ACADIA Pharmaceuticals Inc (ACAD) 2025 Q3 法說會逐字稿

Good day, ladies and gentlemen, and thank you for standing by. Welcome to ACADIA Pharmaceuticals' third-quarter 2025 financial results conference call. (Operator Instructions)

各位女士、先生，大家好，感謝你們的耐心等待。歡迎參加 ACADIA Pharmaceuticals 2025 年第三季財務業績電話會議。（操作說明）

Please be advised that today's conference is being recorded.

請注意，今天的會議正在錄影。

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

現在我謹將會議交給 ACADIA 投資人關係和企業傳播資深副總裁 Al Kildani。請繼續。

Good afternoon and thank you for joining us on today's call to discuss ACADIA's third-quarter 2025 financial results. 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 brand, DAYBUE and 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.

下午好，感謝各位參加今天的電話會議，共同討論 ACADIA 2025 年第三季的財務表現。今天與我一同參加電話會議的還有 ACADIA 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。今天與我們一同出席的還有執行副總裁兼研發主管伊麗莎白·湯普森博士，她將介紹我們的研發管線項目的最新進展；以及我們的首席財務官馬克·施奈爾，他將回顧財務亮點。接下來，凱瑟琳將作總結發言，之後我們將開放提問環節。

We are using supplemental slides which are available on our website's Events and Presentations section.

我們使用了補充幻燈片，這些幻燈片可在我們網站的「活動和簡報」部分找到。

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, assumption, and expectations that are inherently subject to change and involves 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，我們將根據 1995 年《私人證券訴訟改革法案》的定義做出若干前瞻性陳述。這些前瞻性陳述，包括目標、預期、計劃、前景、成長潛力、事件發生時間、未來業績和財務指導，均基於當前資訊、假設和預期，而這些資訊、假設和預期本身就容易發生變化，並且涉及若干風險和不確定性，可能導致實際結果與預期有重大差異。

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

這些因素以及與我們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。

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.

請注意，您不應過度依賴這些前瞻性陳述，這些陳述僅代表截至今日的觀點，除法律要求外，我們不承擔因情況變化而更新或修改這些前瞻性陳述的義務。

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

現在我將把電話交給凱瑟琳，請她致開幕詞。

Thank you, Al. Good afternoon, everyone, and thank you for joining us today. I'm pleased to report another strong quarter for ACADIA with solid execution across our commercial portfolio and continued momentum, positions us well for a strong finish to 2025 as we laid the foundation for sustained growth in 2026 and beyond.

謝謝你，阿爾。各位下午好，感謝各位今天參加我們的節目。我很高興地報告，ACADIA 又迎來了一個強勁的季度，我們在商業組合方面執行穩健，並保持了持續的增長勢頭，這使我們能夠在 2025 年取得強勁的收官，並為 2026 年及以後的持續增長奠定了基礎。

We delivered total revenues of $278.6 million this quarter, up 11% from a year ago, reflecting the strength of our commercial portfolio. This performance underscores our ability to execute on multiple fronts while building for future growth.

本季我們實現了 2.786 億美元的總收入，比去年同期成長了 11%，這反映了我們商業產品組合的強勁表現。這項業績凸顯了我們在多個方面同時執行任務的能力，並為未來的成長奠定了基礎。

Starting with DAYBUE, we're very pleased with our progress. Following the expansion of our field force earlier this year, the benefits of which are now starting to materialize. I'm excited to share that we achieved our largest sequential increase in referrals that launch. This meaningful sequential growth reflects the impact of our expanded team into the community setting, giving us confidence that we will continue to see benefits from our broadened positional reach.

從 DAYBUE 開始，我們對所取得的進展非常滿意。今年早些時候，我們擴大了銷售隊伍，現在其帶來的好處開始顯現。我很高興地宣布，我們實現了推薦用戶數量連續增長的最大增幅。這一意義重大的持續成長反映了我們擴大的團隊對社區環境的影響，讓我們有信心繼續從我們擴大的職位影響力中受益。

During the third quarter, DAYBUE generated $101.1 million in net sales, including contributions from both US sales and then patient supply programs outside the US. We shipped the highest number of DAYBUE ever in a single quarter. In total, we've shipped for over 1,000 unique patients globally, an exciting milestone for the company. Importantly, patient persistency remains stable, underscoring the sustained benefit that DAYBUE delivers to patients and their families.

第三季度，DAYBUE 的淨銷售額為 1.011 億美元，其中包括美國銷售額以及美國以外患者供應計畫的貢獻。我們在單季內出貨了 DAYBUE 有史以來最多的產品。我們總共為全球超過 1000 名不同的患者提供了產品，這對該公司來說是一個令人興奮的里程碑。重要的是，患者的堅持治療率保持穩定，這凸顯了 DAYBUE 為患者及其家人帶來的持續益處。

Moving to NUPLAZID. We delivered an exceptional quarter with net sales of $177.5 million, marking our strongest sales quarter ever. The momentum we are now driving gives us tremendous confidence in NUPLAZID's potential to unlock higher growth in the coming years. To ensure we capture this opportunity, we're making strategic investments in a meaningful field force expansion. The impact of this field team expansion, combined with our direct-to-consumer campaigns, creates a powerful combination that we believe will drive sustained growth and value maximization for NUPLAZID.

遷移至 NUPLAZID。我們本季業績斐然，淨銷售額達 1.775 億美元，創下公司有史以來最佳銷售季紀錄。我們目前的發展勢頭讓我們對 NUPLAZID 在未來幾年釋放更高成長潛力充滿信心。為了確保我們抓住這一機遇，我們正在進行策略性投資，以大幅擴大銷售團隊。這次現場團隊擴張，加上我們的直接面向消費者的行銷活動，將形成強大的組合，我們相信這將推動 NUPLAZID 的持續成長和價值最大化。

We're looking to build on our commercial success by advancing our pipeline of novel product candidates, including the recent initiation of one Phase 2 and one Phase 3 trial.

我們希望透過推動新產品研發管線，鞏固我們的商業成功，包括最近啟動的一項 2 期臨床試驗和一項 3 期臨床試驗。

I'll now send the call over to Tom to cover our commercial performance.

我現在把電話轉給湯姆，請他來報告我們的商業演出狀況。

Thank you, Catherine. I'll begin with DAYBUE, where we delivered another strong quarter of commercial execution. DAYBUE sales were $101.1 million in Q3, representing our highest revenue and total prescription volume in any quarter to date since launch.

謝謝你，凱瑟琳。我先從 DAYBUE 開始，我們又實現了一個強勁的商業執行季度。DAYBUE 第三季銷售額為 1.011 億美元，創下自上市以來單季營收和處方總量的最高紀錄。

As Catherine noted, for the first time since approval, the number of unique patients receiving DAYBUE worldwide exceeded 1,000 in a single quarter, for an actual count of 1,006. This achievement reflects not only our progress in the US, but also from patients now starting to access DAYBUE through our main patient supply programs internationally.

正如凱瑟琳所指出的，自獲批以來，全球接受 DAYBUE 治療的獨立患者人數首次在一個季度內超過 1000 人，實際人數為 1006 人。這項成就不僅反映了我們在美國的進展，也反映了患者現在開始透過我們在國際上的主要患者供應計劃獲得 DAYBUE 的進展。

We're seeing strong early indicators from our field force expansion. Referrals are leading the way, with the highest quarter-over-quarter increase since DAYBUE's launch in 2023. This momentum is translating into other key performance indicators, such as broadening prescriber reach with 956 physicians having now written at least one prescription for DAYBUE.

我們從現場團隊擴張中看到了強勁的早期跡象。推薦量成長最為顯著，季度環比增幅為 DAYBUE 自 2023 年推出以來的最高水準。這種勢頭正在轉化為其他關鍵績效指標，例如擴大處方醫生的覆蓋範圍，目前已有 956 名醫生至少開過一張 DAYBUE 的處方。

Our sales teams are now gaining real traction, with call volumes on our expanded target customer base increasing over 20% versus Q2, supported by a similar increase in the number of educational programs we delivered, both of which are important levers in helping to educate prescribers on the benefits that DAYBUE has to offer.

我們的銷售團隊現在取得了真正的進展，與第二季度相比，我們擴大的目標客戶群的電話量增加了 20% 以上，同時我們提供的教育項目數量也相應增加，這兩者都是幫助教育處方醫生了解 DAYBUE 所能提供的益處的重要手段。

Importantly, adoption is broadening beyond Centers of Excellence or COEs with community-based positions accounting for 74% of new prescriptions in Q3. We're also seeing a meaningful uptick in scripts from nurse practitioners and physician assistants, reinforcing that strategy to expand in-person efforts into wider treating community is working. These trends position us well to reach more Rett patients who could benefit from DAYBUE.

重要的是，採用範圍正在擴大到卓越中心 (COE) 以外，社區職位在第三季度佔新處方的 74%。我們也看到執業護理師和醫師助理開出的處方數量顯著增加，這進一步證實了將面對面服務擴展到更廣泛的治療群體的策略是有效的。這些趨勢使我們能夠更好地接觸到更多可能從 DAYBUE 中受益的 Rett 患者。

Even with this progress, overall market penetration remains relatively low at about 40% in the US and only 27% in the community setting where the majority of Rett patients are treated. This continues to represent a substantial growth opportunity for the brand.

即使取得了這樣的進展，整體市場滲透率仍然相對較低，在美國約為 40%，而在大多數 Rett 患者接受治療的社區環境中，滲透率僅為 27%。這繼續為該品牌帶來巨大的成長機會。

Looking at age demographics, penetration among patients under the age of 11 is over 60% and amongst older patients is significantly lower despite growing real world evidence of DAYBUE's positive impact in this group. As we expand our reach beyond COEs, we see this segment as a significant growth driver for 2026 and beyond.

從年齡人口統計來看，11 歲以下患者的滲透率超過 60%，而老年患者的滲透率則明顯較低，儘管越來越多的現實證據表明 DAYBUE 對該群體產生了積極影響。隨著我們將業務拓展到 COE 以外的領域，我們認為這一領域將成為 2026 年及以後重要的成長動力。

Long-term persistency remains a key strength for DAYBUE, reflecting its sustained clinical benefit and strong patient engagement. With another quarter of maturity in our data, persistency rates remain above 50% for 12 months and greater than 45% at 18 months. The strength of these metrics are important as they further reinforce not only our confidence in DAYBUE's therapeutic value, but also our outlook for sustainable long-term growth in the US.

