Apellis Pharmaceuticals Inc (APLS) 2025 Q4 法說會逐字稿

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  • Operator

    Operator

  • Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the Apellis Pharmaceuticals fourth quarter and full year 2025 earnings conference call. Please be advised that today's call is being recorded.

    各位女士、先生,早安。感謝各位耐心等候,歡迎參加 Apellis Pharmaceuticals 2025 年第四季暨全年財報電話會議。敬請注意,今天的電話會議將進行錄音。

  • I will now turn the call over to Eva Stroynowski, Head of Investor Relations. Please go ahead.

    接下來我將把電話交給投資人關係主管 Eva Stroynowski。請開始。

  • Eva Stroynowski - Head of Investor Relations

    Eva Stroynowski - Head of Investor Relations

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

    各位早安,感謝各位加入我們,一同討論 Apellis 2025 年第四季暨全年財務結果。與我一同出席電話會議的有共同創辦人兼執行長 Cedric Francois 博士;商務執行副總裁 David Acheson;醫務長 Caroline Baumal 博士;以及財務長 Tim Sullivan。

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

    在開始之前,我先提醒各位,我們將發表以前瞻性陳述為主的內容,這些陳述係基於我們目前的預期與信念。此等陳述受若干風險與不確定性影響,實際結果可能出現重大差異。我鼓勵各位參閱我們向美國證券交易委員會(SEC)提交之文件中所討論的風險因素,以取得更多細節。

  • Now I'll turn the call over to Cedric.

    現在我把電話交給 Cedric。

  • Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

    Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

  • Thank you, Eva, and thank you all for joining us this morning. Before turning to our fourth-quarter results, I'd like to briefly reflect on the progress Apellis made over the course of 2025. It was a year of disciplined execution and foundation building for our company. We strengthened our commercial franchises, advanced key programs across our pipeline, and continued to demonstrate the value of our differentiated C3 approach, all while maintaining a strong balance sheet and a clear focus on long-term value creation. These foundations position us well as we move ahead with clear priorities centered on execution, growth, and unlocking the next set of value-creating inflection points for Apellis.

    謝謝你,Eva,也謝謝各位今天早上加入我們。在談到第四季業績之前,我想先簡要回顧 Apellis 在 2025 年所取得的進展。這一年對公司而言,是紀律執行與奠基建設的一年。我們強化了商業化事業群、推進了研發管線中的關鍵計畫,並持續展現我們差異化 C3 策略的價值,同時維持強健的資產負債表,並清楚聚焦於長期價值創造。這些基礎使我們在前進時具備良好定位;我們的明確優先事項聚焦於執行、成長,以及釋放 Apellis 下一波創造價值的關鍵轉折點。

  • At our core, Apellis is a company focused on complement biology, specifically targeting C3, the central hub of the complement cascade. By intervening at this central point where all complement pathways converge, we take a fundamentally different approach that enables comprehensive disease control at the root cause while preserving essential immune function. This strategy continues to differentiate us scientifically and commercially and positions us to address a broad range of serious complement-driven diseases.

    Apellis 的核心聚焦於補體生物學,特別是鎖定補體級聯反應的中樞樞紐 C3。透過在所有補體途徑匯聚的中心點介入,我們採取根本不同的方法,得以在保留必要免疫功能的同時,從病因根源達成全面的疾病控制。此一策略在科學與商業層面持續使我們具備差異化,並使我們得以因應廣泛且嚴重的補體驅動疾病。

  • Our 2026 focus remains anchored in our three strategic pillars: first, strengthening SYFOVRE's leadership in geographic atrophy; second, driving growth with EMPAVELI across rare kidney diseases; and third, advancing an innovative pipeline that underpins our next wave of growth.

    我們在 2026 年的重點仍以三大策略支柱為核心:第一,強化 SYFOVRE 在地圖狀萎縮(GA)領域的領導地位;第二,透過 EMPAVELI 推動罕見腎臟疾病的成長;第三,推進創新研發管線,支撐我們下一波成長。

  • Starting with SYFOVRE. SYFOVRE continues to be a resilient and durable business. In 2025, we delivered steady growth in total injections, and we expect SYFOVRE to remain a stable and meaningful revenue stream through 2026. Last month, co-pay assistance programs at third-party organizations began reopening to new patients. While we do not have visibility into how activity may ramp over time, we are encouraged that patients may be able to gain access to treatment.

    先從 SYFOVRE 談起。SYFOVRE 持續展現韌性且具持久性的業務表現。在 2025 年,我們的總注射次數穩健成長,並預期 SYFOVRE 在 2026 年仍將是穩定且重要的營收來源。上個月,第三方機構的自付額補助計畫開始重新對新病患開放。雖然我們無法掌握相關活動將如何隨時間提升,但我們樂見病患可能得以取得治療。

  • Looking ahead, we are advancing key initiatives to lay the foundation for accelerated growth in 2027, including a best-in-class prefilled syringe, and OCT-F, our AI-enabled approach to visualize the functional benefits SYFOVRE can provide for patients. Together, these initiatives are designed to make treatment more tangible, improve workflow and support broader adoption over time.

    展望未來,我們正推進多項關鍵計畫,為 2027 年加速成長奠定基礎,包括同級最佳的預充式注射器,以及 OCT-F——我們以 AI 賦能的方式,用於視覺化呈現 SYFOVRE 可為病患帶來的功能性效益。這些計畫共同目標在於讓治療效益更具體可感、改善工作流程,並隨時間推進更廣泛的採用。

  • Turning now to our second pillar, EMPAVELI. EMPAVELI is our near-term growth engine, and its launch trajectory reinforces our confidence in its long-term value. Following FDA approval in July for patients with C3G and primary IC-MPGN, the launch has progressed fully in line with our internal expectations, reflecting strong execution and early market receptivity.

    接著談第二個支柱:EMPAVELI。EMPAVELI 是我們短期的成長引擎,其上市推進軌跡強化了我們對其長期價值的信心。在 7 月獲 FDA 核准用於 C3G 與原發性 IC-MPGN 病患後,上市進展完全符合我們內部預期,反映出強勁的執行力與市場早期的正向回饋。

  • After its first full quarter on the market, EMPAVELI achieved more than 5% market penetration, significantly outpacing other rare nephrology launches. We continue to receive outstanding feedback from the community, with growing appreciation of EMPAVELI's value proposition following the publication of our data in the New England Journal of Medicine. We believe EMPAVELI's strong efficacy and safety profile will continue to drive adoption, and that over time, it has the potential to be used by up to 50% of the estimated 5,000 US patient population.

    在上市後第一個完整季度,EMPAVELI 的市占滲透率已超過 5%,顯著快於其他罕見腎臟科產品的上市表現。隨著我們的數據發表於《新英格蘭醫學期刊》(New England Journal of Medicine),我們持續收到社群極佳的回饋,對 EMPAVELI 價值主張的認同也日益提升。我們相信 EMPAVELI 強勁的療效與安全性特徵將持續推動採用;長期而言,其有潛力被估計約 5,000 名美國病患族群中的多達 50% 使用。

  • Lastly, our third pillar, which is our innovative pipeline. In nephrology, we are building on the momentum of EMPAVELI and expanding the franchise into new indications with pivotal trials now underway in focal segmental glomerulosclerosis and delayed graft function.

    最後是第三個支柱:我們的創新研發管線。在腎臟科領域,我們正延續 EMPAVELI 的動能,並將事業群擴展至新的適應症;目前針對局灶節段性腎小球硬化症(FSGS)與延遲移植物功能(DGF)的關鍵性試驗已在進行中。

  • In geographic atrophy, we are further bolstering SYFOVRE's leadership through our next-generation strategy, combining SYFOVRE with APL-3007, designed to enhance efficacy, patient experience and further differentiate our offerings.

    在地圖狀萎縮方面,我們透過下一代策略進一步鞏固 SYFOVRE 的領導地位,將 SYFOVRE 與 APL-3007 結合,旨在提升療效與病患體驗,並進一步強化我們產品的差異化。

  • We are also excited to advance APL-9099, our category-defining FcRn program. This first-in-class base editing approach has the potential to disrupt a multibillion-dollar market and enable a one-and-done treatment paradigm across multiple indications. These programs reflect the breadth, strategic depth, and long-term ambition of our pipeline. With a strong balance sheet and a growing commercial revenue base, we are well positioned to self-fund our pipeline and drive long-term value through disciplined financial execution.

    我們也很期待推進 APL-9099——我們具類別定義意義的 FcRn 計畫。此一同級首創的鹼基編輯(base editing)方法,具備顛覆數十億美元市場的潛力,並可在多項適應症上實現一次性完成(one-and-done)的治療模式。這些計畫反映了我們研發管線的廣度、策略深度與長期企圖。憑藉強健的資產負債表與持續成長的商業化營收基礎,我們具備良好條件以自有資金支持研發管線,並透過紀律性的財務執行推動長期價值。

  • And with that, I will now turn the call over to David for an update on our commercial performance.

    接下來,我把電話交給 David,請他更新我們的商業化表現。

  • David Acheson - Executive Vice President of Commercial

    David Acheson - Executive Vice President of Commercial

  • Thank you, Cedric, and good morning, everyone. I'll begin with SYFOVRE. As Cedric highlighted, 2025 reinforced that SYFOVRE is a resilient and durable business. While full year revenue was modestly down compared to 2024, largely due to elevated use of free goods, the underlying demand remains strong with total injections growing approximately 17% year over year. SYFOVRE continues to lead the GA market.

    謝謝你,Cedric,各位早安。我先從 SYFOVRE 談起。如 Cedric 所強調,2025 年再次證明 SYFOVRE 是一項具韌性且可持續的業務。雖然全年營收相較 2024 年小幅下降,主要是因為免費供貨(free goods)使用增加,但基本需求仍然強勁,總注射次數年增約 17%。SYFOVRE 仍持續領先 GA 市場。

  • Physicians and patients value its differentiated profile, including robust efficacy and the flexibility of dosing as few as 6 times per year. Payer coverage remains strong with preferred status across a broad range of plans. As the GA market continues to evolve, we see meaningful opportunity for SYFOVRE and are focused on three priorities to support continued expansion and long-term growth.

