Neurocrine Biosciences Inc (NBIX) 2025 Q2 法說會逐字稿

Good day, everyone, and welcome to Neurocrine Biosciences second-quarter 2025 results conference.. (Operator Instructions)

大家好，歡迎參加 Neurocrine Biosciences 2025 年第二季業績發表會。（操作員指示）

Please note this call may be recorded and I will be standing by if you should need any assistance. It is now my pleasure to turn the conference over to Vice President of Investor Relations, Todd Tushla. Please go ahead, sir.

請注意，本次通話可能會被錄音，如果您需要任何協助，我將隨時待命。現在我很高興將會議交給投資者關係副總裁 Todd Tushla。先生，請繼續。

Thank you and happy Wednesday, everyone. Welcome to Neurocrine Biosciences' second-quarter 2025 earnings call. With me today are Kyle Gano, Chief Executive Officer; Matt Abernethy, Chief Financial Officer; Eric Benevich, Chief Commercial Officer; Eiry Roberts; and for first time as Chief Medical Officer, Sanjay Keswani.

謝謝大家，祝大家週三快樂。歡迎參加 Neurocrine Biosciences 2025 年第二季財報電話會議。今天與我一起的有執行長 Kyle Gano、財務長 Matt Abernethy、首席商務官 Eric Benevich、Eiry Roberts，以及首次擔任首席醫療官的 Sanjay Keswani。

During today's 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, we will jump into Q&A. I now turn the call over to Kyle.

在今天的電話會議中，我們將做出前瞻性的陳述。這些聲明受一定風險和不確定性的影響，我們的實際結果可能有重大差異。我鼓勵您查看我們最新的 SEC 文件中討論的風險因素。準備好發言後，我們將進入問答環節。現在我把電話轉給凱爾。

Thank you, Todd. Good afternoon, everyone. We were especially pleased with our standout second quarter that delivered high double-digit growth. We showcased our diversified revenue profile and highlighted the organization's ongoing evolution. From a commercial perspective, our INGREZZA-based business continues to post solid growth, and we are excited by the strong early performance of CRENESSITY.

謝謝你，托德。大家下午好。我們對第二季的出色表現感到特別高興，實現了兩位數的高成長。我們展示了我們多元化的收入狀況並強調了組織的持續發展。從商業角度來看，我們基於 INGREZZA 的業務繼續保持穩健成長，我們對 CRENESSITY 的強勁早期表現感到興奮。

For INGREZZA, our strategic investments to enhance payer access led to another record of new patient starts and TRx for the quarter, further strengthening our leadership in the VMAT2 class. We remain confident that these market access initiatives will continue to drive long-term growth for the INGREZZA franchise.

對於 INGREZZA 而言，我們為增強付款人訪問權限而進行的策略性投資，使得本季度新患者開始數量和 TRx 數量再創紀錄，進一步鞏固了我們在 VMAT2 領域的領先地位。我們堅信這些市場准入措施將繼續推動 INGREZZA 特許經營的長期成長。

For CRENESSITY, we once again outperform internal expectations. To date, CRENESSITY has been well received by both patients and prescribers, underscoring the significant unmet needs within the classical congenital adrenal hyperplasia community. With a strong product profile across efficacy, safety, and tolerability, we believe CRENESSITY is well positioned to become the standard of care for patients with classical CAH and has all the attributes to be Neurocrines' second commercial blockbuster.

對於 CRENESSITY 而言，我們再次超出了內部預期。迄今為止，CRENESSITY 已受到患者和處方者的一致好評，凸顯了經典先天性腎上腺增生症群體中尚未滿足的重大需求。憑藉在功效、安全性和耐受性方面的強大產品特性，我們相信 CRENESSITY 完全有能力成為經典 CAH 患者的護理標準，並具備成為 Neurocrines 的第二個商業重磅炸彈的所有屬性。

Coming off a successful ENDO conference this month, I'm reminded how far we've come. In fact, it was back in March of 2015 at ENDO that we first presented proof-of-concept data in CAH with a CRF receptor antagonist.

本月成功舉辦了 ENDO 會議後，我意識到我們已經取得了多大的進步。事實上，早在 2015 年 3 月，我們就在 ENDO 首次展示了使用 CRF 受體拮抗劑治療 CAH 的概念驗證數據。

This year, over a decade later, I had the opportunity to meet directly with clinicians in the field, which gave me an even deeper appreciation for the impact we are making for CAH patients and for the importance of the work we do every day at Neurocrine.

十多年後的今年，我有機會直接與該領域的臨床醫生見面，這讓我更加深刻地認識到我們為 CAH 患者帶來的影響以及我們每天在 Neurocrine 所做工作的重要性。

Putting patients at the center isn't just the guiding principle, it's what drives meaningful progress. It goes without saying, we're deeply grateful to the patients, their caregivers, and families, and investigators who made this progress possible in partnership with the Neurocrine team. We look forward to our continued collaboration.

以病人為中心不僅是指導原則，也是推動有意義進步的動力。毋庸置疑，我們深深感謝患者、他們的照護者、家人以及與 Neurocrine 團隊合作取得這項進展的研究人員。我們期待繼續合作。

Turning to the clinical pipeline, we believe we have one of the industry's deepest, diversified neuroscience-focused pipelines. I would like to welcome Sanjay Keswani, who officially joined us in June as our Chief Medical Officer. He joins Neurocrine at an exciting time as we have initiated multiple Phase 3 programs within a single calendar year with both osavampator and NBI-’568, enrolling patients in registrational studies.

談到臨床管線，我們相信我們擁有業內最深、最多樣化的以神經科學為重點的管線之一。我謹歡迎 Sanjay Keswani，他於六月正式加入我們，擔任首席醫療官。他加入 Neurocrine 正值激動人心的時刻，因為我們在一年之內就已啟動了 osavampator 和 NBI-568 的多個 3 期項目，並招募患者參與註冊研究。

At our upcoming R&D Day on December 16, we look forward to sharing additional data from both programs as well as our perspective on the psychiatry portfolio and progress in our R&D transformation. On the pre-clinical front, our R&D engine led by Chief Scientific Officer Jude Onyia is advancing internally discovered biologics candidates towards the clinic, which further diversifies our mechanistic approach to address a broad range of diseases aligned with our expertise and strategic focus.

在我們即將於 12 月 16 日舉行的研發日上，我們期待分享這兩個項目的更多數據以及我們對精神病學組合和研發轉型進展的看法。在臨床前方面，由首席科學官 Jude Onyia 領導的研發引擎正在將內部發現的候選生物製劑推向臨床，這進一步使我們的機制方法多樣化，以根據我們的專業知識和策略重點解決廣泛的疾病。

Overall, I'm pleased with our performance in the first half of the year. Looking ahead, sustained revenue contribution from both INGREZZA and now CRENESSITY will enable us to further invest in advancing and expanding our pipeline, and importantly, helping more patients than ever before in solidifying Neurocrine's position as a leading neurology-focused enterprise. With that, I will turn the call over to Matt.

整體來說，我對我們上半年的表現感到滿意。展望未來，INGREZZA 和現在的 CRENESSITY 的持續收入貢獻將使我們能夠進一步投資於推進和擴大我們的產品線，更重要的是，幫助比以往更多的患者，鞏固 Neurocrine 作為領先的神經病學企業的地位。說完這些，我會把電話轉給馬特。

Thank you, Kyle, and good afternoon, everyone. Neurocrine's evolution into a multi-product growth company was underscored by $682 million in net product sales during the second quarter, representing 17% year over year growth. We expect the profile of both CRENESSITY and INGREZZA to drive meaningful revenue growth and generate significant cash flow over the coming years, positioning Neurocrine to become a leading CNS company.

謝謝你，凱爾，大家下午好。Neurocrine 已發展成為多產品成長型公司，第二季淨產品銷售額達 6.82 億美元，較去年同期成長 17%。我們預計，CRENESSITY 和 INGREZZA 的概況將在未來幾年推動有意義的收入成長並產生可觀的現金流，從而使 Neurocrine 成為領先的中樞神經系統公司。

CRENESSITY grew sequentially from $15 million in Q1 2025 to $53 million in Q2 2025, reflecting strong early adoption by CAH patients and clinicians eager for better treatment options. Although only six months into launch, we are quite encouraged by what we're seeing in terms of steady new patient starts, greater than 75% of all dispensed prescriptions being reimbursed, and overall positive anecdotal feedback on product performance. As Eric says, so far so great, and kudos to everyone involved in this launch.

CRENESSITY 從 2025 年第一季的 1,500 萬美元連續增長至 2025 年第二季的 5,300 萬美元，反映出 CAH 患者和渴望獲得更好治療選擇的臨床醫生的早期大力採用。儘管該產品上市僅六個月，但我們對所看到的情況感到非常鼓舞，新患者數量穩步增長，超過 75% 的處方得到報銷，而且產品性能總體上獲得了積極的反饋。正如 Eric 所說，到目前為止一切順利，向參與此次發布的每個人致敬。

Shifting to INGREZZA, we delivered $624 million in second quarter sales, including another record number of new patient starts, reflecting the fruits of the salesforce expansion our DTC campaign, and early positive signs from our investment and expanded access.

轉向 INGREZZA 後，我們在第二季度實現了 6.24 億美元的銷售額，其中包括創紀錄的新患者數量，這反映了 DTC 活動銷售隊伍擴張的成果，以及我們投資和擴大渠道的早期積極跡象。

Importantly, on both NRx and TRx front, we are seeing prescription market share gains in the first half of 2025. While we expect to gain volume share for the remainder of 2025, dollar share will be impacted in the near term due to contracting. These are intentional investments that position INGREZZA for continued volume and sales growth, as well as market share gains over the coming years.

重要的是，在 NRx 和 TRx 方面，我們都看到 2025 年上半年處方藥市佔率有所成長。雖然我們預計 2025 年剩餘時間內銷售份額將會增加，但由於收縮，美元份額在短期內將受到影響。這些有意的投資將使 INGREZZA 在未來幾年內保持銷量和銷售額的持續成長以及市場份額的擴大。

Given current performance and considering market access investments for the remainder of the year, we've refined the INGREZZA net sales guidance range to $2.5 billion to $2.55 billion which accounts for anticipated double-digit volume gains partially offset by higher near-term gross-to-net impact. Overall, INGREZZA was well positioned for continued growth heading into 2026.

鑑於目前的業績並考慮今年剩餘時間的市場准入投資，我們將 INGREZZA 淨銷售額預期範圍調整至 25 億美元至 25.5 億美元，這部分抵消了預期的兩位數銷量增長，但近期毛利對淨額的影響有所增加。總體而言，INGREZZA 已做好準備，在 2026 年繼續保持成長。

A few financial comments. Our capital allocation priorities remained intact: drive revenue growth, advance our R&D programs, enable business development, and return capital to shareholders. Our progress in the first half of 2025 reflect these priorities with a strong launch of CRENESSITY, continued INGREZZA growth, and the initiation of our two Phase 3 programs for osavampator in MDD and muscarinic schizophrenia trials.