DAYBUE 的長期療效依然是其一大優勢，這體現了其持續的臨床益處和強大的患者參與度。隨著我們數據中又一個季度的到期日到來，12 個月的持續率保持在 50% 以上，18 個月的持續率保持在 45% 以上。這些指標的強度非常重要，因為它們不僅進一步增強了我們對 DAYBUE 治療價值的信心，也增強了我們對美國可持續長期成長的前景的信心。

Internationally, our main patient supply programs continue to gain traction. All three distribution partners are now actively shipping to patients in the EU, Israel, Middle East, and Latin America. Looking ahead, we remain confident in DAYBUE's growth outlook driven by sustained demand generation, supported by our strategic field force investments, strong persistency metrics, and expanding global access.

在國際上，我們的主要患者物資供應計畫持續取得進展。這三家分銷合作夥伴目前都在積極向歐盟、以色列、中東和拉丁美洲的患者出貨。展望未來，我們仍然對 DAYBUE 的成長前景充滿信心，這得益於持續的需求成長、策略性的現場團隊投資、強勁的客戶留存率以及不斷擴大的全球市場覆蓋。

These factors are critical because they are not only validate the long-term value of DAYBUE for patients, but also create a durable foundation for revenue growth. While we began to see the initial positive impact from the field force expansion in Q3, we expect meaningful benefits to accelerate through Q4 and into 2026.

這些因素至關重要，因為它們不僅驗證了 DAYBUE 對患者的長期價值，而且還為收入成長奠定了持久的基礎。雖然我們在第三季開始看到現場人員擴充的初步正面影響，但我們預計到第四季及2026年，顯著的效益將會加速顯現。

In summary, DAYBUE is well positioned to capture significant market opportunities in the US and internationally, reinforcing our commitment to delivering both patient impact and shareholder value.

總而言之，DAYBUE 已做好充分準備，抓住美國和國際市場的重要機遇，從而鞏固我們致力於為患者帶來積極影響並創造股東價值的承諾。

Now turning to NUPLAZID, where we delivered record performance with net sales of $177.5 million, representing 12% year-over-year growth driven by 9% volume growth. This reflects strong underlying demand for NUPLAZID among patients with Parkinson's disease, psychosis, or PDP, and the success of our commercial strategy coupled with the unwavering focus of our customer facing teams on executional excellence.

現在來看看 NUPLAZID，我們取得了創紀錄的業績，淨銷售額達到 1.775 億美元，年增 12%，其中銷量成長 9%。這反映了帕金森氏症、精神病或帕金森氏症患者對 NUPLAZID 的強勁潛在需求，以及我們商業策略的成功，再加上我們面向客戶的團隊對卓越執行的堅定不移的專注。

Referrals were a key driver of this momentum, increasing 21% year over year. This growth signals increasing awareness and confidence among healthcare providers in identifying and treating Parkinson's-related hallucinations and delusions earlier in the course of the disease.

轉診是推動這一成長動能的關鍵因素，年增 21%。這一增長表明，醫療保健提供者對在帕金森氏症早期識別和治療與帕金森氏症相關的幻覺和妄想的認識和信心不斷提高。

New prescription volumes grew 23% in Q3, compared to the same quarter last year, representing the strongest year-over-year increase since 2019 and were up 9% sequentially. This inflection point demonstrates that our patient engagement campaigns and HCP outreach are translating into tangible, prescribing behavior.

第三季新處方量年增 23%，這是自 2019 年以來最強勁的同比增長，環比增長 9%。這個轉折點表明，我們的患者參與活動和醫護人員推廣活動正在轉化為切實的處方行為。

It also underscores their belief in NUPLAZID's differentiated profile as the first-and-only FDA approved therapy for PDP with a well-established safety and efficacy record. Taken together, we believe these trends are an important leading indicator of future prescribing behavior and reinforce the strength of NUPLAZID in meeting a critical unmet medical need.

這也凸顯了他們對 NUPLAZID 獨特優勢的信心，NUPLAZID 是第一個也是唯一一個獲得 FDA 批准的 PDP 療法，具有良好的安全性和有效性記錄。綜上所述，我們認為這些趨勢是未來處方行為的重要領導指標，並鞏固了 NUPLAZID 在滿足關鍵未滿足醫療需求方面的優勢。

As a reminder, the US PDP market represents a significant opportunity. There are approximately 1 million Parkinson's patients with an estimated 50% experiencing hallucinations and delusions at some point during the course of the disease. This translates into a substantial number of patients who could benefit from NUPLAZID, underscoring the long runway for growth.

再次提醒大家，美國 PDP 市場蘊藏著巨大的機會。全球約有 100 萬名帕金森氏症患者，據估計其中 50% 的患者在病程中的某個階段會出現幻覺和妄想。這意味著有大量患者可以從 NUPLAZID 中受益，凸顯了其巨大的成長潛力。

Looking ahead, we see significant opportunity to build on this momentum. Our reach and frequency model is driving broader prescribing patterns across a wide range of ACPs and our direct consumer campaigns are raising awareness of PDP symptoms while highlighting NUPLAZID as the first and only approved treatment.

展望未來，我們看到了利用這一勢頭取得更大發展的巨大機會。我們的覆蓋率和頻率模型正在推動各種 ACP 的更廣泛的處方模式，而我們的直接消費者活動正在提高人們對 PDP 症狀的認識，同時強調 NUPLAZID 是第一個也是唯一一個獲批的治療方法。

To fully realize NUPLAZID's long-term potential and capitalize on the brand's strong momentum, we are making strategic investments, including a 30% increase in our customer-facing team starting in the first quarter of 2026.

為了充分發揮 NUPLAZID 的長期潛力並利用品牌的強勁勢頭，我們正在進行策略性投資，包括從 2026 年第一季開始將面向客戶的團隊增加 30%。

This expansion will allow us to reach newly activated positions and improve pull through. We're approaching this expansion thoughtfully to maximize near-term efficiency and long-term impact for various consumer initiatives are driving awareness and creating demand with our expanded field force, ensuring we efficiently convert that demand into prescription.

此次擴張將使我們能夠進入新活化的市場，並提高市場滲透率。我們正在深思熟慮地推動此次擴張，以最大限度地提高近期效率和長期影響，透過擴大銷售隊伍，各項消費者舉措正在提高公眾意識並創造需求，確保我們能夠有效地將這種需求轉化為處方。

In summary, the NUPLAZID fundamentals are strong. The markets opportunity is substantial, and we have a proven strategy designed to capture it. With the differentiated product profile, accelerating demand indicators and targeted investments in our commercial model, our ambition is not just to grow, but to become standard of care for these patients.

總而言之，NUPLAZID 的基本面很強勁。市場機會龐大，我們擁有行之有效的策略來掌握這些機會。憑藉差異化的產品特性、不斷增長的需求指標以及對商業模式的有針對性的投資，我們的目標不僅是發展壯大，而且要成為這些患者的標準治療方案。

I'll now turn the call over to Liz.

現在我將把電話交給莉茲。

Thank you, Tom. I'm pleased to share some updates on our pipeline, where we continue to make encouraging progress across multiple programs that hold meaningful potential for the future. We've achieved an important milestones recently, including the successful initiation of our Phase 2 study for ACP-204 in Lewy Body Dementia Psychosis and the initiation of our Phase 3 study of trofinetide in Japan.

謝謝你，湯姆。我很高興與大家分享我們研發管線的一些最新進展，我們在多個具有未來發展潛力的專案中持續取得令人鼓舞的進展。我們最近取得了一些重要的里程碑，包括成功啟動了 ACP-204 治療路易氏體失智症精神病的 2 期研究，以及在日本啟動了 trofinetide 的 3 期研究。

Looking ahead, our next expected milestone is the initiation of a Phase 2 study for ACP-211 in the fourth quarter of this year. We are developing ACP-211 in major depressive disorder, a common condition, a significant unmet need.

展望未來，我們下一個預期里程碑是在今年第四季啟動 ACP-211 的 2 期研究。我們正在開發 ACP-211 用於治療重度憂鬱症，這是一種常見疾病，存在著巨大的未滿足需求。

Then in Q1 2026, we expect to initiate our first in human study of ACP-271 in healthy volunteers. To our knowledge, this will be the first time a GPR88 agonist enters the clinic. And it moves us along the path of development, targeting the indications of tardive dyskinesia and Huntington's disease.

然後，我們預計將於 2026 年第一季啟動 ACP-271 在健康志願者中的首次人體研究。據我們所知，這將是 GPR88 激動劑首次進入臨床應用。它推動我們沿著發展之路前進，針對遲發性運動障礙和亨丁頓舞蹈症的症狀。

We also have important projected study readouts coming. We anticipate reporting results from four Phase 2 or Phase 3 studies between now and the end of 2027, underscoring both the breadth of our pipeline and the momentum behind our R&D strategy. Our next major readout is expected to be ACP-204 in Alzheimer's disease psychosis in mid-2026. We're particularly excited about this opportunity and what success could mean for the future trajectory of our company.

我們還有一些重要的研究預測結果即將公佈。我們預計從現在到 2027 年底將公佈四項 2 期或 3 期研究的結果，這將凸顯我們產出線的廣度和我們研發策略的強勁勢頭。我們預計下一個重大結果將於 2026 年中期公佈，屆時 ACP-204 將在阿茲海默症精神病方面發揮作用。我們對這個機會感到格外興奮，也對成功可能對公司未來發展軌跡產生的影響感到興奮。

The unmet need here is substantial. The market opportunity is large, and we have built this program based on a substantial body of learning from pimavanserin at both the molecule and the trial level.

這裡尚未滿足的需求非常巨大。市場機會巨大，我們基於從匹莫範色林分子和試驗層面累積的大量經驗，建構了這個計畫。

Now, switching gears to our international expansion efforts. First, I wanted to provide an update on the regulatory process in the EU for trofinetide. We've been informed by EMA that the earliest that a scientific advisory group could be held would be January. Given this, we now anticipate a CHMP opinion in the first quarter and the EC regulatory decision following the standard regulatory timeline. Meanwhile, in Japan, we've successfully initiated our Phase 3 study, representing a key step towards potentially bringing trofinetide to patients in this important market.

現在，讓我們把重點轉向國際擴張工作。首先，我想向大家介紹歐盟對曲非尼肽的監管流程。歐洲藥品管理局 (EMA) 已告知我們，最早也要到 1 月才能召開科學諮詢小組會議。有鑑於此，我們現在預計 CHMP 將在第一季發表意見，歐盟委員會將按照標準的監管時間表做出監管決定。同時，在日本，我們已成功啟動了 3 期研究，這標誌著我們預計將 trofinetide 帶給這個重要市場的患者，邁出了關鍵一步。

Now, before I close, I wanted to take a moment to acknowledge and thank everyone involved in our Prader-Willi syndrome study and the ACP-101 Clinical Development Program. We are so grateful for the dedication and contributions of the patients, families, study site personnel, and physicians who participated. While the outcome wasn't what we hoped for, we hoped that learning from the trial will benefit the Prader-Willi community and we're actively sharing our insights while we work to add the findings to the scientific literature.

