Indivior PLC (INDV) 2023 Q4 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 that actual results may differ materially. We list the factors that may cause our results can be materially different than here on slide 2. We also may refer to non-GAAP measures, the reconciliations for which may be found in the appendix on to our presentation that has now posted on our website at indivior.com. I'll now turn the call over to Mark Crossley, our CEO.

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聲明，這些聲明可能會受到實際結果可能存在重大差異的風險和不確定性的影響。我們列出了可能導致我們的結果與投影片 2 中的結果有重大差異的因素。我們也可能會參考非公認會計準則措施，其調節可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。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. Thanks for joining us to discuss Indivior's fourth quarter and full year results. I'll begin with some opening remarks and a review of our growth strategy. Christian will then provide an update on our R&D priorities, following which Ryan will detail our financial performance and our 2024 guidance. Lastly, I'll provide some preliminary thoughts on the process we're initiating to consult on a potential primary US listing in the summer of 2024.

謝謝傑森，大家早安，下午好。感謝您加入我們討論 Indivior 第四季和全年業績。我將首先發表一些開場白並回顧我們的成長策略。然後 Christian 將提供我們研發重點的最新信息，隨後 Ryan 將詳細介紹我們的財務業績和 2024 年指導。最後，我將就我們正在就 2024 年夏季可能在美國首次上市進行諮詢的流程提供一些初步想法。

2023 was another year of strong execution and performance by our team. Led by SUBLOCADE, our total net revenue increased 21% to approximately $1.1 billion and adjusted operating profit increased 27% to $269 million. This was our third consecutive year of double-digit top line performance and even after absorbing the incremental cost of the opioid -- of the Opiant business and strategic growth investments behind SUBLOCADE, adjusted operating margins increased for the full year. We also made excellent progress against our strategic priorities to create a durable addiction focused franchise capable of delivering consistent value creation for shareholders.

2023 年是我們團隊強而有力的執行力和表現的另一年。在 SUBLOCADE 的帶動下，我們的總淨收入成長了 21%，達到約 11 億美元，調整後的營業利潤成長了 27%，達到 2.69 億美元。這是我們連續第三年實現兩位數的營收業績，即使在吸收了阿片類藥物的增量成本（Opiant 業務和SUBLOCADE 背後的戰略增長投資）後，全年調整後的營業利潤率仍然有所增加。我們還在我們的策略重點方面取得了出色的進展，以創建一個持久的專注於成癮的特許經營權，能夠為股東創造持續的價值。

I'll highlight the key milestones we achieved in 2023 in a moment. Looking ahead to 2024, we expect another year of strong net revenue growth led by SUBLOCADE. Taking the midpoint of our guidance, $850 million of SUBLOCADE net revenue implies 35% year-over-year growth, marking another major step towards our target of greater than $1.5 billion in peak net revenue. This in turn supports the Group's expectations of fiscal year 2024 of delivering 18% overall net revenue growth and approximately 300 basis points of operating margin expansion, again, both taken from the midpoints of our guidance range.

我稍後將重點介紹我們在 2023 年實現的關鍵里程碑。展望 2024 年，我們預計在 SUBLOCADE 的推動下，淨收入將再次強勁成長。以我們指引的中點計算，SUBLOCADE 淨收入 8.5 億美元意味著同比增長 35%，標誌著我們朝著超過 15 億美元峰值淨收入的目標又邁出了一大步。這反過來又支持了集團對 2024 財年實現 18% 整體淨收入成長和營業利潤率擴張約 300 個基點的預期，兩者均取自我們指導範圍的中點。

Importantly, both our performance in 2023 and our outlook for 2024 are in line with the medium-term profitable growth framework that we committed to at our Capital Markets Day in December 2022. Lastly, I wanted to take a moment on the earnings call to provide my perspective on the apparent disconnect between the market data available via Akebia and our results for SUBLOCADE.

重要的是，我們 2023 年的業績和 2024 年的前景都符合我們在 2022 年 12 月資本市場日承諾的中期獲利成長框架。最後，我想在財報電話會議上花點時間表達我對 Akebia 提供的市場數據與我們的 SUBLOCADE 結果之間明顯脫節的看法。

This phenomenon has occupied a significant amount of investor mine space and has been further reinforced with our fourth-quarter and fiscal year results shared today. As I mentioned last year and not dissimilar to some other specialty pharmacy products, it appears as though Akebia data does not capture our justice systems business, products to fill via specialty distributor via buy-and-bill, and, based on our estimates, appears to capture about 25% to 30% of the OHS business excluding justice systems.

這種現像已經佔據了投資者的大量空間，並且在我們今天分享的第四季度和財年業績中得到了進一步強化。正如我去年提到的，與其他一些專業藥品產品沒有什麼不同，Akebia 數據似乎沒有捕獲我們的司法系統業務，通過購買和賬單通過專業經銷商填寫的產品，並且根據我們的估計，出現佔據約25 % 至30% 的OHS 業務（不包括司法系統）。

For that reason and has been the case since launch, I can only endorse that you measure SUBLOCADE's performance via results data that we provide at our quarterly earnings. Turning to slide 6, expanding on our strategic priorities, we delivered on a number of important milestones in 2023. These included growing SUBLOCADE approximately 54% year-over-year to $630 million, with a total number of SUBLOCADE patients reaching nearly 137,000 on a 12-month rolling basis, this as an increase of 66% year-over-year.

基於這個原因，自推出以來一直如此，我只能同意您透過我們在季度收益中提供的結果數據來衡量 SUBLOCADE 的績效。轉向投影片 6，擴展了我們的策略重點，我們在 2023 年實現了許多重要的里程碑。其中包括 SUBLOCADE 年成長約 54%，達到 6.3 億美元，以 12 個月滾動計算，SUBLOCADE 患者總數達到近 137,000 人，較去年同期成長 66%。

We diversified our revenue base and expanded treatment across the continuum of care through the acquisition of Opiant Pharmaceuticals and subsequently launched OPVEE, our differentiated overdose rescue treatment. Our ex-US business continued to contribute to our growth through new products, including over a 50% increase in net revenue from SUBLOCADE. We expanded our pipeline with two important opportunities targeting opioid use disorder. We took steps to secure our supply chain with an acquisition of a sterile manufacturing facility in the US to support SUBLOCADE's greater than $1.5 billion revenue goal.

透過收購 Opiant Pharmaceuticals，我們實現了收入基礎多元化，並在整個護理過程中擴大了治療範圍，隨後推出了 OPVEE，這是我們差異化的藥物過量救援治療方法。我們的美國以外業務繼續透過新產品為我們的成長做出貢獻，其中 SUBLOCADE 的淨收入增加了 50% 以上。我們透過兩個針對鴉片類藥物使用障礙的重要機會擴大了我們的產品線。我們採取措施確保我們的供應鏈安全，收購了美國的無菌生產設施，以支持 SUBLOCADE 超過 15 億美元的收入目標。

And also in terms of securing our future, we settled the antitrust multi-district litigation and continue to believe that the remaining legal matters are manageable. Our confidence in our future was reinforced by the initiation of $100 million share repurchase program last November. And finally, today's announcement that following our successful listing on NASDAQ last June, we'll be formally exploring making the US the primary trading venue for Indivior's shares while maintaining a standard listing in London.

此外，在確保我們的未來方面，我們解決了反壟斷跨地區訴訟，並繼續相信剩餘的法律事務是可控的。去年 11 月啟動的 1 億美元股票回購計畫增強了我們對未來的信心。最後，今天宣布，繼去年 6 月在納斯達克成功上市後，我們將正式探索將美國作為 Indivior 股票的主要交易場所，同時維持在倫敦的標準上市。

As we enter our 10th year as a public company, I want to briefly highlight the compelling fundamentals that support our business and how our team has successfully executed against this backdrop. First, the market in which we participate, broadly defined its substance use disorders is a terrible global crisis that shows no signs of abating. Looking at our highest value at stake market, the US continues to offer a substantial opportunity for growth and treatment penetration, driven by increased funding and access.

在我們進入上市公司第十個年頭之際，我想簡要地強調一下支持我們業務的令人信服的基本面，以及我們的團隊如何在這一背景下成功執行任務。首先，我們參與的市場，廣義定義其藥物濫用障礙是一場可怕的全球危機，而且沒有任何減弱的跡象。縱觀我們的最高價值市場，在資金和准入增加的推動下，美國繼續為成長和治療滲透提供大量機會。

Drilling down to Indivior, our business is demonstrating attractive levels of growth and profitability. We've built a stronger addiction focus franchise with tremendous growth potential. The Indivior of today is an attractive growth platform based on new and proprietary growth products with an expanded pipeline of exciting potential medicines. Consequently, we're confident in our ability to sustain and build on our position for the benefit of our patients and stakeholders over the long term.

