Alkermes Plc (ALKS) 2025 Q3 法說會逐字稿

Greetings, and welcome to the Alkermes third quarter 2025 financial results conference call. My name is Rob and I'll be your operator for today's call.

各位好，歡迎參加 Alkermes 2025 年第三季財務業績電話會議。我叫羅伯，今天由我來為您接聽電話。

(Operator Instructions) Please note that this conference is being recorded.

（操作員說明）請注意，本次會議正在錄音。

I will now turn the call over to Sandra Coombs, Senior Vice President of Investor Relations and Corporate Affairs. Sandy, you may now begin.

現在我將把電話交給投資者關係和企業事務高級副總裁桑德拉·庫姆斯。桑迪，你可以開始了。

Thanks, Rob. Welcome to the Alkermes plc conference call to discuss our financial results and business update for the quarter ended September 30, 2025. With me today are Richard Pops, our CEO; Blair Jackson, our Chief Operating Officer; Todd Nichols, our Chief Commercial Officer; and Joshua Reed, our Chief Financial Officer.

謝謝你，羅伯。歡迎參加 Alkermes plc 的電話會議，我們將討論截至 2025 年 9 月 30 日的季度財務業績和業務更新。今天陪同我的有：我們的執行長 Richard Pops；我們的營運長 Blair Jackson；我們的首席商務官 Todd Nichols；以及我們的財務長 Joshua Reed。

A slide presentation along with our press release, related financial tables, and reconciliations of the GAAP to non-GAAP financial measures that we'll discuss today are available on the Investor section of alkermes.com. We believe the non-GAAP financial results in conjunction with the GAAP results are useful in understanding the ongoing economics of our business. Our discussions during this conference call will include forward-looking statements, actual results could differ materially from these forward-looking statements.

今天我們將討論的幻燈片簡報、新聞稿、相關財務報表以及GAAP與非GAAP財務指標的調節表，均可在alkermes.com網站的投資者關係板塊查閱。我們認為，結合GAAP財務結果來看，非GAAP財務結果有助於我們了解公司持續經營的經濟狀況。本次電話會議的討論內容將包含前瞻性陳述，實際結果可能與這些前瞻性陳述有重大差異。

Please see slide 2 of the accompanying presentation, our press release issued this morning, and our most recent annual and quarterly reports filed with the SEC, for important risk factors that could cause our actual results to differ materially from those expressed or implied in the forward-looking statements.

請參閱隨附簡報的第 2 頁、我們今天早上發布的新聞稿以及我們向美國證券交易委員會提交的最新年度和季度報告，以了解可能導致我們的實際結果與前瞻性聲明中明示或暗示的結果存在重大差異的重要風險因素。

We undertake no obligation to update or revise the information provided on this call or in the accompanying presentation as a result of new information or future results or developments. After our prepared remarks, we will open the call for Q&A.

我們不承擔因新資訊、未來結果或發展而更新或修改本次電話會議或隨附簡報中所提供的資訊的義務。在我們發言完畢後，我們將開放問答環節。

And now I'll turn the call over to Richard for some opening remarks.

現在我將把電話交給理查德，請他致開幕詞。

That's great, Sandy. Thank you. Good morning, everyone. So Alkermes has delivered a strong third quarter. It was marked by solid commercial execution, significant progress in our development pipeline, robust financial performance, and continued execution across our strategic priorities. Today, we're raising our financial expectations for 2025, reflecting our confidence in the momentum of the business.

太好了，桑迪。謝謝。各位早安。所以，Alkermes第三季業績表現強勁。其特點是：穩健的商業執行、研發管線的重大進展、強勁的財務表現以及在各項策略重點方面的持續推進。今天，我們提高了對 2025 年的財務預期，這反映了我們對公司業務發展勢頭的信心。

Before we dive into the results for the quarter and our increased expectations for the remainder of 2025, I'd like to take a moment on the announcement we made last week regarding our proposed acquisition of Avadel Pharmaceuticals. This transaction is an important step forward in Alkermes strategic evolution for three compelling reasons.

在我們深入探討本季業績以及我們對 2025 年剩餘時間的更高預期之前，我想花點時間談談我們上周宣布的關於擬收購 Avadel Pharmaceuticals 的消息。此次交易是 Alkermes 策略發展進程中的重要一步，原因有三。

First, we gain an FDA-approved medicine with significant growth potential. LUMRYZ is the first and only FDA-approved once-at-bedtime oxybate for the treatment of cataplexy or excessive daytime sleepiness in patients seven years or older with narcolepsy. It has already shown strong market uptake since launch. In 2025, it's expected to generate between $265 million and $275 million in net revenue. Once the transaction is complete, it will immediately diversify our commercial portfolio and strengthen our profitability.

首先，我們獲得了一種獲得 FDA 批准且具有巨大成長潛力的藥物。LUMRYZ 是首個也是唯一一個獲得 FDA 批准的睡前服用一次的羥丁酸類藥物，用於治療 7 歲及以上患有發作性睡病的患者的猝倒症或白天過度嗜睡。自上市以來，該產品已展現出強勁的市場接受度。預計到 2025 年，該公司將產生 2.65 億美元至 2.75 億美元的淨收入。交易完成後，將立即實現我們商業組合的多元化，並增強我們的獲利能力。

Second, the acquisition will accelerate our commercial entry into the sleep medicine market. It will provide a well-established foundation for the potential launch of alixorexton, our promising orexin 2 receptor agonist in development for narcolepsy and idiopathic hypersomnia. Avadel is a recognized leader in sleep medicine and has successfully built and scaled a high-performing commercial organization.

其次，此次收購將加速我們進軍睡眠醫學市場的商業化。這將為我們很有前景的食慾素 2 受體激動劑 alixorexton 的潛在上市奠定良好的基礎，該藥物目前正在開髮用於治療發作性睡病和特發性嗜睡症。Avadel 是睡眠醫學領域公認的領導者，並已成功建立和擴大了高效的商業組織。

With positive Phase 2 data for alixorexton and narcolepsy type 1 now in hand, data from Vibrance-2 and NT2 that we expect to report in November, and plans to initiate a global Phase 3 program early next year, we've reached a new level of conviction in the potential of our orexin platform.

鑑於我們已經掌握了 alixorexton 和 1 型嗜睡症的積極 2 期數據，預計將在 11 月公佈 Vibrance-2 和 NT2 的數據，併計劃於明年初啟動全球 3 期項目，我們對食慾素平台的潛力有了新的信心。

And third, the financial strength of the combined company will enhance our ability to support a diversified development strategy in sleep disorders. This will include alixorexton, as well as our additional orexin 2 receptor agonist candidates, ALKS 4510 and 4510 7290, which recently entered the clinic.

第三，合併後公司的財務實力將增強我們支持睡眠障礙領域多元化發展策略的能力。這將包括 alixorexton，以及我們其他的食慾素 2 受體激動劑候選藥物 ALKS 4510 和 4510 7290，它們最近已進入臨床階段。

Avadel development pipeline also has the potential to broaden our offerings for the sleep community with an ongoing Phase 3 study of LUMRYZ idiopathic hypersomnia and valiloxybate, a no-salt oxybate candidate in early stage development.

Avadel 的研發管線還有可能透過正在進行的 LUMRYZ 特發性嗜睡症 3 期研究和處於早期研發階段的無鹽羥丁酸候選藥物 valiloxybate，來擴大我們為睡眠領域提供的產品。

The proposed acquisition reinforces our commitment to neuroscience. It gives us additional scale and builds on our legacy of innovation in complex psychiatric and neurological disorders. The transaction is a compelling opportunity to accelerate our growth trajectory and is squarely aligned with our financial and strategic priorities. Upon closing, which we currently expect in Q1, we'll be able to provide more color on our expectations for the combined business.

此次擬議收購鞏固了我們對神經科學領域的投入。它為我們帶來了更大的規模，並鞏固了我們在複雜精神和神經疾病領域的創新傳統。此次交易為我們加速成長提供了絕佳的機會，並且完全符合我們的財務和策略重點。交易完成後（我們目前預計在第一季完成），我們將能夠更詳細地說明我們對合併後業務的預期。

So with that as an intro, I'll turn it over to Joshua, who will walk through our third quarter financial results.

那麼，介紹完畢，接下來我將把麥克風交給約書亞，他將為大家介紹我們第三季的財務表現。

Thank you, Richard. I'm pleased to join you today for my first earnings call as Chief Financial Officer of Alkermes. I'm excited to be part of a company with a strong financial foundation, a clear strategic vision, and a deep commitment to delivering value for shareholders while advancing innovative medicines that have the potential to make a meaningful difference for patients.

謝謝你，理查。今天我很高興能以 Alkermes 財務長的身份參加我的第一次財報電話會議。我很高興能加入一家財務基礎雄厚、戰略願景清晰、致力於為股東創造價值並推進創新藥物研發的公司，這些藥物有可能為患者帶來有意義的改變。

Since joining, I spent time getting to know our teams, our operations, and our financial priorities. I've been impressed by the discipline and focus that drive our performance, and I look forward to building on that momentum.

加入公司後，我花了很多時間了解我們的團隊、營運狀況和財務重點。我對我們展現的自律和專注印象深刻，並期待在此基礎上再創佳績。

Now, turning to our financial results. Our third quarter results were strong, reflecting continued commercial and operational execution. Financially, the year's tracking ahead of our expectations, and based on our performance through the first nine months, we are raising our full year 2025 guidance today.

