ACADIA Pharmaceuticals Inc (ACAD) 2025 Q2 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the ACADIA Pharmaceuticals conference call. My name is Gerald, and I'll be your host for today.

女士們、先生們，大家好，歡迎參加 ACADIA Pharmaceuticals 電話會議。我叫傑拉爾德，今天我將擔任主持人。

I would now like to turn the conference over to Al Kildani, Senior Vice President of Investor Relations and Corporate Communications at ACADIA. Please proceed.

現在，我想將會議交給 ACADIA 投資者關係和企業傳播資深副總裁 Al Kildani。請繼續。

Thank you. Good afternoon and thank you for joining us on today's call to discuss ACADIA's second quarter 2025 financial results.

謝謝。下午好，感謝您參加今天的電話會議，討論 ACADIA 2025 年第二季的財務表現。

Joining me on the call today from ACADIA are Catherine Owen Adams, our Chief Executive Officer, who will provide some opening remarks; followed by Tom Garner, our Chief Commercial Officer, who will discuss our commercial brands DAYBUE and NUPLAZID.

今天，與我一起參加 ACADIA 電話會議的還有我們的執行長 Catherine Owen Adams，她將致開幕詞；隨後是我們的首席商務官 Tom Garner，他將討論我們的商業品牌 DAYBUE 和 NUPLAZID。

Also joining us today is Elizabeth Thompson, PhD Executive Vice President, Head of Research and Development, who will provide an update on our pipeline programs; and Mark Schneyer, our Chief Financial Officer, who will review the financial highlights. Catherine will then provide some closing thoughts before we open up the call for your questions.

今天與我們一起出席的還有執行副總裁兼研發主管 Elizabeth Thompson 博士，她將介紹我們的管道計劃的最新進展；我們的財務長 Mark Schneyer 將回顧財務亮點。在我們開始回答大家的提問之前，凱瑟琳將會發表一些總結性的評論。

We are using supplemental slides which are available on our website's events and presentations section. Before proceeding, I would like to remind you that during our call today, we will be making several forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

我們正在使用我們網站的活動和演示部分提供的補充幻燈片。在繼續之前，我想提醒您，在今天的電話會議中，我們將根據 1995 年《私人證券訴訟改革法案》的含義做出幾項前瞻性陳述。

These forward-looking statements, including goals, expectations, plans, prospects, growth potential, timing of events, future results, and 2025 financial guidance, are based on current information, assumptions, and expectations that are inherently subject to change and involve several risks and uncertainties that may cause results to differ materially.

這些前瞻性陳述，包括目標、期望、計劃、前景、成長潛力、事件時間、未來結果和 2025 年財務指導，均基於當前資訊、假設和期望，這些資訊、假設和期望本質上可能會發生變化，並涉及可能導致結果出現重大差異的若干風險和不確定性。

These factors and other risks associated with our business can be found in our filings made with the SEC. You are cautious not to place undue reliance on these forward-looking statements, which are made only as of today's date, and we assume no obligation to update or revise these forward-looking statements as circumstances change, except as required by law.

這些因素以及與我們的業務相關的其他風險可以在我們向美國證券交易委員會提交的文件中找到。請謹慎，不要過度依賴這些前瞻性陳述，這些陳述僅在今天做出，並且我們不承擔隨著情況變化而更新或修改這些前瞻性陳述的義務，除非法律要求。

I'll now turn the call over to Catherine for opening remarks.

現在我將把電話轉給凱瑟琳，請她致開幕詞。

Thank you, Al, and good afternoon, everyone. Our second quarter performance reinforces the momentum we're building across all facets of our business, from commercial strength to our clinical pipeline and global expansion.

謝謝你，艾爾，大家下午好。我們第二季的業績鞏固了我們在業務各個方面（從商業實力到臨床產品線和全球擴張）所建立的勢頭。

We delivered total revenue of $264.6 million this quarter, driven by strong growth across our portfolio. This includes $96.1 million from DAYBUE with patient uptake continuing to grow for the second successive quarter. And $168.5 million from NUPLAZID fostered by new patient starts and commercial execution.

本季度，我們實現了 2.646 億美元的總收入，這得益於我們投資組合的強勁成長。其中包括來自 DAYBUE 的 9,610 萬美元，患者數量連續第二季持續成長。NUPLAZID 透過新患者開始和商業執行籌集了 1.685 億美元。

DAYBUE has now passed stabilization, moved into growth and is entering a new phase, expansion and acceleration. Our investments in patient support, community engagement, and field expansion are starting to make a positive impact, as Tom will highlight in more detail.

DAYBUE 現已度過穩定期，進入成長期，並正在進入新的階段，即擴張和加速。我們在患者支持、社區參與和領域擴展方面的投資開始產生積極影響，湯姆將更詳細地介紹這一點。

On NUPLAZID we're encouraged by continued growth across all leading indicators, bolstered by recent litigation winds enforcing our intellectual property. These victories validate our long-term strategy and reinforce our ability to deliver NUPLAZID to patients through 2038.

在 NUPLAZID 上，我們對所有領先指標的持續成長感到鼓舞，這得益於最近強制執行我們智慧財產權的訴訟風潮。這些勝利驗證了我們的長期策略，並增強了我們在 2038 年之前向患者提供 NUPLAZID 的能力。

Our full year revenue guidance reflects this confidence. We are raising the low end of our NUPLAZID guidance based upon a foundation of disciplined execution and momentum delivered by our DTC campaigns.

我們的全年收入預期反映了這種信心。我們根據 DTC 活動帶來的嚴格執行和動力基礎，提高了 NUPLAZID 指導的低階。

We also hosted our first R&D Day, a milestone event that showcased our exciting and expanding pipeline. With 9 disclosed programs in development and 5 Phase, 2 or Phase 3 data readouts expected through 2027, 6, 5 more within ACADIA is palpable.

我們還舉辦了首屆研發日，這是一個里程碑式的活動，展示了我們令人興奮且不斷擴大的產品線。目前已揭露的開發案有 9 個，預計到 2027 年將有 5 個階段、2 個或 3 個階段的數據讀數，ACADIA 內還將有 6 個、5 個項目。

This will walk you through that shortly. First, let's start with commercial. Over to Tom.

這將很快引導您完成該操作。首先，我們從商業開始。交給湯姆。

Thanks, Catherine. Let's begin with DAYBUE. Q2 sales were $96.1 million, up 14% from a year ago. We observed steady progress across key performance metrics in the quarter. In Q2, 987 unique patients in the US received paid shipments, increasing from 954 in Q1 and 920 in Q4 2024.

謝謝，凱瑟琳。讓我們從 DAYBUE 開始。第二季銷售額為 9,610 萬美元，比去年同期成長 14%。我們觀察到本季關鍵績效指標穩步取得進展。第二季度，美國有 987 名獨立患者收到了付費發貨，較 2024 年第一季的 954 名和第四季度的 920 名有所增加。

The upward trend reflects encouraging signs of growth in both new patient starts and persistency. Long-term persistency remains a key strength for DAYBUE. Our 12 month persistency rate continues to exceed 50%, and we're now pleased to report that our 18 month persistency rate is above 45%.

這一上升趨勢反映出新患者數量和患者堅持率均出現了令人鼓舞的成長跡象。長期堅持仍然是 DAYBUE 的關鍵優勢。我們的 12 個月堅持率持續超過 50%，現在我們很高興地報告，我們 18 個月的堅持率已超過 45%。

This trend reflects the growing and stable base of patients who remain on therapy over time. When we look at lengths of treatment among patients currently on therapy, 70% have been on treatment for at least 12 months, highlighting the sustained benefits that DAYBUE continues to deliver and the durability of our growing patient base.

這一趨勢反映出接受治療的患者群體隨著時間的推移而不斷增長且穩定。當我們查看目前接受治療的患者的治療時間時，70％ 的患者已經接受了至少 12 個月的治療，這凸顯了 DAYBUE 持續帶來的持續益處以及我們不斷增長的患者群的持久性。

Notably, we're seeing more new prescriptions from the community setting, signaling progress in broading reach beyond academic centers, which was a key element of our field force expansion, which is now complete.

值得注意的是，我們看到了更多來自社區環境的新處方，這標誌著我們在擴大學術中心以外的影響力方面取得了進展，這是我們實地力量擴張的關鍵要素，目前該擴張已經完成。

We finished hiring and training earlier this quarter, and we're already seeing encouraging signs that the new customer model is gaining traction. One of the most promising indicators in the second quarter is a meaningful uptake in our proportion of new referrals coming outside of centers of excellence, where a majority of Rett patients receive their primary treatment.

我們在本季早些時候完成了招募和培訓，我們已經看到令人鼓舞的跡象，表明新的客戶模式正在獲得關注。第二季最有希望的指標之一是，來自卓越中心以外的新轉診患者比例顯著上升，大多數 Rett 患者在卓越中心接受主要治療。

Encouragingly, this increase was underpinned by a further increase in the number of new community-based writers for DAYBUE, with 900 total HCPs now having written. Additionally, we launched a direct consumer campaign for DAYBUE in July, and we are already seeing positive signs of early engagement from the Rett community.

令人鼓舞的是，DAYBUE 社區新作家數量的進一步增加支撐了這一增長，目前共有 900 名 HCP 參與寫作。此外，我們在 7 月針對 DAYBUE 發起了一項直接消費者活動，並且我們已經看到了 Rett 社區早期參與的積極跡象。

During Q2, we welcomed Allyson McMillan-Youngblood, a Senior Vice President of our Rare Disease Franchise. Allyson brings a breadth of commercial experience across the US biopharma business, including many launches. Her leadership will help to drive this critical business forward.

在第二季度，我們迎來了罕見疾病特許經營高級副總裁 Allyson McMillan-Youngblood。Allyson 為美國生物製藥行業帶來了豐富的商業經驗，包括許多產品的發布。她的領導將有助於推動這項重要業務向前發展。

As we look ahead with the expanded team now in place, we're continuing to execute against our strategy to drive long-term sustainable growth for DAYBUE. We expect this will translate into an increase in new patient starts towards the back end of the year.

展望未來，隨著團隊的擴大，我們將繼續執行我們的策略，推動 DAYBUE 的長期永續成長。我們預計這將意味著今年年底新患者數量的增加。

At the International Rett Syndrome Foundation meeting in June, our presence as a leader in the Rett therapy field was felt. As Liz will detail, we shared multiple compelling posters that add to the body of evidence for DAYBUE.

