Indivior PLC (INDV) 2024 Q4 法說會逐字稿

Good day and thank you for standing by. Welcome to the Indivior PLC, full year results, 2024.

您好，感謝您的支持。歡迎來到 Indivior PLC，2024 年全年業績。

(Operator Instructions)

（操作員指令）

Please be advised that today's conference is being recorded.

請注意，今天的會議正在錄音。

I'd now like to hand the conference over to your host for today's call, Jason Thompson, Head of Investor Relations. Please go ahead.

現在，我想將會議交給今天電話會議的主持人、投資者關係主管傑森湯普森 (Jason Thompson)。請繼續。

Thanks, Sarah. 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 our presentation. These statements are based on current information and beliefs, and we disclaim any obligation to update them except where required by law. We also may refer to non-gap measures, the reconciliations for which may also be found in the appendix of our presentation that is now posted on our website at indivior.com. I'll now turn the call over to Mark Crossley, our CEO.

謝謝，莎拉。在我們開始之前，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的陳述，這些陳述受風險和不確定性的影響，實際結果可能存在重大差異。我們在簡報的第二張投影片中列出了可能導致結果出現重大差異的因素。這些聲明是基於當前的資訊和信念，除非法律要求，否則我們不承擔更新這些聲明的任何義務。我們也可以參考非差距指標，其對帳也可以在我們簡報的附錄中找到，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.

謝謝你，傑森，大家早安，下午好。感謝您的加入。

Joining me today on the call are Ryan Preblick, our Chief Financial Officer, Richard Simkin, our Chief Commercial Officer, and Dr. Christian Heidbreder, our Chief Scientific Officer.

今天與我一起參加電話會議的有我們的財務長 Ryan Preblick、我們的商務長 Richard Simkin 和我們的首席科學官 Christian Heidbreder 博士。

I'll quickly highlight our results, touch on guidance, and review our progress against strategic priorities. Then Richard will provide updates on the commercial strategies for our major products focusing on our efforts behind SUBLOCADE.

我將簡要介紹我們的成果、介紹指導意見並回顧我們根據策略重點所取得的進展。然後，Richard 將介紹我們主要產品的商業策略更新，重點介紹我們在 SUBLOCADE 背後的努力。

After that, Ryan will detail the financials and our full year 2025 outlook, and Christian's available if we have any pipeline related questions.

之後，Ryan 將詳細介紹財務狀況和我們 2025 年全年展望，如果我們有任何與管道相關的問題，可以隨時諮詢 Christian。

Looking at our results, I'm pleased we finished 2024 with positive momentum. We delivered 1/4 quarter performance that put our full year results above our latest guidance, and our primary growth engine SUBLOCADE ended the year with 20% net revenue growth overall.

回顧我們的業績，我很高興我們以積極的勢頭結束了 2024 年。我們實現了 1/4 季度的業績，使我們的全年業績高於我們最新的預期，而我們的主要成長引擎 SUBLOCADE 在年底實現了 20% 的整體淨收入成長。

We recognize that 2024 was a difficult period for the company and our investors.

我們認識到 2024 年對公司和我們的投資者來說都是一段艱難的時期。

As we previously highlighted, the performance of SUBLOCADE in 2024 was impacted by transitory items together with competition in the US long acting injectable category.

正如我們之前所強調的那樣，SUBLOCADE 在 2024 年的表現受到暫時性項目以及美國長效注射劑類別競爭的影響。

Furthermore, we took the decision mid-year to discontinue our schizophrenia treatment PERSERIS on profitability grounds.

此外，出於獲利原因，我們在年中決定停止精神分裂症治療藥物PERSERIS。

The result was that we were unable to deliver against our original expectations for 2024.

結果是我們無法實現 2024 年的最初預期。

Faced with this challenging backdrop, we took decisive actions in the back half of the year to fortify our position and support our long-term profitable growth ambitions.

面對這項充滿挑戰的背景，我們在下半年採取了果斷行動，鞏固了我們的地位並支持我們長期獲利成長的目標。

We narrowed our commercial and R&D pipeline focus to growing our long-standing leadership role in opioid use disorder.

我們將商業和研發重點縮小到加強我們在阿片類藥物使用障礙方面的長期領導地位。

In addition, we implemented cost reductions of over $100 million on an annual basis.

此外，我們每年也削減1億多美元的成本。

Together, these actions will provide us with the fuel to both reinvest behind SUBLOCADE and our two opioid use disorder phase 2 pipeline assets while also delivering more than $50 million of savings to the bottom line.

總之，這些舉措將為我們提供動力，讓我們能夠對 SUBLOCADE 和我們的兩項阿片類藥物使用障礙第 2 階段管道資產進行再投資，同時為企業節省超過 5000 萬美元的利潤。

Regarding the commercial investments we're making behind SUBLOCADE, we believe this is the right time to accelerate awareness of this important treatment among patients an HCPs, especially given the pending label updates that we expect will improve SUBLOCADE's competitive positioning through an HCP and patient experience.

關於我們對 SUBLOCADE 的商業投資，我們認為現在是加速患者和 HCP 對這一重要治療方法的認識的最佳時機，特別是考慮到即將進行的標籤更新，我們預計這將透過 HCP 和患者體驗提高 SUBLOCADE 的競爭地位。

Let me touch briefly on these proposed label changes which as a reminder covered rapid induction and alternate sites of injection on the body.

讓我簡單談談這些建議的標籤變化，提醒一下，這些變化涵蓋了快速誘導和身體上替代的注射部位。

We are confident in the strength of the data we provided, and the FDA informed us that there were no outstanding items for us to address. Consequently, we're optimistic the FDA will approve the label changes for SUBLOCADE in the coming weeks.

我們對所提供的數據的可靠性充滿信心，FDA 也告知我們沒有需要我們解決的未決問題。因此，我們樂觀地認為 FDA 將在未來幾週內批准 SUBLOCADE 的標籤變更。

In a moment, Richard will share some details on our commercial strategy to increase awareness of SUBLOCADE and medically assisted treatment more broadly.

稍後，理查德將分享一些有關我們的商業策略的細節，以更廣泛地提高人們對 SUBLOCADE 和醫療輔助治療的認識。

On top of our initiatives to streamline and refocus our business, another important development was a series of steps we took to further de-risk Indivior through ongoing resolution of certain legacy litigation.

除了精簡和重新調整業務的舉措之外，另一個重要進展是我們採取了一系列措施，透過持續解決某些遺留訴訟來進一步降低 Indivior 的風險。

We understand that these matters have created volatility in the past, but through our legal strategy, I believe we have put Indivior on much sounder footing.

我們理解這些問題在過去造成了不穩定，但透過我們的法律策略，我相信我們已經讓 Indivior 的基礎更加穩固。

Overall, I'm confident the actions that I've highlighted have placed Indivior in a stronger position to drive long-term profitable growth and shareholder value. In the near term, however, we expect a transition year for SUBOXONE Film and SUBLOCADE in 2025.

總的來說，我相信我所強調的行動將使 Indivior 處於更有利的地位來推動長期獲利成長和股東價值。然而，從短期來看，我們預計 2025 年將是 SUBOXONE Film 和 SUBLOCADE 的過渡年。

Notably, after five years of exceeding generic erosion analogs, net revenue from SUBOXONE Film is expected to decline sharply in 2025 due to intensified competitive generic pricing activity in the US, along with the potential for a [fifth generic] entrant.

值得注意的是，在連續五年超過仿製藥侵蝕類似物之後，由於美國仿製藥定價競爭加劇，以及可能出現 [第五種仿製藥] 進入者，SUBOXONE Film 的淨收入預計將在 2025 年大幅下降。

As a reminder, we do not promote SUBOXONE Film in the US.

提醒一下，我們不會在美國推廣 SUBOXONE Film。

For SUBLOCADE, we anticipate relatively unchanged net revenue at the midpoint of our guidance as competitive dynamics and near-term justice system funding challenges are expected to largely offset strong underlying long-acting injectable category growth and good growth in our organized health systems accounts.

對於 SUBLOCADE，我們預計在指導中期淨收入將相對保持不變，因為競爭動態和近期司法系統資金挑戰預計將在很大程度上抵消強勁的長效注射劑類別增長和我們有組織的醫療系統帳戶的良好增長。

In view of the expected reduction in film, net revenue, and profit, our 2025 guidance assumes a decline in total net revenue and adjusted operating profit versus 2024.

鑑於電影、淨收入和利潤的預期減少，我們對 2025 年的指引假設總淨收入和調整後的營業利潤將較 2024 年下降。

Drilling down a little deeper into our outlook for SUBLOCADE, we see two counteracting vectors in 2025. Our traditional base OHS business is expected to grow in the high single to low double digit range. This reflects a few factors, including overall LAI category growth, benefits from our past and current commercial investments to drive increased awareness, and improvement in our competitive position, assuming the pending label updates.

深入研究我們對 SUBLOCADE 的展望，我們發現 2025 年會出現兩個相互抵銷的趨勢。我們傳統的基礎職業健康與安全業務預計將實現高個位數至低兩位數的成長。這反映了一些因素，包括整體 LAI 類別的成長、我們過去和現在的商業投資帶來的好處，以提高知名度，以及提高我們的競爭地位（假設標籤更新即將進行）。

It also assumes that the market adjusts to two LAI competitors towards a steady state share split that is continuing to track with our cohort intelligence indicating an approximately 65-35 share split favoring SUBLOCADE amongst experienced dual LAI prescribers.

它還假設市場適應兩個 LAI 競爭對手，以實現穩定的份額分配，並且該分配將繼續追蹤我們的同類情報，表明在經驗豐富的雙重 LAI 處方者中，SUBLOCADE 的份額分配約為 65-35。

We expect that this outlook in the base business to be largely offset by challenges in the Justice channel due to funding gaps that are persisting in the 2025, as well as difficult choices, a few larger justice system accounts are having to make to treat more patients with constrained funding in the near term, resulting in long acting injectables losing position.

我們預計，基礎業務的這一前景將在很大程度上被司法管道的挑戰所抵消，原因是2025年持續存在的資金缺口以及一些較大的司法系統帳戶不得不做出的艱難選擇，以便在短期內以有限的資金治療更多的患者，從而導緻長效注射劑失去地位。

Richard will have more detail on our justice strategy, but I would simply emphasize that this near term justice system dynamic in no way diminishes the long term upside we see, and we expect growth again in 2026.

理查德將更詳細地介紹我們的司法策略，但我只想強調的是，短期的司法系統動態絲毫不會削弱我們所看到的長期優勢，我們預計 2026 年將再次實現成長。

We will not, however, allow this near term period of transition to take our attention away from the main driver of our business and shareholder value by focusing our efforts on opioid use disorder and growing the LAI category and emphasizing SUBLOCADE differentiated profile. We continue to expect to achieve SUBLOCADE's peak net revenue goal of greater than $1.5 billion.

