Acadia Pharmaceuticals Inc. (ACAD) 2026 Q2 法說會逐字稿

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

各位女士、先生，感謝您稍候。我叫 Abby，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 年第二季財報電話會議。（接線員指示）。

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

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

Good afternoon, and thank you for joining us on today’s call to discuss ACADIA’s second quarter 2026 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 Thomas Garner, our Chief Commercial Officer, who will discuss our commercial brands, DAYBUE and NUPLAZID.

各位下午好，感謝各位參加今天的電話會議，討論 ACADIA 2026 年第二季財務結果。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；接著是我們的商務長 Thomas Garner，他將介紹我們的商業品牌 DAYBUE 與 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.

同時出席的還有：研發主管、執行副總裁 Elizabeth Thompson 博士，她將更新我們的研發管線計畫；以及我們的財務長 Mark Schneyer，他將回顧財務重點。

Catherine 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.

接著 Catherine 將做結語，之後我們將開放提問。我們使用補充簡報投影片，已發布於公司網站「活動與簡報」專區。在今天的電話會議中，我們將同時討論 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。

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 investor page of the company’s website.

非 GAAP 財務衡量指標（亦稱調整後財務衡量指標）僅涉及 2025 年 NUPLAZID 銷售及其對總營收的影響。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；相關資料已發布於公司網站投資人專區。

Before proceeding, I’d 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.

在開始之前，我想提醒各位：今天的電話會議中，我們將依據 1995 年《私人證券訴訟改革法》之定義，提出若干前瞻性陳述。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，詳載於我們向美國證券交易委員會（SEC）提交的文件中。敬請注意勿過度依賴這些前瞻性陳述；其僅截至今日有效。除法律要求外，隨著情勢變化，我們不承擔更新或修訂任何前瞻性陳述之義務。

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

現在我將電話會議交給 Catherine 進行開場致詞。

Thank you, Al. Good afternoon, everyone, and thank you for joining us today. I am pleased to report that ACADIA delivered an outstanding second quarter, demonstrating strong commercial execution across both DAYBUE and NUPLAZID. We also continue to make important progress across our pipeline, led by remlifanserin in Alzheimer’s disease psychosis.

謝謝你，Al。各位下午好，感謝各位今天加入我們。我很高興向各位報告，ACADIA 在第二季交出亮眼成績，展現 DAYBUE 與 NUPLAZID 兩大產品的強勁商業執行力。我們也持續在研發管線上取得重要進展，其中以阿茲海默症精神病（psychosis）適應症的 remlifanserin 為首。

Let me start with our financial performance. We achieved total revenues of $308 million in the second quarter, representing 17% year-over-year growth on an adjusted basis. This performance reflects strong execution and continued demand for DAYBUE and NUPLAZID.

我先從財務表現談起。第二季我們達成總營收 3.08 億美元，按調整後口徑計算，年增 17%。此一表現反映了強勁的執行力，以及市場對 DAYBUE 與 NUPLAZID 的持續需求。

Turning to DAYBUE, the brand delivered net sales of $125 million in the second quarter, representing 30% year-over-year growth. This strong performance was driven by meaningful uptake of DAYBUE STIX, our recently launched powder for oral solution, which is resonating with patients and caregivers in the US.

談到 DAYBUE，該品牌第二季淨銷售額達 1.25 億美元，年增 30%。這項強勁表現主要來自 DAYBUE STIX 的顯著採用成長；DAYBUE STIX 是我們近期上市的口服溶液粉末劑型，正在美國患者與照護者之間引發共鳴。

The strong early adoption of DAYBUE STIX reinforces our confidence in this differentiated delivery option and supports the brand’s continued growth trajectory. Based on these strong results, we are raising our 2026 guidance range for DAYBUE to $480 million to $510 million.

DAYBUE STIX 早期的強勁採用，進一步強化我們對此差異化給藥選項的信心，並支持該品牌持續成長的軌跡。基於這些強勁成果，我們上調 2026 年 DAYBUE 指引區間至 4.8 億至 5.1 億美元。

I am also delighted that we recently received a positive opinion from the CHMP following a reexamination process. This outcome represents a significant win for patients with Rett syndrome across Europe and reaffirms the value of DAYBUE as a foundational therapy.

我也很高興地宣布，我們近期在重新審查程序後，獲得 CHMP 的正面意見。此一結果對歐洲雷特氏症患者而言是一項重大利多，也再次肯定 DAYBUE 作為基礎治療的價值。

We are grateful to the CHMP for its thorough review and pleased to be moving closer to the opportunity to bring this therapy to patients in Europe. This positive opinion, along with strong DAYBUE STIX performance, reinforces our confidence to achieve our ambition of $700 million in DAYBUE sales in 2028.

我們感謝 CHMP 的全面審查，也很高興距離將此療法帶給歐洲患者的機會更近一步。這項正面意見，加上 DAYBUE STIX 的強勁表現，進一步強化我們達成 2028 年 DAYBUE 銷售額 7 億美元目標的信心。

For NUPLAZID, the brand delivered net sales of $183 million in the second quarter, up 10% year-over-year on an adjusted basis. The underlying business remains strong, supported by continued demand growth, disciplined execution, and impact from our expanded field force. We remain confident in our path to deliver approximately $1 billion in NUPLAZID net sales in 2028.

至於 NUPLAZID，該品牌第二季淨銷售額為 1.83 億美元，按調整後口徑計算年增 10%。在需求持續成長、紀律性的執行，以及我們擴增前線團隊所帶來的效益支持下，核心業務依然強勁。我們仍對在 2028 年達成 NUPLAZID 淨銷售額約 10 億美元的路徑充滿信心。

Looking ahead, our most important near-term pipeline milestone is the upcoming Phase 2 readout for remlifanserin in Alzheimer’s disease psychosis. We now expect to report top-line results from this study in September to October of this year.

展望未來，我們近期研發管線最重要的里程碑，是 remlifanserin 用於阿茲海默症精神病的第二期試驗即將公布結果。我們目前預期將於今年 9 月至 10 月公布該研究的主要結果（top-line results）。

If successful, remlifanserin has the potential to be transformational for ACADIA, with peak sales potential of estimated $4 billion across Alzheimer’s disease psychosis and Lewy body dementia psychosis. With that overview, let me now turn the call over to Tom to provide more detail on our commercial performance.

若試驗成功，remlifanserin 有潛力為 ACADIA 帶來變革性影響；其在阿茲海默症精神病與路易體失智症精神病兩項適應症合計的峰值銷售潛力，估計可達 40 億美元。以上為整體概述，接下來我將把電話會議交給 Tom，請他更詳細說明我們的商業表現。

Thank you, Catherine, and good afternoon, everyone. I am excited to report another strong quarter for DAYBUE, which generated $125 million in net sales in the second quarter, representing 30% year-over-year growth, driven almost entirely by volume.

謝謝你，Catherine，各位下午好。我很高興報告 DAYBUE 再度交出強勁的一季：第二季淨銷售額達 1.25 億美元，年增 30%，幾乎完全由銷量成長所帶動。

Performance was led by continued strength in the US business, with additional contributions from our name patient supply programs. DAYBUE continues to strengthen its position as the foundational standard of care for Rett syndrome, and our second quarter results reflect what we believe to be the growing confidence that physicians, patients, and caregivers have in the therapy.

表現主要由美國業務的持續強勁所帶動，並有我們的具名患者供藥計畫（name patient supply programs）帶來額外貢獻。DAYBUE 持續鞏固其作為雷特氏症基礎標準治療的地位；我們第二季的結果反映出我們認為醫師、患者與照護者對此療法的信心正在提升。

Demand trends accelerated during the quarter as we expanded the launch of DAYBUE STIX beyond Centers of Excellence, which is engaging new patients and bringing previously discontinued patients back to therapy.

隨著我們將 DAYBUE STIX 的上市推廣從卓越中心（Centers of Excellence）擴展至更廣範圍，季度內需求趨勢加速成長，這不僅吸引新患者，也讓先前停用的患者重新回到治療。

Importantly, the number of patients returning to DAYBUE reached a record level during the second quarter. Of note, approximately 40% of all US DAYBUE patients were receiving STIX by the end of the quarter. This rapid uptake highlights the significant value STIX is providing to patients and caregivers and reinforces its role as an important growth driver for the DAYBUE franchise.

重要的是，第二季回到 DAYBUE 治療的患者人數創下新高。值得一提的是，截至季度末，美國所有 DAYBUE 患者中約有 40% 正在使用 STIX。如此快速的採用凸顯 STIX 為患者與照護者帶來的顯著價值，也強化其作為 DAYBUE 產品線重要成長動能的角色。

Turning to DAYBUE outside the United States, we achieved a major regulatory milestone late in the quarter with the receipt of positive CHMP opinion for the treatment of Rett syndrome. We have already begun preparations for commercialization in the European Union following expected approval of DAYBUE by the European Commission.

談到美國以外的 DAYBUE，我們在本季末取得一項重大的法規里程碑：獲得 CHMP 對雷特氏症治療的正面意見。在預期歐盟執委會核准 DAYBUE 後，我們已開始為在歐盟的商業化做準備。

We’ve assembled a highly experienced team and remain on track to launch in Germany in early Q4. In parallel, we expect to submit pricing and market access submissions in our planned launch markets this year, positioning us for broader expansion across Europe as we work to secure reimbursement approvals.

我們已組建一支經驗豐富的團隊，並仍按計畫於第四季初在德國上市。同時，我們預期今年將在規劃的上市市場提交定價與市場准入申請，使我們在爭取給付核准的同時，為在歐洲更廣泛的擴張做好布局。

In addition, our name patient supply programs are expected to remain a meaningful contributor to growth through 2026, driven by increasing awareness of DAYBUE globally. Taken together, these trends reinforce our confidence in DAYBUE’s increased guidance. And with that, let me turn to NUPLAZID.

此外，我們的具名病患供藥計畫預期將持續至 2026 年，並仍將是成長的重要貢獻來源，動能來自全球對 DAYBUE 認知度的提升。綜合而言，這些趨勢強化了我們對 DAYBUE 上調財測指引的信心。接下來，讓我轉到 NUPLAZID。

NUPLAZID delivered another strong quarter, generating $183 million in net sales, representing 10% year-over-year growth on an adjusted basis, driven primarily by volume. We were particularly encouraged by the continued momentum in new patient prescriptions, which have increased 20% year-over-year, representing the highest quarterly volume since the first quarter of 2018.

NUPLAZID 再度交出強勁的一季，淨銷售額達 1.83 億美元；以調整後基礎計算，年增 10%，主要由銷量帶動。我們尤其受到新病患處方持續增長動能的鼓舞，新病患處方量年增 20%，為自 2018 年第一季以來的最高單季量。

Turning to our expanded field force, execution remains on track, and we are beginning to see the early benefits of that investment emerge, consistent with the six to nine month ramp period we anticipated. Since expanding the team, we have seen a significant increase in call activity and improved the depth and frequency of engagement with our highest priority customer segments.

