Indivior PLC (INDV) 2024 Q2 法說會逐字稿

Good morning, everyone. Before we begin, I need to remind everyone that on today's call, we may make forward-looking statements that are subject to risks and uncertainties and that actual results may differ materially. We list the factors that may cause our results to be materially different on slide 2 of this presentation. We also may refer to non-GAAP measures, the reconciliations for which may also be found in the appendix to the presentation that is now posted on our website at indivior.com.

大家早安。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，實際結果可能會存在重大差異。我們在本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。我們也可以參考非公認會計準則 (non-GAAP) 指標，其對帳表也可在現已發佈於我們網站 indivior.com 上的簡報附錄中找到。

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

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

Thank you, Jason, and good morning and good afternoon, everyone. Thanks for joining us. Joining me today are Dr. Christian Heidbreder, our Chief Scientific Officer; Jeff Burris, our Chief Legal Officer; and Ryan Preblick, our Chief Financial Officer. I'll quickly highlight our results and some updates from our release earlier in the month, and then Ryan will detail the financials and our full-year 2024 outlook. We'll then open the line for questions.

謝謝你，傑森，大家早安，下午好。感謝您的加入。今天與我一起出席的還有我們的首席科學官 Christian Heidbreder 博士、我們的首席法律官 Jeff Burris 和我們的財務長 Ryan Preblick。我將快速介紹我們的業績以及本月早些時候發布的一些更新，然後 Ryan 將詳細介紹財務狀況和我們 2024 年全年的展望。然後我們將開放問答熱線。

Our results for the second quarter were in line with the expectations we preannounced earlier this month. SUBLOCADE delivered year-over-year net revenue growth in the quarter of 24%. As we previously discussed, SUBLOCADE's growth continued to be impacted by transitory headwinds, which we expect to ease during the second half and especially as we look into 2025.

我們第二季的業績符合我們本月稍早宣布的預期。SUBLOCADE 本季淨收入年增 24%。正如我們之前所討論的，SUBLOCADE 的成長持續受到暫時性逆風的影響，我們預計這種影響將在下半年，尤其是在展望 2025 年時得到緩解。

There are two significant new items in today's announcement. The first is that we've taken a $75 million provision for the agreed quantum of an expected settlement for opioid litigation brought by certain municipalities and tribal nations. This continues our path of proactively resolving legacy litigation items at the right value for shareholder certainty.

今天的公告中有兩項重要的新內容。首先，我們已為某些市政當局和部落國家提起的鴉片類藥物訴訟的預期和解金額約定了 7,500 萬美元。這延續了我們積極主動地以適當的價值解決遺留訴訟事項以確保股東確定性的道路。

The second item is the Board's decision to initiate a new $100 million share repurchase program, which we will seek to execute in an accelerated timeframe given the attractive value the shares currently represent. This new buyback program is a strong indication of our confidence in delivering on our intermediate and long-term objectives for SUBLOCADE exiting 2025 at $1 billion net revenue run rate and achieving greater than $1.5 billion in peak annual net revenue.

第二項是董事會決定啟動一項新的 1 億美元股票回購計劃，鑑於目前股票所代表的吸引力，我們將尋求在加速的時間內執行該計劃。這項新的回購計畫有力地表明了我們對實現 SUBLOCADE 的中期和長期目標的信心，即在 2025 年結束時實現 10 億美元的淨收入運行率，並在峰值年淨收入時實現超過 15 億美元的收入。

I'm not going to repeat everything we outlined in our July 9 release, but I do want to provide a few incremental updates since that announcement. First, we're starting to see the benefits of our increased commercial investments behind SUBLOCADE. Recall that over the past year, we've increased our field force by 50% in our justice systems team by 25%. And we're seeing significant increases in customer engagement and activation as a result.

我不會重複我們在 7 月 9 日發布的版本中概述的所有內容，但我確實想提供自該公告以來的一些增量更新。首先，我們開始看到增加對 SUBLOCADE 的商業投資所帶來的好處。回想一下，在過去的一年裡，我們的司法系統團隊的實地人員增加了 50%，而我們的司法系統團隊的人員增加了 25%。因此，我們看到客戶參與度和活躍度顯著提高。

In terms of key metrics, through the end of Q2, we've increased active SUBLOCADE dispensing HCPs to over 7,200 from approximately 6,700 at the end of fiscal year 2023. And we've active -- activated approximately 120 new CGS facilities thus far in 2024 to reach over 700 total activated justice system accounts.

就關鍵指標而言，截至第二季末，我們已將活躍的 SUBLOCADE 配藥 HCP 數量從 2023 財年末的約 6,700 個增加到 7,200 多個。到 2024 年為止，我們已經啟動了大約 120 個新的 CGS 設施，總共啟動的司法系統帳戶超過 700 個。

Second, we've completed the actions related to the cessation of PERSERIS sales and marketing. We thank our former colleagues for their professionalism and past contributions to Indivior, and we wish them the very best for the future. Additionally, we anticipate making product available to patients for up to a year to help manage treatment transition. Third, we expect fulfillment of the BARDA contract for OPVEE to begin this quarter, which, as a reminder, will amount to approximately $8 million in net revenue in fiscal year 2024.

第二，我們已經完成了停止PERSERIS銷售和行銷的相關行動。我們感謝前同事的專業精神和過去對 Indivior 的貢獻，並祝福他們未來一切順利。此外，我們預計將向患者提供長達一年的產品，以幫助管理治療過渡。第三，我們預計 OPVEE 與 BARDA 的合約將於本季開始履行，值得一提的是，這將使 2024 財年的淨收入達到約 800 萬美元。

Lastly, in terms of key items for the quarter, we're pleased to complete our US primary listing at the end of June with strong support from shareholders. Over time, we expect the benefits to be increased awareness of Indivior among the US investment community and US index inclusion. As part of this effort, we'll begin reporting in US GAAP next year, starting with our first Form 10-K filing in March 2025. This is a key requirement for US index inclusion.

最後，就本季的關鍵事項而言，我們很高興在股東的大力支持下於 6 月底完成美國主要上市。隨著時間的推移，我們預計其好處是提高美國投資界對 Indivior 的認識並將其納入美國指數。作為此項努力的一部分，我們將於明年開始按照美國公認會計準則 (US GAAP) 進行報告，並從 2025 年 3 月提交第一份 10-K 表格開始。這是納入美國指數的關鍵要求。

Next, I want to call out some highlights from our regularly report -- regular quarterly reported card. Beginning with SUBLOCADE patients and treatment that which grew to 49% year over year to 160,400 at the end of the second quarter. On a sequential basis, this represents a 7% increase with over 10,000 patients gain in the quarter. Recall, we target greater than 270,000 patients to deliver our peak net revenue goal of greater than $1.5 billion.

接下來，我想從我們的定期報告—定期季度報告卡中重點介紹一些內容。從 SUBLOCADE 患者和治療開始，到第二季末，患者和治療數量年增 49%，達到 160,400 人。與上一季相比，這一數字增長了 7%，本季增加了 10,000 多名患者。回想一下，我們的目標是超過 27 萬名患者，以實現超過 15 億美元的最高淨收入目標。

SUBLOCADE dispenses of 155,700 increased 25% versus last year and 5% versus the prior quarter. The difference between the sequential dispense growth rate of 5% and the net revenue growth of 7% is primarily due to destocking activity in Q1.

