Apellis Pharmaceuticals Inc (APLS) 2024 Q3 法說會逐字稿

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the Apellis Pharmaceuticals third quarter 2024 earnings conference call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to turn the call over to Meredith Kaya, Senior Vice President, Investor Relations & Strategic Finance. Please go ahead.

早安，女士們先生們。感謝您的耐心等待，歡迎參加 Apellis Pharmaceuticals 2024 年第三季財報電話會議。（操作員指示）請注意，今天的會議正在錄製中。我現在想將電話轉給投資者關係和策略財務高級副總裁 Meredith Kaya。請繼續。

Good morning, and thank you for joining us to discuss Apellis' third quarter 2024 financial results. With me on the call are Co-Founder and Chief Executive Officer, Dr. Cedric Francois; Chief Operating Officer, Adam Townsend; Chief Medical Officer, Dr. Caroline Baumal; and Chief Financial Officer, Tim Sullivan.

早安，感謝您與我們一起討論 Apellis 的 2024 年第三季財務業績。與我一起參加電話會議的是共同創辦人兼執行長 Cedric Francois 博士；營運長亞當湯森；首席醫療官 Caroline Baumal 博士；和首席財務官蒂姆·沙利文。

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陳述。這些陳述存在一定的風險和不確定性，實際結果可能有重大差異。我鼓勵您查閱我們向 SEC 提交的文件中討論的風險因素，以了解更多詳細資訊。

Now I'll turn the call over to Cedric.

現在我將把電話轉給塞德里克。

Thank you, Meredith, and thank you all for joining us this morning. Over the past few months, we have made meaningful progress towards our long-term goals, reaching key milestones such as generating continued growth in vial demand for SYFOVRE and presenting the groundbreaking Phase III VALIANT results with EMPAVELI C3G and IC-MPGN. These data underscore the power of C3 and reinforce our belief that targeting C3 is the optimal way to treat complement-mediated diseases.

謝謝梅雷迪思，也謝謝大家今天早上加入我們。在過去的幾個月裡，我們在實現長期目標方面取得了有意義的進展，達到了關鍵里程碑，例如使SYFOVRE 的小瓶需求持續增長，並透過EMPAVELI C3G 和IC-MPGN 展示了突破性的III 期VALIANT 結果。這些數據強調了 C3 的力量，並強化了我們的信念：標靶 C3 是治療補體介導疾病的最佳方法。

During the third quarter, commercial vial demand for SYFOVRE grew by 7% quarter-over-quarter and SYFOVRE maintained its market leadership with 84,500 commercial vials shipped to physicians.

第三季度，SYFOVRE 商業小瓶需求較上季成長 7%，SYFOVRE 保持其市場領先地位，向醫生運送了 84,500 個商業小瓶。

Third quarter SYFOVRE net product revenue of $152 million were more than double the same period last year. However, we recognized that revenue fell short of expectations, declining by 1.7% relative to the last quarter. This was partially due to higher gross to net adjustments, which Adam and Tim will speak to shortly. Importantly, we expect gross to nets to be stable going forward with more modest quarterly adjustments typical of a buy-and-bill model.

第三季SYFOVRE產品淨收入為1.52億美元，是去年同期的兩倍多。然而，我們認識到收入未達到預期，較上季下降 1.7%。這部分是由於毛淨調整的增加，亞當和提姆很快就會談到這一點。重要的是，我們預計未來毛淨值將保持穩定，季度調整將更加溫和，這是典型的購買和帳單模式。

Also affecting our performance this quarter was an overall slowing within the GA market. Total vial demand did grow quarter-over-quarter, but at a slower pace than in previous quarters. Market growth is now being driven by the next group of retina specialists who often need more time to appreciate the benefit/risk profile of complement treatments, and therefore, take longer to decide to treat their GA patients.

影響我們本季業績的另一個因素是通用航空市場的整體放緩。小瓶總需求確實季增，但成長速度低於前幾個季度。市場成長目前由下一批視網膜專家推動，他們通常需要更多時間來了解補體治療的益處/風險狀況，因此需要更長的時間來決定治療 GA 患者。

To support meaningful growth going forward, we need to continue building awareness of SYFOVRE's strong clinical profile. We have launched several key initiatives aimed at increasing our share of new patient starts, strengthening our market leadership and accelerating growth in the overall GA markets.

為了支持未來有意義的成長，我們需要繼續提高對 SYFOVRE 強大臨床特徵的認識。我們推出了幾項關鍵舉措，旨在增加新患者啟動的份額、加強我們的市場領導地位並加速整個 GA 市場的成長。

Early signs suggest that these efforts are delivering positive results, but their impact on the GA market and SYFOVRE demand will take time. Considering this, we remain conservative in our near-term expectations for growth, anticipating low single-digit percentage vial growth for the remainder of 2024 with flat to modest net revenue growth in the fourth quarter.

早期跡象表明這些努力正在取得積極成果，但它們對 GA 市場和 SYFOVRE 需求的影響需要時間。考慮到這一點，我們對近期成長預期保持保守，預計 2024 年剩餘時間內小瓶裝成長率將保持在個位數低水平，第四季度淨收入成長將持平至溫和。

We plan to provide further insight into the GA market dynamics and our growth expectations for 2025 in the coming months as we gain visibility into the impact of our new commercial initiatives. It is important to remember that we are still in the early stages of the launch. We estimate that only about half of all GA patients are diagnosed and seen by an eye care professional. And of those, an estimated 15% are currently being treated.

隨著我們了解新商業計劃的影響，我們計劃在未來幾個月內進一步深入了解 GA 市場動態以及我們對 2025 年的成長預期。重要的是要記住，我們仍處於發布的早期階段。我們估計，只有大約一半的 GA 患者得到眼科護理專業人員的診斷和治療。其中，估計有 15% 目前正在接受治療。

GA patients are on an irreversible path to blindness and SYFOVRE has a significant impact on slowing disease progression and potentially preserving patients' vision for longer. We see tremendous opportunity over the long term, but expect the sales ramp to be more ratable going forward. Importantly, we continue to believe SYFOVRE remains on track to becoming a blockbuster drug.

GA 患者正處於不可逆轉的失明之路，而 SYFOVRE 對減緩疾病進展並有可能更長時間地保留患者視力具有重大影響。從長遠來看，我們看到了巨大的機遇，但預計未來的銷售成長將更加可觀。重要的是，我們仍然相信 SYFOVRE 仍有望成為一種重磅藥物。

Quickly touching on Europe. We were disappointed with the negative CHMP opinion despite multiple analyses showing that treatment with SYFOVRE will preserve vital function. We do not have plans to pursue EU approval further at this time.

快速觸及歐洲。儘管多項分析表明 SYFOVRE 治療將保留重要功能，但我們對 CHMP 的負面意見感到失望。目前我們沒有進一步尋求歐盟批准的計劃。

And then moving to EMPAVELI. We were extremely pleased to share the full results from the Phase III VALIANT study in C3G and primary IC-MPGN at Kidney Week last month. I will let Caroline discuss these results further, but we believe EMPAVELI has the potential to become a best-in-class treatment for these rare kidney diseases, redefining the current treatment paradigm for patients with C3G and IC-MPGN.

然後前往 EMPAVELI。我們非常高興在上個月的腎臟週上分享 C3G 和初級 IC-MPGN 的 III 期 VALIANT 研究的完整結果。我會讓 Caroline 進一步討論這些結果，但我們相信 EMPAVELI 有潛力成為這些罕見腎臟疾病的最佳治療方法，重新定義目前 C3G 和 IC-MPGN 患者的治療模式。

At Apellis, we have spent the last two decades investigating C3 as a therapeutic target because we believe in the significant benefit of targeting C3 as compared to other targets within complement. These positive VALIANT results suggest, once again, that Apellis' C3-targeted therapies are particularly effective across multiple therapeutic areas, now including PNH, geographic atrophy and C3G and IC-MPGN.

在 Apellis，我們花了二十年的時間研究 C3 作為治療靶點，因為我們相信與補體內的其他標靶相比，標靶 C3 具有顯著的益處。這些積極的 VALIANT 結果再次表明 Apellis 的 C3 標靶療法在多個治療領域特別有效，目前包括 PNH、地理萎縮以及 C3G 和 IC-MPGN。

We received feedback from the FDA last week that our submission proposal has been accepted, which means that we remain on track to file our supplemental NDA early next year in both C3G and IC-MPGN based on our positive 6-month data.

上週我們收到 FDA 的回饋，表明我們的提交提案已被接受，這意味著我們仍有望根據 6 個月的積極數據於明年初在 C3G 和 IC-MPGN 中提交補充 NDA。

Importantly, the FDA did not require us to file with the full 52-week data. Our ex US partner, Sobi, expects to file a regulatory submission in the EU in early 2025, followed by a submission with the Japanese health authorities later in 2025. The VALIANT data also unlocked additional opportunities within nephrology that we are evaluating and plans to provide detail on soon.

重要的是，FDA 沒有要求我們提交完整的 52 週數據。我們的前美國合作夥伴 Sobi 預計於 2025 年初向歐盟提交監管申請，隨後於 2025 年稍後向日本衛生當局提交申請。VALIANT 數據還釋放了腎臟病學領域的更多機會，我們正在評估這些機會，並計劃很快提供詳細資訊。

On the commercial front, EMPAVELI generated $24.6 million in US product revenue in PNH in the third quarter, up 3% as compared to the same period last year. The 97% compliance rate supports the substantial benefit that these patients are receiving.

商業方面，EMPAVELI第三季在PNH的美國產品營收為2,460萬美元，比去年同期成長3%。97% 的依從率支持了這些患者正在獲得的實質益處。

In closing, our strong fundamentals position us well for the future. Apellis has two commercial products, each with blockbuster potential, which are already making a meaningful difference in patients' lives. Our emerging pipeline holds exciting products, and we look forward to sharing more on this soon. We are on a clear path to profitability and continue to believe we can independently fund our core business.

最後，我們強大的基本面為我們的未來奠定了良好的基礎。Apellis 擁有兩種商業產品，每種產品都具有巨大的潛力，已經對患者的生活產生了有意義的改變。我們的新興產品線擁有令人興奮的產品，我們期待盡快分享更多相關內容。我們正走在一條清晰的獲利之路上，並繼續相信我們可以獨立為我們的核心業務提供資金。

And with that, I will now turn it over to Adam to discuss our commercial activities.