一些財務評論。我們的資本配置重點保持不變：推動營收成長、推動研發計畫、促進業務發展以及向股東返還資本。我們在 2025 年上半年取得的進展反映了這些優先事項，強勢推出了 CRENESSITY，持續了 INGREZZA 的成長，並啟動了針對 MDD 和毒蕈鹼型精神分裂症試驗的兩項 3 期 osavampator 計畫。

We have increased SG&A GAAP and non-GAAP operating expense guidance by $25 million to support continued CRENESSITY and INGREZZA sales growth. And we expect SG&A leverage throughout the second half of 2025.

我們將銷售、一般及行政開支 (SG&A) 的 GAAP 和非 GAAP 營運費用指引增加了 2,500 萬美元，以支持 CRENESSITY 和 INGREZZA 銷售的持續成長。我們預計 2025 年下半年銷售、一般及行政費用 (SG&A) 槓桿率將持續上升。

With $1.8 billion in cash and a strong balance sheet, we're well positioned to support our commercial and clinical development strategies for continued growth. With that, I'll now hand the call over to Eric Benovich, our Chief Commercial Officer. Eric?

憑藉 18 億美元現金和強勁的資產負債表，我們完全有能力支持我們的商業和臨床發展策略，實現持續成長。現在，我將把電話交給我們的首席商務官 Eric Benovich。艾瑞克？

Thanks, Matt. Q2 was a quarter of continued strong execution of our INGREZZA growth strategy. Our strategic investments in the INGREZZA franchise over the past year are yielding tangible results. These investments, such as last year's salesforce expansion, enhanced marketing initiatives, and increased contracting for Medicare formulary coverage combined with strong efforts from our commercial and medical teams led to a record number of new patient starts and total prescriptions for the quarter. In fact, this was the second quarter in a row of all-time high new patient starts.

謝謝，馬特。第二季是我們持續強力執行 INGREZZA 成長策略的季度。我們過去一年對 INGREZZA 特許經營權的策略性投資正在產生實際的成果。這些投資，例如去年的銷售隊伍擴張、強化的營銷舉措、增加的醫療保險處方集承包合同，加上我們商業和醫療團隊的大力努力，使得本季度的新患者數量和處方總數創下了歷史新高。事實上，這是連續第二季新增患者數創下歷史新高。

Q2 sales of $624 million represented 15% sequential growth and year-over-year sales growth of 8%. In addition, we saw continued prescription VMAT2 market share gains in Q2. In Q2 and again in early Q3, as Matt noted, we contracted to further expand Medicare formulary coverage for INGREZZA.

第二季銷售額為 6.24 億美元，季增 15%，年增 8%。此外，我們看到第二季度處方 VMAT2 市場份額持續成長。正如 Matt 所指出的，在第二季度和第三季度初，我們簽訂了合同，進一步擴大 INGREZZA 的醫療保險處方集覆蓋範圍。

We now have formulary coverage for approximately 70% of Medicare beneficiary lives in the TD market. These incremental rebate agreements were mid-year adds to key formularies outside of the regular bid cycle. They substantially improve our coverage and will make it easier for patients and providers to start or reinitiating INGREZZA therapy going forward.

目前，我們的處方集涵蓋了 TD 市場中約 70% 的醫療保險受益人。這些增量回扣協議是在常規投標週期之外對主要處方集進行年中增加的。它們大大提高了我們的覆蓋範圍，並使患者和提供者能夠更輕鬆地開始或重新啟動 INGREZZA 治療。

The formulary adds in Q2 and Q3 represent approximately a 25% increase in coverage in just two quarters and embody the stellar work done by our market access team. We acknowledge that these rebate agreements encompass prescriptions for all current INGREZZA patients insured under those plans, not just the new incremental patients. So we saw an impact on our gross to net which somewhat offset our strong volume growth. However, we believe that over time, these Medicare formulary investments will allow us to grow our volume and share faster than we otherwise would.

第二季和第三季的處方集增加意味著在短短兩個季度內覆蓋率增加了約 25%，體現了我們的市場准入團隊所做的出色工作。我們承認這些回扣協議涵蓋了這些計劃下所有現有 INGREZZA 患者的處方，而不僅僅是新增加的患者。因此，我們的總收入與淨收入受到了影響，這在一定程度上抵消了我們強勁的銷售成長。然而，我們相信，隨著時間的推移，這些醫療保險處方集投資將使我們的數量和份額比以往更快地增長。

With less than half of the estimated 800,000 TD patients as yet diagnosed and approximately 13 more years of exclusivity, we believe these sales, marketing, and access investments position the INGREZZA franchise well for growth in the years to come.

在預計的 80 萬名 TD 患者中，目前確診的還不到一半，而且還有大約 13 年的獨家經營期，我們相信，這些銷售、行銷和准入投資將為 INGREZZA 特許經營在未來幾年的成長奠定良好的基礎。

Now, turning to CRENESSITY, the launch is off to a strong start with early results surpassing our internal expectations. In Q2, we received 664 new treatment forms, and over 1,000 have come in since we launched in late December. This was an important milestone for our franchise.

現在，談到 CRENESSITY，此次發布會開局強勁，早期結果超出了我們的內部預期。在第二季度，我們收到了 664 份新的治療表格，自 12 月底推出以來，我們已收到 1,000 多份。這對我們的特許經營來說是一個重要的里程碑。

Q2 net sales were $53 million, more than triple our Q1 sales. And over 75% of all dispensed prescriptions in the quarter were reimbursed. Clearly, we're building strong momentum with this launch. To date, we've seen widespread adoption across both pediatric and adult patients, with a slight trend towards pediatrics after two full quarters on the market.

第二季淨銷售額為 5,300 萬美元，是第一季銷售額的三倍多。本季度超過 75% 的處方都得到了報銷。顯然，我們透過這次發布積累了強勁的勢頭。到目前為止，我們已經看到該技術在兒科和成人患者中廣泛應用，並且在上市整整兩個季度後，兒科患者略有採用。

Furthermore, we've seen prescriptions written by a range of CAH healthcare providers, including those practicing at multidisciplinary centers of excellence, pediatric endocrinologists, and community-based adult endocrinologists. Given the early stage of the launch, most individual prescribers have only initiated treatment for one or two patients so far, which is to be expected.

此外，我們還看到了由一系列 CAH 醫療保健提供者開出的處方，包括在多學科卓越中心執業的醫生、兒科內分泌學家和社區成人內分泌學家。鑑於該療法尚處於早期階段，大多數個別處方者迄今僅對一至兩名患者開始治療，這是可以預料的。

Now, let me share a little color on the launch. Earlier in July, our commercial and medical teams had a strong showing at the Endocrine Society Annual Meeting in San Francisco, where we presented 16 posters, including long-term CRENESSITY efficacy and tolerability data, and weight-related outcomes. Attendance at our commercial and medical booths, as well as our sponsored symposia, was very good. Feedback from endocrinologists who have already treated patients with CRENESSITY was quite positive, and the interest level was high amongst those who haven't yet had a chance to prescribe.

現在，讓我分享一些有關此次發布會的一些資訊。7 月初，我們的商業和醫療團隊在舊金山舉行的內分泌學會年會上表現出色，展示了 16 張海報，包括長期 CRENESSITY 功效和耐受性數據以及體重相關結果。我們的商業和醫療攤位以及我們贊助的研討會的出席率非常高。已經使用 CRENESSITY 治療過患者的內分泌學家的回饋非常積極，而那些尚未有機會開處方的內分泌學家的興趣程度也很高。

With two full quarters complete, CRENESSITY's performance continues to trend very positively. We have all the right ingredients here for a future blockbuster: high unmet need, strong efficacy and safety data, a broad and favorable label, and highly dedicated teams who put CAH patients' needs first. Once again, I'd like to thank our commercial and medical teams for driving strong results for both INGREZZA and CRENESSITY in Q2. And with that, for the first time ever, I'll hand the call over to my new colleague, Dr. Sanjay Keswani, our Chief Medical Officer.

兩個完整季度已經過去，CRENESSITY 的業績持續呈現非常正面的趨勢。我們擁有未來重磅藥物的所有正確要素：大量未滿足的需求、強大的療效和安全性數據、廣泛而有利的標籤，以及將 CAH 患者的需求放在首位的高度敬業的團隊。我再次感謝我們的商業和醫療團隊在第二季度為 INGREZZA 和 CRENESSITY 帶來了強勁的業績。接下來，我將首次把發言權交給我的新同事、我們的首席醫療官桑傑·凱斯瓦尼博士。

Thanks, Eric, and good afternoon, everyone. Before I begin, I want to express how enthusiastic I am to join, Kyle, the Neurocrine team as Chief Medical Officer. I'd also like to acknowledge my predecessor, Dr. Eiry Roberts, for her remarkable leadership and the significant clinical advancements accomplished during her tenure. I'm grateful that Eiry will continue to support us as a strategic advisor through the end of next year.

謝謝，埃里克，大家下午好。在我開始之前，我想表達我加入 Neurocrine 團隊擔任首席醫療官的熱情，Kyle。我還要感謝我的前任艾里·羅伯茨博士，感謝她卓越的領導能力以及在任職期間取得的重大臨床進展。我很感激 Eiry 將在明年年底之前繼續擔任我們的策略顧問，為我們提供支援。

Now, on to the clinical update. The registrational studies for both osavampator in major depressive disorder and NBI-’568 in schizophrenia are progressing well. Indeed, we have just screened the first patient in our second Phase 3 study in schizophrenia for ’568. Hence, all the Phase 3 studies as well as the open-label studies for ’568 and osavampator are up and running. And we anticipate topline data readouts for osavampator in 2027 and a bit later for ’568 in the 2027-2028 time frame.

現在，我們來了解一下臨床更新情況。osavampator 在治療重度憂鬱症的註冊研究和 NBI-568 在治療精神分裂症方面的註冊研究進展順利。事實上，我們剛剛對第二項 3 期精神分裂症研究的第一位患者進行了 568 篩選。因此，568 和 osavampator 的所有 3 期研究以及開放標籤研究均已啟動並運行。我們預期 osavampator 的頂線資料將於 2027 年公佈，而 ââ568 的頂線資料則將於 2027-2028 年期間公佈。

Regarding data readouts this year, we disclosed in May that for the adjunctive treatment of schizophrenia, valbenazine did not meet the primary endpoint of improvement in the Positive and Negative Syndrome Scale, or PANSS. Recall, this study was designed as a learning opportunity for our next-generation VMAT2 follow-on programs and has indeed provided valuable insights.

關於今年的數據讀數，我們在五月披露，作為精神分裂症的輔助治療，伐貝那嗪沒有達到陽性和陰性症狀量表（PANSS）改善的主要終點。回想一下，這項研究旨在為我們的下一代 VMAT2 後續計劃提供學習機會，並且確實提供了寶貴的見解。

Notably, we observed numerical separation and improvements in the valbenazine arm compared to placebo, as well as statistically significant improvement in positive symptoms. We look forward to sharing the full study results at an upcoming scientific meeting.

值得注意的是，我們觀察到與安慰劑組相比，伐貝那嗪組在數值上有所分離和改善，且陽性症狀也有統計學上顯著的改善。我們期待在即將舉行的科學會議上分享完整的研究結果。

Continuing with valbenazine, topline results from our Phase 3 study for the treatment of dyskinetic cerebral palsy will read out in Q4 of this year. In addition, the Phase 2 proof-of-concept and dose-finding study for NBI-'770, our NMDA NR2B negative allosteric modulator, will also read out topline data in Q4. With a positive readout, these data could pave the way for a confirmatory Phase 2 study or the initiation of a Phase 3 trial.

