Jazz Pharmaceuticals PLC (JAZZ) 2025 Q3 法說會逐字稿

Good day and thank you for standing by. Welcome to the Jazz Pharmaceuticals's 2025 third-quarter earnings conference call.

您好，感謝您的耐心等待。歡迎參加 Jazz Pharmaceuticals 2025 年第三季財報電話會議。

(Operator Instructions) Please be advised that today's conference is being recorded.

（操作人員指示）請注意，今天的會議正在錄音。

I would now like to hand the conference over to your first speaker today, Jack Spinks, Executive Director, Investor Relations. Please go ahead.

現在，我謹將會議交給今天的第一位發言人，投資者關係執行董事傑克·斯平克斯先生。請繼續。

Thank you, operator. Good afternoon, everyone.

謝謝接線生。大家下午好。

Today, Jazz Pharmaceuticals reported its third-quarter 2025 financial results. The slide presentation accompanying this podcast is available on the Investors section of our website.

今天，Jazz Pharmaceuticals公佈了其2025年第三季財務業績。本次播客的配套幻燈片簡報可在我們網站的投資者關係版塊中找到。

Investors should also refer to the press release and the quarterly report on Form 10-Q that we issued earlier today. Both are available on our website and filed with the SEC.

投資者還應參考我們今天早些時候發布的新聞稿和 10-Q 表格季度報告。這兩份文件均可在我們的網站上查閱，並已提交給美國證券交易委員會。

On the call today are Renée Galá, President and Chief Executive Officer; Sam Pearce, Executive Vice President and Chief Commercial Officer; Robbie Iannone, Executive Vice President, Global Head of R&D, and Chief Medical Officer; and Phil Johnson, Executive Vice President and Chief Financial Officer.

今天參加電話會議的有：總裁兼執行長 Renée Galá；執行副總裁兼商務長 Sam Pearce；執行副總裁、全球研發主管兼首席醫療官 Robbie Iannone；以及執行副總裁兼財務長 Phil Johnson。

On slide 2, I'd like to remind you that today's webcast includes forward-looking statements, such as those related to our future financial and operating results, growth potential and anticipated development, regulatory and commercial milestones, which involve risks and uncertainties that could cause actual events, performance, and results to differ materially from those contained in these forward-looking statements.

在第 2 張投影片中，我想提醒各位，今天的網路直播包含前瞻性陳述，例如與我們未來的財務和經營業績、成長潛力以及預期發展、監管和商業里程碑相關的陳述，這些陳述涉及風險和不確定性，可能導致實際事件、業績和結果與這些前瞻性陳述中包含的內容存在重大差異。

We encourage you to review these risks and uncertainties described in today's press release; and under the caption Risk Factors in our annual report on Form 10-K for the fiscal year ended December 31, 2024; and our subsequent filings with the SEC, including our quarterly report on Form 10-Q for the fiscal quarter ended September 30, 2025, which identifies certain factors that may cause the company's actual events, performance, and results to differ materially from those contained in the forward-looking statements made on today's webcast.

我們鼓勵您仔細閱讀今天新聞稿中描述的這些風險和不確定性；以及截至 2024 年 12 月 31 日止財政年度的 10-K 表格年度報告中「風險因素」標題下的內容；以及我們隨後向美國證券交易委員會提交的文件，包括截至 2025 年 9 月 30 日止財政季度的 10-Q表格季度報告，其中列出了可能導致公司實際事件、業績和結果與今天網絡直播中作出的前瞻性陳述存在重大差異的某些因素。

We undertake no duty or obligation to update our forward-looking statements.

我們不承擔更新前瞻性聲明的義務。

As noted on slide 3, we will discuss non-GAAP financial measures on this webcast. Descriptions of these non-GAAP financial measures and reconciliations of GAAP to non-GAAP financial measures are included in today's press release and the slide presentation available on the Investors section of our website.

如投影片 3 所示，我們將在本次網路直播中討論非公認會計準則財務指標。這些非GAAP財務指標的說明以及GAAP與非GAAP財務指標的調節表包含在今天的新聞稿和我們網站投資者關係部分的幻燈片簡報中。

I'll now turn the call over to Renée.

現在我將把電話交給蕾妮。

Thanks, Jack. Good afternoon, everyone. Thank you for joining us to discuss Jazz's third-quarter 2025 results.

謝謝你，傑克。大家下午好。感謝您參加本次討論會，共同探討 Jazz 2025 年第三季業績。

I'm delighted to be speaking with you today as Jazz's CEO. The past three months have been energizing and productive. We delivered two FDA approvals that underscore Jazz's ability to bring highly differentiated therapies to patients with serious unmet needs. These milestones reflect the strength of our execution, dedication of our teams, and our continued momentum to drive sustainable growth and meaningful value for our patients and our shareholders.

今天能以 Jazz 執行長的身份與各位交流，我感到非常榮幸。過去三個月充滿活力，成果豐碩。我們獲得了兩項 FDA 批准，這凸顯了 Jazz 為有嚴重未滿足需求的患者提供高度差異化療法的能力。這些里程碑體現了我們強大的執行力、團隊的奉獻精神，以及我們為患者和股東創造可持續成長和有意義價值的持續動力。

Beginning on slide 5, the results of the quarter reflect that momentum. Starting with commercial, we achieved our highest-ever revenue quarter, over $1.1 billion, driven by robust growth from Xywav; EPIDIOLEX; and the early successful launch of Modeyso, the first and only drug treatment for recurrent H3 K27M-mutant diffuse midline glioma, an ultra-rare and aggressive brain tumor. Approval of Modeyso followed the acquisition of Chimerix earlier this year, reinforcing our ability to strengthen our portfolio through corporate development.

從第 5 張投影片開始，本季的結果反映了這一勢頭。從商業角度來看，我們實現了有史以來最高的季度收入，超過 11 億美元，這得益於 Xywav 和 EPIDIOLEX 的強勁增長，以及 Modeyso 的早期成功上市。 Modeyso 是第一個也是唯一一個用於治療復發性 H3 K27M 突變瀰漫性中線膠質瘤（一種極為罕見且具侵襲性的腦腫瘤）的藥物。繼今年稍早收購 Chimerix 之後，Modeyso 獲得批准，這進一步增強了我們透過企業發展來加強產品組合的能力。

We also secured FDA approval for Zepzelca in combination with Atezolizumab as a first-line maintenance therapy for extensive-stage small cell lung cancer. Both therapies are now included in NCCN guidelines, reflecting the meaningful advancements these therapies bring to patients.

我們也獲得了 FDA 批准 Zepzelca 與 Atezolizumab 聯合用於廣泛期小細胞肺癌的一線維持治療。這兩種療法現在都已納入 NCCN 指南，這反映了這些療法為患者帶來的重大進步。

Moving on to our pipeline, we look forward to sharing the highly anticipated top-line results from the Phase 3 zanidatamab HERIZON trial in gastroesophageal adenocarcinoma, or GEA, later this quarter. In addition, we strengthen our early-stage epilepsy pipeline through a global licensing agreement with Saniona. This agreement provides Jazz with worldwide rights to develop and commercialize SAN2355, a promising preclinical candidate designed to overcome the limitations of non-selective Kv7 targeting compounds.

接下來談談我們的研發管線，我們期待在本季稍後分享備受期待的 zanidatamab HERIZON 治療胃食道腺癌 (GEA) 的 3 期試驗的主要結果。此外，我們透過與 Saniona 達成全球授權協議，加強了我們的早期癲癇藥物研發管線。該協議賦予 Jazz 公司在全球開​​發和商業化 SAN2355 的權利，SAN2355 是一種很有前途的臨床前候選藥物，旨在克服非選擇性 Kv7 靶向化合物的局限性。

On the financial front, we remain strongly positioned to invest in the key growth drivers of our business. We narrowed our 2025 revenue guidance to a range of $4.175 million to $4.275 billion, reflecting increased confidence in our outlook at this point in the year.

在財務方面，我們仍然擁有雄厚的實力，可以投資於我們業務的關鍵成長驅動因素。我們將 2025 年的營收預期範圍縮小至 417.5 億美元至 42.75 億美元，反映出我們對今年前景的信心增強。

In addition, we were pleased to have reached settlement agreements across the entirety of the Xyrem Antitrust Litigation and the litigation with Avadel. With these matters behind us, we can focus squarely on executing our strategy, maximizing our impact for patients, and creating meaningful value for our shareholders.

此外，我們很高興就 Xyrem 反壟斷訴訟和與 Avadel 的訴訟達成了全面和解協議。這些問題解決後，我們可以全力以赴地執行我們的策略，最大限度地造福患者，並為股東創造有意義的價值。

Finally, we're thrilled to welcome Dr. Ted Love to our Board of Directors. Ted's extensive leadership in the biopharmaceutical industry and track record of driving scientific innovation, commercial success, and shareholder value will complement the capabilities of our existing Board and deepen our commitment to innovating for patients.

最後，我們非常高興地歡迎泰德·洛夫博士加入我們的董事會。Ted 在生物製藥行業的豐富領導經驗以及在推動科學創新、商業成功和股東價值方面的卓越成就，將與我們現有董事會的能力相輔相成，並深化我們對為患者進行創新的承諾。

In summary, we delivered a highly productive third quarter, with record revenues; FDA approval and rapid launch of Modeyso; completion of the Saniona licensing agreement; and, in October, litigation settlements and first-line maintenance combination approval for Zepzelca, all of which position us for a strong close of the year.

總而言之，我們第三季度取得了豐碩的成果，收入創歷史新高；Modeyso 獲得 FDA 批准並迅速上市；完成了與 Saniona 的許可協議；10 月份，Zepzelca 獲得訴訟和解以及一線維持治療組合批准，所有這些都為我們今年取得強勁的收官奠定了基礎。

I'll now turn the call over to Sam to discuss our commercial performance. After which, Rob will cover our R&D pipeline. Phil will provide a financial update. And, after that, we'll open the call to Q&A.

現在我將把電話交給 Sam，讓他來討論我們的商業表現。之後，羅布將介紹我們的研發項目。菲爾將提供財務方面的最新情況。之後，我們將開放問答環節。

Sam?

山姆？

Thank you, Renée. I'm looking forward to sharing the progress of our growing and increasingly diversified commercial portfolio today.

謝謝你，蕾妮。今天，我期待與大家分享我們不斷成長且日益多元化的商業投資組合的最新進展。

Starting on slide 7, during the third quarter, we continued to build on the positive momentum we've seen across our sleep portfolio this year. Total revenues from our sleep therapeutic area, which includes Xywav, Xyrem, and high-sodium-oxybate authorized generic royalties, was $520 million. Xywav net product sales grew 11% year over year to $431 million.

