Indivior PLC (INDV) 2024 Q1 法說會逐字稿

Good morning, everyone. 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 on slide 2 of this presentation. We also may refer to non-GAAP measures, the reconciliations, for which may also be found in the appendix to our presentation that has now posted on our website at indivior.com.

大家，早安。在開始之前，我需要提醒大家，在今天的電話會議上，我們可能會做出前瞻性陳述，這些陳述存在風險和不確定性，實際結果可能會有重大差異。我們在本簡報的投影片 2 中列出了可能導致我們的結果出現重大差異的因素。我們也可能會參考非 GAAP 衡量標準（即調節表），這些資訊也可以在我們的簡報的附錄中找到，該簡報現已發佈在我們的網站 indivior.com 上。

I'll now turn the call over to Mark Crossley, our CEO.

現在我將把電話轉給我們的執行長馬克‧克羅斯利 (Mark Crossley)。

Thank you, Jason, and good morning and good afternoon, everyone, and thanks for joining us at our first-quarter results call today. Here with me are Ryan Preblick, our Chief Financial Officer; and Christian Heidbreder, our Chief Scientific Officer.

謝謝傑森，大家早上好，下午好，謝謝您參加今天的第一季業績電話會議。和我在一起的是我們的財務長 Ryan Preblick；以及我們的首席科學官 Christian Heidbreder。

I'll start the day with an overview of the Q1 results and a progress report against our strategic priorities, and then Ryan will then discuss the Q1 results and our fiscal year 2024 guidance. Following that, we'll provide an update on our primary listing initiative and conclude with questions and answers.

我將首先概述第一季的業績以及針對我們的策略重點的進度報告，然後 Ryan 將討論第一季度的業績和我們 2024 財年的指導。接下來，我們將提供主要上市計劃的最新信息，並以問題和答案作為結束。

Turning to the key messages, led by SUBLOCADE, we delivered another quarter of solid double-digit top-line growth in the first quarter. Total net revenue grew 12% versus year-ago quarter to $284 million. First-quarter adjusted operating profit of $70 million declined modestly versus last year, due to commercial investments behind SUBLOCADE and the acquisition of Opiant, which closed in March last year. We expect to generate positive operating leverage on these investments as we move through the current year.

談到關鍵訊息，在 SUBLOCADE 的引領下，我們在第一季實現了另一個季度兩位數的營收穩定成長。總淨收入較去年同期成長 12%，達到 2.84 億美元。第一季由於 SUBLOCADE 背後的商業投資以及去年 3 月完成的 Opiant 收購，調整後營業利潤為 7,000 萬美元，較去年略有下降。我們預計今年這些投資將產生積極的營運槓桿。

Turning to SUBLOCADE, we delivered year-over-year net revenue growth of 36% in the first quarter, which is in line with our full-year growth expectations. SUBLOCADE's sequential net revenue growth of 2% was lower than we planned. We believe growth in dispenses were negatively impacted by two external forces, including a higher-than-expected rate of Medicaid patient disenrollments and the cyberattack at Change Healthcare.

談到SUBLOCADE，我們第一季的淨收入年增36%，這符合我們的全年成長預期。SUBLOCADE 的淨收入季增率為 2%，低於我們的計劃。我們認為，配藥量的成長受到兩個外部因素的負面影響，包括高於預期的醫療補助患者退出率和 Change Healthcare 的網路攻擊。

Let me provide more color on how each of these impacted SUBLOCADE's growth in the quarter and why we remain confident in our full-year 2024 net revenue guidance. First, the most recent data on Medicaid renewals indicates a higher-than-expected number of patient disenrollments of over 20 million. Recall at the peak during COVID, over 90 million patients were enrolled in Medicaid. This is particularly relevant in opioid use disorder treatment as the nature of the disease means that approximately 70% of our patients are covered by Medicaid. The impact of this disenrollment process will annualize at the end of June, and therefore, this headwind should begin to subside as we move through the second half of the year.

讓我詳細介紹這些因素如何影響 SUBLOCADE 本季的成長，以及為什麼我們對 2024 年全年淨收入指引保持信心。首先，有關醫療補助續約的最新數據顯示，退出醫療補助的患者人數超過 2,000 萬，高於預期。回想一下，在新冠疫情高峰期，超過 9,000 萬名患者參加了醫療補助計畫。這在阿片類藥物使用障礙治療中尤其重要，因為疾病的性質意味著我們大約 70% 的患者享有醫療補助。這一退出過程的影響將在六月底形成年度影響，因此，隨著下半年的到來，這種不利因素應該會開始消退。

Although the impact on SUBLOCADE's growth in the quarter was larger than expected, Medicaid disenrollment was a known dynamic. The cyberattack on Change Healthcare, by contrast, was a completely unexpected disruption.

儘管本季對 SUBLOCADE 成長的影響大於預期，但醫療補助計劃退出是眾所周知的動態。相較之下，針對 Change Healthcare 的網路攻擊是一次完全意想不到的破壞。

Change Healthcare is the largest claims processor in the US, responsible for one in three claims. Change is a crucial connection for healthcare systems, making clinical, administrative, and financial processes simpler and more efficient for payers, providers, and patients. The cyberattack on February 21 impacted new patient and refill adjudication for SUBLOCADE during the first quarter. Though difficult to isolate the financial impact of each of these items, we estimate that on a combined basis, they lowered SUBLOCADE's sequential dispense growth in the US by mid- to high-single-digit percentage rates. In addition, we saw abnormal destocking of $5 million to $7 million during the same timeframe as this Change cyberattack. We would expect stock levels to normalize in the coming months.

Change Healthcare 是美國最大的索賠處理機構，負責三分之一的索賠。變革是醫療保健系統的重要聯繫，使付款人、提供者和患者的臨床、管理和財務流程變得更簡單、更有效率。2 月 21 日的網路攻擊影響了第一季 SUBLOCADE 的新患者和補充裁決。儘管很難分離出每一項的財務影響，但我們估計，在綜合基礎上，它們使 SUBLOCADE 在美國的連續分配成長降低了中高個位數百分比。此外，在此次 Change 網路攻擊的同一時間段內，我們發現庫存異常減少了 500 萬至 700 萬美元。我們預計庫存水準將在未來幾個月內恢復正常。

With the cyberattack behind us and Medicaid renewal annualizing at the end of June, we look forward to subsiding impacts from these transitory items, which we believe are masking the strong underlying demand for SUBLOCADE.

隨著網路攻擊的過去以及醫療補助計劃將於 6 月底按年更新，我們期待這些暫時性項目的影響減弱，我們認為這些影響掩蓋了對 SUBLOCADE 的強勁潛在需求。

In fact, early dispense trends in April are tracking back to the growth levels we had expected in the first quarter. Additionally, we expect this strong underlying demand will be further bolstered over the remainder of the year by our expanded sales force, which is now fully deployed, and by our continued strong performance in the justice system channel.

事實上，四月的早期分配趨勢正在回溯到我們在第一季預期的成長水準。此外，我們預計，在今年剩餘時間內，我們擴大的銷售隊伍（現已全面部署）以及我們在司法系統管道的持續強勁表現將進一步支撐這一強勁的潛在需求。

The justice system now accounts for approximately 25% of SUBLOCADE's US net revenue. And in the first quarter, we saw continued strong momentum in this channel, with double-digit dispense growth versus the prior quarter. For these reasons, we're confident that total net revenue and adjusted operating profit will accelerate through the year from the first quarter, particularly in the second half, and we reconfirm our fiscal year 2024 guidance.

目前，司法系統約佔 SUBLOCADE 美國淨收入的 25%。在第一季度，我們看到該通路持續強勁的勢頭，與上一季相比，分配量成長了兩位數。基於這些原因，我們有信心總淨收入和調整後營業利潤將從第一季開始全年加速成長，特別是在下半年，我們再次確認了 2024 財年的指導。

Finally, after receiving strong support from shareholders, we're confirming our intention to move forward with a shareholder vote to affect the primary US listing. We and the Board believe this is the right long-term move for shareholders and our business, and we appreciate the engagement and feedback we've received.

最後，在獲得股東的大力支持後，我們確認打算透過股東投票來影響在美國的首次上市。我們和董事會相信，這對股東和我們的業務來說是正確的長期舉措，我們感謝我們收到的參與和回饋。

Moving next to our report card for the first quarter, we continue to make good progress against our strategic priorities to drive value creation. I've described in detail the dynamics in the quarter related to SUBLOCADE's growth. I'll briefly discuss some additional items here that highlight our continued strong year-over-year progress with SUBLOCADE and that provide us with confidence in our future growth.