繼續進行伐貝那嗪的研究，我們針對運動障礙性腦性麻痺治療的 3 期研究的主要結果將於今年第四季公佈。此外，我們的 NMDA NR2B 負變構調節劑 NBI-'770 的 2 期概念驗證和劑量探索研究也將在第四季度讀出頂線資料。如果結果呈陽性，這些數據可以為第 2 階段驗證性研究或第 3 階段試驗的啟動鋪平道路。

Turning to our new programs, last month we announced the initiation of the Phase 1 study for NBIP-’1435, a long-acting corticotropin-releasing factor 1 receptor antagonist administered subcutaneously for the potential treatment of congenital adrenal hyperplasia. This program marks the first investigational peptide from our internal pipeline to advance into the clinic. It's also the first of what we anticipate to be many biological compounds advancing from Chief Scientific Officer Jude Onyia's research division.

談到我們的新項目，上個月我們宣布啟動 NBIP-1435 的 1 期研究，NBIP-1435 是一種皮下注射的長效促皮質素釋放因子 1 受體拮抗劑，用於治療先天性腎上腺增生。此計畫標誌著我們內部研發管線中首個進入臨床階段的試驗勝肽。這也是我們期待的首席科學官 Jude Onyia 研究部門所研發的眾多生物化合物中的第一個。

Regarding our early-stage muscarinic programs, we remain on track to initiate the Phase 2 study of NBI-'570, our dual M1/M4 selective agonist for the treatment of schizophrenia. We also expect to report Phase 1 results later this year for both NBI-'567, our M1-preferring dual agonist, and NBI-'569, our M4-preferring dual agonist. I look forward to engaging with many of you over the coming months ahead in advance of our R&D Day at Neurocrine's campus in San Diego on December 16. With that, I'll hand the call back to Kyle.

關於我們的早期毒蕈鹼項目，我們仍將按計劃啟動 NBI-'570（用於治療精神分裂症的雙重 M1/M4 選擇性激動劑）的 2 期研究。我們也預計今年稍後報告 NBI-'567（我們的 M1 優先雙重激動劑）和 NBI-'569（我們的 M4 優先雙重激動劑）的第一階段結果。我期待在未來幾個月與你們中的許多人進行交流，以便參加 12 月 16 日在聖地亞哥 Neurocrine 園區舉行的研發日。說完這些，我就把電話轉回給凱爾。

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

謝謝，桑傑。我想我們現在可以回答問題了。

(Operator Instructions) Tazeen Ahmad, Bank of America.

（操作員指示）美國銀行 Tazeen Ahmad。

Hi guys, good afternoon, thanks for taking my question. So mine, I think, is going to be for Matt. Matt, we know that you're super detail-oriented. But taking that into account, you're narrowing the top end of guidance by $50 million. And we've still got half of the year left.

大家好，下午好，感謝您回答我的問題。所以我認為我的禮物是送給馬特的。馬特，我們知道你非常注重細節。但考慮到這一點，你將指導金額上限縮小了 5000 萬美元。我們還有半年的時間。

And, you know, I fully appreciate the comments that you made about having mid-year ads and improving access on Medicare, but I guess how are you triangulating that level of certainty? And is that number potentially up for future adjustment as the year progresses? Thanks.

而且，您知道，我完全感謝您關於發布年中廣告和改善醫療保險覆蓋面的評論，但我想您如何對這種確定性進行三角測量？隨著時間的推移，這個數字是否有可能在未來進行調整？謝謝。

Yeah. Thanks, Tazeen. It really comes down to the contracting and where net price was coming into the year. As you mentioned, I am detail-oriented, and so I never like to have anything changed throughout the year. But that's not the case of our business. It's very dynamic.

是的。謝謝，Tazeen。這實際上取決於合約以及當年的淨價。正如你所說，我注重細節，所以我不喜歡一年到頭有任何改變。但我們的生意並非如此。它非常有活力。

And on the pricing front, we had assumed a flat pricing coming into the year based upon the contracting in place. But throughout this year we've been able to pull forward, actually, some major programs in contracting from 2026 into 2025.

在定價方面，我們根據現有的合約假設今年的定價將保持固定。但今年我們實際上已經能夠將一些主要項目的承包時間從 2026 年提前到 2025 年。

So from a pricing perspective, we went from flattish pricing expectations to, call it, negative 5% price decline for the year. And so I think that should help triangulate where the guidance range is at.

因此，從定價角度來看，我們從持平的定價預期轉變為全年價格下降 5%。所以我認為這應該有助於確定指導範圍的位置。

From a volume perspective, kudos to the team, record numbers of TRx, record numbers of new patients, double-digit volume growth. So on the volume side, everything is going well for us as well as in the marketplace. This adjustment down on the top end really comes back to a change in assumption around pricing.

從數量角度來看，值得稱讚的是團隊，TRx數量創歷史新高，新患者數量創歷史新高，數量實現了兩位數增長。因此，從銷售量來看，我們和市場一切進展順利。高端的這種下調其實源自於對定價假設的改變。

Phil Nadeau, TD Cowen.

菲爾·納多 (Phil Nadeau)，TD Cowen。

Good morning or good afternoon. Thanks for taking our question. Congrats on the CRENESSITY number. It does seem to be launching much more quickly than most of us had anticipated. Can you talk about the dynamics you're encountering at the clinics? In particular, were there any boluses of patients added to CRENESSITY during the quarter?

早安或下午好。感謝您回答我們的問題。恭喜您獲得 CRENESSITY 號碼。它的推出速度似乎比我們大多數人預期的要快得多。您能談談您在診所遇到的情況嗎？具體來說，本季度是否有任何患者被添加到 CRENESSITY？

Any reason why we shouldn't extrapolate the growth we saw in Q2 to future quarters, or any other dynamics that we should consider as we try to digest the big number you just put up and what that portends for future quarters? Thanks.

為什麼我們不應該將第二季的成長推斷到未來幾季？或者，當我們試圖消化您剛剛提出的大數字以及這對未來幾季意味著什麼時，我們應該考慮其他什麼動態？謝謝。

Yeah, hi Phil. So, I'll comment, and maybe, Eiry has some additional commentary here. But before the launch and after Q1, we had sort of guided towards what we call the measured launch. And the reasons for that were primarily around patient flow through the practices.

是的，你好，菲爾。因此，我會發表評論，也許，Eiry 在這裡還有一些補充評論。但在發布之前和第一季之後，我們已經朝著所謂的「有計劃的發布」的方向發展。原因主要在於患者在診所內的流動情況。

We know that adult patients usually only see their endocrinologist once, maybe twice a year; pediatric patients, two or three times a year. And endocrinologists had indicated to us that they intended to offer CRENESSITY treatment as patients flow through.

我們知道成年患者通常每年只看內分泌科一次或兩次；兒科患者每年看內分泌科兩到三次。內分泌學家向我們表示，他們打算在患者來訪時提供 CRENESSITY 治療。

Those dynamics haven't really changed. We're still seeing that patients are being initiated subsequent to an in-person visit. That being said, we have seen strong adoption. Obviously, we feel really good about the pace of patient starts, and it's building over time. Certainly, I think it's a function of our ability to reach the endocrinologist and to get the word out within the patient and family communities.

這些動態其實並沒有改變。我們仍然看到患者在親自就診後開始接受治療。話雖如此，我們已經看到了強勁的採用。顯然，我們對患者開始治療的速度感到非常滿意，而且這種速度正在隨著時間的推移而加快。當然，我認為這取決於我們聯繫內分泌科醫生並在患者和家庭社區中傳播訊息的能力。

So, kind of getting back to this concept of a bolus, no, it's not really a bolus or patients that were necessarily waiting for CRENESSITY, because for the most part, people weren't aware of it prior to its approval. But we have seen what I would describe as very steady and consistent adoption, and certainly, we view the activity that we had at Endo as sort of another booster for us in terms of being able to accelerate that awareness within the endocrinology community.

所以，回到這個推注的概念，不，它實際上不是一個推注，患者也不一定在等待 CRENESSITY，因為大多數情況下，人們在它獲得批准之前並不知道它。但我們已經看到了我所描述的非常穩定和一致的採用，當然，我們認為我們在 Endo 開展的活動對我們來說是另一種助推器，能夠加速內分泌學界對此的認識。

Hi Phil, thanks. The only thing I'd add there is, I mean, I do think we have a lot of interest and excitement out there in the community, and we certainly felt that during our participation in ENDO. And that comes from both the clinicians and also the patients.

嗨，菲爾，謝謝。我唯一想補充的是，我的意思是，我確實認為我們在社區中有很多興趣和熱情，我們在參與 ENDO 期間確實感受到了這一點。這既來自臨床醫生，也來自病人。

We heard from several of the clinicians that we work with on the medical side that they were receiving a lot of questions from patients and requests from patients to get in and get the opportunity to talk about CRENESSITY.

我們從幾位與我們在醫療方面合作的臨床醫生那裡聽說，他們收到了很多來自患者的問題，以及患者的請求，希望有機會談論 CRENESSITY。

Certainly, the other place you'd think of a bolus is if there was one coming from the clinical trial environment. And as you know, we signaled that we were shutting down the adult open-label trial, and those patients are steadily moving on to commercial CRENESSITY. So it isn't a bolus effect there either.

當然，您想到的另一個推注的地方是來自臨床試驗環境的推注。如您所知，我們表示我們將關閉成人開放標籤試驗，並且那些患者將穩步轉向商業化的 CRENESSITY。所以這也不是推注效應。

And obviously, we still have our pediatric open-label extension trial going, which is going to provide us with longer-term clinical data that we think will be very important.

顯然，我們仍在進行兒科開放標籤擴展試驗，這將為我們提供我們認為非常重要的長期臨床數據。

Paul Matteis, Stifel.

保羅·馬泰斯（Paul Matteis），Stifel。

Thanks for taking my question. I was wondering if you can share any data or metrics or at least qualitative color on how concentrated prescribing has been at this point. If we look at some other rare disease launches that have had a great start, but maybe tapered off after a bit, it feels like there can be this sort of COE academic dynamic, and then the patient acquisition effort increases over time as you have to go to the community.

感謝您回答我的問題。我想知道您是否可以分享任何數據或指標，或至少是定性信息，以了解目前的處方集中程度。如果我們看看其他一些罕見疾病計畫的啟動，它們一開始表現得很好，但可能在一段時間後逐漸減弱，感覺可以存在這種 COE 學術動態，然後隨著時間的推移，隨著你必須走向社區，患者獲取工作就會增加。

So how do you think CAH stacks up with these sort of treatment dynamics and what you're seeing with CRENESSITY? Thank you.

那麼您認為 CAH 與此類治療動態以及您在 CRENESSITY 中看到的情況相比如何？謝謝。

Yeah, Paul. So, certainly we're very excited about the adoption that we're seeing prior to the launch. And subsequently, our estimate has been that, if you think about sort of three segments of endocrinology prescribers, we've got our centers of excellence that are accredited, and then there are others that are not accredited by the CARES Foundation.