談到我們擴編的外勤團隊，執行進度仍按計畫推進，我們也開始看到這項投資的早期效益浮現，符合我們先前預期的 6 至 9 個月爬坡期。自團隊擴編以來，我們看到拜訪活動顯著增加，並提升了與最高優先客戶族群互動的深度與頻率。

As a result, we have now reached over 12,000 priority healthcare providers since February, significantly expanding our presence across the clinicians who care for patients living with Parkinson’s disease psychosis.

因此，自二月以來，我們已觸及超過 12,000 位優先醫療照護提供者，顯著擴大我們在照護帕金森氏病精神病（psychosis）患者之臨床醫師族群中的能見度。

Our direct consumer investments continue to be a meaningful driver of awareness, patient identification, and activation. During Parkinson’s Awareness Month in April, our NUPLAZID-branded campaign, Mind Your Mind, and the refreshed More to Parkinson’s initiative delivered record audience reach and generated strong engagement across digital and social channels.

我們對直接面向消費者的投資，持續成為提升認知、辨識病患並促進啟動治療的重要驅動力。在四月的帕金森氏病認知月期間，我們以 NUPLAZID 品牌推出的 Mind Your Mind 活動，以及更新版的 More to Parkinson’s 計畫，創下受眾觸及新高，並在數位與社群渠道帶來強勁互動。

More importantly, these efforts are translating into action, as reflected in substantial sequential increases in both branded and unbranded patient conversion, reinforcing our ability to connect patients and caregivers with information about Parkinson’s disease psychosis and the treatment options available to them.

更重要的是，這些努力正在轉化為實際行動，反映在品牌與非品牌病患轉換率的顯著環比提升，進一步印證我們能將病患與照護者連結到關於帕金森氏病精神病及其可用治療選項的資訊。

As we pair these awareness-building efforts with our expanded field force, we are increasing both physician and patient recognition of NUPLAZID and further strengthening the foundation for sustainable growth. The leading indicators we’re seeing across the market, including growing disease awareness, increased patient engagement, and rising new prescriptions, gives us confidence in the near and long-term trajectory for NUPLAZID.

當我們將這些提升認知的努力與擴編的外勤團隊相結合時，我們正在提高醫師與病患對 NUPLAZID 的辨識度，並進一步強化可持續成長的基礎。我們在市場上看到的領先指標，包括疾病認知提升、病患互動增加以及新處方上升，使我們對 NUPLAZID 的短期與長期發展軌跡充滿信心。

And with that, I’ll turn the call over to Liz.

接下來，我把電話交給 Liz。

Thank you, Tom, and good afternoon, everyone. Today, I’ll provide a few brief updates across our clinical-stage programs. Let me start with remlifanserin, which, as Catherine said, represents a potentially transformational opportunity for ACADIA Pharmaceuticals.

謝謝你，Tom，各位下午好。今天我將就我們的臨床階段計畫提供幾項簡要更新。我先從 remlifanserin 開始；如 Catherine 所說，這對 ACADIA Pharmaceuticals 而言可能是一個具轉型意義的機會。

We recently announced several updates for this program. First and foremost, we have recently completed enrollment in the Phase 2 portion of our Alzheimer’s disease psychosis program. And with this, we’ve tightened our range for top-line results, which we now expect to report in September to October.

我們近期公布了此計畫的多項更新。首先也是最重要的，我們最近已完成阿茲海默症精神病計畫第二期（Phase 2）部分的受試者收案。同時，我們也收斂了主要結果（top-line results）的公布時間區間，現預期將於 9 月至 10 月間發布。

At the same time, we announced receipt of Fast Track designation from the FDA. This designation underscores the substantial unmet need in Alzheimer’s disease psychosis, and we believe remlifanserin has the potential to become an important treatment option for patients and caregivers.

同時，我們也宣布已獲得 FDA 的快速通道（Fast Track）資格認定。此認定凸顯阿茲海默症精神病領域存在重大的未被滿足醫療需求；我們相信 remlifanserin 有潛力成為病患與照護者的重要治療選項。

Now that Phase 2 enrollment is complete, consistent with our operationally seamless Phase 2/Phase 3 program design, we have commenced screening and enrollment in the Phase 3 studies. Beyond remlifanserin in Alzheimer’s disease psychosis, our pipeline is robust and active with multiple studies underway today and several additional trial starts and data readouts expected over the next 18 months.

在第二期收案完成後，依循我們在營運上無縫銜接的第二期/第三期（Phase 2/Phase 3）計畫設計，我們已啟動第三期研究的篩選與收案。除 remlifanserin 用於阿茲海默症精神病外，我們的研發管線強健且活躍，目前有多項研究正在進行，並預期在未來 18 個月內啟動數項額外試驗並取得數據讀出。

Starting with the programs currently underway, first is our Phase 3 study of trofinetide ongoing in Japan. We continue to expect a readout between September and November. We’re planning a regulatory submission in 2027. We’ll share more details about our potential filing strategy after we’ve selected our commercialization partner for the Japanese market.

先從目前正在進行的計畫談起，第一項是 trofinetide 在日本進行中的第三期研究。我們仍預期將於 9 月至 11 月間取得讀出結果。我們規劃於 2027 年進行法規申請。在我們為日本市場選定商業化合作夥伴後，將分享更多關於潛在申請策略的細節。

Now for other clinical programs. For remlifanserin, we also have a Phase 2 study underway in Lewy body dementia psychosis. And as mentioned, the two Phase 3 studies in Alzheimer’s disease psychosis are now open for enrollment.

接著談其他臨床計畫。就 remlifanserin 而言，我們也在路易體失智症精神病（Lewy body dementia psychosis）進行第二期研究。如前所述，阿茲海默症精神病的兩項第三期研究目前也已開放收案。

We’re also advancing ACP-211 in a Phase 2 study in major depressive disorder. ACP-711 and ACP-271 are progressing through their respective Phase 1 programs. Beyond this, by the end of 2027, we expect to have initiated three additional Phase 2 or Phase 3 studies. We also expect four Phase 2 or Phase 3 readouts over that same period.

我們也正推進 ACP-211 在重度憂鬱症（major depressive disorder）的第二期研究。ACP-711 與 ACP-271 正分別推進其第一期計畫。此外，至 2027 年底前，我們預期將再啟動三項額外的第二期或第三期研究。在同一期間，我們也預期將取得四項第二期或第三期的讀出結果。

Of those, the readouts we have disclosed include the upcoming Phase 2 RADIANT results in Alzheimer’s disease psychosis and trofinetide in Japan, as well as ACP-211 in major depressive disorder. Together, this cadence of trial starts and readouts represents potential meaningful momentum across our pipeline. One final note before I hand over to Mark. We were very pleased to have achieved a positive CHMP opinion in the EU for trofinetide following the re-examination process.

其中，我們已揭露的讀出包括：即將公布的阿茲海默症精神病第二期 RADIANT 結果、日本的 trofinetide，以及重度憂鬱症的 ACP-211。整體而言，這樣的試驗啟動與讀出節奏，代表我們研發管線可能出現具意義的動能。在我把電話交給 Mark 之前，最後補充一點。我們非常高興在重新審查程序後，trofinetide 在歐盟獲得 CHMP 的正面意見。

This represents a significant win for patients with Rett syndrome across the EU and brings us one step closer to making this foundational therapy available to patients in Europe. We anticipate a final decision from the European Commission later in Q3, I’d like to thank the dedicated Acadians who worked so hard to achieve this outcome.

這對整個歐盟的雷特氏症（Rett syndrome）患者而言是一項重大勝利，也讓我們更接近在歐洲讓這項基礎性療法可供患者使用。我們預期歐盟執委會將於第三季稍晚做出最終決定；我也要感謝所有為達成此成果而努力不懈的 Acadia 同仁。

In summary, our R&D organization is executing at a high level across multiple programs, positioning us to deliver important milestones that have the potential to create value for both patients and shareholders over the long term.

總結來說，我們的研發組織在多項計畫上以高水準執行，讓我們有望交付重要里程碑，並在長期為病患與股東創造價值。

And with that, I’ll turn the call over to Mark to review our financial results.

接下來，我把電話交給 Mark，請他回顧我們的財務結果。

Thank you, Liz. And good afternoon, everyone. I’m pleased to report strong financial results for the second quarter of 2026 that reflect the robust commercial execution Tom and Catherine described earlier. Total revenues for the second quarter were $308 million, representing 17% year-over-year growth on an adjusted basis.

謝謝你，Liz。各位下午好。我很高興報告 2026 年第二季的強勁財務表現，反映了 Tom 與 Catherine 先前所描述的穩健商業執行。第二季總營收為 3.08 億美元；以調整後基礎計算，年增 17%。

DAYBUE delivered net sales of $125 million in the second quarter, up 30% year-over-year of which 27% came from volume. This exceptional volume growth was primarily driven by the strong uptake of the newly launched DAYBUE STIX formulation in the US. The gross-to-net adjustment for DAYBUE was 24.4% in the quarter.

DAYBUE 第二季淨銷售額為 1.25 億美元，年增 30%，其中 27% 來自銷量成長。這項卓越的銷量成長主要由 DAYBUE STIX 新劑型在美國上市後的強勁採用所帶動。本季 DAYBUE 的毛額轉淨額（gross-to-net）調整為 24.4%。

NUPLAZID generated net sales of $183 million in the second quarter, up 10% compared to the same period last year on an adjusted basis, driven by 8% volume growth, reflecting strong underlying demand for this important therapy. Our gross-to-net adjustment for NUPLAZID in the quarter was 23.9%.

NUPLAZID 第二季淨銷售額為 1.83 億美元；以調整後基礎計算，較去年同期成長 10%，其中 8% 由銷量成長帶動，反映此重要療法的強勁基本需求。本季 NUPLAZID 的毛額轉淨額（gross-to-net）調整為 23.9%。

Turning to operating expenses, our investments continue to be focused on advancing our pipeline and supporting our commercial growth. Research and development expenses for the quarter were $82 million, compared to $78 million a year ago. SG&A expenses were $160 million for the quarter, compared to $134 million a year ago. This increase reflects our investments to expand both the NUPLAZID and DAYBUE field forces and increased marketing investments supporting both brands.

談到營運費用，我們的投資仍持續聚焦於推進我們的研發管線並支持商業成長。本季研發費用為8,200萬美元，較去年同期的7,800萬美元增加。本季銷售、一般及行政（SG&A）費用為1.60億美元，較去年同期的1.34億美元增加。此增幅反映我們為擴大NUPLAZID與DAYBUE兩個品牌的銷售團隊所做的投資，以及支持兩個品牌的行銷投資增加。

We ended the quarter with a cash position of $956 million. This healthy cash balance provides us with the financial flexibility to execute on our commercial plans, advance our pipeline, and pursue business development opportunities that align with our strategic objectives.

本季結束時，我們的現金部位為9.56億美元。這項充裕的現金餘額為我們提供財務彈性，使我們能執行商業計畫、推進研發管線，並追求符合我們策略目標的業務發展機會。

Turning to our full year 2026 guidance, we’re raising our DAYBUE net sales outlook to $480 million to $510 million, up from $460 million to $490 million. This outlook reflects our strong performance in the first half of the year and includes all forms of trofinetide available globally, including our expectation for initial EU commercial sales in Q4.