然而，我們不會讓這段短期過渡期分散我們對業務和股東價值的主要驅動力的注意力，我們將集中精力於阿片類藥物使用障礙、擴大 LAI 類別並強調 SUBLOCADE 的差異化特徵。我們繼續期望實現 SUBLOCADE 超過 15 億美元的峰值淨收入目標。

Turning quickly to our report card on strategic priorities, which are now set against our narrowed focus, particularly as regards to R&D.

快速轉到我們關於策略重點的成績單，現在該成績單與我們縮小的關注範圍一致，特別是在研發方面。

Beginning with SUBLOCADE, we continue to see solid growth in the number of patients we're able to help in the past year. At the end of 2024, we had approximately 171,000 patients, a 25% increase compared to the end of 2023.

從 SUBLOCADE 開始，我們在過去一年中持續看到我們能夠幫助的患者數量穩步增長。截至 2024 年底，我們擁有約 171,000 名患者，與 2023 年底相比增加了 25%。

Recall reaching our peak net revenue goal contemplates treating approximately 270,000 patients, so continued good growth in 2024.

回想一下，達到我們的峰值淨收入目標需要治療約 27 萬名患者，因此 2024 年將繼續保持良好的成長。

And as I previously mentioned, our progress in helping patients delivered another overall solid net revenue performance for SUBLOCADE in 2024, growing 20% year over year despite the recent challenges.

正如我之前提到的，我們在幫助患者方面取得的進展為 SUBLOCADE 在 2024 年帶來了另一個整體穩健的淨收入表現，儘管最近面臨挑戰，但淨收入同比增長了 20%。

In terms of diversification, our efforts are focused on [OPVEE] in US and on driving net revenue of our new products SUBLOCADE and SUBOXONE Film in the rest of the world.

在多元化方面，我們的努力集中在美國的[OPVEE]以及在世界其他地區推動我們新產品SUBLOCADE和SUBOXONE Film的淨收入。

We made good progress in both areas. Richard will provide more detail on [opioid] in a moment, but we exited 2024 with 170 experience programs up and running with continued positive anecdotal feedback and growing potential for adoption.

我們在這兩個領域都取得了良好的進展。理查德稍後將提供有關 [阿片類藥物] 的更多詳細信息，但我們在 2024 年結束時已有 170 個體驗項目啟動並運行，並持續獲得積極的軼事反饋，並且採用的潛力越來越大。

Meanwhile, new products increased to more than 50% of the rest of world net revenue, mainly driven by SUBLOCADE.

同時，新產品佔全球其他地區淨收入的50%以上，主要得益於SUBLOCADE的推動。

In terms of pipeline and R&D, our focus is narrowed to our two assets for the treatment of opioid use disorder. The phase 2 studies for both have been committed to and funded, and development activities are on track with last patient, last visits for both studies expected in the fourth quarter this year.

在產品線和研發方面，我們的重點縮小到治療阿片類藥物使用障礙的兩項資產。兩項研究的第二階段研究均已投入並獲得了資金，開發活動正在按計劃進行，預計兩項研究的最後一位患者和最後一次就診將在今年第四季度進行。

On our last strategic priority, I'm pleased that we again made great strides in creating greater certainty for all our stakeholders. The two major items in 2024 were continuing to reduce enterprise risk with the settlements of certain legacy litigation and increased financial flexibility with a new debt facility totaling $400 million.

關於我們的最後一個策略重點，我很高興我們再次取得了巨大進步，為所有利害關係人創造了更大的確定性。2024 年的兩項主要事項是透過解決某些遺留訴訟繼續降低企業風險，並透過總額為 4 億美元的新債務融資增加財務靈活性。

More specifically on the completed legal settlements, we have now fully resolved the antitrust matters with the agreement we reached with the remaining parties in this legacy matter.

更具體地說，關於已完成的法律和解，我們現在已經與這一遺留問題的其他各方達成協議，完全解決了反壟斷問題。

I'm also pleased to confirm that in 2024 we continued our unwavering commitment and strong record of meeting our mandated integrity and compliance commitments. We're well on track to complete our obligations under the CIA this year.

我還很高興地確認，2024 年我們將繼續堅定不移地致力於履行我們規定的誠信和合規承諾，並保持良好的記錄。我們今年將順利完成中央情報局賦予我們的義務。

Finally, I want to highlight our capital allocation priorities during this transition period.

最後，我想強調一下我們在這個過渡時期的資本配置優先事項。

In 2025, we expect to generate positive underlying cash flows from operations and to maintain a strong cash position.

2025 年，我們預期經營活動將產生正的基礎現金流並維持強勁的現金狀況。

We do, however, need to be mindful of potential significant unwind of payables related to SUBOXONE Film, if share erodes at a rapid pace.

然而，我們確實需要注意，如果份額快速下滑，與 SUBOXONE Film 相關的應付款項可能會大幅減少。

As such, our near term capital allocation focuses on reinvesting in SUBLOCADE, completing the two clinical phase 2 studies, and maintaining our overall financial flexibility.

因此，我們近期的資本配置重點是對 SUBLOCADE 進行再投資、完成兩項臨床 2 期研究以及保持我們的整體財務靈活性。

As we move through this in the near term period, the board in partnership with management, will continue to actively review capital allocation, but at this time we are neither considering business development nor a return of capital to shareholders.

在短期內，董事會將與管理層合作，繼續積極審查資本配置，但目前我們既不考慮業務發展，也不考慮向股東返還資本。

With that, I'll now hand it over to Richard to provide a commercial overview.

說完這些，我現在將把話題交給理查德，讓他提供商業概述。

Thanks, Mark, and good morning and good afternoon, everyone.

謝謝，馬克，大家早安，下午好。

Just stepping back for a moment, I am pleased with the pioneering work we have done with SUBLOCADE to create the long acting injectable category for OUD.

稍作回顧，我很高興我們與 SUBLOCADE 合作完成了開創性的工作，為 OUD 創建了長效注射劑類別。

We've delivered strong growth across all the key metrics we track to assess our commercial effectiveness. Most importantly, we are treating more patients and reaching more providers than ever before. And while our efforts are delivering consistent progress towards our peak net revenue goal of greater than $1.5 billion we see an opportunity to accelerate this progress and fully unlock our potential through the additional investments we're announcing today.

我們在評估商業效益所追蹤的所有關鍵指標上都實現了強勁成長。最重要的是，我們治療的患者比以前更多，服務提供者也比以前更多。雖然我們的努力正在朝著超過 15 億美元的峰值淨收入目標不斷邁進，但我們也看到了透過今天宣布的額外投資來加速這一進程並充分釋放我們潛力的機會。

As Mark mentioned, 2025 will be a transition year for SUBLOCADE as the market fully adjusts to two players and as we confront near-term treatment funding challenges in the Justice Channel.

正如馬克所說，2025 年將是 SUBLOCADE 的過渡年，因為市場將完全適應兩家參與者，而且我們將面臨最近司法管道的治療資金挑戰。

Our belief over the long term remains that SUBLOCADE will continue to be the [LEI] choice in the US based on its differentiated profile, notably its efficacy across the entire monthly treatment interval.

我們始終相信，從長遠來看，SUBLOCADE 將繼續成為美國的 [LEI] 選擇，因為它具有差異化的特點，尤其是其在整個每月治療間隔內的療效。

We have been executing on a multi-year plan focused on infrastructure access, communicating the strength of our evidence base, and more recently tactically adjusting to the competition. We believe now is the time to fully leverage what we have built and learn through broadening the scope of our marketing to patients and HCPs.

我們一直在執行一項多年計劃，重點關注基礎設施接觸、傳達我們的證據基礎的優勢，以及最近針對競爭進行策略調整。我們相信，現在是時候充分利用我們已經建立和學習到的知識，透過擴大我們面向患者和 HCP 的營銷範圍。

The overriding goal of the investments we are making is to increase awareness of medication assisted treatment, specifically SUBLOCADE, and to ultimately deliver overall category expansion, higher net revenue, and increased market share.

我們投資的首要目標是提高人們對藥物輔助治療（特別是 SUBLOCADE）的認識，並最終實現整體類別的擴大、更高的淨收入和更大的市場份額。

Regarding the new market entrants, our co-prescriber cohort analysis continues to indicate that their share amongst experienced dual prescribers is stabilizing out at approximately 35%. Further, independent market research we conducted continues to indicate that efficacy is the most important consideration by prescribers when recommending an [LEI] treatment for OUD patients versus injection experience.

對於新進入市場的公司，我們的共同處方者群體分析繼續表明，他們在經驗豐富的雙重處方者中的份額穩定在 35% 左右。此外，我們進行的獨立市場研究繼續表明，與注射體驗相比，在為 OUD 患者推薦 [LEI] 治療時，療效是處方醫生最重要的考慮因素。

With these ongoing learnings, our increased investments behind SUBLOCADE are focused on compliantly accelerating HEP and patient awareness and activation, while at the same time building on our leadership positions in both organized health systems and the justice system.

透過這些持續的學習，我們增加了對 SUBLOCADE 的投資，重點是合規地加速 HEP 和患者的意識和激活，同時鞏固我們在有組織的衛生系統和司法系統中的領導地位。

Taking each in turn, with HCPs, we are focused on compliantly reinforcing SUBLOCADE efficacy through HCP education and by healthcare provider focused media. We also expect to improve our competitive position with the label changes Mark described earlier.

依序進行，與 HCP 一起，我們專注於透過 HCP 教育和以醫療保健提供者為中心的媒體，合規地加強 SUBLOCADE 的功效。我們也希望透過馬克之前描述的標籤變化來提高我們的競爭地位。

Regarding patients, our strategy here is to invest in media behind SUBLOCADE, including digital and television, covering a significant portion of SUBLOCADE's target patient and HEP base. Our market research shows that there is an approximate 80% pass rate when patients request SUBLOCADE. So, the goal with our media investments is to generate patient activation and request.

對於患者，我們的策略是投資 SUBLOCADE 背後的媒體，包括數位媒體和電視媒體，涵蓋 SUBLOCADE 目標患者和 HEP 群體的很大一部分。我們的市場調查顯示，患者請求 SUBLOCADE 的通過率約為 80%。因此，我們進行媒體投資的目標是激發患者的積極性和要求。

As you have heard, we expect to receive FDA approval for the proposed label changes, and if we receive a rapid induction on a label, HCPs will be able to treat patients with SUBLOCADE at the point when patients are most willing to be treated. With the only monthly LEI for rapid initiation, assuming FDA approval, we believe this label change will offer a real benefit for patients and treatment providers.

正如您所聽到的，我們期望 FDA 批准擬議的標籤變更，如果我們在標籤上獲得快速引導，HCP 將能夠在患者最願意接受治療時使用 SUBLOCADE 治療患者。如果獲得 FDA 批准，我們相信憑藉唯一的月度快速啟動 LEI，此標籤更改將為患者和治療提供者帶來真正的好處。

We are currently advertising in the highest priority territories that were chosen for having many OUD patients and having good access and distribution to fulfill increased SUBLOCADE requests. Lead indicators suggest our campaign is being impactful, with SUBLOCADE website traffic up significantly since launching the campaign.

