Indivior PLC (INDV) 2024 Q3 法說會逐字稿

Morning and afternoon, everyone. Before we begin, I need to remind everyone that on today's call, we may make forward-looking statements that are subject to risks and uncertainties and that actual results may differ materially. We list those factors on page 4 of this morning's announcement that is available on our website at www.indivior.com.

早上和下午，大家。在開始之前，我需要提醒大家，在今天的電話會議上，我們可能會做出前瞻性陳述，這些陳述存在風險和不確定性，實際結果可能會有重大差異。我們在今天上午公告的第 4 頁列出了這些因素，該公告可在我們的網站 www.indivior.com 上查看。

Finally, given where we are in the quarter end close process, we ask that you limit your questions to the matters discussed in today's announcement. We will address third quarter results and broader Q&A at our formal results.

最後，考慮到我們在季度末結算流程中的進展，我們要求您將問題限制在今天公告中討論的事項上。我們將在正式業績中討論第三季業績和更廣泛的問答。

With that, I will turn the call over to Mark Crossley, our CEO.

接下來，我會將電話轉給我們的執行長馬克‧克羅斯利 (Mark Crossley)。

Thanks, Jason, and good morning and good afternoon, everyone. Thanks for joining us on short notice. Ryan Preblick, our CFO, is also joining us here today. I'm sure by now that you've read the announcement where we've described the challenging market dynamics that we've been navigating, which have adversely impacted our near-term financial performance and outlook. Let me walk you through the highlights.

謝謝傑森，大家早安，下午好。感謝您在短時間內加入我們。我們的財務長 Ryan Preblick 今天也加入了我們的行列。我相信現在您已經閱讀了我們的公告，其中我們描述了我們一直在應對的充滿挑戰的市場動態，這對我們的近期財務業績和前景產生了不利影響。讓我帶您了解亮點。

For our revised near-term outlook, we've seen several external factors combined to create lower net revenue visibility and greater than expected initial adoption of the competitor products. First, we have seen increased competitive pace and intensity. Our competition is gaining initial adoption among SUBLOCADE incumbant prescribers faster than our expectations.

對於我們修訂後的近期前景，我們發現幾個外部因素結合在一起導致淨收入可見度較低，且競爭對手產品的初始採用率高於預期。首先，我們看到競爭節奏和強度的增加。我們的競爭產品在 SUBLOCADE 現任處方者中的初步採用速度比我們預期的要快。

In addition, in the criminal justice system channel, we're experiencing both increased competitive pressure, including modest pricing pressure as well as more unpredictable volumes due to funding variability in some accounts. Recall, this channel is largely dependent upon government funding, including grants and legislative allocations to fund patient treatment.

此外，在刑事司法系統管道中，我們面臨日益增加的競爭壓力，包括適度的定價壓力，以及由於某些帳戶的資金波動而導致的交易量更加難以預測。回想一下，這個管道在很大程度上依賴政府資金，包括資助病患治療的補助和立法撥款。

In some activated accounts, incremental SUBLOCADE volume is pending this funding, while in others strong continued SUBLOCADE uptake has exceeded designated budgets resulting in temporary treatment lapse. As a result, while our CGS business grew strongly year over year, we're expecting to see a sequential net revenue decline in this channel in the third quarter because of these two issues.

在一些啟動的帳戶中，增量 SUBLOCADE 數量正在等待這筆資金，而在其他帳戶中，持續強勁的 SUBLOCADE 吸收量已超過指定預算，導致暫時治療失效。因此，雖然我們的 CGS 業務同比強勁成長，但由於這兩個問題，我們預計第三季該通路的淨收入將連續下降。

That said, among our CDS accounts, we continue to see great interest and intention to treat the SUBLOCADE. And therefore, we continue to expect strong contribution to SUBLOCADE growth from this channel in the long term.

也就是說，在我們的 CDS 帳戶中，我們仍然看到人們對處理 SUBLOCADE 表現出極大的興趣和意願。因此，從長遠來看，我們繼續預計該管道將對 SUBLOCADE 的成長做出強勁貢獻。

Lastly, we're seeing increased one-off impact from additional destocking in the quarter, and that's in addition to the dynamics we spoke with the Q2 update.

最後，我們看到本季額外去庫存帶來的一次性影響增加，這是我們在第二季更新中談到的動態之外的。

These factors have combined to make SUBLOCADE net revenue forecasting accuracy difficult in the near term. In light of recent developments, we've incorporated our learnings and updated our fiscal year 2024 guidance. We believe this new net revenue guidance for SUBLOCADE is achievable, and we still expect to show solid year-over-year growth for SUBLOCADE in fiscal year '24 of 17% at the midpoint. However, as you'd expect, we're actively seeking efficiencies to accelerate this growth and support margins.

這些因素結合在一起，導致 SUBLOCADE 近期淨收入預測的準確性變得困難。鑑於最近的事態發展，我們整合了我們的經驗教訓並更新了 2024 財年指導。我們相信 SUBLOCADE 的新淨收入指引是可以實現的，而且我們仍然預計 24 財年 SUBLOCADE 的年比穩健成長為 17%（中位數）。然而，正如您所期望的那樣，我們正在積極尋求效率來加速成長並支持利潤率。

Looking further out, we now expect a period of slower growth for SUBLOCADE in the near term as the market adjusts to two players in the long acting injectable category. This expected slower growth period means we no longer expect to deliver a $1 billion annual net revenue run rate for SUBLOCADE exiting 2025.

展望未來，隨著市場適應長效注射劑類別的兩個參與者，我們現在預計 SUBLOCADE 的成長將在短期內放緩。這一預期的成長放緩意味著我們不再期望 2025 年退出的 SUBLOCADE 能夠實現 10 億美元的年淨收入運行率。

Simply, the competitor's growth from initial HCP adoption will largely come at the expense of SUBLOCADE. We continue to believe that SUBLOCADE has a greater than $1.5 billion peak net revenue potential. And despite competitive inroads and temporarily lowered growth profile, we're seeing strong evidence that SUBLOCADE is sustaining its leadership position in the category.