接下來是第一季的成績單，我們繼續在推動價值創造的策略重點方面取得良好進展。我已經詳細描述了本季與 SUBLOCADE 成長相關的動態。我將在這裡簡要討論一些其他項目，這些項目突出了我們與 SUBLOCADE 的持續強勁的逐年進展，並使我們對未來的成長充滿信心。

First, the number of patients receiving SUBLOCADE grew approximately 59% year over year to 150,000 at the quarter end. This is noteworthy as it is now more than halfway towards the estimated 270,000 patients we're targeting to achieve our $1.5 billion-plus net revenue goal. While we're pleased with our progress, we're still only reaching a small portion of the 3.1 million diagnosed opioid use disorder patients in the US and the over 10 million that report misusing opioids.

首先，接受 SUBLOCADE 治療的患者人數年增約 59%，截至季末達到 15 萬人。這是值得注意的，因為現在距離我們預計的 27 萬名患者實現 15 億美元以上淨收入目標已完成一半以上。雖然我們對所取得的進展感到滿意，但我們仍然只涵蓋了美國 310 萬名確診阿片類藥物使用障礙患者和超過 1000 萬名報告濫用鴉片類藥物的患者中的一小部分。

Our strong underlying performance across key SUBLOCADE metrics reflects continued successful penetration of organized health systems in the US justice system. We're increasing SUBLOCADE's prescribing depth across our existing OHS customers and gaining access to new ones. In total, SUBLOCADE has access to over 1,000 distinct organized health systems. We've also furthered SUBLOCADE's access to an additional 50 justice system entities in the quarter. As a result, active healthcare practitioners prescribing SUBLOCADE increased over 30% year over year to almost 7,000. And those prescribing to five or more patients, which we view as adopters, grew approximately 30% year over year to almost 3,000. As I previously mentioned, we expect to build on this momentum with the recent commercial investments behind SUBLOCADE.

我們在關鍵 SUBLOCADE 指標上的強勁基礎表現反映了有組織的衛生系統在美國司法系統中持續成功的滲透。我們正在增加 SUBLOCADE 在現有 OHS 客戶中的處方深度，並獲得新客戶。SUBLOCADE 總共可以存取 1,000 多個不同的有組織的衛生系統。我們還在本季進一步擴大了 SUBLOCADE 對另外 50 個司法系統實體的存取權限。因此，積極開立 SUBLOCADE 處方的醫療保健從業人員比去年同期增加了 30% 以上，達到近 7,000 名。那些為 5 名或更多患者開處方的患者（我們視為採用者）年增約 30%，達到近 3,000 名。正如我之前提到的，我們希望透過最近對 SUBLOCADE 背後的商業投資來鞏固這一勢頭。

Our increased field force will allow more detailed frequency to organize health system-affiliated physicians. And we will also target non-OHS office-based practitioners as part of our alternate sites of care initiative. Our main partner in this effort today is Albertsons. We're still gaining experience here, but the signs continue to be promising. To share a couple of metrics, the number of Albertsons locations performing injections for patients has doubled since last quarter to almost 80, and the number of patient injections at Albertsons grew by almost 50% sequentially. Based on this encouraging start, we're continuing to explore additional partnerships to help grow patient access with independent HCPs with a nationwide alternate site of care network.

我們增加的現場人員將允許更詳細地組織衛生系統附屬醫生。我們也將針對非 OHS 辦公室從業人員作為我們替代護理地點計劃的一部分。今天我們在這項工作中的主要合作夥伴是艾伯森 (Albertsons)。我們仍在累積經驗，但跡象仍然充滿希望。分享幾個指標：自上季度以來，為患者進行注射的 Albertsons 門市數量增加了一倍，達到近 80 個，Albertsons 的患者註射數量環比增長了近 50%。基於這一令人鼓舞的開端，我們將繼續探索更多合作夥伴關係，透過全國性的備用護理網絡站點，幫助增加患者與獨立 HCP 的聯繫。

Moving next to diversification, starting with SUBLOCADE outside the US, which is now in six markets, we again saw strong year-over-year growth of over 30%. In addition to solid progress in Canada, we saw an increase in uptake in the Nordics and Germany during the quarter. Our other new ex-US launch, SUBOXONE Film, also showed growth from continued expansion across Canada and greater regional access across EU countries.

接下來是多元化，從美國以外的 SUBLOCADE 開始，目前已遍布六個市場，我們再次看到了超過 30% 的強勁同比增長。除了加拿大的堅實進展外，本季我們還看到北歐和德國的使用量增加。我們在美國以外推出的另一款新產品 SUBOXONE Film 也顯示出由於在加拿大的持續擴張以及在歐盟國家的更大區域准入而實現的增長。

Turning to PERSERIS, while competition has intensified in the risperidone LAI category, once-monthly risperidone products are gaining share rapidly, and the overall category is still growing. Against this backdrop, we continue to highlight PERSERIS' unique product profile, which continues to result in positive anecdotal prescriber feedback on product performance. Sequential dispense growth was 10%, not only underscoring the good underlying momentum we're seeing, but also representing an acceleration from previous quarters.

談到PERSERIS，雖然利培酮LAI類別的競爭加劇，但每月一次的利培酮產品正在迅速獲得份額，並且整體類別仍在增長。在此背景下，我們繼續強調 PERSERIS 獨特的產品概況，這繼續帶來處方醫生對產品性能的正面回饋。連續分配成長率為 10%，不僅凸顯了我們所看到的良好的潛在勢頭，而且也代表了較前幾季的加速成長。

We expect to augment our efforts with PERSERIS at the publication of real-world evidence studies in the second half of 2024. Taken together, we remain confident in our full-year net revenue guidance for PERSERIS and expect accelerating net revenue moving forward.

我們預計在 2024 年下半年發布真實世界證據研究時，將透過 PERSERIS 加強我們的努力。總的來說，我們對 PERSERIS 的全年淨收入指引仍然充滿信心，並預計未來淨收入將加速成長。

Lastly, on diversification, OPVEE net revenue was modest, as expected. Our continued near-term focus is on laying the foundation for OPVEE success by changing policy to enable the growth of nalmefene rescue and ensuring the availability of funding. To date, 31 states standing orders include OPVEE.

最後，在多元化方面，正如預期的那樣，OPVEE 淨收入不大。我們近期的持續重點是透過改變政策以促進納美芬救援的成長並確保資金的可用性，為 OPVEE 的成功奠定基礎。迄今為止，已有 31 個州的常規命令包含 OPVEE。

Furthermore, all SAMHSA grants have been updated to include all FDA-approved overdose rescue medications, and state and local abatement funds can also be used to purchase overdose rescue medications, including OPVEE. This is important foundational work, which we expect to result in increased trial and adoption and accelerating net revenue growth as the year progresses. You should also note that we expect to fulfill the first $8 million requisition of OPVEE from BARDA by the third quarter.

此外，所有 SAMHSA 撥款均已更新，包括 FDA 批准的所有過量救援藥物，州和地方減排資金也可用於購買過量救援藥物，包括 OPVEE。這是一項重要的基礎工作，我們預計這將導致更多的試驗和採用，並隨著時間的推移加速淨收入成長。您還應該注意到，我們預計將在第三季之前完成 BARDA 的第一批 800 萬美元的 OPVEE 採購訂單。

As the only overdose rescue medication that is specifically indicated for synthetic opioids like fentanyl, the potential for OPVEE to save lives is tremendous in light of the current wave of overdose deaths, caused by powerful synthetic opioids.

作為唯一專門用於芬太尼等合成鴉片類藥物的過量救援藥物，鑑於目前由強效合成鴉片類藥物引起的過量服用死亡浪潮，OPVEE 拯救生命的潛力巨大。

Turning to our pipeline, Christian is here to answer any specific questions. I would highlight that we expect the pace of development activity to pick up over the balance of the year. This quarter, we'll be initiating a Phase 2 clinical proof-of-concept study for INDV-2000, our Orexin-1-based non-opioid for opioid use disorder.

談到我們的管道，克里斯蒂安在這裡回答任何具體問題。我想強調的是，我們預計開發活動的步伐將在今年剩餘時間內加快。本季度，我們將啟動 INDV-2000 的 2 期臨床概念驗證研究，這是我們基於 Orexin-1 的非阿片類藥物，用於治療阿片類藥物使用障礙。

In the third quarter, we expect to receive the top-line results of the clinical Phase 2b study for AEF-0117, our partnered asset for cannabis use disorder. After analyzing the data and meeting with the FDA in the end of Phase 2 meeting, we will ultimately make a decision on whether to exercise our option for $100 million and to proceed to Phase 3 trials. Also in Q3, we expect to begin PK studies in support of future Phase 3 studies for INDV-6001, a potential three-month buprenorphine-based LAI targeting opioid use disorder. So a very busy year ahead for Christian and his team.

