Apellis Pharmaceuticals Inc (APLS) 2024 Q2 法說會逐字稿

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the Apellis Pharmaceuticals second-quarter 2024 Earnings conference call. (Operator Instructions). Please be advised, today's call is being recorded.

早安，女士們先生們。感謝您的耐心等待，歡迎參加 Apellis Pharmaceuticals 2024 年第二季財報電話會議。（操作員說明）。請注意，今天的通話正在錄音。

I would now like to hand the conference over to Meredith Kaya, Senior Vice President, Investor Relations and Strategic Finance. Please go ahead.

現在我想將會議交給投資者關係和策略財務高級副總裁梅雷迪思·卡亞 (Meredith Kaya)。請繼續。

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

早安，感謝您加入我們討論 Apellis 2024 年第二季財務表現。與我一起參加電話會議的是共同創辦人兼執行長 Cedric Francois 博士；營運長亞當湯森；首席醫療官 Caroline Baumal 博士；和首席財務官蒂姆·沙利文。

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

在開始之前，請允許我指出，我們將根據我們當前的期望和信念做出前瞻性聲明。這些陳述存在一定的風險和不確定性，實際結果可能有重大差異。我鼓勵您查閱我們向 SEC 提交的文件中討論的風險因素，以了解更多詳細資訊。

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

現在，我將把電話轉給塞德里克。

Thank you, Meredith. And thank you all for joining us this morning. We are in a unique position today with one and the potential for two blockbuster drugs in the market, SYFOVRE and EMPAVELI, both of which are making a meaningful difference for patients.

謝謝你，梅雷迪思。感謝大家今天早上加入我們。今天，我們處於獨特的地位，市場上有一種和兩種具有潛力的重磅藥物：SYFOVRE 和 EMPAVELI，這兩種藥物都為患者帶來了有意義的改變。

Past six months have been a period of continued progress and execution by the Apellis team, but we recognize that there are questions around the competitive landscape for SYFOVRE. Given this, I wanted to share some of my thoughts.

過去六個月是 Apellis 團隊持續進步和執行的時期，但我們意識到 SYFOVRE 的競爭格局存在問題。有鑑於此，我想分享一些我的想法。

SYFOVRE is the market leader in a category with only two available drugs, 1.5 million highly motivated patients and a long runway for continued growth. That said, there has been a lot of focus on near-term dynamics. Our competitor has recently had tailwinds driven by factors such as its new J-Code. They had every incentive to drive demand in new patient starts as much as possible and yet we saw approximately half of new patients choose SYFOVRE.

SYFOVRE 是該類別的市場領導者，該類別只有兩種可用藥物，擁有 150 萬名積極主動的患者，並且還有很長的持續成長空間。也就是說，人們非常關注近期動態。我們的競爭對手最近在其新 J 代碼等因素的推動下取得了順風車。他們有充分的動機盡可能地推動新患者的需求，但我們看到大約一半的新患者選擇 SYFOVRE。

Following last month's successful ASRS meeting, we believe SYFOVRE clinical profile is being viewed favorably by physicians and will drive more growth in new patient starts over time. The SYFOVRE launch has been one of the best launches in recent history, generating over $0.5 billion in sales in its first six quarters and achieving double-digit percentage growth every single quarter.

繼上個月成功召開 ASRS 會議之後，我們相信 SYFOVRE 的臨床概況受到了醫生的青睞，並將隨著時間的推移推動新患者數量的增長。SYFOVRE 的推出是近年來歷史上最好的推出之一，前六個季度的銷售額超過 5 億美元，每季都實現兩位數的百分比成長。

More than 330,000 SYFOVRE injections are estimated to have been administered to patients, and this strong growth is continuing into the second half of the year. The GA market is growing significantly and SYFOVRE has only scratched the surface of its long-term potential. Importantly, the recent ASRS meeting was a strategic turning point for us. Where our focus and our discussions shifted to SYFOVRE strong and differentiated efficacy profile. We have multiple analyses supporting the efficacy of SYFOVRE, and retina doctors are enthusiastic about the totality of these data.

據估計，已有超過 33 萬支 SYFOVRE 注射注射給患者，這種強勁成長動能將持續到今年下半年。GA 市場正在顯著成長，而 SYFOVRE 僅僅觸及了其長期潛力的冰山一角。重要的是，最近的 ASRS 會議對我們來說是一個策略轉捩點。我們的焦點和討論轉向了 SYFOVRE 強大且差異化的功效。我們有多項分析支持 SYFOVRE 的功效，視網膜醫生對這些數據的整體充滿熱情。

The favorable benefit-risk profile of SYFOVRE is becoming clearer to physicians with some key takeaways. One, both monthly and every other month SYFOVRE treatment showed a better efficacy profile than the competitor among patients with non-SYFOVRE GA and both 12 months and 24 months, as detailed in the matching adjusted indirect comparison post -- analysis presented. Note that no head-to-head clinical trials have been performed.

透過一些關鍵要點，SYFOVRE 的有利效益-風險狀況對於醫生來說變得更加清晰。第一，每月一次和每隔一個月SYFOVRE 治療在非SYFOVRE GA 患者以及12 個月和24 個月的患者中都顯示出比競爭對手更好的療效，如匹配調整間接比較後分析中詳細介紹的。請注意，尚未進行頭對頭臨床試驗。

Two, SYFOVRE is clinically proven to offer flexible dosing from day one. Every other month treatment with SYFOVRE provides an even safer and more cost-effective treatment while maintaining its strong efficacy. And three, regarding safety, vasculitis is rare and appears to be a first injection phenomenon. The estimated rate has remained stable at one in 4,000 per first injection.

第二，臨床證明 SYFOVRE 從第一天起就可以提供靈活的劑量。每隔一個月使用 SYFOVRE 進行治療可提供更安全、更具成本效益的治療，同時保持其強大的療效。第三，關於安全性，血管炎很少見，似乎是首次注射現象。估計的發生率一直穩定在每次注射四千分之一。

During the podium presentation at ASRS, the rest committee confirms this estimated rate as agreed that it appears to be only on the first injection. After this meeting, we continue to believe that we are well-positioned to continue growth and further cement our market leadership in GA for many years to come.

在 ASRS 的講台演講期間，其餘委員會確認了這一估計速率，並同意該速率似乎僅在第一次注射時出現。這次會議之後，我們仍然相信，我們處於有利地位，可以在未來許多年繼續成長並進一步鞏固我們在通用航空的市場領導地位。

Our singular focus is to ensure that every GA patient who needs treatment has access to SYFOVRE. This is how we expect SYFOVRE to continue on its path of becoming a multibillion-dollar drug.

我們唯一的重點是確保每位需要治療的 GA 患者都能獲得 SYFOVRE。這就是我們期望 SYFOVRE 繼續走上成為價值數十億美元藥物的道路的方式。

As for the European GA opportunity, we are focused on the CHMP reexamination process and are encouraged by the progress we made throughout the initial review. This was not an unexpected outcome, given that the process was reset back to day 180 of the initial review and therefore led by the original rapporteur. We were encouraged to learn that in this recent opinion, multiple CHMP members disagreed with the negative opinion.

至於歐洲 GA 機會，我們將重點放在 CHMP 複審流程，並對我們在初步審查過程中取得的進展感到鼓舞。這並不是一個意外的結果，因為該流程被重置為初次審查的第 180 天，因此由原始報告員領導。我們很高興獲悉，在最近的意見中，多名 CHMP 成員不同意負面意見。

Additionally, the external advisory experts were aligned on Microperimetry as the best available functional measure of GA. We are humbled by the broad support shown by the European retina community and while we remain conservative in our expectations for the reexamination, we believe we are well-positioned heading into the appeal. To new rapporteurs were recently designated and we continue to expect the final decision to be issued in the Q4 of 2024.

此外，外部諮詢專家一致認為微視野測量法是 GA 的最佳可用功能測量方法。我們對歐洲視網膜界所表現出的廣泛支持感到謙卑，雖然我們對重新審查的期望仍然保守，但我們相信我們在上訴方面處於有利地位。最近指定了新的報告員，我們仍然預計最終決定將在 2024 年第四季發布。

Moving to EMPAVELI, which continues to elevate the standard of care for patients with PNH. EMPAVELI generated $24.5 million in product sales in the Q2. We continue to believe that patients on EMPAVELI are experiencing substantial benefits as demonstrated by its 97% compliance rate. Importantly, we are exploring its potential to expand into new indications and become a best-in-class treatment option for additional high unmet need areas.

轉向 EMPAVELI，它繼續提高 PNH 患者的護理標準。EMPAVELI 第二季的產品銷售額為 2,450 萬美元。我們仍然相信，使用 EMPAVELI 的患者正在體驗到巨大的益處，97% 的依從率就證明了這一點。重要的是，我們正在探索其擴展到新適應症的潛力，並成為其他高未滿足需求領域的一流治療選擇。

The upcoming Phase 3 VALIANT top line readout in C3G and primary IC-MPGN is the next milestone in this process. And we expect to present these data later this month. If the data are positive, we plan to submit a supplemental NDA to the FDA for approval.

即將推出的 C3G 和主要 IC-MPGN 中的第 3 期 VALIANT 頂線讀數是此過程中的下一個里程碑。我們預計將在本月稍後公佈這些數據。如果數據是正面的，我們計劃向 F​​DA 提交補充 NDA 以獲得批准。

Regarding the pipeline, we are advancing multiple earlier-stage development programs, leveraging our core expertise in complement science to fuel the next phase of value creation for Apellis. We look forward to sharing our progress at an upcoming Investor Day towards the end of this year.

關於管道，我們正在推進多個早期開發項目，利用我們在補充科學方面的核心專業知識來推動 Apellis 下一階段的價值創造。我們期待在今年年底即將舉行的投資者日上分享我們的進展。

And finally, from a financial perspective, we are benefiting from the growing product revenue generated by SYFOVRE and EMPAVELI and have actively taken steps to strengthen our balance sheet. We now have a clear line of sight to positive cash flow, allowing us to invest in future growth without having to rely on the capital market.

最後，從財務角度來看，我們受益於 SYFOVRE 和 EMPAVELI 不斷增長的產品收入，並積極採取措施加強我們的資產負債表。我們現在對正現金流有了清晰的認識，使我們能夠投資於未來的成長，而不必依賴資本市場。

Before I turn it over to Adam to discuss our commercial activities, I will close by saying thank you to the patients and physicians who motivate us to develop and bring important treatments to market and to the Apellis team who have shown unbelievable commitment and perseverance in getting these important medicines to patients and to our shareholders, many of whom have stood with us through these dynamic periods and provided a wave range support to us over the years.

在我將其交給Adam 討論我們的商業活動之前，我要感謝那些激勵我們開發並將重要治療方法推向市場的患者和醫生，感謝Apellis 團隊，他們在獲得治療方面表現出了令人難以置信的承諾和毅力。

With that, I will now turn it over to Adam.

