the risk of the third-party co-pay assistance headwind -- the third-party co-pay assistance program coming back at all? Do you think that that's definitely going to happen? Or is that a risk that might -- that part of the business might go way completely.

或許可以對此進行跟進。您認為第三方共同支付援助逆風的風險是什麼－第三方共同支付援助計畫的回歸？您認為這一定會發生嗎？或者這是一種風險，即部分業務可能會完全失敗。

Thank you, Colleen. Over to David.

謝謝你，科琳。交給大衛。

Yes. Colleen, look, thank you for the question, first of all, we are -- we don't know it's unpredictable, right? I don't know what will happen with the fund the foundation overall. We have taken the approach that we anticipate, and we're working under the assumption that it won't. And that's why we do anticipate our sampling and our injections to continue to grow, but the balance between samples and commercial doses that are out there will be balanced a little bit differently.

是的。科琳，聽著，謝謝你的提問，首先，我們──我們不知道這是不可預測的，對吧？我不知道基金會的整體資金狀況會如何。我們已經採取了預期的方法，我們假設這種情況不會發生。這就是為什麼我們確實預計我們的採樣和注射將繼續增長，但樣品和商業劑量之間的平衡將會略有不同。

So that's where we sit on the -- on our observations of it.

這就是我們對此的觀察。

Phil Nadeau, TD Cowen.

菲爾·納多 (Phil Nadeau)，TD Cowen。

This is Alex on for Phil. Could you comment maybe on the potential tariff exposure for SYFOVRE and EMPAVELI? And to what extent is manufacturing located ex U.S. also where is Apellis' key IP domicile?

這是亞歷克斯 (Alex) 代替菲爾 (Phil) 發言。您能否評論一下 SYFOVRE 和 EMPAVELI 的潛在關稅風險？製造業務在多大程度上位於美國境外？ Apellis 的主要智慧財產權所在地在哪裡？

Thanks. This is Tim. I'll take the question. Appreciate it. Unfortunately, there's not much we can say to any of the really 3 parts to your question.

謝謝。這是蒂姆。我來回答這個問題。非常感謝。不幸的是，對於您問題的三個部分，我們都無話可說。

So first, we're analyzing any potential exposure to tariffs. And obviously, mitigation tactics under these multiple tariff scenarios are being evaluated, and we'll provide updates when we can on that, but we really don't have much more information.

因此，首先，我們要分析任何潛在的關稅風險。顯然，我們正在評估這些多重關稅情景下的緩解策略，我們會在可能的情況下提供最新信息，但我們確實沒有更多信息。

We do talk about -- and we have disclosed where our drug substance for SYFOVRE is manufactured, which is a Bakken and that are not or drug intermediate where that is produced. So those are Switzerland and Japan, respectively. We haven't disclosed we work with on drug product nor have we disclosed where our IP is domiciled. So I'm afraid there's not a lot to tell you on those answers.

我們確實談論過——並且我們已經披露了 SYFOVRE 藥物的生產地點，即巴肯 (Bakken)，而不是生產該藥物的中間體。這兩個國家分別是瑞士和日本。我們沒有透露我們在藥品方面的合作，也沒有透露我們的智慧財產權所在地。因此，恐怕對於這些問題的答案，我沒有什麼可以告訴你的。

Eliana Merle, UBS.

瑞銀的 Eliana Merle。

Just looking at the revenues reported versus the amount of commercial vials that you shipped -- it does look like the net price per vial has come down a bit. Can you just help us understand the dynamics here and what you saw with net price in 1Q? I know you commented you expect gross to net in the low to mid-20s over 2025. But can you just clarify how that could potentially vary quarter-to-quarter and what you saw specifically in 1Q? And then I have a follow-up question after to be a lot of those.

僅查看報告的收入與您運送的商業小瓶數量相比——看起來每瓶的淨價確實有所下降。您能否幫助我們了解這裡的動態以及您看到的第一季淨價情況？我知道您曾評論說，您預計 2025 年的毛利將在 20% 左右。但是您能否解釋一下每個季度之間可能會出現哪些變化，以及您在第一季具體看到了哪些變化？然後我有一個後續問題，有很多這樣的問題。

Okay. So first, let me start out with the difference between revenue recognizing and then vials shipped or doses shipped as we disclose it. So the first thing is we recognize revenue when a dose is shipped to the distributor. That's not what we're disclosing to you. in terms of vials shipped or doses shipped.

好的。首先，讓我先介紹一下收入確認與我們揭露的出貨小瓶或出貨劑量之間的差異。因此，我們首先在劑量運送給分銷商時確認收入。就運送的小瓶或劑量而言，這並不是我們要向您披露的內容。

That's from a distributor to the doctor.

這是經銷商寄給醫生的。

So those are disconnected and you can't back into the price in that price that way, okay? So that's the first thing. And we talked about some of the inventory dynamics that changed how those ordering patterns were happening for the physician from the distributor. Again, that's what we disclosed, but that's not what the revenue recognition comes from. So I hope that answers your question.

所以它們是斷開的，你不能以那種方式回到那個價格，好嗎？這是第一件事。我們討論了一些庫存動態，這些動態改變了醫生與經銷商之間的訂購模式。再說一次，這就是我們揭露的內容，但這不是收入確認的來源。我希望這能回答你的問題。

But from a gross to net perspective, we were on the low end of the 20% to 25% range this quarter. And it does fluctuate obviously gave the guidance a bit through the end of the year between -- it would be between 20% and 25% or low to mid-20s.