最後，我想藉此機會感謝參與 Prader-Willi 症候群研究和 ACP-101 臨床開發計劃的所有人。我們衷心感謝參與研究的病人、家屬、研究中心工作人員和醫生的奉獻和貢獻。雖然結果不如我們所願，但我們希望從試驗中學到的經驗能夠造福普拉德-威利症候群患者群體，我們正在積極分享我們的見解，同時努力將這些發現添加到科學文獻中。

Our pipeline continues to represent a powerful engine for future growth as we look to advance therapies for underserved neurological disorders and rare disease communities. We anticipate continued activity across our pipeline over the coming years, with multiple programs progressing through key stages of development.

我們的研發管線將繼續成為未來成長的強大引擎，我們將致力於推動針對服務不足的神經系統疾病和罕見疾病族群的治療。我們預計未來幾年我們的研發管線將持續活躍，多個專案將進入關鍵的開發階段。

As a reminder, across our eight disclosed programs, we anticipate initiating five additional Phase 2 or Phase 3 studies between now and the end of 2026, demonstrating the depth and diversity of our development portfolio. And of course, we anticipate reporting for Phase 2 or Phase 3 study results in 2026 and 2027.

再次提醒大家，在我們已公開的八個項目中，我們預計從現在到 2026 年底將啟動五個額外的 2 期或 3 期研究，這反映了我們研發組合的深度和多樣性。當然，我們預計將在 2026 年和 2027 年公佈第 2 或第 3 期研究結果。

And now, I'll pass over to Mark for a review of our financial.

現在，我將把麥克風交給馬克，讓他來回顧我們的財務狀況。

Let me walk you through our third-quarter financial results. We delivered an excellent quarter that underscores the robustness of our commercial portfolio, which enables us to generate strong revenue and cash flows while continuing to invest strategically in growth opportunities.

讓我帶您了解我們第三季的財務表現。我們本季業績表現出色，凸顯了我們商業組合的穩健性，這使我們能夠在持續對成長機會進行策略性投資的同時，創造強勁的收入和現金流。

The third quarter was strong across the board with $278.6 million in total revenues, up 11% year over year. DAYBUE achieved net sales of $101.1 million, up 11% year over year, all of which is attributable to volume growth.

第三季各方面表現強勁，總營收達 2.786 億美元，年增 11%。DAYBUE 實現淨銷售額 1.011 億美元，年增 11%，完全歸功於銷售成長。

The gross-to-net adjustment for DAYBUE in the quarter was 22%. NUPLAZID delivered net sales of $177.5 million, up 12% year over year, with 9% of that growth attributable to volume. The gross-to-net adjustment for NUPLAZID was 25%.

本季 DAYBUE 的毛利淨利調整率為 22%。NUPLAZID 的淨銷售額為 1.775 億美元，年成長 12%，其中 9% 的成長歸功於銷量。NUPLAZID 的毛利淨利調整率為 25%。

Turning to operating expenses, R&D expenses were $87.8 million in the third quarter, up from $66.6 million in 2024, with the increase primarily attributable to higher clinical trial expenses from our ACP-204 LBDP and ACP-101 programs and personnel expenses, partially offset by lower clinical spend from programs that have completed. SG&A expenses for the third quarter were $133.4 million, essentially flat with the prior year.

再來看營運費用，第三季研發費用為 8,780 萬美元，高於 2024 年的 6,660 萬美元，成長主要歸因於 ACP-204 LBDP 和 ACP-101 計畫的臨床試驗費用和人員費用增加，部分被已完成計畫的臨床支出減少所抵銷。第三季銷售、一般及行政費用為 1.334 億美元，與上年基本持平。

Turning to the balance sheet, we ended the quarter with $847 million in cash, compared with $762 million at the end of the second quarter.

從資產負債表來看，本季末我們持有現金 8.47 億美元，而第二季末為 7.62 億美元。

Looking ahead to our full-year 2025 guidance, we're making targeted updates that reflect our strong performance and outlook. For NUPLAZID, we're raising the lower end of our guidance range and increasing at the high end to $685 million to $695 million, up from $665 million to $690 million, reflecting the momentum we're seeing in the business.

展望 2025 年全年業績指引，我們將進行有針對性的更新，以反映我們強勁的業績和前景。對於 NUPLAZID，我們將預期範圍的下限提高至 6.85 億美元至 6.95 億美元，上限從 6.65 億美元至 6.9 億美元提高，這反映了我們在該業務中看到的良好勢頭。

For DAYBUE, we're modifying to include contribution from our named patient supply programs and narrowing our prior guidance range and now expect $385 million to $400 million compared with prior guidance of $380 million to $405 million for US only.

對於 DAYBUE，我們正在進行調整，將指定患者供應計劃的貢獻納入其中，並縮小了先前的指導範圍，現在預計收入為 3.85 億美元至 4 億美元，而先前的指導範圍僅為美國地區 3.8 億美元至 4.05 億美元。

Regarding operating expenses, we now expect R&D expenses of $335 million to $345 million compared with prior guidance of $330 million to $350 million. For SG&A expenses, we now expect $540 million to $555 million compared with prior guidance of $535 million to $565 million.

關於營運費用，我們現在預計研發費用為 3.35 億美元至 3.45 億美元，而先前的預期為 3.3 億美元至 3.5 億美元。對於銷售、一般及行政費用，我們現在預計為 5.4 億美元至 5.55 億美元，而先前的預期為 5.35 億美元至 5.65 億美元。

Our financial strength positions us exceptionally well to finish 2025 strong while making the investments necessary to drive sustained growth in 2026 and beyond.

我們雄厚的財務實力使我們能夠以強勁的勢頭結束 2025 年，同時進行必要的投資，以推動 2026 年及以後的持續成長。

I'll now turn the call back to Catherine for closing remarks.

現在我將把電話轉回給凱瑟琳，請她作總結發言。

Thank you, Mark. As we wrap up today's call, I wanted to reiterate our commitment to finishing 2025 hitting over $1 billion in total revenues, positioning ACADIA for continued growth in 2026 and beyond.

謝謝你，馬克。在今天的電話會議即將結束之際，我想重申我們致力於在 2025 年實現超過 10 億美元的總收入，從而使 ACADIA 在 2026 年及以後繼續保持增長。

We continue to be confident in the stability and growth trajectory driven by our new sales team for DAYBUE, reflected by the over 1,000 patients globally who are now on treatment. We're focused on unlocking NUPLAZID's full potential with our strategic field force expansion and proven patient engagement campaigns. And we now have the elements in place to further accelerate that growth.

我們對 DAYBUE 新銷售團隊帶來的穩定性和成長軌跡充滿信心，目前全球已有超過 1000 名患者正在接受治療，這充分體現了這一點。我們致力於透過策略性的銷售團隊擴張和行之有效的患者參與活動，充分發揮 NUPLAZID 的潛力。現在我們已經具備了進一步加速這一成長的條件。

We are dedicated to advancing our robust pipeline as Liz has described and look forward to the four major readouts expected in 2026 and 2027. We also continue to focus on expanding our portfolio through business development, with our strong balance sheet providing flexibility to pursue partnerships and acquisitions.

正如 Liz 所描述的那樣，我們致力於推進我們強大的研發管線，並期待在 2026 年和 2027 年獲得四項主要成果。我們也將繼續專注於透過業務拓展來擴大我們的投資組合，我們強勁的資產負債表為我們尋求合作夥伴關係和收購提供了靈活性。

Ultimately, our mission drives everything we do, to turn scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. We are here to be their difference.

最終，我們的使命驅動著我們所做的一切，將科學的希望轉化為有意義的創新，為世界各地服務不足的神經系統疾病和罕見疾病群體帶來改變。我們來到這裡，就是要帶給他們改變。

I'm excited about what lies ahead for ACADIA and I'm confident that our strategic investments and unwavering focus on our patients will deliver value for all of our stakeholders.

我對 ACADIA 的未來充滿期待，我相信，我們的策略性投資和對患者的堅定關注將為我們所有的利害關係人帶來價值。

And with that, I'll turn the call back to the operator for questions.

好了，接下來我會把電話轉回接線生，回答大家的問題。

(Operator Instructions)

（操作說明）

Ritu Baral, TD Cowen.

Ritu Baral，TD Cowen。

Good afternoon, guys. Thanks for taking the question this afternoon. I wanted to ask about the expanded NUPLAZID client-facing force. Catherine, how is that organized? Is it along the lines of focus on the newly activated prescribers? How should we think about it in terms of community versus long-term care facilities, which is a way that historically ACADIA has broken up the population for NUPLAZID? And which of those two has the most likelihood for continued growth as you see the market right now? Thank you.

下午好，各位。感謝您今天下午回答我的問題。我想問一下 NUPLAZID 擴大的客戶服務團隊的情況。凱瑟琳，那是怎麼安排的？是否著重於新近啟動的處方醫生？我們應該如何從社區與長期照護機構的角度來考慮這個問題？從歷史上看，ACADIA 就是以這種方式劃分 NUPLAZID 人群的。在你看來，就目前的市場狀況而言，這兩者中哪一個更有可能繼續成長？謝謝。

Thanks, Ritu. Appreciate the question. I'm going to ask Tom to explain. He's been leading the charge for us. So Tom?

謝謝你，麗圖。感謝您的提問。我打算請湯姆解釋一下。他一直是我們衝鋒陷陣的先鋒。湯姆，那又怎樣？

Good afternoon, Ritu. Thank you for the question. So as we think about the expansion, as we mentioned, we plan on executing in Q1 of next year. There's a few different factors I would say are playing into our thinking. So as you think about kind of the new writer base, if we look at kind of dynamics during Q3, we actually saw that in terms of our overall prescription volume, 26% actually came from new writers.

下午好，麗圖。謝謝你的提問。所以，當我們考慮擴張計劃時，正如我們之前提到的，我們計劃在明年第一季實施。我認為有幾個不同的因素影響我們的想法。所以，當我們考慮新的處方藥作者群體時，如果我們看一下第三季度的動態，我們實際上發現，就我們的整體處方量而言，26% 來自新的處方藥作者。

So I think this really talks to the way that our campaigns are working, the effectiveness of the field force. And it's been that kind of underlying dynamic that we've actually seen throughout the year, but actually accelerated in Q3 that's really given us the confidence to pull forward this investment in Q1 of next year.

所以我認為這充分說明了我們競選活動的成效，以及一線隊伍的效率。正是這種潛在的動態，我們今年一直看到，尤其是在第三季加速發展，這真正給了我們信心，讓我們能夠在明年第一季提前進行這項投資。

In relation to your question regarding community versus LTC, actually, we're seeing growth across all channels. We're seeing growth both in the community setting and in the LTC setting as well. And there are various channels that we see the new NUPLAZID scripts being pulled through. So in essence, we're investing in both.