是的，保羅。因此，我們對產品發布前所看到的採用情況感到非常興奮。隨後，我們的估計是，如果你考慮內分泌科處方者的三個部分，我們有獲得認證的卓越中心，還有一些沒有獲得 CARES 基金會認證的卓越中心。

Overall, we estimate that around 15% or so of the total CAH patient population flows through a small number of those centers, let's call it 20 or less. And then, an important segment is also the pediatric endocrinologist, there's a little over 1,000 of them out there. They care for all these pediatric patients and even some of the young adults. And then, there's the community endocrinologists. And that's where, as we say, the tail gets long.

總體而言，我們估計 CAH 患者總數的約 15% 流經少數幾個這樣的中心，我們假設是 20 個或更少。然後，兒科內分泌科醫生也是一個重要組成部分，大約有 1,000 多名。他們照顧所有這些兒科患者，甚至一些年輕人。然後，還有社區內分泌學家。正如我們所說，這就是尾巴變長的地方。

Ultimately though, this isn't a super concentrated patient population. Somewhere north of 20,000, we estimate in the US. And most of the adult community endocrinologists, if they have CAH in their practice, they have one or two patients.

但從根本上來說，這並不是一個高度集中的患者群。我們估計，美國的數量大約在 20,000 左右。大多數成人社區內分泌科醫生，如果他們在實踐中患有 CAH，他們就會有一到兩名患者。

And so in my prepared remarks, I commented that most of the prescribers so far have written for one or two patients. And in some instances, that's all they have. But certainly we see a lot of HCPs that have yet to prescribe. And in those centers of excellence, there's still a lot of room for growth in terms of adoption.

因此，在我準備好的演講中，我評論說，到目前為止，大多數開處方的人都是為一個或兩個病人開的。在某些情況下，這就是他們所擁有的一切。但我們確實看到很多醫療保健人員尚未開處方。在這些卓越中心，採用方面仍有很大的成長空間。

So it's still early days yet. We're two quarters in. We're pleased with the trajectory of the launch. But for the most part, this isn't a super concentrated patient population.

所以現在還為時過早。我們已經進行了兩個季度。我們對發射的軌跡感到滿意。但大多數情況下，這並不是一個高度集中的患者群體。

Hi Paul. The only thing I'd add there is that, I think, we are hearing that given the breadth of the label and the efficacy and tolerability data that was generated for CRENESSITY, that the ease of starting the therapy is helping -- ensure that it isn't something that is requiring that center of excellence presence in order to be able to get patients onto the medication.

你好，保羅。我唯一想補充的是，我認為，我們聽說，鑑於標籤的廣度以及為 CRENESSITY 生成的功效和耐受性數據，開始治療的便利性有助於——確保不需要卓越中心的存在就能讓患者服用藥物。

This is an exciting launch, so the last add here from the team. When you look at how steady the new patient additions were throughout the quarter, I mean, it was very consistent within a pretty tight range week by week. So I think if we would have had some inflection or some bolus effect, I don't think you'd see the steadiness in terms of overall adoption and new scripts written each week.

這是一次令人興奮的發布，也是團隊的最後一次補充。當您觀察整個季度新增患者數量有多穩定時，您會發現，每週新增患者數量都在一個相當狹窄的範圍內保持穩定。因此，我認為，如果我們有一些變化或一些推注效應，你就不會看到整體採用率和每週編寫的新腳本的穩定性。

So kudos to the team for finding these patients and getting them help, and then also for the reimbursement team to be able to have above 75% of scripts reimbursed at this point, just quite an accomplishment.

因此，我們要向找到這些患者並給予幫助的團隊表示祝賀，同時報銷團隊目前能夠報銷 75% 以上的處方費用，這是一項相當大的成就。

Cory Kasimov, Evercore.

科里·卡西莫夫（Cory Kasimov），Evercore。

Hey, good afternoon, guys. Thanks for taking the question. Wanted to follow up on Eiry's earlier comment on the adult OLE program and patients rolling from that over to commercial product. Are you able to provide any more granularity there in terms of percentage of patients that have moved over, and whether you would expect the rest to follow suit? Are there any nuances in this process that would perhaps prevent them from doing so? Thank you.

嘿，大家下午好。感謝您回答這個問題。想要跟進 Eiry 先前關於成人 OLE 計劃以及患者從該計劃轉向商業產品的評論。您能否提供更多有關已轉移患者百分比的詳細信息，以及您是否希望其餘患者也能效仿？這個過程中是否存在一些細微差別，可能會阻止他們這樣做？謝謝。

Hi Corey. So we're talking about less than 40 patients here, and you're going to see some of those. We saw some fall into Q2 and some fall into Q3. So in the context of over 600 patient starts in the quarter, pretty de minimis in terms of the overall landscape of what we're seeing with CRENESSITY.

你好，科里。所以我們在這裡談論的是不到 40 名患者，你會看到其中一些。我們看到有些進入第二季度，有些進入第三季度。因此，在本季有超過 600 名患者開始接受治療的情況下，就我們所看到的 CRENESSITY 的整體情況而言，這相當少見。

Jay Olson, Oppenheimer.

傑伊·奧爾森，奧本海默。

Congrats on the Crenessity launch success, and thank you for providing this update. I wanted to thank Eiry for her substantial contributions and wish her all the best. And I also wanted to welcome Sanjay, so congratulations on joining the team.

恭喜 Crenessity 發布成功，並感謝您提供此更新。我想感謝 Eiry 的巨大貢獻並祝她一切順利。我也想歡迎桑傑，恭喜你加入團隊。

And could you please share with us some of the key findings that you learned from your due diligence that attracted you to Neurocrine? Thank you.

您能否與我們分享您在盡職調查中了解到的一些吸引您加入 Neurocrine 的關鍵發現？謝謝。

Nice to meet you, Jay. Yeah, I'm super excited to join Kyle and the Neurocrine team. And yes, I'd also like to acknowledge Eiry, who's sitting just beside me for her terrific leadership.

很高興認識你，傑伊。是的，我非常高興加入 Kyle 和 Neurocrine 團隊。是的，我還要感謝坐在我旁邊的 Eiry，她展現了卓越的領導能力。

In terms of some of the reasons I joined, I thought the company was really the transformational stage evolving from primarily a small molecule to product company to potentially multiple modality company, targeting multiple therapeutics with multiple products. So the potential here positively impact the lives of many patients and their families who are suffering with unmet need is a major source of motivation for me.

就我加入的一些原因而言，我認為該公司實際上正處於轉型階段，從主要的小分子產品公司發展成為潛在的多模式公司，以多種產品針對多種療法。因此，這裡的潛力對許多患有未滿足需求的患者及其家人的生活產生積極影響，這是我的主要動力來源。

With respect to the portfolio, my perspective is that the late-phase psychiatry portfolio has a high probability of success because they are essentially validated targets. And I'm also really excited by our large early phase portfolio, which largely comprises large molecules, such as bispecifics, antibody-drug conjugates and petite with many of these programs having transformational potential.

關於投資組合，我的觀點是後期精神病學投資組合具有很高的成功機率，因為它們本質上是經過驗證的目標。我對我們龐大的早期產品組合也感到非常興奮，這些產品主要包括大分子，例如雙特異性抗體、抗體藥物偶聯物和小分子，其中許多項目都具有轉化潛力。

And as Kyle mentioned, we will discuss some of this at our R&D Day later this year. So I think that Neurocrine has walked the talk with respect to substantial R&D investment. So thank you for the question.

正如 Kyle 所提到的，我們將在今年稍後的研發日上討論其中的一些內容。因此我認為 Neurocrine 在大量研發投資方面已經說到做到。謝謝你的提問。

Brian Abrahams, RBC Capital Markets.

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

Hey, good afternoon. Thanks for taking my question. I'm curious if you could talk about what steered your decision to contract INGREZZA mid-year? How long these contracts -- we should think about these contracts generally being in place for? And should we not expect now additional contracting shortly after the new IRA prices established for your competitor? Thanks.

嘿，下午好。感謝您回答我的問題。我很好奇，您能否談談是什麼促使您決定在年中與 INGREZZA 簽約？這些合約－我們應該考慮這些合約通常有效期是多長？我們不應該期待在新的 IRA 價格為競爭對手製定後不久簽訂額外的合約嗎？謝謝。

Hi, Brian. This is Kyle. You probably heard from me when I stepped into the role a lot more conversation about looking at maximizing access for patients. I think it's something that is important to me and the company, it's always been a north star for us to do that for patients. We think that's in their best interest in terms of offering options for their care. I also think it provides a great deal of flexibility for us moving into the new era of IRA that starts next year with the first round of 10 that go through their price negotiation.

你好，布萊恩。這是凱爾。當我上任這個職位時，您可能聽到更多關於如何最大限度地為患者提供就醫機會的討論。我認為這對我和公司都很重要，為患者做到這一點一直是我們的指導方針。我們認為，從提供護理選擇的角度來看，這符合他們的最佳利益。我還認為，它為我們進入 IRA 新時代提供了巨大的靈活性，新時代將於明年開始，首輪 10 個 IRA 將進行價格談判。

So as you know, with the contracting process, this starts well in advance of the year that you're looking to actually observe your new price, if you will. And our contracting efforts that we outlined here were actually started -- initiated with the mindset that we began in 2026.

因此，如您所知，簽訂合約的過程早在您實際觀察新價格的年份之前就開始了，如果您願意的話。我們在此概述的承包工作實際上是從 2026 年開始的。

And obviously, when you start the year in these discussions, you don't know where they're going to go. But we got them to a good place for '26 and the opportunity to accelerate or pull them forward into 2025. So you saw some of the efforts there result into an advantage for us starting in Q2 and then another one that has played out for the start here in Q3.

顯然，當你在年初進行這些討論時，你不知道他們會走向何方。但我們讓他們為 26 年取得了良好的成績，並有機會加速或推動他們進入 2025 年。因此，您可以看到，從 Q2 開始，我們的一些努力為我們帶來了優勢，而從 Q3 開始，我們的另一項努力也發揮了優勢。

So that's where we are today on this. I think that's part and parcel of where we landed on narrowing the band of our guidance to $2.5 billion to $2.55 billion. But I do want to go back to a point that Matt started earlier in the call. What we saw here in Q2 was a second quarter of new record new prescriptions as well as total prescriptions, and that led to a market share increase in new-to-brand prescriptions as well as total prescriptions.

這就是我們今天要討論的這個問題。我認為這是我們將指導範圍縮小至 25 億美元至 25.5 億美元的一部分。但我確實想回到馬特早些時候在電話中提出的觀點。我們在第二季度看到的是新處方和總處方量創下新高，這導致新品牌處方和總處方量的市場份額增加。

That doesn't happen by chance 8 years into commercialization. It really is a function of sound business fundamentals and this is across our sales force expansion that started later or late last year through the marketing initiatives that we outlined for this year and the market access advantages that we now have.

商業化八年後的這項結果並非偶然。這確實是良好業務基本面的體現，並且貫穿我們去年晚些時候或年底開始的銷售隊伍擴張，透過我們今年制定的營銷計劃以及我們目前擁有的市場准入優勢。

So you pair those together with very strong demand in the patient segment within TD, and we're seeing the uptick in the volume that we think is very important for our business, this year, in terms of new patient starts but even more important in 2026. We're going to start off on day one on a good foot and really have a strong year. So I think that gives you a nice feel for our contracting process and thoughts here for this year in '26.

