Indivior Pharmaceuticals Inc (INDV) 2026 Q1 法說會逐字稿

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  • Operator

    Operator

  • Good day and thank you for standing by. Welcome to the Indivior Pharmaceuticals Q1 2026 financial results conference call and webcast.

    各位早安,感謝您撥冗等候。歡迎參加 Indivior Pharmaceuticals 2026 年第一季財務業績電話會議與網路直播。

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

    (接線員指示)敬請注意,今日會議將進行錄音。

  • I would now like to hand the conference over to our first speaker today, Jason Thompson. Please go ahead.

    現在我想將會議交給今天的第一位講者 Jason Thompson。請開始。

  • Jason Thompson - Vice President - Investor Relations

    Jason Thompson - Vice President - Investor Relations

  • Thanks, [Nadia]. Welcome to Indivior's first-quarter 2026 results conference call.

    謝謝,[Nadia]。歡迎參加 Indivior 2026 年第一季業績電話會議。

  • I'm joined today by Joe Ciaffoni, Chief Executive Officer; Pat Barry, Chief Commercial Officer; Ryan Preblick, Chief Financial Officer; and Christian Heidbreder, our Chief Scientific Officer.

    今天與我一同出席的有:執行長 Joe Ciaffoni;商務長 Pat Barry;財務長 Ryan Preblick;以及科學長 Christian Heidbreder。

  • Before we begin, I need to remind everyone that, on today's call, we may make forward-looking statements that are subject to risks and uncertainties and that actual results may differ materially. We list the factors that may cause our results to be materially different, here, on slide 2 of this presentation.

    在開始之前,我需要提醒各位:在今天的電話會議中,我們可能會做出前瞻性陳述,這些陳述受風險與不確定性影響,實際結果可能會有重大差異。我們在本簡報第 2 頁投影片列示了可能導致結果出現重大差異的因素。

  • We also may refer to non-GAAP measures, the reconciliations for which may also be found in the appendix of this presentation that is now posted on our website at indivior.com.

    我們也可能會提及非 GAAP 指標,其調節表亦可在本簡報附錄中找到;該簡報現已發布於我們的網站 indivior.com。

  • I'll now turn the call over to Joe Ciaffoni, our CEO.

    接下來我將把電話會議交給我們的執行長 Joe Ciaffoni。

  • Joseph Ciaffoni - Chief Executive Officer, Director

    Joseph Ciaffoni - Chief Executive Officer, Director

  • Thanks, Jason. Good morning and thank you for joining us on today's call to review our first-quarter results.

    謝謝你,Jason。各位早安,感謝各位參加今天的電話會議,一同回顧我們第一季的業績。

  • I will begin with an overview of our performance and summarize our progress against Phase II, Accelerate, of the Indivior Action Agenda. Pat will discuss SUBLOCADE performance. Christian will provide an update on the pipeline. Ryan will review the financials.

    我將先概述我們的表現,並總結我們在 Indivior 行動議程第二階段「加速」(Phase II, Accelerate)的進展。Pat 將說明 SUBLOCADE 的表現。Christian 將提供研發管線更新。Ryan 將回顧財務表現。

  • In the first quarter, we made significant progress in Phase II of the Indivior Action Agenda and executed key elements of our capital deployment strategy. Specifically, in the quarter, we grew total net revenue 19% year over year to $317 million, primarily driven by strong US SUBLOCADE performance.

    第一季,我們在 Indivior 行動議程第二階段取得顯著進展,並執行了資本配置策略的關鍵要素。具體而言,本季我們的總淨營收年增 19% 至 3.17 億美元,主要由美國 SUBLOCADE 的強勁表現所帶動。

  • We grew total SUBLOCADE net revenue 32% year over year to $232 million, reflecting strong year-over-year dispense unit growth of 20%.The acceleration in SUBLOCADE dispense unit growth was driven by improved commercial execution and the early impact that our new consumer campaign, Move Forward in Recovery, is having on patient activation.

    我們的 SUBLOCADE 總淨營收年增 32% 至 2.32 億美元,反映出發藥單位(dispense unit)年增 20% 的強勁成長。SUBLOCADE 發藥單位成長的加速,來自商業執行的改善,以及我們新的消費者活動「Move Forward in Recovery」對病患啟動(patient activation)所帶來的早期影響。

  • Importantly, SUBLOCADE category share was stable in the quarter. We had record new patient starts.

    重要的是,SUBLOCADE 的品類市占率在本季維持穩定。我們的新病患起始(new patient starts)創下紀錄。

  • We delivered adjusted EBITDA of $164 million, up 112% year over year; and margin improvement of 23 percentage points.

    我們的調整後 EBITDA 為 1.64 億美元,年增 112%;利潤率提升 23 個百分點。

  • We successfully executed our capital deployment strategy, improving our debt profile through the issuance of $500 million of convertible notes and returned value to our shareholders by repurchasing $125 million of our shares at an average price of $31.45.

    我們成功執行資本配置策略,透過發行 5 億美元可轉換公司債改善債務結構,並以平均每股 31.45 美元回購 1.25 億美元股份,向股東回饋價值。

  • Our strong first-quarter performance and the underlying strength of SUBLOCADE across key metrics, along with a more favorable outlook for SUBOXONE, enabled us to meaningfully raise our 2026 financial guidance.

    我們第一季的強勁表現,以及 SUBLOCADE 在關鍵指標上的基本面強度,再加上 SUBOXONE 較為有利的展望,使我們得以大幅上調 2026 年財務指引。

  • I want to thank the Indivior team for their contributions to our progress against the Indivior Action Agenda; and for their commitment to making a positive difference in the lives of people living with opioid use disorder and the communities we serve.

    我要感謝 Indivior 團隊對推動 Indivior 行動議程進展所做的貢獻;也感謝大家致力於為受鴉片類藥物使用障礙影響的人們及我們所服務的社區帶來正向改變。

  • In Phase II, Accelerate, we are focused on accelerating US SUBLOCADE dispense unit growth and net revenue throughout 2026; and growing adjusted EBITDA and cash flow at an even faster rate.

    在第二階段「加速」中,我們聚焦於在 2026 年加速美國 SUBLOCADE 發藥單位成長與淨營收成長;並以更快的速度提升調整後 EBITDA 與現金流。

  • In the first quarter, we achieved a major milestone: over 500,000 patients in the US have been prescribed SUBLOCADE since its launch in 2018. Nearly one-quarter of those patients were added in the last five quarters, underscoring SUBLOCADE's strong growth trajectory.

    第一季我們達成一項重大里程碑:自 2018 年上市以來,美國已有超過 50 萬名病患被處方 SUBLOCADE。近四分之一的病患是在最近五個季度新增,凸顯 SUBLOCADE 強勁的成長軌跡。

  • SUBLOCADE is the first and number 1 prescribed long-acting injectable for the treatment of moderate-to-severe opioid use disorder. It is the only monthly long-acting injectable with an indication for rapid initiation.

    SUBLOCADE 是首個且為治療中度至重度鴉片類藥物使用障礙之處方量排名第 1 的長效注射劑(long-acting injectable)。它也是唯一具備「快速起始」(rapid initiation)適應症的每月長效注射劑。

  • Looking forward, we believe continuous improvement in commercial execution; and our commitment to significant and sustained investment in our new direct-to-consumer campaign will accelerate US SUBLOCADE dispense unit growth to the mid-teens in 2026, up from 7% in 2025.

    展望未來,我們相信商業執行的持續改善,以及我們承諾對新的直接面向消費者(DTC)活動進行重大且持續的投資,將使 2026 年美國 SUBLOCADE 發藥單位成長加速至十位數中段(mid-teens),高於 2025 年的 7%。

  • We now expect total SUBLOCADE net revenue to grow 13% year over year to $970 million at the midpoint of our guidance.

    我們目前預期 SUBLOCADE 總淨營收在指引中點將年增 13% 至 9.70 億美元。

  • As expected, our new operating model established in Phase I, Generate Momentum, of the Indivior Action Agenda is accelerating the growth of adjusted EBITDA and cash flow at a significantly faster rate than net revenue.

    如預期所示,我們在 Indivior 行動議程第一階段「建立動能」(Phase I, Generate Momentum)所建立的新營運模式,正以顯著快於淨營收的速度,加速調整後 EBITDA 與現金流的成長。

  • We now expect to generate $640 million of adjusted EBITDA in 2026 at the midpoint of our guidance, up 50% versus the previous year, which equates to a 51% margin, up 16 percentage points versus 2025.