在六月舉行的國際雷特症候群基金會會議上，人們感受到了我們作為雷特療法領域領導者的地位。正如 Liz 所詳述的，我們分享了多張引人注目的海報，為 DAYBUE 提供了更多證據。

Let's now turn our plans to trofinetide outside the US. In the EU, where the prevalent population, it's estimated to be between 9,000 to 12,000 Rett patients, name patient supply as requested by local HCPs is available through Clinigen.

現在讓我們將計劃轉向美國以外的 Trofinetide。在歐盟，雷特氏症的患病人口估計在 9,000 至 12,000 人之間，可透過 Clinigen 獲得當地 HCP 要求的患者姓名供應。

We've received requests from multiple countries and are continuing to support patients where regulatory frameworks allow. Name patient supply based upon HCP request is also in place in Israel through Rafah and in selective rest of world countries through FarmaMondo.

我們收到了來自多個國家的請求，並在監管框架允許的情況下繼續為患者提供支援。以色列也透過 Rafah 提供基於 HCP 請求的病人姓名供應，而世界其他特定國家則透過 FarmaMondo 提供。

Overall, we're pleased with the continued momentum of DAYBUE in the US and with the global interest in trofinetide, where we have already started serving patients through these programs.

總體而言，我們對 DAYBUE 在美國持續發展勢頭以及全球對曲芬奈肽的興趣感到高興，我們已經開始透過這些計畫為患者提供服務。

Now turning to NUPLAZID, our commercial clean delivered another strong quarter with revenue of $168.5 million, up 7% from a year ago, driven primarily by volume. We saw strength across all key metrics in Q2. Referrals were up 17% year over year, driven by continued momentum in our direct consumer campaign.

現在轉向 NUPLAZID，我們的商業清潔業務又取得了強勁的季度業績，收入達到 1.685 億美元，比去年同期增長 7%，主要受銷量推動。我們看到第二季所有關鍵指標均表現強勁。受直接消費者活動持續強勁推動，推薦量較去年同期成長 17%。

As a result, for the first time ever, both referrals and new prescriptions increased sequentially from Q1 to Q2. Another of the quarter's highlights was shipping the highest number of NUPLAZID bottles since launch, a strong indicator of growing demand as we continue educating both healthcare providers and patients with PDP about the product's unique and differentiated profile.

因此，有史以來第一次，從第一季到第二季度，轉診量和新處方量均連續增加。本季度的另一個亮點是 NUPLAZID 瓶裝藥的出貨量達到了自推出以來的最高水平，這有力地表明了需求的增長，因為我們將繼續向醫療保健提供者和 PDP 患者宣傳該產品的獨特和差異化特性。

The DTC campaigns are doing exactly as we intended. Sparking meaningful conversations with healthcare providers and reinforcing our commitment to educating caregivers about the symptoms of hallucinations and delusions related to Parkinson's disease.

DTC 活動的進展正如我們預期的那樣。與醫療保健提供者進行有意義的對話，並加強我們對教育護理人員有關帕金森氏症相關的幻覺和妄想症狀的承諾。

Visits to NUPLAZID.com have surged with a 17-fold increase in consumer traffic year over year, helping to drive more patients to speak with their physicians. To carry this momentum forward, we're pleased to extend our agreement with Ryan Reynolds and the More to Parkinson's campaign through February of 2026.

NUPLAZID.com 的訪問量激增，消費者流量年增了 17 倍，有助於吸引更多患者與醫生交談。為了延續這一勢頭，我們很高興將與瑞安·雷諾茲和 More 的帕金森氏症防治活動協議延長至 2026 年 2 月。

The campaign continues to drive meaningful awareness of hallucinations and delusions in Parkinson's disease, and we believe a strong push through year-end is essential to build on that success. This quarter's NUPLAZID results reflect the strong executional focus of our field teams, coupled with the ongoing positive impact of our DTC efforts. Taken together, we expect to see sustained growth through the second half of the year and beyond.

這項活動將繼續提高人們對帕金森氏症幻覺和妄想症的認識，我們相信，年底的強力推動對於鞏固這一成功至關重要。本季的 NUPLAZID 表現反映了我們現場團隊強大的執行力，以及我們 DTC 努力的持續正面影響。總的來說，我們預計今年下半年及以後將持續成長。

And with that, I'll hand it to Liz to review our pipeline progress.

有了這些，我會把它交給 Liz 來審查我們的管道進度。

Thank you, Tom. Let me begin by revisiting the highlights from our inaugural R&D Day held in New York on June 25, where we showcased the strength and breadth of our pipelines. We were pleased with how the event came together, and I want to thank many of you on this call who were able to join us.

謝謝你，湯姆。首先，讓我回顧一下 6 月 25 日在紐約舉行的首屆研發日的亮點，我們在會上展示了我們產品線的實力和廣度。我們對這次活動的順利進行感到非常高興，我想感謝在座的各位能夠參加這次活動。

Well, we had already disclosed all the programs on this chart, R&D Day gave us a great opportunity to provide more details, particularly for two newer molecules. The first is ACP-211, an orally administered, selectively deuterated form of R-Norketamine, which we're developing for the potential treatment of major depressive disorder.

好吧，我們已經在這張圖表上披露了所有項目，研發日給了我們一個很好的機會來提供更多細節，特別是對於兩個較新的分子。第一個是 ACP-211，一種口服的、選擇性氘化的 R-去甲氯胺酮，我們正在開發它用於治療重度憂鬱症。

Day to date, support the potential for efficacy without significant sedation or dissociation, a profile we will continue to explore in Phase 2 and beyond. The second is ACP-271, a GPR88 agonist with potential applications in Tardive Dyskinesia and Huntington's Disease.

到目前為止，支持了沒有明顯鎮靜或分離的療效潛力，我們將在第 2 階段及以後繼續探索這一點。第二種是 ACP-271，一種 GPR88 激動劑，在治療遲發性運動障礙和亨丁頓舞蹈症方面具有潛在應用。

This is some of the most novel biology in our pipeline, and we believe it to be the first GPR88 agonist that will enter clinical trials. If you weren't able to participate in our R&D day, I highly encourage you to visit our website where you can access the webcast and the full set of presentation slides.

這是我們研發管線中最新的生物學產品之一，我們相信它是第一個進入臨床試驗的 GPR88 激動劑。如果您無法參加我們的研發日，我強烈建議您造訪我們的網站，在那裡您可以存取網路廣播和全套簡報幻燈片。

The event was a clear demonstration of the momentum building across our pipeline. We're advancing with purpose and clarity, and the progress is tangible. Across our 9 disclosed programs, we anticipate initiating 7 Phase 2 or Phase 3 studies over the course of 2025 and 2026.

這項活動清楚地表明了我們整個管道的勢頭正在增強。我們正朝著目標明確、目標清晰的方向前進，而且取得了實際的進展。在我們揭露的 9 個項目中，我們預計將在 2025 年和 2026 年期間啟動 7 項第 2 階段或第 3 階段研究。

Moreover, between 2025 and 2027, we expect 5 Phase 2 or Phase 3 readouts. These milestones underscore both the breadth of our pipeline and the strength of our R&D strategy. Specifically, we have several important trial initiations and data readouts on the horizon.

此外，我們預計在 2025 年至 2027 年間將有 5 個第 2 階段或第 3 階段的讀數。這些里程碑凸顯了我們產品線的廣度和研發策略的實力。具體來說，我們即將啟動幾項重要的試驗並公佈數據。

In Q3 2025, we plan to initiate a Phase 2 study of ACP-204 in Lewy Body Dementia Psychosis. Also in the third quarter, we expect to initiate our Phase 3 study of trofinetide in patients with Rett syndrome in Japan.

2025 年第三季度，我們計劃啟動 ACP-204 治療路易氏體失智症的 2 期研究。此外，我們預計將在第三季在日本啟動針對雷特症候群患者的曲菲奈肽 3 期研究。

In early Q4 2025, we expect to report top line results from the COMPASS PWS Phase 3 study of ACP-101 in Prader-Willi syndrome following the completion of enrolment in Q2. Also in Q4 2025, we anticipate initiating a Phase 2 study of ACP-211 in major depressive disorder.

我們預計將於 2025 年第四季初報告 ACP-101 治療普拉德威利症候群的 COMPASS PWS 第三階段研究的頂線結果，該研究於第二季完成招募。此外，我們預計將在 2025 年第四季啟動 ACP-211 治療重度憂鬱症的 2 期研究。

Wrapping up the year, we plan to begin a first in human study of ACP-271 in healthy volunteers before year end. And finally, we also continue to progress through the review process with EMA for trofinetide, with agency decision expected in the first quarter of 2026.

今年年末，我們計劃在年底前對健康志願者進行首次 ACP-271 人體研究。最後，我們也將繼續推進 EMA 對曲芬奈肽的審查程序，預計該機構將於 2026 年第一季做出決定。

In addition to these upcoming milestones, we continue to make meaningful contributions to the scientific literature for our marketed and pipeline products. The second quarter was a busy one for ACADIA relevant medical meetings with major conferences for Rett syndrome, Prader-Willi syndrome, and Alzheimer's.

除了這些即將到來的里程碑之外，我們還將繼續為我們的市場和管道產品的科學文獻做出有意義的貢獻。第二季度，ACADIA 相關醫學會議非常繁忙，主要會議涉及雷特症候群、普拉德威利症候群和阿茲海默症。

First, there were multiple DAYBUE-related presentations at the International Rett Syndrome Foundation meeting, continuing to expand the body of evidence describing DAYBUE's long-term impact in the Rett community.

首先，國際雷特症候群基金會會議上有多個與 DAYBUE 相關的演講，繼續擴大描述 DAYBUE 對雷特社區的長期影響的證據。

Several posters focused on caregiver reported outcomes in real-world data, which importantly continue to align with what we have observed in clinical trials. Additionally, there were analyses evaluating treatment utilization in less commonly studied populations such as males and older patients.

幾張海報重點在於護理人員在現實世界數據中報告的結果，重要的是，這些結果與我們在臨床試驗中觀察到的結果一致。此外，還對男性和老年患者等研究較少的人群的治療利用情況進行了評估分析。

And finally, ACADIA shared an analysis of our clinical trial data suggesting that most patients who are going to benefit from DAYBUE show a response within six months, reinforcing our guidance to providers and caregivers.

最後，ACADIA 分享了我們臨床試驗數據的分析，表明大多數將從 DAYBUE 中受益的患者在六個月內會出現反應，這加強了我們對提供者和護理人員的指導。

Together, these data points reflect a growing and maturing evidence base that continues to shape how DAYBUE is understood and used in the real world. In the pipeline, both ACP-101 and ACP-204 teams had important meetings in the quarter.