因此，將這些與 TD 內部患者領域的強勁需求結合起來，我們看到了數量的上升，我們認為這對我們今年的業務非常重要，就新患者開始數量而言，但在 2026 年則更為重要。我們將從第一天開始就有一個良好的開端，並迎來強勁的一年。所以我認為這能讓您很好地了解我們 26 年的簽約流程和想法。

Yeah. I think, Brian, you were also wanting some clarification around any additional contracting that we would expect to take place and just do want to build on what Kyle said in that, we believe this sets us up really well for 2026.

是的。布萊恩，我想你也希望對我們預計將簽訂的任何額外合約得到一些澄清，並且只是想在凱爾所說的基礎上，我們相信這為 2026 年做好了充分的準備。

So sitting here right now, do not expect or believe there's going to be any major contracts signed that would aggregate pricing further from how we're exiting 2025. So sitting here right now, we would expect very similar pricing into 2026 based upon the amount of coverage that we have. But we'll, of course, update everybody if that were to change.

因此，現在坐在這裡，不要期望或相信會簽署任何重大合同，這些合同將使我們在 2025 年之後的定價進一步趨於一致。因此，根據我們現在的覆蓋範圍，我們預計到 2026 年的價格將非常相似。但如果情況有變，我們當然會及時通知大家。

Anupam Rama, JPMorgan

摩根大通 Anupam Rama

Hey guys. Thanks so much for taking the question and congrats on the CRENESSITY launch. Quickly on the valbenazine schizophrenia update. What are you learning from that study on VMAT2 mechanism in schizophrenia, target population considerations or trial design considerations that you look to the next-gen VMAT2? Thanks so much.

嘿，大家好。非常感謝您回答這個問題，並祝賀 CRENESSITY 的推出。快速了解關於 valbenazine 精神分裂症的最新情況。您從精神分裂症中 VMAT2 機制的研究中了解到了什麼？您對下一代 VMAT2 有何展望？目標族群考慮因素或試驗設計考量是什麼？非常感謝。

Yeah. I think it's, as you mentioned, important to understand that, that study in ATS was a learning opportunity for us, specifically for our VMAT2 follow-on programs. So what we saw was essentially some positive efficacy signal in the positive scale within the PANSS score.

是的。我認為，正如您所說，重要的是要理解，在 ATS 的學習對我們來說是一個學習機會，特別是對於我們的 VMAT2 後續課程而言。因此，我們看到的基本上是 PANSS 評分中正向尺度上的一些正面效能訊號。

And so I think that will be very helpful in terms of understanding the target patient population for the other programs that are following valbenazine. But I don't know, Eiry, if you want to mention some more of it.

因此，我認為這對於了解繼伐貝那嗪之後的其他項目的目標患者群體非常有幫助。但我不知道，Eiry，你是否想再提一些。

No, happy to. I think the first thing to say was it was a well-designed, well-controlled large study. So actually, I think we were very pleased with the level of the data and information we were able to get out of the study. So that was a good thing.

不，很高興。我認為首先要說的是，這是一項設計良好、控制良好的大型研究。所以實際上，我認為我們對從研究中獲得的數據和資訊水平感到非常滿意。所以這是一件好事。

Secondly, I think it's really helpful that it confirmed in a larger population of 400 patients the safety and tolerability profile that we knew was there for valbenazine, but it's good to see it in these more acutely and well individuals.

其次，我認為它在 400 名患者中證實了我們所知的 Valbenazine 的安全性和耐受性特徵，這非常有幫助，但很高興在這些更敏銳、更健康的個體中看到它。

We obviously, beyond the PANSS positive score on the PANSS total score, we're able to look at a whole series of the sub scores and additional quality of life functional measures and other things of that sort. And what I'll say is that there were some interesting signals in there across the sub scores that we will intend to publish on in due course over the next few months. And we'll obviously use that knowledge as well to inform the next generation of VMAT2 inhibitors in terms of choice of patient population, indications and other elements.

顯然，除了 PANSS 總分中的 PANSS 正分數之外，我們還可以查看一系列子分數和額外的生活品質功能指標以及其他類似的東西。我想說的是，各個子分數中都存在一些有趣的訊號，我們打算在未來幾個月內適時發布這些訊號。顯然，我們也會利用這些知識來指導下一代 VMAT2 抑制劑在患者族群、適應症和其他因素的選擇方面。

Brian Skorney, Baird.

布萊恩·斯科尼，貝爾德。

Hey, good afternoon, everyone, and, thank you for taking the question. Also in CRENESSITY, congrats on another strong quarter. So hoping you could maybe give us a little more detail on the derivation of that figure.

嘿，大家下午好，謝謝你回答這個問題。同樣，祝賀 CRENESSITY 又一個強勁的季度。所以希望您能給我們更多關於該數字的推導細節。

Is there any inventory dynamic in this quarter? And can you disclose the number of build prescriptions represented here? It just seems hard to calculate more than like 2,000 TRx in the quarter given the patient start forms and reimbursement numbers you gave us, which puts the net TRx somewhere in the high 20,000 range.

本季庫存有動態嗎？您能透露一下這裡代表的建造處方的數量嗎？根據您提供給我們的患者開始表格和報銷數字，似乎很難計算出本季度超過 2,000 TRx，這使得淨 TRx 處於 20,000 的高位範圍內。

I guess, are we in the right ballpark with those numbers? And how do you think about pricing going forward, both on sort of gross to net and mix of adult and pediatrics?

我想，這些數字的估計準確嗎？您如何看待未來的定價，包括總價與淨價以及成人和兒科的混合？

Yeah, Brian. On the inventory front, because I've seen some notes on this. But on the inventory front, what we had in the quarter was a build of around $5 million. So that's just reflective of growth in the channel as the scripts continue to grow.

是的，布萊恩。在庫存方面，因為我已經看到了一些關於這方面的說明。但在庫存方面，本季我們增加了約 500 萬美元。所以這只是反映了隨著劇本的不斷增長，管道也不斷增長。

As we've said before, very consistent demand throughout the quarter, very good job from our pharmacy getting patients ultimately on therapy in gross to net so far has largely been on the heels of co-pay assistance as well as some distribution fees and costs. And like we've said, haven't been at a place of contracting yet. So good job to the team so far.

正如我們之前所說，整個季度的需求非常穩定，我們的藥房做得非常好，讓患者最終接受治療，到目前為止，從總治療到淨治療，很大程度上是依靠共同支付援助以及一些分銷費用和成本。正如我們所說的那樣，我們還沒有到達簽約的階段。到目前為止，團隊表現非常出色。

Yatin Suneja with Guggenheim Partners.

亞汀蘇內賈 (Yatin Suneja) 與古根漢合夥人事務所合作。

Hey, guys, thank you for taking my question. I have a question regarding the IRA implication. If you can just maybe talk about what -- how do you envision the access to shake out, I mean what would be the end goal?

嘿，夥計們，謝謝你們回答我的問題。我有一個關於 IRA 含義的問題。如果您可以談論一下——您設想如何擺脫困境，我的意思是最終目標是什麼？

Will you seek access at parity once we know the negotiated prices? Just curious if you can outline that dynamic for us the best you can and also your expectations on how whether one drug will be mandated versus the other? Thank you so much.

一旦我們知道了協商價格，你們會尋求以同等價格進入嗎？我只是好奇您是否可以盡可能詳細地為我們概述一下這種動態，以及您對一種藥物與另一種藥物是否會被強制執行的預期？太感謝了。

Yes. This is Kyle. I'll start a response here, and I'll ask Eric to fill in any holes in my answer here. I think for IRA, I mean there's a couple of pieces here that I would point you to. There's our own IRA moment in 2029.

是的。這是凱爾。我將在這裡開始回复，並請 Eric 填補我答案中的任何漏洞。我認為對於 IRA 來說，這裡有幾點我想向你指出。2029 年將迎來我們自己的 IRA 時刻。

That's when our negotiated price is enacted and then there's our competitor in this space with deuterated tetrabenazine in 2027. And if you want to just speak to the near term, event with our competitor. I think we start with -- we acknowledge we don't have all the answers, what's going to happen during an IRA. I don't think anyone does.

那時我們的協商價格就會實施，而 2027 年我們的競爭對手將出現在該領域，推出氘代丁苯那嗪。如果您只想談論近期與我們的競爭對手的事件。我認為我們首先要承認的是，我們還沒有完全弄清楚 IRA 期間會發生什麼。我認為沒有人會這麼做。

So I think we all acknowledge that piece. It's a good place to land on. In 2025, we're going to see what happens with other brands in the same categories where medicines are negotiated. So I think we'll have some learnings there.

所以我認為我們都承認這一點。這是個很好的著陸地點。到 2025 年，我們將看到在藥品談判中同一類別的其他品牌會發生什麼情況。所以我認為我們會從中學到一些東西。

And then the third piece I'd point out is, our goal here is to maximize the number of patients on INGREZZA, that's part of our maximizing our access strategy here. And I think that's important to point out because INGREZZA is incredibly sticky.

然後我要指出的第三點是，我們的目標是最大限度地增加 INGREZZA 的患者數量，這是我們最大限度地提高訪問策略的一部分。我認為指出這一點很重要，因為 INGREZZA 的黏性極強。

Patients, when they start INGREZZA, they tend to stay on it. So when it comes to 2027 in the years between that and our own IP moment in 2029, we are talking about the new patients primarily. And we think that we're on a good footing here with the differentiation that we offer for INGREZZA relative to our competitor in this space when they go through their IP moments. So maybe I'll stop there, Eric, anything to add?

當患者開始服用 INGREZZA 時，他們往往會堅持服用。因此，當談到 2027 年和我們自己的 2029 年 IP 時刻之間的幾年時，我們主要談論的是新患者。我們認為，當我們的競爭對手經歷知識產權時刻時，我們為 INGREZZA 提供的差異化優勢使我們處於有利地位。那我可能就此打住，艾瑞克，還有什麼要補充的嗎？

Yeah. Just want to reinforce that I think we're all going to learn together in 2026 in terms of how health plans are managing various classes where there's one or more negotiated products. And certainly, our overall strategy from an access perspective is to have broad access and parity. And over time, we've been very successful with that.

是的。我只是想強調一下，我認為到 2026 年，我們將共同學習健康計畫如何管理包含一種或多種協商產品的各種類別。當然，從訪問角度來看，我們的整體策略是實現廣泛的訪問和平等。隨著時間的推移，我們在這方面取得了巨大的成功。

Obviously, we commented that in 2024, we started to see some tightening of access in terms of health plans starting to reject more claims and so on. This wasn't specific to INGREZZA. This was more of a broader industry trend, and that's carried forward into 2025. Frankly, that's one of the reasons that we've invested in access because we believe it's very important to make it as easy as possible for providers and patients to get on top.