有了這個，我現在將把它交給亞當。

Thanks Cedric, and good morning everyone. I will begin with SYFOVRE. With revenue of about $155 million. Sales growth remains strong at more than 12% quarter-over-quarter. In the second year of our products launch, quarterly growth rates at these levels are a strong indicator of longer-term demand. We delivered over 79,000 commercial doses and approximately 5,000 samples of SYFOVRE in the second quarter.

謝謝塞德里克，大家早安。我將從 SYFOVRE 開始。收入約1.55億美元。銷售額環比成長依然強勁，超過 12%。在我們產品推出的第二年，這些水準的季度成長率是長期需求的有力指標。我們在第二季度交付了超過 79,000 份商業劑量和約 5,000 個 SYFOVRE 樣品。

Demand continued to accelerate with June being our highest demand month since launch through the second quarter. We are particularly pleased to see the continued progress across the many factors driving growth, including new patient demand and a broadening prescriber base.

需求持續加速，六月是我們自第二季推出以來需求最高的月份。我們特別高興地看到推動成長的許多因素持續取得進展，包括新的患者需求和不斷擴大的處方者基礎。

Cedric mentioned some of the competitive dynamics, which I know is on everyone's mind, so let's start there. Our competitor had recent tailwinds driven by factors such as obtaining its new J-Code, and so it is expected that they would see their proportion of new patient share accelerate. We also saw an acceleration when SYFOVRE J-Code went into effect last October.

塞德里克提到了一些競爭動態，我知道每個人都關心這些，所以讓我們從這裡開始。我們的競爭對手最近受到獲得新 J 代碼等因素的推動，因此預計他們的新患者份額比例將會加速。去年 10 月 SYFOVRE J 程式碼生效後，我們也看到了加速發展。

However, we do not believe this is indicative of longer-term market dynamics. We have taken the long view on contracting. As we believe this is a large and growing market, and believe that discounting too aggressively now is unsustainable and will lead to price degradation over time. We are also executing our strategic plan in the field to reinforce SYFOVRE benefit risk profile.

然而，我們認為這並不代表長期市場動態。我們對合約有著長遠的眼光。因為我們相信這是一個龐大且不斷增長的市場，並且認為現在過於激進的折扣是不可持續的，並且隨著時間的推移將導致價格下降。我們也正在現場執行我們的策略計劃，以加強 SYFOVRE 的效益風險狀況。

SYFOVRE remains the number one chosen treatment for GA with approximately 75% of the treated market as defined by the total number of patients treated. We believe SYFOVRE’s position as the market leader will continue to be driven by its differentiated efficacy profile and flexible dosing.

SYFOVRE 仍然是 GA 首選的治療藥物，約佔治療市場的 75%（以治療患者總數計算）。我們相信 SYFOVRE 作為市場領導者的地位將繼續受到其差異化功效和靈活劑量的推動。

Importantly, we are also focused on maintaining market leadership whilst growing the overall GA category. We are still in the beginning stages. Our estimate based on claims data is that about 13% of GA patients who have been diagnosed and are managed by an eyecare professional are currently being treated.

重要的是，我們也致力於保持市場領先地位，同時發展整體通用航空類別。我們仍處於起步階段。我們根據索賠數據估計，約 13% 已被診斷並由眼科護理專業人員管理的 GA 患者目前正在接受治療。

In addition, only a small portion of newly diagnosed and treated patients are referrals, meaning that most patients currently receiving treatment were already being seen by a retina specialist. This suggests that the majority of GA patients have not yet been diagnosed or referred to retina specialists, reinforcing that we have only scratched the surface of the large opportunity for SYFOVRE.

此外，只有一小部分新診斷和治療的患者被轉診，這意味著目前接受治療的大多數患者已經接受了視網膜專家的檢查。這表明大多數 GA 患者尚未被診斷或轉診給視網膜專家，這表明我們僅僅觸及了 SYFOVRE 巨大機會的表面。

As I mentioned on our last earnings call, we are now executing the next phase of our commercial and medical strategy. After the ASRS meeting in 2023, we developed a two-phase strategic plan with a two-year timeline.

正如我在上次財報電話會議上提到的，我們現在正在執行下一階段的商業和醫療策略。在 2023 年 ASRS 會議之後，我們制定了一個為期兩年的兩階段策略計畫。

Phase 1 was focused on being transparent and educating the retina community about everything we were learning at the time around safety. This past quarter we shifted to Phase 2 of the strategy, which is focused on strengthening our leadership in this growing market. More than 2,100 sites of care have ordered SYFOVRE. We are now on our front foot, expanding the number of new physicians using SYFOVRE, deepening our relationships with existing SYFOVRE users, establishing strong payer access and reimbursement and increasing awareness and education for patients.

第一階段的重點是保持透明，並就我​​們當時在安全方面學到的一切向視網膜社區進行教育。上個季度，我們轉向了該策略的第二階段，該階段的重點是加強我們在這個不斷增長的市場中的領導地位。超過 2,100 個護理機構已訂購 SYFOVRE。我們現在處於領先地位，擴大了使用 SYFOVRE 的新醫生數量，加深了與現有 SYFOVRE 用戶的關係，建立了強大的付款人訪問和報銷管道，並提高了患者的意識和教育。

With physicians, we are communicating a clean and simple efficacy message highlighting SYFOVRE increasing effects over time, which is critical given that GA is a chronic disease. We are also sharing the microperimetry data from the Gale extension study. The only data for an approved GA treatment that demonstrates a visual function benefit in a pre-specified endpoint.

我們正在與醫生傳達清晰、簡單的功效訊息，強調 SYFOVRE 的效果會隨著時間的推移而增強，鑑於 GA 是一種慢性疾病，這一點至關重要。我們也分享 Gale 擴展研究的微視野測量數據。經批准的 GA 治療的唯一數據，證明在預先指定的終點中具有視覺功能益處。

This allows for a productive benefit-risk discussion with the every-other-month dosing option having a dramatically positive impact for patients, doctors and payers. We had a successful ASRS meeting a few weeks ago, our first big retina meeting leading with these messages and look forward to the upcoming fall congresses. We are also continuing to broaden our reach to more retina specialists, as well as other referring eyecare providers who see ten of thousands of GA patients. Reaching these physicians and educating them on the referral process are key to developing the GA market. With payers, we have secured unprecedented and broad coverage for patients choosing SYFOVRE.

這樣可以就每隔一個月的給藥方案進行富有成效的利益-風險討論，對病人、醫生和付款人產生顯著的正面影響。幾週前，我們成功召開了 ASRS 會議，這是我們的第一次大型視網膜會議，傳達了這些訊息，並期待即將到來的秋季大會。我們也繼續擴大我們的服務範圍，涵蓋更多的視網膜專家，以及其他為數以萬計的 GA 患者提供轉診的眼科護理提供者。接觸這些醫生並教育他們轉診流程是開發 GA 市場的關鍵。透過付款人，我們為選擇 SYFOVRE 的患者提供了前所未有的廣泛覆蓋。

We are thrilled to share that two large national pharmacy benefit managers have recently made SYFOVRE the only preferred treatment on their commercial formularies. As the preferred product, this means that the new patients with commercial insurance will have full access to SYFOVRE as the first-line treatment and an exception process will have to be undertaken for non-preferred or disadvantaged products.

我們很高興告訴大家，兩家大型國家藥品福利管理公司最近將 SYFOVRE 列為其商業處方中唯一的首選治療方法。作為首選產品，這意味著擁有商業保險的新患者將可以完全使用 SYFOVRE 作為第一線治療，而對於非首選或弱勢產品則必須採取例外程序。

While payers have several considerations in making such decisions, we believe these decisions were driven by SYFOVRE compelling value proposition, highlighting its robust efficacy with increasing effects over time and both monthly and more importantly, every other month dosing.

雖然付款人在做出此類決定時有多種考慮因素，但我們相信這些決定是由SYFOVRE 令人信服的價值主張所驅動的，突出了其強大的功效，隨著時間的推移，以及每月一次，更重要的是每隔一個月一次的劑量，效果不斷增強。

These two PBM decisions are important milestones demonstrating payers strong belief in SYFOVRE clinical and economic value proposition. As ensuring broad coverage and seamless reimbursement is critical for the retina specialists.

這兩項 PBM 決定是重要的里程碑，表明付款人對 SYFOVRE 臨床和經濟價值主張的堅定信念。確保廣泛的覆蓋範圍和無縫報銷對於視網膜專家來說至關重要。

And with patients, we've launched the first phase of our branded DTC campaign in the spring, which is focused on encouraging patients to talk to their physicians about GA treatment with SYFOVRE.

對於患者，我們在春季啟動了品牌 DTC 活動的第一階段，重點是鼓勵患者與醫生討論 SYFOVRE 的 GA 治療。

We're excited to launch Phase 2 of our branded DTC campaign, extending our relationship with the beloved Henry Winkler in the fourth quarter. This is a very large market and we will be methodical in executing this next phase in order to set ourselves up for the long term. We will continue to execute flawlessly and be focused on getting more doctors, patients, and payers to understand the efficacy and the benefits that the leading GA drug can deliver.

我們很高興啟動我們品牌 DTC 活動的第二階段，在第四季度擴大我們與深受喜愛的亨利溫克勒 (Henry Winkler) 的關係。這是一個非常大的市場，我們將有條不紊地執行下一階段，以便為長期發展做好準備。我們將繼續完美地執行，並專注於讓更多的醫生、患者和付款人了解領先的 GA 藥物可以提供的功效和益處。

Now, let me shift to EMPAVELI. In the second quarter, EMPAVELI generated approximately $24.5 million in US net product sales. The positive trends across the key leading indicators for the PNH patient population continue into 2024.

現在，讓我談談 EMPAVELI。第二季度，EMPAVELI 在美國的產品淨銷售額約為 2,450 萬美元。PNH 患者群體的主要領先指標的正面趨勢將持續到 2024 年。

Specifically, compliance rates remain high at 97%, and we continue to have a very strong safety profile. As we previously said, with the availability of an oral treatment for PNH, we are facing a more competitive market and expect sales to be flat at least through the next 6 months to 12 months. We continue to have new patients starting in EMPAVELI treatment, but this has been offset by some patients switching to an oral.

具體而言，合規率仍然高達 97%，並且我們仍然擁有非常強大的安全狀況。正如我們之前所說，隨著 PNH 口服治療的出現，我們面臨著競爭更加激烈的市場，並預計至少在未來 6 個月至 12 個月內銷售額將持平。我們繼續有新患者開始接受 EMPAVELI 治療，但這已被一些患者轉為口服治療所抵消。

Finally, I will echo cedric's enthusiasm regarding the opportunity to potentially expand EMPAVELI into C3G and IC-MPGN. This market is approximately 3 times larger than the PNH market, and there are no available treatments.

