Indivior PLC (INDV) 2023 Q1 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Indivior PLC Q1 2023 Financial Results Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded.

美好的一天，感謝您的支持。歡迎參加 Indivior PLC 2023 年第一季財務業績電話會議。 （操作員指示）請注意，今天的會議正在錄製中。

I would now like to hand the conference over to your host today, Jason Thompson. Please go ahead, sir.

我現在想把會議交給今天的東道主傑森湯普森。請繼續，先生。

Thanks, Sharon, and good morning, good 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 the factors that may cause our results to be materially different on Slide 2. We also may refer to non-GAAP measures, the reconciliations for which may be found in the appendix to the presentation that is now posted on our website at indivior.com.

謝謝莎倫，大家早安，下午好。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。我們在投影片 2 中列出了可能導致我們的結果出現重大差異的因素。我們也可能會參考非 GAAP 衡量標準，其調整可在現已發佈在我們網站上的簡報的附錄中找到。 com .

I'll now turn the call over to Mark Crossley, our Chief Executive Officer.

我現在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, good afternoon, everyone. Thanks for joining our first quarter results call. Here with me today are Ryan Preblick, our Chief Financial Officer; and Christian Heidbreder, our Chief Scientific Officer.

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

I'll start the call with an overview of the results for Q1 and a progress report against our strategic priorities. Ryan will then provide more detail on the first quarter results and updated fiscal year 2023 guidance. And then following that, we'll move to Q&A.

我將首先概述第一季的結果以及針對我們的策略重點的進度報告。隨後，瑞安將提供有關第一季業績和更新的 2023 財年指導的更多詳細資訊。接下來，我們將進入問答環節。

Turning to the key messages, we delivered an excellent start to 2023 driven by strong execution against our profitable growth strategy, which is primarily focused on increasing SUBLOCADE's prescriber depth within our organized health systems.

談到關鍵訊息，我們在獲利成長策略的強有力執行的推動下，在 2023 年取得了良好的開端，該策略主要側重於增加 SULOCADE 在我們有組織的衛生系統中的處方者深度。

Our first quarter total net revenue grew 22% led by SUBLOCADE. The strength of our top line allowed us to absorb incremental growth investments behind SUBLOCADE in the U.S. justice system channel while still delivering operating leverage. As a result, our adjusted operating profit grew 31% in the quarter.

在 SUBLOCADE 的帶動下，我們第一季的總淨收入成長了 22%。我們的營收實力使我們能夠吸收美國司法系統管道 SUBLOCADE 背後的增量成長投資，同時仍提供營運槓桿。因此，本季調整後的營業利潤成長了 31%。

We also successfully completed the acquisition of Opiant at the beginning of March. This important strategic step strengthens our addiction portfolio with the addition of OPNT003, which we expect to become the next generation agent for opioid overdose reversal subject, of course, to regulatory approval by the FDA.

我們也在3月初成功完成了對Opiant的收購。這一重要的策略步驟透過增加 OPNT003 加強了我們的成癮產品組合，我們預計 OPNT003 將成為阿片類藥物過量逆轉受試者的下一代藥物，當然，這需要獲得 FDA 監管部門的批准。

I'm also pleased to report that we fully integrated the Opiant commercial and R&D teams. And with our combined experiences, capabilities and footprint, our teams have hit the ground running as we prepare for potential FDA approval and then launch.

我還很高興地報告，我們完全整合了 Opiant 商業和研發團隊。憑藉我們的綜合經驗、能力和足跡，我們的團隊已經開始著手準備潛在的 FDA 批准並隨後啟動。

You'll also know that we've updated our fiscal year 2023 guidance for the Opiant acquisition as well as our updated share assumptions for film. As a result, we've increased our fiscal year 2023 net revenue expectations. Ryan will share more detail on these and other fiscal year 2023 guidance items in a moment.

您還會知道，我們更新了 Opiant 收購的 2023 財年指導以及更新的電影份額假設。因此，我們上調了 2023 財年的淨收入預期。 Ryan 稍後將分享有關這些以及其他 2023 財年指導項目的更多詳細資訊。

Finally, a quick note on the legacy litigation, which I know is top of mind among our stakeholders. While I'm constrained in what I can say due to the ongoing nature of these matters before the court, I can confirm that discussions continue with the parties as we actively try to bring greater certainty for our shareholders at an appropriate value. Doing so will allow us to focus all of our efforts on meeting the important needs of patients suffering from substance use disorders and serious mental illness.

最後，簡單說明遺留訴訟，我知道這是我們的利害關係人最關心的問題。雖然由於這些事項正在法庭上審理，我的發言受到限制，但我可以確認，隨著我們積極努力以適當的價值為我們的股東帶來更大的確定性，與各方的討論仍在繼續。這樣做將使我們能夠集中精力滿足患有藥物濫用障礙和嚴重精神疾病的患者的重要需求。

Moving next to our report card for the first quarter, we continue to make excellent progress against our strategic priorities. First SUBLOCADE net revenue of $132 million grew 12% versus the previous quarter and 55% versus Q1 last year.

接下來是第一季的成績單，我們繼續在策略重點方面取得出色進展。 First SUBLOCADE 淨收入為 1.32 億美元，較上一季成長 12%，比去年第一季成長 55%。

Sequential dispense growth was 16%. This strong double-digit performance was driven by our ongoing strategy to increase prescribing depth in the 500-plus organized health systems that we've accessed. Organized health systems now account for approximately 80% of SUBLOCADE's growth. Additionally, we saw an increased contribution to SUBLOCADE net revenue from the U.S. justice system channel as more facilities were activated.

連續分配成長率為 16%。這種強勁的兩位數業績是由我們持續實施的策略所推動的，該策略旨在增加我們所訪問的 500 多個有組織的衛生系統的處方深度。目前，有組織的衛生系統約佔 SUBLOCADE 成長的 80%。此外，隨著更多設施的啟用，我們發現美國司法系統管道對 SUBLOCADE 淨收入的貢獻增加。

You'll also note that SUBLOCADE patients at the end of the first quarter were approximately 95,000. This is just over 1/3 of the way toward the estimated 270,000 patients we're targeting to achieve our $1.5 billion plus net revenue goal for this important treatment. While we're pleased with our progress, it still only represents 3% of the 3.1 million people diagnosed with opioid use disorder.