在第三季度，我們預計將收到 AEF-0117 臨床 2b 期研究的主要結果，AEF-0117 是我們針對大麻使用障礙的合作資產。在分析數據並在第二階段會議結束時與 FDA 會面後，我們最終將決定是否行使 1 億美元的選擇權並繼續進行第三階段試驗。同樣在第三季度，我們預計將開始PK 研究，以支持INDV-6001 未來的3 期研究，INDV-6001 是一種針對阿片類藥物使用障礙的潛在的為期三個月的基於丁丙諾啡的LAI。對於克里斯蒂安和他的團隊來說，接下來的一年將非常忙碌。

Lastly, on our fourth strategic pillar, operating model and capital allocation, Ryan will walk you through the cash movements, but I'll quickly touch on a couple of items. First, the conversion of the Raleigh site for future production of SUBLOCADE is proceeding well. Second, with regards to the potential primary US listing of our shares, we're scheduling a shareholder vote on May 23. If approved by shareholders, we would expect to transition our primary listing in late June.

最後，關於我們的第四個策略支柱、營運模式和資本配置，瑞安將引導您了解現金流動情況，但我將快速談及幾個專案。首先，用於未來生產 SUBLOCADE 的羅利工廠的改造進展順利。其次，關於我們股票可能在美國首次上市的問題，我們計劃在 5 月 23 日進行股東投票。如果獲得股東批准，我們預計將在六月下旬過渡主要上市。

Before concluding my remarks, I just wanted to remind you of the key elements of the medium-term profitable growth framework that we provided in December 2022 and how we are tracking toward this. As you've heard today, we delivered double-digit net revenue growth in the first quarter, and we expect the pace to accelerate over the balance of the year as we move beyond the transitory impacts on SUBLOCADE and see growing returns from our commercial investments. We expect this, in turn, to deliver positive operating leverage and accelerated growth in adjusted operating profit. Taken together, we remain confident that we're on track to meet both our fiscal-year 2024 guidance and our medium-term goals.

在結束我的演講之前，我只是想提醒大家我們在 2022 年 12 月提供的中期盈利增長框架的關鍵要素以及我們如何跟踪這一目標。正如您今天所聽到的，我們在第一季實現了兩位數的淨收入增長，隨著我們超越對SULOCADE 的短暫影響並看到我們的商業投資回報不斷增長，我們預計今年剩餘時間的增長速度將會加快。我們預計這反過來將帶來積極的營運槓桿並加速調整後營運利潤的成長。總的來說，我們仍然相信我們有望實現 2024 財年指導和中期目標。

With that, I'll hand it over to Ryan for a review of the financials, and then we'll open it up to Q&A.

這樣，我會將其交給 Ryan 進行財務審查，然後我們將進行問答。

Thanks, Mark, and good morning and good afternoon to everyone. Overall, I'm pleased to report a solid quarter of execution considering the unexpected headwinds in the quarter that Mark referenced. Looking at the first-quarter results in more detail, starting with the top line, total net revenue of $284 million through 12% versus the year-ago quarter on a reported and on a constant currency basis.

謝謝，馬克，大家早安，下午好。總的來說，考慮到馬克提到的本季的意外阻力，我很高興地報告本季的執行情況。更詳細地看一下第一季的業績，從營收開始，按報告和固定匯率計算，總淨收入為 2.84 億美元，與去年同期相比成長 12%。

By geography, total US net revenue in the first quarter grew by 15%, versus the year-ago quarter driven by SUBLOCADE. The rest of the world was down 2% on a reported and on a constant currency basis. In the rest of the world, Q1 was slightly impacted by shipment timing. We did see good growth from SUBLOCADE outside the US with net revenue up 33% to $12 million. And overall, we continue to expect the rest of the world to grow in full year 2024.

按地區劃分，在 SUBLOCADE 的推動下，第一季美國總淨收入與去年同期相比成長了 15%。根據報告和固定匯率計算，世界其他地區下降了 2%。在世界其他地區，第一季受到發貨時間的輕微影響。我們確實看到了美國以外地區 SUBLOCADE 的良好成長，淨收入成長了 33%，達到 1,200 萬美元。總體而言，我們繼續預計世界其他地區將在 2024 年全年實現成長。

For total SUBLOCADE, we delivered year-over-year net revenue growth of 36% in the first quarter. Although this was in line with the midpoint of our full-year guidance expectations, SUBLOCADE sequential net revenue growth of 2% and US dispense growth of 4% were both lower than expected. Both metrics were affected by the items Mark discussed, which I will expand on.

對於總 SUBLOCADE 而言，我們第一季的淨收入年增 36%。儘管這與我們全年指導預期的中點一致，但 SUBLOCADE 2% 的連續淨收入成長和 4% 的美國分配成長均低於預期。這兩個指標都受到馬克討論的項目的影響，我將對此進行擴展。

First, as we just detailed, Medicaid disenrollment dynamics had a disproportionate impact on our company as more than two-thirds of SUBLOCADE patients are covered by Medicaid. This impact accelerated in Q1 beyond the low-single-digit headwind we had seen in prior quarters. Looking ahead, we expect this trend to begin subsiding in the second half of 2024, as Mark noted.

首先，正如我們剛才詳述的，醫療補助退出動態對我們公司產生了不成比例的影響，因為超過三分之二的 SUBLOCADE 患者都受到醫療補助的覆蓋。這種影響在第一季加速，超過了我們在前幾個季度看到的低個位數逆風。展望未來，正如 Mark 所指出的那樣，我們預計這一趨勢將在 2024 年下半年開始消退。

Second, as a result of the Change cyberattack, many SUBLOCADE treatment providers were unable to process claims and verify patient eligibility. This impacted our SUBLOCADE net revenue performance in the latter part of the quarter through two dynamics.

其次，由於 Change 網路攻擊，許多 SUBLOCADE 治療提供者無法處理索賠並驗證患者資格。這透過兩個動態影響了我們的 SUBLOCADE 在本季後半段的淨收入表現。

First, we believe it resulted in a significant reduction in dispenses for new patients in March, compared to the solid dispense rates we saw in the first two months of the year. Second, we believe it had an adverse impact on refill dispenses for existing patients, where re-eligibility was required for treatment continuation, so a disconnect in our hysterical retention curves beginning with the onset of the late February cyberattack. Taking these two items together, we estimate the impact on US SUBLOCADE dispense growth in the first quarter to have been in the mid- to high-single-digit percentage range.

首先，我們認為與今年前兩個月的固體配藥率相比，這導致 3 月新患者的配藥量顯著減少。其次，我們認為這對現有患者的補充配藥產生了不利影響，因為繼續治療需要重新獲得資格，因此從 2 月底網路攻擊開始，我們的歇斯底里保留曲線就出現了脫節。將這兩個綜合考慮，我們估計第一季對美國 SUBLOCADE 分配成長的影響將在中高個位數百分比範圍內。

Turning to the difference between the sequential 4% dispense growth and the 2% net revenue growth, this primarily reflects unexpected destocking of SUBLOCADE in the US, which we estimate at between $5 million and $7 million. This destock was atypical compared to historic inventory trends and occurred in the same timeframe as the Change attack.

至於連續 4% 的分配成長和 2% 的淨收入成長之間的差異，這主要反映了 SUBLOCADE 在美國的意外去庫存，我們估計在 500 萬至 700 萬美元之間。與歷史庫存趨勢相比，這次庫存減少是非典型的，並且與變更攻擊發生在同一時間範圍內。

Moving to PERSERIS, reported net revenue of $11 million was up 38% versus the prior year and down 8% sequentially, due to low-single-digit million destocking in the quarter. Encouragingly, dispenses are up 10% sequentially. We remain confident in meeting our full-year net revenue guidance of $55 million to $65 million.

轉向 PERSERIS，報告的淨收入為 1100 萬美元，比上一年增長 38%，環比下降 8%，原因是本季度庫存減少幅度為個位數。令人鼓舞的是，分配量較上季增加了 10%。我們仍有信心實現 5,500 萬至 6,500 萬美元的全年淨收入指引。

OPVEE net revenue was modest in the first quarter as we continue to lay the foundational components for the launch, as Mark detailed. We continue to expect full-year net revenue of $15 million to $25 million, including an $8 million product order from BARDA.

