Neurocrine Biosciences Inc (NBIX) 2025 Q3 法說會逐字稿

Good day, everyone, and welcome to today's Neurocrine Biosciences third-quarter 2025 results call. (Operator Instructions) Please note, this call is being recorded. I will be standing by if you should need any assistance.

大家好，歡迎參加今天的Neurocrine Biosciences 2025年第三季業績電話會議。（操作員指示）請注意，本次通話正在錄音。如果您需要任何幫助，我隨時待命。

It is now my pleasure to turn the conference over to Vice President of Investor Relations, Todd Tushla.

現在我很高興將會議交給投資者關係副總裁托德·圖什拉。

Hi, everybody, and a very pleasant good afternoon to you wherever you may be. Welcome to Neurocrine Biosciences third-quarter 2025 earnings call. I'm joined today by Kyle Gano, Chief Executive Officer; Matt Abernethy, Chief Financial Officer; Eric Benevich, Chief Commercial Officer; and Sanjay Keswani, Chief Medical Officer.

大家好，無論你們身在何處，都祝你們下午愉快。歡迎參加Neurocrine Biosciences 2025年第三季財報電話會議。今天與我一同出席的有：執行長 Kyle Gano；財務長 Matt Abernethy；首席商務官 Eric Benevich；以及首席醫療官 Sanjay Keswani。

During our call, we will be making forward-looking statements. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to review the risk factors discussed in our latest SEC filings. After prepared remarks and as is our standard practice, we will try to address all your questions.

在本次電話會議中，我們將發表一些前瞻性聲明。這些聲明存在一定的風險和不確定性，我們的實際結果可能與此有重大差異。我建議您仔細閱讀我們最新提交給美國證券交易委員會的文件中討論的風險因素。在發表完準備好的演講後，我們將按照慣例回答各位提出的所有問題。

With that, I turn the call over to Kyle.

於是，我把電話轉給了凱爾。

Thank you, Todd. Good afternoon, everyone. Our third quarter results reflect Neurocrine's exceptional execution and the strength of our enterprise-wide momentum as we continue to deliver across our commercial, clinical and operational objectives.

謝謝你，托德。大家下午好。第三季業績反映了Neurocrine卓越的執行力和公司整體強勁的發展勢頭，我們繼續在商業、臨床和營運目標方面取得進展。

From a commercial perspective, for INGREZZA, the recent investments to expand our sales force and improve patient access drove yet another record quarter for both new patient starts and total prescriptions. Highlighting the persistent unmet need for patients with tardive dyskinesia and Huntington's chorea.

從商業角度來看，對於 INGREZZA 而言，最近在擴大銷售隊伍和改善患者就醫途徑方面的投資，推動了新患者開戶量和處方總量再次創下季度新紀錄。強調遲發性運動障礙和亨丁頓舞蹈症患者持續存在的未滿足需求。

With CRENESSITY, the strong launch highlights its role as a first-in-class therapy, redefining the standard of care for patients with classical congenital adrenal hyperplasia or CAH. While there is still much to learn, we are encouraged by the early response from the CAH community and the potential to make a lasting impact for patients.

CRENESSITY 的強勢上市凸顯了其作為同類首創療法的地位，重新定義了經典先天性腎上腺皮質增生症 (CAH) 患者的治療標準。雖然還有很多東西需要學習，但我們對 CAH 社群的早期反應以及為患者帶來持久影響的潛力感到鼓舞。

Momentum for both INGREZZA and CRENESSITY is strong and we believe continued targeted investments in these commercial assets will accelerate growth into 2026 and beyond. In our clinical portfolio, I am pleased with the study enrollment progress in our Phase III studies of osavampator in major depressive disorder in direclidinein schizophrenia.

INGREZZA 和 CRENESSITY 的發展勢頭強勁，我們相信，對這些商業資產的持續有針對性的投資將加速其在 2026 年及以後的成長。在我們的臨床產品組合中，我對奧沙伐他汀治療重度憂鬱症和精神分裂症的 III 期研究的入組進展感到滿意。

We remain on track to meet enrollment objectives for the year. Beyond these late-stage programs, we continue to advance a robust early and mid-stage as expanding through high-quality preclinical programs emerging from Neurocrine's internal discovery efforts. To this end, I'm also happy to report that we are on track to achieve our R&D productivity goals for the year, specifically four new Phase I study initiations and two new Phase II initiations.

我們仍有望實現今年的招生目標。除了這些後期項目之外，我們還透過Neurocrine內部研發工作中湧現的高品質臨床前項目，繼續推動穩健的早期和中期項目。為此，我也很高興地報告說，我們正按計劃實現今年的研發生產力目標，具體而言，啟動了四項新的 I 期研究和兩項新的 II 期研究。

Advancing two potentially standard of care changing medicines until the final phase of development, while simultaneously driving early and mid-stage innovation represents a record level of productivity for us and positions Neurocrine exceptionally well for the future. As I reflect on my more than 20 years at Neurocrine and just over one year as CEO, I'm deeply proud of how far we've come.

推進兩種可能改變治療標準的藥物研發至最後階段，同時推動早期和中期創新，這代表了我們創紀錄的生產力水平，也使 Neurocrine 在未來擁有了非常有利的地位。回顧我在Neurocrine的20多年以及擔任CEO的一年多時間，我為我們所取得的成就深感自豪。

Yet as we continue to evolve, I'm even more inspired of what lies ahead. Neurocrine is poised into a new chapter of sustained long-term growth, driven by our science, our people and our unwavering commitment to the patients we serve and investors to support our mission.

然而，隨著我們不斷發展，我對未來更加充滿期待。在我們的科學、我們的員工以及我們對所服務的患者和支持我們使命的投資者的堅定承諾的推動下，Neurocrine 已準備好進入持續長期增長的新篇章。

With that, I'll turn the call over to Matt.

接下來，我將把電話交給馬特。

Thank you, Kyle, and good afternoon, everyone. The third quarter was strong across the board for Neurocrine, with $790 million in net product sales, reflecting 28% year-over-year growth. Driven by continued progress both from CRENESSITY and INGREZZA, congrats to all involved in the performance of these two medicines. CRENESSITY grew sequentially from $53 million in Q2 to $98 million in Q3, reflecting strong early adoption and persistency rates.

謝謝你，凱爾，大家下午好。Neurocrine 第三季整體表現強勁，淨產品銷售額達 7.9 億美元，較去年同期成長 28%。CRENESSITY 和 INGREZZA 都取得了持續進展，祝賀所有參與這兩種藥物研發的人員。CRENESSITY 的營收從第二季的 5,300 萬美元環比成長到第三季的 9,800 萬美元，反映出早期用戶採用率和用戶留存率的強勁成長。

In addition, 80% of dispensed prescriptions are now being reimbursed. Feedback from patients and KOLs remains quite favorable in terms of CRENESSITY's efficacy, safety and tolerability profile. We look forward to continuing to add patients to therapy and to further establishing CRENESSITY as a standard of care treatment for patients with CAH.

此外，目前80%的處方藥都能獲得報銷。患者和 KOL 對 CRENESSITY 的療效、安全性和耐受性方面的回饋仍然相當積極。我們期待繼續增加接受治療的患者，並進一步確立 CRENESSITY 作為 CAH 患者的標準治療方案。

Momentum for INGREZZA also continues to build with our third consecutive quarter of record new patient additions in Q3, resulting in net sales of $687 million. Of note, as you consider modeling Q4, the third quarter benefited from a 14th ordering week. Outside of this ordering dynamic, the combination of improved access and our sales force expansion, are resulting in double-digit TRx growth, record NRx and market share gains through the first nine months of the year.

INGREZZA 的發展動能也持續增強，第三季新增病患數量連續第三個季度創下紀錄，淨銷售額達到 6.87 億美元。值得注意的是，在考慮對第四季度進行建模時，第三季度受益於第 14 週的訂單量。除了上述訂單動態之外，通路改善和銷售隊伍擴張相結合，使得今年前九個月的處方量（TRx）實現了兩位數增長，新處方量（NRx）和市場份額均創歷史新高。

On the heels of this momentum and strength of the TD market, we have decided to pursue an additional sales force expansion with three goals in mind. First, accelerate the development of the TD market between now and 2029, strengthening our position as we navigate the potential impacts of the Inflation Reduction Act.

鑑於 TD 市場的這種發展勢頭和強勁勢頭，我們決定進一步擴大銷售隊伍，並設定了三個目標。首先，加速從現在到 2029 年期間 TD 市場的發展，以鞏固我們在應對《通貨膨脹削減法案》潛在影響方面的地位。

Second is to maximize INGREZZA patient share during this window of time. And third, set the foundation of an expanded psychiatry portfolio, anticipating one or more of our late-stage clinical programs will have successful top line data in 2027. From a financial perspective, the expanded investment in both INGREZZA and CRENESSITY will result in an SG&A expense increase of around $150 million in 2026. We will, of course, provide a fuller financial picture for Neurocrine in February next year, but I wanted to give you this insight for now.

其次，要在此期間最大限度地提高 INGREZZA 患者份額。第三，為擴大精神病學產品組合奠定基礎，預計我們的一個或多個後期臨床計畫將在 2027 年獲得成功的初步數據。從財務角度來看，對 INGREZZA 和 CRENESSITY 的擴大投資將導致 2026 年銷售、一般及行政費用增加約 1.5 億美元。當然，我們將在明年二月提供Neurocrine更全面的財務狀況，但我現在想先向你們提供這些資訊。

To close, our capital allocation priority is to remain intact. Number one, drive revenue growth; number two, advance our R&D programs; number three, enable business development; and number four, return capital to shareholders. Our top line growth and financial profile of over $2.1 billion in cash is the foundation for continued investment in our internal pipeline, which will position Neurocrine for sustained growth and enable us to deliver new innovative therapies to patients with unmet needs in the years ahead.

最後，我們的資本配置優先事項是保持不變。第一，推動收入成長；第二，推動研發項目；第三，促進業務發展；第四，向股東返還資本。我們營收成長強勁，現金儲備超過 21 億美元，這為我們持續投資內部研發管線奠定了基礎，這將使 Neurocrine 能夠持續成長，並使我們能夠在未來幾年為有未滿足需求的患者提供新的創新療法。

With that, I will now hand the call over to Eric Benevich, our Chief Commercial Officer. Eric?