現在，我將把它交給 Adam 來討論我們的商業活動。

Thanks, Cedric, and good morning, everyone. I will begin with SYFOVRE. In the third quarter, we delivered approximately 84,500 commercial doses, a 7% increase compared to Q2 and approximately 4,000 samples of SYFOVRE. The growth in demand seen during the quarter reaffirm SYFOVRE's leadership in the market. SYFOVRE closed the third quarter with approximately 65% market share as defined by injections and approaching half of new patient starts. As of September, more than 2,200 sites of care have awarded SYFOVRE.

謝謝，塞德里克，大家早安。我將從 SYFOVRE 開始。第三季度，我們交付了約 84,500 劑商業劑量，與第二季度相比增加了 7%，並交付了約 4,000 個 SYFOVRE 樣品。本季需求的成長再次證實了 SYFOVRE 在市場中的領導地位。SYFOVRE 在第三季結束時佔了約 65% 的市場份額（以注射量計算），並且佔新患者的近一半。截至 9 月，已有 2,200 多個護理機構獲得了 SYFOVRE 獎。

As Cedric mentioned, the increase in demand was offset by adjustments to our gross to net, including contracting, that affected overall net revenue. As a reminder, contracting with physician practices is common within the buy-and-bill space.

正如塞德里克所提到的，需求的成長被我們的總淨收入調整（包括合約）所抵消，這影響了整體淨收入。提醒一下，與醫生診所簽訂合約在購買和帳單領域很常見。

At the end of 2023, we made strategic contracting decisions to remain competitive that impacted SYFOVRE's average sales price or ASP reimbursement in the third quarter of 2024. We also recorded higher rebates this quarter due to some incremental contracting decisions that took effect on July 1.

2023 年底，我們做出了策略承包決策以保持競爭力，這影響了 SYFOVRE 在 2024 年第三季的平均銷售價格或 ASP 報銷。由於 7 月 1 日生效的一些增量合約決定，我們本季也獲得了更高的回扣。

While this quarter was particularly impacted, to be clear, we have not chased large rebates or deep discounts nor do we intend to in the future. Our strategy has always been to maximize access to SYFOVRE for patients while preserving long-term economics. We recognize the importance of staying competitive and have balanced these economics with the efficacy that SYFOVRE offers.

雖然本季受到的影響尤其嚴重，但需要明確的是，我們沒有追求大額回扣或大幅折扣，將來也不打算這樣做。我們的策略始終是最大限度地為患者提供 SYFOVRE，同時保持長期經濟效益。我們認識到保持競爭力的重要性，並平衡了這些經濟效益與 SYFOVRE 提供的功效。

Turning back to demand. We are encouraged by the continued demand growth for SYFOVRE, but we know there's more work to do to sustain this growth moving forward. To that end, we've launched several initiatives as part of Phase 2 of our commercial strategy to help shift the dialogue with ECPs towards SYFOVRE's robust efficacy profile including its increasing effects over time up to 42% in non-subfoveal patients, multiple analyses demonstrating preservation of visual function and well-documented safety.

回到需求。我們對 SYFOVRE 需求的持續成長感到鼓舞，但我們知道，要維持這種成長，還有更多工作要做。為此，我們啟動了多項舉措，作為我們商業策略第二階段的一部分，以幫助將與ECP 的對話轉向SYFOVRE 強大的療效特徵，包括隨著時間的推移，其對非中心凹下患者的療效增加高達42%，多項分析顯示保留視覺功能和有據可查的安全性。

Key initiatives include leveraging medical congresses and other key forums to reinforce SYFOVRE's unique benefits, actively engaging with younger retina specialists who tend to treat a higher share of new patients, expanding our engagement with non-injecting ECPs such as optometrists and general ophthalmologists so that patients with GA seek treatment with a specialist, generating new clinical data and real-world evidence to further reinforce SYFOVRE's clinical profile.

主要措施包括利用醫學大會和其他重要論壇來強化 SYFOVRE 的獨特優勢、積極與傾向於治療更多新患者的年輕視網膜專家合作、擴大與驗光師和普通眼科醫生等非注射 ECP 的合作，以便患者能夠與GA 一起尋求專家治療，產生新的臨床數據和真實世界證據，以進一步強化SYFOVRE 的臨床特徵。

We introduced the new injection needle, making the user experience even easier by reducing injection force. And we continue to educate payers on the strong value proposition for SYFOVRE. We are pleased to already see some early indications of positive momentum.

我們推出了新的注射針，透過減少注射力使用戶體驗更加輕鬆。我們繼續向付款人宣傳 SYFOVRE 強大的價值主張。我們很高興看到一些積極勢頭的早期跡象。

For example, after seeing a slight decline in new patient share at the start of Q3, SYFOVRE rebounded in the last half of the quarter, closing the quarter approaching 50%. Additionally, market research shows the efficacy messages are resonating. Surveyed ECPs recall SYFOVRE's efficacy as the leading discussion topic from their last Apellis interaction, up from 46% in April to 73% in September.

例如，在第三季初新患者份額略有下降後，SYFOVRE 在本季後半段出現反彈，季度結束時接近 50%。此外，市場研究表明功效訊息引起了共鳴。受調查的 ECP 回憶起 SYFOVRE 的功效是他們上次 Apellis 互動中的主要討論主題，從 4 月份的 46% 上升到 9 月份的 73%。

And lastly, a large Medicare Advantage plan recently made SYFOVRE the only preferred product on their formulary effective January 1, 2025. This adds to the 2 large national PBMs that place SYFOVRE as the only preferred product on their commercial plans in July.

最後，一項大型 Medicare Advantage 計劃最近使 SYFOVRE 成為其處方集上唯一的首選產品，自 2025 年 1 月 1 日起生效。這使得 2 個大型國家 PBM 將 SYFOVRE 作為其 7 月份商業計劃中唯一的首選產品。

Looking ahead, we plan to launch Phase 2 of our branded DTC campaign soon, which brings back Henry Winkler. This campaign is intended to educate patients on SYFOVRE's profile, increasing patient awareness and driving SYFOVRE conversations with ECPs.

展望未來，我們計劃很快啟動品牌 DTC 活動的第二階段，亨利溫克勒 (Henry Winkler) 將會回歸。該活動旨在讓患者了解 SYFOVRE 的概況，提高患者意識並推動 SYFOVRE 與 ECP 的對話。

SYFOVRE's market share has been stable at roughly 65% since September. This, combined with the uptick in new patient share in recent weeks, suggest that our initiatives are starting to have an impact. While we are encouraged by the positive momentum, it will still take time for these to gain traction, which is why we must be prudent in our guidance for the remainder of 2024.

自9月以來，SYFOVRE的市佔率一直穩定在65%左右。再加上最近幾週新患者比例的上升，顯示我們的措施已開始產生影響。儘管我們對這一積極勢頭感到鼓舞，但這些措施仍需要時間才能獲得牽引力，這就是為什麼我們必須謹慎對待 2024 年剩餘時間的指導。

Market research shows that questions about safety continue to delay more meaningful discussions about the benefits of SYFOVRE and those benefits that are offered to patients. It can take at least six conversations with an ECP before the efficacy messages truly resonate.

市場研究表明，有關安全性的問題繼續推遲對 SYFOVRE 的益處以及為患者提供的益處進行更有意義的討論。在功效訊息真正引起共鳴之前，可能需要與 ECP 進行至少六次對話。

That said, our long-term outlook for SYFOVRE remains strong. We have only scratched the surface of SYFOVRE's market potential and there is a significant opportunity for further growth. We anticipate growth moving forward will be gradual, but with only two available therapies in a large category and no new competition expected for at least the next four years, we are confident SYFOVRE will remain the leading GA product in the US for many years to come.

儘管如此，我們對 SYFOVRE 的長期前景依然強勁。我們僅僅觸及了 SYFOVRE 市場潛力的冰山一角，還有進一步成長的重大機會。我們預計未來的成長將是漸進的，但由於一個大類別中只有兩種可用療法，並且預計至少在未來四年內不會有新的競爭，我們相信SYFOVRE 將在未來許多年中仍然是美國領先的GA 產品。

Beyond SYFOVRE, I'm excited about the opportunity for EMPAVELI to expand into C3G and IC-MPGN. We believe the commercial opportunity for these indications is significant. We estimate approximately 5,000 patients in the US, but also believe that these diseases are likely under diagnosed because there are no treatments currently available.

除了 SYFOVRE 之外，我對 EMPAVELI 有機會擴展到 C3G 和 IC-MPGN 領域感到很興奮。我們相信這些適應症的商業機會是巨大的。我們估計美國約有 5,000 名患者，但也認為這些疾病可能未被診斷出來，因為目前沒有可用的治療方法。

Feedback from physicians has been resoundingly positive that the severity of these diseases warrants use of the most efficacious treatment option available. Across the Board, nephrologist feedback is that EMPAVELI data are significantly differentiated from other compounds in development with the enthusiasm among physicians exceeding even our highest expectations. If approved, we believe we are in a strong position to capture a significant proportion of this market and generate meaningful growth for EMPAVELI.

醫生的回饋非常積極，顯示這些疾病的嚴重性需要使用最有效的治療方案。總體而言，腎臟病專家的回饋是 EMPAVELI 數據與其他正在開發的化合物顯著不同，醫生的熱情甚至超出了我們的最高預期。如果獲得批准，我們相信我們將處於有利地位，能夠佔領該​​市場的很大一部分，並為 EMPAVELI 帶來有意義的成長。

Now let me shift to EMPAVELI in PNH. In the third quarter, EMPAVELI generated approximately $24.6 million in US net product revenues. Compliance rate remained high at 97%, and the safety profile remains consistent with our previous updates.

現在讓我轉到 PNH 的 EMPAVELI。第三季度，EMPAVELI 在美國的產品淨收入約為 2,460 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 Caroline. Caroline?

現在，我將把電話轉給卡羅琳。卡洛琳？

Thanks, Adam, and good morning, everyone. As Adam mentioned, we are starting to see multiple instances of meaningful real-world presentations, reaffirming SYFOVRE's robust efficacy and we expect the first paper from a third-party on SYFOVRE to be published soon. These real-world data reinforce SYFOVRE's unprecedented effects, adding to the largest body of evidence supporting SYFOVRE treatment and allowing us to further strengthen our message around efficacy.

