Alkermes Plc (ALKS) 2024 Q2 法說會逐字稿

Greetings and welcome to the Alkermes' second quarter 2024 financial results conference call. My name is Rob and I'll be your operator for today's call. All participant lines will be placed on mute to prevent background noise. (Operator Instructions) Please note this conference is being recorded.

歡迎參加 Alkermes 2024 年第二季財務業績電話會議。我叫羅布，我將擔任您今天通話的接線生。所有參與者線路將置於靜音狀態，以防止背景噪音。（操作員說明）請注意，本次會議正在錄製中。

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

我現在將把電話轉給投資者關係和公司事務高級副總裁桑德拉·庫姆斯(Sandra Coombs)。桑迪，你現在可以開始了。

Thank you. Welcome to the Alkermes Plc conference call to discuss our financial results and business update for the quarter ended June 30, 2024. With me today are Richard Pops, our CEO; Todd Nichols, our Chief Commercial Officer and Blair Jackson, our Chief Operating Officer.

謝謝。歡迎參加 Alkermes Plc 電話會議，討論我們截至 2024 年 6 月 30 日的季度的財務業績和業務更新。今天和我在一起的有我們的執行長理查德·波普斯 (Richard Pops)；托德·尼科爾斯（Todd Nichols），我們的首席商務官；布萊爾·傑克遜（Blair Jackson），我們的首席營運長。

During today's call, we will be referencing slides. These slides, 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 Investors section of alkermes.com.

在今天的電話會議中，我們將參考投影片。這些投影片以及我們今天將討論的與新聞稿相關的財務表格以及 GAAP 與非 GAAP 財務指標的調整表均可在 alkermes.com 的投資者部分取得。

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. 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.

我們相信，非公認會計準則財務績效與公認會計準則績效相結合，有助於了解我們業務的持續經濟狀況。我們在本次電話會議期間的討論將包括前瞻性陳述。實際結果可能與這些前瞻性陳述有重大差異。請參閱隨附簡報的幻燈片2、我們今天上午發布的新聞稿以及我們向SEC 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陳述中明示或暗示的結果有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或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提供的資訊的義務。在我們準備好發言後，我們將開始問答環節。

And now I'll turn the call over to Blair for a review of the quarterly financial results.

現在我將把電話轉給布萊爾，要求他審查季度財務表現。

Thank you, Sandy. Our second quarter results reflect robust profitability and solid execution across our business, delivering double-digit year-over-year growth for our proprietary commercial product portfolio. The year is proceeding as planned and we enter the second half in a strong position with clear priorities to deliver on our 2024 financial expectations, which we are reiterating today.

謝謝你，桑迪。我們第二季的業績反映了我們整個業務強勁的獲利能力和紮實的執行力，為我們專有的商業產品組合帶來了兩位數的同比增長。今年正在按計劃進行，我們在進入下半年時處於有利地位，並有明確的優先事項來實現我們今天重申的 2024 年財務預期。

For the second quarter, we generated total revenues of $399.1 million, driven by our proprietary product portfolio, which grew 16% year-over-year. Starting with VIVITROL, net sales in the quarter were $111.9 million, compared to $102.1 million in the same period last year.

在我們專有產品組合的推動下，第二季我們的總營收達到 3.991 億美元，年增 16%。從 VIVITROL 開始，該季度的淨銷售額為 1.119 億美元，而去年同期為 1.021 億美元。

For the ARISTADA product family, net sales were $86 million compared to $82.4 million for the same period last year. For LYBALVI, net sales were $71.4 million, compared to $47 million for the same period in the prior year, which represented 52% year-over-year growth driven by robust underlying demand.

ARISADA 產品系列的淨銷售額為 8,600 萬美元，而去年同期為 8,240 萬美元。LYBALVI 的淨銷售額為 7,140 萬美元，而去年同期為 4,700 萬美元，在強勁的潛在需求的推動下，同比增長 52%。

Across our proprietary commercial products, inventory in the channel returned to normal levels on a months on hand basis during the second quarter following the drawdown we experienced in the first quarter of this year.

在我們的專有商業產品中，繼今年第一季經歷了庫存下降之後，第二季通路庫存按月計算恢復到正常水平。

Moving on to our manufacturing and royalty business, in the second quarter of 2024, we recorded manufacturing and royalty revenues of $129.9 million. Revenues from the long-acting INVEGA products were $78.7 million compared to $321.2 million for Q2 last year, which included $245.5 million of back royalties and related interest following the successful resolution of our arbitration with Janssen.

繼續我們的製造和特許權使用費業務，2024 年第二季度，我們的製造和特許權使用費收入為 1.299 億美元。長效 INVEGA 產品的收入為 7,870 萬美元，而去年第二季為 3.212 億美元，其中包括我們與楊森成功解決仲裁後的 2.455 億美元返還特許權使用費和相關利息。

As previously disclosed and reflected in our financial expectations for the year, our royalties and net sales of INVEGA SUSTENNA in the US will end in mid-August of this year. We expect the impact on our third quarter results will be approximately $20 million. We will continue to receive royalties on net sales of INVEGA TRINZA and INVEGA HAFYERA in the US and on the long-acting INVEGA products outside the US. Revenues from VUMERITY were $35.2 million, compared to $32.3 million for Q2 last year.

正如先前披露的並反映在我們今年的財務預期中，我們在美國的 INVEGA SUSTENNA 的特許權使用費和淨銷售額將於今年 8 月中旬結束。我們預計對第三季業績的影響約為 2,000 萬美元。我們將繼續收取 INVEGA TRINZA 和 INVEGA HAFYERA 在美國的淨銷售額以及美國以外的長效 INVEGA 產品的特許權使用費。VUMERITY 的營收為 3,520 萬美元，而去年第二季為 3,230 萬美元。

Now I'll turn to our operating expenses and our financial results from continuing operations following the separation of our oncology business late last year. Cost of goods sold were $61.5 million, compared to $63.2 million for Q2 last year.

現在我將談談去年年底腫瘤業務分拆後我們的營運費用和持續營運的財務表現。銷售成本為 6,150 萬美元，而去年第二季為 6,320 萬美元。

R&D expenses were $59.6 million, compared to $68.2 million for Q2 last year. This reflects focused investments in our neuroscience development programs, primarily related to the ALKS 2680 clinical program and support activities for our proprietary commercial products. We expect R&D expense to remain relatively steady at this level through the end of the year.

研發費用為 5,960 萬美元，去年第二季為 6,820 萬美元。這反映了我們對神經科學開發項目的重點投資，主要與 ALKS 2680 臨床項目和我們專有商業產品的支援活動有關。我們預計研發費用到年底將維持相對穩定在這個水準。

SG&A expenses were $168.1 million compared to $195.8 million for Q2 last year. The decrease was primarily driven by operational efficiencies and a number of non-recurring expenses that were recorded in the second quarter of 2023. Looking ahead, we continue to expect SG&A expenses to decrease in the second-half of 2024, primarily reflecting the timing and mix of commercial promotional activities.

SG&A 費用為 1.681 億美元，去年第二季為 1.958 億美元。這一下降主要是由於營運效率和 2023 年第二季記錄的一些非經常性費用造成的。展望未來，我們繼續預期 2024 年下半年的銷售、管理及行政費用將減少，這主要反映了商業促銷活動的時間表和組合。

We continue to focus on driving profitability and during the second quarter, we delivered GAAP net income from continuing operations of $94.7 million, non-GAAP net income from continuing operations of $123.4 million, and EBITDA from continuing operations of $118.6 million.

我們繼續專注於提高獲利能力，在第二季度，我們實現了來自持續營運業務的GAAP 淨利潤9,470 萬美元，來自持續營運業務的非GAAP 淨利潤為1.234 億美元，來自持續營運業務的EBITDA 為1.186億美元。

Turning to our balance sheet, we ended the second quarter in a strong financial position with $962.5 million in cash and total investments. In May, we completed the sale of our Athlone, Ireland manufacturing facility to Novo Nordisk and received a cash payment of approximately $91 million for the facility and related assets. This transaction represents a key element of our multi-year strategy to drive operational efficiency and further align our infrastructure and cost framework with the anticipated needs of the business.

談到我們的資產負債表，我們第二季末的財務狀況強勁，現金和總投資為 9.625 億美元。5 月，我們完成了將愛爾蘭阿斯隆製造工廠出售給諾和諾德 (Novo Nordisk) 的交易，並收到了約 9,100 萬美元的現金用於購買該工廠及相關資產。這項交易是我們多年策略的關鍵要素，旨在提高營運效率，並進一步使我們的基礎設施和成本框架與業務的預期需求保持一致。

Additionally, as part of the $400 million share repurchase program authorized earlier this year, the company repurchased approximately 3.5 million of our outstanding shares during the quarter for an aggregate purchase price of $84.7 million, and we have since continued to be actively repurchasing shares opportunistically in the market.