接著談我們2026全年指引，我們將DAYBUE淨銷售額展望上調至4.80億至5.10億美元，高於先前的4.60億至4.90億美元。此展望反映我們上半年強勁的表現，並納入全球可取得之trofinetide的所有形式，包括我們對第四季在歐盟初期商業銷售的預期。

Our NUPLAZID net sales guidance remains unchanged at $760 million to $790 million. Taken together, we now expect total 2026 revenue of $1.24 billion to $1.3 billion. As we look to the rest of the year, let me provide a bit more color on expectation for each brand. For DAYBUE, we expect similar year-over-year growth rates for Q3 and Q4. And for NUPLAZID, we expect stronger year-over-year growth in Q4 relative to Q3 due to the greater impact of the expanded field force expected later in the year. Also for DAYBUE, we are slightly increasing the guidance range for gross-to-net to 23% to 25%.

我們對NUPLAZID淨銷售額的指引維持不變，為7.60億至7.90億美元。綜合而言，我們目前預期2026年總營收為12.4億至13.0億美元。展望今年剩餘時間，讓我就各品牌的預期補充一些說明。就DAYBUE而言，我們預期第三季與第四季的年增率將相近。至於NUPLAZID，我們預期第四季相較第三季將有更強的年增率，原因是擴編後的銷售團隊在今年稍晚將帶來更大的影響。另外，就DAYBUE而言，我們將毛利到淨額（gross-to-net）的指引區間小幅上調至23%至25%。

Lastly, on guidance, we are lowering our spend guidance for R&D and now expect R&D expenses in the range of $355 million to $380 million, compared to the prior guidance range of $385 million to $410 million. The reduction to R&D guidance is primarily attributable to the shifting of a BD milestone to 2027 and selected portfolio prioritization decisions. All other guidance ranges for fiscal year 2026 are unchanged. With that financial overview, I’ll turn the call back to Catherine for closing remarks.

最後，關於指引，我們下調研發支出指引，現預期研發費用介於3.55億至3.80億美元，先前指引為3.85億至4.10億美元。研發指引下調主要歸因於一項業務發展（BD）里程碑延後至2027年，以及部分產品組合優先順序調整的決策。2026會計年度其他各項指引區間均維持不變。以上為財務概述，接下來我把電話交回Catherine作結語。

Thank you, Mark. As we close, I want to reinforce why ACADIA is positioned for its next Phase of growth. Anchored by proven commercial execution, a transformational near-term pipeline opportunity, and multiple value-driving milestones ahead.

謝謝你，Mark。在結束前，我想再次強調為何ACADIA已為下一階段的成長做好定位。我們以經驗證的商業執行力為基礎，搭配具轉型性的近期研發管線機會，以及多項可驅動價值的里程碑即將到來。

Turning first to commercial execution, performance remains strong across both brands. We delivered an excellent second quarter led by DAYBUE. These results have led us to raise our DAYBUE guidance. Looking ahead, the upcoming European Commission decision represents another meaningful opportunity as we prepare to bring this foundational therapy to patients, beginning with our planned launch in Germany in the fourth quarter.

先談商業執行，兩個品牌的表現仍然強勁。我們交出亮眼的第二季成績，主要由DAYBUE帶動。這些結果促使我們上調DAYBUE指引。展望未來，即將到來的歐盟執委會決定代表另一個重要機會；我們正準備將這項基礎性療法帶給患者，並將從第四季計畫在德國上市開始。

NUPLAZID also continues to perform well, and we are beginning to see the benefits of our expanded field force as the team ramps and reaches more healthcare practitioners across specialties. Building on our commercial momentum, remlifanserin remains our most important near-term pipeline catalyst, with Phase 2 data in Alzheimer’s disease psychosis expected in the September to October timeframe.

NUPLAZID也持續表現良好，隨著團隊擴編並逐步到位、觸及更多跨專科的醫療照護從業人員，我們開始看到擴大銷售團隊所帶來的效益。在商業動能的基礎上，remlifanserin仍是我們近期最重要的研發管線催化劑，預期將於9月至10月期間公布阿茲海默症精神病（psychosis）的第二期數據。

Beyond remlifanserin, we’re advancing ACP-211 and our broader pipeline, with additional catalysts ahead, including top-line Phase 3 trofinetide data from Japan later this year. Finally, we remain guided by our mission to turn scientific promise into meaningful innovation for underserved communities.

除remlifanserin之外，我們也在推進ACP-211及更廣泛的研發管線，未來仍有更多催化劑，包括今年稍晚將公布日本trofinetide第三期試驗的主要（top-line）數據。最後，我們始終以使命為指引，將科學潛力轉化為對資源不足社群具有意義的創新。

Our second quarter performance and the milestones ahead reflect the progress we are making and reinforce our confidence in ACADIA’s next Phase of growth. Thank you all for your continued support of ACADIA. And with that, we’re happy to take your questions. Operator?

我們第二季的表現以及即將到來的里程碑，反映我們正在取得的進展，並強化我們對ACADIA下一階段成長的信心。感謝各位持續支持ACADIA。接下來，我們很樂意回答各位的問題。接線員？

Thank you. And we will now begin the question and answer session. (Operator Instructions)

謝謝。我們現在開始問答環節。（接線員指示）

Tessa Romero, J.P. Morgan.

Tessa Romero，摩根大通（J.P. Morgan）。

Hi, Catherine and team. Thanks so much for taking our questions this evening. So Liz, actually a question for you. Thinking through the outcome of the Phase 2 RADIANT trial, how should we think about scenarios around effect size here around your primary endpoint of the SAPS [H&D]? And how should we think about the lower bounds of what could still have a path forward into Phase 3? Or Put another way, how much room do you think you have in your data to be able to execute on a Phase 3 plan that is de-risked enough in ADP? Thank you.

嗨，Catherine和團隊。非常感謝今晚回答我們的問題。Liz，我其實有個問題想請教你。在思考第二期RADIANT試驗的結果時，我們應該如何看待主要終點SAPS [H&D]在效果量（effect size）方面的各種情境？以及我們應該如何看待仍可能有機會推進到第三期的效果下限？或者換句話說，你認為在你們的數據中，有多大的空間能夠在ADP上執行一個去風險程度足夠的第三期計畫？謝謝。

It’s a great question, Tess, and obviously one we’ve been giving a great deal of thought to, of what would be really Phase 3-enabling data. So I’ll make a few comments there. First off, as I’m sure everyone on this call knows by now, we are 80% powered for a moderate effect size, 0.4 effect size on our SAPS H&D.

這是個很好的問題，Tess，而且顯然也是我們一直投入大量心力思考的：什麼樣的數據才真正能支持進入第三期。我先做幾點說明。首先，我相信在這通電話上的各位現在都知道，我們在SAPS H&D上以中等效果量、也就是0.4的效果量，設計為80%的檢定力（powered）。

There is probably a little bit of flexibility around that in terms of what would still be a supportable and Phase 3 progressable asset. There is a lower level beyond which you start worrying about whether you’d be able to replicate the effect. So I think we’ve got a ways there.

在此之上，對於什麼仍可被支持、並可推進到第三期的資產，可能還有一些彈性。但也存在一個更低的水準，低於該水準你就會開始擔心是否能夠重現效果。因此我認為我們仍有一定的空間。

In general, we’re going to be looking certainly at the impact on SAPS at H&D, but that’s not going to be the only thing we’re going to look for at an effect size perspective. We’re going to look at responder analyses on SAPS H&D.

整體而言，我們當然會看SAPS H&D的影響，但從效果量的角度來看，這不會是我們唯一關注的項目。我們也會在SAPS H&D上進行反應者（responder）分析。

There are a number of other endpoints that we’re considering as well. But broadly speaking, we’re looking to see that we’ve got something that we think continues to align with what we think would be a meaningful drug in this space, and that’s something that’s going to be easy for patients to take, something they can take once a day with or without food, something that has evidence of efficacy, a supportive safety profile, and some of the stuff we won’t definitively answer in Phase 2, of course.

我們也在考量其他多個終點。但廣義而言，我們希望看到的是：我們所得到的結果仍與我們認為在此領域中「具有臨床意義的藥物」相一致；同時也要是患者容易服用的藥物，例如每日一次、可隨餐或不隨餐服用；並且要有療效證據、支持性的安全性概況，而其中有些面向當然無法在第二期就得到最終答案。

But we are going to want to feel good about the fact that we don’t have negative cognitive impact or negative impact on motor, things like that. So there’s a number of different considerations we’re going to be looking at, but that hopefully gives you a little bit of a flavor for the thinking. Thanks, Tess. Thanks.

但我們會希望對於沒有負面的認知影響、或沒有對運動功能造成負面影響等方面感到放心。因此我們會考量多個不同面向，但希望這些能讓你稍微了解我們的思考方向。謝謝你，Tess。謝謝。

Ritu Baral, TD Cowen.

Ritu Baral，TD Cowen。

Hi. Thanks, guys. Two questions. One is actually a follow-up to Tess’s and specifically, Liz, around the CGI-S. We had previously talked about how you intended to anchor the SAPS H&D to the CGI-S. Can you talk to what the MCID for CGI-S is, and if you’re going to release that data, and if there’s going to be sort of a correlative analysis with the top-line data with your data announcement?

嗨。謝謝，各位。兩個問題。第一個其實是延續 Tess 的問題，特別是，Liz，關於 CGI-S。我們之前談過你們打算如何將 SAPS H&D 錨定到 CGI-S。你能談談 CGI-S 的 MCID 是多少、你們是否會公布該數據，以及是否會在你們發布數據公告時，針對 CGI-S 與 SAPS H&D 的總體（top-line）數據做某種相關性分析嗎？

And second, could you speak a little more to some of the presentations that I saw -- that our team saw at IRSF around from the Delphi consensus? They talked a fair bit about improved tolerability. I believe it’s an independent group, but improved tolerability with STIX and improved DAYBUE tolerability with new titration regimens and how, what they presented at IRSF is making an impact on DAYBUE commercially. Thanks.

第二個，你能否再多談一些我看到——我們團隊在 IRSF 看到的——來自 Delphi 共識的一些簡報？他們相當多地談到耐受性改善。我相信那是一個獨立團體，但他們提到 STIX 的耐受性改善，以及透過新的滴定方案提升 DAYBUE 的耐受性，還有他們在 IRSF 所呈現的內容如何在商業層面影響 DAYBUE。謝謝。

I’ll take a shot at the first part, certainly, and then probably we’ll do some tag teaming on the second. With respect to some of the CGI-S and how we may use that. First and foremost, this is our key secondary endpoint. I will say, I guess I should start with level setting with expectations around what’s actually going to be put out at the time that we do our initial press release.