謝謝亞當，大家早安。正如 Adam 所提到的，我們開始看到多個有意義的現實世界演示實例，重申了 SYFOVRE 的強大功效，我們預計第三方關於 SYFOVRE 的第一篇論文很快就會發表。這些真實世界的數據強化了 SYFOVRE 前所未有的效果，增加了支持 SYFOVRE 治療的最大證據，並使我們能夠進一步強化有關療效的資訊。

Moving to EMPAVELI. The feedback on the full VALIANT data set that was presented at Kidney Week last month was remarkable. In these diseases, physicians are focused on three key markers of disease activity when evaluating a potential treatment. These are proteinuria, eGFR and C3c staining. As detailed in our full data set, pegcetacoplan showed positive effects on all three in just six months.

搬到恩帕韋利。上個月在腎臟週上發布的完整 VALIANT 數據集的反饋非常出色。在這些疾病中，醫生在評估潛在治療方法時重點關注疾病活動的三個關鍵標誌。這些是蛋白尿、eGFR 和 C3c 染色。正如我們完整資料集中所詳述的那樣，pegcetacoplan 在短短六個月內對這三者都顯示出了積極的效果。

This included a statistically significant 68% reduction in proteinuria with reductions observed as early as week four and effects that were consistent across all subgroups of patients regardless of disease type, age and transplant status. A stabilization of eGFR, a key measure of disease function. And a substantial reduction in C3c staining with over 70% of pegcetacoplan-treated patients having achieved 0 C3c staining intensity, indicating complete clearance of C3c deposits.

這包括統計上顯著的蛋白尿減少 68%，早在第四週就觀察到蛋白尿減少，無論疾病類型、年齡和移植狀態如何，所有患者亞群的效果都是一致的。eGFR 的穩定性是疾病功能的關鍵指標。C3c 染色顯著減少，超過 70% 的接受 pegcetacoplan 治療的患者 C3c 染色強度達到 0，顯示 C3c 沉積物完全清除。

There are no approved treatments for C3G or IC-MPGN and the unmet need, given the severity of these diseases, is extremely high. The totality of the efficacy data from VALIANT shows that pegcetacoplan rapidly, significantly and consistently improved key outcomes for patients with C3G and IC-MPGN.

目前還沒有針對 C3G 或 IC-MPGN 的核准治療方法，鑑於這些疾病的嚴重性，未滿足的需求非常高。VALIANT 的整體療效數據表明，pegcetacoplan 快速、顯著且持續地改善了 C3G 和 IC-MPGN 患者的關鍵結局。

We are ecstatic about what the results mean for the patients, physicians, caregivers and everyone else within the C3G and IC-MPGN communities.

我們對結果對患者、醫生、護理人員以及 C3G 和 IC-MPGN 社區中的其他所有人的意義感到欣喜若狂。

Finally, we are continuing to advance our earlier-stage pipeline such as our C3 siRNA that is currently in Phase I development and our Beam collaboration. We are excited to share more details about our pipeline programs with you in the future.

最後，我們正在繼續推進我們的早期研發管線，例如目前處於 I 期開發的 C3 siRNA 以及我們的 Beam 合作。我們很高興將來與您分享有關我們管道計劃的更多詳細資訊。

I will now turn the call over to Tim for a review of the financials. Tim?

我現在將把電話轉給蒂姆，以審查財務狀況。提姆？

Thank you, Caroline. I will now provide an overview of our financials. Additional details are available in the press release that we issued earlier this morning. Total revenue for the third quarter of 2024 was approximately $197 million, including $152 million in SYFOVRE and $24.6 million in EMPAVELI US net product revenue. This compares with $110 million in total revenue in the third quarter of 2023.

謝謝你，卡洛琳。我現在將概述我們的財務狀況。更多詳細資訊請參閱我們今天早上早些時候發布的新聞稿。2024年第三季的總收入約為1.97億美元，其中SYFOVRE的1.52億美元和EMPAVELI US的產品淨收入為2,460萬美元。相比之下，2023 年第三季的總營收為 1.1 億美元。

Turning to the rest of the P&L. For the third quarter, cost of sales was $33.6 million. R&D expenses were $88.6 million. SG&A expenses were $122 million. And we reported a net loss of $57.4 million.

轉向損益表的其餘部分。第三季的銷售成本為 3,360 萬美元。研發開支為 8,860 萬美元。銷售及管理費用費用為 1.22 億美元。我們報告淨虧損 5740 萬美元。

Cash operating expenses, which excludes stock-based compensation and depreciation and amortization were approximately $180 million for the third quarter. We continue to expect total cash operating expenses in 2024, inclusive of R&D and SG&A expenses, to be less than our total cash expenses in 2023.

第三季現金營運支出（不包括股票薪酬以及折舊和攤提）約為 1.8 億美元。我們仍預期 2024 年的總現金營運支出（包括研發和銷售、一般管理費用）將低於 2023 年的總現金支出。

As Adam mentioned, there was an increase in SYFOVRE's gross to net percentage this quarter as compared to previous quarters. This is a result of two factors. The first was due to contract decisions resulting in higher discounts to physicians. The second was related to a true-up of certain fees from prior quarters included in gross to net in Q3.

正如 Adam 所提到的，與前幾季相比，本季 SYFOVRE 的毛淨百分比有所增加。這是兩個因素的結果。第一個是由於合約決定導致醫生獲得更高的折扣。第二個與第三季毛額和淨額中前幾季的某些費用的調整有關。

Looking ahead, we expect gross to net to continue to be impacted by ASP erosion and required contracting, but we expect that erosion to be modest and not at the rate we saw in the third quarter. We now expect gross to net through 2025 to be in the low to mid-20% range.

展望未來，我們預計總淨值將繼續受到平均售價侵蝕和所需合約的影響，但我們預計侵蝕程度將是溫和的，不會達到我們在第三季看到的速度。我們現在預計到 2025 年總淨值將在 20% 的低至中範圍內。

With $397 million in cash and cash equivalents as of September 30, we remain confident in our strong financial position. We expect our existing cash, combined with our future product sales to be sufficient to fund our core business to positive cash flow.

截至 9 月 30 日，我們擁有 3.97 億美元的現金和現金等價物，我們對強勁的財務狀況仍然充滿信心。我們預期現有現金加上未來的產品銷售足以為我們的核心業務提供正現金流。

I will now hand the call back over to Cedric for closing remarks. Cedric?

我現在將把電話轉回給塞德里克進行結束語。塞德里克？

Thank you, Ted. We are focused on building out the GA market and realizing the opportunity in front of us in C3G and IC-MPGN. With two potentially blockbuster commercial products, a pipeline of innovative programs in development and a strong financial position to support the business, we are confident in our ability to continue to create significant value for our patients and our shareholders.

謝謝你，泰德。我們專注於開拓 GA 市場並抓住 C3G 和 IC-MPGN 領域的機會。憑藉兩款潛在的重磅商業產品、一系列正在開發的創新項目以及支持業務的強大財務狀況，我們對繼續為患者和股東創造重大價值的能力充滿信心。

With that, we will now go over to the Q&A session.

接下來，我們將進入問答環節。

(Operator Instructions)

（操作員說明）

Jon Miller, Evercore.

喬恩‧米勒，《Evercore》。

Hi, guys. Thanks so much for taking the question. I would love to spend my one question talking about the evolution of market share in 3Q and beyond. Obviously, we all heard your competitor talking about increased market share in 3Q and their expectations for, well, in their mind, continuing dominance from here.

嗨，大家好。非常感謝您提出問題。我很想用一個問題來談談第三季及以後市場佔有率的演變。顯然，我們都聽到你的競爭對手談論第三季度市場份額的增加，以及他們對從這裡繼續佔據主導地位的期望。

So what are the pushes and pulls of you versus them on who's going to end up with the dominant market share? And to what extent do you think that the actions you're taking to drive patients into the retina physician practice out of those ophthalmology offices, to what extent are those going to deliver patients to you as opposed to the competitor?

那麼，你與他們相比，對誰最終會獲得主導市場份額的推動力和拉力是什麼？您認為您所採取的行動在多大程度上將患者從眼科診所轉移到視網膜醫生診所，在多大程度上將患者轉移給您而不是競爭對手？

Thank you, Jon. So look, as we've always said, the benefit of SYFOVRE lies in its differentiated efficacy profile, right? It is also the only drug that has shown increasing effects over time that has shown efficacy with every-other-month dosing both in foveal and subfoveal patients. That differentiated efficacy profile is really what stands out and what we will be building the market on now.

謝謝你，喬恩。那麼，就像我們一直說的那樣，SYFOVRE 的優勢在於其差異化的功效特徵，對吧？它也是唯一一種隨著時間的推移效果逐漸增強的藥物，每隔一個月給藥一次，對中心凹和中心凹下患者均顯示出療效。這種差異化的功效確實是最突出的，也是我們現在建立市場的基礎。

So Adam, I'll hand it over to you to maybe add a couple of thoughts.

Adam，我會把它交給你，也許你可以補充一些想法。

Yes. Thanks, Jon. So obviously, as we're heading into year 3 of the launch, we're now calculating market share based on injections versus based on patients. We actually believe this is similar to the way our competitor calculates market share. We think it's a really important metric and we believe that we are at a market share of 65%. Now if we were still to use our market share based on patients, as we have previously reported, that market share would be approximately 70%. Injection share incorporates factors such as dosing frequency, bilateral usage, compliance and active patients. That's why we think it's a really valuable metric.

是的。謝謝，喬恩。顯然，隨著我們進入上市的第三年，我們現在正在根據注射和患者來計算市場份額。我們實際上認為這與我們的競爭對手計算市場份額的方式類似。我們認為這是一個非常重要的指標，我們相信我們的市場佔有率為 65%。現在，如果我們仍然使用基於患者的市場份額，正如我們之前報導的那樣，市場份額將約為 70%。注射份額綜合了給藥頻率、雙邊使用、依從性和活躍患者等因素。這就是為什麼我們認為這是一個非常有價值的指標。

Now as per new patient starts, after seeing a slight decline in new patient starts at the start of Q3, SYFOVRE rebounded in the last half of the quarter, closing the quarter approaching 50%. The reason we believe is that this is an efficacy-driven market and we have the strongest efficacy profile, and we're executing our plan to bring new prescribers and young prescribers into the market.

