Acadia Pharmaceuticals Inc. (ACAD) 2026 Q1 法說會逐字稿

Ladies and gentlemen, thank you for standing by. My name is Krista, and I will be your conference operator today. At this time, I would like to welcome everyone to ACADIA Pharmaceuticals first-quarter 2026 earnings conference call. (Operator Instructions)

各位女士、先生，感謝您稍候。我是 Krista，今天將擔任本次電話會議的接線員。此刻，我謹代表主辦方歡迎各位參加 ACADIA Pharmaceuticals 2026 年第一季財報電話會議。(接線員指示)

Thank you. I would now like to turn the conference over to Albert Kildani, Senior Vice President, Investor Relations and Corporate Development. Please go ahead.

謝謝。現在我想將電話會議交給投資人關係與企業發展資深副總裁 Albert Kildani。請開始。

Good afternoon, and thank you for joining us on today's call to discuss ACADIA's first-quarter 2026 financial results.

各位下午好，感謝各位參加今天的電話會議，一同討論 ACADIA 2026 年第一季財務結果。

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. Also joining us today are Elizabeth Thompson, Ph.D., 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.

今天與我一同出席電話會議的 ACADIA 團隊成員包括：我們的執行長 Catherine Owen Adams，她將先做開場致詞；接著由我們的商務長 Tom Garner，說明我們的商業品牌 DAYBUE 與 NUPLAZID。此外，研發負責人、執行副總裁 Elizabeth Thompson 博士將提供研發管線計畫的最新進展；財務長 Mark Schneyer 則將回顧財務重點。

Katherine will then provide some closing remarks before we open up the call for your questions. We are using supplemental slides, which are available on our website in the Events and Presentations section. On today's call, both GAAP and non-GAAP financial measures will be discussed, including non-GAAP NUPLAZID net sales and non-GAAP total revenues.

之後 Katherine 將做結語，接著我們將開放提問。我們將使用補充簡報投影片，已公布於公司網站「活動與簡報（Events and Presentations）」專區。今天的電話會議將同時討論 GAAP 與非 GAAP 財務衡量指標，包括非 GAAP 的 NUPLAZID 淨銷售額與非 GAAP 的總營收。

The non-GAAP financial measures that are also referred to as adjusted financial measures pertain only to NUPLAZID sales in 2025 and their impact on total revenues. All references to non-GAAP are reconciled with the most directly comparable GAAP financial measures in our earnings press release and slide presentation, which has been posted on the investors page of the company's website.

這些非 GAAP 財務衡量指標（亦稱調整後財務衡量指標）僅與 2025 年 NUPLAZID 銷售及其對總營收的影響相關。所有非 GAAP 指標均已在我們的財報新聞稿與投影片簡報中，與最直接可比的 GAAP 財務衡量指標進行調節對照；相關資料已張貼於公司網站投資人專區。

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. These forward-looking statements, including goals, expectations, plans, prospects, growth potential, timing of events, future results and 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.

在繼續之前，我想提醒各位：在今天的電話會議中，我們將依據 1995 年《私人證券訴訟改革法》（Private Securities Litigation Reform Act of 1995）的定義，發表若干前瞻性陳述。這些前瞻性陳述（包括目標、預期、計畫、前景、成長潛力、事件時程、未來結果與財務指引）係基於目前資訊、假設與預期；其本質上可能變動，並涉及多項風險與不確定性，可能導致實際結果出現重大差異。

These factors and other risks associated with our business can be found in our filings made with the SEC. You are cautioned 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.

上述因素及與我們業務相關的其他風險，詳見我們向美國證券交易委員會（SEC）提交的文件。敬請注意勿過度依賴這些前瞻性陳述；其僅截至今日作成。除法律要求外，隨著情勢變化，我們不承擔更新或修訂這些前瞻性陳述的義務。

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

現在我將電話交給 Catherine 進行開場致詞。

Thank you, Al. Good afternoon, everyone, and thank you for joining us today to discuss our first quarter 2026 results.

謝謝你，Al。各位下午好，感謝各位今天與我們一同討論 2026 年第一季業績。

ACADIA delivered a solid start to the year with total revenue of $268 million in the first quarter, representing 11% year over year growth on an adjusted basis. DAYBUE had an especially strong quarter with sales of $101 million, up an impressive 20%, our highest year over year growth since the third quarter of 2024, marking an excellent start to the year.

ACADIA 在今年開局表現穩健，第一季總營收為 2.68 億美元；以調整後基礎計算，年增 11%。DAYBUE 本季表現尤其強勁，銷售額達 1.01 億美元，年增達 20%，為自 2024 年第三季以來最高的年增率，為今年帶來極佳的開端。

We are excited about the successful launch of DAYBUE STIX with strong feedback from both caregivers and healthcare providers. As announced last month, DAYBUE STIX is now broadly available across the United States, and we're seeing strong early uptake from both new and previously discontinued patients that gives us confidence in our growth outlook.

我們對 DAYBUE STIX 的成功上市感到振奮，並已收到照護者與醫療照護提供者的強烈正面回饋。如同上月公告，DAYBUE STIX 現已在美國全境廣泛供應；我們也看到新病患與先前停用病患的早期採用情況強勁，讓我們對成長展望更具信心。

NUPLAZID sales were $167 million in the first quarter, up 6% year-over-year on an adjusted basis. The first quarter performance reflects that some patients were slower to refill than in prior years. We are pleased to report that these refill dynamics have since normalized. Importantly, we saw double-digit referral growth in the first quarter and robust demand growth at 8%, even prior to the expected impact of the recent sales force expansion. I'm pleased to share that we are reaffirming our 2026 net sales guidance for both DAYBUE and NUPLAZID.

NUPLAZID 第一季銷售額為 1.67 億美元；以調整後基礎計算，年增 6%。第一季表現反映出部分病患的續配速度較往年偏慢。我們很高興回報，這些續配動態此後已恢復正常。重要的是，我們在第一季看到轉介量呈現雙位數成長，且需求成長強勁達 8%，甚至在近期擴編銷售團隊的預期影響反映之前即已如此。我也很高興分享，我們重申 2026 年 DAYBUE 與 NUPLAZID 兩項產品的淨銷售額指引。

Looking at our pipeline, we have several significant catalysts on the horizon. Most notably, we are approaching the highly anticipated Phase 2 readout for Remlifanserin and Alzheimer's disease psychosis, which we continue to expect to share results from in the August to October timeframe. This represents a key inflection point for our company and could unlock substantial value given the significant unmet medical need in this indication.

就研發管線而言，未來有數個重要催化劑即將到來。最值得關注的是，我們正接近 Remlifanserin 用於阿茲海默症精神病（Alzheimer's disease psychosis）的第二期試驗讀出；我們仍預期在 8 月至 10 月期間分享結果。這對公司而言是一個關鍵轉折點；鑑於該適應症存在顯著未被滿足的醫療需求，這項進展可能釋放可觀價值。

Additionally, the timing of our Phase 3 study in Japan for trofinetide has accelerated, and we now expect results in the September to November timeframe of this year. I want to remind everyone of the tremendous opportunity we have across our pipeline. We have four molecules targeting large markets with a combined full peak sales potential of $11 billion.

此外，我們在日本進行的 trofinetide 第三期研究時程已加速，目前預期將於今年 9 月至 11 月期間公布結果。我想提醒各位，我們的研發管線蘊含龐大機會。我們有四個分子藥物鎖定大型市場，合計的完整峰值銷售潛力達 110 億美元。

With approximately $4 billion of that specifically attributable to Remlifanserin across the ADP and Lewy Body Dementia Psychosis indications, this underscores the transformative potential of our research and development efforts.

其中約 40 億美元可歸因於 Remlifanserin 在阿茲海默症精神病（ADP）與路易氏體失智症精神病（Lewy Body Dementia Psychosis）兩項適應症的機會，凸顯我們研發投入的變革性潛力。

With that, I'll now turn the call over to Tom to provide a more detailed insight into our commercial performance.

接下來，我將把電話交給 Tom，請他更深入說明我們的商業表現。

Thank you, Catherine. Let me dive into the details of our first quarter performance. Starting with DAYBUE, I'm pleased to report another excellent quarter with revenue of $101 million, representing 20% year over year growth. This was another record quarter for unique patients receiving shipments, highlighting the continued momentum and durability of the DAYBUE franchise.

謝謝你，Catherine。我來深入說明第一季表現細節。先從 DAYBUE 開始，我很高興回報本季再創佳績，營收達 1.01 億美元，年增 20%。本季再次創下接受出貨的獨立病患數新高，凸顯 DAYBUE 產品線持續的動能與韌性。

Growth was fueled by robust referral volumes, driven by new patient starts, alongside meaningful reengagement of previously discontinued patients following the recent approval and launch of the new powder for oral solution formulation of Trofinitide, DAYBUE STIX.

成長動能來自強勁的轉介量，主要由新病患啟用所帶動；同時，隨著 Trofinitide 口服溶液用新粉末劑型（DAYBUE STIX）近期獲准並上市，我們也看到先前停用病患的顯著回流。

During the first quarter, we launched DAYBUE STIX with a focus on sense of excellence to ensure optimal launch execution while gathering valuable real-world feedback. We've been extremely pleased with both the initial uptake and positive experiences we've received from both caregivers and healthcare providers. Through Q1, we received DAYBUE STIX prescriptions for more than 250 individual patients, demonstrating strong early demand for the new formulation.

第一季期間，我們推出 DAYBUE STIX，並以卓越品質為核心，確保上市執行最佳化，同時蒐集寶貴的真實世界回饋。我們對初期採用情況以及照護者與醫療照護提供者所回饋的正面使用經驗感到非常滿意。截至第一季，我們已收到超過 250 位個別病患的 DAYBUE STIX 處方，顯示新劑型具備強勁的早期需求。

Notably, nearly 30% of these patients were either treatment-naive or restarting therapy, aligning with our expectations and further supporting DAYBUE's growth outlook. In addition, we're also seeing strong interest from existing patients in switching to the STIX formulation. Collectively, this early experience demonstrates how DAYBUE Stix can help retain current patients Bring discontinued patients back into therapy, and grow the treated patient population, aligning closely with our long-term growth strategy for DAYBUE.

值得注意的是，其中近 30% 的病患為未曾接受治療者或重新開始治療者，符合我們的預期，並進一步支持 DAYBUE 的成長展望。此外，我們也看到既有病患對轉換至 STIX 劑型展現高度興趣。整體而言，這些早期經驗顯示 DAYBUE Stix 有助於留住現有病患、讓停用病患回到治療中，並擴大接受治療的病患族群，與我們 DAYBUE 的長期成長策略高度一致。

From a patient and caregiver perspective, DAYBUE STIX offers meaningful advantages, including flexible dosing volume, potentially shorter dosing time, a preservative-free formulation, no requirement for refrigeration, and enhanced portability.

從病患與照護者的角度來看，DAYBUE STIX 提供具意義的優勢，包括可彈性調整的給藥體積、可能更短的給藥時間、無防腐劑配方、無需冷藏，以及更佳的可攜性。

These attributes are resonating strongly, with early feedback reinforcing the value of the new formulation, as you can see on this slide. Caregiver response has been particularly positive, with more than 80% of those who have tried STIX reporting high satisfaction, complemented by strong endorsement from healthcare providers across RHEP centers of excellence where the product was available through the first quarter.