    醫師與病患重視其差異化特徵,包括穩健的療效,以及每年最少僅需 6 次給藥的彈性。付款方(payer)給付覆蓋仍然強勁,在廣泛的保險方案中維持優先地位。隨著 GA 市場持續演進,我們看見 SYFOVRE 的重大機會,並聚焦三項優先事項,以支持持續擴張與長期成長。

  • First, sharpening our field engagement through physician segmentation, refined messaging and a greater emphasis on early career retina specialists. Second, reinforcing our data leadership in GA. SYFOVRE is supported by the most extensive clinical and real-world evidence base in the category, anchored by five-year GALE data; and third, advancing innovation with a best-in-class prefilled syringe and OCT-F.

    第一,透過醫師分群、精煉訊息傳遞,並更著重於職涯早期的視網膜專科醫師,以強化我們的前線互動。第二,鞏固我們在 GA 的數據領導地位。SYFOVRE 擁有本類別中最廣泛的臨床與真實世界證據基礎,以五年期 GALE 數據為核心;第三,推進創新,包括同級最佳的預充式注射器與 OCT-F。

  • Together, these initiatives are foundational to supporting broader growth in 2027 and beyond. Turning to EMPAVELI. We are very pleased with the progress in C3G and primary IC-MPGN launch with early uptake fully consistent with our expectations. Following its first full quarter post launch, EMPAVELI achieved more than 5% market penetration. This level of early adoption is particularly notable in nephrology, a specialty known for conservative prescribing behavior and high evidentiary thresholds.

    綜合而言,這些計畫是支持 2027 年及之後更廣泛成長的基礎。接著談 EMPAVELI。我們對 EMPAVELI 在 C3G 與原發性 IC-MPGN 的上市進展非常滿意,早期採用情況完全符合我們的預期。在上市後第一個完整季度,EMPAVELI 的市占滲透率已超過 5%。這樣的早期採用程度在腎臟科尤其值得注意,因為該專科以處方行為保守且對證據門檻要求高而聞名。

  • As of year-end 2025, we received 267 cumulative patient start forms, reflecting strong early demand and a growing patient pipeline. Demand is being driven by broad engagement across the nephrology community and supported by favorable payer access with 95% of published policies reimbursing to label or with minimal restrictions. Physicians consistently highlight EMPAVELI's compelling efficacy profile, along with the convenience and ease of use of its on-body auto-injector and twice weekly dosing.With its broad label, EMPAVELI is the only approved therapy for approximately two-thirds of patients with C3G and primary IC-MPGN in the US.

    截至2025年年底,我們累計收到267份患者啟用表(patient start forms),反映出強勁的早期需求以及持續擴大的患者儲備。需求來自腎臟科社群的廣泛投入所帶動,並受惠於有利的支付方給付可近性:已公布的給付政策中有95%依標籤(label)給付或僅有極少限制。醫師一再強調EMPAVELI具吸引力的療效特徵,以及其貼身式自動注射器(on-body auto-injector)的便利性與易用性,並採每週兩次給藥。憑藉其廣泛的適應症標籤,EMPAVELI是美國約三分之二C3G與原發性IC-MPGN患者唯一獲核准的治療選項。

  • As the launch has progressed, we have expanded meaningfully across prescriber community, increasing both the breadth and depth of engagement. Over time, physicians are gaining experience in treating additional patients, reflecting growing confidence as the launch matures. Importantly, this execution has translated into strong patient pipeline. Early identification and engagement efforts over the first six months have positioned us well for continued growth, and we remain focused on broadening and deepening that pipeline as the market develops.

    隨著上市推進,我們在處方醫師社群中的覆蓋與投入已顯著擴大,無論廣度或深度皆有提升。隨時間推移,醫師在治療更多患者方面累積經驗,反映出隨著上市成熟而增長的信心。重要的是,這樣的執行已轉化為強勁的患者儲備。前六個月的早期辨識與互動工作使我們為持續成長奠定良好基礎;隨著市場發展,我們仍專注於擴大並深化該患者儲備。

  • As we look ahead, our 2026 launch priorities are focused on three clear areas: first, strengthening the patient identification through targeted medical education to both improve diagnosis and drive urgency around earlier treatment; second, expanding engagement with prescribing physicians. We began the launch with a disciplined focus on our top 20 accounts, which represent more than 30% of the overall market and have accounted for approximately one-third of patient start forms. We are now systematically broadening engagement across additional tiers through targeted field activity and peer-to-peer education.

    展望未來,我們2026年的上市優先事項聚焦於三個明確領域:第一,透過具針對性的醫學教育強化患者辨識,以同時改善診斷並提升對更早治療的急迫性;第二,擴大與開立處方醫師的互動。我們在上市初期以嚴謹的策略聚焦於前20大帳戶,這些帳戶代表整體市場的30%以上,並貢獻約三分之一的患者啟用表。我們目前正透過具針對性的外勤活動與同儕對同儕(peer-to-peer)教育,有系統地將互動擴展至其他層級的帳戶。

  • And third, deepening adoption across patient segments. We continue to see strong interest from pediatric and post-transplant patients with growing opportunity in the adult population as the treatment paradigm shifts and clinical practice continues to evolve.

    第三,深化在不同患者族群中的採用。我們持續看到兒科與移植後患者的高度興趣;隨著治療典範轉移與臨床實務持續演進,成人族群也展現出日益增加的機會。

  • Overall, the launch is progressing very well. We entered 2026 with strong momentum, and we believe that strength will continue through the year with some quarter-to-quarter variability. We believe EMPAVELI is on a clear trajectory to blockbuster status and that it could ultimately be used by up to half of US C3G and primary IC-MPGN patient population.

    整體而言,上市進展非常順利。我們以強勁動能進入2026年,並相信這股力道將在全年延續,儘管各季之間可能出現一定波動。我們認為EMPAVELI正朝向重磅藥(blockbuster)地位的明確軌道前進,且最終可能可供多達美國C3G與原發性IC-MPGN患者族群的一半使用。

  • With that, I'll turn the call over to Caroline.

    接下來,我把電話交給Caroline。

  • Caroline Baumal - Chief Medical Officer

    Caroline Baumal - Chief Medical Officer

  • Thanks, David. I'll begin with SYFOVRE. As the only approved therapy that targets C3, SYFOVRE addresses the central biology driving geographic atrophy, which continues to differentiate its clinical profile. In the fourth quarter, we announced new five-year data from a post-hoc analysis of the GALE extension study, which showed that SYFOVRE delayed progression of geographic atrophy by approximately 1.5 years in patients with nonsubfoveal GA when compared to sham or projected sham.

    謝謝你,David。我先從SYFOVRE開始。作為唯一獲核准、以C3為標的的治療,SYFOVRE針對驅動地圖狀萎縮(geographic atrophy)的核心生物機制,這也持續使其臨床特徵更具差異化。在第四季,我們公布了GALE延伸研究事後分析(post-hoc analysis)的最新五年數據,顯示相較於安慰劑(sham)或推估的安慰劑,SYFOVRE在非中央凹下(nonsubfoveal)GA患者中可將地圖狀萎縮的進展延後約1.5年。

  • We look forward to presenting the full five-year data set at the Macula Society later this week as one of our eight oral presentations at the conference. Looking ahead, we are advancing two initiatives designed to support clinical decision-making and real-world use. First, our prefilled syringe intended to improve efficiency in retina practices.

    我們期待在本週稍晚的Macula Society會議上完整呈現五年數據集,這將是我們在該會議八場口頭報告之一。展望未來,我們正推進兩項計畫,以支持臨床決策與真實世界使用。第一項是我們的預充式注射器(prefilled syringe),旨在提升視網膜診所的作業效率。

  • The clinical study is complete, and we are working toward a regulatory submission in the first half of this year. Second, we continue to make important progress with functional OCT, our AI-enabled approach to visualizing functional benefit in GA. We recently shared data at the Angiogenesis meeting earlier this month and plan to make the tool available for research use in retina practices in the second half of this year.

    臨床研究已完成,我們正朝今年上半年提交法規申請(regulatory submission)推進。第二,我們在功能性OCT(functional OCT)方面持續取得重要進展;這是我們以AI賦能、用於呈現GA功能性獲益的可視化方法。我們本月稍早已在Angiogenesis會議分享相關數據,並計畫於今年下半年在視網膜診所提供該工具供研究使用。

  • In parallel, we continue to advance the Phase 2 study of SYFOVRE in combination with APL-3007 as a next-generation approach designed to more comprehensively block complement activity in the retina and choroid. We expect to share top-line data in 2027.

    同時,我們也持續推進SYFOVRE與APL-3007合併治療的第2期研究,作為下一代策略,旨在更全面阻斷視網膜與脈絡膜中的補體活性。我們預期於2027年分享主要結果(top-line data)。

  • Now turning to EMPAVELI in C3G and primary IC-MPGN. Physician feedback and the recent New England Journal of Medicine publication continue to reinforce EMPAVELI's differentiated profile. As the only C3 targeting therapy, EMPAVELI has demonstrated the trifecta of efficacy outcomes with direct clearance of C3 deposits translating into reduced proteinuria and stabilization of kidney function. These data reinforce our confidence in EMPAVELI's mechanism and its potential to redefine treatments in complement-mediated kidney disease.

    接著談EMPAVELI在C3G與原發性IC-MPGN的進展。醫師回饋以及近期《新英格蘭醫學期刊》(New England Journal of Medicine)的發表,持續強化EMPAVELI的差異化特徵。作為唯一以C3為標的的治療,EMPAVELI已展現療效結果的「三重奏」:直接清除C3沉積,進而降低蛋白尿並穩定腎功能。這些數據強化了我們對EMPAVELI作用機轉的信心,以及其在補體介導腎臟疾病中重新定義治療方式的潛力。

  • We also recently initiated pivotal trials with EMPAVELI in FSGS and DGF, two additional high unmet need kidney indications. Both conditions are strongly linked to complement activation and currently have no FDA-approved therapies.

    我們近期也已啟動EMPAVELI在FSGS與DGF兩項額外高未滿足需求腎臟適應症的關鍵性試驗(pivotal trials)。這兩種疾病皆與補體活化高度相關,且目前均無FDA核准的治療。

  • Finally, I'll briefly touch on APL-9099, our FcRn program. This first-in-class base editing approach is designed to reduce IgG levels while preserving albumin, which we believe addresses important limitations of existing FcRn therapies. We expect to submit an IND in the second half of this year and look forward to sharing more details as the program progresses.