但從總額到淨額的角度來看，本季我們的成長率處於 20% 至 25% 區間的低端。而且它確實會有所波動，顯然，到年底的預測會略有波動——介於 20% 到 25% 之間，或 20% 左右。

Great. That's helpful. And then just in terms of like the demand growth, can you just elaborate a little bit more on what you're seeing in 2Q so far? So this 4% injection growth that you saw in 1Q, I guess, is this fair for us to assume going forward in terms of injection growth and how you're thinking about that?

偉大的。這很有幫助。那麼就需求成長而言，您能否詳細說明一下到目前為止第二季的情況？所以，我想，您在第一季看到的 4% 的注入成長率，對於我們未來注入成長率的假設來說，這是否公平，您對此有何看法？

Thank you so much for that question, so again, without providing guidance, I think what is really important here, what you picked up on is that this quarter-over-quarter amount as measured by the number of injections that are given to the number of patients that are out there continues to grow. And last quarter, consequently was the largest quarterly injection volume that we saw. That is not something that we expect to change.

非常感謝您提出這個問題，所以再次強調，在不提供指導的情況下，我認為這裡真正重要的是，您所了解到的是以給患者註射的次數來衡量的這個季度環比數量持續增長。因此，上個季度是我們看到的最大季度注入量。我們並不期望這一點會改變。

We are very early in the launch still in many ways, only a small percentage of patients have been treated. And as Caroline alluded to earlier, this is something where when you speak with physicians that have properly adopted the products, you will find the numbers ranging all the way from (inaudible) between 30% and 50% of my patients with geographic atrophy. So we're only in the very beginning stages. And I think as physicians become comfortable with understanding the mechanism of disease, the drug that will continue to grow.

從很多方面來看，我們的研究還處於起步階段，只有一小部分患者接受了治療。正如卡羅琳之前提到的，當你與正確採用這些產品的醫生交談時，你會發現患有地圖狀萎縮的患者比例從（聽不清楚）的 30% 到 50% 不等。所以我們才處於起步階段。我認為，隨著醫生對疾病機制的理解不斷深入，這種藥物將會持續成長。

One thing that we're doing is we're introducing tools to help physicians and patients realize the benefits of our product and being able to pull these into practice, we've presented on a GA prediction tool. We're working across multiple imaging and AI studies to give the physicians the tools that they need for their patients.

我們正在做的一件事是引入工具來幫助醫生和患者認識到我們產品的好處，並能夠將這些好處付諸實踐，我們已經提出了一個 GA 預測工具。我們正在進行多項影像和人工智慧研究，為醫生提供治療患者所需的工具。

Annabel Samimy, Stifel.

安娜貝爾·薩米 (Annabel Samimy)，Stifel。

Just going back to the issue of the inventory. I realize that you get some build in the fourth quarter around the holidays, but you didn't know last quarter that it wasn't outside of the 2- to 3-week norm. So maybe you can help us understand the extent to which the build was from the (inaudible) and not being comfortable with that with that product for -- during that period and now seeing drawdown based on more comfort with serve with the label expansion have the conversations changed at all since their label update? And maybe I missed this, but maybe you can quantify what that inventory impact was?

回到庫存問題。我知道你們在第四季假期前後會有一些建設，但你們不知道上個季度它並沒有超出 2 到 3 週的常態。所以也許你可以幫助我們了解構建的程度來自（聽不清楚）並且對該產品感到不舒服 - 在那段時間裡，現在看到基於對標籤擴展服務的更多舒適度而下降，自從他們的標籤更新以來，對話是否有所改變？也許我忽略了這一點，但也許您可以量化庫存影響是什麼？

Sure, Annabel. I'll start and then I'll give -- hand it over to David for what the latest conversations are with the physicians on this topic. But in terms of what we saw in December, right after the CRL, we saw a sharp increase in demand for SYFOVRE, okay? That is in terms of doses ordered to the physician's offices but it also correlated to 3 very important metrics. The first was an increase in set retotal injections in December.

當然，安娜貝爾。我先開始，然後交給大衛，讓他報告一下與醫生們就這個主題進行的最新對話。但就我們 12 月看到的情況而言，CRL 結束後，SYFOVRE 的需求急劇增加，好嗎？這是根據醫生辦公室開出的劑量計算的，但它也與 3 個非常重要的指標有關。首先是12月份設定的總注入量增加。

The second 1 was an increase in new patient share of injections. And you've seen that continue, obviously, in the chart that is in the deck. And then finally, we saw a sharp increase in switches from the competitor product. So all of these things together contribute to the increase in inventory that we saw.

第二個是新病患注射份額的增加。顯然，在卡片上的圖表中，你已經看到這種情況繼續發生。最後，我們看到競爭產品的轉換量急遽增加。所有這些因素共同導致了我們所看到的庫存增加。

Now in Q1, we saw this drawdown to more typical levels, and that was probably impacted further by the underfunding of this co-pay assistance organization dynamic that we talked about. But there's no question that the CRL for the competitor as well as the more limited label that they achieved has really changed that conversation. So with that, I'll turn it over to David to talk a little more about that conversation.

