Jazz Pharmaceuticals PLC (JAZZ) 2026 Q1 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Jazz Pharmaceuticals 2026 first-quarter earnings conference call. (Operator Instructions) Please be advised that today's conference is being recorded.

各位好，感謝您稍候。歡迎參加 Jazz Pharmaceuticals 2026 年第一季財報電話會議。（接線員指示）請注意，今日會議將被錄音。

I would now like to turn the conference over to your speaker for today, John Bluth, Head of Investor Relations. Please go ahead.

現在我想將會議交給今日的發言人——投資人關係主管 John Bluth。請開始。

Thank you and good afternoon, everyone. Today, Jazz Pharmaceuticals reported its first-quarter 2026 financial results. The slide presentation accompanying this webcast is available on the Investors section of our website along with the press release and quarterly report on Form 10-Q for the first quarter ended March 31, 2026. On the call today are Renee Gala, President and Chief Executive Officer; Sam Pearce, Chief Commercial Officer; Robbie Iannone, Global Head of R&D and Chief Medical Officer; and Phil Johnson, Chief Financial Officer.

謝謝，各位下午好。今天，Jazz Pharmaceuticals 公布了 2026 年第一季財務結果。配合本次網路直播的簡報投影片，已與新聞稿及截至 2026 年 3 月 31 日止第一季的 10-Q 季報一併發布於我們網站的「投資人」專區。今天出席電話會議的有：總裁暨執行長 Renee Gala；商務長 Sam Pearce；全球研發主管暨首席醫療長 Robbie Iannone；以及財務長 Phil Johnson。

On slide 2, I would 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. 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, 2025. We undertake no duty or obligation to update our forward-looking statements.

在第 2 張投影片，我想提醒各位，今日網路直播包含前瞻性陳述，例如與我們未來財務與營運結果、成長潛力，以及預期的研發、法規與商業里程碑相關之陳述；此等陳述涉及風險與不確定性，可能導致實際事件、表現與結果與這些前瞻性陳述所載內容有重大差異。我們鼓勵各位查閱今日新聞稿以及我們截至 2025 年 12 月 31 日止會計年度 Form 10-K 年報中「風險因素」章節所述之風險與不確定性。我們不承擔更新前瞻性陳述之任何責任或義務。

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.

如第 3 張投影片所示，我們將在本次網路直播中討論非 GAAP 財務衡量指標。這些非 GAAP 財務衡量指標之說明，以及 GAAP 與非 GAAP 財務衡量指標之調節表，均已收錄於今日新聞稿及發布於我們網站「投資人」專區的投影片簡報中。

I will now turn the call over to Renee.

現在我將把電話會議交給 Renee。

Thanks, John. Good afternoon, everyone, and thank you for joining today's conference call. Building on our record year in 2025, we are pleased to share our results from an exceptionally strong first quarter led by commercial execution across our highly differentiated products for sleep, epilepsies, and cancers. This resulted in our highest ever first quarter total revenues of $1.1 billion, reflecting more than 19% year-over-year growth, driven by the outstanding performance of Xywav, Epidiolex, Modeyso, and Zepzelca.

謝謝你，John。各位下午好，感謝各位參加今天的電話會議。在 2025 年創下創紀錄的一年之後，我們很高興分享由睡眠、癲癇與癌症等高度差異化產品的商業執行所帶動、表現格外強勁的 2026 年第一季成果。這使我們第一季總營收創下歷史新高，達 11 億美元，年增超過 19%，主要由 Xywav、Epidiolex、Modeyso 與 Zepzelca 的卓越表現所驅動。

Our commercial teams generated double-digit growth across all our promoted brands and saw strong contributions from our ongoing launches. This performance reflects the discipline and consistent efforts of our team, working with clarity and purpose to support the physicians and patients we serve. In addition to our impressive commercial performance to start the year, we are urgently advancing the development of zanidatamab for patients with HER2+ first-line locally advanced or metastatic GEA, where the unmet medical need remains significant.

我們的商業團隊在所有主推品牌上皆實現雙位數成長，並且持續上市的產品也帶來強勁貢獻。這項表現反映了團隊的紀律與一貫努力，以清晰的方向與使命感，支持我們所服務的醫師與病患。除了年初亮眼的商業表現之外，我們也正加速推進 zanidatamab 的研發，以服務 HER2+ 一線局部晚期或轉移性 GEA 病患；在此領域，未被滿足的醫療需求仍然相當顯著。

The FDA recently accepted our sBLA for Ziihera under real-time oncology review, and granted priority review with the PDUFA date of August 25, 2026. We are ready to launch Ziihera in GEA as soon as we receive FDA approval, and we expect Ziihera will become the HER2 targeted therapy of choice for HER2+ first-line GEA patients, given the magnitude of benefits seen across both experimental arms when compared to the trastuzumab control arm.

FDA 近期已在即時腫瘤審查（real-time oncology review）機制下受理我們針對 Ziihera 的 sBLA，並授予優先審查，PDUFA 日期為 2026 年 8 月 25 日。我們已準備好在取得 FDA 核准後，立即於 GEA 適應症推出 Ziihera；且鑑於與 trastuzumab 對照組相比，在兩個試驗組皆觀察到顯著效益的幅度，我們預期 Ziihera 將成為 HER2+ 一線 GEA 病患的首選 HER2 標靶治療。

In R&D, we continue to make progress across our pipeline with multiple ongoing registrations of zanidatamab trials, early stage trials evaluating oncology assets, and the early development of neuroscience and epilepsy assets. The year is also off to an excellent operational start with cash flow of over $400 million in the first quarter and non-GAAP adjusted EPS of $6.34. Our financial strength and disciplined capital allocation enable us to invest in the continued growth of our commercial portfolio and pipeline, while also positioning us to execute on business development opportunities that fit our strategic focus in rare disease.

在研發方面，我們的產品線持續取得進展，包括多項 zanidatamab 試驗正在進行註冊性研究、評估腫瘤資產的早期試驗，以及神經科學與癲癇資產的早期開發。今年在營運上也有極佳的開局：第一季現金流超過 4 億美元，非 GAAP 調整後每股盈餘（EPS）為 6.34 美元。我們的財務實力與嚴謹的資本配置，使我們得以投資於商業產品組合與研發管線的持續成長，同時也讓我們能把握符合罕見疾病策略重點的業務開發機會。

With that, I'll turn the call over to Sam to share more details on our commercial performance.

接下來我把電話會議交給 Sam，請他分享更多商業表現的細節。

Thank you, Renee. Our commercial team delivered strong results across Jazz's portfolio, with momentum from our 2025 launches and coordinated execution continuing into 2026. I'll begin on slide seven with sleep. Xywav net product sales increased 18% to $408 million in the first quarter of 2026, compared to the same period in 2025. As expected, HCPs in patients continue to drive demand for safer low sodium Xywav and we saw strong new patient growth with approximately 425 net patient adds.

謝謝你，Renee。我們的商業團隊在 Jazz 的產品組合上交出強勁成果，2025 年上市產品所帶來的動能，以及協同一致的執行力，延續至 2026 年。我將從第 7 張投影片的睡眠領域開始。2026 年第一季 Xywav 淨產品銷售額年增 18%，達 4.08 億美元（相較 2025 年同期）。如預期所示，醫療照護專業人員（HCP）與病患持續推動對更安全、低鈉的 Xywav 的需求；我們也看到強勁的新病患成長，約新增 425 名淨病患數。

There are now approximately 16,600 active patients taking Xywav, which remains the number one branded treatment for narcolepsy based on product revenues and the only FDA-approved treatment for idiopathic hypersomnia. Our field team continue to expand both the IH and narcolepsy markets by educating HCPs on the importance of addressing the full spectrum of daytime and nighttime symptoms. These efforts are complemented by digital and media campaigns to increase disease awareness and support patient education.

目前約有 16,600 名活躍病患正在使用 Xywav；以產品營收計，Xywav 仍是嗜睡症（narcolepsy）第一大品牌治療，且是唯一獲 FDA 核准用於特發性嗜睡症（idiopathic hypersomnia, IH）的治療。我們的外勤團隊持續透過教育 HCP，強調處理日間與夜間症狀全譜的重要性，以擴大 IH 與嗜睡症市場。這些努力也搭配數位與媒體活動，以提升疾病認知並支持病患教育。

Our JazzCares support services, including field-based nurse educators, support patients from initiation through titration and across the long-term treatment journey. These services remain important differentiators for Jazz.

我們的 JazzCares 支援服務（包含外勤護理教育人員）可在病患開始用藥、劑量調整（titration）以及長期治療旅程中提供支持。這些服務仍是 Jazz 的重要差異化優勢。

Moving to slide eight, an Epidiolex. Epidiolex net product sales increased 15% to $250 million in the first quarter of 2026, driven by strong underlying demand and 16% volume growth during the quarter. Expanding our reach in the adult patient population and specifically in the long-term care setting, remains a key focus and an important near-term growth opportunity. Our Nurse Navigator program continues to have a meaningful impact on improving patient persistency, and expanding utilization of this resource remains a priority for 2026.

接著看第 8 張投影片的 Epidiolex。2026 年第一季 Epidiolex 淨產品銷售額年增 15%，達 2.50 億美元，主要由強勁的基本需求所帶動，且本季銷量成長 16%。擴大我們在成人病患族群、特別是在長期照護（long-term care）場域的觸及，仍是關鍵重點，也是重要的短期成長機會。我們的 Nurse Navigator 計畫持續在提升病患治療持續性（persistency）方面產生顯著影響，而在 2026 年擴大此資源的使用仍是優先事項。

Finally, as part of our commitment to bring Epidyolex to appropriate patients in Japan, we have partnered with Nippon Zoki, a Japanese company with deep expertise in CNS disorders. Jazz remains the sponsor of the clinical trial, and Nippon Zoki will lead regulatory, distribution, and commercial activities in Japan.