現在，從新患者開工率來看，在第三季初新患者開工率略有下降之後，SYFOVRE 在本季後半段出現反彈，季度末成長接近 50%。我們相信這是一個功效驅動的市場，我們擁有最強的功效，我們正在執行我們的計劃，將新的處方者和年輕的處方者引入市場。

So does that answer your question?

那麼這回答了你的問題嗎？

Yes, that helps. Thank you very much. I'll hope back in the queue.

是的，這有幫助。非常感謝。我希望能回到隊列中。

Tazeen Ahmad, Bank of America.

塔津·艾哈邁德，美國銀行。

Hi, guys. Good morning. Thanks for taking my question. And maybe wanted to stay on topic with SYFOVRE. Your competitor has been wanting, it seems, to provide a lot of detail about the cadence of their launch, providing a first stab at guidance and then revising it at their last call upward. I know a question that investors had is when Apellis would feel comfortable providing guidance on sales.

嗨，大家好。早安.感謝您提出我的問題。也許還想繼續討論 SYFOVRE 的話題。您的競爭對手似乎一直希望提供有關其發布節奏的大量詳細信息，提供初步指導，然後在最後一次向上電話會議時進行修改。我知道投資者的一個問題是 Apellis 何時願意提供銷售指導。

And I think that's also tied to how people think you think the rate of growth of the market is going to be. I think there's some questions about the size of GA with the two products currently approved. So what are you feeling that you need comfort on in order to provide, let's say, full year sales guide on a go-forward basis? And how are you thinking that's going to be reflected about how you're thinking about the size of the overall opportunity? Thanks.

我認為這也與人們對市場成長率的看法有關。我認為目前批准的兩種產品的 GA 規模存在一些問題。那麼，您覺得您需要什麼安慰才能提供（比方說）未來的全年銷售指南？您認為這將如何反映您對整體機會大小的看法？謝謝。

Thank you, Tazeen. Look, we're considering providing guidance for next year and we haven't made a decision on that yet. A couple of things, we have these initiatives we've discussed and there are certain market dynamics that we think will settle out over time. We'd like to see how those evolve. And for the moment right now, we're focused on fortifying our position as the market leader and growing the GA market overall. But once I think we feel we have a little bit better understanding of that, I think we would feel comfortable giving some sort of guidance. But at this point, it's under consideration.

謝謝你，塔津。看，我們正在考慮為明年提供指導，但我們尚未就此做出決定。有幾件事，我們已經討論過這些舉措，我們認為某些市場動態會隨著時間的推移而解決。我們想看看這些是如何演變的。目前，我們的重點是鞏固我們作為市場領導者的地位並整體發展 GA 市場。但一旦我認為我們對此有了更好的理解，我想我們會很樂意提供某種指導。但目前正在考慮中。

Anupam Rama, JPMorgan.

阿努帕姆‧拉瑪，摩根大通。

Hey, guys. Thanks so much for taking the question. Do you think your sales team is sort of rightsized to get to that next tier of docs that you're talking about in terms of prescribing SYFOVRE and a complement inhibitor? And any trends we should think about in terms of sampling for that next tier of physicians relative to what you kind of disclosed in 3Q? Thanks so much.

嘿，夥計們。非常感謝您提出問題。您認為您的銷售團隊規模是否適當，能夠獲得您所談論的 SYFOVRE 和補體抑制劑處方方面的下一層文件？與您在第三季揭露的情況相比，我們應該考慮下一級醫生的抽樣趨勢？非常感謝。

Anupam, it's Adam. Thanks for your questions. So we analyze our sales team and our infrastructure on a regular basis based on our target audience. And at the moment, we believe that we have the right field force structure to execute and grow a depth and a breadth strategy across the market.

阿努潘，我是亞當。感謝您的提問。因此，我們根據目標受眾定期分析我們的銷售團隊和基礎設施。目前，我們相信我們擁有合適的現場人員結構來執行和發展整個市場的深度和廣度策略。

We have made a couple of new initiatives to drive more patients and patient referrals. So we are in the process of putting an ophthalmology field team in place to educate on geographic atrophy for non-injecting ophthalmologists to help refer patients to SYFOVRE usage. And we also have a digital virtual optometry team to also fuel more and more referrals to injecting retina physicians.

我們採取了一些新措施來推動更多患者和患者轉診。因此，我們正在組建一個眼科現場團隊，為非注射眼科醫生提供有關地理萎縮的教育，以幫助患者轉介使用 SYFOVRE。我們還有一個數位虛擬驗光團隊，也可以推動越來越多的視網膜注射醫師轉診。

As it comes to sampling, obviously, with our commercial vial demand growing at 7% and given that this is a buy-and-bill commercial model, we now have a J-code, we have well-established payer coverage and over 2,200 sites of care, we believe that sampling has less significant role at the moment, but we still believe that samples will make up approximately 5% of SYFOVRE's total vial demand moving forward. You would expect that new prescribers will use samples as part of this market as they get more and more experience of SYFOVRE.

顯然，在取樣方面，我們的商業小瓶需求增長了 7%，並且考慮到這是一種購買後計費的商業模式，我們現在擁有 J 代碼、完善的付款人覆蓋範圍和 2,200 多個站點就護理而言，我們認為目前採樣的效果較不重要，但我們仍然相信，未來樣品將佔SYFOVRE 總小瓶需求的約5%。您可能會期望新的處方者會使用樣品作為這個市場的一部分，因為他們獲得了越來越多的 SYFOVRE 經驗。

Salveen Richter, Goldman Sachs.

薩爾文·里克特，高盛。

Thank you. Good morning. You noted that market growth is now being driven by the next group of retinal specialists. Could you just elaborate on who these specialists are and how large that group is? And if I could just also just go back to this flat to modest revenue growth in 4Q. Can you just help us understand what this accounts for in terms of gross to net?

謝謝。早安.您指出，市場成長現在是由下一批視網膜專家推動的。您能否詳細說明一下這些專家是誰以及該群體有多大？如果我也能回到這個持平的狀態，第四季的營收將適度成長。您能幫我們了解一下這在毛淨額中佔什麼比例嗎？

Thank you so much, Salveen. I will answer the first part of the question and then hand it over to Tim. So I think the retina community, and I think this is not just typical to the retina community but any type of launch, you have the initial wave where you have patients that have been waiting on the sidelines for something to be approved with retina doctors that are enthusiastic to the first movers.

非常感謝你，薩爾文。我將回答問題的第一部分，然後交給蒂姆。所以我認為視網膜社區，我認為這不僅是視網膜社區的典型現象，而且是任何類型的發布，在最初的一波浪潮中，患者一直在場邊等待視網膜醫生批准的東西，對先行者充滿熱情。

And then you have a whole swath of the next wave of physicians as well as patients in a disease that is slowly progressing, that kind of wait for the dust to settle of that first wave to then engage and slow down this devastating disease. So that's really where we currently are and what we are seeing in the marketplace. Caroline, I don't know if you want to add something to this?

然後，下一波的醫生和患者都患有一種正在緩慢進展的疾病，等待第一波的塵埃落定，然後參與並減緩這種毀滅性的疾病。這就是我們目前的處境以及我們在市場上看到的情況。卡洛琳，我不知道你是否想補充一些東西？

Sure. Thank you. I think that many trainees and younger retina doctors also have only been in practice for a limited time, so have maybe not seen the full effects of geographic accuracy on their patients. But they're very, very motivated to learn about geographic atrophy and how to treat these patients. So we really would like to make sure that we don't forget any of these new, young trainees and with more and more physicians training in retina that they have available to SYFOVRE.

當然。謝謝。我認為許多實習生和年輕的視網膜醫生也只實習了有限的時間，因此可能沒有看到地理準確性對患者的全面影響。但他們非常非常有動力去了解地理萎縮以及如何治療這些患者。因此，我們真的希望確保我們不會忘記這些新的年輕學員，以及越來越多的醫生接受 SYFOVRE 的視網膜訓練。

In terms of the guidance, that incorporates our gross to net that I mentioned in the prepared remarks, which was going forward through 2025, we believe, that gross to net will be in the low to mid 20s. Obviously, this quarter, we had a relatively large gross to net jump. That's a function of certain launch dynamics that all came together in this third quarter. So we don't expect anything remotely like this going forward and gross to net to evolve in a more in a modest sense as ASP sort of steadily erodes as we discussed.

就指導而言，這包括我在準備好的發言中提到的我們的毛淨值，我們相信，毛淨值將在 20 多歲左右，這一目標將持續到 2025 年。顯然，本季我們的毛淨值增幅較大。這是第三季某些發布動態的結果。因此，正如我們所討論的那樣，隨著 ASP 的穩定下降，我們預計未來不會有任何類似的事情發生，總淨值會以更溫和的方式發展。

Yigal Nochomovitz, Citigroup.

伊格爾·諾霍莫維茨，花旗集團。

Yeah, hi, guys. Thank you. So for my one question, I guess I'll ask a two part question. Could you just provide a little more clarity on this impact to the ASP? It sounds like there was something related to maybe a discount trigger in the contract related to order volume that may have just all lined up in the third quarter, if you could clarify that.

是的，嗨，夥計們。謝謝。因此，對於我的一個問題，我想我會問一個由兩部分組成的問題。您能否更清楚地說明一下這種情況對 ASP 的影響？如果你能澄清一下的話，聽起來好像合約中可能有一些與訂單量有關的折扣觸發因素，這些訂單量可能在第三季就全部排好了。

And then regarding the duration and persistence of therapy, I'm curious if you've collected any data, Adam, in terms of the percent of patients that are staying on the therapy and then the percent that may be taking a break or don't return on schedule? Thank you.

然後關於治療的持續時間和持續性，亞當，我很好奇你是否收集了任何數據，包括繼續接受治療的患者百分比，以及可能休息或不接受治療的患者百分比。謝謝。

So sure. Thanks, Yigal. I will start with the gross to net part of your question. So the impact in the third quarter was really a result of three things. I know we mentioned two in the prepared remarks, but I'll dig in and divide this first one into two parts and this ultimately sort of created the perfect storm for just this quarter.