    我們目前預期 2026 年調整後 EBITDA 在指引中點將達 6.40 億美元,較前一年成長 50%,相當於 51% 的利潤率,較 2025 年提升 16 個百分點。

  • Our increased cash flow and improved financial flexibility position us to strategically deploy capital to create value for our shareholders. With the completion of our debt refinancing, our capital deployment priorities are focused on opportunistically utilizing the remaining $270 million of our share repurchase program and evaluating commercial stage business development opportunities to enhance and diversify Indivior's growth profile.

    我們增加的現金流與改善的財務彈性,使我們能策略性地配置資本以為股東創造價值。隨著債務再融資完成,我們的資本配置優先事項聚焦於把握時機運用剩餘 2.70 億美元的庫藏股回購計畫額度,並評估商業化階段的業務開發機會,以強化並多元化 Indivior 的成長輪廓。

  • We are on track to enter Phase III of the Indivior Action Agenda, Breakout, in the second half of this year.

    我們正按計畫於今年下半年進入 Indivior 行動議程第三階段「突破」(Phase III, Breakout)。

  • Next, I want to briefly touch on the decisions we made on the INDV-6001 and INDV-2000 programs. We do not intend to pursue Phase III development of INDV-6001 and have amended our license agreement with Alar Pharmaceuticals.

    接下來,我想簡要談談我們對 INDV-6001 與 INDV-2000 專案所做的決策。我們不打算推進 INDV-6001 的第三期(Phase III)開發,並已修訂與 Alar Pharmaceuticals 的授權協議。

  • Pursuant to these amendments, Alar will regain development rights to the asset and commercialization rights outside of the US. Indivior will maintain commercial rights in the US.

    依據這些修訂,Alar 將重新取得該資產的開發權,以及美國以外地區的商業化權利。Indivior 將保留美國的商業權利。

  • Regarding INDV-2000, it did not meet the primary endpoint in the Phase II trial. Additional work is needed to further explore the initial signals we observed.

    至於 INDV-2000,其在第二期(Phase II)試驗中未達主要終點(primary endpoint)。仍需進一步工作,以更深入探索我們所觀察到的初步訊號。

  • We will not be progressing the program internally for opioid use disorder. We will pursue external business development opportunities for this asset. Christian will provide more detail.

    我們不會在內部推進該專案用於鴉片類藥物使用障礙。我們將為此資產尋求外部業務開發機會。Christian 將提供更多細節。

  • I want to recognize and thank our R&D colleagues for leading with science and for the hard work they put into the 6001 and 2000 programs. Their efforts greatly advanced our understanding of these assets. Their work was high quality and conducted with integrity.

    我要肯定並感謝我們的研發同仁以科學為本的領導,以及他們在 6001 與 2000 專案上投入的辛勤努力。他們的付出大幅提升了我們對這些資產的理解。他們的工作品質優良,且以誠信方式執行。

  • To conclude, we are encouraged by our progress, so far, in 2026. Our results strongly position us to achieve our financial and operational objectives in Phase II, Accelerate, and to enter Phase III, Breakout, in the second half of 2026.

    總結而言,我們對 2026 年迄今的進展感到振奮。我們的業績使我們具備強而有力的基礎,以達成第二階段「加速」的財務與營運目標,並在 2026 年下半年進入第三階段「突破」。

  • I'll now turn the call over to Pat.

    接下來我把電話會議交給 Pat。

  • Patrick Barry - Chief Commercial Officer

    Patrick Barry - Chief Commercial Officer

  • Thanks, Joe.

    謝謝你,Joe。

  • Our commercial teams are executing well against Phase II of the Indivior Action Agenda, Accelerate. This acceleration is being driven by our commercial-execution initiatives and our consumer-activation investments; notably, our successful DTC campaign, Move Forward in Recovery.

    我們的商業團隊正有效執行 Indivior 行動議程第二階段「加速」。這項加速由我們的商業執行計畫與消費者啟動投資所驅動;尤其是我們成功的 DTC 活動「Move Forward in Recovery」。

  • We achieved record new patient starts in the first quarter of approximately 31,800, a year-over-year increase of 29%. This brought our total US SUBLOCADE patients treated over the last 12 months to 191,600 at the end of the first quarter.

    第一季我們的新病患起始(new patient starts)約 31,800 人,年增 29%,創下紀錄。這使得截至第一季末,過去 12 個月在美國接受 SUBLOCADE 治療的病患總數達到 191,600 人。

  • Dispense unit growth in the first quarter was up 20% versus the prior year, reflecting acceleration in US SUBLOCADE versus 2025. Total category share of LAIs in the US for SUBLOCADE remained stable at 76%.

    第一季發藥單位成長較去年同期增加 20%,反映美國 SUBLOCADE 相較 2025 年的加速成長。SUBLOCADE 在美國長效注射劑(LAIs)品類的總市占率維持穩定,為 76%。

  • We continued our track record of growing the number of SUBLOCADE prescribers, which is an important leading indicator for overall LAI category and SUBLOCADE growth. We exited the first quarter with a record number of active SUBLOCADE prescribers and those treating five or more patients.

    我們延續了增加 SUBLOCADE 處方醫師數量的良好紀錄;這是整體長效注射劑(LAI)類別與 SUBLOCADE 成長的重要領先指標。我們在第一季結束時,活躍的 SUBLOCADE 處方醫師數量,以及治療五位或以上病患的處方醫師數量,皆創下新高。

  • Total active SUBLOCADE prescribers grew 19%, year over year. HCPs treating five or more patients grew 20%, year over year.

    活躍的 SUBLOCADE 處方醫師總數年增 19%。治療五位或以上病患的醫療照護專業人員(HCP)年增 20%。

  • While we are encouraged by the progress in US SUBLOCADE, we see continued opportunity to drive further acceleration through our commercial improvement, consumer activation, and public policy initiatives.

    儘管我們對 SUBLOCADE 在美國的進展感到鼓舞,我們仍看到持續的機會,可透過商業改善、消費者啟動以及公共政策倡議,進一步推動加速成長。

  • First, SUBLOCADE is the only monthly long-acting injectable with an indication for rapid initiation on day 1 and a second dosing as early as day 8. Our focus on delivering the second dose as early as day 8 is driving increased adoption.

    首先,SUBLOCADE 是唯一一款每月一次的長效注射劑,且其適應症標示允許於第 1 天快速起始,並可最早於第 8 天進行第二次給藥。我們聚焦於最早在第 8 天提供第二劑,正帶動採用率提升。

  • Providers' recognition of SUBLOCADE's differentiated label continues to grow, particularly as synthetic opioids remain prevalent in the US. Approximately 9% of new patients are receiving the accelerated second dose and 23% of active HCPs have begun prescribing a second dose, in line with the expanded SUBLOCADE label.

    醫療提供者對 SUBLOCADE 差異化標示的認知持續提升,尤其是在合成類鴉片藥物於美國仍普遍存在的情況下。約有 9% 的新病患正在接受加速的第二劑給藥,且 23% 的活躍 HCP 已開始開立第二劑處方,與擴增後的 SUBLOCADE 標示一致。

  • Second, our commercial channel-productivity initiative is generating results. We executed five enhanced service agreements with key specialty pharmacies and have started to see steady improvement in commercial dispense yields.

    第二,我們的商業通路生產力提升計畫正在產生成果。我們與關鍵專科藥局簽署了五項強化服務協議,並已開始看到商業端調劑(dispense)產出率穩定改善。

  • Third, consumer activation remains strong. We continue to invest behind SUBLOCADE through our DTC campaign, Move Forward in Recovery. Patient engagement stayed elevated throughout the quarter, with more than 1,200 new CRM enrollments each month, bringing total engaged consumers to over 8,300 since launch.

    第三,消費者啟動仍然強勁。我們持續透過直接面向消費者(DTC)的「Move Forward in Recovery」活動加大對 SUBLOCADE 的投資。整個季度病患互動維持在高檔,每月新增超過 1,200 名 CRM 註冊,使自活動推出以來的互動消費者總數超過 8,300 人。

  • Paid search volumes remain above pre-campaign levels, with category-leading share of voice across core search terms. Additionally, over 30,000 people searched for a SUBLOCADE provider with the Find a SUBLOCADE Treatment Provider tool on the SUBLOCADE website in the first quarter.

    付費搜尋量仍高於活動前水準,且在核心搜尋關鍵字上維持類別領先的聲量占比。此外,第一季有超過 30,000 人透過 SUBLOCADE 官網上的「尋找 SUBLOCADE 治療提供者(Find a SUBLOCADE Treatment Provider)」工具搜尋 SUBLOCADE 醫療提供者。

  • To close, we are encouraged by our start to 2026. We believe that our improved commercial execution, focused on sharpened message delivery, with higher utilization of SUBLOCADE's core promotional materials on every call, along with our efforts directed at improving specialty pharmacy performance and consumer activation, are having impact on new patient starts, mix, and acceleration in SUBLOCADE dispense units.