深入到 Indivior，我們的業務正在展現出有吸引力的成長和獲利水準。我們已經建立了一個更強大的專注於成癮的特許經營權，具有巨大的成長潛力。今天的 Indivior 是一個有吸引力的成長平台，基於新的專有成長產品，並具有令人興奮的潛在藥物的擴展管道。因此，我們對維持和鞏固我們的地位的能力充滿信心，以長期造福我們的病人和利害關係人。

The tragic reality is that the needs of our patients have never been greater, given the evolution of the opioid epidemic and the incidence of substance use disorders more generally. Overdose deaths are continuing to reach new record levels. The US is now in the middle of the deadliest phase of the epidemic, fueled by the rise to prominence of powerful synthetic opioids, such as fentanyl.

悲慘的現實是，考慮到阿片類藥物流行的演變和物質使用障礙的普遍發生，我們患者的需求從未如此之大。服藥過量死亡人數持續創下新紀錄。由於芬太尼等強效合成鴉片類藥物的日益流行，美國目前正處於流行病最致命的階段。

The latest data from the CDC suggest the annual overdose deaths in the US are now provisionally reaching over 112,000 lives on a daily basis, this is equivalent to 300 deaths a day. What's also important to recognize is there continues to be a significant treatment gap with only a minority of patients diagnosed with OUD receiving medically assisted treatment. As shown on this slide, the estimates for the number of those affected and treated vary by source, but our view is that the higher end of these estimates is more reflective of the terrible reality.

美國疾病預防控制中心的最新數據顯示，美國每年因服藥過量死亡的人數目前暫時達到每天 112,000 人以上，相當於每天 300 人死亡。同樣重要的是要認識到治療差距仍然很大，只有少數被診斷為 OUD 的患者接受醫療輔助治療。如這張投影片所示，受影響和治療人數的估計因來源而異，但我們的觀點是，這些估計的較高端更能反映可怕的現實。

Indivior's OUD and overdose rescue treatment, SUBLOCADE and now OPVEE, place us uniquely at the forefront of this complex and evolving disease space. We think efficacy is the critical treatment attribute for patients, particularly given the high potency of synthetic opioids. And we strongly believe that the unique scientific evidence base for our products makes them true paradigm shifts in treatment.

Indivior 的 OUD 和過量救援治療、SUBLOCADE 和現在的 OPVEE，使我們在這一複雜且不斷發展的疾病領域中處於獨特的前沿。我們認為療效是患者的關鍵治療屬性，特別是考慮到合成鴉片類藥物的高效力。我們堅信，我們產品獨特的科學證據基礎使它們能夠真正改變治療範式。

Turning to Slide 9. To execute against this backdrop and reach more patients, we reconfigured our go-to-market strategy in 2020 to focus on organized health systems. This strategy has driven strong double-digit growth over the past three years, and the channel now accounts for 80% of SUBLOCADE volume. We continue to be make excellent progress against our three-phase growth strategy for SUBLOCADE in this channel, comprised of facility activation, HCP adoption, and ultimately treatment of more patients.

轉向幻燈片 9。為了在此背景下執行並惠及更多患者，我們在 2020 年重新配置了進入市場策略，將重點放在有組織的醫療系統上。這項策略在過去三年中推動了兩位數的強勁成長，該通路目前佔 SUBLOCADE 銷量的 80%。我們繼續在該管道中針對 SUBLOCADE 的三階段成長策略取得出色進展，包括設施活化、HCP 採用以及最終治療更多患者。

Furthermore, we're continuously refining and improving our ecosystem model to help prescribers and patients navigate the complexities and fragmented nature of the OUD treatment landscape. These efforts include building out our regional specialty pharmacy network in order to deliver better customer service to treatment providers as well as deploying new tools for prescribers and patients. As a result, we expect the organized health systems channel will continue to be SUBLOCADE's primary growth driver.

此外，我們不斷改進和改進我們的生態系統模型，以幫助處方者和患者應對 OUD 治療領域的複雜性和分散性。這些努力包括建立我們的區域專業藥房網絡，以便為治療提供者提供更好的客戶服務，以及為處方者和患者部署新工具。因此，我們預計有組織的醫療系統管道將繼續成為 SUBLOCADE 的主要成長動力。

A second important refinement to our go-to market strategy was to build out dedicated capabilities to target the OHS subchannel US justice systems. This is critical as it's estimated that over 60% of OUD patients pass through the justice system at some point in their journey. Furthermore, with the recognition that justice system patients are an underserved and high-risk patient group, the environment is improving with increasing access to treatment as well as increased funding availability.

我們進入市場策略的第二個重要改進是建立針對美國司法系統 OHS 子管道的專門能力。這一點至關重要，因為據估計，超過 60% 的 OUD 患者在其旅程中的某個時刻會通過司法系統。此外，隨著人們認識到司法系統患者是服務不足和高風險的患者群體，隨著治療機會的增加以及資金的增加，環境正在改善。

Following our investments since 2022, the justice system has become our fastest growing subchannel and now accounts for approximately 20% of SUBLOCADE's net revenue. With over 600 activated facilities out of 8,000 to 12,000, we believe this channel will continue to grow in importance in fighting the opioid and substance use disorder epidemic well into the future. Taken together, we believe we've created an unrivaled continuous care that will continue to meet and evolve with the needs of the majority of patients and treatment providers.

經過我們自 2022 年以來的投資，司法系統已成為我們成長最快的子管道，目前約佔 SUBLOCADE 淨收入的 20%。在 8,000 至 12,000 個設施中，有 600 多個已啟用，我們相信該管道在未來對抗鴉片類藥物和藥物濫用疾病流行方面將繼續變得越來越重要。總而言之，我們相信我們已經創造了無與倫比的持續護理，將繼續滿足大多數患者和治療提供者的需求並不斷發展。

As we look to 2024 and beyond, we've chosen to strategically resource SUBLOCADE in the US. With our third quarter results last year, we announced the decision to extend SUBLOCADE's reach into the retail channel, which represents an incremental revenue opportunity.

展望 2024 年及以後，我們選擇在美國為 SUBLOCADE 提供策略性資源。根據去年第三季的業績，我們宣布決定將 SUBLOCADE 的業務範圍擴展到零售通路，這代表著一個增量收入的機會。

This followed the removal of the Data 2000 waiver in December 2022, which is an important step to open up the potential alternate sites of care. We successfully trialed this approach through our relationship with Albertsons, the second largest supermarket chain in North America, the pilot clearly indicated the value to smaller prescribers for alternate sites of care, and our network now operates approximately 1,160 locations across 20 states. We look forward to creating a nationwide network with additional partners in the future.

在此之前，2022 年 12 月取消了 Data 2000 豁免，這是開放潛在替代照護地點的重要一步。我們透過與北美第二大連鎖超市Albertsons 的關係成功地嘗試了這種方法，該試點計畫清楚地表明了小型處方者替代護理地點的價值，我們的網路現在在20 個州運營著大約1,160 個地點。我們期待未來與更多合作夥伴建立全國性網路。

We've also made the decision to invest further in justice system team, building up on a strong performance and access achieved to date. And lastly, we see a clear opportunity to provide additional medical and scientific inquiry support to help advance OUD disease state awareness and to engage key opinion leaders and clinicians with a differentiated science behind SUBLOCADE. To do this, we increased the size of our medical science liaison team. I'm confident that these strategic growth investments are scalable and will help us accelerate our progress towards our peak net revenue aspiration of greater than $1.5 billion.

我們也決定進一步投資司法系統團隊，以迄今為止的強勁績效和准入為基礎。最後，我們看到了一個明顯的機會，可以提供額外的醫學和科學調查支持，以幫助提高 OUD 疾病狀態意識，並讓關鍵意見領袖和臨床醫生參與 SUBLOCADE 背後的差異化科學。為此，我們擴大了醫學聯絡團隊的規模。我相信這些策略性成長投資具有可擴展性，並將幫助我們加快實現超過 15 億美元的最高淨收入目標。

Moving from SUBLOCADE to our other proprietary growth opportunities, let me start with OPVEE, where I'm pleased to say that our launch is fully on track. We continue to believe that this product has the ideal profile to address the epidemic of overdoses cost by both natural and synthetic opioids. We have a multifaceted commercial strategy, which includes an approved experienced program for states that are allowed to trial OPVEE within their populations.

從SUBLOCADE 轉向我們其他專有的成長機會，讓我從OPVEE 開始，我很高興地說我們的發布已完全步入正軌。我們仍然相信，該產品具有解決天然和合成阿片類藥物過量成本流行問題的理想特性。我們有一個多方面的商業策略，其中包括為允許在其人口中試用 OPVEE 的州提供經批准的經驗豐富的計劃。

We're also leveraging our government affairs team to ensure that these state standing orders grants and emergency medical service protocols are updated to include OPVEE as an overdose rescue treatment, and we were pleased to have secured a 10-year contract with BARDA that is potentially worth approximately $110 million, including funding for Phase 4 clinical studies, a year one order of $8 million in revenue for 100,000 units and options for similar orders over an additional nine years.