我先嘗試回答第一部分，當然，第二部分我們可能會一起接力補充。關於 CGI-S 以及我們可能如何使用它。首先也是最重要的，這是我們的關鍵次要終點。我想我應該先校準一下大家對於我們首次新聞稿發布時，實際會對外公布哪些內容的預期。

I think it’s probably best to think in terms of what’s going to be there for sure is going to be our primary efficacy endpoint and a comment on safety. Additional information, we’re going to determine whether that is necessary and helpful at that time, and some things we will certainly wait for future medical meetings. I would not anticipate that you’re going to see any kind of correlation analyses between CGI-S and SAPS H&D.

我認為最好這樣理解：一定會包含的是我們的主要療效終點，以及對安全性的評論。其他補充資訊，我們會在當時判斷是否必要且有幫助；有些內容我們肯定會留待未來的醫學會議再公布。我不預期你們會看到任何 CGI-S 與 SAPS H&D 之間的相關性分析。

I think when I referred to the anchoring before, what I was talking about is in the context of an eventual dossier to support the applicability of an endpoint for regulatory purposes. We do anticipate we would need to have a full dossier explaining the behavior of the instrument, the appropriateness of it, et cetera. So that is one path that we could take to help support that, is through an anchoring with the CGI-S.

我之前提到「錨定」時，指的是在最終用於支持某個終點具備監管用途適用性的申報資料（dossier）脈絡下。我們確實預期需要一份完整的 dossier，說明該量表工具的表現、其適切性等等。因此，我們可以採取的一條路徑，就是透過與 CGI-S 的錨定來協助支持這一點。

Generally speaking, it is considered that a change on CGI-S or CGI-I, that those in and of themselves are clinically meaningful, and so that’s helpful as you’re trying to define meaningful change on another instrument. I think that covered everything around the CGI-S.

一般而言，CGI-S 或 CGI-I 的變化本身就被視為具有臨床意義，因此當你試圖在另一個量表上界定「有意義的變化」時，這會很有幫助。我想這就涵蓋了關於 CGI-S 的所有內容。

With respect to some of the presentations at IRSF, taking the tolerability with titration piece first. What I will say is some of the information that we have from LOTUS has suggested over time that there, in patients who titrate, that you certainly don’t see onset of diarrhea with the same kind of rate. So that can give an opportunity for patients and families to get accustomed to the drug in context of many other tools that are in the toolbox.

至於 IRSF 的一些簡報，我先談滴定與耐受性那一塊。我要說的是，我們從 LOTUS 得到的一些資訊顯示，隨著時間推進，在進行滴定的患者中，你確實不會以同樣的發生率看到腹瀉的出現。因此，這能讓患者與家屬有機會在眾多可用工具的情境下，逐步適應這個藥物。

Things that we have encouraged physicians to make more use of is use of fiber, adequate water intake, making sure that they are discontinuing the antidiarrheals, et cetera. So there are a number of different tools that can help from a tolerability perspective. And I guess, Tom, I’ll let you comment on how that is impacting physician use.

我們也鼓勵醫師更多運用的一些做法包括：使用纖維、充足飲水、確保停用止瀉藥等等。因此，從耐受性的角度來看，有許多不同的工具可以提供幫助。我想，Tom，我讓你評論一下這對醫師使用行為的影響。

Sure. So just a couple of things I would say. So first off, in terms of the Delphi consensus reaches that you mentioned, yes, we did present a number of papers at IRSF. As a reminder, the Delphi consensus was actually conducted prior to the launch of STIX. So all of the information that you were seeing there relates to the oral solution.

好的。我想我會說幾點。首先，關於你提到的 Delphi 共識結果，是的，我們在 IRSF 發表了多篇論文。提醒一下，Delphi 共識其實是在 STIX 上市之前進行的。所以你在那裡看到的所有資訊都與口服溶液相關。

As it relates to STIX and the real experience that we’re seeing, what we would say is, at the moment, it seems to be on par with what we’ve seen historically with oral solution in terms of tolerability. Obviously, we’re learning more as we go, and this has only been the first full quarter where it’s been in the hands of patients and caregivers beyond COEs.

至於 STIX 以及我們目前看到的真實使用經驗，我們會說，就目前而言，它在耐受性方面似乎與我們過去對口服溶液的歷史觀察大致相當。當然，我們會在推進過程中持續學習，而且這也只是它在 COE 之外、真正交到患者與照護者手上的第一個完整季度。

But what I would say is we’ve been very encouraged by the early start that we’ve made with STIX and have been pleased with the momentum that we’re seeing across both COEs and non-COEs as we’ve moved into the community.

但我要說的是，我們對 STIX 早期的起步非常受到鼓舞，也對我們看到的動能感到滿意——無論是在 COE 或非 COE，隨著我們進入社區端都呈現出良好趨勢。

Ash Verma, UBS.

Ash Verma，瑞銀（UBS）。

Great. Thanks for taking our question. I’ve got two on ADP as well. Maybe since in the Phase 2, the effect size that you’re shooting for, the 0.4 that you mentioned about the powering. Just help us understand, the prior Study 019, I think, from data that had shown a 0.32, that was using a different NPI-NH scale but in RADIANT, you are using SAPS H&D, so is that effectively comparable or not, the effect sizes?

很好。謝謝讓我們提問。我也有兩個關於 ADP 的問題。或許先從第二期來看，你們提到在樣本數估算（powering）上目標的效應量是 0.4。請幫我們理解一下：先前的 019 研究，我記得數據顯示效應量約 0.32，那是使用不同的 NPI-NH 量表；但在 RADIANT 你們使用的是 SAPS H&D，所以這些效應量在本質上可比嗎，還是不可比？

And then secondly, saw that you started the Phase 3 screening and enrolling the patients already, but we are waiting the data from Phase 2. If you’re having to dose patients in the Phase 3 before we get the Phase 2 data, which dose would you be inclined to? Thanks.

第二，你們已經開始第三期的篩選並招募患者，但我們仍在等待第二期數據。如果在拿到第二期數據之前，你們就必須在第三期對患者給藥，你們會傾向選擇哪個劑量？謝謝。

I’ll just keep going. Okay. So with ADP, just to ground a little bit in the pimavanserin data. So Study 019 was the Phase 2 study of pimavanserin in ADP. It was, as you rightly note, using a different endpoint. There are other differences from a population perspective. In our current study, we are, of course, requiring biomarker confirmation, though I will say on balance, we expect that most patients who were in the 019 study probably would have been biomarker positive as they were fairly advanced in their disease course but we don’t actually have biomarkers to be able to confirm that.

我就接著回答。好的。關於 ADP，我先稍微回到 pimavanserin 的數據作為背景。019 研究是 pimavanserin 在 ADP 的第二期研究。如你正確指出的，它使用的是不同的終點。從受試者族群角度也還有其他差異。在我們目前的研究中，我們當然要求生物標記（biomarker）確認；不過我也要說，整體而言，我們預期 019 研究中的大多數患者可能會是生物標記陽性，因為他們的病程相對較晚期，但我們實際上沒有生物標記可用來確認。

And probably another important thing to keep in mind is one of the things that we have seen in the dataset is that there does appear to be a more significant impact in patients with greater baseline psychosis, and so in the RADIANT trial, we are looking to move that patient population on balance to a somewhat more severe psychosis population than was in Study 019.

另外一個可能很重要、需要記住的點是：我們在資料集中看到，在基線精神病性症狀較嚴重的患者身上，似乎會有更顯著的影響；因此在 RADIANT 試驗中，我們希望整體上把受試者族群往較嚴重的精神病性症狀族群移動，相較於 019 研究的族群更偏重症一些。

And so with that context, yes, the Phase 2 of pimavanserin did have an effect size of about 0.32. We did power for remlifanserin for 0.4 for a couple of reasons. One, of course, is the endpoint where we’ve changed to something that we think is more sensitive to change, but also the fact that we have enriched for that more severe psychosis population, which if you look in Study 019, actually, if you look in the severe psychosis population, your effect size goes up to more like 0.6.

在這樣的背景下，是的，pimavanserin 的第二期確實有大約 0.32 的效應量。我們為 remlifanserin 以 0.4 的效應量來進行樣本數估算，原因有幾個。第一，當然是終點的差異——我們改用我們認為對變化更敏感的量表；另外也因為我們針對較嚴重精神病性症狀族群做了富集（enriched），如果你看 019 研究，其實在重症精神病性症狀族群中，效應量會上升到更接近 0.6。

So we think that 0.4 is a defensible and appropriate powering assumption, and we think that if we meet that or in that vicinity, what we have is an agent that potentially could be meaningful for patients. And then I think the second piece was about Phase 3.

因此我們認為 0.4 是一個可辯護且適當的效能（powering）假設，而我們也認為如果我們達到該水準或接近該水準，我們所擁有的將是一種對病患可能具有實質意義的藥物。接著我想第二部分是關於第三期（Phase 3）。

So yes, the design of our study is operationally seamless. What that does mean is that once enrollment completed in the Phase 2 portion, which we did announce recently, sites were able to start screening and then enrolling for the Phase 3 portion.

所以是的，我們研究的設計在營運上是無縫銜接的。這代表一旦第二期（Phase 2）部分完成收案（我們最近也已宣布），各中心就能開始篩選，並接著為第三期部分進行收案。

Right now, our Phase 3s are designed very similarly to the Phase 2 study. The fact that these are statistically separate does mean we have the opportunity to analyze those data, which we are going to do in the September to October timeframe and share those data, but also make modifications to the Phase 3 as needed.

目前，我們的第三期試驗在設計上與第二期研究非常相似。由於這些在統計上是分開的，這表示我們有機會分析那些數據；我們將在 9 月到 10 月的時間範圍內進行並分享這些數據，同時也會視需要對第三期試驗做出調整。

Right now, we are enrolling for both dosing arms, so there would be placebo 30 and 60. There is a possible future where one of those dosing arms doesn’t need to be taken forward, but for now, we are continuing on with that.

目前我們正在為兩個劑量組別收案，因此會有安慰劑、30 與 60。未來可能出現其中一個劑量組別不需要再往後推進的情況，但就目前而言，我們會持續按此進行。

Thanks, Liz. It’s going to be the Liz show today. The next question will be --

謝謝，Liz。今天會是 Liz 的主場。下一個問題將會是--

Marc Goodman, Leerink Partners.

Leerink Partners 的 Marc Goodman。

Yes. Now that it looks like DAYBUE Europe is going to happen, can you help quantify that opportunity for us? You mentioned Germany in the fourth quarter. What other countries are you expecting to launch? And just give us a sense of how fast you think that ramp can be. Thank you.

是的。既然看起來 DAYBUE 在歐洲將會成真，你能幫我們量化一下那個機會嗎？你提到第四季在德國。你們預期還會在哪些國家上市？也請讓我們了解一下你認為那個爬坡速度會有多快。謝謝。

Sure. I’ll take that one, Marc. Thanks for the question. So first off, goes without saying that we are very pleased that we’ve been able to turn around a negative opinion into a positive outcome for patients in Europe. And as I mentioned in the preparatory remarks, the team are geared up and ready to go. So we anticipate EC decision by the end of Q3, as Liz mentioned, the team is going to be pretty quickly ready to go thereafter.

