Jazz Pharmaceuticals PLC (JAZZ) 2026 Q2 法說會逐字稿

Good day and thank you for standing by. Welcome to Jazz Pharmaceuticals' second-quarter 2026 earnings conference call. (Operator Instructions)

各位好，感謝您稍候。歡迎參加 Jazz Pharmaceuticals 2026 年第二季財報電話會議。(接線員指示)

I will now hand the conference over to your first speaker today, John Bluth, VP and Head of Investor Relations. Please go ahead.

現在我將把會議交給今天的第一位講者：投資人關係副總裁兼主管 John Bluth。請開始。

Thank you and good afternoon, everyone. Today, Jazz Pharmaceuticals reported its second-quarter 2026 financial results. The slide presentation accompanying this webcast is available on the Investor section of our website, along with the press release and quarterly report on Form 10-Q for the second quarter ended June 30, 2026. On the call today are Renee Galá, President and Chief Executive Officer; Sam Pearce, Chief Commercial Officer; Robert 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 年第二季財務業績。本次網路直播所搭配的簡報可於本公司網站「投資人」專區取得，並同時提供新聞稿以及截至 2026 年 6 月 30 日止第二季的 10-Q 季度報告。今天與會者包括：總裁暨執行長 Renee Galá；首席商務長 Sam Pearce；全球研發主管暨首席醫療長 Robert Iannone；以及財務長 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. We encourage you to review these risks and uncertainties described in today's press release 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 any forward-looking statements.

在第 2 張投影片，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；這些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所述之風險與不確定性，並參考我們截至 2025 年 12 月 31 日止會計年度的 10-K 年度報告中「風險因素」章節。我們不承擔更新任何前瞻性陳述之責任或義務。

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 Investor 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，均載於今日新聞稿與本公司網站「投資人」專區提供的簡報中。

Now I'd like to turn the call over to Renee.

現在我想把電話交給 Renee。

Thanks, John. Good afternoon, everyone, and thank you for joining today's conference call. We delivered another outstanding quarter, generating record revenue of $1.2 billion, representing 16% year-over-year growth. The momentum we've built in the first half of the year provides us with confidence to raise our full-year revenue guidance. Our results reflect an intense focus on aligned execution across our diversified portfolio, sustained demand for our commercial products, and progress in advancing our long-term priorities for value creation.

謝謝你，John。各位下午好，感謝參加今天的電話會議。我們再度交出亮眼的一季，創下 12 億美元的營收新高，年增 16%。我們在上半年累積的動能，使我們有信心上調全年營收指引。我們的成果反映出：對多元化產品組合的協同執行高度聚焦、商業化產品需求持續強勁，以及在推進長期價值創造優先事項方面的進展。

As we approach a significant milestone with the August 25 PDUFA date for zanidatamab in first-line HER2-positive metastatic GEA, our commercial, medical, and market access teams are fully prepared to successfully launch zanidatamab. We're entering a new phase of growth created by the opportunity to deliver clinically meaningful outcomes for patients facing this highly aggressive, difficult-to-treat disease. Our consistent execution reflects the focused strategy we outlined at the beginning of the year: expand our leadership in key therapeutic areas, advance differentiated innovation, and create durable long-term value.

隨著 zanidatamab 用於一線 HER2 陽性轉移性 GEA 的 8 月 25 日 PDUFA 日期即將到來這一重要里程碑，我們的商業、醫療與市場准入團隊已全面就緒，準備成功推出 zanidatamab。我們正進入新的成長階段，這源自於為面對此高度侵襲且難以治療疾病的患者帶來具臨床意義療效的機會。我們一貫的執行力體現了年初所提出的聚焦策略：擴大我們在關鍵治療領域的領導地位、推進具差異化的創新，並創造可持續的長期價值。

Across the business, our teams are delivering key therapies to patients, advancing zanidatamab, and leveraging our financial strength to invest in both internal R&D and external innovation. An example of this approach is our preclinical research collaboration with AbCellera, which leverages their T-cell engager platform to discover novel multispecific antibodies. This agreement directly complements our oncology expertise and supports our refined rare disease strategy. These exceptional results from the quarter position us to sustain our momentum while delivering meaningful benefits for patients and driving robust returns for our shareholders.

在整體業務方面，我們的團隊正將關鍵療法帶給患者、推進 zanidatamab，並運用我們的財務實力投資於內部研發與外部創新。此作法的一個例子是我們與 AbCellera 的臨床前研究合作，運用其 T 細胞接合器平台來發現新型多特異性抗體。此協議可直接補強我們的腫瘤學專長，並支持我們精煉後的罕見疾病策略。本季的卓越成果使我們得以延續動能，同時為患者帶來有意義的效益，並為股東創造強勁回報。

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

接下來我把電話交給 Sam，請他分享更多商業表現的細節。

Thank you, Renee. Our commercial teams delivered another impressive quarter of revenue, with 16% growth across the portfolio and double-digit growth from each of our key promoted brands. This performance is a result of focused investment and targeted, impactful execution, which is driving sustained momentum across our increasingly diversified portfolio. I'll begin on slide 7 with Rare Sleep.

謝謝你，Renee。我們的商業團隊再度交出令人印象深刻的一季營收表現，整體產品組合年增 16%，且每一個主要推廣品牌皆達到雙位數成長。此表現來自於聚焦投資與精準且具影響力的執行，推動我們日益多元化的產品組合持續累積動能。我將從第 7 張投影片的罕見睡眠（Rare Sleep）開始。

Xywav's profile as the only low-sodium oxybate on the market continues to resonate with physicians and patients. Xywav net product sales increased 13% to $471 million in the second quarter of 2026 compared to the second quarter of 2025. Supported by targeted healthcare provider and patient-focused digital campaigns, our field execution continues to expand the narcolepsy and idiopathic hypersomnia markets and deliver sustained new patient adds. These efforts emphasize Xywav's differentiated low-sodium profile and the efficacy it provides by treating underlying disrupted nighttime sleep and addressing daytime symptoms for patients living with narcolepsy and idiopathic hypersomnia. Demand for Xywav remains robust, with approximately 525 net patient additions in the quarter.

Xywav 作為市場上唯一的低鈉 oxybate，其產品特性持續獲得醫師與患者的認同。與 2025 年第二季相比，Xywav 於 2026 年第二季的淨產品銷售額成長 13% 至 4.71 億美元。在針對醫療照護提供者與以患者為中心的數位行銷活動支持下，我們的第一線執行持續擴大嗜睡症與特發性嗜睡症市場，並帶來穩定的新患者增加。這些努力強調 Xywav 具差異化的低鈉特性，以及其透過治療夜間睡眠受干擾的根本問題並改善白天症狀，為嗜睡症與特發性嗜睡症患者帶來的療效。Xywav 需求仍然強勁，本季約新增 525 名淨患者。

This brings our total active patients to approximately 17,125, representing more than 12% year-over-year growth. This momentum is supported by our targeted investments in high-touch patient support services such as our Field Nurse Educator program, which delivered differentiated support to help patients achieve optimal dosing and sustained treatment. This first half performance underscores the durability of our Sleep franchise with limited impact from high-sodium generics. Whilst we will closely monitor second half market dynamics, including generic availability and potential new product launches, our confidence in Xywav's foundational role is unwavering. Its clinical profile remains differentiated as the only low-sodium oxybate and the only FDA-approved option for IH patients.

這使我們的活躍患者總數達到約 17,125 人，年增超過 12%。此動能亦受益於我們對高接觸式患者支持服務的精準投資，例如我們的「外勤護理教育員」計畫，提供具差異化的支持，協助患者達到最佳劑量並維持持續治療。上半年表現凸顯我們睡眠事業群的韌性，受高鈉學名藥影響有限。儘管我們將密切監測下半年市場動態，包括學名藥供應情況與潛在新產品上市，我們對 Xywav 作為基礎性產品的信心絲毫不變。其臨床特性仍具差異化：既是唯一的低鈉 oxybate，也是唯一獲 FDA 核准用於 IH 患者的選項。

Moving to slide 8 and Epidiolex. Epidiolex delivered another outstanding quarter, with net product sales growing 16% year over year to $292 million, driven primarily by robust underlying demand. This momentum is fueled by our field team's ongoing success in educating HCPs and caregivers on Epidiolex's broad-spectrum efficacy and its meaningful beyond-seizure benefits for new and existing patients. Concurrently, we are actively expanding the Epidiolex franchise, while Rob will cover our clinical expansion into new treatment-resistant seizures. I want to highlight a critical life cycle initiative, our novel capsule formulation. Designed to unlock additional utilization within our approved indications, the capsule targets deeper penetration in certain segments of the adult patient population.

接著看第 8 張投影片與 Epidiolex。Epidiolex 再度交出亮眼的一季，淨產品銷售額年增 16% 至 2.92 億美元，主要由強勁的基本需求所帶動。此動能來自我們第一線團隊持續成功地向醫療照護提供者（HCP）與照護者宣導 Epidiolex 的廣譜療效，以及其對新舊患者皆具意義的「超越癲癇發作」之效益。同時，我們正積極擴大 Epidiolex 事業版圖，而 Rob 將說明我們在新的治療抗藥性癲癇發作領域的臨床擴展。我想特別強調一項關鍵的產品生命週期計畫：我們的新型膠囊劑型。該膠囊旨在於既有核准適應症內釋放更多使用量，目標是在成人患者族群的特定區隔中提高滲透率。

By offering this convenient alternative alongside our oral solution formulation, we aim to improve accessibility and compliance for adult patients while firmly reinforcing our long-term leadership in the anti-seizure market.

透過在口服溶液劑型之外提供此一便利替代方案，我們希望提升成人患者的可近性與用藥依從性，同時穩固強化我們在抗癲癇發作市場的長期領導地位。

Turning to our Oncology portfolio, we are extremely pleased with the ongoing launch of Ziihera in BTC, as shown on slide 9. In the second quarter of 2026, Ziihera generated $15 million in net product sales. Since launching in second-line BTC, we have rapidly established clinical leadership, achieving more than 50% of the addressable market. This is driven by deepening utilization in academic centers and expanding adoption across community settings, supported by highly consistent, positive, real-world prescriber experiences. Critically, our success in BTC serves as a powerful commercial foundation for our next major growth phase in GEA. Because there is significant direct overlap between existing BTC and GEA treating accounts, our commercial infrastructure is fully primed.