目前，我們正在優先考慮的地區投放廣告，這些地區之所以被選中，是因為該地區擁有許多 OUD 患者，並且具有良好的訪問和分銷能力，可以滿足日益增長的 SUBLOCADE 請求。領先指標顯示我們的活動正在產生影響，自啟動活動以來，SUBLOCADE 網站的流量顯著增加。

Moving to the justice system.

轉向司法系統。

While short term factors are impacting our near-term net revenue expectations from this important channel, the long term opportunity here remains very attractive. Our challenge in the justice system is not the treatment itself. The HEP and patient experience is universally positive based on anecdotal feedback. Rather, the challenge we face is the volatility in funding, which in turn means our growth in this channel is unlikely to be linear in the near term.

雖然短期因素影響了我們對這個重要管道的近期淨收入預期，但這裡的長期機會仍然非常有吸引力。我們在司法系統中所面臨的挑戰並不是治療本身。根據軼事回饋，HEP 和患者的體驗普遍是正面的。相反，我們面臨的挑戰是資金的波動，這反過來意味著我們在這個管道的成長在短期內不太可能呈線性。

Our strategy to unlock the CGS opportunities is twofold. First, we will continue to activate new accounts and drive debt for prescribing. Think of this as the behind the wall opportunity that has generated a line share of SUBLOCADE justice system net revenue thus far.

我們釋放 CGS 機會的策略是雙重的。首先，我們將繼續啟動新帳戶並推動債務處方。可以將其視為幕後機遇，迄今為止，該機會已產生了 SUBLOCADE 司法系統淨收入的一定份額。

The second key element of our strategy is to unlock the opportunity for just these patients outside the walls where there are no funding issues as patients can maintain their medical coverage.

我們的策略的第二個關鍵要素是為這些城牆外的患者釋放機會，因為患者可以維持他們的醫療保險，所以不存在資金問題。

In short, while the business is expected to be the driver of SUBLOCADE in 2025, we continue to expect the justice system will be a tremendously important long-term growth option to the SUBLOCADE, and it is estimated over 60% of OUD patients touched the justice system at some point during their recovery. However, in the first half of this year, we expect the justice system to rebase and then to generate renewed growth in 2026.

簡而言之，雖然業務預計將成為 2025 年 SUBLOCADE 的驅動力，但我們仍然預計司法系統將成為 SUBLOCADE 極其重要的長期成長選擇，據估計，超過 60% 的 OUD 患者在康復期間的某個階段都接觸過司法系統。然而，我們預計今年上半年司法系統將重新調整，並在 2026 年實現新的成長。

Looking beyond the short term dynamics, it is vital to keep our eye on the opportunity we have to help patients with SUBLOCADE.

除了短期動態之外，我們必須密切注意幫助 SUBLOCADE 患者的機會。

The long term fundamentals remain compelling. First, in the US, there are approximately nine million people misusing opioids and only three million patients diagnosed with OUD. Despite the tremendous need, there are still only 1.2 people in BMAT treatment at any time or 1.8 million in a year. This reflects the fact that many patients are not aware of treatment. We have a significant opportunity to build awareness of any form of BMAT among patients and healthcare providers, as it is estimated that less than 15% of patients are aware of any brand name treatment.

長期基本面依然強勁。首先，在美國，約有 900 萬人濫用鴉片類藥物，而被診斷出患有 OUD 的患者只有 300 萬人。儘管需求龐大，但接受 BMAT 治療的人數始終只有 1.2 人，每年接受 BMAT 治療的人數也只有 180 萬人。這反映出許多患者並不了解治療的情況。我們有很好的機會在患者和醫療保健提供者中提高對任何形式的 BMAT 的認識，因為據估計，不到 15% 的患者知道任何品牌治療方法。

Through our investments, we aim to help with patient awareness that close this treatment GAAP.

透過我們的投資，我們旨在幫助患者提高意識，從而結束這種治療 GAAP。

The long acting injectable catering is also, we believe, still in the early days of market penetration. Our research suggests that up to 30% of OUD diagnosis patients would benefit from a long-acting injectable-like SUBLOCADE. Yet today long-acting injectables only command an approximate 8% share of patients seeking BMAT in the US. As such, a tremendous long term upside remains.

我們認為，長效注射餐飲也仍處於市場滲透的早期階段。我們的研究表明，多達 30% 的 OUD 診斷患者將受益於長效注射劑 SUBLOCADE。然而，目前長效注射劑僅占美國尋求 BMAT 的患者約 8%。因此，長期來看仍具有龐大的上漲空間。

Taken together, we continue to expect that we can meet our target of transforming the lives of 270,000 patients and beyond and in so doing deliver on the commercial potential of SUBLOCADE of greater than $1.5 billion of net revenue.

總的來說，我們繼續期望能夠實現改變 270,000 名甚至更多患者生活的目標，從而實現 SUBLOCADE 超過 15 億美元淨收入的商業潛力。

Now turning to [opioid]. At this point we're about sixteen months into the launch program. In truth, we thought we'd be further along the adoption curve based on [opioid's] profile and differentiation, specifically recognizing its label for effectiveness against synthetic opioids like fentanyl, which continue to be the responsible for the vast majority of opioid-related overdoses. At the last count, over 90% of opioid overdoses were caused by synthetic opioids like fentanyl.

現在轉向[鴉片類藥物]目前，我們的啟動計劃已經進行了十六個月左右。事實上，我們認為我們會根據[阿片類藥物的]特性和差異化在採用曲線上走得更遠，特別是認識到它對芬太尼等合成阿片類藥物的有效性，而芬太尼仍然是絕大多數阿片類藥物過量用藥的罪魁禍首。最新統計數據顯示，超過 90% 的鴉片類藥物過量用藥都是由芬太尼等合成鴉片類藥物引起的。

What's happening is that the harm reduction voice we're encountering is much louder and more influential than we expected, citing concerns about potential for precipitate withdrawal and the lack of real world evidence. This is slowing adoption at the State Department of Health level, which ultimately slows the ability for first line users like law enforcement to access [OPVEE], which we believe is needed as part of the treatment armamentarium.

實際情況是，我們聽到的減少危害的聲音比我們預期的要大得多，影響力也更大，人們擔心可能會突然撤回，而且缺乏現實世界的證據。這減慢了州衛生部門層面的採用速度，最終減慢了執法部門等第一線用戶訪問 [OPVEE] 的能力，而我們認為這是治療武器庫所必需的。

We are actively countering this unsubstantiated pushback with a combination of strategies.

我們正在採取多種策略積極應對這種毫無根據的反擊。

First, we are gathering real world evidence with our experience programs which are generating positive feedback and testimonials from users. Second, we continue to engage state and local policymakers and medical key decision makers around obvious value. And third, we have a robust evidence generation plan including real world and head to head studies versus naloxone, which we believe in time will provide the data to substantiate what we're hearing anecdotally from users.

首先，我們透過體驗計劃收集現實世界的證據，這些證據正在從使用者那裡獲得正面的回饋和推薦。其次，我們繼續圍繞明顯的價值與州和地方的政策制定者以及醫療關鍵決策者接觸。第三，我們有一個強有力的證據生成計劃，包括現實世界和針對納洛酮的面對面研究，我們相信隨著時間的推移，這些研究將提供數據來證實我們從用戶那裡聽到的軼事。

We are pleased to have fulfilled 2100,000 unit deliveries in 2024 as part of our ten year contract worth over $100 million with BARDA.

我們很高興能夠在 2024 年完成 2100,000 台設備的交付，這是我們與 BARDA 簽訂的價值超過 1 億美元的十年合約的一部分。

In 2025, we are planning for fulfillment of another BARDA order and importantly, progressive delivery of more meaningful commercial net revenue versus 2024.

2025 年，我們計劃完成另一項 BARDA 訂單，更重要的是，與 2024 年相比，逐步實現更有意義的商業淨收入。

As you see on the slide, we currently have 170 experience programs in place versus 10 at this time last year. We are expecting a number of these recipients to adopt [OPVEE] as their primary reversal agent and convert to customers with consistent order flow.

正如您在投影片上看到的，我們目前已實施 170 個體驗計劃，而去年同期只有 10 個。我們預計其中許多接收者將採用 [OPVEE] 作為其主要逆轉代理，並轉變為具有一致訂單流的客戶。

Our confidence in turning current experience program users into paying customers is based on the consistently positive feedback from those using the product in real world settings.

我們有信心將當前體驗程式的使用者轉變為付費客戶，這基於來自實際環境中使用產品的使用者一致的正面回饋。

Finally, in addition, we now have thirty-two states where standing orders have been updated to allow access to all overdose reversal agents, a key step to enabling purchase and distribution of OPVEE within the public interest market.

最後，此外，現在我們有 32 個州的常規訂單已經更新，允許使用所有過量逆轉劑，這是在公共利益市場內購買和分發 OPVEE 的關鍵一步。

Next steps in these states including in some cases being including protocols and being added to state protocols, so we recognize more work to be done, and that is the focus of the team.

這些州的下一步措施在某些情況下包括納入協議並添加到州協議中，因此我們認識到還有很多工作要做，這是團隊的重點。

Now let me now hand over to Ryan.

現在讓我把麥克風交給瑞安 (Ryan)。

Thanks Richard, and good morning and good afternoon to everyone.

謝謝理查德，祝大家早安，下午好。

As Mark discussed, despite a challenging year, we grew the top and bottom line in 2024 and significantly improved our financial flexibility. We also recalibrated our cost base to match our narrow strategic focus.

正如馬克所說，儘管這是充滿挑戰的一年，但我們在 2024 年實現了營收和淨利潤的成長，並顯著提高了財務靈活性。我們也重新調整了成本基礎，以適應我們狹窄的策略重點。

Looking at our financial performance in Fourth Quarter in more detail, starting with the top line. Overall, Fourth Quarter net revenue of $298 million was up 2% from last year, driven by SUBLOCADE.

從營收開始，更詳細地回顧我們第四季的財務表現。總體而言，在 SUBLOCADE 的推動下，第四季淨收入為 2.98 億美元，較去年同期成長 2%。

Fourth quarter total SUBLOCADE net revenue of $194 million, increased 10% versus the prior year and 2% versus the prior quarter.

第四季 SUBLOCADE 總淨收入為 1.94 億美元，較上年同期成長 10%，較上季成長 2%。

In the US, sequential growth in the quarter was aligned with suspense growth. The quarter included a modest benefit from the combined impact of stocking and trade spending leases in the mid single digit million dollar range, similar to the previous quarter. By channel, base dispensers grew in the low single digits on a sequential basis, offsetting CGS contraction, given the funding [Hedwidths] discussed.

在美國，本季的連續成長與懸念成長一致。本季受惠於庫存和貿易支出租賃的綜合影響，收益約為數百萬美元左右，與上一季類似。從通路來看，考慮到[Hedwidths]所討論的資金情況，基礎分銷商的銷量連續以個位數低位增長，抵消了 CGS 的收縮。

Of the net revenue for the Fourth Quarter was immaterial following the two BARDA orders in Quarter Three.