當然。Marc，我來回答這題。謝謝你的提問。首先，不言而喻，我們非常高興能夠把一個負面意見扭轉為對歐洲病患的正面結果。如同我在事先準備的發言中提到的，團隊已整裝待發、準備就緒。因此我們預期在第三季末獲得歐盟執委會（EC）的決定；如 Liz 所提到的，之後團隊將能很快開始推進。

Germany will be the launch market as we get out the gates, you would then follow the normal cadence that you’d expect to see in terms of other early launch markets in the EU, which tends to be Nordics and then others that we’re working through. Austria tends to be pretty quickly after Germany at the same time.

德國將是我們起跑後的首個上市市場，接著你會看到在歐盟其他早期上市市場的正常節奏，通常會是北歐國家，然後是我們正在推進的其他國家。奧地利通常也會在德國之後相當快、幾乎同時跟進。

In terms of the commercial opportunity, I go back to what we’ve shared previously, which is, as you look at the $700 million guidance for 2028, we estimate somewhere less than 15% of that number to come from Europe. So as you think about cadence for the launch, it will be somewhat gradual through the end of Q4, but as the patients who are receiving free drug today in Germany transition to paid treatment, and then you’ll see it consistently come online through next year.

就商業機會而言，我回到我們先前分享過的內容：以 2028 年 7 億美元的指引來看，我們估計其中不到 15% 會來自歐洲。因此在上市節奏方面，直到第四季末會是較為逐步的爬坡；但當目前在德國接受免費用藥的病患轉為自費（付費）治療後，你將會看到營收穩定上線並延續到明年。

So more information to come, but we’re excited by the opportunity. I think as you think about the three pillars of growth for DAYBUE into the future, international expansion in Europe is certainly one, and we’re really looking forward to pulling that through.

後續會有更多資訊，但我們對這個機會感到振奮。我認為，當你思考 DAYBUE 未來的三大成長支柱時，歐洲的國際擴張無疑是其中之一，我們也非常期待把它推進落地。

And just to sort of put a nail on that, Mark, as you know, it takes years for countries to come online in Europe, so we will continue to follow the path that Tom’s laid out. But also in the meantime, where we can supply physician demand through our named patient programs, we will be honoring that as well. So both of those things will be happening depending on the country and what’s going on and what the legal system allows. So just to continue that.

再補充一句，Mark，如你所知，在歐洲各國陸續上線往往需要多年時間，因此我們會持續依照 Tom 所規劃的路徑推進。同時，在我們能透過具名病患計畫（named patient programs）供應醫師需求的地方，我們也會持續履行供藥。因此，這兩件事會視各國情況、當地進展以及法律制度所允許的範圍而並行發生。以上補充。

Thanks.

謝謝。

Tazeen Ahmad, Bank of America.

美國銀行（Bank of America）的 Tazeen Ahmad。

Hi. Good afternoon. Thanks for taking my questions. To clarify, do you expect the discontinuation rate to change with the STIX formulation? And then secondly, on pricing in Europe for DAYBUE, on average, what percent of discount do you think you’ll have to take in the major European countries over time? Thanks.

嗨。下午好。謝謝回答我的問題。想確認一下，你們預期停藥率會因 STIX 劑型而改變嗎？第二個問題，關於 DAYBUE 在歐洲的定價，長期來看，你認為在主要歐洲國家平均需要給出多少百分比的折扣？謝謝。

Thanks, Tazeen. I’ll let Tom talk about STIX and the discontinuation rate.

謝謝你，Tazeen。我先請 Tom 談談 STIX 與停藥率。

Sure. So I think as we’ve been monitoring this STIX performance out of the gate, to date, as I mentioned earlier on, from the early data that we’re seeing, it seems to be performing fairly similarly to what we have seen with the oral solution historically. Obviously, what’s been very different though with the STIX launch is that we are now able to reengage patients who had previously discontinued the oral solution now that we have the new therapy.

好的。我想就我們在上市初期對 STIX 表現的監測而言，截至目前，如我先前提到的，從我們看到的早期數據來看，它的表現似乎與我們過去看到的口服溶液相當接近。不過，STIX 上市非常不同的一點是：現在我們能重新接觸那些先前已停用口服溶液、但因為有了新療法而可能回來的病患。

And it’s clear that patients and caregivers in particular, are willing to come back to DAYBUE given the efficacy that the brand offers. So we’re continuing to monitor closely. What I would say overall as you think about discontinuation rates, although we don’t talk about them publicly so much as we did before, is they are largely in line with what we’ve shared in prior quarters.

而且很明顯，病患，尤其是照護者，願意因為這個品牌所提供的療效而回到 DAYBUE。因此我們會持續密切監測。整體而言，談到停藥率，我想說的是，雖然我們不像以前那樣常在公開場合談論，但它們大致上與我們在前幾季分享的水準一致。

They remain under double digits. It remains very consistent. And as we see more patients move to the STIX therapy, and we’re seeing that adoption happen somewhat quicker than we anticipated, we’ll be sharing additional information on that.

它們仍維持在個位數（低於 10%）。也仍然非常一致。隨著更多病患轉用 STIX 療法，而且我們看到其採用速度比預期稍快，我們會分享更多相關資訊。

In terms of pricing in Europe, I think for now we’re not guiding or giving any indication to prices in Europe. We will keep you updated as we move through those discussions with the individual national reimbursement authorities, starting with Germany. And as you know, free pricing in Germany is for the first six months, and after that we’ll start our negotiation. So it won’t be until the middle of next year that we start talking about that.

至於歐洲的定價，我想目前我們不會提供指引或任何歐洲價格的暗示。我們會在與各國的國家級給付／償付主管機關（reimbursement authorities）逐一討論的過程中，持續向各位更新，並將從德國開始。如你所知，德國在前六個月是自由定價，之後我們將開始談判。因此要到明年年中我們才會開始談論這件事。

Yigal Nochomovitz, Citigroup.

花旗集團（Citigroup）的 Yigal Nochomovitz。

Hi. Great. Thank you. Actually, just one more on pricing. You just mentioned the free pricing for the first six months. After that, what happens? Is there an accrual period where you estimate the expected negotiated price and then once you get that price, then you move to the set price?

嗨。很好。謝謝。其實我還有一個關於定價的問題。你剛提到前六個月是自由定價。之後會發生什麼？是否會有一段應計期間（accrual period），你們先估計預期的談判價格，然後一旦拿到那個價格，就再切換到固定價格？

And then with regard, again, back to the ADP readout, I’m wondering if you could just speak to the statistical test. I know I think for the prior study for pimavanserin ADP. It was a t-test, but there was also in the PDP trial, you used MMRM. I’m just wondering if you could speak to those details. Thank you.

另外，回到 ADP 的讀出結果，我想請你談談統計檢定。我知道我想在先前 pimavanserin 的 ADP 研究中，使用的是 t 檢定，但在 PDP 試驗中，你們使用了 MMRM。我只是想請你談談這些細節。謝謝。

I’ll get Tom to talk about the analog discussion, and then Liz can move on.

我會請 Tom 來談談關於學名藥的討論，接著 Liz 再繼續。

Yeah. So thanks for the question, Miguel. Regarding Germany, as soon as we have the approval, obviously, we’ll be launching in Germany, as we said. During that free pricing period, essentially per the legislation that exists in Germany, we have the ability to price as we wish.

是的。Miguel，謝謝你的提問。關於德國，一旦我們取得核准，顯然我們就會如先前所說在德國上市。在自由定價期間，基本上依據德國現行法規，我們可以依自己的意願定價。

At the same point, we will be working with AMNOG directly because we’ll have submitted our pricing reimbursement dossier, and that actually begins the process of negotiating what the price then becomes post that six month free pricing period. At which point, that becomes the price that’s recognized on a GTN basis.

同時，我們會直接與 AMNOG 合作，因為我們將提交定價與給付（報銷）資料檔案，而這也會啟動在六個月自由定價期之後，協商最終價格的流程。屆時，該價格會以 GTN 基礎被認列。

So essentially, because for that first six months, we recognize the revenue at full price, whatever it may be sets at. And then post that six month moratorium, that’s when we start recognizing a different price from the publicly available price that you would see.

所以基本上，因為在最初六個月內，我們會以全額價格認列營收，無論當時設定的價格是多少。而在六個月的暫緩期之後，我們就會開始以不同於你在公開可得價格中看到的價格來認列。

We haven’t talked a lot about the statistical considerations in terms of the Phase 2 study, but what I can say is that it is an MMRM analysis, and we are controlling for multiplicity, as you would anticipate with a pre-specified hierarchy.

我們並未大量談到第二期研究在統計上的考量，但我可以說的是，這是一個 MMRM 分析，而且我們如你所預期，會依預先指定的階層式檢定來控制多重性。

Got it. Thank you.

了解。謝謝。

Malcolm Hoffman, BMO Capital Markets.

BMO Capital Markets 的 Malcolm Hoffman。

Hi. Thanks for taking our question, and congrats on the quarter. I was wondering if you could provide any color on whether you have seen a normalization of typical refill rates for NUPLAZID. I know you had mentioned new patient starts are really strong, just wanted to get a sense whether recurring scripts are back on track. And then for remlifanserin, can you comment on whether you have had to correct for any rater drift throughout the study? I know maintaining the consistency of the rating throughout the trial is pretty critical here. Thanks.

嗨。謝謝讓我們提問，也恭喜本季表現。我想請教你們是否看到 NUPLAZID 典型的續配率已回到常態，有沒有一些補充說明。我知道你們提到新病人起始用藥非常強勁，只是想了解重複處方是否已回到正軌。另外，關於 remlifanserin，你們能否評論在研究期間是否需要針對評分者漂移（rater drift）做任何校正？我知道在整個試驗中維持評分一致性在這裡非常關鍵。謝謝。

We’ll get Tom to start on NUPLAZID.

我們先請 Tom 談談 NUPLAZID。

Sure. So yes, NUPLAZID referral and restart rates are exactly where we expected them to be. In fact, if we look at Q2 of 2026 versus Q2 of 2025 in historical years, there’s actually been a particularly good rebound versus prior years.

好的。是的，NUPLAZID 的轉介與重新啟用（restart）比率正如我們預期。事實上，如果我們看 2026 年第二季相較於 2025 年第二季的歷史年度表現，反彈幅度其實特別不錯。

So I think the phenomenon that we saw in Q1 of this year clearly does seem to have been a one-off. Obviously, we’ll be monitoring very closely as we end 2026. Everything, as it relates to demand and pull-through and patients returning, is exactly where we anticipated it to be.

所以我認為我們在今年第一季看到的現象，確實看起來是一次性的。當然，隨著 2026 年接近尾聲，我們會非常密切地監測。所有與需求、拉動效應（pull-through）以及病人回流相關的指標，都完全符合我們的預期。

And as far as commenting on rater evaluation, potential for rater drift, et cetera. We have tried to be mindful of that. We have a rigorous process, well, back in the day, for our site and our rater selection, including proven experience in these kinds of trials and psychosis assessments. We have extensive training, calibration exercises, and some standardized scoring protocols. But probably most relevant to your question, we are on an ongoing basis looking at blinded data and having sort of booster training of raters based on review of blinded data on an as-needed basis.