非常確定。謝謝，伊格爾。我將從你的問題的總體到淨值部分開始。因此，第三季的影響實際上是三件事造成的。我知道我們在準備好的評論中提到了兩個部分，但我將深入研究並將第一個部分分為兩個部分，最終為本季創造了完美的風暴。

The first one, which is, again, these two parts is the strategic contracting decisions that we actually made in late 2023 and that resulted in a lower ASP starting in Q3, okay? Beyond that, we had certain rebates provided as a result of incremental contracts within the third quarter. And then the final piece, which is not insignificant, was a true-up of certain fees and expenses from prior quarters. So as I said, we now expect gross to net through 2025 to be in the low to mid-20% range.

第一個，也就是這兩部分，是我們在 2023 年底實際做出的策略承包決策，這導致從第三季開始較低的平均售價，好嗎？除此之外，我們也因第三季增量合約而提供了一定的回扣。最後一部分並非無關緊要，它是對前幾季的某些費用和支出的調整。正如我所說，我們現在預計到 2025 年總淨值將在 20% 的低至中範圍內。

Hey, Yigal, it's Adam. You also asked a question on discons. So obviously, at the moment, we're happy with the feedback from physicians on patient adherence. We're seeing persistence and discontinuation rates similar to what is seen with the anti-VEGFs in wet AMD.

嘿，伊格爾，我是亞當。你還問了一個關於discons的問題。顯然，目前我們對醫生關於病人依從性的回饋感到滿意。我們看到的持續性和停藥率與濕性 AMD 中抗 VEGF 藥物的情況相似。

A key driver of compliance is patient motivation. These patients are really committed to staying on drug to preserve their vision. Every-other-month dosing provides meaningful flexibility to those patients, and we believe that also drives strong compliance with the efficacy you also see with every-other-month dosing.

依從性的關鍵驅動因素是患者的積極性。這些患者確實致力於繼續服用藥物以保持視力。每隔一個月給藥為這些患者提供了有意義的靈活性，我們相信這也可以提高您對每隔一個月給藥的療效的強烈依從性。

Thank you.

謝謝。

Steve Seedhouse, Raymond James.

史蒂夫席德豪斯，雷蒙德詹姆斯。

Hi. Thank you. This is Nick on for Steve. Just a quick one for us. Are you able to comment on which renal indications you like for testing EMPAVELI next? Or do you have a time line set for when you'd articulate further clinical development in kidney? Thank you.

你好。謝謝。這是尼克替史蒂夫發言。對我們來說只是一個快速的。您能否評論一下接下來您希望測試 EMPAVELI 的哪些腎臟適應症？或者您設定了闡明腎臟進一步臨床開發的時間表？謝謝。

Thank you so much for that question. So not yet is the short answer. But we're working hard in the next couple of months, we will provide more clarity.

非常感謝你提出這個問題。所以簡短的回答是還沒有。但我們將在接下來的幾個月裡努力工作，我們將提供更多的清晰度。

Great. Thank you.

偉大的。謝謝。

Phil Nadeau, TD Cowen.

菲爾·納多，TD·考恩。

Good morning. Thanks for taking our question. One follow-up and then one actual question on -- from us. Tim, you've been very clear where gross to net is going. I'm still not entirely clear where gross to net actually was in Q3. Could you quantify what the gross to net was in Q3?

早安.感謝您提出我們的問題。一項後續行動，然後是我們提出的一個實際問題。提姆，您非常清楚毛淨值的走向。我仍然不完全清楚第三季的毛淨值實際上是多少。您能否量化第三季的毛淨額？

And then in terms of going forward, there's been some reports of vasculitis for IZERVAY in the adverse event database at the FDA. Has that had any impact on prescriber in the market from what you've seen? Curious to get your feedback from your feet on the street on those reports. Thanks.

就未來而言，FDA 的不良事件資料庫中有一些 IZERVAY 血管炎的報告。從您的觀察來看，這對市場上的處方醫生有什麼影響嗎？我很想得到您對這些報道的回饋。謝謝。

Yes. Thank you, Phil. So we previously had guided from the beginning of the launch of gross to net in the 10% to 20% range. And we had sort of earlier on been kind of in the middle-ish of that range. And this quarter, because of what we described as the perfect storm, we were at the high end of that. And that's about all I'm probably going to give in terms of accuracy there.

是的。謝謝你，菲爾。所以我們之前從推出之初就指導毛淨值在10%到20%的範圍內。我們早些時候處於該範圍的中間位置。本季度，由於我們所描述的完美風暴，我們正處於巔峰時期。這就是我可能要給出的關於準確性的全部內容。

Got it. Thank you.

知道了。謝謝。

Phil, you had a follow-up to that?

菲爾，你有後續行動嗎？

No, no, I was just saying thank you. That's very helpful.

不，不，我只是說謝謝。這非常有幫助。

As it relates to vasculitis, so we're not going to comment on our competitor's safety. But again, as we mentioned earlier, we believe that the only and real difference between the two products is on the efficacy profile where SYFOVRE stands out head and shoulders. We are the only product with the increasing effects over time with every-other-month dosing and with both foveal and subfoveal patients included in our data set.

由於它與血管炎有關，因此我們不會評論競爭對手的安全性。但正如我們之前提到的，我們相信這兩種產品之間唯一且真正的區別在於功效特徵，其中 SYFOVRE 脫穎而出。我們是唯一一款隨著時間的推移，每隔一個月給藥一次，且對中心凹和中心凹下患者都包含在我們的資料集中，效果逐漸增強的產品。

Great. That's helpful. Thank you.

偉大的。這很有幫助。謝謝。

Thank you.

謝謝。

Akash Tewari, Jefferies.

阿卡什·特瓦里，杰弗里斯。

Hi. This is Kathy on for Akash. It seems like your competitor is spending on promotional efforts for IZERVAY with an increase in SG&A spend associated with IZERVAY of $127 million for 6 months of sales of $185 million. So during a similar time period for SYFOVRE launch, so like around 1 year of approval, what was your return on investment?

你好。這是阿卡什的凱西。您的競爭對手似乎正在為 IZERVAY 進行促銷活動，與 IZERVAY 相關的 SG&A 支出增加了 1.27 億美元，6 個月的銷售額為 1.85 億美元。那麼，在 SYFOVRE 推出的相似時期，也就是大約 1 年的核准時間裡，您的投資報酬率是多少？

And then in the long term, what are the ROI levels you're targeting? And more specifically for your DTC spend in 2025, do you think it will be much different from the spend this year since you're investing in DTC this year already? Thank you.

從長遠來看，您的目標投資報酬率是多少？更具體地說，對於您 2025 年的 DTC 支出，您認為這與今年的支出會有很大不同嗎，因為您今年已經投資了 DTC？謝謝。

Yes. So thank you. I'll quickly start out and I'll turn it over to Adam. So we don't actually break out exactly what we're spending specifically on commercial for SYFOVRE. Obviously, we work hand-in-hand with Adam on those amounts. And we really haven't -- as a finance group, we haven't really constrained those efforts, we've just tried to be as efficient as possible based on things like metrics like ROI. And for that answer, I'll turn it over to Adam.

是的。所以謝謝你。我很快就會開始，然後把它交給 Adam。因此，我們實際上並沒有具體透露我們在 SYFOVRE 的商業廣告上的具體支出。顯然，我們在這些金額上與 Adam 攜手合作。我們確實沒有——作為一個財務集團，我們並沒有真正限制這些努力，我們只是試圖根據投資回報率等指標盡可能提高效率。對於這個答案，我將把它交給亞當。

Yes. Thanks, Kathy. So we look at every initiative from an ROI perspective. So we analyze it internally on a regular monthly cadence and take a big initiative like disease state education pivoting to DTC with Henry Winkler. We do a robust ROI analysis on that. We actually believe that, that's a really, really sound sophisticated business approach for us, and it drives many, many more patients in. So it's a very positive ROI for DTC.

是的。謝謝，凱西。因此，我們從投資報酬率的角度來看每一項舉措。因此，我們每月定期進行內部分析，並採取一項重大舉措，例如與亨利溫克勒 (Henry Winkler) 一起開展疾病狀態教育，轉向 DTC。我們對此進行了穩健的投資報酬率分析。我們實際上相信，這對我們來說是一種非常非常複雜的商業方法，它會吸引更多的患者加入。因此，這對 DTC 來說是非常積極的投資報酬率。

So that's the type of analysis we do. This is a really, really big market and we've only just started to scratch the surface. So the more effective we are in executing our plan and balancing what that looks like from an ROI perspective, the better the results will be.

這就是我們所做的分析類型。這是一個非常非常大的市場，而我們才剛開始觸及表面。因此，我們越有效地執行計劃並從投資回報率的角度平衡計劃，結果就會越好。

Great. Thank you so much.

偉大的。太感謝了。

Ellie Merle, UBS.

艾莉·梅爾，瑞銀。

Hey, guys. Thanks for taking my question. I want to talk a little bit more about the volume trends that you're seeing. So specifically, you said that you expect the sales ramp to be more gradual going forward. Just in terms of vial shift, does that mean we should expect similar vial growth in 4Q as in Q3? And just any more details you can give us on the volume trends you're seeing so far in October? Thanks.

嘿，夥計們。感謝您提出我的問題。我想多談談您所看到的數量趨勢。具體來說，您說您預計未來的銷售成長將更加緩慢。就小瓶轉移而言，這是否意味著我們應該預期第四季的小瓶成長與第三季類似？您能否向我們提供有關 10 月迄今為止所看到的成交量趨勢的更多詳細資訊？謝謝。

So I think that we did give some guidance in the prepared remarks on the vial growth, and we sort of said mid percentages roughly is what to expect, low to mid percentage vial growth, right? So beyond that, I don't think we're planning on guidance for the quarter.

所以我認為我們確實在準備好的關於小瓶增長的評論中給出了一些指導，我們說中等百分比大致是預期的，低到中等百分比的小瓶增長，對嗎？除此之外，我認為我們不會計劃為本季提供指導。

Okay.

好的。

Annabel Samimy, Stifel.

安娜貝爾·薩米米，斯蒂菲爾。

Hi. Thanks for taking my question. So I guess from the initial launch, it looks like you've got a lot of the low-hanging fruit and now it's a bigger push to get more. What are you seeing in terms of dynamic referrals? Like when a patient comes into the retinal specialists from the ophthalmologist or the optometrist, are they coming in for monitoring now or treatment? Are they typically severe enough to treat? Or are they still in a watchful waiting mode?