這些特性引起了強烈共鳴，正如您在本張投影片所見，早期回饋進一步強化了新配方的價值。照護者的反應尤其正面，已試用 STIX 的人當中有超過 80% 回報高度滿意；同時，在第一季期間產品於 RHEP 卓越中心供應的情況下，也獲得醫療照護提供者的強力支持。

Following the focused launch, we announced in early April that DAYBUE STIX is now fully available in the US. We look forward to seeing the continued impact of this broader rollout for patients and caregivers. Outside of the US, our global named patient supply programs continue to contribute meaningfully to our growth through the first quarter. The number of patients receiving products through our NPS programs continues to increase over time, providing important access to patients.

在聚焦式上市之後，我們於 4 月初宣布 DAYBUE STIX 現已在美國全面供應。我們期待看到這次更廣泛的推廣持續為病患與照護者帶來影響。在美國以外，我們的全球具名病患供藥（NPS）計畫在第一季持續對成長做出重要貢獻。透過 NPS 計畫取得產品的病患人數隨時間持續增加，為病患提供重要的用藥可近性。

The recent Delphi expert consensus reinforces DAYBUE's position as the standard of care for Rett syndrome, reflecting broad adoption across sense of excellence and accelerating uptake among clinicians treating Rett patients. This important publication demonstrates that Rett syndrome experts agree that DAYBUE plays a crucial role in patient care, including the importance of initiating treatment early and dosing individualized to the patient's needs. The Delphi publication adds to the growing body of real-world experience supporting DAYBUE, complementing our robust clinical trial programs that support the meaningful impact that Trofinitide can make for patients living with Rett syndrome.

近期的 Delphi 專家共識強化了 DAYBUE 作為雷特氏症（Rett syndrome）標準照護的地位，反映其在卓越中心的廣泛採用，並加速臨床醫師在治療雷特氏症病患時的使用。這篇重要的出版物顯示，雷特氏症專家一致認為 DAYBUE 在病患照護中扮演關鍵角色，包括及早啟動治療的重要性，以及依病患需求進行個別化劑量調整。Delphi 出版物為支持 DAYBUE 的日益增加之真實世界經驗再添一筆，並與我們強健的臨床試驗計畫相互補充，進一步支持 Trofinitide 能為雷特氏症病患帶來具意義的影響。

Taken together, the successful launch of DAYBUE STIX, combined with sustained referral strength and durable patient persistence, physicians DAYBUE for continued growth through 2026 and beyond.

綜合而言，DAYBUE STIX 的成功上市，加上轉介力道持續強勁與病患長期持續用藥的穩健表現，使醫師對 DAYBUE 在 2026 年及其後的持續成長充滿信心。

Now turning to NUPLAZID, which delivered sales of $167 million in the first quarter, representing 6% growth year over year on an adjusted basis. I'd like to walk through the dynamics behind the quarter and explain why our confidence in full-year performance remains strong.

接著談 NUPLAZID，第一季銷售額為 1.67 億美元，按調整後口徑計算，年增 6%。我想帶大家了解本季背後的動態，並說明為何我們對全年表現仍維持強勁信心。

Starting at the top of the funnel, physician referral growth was strong at approximately 11% year over year, even ahead of the anticipated impact of our sales force expansion, which was completed in the quarter. This level of referral growth reflects continued physician confidence in NUPLAZID, driving strong underlying demand.

從漏斗頂端來看，醫師轉介成長強勁，年增約 11%，甚至早於我們在本季完成的銷售團隊擴編所預期帶來的影響。這樣的轉介成長水準反映醫師對 NUPLAZID 的持續信心，帶動強勁的基本需求。

However, as Catherine noted, first-quarter performance was impacted by a temporary increase in patients taking longer than expected to refill their prescriptions. This dynamic emerged in January and extended it to early February, as refill timing lagged historical first-quarter patterns. Importantly, these delays proved temporary. Patients who were late to fill returned in the latter part of the quarter, and we have now returned to normal patterns.

然而，如 Catherine 所提到，第一季表現受到一項暫時性因素影響：部分病患補領處方的時間比預期更久。此一情況在 1 月出現並延續至 2 月上旬，補藥時點落後於過往第一季的歷史模式。重要的是，這些延遲證明只是暫時性的。補領較晚的病患在本季後段回流，我們目前已回到正常模式。

Despite the short-term timing impact, NUPLAZID delivered 8% year over year demand growth in the quarter, reinforcing our confidence in the full-year outlook. As a reminder, our commercial strategy is focused on driving earlier awareness and use of NUPLAZID in the Parkinson's disease psychosis journey through smart, disciplined execution.

儘管短期時點因素造成影響，NUPLAZID 本季仍實現年增 8% 的需求成長，進一步強化我們對全年展望的信心。提醒一下，我們的商業策略聚焦於以聰明且嚴謹的執行，在帕金森氏病精神病（Parkinson's disease psychosis）的病程中，推動更早的 NUPLAZID 認知與使用。

We're sharpening prescriber reach, improving call quality, and maintaining tight segmentation, while strengthening field and digital engagement in order to engage physicians earlier and convert strong referral momentum into improved pull-through.

我們正提升處方醫師觸及、改善拜訪品質並維持嚴謹的分眾，同時強化第一線與數位互動，以便更早與醫師接觸，並將強勁的轉介動能轉化為更佳的後續拉動（pull-through）。

Building on this foundation, we expect to realize the full impact of the recent 30% expansion of our customer-facing teams by late 2026 and into next year as we extend these capabilities across a broader target universe. In addition, we anticipate further benefits from our direct-to-consumer efforts.

在此基礎上，隨著我們把這些能力延伸至更廣泛的目標族群，我們預期近期客戶面向團隊 30% 的擴編，其完整效益將在 2026 年下半年並延續至明年逐步顯現。此外，我們也預期直面消費者（DTC）推廣將帶來進一步效益。

We've recently renewed our partnership with Ryan Reynolds for the unbranded More to Parkinson's campaign, reflecting its strong resonance with patients and caregivers, enabling us to introduce new content and creative to further raise awareness of Parkinson's disease psychosis.

我們近期已與 Ryan Reynolds 續約合作，延續不具品牌識別的「More to Parkinson's」活動，反映該活動在病患與照護者間引發強烈共鳴，並使我們得以推出新內容與創意，進一步提升對帕金森氏病精神病的認知。

Since launching the campaign, awareness of hallucinations and delusions amongst the Parkinson's disease community has increased from 8% to over 30%, underscoring the campaign's significant impact. We're complementing this with refreshed branding creative on nuplazid.com to engage patients earlier in their journey and clearly reinforce NUPLAZID as the only FDA-approved treatment for Parkinson's disease psychosis.

自活動推出以來，帕金森氏病社群對幻覺與妄想的認知已由 8% 提升至超過 30%，凸顯該活動的顯著影響。我們也在 nuplazid.com 以更新的品牌創意加以配合，讓病患在病程更早期就能被觸及，並清楚強化 NUPLAZID 是唯一獲 FDA 核准用於帕金森氏病精神病的治療。

I'd also like to highlight a significant milestone for NUPLAZID. This year marks the 10-year anniversary of its FDA approval. Over the past decade, nearly 100,000 patients, along with their families and caregivers have benefited from this therapy. This milestone underscores both the durability of the NUPLAZID franchise and its meaningful impact on the Parkinson's disease community.

我也想強調 NUPLAZID 的一項重要里程碑。今年是其獲 FDA 核准的第 10 週年。過去十年來，近 10 萬名病患以及其家人與照護者受惠於此療法。這項里程碑凸顯 NUPLAZID 產品線的持久性，以及其對帕金森氏病社群所帶來的具意義影響。

In summary, NUPLAZID remains firmly on track for another strong year with continued referral momentum for the scaling impact of our expanded sales force and ongoing market development supporting our path towards approximately $1 billion in annual sales by 2028.

總結而言，NUPLAZID 仍穩健朝向再創強勁年度表現的軌道前進；在轉介動能持續之下，擴編後銷售團隊的規模化效益與持續的市場開發，將支持我們朝 2028 年年銷售額約 10 億美元的目標邁進。

And with that, I'll now turn the call over to Liz to provide an update on our pipeline developments.

接下來，我將把電話會議交給 Liz，請她更新我們的研發管線進展。

Thank you, Tom. Before turning to pipeline updates, I want to briefly address the retirement announcement we shared last week. For personal reasons, I've decided to retire by year-end. But while we seek the right next head of R&D, I remain fully engaged in driving our pipeline forward. We will ensure continuity through this transition, including supporting the upcoming Phase 2 readouts and early Phase 3 planning for Remlifanserin.

謝謝你，Tom。在進入管線更新之前，我想簡要說明我們上週分享的退休公告。基於個人因素，我已決定在年底前退休。但在我們尋找合適的下一任研發主管期間，我仍將全力投入推動管線向前。我們將確保此過渡期間的延續性，包括支持即將公布的第 2 期結果，以及 Remlifanserin 的早期第 3 期規劃。

With that context, I'll now walk through the key R&D progress for the quarter. I'm pleased to share updates on our pipeline, which continues to offer meaningful opportunity with real momentum building across multiple programs. Across our eight disclosed programs, we continue to anticipate initiating five additional Phase 2 or Phase 3 studies by the end of 2027, demonstrating the breadth and depth of our development portfolio.

在此背景下，我接著說明本季研發的關鍵進展。我很高興分享我們的管線更新；我們的管線持續提供具意義的機會，且多個專案正累積實質動能。在我們已揭露的八個專案中，我們仍預期在 2027 年底前再啟動五項第 2 期或第 3 期研究，展現我們開發組合的廣度與深度。

Most recently, we successfully initiated our first-in-human study of ACP-271 in healthy volunteers, and I'm pleased to report that the study is going well to date. We continue to advance enrollment across several key studies. Our Phase 2 study of ACP-211 in major depressive disorder is progressing, as is our Phase 2 study of Remlifanserin in Lewy body dementia/cytosis.

最近，我們已成功在健康受試者中啟動 ACP-271 的首次人體試驗（first-in-human），很高興回報目前研究進展順利。我們也持續推進數項關鍵研究的收案。ACP-211 用於重度憂鬱症的第 2 期研究正在推進中，Remlifanserin 用於路易氏體失智症／精神病的第 2 期研究亦然。

And of course, both of these programs represent significant opportunities to address substantial unmet medical needs. Looking ahead, we currently anticipate reporting four Phase 2 or Phase 3 study readouts by the end of 2027. And of course, the closest disease is the top-line results from our Phase I2 study of Remlifanserin in Alzheimer's disease psychosis.

當然，這兩個專案都代表著解決重大未被滿足醫療需求的重要機會。展望未來，我們目前預期在 2027 年底前公布四項第 2 期或第 3 期研究的讀出結果。而最近的一項，則是 Remlifanserin 用於阿茲海默症精神病之第 I2 期研究的主要結果（top-line results）。

The Alzheimer's study is still unrolling, and the enrollment dynamics continue to support our expectation for top-line results in the August through October 2026 timeframe. As a reminder, throughout this study, we've focused on ensuring our patient population has biomarker-confirmed Alzheimer's disease, which we think could be an important component of both technical and regulatory success. We're excited for this readout and what it could mean for the future of the company if successful, but most importantly, as a step towards relief for the patients and families affected by this challenging condition.