我們還利用我們的政府事務團隊來確保這些州常規撥款和緊急醫療服務協議得到更新，以將OPVEE 作為藥物過量救援治療納入其中，我們很高興與BARDA 簽訂了一份10 年期合同，該合同有可能價值約 1.1 億美元，包括 4 期臨床研究的資金、第一年 100,000 件 800 萬美元收入的訂單以及未來九年類似訂單的選擇權。

Our 2024 guidance includes $20 million of net revenue from OPVEE at the midpoint, reflecting the early establishment phase for this important life-saving medicine, and we continue to expect peak net revenue in the range of $150 million to $250 million.

我們的 2024 年指引包括 OPVEE 的淨收入中點為 2000 萬美元，反映了這種重要的救生藥物的早期建立階段，我們仍然預計峰值淨收入在 1.5 億至 2.5 億美元之間。

Moving now to PERSERIS, it's fair to say that we did face some significant challenges in the last couple of quarters of 2023 as a result of competitive pressures from a well-funded new market entrant. We nevertheless continue to believe in the potential of the important medicine for schizophrenia based on its differentiated clinical profile and strong feedback we get from clinicians. Furthermore, since we expanded the field force nationally in 2022, we've seen increases in market coverage and penetration.

現在轉向 PERSERIS，可以公平地說，由於資金充足的新市場進入者帶來的競爭壓力，我們在 2023 年的最後幾季確實面臨一些重大挑戰。儘管如此，基於其獨特的臨床特徵和我們從臨床醫生那裡得到的強烈回饋，我們仍然相信這種治療精神分裂症的重要藥物的潛力。此外，自 2022 年我們在全國範圍內擴大現場人員以來，我們看到市場覆蓋範圍和滲透率有所增加。

Entering 2024, we believe the team is regaining share of voice across targeted prescribers and volumes at the start of the year are building on the growth achieved in the fourth quarter. As a consequence, our guidance for 2024 is for strong double-digit net revenue growth, as Ryan will detail later.

進入 2024 年，我們相信該團隊正在重新獲得目標處方者的話語權，並且年初的銷售將在第四季度實現的成長基礎上繼續發展。因此，我們對 2024 年的指導是實現強勁的兩位數淨收入成長，瑞安稍後將詳細介紹。

On my final slide, I just wanted to remind you of the key elements of the medium-term profitable growth framework that we provided in December 2022. As you've seen today, we delivered against us in fiscal year 2023 with 21% net revenue growth and over 100 basis points of adjusted operating margin expansion. And as we achieve this operating leverage while also acquiring and integrating the Opiant acquisitions, which is both strategically and financially attractive, albeit with dilution of $40 million in OpEx or 400 basis points in 2023. Our fiscal year 2024 guidance indicates another year of significant price egress towards meeting these medium-term goals.

在最後一張投影片中，我只是想提醒您我們在 2022 年 12 月提供的中期獲利成長框架的關鍵要素。正如您今天所看到的，我們在 2023 財年實現了 21% 的淨收入成長，調整後營業利潤率擴張超過 100 個基點。當我們實現這種營運槓桿的同時，也收購並整合了 Opiant 的收購，這在策略和財務上都具有吸引力，儘管到 2023 年營運支出將稀釋 4,000 萬美元或 400 個基點。我們的 2024 財年指導表明，為實現這些中期目標，價格又將大幅上漲。

With that, I'll hand over to Christian for his R&D review.

這樣，我將把研發審查交給克里斯蒂安。

Thank you, Mark, and good morning, good afternoon to everyone. As you can see over the last year, our pipeline has expanded with several projects expected to reach development milestones in 2024. You may also note that INDV-4002, the intranasal naltrexone product for alcohol use disorder that came with our acquisition of Opiant Pharmaceuticals last year, no longer appears in our pipeline. INDV-4002 fail to meet its primary endpoint in the [sneaker] Phase 2 study that had been initiated by Opiant. We have, therefore decided to discontinue its development and prioritize our most promising project.

謝謝你，馬克，大家早安，下午好。正如您在去年所看到的，我們的管道已經擴大，多個專案預計將在 2024 年達到開發里程碑。您可能還注意到，去年我們收購 Opiant Pharmaceuticals 時推出的用於治療酒精使用障礙的鼻內納曲酮產品 INDV-4002，已不再出現在我們的產品線中。INDV-4002 未能達到 Opiant 發起的 [sneaker] 第 2 期研究的主要終點。因此，我們決定停止其開發並優先考慮我們最有前途的項目。

Let me start with an update on our activities in the opioid use disorder and the opioid overdose rescue. Our support to SUBLOCADE is four-fold, first label updates with a focus on rapid induction and alternate injections body sites. We are currently planning for pre-approval submissions to the FDA in the third quarter of this year. We've estimated approval in the first quarter of 2025, if priority review is granted or third quarter 2025 under standard review.

首先讓我介紹一下我們在阿片類藥物使用障礙和阿片類藥物過量救援方面活動的最新情況。我們對 SUBLOCADE 的支援有四重，首次標籤更新，重點是快速誘導和交替注射身體部位。我們目前正計劃在今年第三季向 FDA 提交預核准申請。如果獲得優先審查，我們預計將在 2025 年第一季獲得批准，如果接受標準審查，則預計在 2025 年第三季獲得批准。

Second evidence generation and peer-reviewed publications, including additional Phase 4 studies, externally sponsored studies, and real-world evidence studies. Third, product optimization with the implementation of our oxygen absorber desiccant for room temperature and shelf-life extension in the US, Australia, and Canada, as well as additional regulatory submissions. And fourth, access expansion in most of the world.

第二次證據產生和同行評審出版物，包括額外的第 4 階段研究、外部資助的研究和真實世界的證據研究。第三，在美國、澳洲和加拿大實施我們的脫氧劑乾燥劑以實現室溫和延長保質期，以及提交其他監管文件，從而實現產品優化。第四，在世界大部分地區擴大訪問範圍。

Unfortunately, fentanyl use continues to rise across the US with now more than 90% of opioid overdose deaths involving fentanyl and other synthetic opioids. Synthetic opioids have a more rapid onset of action than, for example, morphine and heroin and delayed intervention can produce diffuse brain damage and cardiac arrest. Therefore, the ability to rapidly restore normal breathing has become essential for a successful overdose reversal.

不幸的是，美國各地芬太尼的使用持續增加，目前超過 90% 的鴉片類藥物過量死亡涉及芬太尼和其他合成鴉片類藥物。合成鴉片類藥物比嗎啡和海洛因等起效更快，延遲幹預可能會導致瀰漫性腦損傷和心臟驟停。因此，快速恢復正常呼吸的能力對於成功逆轉藥物過量至關重要。

We are currently supporting our intranasal nalmefene rescue medication, OPVEE, through a series of initiatives as follows. First, as we have previously disclosed, we have started our contract with the Biomedical Advanced Research and Development Authority, BARDA. The overall objective and scope of this contract is to further support the efficacy and safety of OPVEE in real world to expand access as a medical countermeasure in the event of the synthetic opioids mass casualty events.

我們目前正在透過以下一系列措施支持我們的鼻內納美芬救援藥物 OPVEE。首先，正如我們之前所揭露的，我們已經開始與生物醫學高級研究與發展局 (BARDA) 簽訂合約。該合約的總體目標和範圍是進一步支持 OPVEE 在現實世界中的有效性和安全性，以在發生合成阿片類藥物大規模傷亡事件時擴大其作為醫療對策的使用範圍。

Second, we started post-marketing requirements to these including pediatric studies as well as studies further characterizing the safety profile of DDM, which is the nasal absorption enhancer in OPVEE's formulation. Third, we are committed to conduct real-world evidence studies to help understand the clinical real-world utilization of [OPVEE] compared to Naloxone.

其次，我們開始對這些項目提出上市後要求，包括兒科研究以及進一步表徵 DDM 安全性的研究，DDM 是 OPVEE 配方中的鼻腔吸收促進劑。第三，我們致力於進行真實世界證據研究，以幫助了解 [OPVEE] 與納洛酮相比的臨床真實使用情況。

Fourth, we are conducting study to see FDA approval of a shelf-life extension from 28 to 36 months. Fifth, we have expanded our externally sponsored studies program independent medical education grants to cover opioid overdose rescue as we believe encouraging the scientific and clinical review and use of these medications will help with this crisis. And finally, we are preparing a series of peer-reviewed publications that are covering the pharmacokinetics and pharmacodynamics characteristics of OPVEE.