最後，我將回應 cedric 對將 EMPAVELI 擴展到 C3G 和 IC-MPGN 的機會的熱情。該市場大約是 PNH 市場的 3 倍，並且沒有可用的治療方法。

If EMPAVELI is approved in these indications, we are confident that we can leverage much of our existing infrastructure to rapidly reach nephrologists and deliver EMPAVELI to the thousands of patients suffering from these diseases.

如果 EMPAVELI 在這些適應症中獲得批准，我們相信我們可以利用我們現有的基礎設施快速接觸腎臟病專家，並將 EMPAVELI 提供給成千上萬患有這些疾病的患者。

With that, I will now turn the call over to Caroline. Caroline.

現在，我將把電話轉給卡羅琳。卡洛琳.

Thanks, Adam, and good morning, everyone. We are looking forward to sharing the valiant data later this month. I'll talk more about this opportunity in a minute. I will first talk about SYFOVRE as our team was recently at the ASRS meeting in Stockholm where we had a significant presence with five oral presentations, including a late breaking abstract on visual function from Gail. We are particularly excited by these visual function data as this was the first time a geographic atrophy treatment had demonstrated a visual function benefit on a pre-specified analysis.

謝謝亞當，大家早安。我們期待在本月晚些時候分享勇敢的數據。我稍後會詳細討論這個機會。我首先要談談 SYFOVRE，因為我們的團隊最近參加了在斯德哥爾摩舉行的 ASRS 會議，我們在會議上進行了五場口頭演講，其中包括來自 Gail 的關於視覺功能的最新摘要。我們對這些視覺功能數據感到特別興奮，因為這是第一次在預先指定的分析中證明地理萎縮治療對視覺功能有好處。

Results showed that with respect to the Microperimetry endpoint, patients treated with Pegcetacoplan monthly or every other month developed fewer new Scotomatous points over 36 months compared to patients from the sham crossover group.

結果顯示，就微視野測量終點而言，與假交叉組的患者相比，每月或每隔一個月接受 Pegcetacoplan 治療的患者在 36 個月內出現的新暗點較少。

Scotomatous points measure the areas of the retina that have lost all light sensitivity and therefore are no longer functioning. These results add to the largest body of evidence for our geographic atrophy treatment and reinforce the unprecedented effects shown by SYFOVRE to both meaningfully slow geographic atrophy lesion growth and, by doing so, preserve visual function.

暗點測量的是視網膜上失去所有光敏感性並因此不再發揮作用的區域。這些結果為我們的地理萎縮治療提供了最有力的證據，並強化了 SYFOVRE 所顯示出的前所未有的效果，既可以有效減緩地理萎縮病變的生長，又可以保留視覺功能。

ASRS is one of the most important retina meetings of the year, and we had the opportunity to engage with many members of the retina community. This was a highly successful meeting for SYFOVRE and we heard repeatedly from doctors about its differentiated benefits. We look forward to continuing to engage with this community at upcoming meetings and to share the ongoing progress of SYFOVRE in patients with geographic atrophy.

ASRS 是今年最重要的視網膜會議之一，我們有機會與視網膜界的許多成員進行交流。對於 SYFOVRE 來說，這是一次非常成功的會議，我們多次聽到醫生講述其獨特的優勢。我們期待在即將召開的會議上繼續與該社區互動，並分享 SYFOVRE 在地理萎縮患者中的持續進展。

Moving to EMPAVELI. Later this month, we expect to share top line results from our Phase 3 VALIANT study of Pegcetacoplan in people living with C3G and IC-MPGN, two rare and debilitating kidney diseases caused by uncontrolled complement activation and breakdown of C3.

搬到恩帕韋利。本月晚些時候，我們預計將分享Pegcetacoplan 在C3G 和IC-MPGN 患者中進行的3 期VALIANT 研究的主要結果，這兩種罕見且令人衰弱的腎臟疾病是由不受控制的補體激活和C3分解引起的。

Patients are usually diagnosed in adolescence and about 50% advanced end stage kidney failure in five years to 10 years. Treatment options are generally a kidney transplant or lifelong dialysis, neither of which are curative.

患者通常在青春期被診斷出來，約 50% 的患者在 5 至 10 年內出現晚期腎衰竭。治療選擇通常是腎臟移植或終身透析，這兩種方法都無法治癒。

In fact, nearly 90% of transplant patients experience disease recurrence, and about half of them end up losing their transplanted organ. The Phase 3 VALIANT study enrolled 124 patients with either C3G or primary IC-MPGN. This is the largest single trial conducted in these populations and the only Phase 3 study to enroll a broad population inclusive of adolescent and adult patients with native and post-transplant forms of disease. The primary endpoint of the VALIANT trial is a Log-transformed ratio of Urine Protein to Creatinine Ratio or UPCR, a key marker of disease progression in all patients at week 26 compared to baseline.

事實上，近90%的移植患者會出現疾病復發，其中約一半最終會失去移植器官。3 期 VALIANT 研究招募了 124 名患有 C3G 或原發性 IC-MPGN 的患者。這是在這些人群中進行的最大的單一試驗，也是唯一一項招募廣泛人群的 3 期研究，其中包括患有天然疾病和移植後疾病的青少年和成年患者。VALIANT 試驗的主要終點是尿蛋白與肌酸酐比率（UPCR）的對數轉換比率，這是所有患者在第 26 週與基線相比疾病進展的關鍵標誌。

We view success in this trial as the achievement of a statistically significant response to the primary endpoint, as well as positive effects in some of the additional secondary endpoints. Physicians have shared that this would be clinically meaningful for these patients.

我們認為這項試驗的成功是對主要終點的統計顯著反應的實現，以及對一些額外次要終點的正面影響。醫生表示，這對這些患者俱有臨床意義。

If VALIANT is positive, we plan to submit the supplemental NDA to the FDA for approval. Following the completion of the VALIANT study, patients were given the option to enroll into the VALIANT long-term extension study. We were highly encouraged to see that a 100% of the patients, who have already completed VALIANT have now enrolled into depth.

如果 VALIANT 呈陽性，我們計劃向 F​​DA 提交補充 NDA 以獲得批准。VALIANT 研究完成後，患者可以選擇參加 VALIANT 長期擴展研究。我們非常高興地看到 100% 完成 VALIANT 的患者現在已入組深度治療。

Beyond the VALIANT study, we are continuing to advance our earlier stage pipeline such as our C3 siRNA, that is currently in Phase 1 development and our beam collaboration. Like Cedric said, we are excited to share more details about our pipeline programs with you at an Investor Day later this year.

除了 VALIANT 研究之外，我們還在繼續推進我們的早期研發管線，例如目前正處於第一階段開發的 C3 siRNA 以及我們的 Beam 合作。正如塞德里克所說，我們很高興在今年稍後的投資者日與您分享有關我們管道計劃的更多細節。

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

我現在將把電話轉給蒂姆，以審查財務狀況。提姆？

Thank you, Caroline. I will now provide an overview of our financials and some comments on our debt refinancing with -- . Additional details are available in the press release that we issued earlier this morning. Total revenue for the second quarter of 2024 was approximately $200 million, including $155 million in SYFOVRE and $24.5 million in EMPAVELI net product revenue. This compares with $95 million in total revenue in the second quarter of 2023.

謝謝你，卡洛琳。我現在將概述我們的財務狀況以及對我們債務再融資的一些評論——。更多詳細資訊請參閱我們今天早上早些時候發布的新聞稿。2024年第二季的總收入約為2億美元，其中SYFOVRE的1.55億美元和EMPAVELI的產品淨收入為2,450萬美元。相比之下，2023 年第二季的總收入為 9,500 萬美元。

Turning to the rest of the P&L. For the second quarter, cost of sales was $23 million, R&D expenses were $78 million, SG&A expenses were $128 million, and we reported a net loss of $38 million. As I previously stated, we are realizing efficiencies this year related to our restructuring in 2023 and continue to expect our total operating expenses in 2024, inclusive of R&D and SG&A expenses to be less than our total expenses in 2023.

轉向損益表的其餘部分。第二季度，銷售成本為 2,300 萬美元，研發費用為 7,800 萬美元，SG&A 費用為 1.28 億美元，淨虧損為 3,800 萬美元。正如我之前所說，我們今年正在實現與 2023 年重組相關的效率，並繼續預計 2024 年的總營運費用（包括研發和銷售、一般行政費用）將低於 2023 年的總費用。

This year, we've been focused on strengthening our balance sheet. These efforts ultimately resulted in a strategic non-dilutive refinancing collaboration with Sixth Street that we announced in May. The deal allowed us to prepay our SFJ debt at a significant discount and to free up substantial cash flow.

今年，我們一直致力於加強我們的資產負債表。這些努力最終促成了我們在 5 月宣布的與第六街的策略性非稀釋性再融資合作。該交易使我們能夠以大幅折扣提前償還 SFJ 債務，並釋放大量現金流。

A quick look at the terms revealed how favorable this deal was. First, this debt facility provides us with up to $475 million of which $375 million became available immediately upon closing. We can access the remaining $100 million at our option over time.

快速瀏覽一下條款就可以看出這筆交易是多麼有利。首先，這項債務融資為我們提供了高達 4.75 億美元的資金，其中 3.75 億美元在交易結束後立即可用。隨著時間的推移，我們可以選擇使用剩餘的 1 億美元。

Importantly, this deal was debt neutral to Apellis. We replaced $366 million in payments due to SFJ over the next few years with $375 million from Sixth Street. The principal repayment is pushed out to May, 2030 when SYFOVRE revenues are expected to be closer to peak.

重要的是，這筆交易對 Apellis 來說是債務中立的。我們用來自第六街的 3.75 億美元取代了未來幾年應付 SFJ 的 3.66 億美元。本金償還被推遲到 2030 年 5 月，屆時 SYFOVRE 收入預計將接近高峰。

Our payments are interest only until then. This deal also substantially improves our liquidity and provides flexibility to access at least $200 million in incremental non-dilutive capital as we continue to invest in profitable growth. And it includes a record-low credit spread. The overall terms were some of the best in biotech seen in recent history.

在此之前我們的付款僅是利息。這項交易還大大提高了我們的流動性，並為我們繼續投資於獲利成長提供了獲得至少 2 億美元增量非稀釋資本的靈活性。其中包括創紀錄的低信用利差。整體而言，這些條款是近代史上生物技術領域中最好的條款之一。

In aggregate, since the beginning of the year, we have unlocked over $475 million in non-dilutive capital, including $100 million from the capped call unwind announced in the first quarter. Plus, we have the flexibility to bring in $100 million within the accounts receivable line, which can be increased to $200 million upon the achievement of certain milestones and $100 million more from Sixth Street. So, a total of $775 million in non-dilutive financial flexibility.