阿茲海默症研究仍在進行中，收案動態持續支持我們對 2026 年 8 月至 10 月期間取得主要結果的預期。提醒一下，在整個研究過程中，我們著重確保病患族群為以生物標記確認的阿茲海默症，我們認為這可能是技術與法規成功的重要要素。我們對這次讀出感到振奮；若能成功，將可能對公司未來帶來重大意義，但更重要的是，這將是朝向為受此艱難病況影響的病患與家庭帶來緩解的一步。

Turning to regulatory and international developments, the Trofinitide reexamination process in Europe remains ongoing, and we continue to expect that process to conclude by late June. We remain focused on working closely with European regulators to address their questions and support the positive benefit-risk profile of Trofinitide for patients with Rett syndrome. In Japan, enrollment in our Phase 3 trial with Trofinitide has been progressing exceptionally well, and I'm pleased to share that we now anticipate completing enrollment this quarter.

談到法規與國際進展，Trofinitide 在歐洲的重新審查程序仍在進行中，我們仍預期該程序將於 6 月下旬前完成。我們仍專注於與歐洲監管機構密切合作，以回應其問題，並支持 Trofinitide 用於雷特氏症候群患者的正向效益—風險概況。在日本，我們的 Trofinitide 第 3 期試驗收案進展非常順利，我也很高興分享，我們目前預期將在本季完成收案。

This accelerated timeline positions us for top-line results in the September through November timeframe this year, which represents an earlier completion than we previously anticipated. Now, as a reminder, this is a small study that was designed with regulators to provide descriptive information on Japanese patients receiving Trofinitide.

這一加速的時程使我們有望在今年 9 月至 11 月期間取得主要（top-line）結果，較我們先前預期更早完成。另外提醒一下，這是一項小型研究，係與監管機構共同設計，用以提供日本患者接受 Trofinitide 治療的描述性資訊。

We expect this study to provide the remaining new data needed for our Japanese filing package, which will rely largely on the LAVENDER trial to establish Trofinitide's efficacy and safety, with an expected regulatory submission in 2027, these pipeline developments underscore our commitment to advancing innovative treatments across neurological and rare diseases and we look forward to sharing more updates as these programs continue to progress.

我們預期本研究將提供日本申報資料包所需的其餘新增數據；該申報將主要依賴 LAVENDER 試驗來確立 Trofinitide 的療效與安全性，並預期於 2027 年進行監管送件。這些研發管線進展凸顯我們致力於在神經疾病與罕見疾病領域推進創新治療；隨著各項計畫持續推進，我們也期待分享更多更新。

And with that, I'll turn the call over to Mark.

接下來，我把電話交給 Mark。

Thank you, Liz. I'll now walk you through our first quarter 2026 financial results. Starting with our revenue performance, total revenue for the quarter was $268 million, up 11% compared to adjusted total revenue in the first quarter of 2025.

謝謝你，Liz。我現在帶各位回顧我們 2026 年第一季的財務結果。先從營收表現開始，本季總營收為 2.68 億美元，較 2025 年第一季的調整後總營收成長 11%。

NUPLAZID generated $167 million of net product sales in the first quarter, representing 6% growth year over year on an adjusted basis. As Tom discussed, we are very encouraged by the strong demand growth and referral growth in the quarter, which we saw even before the anticipated impact from the fieldforce expansion that was completed in the quarter.

NUPLAZID 第一季淨產品銷售額為 1.67 億美元，以調整後口徑計算，年增 6%。如 Tom 所述，我們對本季強勁的需求成長與轉介成長感到非常振奮，而且這些成長甚至發生在本季完成的業務團隊（field force）擴編所預期帶來的影響之前。

The gross to net adjustment for NUPLAZID in the quarter was 22.1%. As stated in our press release, NUPLAZID year over year growth metrics are derived by comparing our Q1 2026 GAAP NUPLAZID net sales to our Q1 2025 non-GAAP NUPLAZID adjusted net sales.

本季 NUPLAZID 的毛額到淨額（gross-to-net）調整為 22.1%。如我們新聞稿所述，NUPLAZID 的年對年成長指標係以 2026 年第一季 GAAP 口徑的 NUPLAZID 淨銷售額，對比 2025 年第一季非 GAAP 口徑的 NUPLAZID 調整後淨銷售額計算。

DAYBUE delivered strong performance with $101 million in net sales, up 20% year over year. Our DAYBUE results reflect the robust momentum Tom described in both the US market and through our international programs. The gross to net adjustment for Debut in the quarter was 25.8%.

DAYBUE 表現強勁，淨銷售額達 1.01 億美元，年增 20%。我們的 DAYBUE 成果反映了 Tom 所描述的強勁動能，涵蓋美國市場以及我們的國際計畫。本季 DAYBUE 的毛額到淨額調整為 25.8%。

Turning to our operating expenses, research and development expenses were $76.9 million, compared to $78.3 million in the first quarter of 2025. Our SG&A expenses were $171 million compared to $126.4 million in the first quarter of 2025, reflecting our continued investments in our commercial franchises with increased marketing investments for NUPLAZID and the expanded field footprint for both NUPLAZID and DAYBUE, which both took place after the first quarter of 2025, which is an important consideration in any year over year comparison.

接著看營業費用，研發費用為 7,690 萬美元，較 2025 年第一季的 7,830 萬美元略降。銷售、一般及行政（SG&A）費用為 1.71 億美元，較 2025 年第一季的 1.264 億美元增加，反映我們持續投資於商業化事業，包括對 NUPLAZID 增加行銷投資，以及同時擴大 NUPLAZID 與 DAYBUE 的業務覆蓋範圍；而這兩項擴編皆發生在 2025 年第一季之後，因此在進行任何年對年比較時，這是一項重要考量。

Our cash position remains exceptionally strong with $851 million at the end of the first quarter as compared to $820 million at the end of the fourth quarter. This increase reflects our positive operating cash flow generation and positions us well to execute on our strategic priorities.

我們的現金部位依然非常強勁，第一季末為 8.51 億美元，相較第四季末的 8.20 億美元增加。此一增加反映我們營運現金流的正向貢獻，並使我們能夠更好地執行策略優先事項。

Moving to guidance, I'm pleased to reaffirm our full-year 2026 guidance for net sales and expenses. In terms of quarterly progression, we expect total revenue to be back-end loaded as the year progresses, with a greater sales contribution from both brands in the second-half of the year, driven by the expected productivity ramp from our expanded NUPLAZID Field Force, coupled with broader availability and adoption of DAYBUE STIX.

接著談財測，我很高興重申我們 2026 全年淨銷售與費用指引不變。就季度走勢而言，我們預期全年總營收將呈現後段偏重（back-end loaded），隨著年度推進，下半年兩個品牌的銷售貢獻將更高，主要由擴編後的 NUPLAZID 業務團隊生產力爬坡所帶動，並結合 DAYBUE STIX 更廣泛的供應與採用。

With that financial overview, I'll turn the call back to Kathryn for her closing remarks.

以上為財務概覽，接下來我把電話交回 Kathryn，請她做結語。

Thank you, Mark. As we wrap up today's call, I want to highlight the key milestones and catalysts that make 2026 such an exciting and potentially transformative year for ACADIA.

謝謝你，Mark。在結束今天的電話會議前，我想強調幾個關鍵里程碑與催化劑，讓 2026 年對 ACADIA 而言格外令人振奮，且可能具有轉型意義。

First and foremost, we're approaching our highly anticipated top-line results for Remlifanserin in Alzheimer's disease psychosis, which we expect to report in the August to October timeframe. This represents the most significant near-term catalyst for our company, with the potential to unlock tremendous value and address a massive unmet medical need affecting millions of patients and their families.

首先也是最重要的，我們正接近備受期待的 Remlifanserin 用於阿茲海默症精神病（psychosis）的主要（top-line）結果，我們預期將在 8 月至 10 月期間公布。這是公司近期最重要的催化劑，具有釋放巨大價值的潛力，並可滿足影響數百萬患者及其家庭的重大未被滿足醫療需求。

The ADP market represents a substantial opportunity with no currently approved therapies, and successful results could position Remlifanserin as a cornerstone therapy in this underserved patient population. We also anticipate top-line results from our Japan Phase 3 trial with Trofinitide later this year, which could establish an important new market for debut.

阿茲海默症精神病（ADP）市場代表一個龐大機會，目前尚無核准療法；若結果成功，Remlifanserin 有望成為此一服務不足患者族群的基石療法。我們也預期今年稍晚將取得 Trofinitide 日本第 3 期試驗的主要（top-line）結果，這可能為 DAYBUE 建立一個重要的新市場。

This accelerated timeline reflects strong international engagement and our commitment to bringing innovative treatments to patients worldwide. Importantly, as we head into these upcoming data readouts, while Liz has announced her intention to retire at the end of the year, we are grateful that she will continue to lead R&D to provide continuity and leadership while we look to find a strong replacement.

這一加速時程反映了強勁的國際參與，以及我們致力於將創新治療帶給全球患者的承諾。重要的是，在我們迎接這些即將到來的數據揭盲之際，儘管 Liz 已宣布她打算在年底退休，我們很感謝她將持續領導研發工作，在我們尋找合適且強而有力的接任者期間，提供延續性與領導力。

Beyond these clinical and regulatory milestones, we have a strong commercial foundation, and we're pleased to reaffirm our 2026 financial guidance for total revenues of $1.22 billion to $1.28 billion.

除了這些臨床與法規里程碑之外，我們也擁有穩固的商業化基礎，並很高興重申 2026 年財務指引：總營收為 12.2 億至 12.8 億美元。

Furthermore, our cash balance of $851 million provide us with significant strategic flexibility, enabling us to pursue business development opportunities, including potential acquisitions, licenses, and partnerships that could complement our existing portfolio and further accelerate our growth trajectory.

此外，我們 8.51 億美元的現金餘額為我們提供了顯著的策略彈性，使我們能夠追求商業發展機會，包括潛在的併購、授權與合作夥伴關係，以補強既有產品組合並進一步加速成長軌跡。

We remain actively engaged in evaluating opportunities that align with our strategic focus on neurological and rare disease with significant unmet need. Throughout all of these initiatives, we remain steadfast in our mission to turn scientific promise into meaningful innovation for underserved communities.

我們仍積極評估與我們策略重點一致的機會，聚焦於具有重大未被滿足需求的神經疾病與罕見疾病。在所有這些倡議中，我們始終堅定於使命：將科學的承諾轉化為對服務不足社群具有意義的創新。

Every program in our pipeline, every commercial initiative we undertake, and every strategic decision we make is guided by our commitment to bring life-changing treatments to patients and families who need them most. The combination of our strong commercial performance, robust pipeline, and solid financial foundation positions ACADIA exceptionally well for both near-term catalysts and long-term sustainable growth. We're excited about the opportunities ahead and look forward to sharing our progress with you throughout the year.

我們研發管線中的每一個計畫、我們推動的每一項商業化舉措，以及我們做出的每一項策略決策，都以我們的承諾為指引：為最需要的患者與家庭帶來改變生命的治療。我們強勁的商業表現、充實的研發管線與穩健的財務基礎相結合，使 ACADIA 在近期催化劑與長期可持續成長方面都具備極佳的定位。我們對未來的機會感到振奮，並期待在今年持續與各位分享我們的進展。

And with that, we're happy to take your questions. Operator?

接下來，我們很樂意回答各位的問題。接線員？

(Operator Instructions)

（接線員指示）

Tessa Romero, JPMorgan.

Tessa Romero，摩根大通。

Hey, guys. Thanks so much for taking our question this afternoon. So, I wanted to ask a pipeline one here. So, where are you more precisely in terms of enrollment of the Phase 2 RADIANT study of Remlifanserin and Alzheimer's disease psychosis? And how confident are you in your timeline from August to October of this year? When might you see the last patient in?

