Apellis Pharmaceuticals Inc (APLS) 2025 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 2025 earnings conference call.

女士們、先生們，早安。感謝您的耐心等待，歡迎參加 Apellis Pharmaceuticals 2025 年第三季財報電話會議。

Please be advised that today's conference is being recorded. I would now like to turn the call over to Eva Stroynowski, Head of Investor Relations. Please go ahead.

請注意，今天的會議正在錄影。現在我將把電話交給投資人關係主管伊娃‧斯特羅伊諾夫斯基。請繼續。

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

早安，感謝各位參加本次關於 Apellis 2025 年第三季財務業績的討論。與我一同參加電話會議的還有共同創辦人兼執行長 Cedric Francois 博士；商業執行副總裁 David Acheson；首席醫療官 Caroline Baumal 博士；以及財務長 Tim Sullivan。

Before we begin, let me point out that we will be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and actual results may differ materially.

在開始之前，我想指出，我們將做出一些基於我們當前預期和信念的前瞻性陳述。這些聲明存在一定的風險和不確定性，實際結果可能與聲明內容有重大差異。

I encourage you to consult the risk factors discussed in our SEC filings for additional detail. Now I'll turn the call over to Cedric.

我建議您查閱我們在提交給美國證券交易委員會的文件中討論的風險因素，以了解更多詳情。現在我把電話交給塞德里克。

Thank you, Eva. Before diving into our third quarter results and portfolio progress, I want to briefly highlight the unmet need that Apellis set out to tackle and why we are uniquely positioned to address that challenge.

謝謝你，伊娃。在深入探討我們第三季的業績和投資組合進展之前，我想簡要地強調一下 Apellis 著手解決的未被滿足的需求，以及為什麼我們擁有獨特的優勢來應對這一挑戰。

Apellis is a commercial stage biotech company targeting the overactivation of the complement system, an innate defense mechanism in the immune system that protects the body from acute infection and illness.

Apellis 是一家商業化階段的生技公司，致力於治療補體系統的過度活化。補體系統是免疫系統中的一種先天防禦機制，可以保護身體免受急性感染和疾病的侵害。

However, when complement is chronically unregulated, there can be a devastating effect on ones health, driving a broad range of serious, often life-threatening diseases.

然而，當補體長期失調時，會對人的健康造成毀滅性的影響，引發一連串嚴重的、往往危及生命的疾病。

Most approved complement targeted therapeutics inhibit at C5, a downstream protein in the complement cascade. By only blocking this target, C5 inhibitors do not affect the upstream activity that drives inflammation and tissue damage.

大多數核准的補體標靶療法抑制的是補體級聯反應中的下游蛋白 C5。C5 抑制劑僅阻斷此靶點，並不影響驅動發炎和組織損傷的上游活性。

Similarly, inhibitors of factor B act earlier in the cascade and narrowly reduce alternative pathway amplification but allow classical and lectin pathway activity to persist, leaving some disease activity unchecked.

類似地，B因子抑制劑在級聯反應中更早發揮作用，並能輕微減少替代途徑的放大，但允許經典途徑和凝集素途徑的活性持續存在，從而使一些疾病活動無法控制。

Apellis science is founded on a simple but powerful idea, to address complement-driven diseases at their source by targeting C3, the central hub where all complement pathways converge. By doing this, we take a fundamentally different approach that enables comprehensive disease control at the root cause.

Apellis 的科學建立在一個簡單而強大的理念之上，即透過靶向 C3（所有補體途徑匯聚的中心樞紐）從根源上解決補體驅動的疾病。透過這種方式，我們採取了一種截然不同的方法，可以從根本上控制疾病。

For decades, the prevailing view was that C3 could not be effectively modulated because of its central role in immune defense. Apellis solved this challenge by engineering pegcetacoplan, a first-in-class C3 inhibitor that controls overactive complement while preserving essential immune function.

幾十年來，人們普遍認為 C3 無法被有效調節，因為它在免疫防禦中起著核心作用。Apellis 透過設計 pegcetacoplan 解決了這個難題，這是一種首創的 C3 抑制劑，可在控制過度活躍的補體的同時，維持必要的免疫功能。

The result is both a technological feat in drug design and a transformative clinical advancement for patients. This vision is what sets Apellis apart. We have mastered our core technology and redefined complement therapeutics.

這項研究成果既是藥物設計領域的技術壯舉，也是對病人而言具有變革意義的臨床進步。正是這種願景使Apellis脫穎而出。我們已經掌握了核心技術，並重新定義了補體療法。

The scientific advantage underpins our success to date. Having now translated decades of innovation into two approved medicines across four serious diseases, Apellis is a commercial stage leader with a truly differentiated C3 platform.

科學優勢是我們迄今為止成功的基石。Apellis 憑藉數十年的創新成果，已研發出兩種核准藥物，可用於治療四種嚴重疾病，是商業階段的領導者，擁有真正差異化的 C3 平台。

SYFOVRE is the first ever treatment for geographic atrophy, having shown robust efficacy in slowing disease progression in the broadest patient population. EMPAVELI has demonstrated best-in-class hemoglobin improvement in PNH and the ability to completely clear C3 deposits from the kidney.

SYFOVRE 是第一個用於治療地圖狀萎縮的藥物，已在最廣泛的患者群體中顯示出減緩疾病進展的顯著療效。EMPAVELI 已證明在 PNH 治療中具有一流的血紅蛋白改善效果，並且能夠完全清除腎臟中的 C3 沉積物。

Together, these achievements underscore our unprecedented clinical innovation and strengthen Apellis competitive edge in complement science. Turning now to our business results, the third quarter was a period of further progress where we continued to build on our strong performance.

這些成就共同凸顯了我們前所未有的臨床創新，並增強了 Apellis 在補體科學領域的競爭優勢。現在來看我們的業務成果，第三季我們取得了進一步的進步，繼續鞏固了我們強勁的業績。

A key milestone was the FDA approval of EMPAVELI for the treatment of patients 12 years and older with C3 glomerulopathy or primary immune complex membranoproliferative glomerulonephritis or ICMPGN.

一個重要的里程碑是 FDA 批准 EMPAVELI 用於治療 12 歲及以上患有 C3 腎小球病或原發性免疫複合物膜增生性腎小球腎炎或 ICMPGN 的患者。

This approval expands the addressable market for EMPAVELI by approximately 5,000 patients and marks a breakthrough therapy that delivers meaningful results across the trifecta of key disease control measures including proteinuria reduction, eGFR stabilization, and substantial clearance of C3 deposits.

這項批准將 EMPAVELI 的目標市場擴大了約 5,000 名患者，標誌著一項突破性療法的誕生，該療法在包括減少蛋白尿、穩定 eGFR 和大幅清除 C3 沉積物在內的三個關鍵疾病控制指標方面均取得了顯著成效。

With a broad label in hand, we are well positioned for launch in a space where physicians consistently note that efficacy will drive treatment decisions.

有了廣泛的標籤，我們就能很好地進入這個領域，因為醫生一直指出療效將決定治療方案。

David will share more on the launch progress shortly. Moving to SYFOVRE, geographic atrophy is a devastating disease that progressively and permanently robs patients of their vision.

David 稍後將分享更多關於發布進度的資訊。SYFOVRE 指出，地圖狀萎縮是一種毀滅性的疾病，它會逐漸且永久地剝奪患者的視力。

Unfortunately, in managing GA, many retina specialists have adopted a wait and see approach despite SYFOVRE’s well-established clinical profile that demonstrated robust, sustained, and increasing benefits with every other month dosing.

不幸的是，儘管 SYFOVRE 具有良好的臨床療效，證明每隔一個月給藥一次可帶來顯著、持續和不斷增加的益處，但在治療 GA 時，許多視網膜專家仍然採取了觀望態度。

Because of this, only about 10% of patients diagnosed with GA are treated with complement inhibitors today.

正因如此，目前只有約 10% 的 GA 患者接受補體抑制劑治療。

In the near term, we expect a period of steady, measured injection growth with the next inflection in growth to be driven by new tools and targeted market education initiatives that we plan to bring to market over the next 12 to 18 months.

短期內，我們預計會經歷一段穩定、穩定成長的時期，而下一次成長轉折點將由我們計劃在未來 12 至 18 個月內推向市場的新工具和有針對性的市場教育舉措所驅動。

We believe these initiatives will re-accelerate the adoption of complement treatments and grow the overall GA market. Overall, our focus remains on leveraging our expertise in complement-mediated diseases to positively affect the lives of people living with serious illnesses.

我們相信這些措施將重新加速補充療法的採用，並促進整個GA市場的成長。總的來說，我們的重點仍然是利用我們在補體介導疾病方面的專業知識，對患有嚴重疾病的人們的生活產生積極影響。

With this in mind, we continue to maximize our market opportunities for EMPAVELI, drive expansion for SYFOVRE, and advance our pipeline. I will now hand the call over to David for an update on our commercial activities.