    最後,我簡要提及APL-9099,也就是我們的FcRn計畫。這項同類首創(first-in-class)的鹼基編輯(base editing)方法,旨在降低IgG濃度,同時保留白蛋白(albumin);我們相信這可解決現有FcRn療法的重要限制。我們預期於今年下半年提交IND,並期待隨著計畫推進分享更多細節。

  • With that, I'll now turn the call over to Tim.

    接下來,我把電話交給Tim。

  • Timothy Sullivan - Chief Financial Officer, Treasurer

    Timothy Sullivan - Chief Financial Officer, Treasurer

  • Thank you, Caroline. I'll now walk through our financial results. Additional details are included in this morning's press release. Total revenue for the fourth quarter and full year 2025 was $200 million and $1 billion, respectively. As a reminder, full year 2025 revenue includes the onetime $275 million upfront payment from the Sobi royalty repurchase agreement.

    謝謝你,Caroline。我接著說明我們的財務結果。更多細節已包含在今天早上的新聞稿中。2025年第四季與全年總營收分別為2億美元與10億美元。提醒一下,2025年全年營收包含一次性2.75億美元的預付款,來自與Sobi之權利金回購協議(royalty repurchase agreement)。

  • We reported SYFOVRE net product revenue of $155 million for the fourth quarter and $587 million for the full year 2025. During the fourth quarter, we delivered approximately 102,000 SYFOVRE doses to physician offices, including approximately 89,000 commercial doses and 13,000 free goods doses. As previously discussed, reported revenue was meaningfully impacted due to elevated free goods utilization through 2025.

    我們公布SYFOVRE第四季產品淨營收為1.55億美元,2025年全年為5.87億美元。第四季期間,我們向醫師診所交付約102,000劑SYFOVRE,其中約89,000劑為商業劑量,13,000劑為免費供貨(free goods)劑量。如先前所述,由於2025年免費供貨使用率偏高,已對認列營收造成顯著影響。

  • Looking ahead, we remain committed to supporting patient access while recognizing that free goods utilization may evolve over time as third-party programs resume activity.

    展望未來,我們仍致力於支持患者可近性,同時也認知到,隨著第三方計畫恢復運作,免費供貨的使用情況可能會隨時間演變。

  • Turning to gross to net. SYFOVRE adjustments in the fourth quarter trended just above the mid-20% range. In 2026, we expect gross to net to be in the high 20% range, reflecting the normal step-wise evolution of the buy-and-bill market. Importantly, based on our current pricing strategy, we expect net price to remain relatively stable through 2026, and we remain confident in our access position.

    接著談毛額到淨額(gross to net)。SYFOVRE在第四季的調整幅度走勢略高於20%中段區間。2026年,我們預期毛額到淨額將落在20%高段區間,反映買斷後請款(buy-and-bill)市場的正常階梯式演進。重要的是,基於我們目前的定價策略,我們預期淨價格在2026年將維持相對穩定,且我們對自身的可近性地位仍具信心。

  • As we exited 2025, we took a disciplined approach to inventory management, and we are comfortable with the current channel levels. We, therefore, expect a modest inventory reduction in the first quarter alongside typical seasonal dynamics, including Medicare reverifications.

    在2025年年底,我們以嚴謹方式管理庫存,並對目前通路庫存水位感到安心。因此,我們預期第一季將出現溫和的庫存下降,同時伴隨典型的季節性因素,包括Medicare重新驗證(reverifications)。

  • Overall, SYFOVRE remains a meaningful and durable foundation for Apellis. In 2026, we are focused on disciplined execution while advancing initiatives that position the business for renewed growth in 2027 and beyond.

    整體而言,SYFOVRE仍是Apellis重要且具持久性的基礎。2026年,我們聚焦於嚴謹執行,同時推進各項計畫,使業務在2027年及之後重新回到成長軌道。

  • Moving to EMPAVELI. We reported US net product revenue of $35 million for the fourth quarter and $102 million for the full year 2025. As David noted earlier, the launch continues to progress very well. And based on current trends, we believe EMPAVELI is on a clear path to blockbuster status.

    接著談EMPAVELI。我們公布EMPAVELI在美國的產品淨營收第四季為3,500萬美元,2025年全年為1.02億美元。如David先前提到,上市持續進展非常順利。並且基於目前趨勢,我們認為EMPAVELI正明確走在成為重磅藥(blockbuster)的道路上。

  • For operating expenses, we continue to maintain a highly disciplined approach to cost management. Operating expenses were $251 million in the fourth quarter compared with $239 million in the same period last year. For the full year 2025, operating expenses were in line with our expectations and consistent with 2024 levels. In 2026, we expect operating expenses to be modestly higher with incremental investment in the newly initiated pivotal trials for FSGS and DGF as well as certain milestone payments, largely offset by a decrease in SG&A, reflecting ongoing operating efficiency and resource optimization.

    在營運費用方面,我們持續以高度自律的方式進行成本管理。第四季營運費用為2.51億美元,較去年同期的2.39億美元增加。2025全年營運費用符合我們的預期,並與2024年的水準一致。展望2026年,我們預期營運費用將小幅上升,主要因新增對FSGS與DGF新啟動之關鍵性(pivotal)試驗的增量投資,以及部分里程碑付款;上述增加將在很大程度上被SG&A(銷售、一般及行政費用)的下降所抵銷,反映我們持續提升營運效率與資源最佳化。

  • We ended the year with $466 million in cash and cash equivalents, which we believe provides us with substantial flexibility and the resources to fund the business to profitability. As a reminder, Sobi recently received European Commission approval for Aspaveli in C3G and primary IC-MPGN, which triggered a $25 million milestone payment to Apellis during the first quarter of this year.

    我們在年底持有4.66億美元的現金及約當現金,我們認為這為我們提供了相當大的彈性,以及將業務資助至達成獲利所需的資源。提醒一下,Sobi近期已獲歐盟執委會核准Aspaveli用於C3G與原發性IC-MPGN,並因此在今年第一季觸發Sobi向Apellis支付2,500萬美元的里程碑款。

  • We also remain focused on prudent capital structure management. We have approximately $94 million of convertible debt outstanding, which matures in September of this year, and we are actively evaluating a range of alternatives to address this obligation in a thoughtful and disciplined way.

    我們也持續專注於審慎的資本結構管理。我們目前約有9,400萬美元的可轉換債務在外流通,將於今年9月到期;我們正積極評估多種替代方案,以周全且自律的方式處理此項義務。

  • And with that, I will now turn the call back over to Cedric.

    接下來,我將把電話交回給Cedric。

  • Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

    Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

  • Thank you, Tim. As we move through 2026, our priorities are clear. We are focused on disciplined execution across our commercial portfolio, advancing initiatives that support long-term growth and continuing to deliver meaningful impact for patients. EMPAVELI is gaining traction in C3G and primary IC-MPGN, while SYFOVRE provides a durable foundation as we position the franchise for its next phase of growth.

    謝謝你,Tim。隨著我們邁入2026年,我們的優先事項很明確。我們將專注於在商業產品組合上自律執行,推進支持長期成長的各項計畫,並持續為病患帶來有意義的影響。EMPAVELI在C3G與原發性IC-MPGN的動能正在增強,而SYFOVRE則提供穩固且持久的基礎,協助我們為該產品線的下一階段成長做好布局。

  • Supported by a strong balance sheet and financial rigor, we are operating from a position of strength and remain confident in our ability to create durable value for patients and shareholders.

    在強健的資產負債表與嚴謹的財務紀律支持下,我們正以優勢地位營運,並對我們為病患與股東創造持久價值的能力保持信心。

  • And with that, I will now turn the call over to the operator for Q&A.

    接下來,我將把電話交給主持人進行問答。

  • Operator

    Operator

  • (Operator Instructions) Jon Miller, Evercore ISI.

    (主持人指示)Jon Miller,Evercore ISI。

  • Jonathan Miller - Analyst

    Jonathan Miller - Analyst

  • On the progress throughout '25. I'd like to use my one question to ask about EMPAVELI launch as we get into '26. You mentioned opening to broaden the accounts there and improve patient identification, diagnosis and all of that.

    關於你們在2025年的進展。我想用我唯一的一個問題來問EMPAVELI在進入2026年的上市推進情況。你提到會擴大覆蓋的帳戶並改善病患辨識、診斷等各方面。

  • But I noticed that one of the things that you didn't mention when you were listing the indications where there was strong growth potential was IC-MPGN, where obviously you have a differentiated label, but historically, it's been a little bit more challenging to find those patients.

    但我注意到,你在列舉具有強勁成長潛力的適應症時,沒有提到IC-MPGN;很明顯你們在該適應症上有差異化的標示(label),但歷來要找到這些病患一直比較具挑戰。

  • Can you talk a little bit about the breakdown of different indications throughout 2026, where you think the low-hanging fruit is, where we can see real growth in the near term and what it will take to break open some of those indication subsets that are a little bit tougher to diagnose and get on treatment?

    你能否談談2026年不同適應症的構成分布?你認為哪些是「低垂的果實」能在短期帶來實質成長?以及要如何才能打開那些較難診斷、較難讓病患開始治療的適應症子族群?

  • Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

    Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

  • Thank you so much, Jon, and great hearing you. And thank you, everyone, for joining. So EMPAVELI is on a clear path to blockbuster status. And as you correctly outlined, John, there's not just IC-MPGN, there's also the fact that in the VALO study, we studied EMPAVELI in the pediatric population as well as in a post-transplant setting as well.

    非常感謝你,Jon,也很高興聽到你的聲音。也謝謝各位參與。EMPAVELI正走在成為重磅產品(blockbuster)的明確道路上。而如你所說,Jon,不僅是IC-MPGN;此外在VALO研究中,我們也在兒科族群以及移植後(post-transplant)情境中研究了EMPAVELI。

  • Now specifically as it relates to IC-MPGN, we believe that the epidemiology in total between the two indications is approximately 5,000 patients in the US, split more or less 50-50 between those two indications. While we're not providing exact breakdowns as to where in the population, things sit at the moment, it is worth noting that in the pediatric population, the IC-MPGN in the post-transplant segment, we see important pickup and differentiation. And that, of course, contributed to achieving more than 5% penetration after the first full quarter in Q4 and contributes to our confidence of reaching up to 50% of those 5,000 patients at peak.