此外，作為今年稍早授權的4 億美元股票回購計畫的一部分，該公司在本季回購了約350 萬股已發行股票，總購買價為8,470 萬美元，此後我們繼續積極趁機回購股票。

Taking a step back, we are pleased with the progress we have made as we've continued to deliver on our multi-year plan to streamline the business and strengthen our financial operating profile while advancing ALKS 2680 rapidly in the clinic. As we look at the second-half of the year, we're in a strong financial position as we work to execute on our strategic priorities, drive momentum across our business and deliver robust profitability.

退後一步來說，我們對所取得的進展感到高興，因為我們繼續實施我們的多年計劃，以簡化業務並加強我們的財務運營狀況，同時在診所快速推進 ALKS 2680。展望今年下半年，我們的財務狀況強勁，我們致力於執行我們的戰略重點，推動整個業務的發展勢頭並實現強勁的盈利能力。

With that, I'll now hand the call to Todd.

現在，我將把電話轉給托德。

Thank you, Blair and good morning everyone. We generated strong growth for our proprietary product portfolio in the second quarter. This was an important priority for our annual plan, and we delivered on that objective. During the quarter, our team drove net sales of our proprietary product portfolio of $269.3 million, reflecting 16% year-over-year growth. With two remaining quarters in the year, we are on track to achieve our previously announced financial expectations of our proprietary net sales in excess of $1 billion in 2024.

謝謝布萊爾，大家早安。我們的專有產品組合在第二季度實現了強勁成長。這是我們年度計劃的一個重要優先事項，我們實現了這一目標。本季度，我們的團隊推動專有產品組合的淨銷售額達到 2.693 億美元，年增 16%。在今年剩下的兩個季度裡，我們預計將實現先前宣布的 2024 年自營淨銷售額超過 10 億美元的財務預期。

I'll focus on LYBALVI, followed by quick updates on VIVITROL and ARISTADA. During the second quarter, we generated LYBALVI net sales of $71.4 million. Total prescriptions of LYBALVI grew 12% sequentially and 44% year-over-year to approximately 55,300 during the quarter, reflecting strong underlying demand and continued expansion of prescriber breadth and depth.

我將重點介紹 LYBALVI，然後快速更新 VIVITROL 和 ARISADA。第二季度，我們的 LYBALVI 淨銷售額為 7,140 萬美元。本季 LYBALVI 的處方總數較上季成長 12%，年成長 44%，達到約 55,300 個，反映出強勁的潛在需求以及處方者廣度和深度的持續擴展。

Optimizing LYBALVI's access profile continues to be an important element of our long-term growth strategy for the brand, and compared to the beginning of the year, approximately 50 million additional lives now have improved access to LYBALVI. These enhancements are the result of our disciplined contracting strategy.

優化 LYBALVI 的訪問概況仍然是我們品牌長期成長策略的重要組成部分，與年初相比，現在大約有 5000 萬人增加了對 LYBALVI 的訪問。這些增強是我們嚴格的承包策略的結果。

During the quarter, we entered into a second major commercial contract as well as a contract that further improved formulary positioning on an important Medicare Part D plan, both of which took effect on July 1. Similar to the commercial contract we announced last quarter, these contracts are not expected to significantly impact our anticipated gross to net adjustments. Looking ahead for the full-year, we continue to expect LYBALVI net sales in the range of $275 million to $295 million.

在本季度，我們簽訂了第二份主要商業合同以及一份進一步改善重要醫療保險 D 部分計劃的處方定位的合同，這兩項合同均於 7 月 1 日生效。與我們上季宣布的商業合約類似，這些合約預計不會對我們預期的毛淨調整產生重大影響。展望全年，我們繼續預期 LYBALVI 淨銷售額在 2.75 億美元至 2.95 億美元之間。

Turning to the ARISTADA product family, net sales in the second quarter were $86 million. While the long-acting antipsychotic market experienced some softness, ARISTADA new to brand prescriptions demonstrated encouraging growth. For the full-year, we continue to expect ARISTADA net sales in the range of $340 million to $360 million as we focus on commercial execution and continue to differentiate ARISTADA in the long-acting antipsychotics space.

至於 ARISADA 產品系列，第二季的淨銷售額為 8,600 萬美元。雖然長效抗精神病藥物市場經歷了一些疲軟，但新品牌處方 ARISADA 卻表現出令人鼓舞的成長。對於全年，我們繼續預計 ARISADA 的淨銷售額在 3.4 億至 3.6 億美元之間，因為我們專注於商業執行並繼續使 ARISADA 在長效抗精神病藥物領域脫穎而出。

Moving to VIVITROL, net sales in the second quarter were at $111.9 million, representing 10% year-over-year growth driven by underlying demand. VIVITROL performance continued to be largely driven by the opportunity of alcohol dependence indication, which currently accounts for more than 75% of VIVITROL volume.

至於 VIVITROL，第二季淨銷售額為 1.119 億美元，在潛在需求的推動下年增 10%。VIVITROL 的表現持續在很大程度上受到酒精依賴適應症機會的推動，目前佔 VIVITROL 銷售量的 75% 以上。

For the full-year, we continue to expect VIVITROL net sales in the range of $410 million to $430 million. With a solid Q2 now behind us, looking ahead, we expect to see typical summer demand patterns across our proprietary commercial product portfolio. Against that backdrop, our team will maintain its sharp focus on strong execution, highlighting the differentiating features of our medicines and driving uptake of our products. We look forward to sharing our progress with you.

對於全年，我們繼續預期 VIVITROL 淨銷售額在 4.1 億美元至 4.3 億美元之間。隨著第二季的強勁表現，展望未來，我們預期我們專有的商業產品組合將出現典型的夏季需求模式。在此背景下，我們的團隊將繼續高度重視強有力的執行力，突顯我們藥品的差異化特徵並推動我們產品的使用。我們期待與您分享我們的進展。

With that, I will pass the call to Richard.

這樣，我就把電話轉給理查。

That's great. Thank you, Todd. Good morning, everyone. So we're now mid-way through the year and making excellent progress across the objectives we set for 2024. Those objectives are driving commercial and financial performance, advancing ALKS 2680 in our neuroscience development pipeline, completing the sale of our Athlone manufacturing facility, and using our strengthened balance sheet to return capital to shareholders as opportunities present themselves.

那太棒了。謝謝你，托德。大家，早安。因此，我們現在已進入今年中期，並且在我們為 2024 年設定的目標方面取得了巨大進展。這些目標正在推動商業和財務業績，在我們的神經科學開發管道中推進 ALKS 2680，完成我們的 Athlone 製造工廠的出售，並利用我們強化的資產負債表在機會出現時將資本返還給股東。

Alkermes is now a biopharmaceutical growth company with multiple proprietary commercial products, an efficient operating structure and a development pipeline with significant potential value. This is the result of a multi-year evolution from a legacy business as a partner to larger pharmaceutical companies to an integrated, pure-play neuroscience company with a financial profile driven by the performance of a proprietary commercial portfolio. Our proven ability to bring new neuroscience medicines with significant medical and economic value to market is the foundation for new growth opportunities.

Alkermes 現在是一家生物製藥成長型公司，擁有多種專有商業產品、高效的營運結構和具有巨大潛在價值的開發管道。這是多年演變的結果，從作為大型製藥公司合作夥伴的傳統業務發展成為一家綜合性、純粹的神經科學公司，其財務狀況由專有商業投資組合的業績驅動。我們將具有重大醫療和經濟價值的新神經科學藥物推向市場的能力已得到證實，這是新成長機會的基礎。

This is an important transition and we're well positioned to execute our plan to become a leader among neuroscience companies. ALKS 2680 is becoming an important element of our growth strategy. ALKS 2680 is our novel, investigational, once daily oral orexin-2 receptor agonist for narcolepsy, currently in Phase 2 development.

這是一個重要的轉變，我們有能力執行我們的計劃，成為神經科學公司的領導者。ALKS 2680 正在成為我們成長策略的重要組成部分。ALKS 2680 是我們用於治療發作性睡病的新型研究性每日一次口服 orexin-2 受體激動劑，目前處於第 2 期開發階段。

During the quarter, we provided key data updates and met significant operational milestones in our expanding clinical program. As we enter Q3, ALKS 2680 is the only orexin agonist proceeding into Phase 2 in both narcolepsy Type 1 and Type 2, supported by positive early clinical data in both indications.

在本季度，我們提供了關鍵數據更新，並在不斷擴大的臨床計劃中實現了重要的營運里程碑。當我們進入第三季時，ALKS 2680 是唯一進入 1 型和 2 型發作性睡病第 2 期的食慾素激動劑，這兩種適應症都有積極的早期臨床數據支持。

So let's start with our work in narcolepsy Type 1 or NT1. During the quarter, we initiated our Phase 2 study, Vibrance-1, which is a randomized, placebo-controlled, multinational study evaluating the safety, tolerability and efficacy of three different doses of ALKS 2680. We are initiating sites and beginning to enroll patients in the study.