由於第三季的兩項 BARDA 命令，第四季度的淨收入並不重要。

For SUBOXONE Film, the average share of BMAT in the Fourth Quarter was approximately 15%, down approximately 3% points from the fourth quarter average in 2023.

對於 SUBOXONE Film，第四季 BMAT 的平均份額約為 15%，比 2023 年第四季的平均份額下降約 3%。

We exited 2024 slightly below 15% with increased competition, as Mark alluded to.

正如馬克所提到的，由於競爭加劇，我們在 2024 年結束時的市佔率略低於 15％。

For the rest of the world, Fourth Quarter 2024 net revenue was up 7% versus last year at actual exchange rates and 9% at constant exchange rates, driven by SUBLOCADE.

對於世界其他地區，在 SUBLOCADE 的推動下，2024 年第四季的淨收入按實際匯率計算較去年增長 7%，按固定匯率計算增長 9%。

But there's net revenue for the quarter was $9 million. The bulk of the net revenue, since we discontinued sales and marketing of the product has been supply orders to minimize patient disruption and trade spend releases.

但本季的淨收入為 900 萬美元。自從我們停止產品的銷售和行銷以來，淨收入的大部分都是供應訂單，以盡量減少患者中斷和貿易支出釋放。

Fourth Quarter adjusted gross margin was similar to the prior year period at 83% with a higher suffocated mix offset by cost inflation.

第四季調整後的毛利率與去年同期相似，為 83%，但成本上漲抵消了較高的抑制因素。

For operating expenses in Fourth Quarter, adjusted SG&A was up slightly versus the prior year, reflecting increased commercial investments and new financial reporting requirements partially offset by the discontinuation of Paris. Adjusted R&D was down 10% versus the prior year, reflecting reprioritization of pipeline activities to OUD.

就第四季度的營運費用而言，調整後的銷售、一般及行政費用較上年略有上升，這反映了商業投資的增加和新的財務報告要求，但被巴黎業務的停止部分抵消。調整後的研發費用較前一年下降了 10%，反映了管道活動優先順序向 OUD 的重新調整。

Overall, adjusted operating profit was flat in 2024 versus the prior year.

整體而言，2024 年調整後的營業利潤與前一年持平。

Moving to full year results for 2024. Overall net revenue increased 9%, driven by SUBLOCADE. Total SUBLOCADE net revenue reached $756 million up 20% year over year, putting a slightly above the range we discussed with our quarter three results.

轉向 2024 年全年業績。在 SUBLOCADE 的推動下，整體淨收入成長了 9%。SUBLOCADE 總淨收入達到 7.56 億美元，年增 20%，略高於我們在第三季業績中討論的範圍。

US film net revenue declined full year 2024 as expected, driven by continued share erosion.

由於市佔率持續下滑，美國電影 2024 年全年淨收入如預期下降。

Net revenue outside the US decreased by 1% versus full year 2023 at actual FX rates and increased a percent at constant FX rates.

以實際匯率計算，美國以外地區的淨收入較 2023 年全年下降 1%，以固定匯率計算，則成長 1%。

We continue to see good growth from SUBLOCADE outside the US with net revenue of 27% to $52 million while SUBOXONE Film also grew. These benefits were offset by erosion in the legacy tablet business.

我們繼續看到 SUBLOCADE 在美國以外地區實現良好成長，淨收入成長 27%，達到 5,200 萬美元，同時 SUBOXONE Film 也有所成長。但這些好處卻因傳統平板電腦業務的下滑而被抵銷。

Moving down the P&L, our full year 2024, just the gross margin was 83%, down slightly from 84% in the prior year with an improved product mix offset by cost inflation and less favorable manufacturing variances.

從損益表中可以看出，我們的 2024 年全年毛利率為 83%，略低於去年的 84%，產品組合的改善被成本上漲和製造差異的減弱所抵消。

Adjusted SG&A expenses were $576 million in full year 2024, up 6% versus full year 2023. The increases in 2024 primarily reflect sales and marketing investments and new financial reporting requirements. These items were partially offset by lower sales and marketing expenses from the discontinuation of PERSERIS.

2024 年全年調整後的銷售、一般及行政開支為 5.76 億美元，較 2023 年全年增長 6%。2024 年的成長主要反映銷售和行銷投資以及新的財務報告要求。這些項目被 PERSERIS 停產導致的銷售和行銷費用降低部分抵消。

For R&D, full year 2024 adjusted expenses decreased 3% to $103 million. The decrease reflects the prioritization of pipeline activities to OUD and related cost savings.

就研發而言，2024 年全年調整後支出下降 3% 至 1.03 億美元。減少反映了管道活動優先於 OUD 以及相關的成本節省。

Adjusted operating profit for four year 2024 grew by 16% to $312 million reflecting increased top line growth and lower overall expenses.

2024 年四年調整後營業利潤成長 16% 至 3.12 億美元，反映營收成長和整體費用下降。

Adjusting net income was essentially flat versus '23 with higher net finance expenses and a higher effective tax rate impacting results. Net finance expenses in full year 2024 primarily reflected decreased interest income on lower cash and investment balances.

調整後淨收入與23年相比基本持平，淨財務支出增加和有效稅率上升對業績產生了影響。2024 年全年淨財務支出主要反映現金和投資餘額減少導致的利息收入減少。

The higher effective tax rate in '24 was driven by the increase in the UK's effective tax rate and the non-deductibility of certain expenses during the year due to our US listing.

24年有效稅率的提高是由於英國有效稅率的提高，以及由於我們在美國上市導致當年某些費用不可扣除。

On a diluted per share basis, adjusting that income improved by 6% to [$56 per share], benefiting from a decline in weighted average share counts.

以攤薄每股收益計算，調整後收益提高 6% 至 [每股 56 美元]，受益於加權平均股數的下降。

Moving to the balance sheet in our capital position, we ended 2024 with gross cash and investments of $347 million versus $451 million at the end of '23.

轉到資本狀況的資產負債表，截至 2024 年底，我們的總現金和投資為 3.47 億美元，而 23 年底為 4.51 億美元。

Strong cash flow from operations for the year and our upsized debt refinance were more than offset by settlements of our legacy legal items and share buybacks.

全年經營活動產生的強勁現金流和我們增加的債務再融資被我們遺留法律項目的解決和股票回購所抵消。

During 2024, we bought back approximately 13.1 million shares for a total of $168 million and funded an additional $5 million to facilitate completion of the latest buyback.

2024 年，我們回購了約 1,310 萬股，總額為 1.68 億美元，並額外注資 500 萬美元以完成最新一次回購。

This $100 million dollar buyback, the fourth since 2021, concluded at the end of January 2025.

這次 1 億美元的回購是自 2021 年以來的第四次回購，於 2025 年 1 月底結束。

The debt refinance executed in November last year improved our financial flexibility, netting approximately $86 million of cash.

去年 11 月實施的債務再融資提高了我們的財務靈活性，淨賺約 8,600 萬美元現金。

We extended the maturity to 2030 and added a $50 million dollar revolver that remains unused.

我們將到期日延長至 2030 年，並增加了 5,000 萬美元尚未使用的循環信貸。

Now turning to guidance for 2025, which we are providing in US GAAP. Net revenue is equivalent in US GAAP and IFRS, and there are very minor differences in adjusted gross margin, expenses, and operating income between IFRS and US GAAP in full year 2024.

現在來談談我們按照美國 GAAP 提供的 2025 年指引。淨收入在美國 GAAP 和 IFRS 中是等值的，2024 年全年 IFRS 和美國 GAAP 之間的調整後毛利率、費用和營業收入差異很小。

We will be reporting a US GAAP going forward.

我們將在未來報告美國公認會計準則 (GAAP)。

For guidance and starting with total net revenue, we expect to deliver total net revenue in 2025 of $955 million to $1,025 million. At the midpoint, this guidance represents a decline in 17% versus the prior year, with film net revenue erosion accounting for 11% points of the total and the discontinuation of PERSERIS accounting for 3% points.

作為指導並從總淨收入開始，我們預計 2025 年的總淨收入將達到 9.55 億美元至 10.25 億美元。從中位數來看，該指引較上年下降了 17%，其中電影淨收入流失佔總收入的 11%，而 PERSERIS 的停止佔 3%。

Our full year 2025 net revenue expectation for SUBLOCADE is $725 million to $765 million. The midpoint of this range suggests a modest year on year decline of 1% for the reasons Mark and Richard provided.

我們對 SUBLOCADE 2025 年全年淨收入預期為 7.25 億美元至 7.65 億美元。正如馬克和理查德提供的原因，該範圍的中點表明同比下降幅度為 1%。

Turning to OPVEE, our net revenue guidance of $10 million to $15 million assumes approximately $8 million for a single BARDA order.

談到 OPVEE，我們的淨收入預期為 1000 萬至 1500 萬美元，假設單一 BARDA 訂單的收入約為 800 萬美元。

With regards to US SUBOXONE Film net revenue in 2005, we are taking a prudent stance on our net revenue expectations given the changing market dynamics. Our base assumption for the year reflects the recent intensification of competitive pricing dynamics by the generic providers, which is requiring greater rebating levels to maintain formulary access, as well as the impact of a potential fifth generic entrant.

對於 2005 年美國 SUBOXONE 薄膜的淨收入，考慮到不斷變化的市場動態，我們對淨收入預期採取了審慎的態度。我們對今年的基本假設反映了仿製藥供應商近期加劇的競爭性定價動態，這需要更高的回扣水平才能維持處方權，以及潛在的第五個仿製藥進入者的影響。

Given these dynamics, we expect US SUBOXONE Film net revenue to decline by approximately 55% versus 2024.

鑑於這些動態，我們預計美國 SUBOXONE Film 淨收入將較 2024 年下降約 55%。

To round out total net revenue for the rest of the world, we anticipate generally flat 2025 net revenue based on new product contributions offset by legacy tablet competition and pricing actions.

為了計算世界其他地區的淨收入總額，我們預計 2025 年的淨收入將基本持平，這得益於新產品的貢獻被傳統平板電腦的競爭和定價行動所抵消。

Looking at gross margins, we plan to deliver in the low to mid 80% range in 2025. This reflects expected mixed benefits from SUBLOCADE, partially offset by lower film margins. The Raleigh Manufacturing site acquired in late full year 2023 is on track for commercial production in full year 2026, and savings once fully ramped up in full year 2027.

從毛利率來看，我們計劃在 2025 年達到 80% 左右的毛利率。這反映了 SUBLOCADE 預期的混合效益，但被薄膜利潤率的下降部分抵消。於 2023 年底收購的羅利製造工廠預計將於 2026 年全年投入商業化生產，並在 2027 年全年實現成本節約。

We remain confident in the medium term that a higher mix of SUBLOCADE coupled with manufacturing savings will support higher gross margins.

從中期來看，我們仍然有信心，更高比例的 SUBLOCADE 加上製造成本的節省將支持更高的毛利率。

Turning to operating expense, we expect 2025 SG&A in a range of $525 million to $535 million and 2025 R&D of $85 million to $90 million.