現在，讓我們來看看我們的財務表現。第三季業績表現強勁，反映了我們持續的商業和營運執行力。財務方面，今年的業績超出預期，基於前九個月的表現，我們今天上調了 2025 年全年業績預期。

For the third quarter, we generated total revenues of $394.2 million, driven primarily by our portfolio proprietary products, which generated net sales of $317.4 million, reflecting 16% year-over-year growth. These results were driven by strong underlying demand, which Todd will address in his remarks, and gross net favorability, primarily related to Medicaid utilization rates, which drove a one-time gross net benefit of approximately $8 million for VIVITROL and approximately $5 million for ARISTADA.

第三季度，我們實現了總營收 3.942 億美元，主要得益於我們自有產品組合的淨銷售額 3.174 億美元，年增 16%。這些結果是由強勁的潛在需求（托德將在演講中談到這一點）和總淨收益（主要與醫療補助使用率有關）推動的，這為 VIVITROL 帶來了約 800 萬美元的一次性總淨收益，為 ARISTADA 帶來了約 500 萬美元的一次性總淨收益。

As we move into the fourth quarter, we expect Q4 net sales from this portfolio in the range of $300 million to $320 million. Manufacturing and royalty revenues were $76.8 million for the third quarter, including revenues of $35.6 million from VUMERITY and $30.2 million from the long-acting INVEGA products.

進入第四季度，我們預計該產品組合第四季的淨銷售額將在 3 億至 3.2 億美元之間。第三季製造和​​特許權使用費收入為 7,680 萬美元，其中包括 VUMERITY 帶來的 3,560 萬美元收入和長效 INVEGA 產品帶來的 3,020 萬美元收入。

Turning to expenses. Cost of goods sold were $51.6 million, which compared favorably to $63.1 million for Q3 last year, primarily reflecting efficiencies falling in the field of our Athlone-based manufacturing business last year. R&D expenses were $81.7 million, compared to $59.9 million for Q3 last year, reflecting investments in the Vibrance Phase 2 studies of alixorexton across narcolepsy and idiopathic hypersomnia, and first-in-human studies and development efforts for our next orexin 2 receptor agonist candidates, ALKS 4510 and ALKS 7290.

接下來談談費用。銷售成本為 5,160 萬美元，與去年第三季的 6,310 萬美元相比有所下降，這主要反映了去年我們位於阿斯隆的製造業務效率的提高。研發費用為 8,170 萬美元，而去年第三季為 5,990 萬美元，這反映了對 alixorexton 治療嗜睡症和特發性嗜睡症的 Vibrance 2 期研究的投資，以及對我們下一個食慾素 2 受體激動劑候選藥物 ALKS 4510 和 ALKS 7290 的首次人體研究和開發工作。

SG&A expenses were $171.8 million, compared to $150.4 million for Q3 last year, reflecting the expansion of our psychiatry field organization earlier this year, and promotional activities related to LYBALVI. In Q4, we expect a modest increase in SG&A, primarily reflecting activities related to the Avadel transaction. This performance generated strong profitability of GAAP net income of $82.8 million, EBITDA of $96.9 million, and adjusted EBITDA of $121.5 million in the third quarter.

銷售、一般及行政費用為 1.718 億美元，而去年第三季為 1.504 億美元，這反映了我們今年早些時候精神病學領域組織的擴張以及與 LYBALVI 相關的推廣活動。第四季度，我們預計銷售、管理及行政費用將略有增加，主要反映與 Avadel 交易相關的活動。這項業績帶來了強勁的獲利能力，第三季 GAAP 淨收入為 8,280 萬美元，EBITDA 為 9,690 萬美元，調整後 EBITDA 為 1.215 億美元。

As we look ahead, based on our strong commercial performance and momentum through the first nine months of the year, we are on track to deliver record revenues from our portfolio of proprietary products in 2025. As a result, we are raising our 2025 full-year guidance to reflect our current expectations of total revenues of $1.43 billion to $1.49 billion, GAAP net income of $230 million to $250 million, EBITDA of $270 million to $290 million, and adjusted EBITDA of $365 million to $385 million. Our full expectations are outlined in the press release issued this morning.

展望未來，基於我們強勁的商業表現和今年前九個月的發展勢頭，我們預計在 2025 年實現我們專有產品組合的收入創歷史新高。因此，我們將 2025 年全年業績預期上調，以反映我們目前的預期：總收入為 14.3 億美元至 14.9 億美元，GAAP 淨收入為 2.3 億美元至 2.5 億美元，EBITDA 為 2.7 億美元至 2.9 億美元，調整後 EBITDA 為 3.3.85 億美元。我們的全部預期已在今天早上發布的新聞稿中概述。

Turning to our balance sheet, we entered the quarter in a strong position with $1.14 billion in cash and total investments. For the acquisition of Avadel, we will use cash from our balance sheet in conjunction with bank debt to finance the transaction. As we close the transaction and finalize the financing, we will be in a position to provide more details.

從資產負債表來看，我們本季伊始財務狀況良好，擁有 11.4 億美元的現金和總投資。為了收購 Avadel，我們將使用資產負債表中的現金以及銀行貸款來為交易融資。待交易完成、融資最終落實後，我們將能提供更多細節。

Taking a step back, Alkermes is one of the few biopharmaceutical companies that have successfully transitioned into a fully integrated, profitable commercial organization with an exciting development pipeline. I stepped into this role at a time when the company is operating from a position of financial strength with a clear growth trajectory and near-term opportunities with the potential to drive meaningful value for shareholders.

從更宏觀的角度來看，Alkermes 是少數幾家成功轉型為完全一體化、盈利的商業組織並擁有令人振奮的研發管線的生物製藥公司之一。我接任這個職位時，公司財務狀況穩健，成長軌跡清晰，近期也有機會為股東創造有意義的價值。

I'm energized by the opportunity to help shape that next phase of our growth. Working closely with the rest of the leadership team to support our strategic priorities and drive long-term value creation. I look forward to engaging with many of you in the weeks ahead and to contributing to the continued success of Alkermes.

有機會參與塑造我們發展的下一個階段，我感到非常振奮。與領導團隊其他成員緊密合作，支持我們的策略重點，並推動長期價值創造。我期待在接下來的幾週與大家交流，並為 Alkermes 的持續成功做出貢獻。

With that, I will turn the call to Todd for a review of the proprietary portfolio.

接下來，我將把電話轉給托德，讓他對專有投資組合進行審查。

Thank you, Joshua. And good morning, everyone. In the first three quarters of the year, we executed with discipline against our targeted growth initiatives. The focus drove strong, consistent performance across our three proprietary brands, underscoring the strength of our commercial strategy and our capabilities. We're encouraged by the momentum we've built and remain confident in our ability to carry it forward.

謝謝你，約書亞。大家早安。今年前三個季度，我們嚴格執行了既定的成長計畫。這項重點推動了我們三大自有品牌的強勁、穩定的業績成長，凸顯了我們商業策略和能力的優勢。我們對目前取得的進展勢頭感到鼓舞，並對我們繼續保持這種勢頭的能力充滿信心。

In the third quarter, we recorded net sales from our proprietary product portfolio of $317.4 million, reflecting 16% year-over-year growth. We drove strong in-market demand across VIVITROL, ARISTADA, and LYBALVI. Starting with VIVITROL, net sales in the third quarter were $121.1 million. VIVITROL performance continued to be driven by growth in the alcohol dependence indication market and our ability to capitalize on highly localized market dynamics in certain states and payer systems. For the full year 2025, we now expect VIVITROL net sales in the range of $460 million to $470 million, compared to our prior expectation of $440 million to $460 million.

第三季度，我們自有產品組合的淨銷售額為 3.174 億美元，較去年同期成長 16%。我們推動了 VIVITROL、ARISTADA 和 LYBALVI 的強勁市場需求。以 VIVITROL 為例，第三季淨銷售額為 1.211 億美元。VIVITROL 的業績持續成長，這主要得益於酒精依賴適應症市場的成長，以及我們能夠利用某些州和支付系統的高度本地化的市場動態。我們現在預計 VIVITROL 在 2025 年全年的淨銷售額將在 4.6 億美元至 4.7 億美元之間，而我們先前的預期為 4.4 億美元至 4.6 億美元。

Turning to our psychiatry franchise. The expansion of our psychiatry sales force earlier this year with a key strategic initiative designed to enhance our competitive share voice. With our expanded footprint, we have been able to significantly increase the frequency of our call volume for high-priority prescriber targets across LYBALVI and ARISTADA. This increased share voice, along with strong execution, has driven increased breadth of prescribers for both brands.

轉向我們的精神科特許經營業務。今年早些時候，我們透過一項旨在增強我們競爭市場份額的關鍵策略舉措，擴大了我們的精神科銷售團隊。隨著我們業務範圍的擴大，我們能夠顯著提高對 LYBALVI 和 ARISTADA 高優先處方醫生目標的呼叫頻率。市場份額的提升，加上強有力的執行，推動了這兩個品牌處方醫生數量的成長。

For the ARISTADA product family, in the third quarter, net sales were $98.1 million. Leading indicators related to underlying demand were encouraging with increased prescriber breadth and strong new-to-brand prescriptions during the quarter. For the full year 2025, we now expect ARISTADA net sales in the range of $360 million to $370 million, compared to our prior expectation of $335 million to $355 million.

在第三季度，ARISTADA 產品系列的淨銷售額為 9,810 萬美元。與潛在需求相關的領先指標令人鼓舞，本季處方醫生覆蓋範圍擴大，新品牌處方量強勁成長。我們現在預計 ARISTADA 2025 年全年淨銷售額將在 3.6 億美元至 3.7 億美元之間，而我們先前的預期為 3.35 億美元至 3.55 億美元。

Turning to LYBALVI. Net sales grew 32% year over year to $98.2 million. Underlying TRx growth was 25% year over year, driven by new patient starts and prescriber breadth. Growth to net adjustments were approximately 28% in the third quarter. For the full year, we now expect LYBALVI net sales in the range of $340 million to $350 million, compared to our prior expectation of $320 million to $340 million.