嗨，各位。非常感謝今天下午讓我們提問。我想問一個關於研發管線的問題。就 Remlifanserin 用於阿茲海默症精神病的第 2 期 RADIANT 研究而言，目前收案進度更精確地說到哪個階段了？你們對今年 8 月到 10 月這個時程有多大把握？預計何時會完成最後一位受試者入組？

And then second question is just, how is enrollment going in your Phase 2 OMERA study and Lewy body dementia psychosis? And what is the right way to think about the potential timeline to data there as well? Thank you.

然後第二個問題是，你們在第二期 OMERA 研究以及路易體失智症精神病（Lewy body dementia psychosis）的收案進度如何？另外，應該如何看待那邊資料讀出的潛在時間表？謝謝。

Thanks, Tess. I'm going to ask Liz to take us through the timeline for Remlifanserin.

謝謝，Tess。我請 Liz 帶我們說明 Remlifanserin 的時間表。

Sure. So, hi, Kath, and thanks for the question. So, first off for the ADP program, we continue to feel very good about that August to October timeframe. And the study is still enrolling, but we are getting to the last phases of enrollment. So we feel confident about that timeline. That said, I'm not yet able to narrow that any further than what we have right now.

好的。嗨，Kath，謝謝你的問題。首先，就 ADP 計畫而言，我們仍然對 8 月到 10 月這個時間窗感到非常有把握。研究仍在收案中，但我們已進入收案的最後階段。因此我們對這個時程很有信心。不過，我目前還無法把時間再縮得比我們現在所提供的更精確。

As we look at Lewy body, I'm pleased with the enrollment progress that we have there. I don't think we've yet shared publicly what our expectations around the end are. We wanted to get a ways into enrollment. So I do look forward to sharing more about that in future, but so far, pleased and on track with what I was hoping for.

至於路易體方面，我對目前的收案進展感到滿意。我想我們尚未在公開場合分享我們對結束時間點的預期。我們希望先讓收案推進一段時間。所以我也期待未來能分享更多，但到目前為止，進展令人滿意，且符合我原先的期待。

Thanks, Tess.

謝謝，Tess。

Ash Verma, UBS.

UBS 的 Ash Verma。

Hey, thanks for taking our question. So maybe just on this upcoming Phase 2 study, I know you mentioned the biomarker-based selection for confirmation of the Alzheimer's patients as opposed to just looking at the clinical presentation. Can you help us explain a little bit why is that critical for clinical trial execution? And just in the real-world setting, I know patients are typically not diagnosed based on the clinical presentation and imaging. They are diagnosed based on community presentation and imaging and not necessarily biomarker confirmation. So how does that inform the applicability of the results to real world?

嗨，謝謝讓我們提問。關於即將進行的這項第二期研究，我知道你提到會用以生物標記為基礎的篩選來確認阿茲海默症患者，而不是只看臨床表現。你能否協助我們解釋一下，為什麼這對臨床試驗執行至關重要？另外在真實世界情境中，我知道病人通常不是以臨床表現加上影像、再加上生物標記確認來診斷。他們多半是依社區端的表現與影像來診斷，而不一定會做生物標記確認。那這會如何影響結果在真實世界的適用性？

And then secondly, just on ACP-204, so [aminiplasm] has a black box warning for this increased mortality in elderly patients, given that this is kind of a connection of that. Would the molecule still put the black box warning if it comes to the market? Thanks.

第二個問題是關於 ACP-204，[aminiplasm] 針對高齡患者死亡率增加有黑框警語，因為這算是相關聯的藥物。如果這個分子未來上市，是否仍會被加上黑框警語？謝謝。

All right. Thanks, Ash. Some comprehensive questions there for Liz to get to. Let's talk at the top and go down.

好的。謝謝，Ash。這些問題很全面，讓 Liz 來回答。我們先從第一個開始，依序往下。

There was a lot in there I was madly writing down, so hopefully I captured everything. So in terms of the biomarker basis, I think this has been a really interesting thing to launch in the Alzheimer's field with a number of years back, there was the idea of biomarkers being part of a clinical trial basis way of thinking about diagnosis.

你剛剛提到的內容很多，我一直在快速記錄，希望我都有抓到。就生物標記為基礎這點而言，我認為這是阿茲海默症領域一個很有意思的發展；幾年前開始就有人提出，生物標記應該成為臨床試驗設計中、用來思考診斷的一部分。

And at this point, it actually is considered part of the diagnostic pathway for Alzheimer's. I fully anticipate by the time we would make it to FDA with our potential packet for Remlifanserin that there would be an expectation that Alzheimer's disease is a biologically confirmed disease. And so we've put this in place to try to future-proof the program that we have.

而到目前為止，它其實已被視為阿茲海默症診斷流程的一部分。我完全預期，等到我們可能帶著 Remlifanserin 的資料包走到 FDA 時，會有一種期待：阿茲海默症必須是經生物學方式確認的疾病。因此我們把這個設計納入，是為了讓我們的計畫更具前瞻性、能因應未來要求。

And I think that probably touches a little bit on your point about real world. I think that the real world is starting to move that way as well. So, we think that this has an important component of regulatory success. I should note, it may also have a potential opportunity for improving technical success.

我想這也部分回應你提到的真實世界問題。我認為真實世界也正在朝這個方向前進。所以我們認為，這對法規核准的成功具有重要意義。我也要補充，這可能同時帶來提升技術成功率的機會。

There is a possibility that this helps you be more confident that the patient population you have is truly Alzheimer's and that there's less heterogeneity in that patient population from a response perspective. So, we think it's important on both aspects.

因為這有可能讓你更有信心：你所納入的病人族群確實是阿茲海默症，且從反應角度來看，族群的異質性更低。因此我們認為，這在兩個面向上都很重要。

Finally, to your point about the black box warning, it's a really great question. There was an FDA-used Margolis workshop, oh, achievers, probably about a year and a half ago at this point, and one of the discussion points was about the black box warning and for future agents, what kind of data might be necessary to help FDA make data-based decisions on individual agents.

最後，關於你提到的黑框警語，這是個非常好的問題。大約一年半前，FDA 曾舉辦一場 Margolis 工作坊（或類似活動），其中一個討論重點就是黑框警語：對於未來的藥物，可能需要什麼樣的資料，才能協助 FDA 針對個別藥物做出以資料為基礎的決策。

So, we attended that eagerly, learned from it, and have taken into account feedback that we got both through there and through other discussions about the kind of information we need to collect to be able to let FDA make a specific decision on Remlifanserin and whether it does or does not warrant such a box warring.

所以我們很積極地參與、從中學習，並把我們在那裡以及其他討論中得到的回饋納入考量，來規劃需要蒐集哪些資訊，讓 FDA 能就 Remlifanserin 做出具體判斷：它是否需要、或不需要這樣的黑框警語。

So, right now, I don't know, but we know the data we need to collect, and we do think that there is good reason to think that this could be a path forward without of black box, but it's going to depend on the data at the end of the day.

因此，目前我還不知道最終答案，但我們知道需要蒐集哪些資料；而我們也確實認為，有充分理由相信這可能是一條不需要黑框警語的前進路徑，但最終仍取決於最後的資料結果。

Thanks, Ash.

謝謝，Ash。

Ritu Baral, TD Cowen.

TD Cowen 的 Ritu Baral。

Hi, guys. Thanks for taking the question. I've got some more ramless answering questions as well, extending from clinical into commercial.

嗨，各位。謝謝讓我提問。我也有一些更偏「無所不包」的問題，從臨床延伸到商業面。

One, as we think about that Phase 2 data that's coming, what should our expectations around either effect size or Delta on the SAPS HDB. Is there an accepted minimal clinically important difference here and what frames success on a statistical level?

第一，當我們思考即將公布的第二期資料時，對於 SAPS HDB 的效果量或差值（Delta），我們應該抱持什麼樣的預期？這裡是否有公認的最小臨床重要差異（MCID），以及在統計層面上，什麼樣的結果可被視為成功？

And then as we look at our market model, just given the recent competitive approval of an Alzheimer's agitation drug, how should we be thinking about differential diagnosis between the two indications, accurate diagnosis, and sort of decision, treatment decisions between the two.

第二，從市場模型來看，考量近期競品在阿茲海默症躁動（agitation）藥物上的核准，我們應該如何思考兩個適應症之間的鑑別診斷、正確診斷，以及兩者之間的治療決策？

So with all the interest in Remlifanserin, so I'll ask Liz to kick that off and then maybe Liz and Tom can both talk to the market a little bit as well.

大家對 Remlifanserin 很有興趣，所以我先請 Liz 開頭回答，之後也許 Liz 和 Tom 都可以再談談市場面。

Yeah, absolutely. So in general terms of what we should all be looking for and what defines Phase 2 success for us as we are walking into this readout. There are a few things that I'm looking for. I mean, the main thing really with any Phase 2 is what you're looking for is Phase 3 enabling data. You're looking for information that helps you know what to do in a Phase 3, any modifications you may need to make, et cetera.

好的，當然。就整體而言，當我們走向這次讀出時，大家應該看什麼、以及對我們來說第二期成功的定義是什麼。我會看幾個重點。其實任何第二期試驗最主要要看的，就是能否提供支持第三期的資料。你要找的是能幫助你知道第三期該怎麼做的資訊，例如可能需要做哪些調整等等。

Beyond that, I'll be looking for continued information that suggests that Remlifanserin is delivering results that are consistent with our TPP. We're not going to know all of those definitively coming out of Phase 2, and there will be some things that we already feel pretty good about, but I'll be looking.

除此之外，我也會持續關注是否有資訊顯示 Remlifanserin 的結果與我們的目標產品特性（TPP）一致。我們不會在第二期結束後就把所有項目都完全確定下來；有些事情我們已經相當有把握，但我仍會持續觀察。

We want to make sure that we've got something that can be dosed once a day, that can be done easily with respect to con meds, with respect to food, anything that makes it easy for patients to take their drugs. We are, of course, looking for efficacy. We'll be pleased with an effect size that's in line of what we're powered for, which is a 0.4 or moderate effect size.

我們希望確保這個藥能做到每日一次給藥，且在併用藥物、飲食等方面都能容易配合，任何能讓病人更容易服藥的因素都很重要。當然，我們也在看療效。如果效果量符合我們試驗設計的檢定力假設，也就是 0.4（中等效果量），我們就會感到滿意。

We'd be pleased with safety that looks similar to the Pimavanserin profile, and this part, of course, we definitely won't be able to definitively answer out of Phase 2, but continue data that suggests that there's no deleterious impact on movement, on cognition, which from the overall pimavanserin dataset we do feel good about, and hopefully we'll get some directional sense there.

我們會樂見其安全性看起來與 Pimavanserin 的特徵相近；當然，這一部分我們絕對無法在第二期試驗結束後就給出明確定論，但目前持續累積的數據顯示，對運動功能與認知沒有不利影響；就整體 pimavanserin 的資料集而言，我們對此感到放心，也希望能從中獲得一些方向性的訊號。

To the question about NCID on SAP HNB. They're not a well-establishment at this point. Part of what we would be doing for a dossier that would go into the FDA eventually is establishing that NCID based in part on the Phase 2 data that we have. We are, however, also looking at, in addition to just the delta, some responder levels, those who have improved by at least 30%, those who have improved by at least 50%, which we think help contextualize the meaningfulness of those results.