從第 7 張投影片開始，在第三季度，我們繼續鞏固了今年以來在睡眠產品組合中看到的積極勢頭。我們睡眠治療領域的總收入（包括 Xywav、Xyrem 和高鈉羥丁酸鹽授權仿製藥的特許權使用費）為 5.2 億美元。Xywav 的淨產品銷售額年增 11%，達到 4.31 億美元。

We're pleased with the strong execution of our field teams, which drove an increase of 450 net patient ads exiting the third quarter, with 125 net patient ads from narcolepsy and 325 from IH. Our field team's efforts have been bolstered by our disease awareness digital campaigns that have now been expanded to include narcolepsy, in addition to IH.

我們對現場團隊的出色執行力感到滿意，在第三季度末，淨患者廣告數量增加了 450 個，其中嗜睡症患者廣告數量增加了 125 個，IH 患者廣告數量增加了 325 個。我們的現場團隊的努力得到了疾病意識數位宣傳活動的支持，這些活動現在已擴展到包括嗜睡症，以及特發性嗜睡症。

Our Field Nurse Educator program continues to drive positive impact for patients asking therapy. This program enables new Xywav patients to interact in person with a registered nurse to receive education on titrating and optimizing their oxybate therapy and have been effective in helping patients remain on treatment.

我們的現場護理教育員計劃持續為尋求治療的患者帶來正面影響。該計劃使 Xywav 新患者能夠與註冊護士進行面對面交流，接受有關調整和優​​化羥丁酸治療的教育，並有效地幫助患者堅持治療。

The health benefits of reducing sodium intake continue to resonate with HCPs and patients, solidifying Xywav's position in the market as the only oxybate that provides the significant and clinically meaningful reduction of sodium.

減少鈉攝取量的健康益處持續受到醫療保健專業人員和患者的認可，鞏固了 Xywav 在市場上的地位，使其成為唯一一種能夠顯著且具有臨床意義地減少鈉攝入量的羥丁酸類藥物。

In August, the American Heart Association and American College of Cardiology published the 2025 High Blood Pressure Guidelines, which recommend daily sodium intake should not exceed 2,300 milligrams per day. For patients predisposed to high blood pressure, the daily intake of sodium should be less than 1,500 milligrams per day, a level which is exceeded by the recommended daily dose of all high-sodium oxybate treatment options. These recommendations are supported by the recently published XYLO study that showed switching to low-sodium Xywav from high-sodium oxybate was associated with a clinically meaningful reduction in blood pressure. These guidelines, alongside the XYLO data, reinforce our belief that every patient taking an oxybate to treat narcolepsy or IH should have the opportunity to benefit from Xywav.

今年 8 月，美國心臟協會和美國心臟病學會發布了 2025 年高血壓指南，建議每日鈉攝取量不應超過 2,300 毫克。對於易患高血壓的患者，每日鈉攝取量應少於 1500 毫克，而所有高鈉羥丁酸鹽治療方案的建議每日劑量均超過了此水準。這些建議得到了最近發表的 XYLO 研究的支持，該研究表明，從高鈉羥丁酸換成低鈉 Xywav 與血壓的臨床意義降低有關。這些指南以及 XYLO 數據進一步強化了我們的信念，即每一位服用羥丁酸治療嗜睡症或特發性嗜睡症的患者都應該有機會從 Xywav 中受益。

We carry very strong momentum with low-sodium Xywav into 2026, which is a year that brings the potential entry of one or more generic versions of our high-sodium Xyrem.

到 2026 年，低鈉 Xywav 的發展勢頭非常強勁，而 2026 年，我們高鈉 Xyrem 的一種或多種仿製藥版本可能會上市。

As a reminder, generics of Xyrem are able to enter the market early next year.

提醒大家，Xyrem 的仿製藥將於明年初進入市場。

The revenue impact to Jazz will depend on which companies enter the market, how many may enter, and how these products will be priced. We therefore recognize that the availability of generics could result in payer actions that cause some level of disruption to Xywav revenue.

Jazz 的收入影響將取決於哪些公司進入市場、有多少公司進入市場以及這些產品將如何定價。因此，我們認識到仿製藥的上市可能會導致支付方採取行動，從而對 Xywav 的收入造成一定程度的干擾。

However, even in a market with generic competitors, Xywav offers a differentiated profile. We will partner with payers to ensure that patients continue to have strong access to Xywav, the only low-sodium oxybate on the market and the only FDA-approved treatment for IH.

然而，即使在競爭激烈的市場中，Xywav 也提供了差異化的產品特性。我們將與支付方合作，確保患者能夠繼續獲得 Xywav，這是市場上唯一的低鈉羥丁酸鹽，也是唯一獲得 FDA 批准的 IH 治療藥物。

Moving to slide 8 in EPIDIOLEX, net product sales were $303 million, resulting in a 20% increase compared to the third quarter of 2024. We continue to see healthy underlying demand for EPIDIOLEX, with 10% volume growth in the quarter. Revenue this quarter also benefited from the release of reserves, following refinements of certain accrual rates here in the US.

翻到 EPIDIOLEX 的第 8 張投影片，淨產品銷售額為 3.03 億美元，比 2024 年第三季成長了 20%。我們繼續看到 EPIDIOLEX 的潛在需求保持健康成長，本季銷量成長了 10%。本季度收入也受益於儲備金的釋放，此前美國對某些應計費率進行了調整。

We are seeing sustained benefit from the robust body of real-world evidence supporting both seizure and non-seizure benefits of EPIDIOLEX, with new data from the EpiCom study, expected at the AES Annual Meeting next month. In addition, the Nurse Navigator Program has driven a meaningful improvement in persistency amongst EPIDIOLEX patients enrolled in the program.

我們看到，大量真實世界證據持續支持 EPIDIOLEX 對癲癇發作和非癲癇發作的益處，來自 EpiCom 研究的新數據預計將在下個月的 AES 年會上公佈。此外，護理導航員計劃顯著提高了參與該計劃的 EPIDIOLEX 患者的堅持治療率。

Given our solid year-to-date performance, we remain confident that EPIDIOLEX will reach blockbuster status this year.

鑑於我們今年迄今為止的穩健表現，我們仍然相信 EPIDIOLEX 今年將成為重磅炸彈級產品。

Moving to oncology on slide 9, for the third quarter of 2025, Rylaze's net product sales were $100 million, representing a 1% increase compared to the third quarter of 2024. Whilst overall asparaginase use has declined, following implementation of updated pediatric protocols, the use of Rylaze within the asparaginase class for pediatric treatment has remained stable.

在第 9 張投影片中，我們來看腫瘤學的狀況。 2025 年第三季度，Rylaze 的淨產品銷售額為 1 億美元，比 2024 年第三季成長了 1%。雖然隨著兒科治療方案的更新，天冬酰胺酶的整體使用量有所下降，但 Rylaze 在兒科治療中的使用量仍保持穩定。

Our efforts continue to be focused on ensuring optimal use of Rylaze in the pediatric setting, ensuring patients are switched to Rylaze at the first sign of a hypersensitivity reaction; and increasing Rylaze use in the adolescent and young adult population.

我們將繼續致力於確保 Rylaze 在兒科領域中得到最佳使用，確保患者在出現過敏反應的第一時間就換用 Rylaze；並提高 Rylaze 在青少年和年輕成人群體中的使用率。

On slide 10, net product sales for Zepzelca for the third quarter of 2025 were approximately $79 million, a decrease of 8% year over year due to continued competitive dynamics in the second-line setting. We were pleased to have received FDA approval for the combination of Zepzelca plus Tecentriq, expanding Zepzelca's indication into first-line maintenance therapy for extensive-stage small-cell lung cancer.

第 10 頁顯示，Zepzelca 2025 年第三季的淨產品銷售額約為 7,900 萬美元，由於二線市場持續的競爭動態，年減 8%。我們很高興獲得 FDA 批准 Zepzelca 與 Tecentriq 聯合用藥，將 Zepzelca 的適應症擴展為廣泛期小細胞肺癌的一線維持治療。

Data from the Phase 3 and [4a] trial demonstrated a statistically significant improvement in overall survival for Zepzelca in combination with Tecentriq, reducing the risk of death by 27% compared to the Tecentriq-only arm of the trial.

3 期和 [4a] 期試驗的數據顯示，Zepzelca 與 Tecentriq 聯合用藥可顯著改善總生存期，與試驗中僅使用 Tecentriq 的組別相比，死亡風險降低了 27%。

We believe these data are practice-changing. We are excited about the opportunity to help improve patient outcomes. We currently have the right team and capabilities in place to deliver a successful launch of Zepzelca in this new indication.

我們相信這些數據將改變實踐。我們很高興有機會幫助改善患者的治療效果。我們目前擁有合適的團隊和能力，能夠成功地將 Zepzelca 推向這項新的適應症。

Turning to slide 11, Modeyso became commercially available, less than two weeks after receiving accelerated approval, generating $11 million in net product sales during the third quarter of 2025. We were pleased to receive early inclusion into the NCCN guidelines as a preferred treatment for both adult and pediatric use.

翻到第 11 張投影片，Modeyso 在獲得加速批准後不到兩週就實現了商業化，並在 2025 年第三季創造了 1,100 萬美元的淨產品銷售額。我們很高興能夠儘早被納入 NCCN 指南，作為成人和兒童的首選治療方法。

Given the very high unmet need, exceptionally high awareness of Modeyso and strong patient advocacy support, we've seen rapid uptake in this early phase of the launch, with more than 200 patients having received Modeyso at the end of the third quarter. The majority of these patients were new patients, with a smaller proportion transitioning from the early access program.

鑑於目前未滿足的需求非常高，人們對 Modeyso 的認知度非常高，並且得到了患者權益倡導者的大力支持，我們在上市初期就看到了快速的普及，截至第三季度末，已有超過 200 名患者接受了 Modeyso 治療。這些患者大多數是新的患者，只有一小部分是從早期准入計畫轉過來。

We're hearing positive early feedback amongst physicians. Our comprehensive launch plan includes direct engagement with about 3,000 healthcare providers, with an additional 7,000 targeted through non-personal promotion, focusing primarily on academic Centers of Excellence where these complex cases are treated.

我們從醫生那裡得到了正面的早期回饋。我們的全面推廣計劃包括直接與約 3,000 名醫療保健提供者互動，並透過非個人推廣方式額外接觸 7,000 名醫療保健提供者，主要集中在治療這些複雜病例的學術卓越中心。

We've implemented robust patient access and support services through our exclusive distribution partnership with Onco360. These investments were made to ensure patients can access treatment quickly and easily. We're pleased with the strong payer access, thus far.