談到營運費用，我們預計 2025 年銷售、一般及行政費用在 5.25 億美元至 5.35 億美元之間，2025 年研發費用在 8,500 萬美元至 9,000 萬美元之間。

Both guidance elements consider the annualization of PERSERIS savings, largely offset with inflation and the significant cost actions we took late last year and early this year as well. These additional actions exceeded $100 million and were primarily focused on G&A and our pipeline reprioritization efforts in R&D.

這兩項指導要素均考慮了 PERSERIS 節約的年化，很大程度上抵消了通貨膨脹以及我們在去年年底和今年年初採取的重大成本行動。這些額外行動超過 1 億美元，主要集中在 G&A 和研發方面的管道重新排序工作。

Overall, our total operating expenses are expected to be down more than $50 million year over year in 2025, including the significant allocation of funding to SUBLOCADE and our two phase 2 assets discussed earlier in the call.

總體而言，預計 2025 年我們的總營運費用將年減 5,000 多萬美元，其中包括向 SUBLOCADE 和我們在電話會議早些時候討論的兩個第二階段資產分配大量資金。

Together with the large step down in SUBOXONE Film net revenue, we arrive and adjust the operating profit in the range of $185 million to $225 million. While the midpoint reflects lower operating margins, we expect this profile to improve in the years ahead, given our scalable business and the unique confluence of circumstances in full year 2025. I also want to provide color and a couple of other line items which will impact net income.

加上 SUBOXONE Film 淨收入的大幅下降，我們將營業利潤調整至 1.85 億美元至 2.25 億美元之間。雖然中間點反映了較低的營業利潤率，但考慮到我們的可擴展業務和 2025 年全年的獨特情況匯合，我們預計未來幾年這一狀況將會改善。我還想提供顏色和其他一些會影響淨收入的項目。

Our expected adjusted tax range for 2025 will be between 22% and 25%. Before normalizing in the low 20s the following year.

我們預計 2025 年的調整後稅率範圍將在 22% 至 25% 之間。隔年才恢復正常，降至 20 多度。

Also, with our upsized debt facility of $400 million and expectations for lower cash investment income, we would expect our net finance expenses to be higher than 2024.

此外，由於我們的債務額度增加了 4 億美元，且預計現金投資收益將下降，我們預計淨財務支出將高於 2024 年。

In closing, 2025 represents a transitional year as we absorb the impact of the expected fall off in SUBOXONE Film net revenue, stabilize SUBLOCADE sales ahead of an expected return to strong growth, and gain traction with OPVEE.

最後，2025 年代表一個過渡年，因為我們將吸收 SUBOXONE Film 淨收入預期下降的影響，在預期恢復強勁增長之前穩定 SUBLOCADE 的銷售，並獲得 OPVEE 的青睞。

I am energized by the opportunities ahead and look forward to updating investors on our financial progress.

我對未來的機會充滿信心，並期待向投資者通報我們的財務進展。

With that, I will now turn the call over to Mark.

說完這些，我現在將電話轉給馬克。

Thank you, Ryan. Let me close by affirming that while 2025 looks set to be a year of transition, we will not allow this to take our attention away from the main driver of our business and shareholder value, namely SUBLOCADE.

謝謝你，瑞安。最後，我要確認，雖然 2025 年看起來將是過渡的一年，但我們不會因此而分散我們對業務和股東價值的主要驅動力，即 SUBLOCADE 的注意力。

The fundamentals of the opportunity we see to help patients remain fully intact, and as a leader with two decades of experience in developing and commercializing treatments that help OUD patients, we believe Indivior is well positioned to capture the leading share of the opportunity before us. By redoubling our efforts in opioid use disorder and with an improved competitive position, we continue to expect to achieve SUBLOCADE's peak net revenue goal of greater than $1.5 billion.

我們看到的機會的基本面是幫助患者保持完全健康，作為擁有二十年開發和商業化幫助 OUD 患者的治療方法的經驗的領導者，我們相信 Indivior 完全有能力抓住擺在我們面前的機遇的領先份額。透過在阿片類藥物使用障礙方面加倍努力並提高競爭地位，我們繼續期望實現 SUBLOCADE 超過 15 億美元的最高淨收入目標。

With that, I'll go ahead and open up the call for Q&A.

說完這些，我將繼續開始問答環節。

Thank you. If you would like to ask a question (Operator Instructions)

謝謝。如果你想問一個問題（操作員指令）

Thank you. We'll now take our first question.

謝謝。我們現在來回答第一個問題。

And this is from David Amsellem from Piper Sandler. Please go ahead.

這是來自 Piper Sandler 的 David Amsellem。請繼續。

Thanks. So, I just have a few first, I get your comments on the funding gap in the CJS, but you know how much, of the dynamics in CJS are related to the competitor. I didn't really hear you talk much about that, so can you talk about competition and the extent to which that's ahead wind in that channel. So that's number one.

謝謝。所以，我首先想問幾個問題，我了解你對 CJS 資金缺口的評論，但你知道 CJS 的動態有多少與競爭對手有關。我確實沒有聽到您談論太多這方面的問題，所以您能談談競爭以及該管道的領先程度嗎？這是第一點。

Then number two, I think you cited 35% in terms of share stabilization regarding [Bria], but I'm wondering out loud, can you talk about where you think your share. Of new starts is right now and where you think that's going to be in the context of a two player market as we get towards the latter part of the year.

那麼第二點，我認為您提到了 [Bria] 的份額穩定為 35%，但我很想知道，您能否談談您認為您的份額是多少。現在是新的開始，您認為隨著我們進入今年下半年，這將處於雙人市場的背景下。

I'm just trying to get a better sense of how you're doing with new starts and what is embedded in your guidance regarding share of new starts and then lastly on a quick one on SUBOXONE with the decline, what's your expectation not just about this year but longer term, are you expecting a sort of more commoditized outlook in terms of pricing of the product where you're going to see declines beyond this year? How do you think about that?

我只是想更好地了解您在新開藥品方面做得如何，以及您對新開藥品份額的指導意見中是如何闡述的，最後，關於 SUBOXONE 的下滑，您的預期是什麼，不僅是對今年，而且是長期，您是否預計產品定價會呈現更加商品化的前景，今年以後是否還會出現下滑？您對此有何看法？

Thank you.

謝謝。

So maybe what I'll do, David, and thanks for these questions, is I'll take the last question first and then I'll ask Ryan to talk about. The impact of CGS and where we see the competitor factored in versus the actual funding gaps, and then I'll ask Richard to talk about, the share stabilization, where we see the cohorts and where we see the current new starts and that dynamic. So, when we think about the pricing dynamic overall in this market, the pricing remains very constructive.

所以也許我會這樣做，大衛，感謝這些問題，我會先回答最後一個問題，然後我會請瑞安談談。CGS 的影響以及我們看到的競爭對手與實際資金缺口的關係，然後我會請理查德談談份額穩定、我們看到的群體以及我們看到的當前新起點和動態。因此，當我們考慮這個市場的整體定價動態時，定價仍然非常具有建設性。

PBMs are focused on full access. Both products and pricing remain resilient, after a little bit of pricing impact in the CGS last year in quarter three. We see stabilization, at this point, in criminal justice. So, we see, as we move forward, a good constructive sort of price environment, especially where the bulk of the businesses with the PBMs were focused on open access for two products.

PBM 專注於完全訪問。在去年第三季 CGS 的價格受到一點影響之後，產品和定價均保持彈性。我們現在看到刑事司法制度趨於穩定。因此，隨著我們不斷前進，我們看到了一個良好的建設性價格環境，尤其是當大部分 PBM 業務都專注於兩種產品的開放取用時。

Ryan, you want to talk about CGS and how we thought about the funding and the near term impacts of that at the start of the year versus the competitor?

瑞安，你想談談 CGS 嗎？

Yes, certainly Mark. So, hi David, good morning. So, the first thing I would say is when we look at CGS, and I think Richard alluded to us, the demand within the facilities is still strong. The feedback that we are receiving on SUBLOCADE has been positive and strong-- The treatment demand is there, but what we're seeing this year is the facilities are having to make decisions based on budgets. They have a fixed budget to treat a certain amount of patients. And so, at this point, when we're looking at the difference between Budget impact versus competition, it is primarily tied to these facilities having to make decisions on a budget versus any access impact we're having from competition. And what we're also seeing in terms of some phasing. We saw some of this occurring in the back half of 2024 and in our guide we did factor the continuation of this impact primarily in the first half with the projection of some growth return in the second half.

是的，當然了，馬克。嗨，大衛，早安。因此，我想說的第一件事是，當我們看 CGS 時，我認為理查德提到過，設施內的需求仍然強勁。我們收到的有關 SUBLOCADE 的回饋是積極且強烈的——治療需求是存在的，但我們今年看到的情況是，設施必須根據預算做出決策。他們有固定的預算來治療一定數量的病人。因此，此時，當我們研究預算影響與競爭之間的差異時，它主要與這些設施必須根據預算做出決策有關，而不是與競爭對我們產生的任何訪問影響有關。我們也看到了一些階段性的進展。我們看到其中一些情況發生在 2024 年下半年，在我們的指南中，我們確實考慮到這種影響將主要在上半年持續，並預測下半年將出現一些成長回報。

Thanks for that, Ryan, and maybe just one additional bit of color on that, David, is listen, while we see these funding constraints, we expect these to alleviate a bit through time. You're familiar with the Medicaid 1,115 waivers. There's 16 states that now have those approved, yet they have to operationalize those. Right now, they typically have a pharma budget, that they're able to just buy product from and now they'll have to bill out on a by-patient basis. We expect that operationalization of that to start occurring in 2026 and the further operationalization of abatement funds to help with those funding challenges.

謝謝你，Ryan，也許還有一點，David，聽著，雖然我們看到了這些資金限制，但我們預計這些限制會隨著時間的推移而有所緩解。您熟悉 Medicaid 1,115 豁免。現在已有 16 個州批准了這些計劃，但他們必須將其付諸實施。目前，他們通常有一個醫藥預算，他們可以從中購買產品，現在他們必須根據每個患者的情況開立帳單。我們預計該計畫將於 2026 年開始實施，減排資金也將進一步投入使用，以幫助解決這些資金挑戰。

Richard, can you talk about, the cohorts versus the new patient share?

理查德，您能談談同群患者與新患者的比例嗎？

Yes, certainly. So, thanks for the question. So, I think you're right on the cohorts, what we see at the moment is that they remain around 35%, as it's a differentiated concept, so we're pleased that we continue to see 65% for us. I think the other perspectives just to put out there. Matt mentioned about the label and the initiatives that we're expecting, we think that will also help in terms of competitiveness, specifically things like rapid initiation on the monthly and the alternative sites of injection. So, we're pleased about that. With regard to new starts, we see that around about that we have about 71% of new starts at the moment.