現在在第一季度，我們看到這種下降趨勢已經到了更典型的水平，而這可能進一步受到了我們之前談到的共同支付援助組織資金不足的影響。但毫無疑問，競爭對手的 CRL 以及他們獲得的更有限的標籤確實改變了這個話題。因此，我將把話題交給大衛，讓他進一步談論那次談話。

So Tim mentioned that one of the dynamics that we benefited from and took an opportunity to gross SYFOVRE was the CRL and the label situation and the regulatory situation that our competitor was under. And obviously, that drove some business for us. And actually, we continue to benefit from that. In the offices, I can tell you there's definitely more of a covered level that the product, the competitive product will be reimbursed. But here's our differentiator, right?

因此，蒂姆提到，我們受益並藉此機會使 SYFOVRE 盈利的動力之一是 CRL 和標籤情況以及我們的競爭對手所處的監管情況。顯然，這為我們帶來了一些業務。事實上，我們繼續從中受益。在辦公室裡，我可以告訴你，該產品的覆蓋範圍肯定比競爭產品要廣，而且可以獲得報銷。但這就是我們的區別所在，對吧？

This is both with the physicians and with the payers.

這既與醫生有關，也與付款人有關。

We are the only product that's got on every other month dosing opportunity with high efficacy. And that's a separator both with the physicians and patients as well as at the payer level. So even though there was a label change that opened up the 12-month restriction for our competitive product, we clearly have benefits that they do not have, and that's where we're growing the business today.

我們是唯一每隔一個月就獲得一次給藥機會且功效極高的產品。這是醫生和患者以及付款人之間的區別。因此，儘管標籤變化導致我們的競爭產品面臨 12 個月的限制，但我們顯然擁有他們所不具備的優勢，而這正是我們今天業務成長的地方。

Biren Amin, Piper Sandler.

比倫阿明、派珀桑德勒。

You mentioned that samples increased about 5,000 vials quarter-over-quarter. I assume that the increase was largely due to the foundation. So can you maybe confirm that, that increase quarter-over-quarter was due to the fact that there wasn't a co-pay assist through the foundation. And I guess moving -- going forward, should we expect that your samples will continue to grow as new patient growth continues, and you'll have more patients go on examples without having a co-pay assist?

您提到樣本數量比上一季增加了約 5,000 瓶。我認為成長很大程度上是由於基金會的緣故。那麼，您能否確認，季度環比增長是由於基金會沒有提供共同支付援助。我想，展望未來，我們是否應該預期，隨著新患者的不斷增長，您的樣本將繼續增長，並且會有更多的患者無需共同支付費用即可獲得樣本？

Thank you, Biren. I will hand it over to David to speak about kind of the trends moving forward and what we expect and how we're working on that. But I think it's important for you to remember that when a physician administers is central to patients, they make significantly less revenue than if they actually administer a commercial injection to a patient.

謝謝你，Biren。我將把時間交給大衛，讓他談談未來的趨勢、我們的期望以及我們如何為此努力。但我認為你必須記住，當醫生為患者進行注射時，他們的收入遠低於他們實際為患者進行商業注射的收入。

And what that indicates to you and I think this is important is that physicians guarantee about patients, they care about following up the treatment. They care about bringing new patients on it. Even if that patient is not able to pay that co-pay that physicians are trying to find ways to still treat these patients. And remember, again, this probably affects up to as much as 20% of the population. Now -- the goal moving forward is how are we going to switch as much as possible from samples to commercial.

這向你表明——我認為這很重要——醫生保證病人的安全，他們關心後續治療。他們關心的是帶來新的病人。即使患者無力支付共同費用，醫生也在想辦法治療這些患者。請記住，這可能會影響多達 20% 的人口。現在——我們前進的目標是如何盡可能地從樣品轉向商業。

And David will speak briefly to that.

大衛將對此進行簡要的講解。

That's great. Thank you, Cedric. And look, I also look at samples as true demand, right? So it could have been easy for physicians to not use a sample based on the ones that we just talked about. But what we're doing to mitigate the issues as a couple of things.

那太棒了。謝謝你，塞德里克。而且你看，我也將樣品視為真正的需求，對嗎？因此，醫生可能很容易不使用我們剛才討論的樣本。但我們正在採取一些措施來緩解這些問題。

We are working specifically with the practices inside the reimbursement discussions, but we're also doing educational programs that have been updated for practice managers to talk to other practice managers about making sure that the benefit programs that -- or the benefit design programs that these patients are on, we can find ways to transition them from the samples to the commercial doses and that is efforts that are currently underway and have been since the middle of Q1.

我們正在專門針對報銷討論中的實踐開展工作，但我們也在實施已更新的教育計劃，以便實踐經理與其他實踐經理進行交談，以確保這些患者所參與的福利計劃或福利設計計劃，我們可以找到方法將他們從樣品過渡到商業劑量，這是目前正在進行的努力，自第一季度中期以來一直在進行。

Yigal Nochomovitz, Citigroup.

花旗集團的 Yigal Nochomovitz。

Just curious about the co-pay situation. What is your level of visibility on that resolving and the funding gap going away in the ophthalmology sector.

只是好奇共同支付的情況。您對解決這個問題以及消除眼科領域資金缺口的看法如何？

Thank you. David?