    就IC-MPGN而言,我們認為這兩個適應症合計在美國的流行病學患者數約為5,000人,兩者大致各占一半。雖然我們目前不提供精確的族群拆分,但值得注意的是,在兒科族群、IC-MPGN以及移植後分群中,我們看到重要的增量與差異化。這也促成我們在第四季第一個完整季度後達到超過5%的滲透率,並強化我們對於在高峰期可觸及這5,000名患者中多達50%的信心。

  • Jonathan Miller - Analyst

    Jonathan Miller - Analyst

  • But I guess if you're going to see 50% penetration at peak and IC-MPGN is 50% of the US population, I guess I'm asking, are you going to see equivalent penetration across those different subpopulations, those different subindications by the end of the day? Or are there places that are going to remain more difficult to penetrate?

    但如果你們在高峰期要達到50%的滲透率,而IC-MPGN又占美國患者的一半,我想問的是:到最後,你們會在不同子族群、不同子適應症之間看到相近的滲透率嗎?還是有些領域仍會更難滲透?

  • Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

    Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

  • It's a little early to say that exactly, I think, at this moment in time. It's also important to note that there's quite a bit of overlap between these two indications. There's not kind of a hard separation between them in the sense that you can have a patient with a biopsy one day that is more leaning towards C3G and on another biopsy can mean more towards IC-MPGN, which is why it is so important to have covered all phenotypes of the disease -- of these diseases, sorry, in the clinical trials that we ran. So it's a little bit too early to provide more specifics on that.

    我認為現在要非常精確地下結論還為時過早。同時也很重要的一點是,這兩個適應症之間存在相當程度的重疊。它們並非截然分開;例如同一位病患某天的活檢結果可能更偏向C3G,而另一次活檢可能更偏向IC-MPGN。這也是為什麼在我們進行的臨床試驗中,涵蓋這些疾病的所有表型如此重要——抱歉,是這些疾病。因此,目前還太早提供更具體的說明。

  • Operator

    Operator

  • Anupam Rama, JPMorgan.

    Anupam Rama,摩根大通(JPMorgan)。

  • Anupam Rama - Analyst

    Anupam Rama - Analyst

  • For SYFOVRE, you've got the five-year GALE data this Friday that you guys highlighted. What would you have us focus in on within these data?

    關於SYFOVRE,你們本週五將公布你們提到的五年期GALE數據。你希望我們在這些數據中重點關注什麼?

  • Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

    Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

  • Thank you so much, Anupam. Well, the important benefits and the continued safety profile that SYFOVRE provides to patients with geographic atrophy, right? So it is by far the largest data set ever generated in geographic atrophy. And what we found through the course of following these patients for a full five-year period is that patients who are on treatment for 5 years can save as much as 1.5 year of tissue.

    非常感謝你,Anupam。重點在於SYFOVRE為地圖狀萎縮(geographic atrophy)患者帶來的重要效益,以及其持續一致的安全性特徵。這是迄今在地圖狀萎縮領域所產生的最大資料集。我們在完整追蹤這些患者五年後發現,接受治療滿5年的患者,最多可「保留」約1.5年的視網膜組織。

  • So as I think you can appreciate, that's an enormous benefit to 70- or 75-year-old individual who obviously, in the twilights of their lives depends so much on their vision. So we're incredibly proud and incredibly happy with the data that we have generated and look forward to presenting it on Friday. I don't know, Caroline, if you would like to add something.

    如你所理解,對於70或75歲的人而言,這是非常巨大的益處;他們在生命的晚年非常依賴視力。因此,我們對所產生的數據感到非常自豪,也非常滿意,並期待在週五進行發表。我不知道,Caroline,你是否想補充一些。

  • Caroline Baumal - Chief Medical Officer

    Caroline Baumal - Chief Medical Officer

  • Thank you, Cedric. I think what will be meaningful for retina physicians is that we have this extended trial with five years of data that we continue to show increasing effects over time and that retina tissue can be meaningfully saved. And these findings might lead to earlier treatment for patients with geographic atrophy. So we really look forward to presenting this data. Thank you.

    謝謝你,Cedric。我認為對視網膜科醫師而言,有意義的是:我們有這項延伸試驗的五年數據,持續顯示療效會隨時間增加,且能夠有意義地保留視網膜組織。這些發現可能會促使地圖狀萎縮患者更早開始治療。因此我們非常期待發表這些數據。謝謝。

  • Operator

    Operator

  • Tazeen Ahmad, Bank of America.

    Tazeen Ahmad,美國銀行(Bank of America)。

  • Tazeen Ahmad - Analyst

    Tazeen Ahmad - Analyst

  • I maybe wanted to follow up on that 50% penetration for EMPAVELI. How long do you think it's going to take to reach that? I know that a big point of discussion among investors is like the ramp of your launch. Is it going to be more steady? Or could it accelerate and become more steep? So any thoughts you can provide on patient finding efforts and what you think realistically the time to onboard patients will take? That would be helpful.

    我想追問一下EMPAVELI的50%滲透率。你認為達到那個水準需要多久?我知道投資人討論的一個重點是你們上市推進的爬坡速度。會比較穩健、循序漸進嗎?還是可能加速、變得更陡峭?所以你能否分享一些對於找病患(patient finding)工作的看法,以及你認為實際上讓病患完成導入(onboard)大概需要多久?這會很有幫助。

  • And then can you just talk about what the competitive dynamics are so far relative to how doctors are viewing EMPAVELI versus FABHALTA? What are the types of patients that they might still be waiting to see if EMPAVELI might be better than relative to FABHALTA?

    另外,你能否談談目前的競爭態勢:醫師如何看待EMPAVELI相對於FABHALTA?有哪些類型的患者,醫師可能仍在觀望,想看看EMPAVELI是否會比FABHALTA更適合?

  • Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

    Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

  • Thank you so much, Tazeen. Well, as it relates to the ramp, I think you correctly outlined that we should expect steady ramp and steady growth as is quite typical in rare diseases. And again, I think we have seen that happen in the past couple of months and expect that to continue to be the case.

    非常感謝你,Tazeen。嗯,關於放量爬坡(ramp),我認為你正確地概述了:我們應該預期穩健的爬坡與穩健的成長,這在罕見疾病領域相當典型。再者,我想我們在過去幾個月已經看到這種情況發生,並預期未來也會持續如此。

  • Competitively, as already outlined when Jon asked the question, there is kind of the clear differentiation that we have and kind of the unique positioning without competition right now in the pediatric segment as well as in IC-MPGN -- that is, of course, a huge advantage.

    在競爭面上,如同先前 Jon 提問時已經說明的,我們具有相當明確的差異化,以及目前在兒科族群與 IC-MPGN 領域沒有競品的獨特定位——這當然是巨大的優勢。

  • Also in the pediatric population, I think the disease tends to progress more quickly. And what you see in the field based on what we have seen since the launch is that the appreciation for the efficacy and safety profile of the drug really stands out. Also in the post-transplant segment, of course, that is a very important place. Most -- majority of patients with these diseases will have a relapse because this is a genetic condition at the end of the day.

    另外在兒科族群中,我認為疾病往往進展更快。而根據我們自上市以來在第一線所觀察到的情況,大家對於該藥物的療效與安全性特徵的認可度非常突出。此外,在移植後族群中,當然那也是非常重要的一塊。多數——這些疾病的大多數患者最終都會復發,因為說到底這是一種遺傳性疾病。

  • Operator

    Operator

  • Timur Ivannikov, Cantor.

    Timur Ivannikov,Cantor。

  • Timur Ivannikov - Analyst

    Timur Ivannikov - Analyst

  • This is Timur on for Steve Seedhouse. For EMPAVELI launch, I think you mentioned strong momentum in C3G in 2026 with quarter-to-quarter variability. Could you talk about some of the variability factors? And do you expect to provide start forms again at some point or any other form of guidance?

    我是 Timur,代 Steve Seedhouse 提問。關於 EMPAVELI 的上市推進,我想你提到 2026 年在 C3G 方面動能強勁,但季度之間會有波動。你能談談造成波動的一些因素嗎?另外,你們是否預期在某個時間點再次提供 start forms(起始用藥表單)數據,或提供任何其他形式的指引?

  • Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

    Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

  • Thank you so much, Timur. I will hand that question over to David Acheson.

    非常感謝你,Timur。我把這個問題交給 David Acheson 來回答。

  • David Acheson - Executive Vice President of Commercial

    David Acheson - Executive Vice President of Commercial

  • Hope you're doing well. Thank you for the question. So on the variability, it's just -- it's ultra-rare disease. I think it's important to note that you'll see an influx of potential patients coming in on start forms. That does vary week over week, month over month.

    希望你一切都好。謝謝你的提問。關於波動性,這畢竟是超罕見疾病。我認為重要的是要注意,你會看到潛在患者在 start forms 上的流入。而這確實會出現週與週、月與月之間的變動。

  • So I think it's just something that we need to pay attention to. But I feel very good about the momentum that we came into 2026 with -- from the launch last year on the strength of the product and the patients that we're getting on the brand, which is very positive. And can you repeat the second part of your question for me?

    所以我認為這就是我們需要持續關注的事情。但我對我們帶著動能進入 2026 年感到非常有信心——這動能來自去年上市、產品本身的優勢,以及我們讓患者開始使用本品牌的進展,這些都非常正面。你可以再重複一下你問題的第二部分嗎?

  • Timur Ivannikov - Analyst

    Timur Ivannikov - Analyst

  • Yeah. I was just wondering about the start forms or any other type of guidance for the product.

    好的。我只是想問關於 start forms 或任何其他類型的產品指引。

  • David Acheson - Executive Vice President of Commercial

    David Acheson - Executive Vice President of Commercial

  • Yeah. So moving forward, we continue to report on revenues for sure and start forms, but we're not going to give any additional guidance on start forms that we had in the third to fourth quarter.

    好的。所以往後我們當然會持續揭露營收以及 start forms,但我們不會再提供任何額外的 start forms 指引,超出我們在第三到第四季所提供的內容。

  • Operator

    Operator

  • Yigal Nochomovitz, Citigroup.

    Yigal Nochomovitz,花旗集團(Citigroup)。

  • Yigal Nochomovitz - Analyst

    Yigal Nochomovitz - Analyst

  • Could you talk a bit about the prefilled syringe? I just want to get a sense of how much it matters for the retina docs in terms of the practice flow and efficiency. And when you say renewed growth in 2027 for SYFOVRE is the driver behind the statement, the launch of the PFS.