讓我們從 1 型發作性睡病或 NT1 型發作性睡病的研究開始。本季度，我們啟動了 2 期研究 Vibrance-1，這是一項隨機、安慰劑對照、跨國研究，評估三種不同劑量 ALKS 2680 的安全性、耐受性和有效性。我們正在啟動研究地點並開始招募患者參加研究。

The Vibrance-1 Phase 2 study was informed by data from our phase 1b proof of concept study. Last month at the 2024 SLEEP Meeting in Houston, we presented data from the full NT1 cohort from the phase 1b study. This medical congress gave us the opportunity to share the data set with thought leaders and physicians within the broader clinical community, along with patient advocacy organizations that play a key role in this therapeutic space.

Vibrance-1 第 2 階段研究是根據我們第 1b 階段概念驗證研究的資料得出的。上個月在休士頓舉行的 2024 年 SLEEP 會議上，我們展示了 1b 期研究的完整 NT1 隊列的數據。這次醫學大將使我們有機會與更廣泛的臨床社區內的思想領袖和醫生以及在該治療領域發揮關鍵作用的患者倡導組織共享數據集。

Feedback from these stakeholders bolstered our belief that the orexin-2 receptor agonist mechanism represents an opportunity to transform the treatment of narcolepsy. In early April, we also announced positive top line data from the 1b cohorts with narcolepsy Type 2 or NT2 and idiopathic hypersomnia. We plan to present additional data from the phase 1b study at the upcoming SLEEP Europe meeting in September.

這些利害關係人的回饋增強了我們的信念，即食慾素 2 受體激動劑機制代表了改變發作性睡病治療的機會。4 月初，我們也發表了 2 型發作性睡病或 NT2 型嗜睡症和特發性嗜睡症 1b 隊列的陽性頂線數據。我們計劃在 9 月即將召開的 SLEEP Europe 會議上展示更多 1b 期研究的數據。

The data from the 1b in NT2 support advancement into a planned Phase 2 study, which will be called Vibrance-2. Vibrance-2 will leverage much of the work we've been doing launching Vibrance-1, so we're moving quickly and expect to initiate that study and open it for patient enrollment toward the end of the summer.

NT2 1b 的數據支持進入計劃中的第 2 階段研究，該研究將被稱為 Vibrance-2。Vibrance-2 將利用我們在啟動 Vibrance-1 時所做的大部分工作，因此我們正在迅速行動，預計啟動這項研究，並在夏末開放供患者入組。

NT2 represents a significant potential opportunity for ALKS 2680 and advancing in the clinic in this patient population is becoming an important differentiating feature for ALKS 2680. A key element across the Phase 2 program is the range of doses that will be evaluated, 4, 6, and 8 milligrams in NT1 and 10, 14, and 18 milligrams in NT2.

NT2 代表了 ALKS 2680 的一個重要潛在機會，在該患者群體中的臨床進展正在成為 ALKS 2680 的一個重要差異化特徵。第二階段計畫的關鍵要素是評估的劑量範圍，NT1 為 4、6 和 8 毫克，NT2 為 10、14 和 18 毫克。

Exploring this continuous dose range will allow us to comprehensively establish the dose response curve and the safety and tolerability profile of ALKS 2680 in narcolepsy Type 1 and Type 2. This range of doses also presents the potential to accommodate a spectrum of patient profiles and treatment objectives.

探索這個連續劑量範圍將使我們能夠全面建立 ALKS 2680 在 1 型和 2 型發作性睡病中的劑量反應曲線以及安全性和耐受性概況。此劑量範圍還具有適應一系列患者概況和治療目標的潛力。

Beyond narcolepsy, data from across our phase 1 study of ALKS 2680 support our hypothesis that orexin-2 receptor agonist such as ALKS 2680 may have utility in treating a range of neurological disorders where excessive daytime sleepiness is a serious clinical consideration. The positive results in idiopathic hypersomnia or IH in the phase 1b study begin to build supporting evidence for this hypothesis. IH by itself represents a meaningful potential opportunity and we are evaluating our strategic development plan in that underserved disease area.

除了發作性睡病之外，我們對ALKS 2680 進行1 期研究的數據支持了我們的假設，即ALKS 2680 等食慾素2 受體激動劑可能可用於治療一系列神經系統疾病，其中白天過度嗜睡是一個嚴重的臨床考慮因素。1b 期研究中特發性嗜睡症或 IH 的正面結果開始為此假設提供支持證據。IH 本身代表了一個有意義的潛在機會，我們正在評估我們在該服務不足的疾病領域的策略發展計劃。

And more broadly, the IH data further suggests that ALKS 2680 can drive meaningful changes in wakefulness in patients with relatively normal orexin levels and provide additional support for the evaluation of broader clinical uses for these agents.

更廣泛地說，IH 數據進一步表明 ALKS 2680 可以推動食慾素水平相對正常的患者的覺醒發生有意義的變化，並為評估這些藥物更廣泛的臨床用途提供額外支持。

The work to explore these broader opportunities and advance our portfolio of preclinical Orexin-2 receptor agonists is well underway. We have been active with our preclinical experimentation and new IP filings are in process. We plan to share more about our development strategy later this year.

探索這些更廣泛的機會並推進我們的臨床前 Orexin-2 受體激動劑產品組合的工作正在順利進行中。我們一直在積極進行臨床前實驗，新的智慧財產權申請正在進行中。我們計劃在今年稍後分享更多有關我們的發展策略的資訊。

I'm going to end with a brief update on our capital allocation strategy. The business is in a strong position to generate considerable excess cash flow while investing in the growth of our commercial portfolio and advancing our pipeline as evident in our results year-to-date.

最後，我將簡要介紹我們的資本配置策略。該業務處於有利地位，可以產生大量超額現金流，同時投資於我們商業投資組合的成長並推進我們的管道，這一點從我們今年迄今的業績中可以看出。

Based on the progress we're making in the business measured against the current valuation, we see a substantial opportunity to capture value for shareholders. In Q2, we activated our share repurchase program. We will continue to be active in the market, informed by the ongoing needs of the business and evolving market conditions.

根據我們在業務中取得的進展（以當前估值衡量），我們看到了為股東獲取價值的巨大機會。第二季度，我們啟動了股票回購計畫。我們將根據業務的持續需求和不斷變化的市場狀況，繼續活躍在市場上。

Across the business, we generated a strong financial and operational performance in the first-half of the year. Looking ahead, we have clear goals and priorities to advance the business and we'll maintain a sharp focus on execution and efficiency to deliver on those objectives. So we look forward to sharing our progress with you.

在整個業務領域，我們在今年上半年取得了強勁的財務和營運表現。展望未來，我們有明確的目標和優先事項來推動業務發展，我們將繼續高度關注執行力和效率，以實現這些目標。因此，我們期待與您分享我們的進展。

And I'll turn it back to Sandy to run the Q&A.

我會將其轉回給桑迪進行問答。

Great thanks. Rob, we'll now open the call for Q&A, please.

萬分感謝。羅布，我們現在將開始問答環節。

Thank you, Sandy. (Operator Instructions)

謝謝你，桑迪。（操作員說明）

Hold on one second. Okay, Rob, go ahead.

等一下。好吧，羅布，繼續吧。

Thank you. Umer Raffat, Evercore ISI.

謝謝。烏默·拉法特，Evercore ISI。

Thanks for taking my question. Maybe a couple today, if I may, not on orexin specifically actually. I was curious as we think about sort of the value of the base business and the trajectory of your underlying EPS of the business, which is now profitable. Richard, how are you thinking about the M&A priorities and the types of things and assets you're considering? Are they more on the pipeline side? Or are they more on something that could add to the EPS or profitability in short order, if not right away? Because I think they'll be very relevant for us to think about in terms of the direction EPS is headed.

感謝您提出我的問題。如果可以的話，今天也許有幾個，其實不是專門針對食慾素。當我們思考基礎業務的價值以及該業務的基本每股盈餘的軌跡時，我很好奇，該業務現在已經獲利。理查德，您如何看待併購的優先事項以及您正在考慮的事物和資產的類型？他們更多的是在管道方面嗎？或者他們是否更看重能夠在短期內（如果不是立即）增加每股收益或獲利能力的東西？因為我認為它們對於我們思考每股盈餘的發展方向非常重要。

And then secondly, by my math, it looks like there may be about $4 million worth of inventory build into -- or inventory recovery on liability this quarter. Could you please clarify that as well? Thank you.

其次，根據我的計算，本季可能有價值約 400 萬美元的庫存建立或庫存回收。能否也澄清一下？謝謝。

Sure. I'll take the first one over, and then I'll let Blair and Todd weigh in on the inventory side. Yeah, I think that our M&A priorities are consistent quarter to quarter, and we're actually really interested in both of those domains. EPS augmentation through commercial products that would drop profits to the bottom line, as well as expanding the pipeline.