    總結而言,我們對 2026 年的開局感到鼓舞。我們相信,我們改善後的商業執行(聚焦於更精準的訊息傳遞,並在每次拜訪中更高頻率使用 SUBLOCADE 的核心推廣素材),再加上我們致力於提升專科藥局表現與消費者啟動的努力,正對新病患起始、組合(mix)以及 SUBLOCADE 調劑單位數的加速成長產生影響。

  • We are confident that, as we continue to get better, SUBLOCADE will do better; and that we are on track to achieve our raised 2026 guidance for SUBLOCADE.

    我們有信心,隨著我們持續做得更好,SUBLOCADE 也會表現得更好;而且我們正按計畫達成我們上調後的 2026 年 SUBLOCADE 財測指引。

  • I will now turn the call over to Christian.

    接下來我將把電話會議交給 Christian。

  • Christian Heidbreder - Chief Scientific Officer

    Christian Heidbreder - Chief Scientific Officer

  • Thank you, Pat.

    謝謝你,Pat。

  • I will now provide an update on our R&D pipeline, starting with INDV-6001.

    接下來我將提供我們研發(R&D)產品線的最新進展,先從 INDV-6001 開始。

  • 6001 delivered meaningful scientific and regulatory progress during the year, achieving its principal Phase II objectives, including a supportive safety profile; predictable pharmacokinetics, consistent with modeling; and constructive engagement with the FDA.

    6001 在今年取得了具意義的科學與法規進展,達成其第二期(Phase II)主要目標,包括:具支持性的安全性概況;與模型一致、可預測的藥物動力學;以及與 FDA 的建設性互動。

  • As part of our portfolio review, we evaluated 6001 in the context of the evolving long-acting injectable buprenorphine landscape. In our review, SUBLOCADE is the only once-monthly long-acting injectable buprenorphine with a rapid initiation pathway in the approved label; continues to set the clinical and commercial standard in this category.

    作為我們產品組合檢視的一部分,我們在長效注射型丁丙諾啡(buprenorphine)市場格局持續演變的背景下評估了 6001。在我們的檢視中,SUBLOCADE 是唯一一款每月一次的長效注射型丁丙諾啡,且其核准標示中包含快速起始途徑;並持續在此類別中樹立臨床與商業標準。

  • SUBLOCADE's ability to achieve and maintain differentiated plasma concentrations without a complex induction regimen represents an important benchmark for future products.

    SUBLOCADE 能在不需要複雜誘導療程的情況下達成並維持差異化的血漿濃度,為未來產品提供了一項重要的標竿。

  • While INDV-6001 successfully demonstrated extended dosing intervals, including exploration of dosing up to three months, further analysis identified challenges.

    儘管 INDV-6001 成功證明可延長給藥間隔(包括探索最長可達三個月的給藥),進一步分析仍辨識出若干挑戰。

  • Specifically, achieving clinically meaningful plasma concentration profiles, particularly in a treatment environment shaped by high-potency synthetic opioids, was anticipated to require more complex induction protocol, relative to SUBLOCADE's established approach, introducing additional development and implementation considerations.

    具體而言,要達到具臨床意義的血漿濃度曲線,特別是在高效力合成類鴉片藥物所形塑的治療環境中,預期將需要相較於 SUBLOCADE 既有作法更為複雜的誘導方案,從而引入額外的開發與導入考量。

  • In addition, a comprehensive review of late-stage development and commercialization factors highlighted some remaining challenges, including, one, manufacturing scalability; and, two, limited anticipated clinical and commercial differentiation in the payer and prescriber landscape and the resulting impact on pricing and reimbursement dynamics.

    此外,對後期開發與商業化因素的全面檢視也凸顯了一些尚存挑戰,包括:(一)製造擴產能力;以及(二)在支付方與處方醫師環境中,預期臨床與商業差異化有限,及其對定價與給付(reimbursement)動態的影響。

  • As a result, we have decided not to advance INDV-6001 into Phase III clinical development and have amended our license agreement with Alar Pharmaceuticals.

    因此,我們已決定不將 INDV-6001 推進至第三期(Phase III)臨床開發,並已修訂我們與 Alar Pharmaceuticals 的授權協議。

  • Pursuant to these amendments, Alar will regain development rights to the asset and commercialization rights outside of the US. Indivior will maintain commercial rights in the US.

    依據這些修訂,Alar 將重新取得該資產的開發權,以及美國以外地區的商業化權利。Indivior 將保留美國的商業權利。

  • Turning to INDV-2000, in a Phase II proof-of-concept study, our selective orexin-1 receptor antagonist, under evaluation as a novel, non-opioid treatment for opioid use disorder, did not meet the pre-specified primary endpoint of no-treatment failure over 12 weeks, when evaluated across the full dose range: 100-, 200-, and 400-milligram versus placebo.

    接著談 INDV-2000。在一項第二期概念驗證(proof-of-concept)研究中,我們的選擇性食慾素-1(orexin-1)受體拮抗劑,作為一種新型、非鴉片類的鴉片使用障礙治療方案進行評估;在涵蓋完整劑量範圍(100、200、400 毫克)與安慰劑比較時,未達到預先設定的主要終點:12 週內無治療失敗(no-treatment failure)。

  • Interpretation of the overall dose response was confounded by unanticipated underperformance at the 400-milligram dose and a higher-than -anticipated placebo response.

    整體劑量反應的解讀受到干擾,原因在於 400 毫克劑量出現未預期的表現不佳,以及安慰劑反應高於預期。

  • While this Phase II study does not support advancing INDV-2000 internally in opioid use disorder, we are encouraged by the broader body of data that emerged from the trial.

    雖然這項第二期研究不支持我們在鴉片使用障礙領域內部推進 INDV-2000 的開發,但我們對試驗所產生的更廣泛數據仍感到鼓舞。

  • Importantly, prospectively planned sensitivity analysis, together with converging supportive findings, identified a credible and biologically coherent signal at the 200-milligram dose.

    重要的是,前瞻性規劃的敏感度分析(sensitivity analysis),連同趨同的支持性發現,辨識出在 200 毫克劑量下具有可信且在生物學上連貫的訊號。

  • At that dose, we observed higher abstinence rates, over time, versus placebo across cocaine; and broader polysubstance use, including cocaine, methamphetamine, amphetamine, benzodiazepine, and opioid, in combination.

    在該劑量下,相較於安慰劑,我們觀察到隨時間推移更高的戒斷(abstinence)比例,涵蓋可卡因;以及更廣泛的多重物質使用(polysubstance use),包括可卡因、甲基安非他命、安非他命、苯二氮平類與鴉片類的合併使用。

  • While these findings are exploratory, they are directionally consistent with the underlying orexin-1 mechanism and its potential role in cue-driven drug seeking, stress reactivity, and relapse vulnerability.

    雖然這些發現屬探索性,但其方向性與食慾素-1 的作用機制一致,並支持其在由線索驅動的尋藥行為、壓力反應性與復發脆弱性方面的潛在角色。

  • We also saw supportive directional improvements in anxiety symptoms, as well as exploratory functional MRI findings that aligned with the clinical observations and further supported the biological activity of INDV-2000.

    我們也看到焦慮症狀的支持性方向性改善,以及探索性的功能性 MRI 發現;這些結果與臨床觀察一致,並進一步支持 INDV-2000 的生物活性。

  • Taken together, these results strengthen our confidence that the molecule is engaging relevant relapse-related pathways.

    綜合而言,這些結果強化了我們對該分子正在作用於與復發相關之關鍵路徑的信心。

  • Importantly, INDV-2000 demonstrated a favorable safety and tolerability profile, with no major drug-related safety signal identified.

    同樣重要的是,INDV-2000 展現出良好的安全性與耐受性概況,未發現任何主要的藥物相關安全性訊號。

  • While we do not plan to pursue development internally in opioid use disorder, we believe these findings support continued evaluation of 200 milligrams as the lead dose and position INDV-2000 as a credible business development opportunity, while we continue to strengthen the data package through additional analysis, including exposure-response work; and further evaluation of supportive clinical and mechanistic findings.

    雖然我們不計畫在鴉片使用障礙領域內部推進開發,但我們相信這些發現支持持續評估 200 毫克作為主要劑量,並使 INDV-2000 成為可信的業務開發機會;同時我們將透過進一步分析(包括暴露量-反應(exposure-response)研究)以及對支持性臨床與機制性發現的進一步評估,持續強化數據資料包。

  • These decisions are expected to have a significant impact on the R&D organization. However, it does not reflect the quality of the underlying science or the team's execution.