謝謝。戴維？

Good to hear from you. It's like we talked about a few minutes ago, we aren't real sure it's not predictable at all and what will happen with the funding issue that's out there with the copay-assistance program. What we are doing is assuming that it will not be resolved, and that's how we're operating moving forward.

很高興收到你的來信。就像我們幾分鐘前談到的一樣，我們並不確定它是否完全不可預測，以及共同支付援助計劃的資金問題將會發生什麼。我們所做的就是假設這個問題不會被解決，而這就是我們今後的運作方式。

And for us, it's about making sure we transition patients from the samples to a commercial dose as quickly as possible where we can educate offices to do that based off the benefit design and the plans that these patients are on. So those are the efforts currently underway.

對我們來說，這是為了確保我們盡快將患者從樣本過渡到商業劑量，我們可以根據這些患者所採用的福利設計和計劃來教育辦公室這樣做。這些就是目前正在進行的努力。

Okay. And could you talk a little bit about your launch plans in C3G and IC-MPGN, what are you working on now to have a strong launch out of the gates and have a differentiated message versus the oral competitor.

好的。您能否簡單談談您在 C3G 和 IC-MPGN 上的發布計劃？您目前正在進行哪些工作，以便強勢推出產品，並與口頭競爭對手傳達出差異化的訊息。

Yes. Great question. Thank you. So look, a couple of things. We are in a situation now where we have all field teams and all of our teams are currently and actively in the field working to profile accounts and to also understand the links between KOLs and where the patients are located.

是的。好問題。謝謝。那麼看，有幾件事。我們現在的情況是，我們所有的現場團隊都積極地在現場工作，以分析帳戶並了解 KOL 與患者所在地之間的聯繫。

We've got a very specific set of accounts that we're spending time with now to profile and understand we're in to launch and how to launch quickly.

我們有一組非常具體的帳戶，我們現在正在花時間分析和了解我們將要推出的產品以及如何快速推出。

The other thing that we're working through is making sure that everyone through our medical affairs team that would like to know and understand the data can do that. Our biggest differentiators, of course, in this market is the fact that our efficacy is twice that of the competitive product. And we also believe that efficacy in this space is going to drive decision-making, not the route of administration. So we're focused on that as well. And at the end of the day, the teams have been out there since April, and we've got until late July through PDUFA, and it's all about making sure that we're ready to go for launch as soon as we get approved.

我們正在努力的另一件事是確保我們醫療事務團隊中每個想要了解和理解數據的人都能做到這一點。當然，我們在這個市場上最大的差異化因素是我們的功效是競爭產品的兩倍。我們也相信，該領域的功效將推動決策，而不是管理途徑。所以我們也關注這一點。總而言之，團隊從 4 月就開始在那裡工作了，透過 PDUFA，我們的時間可以持續到 7 月底，這一切都是為了確保我們能夠在獲得批准後立即投入發布。

Douglas Tsao, H.C.Wainwright.

曹德華，H.C.溫賴特。

I guess, David, just given your sort of comments that you don't assume the foundation will come back online, I guess I'm trying to sort of understand some of the steps that you can take in terms of benefit design because presumably most of these patients have some coverage, it's just the out-of-pocket that they're not able to address. And so I'm not sure -- it just might be helpful to sort of understand some of the steps that you might be able to take to mitigate that impact?

我想，大衛，鑑於你的評論，你認為基金會不會重新上線，我想我正在嘗試了解你在福利設計方面可以採取的一些步驟，因為大概大多數這些病人都有一定的保險，只是他們無法解決自付費用的問題。所以我不確定——了解您可以採取哪些措施來減輕這種影響可能會有所幫助？

And do you see yourself being more or less affected than your competitor is the fact that you have sort of every other month dosing potentially become even more of an advantage in this environment for segments of the patient population.

並且，您認為自己受到的影響比競爭對手更大還是更小？事實上，在這種環境下，您每隔一個月的給藥可能會對部分患者群體更具優勢。

Absolutely. Thank you for the question. I think you answered part of the question at the end. So part of the advantage that we have is that we do have every other month dosing and high efficacy with that modality. And I think one of the things in those offices for patients that would struggle to pay a co-pay 12 times a year can do that as half as many times as that, which is great.

絕對地。謝謝你的提問。我認為你最後回答了部分問題。因此，我們的部分優點在於我們每隔一個月就會進行一次給藥，而且這種方式療效很好。我認為，這些辦公室為那些每年支付 12 次共同支付費用的患者提供的服務之一，可以將支付次數減少一半，這很好。

What we're doing to mitigate this is a couple of things to go a little bit deeper.

為了緩解這個問題，我們正在採取一些更深入的措施。

We have a reimbursement team as you're aware of in the field. They know benefit plans and designed by each one of these plans very, very well. One of the things that we do know about the reimbursement through the foundation is that in many times, patients were going on reimbursement through the foundation that didn't need to. And it was a situation where it was just a benefit design that was missed, and we're making sure we educate opposites, so they understand that down to the patient level.