關於在 SAP HNB 上的 NCID 問題。目前尚未有良好且成熟的建立。我們未來提交給 FDA 的申報資料（dossier）的一部分工作，就是根據我們現有的第二期數據來建立該 NCID。不過，除了僅看差值（delta）之外，我們也在觀察一些反應者（responder）層級，例如改善至少 30% 的人、改善至少 50% 的人；我們認為這有助於將結果的臨床意義置於脈絡中加以解讀。

And then I think there was also question about the recent [axome] approval and agitation. I'll just briefly say, we're always happy to see more options for patients, Alzheimer's disease is a complex disease with many manifestations that are really profoundly impactful for patients and their families.

另外我想也有人問到近期 [axome] 的核准以及躁動（agitation）。我簡單說一下：我們總是樂於看到病患有更多治療選項；阿茲海默症是一種複雜疾病，具有多種表現，對病患及其家屬都會造成非常深遠的影響。

What I think is important to keep in mind is that we always did envision, as we looked at our business opportunity for Remlifanserin, that there is a potential competition, particularly including agents that would be approved for agitation, and that there are distinctions between agitation and psychosis.

我認為需要記住的一點是：在我們評估 Remlifanserin 的商業機會時，一直就預期可能會面臨競爭，特別是包含那些可能因治療躁動而獲准的藥物；而躁動與精神病性症狀（psychosis）之間是有區別的。

Agitation is complex. There are a lot of things that can play into it. It can stem from pain. It can stem from cognitive challenges, and it can stem from psychosis. For Remlifanserin, we are optimistic. There is some pimavanserin data suggesting that in those patients who have significant agitation and significant psychosis.

躁動是複雜的。有很多因素都可能造成。可能源自疼痛。可能源自認知方面的挑戰，也可能源自精神病性症狀。對於 Remlifanserin，我們保持樂觀。有一些 pimavanserin 的數據顯示，在那些同時具有顯著躁動與顯著精神病性症狀的病患中。

If their psychosis improved, it did seem to suggest that their agitation improved as well. So there may be an aspect of agitation, but I wouldn't expect that we would have impact on pain, pain-induced agitation, et cetera.

如果其精神病性症狀改善，似乎也暗示其躁動同樣有所改善。因此躁動可能有一部分會受到影響，但我不預期我們會對疼痛、疼痛誘發的躁動等產生影響。

And sort of on the flip side, if you look at molecules that are affected in agitation, there's not necessarily a good reason to believe that they'll be impactful on any of the things that are actually driving that agitation, like psychosis. I mean, actually, if you look at [dextro], oh goodness, if you look at various components, they actually can be associated with an increase in psychosis.

反過來看，如果你看那些針對躁動而作用的分子，並不一定有充分理由相信它們會對真正驅動躁動的因素（例如精神病性症狀）產生影響。我的意思是，實際上如果你看 [dextro]，噢天哪，如果你看各種成分，它們其實可能與精神病性症狀增加有關。

Taken together, I think we think that there's ample room for multiple players in this space and that effective players in agitation are going to be meaningfully impactful for the opportunity we've seen with (inaudible) answering.

綜合來看，我們認為這個領域有足夠空間容納多個參與者，而在躁動方面有效的參與者，將會對我們所看到的（聽不清）所對應的機會產生實質影響。

I think Liz has covered that brilliantly and (multiple speakers)

我想 Liz 已經非常精彩地涵蓋了這點，而且(多位講者)

Yigal Nochomovitz, Citigroup.

Yigal Nochomovitz，花旗集團。

Hi. This is Carolyn DePaul on Yigal. Thanks for taking our question. So, switching to DAYBUE STIX, you disclosed that 30% of patients are either treatment naive or returning after previously discontinuing the liquid formulation. Just wondering how this compares to your expectations for the launch. And do you still expect to capture 400 or over 400 incremental patients with STIX? And if so, what is the anticipated cadence for capturing those patients? Thanks.

嗨。我是代替 Yigal 的 Carolyn DePaul。謝謝你們回答我們的問題。那麼，轉到 DAYBUE STIX，你們揭露有 30% 的病患不是既有治療者（treatment naive），就是先前停用液體劑型後回來的病患。想請問這與你們對上市初期的預期相比如何？你們是否仍預期 STIX 能帶來 400 位或超過 400 位的新增病患？若是，預計吸收這些病患的節奏（cadence）會是如何？謝謝。

Perfect. Thanks for the question, Caroline. So let me provide some additional color on your question just regarding kind of our expectations and performance through the first quarter. So just as a reminder, our launch strategy was very focused on COEs through the first quarter. So we've not yet gone broadly into the community.

很好。謝謝你的問題，Caroline。我就你提到的、關於我們在第一季的預期與表現，補充一些說明。提醒一下，我們的上市策略在第一季是非常聚焦於 COE（卓越中心）。因此我們尚未在社區端廣泛推進。

However, we have been very pleased with the initial output that we've seen. So the 250 patients that or or the 250 prescriptions that we had, we actually shipped 220 of those in the quarter, which again, I think just talks to the fact that we're able to get this drug into patients' hands quickly.

不過，我們對目前看到的初期成果非常滿意。我們有 250 位病患、或說 250 張處方，其中實際在本季出貨了 220 份；我認為這再次說明我們能夠快速把藥品送到病患手上。

In terms of how it's doing business expectations, we would actually say that the ramp, in terms of speed that we're seeing here is actually going quicker than we anticipated. I mean, I think the 450 that you referenced is what we have spoken about at JPM.

就是否符合商業預期而言，我們會說目前看到的爬坡速度其實比我們預期更快。我的意思是，你提到的 450 是我們在 JPM 上曾談到的數字。

We still think that that holds true, and we have modeled that over a three-year period, which would basically get us two STIX being the dominant SKU by the end of that time. I think we may end up in a situation where it goes slightly quicker than that.

我們仍然認為這個判斷成立，而且我們是以三年的期間來建模；基本上到那個時間點，STIX 會成為主要的 SKU。我想我們最後可能會遇到一種情況：進展速度會比這個更快一些。

But again, I think the 30% that we're seeing is broadly in line with our expectations. And we're encouraged by the fact that it's not only returning patients, but naive patients as well, supplemented by the fact that we're also seeing significant interest from patients already receiving the liquid formulation. So I think taken together, it gives us real optimism for the future of day B more broadly and the role that STIX can really play in fueling that growth.

但再說一次，我認為目前看到的 30% 大致符合我們的預期。而且我們也受到鼓舞，因為其中不僅有回流病患，也有初次治療的病患；再加上我們也看到既有使用液體劑型的病患對此有顯著興趣。因此整體而言，這讓我們對 DAYBUE 更廣泛的未來，以及 STIX 在推動成長上能扮演的角色，感到非常樂觀。

Brian Abrahams, RBC Capital Markets.

Brian Abrahams，RBC 資本市場。

Hey, guys. Good afternoon. Thanks for taking my question. Maybe going back to Remli, as we think about Remli and what could generate success in the upcoming study, I guess, can you -- what exactly are the key differences on potency saturation, and receptor-binding properties that you might expect from 60 milligrams of Remli as compared to the marketed and current and previously tested dose of pimavanserin? Or should we think about this more as being -- just having a more homogenous population and a study design that leverages prior learnings and uses a more sensitive endpoint? Thanks.

嘿，各位。下午好。謝謝你們回答我的問題。也許回到 Remli：當我們思考 Remli 以及即將進行的研究中什麼可能帶來成功時，我想問的是——相較於已上市、目前以及先前測試過的 pimavanserin 劑量，60 毫克 Remli 在效價飽和度（potency saturation）與受體結合特性（receptor-binding properties）上，你們預期有哪些關鍵差異？或者我們應該把它更多視為——只是擁有更同質的族群，以及一個運用既往學習、並採用更敏感終點的研究設計？謝謝。

That's a great question, and I think we can think of it as potentially a little bit of both. What we do know from our prior pimavanserin work is that if you look over the exposure response range, there does seem to be a suggestion that at exposures that are higher than what you can get to with the currently marketed dose of pimavanserin, you are able to get greater efficacy.

這是個很好的問題，我想可以把它視為兩者皆有可能。我們從先前的 pimavanserin 研究中知道的是：如果你看暴露量—反應（exposure-response）的範圍，確實似乎有跡象顯示，在暴露量高於目前已上市 pimavanserin 劑量所能達到的情況下，可能可以獲得更高的療效。

So, there is at least a good reason to think that if we're able to push to higher exposures, as we are with the 60-milligram dose, we may be able to get further up on that exposure response curve. That said, even if that doesn't play out exactly the way that we're expecting it to, I do think that having a study design that is really specifically focused in on the Alzheimer's population, I think that's first and foremost our learning from regulatory in times past is that they're going to need data that are specific to that population, which as I mentioned before on this call, we're going the extra step in biomarker confirming.

因此，至少有充分理由認為：如果我們能把暴露量推到更高——就像我們用 60 毫克劑量所做的——我們或許能在那條暴露量—反應曲線上再往上走一些。話雖如此，即便結果沒有完全如我們預期地呈現，我仍認為採用一個真正聚焦於阿茲海默症族群的研究設計非常重要；我想這首先是我們過去從法規互動中學到的：他們會需要針對該族群的特定數據；而且如我先前在本次電話會議提到的，我們還會額外一步用生物標記（biomarker）來確認。

That's going to be important. And we think that it's going to be, we've done other modifications of things like trying to make sure that we have a slightly more severe baseline population in terms of their psychosis based on PIM data that suggested you get better responses there, as well as the fact that we're looking at endpoints that we think, SAPS H&D, as well as other things that we have in our study, like the NTIC, that we think may be better suited to being able to distinguish differences than the NTINH that we used way back in the day in our Phase 2 trial. So I think it's a little bit of all of the above.

那將會很重要。而且我們認為它將會是——我們也做了其他一些調整，例如嘗試確保在精神病症狀方面，我們的基線族群稍微更嚴重一些；根據 PIM 數據顯示，在那樣的族群中你會得到更好的反應。此外，我們也在看一些我們認為的終點指標，例如 SAPS H&D，以及我們研究中的其他項目，例如 NTIC；我們認為這些可能比我們很久以前在第二期試驗中使用的 NTINH，更適合用來區分差異。所以我想這些因素多少都有一些影響。

Thanks, Liz, and thanks for the question.

謝謝你，Liz，也謝謝你的提問。

Tazeen Ahmad, Bank of America.

Tazeen Ahmad，美國銀行。

Okay, thank you for taking my question. How are you thinking about the read-through from the Phase 2 study for Alzheimer's onto the Lewy body study itself? Going back to a few years ago when a similar study was done, Pima did seem to show a pretty strong signal there. So regardless of how it turns out for Phase 2 for Alzheimer's, how should we be thinking about the de-risking for Lewy body for next year? Thanks.

好的，謝謝讓我提問。你們如何看待阿茲海默症第二期研究對路易體研究本身的「讀穿」效應？回到幾年前做過一項類似研究時，Pima 似乎在那裡顯示出相當強的訊號。所以不論阿茲海默症第二期結果如何，對於明年路易體適應症的去風險化，我們應該怎麼思考？謝謝。

I love that question and love what's baked into it. I agree that while it's in small numbers of patients, I've always found the data in pimavanserin and Lewy Body to be fairly striking. In that HARMONY study, just for people who are a little less familiar than you are, the withdrawl study, there were about 20 patients per arm with Lewy Body, and of those who had their treatment withdrawn, about 55% of them relapsed, and those who continued on, only about 5% did, so striking well in a small number of patients.