    這些決策預期將對研發組織造成重大影響。然而,這並不反映基礎科學的品質或團隊的執行表現。

  • We are grateful for the rigor, dedication, and high-quality work of our R&D team, whose efforts advanced these programs; and generated valuable scientific and regulatory insights that will inform future innovation.

    我們感謝研發團隊的嚴謹、投入與高品質工作;他們的努力推進了這些計畫,並產生了寶貴的科學與法規洞見,將為未來創新提供參考。

  • I will now turn the call over to Ryan.

    接下來我將把電話會議交給 Ryan。

  • Ryan Preblick - Chief Financial Officer

    Ryan Preblick - Chief Financial Officer

  • Thanks, Christian.

    謝謝,Christian。

  • We are encouraged by our overall financial performance this quarter, which includes strong year-over-year total SUBLOCADE net revenue growth and even-stronger adjusted EBITDA growth.

    我們對本季整體財務表現感到鼓舞,其中包括 SUBLOCADE 淨營收強勁的年增成長,以及更為強勁的調整後 EBITDA 成長。

  • Looking at our results in more detail, starting with the top line, total net revenue of $317 million for the first quarter increased 19% versus the prior-year period. The increase was driven by strong SUBLOCADE net revenue growth in the US.

    更詳細來看我們的業績,先從營收端(top line)開始:第一季淨營收總額為 3.17 億美元,較去年同期增加 19%。此增幅主要由美國 SUBLOCADE 淨營收的強勁成長所帶動。

  • Total SUBLOCADE net revenue of $232 million for the quarter increased 32% versus the prior-year period. US SUBLOCADE net revenue increased 33% versus the prior year to $218 million.

    本季 SUBLOCADE 淨營收總額為 2.32 億美元,較去年同期增加 32%。美國 SUBLOCADE 淨營收較去年增加 33%,達 2.18 億美元。

  • Q1 net revenue growth was primarily driven by dispensed unit volume growth of 20% and favorable price mix. The first quarter included a gross-to-net benefit of $14 million.

    第一季淨營收成長主要由已配藥單位量成長 20% 以及有利的價格組合所帶動。第一季包含 1,400 萬美元的毛額轉淨額(gross-to-net)利益。

  • Turning to SUBOXONE Film net revenue, in the first quarter, we benefited from continued generic price stability in the US, moderated share decline, and favorable gross-to-net adjustments.

    接著談 SUBOXONE 薄膜(Film)淨營收,第一季我們受惠於美國持續的學名藥價格穩定、市占下滑趨緩,以及有利的毛額轉淨額調整。

  • As we said in February, we expect gross-to-net adjustments to serve as a headwind in 2026 for both SUBLOCADE and SUBOXONE.

    如同我們在 2 月所說,我們預期毛額轉淨額調整在 2026 年將對 SUBLOCADE 與 SUBOXONE 兩者形成逆風。

  • Total non-GAAP operating expenses were $116 million for the first quarter, down 21% versus the prior year. The decrease was primarily driven by reductions in headcount; the restructuring of the R&D and Medical Affairs organizations; and footprint consolidations as part of Phase I of the Indivior Action Agenda, Generate Momentum.

    第一季非 GAAP 營業費用總計 1.16 億美元,較去年同期下降 21%。下降主要來自人力縮減;研發與醫療事務組織重整;以及作為 Indivior 行動議程(Indivior Action Agenda)第一階段「Generate Momentum」的一部分所進行的據點整併。

  • Looking at the bottom line, we generated record adjusted EBITDA of $164 million, an increase of 112% year over year, representing margin improvement of 23 percentage points.

    從獲利面來看,我們創下調整後 EBITDA 1.64 億美元的歷史新高,年增 112%,代表利潤率改善 23 個百分點。

  • Our strong first-quarter results and performance trends year to date led us to raise our 2026 financial guidance.

    我們第一季強勁的業績與年初至今的表現趨勢,促使我們上調 2026 年財務指引。

  • We now expect total net revenue in the range of $1.215 billion to $1.285 billion, an increase of 1% compared to 2025 at the midpoint of our guidance range. This is primarily driven by stronger SUBLOCADE net revenue, which we now expect to be in the range of $950 million to $990 million, up 13% year over year at the midpoint.

    我們目前預期總淨營收介於 12.15 億至 12.85 億美元,在指引區間中點較 2025 年增加 1%。這主要由更強勁的 SUBLOCADE 淨營收所帶動;我們目前預期 SUBLOCADE 淨營收介於 9.50 億至 9.90 億美元,在中點年增 13%。

  • The increase in SUBLOCADE guidance reflects an improved outlook from an acceleration in dispense units, based on strong trends year to date and favorable mix related to our progress on increasing commercial dispense yields.

    SUBLOCADE 指引上調反映了更佳的展望,來自配藥單位數加速成長;此係基於年初至今的強勁趨勢,以及我們在提升商業配藥產出率(commercial dispense yields)方面取得進展所帶來的有利組合。

  • Our total net revenue guidance also reflects higher US SUBOXONE Film net revenue, based on year-to-date results, where we saw stable pricing and moderation in share decline.

    我們的總淨營收指引也反映美國 SUBOXONE 薄膜淨營收較高,係基於年初至今的結果:我們看到價格穩定且市占下滑趨緩。

  • Our outlook for operating expenses remains unchanged at $430 million to $450 million.

    我們對營業費用的展望維持不變,仍為 4.30 億至 4.50 億美元。

  • We now expect adjusted EBITDA for 2026 to be in the range of $620 million to $660 million, a year-over-year increase of 50% at the midpoint. This would represent an improvement of 16 percentage points in our adjusted EBITDA margin to 51% compared to 2025.

    我們目前預期 2026 年調整後 EBITDA 介於 6.20 億至 6.60 億美元,在中點年增 50%。這將使我們的調整後 EBITDA 利潤率較 2025 年提升 16 個百分點至 51%。

  • We ended the quarter with gross cash investments of $201 million. We are projecting forward leverage of 0.8 times, based on the midpoint of our 2026 adjusted EBITDA guidance.

    本季末我們的總現金投資為 2.01 億美元。以 2026 年調整後 EBITDA 指引中點為基礎,我們預估前瞻槓桿倍數為 0.8 倍。

  • In 2026, we expect to generate approximately $340 million in cash flow from operations, enabling us to strategically deploy capital.

    在 2026 年,我們預期將產生約 3.40 億美元的營運現金流,使我們得以策略性地配置資本。

  • Our capital deployment priorities include managing our debt; returning value to shareholders through opportunistic share repurchases; and evaluating business development opportunities, as we earn our way to Phase III of the Indivior Action Agenda, Breakout.

    我們的資本配置優先事項包括管理債務;透過機會性庫藏股回購為股東回饋價值;以及在我們邁向 Indivior 行動議程第三階段「Breakout」的過程中,評估業務開發機會。

  • In the first quarter, we managed our debt by completing an upsized $500 million senior convertible notes offering due in 2031. Most of the proceeds were used to repay the remaining $333 million balance on the previous term loan. This both increases our financial flexibility and significantly reduces our interest rate to 0.625% from 9.5%.

    第一季我們透過完成一筆規模上調至 5.00 億美元、2031 年到期的優先可轉換公司債發行來管理債務。大部分募集資金用於償還先前定期貸款剩餘的 3.33 億美元餘額。此舉同時提升我們的財務彈性,並將利率自 9.5% 大幅降至 0.625%。

  • We also returned capital to our shareholders through opportunistic share repurchases in the first quarter. We repurchased 4 million shares at an average price of $31.45 for a total of $125 million. We have $275 million remaining on the $400 million program through mid-2027.

    第一季我們也透過機會性股票回購向股東返還資本。我們以平均每股 31.45 美元回購 400 萬股,總額 1.25 億美元。4.00 億美元計畫截至 2027 年年中仍剩餘 2.75 億美元額度。

  • In total, over the past five years, we have bought back $525 million of our shares at an average price of $16.74.

    總計在過去五年中,我們以平均每股 16.74 美元回購了 5.25 億美元的自家股票。

  • As we earn our way to Phase III, Breakout, we will evaluate business development opportunities, specifically focused on commercial-stage assets that have the potential to enhance and diversify our growth profile.

    在我們邁向第三階段「Breakout」的過程中,我們將評估業務開發機會,特別聚焦於商業化階段資產,這些資產有潛力強化並多元化我們的成長輪廓。

  • I'll now turn the call back to Joe for concluding remarks.

    接下來我把電話交回給 Joe 做結語。

  • Joseph Ciaffoni - Chief Executive Officer, Director

    Joseph Ciaffoni - Chief Executive Officer, Director

  • Thanks, Ryan.

    謝謝你,Ryan。

  • The first quarter reflects our significant progress against Phase II of the Indivior Action Agenda, Accelerate.