總之，這些數據點反映了不斷增長和成熟的證據基礎，這些證據基礎將繼續影響 DAYBUE 在現實世界中的理解和使用方式。在管道方面，ACP-101 和 ACP-204 團隊在本季度都舉行了重要會議。

In Prader-Willi syndrome, the end of June marked the United in Hope meeting, the joining together of three separate PWS organizations in a combined meeting. Those of you who tuned in to R&D Day will recall that our PWS panel in part was live from United in Hope.

在普拉德-威利症候群方面，六月底舉行了「希望聯合」會議，這是三個獨立的 PWS 組織聯合召開的一次會議。那些收看研發日的人會記得，我們​​的 PWS 小組部分內容是從聯合希望現場直播的。

As we await data out of our Phase 3 trials, we nevertheless are contributing to the knowledge and understanding of PWS with posters about the experience of patients and families exploring comorbidities and the associated burden.

在我們等待 3 期試驗數據的同時，我們仍在透過海報分享患者和家屬對合併症和相關負擔的體驗，為增進對 PWS 的認識和理解做出貢獻。

In the Alzheimer's space, I'm also pleased to report multiple ACP-204 presentations at the Alzheimer's Association International Conference held last week in Toronto. This meeting represented a significant step in our public disclosure of detailed data from non-clinical and early stage clinical studies supporting ACP-204's attainment to date of its desired profile.

在阿茲海默症領域，我很高興地報告上週在多倫多舉行的阿茲海默症協會國際會議上的多場 ACP-204 演示。這次會議代表著我們在公開披露支持 ACP-204 迄今為止達到其預期效果的非臨床和早期臨床研究的詳細數據方面邁出了重要一步。

Presented data included the specificity for 5HT2A and the supported PK profile, indicating a faster time to steady state, support for daily dosing, the lack of QT prolongation, and the ability to dose with and without food.

呈現的數據包括 5HT2A 的特異性和支持的 PK 曲線，表明達到穩定狀態的時間更快、支持每日給藥、沒有 QT 延長以及在有或無食物的情況下給藥的能力。

We also shared clinical data primarily focused on the 60 milligram dose across several Phase 1 trials with supportive safety and tolerability profiles to date, including in healthy elderly subjects. Collectively, the data provides support for the potential utility of ACP-204 and key aspects of its target profile.

我們也分享了主要針對 60 毫克劑量的臨床數據，這些數據涵蓋了迄今為止在包括健康老年受試者在內的幾項 1 期試驗中獲得的支持性安全性和耐受性概況。總的來說，這些數據為 ACP-204 的潛在效用及其目標概況的關鍵方面提供了支持。

Lastly, I'll touch briefly on ACP 101, where we continue to expect top-line results in early Q4. Just as a reminder, this is a 12 week placebo-controlled parallel group study. That design is important because if successful, it would allow us to clearly describe for physicians and patients what to expect upon initiating therapy in a Prader-Willi syndrome patient population.

最後，我將簡要談談 ACP 101，我們將繼續預期第四季初的營收結果。提醒一下，這是一項為期 12 週的安慰劑對照平行組研究。這個設計很重要，因為如果成功，它將使我們能夠向醫生和患者清楚地描述在普拉德-威利症候群患者群體中開始治療時會發生什麼。

Should the data be positive, we anticipate being in a position to file in the first quarter of 2026, and we continue to anticipate that this will qualify as a resubmission with the FDA with the associated shorter potential review clock with the potential PDUFA date in the third quarter of 2026.

如果資料是正面的，我們預計將能夠在 2026 年第一季提交申請，並且我們繼續預計這將有資格向 FDA 重新提交，並且相關的潛在審查時間更短，潛在的 PDUFA 日期為 2026 年第三季。

And now I'll pass over to Mark for a financial overview of the quarter.

現在我將把主題交給馬克，讓他介紹本季的財務概況。

Thanks, Liz. Let's now review our second quarter, 2025 financial results. The second quarter was strong across the board with $264.6 million in total revenues of 9% year over year.

謝謝，莉茲。現在讓我們回顧一下 2025 年第二季的財務表現。第二季業績表現強勁，總營收達 2.646 億美元，年增 9%。

Second quarter DAYBUE net product sales of $96.1 million, represented 14% year over year growth, including 12% volume growth, primarily reflecting the increase in unique patients receiving shipments in the quarter. The DAYBUE gross the net adjustment for the quarter was 23.3%.

第二季 DAYBUE 淨產品銷售額為 9,610 萬美元，年增 14%，其中銷量成長 12%，主要反映了本季接收貨物的獨立患者數量的增加。DAYBUE 本季的淨調整總額為 23.3%。

Turning next to new closet, second quarter net product sales were $168.5 million, up 7% year over year, with 5% of that growth attributable to volume. The NUPLAZID gross to that adjustment for the quarter was 24.6%. R&D expenses were $78 million in the second quarter, up slightly from $76.2 million in the second quarter of 2024.

接下來是新衣櫥，第二季淨產品銷售額為 1.685 億美元，年增 7%，其中 5% 的成長歸因於銷售量。本季 NUPLAZID 的調整總額為 24.6%。第二季研發費用為 7,800 萬美元，略高於 2024 年第二季的 7,620 萬美元。

SG&A expenses for the second quarter were $133.5 million up from $117.1 million in the second quarter of 2024. The increase was primarily driven by increased expenditures for both DAYBUE and new closet in the US, including the planned expansion of the DAYBUE commercial team.

第二季的銷售、一般及行政費用為 1.335 億美元，高於 2024 年第二季的 1.171 億美元。成長的主要原因是 DAYBUE 和美國新衣櫥的支出增加，包括 DAYBUE 商業團隊的計畫擴張。

We ended the quarter with a cash balance of $762 million, up from $681.6 million at the end of Q1 and $756 million at the end of 2024.

本季末，我們的現金餘額為 7.62 億美元，高於第一季末的 6.816 億美元和 2024 年底的 7.56 億美元。

Let's turn to our 2025 guidance. We are raising the low end of our NUPLAZID guidance range reflecting the strength of the business and its performance to date. We now expect NUPLAZID net product sales for the year to be between $665 million and $690 million. This compares with our prior guidance range of $650 million to $690 million.

讓我們來看看 2025 年的指導。我們正在提高 NUPLAZID 指導範圍的低端，以反映該業務的實力及其迄今為止的表現。我們現在預計 NUPLAZID 今年的淨產品銷售額將在 6.65 億美元至 6.9 億美元之間。相較之下，我們先前預期的範圍為 6.5 億美元至 6.9 億美元。

Accordingly, we are also adjusting our US only total revenue guidance to reflect this change. As you can see on the slide, we are reiterating all other prior guidance ranges from our Q1 call. We're confident in our ability to execute against these targets and to continue creating value for patients and shareholders.

因此，我們也調整了僅限美國的總收入指引以反映這一變化。正如您在幻燈片上看到的，我們重申了第一季電話會議中的所有其他先前指導範圍。我們有信心實現這些目標並繼續為患者和股東創造價值。

I'd now like to hand it back to Catherine for closing remarks.

現在我想把發言權交還給凱瑟琳，請她做最後的總結發言。

Thanks, Mark. As you've heard, quarter two was a quarter of progress and momentum. Our teams are executing with urgency and precision. And we remain focused on accelerating DAYBUE's commercial trajectory, sustaining long-term growth and differentiation for NUPLAZID, advancing a deep pipeline through rigorous clinical development, and continuing to build the pipeline through business development.

謝謝，馬克。正如您所聽到的，第二季度是取得進展和強勁發展的季度。我們的團隊正在緊急而精確地執行任務。我們將繼續致力於加速 DAYBUE 的商業發展軌跡，維持 NUPLAZID 的長期成長和差異化，透過嚴格的臨床開發推進深度產品線，並繼續透過業務發展建立產品線。

And expanding globally to reach more patients in need. The next major milestone is ACP-101's data readout in early Q4, and we're hopeful for what that could mean for families living with Prader-Willi syndrome. Thanks for joining today's call and thank you for your continued support of ACADIA.

並在全球擴張以惠及更多有需要的患者。下一個重要里程碑是第四季度初 ACP-101 的數據讀數，我們對這對患有普拉德-威利症候群的家庭意味著什麼充滿希望。感謝您參加今天的電話會議，也感謝您對 ACADIA 的持續支持。

And I'll now open it up for questions, operator.

接線員，現在我開始回答問題。

(Operator Instructions)

（操作員指示）

Tessa Romero, JP Morgan.

摩根大通的泰莎·羅梅羅 (Tessa Romero)。

Good afternoon, team. Thanks so much for taking our questions. So I actually wanted to ask about ACP-101 today. Liz, maybe could you orient us to the approach you plan to take with your top line? How much detail will you provide and will this be more qualitative or quantitative in nature?

大家下午好。非常感謝您回答我們的問題。所以我今天實際上想問一下 ACP-101。莉茲，也許你可以向我們介紹一下你計劃採取的銷售策略？您將提供多少細節？本質上是定性還是定量的？

And are there any secondary or other end points that you will think will matter beyond HQCT? And then as a follow up where are you really most focused from a clinical trial conduct perspective to manage any key risks thanks.

您認為除了 HQCT 之外，還有哪些次要或其他終點也很重要？然後作為後續問題，從臨床試驗實施的角度來看，您最關注的是什麼來管理任何關鍵風險，謝謝。

Thanks, Tess. Great question. So in terms of our approach to top line and for that matter in terms of our approach to how we're thinking about this trial, first and foremost is the primary endpoint and success there. We will be looking at our secondary endpoints, which are a combination of clinician assessments as well as a responder bar for the HQCT.

謝謝，苔絲。好問題。因此，就我們的頂線方法以及我們對這次試驗的看法而言，首先也是最重要的是主要終點和成功。我們將研究我們的次要終點，它是臨床醫生評估和 HQCT 響應者欄的組合。

As well in terms of what we're going to release, certainly I would anticipate that there would be a focus on the primary endpoint and sort of key overview of safety and tolerability and that's what you should anticipate out of our top line announcement.

至於我們將要發布的內容，我當然預計我們會重點關注主要終點以及安全性和耐受性的關鍵概述，這也是您應該從我們的頂線公告中期待的。

In terms of the areas that we are focusing on in terms of clinical trial conduct we have been -- throughout we have been robustly keeping on top of how the assessments appeared being performed and whether variability was within our expected area -- our expected ranges. So those are the areas that we've been focusing on in terms of conduct and making sure that we have as consistent a behavior as possible across the sites.