SUBLOCADE 的發藥量為 155,700 份，較去年同期成長 25%，較上一季成長 5%。連續分配成長率 5% 與淨收入成長率 7% 之間的差異主要是由於第一季的去庫存活動。

I'm also pleased to report that our alternate sites of care efforts are continuing to show good progress. The number of SUBLOCADE injections at these sites increased 55% in the second quarter compared to the previous quarter, and our network has now grown to over 1,200 locations across 22 states with 5 partners.

我還很高興地報告，我們的替代護理地點工作正在繼續取得良好進展。與上一季相比，這些站點的 SUBLOCADE 注射數量在第二季度增加了 55%，我們的網路現已發展到 22 個州的 1,200 多個地點，擁有 5 個合作夥伴。

Looking at diversification, we continue to build a funding trial and experienced environment for OPVEE, which we're confident will translate into paying customers over time. In the short term, we are facing some pushback to adoption from the views of certain harm reduction advocates. We'll continue to engage these voices with science and real-world evidence to counteract them and accelerate adoption as we believe the ultimate goal must be to save lives. Meanwhile, as I just highlighted, we expect delivery on the BARDA contract to begin this quarter, which will account for most about these net revenue in fiscal year 2024.

從多樣化來看，我們將繼續為 OPVEE 建立融資試驗和經驗豐富的環境，我們相信隨著時間的推移，這將轉化為付費客戶。短期內，我們面臨某些減害倡導者對採用該標準的阻力。我們將繼續用科學和現實世界的證據來反駁這些聲音，並加速採用，因為我們相信最終目標必須是拯救生命。同時，正如我剛才強調的那樣，我們預計 BARDA 合約將於本季度開始交付，這將佔 2024 財年淨收入的大部分。

Turning to our rest of world business, we continue to see good growth in contribution from our new products, SUBLOCADE and SUBOXONE film. Their solid progression is helping us offset the ongoing challenges to our legacy tablet products. In particular, ex-US sales of SUBLOCADE grew 25% year over year in the first half to $25 million, with growth led by Canada and an increasing contribution from the Nordics.

談到我們在世界各地的業務，我們繼續看到新產品 SUBLOCADE 和 SUBOXONE 薄膜的貢獻良好成長。他們的穩定進步正在幫助我們抵消傳統平板電腦產品所面臨的持續挑戰。尤其是上半年 SUBLOCADE 在美國以外的銷售額年增 25%，達到 2,500 萬美元，其中加拿大是成長最快的市場，北歐的貢獻也不斷增加。

You should note that our order timing and elevated stocking in the year-ago quarter had an adverse impact on overall rest of world performance. That said, we continue to expect modest growth for the full year.

您應該注意到，我們去年同期的訂單時間和庫存增加對世界其他地區的整體表現產生了不利影響。儘管如此，我們仍然預計全年經濟將保持溫和成長。

Turning to our pipeline, a few highlights to mention starting with SUBLOCADE, where we've completed the clinical studies supporting important label updates for rapid induction and alternate sites of injection, and we'll be making regulatory submissions to the FDA this quarter. We announced that Indivior 2000 has commenced Phase 2 development with patient dosing starting last month. Our excitement about this asset reflects our belief in the significant unmet need for non-opioid option for patients as part of the OUD treatment continuum.

談到我們的產品線，首先要提到的幾個亮點是 SUBLOCADE，我們已經完成了支持快速誘導和替代注射部位的重要標籤更新的臨床研究，我們將在本季度向 FDA 提交監管申請。我們宣布 Indivior 2000 已開始第二階段開發，並在上個月開始為患者提供劑量。我們對這項資產的興奮反映了我們的信念，即作為 OUD 治療連續體的一部分，患者對非鴉片類藥物治療的需求存在巨大的未滿足需求。

Turning to AEF0117 for cannabis use disorder, we expect top-line results from the clinical Phase 2b study this quarter, which we'll release when final. In terms of next steps we would then expect to have an end-of-Phase 2 meeting with the FDA to discuss the Phase 2b data as well as clinical Phase 3 study design and clinical endpoints. We'll then evaluate the outcome from that meeting, the clinical results and our market research to form a view on commercial potential. This will inform our decision on whether to exercise our option on the asset and enter Phase 3 development.

談到大麻使用障礙的 AEF0117，我們預計本季臨床 2b 期研究的頂線結果將會公佈，最終結果將會公佈。就下一步而言，我們預計將與 FDA 舉行第 2 階段結束會議，討論第 2b 階段數據以及第 3 階段臨床研究設計和臨床終點。然後，我們將評估會議的結果、臨床結果和市場研究，以形成對商業潛力的看法。這將為我們是否行使資產選擇權並進入第三階段開發的決定提供參考。

Finally, on clinical developments, I'll just quickly highlight that we discontinued INDV-5004 during event for acute cannabinoid overdose based on our assessment of a limited market opportunity for the product.

最後，關於臨床發展，我只想快速強調一下，根據我們對該產品有限的市場機會的評估，我們在急性大麻素過量事件期間停止了 INDV-5004 的使用。

Moving to capital allocation, as I noted, we're today announcing a new $100 million buyback based on our confidence in delivering against our medium-term profitable growth framework. We're also making good progress in resolving legacy litigation matters. As we disclosed at the start of this month, we've agreed to pay $85 million to certain end payers ending the antitrust trial that was scheduled to begin on July 15.

談到資本配置，正如我所指出的，我們今天宣布一項新的 1 億美元回購計劃，基於我們對實現中期獲利成長框架的信心。我們在解決遺留訴訟問題方面也取得了良好進展。正如我們在本月初披露的那樣，我們已同意向某些最終付款人支付 8500 萬美元，以結束原定於 7 月 15 日開始的反壟斷審判。

In addition, we are today taking a $75 million provision for an agreed settlement amounts for certain opioid litigation, including the opioid MDL matters related to municipalities and tribal nations. While this quantum is agreed and payable over multiple years, the parties still must negotiate material terms and conditions of the final settlement agreement. We expect to make a further disclosure upon reaching that final settlement.

此外，我們今天還拿出 7,500 萬美元，作為某些鴉片類藥物訴訟的和解金額，包括與市政當局和部落國家有關的鴉片類藥物 MDL 事宜。雖然這筆金額已達成協議並需在多年內支付，但雙方仍必須就最終和解協議的具體條款和條件進行協商。我們希望在達成最終解決方案後做出進一步披露。

With that, I'll hand over to Ryan.

說完這些，我就把麥克風交給瑞安 (Ryan)。

Thanks, Mark, and good morning and good afternoon to everyone. This was a challenging quarter as a result of the transitory headwinds affecting SUBLOCADE and the changed market outlook for PERSERIS. I nevertheless want to reiterate Mark's confidence that we are on track to deliver against our medium-term profitable framework and create significant shareholder value.

謝謝，馬克，大家早安，下午好。由於 SUBLOCADE 受到暫時不利因素影響以及 PERSERIS 市場前景發生變化，本季充滿挑戰。儘管如此，我還是想重申馬克的信心，我們正朝著實現中期獲利框架的目標前進，並創造巨大的股東價值。

For today, I will start my comments by summarizing the financial impacts of our decision to end the sales and marketing of PERSERIS before briefly walking you through the financials for the second quarter and closing on our full-year guidance, which we revised on July 9. Our strategic decision to end the promotional PERSERIS will result in a charge of approximately $65 million with $42 million recognized this quarter and the balance of approximately $23 million in Q3.