第四，我們正在進行研究，爭取 FDA 批准將保質期從 28 個月延長至 36 個月。第五，我們擴大了外部資助的研究計劃獨立醫學教育補助金，以涵蓋阿片類藥物過量救援，因為我們相信鼓勵對這些藥物進行科學和臨床審查和使用將有助於應對這場危機。最後，我們正在準備一系列同行評審出版物，涵蓋 OPVEE 的藥物動力學和藥效學特徵。

There are also two projects that are currently in clinical development for opioid use disorder. First is INDV-2000, our selective Orexin-1 receptor antagonist. On November third, last year, we had a successful end-of-Phase 1 meeting with the FDA and agreed upon major aspects of clinical and nonclinical safety, enabling progression to a Phase 2 clinical proof of concept, therefore our key objectives in 2024 are four-fold.

目前還有兩個針對阿片類藥物使用障礙的項目正在進行臨床開發。首先是 INDV-2000，我們的選擇性 Orexin-1 受體拮抗劑。去年11 月3 日，我們與FDA 成功舉行了第一階段結束會議，並就臨床和非臨床安全性的主要方面達成一致，從而能夠進展到第二階段臨床概念驗證，因此我們2024 年的主要目標是四倍。

First, we need to define the clinic study report for the multiple ascending dose study that we finished last year. Two, make sure the product is available to initiate the clinical Phase 2 proof-of-concept study. Three, initiated drug substance manufacturing campaign to supply future clinical Phase 3 studies. And four, select the contract development and manufacturing organization for manufacturing into commercial drug product.

首先，我們需要定義去年完成的多次劑量遞增研究的臨床研究報告。第二，確保該產品可用於啟動臨床 2 期概念驗證研究。第三是啟動原料藥生產活動，以供應未來的臨床3期研究。第四，選擇合約開發和生產組織來生產商業藥品。

The second project, INDV-6001 is the outcome of our acquisition of the exclusive global rights to develop, manufacture, and commercialize Alar Pharmaceuticals' portfolio of long-acting injectable formulations of buprenorphine, which includes its lead three-months injectable candidate ALA-1000, now INDV-6001.

第二個項目 INDV-6001 是我們獲得開發、生產和商業化 Alar Pharmaceuticals 長效丁丙諾啡注射製劑產品組合的全球獨家權利的成果，其中包括其領先的三個月注射候選藥物 ALA-1000 ，現為INDV-6001。

Our key objectives for 2024 are equally four-fold. First, complete the technical transfer from Alar to Indivior. Two, optimize the drug substance and drug product manufacturing to support future clinical Phase 3 studies. Three, initiate multiple dose pharmacokinetic study to support future clinical Phase 3 studies. And four, initiate developmental and reproductive toxicology studies.

我們 2024 年的主要目標同樣有四個。首先，完成從Alar到Indivior的技術轉移。二是優化原料藥和製劑生產，支持未來的臨床3期研究。三、啟動多劑量藥物動力學研究，支持未來的臨床3期研究。第四，啟動發育和生殖毒理學研究。

Let me now talk briefly about our contribution to alcohol use disorder treatments. And as you can see, among the 137.4 million current alcohol users aged 12 grew in the US, almost 30 million people had a past-year alcohol use disorder and unfortunately, only 2.1% or a little bit more than 600,000 people received medication-assisted treatment in the past year. Although several medications have been approved for the treatment of alcohol use disorder, they have limitations in terms of efficacy and safety.

現在讓我簡單談談我們對酒精使用疾患治療的貢獻。正如您所看到的，在美國目前12 歲以下的1.374 億飲酒者中，近3000 萬人在過去一年中患有酒精使用障礙，不幸的是，只有2.1% 或略多於60 萬人接受了藥物輔助過去一年的治療情形。儘管多種藥物已被批准用於治療酒精使用障礙，但它們在療效和安全性方面有其限制。

Previous research, however, consistently indicated that GABA-B receptor agonist can significantly attenuate alcohol intake. Unfortunately, the use of full agonists is limited due to the pharmacokinetics profile and unfavorable safety. In contrast, positive allosteric modulators and the GABA-B has the potential to achieve mechanistic and therapeutic effects similar to GABA-B receptor agonists while avoiding their tolerance and the CTE issues. To date, all preclinical behavior results have invariably shown the efficacy of GABA-B positive allosteric modulators for alcohol use disorder treatment.

然而，先前的研究一致表明 GABA-B 受體激動劑可以顯著減少酒精攝取。不幸的是，由於藥物動力學特徵和不利的安全性，完全激動劑的使用受到限制。相較之下，正變構調節劑和 GABA-B 有可能實現與 GABA-B 受體激動劑類似的機制和治療效果，同時避免其耐受性和 CTE 問題。迄今為止，所有臨床前行為結果均顯示 GABA-B 正變構調節劑對酒精使用疾患治療的功效。

Our collaboration with Addex Therapeutics for the lead optimization of INDV-1000 has now resulted in the selection of two lead compounds for comprehensive in vitro and in vivo characterization. Extensive formulation work has also been initiated to optimize drug formulation over the anticipated dose range. We are aiming at a clinical candidate selection in the third quarter of this year and a selection will then be followed by starting investigational new drug application enabling studies as well as the manufacture of the drug substance for Phase 1 studies currently planned in 2025.

我們與 Addex Therapeutics 合作對 INDV-1000 先導化合物進行優化，現在已選擇兩種先導化合物進行全面的體外和體內表徵。廣泛的配方工作也已啟動，以在預期劑量範圍內優化藥物配方。我們的目標是在今年第三季進行臨床候選藥物選擇，然後將開始研究性新藥應用研究以及目前計劃於 2025 年進行 1 期研究的原料藥生產。

Let me conclude this presentation with an update on our activities to support cannabis use disorder. As you can see from the map, as of January 1 this year, about 38 states have legalized cannabis for either medical or recreational use. In the US, the latest data estimate to date almost 62 million people aged 12 or older were past year cannabis users and 19 million were diagnosed with cannabis use disorder in the past year. And we now know that a quadruple confluence of factors is leading to cannabis use disorder.

讓我以我們支持大麻使用障礙活動的最新情況來結束本次演講。從地圖上可以看出，截至今年 1 月 1 日，約有 38 個州已將大麻用於醫療或娛樂用途合法化。在美國，迄今為止的最新數據估計，去年有近 6,200 萬名 12 歲或以上的人吸食過大麻，去年有 1,900 萬人被診斷出患有大麻使用障礙。我們現在知道，四重因素共同導致了大麻使用障礙。

First, increasing prevalence of use. Two, increasing intensity of use in both frequency and quantity. Three, increasing THC content of cannabis products. And four, the age of cannabis use initiation. Our partnership with Aelis Farma includes, as you know, an exclusive option and license agreement for the global rights to AEF0117, which is Aelis' first-in-class synthetic signaling specific inhibitor engineered to modulate the cannabinoid 1 receptor. In clinical Phase 1 and Phase 2a studies, AEF0117 showed promising safety, tolerability, and efficacy signals in subjects with cannabis use disorder. These data were actually produced in the journal Nature Medicine in June last year.

首先，使用普及率不斷提高。二是增加使用頻率和數量的強度。三、增加大麻產品THC含量。第四，開始使用大麻的年齡。如您所知，我們與 Aelis Farma 的合作夥伴關係包括 AEF0117 全球權利的獨家選擇權和許可協議，AEF0117 是 Aelis 的一流合成信號特異性抑製劑，旨在調節大麻素 1 受體。在臨床 1 期和 2a 期研究中，AEF0117 在大麻使用障礙受試者中顯示出有希望的安全性、耐受性和有效性訊號。這些數據其實是去年六月發表在《自然醫學》雜誌上的。

Our objective this year is to continue to carry out major collaborative work with Aelis aimed at completing the Phase 2b trial and supporting additional clinical and nonclinical studies in preparation of late-stage clinical development. Aelis is expected to have the clinical Phase 2b Last Patient Last Visit in the second quarter of this year with an end-of-Phase 2 meeting with the FDA that we are trying to plan for the fourth quarter of this year.

我們今年的目標是繼續與 Aelis 進行重大合作工作，旨在完成 2b 期試驗並支持其他臨床和非臨床研究，為後期臨床開發做準備。Aelis 預計將在今年第二季進行臨床 2b 期最後一次患者最後一次就診，並與 FDA 舉行 2 期結束會議，我們正計劃在今年第四季舉行會議。

And finally, the development of INDV-5004, which is Drinabant, the cannabinoid 1 receptor antagonist for acute cannabinoid overdose is being pursued and funded by the National Center for Advancing Translational Sciences, NCATS, which is one of the NIH institutes to progress IND-enabling studies, including the optimization of the drug product formulation and completion of toxicology and safety studies.

最後，INDV-5004 的開發，即Drinabant，一種治療急性大麻素過量的大麻素1 受體拮抗劑，正在由國家轉化科學促進中心(NCATS) 進行和資助，該中心是NIH 推進IND 的機構之一。進行研究，包括優化藥品配方以及完成毒理學和安全性研究。

Thank you and let me hand it over to Ryan for the financials.