總的來說，自今年年初以來，我們已釋放了超過 4.75 億美元的非稀釋資本，其中包括第一季宣布的上限看漲期權解除中的 1 億美元。此外，我們還可以靈活地在應收帳款額度內引入 1 億美元，在實現某些里程碑後可將其增加至 2 億美元，並從第六街再增加 1 億美元。因此，非稀釋性財務彈性總計為 7.75 億美元。

This combined with the $360 million in cash and cash equivalents that we have at the end of June 30, 2024 puts us in a strong financial position where we are on a path to becoming cashflow positive and no longer having to rely on the capital markets to fund the business.

再加上截至2024 年6 月30 日我們擁有的3.6 億美元現金和現金等價物，使我們處於強勁的財務狀況，我們正走在現金流正向的道路上，而不必再依賴​​資本市場來實現盈利。

Importantly, our ability to begin generating cash is possible in both the EU and non-EU scenarios. While we believe the opportunity in Europe is significant, the ramp to peak sales is much longer. And so, the main source of profitability in the near term remains growth in the US.

重要的是，我們在歐盟和非歐盟的情況下都有可能開始產生現金。雖然我們相信歐洲的機會很大，但達到銷售高峰的時間要長得多。因此，短期獲利的主要來源仍然是美國的成長。

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

我現在將把電話轉回給塞德里克進行結束語。塞德里克？

Thanks, Tim. We've had a very strong first half of the year. With two successful commercial products, a pipeline of innovative programs and development and a strong financial position to support the business and I'm more confident than ever in our ability to continue creating significant value for our patients and our shareholders.

謝謝，蒂姆。今年上半年我們表現非常強勁。憑藉兩款成功的商業產品、一系列創新計劃和開發以及支持業務的強大財務狀況，我比以往任何時候都更有信心我們有能力繼續為我們的患者和股東創造巨大價值。

And we will now open the call for questions.

我們現在開始提問。

Thank you. (Operator Instructions)

謝謝。（操作員說明）

Jon Miller, Evercore.

喬恩‧米勒，《Evercore》。

Thanks so much for taking the questions. I would love to start with, I'll start with this. Do you expect the share of new starts currently around that 50% mark to grow again post a successful ASRS and then I guess the corollary to that is, your guidance to cashflow positivity, you just mentioned doesn't assume anything more than US GA launches, but does it assume more than the existing share of new starts in the US.

非常感謝您提出問題。我很想從這裡開始，我將從這個開始。您是否預計在成功的ASRS 後，目前新啟動的份額將在50% 左右再次增長，然後我猜其推論是，您剛才提到的對現金流積極性的指導並沒有假設除美國通用汽車啟動之外的任何內容，但它是否假設超過美國現有的新開工份額。

Thank you so much and great to hear you. So, that is of course the most important question, right. I mean, is the new starts in the second quarter as we have discussed, there were tailwinds for SYFOVRE, but as we now move forward, what really stands out and what is very encouraging to see is a very large market and the fact that SYFOVRE is leading on efficacy, flexible dosing, and economic value. So, as we move forward now, we plan to recapture the lead on those first injections and take advantage of this very large market with an important unmet need.

非常感謝您，很高興聽到您的聲音。所以，這當然是最重要的問題，對吧。我的意思是，正如我們所討論的那樣，第二季度的新開局對SYFOVRE 來說是有利的，但隨著我們現在向前邁進，真正突出且非常令人鼓舞的是一個非常大的市場以及SYFOVRE 的事實在功效、靈活劑量和經濟價值方面處於領先地位。因此，隨著我們現在的前進，我們計劃重新奪回第一輪注射的領先地位，並利用這個有著重要未滿足需求的龐大市場。

Adam, do you want to add?

亞當，你想補充嗎？

We're in Phase 2 and we're already encouraged by the growth and the demand we're seeing into July. We're on the front foot. We're talking about efficacy. We're talking about every other month dosing. These are huge differentiating factors, spike drop. We can see the future and we can see that we will continue to be the number one GA drug in this market. Tim, do you have any suggestions.

我們正處於第二階段，我們已經對 7 月看到的成長和需求感到鼓舞。我們處於領先地位。我們談的是功效。我們正在討論每隔一個月給藥一次。這些都是巨大的差異化因素，峰值下降。我們可以看到未來，我們可以看到我們將繼續成為這個市場上排名第一的 GA 藥物。提姆，你有什麼建議嗎？

So, in terms of cash flow, our revenue was $199.7 and our cash OpEx if you take out stock-based comp and depreciation is just under that. So that was $199 a little bit less than that. So really on a total OpEx basis, on a cash basis, we are net neutral.

因此，就現金流而言，我們的收入為 199.7 美元，如果扣除基於股票的補償和折舊，我們的現金營運支出就略低於此。所以 199 美元比這個少了一點。因此，實際上，在總營運支出的基礎上，在現金的基礎上，我們是淨中性的。

So the differences right now are working capital and of course interest expense. So, it really doesn't take much in terms of growth for us to become cash flow positive. We're not guiding to when that will happen. But given the size of the market and the growth in this market, I don't think that's something we're worried about.

所以現在的差別是營運資金，當然還有利息支出。因此，我們實際上不需要太多的成長就能實現正現金流。我們不會指導這種情況何時發生。但考慮到市場的規模和市場的成長，我認為這不是我們擔心的事情。

And I guess my follow-up would be your language on EU approval seems more positive now than it has in the past. And you mentioned that you're well positioned heading into this appeal. And I think that's a little bit more positive than the previous messaging we had occurred where we're all assumption. All of our assumption was that this was not the base case, but how do you feel now versus how you thought last time you had into an appeal? And do you really feel like the likelihood of an approval without further trials or without further reach a resubmission is much higher.

我想我的後續行動是你關於歐盟批准的語言現在看起來比過去更積極。您提到您在上訴中處於有利地位。我認為這比之前我們所假設的消息要積極一些。我們所有的假設都是這不是基本情況，但是與上次上訴時的想法相比，您現在的感覺如何？您是否真的覺得無需進一步試驗或無需進一步重新提交即可獲得批准的可能性要高得多？

Thank you. So the expectation should remain the same. But this of course, one nice takeaway from the fact that this procedure was reset was the ability for us to introduce new data and that includes the prespecified endpoints of function just of course, as something really important and encouraging and really speaks to the appeal of this drug to patients. So again, in terms of expectations, that has not changed, the process has gone according to plan. We've been disciplined and we look forward to the fall, it's to share with the results.

謝謝。所以期望應該保持不變。但這當然，從這個程序被重置的事實中得到的一個很好的收穫是我們能夠引入新數據，當然包括預先指定的功能終點，因為這是非常重要和令人鼓舞的事情，並且真正說明了這種藥給患者。因此，就預期而言，這一點沒有改變，整個過程都按計劃進行。我們一直遵守紀律，我們期待秋天的到來，與大家分享成果。

Anupam Rama, JPM.

阿努帕姆·拉瑪，JPM。

Thanks so much for taking the question. You guys noted that for SYFOVRE, June was your best month since launch. Maybe you could give us a little more color on what you were seeing on a month-by-month basis in the quarter. Was the -- sort of J-Code impact more like first half of the quarter dynamic and then you saw reacceleration of SYFOVRE regrowth? Or how do we think about like what the dynamics were within the quarter? Thanks so much.

非常感謝您提出問題。你們注意到，對於 SYFOVRE 來說，六月是自推出以來表現最好的一個月。也許您可以給我們更多關於您在本季逐月看到的情況的資訊。J-Code 的影響是否更像是季度前半段的動態，然後您看到 SYFOVRE 再生加速？或者我們如何看待本季的動態？非常感謝。

Thanks so much. I will hand it over to Adam, but I think again what stands out here and what we're super excited about is how large this market is, the fact that it's growing, the fact that SYFOVRE does well in a duopoly that, we'll be here for a long time and us having a drug that is meaningfully differentiated on efficacy and dosing flexibility that is really what we are focused on.

非常感謝。我會把它交給 Adam，但我再次認為這裡最突出的、我們超級興奮的是這個市場有多大、它正在增長的事實、SYFOVRE 在雙寡頭壟斷中做得很好的事實，我們'我們將在這裡待很長一段時間，我們擁有一種在功效和劑量靈活性方面具有顯著差異化的藥物，這才是我們真正關注的重點。

But Adam, you may want to add something.

但是亞當，你可能想補充一些東西。

June was the highest month of the quarter and also the highest month launch today. Across multiple metrics, we saw that Q2 was a very successful quarter for us across the multiple months, right. we continue to grow accounts now can 2,100 sites of care, we saw double-digit growth for the quarter. We're fully into Phase 2 of our plan.

六月是本季最高的月份，也是今天推出的最高月份。從多個指標來看，我們發現第二季度對我們來說是一個非常成功的季度，對吧。我們繼續成長帳戶，現在可以照顧 2,100 個站點，我們看到本季度實現了兩位數的成長。我們已全面進入計劃的第二階段。

And I think some of the initial steps of that happening in June is what we can witness there, right? Talking about efficacy, talking about flexible dose and I think that's what we are really pushing hard as we now move to the next quarter.

我認為我們可以在那裡見證六月發生的一些初步步驟，對嗎？談論功效，談論靈活的劑量，我認為這就是我們在進入下一個季度時真正努力推動的事情。

Salveen Jaswal Richter, Goldman Sachs.

薩爾文·賈斯瓦爾·里希特，高盛。

So, on the competitive dynamics, what are the factors which are driving the competitive and physician dynamics in the GA market following the permanent J-Code for SYFOVRE? And could you speak to the market share that you're seeing at this point and how you expect that to evolve over the near term?

那麼，就競爭動態而言，在 SYFOVRE 永久 J 代碼之後，推動 GA 市場競爭和醫生動態的因素有哪些？您能否談談您目前所看到的市場份額以及您預計該市場份額在短期內將如何發展？

So we are the market leader. We plan on continuing to be the market leader and that confidence is based on stability around the safety, which was really important and where SRS was a real turning point for us, those that were there, it was a quiet meeting on that front and the discussion very much shifted towards the efficacy profile and there the majority of doctors clearly see the differentiation of SYFOVRE versus the competition.

所以我們是市場的領導者。我們計劃繼續成為市場領導者，這種信心是建立在安全穩定性的基礎上的，這非常重要，SRS 對我們和那些在場的人來說是一個真正的轉折點，這是關於這方面的一次安靜會議，討論很大程度上轉向了療效概況，大多數醫生清楚地看到 SYFOVRE 與競爭對手的區別。

So, as we now move forward, the focal point will more and more become efficacy, the differentiation, the long-term data, the mass amount of data that we have with SYFOVRE, and then the real and important benefit of every other month dosing. So, the convenience that that offers to patients. Also, the fact that health the number of intravitreal injections is twice as safe as monthly injections. All of these things are going to come more into focus.

因此，隨著我們現在的前進，焦點將越來越成為功效、差異化、長期數據、我們透過 SYFOVRE 獲得的大量數據，以及每隔一個月給藥的真正而重要的好處。因此，這為患者提供了便利。此外，事實上，玻璃體內注射的健康次數是每月注射的安全性的兩倍。所有這些事情都將變得更加受到關注。

Adam, if you want to add?