最後，作為我們致力於將 Epidyolex 帶給日本適合病患的一部分，我們已與日本公司 Nippon Zoki 合作；該公司在中樞神經系統（CNS）疾病方面具備深厚專業。Jazz 仍將擔任臨床試驗的申辦方（sponsor），而 Nippon Zoki 將主導日本的法規、配送與商業活動。

Turning to our oncology portfolio, starting with Ziihera on slide 9. In the first quarter of 2026, Ziihera generated net product sales of $13 million. Feedback from biliary tract cancer physicians continues to be positive with real-world experience consistent with the clinical profile observed in our trials.

接著談我們的腫瘤產品組合，先從第 9 張投影片的 Ziihera 開始。2026 年第一季，Ziihera 淨產品銷售額為 1,300 萬美元。膽道癌（BTC）醫師的回饋持續正面，真實世界使用經驗與我們試驗中觀察到的臨床特徵一致。

We are also continuing to expand into new community-based accounts beyond academic centers, increasing awareness of Ziihera in BTC and building readiness ahead of a potential launch in GEA. As a reminder, there is a substantial customer overlap across our solid tumor footprint, including approximately 90% overlap between BTC and GEA account. We believe this positions as well to accelerate uptake in GEA following its anticipated approval and launch on or before the August 25th PDUFA date. Once approved, our existing cross-functional team will be positioned to reach target customers and support rapid adoption of this practice-changing regimen for GEA patients.

我們也持續從學術中心擴展至更多以社區為基礎的新客戶據點，提高 Ziihera 在 BTC 的認知度，並為可能在 GEA 的上市做準備。提醒各位，我們在實體腫瘤的客戶版圖中存在顯著的客戶重疊，包括 BTC 與 GEA 帳戶之間約 90% 的重疊。我們相信，這使我們在預期核准後，能在 8 月 25 日 PDUFA 日期當日或之前加速 GEA 的採用與滲透。一旦獲准，我們現有的跨職能團隊將能觸及目標客戶，並支持這一可能改變臨床實務的療法在 GEA 病患中的快速採用。

Turning to slide 10 and our GEA launch preparations. Physicians are expressing excitement and interest in the potential use of Ziihera in GEA. It has been more than 15 years since a new first-line HER2-targeted agent became available for patients with metastatic gastric cancer.

接著看第 10 張投影片與我們的 GEA 上市準備。醫師對 Ziihera 在 GEA 的潛在使用表達了興奮與興趣。距離新的第一線 HER2 標靶藥物可供轉移性胃癌病患使用，已超過 15 年。

Given the unprecedented median overall survival data of more than two years, we believe Ziihera has the potential to become the preferred HER2-directed therapy and foundational backbone for treating HER2+ first-line metastatic GEA. The addition of tislelizumab further improved survival outcomes in both PD-L1 positive and PD-L1 negative patients consistent with Ziihera's unique mechanism of action that generates an innate immune response in the tumor.

鑑於前所未見、超過兩年的整體存活期（median overall survival）數據，我們相信 Ziihera 有潛力成為首選的 HER2 導向治療，並成為治療 HER2+ 一線轉移性 GEA 的基礎骨幹療法。加入 tislelizumab 進一步改善了 PD-L1 陽性與 PD-L1 陰性病患的存活結果，這與 Ziihera 獨特的作用機轉一致；其可在腫瘤中引發先天免疫反應。

Ziihera already benefits from an established permanent J-code through its FDA approval in second-line HER2+ BTC, which we expect will simplify reimbursement in GEA and reduce the administrative burden for providers. In addition, the compelling outcomes from the HERIZON-GEA trial support our expectations for favorable payer access. Finally, our comprehensive JazzCares support services, together with Ziihera's established availability across customers' preferred distribution channels, position us to enable seamless patient access at launch.

Ziihera 已因其在二線 HER2+ BTC 的 FDA 核准而取得既定的永久 J-code，我們預期這將簡化其在 GEA 的給付報銷流程，並降低醫療提供者的行政負擔。此外，HERIZON-GEA 試驗的具說服力結果也支持我們對有利保險給付可近性的預期。最後，我們全面的 JazzCares 支援服務，加上 Ziihera 已在客戶偏好的配送通路中具備既有供應可得性，使我們在上市時能促成病患的無縫可近性。

Turning to slide 11 and Modeyso. Modeyso generated $41 million in net product sales in the first quarter of 2026. This strong early performance following its launch in August 2025 reflects the significant unmet need in H3 K27M-mutant diffuse midline glioma, high awareness driven by advocacy groups, and the value physicians see for patients. Approximately 500 patients have been treated with Modeyso since launch through the end of the first quarter.

接著看第 11 張投影片與 Modeyso。Modeyso 在 2026 年第一季創造了 4,100 萬美元的產品淨銷售額。這項於 2025 年 8 月上市後的強勁早期表現，反映出 H3 K27M 突變型瀰漫性中線膠質瘤存在顯著未被滿足的醫療需求、倡議團體帶動的高度疾病認知，以及醫師所看見對病患的價值。自上市至第一季末，約有 500 名病患接受了 Modeyso 治療。

Our highly experienced neuro-oncology field teams, including medical and access colleagues, continue to support the launch. The teams remain focused on expanding reach in community settings, whilst maintaining a well-supported presence in academic centers of excellence. Robust patient-centric support services and payer coverage continue to underpin launch momentum, and support appropriate access for patients.

我們經驗豐富的神經腫瘤學外勤團隊（包含醫學與給付可近性同仁）持續支援上市推進。團隊仍聚焦於擴大在社區醫療場域的觸及，同時在學術卓越中心維持充分支援的佈局。強健、以病患為中心的支援服務與保險給付涵蓋持續支撐上市動能，並支持病患獲得適當的治療可近性。

Moving to slide 12 and Zepzelca. In the first quarter of 2026, Zepzelca net product sales increased 60% to $101 million compared to the same period in 2025. Growth in the first quarter was primarily driven by strong uptake in the frontline maintenance setting, following FDA approval of Zepzelca in combination with Tecentriq in October of last year.

接著看第 12 張投影片與 Zepzelca。2026 年第一季，Zepzelca 產品淨銷售額較 2025 年同期成長 60%，達到 1.01 億美元。第一季的成長主要來自一線維持治療情境的強勁採用，這是在去年 10 月 FDA 核准 Zepzelca 與 Tecentriq 併用之後所帶動。

Given the strength of the IMforte clinical data and the opportunity to improve both progression-free survival and overall survival for patients with extensive stage small cell lung cancer, healthcare providers are rapidly adopting the Zepzelca combination in the first-line maintenance setting. As a result, this new indication is driving the product's strong performance. Our commercial initiatives will continue to be focused on first-line maintenance, reflecting our ongoing commitment to this priority.

鑑於 IMforte 臨床數據的力道，以及為廣泛期小細胞肺癌病患同時改善無惡化存活期與整體存活期的機會，醫療照護提供者正迅速在一線維持治療情境採用 Zepzelca 併用方案。因此，這項新適應症正推動產品的強勁表現。我們的商業推動措施將持續聚焦於一線維持治療，反映我們對此優先事項的持續承諾。

For the rest of 2026, first-line maintenance adoption is expected to grow, with second-line use decreasing due to competition and fewer Zepzelca-naive patients available for treatment. Overall, we are satisfied with the impressive commercial performance achieved across our portfolio in the first quarter and remain focused on maintaining this momentum throughout the year.

在 2026 年剩餘期間，預期一線維持治療的採用將持續成長；而二線使用則因競爭加劇以及可治療的 Zepzelca 未治療（naive）病患數量減少而下滑。整體而言，我們對第一季在整體產品組合所達成的亮眼商業表現感到滿意，並將專注於在全年維持這股動能。

With that, I'll now turn the call over to Rob to provide an update on our pipeline. Rob?

接下來，我將把電話會議交給 Rob，請他更新我們的研發管線。Rob？

Thanks, Sam. I'll start on slide 14. This is an exciting time at Jazz. In addition to our outstanding commercial execution, we are also preparing to bring zanidatamab to HER2+ first-line metastatic GEA patients. The data from the HERIZON-GEA trial definitively demonstrated that zanidatamab offers improved outcomes on all efficacy measures compared to trastuzumab and should be the new HER2-targeted agent of choice.

謝謝，Sam。我將從第 14 張投影片開始。這對 Jazz 而言是令人振奮的時刻。除了卓越的商業執行之外，我們也正準備將 zanidatamab 帶給 HER2+ 一線轉移性 GEA 病患。HERIZON-GEA 試驗的數據明確顯示，zanidatamab 在所有療效指標上相較 trastuzumab 具有更佳的治療結果，並應成為新的首選 HER2 標靶藥物。

The data also showed tislelizumab further improved survival outcomes in both PD-L1 positive and PD-L1 negative patients. The benefit, regardless of PD-L1 status, may be driven by zanidatamab's unique mechanism of action, known as biparatopic binding. This enables zanidatamab to cross-link neighboring HER2 receptors, leading to receptor clustering, which blocks HER2 growth signaling and also triggers the complement cascade.

數據亦顯示，tislelizumab 進一步改善了 PD-L1 陽性與 PD-L1 陰性病患的存活結果。這種不受 PD-L1 狀態影響的效益，可能源自 zanidatamab 獨特的作用機轉，稱為雙表位（biparatopic）結合。此機制使 zanidatamab 能交聯相鄰的 HER2 受體，導致受體聚集，進而阻斷 HER2 生長訊號，並同時啟動補體級聯反應。

Zanidatamab's ability to uniquely and broadly activate the innate immune system may in part explain the additional efficacy observed when tislelizumab was added to zanidatamab even in PD-L1 negative tumors. The triplet arm of zanidatamab, tislelizumab, and chemotherapy demonstrated improved overall survival, with a remarkable median OS of 26.4 months, representing a meaningful improvement of more than six months median OS compared to prior studies in HER2+ patients who have a poor prognosis in the metastatic setting.