謝謝你，讓我把財務問題交給瑞安。

Thanks, Christian. Good morning and good afternoon to everyone. I'm pleased to report that we delivered a strong financial performance for Q4 and full year 2023. I plan to touch on some of the highlights before spending most of my time on our outlook for full year 2024. At a high level, we reported total net revenue growth of 21% in full year 2023, driven primarily by the 54% increase in SUBLOCADE net revenue.

謝謝，克里斯蒂安。大家早安，下午好。我很高興地報告，我們在第四季度和 2023 年全年實現了強勁的財務業績。在花大部分時間討論我們對 2024 年全年的展望之前，我計劃先談談一些要點。從較高層面來看，我們報告 2023 年全年總淨收入成長了 21%，這主要是由 SUBLOCADE 淨收入成長 54% 推動的。

Adjusted operating profit grew by 27% faster than our top line, despite the absorption of close to $40 million of Opiant and operating expenses and OPVEE launch expenses. From a liquidity standpoint, we exited the year with fee $451 million in gross cash and investments. Looking at our financial performance in more detail, starting with the top line, fourth quarter SUBLOCADE net revenue of $176 million increased 49% versus the prior year and 5% versus the prior quarter.

儘管吸收了近 4000 萬美元的 Opiant 和營運費用以及 OVEE 啟動費用，但調整後的營運利潤成長速度比我們的營收快 27%。從流動性的角度來看，我們今年結束時的現金和投資總額為 4.51 億美元。更詳細地審視我們的財務業績，從營收開始，第四季 SUBLOCADE 淨收入為 1.76 億美元，比上一年增長 49%，比上一季增長 5%。

US SUBLOCADE net revenue also increased 5% versus the prior quarter, with expenses growing slightly higher at 7%. During the quarter. There were modest increases in trade spend related to a higher mix of the Medicaid business. For the full year, SUBLOCADE net revenue reached $630 million, putting us at the top of our range that we increased with our H1 results.

US SUBLOCADE 淨收入也較上一季成長 5%，支出增幅略高，達 7%。本季期間。與醫療補助業務組合增加相關的貿易支出小幅成長。SUBLOCADE 全年淨收入達到 6.3 億美元，使我們在上半年業績成長的範圍內名列前茅。

Moving to PERSERIS, full year 2023 in Q4, net revenue of $42 million and $12 million dollars, respectively, both increased by 50% versus the comparable year ago periods. Although full year results did come in below our guidance. Overall growth in PERSERIS was primarily driven by the expansion of the sales team completed in late 2022.

轉向 PERSERIS，2023 年第四季全年淨收入分別為 4,200 萬美元和 1,200 萬美元，與去年同期相比均成長了 50%。儘管全年業績確實低於我們的指導。PERSERIS 的整體成長主要是由 2022 年底完成的銷售團隊擴張所推動的。

Turning to SUBOXONE Film, average share in the fourth quarter was approximately 18%, down roughly 2 points from full year 2022 average. As a reminder, we do not promote SUBOXONE Film in the US. Net revenue outside the US increased by 6% versus full year 2022 at actual and constant FX rates. We continue to see good growth in SUBUTEX prolonged release, the brand name for SUBLOCADE outside the US, which increased 52% and full year 2023 to $41 million while SUBOXONE Film also grew. These benefits were partially offset by pricing and volume pressure in the legacy tablet business.

至於 SUBOXONE Film，第四季的平均份額約為 18%，較 2022 年全年平均下降約 2 個百分點。提醒一下，我們不在美國推廣 SUBOXONE 薄膜。以實際和固定匯率計算，美國以外地區的淨收入較 2022 年全年增長 6%。我們繼續看到 SUBUTEX 長期發行（SUBLOCADE 在美國以外的品牌名稱）的良好增長，該品牌在 2023 年全年增長了 52%，達到 4100 萬美元，而 SUBOXONE Film 也實現了增長。這些優勢被傳統平板電腦業務的定價和銷售壓力部分抵消。

Moving down to P&L, our full year 2023 adjusted gross margin was 84%, up from 82% in the prior year. This increase reflects a mix benefit from SUBLOCADE, which was partially offset by less profitable government channels for SUBOXONE Film in the US and some inflationary impacts.

轉向損益表，我們 2023 年全年調整後毛利率為 84%，高於前一年的 82%。這一增長反映了 SUBOXONE Film 的混合效益，但部分被美國 SUBOXONE Film 的政府管道利潤較低和一些通膨影響所抵消。

Adjusted operating expenses were $649 million in full year 2023, up 22% year-over-year. Adjusted SG&A increased 18% and was driven by Opiant and OPVEE launch expenses targeted commercial growth investments behind SUBLOCADE and higher legal expenses. R&D expenses increased 47% in full year 2023. The significant step-up in R&D was driven by our ongoing Phase 4 SUBLOCADE studies and the progression of our early-stage pipeline.

2023 年全年調整後營運費用為 6.49 億美元，年增 22%。調整後的 SG&A 成長了 18%，這是由 Opiant 和 OPVEE 啟動費用、SUBLOCADE 背後的目標商業成長投資以及更高的法律費用推動的。2023年全年研發費用成長47%。研發的顯著進步是由我們正在進行的第 4 期 SUBLOCADE 研究和我們早期管道的進展所推動的。

Moving to adjusted operating profit. Full year 2023 adjusted operating profit of $269 million was up 27%, reflecting the strong top line growth, partially offset by commercial growth investments and the incremental expenses from Opiant, including the OPVEE launch costs. Adjusted net income also improved in full year 2023, reflecting similar dynamics as well as lower net finance expense, partially offset by slightly higher effective tax rate.

轉向調整後的營業利潤。2023 年全年調整後營業利潤為 2.69 億美元，成長 27%，反映出強勁的營收成長，但部分被商業成長投資和 Opiant 的增量支出（包括 OPVEE 啟動成本）所抵銷。2023 年全年調整後淨利潤也有所改善，反映出類似的動態以及較低的淨財務費用，但部分被略高的有效稅率所抵消。

Quickly touching on the balance sheet and our capital position, we ended full year 2023 with gross cash and investments of $451 million versus $991 million at the end of full year 2022. Strong cash flow from operations for the year was more than offset by legacy legal settlements -- legal settlement related items. I would note that $415 million in settlement payments for the direct purchasers and end payers is in escrow and reflected in other current assets pending final court approval. This is not included in the year-end $451 million figure.

快速回顧一下資產負債表和我們的資本狀況，2023 年全年末，我們的現金和投資總額為 4.51 億美元，而 2022 年末為 9.91 億美元。本年度強勁的營運現金流量被遺留的法律和解（法律和解相關項目）所抵銷。我要指出的是，直接購買者和最終付款人的 4.15 億美元和解付款已由第三方託管，並反映在其他流動資產中，等待法院最終批准。這還不包括在年終 4.51 億美元的數字中。

We have maintained our balanced approach to capital allocation with investment against each of our strategic priorities, including our third share repurchase program. As of February 16, as part of this repurchase program, we have purchased canceled 2.6 million shares for approximately $42 million.

我們保持了平衡的資本配置方式，根據我們的每個策略重點進行投資，包括我們的第三次股票回購計畫。截至 2 月 16 日，作為回購計畫的一部分，我們已以約 4,200 萬美元的價格購買了 260 萬股註銷股票。

Now turning to 2024 end guidance for the full year. As Mark noted, our overall financial guidance aligns to the attractive medium term growth profile that we laid out in our Capital Markets Day in December of 2022. Starting with total net revenue, we expect to deliver total net revenue in full year 2024 of $1.240 billion to $1.330 billion, primarily driven by SUBLOCADE and at the midpoint, this would represent growth of 18% versus the prior year. Our full year 2024 net revenue expectations for SUBLOCADE are $820 million to $880 million. The midpoint of this range suggests 35% year-over-year growth.

現在轉向 2024 年全年的最終指引。正如 Mark 所指出的那樣，我們的整體財務指引與我們在 2022 年 12 月的資本市場日中提出的有吸引力的中期增長狀況相符。從總淨收入開始，我們預計 2024 年全年總淨收入將達到 12.4 億美元至 13.3 億美元，這主要是由 SUBLOCADE 推動的，在中點，這將比上一年增長 18%。我們對 SUBLOCADE 2024 年全年淨收入的預期為 8.2 億至 8.8 億美元。該範圍的中點顯示同比增長 35%。

Similar to last year, SUBLOCADE's growth is expected to be driven by deepening penetration in the OHS channel and continued growth in adjustment system. We are still early in the retail channel expansion with our relationship with Albertsons but do expect to gain momentum there. Our SUBLOCADE guidance range contemplates a modest impact from the Medicaid reenrollment similar to full year 2023, and we will continue to monitor this dynamic during the year. Overall, we remain confident in meeting our net revenue target of $1 billion run rate exiting 2025 and our longer-term net revenue target of greater than $1.5 billion.