    你能談談預充式注射器(prefilled syringe)嗎?我想了解它對視網膜科醫師在診所流程與效率方面到底有多重要。另外,當你說 2027 年 SYFOVRE 會恢復成長時,這個說法背後的驅動因素是 PFS 的上市嗎?

  • And then more specifically on the practice dynamics, since the space is very limited for the physicians, for the fridges to store the drug, is there an advantage to the PFS in terms of practice dynamics in storing the drug with that presentation?

    再更具體一點談診所端的運作:由於醫師端空間非常有限、冰箱用來存放藥品的空間也有限,PFS 這種劑型在藥品存放的診所動態上是否有優勢?

  • Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

    Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

  • Thank you, Yigal. Those are excellent questions, and the PFS will make a huge difference for us. And we have, of course, our Chief Medical Officer with us here, Caroline, to speak a little bit more towards that.

    謝謝你,Yigal。這些問題非常好,而 PFS 對我們會帶來巨大的改變。當然,我們的首席醫療長 Caroline 也在現場,請她就此再多補充一些。

  • Caroline Baumal - Chief Medical Officer

    Caroline Baumal - Chief Medical Officer

  • Thank you. So the prefilled syringe is really a practice-enabling innovation, and this is going to offer convenience and efficiency to retina physicians. And from my experience as a clinician and also from being heavily involved in development of our prefilled syringe, this is going to support the ease of clinical use in patients with geographic atrophy. So we really think that this is going to be transformative for physicians and their patients.

    謝謝。預充式注射器確實是一項能夠促進臨床實務運作的創新(practice-enabling innovation),將為視網膜科醫師帶來便利性與效率。以我作為臨床醫師的經驗,以及我深度參與我們預充式注射器的開發來看,這將有助於提升地圖狀萎縮(geographic atrophy)患者在臨床使用上的便利性。因此我們確實認為,這將對醫師及其患者帶來具變革性的影響。

  • When it comes to specifics about the design, I think that retina physicians put their input heavily into how we design this, including the box, the complete package, and we'll be very, very pleased with how it fits into the refrigerators. We also have some other things that will be helping be transformative for SYFOVRE with renewed growth, and that's functional OCT, which was mentioned in the call.

    就設計細節而言,我認為視網膜科醫師在我們的設計上提供了大量意見,包括外盒、完整包裝等;而且大家會對它如何放入冰箱感到非常、非常滿意。此外,還有一些其他因素也將推動 SYFOVRE 恢復成長並帶來變革性影響,其中之一是在電話會議中提到的功能性 OCT。

  • Operator

    Operator

  • Salveen Richter, Goldman Sachs.

    Salveen Richter,高盛(Goldman Sachs)。

  • Salveen Richter - Analyst

    Salveen Richter - Analyst

  • I was wondering if you could provide any further color on the recent improvement in co-pay dynamics for SYFOVRE and how you think about the quarter-over-quarter cadence of sample use and kind of the sales trajectory as you input this into your trajectory?

    我想請問你是否能就 SYFOVRE 近期自付額(co-pay)動態改善提供更多說明?以及在你們把這些因素納入預期軌跡時,你們如何看待樣品使用量在季度間的節奏,以及整體銷售走勢?

  • Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

    Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

  • Thank you so much, Salveen. Tim, can you elaborate?

    非常感謝你,Salveen。Tim,你可以再補充說明嗎?

  • Timothy Sullivan - Chief Financial Officer, Treasurer

    Timothy Sullivan - Chief Financial Officer, Treasurer

  • Sure. So as you probably saw, Salveen, the Patient Assistance Organization is open for reimbursement for co-pay assistance with geographic atrophy patients. At this time, we don't really have any sense of what that means in terms of dynamics from a free goods perspective. As you'll recall, last year, we had 12% to 14% fluctuating on a quarterly basis. But really, what this represents is an important advance for the patients who have been unable to pay for their treatment in geographic atrophy.

    當然。Salveen,如你可能已看到的,患者援助組織(Patient Assistance Organization)已開放針對地圖狀萎縮患者的自付額補助進行給付/報銷。目前我們其實還無法判斷,這對於免費供貨(free goods)角度的動態意味著什麼。你會記得去年我們的比例在季度間約有 12% 到 14% 的波動。但更重要的是,這代表對那些先前無法負擔地圖狀萎縮治療費用的患者而言,是一項重要進展。

  • Operator

    Operator

  • Colleen Kusy, Baird.

    Colleen Kusy,Baird。

  • Colleen Kusy - Analyst

    Colleen Kusy - Analyst

  • Congrats on all the progress. I realize for the nephrology Phase 3 studies are just recently coming up and running now, but any color you can provide on the expectations for enrollment there? Do any of these centers have preexisting experience with EMPAVELI? Just how that enrollment might pan out.

    恭喜你們取得所有進展。我知道腎臟科的第三期研究才剛開始啟動與運行,但你們能否就那邊的收案(enrollment)預期提供一些補充?這些中心是否有既有使用 EMPAVELI 的經驗?收案可能會如何展開?

  • Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

    Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

  • Thank you so much, Colleen, for that question. So we're very excited about these two Phase 3 clinical trials in FSGS and DGF, where we think EMPAVELI's potential can make a huge difference as it did in C3G and IC-MPGN. It's a little bit early to give projections on what the enrollment will look like, but the excitement around kind of continuing the trajectory in the kidney is very strong.

    非常感謝你,Colleen,謝謝這個問題。我們對於在 FSGS 與 DGF 進行的兩項第三期臨床試驗感到非常興奮;我們認為 EMPAVELI 的潛力能帶來巨大差異,就像它在 C3G 與 IC-MPGN 中所展現的一樣。目前要對收案情況做出預測還稍早,但對於在腎臟領域延續這條發展軌跡的期待與熱度非常高。

  • What really stood out from the VALIANT study is the exquisite target engagements and the control of the complement pathways that we see in the glomerulus, which we believe will translate in a similar efficacy profiles in these conditions.

    VALIANT 研究中真正突出的,是我們看到在腎小球中極佳的靶點結合(target engagement)以及對補體途徑的控制;我們相信這將在這些適應症中轉化為相近的療效特徵。

  • Operator

    Operator

  • Phil Nadeau, TD Cowen.

    Phil Nadeau,TD Cowen。

  • Philip Nadeau - Analyst

    Philip Nadeau - Analyst

  • We wanted to focus on SYFOVRE revenue trends for Q1 and 2026. Tim, putting your comments together, it sounds like you expect typical seasonal factors. For Q1 last year, sales were down $37 million quarter over quarter in Q1 '25 versus Q4 '24, although there was a big impact of free product in that downtick. So how will the seasonal factors in Q1 of '26 compare to Q1 of '25?

    我們想聚焦在 SYFOVRE 於第一季與 2026 年的營收趨勢。Tim,把你的評論綜合起來聽起來,你預期會有典型的季節性因素。去年第一季,銷售額相較前一季下降了 3,700 萬美元(也就是 2025 年第一季相較 2024 年第四季),不過那次下滑中免費產品的影響很大。那麼 2026 年第一季的季節性因素,會如何與 2025 年第一季相比?

  • And then more generally for 2026, it sounds like you guys are suggesting relatively stable revenue for SYFOVRE. So I want to make sure I understand that we should be modeling something, full year 2026 similar to full year 2025?

    另外更一般性地談 2026 年,聽起來你們是在暗示 SYFOVRE 的營收相對穩定。所以我想確認我的理解:我們是否應該把 2026 全年建模為與 2025 全年相近的水準?

  • Timothy Sullivan - Chief Financial Officer, Treasurer

    Timothy Sullivan - Chief Financial Officer, Treasurer

  • Sure. So yeah, I think the one thing to remember, there are a couple of seasonal dynamics in the first quarter, one of which we tried to manage a little bit. So as you'll recall, last year, we had a fourth quarter spike in revenue that was as a result of some inventory build across the channel. So that included at the physician offices as well as the distributor.

    當然。所以是的,我認為需要記住的一點是,第一季有幾個季節性動態,其中之一我們已嘗試稍微加以管理。如你所記得的,去年我們第四季營收出現一波高峰,原因是通路端進行了一些庫存建立。這包括醫師診所端以及經銷商端。

  • We really did our best to manage that this year. So we think there may be a bit of a modest swing in the first quarter, but much more muted than last year. We also typically have some seasonal dynamics like weather and reverifications in the first quarter.

    今年我們確實盡最大努力去管理這件事。因此我們認為第一季可能會有些許溫和的波動,但會比去年明顯收斂。此外,我們第一季通常也會有一些季節性因素,例如天氣以及重新驗證(reverification)。

  • So bearing that in mind, we think across the year, that's the main seasonal quarter for us. There is a little bit at the end in the fourth quarter. But as you rightly point out, we expect sort of a modest cadence to growth over the course of the year.

    因此考量到這些因素,我們認為就全年而言,第一季是我們最主要的季節性季度。第四季末也會有一點點。但正如你所指出的,我們預期全年成長節奏會是相對溫和、循序的。

  • Operator

    Operator

  • Annabel Samimy, Stifel.

    Annabel Samimy,Stifel。

  • Jayed Momin - Analyst

    Jayed Momin - Analyst

  • This is Jayed on for Annabel. I just want to revisit the SYFOVRE doses delivered. It was flat quarter-over-quarter, I think you mentioned due to some seasonality. But there was an improved split favoring commercial doses. Agnostic of the pay -- the co-pay assistance funds coming back, do you expect that split to be more favorable towards commercial doses going forward in 2026?

    我是代替 Annabel 的 Jayed。我想再回到 SYFOVRE 的交付劑量(doses delivered)。它在季度對季度是持平的,我想你提到是因為一些季節性因素。但商業劑量(commercial doses)的占比拆分有所改善、較為有利。不考慮共同支付(co-pay)補助資金回流與否,你是否預期到 2026 年之後,這個拆分會持續更有利於商業劑量?

  • Timothy Sullivan - Chief Financial Officer, Treasurer

    Timothy Sullivan - Chief Financial Officer, Treasurer

  • Sure. So thanks for the question. So what we really felt happened in the fourth quarter was a touch of seasonality. When you look at the amount of doses we had, it was 89,000, and sort of there are roughly 90 days in a quarter. We had a couple of a longer holiday stretch that may have impacted things. So it was really not a significant change from a commercial doses perspective in the context of that seasonality in our view.