如您所知，我們在該領域有一個報銷團隊。他們非常了解福利計劃以及每個計劃的設計。關於透過基金會報銷，我們確實知道的一件事是，很多時候，患者透過基金會進行報銷，但其實並不需要這樣做。在這種情況下，我們只是忽略了一個福利設計，而我們要確保我們教育了相反的人，以便他們能夠理解這一點，直至患者層面。

The other thing is we're using a peace assist, which is our patient hotline and it also works with our offices to help identify when these patients that have a benefit that will run -- when the out-of-pocket max is hit for a specific patient, we can help identify that for a specific patient and then work with the offices to get that patient in for treatment. So there's a fairly detailed plan behind the scenes that goes down to the patient level to help the offices manage with that.

另一件事是，我們正在使用和平援助，這是我們的患者熱線，它還與我們的辦公室合作，幫助確定這些患者何時可以享受福利 - 當特定患者的自付費用達到最高限額時，我們可以幫助確定特定患者的情況，然後與辦公室合作讓該患者接受治療。因此，幕後有一個相當詳細的計劃，深入到患者層面，以幫助辦公室進行管理。

Lachlan Hanbury-Brown, William Blair.

拉克蘭·漢伯里·布朗，威廉·布萊爾。

I guess -- your competitor mentioned that they've sort of seen some signs of market growth. And I know that's something that you've been investing in. So I was wondering if you can comment on is there anything you've seen that suggests that those efforts to kind of grow the market increase diagnosis and referrals are starting to bear fruit.

我猜——你的競爭對手提到他們已經看到了一些市場成長的跡象。我知道這是你一直在投資的事情。所以我想知道您是否可以評論一下，您是否看到任何跡象表明，擴大市場、增加診斷和轉診的努力開始取得成果。

Yes. Thank you for the question. This is David. So we are both working very diligently grow the market. We have DTC plans in place with -- as you know, for us, both on TV as well as digitally with Henry Winkler.

是的。謝謝你的提問。這是大衛。所以我們都在非常努力地拓展市場。我們已製定了 DTC 計劃——如您所知，對於我們來說，包括電視計劃以及與亨利溫克勒 (Henry Winkler) 合作的數位計劃。

We also have multiple different programs that are in place to help folks to identify patients that have GA, both in the treating offices, the nontreating offices.

我們也實施了多個不同的計畫來幫助人們識別患有 GA 的患者，無論是在治療辦公室還是非治療辦公室。

We also have a very rose bus team that's built to focus on optometry and ophthalmology offices that are not injecting and their sole purposes to educate on geographic atrophy, identifying the patients that have geographic atrophy and then having the opportunity for those patients to have information and some sort of referral into an office that is an injection office. And that is ongoing and has been ongoing since the first part of the year. So that's what we're working to do to grow the market and our competitors doing a number of like opportunities.

我們還有一個玫瑰巴士團隊，專門為不注射的驗光和眼科診所服務，他們的唯一目的是教育人們了解地圖狀萎縮，識別患有地圖狀萎縮的患者，然後讓這些患者有機會獲得信息，並通過某種方式轉診到注射診所。這個過程自今年年初以來就一直在進行。這就是我們正在努力擴大市場並讓我們的競爭對手獲得許多類似的機會。

What I can tell you is that the market has been relatively flat coming in Q1. But we've been able to grow our new-to-brand starts robustly since late last year, which gives us comfort that we're going to see continued growth in our brand as well as in the market moving forward.

我可以告訴你的是，第一季市場相對穩定。但自去年年底以來，我們的新品牌業務一直保持強勁成長，這讓我們感到欣慰，我們將看到我們的品牌以及市場繼續成長。

Ryan Deschner, Raymond James.

瑞安‧德施納、雷蒙‧詹姆斯。

How likely do you think it is that the impact of inventory drawdown in co-pay funding shortages continue to have a significant impact on 1Q net sales SYFOVRE going forward in subsequent first quarters. And then I have a follow-up.

您認為共同支付資金短缺造成的庫存減少的影響在接下來的第一季繼續對 SYFOVRE 第一季淨銷售額產生重大影響的可能性有多大？然後我有一個後續問題。

Sure. I'll take those questions. So there are always little inventory fluctuations. I really can't control -- but these 2 events, the first one, obviously, the CRO and the accelerated build that we saw in the fourth quarter, Obviously, that's a settled issue at this point.

當然。我會回答這些問題。因此庫存波動總是很小。我真的無法控制——但這兩個事件，第一個，顯然是 CRO 和我們在第四季度看到的加速建設，顯然，這是目前已經解決的問題。

And then in terms of the co-pay assistance organizations being underfunded, we look at that as sort of a onetime issue that has continued effect. So in that sense, there's no kind of event that's going to change any inventory dynamic. We would expect neither of these two things would impact inventory specifically going forward. And then can you tell us about your latest thinking on the impact of the new DTC campaign on sales across 2025.

至於共同支付援助組織資金不足的問題，我們認為這是一個持續影響力的一次性問題。因此從這個意義上來說，沒有任何事件能夠改變庫存動態。我們預計這兩件事都不會對未來的庫存產生特別的影響。然後您能否告訴我們您對新的 DTC 活動對 2025 年銷售的影響的最新看法。

Yes. So far, it's been very positive. And what we can see early because it started in January as a brand and direct-to-consumer campaign. We could see a very high spike in the additional hits to our website, which is kind of an early indicator metric that we look at before we can get robust data switches or information on patients that actually go to product.