我很喜歡這個問題，也很喜歡它背後隱含的思考。我同意，雖然病人數不多，但我一直覺得 pimavanserin 在路易體方面的數據相當令人印象深刻。在 HARMONY 研究中——給一些可能不像你這麼熟悉的人說明一下，那是一個停藥（withdrawal）研究——路易體每組大約 20 位病人；在停用治療的那一組，大約 55% 復發，而持續用藥的那一組只有約 5% 復發，所以即使樣本數小，結果也非常顯著。

So that actually, to your point, regardless of how the ADP study turns out, and we do have high hopes for that based on all the things that I just talked through in the last few answers, but regardless, I think we remain very optimistic about the Lewy Body study.

所以其實如你所說，不論 ADP 研究結果如何——而且基於我在前幾個回答中提到的各項因素，我們對此抱持很高的期待——但無論如何，我認為我們對路易體研究仍然非常樂觀。

I think the one thing that could be a read-through would be something significant from a safety perspective. I'm not currently anticipating that, but obviously, we only know that when we get the data at the end of it. Thus far, though, we're optimistic about Alzheimer's, but regardless of that, I think we're very optimistic about Lewy body.

我認為可能會有「讀穿」效應的一點，是在安全性面向出現某些重大的訊號。我目前並不預期會發生，但當然，只有在研究結束拿到數據時我們才會知道。不過到目前為止，我們對阿茲海默症感到樂觀；但不管怎樣，我認為我們對路易體也非常樂觀。

Can we talk a little bit about how we think the formulation of Remli might suit the Lewy body patient as well in terms of their fragility and the different?

我們能不能談一下，我們認為 Remli 的劑型在路易體病人身上可能如何適配，特別是就他們的脆弱性以及不同的——？

So we do think that, obviously, the Lewy body patient population, both of these patient populations, obviously, are complex and with significant needs. Lewy body, generally speaking, is, I think, accepted to be a little bit more frail, and we think it is even more important to have something that is very safe and something that is very easy to take, which, again, has been something we've really prioritized with Remlifanserin.

所以我們確實認為，顯然路易體病人族群——其實這兩個病人族群——都很複雜且需求很高。一般來說，路易體被認為更為虛弱一些；因此我們認為更重要的是要有一個非常安全、而且非常容易服用的產品，而這也一直是我們在 Remlifanserin 上高度優先考量的重點。

Thanks, Liz. We're looking forward to seeing you next week (inaudible).

謝謝你，Liz。我們期待下週見到你（聽不清）。

Marc Goodman, Leerink.

Marc Goodman，Leerink。

Yeah, my question is on NUPLAZID. And if we had a delay in patients that you know are kind of getting on therapy, but they were delayed from January and part of February, why would we not have a great second quarter that kind of makes up for that, low first quarter because your guidance is kind of all this back-end loaded discussion. So I think you understand the question. Thank you.

是的，我的問題是關於 NUPLAZID。如果我們在病人開始用藥方面出現延遲——你們知道有些病人原本要開始治療，但從一月到二月上旬被延後——那為什麼第二季不會非常強、把第一季偏低的部分補回來？因為你們的財測指引看起來是在談很多「下半年偏重」的情境。所以我想你們理解我的問題。謝謝。

Yes, so let me kind of address that initially. I think we are expecting a strong second quarter, Marc. The dynamics that Tom referred to are definitely showing that from the current sales force. When we talk about the back end of the year, it's really the impact of the additional expansion.

好的，讓我先初步回應一下。Marc，我們確實預期第二季會很強。Tom 提到的那些動態，從目前的銷售團隊表現來看，確實顯示出這一點。當我們談到今年下半年時，主要是額外擴編所帶來的影響。

But let me just hand it over to Tom to sort of talk you through those specifically.

不過我先把問題交給 Tom，讓他更具體地帶你走過這些細節。

Absolutely. So thanks for the question, Marc. So as a reminder, we executed the 30% expansion of our sales team in Q1. That team has been in the field for now around kind of six weeks by the time we got to the end of the quarter. So we're really not seeing the full quarter impact of the productivity ramp that we anticipate seeing.

當然。Marc，謝謝你的提問。提醒一下，我們在第一季完成了銷售團隊 30% 的擴編。到季末為止，那支團隊在外勤大約才六週左右。因此我們其實還沒有看到我們預期的生產力爬坡所帶來的完整季度影響。

You are correct, we saw a very nice increase in referral volumes, 11% year over year, we saw good demand growth. But we did have this issue just in terms of late returning patients through the quarter, which was kind of further impacted by the normal Q1 dynamics you would expect to see for a Medicare population.

你說得沒錯，我們看到轉介量年增 11%，增幅相當不錯，也看到良好的需求成長。但在本季，我們確實遇到病人回流較晚的問題；此外，對於 Medicare 族群而言，這也受到第一季常見動態的進一步影響。

So moving forward, we anticipate that the productivity ramp will continue to impact us moving into the second quarter and beyond. We're continuing to push on the DTC efforts that I mentioned, both in terms of our unbranded, more to Parkinson's and branded efforts.

展望未來，我們預期生產力爬坡將會在第二季及之後持續對我們產生影響。我們也會持續推進我提到的 DTC（直接面向消費者）行銷，包含未掛品牌、較偏向帕金森氏症的推廣，以及掛品牌的推廣。

And in addition to that, all of the additional work that we're putting into place just around the expanded target universe that we're now going after, as a reminder, we've now increased our target universe to just over 10,000 HCPs.

除此之外，我們也在針對目前擴大的目標客群投入更多工作；提醒一下，我們現在已將目標醫療照護專業人員（HCPs）擴大到略高於 10,000 人。

We believe that tackling that is going to lead to significant uptick for the brands more broadly because we still have plenty of share growth that we can continue to drive over the coming quarters.

我們相信，攻克這個目標客群將會帶動品牌更廣泛的顯著上升，因為在接下來幾個季度，我們仍有很大的市占成長空間可以持續推動。

In terms of the question, just with guidance, I don't know if my.

就你關於指引的問題，我不確定我的——

The one thing I'd add, thanks for that, Tom, just from a financial perspective, it's more late to refill of existing patients, not new patients. So, those patients that were late to refill essentially missed a script in the year, so it's kind of a lost revenue.

我想補充一點——謝謝你，Tom——從財務角度來看，主要是既有病人的回補領藥（refill）延後，而不是新病人。因此，那些延後回補的病人等於在一年中少了一張處方，這部分有點像是流失的營收。

The good thing, though, is it's not a lost patient. Those patients have come back based upon our historical numbers and have refilled in the quarter. So, the positions are strong going forward, but not necessarily just a rebound of recouping what was missed in January and early February.

不過好消息是，這不是流失病人。根據我們的歷史數據，那些病人已經回來並在本季完成回補領藥。所以，往後的基本盤很強，但不一定只是單純反彈、把一月和二月上旬錯過的部分完全補回來。

Jack Allen, Baird.

Jack Allen，Baird。

Great, thanks so much for taking the questions and congrats on the progress. Just two quick ones from us on (inaudible) in the ADP study, this is a placebo-controlled study and the FDA has started to put out a lot of guidance around potentially allowing for filings on single trials. I just wanted to hear any thoughts you had on the potential to file on positive results in a placebo-controlled setting for (inaudible).

很好，謝謝讓我提問，也恭喜你們的進展。我們這邊有兩個很快的問題，關於（聽不清）在 ADP 研究中，這是一項安慰劑對照研究，而 FDA 也開始釋出不少指引，提到可能允許以單一試驗結果來申請送件。我想聽聽你們對於在安慰劑對照情境下，若結果為正，是否有可能據此申請送件的看法，針對（聽不清）。

And then briefly on day view, it seems like you're making a lot of progress with the fixed formulation and you have thrown out the $700 million and aspirational sales number for 2027 longer-term guidance there. I'm curious to what extent you factor in gene therapy into that longer-term guidance as well.

接著簡要談一下 DAYBUE 的固定劑型進展，看起來你們在固定劑型方面取得了很大進展，而且你們也提出了 2027 年較長期指引中 7 億美元的目標性銷售數字。我想了解的是，在這個較長期指引中，你們在多大程度上也把基因治療納入考量？

Do you want to take us off, Liz?

Liz，要不要由你來接續回答？

Sure. So great question about the single trial. And obviously we've had lots of discussions about this. What it's saying is, thus far, I think we're all still waiting for a guidance document around this to have a better understanding of the thought process. It's not clear some of the things which I anticipate will likely still apply, things like the size of the safety database.

好的。關於單一試驗的問題問得很好。顯然我們已就此進行了很多討論。目前它所傳達的是，到目前為止，我想我們都還在等待相關的指引文件，以便更好地理解其背後的思考邏輯。有些我預期仍可能適用的事項目前並不明確，例如安全性資料庫的規模。

And those are the types of considerations that make it such that my current expectation is that our base case assumption, which is that we need our Phase 2 and we need two Phase 3, is going to be what we're going to need at the end of the day. I do want to note that, obviously, if we were to see really striking results in this trial, we certainly would go have a conversation with FDA to explore what possibilities exist.

而這些類型的考量，使得我目前的預期是：我們的基本情境假設——也就是需要完成第二期，並且需要兩個第三期——最終仍會是我們所需要的。我也想補充，當然，如果我們在這項試驗中看到非常顯著的結果，我們一定會與 FDA 進行溝通，探討有哪些可能性。

But right now, again, our base case assumption is that we're going to need more than this single study, just purely based on the size of exposure that we would have.

但就目前而言，同樣地，我們的基本情境假設是：我們需要的不會只有這一項研究，純粹是基於我們將會有的暴露人數規模。

And just a top-line basis, I think we continue to be very confident in our $700 billion guidance for 2028. We have, of course, thought about competitive dynamics through that period, including gene therapy.

另外就整體而言，我認為我們仍然對 2028 年 7,000 億美元的指引非常有信心。當然，我們也已經思考過在那段期間的競爭動態，包括基因治療。

Tom, do you want to add anything else that the team's been thinking through?

Tom，你要不要補充一下團隊還在思考哪些面向？

Yes, absolutely. So, again, very pleased with the initial progress that we've seen with STIX. Obviously, this is complementing what we've already been driving over the last year with Liquid as well as we continue to expand into the community.

是的，當然。所以，再次強調，我們對 STIX 目前看到的初步進展非常滿意。顯然，這也在補強我們過去一年在 Liquid 方面所推動的成果，同時我們也持續擴展到社區端。

I think it's worth reminding everyone that our penetration for DAYBUE across the COEs and community physicians is still in like the 40% mark. So we've still got significant headroom for growth for this brand. And we believe with STIX, we can capture both naive and restart patients who may have stopped. And as a reminder, we have around 1,000 patients who have tried DAYBUE but are no longer continuing treatment. We believe that we're going to be able to re-engage those. We've seen that through the first quarter.

我覺得值得提醒大家的是，DAYBUE 在 COE（卓越中心）以及社區醫師端的滲透率目前仍大約在 40% 左右。因此這個品牌仍有相當大的成長空間。我們相信透過 STIX，我們可以同時抓住初治（naive）患者以及曾停止治療、可能重新開始的患者。另外提醒一下，我們大約有 1,000 名患者曾嘗試過 DAYBUE，但目前已不再持續治療。我們相信我們能夠重新與這些患者建立連結。我們在第一季已經看到這樣的趨勢。

As it relates to gene therapy, as we mentioned on the call, we've also been very pleased to see the Delphi consensus published, which clearly positions DAYBUE as standard of care for patients living with Rett syndrome.

至於基因治療，如同我們在電話會議中提到的，我們也很高興看到 Delphi 共識已發表，並且清楚地將 DAYBUE 定位為雷特氏症患者的標準治療（standard of care）。

Our view is that I think it will be good news to have more treatments available for the Rett disease, for the Rett syndrome population. I think we have to wait and see what the data actually tells us as the gene therapies come to floor, and we're going to be interested to see how that plays out.