轉到我們的腫瘤產品組合，如第 9 張投影片所示，我們對 Ziihera 在 BTC 的持續上市推進感到非常滿意。在 2026 年第二季，Ziihera 創造了 1,500 萬美元的淨產品銷售額。自於 BTC 二線治療上市以來，我們迅速建立臨床領導地位，取得超過 50% 的可觸及市場。這主要由於在學術醫學中心的使用持續加深，並在社區醫療場域的採用擴大；同時也受益於處方醫師在真實世界中高度一致且正向的用藥經驗。關鍵在於，我們在 BTC 的成功為下一個主要成長階段（GEA）奠定了強而有力的商業基礎。由於現有 BTC 與 GEA 治療帳戶之間存在顯著的直接重疊，我們的商業基礎建設已完全就位。

On slide 10, you can see how our launch readiness framework is designed to drive rapid uptake. Our commercial footprint is highly optimized with over 90% target physician overlap, allowing our team to rapidly generate clinician excitement and demand. And this enthusiasm is rooted in zanidatamab's exceptional clinical data, specifically an unprecedented median overall survival exceeding two years, establishing it as the potential preferred backbone in HER2-positive GEA. To support immediate clinical adoption at launch, we've submitted this data to key oncology pathways, and we'll leverage our already established permanent J-code to minimize reimbursement barriers. Backed by our robust JazzCares patient support program, we are fully prepared to deliver seamless access to patients upon approval.

在第10張投影片上，您可以看到我們的上市準備框架如何被設計用來推動快速採用。我們的商業覆蓋版圖高度優化，目標醫師重疊率超過90%，使我們的團隊能迅速激發臨床醫師的興趣並帶動需求。而這份熱情源自zanidatamab卓越的臨床數據，特別是前所未有、超過兩年的整體存活期（OS）中位數，使其有望成為HER2陽性GEA的首選基礎治療（backbone）。為了在上市時支持立即的臨床採用，我們已將這些數據提交至關鍵腫瘤治療路徑（pathways），並將運用我們既有的永久J-code，以降低給付報銷障礙。在強大的JazzCares病患支持計畫支援下，我們已做好充分準備，在獲批後為病患提供順暢無縫的用藥可近性。

Turning to slide 11 and Modeyso. Modeyso generated $48 million, representing remarkable progress since our launch in August of last year. Driven by highly coordinated, disciplined execution, more than 600 patients have now been treated with Modeyso through the end of the second quarter. To sustain this upward trajectory, we initiated additional non-personal promotion and peer-to-peer speaker programs in the second quarter. These initiatives are designed to educate community-based physicians and expand our reach to ensure timely referral of patients to academic centers of excellence.

接著看第11張投影片與Modeyso。Modeyso創造了4,800萬美元營收，代表自去年8月上市以來取得顯著進展。在高度協同且嚴謹執行的推動下，截至第二季末，已有超過600名病患接受Modeyso治療。為了維持這一上升趨勢，我們在第二季啟動了額外的非面對面推廣（non-personal promotion）以及同儕對同儕（peer-to-peer）的講者計畫。這些措施旨在教育社區型醫師並擴大我們的觸及範圍，以確保病患能及時被轉介至卓越的學術醫療中心。

On the diagnostic front, while biomarker testing is already high in high-grade gliomas, we are actively working to establish reflexive testing across all gliomas. This systematic approach is critical to ensure every H3 K27M patient is identified early and referred to targeted care. To support this, updated NCCN guidelines now endorse liquid biopsy for the H3 K27M biomarker. This represents a major milestone that broadens diagnostic pathways, reduces patient risk, and accelerates time to treatment.

在診斷方面，雖然在高級別膠質瘤中生物標記檢測率已經很高，我們仍在積極推動於所有膠質瘤中建立反射性檢測（reflex testing）。這種系統化方法至關重要，可確保每位H3 K27M病患都能及早被辨識並轉介至標靶治療照護。為此，更新後的NCCN指引現已支持以液體活檢檢測H3 K27M生物標記。這是一項重要里程碑，可擴大診斷途徑、降低病患風險，並加速進入治療的時間。

Finally, Modeyso continues to benefit from robust, highly favorable payer coverage. Combined with our dedicated patient support services, we are exceptionally well positioned to maintain this strong commercial momentum.

最後，Modeyso持續受惠於強勁且非常有利的支付方（payer）給付覆蓋。結合我們專屬的病患支持服務，我們具備極佳條件在商業面持續維持這股強勁動能。

Moving to slide 12 and Zepzelca. We are very pleased with Zepzelca's performance this quarter, achieving $106 million in net product sales, a 42% year-over-year increase. This robust growth was driven by highly positive prescriber feedback and rapid adoption in the first-line maintenance setting, which more than offset the anticipated tapering of our historical second-line business. The strength of our IMforte trial data clearly demonstrates that Zepzelca's greatest clinical value is in early intervention in combination with a PD-L1 inhibitor in the first-line maintenance setting, a consensus recently reinforced by its elevation to a Category 1 listing in the NCCN guidelines. Because metastatic small cell lung cancer progresses so rapidly, reaching patients earlier in their journey is critical. Later, Rob will provide an update on the second-line indication.

接著看第12張投影片與Zepzelca。我們對本季Zepzelca的表現非常滿意，淨產品銷售額達1.06億美元，年增42%。這項強勁成長主要來自處方醫師非常正向的回饋，以及在第一線維持治療（first-line maintenance）情境中的快速採用，這些因素不僅抵銷了我們歷史第二線業務預期的逐步下滑，且帶來淨增長。IMforte試驗數據的強度清楚顯示，Zepzelca最大的臨床價值在於早期介入：於第一線維持治療中與PD-L1抑制劑合併使用；而這一共識近期也因其在NCCN指引中提升至第1類（Category 1）推薦而再次獲得強化。由於轉移性小細胞肺癌進展極快，讓病患在治療旅程更早期就能用到藥物至關重要。稍後Rob將就第二線適應症提供最新進展。

Overall, we are very pleased with the commercial performance across our portfolio in the second quarter, and we remain focused on sustaining this momentum throughout the remainder of the year.

整體而言，我們對第二季整體產品組合的商業表現非常滿意，並將持續專注於在今年剩餘期間維持這股動能。

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

接下來，我將把電話會議交給Rob，請他更新我們的研發管線進展。

Thanks, Sam. I'll start on slide 14. This is a very exciting time at Jazz, driven in part by the August 25 PDUFA date for zanidatamab. The Phase 3 HERIZON-GEA-01 trial results were recently published in The New England Journal of Medicine, further characterizing the efficacy and safety profile of zanidatamab in combination with chemotherapy, with and without the PD-1 inhibitor tislelizumab. Publication in The New England Journal of Medicine underscores the clinical significance of these results and, we believe, will support awareness and adoption of zanidatamab among oncologists treating GEA patients. We also presented subgroup data at ASCO confirming that the zani and tisle combination delivers a consistent survival benefit irrespective of PD-L1 tumor expression. A 26.4-month median overall survival was observed with the zanidatamab plus tislelizumab arm, which was more than seven months longer than the control arm with trastuzumab.

謝謝，Sam。我先從第14張投影片開始。對Jazz而言，這是一個非常令人振奮的時刻，其中一個推動因素是zanidatamab的PDUFA日期為8月25日。第3期HERIZON-GEA-01試驗結果近期已發表於《新英格蘭醫學雜誌》（The New England Journal of Medicine），進一步闡述zanidatamab合併化療、以及合併或不合併PD-1抑制劑tislelizumab時的療效與安全性特徵。能在《新英格蘭醫學雜誌》發表凸顯了這些結果的臨床重要性，我們相信這將提升治療GEA病患之腫瘤科醫師對zanidatamab的認知並促進採用。我們也在ASCO發表了亞組數據，確認zani與tisle的合併治療不論腫瘤PD-L1表現如何，皆能帶來一致的存活獲益。在zanidatamab加tislelizumab組別觀察到26.4個月的整體存活期中位數，較以trastuzumab為對照組長了超過7個月。

The benefit was seen for all HER2-positive patients, irrespective of tumor PD-L1 status, and represents a remarkable advance for this patient population. zanidatamab plus chemotherapy showed a clinically meaningful survival benefit with a median OS of more than two years and a strong trend towards statistical significance at the time of the first interim OS analysis. We look forward to the upcoming top-line results from the second interim OS analysis of this double arm, which are expected in 3Q '26.

這項獲益在所有HER2陽性病患中皆可見，不受腫瘤PD-L1狀態影響，對此病患族群而言是一項顯著進展。zanidatamab合併化療顯示具臨床意義的存活獲益，整體存活期（OS）中位數超過兩年，且在第一次OS期中分析時呈現強烈趨勢、接近統計顯著性。我們期待這個雙臂試驗第二次OS期中分析即將公布的主要結果，預計於2026年第三季（3Q '26）出爐。

In addition, we have submitted The New England Journal of Medicine manuscript for potential inclusion in the NCCN guidelines. Our belief in zanidatamab increases as it was recently granted Breakthrough Therapy designation for adults with previously treated locally advanced, unresectable, or metastatic HER2-positive colorectal cancer. We look forward to sharing more on our development plans for colorectal cancer in the near term.

此外，我們已將《新英格蘭醫學雜誌》的論文稿件提交，爭取納入NCCN指引。我們對zanidatamab的信心持續提升，因其近期獲授予突破性療法（Breakthrough Therapy）認定，適用於先前接受治療之局部晚期、不可切除或轉移性HER2陽性大腸直腸癌成人病患。我們期待在不久的將來分享更多關於大腸直腸癌的開發計畫。

Turning to slide 15. Our R&D programs remain focused on building the next generation of growth drivers through internal innovation and external partnerships. We are leveraging our deep expertise in rare epilepsies to broaden our pipeline and extend the potential benefits of EPIDIOLEX, also known as cannabidiol, to more patients with treatment-resistant seizures. We are initiating three new clinical trials, including a Phase 4 trial in adults with LGS, a Phase 3 trial assessing the anti-seizure efficacy in a broad group of developmental and epileptic encephalopathies, and a seamless Phase 2-3 trial that will explore the capsule formulation in juvenile myoclonic epilepsy. These new trials build on the Phase 1b trial in focal onset seizures that was initiated at the end of last year, and the Phase 1 trial of JZP047, a novel molecular entity discovered by Jazz being developed in absence epilepsy.