是的。到目前為止，一切都非常積極。我們可以提前看到這一點，因為它是一月份作為品牌和直接面向消費者的活動啟動的。我們可以看到我們網站的額外點擊量大幅增加，這是我們在獲得可靠的數據轉換或實際使用產品的患者資訊之前查看的早期指標。

And as early as we are all of our metrics are up quite a bit. We're actually 30% higher this year just alone in Q1 than we were all year last year on average per quarter on the number of actually website visits as well as actions that people, either physicians or patients take beyond that. So it's been positive so far.

到目前為止，我們的所有指標都已大幅提升。事實上，光是今年第一季度，我們的網站流量以及人們（無論是醫生還是患者）採取的行動就比去年全年平均每季高出 30%。到目前為止，情況都是正面的。

Judah Frommer, Morgan Stanley.

猶大‧弗洛默，摩根士丹利。

Just a couple more on sampling dynamics. We're curious if you could help us with whether there's a sensible competition within sampling? Are you seeing the competitor provide more samples? And is there I guess, some inclination to compete with their level of sampling. And then separately, is there anything you can share on sampling into newer practices that you're penetrating versus existing customers?

關於採樣動態，再說幾點。我們很好奇您是否能幫助我們了解採樣過程中是否有合理的競爭？您是否看到競爭對手提供更多樣品？我猜想，他們是否有意與自己的採樣水準競爭。然後另外，您是否可以分享一些關於您正在滲透到現有客戶的新實踐的採樣情況？

Yes, no problem. Thank you. So let me first comment on our sampling efforts. So our sampling efforts are there for physicians to take advantage of in their offices when they have patients they want to treat -- and obviously, if the co-pay situation has gotten in the way from the foundation funding issue, they can certainly manage through that with an opportunity to treat patients that is readily available for all offices.

是的，沒問題。謝謝。因此，首先讓我評論一下我們的採樣工作。因此，當醫生有病人需要治療時，我們所做的抽樣工作可以讓醫生在辦公室裡充分利用這一優勢——而且顯然，如果共同支付的情況因基金會的資金問題而受到阻礙，他們當然可以通過為所有辦公室提供治療病人的機會來解決這個問題。

We can see it across both new and former traders -- and we do continue to add new treaters as we progress throughout the launch. So -- and samples are used in almost all offices across patients. I'm not going to comment on what we see from a competitive landscape, and we don't see that data specific to their sampling efforts -- but for us, we know that it's something that's a good tool for us to use under our current circumstances.

我們可以在新舊交易者身上看到這一點——而且隨著整個發布過程的推進，我們確實會繼續增加新的交易者。因此 — — 幾乎所有的診所都會為患者使用樣本。我不會對我們從競爭格局中看到的情況發表評論，我們也沒有看到特定於他們的抽樣工作的數據——但對我們來說，我們知道這是我們在當前情況下可以使用的一個很好的工具。

Greg Harrison, Scotiabank.

加拿大豐業銀行的格雷格·哈里森。

Maybe one on EMPAVELI. What are you seeing that led to the revenue decline this quarter. Any inventory issues here or something else involving demand? Just trying to understand that dynamic and what we could expect going forward.

也許 EMPAVELI 上有一個。您認為是什麼原因導致本季營收下降？這裡有任何庫存問題或其他涉及需求的問題嗎？只是想了解這種動態以及我們對未來的期望。

Yes. I will hand it over to Ted for additional details. But -- we are actually very happy with the stable situation that we found in PNH, where as you know, there was an oral competitor that came in a little over a year ago. It would be very good for us.

是的。我將把它交給泰德以獲取更多詳細信息。但是——我們實際上對 PNH 的穩定局面感到非常高興，正如你所知，一年多前，這裡出現了一個口服競爭對手。這對我們來說非常好。

I mean, we have a stable business in PNH, where we've actually had several patients that went to the oral product and then decided to come back to kind of bearing witness to the remarkable efficacy and safety profile of that drug in PNH. With the new launch coming up in C3G and IC-MPGN, that, of course, will, we believe, turn EMPAVELI into our second blockbuster opportunity.

我的意思是，我們在 PNH 擁有穩定的業務，實際上我們已經有幾位患者使用了口服產品，然後決定回來見證該藥物在 PNH 中的顯著療效和安全性。隨著 C3G 和 IC-MPGN 的新產品發布，我們相信，這將使 EMPAVELI 成為我們的第二個重磅機會。

We're really excited about what we're seeing there. We estimate approximately 5,000 patients just in the U.S., 8,000 patients ex U.S. And I want to point out again that because of the breadth of patients that we studied in being adolescents, C3G and pre-transplant and post transplant. We may end up competing only for maybe 1,500 to 2,000 out of these 5,000 patients with again very powerful and differentiated efficacy profile for MPD. So a launch that we're incredibly excited about for all the right reasons, and that is not just around the corner.

我們對所見所聞感到非常興奮。我們估計光在美國就有大約 5,000 名患者，美國以外有 8,000 名患者。我想再次指出，由於我們研究的患者範圍很廣，包括青少年、C3G 以及移植前和移植後。我們最終可能只會爭奪這 5,000 名患者中的 1,500 到 2,000 名，而這些患者的 MPD 療效特徵同樣非常強大且具有差異化。因此，我們出於各種正當理由對這款產品的發布感到無比興奮，而且這項產品並非指日可待。

Tim, maybe you want to briefly speak to.