顯然，我們評論說，到 2024 年，我們開始看到醫療計劃在拒絕更多索賠等方面的准入趨於嚴格。這並不是 INGREZZA 獨有的。這更像是一種更廣泛的行業趨勢，並將延續到 2025 年。坦白說，這是我們投資於訪問的原因之一，因為我們認為讓提供者和患者盡可能輕鬆地獲得資訊非常重要。

And certainly, these increased investments that have led to a higher proportion of covered lives in Medicare sets us up well for 2026 and beyond. So we're going to very carefully monitor the environment. But ultimately, the goals don't change. We want to help patients who want to make it available and how we go about doing that is probably going to evolve over time.

當然，這些增加的投資使得醫療保險覆蓋率更高，為我們2026年及以後的醫療保險做好了準備。因此我們將非常仔細地監測環境。但最終，目標不會改變。我們希望幫助那些想要獲得治療的患者，而我們實現這一目標的方式可能會隨著時間的推移而發展。

(technical difficulty) Amy.

（技術難題）艾米。

Okay, great. Thanks for taking my question. A question on CRENESSITY. Can you give us a sense of the penetration across the different segments of the market from a physician perspective that you've talked about. And you mentioned that at present, mostly physicians have one or two patients on treatment and that is likely to evolve over time. How long do you anticipate physicians, sort of limit to maybe, a handful of patients before they feel like they have enough experience with the treatment to start to expand that? Thank you.

好的，太好了。感謝您回答我的問題。關於 CRENESSITY 的一個問題。您能否從您談到的醫師角度向我們介紹一下不同市場領域的滲透情況？您提到，目前大多數醫生只治療一到兩個病人，這種情況可能會隨著時間的推移而改變。您預計醫生需要多長時間（可能僅限於少數患者）才會覺得自己對治療有了足夠的經驗，可以開始擴大治療範圍？謝謝。

Yeah. So I'll kind of go back to some of my prepared remarks. We recently crossed an important threshold of having over 1,000 INTERACT's submitted -- treatment forms submitted into our patient hub. And most endocrinologists that have treated have only treated one or two patients so far.

是的。因此我將回顧我準備好的一些發言。我們最近跨過了一個重要的門檻，已有超過 1,000 份 INTERACT 治療表格提交到我們的患者中心。而大多數接受過治療的內分泌科醫生迄今為止只治療過一到兩名患者。

And the reality is, as I mentioned earlier, this is sort of a thinly spread population. Most of the adult endocrinologists, if they have any classic CAH patients in their practice, they might have one or two. So in some instances, they've treated all the patients that they have.

事實是，正如我之前提到的，這是一個分佈比較稀疏的群體。大多數成人內分泌科醫生，如果他們在實踐中遇到任何典型的 CAH 患者，他們可能有一兩個。因此在某些情況下，他們已經治療了所有患者。

However, especially within pediatric endocrinology and in the centers of excellence, there's still a lot of untreated patients. And so, we have a long way to go, frankly, in terms of adoption. It's still two quarters into a launch. And there's certainly endocrinologists that we have yet to meet with and to walk through the clinical data and the labeling.

然而，特別是在兒科內分泌科和卓越中心，仍有許多患者未接受治療。因此，坦白說，在採用方面我們還有很長的路要走。該產品發布至今仍處於兩個季度的時間。當然，我們還沒有與內分泌學家會面，也沒有與他們討論臨床數據和標籤。

So, I would say, if you want to try and back calculate how many prescribers there are, certainly looking at the number of treatment forms coming in and sort of that ratio where most have only one or two, you can get a sense that it's less than that total number. But ultimately, I think that we'll see how things evolve as we move further into the launch and we continue to raise the awareness of not only the availability but of the benefits of CRENESSITY.

所以，我想說，如果你想嘗試回算一下有多少開處方者，當然要看一下進來的治療表格的數量，以及大多數只有一兩個的比例，你就可以感覺到它少於總數。但最終，我認為，隨著我們進一步推動發布，我們將看到事情如何發展，我們將繼續提高人們對 CRENESSITY 的可用性和好處的認識。

Corinne Johnson, Goldman Sachs.

高盛的科琳·約翰遜。

Hey, good afternoon, everyone. I wanted to ask on the reimbursement process from here. When do you anticipate transitioning to more of a formulary-driven process? How do you anticipate that could impact net pricing on CRENESSITY?

嘿，大家下午好。我想從這裡詢問報銷流程。您預計何時會過渡到以處方為主導的流程？您預計這會對 CRENESSITY 的淨定價產生什麼影響？

Yeah, let me tackle that. So at launch, CRENESSITY was a non-formulary drug everywhere. And our expectation is that, in some instances, health plans will decide to do a formulary review and often they'll add it to formulary. But given that it's a class of one, it's more likely that in many instances, they won't bother to do a formulary review. And it will remain as a non-formulary product. That doesn't mean that it's not covered.

是的，讓我來解決這個問題。因此，在推出時，CRENESSITY 在各地都是一種非處方藥。我們的預期是，在某些情況下，健康計畫將決定進行處方集審查，並且通常會將其添加到處方集中。但考慮到這只是一類情況，在許多情況下，他們很可能不會費心去進行處方審查。並且它仍將作為非處方產品。這並不意味著它沒有被覆蓋。

And certainly, we're very pleased with the rate of reimbursement that we're seeing. Our expectation coming out of the gate with the approval was that, in most instances, patients would need to go on to our free goods program for a month or possibly longer before getting their prescription claim approved and then transitioning over to commercially reimbursed product.

當然，我們對看到的報銷率感到非常滿意。我們在獲得批准後的預期是，在大多數情況下，患者需要繼續使用我們的免費商品計劃一個月或更長時間，才能獲得處方藥申請批准，然後轉為商業報銷產品。

The reality is that we've been pleasantly surprised at the fast rate of approvals for these claims. Most patients don't need to go on free goods. And thus, the statistic that over three-quarters of all the dispenses, both in Q1 and in Q2, have been reimbursed product.

事實是，這些索賠的批准速度之快讓我們感到驚訝。大多數病人不需要服用免費物品。因此，統計數據顯示，第一季和第二季的所有配藥中，超過四分之三已獲得報銷。

So just to set expectations, I don't know that we're ever going to be in a place where we'll provide formulary coverage statistics because, in many instances, health plans will continue to reimburse as a non-formulary product, given the size and scope of this category.

因此，只是為了設定預期，我不知道我們是否會提供處方集覆蓋統計數據，因為在許多情況下，考慮到這一類別的規模和範圍，健康計劃將繼續作為非處方集產品進行報銷。

Danielle Brill, Truist

丹妮爾·布里爾，Truist

Hey guys, good afternoon. Thanks for the question. You mentioned some of the data that you presented at ENDO. And I was just curious about some of the feedback that you received there from the prescribing community, specifically as it relates to like the change in glucocorticoid at one year remaining relatively flat versus 24 weeks and how we should think about that?

大家好，下午好。謝謝你的提問。您提到了在 ENDO 上展示的一些數據。我只是很好奇您從處方社區收到的一些回饋，特別是關於一年內糖皮質激素的變化與 24 週內的變化保持相對平穩，以及我們應該如何看待這一點？

And then same thing on the insulin resistance data that you presented. It seems like we don't see further benefits beyond 12 months. Is there anything to read into there? Or why might that be?

您提供的胰島素抗性數據也是一樣的。看起來我們看不到 12 個月後的進一步好處。那裡有什麼可讀的嗎？或者為什麼會這樣？

And then at any point in time, will we see any additional clinical data, such as bone age data or other benefits from lowering steroid doses?

那麼在任何時間點，我們是否會看到任何額外的臨床數據，例如骨齡數據或降低類固醇劑量的其他好處？

Eiry here. I'll address the last bit first. Yes, we do have ongoing open-label trials for CRENESSITY, both in adults and pediatrics, the adult patients being outside the United States, pediatrics being worldwide. And our intent is to continue to publish over the long haul from those studies because we do believe that those longer-term clinical data are absolutely critical.

這裡是 Eiry。我先講最後一點。是的，我們確實正在對 CRENESSITY 進行開放標籤試驗，包括成人和兒科試驗，成人患者來自美國境外，兒科患者來自世界各地。我們的目的是繼續發布這些研究的長期成果，因為我們確實相信這些長期臨床數據絕對至關重要。

Just as a reminder, this was the first time that we had presented one-year data from our registrational program. And the first time we'd really been able to concentrate on those clinical outcomes that are so important to patients and to clinicians.

提醒一下，這是我們第一次展示註冊計畫的一年數據。這是我們第一次真正能夠專注於那些對患者和臨床醫生都至關重要的臨床結果。

And just again, by means of kind of reminding everyone, the impact of crinecerfont, directly CRENESSITY, is to have a direct impact in lowering androgens. And so we're interested in understanding the long-term impact of controlling those androgens over a 12-month period and even beyond.

再次提醒大家，crinecerfont 的影響，直接的 CRENESSITY，是直接影響降低雄性激素。因此，我們有興趣了解在 12 個月甚至更長時間內控制這些雄性激素的長期影響。

And then secondly, as a result of that reduction in 17-OHP, ACTH, and androgen levels that we're able to achieve directly with CRENESSITY, we are able to reduce the steroid dosing in these patients from the superphysiologic doses that are required to control the disease in the absence of CRENESSITY.

其次，由於我們能夠透過 CRENESSITY 直接降低 17-OHP、ACTH 和雄激素水平，我們能夠將這些患者的類固醇劑量從在沒有 CRENESSITY 的情況下控制疾病所需的超生理劑量中減少。

Going into the release of data from this program, he had said, and this was supported broadly, that any reduction in steroid dose was beneficial to patients over a lifetime. And I think that is in fact what is playing out.

在發布該計劃的數據時，他曾表示，類固醇劑量的任何減少對患者的一生都是有益的，這一點得到了廣泛的支持。我認為這實際上正在發生。

What we saw in the one-year data was a consistent, small, modest effect, but a consistent effect across many metabolic parameters including weight, HOMA-IR, the insulin resistance that you referred to. And you know, that is a clinically beneficial change that we saw there that results in a potential for improved outcomes over a lifetime for those patients. So it's extremely important.

我們在一年的數據中看到的是一種一致的、小的、適度的影響，但對許多代謝參數（包括體重、HOMA-IR、您提到的胰島素抗性）有一致的影響。你知道，這是我們看到的具有臨床益處的變化，它有可能改善這些患者一生的治療結果。所以這非常重要。

We also saw changes in scores, such as hirsutism scores in females, which are important in terms of looking at the direct androgen effect. So with the release of all of those data, I will say that the response from the community was actually very positive. Clinicians were very interested and excited in the data, looking forward to obviously continuing to follow those data over time. But it's a really good start from our point of view in terms of how we're able to serve patients

我們也看到了評分的變化，例如女性多毛症評分，這對於觀察雄性激素的直接效應非常重要。因此，隨著所有這些數據的發布，我可以說社群的反應實際上非常積極。臨床醫生對這些數據非常感興趣和興奮，顯然希望能夠隨著時間的推移繼續追蹤這些數據。但從我們的角度來看，就我們如何為患者服務而言，這確實是一個很好的開始

Ash Verma, UBS.

瑞銀的 Ash Verma。

Hi, thanks, for my question. Just a quick one on CRENESSITY formulary commentary that you made. So I don't know of the reimbursement for a six-month or one-year basis. And then when CRENESSITY is up for reauthorization for these patients, would that require steroid dose reduction based on what you can tell right now?