是的，當然。感謝您的提問。因此，我認為你對群體的看法是正確的，我們目前看到的是它們仍然佔 35% 左右，因為這是一個差異化的概念，所以我們很高興看到它們繼續佔 65%。我認為其他的觀點只是提出來而已。馬特提到了我們期待的標籤和舉措，我們認為這也有助於提高競爭力，特別是每月快速啟動和替代注射部位等方面。因此，我們對此感到高興。關於新開工，我們發現目前新開工率大約是 71%。

Yes, and just for further color, David, if we look back to quarter three. New patient starts we're at about 72, so they're about in the same spot as where they were quarter three, you're starting to see the market kind of level out and what we've built into our guidance is continued share, continued trial of the competitor product where we get to share in line with the cohorts.

是的，大衛，只是為了進一步了解情況，如果我們回顧一下第三季。目前新患者數量約為 72 名，因此他們與第三季度的情況大致相同，您開始看到市場趨於平穩，而我們在指導中考慮到的是繼續擴大份額，繼續試用競爭對手的產品，以便我們與同類產品保持一致的份額。

Okay, thank you.

好的，謝謝。

Thank you. Well, I'll take the next question.

謝謝。好吧，我來回答下一個問題。

This is from Brandon Folkes from Rodman & Renshaw. Please go ahead.

這是來自 Rodman & Renshaw 的 Brandon Folkes 的。請繼續。

Hi, thanks for taking my question. Maybe I'll just follow up on first on the prior one. Is the 71% new start, is that across both the monthly and the weekly, or is that just a sort of monthly new start?

你好，謝謝你回答我的問題。或許我只是會先跟進前一個問題。71% 是新開始，是涵蓋月度和每週嗎，還是只是一種每月新開始？

What we do is we equalize the weekly, so it's across both weekly and monthly. It'll be a total LEI look.

我們所做的是平衡每週的數據，這樣它就涵蓋了每周和每月的數據。這將是完全的 LEI 外觀。

Okay, and then just kind of staying on the weekly, how much of an advantage is the weekly dosing in practice when you're speaking to prescribers, we talked about efficacy being the number one prescribing decision.

好的，然後就繼續每週服用，當您與處方人員交談時，每週服用藥物在實踐中有多大優勢，我們討論了功效是首要的處方決定。

I'd imagine prescriber sees SUBOXONE, Brixadi and as efficacious, but granted, the differentiation really comes on the monthly. So, on that weekly, how should we think about when a prescriber is putting patients on weekly? Do they like it? Do they like, the higher touch point initially and then Following on from that, do you think you can gain those weekly patients back when they, if or when they decide to go on to a monthly given the sort of better coverage that SUBLOCADE has on a month?

我認為開處方者會認為 SUBOXONE、Brixadi 和同樣有效，但事實上，差異確實在於每月一次。那麼，在每週一次的治療中，當開處方的醫生為患者安排每週一次的治療時，我們該如何思考呢？他們喜歡它嗎？他們最初是否喜歡更高的接觸點，然後接下來，考慮到 SUBLOCADE 在一個月內提供的更好的覆蓋範圍，您是否認為當他們決定轉到每月治療時，您是否可以重新獲得那些每周治療的患者？

So, I think maybe how I'd answer it is first of all I think coming back to, the need, so what we see is efficacy is the key need in the marketplace over flexibility or dosing. So, I think number one thing when you're looking to treat patients is Do you have the right product for that patient that will cover them for the entire dosing period? So, I think those are the key things that HCPs are looking for with regard to things like Matt mentioned the label claims again, if you think about it, the ability to be able to move someone directly onto a monthly, I think is going to be a real good competitive point that we'll have the only able to do that.

因此，我認為也許我的回答首先是回到需求上，所以我們看到的是功效是市場對靈活性或劑量的關鍵需求。因此，我認為，當您尋求治療患者時，最重要的事情是您是否有適合該患者的產品可以覆蓋他們的整個給藥期？因此，我認為這些是 HCP 所尋找的關鍵事物，就 Matt 再次提到的標籤聲明而言，如果你仔細想想，能夠將某人直接轉移到月度的能力，我認為這將是一個真正良好的競爭點，我們只有能夠做到這一點。

I think the other point. That we need to accept is sometimes the weekly is used as induction initiation for Brixadi. Actually, if you look at the numbers, that's been considerably coming down in terms of their split of weekly to monthly over since their launch. So, you know we remain committed and convinced that the monthly is the right optimum dosing frequency as you see with take home doses on the orals, and I think. With the rapid initiation, if we get the label approved, I think that will be, obviously a great competitive point for us.

我認為是另一點。我們需要接受的是，有時每週都會被用作 Brixadi 的入職啟蒙。實際上，如果你看一下數字，你會發現自從推出以來，每週與每月的比例已經大大下降。因此，您知道，我們仍然致力於並堅信每月服用一次是正確的最佳給藥頻率，正如您所看到的口服家庭劑量一樣，我認為。隨著快速啟動，如果我們獲得標籤批准，我認為這顯然會成為我們巨大的競爭點。

Yes, and I think Brandon, just one more thing on there is the competitor only has induction on their weekly, so we will be the only monthly product with a with a rapid induction, which is a differentiator as it comes through. And listen, I'd be remiss without welcoming it to coverage of in. Thanks for picking us up.

是的，我認為布蘭登，還有一件事就是競爭對手只在每週進行誘導，所以我們將是唯一每月進行快速誘導的產品，這是一個差異化因素。聽著，如果我不歡迎它加入到報道中，那我就太失職了。感謝您接我們。

No, thanks very much. One more, if I may.

不，非常感謝。如果可以的話，我再說一次。

Just sort of, we talked about 2025 being a transition year and I appreciate all the color you gave. How do you think about a return to top line growth on a company basis in 2026? I understand you may not want to go there just yet, but just I thought I'd ask.

就像我們說的，2025 年是過渡年，我很感謝您給出的所有解釋。您如何看待 2026 年公司營收將恢復成長？我知道您可能還不想去那裡，但我還是想問一下。

Thank you.

謝謝。

Yes, listen, I think, given the transition year where after five to six years of enjoying, film exceeding every analog and having that pricing pressure and the fifth generic coming in, having SUBLOCADE, with new competition where the market is adjusting and we're dealing with the annualization of last year as well as new trial, when you start to look to 2026, you start to look to a market that's stabilized out. We're expecting share to stabilize out in long with the in line with the dual experienced dual LAI prescribers where it's 6,535. So, you'd expect that you're returning to growth in line with market growth, in 2016 and beyond. So, that's why we have such conviction. In the profitable growth framework is, once we get through the transition period, it's all about, a huge unmet need with over nine million people abusing, only three million diagnosed and at any point in time only 1.2 million in treatment with LAIs only at 8%. So, there's a tremendous opportunity where we have research that indicates about 30% of patients should be on LAI. So, there's a tremendous opportunity for growth and a tremendous opportunity for two competitors in the market, even though we see, our product as the clear leader.

是的，聽著，我認為，考慮到過渡年，經過五到六年的享受，膠片超越了每一種模擬，並面臨定價壓力，第五種仿製藥進入市場，有了SUBLOCADE，市場正在調整，新的競爭，我們正在處理去年的年度化以及新的試驗，當你開始展望2026年時，你就會開始期待一個已經穩定的市場。我們預計該股將在長期內保持穩定，與雙重經驗豐富的雙重 LAI 處方一致，為 6,535。因此，您可以預期，在 2016 年及以後，您的成長將與市場成長同步恢復。所以，這就是我們有如此信念的原因。在獲利性成長框架中，一旦我們度過過渡期，就會出現巨大的未滿足需求，超過 900 萬人濫用藥物，只有 300 萬人得到診斷，在任何時候都只有 120 萬人接受 LAI 治療，治療率僅為 8%。因此，我們有研究表明大約 30% 的患者應該使用 LAI，這是一個巨大的機會。因此，儘管我們認為我們的產品是明顯的領先者，但對於市場上的兩個競爭對手來說，仍有巨大的成長機會和巨大的機會。

Great thank you very much.

非常好，非常感謝。

Thank you Brandon.

謝謝你，布蘭登。

Thank you.

謝謝。

The next question is from Paul Cuddon from Deutsche Numis. Please go ahead.

下一個問題來自 Deutsche Numis 的 Paul Cuddon。請繼續。

Yes, good morning, guys. Just firstly a question on SUBLOCADE on the basis of your expectations for fourth quarter, 2024 were for a decline versus quarter three based on competitive pressures and sort of funding challenges in CGS that didn't ultimately materialize. So, I'm just wondering if you could comment on your initial guidance for SUBLOCADE on the basis that the funding pressures proved not to be quite as high as you thought in fourth quarter or even the exit rate for fourth quarter was a little bit stronger.

是的，大家早安。首先關於 SUBLOCADE 的一個問題，您對 2024 年第四季的預期是，由於競爭壓力和 CGS 的某種融資挑戰，與第三季相比會有所下降，但這些挑戰最終並未實現。所以，我只是想知道您是否可以對 SUBLOCADE 的初步指導做出評論，因為事實證明第四季度的資金壓力並不像您想像的那麼高，或者第四季度的退出率甚至更高一些。

Ryan, could you talk through the book, the fourth quarter, which was flattered as well as into the quarter one dynamics.

瑞安，您能否談談這本書、第四季的情況以及第一季的動態。

Yes, good morning, Paul.

是的，早安，保羅。

Certainly, it's a good question because the last time we spoke was in October and the fourth quarter results did play out stronger than expected, as we had mentioned, we had factored in some continued chair erosion. In the fourth quarter, that did not happen. If you look at our business on a clean, underlying basis, it grew 1% to 2% versus quarter three. So, that's our new starting point as we progress into 2025.

當然，這是一個好問題，因為我們上次談話是在十月份，第四季度的業績確實好於預期，正如我們所提到的，我們已經考慮到了一些持續的椅子侵蝕。但在第四季度，這種情況並沒有發生。如果從乾淨、基本的基礎來看我們的業務，與第三季相比，我們的業務成長了 1% 至 2%。所以，這是我們邁向 2025 年的新起點。

As we're looking at the quarterly ramp, I'm going to stay away from the details of exact phasing, but what I would say and break this down into two components for you. First, if you look at the base OHS business, that's expected to show consistent growth from year end to the high single low digit, double digits with the benefits of the increased HTP and patient media investments that Mark mentioned starting to ramp up more in the second half.

當我們觀察季度成長時，我將避開具體階段的細節，但我會將其分為兩個部分。首先，如果您看一下基礎的 OHS 業務，預計從年底到高個位數、低個位數、兩位數的持續增長將會出現，這得益於 Mark 提到的 HTP 和患者媒體投資的增加，而下半年這些投資將開始進一步增加。

And then if you look at the Justice Channel, as we just mentioned earlier, we started feeling that at the end of last year, the funding gaps and the impact is being felt, at the start of this year as well. And so, we have that still materializing in the first half, but we do see some step up in the second half as the year progresses.

如果你看看司法管道，正如我們剛才提到的，我們在去年年底就開始感覺到資金缺口和影響，今年年初也是如此。因此，我們在上半年仍然看到這一趨勢，但隨著時間的推移，我們確實看到下半年會出現一些進步。

But again, I do want to reemphasize the point I made earlier that this loss of volume of share is not tied to competition. It's primarily tied to the funding constraints at the facilities.