我們透過與 Onco360 的獨家分銷合作關係，實施了完善的患者准入和支援服務。這些投資旨在確保患者能夠快速且方便地獲得治療。我們對目前為止支付方的良好准入情況感到滿意。

The launch of Modeyso highlights Jazz's proven ability to advance rare disease and oncology programs through regulatory approval and commercial launch.

Modeyso 的推出凸顯了 Jazz 在推動罕見疾病和腫瘤治療計畫方面所展現出的卓越能力，包括獲得監管部門批准和商業化上市。

I'll now turn it over to Rob for an update on our pipeline and upcoming milestones. Rob?

現在我將把發言權交給羅布，讓他介紹我們的產品線和即將到來的里程碑。搶？

Thank you, Sam.

謝謝你，山姆。

Slide 13 provides an overview of the key clinical programs in our diversified pipeline, including the comprehensive clinical development program that is underway for zanidatamab. There are multiple ongoing registrational trials for zanidatamab, including the confirmatory first-line BTC trial; the HERIZON-GEA-01 trial in first-line GEA; and the advanced breast cancer trial evaluating zanidatamab's efficacy, following treatment with T-DXd.

第 13 張投影片概述了我們多元化產品線中的關鍵臨床項目，包括正在進行的 zanidatamab 綜合臨床開發項目。目前有多項針對 zanidatamab 的註冊試驗正在進行中，包括確認一線 BTC 試驗；一線 GEA 的 HERIZON-GEA-01 試驗；以及評估 zanidatamab 在 T-DXd 治療後對晚期乳癌療效的試驗。

In addition, we have earlier trials like the DiscovHER-Pan-206 (inaudible)-tumor trial and the neoadjuvant/adjuvant breast cancer trial. These trials are progressing well, with significant interest from (inaudible). We look forward to sharing an update on potential timelines for these trials, as appropriate.

此外，我們也有早期的試驗，例如 DiscovHER-Pan-206（聽不清楚）腫瘤試驗和新輔助/輔助乳癌試驗。這些試驗進展順利，引起了廣泛關注。（聽不清楚）我們將在適當的時候與大家分享這些試驗的潛在時間表。

Regarding our confirmatory Phase 3 ACTION trial of Dordaviprone in newly diagnosed H3 K27M-mutant diffuse glioma, we are in active dialogue with the FDA regarding potential updates to the trial. Pending regulatory alignment, our intent is to increase the sample size to power the trial for a primary endpoint of overall survival, which we view as the most appropriate endpoint for this confirmatory trial.

關於我們針對新診斷的 H3 K27M 突變瀰漫性膠質瘤的 Dordaviprone 的 3 期確認性 ACTION 試驗，我們正在與 FDA 積極溝通，討論該試驗的潛在更新。在監管部門同意之前，我們計劃增加樣本量，以檢驗以總生存期為主要終點的試驗結果，我們認為總生存期是本次驗證性試驗最合適的終點。

Based on these proposed updates, we currently estimate an interim analysis of the overall survival could occur in late 2026 or early 2027. The trial is active at more than 95 international sites and remains on track, with more than 50% of patients enrolled.

根據這些提議的更新，我們目前估計，對整體存活率的中期分析可能會在 2026 年末或 2027 年初進行。該試驗在超過 95 個國際地點進行，目前進展順利，已有超過 50% 的患者入組。

Moving to slide 14, our next major catalyst is the top-line readout of the Phase 3 zanidatamab HERIZON-GEA-01 trial. As we announced today and after alignment with FDA, we have updated the intent to treat patient population for PFS and now include the fully enrolled patient population, increasing the PFS cohort from the targeted 714 to 920 patients, which is the actual number of enrolled patients, as detailed on clinicaltrials.gov.

接下來是第 14 張投影片，我們的下一個主要催化劑是 zanidatamab HERIZON-GEA-01 3 期試驗的初步結果。正如我們今天宣布的那樣，在與 FDA 達成一致後，我們更新了 PFS 的治療意向患者人群，現在包括了完全入組的患者人群，將 PFS 隊列從目標 714 名患者增加到 920 名患者，這是實際入組患者人數，詳情請參見 clinicaltrials.gov。

As a reminder, we previously took the opportunity to expand the patient population for the overall survival analysis by expanding the sample size for that endpoint. With progression events accruing more slowly than anticipated, combined with the study being fully enrolled with sufficient follow-up on enrolled patients, we aligned with the FDA to conduct the PFS analysis on the entire randomized patient population.

提醒一下，我們之前曾藉此機會擴大了整體存活分析的患者族群，方法是擴大該終點的樣本量。由於進展事件的累積速度比預期的要慢，加上研究已完成入組並對入組患者進行了充分的隨訪，我們與 FDA 達成一致，對整個隨機分組的患者群體進行 PFS 分析。

Following this change, we continue to have robust powering to show a benefit for PFS. We remain highly confident that we will announce top-line results later this year, consistent with our prior guidance.

經過這項改變，我們仍然擁有強大的實力來證明 PFS 的益處。我們仍然非常有信心在今年稍後公佈業績，與我們先前的預期一致。

With that, I will turn the call over to Phil for a financial update. Phil?

接下來，我會把電話交給菲爾，讓他報告一下財務狀況。菲爾？

Thanks, Rob. I'll start on slide 16 with our top-line financial results.

謝謝你，羅伯。我將從第 16 張投影片開始，介紹我們的主要財務表現。

As a reminder, our full financial results are available in our press release and in our 10-Q.

再次提醒，我們的完整財務表現可在我們的新聞稿和 10-Q 文件中查閱。

During the third quarter of 2025, we generated $1.126 billion in total revenues. This represents an increase of 7% compared to the third quarter of 2024.

2025年第三季度，我們的總收入為11.26億美元。與 2024 年第三季相比，這相當於成長了 7%。

EPIDIOLEX grew 20% and Xywav grew 11% compared to the third quarter of last year. The continued strong performance of these products positions us well for the rest of 2025 and beyond.

與去年第三季相比，EPIDIOLEX 成長了 20%，Xywav 成長了 11%。這些產品持續強勁的表現，使我們在 2025 年剩餘時間及以後都處於有利地位。

In total, revenue from our oncology products increased 1% compared to the third quarter of 2024. This modest increase was driven primarily by the inclusion of Modeyso and Ziihera, partially offset by lower sales of Defitelio and Zepzelca.

與 2024 年第三季相比，我們腫瘤產品的總收入成長了 1%。這一小幅成長主要得益於 Modeyso 和 Ziihera 的加入，但部分被 Defitelio 和 Zepzelca 的銷售下降所抵消。

Adjusted net income, or ANI, for the third quarter of this year was $501 million. ANI was affected by several items that you'll see outlined in our press release and 10-Q, including the recognition of deferred tax assets related to the Chimerix acquisition, charges related to litigation settlements, and the Saniona licensing agreement. Cumulatively, these items increased our third-quarter non-GAAP adjusted EPS by $0.066 per share.

今年第三季的調整後淨收入（ANI）為5.01億美元。受到以下幾項因素的影響，這些因素將在我們的新聞稿和 10-Q 文件中列出，包括與 Chimerix 收購相關的遞延所得稅資產的確認、與訴訟和解相關的費用以及 Saniona 許可協議。綜合來看，這些項目使我們第三季非GAAP調整後每股盈餘增加了0.066美元。

We continue to generate robust cash flow, with nearly $1 billion recorded for the first nine months of 2025. Our balance sheet remains strong, with $2 billion in cash and investments at quarter end.

我們持續創造強勁的現金流，2025 年前九個月的現金流接近 10 億美元。截至季末，我們的資產負債表依然穩健，擁有20億美元的現金和投資。

Turning to slide 17 and guidance, revenues are tracking to our expectations. So with just one quarter left in the year, we're narrowing our full-year revenue guidance to $4.175 billion to $4.275 billion.

翻到第 17 頁投影片和業績指引，收入正朝著我們的預期發展。因此，由於今年只剩下最後一個季度，我們將全年營收預期下調至 41.75 億美元至 42.75 億美元。

We've also made several adjustments to our non-revenue guidance. In terms of ongoing run rate, we've reflected lower litigation costs in our revised SG&A guidance, as well as continued portfolio optimization and prioritization in our reduced R&D guidance range.

我們也對非營利預期進行了一些調整。就持續營運速度而言，我們在修訂後的銷售、一般及行政費用指引中反映了訴訟成本的降低，並在縮減的研發指引範圍內反映了持續的投資組合優化和優先排序。

In addition, we've also incorporated the additional antitrust, as well as Avadel litigation settlements, into our revised SG&A guidance; have included the additional IP R&D charge from the Saniona deal; and have reflected the Chimerix income tax benefit I mentioned earlier.

此外，我們還將額外的反壟斷費用以及 Avadel 訴訟和解費用納入了修訂後的銷售、一般及行政費用指引；計入了 Saniona 交易產生的額外知識產權研發費用；並反映了我之前提到的 Chimerix 所得稅優惠。

To help as you refine your models, I'd like to reiterate a point I made on last quarter's call. In the fourth quarter, we'll have 13 shipping weeks for our US oncology products. While this is a normal number of shipping weeks, it is one less week than we had in the third quarter of this year, as well as in the fourth quarter of last year.

為了幫助您完善模型，我想重申我在上個季度電話會議上提出的觀點。第四季度，我們的美國腫瘤產品將有 13 週的運輸週期。雖然這是正常的出貨週數，但比今年第三季和去年第四季都少了一周。

Finally, I'll close by providing a shout-out to our internal teams who played a key role both in our acquisition of Chimerix and in the licensing of Saniona's potentially best-in-class Kv7 molecule. These transactions have strengthened our oncology and epilepsy portfolios. We remain focused on improving Jazz's growth outlook by investing in external innovation.

最後，我要特別感謝我們的內部團隊，他們在收購 Chimerix 和獲得 Saniona 的 Kv7 分子（可能是同類最佳的分子）的許可方面都發揮了關鍵作用。這些交易增強了我們在腫瘤學和癲癇領域的業務組合。我們將繼續專注於透過投資外部創新來改善 Jazz 的成長前景。

I'm confident that in the months and quarters ahead, we'll leverage our strong financial position to execute value-creating deals that benefit patients and shareholders.

我相信，在接下來的幾個月和幾個季度裡，我們將利用我們強大的財務實力，達成有利於患者和股東的價值創造交易。

With that, I'll turn the call back to Renée for closing remarks.