基於此，我們將繼續最大限度地掌握 EMPAVELI 的市場機遇，推動 SYFOVRE 的擴張，並推進我們的研發管線。現在我將把電話交給大衛，讓他報告我們的商業活動狀況。

Thank you Cedric, and good morning everyone. I’ll start with EMPAVELI and the recent approval in C3G and primary ICMPGN. We are now two months into the launch, and I am very pleased with our progress so far.

謝謝你，塞德里克，大家早安。我將從 EMPAVELI 以及最近在 C3G 和主要 ICMPGN 中的批准開始。現在已經上線兩個月了，我對目前的進展非常滿意。

Feedback from the nephrology community has been outstanding, and we are carrying that momentum into Q4. In the US, we estimate there are approximately 5,000 C3G and primary ICMPGN patients.

腎臟病學界的回饋非常出色，我們將把這種勢頭延續到第四季。據估計，美國約有 5,000 名 C3G 和原發性 ICMPGN 患者。

Notably, EMPAVELI’s broad label makes it the first and only treatment approved for a comprehensive list of patient populations, including adult patients with C3G, adult patients with ICMPGN, pediatric patients with C3G, primary ICMPGN patients age 12 years and older, and patients with post-transplant C3G disease recurrence.

值得注意的是，EMPAVELI 的廣泛適應症使其成為第一個也是唯一一個獲準用於治療多種患者群體的藥物，包括患有 C3G 的成人患者、患有 ICMPGN 的成人患者、患有 C3G 的兒童患者、12 歲及以上的原發性 ICMPGN 患者以及移植後 C3G 疾病復發的患者。

EMPAVELI is the only approved therapy for approximately 2/3 of this 5,000 patient population, and we believe it offers highly differentiated efficacy for the other third where patients have an alternative.

對於這 5000 名患者中的約 2/3 而言，EMPAVELI 是唯一獲準的療法；我們相信，對於其他三分之一有其他選擇的患者，EMPAVELI 也具有高度差異化的療效。

Together, the broad label and the strong clinical data position the launch of EMPAVELI for long-term success.

廣泛的適應症標籤和強有力的臨床數據共同為 EMPAVELI 的上市奠定了長期成功的基礎。

For the first time, patients can be treated with a first-in-class C3 targeting therapy and the only complement therapy that has demonstrated its ability to preserve kidney function by controlling all three markers of these diseases, including proteinuria reduction, eGFR stabilization, and substantial clearance of C3 deposits.

患者首次可以接受首創的 C3 標靶療法，這也是唯一一種已證明能夠透過控制這些疾病的所有三個標記（包括蛋白尿減少、eGFR 穩定和 C3 沉積物大量清除）來保護腎功能的補體療法。

EMPAVELI is delivered through our compact, single-use on-body auto-injector. Patients can self-administer in the comfort of their own home without ever seeing a needle. Early feedback from the market has been exceptionally positive, highlighting its ease of use and the convenience of the twice-weekly dosing.

EMPAVELI 透過我們小巧的一次性體外自動注射器進行給藥。患者可以在自己舒適的家中自行注射，而無需見到針頭。市場早期回饋非常積極，強調了該產品的易用性和每週兩次給藥的便利性。

The PK profile of EMPAVELI allows patients the flexibility to take treatment on their own terms, avoiding twice-daily dosing required by the oral alternative.

EMPAVELI 的藥物動力學特性使患者能夠靈活地以自己的方式接受治療，避免了口服替代藥物所需的每日兩次給藥。

Ahead of the launch, we scaled our field-based teams to approximately 100 people, ensuring coverage of every US nephrologist managing these patients. Our extensive prelaunch engagement with physicians and patient identification efforts have built a strong foundation for a successful rollout.

在正式推出之前，我們將現場團隊規模擴大到約 100 人，確保覆蓋到每位管理這些患者的美國腎臟科醫生。我們在上市前與醫生進行了廣泛的溝通，並開展了患者識別工作，為成功推廣奠定了堅實的基礎。

As communicated in our approval call, the launch metric that we will be reporting early in launch is patient start forms. Through the end of September, we’ve received 152 patient start forms for EMPAVELI.

正如我們在審批電話會議中溝通的那樣，我們將在產品上市初期報告的上市指標是患者啟動表格。截至 9 月底，我們已收到 152 份 EMPAVELI 患者啟動表格。

Included in this number are the approximately 50 patients from our Expanded Access Program or EAP who are in the process of converting over to commercial drug. We remain on track to have these EAP patients on commercial drug by the end of this year.

其中包括我們擴大用藥計畫（EAP）中的大約 50 名患者，他們正在過渡到使用商業藥物。我們仍有望在今年底前讓這些 EAP 患者使用商業藥物。

As a reminder, it generally takes four to six weeks for a patient to start treatment. We see opportunities to potentially accelerate this time frame as we gain more experience in our launch and as payer policies are updated.

再次提醒，患者通常需要四到六週才能開始接受治療。隨著我們在產品上市方面累積更多經驗，以及支付方政策的更新，我們看到了加快這一進程的潛在機會。

During the quarter, we made meaningful inroads with high volume prescribers and are confident in the continued growth of adoption. Of the 20 most influential and high volume accounts in the space, 19 have a REMS certified prescriber and the majority of these centers have submitted STAR forms.

本季度，我們在大量開處方的醫生中取得了顯著進展，並對採用率的持續增長充滿信心。在該領域最具影響力和交易量最大的 20 個帳戶中，有 19 個帳戶擁有 REMS 認證的處方醫生，並且這些中心中的大多數都已提交了 STAR 表格。

Clear evidence that our launch efforts are translating into real world adoption across priority accounts. On the access front, we are encouraged by payers recognition of the value of EMPAVELI in C3G and primary ICMPGN and by the speed at which these patients are successfully gaining access to.

有明確證據表明，我們的推廣工作正在轉化為重點客戶的實際應用。在准入方面，我們感到鼓舞的是，支付方認可了 EMPAVELI 在 C3G 和原發性 ICMPGN 中的價值，並且這些患者能夠迅速獲得治療。

Furthermore, our dedicated Apellis Assist team is closely working with patients and prescribers to navigate the expected prior authorization requirements to minimize delays and support a smooth start to therapy.

此外，我們專業的 Apellis Assist 團隊正與患者和處方醫生密切合作，以應對預期的事先授權要求，從而最大限度地減少延誤，並支持治療的順利開始。

These have been incredibly encouraging early weeks for a rare disease launch and we are excited by the strong engagement from both physicians and patients.

對於一款罕見疾病產品來說，這幾週的上市初期進展令人鼓舞，我們對醫生和患者的積極參與感到非常興奮。

We are learning a great deal about prescriber habits and once physicians are educated on the differentiated profile of our therapy, they quickly become strong believers in its disease modifying potential.

我們正在深入了解醫生的處方習慣，一旦醫生們了解了我們療法的獨特之處，他們很快就會堅信這種療法具有改變疾病的潛力。

We believe we have worked through most of the one-time wave of early adopters and EAP patients and expect to receive 225 cumulative start forms or more by the end of this year.

我們相信，我們已經處理了大部分早期採用者和 EAP 患者的一次性需求，預計到今年年底將收到 225 份或更多的累積啟動表格。

Looking ahead, we are confident in the long term growth potential of EMPAVELI as awareness deepens and patient access continues to expand. Moving on to SYFOVRE, we are encouraged to see continued market leadership with a total estimated injection growth of 4% during the quarter, in line with our expectations.

展望未來，隨著人們對 EMPAVELI 的認識不斷加深，以及病患就醫管道的不斷擴大，我們對 EMPAVELI 的長期成長潛力充滿信心。接下來是 SYFOVRE，我們很高興地看到其繼續保持市場領先地位，本季總注入量預計將成長 4%，與我們的預期一致。

SYFOVRE maintains its leading position accounting for an estimated 52% of new patient starts during the third quarter and more than 60% of the overall market. As commercialization matures, we’ve moved past the early adopter phase and expect steady measured injection growth for the near term.

SYFOVRE 保持領先地位，在第三季新患者啟動中約佔 52%，在整個市場中佔比超過 60%。隨著商業化的成熟，我們已經度過了早期採用者階段，預計在短期內註射量將穩定成長。

Importantly, we believe that the long-term market opportunity remains significant with blockbuster potential. Today, only about 10% of patients who are diagnosed with GA are being treated, and specifically for retina specialists, on average, just one in five patients with GA in their practice are treated with a complement inhibitor.

重要的是，我們認為長期市場機會依然巨大，具有巨大的爆款潛力。如今，只有約 10% 的 GA 患者接受治療，特別是對於視網膜專家而言，平均而言，他們診治的 GA 患者中只有五分之一接受補體抑制劑治療。

This leaves substantial room for growth by expanding the total number of prescribers and by increasing adoption within existing practices.