今天，我將首先總結我們決定終止 PERSERIS 銷售和行銷所帶來的財務影響，然後簡要介紹第二季度的財務狀況，並總結我們在 7 月 9 日修訂的全年指引。我們終止促銷 PERSERIS 的策略決策將導致約 6,500 萬美元的費用，其中本季確認 4,200 萬美元，第三季確認的餘額約為 2,300 萬美元。

This charge includes severance costs, write-offs for inventory, equipment and intangibles, and other termination payments. The cash impact will be approximately $20 million and will largely be incurred in Q3. On an annualized basis, we expect this result in savings of approximately $50 million with $20 million included in a revised SG&A guidance for full year 2024.

該費用包括遣散費、庫存、設備和無形資產的註銷以及其他解僱補償金。現金影響約 2000 萬美元，主要發生在第三季。以年率計算，我們預計這將節省約 5,000 萬美元，其中 2,000 萬美元包含在 2024 年全年修訂後的銷售、一般及行政費用 (SG&A) 指南中。

Turning to the performance drivers in the quarter, starting with the top line, total net revenue of $299 million reflected growth of 8% versus the year-ago quarter, both on a reported basis and at constant exchange rates. By geography, total US network revenue grew by 12%. The rest of the world business was down 10%, 8% when excluding FX. The quarter was negatively impacted by shipment timing in this quarter and elevated stocking in the comparable period last year.

回顧本季的業績驅動因素，首先是營業收入，總淨收入 2.99 億美元，無論以報告基礎或以固定匯率計算，都比去年同期成長 8%。按地區劃分，美國網路總收入成長了 12%。全球其他地區的業務下降了 10%，不包括外匯則下降了 8%。本季受到本季出貨時間以及去年同期庫存增加的負面影響。

SUBLOCADE net revenue outside of the US grew 30% year over year to $13 million in the quarter. Total SUBLOCADE net revenue was $192 million, up 24% versus Q2 of last year. As previously discussed, this was lower than we had expected due primarily to Medicaid disenrollment impacts, lower stocking levels, and delays in some newer CGS account activations.

本季度，SUBLOCADE 美國以外的淨收入年增 30%，達到 1,300 萬美元。SUBLOCADE 總淨收入為 1.92 億美元，比去年第二季成長 24%。如前所述，這一數字低於我們的預期，主要原因是醫療補助取消登記的影響、庫存水平較低以及一些較新的 CGS 帳戶激活延遲。

On a sequential basis, SUBLOCADE net revenue grew 7%, slightly ahead of dispenses given the destocking activity in Q1. For OPVEE, the net revenue in the quarter was minimal. For SUBOXONE Film, the average share of approximately 16% in the quarter was down compared with both the first quarter and the year-ago quarter as expected. As a reminder, we do not promote SUBOXONE Film in the US.

以環比計算，SUBLOCADE 淨收入成長 7%，由於第一季的去庫存活動，成長速度略高於分配速度。對 OPVEE 來說，本季的淨收入微乎其微。對於 SUBOXONE Film 來說，本季的平均份額約為 16%，與第一季和去年同期相比均有所下降，符合預期。提醒一下，我們不在美國推廣 SUBOXONE Film。

Moving down to P&L. Our second-quarter adjusted gross margin of 84% was up slightly versus the prior-year quarter, primarily reflecting favorable manufacturing variances and improved product mix from increased SUBLOCADE net revenue.

轉到損益表。我們第二季的調整後毛利率為 84%，較去年同期略有上升，主要反映了有利的製造差異和 SUBLOCADE 淨收入增加帶來的產品組合改善。

Adjusted SG&A expenses were $144 million in the quarter, an increase of 15% versus Q2 of last year, reflecting the incremental commercial investments we have made. R&D expenses were $27 million in the quarter. The decrease in R&D reflected phasing of expenses related to post-marketing studies for SUBLOCADE, partially offset by pipeline development efforts, which will accelerate into the second half of this year.

本季調整後的銷售、一般及行政費用為 1.44 億美元，較去年第二季成長 15%，反映了我們所做的增量商業投資。本季研發費用為 2,700 萬美元。研發費用的減少反映了 SUBLOCADE 上市後研究相關費用的分階段減少，但部分被管道開發工作所抵消，管道開發工作將在今年下半年加速。

Adjusted operating income of $79 million in the second quarter was up 11% versus the prior year. Lastly, on the P&L, our adjusted net income of $60 million grew 7% in the quarter, reflecting the dynamics I just highlighted.

第二季調整後的營業收入為 7,900 萬美元，較上年成長 11%。最後，在損益表中，我們本季的調整後淨收入為 6,000 萬美元，成長了 7%，反映了我剛才強調的動態。

Quickly touching on the balance sheet and our capital position. We ended the second quarter with gross cash and investments of $405 million. During the first half, positive cash flow from operations was offset by litigation-related payments and by our existing $100 million stock repurchase plan, which we expect to finish by the end of this month.

快速了解資產負債表和我們的資本狀況。截至第二季末，我們的總現金和投資為 4.05 億美元。上半年，經營活動產生的正現金流被訴訟相關付款和我們現有的 1 億美元股票回購計畫所抵消，我們預計該計畫將在本月底完成。

As Mark mentioned, today, we announced a new $100 million share repurchase program to reflect our confidence in the business. And we are provisioning $75 million for an agreed settlement for certain opioid litigation with the quantum agreed and payable over multiple years.

正如馬克所提到的，今天，我們宣布了一項新的 1 億美元股票回購計劃，以反映我們對業務的信心。我們也準備撥款 7,500 萬美元，針對某些鴉片類藥物訴訟達成和解，金額以雙方商定，分多年支付。

I would highlight that the $75 million provision will be remeasured once we reach final settlement with all the parties. The provision would then be reclassified to a liability, and the amount would be lowered to approximately $65 million by using a risk-adjusted rate versus a risk-free rate when discounting to the net present value.

我想強調的是，一旦我們與各方達成最終解決方案，將重新衡量 7,500 萬美元的撥備。然後，該準備金將被重新歸類為負債，並且在折現至淨現值時，使用風險調整利率而非無風險利率，金額將降低至約 6,500 萬美元。

Closing on our full-year 2024 guidance, which we updated on July 9, I want to highlight a few key takeaways. Our revised total net revenue guidance of $1.15 billion to $1.215 billion reflects the transitory headwinds we are facing in full year 2024 and at the midpoint represents 8% year-over-year growth. As we noted on the investor call on July 9, we expect to move beyond these items as the year progresses and especially as we look into 2025.