至於評分者評估、評分者漂移的可能性等等，我們一直很留意。我們有一套嚴謹的流程（嗯，以前就如此）來進行研究中心與評分者的遴選，包括在這類試驗與精神病性症狀評估方面具備經驗的證明。

Thanks for the question, Malcolm.

謝謝你的提問，Malcolm。

Ami Fadia, Needham & Company.

Needham & Company 的 Ami Fadia。

Hearing no response, we will move to the next question. Our next question comes from the line of Sean Loman with Morgan Stanley. Your line is open.

沒有聽到回應，我們將進入下一個問題。下一題來自 Morgan Stanley 的 Sean Loman。你的線路已開通。

Good afternoon, Catherine and team. Thanks for taking my question. Hope everyone’s well. On DAYBUE STIX, clearly an acceleration there, can you quantify how much of the recent demand reflects entirely new patients versus improved compliance, persistence, or conversion from the oral formulation? Where do you estimate the current treated patient population penetration stands in the US and how much untreated or underdiagnosed opportunity remains? Thank you.

各位下午好，Catherine 與團隊。謝謝讓我提問。希望大家都一切安好。關於 DAYBUE STIX，顯然有加速成長；你們能否量化近期需求中，有多少完全來自全新病人，多少來自依從性、持續用藥（persistence）的改善，或由口服劑型轉換而來？你們估計目前在美國的治療病人滲透率大約是多少？仍有多少未治療或未被充分診斷的機會？謝謝。

Hi, Sean. It’s Tom. So thank you for the question. So let me just provide a little more color on the dynamics that we saw in the quarter. So if you look at our overall mix in the quarter, both across STIX and the oral solution. Around 60% of our referrals were coming from naive patients, 40% were returning patients. So as we think about, again, future growth potential for the brand, obviously naive will remain a focus. I think with STIX, we now have this additional opportunity to engage patients who had previously just discontinued.

嗨，Sean。我是 Tom。謝謝你的問題。我先補充一些本季我們看到的動態。如果你看本季我們整體組合，包含 STIX 與口服溶液。大約 60% 的轉介來自未曾治療（naive）的病人，40% 來自回流病人。因此在思考品牌未來的成長潛力時，顯然未曾治療病人仍會是重點。我認為有了 STIX，我們現在也多了一個機會去接觸那些先前已停用的病人。

When we look at STIX in isolation, it’s interesting there that we saw 55% of our existing patients were switching from oral solution, 45% were either new or returning. So that gives you a little more flavor. We’ve also been particularly encouraged by just the momentum that we’ve seen through the quarter. So if we take June in isolation and we look across the entire business, 60% of all of our referrals in June alone was the STIX formulation.

如果單看 STIX，本季也很有意思：我們看到 55% 的既有病人是從口服溶液轉換過來，45% 則是新病人或回流病人。這能讓你更了解一些細節。我們也特別受到鼓舞的是，我們在整個季度看到的動能。如果單看 6 月，並觀察整體業務，僅 6 月份我們所有轉介中有 60% 都是 STIX 劑型。

So I think that that gives you a very clear direction of travel as we think about just the uptake of STIX, the positive reaction that we’ve seen from both the clinical community and the patient community. We had a very strong IRSF meeting, and I think the momentum that we’re building gives us a real sense of confidence that we can finish this year strong and really build further as we think about 2027.

所以我認為，這非常清楚地顯示了我們在思考 STIX 的採用速度時的發展方向，以及我們從臨床社群與病人社群看到的正面反應。我們在 IRSF 會議上表現非常強勁，我認為我們正在建立的動能，讓我們很有信心今年可以強勢收尾，並在展望 2027 時進一步擴大成長。

Thank you, Tom. Much appreciated.

謝謝你，Tom。非常感謝。

Thank you.

謝謝。

Next question.

下一題。

Brian Abrahams, RBC Capital Markets.

RBC Capital Markets 的 Brian Abrahams。

Hi, team. This is Kevin on for Brian. Thank you for taking our questions. So maybe just one on the DAYBUE opportunity in Japan. Can you remind us maybe what the Phase 3 trial design is there, and what efficacy endpoints those regulators might require? And then just what the addressable Rett syndrome population is in Japan. Thank you.

嗨，各位。我是 Kevin，代 Brian 發問。謝謝讓我們提問。我想問一題關於 DAYBUE 在日本的機會。你們能否提醒我們日本那邊第三期試驗的設計是什麼，以及監管單位可能會要求哪些療效終點？另外，日本可觸及的 Rett 氏症候群族群規模是多少？謝謝。

We’ll start with the addressable, and then we’ll move to Liz just to give her an opportunity to take a breath. Japan, we’re looking to commercialize after we get our registrational study completed, which Liz can give you details on.

我們先從可觸及族群規模開始，然後再交給 Liz，讓她也有機會喘口氣。日本方面，我們計畫在完成註冊性研究後進行商業化，Liz 可以提供相關細節。

The epidemiology of Rett around the world is similar. It’s one in 10 to one in 15,000 live female births. We believe there’s around 1,000 patients in Japan who have Rett syndrome. Various different sources give slightly different numbers, but it’s around that. And we’re looking forward to our Phase 3 trial, which Liz can give you a little bit of a description on.

Rett 的全球流行病學相近。大約是每 10,000 到 15,000 名女性活產嬰兒中有 1 名。我們相信日本約有 1,000 名 Rett 氏症候群病人。不同資料來源的數字略有差異，但大致在這個範圍。我們也很期待第三期試驗，Liz 可以再為你稍作說明。

It is a bit atypical as Phase IIIs go. I think it’s important to think of this in context of through discussions with PMDA. The primary support for an eventual indication, should we get there, is going to be our LAVENDER data.

就第三期試驗而言，這有點不太典型。我認為重要的是，要把這放在與 PMDA 討論的脈絡下來看。若我們最終能走到取得適應症那一步，主要的支持將會是我們的 LAVENDER 數據。

The Phase 3 study that we’re running in Japan is primarily to give some experience in Japanese patients. It is a very small trial. Think on the order of 20 patients-ish. There is a placebo control, but obviously it is in a very small number. Again, we’re looking at week 12 endpoints. We are looking at the same kinds of endpoints that we looked at in the trofinetide global program. Here, though, it is CGI-I as the primary with RSBQ as a key secondary endpoint. But again, the intent here is more to get experience in the Japanese population.

我們在日本進行的第三期研究，主要是為了在日本患者中累積一些使用經驗。這是一個非常小型的試驗。大概是 20 位左右的患者規模。有安慰劑對照，但顯然樣本數非常少。同樣地，我們看的是第 12 週的終點。我們評估的終點類型，與我們在 trofinetide 全球計畫中所看的相同。不過在這裡，主要終點是 CGI-I，而 RSBQ 是關鍵次要終點。但再次強調，這裡的目的更多是為了在日本族群中取得使用經驗。

There’s no expectation that we would be able to hit a P value, for example, with this kind of trial. So -- it will give us some sense of how the drug behaves there, and we think will be hopefully supportive for what is primarily going to be a LAVENDER-based package.

我們並不預期以這種試驗設計能夠達到例如 P 值顯著。因此——它會讓我們對藥物在當地的表現有一些了解，我們也希望它能對主要以 LAVENDER 為基礎的申報資料包提供支持。

Liz?

Liz？

Thank you very much.

非常感謝。

Sumant Kulkarni, Canaccord Genuity.

Sumant Kulkarni，Canaccord Genuity。

Good afternoon. Thanks for taking our questions. I have two, one on remlifanserin and one on peak sales potential. So it looks like Bristol’s enrollment for ADEPT of KarXT ADP is going somewhat slower than that company initially expected. Given your experience with the ongoing ADP trial, do you think that pace is something specific to their program, or does it have wider implications for other ADP programs, including yours?

下午好。感謝回答我們的問題。我有兩個問題，一個關於 remlifanserin，另一個關於峰值銷售潛力。看起來 Bristol 的 KarXT ADP 的 ADEPT 試驗收案進度比該公司最初預期的要慢一些。以你們在進行中的 ADP 試驗經驗來看，你們認為這個速度是他們計畫特有的情況，還是對其他 ADP 計畫（包括你們的）也有更廣泛的意涵？

Probably should be careful on how much I’m speculating on somebody else’s program. But I guess what I’d comment on there is essentially we took a while in enrollment because we were looking to make sure we were enrolling the right patient population. I think that anybody who is considering trials in this space should be thoughtful about how they are enrolling their patient population and ensuring that they have the patients enrolled that they’re looking to. So one of our versions there, of course, is the biomarker confirmation, but overall, we are being careful in that.

我可能需要小心一點，不要對別人的計畫做太多揣測。但我想我可以評論的是：我們在收案上花了一些時間，因為我們希望確保納入的是正確的患者族群。我認為任何考慮在這個領域做試驗的人，都應該審慎思考如何收案，並確保納入的是他們想要的患者。因此我們其中一個做法當然是生物標記確認，但整體而言，我們在這方面是很謹慎的。

Got it. Given where you are today with your solid performance in NUPLAZID, and you have now European approval for DAYBUE, do you have anything to add relative to your earlier $1.7 billion in peak global net sales in 2028 for those products?

了解。以你們目前 NUPLAZID 的穩健表現，以及 DAYBUE 現在已獲得歐洲核准來看，對於你們先前提出的 2028 年這些產品全球淨銷售峰值 17 億美元，你們有沒有什麼補充？

I think we’re talking about our confidence now of hitting those numbers as we move through the end of this year and we look at the continued uptake of DAYBUE STIX and we see how NUPLAZID ends the year. We will revisit that at that time. But for right now, both for the $1 billion on NUPLAZID and the $700 million on DAYBUE, we are confident that we will achieve those numbers during 2028.

我想我們現在談的是：隨著今年接近尾聲、我們觀察 DAYBUE STIX 的持續採用情況，以及看看 NUPLAZID 年底的表現，我們對達成那些數字的信心。我們會在那個時點再重新檢視。但就目前而言，無論是 NUPLAZID 的 10 億美元，或 DAYBUE 的 7 億美元，我們都有信心在 2028 年達成這些數字。

Thank you.

謝謝。

Rudy Li, Wolfe Research.

Rudy Li，Wolfe Research。

Hey, thanks for taking my question and congrats on a strong quarter for DAYBUE. Maybe just a quick follow-up to the patient dynamic for the STIX formulation. Can you maybe talk about the trend moving into July and August across different patient segments? And another question based on your recent market research and physician feedback, how should we think about the market dynamic for Rett syndrome with potential gene therapies in the coming years? Thank you.

嗨，謝謝讓我提問，也恭喜 DAYBUE 這一季表現強勁。我想快速追問一下 STIX 劑型的患者動態。你們能否談談進入 7 月與 8 月後，不同患者分群的趨勢？另外，根據你們近期的市場研究與醫師回饋，對於未來幾年可能出現的基因療法，你們認為 Rett 症候群的市場動態應該如何看待？謝謝。

Yeah. I’m going to ask Tom to talk about July and August then talk about our view on gene therapy.