你好。感謝您提出我的問題。所以我想從最初的發布開始，看起來你已經獲得了很多唾手可得的成果，現在需要更大的努力才能獲得更多。您對動態推薦有何看法？就像當患者從眼科醫生或驗光師那裡來到視網膜專家處時，他們現在是來接受監測還是接受治療？它們通常嚴重到需要治療嗎？或者他們仍然處於觀察等待模式？

And then you mentioned six conversations to convert a retinal specialist who wasn't an early adopter. Does this get worse as these patients from the optometrists and the ophthalmologists come in because there may be less severe? I just wanted to understand the dynamic there of what types of patients you're starting to see from those specialists -- from those -- from that group?

然後您提到了六次對話，以改變一位不是早期採用者的視網膜專家。隨著驗光師和眼科醫生的這些患者進來，情況是否會變得更糟，因為可能不太嚴重？我只是想了解你開始從那些專家——從那些——從那個群體看到什麼類型的病人的動態？

Thank you, Annabel. So that is a really important and good question, right? So I think what was actually really great in the last few months is that kind of the uncertainties, people not knowing how to think about efficacy, how to think about safety, et cetera. That is slowly dissipating, right?

謝謝你，安娜貝爾。所以這是一個非常重要且很好的問題，對嗎？所以我認為過去幾個月真正重要的是這種不確定性，人們不知道如何考慮功效、如何考慮安全性等等。那是慢慢消散的吧？

So we're going to end up next year in a situation where kind of from a -- with a lot of data available to us, both from our trials, but now also as Caroline alluded to -- from the real world and that data looks very good, the states where physicians and patients can make an educated decision on treatment. And that's something that we really look forward to. Caroline, I don't know if you want to add something to that?

因此，明年我們將面臨這樣一種情況：我們可以獲得大量數據，這些數據都來自我們的試驗，但現在也正如卡羅琳提到的那樣——來自現實世界和這些數據看起來非常好，醫生和患者可以在治療上做出明智的決定。這是我們真正期待的事。卡洛琳，我不知道你是否想補充一些東西？

Sure. I can add from what my colleagues are telling me and from what I'm seeing myself, this is a novel mechanism of action and we have a new treatment paradigm. And there are still many patients who are coming into the office. We're always having patients referred with macular degeneration of all types, whether it's early or there are patients who have later stages of the disease.

當然。我可以根據我的同事告訴我的以及我自己的所見補充，這是一種新穎的作用機制，我們有一個新的治療範例。而且還有很多病人正在走進辦公室。我們總是有患有各種類型黃斑部病變的患者轉診，無論是早期患者還是晚期患者。

And so we're still seeing a whole host of different types of patients. I think that physicians are having conversations with their patients and they really center around efficacy. Now of course, whenever we have a treatment safety also plays a role, but patients are really driven by efficacy and the flexibility of dosing with 6 injections a year.

因此，我們仍然看到大量不同類型的患者。我認為醫生正在與患者進行對話，他們真正關注的是療效。當然，現在無論何時進行治療，安全性也發揮著重要作用，但患者真正受到療效和每年 6 次注射的劑量靈活性的驅動。

And then I think the other thing that moves the needle for physicians is we have a lot of long-term robust data. In addition to GALE, where patients have already had five years of full treatment, we have a real-world GARLAND study. And then there are four real-world studies done unrelated to Apellis and that really, in many ways, speaks more to physicians.

我認為另一件對醫生有啟發的事情是我們擁有大量長期可靠的數據。除了 GALE（患者已經接受了五年的全面治療）之外，我們還有一項真實世界的 GARLAND 研究。還有四項與 Apellis 無關的現實世界研究，這些研究在許多方面確實對醫生有更多啟發。

One of those studies has over 12,000 patients and those studies have shown robust reductions in GA lesion growth, photoreceptor preservation and all of the things that we have found, so just confirming our data. Go ahead, Adam.

其中一項研究涉及超過 12,000 名患者，這些研究表明 GA 病變生長、光感受器保存以及我們發現的所有情況均大幅減少，因此只是證實了我們的數據。繼續吧，亞當。

Annabel, it's Adam. Just on the final part of your question, so we are educating optometrists and ophthalmologists so that the patient also is aware as they progress to a retina physician about their disease and what treatment could possibly look like. We are actually hearing a lot from the fields that patients go in saying, I want the Henry Winkler drug, and that type of activity. So these patients are educated and are learning about the disease.

安娜貝爾，是亞當。關於你問題的最後一部分，我們正在對驗光師和眼科醫生進行教育，以便患者在去看視網膜醫生時也了解他們的疾病以及可能的治療方法。實際上，我們從現場聽到很多患者說，我想要亨利溫克勒藥物，以及這類活動。因此，這些患者接受了教育並了解了這種疾病。

We find it takes between six to nine conversations to get a new physician on board with the efficacy and the benefit/risk for SYFOVRE. So we have the capability of getting time with these physicians. Access is not a problem. And we'll continue to execute as flawlessly as we can.

我們發現需要六到九次對話才能讓新醫生了解 SYFOVRE 的功效和益處/風險。所以我們有能力抽出時間與這些醫生會面。訪問不是問題。我們將繼續盡可能完美地執行。

Okay. Thank you.

好的。謝謝。

Francois Brisebois, Oppenheimer.

弗朗索瓦·布里斯布瓦，奧本海默。

This is [Dan] on for Frank. Just a quick one from us. I'm sorry if you touched on this, but the uptick in new patients in the recent weeks, could you give us any color in terms of what factors may have contributed to that? Anything around that recent uptick.

這是弗蘭克的[丹]。我們只是簡單介紹一下。如果您談到這一點，我很抱歉，但是最近幾週新患者的增加，您能否告訴我們哪些因素可能導致了這種情況？圍繞最近的上漲的任何事情。

Yes. Thanks, Dan. Yes, we continue -- we did dip below and we're below 50% and we're back and stable at approximately 50%, and that uptick has been stable. I think it's down to us executing our plan on the benefits and the efficacy that SYFOVRE can bring: increasing effects over time, flexible dosing, well-documented safety and the significant real-world experience. And I think that's starting to resonate with our current prescriber base, but also all of these new physicians that we're targeting. So we will continue to execute as flawlessly as we can.

是的。謝謝，丹。是的，我們繼續——我們確實跌破了，低於 50%，但我們又回來了，穩定在 50% 左右，而且上升一直很穩定。我認為這取決於我們執行 SYFOVRE 所能帶來的好處和功效的計劃：隨著時間的推移，效果不斷增強、劑量靈活、安全性有據可查，以及重要的現實經驗。我認為這開始引起我們目前的處方者基礎的共鳴，也引起我們針對的所有新醫生的共鳴。因此，我們將繼續盡可能完美地執行。

Douglas Tsao, H.C. Wainwright.

雪兒 (Douglas Tsao)溫賴特。

Hi, good morning. Thanks for taking my question. Maybe, Adam, just as a follow-up on that. I'm just curious in terms of if you could provide some color in terms of the messaging and what resonated with physicians to drive a rebound in share? Was it really that physicians simply weren't aware of some of these efficacy differentiation points? Have they lost focus on it? Perhaps were they sort of under a mistaken impression on the rate of vasculitis events?

嗨，早安。感謝您提出我的問題。也許，亞當，只是作為後續行動。我只是好奇你是否可以在訊息方面提供一些色彩，以及哪些內容能引起醫生的共鳴以推動份額反彈？難道醫師真的根本不知道其中一些療效差異點嗎？他們是否失去了注意力？也許他們對血管炎事件的發生率有某種錯誤的印象？

Yes. Great question, Doug. We did see a lot of what you've described. So we have simplified our efficacy messages so that we can get them across field-based interactions and digital interactions around the strong efficacy, up to 42% in non-subfoveal patients, flexible dosing and well-documented safety.

是的。好問題，道格。我們確實看到了很多你所描述的內容。因此，我們簡化了療效信息，以便我們能夠圍繞強大的療效（在非中心凹下患者中高達42%）、靈活的劑量和有據可查的安全性，讓它們通過基於現場的交互和數字交互。

We have been very transparent on our safety and we have communicated that to physicians to make sure that people understand the fact base behind our efficacy as well as our safety. And that's what we will continue to hit. And that, I think, part of the plan of what's leading to the stability that we're seeing in the market. Caroline, I don't know if you want to add anything from a physician perspective.

我們對我們的安全性非常透明，我們將這一點傳達給醫生，以確保人們了解我們的功效和安全性背後的事實基礎。這就是我們將繼續努力的目標。我認為，這是導致我們在市場上看到的穩定計劃的一部分。卡羅琳，我不知道你是否想從醫生的角度添加任何內容。

Thank you, Adam. I think another important thing is that we're very aligned with the ReST Committee and the ASRS, and that is an organization that's retina physicians run by retina physicians it's their organization. And physicians really take confidence in that we're working with them. The rate hasn't changed and they've seen no unsuspected events. So that based on the real-world data that's come into play has really increased confidence amongst right adopters.

謝謝你，亞當。我認為另一件重要的事情是，我們與 ReST 委員會和 ASRS 非常一致，這是一個由視網膜醫生管理的組織，也是他們的組織。醫生們對我們與他們的合作充滿信心。比率沒有改變，他們也沒有看到任何意外事件。因此，基於正在發揮作用的現實世界數據確實增加了正確採用者的信心。

And I guess just as a follow-up, I mean, between all those factors that you mentioned, Adam and Caroline, I mean, was there one in particular that you thought was perhaps -- or you've gotten feedback was misunderstood in the marketplace and as your reps have gone out sort of has been corrected?

我想，作為後續行動，我的意思是，在你提到的所有這些因素中，亞當和卡羅琳，我的意思是，是否有一個你認為可能是特別的因素——或者你得到的反饋被誤解了市場以及您的銷售代表離開後是否已得到糾正？

Yes, Doug, we've been consistent that we believe that this is a market that's going to be driven on efficacy. And we get some incredibly positive recall data and knowledge from physicians on the efficacy messages once we've hit them, and it does take a little bit of time for them to resonate. So we think efficacy is changing the curve.

是的，道格，我們一直堅信這是一個由功效驅動的市場。一旦我們擊中了功效訊息，我們就會從醫生那裡得到一些令人難以置信的積極回憶數據和知識，而它們確實需要一點時間才能產生共鳴。所以我們認為功效正在改變曲線。

Okay. Great. Thank you so much.