我們的看法是，若雷特氏症、雷特氏症候群族群能有更多可用的治療方式，這會是好消息。我想我們必須等待並觀察，當基因治療逐步推進時，實際數據會告訴我們什麼；我們也會很關注後續的發展。

But irrespective, we believe that DAYBUE will have a role to play across all of these patients moving forward, whether gene therapies exist or not. So, again, as Catherine said, we feel really good about the $700 million that we've stated by 2028.

但無論如何，我們相信 DAYBUE 未來在所有這些患者中都會扮演一定角色，不論是否存在基因治療。所以再次呼應 Catherine 的說法，我們對於到 2028 年達到 7 億美元的目標感到非常有信心。

Ami Fadia, Needham.

Needham 的 Ami Fadia。

Hi, good afternoon. Thanks for taking my question. And my question is on (inaudible) with regards to the powering of the study, I think you mentioned that you're looking for a 0.4-point change. What is the minimum effect size that you need to see for the study to be statistically significant? And then as we also are expecting data from Cobenfy to study where they'll be looking at the endpoint of NPIC.

嗨，午安。謝謝讓我提問。我的問題是關於（聽不清）以及研究的檢定力（powering）。我想你們提到你們在尋找 0.4 分的變化。那麼，這項研究要達到統計顯著性，所需的最小效應量是多少？另外，我們也預期 Cobenfy 的研究會有數據，他們將觀察 NPIC 這個終點。

When you give us the top-line data readout, would you be providing NPIC data? And at what time point is that being measured? Just trying to get a sense of how will we compare data across trials just to sort of understand the competitive profile for this product when the data is out. Thank you.

當你們提供主要（top-line）數據讀出時，會提供 NPIC 的數據嗎？NPIC 是在什麼時間點測量的？我只是想了解，未來數據出來後，我們要如何在不同試驗間比較數據，以便理解這個產品的競爭輪廓。謝謝。

Well, I always feel like I need to start with a, you need to be careful in cross-study comparisons. But in seriousness in this case, I think an important thing that I should note is that NPIC was an addition to our study after it had gotten started. It was actually one of the earlier things that I did in my tenure here.

我總覺得我需要先提醒一句：跨試驗比較要小心。但就這個案例而言，我認為我需要指出的一個重點是：NPIC 是在我們的研究開始之後才新增進來的。其實那是我到任後做的較早期事項之一。

And accordingly, we will not have NPIC data on all patients who are participating in the Alzheimer's study. So we think that this is going to be important in the Phase 2 Alzheimer's study. Sorry, I should be clear there. We think this is going to be important information, but I don't know that I would anticipate it would be, for example, part of a top-line result. It is an exploratory endpoint with a subset of patients.

因此，我們不會在所有參與阿茲海默症研究的患者身上都有 NPIC 數據。所以我們認為這在第二期阿茲海默症研究中會很重要。抱歉，我應該把這點說清楚。我們認為這會是重要資訊，但我不確定我會預期它例如會成為主要結果（top-line result）的一部分。它是一個探索性終點，且只涵蓋一部分患者。

In terms of powering expectations, so we are powered at 80% for an effect size of 0.4. So you can imagine there's a little bit of flex around that with scenarios that could still be statistically significant, but that's generally what we're looking for.

至於檢定力的預期，我們以 80% 的檢定力來設計，對應的效應量是 0.4。因此你可以想像，圍繞這個數值會有一些彈性，在某些情境下仍可能達到統計顯著性，但大致上我們就是在尋找這樣的效果。

Thanks, Ami.

謝謝你，Ami。

Sean Laaman, Morgan Stanley.

Morgan Stanley 的 Sean Laaman。

Hi, good afternoon. This is Catherine on for Sean. Thank you so much for taking our question. We had another one on DAYBUE STIX. As adoption scales, can you just provide some color if you expect any meaningful change in persistency versus the liquid formulation, or is the primary benefit improved front-end initiation and reduced early friction?

嗨，午安。我是代替 Sean 的 Catherine。非常感謝讓我們提問。我們還有一個關於 DAYBUE STIX 的問題。隨著採用規模擴大，你們能否分享一下，你們是否預期相較於液體劑型，治療持續性（persistency）會有任何顯著變化？還是主要效益在於改善前端啟動、降低早期摩擦？

And just as a quick follow-up, I think you mentioned about 1,000 patients have previously tried DAYBUE. Can you share more about your strategy to re-engage these patients? Thanks so much.

另外快速追問一下，我想你們提到大約有 1,000 名患者之前曾嘗試過 DAYBUE。你們能否分享更多重新接觸並讓這些患者回流的策略？非常感謝。

Absolutely. So let me tell you that for you, Catherine. So starting with persistency, what I would say is we are monitoring this very closely because as you would imagine, if we can improve persistency further over and above what we're seeing with liquid, obviously that would be very advantageous for us.

當然可以。那我來跟你說明一下，Catherine。先從治療持續性談起，我會說我們正在非常密切地監測，因為如你所想，如果我們能在液體劑型的基礎上進一步提升持續性，這對我們顯然會非常有利。

Just as a reminder, in terms of the latest data that we have, just regarding consistency with the liquid formulation, at 12 months, we are now north of 55% remaining on treatment through 12 months. We're retaining about 50% of patients through 18 months.

提醒一下，就我們目前最新的數據而言，關於與液體劑型的一致性，在 12 個月時，目前仍在治療中的比例已超過 55%。在 18 個月時，我們大約能保留 50% 的患者持續治療。

So persistency for liquid actually continues to improve overtime. And the latest data we have is that 74% of our active patients have actually been on treatment for 12 months or longer. So we continue to be pleased with just the growing group of like persistent patients who are continuing to seek benefit with DAYBUE.

因此，液體劑型的治療持續性實際上會隨著時間持續改善。而我們掌握的最新數據顯示，74%的活躍患者實際上已接受治療達12個月或更久。因此，我們仍然很高興看到這一群持續用藥的患者不斷擴大，他們持續從DAYBUE中尋求獲益。

STIX, to your question, we believe it can help in terms of initial friction. Obviously, there is some significant advantages that we believe exist that go beyond the liquid formulation. But as it stands at the moment, it's probably too early to be definitive as to how STIX will perform in the real world in comparison to liquid, but we will be sharing more detail in due course.

關於STIX，針對你的問題，我們認為它在降低初期摩擦方面會有所幫助。顯然，我們相信除了液體劑型之外，還存在一些顯著優勢。但就目前而言，現在要對STIX在真實世界相較於液體劑型的表現下定論可能還為時過早，不過我們會在適當時機分享更多細節。

Do you want to talk to the 1,000 patients and how many of those we think might be up for grabs?

你想談談那1,000名患者，以及其中有多少我們認為可能有機會爭取到嗎？

Yeah, absolutely. So, as you think about the 450 patients that we spoke about earlier on in the year, and you can kind of break that down. We think that roughly three-quarters of those would be naive to treatment and the remaining quarter would be restarts. If you look at what we're seeing so far through Q1, it's roughly a 50, 50 split of that 30%.

是的，當然。因此，當你思考我們今年稍早提到的450名患者時，你可以大致拆解一下。我們認為其中約四分之三是治療新手（先前未接受治療），其餘四分之一則是重新開始治療的患者。如果看我們截至第一季目前所看到的情況，在那30%之中大約是50/50的分布。

Now, we're seeing both naive, we're also seeing returning patients, but as I mentioned on the call, we're also seeing significant interest from existing patients receiving the liquid formulation in switching to STIX. So taken together, that's where we are.

目前我們同時看到治療新手，也看到回流患者；但如我在電話會議中提到的，我們也看到既有使用液體劑型的患者對於轉換到STIX有相當大的興趣。綜合來看，現況就是如此。

And just to close this one, the momentum that we saw in Q1 actually has continued into Q2 as we've gone broader into the community. So again, excited to share more details in due course, but we're very pleased with the initial uptake of STIX.

最後補充一下，我們在第一季看到的動能，隨著我們更廣泛地深入社區，在第二季也確實延續下來。因此，我們會在適當時機再分享更多細節，但我們對STIX的初期採用情況感到非常滿意。

I think Q2 will be a much more descriptive story about STIX and the types of patients we're seeing. So we look forward to sharing more then. Catherine, thanks for the question.

我認為第二季會更能具體描述STIX的故事，以及我們所看到的患者類型。所以我們期待到時再分享更多。Catherine，謝謝你的提問。

Evan Segerman, BMO.

Evan Segerman，BMO。

Hi, Mark Hoffman on for Evan. Thanks for taking our question. Asking about the STIX again, just wanted to see if there was any specific stocking for the STIX formulation this quarter. And then also, I want to get a sense of how you can ensure patients proceed with refills for the STIX formulation to kind of continue the strong momentum we've seen in this quarter. Appreciate it.

嗨，我是代Evan提問的Mark Hoffman。謝謝讓我們提問。再問一次關於STIX，我想了解本季是否有任何針對STIX劑型的特定備貨安排。另外，我也想了解你們如何確保患者會持續進行STIX劑型的續配，以延續我們在本季看到的強勁動能。謝謝。

Perfect. Yeah, I have to say that, Hoffman. So, first question in terms of stocking. What I would say is very similarly to what we see with liquid. We supply everything through a single specialty pharmacy and it really is on a patient-by-patient basis.

很好。是的，我得說，Hoffman。先回答備貨的問題。我會說這和我們在液體劑型上看到的情況非常類似。我們透過單一的專科藥局供應所有產品，基本上是以每位患者為單位來處理。

So there is very limited stocking that we are anticipating or have seen. And then in terms of refills, as I mentioned, of the 250 prescriptions that we actually had in the quarter, over 220 were actually filled. So we're not seeing any issues as it relates to payers or formulary issues on the whole. We're actually seeing it, things to be very smooth and in line with our expectations, which again is a nice proof point that the strategy that we've employed here in terms of a limited launch has worked well for us.

因此，我們預期或目前看到的備貨量都非常有限。至於續配，如我提到的，本季我們實際開出的250張處方中，有超過220張已完成配藥。因此，整體而言，我們沒有看到與付款方或處方集（formulary）相關的問題。我們實際上看到流程非常順暢，且符合我們的預期；這也再次證明我們在此採取的有限度上市策略運作良好。

Thanks, Hoffman.

謝謝，Hoffman。

Rudy Li, Wolfe Research.

Rudy Li，Wolfe Research。

Hey, thanks for taking my question. Just a quick follow-up for [LDB12]. So how would these two endpoints being measured in the ADP trial help inform the benefits in LBDP, which is measuring a different endpoint of SAP's LBDP, and to what extent do their components or that? Thanks.

嗨，謝謝讓我提問。針對[LDB12]做個簡短追問。那麼，在ADP試驗中衡量這兩個終點，將如何幫助我們理解LBDP中的效益（其衡量的是不同的終點，即SAPS的LBDP），以及它們的組成部分在多大程度上彼此相關或重疊？謝謝。

I think it was a little bit difficult to hear some of that, Rudy, but I think it was to do with the different measurements of endpoints in ADP and LBD and [tau] versus maybe the alpha-synuclein view of the biomarker.