Zanidatamab 以獨特且廣泛方式活化先天免疫系統的能力，或可部分解釋為何即使在 PD-L1 陰性腫瘤中，加入 tislelizumab 仍可觀察到額外療效。由 zanidatamab、tislelizumab 與化療組成的三聯治療組別顯示整體存活期改善，中位 OS 高達 26.4 個月，較先前研究中預後不佳的 HER2+ 轉移性病患之中位 OS 有超過 6 個月的具意義提升。

Among patients who had an objective response, the median duration of response was 20.7 months. Again, this benefit was observed irrespective of tumor PD-L1 status. To put this into context, in the KEYNOTE-811 trial, the duration of response for trastuzumab and pembrolizumab plus chemotherapy was 11.3 months.

在達到客觀反應的病患中，中位反應持續時間為 20.7 個月。同樣地，這項效益不受腫瘤 PD-L1 狀態影響。作為對照，在 KEYNOTE-811 試驗中，trastuzumab 與 pembrolizumab 加上化療的反應持續時間為 11.3 個月。

We are moving quickly to bring zanidatamab to HER2+ first-line metastatic GEA patients. Following the oral presentation at ASCO GI in January, we submitted the data for potential inclusion in NCCN Guidelines. We're pleased that the manuscript has been accepted for publication by a top-tier medical journal and plan to submit the peer-reviewed manuscript to NCCN once it has been published.

我們正加速將 zanidatamab 帶給 HER2+ 一線轉移性 GEA 病患。在 1 月於 ASCO GI 進行口頭報告後，我們已提交數據以供可能納入 NCCN 指南。我們很高興該論文已獲頂尖醫學期刊接受發表，並計畫在正式刊登後，將經同儕審查的稿件提交給 NCCN。

Our supplemental BLA for zanidatamab has received priority review, with a PDUFA date of August 25, 2026. We are actively engaged with the FDA in the review process, and we expect potential approval and launch of zanidatamab and GEA on or before the PDUFA date.

我們針對 zanidatamab 的補充 BLA 已獲優先審查，PDUFA 日期為 2026 年 8 月 25 日。我們正積極與 FDA 於審查過程中互動，並預期 zanidatamab 於 GEA 適應症可能在 PDUFA 日期當日或之前獲准並上市。

Turning to slide 15 in our pipeline, we have multiple clinical trials across our pipeline from early stage to registrational trials. We look forward to sharing data from some of these ongoing trials at the upcoming ASCO meeting in early June with a number of presentations on Lurbinectedin and zanidatamab.

接著看第 15 張投影片的研發管線，我們在整體管線中有多項臨床試驗，涵蓋早期階段到註冊性試驗。我們期待在 6 月初即將舉行的 ASCO 年會上分享部分進行中試驗的數據，並將有多場關於 lurbinectedin 與 zanidatamab 的發表。

The second planned interim analysis for overall survival of the zanidatamab and chemotherapy arm of the HERIZON-GEA trial is still expected mid-year. At the time of top-line readout, this arm showed a clinically meaningful effect on overall survival with a strong trend towards statistical significance compared to the control arm.

HERIZON-GEA 試驗中 zanidatamab 與化療組別的整體存活期第二次預定期中分析，仍預期於年中進行。在主要結果（top-line）讀出時，該組別相較對照組在整體存活期上呈現具臨床意義的效果，並展現朝向統計顯著性的強勁趨勢。

The next pivotal Phase 3 trial for zanidatamab is in metastatic breast cancer patients who have progressed on or are intolerant to in HER2, and trial enrollment is progressing well. We continue to expect to complete enrollment in the EmpowHER trial in the first half of 2027, with top line data anticipated in late 2027 or early 2028. Other earlier stage trials continue to progress across new indications, including a potentially registrational pan tumor basket trial and a neoadjuvant-adjuvant breast cancer trial.

Zanidatamab 下一項關鍵性第 3 期試驗將在轉移性乳癌病患中進行，對象為在 HER2 治療後疾病惡化或對其無法耐受者，目前收案進展良好。我們仍預期在 2027 年上半年完成 EmpowHER 試驗收案，並預計於 2027 年底或 2028 年初取得主要數據。其他較早期試驗亦持續在新適應症上推進，包括一項可能作為註冊性研究的泛腫瘤籃式試驗，以及一項乳癌新輔助—輔助治療試驗。

Looking ahead to later this year or early 2027, we anticipate the ongoing Phase 3 ACTION trial will have an interim overall survival readout. This trial is designed to confirm the benefit of Modeyso and support regulatory approval as frontline therapy directly following radiation instead of waiting for signs of tumor progression before treating with Modeyso. We are working with dedicated focus to both realize the full potential of our near-term opportunities and to rapidly progress our pipeline. Our in-house research and development efforts are underway, and we look forward to sharing updates on those and further pipeline progress in the future.

展望今年稍晚或 2027 年初，我們預期進行中的第 3 期 ACTION 試驗將有一次整體存活期的期中讀出。此試驗旨在確認 Modeyso 的效益，並支持其作為一線治療在放射治療後立即使用的法規核准，而非等到出現腫瘤惡化跡象後才以 Modeyso 治療。我們正以高度專注同時實現近期機會的全部潛力，並快速推進研發管線。我們的內部研發工作已在進行中，並期待未來分享相關更新以及更多管線進展。

Now I will turn the call over to Phil for a financial update. Phil?

現在我將把電話會議交給 Phil，請他提供財務更新。Phil？

Thanks, Rob. I'll start with high-level comments on our non-GAAP-adjusted P&L, as shown on slide 17. Please note that our full financial results are available in today's press release and 10-Q.

謝謝，Rob。我將先就第 17 張投影片所示的非 GAAP 調整後損益表（P&L）做高層次說明。請注意，我們完整的財務結果已公布於今日的新聞稿與 10-Q。

The outstanding execution of our field-based teams was reflected in record first quarter revenue of $1.07 billion, driven by 45% growth in our oncology portfolio, 18% growth in Xywav, and 15% growth in Epidiolex. Strong underlying performance drove the vast majority of our revenue growth.

我們外勤團隊的卓越執行反映在第一季創紀錄的 10.7 億美元營收上，主要由腫瘤產品組合成長 45%、Xywav 成長 18% 以及 Epidiolex 成長 15% 所帶動。強勁的基本面表現驅動了我們絕大部分的營收成長。

I do want to point out two smaller items that also contributed to growth this quarter. First, we had the normal 13 shipping weeks for our US oncology product this quarter. While in last year's quarter, we had 12 shipping weeks. This contributed about 2 percentage points to our worldwide revenue growth rate. Second, the significant devaluation of the US dollar led foreign exchange to contribute about one and a half percentage points to our worldwide revenue growth.

我也想指出本季還有兩個較小的項目同樣對成長有所貢獻。第一，本季我們美國腫瘤產品有正常的 13 週出貨週期；而去年同期為 12 週，這使我們全球營收成長率約增加 2 個百分點。第二，由於美元大幅貶值，外匯因素對我們全球營收成長約貢獻 1.5 個百分點。

Moving down to P&L, our non-GAAP-adjusted gross margin declined slightly year on year, primarily due to higher sales of products carrying royalties, namely Zepzelca and Modeyso. Non-GAAP-adjusted SG&A expense decreased by about $164 million. You may recall that in last year's quarter, we recognized litigation settlement expenses of $172 million. Excluding these expenses, SG&A increased by $8 million, driven by the inclusion of Modeyso expenses.

往下看損益表，我們的非 GAAP 調整後毛利率較去年同期略為下降，主要因為需支付權利金的產品銷售占比提高，尤其是 Zepzelca 與 Modeyso。非 GAAP 調整後的 SG&A 費用減少約 1.64 億美元。各位或許記得，去年同期我們認列了 1.72 億美元的訴訟和解費用。若排除該等費用，SG&A 反而增加 800 萬美元，主要由納入 Modeyso 相關費用所致。

Non-GAAP-adjusted R&D expenses increased by $13 million, primarily due to the inclusion of Modeyso clinical trial expenses and higher compensation-related expenses. Our non-GAAP-adjusted effective tax rate this quarter was slightly lower than our full-year 2026 guidance due to excess tax benefits from share-based compensation, while our shares outstanding for the quarter reflect the accounting effect of our higher share price on our convertible notes and employee stock plans. At the bottom line, we post very robust non-GAAP adjusted EPS of $6.34. Supported by our strong start to the year, we are reaffirming our full-year 2026 revenue and expense guidance, including total revenue guidance of $4.25 billion to $4.5 billion.

非 GAAP 調整後研發（R&D）費用增加 1,300 萬美元，主要由納入 Modeyso 臨床試驗費用以及較高的薪酬相關費用所致。本季非 GAAP 調整後有效稅率略低於我們 2026 全年指引，原因是股權基礎薪酬帶來的超額稅務利益；而本季流通在外股數則反映了我們較高股價對可轉換公司債與員工股票計畫的會計影響。在最終盈餘方面，我們繳出非常強勁的非 GAAP 調整後每股盈餘（EPS）6.34 美元。在今年強勁開局的支持下，我們重申 2026 全年營收與費用指引，包括總營收指引 42.5 億至 45 億美元。

Total revenue guidance for 2026 includes the assumptions you see on slide 18. As a reminder, we assume competitive dynamics in our sleep business will increase in the second half of the year, including high-sodium generics gaining volume and one or more daytime weight-promoting agents potentially entering the narcolepsy market. We also expect to see a decline in the Xyrem and high-sodium authorized as generic revenues as generic high-sodium oxidates build their volumes over the course of 2026.

2026 年總營收指引包含您在第 18 張投影片上看到的各項假設。提醒一下，我們假設睡眠業務的競爭態勢將在下半年加劇，包括高鈉學名藥的銷量提升，以及一種或多種可能促進體重增加的日間用藥可能進入嗜睡症市場。我們也預期，隨著高鈉氧化物學名藥在 2026 年期間逐步放量，Xyrem 與高鈉授權學名藥的營收將出現下滑。

And as Sam mentioned earlier, we expect a decline in second-line use of Zepzelca. Our Q1 performance and focus on disciplined capital allocation position us well to achieve our 2026 guidance.