亞當，你想補充嗎？

So obviously, if you go back to our J-Code, we also noticed tailwinds when we had our J-Code, it unlocked certain new accounts. So, the competitor had some tailwinds. And even with those tailwinds we maintained approximately 50% of new starts and market leadership, 75% of the total market. That is down at Cedric said to a real successful execution of Phase 2 of our strategic plan, plus some positive comments moving forward from ASRS.

很明顯，如果你回到我們的 J 代碼，我們也注意到當我們擁有 J 代碼時順風順水，它解鎖了某些新帳戶。因此，競爭對手有一些順風車。即使有這些有利因素，我們仍保持約 50% 的新開工率和市場領導地位，佔整個市場的 75%。Cedric 表示，這表明我們戰略計劃第二階段的真正成功執行，加上 ASRS 的一些積極評論。

Now, you also asked about market share. So, we track market share based on vials going into physicians and then being injected into patients. And so we think that's the most robust way of measuring market share and we had a 75% market share. Now as this market grows, we will continue to push incredibly hard on our efficacy message, our dosing convenience, and the economic value. And we think that will maintain our leadership.

現在，您也詢問了市場佔有率。因此，我們根據進入醫生然後注射到患者體內的小瓶子來​​追蹤市場份額。因此，我們認為這是衡量市場份額的最可靠方法，我們擁有 75% 的市場份額。現在，隨著這個市場的成長，我們將繼續大力宣傳我們的功效資訊、劑量便利性和經濟價值。我們認為這將保持我們的領導地位。

Yigal Dov Nochomovitz, Citigroup.

Yigal Dov Nochomovitz，花旗集團。

Shifting over to C3G and IC-MPGN. -- I just wanted to get your thoughts on how you expect the position type for the Copeland in this market, assuming VALIANT is positive? And what do you think you need to show on proteinuria as well as some of the other secondary endpoints that Caroline mentioned to be competitive with the emerging oral options?

轉向 C3G 和 IC-MPGN。 -- 我只是想了解您對 Copeland 在這個市場中的頭寸類型的期望，假設 VALIANT 是積極的？您認為您需要在蛋白尿以及卡羅琳提到的其他一些次要終點方面展示什麼，以與新興的口服選擇競爭？

Sorry, Yigal, we had a hard time hearing it here. Tim, who -- . So, look, we are very excited about the opportunity in C3G and IC-MPGN. This is something that has been a little bit below the radar screen of most, but a really large and important opportunity for us.

抱歉，Yigal，我們在這裡很難聽到它。提姆，誰——。所以，我們對 C3G 和 IC-MPGN 領域的機會感到非常興奮。這是大多數人沒有註意到的事情，但對我們來說是一個非常大且重要的機會。

We have seen the results from the noble study, where we have the histopath data, which is really best in class, ever seen within this disease. We also have already, while this drug is not on the market, yet seen the excitement around science for this drug. And we have seen in the NOBLE study, approximately 50% reductions in the protein area.

我們已經看到了這項崇高研究的結果，其中我們有組織病理學數據，這在這種疾病中確實是同類中最好的。雖然這種藥物尚未上市，但我們也已經看到了這種藥物的科學興奮。我們在 NOBLE 研究中看到，蛋白質面積減少了約 50%。

So that is, of course, the goal for us is to meet statistical significance on the primary endpoint and then to really pay attention to the transplanted population. So, I hope that answers your question.

當然，我們的目標是在主要終點上達到統計顯著性，然後真正專注於移植族群。所以，我希望這能回答你的問題。

No. That's helpful. And then, just another question. From people's design and VALIANT, we are combining C3G and IC-MPGN into one study. Obviously, the competitor is doing separate studies for both indications. Do you see that as being a significant difference in terms of how physicians will interpret and implement the data when both those are approved?

不。這很有幫助。然後，還有一個問題。從人們的設計和VALIANT出發，我們正在將C3G和IC-MPGN結合到一項研究中。顯然，競爭對手正在對這兩種適應症進行單獨的研究。您認為這兩種方法獲得批准後，醫生如何解釋和實施數據方面有顯著差異嗎？

That will depend on the data, right? So, I think you bring up a very important point, which is that the way in which the study reads out should be viewed in the context, of course, what we have seen with VALIANT. We decided to include in one study both C3G and IC-MPGN, with the hope that the data would be good enough for both to find their way into our label. So, we're going to see if that's the case or not. And we're going to see how the data stacks up against what has already been disclosed by Novartis in the past months.

這將取決於數據，對嗎？所以，我認為你提出了一個非常重要的觀點，那就是研究的解讀方式應該在脈絡中看待，當然，我們在 VALIANT 中看到了這一點。我們決定將 C3G 和 IC-MPGN 納入一項研究中，希望數據足夠好，讓兩者都能進入我們的標籤。因此，我們將看看情況是否如此。我們將看看這些數據如何與諾華過去幾個月所揭露的數據進行比較。

Steve Seedhouse, Raymond James.

史蒂夫席德豪斯，雷蒙德詹姆斯。

First question, I just, regarding a new line item on the balance sheet for long-term inventory, a $23 million entry. Has there been any change to the expected sales trajectory in the next 12 months versus prior? Are you anticipating that entry will be gone in subsequent quarters or is it going to grow? And then also what is the shelf life of the raw materials, I guess, that comprise that entry?

第一個問題，我只是關於資產負債表上長期庫存的一個新項目，即 2300 萬美元的條目。與之前相比，未來 12 個月的預期銷售軌跡是否有任何變化？您預計該條目會在接下來的幾季消失還是會增加？我想，構成該條目的原料的保質期是多少？

So that entry was put in place because we have to do our ordering for our inventory long and advanced. And we had planned for the potential success of ALS. There's also a couple of other factors, which include the delay in the EU for SYFOVRE and also our expected ordering from -- .

因此，該條目已就位，因為我們必須對庫存進行長期且提前的訂購。我們已經為 ALS 的潛在成功做好了計劃。還有其他一些因素，其中包括 SYFOVRE 在歐盟的延遲以及我們預計的訂單——。

So, we had to plan for all that well in advance. And so much of that, in fact, most of it has to do with -- . So, we don't know exactly how long that line item will last there, but most of that inventory has a shelf life of three years or more. So, we just put that in place because of the dynamics we talked about, but it's primarily in the -- .

因此，我們必須提前做好計劃。事實上，其中大部分都與——。因此，我們並不確切知道該訂單項目將在那裡持續多久，但大多數庫存的保質期為三年或更長。因此，我們之所以將其落實到位，是因為我們談到了動態，但它主要是在——。

Okay, good to know. And then just on the dynamic of patients, maybe switching between Izervay and SYFOVRE, do you have good visibility into both directions of switching there? And has it been, if so, has it been sort of a net positive, net negative, or net neutral in terms of unique patients on either drug? Thanks.

好的，很高興知道。然後就患者的動態而言，也許在 Izervay 和 SYFOVRE 之間切換，您對那裡切換的兩個方向有很好的了解嗎？如果是的話，就使用這兩種藥物的獨特患者而言，它是淨陽性、淨陰性還是淨中性？謝謝。

Hi, Steve, it's Adam. So yes, we have some visibility to that now. Obviously, with all analysis that we can do. It's only a subset of the total market. So obviously, last year, we did see some switching from SYFOVRE to Izervay, we saw one or two accounts switch the majority of the patients. And what we have seen moving forward is we've actually seen some switching from Izervay come back to SYFOVRE. And our assumption there is that's based on the efficacy and the flexible dosing of this drug.

嗨，史蒂夫，我是亞當。所以，是的，我們現在對此有了一些了解。顯然，透過我們所能做的所有分析。它只是整個市場的一個子集。顯然，去年我們確實看到一些患者從 SYFOVRE 切換到 Izervay，我們看到一兩個帳戶切換了大多數患者。我們所看到的進展是，我們實際上已經看到一些人從 Izervay 回到了 SYFOVRE。我們的假設是基於該藥物的功效和靈活劑量。

Switching tends to be a very small piece of the market, and it goes both ways based on our data set. As we look forward into Q3 and beyond, right, we're really encouraged by all of the metrics we're seeing about strong demand across multiple metrics. That includes switching as a small piece of it. That includes new starts and our plan to execute everything to push new starts. It includes more physicians writing SYFOVRE for the first time and increasing the number of accounts that are using SYFOVRE.

轉換往往只佔市場的一小部分，根據我們的數據集，它是雙向的。當我們展望第三季及以後時，我們看到的所有指標都顯示出跨多個指標的強勁需求，這讓我們感到非常鼓舞。這包括將其作為其中的一小部分進行切換。這包括新的開始以及我們執行一切措施以推動新的開始的計劃。其中包括更多的醫生首次編寫 SYFOVRE，並增加了使用 SYFOVRE 的帳戶數量。

We're really, really positive on what we're seeing so far, and we think a lot of that's down to the strong efficacy, the leading efficacy, flexible dose and economic value. Hopefully, it balances your question.

我們對迄今為止所看到的情況非常非常樂觀，我們認為這很大程度上歸功於其強大的功效、領先的功效、靈活的劑量和經濟價值。希望它能平衡你的問題。

Colleen Margaret Kusy, Baird.

科琳·瑪格麗特·庫西，貝爾德。

Good morning and thanks for taking our questions. Can you provide any thoughts on when you might provide revenue guidance for SYFOVRE?

早安，感謝您提出我們的問題。您能否對何時為 SYFOVRE 提供收入指導有何想法？

Thank you. And so obviously, we're not providing it for the remainder of this year. That's something we'll reconsider for next year. But we're not guiding on the guide yet.

謝謝。顯然，我們不會在今年剩餘時間內提供它。這是我們明年將重新考慮的事情。但我們還沒有對指南進行指導。

Thank you. And then for the EU review. I think you said the repertoires have been selected. Can you can you provide any commentary on the background of the new repertoires ? And if either of them or a dissenting voter from the most recent review.

謝謝。然後接受歐盟審查。我想你說的是劇目已經選定了。您能評論一下新劇目的背景嗎？如果他們中的任何一個或最近一次審查中持反對意見的選民。

Thank you so much, Colleen. So we don't provide details on that. As mentioned, we consider the odds of success to have remained stable. The process to have gone very much in line with what we had expected. And hopefully in the fourth quarter, we'll be able to come back with positive news.

非常感謝你，科琳。所以我們不提供這方面的詳細資訊。如前所述，我們認為成功的幾率保持穩定。這個過程非常符合我們的預期。希望在第四季度，我們能夠帶來正面的消息。

Philip M. Nadeau, TD Cowen.