這為擴大處方醫生總數和提高現有診所的採納率留下了很大的成長空間。

To drive this opportunity forward, we are focusing on disease awareness and education, laying the groundwork for the next wave of growth through initiatives that include engaging with early career retina specialists who see a disproportionate number of new patients, enhancing education around the importance of early intervention and maintaining patients on treatment, and refining our messaging to better equip field teams in their outreach and discussions.

為了推動這一機遇，我們正專注於提高人們對疾病的認識和教育，透過一系列舉措為下一波增長奠定基礎，這些舉措包括：與接診大量新患者的早期職業視網膜專家合作；加強對早期幹預和維持患者治療重要性的教育；以及改進我們的宣傳信息，以便更好地幫助一線團隊開展外聯和討論。

I will now hand the call over to Dr. Caroline Baumal to share additional color on these initiatives and provide an update on our pipeline. Caroline.

現在我將把電話交給卡羅琳·鮑馬爾博士，讓她詳細介紹這些舉措並介紹我們的最新進展。卡洛琳。

Thanks David, let me start with SYFOVRE and geographic atrophy. As the only approved drug that binds to C3, the central protein of the complement cascade, SYFOVRE potently inhibits the damaging downstream effects of complement overactivation, forming the basis of its strong clinical profile.

謝謝大衛，讓我先從SYFOVRE和地圖狀萎縮說起。SYFOVRE 是唯一獲準與補體連鎖反應的核心蛋白 C3 結合的藥物，它能有效抑制補體過度活化的有害下游效應，從而奠定了其強大的臨床療效。

Patients with GA are on an irreversible path to blindness. As Cedric and David mentioned, there is ample opportunity to advance the understanding of GA within the treatment community and to instill the urgency to treat patients early to save retina tissue.

患有GA的患者正走上一條不可逆轉的失明之路。正如 Cedric 和 David 所提到的，治療界有很多機會可以增進對 GA 的了解，並灌輸儘早治療患者以挽救視網膜組織的緊迫性。

To support this, we are developing artificial intelligence tools that will help physicians gain a better understanding of what GA patients experience as well as the benefit of treatment with SYFOVRE. We are also working to provide more convenient administration through the development of a pre-filled syringe.

為了支持這一點，我們正在開發人工智慧工具，以幫助醫生更好地了解全身麻醉患者的經驗以及使用 SYFOVRE 治療的好處。我們也致力於透過開發預充式註射器來提供更方便的給藥方式。

We believe that both of these key initiatives will broaden the prescriber universe within the overall GA market and drive higher utilization of SYFOVRE over time. Turning now to EMPAVELI in C3G and primary ICMPGN.

我們相信，這兩項關鍵措施將擴大整個全身麻醉市場的處方醫生範圍，並隨著時間的推移推動 SYFOVRE 的更高利用率。現在轉向 C3G 中的 EMPAVELI 和主要 ICMPGN。

The treatment community’s response to the recent approval has been incredibly positive and we are confident that it will be the preferred treatment option for these patients.

治療界對此次核准的反應非常積極，我們相信它將成為這些患者的首選治療方案。

We’re excited to share seven abstracts at next week’s American Society of Nephrology meeting, further demonstrating EMPAVELI’s profound and durable benefits and underscoring our commitment to the rare nephrology community.

我們很高興能在下週的美國腎臟病學會會議上分享七篇摘要，進一步證明 EMPAVELI 的深遠而持久的益處，並強調我們對罕見腎臟病界的承諾。

Building on this momentum, we are expanding EMPAVELI’s development into two other rare kidney diseases. Primary focal segmental glomerulosclerosis, or FSGS, and delayed graft function, or DGF.

以此動能為動力，我們將 EMPAVELI 的研發擴展到另外兩種罕見的腎臟疾病領域。原發性局部性節段性腎絲球硬化症（FSGS）和移植腎功能延遲恢復（DGF）。

Similar to C3G, FSGS is a rare kidney disease that progresses to kidney failure within 5 to 10 years for about half of patients. DGF is a complication in kidney transplantation that negatively affects the long-term survival of the kidney and the overall patient outcomes.

與 C3G 類似，FSGS 是一種罕見的腎臟疾病，約有一半的患者會在 5 到 10 年內發展為腎衰竭。DGF是腎移植術後的一種併發症，會對腎臟的長期存活和患者的整體預後產生負面影響。

The complement pathway plays a significant role in both diseases and there are currently no FDA approved therapies for either. We are well underway with our planning activities and expect to initiate pivotal trials in FSGS and DGF by the end of the year.

補體途徑在這兩種疾病中都起著重要作用，目前尚無FDA核准的治療方法。我們的規劃活動進展順利，預計今年底前啟動 FSGS 和 DGF 的關鍵性試驗。

With that, I’ll now turn the call over to Tim for an update of the financials.

接下來，我會把電話交給提姆，讓他回報一下財務狀況。

Thank you, Caroline. Total revenue for the third quarter was $459 million, including the $275 million upfront payment from Sobi in connection with the EMPAVELI royalty purchase agreement. SYFOVRE net product revenue for the quarter was $151 million.

謝謝你，卡洛琳。第三季總收入為 4.59 億美元，其中包括 Sobi 根據 EMPAVELI 特許權使用費購買協議支付的 2.75 億美元預付款。SYFOVRE 本季淨產品收入為 1.51 億美元。

We delivered approximately 101,000 doses of SYFOVRE in the quarter, including 86,000 commercial doses and 15,000 free goods doses. In line with our expectations, we saw 4% sequential growth in overall total injection demand during the third quarter, driven predominantly by free goods.

本季度我們交付了約 101,000 劑 SYFOVRE，其中包括 86,000 劑商業劑量和 15,000 劑免費贈品劑量。正如我們預期的那樣，第三季整體注射需求較上季成長 4%，主要受贈品推動。

While we are encouraged by the continued growth in total injections as a leading indicator of demand, we did see an approximate $15 million headwind to our reported revenue due to the elevated use of free goods, which was slightly higher than our expectations.

儘管我們對總注入量持續增長（這是需求的領先指標）感到鼓舞，但由於免費商品使用量增加，我們報告的收入出現了約 1500 萬美元的不利影響，這略高於我們的預期。

For the first three quarters of the year. We estimate that free drug has been a nearly $40 million headwind to SYFOVRE revenue. Looking ahead to the fourth quarter, we continue to expect modest SYFOVRE total injection growth within the low to mid-single digit range.

今年前三個季度。我們估計，免費藥物對 SYFOVRE 的收入造成了近 4,000 萬美元的損失。展望第四季度，我們繼續預期 SYFOVRE 總注入量將保持溫和成長，增幅在個位數低到中段範圍內。

Turning to gross to net dynamics, adjustments during the third quarter for SYFOVRE remained within the low to mid 20% range, consistent with our guidance through 2025. As we move into Q4, we expect gross to net to trend slightly above the prior range.

從毛利到淨利的動態變化來看，SYFOVRE 第三季度的調整幅度保持在 20% 左右的低位，與我們到 2025 年的指導一致。進入第四季度，我們預計毛利率將略高於先前的水平。

This reflects the normal stepwise pattern of gross to net over time, with modest degradation and some quarter to quarter movement that’s typical in the buy and build market.

這反映了毛利隨時間推移逐步變為淨利潤的正常模式，伴隨著適度的下降和一些季度間的波動，這在收購和建設市場中很常見。

Importantly, this reflects expected dynamics rather than a structural shift, and we remain confident in our pricing and access position heading into 2026. From a channel perspective, we anticipate a modest channel build during the fourth quarter, consistent with seasonal patterns expected at year end.

重要的是，這反映的是預期的動態變化，而不是結構性轉變，我們對2026年的定價和進入地位仍然充滿信心。從通路角度來看，我們預計第四季度通路建設將保持適度成長，這與年底的季節性趨勢相符。

That said, we continue to target stable inventory levels quarter-over-quarter and will provide further commentary during our year end update. Taken together, our current view is that the fourth quarter SYFOVRE revenue will be broadly in line with what we recorded in the third quarter.

儘管如此，我們仍將致力於維持季度間穩定的庫存水平，並將在年終更新報告中提供進一步的評論。綜合來看，我們目前的看法是，SYFOVRE 第四季的營收將與第三季的營收大致持平。

Looking beyond these short term dynamics, as Cedric and Caroline mentioned, we have several compelling opportunities that are largely within our control to reinvigorate SYFOVRE’s growth over the next 12 to 18 months.

拋開這些短期動態不談，正如 Cedric 和 Caroline 所提到的，我們有幾個令人信服的機會，這些機會在很大程度上掌握在我們自己手中，可以在未來 12 到 18 個月內重振 SYFOVRE 的增長。

We remain confident in the meaningful long term potential of SYFOVRE and look forward to updating you on our progress in bringing these initiatives to fruition. Moving now to EMPAVELI, total net product revenue across indications, which includes PNH, C3G, and primary ICMPGN, was $27 million during the third quarter.