簡而言之，競爭對手從最初採用 HCP 中獲得的成長將主要以犧牲 SUBLOCADE 為代價。我們仍然相信 SUBLOCADE 的最高淨收入潛力超過 15 億美元。儘管競爭激烈且成長前景暫時下降，但我們看到強有力的證據表明 SUBLOCADE 正在維持其在該類別中的領導地位。

We've been tracking multiple market cohorts since the competitor's launch a year ago. And while we have seen faster than expected initial adoption, recent market data is consistently showing that SUBLOCADE share is stabilizing over the past four months at levels demonstrating its leading position in the clinic. If maintained at these levels, it confirms our belief that SUBLOCADE's unique product profile will lead to its continued leadership role in the long-acting injectable category.

自從一年前競爭對手推出以來，我們一直在追蹤多個市場群體。雖然我們看到的初始採用速度快於預期，但最近的市場數據一致表明，SUBLOCADE 的份額在過去四個月中穩定在表明其在臨床中領先地位的水平。如果保持在這些水平，它證實了我們的信念，SUBLOCADE 獨特的產品概況將使其在長效注射劑類別中繼續發揮領導作用。

When we look further out at the potential for long acting injectables overall, we believe there remains huge scope for increased market penetration and growth. HCP Research continues to suggest approximately 30% of patients in their practices will be treated with a long-acting injectable. Recent data shows the share of LAIs as a portion of medically-assisted treatment, buprenorphine medically-assisted treatment, is approximately 7% with SUBLOCADE garnering most of the share.

當我們進一步審視長效注射劑的整體潛力時，我們相信市場滲透率和成長仍有巨大的空間。HCP Research 繼續建議，約 30% 的患者將接受長效注射劑治療。最近的數據顯示，LAI 作為醫療輔助治療（丁丙諾啡醫療輔助治療）的一部分，佔 7%，其中 SUBLOCADE 佔了大部分份額。

We obviously hope for better recent performance and are taking several measures to ensure we maintain SUBLOCADE's leading position among long acting injectable prescribers. First, our Chief Commercial Officer, Richard Simkin, has taken on direct leadership of day-to-day operations of SUBLOCADE in the United States.

我們顯然希望近期能有更好的表現，並正在採取多項措施來確保我們保持 SUBLOCADE 在長效注射處方者中的領先地位。首先，我們的首席商務官 Richard Simkin 直接領導了 SUBLOCADE 在美國的日常運作。

Second, we expect to improve SUBLOCADE's patient experience through important label updates. As you will have seen on Monday, we were again granted Priority Review by the FDA for these updates, which include alternate injection sites for SUBLOCADE induction and maintenance, as well as the ability to rapidly induce a patient on SUBLOCADE after a single dose of transmucosal buprenorphine . In fact, if approved, SUBLOCADE will be the only monthly injectable approved for rapid induction for OUD patients.

其次，我們希望透過重要的標籤更新來改善 SUBLOCADE 的病患體驗。正如您週一所看到的，我們再次獲得 FDA 對這些更新的優先審查，其中包括 SUBLOCADE 誘導和維持的替代注射部位，以及在單劑量經粘膜注射後快速誘導患者使用 SUBLOCADE 的能力丁丙諾啡。事實上，如果獲得批准，SUBLOCADE 將成為唯一被批准用於 OUD 患者快速誘導的每月注射劑。

We expect these are elements to be incorporated into SUBLOCADE's US label in February and based upon research and anecdotal feedback, we expect this to be strongly received by both treatment providers and patients. As a reminder, we recently updated the label to allow for storage of SUBLOCADE at room temperature for up to 12 weeks, and this product is already in the market.

我們預計這些元素將在二月納入 SUBLOCADE 的美國標籤中，根據研究和軼事回饋，我們預計這將受到治療提供者和患者的強烈歡迎。提醒一下，我們最近更新了標籤，允許 SUBLOCADE 在室溫下保存長達 12 週，並且該產品已經上市。

Third, as I previously indicated, we are actively seeking efficiencies to fuel cell SUBLOCADE's growth and support margins. More specifically, we'll look to increase investment behind SUBLOCADE awareness as well as general awareness of long acting injectables as our research shows that treatment awareness among OUD patients remains low, less than 15% of patients are aware of any brand name in the category.

第三，正如我之前指出的，我們正在積極尋求提高燃料電池SUBLOCADE 成長效率並支持利潤率。更具體地說，我們將尋求增加對SUBLOCADE 認知度以及長效注射劑普遍認知度的投資，因為我們的研究表明OUD 患者的治療認知度仍然很低，不到15% 的患者知道該類別中的任何品牌名稱。

These initiatives will complement the sales force and justice team expansion we completed earlier this year where we continue to see increased productivity. Our increased call frequency and productivity has yielded approximately 120 new Justice entities this year through the second quarter, and we're seeing expansion in the number of patients they treat each month. Additionally, growth in new prescribing HCP also is continuing with an absolute increase in treatment providers year over year.

這些舉措將補充我們今年稍早完成的銷售團隊和司法團隊的擴張，我們將繼續看到生產力的提高。今年到第二季度，我們增加的呼叫頻率和工作效率催生了約 120 個新的司法機構，而且我們看到他們每月治療的患者數量也在增加。此外，新開處方的 HCP 也持續成長，治療提供者的絕對數量逐年增加。

In closing, while we face greater near term competitive and market headwinds than we had predicted, we remain firm in our conviction that SUBLOCADE has the ideal profile to meet the needs of patients. SUBLOCADE attains therapeutic levels of dosing in 4 to 8 hours and maintains dosing levels the entire month after one shot. We do not believe that any other long-acting injectable achieves that during the dosing period and this is playing out in the cohorts of early competitor adopters where we're seeing SUBLOCADE leading share stabilize over the last three to four months.

最後，雖然我們近期面臨的競爭和市場阻力比我們預期的要大，但我們仍然堅信 SUBLOCADE 具有滿足患者需求的理想配置。SULOCADE 在 4 至 8 小時內達到治療劑量水平，並在註射一次後整個月維持劑量水平。我們認為，在給藥期間，任何其他長效注射劑都無法實現這一目標，而這一點正在早期競爭對手採用者群體中發揮作用，我們看到SULOCADE 的領先份額在過去三到四個月內保持穩定。

And of course, the disease space continues to have a tremendous unmet need with 8 of 10 patients not in treatment. Taken together, this gives us confidence in the long term net revenue opportunity we see for SUBLOCADE of greater than $1.5 billion. In sum, we're still near the beginning of the journey than the end, and we remain excited about the potential for SUBLOCADE.