接下來，我將把電話交給我們的商務長艾瑞克·貝內維奇。艾瑞克？

Thanks, Matt. Q3 was another banner quarter for our brands. Our commercial and medical teams continued to deliver with a record quarter for both INGREZZA and CRENESSITY with combined net sales of $785 million. Starting with INGREZZA, performance through the first nine months of 2025 has been exceptional, reflecting both the strong clinical profile and the continued significant unmet need for people living with tardive dyskinesia or Huntington's chorea.

謝謝你，馬特。第三季是我們旗下品牌又一個業績斐然的季度。我們的商業和醫療團隊繼續取得佳績，INGREZZA 和 CRENESSITY 兩款產品均創下季度銷售紀錄，合計淨銷售額達 7.85 億美元。從 INGREZZA 開始，2025 年前九個月的表現非常出色，這不僅反映了其強大的臨床表現，也反映了遲發性運動障礙或亨廷頓舞蹈症患者持續存在的重大未滿足需求。

Past strategic investments to expand the sales force and improve access have been positive, yielding a third consecutive quarter of record new patient starts and total prescriptions. Today, of a population exceeding 800,000, we estimate only about half of those living with TD have received a diagnosis for their uncontrolled movements, and only about 10% are currently being treated with the VMAT2 Inhibitor. With exclusivity out to 2038, there remains a significant organic growth opportunity ahead.

過去在擴大銷售團隊和改善服務管道方面進行的策略性投資取得了積極成效，連續第三個季度創下新患者開戶量和處方總量的新紀錄。如今，在超過 80 萬人口中，我們估計只有大約一半患有 TD 的人得到了對其不受控制的運動的診斷，而目前只有大約 10% 的人正在接受 VMAT2 抑制劑治療。由於獨家經銷權將持續到 2038 年，未來仍存在巨大的自然成長機會。

Our INGREZZA prescriber base continues to expand, particularly in psychiatry, where advanced practice providers, such as nurse practitioners and physician associates now account for the majority of psychiatric patient care in the United States. As an example, our INGREZZA prescriber base is 30% larger today than it was two years ago at this time.

我們的 INGREZZA 處方醫師群體持續擴大，尤其是在精神科領域，高級執業人員（如執業護理師和醫師助理）目前在美國精神病患照護方面佔大多數。例如，我們目前的 INGREZZA 處方醫生數量比兩年前同期增加了 30%。

In addition, TD prevalence continues to increase in conjunction with broader use of antipsychotic medications. In light of our strong momentum and the significant growth opportunity, we've made the decision to further scale up our INGREZZA sales force to meet this growing demand.

此外，隨著抗精神病藥物的廣泛使用，TD 的盛行率也持續上升。鑑於我們強勁的發展勢頭和巨大的成長機會，我們決定進一步擴大 INGREZZA 銷售團隊，以滿足不斷增長的需求。

Going forward, we will be expanding and restructuring our INGREZZA sales organization to create two dedicated teams, one combined neuropsych team and our existing Long-Term Care team. Both the Neuropsych and LTC teams will be expanded to enable us to engage more VMAT2 prescribers than ever before and deepen relationships across our current base of prescribers.

展望未來，我們將擴大和重組 INGREZZA 銷售組織，創建兩個專門的團隊，一個是神經心理學團隊，另一個是我們現有的長期照護團隊。我們將擴大神經心理學團隊和長期照護團隊，以便比以往任何時候都吸引更多的 VMAT2 處方醫生，並加深與我們現有處方醫生群體的關係。

Consistent with prior expansions, success will be measured by growth in new patient starts and total prescriptions, metrics, which typically show the full impact of field expansion several quarters after deployment. The expansion of the sales teams set INGREZZA up well for 2026 and beyond. Will also help position us for the anticipated launches of our next wave of investigational psychiatric medicines currently in Phase III development.

與以往的擴張計劃一致，成功與否將透過新患者數量和處方總量的增長來衡量，這些指標通常會在部署後的幾個季度內顯示領域擴張的全面影響。銷售團隊的擴張為 INGREZZA 在 2026 年及以後的發展奠定了良好的基礎。也將有助於我們為即將推出的下一批處於 III 期研發階段的在研精神藥物做好準備。

Now turning to CRENESSITY. Our launch mantra of So Far, So Great, remains well deserved with Q3 net sales reaching $98 million in just the third full quarter on the market. During the third quarter, 540 new patients initiated therapy, bringing the total number of classic CAH patients on therapy since launch to more than 1,600. As we've said from the outset, this is a new market we are building, and therefore, this is a learning launch.

現在轉向 CRENESSITY。我們「目前為止，一切都很棒」的開局口號依然名副其實，第三季淨銷售額在上市僅第三個完整季度就達到了 9800 萬美元。第三季度，540 名新患者開始接受治療，使自上市以來接受治療的經典 CAH 患者總數超過 1600 人。正如我們從一開始就說過的那樣，我們正在打造一個全新的市場，因此，這是一個學習型的發布。

With CRENESSITY representing the first therapy developed and approved specifically for patients with classic CAH we continue to gain important insights into prescriber behavior, patient dynamics and potential seasonality trends. We continue to see steady adoption. And while the pace of new patient starts may vary from quarter-to-quarter, the strong persistence and adherence rates observed to date give us confidence in continued volume growth going forward.

CRENESSITY 是第一個專門為經典 CAH 患者開發和批准的療法，我們將繼續深入了解處方醫生的行為、患者的動態以及潛在的季節性趨勢。我們看到用戶數量持續穩定成長。雖然每季新患者的成長速度可能有所不同，但迄今為止觀察到的強勁的持續性和依從率讓我們有信心在未來繼續實現業務量成長。

In the third quarter, patient demand modestly favored the pediatric population versus adults, and skewed towards female patients. Prescriptions continue to be written by a range of endocrinology providers, including those practicing in multidisciplinary centers of excellence, pediatric endocrinologists and community-based adult endocrinologists.

第三季度，患者需求略偏向兒科患者而非成人，且女性患者略多。處方仍由各種內分泌科醫生開具，包括在多學科卓越中心執業的醫生、兒科內分泌科醫生和社區成人內分泌科醫生。

On the payer front, we continue to see strong reimbursement. Launch to date, nine out of 10 people taking CRENESSITY have received approval for their insurance, and CRENESSITY is affordable with nine out of 10 people paying $10 or less per month out of pocket, most pay 0. So far, insurance reimbursement has not been a barrier to treatment.

在支付方方面，我們持續看到強勁的報銷力道。截至目前，服用 CRENESSITY 的 10 人中有 9 人已獲得保險批准，而且 CRENESSITY 價格實惠，10 人中有 9 人每月自付 10 美元或更少，大多數人無需支付任何費用。到目前為止，保險報銷尚未成為治療的障礙。

As the first and only FDA-approved treatment specifically for classic CAH, CRENESSITY delivers a compelling combination of efficacy, safety and tolerability. Our ongoing open-label extension studies continue to generate valuable data on quality of life, long-term safety and differentiating outcomes, which will further strengthen an already robust data set.

作為第一個也是唯一一個獲得 FDA 批准專門用於治療經典 CAH 的藥物，CRENESSITY 具有令人信服的療效、安全性和耐受性組合。我們正在進行的開放標籤擴展研究不斷產生有關生活品質、長期安全性和差異化結果的寶貴數據，這將進一步加強現有的強大數據集。

We estimate approximately 20,000 people in the US live with classic CAH. Based on the very favorable receptivity from the CAH community and the opportunity to bring relief to more people with CAH we've made the decision to also expand our CRENESSITY sales team.

我們估計美國約有 2 萬人患有經典型先天性腎上腺皮質增生症 (CAH)。鑑於 CAH 社群的正面反響，以及為更多 CAH 患者帶來緩解的機會，我們決定擴大 CRENESSITY 銷售團隊。

As I said in my opening comments, we're executing very well from a commercial perspective. Both our products are fast-growing, innovative first-in- disease medicines. Given the significant growth potential for each, it was a straightforward decision to expand both the INGREZZA and CRENESSITY sales teams. This is an investment in growth and an investment in our future.

正如我在開場白中所說，從商業角度來看，我們的執行情況非常好。我們的兩款產品都是快速成長、創新的首創疾病治療藥物。鑑於 INGREZZA 和 CRENESSITY 各自都具有巨大的成長潛力，因此擴大這兩個品牌的銷售團隊是一個直接的決定。這是對成長的投資，也是對我們未來的投資。

Both sales team expansions will be fully completed by the end of Q1, and we can give further color on our progress as we get into 2026. These are very exciting times here at Neurocrine as we make good on our promise to deliver brave science.

兩項銷售團隊擴充計畫將於第一季末全面完成，到 2026 年，我們將進一步詳細說明我們的進展。對Neurocrine來說，這是一個令人興奮的時刻，因為我們正在兌現承諾，帶來勇敢的科學成果。

So with that, I'll hand the call over to Dr. Sanjay Keswani, our Chief Medical Officer.

那麼，接下來我將把電話交給我們的首席醫療官桑傑·凱斯瓦尼博士。

Thanks, Eric, and good afternoon to everyone. My prepared remarks for today will be brief as we remain on track for all our clinical programs. We anticipate top line results in the fourth quarter for valbenazine in Dyskinetic Cerebral Palsy as well as for the Phase II proof-of-concept and dose finding study of NBI-'770, that's our NR2B NAM as an adjunctive treatment in major depressor disorder.

謝謝你，埃里克，大家下午好。今天我的發言將比較簡短，因為我們所有的臨床項目都將繼續按計劃進行。我們預計在第四季度將公佈纈苯那嗪治療運動障礙性腦性麻痺的初步結果，以及 NBI-'770（我們的 NR2B NAM，用於治療重度憂鬱症的輔助治療）的 II 期概念驗證和劑量探索研究的初步結果。

As a reminder, positive results from NBI-'770 could support a confirmatory Phase II study or the initiation of a Phase III trial in MDD. As Kyle mentioned earlier, the Phase III studies for Osavampator in major depressive disorder and [direclidineine] or NBI-'568 in schizophrenia continue to enroll well, alongside solid progress for the rest of our early to mid-stage pipeline.

提醒大家，NBI-'770 的正面結果可能支持進行 II 期驗證性研究或啟動 MDD 的 III 期試驗。正如 Kyle 之前提到的，Osavampator 用於治療重度憂鬱症的 III 期研究以及 [direclidinene] 或 NBI-'568 用於治療精神分裂症的 III 期研究仍在順利招募患者，同時我們早期到中期研發管線的其他部分也取得了穩步進展。

You've heard us talk about our upcoming R&D day throughout today's call. As my colleagues alluded to, we are excited to welcome the Wall Street community to our San Diego campus where we'll have an opportunity to provide greater detail into our long-term vision, much of which stems from enthusiasm around our clinical and early-stage programs, plans and recent progress. To provide a bit more detail on the agenda, I will provide an overview of our neuropsychiatry programs with a spotlight on Osavampator and our broad Muscarinic Agonist portfolio.