Rudy，有一部分我聽得有點不清楚，但我理解你的問題是關於ADP與LBD中終點衡量方式的差異，以及生物標記物是看[tau]，還是可能以α-突觸核蛋白（alpha-synuclein）的角度來看。

Thank you. Thank you. I missed a bit of it. Appreciate it. So first off. I guess a couple of important things with respect to the biomarker considerations. There are a number of more established biomarkers at this point that are considered to support the Alzheimer's diagnosis and we are actually requiring a biomarker confirmation of the diagnosis for entry into Alzheimer's. The Lewy body field is in a much more exploratory phase and so we are including an assessment of alpha-synuclein but it's not a requirement to get into the trial. It's a thing that we think is going to help inform us in terms of potential future trial design and also hopefully contributing to the science.

謝謝。謝謝。我漏聽了一點。感謝你的提問。首先。就生物標記物的考量而言，有幾個重要點。目前已有多種較為成熟、可用來支持阿茲海默症診斷的生物標記物，而我們實際上要求受試者在進入阿茲海默症試驗前需有生物標記物確認診斷。路易氏體領域仍處於更探索性的階段，因此我們會納入α-突觸核蛋白的評估，但它不是進入試驗的必要條件。我們認為這將有助於我們在未來試驗設計上獲得資訊，也希望能對科學研究有所貢獻。

In terms of the endpoints, there is a fair amount of overlap between the SAPS H&B and the SAPS Lewy body. They are both derived from the overall SAPS scale and are a similar but not exactly the same subset of attributes.

就終點而言，SAPS H&B與SAPS路易氏體之間有相當程度的重疊。兩者都源自整體SAPS量表，屬性子集相似，但並非完全相同。

The SAPS Lewi Body in particular was based on those aspects that we saw in the PDP and the kind of answering PDP trial that seemed to be most impacted. So that was the driver beyond that, but a lot of overlap between those two endpoints.

特別是SAPS路易氏體，是基於我們在PDP以及所謂的「answering PDP」試驗中觀察到、似乎受影響最明顯的那些面向所建立。因此這是其背後的驅動因素，但這兩個終點之間確實有大量重疊。

Thanks, Rudy.

謝謝，Rudy。

David Hoang, Deutsche Bank.

David Hoang，德意志銀行。

Hey, this is Sam on for David. Thanks for taking the question. Back to DAYBUE. Is there anything else that you're able to share on the prescribing penetration dynamics in the quarter as it relates to the community setting for Centers of Excellence?

嗨，我是代David提問的Sam。謝謝讓我提問。回到DAYBUE。就本季在社區端相對於卓越中心（Centers of Excellence）的處方滲透動態，你們還能分享其他資訊嗎？

And as a follow-up, noting that the STIX formulation was initially launched in Centers of Excellence. How should we be thinking about the impact of that formulation in terms of how you think it would resonate and drive prescribing in the community through the rest of the year and the future? Thanks.

另外追問，鑑於STIX劑型最初是在卓越中心推出。我們應該如何看待該劑型的影響——就你們認為它在今年剩餘時間及未來，將如何在社區端引起共鳴並帶動處方而言？謝謝。

Absolutely. So I have to take that question, Sam. So as you would imagine, given our strategy for DAYBUE STIX is really focused on COEs at launch. We did actually see, A, an increase in terms of the number of prescriptions or the overall volume of prescriptions that was coming from COEs in the quarter, so I think we were roughly 79% was coming from the community in the quarter from the COE versus a lower number from the community.

當然。Sam，這題我來回答。如你所料，鑑於我們對DAYBUE STIX的策略在上市初期確實聚焦於COE（卓越中心）。我們在本季確實看到：A，就來自COE的處方數量或整體處方量有所增加；因此我想本季大約有79%是來自COE，而來自社區的比例則較低。

And I think that, again, that's just reflected in the fact that there's been this significant excitement amongst the community around STIX. As you think about kind of the penetration that we have, which again, we've spoken about in the past, we still have significant opportunities. So our penetration within (inaudible), even with STIX, is around 60%, our penetration in the community currently sits at around 28% before the launch of STIX.

而我認為這也再次反映出社群對STIX有相當高的興奮度。當你思考我們目前的滲透率——我們過去也談過——我們仍有很大的機會空間。因此，我們在（聽不清楚）內的滲透率，即使加上STIX，也大約是60%；而在STIX上市前，我們在社區端的滲透率目前約為28%。

Of note, both of those have grown significantly over the last year. Most importantly, though, our penetration within the community, which is a reminder is about 65% of the overall available volume has grown by about 7% on an actual basis over the last year. So again, I think a nice proof point that the strategy that we've employed to kind of focus on COEs but expand our reach into the community and STIX is very much going to be a part of our strategic roadmap there is working for us, and that's what's giving us real confidence in the outlook for DAYBUE for this year and moving forward.

值得注意的是，這兩項在過去一年都大幅成長。不過最重要的是，我們在社區端的滲透率——提醒一下，社區端約占整體可取得量的 65%——在過去一年按實際基礎計算提升了約 7%。因此再次說明，我認為這是一個很好的佐證：我們所採取的策略，一方面聚焦 COE（卓越中心），另一方面擴大我們在社區與 STIX 的觸及範圍，確實會是我們策略路線圖的一部分，而且正在發揮效果；這也讓我們對 DAYBUE 今年及未來的展望充滿信心。

Yatin Suneja, Guggenheim.

Yatin Suneja，Guggenheim。

Hey, guys. Thank you for taking my question. Just a quick one on the re-examination process happening in Europe, could you just talk about where you are? What do you expect to learn from the process there on Phenotype? Thank you.

嗨，各位。謝謝讓我提問。關於歐洲正在進行的重新審查流程，我想簡單問一下，你們目前進展到哪裡？你們預期會從那邊針對 Phenotype 的流程中學到什麼？謝謝。

So the re-examination process, there are a few points along the way. There is your original intent to request re-examination. We did that very shortly upon receiving the original negative opinion. There's submission for, there's assignment of new rapporteurs, which has occurred. There is, excuse me, my voice is going today. There is submission of the grounds for re-examination, which we have completed. We anticipate an upcoming SAG meeting, and then there may or may not be an oral examination meeting. So we are just past the submission of our grounds for re-examination.

關於重新審查流程，途中有幾個節點。首先是你們最初提出申請重新審查的意向。我們在收到原先的否定意見後不久就提出了。接著是指派新的報告員（rapporteurs），這已經完成。不好意思，我今天嗓子有點不舒服。然後是提交重新審查的理由（grounds for re-examination），我們也已完成。我們預期接下來會有一場 SAG 會議，之後可能會、也可能不會有口頭審查會議。所以我們目前剛過了提交重新審查理由的階段。

Thanks, Liz.

謝謝，Liz。

Paul Matisse, Stifel.

Paul Matisse，Stifel。

Hey there, this is Julian on for Paul. Thanks very much for taking our questions. Really quickly on DD, just curious if anything has changed and, how you may be prioritizing external innovation versus internal, especially with the announcement disclosed last week, elsewhere, also just curious on.

嗨，我是代替 Paul 的 Julian。非常感謝讓我們提問。很快問一下 BD（商務開發），想了解是否有任何變化，以及你們如何在外部創新與內部創新之間做優先排序，尤其是考量到上週在其他地方披露的公告；另外也想問一下。

Do you plan on disclosing total number of shipments at all moving forward? I know it's something that you disclosed in 4Q, and I know you said there was a record number of this year, but just wanted clarification on that. Thank you.

你們未來是否會披露出貨總量？我知道你們在第四季曾披露過，也知道你們說今年出貨量創新高，但想確認一下。謝謝。

Let's get the team a rest from answering, give Liz's worth the rest and tackle both of those. So in terms of BD, as we've stated, we remain very active and focused on our BD strategy. As you pointed out, we do have a very rich internal pipeline and our late stage is certainly looking great in the next two years. But obviously, we're managing business for the longer-term and we're really focused on kind of two areas really right now.

讓團隊稍微休息一下別一直回答，讓 Liz 也喘口氣，我來回答這兩個問題。就 BD 而言，如同我們所說，我們仍然非常積極並專注於 BD 策略。如你所指出，我們內部的產品線非常豐富，且未來兩年我們的後期階段看起來確實很不錯。但顯然，我們是在為更長期經營公司，因此目前我們主要聚焦在兩個領域。

One is later stage assets that we could bolt onto our current commercial franchise, which Tom is leading with such great success and so we're looking there. But we're also looking at continuing to refresh our early-stage pipeline, which Liz and her team are managing. So those are kind of our two main areas of focus right now.

第一是後期資產，我們可以把它們加掛到現有的商業化事業上；Tom 正以非常成功的方式領導這一塊，所以我們在那裡尋找機會。但我們也在持續更新我們的早期產品線，這部分由 Liz 和她的團隊負責。所以這就是我們目前兩個主要的聚焦方向。

We have a lot of ability to flex with our balance sheet, and we know that it's a very competitive process. We are actively involved in processes, and we continue to look for the right fit for ACADIA . We're not under any particular pressure right now, but we are looking for strong fits for our business moving forward to drive that long-term value and growth for our shareholders, but also, more importantly, the patient That we aim to serve.

我們的資產負債表具備很大的彈性空間，也知道這是一個競爭非常激烈的流程。我們正積極參與相關流程，並持續尋找最適合 ACADIA 的標的。我們目前沒有任何特定壓力，但我們正在尋找能與我們業務高度契合的機會，以在未來為股東創造長期價值與成長；同時更重要的是，為我們希望服務的病患帶來效益。

In terms of the shipping, we did commit to kind of moving now towards financial dollar top-line. We feel after three years of launch that sort of specific patient-level metrics on shipping for debut is probably not the right way to assess the brand.

至於出貨方面，我們確實承諾接下來會更偏向以財務金額的營收（top-line）來呈現。我們認為在上市三年後，以 DAYBUE 的特定病患層級出貨指標來評估品牌，可能不是最合適的方式。

We will continue to give clarity like Tom has stay on the STIX dynamic, so you can see that playing forward. But in terms of patient shipped, we're not going to be sharing that anymore, but it just does continue to grow and we're very confident again in our full-year forecast for both brands. And thank you for the question.

我們會持續提供清楚的資訊，例如 Tom 一直在說明 STIX 的動態，讓你們可以看到後續的發展。但就病患出貨數而言，我們將不再分享；不過它確實仍在持續成長，我們也再次對兩個品牌的全年預測非常有信心。也謝謝你的提問。

Ladies and gentlemen, that does conclude our question-and-answer session. And I would now like to turn the conference back over to Catherine Owen-Adams for closing comments.

各位女士先生，我們的問答環節到此結束。接下來我想把電話會議交回給 Catherine Owen-Adams 作結語。

I'd just like to thank everybody for their great questions today and the team here for answering them, and specifically Liz for all the great answers on Remlifanserin answering. We're very excited about the next few quarters for ACADIA, both with our commercial brands, but also, obviously, the top-line results of Remlifanserin. And we look forward to continuing to discussing with you and to our conferences in the next coming weeks. Thanks again for your interest in ACADIA today.

我想感謝大家今天提出的精彩問題，也感謝在座團隊的回答，特別是 Liz 對 Remlifanserin 的所有精彩回覆。我們對 ACADIA 接下來幾個季度感到非常振奮，無論是我們的商業化品牌，當然也包括 Remlifanserin 的主要結果（top-line results）。我們期待在未來幾週持續與各位交流，也期待在接下來的會議上再與各位討論。再次感謝大家今天對 ACADIA 的關注。

Ladies and gentlemen, this does conclude today's conference call. Thank you for your participation, and you may now disconnect.

各位女士先生，今天的電話會議到此結束。感謝各位的參與，現在可以掛線。