在結束我們 7 月 9 日更新的 2024 年全年指引時，我想強調幾個關鍵要點。我們修訂後的總淨收入指引為 11.5 億美元至 12.15 億美元，反映了我們在 2024 年全年面臨的暫時逆風，中間值代表著同比增長 8%。正如我們在 7 月 9 日的投資者電話會議上所指出的那樣，隨著時間的推移，特別是展望 2025 年，我們預計這些項目將會得到進一步的改進。

For SUBLOCADE, our guidance of $765 million to $805 million represents 25% year-over-year growth at the midpoint and keeps us on track to exit 2025 at $1 billion run rate and on a path to exceed $1.5 billion. For OPVEE, based on a slower than anticipated ramp, we recalibrated our net revenue expectations for full year 2024 to $9 million to $14 million. The majority of this reflects the BARDA order of approximately $8 million that we expect in the third quarter.

對於 SUBLOCADE，我們預計的 7.65 億美元至 8.05 億美元相當於中期同比增長 25%，並使我們預計在 2025 年底達到 10 億美元的營運規模，並有望超過 15 億美元。對於 OPVEE，基於低於預期的成長速度，我們將 2024 年全年淨收入預期重新調整為 900 萬美元至 1,400 萬美元。其中大部分反映了我們預計第三季 BARDA 約 800 萬美元的訂單。

Our guidance for film is unchanged. Our guidance for OpEx of $550 million to $560 million reflects a reduction of $25 million to $30 million versus prior expectations. This reduction includes the $20 million of anticipated cost savings relating to PERSERIS as well as lower volume-dependent expenses. Our guidance for R&D is unchanged.

我們對電影的指導保持不變。我們對營運支出的預期為 5.5 億美元至 5.6 億美元，與先前的預期相比減少了 2,500 萬至 3,000 萬美元。此次削減包括與 PERSERIS 相關的預計 2000 萬美元成本節省以及降低與數量相關的費用。我們對研發的指導保持不變。

Taking all the pieces together, we now expect adjusted operating income to be between $285 million and $320 million. At the midpoint, this implies solid year-over-year growth of 12% and an approximately 100-basis-point margin improvement.

綜合考慮所有因素，我們現在預計調整後的營業收入將在 2.85 億美元至 3.2 億美元之間。從中間值來看，這意味著年增 12%，利潤率提高約 100 個基點。

I will now turn the call back over to Mark.

現在我將把電話轉回給馬克。

Thanks, Ryan. Despite a challenging first half, I hope we demonstrate that we remain highly confident that the underlying fundamentals of our business and strategy remain intact and that we're on a path to help patients in this largely undertreated market while driving generating substantial shareholder value. We're happy to now take questions.

謝謝，瑞安。儘管上半年充滿挑戰，但我希望我們能夠證明我們仍然非常有信心，我們的業務和策略的基本面仍然完好無損，並且我們正在幫助這個治療不足的市場中的患者，同時努力創造可觀的股東價值。我們很高興現在回答問題。

Thank you, sir. (Operator Instructions) David Amsellem, Piper Sandler.

謝謝您，先生。（操作員指示）David Amsellem，Piper Sandler。

Hey, thanks. Just have a few. First, can you talk about what percent of new starts you're getting versus the competitor, Brixadi, and more importantly, how you're thinking about the mix between SUBLOCADE and Brixadi as we move through the second half of the year and into '25? That's number one.

嘿，謝謝。只吃幾個。首先，您能否談談與競爭對手 Brixadi 相比，您獲得的新開工百分比是多少？更重要的是，隨著我們進入今年下半年和 2025 年，您如何看待 SUBLOCADE 和 Brixadi 之間的組合？這是第一點。

Number two, looking at the guide for SUBLOCADE, can you talk about the extent to which it contemplates competitive headwinds related to Brixadi? In other words, does it just contemplate the disenrollments or does it contemplate competitive headwinds as well?

第二，請看一下 SUBLOCADE 的指南，您能否談談它在多大程度上考慮了與 Brixadi 相關的競爭阻力？換句話說，它是否只考慮取消註冊，還是也考慮競爭阻力？

And then lastly, just on the inventory, is that a statement on the competitive dynamics or is there something else going on there? Thank you.

最後，僅就庫存而言，這是對競爭動態的陳述還是有其他事情發生？謝謝。

Thanks, David. Let's start with the Brixadi question. And I think as we look to the market, we continue to see a market where nothing hinders our conviction behind our belief that SUBLOCADE is a paradigm shift in treatment. And we don't see other products that match the offering, especially in a market where the opioid epidemic has transitioned to Fentanyl and other highly powered synthetic opioids.

謝謝，大衛。讓我們從 Brixadi 問題開始。我認為，當我們放眼市場時，我們將繼續看到這樣一個市場：沒有什麼可以阻礙我們堅信 SUBLOCADE 是治療領域的典範轉移。而且我們還沒有看到其他產品能與該產品相媲美，特別是在阿片類藥物氾濫已轉向芬太尼和其他高效合成阿片類藥物的市場中。

This is further reinforced. And to your question, David, that we're seeing four out of five new patients are choosing SUBLOCADE. So a significant patient choice as new patients are coming into treatment.

這一點得到了進一步的強化。關於你的問題，大衛，我們看到五分之四的新病人都選擇了 SUBLOCADE。因此，當新患者接受治療時，患者的選擇非常重要。

With regards to the guide, the guide, we have an extreme confidence with regards to what we've guided on SUBLOCADE, and that includes all the factors we currently see in the market, the transitory issues as well as competitive pressures. And if you could repeat your third question, I missed it when you asked it.

關於指南，我們對我們在 SUBLOCADE 上所指導的內容非常有信心，其中包括我們目前在市場上看到的所有因素、暫時性問題以及競爭壓力。如果您可以重複您的第三個問題，那麼當您問這個問題時我錯過了。

Yeah, sure. On the inventory, just the lower stocking levels, is that a statement on the competitive dynamics? Or is there something else going on there?

是的，當然。就庫存而言，庫存水準較低，這是對競爭動態的一種說明嗎？還是那裡還有其他事情發生？

Thank you. I'll hand that to Ryan.

謝謝。我會把它交給瑞安。

Yeah. No, that's a good question. And at this point, we believe it's a one-time reset as we get through 2024 primarily driven by -- as we become more focused on these OHS larger networks, they tend to be able to streamline their order pattern. So the turns that the wholesalers have become lower, which then has the byproduct of requiring less stocking at this point.

是的。不，這是個好問題。目前，我們認為這是一個一次性的重置，因為我們將進入 2024 年，主要原因是 - 隨著我們更加關注這些 OHS 大型網絡，它們往往能夠簡化其訂單模式。因此批發商的周轉率變低，其副產品就是此時所需的庫存減少。

Okay. If I may just sneak in one follow-up just on net pricing, net realized price over time, with a two player LAI market now, how do you think about the trajectory of net price, not just for this year, but also as we move through next year? Thanks.

好的。如果我可以偷偷跟進淨定價、淨實現價格隨時間的變化，現在 LAI 市場有兩個參與者，您如何看待淨價格的走勢，不僅是今年，還有明年的走勢？謝謝。

Yeah, I think we'll probably guide on '25 in February. But what we see now is on an absolute pricing basis is it's incredibly stable. And any of the sort of variances, I think, that folks would be modeling are going to be more mix related as the channel sort of mix shift through time.

是的，我想我們可能會在二月指導‘25’。但我們現在看到的是，從絕對定價來看，它非常穩定。我認為，隨著渠道組合隨著時間的推移而變化，人們所建模的任何一種差異都將與組合更加相關。

And David, let me just say a bit remiss, I probably should have started with this. Welcome to coverage. Saw the initiate this week. Thanks for joining.