當然，疾病領域仍有巨大的未滿足需求，十分之八的患者沒有接受治療。總而言之，這讓我們對 SUBLOCADE 超過 15 億美元的長期淨收入機會充滿信心。總而言之，我們仍然接近旅程的開始而不是結束，我們仍然對 SUBLOCADE 的潛力感到興奮。

With that overview, I'll turn it over to questions and answers.

有了這個概述，我將把它轉為問題和答案。

(Operator Instructions) James Vane-Tempest, Jefferies.

（操作員說明）James Vane-Tempest，Jefferies。

Hi. Thanks for taking my questions. A couple, please. Firstly, given we have a profit warning in the summer and then we've had another one, what confidence can you give us, I guess, there's not going to be a third profit warning? And also on the $1.5 billion peak revenue number and if we should be thinking that's going to be achievable at a later date now?

你好。感謝您回答我的問題。請來一對。首先，鑑於我們在夏季發布了盈利預警，然後又發布了一次盈利預警，您能給我們什麼信心，我想，不會有第三次盈利預警？還有 15 億美元的峰值收入數字，我們是否應該考慮現在可以在以後實現這一目標？

And then my second question is, you talk about slower growth for SUBLOCADE in the near term, but how should we think about the level of investment here? So with more competition, should we be thinking accelerating SG&A next year or you need to do to defend your market position.

我的第二個問題是，您談到近期 SUBLOCADE 的成長放緩，但我們應該如何考慮這裡的投資水準？因此，隨著競爭的加劇，我們是否應該考慮明年加快 SG&A，還是您需要採取行動來捍衛您的市場地位。

Thanks for that good questions, James. I think as we think about the volatility that we've seen in this market, what we've seen is really a confluence of events, intensified competition, short-term funding fluctuations and certain CGF accounts and stocking levels below previously reduced amounts.

謝謝你提出的好問題，詹姆斯。我認為，當我們思考我們在這個市場中看到的波動時，我們看到的實際上是一系列事件的綜合，競爭加劇，短期資金波動以及某些CGF 帳戶和庫存水平低於之前減少的金額。

I think as we've taken the learnings that we've gotten from those three elements and incorporated those into this guidance, it gives us confidence that we set a guidance that we can achieve in the balance to go. So we have good conviction in that number.

我認為，當我們從這三個要素中學習並將其納入本指南時，它讓我們有信心製定一個可以在未來平衡中實現的指南。所以我們對這個數字很有信心。

On the greater than $1.5 billion peak net revenue guidance, we've never guided the timing on that but these initial cohorts, the end market data that we're seeing with regards to breakthrough and the lack of hold of the competitive product and the fact that physicians believe efficacy is the number one thing driving their decision, give us increased conviction behind that greater than $1.5 billion.

對於超過 15 億美元的峰值淨收入指導，我們從未指導過具體時間安排，但這些初始群體、我們看到的有關突破和缺乏競爭產品的最終市場數據以及事實醫生認為療效是推動他們做出決定的首要因素，這讓我們更確信這超過15 億美元的資金背後。

When we think about next year's profile, I think we'll guide on fiscal year 2025 when we get to the February fiscal year end. I think as we think about our capital allocation, we'll be actively managing that capital allocation with a focus on both fueling growth and preserving margin.

當我們考慮明年的概況時，我認為我們將在 2 月財年結束時以 2025 財年為指導。我認為，當我們考慮我們的資本配置時，我們將積極管理資本配置，並專注於促進成長和維持利潤率。

Thank you. We'll now move to our next question. Chase Knickerbocker, Craig Hallum.

謝謝。現在我們將討論下一個問題。蔡斯·尼克博克、克雷格·哈勒姆。

Morning, guys. Thanks for taking the questions. So if we kind of look at what guidance range assumes for Q4, it kind of assumes a 9% sequential decline. Should we think of any kind of headwinds as kind of onetime in Q4? Should we be kind of thinking about this being kind of the new normal as far as what the competitive environment is at this point? And then can you kind of talk us through the split of what kind of drives that SUBLOCADE kind of decline sequentially more so? Is it CJS competition and CJS or is it on the direct prescriber side? And then kind of can you walk us through some of your assumptions as far as kind of what that assumes from kind of new patient share that your competitor is taking? Thank you.

早安，夥計們。感謝您提出問題。因此，如果我們看看第四季的指導範圍，就會發現季減 9%。我們是否應該將任何類型的逆風視為第四季度的一次性事件？就目前的競爭環境而言，我們是否應該考慮這是一種新常態？然後您能否告訴我們，SUBLOCADE 類型依序下降的驅動器類型是怎樣的？是 CJS 競爭和 CJS 還是直接處方者一方？然後，您能否向我們介紹您的一些假設，以及您的競爭對手正在採取的新病患份額的假設？謝謝。

Maybe I'll start with the last one and then head into the items with regards to the Q4 dynamics, Chase. I think, listen, we're still seeing in line with the dynamics we saw at the half year where the predominant amount of new patient share is still coming to SUBLOCADE, which is encouraging. And combine that with the cohort data and it just further supports SUBLOCADE's role here and eventual share leadership as the market stabilizes out.

也許我會從最後一項開始，然後進入有關第四季度動態的項目，Chase。我認為，聽著，我們仍然看到與半年看到的動態一致，其中大部分新病患份額仍然來自 SUBLOCADE，這是令人鼓舞的。並將其與隊列數據相結合，它進一步支持了 SUBLOCADE 在這裡的作用，並隨著市場穩定下來，最終支持份額領先地位。

As we look to the Q4 guide, really with the three drivers that we had, I would say the predominant two drivers were the accelerated competition with their accelerated initial adoption. And the dynamics in CJS. with a bit of increased competition and the funding dynamics which are exacerbated as we approach fiscal year end for both the federal and state entities. I would say, we probably have built in about $10 million or so of continued stocking dynamics and then the balance of that is equally split between the other two dynamics.