菲利普‧M‧納多 (Philip M. Nadeau)，TD‧考恩 (TD Cowen)。

(Thanks for taking our questions. On the competitive environment. First, in the prepared remarks in the economy, a couple of other protection from a competitive standpoint and a little bit more about policies from hedge accounting and second, the dynamics of competition. What are you seeing that position center level overall since becoming a survey versus that from a risk positions position using both centers certainly versus the other? Or are they both in the Pacific region because of the outages by the patient about that.) (Technical Difficulty)

（感謝您提出我們的問題。關於競爭環境。首先，在經濟方面準備好的發言中，從競爭角度來看的其他一些保護措施，以及更多關於對沖會計政策的信息，其次是競爭的動態。什麼？ 自從成為調查以來，您是否看到該職位中心的總體水平與使用兩個中心的風險職位的水平相比，或者它們都在太平洋地區，因為患者對此造成了中斷。困難）

Hey, Phil, I don't know, if it's Apellis or yours, but we have a very hard time hearing your question.

嘿，菲爾，我不知道是阿佩利斯的還是你的，但我們很難聽到你的問題。

Yes. So first on discounting what are you seeing in the marketplace on discounting and what is Apellis is uncertainty and discounting? (Technical difficulty)

是的。那麼首先關於折扣，您在市場上看到的折扣是什麼？（技術難度）

And then second, on competition, can you talk about the -- on the physician center level or centers choosing one or the other? Or are they going patient by patient using SYFOVRE versus separate? (Technical difficulty)

其次，關於競爭，您能談談在醫師中心層級或中心選擇其中之一嗎？或者他們是逐一使用 SYFOVRE 還是單獨使用？（技術難度）

Thank you so much. Adam, do you want to take that?

太感謝了。亞當，你想接受這個嗎？

Thanks for repeating the question. So, contracting's obviously a standard process in this market and we are taking a really strategic and thoughtful view on how we contract in this market. This is a large and growing market and we've only just scratched the surface of moving patients into the market.

感謝您重複這個問題。因此，簽約顯然是這個市場的標準流程，我們對如何在這個市場簽約採取了真正的策略性和深思熟慮的觀點。這是一個巨大且不斷增長的市場，我們在將患者轉移到市場方面才剛剛觸及表面。

So, if you look forward to how big this market could possibly be, we want to maintain as much value as is possible. So, we've been incredibly thoughtful on contracting.

因此，如果您期待這個市場可能有多大，我們希望盡可能保持價值。因此，我們在簽約方面考慮得非常周到。

Then to your second part of your question so at an account level, we have seen that there are many SYFOVRE advocates and fans and these physicians are choosing SYFOVRE for its leading efficacy, flexible dosing. It is now well documented safety profile and the robust real-world evidence and that comes consistently when we interact with physicians at conferences and various other interactions too.

然後到你問題的第二部分，在帳戶層面，我們看到有許多 SYFOVRE 的擁護者和粉絲，這些醫生選擇 SYFOVRE 是因為其領先的功效、靈活的劑量。現在，它已得到充分記錄的安全性概況和可靠的現實世界證據，並且當我們在會議和各種其他互動中與醫生互動時，這些證據都是一致的。

Now, no surprise, there are always some competitor physicians also, who tend to be choosing the competitor for its safety profile. One thing we have noticed, and I don’t know if Caroline wants to comment afterwards is, a lot of physicians will have a discussion about SYFOVRE, for example, with their patient and explain the efficacy profile and the flexible medicine. And some physicians will have the same conversation on eyes. So, the patient voice is also important in this discussion, and we truly believe that efficacy will drive patients to want to choose SYFOVRE.

現在，毫不奇怪，總是有一些競爭對手的醫生，他們往往會因為其安全性而選擇競爭對手。我們注意到的一件事是，許多醫生會與他們的患者討論 SYFOVRE，並解釋療效概況和靈活的藥物，我不知道 Caroline 是否願意事後發表評論。有些醫生也會對眼睛進行同樣的討論。因此，患者的聲音在本次討論中也很重要，我們堅信療效將促使患者選擇 SYFOVRE。

Caroline, anything you want to add?

卡洛琳，你還有什麼要補充的嗎？

I think, when it comes to physician using SYFOVRE, just had an ad board yesterday and speaking with my colleagues at ASRS, they're very driven to have less than monthly dosing, which is consistent with the high efficacy. And they're really also driven by our data that goes into the third year of use that patients have completed the Gale study. Some patients with over five years of continuous use of SYFOVRE. So, to them, the most important thing is to give the maximum efficacy with the least burden for patients.

我認為，當談到使用 SYFOVRE 的醫生時，昨天剛剛看到了一個廣告板，並與 ASRS 的同事交談，他們非常渴望少於每月的劑量，這與高功效是一致的。他們實際上也是由我們的數據驅動的，這些數據進入患者完成 Gale 研究的第三年。有些患者連續使用SYFOVRE超過五年。所以，對他們來說，最重要的是以最小的負擔給患者帶來最大的療效。

Akash Tewari, Jefferies.

阿卡什·特瓦里，杰弗里斯。

Hey, this is Ivy on for Akash. Thanks so much for taking our question. So you've alluded to a safety update second half of this year. Just wanted to get a sense of what that could entail also given eithervae has half amount of PEG in a shorter half-life compared to SYFOVRE? Are you working with ASRS other doctors to run studies looking at dose titration or spaced out dosing regimens for SYFOVRE? And when can we get an update on that?

嘿，這是阿卡什的艾薇。非常感謝您提出我們的問題。所以你提到了今年下半年的安全更新。只是想了解一下，考慮到與 SYFOVRE 相比，Evervae 的 PEG 含量只有一半，半衰期更短，這可能意味著什麼？您是否正在與 ASRS 的其他醫生合作進行有關 SYFOVRE 劑量滴定或間隔給藥方案的研究？我們什麼時候可以得到最新消息？

Thank you so much for that question. So first of all, the safety is now very clear and well established. So then, what was really important for us was the SRS that the ASRS Risk Committee agreed with us, that is on the rarity of these events, one in 4,000 on the first injection and the fact that this is primarily a first injection phenomenon, right? So those are important facts. And of course then you place it in the broader context of the safety where SYFOVRE stacks up very well against Izervay specifically, also because of that every other month of dosing that is available.

非常感謝你提出這個問題。首先，安全性現在非常明確且已確立。那麼，對我們來說真正重要的是 ASRS 風險委員會與我們達成一致的 SRS，即這些事件的罕見性，第一次注射時為 4,000 分之一，而且這主要是第一次注射現象，對吧？所以這些都是重要的事實。當然，然後你將它放在更廣泛的安全背景下，其中 SYFOVRE 特別與 Izervay 相比非常好，也是因為每隔一個月就可以給藥。

So based on an enormous denominator of 330,000 injections. We know very well. But the safety profile is I don't think there's going to be much more discussion around that. What we will talk a lot about now is what the efficacy really looks like. And I think that is where the discussion is going to go.

這是基於 330,000 次注射的巨大分母。我們非常清楚。但安全性是我認為不會有更多的討論。我們現在要討論的就是它的功效到底是什麼樣的。我認為這就是討論的方向。

What was really gratifying to see coming out of ASRS is that everything is becoming more quiet and more reasoned within this field. So only 13% of patients with GA right now have been treated. These patients are desperate for treatment. They are going blind, understanding the safety profile and the efficacy that they get in return is really important and is going to drive the growth of this market for many years to come. So that is something that really stood out.

ASRS真正令人欣慰的是，這個領域的一切都變得更加安靜、更加理性。因此，目前只有 13% 的 GA 患者得到了治療。這些患者迫切需要治療。他們變得盲目，了解安全性和他們獲得的回報的功效非常重要，並將在未來許多年推動這個市場的成長。所以這是真正突出的事情。

In terms of mitigations, for something as rare as this event, it is a question, what can you do? What should you do? It's of course, when it happened, it's not good, but, intravitreal injections carry a risk. Every time you do an intravitreal injection, there's a chance of one in 3,000 to 5,000 of getting infection and of endophthalmitis as well. That is normal with any type of drug. So, this is really something that we're looking forward to. I don't know, if Caroline wants to add something..

就緩解措施而言，對於像這次事件這樣罕見的事情，問題是，你能做什麼？你應該做什麼？當然，當這種情況發生時，情況並不好，但是，玻璃體內注射是有風險的。每次進行玻璃體內注射時，有三千到五千分之一的機會受到感染並引發眼內炎。對於任何類型的藥物來說，這都是正常的。所以，這確實是我們非常期待的事情。我不知道卡羅琳是否想補充一些東西..

I think the retina community has really appreciated our transparency with this and our partnership. I mean, we are driven by science and we're driven by what's best for patient care. And that is the continual feedback.

我認為視網膜界非常讚賞我們在這方面的透明度以及我們的合作關係。我的意思是，我們以科學為動力，以最有利於病人照護的方式為動力。這就是持續的回饋。

And I will tell you that the community would have no problem giving different sort of feedback if that was indicated. So, they're really pleased with this and they're really excited to continue to work with us and develop more data for our patients to give them the best care.

我會告訴你，如果有這樣的指示，社群將毫無問題地提供不同類型的回饋。因此，他們對此感到非常滿意，並且很高興繼續與我們合作，為我們的患者開發更多數據，為他們提供最好的護理。

We're really feeling that momentum this quarter. I mean, it's really, I think ASRS was a real training.

本季我們確實感受到了這種勢頭。我的意思是，我認為 ASRS 是一次真正的培訓。

Eliana Rachel Merle, UBS.

艾利安娜·雷切爾·梅爾 (Eliana Rachel Merle)，瑞銀集團。

Just a quick one on SYFOVRE and then a question on VALIANT. Sorry if I missed this before, but can you confirm, if volumes were up in July versus June for SYFOVRE? And then for VALIANT, just how are you thinking about what's clinically meaningful in the pre-versus post-transplant setting? And then any difference in efficacy expected between these two settings and just commercially how you're thinking about the relative size of the population opportunity for pegcetacoplan in the pre versus post-transplant patients? Thanks.

先簡單介紹一下 SYFOVRE，然後再問一個關於 VALIANT 的問題。抱歉，如果我之前錯過了這一點，但是您能否確認 SYFOVRE 7 月銷售與 6 月相比是否有所增加？那麼對於 VALIANT，您如何看待移植前和移植後的臨床意義？然後，這兩種設定之間預期的療效有什麼差異，以及從商業角度來看，您如何考慮移植前和移植後患者中 pegcetacoplan 的人群機會的相對大小？謝謝。

Thank you so much. Adam, do you want to take this first?

太感謝了。亞當，你想先拿這個嗎？

Sure. Yes, so we're really thrilled with the strong growth because it's continuing into July and we expect it to continue for the rest of the quarter and onwards. We're seeing it across multiple metrics and I think it's down a lot to flawless execution of Phase 2 of our plan. We are now on the front foot and we're pushing hard. So, we're thrilled with what we're seeing into July. We expect that to continue. We're going to work hard to make sure.