接下來，我將把電話轉回給蕾妮，請她做總結發言。

Thank you, Phil. I'll conclude our prepared remarks on slide 19.

謝謝你，菲爾。我將在第19張投影片上結束我們準備好的發言。

Jazz's third-quarter results underscore the strength of our diversified portfolio and the exceptional execution of our team. We've delivered meaningful progress across our commercial portfolio, including the launches of Modeyso and Zepzelca. We'll continue to focus on ensuring our therapies reach more patients quickly.

Jazz 第三季的表現凸顯了我們多元化投資組合的實力以及我們團隊的出色執行力。我們在商業產品組合方面取得了實質進展，包括推出了 Modeyso 和 Zepzelca。我們將繼續致力於確保我們的療法能夠更快地惠及更多患者。

Looking ahead, we remain on track to share top-line results from the Phase 3 GEA trial of zanidatamab later this quarter, an important milestone for Jazz and for patients facing this aggressive cancer.

展望未來，我們仍有望在本季度稍後公佈 zanidatamab 的 3 期 GEA 試驗的主要結果，這對 Jazz 和麵臨這種侵襲性癌症的患者來說都是一個重要的里程碑。

Our focus on strong execution and disciplined capital allocation, combined with the momentum we've built, position us to deliver meaningful value to shareholders.

我們注重強而有力的執行和嚴謹的資本配置，再加上我們已經累積的發展勢頭，使我們能夠為股東創造有意義的價值。

That concludes our prepared remarks. I'd now like to turn the call over to the operator to open the line for Q&A.

我們的發言稿到此結束。現在我想把電話轉交給接線員，以便進行問答環節。

Thank you. At this time, we will conduct a question-and-answer session.

謝謝。屆時，我們將進行問答環節。

Marc Goodman, Leerink.

馬克古德曼，Leerink。

Yeah. Rob, you mentioned the Kv7 is potential best-in-class. Can you talk about how is that best-in-class? On the EPIDIOLEX, can you guys just quantify what that benefit was to gross the net? Thanks.

是的。羅布，你提到Kv7有可能成為同類最佳。你能說說它為什麼是同類最佳嗎？關於 EPIDIOLEX，你們能否量化一下這種收益對淨收益的影響？謝謝。

We believe the Kv7

我們相信Kv7

Go ahead, Sam.

請繼續，山姆。

Oh, sorry.

哦，對不起。

Go ahead, Rob.

請繼續，羅布。

Thanks, Renée. We believe the Kv7 that is in development after the Saniona deal is best-in-class because of the specificity for Kv7.2 and Kv7.3, differentiated from other molecules which have broader activity. The broader activity tends to give off-target toxicity without adding to the efficacy.

謝謝你，蕾妮。我們相信，在 Saniona 收購後正在開發的 Kv7 是同類最佳，因為它對 Kv7.2 和 Kv7.3 具有特異性，這與其他具有更廣泛活性的分子不同。更廣泛的活性往往會產生脫靶毒性，而不會增加療效。

So we think we're in a precedented validated mechanism that's potentially very impactful but with higher specificity that will potentially allow us to hit the relevant targets harder and stay off of the targets that are causing unwanted side effects.

因此，我們認為我們採用的是一種有先例可循的、經過驗證的機制，它可能具有非常大的影響，但具有更高的特異性，這將使我們能夠更有效地擊中相關目標，並避免擊中那些引起不良副作用的目標。

Thank you. I'll just jump in on the EPIDIOLEX question, Mark. It's Sam here.

謝謝。Mark，我就插一句關於EPIDIOLEX的問題吧。我是山姆。

Yeah. For EPIDIOLEX, this quarter, it was a good quarter. As you saw, $303 million, 20% revenue growth. Important, I think, for us to highlight that we saw 10% volume growth this quarter so a good, healthy, double-digit volume growth.

是的。對於EPIDIOLEX來說，本季是一個不錯的季度。正如你所看到的，營收達到 3.03 億美元，成長了 20%。我認為，值得強調的是，本季我們的銷量成長了 10%，這是一個良好、健康的兩位數銷售成長。

The revenue in the quarter was boosted not only by the volume growth but also by the refinement of certain accrual rates here in the US that gave us an impact in that third quarter. We don't expect that to have a very material impact on future quarters.

本季營收的成長不僅得益於銷售的成長，還得益於美國某些應計費率的改進，這些改進對第三季產生了影響。我們預計這不會對未來幾季產生非常實質的影響。

So you don't want to quantify it?

所以你不想量化它？

Mark, this is Phil. I'd say it's the majority of that remaining difference between the 10% volume growth and the 20% revenue growth but it's not all of it.

馬克，我是菲爾。我認為，這佔了銷量成長 10% 和營收成長 20% 之間剩餘差異的大部分，但並非全部。

Thank you. Sure.

謝謝。當然。

Jessica Fye, J.P. Morgan.

潔西卡費伊，摩根大通。

Hey, guys. Good afternoon. Thanks for taking my question.

嘿，夥計們。午安.謝謝您回答我的問題。

You mentioned that 2026 brings the generic entry of one or more generic Xyrems. Can you just elaborate on how you're thinking about the potential for other filers to enter in '26? Is your base case that there is at least one [ANDA] entrant?

您提到 2026 年將有一個或多個通用 Xyrem 進入市場。您能否詳細說明一下您是如何考慮其他申報者在 2026 年進入市場的？你的基本假設是至少有一家[ANDA]公司參賽嗎？

And then, if you'll indulge me, I am so curious, the change to the population being used for the PFS analysis for the HERIZON-GEA trial, can you just walk through the potential benefits of using the (inaudible) population for the PFS analysis, in addition to [OS]? It just seems like you're already well-powered for PFS so I'm curious what brought that about. Thank you.

然後，如果您不介意的話，我很好奇，關於HERIZON-GEA試驗中用於PFS分析的人群變化，您能否簡要說明一下，除了以下幾點之外，使用（聽不清）人群進行PFS分析的潛在好處是什麼？作業系統?看起來你已經具備了 PFS 的強大實力，所以我很好奇是什麼原因促成了這一點。謝謝。

Rob, why don't we start with the second question. And then, we can turn to Sam.

羅布，我們先從第二個問題開始。然後，我們就可以轉向薩姆了。

Sure. Thanks for the question, Jess.

當然。謝謝你的提問，傑西。

As a reminder, when we took the study over from Zymeworks, we knew we wanted to increase the sample size to ensure adequate power for overall survival, even though the study was clearly well-powered with the [714] for PFS.

提醒一下，當我們從 Zymeworks 接手這項研究時，我們就知道我們需要增加樣本量，以確保總生存期有足夠的統計效力，儘管 PFS 的統計效力顯然已經足夠強 [714]。

At the time, given our assumptions around how the PFS events would roll in, we thought there would be a big gap between the time that we were ready to read out PFS on 714 versus having enough maturity on the fully enrolled sample size.

當時，根據我們對 PFS 事件如何發生的假設，我們認為，在我們準備好讀取 714 例患者的 PFS 數據與獲得足夠成熟的完全入組樣本量之間，將存在很大的差距。

So over the course of time, the PFS events came in more slowly than we had predicted, as you know, and the trial enrolled very briskly. So we found ourselves in a situation where we actually have enough maturity on the full sample size. And so it only makes sense to look at all the patients enrolled, rather than a subset.

因此，隨著時間的推移，PFS 事件的發生速度比我們預測的要慢，正如您所知，而且試驗招募速度非常快。因此，我們發現自己處於這樣一種境地：我們實際上已經擁有了足夠成熟的完整樣本量。因此，只有查看所有入組患者才有意義，而不是只查看其中的一部分患者。

We checked that with health authorities, including the FDA, and they were aligned with that approach.

我們曾向包括美國食品藥物管理局（FDA）在內的衛生部門核實過，他們也認同這種做法。

Just coming, Jess, to your question around Xywav, as you know and as a reminder, generics are able to enter into the market from the beginning of next year. At this stage, we don't know the number of generics that would enter, when they might enter, or the price at which they will enter the market. So there are some unknowns there.

傑西，我來回答你關於 Xywav 的問題。你知道，再次提醒你一下，仿製藥從明年年初就可以進入市場了。現階段，我們尚不清楚會有多少仿製藥進入市場，它們何時會進入市場，以及它們進入市場的價格是多少。所以，這裡面還有一些未知因素。

But the availability of generics could result in payer actions that cause some disruption to Xywav revenue. We are going to continue to partner with payers to ensure that patients have access to low-sodium Xywav. We believe that's important.

但仿製藥的上市可能會導致支付方採取行動，對 Xywav 的收入造成一定影響。我們將繼續與支付方合作，確保患者能夠獲得低鈉 Xywav。我們認為這很重要。

We believe that, of course, Xywav continues to offer a really differentiated proposition to patients, being the only low sodium oxybate in the market and the only FDA-approved treatment for IH.

當然，我們相信 Xywav 將繼續為患者提供真正差異化的方案，因為它是市面上唯一的低鈉羥丁酸鹽，也是唯一獲得 FDA 批准的 IH 治療藥物。

So, yeah, that's how we're currently viewing 2026. Of course, still some things that we need to see how they'll play out in practice.

是的，這就是我們目前對 2026 年的看法。當然，有些事情我們還需要看看在實踐中會如何發展。

Andrea Newkirk, Goldman Sachs.

安德里亞·紐柯克，高盛。

Hi, everyone. Thanks so much for taking the question.

大家好。非常感謝您回答這個問題。

Sam, maybe I can follow up on Jess's question there. Just as you think about potential generic entrants, outside of maybe these negotiations with payers, are there any other strategies you might be willing to contemplate to defend against the competitive threat that might arise to the sleep franchise?

Sam，或許我可以為Jess提出的問題做個後續解答。正如您在考慮潛在的仿製藥競爭者時一樣，除了與支付方的談判之外，您是否願意考慮其他策略來抵禦睡眠產品領域可能出現的競爭威脅？

Yes. Thank you for the question, Andrea.

是的。謝謝你的提問，安德里亞。

We've been focused now. As you can see, that we've had very, very strong momentum with Xywav through the course of this year, with 11% growth. We continue to add net patient ads each quarter. We've got the highest number of active patients on treatment now. So we're carrying really strong momentum into the market.

我們現在一直專注於此。正如你所看到的，今年以來，Xywav 的發展勢頭非常強勁，成長率達到了 11%。我們每季都會持續增加淨患者廣告數量。目前我們正在接受治療的活躍患者人數最多。因此，我們帶著非常強勁的市場動能進入市場。

The things that we've been doing are going to be as relevant in 2026 as they are in 2025. The execution of our field teams has been very strong. The differentiation that we've been communicating to HCPs has really resonated well.