當我們查看第四季度指南時，實際上是我們擁有的三個驅動程序，我想說最主要的兩個驅動程序是加速競爭及其加速的初始採用。以及 CJS 的動態。隨著聯邦和州實體接近財政年度結束，競爭加劇，融資動態加劇。我想說，我們可能已經投入了大約 1000 萬美元左右的持續庫存動力，然後將其餘額平均分配給其他兩項動力。

Got it. And then just on -- specifically on the criminal justice side, is it safe to assume that in Q4 that kind of shortfall there is mainly the competitive conversions rather than the funding headwinds? And then kind of how do you think about your profile there relative to your competitor as they obviously look to take additional share there?

知道了。然後，特別是在刑事司法方面，是否可以安全地假設第四季度的這種短缺主要是競爭性轉換而不是資金阻力？那麼，相對於你的競爭對手，你如何看待你在那裡的形象，因為他們顯然希望在那裡獲得額外的份額？

And then just last for me, when we think about what kind of helps you stabilize kind of the share in the market here, do you think kind of all that's required is that kind of February PDUFA with those last two remaining product profile items or what are you hearing from your customers as far as what's driving increased sampling? Thank you.

最後對我來說，當我們考慮什麼可以幫助您穩定這裡的市場份額時，您認為所需要的只是那種 2 月 PDUFA 以及最後兩個剩餘的產品配置文件或什麼您是否從客戶那裡了解到推動抽樣增加的原因？謝謝。

So a lot to unpack there. Let me maybe get into there. When we think about the CJS dynamic, listen, I think it's a combination of both. We had competition and we shared this at earlier conferences because it was in the acuity data where they got access to a large account on the West Coast that we had not factored in and we're seeing this funding issues that are exacerbated, the federal sort of fiscal year end is at the end of September and then many of the states are at the end of the year.

那裡有很多東西需要解壓。也許讓我進去一下。當我們思考 CJS 的動態時，聽著，我認為這是兩者的結合。我們有競爭，我們在之前的會議上分享了這一點，因為在敏銳度數據中，他們可以訪問我們沒有考慮到的西海岸的一個大帳戶，我們看到這種資金問題正在加劇，聯邦類型財政年度結束時間是九月底，然後許多州都到了年底。

And the -- this ramp-up in adoption bumps up against their budgets. We see this as a transient sort of issue as they increase their budgets, get more grants and the flow of funds down into this very critical treatment area. So we'll see some lumpiness as this goes as adopters come in, and they've got an in-year budget during their period of adoption. But we'll work our way through that as they get additional funding.

而且——採用率的增加超出了他們的預算。我們認為這是一個暫時的問題，因為他們增加了預算，獲得了更多撥款，資金流向了這個非常關鍵的治療領域。因此，隨著採用者的加入，我們會看到一些混亂，並且他們在採用期間有年內預算。但當他們獲得額外資金時，我們將努力解決這個問題。

And as we look towards the profile in criminal justice, I think it's similar to outside the walls. When you're looking at it, then what would be the more normal sort of treatment arena? These criminal justice systems are looking for something that they can reduce their overall use of resources and will keep these patients with therapeutic doses the entire month-long. So we see SUBLOCADE playing a greater role in the justice system versus competition.

當我們審視刑事司法領域的概況時，我認為它與牆外相似。當你看到它時，那麼更正常的治療領域是什麼？這些刑事司法系統正在尋找可以減少資源整體使用的方法，並使這些患者在整個月內接受治療劑量。因此，與競爭相比，我們看到 SUBLOCADE 在司法系統中發揮更大的作用。

As we look to stabilization, listen, I think there is just going to be a transition period here that's going to lead to continue a bit of slower growth as the competitor product continues to get initial adoption and that transition period will lead to slower growth. I think that there will be some elements as we continue to focus on awareness disease based and take away some of the features that are differentiated versus the competition like the alternate sites of injection, like rapid induction and create some additional benefits and differentiation for us. Like, we will be the only monthly with rapid induction, which is a significant benefit in CJS because you'll have less resource utilization than doing weekly doses.

當我們尋求穩定時，聽著，我認為這裡將會有一個過渡期，隨著競爭對手的產品繼續獲得初步採用，這將導致成長繼續放緩，而過渡期將導致成長放緩。我認為，隨著我們繼續專注於基於疾病的認識，並取消一些與競爭對手不同的功能，例如替代注射部位，例如快速誘導，並為我們創造一些額外的好處和差異化，將會有一些因素。例如，我們將是唯一進行快速誘導的每月一次，這對 CJS 來說是一個顯著的好處，因為與每週一次相比，您的資源利用率會更低。

So we see those as help, but we think there will be a transition period while the competition continues to get adoption. But remember, those cohorts, Chase, I think the key here is that when we look at those cohorts, they stabilize out over about a year period and we see over three to four months that they stabilize with us in share leadership.

因此，我們認為這些是有幫助的，但我們認為，在競爭繼續被採用的同時，將會有一個過渡期。但請記住，這些群體，蔡斯，我認為這裡的關鍵是，當我們觀察這些群體時，他們在大約一年的時間內穩定下來，我們看到他們在三到四個月的時間裡與我們一起穩定在份額領導地位。

Paul Cuddon, Deutsche Numis.

保羅卡登，德國努米斯。

I've got two questions, please. First, you've not mentioned the Medicaid disenrollments in this particular updates. I'm just wondering if you could give us a bit of an update on the status of that?

我有兩個問題，請教。首先，您在此特定更新中沒有提到醫療補助退出。我只是想知道您能否給我們一些有關該狀態的最新資訊？

And then secondly, just on the kind of potential growth products to be expanding the market into patients that are not currently treated. Would you kind of conclude that the competitor weekly product has not been successful in expanding the market that if you are able to offer the rapid induction of multi-site injection that would be a game changer for the broader patient populations that are not currently (technical difficulty)

其次，就是將市場擴展到目前未接受治療的患者的潛在成長產品。您是否會得出這樣的結論：競爭對手的每週產品在擴大市場方面並未成功，如果您能夠提供多部位注射的快速誘導，這將改變目前尚未實現的更廣泛患者群體的遊戲規則（技術難度）

You were breaking up there a little bit, Paul, but I think I got both of your questions. We haven't mentioned the Medicaid disenrollments because they continue as we built into our guidance, our last guidance update. So the dynamics haven't changed. We still are through the vast majority of those one more state and expect it to disenroll by November and then three more states left for next year. So the dynamics are as expected and reflects the (technical difficulty) heading into 2025.