就我們在臨床試驗實施方面所關注的領域而言，我們一直在密切關注評估的執行情況以及變化是否在我們的預期範圍內 - 我們的預期範圍。因此，這些是我們在行為方面一直關注的領域，並確保我們在各個站點的行為盡可能保持一致。

Thanks, Liz. Thanks for the question, Tess.

謝謝，莉茲。謝謝你的提問，苔絲。

Ritu Baral, TD Cowen.

Ritu Baral，TD Cowen。

Good afternoon. Thanks for taking the question. I wanted to talk a little bit or ask a little bit about the new momentum in in DAYBUE. Could you tell us what percentage of patients or new patients specifically, came from the community setting and you mentioned the new number of 900 HCP writers, what percentage or at least movement of those writers were in the community setting on a quantitative basis and then I have a Prader-Willi follow up as well.

午安.感謝您回答這個問題。我想稍微談論一下或詢問一下有關 DAYBUE 的新勢頭。您能否告訴我們，具體有多少比例的患者或新患者來自社區環境？您提到了新的 900 名 HCP 作者，從數量上看，這些作者中有多少比例或至少有多少流動是在社區環境中，然後我也有一個 Prader-Willi 後續行動。

Thanks, Ritu. We'll take the DAYBUE question first. I'll ask Tom to give you some more details on that.

謝謝，Ritu。我們先來回答 DAYBUE 的問題。我會讓湯姆向您提供更多有關該問題的細節。

Perfect. Good afternoon, Ritu. Hope you're doing well. So in terms of your first question regarding the penetration that we've seen -- as a result of the increase in the sales force, which is a reminder that went live kind of through May.

完美的。下午好，Ritu。希望你一切都好。因此，關於您的第一個問題，關於我們所看到的滲透率——這是由於銷售團隊的增加，這是一個在五月開始的提醒。

So we're kind of fairly early on in terms of seeing the impact, but we're pleased with what we're seeing already. In the quarter we actually saw that the number of referrals that were coming directly from our non-COE accounts actually grew to about three quarters of our overall number.

因此，我們在看到影響方面還處於相當早期的階段，但我們對已經看到的結果感到滿意。在本季度，我們實際上看到直接來自非 COE 帳戶的推薦數量實際上增長到了總數的四分之三左右。

So that was up from about two-thirds the quarter before, which I think is a nice increase in terms of being able to penetrate that large group of patients that we know exist that fall outside of our COE. So just as a reminder roughly 65% of our patients fall outside the direct care of one of the COE centers, one of the COE designated centers.

因此，這一數字比上一季的三分之二有所上升，我認為，就能夠涵蓋我們所知道的、不屬於我們 COE 範圍的大量患者而言，這是一個不錯的增長。因此需要提醒的是，大約 65% 的患者不屬於 COE 中心（即 COE 指定中心）的直接照護範圍。

With regards to your second question as to the additional writers that we saw through Q2, the vast majority of those new writers fell outside of the COEs, which, given the fact that we saw this nice uptick in terms of penetration through the quarter. I think again it's a nice leading indicator that the new model that we have in place is beginning to pay dividends for us.

關於您的第二個問題，即我們在第二季度看到的額外作家，絕大多數新作家都不屬於 COE，考慮到我們在本季度看到了滲透率的良好上升，這是理所當然的。我再次認為這是一個很好的領先指標，表明我們實施的新模式開始為我們帶來回報。

Thanks, Tom. Do you want to ask your one on one question, Ritu?

謝謝，湯姆。你想一對一地問問題嗎，Ritu？

Yes, and just mopping up after Tess's questions. Can you talk to how the conduct specifically dropouts of the Phase 3 Prader-Willi have gone? Are they within expectations and all are the, are all the DSMB looks for the trial completed and if the SAP has been finalized with FDA.

是的，我只是在整理 Tess 的問題。您能談談普拉德-威利兒童行為測試第三階段的輟學者的情況嗎？它們是否符合預期？ DSMB 是否期待所有試驗都已完成？ SAP 是否已與 FDA 最終確定？

So I'm not going to comment on data from a currently ongoing trial aside from to say that generally speaking, we are continuing to see this trial unfolding in an acceptable way, but obviously it's blinded and I'm not going to comment any further on that at this point. We do have an SAP in place. I do consider that we have the right to continue to modify until before we unwind the trial, but we do have our planned analysis established at this point.

因此，我不會對目前正在進行的試驗的數據發表評論，除了說總體而言，我們繼續看到這項試驗以可接受的方式展開，但顯然它是盲目的，我現在不會對此發表進一步的評論。我們確實有一個 SAP。我確實認為我們有權在審判結束之前繼續修改，但我們此時已經建立了計劃分析。

Great. Thank you.

偉大的。謝謝。

Sean Laaman, Morgan Stanley.

摩根士丹利的肖恩拉曼。

Hi, this is Mike Riad on for Sean. Thank you for taking our questions and congratulations on the quarter. So thinking about DAYBUE, the 987 new patient ads, suggests a good steady growth rate quarter over quarter. How should we be thinking about this trajectory? Like, given the relative lower prevalence, is it reasonable to expect that this would ever accelerate and doesn't need to, or how should we just thinking about that trajectory? Thanks so much.

大家好，我是 Mike Riad，代表 Sean。感謝您回答我們的問題，並祝賀本季取得的成績。因此，考慮到 DAYBUE，987 個新患者廣告顯示季度環比成長率保持良好穩定。我們該如何思考這個軌跡？例如，考慮到相對較低的盛行率，是否有理由預期這種情況會加速但並不需要加速，或者我們應該如何思考這一軌跡？非常感謝。

So it's Tom here. I'll take that one. Thank you for the question. So we're pleased with the steady growth that we've seen over the last three quarters. I think, as we mentioned in the call, if you look at Q4, we had around 920 patients that increased to close to 954 in Q1, and we're pleased with the continued growth that we saw through Q2 with 987 active patients on therapy.

原來是湯姆在這裡。我要那個。謝謝你的提問。因此，我們對過去三個季度的穩定成長感到滿意。我認為，正如我們在電話會議中提到的那樣，如果您看一下第四季度，我們有大約 920 名患者，而第一季度則增加到接近 954 名，我們對第二季度持續增長感到滿意，目前有 987 名活躍患者正在接受治療。

Obviously, the plan that we have moving forward is that, that will continue to accelerate as we see the impact of our new customer model and our goal is to make sure that we have more new patient starts continuing week over week and month over month and quarter over quarter.

顯然，隨著我們看到新客戶模式的影響，我們未來的計畫將繼續加速，我們的目標是確保我們每週、每月、每季都有更多的新患者開始接受治療。

And I think now we have this very stable and growing group of persistent patients, many of whom have now been on treatment for 12 months or longer, I think gives us a real sense that we can really continue to grow this brand and take it to new heights.

我認為現在我們擁有一個非常穩定且不斷增長的持續患者群體，其中許多人已經接受治療 12 個月或更長時間，我認為這讓我們真正感覺到我們可以繼續發展這個品牌並將其推向新的高度。

Thanks so much.

非常感謝。

Jason Butler, Citizens JMP.

傑森‧巴特勒 (Jason Butler)，公民 JMP。

Hi, thanks for taking the questions. I just one on the plaza, given that you're seeing a return on investment on, for example, DTC activities, and now that you have the greater visibility with intellectual property, are there more investments or longer term investments that you're considering for the franchise? Thanks.

你好，謝謝你回答這些問題。我只是在廣場上問一個問題，鑑於您看到了例如 DTC 活動的投資回報，並且現在您在知識產權方面有了更大的知名度，您是否正在考慮對特許經營進行更多投資或長期投資？謝謝。

Hi, Jason, thanks for the question. I think as we think about our strategy, we need that, I try -- I encourage us to sort of bifurcate, the commercial strategy that we're putting in place now with the longer term ability to now maximize the brand.

你好，傑森，謝謝你的提問。我認為，當我們考慮我們的策略時，我們需要這樣做，我嘗試——我鼓勵我們將我們現在實施的商業策略與現在最大化品牌的長期能力進行區分。

So direct consumer decisions that we're making are sort of relative to the 2038 shorter term. We're seeing impact of the DTC. We would have continued to invest regardless of the outcome of the IP trial because it has a strong momentum for the next sort of two to three years potentially depending on how long we continue to invest. Beyond that now, what we have been able to do is think about the longer term strategy for NUPLAZID.

因此，我們所做的直接消費者決策在某種程度上是相對於 2038 年的短期而言的。我們看到了 DTC 的影響。無論知識產權審判的結果如何，我們都會繼續投資，因為它將在未來兩到三年內保持強勁勢頭，這可能取決於我們繼續投資多長時間。除此之外，我們現在能夠做的就是考慮 NUPLAZID 的長期策略。

I'm looking forward to sharing a little bit more about that as we head towards the back end of the year in terms of how we now think about the investment longer term, but for right now the DTC campaign is certainly paying dividends, as you point out, and we're excited about the continued momentum.

隨著我們即將進入年底，我期待著就我們現在如何看待長期投資分享更多相關信息，但就目前而言，正如您所指出的，DTC 活動肯定正在帶來回報，我們對持續的勢頭感到興奮。

And indeed in terms of the more to Parkinson's campaign and raising awareness of hallucinations and delusions, we're delighted that Ryan Reynolds has agreed to continue supporting that campaign. Because we believe that's been one of the main drivers of increased awareness, and once a caregiver is aware, they're encouraged to go in and talk to their doctor. So it's been a very strong impact to caregivers and we're excited to continue that. Thanks for the question.

事實上，就帕金森氏症防治運動以及提高人們對幻覺和妄想的認識而言，我們很高興瑞安雷諾茲同意繼續支持這項運動。因為我們相信這是提高意識的主要驅動力之一，一旦護理人員意識到這一點，我們就會鼓勵他們去看醫生並與之交談。因此，這對護理人員產生了非常強烈的影響，我們很高興能夠繼續這樣做。謝謝你的提問。

Thank you.

謝謝。

Brian Abrahams, RBC Capital Markets.

加拿大皇家銀行資本市場 (RBC Capital Markets) 的 Brian Abrahams。

Hey guys, congrats on the quarter. Thanks for taking my questions. Just two for me, I guess just both on DAYBUE. As you've expanded the Salesforce, can you talk a little bit more, I guess, qualitatively around your learnings from the patients outside of the centers of excellence.

嘿夥計們，恭喜本季。感謝您回答我的問題。對我來說只有兩個，我想 DAYBUE 上只有兩個。既然您已經擴展了 Salesforce，您能否更定性地談談您從卓越中心以外的患者那裡學到的知識。

Just in terms of physician receptivity, number of prescriptions per physicians, any early persistent signals and how well educated the docs are around the titration. And then can you also maybe talk about any hints of changes you may be seeing in overall DAYBUE persistence both quarter over quarter and bigger picture trends and just how much the education around AE management and the efficacy message and importance of staying on therapy is resonating. Thanks.