轉向 LYBALVI。淨銷售額年增 32%，達到 9,820 萬美元。受新患者開診量和處方醫生數量增加的推動，TRx 的基礎成長率年增 25%。第三季淨調整成長率約為 28%。我們現在預計 LYBALVI 全年淨銷售額將在 3.4 億美元至 3.5 億美元之間，而我們之前的預期為 3.2 億美元至 3.4 億美元。

Across the portfolio, we are pleased with our performance through the first three quarters of the year and enter the final stretch of the year with strong momentum and a clear focus on delivering against our full-year objectives.

總體而言，我們對今年前三個季度的業績感到滿意，並帶著強勁的勢頭和明確的目標進入今年的最後階段，力爭實現全年目標。

With that, I will pass the call back to Rich.

這樣，我就把電話轉回給里奇了。

Thank you, Todd. Well done. I think you can see from the results that the company is performing well across each of the key aspects of our business. During the quarter, our commercial teams delivered strong operational financial performance, and our R&D teams made major strides in advancing or expanding development pipeline.

謝謝你，托德。做得好。從結果可以看出，公司在業務的各個關鍵方面都表現出色。本季度，我們的商業團隊取得了強勁的營運財務業績，我們的研發團隊在推進或擴大研發管線方面取得了重大進展。

So I want to make comments about both aspects of the business. First, commercial. We enter the final quarter of the year ahead of plan and with good momentum into year-end. Over many years, we developed capabilities necessary to operate in challenging payer and policy environments. By design, we manufacture our proprietary products in the United States, and we do not commercialize these products outside the US. We are growing our business by growing demand based on the clear clinical attributes of our medicines and maintaining a disciplined contracting strategy consistent with our view of their significant value.

所以我想就業務的兩個方面發表一些看法。首先是商業方面。我們提前完成了今年的最後一個季度，並保持著良好的勢頭進入年底。多年來，我們培養了在充滿挑戰的支付方和政策環境中運作所需的能力。我們自主研發的產品均在美國生產，我們不在美國以外地區銷售這些產品。我們透過增加基於我們藥品明確臨床特性的需求來發展業務，並保持與我們對藥品重大價值的看法相一致的嚴謹的合約策略。

Now, R&D. Our portfolio of orexin 2 receptor agonists is advancing rapidly, led by alixorexton. The first Phase 2 dataset of alixorexton was presented at World Sleep in September. In the Vibrance-1 study, alixorexton demonstrated compelling therapeutic benefits in patients with narcolepsy type 1 with a profound effect on excessive daytime sleepiness and cataplexy, along with a generally well-tolerated safety profile.

現在，研發。以 alixorexton 為首的食慾素 2 受體激動劑產品組合正在快速發展。alixorexton 的首個第二階段資料集已於 9 月在世界睡眠大會上公佈。在 Vibrance-1 研究中，alixorexton 對 1 型嗜睡症患者表現出顯著的治療效果，對白天過度嗜睡和猝倒有顯著療效，且安全性良好。

Taken together with the clinically meaningful improvements in fatigue and cognitive function demonstrated in the study, we believe alixorexton has the potential to transform the treatment of NT1. At World Sleep, the competitive positioning for alixorexton and NT1 also came clearly into focus.

結合研究中顯示的疲勞和認知功能方面的臨床意義的改善，我們相信 alixorexton 有潛力改變 NT1 的治療。在世界睡眠展上，alixorexton 和 NT1 的競爭定位也變得清晰。

In this large, randomized, double-blind, multi-week study, alixorexton, administered once daily across a range of doses, demonstrated new potential best-in-class features. With data from this rigorous Phase 2 study now in hand, we're confident in the profile of alixorexton and NT1, and we're moving rapidly to initiate the Phase 3 registrational program in the first quarter of next year.

在這項大型、隨機、雙盲、多週的研究中，每天一次、不同劑量的 alixorexton 表現出了新的潛在同類最佳特性。現在，我們已經掌握了這項嚴格的 2 期研究的數據，對 alixorexton 和 NT1 的特性充滿信心，並且我們正在迅速推進，計劃在明年第一季啟動 3 期註冊計劃。

We expect to be first to market narcolepsy type 2 and idiopathic hypersomnia. We completed enrollment in Vibrance-2 in patients with narcolepsy type 2 toward the end of the summer, and we expect to report top-line data in November.

我們有望率先將 2 型嗜睡症和特發性嗜睡症的治療產品推向市場。我們在夏季末完成了 Vibrance-2 研究中 2 型嗜睡症患者的招募工作，預計將於 11 月公佈初步數據。

In idiopathic hypersomnia, Vibrance-3 is enrolling well, and we expect data from that study in mid-2026. Like Vibrance-1, these are both large, well-powered, Phase 2 studies designed to provide substantial data sets informing potential Phase 3 development. We are building a significant body of clinical data that deepens our understanding of orexin biology and its therapeutic potential in central orders of hypersomnolence and beyond.

在特發性嗜睡症方面，Vibrance-3 研究正在順利招募患者，我們預計將在 2026 年年中獲得該研究的數據。與 Vibrance-1 一樣，這兩項研究都是規模龐大、樣本量充足的 2 期研究，旨在提供大量數據，為潛在的 3 期開發提供資訊。我們正在累積大量的臨床數據，以加深我們對食慾素生物學及其在中樞性嗜睡症及其他疾病中的治療潛力的理解。

Equally important, the Phase 2 studies are yielding key learnings related to study design and implementation that we believe will be invaluable for Phase 3 and help support alixorexton’s competitive position in narcolepsy. Beyond alixorexton and sleep disorders, additional candidates from our portfolio of orexin 2-receptor agonists are advancing well.

同樣重要的是，2 期研究正在產生與研究設計和實施相關的關鍵經驗，我們相信這些經驗對於 3 期研究將是寶貴的，並有助於支持 alixorexton 在嗜睡症領域的競爭地位。除了 alixorexton 和睡眠障礙之外，我們產品組合中的其他食慾素 2 受體激動劑候選藥物也進展順利。

ALKS 4510 is in the clinic and progressing quickly through single and multiple ascending-dose studies in healthy volunteers. We expect to complete this Phase 1 work early next year and move quickly into proof-of-concept studies in the disease areas that we plan to pursue.

ALKS 4510 正在進行臨床試驗，並在健康志願者中透過單次和多次遞增劑量研究快速取得進展。我們預計將於明年初完成第一階段的工作，並迅速進入我們計劃開展的疾病領域的概念驗證研究。

For ALKS 7290, we have filed the IND and recently initiated our first in-human study. Across our orexin development programs, we have demonstrated in clinical or preclinical models that orexin 2 receptor agonists may have powerful effects, not only on wakefulness, but also across domains related to fatigue, cognition, attention, and mood. We look forward to sharing more on both of these candidates next year as they complete their Phase 1 healthy volunteer studies.

對於 ALKS 7290，我們已經提交了 IND 申請，並且最近啟動了我們的第一次人體研究。在我們的食慾素開發計畫中，我們已經在臨床或臨床前模型中證明，食慾素 2 受體激動劑不僅對清醒狀態有強大的作用，而且對疲勞、認知、注意力和情緒等相關領域也有強大的作用。我們期待明年與大家分享更多關於這兩位候選人的信息，屆時他們將完成第一階段健康志願者研究。

So to wrap up, the third quarter was a clear demonstration of Alkermes strong execution, commercial momentum, and scientific leadership. We continue to operate from a position of financial strength as we advance our pipeline and generate a growing body of data and insights that inform our strategy and reinforce our conviction in the opportunities ahead. With disciplined focus and a commitment to innovation and the patience we serve, we're well-positioned to deliver long-term value for our shareholders. So we look forward to sharing our progress.

綜上所述，第三季充分展現了 Alkermes 強大的執行力、商業動能和科學領導地位。我們憑藉雄厚的財務實力繼續運營，推進專案進展，並不斷累積數據和見解，這些數據和見解為我們的策略提供信息，並增強我們對未來機會的信心。憑藉著嚴謹的專注、對創新的執著以及我們所展現的耐心，我們有能力為股東創造長期價值。我們期待與大家分享我們的進展。

With that, I'll turn the call back to Sandy to manage the Q&A.

接下來，我將把電話轉回給桑迪，由她來主持問答環節。

Thanks, Rich. Rob, we'll open the call now for Q&A, please.

謝謝你，里奇。羅布，現在開始問答環節。

(Operator Instructions) Marc Goodman, Leerink Partners.

（操作說明）Marc Goodman，Leerink Partners。

Yeah. Can you talk about LYBALVI just a little bit? It seemed to be a lot stronger than expected and the gross net seemed to be a little lower than expected. We were expecting that to kind of creep up some. Just give us a sense of what's happening with the product and just how you're thinking about gross to net. into the next year?

是的。能稍微談談LYBALVI嗎？實際表現似乎比預期好得多，但毛利似乎比預期要低一些。我們預料到這種情況會逐漸加劇。請您簡單介紹一下產品目前的狀況，以及您對明年毛利和淨利的預期？

Yeah. Absolutely, Marc. This is Todd. Yeah. We're really pleased with performance for Q3. As I said in my prepared remarks, mention of our psychiatry footprint really drove a strong share of voice in the quarter. We were able to significantly increase our call volume, which was our strategic plan. We did that in Q3. We believe that momentum will carry into Q4. And so the result of that is we saw year over year TRx growth of about 25%.