另外，如同 Sam 先前提到的，我們預期 Zepzelca 的二線使用將下降。我們第一季的表現以及對嚴謹資本配置的專注，使我們具備良好條件達成 2026 年指引。

Moving to slide 19, our balance sheet remains strong. We continue to generate significant cash from our business, recording $408 million of cash from operations in the first quarter of the year. And we ended the first quarter with $2.9 billion in cash and investments. Our overall financial position and robust operating cash flow provides significant flexibility to invest in value-driving commercial and R&D programs, as well as in promising corporate development opportunities to support our rare disease strategy.

接著看第 19 張投影片，我們的資產負債表仍然穩健。我們持續從業務中產生可觀現金流，今年第一季營運活動現金流入為 4.08 億美元。我們在第一季末持有 29 億美元的現金與投資。我們整體財務狀況與強勁的營運現金流，提供了相當大的彈性，可投資於創造價值的商業化與研發計畫，以及具前景的企業發展機會，以支持我們的罕見疾病策略。

I will now turn the call back to Renee for closing remarks.

我現在把電話交回給 Renee，請她做結語。

Thank you, Phil. I'll conclude our prepared remarks on slide 21. The first quarter of 2026 builds on the successes we achieved in 2025. Our focused commercial execution led to more than 19% growth in the first quarter. And based on these results, we are on track to achieve our 2026 financial guidance.

謝謝你，Phil。我將在第 21 張投影片結束我們的事先準備發言。2026 年第一季延續了我們在 2025 年取得的成功。我們聚焦的商業執行帶動第一季超過 19% 的成長。基於這些結果，我們正按計畫達成 2026 年財務指引。

We look forward to several upcoming catalysts, including the second interim analysis of overall survival from the HERIZON-GEA trial mid-year. Top-line readout for overall survival for the confirmatory ACTION trial from Modeyso is expected at the end of this year or early next year. And the top-line readout from the trial evaluating zanidatamab in late-stage breast cancer post-Enhertu treatment is expected in late '27 or early 2028. We continue to build upon our proven scientific expertise and capabilities to make a meaningful impact for patients.

我們期待接下來幾項重要催化劑，包括年中 HERIZON-GEA 試驗的整體存活期第二次期中分析。Modeyso 的確認性 ACTION 試驗之整體存活期頂線結果，預計在今年底或明年初公布。此外，評估 zanidatamab 用於 Enhertu 治療後晚期乳癌的試驗，其頂線結果預計在 2027 年底或 2028 年初出爐。我們將持續以已驗證的科學專業與能力為基礎，為病患帶來有意義的影響。

Supported by our strong financial position, you should expect to see us invest in our commercial brands and pipeline and business development to broaden our portfolio in key strategic focus areas of sleep, epilepsy, and oncology, in addition to other areas of rare disease. I'd like to thank all our Jazz colleagues for their efforts and dedication to making a difference in the patient's lives that led to an exceptional first quarter. We are relentlessly focused on continuing to execute and deliver life-changing medicines to patients.

在我們強勁財務狀況的支持下，您將看到我們持續投資於商業品牌、產品線與商務開發，以在睡眠、癲癇與腫瘤等關鍵策略聚焦領域（以及其他罕見疾病領域）擴大產品組合。我也要感謝所有 Jazz 同仁的努力與投入，為病患生活帶來改變，並促成卓越的第一季表現。我們將不懈地專注於持續執行，為病患提供改變生命的藥物。

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

以上為我們的事先準備發言。接下來我想把電話交給接線員，開放 Q&A。

(Operator Instructions)

（接線員指示）

Jessica Fye, JP Morgan.

Jessica Fye，摩根大通。

Question on zanidatamab for breast cancer. So if we assume zani beats Herceptin in breast cancer and gets approved one day for use in the post-Enhertu setting, how do you expect physicians to make decisions about how to sequence agents in the context of a lack of data for other products post-Enhertu, among other things? Thank you.

關於 zanidatamab 用於乳癌的問題。若我們假設 zani 在乳癌上優於 Herceptin，並且未來某天獲准用於 Enhertu 後線治療情境，在缺乏其他產品於 Enhertu 後線的數據等情況下，您預期醫師會如何做出用藥排序（sequence）的決策？謝謝。

I am happy to address that, Jess. This is Rob Iannone. We became very interested in this space based on good advice from many key experts in the field. And the fundamental issue is that once Enhertu moves to frontline, there is very little data about which HER2 agent to select as subsequent therapy.

我很樂意回應，Jess。我是 Rob Iannone。我們在許多領域關鍵專家的良好建議下，對這個領域產生了高度興趣。根本問題在於，一旦 Enhertu 前移到一線治療，關於後續治療應選擇哪一種 HER2 藥物的數據就非常有限。

So the trial that we are running, 303, will be the first time that we definitively, in a randomized setting, evaluate zanidatamab versus what would be considered a standard of care. So we expect to be out ahead with important data that will inform decisions about whether to use zanidatamab or other HER2 agents in that space.

因此，我們正在進行的 303 試驗，將首次在隨機分派的情境下，明確評估 zanidatamab 相較於被視為標準治療（standard of care）的療法。我們預期能率先取得關鍵數據，協助在該治療情境中，釐清應使用 zanidatamab 或其他 HER2 藥物的決策。

Joseph Thome, TD Cowen.

Joseph Thome，TD Cowen。

Congrats on the quarter, and thank you for taking my question. Maybe one on Modeyso. Do you have any updated thoughts on sort of the size of this patient population? I think historically, it was thought that it was maybe 2,000 or 3,000, but it sounds like you are already hitting 500 patients. So any thoughts on that total opportunity just given the strength of that launch?

恭喜本季表現，也謝謝讓我提問。想問一下 Modeyso。對於這個病患族群規模，您是否有更新的看法？我記得過去一般認為大概是 2,000 或 3,000 人，但聽起來你們已經觸及 500 位病患了。考量這次上市的強勁表現，對整體機會規模有何想法？

And maybe a follow-up, if I can, on M&A. What is your latest thinking in terms of where you would like to go? Obviously, we have seen a lot of activity in the past few weeks in different areas. Kind of what is the sweet spot in terms of size and area of focus for Jazz moving forward? Thank you.

另外如果可以再追問一題關於併購（M&A）。您目前最新的想法是希望往哪裡走？過去幾週我們看到不同領域都有不少活動。對 Jazz 未來而言，在交易規模與聚焦領域上，什麼是最合適的甜蜜點（sweet spot）？謝謝。

Yes, hi. Sam here. I am happy to take the one on Modeyso to start with. Yeah, we're extremely pleased with the launch so far. $41 million in Q1 really gives us a lot of confidence around achieving that $500 million peak opportunity in the US. And as you mentioned, we've had 500 patients treated since launch.

好的，您好。我是 Sam。我先回答 Modeyso 的問題。我們對目前的上市進展非常滿意。第一季 4,100 萬美元的表現，讓我們對在美國達成 5 億美元峰值機會更有信心。如您所提，自上市以來我們已治療了 500 位病患。

And I think that just reflects the very high unmet need that we see in this space. Overall survival from diagnosis is just one year. So this product has had a meaningful impact, and it is supported by high awareness from physicians and obviously, very strong patient advocacy support as well.

我認為這反映出我們在此領域看到的高度未被滿足需求。從診斷起算的整體存活期只有一年。因此，這項產品帶來了實質影響，並且也獲得醫師高度認知的支持，當然也有非常強的病友倡議團體支持。

In terms of the size of the patient population, I think our best estimates are aligned to what you mentioned there, and over time, of course, we will continue to evaluate that. But we do see potential upside in duration of treatment, as well as the size of the population. What we've seen so far is that patients are staying on treatment for longer than we initially anticipated. We'll have to wait for this cohort of patients to really mature before we get a really good handle on whether the duration of treatment exceeds that we saw in the trial, which is around about ten months.

至於病患族群規模，我認為我們目前最佳估計與您剛提到的數字一致，當然隨著時間推進我們也會持續評估。不過，我們確實看到治療持續時間以及族群規模都有上行潛力。目前看到的是，病患維持治療的時間比我們最初預期更長。我們需要等待這批病患隊列更成熟，才能更清楚掌握治療持續時間是否會超過我們在試驗中看到的水準，也就是大約 10 個月左右。

But we are extremely happy with the start. I think our teams have done an excellent job really executing this launch well in such an important area of medical need.

但我們對這個開局非常滿意。我認為團隊在這個極其重要的醫療需求領域，確實把上市執行得非常出色。

And, Joe, this is Renee. I'll jump in on BD. So we are highly engaged on the BD front, and I do expect us to have deals announced over the course of this year. We do have a clear strategy that is focused on expanding our presence in rare disease. In particular, we believe there is a significant unmet need. So strengthening our current areas of epilepsy, sleep, and rare oncology, also expanding into new areas of rare disease, areas we think we can leverage our capabilities and our footprint to continue to scale our business while driving further growth and profitability.

Joe，我是 Renee。我來補充 BD（商務開發）。我們在 BD 方面高度投入，我也預期今年期間會宣布一些交易。我們有明確策略，聚焦於擴大我們在罕見疾病的布局。特別是，我們認為仍存在顯著未被滿足需求。因此，我們會強化目前在癲癇、睡眠與罕見腫瘤的既有領域，同時也擴展到新的罕見疾病領域；這些是我們認為可以運用自身能力與既有布局（footprint），在推動進一步成長與獲利的同時，持續擴大業務規模的方向。

In terms of the deal types, it really depends on the asset and the transaction at hand, but we are looking at licensing, structured deals, also outright M&A. I think the key here to being successful in BD is identifying value or risks that others do not see and then staying myopically focused on execution, as we did with the Chimerix launch -- Chimerix acquisition and subsequent Modeyso launch.