接著看第15張投影片。我們的研發計畫仍聚焦於透過內部創新與外部合作夥伴關係，打造下一代成長驅動力。我們正運用在罕見癲癇領域的深厚專業，擴展研發管線，並將EPIDIOLEX（亦稱cannabidiol，大麻二酚）對治療抗性癲癇發作病患的潛在效益延伸至更多族群。我們將啟動三項新的臨床試驗，包括：成人LGS的第4期試驗、評估廣泛發展性與癲癇性腦病（developmental and epileptic encephalopathies）族群之抗癲癇療效的第3期試驗，以及一項無縫銜接的第2-3期試驗，用以探索青少年肌陣攣性癲癇（juvenile myoclonic epilepsy）的膠囊劑型。這些新試驗建立在去年底啟動的局灶性起始癲癇發作（focal onset seizures）第1b期試驗，以及Jazz所發現、用於失神性癲癇（absence epilepsy）開發中的新分子實體JZP047第1期試驗之上。

In addition, we submitted an NDA to the FDA for a novel capsule formulation to broaden utilization of Epidiolex in currently approved indications of LGS, DS, and TSC to improve flexibility and provide a new administration option for patients.

此外，我們已向FDA提交一項新型膠囊劑型的NDA，以擴大Epidiolex在目前已核准適應症（LGS、DS與TSC）中的使用，提升用藥彈性，並為病患提供新的給藥選項。

Moving to oncology and Zepzelca. Based on the results of the LAGOON trial and in alignment with FDA, in 3Q '26, we will submit for FDA's review and subsequent action a labeling supplement to remove the second-line indication. The first-line maintenance indication will not be affected. Lastly, on Modeyso, our Phase 3 ACTION trial is progressing. Based on the latest estimate of event accrual, we now anticipate that the overall survival interim analysis will be in the first half of 2027. This trial is designed to confirm the benefit of Modeyso and support regulatory approval as a frontline therapy directly following radiation.

接著談腫瘤領域與Zepzelca。基於LAGOON試驗結果並與FDA保持一致，我們將於2026年第三季（3Q '26）向FDA提交供其審查並後續處置的標示補充申請（labeling supplement），以移除第二線適應症。第一線維持治療適應症不受影響。最後，關於Modeyso，我們的第3期ACTION試驗正在推進中。根據最新的事件累積（event accrual）估算，我們目前預期整體存活期（OS）期中分析將於2027年上半年進行。此試驗旨在確認Modeyso的療效並支持其作為放射治療後緊接使用的第一線治療之法規核准。

We are making meaningful progress across our pipeline and in-house R&D efforts, and we look forward to sharing more updates as our programs advance.

我們在研發管線與內部研發工作方面正取得具實質意義的進展，並期待隨著各項計畫推進，分享更多最新進度。

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

現在我把電話交給 Phil 進行財務更新。Phil？

Thanks, Rob. Before diving into the financials for the quarter, I'd like to underscore our consistent progress delivering on our rare disease strategy. Our Commercial organization is firing on all cylinders, and we're making targeted investments to continue our momentum. Our R&D organization is working with urgency to generate practice-changing clinical data, highlighted by the NEJM publication of the zani first-line GEA results, and speed new medicines to market while also expanding indications for existing medicines to benefit even more patients. And we're deploying capital in a disciplined manner to enhance our growth prospects, most recently with the AbCellera deal.

謝謝你，Rob。在深入說明本季財務之前，我想強調我們在落實罕見疾病策略方面持續取得進展。我們的商業團隊火力全開，並且我們正進行有針對性的投資以延續動能。我們的研發團隊以緊迫感推動能改變臨床實務的臨床數據產出，其中重點包括《新英格蘭醫學期刊》（NEJM）發表 zani 一線 GEA 結果；同時加速新藥上市，並擴大既有藥物的適應症，以造福更多病患。此外，我們以嚴謹自律的方式配置資本以提升成長前景，最近的例子就是與 AbCellera 的交易。

Turning to the financial results for the quarter, 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. The outstanding execution of our field-based teams was reflected in record quarterly revenue of $1.21 billion, an increase of 16% over the second quarter of 2025, driven by 32% growth in our Oncology portfolio, 13% growth in Xywav, and 16% growth in Epidiolex. Moving down the P&L, our non-GAAP adjusted gross margin declined slightly year on year due to higher sales of Zepzelca and Modeyso, which carry third-party royalties.

接著看本季財務結果，我先就投影片 17 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新聞稿與 10-Q。我們外勤團隊的卓越執行反映在創紀錄的單季營收 12.1 億美元，較 2025 年第二季成長 16%，主要由腫瘤產品組合成長 32%、Xywav 成長 13% 以及 Epidiolex 成長 16% 所帶動。往下看損益表，我們的非 GAAP 調整後毛利率年對年小幅下滑，原因是 Zepzelca 與 Modeyso 的銷售占比提高，而這兩項產品需支付第三方權利金。

Non-GAAP adjusted SG&A and R&D expenses both grew 11%, with the increase in SG&A driven by higher expenses for Modeyso and Ziihera first-line GEA and, to a lesser extent, by investments in key commercial capabilities and digital and AI, while the increase in R&D was driven by higher expenses related to clinical trial costs, primarily related to zanidatamab. Our non-GAAP adjusted effective tax rate this quarter was moderately higher than our full-year 2026 guidance due to shifts in the expected geographic mix of income and expenses, while our shares outstanding for the quarter reflect the accounting effect of our higher share price on our convertible notes and employee stock plans.

非 GAAP 調整後的銷售、一般及行政（SG&A）與研發（R&D）費用皆成長 11%。其中，SG&A 的增加主要來自 Modeyso 與 Ziihera 一線 GEA 的較高費用，並在較小程度上來自對關鍵商業能力以及數位與 AI 的投資；而 R&D 的增加則來自與臨床試驗成本相關的較高費用，主要與 zanidatamab 有關。本季非 GAAP 調整後有效稅率略高於我們 2026 全年指引，原因是預期收入與費用的地理分布組合出現變化；同時，本季流通在外股數反映了股價上升對可轉換公司債與員工股票計畫所造成的會計影響。

At the bottom line, we posted very robust non-GAAP adjusted EPS of $5.71 which included IPR&D charges totaling $0.94. Beyond the income statement, I'd highlight that we generated operating cash flow of $824 million in the first half of the year, and during the second quarter, we paid off our 2026 convertible notes. With our strong financial position, we're able to continue to invest in our currently marketed products and our existing pipeline, as well as in Corporate Development.

在最終獲利方面，我們繳出非常強勁的非 GAAP 調整後每股盈餘（EPS）5.71 美元，其中包含合計 0.94 美元的 IPR&D 費用。除了損益表之外，我要特別指出我們在上半年產生了 8.24 億美元的營運現金流；並且在第二季，我們已償還 2026 年到期的可轉換公司債。憑藉我們強健的財務狀況，我們得以持續投資於目前已上市產品與既有研發管線，同時也投入企業發展（Corporate Development）。

Turning to slide 18 and our 2026 financial guidance. I'll focus my comments on those guidance elements that have changed since our last earnings call. We now expect total revenues in the range of $4.60 billion to $4.75 billion. This significant upward revision is largely driven by the outstanding execution of our Xywav field teams, driving home the unique benefits Xywav offers as the only low-sodium oxybate. To date, uptake of high-sodium generics has been quite limited, and we continue to post strong net patient adds.

接著看投影片 18 與我們的 2026 年財務指引。我將把重點放在自上次法說會以來已變動的指引項目。我們目前預期總營收介於 46.0 億至 47.5 億美元。這項大幅上修主要由我們 Xywav 外勤團隊的卓越執行所驅動，成功傳達 Xywav 作為唯一低鈉 oxybate 的獨特效益。截至目前，高鈉學名藥的採用相當有限，而我們仍持續繳出強勁的淨新增病患數。

We now anticipate double-digit growth for Xywav in 2026 and Rare Sleep revenue of between $2.025 billion and $2.125 billion. Strong first-half results of our Rare Oncology and Epilepsy portfolio further support our revised total revenue guidance range. On the expense side, we've modestly increased our SG&A expense guidance. This reflects deliberate strategic investments to build upon momentum in Xywav and Epidiolex, as well as to drive implementation of our rare disease strategy and our Corporate Development efforts.

我們目前預期 Xywav 在 2026 年將呈現雙位數成長，罕見睡眠（Rare Sleep）營收介於 20.25 億至 21.25 億美元。我們罕見腫瘤與癲癇產品組合在上半年的強勁表現，也進一步支持我們修訂後的總營收指引區間。在費用方面，我們小幅上調 SG&A 費用指引。這反映我們有意識的策略性投資，以延續 Xywav 與 Epidiolex 的動能，並推動罕見疾病策略的落地以及企業發展工作。

Finally, our updated share count guidance is 69 million to 70 million shares, reflecting the increase in our stock price since our last earnings call and its accounting effect on our convertible notes and employee stock compensation plans.

最後，我們更新後的股數指引為 6,900 萬至 7,000 萬股，反映自上次法說會以來股價上升，以及其對可轉換公司債與員工股票薪酬計畫所造成的會計影響。

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

現在我把電話交回給 Renee 作結語。

Thank you, Phil. I'll conclude our prepared remarks on slide 20. Our second-quarter results demonstrated the strength and continued diversification of our product portfolio, delivering record quarterly revenue, including a 32% increase from our Oncology products compared to 2Q '25, and consistent execution across our commercial and R&D pipeline. Importantly, we enter the second half of the year with significant momentum, highlighted by the anticipated zanidatamab approval and launch in GEA and multiple upcoming clinical readouts. Building on our proven scientific capabilities and strong financial position, we are making a meaningful impact for patients.