是的。當然，馬克。這是托德。是的。我們對第三季的業績非常滿意。正如我在準備好的演講稿中所說，提及我們在精神病學領域的影響力，確實在本季度獲得了很高的關注度。我們成功地大幅提高了呼叫量，這正是我們的策略計畫。我們在第三季完成了這項工作。我們相信這股動能將延續到第四季。因此，我們看到 TRx 年成長約 25%。

But what's even more encouraging is we saw new patients start year over year. NBRx has increased almost 16%. So the underlying demand is really encouraging and we believe that's a really direct reflection of the expansion of our sales force. So for context, breadth of prescribing over the quarter increased 7%. So that's two consecutive quarters, Q2 and Q3, we saw a strong breadth of prescribing.

但更令人鼓舞的是，我們看到每年都有新患者加入。NBRx 成長了近 16%。因此，潛在需求非常令人鼓舞，我們相信這直接反映了我們銷售團隊的擴張。因此，作為背景，本季處方範圍擴大了 7%。所以連續兩個季度（第二季和第三季），我們都看到了處方量的大幅成長。

To your question on gross to net, gross to net was a little bit lower in the quarter than from Q2. That's the result of just as deductible resets throughout the year, lower co-pay utilization, some small little dynamics like that actually had a lower gross to net for the quarter.

關於您提出的毛利與淨利的問題，本季的毛利與淨利比第二季略低。這是由於全年免賠額重置、共同支付使用率降低等一些小因素造成的，實際上導致該季度毛利與淨利之比下降。

And Marc, it's Rich. I'll just add and Todd can expand on it. But the story about LYBALVI over time in the marketplace, other than just our strong commercial execution, is its efficacy. And that efficacy message is resonating, and I think it's supported now by multiyear data in the real world.

還有馬克，我是里奇。我補充一下，Todd 可以補充完善。但隨著時間的推移，LYBALVI 在市場上的故事，除了我們強大的商業執行力之外，就是它的療效。這種功效訊息引起了共鳴，我認為現在現實世界中的多年數據也支持了這一點。

How do we think about gross to net into next year?

我們如何考慮明年的毛利潤到淨利的變化？

So we're not going to provide any guidance today, Marc, for next year. We do expect that going into Q4 that the typical seasonal patterns would show up. So we do expect a little bit of expansion of gross to net in Q4. But we'll give you a full year guide in February.

所以，馬克，今天我們不會就明年的情況提供任何指導。我們預計進入第四季後，典型的季節性模式將會出現。因此，我們預計第四季度毛利潤與淨利潤之比會略有增長。但我們會在二月提供一份完整的年度指南。

Okay, thanks.

好的，謝謝。

David Hoang, Deutsche Bank.

David Hoang，德意志銀行。

Hi, thanks for taking the question. So I just wanted to ask about I guess, expectations once the NT2 alixorexton data are in hand, how does that inform the next steps with the FDA and when will we know more about the Phase 3 program in design? And then maybe just a follow-up on VIVITROL, just kind of the expectations heading into Q4 for that product? Thank you.

您好，感謝您回答這個問題。所以我想問一下，一旦 NT2 alixorexton 的數據出來，大家會有什麼預期？這些數據將如何影響與 FDA 的下一步合作？我們什麼時候才能了解更多關於 3 期臨床試驗設計的資訊？然後或許可以跟進 VIVITROL，談談該產品在第四季的預期？謝謝。

David, this is Rich, I'll take the first and then Todd can answer on VIVITROL. So we expect that we're on track for data from the NT2 study in November. And as we've said along, when we get those data in hand, that coupled with a Vibrance-1 NT1 data will comprise the package for our end of Phase 2 meeting with FDA. So we'll request that meeting as soon as we get the NT2 data. We'll have that meeting and then we'll launch the Phase 3 program is our expectation early next year. Go ahead, Todd.

David，我是 Rich，我先回答第一個問題，然後 Todd 可以回答關於 VIVITROL 的問題。因此，我們預計 NT2 研究的數據將在 11 月按計劃公佈。正如我們之前所說，當我們拿到這些數據後，再加上 Vibrance-1 NT1 數據，將構成我們與 FDA 舉行的 2 期臨床試驗結束會議的全部內容。所以，一旦我們拿到 NT2 數據，就會立即提出召開會議的請求。我們將召開那次會議，然後我們預計將於明年初啟動第三階段計畫。請繼續，托德。

Yeah. In terms of VIVITROL for the fourth quarter, I think the basis of that is what we saw in Q3. We saw strong AD demand. AD sales continue to drive the substantial majority of the brand. We hear very encouraging feedback from the market from HCPs and patients.

是的。就第四季的 VIVITROL 而言，我認為其基礎是我們在第三季看到的情況。我們看到了強勁的廣告需求。廣告銷售額仍是該品牌收入的主要來源。我們從醫療保健專業人員和患者那裡收到了非常令人鼓舞的市場回饋。

So our expectation is that we would continue to see AD growth going to the fourth quarter. I think it's also just important to keep in mind that this is a mature product. So we think it will perform like a mature product, but our focus is really driving AD sales in.

因此，我們預計第四季度 AD 將繼續保持成長。我認為同樣重要的是要記住，這是一個成熟的產品。所以我們認為它會像成熟產品一樣運行，但我們的重點實際上是推動廣告銷售。

Umer Raffat, Evercore ISI.

Umer Raffat，Evercore ISI。

Hi guys, thanks for taking my question. I just wanted to dial in on the NT2 study a little bit. Could you perhaps lay out for us your expectation of how much of an MWT benefit is reasonable to expect, knowing there's a bit of tax flexes off of single-dose work in Phase 1.

大家好，感謝你們回答我的問題。我只是想稍微深入研究一下NT2的研究。您能否為我們詳細說明一下，考慮到 1 期臨床試驗中單劑量疫苗研發存在一定的稅收優惠，您對 MWT 帶來的收益預期應該有多大？

But on the flip side, patients are starting off at 10 to 12 minutes at baseline. So how much MWT improvements are you expecting. And then also any broad parameters around what do you know as of right now on blinded safety for NT2? Thank you very much.

但另一方面，患者的基線起始時間為 10 到 12 分鐘。那麼，您預計 MWT 會有多大的改進？此外，您目前對 NT2 的盲法安全性有哪些大致了解？非常感謝。

Umer, it's Rich, I won't comment on any of the blinded data. We'll get the full data set here just in a matter of weeks. So we'll look at the data in the aggregate in a large multiweek randomized, placebo-controlled study, the blinded information is only -- is not particularly useful to us. So we'll look forward to seeing the whole data set right away.

烏默，我是里奇，我不會對任何匿名數據發表評論。我們只需幾週就能拿到完整的資料集。因此，我們將從一項大型、多週的隨機、安慰劑對照研究中匯總數據，盲法資訊對我們來說並不特別有用。所以我們期待盡快看到完整的資料集。

Our expectation is that based on the Phase 1b study, is that we know that orexin 2 receptor agonist from that study can drive wakefulness in patients with NT2 and NIH. But we really don't have a numerical threshold at the outset because we also expect a lot more variability in the patient population.

根據第 1b 期研究，我們預期，該研究中的食慾素 2 受體激動劑可以促進 NT2 和 NIH 患者的清醒狀態。但我們一開始並沒有設定一個數值閾值，因為我們也預期患者群體會有更大的差異性。

So from a Phase 2 perspective, what we're looking for is we've identified a range of doses like we did in the NT1 study. What we'd like to see is the safety tolerability profile across that range of doses and clear evidence of efficacy across the various efficacy parameters, all to inform our dose selection for Phase 3. So that's the goal.

因此，從 2 期臨床試驗的角度來看，我們正在尋找的是，我們已經確定了一系列劑量，就像我們在 NT1 研究中所做的那樣。我們希望看到的是該劑量範圍內的安全性耐受性概況，以及在各種療效參數方面明確的療效證據，所有這些都將為我們 3 期臨床試驗的劑量選擇提供依據。這就是目標。

If we can come out of the NT2 study with clear evidence of safety, tolerability, and efficacy in a design for Phase 3, we think we're going to be the first to market in NT2. And the same thing applies for IH. And this is the virtue, by the way, of running these large Phase 2 studies. When you're talking about cohorts of 90 patients or so over multiple weeks, and remember, it's not just a six-week or five-week double wind period. It's also the extension period where we have dose variability in selection for patients.

如果我們能夠從 NT2 研究中獲得明確的安全、耐受性和有效性證據，並設計出 3 期臨床試驗方案，我們認為我們將成為第一個將 NT2 產品推向市場的公司。同樣的情況也適用於IH。順便說一句，這就是進行這些大型二期臨床試驗的好處。當你在談論持續數週的 90 名左右患者的隊列時，請記住，這不僅僅是六週或五週的雙倍放屁期。這也是延長治療期，期間我們會根據患者狀況選擇不同的劑量。

So between these 2 phases, we just learned a tremendous amount about patient preference as well as dose response. And that all goes into the calculus for Phase 3.

因此，在這兩個階段之間，我們對患者的偏好以及劑量反應有了非常深入的了解。所有這些都納入了第三階段的計算之中。

Thank you.

謝謝。

Paul Matteis, Stifel.

Paul Matteis，Stifel。

Just to piggyback off that, can you confirm what details you'll give us in the top line release? Will we know the actual effect size? Or are you going to be saving some of this for a medical meeting?

順便問一下，能否確認一下，在主要版本中會透露哪些細節？我們能知道實際效應量嗎？還是你打算把其中一部分留著參加醫學會議？

And then on the safety point, how are you thinking now looking ahead as to whether you might employ some sort of titration to try to attenuate certain side effects given that in the OLE and the NT1 study, we weren't really seeing much in the way of new onset visual AEs or things like that?

那麼，關於安全性方面，鑑於在 OLE 和 NT1 研究中，我們並沒有看到太多新的視覺不良事件或其他類似情況，您現在考慮是否採用某種滴定方法來嘗試減輕某些副作用？

Thanks so much.