當然。我將接管第一個任務，然後讓布萊爾和托德在庫存方面進行權衡。是的，我認為我們的併購優先事項每季都是一致的，而且我們實際上對這兩個領域都非常感興趣。透過商業產品增加每股收益，這將使利潤降至底線，並擴大管道。

So if we fast forward in a couple of years to look at this company, what should it look like? It should have a robust, growing top line, strong profitability, and an expanded pipeline. So we need to build across each of those axes. Blair?

那麼，如果我們快轉幾年後看看這家公司，它應該是什麼樣子？它應該擁有強勁且不斷增長的營收、強勁的獲利能力和不斷擴大的產品線。因此，我們需要在每個軸上進行建造。布萊爾？

Yeah. And then I think with regards to inventory, your math is great. So we did see it. Remember, a shortness of inventory in Q1. We've recovered in LYBALVI in Q2 and the same goes for all of our other programs as well.

是的。然後我認為關於庫存，你的數學很棒。所以我們確實看到了。請記住，第一季庫存短缺。我們在第二季的 LYBALVI 已經恢復，我們所有其他項目也是如此。

Charles Duncan, Cantor Fitzgerald.

查爾斯鄧肯，坎托菲茨杰拉德。

Hey. Good morning. Thanks for taking the question, and congrats on a good quarter. I had two questions, one on pipeline, one on commercial. The first is on the pipeline. With regard to Vibrance-1, you said that you've begun enrolling patients, and I guess I'm wondering, with that cadence, can you give us a sense of timing to data with Vibrance-1?

嘿。早安.感謝您提出問題，並祝賀您度過了一個美好的季度。我有兩個問題，一是關於管道，一是關於商業。第一個是在管道上。關於 Vibrance-1，您說您已經開始招募患者，我想我想知道，以這種節奏，您能否讓我們了解 Vibrance-1 數據的時間安排？

And then with regard to the commercial question on LYBALVI, give us a little bit of color on in-market kind of dynamics. And what would you expect with a possible coming approval for KarXT and how that could be impacted? Thanks.

然後關於 LYBALVI 的商業問題，請給我們一些關於市場動態的資訊。您對 KarXT 可能即將獲得批准有何期望？謝謝。

Good morning, Charles. It's Rich. I'll start. Yeah, Vibrance-1, I think the primary operational, you know, managerial focus right now is site activation. So we will be activating sites all through the summer into the fall. It's a fairly large national -- multinational study.

早上好，查爾斯。這是富有的。我開始吧。是的，Vibrance-1，我認為現在主要的營運、管理重點是站點啟動。因此，我們將在整個夏季到秋季激活站點。這是一項規模相當大的全國性、跨國研究。

So it's too early now. We're just in the beginning of the enrollment curve. So it's too early to extrapolate, but we will for sure give you guys better visibility into that as we get it ourselves, as sites get activated. And I'll let Todd and Blair comment on the end-market dynamics in LYBALVI right now.

所以現在還為時過早。我們正處於入學曲線的開始階段。所以現在推斷還為時過早，但當我們自己得到它並激活網站時，我們肯定會讓你們更好地了解這一點。我現在將讓托德和布萊爾評論 LYBALVI 的終端市場動態。

Yeah, absolutely. So in general, the way we're thinking about LYBALVI and what we saw all in Q2 is we saw strong underlying demand overall that led to about 12% increase in TRx growth, which is really encouraging and what we expected, and that was really driven by new patient starts. New patient starts, which is defined as NBRx grew about 17% quarter-over-quarter. So really solid growth on new patient starts, which was driven by breadth of prescribing.

是的，絕對是。因此，總的來說，我們對LYBALVI 的看法以及我們在第二季度看到的情況是，我們看到整體強勁的潛在需求，導致TRx 增長約12％，這確實令人鼓舞，也是我們所期望的，這確實是由新患者開始驅動。新患者開始數（定義為 NBRx）較上季成長約 17%。因此，新患者的開始確實實現了穩健的成長，這是由處方的廣度所推動的。

So we continue to see breadth of prescribing expand year-over-year. Breadth of prescribing expanded about 23% and our expectation is that will continue that's supported by a lot of our market research. When we talk to HCPs in our target audience, greater than 90% of them tell us that they plan to continue to expand prescribing. So we think it's a really encouraging trend.

因此，我們繼續看到處方的範圍逐年擴大。處方範圍擴大了約 23%，我們的大量市場研究支持這種情況將持續下去。當我們與目標受眾中的 HCP 交談時，超過 90% 的人告訴我們他們計劃繼續擴大處方範圍。所以我們認為這是一個非常令人鼓舞的趨勢。

In terms of just market dynamics overall, looking at the category, we obviously watch what's happening from a competitive standpoint. We are aware and watching that KarXT will -- is up further PDUFA date later this year. That's a product that will likely be approved in just schizophrenia. You know, that's a situation where the product is now going to move from the promise really to the reality of the situation being in the market.

就整體市場動態而言，從該類別來看，我們顯然是從競爭的角度觀察正在發生的事情。我們知道並正在關注 KarXT 將在今年稍後進一步提高 PDUFA 日期。該產品可能僅被批准用於治療精神分裂症。您知道，在這種情況下，產品現在將從承諾真正轉變為市場上的現實。

What we know about schizophrenia is we have deep experience there. It's a complex market. We do expect that they will compete aggressively, and we are ready for that. That really doesn't change how we think about the profile for LYBALVI and really what our focus is on driving growth within schizophrenia and also within bipolar.

我們對精神分裂症的了解是我們對此有豐富的經驗。這是一個複雜的市場。我們確實預期他們會積極競爭，我們已為此做好準備。這確實不會改變我們對 LYBALVI 的看法，也不會改變我們對促進精神分裂症和躁鬱症患者成長的真正關注點。

Chris Shibutani, Goldman Sachs.

克里斯·澀谷，高盛。

Good morning. Thanks very much. With the enrollment timelines, we appreciated that in terms of thinking about how you move Vibrance-1 and Vibrance-2. I believe you would be the only program advancing into NT Type 2. Would we expect, therefore, that there's potential for a quicker pace of enrollment there given that opportunity?

早安.非常感謝。根據註冊時間表，我們很高興考慮如何移動 Vibrance-1 和 Vibrance-2。我相信您將是唯一進入 NT Type 2 的程式。因此，我們是否期望有機會加快那裡的入學速度？

And then secondly, you mentioned about some additional assets that you're looking to move in. How are you thinking about the potential to move into IH? I know you've made some comments before about the broader commercial considerations like IRA, but help us with some hints, possibly, on what you think would be your strategy for thinking about a different asset, more of a backup to NT1, NT2, or a different market target? Thank you.

其次，您提到了您希望搬入的一些其他資產。您如何看待進入 IH 的潛力？我知道您之前曾就 IRA 等更廣泛的商業考慮因素發表過一些評論，但請幫助我們提供一些提示，可能是您認為考慮不同資產的策略，更多的是 NT1、NT2 的備份，或者不同的市場目標？謝謝。

Yeah. Good morning, Chris, and thank you for the thoughtful questions. And they are thoughtful questions because I think what you're going to see in our company is an expansion of the prominence of this whole wakefulness circuitry in the brain and its relevance to underlying human disease.

是的。早安，克里斯，謝謝你提出的深思熟慮的問題。這些都是深思熟慮的問題，因為我認為您將在我們公司看到的是大腦中整個覺醒迴路的重要性及其與潛在人類疾病的相關性的擴展。

The core of the bullseye is narcolepsy, and narcolepsy is comprised of both NT1 and NT2. And what we're so pleased with, with the Vibrance-1 and Vibrance-2 studies, is that we're addressing narcolepsy with large -- with a range of doses that are contiguous, and that's important.

靶心的核心是嗜睡症，而嗜睡症由NT1和NT2組成。我們對 Vibrance-1 和 Vibrance-2 研究感到非常滿意的是，我們正在用大劑量的連續劑量來治療嗜睡症，這一點很重要。

One of the things we took away from the SLEEP Meeting in Houston where we presented these data, at least I took away, was a tremendous desire from the IH community for new medicines. It's a very underserved population. So we are actively really reconsidering what we're going to do with 2680 and follow on molecules that we're moving into the clinic in IH. We are going to be playing in IH. I can say that with some degree of certainty, and it's -- stay tuned for that.

我們從休士頓 SLEEP 會議中獲得的資訊之一是 IH 社區對新藥物的巨大渴望，在該會議上我們展示了這些數據，至少我是這樣。這是一個服務水準非常低的人群。因此，我們正在積極地重新考慮我們將如何使用 2680 並追蹤我們正在進入 IH 臨床的分子。我們將在 IH 比賽。我可以在一定程度上肯定地說這一點，請繼續關注。

The program writ large is going to expand, and you'll see more about that in the fall when we open up some of the kimono about what we're doing with our subsequent molecules and some of the disease areas that we're moving into. There's been an enormous amount of preclinical work that's going on over the last year and associated IP filings. So we're about ready to start talking about that publicly. So stay tuned. But I think you're going to see the program based on the data we've generated. It's been so encouraging in the early studies to see the program expand.