謝謝你，Phil。我將在投影片 20 結束我們事先準備的發言。我們第二季的結果展現了產品組合的實力與持續多元化，帶來創紀錄的單季營收，其中腫瘤產品相較於 2025 年第二季成長 32%，並且在商業執行與研發管線推進方面均維持一致的執行力。重要的是，我們帶著顯著動能進入下半年，亮點包括預期 zanidatamab 在 GEA 的核准與上市，以及多項即將公布的臨床讀出。憑藉我們經驗證的科學能力與強健的財務狀況，我們正為病患帶來具實質意義的影響。

Over the past 12 months, we have embarked on a period of rapid and deliberate transformation. I am incredibly proud of the execution by the entire Jazz team during this time and deeply grateful for the trust you have placed in our shared vision. That concludes our prepared remarks.

在過去 12 個月中，我們展開了一段快速且有計畫的轉型期。我對這段期間整個 Jazz 團隊的執行表現感到無比自豪，也由衷感謝各位對我們共同願景所給予的信任。以上為我們事先準備的發言。

I would now like to turn the call over to the operator to open the line for Q&A.

現在我想把電話交給接線員，開放問答（Q&A）。

(Operator Instructions) Marc Goodman, Leerink.

（接線員指示）Marc Goodman，Leerink。

Yes. Could you guys give us a little more color on Epidiolex? Just give us a sense of, was there any inventory in the US or anything strange in the quarter? I mean, what was really just driving it? Were there new indications? Just give us a sense of what's happening here because the quarter was much better than expected.

是的。你們能否再多談一些 Epidiolex 的情況？請讓我們了解一下，美國是否有任何庫存因素或本季是否有任何異常？我的意思是，究竟是什麼在驅動？是否有新的適應症？請讓我們了解目前發生了什麼，因為本季表現遠優於預期。

Hi there, Marc. This is Sam. Yeah, very pleased with the continued momentum that we've seen for Epidiolex. 16% revenue growth, taking us to $292 million for the quarter. This is 12% volume growth, which again just reflects really good, strong demand in both the pediatric and the adult settings, reinforcing our position as the number one branded anti-seizure medication in refractory epilepsy. I think some of this growth continues to come from our focus on the long-term care setting. As you know, we've generated some good data there. Beyond-seizure benefits really resonate with adults, and we continue to see good headroom for growth actually in that segment as well.

嗨，Marc。我是 Sam。是的，我們對 Epidiolex 持續展現的動能感到非常滿意。營收成長 16%，本季達到 2.92 億美元。這相當於 12% 的銷量成長，再次反映在兒科與成人治療場景中都存在非常良好且強勁的需求，並鞏固我們作為難治型癲癇第一大品牌抗癲癇藥物的地位。我認為部分成長仍來自我們對長期照護場域的聚焦。如你所知，我們在那裡已產出一些不錯的數據。「超越控制發作」的效益對成人族群很有共鳴，而我們也持續看到該細分市場其實仍有相當大的成長空間。

There were no really significant unusual inventory movements, but I'll hand over to Phil if he wants to comment further on that topic.

並沒有任何特別顯著的異常庫存變動，不過如果 Phil 想就此主題補充，我把時間交給他。

Yeah. Thanks, Sam. Just to note, Marc, ex-US, you may recall that in the second quarter last year, we had talked about some one-time pricing adjustments were made in a couple of the ex-US markets that did depress second-quarter 2025 revenue that led to some of the favorability on the compare in the second quarter of this year for ex-US revenue. And we also did have a decent effect in this first half of the year coming from FX that was most pronounced in the first quarter and came down pretty significantly here in the second quarter but did also help drive a little bit of the ex-US revenue growth.

好的。謝謝你，Sam。Marc，補充說明一下，在美國以外市場（ex-US），你可能記得去年第二季我們曾提到，在幾個海外市場進行了一次性價格調整，確實壓低了 2025 年第二季營收，這也使得今年第二季在海外營收的年對年比較上呈現較有利的表現。此外，今年上半年外匯（FX）也帶來了不小的影響，第一季最為明顯，而在第二季顯著下降，但仍對海外營收成長提供了一些助力。

Jessica Fye, JPMorgan.

Jessica Fye，摩根大通。

Wanted to ask about zani and just hoping you could speak to your confidence in approval heading into the upcoming PDUFA. There had been some talk about the possibility of maybe approval before the PDUFA date. We're getting pretty close now, so just wanted to hear your confidence there. And then maybe related to zani, can you speak to your confidence in the zani doublet hitting on OS with the upcoming interim?

想請教一下關於 zani，並希望您能談談在即將到來的 PDUFA 前，您對獲批的信心如何。之前曾有一些討論，提到可能在 PDUFA 日期之前就獲得批准。我們現在已經很接近了，所以想聽聽您對此的信心。另外，可能也與 zani 相關，您能談談對於 zani 雙聯方案在即將到來的期中分析中於 OS（總生存期）達標的信心嗎？

Correct, Jess. So we've been productively engaged with the FDA, and it does feel like we're in the home stretch. We're highly confident in the approval, I would still say, on or before the PDUFA date, and we are certainly ready to launch.

沒錯，Jess。所以我們一直與 FDA 進行富有成效的互動，確實感覺已進入最後衝刺階段。我們對獲批非常有信心；我仍會說，會在 PDUFA 日期當天或之前獲批，而且我們當然已準備好上市。

On your second question around the second interim for the doublet. Certainly, we had a great result at the very first interim, and certainly we have more power at this next turn. So looking forward to those results in 3Q of this year.

關於您第二個問題，也就是雙聯方案的第二次期中分析。當然，我們在第一次期中分析時取得了很好的結果，而在下一次分析時我們的統計把握度更高。因此期待在今年第三季看到那些結果。

Jason Gerberry, Bank of America.

Jason Gerberry，美國銀行。

Maybe one for Phil. When you look at the strength of Xywav in the first half, how do you see that carrying over into next year? Should investors look at the outperformance as more or less just delayed generics and more of a headwind in 2027, or do you think that the strength offers a rebasing of numbers going into 2027 for Xywav?

也許有一題給 Phil。當你看 Xywav 上半年表現的強勁程度，你認為這會如何延續到明年？投資人應該把這次超預期表現視為主要是學名藥延後所致、並在 2027 年形成更大的逆風，還是你認為這樣的強勁表現會讓 Xywav 在進入 2027 年時的基期（數字）上調？

Yeah, appreciate the question. Definitely extremely pleased with the performance of our field teams driving Xywav. It really is a pretty astounding and amazing story and really based in the unique benefits that Xywav offers as the only low-sodium oxybate. We've been seeing this resonate with physicians as well as patients. I think we've continued to see that during this year, probably leading to even slower uptake of generics than we might have originally anticipated, which is leading to some of the raises we have for the guidance this year.

是的，謝謝這個問題。我們對前線團隊推動 Xywav 的表現感到非常滿意。這確實是一個相當驚人、令人讚嘆的故事，主要基於 Xywav 作為唯一低鈉 oxybate 的獨特效益。我們看到這點在醫師與病患之間都引起共鳴。我認為我們今年持續看到這個趨勢，可能導致學名藥的採用速度比我們原先預期更慢，這也促成我們今年上調部分財測指引。

I would say that continues to put us in a really strong position as we think about the go-forward discussions that we might have with payers as well, given that the market continues to highly value the unique position that only Xywav occupies. So not ready to give specific guidance on '27 yet. We'll do that when we get to the fourth quarter '26 call early next year, but the momentum we've got gives us increasing confidence in the position that Xywav will have in this market on a go-forward basis.

我會說，這也讓我們在思考未來與付款方可能進行的討論時，處於非常有利的位置，因為市場仍高度重視只有 Xywav 才具備的獨特定位。因此目前還不準備提供 2027 年的具體指引。我們會在明年初、也就是 2026 年第四季電話會議時再提供，但我們目前的動能讓我們對 Xywav 未來在此市場中的地位更有信心。

Ash Verma, UBS.

Ash Verma，瑞銀。

Congrats on the progress here. Maybe just on the GEA market dynamic, can you talk about in terms of how many patients are in the major academic centers versus the large community practice network, and if you think that the adoption is going to look different one way or the other in either of these channels?

恭喜你們在這裡的進展。也許就 GEA 市場動態來問一下：你們能否談談主要學術中心的病患數量相較於大型社區診所網絡的分布情況，以及你們是否認為在這兩種通路中的採用情形會有所不同？

Yes, we do believe that for the GEA launch, obviously having a strong foundation of support from those academic centers is key, and of course, the data really has been well received by those physicians following the publication in The New England Journal of Medicine, and they're eagerly anticipating the launch. What will be very important with this launch, and something we really appreciate, is how important it will be for the community physicians to really understand the data and to quickly adopt Ziihera as the new standard of care in GEA. This is something that we're quite well prepared for because it pretty much mirrors the situation with Zepzelca.

是的，我們確實相信，對於 GEA 的上市而言，顯然來自那些學術中心的強力支持基礎是關鍵；當然，在《新英格蘭醫學雜誌》發表後，數據確實獲得這些醫師的高度肯定，他們也熱切期待產品上市。這次上市非常重要的一點、也是我們非常重視的，是社區端醫師必須真正理解這些數據，並迅速採用 Ziihera 作為 GEA 的新標準治療。我們對此準備相當充分，因為這幾乎與 Zepzelca 當時的情況如出一轍。

So we have a team already out there who are very well positioned. There is very strong overlap between Zepzelca and Ziihera, so they're well positioned to communicate the benefits of Ziihera to community physicians, and we anticipate good, strong uptake there for all the reasons that we've talked about previously. The overlap, the fact that we have the permanent J-code already established, and we have those relationships already in place.

因此我們已經有一支團隊在外面，且具備非常好的佈局。Zepzelca 與 Ziihera 之間有非常高度的重疊，因此他們很適合向社區端醫師傳達 Ziihera 的效益；基於我們先前談過的各項原因，我們預期那裡會有良好且強勁的採用。包括這種重疊性、我們已建立永久性的 J-code，以及我們已經建立起的合作關係。

Joe Thome, TD Cowen.

Joe Thome，TD Cowen。

Can you talk a little bit about the breakdown between frontline and second-line Zepzelca patients that are presenting at this point, just trying to understand a little bit how much the second-line label update will impact your thoughts on the long-term value of Zepzelca and your peak sales estimates there?