非常感謝。

Morning, Paul. So yeah, we have a good sense of how we're going to provide the top line data, you'll see that in the next few weeks. What you learn from the Vibrance-1? Probably, there's a lot of data that comes out of these studies. So what we'll do is as soon as we get the data, we'll start submitting the abstracts for the various medical meetings as they roll into 2026.

早安，保羅。是的，我們已經大致確定瞭如何提供主要數據，您將在接下來的幾週內看到。從 Vibrance-1 中你學到了什麼？這些研究可能會產生大量數據。所以，一旦我們拿到數據，我們就會開始向 2026 年即將舉行的各種醫學會議提交摘要。

But you can expect a fair amount of data coming out of the top line, we have a good sense of the structure of it, and you'll see that in relatively short order. We have made a lot of decisions following Vibrant-1 about the structure of the dosing in Phase 3. We're going to keep most of that proprietary right now because we feel like there are some real learnings.

但您可以期待從頂層資料中獲得相當多的信息，我們對它的結構有很好的了解，您很快就會看到這一點。在 Vibrant-1 試驗之後，我們對第 3 期臨床試驗的給藥方案結構做出了許多決定。目前我們打算對大部分內容保密，因為我們覺得其中包含一些真正有價值的經驗。

Some of them probably you can think through derives from the comment that you made is that we really saw a very, very low incidence of new onset adverse events for patients who had already been exposed to alixorexton in the double-blind period. So all that information from Vibrance-1 has been put into our modeling and I think we've settled on our Phase 3 design, and you'll see that when the study gets underway.

其中一些可能源自於您先前的評論，那就是我們在雙盲期已經接觸過阿利索雷斯頓的患者中，確實觀察到新發不良事件的發生率非常非常低。因此，Vibrance-1 的所有資訊都已納入我們的模型中，我認為我們已經確定了 3 期設計，當研究開始時，您就會看到這一點。

Great, thank you.

太好了，謝謝。

Akash Tewari, Jefferies.

阿卡什‧特瓦里，傑富瑞集團。

This is Manoj for Akash. Just two questions. When you release the top line Vibrance-2 data, will you be releasing data points over time like four weeks and eight weeks, because both TRK-994 and 861NT2 data showed some deterioration of efficacy, primarily in MWT going from four weeks to eight weeks. Do you see any biological rationale for this? Or is it just like a noise related to a small number there?

這是Manoj給Akash的問候。就兩個問題。當您發布 Vibrance-2 的頂級數據時，是否會發布一段時間內的數據點，例如四周和八週的數據點？因為 TRK-994 和 861NT2 的數據都顯示療效有所下降，主要是 MWT 從四周到八週的療效下降。你認為這在生物學上有什麼合理解釋嗎？或者它只是與某個小數字相關的噪音？

And also, do we expect a dose response in Vibrance-2 in terms of ESS? And also lastly, what kind of PK profile do you look for the next-gen orexin agonist? Thank you.

另外，我們是否可以預期 Vibrance-2 中 ESS 會出現劑量反應？最後，您希望下一代食慾素激動劑具有什麼樣的藥物動力學特性？謝謝。

So on the point about the tachyphylaxis that you referred to or Umer referred to as well, we don't see based on previous data, the significant evidence of tachyphylaxis or degradation in efficacy signal between 4 and 8 weeks or even 8 and 12 weeks in other data sets.

所以關於您或 Umer 提到的快速耐受性問題，根據以往的數據，我們沒有看到在其他數據集中，4 到 8 週甚至 8 到 12 週之間存在快速耐受性或療效信號下降的明顯證據。

So at the top line, I wouldn't expect all the detailed data of time course. But I just want to let you know at the outset, that's not our pretest hypothesis that we expect to see in degradation. Now to the extent that one did, one way that you could overcome it is with a range of doses. And we've always thought that having a range of doses could be a real competitive advantage in this category.

所以，總的來說，我並不期望得到所有詳細的時間序列資料。但我想一開始就告訴你們，這並不是我們預期在效能下降過程中看到的預測試假設。如果確實存在這種情況，克服它的一種方法是採用一系列劑量。我們一直認為，擁有多種劑量選擇在這個領域可以成為真正的競爭優勢。

We are hopeful to see dose response across the various efficacy measures, but we won't know until we see the data. The three doses that we modeled for NT2 were designed to give us a spectrum of dose response, but we won't know until we see the final data set. And the PK profile of -- I think you asked about the next orexin agonist, we were really not going to disclose any of the -- any of those particular attributes of the next wave of molecules coming in.

我們希望看到各種療效指標的劑量反應關係，但只有看到數據才能知道。我們為 NT2 模擬的三種劑量旨在給我們一個劑量反應譜，但只有看到最終數據集才能知道結果。至於 PK 特徵——我想你問的是下一個食慾素激動劑，我們原本並不打算透露任何——下一波分子的任何特定屬性。

I wouldn't necessarily describe it as next generation because I don't feel like they're improving necessarily on deficiencies that alixorexton has. They're just different. And so they're designed for different patient populations in different clinical settings. And as such, they share common features of potency and selectivity. And we think that's essential for interrogating circuitry in the brain, but they will be different.

我不會把它描述為下一代產品，因為我覺得它並沒有真正改善 Alixorexton 的缺點。它們只是不同而已。因此，它們是為不同臨床環境下的不同患者群體而設計的。因此，它們具有效力和選擇性的共同特徵。我們認為這對於探究大腦中的迴路至關重要，但它們會有所不同。

Thank you.

謝謝。

Joseph Thome, TD Cowen.

Joseph Thome，TD Cowen。

Hi there, good morning, and thank you for taking my question. Maybe for the NT2 data set, can you talk a little bit about the importance of also showing the benefit on the ESS? Is this important both the FDA? Or is this more of a European measure, if you can kind of put that into context a little bit?

您好，早安，感謝您回答我的問題。對於 NT2 資料集，您能否談談在 ESS 上展示效益的重要性？這對FDA來說重要嗎？或者說，這更像是歐洲措施？能否請您稍微解釋一下背景？

And then for the Phase 3 programs, can you talk a little bit about your expectation for ocular monitoring on one side of it, I could see that it would be helpful if you do see some early visual disturbances to kind of say that this was not impactful. But obviously, on the flip side, it would probably make the Phase III a little bit more complicated. So kind of your latest thoughts on that would be helpful. Thank you.

那麼對於第三階段的計劃，您能否談談您對眼部監測的期望？一方面，我認為如果確實發現了一些早期視覺障礙，那麼說明這不會造成影響，這將很有幫助。但顯然，另一方面，這可能會使第三階段變得更加複雜。所以，您對此的最新想法將很有幫助。謝謝。

Yeah, good morning, Joe. We think in the NT2 study, both MWT and ESS or Epworth Sleepiness Scale are primary endpoints. And they capture different things. The virtue of the MWT is it's sort of a numeric, quantitative assessment of the sleep latency. And ESS captures the patient experience, their self-described degree of sleepiness. And they both -- I think they both are quite important.

是的，早上好，喬。我們認為在NT2研究中，MWT和ESS（愛普沃斯嗜睡量表）都是主要終點。它們捕捉到的東西各不相同。MWT 的優點在於它能夠對睡眠潛伏期進行某種數值化、定量化的評估。ESS 能夠捕捉患者的體驗，也就是他們自己描述的困倦程度。我認為他們倆都非常重要。

And in Phase 2, we're interested in looking at where the sensitivity is, where -- what scales move the most reliably across the doses. And that includes (inaudible) cognition, fatigue, narcolepsy severity scale, global impressions, all of the endpoints that we're looking at Phase 2 because that informs your Phase 3 structure and design. So we're hoping to see signs of efficacy across all these various parameters.

在第二階段，我們感興趣的是觀察敏感性在哪裡，以及哪些尺度在不同劑量下移動最可靠。這包括（聽不清楚）認知、疲勞、嗜睡症嚴重程度量表、整體印象，以及我們在第二階段研究的所有終點，因為這會影響第三階段的結構和設計。所以我們希望在所有這些不同的參數上都能看到療效的跡象。

Phase 3, it's too early to say. Just recounting I think that in Vibrance-1, what we saw was really generally very mild, one moderate and one severe ocular in the form of blurred vision. And so it was generally very well tolerated. And that along with the rigorous ophthalmic exams that were conducted in all the patients, I think really answered the question about are there any structural issues that derive from using an orexin 2 receptor agonist.

第三階段，現在下結論還太早。我只是回顧一下，我認為在 Vibrance-1 中，我們看到的總體上是非常輕微的眼部症狀，只有一例中度眼部症狀和一例重度眼部症狀，表現為視力模糊。因此，它總體上被人們很好地接受了。再加上對所有患者進行的嚴格眼科檢查，我認為真正回答了使用食慾素 2 受體激動劑是否會引起任何結構性問題的問題。

And so I don't know the answer yet whether we'll have to do any monitoring in the Phase 3 study. We're hopefully we don't to the extent that we do, it's quite mild. But I think in some ways, that will be more of a discussion with the regulators.

因此，我還不知道在第 3 期研究中是否需要進行任何監測。希望情況不會像現在這麼嚴重，其實還算溫和。但我認為在某些方面，這更多需要與監管機構進行討論。

Thank you.

謝謝。

David Amsellem, Piper Sandler.

大衛·阿姆塞勒姆，派珀·桑德勒。

Thanks. Just a couple of quick ones on the additional orexins that are going into the clinic. And I know, Richard, you talked about properties in mood and attention. So is it safe to say that the -- at least one additional disease setting is going to be in a psychiatric setting once you move into proof-of-concept studies next year. Maybe elaborate a little more on how you're thinking about that?