您還會注意到，第一季末的 SUBLOCADE 患者數量約為 95,000 名。這只是我們為實現這一重要治療方法的 15 億美元加淨收入目標而預計覆蓋 270,000 名患者的目標的 1/3 多一點。雖然我們對我們的進展感到滿意，但它仍然只佔 310 萬人被診斷出患有阿片類藥物使用障礙的 3%。

Moving next to diversification and starting with PERSERIS, we continue to see unit growth in volume and the number of new HCPs prescribing across our territories. Net revenue of $8 million reflects growth of 60% versus Q1 2022, but was negatively impacted by wholesaler destocking when looking at the quarter sequential comparison.

接下來是多元化，從 PERSERIS 開始，我們繼續看到我們地區的單位數量和新 HCP 數量的增長。淨收入為 800 萬美元，較 2022 年第一季成長 60%，但與季度環比相比，受到批發商去庫存的負面影響。

Overall, we're pleased with the KPIs which remain strongly positive, including underlying dispense growth and sample demand across inpatient acute care psychiatric facilities and outpatient clinics. Taken together, we remain confident in our full year net revenue outlook for PERSERIS.

總體而言，我們對仍然非常積極的關鍵績效指標感到滿意，包括住院急診精神科和門診診所的基本配藥成長和樣本需求。總的來說，我們對 PERSERIS 的全年淨收入前景仍然充滿信心。

Turning the ex-U.S. net revenue, strong growth from new products, which include both SUBLOCADE and SUBOXONE Film, drove the 5% increase in overall Rest of World net revenue. SUBLOCADE continued to make solid progress while net revenue contribute -- with net revenue contribution of $9 million.

轉向前美國包括 SUBLOCADE 和 SUBOXONE Film 在內的新產品帶來的淨收入強勁增長推動了世界其他地區整體淨收入增長 5%。 SUBLOCADE 繼續取得紮實進展，同時貢獻了淨收入 - 淨收入貢獻為 900 萬美元。

We continue to see strength in our ex-U.S. markets, including the Nordics launch, where we launched the SUBLOCADE in late 2022. We look forward to launching SUBLOCADE in Germany in May and remain focused on returning our Rest of World business to sustainable growth with SUBLOCADE and SUBOXONE Film.

我們繼續看到美國以外地區的實力市場，包括北歐市場，我們於 2022 年底推出了 SUBLOCADE。我們期待 5 月在德國推出 SUBLOCADE，並繼續致力於透過 SUBLOCADE 和 SUBOXONE Film 讓我們在世界其他地區的業務恢復可持續增長。

Lastly, on diversification. As I mentioned before, we successfully closed and integrated the Opiant transaction. And in a moment, I'll provide a bit more detail on our plan for OPNT003.

最後，關於多元化。正如我之前提到的，我們成功完成並整合了 Opiant 交易。稍後，我將提供有關 OPNT003 計劃的更多細節。

Turning to our pipeline. We're pleased to have brought on board Opiant's asset portfolio and team, which gives us significant addiction medicine development experience and expertise across a broad array of delivery platforms, including depot, oral and now nasal delivery technologies.

轉向我們的管道。我們很高興引進 Opiant 的資產組合和團隊，這為我們提供了豐富的成癮藥物開發經驗和跨廣泛的遞送平台的專業知識，包括儲庫、口服和現在的鼻腔遞送技術。

Under Christian's leadership, the R&D teams have come together nicely and are moving at pace to advance our key programs. By combining our portfolios, Indivior now has more robust pipeline to address patients' most urgent needs across the continuum of care for substance use disorders.

在克里斯蒂安的領導下，研發團隊很好地團結在一起，並正在快速推進我們的關鍵項目。透過整合我們的產品組合，Indivior 現在擁有更強大的管道，可以在藥物濫用障礙的連續護理過程中滿足患者最緊迫的需求。

Our fourth strategic pillar is optimizing our operating model and capital allocation. Here, our financial position remains strong despite cash outflows associated with the Opiant acquisition and completion of our second share buyback program.

我們的第四個策略支柱是優化我們的營運模式和資本配置。儘管與 Opiant 收購和完成第二次股票回購計畫相關的現金流出，我們的財務狀況仍然強勁。

Finally, with regards to the additional U.S. listing of our shares, we look forward to completing the necessary regulatory requirements and expect to affect Nasdaq listing in June.

最後，關於我們股票在美國的額外上市，我們期待完成必要的監管要求，並預計影響 6 月的納斯達克上市。

Before concluding my remarks, let me provide a brief status update on Opiant. We closed the acquisition on March 2 and moved quickly to embrace Opiant's teams. It's now nearly 2 months into our combination and I'm very pleased with how we've come together as one company focused on patient needs.

在結束演講之前，讓我先簡單介紹一下 Opiant 的最新動態。我們於 3 月 2 日完成了收購，並迅速採取行動接納 Opiant 的團隊。現在我們的合併已經近兩個月了，我對我們作為一家專注於患者需求的公司走到一起感到非常滿意。

Clearly, our most immediate and compelling opportunity is OPNT003, which has a PDUFA action date of May 22. At this point, I have to make the standard cautionary comment that this is entirely subject to FDA approval. Nevertheless, assuming this proceeds as we anticipate, we are in full planning mode for a Q4 launch. As such, our updated fiscal year 2023 guidance does reflect incremental investment for launching OPNT003 later this year.

顯然，我們最直接和最引人注目的機會是 OPNT003，它的 PDUFA 行動日期為 5 月 22 日。此時，我必須做出標準的警告評論，這完全需要 FDA 的批准。儘管如此，假設一切如我們預期的那樣進行，我們正在全面規劃第四季度的發布。因此，我們更新的 2023 財年指導確實反映了今年稍後推出 OPNT003 的增量投資。

Given the recent interest, I'd like to just take a moment to address the recent OTC approvals for Naloxone. We certainly applaud efforts to increase access for all FDA-approved medications. To be clear, OPNT003 will not be an OTC product, if approved, and therefore, our primary launch efforts will be squarely focused on the public interest markets.