僅就醫生的接受度、每位醫生的處方數量、任何早期的持續信號以及醫生對滴定的了解程度而言。然後，您能否談談您在整體 DAYBUE 持久性方面可能看到的任何變化跡象，包括季度環比和更大的趨勢，以及圍繞 AE 管理的教育以及療效信息和堅持治療的重要性引起了多大的共鳴。謝謝。

Thanks, Brian. I'll let Tom come with his thoughts on that.

謝謝，布萊恩。我會讓湯姆來談談他對此的想法。

Yeah, thanks for the question. So yeah, we've already had a number of learnings as we've expanded beyond kind of the COEs. One of the key things is there is clearly receptivity to DAYBUE outside of the COEs. We know that there are physicians who are treating Rett patients who won't necessarily have been called on yet, and we're appreciating that.

是的，謝謝你的提問。是的，隨著我們不斷擴展 COE 的範圍，我們已經學到了很多。關鍵因素之一是，COE 之外的人們顯然對 DAYBUE 表現出了極大的接受度。我們知道，有些正在治療雷特氏症患者的醫生不一定會被叫去就診，我們對此表示感謝。

They require kind of ongoing education to make sure that they fully understand the profile of the product, they fully understand how to utilize the product, and we're utilizing the full mechanics of the system that we've built to make sure that we can educate all of those prescribers as quickly as possible.

他們需要持續的教育，以確保他們完全了解產品的概況，完全了解如何使用產品，並且我們正在利用我們構建的系統的完整機制，以確保我們能夠盡快教育所有開處方者。

So I think one thing that you probably need to be thinking about as you look at modeling is that the buying process, the number of calls may be slightly longer for this group of prescribers versus those that we see for COEs. And that's purely because they just don't see Rett patients as frequently.

因此，我認為，當您查看模型時，您可能需要考慮的一件事是，對於這群處方者來說，購買流程和呼叫次數可能比我們在 COE 中看到的要長一些。這純粹是因為他們不常見到雷特氏症患者。

As you talk about persistency, I mean, we're really pleased with the persistency that we're seeing. So as I mentioned on the call, 12 months persistency remains well above 50%, and as we also mentioned for the first time, our 18 month persistency, although not yet fully mature is above 45%.

正如您所說，持久性，我的意思是，我們對所看到的持久性感到非常高興。正如我在電話中提到的那樣，12 個月的持續性仍然遠高於 50%，而且正如我們第一次提到的那樣，我們的 18 個月的持續性雖然尚未完全成熟，但也高於 45%。

So I think that that gives us a real good sense that we have a -- we've kind of reached a nice kind of plateau as we go into the longer term outlook for the product. And that gives us with this growing group of patients who are now receiving therapy, a sense that we can continue to grow DAYBUE to new heights as I've mentioned, as we get new patients started.

所以我認為這讓我們真正感覺到，當我們展望產品的長期前景時，我們已經達到了一個很好的平台期。隨著現在接受治療的患者群體不斷擴大，我們感覺到，隨著新患者的開始治療，我們可以繼續將 DAYBUE 發展到新的高度，正如我所提到的。

Thanks, Tom. Thanks for the question, Brian.

謝謝，湯姆。謝謝你的提問，布萊恩。

Thanks a lot.

多謝。

Ami Fadia, Needham and Company.

Ami Fadia，Needham and Company。

Good evening. Thanks for taking my question. I have two quick ones. Firstly, just with regards to NUPLAZID, it continues to remain very strong with the number of ship bottles that you mentioned. Can you give us some sense of what's driving the strength and maybe give us some color around where the growth is coming from across channels?

晚安.感謝您回答我的問題。我有兩個簡短的。首先，就 NUPLAZID 而言，就您提到的運輸瓶數量而言，它仍然保持著非常強勁的勢頭。您能否向我們解釋一下推動這一成長的因素，並告訴我們成長來自哪些管道？

And then with regards to DAYBUE as you see increased adoption outside the series setting. Can you give us a sense of what you saw in your open level study in terms of persistency out at 12 or 18 months in -- with regards to patients that are being treated outside the COE study. If you have that. Thank you.

然後關於 DAYBUE，您會看到該系列設定之外的採用率有所增加。您能否向我們介紹一下您在開放程度研究中觀察到的 12 或 18 個月後的持續性情況——針對在 COE 研究之外接受治療的患者。如果你有的話。謝謝。

Ami, thanks. I'm going to let Tom answer both of those and Liz may be in terms of the longer term in the trial. But Tom?

阿米，謝謝。我會讓湯姆回答這兩個問題，而利茲可能會從審判的長期角度來回答。但是湯姆？

So in terms of NUPLAZID, yeah, I mean, we're seeing a nice uptick in terms of referrals NBRxs and the ongoing TRx volume. I think if you look at the second quarter and kind of the impact that we saw, we were pleased with the fact that -- we're pleased with the fact that our NBRx volume was kind of reflected across all channels, so we saw it both within the community setting, but we also saw nice increases across the LTC setting as well.

因此，就 NUPLAZID 而言，是的，我的意思是，我們看到推薦 NBRxs 和持續 TRx 量方面出現了良好的上升趨勢。我認為，如果你看一下第二季度以及我們看到的影響，我們很高興看到我們的 NBRx 量在所有管道中都有所反映，因此我們在社區環境中看到了它，但我們也看到了整個 LTC 環境中的良好增長。

As a reminder, the vast majority of patients do sit within the community setting, but the fact that we have a group of patients that sit within long-term care where we also promote showed kind of just continued strength across the breadth of patients that we serve for NUPLAZID. So very pleased with that kind of ongoing uptick and the strength that we have now going into the second half of the year.

提醒一下，絕大多數患者確實在社區環境中接受治療，但事實上，我們有一群患者接受長期護理，我們也在推廣這種護理，這在某種程度上表明我們為 NUPLAZID 服務的廣大患者群體具有持續的實力。我對這種持續上漲的勢頭以及我們進入下半年的強勁勢頭感到非常高興。

In terms of the question around DAYBUE and the real world data, I think the real world data that we have and we had a recent publication, I think at IRSF that showed that at 18 months we had about a 40% persistency rate.

關於 DAYBUE 和真實世界數據的問題，我認為我們擁有的真實世界數據和我們最近發表的一份出版物，我認為在 IRSF 上顯示，在 18 個月時我們的持續率約為 40%。

So I think the real world data that we're now seeing through the latest data with a 45% persistency rate through 18 months, I think really kind of begins to match up with that very, very nicely, and I think again, gives us a real sense that this drug is performing as we've seen in clinical studies and moving forwards, we don't expect to see any sign of kind of significant deviation versus this very kind of stable kind of plateau that we're now seeing.

因此，我認為我們現在透過最新數據看到的真實世界數據，即 18 個月的持續率為 45%，我認為這確實開始與此非常非常好地匹配，而且我再次認為，這讓我們真正感覺到這種藥物的表現正如我們在臨床研究中看到的那樣，並且在未來的發展中，我們預計不會看到任何與我們現在看到的這種非常穩定的平台相比出現非常穩定的平台。

And I'll just add on. Thanks, Tom. I'll just add on that, in our actual clinical trial experience, we really only have about nine months of data that you can kind of count on from a persistency perspective because in the later part of the open label extension we had patients going off to market a drug and so coming off of the program.

我再補充一下。謝謝，湯姆。我只想補充一點，在我們的實際臨床試驗經驗中，從持久性的角度來看，我們實際上只有大約九個月的數據可以依靠，因為在開放標籤擴展的後期，我們讓患者去推銷一種藥物，從而退出該計劃。

If you look to that nine month experience at that point, you've got something like 45% persistency. So I think what we continue to see and what we've seen sort of all along is that actually the real world persistency is a little bit better than we're seeing in the clinical trials.

如果你回顧當時的九個月的經歷，你會發現堅持率大約是 45%。所以我認為我們繼續看到的以及我們一直以來看到的是，現實世界的持久性實際上比我們在臨床試驗中看到的要好一些。

Thanks, Liz.

謝謝，莉茲。

Marc Goodman, Leerink.

馬克古德曼，Leerink。

Can you talk about discontinuations for DAYBUE and what you saw in the quarter and was there any inventory changes that were of any significance for either product? Thank you.

您能談談 DAYBUE 的停產情況以及您在本季看到的情況嗎？這兩種產品的庫存變化是否有任何重大變化？謝謝。

Thanks, Marc. I'll let Tom talk to that.

謝謝，馬克。我會讓湯姆談論這個。

Yeah, discontinuations, Marc. We were very pleased that we had another quarter where discontinuations remained well below 10%. Again, I think as you think about discontinuations as part of the overall story that we're now telling in terms of DAYBUE, very stable but growing group of active patients.

是的，停產，馬克。我們非常高興，本季的停產率仍遠低於 10%。再次，我認為當您將停藥視為我們現在就 DAYBUE 講述的整個故事的一部分時，活躍患者群體非常穩定但不斷增長。

Discontinuations remaining relatively low, and I think that this all speaks to the fact that we really now have a very good understanding as to the profile of the product, how we can engage with the patient community, and ensuring that as we move forward again with a real focus on the efficacy profile of the product, which continues to be strengthened, thanks to the work of Liz and team that, we feel very good about the direction of travel for DAYBUE as a whole. I'll ask Mark to answer the --

停藥率仍然相對較低，我認為這一切都說明我們現在對產品概況、如何與患者群體互動有了很好的了解，並確保隨著我們再次向前發展，真正關注產品的功效概況，由於 Liz 和團隊的努力，產品的功效概況不斷得到加強，我們對 DAYBUE 整體的發展方向感到非常滿意。我會請馬克回答--

Yeah. Thanks for the question. Yeah, there's nothing to report on in channel inventory, NUPLAZID consistent quarter over quarter, and then just as a reminder that concept really doesn't exist for DAYBUE as our single specialty pharmacy really only takes control of the inventory for like a nanosecond before it goes directly to patients. So the DAYBUE model has always been really a sell through model.

是的。謝謝你的提問。是的，通路庫存沒有什麼可報告的，NUPLAZID 季度與季度之間保持一致，然後提醒一下，這個概念對於 DAYBUE 來說實際上並不存在，因為我們的單一專業藥房實際上只在庫存直接送到患者手中之前的一納秒內控制庫存。因此，DAYBUE 型號一直是暢銷型號。

Fair enough. Mark, can you also just -- Mark, can you also comment on just the tax rate and how to think about it this year and going forward?