在今天的電話會議中，你們已經聽到我們談到即將舉行的研發日活動。正如我的同事所提到的，我們很高興歡迎華爾街社區來到我們在聖地牙哥的園區，在那裡我們將有機會更詳細地介紹我們的長期願景，這很大程度上源於我們對臨床和早期計畫、計劃和近期進展的熱情。為了更詳細地介紹議程，我將概述我們的神經精神病學項目，重點介紹 Osavampator 和我們廣泛的毒蕈鹼激動劑產品組合。

Following my presentation, Dr. John Krystal, a leading psychiatrists from Yale University will join me for a moderated Q&A session. Afterwards, Jude Onyia, our Chief Scientific Officer, will discuss Neurocrine's ongoing R&D transformation efforts and preview a few of the next-generation programs expected to enter clinical development.

演講結束後，耶魯大學的著名精神科醫生約翰·克里斯特爾博士將與我一起參加由主持人引導的問答環節。隨後，我們的首席科學長 Jude Onyia 將討論 Neurocrine 正在進行的研發轉型工作，並預覽一些預計將進入臨床開發的下一代專案。

We look forward to seeing many of you there as we unveil the foundation for Neurocrine's next chapter. With that, I will hand the call back to Kyle.

我們期待在揭開 Neurocrine 下一個篇章的基石之際，與大家見面。這樣，我就把電話交還給凱爾了。

Thanks, Sanjay. I think we're ready to take questions now.

謝謝你，桑傑。我認為我們現在可以開始回答問題了。

(Operator Instructions)

（操作說明）

Phil Nadeau, TD Cowen.

菲爾·納多，TD·考恩。

Good afternoon. Congratulations on a really strong quarter and great commercial performance. I wanted to just ask about the patient dynamics and patient starts for CRENESSITY. It did seem like enrollment forms were a little bit lower in Q3 than Q2. Was this seasonality or a sign of maybe an early launch bonus? Any insights you can give us on those trends would be helpful as we look to model the next several quarters of CRENESSITY?

午安.恭喜公司本季業績強勁，商業表現優異。我只是想了解一下 CRENESSITY 的患者動態和患者起始情況。第三季的報名表數量似乎比第二季略少。這是季節性現象，還是可能是早期發布獎勵的跡象？如果您能就這些趨勢提供任何見解，將有助於我們預測 CRENESSITY 未來幾季的發展趨勢？

Hi Phil, this is Eric. So Obviously, we're really pretty pleased with the overall adoption of CRENESSITY launch to date and with 540 new treatment forms in Q3. And we saw that as a continuation to the strong adoption that we saw earlier in the year in the first half. We said at the beginning, we expected this to be a steady or measured launch. And so far, it really has borne out that way. The weekly adoption has been really consistent over the course of the summer.

你好菲爾，我是艾瑞克。顯然，我們對 CRENESSITY 迄今為止的整體推廣情況以及第三季新增的 540 種治療方案感到非常滿意。我們認為這是今年上半年強勁成長動能的延續。我們一開始就說過，我們預計這將是一次穩步或有條不紊的發布。到目前為止，情況確實如此。整個夏季，每週的收養數量都非常穩定。

We don't think that there's necessarily any kind of quarterly dynamics going on or seasonality. We are still early in the launch, and we'll have to see how things bear out after we've gone through a few cycles. But ultimately, we're really pleased with the enrollment. And with over 1,600 treatment forms through Q3, we're really optimistic and expect to see this accumulation of patients as we go forward.

我們認為這其中並不一定存在任何季度性的動態變化或季節性因素。我們目前還處於產品發布初期，還需要經過幾個週期的測試才能知道結果如何。但總的來說，我們對招生情況非常滿意。截至第三季度，我們已收到超過 1600 份治療申請，我們對此非常樂觀，並預計隨著疫情發展，患者數量將繼續增加。

Phil, thanks for setting the tone also and asking just one question. So just hygiene purposes, we'll stick to the answering the first question that gets asked.

菲爾，謝謝你定調，也謝謝你只提了一個問題。出於衛生考慮，我們將只回答被問到的第一個問題。

Paul Matteis, Stifel.

Paul Matteis，Stifel。

Hey, thanks so much, and let me add my congrats on the quarter. I wanted to ask a question, I guess, about the IRA and I hope you bear with me as it has two subparts for this where I got is really only one question. Just can you help us set up how you guys are thinking about the upcoming AUSTEDO price that we'll learn about? And just what are the sort of implications for Neurocrine?

嘿，非常感謝，也請容許我祝賀你們本季取得佳績。我想問一個關於愛爾蘭共和軍（IRA）的問題，希望您能耐心聽我說，因為這個問題有兩個子部分，但我實際上只有一個問題。能否請您幫我們說明一下，你們是如何考慮即將公佈的AUSTEDO價格的？我們很快就會了解這個價格。那麼，這對神經分泌系統究竟意味著什麼呢？

And then for INGREZZA, given the increased discounting and now that we're looking at a gross net that's getting up into the mid- to high 30s. Should we think that the worst-case scenario for you has now changed given that the small biotech exemption has the discounting to a level that is actually potentially going to be below where your gross to net ends up?

至於 INGREZZA，考慮到折扣力度加大，現在毛淨值已經達到 30 多萬。鑑於小型生物技術豁免政策的折扣幅度可能低於您的毛利潤到淨利潤的最終結果，我們是否應該認為您面臨的最壞情況已經發生了變化？

Thanks, Paul. A lot to unpack there. Maybe I'll start with the first question and see how far we get on that. I think when it comes to AUSTEDO, our view of this is that we'll learn its pricing across both the current immediate release and XR formulations in November. You should hear from CMS late November, if not sooner than that, but that's what we're planning on currently.

謝謝你，保羅。這裡面有很多資訊需要分析。或許我可以先從第一個問題開始，看看我們能討論到什麼程度。我認為，就 AUSTEDO 而言，我們的看法是，我們將在 11 月了解其當前速釋製劑和 XR 製劑的定價。您應該會在 11 月下旬收到 CMS 的通知，甚至可能更早，但這是我們目前的計劃。

In terms of our expectations, how it might affect INGREZZA. I think where we stand right now is we're trying to understand what the plans might do in reaction to AUSTEDO's pricing. Our view at this point is both the health plans and the PBMs will use a variety of strategies for medicines that go through the IRA as well as those medicines that are not going through an IRA type of moment.

就我們的預期而言，這可能會對 INGREZZA 產生怎樣的影響。我認為我們目前的情況是，我們正在試圖了解這些計劃可能會對 AUSTEDO 的定價做出怎樣的反應。我們目前的觀點是，無論是健康計劃還是藥品福利管理機構，都會對通過 IRA 的藥品以及那些不經歷 IRA 階段的藥品採取各種策略。

And for us, there are things that we know and don't know. And ultimately, where we stand right now is that INGREZZA is an incredibly sticky medicine. Once patients start INGREZZA, they tend to stay on it, which really means we're looking at -- looking at new patient starts during a two-year period of '27 to '29 when we reach our own IRA year.

對我們來說，有些事情我們知道，有些事情我們不知道。最終，我們目前的結論是，INGREZZA 是一種非常難治的藥物。一旦患者開始服用 INGREZZA，他們往往會堅持服用，這意味著我們實際上正在關注——關注 2027 年至 2029 年兩年期間的新患者開始服用情況，因為我們將進入我們自己的 IRA 年度。

So we'll look to contract here over the next, say, 12 to 14 months. As we approach 2027, we'll look to maximize the number of patients that are INGREZZA between now and the end of '26. And that will help us negate any headwinds on NRx's which to date, it's only about 5% of our total TRx.

因此，我們將在未來 12 到 14 個月內尋求縮小這一差距。隨著 2027 年的臨近，我們將努力在 2026 年底前最大限度地增加接受 INGREZZA 治療的患者人數。這將有助於我們抵消 NRx 的任何不利因素，到目前為止，NRx 僅占我們總 TRx 的 5% 左右。

So on a quarterly basis, that number is quite small. We'll look also to see if there's any learnings from those medicines that are negotiated and become implemented next year. And then I think most importantly here, we'll control what we can across INGREZZA, but across the portfolio, we'll look to build the company as strong as we can.

因此，按季度計算，這個數字相當小。我們也將關註明年談判和實施的那些藥物能否為我們帶來任何經驗教訓。然後我認為最重要的是，我們將控制 INGREZZA 內部我們能夠控制的一切，但就整個投資組合而言，我們將努力將公司打造得盡可能強大。

Paul, this is Eric. I just want to chime in and kind of reinforce a couple of points. One is that we do believe that there's room on formularies for MFP adjacent products. We think that PBMs and health plans will behave differently. There's not going to be sort of a uniform approach that they take.

保羅，這位是埃里克。我只想補充幾點，強調一下。一是我們確實相信，藥品目錄裡應該有 MFP 相關產品的空間。我們認為藥品福利管理機構和健康保險計劃的行為方式會有所不同。他們不會採取統一的做法。

And kind of tying in with our prepared remarks, it's really important that we maximize patient share going into '27 and beyond. And currently, that's what we're doing and that's part of the rationale for the sales force expansion for INGREZZA.

與我們事先準備好的發言內容相呼應，在 2027 年及以後，最大限度地提高患者份額至關重要。目前，我們正在這樣做，這也是 INGREZZA 擴大銷售隊伍的部分原因。

Tazeen Ahmad, Bank of America.

塔津·艾哈邁德，美國銀行。

Hi guys, good afternoon. Thanks for taking my question. Mine is going to be on CRENESSITY. So is it too early to know this, but are payers already looking for a certain level of steroid tapering in order to continue covering therapy? And just in terms of number of days in 3Q versus 4Q, we're heading into holiday season. So how should we be thinking about the potential for seasonal impact for CRENESSITY sales in 4Q?

大家好，下午好。謝謝您回答我的問題。我的帳號將會發佈在 CRENESSITY 上。現在判斷這個問題是否為時過早？但支付者是否已經開始關注類固醇藥物的減量程度，以便繼續支付治療費用？僅從第三季和第四季的天數來看，我們即將進入假期季節。那麼，我們應該如何看待 CRENESSITY 第四季銷售額可能受到的季節性影響呢？

Thanks for the question, Tazeen. This is Matt. We're not really anticipating seasonality outside of just the pace and cadence of patient visits into the clinician's office. So nothing on the seasonality front.