鑑於最近的興趣，我想花點時間談談納洛酮最近的非處方藥批准。我們當然讚揚為增加所有 FDA 批准的藥物的可及性所做的努力。需要明確的是，如果獲得批准，OPNT003將不會成為OTC產品，因此，我們的主要上市工作將直接集中在公共利益市場。

This includes law enforcement, first responders, departments of health, schools and corrections and so on. This approach reflects the unique profile of OPNT003, which was developed specifically to address the epidemic of overdose deaths arising from misuse of fentanyl and other synthetic opioids. Importantly, we believe we can cover all these key national public interest call points with a relatively small, focused and efficient field force.

這包括執法部門、急救人員、衛生部門、學校和懲教部門等。這種方法反映了 OPNT003 的獨特特徵，該藥物是專門為解決因濫用芬太尼和其他合成鴉片類藥物而引起的過量死亡流行病而開發的。重要的是，我們相信我們可以透過相對較小、專注且有效率的現場人員來滿足所有這些關鍵的國家公共利益需求。

Next, to preempt your questions on pricing, we're still in the process of finalizing our strategy, but we will certainly look to price responsibly while considering the innovative nature of the product. Lastly, while our fiscal year 2023 guidance does not assume material net revenue contribution from OPNT003, given the anticipated launch timing late in the year, we continue to be confident in 003's peak net revenue potential of $150 million to $250 million and continue to expect it to be accretive to earnings after the second full year of launch.

接下來，為了避免您提出有關定價的問題，我們仍在最終確定我們的策略的過程中，但我們肯定會在考慮產品的創新性的同時以負責任的方式定價。最後，雖然我們的2023 財年指引並未假設OPNT003 會帶來實質的淨收入貢獻，但考慮到預計將在今年稍後推出，我們仍然對003 的1.5 億至2.5 億美元峰值淨收入潛力充滿信心，並繼續預期這一點在推出第二個完整年度後增加收益。

To conclude my formal remarks, the team has delivered an excellent start to the year with strong top line growth on SUBLOCADE and PERSERIS and continued return to growth in our ex-U.S. markets. We're looking forward to the launch of OPNT003, subject to approval and have raised our fiscal year 2023 net revenue guidance.

最後，我的正式演講結束了，該團隊在今年取得了良好的開局，SUBLOCADE 和 PERSERIS 的營收強勁增長，並且在美國以外地區繼續恢復增長。市場。我們期待 OPNT003 的推出（尚待批准），並提高了 2023 財年淨收入指引。

And last but not least, we're working diligently to remove uncertainty for stakeholders as we seek to resolve legacy legal items so that we can exclusively focus on achieving our business goals.

最後但並非最不重要的一點是，在尋求解決遺留法律問題時，我們正在努力消除利害關係人的不確定性，以便我們能夠專注於實現我們的業務目標。

With that introduction, I'll turn it over to Ryan.

有了這個介紹，我就把它交給瑞安。

Thanks, Mark, and good morning and good afternoon to everyone. We had a very good start to full year 2023 and are pleased with our continued execution. During the quarter, overall double-digit top line growth was once again driven by the strong performance of SUBLOCADE.

謝謝，馬克，大家早安，下午好。我們在 2023 年全年有了一個良好的開端，並對我們的持續執行感到滿意。本季度，SUBLOCADE 的強勁表​​現再次推動整體營收實現兩位數成長。

Our reported and adjusted operating profit also increased versus the prior year, reflecting our increased net revenue from the investments in sales and marketing we have made over the last year to accelerate the growth of our long-acting injectables. We also maintained our financial flexibility with approximately $803 million in cash and investments at the end of the quarter.

我們的報告和調整後營業利潤也較上年有所增長，反映出我們去年為加速長效注射劑的增長而對銷售和營銷進行的投資帶來的淨收入增加。截至本季末，我們也保持了財務靈活性，擁有約 8.03 億美元的現金和投資。

Before discussing the financial results for Q1, I do want to spend a moment discussing the accounting of the Opiant transaction now that the deal has closed. The final purchase price was $146 million, plus approximately $12 million in exceptional deal and transaction costs. Substantially, all of the purchase price is reflected in intangibles on the balance sheet and we expect to amortize this through COGS over the current 15-year patent life expectation of 003.

在討論第一季的財務表現之前，我確實想花點時間討論 Opiant 交易的會計處理，因為交易已經結束。最終收購價格為 1.46 億美元，另加約 1,200 萬美元的特殊交易和交易成本。實質上，所有購買價格都反映在資產負債表上的無形資產中，我們預計將在 003 當前 15 年專利壽命預期中透過銷貨成本攤銷。

The amortization expense will be treated as exceptional and is noncash and nontaxable. The possible liability for the contingent value rights, CVRs will be assessed quarterly and will be amortized in the same manner.

攤銷費用將被視為特殊費用，且是非現金且免稅的。或有價值權利 CVR 的可能負債將按季度評估，並以相同方式攤提。

I will now provide some more detail on the drivers of our performance in the quarter and discuss our revised guidance. Starting with the top line. Total net revenue grew 22% versus the year ago quarter and by 24%, excluding the impact of FX. The increase was primarily due to SUBLOCADE, which grew 55% versus Q1 2022 to $132 million.

我現在將提供有關本季度業績驅動因素的更多詳細信息，並討論我們修訂後的指導。從頂線開始。淨收入總額較去年同期成長 22%，若剔除外匯影響，則成長 24%。這一增長主要歸功於 SUBLOCADE，該項目與 2022 年第一季相比增長了 55%，達到 1.32 億美元。

By geography, total U.S. net revenue grew by 27% and currently represents 83% of total company net revenue. Net revenue in the Rest of the World was up 5% year-over-year at actual FX rates and 13% if you exclude FX.

按地區劃分，美國總淨收入成長了 27%，目前占公司總淨收入的 83%。以實際匯率計算，世界其他地區的淨收入年增 5%，如果排除外匯，則成長 13%。

As Mark mentioned, growth of SUBLOCADE net revenue outside of the U.S. was strong, up 50% versus the year ago quarter to $9 million. Our progress with SUBLOCADE and SUBOXONE Film outside the U.S. continues to offset the decline in the legacy tablet business.