好的。偉大的。太感謝了。

Lachlan Hanbury-Brown, William Blair.

拉克蘭·漢伯里-布朗、威廉·布萊爾。

Hey, thanks for taking my question. We've already had a few questions this morning around the October trends for SYFOVRE. It sounds like you've recovered new patient share and you're seeing decent growth, but you're also guiding to sort of low to mid-single-digit volume growth in the fourth quarter. So can you just sort of reconcile some of those October trends that you've talked about with the full quarter commentary?

嘿，謝謝你回答我的問題。今天早上我們已經就 SYFOVRE 十月趨勢提出了一些問題。聽起來您已經恢復了新的患者份額，並且看到了不錯的增長，但您也預計第四季度的銷量將出現低至中個位數的增長。那麼，您能否將您所討論的一些 10 月趨勢與整個季度評論進行協調？

Sure. Listen, I'll just start out and then I'll turn it over to Adam. What Adam said is what we can -- obviously what we see. We've seen new patient share approaching 50%. We've also seen, as you can see, the market is still growing, but it was growing at a little bit of a slower rate in the last quarter. So I think our confidence over the long term is quite strong that the efficacy profile of SYFOVRE will dominate over time. But in the short term, these dynamics take some time to take effect, right?

當然。聽著，我先開始，然後把它交給亞當。亞當所說的是我們能做到的——顯然是我們所看到的。我們發現新患者比例接近 50%。正如您所看到的，我們還看到市場仍在成長，但上個季度的成長速度有點慢。因此，我認為從長遠來看，我們對 SYFOVRE 的功效特徵將在一段時間內佔據主導地位充滿信心。但從短期來看，這些動力需要一段時間才能生效，對吧？

We have certain initiatives we're putting in place like DTC and others that we've described, as Adam talked about, but those don't have an immediate impact. So from the perspective of what we can see this quarter, I think it was prudent to take that approach and just say, look, low to mid-single-digit growth in the vial basis and flat to moderate growth on a revenue basis. I don't know if you want to comment more, Adam.

正如 Adam 所說，我們正在實施一些舉措，例如 DTC 和我們所描述的其他舉措，但這些舉措不會立即產生影響。因此，從我們本季看到的情況來看，我認為採取這種方法是謹慎的，只是說，看，小瓶基礎上的低至中個位數增長，以及收入基礎上的持平至中等增長。我不知道你是否想發表更多評論，亞當。

No, I think you said it really well.

不，我覺得你說得很好。

Derek Archila, Wells Fargo.

德里克·阿奇拉，富國銀行。

Hey, guys. Thanks for taking my question. So just I wanted some help reconciling your comments on reaching profitability with current cash while anticipating flat to modest sales growth. I guess, what type of growth does that imply for SYFOVRE in 2025 and beyond? And I guess, maybe on the flip side, what levels of OpEx? And then another just to squeeze in, I guess, should we assume the sale of receivables is part of that funding strategy to profitability? Thanks.

嘿，夥計們。感謝您提出我的問題。因此，我只是想要一些幫助來協調您關於利用當前現金實現盈利的評論，同時預計銷售增長將持平或適度。我想，這對 SYFOVRE 在 2025 年及以後意味著什麼類型的成長？我想，也許另一方面，營運支出是多少？然後另一個只是為了擠進去，我想，我們是否應該假設應收帳款的銷售是獲利融資策略的一部分？謝謝。

Sure. Thank you. That's a great question. So look, we ended the quarter with about $400 million in cash. That included a sale of roughly $57 million in receivables. So that was -- obviously, you've read the Q. So congratulations. Thank you. Look, when you look at our operating expense that's on a cash basis, you exclude onetime items of about $15 million on the COGS line and then our cash OpEx of roughly $180 million on the SG&A and R&D lines, you get to the fact that we're basically neutral on net revenue to cash operating expenses basis. And beyond that, we had a net interest of around $10 million.

當然。謝謝。這是一個很好的問題。所以看，本季結束時我們有大約 4 億美元的現金。其中包括出售約 5,700 萬美元的應收帳款。顯然，您已經閱讀了問題。謝謝。看，當您查看我們以現金為基礎的營運費用時，您排除了COGS 行中約1500 萬美元的一次性項目，然後排除了SG&A 和R&D 行中約1.8 億美元的現金營運支出，您會發現我們在淨收入與現金營運支出的基礎上基本上是中性的。除此之外，我們的淨利息約為 1000 萬美元。

So you're looking at kind of $10 million in operating burn and the rest of this sort of cash usage relates to working capital. And for that, we put in place this ability to monetize our receivables a little bit earlier because we extend these receivables quite significantly as much as five months -- four months to five months.

因此，您將看到大約 1000 萬美元的營運消耗，其餘的現金使用與營運資金有關。為此，我們提前一點將應收帳款貨幣化，因為我們將這些應收帳款大幅延長了五個月——四個月到五個月。

So from our perspective, that's really just bringing in cash that's ours a little bit early. But you can see from an operating level, we are pretty much nearing, if not around breakeven. So our perspective is it doesn't take much growth to make us cash flow positive. And obviously, we have a lot of faith in the long term of this product, as we've talked about. We also have C3G coming on. So we don't see any immediate need or risk from a capital perspective.

因此，從我們的角度來看，這實際上只是提前帶來了屬於我們的現金。但從營運水準來看，我們已經非常接近損益平衡點了。因此，我們的觀點是，不需要太多的成長就能使我們的現金流為正。顯然，正如我們所討論的，我們對該產品的長期發展充滿信心。我們還將推出 C3G。因此，從資本角度來看，我們不認為有任何迫切的需求或風險。

Got it. Thank you.

知道了。謝謝。

Biren Amin, Piper Sandler.

比倫·阿明，派珀·桑德勒。

Hi, guys. Thanks for taking my question. Can you maybe talk about how many switches you're seeing from IZERVAY as part of the new patient share growth that you're experiencing in the last half of Q3? And for 2025, what's the SG&A increase that we should expect for C3, MPG? And I think Novartis mentioned that they have about 100-plus person sales force dedicated to nephrology. Thank you.

嗨，大家好。感謝您提出我的問題。您能否談談您在第三季後半段經歷的新病患份額成長的一部分，從 IZERVAY 看到了多少轉換？到 2025 年，我們預期 C3、MPG 的 SG&A 成長是多少？我想諾華提到他們有大約 100 多人的銷售隊伍專門從事腎臟病學工作。謝謝。

Biren, yes, it's Adam. So switching first on SYFOVRE. So obviously, our data analysis suggests that switching does occur, but we actually think it doesn't happen that frequently. Hence, we're executing our plan to grow depth and breadth in accounts and bring on new young prescribers to our business. We think that's what's really going to move the needle forward.

比倫，是的，是亞當。所以先切換到 SYFOVRE。顯然，我們的數據分析表明確實會發生轉換，但我們實際上認為這種情況不會經常發生。因此，我們正在執行我們的計劃，以擴大客戶的深度和廣度，並為我們的業務引入新的年輕處方醫生。我們認為這才是真正推動進步的因素。

When it comes to infrastructure for the nephrology indications, so we're doing that homework now. We obviously have a really small, but mighty PNH infrastructure, which we will leverage to move into the kidney. So we're doing our homework there to look at the target population and what field force structure that we would need to compete to get those patients with the great profile that EMPAVELI is showing.

當談到腎臟病學適應症的基礎設施時，我們現在正在做這項工作。顯然，我們擁有一個非常小但強大的 PNH 基礎設施，我們將利用它進入腎臟。因此，我們正在那裡做功課，了解目標人群，以及我們需要競爭什麼樣的現場力量結構，才能讓這些患者擁有 EMPAVELI 所展示的出色形象。

And maybe adding one thing to that -- or two things to that. On the switches, there are switches occurring in both directions, right? I mean, as again, this field will settle and there's a couple of things still that we need to see materialize in the next couple of months in both directions.

也許還可以增加一件事——或者兩件事。在開關上，雙向都有開關，對吧？我的意思是，這個領域將會穩定下來，我們仍然需要看到一些事情在接下來的幾個月裡在兩個方向上實現。

The other aspect is, as it relates to C3G and IC-MPGN, again, reiterating the fact that we were not asked to submit the 12-month data, but the 6-month data was sufficient. We had a pre-NDA meeting that was scheduled with our team in Washington. Meeting got canceled because of all questions were answered. So again, a very exciting program for us that we think will add meaningfully to what we are doing.

另一方面，因為涉及C3G和IC-MPGN，再次重申我們沒有被要求提交12個月的數據，但6個月的數據就足夠了。我們與我們的團隊在華盛頓舉行了一次 NDA 前會議。由於所有問題均已解答，會議取消。再說一遍，這對我們來說是一個非常令人興奮的計劃，我們認為它將為我們正在做的事情增添有意義的內容。

Great. Thank you.

偉大的。謝謝。

Lisa Walter, RBC.

麗莎·沃爾特，加拿大皇家銀行。

Hi, guys. Thanks so much for taking my question. Maybe just one on SYFOVRE and given the recent negative CHMP opinion and also your competitor withdrawing from filing in the EU. How are you thinking about the possibility of potential approval and other ex US geographies, particularly UK, Australia, Canada, Switzerland? And also beyond those four countries, are there any other large foreign markets that are also on your radar? Thanks for taking the question.

嗨，大家好。非常感謝您提出我的問題。考慮到最近 CHMP 的負面意見以及您的競爭對手撤回在歐盟提交的申請，也許只是 SYFOVRE 上的一篇。您如何看待潛在批准的可能性以及其他美國以外地區，特別是英國、澳洲、加拿大、瑞士？除了這四個國家之外，還有其他大型國外市場也在您的關注範圍內嗎？感謝您提出問題。

Lisa, it's Adam. Yes, thanks for your question. so obviously, we still progress with the UK, Switzerland, Canada and Australia. Those are countries that are outside of EMA's guidance that used to be within something called the Access Consortium. So we continue to have positive and robust conversations with those geographies.

麗莎，是亞當。是的，謝謝你的提問。顯然，我們仍在與英國、瑞士、加拿大和澳洲取得進展。這些國家不屬於 EMA 的指導範圍，而這些國家曾經屬於 Access Consortium 的範圍。因此，我們繼續與這些地區進行積極而有力的對話。

We also will move forward in areas where the US file is required. So we started to build a lean infrastructure in Brazil to get ready for those regulatory interactions. And we have distributors who will help partner with us to get to other smaller markets where the US filing is accepted. So we still see a really large unmet need outside of the US when it comes to geographic atrophy and we're executing country by country.