好的。我會請 Tom 先談 7 月和 8 月的情況，然後再談我們對基因療法的看法。

Yeah. So a few things I would say, and thanks for the question, is as you look at the momentum that we saw during Q2, as I mentioned, 60% of our prescriptions at the end of June were already for STIX. And we are really now beginning to focus our team’s efforts beyond the COEs as we think about pushing STIX more broadly.

好的。我想說幾點，也謝謝你的問題：當你看我們在第二季看到的動能時，如我提到的，6 月底時我們 60% 的處方已經是 STIX。而我們現在也開始把團隊的重點從卓越中心（COEs）延伸出去，思考如何更廣泛地推動 STIX。

We feel pretty confident that the momentum that we saw during Q2 is going to continue into Q3. Early signs are indicating that way. In addition to all of the additional programs that we have outside of the US for inbound requests from inpatient sales as well.

我們相當有信心，第二季看到的動能會延續到第三季。早期跡象也顯示確實如此。此外，我們在美國以外也有更多計畫，包含來自住院端銷售的主動詢問（inbound requests）。

So I think as you take that together, this gives us confidence in the guidance that we shared. Obviously, we have lifted both the bottom and the top as we think about the end of this year. We feel good about where we’re situated as we think about the remaining five months of 2026.

所以我認為綜合來看，這讓我們對我們所分享的財測指引更有信心。很明顯地，當我們看今年年底時，我們已同時上調了下限與上限。在思考 2026 年剩下五個月時，我們對目前的態勢感到樂觀。

And in terms of gene therapy, just as a top line, we don’t see any impact to our commercial forecast either in the short or long term with the potential introduction of a gene therapy. While we welcome any new option for patients with Rett syndrome, we believe that DAYBUE will remain the standard of care for patients with Rett syndrome, both in the US and globally.

至於基因療法，先講結論：無論短期或長期，我們都不認為潛在基因療法的導入會對我們的商業預測造成任何影響。雖然我們歡迎 Rett 症候群患者有任何新的治療選項，但我們相信 DAYBUE 仍將是 Rett 症候群患者的標準治療（standard of care），不論在美國或全球皆然。

Tom, I don’t know if you want to talk any more about that.

Tom，我不確定你是否還想再補充一些。

I think obviously we’re watching with a keen interest these first-generation gene therapies. I think there’s optimism amongst certain patient types and certain members of the treating community. But again, we believe in the foundational standard of care that DAYBUE offers, obviously, it can be used either pre or post gene therapy.

我想很明顯地，我們正以高度關注在觀察這些第一代基因療法。我認為在某些患者類型以及部分治療社群成員之間，確實存在樂觀情緒。但再次強調，我們相信 DAYBUE 所提供的基礎性標準治療地位；而且它顯然可以在基因療法之前或之後使用。

We think that that inherent flexibility and the fact that you can use DAYBUE, it’s completely reversible. We know the profile of the treatment very closely, that DAYBUE will remain an important treatment for Rett syndrome moving forward. So I think the advent of DAYBUE STIX, I suggest makes us even more confident in that fact.

我們認為這種內在的彈性，以及你可以使用 DAYBUE、且它是完全可逆的這一點。我們非常了解這個治療的特性，因此 DAYBUE 未來仍會是 Rett 症候群的重要治療選項。所以我認為 DAYBUE STIX 的到來，讓我們對這一點更加有信心。

Thank you for the question.

謝謝你的提問。

David Huang, Deutsche Bank.

David Huang，德意志銀行（Deutsche Bank）。

Hi there. Thanks for taking my questions and congrats on the quarter. I want to ask about the development of remlifanserin in ADP versus Lewy body. Is there any reason to think that probability of success would be different between those two indications?

你好。謝謝回答我的問題，也恭喜本季表現。我想問 remlifanserin 在 ADP 相較於路易氏體（Lewy body）方面的開發。有沒有任何理由認為，這兩個適應症之間的成功機率會有所不同？

And then on the commercial side, I know you’ve talked about the $4 billion peak sales number there for remlifanserin across indications. Directionally, how should we think about how that might break out between ADP and Lewy body?

另外在商業面，我知道你們談過 remlifanserin 跨適應症的 40 億美元峰值銷售數字。就方向性而言，我們應該如何看待 ADP 與路易氏體之間可能的拆分？

Alright. I’ll let Liz start on that one. I’ll come up behind.

好。我先請 Liz 來回答這題。我再接著補充。

Yeah. I was so busy writing things down, I may have missed the second half of the question. So broadly speaking, we are enthused about both the possibility in Alzheimer’s as well as in Lewy body. These are both areas with tremendous unmet need and really nothing available for these patients.

是的。我忙著把內容記下來，可能漏聽了問題的後半段。總體而言，我們對阿茲海默症以及路易氏體這兩個領域的可能性都感到振奮。這兩個領域都有極大的未被滿足需求，而對這些病患而言幾乎沒有可用的治療選項。

In broad terms, I don’t think we see the probability as wildly different across the two. We have more data in Alzheimer’s with pimavanserin, certainly, but the data that we do have in Lewy body, though in a smaller number of patients, is pretty striking in its magnitude. So we’re looking forward to the first readout coming September to October, while we haven’t disclosed the Lewy body readout, we are looking forward to that in the future as well.

概括來說，我不認為我們看到兩者之間的成功機率有天壤之別。當然，我們在阿茲海默症的 pimavanserin 上有更多數據，但我們在路易氏體方面所掌握的數據，雖然病患數較少，其效果幅度相當顯著。因此，我們期待在 9 月到 10 月之間迎來第一個讀出；至於路易氏體的讀出時間我們尚未揭露，但我們也同樣期待未來能看到。

I think in terms of the commercial opportunity we’ve described before, and so have many others, the size of these markets, which are both considerable in the US and beyond. I think in terms of how we see the $4 billion split out, I would say it’s roughly 60% ADP, 40% Lewy body. Obviously, that highly depends on the data, the competitive frame, and who else is also on the market at the same time. So I would say we’re roughly around 60/40, but that will evolve as we get there. And let’s cross the data threshold first.

就我們先前描述過的商業機會而言（許多其他人也有類似看法），這兩個市場的規模都相當可觀，涵蓋美國及海外。就我們如何看待 40 億美元的拆分，我會說大約是 60% 來自 ADP、40% 來自路易氏體。當然，這高度取決於數據、競爭態勢，以及同一時間還有哪些產品也在市場上。所以我會說大致是 60/40，但隨著我們逐步推進，這個比例會演變。而且我們先跨過數據門檻再說。

And with that, we’ll take the next question.

接下來我們進入下一個問題。

Jack Allen, Baird.

Jack Allen，Baird。

Hi, everyone. Thanks for taking my questions. This is Chris on for Jack. Just turning back to DAYBUE. Regarding the STIX uptake, I heard you just mention that 45% of STIX users were either new or returning. Can you provide what percentage of that 45% were new? And are you seeing higher rates of uptake in a certain patient demographic, age, for example? If so do you see that changing over time? Thank you.

各位好。謝謝讓我提問。我是 Chris，代 Jack 提問。回到 DAYBUE。關於 STIX 的採用情況，我聽到你剛提到 STIX 使用者中有 45% 是新用戶或回流用戶。你能否提供在這 45% 當中，新用戶占比是多少？另外，你們是否看到在某些病患族群（例如年齡）有更高的採用率？若是如此，你們認為這種情況會隨時間改變嗎？謝謝。

Yeah. So as you think about the 45% that I mentioned, if you zoom in on STIX, it is roughly 60% were new, 40% were returning that we saw in the quarter. Again, as we go further into community, we anticipate that those dynamics may shift. It’s notable that we actually saw a very significant shift in Q2 to community prescriptions versus what we saw in Q1, which you’d expect because obviously that’s when we were actually talking to STIX more broadly beyond just the Centers of Excellence.

好的。就我提到的 45% 而言，如果聚焦在 STIX，該季度我們看到大約 60% 是新用戶、40% 是回流用戶。同樣地，隨著我們更深入社區端，我們預期這些動態可能會改變。值得注意的是，我們在第二季看到社區處方相較第一季出現非常顯著的轉移，這也符合預期，因為那正是我們開始在卓越中心之外、更廣泛地與 STIX 溝通的時點。

In terms of returning patients, we are seeing a very diverse mix. One of the things that has been different to what we had assumed before we launched is that it would primarily be patients who had discontinued due to formulation concerns that would return to the brand.

就回流病患而言，我們看到的組成非常多元。有一點與我們上市前的假設不同：我們原本以為主要會是因為劑型疑慮而停用的病患回到這個品牌。

We’re actually seeing that a far broader group of patients are willing to return, which again, I think just talks to the community’s interest in trying DAYBUE again based upon the efficacy that they know that patients can see with this treatment. And I think the new formulation will potentially give us an avenue to unlock that opportunity further.

但我們實際上看到願意回流的病患族群更為廣泛；我認為這也反映出社群對於基於既有療效、再次嘗試 DAYBUE 的興趣，因為他們知道病患使用這項治療能看到效果。而我認為新的劑型可能會為我們提供一條途徑，進一步釋放這個機會。

Ananda Ghosh, H.C. Wainwright.

Ananda Ghosh，H.C. Wainwright。

Hi, thanks, guys, and congrats on the quarter. I have two questions on ADP. The first one is, where do enrolled patients of RADIANT sit compared to prior trials as mentioned, like the Ballard et al paper, and what instrument was chosen on that criteria?

嗨，謝謝各位，也恭喜本季表現。我有兩個關於 ADP 的問題。第一個是：如先前提到的 Ballard 等人的論文等既往試驗相比，RADIANT 納入的受試者處於什麼樣的位置？以及基於哪些標準選用了哪一個量表？

The second follow-up question is, we noted that Study 019 was using NPI-NH both for screening as well as on the endpoint determination. But the RADIANT, I think, the screening tool is different than the endpoint, what’s the rationale behind that?

第二個追問是：我們注意到 019 試驗在篩選以及終點判定上都使用 NPI-NH。但在 RADIANT 中，我認為篩選工具與終點不同，這背後的理由是什麼？

So Anand, the first part of your question was a little bit unclear. So maybe we’ll get to start the Study 019 response, and then you can re-ask it so that we can answer the right question.

所以 Anand，你問題的第一部分有點不太清楚。也許我們先從 019 試驗的回覆開始，然後你再重新提問一次，這樣我們才能回答到正確的問題。

Sure. So what I’ll say is on the screening criteria that we used, let me phrase this carefully. So when we are considering patients that we’re including in the analysis, we’re taking into account both the [NPI-NH] values as well as the SAPS H&D values in terms of who qualifies for the primary analysis. So we are actually including a component of the endpoint as well as another criterion. And again, the goal here is to edge up that overall population level psychosis severity, because we do think that slightly more severe patient population does seem to have a greater effect size that’s shown.