該計劃明顯將擴大，當我們在秋天打開一些關於我們正在對後續分子所做的事情以及我們正在進入的一些疾病領域時，你會看到更多關於這一點的信息。去年正在進行大量的臨床前工作以及相關的智慧財產權申請。所以我們準備開始公開討論這個問題。所以請繼續關注。但我認為您將看到基於我們生成的數據的程式。在早期研究中看到該計劃的擴展非常令人鼓舞。

Paul Matteis, Stifel.

保羅馬蒂斯，斯蒂菲爾。

Hey, this is James on for Paul. Thanks for taking our question. Maybe just one here. So we've seen some others talk about, you know, others with high kind of Medicaid exposure talk about, Medicaid disenrollment kind of being higher and impacting numbers, and VIVITROL had a great quarter this -- in 2Q. But just wondering if you can speak to any of the -- any dynamics there, if it's impacting you, or how we should think about kind of the rest of the year there? Thanks so much.

嘿，這是詹姆斯替補保羅。感謝您提出我們的問題。也許這裡只有一個。因此，我們看到其他一些人談論，你知道，其他醫療補助曝光率較高的人談論醫療補助退出人數較高且影響數字，VIVITROL 在第二季度表現出色。但只是想知道你是否可以談談那裡的任何動態，它是否對你產生影響，或者我們應該如何考慮今年剩下的時間？非常感謝。

Yes, absolutely, James. I'll take that one. You know, that's something that we watch very closely, Medicaid enrollment. We've watched that for years. We look at that not only for VIVITROL, but across our entire portfolio. And what we see is that the mix of business is not really experiencing any type of dramatic changes. We're going to continue to monitor, but at this point right now, we haven't seen any reduction in Medicaid claims across our product portfolio.

是的，絕對是，詹姆斯。我會接受那個。你知道，這是我們非常密切關注的事情，即醫療補助的註冊情況。我們已經關注這一點很多年了。我們不僅關注 VIVITROL 的這一點，還關注我們整個產品組合的這一點。我們看到的是，業務組合併沒有真正經歷任何類型的巨大變化。我們將繼續監控，但目前我們還沒有看到我們產品組合中的醫療補助索賠有任何減少。

Joseph Thome, TD Cowen.

約瑟夫·托姆，TD·考恩。

. Maybe a couple of tips on dosing for the orexin programs with some of the other competitive agents. We've seen that some of the AEs maybe attenuate with time or patients tolerize to the therapies, especially in relation to maybe insomnia or other things. Have you ever considered maybe doing dose titration, maybe to get to the target doses? Do you think that would help with AEs? Maybe why or why not?

。也許有一些關於與其他一些競爭性藥物一起進行食慾素治療的劑量建議。我們已經看到，一些不良事件可能會隨著時間的推移而減弱，或者患者對治療產生耐受，尤其是與失眠或其他問題有關的不良事件。您是否考慮過進行劑量滴定，以達到目標劑量？您認為這對 AE 有幫助嗎？也許為什麼或為什麼不呢？

And then when you think about the ideal number of doses to take forward to pivotal or commercial, is the goal from these Phase 2 is to identify one dose, or would you potentially take forward multiple?

然後，當您考慮推進關鍵或商業化的理想劑量時，第二階段的目標是確定一劑，還是可能會推進多劑？

And then just one quick question on the commercial side. Can you talk a little bit about the potential impact of those new contracts coming online July 1, maybe? What have you seen so far for LYBALVI and how should we think about maybe what kind of revenues that could unlock going forward? Thanks.

然後是一個關於商業方面的簡單問題。您能否談談 7 月 1 日上線的這些新合約的潛在影響？到目前為止，您對 LYBALVI 有何看法？謝謝。

I'll take the first two, and then I'll ask Todd to comment on the third. What's interesting about the data we've generated so far with ALKS 2680 is its tolerability profile is really good, and we've disclosed a lot of detail about that. And in NT1, the doses that we're using are quite low and quite well tolerated, and that can be the same also for NT2.

我將討論前兩個，然後我將請托德對第三個進行評論。迄今為止我們使用 ALKS 2680 產生的數據的有趣之處在於它的耐受性非常好，我們已經揭露了許多相關細節。在 NT1 中，我們使用的劑量相當低且耐受性很好，對於 NT2 也是如此。

So the way we're going to run the Phase 2 is in these fixed lanes of doses. And that's where we'll fully elaborate the tolerability profile over time, over a six-week period in a large number of patients. And then you'll have the information to say, is a titration necessary? Or our pretest hypothesis is that it won't be necessary.

因此，我們要進行第二階段的方式是在這些固定的劑量通道中。這就是我們將在六週內對大量患者進行全面闡述隨時間推移的耐受性概況的地方。然後您將獲得資訊來說明，是否需要滴定？或者我們的預測試假設是沒有必要。

But the virtue of having a range of contiguous doses that for any individual patient, then they have the ability to modulate the dose, they and their physician, to whatever level of activity or tolerability that is suitable for their particular circumstances.

但是，對於任何個別患者來說，擁有一系列連續劑量的優點是，他們和他們的醫生有能力將劑量調節到適合其特定情況的任何活性或耐受性水平。

So we think that's actually one of the major clinical advantages and ultimately the commercial advantages of the product. So therefore, answering your second question, for sure, we're interested in a range of doses for -- in a commercial presentation rather than a single dose because humans are variable and people's expectations and desires for the pharmacotherapy will vary. So it's a market that's suited for a range of well-tolerated options.

所以我們認為這實際上是該產品的主要臨床優勢和最終的商業優勢之一。因此，在回答你的第二個問題時，我們當然對商業演示中的一系列劑量感興趣，而不是單一劑量，因為人是可變的，人們對藥物治療的期望和願望也會有所不同。因此，這是一個適合一系列耐受性良好的選擇的市場。

Yeah. And I'll take the -- I'll provide a little bit of color just on how we're thinking about market access. You know, as I said in my prepared remarks, since the beginning of the year, we've added approximately 50 million additional lives, which is something that we're really excited about. This has been part of our strategy since the launch of the brand. So we're very focused right now on just optimizing the access profile, but the core element of this is really net sales. Right? So we look at net sales and profitability for each unit.

是的。我將提供一些有關我們如何考慮市場准入的資訊。你知道，正如我在準備好的演講中所說，自今年年初以來，我們已經增加了大約 5000 萬人的生命，這是我們真正感到興奮的事情。自品牌推出以來，這一直是我們策略的一部分。因此，我們現在非常專注於優化存取配置文件，但其核心要素實際上是淨銷售額。正確的？因此，我們關注每個單位的淨銷售額和獲利能力。

I can't get into a lot of detail in the specifics of the contracts for competitive reasons, and we're always having ongoing discussions overall, but it can take several quarters for these types of contracts to actually flow through all the way to the planned sponsors, all the way down at the local level. So that's something that we're actively managing right now, is just the pull-through and the push-through element of this.

出於競爭原因，我無法詳細介紹合約的具體細節，而且我們一直在進行總體討論，但這些類型的合約可能需要幾個季度才能真正落實到最終的結果。 。所以這就是我們現在正在積極管理的事情，就是其中的拉動和推動元素。

When we thought about our full year range, we did anticipate that we could have some movement in some of our contracting strategy. So if we think about just the guidance range overall, which is volume and gross to net, that really reflects and captures a range of scenarios. So we've already embedded the thinking and that we would have some positive market access changes into that range. And today, obviously, we reiterated what the guidance range would be for LYBALVI.

當我們考慮全年範圍時，我們確實預計我們的某些合約策略可能會發生一些變化。因此，如果我們只考慮總體指導範圍，即數量和毛淨值，它確實反映並捕捉了一系列場景。因此，我們已經融入了這樣的想法，我們將在該範圍內進行一些積極的市場准入變化。今天，顯然，我們重申了 LYBALVI 的指導範圍。

David Amsellem, Piper Sandler.

大衛·阿姆塞勒姆，派珀·桑德勒。

Hey, thanks. So, two questions. First, on LYBALVI, can you talk about how you're thinking about commercial spend as we move into '25? Is the salesforce right sized? Are you at steady state regarding DTC? Just talk about how you're thinking about that, particularly given the promotion sensitivity in the bipolar landscape. So that's number one.

嘿，謝謝。那麼，有兩個問題。首先，關於 LYBALVI，您能談談當我們進入 25 世紀時您如何看待商業支出嗎？銷售人員規模是否合適？DTC 是否處於穩定狀態？只需談談您對此的看法，特別是考慮到兩極格局中晉升的敏感度。所以這是第一。

And then secondly, on the Orexins, a high-level question. Richard, you talked about narcolepsy being in the bullseye, and then, of course, there's IH. But I'm wondering if, as you're thinking about additional molecules in the category and that you have in the portfolio, are there -- what other therapeutic adjacencies or even adjacent symptoms are you starting to think about as you broaden the development program in the class? Thanks.