正如 Mark 所提到的，SUBLOCADE 在美國以外的淨收入成長強勁，比去年同期成長 50%，達到 900 萬美元。我們在美國境外的 SUBLOCADE 和 SUBOXONE Film 的進展繼續抵消了傳統平板電腦業務的下滑。

Total SUBLOCADE net revenue for the first quarter of $132 million was up 12% sequentially, reflecting stocking in Q4 that did not reoccur this quarter. Dispenses were up 16% sequentially, showing strong underlying growth. This performance is consistent with our full year guidance of $550 million to $600 million.

第一季 SUBLOCADE 總淨收入為 1.32 億美元，比上一季成長 12%，反映了第四季的庫存情況，而本季沒有再次出現這種情況。配藥量較上季成長 16%，顯示出強勁的潛在成長。這項業績與我們 5.5 億至 6 億美元的全年指引一致。

Moving to PERSERIS. Net revenue of $8 million was up 60% versus the first quarter of last year and was within our expectations. As Mark noted, there was some destocking dynamics in the quarter, which impacted the sequential comparison. Underlying prescription growth and other supporting KPIs continue to be strong and underpin our net revenue guidance for the year.

搬到佩爾塞里斯。淨收入為 800 萬美元，比去年第一季成長 60%，符合我們的預期。正如馬克指出的那樣，本季出現了一些去庫存動態，這影響了連續比較。基礎處方成長和其他支持性 KPI 繼續強勁，支撐著我們今年的淨收入指引。

Turning to SUBOXONE Film. Average share in the first quarter was approximately 19%, which is essentially flat sequentially. We continue to expect an accelerated rate of SUBOXONE Film market share decline in full year 2023, reflecting underlying erosion at a similar rate to the last 2 years, approximately 2 share points, together with the assumed impact from an approved fourth generic entering the U.S. market in the second half of 2023. As a reminder, we do not promote SUBOXONE Film in the U.S.

轉向 SUBOXONE 薄膜。第一季的平均份額約為 19%，與上一季基本持平。我們繼續預期SUBOXONE Film 的市佔率在2023 年全年將加速下降，反映出潛在的侵蝕速度與過去2 年類似，約2 個百分點，再加上核准的第四個仿製藥進入美國市場的假設影響2023 年下半年。提醒一下，我們不在美國推廣 SUBOXONE 薄膜。

Moving down to P&L. Our first quarter adjusted gross margin was 85%, up from 82% in the prior quarter and prior year. This was driven by favorable manufacturing variances such as FX and a higher mix of SUBLOCADE net revenue. We continue to expect gross margins to be in the low to mid-80%s range for the full year.

向下移動到損益表。我們第一季調整後毛利率為 85%，高於上一季及去年同期的 82%。這是由外匯等有利的製造差異和子定位淨收入的更高組合所推動的。我們仍然預計全年毛利率將在 80% 的低至中水平範圍內。

Adjusted SG&A expenses were $117 million in the quarter, up 7% versus Q1 last year, primarily reflecting the overall cost inflation and commercial investments to accelerate SUBLOCADE access in the U.S. justice system.

本季調整後的 SG&A 費用為 1.17 億美元，比去年第一季成長 7%，主要反映了整體成本通膨和加速美國司法系統使用 SUBLOCADE 的商業投資。

R&D expenses were $27 million in the quarter, reflecting phasing of SUBLOCADE studies, manufacturing capacity expansion and other pipeline activities. In a moment, I will discuss our revised view of expenses for the year considering the addition of the Opiant business.

本季研發費用為 2,700 萬美元，反映分階段的 SUBLOCADE 研究、製造產能擴張和其他管道活動。稍後，我將討論考慮到 Opiant 業務的增加，我們對本年度費用的修訂看法。

Our adjusted operating profit of $71 million in Q1 was up 31% versus the prior year, primarily based on higher net revenue, partially offset by the higher operating expenses I discussed before.

我們第一季調整後的營業利潤為 7,100 萬美元，比上一年增長了 31%，這主要是由於淨收入的增加，部分被我之前討論過的較高的營業費用所抵消。

Turning to our balance sheet and capital position. We maintained our solid liquidity position and ended the quarter with gross cash and investments of $803 million, down from $991 million at year-end. The reduction in cash and investments primarily reflects the net purchase price of $124 million for Opiant Pharmaceuticals, including the transferred cash balance and $74 million primarily in annual scheduled payments for the DOJ, RB and DRL settlements. Cash generated from operations, excluding these settlement items was $58 million.

轉向我們的資產負債表和資本狀況。我們保持了穩健的流動性狀況，本季末現金和投資總額為 8.03 億美元，低於年底的 9.91 億美元。現金和投資的減少主要反映了 Opiant Pharmaceuticals 1.24 億美元的淨收購價，包括轉移的現金餘額和主要用於 DOJ、RB 和 DRL 和解的年度計劃付款的 7,400 萬美元。除去這些結算項目，營運產生的現金為 5,800 萬美元。

Turning to guidance for full year 2023. As we noted in our release, we have updated our full year 2023 guidance to reflect the increased expenses resulting from the acquisition of Opiant as well as increased net revenue expectations primarily due to the continued delay of the expected U.S. launch of the fourth film generic. We now assume the latter will occur at some point from mid-2023 onwards. But as we have said previously, we do not have any visibility or market intelligence on timing.

轉向 2023 年全年指引。正如我們在新聞稿中指出的那樣，我們更新了 2023 年全年指引，以反映收購 Opiant 導致的費用增加以及淨收入預期的增加，這主要是由於預期的持續延遲美國推出第四種仿製藥。我們現在假設後者將在 2023 年中期以後的某個時間發生。但正如我們之前所說，我們沒有任何關於時機的可見性或市場情報。

Guidance was SUBLOCADE and PERSERIS net revenue is unchanged as is the case for gross margin and our underlying OpEx expectations prior to adding Opiant. Our revised guidance for OpEx assumes regulatory approval of 003 by the FDA on or before the PDUFA date of May 22 and a launch in the fourth quarter of this year. Given the expected late 2023 launch date for 003, we assume the impact to net revenue will not be material for full year 2023.