至於交易類型，會視資產與具體交易而定；我們正在評估授權、結構式交易，也包括直接併購（outright M&A）。我認為 BD 成功的關鍵在於，辨識出他人看不到的價值或風險，然後像我們在 Chimerix 上市——Chimerix 收購以及後續 Modeyso 上市——那樣，極度專注於執行。

And we have very strong momentum now with the new CBO, Chief Business Officer, on board as of January 1. Importantly, we are well positioned to execute. Phil mentioned we have a strong financial position: $2.9 billion in cash and cash equivalents on the balance sheet, strong cash flow. And while M&A has picked up, we do believe there is still a lot of substrate that is actionable and well aligned with our strategic priorities.

而且我們目前在動能上也非常強，新任 CBO（首席商務長）已於 1 月 1 日到任。重要的是，我們具備良好執行條件。Phil 提到我們財務狀況強勁：資產負債表上有 29 億美元的現金與約當現金，現金流也很強。雖然併購活動升溫，但我們仍相信有大量可執行的機會，且與我們的策略優先事項高度一致。

Leo Timashev, RBC.

Leo Timashev，RBC。

I wanted to stay with -- you mentioned epilepsy. I just wanted to touch on that. You have been making a lot of investments in that area, both with Epidiolex, (inaudible) you also have JZP-047, and now you mentioned potentially looking at BD there as well. So I guess I'm just curious how you are thinking about that area, to what extent a continued focus, and how you are thinking about either synergies or risk of cannibalization across so many different assets there? Thanks.

我想延續——你們提到癲癇。我想稍微談一下這部分。你們在該領域投入很多，不論是 Epidiolex、（聽不清楚），你們也有 JZP-047，現在又提到可能也會在那裡做 BD。我想了解你們如何看待這個領域：會在多大程度上持續聚焦？以及在這麼多不同資產之間，你們如何看待協同效益或彼此蠶食（cannibalization）的風險？謝謝。

Yeah. Thanks for the question. I would say this is definitely an area of focus for us. There continues to be significant unmet need across the epilepsy space. You see a strong amount of polypharmacy here with respect to multiple medications generally on board, in particular when we are looking at serious refractory epilepsies.

好的，謝謝你的問題。我會說這絕對是我們的聚焦領域之一。癲癇領域仍存在顯著未被滿足需求。你會看到在這裡多重用藥（polypharmacy）的情況很普遍，也就是通常會同時使用多種藥物，特別是在我們關注嚴重的難治型癲癇時更是如此。

We think with the position that we have with Epidiolex being the number one branded product and having very long durability out to the very late 2030s, it gives us greater opportunity to continue to build around that franchise, to build scale. I'm thrilled to see additional opportunities for patients with the strong data that we have been seeing come out with a number of companies in -- whether that is on the proof-of-concept side starting to go into registrational studies or work that's happening early in pipelines.

我們認為，憑藉Epidiolex作為排名第一的品牌產品，且其專利/市場獨占的耐久性可延續至2030年代末期，這讓我們有更大的機會持續圍繞該產品線打造版圖、擴大規模。我很高興看到，基於我們所看到的強勁數據，來自多家公司在患者端出現更多機會——無論是概念驗證（proof-of-concept）階段開始推進至註冊性研究，或是管線早期正在進行的工作。

As we think about ourselves, we think there is plenty of room and unmet need for patients to continue to see new mechanisms explored and new options for patients. So we do think there is still plenty of substrate and a great opportunity for us as a leader in epilepsy. You will note last quarter, we said we were advancing the first molecule coming out of our labs that was not just a formulation play, but an innovative target, novel mechanism coming out of our lab that went into patients in the epilepsy space. So we will continue to invest here, and we're excited about the opportunities.

就我們自身而言，我們認為仍有很大的空間與未被滿足的需求，讓患者能持續看到新機轉被探索、以及新的治療選項。因此，我們確實認為仍有充足的基礎與很好的機會，使我們作為癲癇領域的領導者持續前進。你會注意到，上個季度我們提到，我們正在推進第一個出自我們實驗室的分子——它不僅僅是劑型改良，而是具創新標的、全新作用機轉的分子——並已在癲癇領域進入患者試驗。因此我們將持續在此投入，也對相關機會感到振奮。

Annabel Samimy, Stifel.

Annabel Samimy，Stifel。

Just want to circle up on Modeyso again. Obviously, it has been exceedingly promising since the outset, and you have potential to move into first-line treatment. I guess my question is how should we think about the potential move into first-line treatment? Does it significantly expand the market? Should we think about this like we think about Zepzelca moving into first line and how it significantly inflected growth?

我想再回到Modeyso這個話題。顯然，自一開始它就非常有前景，而且你們有可能推進到一線治療。我想問的是，我們應該如何看待它可能進入一線治療的意義？這是否會顯著擴大市場？我們是否應該把它類比為Zepzelca進入一線後、如何顯著帶動成長的那種情況？

I guess I'm trying to understand the magnitude given that most patients who are in first-line progress to second-line. Is it only about duration? Or is there a population opportunity there?

我想理解其量級，因為大多數一線患者會進展到二線。這只是治療持續時間（duration）的問題嗎？還是存在某個族群的機會？

Yes. Hi, Annabel. I'm happy to take that. Yes, I think there's two factors when we consider the action study and what that will do for Modeyso and for improving the treatment for patients. Some patients don't make it to second-line, so of course there are more patients available to be treated. But having the opportunity to get Modeyso to patients before they progress will mean that the duration of treatment should be longer if they can use it straight after radiation.

是的。嗨，Annabel。我很樂意回答。是的，我認為在我們考量ACTION研究及其將為Modeyso、以及改善患者治療所帶來的影響時，有兩個因素。有些患者無法走到二線治療，因此當然會有更多患者可被治療。但若能在患者進展之前就讓他們使用Modeyso，意味著如果他們能在放射治療後立即使用，治療持續時間應該會更長。

So those two things I think will contribute to us achieving the $500 million peak potential, which does incorporate an assumption that we will have that first-line label. Rob, anything more to add on that?

因此，我認為這兩點將有助於我們達成5億美元的峰值潛力，而這其中確實納入了我們將取得一線適應症標籤（first-line label）的假設。Rob，你還有什麼要補充的嗎？

I mean, you covered it well. I would just point out that sometimes it is hard to judge progression in these patients. And then, as you point out, once it is clinically apparent in addition to imaging, the patients may rapidly progress and not benefit from second-line therapy. So the opportunity to start Modeyso right after the radiation therapy really does potentially add a significant benefit to patients and ultimately duration of therapy.

我的意思是，你已經說得很完整了。我只想指出，有時候很難判斷這些患者的疾病進展。而且如你所說，一旦在影像之外也出現臨床上明顯的進展，患者可能會快速惡化，因而無法從二線治療中獲益。因此，在放射治療後立即開始使用Modeyso，確實可能為患者帶來顯著益處，並最終延長治療持續時間。

Marc Goodman, Leerink.

Marc Goodman，Leerink。

Sam, can you talk about Epidiolex OUS? I heard Phil talk about the FX impact, but those numbers couldn't have just been FX. Something is doing pretty well there. So maybe just talk.

Sam，你能談談Epidiolex在美國以外（OUS）的表現嗎？我聽Phil提到匯率（FX）影響，但那些數字不可能只是匯率因素。那邊一定有些事情做得很好。請你談談。

Was there any particular country? Was there any buy-in? Anything unusual there? And maybe you could just comment on RYLAZE as well, which happened to have a really good quarter. And what was happening there? Thanks.

是否有任何特定國家？是否有任何採購/導入（buy-in）？有什麼不尋常的因素嗎？另外也請你評論一下RYLAZE，它這一季表現也非常好。那邊發生了什麼？謝謝。

Yes. Thanks for the question, Marc. Yes, it's great to see the performance outside of the US for Epidiolex. Very strong growth indeed. Around about two-thirds of that, I believe, was volume, and there was about a third due to FX and some gross-to-net benefits from places like the UK with a VPAG adjustment that happened there.

是的，謝謝你的問題，Marc。是的，很高興看到Epidiolex在美國以外市場的表現，確實成長非常強勁。我相信其中大約三分之二來自銷量（volume），約三分之一來自匯率（FX），以及像英國等市場因VPAG調整而帶來的一些毛到淨（gross-to-net）效益。

And I think this is just down to terrific execution by our teams. As you know, Epidiolex was launched a little bit later in Europe, so there's still quite some opportunity to continue to penetrate in the Pediatric segment, but, of course, also in the Adult segment, which is a focus for both US and the ex-US business.

我認為這主要歸功於我們團隊出色的執行力。如你所知，Epidiolex在歐洲上市時間稍晚，因此在兒科（Pediatric）族群仍有相當大的滲透空間；當然，在成人（Adult）族群也同樣有機會，而這也是美國與美國以外業務共同的重點。

And then your other question around RYLAZE. Yes, RYLAZE -- RYLAZE, yeah?

然後你另一個關於RYLAZE的問題。是的，RYLAZE——RYLAZE，對嗎？

Yep.

對。

RYLAZE delivered a strong quarter, $100 million, which was 10% revenue growth. But that was comparing to quite a low Q1 '25. So I think the performance that we have seen in this quarter is in line with the prior quarters that we have seen, other than the Q1 which is a low point.

RYLAZE本季表現強勁，達到1億美元，營收成長10%。但這是相較於2025年第一季相當低的基期。因此，我認為本季看到的表現，除了第一季是低點之外，整體上與我們先前幾季所見的水準一致。

What we've seen with RYLAZE is the COG impact that started in '24 has been fully realized now. And our focus continues to be on making sure that appropriate patients can receive RYLAZE, that they are switched at the first sign of a hypersensitivity reaction, and the opportunity to continue growth in AYA. But I think that $100 million per quarter for RYLAZE is a good kind of stable base for us currently.