OPVEE正如馬克詳細介紹的那樣，隨著我們繼續為發布奠定基礎，第一季的淨收入不大。我們仍預計全年淨收入為 1500 萬至 2500 萬美元，其中包括來自 BARDA 的 800 萬美元產品訂單。

Turning to SUBOXONE Film in the US, the average share of approximately 17% in the first quarter was down about 1 percentage point versus the fourth quarter and 2 percentage points versus the year-ago quarter, all within expectations. As a reminder, we do not promote SUBOXONE Film in the US.

至於美國的SUBOXONE Film，第一季的平均份額約為17%，較第四季下降約1個百分點，較去年同期下降2個百分點，均在預期之內。提醒一下，我們不在美國推廣 SUBOXONE 薄膜。

Moving down to P&L, our first-quarter adjusted gross margin of 85% was flat versus the prior-year quarter. The higher mix of SUBLOCADE and favorable manufacturing variances, which also benefited Q1 last year, were largely offset by cost inflation. We continue to expect the full-year gross margin to be within our guidance range of low to mid 80%.

轉向損益表，我們第一季調整後毛利率為 85%，與去年同期持平。子定位的較高組合和有利的製造差異也使去年第一季受益，但在很大程度上被成本通膨所抵消。我們繼續預計全年毛利率將在 80% 中低水準的指導範圍內。

Adjusted SG&A expenses were $143 million in the quarter of 22% versus Q1 of last year. This increase primarily reflects the incremental SUBLOCADE commercial investments, which are now fully in place, and the addition of the Opiant business, including launch expenses for OPVEE.

本季調整後的 SG&A 費用為 1.43 億美元，比去年第一季成長 22%。這一成長主要反映了目前已完全到位的 SUBLOCADE 商業投資增量，以及 Opiant 業務的增加，包括 OPVEE 的啟動費用。

R&D expenses were $28 million in the quarter, an increase of 4% versus Q1 of last year. The increase primarily reflects work to advance early stage assets and Phase 4 studies for SUBLOCADE. Given the pace of development activity is expected to pick up, this will result in an uptick in R&D expense over the balance of 2024.

本季研發費用為 2,800 萬美元，比去年第一季成長 4%。這一增長主要反映了推進早期資產和 SUBLOCADE 第 4 階段研究的工作。鑑於開發活動的步伐預計將加快，這將導致 2024 年剩餘時間的研發費用增加。

Our adjusted operating profit of $70 million in Q1 was down 1% from Q1 of last year, due to a combination of the net revenue dynamics that I have highlighted and the commercial investment behind SUBLOCADE and Opiant.

由於我強調的淨收入動態以及 SUBLOCADE 和 Opiant 背後的商業投資，我們第一季調整後的營業利潤為 7,000 萬美元，比去年第一季下降了 1%。

Lastly, on the P&L, our adjusted net income of $51 million decreased 9% versus Q1 of last year, reflecting the dynamics I just highlighted, in addition to modest net finance expenses.

最後，在損益表上，我們調整後的淨利潤為 5,100 萬美元，與去年第一季相比下降了 9%，除了適度的淨財務費用外，還反映了我剛才強調的動態。

Quickly touching on the balance sheet and our capital position, we ended the first quarter with gross cash investments of $356 million. Material cash outflows during the quarter included scheduled annual settlement payments of $70 million to the DOJ, RB, and DRL and share repurchases of $36 million.

快速回顧一下資產負債表和我們的資本狀況，第一季末我們的現金投資總額為 3.56 億美元。本季的重大現金流出包括計劃向 DOJ、RB 和 DRL 支付 7,000 萬美元的年度和解金，以及 3,600 萬美元的股票回購。

Looking ahead, we expect to maintain good financial flexibility and to continue our disciplined capital allocation strategy. In the near term, this remains focused on reinvesting to fuel our base business towards our net revenue goals and meeting our stakeholder obligations. As always, if there is excess cash, we will examine opportunities for business development and potential shareholder returns.

展望未來，我們預計將保持良好的財務靈活性，並繼續實施嚴格的資本配置策略。短期內，我們的重點仍然是再投資，以推動我們的基礎業務實現我們的淨收入目標並履行我們的利害關係人義務。一如既往，如果有多餘的現金，我們將研究業務發展的機會和潛在的股東回報。

We have discussed a number of the external dynamics, which impacted SUBLOCADE results in the quarter. Based on our expectations for a resolution of these transitory headwinds and continued strong business execution, we remain comfortable with our guidance elements for full year 2024, including SUBLOCADE net revenue of $820 million to $880 million, and an expected increase in adjusted operating margin of around 300 basis points at the midpoint.

我們討論了一些影響 SUBLOCADE 本季表現的外部動態。基於我們對解決這些暫時性不利因素和持續強勁的業務執行力的預期，我們對2024 年全年的指導要素仍然感到滿意，包括SUBLOCADE 淨收入為8.2 億至8.8 億美元，調整後營業利潤率預計將成長約中間點300個基點。

I will now turn the call back over to Mark.

我現在將把電話轉回給馬克。

Thank you, Ryan. I want to close with some additional detail on our proposed transition to a primary US listing while maintaining our secondary listing in the UK. As I highlighted earlier, we have received strong support from shareholders, and so it is our intention to move forward to a shareholder vote on May 23. If approved, we are targeting an effective date in late June.

謝謝你，瑞安。最後，我想就我們提議的向美國主要上市過渡同時維持在英國二次上市的計劃提供一些額外的細節。正如我之前強調的，我們得到了股東的大力支持，因此我們打算在 5 月 23 日進行股東投票。如果獲得批准，我們的目標是六月下旬生效。

Subject to shareholder approval and as part of this effort, we're planning a number of investor awareness roadshow meetings, as well as comprehensive analyst teach-in on May 23 in New York City, the same day as the shareholder vote, earlier that day. Some virtual details of the analyst teach-in will be provided on our website. Assuming the US primary listing proceeds, we intend to transition to reporting in US GAAP beginning in January 1, 2025, and thereafter. We plan to provide an update later in 2024 regarding this process, during which we will set out the key reconciling items compared with our current IFRS reporting.

作為這項工作的一部分，經股東批准，我們計劃於 5 月 23 日（即股東投票的同一天，即當天早些時候）在紐約市舉行一系列投資者意識路演會議以及全面的分析師宣講會。我們的網站上將提供分析師宣講的一些虛擬詳細資訊。假設美國首次上市繼續進行，我們打算從 2025 年 1 月 1 日起及之後過渡到按照美國公認會計原則進行報告。我們計劃在 2024 年稍後提供有關此流程的更新，在此期間我們將列出與目前 IFRS 報告相比的關鍵調節項目。

With that, I will turn it over to Evan to facilitate Q&A.

這樣，我會將其交給 Evan 以便進行問答。

(Operator instructions) James Vane-Tempest, Jefferies.

（操作員說明）James Vane-Tempest，Jefferies。

Thanks very much for taking my questions. I have three if I can, please. Firstly, just on the SUBLOCADE ex-US, I think you mentioned six countries. I was just wondering where it is launched at ex-US?

非常感謝您回答我的問題。如果可以的話，我有三個。首先，就美國以外的子位置而言，我認為您提到了六個國家。我只是想知道它在美國以外的哪裡推出？

The second question is, just when I look at the SUBLOCADE and the performance and these versus consensus, it seems to be around $15 million or so. So I guess, when we look at the guidance given Q4 from memory is sort of seasonally weaker, is it fair to say you are more likely going to be at the lower end of your guidance?

第二個問題是，當我查看 SUBLOCADE 和效能以及這些與共識的比較時，它似乎約為 1500 萬美元左右。因此，我想，當我們根據記憶查看第四季度的指導時，季節性疲軟，可以公平地說，您更有可能處於指導的下限嗎？

And then the third question is just around destocking you saw. Is that potentially related to the Change attack? I mean, can you give us a sense in terms of what the customer visibility you have is, please? Thank you.

第三個問題是關於你所看到的去庫存。這是否可能與 Change 攻擊有關？我的意思是，您能為我們介紹一下您的客戶知名度嗎？謝謝。

Thanks for those questions, James. Just to start with the first one on the ex-US SUBLOCADE markets, we are in Finland, Germany, Sweden, Australia, Canada, and Israel. So those are the markets that we are currently in. With regards to your question on -- I am going to start with the destocking and then build to the consensus.