保羅，你在那裡有點分手了，但我想我明白了你的兩個問題。我們沒有提到醫療補助的退出，因為它們在我們納入我們的指南（我們的最新指南更新）時仍在繼續。所以動力沒有改變。我們仍然完成了其中的絕大多數州的申請，預計到 11 月會退出，然後還有另外三個州留到明年。因此，動態符合預期，並反映了進入 2025 年的（技術難度）。

When it comes to expanding the market (technical difficulty) the result of -- the competition has commercially focused on initiating trials in LAI adopters and key accounts that have taken LAIs into their patient pieces. So we're the only people out there that are focused on actually growing the market and the market -- it has enabled us to grow 17% year over year but we haven't grown our assets we want because of the cannibalization (multiple speakers)

當談到擴大市場（技術難度）時，競爭的商業重點是在 LAI 採用者和將 LAI 納入其患者產品的關鍵客戶中啟動試驗。因此，我們是唯一真正專注於發展市場和市場的人——它使我們能夠同比增長 17%，但由於蠶食，我們還沒有增長我們想要的資產（多個發言者）

When we think about moving forward, we expect as the market stabilizes that share of voice from having two LAI products as well as two salesforce out there will start to accelerate growth in the market once the market stabilizes out.

當我們考慮前進時，我們預計，隨著市場穩定，擁有兩種 LAI 產品和兩名銷售人員的聲音份額將開始加速市場成長。

Last question on pricing, is this something we should be assuming is under a bit of pressure on the price per dose in the future or that --?

關於定價的最後一個問題，我們是否應該假設未來每劑價格面臨一些壓力，或者——？

Yeah. Listen, overall, as I mentioned, pricing is constructive and there's open access across the category that allows patients and HCPs to make the decision for the product that's best for them. Sometimes they believe that's an oral and then long acting.

是的。聽著，總的來說，正如我所提到的，定價是有建設性的，並且整個類別都有開放的訪問權限，允許患者和 HCP 做出最適合他們的產品的決定。有時他們認為這是口頭的，然後是長期的表演。

We have seen the competition use price as a tool in select justice system account and believe that's how they won the account we spoke about on the West Coast where price sensitivity, given some of the funding sources, are dependent on grants and legislative actions.

我們已經看到競爭對手在選擇司法系統帳戶中使用價格作為工具，並相信這就是他們贏得我們在西海岸談到的帳戶的方式，考慮到某些資金來源，價格敏感性取決於撥款和立法行動。

To be clear, we're prepared to take appropriate steps to defend our business that we believe are in the best interest of the therapy area. So we think of equal price and then enabling choice. And for us, we believe when there's free choice, SUBLOCADE will continue to hold the number one position as we've talked with regards to the dynamics on the cohorts, efficacy as the number one value item. So I hope that provides the context you're looking for.

需要明確的是，我們準備採取適當的措施來捍衛我們的業務，我們認為這符合治療領域的最佳利益。所以我們考慮同等價格，然後提供選擇。對我們來說，我們相信，當有自由選擇時，SUBLOCADE 將繼續保持第一的位置，正如我們所討論的，隊列的動態、功效是第一價值項目。所以我希望這能提供您正在尋找的背景。

Okay. And just one final one, just on the buyback and that's continuing, you've not put it in the statement.

好的。最後一個，只是關於回購，而且還在繼續，你沒有把它寫在聲明中。

No, that's continuing. That launched in August and as we mentioned, while we plan on having that -- have a duration of six months.

不，這還在繼續。該計畫於八月啟動，正如我們所提到的，雖然我們計劃這樣做，但持續時間為六個月。

David Amsellem, Piper Sandler.

大衛·阿姆塞勒姆，派珀·桑德勒。

I have three questions. Number one, can you talk to the extent to which the smaller needle size associated with Brixadi is hurting your business?

我有三個問題。第一，您能談談與 Brixadi 相關的較小針頭尺寸對您業務的損害程度嗎？

Secondly, can you talk to where you think your share of new starts is going to settle out as you get through this transition period from being the only game in town to now being part of a two-player market?

其次，你能談談當你經歷從唯一的遊戲到現在成為兩人市場的一部分的過渡時期時，你認為你的新開始份額將在哪裡解決嗎？

And then lastly, given all the different moving parts that are conspired to result in a couple of times of lowered guidance, how are you thinking about 2025? And can you give us at least a roadmap as to what conservative achievable expectations for '25 would look like? Or maybe I'll ask it a different way, what have you learned from the '24 experience?

最後，考慮到所有不同的變化因素共同導致指引數次下調，您對 2025 年有何看法？您能否至少給我們一個路線圖，說明保守的 25 年可實現的期望是什麼樣的？或者也許我會換個方式問，你從 24 小時的經驗中學到了什麼？

With regards to the smaller needle, I think this is certainly a feature and I think it's used and sounds good in the experience with the patient. When you look to the Phase 3 studies for both of our products, there's similar adverse event percentages. I think we were 8.7%, they were just over 9.9% with regards to pain of injection. And we hypothesized that's because of the buprenorphine coming in contact with the subcu.

關於較小的針頭，我認為這肯定是一個功能，並且我認為它在患者的體驗中被使用並且聽起來不錯了。當您查看我們兩種產品的第三階段研究時，您會發現不良事件的百分比相似。關於注射疼痛，我認為我們是 8.7%，他們剛剛超過 9.9%。我們推測這是因為丁丙諾啡與 subcu 接觸所致。

So we don't see pain as a major differentiation. I think there's some some features there that should win out with efficacy. We believe that the alternate injection sites will take some of that issue with the larger needle away because you won't be injecting in the abdomen and there won't be as much of a visual reinforcement of that. So we think that new label change that should come in February will certainly be helpful with regards to that experience and that feature benefit that the competition has with smaller needle.