很公平。馬克，你能否——馬克，你能否就稅率以及今年和未來如何考慮稅率發表評論？

Yeah. So our tax -- so right, I guess if you look at our P&L, our book tax rate year over year is a little higher because for GAAP accounting we're not able to account for all the credits and NOLs that we're actually using for modeling purposes, our cash tax rate remains currently.

是的。所以我們的稅收 - 是的，我想如果你看一下我們的損益表，我們的賬面稅率同比要高一點，因為對於 GAAP 會計，我們無法計算我們實際用於建模目的的所有信用和 NOL，我們的現金稅率目前保持不變。

In kind of the mid-teens rate, long term we guide more towards mid-20s and that's before considering anything for OB3 which will start to be implemented from our standpoint in the next quarter. And with that we have about $400 million of kind of US based activity R&D expense that had been capitalized and that in the near term, we'll be able to have some accelerating extending for US tax purposes. So in the next year or two our tax rate will actually go down.

就十幾歲的中段利率而言，長期來看，我們預計利率將更接近二十五、六歲，這還沒有考慮 OB3 的任何內容，從我們的角度來看，OB3 將於下個季度開始實施。這樣，我們就有大約 4 億美元的美國活動研發費用已經資本化，並且在短期內，我們將能夠出於美國稅收目的而加速延長。因此，在未來一兩年內，我們的稅率實際上會下降。

OB3 is our internal vernacular for One Big Beautiful Bill just in case. Thanks, Mark. Next question.

OB3 是我們內部對「One Big Beautiful Bill」的稱呼，以防萬一。謝謝，馬克。下一個問題。

Ash Verma, UBS.

瑞銀的 Ash Verma。

Yeah, hi, thanks for taking our questions. So for NUPLAZID, I know like you've outlined that this is a largely Medicare patient population, roughly by when do you think that it'll be eligible for IRA price negotiation and implementation?

是的，嗨，感謝您回答我們的問題。那麼對於 NUPLAZID，我知道您已經概述過，這主要是醫療保險患者群體，您認為它大約什麼時候才有資格進行 IRA 價格談判和實施？

And then secondly, on the ACP-101, I wanted to ask like, is this the same formulation from setting that required refrigeration and do you think that could potentially become a hindrance at all, in terms of price daily administration for this patient population and then is there a plan for a room temperature stable radiant here? Thanks.

其次，關於 ACP-101，我想問的是，這是否與需要冷藏的配方相同，您是否認為這可能會成為任何障礙，對於該患者群體的日常管理價格而言，然後是否有針對室溫穩定輻射的計劃？謝謝。

Thanks, Ash. I'm going to let Mark answer the IRA question and then Liz on 101, and some of that was a little bit unclear. You broke up for a little bit, so you might have to just say a 101 question again for Liz, so she can make sure she answered it correctly. But let's start with the IRA.

謝謝，阿什。我會讓馬克回答 IRA 問題，然後讓利茲回答 101 問題，其中一些問題有點不清楚。你們分手了一會兒，所以你可能不得不再問 Liz 一個 101 個問題，這樣她才能確保她回答正確。讓我們先從愛爾蘭共和軍開始。

Yeah. In terms of potential timing for negotiation under the IRA, 2029 would be the first year that NUPLAZID is eligible for negotiation unless there's changes in the legislation like getting rid of the pill penalty, that's probably the year we anticipate we'd potentially be subject to negotiation.

是的。就 IRA 下談判的潛在時間而言，2029 年將是 NUPLAZID 有資格進行談判的第一年，除非立法發生變化，例如取消藥丸懲罰，這可能是我們預計我們可能接受談判的一年。

Just to remind you as a small company, we'd have a limit on the discount we'd have to offer. It's in the range of 25% to 34% as outlined in the legislation. And then after that would be subject to negotiation like any other drug. From our standpoint, just due to the launch timing of NUPLAZID, if the pill penalty is removed that could add another year before negotiation, would likely be expected.

只是提醒您，作為一家小公司，我們提供的折扣是有限制的。根據立法規定，該比例在 25% 至 34% 之間。然後，這將像任何其他藥物一樣接受談判。從我們的角度來看，僅由於 NUPLAZID 的推出時間，如果取消藥丸懲罰，談判時間可能會延長一年，這是可以預料的。

Right. And the small company is the two year.

正確的。而小公司則是兩年。

Two year, yes.

是的，兩年。

Yeah, right.

是的，沒錯。

And with respect to ACP-101 and the questionnaire and that obviously tell me if there's anything that I didn't catch about your question that I neglect here. But we are using the same formulation as Levo used and an important thing to remember is that part of what we're doing here is a resubmission to the complete response letter, and so the intent is to provide the new information that FDA requires, which is an additional study to demonstrate efficacy while changing a few things as possible about the overall initial presentation.

關於 ACP-101 和問卷，請告訴我關於您的問題我是否還有什麼我沒有註意到或忽略的地方。但我們使用的配方與 Levo 相同，需要記住的一件重要事情是，我們在這裡所做的部分工作是重新提交完整的回复信，因此目的是提供 FDA 要求的新信息，這是一項額外的研究，以證明其功效，同時盡可能改變整體初始陳述的一些內容。

We have seen that to be acceptable and usable in our clinical trials, have not found it to be a concern in terms of your question about next generation, we're always considering whether there are things that we can do to our products to make them more patient friendly. And so I anticipate that we'll be thinking about that for 101 as well as we do for other things.

我們已經看到它在我們的臨床試驗中是可以接受和可用的，就您關於下一代產品的問題而言，我們並沒有發現它會帶來什麼問題，我們一直在考慮是否可以對我們的產品做一些事情，使它們更加適合患者。因此我預計我們會像考慮其他事情一樣考慮 101 的問題。

Fantastic.

極好的。

David Hoang, Deutsche Bank.

德意志銀行的 David Hoang。

Hi there, congrats on the quarter and thanks for taking my question. I just want to ask on ACP-101, can you, comment or say anything on the -- I guess open label extension for the Phase 3 study like, what you're seeing in terms of rollover rate.

您好，恭喜本季取得佳績，感謝您回答我的問題。我只是想問一下關於 ACP-101 的問題，您能否對第三階段研究的開放標籤擴展發表評論或發表任何意見，例如您在滾動率方面看到的情況。

And would you ever consider adding a randomized withdrawal portion to the plan that I think was used by a competitor with approved products in the market to get that product approved. Thank you.

您是否考慮過在計劃中添加隨機提款部分，我認為該計劃已被市場上已批准產品的競爭對手用來獲得該產品的批准。謝謝。

Great questions. So first off, on the OLE, I'm not going to comment too specifically at this point, but I will say that we have seen generally good interest in our open label extension and are continuing to collect information on patients who are enrolling into that.

很好的問題。首先，關於 OLE，我現在不會發表太具體的評論，但我要說的是，我們看到大家對我們的開放標籤擴展普遍很感興趣，並且我們正在繼續收集有關參與其中的患者的信息。

So the question about the randomized withdrawal, it's an interesting question, at this point we really are focused on the results of our current parallel arm study that we're looking at those data coming in early Q4, and we think a really an advantage of that, is that's going to be able to give a clear if it's positive and it turns out the way we hope it's going to give a clear demonstration for regulators for physicians, and for patients and families of what you could expect upon initiation of therapy.

因此，關於隨機退出的問題是一個有趣的問題，目前我們真正關注的是當前平行組研究的結果，我們正在研究第四季度初的數據，我們認為這樣做的一個真正優勢是，如果結果是積極的，它將能夠清楚地表明結果，我們希望它能夠為監管機構、醫生、患者和家屬清楚地展示開始治療後可以期待什麼。

A randomized withdrawal study could be something that we might consider in the future, but at this point we think the most important data set really is this parallel group study that we're currently running and eagerly anticipating the data.

我們將來可能會考慮進行隨機撤藥研究，但目前我們認為最重要的數據集實際上是我們目前正在進行並熱切期待數據的平行組研究。

Thanks, David.

謝謝，大衛。

Uy Ear, Mizuho.

烏伊·厄爾，瑞穗。

Hi, thanks for taking our questions. This is Leo on for Uy, and congrats on the quarter. For each of your brand's NUPLAZID and DAYBUE, what is the right way for us to be thinking about 2026 from a growth perspective? What are the key factors and drivers we should be thinking about? Maybe on the heels of the recent R&D Day excitement's clearly growing in the pipeline, which pipeline programs is the team most excited about? Thanks.

您好，感謝您回答我們的問題。我是 Leo，代表 Uy，恭喜本季取得的成績。對於你們旗下的NUPLAZID和DAYBUE品牌，我們該如何從成長的角度來思考2026年呢？我們應該考慮哪些關鍵因素和驅動因素？也許在最近的研發日活動之後，人們對管道的興奮感明顯增長，團隊對哪些管道項目最為興奮？謝謝。

Thanks, Leo. I'm going to ask Tom to comment on how to think about growth in '26 (inaudible) brands, and then Liz to tell us which is her favorite child in her pipeline.

謝謝，Leo。我將請湯姆評論如何看待 26 個（聽不清楚）品牌的成長，然後請莉茲告訴我們她最喜歡她的產品線中的哪個品牌。

Yeah, thanks for the question. So let me start with DAYBUE. So as we've mentioned during the call, we've seen very nice, continued growth for the last three quarters in terms of active patients. We do anticipate through the second half of the year that the rate that we are growing that number will accelerate as we see the impacts of our new field force model really begin to pull through.

是的，謝謝你的提問。那麼就讓我從 DAYBUE 開始吧。正如我們在電話會議中提到的那樣，我們看到過去三個季度活躍患者的數量持續保持良好成長。我們確實預計，到今年下半年，隨著我們新的現場人員模式的影響真正開始顯現，這一數字的成長速度將會加快。

As a reminder, our penetration rate in general across the entire Rett community remains kind of in the low 30%. So we've still got a significant opportunity here for this brand to continue to grow, and that's our goal through 2026 and beyond is to really make sure that we engage with the right patient community in the right way.

提醒一下，我們在整個 Rett 社群的滲透率總體上仍然在 30% 以下。因此，我們仍然有很大機會讓這個品牌繼續發展，而我們到 2026 年及以後的目標是確保我們以正確的方式與正確的患者群體互動。

We really meet patients where they are, which is what we are doing with our new customer model. And we can really make sure that we take DAYBUE to the height that we know it can be. So that's our goal for '26. So it's really a story of continued, and we plan for accelerating growth through the year.