謝謝你的提問，塔津。這是馬特。除了患者到診所就診的頻率和節奏之外，我們並沒有真正預期會出現季節性變化。所以，季節性因素方面沒有任何影響。

In terms of reimbursement, really has not been a requirement for patients to titrate down steroids to a specific extent. It's really looking at do they have the underlying disease and do they have treatment with hydrocortisone? And if that's the case, reimbursement has been quite smooth. I just give a shout out to the team working on this, advocating on behalf of patients. And I'd say the insurance providers can understand the benefit of this new medicine for these patients.

就報銷而言，實際上並沒有要求患者將類固醇的用量減少到特定程度。關鍵在於看他們是否患有潛在疾病，以及他們是否接受過氫化可的松治療？如果情況屬實，那麼報銷過程相當順利。我只想對參與這項工作、為患者爭取權益的團隊表示讚揚。我認為保險公司能夠理解這種新藥對這些病人的好處。

Akash Tewari, Jefferies.

阿卡什‧特瓦里，傑富瑞集團。

This is Steve on for Akash. On INGREZZA, given that you mean sort of AUSTEDO (inaudible) already much more expensive than regular AUSTEDO. Is there any changes in payer preferences you've seen thus far? And then just in terms of the IRA negotiated pricing upcoming, how are you able to lock in INGREZZA's pricing through 2026 ahead of this announcement?

這裡是史蒂夫替阿卡什發言。關於 INGREZZA，鑑於你指的是某種 AUSTEDO（聽不清楚），它已經比普通的 AUSTEDO 貴得多。到目前為止，您是否觀察到支付方偏好有任何變化？那麼，就即將進行的 IRA 協商定價而言，您如何在公告發布前鎖定 INGREZZA 到 2026 年的定價？

Yes. No, thank you for the question. So I think the health plans are seeing that part of what Teva is doing is trying to push patients to higher dose strengths of both the BID and the XR formulation of Deutetrabenazine and since that product has a per-milligram pricing structure, higher doses mean more revenue per patient. Health plans are catching on to that. And we have seen examples of health plans that would, for example, cover the BID formulation, but not the XR.

是的。不，謝謝你的提問。所以我認為，醫療保險計劃已經意識到，梯瓦製藥正在努力推動患者使用更高劑量的氘代丁苯那嗪，無論是每日兩次還是緩釋製劑。由於該產品採用每毫克定價結構，更高的劑量意味著每位患者能獲得更高的收入。醫療保險公司也開始意識到這一點。我們已經看到一些健康計劃的例子，例如，這些計劃將涵蓋 BID 配方，但不會涵蓋 XR 配方。

So I think that the fact that we've seen this dose creep dynamic and/or patients transitioning to the XR formulation being more expensive to the plan that they've been more willing to engage with us. And I think it partly explains the ability that we've had this year midyear to expand our formulary coverage. The coverage that we have now, we expect to carry through 2026. And so in terms of expectation setting for next year, we should expect at least the same level of formulary coverage that we have now.

所以我認為，我們看到劑量逐漸增加的動態，以及/或患者過渡到緩釋製劑會增加治療計劃的成本，因此他們更願意與我們合作。我認為這在一定程度上解釋了為什麼我們今年年中能夠擴大藥品目錄的覆蓋範圍。我們目前的保險覆蓋範圍預計將持續到 2026 年。因此，就明年的預期而言，我們應該至少期待與現在相同的藥品目錄覆蓋水準。

But in most instances, we're seeing -- we're at parity from a formulary perspective. And that's always been our goal is to take an approach to give clinicians a choice as to what medicine they prefer. And that's going to be our strategy also going forward.

但在大多數情況下，我們看到——從配方角度來看，我們已經達到了平衡。我們的目標始終是採取一種方法，讓臨床醫生能夠選擇他們喜歡的藥物。這也將成為我們未來發展的策略。

Got it. Thank you so much.

知道了。太感謝了。

Mohit Bansal, Wells Fargo.

莫希特·班薩爾，富國銀行。

Great. Thank you very much for taking my question. And would love to touch upon the 10-Q filing and the talks about DOJ investigation. Any color you can provide on that? And how should we think about the next timeline from this one?

偉大的。非常感謝您回答我的問題。我很想談談 10-Q 文件以及有關司法部調查的討論。你能提供一下顏色資訊嗎？那麼，我們應該如何根據這條時間線來考慮下一個時間線呢？

Hi, Mohit. This is Kyle. I appreciate the question here on this. In August, we received a CID, a Civil Investigative Demand from the DOJ requesting certain documents and information attached to sales, marketing and promotion of INGREZZA. Of course, we're fully cooperating with the DOJ. And I think right now, there's not much more to say on that. We'd certainly keep the external community updated when there's material information to share on that.

你好，莫希特。這是凱爾。我很感謝大家提出這個問題。8 月，我們收到司法部發出的民事調查令 (CID)，要求提供與 INGREZZA 的銷售、行銷和推廣相關的某些文件和資訊。當然，我們正在全力配合司法部的調查。我覺得現在關於這個問題，沒什麼好說的了。當有實質資訊需要分享時，我們一定會及時向外界通報。

The only piece I would conclude with is that we have an extremely robust compliance program here at Neurocrine. We take compliance seriously and the responsibility that comes with that. And as we move forward here, we'll continue business as usual because we think that's the right thing to do. Again, we'll keep folks updated as we learn more.

最後我想補充一點，Neurocrine 有非常完善的合規計畫。我們非常重視合規性以及隨之而來的責任。接下來，我們將繼續照常開展業務，因為我們認為這是正確的做法。我們會隨時更新最新消息。

Cory Kasimov, Evercore.

Cory Kasimov，Evercore。

Hey, good afternoon, guys.

嘿，各位下午好。

Thanks for taking the question. Mine is on CRENESSITY. I guess I'm wondering if you can speak to where you are with getting CRENESSITY up and running at this point at the centers of excellence and then the progress that's also being made in the community setting where doc see fewer patients. Are you more or less at every COE at this point? And do you see that opportunity on the community level?

感謝您回答這個問題。我的帳號是CRENESSITY。我想問的是，您能否談談目前在卓越中心啟動和運行 CRENESSITY 的進展情況，以及在醫生接診患者較少的社區環境中取得的進展情況。目前你基本上每個卓越中心都去過嗎？您是否在社區層面看到了這種機會？

Yes. And just to recap, we estimate there's around 20 centers of excellence out there that care for roughly 15% of the classic CAH patient community. Yes. I mean, all the COEs have now started adopting though, I would say, a different pace. And I think that reflects the sort of the different ways that they work, the level of bureaucracy, the level of access, et cetera. But for the most part, our view is that the rate of adoption that we're seeing in the COEs is mostly a function of the rate at which patients are flowing through.

是的。最後總結一下，我們估計目前大約有 20 個卓越中心，為大約 15% 的經典 CAH 患者群體提供護理。是的。我的意思是，所有卓越中心現在都開始採用這些技術了，不過速度各不相同。我認為這反映了他們不同的工作方式、官僚程度、進入程度等等。但總的來說，我們認為，我們在卓越中心看到的採用率主要​​取決於患者就診的速度。

We've also been surprised -- very pleasantly surprised, I think, by the rate of adoption with community endocrinologists that treat the adults. Most of these practices, as you rightly call out, only have one or two patients. And so that's where you get into a much wider pool of HCPs to reach. And kind of tying back to our prepared comments as part of the rationale for expanding our field sales team to go a little bit deeper into our call universe and to be able to reach some of these practices that we haven't yet tapped into.

我們也感到非常驚訝——我認為是驚喜——社區內分泌學家對治療成年人的這種做法的接受度很高。正如您所指出的，這些診所大多只有一兩個病人。因此，這樣你就能接觸到更廣泛的醫療保健專業人員群體。這與我們之前準備好的評論有點關聯，這也是我們擴大現場銷售團隊的理由之一，目的是讓我們能夠更深入地了解我們的客戶群體，並能夠接觸到一些我們尚未涉足的領域。

Anupam Rama, JPMorgan.

Anupam Rama，摩根大通。

Hey guys, thanks so much for taking the question and congrats on the quarter. Could you provide a little bit more color and maybe some quantification around the sales force expansion for both products in terms of the segments that are going to be targeted here for INGREZZA. Is its psychiatry, neurology, long term or for CRENESSITY, general endos versus pediatric endos?

各位，非常感謝你們回答這個問題，也恭喜你們本季取得好成績。您能否就 INGREZZA 這兩款產品的銷售隊伍擴張情況，特別是針對特定細分市場的情況，提供更詳細的資訊和一些量化數據？是精神科、神經科、長期病學，還是針對 CRENESSITY 的普通內視鏡與兒科內視鏡？

Yes. So in terms of scale, I would characterize it as about a 30% increase in terms of our overall sales footprint across both products. Obviously, INGREZZA is a bigger product. So most of the incremental headcount are going to be going to INGREZZA. I said in my prepared remarks that we were going to be both restructuring and expanding.

是的。因此，就規模而言，我認為我們兩款產品的整體銷售規模將成長約 30%。顯然，INGREZZA 是一個更大的產品。因此，大部分新增員工將進入 INGREZZA 部門。我在事先準備好的演講稿中說過，我們將進行重組和擴張。

And what we're doing with INGREZZA is essentially combining our existing psychiatry and neurology teams, and then expanding the headcount there because what we've seen is that we could do a better job, I think, of covering our psychiatry and neurology customers who, in many ways, are more similar than they are different by having a cohesive team versus having multiple different teams with different reporting structures.

我們對 INGREZZA 所做的，本質上是將我們現有的精神病學和神經病學團隊合併，然後擴大人員規模，因為我們發現，如果我們擁有一個凝聚力強的團隊，而不是多個擁有不同匯報結構的團隊，那麼我們可以更好地服務於我們的精神病學和神經病學客戶，他們在很多方面都比不同之處更多。

So I think that this simplifies things substantially for us going forward. We're going to keep the LTC team separate and we are expanding that group as well. There's been a continuing fast-growing segment for us. So we're excited about increasing our coverage of high-potential psych providers and neurology providers with the Neuropsych team and then adding more headcount into LTC.

所以我認為這大大簡化了我們今後的工作。我們將繼續保持 LTC 團隊的獨立性，並且我們正在擴大該團隊的規模。我們一直有一個快速成長的細分市場。因此，我們很高興能夠透過神經心理團隊擴大對高潛力心理醫生和神經科醫生的覆蓋範圍，然後增加長期照護人員的數量。

The expansion with CRENESSITY is obviously smaller in scale. Our existing team is less than 50. So this is going to be a relatively smaller expansion, but it does allow us to go deeper especially in those community endocrinology practices and ultimately to accelerate adoption in classic CAH and help more patients faster.