其次，關於食慾素，這是一個高階問題。理查德，你談到了嗜睡症是靶心，當然，還有 IH。但我想知道，當您考慮該類別中的其他分子以及您在產品組合中的其他分子時，在擴大開發計劃時，您是否開始考慮其他哪些治療相鄰或甚至相鄰症狀在課堂裡？謝謝。

Yes, absolutely. So, I'll start first with just the commercial spend questions. Yes, for LYBALVI, strategically, we're focused on really three elements. And first and foremost, it's driving HCP adoption through depth and breadth. Secondly, it's building and driving patient awareness, which continues to grow through our DTC efforts. And then thirdly, it's optimizing the access profile.

是的，一點沒錯。因此，我先從商業支出問題開始。是的，對於 LYBALVI，從戰略上講，我們真正關註三個要素。首先也是最重要的是，它在深度和廣度上推動 HCP 的採用。其次，它正在建立和提高患者的意識，這種意識透過我們的 DTC 努力不斷提高。第三，它正在優化存取設定檔。

So that's not going to change going into '25. At this point, right now, we think our spend is appropriate with where the brand is, but as we move into '25, the market obviously is dynamic and we could add additional spend into '25 and it's something that we're looking at. But as at this point right now, we think the spend level is appropriate for where the brand is.

所以進入 25 年後這一點不會改變。目前，我們認為我們的支出與品牌所處的位置相適應，但隨著我們進入 25 年，市場顯然是動態的，我們可以在 25 年增加額外的支出，這是我們正在考慮的事情。但就目前而言，我們認為支出水準適合該品牌所處的位置。

And David on the Orexins without giving too much specificity until later this year, I'd say that there are three categories of adjacencies that immediately come to mind within the context of our CNS focus. One is in psychiatry, where the affect or the sleepiness or tiredness during the day is an important feature of certain psychiatric conditions.

大衛在今年晚些時候才對食慾素進行了詳細介紹，我想說，在我們關注中樞神經系統的背景下，我們會立即想到三類鄰接。一是在精神科領域，白天的情緒、困倦或疲倦是某些精神疾病的重要特徵。

The second is other neurological conditions where excessive sleepiness is a feature of the process, and then certain, even neurodevelopmental or neurodegenerative diseases, where that's also a major clinical feature. A number of these have relevant preclinical models, and so we've been mapping different compounds and different pharmacology onto those models, and that's what's maturing this year, and you'll hear more about.

第二種是其他神經系統疾病，其中過度嗜睡是該過程的一個特徵，然後是某些神經發育或神經退化性疾病，這也是一個主要的臨床特徵。其中許多都有相關的臨床前模型，因此我們一直在將不同的化合物和不同的藥理學映射到這些模型上，這就是今年成熟的模型，您會聽到更多相關資訊。

Marc Goodman, Leerink.

馬克‧古德曼，萊林克。

Yes. Rich, I heard you talk about business development. You mentioned commercial products that are already on the market. Obviously, those are pretty expensive. So, I was just curious, what level of transaction are you talking about here that's certainly a scenario? You know, are we talking about multiple billions? Are we talking about issuance of debt? Or how are you thinking about how big a product to do in the context of that, you know, and the share buyback that you're doing? Just give us a sense of how you're thinking about this.

是的。Rich，我聽到你談論業務發展。您提到了市場上已經存在的商業產品。顯然，這些都相當昂貴。所以，我只是很好奇，你在這裡談論的交易等級是什麼？你知道，我們談論的是數十億美元嗎？我們在談債務發行嗎？或者，在您正在進行的股票回購的背景下，您如何考慮要開發多大的產品？請告訴我們您是如何看待這個問題的。

Yes, Marc, it's -- I often say it's a target poor environment, but the targets that Wall Street has bid up significantly are not going to be targets for us. But with our specialized commercial infrastructure and our focus in addiction and in serious mental illness circumstances present themselves from time to time where you have assets that may not be major commercial products, but would drop a lot to our bottom line and would be a logical fit-in.

是的，馬克，我經常說這是一個目標環境不佳的情況，但華爾街大幅提高的目標不會成為我們的目標。但是，憑藉我們專業的商業基礎設施以及我們對成癮和嚴重精神疾病的關注，您所擁有的資產可能不是主要的商業產品，但會大大降低我們的底線，這將是一個合乎邏輯的選擇-在。

So I won't talk specifically about scale. I mean, obviously, we have a billion dollars of cash now. We're generating cash, and you know, we really don't see large merger of equal type transactions on the horizon at the moment and those are rare and rarely successful. But you know, I think that we have a specialized commercial infrastructure that we think is leverageable, and we'd be interested in doing that.

所以我不會具體談規模。我的意思是，顯然我們現在有十億美元的現金。我們正在產生現金，而且你知道，我們目前確實沒有看到同類交易的大型合併，而且這些合併很少見，也很少成功。但你知道，我認為我們擁有一個專業的商業基礎設施，我們認為它是可以利用的，我們有興趣這樣做。

So, the size is, we're not talking about major products. We're talking about just opportunistic type of deals that are small.

所以，尺寸是，我們不是在談論主要產品。我們談論的只是機會主義類型的小額交易。

Major being in the eye of the beholder. You know, I think that ones that could have a meaningful impact on EPS going forward it's -- sometimes you can do that over a series of deals or you could do it in one fell swoop, but we look at all those things.

主要是情人眼裡出西施。你知道，我認為那些可能對未來每股收益產生有意義的影響的——有時你可以透過一系列交易來做到這一點，或者你可以一下子做到這一點，但我們會考慮所有這些事情。

And then just on orexin, one question, and that is, you know, there's a lot of players, obviously, and you're one of the leaders right now. How do you see this playing out? I mean, you're talking about a strategy of multiple molecules, you know, probably moving into different indications. Is that how you see this, a very fragmented type of situation because there could be five different systems, I don’t know how we end Orexin’s, and there could be multiple products from each company. I mean, how are you envisioning this?

然後就食慾素而言，有一個問題，那就是，你知道，顯然有很多參與者，而你現在是領導者之一。您如何看待此事的進展？我的意思是，你正在談論多種分子的策略，你知道，可能會進入不同的適應症。這就是你所看到的情況，這是一種非常分散的情況，因為可能有五個不同的系統，我不知道我們如何結束 Orexin，並且每個公司可能有多種產品。我的意思是，你對此有何設想？

Well, I think there's an early mover advantage, and you know, not to make the direct analogy, but look what's happening in the GLP1 space, where if you make new medicines that are really value added for patients, there are huge commercial and clinical opportunities that present themselves. The chemistry space here, as you know, is limited. There are a number of aspirants, but there's not that many companies that have data that show that they're going to be meaningful competitors in this space.

嗯，我認為有一個先發優勢，你知道，不要做直接的類比，而是看看 GLP1 領域正在發生的事情，如果你製造出真正為患者增值的新藥，就會有巨大的商業和臨床價值出現的機會。如你所知，這裡的化學空間是有限的。有很多有抱負的公司，但沒有那麼多公司有數據表明他們將成為這個領域有意義的競爭對手。

So you know, I think that we can only rely on what we know in terms of the data that's been generated clinically. And we are in a very strong position, so we're going to move as fast as we can and cover as much of the waterfront as we can. So, I don't think at the end of the day, there's going to be lots and lots of players.

所以你知道，我認為我們只能依賴我們所知的臨床產生的數據。我們處於非常有利的地位，因此我們將盡可能快速地行動並覆蓋盡可能多的海濱地區。所以，我認為最終不會有很多很多的玩家。

I think there's too many optimization variables for the molecules, and I think better molecules will do better than inferior ones, and inferior ones won't find a place in the market as attractive as the ones that are better. So, we're going to exploit our advantage right now and move as quickly as we can. You know, Blair, I don't know if you have any thoughts on that as well.

我認為分子的最佳化變數太多，而且我認為更好的分子會比劣質分子做得更好，而劣質分子在市場上不會像更好的分子那樣有吸引力。因此，我們現在將利用我們的優勢並儘快採取行動。你知道，布萊爾，我不知道你對此是否也有任何想法。

No, I agree. I think we've already started to see that shake out in some of the early development, as we've seen competitors kind of come and go, and we would anticipate that moving forward.

不，我同意。我認為我們已經開始在一些早期開發中看到這種情況的發生，因為我們已經看到競爭對手來了又走，我們預計這種情況會繼續發展。

Joel Beatty, Baird.

喬爾·比蒂，貝爾德。

Hi, congrats on my quarter, and thanks for taking the questions. The first one is on LYBALVI. What trends have you been seeing in the split of scripts between bipolar versus schizophrenia? And then on Vibrance-1, I believe this is a six-week randomized controlled trial followed by a seven-week extension phase. What is the design of that extension phase, particularly as it relates to how dose adjustments will be allowed and how that could add to a differentiated profile compared to other agents that may not have that same type of dose ranging available?