當然。是的，我們對強勁的成長感到非常興奮，因為這種成長一直持續到 7 月份，我們預計這種成長將持續到本季度剩餘時間及以後。我們從多個指標中看到了這一點，我認為這很大程度上歸功於我們計劃第二階段的完美執行。我們現在處於領先地位，並且正在努力推進。因此，我們對 7 月所看到的情況感到非常興奮。我們預計這種情況會持續下去。我們將努力確保。

And then as it relates to VALIANT, so pre versus post-transplant. So, as you may recall, Eli, for us, the post-transplant segment is a very intriguing one because it's easy to take biopsies and to track on histopathology what your drug does in that population.

然後，因為它與 VALIANT 相關，所以移植前與移植後。所以，Eli，您可能還記得，對我們來說，移植後階段是一個非常有趣的階段，因為很容易進行活檢並透過組織病理學追蹤您的藥物在該人群中的作用。

It is also a population that was kind of deprioritized by our competitors and it's one that we happily embrace because what is best for a transplanted kidney is best for kidneys with this disease, period. So, this is really something that has many advantages for us to focus on.

這也是一個被我們的競爭對手忽視的人群，我們很高興地擁抱這一人群，因為最適合移植腎臟的也最適合患有這種疾病的腎臟。所以，這確實有很多優點值得我們注意。

But on the other hand, should our data be really good in VALIANT, there is a real opportunity to differentiate from SYFOVRE and to know in a disease as serious as C3G or IC-MPGN, efficacy is what will really matter. More than convenient straight, whether you take a pill or subcutaneous. If you have a real differentiation on efficacy, that is what we'll stand out.

但另一方面，如果我們在 VALIANT 中的數據確實很好，那麼就有真正的機會與 SYFOVRE 區分開來，並且知道在像 C3G 或 IC-MPGN 這樣嚴重的疾病中，療效才是真正重要的。無論您服用藥丸還是皮下注射，都比直接方便更方便。如果您在功效上有真正的差異化，那麼我們就會脫穎而出。

I also want to point out, of course, we've always talked about the remarkable safety profile that we've seen in PNH and the other indications where SYFOVRE has been used and is on the market, combined with this extraordinary compliance rate of 97%. SYFOVRE, which has the same active ingredient as SYFOVRE is an amazing drug and hopefully in Valeant, we will see a new indication emerge for that drug.

當然，我還想指出的是，我們一直在談論我們在 PNH 中看到的卓越的安全性以及 SYFOVRE 已使用並上市的其他跡象，再加上 97 的非凡合規率%。SYFOVRE 與 SYFOVRE 具有相同的活性成分，是一種令人驚嘆的藥物，希望在 Valeant 中，我們將看到該藥物出現新的適應症。

Annabel Eva Samimy, Stifel.

安娜貝爾·伊娃·薩米米，斯蒂菲爾。

So, I guess in our channel checks, we're happy to find that consensus among these physicians we spoke to is generally in line with your comments that physicians give SYFOVRE that edge on efficacy. I guess my question is, how are they responding to the micropurgatory data? Because it's not something that they typically do in their offices. So how can they use that with their patients practically so they can show patients benefit over time and keep them motivated?

因此，我想在我們的管道檢查中，我們很高興地發現我們採訪過的這些醫生之間的共識總體上與您的評論一致，即醫生給予 SYFOVRE 在功效上的優勢。我想我的問題是，他們對微煉獄資料有何反應？因為這不是他們通常在辦公室做的事情。那麼，他們如何在患者身上實際運用這項技術，以便向患者展示隨著時間的推移所帶來的益處並保持他們的積極性呢？

And I ask that, I guess for retention beyond that, say, 18 months to two year timeframe where patients may start dropping off? Do they have the tools right now? And are they starting to adopt some of these tools so they can demonstrate to their patients that this is working? Thanks.

我想問一下，我想如果保留超過這個時間，例如 18 個月到兩年的時間，患者可能會開始脫落？他們現在有工具嗎？他們是否開始採用其中一些工具，以便向患者證明這是有效的？謝謝。

Thank you, Annabel. Adam is going to first answer the first question.

謝謝你，安娜貝爾。Adam 先回答第一個問題。

So, I appreciate your comments on efficacy. We also did a recent piece of market research, and we noticed in our sentiment to our market research that our efficacy perception is increasing and there's a gap between us and the competitor in our market research. So, it seems to confirm what you said.

所以，我很欣賞你對功效的評論。我們最近也做了一項市場研究，我們注意到我們對市場研究的看法是，我們的功效認知正在增加，我們與市場研究的競爭對手之間存在差距。所以，看來證實了你說的話。

I'll hand over to Caroline on micropurgatory.

我會把微煉獄的事情交給卡洛琳。

Thank you, Adam. Physicians are really excited about the micropurgatory data. And in showing them, they see the trend in the micropurgatory data that's followed over time and that it reaches this pre-specified endpoint. I think that most physicians, realize that micropurgatory in many ways is analogous to a visual field testing, and they appreciate that it shows benefit in a clinical trial.

謝謝你，亞當。醫生們對微煉數據感到非常興奮。在向他們展示時，他們看到了隨著時間的推移微煉資料的趨勢，並且它達到了預先指定的終點。我認為大多數醫生都意識到微煉在許多方面類似於視野測試，並且他們意識到它在臨床試驗中顯示出益處。

But in the real world, they like to use OCT, which also, has shown benefits using our AI algorithms combined with the University of -- . So, I think the fact that we have this prespecified endpoint though is very highly meaningful, and it will mostly be used today in clinical studies, although some people are using micropurgatory in the real world.

但在現實世界中，他們喜歡使用 OCT，這也顯示了使用我們的人工智慧演算法與大學結合的好處——。因此，我認為我們有這個預先指定的終點這一事實非常有意義，並且它今天將主要用於臨床研究，儘管有些人在現實世界中使用微煉獄。

In the real world, we can use imaging to show this to patients, and we have cases that we've shown to physicians. In fact, we showed one at ASRS where, a patient in the observed fellow eye, the geographic atrophy grew 3 times as much compared to the treated eye. So, cases like this are highly meaningful, and that was in Matt McCumber's video talk at ASMS.

在現實世界中，我們可以使用成像向患者展示這一點，並且我們已經向醫生展示了案例。事實上，我們在 ASRS 上展示了一個患者的觀察結果，其中一名患者的另一隻眼睛的地理萎縮比接受治療的眼睛增長了 3 倍。所以，像這樣的案例非常有意義，這就是 Matt McCumber 在 ASMS 的視訊演講中提到的。

François Brisebois, Oppenheimer.

弗朗索瓦·布里斯布瓦，奧本海默。

Thanks for the question here. So, I was just wondering, so in terms of function we've discussed, but on convenience and the importance of that and the economic value, can you help us understand a little bit from the convenience. Is that as advantages to the physician as it is to the patient? I'm just trying to understand if convenience and economic value here have a correlation or not?

謝謝你在這裡提問。所以，我只是想知道，就我們討論過的功能而言，但是就便利性及其重要性以及經濟價值而言，您能否從便利性方面幫助我們理解一點。這對醫生和病人來說都是有利的嗎？我只是想了解這裡的便利性和經濟價值是否有關聯？

Well, there's three pieces to that question. There's the convenience to the patient, convenience to the physician, and then the convenience, quite frankly to the payer. So, when we start with the convenience to the patient, having every other month dosing available is really important. Our competitor, sure there is some off-label use with every other month, but our competitor has only monthly. We're going to find out at the end of this year if they actually ever get every other month in their label. This is a huge point of differentiation that we will benefit meaningfully from should end up the way we think.

嗯，這個問題分為三個部分。首先是對病人的便利，對醫生的便利，然後是對付款人的便利。因此，當我們從方便患者開始時，每隔一個月給藥一次非常重要。我們的競爭對手，當然每隔一個月就有一些標籤外使用，但我們的競爭對手只有每月一次。我們將在今年年底知道他們是否真的每隔一個月就進入他們的標籤。這是一個巨大的差異化點，如果最終像我們想像的那樣，我們將從中受益匪淺。

The advantage to physicians of every other month is, again, the flexibility. And I'm going to let Caroline answer like her view on that and then have Adam dive into the payer aspect of the cost, the value.

對醫生來說，每隔一個月的優勢再次在於靈活性。我將讓卡羅琳回答她對此的看法，然後讓亞當深入探討成本和價值的付款人方面。

Certainly, to realize the anatomic benefits of SYFOVRE, we've seen that every other month dosing is meaningful. And I think that with our flexible every 25 to 60 days in our label, patients can come every six to eight weeks and still realize these meaningful effects.

當然，為了實現 SYFOVRE 的解剖學優勢，我們發現每隔一個月給藥一次是有意義的。我認為，透過我們標籤中每 25 至 60 天一次的靈活治療，患者可以每六至八週來一次，並且仍然能夠實現這些有意義的效果。

And certainly, in the US physicians love to have that plus minus one to two weeks with their dosing. And it's more likely for patients to come in and complete this. We know that with monthly dosing from our anti-VEGF experience, it's really very difficult to complete that and patients will often drop out because they cannot maintain that. Adam?

當然，在美國，醫生喜歡在服藥時縮短一到兩週的時間。患者更有可能來完成這個任務。我們知道，根據我們的抗 VEGF 經驗，每月一次給藥確實很難完成，患者常常會因為無法維持而退出。亞當？

So obviously, we were we're thrilled that some payers are starting to look at this category and selecting SYFOVRE referred choice. So, this decision was basically made on its robust efficacy profile and particularly the increasing effects over time. And I think it's really basically simple. SYFOVRE is efficacious with monthly and every other month doses, and this is good for patients and is economically supportive for the health plan. And I think that's going to be important for us as this market continues to grow and become bigger.

顯然，我們很高興一些付款人開始關注此類別的並選擇 SYFOVRE 推薦的選擇。因此，這項決定基本上是基於其強大的功效，特別是隨著時間的推移而增加的效果。我認為這基本上很簡單。SYFOVRE 在每月和每隔一個月的劑量下有效，這對患者有好處，並且在經濟上支持健康計劃。我認為隨著這個市場的不斷成長和擴大，這對我們來說非常重要。

And context there is that the flexibility is everything. Some patients with aggressive lesions want to be dosed monthly. We have seen very clearly in GALE as well that there are advantages to treating monthly. I mean, it is more intense from a dosing perspective of course, but in terms of reducing the lesion growth, there is an advantage to monthly. So that flexibility, the huge amount of data that we have both in its absolute but also longitudinally over time. We have three years now, we will have more data coming, all of that's incredibly valuable.

背景是靈活性就是一切。一些患有侵襲性病變的患者希望每月接受一次給藥。我們在 GALE 中也非常清楚地看到每月治療的優勢。我的意思是，當然從劑量的角度來看它更強烈，但在減少病變生長方面，每月有一個優勢。因此，靈活性是我們擁有的大量數據，既有絕對數據，也有縱向數據。現在還有三年時間，我們將獲得更多數據，所有這些都非常有價值。

And just lastly on the VALIANT data, just because it's coming up very shortly here. You guys discussed in terms of success and expectations stats on the primary, but on the secondary in terms of, is this the positive trend on some secondary endpoints or all? And is this what the regulators need to see from conversations? They're just trying to understand more on the secondary endpoints and points here.