與去年類似，SUBLOCADE 的成長預計將受到 OHS 通路滲透率的加深和調整系統的持續成長的推動。由於我們與艾伯森的關係，我們仍處於零售通路擴張的早期階段，但確實希望在那裡獲得動力。我們的 SUBLOCADE 指引範圍預計醫療補助重新註冊會產生與 2023 年全年類似的適度影響，我們將在這一年中繼續監測這一動態。整體而言，我們仍有信心實現 2025 年運行率 10 億美元的淨收入目標以及超過 15 億美元的長期淨收入目標。

Our guidance for OPVEE is $15 million to $25 million, inclusive of approximately $8 million for 100,000 units as part of a multiyear agreement with BARDA. We expect sales to be back-half weighted to the heavy policy work continuing in the first half. For PERSERIS, our full year 2024 net revenue expectations are $55 million to $65 million, which represents 43% growth at the midpoint. As Mark mentioned, we remain confident that the PERSERIS' differentiated profile supports our peak net revenue expectations of $200 million to $300 million.

我們對 OPVEE 的指導價為 1500 萬至 2500 萬美元，其中包括作為與 BARDA 多年協議的一部分的約 800 萬美元購買 100,000 個單位。我們預計下半年銷售將受到上半年持續的繁重政策工作的影響。對於 PERSERIS，我們 2024 年全年淨收入預期為 5,500 萬至 6,500 萬美元，中間值成長 43%。正如 Mark 所提到的，我們仍然相信 PERSERIS 的差異化形象支持我們 2 億至 3 億美元的峰值淨收入預期。

With regards to US film, we continue to take a prudent stance on guidance. Our underlying assumption for full year 2024 reflects our overall observed historical share erosion of approximately one to two share points, together with some incremental share erosion from there our recently launched fourth generic. I would remind you that we did come to an agreement with Teva, which allows them to enter the market after January 31, 2025.

對於美國電影，我們繼續採取審慎的指導立場。我們對 2024 年全年的基本假設反映了我們總體觀察到的歷史份額侵蝕約一到兩個百分點，以及我們最近推出的第四種仿製藥的一些增量份額侵蝕。我想提醒您的是，我們確實與 Teva 達成協議，允許他們在 2025 年 1 月 31 日之後進入市場。

To round out total net revenue for the rest of the world business, we are anticipating modest growth and full year 2024 net revenue based on new product contributions more than offsetting legacy tablet competition and pricing actions. Looking at gross margin, we plan to deliver in the low to mid 80% range, this reflects the expected mix benefits from SUBLOCADE, partially offset by continued cost inflation. In the medium term, we remain confident that SUBLOCADE will support higher gross margins overall.

為了完善世界其他地區業務的總淨收入，我們預計基於新產品貢獻的 2024 年全年淨收入將適度增長，而不僅僅是抵消傳統平板電腦的競爭和定價行為。就毛利率而言，我們計劃在 80% 的低至中範圍內交付，這反映了 SUBLOCADE 的預期組合效益，部分被持續的成本通膨所抵消。從中期來看，我們仍然相信 SUBLOCADE 將支援更高的整體毛利率。

Turning to operating expenses, we continue to breakout R&D and SG&A to provide greater transparency in our guidance. Breaking down the components of operating expenses, we expect full year 2024 SG&A to be $575 million to $590 million and full year 2024 R&D to be between $120 million to $130 million. Our full year 2024 SG&A range at the midpoint reflects a 7% increase versus full year 2023's adjusted SG&A. This increase is expected to be driven by the annualized impact of the targeted commercial investments we have discussed, as well as the full year of Opiant and OPVEE launch expenses. I would also note that the rate of increase is expected to be significantly below the growth in our top line supporting our planned margin expansion.

談到營運費用，我們繼續突破研發和銷售、一般管理費用，以提高我們的指導透明度。依營運費用的組成部分，我們預計 2024 年全年銷售、管理及行政費用 (SG&A) 為 5.75 億至 5.9 億美元，2024 年全年研發費用為 1.2 億至 1.3 億美元。我們的 2024 年全年 SG&A 範圍的中點反映了與 2023 年全年調整後的 SG&A 相比增長了 7%。這一成長預計將受到我們討論過的目標商業投資的年化影響以及全年 Opiant 和 OPVEE 啟動費用的推動。我還要指出的是，預計成長率將大大低於支持我們計劃的利潤擴張的收入成長。

Turning to R&D, the midpoint of our guidance suggests an 18% increase, which reflects investments to advance early-stage assets as well as our Phase 4 studies for SUBLOCADE. In the medium term, we expect R&D to align more closely with the industry benchmarks of low double digits as a percentage of net revenue. Taking these elements together, we arrive at adjusted operating profit in the range of $330 million to $380 million, with material positive operating leverage at the midpoint of our guidance amounting to approximately 300 basis points.

談到研發，我們指導的中位數建議增加 18%，這反映了對推進早期資產的投資以及我們對 SUBLOCADE 的第四階段研究。從中期來看，我們預期研發佔淨收入的比例將更接近兩位數的產業基準。將這些因素綜合起來，我們得出調整後的營業利潤在 3.3 億美元至 3.8 億美元之間，在我們指導的中點處，實質的正營業槓桿約為 300 個基點。

I would note that we expect our tax rate to be in a low 20% range for full year 2024 due to the prior year's legal provisions. We do expect that we'll begin to return to the historical range of mid to high teens and early full year 2025.

我想指出的是，由於上一年的法律規定，我們預計 2024 年全年的稅率將處於 20% 的低水準。我們確實預計，到 2025 年全年，我們將開始回到中高十幾歲的歷史範圍。

Closing with our capital allocation framework, there is no change to our established approach. We continue to balance financial flexibility with investing for growth either organically or inorganically and returning capital to shareholders. We regularly evaluate these priorities together with the Board and have maintained close adherence to this framework. I will now turn the call back over to Mark.

最後我們的資本配置框架，我們的既定方法並沒有改變。我們持續在財務靈活性與有機或無機成長投資以及向股東返還資本之間取得平衡。我們定期與董事會一起評估這些優先事項，並始終嚴格遵守該框架。我現在將把電話轉回給馬克。

Thank you, Ryan. In closing, we announced today that the Group is exploring the potential to transition to a primary listing of its shares in the US. Consultations with shareholders will begin over the coming weeks. If these discussions are supportive, the Board intends to put forward a formal resolution to shareholders in the spring that would affect a US primary listing in the summer of 2024.

謝謝你，瑞安。最後，我們今天宣布，該集團正在探索其股票在美國首次上市的可能性。與股東的磋商將在未來幾週內開始。如果這些討論獲得支持，董事會打算在春季向股東提出一項正式決議，該決議將影響 2024 年夏季在美國的首次上市。

We, along with the Board believe that the US is Indivior's most logical primary trading venue based on our current and future business complexion and opportunities. As you see, the vast majority of our total net revenue is generated in the US. Further, the US is expected to increase of a proportion of the Group's total net revenue, driven by our proprietary products SUBLOCADE, OPVEE, and PERSERIS. The US opioid epidemic unfortunately only continues to worsen, and we believe Indivior's treatments are a huge part of the solution.

我們以及董事會相信，根據我們目前和未來的業務狀況和機遇，美國是 Indivior 最合理的主要交易地點。如您所見，我們總淨收入的絕大多數來自美國。此外，在我們的專有產品SUBLOCADE、OPVEE和PERSERIS的推動下，美國市場預計將增加集團總淨收入的比例。不幸的是，美國鴉片類藥物流行病只會繼續惡化，我們相信 Indivior 的治療方法是解決方案的重要組成部分。

We believe a primary listing in the US will further elevate awareness of the Group's profile in the US capital markets and will attract more US investors and US analyst coverage. Also, we believe there is value in US index inclusion over time. Finally, our US shareholder base continues to grow. We currently estimate that cumulatively almost 50% of Indivior shares are owned by US shareholders versus over 30% for UK shareholders.

我們相信，在美國首次上市將進一步提升集團在美國資本市場的知名度，並將吸引更多美國投資者和美國分析師的報告。此外，我們相信隨著時間的推移，納入美國指數也具有價值。最後，我們的美國股東基礎持續成長。我們目前估計，美國股東累計擁有近 50% 的 Indivior 股份，而英國股東則擁有超過 30% 的股份。

That said, I do want to be clear that our intention is not to leave the London market. We think it's important for our UK shareholders to continue to have a liquid trading venue that is convenient to them. Our organization is prepared to take this next step. We have investments in place for the required capabilities, including reporting, controls, and legal to make the transition successful. There will be no material incremental costs in affecting and maintaining a primary US listing.