我們還將在需要美國文件的領域取得進展。因此，我們開始在巴西建立精實基礎設施，為這些監管互動做好準備。我們的經銷商將幫助我們與我們合作，進入接受美國申請的其他較小市場。因此，在地理萎縮方面，我們仍然看到美國以外的巨大需求未被滿足，而且我們正在逐個國家執行。

Got it. Thanks so much.

知道了。非常感謝。

Greg Harrison, Scotiabank.

格雷格·哈里森，豐業銀行。

Hey, good morning. Thanks for taking my question. Looking at the feedback from ASN, everything was very positive there. Are you able to provide any additional color on physician feedback now that they've had some time to digest the data from the conference? And how are you thinking about your competitive positioning in those indications in the shorter and longer term? Thanks.

嘿，早安。感謝您提出我的問題。從 ASN 的回饋來看，一切都非常正面。既然醫生已經有時間消化會議的數據，您是否能夠對醫生的回饋提供任何額外的資訊？您如何看待您在這些適應症中的短期和長期競爭定位？謝謝。

Thank you so much, Greg. Thank you for asking the question about the kidney, something we're really excited about. And to your point, ASN was a very pleasant conference for us to attend. The reality here is that if you are a teenager with C3 or IC-MPGN and with the data that we have, we believe that you have an opportunity to never have to worry about being on hemodialysis or requiring transplant. Think about that, right? I mean, that is what this data really represents.

非常感謝你，格雷格。感謝您提出有關腎臟的問題，我們對此感到非常興奮。就您而言，ASN 對我們來說是一次非常愉快的會議。現實情況是，如果您是患有 C3 或 IC-MPGN 的青少年，並且根據我們掌握的數據，我們相信您有機會永遠不必擔心接受血液透析或需要移植。想想看，對嗎？我的意思是，這就是這些數據真正代表的內容。

So really excited about that competitively. As I mentioned before, we are -- we have a very different profile on three important endpoints on proteinuria reduction, of course, but also on eGFR stabilization and importantly on C3c staining where we saw these dramatic effects. And Caroline, maybe you want to add something to that?

對此感到非常興奮。正如我之前提到的，我們在蛋白尿減少的三個重要終點上有非常不同的概況，當然，在 eGFR 穩定方面，以及重要的是在 C3c 染色方面，我們看到了這些顯著的效果。卡羅琳，也許你想補充一些東西？

Sure. Thank you. Well, it was my first nephrology meeting. And I can say across the Board, the clinicians were so excited about these findings. I mean, to see this sort of effect is really remarkable. And I think one thing that was really important for them was that the effect started as early as four weeks in these patients.

當然。謝謝。嗯，這是我第一次參加腎臟科會議。我可以說，臨床醫生對這些發現非常興奮。我的意思是，看到這種效果真的很了不起。我認為對他們來說真正重要的一件事是，這些患者的效果早在四週就開始顯現。

And as a physician, why wait for kidney disease to get worse, it might get worse to the point that it's irreversible, right? And these patients are often young in our studies, the mean age for patients in their 20s. So they were really excited to give them something that worked and worked quickly and could prevent them from having a negative outcome. So across the Board, everyone was very excited for this.

身為醫生，為什麼要等到腎臟疾病惡化，它可能會惡化到不可逆轉的地步，對吧？而且在我們的研究中這些患者往往很年輕，患者的平均年齡在20多歲。因此，他們非常高興能夠為他們提供一些有效且快速有效的東西，並且可以防止他們產生負面結果。因此，總的來說，每個人都對此感到非常興奮。

Jon Miller, Evercore. Moving forward to our next question.

喬恩‧米勒，《Evercore》。繼續我們的下一個問題。

Graig Suvannavejh, Mizuho Securities.

Graig Suvannavejh，瑞穗證券。

Good morning. Thanks for taking my question. My question is on your longer term and perhaps aspirational view around potential peak penetration of the complement inhibitor class, you've been great about providing granularity on current penetration, which I believe you said earlier might be at about 15%. But longer term, where do you think 15% can go? And how long do you think it might take to get there? Thanks.

早安.感謝您提出我的問題。我的問題是關於您對補體抑制劑類潛在峰值滲透的長期觀點，也許是理想的觀點，您非常擅長提供當前滲透的粒度，我相信您之前說過可能約為 15%。但從長遠來看，你認為 15% 可以去哪裡？您認為到達那裡可能需要多長時間？謝謝。

Thank you, Greg. Caroline?

謝謝你，格雷格。卡洛琳？

Well, I think that no one should be surprised of this treatment. And our patients are only getting older. And these patients come in, whether it's for AMD, for cataract. We have so much education that we could do not just with optometrists, but across the eye care provider market, which is more than just optometrists and retina. So I think that, hopefully, we will continue. It's a chronic disease. We'll continue to have the penetration go up. We're just really at the start.

好吧，我認為沒有人應該對這種治療感到驚訝。而我們的病人只會越來越老。這些患者前來就診，無論是AMD或白內障。我們接受瞭如此多的教育，我們不僅可以與驗光師合作，還可以在整個眼保健提供者市場上合作，這不僅僅是驗光師和視網膜。所以我認為，希望我們能夠繼續下去。這是一種慢性疾病。我們將繼續提高滲透率。我們才剛開始。

Laura Chico, Wedbush Securities.

勞拉·奇科，韋德布希證券。

Good morning. Thank you so much. Two clarifications for me. Just following up on the cash runway guidance. Just wanted to clarify, does that incorporate a C3G launch and revenue contribution? And then second, I think I might have missed it, but the average number of injections per patient, how has that changed over the course of the launch here? Thanks so much.

早安.太感謝了。對我來說有兩個澄清。只是跟進現金跑道指導。只是想澄清一下，這是否包含 C3G 的推出和收入貢獻？其次，我想我可能錯過了，但是每個患者的平均注射次數在推出過程中發生了怎樣的變化？非常感謝。

Thank you very much, Laura. I'll take, obviously, the first question. It absolutely does. The incremental cost for C3G launch would not be massive in terms of expenditure relative to where we are and -- so that absolutely does.

非常感謝你，勞拉。顯然，我將回答第一個問題。確實如此。相對於我們目前的支出而言，C3G 推出的增量成本不會很大，所以絕對是如此。

Laura, it's Adam, to your second part of the question. So every-other-month dosing or that flexibility to push to every-other-month dosing has been really stable at 80% to 90% of all of SYFOVRE's prescriptions. Physicians and patients believe in the efficacy and the flexibility of every other month dosing. So we expect that to stay the same as we move forward.

蘿拉，我是亞當，回答你問題的第二部分。因此，每隔一個月給藥一次或推動每隔一個月給藥一次的靈活性確實穩定在 SYFOVRE 所有處方的 80% 至 90%。醫生和患者相信每隔一個月給藥一次的有效性和靈活性。因此，我們希望在我們前進的過程中保持不變。

Jon Miller.

喬恩·米勒。

Hi, guys. Thanks for taking my follow up here. I'd love to ask more on the kidney indications. How do you expect -- obviously, it's a little early to discuss eventual label. But given you've got data in C3G, IC-MPGN both pre- and post-transplant, how do you expect your potential label to look relative to Novartis' considering the differences in trial design? And do you expect that proteinuria efficacy differences aside, is the patient population going to be materially broader for you guys?

嗨，大家好。感謝您在這裡關注我。我想詢問更多有關腎臟適應症的問題。你有何期望——顯然，現在討論最終的標籤還為時過早。但考慮到您已經獲得了移植前和移植後的 C3G、IC-MPGN 數據，考慮到試驗設計的差異，您預計您的潛在標籤相對於諾華的標籤看起來如何？除了蛋白尿療效差異之外，您是否預期患者群體對您來說會更廣泛？

Thank you, Jon. So that is -- we're not going to comment on what we expect in the label. But to your point, we studied pediatric adults, pre-transplant, post-transplant, C3G and IC-MPGN and all levels of C3 concentration, right? I mean, our competitor studied only patients with C3G, only in adults, only pre-transplant and only in patients that had C3 depletion. So it's really a very narrow population compared to what we studied in VALIANT where across the board we saw the same efficacy profile.

謝謝你，喬恩。所以，我們不會對標籤中的預期內容發表評論。但就您的觀點而言，我們研究了成人兒童、移植前、移植後、C3G 和 IC-MPGN 以及所有水平的 C3 濃度，對吧？我的意思是，我們的競爭對手僅研究了 C3G 患者、成人患者、移植前患者以及 C3 耗盡的患者。因此，與我們在 VALIANT 中研究的人群相比，這實際上是一個非常狹窄的人群，我們在所有方面都看到了相同的功效概況。

And again, the benefit of being able to file with the 6-month data as a reflection of the robustness and the quality of what we were able to establish. So again, we believe that this is a treatment that may offer the possibility to an adolescent to never have to worry about hemodialysis or a transplant.

再說一次，能夠提交 6 個月數據的好處是，它反映了我們能夠建立的內容的穩健性和品質。因此，我們再次相信，這種治療可以為青少年提供永遠不必擔心血液透析或移植的可能性。

And there are at least 5,000 patients, we believe, in the US with this condition, of which are already 1,000 to 1,500 are transplanted and at risk of relapsing. So really important indication and we believe a tremendous first line and all-encompassing solution for these patients.

我們相信，在美國至少有 5,000 名患者患有這種疾病，其中 1,000 至 1,500 名患者已經接受了移植，並且有復發的風險。這是非常重要的適應症，我們相信對這些患者來說這是一個巨大的第一線和全方位的解決方案。

And I would now like to turn the call back to Cedric for closing remarks.

現在我想將電話轉回給塞德里克，讓他發表結束語。

Thank you so much. And thank you, everyone, for joining us this morning. If you have any follow-up questions, feel free to contact Meredith, and we look forward to speaking with many of you today. Thank you so much.

太感謝了。感謝大家今天早上加入我們。如果您有任何後續問題，請隨時聯繫梅雷迪思，我們期待今天與您中的許多人交談。太感謝了。

And this concludes today's conference. Thank you for your participation. You may now disconnect.

今天的會議到此結束。感謝您的參與。您現在可以斷開連線。