    第一季反映我們在 Indivior 行動議程第二階段「Accelerate」上取得的重大進展。

  • We delivered strong top- and bottom-line growth, driven by SUBLOCADE's performance in the US and leverage from our simplified operating model, enabling us to meaningfully raise our 2026 financial guidance.

    我們在營收與獲利端都實現強勁成長,主要由 SUBLOCADE 在美國的表現,以及我們簡化營運模式所帶來的槓桿效益所驅動,使我們得以大幅上調 2026 年財務指引。

  • We also executed on our capital-deployment strategy by successfully managing our debt and opportunistically utilizing our share repurchase program.

    我們也透過成功管理債務並機會性運用股票回購計畫,落實資本配置策略。

  • We are on track to accelerate SUBLOCADE throughout 2026; and adjusted EBITDA and cash flow at an even faster rate, as we earn our way to Phase III of the Indivior Action Agenda, Breakout, in the second half of 2026.

    我們正按計畫在 2026 年加速推進 SUBLOCADE;而調整後 EBITDA 與現金流的成長速度將更快,因為我們將在 2026 年下半年邁向 Indivior 行動議程第三階段「Breakout」。

  • We will now open the call for questions. Operator?

    我們現在開放提問。接線員?

  • Operator

    Operator

  • Thank you so much.

    非常感謝。

  • (Operator Instructions)

    (接線員指示)

  • David Amsellem, Piper Sandler.

    David Amsellem,Piper Sandler。

  • David Amsellem - Senior Research Analyst

    David Amsellem - Senior Research Analyst

  • Thanks. I have a few.

    謝謝。我有幾個問題。

  • First, on the gross margins, there's some improvement here. With the manufacturing transition, should we take that to mean that you could see manufacturing at even better gross margins, going forward? Help us just understand how to think about gross margins, going forward. That's number 1.

    首先,關於毛利率,這裡有一些改善。隨著製造轉換,我們是否可以理解為未來製造端的毛利率還可能更好?請協助我們理解未來該如何看待毛利率。這是第一點。

  • Number 2, business development and M&A. I know, Joe, you've talked about a beachhead in another therapeutic category. I was wondering if you could elaborate on that and what therapeutic categories, broadly speaking, are of interest?

    第二點,業務開發與併購(M&A)。Joe,我知道你談過在另一個治療領域建立灘頭堡。我想請你進一步說明,以及廣義而言,哪些治療領域是你們感興趣的?

  • And then, lastly, on the accelerated second dosing, can you talk about how getting patients to receive that accelerated second dose is correlated with this overall persistence; and how important that is? If you had color on that earlier in your prepared remarks, sorry, I missed that. Love to get your thoughts on how that accelerated second dose plays a role in patient persistence.

    最後,關於加速第二劑給藥,你能否談談讓病人接受加速第二劑與整體治療持續性(persistence)之間的關聯,以及其重要性?如果你在事先準備的發言中已提到相關內容,抱歉我漏聽了。很想聽聽你對加速第二劑在病人持續性中扮演角色的看法。

  • Thanks.

    謝謝。

  • Joseph Ciaffoni - Chief Executive Officer, Director

    Joseph Ciaffoni - Chief Executive Officer, Director

  • Okay. Thanks, David. We'll let Ryan kick it off with the gross margins.

    好的。謝謝你,David。我們先請 Ryan 針對毛利率開場。

  • Ryan Preblick - Chief Financial Officer

    Ryan Preblick - Chief Financial Officer

  • Hey, David. Good morning. Thanks for the question.

    嗨,David。早安。謝謝你的問題。

  • For the gross margins, I would still guide you to the full mid-80% guide. Q1 did benefit from a couple of things:

    關於毛利率,我仍會建議你以全年約 80% 中段(mid-80%)的指引為準。第一季確實受惠於幾個因素:

  • One, we had the prior-year releases. Two, we had positive manufacturing variances built in there, as well.

    第一,我們有前一年度的釋出項目。第二,我們也納入了正向的製造差異(manufacturing variances)。

  • And then, in regards to the plan, the primary focus on the manufacturing facility is to secure product security. Again, I would guide you to the mid-80%s for margins for the year.

    另外,就計畫而言,製造設施的主要重點是確保產品供應安全。再次強調,我會建議你以全年利潤率約 80% 中段為準。

  • Joseph Ciaffoni - Chief Executive Officer, Director

    Joseph Ciaffoni - Chief Executive Officer, Director

  • Okay. Pat, on the accelerated second dose?

    好的。Pat,關於加速第二劑?

  • Patrick Barry - Chief Commercial Officer

    Patrick Barry - Chief Commercial Officer

  • Yeah. Thank you for the question, David.

    好的。謝謝你的問題,David。

  • On the accelerated second dose, that's an important differentiator for us because with, the only LAI with that accelerated second dose, the benefit there is that you're achieving peak plasma levels early; as early as day 8.

    關於加速第二劑,這對我們而言是一個重要的差異化因素,因為我們是唯一具有加速第二劑的長效注射劑型(LAI)。其好處在於你能更早達到血漿峰值濃度;最早可在第 8 天。

  • And so that's an important component to be able to get the patient doing well in the very early of treatment. Peak plasma levels is particularly important in the era of synthetic opioids.

    因此,這是讓病人在治療非常早期就能有良好狀態的一個重要組成。血漿峰值濃度在合成類鴉片(synthetic opioids)的時代尤其重要。

  • And so, if they're doing better early and they're stabilized early, we believe that, over time, that could help with persistency. But that's certainly something we'll continue to look at.

    因此,如果他們在早期表現更好、也更早穩定下來,我們相信長期而言可能有助於治療持續性。不過這確實是我們會持續觀察的事項。

  • Joseph Ciaffoni - Chief Executive Officer, Director

    Joseph Ciaffoni - Chief Executive Officer, Director

  • Okay. And then, from a BD perspective, David, as we earn our way to the Breakout phase, which we believe we're on track to do in the second half of this year, we're, I would say, therapeutically agnostic, although there are certainly areas we don't think we would go into, for example, like oncology.

    好的。然後,從業務開發(BD)的角度來看,David,隨著我們邁向 Breakout 階段——我們相信我們有望在今年下半年達成——我會說我們在治療領域上並不預設特定方向(therapeutically agnostic),不過確實有一些領域我們認為不會進入,例如腫瘤科。

  • We're more focused on the fundamentals of what we would acquire. We are focused commercial-stage, only. We're looking for assets that have greater than $200 million peak sales potential. We think that's relevant, relative to the size of our revenue base, as we seek to enhance and diversify our growth profile.

    我們更專注於我們將收購標的的基本面。我們只聚焦於商業化階段。我們在尋找峰值銷售潛力超過2億美元的資產。我們認為,考量到我們的營收基礎規模,這一點很重要,因為我們希望強化並多元化我們的成長輪廓。

  • Differentiated assets are important, from our perspective, both from a patient-value perspective and, importantly, from a reimbursement perspective, which we think is critical to commercial success.

    從我們的角度來看,具差異化的資產很重要,這不僅關乎病患價值,更重要的是關乎給付/報銷(reimbursement)的角度;我們認為這對商業成功至關重要。

  • And then, the final thing I would highlight because I think it's one of the real strong parts of the Indivior story is that, with SUBLOCADE, we have a durable growth driver. And so the third thing that will be important in anything we acquire is that those assets also have runway.

    最後一點我想強調的是,我認為這也是 Indivior 故事中非常強的一部分:透過 SUBLOCADE,我們擁有一個具持久性的成長驅動力。因此,我們在任何收購中看重的第三件事是:那些資產也必須有足夠的成長跑道。

  • From there, post-integration of an acquisition, we then would be looking to identify individual products that could leverage the new commercial infrastructure that we have in place.

    在那之後,於收購完成整合後,我們會尋找可利用我們既有新商業基礎設施的個別產品。

  • David Amsellem - Senior Research Analyst

    David Amsellem - Senior Research Analyst

  • Okay. Helpful. Thanks.

    好的。很有幫助。謝謝。

  • Joseph Ciaffoni - Chief Executive Officer, Director

    Joseph Ciaffoni - Chief Executive Officer, Director

  • All right. Thank you, David.

    好。謝謝你,David。

  • Operator

    Operator

  • Chase Knickerbocker, Craig-Hallum.

    Chase Knickerbocker,Craig-Hallum。

  • Chase Knickerbocker - Analyst

    Chase Knickerbocker - Analyst

  • Good morning. Thanks for taking the questions. Congrats on another nice quarter here.