謝謝。關於即將進入臨床應用的額外食慾素，這裡簡單介紹幾點。我知道，理查德，你談到了情緒和注意力方面的特質。那麼，可以肯定地說，一旦明年進入概念驗證研究階段，至少會有額外的疾病研究領域是精神病學領域。或許可以再詳細說說你​​的想法？

And then secondly, I don't know if this has been asked, but any thoughts on alixorexton outside of the United States? And what kind of discussions, if any, have you had with European regulators there? Thank you.

其次，我不知道這個問題是否有人問過，但大家對美國以外的 alixorexton 有什麼看法？那麼，您是否與歐洲監管機構進行過任何討論？如果有，討論內容是什麼？謝謝。

Morning, David. Yeah, I think we've said about the next candidates that we're interested in three broad domains: psychiatry, neurology, and interestingly, certain rare neurodevelopmental or neurodegenerative settings, where we think a significant part of the clinical precaution is excessive daytime sleepiness and done a fatigue depressed mood, things like that.

早安，大衛。是的，我想我們已經說過，對於下一批候選人，我們感興趣的領域主要有三個：精神病學、神經病學，以及一些罕見的神經發育或神經退化性疾病，我們認為在這些疾病中，臨床預防措施的一個重要方面是白天過度嗜睡、疲勞和情緒低落等等。

So we won't be more specific than that right now. But as I mentioned in the earlier remarks, our goal is as we get through the SAD/MAD to move right into those types of patient-focused studies to get signal early on and you'll -- what I'm hopeful is that by the end of 2026, people see how this program has expanded well beyond narcolepsy.

所以我們現在就不透露更多細節了。但正如我在前面提到的，我們的目標是，在完成 SAD/MAD 之後，直接進入以患者為中心的研究領域，以便儘早獲得信號，我希望到 2026 年底，人們能夠看到這個項目已經遠遠超出了嗜睡症的範疇。

And the essential prerequisite of that is getting these two candidates through their SAD/MAD credentialing them as bone of feed development candidates for these indications. That's well underway. So we're quite excited about how that's going to mature in 2026.

而實現這一目標的關鍵前提是讓這兩位候選人通過 SAD/MAD 認證，成為這些適應症的骨幹飼料開發候選人。這項工作進展順利。所以我們非常期待它在 2026 年的發展成熟。

The second question was alixorexton in ex-US. We're developing ex-US. We're running clinical trials in Europe and in Asia, and there's a strong demand, I think, for this type of product for patients around the world. So given the state of pharmaceutical pricing discussions across the world, I think it's -- we can say comfortably, we wouldn't expect to bring alixorexton to patients outside the US at significantly lower prices than in the US. But our goal is to bring this patient -- to patients in the US, in Europe as well as in Asia.

第二個問題是 alixorexton 在 ex-US。我們正在開發美國以外的市場。我們正在歐洲和亞洲進行臨床試驗，我認為，世界各地的患者對這類產品有強烈的需求。鑑於世界各地藥品定價討論的現狀，我認為我們可以比較肯定地說，我們不會指望以比美國低得多的價格將阿利索雷斯頓帶給美國以外的患者。但我們的目標是將這種疾病帶給美國、歐洲以及亞洲的患者。

Ash Verma, UBS.

阿什維爾馬，瑞銀集團。

Hi, this is [Tian] on for Ash. For NT2, how are you thinking about these patients' hypersensitivity to exogenous orexin? What's the most concrete evidence that you see why this hypersensitivity could be lower in NT2 patients versus the NT1?

大家好，我是[Tian]，替Ash為您報道。對於第 NT2 型糖尿病，您如何看待這些患者對外源性食慾素的超敏反應？您認為最確鑿的證據是什麼，可以解釋為什麼 NT2 患者的這種過敏反應可能低於 NT1 患者？

Yeah, I wouldn't describe it as hypersensitivity. I think it's the other direction. I think NT2 patients based on the data are less sensitive to orexin agonists administered exogenously. So NT1 recall is the disease, is a deficiency of orexin.

是的，我不會把它描述為過敏。我認為方向正好相反。我認為根據數據，NT2 患者對外源性給予的食慾素激動劑的敏感性較低。所以NT1記憶障礙是一種疾病，是食慾素缺乏症。

So in NT1 patients, small doses are driving significant efficacy benefits as low as 1 milligram in our hands with alixorexton, we've shown meaningful changes in wakefulness. Whereas in NT2 patients, and we know this from our Phase Ib study, you can drive higher doses in order to elicit more wakefulness. As well as they tolerate higher doses before you see adverse events.

因此，在 NT1 患者中，小劑量即可帶來顯著的療效，在我們看來，使用 alixorexton 時，低至 1 毫克的劑量就能顯著改善患者的清醒狀態。而對於 NT2 患者，我們從 Ib 期研究中得知，可以透過增加劑量來引起更強烈的清醒感。而且它們能耐受更高的劑量，才會出現不良反應。

So the basic hypothesis going into the NT2 and IH studies is that there's a frame shift, there's a dose response curve shift to the right. so that you need more alixorexton in order to drive wakefulness and patients will tolerate more alixorexton before seeing adverse events.

因此，NT2 和 IH 研究的基本假設是存在框架偏移，即劑量反應曲線向右偏移。這意味著需要更多的阿利索雷斯頓才能使患者保持清醒，並且患者在出現不良反應之前能夠耐受更多的阿利索雷斯頓。

Thank you.

謝謝。

Leonid Timashev, RBC Capital Markets.

列昂尼德‧蒂馬舍夫，加拿大皇家銀行資本市場。

Hey, thanks for taking my question. I just want to ask how you're thinking about the NT2 versus IH population and sort of the differences in your ability to actually accurately capture them in separate trials, sort of what you're hearing from physicians on how those are diagnosed and bucketed. And then ultimately, whether these are differences that are meaningful in the real world and how that may impact how you're thinking about the relative opportunities of NT2 versus IH?

嘿，謝謝你回答我的問題。我只是想問您是如何看待 NT2 與 IH 人群的，以及您在不同的試驗中準確捕捉到他們的能力有何不同，還有您從醫生那裡聽到的關於如何診斷和分類這些人群的信息。最後，這些差異在現實世界中是否有意義，以及這會如何影響你對 NT2 與 IH 相對機會的看法？

I think it's an important question. I think we won't really know the answer until we complete the two studies. And I think there's differences based on our learnings in multiple discussions with clinicians and patient groups in the US and Europe, there could be regional differences too, in the way that the differential diagnosis is made. What's interesting though, Leonid, is the hypothesis there's no pretest hypothesis that suggest there might be a difference in the response between the IH/NT2 diagnosis or the sub categorization within those two diagnoses.

我認為這是一個重要的問題。我認為只有完成這兩項研究，我們才能真正知道答案。我認為，根據我們與美國和歐洲的臨床醫生和患者團體多次討論所了解到的情況，在鑑別診斷方面可能存在差異，也可能存在地區差異。不過，列昂尼德，有趣的是，目前還沒有任何預測試假設表明 IH/NT2 診斷或這兩種診斷中的亞分類之間的反應可能存在差異。

As you know, within IH, there are long sleep by age patients, they are shorter sleep IH patients. They have different phenotypes that present. What we know from our Phase 1b study, albeit small, was just taking all comers with NT2 and IH, we were able to show changes in wakefulness well-tolerated profile.

如您所知，在特發性高胰島素血症（IH）患者中，有睡眠時間較長的老年患者，也有睡眠時間較短的IH患者。它們表現出不同的表型。我們從 1b 期研究中了解到，儘管樣本量很小，但只要納入所有患有 NT2 和 IH 的患者，我們就能證明清醒狀態的變化是可以很好地耐受的。

So I think this is de novo clinical research. No one's ever tested an orexin 2 receptor agonist at these doses in these patient populations. So I think the whole community is going to be fascinating to see what the distribution looks like, what the variability looks like, and what the overall effect of various doses in these patients. And then I think with that information, we can better design Phase 3, too. Are there ways of tuning up or focusing that response in the Phase 3 studies.

所以我認為這是一項全新的臨床研究。先前從未有人在這些患者群體中測試過這些劑量的食慾素 2 受體激動劑。所以我認為整個社區都會很感興趣地觀察這些患者的分佈、變異以及各種劑量對這些患者的整體影響。我認為有了這些訊息，我們也能更好地設計第三階段。在第三階段研究中，是否有辦法調整或集中這種反應？

But our priority we're enrolling patients without any discrimination between the differential diagnosis. And interestingly, in NT2s, you tend to use MWT as an endpoint, whereas that's not used in IH to use idiopathic hypersomnia severity scale and worth. So it's -- it will be interesting to see how the two patient populations look when we're finished with the studies.

但我們的首要任務是招募患者，而不對鑑別診斷有任何歧視。有趣的是，在 NT2 中，你傾向於使用 MWT 作為終點，而 IH 中則不使用 MWT 來評估特發性嗜睡症的嚴重程度和價值。所以，研究結束後，看看這兩個患者群體的情況會很有趣。

Luke Herrmann, Baird.

盧克·赫爾曼，貝爾德。

Hey guys, congrats on the quarter and thanks for the question. Just a couple of time line questions on the earlier pipeline. So the next gen orexins are you expecting to share Phase I data from 4510 next year? And do you think there's a possibility of 7290 first in human data reading out next year as well?

嘿，各位，恭喜你們本季取得好成績，感謝你們的提問。關於之前的管道，還有幾個時間線的問題。那麼，您預計明年會分享下一代食慾素4510的I期臨床試驗數據嗎？你認為明年7290號晶片有可能率先在人體資料讀取上取得突破嗎？

And then similarly, I know it's sensitive right now before deal close. But in general, do you see a possibility of some new data on the low-salt oxybate next year?