所以我們不認為疼痛是一個主要的區別。我認為其中的一些功能應該以功效取勝。我們相信，替代注射部位將解決較大針頭的一些問題，因為您不會在腹部注射，並且不會有太多的視覺強化。因此，我們認為二月應該推出的新標籤變更肯定會對這種體驗和競爭對手使用較小的針頭帶來的功能優勢有所幫助。

With regards to new starts with two players, I think the key here is where will this end up? I think we have to look to the cohort data with where the market is ending up with these early adopters, the people that you would have said are into the new technology, they're adopting the new technology or they have a strong belief in the concept that surrounds the competition that led to that early adoption.

關於兩位球員的新開始，我認為這裡的關鍵是最終會是什麼樣子？我認為我們必須專注於隊列數據，了解這些早期採用者的市場最終走向，這些人可能會說他們喜歡新技術，他們正在採用新技術，或者他們對新技術有堅定的信念圍繞競爭的概念導致了早期採用。

And what we see with those cohorts is that we have strong share leadership as they settle out, and we've seen good stabilization over three to four months that reinforce that belief on strong leadership for SUBOCADE.

我們在這些群體中看到的是，當他們安定下來時，我們擁有強大的股票領導力，並且我們在三到四個月內看到了良好的穩定，這強化了對 SUBOCADE 強大領導力的信念。

David, I respect the question with regards to the moving pieces that we'll -- and where do we get to with -- where guidance will be for 2025, but I think that's for us to give with the fiscal year end results. I think we've talked about a continued transition period as the market adjusts to two players and the accelerated adoption of the competitors that comes through the fact that they're focusing on heavy SUBLOCADE users or key accounts and not focused on growing the market. So we expect that cannibalization to continue.

大衛，我尊重關於我們將採取哪些行動的問題，以及我們將如何處理 2025 年的指導，但我認為這是我們在財年最終結果中給出的。我認為我們已經討論過隨著市場適應兩個參與者的持續過渡期以及競爭對手的加速採用，這是因為他們專注於大量 SUBLOCADE 用戶或關鍵客戶，而不是專注於發展市場。因此，我們預計這種蠶食會持續下去。

But oddly, the fact that it's accelerated actually is -- in some odd ways, it's a positive because the market should stabilize out sooner and we can get to a growing market helping patients and we believe with that, that SUBLOCADE will be the leader in the space.

但奇怪的是，事實上，它的加速實際上是——在某些奇怪的方面，這是積極的，因為市場應該更快穩定下來，我們可以進入一個不斷增長的市場來幫助患者，我們相信，SUBLOCADE 將成為該領域的領導者。

Thibault Boutherin, Morgan Stanley.

蒂博·布瑟林，摩根士丹利。

Thank you. First question from me is on the market share, you mentioned in the early call. And when you're monitoring things here, are you seeing initially a swing in favor of Brixadi and then the share coming back to SUBLOCADE as maybe a decision in life science in the breakthrough issue once they've done kind of experimenting Brixadi, they come back to SUBLOCADE? So just if you still think the sort of market share swing?

謝謝。我的第一個問題是關於市場份額，您在早期電話會議中提到過。當你在這裡監控事情時，你是否看到最初有利於Brixadi 的搖擺，然後份額回到SUBLOCADE，這可能是生命科學領域在突破性問題上的決定，一旦他們完成了Brixadi 的實驗，他們就會來返回子位置？那麼，您是否仍認為市佔率會出現波動呢？

And second question is just you mentioned that three, four months to get to the stable market share in these early cohorts, how does that translate into the broader patient population because if it's three, four months, you should be relatively quick to get to kind of stable market share in the market. So clearly, your guidance assumes Q4, you're going to see headwinds.

第二個問題是，您剛才提到，要在這些早期群體中獲得穩定的市場份額，需要三、四個月的時間，這如何轉化為更廣泛的患者群體，因為如果是三、四個月，您應該相對較快地達到目標市場佔有率穩定。很明顯，您的指導假設是第四季度，您將看到逆風。

So when do you think that [process] is in Q4, Q1 next year to be challenging to go through this? Basically, when do you expect to see SUBLOCADE turning to growth? `Maybe starting with that and I have a follow-up on the on the CJS.

那麼，您認為明年第四季、第一季的[流程]何時完成會具有挑戰性？基本上，您預計何時看到 SUBLOCADE 轉向成長？「也許從這個開始，我在 CJS 上有一個後續行動。

I think dose cohorts -- I appreciate the question there, Thibault. And I think with the shape of those, yeah, you do see them go up and they come -- and they do even come back down. But throughout the entire shape of the curve is we look at the SUBLOCADE is maintaining strong share leadership, which is good for us that we do see the shape come back down near the end.

我認為劑量隊列——我很欣賞蒂博提出的問題。我認為，從它們的形狀來看，是的，你確實看到它們上升、下降，甚至會下降。但在整個曲線形狀中，我們看到子位置保持著強勁的份額領先地位，這對我們來說是件好事，因為我們確實看到形狀在接近尾聲時回落。

And just to be -- clarify my position with regards to the stabilization, those early cohorts that would have started a year ago, 11 months ago, 10 months ago, they're stabilizing now over the last three to four months. So it takes time once people try and they adopt. And remember, these are the early innovators that are adopting that we're analyzing, it takes time for those to stabilize out.

只是為了澄清我對穩定的立場，那些在一年前、11 個月前、10 個月前開始的早期群體，在過去的三到四個月裡現在正在穩定下來。因此，一旦人們嘗試並採用，就需要時間。請記住，這些是我們正在分析的早期創新者，它們需要時間才能穩定下來。

So as we look at timing, that's going to be the one moving forward with regards to how long that transition period will be with the next wave of adopters, how long it takes for them to get that penetration, get the adoption in the market to stabilize out. But we expect that to happen. And in the medium to long term, we fulsomely believe that SUBLOCADE's growth thesis is completely intact and stand behind the greater than $1.5 billion peak net revenue.

因此，當我們考慮時機時，這將是關於下一波採用者的過渡期需要多長時間、他們需要多長時間才能獲得滲透、獲得市場採用的時間。但我們預計這會發生。從中長期來看，我們完全相信 SUBLOCADE 的成長論點是完整的，也是超過 15 億美元高峰淨收入的背後。

Thank you for the clarifications. And just the last one on the criminal justice system, could you just help us understand what is the presence here in terms of kind of winning or losing accounts, how dynamic these accounts are? Is it the [understand] committed volumes, if you could just help us understand how it works?