你們能否談談目前呈現的 Zepzelca 病患中，一線與二線的占比拆分？我想更了解二線適應症標籤更新，會在多大程度上影響你們對 Zepzelca 長期價值的看法，以及你們對其峰值銷售額的估計。

I'll take that one. Yeah, I mean, we're very pleased, obviously, since we launched Zepzelca in the first-line maintenance segment in October last year. We've seen really strong adoption of Zepzelca with those patients, and that's really what's driven the growth that we've seen over the last few quarters. 42% growth this quarter, taking us to $106 million. And that growth is really all being down to our success in that first-line segment. We estimate now that between 30% to 40% of our overall US sales are coming from that first-line maintenance segment, and of course, that's growing, and that is reinforced by the recent NCCN category listing elevated to Category 1 as a preferred regimen in first-line maintenance in combination with Tecentriq.

我來回答這題。是的，我們當然非常滿意；自從去年 10 月我們在一線維持治療（first-line maintenance）領域推出 Zepzelca 以來，我們看到 Zepzelca 在這些病患中的採用非常強勁，這也正是推動我們過去幾季所見成長的主因。本季成長 42%，使我們達到 1.06 億美元。而這個成長確實完全來自我們在一線領域的成功。我們目前估計，美國整體銷售中約有 30% 到 40% 來自一線維持治療領域；當然這個比例仍在上升，且近期 NCCN 類別列表提升至 Category 1、並列為與 Tecentriq 聯合用於一線維持治療的優選方案，也進一步強化了這點。

So whilst we have been seeing a gradual decline in that second-line business as a result of competition, but also as patients get initiated onto Zepzelca in the frontline segment, they're not going to get retreated in that second-line segment. We can expect the second-line business to erode. That's what we were anticipating, and of course with the announcement today, we may expect that to accelerate, but of course all of that is factored into the guidance that we've provided for this year.

因此，雖然我們確實看到二線業務因競爭而逐步下滑，但也因為病患在前線就開始使用 Zepzelca，他們就不會在二線再接受重新治療。我們可以預期二線業務會被侵蝕。這是我們原先就預期的；當然，隨著今天的公告，我們可能預期這個趨勢會加速，但這些都已納入我們今年所提供的指引之中。

Rob, would you like to add anything from your perspective on that?

Rob，你是否想從你的角度補充一些？

Yeah. I mean, I would just say that we designed the IMforte trial because we really felt that it was important to preempt progression in this pretty aggressive disease and had a strong hypothesis that Zepzelca would synergize with a PD-L1 inhibitor like atezolizumab, and that is what we observed in IMforte. So we think first-line maintenance is the best place to use Zepzelca for patients to get the best benefit and the longest treatment duration. We think there is a synergy with PD-L1 antagonists, and there was important data published at ASCO showing just that, looking at the impact of tumor-associated macrophages of Zepzelca and explaining the potential synergy with PD-L1 agents. So we do think frontline is the best place to use Zepzelca.

是的。我的意思是，我只想說，我們設計 IMforte 試驗，是因為我們真的認為在這種相當具侵襲性的疾病中，預先阻止疾病進展非常重要；我們也有很強的假設，認為 Zepzelca 會與 PD-L1 抑制劑（例如 atezolizumab）產生協同作用，而這正是我們在 IMforte 中觀察到的。因此我們認為，一線維持治療是讓病患使用 Zepzelca 的最佳時機，能獲得最佳效益與最長的治療持續時間。我們認為它與 PD-L1 拮抗劑存在協同作用；而在 ASCO 發表的重要數據也顯示了這點，探討 Zepzelca 對腫瘤相關巨噬細胞的影響，並解釋其與 PD-L1 藥物之間的潛在協同作用。所以我們確實認為前線是一個使用 Zepzelca 的最佳位置。

Sean Laaman, Morgan Stanley.

Sean Laaman，摩根士丹利。

Congratulations on the numbers, and hope everyone's well. My question is on the durability of Xywav. Most of the net patient adds came in IH, and I guess just given the biology of the disease with normal levels of orexin, and then you do have a pretty competitive bar there on perusal of the medical literature in terms of MWT. How do you think that evolves the mix of Xywav for patients on IH, and how defendable or otherwise do you think it may be as orexin agonists advance? Thanks.

恭喜這次的數字，也希望大家都一切安好。我的問題是關於 Xywav 的持久性。大多數的淨新增病患來自 IH，我想考量到該疾病的生物學特性（orexin 水準正常），而且從醫學文獻來看，在 MWT 方面你們面臨的競爭門檻也相當高。你們認為這會如何影響 IH 病患使用 Xywav 的組合占比？以及隨著 orexin 促效劑（agonists）推進，你們認為其可防禦性如何、或是否會受到影響？謝謝。

Yes, of course, we're very pleased with the durability that we've seen for Xywav. We did, as you mentioned, have really good solid patient adds this quarter, 200 for narcolepsy, 325 for idiopathic hypersomnia, in total 525 net patient adds. It's actually the highest number of adds that we've had for a year, so very happy to see that continued momentum. Obviously the brand is proving itself to be very durable in the face of multisource generics.

是的，當然，我們對於 Xywav 目前展現出的持久性非常滿意。如你所提到的，本季我們的病患新增非常穩健：嗜睡症新增 200 位、特發性嗜睡（idiopathic hypersomnia）新增 325 位，合計淨新增 525 位病患。這其實是我們一年來最高的新增數，因此很高興看到這股動能持續。顯然，面對多來源學名藥（multisource generics），這個品牌仍證明了其高度持久性。

That's perhaps not surprising given the differentiation factors for Xywav haven't changed with the availability of multisource generics. We're still the only low-sodium oxybate on the market, the only product approved for IH. Obviously, as we look ahead, we are anticipating the launch of the orexins.

考量到 Xywav 的差異化因素並未因多來源學名藥的上市而改變，這或許並不令人意外。我們仍是市場上唯一的低鈉 oxybate，也是唯一獲准用於 IH 的產品。當然，展望未來，我們也預期 orexin 類藥物將會上市。

And I'll maybe get Rob to comment a little bit on how he's seeing the potential combinability of orexins with Xywav. Rob?

我可能請 Rob 也談談他如何看待 orexin 與 Xywav 的潛在併用可能性。Rob？

Yeah, thanks, Sam. Across the hypersomnia NT1, NT2, IH, the root cause really is disrupted nighttime sleep, and Xywav is the only approach to address the disrupted nighttime sleeping. So we think it's a cornerstone of therapy there. It's been the case that patients will also use daytime-stimulating agents, and we think that orexins offer another opportunity to complement the potential benefit of oxybates and specifically Xywav.

好的，謝謝，Sam。在嗜睡相關疾病（NT1、NT2、IH）中，根本原因其實是夜間睡眠被干擾，而 Xywav 是唯一能夠處理夜間睡眠受干擾這一問題的方法。因此我們認為它是治療中的基石。一直以來病患也會使用日間促醒/刺激藥物（daytime-stimulating agents），而我們認為 orexin 提供了另一個機會，可補強 oxybate、尤其是 Xywav 的潛在效益。

Mohit Bansal, Wells Fargo.

Mohit Bansal，富國銀行。

Hi. This is Will Zhang on for Mohit. Thanks for taking our question. So just looking at zani's Phase 3 trial in breast cancer, just want to understand, given that you guys are developing in this post-TDXT, post-Enhertu setting, what is the patient pool? What is the size of the patient population that you're looking to address here since Enhertu is still beginning its -- in the early phases of its launch into the first-line breast cancer setting?

嗨。我是代 Mohit 提問的 Will Zhang。謝謝讓我們提問。我們在看 zani 的乳癌三期試驗，想了解一下：鑑於你們是在 post-TDXT、post-Enhertu 的治療情境中開發，目標病患池是哪些人？由於 Enhertu 仍在早期階段、正逐步導入乳癌一線治療，你們在此要涵蓋的病患族群規模有多大？

Do you want to jump in a bit on the trial?

你要不要先補充一下這個試驗？

Yeah, so the trial is positioned in patients who have been treated with Enhertu, and in the current treatment paradigm that's typically third line-plus patients. I remind you that we have data showing that zanidatamab, given its unique mechanism of action, is active even in patients who've progressed on Enhertu, and that comes from monotherapy data. It comes from combination data with standard of care, say, in the HER2-positive, ER-positive population that we published, and also with novel agents like the ALX agent.

好的。這個試驗定位在已接受 Enhertu 治療的病患；在目前的治療典範下，這通常是三線以上（third line-plus）的病患。我提醒大家，我們已有數據顯示，zanidatamab 因其獨特的作用機轉，即使在對 Enhertu 進展（progressed）的病患中仍具活性，而這來自單藥（monotherapy）數據。也來自與標準治療（standard of care）的合併數據，例如我們已發表的 HER2 陽性、ER 陽性族群；此外也包含與新型藥物（如 ALX 藥物）的合併數據。

We think this is roughly 150,000 patients annually. And we also feel that it's a significant unmet need. As Enhertu progressively moves to the frontline, the zanidatamab would be, I think, unique in having data demonstrating its activity versus standard of care in patients who progress on Enhertu, regardless of the line of therapy. So we're eager to see those results. We've said in the past that we expect to see the trial complete enrollment mid-2027, and we could see results, depending on how the events progress, late 2027 or early 2028.

我們認為這大約是每年 150,000 名病患。我們也認為這是一個重大的未被滿足醫療需求。隨著 Enhertu 逐步前移到一線，我認為 zanidatamab 的獨特之處在於：不論治療線別為何，它都有數據證明在對 Enhertu 進展的病患中，相較於標準治療仍具活性。因此我們很期待看到結果。我們過去也提到，預期該試驗將在 2027 年年中完成收案；而結果則視事件累積進度而定，可能在 2027 年底或 2028 年初出爐。

Leonid Timashev, RBC Capital.

Leonid Timashev，RBC Capital。

I wanted to ask on the Epidiolex strategy from here, maybe how the pieces there fit together. You guys are running a number of additional studies, LGS in adults, DEE, JME, and there's also this new capsule formulation. I guess what I'm trying to understand is how are, to what extent is this growing the opportunity versus defending it from future branded entrants as the DEE space sort of heats up competitively, and then is this new capsule formulation something that's going to extend the IP runway as well? .

我想問一下接下來 Epidiolex 的策略，可能想了解各個部分如何拼在一起。你們正在進行多項額外研究：成人 LGS、DEE、JME，另外還有新的膠囊劑型。我想理解的是：這些舉措在多大程度上是在擴大機會、而不是在 DEE 領域競爭升溫、未來品牌競品進入時用來防守？以及這個新的膠囊劑型是否也會延長 IP 的保護年限（runway）？.