您好，恭喜我的季度，感謝您提出問題。第一個是在 LYBALVI 上。您在雙極性情感障礙與精神分裂症之間的劇本劃分中發現了哪些趨勢？然後在 Vibrance-1 上，我相信這是一項為期六週的隨機對照試驗，隨後是為期七週的擴展階段。這個延長階段的設計是什麼，特別是因為它涉及如何允許劑量調整，以及與可能不具有相同類型劑量範圍的其他藥物相比如何增加差異化特徵？

Yes, absolutely. I'll start with LYBALVI split, kind of the contribution to business, which has been relatively stable over the last, you know, two quarters. We saw some similar patterns from Q1. So overall, the split still in terms of overall TRx's is approximately 50:50 between schizophrenia and bipolar. The movement that we're starting to see and it's becoming more pronounced as we headed into this year, is just with new patient starts. So, when you look at just overall share of NBRx's quarter-over-quarter, Bipolar 1 disorder prescriptions for new patient starts represent about 57% right now.

是的，一點沒錯。我將從 LYBALVI 拆分開始，這是對業務的貢獻，在過去兩個季度中相對穩定。我們在第一季看到了一些類似的模式。因此，總體而言，精神分裂症和躁鬱症之間的整體 TRx 比例仍然約為 50:50。我們開始看到的這種變化，隨著今年的到來，這種變化變得更加明顯，這只是新患者開始出現的情況。因此，當您僅查看 NBRx 季度環比的整體份額時，目前為新患者開出的雙相 1 型情感障礙處方約佔 57%。

Obviously, year-over-year and quarter-over-quarter, we saw some really robust volume growth for bipolar and schizophrenia. But new patient starts, we're clearly seeing a leading indicator with bipolar right now. So, it's very encouraging for us. It's part of our long-term strategy, obviously through HCP adoption, also through our DTC campaign.

顯然，與去年同期相比和上一季相比，我們看到雙相情感障礙和精神分裂症的銷售確實出現了強勁的增長。但是新患者開始了，我們現在顯然看到了雙相情感障礙的領先指標。所以，這對我們來說非常鼓舞人心。這是我們長期策略的一部分，顯然是透過 HCP 的採用以及我們的 DTC 活動實現的。

And your question about the Vibrance-1 extension is insightful and I think it's beginning to reveal what some of the potential advantages of C could be. So, indeed, in the seven-week extension phase, when people are done with the fixed lanes of the six-week randomized, controlled aspect of it, they can -- patients can opt for dose adjustment between the 4 milligram, 6 milligram and 8 milligram doses.

你關於 Vibrance-1 擴展的問題很有洞察力，我認為它開始揭示 C 的一些潛在優勢。因此，事實上，在七週的延長階段，當人們完成了六週隨機、對照方面的固定泳道時，他們可以——患者可以選擇在 4 毫克、6 毫克和8毫克劑量。

So, it'll be really interesting to see how that settles out, particularly if we do see an attenuation of side effects over time and the tolerability profile as favorable as it has the potential to be. It'll be really interesting to see those data. We'll take that type of learning from that and the open label safety study that we'll run independently of that, all that information will go into designing the phase 3 protocol.

因此，看看這將如何解決將是非常有趣的，特別是如果我們確實看到副作用隨著時間的推移而減弱並且耐受性概況盡可能有利的話。看到這些數據會非常有趣。我們將從中吸取這種教訓，並獨立進行開放標籤安全性研究，所有這些資訊都將用於設計第三階段協議。

Akash Tewari, Jefferies.

阿卡什·特瓦里，杰弗里斯。

Hey, it's Manoj on for Akash. On your orexin program at SLEEP earlier this year, you had around 60% insomnia at the 8-milligram high dose in NT1. Where do you think this could be like these rates could end up with longer term dosing. What's an acceptable rate? And also, did you see any similar rates of insomnia in your NT2 -- IH data? Thanks.

嘿，Manoj 代表 Akash 上場。在今年稍早的 SLEEP 食慾素計畫中，服用 8 毫克高劑量 NT1 後，約 60% 的人出現失眠。您認為這些利率最終可能會以長期劑量的形式出現在哪裡？可接受的費率是多少？另外，您在 NT2 - IH 數據中是否看到任何類似的失眠率？謝謝。

Yes, I don't have the data immediately at hand, but I think one of the interesting things from competitive data that was shown at SLEEP in Houston was the attenuation of the side effect of insomnia after the first week. So, we think that's probably more of a class-wide phenomenon as patients get accustomed to being on orexin agonist. Our overall rates of insomnia were very acceptable and dose dependent. So, what we hear from clinicians is what I just mentioned, which is that you see an attenuation of it in real life over time, and we'll more fully elaborate all that in our Phase 2 study.

是的，我手頭上沒有立即的數據，但我認為休士頓 SLEEP 上顯示的競爭數據中有趣的事情之一是第一週後失眠副作用的減弱。因此，我們認為這可能是全類現象，因為患者已經習慣了服用食慾素激動劑。我們的整體失眠率是非常可以接受的並且依賴於劑量。因此，我們從臨床醫生那裡聽到的就是我剛才提到的，隨著時間的推移，你會在現實生活中看到它的減弱，我們將在第二階段研究中更全面地闡述所有這些。

Jason Gerberry, Bank of America.

傑森‧格伯里，美國銀行。

Hey, good morning. Thanks for taking my questions. I guess first one is on ARISTADA and if there's any expectation that gross to nets, if they should be relatively stable next year, you know, when IRA shifts the catastrophic coverage costs onto payer plans, there's sort of an open debate of is there a risk that rebates materially increase in that category?

嗨，早安。感謝您回答我的問題。我想第一個是關於 ARISADA 的，如果有人預計淨收入總額是否會在明年相對穩定，你知道，當 IRA 將災難性保險成本轉移到付款人計劃上時，存在某種公開辯論：是否存在該類別的回扣大幅增加的風險？

And then my second question on the Orexins in lieu of Takeda's data and roughly mid 20 minutes MWT's placebo adjusted, should the street be focusing on this metric as the key area for differentiation in NT1? Or do you think that, you know, it's really more about a broader risk benefit evaluation and having breadth of indications like NT2 and IH, you know, that's ultimately kind of your area of focus? Thanks.

然後我的第二個問題是關於 Orexins 的，而不是 Takeda 的數據和大約 20 分鐘中期 MWT 的安慰劑調整，街道是否應該關注這個指標作為 NT1 差異化的關鍵領域？或者您認為，您知道，這實際上更多的是更廣泛的風險收益評估以及 NT2 和 IH 等適應症的廣泛性，您知道，這最終是您關注的領域？謝謝。

Yes. Hey, Jason, it's Todd. I'll start with ARISTADA with gross to net. It's -- this quarter and for the full year, it's relatively stable. Next year, there'll be some marginal increases. Obviously, we're very in-tune to the implications of the IRA. The way we're really thinking about that is there's really minimal impact in the near and mid-term across our portfolio. We don't expect that we're going to have significant inflation penalties because obviously we do very responsible pricing actions. None of our medicines are going to be part of the Medicare Part D negotiations.

是的。嘿，傑森，我是托德。我將從 ARISADA 開始，總淨值。本季和全年都相對穩定。明年，會有一些邊際成長。顯然，我們非常了解 IRA 的影響。我們真正考慮的方式是，在我們的投資組合的近期和中期影響確實很小。我們預計不會受到嚴重的通膨懲罰，因為顯然我們採取了非常負責任的定價行動。我們的任何藥物都不會成為醫療保險 D 部分談判的一部分。

And in terms of the Part D redesign, keep in mind that our company Alkermes that we're classified as a specified small manufacturer. So, that enables us to a phase end in terms of the overall liability. So, it's very manageable for us and mitigates our risk starting in 2025.

在 D 部分重新設計方面，請記住我們的 Alkermes 公司被歸類為指定的小型製造商。因此，這使我們能夠在整體責任方面結束階段。因此，從 2025 年開始，這對我們來說非常容易管理，並降低了我們的風險。

And this is Rich. I'll take the question about the Orexin. I think the way to think about the category is the Orexins relative to what precedes them and then the Orexins relative to each other. In the former category, you know, MWT's that have been shown by Takeda and others, they're really good, they're really beneficial for patients. But recognize that MWT, the maintenance of wakefulness value is really just one dimension of the experience of being on a medicine for the treatment of a serious condition.

這是里奇。我將回答有關食慾素的問題。我認為思考這個類別的方法是食慾素相對於它們之前的類別，然後是食慾素之間的相對關係。在前一類中，您知道，武田和其他公司已經證明了 MWT 非常好，對患者確實有益。但要認識到，MWT（維持清醒值）實際上只是服用藥物治療嚴重疾病的體驗的一個方面。

It's an important metric. It's an approvable metric and has the virtue of being, you know, so quantitative. But I think relative to each other, if you stipulate that more than one orexin agonist crosses the finish line, then the question becomes them relative to each other. And this is exactly where a range of doses, tolerability and then also a range of indications.