    早安。謝謝讓我提問。恭喜本季又交出不錯的成績。

  • Maybe just, first, for Ryan: There's been some continued gross-to-net benefit on a year-over-year basis. Maybe just focusing on SUBLOCADE, can you just give us a sense for how you characterize that gross-to-net benefit a little bit more; and then, give us a sense for how you expect it to roll off through the year?

    也許先問 Ryan:按年比較,毛到淨(gross-to-net)仍有一些持續性的利多。聚焦在 SUBLOCADE 上,你能否更具體說明你們如何描述這個毛到淨的利多;以及你們預期它在今年會如何逐步消退?

  • Thanks.

    謝謝。

  • Ryan Preblick - Chief Financial Officer

    Ryan Preblick - Chief Financial Officer

  • Yeah. Chase, good morning. Thanks for the question.

    好的。Chase,早安。謝謝你的問題。

  • Yes. In Q1, we did book $14 million of a prior-year release, as we continue to true up our accruals. But, as we mentioned earlier, in totality, we still expect the prior-year releases to serve as a headwind for the balance of 2026.

    是的。在第一季,我們認列了1,400萬美元的前一年度回沖(release),因為我們持續校準(true up)我們的應計項目。不過,如同我們先前提到的,整體而言,我們仍預期前一年度回沖在2026年剩餘期間將成為逆風。

  • The plan is to continue to provide you an update each quarter.

    我們的計畫是每一季都會向各位提供更新。

  • Chase Knickerbocker - Analyst

    Chase Knickerbocker - Analyst

  • Could you just maybe give us a sense for the cadence of that headwind through the year; and if there's any benefit you expect in Q2, as well?

    你能否大概說明一下,這個逆風在今年的節奏/分布會是如何;以及你們是否也預期第二季會有任何利多?

  • And then, just second from me, guys; maybe just taking a step back, for Joe: If you look at 6001 here -- again, maybe just taking a step back, with the potential for BRIXADI generics before SUBLOCADE [LOE], how do you see this market developing?

    另外第二個問題,想請教 Joe:回到 6001——再退一步看,若在 SUBLOCADE 專利到期([LOE])之前,BRIXADI 的學名藥可能先出現,你怎麼看這個市場會如何發展?

  • How are you thinking about franchise expansion and life-cycle management, as you think about your long-acting buprenorphine franchise; and just how you see the market developing, Joe?

    你如何思考你們長效丁丙諾啡(buprenorphine)產品線的特許經營擴張與產品生命週期管理;以及你對市場演進的看法,Joe?

  • Joseph Ciaffoni - Chief Executive Officer, Director

    Joseph Ciaffoni - Chief Executive Officer, Director

  • Sure. Ryan?

    好的。Ryan?

  • Ryan Preblick - Chief Financial Officer

    Ryan Preblick - Chief Financial Officer

  • Chase. Yeah. At this point, there will be adjustments for the balance of the year. I don't know the phasing at this point. But I will continue to tell you, in the aggregate, the prior-year releases will serve as a headwind in 2026.

    Chase,是的。就目前而言,今年剩餘期間會有調整。我現在還不清楚其時間分布(phasing)。但我會持續告訴你,整體來看,前一年度回沖在2026年將構成逆風。

  • Chase Knickerbocker - Analyst

    Chase Knickerbocker - Analyst

  • Sure.

    了解。

  • Joseph Ciaffoni - Chief Executive Officer, Director

    Joseph Ciaffoni - Chief Executive Officer, Director

  • Chase, with regards to your question around the evolution of the marketplace, look, we're very confident in SUBLOCADE's differentiated profile.

    Chase,關於你問到市場演進的問題,坦白說,我們對 SUBLOCADE 的差異化特徵非常有信心。

  • Importantly, when you look at SUBLOCADE, the 300-milligram dose continues to grow. It's now 63% of overall SUBLOCADE utilization.

    重要的是,當你看 SUBLOCADE 時,300毫克劑量持續成長;目前已占 SUBLOCADE 整體使用量的63%。

  • We're very confident that SUBLOCADE has a durable growth profile. It's an asset that we're committed to for the long term.

    我們非常有信心 SUBLOCADE 具備持久的成長輪廓。這是一項我們承諾長期投入的資產。

  • As it pertains to further opportunity within the space, we're obviously always looking and are aware of what's out there. There's nothing, candidly, that we're interested in that we don't have.

    至於在此領域的進一步機會,我們當然一直在觀察,也了解外部有哪些動向。坦白說,沒有任何我們感興趣、但我們目前尚未擁有的東西。

  • To the degree that Alar is successful in the development and manufacturing of 6001 to a level that meets what we believe would make it commercially viable, we retain 100% of the commercial rights to that asset in the US.

    如果 Alar 在 6001 的開發與製造上能成功達到我們認為具商業可行性的水準,我們仍保有該資產在美國100%的商業權利。

  • We certainly wish them well in their pursuit.

    我們當然祝福他們的推進一切順利。

  • Chase Knickerbocker - Analyst

    Chase Knickerbocker - Analyst

  • Understood. Thank you.

    了解。謝謝。

  • Joseph Ciaffoni - Chief Executive Officer, Director

    Joseph Ciaffoni - Chief Executive Officer, Director

  • You got it.

    不客氣。

  • Operator

    Operator

  • Dennis Ding, Jefferies.

    Dennis Ding,Jefferies。

  • Dennis Ding - Analyst

    Dennis Ding - Analyst

  • Hi. Good morning. Thanks for taking our questions. Congrats on a very good quarter.

    嗨,早安。謝謝回答我們的問題。恭喜這是一個非常好的季度。

  • Joseph Ciaffoni - Chief Executive Officer, Director

    Joseph Ciaffoni - Chief Executive Officer, Director

  • Thank you.

    謝謝。

  • Dennis Ding - Analyst

    Dennis Ding - Analyst

  • If I can ask on Lilly's brenipatide, they sound fairly excited about it and its potential in substance use disorders. They started Phase 2 in OUD on a background of buprenorphine, which I'm assuming is SUBOXONE.

    我想問一下禮來(Lilly)的 brenipatide,他們聽起來對它以及其在物質使用障礙(substance use disorders)上的潛力相當興奮。他們已在 OUD 的第二期試驗中啟動,並以丁丙諾啡作為背景治療(background),我猜應該是 SUBOXONE。

  • I'm curious how you're thinking about the design of that study; the read-out in 2028; and, importantly, if that impacts durability of SUBLOCADE growth through the long term, which I'm assuming goes off patent in the 2035 to 2038 timeframe.

    我想了解你們如何看待該研究的設計、2028年的讀出(read-out);以及更重要的是,這是否會影響 SUBLOCADE 長期成長的持久性——我猜 SUBLOCADE 的專利大概在2035到2038年期間到期。

  • Thank you.

    謝謝。

  • Joseph Ciaffoni - Chief Executive Officer, Director

    Joseph Ciaffoni - Chief Executive Officer, Director

  • Okay. Dennis, before I hand it off to Christian to comment, the one thing I want to emphasize is we very strongly believe that SUBLOCADE has a long and durable runway in front of it, with 12 Orange Book-listed patents that go from 2031 to 2038.

    好的。Dennis,在我把問題交給 Christian 補充之前,我想強調一點:我們非常堅信 SUBLOCADE 前方仍有很長且持久的成長跑道;目前在《橘皮書》(Orange Book)中列有12項專利,期限從2031年到2038年。

  • We also are in the process of trying to pull through additional patent applications that have the potential to extend out to 2044 to 2046.

    我們也正在推進其他專利申請,這些申請有機會將保護期延伸到2044到2046年。

  • Christian, on any comments on?

    Christian,有沒有什麼補充評論?

  • Christian Heidbreder - Chief Scientific Officer

    Christian Heidbreder - Chief Scientific Officer

  • Yes. Certainly. There are several trials that are currently ongoing; using GLP-1 for substance use disorder. The one that you mentioned in opioid use disorder, this is actually as an add-on therapy to transmucosal buprenorphine. There are a couple of other trials in alcohol use disorder.

    是的,當然。目前有數個試驗正在進行,使用 GLP-1 來治療物質使用障礙。你提到的那個鴉片類使用障礙試驗,實際上是作為經黏膜(transmucosal)丁丙諾啡的加成治療(add-on therapy)。另外還有幾個試驗是在酒精使用障礙。

  • I must say that, so far, the evidence has been primarily anecdotal. It's the first time that there will be more formal clinical trials. We shall see what the outcome is.

    我必須說,到目前為止,相關證據主要仍是零星的個案觀察(anecdotal)。這將是第一次有更正式的臨床試驗。我們將看看結果如何。

  • Please do remember that these trials, so far, for opioid use disorder have been designed as add-on therapy to buprenorphine.