關於您提出的社區與長期照護（LTC）的問題，實際上，我們看到所有管道都在成長。我們看到，無論是在社區還是在長期照護機構，都出現了成長。我們看到新的 NUPLAZID 腳本透過各種管道發布。所以本質上，我們兩者都在投資。

If you're looking at it from an absolute kind of percentage terms, we're actually investing slightly more on a percentage basis in the community. But at the same time, we are going to be modestly expanding the LTC team just given the dynamics that we're seeing in that space as well.

如果從絕對百分比的角度來看，我們實際上在社區的投資比例略高一些。但同時，鑑於我們在該領域看到的動態，我們將適度擴大 LTC 團隊的規模。

So long story short, we're investing in both. And at the same time, making sure that wherever we see a new NUPLAZID script, we're able to pull that through as optimally as possible.

簡而言之，我們兩者都在投資。同時，確保無論何時何地出現新的 NUPLAZID 腳本，我們都能以最佳方式將其執行。

Yigal Nochomovitz, Citigroup.

Yigal Nochomovitz，花旗集團。

Hi. Great. Thank you very much for taking the question. I have one on ACP-204. With the top-line data for Phase 2 coming out middle of next year, I'd be curious if you could comment briefly on what you would see as a clinically meaningful score on the SAPS HD score? And also, if you could just discuss, related to that, why that particular scale is a good one to use in this context. Thank you.

你好。偉大的。非常感謝您回答這個問題。我在ACP-204上有一個。鑑於二期臨床試驗的主要數據將於明年年中公佈，我很想知道您能否簡要評論一下您認為SAPS HD評分中具有臨床意義的分數是多少？另外，能否請您就此討論一下，為什麼在這個背景下使用這種特定的量表是適當的？謝謝。

Thanks, Yigal. Liz is leading that for us, so I'm going to ask her to comment on the scales and the confidence around both of them.

謝謝你，伊加爾。莉茲負責這方面的工作，所以我打算請她對這兩位選手的水平和自信程度發表一下看法。

Yeah. Absolutely. Thank you. So I'll go in reverse order, I suppose, and start with SAPS HD and why we landed there for Alzheimer's disease. So SAPS HD is actually an endpoint that we do have some experience with in our prior pimavanserin trials. It was involved in a pivotal study for PDP and it was also part of the relapse criterion in HARMONY.

是的。絕對地。謝謝。所以我想我會倒序進行，先從 SAPS HD 以及我們為什麼最終選擇它來研究阿茲海默症開始。所以，SAPS HD 其實是我們之前在匹莫範色林試驗中已經累積了一些經驗的終點指標。它參與了 PDP 的一項關鍵研究，也是 HARMONY 復發標準的一部分。

And so overall, we feel like we have a good understanding of that endpoint and its responsiveness. It is well set to measure the domains that we think are important in this patient population, and it's one of several endpoints that are in the literature that are supported as being relevant for this patient population. We are measuring other things as well. So that is how we landed on this as the primary endpoint for the Phase 2 portion of this study.

因此總的來說，我們感覺我們對該端點及其響應能力有了很好的了解。它能夠很好地衡量我們認為對該患者群體而言重要的領域，並且它是文獻中支持與該患者群體相關的幾個終點之一。我們還在測量其他方面。因此，我們最終將此作為本研究第二階段的主要終點。

In terms of how we're looking at this, I'll first note the powering piece, and then I'll talk a little bit about what we're looking for in this trial. In terms of how we size the trial, we actually did this on a size, so we're looking for roughly a moderate effect size, 0.4 effect size on SAPS HD.

關於我們如何看待這件事，我首先要指出動力部分，然後我會稍微談談我們在這次試驗中尋找的是什麼。至於我們如何確定試驗規模，我們實際上是按規模進行的，所以我們正在尋找大致中等的效果大小，SAPS HD 上的效果大小為 0.4。

But really what we're looking for in the Phase 2 is to continue to understand how we progress towards our overall target product profile for 204, and that certainly has an efficacy component to it. But it also is about making sure that this is appropriate for use in this patient population. I think there are a number of important unmet needs here.

但實際上，我們在第二階段的目標是繼續了解我們如何朝著 204 的整體目標產品特性邁進，而這當然與療效有關。但同時也要確保這種方法適合該患者族群使用。我認為這裡存在著許多尚未滿足的重要需求。

Sparing cognition, avoiding daytime sleepiness or sedation, avoiding increasing risk of falls or fractures, avoidance of motor adverse effects. So there's a number of things we're going to be looking for that we feel good about based on what we know about 204's profile.

保護認知功能，避免白天嗜睡或鎮靜，避免增加跌倒或骨折的風險，避免運動上的不良反應。所以，根據我們對 204 號球員的了解，我們會尋找一些我們感覺很好的球員。

But we're sort of holistically going to be looking at the profile of the drug in this trial.

但我們將從整體上檢視該藥物在本次試驗中的表現。

Tessa Romero, JP Morgan.

Tessa Romero，摩根大通。

Hey, Catherine and team. Good afternoon. Thank you for taking our question. So for DAYBUE, you cited the highest quarter-over-quarter referral growth since launch this quarter. Double-clicking, how do you think new patient starts will look sequentially here over the next few quarters in light of the growth you are seeing?

嗨，凱瑟琳和團隊。午安.感謝您回答我們的問題。所以對於 DAYBUE，您提到本季是自推出以來季度環比推薦量成長最高的季度。雙擊後，鑑於您目前看到的增長情況，您認為未來幾季新患者的起始數量會如何變化？

And the second one is just a quick housekeeping. When do you think you will finish enrollment in the Phase 2 trial in ADP? Thank you.

第二件事只是簡單的家事。您預計何時能夠完成ADP二期臨床試驗的受試者招募？謝謝。

Thanks, Tessa. I. I'll ask Tom to kick off about the referral dynamics we're seeing and we saw in the quarter and then Liz can go for the second part.

謝謝你，苔絲。我先請湯姆談談我們目前看到的以及本季看到的轉診動態，然後莉茲可以開始第二部分。

Yeah. Good afternoon. So thank you for the question. In terms of DAYBUE and referral dynamics, we're really encouraged by what we saw in Q3. We saw actually our highest rate of referrals since essentially launch. And if you look over the last twelve months, we're really growing at a pretty decent rate now, which is very encouraging.

是的。午安.謝謝你的提問。就 DAYBUE 和轉診動態而言，我們對第三季所看到的情況感到非常鼓舞。實際上，我們看到了自公司成立以來最高的推薦率。如果你回顧過去十二個月，你會發現我們現在的成長速度相當不錯，這非常令人鼓舞。

In terms of pull-through, you know, just given standard dynamics that you would expect, it does take some time for a referral to then become an actual new-to-brand prescription. Given the dynamics we saw during Q3 and the acceleration that we saw, we would anticipate that we'll continue to see growth in actual active patient counts through Q4 into 2026 and beyond.

就推廣效果而言，你知道，根據你所預期的標準動態，從轉診到真正開出新藥處方確實需要一些時間。鑑於我們在第三季度看到的動態和加速成長，我們預計到 2026 年及以後，實際活躍患者人數將繼續增長。

Liz, you want to touch on that?

莉茲，你想談談這個嗎？

Right, sorry. 204. So, again, just reiterating the predicting midyear for top-line results here. We're really keeping a careful eye on enrollment for the right patient populations. I don't have an exact date of final enrollment here. But we anticipate that would be occurring sort of in the Q2-ish timeframe to enable that midyear.

好的，抱歉。204.所以，再次重申一下，這裡預測的是年中業績。我們正在密切關注目標患者群體的招募。我沒有確切的最終入學日期。但我們預計這種情況會在第二季左右發生，以便實現年中目標。

Brian Abrahams, RBC Capital Markets.

Brian Abrahams，加拿大皇家銀行資本市場。

Hey, good afternoon. Thanks for taking my question. Congrats on the quarter. Maybe another question on 204. Can you talk a little bit about maybe the overall study conduct, how you're feeling about that? And are there any -- I guess, any -- have there been any -- or will there be any looks at the blinded safety data that might inform the potential around having the QTc prolongation advantage or anything you could learn about things like risk of falls or some of the other aspects of the profile that you talked about that could give you kind of an early read into that?

嘿，下午好。謝謝您回答我的問題。恭喜你本季取得佳績。或許可以再問一個關於204的問題。您能否談談您對整個研究開展狀況的感受？那麼，是否有任何——我想，是否有任何——或者將來是否會有任何關於盲法安全性數據的研究，以了解 QTc 間期延長優勢的潛在影響，或者了解諸如跌倒風險或您提到的其他一些方面，從而讓您對這些方面有所了解？

So first, overall, pleased with how the study is progressing thus far in terms of behavior of sites, investigators, the patient population that we're getting in there. We are laser-focused on making sure that we are getting the right patients in here, trying to -- not trying to, we are verifying them with biomarkers to make sure that this is a biologically confirmed Alzheimer's diagnosis, which we think is going to be important.

首先，總體而言，我對目前為止的研究進展感到滿意，包括研究中心、研究人員以及我們招募的患者群體。我們正全力確保把合適的病人接進來，並且——不是試圖，而是透過生物標記來驗證他們，以確保這是生物學上確診的阿茲海默症，我們認為這將非常重要。

From a blinded safety perspective, I'd say a couple of things. We do have a DSM-V that looks after this on an ongoing basis. So we would get any indication of anything that is concerning from that perspective. And thus far, they've been supportive of continuing the study on as planned. And we do monitor on an ongoing basis from just sort of medical monitoring perspective.

從盲人安全的角度來看，我想說幾點。我們有DSM-V來持續處理這個問題。這樣一來，我們就能從這個角度獲悉任何令人擔憂的情況。到目前為止，他們一直支持按計劃繼續進行這項研究。我們會從醫療監測的角度進行持續監測。

That said, I don't like to comment on data from ongoing blinded trials because you never really know how that's going to sort out across arms.

話雖如此，我不喜歡對正在進行的雙盲試驗的數據發表評論，因為你永遠無法真正知道各組之間的結果會如何。

Ash Verma, UBS.

阿什維爾馬，瑞銀集團。

Hi. This is Leona on for Ash. Thank you for taking our question. Just wanted to get back to the risk-adjusted peak sales guide that you have provided at your R&D Day. What is your latest thought on the $2.5 billion and $12 billion peak sales you provided on risk-adjusted and nominal basis?

你好。這是莉安娜替補小智上場。感謝您回答我們的問題。我只是想再次提及您在研發日上提供的風險調整高峰銷售指南。對於您先前提供的經風險調整和名目基礎上分別達到的 25 億美元和 120 億美元的峰值銷售額，您最新的看法是什麼？

It's a little bit difficult to hear, but I think what you asked was how our -- how we're commenting on our peak potential that we talked about at R&D Day and our expectations for the commercial portfolio within that same discussion.