指引是 SUBLOCADE 和 PERSERIS 淨收入不變，毛利率和我們在添加 Opiant 之前的基本營運支出預期也是如此。我們修訂後的 OpEx 指南假設 003 在 5 月 22 日 PDUFA 日期或之前獲得 FDA 監管批准，並於今年第四季推出。鑑於《003》預計將於 2023 年稍後推出，我們假設這對 2023 年全年淨收入的影響不會重大。

Taking these elements together, we are raising our overall net revenue range to $970 million to $1.040 billion from $950 million to $1.020 billion. The new point of our guidance now suggests net revenue growth of 12% versus last year.

綜合考慮這些因素，我們將整體淨收入範圍從 9.5 億美元至 10.2 億美元提高到 9.7 億美元至 10.4 億美元。我們的新指導點現在顯示淨收入比去年增長 12%。

Moving to our revised OpEx guidance. We now expect SG&A to be in the range of $530 million to $540 million -- excuse me, from $490 million to $500 million. The increase primarily reflects the addition of Opiant's commercial teams, including sales, access and medical affairs person well as well as the planned launch and marketing expenses for 003 in Q4 2023.

轉向我們修訂後的營運支出指南。我們現在預計 SG&A 範圍為 5.3 億美元至 5.4 億美元——對不起，是 4.9 億美元至 5 億美元。這一成長主要反映了 Opiant 商業團隊的增加，包括銷售、准入和醫療事務人員以及計劃在 2023 年第四季度推出 003 的上市和行銷費用。

For R&D, we now expect a range of $90 million to $100 million from $80 million to $90 million, reflecting the addition of Opiant's R&D personnel and assumption of their pipeline activities.

對於研發，我們現在預計範圍為 9,000 萬美元至 1 億美元，從 8,000 萬美元到 9,000 萬美元，反映了 Opiant 研發人員的增加以及對其管道活動的承擔。

Lastly, on adjusted operating profit, we now expect this to be slightly below full year 2022 adjusted operating profit of $212 million as a result of the additional operating expenses associated with the Opiant acquisition, partially offset by the increased net revenue expectations.

最後，關於調整後的營業利潤，我們現在預計，由於與Opiant 收購相關的額外營業費用，該數字將略低於2022 年全年2.12 億美元的調整後營業利潤，但部分被增加的淨收入預期所抵消。

In closing, we are pleased with our execution and our financial results for the quarter. We believe our Q1 performance puts us solidly on track to deliver our revised full year 2023 guidance and look forward to updating the market as the year progresses.

最後，我們對本季的執行情況和財務表現感到滿意。我們相信，第一季的業績使我們堅定地走上交付修訂後的 2023 年全年指引的軌道，並期待隨著這一年的進展更新市場情況。

I will now turn the call back over to Mark.

我現在將把電話轉回給馬克。

Thank you, Ryan. So in summary, a strong start to fiscal year 2023 by the entire Indivior team delivering against our strategic priorities, continued momentum behind SUBLOCADE, a raise in net revenue guidance based on the film resilience and integration of Opiant and preparation for launch of 003, if approved, as well as planning for the U.S. listing on the Nasdaq in June.

謝謝你，瑞安。總而言之，整個 Indivior 團隊在 2023 財年取得了良好的開端，實現了我們的戰略重點，SUBLOCADE 背後的持續動力，基於電影彈性和 Opiant 整合的淨收入指引的提高以及 003 推出的準備，如果併計劃於六月在美國納斯達克上市。

With that, I'll open up to the questions-and-answer period.

接下來，我將進入問答環節。

And your first question comes from the line of Paul Cuddon from Numis.

你的第一個問題來自 Numis 的 Paul Cuddon。

I have 2 questions, please. Firstly, on the incremental quarter-on-quarter growth for SUBLOCADE into Q1 at sort of plus 12%, I just wonder if there's anything that you sort of want to flag for Q2? I mean could it be double-digit again in Q2? Or should we anticipate that Q1 had a bit of stocking?

我有 2 個問題，請問。首先，第一季 SUBLOCADE 的環比增量增加了 12%，我只是想知道您是否想為第二季標記一些東西？我的意思是第二季能否再次達到兩位數？或者我們應該預期第一季會有一些庫存？

And then secondly, just on the gross margin, 84.5% was a bit better than we were expecting. I'm just wondering, is that sort of possible that that could continue kind of as the year kind of progresses?

其次，就毛利率而言，84.5% 比我們的預期要好一些。我只是想知道，隨著時間的推移，這種情況是否有可能繼續下去？

Thanks for the question, Paul. I'll handle the first one, and then I'll ask Ryan to comment with regards to the gross margin profile in Q1.

謝謝你的提問，保羅。我將處理第一個問題，然後我將請 Ryan 對第一季的毛利率狀況發表評論。

Listen, we are extremely pleased with the progress in the delivery in the first quarter really demonstrates that our organization health system strategy and our go-to-market structure that we pivoted to in fall of 2020 is working and working well. With over 90,000 patients using SUBLOCADE over the last 12 months, it just gives us continued confidence behind our peak net revenue goal of greater than $1.5 billion. It also with the way we started the first quarter gives us strong confidence in the range that we've given for the year and achieving that.

聽著，我們對第一季的交付進展感到非常滿意，這確實表明我們的組織衛生系統策略和我們在 2020 年秋季轉向的市場進入結構正在發揮作用，而且運作良好。過去 12 個月內有超過 90,000 名患者使用 SUBLOCADE，這讓我們對超過 15 億美元的淨收入目標高峰充滿信心。我們第一季開始的方式也讓我們對今年的目標範圍和實現這一目標充滿信心。

We don't break down kind of the quarter-to-quarter sort of guidance on that, Paul. So I'll have to ask for a little bit of relief on that question. But again, we do have a lot of conviction behind the full year numbers.

保羅，我們不會分解季度到季度的指導。所以我必須請求大家對這個問題有所緩解。但同樣，我們對全年數據確實充滿信心。

And then on the gross margin question, yes, there's no doubt that we did have a good gross margin percentage quarter and we look forward to the margins continue to expand as SUBLOCADE becomes the larger contributor to our profile. But I would caution that there was some FX benefit and some favorable production variances such as lower write-offs versus prior year in the quarter and those may or may not repeat in the balance to go, hence, the reason why we are still confident in our guidance range of low to mid-80%s for the year.