謝謝你提出這些問題，詹姆斯。首先從美國以外的 SUBLOCADE 市場的第一個開始，我們在芬蘭、德國、瑞典、澳洲、加拿大和以色列。這些就是我們目前所處的市場。關於你的問題——我將從去庫存開始，然後逐步達成共識。

What we saw was, we saw destocking in the period, and we have reached out to our partners because we saw the weeks of stocking drop from 2.1 to 1.7, equating to the 5 to 7 that we talked about. And as we talked to the partners, they indicated broadly there were no plans to reduce their stocking. What we believe is with the disconnect and the data they use for their algorithms on inventory that that caused the decrease in days. So we believe there is a connection to the Change cyberattack.

我們看到的是，我們看到了這段期間的去庫存，我們已經聯繫了我們的合作夥伴，因為我們看到庫存週數從2.1 週減少到1.7 週，相當於我們談到的5 週到7 週。當我們與合作夥伴交談時，他們普遍表示沒有計劃減少庫存。我們認為，由於脫節以及他們用於庫存演算法的數據導致了天數的減少。因此我們相信這與 Change 網路攻擊有關。

As relates to consensus in the lower end, we've done a significant amount of work in this place. I'll start with first, there is such a tremendous unmet need in the space, less than 2 in 10 people in treatment. SUBLOCADE is still early in growth with just under a 6% share. Strategically, our structure, the excellence of execution by the team and the differentiated product profile that we have, we've looked at the building blocks in the balance to go as we regain and pass through the transitory items. Strong CGS growth, which is over 20% quarter on quarter, as well as the sales force expansion, which increases our reach and frequency and have comfort with the entire range of $820 million to $880 million for SUBLOCADE.

至於低階的共識，我們在這方面做了大量的工作。首先，這個領域存在著巨大的未滿足需求，不到十分之二的人正在接受治療。SUBLOCADE 仍處於成長早期，佔比略低於 6%。從策略上講，我們的結構、團隊的卓越執行力以及我們擁有的差異化產品概況，我們已經研究了我們重新獲得並透過臨時專案時平衡的基石。CGS 的強勁成長（季度環比增長超過 20%）以及銷售隊伍的擴張，增加了我們的覆蓋範圍和頻率，並對 SUBLOCADE 的 8.2 億至 8.8 億美元的整個範圍感到滿意。

Thank you.

謝謝。

Thank you, James.

謝謝你，詹姆斯。

Max Herrmann, Stifel.

馬克斯·赫爾曼，斯蒂菲爾。

Great. Thanks very much for taking my questions. I've got a few, I'll limit it to three at the moment, maybe come back later. Just trying to -- first of all, just touch on SUBOXONE Film and the volatility kind of month on month or quarter on quarter was driving that. Because obviously, you have this odd quarter where the rebating impacts the reported number when you changed the rebate provision. I wonder whether there was anything within the first quarter that led to that decline from the fourth quarter? That is kind of first question.

偉大的。非常感謝您回答我的問題。我有一些，目前我會限制為三個，也許稍後再回來。首先，我想談談 SUBOXONE 薄膜，逐月或逐季的波動是造成這種情況的原因。因為顯然，當您更改回扣規定時，您會遇到這個奇怪的季度，回扣會影響報告的數字。我想知道第一季是否有什麼因素導致第四季下滑？這是第一個問題。

Secondly, just in terms of the litigation on the tooth decay, I noticed there is now 325 cases? Kind of interested to know if you have a view on how many of those are sort of single tooth, because I believe the judges commenting that those will never get to a significant claims of, the kind of now the plaintiff lawyers are trying to exclude those from future cases. So I just wanted to understand that.

第二，就蛀牙訴訟而言，我注意到現在有325件案件？我很想知道您是否對其中有多少是單牙有看法，因為我相信法官評論說這些永遠不會得到重大索賠，而現在原告律師正試圖排除這些索賠從未來的案例來看。所以我只是想了解這一點。

And then in terms of Albertsons, you talked a little bit about the growth in terms of the sales force that's now effective. I'd be interested to know, is the timing of that and whether we are really just like the start of the growth potential there. So I'll leave it with that for now. Thank you.

然後，就艾伯森而言，您談到了目前有效的銷售團隊的成長。我很想知道，時機是什麼，以及我們是否真的像那裡的成長潛力的開始。所以我暫時就這樣吧。謝謝。

Thank you for those, Max. Maybe what I will do is I will cover those in reverse order. I will cover the Albertsons growth, the litigation, and then I will hand over to Ryan to talk through the SUBOXONE Film sort of dynamics.

謝謝你，馬克斯。也許我會以相反的順序介紹這些內容。我將報道艾伯森的成長和訴訟，然後我將交給瑞安談談 SUBOXONE 電影的動態。

So let's start with Albertsons. I think you've kind of indicated where we are. This is the very early stages of reopening independent physician's ability to prescribe SUBLOCADE. Because of the administrative nature, these alternate sites of care alleviate that burden by being able to go there. Very pleased to be partnering with Albertsons, have some good coverage, but it is certainly not a seamless nationwide network that we're looking to create through time, so we are in very early days of this. We spoke to an increased sales force to increase the reach and frequency in both our organized health systems but have the capacity to start to call on these independent physicians. That sales force was just put in place in the first quarter, so they are just out there.

讓我們從艾伯森開始。我想你已經表明了我們的處境。這是重新開放獨立醫生開立 SUBLOCADE 處方的能力的早期階段。由於行政性質，這些替代護理地點通過能夠前往那裡減輕了負擔。很高興與艾伯森合作，擁有一些良好的覆蓋範圍，但這肯定不是我們希望隨著時間的推移創建的無縫全國網絡，所以我們還處於早期階段。我們與增加的銷售人員進行了交談，以增加我們有組織的衛生系統的覆蓋範圍和頻率，但有能力開始拜訪這些獨立醫生。該銷售隊伍在第一季剛剛到位，所以他們就在那裡。

In addition, the team in the home office, as you can imagine, is working a portfolio of partners, to broaden that network so that it is nationwide coverage and as close to the retail network as we can get. We'll never get there, but that is our aspiration is to have these as close to the patients as we can be. So very early days on that, and this will be quarters before we start to build out that nationwide network.

此外，正如您可以想像的那樣，總部的團隊正在與一系列合作夥伴合作，以擴大該網絡，使其覆蓋全國，並儘可能靠近零售網絡。我們永遠無法實現這一目標，但我們的願望是讓這些產品盡可能貼近患者。因此，這還處於早期階段，距離我們開始建立全國性網路還有幾個季度。

On the litigation, absolutely right. We highlighted the 325 cases. I think for me, the disclosure has been updated, but the key here is it's a very early stages of the case. This is only recently become an NDL. There have only been a few status conferences with the judge, most of those are procedural in nature. Given the statute of limitation, expecting to expire in June, we are expecting to have more cases here. And throughout time, we'll understand, one, the number, and then we will start to work through what the cases look like as discovery begins. But again, it is very early stages and unable to comment with regards to the quality of the individual cases.

關於訴訟，絕對正確。我們重點介紹了 325 起案件。我認為對我來說，披露已經更新，但這裡的關鍵是這是案件的非常早期階段。這最近才成為 NDL。僅與法官進行了幾次情況會議，其中大多數都是程序性的。鑑於訴訟時效預計六月到期，我們預計這裡會出現更多案件。隨著時間的推移，我們將了解，第一，數字，然後隨著發現的開始，我們將開始研究案件的情況。但同樣，現在還處於非常早期的階段，無法對個別案例的品質發表評論。

I will note one more thing with regards to that, and we have included an update in the disclosure, is we have alerted our insurers, our product liability insurers, with regards to the case. They have agreed to pay defense costs, but have filed a notice of reservation with regards to coverage on the product liability side, which our lawyers have indicated is customary for these sorts of matters.

與此相關，我還要指出一件事，我們已在披露中包含了更新，即我們已就此案向我們的保險公司、我們的產品責任保險公司發出警報。他們已同意支付辯護費用，但已就產品責任方面的承保範圍提交了保留通知，我們的律師表示這是此類問題的慣例。

So Ryan, do you want to talk to the SUBOXONE dynamics?

那麼 Ryan，您想談談 SUBOXONE 的動態嗎？

Good morning, Max. So on SUBOXONE Film, really, there's two things at play here. One, knowing that there are now four generics in the marketplace since last year and the point that we do not promote this product, it was not unexpected that we would lose some share points. At the end of fourth quarter going into Q1, we did lose about a percentage. So that is one of the reasons why you saw the drop from Q4 to Q1.