雖然聽起來有點困難，但我認為你問的是我們——我們如何評價我們在研發日上談到的巔峰潛力，以及我們在同一討論中對商業組合的期望。

So let me talk about the overall aspirations for ACADIA. R&D Day, we shared that we aspire to achieve a $12 billion top line should all of our pipeline programs hit during the next two to three years. And as you know, unfortunately, our 101 program did not hit.

那麼，讓我來談談ACADIA的整體願景。在研發日上，我們分享了我們的目標是，如果所有在研項目在未來兩到三年內都能取得成功，那麼我們的營收將達到 120 億美元。如您所知，很遺憾，我們的 101 課程並沒有成功。

And so we would take about $800 million to $1 billion from that top-line expectation. So we would now -- if we were speaking about the same thing, aspire to achieve the $11 billion total peak sales of our currently shared portfolio within that same group of compounds.

因此，我們將從預期總收入中減少約 8 億至 10 億美元。所以，如果我們談論的是同一件事，那麼我們現在的目標是，在同一組化合物中，實現我們目前共享產品組合的 110 億美元高峰銷售總額。

In terms of our commercial aspirations, we shared the $1.5 billion to $2 billion for our commercial brands, NUPLAZID and DAYBUE, and we are still absolutely committed to deliver on that and look forward next year to share a little bit more clarity about both of those brands and our expectations for each of them so that you can understand where we see both of those in the next two to three years.

就我們的商業目標而言，我們為我們的商用品牌 NUPLAZID 和 DAYBUE 分配了 15 億至 20 億美元的預算，我們仍然堅定地致力於實現這一目標，並期待明年能更清晰地分享這兩個品牌以及我們對它們的期望，以便您了解我們對這兩個品牌在未來兩到三年內的發展方向的看法。

Sam Beck, Deutsche Bank.

薩姆·貝克，德意志銀行。

Hey, team. It's Sam on for David Wong. Thanks for taking the question. Just a quick one from us. On NUPLAZID, if you could just provide a little bit more detail on any drivers you're seeing behind the higher average net selling price in the quarter, that'd be great. Thanks.

嘿，團隊成員們。山姆代替大衛王上場。感謝您回答這個問題。我們簡單介紹一下。NUPLAZID，如果您能提供更多關於本季度平均淨售價上漲背後的驅動因素的詳細信息，那就太好了。謝謝。

Yes, I'll ask Mark to take the net selling price question around NUPLAZID.

是的，我會請 Mark 回答有關 NUPLAZID 的淨售價問題。

Yeah. I think at this point, I think when you take all the puts and takes that go into pricing and the fact that the majority or the super majority of sales for NUPLAZID are for Medicare-based patients, kind of our year-over-year pricing is about the rate of inflation.

是的。我認為，就目前而言，考慮到所有影響定價的因素，以及NUPLAZID的大部分或絕大多數銷售額來自Medicare患者這一事實，我們的年度定價大致與通貨膨脹率相當。

That's been our expectation the whole year, except for the kind of one-time pricing benefit in the first quarter. And that's really what we saw in this quarter.

除了第一季的一次性價格優惠之外，這始終是我們全年的預期。而這正是我們本季所看到的。

Evan Seigerman, BMO Capital Markets.

Evan Seigerman，BMO資本市場。

Hi. Malcolm Hoffman on for Evan. Thanks for taking our question. For DAYBUE, with the CHMP opinion expected in the first quarter next year, how can you make sure scripts kind of get off the ground quickly after what could be a positive opinion there?

你好。馬爾科姆·霍夫曼替補埃文上場。感謝您回答我們的問題。對於 DAYBUE 而言，預計明年第一季將公佈 CHMP 意見，如何確保在可能獲得正面意見後，相關劇本能夠迅速啟動？

I'll let Tom take that. He's leading our European team. We're all getting ready for that right now. So Tom, why don't you share that?

我讓湯姆來拿吧。他領導著我們的歐洲團隊。我們現在都在為此做準備。湯姆，為什麼不分享一下呢？

Absolutely. So thank you for the question, Malcolm. As you'd imagine, there's a significant amount of energy being put behind our launch readiness planning in Europe. We're going to be following kind of the standard track that you see for any approval in Europe, so we will be out the gate first in Germany. And I can tell you, we're already gearing up to make sure that the team is ready to go there. So we already have a small group of key account managers. We have a handful of folks working on the medical side of the organization. And they've been very actively engaged already with prescribers -- well, actually with Rett treaters from across the universe. I mean, as you would imagine, each of the European markets looks very different to the US, but we are making sure that we have the right infrastructure in place, the right focus in place.

絕對地。謝謝你的提問，馬爾科姆。正如你所想，我們在歐洲投入了大量精力進行產品上市準備計畫。我們將遵循歐洲審批的常規流程，因此我們將率先在德國獲得批准。我可以告訴你，我們已經在積極準備，確保團隊做好前往那裡的準備。所以我們已經有一個小團隊的大客戶經理了。我們組織裡有幾個人在醫療方面工作。他們已經非常積極地與處方醫生——實際上是與來自世界各地的雷特綜合徵治療醫生——進行互動。我的意思是，正如你所想，每個歐洲市場都與美國市場大相徑庭，但我們正在確保我們擁有合適的基礎設施和正確的焦點。

And I'm pleased to announce that actually in this quarter, we opened our compassionate use program in Germany and have already had a number of requests from German HCPs to enroll their Rett patients in that program, which we think is a very nice kind of early indicator of enthusiasm to use the product. And obviously, we'll be making sure that, that experience is positive as we build out towards the launch.

我很高興地宣布，實際上在本季度，我們在德國啟動了同情用藥計劃，並且已經收到許多德國醫療保健專業人員的請求，希望將他們的雷特氏病患者納入該計劃，我們認為這是一個非常好的早期跡象，表明人們對使用該產品充滿熱情。顯然，我們會確保在產品發布前的準備工作中，使用者能獲得正面的體驗。

You want to share a little bit more about the other countries who have also opened their program in the last quarter?

您想再多介紹一下其他在上個季度也啟動了該專案的國家嗎？

Sure. So also pleased to announce that we have just opened programs in Italy and France. Again, we're pursuing wherever the regulatory and legal frameworks allow us to do so in early engagement programs.

當然。同時，我們也很高興地宣布，我們剛剛在義大利和法國開設了專案。再次強調，在早期參與計畫中，只要監管和法律架構允許，我們都會積極進行。

And as we mentioned on the call, we also have our ongoing rest of world patient access programs as well, which, again, encouragingly, we continue to see ad hoc requests in an unsolicited fashion coming through to the (inaudible).

正如我們在電話會議中提到的，我們還有持續進行的世界其他地區患者准入項目，令人鼓舞的是，我們繼續收到一些主動提出的臨時申請。（聽不清楚）

Sean Laaman, Morgan Stanley.

肖恩拉曼，摩根士丹利。

Good afternoon, Catherine and team. Hope everyone's well. I have a question on the 30% increased investment to NUPLAZID. I guess, could you describe in percentage terms of how many new prescribers you might be reaching with that investment? And what's the headroom there before you get near saturation? And if you can provide any guide on quantifying what the cost of that investment is, that would be really useful.

下午好，凱瑟琳和各位同事。希望大家都好。我有一個關於向 NUPLAZID 增加 30% 投資的問題。我想，您能否用百分比的形式描述一下，透過這項投資，您可能會新增多少處方醫生？在接近飽和之前，還有多少提升空間？如果您能提供任何關於量化這項投資成本的指南，那就太好了。

Yes. I'm going to let Tom talk about the increase and we'll go from there.

是的。我打算讓湯姆談談成長的問題，我們再從那裡開始討論。

So as I mentioned a few minutes ago, we actually saw a very nice uptick during the quarter in terms of new prescriptions increasing through actual new writers, which was over 25% in the quarter. As we look ahead to kind of opportunities for growth and as we've really kind of done a deep dive on what that assessment looks like and where we see the opportunity, we see a ton of opportunity across a wider group of customers that we've been actually calling on to date.

正如我幾分鐘前提到的，本季我們看到新處方數量（透過新處方醫生開出的處方）出現了非常不錯的成長，本季成長超過 25%。展望未來，當我們認真審視成長機遇，並深入研究評估結果以及機會所在時，我們發現，在我們迄今為止接觸的更廣泛的客戶群體中，存在著大量的機會。

Just for reference, historically speaking, we've generally called on neurologists. We've called on some movement disorder specialists and some psychiatrists. But as we look at that 26% who are new to writing prescriptions for NUPLAZID, a ton of those are now coming from primary care. There are often nurse practitioners or advanced practitioners that are now writing NUPLAZID. And in reality, we want to ensure that wherever that prescription is written, whether it be for a patient in the community or in the LTC setting that we're really highlighting the benefit that NUPLAZID can offer.

僅供參考，從歷史上看，我們通常會請神經科醫生幫忙。我們請了一些運動障礙專家和一些精神科醫生來幫忙。但當我們觀察那 26% 首次開立 NUPLAZID 處方的醫生時，會發現其中許多都來自初級保健。現在經常有執業護理師或高級執業人員開立 NUPLAZID 處方。實際上，我們希望確保無論處方開立於何處，無論是社區患者還是長期照護機構的患者，我們都能真正突顯 NUPLAZID 的益處。

And just as a reminder, in terms of [pimavanserin], our share in terms of NBRx remains in the mid-20% range. So if you just think about the upside opportunity that we have, given the size of the overall PDP population in the US, there is still significant headroom for growth, and that's what we're aiming to tap into in 2026.

再次提醒大家，就 [匹莫凡色林] 而言，我們在 NBRx 中所佔的份額仍然在 20% 左右。所以，考慮到美國 PDP 人口的整體規模，如果我們仔細想想我們所擁有的巨大發展機遇，就會發現仍然有很大的成長空間，而這正是我們計劃在 2026 年挖掘的。

And I'll let Mark share a little bit more about how we plan to make that investment.

接下來，我將讓馬克再詳細介紹我們計劃如何進行這項投資。

Yes. I think in terms of people, it's about 50 customer-facing reps I think you can certainly use standard benchmarks for what that cost is. We don't dive into the exact cost at this level of detail, but consider 50 reps plus some home office support and other things that go around that for the kind of overall investment. And we'll just share this kind of within our guidance for SG&A expenses next year.

是的。我認為就人員而言，大約有 50 名面向客戶的代表，我認為你當然可以使用標準基準來衡量這部分成本。我們不會深入探討具體的成本細節，但可以考慮 50 名銷售代表加上一些家庭辦公室支援以及其他相關費用，作為整體投資。明年，我們將把這類資訊納入銷售、管理及行政費用的指導方針中。

Tazeen Ahmad, Bank of America.