我們對 SYFOVRE 的長期發展潛力充滿信心，並期待向您報告我們在實現這些計劃方面取得的進展。現在來看看 EMPAVELI，第三季其所有適應症（包括 PNH、C3G 和原發性 ICMPGN）的總淨產品收入為 2,700 萬美元。

We believe we are now through most of the initial wave of early adopters and, looking ahead, we expect the nephrology opportunity to normalize into a gradual ramp.

我們相信，目前大部分早期採用者已經度過了最初的浪潮，展望未來，我們預計腎臟病學領域的機會將逐漸趨於正常化。

Turning to expenses, we’ve maintained a highly disciplined approach to cost management, prioritizing the commercialization of SYFOVRE and EMPAVELI while continuing to fund the next phase of innovation.

在支出方面，我們一直保持著高度自律的成本管理方法，優先考慮 SYFOVRE 和 EMPAVELI 的商業化，同時繼續為下一階段的創新提供資金。

For Apellis Pharmaceuticals, operating expenses were $235 million in the third quarter, down from $244 million for the same quarter last year. We continue to expect our full year operating expenses to be in line with the OpEx levels we saw in 2024.

Apellis Pharmaceuticals 第三季的營運支出為 2.35 億美元，低於去年同期的 2.44 億美元。我們仍然預計全年營運支出將與 2024 年的營運支出水準保持一致。

We ended the quarter with $475 million in cash and cash equivalents, supported by the $275 million upfront from our Sobi royalty transaction this quarter. Our strong cash position gave us the flexibility to discontinue factoring during the quarter.

本季末，我們持有現金及現金等價物 4.75 億美元，其中 2.75 億美元來自本季度 Sobi 特許權交易的預付款。我們雄厚的現金儲備使我們能夠靈活地在本季度停止保理業務。

As a result, we now carry the incremental balance in receivables on our balance sheet rather than in cash, and we expect to realize cost savings of approximately $5 million on a go forward annual basis. We continue to expect our cash position will be sufficient to fund the business to sustainable profitability.

因此，我們現在將新增應收帳款餘額記入資產負債表，而不是記入現金，預計未來每年可節省約 500 萬美元的成本。我們仍然預計，我們的現金儲備足以支持企業實現永續獲利。

With that, I will now turn the call back over to Cedric. Cedric, thank you, Tim.

接下來，我將把電話轉回給塞德里克。塞德里克，謝謝你，提姆。

We have made important progress in 2025 to date. We achieved our third approval in just four years, bringing a first-in-class C3 treatment option to people living with C3G and primary ICMPGN, many of whom had previously been living without any available options.

截至目前，我們在2025年取得了重要進展。我們在短短四年內獲得了第三個批准，為患有 C3G 和原發性 ICMPGN 的患者帶來了首創的 C3 治療選擇，其中許多患者以前沒有任何可用的治療方案。

Early feedback across the patient and nephrology communities has been enthusiastic, reflecting recognition of EMPAVELI’s compelling efficacy profile and its value as a new treatment option.

患者和腎臟病學界的早期回饋非常熱情，這反映出人們對 EMPAVELI 的顯著療效及其作為新治療選擇的價值的認可。

Additionally, SYFOVRE continues its market leadership and delivers a durable, meaningful revenue stream with opportunities for renewed growth over the long term. Combined with the cash from our Sobi deal in June, we have made steady progress on our path towards profitability.

此外，SYFOVRE 繼續保持市場領先地位，並提供持久、有意義的收入來源，且具有長期持續成長的機會。加上六月從 Sobi 交易中獲得的現金，我們在實現盈利的道路上取得了穩步進展。

We look forward to building off the solid foundation we have laid for ourselves in the fourth quarter and into 2026. With that, I’ll turn the call over to the operator for questions and answers.

我們期待在第四季以及2026年，在我們為自己打下的堅實基礎上繼續發展。這樣，我就把電話轉交給接線生，由他們來回答問題。

(Operator Instructions) John Miller, Evercore ISI.

（操作說明）John Miller，Evercore ISI。

Hi guys. Thanks so much for taking my question and congrats on the progress and a strong C3G launch. I guess I’ll ask my question about that. Do you still expect past this first? Bolus of patients that you were talking about?

嗨，大家好。非常感謝您回答我的問題，祝賀您的進展以及C3G的成功發布。我想我還是問問關於這個問題。你仍然期待著超越這一關嗎？您剛才提到的病人推注？

That kidney is going to be a distributed or slow indication set of indications to penetrate? I think this has been your commentary and the competitor’s commentary in the past.

此腎臟的滲透性是分散的還是緩慢的？我認為這過去一直是你和競爭對手的評論。

Do you expect that to continue or is your strong penetration into these top practices indicative that the launch could be more rapid than people expect?

您預計這種情況會持續下去嗎？還是說您對這些頂級實踐的深入滲透表明，產品的推出速度可能會比人們預期的更快？

Thank you, John. Great to hear you. I will hand that question over to David.

謝謝你，約翰。很高興聽到這個消息。我會把這個問題交給大衛問。

Hey John, thanks for the question. Appreciate it. First of all, we’re really excited about where we are with the launch for EMPAVELI and C3G and primary ICMPGN. The team has done a great job.

嘿，約翰，謝謝你的提問。謝謝。首先，我們對 EMPAVELI 和 C3G 以及主要 ICMPGN 的發布進展感到非常興奮。團隊做得非常出色。

I do suspect, you know, as we get through the end of this year that the bullets that we had talked about will be through that and you’ll see steady, consistent growth going into next year. That’s our expectation.

我懷疑，你知道，隨著今年年底的到來，我們之前討論過的那些問題將會得到解決，你會看到明年穩定、持續的成長。這是我們的預期。

Anupal Rama, JPMorgan.

Anupal Rama，摩根大通。

Hey guys, thanks so much for taking the question. Just a quick one on SYFOVRE on sampling, I think samples are on the higher end of this 10% to 15% range that we’ve all previously talked about. Should we expect this to now be? More stabilized, or is there a chance that this continues to creep up as you expand the market? Thanks so much.

各位，非常感謝你們回答這個問題。關於 SYFOVRE 的抽樣，我簡單說一下，我認為抽樣率處於我們之前討論過的 10% 到 15% 範圍的較高水平。我們現在應該期待這種情況發生嗎？價格會更加穩定嗎？還是隨著市場擴張，價格有可能會繼續緩慢上漲？非常感謝。

Hey Anupam, great hearing you again. I’m going to hand it over to David.

嗨，Anupam，很高興再次聽到你的聲音。我要把它交給大衛。

Hey Anupam, thanks for the question. A couple things real quick. We definitely review where we are with samples in the PAP program or free goods consistently to make sure the programs are being utilized the way that we want them to be.

嗨，Anupam，謝謝你的提問。有幾件事要趕緊說。我們一定會定期審查 PAP 計劃中的樣品或免費商品的發放情況，以確保這些計劃能夠按照我們想要的方式得到利用。

Also, we are, as you know, as a company, very in tune to making sure patients have access to products. As things continue to grow, we’ll have programs available for patients.

此外，如您所知，我們公司非常重視確保患者能夠獲得產品。隨著業務的不斷發展，我們將為患者提供相應的項目。

Steve Seedhouse, Cantor.

史蒂夫·西德豪斯，領唱。

Good morning. Thanks for taking the questions. Just wanted to ask a few specifics on C3G. First, can you break out, just of the 150 odd patients, how many are C3G? How many are ICMPGN? Pre versus post-transplant, adult versus adolescent?

早安.謝謝您回答問題。我想問一下關於C3G的一些具體問題。首先，請問在這 150 多名患者中，有多少是 C3G 患者？ICMPGN有幾個？移植前與移植後，成人與青少年？

Also, do you know if anyone has switched from Fabhalta to EMPAVELI? Do you have a sense of your market share in C3G? Just how many patients are on Fabhalta vs EMPAVELI then?

另外，請問有人從 Fabhalta 轉到 EMPAVELI 嗎？您對自己在C3G市場的佔有率有什麼了解嗎？那麼，究竟有多少病患在使用Fabhalta，又有多少病患在使用EMPAVELI呢？

Thank you, Steve. Great questions. This is David. You’re right. We have 152 start forms. Roughly 50 of those came through our EAP program. Consistently to label, we’ve seen start forms come through across the broad label, which is positive and for both indications.

謝謝你，史蒂夫。問得好。這是大衛。你說得對。我們有152份入學申請表。其中大約有 50 人是透過我們的員工協助方案 (EAP) 獲得的。根據標籤所示，我們已經看到各種起始形式出現在廣泛的標籤中，這對兩種適應症來說都是正面的。

We are seeing Fab Alta switches as a result of the information we’ve gotten from physicians, as a result of our efficacy, in some cases some tolerability, and the ability for them to dose twice weekly with EMPAVELI versus twice daily with the competitive product.