早安，馬克斯。因此，在 SUBOXONE Film 上，實際上有兩件事在起作用。第一，知道自去年以來市場上已有四種仿製藥，而且我們不推廣該產品，因此我們失去一些份額也就不足為奇了。在第四季末進入第一季時，我們確實損失了大約一個百分比。這就是您看到從第四季度下降到第一季的原因之一。

And then in addition to that, we just run our normal balance sheet reviews every quarter to take a look at our accrual provisions. These assumptions and adjustments are reviewed by PwC. At the end of Q4 2023, we did have a positive trade spend update. And when you looked at Q1, there was no adjustment at that point. So those are the two main reasons of why you are seeing the step down in net revenue on Film.

除此之外，我們每季都會進行正常的資產負債表審查，以查看我們的應計準備金。這些假設和調整均由普華永道審查。2023 年第四季末，我們確實獲得了積極的貿易支出更新。當你看第一季時，你會發現當時沒有任何調整。因此，這是電影淨收入下降的兩個主要原因。

Great. Thank you.

偉大的。謝謝。

Thank you, Max.

謝謝你，麥克斯。

Chase Knickerbocker, Craig-Hallum.

蔡斯·尼克博克、克雷格·哈勒姆。

Good morning, guys. Thanks for taking the questions. So first, I just want to make sure I understand kind of the cumulative effect of these headwinds on SUBLOCADE. Mid- to high single-digit kind of sequential growth headwinds from Change in Medicaid. And then the $5 million to $7 million kind of destocking is on top of that. And then when kind of think of that distributor destocking, should we think of that being a tailwind to Q2? And have you kind of seen that ordering already fill that shortfall so far in April?

早上好傢伙。感謝您提出問題。首先，我想確保我了解這些不利因素對 SUBLOCADE 的累積影響。醫療補助的變化帶來了中到高個位數的連續成長阻力。除此之外，還有 500 萬至 700 萬美元的去庫存。然後，當想到經銷商減少庫存時，我們是否應該認為這是第二季的順風車？您是否看到 4 月迄今為止的訂單已經填補了這一缺口？

So absolutely right on your interpretation on that, Chase, those are additive. The stocking is in addition to the underlying dispensed impacts that we are seeing for both new patients, but also retention in treatment, where we did see a disconnect from our historical retention slant refill rates that we believe in the quarter impacted us by about 6,000 units, so a significant impact where we saw a disconnect and associated with the two transitory items.

所以你的解釋絕對正確，蔡斯，這些都是累積的。除了我們看到的對新患者的潛在分配影響之外，庫存也是對治療保留率的影響，我們確實發現與歷史保留傾斜補充率脫節，我們認為本季度對我們的影響約為 6,000 單位，因此我們看到了與兩個暫時性項目的脫節和關聯，從而產生了重大影響。

On the stocking, we do expect that stocking to return as the data clarity cleans up associated with the Change cyberattack and would expect that whether that is Q2, or into Q3, but over the next coming months. Absolutely, we expect that to come back.

在庫存方面，我們確實預計，隨著與 Change 網路攻擊相關的數據清晰化，庫存將會恢復，並且預計無論是第二季度還是第三季度，但都在接下來的幾個月內。當然，我們希望這種情況能夠回歸。

Got it. Maybe just putting a finer point on kind of the midpoint of SUBLOCADE guidance would indicate kind of stronger than seasonal sequential growth in the last three quarters of the year here. So just to kind of put a fine point on maybe how these headwinds abate and then some of these patients come back and get dosed this quarter and next. So basically kind of mid to late March, there were patients that were not able to get verified for redosing, kind of at that three-month renewal time point. And then there were also patients not able to clear the prior off that were kind of new to therapy. So kind of both those patient groups would likely come on the drug in the April and May timeframe, as systems are kind of back to normal, and things are able to get adjudicated? Is that kind of how we should think about that as kind of a bolster to growth in the midway, midpoint of the year here?

知道了。也許只是對 SUBLOCADE 指導的中點進行更精細的說明，就表明今年最後三個季度的季度連續增長強於季節性連續增長。因此，我想重點說明這些不利因素如何減弱，然後其中一些患者在本季和下季回來接受藥物治療。所以基本上在三月中下旬，有些患者無法在三個月的續約時間點獲得重新用藥的驗證。還有一些患者無法清除先前的治療，這對於治療來說是一種新的治療。那麼，隨著系統恢復正常，事情能夠得到裁決，這兩個患者群體可能會在四月和五月的時間範圍內服用該藥物？我們是否應該這樣看待它，作為今年中期成長的支撐？

I think that's what I would call one factor to the growth. I think, we have a continuing headwind of the managed -- of the Medicaid renewal continuing through to the half year where then we'll annualize that, and that headwind will go away in the back half.

我認為這就是我所說的成長因素之一。我認為，我們在醫療補助續簽方面面臨持續的阻力，持續到半年，然後我們將對其進行年度化，而這種阻力將在下半年消失。

But I think the other elements with regards to the cyberattack and things like that, you're thinking of it correctly. The patients should return to treatment, either by re-adjudicating with the insurance they're in, or if it's Medicaid reentry, they'll go somewhere else to get the insurance coverage, so that will be a tailwind.

但我認為關於網路攻擊和類似事情的其他因素，你的想法是正確的。患者應該重新接受治療，要么通過他們所參加的保險重新裁決，要么如果是醫療補助重新加入，他們會去其他地方獲得保險承保，所以這將是一個順風車。

But also, I can't understate our belief in the proven strategy, structure, and operational excellence of the team. That's just been proven over the last three years, as we've worked towards penetrating organized health systems. The differentiated asset that we have with unprecedented evidence and real-world evidence, especially in a space with synthetic opioids. And when you look to those, CGS, which was not impacted by either change or the Medicaid reentry, grew it over 20% quarter over quarter. And we have a sales force expansion, which increases our capacity over 50%. So we've got a few additional tailwinds to the ones you highlighted with just patient reentry or re-adjudication.

而且，我不能低估我們對團隊經過驗證的策略、結構和卓越營運的信念。這在過去三年中得到了證明，因為我們一直在努力滲透有組織的衛生系統。我們擁有前所未有的證據和現實世界證據的差異化資產，特別是在合成鴉片類藥物的領域。當你觀察這些數據時，CGS 並未受到變化或醫療補助重新加入的影響，它的季度環比增長超過 20%。我們擴大了銷售隊伍，使我們的產能增加了 50% 以上。因此，除了您強調的患者重新進入或重新裁決之外，我們還有一些額外的有利因素。

Got it. And then just last from me, and I'll hop back in queue. Just on CGS, it's fair to say that, that beat your expectations in the quarter, correct? And then, maybe speak to in that channel, if you're hearing about any customers in the criminal justice system doing any sort of competitive sampling, or is that a space where you'd kind of still have that to yourself?

知道了。然後就在我的最後，我會跳回隊列。就 CGS 而言，可以公平地說，本季度超出了您的預期，對嗎？然後，如果您聽說刑事司法系統中的任何客戶正在進行任何形式的競爭性抽樣，也許可以在該管道中進行交談，或者您仍然可以在該空間中進行此類抽樣嗎？

Yeah. I would say in line with expectations, I think we've -- this is earlier on in its journey. We just two years ago put in a dedicated sales force for CGS and have done that. So activation is still early days here. I think when it comes to competition, we expect them to turn to criminal justice. But I think, with our unique profile of a product in which you get to therapeutic levels in four to eight hours, that therapeutic level is 2 to 3 nanograms for the 100-milligram dose. It's 5 to 6 nanograms per mil. On the 300-milligram dose that lasts the entire month long, we think we have a unique offering in the criminal justice system channel versus competition.

是的。我想說，符合預期，我認為我們已經——這是其旅程的早期階段。就在兩年前，我們為 CGS 組建了一支專門的銷售隊伍，並且已經做到了這一點。所以這裡的激活還處於早期階段。我認為當談到競爭時，我們希望他們轉向刑事司法。但我認為，憑藉我們獨特的產品特點，您可以在四到八小時內達到治療水平，100 毫克劑量的治療水平為 2 到 3 奈克。其含量為每密耳 5 至 6 奈克。對於持續整個月的 300 毫克劑量，我們認為與競爭相比，我們在刑事司法系統管道中擁有獨特的產品。

Great. Thanks, guys.

偉大的。多謝你們。

Thank you, Chase.

謝謝你，蔡斯。

Thibault Boutherin, Morgan Stanley.

蒂博·布瑟林，摩根士丹利。

Thank you very much. First question on the Change attack and the timeline. If you could give us a little bit more details, when did the disruption started exactly? When was it resolved? And just confirming that there is no lingering disruption today.