塔津·艾哈邁德，美國銀行。

Hi. Good evening. Thanks for taking my question. Maybe just wanted to ask about why you think now is the right time to add to the field force for NUPLAZID? And how are you deciding like what is the right size? Is this a final change or final increase that you think you need to make? Or are there certain targets that you might be monitoring? And if so, can you kind of share a little bit about how you are thinking about needing more or less people as this launch matures?

你好。晚安.謝謝您回答我的問題。我只是想問一下，您為什麼認為現在是為 NUPLAZID 增加現場工作人員的合適時機？那你要如何決定合適的尺寸呢？這是你認為需要做出的最終改變或最終增加的幅度嗎？或者，您是否在關注某些特定目標？如果是這樣的話，您能否稍微談談隨著產品發布日趨成熟，您認為需要增加還是減少人手方面的情況？

Yes, Tazeen, let me start, and then I'll let Tom dive into a little bit more of the details. I think as I came on board last year in September, the team had just started their DTC communications, both the unbranded and the branded. And we weren't sure how impactful that was going to be. We knew it probably would have some traction. But again, we haven't really been in the DTC space for a while since pre-COVID, and we wanted to understand the impact of that type of DTC investment.

是的，塔津，讓我先開始，然後我再讓湯姆深入講解一些細節。我覺得我去年九月加入團隊的時候，團隊才剛開始他們的 DTC 溝通，包括非品牌和品牌溝通。我們當時並不確定這會產生多大的影響。我們知道它可能會有一定的迴響。但話說回來，自從新冠疫情爆發以來，我們已經有一段時間沒有真正涉足 DTC 領域了，我們想了解這類 DTC 投資的影響。

We've now got a year under our belt, and we can see, and you can see in the numbers, real traction in terms of cares and their families being made aware of what the symptoms of Parkinson's disease can be beyond motor. And then those sort of awareness levels now translating into moving into the physician office and physicians now also with our increasing real-world evidence and data generation around NUPLAZID being confident in prescribing it for the right patient to treat their hallucinations and delusions.

現在我們已經走過了一年，我們可以看到，而且從數據中也可以看出，在讓患者及其家人了解帕金森氏症除了運動症狀之外的其他症狀方面，取得了真正的進展。現在，這種認知水平正在轉化為走進醫生診室，隨著我們不斷累積關於 NUPLAZID 的真實世界證據和數據，醫生們也更有信心為合適的患者開立這種藥物來治療他們的幻覺和妄想。

So all of those metrics have come together. And with the important IP win that we had for NUPLAZID, allowing us to continue to feel confident about our IP runway in the US, we felt it was time to reassess the opportunity for NUPLAZID. Tom has been leading that reassessment. And from that, he has made the decision and we have as a management team that it's right to invest now.

所以所有這些指標都綜合起來了。憑藉 NUPLAZID 的重要智慧財產權勝利，我們繼續對我們在美國的智慧財產權儲備充滿信心，因此我們覺得是時候重新評估 NUPLAZID 的機會​​了。湯姆一直在主導這項重新評估工作。因此，他做出了決定，而我們管理團隊也認為，現在是投資的正確時機。

And so maybe, Tom, you can talk a little bit more about some of those investment decisions.

所以，湯姆，或許你可以再多談談那些投資決策。

Yes. I mean I think Catherine captured it really well. I mean it's really been a story of momentum this year for NUPLAZID. And Q3, in particular, has really seen this kind of step change in how we're seeing referrals across the board. And I think given that momentum, that gave us the opportunity in the lens to really have another look at what our customer model look like, especially as you think about the world where we're seeing a number of new prescribers outside of our core kind of target base really beginning to latch on to the benefit that NUPLAZID can offer and really engaging with this community in terms of where they're engaging with health care professionals, which, as a reminder, it can be quite challenging to get time with the neurologist or with a PDP specialist.

是的。我覺得凱瑟琳把這個角色詮釋得非常到位。我的意思是，今年對於 NUPLAZID 來說真是一個勢頭強勁的故事。尤其是在第三季度，我們看到轉診情況發生了顯著變化。我認為，鑑於這種勢頭，這讓我們有機會重新審視我們的客戶模式，尤其是在我們看到許多核心目標群體之外的新處方醫生開始真正意識到 NUPLAZID 的益處，並真正與這個群體互動，尤其是在他們與醫療保健專業人員互動方面。需要提醒的是，與神經科醫生或 PDP 專家預約時間可能相當困難。

And we think that with this expanded reach, we'll be able to actually help these patients really understand the benefit that they can afford and see with NUPLAZID beyond what we're doing today. So it's about really capitalizing on momentum and then ensuring that we have the right structure in place for both today and tomorrow to your question that we believe will put us in a really very strong position to maximize the opportunity ahead.

我們認為，隨著覆蓋範圍的擴大，我們將能夠真正幫助這些患者了解他們能夠負擔得起並能從 NUPLAZID 中獲得的益處，而這遠超我們目前所做的。所以，關鍵在於真正利用這股勢頭，並確保我們為今天和明天都建立正確的結構。對於您提出的這個問題，我們相信這將使我們處於非常有利的地位，從而最大限度地掌握未來的機會。

And just a final thought. We've been very focused at ACADIA on ensuring that we are building a company that's built on a foundation of analytics and insights and data. And within the new expansion, it's being fueled by analytics, data and insights, and we'll be using both that and AI on top of it to ensure that we really efficiently now find our patients and target them.

最後還有一點想法。ACADIA 一直非常注重確保我們打造的公司以分析、洞察和數據為基礎。在新一輪擴張中，我們將以分析、數據和洞察力為驅動力，並在此基礎上運用人工智慧，以確保我們現在能夠真正有效地找到我們的患者並鎖定他們。

And so I think the combination of the new data being sort of driven by a focus on analytics technology. We have a new [CIDO] in place to help us drive that. And so I feel very confident that it will not only be an efficient focus, but also a very effective one.

所以我認為，新數據的出現在某種程度上是由對分析技術的關注所驅動的。我們設立了一個新的[CIDO]來幫助我們推動這個目標。因此，我非常有信心，這不僅會是一個高效的關注點，而且會是一個非常有效的關注點。

Jack Allen, Baird.

傑克艾倫，貝爾德。

Great. Thank you so much for taking the questions, and congrats to the team on the progress made over the course of the quarter. I wanted to ask on the European opportunity for DAYBUE. I just want to --

偉大的。非常感謝您回答這些問題，也恭喜團隊在本季的進展。我想諮詢 DAYBUE 在歐洲的發展機會。我只想--

Jack, you just cut out the end. I heard reimbursement in Europe. Could you just maybe just repeat the question for us?

傑克，你只是把結尾剪掉了。我聽說歐洲有報銷機制。您能再重複一次問題嗎？

Yes. Sorry about that. I hope you have me better now. Yes, I wanted to ask about reimbursement in Europe. I know there were in Canada over the summer.

是的。抱歉。希望你現在感覺好些了。是的，我想諮詢歐洲的報銷事宜。我知道今年夏天加拿大有這樣的情況。

And what your thoughts are and your early conversations are around payers in Europe ahead of a potential European launch for DAYBUE?

在DAYBUE可能在歐洲上市之前，您對歐洲的支付方有哪些想法？您與歐洲支付方的初步溝通狀況如何？

Thanks, Jack. So yes, we are obviously in the middle of discussions and thinking right now around reimbursement in Europe. And you're right, we did have a disappointing decision in Canada.

謝謝你，傑克。所以，是的，我們目前顯然正在討論和思考歐洲的報銷問題。你說得對，我們在加拿大確實做出了一個令人失望的決定。

Tom, do you want to share a little bit more about how we're thinking about reimbursement in terms of the sequential approach to that in Europe?

湯姆，你能否再詳細談談我們在歐洲採取的循序漸進的報銷方式？

Absolutely. So as I mentioned a few minutes ago, our plan would be that we launch first in Germany. And as a reminder, in Germany, as we launch, we have six months of repricing, which we will obviously think very carefully about what that looks like, especially just given some of the other dynamics that we continue to monitor across the board, such as MFN.

絕對地。正如我幾分鐘前提到的，我們的計劃是首先在德國推出。再次提醒大家，在德國，我們推出產品後有六個月的重新定價期，我們顯然會非常仔細地考慮重新定價的具體方案，特別是考慮到我們持續關注的其他一些動態因素，例如最惠國待遇。

But I think given the engagement that we've already started with payers and clinicians, we remain pretty confident actually that our European clinicians and the broader environment are seeing the benefit that DAYBUE can offer.

但我認為，鑑於我們已經與支付方和臨床醫生展開了合作，我們仍然相當有信心，我們的歐洲臨床醫生和更廣泛的領域正在看到 DAYBUE 所能帶來的好處。

And I think as we continue to generate new real-world evidence in the US, we're going to ensure that we leverage that as we go into discussions with European payers and beyond as well to really ensure that the value of DAYBUE is fully understood and realized across the markets where we're launching. So more to come. But again, I think we're excited about the opportunity in Europe and look forward to putting DAYBUE into the hands of many more patients who clearly deserve this treatment.

我認為，隨著我們在美國不斷獲得新的真實世界證據，我們將確保在與歐洲支付方及其他地區的討論中充分利用這些證據，以真正確保 DAYBUE 的價值在我們即將推出的市場得到充分理解和實現。敬請期待更多內容。但話說回來，我們對歐洲的機會感到興奮，並期待將 DAYBUE 帶給更多顯然值得接受這種治療的患者。

Paul Matteis, Stifel.

Paul Matteis，Stifel。

This is Julian on for Paul. I guess just on ACP-204, I was wondering if you guys could clarify the exposure response relationship you've sort of seen from pimavanserin and the work you've done on ACP-204. You often allude to like your learnings that you've had from development as well from an execution perspective as well as from a scientific and biological perspective and why you believe greater potency with ACP-204 will translate to greater clinical benefit?

這裡是朱利安替保羅發言。我想問的是，關於 ACP-204，你們能否解釋一下你們從匹莫凡色林中觀察到的暴露反應關係，以及你們在 ACP-204 上所做的工作。您經常提到您在研發、執行以及科學和生物學方面所獲得的經驗，以及為什麼相信 ACP-204 的更高效力將轉化為更大的臨床益處？

All right. I'll try and get all the things that were in there. So starting with the exposure response. So both in the Alzheimer's disease population as well as in Lewy body, we do have some information from pimavanserin suggesting that with higher levels of exposure, you are able to get to higher levels of improvement on the clinical endpoints and that the median exposure that we're able to achieve with pimavanserin leaves some of that efficacy on the table. So it's sort of midway through that exposure response downward curve.