Yeah, thanks. I'll start and then also welcome comments from Sam and Rob in terms of both the broader commercial opportunity and some of what we are investing in on the clinical side. But if you step back and think about Epidiolex as a growth driver for the company, with the visibility of long durability into the very late 2030s now with this franchise, we believe we have multiple opportunities to invest. We talked today about multiple clinical programs underway, and we also believe having the capsule formulation allows us greater potential penetration into the adult market for certain patients who are more suitable for the capsule formulation. And if we step back and think about the impact that this business development transaction of bringing Epidiolex into the company has had for us, it's created now a major growth driver.

好的，謝謝。我先回答，之後也歡迎 Sam 和 Rob 就更廣泛的商業機會，以及我們在臨床端的投資補充。但如果退一步看，把 Epidiolex 視為公司成長驅動力：在這個產品線如今可望延續到 2030 年代末期的長期持久性（durability）能見度之下，我們相信有多個投資機會。我們今天談到多個正在進行的臨床計畫；我們也相信膠囊劑型能讓我們在成人市場對某些更適合膠囊的病患，取得更高的滲透率。再退一步看，這筆將 Epidiolex 納入公司的業務開發交易，已為我們帶來重大影響：它現在已成為主要的成長驅動力。

We paid a little over $7 billion for what is a franchise that is growing nicely, over $1 billion a year, with the opportunity to grow in multiple formulations through clinical data and also internationally. It's a really nice business for us to be in and also continue to build around when we think about future business development transactions.

我們支付了略高於 70 億美元，換得的是一個成長良好的產品線：年營收超過 10 億美元，並且可透過多種劑型、臨床數據以及國際市場來擴大成長。這對我們而言是一門很好的業務，也是在我們思考未來業務開發交易時，可以持續圍繞並加以建構的基礎。

Sam, do you want to comment further on the capsule?

Sam，你要不要再補充一下膠囊劑型？

Yeah, happy to. Yeah, we're very excited about the potential for Epidiolex to continue its strong momentum into the future. We have seen, and we continue to execute on our strategy to grow Epidiolex in the adult segment. We continue to see growth in keeping patients on treatment for longer, and that persistency is really very material in terms of the long-term outlook. And we also identify an opportunity for patients to restart Epidiolex who may have previously discontinued treatment, and when you look at the capsule formulation, the capsule formation is going to enable us to do all of those things even better, particularly for those adolescent and adult patients where the oral liquid solution is a less convenient option for them.

好的，很樂意。是的，我們對 Epidiolex 未來持續維持強勁動能的潛力感到非常振奮。我們已看到、並持續執行我們在成人族群擴大 Epidiolex 的成長策略。我們也持續看到讓病患更長時間維持治療所帶來的成長，而這種治療持續性（persistency）對長期展望非常關鍵。此外，我們也看到一個機會：讓先前可能停用的病患重新開始使用 Epidiolex；而就膠囊劑型而言，它將使我們把上述各項做得更好，特別是對於青少年與成人病患，口服液劑對他們而言較不便利。

So we believe the capsule will enable us to capture naive patients, improve persistency in existing patients, and encourage restarts for patients that maybe started on the oral solid dose on the liquid, and it wasn't the best treatment for them. So we do believe when you take all of those together, this is a material incremental opportunity that will drive more patients benefiting from Epidiolex.

因此我們相信，膠囊將使我們能夠吸引未治療過（naive）的病患、提升既有病患的治療持續性，並鼓勵那些可能曾使用口服液劑、但那並非最適合他們的治療方式的病患重新開始用藥。因此我們確實相信，綜合以上因素，這是一個具實質增量的機會，將讓更多病患受益於 Epidiolex。

And maybe just to hit your IP question before Rob jumps in. The capsule launch does not have any impact on IP. It does not have any impact on our ANDA agreements that extend the durability, as I mentioned, out to the very late 2030s. Our patent estate contains method-of-use patents that are relevant to all approved indications, and that's relevant to both the existing oral solution as well as the new capsule formulation.

也許在 Rob 插話之前，我先回應你關於 IP 的問題。膠囊劑型的上市不會對 IP 造成任何影響。它也不會影響我們的 ANDA 協議；如我提到的，這些協議將保護期的耐久性延伸到 2030 年代非常後期。我們的專利組合包含與所有已核准適應症相關的用途方法（method-of-use）專利，這同時適用於既有的口服溶液以及新的膠囊配方。

Rob, do you want to cover now the clinical programs?

Rob，你現在要不要說明臨床計畫？

Yeah. So we're excited to be initiating a number of new clinical trials with Epidiolex. We're convinced of its broad activity across different seizure types based on prior data we have for the current indications and the EAP. And so about a year ago, we initiated a Phase 2 trial of focal-onset seizures. We've just announced a trial we initiated in juvenile myoclonic epilepsy that will be with the capsule formulation, and that's a Phase 2/3 seamless design, so potentially pivotal.

好。我們很興奮即將啟動多項使用 Epidiolex 的新臨床試驗。根據我們在目前適應症以及 EAP 的既有數據，我們確信它對不同癲癇發作類型具有廣泛活性。因此大約一年前，我們啟動了一項針對局灶性起始發作（focal-onset seizures）的第 2 期試驗。我們也剛宣布啟動一項青少年肌陣攣性癲癇（juvenile myoclonic epilepsy）試驗，將採用膠囊劑型，且為第 2/3 期無縫設計（seamless design），因此可能具關鍵性（pivotal）。

We also are initiating a trial in a broad set of DEEs that could lead to a broader label there. That would be pivotal. And doing some more work in adult LGS patients to really try to better characterize its efficacy there and support its use from adult prescribers. So confident in the activity that Epidiolex has, its ability to combine, and as has already been said, because of the longevity that we're initiating new trials in this space.

我們也正在啟動一項涵蓋廣泛 DEEs 的試驗，可能帶來更廣的標籤適應症。那將會是關鍵性試驗。此外，我們也在成人 LGS 病患上做更多工作，以更好地刻畫其療效並支持成人處方醫師的使用。因此，我們對 Epidiolex 的活性、其合併用藥能力充滿信心；也如先前所說，基於其長期性，我們正在此領域啟動新的試驗。

And then since I have the mic, I just want to make sure my comments earlier on breast cancer for Ziihera were understood. 150,000 really represents the pool of metastatic patients globally. So obviously it's a subset of that who would have progressed and still are eligible for treatment after Enhertu.

另外既然我在發言，我想確保我先前對 Ziihera 乳癌的評論被正確理解。150,000 其實代表的是全球轉移性病患的總池。所以很明顯，真正會在 Enhertu 之後疾病進展且仍符合治療資格的，只是其中的一個子集合。

David Amsellem, Piper Sandler.

David Amsellem，Piper Sandler。

So I have a long-term question on the oxybate franchise, namely Xywav and IH. So obviously we have the data in hand for Lumryz and just wondering how you're thinking about the trajectory of IH. It's obviously growing nicely. There's good headroom here. That's definitely not lost on me.

我有一個關於 oxybate 產品線的長期問題，主要是 Xywav 與 IH。我們顯然已經掌握 Lumryz 的數據，想請教你們如何看待 IH 的發展軌跡。它顯然成長得不錯。這裡還有很大的成長空間。我也完全注意到了這點。

But the question is, once you do have that competition emerging in '28, how do you think about your growth trajectory longer term, and then even beyond that with potential availability of orexins? So if you just comment on how you're thinking about the next several years for your IH part of your Sleep business, that would be helpful.

但問題是，一旦你們在 2028 年面臨競爭出現，你們如何看待更長期的成長軌跡？以及再往後，若 orexin 類藥物可能上市，又會如何影響？所以如果你們能評論一下未來幾年你們睡眠事業中 IH 這一塊的規劃思路，會很有幫助。

I can certainly start and then maybe hand over to Rob. Yeah, I mean, the differentiation for Xywav is twofold, and perhaps one of the most important things about Xywav is the low sodium. And of course that's going to be a component of differentiation that will go beyond just another product having an IH indication. And this is a message that really does resonate with prescribers. We know that patients who are diagnosed with IH or narcolepsy, the majority of them do have a cardiometabolic or cardiovascular comorbidity, and so increasingly I think physicians and patients recognize the importance of having a low-sodium option.

我可以先回答，然後也許再交給 Rob。是的，我的意思是，Xywav 的差異化有兩個面向，而其中最重要的一點可能就是低鈉。當然，這會是一個差異化要素，不會只因為另一個產品也取得 IH 適應症就消失。而且這個訊息確實能引起處方醫師的共鳴。我們知道，被診斷為 IH 或嗜睡症（narcolepsy）的病患，多數都有心代謝或心血管共病，因此我認為醫師與病患愈來愈能理解擁有低鈉選項的重要性。

And that differentiation is obviously pretty durable. So in relation to the orexin question, maybe I'll hand that over to Rob.

而這種差異化顯然相當持久。至於 orexin 的問題，也許我交給 Rob 來回答。

Thanks, Sam. I was just going to add, again, that Xywav is differentiated on the basis of low sodium. While it's well understood that not only narcolepsy, but IH patients have a significant risk of negative cardiometabolic outcomes. We also demonstrated that in the XYLO study that after initiation of high-sodium oxybate, you see a change in blood pressure, which is clinically meaningful. So patients benefiting from XYWAV now, I think that will be pretty sticky.

謝謝，Sam。我只是想補充，Xywav 的差異化基礎同樣在於低鈉。大家都很清楚，不只是嗜睡症，IH 病患也有顯著的心代謝不良結局風險。我們也在 XYLO 研究中證明，開始使用高鈉 oxybate 後，血壓會出現變化，而且具有臨床意義。因此我認為目前受益於 XYWAV 的病患黏著度會很高。

Did I miss another aspect of the question on narcolepsy that you wanted me to address, Sam?

Sam，我是不是漏掉了你希望我回應的嗜睡症問題的其他面向？

I think there were questions just around the competition versus the longer-term availability of orexins.