非常感謝。關於變更攻擊和時間表的第一個問題。如果您能為我們提供更多詳細信息，那麼中斷到底是什麼時候開始的？什麼時候解決的？只是確認今天沒有持續的干擾。

Second question on SUBLOCADE product improvement. You recently, I think, had an approval for a longer shelf life at room temperature. So how much of an impact do you expect this to make? And are you working through any other new improvement or feature for SUBLOCADE or level enhancement that could continue to improve the product profile?

關於SUBLOCADE產品改進的第二個問題。我想，您最近獲得了在室溫下更長保質期的批准。那麼您預計這會產生多大影響？您是否正在研究 SUBLOCADE 或其他等級增強的任何其他新改進或功能，以繼續改進產品設定檔？

And just a last question on the pipeline. The timeline for the three-month formulation license from Alar Pharmaceuticals. Just wondering if you are thinking about traditional development timeline for a new innovative product, which would suggest that it would probably not hit the market before end of this decade, or could this actually go earlier, and could there be a way to accelerate development here, given its reformulation? Thank you.

還有最後一個問題。Alar Pharmaceuticals 三個月製劑許可的時間表。只是想知道您是否正在考慮新的創新產品的傳統開發時間表，這表明它可能不會在本世紀末之前進入市場，或者實際上可能會更早，並且是否有一種方法可以加速這裡的開發，鑑於其重新制定？謝謝。

Thanks for the question, Thibault. I'll handle the first two, and then I'll hand off to Christian, who's with us to talk about that very attractive asset.

謝謝你的提問，蒂博。我將處理前兩個問題，然後將工作交給克里斯蒂安，他和我們一起討論這項非常有吸引力的資產。

So with regards to Change, listen, I think as you look at the timeline, they were impacted by the cyberattacks starting on February 21. We became aware of it with various press releases that started to hit the wire March 5. With regards to that and have been tracking that quite diligently, hearing subjectively from the field, seeing some of the impacts on data, which is on a 1.5 to 2-week delay. Everything that we're hearing and seeing is that they have put in place the necessary interventions to free that up. I think some of that is indicated by us in the early days of April returning to the dispense growth that we were seeing in the early days of Q1. So I think that's a positive sign that that headwind is being resolved, and the market has adjusted to it, albeit after, about a five-week disruption.

因此，關於 Change，聽著，我認為當你查看時間軸時，他們受到了 2 月 21 日開始的網路攻擊的影響。我們透過 3 月 5 日開始發布的各種新聞稿意識到了這一點。對此，我們一直在非常努力地跟踪，從現場主觀地聽取意見，看到對數據的一些影響，即延遲 1.5 到 2 週。我們所聽到和看到的一切都是他們已經採取了必要的干預措施來釋放這種情況。我認為我們在 4 月初就已經表明了其中的一些情況，回到了我們在第一季初期看到的分配成長。因此，我認為這是一個積極的跡象，表明逆風正在解決，市場也已經適應了它，儘管是在經歷了大約五週的干擾之後。

With regards to the SUBLOCADE product improvements, I'll provide some color, and we'll invite Christian to add anything he has on those as well as talk to the three monthly. You're absolutely right, Thibault. We have received improvement for a 12-week out-of-fridge indication. We're currently in the process of trading out that stock, and once we are solely in the 12-week, that will be something we can talk to doctors about. I think that's exciting at the doctor level, because for them, they can only hold product if the patient doesn't show up for a period of 10 weeks or less. So this covers that entire period. And so a physician wouldn't have to have a fridge when working with a specialty pharmacy. So that should help that, albeit we haven't seen a fridge as a barrier in the launch to date, and there's fridges out there. So, this is probably more of a new physician sort of dynamic.

關於 SUBLOCADE 產品改進，我將提供一些顏色，我們將邀請 Christian 添加他所擁有的任何內容，並與三個月月刊進行交談。你說得完全正確，蒂博。我們已收到 12 週不宜冷藏指示的改善。我們目前正在出售該股票，一旦進入 12 週，我們就可以與醫生討論這件事。我認為這對醫生來說是令人興奮的，因為對他們來說，只有患者在 10 週或更短的時間內沒有出現，他們才能保留產品。所以這涵蓋了整個時期。因此，醫生在專業藥局工作時不必擁有冰箱。所以這應該會有所幫助，儘管迄今為止我們還沒有看到冰箱成為發布的障礙，而且那裡有冰箱。所以，這可能更像是一種新的醫生動態。

We are also working on another, a bolus of other sort of items, some for the label and some real-world evidence. I'll speak to the label items. We're working on, as part of our 401 study, alternate injection sites, so that we can move away from the abdomen to back of the arm and the buttocks. And we're also working on rapid induction on our monthly product, and that would be the -- from what we can see for competitors, the only monthly product with rapid induction. We expect those submissions to go to the FDA in Q3. If we get an accelerated review, we could hear back in Q1. If it's a normal review, it looks like Q3 2025.

我們也正在研究另一種產品，一系列其他類型的產品，其中一些用於標籤，一些用於現實世界的證據。我會談談標籤項目。作為 401 研究的一部分，我們正在研究替代注射部位，以便我們可以從腹部轉移到手臂後部和臀部。我們也致力於對我們的月度產品進行快速歸納，從我們對競爭對手的觀察來看，這將是唯一具有快速歸納的月度產品。我們預計這些申請將在第三季提交給 FDA。如果我們得到加速審查，我們可能會在第一季收到回應。如果是正常審核的話，看起來像是 2025 年第三季。

So with that, I'll hand over to Christian for any additional color on those, but also to talk about the Alar asset that we inbounded last year.

因此，我將把這些內容交給克里斯蒂安，以提供更多的信息，同時也談論我們去年引進的阿拉爾資產。

Thank you, Mark. No addition to the label updates. Clearly, in addition to the more formal label update studies, we continue to perform real-world evidence studies, especially to support SUBLOCADE in different subpopulations, including those suffering from psychiatric comorbidities, but also additional evidence in the criminal justice system.

謝謝你，馬克。沒有新增標籤更新。顯然，除了更正式的標籤更新研究之外，我們還繼續進行現實世界的證據研究，特別是支持不同亞群中的SUBLOCADE，包括患有精神共病的人，以及刑事司法系統中的其他證據。

With respect to INDV-6001, the partnership with Alar Pharmaceuticals, we are going to launch a series of multiple pharmacokinetics studies in the third quarter of this year. We are going through a pretty heavy technical transfer from Alar to Indivior as we speak and preparing everything that is going to be required to launch these multiple dose PK studies. That should give us pretty good understanding on the pharmacokinetics profile of this product by the end of 2025, at which point, we will certainly organize an end-of-Phase 2 meeting with the FDA in order to determine the next steps whether or not we can accelerate the pivotal Phase 3 trials. That is something that we will discuss with the agency at that time.

對於與Alar Pharmaceuticals合作的INDV-6001，我們計劃在今年第三季啟動一系列多項藥物動力學研究。在我們發言時，我們正在經歷從 Alar 到 Indivior 的相當繁重的技術轉移，並準備啟動這些多劑量 PK 研究所需的一切。這應該會讓我們在 2025 年底之前對該產品的藥物動力學特徵有很好的了解，屆時，我們肯定會與 FDA 組織一次第二階段結束會議，以確定下一步是否我們可以加速關鍵的第三階段試驗。這是我們屆時將與該機構討論的事情。

Thank you.

謝謝。

Carl Byrnes, Northland Capital Markets, Inc.

卡爾‧伯恩斯 (Carl Byrnes)，北國資本市場公司

Thanks for the question. Most of my questions have been answered, but I'm wondering what you can comment in terms of what you are seeing from competition, specifically from Brixadi, and do you see Brixadi's entry as broadening the demand for long-acting B met therapies? Thanks.

謝謝你的提問。我的大部分問題已得到解答，但我想知道您對從競爭中看到的情況有何評論，特別是來自 Brixadi 的情況，您是否認為 Brixadi 的進入擴大了對長效 B met 療法的需求？謝謝。

Thanks for the question, Carl. Listen, when it comes to launch plans and dynamics, I think I will leave those to the competition and their partners to speak to those. I think, from my standpoint, nothing has changed based on what we are seeing, based on our perception of the market. There's such a huge unmet need in addiction with less than 2 in 10 patients in treatment.