與 CRENESSITY 的擴張規模顯然較小。我們現有團隊人數不到50人。因此，這將是一次相對較小的擴張，但它確實使我們能夠更深入地了解社區內分泌實踐，並最終加速經典 CAH 的採用，更快地幫助更多患者。

This is really a reflection of our belief in the TD market, an opportunity that we have ahead. Eric's track record here, this is probably our fourth expansion. Every time we've done it, we've seen a tremendous response and the team has done a great job driving more patients onto therapy.

這真正體現了我們對TD市場的信心，以及我們面前的機會。以艾瑞克的過往業績來看，這可能是我們的第四次擴張了。每次我們這樣做，都看到了巨大的反響，團隊在引導更多患者接受治療方面做得非常出色。

So I would look at this investment as clearly being to accelerate the market development and to maximize the number of patients on therapy, and we feel fortunate to have two great medicines to do this with.

因此，我認為這項投資的目的顯然是為了加速市場發展，最大限度地增加接受治療的患者人數，我們很幸運擁有兩種優秀的藥物來實現這一目標。

Jay Olson, Oppenheimer.

傑伊·奧爾森，奧本海默。

Congrats on the quarter. We have a pipeline question related to direclidine. As you look at potential indications beyond schizophrenia and bipolar, are you considering Alzheimer's psychosis? And are there any particular lessons you expect to learn from the Cobenfy Phase III study in Alzheimer's when that study reads out and any potential read across to direclidine?

恭喜你本季取得佳績。我們有一個與direclidine相關的管道問題。在考慮精神分裂症和雙相情感障礙以外的潛在症狀時，您是否考慮過阿茲海默症引起的精神病？當 Cobenfy 治療阿茲海默症的 III 期研究結果公佈時，您期望從中吸取哪些特別的經驗教訓，以及這些經驗教訓是否有可能推廣到 direclidine 上？

Yes. Thank you so much for the question. So as you mentioned, with 568 or direclidine, we're targeting our Phase III program, schizophrenia. We have initiated a Phase II bipolar mania study, that's this year. We're also very interested in Alzheimer's disease psychosis. We do have a pretty robust muscarinic portfolio, and indeed, we'll unveil that at R&D Day in December. But we have a lot of options in terms of which molecule we use, M1 preferring, M4 preferring, dual agonist for various indications.

是的。非常感謝您的提問。正如您所提到的，我們使用 568 或 direclidine，目標是我們的 III 期項目，治療精神分裂症。我們已啟動一項針對雙極性情感障礙躁症的 II 期研究，就在今年。我們對阿茲海默症引起的精神病也很感興趣。我們確實擁有相當強大的毒蕈鹼類藥物產品組合，事實上，我們將在 12 月的研發日上公佈這些產品。但是，在使用哪種分子方面，我們有很多選擇，例如 M1 優先型、M4 優先型、針對各種適應症的雙重激動劑。

So at the moment, we're thinking about AD psychosis for one of our follow-on molecules, which has particular advantages with respect to safety considerations in the elderly. Yes, we'll be watching BMS' Cobenfy data very closely. Our understanding is that their ADEPT Phase III study will be reading out relatively soon. They're going to be lessons learned, I think, for the whole field.

所以目前，我們正在考慮將 AD 精神病作為我們後續分子之一的治療目標，這對於老年人的安全考慮具有特別的優勢。是的，我們會密切關注BMS的Cobenfy數據。據我們了解，他們的 ADEPT III 期研究結果將很快公佈。我認為，這些都將成為整個領域需要學習的教訓。

David Amsellem, Piper Sandler.

大衛·阿姆塞勒姆，派珀·桑德勒。

Hey, thanks. So I wanted to come back to the sales force expansion for INGREZZA. So you've had a number of sales force expansions over the years over the commercial life of the product. So I guess with that in mind, at what point do you think this commercial organization is going to be rightsized?

嘿，謝謝。所以我想回到 INGREZZA 的銷售團隊擴張問題。在產品的商業生命週期內，你們已經多次擴充銷售團隊。所以我想，考慮到這一點，您認為這家商業機構會在什麼時候進行規模調整呢？

And also, at what point do you think the level of DTC spend is going to be rightsized? In other words, when do we start to see more aggressive margin expansion associated with the product?

另外，您認為DTC（直接面向消費者）的消費水準何時才能達到合理規模？換句話說，我們什麼時候才能看到該產品利潤率出現更積極的擴張？

So on the margin expansion, we've made tremendous progress over the last five years being in the low 50% range all the way down to this year, we should be in the low 40% range. And growing revenue to almost $800 million this quarter is just a testament to the investments as well as the markets that we're playing in. So when will we be 100% rightsized? We always invest as much as we can to pull as much revenue forward in any of these situations, and we're learning a lot as we go with the TD market.

因此，在利潤率擴張方面，過去五年我們取得了巨大的進步，利潤率一直維持在 50% 左右，而今年我們應該可以達到 40% 左右。本季營收成長至近 8 億美元，這充分證明了我們所進行的投資以及我們所處的市場環境的成功。那麼，我們什麼時候才能達到100%的合理規模呢？在任何情況下，我們都會盡可能多地投資，以期獲得盡可能多的收入，而且我們在TD市場的發展過程中也學到了很多東西。

But overall, from a margin expansion perspective, we look into the last part of this decade as being in a place where we'll continue to drive leverage, albeit maybe not as much as what had been anticipated in '26, but it's really with an eye to maximize the number of patients on therapy heading into the '27 to '29 window.

但總體而言，從利潤率擴張的角度來看，我們認為本十年後半段我們將繼續提高槓桿率，儘管可能不如 2026 年預期的那樣高，但我們的目標是在 2027 年至 2029 年期間最大限度地增加接受治療的患者人數。

Maybe I'll just add there to that. I think we touched on this already, but the INGREZZA market as it relates to TD is an incredibly robust growth engine for the company. And as much as we lean on the performance of the medicine, we're still only treating 10% of the 800,000 patients that are out there. And that was with the backdrop of the TD prevalence continuing to increase at the rate of growth of the antipsychotics, which is 3% to 4% per year, which is 3 to 4 times greater than the general population.

或許我會在那裡補充一些內容。我想我們已經談到過這一點了，但就 TD 而言，INGREZZA 市場是該公司極其強勁的成長引擎。儘管我們非常依賴藥物的療效，但我們仍然只治療了 80 萬名患者中的 10%。同時，TD 盛行率持續成長，其成長速度與抗精神病藥物的成長速度一樣，每年成長 3% 至 4%，是一般人群的 3 至 4 倍。

You put all those pieces together; the number of prescribers increases year-to-year as well. It's increasing faster than we've expanded the sales force over the years. In fact, I believe the past two years, the prescriber base has increased by 30%. So as much as we have looked at ways of reaching all of these patients and prescribers over time, the current structure of our sales organization is actually smaller than some of the companies out there with products just within schizophrenia.

把所有這些因素綜合起來看，處方醫生的數量也逐年增加。它的成長速度比我們這些年來銷售團隊的擴張速度還要快。事實上，我認為在過去兩年裡，處方醫生的數量增加了 30%。儘管我們一直在研究如何接觸所有這些患者和處方醫生，但目前我們銷售組織的結構實際上比一些專門從事精神分裂症產品的公司要小。

So we like where we're headed to right now, but it's still an organization that is rightsized for tardive dyskinesia and not so much for some of these larger psychiatry indications. And I think this is a step that not only helps us with INGREZZA, but as Eric said in his opening remarks, sets the stage quite well for us as we look at osavampator and direclidine in Phase III and their potential launch in the second half of this decade.

所以我們對目前的發展方向很滿意，但這個組織仍然只適合治療遲發性運動障礙，而不太適合治療一些較嚴重的精神科疾病。我認為這不僅對我們推進 INGREZZA 的研發有所幫助，而且正如 Eric 在開場白中所說，也為我們研究 osavampator 和 direclidine 的 III 期臨床試驗以及它們在本十年下半葉的潛在上市奠定了良好的基礎。

Brian Skorney, Baird.

Brian Skorney，Baird。

This is Luke on for Brian. On the upcoming 770 readout, can you talk about your expectations for the data? And what type of result in your view would support a confirmatory Phase II as compared to moving right into pivotal?

這是盧克替布萊恩報道。關於即將發布的 770 數據，您能否談談您對數據的預期？您認為什麼樣的結果才能支持進行驗證性 II 期臨床試驗，而不是直接進入關鍵性試驗？

Yes. So we are expecting the results of the Phase II study for 770, that's an NR2B NAM, this quarter. Just a context, the Phase II is a relatively small signal finding study, so 72 patients total, with three active arms as well as placebo. So I think the likelihood is that we would go into confirmatory Phase IIb if the results we see are encouraging. But we won't discount going to Phase III at this moment.

是的。因此，我們預計本季將公佈 770 的 II 期研究結果，該藥物屬於 NR2B NAM。簡單介紹一下背景，II 期研究是一項規模相對較小的訊號發現研究，總共有 72 名患者，分為三個活性治療組和一個安慰劑組。所以我認為，如果我們看到的結果令人鼓舞，我們很可能會進入確認性 IIb 期試驗。但我們目前不會排除進入第三階段的可能性。

In terms of, frankly, what we'd like to see, we would like to see esketamine-like efficacy, not too dissimilar from SPRAVATO, but without the baggage of some of the associated side effects, which mandate a 2-hour in-house observation period post dose. But I guess we'll see what we see later this quarter.

坦白說，我們希望看到類似艾司氯胺酮的療效，與 SPRAVATO 的療效不要有太大差別，但又沒有 SPRAVATO 的一些相關副作用，這些副作用需要在給藥後進行 2 小時的院內觀察。但我想我們得等到本季晚些時候才能看到結果。

All right, thank you.

好的，謝謝。

Brian Abrams, RBC Capital Markets.

Brian Abrams，加拿大皇家銀行資本市場。

Hey guys, congrats on the quarter. I was wondering if you could talk a little bit more about CRENESSITY persistence, just now that you're several quarters in. Can you be any more specific on in terms of what you're seeing there? And then just the overall KOL feedback around patients who started on the drug early in the launch and the glucocorticoid equilibration at this point now that patients have been on drug for many months.