提姆，也許你想簡單談談。

Yes, sure. So if you look at the decrease in revenue, there was probably about 1/3 of that would be inventory and pricing dynamics. And the other 2/3 would really just be sort of a small decrease in demand over time versus last year. We've seen towards the a leveling off of that change. So we've seen actually incredibly good compliance vis-a-vis switches to our competitor product.

是的，當然。因此，如果你看一下收入的減少，其中大約有三分之一可能是庫存和定價動態造成的。而其餘 2/3 實際上只是需求量與去年同期相比隨著時間的推移略有下降。我們已經看到這種變化趨於平穩。因此，與我們的競爭對手的產品相比，我們實際上看到了非常好的合規性。

in the first quarter. I don't know, David, do you want to talk a little bit about that?

在第一季。我不知道，大衛，你想談談這個嗎？

I think that touched on, but we're seeing the -- what we do see is we see patients that will go to the oral Factor B product, but a number of times, we've seen them come back as a result of efficacy and the safety profile that we've presented with EMPAVELI.

我認為這已經觸及問題所在，但我們確實看到，有些患者會選擇口服因子 B 產品，但很多時候，由於 EMPAVELI 的功效和安全性，我們又回來了。

Derek Akhila, Wells Fargo.

富國銀行的德里克‧阿基拉 (Derek Akhila)。

This is on for Derek. A quick one from us. Can you share some updated thoughts on your cash runway given first quarter sales came in a bit lower than expected? And just discuss the puts and pulls as you move towards profitability?

這是德瑞克的勝利。我們快速說一下。鑑於第一季的銷售額略低於預期，您能否分享一些有關現金流的最新想法？在您實現盈利的過程中，您只討論利弊嗎？

Thank you very much. So we're not changing our guidance on cash runway and profitability. As we stated before. We continue to expect that our 2025 operating expenses will remain in line -- and obviously, the only impact we've seen here from a revenue perspective is some transient inventory dynamics and a little bit of an impact related to the switching to samples.

非常感謝。因此，我們不會改變對現金流和獲利能力的指導。正如我們之前所說的。我們仍然預計 2025 年的營運費用將保持不變——顯然，從收入角度來看，我們看到的唯一影響是一些暫時的庫存動態以及與轉換到樣品相關的一點影響。

But as we look forward, we expect the C3G -- the launch of C3G, which is a target for Q3 to meaningfully contribute to our top line. So we're maintaining our guidance as discussed.

但展望未來，我們預期 C3G 的推出，即第三季的目標，將為我們的營收做出有意義的貢獻。因此，我們將維持討論過的指導方針。

Graig Suvannavejh, Mizuho Securities.

Graig Suvannavejh，瑞穗證券。

I just wanted to return to SYFOVRE and the growth dynamics there. Could you just, for us paint a picture of where we are today in terms of prescribing of say for and perhaps just the complement inhibitor class. Should we expect that the growth outlook is more of a slow and steady grind? Or -- do you think that there is still a possibility for some sort of inflection -- some meaningful inflection as we think about the total commercial potential of not only CypoRy, but the class overall

我只是想回到 SYFOVRE 和那裡的成長動力。您能否為我們描述一下我們目前在處方補體抑制劑類藥物的現況？我們是否應該預期成長前景將更加緩慢而穩定？或者——您是否認為，當我們考慮不僅是 CypoRy 的整體商業潛力，而且是整個類別的整體商業潛力時，仍然有可能出現某種轉變——某種有意義的轉變

So thank you for that question, Greg. So I will -- look, this is a steady growth that again takes them to adopt, as Carolyn mentioned earlier, we have -- in addition to the work that David is doing that he spoke to in terms of bringing physicians along with the journey.

謝謝你的提問，格雷格。所以我會 — — 你看，這是一個穩定的增長，再次需要他們去適應，正如卡羅琳之前提到的，除了大衛正在做的工作之外，我們還有，他談到讓醫生參與到這一旅程中來。

There are a couple of things that will believe further acceleration points One notable 1 is the AI tools that we are working on and that are in development. What is important there is that we believe that we have the tools available to allow a physician and a patient to see the drug work for them. both on protecting retinal tissue as well as the impact that it can have on the visual function of the patient. That is something that is very exciting, will create further acceleration within this space. Caroline can maybe briefly expand on this because there is a present for this.

有幾件事相信會進一步加速點。其中值得注意的是我們正在研究和開發中的人工智慧工具。重要的是，我們相信我們擁有可用的工具，可以讓醫生和患者看到藥物對他們的作用，既可以保護視網膜組織，也可以對患者的視覺功能產生影響。這是非常令人興奮的事情，將進一步加速這一領域的發展。卡洛琳可以簡單闡述這一點，因為這是一份禮物。

Yes. Thank you, Cedric. So to highlight we have actually the largest data set of an approved product for the longest time period with favorable dosing. And we have so much experience from the anti-VEGF era, but we're able to pull out data-driven tools for physicians they are able to use that to really understand the disease and access their patients.

是的。謝謝你，塞德里克。因此，需要強調的是，我們實際上擁有經批准的產品在最長時間內具有最佳劑量的最大數據集。我們在抗 VEGF 時代擁有豐富的經驗，但我們能夠為醫生提供數據驅動的工具，讓他們能夠利用這些工具真正了解疾病並接觸到患者。

So I think that, that is something that's been missing at GA, and we're really at the forefront of being able to hold meaningful tools and algorithms for physicians and for patients. So people can understand we have data coming up who responds best to SYFOVRE, what's the patient experience and functional improvements for patients and all of that will increase the market for our patients.

