Viatris Inc (VTRS) 2024 Q3 法說會逐字稿

Good morning, everyone, and welcome to the Viatris' Q3 2024 earnings call. (Operator Instructions)

大家早安，歡迎參加 Viatris 的 2024 年第三季財報電話會議。（操作員說明）

Please also note today's event is being recorded. At this time, I'd like to turn the floor over to Bill Szablewski, Head of Capital Markets. Please go ahead.

另請注意今天的活動正在錄製中。現在，我想請資本市場主管 Bill Szablewski 發言。請繼續。

Good morning, everyone. Welcome to our Q3 2024 earnings call. With us today is our CEO, Scott Smith; CFO, Doretta Mistras, Chief R&D Officer, Philippe Martin; and Chief Commercial Officer, Corinne Le Goff. During today's call, we will be making forward-looking statements on a number of matters, including our financial guidance for 2024 and various strategic initiatives. These statements are subject to risks and uncertainties.

大家早安。歡迎參加我們的 2024 年第三季財報電話會議。今天與我們在一起的是我們的執行長 Scott Smith；財務長 Doretta Mistras，首席研發長 Philippe Martin；首席商務官 Corinne Le Goff。在今天的電話會議中，我們將就許多事項做出前瞻性聲明，包括 2024 年的財務指導和各種策略舉措。這些陳述存在風險和不確定性。

We will also be referring to certain actual and projected non-GAAP financial measures. Please refer to today's slide presentation and our SEC filings for more information, including reconciliations of those non-GAAP measures to the most directly comparable GAAP measures.

我們也將提及某些實際和預期的非公認會計準則財務指標。請參閱今天的幻燈片演示和我們向 SEC 提交的文件以了解更多信息，包括這些非 GAAP 衡量標準與最直接可比的 GAAP 衡量標準的調整。

When discussing 2024 actual or reported results, we will be making certain comparisons to 2023 actual reported results on a divestiture adjusted operational basis, which excludes the impact of foreign currency rates and also excludes the proportionate results from the divestitures that closed in 2024 and 2023 from the 2023 period.

在討論2024 年實際或報告結果時，我們將在剝離調整後的營運基礎上與2023 年實際報告結果進行某些比較，其中不包括外幣匯率的影響，也不包括2024 年和2023 年完成的剝離的相應結果。

When discussing our expectations for 2024, we'll be making certain comparisons to 2024 actual or reported results on a divestiture adjusted operational basis, which excludes the impact of foreign currency rates, we may refer to those as changes on an operational basis.

在討論我們對2024 年的預期時，我們將在剝離調整後的營運基礎上與2024 年實際或報告結果進行某些比較，其中排除了外幣匯率的影響，我們可能將其稱為營運基礎上的變化。

With that, I'll hand the call over to our CEO, Scott Smith.

接下來，我會將電話轉交給我們的執行長 Scott Smith。

Good morning, everyone, and welcome to our third quarter earnings call. I'm very pleased to report that we had an outstanding quarter, continuing the strong momentum we've seen all year. We have achieved our sixth consecutive quarter of operational revenue growth and have delivered growth across adjusted EBITDA and adjusted earnings per share.

大家早安，歡迎參加我們的第三季財報電話會議。我很高興地向大家報告，我們度過了一個出色的季度，延續了全年的強勁勢頭。我們實現了連續第六個季度的營業收入成長，並實現了調整後 EBITDA 和調整後每股盈餘的成長。

In addition, we made significant strides in all three of our strategic pillars we laid out earlier this year: our diversified and growing base business, our financial strength and significant cash flow and our expanding innovative portfolio. Viatris is not only stronger and more streamlined but more importantly, our future direction is now clear and more focused.

此外，我們在今年稍早制定的所有三個策略支柱方面都取得了重大進展：我們的多元化和不斷增長的基礎業務、我們的財務實力和大量現金流以及我們不斷擴大的創新產品組合。Viatris 不僅變得更強大、更加精簡，更重要的是，我們未來的方向現在更加清晰、更加專注。

We are in a period of consistent base business growth, and we expect this momentum to continue into next year. I'm happy to report that in the third quarter, we delivered total revenues of $3.8 billion which represents operational revenue growth of approximately 3%, adjusted EBITDA of $1.3 billion, growing approximately 4% from a year ago and adjusted EPS of $0.75 per share, growing approximately 6%.

我們正處於基礎業務持續成長的時期，我們預計這種勢頭將持續到明年。我很高興地向大家報告，第三季我們的總營收為38 億美元，營運營收成長約3%，調整後EBITDA 為13 億美元，較去年同期成長約4%，調整後每股盈餘為0.75美元，成長約6%。

We had a very strong quarter of free cash flow generating $866 million, excluding the impact of transaction costs and taxes. New product revenues were also strong at $133 million in the quarter. We delivered on our commitment to use the proceeds from our divestitures to pay down debt, repaying approximately $1.9 billion in debt and putting us firmly on track to achieve our long-term gross leverage target.