我們確實在患者所在的地方與他們見面，這就是我們新客戶模式所做的事情。我們可以真正確保 DAYBUE 達到我們所知的高度。這就是我們 26 年的目標。所以這實際上是一個持續的故事，我們計劃在今年加速成長。

As it relates to NUPLAZID. It's a similar story in a way, I think we've seen this year and this quarter in particular some very nice numbers in terms of leading metrics. The team in the field continue to execute very well.

因為它與 NUPLAZID 相關。從某種程度上來說，這是一個類似的故事，我認為我們今年，特別是本季度，在領先指標方面看到了一些非常好的數字。該團隊在現場的表現繼續非常出色。

Our campaigns are working for us very well and are giving us a nice tailwind as we think about the second half of this year, and we believe that sets us very nicely up for 2026. So I think the outlook for both brands from a commercial point of view is one of strength, and we really look forward to really capitalizing on that as we head into 2026.

我們的活動進展順利，為我們展望今年下半年提供了良好的推動力，我們相信這將為我們在 2026 年取得圓滿成功奠定基礎。因此，我認為從商業角度來看，這兩個品牌的前景都很強勁，我們非常期待在邁向 2026 年時真正利用這一點。

I love that Catherine teed this up as my favorite child because what I was going to say is I would never say who my favorite child is, I think that across our pipeline we have a nice mix of assets that are relatively de-risked from a mechanistic perspective, things like ACP-204, where we are following in learnings that we have from NUPLAZID, as well as some areas of really novel biology like ACP-271.

我很高興凱瑟琳將其列為我最喜歡的孩子，因為我要說的是，我永遠不會說出我最喜歡的孩子是誰，我認為在我們的整個管道中，我們擁有從機械角度來看相對低風險的資產組合，例如 ACP-204，我們正在遵循從 NUPLAZID 獲得的經驗，以及一些真正新穎的生物學領域，例如 ACP-271。

I think that we are excited about the fact that we've got a number of different ways we could potentially serve patients living with rare neurological diseases. So there's a lot in our pipeline that we're very enthused about, and I'm not going to pick a favorite child today.

我認為，我們很高興能夠透過多種不同的方式為患有罕見神經系統疾病的患者提供服務。因此，我們對很多項目都非常熱衷，今天我不會挑選一個我們最喜歡的項目。

Maybe I'll just come on top of that with, I think what was exciting for us at R&D Day was to be able to share. Our expectations on the market opportunity that these brands, these new brands potentially disapproved offer to ACADIA in terms of potential expansion.

也許我只是想說，我認為研發日讓我們興奮的事情就是能夠分享。我們對這些品牌、這些新品牌在潛在擴張方面可能為 ACADIA 帶來的市場機會的預期。

And we shared at R&D day that we believe all five of the new products could hit blockbuster potential, and we believe three of them have the ability to achieve over $2 billion should they be successfully approved. So we're moving into bigger markets with still high on that medical need.

我們在研發日上表示，我們相信所有五種新產品都可能產生巨大的潛力，我們相信其中三種產品如果成功獲得批准，其銷售額將超過 20 億美元。因此，我們正在進入更大的市場，但醫療需求仍然很高。

And we're excited to continue to focus our development on really differentiated assets and ensuring that we're developing a pipeline of valuable innovation that patients from those underserved communities will really feel adds to their opportunity to see more memorable moments with their families. So we're excited for that.

我們很高興能夠繼續將我們的開發重點放在真正差異化的資產上，並確保我們正在開發一系列有價值的創新，讓來自服務不足社區的患者真正感受到增加了他們與家人共度更多難忘時光的機會。所以我們對此感到很興奮。

Awesome. Thanks.

驚人的。謝謝。

Tazeen Ahmad, Bank of America.

美國銀行的塔津·艾哈邁德（Tazeen Ahmad）。

Hi, good afternoon. Thanks for taking my question. I wanted to ask about whether the 204 study in Lewy Body Dementia has started. I think your guidance has been that it's supposed to start soon or this quarter. And then I also wanted to get your thoughts about the ADP data that's expected in the middle of next year.

嗨，下午好。感謝您回答我的問題。我想問一下路易氏體失智症的204項研究是否已經開始了。我認為您的指導是它應該很快或本季開始。然後，我也想了解您對預計明年年中發布的 ADP 數據的看法。

If that's positive, what's your view about the likelihood of the Lewy Body study working, knowing that you had -- the company had looked at Lewy Body as part of a previous study with pima a few years ago. Thanks.

如果這是正面的，那麼您對路易氏體研究成功的可能性有何看法？據您所知，該公司幾年前在對皮馬山羊的研究中曾對路易體進行研究。謝謝。

Okay. The first easy one, which is we do continue to anticipate that the Lewy Body study will get started this quarter. So hasn't gotten first patient randomized yet, but we are confident we'll get it in the quarter. In terms of ADP and potential for read through, I guess what I'll say is that, I think that the data, while limited in terms of its numbers that we have from NUPLAZID is pretty supportive of Lewy Body.

好的。第一個簡單的問題是，我們確實繼續預期路易氏體研究將於本季開始。因此，我們尚未對第一位患者進行隨機分組，但我們相信我們將在本季度完成分組。就 ADP 和閱讀潛力而言，我想我要說的是，我認為，雖然我們從 NUPLAZID 獲得的數據數量有限，但這些數據非常支持路易體。

Again, there's relatively small number of patients in that study, but roughly 20 patients in the active arm and 20 patients in the placebo arm, and there was a marked difference in relapse rate of patients on placebo versus patients who continued on drugs.

同樣，研究中的患者數量相對較少，但活性藥物組約有 20 名患者，安慰劑組約有 20 名患者，服用安慰劑的患者與繼續服用藥物的患者的復發率有顯著差異。

So I think we have some good reason to believe just based on the existing NUPLAZID data set. A positive ADP days said is certainly going to make me feel better, in particular because that gives you clear evidence that this particular molecule is active, though we of course expect it to be based on all the non-clinical and Phase 1 works that we've done to date. So certainly we are anticipating that ADP readout with a great deal of anticipation and feel good about Lewy Body and its potential for success.

因此我認為，僅基於現有的 NUPLAZID 資料集，我們就有充分的理由相信。ADP 的積極進展肯定會讓我感覺更好，特別是因為它為您提供了明確的證據，證明這種特定分子具有活性，儘管我們當然希望它基於我們迄今為止所做的所有非臨床和第一階段工作。因此，我們當然對 ADP 讀數充滿期待，並對路易氏體及其成功潛力充滿信心。

Thanks, Liz. Thanks, Tazeen.

謝謝，莉茲。謝謝，Tazeen。

Sumant Kulkarni, Canaccord.

Sumant Kulkarni，Canaccord。

Good afternoon. Nice to see the progress this quarter and thanks for taking our questions. Could you give us some specifics on how ACP-2591 fits into your plans for Rett syndrome relative to your current efforts with DAYBUE?

午安.很高興看到本季的進展，並感謝您回答我們的問題。您能否具體說明 ACP-2591 如何融入您的雷特氏症治療計畫以及您目前在 DAYBUE 的努力？

Thanks for the question. We haven't had a 2591 question for a while. So, I'll let Liz answer that.

謝謝你的提問。我們已經有一段時間沒有遇到 2591 個問題了。所以，我讓 Liz 來回答這個問題。

Yeah. Excuse me, as we think about ACP-2591, I mean, I think what originally attracted us to the program was the fact that there are some similarities mechanistically speaking to DAYBUE, and so that de-risks it with a potential for a differential penetration from a brain perspective. So there's a possibility that you've got a difference on the benefit risk profile there.

是的。對不起，當我們考慮 ACP-2591 時，我的意思是，我認為最初吸引我們參與該計劃的原因是，從機制上講，它與 DAYBUE 有一些相似之處，因此從大腦的角度來看，這降低了它具有差異滲透的潛力的風險。因此，您的收益風險狀況可能會有所不同。

Obviously that's going to have to play its way out in Rett patients in order to know how that would -- how we would use that in the context of DAYBUE. What we're doing right now on this one is some additional work to verify how the information we need to specifically take forward in Rett, and I look forward to providing some additional updates on that at an appropriate time.

顯然，我們必須在 Rett 患者身上進行實驗才能知道在 DAYBUE 的背景下如何使用它。我們目前正在做的是一些額外的工作來驗證我們需要如何在 Rett 中具體推進的信息，我期待在適當的時候提供一些額外的更新。

Thanks.

謝謝。

Salveen Richter, Goldman Sachs.

薩爾文·里克特，高盛。

Good afternoon, thanks for taking my question. For PWS here beyond HQCT and CGIS and CGIC, do you plan to evaluate functional endpoints such as hyperglycemia control and weight loss in the Phase 3 trial and what would be a clinically meaningful bar for success in this study? Thank you.

下午好，感謝您回答我的問題。對於 PWS，除了 HQCT、CGIS 和 CGI​​C 之外，您是否計劃在 3 期試驗中評估高血糖控制和體重減輕等功能終點，以及本研究中成功的臨床意義標準是什麼？謝謝。

So in terms of clinically meaningful bar of success, I'll be very pleased if what I see out of this study is similar to the magnitude that was demonstrated with the 3.2 milligram dose in the prior study. That would be, I think we feel confident that that's going to be a meaningful change, and we feel confident not just from ourselves but from talking to physicians as well as patient advocacy organizations.

因此，就臨床意義上的成功標準而言，如果這項研究的結果與先前的研究中 3.2 毫克劑量所顯示的結果相似，我會非常高興。我認為我們有信心這將是一個有意義的改變，我們不只是對自己有信心，而且透過與醫生以及患者權益組織的交談充滿信心。

We think that, that would be a meaningful note. I mean, I will say that the -- I think your other question was about things like weight circumference. We aren't specifically looking at that. We do think that this is a complex interplay of the disease itself, as well as the mechanisms that families have put in place to manage their children and their access to food, so that hasn't been a focus here.

我們認為，這將是一個有意義的註釋。我的意思是，我想說——我認為你的另一個問題是關於體重週長之類的事情。我們並沒有特別關注這一點。我們確實認為這是疾病本身與家庭為管理孩子和獲取食物而建立的機制之間的複雜相互作用，因此這並不是這裡的重點。

We are looking at adverse events and typically at blood profiles and at least based on the data that we saw in the prior study, we have no reason to anticipate that routine monitoring is going to be necessary. That's going to be subject to the data we see in this study, of course.

我們正在研究不良事件，通常也研究血液狀況，至少根據我們在先前的研究中看到的數據，我們沒有理由預期需要進行常規監測。當然，這取決於我們在本研究中看到的數據。

Thanks, Salveen.

謝謝，薩爾文。

Yatin Suneja, Guggenheim.