由於我們從醫生那裡獲得的信息，以及我們的療效、在某些情況下的耐受性，以及他們能夠每週服用兩次 EMPAVELI 而不是每天服用兩次競爭產品，我們看到 Fab Alta 的轉換。

Yugal Nochemowitz, Citigroup. Check to see if you’re on mute. Yugal.

Yugal Nochemowitz，花旗集團。檢查一下你是否處於靜音狀態。尤加爾。

Sorry about that. Hi, can you hear me? Yes, this is also. Thanks for taking the question. This is also a specific question on the launch, I think. David, you mentioned that 50 of the patients are in the process of converting to commercial drug, these are the ones rolling over from the clinical trials.

抱歉。你好，你聽得到我說話嗎？是的，這也是。感謝您回答這個問題。我認為這也是一個關於產品發布的具體問題。大衛，你提到有 50 名患者正在轉用商業藥物，這些患者是從臨床試驗中轉過來的。

It’s just not clear. Are those actually on drug at this point? Are they still in process? The incremental other 102. Could you just comment on what fraction of those have started EMPAVELI and approximately how long they’ve been on the drug? Since the end of July.

這一點尚不清楚。他們現在真的在吸毒嗎？它們還在處理中嗎？增量其他 102。能否簡要說明一下，其中有多少人開始服用 EMPAVELI，以及他們服用該藥物的大約時間？自七月底以來。

Thank you, Yvette. Thank you for the question. You’re correct. There’s roughly 50 patients on EAP. Our goal is to make sure all of them make it to commercial products by the end of the year. Of the rest that have come in for new start forms, we are still working through the process with many of them.

謝謝你，伊薇特。謝謝你的提問。你說得對。大約有 50 名患者正在接受 EAP 計劃。我們的目標是確保所有這些成果都能在年底前轉化為商業產品。對於其他前來申請新員工入職表格的人，我們仍在與他們中的許多人一起辦理相關手續。

Remember, it takes four to six weeks for those patients to typically get from start to finish and get product. That process is also being worked up as we move through the end of the year.

請記住，這些患者通常需要四到六週的時間才能完成整個治療過程並獲得產品。隨著年底臨近，我們也不斷改善這項流程。

Okay, thank you.

好的，謝謝。

Salveen Richter, Goldman Sachs.

薩爾文·里克特，高盛。

Hi, good morning. Thanks for taking our question. This is Elizabeth on for Salveen. Just one from us on that four to six week time frame from start to finish of getting product of EMPAVELI to treatment.

您好，早安。感謝您回答我們的問題。這是伊莉莎白為薩爾文所做的報道。我們僅就從開始到完成 EMPAVELI 產品治療的四到六週時間提供一點資訊。

When do you think we could start to see kind of an acceleration there? What do you think that could normalize as? Thank you.

你認為我們什麼時候才能看到這方面的加速發展？你認為這種情況最終會變成什麼樣子？謝謝。

Thank you very much, Elizabeth. A couple things to keep in mind that’s typical for most rare disease launches, in particular where you have a REMS and vaccination and a start form that has to go in from a physician.

非常感謝你，伊麗莎白。有幾件事需要記住，這在大多數罕見疾病藥物上市時都很常見，特別是需要製定風險評估和緩解策略 (REMS)、接種疫苗以及填寫醫生開立的啟動表格。

The other thing that we’re continuing to work through is the policies that are being written at the payer, which also takes some work early on in the process to make sure that transition from four to six weeks comes down to less than that period. We’re working through that now and we’ll have details as we move forward.

我們正在繼續研究的另一件事是付款方正在製定的政策，這也需要在流程早期階段做一些工作，以確保從四周到六週的過渡期縮短到更短的時間內。我們正在處理此事，後續將有更多細節公佈。

Akash Tawiri, Jefferies.

阿卡什‧塔維裡，傑富瑞集團。

Hi, this is Kathy on for Akash. SYFOVRE revenue stayed flat at $151 million quarter-over-quarter and injection growth was 4%. Do you see this as the floor for SYFOVRE before other components like long-term efficacy data or PFF come into play?

大家好，我是凱西，替阿卡什為您報道。SYFOVRE 營收環比持平，為 1.51 億美元，注射量成長 4%。您認為這是 SYFOVRE 的底線嗎？在長期療效數據或 PFF 等其他因素發揮作用之前，這是否是底線？

When can we assume a return to growth for SYFOVRE, or do you think it stays at this level given you’re not assuming patient funding gets resolved near term?

我們什麼時候才能認為SYFOVRE會恢復成長？或者考慮到您認為患者資金問題短期內無法解決，您認為它會保持目前的水平嗎？

Hi. Thank you, Kathy. This is Tim. From a growth perspective this quarter, we feel very good about the underlying demand growth of 4%. As we mentioned in the prepared remarks, the bulk of that increase in demand came from.

你好。謝謝你，凱西。這是蒂姆。從本季的成長角度來看，我們對 4% 的潛在需求成長感到非常樂觀。正如我們在準備好的演講稿中所提到的，需求成長的大部分來自。

That was a headwind that we’ve been experiencing for the last three quarters or so, and the headwind has amounted to approximately $40 million over the course of the last three quarters.

這是我們在過去三個季度左右一直面臨的不利因素，在過去三個季度中，這種不利因素造成的損失約為 4000 萬美元。

Over the long term, beyond these short term dynamics, as Cedric and Caroline mentioned in their prepared remarks, we have a lot of compelling opportunities to reinvigorate SYFOVRE’s growth.

從長遠來看，除了這些短期動態之外，正如 Cedric 和 Caroline 在他們準備好的發言稿中提到的那樣，我們有很多令人信服的機會來重振 SYFOVRE 的成長。

Those include the pre-filled syringe among others, and we’ll get more visibility to you on those at the beginning of the year.

其中包括預充式註射器等，我們將在年初向您詳細介紹這些產品。

Colleen Cussy, Baird.

科琳·庫西，貝爾德。

Great. Good morning. Congrats on the progress and thanks for taking our questions. You spoke to some learnings of prescribers habits in C3G and ICMPGN at this early stage of launch. Can you elaborate on that a little bit and what the implications are for the launch? Thank you.

偉大的。早安.恭喜你們取得進展，謝謝你們回答我們的問題。在 C3G 和 ICMPGN 上市初期，您談到了處方醫生的一些習慣。您能否詳細說明一下，以及這對產品發表會有何影響？謝謝。

Yeah, this is David. Thank you. I’ll hand it over to Caroline too if there’s any comments on the medical side.

是的，這是大衛。謝謝。如果對醫療方面有任何意見，我也會把它交給卡羅琳。

I can tell you that we’ve been very pleased with the fact that we have a very open label, and we’ve seen patients come through that are aligned to all of the indications for both indications in the label, which is very positive.

我可以告訴大家，我們對我們擁有非常開放的標籤感到非常滿意，我們看到許多患者符合標籤上列出的所有適應症，這非常積極。

What we’re learning now is making sure that we get through the process in education with the top 20 accounts and also make sure that we are continuing to canvass and have the conversations with all of the accounts beyond that. It’s a new indication and a new product for folks, and they’re learning how to adjust to it. We’re excited about the launch so far.

我們現在學到的是，確保我們與前 20 位客戶順利完成教育流程，同時也要確保我們繼續與所有其他客戶進行溝通和對話。對人們來說，這是一種新的適應症和新產品，他們正在學習如何適應。我們對目前的發布情況感到非常興奮。

And what we’ve been hearing from physicians is that they are excited about our data, the robustness of it, the reduction in proteinuria, and our 52 week results will be presented at the American Society of Nephrology, amongst other abstracts that we have highlighting the reductions in proteinuria.

我們從醫生那裡聽到的是，他們對我們的數據、數據的穩健性、蛋白尿的減少感到興奮，我們的 52 週結果將在美國腎臟病學會上公佈，此外，我們還有其他摘要也重點介紹了蛋白尿的減少。

Maybe one last thing here from me, this is Cedric. It’s been really gratifying to see how well we kind of were prepared and understand the landscape.

最後再補充一點，這位是賽德里克。看到我們對當地情況準備得如此充分，了解得如此透徹，真是令人欣慰。

We’re very happy with the demographics that we have calculated, the ramp forecast we’ve created. It’s gratifying to see the results from clinical trials translate in the real world the way it does.

我們對我們計算出的人口統計和我們制定的成長預測非常滿意。看到臨床試驗的結果能夠以這種方式轉化為現實世界的成果，真是令人欣慰。

Ellen Hortz, TD Cowen.

艾倫·霍茨，TD Cowen。

Hi guys. I’m on for Phil this morning. Congrats on the quarter. Just one question from us on SYFOVRE. Has there been any progress with the Good Days copay assistance charity? Is there any visibility on when and if it can be funded to assist GA patients? Thanks.