好的。我想先說的是，我們使用的篩選標準——我會謹慎措辭。當我們考量納入主要分析的病患時，我們同時把 [NPI-NH] 的數值以及 SAPS H&D 的數值納入考量，以判定誰符合主要分析資格。因此，我們實際上納入了終點的一個組成部分以及另一項標準。同樣地，這裡的目標是把整體族群層級的精神病性症狀嚴重度往上推一些，因為我們確實認為，從既有顯示來看，稍微更嚴重的病患族群似乎會有更大的效果量。

I think the first part of the question was around enrolled patients, perhaps you could just ask it again so we can understand it properly.

我想第一部分的問題是關於已入組的病患；也許你可以再問一次，讓我們能正確理解。

Yeah. No, that was helpful. So I think this answers a part of that question. My question was, given that one of the ideas from the Study 019 was that you need to have much more severe patients. So given the baseline of RADIANT, where do they sit with respect to the overall Study 019 population? That was the question.

好的。不，那很有幫助。我想這回答了其中一部分。我的問題是：鑑於 019 試驗的一個觀點是需要更嚴重的病患，那麼以 RADIANT 的基線來看，他們相對於整體 019 試驗族群處於什麼位置？這就是我的問題。

Got it.

了解。

So we’re not at this point disclosing what baseline characteristics of the population look like. So what I can say is we did have enrollment criteria that should be consistent with edging up that overall population level severity. We’re not currently disclosing what the actual baseline values are.

目前我們不會揭露該族群的基線特徵長什麼樣子。我能說的是，我們確實設定了入組標準，應可與把整體族群嚴重度往上推的目標一致。我們目前不會披露實際的基線數值。

Thanks for the question, Anand.

謝謝你的提問，Anand。

Wee Ir, Mizuho.

Wee Ir，Mizuho。

Hey, guys. Congrats on the quarter, and thanks for taking our question. Just going back to the RADIANT study, I was wondering if you can provide a little more color in terms of the number of patients enrolled and whether all the patients have been dosed and what are the gating factors, I guess, to getting the data in September versus October. And my second question is, are you able to share for which program the milestone payment in R&D was shifted to 2027? Thanks.

嗨，各位。恭喜本季表現，也謝謝讓我們提問。回到 RADIANT 研究，我想請你們提供更多細節：入組病患人數大概是多少、是否所有病患都已給藥，以及我想所謂的關鍵因素是什麼，會決定數據是在 9 月還是 10 月取得。第二個問題是：你們能否分享研發費用中的里程碑付款被延後到 2027 年，是針對哪一個計畫？謝謝。

Sure. So again, hopefully I got all my notes down here. In terms of complete enrollment in the RADIANT program and in particular in the Phase 2 portion of it, that was 363 patients that were enrolled. The main gating factor between September and October is going to be the 30-day safety follow-up if patients don’t roll over. The study is still ongoing. Everybody has gotten past randomization, but there are still patients on study. So I cannot answer today whether all patients are going to go into the open label extension or whether we may need that 30-day follow-up, which would move us out later.

好的。再次希望我把筆記都記下來了。就 RADIANT 計畫、特別是其中第二期部分的完整入組而言，共入組了 363 名病患。9 月與 10 月之間的主要關鍵因素，將是若病患未轉入延伸試驗時所需的 30 天安全性追蹤。該研究仍在進行中。所有人都已完成隨機分派，但仍有病患在試驗中。因此，我今天無法回答是否所有病患都會進入開放標籤延伸試驗，或我們是否需要那 30 天追蹤，這將使時間點往後延。

In terms of the milestone question. So as we’ve been progressing ACP-711 forward, one of the things that we’ve been pleased, actually, is from a non-clinical perspective, we found that we both have the ability from a tox perspective and also the potential benefit of higher dosing.

就里程碑的問題而言。隨著我們持續推進 ACP-711，其中一件讓我們感到欣慰的事情其實是，從非臨床角度來看，我們發現無論是從毒理（tox）的角度，還是更高劑量可能帶來的潛在效益，我們都具備相應的能力與空間。

And so accordingly, we added in some additional higher dosing that we’re going to be exploring in Phase 1 before we go into Phase 2. That did shift out our timing a little bit such that the milestone’s not going to hit this year. I do look forward to updating more with some specifics around timelines and study impact as we get through that Phase 1 dosing. But we wanted to reflect reality of when we thought milestone would hit.

因此，我們在進入第 2 期之前，於第 1 期中新增了一些我們將要探索的更高劑量。這確實使我們的時程稍微往後移，因此該里程碑今年不會達成。隨著我們完成第 1 期劑量探索，我也期待能就時程與研究影響提供更具體的更新。但我們希望反映我們對里程碑達成時間點的現實判斷。

That’s great. Thanks, Liz.

太好了。謝謝你，Liz。

Paul Matteis, Stifel.

Paul Matteis，Stifel。

Hey, how’s it going? Thanks so much for taking our questions. This is Julian on for Paul. In thinking about DAYBUE STIX with the reversal of the CHMP opinion, you sort of set this 15% threshold for contribution. Just thinking about the peak opportunity, I guess, is that a reasonable sort of benchmark, or do you have any analogs that you can point to in the rare disease space that can sort of set expectations to what contribution ex US that DAYBUE could potentially have to your franchise?

嗨，近況如何？非常感謝你們回答我們的問題。我是 Julian，代 Paul 提問。談到 DAYBUE STIX 以及 CHMP 意見被推翻後的情況，你們設定了境外貢獻 15% 的門檻。我想就峰值機會來看，這是否是一個合理的基準？或者在罕見疾病領域，你們是否有任何可類比的案例，能用來設定 DAYBUE 在美國以外市場可能對你們產品組合帶來的貢獻預期？

And then one quick question also on remlifanserin. There have been some studies published out there from independent authors that suggest that pimavanserin unapproved doses can get to 90% receptor occupancy after only a couple of weeks of dosing.

另外再快速問一個關於 remlifanserin 的問題。有一些獨立作者發表的研究指出，pimavanserin 在未核准的劑量下，僅用藥幾週後受體佔有率可達 90%。

I guess just with the improvements to your molecule, what do you think is -- is it fair to expect that it’s going to be driving greater efficacy due to receptor occupancy, or is it going to be elucidating an effect due to the improvements you made to the clinical trial? Thank you.

我想問的是，基於你們分子所做的改良，你們認為——是否可以合理預期它會因受體佔有率而帶來更高療效？還是說，它將主要是因你們對臨床試驗所做的改良而闡明（呈現）效果？謝謝。

Thanks, Julian. I’ll just make a quick comment around the peak opportunity for DAYBUE outside the US. As we’ve talked about already, we’ve guided to $700 million in 2028. That is definitely not the peak opportunity that we see. That is the 2028 number, just to be clear about that. Right now we’re talking about around 15% of those sales to be from outside the US.

謝謝你，Julian。我先就 DAYBUE 在美國以外市場的峰值機會做個簡短說明。如我們先前已談到的，我們指引 2028 年為 7 億美元。那絕對不是我們所看到的峰值機會。為了釐清，那是 2028 年的數字。目前我們談的是其中約 15% 的銷售額將來自美國以外市場。

That is obviously highly dependent on the reimbursement decisions that we get as we move through the reimbursement discussions that we’ve already sort of talked about. I would say that’s an average analog for other rare disease opportunities.

這顯然高度取決於我們在推進報銷（給付）討論過程中所獲得的報銷決策，而這些討論我們先前也已大致提過。我會說，這是其他罕見疾病機會的一個平均類比值。

As we progress through the reimbursement discussions and we get those decisions and we get the first view of prices in the EU, we will be better able to articulate what percentage of our 2028 sales as well as further future peak opportunities would be. But I think for right now, that’s a fairly normal analog for rare disease.

隨著我們推進報銷討論、取得相關決策，並在歐盟首次看到定價水準後，我們將能更清楚地說明 2028 年銷售額中有多少比例，以及更長期未來峰值機會可能是多少。但就目前而言，這對罕見疾病來說算是相當常見的類比。

But as rare disease is very heterogeneous, there is really not a normal analog. It’s one that we are sticking with for right now, and we will update you as we go through. And I’m now going to hand the other question back to Liz.

不過，由於罕見疾病的異質性非常高，實際上並不存在真正「正常」的類比。這是我們目前暫時採用的假設，我們也會在推進過程中向各位更新。接下來我把另一個問題交回給 Liz。

Yeah. Briefly, I suspect that the data that you’re referring to is in young, healthy volunteers, because that’s where most of the receptor occupancy information is. And I’ll say that is true that we get to near full receptor occupancy, even with pimavanserin at marketed doses. It is our expectation and belief that in elderly and diseased patients, this is a bit of a different animal, and higher levels are going to be necessary to get to the same receptor occupancy.

好的。簡單說，我猜您所指的數據是在年輕、健康志願者身上，因為大多數受體佔有率資訊都來自那裡。我也要說，確實如此：即使是 pimavanserin 以市售劑量，也能達到接近完全的受體佔有率。我們的預期與看法是，在高齡與患病患者身上，情況會有所不同，為了達到相同的受體佔有率，可能需要更高的暴露水準。

And to sort of support this, I would point again to the exposure response analyses that we’ve done out of prior datasets in both Alzheimer’s and Lewy Body that do suggest that levels that are higher than what you can get to with a marketed dose of pimavanserin on average do seem to be associated with higher efficacy.

為了支持這一點，我會再次提到我們基於先前資料集所做的暴露—反應分析，涵蓋阿茲海默症與路易氏體（Lewy Body）兩個族群；分析確實顯示，平均而言，高於 pimavanserin 市售劑量所能達到的水準，似乎與更高療效相關。

So again, I think that that is a strong reason to believe there’s the potential for greater efficacy. But I will say that even if the degree of efficacy we saw with remlifanserin winds up being more similar to what we’ve seen with pimavanserin, we’re structuring our programs in such a way by being focused on the individual diseases and properly powered, such that I think that we have an increased likelihood of technical and regulatory success, even if the effect were to be similar to the pimavanserin in terms of its scope.

因此，我認為這是相信存在更高療效潛力的一個強力理由。但我也要說，即便 remlifanserin 最終呈現的療效程度更接近我們在 pimavanserin 上看到的結果，我們仍以聚焦於各個疾病、並適當設計統計效力（properly powered）的方式來規劃我們的計畫；因此我認為，即使效果範圍與 pimavanserin 類似，我們在技術與法規層面的成功機率也會提高。

Thanks, Liz.

謝謝你，Liz。

Ladies and gentlemen, that concludes our question and answer session. I will now turn the conference back over to Catherine Owen Adams for closing remarks.

各位女士、先生，我們的問答環節到此結束。接下來我將把會議交回給 Catherine Owen Adams 作結語。

We’d just like to thank you all for your questions and continued support of ACADIA and look forward to reporting on our next quarter, where we will have an exciting set of results for remlifanserin. Thank you all for your attention today.

我們想感謝各位的提問，以及持續對 ACADIA 的支持；也期待在下一季的報告中向各位揭露 remlifanserin 一系列令人振奮的結果。感謝各位今天的關注。

This concludes today’s call. We thank you for your participation. You may now disconnect.

今天的電話會議到此結束。感謝各位的參與。您現在可以掛線。