    當然。謝謝你的問題。我們認為第四季真正發生的是些許季節性影響。你看我們的劑量數是 89,000,而一個季度大約有 90 天。我們遇到了一段較長的假期,可能對數據造成影響。因此在我們看來,在這種季節性背景下,從商業劑量的角度並沒有出現顯著變化。

  • But from the free goods perspective, we saw a range of 12% to 14% over the course of 2025. That bounced around. And so this was, I think, pretty much in line with what we expected in the fourth quarter. As you may recall, sometime in the third quarter, the patient co-pay assistance organization was open for existing patients, and that may have led to a small downtick in the total free goods in the fourth quarter, but it's really hard to say.

    但從免費供藥(free goods)的角度來看,我們在 2025 年全年看到的區間約為 12% 到 14%。這個比例有上下波動。因此我認為第四季的情況基本符合我們的預期。如你可能記得的,在第三季的某個時間點,病患共同支付補助機構對既有病患重新開放,這可能導致第四季免費供藥總量小幅下降,但其實很難下定論。

  • Operator

    Operator

  • Ellie Merle, Barclays.

    Ellie Merle,Barclays。

  • Eliana Merle - Equity Analyst

    Eliana Merle - Equity Analyst

  • Two for me. I guess, what are you looking to see in the Phase 2 data, SYFOVRE in combo with APL-3007 next year? And how you're thinking about what would be meaningful there?

    我有兩個問題。我想問的是,明年 SYFOVRE 與 APL-3007 聯合用藥的第二期(Phase 2)數據,你們希望看到什麼?以及你們如何思考什麼樣的結果才算有意義?

  • And then just a clarification on the C3G IC-MPGN comments. The 50% penetration that you mentioned, I'm sorry if I missed this. But I guess, is this the base case that you'll treat 50%? Or are you saying that half the population will become challenging to treat? Just trying to understand that 50% comment.

    另外想釐清一下你們對 C3G 與 IC-MPGN 的評論。你提到的 50% 滲透率(penetration),抱歉如果我漏聽了。但我想確認,這是你們的基本情境(base case)是治療 50% 的患者嗎?還是你在說有一半的人口會變得難以治療?只是想理解這個 50% 的說法。

  • Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

    Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

  • Thank you, Ellie. Great hearing you. So the GALLOP study is a study we're really excited about. What we do there is a subcutaneous injection with an siRNA product against C3. And that lowers the systemic levels of C3 by approximately 90%. What that does is it translates to actually a lowering of the C3 levels in the eye as well. And it gives a stchiometric advantage to SYFOVRE to do its job.

    謝謝你,Ellie。很高興聽到你的聲音。所以 GALLOP 研究是我們非常期待的一項研究。我們在該研究中使用針對 C3 的 siRNA 產品進行皮下注射。這會將全身性的 C3 水平降低約 90%。其結果是也會降低眼內的 C3 水平。並且在化學計量(stoichiometric)上為 SYFOVRE 發揮作用提供優勢。

  • We believe that this study, if successful, will allow us to treat every three months instead of every two months, and to increase the efficacy, which is already important, of course, from SYFOVRE to numbers well above that. What well above that means, we will define at a later time point. But I think, again, kind of really, really exciting study for us, where I think we can again change the paradigm in geographic atrophy as we have done before.

    我們相信如果這項研究成功,將使我們能夠改為每三個月治療一次,而不是每兩個月一次,並提升療效——當然,SYFOVRE 目前的療效已經很重要——把數據提升到明顯更高的水準。至於「明顯更高」具體代表什麼,我們會在較後面的時間點再做定義。但我認為,這對我們而言是一項非常、非常令人振奮的研究,我們有機會再次改變地圖狀萎縮(geographic atrophy)的治療典範,就像我們之前所做的一樣。

  • As it relates to the C3G and IC-MPGN population, so we said we believe that up to 50% of the epidemiology would be patients that could end up being treated with EMPAVELI. What I think is important in that context is, again, that we -- I think we're very good at having a conservative estimate of the epidemiology for C3G and IC-MPGN. It is noteworthy that our only competitor in this space has an epi that is meaningfully higher.

    至於 C3G 與 IC-MPGN 的族群,我們表示我們相信流行病學(epidemiology)中最多可達 50% 的患者,最終可能會使用 EMPAVELI 治療。我認為在這個脈絡下重要的是,我們——我想我們在對 C3G 與 IC-MPGN 的流行病學估算上相當保守。值得注意的是,我們在這個領域唯一的競爭對手,其流行病學估算明顯更高。

  • And the fact that we have more than 5% penetration in the fourth quarter, which means that we had a very, very strong launch, among the strongest launches in rare diseases. And maybe a conservative epi on our side or a combination of both. So again, we feel very good with where EMPAVELI is headed with what we did in Q4 and the trend that we continue to see as this launch progresses.

    而且我們在第四季的滲透率超過 5%,這代表我們的上市表現非常、非常強勁,是罕見疾病領域中最強的上市之一。這可能意味著我們這邊的流行病學估算較保守,或兩者兼而有之。因此,我們對 EMPAVELI 的發展方向感到非常樂觀,基於我們在第四季所做的成果,以及隨著上市推進我們持續看到的趨勢。

  • Operator

    Operator

  • Lachlan Hanbury-Brown, William Blair.

    Lachlan Hanbury-Brown,William Blair。

  • Lachlan Hanbury-Brown - Analyst

    Lachlan Hanbury-Brown - Analyst

  • I guess for EMPAVELI, you've previously talked about there being an initial bolus of patients and then it sort of settles down into more of a steady state, monthly or quarterly growth in new patients. I'm wondering, sort of where are you at that? Are you through that bolus and into the steady state now? Or are you still working through some of that initial bolus of patients that you're expecting? And maybe you reach steady state later this year?

    我想就 EMPAVELI 問一下,你們之前談到上市初期會有一波(initial bolus)病患,之後會回到較穩態(steady state)的狀態,新病患以每月或每季的速度穩定成長。我想問你們目前大概處於哪個階段?你們已經走過那一波、進入穩態了嗎?還是仍在消化你們預期的那一波初期病患?也許要到今年稍晚才會進入穩態?

  • Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

    Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

  • Yeah. Thank you, Lachlan. I will hand that over to David Acheson to answer.

    是的。謝謝你,Lachlan。我把這題交給 David Acheson 來回答。

  • David Acheson - Executive Vice President of Commercial

    David Acheson - Executive Vice President of Commercial

  • Thanks for the question. So yeah, like we talked about last year in the Q3 launch through Q4, that bolus of patients typically hits early in the launch and get on product shortly after the launch. And we saw that happen in the fourth quarter, which was great to see.

    謝謝你的問題。是的,正如我們去年所談到的,從第三季上市到第四季,這一波病患通常會在上市初期出現,並在上市後不久開始用藥。我們在第四季確實看到這件事發生,這點很令人高興。

  • Now we're at that steady state place that we talked about in prepared remarks and what Cedric mentioned in the opening portion of some of the questions here. So I would be confident in the continued steadiness of what we're going to see moving forward.

    現在我們已經處於我們在事先準備的講稿中所提到的那個穩態階段,也就是 Cedric 在前面部分問題開場時提到的。因此我對未來我們將看到的持續穩定性很有信心。

  • Operator

    Operator

  • Judah Frommer, Morgan Stanley.

    Judah Frommer,Morgan Stanley。

  • Judah Frommer - Analyst

    Judah Frommer - Analyst

  • Maybe just one on the commentary around the ability to fund yourselves through to profitability. Just curious how pipeline could impact the timing and trajectory of that, specifically maybe 9099 and 3007, what are the pushes and pulls there that could move that profitability closer or further out?

    我想問一個關於你們提到能夠自我資助直到達到獲利(profitability)的評論。我好奇研發管線(pipeline)會如何影響達到獲利的時間點與路徑,特別是 9099 和 3007,哪些因素可能推動或拉動(pushes and pulls)使獲利更早或更晚?

  • Timothy Sullivan - Chief Financial Officer, Treasurer

    Timothy Sullivan - Chief Financial Officer, Treasurer

  • Yeah. Thank you, Judah. That's a great question. At least for the moment, we've incorporated all of that into our thinking when we talk about the fact that we may have a small increase in total operating expenses this year, as you'll see in 2024 and 2025, it was pretty flat overall. We have a -- may have a solid increase over the course of this year with the -- our FSGS study and our DGF study really ramping up and then some of these new programs that you mentioned like the Beam program coming online towards the end of the year in terms of potential larger cost structure.

    是的。謝謝你,Judah。這是個很好的問題。至少就目前而言,當我們談到今年總營運費用可能小幅增加時,我們已把這些都納入考量;如你所見,2024 與 2025 年整體相當持平。今年隨著我們的 FSGS 研究與 DGF 研究真正加速推進,以及你提到的一些新計畫(例如 Beam 計畫)在年底前後上線,成本結構可能在今年期間出現相當幅度的增加。

  • But ultimately, we've been pretty good about managing our operating expenses, and it really comes down to the revenue growth that will make that happen. We look at the world at least today from an operating expense and net revenue perspective. And if you look, taking -- adding back stock-based compensation, we've been pretty close to an operating adjusted EBITDA neutral level over the last year, and we expect that to come more into focus over the course of this year.

    但歸根結底,我們在管理營運費用方面一直做得相當不錯,而這真正取決於能夠帶動這一切的營收成長。至少就目前而言,我們從營運費用與淨營收的角度來看待整體情況。而如果你看——把以股票為基礎的薪酬加回來,我們在過去一年一直相當接近營運調整後 EBITDA 持平的水準,我們也預期在今年的進程中,這一點會更加清晰。

  • Operator

    Operator

  • Douglas Tsao, HC Wainwright.

    Douglas Tsao,HC Wainwright。

  • Douglas Tsao - Equity Analyst

    Douglas Tsao - Equity Analyst

  • Just on SYFOVRE, David, just a couple of questions. I think you indicated there was sort of an initiative to help patients sort of end up on the right plan which sort of improves their coverage of SYFOVRE. I'm just curious sort of as you come into the new year, if you've sort of seen meaningful progress on that.