我們一直在做的事情，在 2026 年仍然會像在 2025 年一樣重要。我們現場團隊的執行力非常強。我們向醫療保健專業人員傳達的差異化理念確實引起了他們的共鳴。

Even in a changing environment in 2026, Xywav is going to be the only low-sodium oxybate on the market. We believe that that's still a really important differentiating proposition for customers and for patients.

即使到了 2026 年，市場環境發生變化，Xywav 仍將是市面上唯一的低鈉羥丁酸鹽產品。我們認為，這對顧客和患者來說仍然是一個非常重要的差異化優勢。

We're going to continue to invest in ensuring that that differentiation is understood. I think the AHA guidelines, which just reinforce the importance of having a low-sodium option, as well as our XYLO data, which shows the impact of switching from a high-sodium oxybate to a low-sodium oxybate, these are all really very important differentiating features.

我們將繼續加大投入，確保這種差異化優勢得到充分理解。我認為 AHA 指南強調了低鈉選擇的重要性，而我們的 XYLO 數據則顯示了從高鈉羥丁酸鹽切換到低鈉羥丁酸鹽的影響，這些都是非常重要的區別特徵。

We'll continue to communicate those to HCPs, as we enter 2026.

進入 2026 年，我們將繼續向醫療保健專業人員傳達這些資訊。

Just to add on to that, while this is not a direct strategy, relative to defend-against-impacts, I will say just noting that we did report in our 10-Q that we entered into an amendment with Hikma and that amendment to our agreement extends the agreement by two years, we do recognize that a portion of the narcolepsy market does continue to choose high-sodium oxybate by providing more therapeutic options.

補充一點，雖然這不是一項直接的策略，但就抵禦衝擊而言，我想指出的是，我們在 10-Q 報告中報告說，我們與 Hikma 達成了一項修訂協議，該修訂協議將協議期限延長了兩年。我們確實意識到，透過提供更多治療選擇，部分嗜睡症市場仍然會選擇高鈉羥丁酸鹽。

We think that's a good thing for patients. And so, of course, our royalties on the sale of authorized generics by Hikma provide us the opportunity to continue to participate in that market.

我們認為這對患者來說是件好事。因此，我們從 Hikma 授權仿製藥的銷售中獲得的特許權使用費，當然使我們有機會繼續參與該市場。

We've extended the agreement by two years. Our royalty rates are the same through the end of 2025 and then, subject to specific reductions.

我們已將協議延長兩年。我們的版稅率在 2025 年底前保持不變，之後將根據具體情況進行調整。

Of course, Hikma does maintain a right to launch a generic. If they do so, they no longer have access to our authorized generic or our [REMs]. But, as part of this, we also gain termination rights that we did not have previously, which allows us to better manage our business.

當然，Hikma 保留推出仿製藥的權利。如果他們這樣做，他們將無法再獲得我們授權的通用名藥物或我們的產品。[REMs]。但作為其中的一部分，我們也獲得了以前沒有的終止權，這使我們能夠更好地管理我們的業務。

So that's another element of our business that we think makes sense for Jazz and is important to understand.

所以，這是我們業務的另一個要素，我們認為它對爵士樂來說很有意義，而且很重要，需要了解。

Akash Tewari, Jefferies.

阿卡什‧特瓦里，傑富瑞集團。

Hey. Thanks so much.

嘿。非常感謝。

We've seen some increasingly unpredictable interactions with biotechs and the FDA, recently. How confident is your team that the FDA is okay with HERIZON-GEA having no US patients in the trial? Was that discussed when you updated the PFS analysis with the agency, recently? Thank you.

最近，我們看到生技公司與美國食品藥物管理局（FDA）之間的互動越來越難以預測。您的團隊對FDA是否接受HERIZON-GEA試驗中沒有美國患者有多大把握？最近您向監管機構更新 PFS 分析報告時，是否討論過這個問題？謝謝。

Rob, you want to jump in on that one?

羅布，你想參與討論嗎？

Yeah. Happy to. Thanks for the question, Akash.

是的。樂意之至。謝謝你的提問，阿卡什。

We've had multiple interactions with FDA and other health authorities. We're aligned on the overall design. There was a clear rationale for not accruing patients from the US. With the approval of Keytruda, it would have been a confounding factor.

我們曾多次與美國食品藥物管理局（FDA）和其他衛生部門進行溝通。我們對整體設計意見一致。不從美國招募病患是有明確理由的。如果 Keytruda 獲得批准，那將是一個令人困惑的因素。

But the FDA is really focused on it's not so much whether patients are being enrolled from the US but whether the enrolled patient population is representative of patients in the US, in terms of disease characteristics; that the trial design is well-controlled, using a control that's relevant to US patients; and that the trial conduct, including supportive care, is in line with typical supportive care so that, overall, the results would be applicable to the US population.

但FDA真正關注的重點並非患者是否來自美國，而是入組患者群體在疾病特徵方面是否具有美國患者的代表性；試驗設計是否控制良好，是否使用了與美國患者相關的對照組；以及試驗實施（包括支持性治療）是否符合典型的支持性治療，以便總體而言，試驗結果能夠適用於美國人群。

And so we've had this discussion with the FDA over multiple interactions. I'm comfortable that it's not an issue for us.

因此，我們已經就多次互動問題與FDA進行了討論。我覺得這對我們來說不是問題。

Jason Gerberry, BofA or Bank of America.

Jason Gerberry，美國銀行（BofA）。

Hey, guys. Thanks for taking my question.

嘿，夥計們。謝謝您回答我的問題。

Another follow-up on the oxybate generic for next year. I would assume by now, like November -- I remember around this time, 3Q, ahead of Aviael coming the subsequent year, you guys had a line of sight on being a parity access as an oxybate. Yeah. I'm just wondering why that is. Maybe you don't have a line of sight. Would it be your base case that to get Xywav, you're going to have to step through a generic with most insurers?

關於明年羥丁酸仿製藥的另一項後續研究。我估計到現在，大概是 11 月——我記得大約在這個時候，第三季度，在 Aviael 於次年上市之前，你們已經看到了獲得與羥丁酸類藥物同等待遇的前景。是的。我只是好奇這是為什麼。也許你視線受阻。您的基本情況是，要獲得 Xywav，您必須先透過大多數保險公司的通用名藥物才能獲得嗎？

And then, I'd love to get your thoughts just on emerging Orexin data in narcolepsy type 2. I think NT1, the data and profile is pretty reasonably well understood. But I think we are seeing less of a treatment effect size in NT2. I'm just curious how you think about the value proposition of that as a potential competitive threat to Xywav, as well. Thanks.

然後，我很想聽聽您對 2 型嗜睡症中新興的食慾素數據的看法。我認為 NT1 的數據和概況已經相當清楚了。但我認為我們在 NT2 中看到的治療效果較小。我很好奇您如何看待它對 Xywav 的潛在競爭威脅。謝謝。

Yeah. Thanks for the question, Jason. Why don't you hop in on the first one, Sam? And then, Rob, you can cover the second.

是的。謝謝你的提問，傑森。山姆，你為什麼不參加第一場？然後，羅布，你可以負責第二個。

Yeah. Thank you. Thanks for the question, Jason.

是的。謝謝。謝謝你的提問，傑森。

Yeah. So far, there has been no material change to our engagement with payers. We continue to engage with them, as we normally would do, on 2026.

是的。到目前為止，我們與付款方的合作方式還沒有實質變化。2026年，我們將繼續與他們溝通，就像我們往常一樣。

We don't have a line of sight into exactly how 2026 will play out. We know that generics are able to enter the market but we don't know yet how many there will be when they might enter and what the precise pricing conditions will be.

我們無法準確預測 2026 年的情況。我們知道仿製藥可以進入市場，但我們尚不清楚仿製藥的數量、進入時間以及具體的定價條件。

All of that, obviously, will have a bearing on the year ahead of us. Of course, we do expect that to have an impact on Xyrem revenue. But the materiality of impact of the Xywav will depend on all of those factors yet to be determined.

顯然，所有這些都將對我們未來一年產生影響。當然，我們預計這會對 Xyrem 的收入產生影響。但 Xywav 的影響程度將取決於所有這些尚未確定的因素。

Happy to answer the question related to NT2.

樂意回答與 NT2 相關的問題。

First of all, not a surprise that NT1 is more sensitive than NT2 or IH would be, given what we know about the underlying biology. I'm also not surprised to see that as data emerged, we're learning still. It's fairly early days and still learning what we'll have; which compound will have the best in class profile; how to dose; what half-life is maybe most optimal; and, ultimately, the benefit of Orexin agonists, relative to other options such as oxybates and Xywav.

首先，考慮到我們對潛在生物學的了解，NT1 比 NT2 或 IH 更敏感並不令人驚訝。看到數據不斷湧現，我們仍在學習，我並不感到驚訝。現在還處於相當早期的階段，我們仍在了解我們將擁有什麼；哪種化合物將具有同類最佳的特性；如何給藥；哪種半衰期可能是最理想的；以及最終，食慾素激動劑相對於其他選擇（如羥丁酸和 Xywav）的優勢。

I think all of the data that are emerging continue to reinforce our position that Xywav, oxybates -- Xywav being the safest of all oxybates, given the low sodium -- is really the only way to address the disruption and the abnormalities in nighttime sleep, which are the root cause of NT1, NT2, and idiopathic hypersomnia.

我認為所有湧現的數據都在不斷強化我們的觀點，即 Xywav（羥丁酸類藥物）——鑑於其低鈉特性，Xywav 是所有羥丁酸類藥物中最安全的——是解決夜間睡眠紊亂和異常的唯一方法，而夜間睡眠紊亂和異常正是 NT1、NT2 和特發性嗜睡症的根本原因。

Some of the data that we published on Xywav in World Sleep recently, I think, highlighted that, the benefit of Xywav in terms of improving those sleep parameters, which appear not to be improved when you look at total sleep or deep sleep, which is important -- not to be improved, based on the available data that we have on Orexin agonists. In fact, Orexin agonists, especially depending on the half-life, can cause insomnia and disrupt sleep.

我認為，我們最近在《世界睡眠》雜誌上發表的關於 Xywav 的一些數據突顯了 Xywav 在改善睡眠參數方面的益處，而從總睡眠或深度睡眠的角度來看，這些參數似乎並沒有得到改善，這一點很重要——根據我們目前掌握的關於食慾素激動劑的數據，深度睡眠並沒有得到改善。事實上，食慾素激動劑，尤其是根據半衰期的不同，會導致失眠和睡眠失調。

So we continue to think that while Orexin agonists are a very potent weight-promoting agent for daytime symptoms, the combination could be very powerful. It's always been the case for oxybate that patients sometimes take weight-promoting agents during the day. We think that that will continue to be the case and that Orexins will be another option there.