感謝您的澄清。關於刑事司法系統的最後一個問題，您能否幫助我們了解這裡有哪些獲勝或失敗的帳戶，這些帳戶的動態如何？如果您能幫助我們了解它是如何運作的，它是[理解]承諾的捲嗎？

Yeah, I wish there was a standard system for this that I could share to you but it really is jail system to system, depending on how they're dealing with it. Some are binary only, one product, some have both and have utilization across and it just varies product to product with regards to that.

是的，我希望有一個標準系統可以分享給你，但這確實是監獄系統到系統的不同，這取決於他們如何處理它。有些只是二進制的，一種產品，有些則兩者兼而有之，並且可以跨產品使用，只是在這方面因產品而異。

I think for us the key is what's needed to be successful in a justice system. One, they're worried about resource use utilization and reliability and having less doses, is important to them. And then two, they want those patients to be stabilized all month long because if there's breakthrough earlier, they're going to have to come back for additional treatment or oral doses or things of that nature.

我認為對我們來說關鍵是司法系統成功需要什麼。第一，他們擔心資源利用率和可靠性，並且減少劑量對他們來說很重要。第二，他們希望這些患者整個月都保持穩定，因為如果更早取得突破，他們將不得不回來接受額外的治療或口服劑量或類似性質的東西。

So we see those as the primary drivers and there's, as we talked, there's always a bit of a cost sensitivity there. But we -- again, we believe in let's get our costs in line and then let the systems choose which product they want to use.

因此，我們將這些視為主要驅動因素，正如我們所說，那裡總是存在著一定的成本敏感性。但我們再次相信，讓我們的成本保持一致，然後讓系統選擇他們想要使用的產品。

Christian Glennie, Stifel.

克里斯蒂安·格倫尼，史蒂菲爾。

Hi, guys. Thanks for taking the questions. And apologies if I missed this earlier. Just on your market share of new patients, I think you said you had the dominant share. But could you be more specific around that? I think previously you were on the sort of 70%, 80% new patient starts. What that level would be today?

嗨，大家好。感謝您提出問題。如果我之前錯過了這一點，我深表歉意。就您的新患者市場份額而言，我想您說過您擁有主導份額。但您能更具體地說一下嗎？我認為以前有 70%、80% 的新患者開始治療。今天這個水平會是多少？

And then just maybe I can push you again, maybe a bit more on the '25 guide in terms of directional here. Are we potentially in a decline in '25 of flat or better growth? My thinking here is we'll probably have some Q1 and Q2, maybe some continuing decline trends and better recovery in the second part of the year gets you to flat. Just anything, a bit more direction here on '25, please?

然後也許我可以再次推動你，也許更多關於 '25 指南的方向。我們是否有可能在 25 世紀出現下滑或成長持平或更好的情況？我的想法是，我們可能會出現第一季和第二季的情況，也許今年下半年一些持續的下降趨勢和更好的復甦會讓你持平。只是任何事情，請在 25 年這裡提供更多指導，好嗎？

Thanks, Christian, for the question. I think, listen, we haven't closed out the quarter and have the data with a lag with regards to the new patient share. So I think we're going to hold off on the specificity of -- with regards to that. But we haven't seen material changes at least in some of the initial data throughout the quarter versus what we talked at the half year. Again, with regards to the 2025 guide, I think I've been about as specific as I can be with regards to the forces in the transition period as we look to next year. And what we'll do is we'll guide on that in February with regards to where we see SUBLOCADE and the overall company net revenue projections next year.

謝謝克里斯蒂安提出的問題。我想，聽著，我們還沒有結束這個季度，而且數據與新患者份額相比存在滯後。所以我認為我們將暫緩討論這一點的特殊性。但與我們在半年中討論的數據相比，我們至少在整個季度的一些初始數據中沒有看到重大變化。再說一次，關於 2025 年指南，我認為我已經盡可能具體地闡述了我們對明年過渡期的影響力。我們要做的是，我們將在 2 月就 SUBLOCADE 的位置以及明年公司整體淨收入預測提供指導。

Okay, thank you. And then a follow-up, if I can? Just a reflection, maybe a splitting out the sort of moving parts versus where you are today versus where you started the year, just to get that sort of relative weightings in terms of the impacts of the various things through the year, if you can? Starting the year at that midpoint 35% guide and now this 17% today for the midpoint. Yeah, the various dynamics that you've talked about through the year, just -- either a portion into the different factors here, please.

好的，謝謝。然後是後續行動，如果可以的話？只是一個反思，也許可以將活動部分與你今天的情況和你今年開始的情況分開，只是為了獲得一年中各種事情的影響的相對權重，如果可以的話？今年開始的中點為 35%，現在為中點 17%。是的，您一年來談到的各種動態，請介紹這裡不同因素的一部分。

Yeah, I think, listen, it has been a confluence of many events that have hit this year and provided significant volatility. And I think if you think through the factors of the transitory items like the Medicaid renewal, the Change Healthcare, and the stocking dynamics which we expect to stabilize out and as we enter next year, get to more of the CJS -- the competitive environment and sort of CJS funding and making certain we incorporate those into our forecasting.

是的，我想，聽著，這是今年發生的許多事件的匯合，並帶來了巨大的波動。我認為，如果你考慮臨時專案的因素，例如醫療補助更新、醫療保健變革以及我們預計穩定下來的庫存動態，當我們進入明年時，就會更多地了解 CJS——競爭環境以及CJS 資金，並確保我們將這些納入我們的預測中。

And taking the learnings we have to make certain we're able to accurately guide the market moving forward. And in addition, take those learnings that we have and speak to the additional conviction it provides with regards to the growth thesis on SUBLOCADE in the medium and the long term because, again, that stabilizing of those cohorts, what we're hearing in the market with regards to breakthrough and lack of hold. I mean for physicians today with high-powered synthetic opioids, if a patient relapses from treatment, they're a potential overdose victim. And so I think that's just coming to the forefront and we see that in the HCP research, but this efficacy is their number one -- force on their choice of what they're going to use.