同樣地，我知道在交易完成之前，這件事很敏感。但總的來說，您認為明年有可能獲得一些關於低鹽羥丁酸的新數據嗎？

Yeah. The 4510 and 7290, I think -- I can't say right now whether we'll show you data per se from the SAD/MAD. I think it's more of the gating, the go decision to say, if we're through state doses we think are targeting gauge and therapeutically relevant, then we're going to -- you'll know that we're moving into the patient-focused studies. The timing of the readout of those translational studies remains to be disclosed. I think we're getting a sense of it right now, but it just depends on how fast we move into those translational studies and how quick the readout is.

是的。關於 4510 和 7290，我認為——我現在還不能確定我們是否會向您展示 SAD/MAD 的具體數據。我認為更重要的是設定門檻，做出決定，如果我們已經完成了我們認為能夠達到目標指標且具有治療意義的劑量，那麼我們就會——你就會知道我們正在進入以病人為中心的研究階段。這些轉化研究結果的公佈時間仍有待公佈。我認為我們現在已經有所了解，但這取決於我們推進轉化研究的速度以及結果公佈的速度。

So give us some time to give a little bit of refinement about that as we move into 2026. But our goal is to finish SAD/MAD for 4510 first and move right into some translational studies. Same thing with 7290 get through the SAD/MAD and then go right into a different set of translational studies.

所以，請給我們一些時間，讓我們在邁向 2026 年之際，對此進行一些完善。但我們的目標是先完成 4510 的 SAD/MAD 研究，然後直接進入一些轉化研究。7290 也是一樣，經過 SAD/MAD 後，就可以直接進入另一組轉化研究。

We're obviously quite interested in the no salt once-daily development program within Avadel. And as we complete the merger, we will -- or the acquisition, what we'll do is we'll give you more sense in our hands what we'll be doing with that program. But we think it's a very logical extension to the business that LUMRYZ has built.

我們顯然對 Avadel 的無鹽每日一次的開發計劃非常感興趣。隨著合併或收購的完成，我們將讓你們更清楚地了解我們將如何推進該專案。但我們認為這是 LUMRYZ 已建立的業務的非常合乎邏輯的延伸。

Great, thank you.

太好了，謝謝。

Ami Fadia, Needham & Company.

Ami Fadia，Needham & Company。

Hi, good morning. Thanks for taking my question. With regards to impact on nighttine sleep, can you talk about the two mechanisms, orexin versus oxybate? And how you're thinking about the two mechanisms being complementary and how you intend to study that further going forward? And just separately, with regards to ARISTADA, can you talk about where you expect the gross to net to land for the full year?

您好，早安。謝謝您回答我的問題。關於對夜間睡眠的影響，您能否談談食慾素和羥丁酸這兩種機制？您如何看待這兩種機制的互補性，以及您打算如何進一步研究這一點？另外，關於 ARISTADA，您能否談談您預計全年毛利潤和淨利潤的最終結果？

Thank you.

謝謝。

Morning, it's Rich. Yeah, I think your question about nighttime sleep is going to be a very fertile one for additional clinical research. What we've heard from clinicians, you've probably heard the same thing is notwithstanding the powerful daytime wakefulness that orexin agonists are driving, there is still some interest in understanding how that coexists with consolidation of sleep at night for certain patients.

早上好，我是里奇。是的，我認為你關於夜間睡眠的問題將是一個非常值得進一步進行臨床研究的問題。我們從臨床醫生那裡聽到的（你可能也聽過同樣的說法）是，儘管食慾素激動劑能帶來強烈的白天清醒感，但人們仍然對了解這種清醒感如何與某些患者夜間睡眠鞏固共存感興趣。

Recognizing that most patients don't take oxybate, but the ones who do see real benefit from it. I think there's a real opportunity for some clinical research now to understand how the two can coexist, particularly in once nightly and once daily forms that we would control both.

有鑑於大多數患者不服用羥丁酸，但服用羥丁酸的患者確實從中受益。我認為現在確實有機會進行一些臨床研究，以了解這兩種藥物如何共存，特別是對於我們可以控制這兩種藥物的每晚一次和每天一次的形式。

So that's an exciting area for further research for patients and I think for the full field because I think that the full effect of an orexin agonist on nighttime sleep architecture is still yet to be learned. We're developing those data in our Phase II program with extensive polysomnography.

所以，這對患者來說是一個令人興奮的研究領域，我認為對於整個領域來說也是如此，因為我認為食慾素激動劑對夜間睡眠結構的全部影響還有待了解。我們正在二期臨床試驗計畫中利用大量的多導睡眠圖來收集這些數據。

So we'll be analyzing that data as we complete the virus program. But in the meantime, I think that there's a -- we see that there's a place for the oxybate on a going forward basis for the patients who really benefit from them, and we want to further elaborate that.

因此，我們將在完成病毒程式的同時分析這些數據。但同時，我認為──我們看到，對於真正能從中受益的患者來說，羥丁酸在未來仍有一席之地，我們希望進一步闡明這一點。

Todd, do you want to talk about the GTN?

托德，你想談談GTN嗎？

Yes, absolutely. For ARISTADA, for the full year, we expected to follow the consistent historical patterns, which should be approximately 53%.

是的，絕對的。對於 ARISTADA，我們預計全年將遵循一貫的歷史模式，約為 53%。

Got it. Thank you.

知道了。謝謝。

Uy Ear, Mizuho.

Uy Ear，瑞穗。

Hey guys, yeah, congrats on the quarter. So maybe just a quick question on the gross to net favorability. I think you benefit from the last quarter and this quarter for both ARISTADA and VIVITROL. Just wondering, could you maybe just help us understand whether there's more benefit going forward? Like what is being like -- yeah, help us understand why these adjustments? And secondly, in the quarter, could you also sort of speak about inventory, whether it's -- is there any stocking or is that normal level?

嘿，夥計們，是的，祝賀你們本季取得佳績。那麼，關於毛利與淨利差的問題，或許可以問一個簡單的問題。我認為ARISTADA和VIVITROL在上一季和本季都會對您有利。我想問一下，您能否幫我們了解一下，未來是否還有更多好處？例如，現在的情況是怎麼樣的？ ——是的，請幫我們理解為什麼會有這些調整？其次，關於本季的庫存狀況，您能否也談談庫存狀況，例如—是否有庫存，或庫存水準是否正常？

Yeah, absolutely. Yes, as we said in our prepared remarks, we did see a benefit for VIVITROL and ARISTADA in relation to Medicaid utilization. Going forward, we're not assuming or planning for any additional gross to net favorability within Medicaid. I think it's important just to note that the Medicaid volume, the absolute volume for Medicaid patients is stable. This is just related to the percentage of Medicaid across our overall channel mix.

是的，絕對的。是的，正如我們在準備好的演講稿中所說，我們確實看到 VIVITROL 和 ARISTADA 在 Medicaid 使用方面具有優勢。展望未來，我們不假設或計劃在醫療補助計劃中增加任何毛利與淨利差。我認為需要指出的是，醫療補助計劃的病人數量，也就是醫療補助計劃病人的絕對數量，是穩定的。這只是與我們整體通路組合中醫療補助計劃所佔的比例有關。

That was -- that's the favorability. In terms of inventory, there's always seasonal patterns during the fourth quarter, and it can be a little bit difficult to predict, but we are expecting a little bit smoother pattern from Q4 of this year into Q1 of next year.

這就是——這就是受歡迎程度。就庫存而言，第四季度總是存在季節性模式，而且很難預測，但我們預計從今年第四季到明年第一季度，庫存模式會更加平穩一些。

Okay, thanks.

好的，謝謝。

Ben Burnett, Wells Fargo.

本·伯內特，富國銀行。

Hey, good morning. I wanted to see if you could just maybe talk about some of the Phase 3 scenarios for alixorexton. I think we're assuming sort of two Phase 3s would be needed. I guess, number one, I guess, do you agree with that? And then if so, like would a Phase 3 NT2 study maybe be sufficient along with an NT1 Phase III to get approval in both of those indications?

嘿，早安。我想請您談談alixorexton的第三階段方案。我認為我們假設需要進行兩次第三階段的開發。首先，我想問的是，你同意嗎？那麼，如果是這樣，一項 NT2 的 3 期研究是否足以配合一項 NT1 的 III 期研究，從而獲得這兩種適應症的批准呢？

Hey, Ben. It's Richard. That's our assumption right now, but we'll confirm that obviously with FDA. Our expectation is that we'll seek labeling for alixorexton for the treatment of narcolepsy. And the Phase 3 program will be well-controlled Phase 2 study for NT1 on a standalone basis and a similar study in NT2.

嘿，本。是理查德。這是我們目前的假設，但我們顯然會向FDA確認。我們期望能為 alixorexton 申請用於治療嗜睡症的適應症標籤。第三階段計劃將是對 NT1 進行獨立、控制良好的第二階段研究，並對 NT2 進行類似的研究。

Douglas Tsao, HC Wainright.

Douglas Tsao，HC Wainright。

Hi, good morning. Congrats on the progress. I guess -- I know it's early, Richard and a lot of uncertainty. But just given the fact that you're always thoughtful on public policy issues, I'm just curious if you thought much about the potential impact of sort of lapse on ACA subsidies and what it could have for your commercial business in the near term? Thank you. And I have a follow-up.

您好，早安。恭喜你取得進展。我想——我知道現在還早，理查德，而且有很多不確定因素。但鑑於您一向對公共政策議題深思熟慮，我很好奇您是否認真考慮過ACA補貼失效可能帶來的影響，以及這會對您的商業活動在短期內造成什麼影響？謝謝。我還有一個後續問題。

Yeah, it's a good question, Doug. And I think everybody is watching that. I think my sense is that there's a strong political virtue to continuing the ACA subsidies at some level. And recall that a reconciliation in the One Big Beautiful Bill, what we were able to make sure is that patients in our population, i.e., patients with serious mental illness and addiction are treated differently. They are the ones who are the explicit target of programs like Medicaid because if these patients are not treated, they end up in the emergency rooms and in the criminal justice system in the community.