因此我們仍然認為，雖然食慾素激動劑是治療日間症狀的一種非常有效的增重劑，但兩者結合使用可能會非常有效。服用羥丁酸的患者有時會在白天服用促進體重增加的藥物，這種情況一直存在。我們認為這種情況還會持續下去，而食慾素將是另一種選擇。

But, as data roll out, it continues to reinforce the value of Xywav for patients who are benefiting from it.

但是，隨著數據的公佈，越來越多的證據表明 Xywav 對患者來說具有重要價值，患者也從中受益。

Thank you so much.

太感謝了。

(Operator Instructions)

（操作說明）

Ami Fadia, Needham & Company.

Ami Fadia，Needham & Company。

Hi. Good afternoon. Thanks for taking my question.

你好。午安.謝謝您回答我的問題。

Maybe just a broader one. How have your business development priorities between CNS and oncology evolved with some recent successes that you have had on the oncology side, the GEA data around the corner; but also looking a little bit ahead, the changing landscape in the sleep space? How are you thinking about where your priorities might be? Thank you for the question.

或許應該用更廣泛的語言。隨著您在腫瘤領域取得的一些最新成功，以及即將發布的 GEA 數據，您在中樞神經系統和腫瘤領域的業務發展重點發生了怎樣的變化？同時，展望未來，睡眠領域的模式也在不斷變化。你覺得你的工作重點該放在哪裡？謝謝你的提問。

First and foremost, we are highly focused on where we believe we can have a meaningful impact for patients. Whether that is within oncology, neuroscience, or neuro-oncology, that's where our primary focus is.

首先，我們高度關注那些我們認為能夠對患者產生有意義影響的領域。無論是腫瘤學、神經科學或神經腫瘤學領域，這都是我們的主要關注點。

Rob, do you want to comment further?

羅布，你還有什麼要補充的嗎？

Sure. As we highlighted in our prepared comments, we're certainly very excited about some of the near-term readouts. The fact that we now have approval and frontline in small-cell lung cancer, completely changed paradigm and a new standard of care for those patients who are in desperate need of new therapies; approval of Dordaviprone, first drug therapy approved in high-grade gliomas already having a huge impact on a very high unmet need; and then, zanidatamab approved in BTC and a lot of anticipation and excitement around the potential in GEA and beyond.

當然。正如我們在準備好的評論中所強調的那樣，我們對一些近期的數據結果感到非常興奮。我們現在在小細胞肺癌領域獲得了批准並成為一線治療藥物，這徹底改變了治療模式，為那些急需新療法的患​​者樹立了新的治療標準；多達維普隆獲批，成為首個獲批用於治療高級別膠質瘤的藥物，已經對亟部對其巨大的影響影響；

Certainly excited about our oncology franchise but also a lot of promise on the CNS side as well, with EPIDIOLEX evolving into the critically important drug that it is; and our capabilities around epilepsy enabling us to do deals like Saniona and to develop other pipeline agents that we have that we haven't necessarily disclosed the specifics of -- but continue to make us excited about areas such as epilepsy, as well.

我們當然對我們的腫瘤產品線感到興奮，但中樞神經系統方面也充滿希望，EPIDIOLEX 正在發展成為一種至關重要的藥物；我們在癲癇領域的能力使我們能夠達成像 Saniona 這樣的交易，並開發我們擁有的其他在研藥物，我們還沒有具體披露這些藥物的細節——但這些都讓我們對癲癇等領域充滿熱情。

Mohit Bansal, Wells Fargo.

莫希特·班薩爾，富國銀行。

Great. Thank you very much for taking my question.

偉大的。非常感謝您回答我的問題。

I would love if you could comment on how should we think about the authorized generic royalties for next year? When would you know that Hikma has opted in or opted out at this point, given that we are in November at this point? What should be our base case? Thank you.

如果您能就我們應該如何看待明年授權仿製藥的專利使用費發表一些意見，我將不勝感激。現在已經是11月了，您什麼時候才能知道Hikma已經選擇加入還是退出？我們的基本方案應該是什麼？謝謝。

Sure, Mohit. I'm happy to go ahead and take the questions. It's Phil.

當然可以，莫希特。我很樂意回答大家的問題。是菲爾。

At this point, our assumption is that we will have the (inaudible) provided by Hikma during 2026. The royalties, as Renée mentioned, stay at their current rate here this year and then, will be subject to step-downs. We're not providing the specific percentages that will be applied, other than to say it continues to be a meaningful royalty back to Jazz and a potential meaningful revenue stream for us, moving forward.

目前，我們假設我們將在 2026 年獲得 Hikma 提供的（聽不清楚）服務。正如蕾妮所提到的，今年的版稅將維持在目前的水平，之後將逐步降低。我們不提供具體的百分比，但可以肯定的是，這將繼續為 Jazz 帶來可觀的版稅收入，並為我們帶來未來可觀的收入來源。

Helpful. Thank you.

很有幫助。謝謝。

David Amsellem, Piper Sandler.

大衛·阿姆塞勒姆，派珀·桑德勒。

Thanks.

謝謝。

I wanted to come back to Xywav and dynamics in 2026 with Xyrem generics in the market. You made some comments about access, shoring up access. So should we take that to mean that you're going to be making some concessions on Xywav pricing?

我希望在 2026 年 Xyrem 仿製藥上市後，能夠重返 Xywav 和 Dynamics 領域。你對存取控制和加強存取控制發表了一些評論。所以我們可以理解為你們將在 Xywav 的定價方面做出一些讓步嗎？

In other words, you will see some degradation potentially in net realized price for Xywav and a cost of -- and continuing to have access and preventing switching away from Xywav?

換句話說，您可能會看到 Xywav 的淨實現價格下降，並且會產生一些成本——以及如何繼續訪問 Xywav 並防止用戶轉向其他服務商？

Is that a reasonable way to think about it or is it just too early to go there? Thanks.

這種思考方式是否合理，還是現在討論這個問題還為時過早？謝謝。

Yeah. This is Renée. I'll jump in on that one.

是的。這是蕾妮。我也想參與討論。

I would say, going into the year, we are feeling good about our current position. But I would emphasize some of the comments that Sam made previously that with the availability of generics, there could be additional actions that take place that could cause some disruption. It really does depend on how the market evolves.

我覺得，展望新的一年，我們對目前的狀況感到滿意。但我想強調 Sam 之前的一些評論，即隨著仿製藥的出現，可能會發生一些額外的事件，從而造成一些混亂。這確實取決於市場的發展趨勢。

We have a very high focus on ensuring that we have access and that is strong access. Sam talked about where we are today, with little to no step-through in order to get access to Xywav. We have focused on the clear differentiation of the product.

我們非常重視確保我們擁有暢通無阻的管道，而且是強大的管道。Sam 談到了我們目前的處境，幾乎沒有任何步驟即可訪問 Xywav。我們專注於產品的明顯差異化。

So I would say more to come, as we get into 2026. We have not provided guidance for 2026 yet nor do we typically provide guidance by product. But I would say, based on where we sit today and where poised to enter 2026, we're feeling good about the position that we're in.

所以我想說，隨著我們進入2026年，會有更多消息公佈。我們尚未提供 2026 年的業績指引，而且我們通常也不會以產品提供業績指引。但我想說，根據我們目前的處境以及我們為進入 2026 年所做的準備，我們對我們所處的位置感到滿意。

Annabel Samimy, Stifel.

Annabel Samimy，Stifel。

Hi. Great. Thanks for taking my question.

你好。偉大的。謝謝您回答我的問題。

I'm going to shift gears to oncology. I'm wondering, for Modeyso, that seems like it was a great start. Is this a bolus? Does it include stocking? What can we expect for the cadence of uptake in the coming quarters? How familiar are docs with this treatment?

我打算轉行到腫瘤學領域。我覺得，對於Modeyso來說，這似乎是一個很好的開始。這是大劑量注射嗎？包含庫存嗎？未來幾季，我們能預期產品上市的節奏如何？醫生們對這種治療方法有多熟悉？

In the same way, for the new approval or expanded label for Zepzelca, I realize that it's probably too early but the data has been out for some time now, has there been any contribution yet in the first-line setting? What can we expect on the cadence for post-approval there with the (inaudible) inclusion and the fact that it was already an available drug? Thanks.

同樣地，對於 Zepzelca 的新批准或擴大適應症，我知道現在可能還為時過早，但數據已經公佈一段時間了，一線治療方面是否已經取得了任何進展？考慮到（聽不清楚）納入標準以及該藥物已上市的事實，我們對該藥物獲批後的進展節奏有何預期？謝謝。

I'll start and then, hand it over to Sam to cover Modeyso.

我先開始，然後交給 Sam 接手 Modeyso 的工作。

Why don't I just start with Zepzelca, which is -- it's pretty early, given that we just received the actual approval. We're excited about the reaction we're hearing from physicians. They're obviously already very comfortable in using Zepzelca in the second line but too early to tell how much use is happening in the first line.

為什麼我不先從 Zepzelca 開始呢？ ——考慮到我們才剛獲得正式批准，現在還為時過早。我們對醫生們的回饋感到非常興奮。他們顯然已經非常樂意將 Zepzelca 用作二線藥物，但現在判斷一線藥物的使用還為時過早。

With respect to Modeyso, little to no stocking. That's not really how our distribution works. But super excited about this, on the back of a successful corporate development transaction. Sam?

至於Modeyso，幾乎沒有庫存。我們的分銷方式並非如此。但在此之前，我非常興奮，因為這筆企業發展交易取得了成功。山姆？

Yeah. I'll just add to that, Renée, in relation to MEDASO. We're obviously really pleased with the launch, so far. I think, $11 million in the first quarter, following FDA approval in August. Obviously, we received the NCCN guidance in pediatrics and adults, as well.

是的。Renée，關於 MEDASO，我還要補充一點。顯然，我們對目前的發布情況非常滿意。我認為，8月獲得FDA批准後，第一季營收將達到1,100萬美元。顯然，我們也收到了 NCCN 在兒科和成人方面的指導意見。

There has been, I think, really, three factors that I'd like to highlight.

我認為，真正值得強調的有三個因素。

First of all, obviously the very, very significant unmet need. We've had very strong HCP inpatient engagement. You had a question around awareness. Awareness of the product is exceptionally high. We're seeing that in the rapid uptake.