我想還有一些問題是關於競爭，以及 orexin 長期可能上市的影響。

Yeah, I mean, I think I answered this earlier. Whether it be IH or narcolepsy, the root cause of the daytime sleepiness and symptoms such as cataplexy have to do with disrupted nighttime sleep, and only oxybates, and Xywav being really the safest oxybate, can address that root cause. And so we continue to think that that will have an important role in treating patients, even if they would additionally benefit from daytime wake-promoting agents.

是的，我想我先前已經回答過。不論是 IH 或嗜睡症，日間嗜睡以及像猝倒（cataplexy）等症狀的根本原因，都與夜間睡眠被打斷有關；而只有 oxybate 類藥物——其中 Xywav 可說是最安全的 oxybate——能夠處理這個根本原因。因此我們仍認為，即使病患也可能額外受益於日間促醒藥物，oxybate 在治療上仍將扮演重要角色。

And just to build one last point here with respect to the IH market, we are still very early in our overall penetration. We think there's probably 37,000-plus patients diagnosed and seeking treatment for IH, and while we've made significant progress and headway, we do believe there's a lot of room still to grow here. And we believe that Xywav, as we've seen with narcolepsy, including the patient support services supporting the overall journey that patients go through with a new diagnosis of idiopathic hypersomnia, we do believe that Xywav will continue to compete well in this market.

另外再補充最後一點，關於 IH 市場，我們目前在整體滲透率上仍非常早期。我們認為大概有 37,000 名以上的病患已被診斷並正在尋求 IH 治療；雖然我們已取得顯著進展與突破，但我們相信仍有很大的成長空間。而且我們相信 Xywav——正如我們在嗜睡症所看到的——包含病患支持服務在內，能支持病患在新診斷為特發性嗜睡症後所經歷的整體歷程；因此我們確信 Xywav 將持續在此市場具備良好的競爭力。

Ami Fadia, Needham.

Ami Fadia，Needham。

I had a question on zani and if you think about potential indications beyond breast cancer. Can you talk about what type of updates we could expect with regards to CRC or non-small cell lung cancer and how you might go about pursuing those indications?

我想問關於 zani，以及你們是否在思考乳癌以外的潛在適應症。你能談談在 CRC 或非小細胞肺癌方面，我們可以期待哪些更新，以及你們可能會如何推進這些適應症嗎？

Sure. So we have the ongoing basket trial, which is the 206 study, and in that trial, we continue to enroll patients with second-line colorectal cancer and non-small cell lung cancer. We had previously published on colorectal cancer, and those were some of the data that we brought to FDA, including in addition data from the emerging 206 trial that led to the breakthrough designation for colorectal cancer. So we'll continue to generate data in both of those indications through that study, and we'll work with FDA now that we have BTD to identify the path forward ultimately for approval in colorectal cancer.

當然。我們正在進行中的籃式試驗（basket trial），也就是 206 研究；在該試驗中，我們持續納入二線結直腸癌與非小細胞肺癌病患。我們先前已發表過結直腸癌的結果；那些就是我們帶去與 FDA 溝通的部分數據，此外也包含來自正在進行的 206 試驗的新興數據，並促成結直腸癌的突破性療法認定（breakthrough designation）。因此我們將透過該研究持續在這兩個適應症上產出數據；而且既然我們已取得 BTD，我們也會與 FDA 一起釐清結直腸癌最終走向核准的前進路徑。

And more broadly, we're very excited about the potential of zanidatamab. We have the ongoing first-line BTC trial that we're optimistic about. As you know, we're about to launch in GEA. We're contemplating other areas in gastric cancer, such as early gastric cancer where there's no approved HER2 therapy. Of course, we have the ongoing late-stage metastatic breast cancer trial as well as other Phase 2 trials looking to determine how else we might use zanidatamab in combinations, sometimes novel combinations, in the breast cancer setting, as well as new indications such as CRC and non-small cell lung cancer, as you mentioned. So overall, we do think this is a pipeline in a product, and we're pursuing every opportunity to its fullest.

更廣泛來說，我們對 zanidatamab 的潛力感到非常振奮。我們有正在進行的一線 BTC 試驗，對其結果抱持樂觀。如你所知，我們即將在 GEA 上市。我們也在思考胃癌的其他領域，例如早期胃癌，目前尚無已核准的 HER2 治療。當然，我們也有正在進行的晚期轉移性乳癌試驗，以及其他第 2 期試驗，目的是釐清我們還能如何在乳癌情境中以合併療法（有時是新穎的合併）使用 zanidatamab，同時也探索你提到的 CRC 與非小細胞肺癌等新適應症。總體而言，我們確實認為這是一個「產品即管線」（pipeline in a product），我們正全力追求每一個機會。

Gary Nachman, Canaccord.

Gary Nachman，Canaccord。

So for Ziihera and GEA, just back to that. If approved, how long before you think the NCCN guidelines will be updated since you already submitted the data for that, and how much would that impact the uptake? And I'm also curious, has there been any real off-label use in first-line GEA since the data came out late last year? Maybe just generally a bit more on how you're thinking about the pace of the uptake in GEA, including with reimbursement, because you obviously can leverage the BTC indication and have a lot in place already.

所以回到 Ziihera 和 GEA 的問題。若獲核准，您認為 NCCN 指南在您已提交相關數據的情況下，多久會更新？這對採用速度會有多大影響？另外我也好奇，自從去年年底數據公布後，在一線 GEA 是否已有任何實質的超適應症（off-label）使用？也想更廣泛地了解你們如何看待 GEA 的採用節奏（包含給付/報銷），因為你們顯然可以利用 BTC 適應症，且已有許多基礎建置。

I can start on NCCN. We've been providing NCCN all the data we have as soon as we have it. We shared the data that went into the abstract, and then we immediately shared the New England Journal publication. Obviously, we don't control their timelines, but we do think they have everything they need to adopt that into the guidelines, potentially even before approval, but obviously that's up to them.

我可以先談 NCCN。我們一有數據就會盡快提供給 NCCN。我們分享了納入摘要（abstract）的數據，接著也立即分享了《新英格蘭醫學期刊》的發表內容。顯然我們無法掌控他們的時程，但我們確實認為他們已具備將其納入指南所需的一切資料，甚至可能在核准前就納入，但當然這取決於他們。

Yeah. And so I'll follow up with your question in relation to our readiness to launch. I mean, we are ready to launch in GEA. We sized our team specifically with a GEA launch in mind and made some investments to ensure that we can cover all of the customer groups that we want to cover very rapidly at launch. BTC for us will serve as a powerful foundation for the next major growth phase in GEA. There are a number of features around our presence in BTC that make us very confident that we will be able to launch successfully and rapidly.

是的。我接著回應你關於我們上市準備度的問題。我們的確已準備好在 GEA 上市。我們在規劃團隊規模時就是以 GEA 上市為目標，並投入一些資源，以確保上市時能非常迅速地覆蓋我們希望覆蓋的所有客戶群。對我們而言，BTC 將成為在 GEA 進入下一個主要成長階段的強大基礎。我們在 BTC 的布局有多項特點，使我們非常有信心能成功且快速地上市。

We have more than 90% physician overlap between GEA treating centers. We obviously have access already established with a permanent J-code already active from the BTC approval. We've submitted the data to Oncology Pathways, and we have onboarded a team of clinical nurse educators who are ready to support smooth, efficient access, and patient onboarding, really leveraging our JazzCares program.

在 GEA 治療中心之間，我們的醫師重疊度超過 90%。此外，因 BTC 核准，我們已建立通路並且已有永久性的 J-code 正在使用。我們已將數據提交至 Oncology Pathways，並已招募一支臨床護理衛教師團隊，隨時準備支援順暢且高效率的給付取得與病患導入，並充分運用我們的 JazzCares 計畫。

So we are ready, and we think our readiness combined with the data, the compelling nature of the data, which you're all familiar with by now, means that we should see really very rapid uptake, and we're committed to ensuring that patients who need this product can get it as soon as possible.

因此我們已準備就緒；我們認為，這樣的準備度加上數據本身及其說服力（各位現在都很熟悉了），意味著我們應會看到非常快速的採用；我們也承諾確保需要這項產品的病患能盡快取得治療。

Akash Tewari, Jefferies.

Akash Tewari，Jefferies。

Hey, this is Anastasia on for Akash. Thanks for taking the question. Congrats on the quarter. So on the post-Enhertu trial, I know your comparator arm as tras plus physician's choice chemo, I believe, but it looks like the NCCN guidelines list tucatinib plus tras and capecitabine as the preferred second- or third-line regimen. Can you talk us through how you chose the comparator arm and what you consider the bar for success in the trial, as well as what is considered clinically meaningful? Also, just verifying you're still on track to complete enrollment in the first half of 2027.

嗨，我是代 Akash 提問的 Anastasia。謝謝讓我提問。恭喜本季表現。關於 post-Enhertu 試驗，我知道你們的對照組是 trastuzumab（tras）加上醫師選擇的化療（physician's choice chemo），我記得是這樣；但看起來 NCCN 指南將 tucatinib 加 tras 與 capecitabine 列為偏好的二線或三線方案。能否說明你們如何選擇對照組，以及你們認為此試驗成功的門檻為何、何者被視為具臨床意義？另外確認一下，你們仍按計畫在 2027 年上半年完成收案嗎？

On the second part of the question, yes, we're on track to complete enrollment by mid-year 2027. When we have results will depend on the events, but we haven't changed our guidance on that for end of 2027, 2028. In terms of the design of the trial, most of the data with other HER2 agents were generated before the availability of Enhertu. So that's really the motivation for this trial. It's unclear what to use once patients have progressed on Enhertu.

關於問題的第二部分，是的，我們仍按計畫在 2027 年年中前完成收案。何時能有結果取決於事件數（events），但我們對於 2027 年底、2028 年的指引並未改變。就試驗設計而言，多數其他 HER2 藥物的數據是在 Enhertu 可用之前產生的。因此這正是進行此試驗的動機。在病患於 Enhertu 治療後出現疾病進展時，接下來該用什麼仍不明確。

The trial is set up to be a third-line-plus trial. It's a global trial, so in some places that will mean that patients may have gotten tucatinib previously, but in some parts of the world, such as South Korea, tucatinib is not commonly used. And so it'll be a trial where you'd expect third-, fourth-, or even possibly fifth-line patients. While that's a poor-prognosis group, we have prior data suggesting that zanidatamab can be active in that setting, and again, this is a head-to-head against Herceptin. And so we continue to be confident in zani's ability to be what would be the standard of care in certain settings.