好的。我會盡量把裡面的東西都找回來。首先從暴露反應說起。因此，無論是在阿茲海默症患者還是路易體失智症患者中，我們都從匹莫範色林中獲得了一些信息，表明隨著暴露水平的提高，臨床終點能夠獲得更高的改善水平，而我們目前能夠達到的匹莫範色林平均暴露水平，使得部分療效未能得到充分發揮。所以它現在正處於曝光響應下降曲線的中段。

And the reason for that, of course, is that unfortunately, with pimavanserin, there was a tendency towards QT prolongation, which limited the ability that we could dose range. So we were not able to push the average patient up to the near maximal efficacy that you could get with higher exposure levels.

當然，原因在於，不幸的是，匹莫範色林有引起 QT 間期延長的趨勢，這限制了我們能夠使用的劑量範圍。因此，我們無法使一般患者的療效達到透過更高暴露量所能達到的接近最大療效的程度。

With 204, we don't have that problem. So thus far, our nonclinical and our clinical data are supportive of the fact that there is not a signal of QT prolongation here. And overall, our experience has been such that it is supportive of moving to our current clinical doses, which we're looking at in our Alzheimer's and Lewy body programs, where the lower dose is roughly equivalent to the exposure with the marketed dose of NUPLAZID and the higher dose is roughly twice that. So those are the pieces that give us some optimism that we have the possibility of exploring higher levels of efficacy. But even if we are not able to actually achieve higher levels of efficacy with the higher doses, we do think that there are some program learnings that we're able to apply here.

204號機就沒有這個問題。因此，到目前為止，我們的非臨床數據和臨床數據都支持以下事實：這裡沒有 QT 間期延長的跡象。總的來說，我們的經驗表明，我們支持採用目前的臨床劑量，我們在阿茲海默症和路易氏體病計畫中正在研究這些劑量，其中較低劑量與上市劑量的 NUPLAZID 的暴露量大致相當，而較高劑量大約是其兩倍。所以，這些因素讓我們樂觀地認為，我們有可能探索更高程度的療效。即使我們無法透過更高的劑量真正達到更高的療效水平，我們也認為有一些專案經驗可以應用到這裡。

Certainly, in both cases, we have programs that are focused specifically on the disease under study. The pimavanserin data in Lewy body is promising, but it's a limited number of patients. And the Alzheimer's program had a single dedicated study and then a subgroup in an overall study. So here, we're going to be able to bring to bear much more robust data evaluating both of these disease states. So those are the things that we take together to give us some real enthusiasm about 204, which, again, we see as potentially having the possibility of really changing the trajectory of this company.

當然，在這兩種情況下，我們都有專門針對所研究疾病的計畫。匹莫範色林治療路易氏體病的數據令人鼓舞，但患者數量有限。阿茲海默症計畫有一項專門的研究，然後又在一項總體研究中設立了一個子群體。因此，我們將能夠利用更可靠的數據來評估這兩種疾病狀態。所以，正是這些因素讓我們對 204 充滿熱情，我們再次認為它有可能真正改變這家公司的發展軌跡。

Marc Goodman, Leerink Partners

馬克古德曼，Leerink Partners

This is Basma on for Mark. We have a question on DAYBUE. You mentioned that the penetration is lower in the patients older than 11 years old. Do you believe that this lower penetration is driven by the higher discontinuation in this age -- in this older age group? The reason why we're asking this question is we would expect that the improvement in communication skills and other effects may be minimal in the older patients and maybe that's a lack of effect will drive greater discontinuations.

這裡是巴斯瑪替馬克報道。我們有一個關於 DAYBUE 的問題。您提到，11歲以上患者的滲透率較低。你認為這種較低的滲透率是由這個年齡層（即老年人群）較高的停用率造成的嗎？我們提出這個問題的原因是，我們預期老年患者的溝通技巧和其他方面的改善可能微乎其微，而這種效果的缺乏可能會導致更多的人停止治療。

And also, could you clarify whether the age of Rett patients in general seeking treatment is skewed to the younger age group or it's basically uniform across the different age?

另外，您能否澄清一下，尋求治療的雷特症候群患者的年齡總體上是偏向年輕人群，還是各個年齡層的年齡分佈基本一致？

Thank you. I think there's some important opportunities there to clarify what the data actually says about DAYBUE efficacy across the age groups and to share a little bit more about what we're seeing in the field.

謝謝。我認為這裡有一些重要的機會，可以澄清數據實際上表明 DAYBUE 在各個年齡層中的療效，並分享更多我們在現場看到的情況。

So Tom, do you want to answer it? And if Liz, you've got any efficacy points to add on top, that would be good.

湯姆，你想回答這個問題嗎？莉茲，如果你還有什麼功效上的補充，那就太好了。

Absolutely. So thank you for the question. So I mean, going back to the original premise, do we think that the reason that we are slightly lower penetrated in patients greater than 11 years and older is discontinuations? I don't think that that's the case. I mean, essentially, what we have to remember is the vast majority of patients who have been kind of treated so far, again, if we look at penetration by age are those in the two to four age bracket.

絕對地。謝謝你的提問。所以，回到最初的前提，我們認為我們在 11 歲及以上患者中的滲透率略低的原因是停藥嗎？我不認為情況是這樣。我的意思是，從本質上講，我們必須記住的是，到目前為止接受治療的絕大多數患者，如果我們按年齡來看，都是兩到四歲的年齡層。

Newly diagnosed patients, they're easy to identify, and they generally fall under the focus of the center of excellence. And I think that that's a group that we've been able to penetrate very early on.

新確診的患者很容易識別，他們通常屬於卓越中心的重點關注對象。我認為我們已經很早就打入了這個群體。

If you look at the last quarter, interestingly, 65% of our patients were actually older than the age of 11. So it's a group of patients that we believe that we can really begin to penetrate further still. And especially with our LOTUS real-world evidence generation, which, as a reminder, has patients as old as 60 included in it, we do continue to see a group of -- well, we continue to see patients seeing benefit irrespective of age.

有趣的是，如果你看一下上個季度，你會發現我們65%的患者其實年紀都超過了11歲。所以我們相信，我們可以真正開始進一步深入了解這部分患者群。尤其是我們 LOTUS 真實世界證據的生成，需要提醒的是，該證據中包含了年齡高達 60 歲的患者，我們確實繼續看到一組——嗯，我們繼續看到患者無論年齡大小都能從中受益。

And this has been part of the strategy as we've extended our reach beyond centers of excellence because many of these patients who are slightly older, unfortunately, they sit within the community setting, they may not be under the care of a COE, and they may not even be aware of DAYBUE. In fact, we just heard about a patient story yesterday for a patient in Kansas, who was receiving -- sorry, DAYBUE for the first time, but before they came into the center have never even been made aware of DAYBUE.

隨著我們將服務範圍擴展到卓越中心之外，這已成為我們策略的一部分，因為許多年齡稍大的患者，不幸的是，他們生活在社區環境中，可能沒有得到卓越中心的照顧，甚至可能不知道 DAYBUE 的存在。事實上，我們昨天才剛聽到一個堪薩斯州患者的故事，他第一次接受 DAYBUE 治療，但在來到中心之前，他甚至從未聽說過 DAYBUE。

So I think it really does talk to the fact that we have more work to be done, both in terms of educating the community about what Rett is and what to look for and at the same time, ensuring that they understand the benefit that DAYBUE can offer to these patients irrespective of their age.

所以我認為這確實說明我們還有很多工作要做，既要教育社區了解雷特綜合徵是什麼以及需要注意什麼，同時也要確保他們了解 DAYBUE 可以為這些患者帶來的益處，無論他們的年齡如何。

Liz, do you want to enhance a little bit on that? Or is there anything you want to add about the data that we've shared?

莉茲，你想再補充一點嗎？或者，關於我們分享的數據，您還有什麼要補充的嗎？

Sure. I agree with everything that Tom said there. I think that going back even to the original clinical trial, there is supportive data suggesting that there's efficacy in patients above 11 as well as below 11, though it is a somewhat smaller proportion of our overall patient population.

當然。我完全同意湯姆說的所有話。我認為，即使追溯到最初的臨床試驗，也有支持性數據表明，對於 11 歲以上的患者以及 11 歲以下的患者，該療法都有效，儘管這部分患者在我們整體患者群體中所佔比例較小。

But exactly, as Tom said, we've also been tracking these patients in LOTUS as well and see evidence of improvement in those patients as well. So I think that it is an increasing body of evidence that supports the fact that DAYBUE does bring benefit to patients in line with the indication, which is not restricted in terms of the age.

但正如湯姆所說，我們也一直在追蹤 LOTUS 中的這些患者，也看到了這些患者病情有所改善的跡象。所以我認為，越來越多的證據表明，DAYBUE 確實能為符合適應症的患者帶來益處，而適應症並沒有限制年齡。

Yes, I think that's the key. We see DAYBUE efficacy across age ranges. And we want to ensure that neurologists and treating physicians are educated about the data and don't have preconceived notions about specific efficacy in specific age groups. And that's a big focus of Tom and Allyson and the team as we move into next year to really ensure that, that data is shared specifically to encourage the physicians that aren't so well versed in rat to really look at the data and think about it for all patients, not just younger patients. So with that, it's a good question.

是的，我認為這是關鍵。我們發現 DAYBUE 在各個年齡層都有效。我們希望確保神經科醫生和治療醫生了解相關數據，並且不會對特定年齡層的特定療效抱持先入為主的觀念。而這正是 Tom、Allyson 和團隊在明年工作的重點，我們要確保這些數據得到共享，特別是鼓勵那些不太熟悉老鼠的醫生認真查看數據，並思考如何將其應用於所有患者，而不僅僅是年輕患者。所以，這確實是個好問題。

Ami Fadia, Needham and Company.

Ami Fadia，Needham and Company。

Hi. This is Puna on for Ami. Congratulations on the quarter. My first question is we've seen some IRA impact feedback coming for therapies such as [AUSTEDO]. Is there any read-through for NUPLAZID based on this? Is this more positive than you expected?

你好。這是 Puna 為 Ami 主持節目。恭喜你本季取得佳績。我的第一個問題是，我們已經看到一些關於IRA影響的回饋意見，例如針對某些療法的回饋意見。[AUSTEDO]基於此，是否有針對 NUPLAZID 的任何解讀？這比你預期的好嗎？

And my second question is, how is ACP-211 differentiated from SPRAVATO and the emerging psychedelic class in depression?

我的第二個問題是，ACP-211 與 SPRAVATO 和新興的迷幻藥在憂鬱症治療上有何不同？

I'm going to ask Mark to answer the IRA question first, and then I'll ask Liz to talk about the differentiation of ACP-211.

我先請 Mark 回答 IRA 問題，然後再請 Liz 談談 ACP-211 的差異。

I think on the IRA there's not a great comp yet for NUPLAZID as NUPLAZID is the first and only approved therapy for its indication. And so it doesn't have competition with other branded agents as well as we haven't seen a comp like that go through the IRA negotiation.