吸取教訓，確保我們能夠準確地引導市場向前發展。此外，利用我們所學到的知識，並談談它為 SUBLOCADE 的中長期增長論文提供的額外信念，因為，這些群體的穩定，我們在市場的突破和缺乏把握。我的意思是，對於當今使用高效合成鴉片類藥物的醫生來說，如果患者治療後復發，他們就是潛在的藥物過量受害者。所以我認為這只是最前沿的，我們在 HCP 研究中看到了這一點，但這種功效是他們的首要任務——迫使他們選擇要使用的東西。

(Operator Instructions) Paul Cuddon, Deutsche Numis.

（操作員說明）Paul Cuddon，Deutsche Numis。

Thank you guys for taking my follow-up. I'm just wondering on how you're thinking of the cost base heading into FY25 as well? I mean, the SG&A line and the R&D line are quite something and you've hinted at efficiencies, but to what extent should we think about the ability to realize those?

謝謝你們接受我的跟進。我只是想知道您如何看待 2025 財年的成本基礎？我的意思是，SG&A 線和研發線相當重要，你已經暗示了效率，但我們應該在多大程度上考慮實現這些目標的能力？

I don't want to get into a tremendous amount of detail there, but I think we can rest assured that we're actively assessing our capital allocation with a focus on both growth of SUBLOCADE as well as supporting margins.

我不想透露太多細節，但我認為我們可以放心，我們正在積極評估我們的資本配置，重點是 SUBLOCADE 的成長以及支援利潤率。

I think we've shown a willingness to make tough choices in the past. Think about recent even -- recent decisions on PERSERIS on stopping [A-List] development which all provides flexibility on costs as we enter 2025. And we still believe we have a number of other levers, which we continue to assess, including items such as discretionary spending, capital and other cash items. And then we'll look to fuel SUBLOCADE and support margins through that process.

我認為我們過去已經展現了做出艱難選擇的意願。想想最近 PERSERIS 停止 [A-List] 開發的決定，這些決定在我們進入 2025 年時都提供了成本彈性。我們仍然相信我們還有許多其他槓桿，我們將繼續評估這些槓桿，包括可自由支配支出、資本和其他現金項目等項目。然後我們將尋求透過該流程推動子定位並支持利潤。

Christian Glennie, Stifel.

克里斯蒂安·格倫尼，史蒂菲爾。

Follow-up, please. Just to understand the things that you have in your toolkit as it relates to sort of pushing back and competing back against the competitive headwinds here. Obviously, you've talked about the profile, SUBLOCADE is better monthly as a pure sort of education thing. And maybe we'll see -- as we see the breakthroughs with a competitor that will play out more in favor of SUBLOCADE, but specifically anything else around salesforce sizes may be or marketing or anything else that sort of -- or price even. I mean, so is there anything else that you're sort of thinking about as your sort of strategy beyond the sort of education around the profile of SUBLOCADE?

請跟進。只是為了了解您的工具包中包含的內容，因為它與這裡的競爭逆風的反擊和競爭有關。顯然，您已經談到了個人資料，SUBLOCADE 每月作為一種純粹的教育活動更好。也許我們會看到——正如我們看到競爭對手的突破將更加有利於SUBLOCADE一樣，但特別是圍繞銷售人員規模的其他任何事情可能是營銷或其他任何類似的事情——甚至是價格。我的意思是，除了圍繞 SUBLOCADE 的概況進行教育之外，您還考慮過其他什麼作為您的策略嗎？

I think this is an important item, Christian, and I think part of this having a year with the competitor in the market certainly informs us and those cohorts where they're stabilizing out with strong share leadership for SUBLOCADE certainly inform our belief that we have the right product, the right profile efficacy in reinforcing the message on efficacy as the number one factor with physicians. A patient who relapses as a potential overdose victim and making making certain that that dynamic is heard out there and then further reinforcing the profile of SUBLOCADE.

我認為這是一個重要的項目，克里斯蒂安，我認為與市場上的競爭對手一起度過這一年的一部分肯定會告訴我們和那些通過SUBLOCADE 的強大份額領導力穩定下來的群體肯定會告訴我們這樣的信念：我們已經正確的產品、正確的形像功效可以向醫師強調功效是第一因素。一名患者作為潛在的服藥過量受害者而復發，並確保這種動態能夠被聽到，然後進一步強化 SUBLOCADE 的形象。

Taking that and then supplementing it with broader patient awareness of both SUBLOCADE and LAIs to drive patients into treatment, we see as a key. And then just continued strong execution by both our sales force as well as our criminal justice team. These are the folks on the ground that are going to continue to drive SUBLOCADE's growth as we get through this transitionary period of this initial adoption because it stabilizes out as a tremendous, tremendous opportunity for SUBLOCADE.

我們認為，以此為基礎，輔以更廣泛的患者對 SUBLOCADE 和 LAI 的認識，以推動患者接受治療。然後我們的銷售團隊和刑事司法團隊繼續強而有力的執行。當我們度過最初採用的過渡期時，這些人將繼續推動 SUBLOCADE 的成長，因為它穩定下來，為 SUBLOCADE 帶來了巨大的機會。

With regards to pricing, I'll just reinforce my comment earlier. Listen, we want to take price out of the equation for our stakeholders. We believe that this disease space for 20 years has been focused on open access and reducing barriers to treatment and choices across the entire decision set. And we think that's what's right in the best interest of patients and physicians if they have that choice for the best medication based on where they are in their journey.

關於定價，我剛才會強調我的評論。聽著，我們希望將價格從利害關係人的考慮中剔除。我們相信，這個疾病領域 20 年來一直專注於開放取用並減少整個決策過程中的治療和選擇障礙。我們認為，如果病人和醫生可以根據自己所處的階段選擇最佳藥物，那麼這才是最符合病人和醫生利益的做法。

Thank you. We're showing no more questions currently, so I'll turn the call back to you, Mark, for any closing comments.

謝謝。目前我們沒有再提出任何問題，因此我會將電話轉回給您，馬克，以徵求任何結束意見。

Thank you, Sarah, and thanks, everyone, for joining on short notice for this update. We'll speak to you again with our full Q3 results at the end of the month. Thank you.

謝謝莎拉，也謝謝大家在短時間內加入本次更新。我們將在本月底再次與您聯繫，並提供第三季的完整結果。謝謝。