首先，顯而易見的是，存在著非常非常大的未滿足需求。我們與住院患者的醫護人員互動非常正面。你提出了一個關於意識方面的問題。該產品的知名度非常高。我們從快速普及中就能看出這一點。

We have a really experienced team behind this product dedicated to Modeyso. I think they're doing a terrific job.

我們擁有一支經驗豐富的團隊，專門負責Modeyso這款產品的研發與生產。我認為他們做得非常出色。

Access has been really, really very strong. We've got a very good partnership with our specialist distributor who are supporting patients to get onto treatment rapidly.

准入條件一直非常非常優越。我們與專業分銷商建立了非常好的合作關係，他們正在幫助患者盡快接受治療。

In terms of -- we did see -- we had about 200 -- just over 200 -- patients by the end of the third quarter. Some of those did come from the expanded access program but more than 60% of them were new patients so new to Modeyso. That's how we would continue now. That's the outlook for the forthcoming quarters: these patients will all be new to Modeyso. We're seeing a steady uptake there.

就人數而言——我們確實看到——到第三季末，我們有大約 200——略多於 200——名患者。其中一些患者來自擴大准入計劃，但超過 60% 的患者是新患者，他們之前從未接受過 Modeyso 的治療。我們現在也會繼續這樣做。接下來幾季的展望是：這些患者都將是Modeyso的新患者。我們看到那裡的市場需求穩定成長。

So confident launch and really just reinforces our belief in this product as a potentially $500 million-plus peak in the US.

如此充滿信心的發布，也更加堅定了我們對這款產品在美國市場有望達到 5 億美元以上銷售額的信心。

Brian Skorney, Baird.

Brian Skorney，Baird。

Thank you for taking my question.

感謝您回答我的問題。

Maybe for Rob, on the GEA readout, now at a sample size of 920, can you just review, are there four separate comparative analyses here or B versus A, C versus A, for OS and PFS? How to think about powering across them and the alpha split? Is there any hierarchy to the analysis?

羅布，關於 GEA 讀數，現在樣本量為 920，您能否回顧一下，這裡有四個獨立的比較分析，或者 B 對 A、C 對 A，針對 OS 和 PFS？如何考慮跨越它們以及 alpha 分割？分析中是否存在層級結構？

Yeah. While there were some early publications that detail the specifics since Jazz took on the trial, as is our usual, we don't get into the nitty-gritty of the statistics. But I would say that we do have the opportunity at this point to look at both PFS and an interim on overall survival.

是的。雖然有一些早期出版物詳細介紹了爵士樂隊接受審判後的具體情況，但像往常一樣，我們不會深入研究統計數據的細節。但我認為，目前我們有機會同時檢視無惡化存活期（PFS）和整體存活期的中期情況。

I would say a silver lining of the PFS events coming in a little more slowly is we probably have more maturity on overall survival than we might have had under protocol assumptions.

我認為，PFS 事件發生得稍慢一些也有好處，那就是我們可能比按照方案假設的情況更了解整體生存情況。

Yes, there is the opportunity to make the comparisons between both of the experimental arms and the control arm.

是的，有機會對兩個實驗組和對照組進行比較。

Having said that, we think we're very, very well-powered for PFS. Obviously, the trial is at 918, is powered for overall survival. That sometimes even makes it somewhat "overpowered" for PFS.

話雖如此，我們認為我們在 PFS 方面擁有非常非常強大的實力。顯然，該試驗有 918 名受試者，其統計效力足以得出整體存活率。對 PFS 來說，這有時甚至顯得有些「太強大」。

So we think we're well-powered for PFS. We have (inaudible) time, first of three interim analyses for us.

所以我們認為我們有能力應對 PFS。我們有（聽不清楚）時間，這是我們三次中期分析中的第一次。

David Hoang, Deutsche Bank.

David Hoang，德意志銀行。

Hi. Thanks for taking my question.

你好。謝謝您回答我的問題。

I just wanted to ask another one on HERIZON-GEA. Can you just help us maybe set expectations for the level of disclosure you would have in the top-line data? Would we see things like subgroups broken out by PD-L1 expression status? Once the data is in hand, is your expectation to approach the FDA and be able to receive a full approval on this data? Thanks.

我只是想再問一個關於 HERIZON-GEA 的問題。您能否幫我們設定一下對貴公司在主要數據揭露方面所作承諾的預期水準？我們會看到像按 PD-L1 表達狀態劃分的亞組嗎？一旦掌握了數據，您是否期望向FDA提出申請並獲得基於該數據的全面批准？謝謝。

Yeah. Thanks for the question.

是的。謝謝你的提問。

On the latter part of it, yes, we do expect this would -- as a randomized controlled trial with a primary PFS endpoint and supportive overall survival, if we see a large enough benefit in PFS and we see meaningful support from OS -- bring full approval.

關於後半部分，是的，我們確實預期——作為一項以 PFS 為主要終點並以 OS 為輔助終點的隨機對照試驗，如果我們在 PFS 方面看到足夠大的獲益，並且在 OS 方面看到有意義的支持——將會獲得全面批准。

To remind you, the primary experimental question here is really, is zanidatamab superior to HERCEPTIN, which we think we have lots of data to support that it would be. That's the primary comparison.

提醒一下，這裡的主要實驗問題是，zanidatamab 是否優於 HERCEPTIN，我們認為我們有許多數據可以支持這一點。這是主要比較點。

And then, between arms B and A -- and then, in arm C, we have the opportunity to see if the addition of a PD-L1 inhibitor, specifically Atezolizumab, adds to the benefit.

然後，在 B 組和 A 組之間——然後在 C 組中，我們有機會看看添加 PD-L1 抑制劑（特別是 Atezolizumab）是否能增加療效。

We certainly will be measuring PD-L1 as a subgroup. Those subgroups aren't powered in any way but we have an opportunity to look across subgroups. But the primary question is zanidatamab versus HERCEPTIN.

我們肯定會對 PD-L1 進行亞組測量。這些子群體本身沒有任何權力，但我們有機會跨子群體進行考察。但主要問題是札尼達單抗與赫賽汀的比較。

And then, to your question of what would we be disclosing, we'll try to be as transparent as possible, as I think we were with the recent IMforte data release where we indicated [stat sig] clinically meaningful and tried to provide some color around that.

至於您提出的「我們會揭露什麼」的問題，我們將盡可能做到透明，就像我們最近發布 IMforte 數據時所做的那樣，我們指出了 [stat sig] 具有臨床意義，並試圖對此提供一些細節。

We want to be careful about disclosing specific data in a press release ahead of a peer-reviewed publication because, sometimes, that can compromise our ability to publish at a high-impact Congress and in a high-impact peer-reviewed journal, which then supports, of course, submission to NCCN guidelines, et cetera.

我們希望謹慎地在同行評審出版物發表之前透過新聞稿披露具體數據，因為有時這可能會影響我們在高影響力大會和高影響力同行評審期刊上發表文章的能力，而這當然有助於我們向 NCCN 指南等提交申請。

Ash Verma, UBS.

阿什維爾馬，瑞銀集團。

Hi. Yeah. Thanks for taking our question.

你好。是的。感謝您回答我們的問題。

Rob, just on the GEA study, if you can comment on this. I think you said, when you adopted from Zyme the study, you wanted to change just the powering assumption for OS. Is the PFS powering assumption still the same? Zyme had -- what is the 95% for the [HR] of [0.65] for arm C and the 80% for [0.73] for arm B.

Rob，關於GEA的研究，可以發表一下看法嗎？我想你說過，當你從 Zyme 那裡借鑒這項研究時，你只想改變作業系統的功率假設。PFS供電假設是否仍相同？Zyme 有－C 組 [HR] 為 [0.65] 的 95% 信賴區間是多少？ B 組 [HR] 為 [0.73] 的 80% 信賴區間是多少？

Yeah. What I wanted to point out is that when we did the deal, we knew that the study -- and, of course, Zymeworks did as well -- was underpowered for OS. For a three-arm study, it had a similar sample size to KEYNOTE-811, which had only two arms. So we knew we wanted to increase the sample size to better support power for overall survival and give us an opportunity to have two interim analyses before the final and third overall survival.

是的。我想指出的是，當我們達成這筆交易時，我們就知道這項研究——當然，Zymeworks 也知道——對於作業系統來說效力不足。對於一項三臂研究而言，它的樣本量與只有兩隻手臂的 KEYNOTE-811 相似。因此，我們知道我們需要增加樣本量，以便更好地支持總體生存率的統計功效，並給我們機會在最終和第三次總體生存率分析之前進行兩次中期分析。

At that time, we felt that PFS was well-powered, even with 714 patients, under the specific protocol assumption. So with the full sample size, we continue to think that it's very well-powered for PFS.

當時，我們認為，即使只有 714 名患者，在特定方案假設下，PFS 也具有足夠的統計效力。因此，根據完整的樣本量，我們仍然認為它對於 PFS 來說具有非常強的統計效力。

I do acknowledge that there was a publication from Zymeworks that detailed some specifics of the statistics but we haven't commented since then on specific details of the stats.

我承認 Zymeworks 曾發表過一份出版物，詳細介紹了一些統計數據的具體細節，但從那以後，我們沒有對這些統計數據的具體細節發表過評論。

But just to reinforce that: very, very comfortable with the powering around PFS. Now, we have, I think, a more robust opportunity for overall survival, including even the first two interim analyses before we have a final look.

但要再次強調的是：我對 PFS 的動力系統非常非常滿意。我認為，現在我們有了更可靠的機會來提高整體存活率，甚至包括最終分析之前的前兩次中期分析。

Joseph Thome, TD Cowen.

Joseph Thome，TD Cowen。

Hi, there. Good evening. Thank you for taking my question.

你好呀。晚安.感謝您回答我的問題。

Maybe one on the Kv7 acquisition. Can you talk a little bit about where you are going to be looking at developing these therapies? Obviously, two competitors are reasonably ahead in the focal onset seizure space but we've also seen companies look at ALS and pain.

或許可以寫一篇關於Kv7收購的文章。您能否談談您打算在哪些方面著手發展這些療法？顯然，在局部癲癇發作領域，有兩家競爭對手處於相當領先地位，但我們也看到一些公司將目光投向了 ALS 和疼痛領域。

So is there any more room left in focal onset seizures? Or are you even looking to look elsewhere, where maybe you have a little bit more of a timeline advantage? Thank you.

那麼，局部性癲癇發作領域還有進一步研究的空間嗎？或者您是否考慮過其他機會，在那裡您可能有更大的時間優勢？謝謝。

Yeah. We haven't detailed or disclosed our full development ambitions for that program yet. We are certainly thinking through that as we bring it forward to the [IND] stage.