最後是 VALIANT 數據，因為它很快就會出現。你們討論了主要方面的成功和期望統計數據，但在次要方面，這是某些次要終點或全部的積極趨勢嗎？這是監管機構需要從對話中看到的嗎？他們只是想更多地了解這裡的次要終點和點。

The secondary endpoints, needs to trend supportive of the primary endpoint. And we have seen this with VALIANT, where none of the secondary endpoints were met. But where we believe there is still a path forward for VALIANT. They were specifically asked to submit the data at one year as you may recall after having the six-month primary endpoint. Those are all things, secondary endpoints are more contextual, but very important to provide support to what we measure with the primary endpoint and the -- area reductions.

次要終點需要支持主要終點的趨勢。我們在 VALIANT 中看到了這一點，其中沒有達到任何次要終點。但我們相信 VALIANT 仍有前進的道路。您可能還記得，在獲得六個月的主要終點後，他們被特別要求在一年後提交資料。這些都是事情，次要終點更具上下文性，但對於為我們通過主要終點和麵積減少測量的結果提供支持非常重要。

Douglas Tsao, H.C. Wainwright.

雪兒 (Douglas Tsao)溫賴特。

Hi. Good morning. Thanks for taking the questions. I'm just curious, Adam, in terms of the patients that are now being treated, -- I think in the past you indicated that like 90% of them had, were already on the books of retina specialists. I'm just curious if that continues to be the case.

你好。早安.感謝您提出問題。我只是很好奇，亞當，就目前正在接受治療的患者而言，--我想您過去曾指出，其中 90% 的患者已經接受過視網膜專家的治療。我只是好奇這種情況是否會持續下去。

And then in terms of the DTC work that you have done, for the most part, I think the Henry Winkler campaign has sort of been an unbranded campaign. Does there come a point where you might consider, now that you're quote on sort of in Phase 2, switch to a branded DTC effort to sort of focus on the competitive dynamics and the attributes of SYFOVRE versus Izervay?

然後就您所做的 DTC 工作而言，在很大程度上，我認為亨利溫克勒 (Henry Winkler) 的活動在某種程度上是一場無品牌的活動。現在，您是否會考慮在第二階段中進行報價，轉向品牌 DTC 工作，以關注 SYFOVRE 與 Izervay 的競爭動態和屬性？

So yes, this is obviously a large in growing market with 13% market penetration for the current approved therapies. And most of those patients, in fact, the vast majority of those patients were already on the books of retina specialists. So, they're tapping into the patients that have GA that they were perhaps seeing that had other complications, for example. One thing, Phase 2 of our plan is super critical and DTC is also a part of it, is that we are going to educate ophthalmologists and optometrists on geographic atrophy as a disease. And once you start to educate those physicians, they will be able to potentially refer viable patients to retina specialists for treatment.

所以，是的，這顯然是一個不斷增長的巨大市場，目前批准的療法的市場滲透率為 13%。事實上，這些患者中的大多數，絕大多數已經在視網膜專家的治療記錄中。因此，他們正在研究那些可能患有 GA 的患者，例如，他們可能會看到有其他併發症的患者。我們計劃的第二階段非常關鍵，DTC 也是其中的一部分，我們將教育眼科醫生和驗光師了解地理萎縮作為一種疾病。一旦你開始教育這些醫生，他們將有可能將可行的患者轉介給視網膜專家進行治療。

We see this as a really big market, and actually facilitating that education is only going to help us. So, DTC, Doug, yes, Henry Winkler was disease education. It was incredibly well received by patients but also by physicians. We did transition as part of Phase 2 to branded DTC. So, Henry was educating the world about go and get your eyes checked. And branded DTC is talking about SYFOVRE and the benefits of the efficacy that SYFOVRE does.

我們認為這是一個非常大的市場，實際上促進教育只會對我們有幫助。所以，DTC、道格，是的，亨利溫克勒就是疾病教育。它受到患者和醫生的熱烈歡迎。作為第二階段的一部分，我們確實過渡到品牌 DTC。所以，亨利正在教育全世界檢查你的眼睛。品牌 DTC 正在談論 SYFOVRE 以及 SYFOVRE 功效的好處。

So that patients are educated on the disease and then they can go and ask a physician to have a conversation about something. As we progress, moving forward, we're going to push DTC with a real strong approach on actual SYFOVRE and there's some exciting things happening with Henry moving forward.

這樣患者就可以接受有關該疾病的教育，然後他們可以去詢問醫生以討論一些問題。隨著我們的進步和前進，我們將在實際的 SYFOVRE 上採用真正強有力的方法來推動 DTC，隨著 Henry 的前進，會發生一些令人興奮的事情。

Biren Amin, Piper Sandler.

比倫·阿明，派珀·桑德勒。

Thanks for taking my question. Maybe if I could start with the competitive dynamic. Astellas earlier today on their call stated that they're seeing Izervay capturing a majority of new patients starts. Are you seeing similar trends from your treatment use and market research data?

感謝您提出我的問題。也許我可以從競爭動態開始。安斯泰來今天稍早在電話會議上表示，他們看到 Izervay 吸引了大部分新患者。您是否從治療使用和市場研究數據中看到了類似的趨勢？

So we are seeing through our dataset, which is not market research. We use a dataset that actually tracks vials into a physician site and then into a patient. So, we believe in the robustness of this, but we could do market research. And I think you get some bias when you do market research.

所以我們正在查看我們的數據集，這不是市場研究。我們使用的數據集實際上追蹤小瓶進入醫生站點，然後進入患者。因此，我們相信這一點的穩健性，但我們可以進行市場研究。我認為當你進行市場研究時你會產生一些偏見。

And with the headwinds the competitors have, we were still maintaining approximately 50% share of new starts. And I think that's really strong considering it was the quarter of their J-Code. So that's how we look at the data set. We believe 75% market share of total market is a very robust number, and we look to the future of how big this market can be and being the number one GA product in it.

儘管面臨競爭對手的不利影響，我們仍保持著約 50% 的新開工份額。考慮到這是他們 J 代碼的四分之一，我認為這真的很強大。這就是我們看待資料集的方式。我們相信佔整個市場 75% 的市佔率是一個非常強勁的數字，我們期待這個市場的未來有多大，並成為其中排名第一的 GA 產品。

That's helpful in terms of data point. And then maybe if I could have a follow up. So, on the quarter, it seems commercial units grew about 10% quarter-over-quarter, if you take out samples, but sales grew about 12% quarter-over-quarter. So is the remainder from lower gross to net in the quarter? And what should we expect for gross to net for the third quarter?

這在數據點方面很有幫助。然後也許我可以跟進一下。因此，如果你拿出樣本來看，本季商業單位似乎較上季成長了約 10%，但銷售額較上季成長了約 12%。那麼，本季毛額下降到淨額下降的剩餘部分是什麼呢？我們對第三季的毛淨額預期應該是多少？

So gross to net, obviously, we don't say exactly what gross to net is. It did go up slightly this quarter, but was really well within the range of where it was last quarter. And in terms of the files out, that those are the accurate numbers, and we don't tag -- numbers.

因此，顯然，我們並沒有確切說明淨收入是多少。本季度確實略有上升，但確實在上個季度的範圍內。就輸出的檔案而言，這些是準確的數字，我們不會標記數字。

Graig C. Suvannavejh, Mizuho Securities.

Graig C. Suvannavejh，瑞穗證券。

I just wanted to follow-up on earlier in the year comments around seasonality and how that impacted the first quarter in particular. I'm just wondering as you've got second quarter now behind you, if you can provide us any commentary on what you're expecting, if anything, around seasonality impacts in the third quarter and fourth quarter just as we think about modeling, SYFOVRE revenue on the go forward basis? Thanks.

我只是想跟進今年早些時候有關季節性的評論，以及它對第一季的影響。我只是想知道，由於第二季已經過去，您是否可以向我們提供任何評論，說明您對第三季和第四季季節性影響的預期（如果有的話），就像我們考慮建模一樣， SYFOVRE 的營收是否會持續成長？謝謝。

So obviously seasonality is an important metric to measure here. Every time we go to a big retina conference like ASRS a couple of weeks ago, right, a large proportion of physicians are there. So, there are multiple meetings moving forward, where physicians will be attending those conferences and learning about our efficacy data. Caroline, anything you want to add from your retina physician perspective?

顯然，季節性是這裡衡量的重要指標。幾週前，每次我們參加像 ASRS 這樣的大型視網膜會議時，都會有很大比例的醫生參加。因此，未來還會有多個會議，醫生將參加這些會議並了解我們的療效數據。卡羅琳，從您的視網膜醫生的角度來看，您有什麼需要補充的嗎？

The retina physicians are really looking forward. We have some upcoming exciting presentations, and they want to offer patients a product that's going to be effective with increasing effects over time. So, they are very motivated and looking forward to working with us on analyzing the data.

視網膜醫生真的很期待。我們即將進行一些令人興奮的演示，他們希望為患者提供一種有效的產品，並且隨著時間的推移效果會不斷增強。因此，他們非常積極並期待與我們合作分析數據。

And just as a follow-up is anything on like purchasing patterns, seasonally, third quarter versus fourth quarter -- bigger picture?

正如後續行動一樣，購買模式、季節性、第三季與第四季的情況如何——更大的前景？

I don't think we've had enough experience yet to really say that, at least in our in terms of this market. Anti-VEGF, there isn't anything that stands out particularly. I mean obviously you have August and that can be a full month just because vacation is booked. There's nothing really dramatic. --

我認為我們還沒有足夠的經驗來真正這麼說，至少在我們這個市場方面是如此。抗VEGF，沒有特別突出的。我的意思是顯然你有八月，這可能是整整一個月，因為假期已經預訂了。沒有什麼真正戲劇性的。--

Thank you. And I'm sure as I said, there is no further questions. And I would like I turn the conference back over to Cedric Francois for any further remarks.

謝謝。我確信正如我所說，沒有其他問題了。我希望將會議轉回給塞德里克·弗朗索瓦，以便他可以發表進一步的評論。

Thank you, operator. Thank you, everyone for joining us this morning. If you have any follow-up questions, please feel free to reach out to Meredith, and we look forward to hearing and speaking with many of you today. Thank you.

謝謝你，接線生。謝謝大家今天早上加入我們。如果您有任何後續問題，請隨時聯繫梅雷迪思，我們期待今天與您中的許多人進行聆聽和交談。謝謝。

That concludes today's conference call. Thank you for participating, and you may now disconnect.

今天的電話會議到此結束。感謝您的參與，您現在可以斷開連接。