你好，謝謝你回答我的問題。我只想簡單談談您對 CRENESSITY 處方集所做的評論。所以我不知道六個月或一年的報銷情況。那麼，當 CRENESSITY 重新授權用於這些患者時，根據您現在所知，是否需要減少類固醇劑量？

Yeah. So if I understand your question correctly, it's related to reauthorization. What are we seeing in terms of the authorized number of fills and timing for reauthorization? What kind of criteria are required? For the most part, what we're seeing is patients either getting 6 subscriptions fills authorized initially or 12. That seems to be the pattern generally.

是的。如果我理解正確的話，你的問題與重新授權有關。就授權填充數量和重新授權時間而言，我們看到了什麼？需要什麼樣的標準？大多數情況下，我們看到患者最初獲得 6 個訂閱授權或 12 個。這似乎是普遍的模式。

And for the most part, plans have -- if they have published their approval criteria, they haven't necessarily published reauthorization criteria. But typically, what we're seeing now is sort of that first early cohort of patients that might have gotten onto commercial product early in the launch that are getting reauthorized.

在大多數情況下，如果計劃已經公佈了批准標準，那麼他們不一定會公佈重新授權標準。但通常情況下，我們現在看到的是第一批可能在產品上市初期接觸到商業產品的患者正在獲得重新授權。

Generally, it's the provider, affirming that they're benefiting from treatment. So we're not seeing any hard and fast thresholds of GC dose or GC dose change or needing to provide labs related to the ACTH or the androgens. So for the most part, the reauthorization process has been going about as smoothly as the initial authorization process.

一般來說，提供者會確認他們正在從治療中受益。因此，我們沒有看到 GC 劑量或 GC 劑量變化的任何硬性閾值，或需要提供與 ACTH 或雄激素相關的實驗室。因此，在大多數情況下，重新授權過程與初始授權過程一樣順利。

David Amsellem, Piper Sandler.

大衛·阿姆塞勒姆、派珀·桑德勒。

Thanks. So I had a question on the muscarinics in the pipeline, particularly the M1/M4 agonist, '570s. I'm sure you're watching Bristol's work with Cobenfy with significant interest. And what I wanted to ask is, to the extent that the ADEPT study in Alzheimer's psychosis reads out favorably later this year, how does that play into your development plans potentially to get more aggressive with the advancement of '570, say, in AD psychosis or potentially other indications.

謝謝。所以我對正在研發的毒蕈鹼類藥物，特別是 M1/M4 激動劑 '570s 有一個疑問。我確信您一定非常感興趣地關注布里斯托爾與科本菲的合作。我想問的是，如果今年稍後 ADEPT 對阿茲海默症精神病的研究結果良好，這對你們的開發計劃有何影響，以便更積極地推進 570 的研發，例如在阿茲海默症精神病或其他潛在適應症方面。

I know you have the schizophrenia study enrolling, but how are you thinking about that more expansively just given its mechanism and that it's precedented by another M1/M4 that's on the market? Thank you.

我知道您正在進行精神分裂症研究，但考慮到它的機制以及市場上已有的另一種 M1/M4 的先例，您如何更廣泛地考慮這個問題？謝謝。

Great. Yeah, so we are watching Cobenfy's data with interest. Of note, we have quite a robust muscarinic portfolio. So we have a number of M1-preferring as well as M4-preferring agonists, and as you mentioned, a dual M1/M4, '570.

偉大的。是的，所以我們很有興趣地關注著 Cobenfy 的數據。值得注意的是，我們擁有相當強大的毒蕈鹼產品組合。因此，我們有許多 M1 優先和 M4 優先激動劑，正如您所提到的，還有雙重 M1/M4，'570。

So we have a number of choices in terms of which ones we take to various indications. Indeed, AD psychosis is a really important indication for the field, and we are interested in that. It may be with '570, but we have other muscarinic agonists which actually may be better suited for that rather elderly population because potentially there's a superior safety profile associated with it.

因此，在針對不同適應症採取哪些措施方面，我們有很多選擇。確實，AD 精神病是該領域的一個非常重要的指徵，我們對此很感興趣。它可能與 '570 有關，但我們也有其他毒蕈鹼激動劑，它們實際上可能更適合老年人口，因為它們可能具有更高的安全性。

Are any more questions? Any more?

還有其他問題嗎？還有嗎？

No, I think that was well said. And just to pick up on what Sanjay said at the end there, I think one of the things that obviously we're watching the Cobenfy data very closely, but we do believe that the direct agonist approach here without the need for an add-back, particularly in that older population, could provide an opportunity for differentiation if we were to go forward

不，我認為說得很好。沿著 Sanjay 最後說的思路，我認為我們顯然在密切關注 Cobenfy 的數據，但我們確實相信，如果繼續推進，直接激動劑療法無需添加任何藥物，尤其是在老年人群中，可以提供差異化的機會。

Marc Goodman, Leeing Partners.

馬克古德曼（Marc Goodman），Leeing Partners。

Yeah, Matt, just to confirm, this negative 5% INGREZZA ASP comment for the year, is this a full year impact because I'm kind of assuming that the second half is lower than the first half for ASP. So when you say there's no change for ASP in 2026, are you referring to the full year ASP? Are you filing to where you actually are kind of ending the year, which is lower than kind of the average for the year, if you understand my question.

是的，馬特，只是為了確認一下，今年 INGREZZA ASP 的負面 5% 評論，這是否會對全年產生影響，因為我假設下半年的 ASP 低於上半年。那麼，當您說 2026 年 ASP 沒有變化時，您指的是全年 ASP 嗎？如果您明白我的問題，您提交的申請是否實際上在年底時低於年度平均水平。

Yeah. Regarding the 2026 -- it's a trajectory comment. How we're exiting the year in 2025 would be what you would expect to continue into 2026. So I appreciate that clarification. In addition to that, on the net price comment for the year for 2025, the negative 5% price, as you mentioned, it's more concentrated in the second half of the year. So that was a full year commentary.

是的。關於 2026 年——這是一個軌跡評論。2025 年我們結束的方式將會延續到 2026 年。我很感謝你的澄清。除此之外，關於2025年的淨價格評論，正如您所說，負5%的價格更集中在下半年。這就是全年的評論。

So it is safe to assume that the price headwind is a bit more in the second half as compared to the first half. But with that said, I think you take a step back and you look at the volume gains that we expect to have, and it's just an incredible market and feel like we're really well positioned with these formularies to continue to grow and build the market.

因此，可以安全地假設下半年的價格阻力會比上半年更大一些。但話雖如此，我認為你退一步看看我們預期的銷售成長，這只是一個令人難以置信的市場，感覺我們真的有這些處方可以繼續成長和建立市場。

Myles Minter, William Blair.

邁爾斯·明特、威廉·布萊爾。

Hey, thanks for taking the question. Can you just remind us of the discontinuation rates for CRENESSITY and the one-year open-label extensions for the pediatric and the adult studies? And is that still probably the best proxy we have for the annualized retention rates on CRENESSITY in the real world? Or are there other key factors we have to consider for potential basis?

嘿，謝謝你回答這個問題。您能否提醒我們 CRENESSITY 的停藥率以及兒科和成人研究的一年開放標籤擴展？這是否仍然是現實世界中 CRENESSITY 年度留存率的最佳代理商？或者我們還需要考慮其他潛在基礎的關鍵因素嗎？

Yeah. Hi, Myles, I think the first thing to say is that we were very favorably surprised, I guess, at how well tolerated and how safe CRENESSITY was across the adult and pediatric population. That's the first thing to say.

是的。你好，邁爾斯，我想首先要說的是，我們對 CRENESSITY 在成人和兒童人群中的耐受性和安全性感到非常驚訝。這是首先要說的。

We had just a very small number of patients discontinued during the course of the program and more than 95% of the patients roll over from both the pediatric and the adult program into the open-label extension. Many of those patients have now been on study for greater than three years. And we still continue to see very low discontinuation rates and the continued improvement in the outcome for those patients.

在計畫進行過程中，只有極少數患者停止了治療，超過 95% 的患者從兒科和成人計畫轉入開放標籤擴展計畫。許多患者目前已接受研究三年多了。我們仍然看到非常低的停藥率和這些患者的治療結果的持續改善。

So it's still early in the launch cycle for CRENESSITY, and we're watching that, of course, over these first six months. But that's a key variable as we think about what's the long-term potential of CRENESSITY. And that's something I think we're going to know a lot more here in the second half of this year as well as then into the first half of next year as you see patients getting the blood draws and understanding glucocorticoid titration. But from a safety and tolerability perspective, as Eiry said, three years of patients on therapy, we have a lot to believe in, in terms of high levels of adherence.

因此，CRENESSITY 的發布週期仍處於早期階段，當然，我們會在前六個月密切關注。但當我們思考 CRENESSITY 的長期潛力時，這是一個關鍵變數。我認為，隨著患者抽血並了解糖皮質激素滴定，我們將在今年下半年以及明年上半年對此有更多了解。但從安全性和耐受性的角度來看，正如 Eiry 所說，經過三年的治療，我們非常相信患者能夠維持較高的依從性。

Yeah. One last point to make in terms of the difference between real world and clinical trial experiences typically. And in the real world, with the medicine affordability and coverage can impact persistency, we're seeing really, really good coverage. And we believe that chronicity is very affordable for patients between the co-pay buy down and the other programs that we have. So we don't expect insurance to be a barrier to persistency.

是的。最後要說的是現實世界和臨床試驗經驗之間的典型差異。在現實世界中，藥品的可負擔性和覆蓋範圍會影響持久性，我們看到的覆蓋範圍確實非常好。我們相信，透過共同支付買斷和我們現有的其他項目，慢性病的費用對患者來說是非常實惠的。因此，我們並不認為保險會成為堅持下去的障礙。

David Huang, Deutsche Bank.

德意志銀行的 David Huang。

Hi there, congrats on the quarter and thanks for taking my questions. So first, I just wanted to ask, in terms of INGREZZA. So a competitor, so Teva reported this morning, I believe, they raised their guidance for their product standout for the year. Is there anything to maybe read into that as pertains to the relative growth of INGREZZA versus your competitors this past quarter and market share in terms of dollars?

您好，恭喜本季取得佳績，感謝您回答我的問題。所以首先，我只想問一下有關 INGREZZA 的問題。因此，我相信，作為競爭對手，Teva 今天早上報告稱，他們提高了今年產品突出表現的指導。關於 INGREZZA 相對於競爭對手上個季度的相對增長以及以美元計算的市場份額，有什麼可以解讀的嗎？

And then just quickly on CAH, I think you talked about 20,000 prevalent patients in the US, do we have a sense of what percentage is regularly followed in clinics maybe from things like medical claims data?

然後簡單談談 CAH，我記得您談到了美國有 20,000 名患病患者，我們是否可以從醫療索賠數據等方面了解診所定期跟踪的患者比例？

This is Kyle. I'll take your first question. When it comes to our competitor in the space, we don't really speak to the dynamics of their marketplace and what they're looking at, I think, from the perspective of INGREZZA I'm extremely encouraged by the volume growth that we saw this quarter. And I do want to reiterate, we increased our market share on both new to brand as well as total prescriptions.