大衛，我有點疏忽了，我可能應該從這個開始。歡迎收看報道。本週看到了啟動。感謝您的加入。

All right. Happy to be here and I'll jump back in the queue. Thanks, guys.

好的。很高興來到這裡，我會重新回到隊列中。謝謝大家。

Paul Cuddon, Deutsche Numis.

保羅‧卡登 (Paul Cuddon)，《德意志錢幣》。

Good morning, guys. Just two questions from me, please. Just noting the success in the alternate sites of care between Q1 and Q2, I'm just wondering if you could elaborate on those five partners. What exactly is working well there and are they exclusive relationships?

大家早安。請問我兩個問題。只是注意到 Q1 和 Q2 之間替代護理站點的成功，我只是想知道您是否可以詳細說明這五個合作夥伴。那裡究竟什麼運作良好？它們是獨家關係嗎？

And there has been -- secondly, just for me on uncertainty over the impact of Medicaid disenrollments, you had a peer with high Medicaid sales and site, but they hadn't seen any impact. So I'm just wondering if you could just help me quantify the impact that you have seen and why that might be different. Thank you.

其次，就我對醫療補助取消註冊的影響的不確定性而言，您有一個擁有高醫療補助銷售額和站點的同行，但他們沒有看到任何影響。所以我只是想知道您是否可以幫助我量化您所看到的影響以及為什麼可能會有所不同。謝謝。

Certainly. So with regards to a [ASOC], yeah, we are really pleased with that and the progress that we've had and continue to have. And just to remind everyone, this is something that's going to take quarters and years to build out a nationwide network to open this up for these independent physicians who've previously been held out because of the administrative burden of a specialty pharmacy product.

當然。所以關於 [ASOC]，是的，我們對此感到非常高興，並且對我們已取得的並將繼續取得的進展感到非常高興。需要提醒大家的是，建立一個全國性的網絡需要花費幾個季度甚至幾年的時間，以便為那些之前因為專科藥品的管理負擔而被拒之門外的獨立醫生開放這項服務。

So we now have over 12,000 locations across 22 states with five partners and seen injection growth that will grow over 55% as we're able to start calling on these independent physicians and be able to highlight that there are those local pharmacies there is very important. So very excited about over 1,200 locations.

因此，我們現在在 22 個州擁有超過 12,000 個門市，擁有 5 個合作夥伴，注射劑的成長率將超過 55%，因為我們能夠開始聯繫這些獨立醫生，並且能夠強調那些當地藥局非常重要。我對超過 1,200 個地點感到非常興奮。

With regards to the Medicaid re-enrollment, I can't speak to other people's business. But what I can say is we spent an immense amount of time diagnosing our business and where we are. And what we've seen with the waves of both the Change Healthcare and the re-enrollments is we've seen a major shift in our retention curves that have fluctuated through time that we believe have impacted our business of the $60 million reduction on SUBLOCADE about $30 million or about 5% growth year over year.

關於醫療補助重新登記的問題，我不能談論別人的事。但我可以說的是，我們花了大量的時間來診斷我們的業務和我們所處的位置。隨著醫療變革和重新註冊浪潮的到來，我們的保留曲線發生了重大轉變，隨著時間的推移，這種轉變一直在波動，我們認為這對我們的業務產生了影響，SUBLOCADE 減少了 6000 萬美元，比去年同期減少了約 3000 萬美元，或增長了約 5%。

I still do have to highlight, we're still forecasting that we're going to grow over 25% on SUBLOCADE year over year. So while a bit slower than we expected because of the transitory issues, we're still seeing significant growth and are excited about the fact that we are receiving four out of five new patients.

我仍然需要強調的是，我們仍然預測 SUBLOCADE 的年成長率將超過 25%。因此，雖然由於暫時性問題，速度比我們預期的要慢一些，但我們仍然看到了顯著的增長，並且對我們接收了五分之四的新患者這一事實感到興奮。

Super. Thank you very much.

極好的。非常感謝。

Chase Knickerbocker, Craig-Hallum.

蔡斯·尼克博克、克雷格·哈勒姆。

Good morning, everyone. Thanks for taking the questions. So just starting on SUBLOCADE, just to kind of work off a question that David had asked. So you had said kind of when we were originally doing 2024 guidance that -- and with the update earlier this month that the competitive kind of headwind, so to say, was kind of in line with your expectations when you had originally guided.

大家早安。感謝您回答這些問題。因此，我們剛開始研究 SUBLOCADE，只是為了解答 David 提出的一個問題。所以，當我們最初制定 2024 年指引時，您曾說過——根據本月早些時候的更新，競爭逆風與您最初指引時的預期是一致的。

Can you kind of walk us through what it assumes from kind of new patient starts from your competitor in the second half of the year? Does your guide assume that those new patient starts for your competitor or kind of ramp up further from the 21% that I think you referenced earlier? Just kind of benchmarking us on guidance for the second half there.

您能否向我們介紹一下，從今年下半年競爭對手開始接收新病患的情況來看，情況是如何的？您的指南是否假設這些新患者是為您的競爭對手開始治療的，或者從您之前提到的 21% 進一步上升？這只是對我們下半年的指導進行基準測試。

Yeah, Chase. We don't provide guidance on all kind of the leading and lagging KPIs. I think the key part here is we've given a guidance range for the balance to go that we had extreme confidence in. We highlighted at the interim update that the transitory nature, that the transitory items have made it more difficult to forecast what the move forward on a quarter-to-quarter basis, but we have confidence in the range on the year that will achieve that.

是的，蔡斯。我們不提供所有類型的領先和滯後 KPI 的指導。我認為這裡的關鍵部分是，我們給了一個我們非常有信心的平衡指導範圍。我們在中期更新中強調了暫時性，暫時性項目使得預測季度間變動變得更加困難，但我們對全年實現這一目標的範圍充滿信心。

Got it. And then maybe just one for Jeff, if he's on the call here, on the new provision. So obviously, quite a few points that's kind of around the opioid MDL items. Can you just kind of help us clarify with this preliminary settlement kind of what you would expect it to settle when it comes to the opioid litigation? Is this kind of a wholesome potential preliminary settlement or just kind of help us there?

知道了。如果傑夫在場的話，也許他只需要談一點新規定的內容。顯然，有相當多的觀點都與阿片類藥物 MDL 計畫有關。您能否幫助我們澄清一下，在鴉片類藥物訴訟中，您期望透過初步和解解決什麼問題？這是一種有益的潛在初步解決方案嗎？還是僅僅對我們有幫助？

Yeah, sure, Chase. Thanks for the question. So the settlement is -- potential settlement as with the municipalities and tribal nations, which if you look at our Note 13, when we talk about that, about one-third of the cases are private plaintiffs and two-thirds of those 400 cases are municipalities and tribal nations. So we would expect it to settle and put those cases with the municipalities behind us.