    也請記得,到目前為止,這些針對鴉片類使用障礙的試驗設計,都是作為丁丙諾啡的加成治療。

  • Dennis Ding - Analyst

    Dennis Ding - Analyst

  • Perfect. Thanks. If I can ask a follow-up on DTC?

    很好,謝謝。我可以追問一個關於 DTC(直接面向消費者)的問題嗎?

  • The campaign is obviously trying to increase category growth, which we're seeing in the numbers. But I'm also surprised that SUBLOCADE share continues to be generally stable.

    這個活動顯然是想帶動品類成長,我們也在數據中看到了。但我也很意外 SUBLOCADE 的市占仍大致維持穩定。

  • My question is: Do you expect to pick up incremental share this year, as DTC continues? Isa there any leading indicators that you can disclose around initial share capture?

    我的問題是:隨著 DTC 持續進行,你們預期今年會取得額外的市占嗎?是否有任何你們可以揭露的領先指標,能反映初期的市占取得情況?

  • Thanks.

    謝謝。

  • Joseph Ciaffoni - Chief Executive Officer, Director

    Joseph Ciaffoni - Chief Executive Officer, Director

  • Yeah. Dennis, I'll take that one. I appreciate the question.

    好的,Dennis,這題我來回答。謝謝你的提問。

  • As we've been clear, our focus is on net revenue, new patient starts, and driving long-acting injectable market growth.

    如同我們一直說得很清楚的,我們的重點在於淨營收、新病患起始治療(new patient starts),以及推動長效注射劑市場的成長。

  • We're very proud of the fact that share is stable at 76%. Whether it goes up a little bit, down a little bit, in terms of the overall performance of SUBLOCADE, both in this year and as we go forward, in our view, it's really not material. It's more about just the competitiveness within the space.

    我們對市占穩定在76%感到非常自豪。至於它是小幅上升或小幅下降,就 SUBLOCADE 的整體表現而言,不論是今年或未來,在我們看來都不是關鍵;更重要的是該領域內的競爭態勢。

  • We're very confident in our commercial team. We're very confident in the differentiated profile that SUBLOCADE brings to the market as the first and number 1 prescribed long-acting injectable.

    我們對我們的商業團隊非常有信心。我們也非常有信心 SUBLOCADE 作為第一個、且處方量排名第1的長效注射劑,所帶來的差異化市場定位。

  • Dennis Ding - Analyst

    Dennis Ding - Analyst

  • Perfect. Thanks so much.

    很好,非常感謝。

  • Joseph Ciaffoni - Chief Executive Officer, Director

    Joseph Ciaffoni - Chief Executive Officer, Director

  • You got it.

    不客氣。

  • Operator

    Operator

  • Christian Glennie, Stifel.

    Christian Glennie,Stifel。

  • Christian Glennie - Analyst

    Christian Glennie - Analyst

  • Yeah. Thanks, guys. Thanks for taking the questions.

    是的,謝謝各位。謝謝讓我提問。

  • Just starting on the outlook for SUBLOCADE: Particularly, on the dispense growth, you did 20% in the first quarter. But the guidance for the full year seems to be still around the mid-teens level.

    先從 SUBLOCADE 的展望談起:特別是發藥量(dispense)成長方面,你們第一季做到了20%。但全年指引看起來仍大約在十幾%的中段水準。

  • Just trying to, yeah, understand, initially, around that. Is it just a prudence thing? Is there some reason why that dispense growth might imply a slowdown through the rest of the year?

    我想先理解一下這點。這只是出於審慎嗎?還是有什麼原因使得發藥量成長在今年剩餘期間可能放緩?

  • That's my first question. Thanks.

    那是我的第一個問題。謝謝。

  • Joseph Ciaffoni - Chief Executive Officer, Director

    Joseph Ciaffoni - Chief Executive Officer, Director

  • Yeah. Christian, thanks for the question.

    是的。Christian,謝謝你的提問。

  • Remember, in the first quarter of 2025, that serves as a really low bar. from a comparable perspective. What we're confident in is, on a full-year basis, that we're going to be able to achieve mid-teen dispense unit growth, which is double what it is that we achieved in 2025.

    請記得,2025 年第一季作為比較基期非常低。就可比角度而言,我們有信心在全年基礎上,能夠達成中十位數(mid-teen)的發藥單位(dispense unit)成長,這是我們在 2025 年所達成的兩倍。

  • Importantly, what I would focus you to, is the 13% increase in revenue, which is driven by the strong dispense unit growth but also, now the favorable outlook that we have in terms of mix. What I mean by that is the percent that commercial will account for versus what we planned.

    重要的是,我希望你關注的是營收成長 13%,這是由強勁的發藥單位成長所帶動,同時也反映我們在產品組合(mix)方面更有利的展望。我的意思是,商業保險(commercial)占比相較於我們原先規劃的占比。

  • Realize, even incremental movement on a brand of this size, 1 point improvement of commercial mix, relative to what we had planned, is worth about $8 million.

    要知道,即使對於這種規模的品牌,任何增量變動都很有意義;商業組合相較於我們原先規劃每提升 1 個百分點,約等於增加 800 萬美元的價值。

  • That's certainly a key driver of the positive outlook that we have, moving forward. We've put a lot of effort, which is a real tribute to [Pat] and his team; Susan Neff, who heads up trade and our work with specialty pharmacy; and trying to improve the dispense yield, in particular with the [SPs] that skew to commercial.

    這無疑是我們對未來持正向展望的一個關鍵驅動因素。我們投入了大量努力,這也要歸功於[Pat]及其團隊;負責通路(trade)以及我們與專科藥局合作的 Susan Neff;並且致力於提升發藥轉化率(dispense yield),特別是針對那些商業保險占比較高的[SPs](專科藥局)。

  • Christian Glennie - Analyst

    Christian Glennie - Analyst

  • Thanks That's helpful.

    謝謝,這很有幫助。

  • Second would be just any comment around the overall growth in LAI category, overall; and the share of LAI as a percentage of the overall buprenorphine market?

    第二個問題是,能否評論一下整體 LAI 類別的總體成長,以及 LAI 在整體丁丙諾啡(buprenorphine)市場中所占的比例?

  • Thanks.

    謝謝。

  • Joseph Ciaffoni - Chief Executive Officer, Director

    Joseph Ciaffoni - Chief Executive Officer, Director

  • Yeah. Pat?

    好的。Pat?

  • Patrick Barry - Chief Commercial Officer

    Patrick Barry - Chief Commercial Officer

  • Yeah Thanks for the question.

    好的,謝謝你的提問。

  • We saw a really nice growth: approaching 23% on LAI category. We feel like our efforts, from a direct-to-consumer perspective, are fueling that.

    我們看到 LAI 類別有非常不錯的成長:接近 23%。我們認為,我們從直接面向消費者(direct-to-consumer)的角度所做的努力正在推動這個成長。

  • Again, we continue to maintain that category share dominance at plus 76%.

    同樣地,我們仍維持在該類別中超過 76% 的領先市占。

  • Joseph Ciaffoni - Chief Executive Officer, Director

    Joseph Ciaffoni - Chief Executive Officer, Director

  • Yeah. Christian, the only thing that I would add -- I think it's another interesting thing that gets to the impact that we believe the consumer campaign is having:

    是的。Christian,我唯一想補充的是——我認為這也是另一個有趣的點,能反映我們相信消費者行銷活動正在產生的影響:

  • In the first quarter, the oral buprenorphine market grew significantly, relative to the rate it had consistently been growing. The reason that's important is the start point of long-acting injectable patients are predominantly people that transition from a transmucosal buprenorphine.

    在第一季,口服丁丙諾啡市場的成長顯著加速,相較於過去一段時間一貫的成長速度。這之所以重要,是因為長效注射劑患者的起點,多數是從經黏膜(transmucosal)丁丙諾啡轉換而來。

  • From a big picture, as a company that has a long-term commitment to this space that, first and foremost, is focused on patients getting treatment to improve the outcome in their recovery journey, we're very encouraged by that.

    從更宏觀的角度來看,作為一家長期承諾深耕此領域的公司,我們首先且最重要的目標,是讓患者獲得治療,以改善其復原旅程中的治療結果;因此我們對此感到非常鼓舞。

  • That, also, is a positive, over time, in our view, to long-acting injectable utilization.

    而且,隨著時間推移,在我們看來,這也將對長效注射劑的使用量帶來正面影響。

  • Christian Glennie - Analyst

    Christian Glennie - Analyst

  • Thanks. Sorry. Just follow on the percentage -- the rough percentage share of LAIs, overall, as a percentage of orals?

    謝謝。抱歉,再追問一下比例——LAI 相對於口服劑型的整體占比大約是多少?