這是凱爾。我來回答你的第一個問題。當談到我們在該領域的競爭對手時，我們並沒有真正談論他們的市場動態和他們所關注的事情，我認為，從 INGREZZA 的角度來看，我對本季度看到的銷量增長感到非常鼓舞。我想重申的是，我們在新品牌和總處方方面的市佔率都有所增加。

And so I think that we're really happy with the performance in the first half of this year. You combine that with our initiatives that we put in place, starting the year with our additional market access, and we are looking forward to a strong second half as well. So I think I'll leave that there for the time being. And then on the CRENESSITY side of things, Eric, do you want to comment on that?

所以我認為我們對今年上半年的表現非常滿意。結合我們年初實施的額外市場准入舉措，我們也期待下半年能夠表現強勁。所以我想我暫時就把它留在那裡。那麼，就 CRENESSITY 方面而言，Eric，你想對此發表評論嗎？

Yes. I just want to reiterate that our estimate is greater than 20,000 patients in the US. And the reason that it's an estimate and not a firm number is that some of these patients -- first of all, there is no specific ICD-10 diagnosis code for classic CAH. There is a CAH diagnosis code but that encompasses both classic and non patients. And if you look at the medical literature, for every classic CAH patients, there's three or possibly four non classic patients.

是的。我只是想重申，我們估計美國有超過 2 萬名患者。之所以這只是一個估計值而不是一個確定的數字，是因為其中一些患者——首先，沒有針對典型 CAH 的特定 ICD-10 診斷代碼。有一個 CAH 診斷代碼，但涵蓋經典患者和非患者。如果你查閱醫學文獻，你會發現每位典型的 CAH 患者都有三到四位非典型的 CAH 患者。

So we have had to triangulate doing a thorough medical literature review and claims data and so on to get at that number. Some of these patients don't have the CAH diagnosis code at all for various reasons. And so we feel like that 20,000 number in the US is a good estimate for the overall prevalent populations, a subset of them that are more easily findable, I guess, is the way I would put it. And certainly, there are -- that are under the care of an endocrinologist, for example.

因此，我們必須進行徹底的醫學文獻審查和索賠數據等才能得出這個數字。由於各種原因，其中一些患者根本沒有CAH診斷代碼。因此，我們認為，美國的 20,000 這個數字對於整體流行人群來說是一個很好的估計，我想，他們是其中更容易找到的一個子集，我是這樣說的。當然，有些患者需要接受內分泌科醫師的治療。

But there are certainly a cohort of classic CAH patients that are not under the care of an endocrinologist. And they're probably being seen by internal medicine, family medicine, or even OBGYN. So we will learn more about this market as we get deeper into the launch.

但確實有一群典型的 CAH 患者沒有接受內分泌科醫師的治療。他們可能正在接受內科、家庭醫學甚至婦產科的診治。因此，隨著產品的深入發布，我們將對這個市場有更多的了解。

Sumant Kulkarni, Canaccord.

Sumant Kulkarni，Canaccord。

Good afternoon. Thanks for taking my question which is science-based, but could have significant strategic stock implications. You have several years of internal experience in CRF-1 receptor antagonist, corticotropin is involved in stress response and there's some intriguing external preclinical data on binge eating and this approach.

午安.感謝您回答我的問題，這個問題有科學根據，但可能具有重大的戰略意義。您在 CRF-1 受體拮抗劑方面有數年內部經驗，促皮質素參與壓力反應，並且在暴飲暴食和這種方法方面有一些有趣的外部臨床前數據。

Now that you've presented one year data on weight related effects of CRENESSITY at ENDO, what are your thoughts on using this approach specifically for weight loss, especially as you have a longer-acting version in the works, which could help in compliance in that setting?

既然您已經在 ENDO 上展示了 CRENESSITY 對體重相關影響的一年數據，那麼您對將這種方法專門用於減肥有何看法，尤其是您正在研發一種長效版本，可以幫助在這種情況下遵守規定？

Yeah, we're clearly very encouraged by the data that we saw from the one-year readout recently at ENDO for CRENESSITY. And as you can probably imagine, we have a wealth of knowledge about CRF1 antagonism and CRF biology here at Neurocrine.

是的，我們最近在 ENDO 為 CRENESSITY 發布的一年報告數據讓我們感到非常鼓舞。您可能可以想像，在 Neurocrine 我們擁有豐富的有關 CRF1 拮抗作用和 CRF 生物學的知識。

So as we go forward, we've been considering a broad range of potential indications. And also obviously, we have a bit of other research projects in our pipeline that may well seek to address some of those challenging disease areas moving forward.

因此，隨著我們不斷前進，我們一直在考慮廣泛的潛在跡象。而且顯然，我們正在籌備一些其他研究項目，這些項目可能會在未來解決一些具有挑戰性的疾病領域。

Sean Laaman, Morgan Stanley.

摩根士丹利的肖恩拉曼。

hI. This is Michael Riad on for Sean Laaman. Thank you for taking our question. For INGREZZA, could you comment on the current volume split between the neurology, psychiatry, and long-term care channel. And regarding the double-digit volume growth that you expect this year, could you provide any more color on respective contributions to that volume growth from the respective channels?

你好。我是 Sean Laaman 的 Michael Riad。感謝您回答我們的問題。對於 INGREZZA，您能否評論一下神經病學、精神病學和長期照護管道之間的當前業務量分配。關於您預計今年銷售量將達到兩位數成長，您能否詳細說明各通路對銷售成長的貢獻？

Yeah. I mean what we saw was strong growth really across all three of the business segments. Overall, psychiatry accounts for about 60% or so of our volume -- 65% maybe in, and then the balance is split between the other two segments pretty evenly. But all of them are growing at approximately the same rate. So we're really pleased with the overall growth trajectory for the franchise.

是的。我的意思是，我們看到三個業務部門都實現了強勁成長。整體而言，精神病學約占我們業務量的 60% 左右，大概佔 65%，其餘部分則相當均勻地分配給其他兩個部分。但它們都以大致相同的速度成長。因此，我們對該系列的整體成長軌跡感到非常滿意。

Laura Chico, Wedbush Securities.

勞拉‧奇科（Laura Chico），韋德布希證券公司。

Thanks very much for taking the question. On CRENESSITY, I wanted to dive into a little bit more about the cadence of prescribing. And kind of just clarifying one, have the majority of patients transitioned from studies to paid script status at this point?

非常感謝您回答這個問題。在 CRENESSITY 上，我想更深入地了解開處方的節奏。只是想澄清一下，目前大多數患者是否已經從研究狀態轉變為付費處方狀態？

And two, as we're thinking about increasing breadth of prescribing. I guess, is there kind of an upper limit as to how many patients physicians are going to be able to manage on CRENESSITY? I guess is there any capacity constraints that you can share?

第二，我們正在考慮擴大處方範圍。我想，醫生在 CRENESSITY 上能夠管理的患者數量是否有上限？我猜想是否有可以分享的容量限制？

Yeah. We don't see any capacity constraints in terms of managing patients on CRENESSITY if it's right into how they're already being cared for, and we have a really good pharmacy partner to help with that. And so I'll leave it there.

是的。如果 CRENESSITY 的患者管理方式與現有護理方式一致，那麼我們認為在管理 CRENESSITY 患者方面不會遇到任何容量限制，而且我們有一個非常好的藥房合作夥伴來幫助我們。所以我就把它留在那裡了。

Laura, I forgot to mention, in regards to clinical trial patients, as I said earlier on the call, it's less than 40 patients. And you could assume half of them came on board in Q2, and the other half are going to come on board in Q3. So it's pretty de minimis in terms of overall new patients that are being added to therapy.

勞拉，我忘了提一下，關於臨床試驗患者，正如我之前在電話中所說的那樣，患者人數不到 40 名。你可以假設其中一半在第二季加入，而另一半將在第三季加入。因此，就接受治療的整體新患者數量而言，這是相當少的。

Evan Seigerman, BMO Capital Markets.

埃文·塞格曼 (Evan Seigerman)，BMO 資本市場。

Hi guys, thank you so much for taking my question. I want to touch on some of the thinking behind moving ’568 into Phase 3. I know the the Phase 3 trial and see a dose response. Maybe walk me through what you were able to get in the data to give you confidence in moving to this larger Phase 3 program.

大家好，非常感謝你們回答我的問題。我想談談將 568 推進至第三階段的一些想法。我了解第三階段試驗並看到了劑量反應。也許您可以向我介紹一下您從數據中得到的信息，以便讓您有信心進入這個更大的第 3 階段計劃。

Well, I think we've discussed the merits of moving '568 into Phase 3. I will mention here, we do have an INN name, so I wanted to do a shout out to the team for putting that together for us for this meeting with direct clarity. So stay tuned on that. We'll be able to put that in future correspondence and releases out there.

好吧，我想我們已經討論過將 568 移至第 3 階段的優點了。我要在這裡提一下，我們確實有一個 INN 名稱，所以我想向團隊大聲呼喊，感謝他們在這次會議上為我們清晰地整理了這個名稱。請繼續關注。我們將能夠將其寫入未來的通訊和發布中。

I think again I'll refer back to our Phase 2 commentary around the totality of the data that we have. All doses worked in our Phase 2. And for the dose that we selected for Phase 3, we hit the primary endpoint with all the secondary endpoints as well, a very attractive profile overall from an efficacy, safety, and tolerability profile. I think that will differentiate quite nicely if we're able to reproduce those results in Phase 3 relative to Cobenfy out there today.

我想我會再次回顧我們圍繞所擁有的全部數據的第二階段評論。我們第 2 階段的所有劑量均有效。對於我們為第 3 階段選擇的劑量，我們達到了主要終點以及所有次要終點，從功效、安全性和耐受性方面來看，總體而言非常有吸引力。我認為，如果我們能夠在第三階段重現與今天的 Cobenfy 相關的結果，那麼就會有很好的區分。

That will conclude the Q&A session for today. I'll turn the program back to Kyle Gano for any additional or closing remarks.

今天的問答環節就到此結束。我將把節目交還給凱爾·加諾 (Kyle Gano)，請他發表補充或結束語。

Thanks, Jess. Thank you all for your thoughtful questions and engaging discussion this afternoon. We cover a lot of ground, in particular, across our commercial portfolio and our pipeline. And I hope you're seeing a transition of the company to one defined by both revenue growth and diversity, I should say, revenue diversity moving forward with both INGREZZA and CRENESSITY. Look forward to connecting at upcoming health care conferences and certainly in our R&D Day on December 16. So thanks again for joining. Talk to you soon.

謝謝，傑西。感謝大家今天下午提出的深思熟慮的問題和積極的討論。我們的業務範圍很廣，特別是商業組合和產品線。我希望您看到公司轉型為一家以收入成長和多元化為特徵的公司，我應該說，收入多元化隨著 INGREZZA 和 CRENESSITY 的發展而不斷前進。期待在即將舉行的醫療保健會議以及 12 月 16 日的研發日進行交流。再次感謝您的加入。很快再和你聊。

Thank you ladies and gentlemen that will conclude today's call. We thank you for your participation. You may disconnect at this time.

謝謝各位女士、先生們，今天的電話會議就此結束。我們感謝您的參與。您現在可以斷開連線。