所以我認為這是 GA 所缺少的東西，我們確實處於為醫生和患者提供有意義的工具和演算法的前沿。因此人們可以了解到，我們即將獲得數據，了解誰對 SYFOVRE 的反應最好，患者的體驗如何以及患者的功能改善如何，所有這些都將增加我們患者的市場。

Lisa Walter, RBC.

麗莎·沃爾特（RBC）。

Great. Maybe just one on the broader kidney space. We recently saw some IgAN data from Arrowhead with their C3 SiRNA -- and their early results looked on par with what aphalt has shown in IGAM. I'm just curious, would you consider also exploring your and other kidney indications.

偉大的。也許只是更廣泛的腎臟空間中的一個。我們最近看到了 Arrowhead 使用其 C3 SiRNA 的一些 IgAN 數據——其早期結果與 aphalt 在 IGAM 中顯示的結果相當。我只是好奇，您是否考慮也探索您的和其他腎臟適應症。

Thank you so much, Lisa. So we -- in the past couple of quarters, we've spoken about this. The efficacy that Bavette showed in C3G and IC-MPGN is absolutely remarkable as we go the trifecta, right, as you heard in our remarks earlier. What is really exciting here is that -- we did a thorough analysis. We have perfect or near perfect, we believe engagement of C3 and the kidney.

非常感謝，麗莎。因此，在過去的幾個季度中，我們已經討論過這個問題。正如您在我們之前的評論中聽到的那樣，Bavette 在 C3G 和 IC-MPGN 中表現出的療效絕對是顯著的，因為我們取得了三連勝。真正令人興奮的是──我們進行了徹底的分析。我們相信 C3 與腎臟的結合是完美的或近乎完美的。

We had to find where these which next indication to decide we could be exploring. After that, the analysis, we just said the 2 Phase III clinical trials, 1 graft function, 1 in focus segment of glomerulosclerosis gain is not 1 of those indications, but those are the 2 next ones where we believe we can make a meaningful difference in the kit.

我們必須找到這些跡象，以決定我們接下來可以進行探索的位置。之後，我們進行了分析，剛才我們說了 2 項 III 期臨床試驗、1 項移植功能試驗、1 項針對腎小球硬化症增益的重點研究，這些並不是這些適應症之一，但我們相信接下來的 2 項試驗可以在試劑盒中帶來有意義的改變。

Great. And maybe just 1 last 1 on SYFOVRE. I can't help it. I'm just wondering if you can give us any more color on the ex U.S. plans.

偉大的。也許 SYFOVRE 上只有最後一個。我沒辦法。我只是想知道您是否可以提供更多關於美國以外計劃的詳細資訊。

For instance, how is the launch progressing in Australia? And how has conversations with regulators been progressing in Canada, U.K. and Switzerland. Any color here would be helpful.

例如，在澳洲的發布進展如何？與加拿大、英國和瑞士監管機構的對話進展如何？這裡的任何顏色都會有幫助。

Thank you so much for that question. So in Australia, it's a little bit early, but the enthusiasm there about the retina community is meaningful and it's palpable. As it relates to other regions around the world, we continue to do the work -- we believe that the data, as it continues to grow.

非常感謝您提出這個問題。因此在澳大利亞，這還為時過早，但那裡對視網膜社區的熱情是有意義的，而且是顯而易見的。由於它與世界其他地區相關，我們將繼續進行這項工作——我們相信數據會不斷增長。

Remember, we have the GALE extension study for the 8-month data available to us now. It is undeniable what the benefit is that if we can provide to these patients that is something that we will continue to work on with regulators and then patients can end the best access globally for this product.

請記住，我們現在有 8 個月的 GALE 擴展研究數據可供使用。不可否認的是，如果我們能夠為這些患者提供這種藥物，我們將繼續與監管機構合作，然後患者就可以在全球範圍內獲得該產品的最佳治療。

And this concludes our Q&A session for today. I will turn it back to Cedric Francois for closing remarks.

今天的問答環節到此結束。我將把發言交還給塞德里克·弗朗索瓦 (Cedric Francois) 作最後發言。

Thank you so much, and thank you again, everybody, for joining us this morning. It's been a special quarter for us. Of course, in spite of what we saw in terms of revenue based on the dynamics, we see that continued growth in a market that has just started to grow and we believe we can make a huge difference for patients with SYFOVRE. Also with EMPAVELI just 3 months away from the launch and we look forward to speaking about that and the other elements of the company with you today and ends to come. Thank you so much.

非常感謝，再次感謝大家今天早上加入我們。對我們來說這是一個特別的季度。當然，儘管我們從動態角度看到了收入方面的成長，但我們看到剛開始成長的市場仍在持續成長，我們相信我們可以為 SYFOVRE 患者帶來巨大的改變。距離 EMPAVELI 上市僅剩 3 個月的時間，我們期待在今天以及未來與您討論 EMPAVELI 上市事宜以及公司的其他事宜。太感謝了。

And thank you all for participating in today's conference. You may now disconnect.

感謝大家參加今天的會議。您現在可以斷開連線。