這是一個重要的指標。這是一個值得認可的指標，並且具有量化的優點。但我認為相對於彼此，如果你規定不只一種食慾素激動劑衝過終點線，那麼問題就變成了它們相對於彼此。這正是劑量範圍、耐受性以及適應症範圍的所在。

So the differential diagnosis doesn't have to be quite so precise between NT1 or NT2 or IH. You basically have agents that can be dosed at multiple doses across a range of those indications. I think that's where the competitive dynamic really gets sharpened.

因此，NT1、NT2 或 IH 之間的鑑別診斷不必非常精確。基本上，您擁有可以針對一系列適應症進行多次給藥的藥物。我認為這就是競爭動態真正變得更加激烈的地方。

Jessica Fye, JPMorgan.

潔西卡法耶，摩根大通。

Hi, this is Na Sun on for Jessica Fye. Just wanted to ask about ARISTADA. First, was there an inventory benefit for ARISTADA, specifically in the quarter? And second, can you talk about what gives you confidence of hitting the guidance range for that product this year? Thanks.

大家好，我是 Jessica Fye 的孫娜。只是想問阿里斯塔。首先，ARISADA 是否有庫存效益，特別是在本季？其次，您能否談談是什麼讓您有信心今年達到該產品的指導範圍？謝謝。

Hi, Na Sun, this is Blair. With regards to inventory, just like with our other programs in Q1, we had a shortfall of inventory purchases, and so we saw with ARISTADA a rebound into Q2. The net effect of that for across the quarters was $2 million.

嗨，孫娜，我是布萊爾。關於庫存，就像我們第一季的其他計劃一樣，我們的庫存採購出現短缺，因此我們看到 ARISADA 在第二季度出現反彈。整個季度的淨效應為 200 萬美元。

Yes. In terms of just the outlook for ARISTADA today, obviously we reiterated our guidance range. Obviously, you know, we're watching dynamics in the market right now, and the way we're thinking about it over the last several quarters. Last year, it's been a -- it has been a dynamic market for the LAI category.

是的。就今天 ARISADA 的前景而言，我們顯然重申了我們的指導範圍。顯然，你知道，我們現在正在關注市場的動態，以及我們在過去幾季的思考方式。去年，LAI 類別的市場充滿活力。

What we're most interested in is the performance and outlook for ARISTADA. The last two quarters, Q1 and Q2, we've seen some encouraging trends with new to brand prescriptions. So, we saw that within the category, and we've seen that within ARISTADA. Secondly is we've seen encouraging trends within our non-retail sector, for ARISTADA as well, too. So those give us a lot of confidence that we're right on track to achieve our objectives for the year.

我們最感興趣的是 ARISADA 的表現和前景。在過去的兩個季度，即第一季和第二季度，我們看到了一些新品牌處方的令人鼓舞的趨勢。所以，我們在類別中看到了這一點，並且在 ARISADA 中也看到了這一點。其次，我們在非零售領域看到了令人鼓舞的趨勢，對於 ARISADA 來說也是如此。因此，這些給了我們很大的信心，我們相信我們正在實現今年的目標。

Great. Rob, we have time for one more question.

偉大的。羅布，我們還有時間再問一個問題。

Douglas Tsao, H. C. Wainwright.

道格拉斯·曹（Douglas Tsao），H.C.溫賴特（H.C.Wainwright）。

Hi, good morning. Thanks for taking the questions and sneaking me in. Maybe, Richard, starting with IH, I think you noted the importance of your finding that there -- you know, that you can have an impact on patients with normal orexin levels.

早安.感謝您提出問題並偷偷帶我進來。也許，理查德，從 IH 開始，我認為您注意到了您的發現的重要性 - 您知道，您可以對食慾素水平正常的患者產生影響。

I'm just curious, when you think about sort of follow on molecules or different molecules to develop, would they have, obviously there's sort of a strategic value from an IRA perspective and commercial perspective, but I'm just curious, from a pharmacology perspective, just given that difference of normal orexin levels, would there be other tweaks to the molecule that you would make that would make it a better suited molecule for IH versus what some others are doing, we sort of pursuing it sort of more of a one-size-fits-all approach?

我只是很好奇，當你考慮對分子或不同分子進行後續開發時，它們會嗎？來看從角度來看，考慮到正常食慾素水平的差異，是否會對您製作的分子進行其他調整，使其成為與其他人正在做的相比更適合IH 的分子，我們有點追求它更像是一刀切的方法？

Hey, Douglas, I don't think I'm prepared to answer that question publicly at this moment. I think that there's some learnings that we're learning both clinically and preclinically that inform that decision. But I'm not quite ready to go there yet.

嘿，道格拉斯，我認為我現在不准備公開回答這個問題。我認為我們在臨床和臨床前學到的一些知識可以為我們的決定提供資訊。但我還沒準備好去那裡。

Other than to say what I said earlier, which is that I think we're pretty convinced that IH is a separate opportunity from narcolepsy. You might be lulled into thinking that NT2 and IH are interchangeable, but I think the more time that we spend with patients and clinicians treating patients with a differential diagnosis, they are different patients. And, you know, a single drug could be useful, but also more than one drug may be useful as well.

除了我之前所說的之外，我認為我們非常確信 IH 是與發作性睡病不同的機會。您可能會誤以為 NT2 和 IH 是可以互換的，但我認為我們花在患者和臨床醫生身上的時間越多，透過鑑別診斷來治療患者，他們就是不同的患者。而且，您知道，一種藥物可能有用，但多種藥物也可能有用。

Okay, great. And then just as a follow-up, I mean, obviously there have been questions around the impact of KarXT. I'm just curious, from talking to clinicians, do you get a sense that they are targeting sort of the different patients that are the two drugs that sort of go after initially different patient sets, meaning LYBALVI in the early going, just because obviously they're very different drugs and LYBALVI has the sort of proven efficacy of olanzapine? Thank you.

好的，太好了。我的意思是，作為後續行動，顯然人們對 KarXT 的影響有疑問。我只是很好奇，從與臨床醫生的交談中，你是否感覺到他們針對的是不同的患者，這兩種藥物最初是針對不同的患者群體的，這意味著早期的 LYBALVI，只是因為顯然它們是非常不同的藥物，LYBALVI 具有奧氮平的那種已被證實的功效嗎？謝謝。

Yes, I mean, just coming back to just KarXT in general, it's yet to be determined. First, you know, we've got to see the product has to get approved and there has to be a label. And obviously the company would have to promote on label right now. And it really -- it doesn't really change how we think about LYBALVI. That's most important to us.

是的，我的意思是，回到 KarXT 的整體情況來看，目前尚未確定。首先，你知道，我們必須看到產品必須獲得批准並且必須有標籤。顯然，該公司現在必須在標籤上進行促銷。事實上，它並沒有真正改變我們對 LYBALVI 的看法。這對我們來說是最重要的。

LYBALVI has a broad label, which is a huge benefit for the brand. And, you know, as I said earlier, if you just look at the underlying trends, we see a really healthy, strong mix across schizophrenia and bipolar. So, we think the addressable population is very large for LYBALVI.

LYBALVI 擁有廣泛的標籤，這對品牌來說是一個巨大的優勢。而且，你知道，正如我之前所說，如果你只看潛在的趨勢，我們會看到精神分裂症和躁鬱症之間的真正健康、強烈的結合。因此，我們認為 LYBALVI 的目標族群非常多。

And in terms of the growth you're seeing for schizophrenia, is that coming from new prescribers or just greater depth within the existing prescriber base? Thank you.

就您所看到的精神分裂症的增長而言，這是來自新的處方醫生還是只是現有處方醫生基礎的更深入？謝謝。

Yes, absolutely. We're seeing depth of prescribing really grow within our existing prescriber base. And it's healthy right now if you look at a quarter-over-quarter and year-over-year, and it's very consistent with the market research. Prescribers tell us once they start on LYBALVI, they get a positive experience, which we're hearing a lot of that, very positive experiences from HCPs and patients that they will prescribe utilization. So, we see a lot of the depth being driven by existing prescribers while driving breadth at the same time.

是的，一點沒錯。我們看到我們現有的處方者基礎中處方的深度確實在增長。如果你看看環比和同比，現在它是健康的，並且與市場研究非常一致。處方醫生告訴我們，一旦他們開始使用 LYBALVI，他們就會獲得積極的體驗，我們從 HCP 和患者那裡聽到了很多這樣的非常積極的體驗，他們會開處方使用。因此，我們看到現有處方者在推動廣度的同時，也正在推動深度的發展。

Thank you. We have reached the end of the question-and-answer session, and I'll now turn the call over to Sandy Coombs for closing remarks.

謝謝。問答環節已經結束，我現在將電話轉交給桑迪·庫姆斯進行總結發言。

Great. Thanks everyone, for joining us on the call today. Please don't hesitate to reach out to us at the company if you have any follow-up questions. Have a great day.

偉大的。感謝大家今天加入我們的電話會議。如果您有任何後續問題，請隨時與我們公司聯絡。祝你有美好的一天。

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.

今天的會議到此結束。此時您可以斷開線路。感謝您的參與。