也就是說，我確實想澄清，我們的意圖並不是離開倫敦市場。我們認為，對於我們的英國股東來說，繼續擁有一個對他們來說方便的流動性交易場所非常重要。我們的組織已準備好採取下一步行動。我們對所需的能力進行了投資，包括報告、控制和法律，以確保過渡成功。影響和維持在美國的主要上市不會產生實質的增量成本。

So in summary, the team has delivered strong underlying financial and operating results in fiscal year 2023, with significant progress against each of our strategic priorities. Fiscal year 2024 is shaping up to be an exciting year with our pipeline initiatives and our listing evaluation. Our overall 2024 financial guidance is strong and supports our plans to deliver material operating leverage. We look forward to communicating our progress as we go through the year.

總而言之，該團隊在 2023 財年實現了強勁的基礎財務和營運業績，在我們的每項策略重點方面都取得了重大進展。憑藉我們的管道計劃和上市評估，2024 財年將成為令人興奮的一年。我們的 2024 年整體財務指引強勁，支持我們提供實質營運槓桿的計畫。我們期待著在這一年中傳達我們的進展。

With that, I'll go ahead and open up the call to questions and answers.

接下來，我將開始進行問答。

Thank you. (Operator Instructions)

謝謝。（操作員說明）

Thibault Boutherin, Morgan Stanley.

蒂博·布瑟林，摩根士丹利。

Yes. Thank you very much. First question for OPVEE, please. So $15 million to $25 million guided of which $8 million from the BARDA contracts, just like to know if you could comment on the initial kind of launch dynamic outside of BARDA. Any commercial challenges you're facing adjusting on the market? Could give us more color on the strategy to work on that? And just generally more color on the situation on the ground would be helpful.

是的。非常感謝。第一個問題請教 OPVEE。因此，1500 萬至 2500 萬美元是指導資金，其中 800 萬美元來自 BARDA 合同，只是想知道您是否可以對 BARDA 之外的最初啟動動態發表評論。您在市場調整上面臨任何商業挑戰嗎？能否為我們提供更多關於這方面工作的策略？一般來說，對實際情況進行更多的描述會有所幫助。

Second question is business development. So you issued a point where you probably are well advanced in the integration of Opiants. Just wanted to kind of asses your appetite for this now. And in the specific therapeutic areas you're looking at your thinking has changed at all here. And maybe just last one on the asset sequential facilities, you could remind us the kind of impact on Canada and cash flow this year and the next couple of years. When will it break-even? And [do you have an exit here] would be helpful. Thank you.

第二個問題是業務發展。因此，您提出了一個觀點，表明您在 Opiants 的整合方面可能非常先進。只是想評估一下您現在對此的興趣。在你正在研究的特定治療領域，你的想法已經完全改變了。也許只是關於資產順序設施的最後一個，您可以提醒我們今年和未來幾年對加拿大和現金流的影響。什麼時候才能收支平衡？[這裡有出口嗎]會很有幫助。謝謝。

Thanks, Thibault. I appreciate the questions. And I think I'll answer the question on OPVEE and business development, and then I'll hand off to Ryan to talk through our new manufacturing site sort of implications. So let's talk about OPVEE, first off, I think we're exactly where we thought we'd be in this launch. As we talked last year, the initial stages are much more on the policy side to prep the market for a new rescue medication with a new active because most of the laws, the funding are all constructed based on the existing paradigm of treatment, which is Naloxone.

謝謝，蒂博。我很欣賞這些問題。我想我將回答有關 OPVEE 和業務開發的問題，然後我將交給 Ryan 討論我們新的製造基地的影響。首先，我們來談談 OPVEE，我認為我們在本次發布中正是達到了我們的預期。正如我們去年所說，初始階段更多的是在政策方面，為具有新活性成分的新救援藥物做好市場準備，因為大多數法律、資金都是基於現有的治療範式構建的，即納洛酮。

So the work's been going there. We have standing orders in place in 31 countries. We've been working with those that provide grants and funding to enable all FDA approved medications to be available for grants and we're working on protocols at the local level. So those efforts are in line with our expectations. I would also say that we've had some early adopters and have been very pleased with how the medication has performed in actual market versus the theoretical science that drove the actual acquisition.

所以工作一直在那裡進行。我們在 31 個國家有長期訂單。我們一直在與那些提供贈款和資金的機構合作，使所有 FDA 批准的藥物都能獲得贈款，並且我們正在地方層級制定協議。所以這些努力符合我們的期望。我還要說的是，我們有一些早期採用者，並且對藥物在實際市場中的表現與推動實際收購的理論科學的表現非常滿意。

So it's good to see those starting to really lined up that the hypothesis is coming through in early adoption. So very excited enough for OPVEE's potential, not only in 2024, but as a paradigm shift for helping those who've been subject to opioid overdose.

因此，很高興看到人們開始真正一致認為該假設正在早期採用中實現。我們對 OPVEE 的潛力感到非常興奮，不僅在 2024 年，而且作為幫助那些阿片類藥物過量的人的範式轉移。

On the business development side, listen, I think 2024 or 2023, excuse me, was a major step for us acquiring Opiant, acquiring a plant and bringing in a couple of new -- a couple of assets into our pipeline. As we look forward for our capital out location, we have a consistent framework moving forward but from a material M&A, we see 2024 more digesting what we have, so we don't anticipate material M&A in 2024. But we could, at any time, look to tuck in any early-stage assets of addiction that Christian finds to be good mechanisms of action.

在業務發展方面，聽著，我認為 2024 年或 2023 年，對不起，是我們收購 Opiant、收購一家工廠並將一些新資產引入我們的管道中的重要一步。當我們展望資本流出地點時，我們有一個一致的框架，但從重大併購來看，我們認為 2024 年將更多地消化我們所擁有的資產，因此我們預計 2024 年不會發生重大併購。但我們可以隨時尋求將克里斯蒂安認為是良好作用機制的成癮早期資產納入其中。

So we'll look to further sort of business development end of '24 and into 2025. So Ryan, could you speak to the manufacturing facility and its impacts?

因此，我們將著眼於 24 年底至 2025 年的進一步業務發展。Ryan，您能談談製造設施及其影響嗎？

So first, it is really exciting to bring this new facility under the on Indivior umbrella. We consider that a low-risk capital investment for $5 million to secure a long-term product supply. The plant is already operational. We have assumed some of the contracts they had. If the contracts are at a loss due to the way we've structured the deal that goes on the balance sheet. So what we're dealing with is, we've communicated we're going to have to invest about $40 million of CapEx over the next two or three years to get that facility prepared for SUBLOCADE.

首先，將這個新設施納入 on Indivior 旗下確實令人興奮。我們認為 500 萬美元的資本投資是低風險的，可以確保長期的產品供應。該工廠已經投入運作。我們承擔了他們擁有的一些合約。如果由於我們在資產負債表上建立交易的方式而導致合約出現虧損。因此，我們正在處理的是，我們已經表示，我們將在未來兩三年內投資約 4000 萬美元的資本支出，以使該設施為子定位做好準備。

But then and we've also communicated we may incur some modest margin impact over the next year or so. But the plan is to become productive and profitable within two years by the end of 2026, 2027, which at that point, we would see significant savings to the margins at that point. So overall, I'm very excited about this and all of these costs and on investments [that aren't] built in to our guidance that we provided.

但隨後我們也表示，我們可能會在未來一年左右的時間內對利潤率產生一些適度的影響。但計劃是在 2026 年和 2027 年底的兩年內實現生產力和盈利，屆時，我們將看到利潤率大幅節省。因此，總的來說，我對此以及所有這些成本和投資感到非常興奮，這些成本和投資並未納入我們提供的指導中。

Thanks, Ryan.

謝謝，瑞安。

Max Herrmann, Stifel.

馬克斯·赫爾曼，斯蒂菲爾。

Great. Thanks for taking my questions and congratulations on a strong end to 2023. I've got a number of questions, so please bear with me. Firstly, just in terms of SUBLOCADE and the potential longer term in terms of market penetration, clearly, you've now got another competing product, long-acting injectable on the market. I guess, where do you see the impediments now to that market share expanding may be beyond the sort of likes that we see with the analogs in the schizophrenia market and closer to where we see in our markets like Australia and then Finland, I wondered how in specifically prior authorization is being used by the insurers as an impediment for its uptake?

偉大的。感謝您回答我的問題，並祝賀 2023 年取得圓滿成功。我有很多問題，請耐心等待。首先，就 SUBLOCADE 和潛在的長期市場滲透而言，顯然，現在市場上有了另一種競爭產品，即長效注射劑。我想，您認為現在市場份額擴大的障礙可能超出了我們在精神分裂症市場中看到的類似情況，更接近我們在澳大利亞和芬蘭等市場中看到的情況，我想知道如何特別是事先授權是否被保險公司用作其採用的障礙？

We've been speaking to a number of clinicians, and that seems to be one of (inaudible) with before they can use SUBLOCADE or BRIXADI That's the first question.