古根漢美術館的亞廷·蘇內賈（Yatin Suneja）。

Hey, guys. Thank you for taking my question. Question is on 204 -- ACP-204. Could you just comment on the pharmacology that you think is better addressed with this molecule which was not addressed with the NUPLAZID specifically as it relates to this ADP population? Just trying to get a sense in terms of how the setup is or how different the set-up is into this ADP readout versus the DRP study that you ran with the NUPLAZID. Thank you.

嘿，大家好。感謝您回答我的問題。問題是關於 204 -- ACP-204。您能否評論一下您認為用這種分子可以更好地解決的藥理學問題，而 NUPLAZID 並沒有專門解決與 ADP 人群相關的問題？只是想了解設定情況如何，或者這個 ADP 讀數的設定與您使用 NUPLAZID 運行的 DRP 研究的設定有何不同。謝謝。

So I think -- so thank you for the question. As I think about the differences with 204, they kind of go into a couple of different categories. There's the molecule differences and then there's program design differences, and I do think both of those play into what we could be looking at the ADP study.

所以我認為——謝謝你的提問。當我思考與 204 的差異時，我發現它們可以分成幾個不同的類別。有分子差異，也有程式設計差異，我確實認為這兩者都會影響我們在 ADP 研究中看到的內容。

So on a molecule perspective, just hitting in on this really briefly, a NUPLAZID does have that QT prolongation. It's not significant. It's not clinically impactful, but in an elderly and frail patient population, you do need to think about it.

因此，從分子角度來看，只需簡單介紹一下，NUPLAZID 確實具有 QT 延長作用。這並不重要。這在臨床上沒有影響，但對於老年和體弱的患者群體來說，你確實需要考慮這一點。

But also it limits our ability to dose range and we do see some differences in the exposure response that suggest that higher levels of exposure could get us to higher efficacy. We think that this is a reason to think that we've got increasing reason to believe was 204 in our ADP program.

但它也限制了我們的劑量範圍，我們確實看到了暴露反應的一些差異，這表明更高水平的暴露可以使我們獲得更高的功效。我們認為，我們有越來越多的理由相信我們的 ADP 計劃中存在 204 個這樣的數字。

And then on the design of the program itself, I think one of the biggest things that we learned from our prior experience was the importance of having our program specifically focused on the disease that we are studying.

然後關於專案本身的設計，我認為我們從以前的經驗中學到的最重要的事情之一就是讓我們的專案專注於我們正在研究的疾病的重要性。

I don't want to go through the whole history of DRP, but obviously that was one of the challenges that we had there. So the program that we've designed with ADP is very specifically identified that patient population, it's specifically looking at a patient population that's a little more severe in their psychosis, which we also found to be more responsive, and we're biomarker confirming that patient population.

我不想回顧 DRP 的整個歷史，但顯然這是我們面臨的挑戰之一。因此，我們與 ADP 合作設計的程序非常明確地識別了患者群體，它專門針對精神病症狀更嚴重的患者群體，我們也發現這些患者群體反應更靈敏，並且我們正在透過生物標記確認該患者群體。

So if we take all of these things together, we think that we have set up, we think we have a good setup for ACP-204 to show what it can do and some good reasons to think that it might be more likely to be successful.

因此，如果我們把所有這些因素綜合起來，我們認為我們已經做好了準備，我們認為我們已經為 ACP-204 做好了良好的準備來展示它能做什麼，並且有一些很好的理由認為它更有可能成功。

Thanks, Yatin.

謝謝，亞汀。

Evan Seigerman, BMO Capital.

埃文·西格曼（Evan Seigerman），BMO Capital。

Hi, Malcolm Hoffman on for Evan. Thanks for taking our question. Back to DAYBUE, I noticed an improvement in the percent of active patients who have been on therapy for 12 months or longer from 65% to 70% this quarter.

大家好，馬爾科姆·霍夫曼代替艾文上場。感謝您回答我們的問題。回到 DAYBUE，我注意到本季接受治療 12 個月或更長時間的活躍患者比例有所提高，從 65% 上升到 70%。

Can you just expand on this a little bit further? Is this more a factor again of just providers handling treatment, becoming more comfortable with the GI profile, and how to manage it over time? Just would appreciate any color there. Thanks.

能進一步詳細說明一下嗎？這是否更多的是提供者處理治療、對 GI 概況更加滿意以及如何隨著時間的推移進行管理的一個因素？只是會欣賞那裡的任何顏色。謝謝。

Yeah, I'll say that question. So thank you. I think it's a few different factors. I mean -- as I mentioned a few minutes ago, we are learning more about the product as we go. We are clearly educating the both the patient community and the caregivers and the HCPs regarding, how they should go about utilizing the product.

是的，我會問這個問題。所以謝謝你。我認為有幾個不同的因素。我的意思是——正如我幾分鐘前提到的，我們正在逐步了解產品的更多資訊。我們正在明確教育患者群體、照護者和 HCP 如何使用該產品。

If you look at the overall kind of usage that we see, I mean, our percentage to dose remains in the 70% range, which I think also just talks to the fact that our user base is just getting more comfortable in terms of titration as well.

如果你看一下我們看到的整體使用情況，我的意思是，我們的劑量百分比保持在 70% 的範圍內，我認為這也說明了我們的用戶群在滴定方面也變得更加舒適。

And I think over time as they see the benefits of the product and as we lean in more on terms of the efficacy profile, I think that there is more that we can kind of pull through there as we think about kind of DAYBUE for the long term. So I think it's a story of continued knowledge.

我認為，隨著時間的推移，他們會逐漸看到產品的好處，我們也會更加重視功效概況，當我們考慮 DAYBUE 的長期發展時，我認為我們可以取得更大的進步。所以我認為這是一個關於持續知識的故事。

I think we continue to educate in the right way. We make sure that all of the learnings that we have from our COEs are now being amplified into the community as well, and I think that this is all being reinforced with our kind of updated customer model and strategy as we think about DAYBUE moving forwards.

我認為我們繼續以正確的方式進行教育。我們確保從 COE 獲得的所有經驗現在都能在社區中得到推廣，而且我認為，在我們考慮 DAYBUE 向前發展時，這一切都會透過我們更新的客戶模型和策略得到強化。

And I think just finally that the persistency that we continue to see sort of amplifies that. So the [65% to 70%] is really a recognition of everything that Tom has just talked to, just a much more stable base than we were a quarter ago and then we were a year ago. So again, lots of steadiness and now we're driving the momentum into DAYBUE. Thank you for the question.

我認為，最終我們繼續看到的持久性會放大這一點。因此，[65% 到 70%] 實際上是對湯姆剛才談到的一切的認可，與一個季度前和一年前相比，這是一個更加穩定的基礎。因此，再次強調，我們非常穩定，現在我們正將這一勢頭帶入 DAYBUE。謝謝你的提問。

Appreciate it. Thanks guys.

非常感謝。謝謝大家。

Paul Matteis, Stifel.

保羅‧馬泰斯 (Paul Matteis)，Stifel。

Hey there, this is Julian on for Paul. Thanks so much for taking our question and congrats on the progress. Just wanted to circle back to something that was, mentioned earlier in the Q&A about the SAP for SAP for ACP-101 and the how you guys quote unquote retain the right to modify the SAP while you remain blinded. Just curious what types of modifications could potentially qualify or could be sort of, in the realm of possibilities just curious if you could expand on that and I have one quick follow up as well on DAYBUE.

大家好，我是 Julian，代替 Paul。非常感謝您回答我們的問題，並祝賀取得的進展。我只是想回到之前在問答中提到的關於 ACP-101 的 SAP 的問題，以及你們如何在保持盲目性的同時保留修改 SAP 的權利。我只是好奇，在可能性的範圍內，哪些類型的修改可能符合條件或可能符合條件，只是好奇您是否可以詳細說明這一點，並且我對 DAYBUE 也有一個快速的跟進。

Yeah. No planned modifications. I purely meant that as a just a from a practical point of view until you have unblinded your database you can consider your SAP subject to the possibility to change, but no, there are no planned modifications.

是的。沒有計劃修改。我純粹是想從實際角度來說，直到您揭開資料庫的神秘面紗之前，您可以考慮讓 SAP 發生改變，但是沒有，目前還沒有計劃進行修改。

Got it. That's helpful. Thank you for clarifying. And then on DAYBUE, it just sounds like, things are going well. You're starting to see increased scripts in the community in addition to higher persistence or I guess, greater line of sight to the persistence of your patient population.

知道了。這很有幫助。感謝您的澄清。然後在 DAYBUE 上，聽起來事情進展順利。除了更高的持久性之外，你還開始看到社區中腳本的增加，或者我猜，對患者群體持久性的更大視線。

I guess you're just thinking about the second half of the year you've sort of messaged how, you expect to see greater growth, why the decision to not narrow guidance, this quarter it just seems like, you kind of easily hit if you continue to. Add the patience that you have this year. I'm just curious if that's being conservative, out of -- sake for being conservative or if there's anything else to that. Thank you.

我想你只是在考慮下半年的情況，你已經表達了你希望看到更大增長的原因，為什麼決定不縮小指導範圍，這個季度看起來，如果你繼續這樣做，你很容易就會受到打擊。加上你今年所擁有的耐心。我只是好奇這是否是保守的，出於保守的目的，或者有其他原因。謝謝。

Yeah. I wouldn't read anything in the guidance. I think what I would say maybe on the reason why we adjust a new closet is we started the year, with a large, a wider range than we normally do kind of coming into the year, not knowing all the puts and takes for the Medicare Part D redesign.

是的。我不會閱讀指南中的任何內容。我想說，我們調整新衣櫃的原因是，我們年初的範圍比往年更大、更廣，因為我們不知道醫療保險 D 部分重新設計的所有利弊。

So when we looked at the NUPLAZID range, we just thought it was just too wide kind of halfway through the year as we looked at all the other ranges we left them, including DAYBUE, and we'll revisit those in the third quarter as we would typically it would be a typical point to start narrowing.

因此，當我們查看 NUPLAZID 系列時，我們認為它在年中範圍太廣了，因為我們查看了我們留下的所有其他系列，包括 DAYBUE，我們將在第三季度重新審視這些系列，因為通常這將是開始縮小範圍的典型點。

Thanks everybody for the questions and thank you operator. We really appreciate everybody joining us today and we look forward to updating you on our progress next quarter.

感謝大家的提問，也感謝接線生。我們非常感謝大家今天加入我們，我們期待下個季度向你們通報我們的進展。

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

感謝大家參加今天的會議。該計劃確實就此結束。您現在可以斷開連線。