但我還是想再次強調我之前提到的觀點，即市佔率的損失與競爭無關。這主要與設施的資金限制有關。

And second for me on Suboxone dailies in the US, just wondering if you could elaborate on kind of where the pricing pressure is coming from. Is that sort of tablets or is that from the film competition? I mean, is there an opportunity for film to take shares from tablets and what visibility do you actually have on the fifth generic potential launch and how much is that kind of tied to your anticipated halving of sales?

其次，關於美國的 Suboxone 每日銷量，我只是想知道您是否可以詳細說明定價壓力來自哪裡。那是平板電腦嗎？我的意思是，電影是否有機會從平板電腦手中奪取市場份額，您對第五種通用藥物的潛在上市前景有何預期，這與您預期的銷售額減半有多少關係？

So, on the situation as we just mentioned, we've the category has been genericized for almost five to six years now, and we believe that we've manage that [liath] appropriately using the cash to fuel SUBLOCADE growth and also to return some capital to shareholders.

因此，正如我們剛才提到的情況，該類別已經通用化近五到六年了，我們相信我們已經管理好了這一點，適當地使用現金來推動 SUBLOCADE 增長並向股東返還一些資本。

What we've seen recently, just to provide you some more context, and I just want to remind you that since the fourth generic [engineists] entered in the market in quarter three '23, they immediately contributed to a price decay from their launch, and we've seen it throughout 2024 and there was for them to gain the volume and then they accelerated their pricing at the end of 2004 with the generic price dropping close to 15%. So, what we did, moving into 2025 was we formulated a sensible competitive response and adjusted our pricing in Medicaid to maintain the very important formulary position. And so that's what's in the base of our film guidance. On top of that, we always, most of the time factor in some underlying share erosion that we've seen over the last couple of years as well. And then in regard to the fifth generic, listen, as of now it has not come in, but we have factored, the appropriate level of response into our guide.

我們最近看到的情況只是為了給您提供更多背景信息，我只想提醒您，自從第四種仿製藥 [engineers] 在 2023 年第三季度進入市場以來，它們自推出後立即導致了價格下跌，我們在整個 2024 年都看到了這種情況，他們為了獲得銷量，然後在 2004 年底加速了定價，仿製藥價格下降了近 15%。因此，進入 2025 年，我們制定了合理的競爭應對措施，並調整了醫療補助的定價，以保持非常重要的處方集地位。這就是我們的電影指導的基礎。除此之外，我們大多數時候也會考慮過去幾年看到的一些潛在的份額侵蝕現象。然後關於第五種通用方法，聽著，到目前為止它還沒有出現，但我們已經將適當的回應等級考慮到了我們的指南中。

And Paul, just for the absence of doubt, we've factored in that pricing we took, but continued erosion throughout 2025, and we expect that trend to continue whether driven by the current competitive environment of the four players or fifth generic entering should have come along.

保羅，毫無疑問，我們已經考慮到了我們所採取的定價，但整個 2025 年都會持續侵蝕，我們預計這種趨勢將持續下去，無論是由四家公司的當前競爭環境推動，還是第五家通用公司進入。

Superb, thank you.

太棒了，謝謝。

Thanks for the questions, Paul.

謝謝你的提問，保羅。

Thank you.

謝謝。

The next question is from Chase Knickerbocker from Craig-Hallum. Please go ahead.

下一個問題來自 Craig-Hallum 的 Chase Knickerbocker。請繼續。

Good morning, guys, thanks for taking the questions. Just to start from me staying on SUBOXONE. I guess just to be clear within guidance, if we do see fifth generic launch, do you feel like you've largely accounted for that, fully accounted for it, or would you say that the majority of kind of the impact that you're pricing in is kind of some of these current dynamics just kind of putting the finer point there.

大家早安，感謝你們回答問題。我首先要繼續服用 SUBOXONE。我想只是為了在指導範圍內明確，如果我們確實看到第五種通用藥物的推出，您是否覺得您已經在很大程度上考慮到了這一點，完全考慮到了這一點，或者您是否會說您所定價的大部分影響是這些當前的動態，只是將更精細的要點放在那裡。

Yes, and perfectly fine with the clarification, Chase. What we've factored in is continued price erosion throughout the year whether driven from the current competitors or [1/5] entrance. So, you know we think we've encapsulated that within our current guidance.

是的，Chase，我完全同意你的澄清。我們已經考慮到，價格將全年持續下滑，無論是受到當前競爭對手的影響，還是 [1/5] 的進入。所以，您知道我們認為我們已經將其包含在我們當前的指導中。

So, if Teva was to launch, you believe that you've accounted for that impact in this in this guidance.

因此，如果 Teva 要推出該產品，您相信您已經在本指南中考慮到了這方面的影響。

Correct.

正確的。

And then just on the visibility to Teva, I mean, should we kind of take some of this conservatism as a level of visibility from you guys to that launch or just kind of any additional color there?

然後就 Teva 的可見性而言，我的意思是，我們是否應該將這種保守主義作為你們對此次發布的可見性水平，或者只是任何額外的顏色？

Yes, we don't have any visibility with regards to Teva. Obviously, they've been held out because of the court system and are free to launch at any point in what we know is a very profitable generic market. So, we would expect them to come in at some point. But we don't have any visibility with that.

是的，我們對 Teva 的情況一無所知。顯然，由於司法系統的緣故，他們被阻止進入該市場，並且可以在任何時候在我們所知道的利潤豐厚的仿製藥市場上推出產品。因此，我們期望他們會在某個時候加入。但我們對此並沒有任何了解。

But either way, what we saw through 2024 because of since the fourth entrant is we've seen pricing pressure continue and then accelerate in December where we saw a 15% decline in the generic pricing.

但無論如何，從 2024 年起，我們看到由於第四家進入者的存在，價格壓力持續存在，並在 12 月加速，通用藥物價格下降了 15%。

Got it, thanks. And then just on SUBLOCADE. Can you kind of walk us through your assumptions on a little bit of a final level as far as overall buprenorphine LAI market growth in 2025 that's inherent in the guidance in the US at least.

明白了，謝謝。然後就進入 SUBLOCADE 吧。您能否向我們簡要介紹一下您對 2025 年丁丙諾啡 LAI 市場整體成長的最終假設，這至少是美國指導範圍內的。

Yes, Ryan, could you please talk them through what the overall LAI market growth assumptions are related to how you talk through the other assumptions on guidance?

是的，Ryan，您能否向他們講解一下整體 LAI 市場成長假設與您談到的其他指導假設之間的關係？

Yes, so at this point though, we haven't really gotten into the exact market growth, but you can assume that last year we saw over, 35%-40% as the market continues to materialize. This year we predicted anywhere between 20% to 30% in the market. But keeping in mind in our guidance range we also factored in, continued share impact as we revert, closer to those analogs we've talked about.

是的，雖然目前我們還沒有真正了解確切的市場成長情況，但你可以假設去年隨著市場持續成長，我們的成長率超過 35%-40%。我們預測今年的市場成長率將在20%到30%之間。但請記住，在我們的指導範圍內，我們也考慮到了隨著我們恢復而持續的份額影響，更接近我們所談論的那些類似物。

So, my kind of rough back in the napkin math then is that you know kind of guidance for SUBLOCADE assumes that-- on a full year basis you're basically kind of at that 65% share level. Is that about fair?

因此，我粗略地計算了一下，您知道 SUBLOCADE 的指導假設——按全年計算，您基本上處於 65% 的份額水平。這樣公平嗎？

I would say that's a fair assumption, reasonable.

我想說這是一個公平的、合理的假設。

And then just lastly on kind of overall kind of CJS growth in, kind of within those growth assumptions, do you kind of expect CJS as a whole that portion of the market to be flat in 2025, or is there some growth there that your competitor is taking?

最後，關於 CJS 的整體成長，在這些成長假設範圍內，您是否預期 CJS 整體市場部分在 2025 年會持平，或者您的競爭對手是否會實現成長？

So, the way we're thinking about CGS. CGS will be down, year over year, and if you think about where the growth is in organized health systems and CGS is at about 20% in the system, it's going to be down about 30%- 35%. And it's going to be because of these funding constraints and some systems being forced to shift back to orals to ensure that every patient can receive treatment because of where we are. So, that starts right at the beginning of the year with regards to those impacts. Those are not competitive pressures in criminal justice and those are funding pressures.

這就是我們對 CGS 的看法。CGS 將逐年下降，如果您考慮有組織的醫療體系中的成長情況，並且 CGS 在系統中的比例約為 20%，那麼它將下降約 30%-35%。這是由於資金限制，一些系統被迫轉回口服藥物，以確保每個病人都能接受治療。所以，就這些影響而言，它從年初就開始了。這些不是刑事司法的競爭壓力，而是資金壓力。

We have built into our guidance a bit of competitive pressure in the market because we know this is an area that cameras or excuse me, that the competitors focusing on.

我們在指導中加入了一點市場競爭壓力，因為我們知道這是攝影機或對不起，競爭對手重點關注的領域。

Thanks guys.

謝謝大家。

Of course, thanks, Chase.

當然，謝謝你，蔡斯。

Thank you.

謝謝。

Well, I'll take the next question.

好吧，我來回答下一個問題。

This is from Christian Glennie from Stifel. Please go ahead.

這是來自 Stifel 的 Christian Glennie 提供的。請繼續。

Hi guys, thanks for taking the question. Maybe on the guide for SUBLOCADE and then and then specifically around in the core market OHS, you've talked there about, high single digit to double digit.

大家好，感謝你們回答這個問題。也許是在 SUBLOCADE 的指南中，然後特別是在核心市場 OHS 中，您已經談到了從高個位數到兩位數。

To what extent is that already reflecting the potential benefit you'll get from things like the label change and all the extra investment, the marketing commercial support you're giving for it, just trying to get a sense for how much that is already factored in the guidance or whether that could be a potential upside, it does sound like.

這在多大程度上已經反映了您從標籤更改和所有額外投資、為此提供的營銷商業支持等方面獲得的潛在利益，只是想了解這些因素在多大程度上已經考慮到了指導中，或者這是否可能是一個潛在的上升空間，聽起來確實是這樣的。

Some you could get some significant things like consumer and digital TV advertising about high pass through rate, low general awareness today. So, could there be some more meaningful growth, from the benefit of those activities, also trying to get a better sense for, what we should be getting from that $50 million dollar investment into SUBLOCADE, thanks.

你可以得到一些重要的東西，例如消費者和數位電視廣告，它們目前通過率高，但普遍認知度低。那麼，從這些活動的好處中是否可以獲得更有意義的增長，同時也試圖更好地了解，我們應該從對 SUBLOCADE 的 5000 萬美元投資中獲得什麼，謝謝。

So, thanks Christian. A couple of things there, so in the guide though certainly does factor in the market dynamics that we know today, some possible variation of some of these key drivers that we discussed this morning, and then also, some level of appropriate protection on the downside. And as we just mentioned, the high single digit low, double digit growth is a combination of the market growth of 20% to 30% and then, continued share impact as we progress through the year. And then we did factor in a return on our investment we're excited about these investments of HCP and patient awareness. Unfortunately, we start them in quarter one and in quarter two, and we have Those returns starting to roll out as we get into quarter three and quarter four at that point and that also includes the assumption that we will have that label update approved by that point.