是的，當然，蔡斯。謝謝你的提問。因此，和解是 - 與市政當局和部落國家之間的潛在和解，如果你看一下我們的註釋 13，當我們談論這個問題時，大約三分之一的案件是私人原告，而這 400 個案件中的三分之二是市政當局和部落國家之間的和解。因此，我們希望此事能夠得到解決，並將這些與市政當局的案件拋諸腦後。

Got it. And then just last one. We haven't really talked about it too much with kind of all the recent items. Maybe just speak to kind of how the reception's been from potential customers relative to what your original expectations were. And then kind of just the main drivers for kind of the revision in expectations that we've seen recently. And then a little bit more context, if you would, on kind of the pushback that you're receiving from some harm reduction advocates. Thanks for the questions.

知道了。然後是最後一個。我們實際上並沒有就最近的所有事情談論太多。也許只是談談潛在客戶的回饋與您最初的期望相比如何。這就是我們最近看到的預期修正的主要驅動因素。然後，如果可以的話，請您再稍微介紹一下您從一些減少傷害倡導者那裡得到的反對意見。感謝您的提問。

Yeah. Thank you, Chase. And what I'd say is I'll maybe I'll start with your last point and then build that into what we're seeing. I think the pushback that we're seeing from certain harm reduction folks has been larger than we would expected. We have a medication here that we believe is very suited for this synthetic opioids that have overtaken the drug supply that are causing poisoning of non-addictive people as well as overdoses of those that are choosing to recreationally use opioids.

是的。謝謝你，蔡斯。我想說的是，我可能會從你的最後一點開始，然後將其融入我們所看到的內容中。我認為，我們看到的來自某些減少危害人士的反對比我們預期的要大。我們有一種藥物，我們認為它非常適合這種合成阿片類藥物，這種藥物已經超過了藥物供應，導致非成癮人群中毒以及選擇娛樂性使用阿片類藥物的人過量服用。

And we believe that now nalmefene is a breakthrough paradigm shift for these folks, and it's the only one specifically called out for synthetic opioids on the label. So we've seen a stronger-than-expected voice from harm reduction who have a fear of precipitated withdrawal. And obviously, that's not been studied in market, which makes it tough.

我們相信，納美芬現在對這些人來說是一個突破性的範式轉變，而且它是唯一一種在標籤上特別指出的合成鴉片類藥物。因此，我們看到來自減害組織的呼聲比預期的更強烈，他們擔心人們會突然退出。顯然，這在市場上還沒有被研究過，這使得問題變得困難。

I mean, from our standpoint, what we're doing is helping drive experience through our experience program. As we mentioned at the interim results, we have over 170 activations of new experience programs where people are able to get product and use it.

我的意思是，從我們的角度來看，我們正在做的是透過我們的體驗計劃來幫助推動體驗。正如我們在中期業績中提到的那樣，我們已啟動超過 170 個新體驗計劃，人們可以獲得產品並使用它。

I think for me, the extreme positive there is that as people are getting this product and using it, the average units used in our initial pilot up in Michigan was 1.2 units. So you're using less units. It's a simpler rescue. And it's acting exactly as we'd expected with differentiation versus Narcan in the initial samples.

我認為，對我來說，最大的積極因素是，隨著人們購買並使用此產​​品，我們在密西根州的初始試點中平均使用的單位為 1.2 個單位。因此您使用的單位較少。這是一次更簡單的救援。它的表現正如我們預期的那樣，與初始樣本中的 Narcan 有明顯區別。

Now we have to translate that into real-world evidence that we can use with customers. But we expect through time that the experience program, the in-market performance will translate into sales to customers and in line with our expectations.

現在我們必須將其轉化為可供客戶使用的真實證據。但我們預計，隨著時間的推移，體驗計劃和市場表現將轉化為客戶銷售額，並符合我們的預期。

Thanks, guys.

謝謝大家。

Thank you, Chase.

謝謝你，蔡斯。

Thibault Boutherin, Morgan Stanley.

摩根士丹利的 Thibault Boutherin。

Yes, thank you very much. My first question is on the average number of dispensed per patient. So we see the number of patients increasing faster than the number of distance. And if we do a very [good] math on the average dispensed a patient, that number's been coming down for a number of quarters. Just wanted to know if you could help us understand what this means? I interpret this as a faster turnover of the patient population. So in average, lower duration of treatments.

是的，非常感謝。我的第一個問題是關於每個病人平均配藥數量。因此，我們看到患者數量的增長速度快於距離數量的增長速度。如果我們對平均每位病人的診療次數做一個非常好的統計，就會發現這個數字已經連續幾個季度下降了。只是想知道您是否可以幫助我們理解這意味著什麼？我將此解讀為患者群體的更快流動。因此平均而言，治療時間較短。

First of all, is this correct? And so is it related to the Medicaid disruption of your patient base? And so could we expect the average number of dispensed per patient coming back up as we get out of the Medicaid disruption? So that's the first question.

首先，這是正確的嗎？那麼這是否與醫療補助對病患群體的干擾有關？那麼，當我們擺脫醫療補助中斷時，我們是否可以預期每位病患的平均配藥數量會回升？這是第一個問題。

And second question on the share buyback, could there be any potential technical constraints here because you're buying a large proportion of the outstanding shares over a relatively short amount of time? So just wanted to know if you could potentially run into any technical limitation.

關於股票回購的第二個問題，由於您在相對較短的時間內購買了大量流通股，因此是否有任何潛在的技術限制？所以只是想知道您是否可能遇到任何技術限制。

And then last question on the opioid -- civil opioid agreement. So can you just clarify that all public entities have been dealt with and so the remaining ones are only kind of private individual claims? And also, if you could give us any insight into where you are in managing this remaining individual claims for the similar MDR. Is it possible to see potentially also settlements dealing with all of these at the same time at some points? Thank you.

最後一個問題是關於鴉片類藥物—民事阿片類藥物協議。那麼，您能否澄清一下，所有公共實體都已處理，其餘的只是私人索賠？此外，如果您能向我們介紹一下您在管理類似 MDR 的剩餘個人索賠方面的情況，我們能提供什麼資訊嗎？是否有可能在某些時候看到潛在的解決方案同時處理所有這些問題？謝謝。

If you could just repeat the end of your last question, please, Thibault. It broke up a little bit. I heard the portion on the opioid MDL public versus individual or what we would call more product-related neonatal. What was the second part of that where you broke up?

蒂博，請重複你上一個問題的結尾。它有點破碎了。我聽說了有關阿片類藥物 MDL 公眾與個人的部分，或者我們稱之為更多與產品相關的新生兒的部分。你們分手後的第二部分是怎麼樣的？

The second part was just if you could give us any insight on where you are managing these claims, so if you could also see a potential settlement at some points.

第二部分是，您是否可以向我們介紹您如何處理這些索賠，以及您是否可以在某些時候看到潛在的解決方案。

Thank you for that. Sorry, you broke up. So I'll handle the first and I'll ask Ryan to handle the share buyback, and then just let Jeff talk through the nuances of the opioid MDL, which is, again a preliminary settlement agreement on quantum with more to come on the exact details of papering.

謝謝你。抱歉，分手了。因此，我將處理第一項事務，並讓瑞安處理股票回購，然後讓傑夫講解阿片類藥物 MDL 的細微差別，這又是一項關於量子的初步和解協議，後面還會詳細介紹文件的具體細節。

So when it comes to the average number of dispenses, I think you virtually have answered your own question, Thibault, is you are seeing a little bit of a disconnect on patient growth versus dispenses. And you indicated a faster turnover. I think it is due to that retention curve shift that we saw associated with Change Health, associated with the Medicaid disenrollment where we're seeing patients out of treatment faster.