  • Patrick Barry - Chief Commercial Officer

    Patrick Barry - Chief Commercial Officer

  • Yeah. We're right at about 8.5%, from an overall LAI category-share perspective.

    是的。從整體 LAI 類別占比的角度來看,我們目前大約在 8.5% 左右。

  • Sorry. I missed out on that.

    抱歉,我剛剛漏聽了那個數字。

  • Christian Glennie - Analyst

    Christian Glennie - Analyst

  • Okay. Thank you. Thanks. No worries. Sorry. Finally, just on guidance on OpEx: You're unchanged there. But, at the same time, not progressing the Phase II -- two Phase II assets. I think, previously, you had implied that the guidance assumed those would roll on.

    好的。謝謝。謝謝。不客氣。抱歉。最後一個問題,關於營運費用(OpEx)的指引:你們那部分維持不變。但同時,你們也不再推進兩個第二期(Phase II)資產。我記得先前你們曾暗示指引是假設那些會繼續推進。

  • Just trying to understand, on OpEx and whether there's something I'm missing there, why potentially the OpEx wouldn't be a bit lower, given you implied a bit of restructuring of R&D and the impact that that would have.

    我想了解的是,在 OpEx 上是否有我漏掉的地方;既然你們提到研發(R&D)會有一些重整,以及其帶來的影響,為什麼 OpEx 可能不會更低一些?

  • Thanks.

    謝謝。

  • Joseph Ciaffoni - Chief Executive Officer, Director

    Joseph Ciaffoni - Chief Executive Officer, Director

  • Yeah. I'll take that one. I appreciate the question.

    好的。這題我來回答。謝謝你的提問。

  • Look, we're focused and have been clear on making every possible investment to maximize the SUBLOCADE opportunity in the US market.

    你看,我們的重點是——而且我們也一直很清楚——要做出一切可能的投資,以在美國市場最大化 SUBLOCADE 的機會。

  • The way to think of our guidance in 2026 is, as we derive savings from the restructuring in R&D and as we continue to relentlessly focus on making sure we're only investing in things that are essential, if there are opportunities for us to invest in SUBLOCADE that would have impact this year or in 2027, we would make those investments and come in at the high end of the guidance range.

    對於 2026 年的指引,你可以這樣理解:當我們從研發重整中取得節省、並持續嚴格聚焦確保只投資於必要事項時,如果出現能夠投資於 SUBLOCADE、且會在今年或 2027 年產生影響的機會,我們就會進行那些投資,並使費用落在指引區間的高端。

  • To the degree that there aren't areas for us to invest those resources, we would let them drop to the bottom line.

    若沒有適合投入這些資源的領域,我們就會讓這些節省直接反映到最終獲利(bottom line)。

  • The other point I want to emphasize is, as you think about the exciting phase we're in of the acceleration of SUBLOCADE, we're also leveraging, not growing, our cost structure on a going-forward basis.

    我還想強調另一點:當你思考 SUBLOCADE 正在加速的這個令人振奮階段時,我們同時也在槓桿運用(leveraging)而非擴張我們未來的成本結構。

  • When you think about it moving forward, you should expect to see us staying under that $450 million level, which will result in additional margin improvement.

    展望未來,你應該會看到我們維持在 4.5 億美元以下,這將帶來額外的利潤率改善。

  • Christian Glennie - Analyst

    Christian Glennie - Analyst

  • That's great. Thanks, guys.

    太好了。謝謝各位。

  • Joseph Ciaffoni - Chief Executive Officer, Director

    Joseph Ciaffoni - Chief Executive Officer, Director

  • You got it.

    沒問題。

  • Operator

    Operator

  • Brandon Folkes, HC Wainwright.

    Brandon Folkes,HC Wainwright。

  • Brandon Folkes - Equity Analyst

    Brandon Folkes - Equity Analyst

  • Hi. Thanks for taking my questions. Congrats on the quarter.

    嗨,謝謝讓我提問。恭喜本季表現。

  • Joseph Ciaffoni - Chief Executive Officer, Director

    Joseph Ciaffoni - Chief Executive Officer, Director

  • Thank you.

    謝謝。

  • Brandon Folkes - Equity Analyst

    Brandon Folkes - Equity Analyst

  • Maybe just following up on business development: Can you just talk about the size of the transaction you would consider? Hearing your criteria earlier around minimum peak sales, that sets one end of the range.

    我想追問一下業務發展(business development):你們會考慮多大規模的交易?先前你們提到最低峰值銷售額(minimum peak sales)的標準,這界定了區間的一端。

  • But just trying to think about how large of a transaction you feel comfortable with. Can you just talk about where you feel comfortable taking leverage up to?

    但我想了解你們對於多大規模的交易會覺得比較舒適。你們能談談你們覺得可以把槓桿(leverage)提高到什麼程度嗎?

  • And then, along the same lines, you talked about a commercial asset. But would you also consider a commercial-ready asset or company, which also has a pipeline? Can you just talk about your willingness to bring in or minimize development risk, altogether, here in business development?

    另外,同樣的脈絡下,你們提到商業化資產(commercial asset)。但你們是否也會考慮已具備商業化準備(commercial-ready)的資產或公司,同時也擁有產品線(pipeline)?能否談談在業務發展上,你們對於引入或盡量降低開發風險(development risk)的意願?

  • Thank you.

    謝謝。

  • Joseph Ciaffoni - Chief Executive Officer, Director

    Joseph Ciaffoni - Chief Executive Officer, Director

  • Thanks, Brandon.

    謝謝你,Brandon。

  • I'll let Ryan take the first question. I'll take the second.

    第一個問題我請 Ryan 回答。第二個我來回答。

  • Ryan Preblick - Chief Financial Officer

    Ryan Preblick - Chief Financial Officer

  • Yeah. Thanks for the question.

    好的,謝謝你的提問。

  • When it comes to the amount of leverage that we would feel comfortable with, with our strong balance sheet, we would be okay going up to 3 times. But that is assuming that we are going after a commercial-stage asset.

    就我們覺得舒適的槓桿水準而言,憑藉我們強勁的資產負債表,我們可以接受提高到 3 倍。但前提是假設我們鎖定的是商業化階段(commercial-stage)的資產。

  • Joseph Ciaffoni - Chief Executive Officer, Director

    Joseph Ciaffoni - Chief Executive Officer, Director

  • Okay. And then, Brandon, when you think about our focus from an M&A perspective, we're clearly focused on commercial stage. We want to enhance and diversify the growth profile of the company.

    好的。然後,Brandon,從併購(M&A)的角度來看,我們的重點很明確是商業化階段。我們希望強化並分散公司的成長輪廓。

  • We are not anti-pipeline. In fact, we believe the financial strength of the company would enable us -- if we acquire a company that has pipeline that we believe is worth investing in, we would be positioned to do so.

    我們並不排斥產品線(pipeline)。事實上,我們相信公司的財務實力能讓我們——如果我們收購一家擁有我們認為值得投資之產品線的公司——具備投入的條件。

  • But that is not the primary focus, as we're assessing opportunities -- and then, when we ultimately get to Phase III, Breakout, and start to try to action around them.

    但這不是主要焦點,當我們在評估機會時——以及當我們最終進入第三期(Phase III)、Breakout,並開始嘗試推動落地執行(action)時。

  • Brandon Folkes - Equity Analyst

    Brandon Folkes - Equity Analyst

  • Great. Thanks very much. Congrats, again, on the quarter.

    非常好。非常感謝。再次恭喜本季表現。

  • Joseph Ciaffoni - Chief Executive Officer, Director

    Joseph Ciaffoni - Chief Executive Officer, Director

  • You got it. Thank you.

    沒問題。謝謝。

  • Operator

    Operator

  • Thank you. Dear speakers, there are no further questions for today.

    謝謝。各位講者,今天已沒有其他提問。

  • I would now like to hand the conference over to your speaker, Joe Ciaffoni, for any closing remarks.

    現在我想把會議交回給你們的講者 Joe Ciaffoni,請他做結語。

  • Joseph Ciaffoni - Chief Executive Officer, Director

    Joseph Ciaffoni - Chief Executive Officer, Director

  • Thank you, operator.

    謝謝,接線員。

  • Thank you to everyone for joining the call today. We look forward to updating you on our progress, as we execute the Indivior Action Agenda.

    謝謝大家今天參與電話會議。我們期待在執行 Indivior 行動議程(Indivior Action Agenda)的過程中,向各位更新我們的進展。

  • Have a great day.

    祝大家有美好的一天。

  • Operator

    Operator

  • This concludes today's conference call. Thank you for participating.

    今天的電話會議到此結束。感謝各位參與。

  • You may now all disconnect. Have a nice day.

    各位現在可以斷線。祝大家有美好的一天。