所以，感謝克里斯蒂安。這裡有幾個因素，所以指南中確實考慮到了我們今天所知道的市場動態，我們今天早上討論的一些關鍵驅動因素的可能變化，以及對下行風險的一定程度的適當保護。正如我們剛才提到的，高個位數、低兩位數的成長是 20% 到 30% 的市場成長與全年持續的份額影響相結合的結果。然後我們確實考慮了投資回報，我們對這些 HCP 和患者意識的投資感到非常興奮。不幸的是，我們在第一季和第二季就開始了這些回報，而當我們進入第三季和第四季時，這些回報就開始陸續出現，這也包括我們將在那時批准該標籤更新的假設。

Thanks for that, Ryan. And maybe just a quick comment from Richard on why now to amp up the patient in [ACP] media.

謝謝你，瑞安。也許理查德只是想簡單評論為什麼現在要在 [ACP] 媒體上強調病人的重要性。

Yes, thanks, Mark. I think you know if you look at the macro dynamics or the potential, we spoke earlier about, the underuse of BMAT, the diagnosis rate. So, if you look at the opportunity, we have significant growth opportunity still exists in category penetration and also penetration of the LAI map. I think number one, and then if you look, while we while we dipped our toe back in 2019 and 2020, clearly it was pre-COVID. We had a lot less prescribers, so I think now we feel we've got a strong base for acceleration with regard to more above the line sort of like TV and digital.

是的，謝謝，馬克。我想如果你看一下宏觀動態或潛力，我們之前談到的 BMAT 的使用不足，診斷率。因此，如果你看一下機會，我們在類別滲透率以及 LAI 圖滲透率方面仍然存在顯著的成長機會。我認為第一點，如果你仔細觀察，你會發現，我們在 2019 年和 2020 年嘗試的時候，顯然是在新冠疫情之前。我們的處方人員少了很多，所以我認為現在我們感覺我們已經擁有了在電視和數位等更高層面加速發展的強大基礎。

Thank you, Richard.

謝謝你，理查。

Thanks. And then maybe on CGS just to clarify. You said the CGS will be down about 30% to 35% in '25. Is that's for the market in general, but also specifically SUBLOCADE. And then the second part on CGS is, you talked to a few things may be getting better, but is there any specific things that might help to stabilize or improve the funding? Dynamic within that part of the market because clearly that's sort of where people are sort of grappling a bit with is how do I get comfortable we'll see some stab at least some initial stabilization and maybe some improvement on that sort of funding part.

謝謝。然後也許只需對 CGS 進行澄清。您說過 CGS 在 25 年將下降約 30% 至 35%。這是針對一般市場而言的，但具體來說也針對 SUBLOCADE。然後關於 CGS 的第二部分是，您談到了一些事情可能會變得更好，但是是否有任何具體的事情可能有助於穩定或改善資金？市場這一部分的動態，因為很明顯這是人們正在努力解決的問題，我如何才能感到安心，我們會看到至少一些初步的穩定，也許在這種融資部分會有所改善。

Yes, so let me maybe take both of those, I think the first one with regards to CGS that 30% that is SUBLOCADE, and it's the funding pressures, a couple of major accounts shifting over to orals to ensure they can treat all patients, and a bit of expected competitive pressure in the market because we know that focus is there. What we are still seeing. We still have a funnel of new accounts that are looking to come on. They see LAIs as a solution. And even in the accounts that switched over to oral, the feedback was we love the LAIs. We think it's the right solution. We just need to treat these patients. And so as additional funding opportunities become available, there is an opportunity to switch it back and as we return to growth in criminal justice system. A moving ahead, so those funding vehicles, I think the first one that's right there front and center are the Medicaid 1,115 waivers.

是的，所以讓我把這兩者同時考慮一下，我認為第一個與 CGS 有關，其中 30% 是 SUBLOCADE，它是資金壓力，幾個主要帳戶轉向口服以確保他們能夠治療所有患者，以及市場上預​​期的一些競爭壓力，因為我們知道重點在那裡。我們至今仍在看到這樣的情況。我們仍有一批新帳戶正在等待加入。他們將 LAI 視為一種解決方案。甚至在那些已經轉為口語的帳號中，回饋也是我們喜歡 LAI。我們認為這是正確的解決方案。我們只需要治療這些病人。因此，隨著更多資金機會的出現，我們就有機會將其轉變回來，並恢復刑事司法系統的成長。繼續前進，在這些融資工具中，我認為最突出的是醫療補助 1,115 豁免。

We know there have been 16 states that have been approved for these. We know that there's going to be a GAAP from approval to when those become operationalized because prison systems work off of budgets. And they don't, and oddly they don't have fungibility between their health care budgets and their staffing and other budgets, which is why there's so much constraints, with regards to wanting to use LAIs, but they can't reallocate where they have the benefits, which is on the staffing levels, where they have the orals, so that puts the pressure on in the short term. And so with 1,115 waivers getting operationalized with the potentially influence in next budget year cycles, with regards to shifting from people over to health care, as well as with abatement funds continuing to increase and be and be operationalized, we think that funding in 2016 and beyond will start, the gaps will start to close or the funding will start to increase whichever way you care to look at it.

我們知道已有 16 個州批准了這些計劃。我們知道，從批准到實施都會有一個 GAAP，因為監獄系統是根據預算來運作的。但他們沒有，而且奇怪的是，他們的醫療保健預算和人員配備以及其他預算之間沒有可互換性，這就是為什麼在使用 LAI 方面存在如此多的限制，但他們無法重新分配他們有優勢的地方，也就是在人員配備水平上，他們有口服藥物的地方，所以這在短期內帶來了壓力。因此，隨著 1,115 項豁免得以實施，並可能對下一個預算年度週期產生影響，關於從人員轉向醫療保健，以及隨著減免資金繼續增加和實施，我們認為 2016 年及以後的資金將開始到位，缺口將開始縮小，或者資金將開始增加，無論你怎麼看。

Thanks. And then maybe last one on just to clarify, I think on your comments on capital allocation, did you say?

謝謝。然後也許最後一個問題只是為了澄清一下，我想你對資本配置的評論是怎麼說的？

Not currently considering shareholder returns and M&A [stroke] BD. I was just want to clarify that.

目前不考慮股東回報和併購[中風] BD。我只是想澄清這一點。

Yes, that's correct. What we're really focused on is fueling SUBLOCADE and the phase 2 assets through completion, meeting our financial obligations and ensuring financial flexibility through the transition period. And listen, clearly, capital allocation is a board decision in partnership with management, and they will continue to assess this actively moving forward.

是的，正確。我們真正關注的是推動 SUBLOCADE 和第二階段資產的完成，履行我們的財務義務並確保過渡期內的財務靈活性。聽著，顯然，資本配置是董事會與管理階層共同做出的決定，他們將繼續積極評估這項進展。

Okay, thanks.

好的，謝謝。

Thank you, Christian.

謝謝你，克里斯蒂安。

Thank you.

謝謝。

We have one more question. Last question today is from Brian Balchin from Jefferies. Please go ahead.

我們還有一個問題。今天的最後一個問題來自 Jefferies 的 Brian Balchin。請繼續。

Yes, thanks for squeezing me in. I'm just asking on behalf of James Tempest, his questions are if [OpEx] is $10 million to $15 million revenues and the changes in the cost structure, is this profitable or at what point will the product be profitable as it's understood that [OpEx] costs were higher than this when last laid out. And then secondly, if you go back three to four years, R&D was around $40 million or $50 million and you're guiding 85% to 90% despite, cutting some programs. So, I guess why isn't R&D lower? Thank you.

是的，謝謝你擠進來。我只是代表詹姆斯·坦普斯特 (James Tempest) 提問，他的問題是，如果 [OpEx] 的收入為 1000 萬美元到 1500 萬美元，並且成本結構發生變化，這是否有利可圖，或者產品在什麼時候才會盈利，因為據了解，上次規劃時 [OpEx] 成本高於這個數字。其次，如果回顧三到四年前，研發費用約為 4,000 萬美元或 5,000 萬美元，儘管削減了一些項目，但您仍預計其研發費用將達到 85% 到 90%。那麼，我想問為什麼研發費用沒有降低呢？謝謝。

Ryan, you want to cover both the [OpEx] the sort of costs as well as the R&D profile.

瑞安，你想涵蓋[OpEx] 成本以及研發概況。

Yes, so with the [OpEx] cost they are directly aligned with the programs that Richard mentioned in terms of the awareness, getting more traction on the standing orders in some of these trial programs, so they're directly tied to the strategy of the business.

是的，因此，[OpEx] 成本與 Richard 提到的計劃直接相關，在知名度方面，在一些試驗計劃中獲得了更多的常規訂單牽引力，因此它們與業務戰略直接相關。

They've been relatively flat year over year, and you know we believe as we get into next year the business will be a creative at that point.

與去年同期相比，我們的業績相對平穩，我們相信，進入明年，業務將會更具創意。

[And OUD could I just] Maybe just highlight this is a very small team due to the very narrow call point in public interest. So, this is not like the SUBLOCADE sales force. It's a very small focused team because of the very unique call point that's there.

[而 OUD 我能不能] 可能只是強調一下，由於公眾利益的呼聲點非常狹窄，所以這是一個非常小的團隊。所以，這不像 SUBLOCADE 銷售團隊。這是一個非常小的專注團隊，因為那裡的呼叫點非常獨特。

Sorry. And then on your question about R&D, so what the current guide represents, it's primarily now the progression of our phase 2 OUD assets, some residual studies on SUBLOCADE. And just a continuation of generating real world evidence that is a key asset for us as we share it with our teams to help educate the market on our product.

對不起。然後關於您關於研發的問題，目前指南所代表的主要是我們的第二階段 OUD 資產的進展，以及對 SUBLOCADE 的一些剩餘研究。我們將繼續產生現實世界的證據，這對我們來說是一項重要資產，因為我們與我們的團隊分享這些證據，以幫助市場了解我們的產品。

Thank you very much.

非常感謝。

Thank you for the questions, Brian.

感謝您的提問，布萊恩。

Thank you. And there are no further questions, I'll now hand back to Mark Crossley, CEO for any closing comments.

謝謝。沒有其他問題了，現在我將把麥克風交還給執行長馬克‧克羅斯利 (Mark Crossley)，請他發表結束語。

Thank you, Sarah, and that officially closes out our fiscal year 2024 results call. We appreciate the continued interest and support and Indivior, and we look forward to seeing everyone in the near future.

謝謝你，莎拉，這正式結束了我們 2024 財年業績電話會議。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與大家見面。

Thank you.

謝謝。

Thank you. This concludes today's conference call.

謝謝。今天的電話會議到此結束。

Thank you for participating, and you may now disconnect.

感謝您的參與，您現在可以斷開連接。