因此，當涉及平均配藥次數時，我認為您實際上已經回答了您自己的問題，Thibault，您是否看到患者增長與配藥次數之間存在一些脫節。您也表示週轉速度更快。我認為這是由於我們看到的與 Change Health 相關的保留曲線轉變，與醫療補助取消相關，我們看到患者更快退出治療。

Our expectation is that that retention curve will shift back to what's been a very consistent retention curve for the past four years. So we expect that as the transitory issues ease to come back and we can reconnect, so to speak, moving forward.

我們的預期是，留存曲線將恢復到過去四年非常穩定的留存曲線。因此，我們預計，隨著暫時性問題的緩解，我們可以重新連結起來，可以這麼說，繼續前進。

So with that, on the SUBLOCADE dynamics, Ryan, do you want to talk about the technical constraints that -- with regards to the buyback that Thibault was asking?

那麼，關於 SUBLOCADE 動態，Ryan，你想談談 Thibault 要求的回購方面的技術限制嗎？

Yeah, so the plan is to first wrap up the current program as soon as possible. We anticipate that end of July, early August, and then start this new program right after that. We have a plan of front-loading that to certainly take advantage in the disconnect in the share price and have a structure in place to have it last over six months.

是的，所以計劃是先盡快完成目前的計劃。我們預計在七月底、八月初，然後立即啟動這個新計畫。我們有一個前期投入計劃，可以充分利用股價的脫節，並建立一個可以持續六個月以上的結構。

In regards to any constraints, we certainly have to abide by more trading rules. And the most common one is if the share price is 5%, the -- above the five-day average, we do have to halt purchases at that point. That's something that's happened in the past and something that we will have to adhere to going forward.

對於任何限制，我們當然必須遵守更多的交易規則。最常見的情況是，如果股價高於五天平均 5%，我們就必須停止購買。這是過去發生的事情，也是我們今後必須堅持的事情。

Thanks, Ryan. Jeff, do you want to talk to the opioid MDL?

謝謝，瑞安。傑夫，你想和阿片類藥物 MDL 談談嗎？

Yeah, let me move this microphone a little closer to me. I really appreciate the questions. So first, I didn't say this to Chase, but I just wanted to make sure everybody understands. We are really pleased to have reached an agreement on the quantum for the settlement because we do believe it will ultimately put the municipality litigation substantially behind us. Obviously, we still have to negotiate the final material terms, but we have reached that agreement with the Plaintiffs' Executive Committee and certain states' Attorney General.

是的，讓我把這支麥克風移近一點。我非常感謝這些問題。所以首先，我沒有對蔡斯說這個，但我只是想確保每個人都明白。我們非常高興就和解金額達成協議，因為我們確實相信這最終將使我們擺脫市政訴訟的困擾。顯然，我們仍需就最終的實質條款進行談判，但我們已經與原告執行委員會和某些州的司法部長達成了協議。

I think you'd asked a question about the private plaintiffs. So as it relates to private plaintiffs, those cases are very early in their stage, right? They've all been stayed. There has been little to no activity on them. You should view those claims. I think, as Mark mentioned, more along the lines of a product liability claim. But because they're in the very early stage, we have only begun our evaluation of the claims. Obviously, we believe we have meritorious defenses and we intend to vigorously defend ourselves in these private plaintiff actions.

我認為你問的是有關私人原告的問題。那麼，就私人原告而言，這些案件還處於早期階段，對嗎？他們都被留下來了。它們幾乎沒有任何活動。您應該查看這些聲明。我認為，正如馬克所提到的，這更像是產品責任索賠。但由於尚處於早期階段，我們才剛開始評估這些說法。顯然，我們相信我們有充分的辯護理由，並且我們打算在這些私人原告訴訟中積極為自己辯護。

And then lastly, we do expect and would plan on fulsome participation from municipalities in the cases. So we would expect fulsome participation. But until we get to final settlement terms, we won't know how that's going to play out.

最後，我們確實期望並計劃讓各市政當局充分參與這些案件。因此我們期待大家的充分參與。但直到我們達成最終解決方案之前，我們不知道事情會如何發展。

Thanks, Jeff.

謝謝，傑夫。

Thank you.

謝謝。

Max Herrmann, Stifel.

馬克斯·赫爾曼（Max Herrmann），Stifel。

Great. Thanks for taking my questions. I've got a couple, if I may. Firstly, just in terms of looking towards the cannabis use disorder AEF0117 data in September. What should we be looking for in terms of where do you see success in terms of the clinical outcomes? Obviously, conscious that you then have to wait to the end of Phase 2 meeting with the FDA and make a decision on whether to exercise your option. So that's the first question.

偉大的。感謝您回答我的問題。如果可以的話，我有幾個。首先，僅就 9 月的大麻使用疾患 AEF0117 數據而言。就臨床結果而言，您認為我們應該尋找什麼成功之處？顯然，您必須等到與 FDA 的第二階段會議結束，然後決定是否要行使您的選擇權。這是第一個問題。

The second is just a bit more clarity on the -- I guess the third of the case -- the cases, I think you talked about 400 cases in the MD -- the opioid MDL and third private cases. What is that case? Because obviously, I thought the basis of most of these cases was to do with use of opioids for treatment of pain in individuals. What are the cases that they have got against Indivior then?

第二點只是想更清楚地了解一下——我想是第三個案例——這些案例，我想你談到了 MD 中的 400 個案例——阿片類藥物 MDL 和第三個私人案例。那是什麼情況？因為很明顯，我認為大多數此類病例的基礎與使用鴉片類藥物治療個人疼痛有關。那麼他們針對 Indivior 提出了哪些訴訟呢？

Thanks for those questions, Max. I'm going to go ahead and start with Christian to talk about the end of the Phase 2 results and meeting with the FDA, and then I'll ask Jeff to talk a little bit more color on those remaining cases that aren't part of the settlement.

謝謝你的提問，馬克斯。我首先要和克里斯蒂安討論第二階段的結果以及與 FDA 的會面，然後我會請傑夫更詳細地談談那些不屬於和解範圍的剩餘案件。

Hi, Max. So as you know, I cannot comment clearly on the reserves at this stage. The study is complete. We are currently looking the database. And over the next several weeks and couple of months, we are going to thoroughly curate the data, analyze the data, and interpret the data. So we are currently on track to have top-line results in September.

你好，馬克斯。所以如你所知，我目前無法對儲備做出明確評論。研究已完成。我們目前正在查看資料庫。在接下來的幾週和幾個月裡，我們將徹底整理數據、分析數據並解釋數據。因此，我們目前預計在 9 月取得營收成果。

Following these top-line results, we will then prepare the submission to the FDA. This is a pretty substantial submission to the FDA in order to organize an end-of-Phase 2 meeting with the agency before the end of the year. And then it is, as Mark mentioned, the combination of the data of the Phase 2b study as well as the feedback from the FDA and the end of Phase 2 meeting, it will help us to make the decision as to whether or not we exercise the option of these assets in the first quarter next year.