嗨，大家好。我今天早上替菲爾主持節目。恭喜你本季取得佳績。我們只有一個關於SYFOVRE的問題。Good Days共付額援助慈善機構的進展如何？目前是否有任何跡象表明何時以及是否可以獲得資金來幫助GA患者？謝謝。

Hi, thank you for the question. This is Tim. There has been some progress in the sense that we understand that the largest of these groups is open for existing patients, but unfortunately not for new patients.

您好，感謝您的提問。這是蒂姆。從某種意義上說，已經取得了一些進展，我們了解到這些群體中最大的一個群體對現有患者開放，但不幸的是，它不接受新患者。

You can check that on the website. As far as we know, and as far as our guidance that we gave in terms of this quarter, we don’t expect anything to change with respect to the patient assistance organizations.

您可以在網站上查看。據我們所知，也根據我們本季給予的指導意見，我們預期患者援助組織方面不會有任何變化。

Jade Moman, Stifel.

Jade Moman，Stifel。

Hi, this is Dyad on for Annabelle. Two questions. The first one is for C3 glomerulopathy and ICMPGN. For, that one-third shared market with that. How do you expect prescriber, how do you expect that market to bifurcate? What type of patients would our physicians, starting SYFOVRE in and what type of patients would be preferred for EMPAVELI?

您好，這裡是Dyad，為您帶來Annabelle的節目。兩個問題。第一種是針對 C3 腎絲球病變和 ICMPGN 的。因為，那三分之一的市佔率與它共享。您認為處方醫生群體，以及這個市場將如何分化？我們的醫師會為哪些類型的病患開始使用 SYFOVRE，以及會為哪些類型的病患選擇 EMPAVELI？

Thank you for that question. This is Cedric. I think that the efficacy profile that was established in the Valiant trial across all of the patient populations that we have tested and that we’ve spoken about, that is really what stands out there.

謝謝你的提問。這是塞德里克。我認為，Valiant 試驗在所有我們測試過和討論過的患者群體中確立的療效特徵，才是真正突出的地方。

This is something that we believe is going to be really important in a segment of physicians that cares deeply about differentiated efficacy. I think we have, with the broad label that we have, an opportunity to really kind of go through segment by segment.

我們認為，對於那些非常重視差異化療效的醫師群來說，這一點將非常重要。我認為，憑藉我們擁有的這個廣泛的標籤，我們有機會真正逐一細分市場進行分析。

We’ve talked before about the fact that post-transplant patients are a particularly interesting group. For obvious reasons, most transplanted patients will relapse. It takes a little bit of time to get on protocols, et cetera, but that’s a very exciting group of patients that we’re looking forward to being able to help.

我們之前討論過，移植後患者是一個特別有趣的族群。顯而易見，大多數移植患者都會復發。制定治療方案等等需要一些時間，但這是一群非常令人興奮的患者，我們期待能夠幫助他們。

Of course, patients that are advanced at risk of going into end stage renal disease. The fact that we have pediatrics in our label as well and be able to offer something to patients 12 years to 18 years is very attractive to the nephrology community as well.

當然，指的是那些病情發展到晚期，有發展為末期腎病風險的患者。我們的產品標籤中包含兒科，能夠為 12 歲至 18 歲的患者提供產品，這對腎臟病學界來說也很有吸引力。

Thinking about one more on SYFOVRE. It’s been on the GA market for a couple of years now. You go by the patterns in wet AMD, you might start to see patients drop off at this stage. What are you seeing as far as persistence on treatment.

正在考慮在 SYFOVRE 上再加一個。它已經在通用航空市場上銷售好幾年了。根據濕性老年黃斑部病變的模式，你可能會發現患者在這個階段開始減少。就治療的持續性而言，您觀察到什麼情況？

Complaints?

投訴？

Thank you for the question. With our every other month dosing, which is very in line with anti-VEGF treatments, we’re hearing from our physicians that patients are being compliant with treatment, and there will be some long-term data coming out from our open-label extension next year.

謝謝你的提問。我們採用每隔一個月給藥一次的方案，這與抗 VEGF 治療非常一致。我們從醫生那裡了解到，患者對治療的依從性很好，明年我們將公佈一些來自開放標籤擴展研究的長期數據。

Lachlan Hanbury-Brown, William Blair.

拉特蘭·漢伯里-布朗，威廉·布萊爾。

Hey, thanks for the question. I guess one on SYFOVRE, I noticed the new patient share ticked down a few points this quarter. I was wondering if there’s any underlying dynamic that changed in the quarter that drove that, or is that just sort of noise fluctuating a few percentage points and it’s kind of reached a point of stability? Yeah.

嘿，謝謝你的提問。我猜是SYFOVRE的其中一例，我注意到本季新病患份額下降了幾個百分點。我想知道本季度是否有任何潛在的動態變化導致了這種情況，或者這只是幾個百分點的波動，現在已經趨於穩定？是的。

Thanks for the question. This is David. First of all, we’re very confident in where we are competitively. Just a reminder, we’re 52% on MBRXS and over 60%. We continue to hold and have held for TRXS.

謝謝你的提問。這是大衛。首先，我們對自身的競爭地位非常有信心。提醒一下，我們在 MBRXS 上的得分是 52%，其他方面超過 60%。我們一直持有TRXS股票，現在仍然持有。

You’re exactly right. What you’ll see sometimes is a fluctuation in MBRXS up or down. We’re confident in the consistent numbers that we’ve seen in reporting today.

你說得完全正確。你有時會看到 MBRXS 出現上下波動。我們對今天報告中呈現的穩定數據充滿信心。

Derek Achilla, Wells Fargo.

德里克·阿奇拉，富國銀行。

Hey, good morning and thanks for taking the questions. Maybe just two from us. First on SYFOVRE, I guess how do you think about pre-filled syringe, the checks that we’ve done on that, you know, it seems like docs would be pretty enthusiastic.

嗨，早上好，謝謝你回答這些問題。或許我們只有兩個。首先在 SYFOVRE 上，我想問大家對預充式註射器的看法，我們對此進行了一些檢查，你知道，醫生們似乎對此非常熱情。

When could that be made available and how do you think that changes the growth trajectory? Is it more shifting share or expanding the market? I didn’t know if I joined late. In terms of initial start forms, any comments on trends post the quarter? Thanks.

何時才能實現？您認為這將如何改變成長軌跡？是市佔率轉移還是市場擴張？我不知道我是否加入得太晚。就初始啟動形式而言，對本季後的趨勢有何評論？謝謝。

Hi Derek, great hearing you. Thank you so much. The pre-filled syringe is something that is really important in the context of the retina physicians. It improves the flow in their practices, makes it easier to handle the workload.

嗨，德里克，很高興收到你的消息。太感謝了。預充式註射器對於視網膜醫生來說非常重要。它改善了他們的工作流程，使他們更容易處理工作量。

We have been working on a pre-filled syringe. That pre-filled syringe is currently being tested in the clinic.

我們一直在研發預充式註射器。目前正在診所進行預充式註射器的測試。

We’re not guiding on timelines to when it will actually be available for competitive reasons, but the quality of the syringe that we have has met the high expectations that we’ve had and super excited about going to market with that.

出於競爭原因，我們不打算透露具體的上市時間，但我們生產的注射器品質達到了我們一直以來的高期望值，我們非常興奮能將它推向市場。

I think it’s also worth mentioning here that within the type of physicians that treat patients with geographic atrophy, there are a lot of physicians that occasionally use SYFOVRE, not on a regular basis.

我覺得這裡也值得一提的是，在治療地圖狀萎縮症患者的醫生中，有很多醫生偶爾會使用 SYFOVRE，而不是定期使用。

Those are physicians that I suspect are going to be excited about kind of moving towards a more routine involvement of GA patients into their practices.

我懷疑這些醫生會很高興能夠將全身麻醉患者更常規地納入他們的診療實踐中。

Even for those physicians that have not yet embraced SYFOVRE as a treatment for their patients, we know that many of them are waiting for the pre-filled syringe to start treating this terrible disease. I don’t know, Caroline, if you want to add something.

即使對於那些尚未接受 SYFOVRE 作為患者治療方案的醫生來說，我們也知道他們中的許多人都在等待預充式註射器來開始治療這種可怕的疾病。卡洛琳，我不知道你是否想補充什麼。

As a retina physician, I will say that it really increases convenience, consistency, and safety to have a pre-filled syringe. The requirements are very high for quality, and I’m really, really pleased with where we’re headed with this. There was another part to the question, part one this quarter.

身為視網膜科醫生，我認為使用預充式註射器確實能提高便利性、一致性和安全性。對品質的要求非常高，我對我們目前的進展感到非常非常滿意。這個問題還有另一部分，這是本季的第一部分。

Derek, just the last part of that question. Thank you again. From a launch perspective, obviously we feel great beyond the guidance that we gave in terms of the start forms for the prepared remarks. I don’t think we’re guiding any further than that. We’re happy to look forward to giving you an update at the year end. Paul.