謝謝你的提問，卡爾。聽著，當談到發布計劃和動態時，我想我會將這些留給競爭對手及其合作夥伴來討論。我認為，從我的角度來看，根據我們所看到的情況和我們對市場的看法，一切都沒有改變。成癮方面的需求尚未得到滿足，只有不到十分之二的患者正在接受治療。

Adherence is such an unmet need that there certainly is room for two players in an LAI segment. And I think, we see in, schizophrenia, another space with even less patients diagnosed, that there's multiple players and there is a $4 billion market there with people playing. That said, we remain, based on the dynamics we are seeing, based on where the market is, we still believe in our differentiated profile that SUBLOCADE provides. It is well-suited in this US market where the illicit supply chain has been overtaken by synthetic opioids, backed by five years of HCP patient experience, and it has that differentiated profile, that I spoke to later, that we think is especially important given where the supply chain is.

依從性是一種未被滿足的需求，因此在 LAI 細分市場中肯定有容納兩名參與者的空間。我認為，我們看到，精神分裂症是另一個被診斷出的患者較少的領域，有多個參與者，並且有一個 40 億美元的市場有人參與。也就是說，根據我們所看到的動態和市場狀況，我們仍然相信 SUBLOCADE 提供的差異化形象。它非常適合美國市場，在美國市場，非法供應鏈已被合成阿片類藥物所取代，並以五年的HCP 患者經驗為後盾，並且它具有差異化的特徵，我稍後談到，我們認為這一點尤其重要，因為供應鏈在哪裡。

So we have -- even with competition, we have conviction behind our guidance for 2024. Our peak revenue guidance of greater than $1.5 billion, and then, of course, our interim guidance where we expect to exit 2025 at a $1 billion run rate.

因此，即使存在競爭，我們也對 2024 年的指導充滿信心。我們的高峰收入指導超過 15 億美元，當然還有我們的中期指導，我們預計到 2025 年將以 10 億美元的運行速度退出。

Great. Thanks again.

偉大的。再次感謝。

Thank you, Carl.

謝謝你，卡爾。

Max Herrmann, Stifel.

馬克斯·赫爾曼，斯蒂菲爾。

Great. Thanks for taking my supplemental questions. Three if I may, two on R&D. Just wanted to understand the next steps, obviously, with AEF-0117 for cannabis use disorder. Obviously, going to get the data in the third quarter, and then, I guess, end-of-Phase 2 meeting with the FDA before the end of the year. Assuming it's positive, are you able at this point to have a view on what the Phase 3 would look like and what the timing would be? That is the first question.

偉大的。感謝您提出我的補充問題。如果可以的話，三個，兩個用來研發。顯然，只是想了解 AEF-0117 治療大麻使用障礙的後續步驟。顯然，我們將在第三季度獲得數據，然後，我想，將在年底前與 FDA 舉行第二階段會議。假設這是正面的，您現在是否能夠對第三階段的情況以及時間安排有一個看法？這是第一個問題。

Secondly, just on a bit more detail in terms of the proof-of-concept study for INDV-2000, the Orexin-1 antagonist, what is the Phase 2 trial design?

其次，就 Orexin-1 拮抗劑 INDV-2000 的概念驗證研究而言，更詳細一點，2 期試驗設計是什麼？

And then, finally, just trying to understand, it sounds like your underlying business, if I get it correctly, with stocking and the headwinds from the Change Healthcare, as well as the Medicaid disenrollment, that you are around 10% sort of growth quarter on quarter, which is in line with what your new patient, or patient start data suggested quarter-on-quarter growth in terms of patients on treatment. Is that what that's an indicator of as well, trying to understand the difference between dispensed units and new patients? Thank you.

最後，我想了解一下，如果我沒理解錯的話，考慮到庫存和醫療保健變革以及醫療補助計劃退出帶來的不利因素，這聽起來像是您的基礎業務，您的季度增長率約為10 %季度成長，這與您的新患者或患者開始數據顯示的接受治療患者的季度環比增長一致。這也是試圖了解配發單位和新患者之間差異的指標嗎？謝謝。

Maybe I will start with the third question, and then I will hand over to Christian, who is here to handle those two R&D.

也許我會從第三個問題開始，然後我會交給克里斯蒂安，他在這裡負責這兩個研發。

I think what we have tried to indicate is we do believe the one-off sort of impacts associated with these transitory items is mid to high single digits. When you look at the dispenses, we are at 4%. And we talked to the fact that historical planning and our planning had us in double digit sort of growth in the first quarter. So I think your interpretation is accurate, Max, that the underlying business we would expect, to be double-digit quarter-over-quarter growth. So thank you for that question.

我認為我們試圖表明的是，我們確實相信與這些暫時性項目相關的一次性影響是中等到高個位數。當你查看分配情況時，我們的比例是 4%。我們談到了這樣一個事實：歷史規劃和我們的規劃使我們在第一季實現了兩位數的成長。所以我認為你的解釋是準確的，麥克斯，我們預計基礎業務將實現兩位數的季度環比增長。謝謝你提出這個問題。

Christian, do you want to talk through AEF-0117 and the [Ox-1]?

Christian，你想談談 AEF-0117 和[Ox-1]？

Absolutely, Mark. So AEF-0117, as you mentioned, we are currently waiting to see the results of the Phase 2b trial. This is going to happen in the third quarter this year, after which, clearly, we will request an end-of-Phase 2 meeting with the FDA. We hope that the agency will grant us the meeting in the fourth quarter of this year.

當然，馬克。因此，正如您所提到的，AEF-0117 目前正在等待 2b 期試驗的結果。這將在今年第三季發生，顯然，之後我們將要求與 FDA 召開第二階段結束會議。我們希望該機構允許我們在今年第四季舉行會議。

This meeting, as you know, is going to be really critical for us to understand. First, the FDA's perspective on the Phase 2b data, because this is going to determine the type of Phase 3 trial that we may want to propose to the agency, but also clearly a major discussion as to the clinical endpoints for that pivotal Phase 3 trial, not only the primary endpoints but also the secondary endpoints.

如您所知，這次會議對於我們的理解非常重要。首先，FDA 對 2b 期數據的看法，因為這將決定我們可能想要向 FDA 提議的 3 期試驗的類型，但也顯然是關於該關鍵 3 期試驗的臨床終點的主要討論，不僅是主要終點，還包括次要終點。

So really, I cannot comment on the design of a Phase 3 trial at this stage, especially since I haven't seen the data. But again, that critical meeting with the FDA, hopefully before the end of the year. And then we will have to make a decision, as a corporation, as to whether or not we exercise the option and then move forward, to the remaining part of the clinical development plan.

所以說實話，我現階段無法對第三階段試驗的設計發表評論，特別是因為我還沒有看到數據。但同樣，與 FDA 的關鍵會議希望在今年年底前舉行。然後，作為一家公司，我們必須決定是否行使該選擇權，然後繼續進行臨床開發計劃的其餘部分。

The INDV-2000 clinical proof-of-concept design, I will not comment on the design per se. We submitted a protocol to the agency in the first quarter this year. We had a couple of back and forth with the agency to finalize the protocol. In a nutshell, basically, for a proof-of-concept, we are going to try to understand how we can transition patients from a buprenorphine initiation of treatment onto this completely new mechanism of action that, as you know, is a non-opioid-based medication for the maintenance of treatment of opioid use disorder. So more on this one as we initiate the trial the second quarter of 2024.

INDV-2000臨床概念驗證設計，我不會評論設計本身。我們在今年第一季向該機構提交了一份協議。我們與該機構進行了幾次來回討論，最終確定了協議。簡而言之，基本上，為了進行概念驗證，我們將嘗試了解如何將患者從丁丙諾啡起始治療轉變為這種全新的作用機制，如您所知，它是一種非鴉片類藥物用於維持阿片類藥物使用疾患治療的藥物。我們將於 2024 年第二季啟動試驗，對此進行更多介紹。

Great, thank you. I mean, how many -- are you able to say how many patients will be in the study?

太好了謝謝。我的意思是，您能說出有多少患者將參與這項研究嗎？

We will have about 330 patients in that clinical proof of concept.

我們將有大約 330 名患者參與此臨床概念驗證。

Great, thank you.

太好了謝謝。

Thanks, Max.

謝謝，馬克斯。

There are no further questions at this time. Speakers, please continue.

目前沒有其他問題。各位發言者，請繼續。

Thanks, Evan. With no more questions, this will conclude our Q1 results presentation. I'd like to thank everyone for their continued interest in Indivior, and we look forward to seeing everyone at the upcoming healthcare conferences. Thank you.

謝謝，埃文。沒有更多問題了，我們第一季的業績展示到此結束。我要感謝大家對 Indivior 的持續關注，我們期待在即將舉行的醫療保健會議上見到大家。謝謝。