此試驗設定為三線以上（third-line-plus）的試驗。這是一項全球性試驗，因此在某些地區代表病患可能先前已使用過 tucatinib，但在世界某些地方，例如南韓，tucatinib 並不常用。因此這會是一項你會預期納入三線、四線，甚至可能五線病患的試驗。雖然這是一個預後不佳的族群，但我們先前的數據顯示 zanidatamab 在該情境下可能具有活性；而且再次強調，這是一項與 Herceptin 的頭對頭比較。因此我們仍對 zani 在某些情境下成為標準治療（standard of care）的能力保持信心。

Etzer Darout, Barclays.

Etzer Darout，Barclays。

Great. Thanks for taking the question. Just a follow-up on comments around Xywav and guidance from Phil earlier. Just wondering how much of that change in the sleep franchise revenue guidance is revised expectations on generics in 2026? Maybe related to that, if you could provide any additional color on the additional investments for Xywav and Epidiolex reflected in the SG&A guidance that would be helpful.

很好。謝謝讓我提問。我想追問一下先前 Phil 對 Xywav 與指引的評論。想請教睡眠產品線營收指引的這次變動，有多少是因為對 2026 年學名藥的預期有所修正？也相關地，若能就 SG&A 指引中反映的、對 Xywav 與 Epidiolex 的額外投資提供更多說明，會很有幫助。

Yeah, this is Phil. Thanks for the question. Maybe I'll take the first part and then turn it over to Sam for color behind some of the additional investments to drive even further momentum and revenue growth for Xywav and Epidiolex.

是的，我是 Phil。謝謝你的問題。我先回答第一部分，然後再請 Sam 補充一些關於額外投資的背景，這些投資旨在進一步推動 Xywav 與 Epidiolex 的動能與營收成長。

So the revised guidance really comes down to extremely strong execution in the field that's led to this unique benefit that XYWAV has resonating with physicians and patients, which we believe is what's likely leading to the very slow uptake that we're seeing of generic high-sodium oxybates. We had said all along that we didn't expect really much of any impact in the first half of the year, and that impact has played out as we had expected. However, based on the pace of introduction of the high-sodium generics, we're now expecting a much more muted impact in the back half of the year as well that is behind the guidance raise for Xywav, where before we had expected the product to be flat to up mid-single digits this year, and now we're expecting double-digit growth for the full year. So really pleased with the momentum that we have and look for that to continue. Sam?

這次上修指引主要源自我們在前線（field）的極強執行力，使 XYWAV 的獨特效益在醫師與病患間產生共鳴；我們相信這很可能是我們看到高鈉 oxybate 學名藥採用非常緩慢的原因。我們一直以來都表示，預期上半年幾乎不會有太大影響，而實際影響也如我們所預期地發生。然而，基於高鈉學名藥的導入節奏，我們現在也預期下半年影響會更為溫和，這也是我們上調 Xywav 指引的原因：先前我們預期今年該產品營收持平至中個位數成長，現在我們預期全年將達到雙位數成長。因此我們對目前的動能非常滿意，並期待其延續。Sam？

Yeah, and in terms of the investments that we're making, obviously given the strong resilience of Xywav and momentum, we are continuing to invest in some of the media spend that has been particularly effective in ensuring that diagnosed patients get treated with Xywav, as well as some continued investment in the patient support program.

是的，關於我們正在進行的投資，鑑於 Xywav 的強勁韌性與動能，我們持續投入部分媒體支出；這些支出在確保已確診病患接受 Xywav 治療方面特別有效，同時也持續投資於病患支持計畫。

For Epidiolex, we have continued to invest and upgraded our investment in ensuring that we can fully penetrate the LTC adult segment, where we've started to see some good inroads. And also, we do see an opportunity to drive persistency, and we have invested to expand our JazzCares program so that more patients can get enrolled onto the JazzCares program. We know those patients generally do better on treatment, and in addition, of course, we're starting to prepare for the oral solid-dose launch as well. So that's the nature of some of the additional investments that are outlined in the guidance.

至於 Epidiolex，我們持續投資並提高投入，以確保我們能充分滲透 LTC 成人族群（long-term care），目前我們已看到一些良好進展。此外，我們也看到提升治療持續性（persistency）的機會，因此我們投資擴大 JazzCares 計畫，讓更多病患能加入 JazzCares。我們知道這些病患通常在治療上的表現更好；另外，當然我們也開始為口服固體劑型（oral solid-dose）的上市做準備。以上就是指引中所列部分額外投資的性質。

Brian Skorney, Baird.

Brian Skorney，Baird。

Hi. This is Luke on for Brian. Thanks for the question. Just one quick one on business development strategy. Can you provide any color on particular areas of interest within Rare Disease or with regard to development stage you'd be looking for, or would you say you're fairly agnostic?

嗨。我是 Luke，代替 Brian 發言。謝謝你的提問。我這邊有一個關於業務開發策略的簡短問題。你能否就罕見疾病領域中特別感興趣的方向，或是你們會尋找的開發階段，提供一些說明？還是你會說你們相對不偏好特定方向、較為中立？

Yes, this is Renee. Thanks for the question. So we won't comment on specific deals for obvious reasons, but I would say we do remain highly engaged on the BD front. I'll remind you that we hired a new CBO earlier this year to drive those efforts, and we do continue to expect to announce one or more deals still in 2026. In terms of the areas that we're interested in, we really do focus on where we believe there's a significant unmet need and where we believe we can have a meaningful impact with our unique either expertise, global footprint, or current other operations that we have underway.

是的，我是 Renee。謝謝你的提問。基於顯而易見的原因，我們不會評論特定交易，但我會說我們在 BD（業務開發）方面仍然高度投入。提醒大家，我們今年稍早聘請了一位新的 CBO 來推動這些工作，我們也仍預期在 2026 年內宣布一筆或多筆交易。就我們感興趣的領域而言，我們確實聚焦在我們認為存在重大未被滿足需求、且我們能憑藉獨特的專業能力、全球佈局，或目前正在進行的其他營運，帶來實質影響的地方。

We generally will look for an efficiency of commercial call point, one where the support services that we do offer to our patients can also be relevant and valued. We are focused on strengthening our current areas of Rare Epilepsy, Rare Sleep, and Rare Oncology. We think there's a lot of substrate there, but we are also looking into other areas of Rare Disease. We'll delay on actually providing much commentary there because there are so many different areas that we could go into that I wouldn't want to be too specific there in terms of inadvertently commenting on specific deals we might be interested in.

一般而言，我們會尋找商業端觸及點（commercial call point）的效率，也就是我們提供給病患的支援服務同樣能夠相關且被重視的領域。我們聚焦於強化目前在罕見癲癇、罕見睡眠疾病與罕見腫瘤學的既有領域。我們認為那裡有很大的基礎，但我們也在探索其他罕見疾病領域。我們會暫時不做太多評論，因為可切入的領域非常多，我不希望在不經意間對我們可能感興趣的特定交易做出過於具體的評論。

In terms of the stage, we were really excited to announce the AbCellera deal this last quarter. That is a preclinical collaboration looking at next-generation T-cell engagers, so very early in our pipeline, but it directly aligns with our overall Rare Disease strategy, really expanding our focus on GI cancers. We are also, though, looking at later pipeline deals as well as commercial and near-commercial transactions. It really depends on the specific asset and the type of deal that we are interested in.

就階段而言，我們非常興奮能在上一季宣布與 AbCellera 的交易。那是一項臨床前合作，聚焦於下一代 T 細胞接合器（T-cell engagers），因此在我們的產品線中屬於非常早期，但它與我們整體的罕見疾病策略直接一致，並進一步擴大我們對 GI 癌症的關注。不過，我們也在看較後期的產品線交易，以及商業化與接近商業化的交易。這真的取決於特定資產以及我們感興趣的交易類型。

Importantly, we have a strong track record of doing deals that have generated meaningful value. I mentioned Epidiolex with GW earlier. Last year, we did the Modeyso Chimerix transaction that was near commercial, obviously. And then we've talked quite a bit on this call about zani that also came into our business via business development, which we're incredibly pleased by.

重要的是，我們在執行能創造實質價值的交易方面有很強的過往紀錄。我先前提到與 GW 的 Epidiolex。去年，我們完成了 Modeyso 與 Chimerix 的交易，那顯然是接近商業化的。此外，我們在本次電話會議中也談了不少 zani，它同樣是透過業務開發導入我們的業務，我們對此非常滿意。

And I'll just close with a reminder that we're in an incredibly strong financial position to be able to execute on BD. We generated $824 million in cash flow in the first half of this year, $2.2 billion of cash on the balance sheet, so supports our ability to execute in BD in addition to the investments that we've talked about throughout the call today behind our commercial brands as well as our pipeline.

最後我也提醒一下，我們的財務狀況非常強健，足以執行 BD。今年上半年我們產生了 8.24 億美元的現金流，資產負債表上有 22 億美元現金，這支持我們在 BD 上的執行能力，同時也能支應我們今天在電話會議中談到的投資，包括我們的商業品牌以及產品線。

Thank you. And ladies and gentlemen, that's all the time we have for Q&A session. I will now turn the call back over to Renee for any closing comments.

謝謝。各位女士、先生，問答時間到此結束。我現在把電話交回給 Renee，請她做結語。

Great. Thank you, operator. Well, I'd like to close today's call by thanking all of our employees as well as our partners and stakeholders for their continued confidence and support. We look forward to sharing additional updates on the potential approval of zanidatamab in GEA, as well as other progress in our business. Looking forward to sharing those updates with you over the remainder of the year.

好的。謝謝你，主持人。我想在今天的電話會議結束前，感謝我們所有員工，以及我們的合作夥伴與利害關係人，持續給予信任與支持。我們期待就 zanidatamab 在 GEA 的潛在核准，以及我們業務的其他進展，分享更多更新。也期待在今年剩餘時間與各位分享這些更新。

Thank you for joining us today, and we can close the call.

感謝各位今天加入我們，我們可以結束電話會議。

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation, and you may now disconnect.

各位女士、先生，今天的電話會議到此結束。感謝各位的參與，您現在可以掛線。