然後關於毛利率問題，是的，毫無疑問，我們確實有一個良好的毛利率季度，我們期待利潤率繼續擴大，因為 SUBLOCADE 成為我們形象的更大貢獻者。但我要提醒的是，存在一些外匯收益和一些有利的生產差異，例如本季度與上一年相比沖銷較低，這些可能會也可能不會在餘額中重複，因此，我們仍然對我們今年的指導範圍為80% 左右。

And your next question comes from the line of Thibault Boutherin from Morgan Stanley.

你的下一個問題來自摩根士丹利的蒂博·布瑟林（Thibault Boutherin）。

Three, please. The first one on litigation. The press release mentioned that new offers and demands have been exchanged with the state in the context of the MDL litigation. So just curious to know why the states have been singled out here? What about the other classes of plants, so the direct purchasers and payers, which are also involved in the MDL? Is there any reason why they have been excluded from these additional exchanges? So that's the first question.

請三人。第一個是訴訟。新聞稿提到，在 MDL 訴訟的背景下，已與州政府交換了新的提案和要求。所以只是想知道為什麼這些州在這裡被單獨挑出來？其他類別的工廠（即也參與 MDL 的直接購買者和付款人）又如何呢？他們被排除在這些額外的交易所之外有什麼原因嗎？這是第一個問題。

Second one, on the ex-U.S. sales for films and tablets. It looks like the numbers have been stabilizing for a few quarters now. Could we start to see some growth here? Could you just give some color on the drivers behind the potential growth and how much we could expect?

第二個，關於美國以外的地區電影和平板電腦的銷售。看起來這些數字已經穩定了好幾個季度。我們可以開始看到一些成長嗎？您能否介紹一下潛在成長背後的驅動因素以及我們的預期？

And then last question on your plans for the launch of OPNT003, Hikma tried to launch a high dose version of Naloxone, 8 milligrams, branded product called KLOXXADO. I think that strategy was similar to the one you -- I think you are thinking about for your own product. It seems that the uptake so far for them has been relatively modest and clearly, very far away from the ambitions you have for OPNT003. So if you could just give us some details on the differentiation that you have either in terms of go-to-market model or in terms of product differentiation that could be key to drive an update in this market?

關於您推出 OPNT003 的計劃的最後一個問題，Hikma 試圖推出高劑量版本的納洛酮，8 毫克，品牌產品稱為 KLOXXADO。我認為這一策略與您正在為自己的產品考慮的策略類似。到目前為止，他們的接受程度似乎相對較低，而且顯然與您對 OPNT003 的抱負相去甚遠。那麼，您能否向我們提供一些有關您在上市模式或產品差異化方面的差異化細節，這可能是推動該市場更新的關鍵？

Thibault, thanks for the question. I think look, I'll start with the litigation and a little bit of commentary on 003 and then I'll hand to Ryan to talk about the trends that we're seeing in the film and tablet market between both the U.S. and Rest of World.

蒂博，謝謝你的提問。我想，我將從訴訟和對 003 的一些評論開始，然後我將請 Ryan 談談我們在美國和其他國家之間的電影和平板電腦市場中看到的趨勢。

On the litigation side, I think the key message here is that mediation with stakeholders continues to proceed with engagement from the court and we continue to aspire to bring certainty for all stakeholders at the appropriate value. If you look at the provision for the quarter, which we reassess every quarter across management with the Board and with the auditors, the provision with our best estimate has not changed. So we'll continue to progress moving forward. We expect further mediation sessions moving ahead. And that's about all I can say on this matter due to the ongoing nature of this matter before the court. So on the litigation, that's where we are.

在訴訟方面，我認為這裡的關鍵訊息是，與利害關係人的調解繼續在法院的參與下進行，我們繼續渴望以適當的價值為所有利益相關者帶來確定性。如果你看一下本季的撥備，我們每季都會與董事會和審計師一起重新評估管理階層的撥備，就會發現我們最佳估計的撥備並沒有改變。因此，我們將繼續前進。我們預計將會有更多的調解會議繼續進行。鑑於此案正在法庭上審理，我對此只能說這麼多。所以在訴訟方面，這就是我們的處境。

With regards to 003 and the Naloxone market, I think what we're trying to do here with the launch of 003 is the team has created what we believe to be a transformational product in this space, utilizing a totally different active in the space with a very, very different product profile. Nalmefene, if you look at nalmefene versus Naloxone, it has a higher affinity to the receptors, it tends to act quicker to get to peak values and its half-life is much longer, more in line and just beyond the typical sort of synthetic opioids that you're seeing.

關於 003 和納洛酮市場，我認為我們在推出 003 時試圖做的是，團隊創造了我們認為是該領域的變革性產品，利用了該領域完全不同的活性物質非常非常不同的產品概況。納美芬，如果你比較納美芬和納洛酮，你會發現它對受體的親和力更高，往往更快地達到峰值，而且它的半衰期更長、更一致，甚至超出了典型的合成阿片類藥物你所看到的。

So the product is completely different, and we believe it will be the next paradigm of treatment for these synthetic opioids, which as you follow the market and you look at the over 200 deaths a day that are occurring, 90% of those are coming from fentanyl. So we think this is the product moving forward that if my daughter was out there, I'd want her to have it in her pocket book. So with that as kind of the 003, I'll hand over to Ryan to talk through the films and tablets.

因此，該產品是完全不同的，我們相信它將成為這些合成鴉片類藥物的下一個治療範例，當您追蹤市場並查看每天發生的 200 多人死亡時，您會發現其中 90% 來自芬太尼。所以我們認為這是一個正在發展的產品，如果我的女兒在那裡，我希望她能把它放在她的口袋裡。因此，就像 003 一樣，我將交給 Ryan 討論電影和平板電腦。

Thanks, Mark. So in regards to the film business here in the U.S., we are still certainly surprised that the fourth generic hasn't launched at this point. We will certainly take the cash that's being generated from the film's resilience. But we do caution that we do plan, as we said in our guidance, that our assumption is that they will launch now at some time in the second half, and we are planning for further share erosion at that point. There's no fundamental reason why they shouldn't launch. And our objective is to keep a pulse on the marketplace and update you accordingly.