我們在RYLAZE上看到的是，始於2024年的銷貨成本（COG）影響現在已完全反映。我們的重點仍是確保適合的患者能使用RYLAZE、在出現過敏反應（hypersensitivity reaction）的第一個跡象時就完成轉換，以及在青少年與年輕成人（AYA）族群持續成長的機會。不過我認為，目前每季1億美元的RYLAZE營收，對我們而言是一個不錯且相對穩定的基礎。

Etzer Darout, Barclays.

Etzer Darout，Barclays。

Hi. This is Jordan Becker on for Etzer Darout. Thanks for taking my question and congrats on the impressive quarter. Maybe just one, if we could expand on any second-half dynamics for oxybates now with a full quarter in the rearview. Maybe if you could provide some more color on any potential competitive pressure from Lumryz specifically. And then on that, maybe any perceived pressure to IH growth down the line if Lumryz is approved in IH?

嗨，我是代Etzer Darout提問的Jordan Becker。謝謝你們回答我的問題，也恭喜這一季表現亮眼。想請教一點：現在已經有完整一季的數據，是否能延伸談談今年下半年對oxybates的動態？也許能多提供一些關於Lumryz可能帶來的競爭壓力的看法。以及延伸來看，如果Lumryz在IH獲批，是否會對未來IH的成長造成任何你們感受到的壓力？

Yes, I am happy to take that question on Xywav. We are very pleased with the continued momentum for Xywav. $408 million this quarter, 18% revenue growth and a really healthy 12% volume growth. We continue to see really good patient adds: 425 net patient adds in the quarter, most of them continuing to come from IH 300 net patient adds for IH, which is consistent with what we've seen in prior quarters.

是的，我很樂意就Xywav回答這個問題。我們對Xywav持續的動能感到非常滿意。本季4.08億美元，營收成長18%，且銷量成長達到健康的12%。我們持續看到非常好的新增患者：本季淨新增425名患者，其中大多數仍來自IH——IH淨新增300名患者——這與我們前幾季看到的情況一致。

So we finished the quarter with 16,600 active patients. And when we look ahead to the outlook for Xywav for the remainder of the year, obviously, we're very pleased with the momentum that we are taking into the second quarter. We still have continued strong payer coverage, more than 90% of commercial lives covered. Nothing has changed around the nature of our Xywav business in the first quarter of this year. And our 2026 full-year guidance does include assumptions that generics will build volumes in the second half of the year, as well as the potential for the entry of new wake-promoting agents entering the market in the second half of the year in the NT1 Narcolepsy segment.

因此本季結束時，我們有16,600名活躍患者。展望今年剩餘期間的Xywav前景，顯然我們對帶入第二季的動能非常滿意。我們仍維持強勁的支付方覆蓋，商業保險覆蓋的受保人群（commercial lives）超過90%。今年第一季我們Xywav業務的本質並沒有任何改變。而我們2026年全年指引確實納入了以下假設：學名藥（generics）將在下半年逐步建立銷量，以及在下半年於NT1嗜睡症（Narcolepsy）細分市場中，可能會有新的促醒藥物（wake-promoting agents）進入市場。

But we believe Xywav will continue to have a really important place in therapy. We have invested in some really meaningful evidence generation, XYLO and the DUET studies, which show the importance of having a low-sodium option, and as you mentioned, it's the only option approved for IH. And the DUET study, which shows just how effective Xywav is as a nighttime agent. And we believe those two benefits will continue to resonate strongly with physicians and patients, of course.

但我們相信Xywav仍將在治療中占有非常重要的位置。我們已投入一些非常有意義的證據生成（evidence generation），包括XYLO與DUET研究，顯示低鈉選項的重要性；而且如你所提到，它也是唯一獲批用於IH的選項。DUET研究也顯示Xywav作為夜間用藥（nighttime agent）的效果有多好。我們相信這兩項優勢將持續強烈地引起醫師與患者的共鳴。

Brian Skorney, Baird.

Brian Skorney，Baird。

This is Charlie on for Brian. I was just wondering if you could give us a sense of the size of the opportunity for Epidiolex in the adult and long-term care setting. And maybe some more color on the initiatives you're taking there with the new formulation, as well as would be curious to hear will you be sharing any data from the Phase 1b in focal-onset when you get that? And do you have any idea in terms of timing there as well as what your expectations are for the setting for Epidiolex? Thanks.

我是代Brian提問的Charlie。我想請問你們能否讓我們了解一下，Epidiolex在成人與長期照護（long-term care）場景中的機會規模？也希望你們能多談一些你們在那裡推動的新劑型相關措施。另外也想了解，當你們拿到局部發作（focal-onset）第一期b（Phase 1b）的數據時，是否會分享？以及你們對時間點是否有概念？還有你們對Epidiolex在該場景的預期是什麼？謝謝。

I'm happy to take the first part of your question in relation to the Adult segment, and then I'll hand over to Rob to talk about the study. We're very happy with the performance of Epidiolex in the first quarter of this year, $250 million, 15% revenue growth, and 16% volume growth. As you probably recall, Epidiolex was launched initially very much as a pediatric drug, and we've seen really good penetration in that segment, a leading agent, obviously, for pediatric patients.

我很樂意先回答你問題中與成人族群相關的第一部分，然後再交給Rob談研究。我們對Epidiolex在今年第一季的表現非常滿意：2.5億美元，營收成長15%，銷量成長16%。如你可能記得，Epidiolex最初上市時很大程度上被定位為兒科用藥，而我們在該族群已看到非常好的滲透率，顯然也是兒科患者的領先用藥。

One area that we do continue to see opportunities in is in that Adult segment, particularly in long-term care facilities. So we've made some specific investments there with a dedicated team focusing on those facilities. And we've also invested in a diagnostic tool, REST-LGS tool, because we know that adult patients with LGS often go undiagnosed. So we have supported physicians to help ensure that those patients can get a definitive diagnosis and benefit from Epidiolex.

我們確實持續看到機會的一個領域是在成人族群，特別是在長期照護機構。因此我們在那裡做了具體投資，成立專責團隊聚焦這些機構。我們也投資了一個診斷工具REST-LGS工具，因為我們知道患有LGS的成人患者常常未被診斷。我們因此支持醫師，協助確保這些患者能獲得明確診斷並受益於Epidiolex。

In addition to that, one of the hallmarks of Epidiolex is the very long persistency that we see. But we do see an opportunity to drive that even further. We know that patients that are enrolled onto our JazzCares program, which also gets the support of a Nurse Navigator. They do stay on treatment longer, so we have a particularly focused effort now on ensuring that as many patients as possible can benefit from our JazzCares suite of services, and we believe that will drive even longer durations of treatment for Epidiolex.

除此之外，Epidiolex 的一大特色是我們觀察到其治療持續性非常長。但我們也看到機會可以把這點再往前推進。我們知道，加入我們 JazzCares 計畫的患者（同時也會獲得護理導航員的支持）確實會在治療上維持更久，因此我們目前特別聚焦於確保盡可能多的患者能受益於我們 JazzCares 的一整套服務，我們相信這將推動 Epidiolex 的治療持續時間進一步延長。

In addition to that, we are making quite significant investments in evidence generation. We have the EpiCom study in TSC and the BECOME survey, which has been focused on adults, which really just underlines the benefit that Epidiolex has not just for the control of seizures, but also for controlling some of the non-seizure symptoms that these patients experience as well. And that's one of the very significant differentiating benefits of Epidiolex.

此外，我們也在證據生成方面進行相當可觀的投資。我們在 TSC 方面有 EpiCom 研究，以及聚焦成人族群的 BECOME 調查，這些都再次強調 Epidiolex 的效益不僅在於控制癲癇發作，也能幫助控制這些患者所經歷的一些非發作症狀。而這正是 Epidiolex 非常重要的差異化優勢之一。

So overall, we're very encouraged by the momentum that we have with Epidiolex but also really see a lot of long-term potential to continue to grow Epidiolex into the future, particularly in that Adult segment.

總體而言，我們對 Epidiolex 目前的動能感到非常鼓舞，同時也確實看到其長期持續成長的巨大潛力，特別是在成人市場區隔。

Thanks for the question on the focal-onset seizure study. We are super excited about it. There's a lot of interest from epileptologists to more formally evaluate Epidiolex in this setting.

謝謝你針對局灶性起始癲癇發作研究的提問。我們對此非常興奮。許多癲癇專科醫師都很有興趣在這個情境下更正式地評估 Epidiolex。

As you know, doctors and treaters think about epilepsy in terms of types of seizures, and we have lots of data showing activity of Epidiolex across really every type of seizure with some preliminary evidence in focal onset seizures as well. This is an evidence generation study to go deeper into this particular population, and we would intend to publish this as soon as we have data available to do so.

如你所知，醫師與治療者會以癲癇發作類型來思考癲癇，而我們有大量數據顯示 Epidiolex 幾乎對各類型發作都有活性，且在局灶性起始發作方面也有一些初步證據。這是一項證據生成研究，目的是在這個特定族群中做更深入的探討；一旦有可供發表的數據，我們會盡快發表。

We have not given any specifics on that yet. After a little more time elapses and we get a good sense of the enrollment rate, we may be able to update further.

我們目前尚未提供任何具體細節。再過一段時間，當我們對入組速度有更清楚的掌握後，或許能進一步更新。

David Amsellem, Piper Sandler.

David Amsellem，Piper Sandler。

So I have a long-term competitive landscape question on your oxybate business. So your competitor has Valiloxybate, the sodium once-nightly, or potential no-sodium once-nightly product that's in development. To the extent that it reaches the market, can you talk about how that could impact your Xywav business, both in terms of narcolepsy and the IH setting?

我有一個關於你們 oxybate 業務長期競爭格局的問題。你們的競爭對手有 Valiloxybate，這是一種每晚一次的含鈉產品，或可能是每晚一次的無鈉產品，正在開發中。若其最終上市，你們能否談談這可能如何影響你們的 Xywav 業務，包含嗜睡症與 IH 適應症？

And just in general, how are you planning to respond competitively to overall a more crowded landscape? The obvious is, of course, with the orexins, but also next-generation oxybate products as well. Thanks.