    關於 SYFOVRE,David,我有幾個問題。我想你提到有一項倡議,協助病患最後能選到合適的方案,從而改善他們對 SYFOVRE 的給付涵蓋。我只是好奇,進入新的一年後,你們是否已經看到這方面有顯著進展。

  • And then also, I'm just curious in terms of the free goods, are you seeing those patients sort of typically sort of get dosed with free goods and then they see that they can't get covered or can't get patient assistance and drop off? Or are you seeing sort of a persistence of it? I'm just sort of trying to understand that in terms of understanding sort of how patients are coming in and sort of identification for the market.

    另外,我也想了解一下免費供藥(free goods)方面:你們是否看到這些病患通常先使用免費供藥接受給藥,之後發現無法獲得保險給付或無法取得病患協助而流失?還是你們看到的是某種程度的持續性?我想從病患進入與市場辨識的角度來理解這一點。

  • Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

    Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

  • Thank you, Doug. David will answer the question on SYFOVRE, and I will -- the first question, and I will then talk a little bit about the free goods.

    謝謝你,Doug。David 會回答關於 SYFOVRE 的問題——第一個問題——然後我會再談一點關於免費供藥。

  • David Acheson - Executive Vice President of Commercial

    David Acheson - Executive Vice President of Commercial

  • Doug, thanks for the question. So on the reverification piece and just kind of patients coming over on insurance plans and what we did last year. So we put a lot of effort in last year with our field reimbursement team to make sure that we can help offices get educated on which plans would be specific to patients that have a gap, right, where they couldn't get covered for a geographic atrophy treatment or specifically, SYFOVRE. So we did a lot of work on that.

    Doug,謝謝你的提問。關於重新驗證(reverification)這一塊,以及病患在保險方案之間的轉換,還有我們去年做了什麼。去年我們投入了大量心力,透過我們的外勤給付支援團隊,確保能協助診所端了解:對於那些存在缺口的病患——也就是在某些地區無法獲得地圖狀萎縮(geographic atrophy)治療,或特別是 SYFOVRE 給付涵蓋的病患——哪些方案更適合他們。所以我們在這方面做了很多工作。

  • Our Apellis Assist, which is our hub, has also been integral and playing a part of making sure education to both the patients and the offices during the reverification period of their insurance, which happened in the fourth quarter coming into this year, helps them understand where they've got opportunities for benefit -- for treatment for benefit and payment. And all of that happened coming into this year.

    我們的 Apellis Assist(也就是我們的支援中心/hub)也扮演了關鍵角色,確保在保險重新驗證期間——也就是第四季、銜接到今年——能同時對病患與診所端進行教育,幫助他們了解在哪些地方有機會取得給付——也就是治療的給付與付款。而這些工作都是在進入今年之前完成的。

  • And I can tell you, the reverification process is winding down. It's been relatively smooth. I cannot tell you how many patients actually changed plans or moved over. But we did what we could to continue to educate so people had access to additional information.

    我可以告訴你,重新驗證流程正在接近尾聲。整體而言相對順利。我無法告訴你實際有多少病患更換了方案或轉移到其他方案。但我們已盡力持續進行教育,讓大家能取得更多資訊。

  • And I'll hand it back over to Cedric.

    我把時間交回給 Cedric。

  • Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

    Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

  • Thank you, David. Well, as it relates to the free goods, I kind of want to highlight something that is really important, and that is that in 2025, we made a deep commitment as a company to support the retina practices to deal with, at the end of the day, a lot of patients being in a position where they could not afford the co-pay on their products and to make sure that these patients would not go without treatment, right?

    謝謝你,David。關於免費供藥,我想強調一件非常重要的事:在 2025 年,我們公司做出深度承諾,支持視網膜專科診所,因為最終有許多病患面臨無法負擔產品自付額(co-pay)的情況;我們要確保這些病患不會因此而無法接受治療,對吧?

  • So that is our medical commitment to patients, and that is what we did throughout the year last year. But we will always continue to do when it is needed. So that is really important and will continue to be important for us.

    這就是我們對病患的醫療承諾,也是我們去年一整年所做的事。而且只要有需要,我們也會一如既往地持續這麼做。所以這一點非常重要,對我們而言也將持續重要。

  • I think within the context of next year as well, I think it is hard to overstate how impactful the disruption was on the workflow in the retina practices when this occurs, right? So that is something that needs -- had to find a new place of settlement that was important.

    我想在明年這個脈絡下也一樣,很難誇大當這種情況發生時,對視網膜專科診所工作流程造成的干擾有多大影響。因此,這需要——也必須——找到一個新的平衡點,這很重要。

  • And during that period, there was inevitably kind of, I would say, a lowering of how many new patients would come on treatment with geographic atrophy because within these retina practices, that is easy to essentially punt, right? So that dynamic is also something that you should expect to see change over time. I think what is really important and gratifying to see right now is that within the retina world, we're starting to find a new cadence and a new place of stability after what was a very difficult year for these physicians and patients.

    在那段期間,不可避免地,我會說,新開始接受地圖狀萎縮治療的病患數量有所下降,因為在這些視網膜專科診所裡,這件事很容易就被先擱置、延後處理,對吧?所以你也應該預期,這種動態會隨時間而改變。我認為現在真正重要、也令人欣慰的是:在視網膜領域,在對醫師與病患而言都非常艱難的一年之後,我們開始找到新的節奏與新的穩定狀態。

  • Douglas Tsao - Equity Analyst

    Douglas Tsao - Equity Analyst

  • Great. And it's great to hear about the commitment to providing drug to patients.

    很好。也很高興聽到你們承諾為病患提供藥物。

  • Operator

    Operator

  • Derek Archila, Wells Fargo.

    Derek Archila,Wells Fargo。

  • Derek Archila - Analyst

    Derek Archila - Analyst

  • You made some comments on kind of the patient pipeline for EMPAVELI in C3G and IC-MPGN. And I guess, what level of visibility do you have there? Is it as granular as understanding where the patients are at certain sites, outreach of those patients?

    你們提到 EMPAVELI 在 C3G 與 IC-MPGN 的病患管線(patient pipeline)的一些看法。我想問的是,你們在這方面的能見度到什麼程度?是否細緻到能了解各個據點的病患狀態、以及對這些病患的外展聯繫(outreach)情況?

  • And then just a second question on PFS. Just kind of curious, is it more of expand the market? Or is it also share gains against the other competitor?

    另外第二個問題是關於 PFS(預充式注射器)。我想了解,這更像是擴大市場?還是也包含相對於另一個競品的市占提升?

  • Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

    Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

  • Thank you so much, Derek. Well, first of all, as it relates to the pipeline, I think that is one of the most -- one of the more gratifying aspects of the launch that we have seen. First of all, of course, there was the epidemiology, which, as you all know, was difficult to estimate and feeling that we really kind of hit the bullseye in terms of estimating that and arguably conservatively estimating that. Then, of course, the very good -- one of the best rare disease launches that we are having in the kidney here with that penetration within the first full quarter.

    非常感謝你,Derek。首先,關於管線,我認為這是我們在上市推進中看到最——也是更令人欣慰的面向之一。首先,當然是流行病學(epidemiology)估算;如各位所知,這很難估計,而我們覺得自己在估算上確實命中靶心,甚至可以說是偏保守地估計。接著當然是非常好的表現——在腎臟這個領域,我們正在進行的可說是最好的罕見疾病上市之一,在第一個完整季度就達到那樣的滲透率。

  • But then, as you mentioned, also the pipeline. So if you take the number of patients that we actually identified, which then flow into start forms and from start forms into being on treatment, that upstream pipeline today is larger than it was before the launch. In spite of course, many of these patients now having transitions to start forms and being on full treatment. So that tells us that, again, we got the epi rate. We continue to identify these patients and why we expect this launch to be one of steady growth.

    但如你所提到的,還有管線。如果你看我們實際辨識到的病患數,這些病患接著會進入啟動表單(start forms),再從啟動表單轉為開始治療;目前這個上游管線比上市前還要更大。儘管當然,其中許多病患現在已經轉入啟動表單並進入完整治療。所以這再次告訴我們:我們的流行病學比率估得很準。我們也持續辨識到這些病患,這就是為什麼我們預期這次上市將會是穩健成長的一次。

  • And then as it relates to your second question with the prefilled syringe, I think it will be a very important driver of share. We have plenty of examples from the wet AMD space with anti-VEGF products, where it has been proven over and again that having a prefilled syringe on the market makes a very important competitive advantage for a product. That is one that we are working towards. Of course, we expect our competitor at some point to come out with a prefilled syringe as well. But right now, we have a head start that we're very happy with and that will allow us to position ourselves well.

    至於你的第二個問題——預充式注射器——我認為它會是推動市占的一個非常重要的驅動因素。我們在濕性 AMD 領域、抗 VEGF 產品上有很多例子,一再證明:市場上若有預充式注射器,會為產品帶來非常重要的競爭優勢。這也是我們正在努力達成的方向。當然,我們也預期競爭對手在某個時間點也會推出預充式注射器。但就目前而言,我們有一個讓我們非常滿意的領先優勢,這將使我們能更好地定位自己。

  • As it relates to share, it will also make a difference. The fact that you fit better into the workflow of the retina practice makes it much easier for physicians to treat these patients, makes it also much easier, quite frankly, for physicians to just try the products, right? I mean, it is not -- instead of taking something, having to draw it from vial in -- through a filter needle into a syringe, et cetera, you take it out of the fridge and you try it, right? So important differences, and I don't know, Caroline, if you want to elaborate on that, but we're very pleased with where we are.

    就市占而言,它也會帶來差異。因為它更符合視網膜專科診所的工作流程,讓醫師更容易治療這些病患;坦白說,也讓醫師更容易去嘗試這個產品,對吧?我的意思是,與其要從小瓶中抽取、透過濾針抽入注射器等等,你只要從冰箱拿出來就能試用,對吧?所以這些都是重要差異;我不知道 Caroline 你是否想補充,但我們對目前的進展非常滿意。

  • Caroline Baumal - Chief Medical Officer

    Caroline Baumal - Chief Medical Officer

  • Yeah. This is a real innovation, and this will be highly meaningful to physicians to have this way to treat their patients efficiently. So I speak from my personal experience and what I've heard from colleagues that I think that this will help to expand the market for geographic atrophy.