嘿，夥計們，恭喜你們本季取得佳績。我想請您再多談談 CRENESSITY 的持續性，畢竟您已經營運了好幾個季度了。您能更具體地描述一下您在那裡看到了什麼嗎？然後，我們收集了 KOL 對早期開始服用該藥物的患者的總體反饋，以及患者服用該藥物數月後糖皮質激素的平衡情況。

Yes. I mean the way that I would characterize it is that CRENESSITY's persistence and compliance has been really strong. And certainly, we were hopeful going into the launch that we would see this kind of overall adherence to medication based on our experience in the double-blind studies and the open-label extensions.

是的。我的意思是，CRENESSITY 的堅持和合規性真的非常強。當然，在產品上市之初，我們根據雙盲研究和開放標籤擴展研究的經驗，希望能夠看到這種整體的用藥依從性。

But the vast majority of people that are starting treatment are -- in the earlier parts of the year are still on treatment. In terms of the feedback on the reduction of GCs, obviously, you all have done your doc calls, you're probably hearing the same kind of thing that we're hearing. Patients are on treatment for a period of time.

但絕大多數在年初開始接受治療的人仍在接受治療。關於減少總法律顧問的回饋，顯然，你們都已經進行了文件審查，你們聽到的可能和我們聽到的差不多。患者需要接受一段時間的治療。

Doctors want to see how they can reduce the androgens and then they start the process of tapering down the GCs, and it varies a little bit from provider to provider and also, I think, is dependent on the particular situation of the patient. But overall, we're seeing really good feedback in terms of both disease control with the androgen reductions and also the opportunity to really bring down those GCs to more physiologic or near physiologic levels.

醫生們想看看如何降低雄激素水平，然後開始逐步減少糖皮質激素的用量，這因醫生而異，而且我認為，也取決於患者的具體情況。但總的來說，我們看到，無論是透過降低雄性激素水平來控制疾病，還是有機會真正將糖皮質激素降低到更接近生理水平，都獲得了非常好的回饋。

Marc Goodman, Leerink Partners.

馬克古德曼，Leerink Partners。

Yes. Matt, at the beginning of the year, you were pretty conservative with respect to the CRENESSITY launch. I think your main issue, if I remember, was just reimbursement concerns and how quickly that would be adopted. Obviously, that's been adopted way better than anybody could have expected, I suppose.

是的。Matt，年初的時候，你對 CRENESSITY 的發布採取了相當保守的態度。我記得，你當時的主要問題好像是報銷問題以及這項措施能否迅速得到落實。顯然，這項措施的實施效果遠遠超出任何人的預期。

So how do we think about gross to nets now? I mean they clearly have come down a lot, just working through the numbers. Are we continuing to move lower quite a bit outside of maybe the first quarter next year just because first quarter is unusual? But if you think about the next three, four quarters, are they just going to continue to come down and ramp down to more normalized levels for what we consider an orphan product like this?

那我們現在該如何看待毛利潤與淨利之間的關係呢？我的意思是，很明顯，這些數字已經下降了很多。除了明年第一季之外，我們是否會繼續大幅下跌，只因為第一季情況特別？但如果你考慮接下來的三到四個季度，對於我們眼中的這種孤兒產品來說，它們的銷量是否會繼續下降，並逐漸降至更正常的水平？

Marc, that's quite fair. In terms of a guide for gross to net, I would just characterize it as being less than a 20% gross to net discount and that's something that -- in the foreseeable future, that's something we would be anticipating. Part of the gross to net dynamics has to do with the nature of the patients. They're primarily commercial, but we also have a base of Medicaid patients, so you pay the statutory rebate.

馬克，你說得很有道理。就毛利與淨利的比值而言，我只能說毛利與淨利的比值折扣不到 20%，而且在可預見的未來，我們預計這種情況將會發生。總收入與淨收入之間的動態變化部分與患者的性質有關。它們主要針對商業客戶，但我們也有一部分醫療補助患者，所以您需要支付法定退款。

But overall, the rate of reimbursement, as you mentioned, it's above 80%. As Eric said, nine out of 10 patients have ultimately ended up with an adjudicated claim. So I feel quite strong with where we're at and reaching a pretty darn good level in terms of how we think about the future.

但正如您所提到的，整體報銷率在 80% 以上。正如艾瑞克所說，十個病人中有九個最終都獲得了賠償。所以我對我們目前所處的位置感到非常滿意，並且在我們對未來的思考方面已經達到了相當不錯的水平。

Sean Laaman, Morgan Stanley.

肖恩拉曼，摩根士丹利。

Thank you, and hi, Kyle and team. Hope everyone's well. Maybe just circling back on INGREZZA. But can you comment on neurology versus the psych split? And is it a focus on psych to the expense of neurology? I think I heard AUSTEDO had a strong uptake in neurology, especially during COVID? And what are your plans for neurology?

謝謝，你好，Kyle和團隊。希望大家都好。或許只是再回到 INGREZZA 這個話題。您能否談談神經學與心理學的差異？是否過度注重心理學而忽略了神經學？我好像聽說A​​USTEDO在神經學領域很受歡迎，尤其是在新冠疫情期間？你對神經病學有什麼規劃？

Yes. Neurology represents about 15% of our total volume. Obviously, all of the business segments, neurology, psychiatry and LTC have been growing like gangbusters this year, in particular. But on a relative basis, it's now the smallest segment that we have. And we view it as important, but it doesn't have the same kind of patient potential that we see in psychiatry.

是的。神經科門診量約占我們總門診量的15%。顯然，今年所有業務板塊，特別是神經病學、精神病學和長期護理，都發展迅速。但相對而言，它現在是我們最小的細分市場。我們認為它很重要，但它不像精神病學那樣具有同樣的患者潛力。

As I said in my prepared remarks, the fastest-growing segment is really advanced practice providers that are in behavioral health. And so this reorganization and kind of combining our teams across psychiatry and neurology sort of puts our resources where we see the highest growth potential.

正如我在準備好的演講稿中所說，成長最快的群體是行為健康領域的高級執業人員。因此，此次重組以及將我們在精神病學和神經病學領域的團隊合併，可以將我們的資源投入到我們認為成長潛力最大的領域。

And behaviorally, the psychiatry segment and the neurology segment are more similar to each other than LTC. And so we're keeping LTC separate, expanding that team. We're combining our psych and neurology teams and then expanding that team. And ultimately, we want to make sure that we can keep up with the pace of this market that's very fast growing and continue to drive new patient starts. This is an investment in growth, as we said, and we really like the trajectory that we're on now.

從行為學角度來看，精神病學部分和神經病學部分之間的相似度比長期照護更高。因此，我們將 LTC 保持獨立，並擴大該團隊。我們將合併心理學和神經病學團隊，然後擴大該團隊的規模。最終，我們希望確保能夠跟上這個快速成長的市場步伐，並繼續推動新患者的加入。正如我們所說，這是一項對成長的投資，我們非常滿意我們目前的發展軌跡。

Maybe just to add to that real quickly on the neuro piece. Just keep in mind, a lot of interest has come from the side of the chorea side of the indication opportunity with INGREZZA. For HD chorea, there are about 30,000 patients in the US, about 90% have chorea.

或許我只想快速補充神經科學的知識。請記住，人們對 INGREZZA 的適應症機會，在舞蹈症方面引起了廣泛關注。美國約有 3 萬名 HD 舞蹈症患者，其中約 90% 患有舞蹈症。

So that 20,000 number is about a 40:1 ratio to the TD patients that we see out there today. So I think that speaks to some of the volume flow that we see across the neuro and psych piece and that's something that we keep in mind as we look at for their investments down the road.

所以，這 20,000 個數字與我們今天看到的 TD 患者的數量大約是 40:1 的比例。所以我認為這反映了我們在神經和心理學領域看到的一些交易量變化，這也是我們在考慮他們未來的投資時會牢記在心的一點。

Yigal Nochomovitz, Citi.

Yigal Nochomovitz，花旗集團。

Alright, great, thank you very much for taking the question. I had one on capital management. You mentioned, obviously, the increase in SG&A of about $150 million to expand both sales forces. So with that in mind, I'm just curious how are you thinking about the continuation of the buyback at the pace of that buyback related to the new $500 million buyback allocation?

好的，太好了，非常感謝您回答這個問題。我做過一個關於資本管理的測試。顯然，您提到了銷售、一般及行政費用增加了約 1.5 億美元，以擴大銷售團隊。考慮到這一點，我很好奇您如何看待繼續以目前的速度回購股票，以及這與新的 5 億美元回購撥款之間的關係？

Yes. So we have $2.1 billion in cash right now, no debt. We're profitable. Where we're putting the capital right now is prioritizing top line growth as well as investing in R&D at 35% is what our target range is. We, of course, have flexibility to do share buyback. But I would say that our bias is to utilize our capital to -- for business development activities. But right now, focused on driving our own internal initiatives.

是的。所以我們目前有21億美元的現金，沒有債務。我們獲利了。我們目前將資金投入的重點是提高營收，同時將研發投入目標比例設定為 35%。當然，我們也有回購股票的彈性。但我認為，我們的傾向是利用我們的資本進行業務發展活動。但目前，我們專注於推進我們自己的內部專案。

Thank you.

謝謝。

Corinne Johnson, Goldman Sachs.

科琳·約翰遜，高盛集團。

Yeah, good afternoon, guys. Maybe a question for us. Can you talk about where you stand with respect to share of kind of new to category or new to class patients with INGREZZA versus AUSTEDO? And where do you think that could go? Maybe contextualize that versus where we were a year ago and where you think we could go with the expanded sales force over kind of the next year?

好的，各位下午好。或許我們可以問你一個問題。您能否談談在 INGREZZA 與 AUSTEDO 相比，您在新類別或新類患者中所佔份額方面的情況？你覺得這件事會如何發展？或許可以結合一年前的情況，談談你認為隨著銷售團隊的擴充，我們未來一年能有怎樣的進展？

Yes. As Matt mentioned, the new patient starts or NRx in any given week or month are single-digit percent of total TRx. But they're critically important because of the persistency and compliance that these patients have on INGREZZA, that they represent a significant number of likely refills.

是的。正如 Matt 所提到的，任何一周或一個月內的新患者開始治療或 NRx 都只佔總 TRx 的個位數百分比。但由於這些患者對 INGREZZA 的堅持和依從性，他們代表著大量的潛在續藥量，因此他們至關重要。

And what we've seen really since the beginning of the year with the prior expansion of our field sales team and then the investment that we've made in increasing formulary coverage, particularly in the Medicare segment is that we're getting the majority of new patient starts, and that's really what's driving increased total market share from a patient perspective and that's really an important part of our strategy going forward.