另外更一般性地，你們打算如何在整體更擁擠的競爭環境中應對？顯而易見的是 orexin 類藥物，但也包括下一代 oxybate 產品。謝謝。

Maybe I can step in on that, and then I'll ask Rob to comment on how we are viewing orexins. So I would first point to the fact that Xywav has been competing for the last two years with a number of high-sodium options on the market. And over that time, we have not only built a strong group of patients that are relatively persistent in terms of their use of oxybate, the specific relief and flexibility that they receive from Xywav, and also being the only product available for IH.

我可以先回應這個問題，然後再請 Rob 評論我們如何看待 orexin。首先我想指出，Xywav 在過去兩年一直與市場上多種高鈉選項競爭。在這段期間，我們不僅建立了一群在 oxybate 使用上相對具有持續性的患者，他們也從 Xywav 獲得特定的緩解與使用彈性，而且 Xywav 也是目前唯一可用於 IH 的產品。

We've done a lot of work in the market in terms of disease awareness. One of the areas that we've invested quite a lot in, that Sam has spoken to earlier, is the patient support services. I think that is highly differentiating for Jazz in terms of the extent of our services and the way that we have deployed those.

我們在市場端做了大量工作以提升疾病認知。我們投入相當多資源的一個領域（Sam 先前也提到）是患者支持服務。我認為這在 Jazz 的差異化上非常關鍵，因為我們服務的廣度以及落地執行的方式都很有區隔性。

And so we will continue to ensure that the unique differentiating benefits of Xywav, as well as various support services, are well understood in the market. I would also note that we do, from a patent perspective, have a lot of confidence in our overall patent estate. So when you're thinking about the various programs that are out there that may be for a 505(b)(2) sort of path, from that perspective, we do have robust patents that include many Orange Book–listed patents out to 2033 and '37, and then an Orange Book–listed IH patent out to 2041. But maybe I will also invite Rob to comment with respect to orexins coming into the market and our view there.

因此，我們會持續確保市場充分理解 Xywav 獨特的差異化優勢，以及各項支持服務。我也要補充，從專利角度來看，我們對整體專利組合非常有信心。所以當你在思考外部可能走 505(b)(2) 路徑的各種計畫時，從這個角度而言，我們擁有強健的專利，包括多項 Orange Book 登錄專利可延伸至 2033 年與 2037 年，另外還有一項 Orange Book 登錄的 IH 專利可延伸至 2041 年。不過我也想請 Rob 就 orexin 進入市場以及我們的看法補充說明。

Yeah. We've been following orexins carefully, and our conclusion is that it's likely to be complementary to Xywav. As Sam mentioned, alluding to the DUET study, we have significant data showing that the root cause in hypersomnia, such as narcolepsy type 1 and 2, as well as IH, has really disrupted nighttime sleep, and oxybates are the only therapy that can address the disrupted nighttime sleep directly. And Xywav, of course, is the only low-sodium formulation that we believe is safest for patients who are at a high risk for cardiovascular outcomes.

是的。我們一直密切追蹤 orexin，我們的結論是它很可能會與 Xywav 形成互補。如 Sam 提到並暗示 DUET 研究，我們有大量數據顯示，嗜睡症（如第 1 型與第 2 型嗜睡症）以及 IH 的根本原因其實是夜間睡眠受到嚴重干擾，而 oxybate 是唯一能直接處理夜間睡眠受干擾問題的療法。當然，Xywav 是唯一的低鈉配方，我們相信對於心血管事件高風險患者而言是最安全的。

Certainly, the orexins are showing to be potent daytime alerting agents. But some preliminary data are showing, though, that you can have insomnia, especially with the longer half-life formulations. And the limited PSG data that are out there suggest that certainly are not improving disrupted nighttime sleep and may actually, in the first half of the night, be impacting it negatively with the reports of insomnia.

確實，orexin 類藥物顯示出強效的日間促醒作用。但一些初步數據也顯示，尤其是半衰期較長的配方，可能會出現失眠。而目前有限的 PSG 數據顯示，它們當然沒有改善夜間睡眠受干擾的問題，甚至可能在前半夜因失眠回報而對睡眠造成負面影響。

So we continue to think that this is an important space to follow. We have an orexin in development still, and -- but we think, ultimately, this is going to be complementary to Xywav.

因此我們仍認為這是一個需要持續關注的重要領域。我們也仍有一個 orexin 藥物在開發中——但我們認為最終它將會與 Xywav 互補。

Mohit Bansal, Wells Fargo.

Mohit Bansal，Wells Fargo。

Great. Thank you very much for taking my question, and congrats on all the progress. Just want to ask about the Zepzelca IP here. I see a few new Orange Book–listed patents here since 2025, so they go all the way to 2040. So how should we think about the life of Zepzelca beyond 2029 at the compound-of-matter patent at this point? Thank you.

很好。非常感謝讓我提問，也恭喜你們取得的所有進展。我想問一下 Zepzelca 的智慧財產權。我看到自 2025 年以來新增了幾項 Orange Book 登錄專利，最遠可到 2040 年。因此，就目前而言，在 2029 年的化合物本體（compound-of-matter）專利之後，我們應該如何看待 Zepzelca 的專利壽命？謝謝。

Yeah. Thanks, Mohit. This is Renee. So we do have a strong patent estate for Zepzelca, and as you noted, we have multiple patents that extend out to 2040. We're also pursuing multiple new patents with the Patent Office that would also extend out to that timeframe, with additional applications, whether that be combo therapies, formulations, or methods of treatment.

是的，謝謝你，Mohit。我是 Renee。Zepzelca 的專利組合確實很強，如你所指出，我們有多項專利可延伸至 2040 年。我們也正在向專利局申請多項新專利，同樣可延伸至該時間範圍，並且還有其他申請，可能涵蓋聯合療法、劑型/配方或治療方法等。

We have also -- stepping back and speaking to the ANDA filers that we've disclosed, we have filed suit against all five ANDA filers, and as the result of filing that suit, a stay of approval is in effect for up to 30 months as imposed by the FDA.

另外——回到我們已披露的 ANDA 申請者，我們已對所有五家 ANDA 申請者提起訴訟；由於提起訴訟，FDA 施加的核准暫緩（stay of approval）已生效，最長可達 30 個月。

And so while we are not going to speak broadly to active litigation, we do feel that we have a strong patent estate. And as we have more clarity and information on that, we will be certain to share that.

因此，雖然我們不會廣泛評論進行中的訴訟，但我們確實認為我們擁有強健的專利組合。隨著我們獲得更多明確性與資訊，我們一定會對外分享。

Jason Gerberry, Bank of America Securities.

Jason Gerberry，Bank of America Securities。

Just one Phil. On Xywav, -- I apologize if I missed this, but you, at the beginning of the year, guided to flat to mid-single-digit growth for Xywav. Given growth of nearly 20% in 1Q, just wondering if we should be assuming that we're coming in towards closer to the high end of that number? Or were there some one-time dynamics in the 1Q number to call out? And how should we think about zanidatamab pricing OUS and any MFN-related considerations? Thanks.

我只有一個問題，Phil。關於 Xywav——如果我漏聽了先說聲抱歉——你們在年初指引 Xywav 為持平到中個位數成長。鑑於第一季成長接近 20%，我想確認我們是否應該假設結果會更接近該區間的高端？還是第一季數字中有一些一次性因素需要特別指出？另外，zanidatamab 在美國以外（OUS）的定價，以及任何與 MFN 相關的考量，我們應該如何看待？謝謝。

Sure. Thanks for the question, Jason. On Xywav in the US, really pleased, as Sam mentioned, with the great execution of our field-based team. In terms of underlying growth, we had volume growth of about 12% here in the first quarter. There was a bit of additional pickup coming from net price, primarily gross-to-net favorability with both mix of business and then patients successfully transitioning more quickly than in the past back onto their insurance in that first quarter reauthorization period.

好的。謝謝你的問題，Jason。關於美國的 Xywav，如 Sam 所提，我們對外勤團隊出色的執行非常滿意。就基本面成長而言，我們第一季的量（volume）成長約 12%。另外還有一些額外提升來自淨價格（net price），主要是總價到淨價（gross-to-net）的有利變動，原因包括業務組合（mix of business），以及患者在第一季重新授權（reauthorization）期間，比過去更快成功轉回其保險給付。

So that is something that is more of a first-quarter phenomenon. We would not expect to see that kind of net price pickup quarter on quarter as we get into Q2 through Q4, but definitely pleased with Xywav performance in the first quarter. It sets us up nicely for achieving the full-year guidance. I think that also applies to the total revenue guidance as well, not just Xywav.

因此，這比較屬於第一季的現象。我們不預期在進入第二季到第四季後，淨價格會在季度之間持續出現那樣的提升；但我們確實對第一季 Xywav 的表現感到滿意。這讓我們很有利於達成全年指引。我認為這也同樣適用於總營收指引，而不僅僅是 Xywav。

And then for the MFN, zani, right now, the MFN considerations are a bit uncertain. We have got some sort of conflicting input out there; certainly GLP and GARD are as proposed to use a basket of ex-US countries to provide reference pricing for the US.

接著談到 MFN、zani（zanidatamab），目前 MFN 相關考量有些不確定。我們收到一些相互矛盾的訊息；可以確定的是，GLP 和 GARD 如先前所提，擬採用一籃子非美國國家作為美國的參考定價依據。

We'll certainly be taking that into account as we look at the strategy for getting Ziihera to patients outside of the US, which is certainly a priority of ours and one that we will need to take account of the current situation here in the US as we move forward.

我們在制定讓 Ziihera 觸及美國以外患者的策略時，肯定會把這點納入考量；這一直是我們的優先事項。隨著我們往前推進，也必須把美國目前的情勢納入考量。

Not sure, Sam, if you would like to add any of your thoughts from a commercial perspective, or Renee more from a corporate strategic perspective.