    是的。這是一項真正的創新,對醫師而言,能以這種方式有效率地治療病患將具有非常重大的意義。因此,根據我個人的經驗以及我從同事那裡聽到的,我認為這將有助於擴大地圖狀萎縮(GA)的市場。

  • Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

    Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

  • Thank you, Caroline. And worth noting is that the prefilled syringe that we have from a CMC perspective, from a quality, from -- is absolutely has been spectacular for us and outpaced our own high internal expectations. We're really happy not just with the pace at which we're bringing into the market, but also with the quality of the prefilled syringe.

    謝謝你,Caroline。另外值得一提的是,從 CMC 的角度、從品質的角度來看,我們的預充式注射器——可以說——對我們而言表現非常出色,甚至超越了我們內部原本很高的期待。我們不僅對導入市場的速度感到非常滿意,也對預充式注射器的品質感到非常滿意。

  • Operator

    Operator

  • Ryan Deschner, Raymond James.

    Ryan Deschner,Raymond James。

  • Unidentified Participant

    Unidentified Participant

  • This is Anthony on for Ryan. So we wanted to ask, can you walk us through how retina specialists can potentially use OCT-F in their practices, how this could increase the size of the GA market? And then if you have like an approximate time line for when you anticipate having appreciable amounts of real-world OCT-F data for analysis? And if possible, I have a follow-up.

    我是代替 Ryan 發言的 Anthony。我們想請教,您能否帶我們了解一下視網膜專科醫師在臨床上可能如何使用 OCT-F,以及這如何能增加 GA 市場的規模?另外,若您方便的話,您預期何時能取得足量、可供分析的真實世界 OCT-F 資料的大致時間表?如果可以的話,我還有一個追問。

  • Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

    Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

  • Thank you so much, Anthony. Well, we're touching on Caroline's favorite subject here. So for those on the call not familiar with OCT-F, OCT-F is functional OCT, and it is a technology that we developed in collaboration with University of Bonn in Germany, where we used our -- what is the largest data set of microperimetry data ever generated in the retina, where we use that technology to essentially take an OCT and translate an OCT image into what a real functional mapping of the retinas. In other words, what is the retinal sensitivity in the patient across the retina.

    非常感謝你,Anthony。嗯,我們在這裡正好談到 Caroline 最喜歡的主題。對於電話會議中不熟悉 OCT-F 的朋友,OCT-F 是功能性 OCT(functional OCT),這是我們與德國波恩大學合作開發的一項技術;我們使用了——可說是視網膜領域迄今所產生最大規模的微視野檢查(microperimetry)資料集——藉由這項技術,基本上是取得一張 OCT,並將 OCT 影像轉換為視網膜真正的功能性地圖。換句話說,就是病患在整個視網膜範圍內的視網膜敏感度為何。

  • And what really stands out when you analyze patients with geographic atrophy over time is the impressive loss of retinal sensitivity that these patients experience. And from a timing perspective, what you should expect to see this year -- and it started at Angiogenesis two weeks ago -- is that we will redefine for retina specialists and for family members of patients, what it means to have this disease.

    而當你長期分析地圖狀萎縮病患時,最突出的就是這些病患所經歷的視網膜敏感度顯著下降。從時程角度來看,今年你們應該會看到——其實兩週前在 Angiogenesis 會議上就已開始——我們將為視網膜專科醫師以及病患家屬重新定義,罹患這種疾病究竟意味著什麼。

  • And why is this so important? Because right now, a lot of people believe that geographic atrophy happens on the border of a lesion. And that is not the case. It is really a pan-retinal neurodegenerative condition, and we can now image that. And commensurate with that, of course, we can image and quantifiably visualize what the benefit is of being on treatment with SYFOVRE. In the first step this year, we will be focused on, again, as I mentioned, raising the awareness around how impactful geographic atrophy is on patients.

    那為什麼這麼重要?因為目前很多人認為地圖狀萎縮是發生在病灶的邊界。但事實並非如此。它其實是一種全視網膜的神經退化性疾病,而我們現在可以把它影像化。與此相對應地,當然,我們也能影像化並以可量化的方式視覺化呈現使用 SYFOVRE 治療所帶來的效益。今年的第一步,我們將聚焦於——如我所提到的——提升外界對地圖狀萎縮對病患影響有多大的認知。

  • And then it becomes our mission to make this available in the retina practice so that a physician in a one-on-one interaction with the patient can actually do that analysis, assess the patient and again, track what the benefit is of being on treatment with SYFOVRE to that patient. Caroline is in love with this technology, speaks about it at every retina conference. And maybe you want to add a couple of words?

    接著,我們的使命就是讓這項技術能在視網膜門診中使用,讓醫師在與病患一對一互動時,能實際進行分析、評估病患,並再次追蹤該病患使用 SYFOVRE 治療所帶來的效益。Caroline 非常熱愛這項技術,在每一場視網膜會議都會談到它。也許你想再補充幾句?

  • Caroline Baumal - Chief Medical Officer

    Caroline Baumal - Chief Medical Officer

  • Physicians are really excited for this technology finally to have a way to link structure to function. This was shown at our recent presentation at Angiogenesis, and I had multiple people reaching out to me after. But what I would say is that this will help with earlier diagnosis of GA. It will help position -- support the patient's journey. It will help physicians better understand this disease.

    醫師們對這項技術感到非常興奮,因為終於有方法能把結構與功能連結起來。這在我們最近於 Angiogenesis 的發表中已展示,我之後也收到好幾位人士主動聯繫我。但我想說的是,這將有助於更早診斷 GA。它將有助於定位——並支持病患的就醫旅程。它也將幫助醫師更好地理解這個疾病。

  • And we expect this to support adoption of SYFOVRE, which is the currently approved agent with every other month dosing, support their use in patients and help keep patients on their treatment schedule with up to every other month by showing them and showing their family members how they're doing, we also hope that it helps highlight other diseases, including wet AMD and other things that we're evaluating as a research tool.

    我們預期這將支持 SYFOVRE 的採用;SYFOVRE 目前是已核准、可採每兩個月一次給藥的藥物,能支持醫師在病患中的使用,並透過向病患及其家屬展示他們的狀況,幫助病患依照治療時程、最多以每兩個月一次的頻率持續治療。我們也希望它能協助凸顯其他疾病,包括濕性 AMD,以及我們正在以研究工具評估的其他項目。

  • Operator

    Operator

  • Douglas MacPherson, Mizuho.

    Douglas MacPherson,Mizuho。

  • Douglas MacPherson - Analyst

    Douglas MacPherson - Analyst

  • I'm interested in the sort of competitive dynamics of the market. Firstly, are you seeing the complement inhibitor class to treat GA, seeing that hold steady or perhaps growing modestly? And then I think you're holding pretty solid at 60% market share. As far as new patient starts, what proportion are you seeing versus competitor? And have you seen any impact of the five-year GALE update in November? You see any impact on that on new patient starts or on compliance?

    我對市場的競爭動態很感興趣。首先,您是否看到用於治療 GA 的補體抑制劑(complement inhibitor)這一類別維持穩定,或是可能小幅成長?另外,我認為你們的市占率相當穩固,約在 60%。就新病患開始治療而言,你們看到的比例相較於競品如何?以及,11 月的五年期 GALE 更新是否帶來任何影響?你們是否看到它對新病患開始治療或對依從性(compliance)有任何影響?

  • Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

    Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

  • Thank you, Doug. Good hearing from you. So as a class, we believe that -- it's hard to believe that it's still the early days of what can be done for patients with geographic atrophy. And of course, with the differentiation of our product and the enormous amount of data that we've generated, including over, as you mentioned, the full five-year period, we are really well positioned to continue to shine competitively.

    謝謝你,Doug。很高興聽到你的聲音。就整個類別而言,我們認為——很難相信——對於能為地圖狀萎縮病患做些什麼,現在仍處於早期階段。當然,憑藉我們產品的差異化,以及我們所產生的大量數據(包括你提到的完整五年期數據),我們在競爭上具備非常好的定位,能持續展現優勢。

  • I will hand it over to David Acheson to talk a little bit more about market share.

    我把時間交給 David Acheson,請他再多談一些市占率。

  • David Acheson - Executive Vice President of Commercial

    David Acheson - Executive Vice President of Commercial

  • Yeah. Thanks for the question. So you're correct. We're holding steady at 60% market share, which we're confident in. And we feel really good about where we're coming into 2026.

    好的。謝謝你的提問。你說得沒錯。我們的市占率維持在 60%,我們對此很有信心。而且我們對邁入 2026 年的態勢感到非常樂觀。

  • I can tell you that we're really confident in the competitive strength that we have, including the GALE data that we just talked about and came out this week. I think it's important for us to note that nobody else has that data, and it's a big strength for us to have that kind of data with the patients that are in the long-term study. And our focus, quite frankly, is really being disciplined on execution and to continue to innovate with what we're doing with the brand and continue that leadership reinforcement moving forward within the space. So the market share is part of that, but certainly, driving innovation is a part that we'll continue to drive uptake, market growth and our share growth as well.

    我可以告訴你,我們對自身的競爭實力非常有信心,其中包括我們剛剛談到、並在本週公布的 GALE 數據。我認為重要的是要指出,沒有其他人擁有這些數據;對我們而言,能在長期研究中的病患身上取得這類數據是一大優勢。坦白說,我們的重點就是嚴謹地執行,並持續在品牌上推動我們正在做的創新,進一步強化我們在此領域的領導地位。市占率是其中一部分,但推動創新同樣是我們將持續帶動採用、帶動市場成長以及我們市占成長的一環。

  • Operator

    Operator

  • Thank you. I would now like to turn the conference back to Cedric Francois for closing remarks. Sir?

    謝謝。現在我想把電話會議交回給 Cedric Francois 作結語。先生?

  • Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

    Cedric Francois - President, Chief Executive Officer, Co-Founder, Director

  • Thank you very much, and thank you all for your thoughtful questions. We look forward to updating you on our progress, and I believe that we're speaking with many of you later today as well. Thank you so much, and I hope you have a great rest of the day.

    非常感謝,也謝謝各位提出深思熟慮的問題。我們期待向各位更新我們的進展;我也相信今天稍晚我們還會與在座許多人進一步交流。非常感謝,祝各位今天剩下的時間一切順利。

  • Operator

    Operator

  • This concludes today's conference call. Thank you for participating. You may now disconnect.

    今天的電話會議到此結束。感謝各位參與。您現在可以掛線。