是的，問得好，道格。我想大家都在關注這件事。我認為，在某種程度上繼續提供《平價醫療法案》補助具有很強的政治意義。請記住，在《一個美好的大法案》中，我們透過和解確保了我們人群中的患者，即患有嚴重精神疾病和成癮症的患者，能夠得到不同的對待。他們是醫療補助等計畫的明確目標群體，因為如果這些患者無法接受治療，最終就會出現在社區的急診室和刑事司法系統中。

So the price points of our medicine stream, these patients are lower and the gross to nets are high. So they're not breaking the bank. So our view from a policy perspective is that there's a reasonable -- there's a political reason to keep ACA subsidies in place, A; and B, to the extent that we have changes that are focused on Medicaid population in particular, serious methylene and addiction patients, we're going to continue to fight to have them carved out.

因此，我們藥品價格體系中的這些患者價格較低，毛利與淨利之比較高。所以他們並沒有花光所有錢。因此，從政策角度來看，我們的觀點是，A，有合理的政治理由保留 ACA 補貼；B，如果我們的改革主要針對醫療補助人群，特別是嚴重的亞甲藍和成癮患者，我們將繼續爭取將他們排除在外。

And I guess just a follow-up on LYBALVI. I'm just curious, just given the success you had with the sort of additional promotion and detailing the product. Do you have the sense was that physicians just weren't writing and they just needed that consistent reminder? Or was there just sort of some extent, lack of awareness of the product and its attributes? Thank you.

我想就 LYBALVI 做個後續報道。我只是好奇，因為你透過這種額外的推廣和產品詳細介紹的方式取得了成功。你是否覺得醫生只是不愛寫病歷，所以需要不斷提醒他們？或者說，只是在某種程度上缺乏對產品及其特性的了解？謝謝。

Yeah. In terms of LYBALVI, I think the first thing is, over the last several years, we've had a really strong focus strategically on building awareness around the efficacy profile. And that's really resonating. It resonates every single quarter. So that's a big driver is just the underlying value of the product.

是的。就 LYBALVI 而言，我認為首先是，在過去的幾年裡，我們一直非常重視策略性地提高人們對其功效的認識。這真的引起了共鳴。每個季度都引起共鳴。所以，產品本身的內在價值就是一個重要的驅動因素。

It's also important to remember that LYBALVI is a broad label, right? So we have a broad addressable population. So we're seeing strong growth with schizophrenia and bipolar. The mix is still roughly about 50-50, but new patient starts are definitely growing more towards the bipolar population.

還有一點要記住的是，LYBALVI 是一個涵蓋範圍很廣的標籤，對吧？因此，我們擁有廣泛的目標受眾。因此，我們看到精神分裂症和雙相情感障礙的病例數量大幅增加。雖然男女比例仍大致為 50:50，但新入院患者的雙極性情感障礙患者比例明顯越來越高。

And so I think with the strong efficacy along with our commercial execution and then also resourcing that we've put behind the brand, we actually really saw a very positive quarter, and our expectation is that -- and our focus is really growing that demand going into the fourth quarter as well.

因此，我認為憑藉強大的功效、有效的商業執行以及我們為該品牌投入的資源，我們實際上看到了一個非常積極的季度，我們預計——我們的重點是真正地在第四季度擴大需求。

I guess just sort of what was driving it? Do you think that some clinicians are more familiar that you had the breadth of label for bipolar and the efficacy? Or was it just those are competitive markets and you just constantly need to stay in front of reps? Thank you.

我猜想，究竟是什麼原因導致了這種情況？你認為有些臨床醫師是否更熟悉雙極性情感障礙的診斷範圍和療效？還是只是因為這些市場競爭激烈，所​​以你需要不斷超越銷售代表？謝謝。

Yeah, it's a good point. The competitive landscape is fierce, as we know. And so we're very practical with this to make sure that we're putting resources in our highest growth driver. So we felt and the data showed us that we needed a stronger share of voice. But number two is physician research tells us that HCPs need experience.

沒錯，你說得有道理。我們都知道，競爭環境非常激烈。因此，我們在這方面非常務實，確保將資源投入成長最快的領域。因此我們感到，數據也表明，我們需要更大的話語權。但第二點是，醫生研究告訴我們，醫療保健專業人員需要經驗。

So once they get experience with one patient type, schizophrenia or bipolar, in general, patients are having a good experience, they're more open to expanding their breadth of prescribing. And so we're very pleased, as I said earlier, breadth of prescribing has expanded by approximately 7% for two consecutive quarters, and we're seeing encouraging trends with debt. So it's really those two things. It's our commercial investment, but it's also the experience of the HCP and the positive experience they're hearing from patients.

因此，一旦他們累積了治療某一類患者（例如精神分裂症或雙相情感障礙）的經驗，並且患者總體上獲得了良好的體驗，他們就更願意擴大處方範圍。因此我們非常高興，正如我之前所說，處方範圍連續兩個季度擴大了約 7%，而且我們在債務方面也看到了令人鼓舞的趨勢。所以，關鍵就在於這兩件事。這既是我們的商業投資，也是醫療保健專業人員的經驗以及他們從患者那裡聽到的積極回饋。

Okay, great. Thank you.

好的，太好了。謝謝。

Jason Gerberry, Bank of America.

傑森‧格伯里，美國銀行。

Hey, this is Chi on for Jason. I want to follow up on the virtual AE commentary earlier for Vibrance-1. The commentary that I heard was that most visual AEs were mild, and there was one moderate and one severe case. Can you contextualize one constitute a severe vision blur and how long did AE last?

嘿，我是Chi，為您報道Jason。我想就之前 Vibrance-1 的虛擬 AE 評論做個後續說明。我聽到的評論是，大多數視覺不良事件都是輕微的，只有一例中度不良事件和一例重度不良事件。你能具體說明一下「嚴重視力模糊」的定義，以及這種不良事件持續了多久嗎？

And secondarily, is there a dose response relationship with the virtual AE and Vibrance-1? When I look back at the Vibrance-1 AE table, there was this severe case of any cause in the 4-milligram dose and two severe cases of any cost in 8-milligram dose. Can you clarify which dose level is that one moderate case of visual AE and which dose level did the one severe virtual AE case occurred in?

其次，虛擬 AE 與 Vibrance-1 之間是否存在劑量反應關係？當我回顧 Vibrance-1 AE 表格時，發現 4 毫克劑量組出現 1 例任何原因引起的嚴重不良事件，8 毫克劑量組出現 2 例任何原因引起的嚴重不良事件。能否說明一下，那例中度視覺不良事件發生在哪個劑量水平，那例重度虛擬不良事件發生在哪個劑量水平？

Thanks so much.

非常感謝。

Yeah, the vast preponderance of the visual AE, they were actually reported as blurred vision were mild cases. There was one moderate that became a mild after four days, I believe. And there was once that was categorized as severe, but that was part of a constellation of symptoms that led to an early termination of that patient after the third day, I believe, in the study.

是的，絕大多數視覺異常事件，實際上都被報告為視力模糊，而且都是輕症病例。我記得有一例中度感染，四天後變成了輕度感染。曾經有一例被歸類為重症的病例，但那隻是導致該患者在研究的第三天後提前終止治療的一系列症狀之一。

So there was dose response. We saw more at the 8-milligram dose than the 4 and the 6. But interestingly, in the extension period after patients have been in the double-blind period and could choose their dose. If patients had been on a previous dose of alixorexton then move to the 8 milligram, we saw no new incidence of visual AEs of burn vision. So we think that there is dose response. We think the phenomena is largely mild, meaning it's noted by the patient but doesn't affect them.

所以存在劑量反應關係。我們發現 8 毫克劑量組的效果比 4 毫克和 6 毫克劑量組更好。但有趣的是，在患者完成雙盲期後，在延長期內，他們可以選擇自己的劑量。如果患者之前服用過 alixorexton，然後改為服用 8 毫克，我們沒有看到新的燒傷視力不良反應發生。所以我們認為有劑量反應關係。我們認為這種現像大致上比較輕微，也就是說患者會注意到，但不會對其造成影響。

And largely occurred in the first week and are largely transient as well. But we'll see now in the NT2 data set, what that looks like in the IHs as well. But as we build a bigger and bigger data set, the overall conclusion, I think you have to draw from this class so far as they're largely generally well tolerated, and the side effects are generally mild to moderate and transient. And the top of the list of the AEs that are on target, you're going to see what these drugs are insomnia and pollakiuria which is urinary frequency.

而且大多發生在第一周，也大多是短暫的。但我們現在將在 NT2 資料集中看到，這在 IH 中也是什麼樣子。但隨著我們建立越來越大的數據集，我認為到目前為止，你必須從這個班級得出的總體結論是，它們總體上耐受性良好，副作用通常是輕微到中度的，而且是短暫的。在目標不良反應清單中，你會看到這些藥物最主要的副作用是失眠和頻尿。

Okay. Thanks.

好的。謝謝。

Thank you. That will conclude our question-and-answer session. I'll turn the floor back to management for closing comments.

謝謝。我們的問答環節到此結束。我將把發言權交還給管理階層，請他們做總結陳詞。

All right. Thanks, everyone, for joining us on the call today. Please don't hesitate to reach out to the company if there are any follow-up questions.

好的。感謝各位今天參加我們的電話會議。如有任何後續問題，請隨時與本公司聯絡。

Thank you. This will conclude today's conference. You may disconnect your lines at this time, and have a wonderful day.

謝謝。今天的會議到此結束。現在您可以斷開線路了，祝您有美好的一天。