自年初以來，隨著我們擴大現場銷售團隊，以及加大對擴大處方集覆蓋範圍（尤其是在醫療保險領域）的投資，我們看到，我們獲得了大部分新患者，這才是真正推動我們從患者角度獲得更大市場份額的原因，也是我們未來戰略的重要組成部分。

This momentum that we're carrying through '25 into '26, we want to make sure that we continue that into that critical time period of '27 and beyond. So the way I would look at it is we're gaining the majority of new patient starts now, and we intend to continue doing that going forward.

我們希望確保將2025年到2026年這段勢頭延續到2027年及以後的關鍵時期。所以我認為，我們現在獲得了大部分新患者，而且我們打算繼續這樣做。

Ash Verma, UBS.

阿什維爾馬，瑞銀集團。

Hi, thanks for doing your questions. I'm just trying to understand the medium-term growth outlook for INGREZZA given the sales force investment and the contracts that you've done. For the years before IRA impact, do you believe that you can grow at a higher pace versus where you've guided to this year?

您好，感謝您回答問題。我只是想了解一下，鑑於貴公司在銷售團隊方面的投入以及已簽訂的合同，INGREZZA 的中期成長前景如何。在 IRA 影響之前的幾年裡，您是否認為您的成長速度可以高於您今年預期的成長速度？

Yes. I guess the way that I would characterize that is that this year, the VMAT2 market is experiencing double-digit growth. And our brand is growing faster than the market. So we're really pleased with the growth trajectory that we're on. In fact, as we mentioned earlier, for Q3, that was -- that represented 12% year-over-year growth.

是的。我認為，今年 VMAT2 市場正經歷兩位數的成長。我們的品牌成長速度超過了市場平均。所以我們對目前的發展動能非常滿意。事實上，正如我們之前提到的，第三季年增了 12%。

So the goal is to continue and carry that forward into 2026 and beyond, and to maximize our patient share. We'll be able to give more color as we get closer to our Q4 earnings call and talk about the projections for 2026. But at this point, it looks like we'll be able to see a continuing strong, robust growing market for VMAT2s and INGREZZA in particular, next year and beyond.

因此，我們的目標是將這一目標延續到 2026 年及以後，並最大限度地提高我們的患者份額。隨著第四季財報電話會議的臨近，我們將能夠提供更多細節，並討論2026年的預測。但就目前來看，明年及以後，VMAT2 和 INGREZZA 的市場似乎將繼續保持強勁、穩健的成長動能。

Ami Fadia, Needham.

阿米法迪亞，尼德姆。

Hi, good afternoon. Thanks for taking my question. It's on NBI-'770. Given that this study is not necessarily powered for statistical significance, just on an absolute basis, what is the level of change in the primary endpoint that you're looking to see as you think about some of the other drugs, such as SPRAVATO or rather psychedelics in the space? And eventually, are you thinking of studying this in TRD or MDD? Just sort of current thoughts.

您好，下午好。謝謝您回答我的問題。它在 NBI-'770 上。鑑於這項研究不一定是為了達到統計意義，而只是為了達到絕對意義，那麼當您考慮其他一些藥物，例如 SPRAVATO 或該領域的迷幻藥時，您希望看到主要終點發生怎樣的變化？最終，您是否考慮過在難治性憂鬱症 (TRD) 或重度憂鬱症 (MDD) 領域進行研究？只是最近一些想法。

Yes, really good question. So yes, it's a relatively small study. So I'm hesitant to give an effect size that, frankly, we would be considered as successful versus not because I think there's a huge amount of unmet need in this population. As you mentioned, there are potentially two populations that we could target with 770.

是的，問得好。是的，這是一項規模相對較小的研究。因此，我不敢給出一個效應量，坦白說，這個效應量決定了我們是成功還是失敗，因為我認為這個群體中存在大量未被滿足的需求。正如您所提到的，我們可以使用 770 來靶向兩個潛在人群。

And one is adjunctive treatment in MDD, which is currently where the program is headed. But we clearly could go down the SPRAVATO route with respect to TRD as well with this mechanism. So we have a couple of options. We will decide that, I think, based on the data that we'll receive later this quarter.

其中之一是 MDD 的輔助治療，這也是該計畫目前的發展方向。但顯然，我們也可以透過這個機制，在 TRD 方面走 SPRAVATO 路線。所以我們有幾個選擇。我認為，我們將根據本季稍後收到的數據來決定。

Sumant Kulkarni, Canaccord.

Sumant Kulkarni，Canaccord。

Good afternoon. Thanks for taking my question. As the Inflation Reduction Act kicks in for your competitor, could you comment on where you might see the most impact on INGREZZA, either in terms of profile of patients or by prescriber type? And on the neuropsych side specifically, what might be the maximum number of products that you might be able to leverage the situation of your expanded neuropsych sales team?

午安.謝謝您回答我的問題。隨著《通貨膨脹削減法案》對您的競爭對手生效，您能否評論一下，您認為該法案對 INGREZZA 的影響可能在哪些方面最大，無論是患者群體還是處方醫生類型？具體到神經心理學方面，您擴大神經心理學銷售團隊規模後，最多可以銷售多少產品？

Yes, let me take the second part of your question here. We'd love to have the challenge of having three products into psychiatry and long-term care at the same time. Obviously, we're really excited about the late-stage pipeline with both direclidine and osavampator in Phase III trials.

好的，讓我來回答您問題的第二部分。我們很樂意接受挑戰，同時將三款產品推向精神科和長期照護領域。顯然，我們對處於後期研發階段的 direclidine 和 osavampator 都感到非常興奮，它們都已進入 III 期臨床試驗。

And as Kyle said in his prepared remarks, data and potential launches later in the latter half of this decade. This expansion that we're in the midst of now, I think sets us up well for being able to move and launch with either of those two products or potentially both.

正如凱爾在事先準備好的演講稿中所說，數據和潛在的發射將在本十年後半段進行。我認為，我們目前正在進行的這次擴張，為我們能夠推出這兩款產品中的任何一款，或者兩款產品都推出，奠定了良好的基礎。

So I would say that it's not sufficient, meaning, for example, if we end up having the opportunity to launch osavampator, we won't have the coverage of the primary care -- future primary care prescribers that we would need to reach. So this gets us partly the way there, but not fully. And so I do think it reduces the amount of changes that we would have to make to prepare for either of those two launches down the road.

所以我認為這還不夠，也就是說，例如，如果我們最終有機會推出 osavampator，我們將無法獲得初級保健的覆蓋範圍——我們需要接觸到的未來初級保健處方醫生。這樣我們就離目標更近了一步，但還沒有完全實現。因此，我認為這可以減少我們為未來這兩次發射做準備時需要做出的改變。

In terms of impact from the IRA and the negotiation, our view is that patients are -- existing patients are ultimately going to stay on therapy during this window of time. So you're thinking about a two-year window when you're dealing with new patients and where do they go. So a lot of what we're doing right now is to maximize the number of patients on therapy between now and 2027.

就 IRA 和談判的影響而言，我們的觀點是，患者——現有患者最終將在這段時間內繼續接受治療。所以，你正在考慮兩年的時間窗口，在此期間你會接觸到新患者，以及他們會去哪裡。因此，我們現在所做的許多工作都是為了在 2027 年之前最大限度地增加接受治療的患者人數。

And we're going to control every single thing that we can to maximize that number, and we think we'll be successful during that window of time. But we will learn more in terms of what the MFP is for AUSTEDO as well as payer behavior over the coming months. But for what we can control, we're doing everything we can possible. We have a great market with a great medicine here.

我們將控制一切可以控制的因素，以最大限度地提高這個數字，我們認為在這個時間段內我們會取得成功。但在接下來的幾個月裡，我們將更了解 MFP 對 AUSTEDO 的意義以及支付方的行為。但就我們能控制的方面而言，我們正在竭盡全力。我們這裡有很棒的市場，藥品種類也很豐富。

Yatin Suneja, Guggenheim.

Yatin Suneja，古根漢美術館。

Thank you for taking my question. Matt, one clarification, the 14-week dynamic or one extra week dynamic, that is just specific to INGREZZA? And then if you can just comment also on the inventory, if you can, for CRENESSITY.

感謝您回答我的問題。Matt，我有個疑問，14 週的週期或額外一週的周期，是 INGREZZA 特有的嗎？如果您可以的話，也請對 CRENESSITY 的庫存發表一些評論。

Yes. CRENESSITY inventory build was about $7 million for the quarter. And then as it relates to the 14 week, that does pertain to INGREZZA primarily. And you can assume that was almost a full week of impact on the quarter. So when you want to normalize Q3 to think about trajectory into Q4, I think it's safe to assume remove the week and then you can grow off of that base from there.

是的。CRENESSITY 本季庫存增加約 700 萬美元。至於第 14 週，主要與 INGREZZA 有關。你可以推斷，這幾乎對本季造成了一整週的影響。所以，當你想要對第三季進行標準化處理，以便考慮第四季度的發展軌跡時，我認為可以安全地假設去掉第三季的一周，然後就可以以此為基礎進行成長。

Myles Minter, William Blair.

邁爾斯·明特，威廉·布萊爾。

Hey, thanks for taking the question. This one is just on CRENESSITY new starts. I think in the second quarter, you had 664. You got 540 this quarter. So some sort of warehousing effect that's bleeding out of those patients. Can we expect that sort of trajectory for the next quarter and maybe a return to growth when you get that sales force expansion hitting into the new year?

嘿，謝謝你回答這個問題。這只是針對 CRENESSITY 新用戶的。我認為第二季你們有 664 人。你這季得了540分。所以，某種程度上存在著一種儲存效應，導致這些患者的病情逐漸惡化。我們能否預期下一季也能維持這種成長勢頭，並且隨著銷售團隊在新年伊始的擴張，或許能夠恢復成長？

Yes. The way I would characterize the adoption in Q3 was that very consistent and steady. We said this would be a measured launch. And so far, it has played out that way. Although the overall rate of adoption, I think, since day one has been a little bit quicker than what we anticipated prior to the launch.

是的。第三季的產品採用情況可以用「非常穩定」來形容。我們說過這將是一次穩步推進的發布。目前來看，事情的確是這樣發展的。雖然我認為，從第一天起，整體採用率就比我們發布前預期的要快一些。

We were helped out a little bit in Q2 by the wind down of the adult open-label study. And so there were some patients that transitioned towards the end of Q2 to commercial drug that bumped up numbers a little bit. But overall, I'd say that the rate of weekly enrollments has been pretty consistent across both Q2 and Q3.