是的。我們尚未詳細說明或披露該項目的全部發展目標。我們當然會認真考慮這個問題，並將其推進到[IND]階段。

I think what's critical, though, is what motivated us to do this particular partnership is that we feel it has the potential to be meaningfully best-in-class in a category where I feel there is substantial scientific and clinical proof of concept around the target.

但我認為關鍵在於，我們之所以促成這項合作，是因為我們認為它有潛力成為該領域真正意義上的最佳產品，而我認為該領域已經有大量的科學和臨床概念驗證。

But what we do know is that when you hit vB7 broadly, you not only get efficacy but you see unwanted tolerability issues, which have been observed in the clinic. We think that we've been able to parse them out around the subtypes so that this particular molecule being specific for Kv7.2 and .3, we think, has the potential to be much more on target for producing maximal efficacy and avoiding Kv7.4 and 7.5, which don't contribute meaningfully to efficacy and contribute to some of the tolerability issues that have been observed.

但我們確實知道，當廣泛使用vB7時，不僅會獲得療效，還會出現不良的耐受性問題，這些問題已經在臨床上觀察到。我們認為我們已經能夠根據亞型將它們解析出來，因此我們認為這種專門針對 Kv7.2 和 .3 的特定分子，更有可能達到最大療效，並避免 Kv7.4 和 7.5，因為 Kv7.4 和 7.5 對療效沒有顯著貢獻，並且會導致一些觀察到的耐受性問題。

In short, we think we have best-in-class opportunity across, certainly, focal onset seizures but in other areas where it would be relevant, as well.

簡而言之，我們認為我們在局部癲癇發作方面擁有最佳機會，而且在其他相關領域也是如此。

Asim Rana, Truist Securities.

Asim Rana，Truist Securities。

Congrats on the quarter. Thanks for taking the questions. This is Asim Rana, on for [Joon]. Just a couple from us.

恭喜你本季取得佳績。謝謝您回答問題。這是阿西姆·拉納，正在為您報道[Joon]我們兩個就說這兩點吧。

Where are you exactly with your Orexin agonist, JZP441? I know it's an open label. Just curious when we can expect an update.

你的食慾素激動劑 JZP441 目前進展如何？我知道它是開放標籤的。想知道什麼時候能有更新。

As a follow-up, (inaudible) recently reported positive top-line data in the central tremor. Is there any interest in reviving (inaudible) ?

作為後續研究，（聽不清楚）最近報告了中樞性震顫的積極初步數據。是否有人對復興感興趣？（聽不清楚）？

Rob, do you want to jump in?

羅布，你想加入嗎？

Sure. I'm happy to. No new news yet on JCP441. We are enrolling a small NT1 trial. We're seeing data emerge. Nothing to disclose yet, at the moment. But I would say we also have a back-up program that we continue to pursue.

當然。我樂意。JCP441計畫目前還沒有新的消息。我們正在招募少量 NT1 患者參與試驗。我們看到數據正在湧現。目前還沒有什麼可以透露的。但我想說，我們還有一個備用方案，我們會繼續前進。

Again, we think that the mechanism of importance has the potential to be a meaningful daytime alerting agent and very complimentary to Xywav. So we continue to be interested in that area.

我們再次認為，這種重要的機制有可能成為一種有意義的白天警報代理，並且與 Xywav 非常互補。所以我們對這個領域仍然很感興趣。

In terms of the recent announcement by (inaudible) around (inaudible) and essential tremor, we read what you did. I still have some questions around what the data actually show, given that the [IDMC] initially called the trial futile. So it'll be ultimately interesting to see what data they have and what we can learn from that.

關於（聽不清楚）最近發布的關於（聽不清楚）和原發性震顫的公告，我們已經閱讀了你們所做的一切。鑑於獨立數據監察委員會 (IDMC) 最初稱該試驗是徒勞無功的，我對數據實際顯示的內容仍有一些疑問。所以最終看看他們掌握了哪些數據，以及我們能從中了解什麼，將會很有意思。

From our own study, we felt that the data just didn't support progressing that program, relative to the other really meaningful opportunities that we have in our pipeline.

根據我們自己的研究，我們認為，相對於我們正在籌備的其他真正有意義的機會而言，數據並不支持推進該專案。

Thank you so much.

太感謝了。

Sean Laaman, Morgan Stanley.

肖恩拉曼，摩根士丹利。

Hi. This is Michael Reid, on for Sean Laaman. Thank you for taking our questions.

你好。這裡是邁克爾·里德，代肖恩·拉曼為您報道。感謝您回答我們的問題。

I wanted to drill down on some of your prior commentary. The Xywav results from DUET at World Sleep seemed really compelling. Can you help to contextualize the restoration of sleep architecture versus wake promotion with Orexins? Are they more of an accelerant instead of a competitor? If so, would you ever think about getting the results from DUET formally into the label? Are the results from DUET sufficient in that regard? Thanks so much.

我想深入探討你之前的一些評論。Xywav 在世界睡眠大會 DUET 上的表現似乎非常令人信服。您能否幫忙解釋食慾素在恢復睡眠結構和促進覺醒方面的作用？它們更像是推動者而不是競爭對手嗎？如果是這樣，您是否考慮過將DUET的成果正式納入唱片公司旗下？DUET 的結果在這方面是否足夠？非常感謝。

Yeah. Thanks for the question because I do agree that they are meaningful results. We had prior data on the effect of oxybate at night. We do think that Xywav is really the only -- oxybates are the only drug that really address the root cause of narcolepsy and idiopathic hypersomnia. Xywav, of course, is the safest, best option to do that, given that it's a low-sodium oxybate.

是的。感謝你的提問，因為我也認為這些結果很有意義。我們之前有關於羥丁酸在夜間作用的數據。我們認為 Xywav 是唯一真正能解決嗜睡症和特發性嗜睡症根本原因的藥物—羥丁酸類藥物是唯一能解決嗜睡症和特發性嗜睡症根本原因的藥物。當然，Xywav 是最安全、最好的選擇，因為它是一種低鈉羥丁酸鹽。

But, again, it reinforces that for patients like NT1 patients or even NT2 and idiopathic hypersomnia where nighttime sleep is severely disrupted -- if you take narcolepsy patients, for example, they might have over [80] -- on average, 80 -- awakenings a night and very, let's say, disrupted or less (inaudible) or deep sleep than a typical patient.

但是，這再次強調了，對於像 NT1 患者，甚至是 NT2 和特發性嗜睡症患者這樣的患者來說，夜間睡眠嚴重紊亂——例如，以發作性睡病患者為例，他們平均每晚可能會醒來超過 [80] 次，而且睡眠非常紊亂，或者比普通患者更少（聽不清）或更淺。

When you give Xywav, as these studies showed, you meaningfully improve that. That results in improved daytime symptoms, both wakefulness, as well as cataplexy.

這些研究表明，服用 Xywav 後，病情會顯著改善。這樣可以改善白天的症狀，包括清醒度和猝倒症狀。

So we think it's critical to address the underlying root cause of the disease with any therapy in these hypersomnias. Some patients certainly will benefit from additional wake-promoting agents during the day.

因此，我們認為對於這些嗜睡症患者來說，任何治療都必須找出並解決疾病的根本原因。有些患者肯定會受益於白天服用額外的促醒藥物。

We just haven't seen that with any of the other wake-promoting agents, Orexins included. The only data I've seen, so far, suggests that there may actually be insomnia and that may be worse with drugs that have a longer half-life and just don't wash out in time for the evening.

我們還沒有在其他任何促醒劑（包括食慾素）中看到這種情況。到目前為止，我看到的唯一數據表明，可能確實存在失眠，而且對於半衰期較長、無法在晚上之前完全代謝掉的藥物來說，這種情況可能會更糟。

Even the [PSG] data, which hasn't really been fully shared, suggests that there's not improvement and key parameters such as total sleep time or deep sleep. It's concerning that the insomnia may be actually resulting in worsening sleep in that first part of the night, at least.

即使是尚未完全公開的 [PSG] 數據也表明，睡眠總時長或深度睡眠等關鍵參數並沒有改善。令人擔憂的是，失眠實際上可能導致至少前半夜的睡眠品質惡化。

And so, again, we continue to think that it's an important new mechanism in hypersomnia but, ideally, will be used in combination with Xywav, certainly for those patients who are finding meaningful benefit already from Xywav.

因此，我們仍然認為這是治療嗜睡症的一個重要新機制，但理想情況下，它將與 Xywav 聯合使用，尤其對於那些已經從 Xywav 中受益的患者而言。

As to whether this could ultimately end up in the label, we certainly think that it's important information for prescribers to have. That's why we published it. I won't comment on necessarily where we are in terms of discussions with FDA on label changes related to it.

至於這最終是否會被添加到藥品標籤中，我們當然認為這對處方醫生來說是重要的訊息。這就是我們發表它的原因。我不會就我們與FDA就標籤變更相關事宜的討論進展發表評論。

Gary Nachman, Raymond James.

Gary Nachman，Raymond James。

Hey, everyone. This is Denis Reznik, on for Gary Nachman. Thanks for taking our question.

大家好。這裡是丹尼斯·雷茲尼克，代加里·納赫曼報道。感謝您回答我們的問題。

Just on Zani, assuming a positive GEA readout, how would you be thinking about pricing that scenario, relative to what it currently is for BTC? Thanks so much.

僅就 Zani 而言，假設 GEA 讀數為正，相對於目前 BTC 的價格，您會如何考慮這種情況下的定價？非常感謝。

Yeah. When we -- this is Renée -- priced Zani for BTC, we were already looking at the GEA market and keeping that broader opportunity in mind. So I would not expect to have a different price, as we are launching GEA.

是的。當我們——我是 Renée——為 Zani 的比特幣定價時，我們已經在關注 GEA 市場，並將更廣泛的機會牢記在心。因此，我認為 GEA 的定價不會有所不同。

I think with that -- that was our last question so I'd like to close today's call by thanking all our Jazz colleagues for their efforts, all of our partners and stakeholders for their continued confidence and their support.

我想說，這是我們最後一個問題了，所以我想在今天的電話會議結束前，感謝我們所有爵士樂同事的努力，感謝我們所有合作夥伴和利益相關者的持續信任和支持。

Thank you, all, for joining us.

謝謝各位的參與。

Thank you all for your participation in today's conference. This does conclude the program. You may now disconnect.

感謝各位參加今天的會議。節目到此結束。您現在可以斷開連線了。