不確定 Sam 你是否想從商業角度補充一些看法，或是 Renee 從公司策略角度補充。

Yeah. I think you've covered it nicely, Phil.

是的。我覺得你已經說得很完整了，Phil。

Okay, great. Lisa, next caller, please.

好的，很好。Lisa，請下一位來電。

Ami Fadia, Needham & Company.

Ami Fadia，Needham & Company。

I had a follow-up on the comments related to the oxybate franchise, particularly Xywav. I think at the beginning of the year, you talked about anticipating the potential for some additional headwinds either on the pricing side or just in terms of access with the entry of generics. Maybe if you could talk about some of the dynamics around whether you see any pushback on the use of Xywav, particularly in narcolepsy, and how you see the utilization in narcolepsy evolve with more generics on the market?

我想追問一下關於 oxybate 產品線、特別是 Xywav 的評論。我記得年初你們提到，隨著學名藥進入市場，可能在定價端或可近性方面會出現一些額外逆風。能否談談你們是否看到對 Xywav 使用上的任何反彈，特別是在嗜睡症（narcolepsy）方面？以及隨著更多學名藥上市，你們如何看待嗜睡症領域的使用量（utilization）演變？

And then just on the Modeyso ACTION trial, can you talk about which interim OS analysis will be done by the time you have the data readout in late 2026, early 2027, and your confidence around the timeline of that readout? Thank you.

另外關於 Modeyso 的 ACTION 試驗，能否說明在你們於 2026 年底、2027 年初取得數據讀出（readout）之前，會完成哪一個期中整體存活期（OS）分析？以及你們對該讀出時程的信心如何？謝謝。

I am happy to take the question relating to Xywav. Yes, of course, we've seen two multisource generics enter the market in Q1. As yet, we have not seen any impact on Xywav's business so far. As I mentioned previously, we continue to have strong payer coverage supporting the use of Xywav, so nothing really has changed in the nature of our business for Xywav.

我很樂意回答與 Xywav 相關的問題。是的，當然，我們在第一季看到兩個多來源（multisource）的學名藥進入市場。到目前為止，我們尚未看到對 Xywav 業務造成任何影響。如我先前提到的，我們仍持續獲得強勁的保險給付方（payer）覆蓋來支持 Xywav 的使用，因此 Xywav 的業務本質並沒有真正改變。

But, of course, it is still early days for the generics in the market. We do anticipate that as their volume grows through the course of the year, then we may start to see some actions taken by payers that may include utilization management. We do not know yet. But we're very confident that Xywav offers a really important and differentiating option for patients: being the only low-sodium option, the only product approved for IH.

但當然，學名藥進入市場仍屬早期。我們預期，隨著其在今年內逐步放量，保險給付方可能會開始採取一些措施，可能包括用藥使用管理（utilization management）。目前我們還不確定。不過我們非常有信心，Xywav 為患者提供了非常重要且具差異化的選擇：它是唯一的低鈉選項，也是唯一獲核准用於 IH 的產品。

And, of course, it has already demonstrated how effective it is as a nighttime agent and the impact that has on daytime symptoms. So we've obviously carried strong momentum throughout the last twelve months and into this year, and we're in a strong position as we go into Q2.

而且它已經證明作為夜間用藥的有效性，以及對日間症狀的改善影響。因此，過去 12 個月我們維持了強勁動能並延續到今年；進入第二季時，我們也處於有利位置。

Maybe I'll hand over to Rob for the question on Modeyso.

關於 Modeyso 的問題，我想交給 Rob 來回答。

Rob -- I'll go ahead, Sam, and just add one thing real quickly as we think about what we're seeing with Xywav before we go on to Rob for Modeyso. Certainly the dynamics are a bit unusual in the first quarter given reauthorization, but I do think we're seeing continued support by patients and physicians of the unique benefit that Xywav offers. From looking at the net patient adds, I think Lumryz net patient adds were announced roughly 100 adds this quarter, like the 100 last quarter.

Rob——在轉給 Rob 談 Modeyso 之前，Sam，我先很快補充一點，談談我們對 Xywav 目前觀察到的情況。第一季的動態確實有點不尋常，因為涉及重新授權（reauthorization），但我認為我們看到患者與醫師仍持續支持 Xywav 所提供的獨特效益。從淨新增患者數（net patient adds）來看，我記得 Lumryz 本季公布的淨新增大約是 100 人，和上季差不多也是 100 人。

Our numbers just in narcolepsy have been larger than that in each of those two quarters. Again, I think underscoring this unique benefit that only Xywav can offer and the safety advantage it confers being valued by patients as well as physicians. So we're in a great, great position from that perspective as well as we think about the back part of the year and how things could play out. Rob?

而我們僅在嗜睡症領域的數字，在這兩個季度都比那更高。再次強調，這凸顯只有 Xywav 能提供的獨特效益，以及其帶來的安全性優勢，正受到患者與醫師的重視。因此，從這個角度來看，當我們思考今年下半年以及情勢可能如何發展時，我們也處於非常、非常有利的位置。Rob？

Yeah. So, I mean, the ACTION trial is an OS-based endpoint and there's one interim analysis and then a final analysis. The projections we gave are based on our current understanding of the events because it is an event-driven trial. And certainly, if the events slow over time, that could change. But we will update as appropriate as time goes on.

好的。ACTION 試驗的終點是以整體存活期（OS）為基礎，會有一次期中分析，然後是最終分析。我們給出的預估是基於目前對事件數（events）的理解，因為這是一項事件驅動（event-driven）的試驗。當然，如果事件發生速度隨時間放緩，時程可能會改變。但我們會隨著時間推進在適當時點更新。

David Hoang, Deutsche Bank.

David Hoang，德意志銀行（Deutsche Bank）。

I first wanted to ask on the timing of a potential NCCN Guideline incorporation for zani in GEA. Do you have any sense of, relatively, when that might occur versus the PDUFA date, and how important is a category 1 recommendation to drive uptake?

我首先想問的是，zani 在 GEA 的 NCCN 指南可能納入的時點。你們是否大致掌握它相對於 PDUFA 日期可能何時發生？以及要推動採用（uptake），第 1 類（category 1）推薦的重要性有多高？

And then in breast cancer for zani, I wanted to get a sense of how you're thinking about the opportunity size in the different settings. So obviously, you're looking at post-Enhertu, but I think you're also looking at neoadjuvant/adjuvant. I was just curious as to your thoughts on the size of the opportunity in those various settings.

另外在乳癌方面的 zani，我想了解你們如何看待不同治療情境下的機會規模。很明顯你們在看 Enhertu 之後（post-Enhertu）的情境，但我想你們也在看新輔助/輔助治療（neoadjuvant/adjuvant）。我想請教你們對這些不同情境下機會規模的看法。

Great. On the NCCN Guidelines, we proactively submitted the abstract data because it was available. We will certainly update NCCN with the full manuscript as soon as that's available, and we hope that gives them everything they need to make a prompt decision on that and adoption, which we expect.

好的。關於 NCCN 指南，我們在摘要數據可用時就主動提交了。我們也會在完整論文（full manuscript）一旦可用時立即更新給 NCCN；我們希望這能提供他們做出迅速決定與採納（adoption）所需的一切資料，而我們也預期會被採納。

Certainly, we think the data speak for themselves. Head to head against Herceptin, zanidatamab definitively wins. It's clear that tislelizumab is adding and is likely to be synergistic between zani and tislelizumab as demonstrated by the activity in the PD-L1 negative subset, supporting its use upfront with tislelizumab. And so we think those data speak for themselves, and that should be reflected in NCCN.

我們確實認為數據本身已經說明一切。與 Herceptin 正面對比（head to head），zanidatamab 明確勝出。也很清楚 tislelizumab 帶來額外效益，且 zani 與 tislelizumab 之間很可能具有協同作用；這點也由 PD-L1 陰性亞組的活性所證實，支持其與 tislelizumab 於一線（upfront）合併使用。因此我們認為這些數據不言自明，也應反映在 NCCN 中。

Sorry, just to finish off the remainder of that question there. NCCN Guidelines inclusion is obviously important. We think that the data support a category 1 inclusion. If it comes before the launch, then that will open up access ahead of regulatory approval.

抱歉，我把這個問題剩下的部分補充完。NCCN 指南納入當然很重要。我們認為數據支持納入為第 1 類（category 1）。如果能在上市（launch）前就納入，將可在監管核准前先行打開可近性（access）。

Of course, we don't promote ahead of regulatory approval, but certainly, that will make it easier for physicians to provide access to their patients. And yes, the breast cancer opportunity is obviously very significant, significantly larger than either the BTC opportunity or the GEA opportunity, with many more patients that can potentially benefit from zanidatamab. So we're excited, obviously, about that for the long-term potential for Ziihera.

當然，我們不會在監管核准前進行推廣（promote），但這確實會讓醫師更容易為其患者提供用藥可近性。至於乳癌機會，顯然非常可觀，規模也遠大於 BTC 機會或 GEA 機會，因為有更多患者可能從 zanidatamab 中受益。因此我們對 Ziihera 的長期潛力感到非常振奮。

Thank you. And that does conclude today's Q&A session. I would like to turn the call over to Renee Gala, CEO, for closing remarks. Please go ahead.

謝謝。今天的問答環節到此結束。我想把電話交回給執行長 Renee Gala 作結語。請開始。

Thanks, operator. I'd like to close today's call by thanking all our partners and stakeholders for their continued confidence and support. We look forward to sharing further updates on the potential approval of zanidatamab and GEA and additional meaningful progress with you over the remainder of the year. So thank you for joining us and have a great day.

謝謝接線員。我想在今天的電話會議結束前，感謝所有合作夥伴與利害關係人持續的信任與支持。我們期待在今年剩餘時間與各位分享更多關於 zanidatamab 在 GEA 潛在核准的最新進展，以及其他具意義的進展。謝謝各位參與，祝大家有美好的一天。

This concludes today's program. Thank you all for joining. You may now disconnect.

今天的節目到此結束。感謝各位參與。您現在可以掛線。