德瑞克，就回答你問題的最後一部分。再次感謝。從發布會的角度來看，我們顯然感覺非常好，遠遠超出了我們之前在準備發言稿的開場白方面給出的指導。我認為我們不會再做任何進一步的指導了。我們很高興能在年底前向您報告最新情況。保羅。

Byron Amin, Piper Sandler.

拜倫·阿明，派珀·桑德勒。

Yeah. Hi guys. Thanks for taking my questions this morning. Apellis just revised SYFOVRE guidance downward by $200 million. They’re clearly seeing headwinds in GA market growth.

是的。嗨，大家好。謝謝您今天上午回答我的問題。Apellis剛剛將SYFOVRE的業績預期下調了2億美元。他們顯然看到了通用航空市場成長的逆風。

Given that data point and your low to mid-single injection growth that you project, do you feel it’s due to undertreatment and what shifts that dynamic with retina physicians?

鑑於該數據點以及您預測的單次注射增長幅度較低至中等，您認為這是由於治療不足造成的嗎？視網膜醫師的這種看法又是如何改變的呢？

I’ll just confirm what you’re saying, which is that we do see a significant headwind for these patients who are trying to get treated and want to get treated but can’t afford it. It’s had a huge impact on the market in general.

我只是想證實你所說的，那就是我們確實看到，對於那些想要接受治療但又負擔不起治療費用的患者來說，存在著很大的阻力。它對整個市場產生了巨大影響。

At least our discussions with retinal specialists suggest that many of them are not treating GA patients or not even having the conversation they should be having with GA patients because this has created a logistical as well as a financial headwind. I hope that answers your question.

至少我們與視網膜專家的討論表明，他們中的許多人沒有治療 GA 患者，甚至沒有與 GA 患者進行他們應該進行的對話，因為這造成了後勤和經濟上的不利影響。希望我的回答能解答你的疑問。

I think what can shift the dynamics with physicians also are multiple things that we’re working on at Apellis. We’re the science company. We have robust data. We’re working on educating physicians using artificial intelligence, which they can also use for patients.

我認為，能夠改變與醫生之間關係的許多因素，也是我們在 Apellis 正在努力的方向。我們是一家科學公司。我們擁有可靠的數據。我們正在努力利用人工智慧對醫生進行培訓，以便他們也能將人工智慧應用於患者。

We’re working on a pre-filled syringe and we have multiple new things coming forward to impact physicians and patients.

我們正在研發預充式註射器，還有多項新技術即將推出，這些新技術將對醫生和病人產生影響。

Judah Frommer, Morgan Stanley.

猶大‧弗洛默，摩根士丹利。

Hi guys. Thanks for taking the questions. Maybe just a couple follow ups, I guess. On patient start forms for C3G and ICMPGN, can you comment on just how they came in versus internal expectations? Sounds like they came in reasonably well.

嗨，大家好。謝謝您回答問題。或許只需要幾個後續問題吧。關於 C3G 和 ICMPGN 的病患入院表格，您能否評估一下實際結果與內部預期之間的差異？聽起來他們表現得還不錯。

On just the sampling for SYFOVRE, any commentary you can make on how much of that is self-driven versus competitive dynamics on sampling? Thank you.

僅就 SYFOVRE 的抽樣而言，您能否就抽樣過程中有多少是自我驅動還是競爭驅動的動態因素發表一些評論？謝謝。

Thank you so much for the expectations with C3G and ICMPGN. As I outlined earlier, this is very much in line with what we had expected. We have high expectations. We also feel very good about the demographics that we have established.

非常感謝大家對 C3G 和 ICMPGN 的期待。正如我之前所述，這與我們的預期非常吻合。我們寄予厚望。我們對已建立的人口統計數據也感到非常滿意。

That number of 5,000 we believe is a robust, conservative estimate for the number of patients that are out there and could be helped with our product. Your question on SYFOVRE. I’m sorry but you’re breaking up.

我們認為 5000 這個數字是一個穩健、保守的估計，它代表了目前存在並可能透過我們的產品獲得幫助的患者人數。你對 SYFOVRE 的問題。我很抱歉，但你們要分手了。

I can answer it. It’s on the samples and free goods. Your question was is there a competitive dynamic? I don’t think that’s necessarily the case. What we do know is if someone’s reaching for a free good, that’s true demand. It’s a patient that wants to be treated.

我可以回答這個問題。它適用於樣品和贈品。你的問題是：是否有競爭格局？我不認為情況一定是如此。我們知道的是，如果有人想要獲得免費的東西，那就是真正的需求。這是一位想要接受治療的病人。

It’s a physician that wants to treat the patient. We have those programs in place and monitor them regularly to make sure that they’re within the guidelines that we want to have followed, but they’re accessible because patients that want to go on treatment we believe should be able to do that.

這是一位想要治療病人的醫生。我們已經制定了這些計劃，並定期進行監督，以確保它們符合我們希望遵循的準則，而且這些計劃是可及的，因為我們認為想要接受治療的患者應該能夠做到這一點。

Ryan Deschner, Raymond James.

Ryan Deschner，Raymond James。

Thank you very much. Can you remind us when the actual date EMPAVELI was first made available to patients for the C3G ICMPGN launch. And then also do you have an update on the rough timeline for datadog Top line readout from the phase 2 study for SYFOVRE and APL-3007? Thanks.

非常感謝。您能否提醒我們一下，EMPAVELI 首次用於 C3G ICMPGN 治療的具體日期是什麼時候？另外，您能否提供關於Datadog公司SYFOVRE和APL-3007二期研究主要結果的大致時間表更新？謝謝。

This is David. I’ll answer the first part of the question. We launched the product in the week of July 28. I’ll hand the other portion of the question over on 3007 to Cedric.

這是大衛。我將回答問題的第一部分。我們在7月28日那一週推出了該產品。我將把問題的另一部分交給 3007 號的 Cedric 來回答。

Thank you for that question. The trial is enrolling. We’re very excited about this trial. As a reminder, with APL-3007, what we do is combine SYFOVRE with a subcutaneous injection that is an siRNA product which brings down the systemic levels of C3 by approximately 90%.

謝謝你的提問。該試驗正在招募受試者。我們對這次試驗感到非常興奮。提醒一下，APL-3007 的原理是將 SYFOVRE 與皮下注射的 siRNA 產品結合使用，將全身 C3 水平降低約 90%。

The objective there is to go from every two months to every three month dosing and to then obviously, of course, see an outsized effect on the efficacy side. We’re not guiding in terms of when that study will be completed. It is currently enrolling and has a one year endpoint readout. Thank you.

其目標是將給藥間隔從每兩個月一次改為每三個月一次，這顯然就能在療效方面看到顯著的效果。我們無法就該研究何時完成給出任何指示。該研究目前正在招募受試者，並將於一年後進行終點數據解讀。謝謝。

Douglas Tull, H.C. Wainwright.

道格拉斯·圖爾，H.C. 溫賴特。

Hi, good morning. Thanks for taking the questions. Tim, I think it was you that mentioned that there’s an issue with some practices just having, with the lack of co-pay support, a backlog or operational challenges with practices if, you know, because they’re not able to easily put patients into treatment.

您好，早安。謝謝您回答問題。提姆，我想是你提到過，有些診所由於缺乏共同支付支持，存在積壓或運作方面的挑戰，因為他們無法輕易地讓病人接受治療。

Is that in terms of just the headache within the practice, in terms of just the time it takes to adjudicate benefits and follow that patient, or is it just this patient having an unrealistic expectation of starting treatment and then having themselves put off and having to deal with the frustration on that side.

是指診所內部的麻煩，還是指裁定福利和跟蹤病人所需的時間，還是指病人對開始治療抱有不切實際的期望，然後又被推遲治療，從而不得不面對由此帶來的挫敗感？

Yeah, it’s just really a very complicated situation for the physicians as well as for the patients. Right. You know, kind of figuring out who can afford co-pay, who cannot. I mean, there’s a lot that goes into it. There’s a lot of chair time that is lost by the physician in that process.

是的，這對醫生和病人來說都是一個非常複雜的情況。正確的。你知道，就是要弄清楚誰能負擔得起自付部分，誰負擔不起。我的意思是，這裡面涉及很多方面。在這個過程中，醫生會浪費很多診療時間。

As Tim outlined earlier, what we’ve seen this year is, of course, a lot of slowdown that was driven by these dynamics. Not just on the GA side, also on the wet AMD side where a lot of practices have temporarily paused even bringing on new patients to avoid having those discussions.