謝謝，馬克。因此，就美國的電影業務而言，我們仍然對第四種仿製藥目前尚未推出感到驚訝。我們肯定會從這部電影的韌性中獲得現金。但我們確實警告說，正如我們在指導中所說，我們確實有計劃，我們的假設是它們將在下半年的某個時候推出，並且我們正計劃在那時進一步侵蝕份額。沒有根本原因說明他們不應該啟動。我們的目標是隨時掌握市場脈動並為您提供相應的最新資訊。

In regards to the Rest of the World, really proud of the work that the Rest of the World team is doing, where they're stemming the losses that we've seen over the last couple of years where we've introduced film and SUBLOCADE into certain markets and you're starting to see, as we mentioned today, almost 12% or 13% year-over-year growth primarily tied to film and SUBLOCADE.

關於世界其他地區，我們對世界其他地區團隊正在做的工作感到非常自豪，他們正在阻止我們在過去幾年中看到的損失，我們引入了膠片和子定位正如我們今天提到的，您開始看到某些市場的年增近12% 或13%，主要與電影和SUBLOCADE 相關。

So I think you're seeing some stronger tab business resilience, especially in large markets such as France. And then you're also seeing some of the nice performance on the new launches on film. And so when you combine all those, that's why we feel comfortable bringing up our total net revenue on the top line due to film and tablet.

因此，我認為您會看到一些更強勁的標籤業務彈性，特別是在法國等大型市場。然後您還會看到新推出的電影中的一些精彩表演。因此，當你將所有這些結合起來時，這就是為什麼我們放心地將電影和平板電腦的總淨收入提高到頂線。

(Operator Instructions) And your next question comes from the line of Max Herrmann from Stifel.

（操作員說明）您的下一個問題來自 Stifel 的 Max Herrmann。

Congratulations on a strong start to the year. 3 questions, if I may. Firstly, on SUBLOCADE and moving on to the OPNT003 launch. And then finally, just in terms of the -- again, a follow-up on SUBLOCADE. In terms of the SUBLOCADE sales, how are you seeing the mix between doctors who are currently prescribing it and maybe then increasing the share of patients that they are prescribing it to and actually adding new doctors to the roster? So that's kind of first question. So just trying to understand where the real driver is new doctor adds? Or is it just broadening or how is the balance between the 2?

祝賀今年取得了良好的開局。如果可以的話，我問 3 個問題。首先是 SUBLOCADE，然後是 OPNT003 的發布。最後，再次強調 SUBLOCADE 的後續行動。就 SUBLOCADE 銷售而言，您如何看待目前正在開立這種藥的醫生之間的混合情況，然後可能會增加他們開這種藥的患者比例，並實際上在名冊中添加新醫生？這是第一個問題。那麼，只是想了解真正的驅動因素在哪裡，新醫生補充道？或者只是擴大或兩者之間的平衡如何？

Yes, it's a great question, Max. And really, I think the whole focus on SUBLOCADE, now that we've been on this journey for organized health systems for a couple of years, it's focused on depth. These large organized health systems have multiple sort of subsidiaries out there and we're at the very early stages of driving depth of activation of those subsidiary accounts of driving more depth with current active providers as well as bringing, as you said ever so eloquently, new HCPs to the roster.

是的，這是一個很好的問題，麥克斯。事實上，我認為整個重點放在子定位上，既然我們已經踏上有組織的衛生系統的旅程幾年了，它的重點是深度。這些大型有組織的衛生系統擁有多種類型的子公司，我們正處於推動這些子公司帳戶激活深度的早期階段，與當前活躍的提供者進行更深入的合作，以及帶來，正如您曾經雄辯地說的那樣，新的 HCP 加入名冊。

And so the growth you're seeing is coming across all of those vectors, which gives us the confidence in the continued journey, both the confidence of our guidance for this year, but the confidence of being greater than $1.5 billion for peak net revenue guidance. So it's pretty good growth across all the vectors.

因此，您所看到的成長是在所有這些方面實現的，這讓我們對繼續前進充滿信心，既對今年的指導充滿信心，又對峰值淨收入指導超過 15 億美元充滿信心。所以所有向量的成長都非常好。

Are there sort of lessons you can learn from sort of certain doctors and how they're prescribing to their patients that you can then kind of replicate in other maybe sales regions that you can use best practice from one region to another? And I'm just trying to understand the lessons that you may be learning there between the different areas. Just to try and see what the lead areas may be achieving.

您是否可以從某些醫生身上學到一些經驗教訓，以及他們如何向患者開處方，然後您可以在其他可能的銷售區域複製這些經驗教訓，從而可以在一個區域到另一個區域使用最佳實踐？我只是想了解您在不同領域之間可能學到的教訓。只是為了嘗試看看領先領域可能會取得什麼成果。

Yes. Absolutely, Max. I think in any point in time where you're in the launch and trying to change the true paradigm of treatment. We're still in the early days with about a 3% share of the market and we see huge potential for the asset. So every -- continuously through the year, the team is taking learnings. They're having calls across the different areas, sharing best practices. We are continuing to modify the detailed aids to talk about this paradigm shift based on those learnings, both from where we have significant depth in prescribing, but where we see earlier prescribing and taking all of those lessons and building into our approach as we continue to drive penetration in the market, so.

是的。絕對，馬克斯。我認為在任何時候，當你處於啟動階段並試圖改變真正的治療模式時。我們仍處於早期階段，約佔 3% 的市場份額，我們看到了該資產的巨大潛力。因此，每年，團隊都在不斷學習。他們在不同領域進行通話，分享最佳實踐。我們正在繼續修改詳細的輔助工具，以根據這些經驗來討論這種範式轉變，無論是從我們在處方方面有很大深度的地方，還是從我們看到的早期處方和吸收所有這些經驗教訓，並隨著我們繼續學習而融入我們的方法中。推動市場滲透，因此。

And so the second question on SUBLOCADE is about the sort of relaxation of legislation, which will, I believe, allow you to use or dispense from a different location to the prescribing location and that will potentially enable you to have injection clinics or clinics that allow patients to be administered away from the prescribing position. Has that legislation now been implemented? And where is it in terms of you being able to actually leverage that? I think that was one of the key issues that you had with the initial launch and the prescription journey.