根據這些最重要的結果，我們將準備向 FDA 提交文件。這是一份向 FDA 提交的相當重要的文件，目的是在年底前與該機構組織第二階段結束會議。然後，正如馬克所提到的，2b 期研究的數據以及 FDA 的回饋和 2 期會議的結束，將幫助我們決定是否在明年第一季行使這些資產的選擇權。

Yeah, I think the key on that one, Max, is it is truly like a lock and key. The results will come out and they'll be what they are versus the endpoint in the Phase 2, which was an 80% reduction. But that will then inform a dialogue with the FDA with regards to a potential Phase 3 and what those endpoints would be, which could differ from the Phase 2. So truly, you have to first see the results. And then you have to have the discussion with the FDA. And only the two of those when added with the market research on what do we mean commercially will inform the option.

是的，馬克斯，我認為這個的關鍵就在於它真的就像一把鎖和一把鑰匙。結果將會出來，與第二階段的終點相比，結果將會是 80% 的減少。但這將會為與 FDA 就潛在的第 3 階段及其終點進行對話提供信息，這些終點可能與第 2 階段不同。所以說實話，你必須先看到結果。然後你必須與 FDA 進行討論。只有將這兩者與市場研究結合起來，從商業角度來判斷，我們才能做出正確的選擇。

Jeff, could you please speak to the remaining cases?

傑夫，你能談談剩下的案件嗎？

Yeah, sure, Mark. And Max, so your question is what about the individual plaintiffs, the private plaintiffs? Most of them are asserting claims for what is called a neonatal abstinence syndrome. So these would be mothers or family members that have sued alleging that a child was born with an addiction to opioids, and we have been named in a number of those lawsuits.

是的，當然，馬克。馬克斯，你的問題是，個人原告、私人原告的情況如何？他們中的大多數人都在主張所謂的新生兒戒斷症候群。這些人可能是母親或家人，他們聲稱孩子出生時就對鴉片類藥物上癮，而我們在多起訴訟中都有涉案。

So this would be individuals who were taking SUBOXONE. And as a result of that treatment, then they're -- in pregnancy, the child was born addicted to opioids?

這些人都是服用 SUBOXONE 的人。而且由於這種治療，他們在懷孕期間，孩子出生時就對鴉片類藥物上癮了？

Yeah, Max, I would maybe characterize it as they allege they take SUBOXONE Film. That's part of the issue, right? These are very early in their stages. So we don't really have a lot more information than they filed the claims. But yes, the allegations would be that they took some product that we had and that the child was born with neonatal abstinence syndrome.

是的，馬克斯，我可能會將其描述為他們聲稱服用了 SUBOXONE Film。這是問題的一部分，對吧？這些都還處於非常早期的階段。因此，我們實際上掌握的資訊並不比他們提出的索賠多。但是的，指控是他們拿走了我們的一些產品，並且孩子出生時患有新生兒戒斷症候群。

Okay. Thank you.

好的。謝謝。

Thank you, Max.

謝謝你，馬克斯。

(Operator Instructions) Paul Cuddon, Deutsche Numis.

（操作員說明）Paul Cuddon，Deutsche Numis。

Yeah, thank you, guys. I just got a couple of follow-up questions, if I may. Just firstly, now there are two companies or at least two companies out there promoting kind of long-acting injectables for opioid use disorder. I mean, are you starting to see any new clients come on board then getting in contact with you to ask about the potential benefits of SUBLOCADE that you may not have activated yourself?

是的，謝謝大家。如果可以的話，我只想問幾個後續問題。首先，現在有兩家公司或至少兩家公司正在推廣用於治療鴉片類藥物使用疾患的長效注射劑。我的意思是，您是否開始看到有新客戶加入，然後與您聯繫，詢問您可能尚未啟動的 SUBLOCADE 的潛在好處？

And then secondly, for me, a question for Christian on the start of the longer-acting product. Once you've shown the 2 nanograms per mil for 90 days, I mean, what really would there be sort of needed to do to get that product through into kind of more kind of pivotal studies? Thank you.

其次，我有個問題想問克里斯蒂安，關於長效產品的開始。一旦你證明了 90 天內每毫升含 2 奈克，我的意思是，真正需要做什麼才能讓產品進入更關鍵的研究階段？謝謝。

Maybe I'll handle the first one, and then I'll ask Christian to talk through the longer-acting. Listen, I think our belief has always been that when you look at this disease space, the high unmet need that's out there, less than 2 and 10 people in treatment, there is a huge role to play for long-actings and certainly plenty of room for multiple people to participate.

也許我會先處理第一個，然後再請克里斯蒂安討論長效版本。聽著，我認為我們始終堅信，當你觀察這個疾病領域時，你會發現那裡存在著大量未滿足的需求，接受治療的人不到 2 到 10 人，長效藥物可以發揮巨大的作用，而且肯定有足夠的空間讓多人參與。

Our expectation is that the increased share of voice for long-actings will actually drive market growth in the medium and long term as we continue to help more patients. And I think as I detailed in my prepared comments, what we are seeing is continued strong HCP and patient growth that are active prescribers. So now we're over 7,000 active prescribers of SUBLOCADE. So we continue to see good growth and see it that we're in the early days because we only have about a 6% penetration of LAIs in the market, though excited about the bright future ahead.

我們的預期是，隨著我們繼續幫助更多的患者，長效藥物的市場份額增加實際上將在中長期推動市場成長。我認為，正如我在準備好的評論中詳細說明的那樣，我們看到的是積極開處方的 HCP 和患者數量持續強勁增長。因此，現在我們有超過 7,000 名 SUBLOCADE 的活躍處方者。因此，我們繼續看到良好的成長，並看到我們處於早期階段，因為我們在市場上的 LAI 滲透率僅為 6% 左右，儘管我們對未來的光明前景感到興奮。

Christian, you want to speak to the Alar partnership?

克里斯蒂安，你想和阿拉爾合夥公司談談嗎？

(technical difficulty) a pretty good understanding on the pharmacokinetics of a 3-month LAI with buprenorphine using the -- a larger delivery platform. This is based, however, on a single dose study. So the next step for us is to organize with the goal on multiple dose pharmacokinetics study to really inform us and understanding the pharmacokinetics properties of these new products in order to then organize a meeting with the FDA before we embark on a pivotal Phase 3 trials.

（技術難度）使用更大的傳輸平台，對 3 個月 LAI 與丁丙諾啡的藥物動力學有相當好的理解。但這是基於單一劑量研究。因此，我們的下一步是組織多劑量藥物動力學研究，以真正了解和理解這些新產品的藥物動力學特性，然後在我們開始關鍵的 3 期試驗之前組織與 FDA 的會議。

Okay. Thank you.

好的。謝謝。

Thank you, Paul.

謝謝你，保羅。

Thank you. We have no further questions at this time. I will now hand back to Mark for closing remarks. Thank you.

謝謝。目前我們沒有其他問題。現在我將把發言交還給馬克，請他作最後發言。謝謝。

Thank you, [Rosen]. With no more questions, this will conclude our second quarter half one results presentation. I'd like to thank everyone for their continued interest in Indivior, and we look forward to updating the market as we progress. Have a great day.

謝謝你，[羅森]。如果沒有其他問題，我們的第二季上半年業績報告就到此結束。我要感謝大家對 Indivior 的持續關注，我們期待在進步的同時更新市場。祝你有美好的一天。