我們一直在與許多臨床醫生交談，這似乎是他們可以使用 SUBLOCADE 或 BRIXADI 之前的（聽不清楚）之一，這是第一個問題。

Okay. So Max, listen, I think you're right in -- historically in the US when you're looking at the use of long-acting injectables, the adoption in Europe and other markets tends to be a bit higher, and that's just across most long-acting solutions. When I look to the future growth for SUBLOCADE and broader long-actings in opioid use disorder, I think there is such a huge unmet need in this space.

好的。所以麥克斯，聽著，我認為你是對的——歷史上在美國，當你考慮長效注射劑的使用時，歐洲和其他市場的採用率往往要高一些，而這只是跨越最長效的解決方案。當我展望 SUBLOCADE 和更廣泛的長效阿片類藥物使用障礙的未來成長時，我認為這個領域存在巨大的未滿足需求。

We have less than 2 and 10 patients in treatment. Adherence is the number one unmet need here. And you know, long-actings still have a very small share but are growing quite fast. And so plenty of room for multiple players in here and certainly were when you look at Indivior the true paradigm shift in treatment that SUBLOCADE offers with getting the therapeutic levels in four to eight hours maintaining those therapeutic hours -- those therapeutic levels to full 28 days with no on-top or booster dosing required and therapeutic levels that create blockade of the opioid receptors with 2 nanograms per milligram to 3 nanograms per milligram therapeutic levels of the 100 milligram dose and 5 nanograms per milligram to 6 nanograms per milligram of the 300 milligram maintenance dose that for us, we think perfectly suited for the synthetic opioids that are in the market.

我們有不到 2 至 10 名患者正在接受治療。堅持是這裡第一個未被滿足的需求。你知道，長效藥物所佔的份額仍然很小，但成長速度相當快。這裡有足夠的空間容納多個玩家，當然，當你看到Indivior 時，SUBLOCADE 提供的治療模式的真正轉變是在4 到8 小時內達到治療水平，維持這些治療時間- 這些治療水平達到完整的28天無需頂部或加強劑量，且治療水平可阻斷阿片類受體，100毫克劑量的治療水平為每毫克2納克至每毫克3納克，300毫克劑量的治療水平為每毫克5納克至每毫克6奈克對我們來說，維持劑量非常適合市面上的合成鴉片類藥物。

So we see continued strong growth as demonstrated with the guide we gave on SUBLOCADE this year, and certainly setting the stage for us to get to our greater than $1.5 billion point peak net revenue guidance that we have out there.

因此，我們看到了持續的強勁增長，正如我們今年在 SUBLOCADE 上提供的指南所證明的那樣，這無疑為我們實現超過 15 億美元的峰值淨收入指導奠定了基礎。

Right, thank you. In terms of SUBLOCADE obviously you've identified I highlighted that the IQVIA data is really not representative of the performance and its pretty small sample now of the total. We've seen, and you've talked about the seasonality of prescription trends, I wondered if you look back at the historical growth, you seem to see a stronger first half than a second half in terms of growth. Is that you'll expect again this year in 2024?

對了，謝謝。就子定位而言，顯然您已經確定我強調了 IQVIA 資料實際上並不能代表效能，而且它現在佔總數的樣本相當小。我們已經看到，您也談到了處方趨勢的季節性，我想知道您是否回顧歷史成長，您似乎會看到上半年的成長比下半年更強。今年 2024 年，您還會期待這樣的狀況嗎？

Yeah. Without getting into any sort of quarterly guidance, I think we have experienced over the last two years that there is a bit of seasonality in this sort of transformational sort of change to impact patients that's impacting growth disproportionally in the first half on a year -- on our quarter over quarter basis, where people are a little bit less motivated at the end of the year to take a transformational sort of change to engage with the long-acting. So what we would expect based on the last few years for that trend to continue.

是的。在沒有任何季度指導的情況下，我認為我們在過去兩年中經歷過，這種影響患者的轉型性變化存在一定的季節性，這對上半年的增長產生了不成比例的影響——在我們的季度環比基礎上，人們在年底採取變革性變革以實現長效的動力有點減弱。因此，根據過去幾年的情況，我們預計這種趨勢將持續下去。

And then two final questions, one is on the community kind of setting. Albertsons, currently, I think you talked about over 1,100 pharmacies now. What portion of scripts currently going through that channel and how do you see that channel responding to the OPVEE recent promotional efforts you've made there?

最後兩個問題，一個是關於社區類型的設定。Albertsons，目前，我想您談到了超過 1,100 家藥局。目前有哪些部分腳本正在通過該管道？您認為該管道對您最近在該管道所做的 OPVEE 推廣工作有何反應？

Yeah. Thanks for the question on that. I think it is an important as sort of evolution in the market as we seek to continue to normalize addiction treatment and make it available in new locations. And I think the removal of DATA 2000 allows that. As we talked, it is still incredibly early days here, Max, I mean, Albertsons just came online at the half year last year on and we are just now having the sales force expansion we talked about with the Q3 results, they're just now entering the field.

是的。感謝您提出這個問題。我認為這是市場的一種重要演變，因為我們尋求繼續規範成癮治療並在新的地點提供這種治療。我認為刪除 DATA 2000 可以實現這一點。正如我們所說，現在還處於令人難以置信的早期階段，麥克斯，我的意思是，艾伯森去年下半年剛剛上線，我們剛剛在第三季度的業績中談到了銷售隊伍的擴張，他們只是現在進入該領域。

I think the key for this year the future aspirations of what this could become. We see it as an incremental revenue opportunity that wasn't included in our initial greater than $1.5 billion net revenue guidance because we didn't have access to these independent physicians. And what we want to do is make it as seamless as possible, which means building off of Albertsons early move and finding other providers to create a national network that makes it so these independent doctors are able to prescribe SUBLOCADE for their patients.

我認為今年的關鍵是這可能成為未來的願望。我們將其視為一個增量收入機會，但並未包含在我們最初超過 15 億美元的淨收入指引中，因為我們無法接觸到這些獨立醫生。我們想要做的是使其盡可能無縫，這意味著以艾伯森的早期舉措為基礎，尋找其他提供者來創建一個全國性網絡，使這些獨立醫生能夠為他們的患者開出SUBLOCADE 處方。

So this is going to be quarters before we see material growth in the sector, but we think it will certainly help these patients and it is incremental revenue.

因此，我們需要幾個季度才能看到該行業的實質成長，但我們認為這肯定會對這些患者有所幫助，並帶來增量收入。

And then final question, just to give a kind of cool one out, some discussion of litigation. Where do you see that the current situation is in terms of the movement there obviously post the major settlements that you made last year, in particular focus perhaps on the way you see the tooth decay, MDL, and how you view the recent settlements on, let's say, by Hikma and others with regards to the opioid pain MDL.

最後一個問題，只是為了給一個很酷的問題，一些關於訴訟的討論。您在哪裡看到目前的情況是在運動方面，那裡顯然發布了您去年做出的主要和解，特別關注您如何看待蛀牙，MDL，以及您如何看待最近的和解，比方說，Hikma 和其他人關於阿片類藥物止痛MDL 的研究。

Yeah, thanks for the questions there, Max. And listen, we are pleased with the settlement of the antitrust MDL, and we expect that to become final within the fairness hearing happens in front of the judge who, as everyone knows, acted as the mediator in this case, so we expect that to occur. When it comes to the rest of our litigation, obviously, we believe that these items are quite manageable. We do highlight that this tooth loss claims, which initiated last year and we disclosed have now become an MDL, but it's still incredibly early days in that litigation.

是的，謝謝你的提問，麥克斯。聽著，我們對反壟斷 MDL 的和解感到高興，我們希望在公平聽證會中成為最終結果，眾所周知，法官在本案中擔任調解員，所以我們希望發生。顯然，當談到我們的其餘訴訟時，我們相信這些項目是相當容易管理的。我們確實強調，去年發起的牙齒缺失索賠現已成為 MDL，但該訴訟仍處於令人難以置信的早期階段。

And from an opioid MDL, again, we note that there are settlements going on but as we look to enter into whether it's resolution via a mediation or whether it's defending our claims in court because of the strong defenses we have, we'll continue to move forward in our efforts to resolve that moving forward.

從阿片類藥物 MDL 來看，我們再次注意到正在達成和解，但當我們考慮是否透過調解解決，或者是否因為我們擁有強有力的辯護而在法庭上捍衛我們的主張時，我們將繼續繼續努力解決這一問題。

Great. Thank you very much.

偉大的。非常感謝。

(Operator Instructions)

（操作員說明）

At this time, there are no further questions. I will now turn the call back over to Mark.

目前，沒有其他問題了。我現在將把電話轉回給馬克。

Thank you, Evan, and that officially closes our fiscal year 2023 results call. We appreciate the continued interest and support in Indivior, and we look forward to seeing everyone in the near future.

謝謝艾文，我們的 2023 財年業績電話會議就此正式結束。我們感謝大家對 Indivior 的持續關注和支持，並期待在不久的將來見到大家。