因此，關於 SUBLOCADE 的第二個問題是關於立法的放鬆，我相信，這將允許您從與處方地點不同的地點使用或分配，並且這將有可能使您能夠擁有註射診所或允許注射的診所。患者在遠離處方位置的地方進行給藥。該立法現在已經實施了嗎？就你能夠實際利用這一點而言，它在哪裡？我認為這是您在最初推出和處方過程中遇到的關鍵問題之一。

No. It's absolutely front of mind. And recall that the law changed in December, and it basically removes Data 2000, which has this requirement that's unique to the prescribing of buprenorphine that had it so that the prescribing physician had to actually administer the injectables. And I think it was a law that was put in place back when injectables weren't contemplated. So it was to deal more with the orals and trying to prevent potential diversion associated with those.

不，這絕對是首要考慮的事情。回想一下，法律在 12 月發生了變化，它基本上刪除了 Data 2000，其中有一項對於丁丙諾啡處方來說是獨特的要求，因此處方醫生必須實際注射注射​​劑。我認為這是在沒有考慮注射劑時制定的法律。因此，我們需要更多地處理口頭問題，並努力防止與這些相關的潛在轉移。

But with the long-actings, the removal of the law we believe further normalizes the disease space similar to schizophrenia where patients can get a prescription from a psychiatrist who may not want to do the injection and they can go to an alternate site to have the injection done, we can now effectuate that for the treatment of opioid use disorder with SUBLOCADE.

但隨著長效藥物的出現，我們認為該法律的取消進一步使疾病空間正常化，類似於精神分裂症，患者可以從可能不想注射的精神科醫生那裡獲得處方，並且可以去另一個地點進行注射注射完成後，我們現在可以使用SUBLOCADE 來治療鴉片類藥物使用障礙。

Now with that change in law comes a build-out of infrastructure and the ability to get there. So it's not something that's going to happen overnight. It will take time, but we see it as certainly as a tailwind for future growth and normalization of the disease space, Max.

現在，隨著法律的改變，基礎設施和實現這一目標的能力也隨之增強。所以這不是一朝一夕就能發生的事。這需要時間，但我們認為這肯定是疾病空間未來成長和正常化的推動力，Max。

And then maybe just on the OPNT003 launch, how do you obviously approval potentially in May? What are the steps that you need to do to start to really get traction with these first responders? Is it going to be quite a long sales cycle? Does it take like you found with the criminal justice system, it can take quite a long time to negotiate those contracts? Can you start that process immediately on approval before the launch?

然後也許就在 OPNT003 發佈時，您顯然如何在 5 月批准潛在的批准？您需要採取哪些步驟才能開始真正吸引這些急救人員？銷售週期會不會很久？是否像您在刑事司法系統中發現的那樣，談判這些合約可能需要相當長的時間？您能否在發布前獲得批准後立即啟動該流程？

Yes. I think you're bringing some clarity to the process, which is quite different than on the treatment side where, first, you have to get access and then you can pull through by calling on physicians and talking about the merits of the asset.

是的。我認為你使這個過程變得更加清晰，這與治療方面有很大不同，在治療方面，首先你必須獲得訪問權，然後你可以透過拜訪醫生並談論資產的優點來完成任務。

On this side, you tend to be dealing more with buyers with contracting and talking them through and talking to the various first responders through the benefits of the potential benefits of this asset. And of course, we'll have -- if it's approved, we'll have a final label and be able to articulate those more fully.

在這方面，您傾向於更多地與買家打交道，簽訂合同，與他們進行交談，並透過該資產的潛在好處與各個急救人員進行交談。當然，如果獲得批准，我們將有一個最終標籤，並且能夠更全面地闡明這些標籤。

And so that cycle is based on their contracting cycles and their buyer cycles and those can be a little bit more even through time. And so this is -- this will be a build through time. We haven't given year-to-year guidance. We have said this year, we think it will be relatively de minimis amount of revenue. But we still do have confidence in the peak revenue of $150 million to $250 million based on what we're hearing out there.

因此，這個週期是基於他們的合約週期和買家週期，隨著時間的推移，這些週期可能會更加均勻。這就是——這將是一個隨著時間的推移而構建的。我們還沒有給出逐年指導。我們已經說過，今年我們認為這將是相對微不足道的收入。但根據我們所聽到的消息，我們仍然對 1.5 億至 2.5 億美元的峰值收入充滿信心。

We will now go to our next question. And your next question comes from the line of [Rohini Kompella] from Bank of America.

現在我們將討論下一個問題。您的下一個問題來自美國銀行的 [Rohini Kompella]。

I'm sorry if it has been already touched upon, but I just wanted to ask a little bit about the listing of the company on Nasdaq. Is there any long-term view in terms of the listing in U.K.? Is there a plan to move primarily listing to U.S. at some point? Or is it just going to be an additional listing?

如果已經提到了，我很抱歉，但我只是想詢問一下有關該公司在納斯達克上市的情況。對於在英國上市有什麼長遠的看法嗎？是否有計劃在某個時候主要轉移到美國上市？或者它只是一個附加列表？

Thanks for the question, Rohini. And listen, this is an additional listing. We'll still have our primary listing in the U.K. And just to remind the broader audience that the sole purpose of this is to bring additional exposure to both the company as well as the disease space in its largest opportunity market of the United States. So this is about that visibility for the company. And we're excited to be able to go live with that at some point in June. So thanks for the question.

謝謝你的提問，羅希尼。聽著，這是一個附加清單。我們仍將在英國進行主要上市，只是為了提醒更廣泛的受眾，這樣做的唯一目的是為公司以及美國最大的機會市場的疾病領域帶來更多曝光。所以這關係到公司的知名度。我們很高興能夠在六月的某個時候投入使用。謝謝你的提問。

There are currently no further questions. I will hand the call back to Mark.

目前沒有其他問題。我會將電話轉回給馬克。

Thank you, Sharon. And with that, I'd like to thank everyone for their continued support of Indivior. We look forward to continued engagement throughout the year at conferences and at the next set of earnings results. Thank you very much.

謝謝你，莎倫。在此，我要感謝大家對 Indivior 的持續支持。我們期待全年繼續參與會議和下一組獲利結果。非常感謝。

This concludes today's conference call. Thank you for participating. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。