第二季度，成人開放標籤研究的結束對我們有幫助。因此，在第二季末，一些患者轉而使用商業藥物，這使得數據略有上升。但總的來說，我認為第二季和第三季的每週註冊人數都相當穩定。

Maybe I'll just add here quickly. The launch continues to exceed our expectations, and that's across the board, enrollment forms, persistence, compliance and that's played out here ultimately. As time moves along, the combination of the steady adoption of CRENESSITY as well as the persistency is going to stack volume over time and gives us all the confidence that we have a need for this to be our next blockbuster here.

或許我在這裡簡單補充一下。這次發表會持續超出我們的預期，各方面都如此，包括註冊表格、用戶留存率、合規性等等，最終都體現在這裡。隨著時間的推移，CRENESSITY 的穩步普及以及堅持不懈的努力，將會隨著時間的推移積累銷量，並讓我們確信，它將成為我們下一個重磅產品。

Awesome, thanks guys.

太棒了，謝謝各位。

Danielle Brill, Truist.

Danielle Brill，Truist。

This is Alex on for Danielle. Thanks for taking the question. Another one on CRENESSITY. Just curious if you're seeing any new -- any shift in the new prescription breakdown between pediatrics and adult? And additionally, any trends in the usage of the free drug program?

這裡是Alex替Danielle報道。感謝您回答這個問題。CRENESSITY 上還有一篇。我只是好奇您是否觀察到兒科和成人新處方比例有任何變化？此外，免費藥物計劃的使用情況有何趨勢？

No major shifts from the demographic perspective. It still is skewing towards younger patients and primarily towards female patients. That pattern kind of kicked in after about a quarter or so on the market, and it's been pretty steady ever since. And then what was the second half of your question, I'm sorry?

從人口結構角度來看，沒有重大變化。患者群仍以年輕患者為主，且主要以女性患者為主。這種模式在上市大約一個季度後開始出現，並且從那時起一直相當穩定。那麼，不好意思，您問題的後半部是什麼來著？

Just on --

就在--

That was on the drug part?

那是關於毒品的那部分嗎？

Yes.

是的。

Yes. It's actually continues to be less than what we had anticipated it would be. The idea being that if insurance hadn't approved the claim after about a week, that we would be able to offer a month supply of CRENESSITY to get someone started pretty quickly.

是的。實際上，實際數字仍然低於我們的預期。我們的想法是，如果保險公司在一周左右的時間內沒有批准索賠，我們就可以提供一個月的 CRENESSITY 產品，讓患者能夠很快開始使用。

And as I mentioned earlier, nine out of 10 patients that are on CRENESSITY have gotten their prescription approved through their insurance. And so not that many people end up on the free drug program, to be honest with you.

正如我之前提到的，10 名服用 CRENESSITY 的患者中有 9 名通過保險獲得了處方批准。說實話，所以最終能參加免費藥物計畫的人並不多。

Laura Chico, Wedbush Securities.

Laura Chico，Wedbush Securities。

Good afternoon. Thanks very much. One of the pipeline with respect to valbenazine and dyskinetic cerebral palsy. The data coming up here. Can you talk a little bit more about what will constitute a meaningful change in chorea score in a CP population? But also, I guess, against the backdrop of the INGREZZA field force expansion, how should we think about the size of the opportunity and overlap with existing INGREZZA prescribers?

午安.非常感謝。其中一條關於纈苯那嗪治療運動障礙型腦性麻痺的研發管線。這裡顯示的數據。能否再詳細談談，對於腦性麻痺患者族群而言，舞蹈症評分發生哪些有意義的變化才算合格？但我想，在 INGREZZA 銷售隊伍擴張的背景下，我們應該如何看待此次機會的規模以及與現有 INGREZZA 處方醫生的重疊情況呢？

Yes, I'll do the first question really quickly, and I'll hand on for the second. So this population of dyskinetic cerebral palsy doesn't have a priori-validated scale. So essentially, we're borrowing from the UHDRS, Huntington's scale. That's a total maximum chorea scale. Our assumption is that typically a significant effect in that would be meaningful enough. Clearly, we'll be seeing the totality of the data later this quarter.

好的，我會很快回答第一個問題，第二個問題就交給你們了。因此，對於運動障礙型腦性麻痺患者族群，目前還沒有預先驗證的評估標準。所以本質上，我們借鏡了 UHDRS 和亨廷頓氏症的量表。這是舞蹈症的最高等級。我們的假設是，通常情況下，這種顯著的影響就足夠有意義了。顯然，我們將在本季稍後看到全部數據。

And maybe -- this is Kyle. Just to add to next steps on this. We would take a data set if it was robust to the agency and ensure that there's a path forward for an NDA submission. And with the current size and composition of the sales force, we would be covered there in case that was an sNDA.

或許——這就是凱爾。補充一下後續步驟。如果資料集對機構而言足夠可靠，我們將採用該資料集，並確保有辦法提交保密協議。以我們目前的銷售團隊規模和組成，即使涉及保密協議，我們也能應對。

This is Eric. The last thing, I'll chime in here. The DCP population is larger than the Huntington's chorea population, but still substantially smaller than the TD population. And the expanded sales team, if this turned into an indication down the road, would be able to cover all the potential prescribers.

這是埃里克。最後，我再補充一點。DCP 患者數量比亨廷頓舞蹈症患者數量多，但仍比 TD 患者數量少得多。如果這種情況在未來得到證實，那麼擴大的銷售團隊將能夠涵蓋所有潛在的處方醫生。

Thanks very much.

非常感謝。

David Hoang, Deutsche Bank.

David Hoang，德意志銀行。

Hi there, thanks for fitting me in and taking my question. So again, congrats on a strong quarter. I saw you have reiterated but not raised guidance. So I guess you mentioned the extra week in Q3 for ordering, but we think about the -- what the Q4 number may look like, I think the guide implies something to like down mid-single digits to flattish.

您好，感謝您抽空回答我的問題。再次恭喜你們本季業績出色。我看到你重申了指導方針，但沒有提出新的指導方針。所以我想你提到了第三季度多出的一周訂購時間，但是我們考慮的是——第四季度的數字可能會是什麼樣子，我認為指南暗示可能會下降到個位數中段或基本持平。

Anything else to think about in there in terms of maybe whether you envision seasonal dynamics or perhaps there's some degree of embedded conservatism?

還有其他需要考慮的因素嗎？例如你是否考慮到了季節性因素，或者其中是否包含某種程度的保守主義？

Yes. If you back out the 14th week, I think it gets you into a place to grow off of. And then sequentially, what you've seen over the last handful of years is the fourth quarter typically will have a range of $15 million to $20 million of sequential growth.

是的。如果你跳過第 14 週，我認為這能讓你有一個可以繼續進步的空間。然後，從過去幾年的情況來看，第四季通常會有 1500 萬美元到 2000 萬美元的環比增長。

So my recommendation, David, is to normalize Q3 to a 13-week and then think about that type of a growth trajectory. Price should be pretty consistent. It was down 6% to 7% year-over-year in the third quarter. That should be something that you would experience in Q4 as well. So nothing abnormal on the pricing side.

所以我的建議是，David，將第三季的數據標準化為 13 週，然後考慮這種成長軌跡。價格應該會比較穩定。第三季年減 6% 至 7%。這也應該是你在第四季會遇到的情況。所以價格方面一切正常。

Evan Seigerman, BMO Capital Markets.

Evan Seigerman，BMO資本市場。

Hi guys, thank you so much for taking my question. In your 10-Q filed today, there was a disclosure about the Make America Healthy Again commission issuing warning letters regarding DTC advertisements. You indicated that you got one for INGREZZA. Can you talk about what was in that letter and what you might need to correct given that, that is pretty important when it comes to the commercial plan for that asset?Thank you very much.

大家好，非常感謝你們回答我的問題。在您今天提交的 10-Q 文件中，披露了“讓美國再次健康”委員會就 DTC 廣告發出警告信一事。你表示你收到了一個 INGREZZA。您能否談談那封信的內容以及您可能需要修改的地方？這對於該資產的商業計劃至關重要。謝謝。非常感謝。

Yes, I'll take this question. This is Kyle. I think many of us in the industry received a similar letter with similar types of contents in there. I think what a good view to have on this as a pharma member is we're committed to conducting responsible advertising for us. It is an important part of our business.

好的，我來回答這個問題。這是凱爾。我想我們業內很多人都收到了內容類似的信件。我認為身為醫藥產業的一員，我們應該秉持的好理念是，我們致力於進行負責任的廣告宣傳。這是我們業務的重要組成部分。

We think it's a good opportunity for us to reach patients and also educate out there. We'll continue to look at that as an opportunity. But rest assured, we continue to do this in a responsible way, and we'll look to continue doing that moving forward.

我們認為這是一個很好的機會，可以接觸到患者，並進行科普教育。我們將繼續把這視為一個機會。但請放心，我們將繼續以負責任的方式進行這項工作，並且我們將繼續努力做到這一點。

And this does conclude today's question-and-answer session. I will now turn the call over to Kyle Gano for any additional or closing remarks.

今天的問答環節到此結束。現在我將把電話交給凱爾·加諾，讓他補充或作總結發言。

Thank you, and thanks, everyone, for the good discussion and call this afternoon. Looking ahead, we are confident in the company's direction and momentum. We hope you can see here today that we're executing with clarity and discipline. Expanding two commercial franchises in INGREZZA and CRENESSITY, advancing a robust and growing pipeline. We talked about some of our mid- to late-stage assets today and investing in the next generation of innovation. This is what Neurocrine is about today and in the future.

謝謝大家，也謝謝各位今天下午的精彩討論與通話。展望未來，我們對公司的發展方向和動能充滿信心。我們希望大家今天能夠看到，我們正在以清晰的思路和嚴謹的紀律執行各項任務。拓展 INGREZZA 和 CRENESSITY 兩家商業特許經營店，推動穩健且不斷成長的業務發展。今天我們討論了一些處於中後期階段的資產，以及對下一代創新技術的投資。這就是Neurocrine現在和未來的發展方向。

It goes without saying we look forward to meeting with many of you at the upcoming and remaining conferences this year and certainly at our R&D Day on December 16. Thanks again.

毋庸置疑，我們期待在今年即將舉行的以及剩餘的會議上與各位見面，當然也期待在 12 月 16 日的研發日上與大家見面。再次感謝。

This does conclude today's program. Thank you for your participation. You may disconnect at any time.

今天的節目到此結束。感謝您的參與。您可以隨時斷開連線。