正如蒂姆之前概述的那樣，我們今年看到的當然是由這些因素驅動的許多放緩。不僅是 GA 方面，在濕性 AMD 方面也是如此，許多診所甚至暫時停止接收新患者，以避免進行這些討論。

These are all things that are headwinds that we’ll have to find a new place of settlement, but we are working hard on it. We can help practices with availability and access, of course, but the foundation is something that we’re separated from.

這些都是我們尋找新定居點所面臨的阻力，但我們正在努力克服。我們當然可以幫助診所解決資源可用性和可近性問題，但基礎建設是我們無法掌控的。

Of course. I’ll also add that it particularly affects GA patients because there is a generic alternative in the wet AMD space. There is no generic alternative in the GA space.

當然。我還要補充一點，它尤其會影響 GA 患者，因為在濕性 AMD 領域有通用替代療法。遺傳演算法領域沒有通用的替代方案。

If I can, on the kidney launch. I’m just curious. I know obviously something that people have been wondering about in terms of the identification of patients with C3G and ICMPGN. Since it does require a biopsy.

如果可以的話，在腎臟移植手術啟動時。我只是好奇而已。我知道，對於 C3G 和 ICMPGN 患者的識別，人們一直很想知道一些問題。因為確實需要進行切片檢查。

Have you seen evidence that now there is an available treatment like EMPAVELI or such an efficacious treatment that clinicians are [biopsying] more regularly or more aggressively than they were in the past? Thank you.

您是否看到證據表明，現在有像 EMPAVELI 這樣的有效治療方法，或者其他療效顯著的治療方法，使得臨床醫生比過去更頻繁或更積極地進行活檢？謝謝。

That typically happens when there’s a new treatment available for something when there was no previous treatment. There are patients that come out of the woodwork and clinicians are also more motivated to make the diagnosis so they can more effectively treat this disease, which does ultimately end in end stage renal failure. Thank you.

這種情況通常發生在出現一種新的治療方法，而之前沒有其他治療方法的時候。有些患者突然出現，臨床醫生也更有動力做出診斷，以便更有效地治療這種最終會導致末期腎衰竭的疾病。謝謝。

Greg, Mizuho.

Greg，瑞穗。

Good morning. Thank you for taking my question, and congrats on the progress. Just wanted to go back to EMPAVELI. I might have missed it before.

早安.感謝您回答我的問題，也祝賀您的進展。只想再去一次恩帕維利。我之前可能錯過了。

Any way you can provide a sense of the breakout in terms of the revenue and what came from PNH and what came from the new rare kidney indications, and how the 152 and new patient start forms, how that might have contributed to whatever contribution there was to EMPAVELI revenue from the new rare kidney indications. Thanks.

您能否提供一些關於收入細分情況的信息，例如 PNH 的收入佔比是多少，新的罕見腎病適應症的收入佔比是多少，以及 152 名新患者和新患者啟動計劃是如何進行的，這些因素可能對 EMPAVELI 來自新的罕見腎病適應症的收入做出了哪些貢獻？謝謝。

Hey Greg, thank you for the question. This is Tim. Yeah, so you can look at our PNH revenue for the last few quarters. Last quarter we reported, I think, $20.3 million in EMPAVELI revenue and that market has been relatively static.

嗨，格雷格，謝謝你的提問。這是蒂姆。是的，你可以看看我們過去幾季的 PNH 收入。上個季度，我們報告的 EMPAVELI 收入為 2,030 萬美元，而該市場相對穩定。

I think from the perspective of revenue, you can maybe back out a little bit there and look at the fact that we probably are also putting a little bit into inventory at the distributor.

我認為從收入的角度來看，或許可以稍微退後一步，看看我們可能也在經銷商那裡投入了一些庫存。

You know, on a combined basis, we don’t break out that in terms of revenue and we don’t plan to break that out because it is hard for us to do that. Can you repeat the second part of the question?

你知道，從整體來看，我們沒有把這部分收入單獨列出來，我們也不打算這樣做，因為這對我們來說很難做到。你能重複問題的第二部分嗎？

Yeah, just for, if we do. Thanks for that clarity on maybe assuming $20 million or so from PNH and then maybe some inventory build. Whatever the balance is for EMPAVELI revenue in the quarter from the new rare kidney indications.

是的，只是為了，如果我們真的這麼做的話。感謝您澄清了從 PNH 獲得大約 2000 萬美元收入，然後可能會進行一些庫存建設的問題。本季 EMPAVELI 因新的罕見腎臟病適應症而獲得的收入平衡情況如何。

Just trying to get a sense of if you did provide us with $152 in terms of the patient start forms, how much of that is kind of translating into that balance of revenue specifically in rare kidney? Just trying to get a sense of what fourth quarter might look like. Understanding that you’re not providing sales guidance per se.

我只是想了解一下，如果您確實向我們提供了 152 美元的患者啟動表格費用，那麼其中有多少能轉化為罕見腎病方面的收入？只是想了解一下第四季可能會是什麼樣子。請瞭解，您並非在提供銷售指導。

Yeah, we’re not providing sales guidance. We did give you some guidance on sort of an expectation around start forms for the year end, which was 2025.

是的，我們不提供銷售指導。我們確實就年底（即 2025 年）的開始表格的預期給予了一些指導。

I think the way to think about this probably is looking at the time to getting on drug, from start form to getting on drug is approximately four to six weeks. I would just work backwards from that. Okay, thanks so much. Thank you, Greg.

我認為思考這個問題的正確方法是觀察從開始吸毒到開始吸毒所需的時間，大約是四到六週。我會從那裡倒推。好的，非常感謝。謝謝你，格雷格。

Lisa Walter, RBC.

Lisa Walter，RBC。

Great. Thanks so much for taking our questions and congrats on the kidney launch. I was just wondering if you could provide us any color on the pivotal trial design for FSGS and DGF. Thanks so much.

偉大的。非常感謝您回答我們的問題，並祝賀腎臟移植計畫成功啟動。我想請問您能否提供一些關於 FSGS 和 DGF 的關鍵性試驗設計的資訊？非常感謝。

Thank you so much. These trials have just started. We’re not providing details beyond what’s available on ClinicalTrials.gov, but we’re really excited about the opportunity that we have in FSGS and DGF.

太感謝了。這些審判才剛開始。除了 ClinicalTrials.gov 上提供的資訊外，我們不會提供更多細節，但我們對在 FSGS 和 DGF 領域的機會感到非常興奮。

FSGS, as a reminder, affects about 13,000 patients in the US, similar in terms of severity to the patient and the patient’s kidney to what we see with C3G and ICMPGN. We’re looking forward to hopefully having a treatment available for these patients with delayed graft function.

提醒大家，FSGS 在美國影響約 13,000 名患者，就患者及其腎臟的嚴重程度而言，與 C3G 和 ICMPGN 類似。我們期待著能有治療方法來幫助這些移植腎功能延遲恢復的患者。

We are looking into a three-month treatment with EMPAVELI to protect these kidneys that typically come from deceased donors, of which there are 21,000 per year, and about probably 30% of those patients will suffer from that so-called delayed graft function, which is an increase in creatinine in the week post-transplant.

我們正在研究使用 EMPAVELI 進行為期三個月的治療，以保護這些通常來自已故捐贈者的腎臟（每年有 21,000 個腎臟），其中約 30% 的患者可能會出現所謂的移植腎功能延遲恢復，即移植後一周內肌酸酐升高。

Ladies and gentlemen, we have time for one last question and that would come from the line of, it’s a follow-up question from the line of Yigayle Nochemowitz with Citigroup. The line is open.

女士們先生們，我們還有時間回答最後一個問題，這個問題來自花旗集團的 Yigayle Nochemowitz。線路已開通。

Oh, thank you. Thank you. Just one quick follow-up please on the pre-filled syringe. Cedric or Tim or David. I’m just wondering, is that going to be offered also as samples or will. Will it be restricted to just commercial drug for the pre-filled syringe?

哦，謝謝。謝謝。關於預充式註射器，請再補充一個問題。塞德里克、提姆或大衛。我只是想知道，這是否也會作為樣品提供。是否僅限於預充式註射器中的商業藥物？

Thanks. This is David. We will launch with commercial product, and then over time, we’ll have samples available as we get into the launch.

謝謝。這是大衛。我們將首先推出商業產品，然後隨著時間的推移，隨著產品上市的進行，我們將提供樣品。

Thank you. I would like to turn the call back over to Cedric for closing remarks.

謝謝。我謹將電話交還給塞德里克，請他作總結發言。

Thank you so much. Thank you, everybody, for your thoughtful questions. This concludes the Apellis Pharmaceuticals third quarter earnings call, and I hope you all have a wonderful rest of the day.

太感謝了。謝謝大家的提問，你們都很有見地。Apellis Pharmaceuticals 第三季財報電話會議到此結束，祝大家今天餘下的時間愉快。

Ladies and gentlemen, that concludes today’s conference. Thank you for your participation. You may now disconnect.

女士們、先生們，今天的會議到此結束。感謝您的參與。您現在可以斷開連線了。