我認為在IRA市場上，NUPLAZID還沒有很好的競爭對手，因為NUPLAZID是第一個也是唯一一個被批准用於其適應症的療法。因此，它與其他品牌代理商之間沒有競爭，而且我們也沒有看到類似的競爭對手經歷 IRA 談判。

So simply speaking, I think we'll see how this evolves as and if NUPLAZID goes through negotiations or others in a more comparable situation and that may or may not have read-through for what a NUPLAZID negotiation may look like.

簡而言之，我認為我們將拭目以待，看看 NUPLAZID 是否會進行談判，或者其他情況是否類似，以及這種情況是否能為 NUPLAZID 的談判提供參考。

As far as switching gears quite a lot to 211 as far as 211 is concerned. So we've designed 211 as an oral therapy. And what we're hoping for here is the potential for ketamine-like efficacy or SPRAVATO-like efficacy with a very different patient experience in terms of the degree of required in-office monitoring. And the data that we have so far supports that, both in terms of animal models that suggest efficacy as well as lacking sedative impacts or dissociation. And in healthy volunteers in our Phase 1 study, we've demonstrated the ability to reach high doses with no sedation and minimal dissociation.

至於 211 號公路，就 211 號公路而言，情況已經發生了很大的變化。因此，我們將 211 設計成一種口服療法。我們希望它能達到類似氯胺酮或 SPRAVATO 的療效，同時在所需的診間監測程度方面為患者帶來截然不同的體驗。目前我們掌握的數據也支持這一點，無論是動物模型都顯示了療效，而且沒有鎮靜作用或分離作用。在我們的 1 期研究中，我們對健康志願者進行了測試，結果表明，在不產生鎮靜作用和極少產生分離症狀的情況下，可以達到高劑量。

We think if this reads through in our upcoming clinical trials, we are looking to start this Phase 2 in 211 before the end of this year. And we designed this, of course, to look at efficacy, but also very importantly, to rule out unacceptable levels of sedation and dissociation. So we think that there is a potential for a really appealing product here.

我們認為，如果即將進行的臨床試驗結果證實了這一點，我們計劃在今年年底前啟動 211 年的 2 期臨床試驗。當然，我們設計這個實驗是為了檢驗療效，但更重要的是，是為了排除不可接受的鎮靜和分離程度。所以我們認為這款產品很有潛力，會非常受歡迎。

Salveen Richter, Goldman Sachs.

薩爾文·里克特，高盛。

Good afternoon. Thanks for taking my question. On the LBD psychosis study, can you just help us understand the rationale for enrichment of the Phase II with the additional patient groups, including [LPP] and the PDP population instead of just focused on Lewy Body Dementia psychosis specifically?

午安.謝謝您回答我的問題。關於 LBD 精神病研究，您能否幫助我們理解，為什麼 II 期研究要納入更多患者群體，包括 [LPP] 和 PDP 人群，而不是僅僅關注路易體癡呆精神病？

So Lewy Body Dementia psychosis is sort of an umbrella term that actually encapsulates dementia with Lewy bodies as well as Parkinson's disease dementia psychosis. And so what we're looking to do in our Lewy body program is actually ensure that we're looking at roughly equivalent numbers of both of those two patient populations to understand any similarities and differences in terms of how they behave. This will help us in terms of designing what future studies could look like.

所以，路易氏體失智症精神病是一個統稱，它實際上包含了路易氏體癡呆症以及帕金森氏症精神病。因此，我們在路易氏體病計畫中想要做的，實際上是確保我們觀察這兩個患者群體的數量大致相等，以了解他們在行為方式上的相似之處和不同之處。這將有助於我們設計未來研究的方向。

When we look at the population in the pimavanserin data set that is specifically that Lewy Body Dementia psychosis, the numbers are relatively small, but it is very promising data, and that's part of what had us move this program forward and part of what makes us enthused about it.

當我們查看匹莫範色林資料集中的人群，特別是路易體癡呆症精神病患者時，雖然人數相對較少，但數據非常有希望，這也是我們推進該計畫的部分原因，也是我們對此充滿熱情的原因之一。

Sumant Kulkarni, Canaccord Genuity.

Sumant Kulkarni，Canaccord Genuity。

Good afternoon. You're investing more on NUPLAZID, and there have been some questions already about that. But we're finally seeing some excitement in the Parkinson's market then AbbVie recently announced the sales force expansion on the strength they're seeing for Vyalev and the potential approval for tavapadon.

午安.您正在加大對 NUPLAZID 的投資，目前已經有人對此提出了一些疑問。但我們終於看到帕金森氏症市場出現了一些令人興奮的跡象，艾伯維最近宣布擴大銷售團隊，因為他們看到了 Vyalev 的強勁表​​現以及 tavapadon 可能獲得批准。

So how do you think this additional focus on the Parkinson's market from a relatively large player might influence the market or diagnosis rates for psychosis associated with Parkinson's?

那麼，您認為一家相對較大的公司對帕金森氏症市場的額外關注可能會對帕金森氏症相關精神病的市場或診斷率產生怎樣的影響？

So I'll start and then maybe give a perspective from Tom. So let's just start by reminding everybody that NUPLAZID is the only branded product approved for Parkinson's disease psychosis. But as we see more activity in an overall Parkinson's market, I think what history would tell us is that once more -- once larger companies are in the market talking about Parkinson's disease more fulsomely with more people, there does tend to be an increase in terms of awareness of different elements of the disease.

那我先開始，然後也許會從湯姆的角度談談我的看法。首先，我們要提醒大家，NUPLAZID 是唯一獲準用於治療帕金森氏症精神病的品牌產品。但隨著帕金森氏症市場整體活動的增加，我認為歷史會告訴我們，一旦大型公司進入市場，更全面地與更多人談論帕金森氏症，人們對這種疾病的不同方面的認識往往會提高。

And as Tom has already alluded to, 50% of patients suffer from psychosis or suffer from the hallucinations and delusions of Parkinson's at some point during their journey. And so it wouldn't be unsurprising to sort of see that rate increase.

正如湯姆已經提到的那樣，50% 的患者在帕金森氏症的某個階段會患上精神病或出現幻覺和妄想。因此，利率上升也就不足為奇了。

What we do know right now is that there's a relatively low level of awareness amongst families and caregivers of those symptoms, which is why we've been putting effort behind the unbranded campaign. And that would still have to be true because those sort of non-motor-related symptoms generally go undiscussed and unfocused on by the physicians and their families. And what we have understood is that we need to continue to talk about them to ensure that those questions are raised.

我們現在所知道的是，家庭成員和照護者對這些症狀的認識程度相對較低，這就是為什麼我們一直在努力進行這項非品牌宣傳活動的原因。而且這種情況仍然會發生，因為這類與運動無關的症狀通常不會被醫生及其家人討論和關注。我們已經了解到，我們需要繼續討論這些問題，以確保這些問題被提出。

As we continue to educate physicians with our expansion Tom, I think we probably hope to see that the physicians are starting to learn more about it themselves.

隨著我們不斷擴大規模，湯姆，我想我們可能希望看到醫生開始更多地了解它。

But I don't think without us, it's going to be sort of a natural place for them to go with other companies. What would you say on that?

但我認為，如果沒有我們，他們很可能會自然地選擇與其他公司合作。你對此有何看法？

No. I mean one thing I would say, I mean, I think it's well recognized that Parkinson's in general is one of the fastest-growing neurological disease types in the United States. As a reminder, there's estimated to be about 1 million patients with Parkinson's in the US.

不。我的意思是，我想說的是，帕金森氏症總體上是美國成長速度最快的神經系統疾病之一，這一點已被廣泛認可。提醒一下，據估計美國約有 100 萬帕金森氏症患者。

And as we kind of then take a step down into those patients who are actually diagnosed with hallucination delusions, it's somewhere between 40% and 50% of that population at any given time. By our estimate, there's about 130,000 of those patients who are actually diagnosed atypical antipsychotic, pardon me, during the course of the disease.

然後，當我們進一步了解那些被診斷出患有幻覺妄想症的患者時，發現任何時候，這類患者都佔該族群的 40% 到 50%。據我們估計，大約有 13 萬名患者在患病過程中被診斷為非典型抗精神病藥物（抱歉，我這麼說不太準確）。

That's not to say there's more work to be done here because I think if you look at most patients as they go through their Parkinson's journey, to begin with, they are fully focused on the movement elements of the disease. And unfortunately, not everybody is educated on hallucination delusions that can commonly concur. And I think one of the key calls to action that we're trying to drive at the moment that if a patient, even if early in their disease course is experiencing hallucinations or delusions that, that is a trigger point to start treatment.

這並不是說這裡還有更多的工作要做，因為我認為，如果你觀察大多數帕金森氏症患者在患病初期，他們首先關注的是這種疾病的運動方面。但不幸的是，並非每個人都了解可能同時出現的幻覺和妄想。我認為我們目前正在努力推動的關鍵行動呼籲之一是，如果患者即使在疾病早期出現幻覺或妄想，那就是開始治療的觸發點。

That's a trigger point to make sure that they're engaging with an HCP, whether it be a neuro or it be their primary care physician to make sure that they're having that dialogue to ensure that appropriate action can be taken. We believe that, that's where, quite honestly, NUPLAZID can play a really critical role just given its profile, given its safety profile and given the growing body of evidence that Catherine mentioned earlier on.

這是一個觸發點，要確保他們與醫療保健專業人員（無論是神經科醫生還是他們的初級保健醫生）進行溝通，以確保他們進行對話，從而採取適當的行動。我們認為，坦白說，鑑於 NUPLAZID 的特性、安全性以及 Catherine 之前提到的越來越多的證據，它能夠在這方面發揮非常關鍵的作用。

So I think taken together, clearly more upside, and I think that that's one of the reasons that we have decided that now is the time to really up-invest in our customer-facing approach to NUPLAZID as we look forward.

所以我認為綜合來看，顯然更有發展潛力，這也是我們決定現在是時候增加對 NUPLAZID 面向客戶方式的投資力度的原因之一。

Now is the time is a great way, I think, to end that question. Thanks very much.

我認為，現在正是結束這個問題的絕佳時機。非常感謝。

Since there are no further questions, I'll pass it along to Mrs. Owen Adams to proceed to closing remarks.

由於沒有其他問題，我將把發言權交給歐文·亞當斯夫人，由她來作總結發言。

Thanks, everybody, for your questions. We're really excited about what lies ahead for ACADIA, and we look forward to our next call.

謝謝大家的提問。我們對 ACADIA 的未來發展感到非常興奮，並期待下次通話。

Thank you for your participation in today's conference call. This concludes the presentation. You may now disconnect.

感謝您參加今天的電話會議。演講到此結束。您現在可以斷開連線了。