我們季度的自由現金流非常強勁，產生 8.66 億美元，不包括交易成本和稅收的影響。本季新產品營收也很強勁，達到 1.33 億美元。我們兌現了使用資產剝離所得收益來償還債務的承諾，償還了約 19 億美元的債務，使我們堅定地走上了實現長期總槓桿目標的軌道。

With this milestone, the company is operating from a position of strength and has a clear and focused outlook that centers on capital allocation. We believe that how we prioritize capital allocation going forward will be the single most critical factor in optimizing and maximizing shareholder value and in driving future growth.

憑藉這一里程碑，該公司的營運實力雄厚，並擁有以資本配置為中心的清晰而專注的前景。我們相信，如何優先考慮未來的資本配置將是優化和最大化股東價值以及推動未來成長的最關鍵因素。

Returning value to shareholders through dividends and share repurchases will remain a central element of our plan. In 2025, we expect to be more aggressive on share buybacks given our current valuation level. This will be balanced with making disciplined investments in commercialized or late-stage assets through regional and global business development that leverage our unique commercial and R&D infrastructure to drive our future growth.

透過股利和股票回購向股東回報價值仍將是我們計畫的核心要素。鑑於我們目前的估值水平，我們預計 2025 年將更積極地進行股票回購。這將與透過區域和全球業務發展對商業化或後期資產進行嚴格投資相平衡，利用我們獨特的商業和研發基礎設施來推動我們未來的成長。

We expanded our innovative portfolio of patent-protected assets by entering into an exclusive licensing agreement with Lexicon Pharmaceuticals for sotagliflozin in all markets outside of the US and Europe.

透過與 Lexicon Pharmaceuticals 簽訂 sotagliflozin 在美國和歐洲以外所有市場的獨家授權協議，我們擴大了受專利保護的創新資產組合。

With this licensing agreement, we are continuing to build on our strong presence in cardiovascular disease, which already includes approximately $2.5 billion in annual revenue as well as selatogrel, which we licensed earlier this year. This agreement leverages our global health care gateway, which provides partners with access to our unique global infrastructure. We believe we will be able to leverage our experience in cardiovascular disease and our infrastructure to execute on the potential of sota.

透過這項許可協議，我們將繼續鞏固我們在心血管疾病領域的強大影響力，該領域已經包括約 25 億美元的年收入以及我們今年早些時候獲得許可的 selatogrel。該協議利用了我們的全球醫療保健網關，為合作夥伴提供了訪問我們獨特的全球基礎設施的機會。我們相信，我們將能夠利用我們在心血管疾病方面的經驗和基礎設施來發揮 Sota 的潛力。

This quarter is a great demonstration of the power of a stronger, more streamlined Viatris. We are seeing good performance from our base business, as demonstrated by our strong track record of delivering new product revenues and by our operational revenue growth over the past few quarters. We expect this momentum to continue into 2025.

本季充分展現了更強大、更精簡的 Viatris 的力量。我們看到我們的基礎業務表現良好，我們在交付新產品收入方面的良好記錄以及過去幾季的營運收入成長就證明了這一點。我們預計這種勢頭將持續到 2025 年。

Now I'd like to turn the call over to Philippe to share an update on our pipeline. Philippe?

現在我想將電話轉給 Philippe，分享我們管道的最新情況。菲利普？

Thanks, Scott. Our strong track record in delivering on our new product revenue is driven by the reliability of our base business pipeline. This diverse growth engine generates a steady flow of core generics, complex generics and novel products. Our focused execution on this robust pipeline gives us confidence in our ability to continue to grow our base business and address unmet medical needs.

謝謝，斯科特。我們在實現新產品收入方面的良好記錄是由我們基礎業務管道的可靠性所推動的。這種多元化的成長引擎產生了穩定的核心仿製藥、複雜仿製藥和新穎產品。我們對這一強大管道的專注執行使我們對繼續發展基礎業務和解決未滿足的醫療需求的能力充滿信心。

Effexor is a great example. Last month, we announced positive top line results that demonstrated the efficacy and safety of Effexor for the treatment of generalized anxiety disorder or GAD in Japanese patients with moderate to severe disease. We believe this significant life cycle opportunity has the potential to be a meaningful treatment option for patients with GAD, a condition which currently does not have any approved treatment available in Japan. We are targeting to submit our application to the Japanese health authorities in 2025.

埃法索就是一個很好的例子。上個月，我們宣布了積極的頂線結果，證明 Effexor 用於治療日本中重度疾病患者的廣泛性焦慮症或 GAD 的有效性和安全性。我們相信，這個重要的生命週期機會有可能成為廣泛性焦慮症患者的一種有意義的治療選擇，目前日本還沒有任何批准的治療方法。我們的目標是在 2025 年向日本衛生當局提交申請。

The growth of our base business is critical for us to be able to reinvest in our innovative pipeline as we look for opportunities which can make a meaningful difference in patients' lives. We also have the unique opportunity to leverage our global development expertise and broad commercial infrastructure.

我們的基礎業務的成長對於我們能夠對我們的創新管道進行再投資至關重要，因為我們正在尋找能夠對患者的生活產生有意義的改變的機會。我們還有獨特的機會來利用我們的全球開發專業知識和廣泛的商業基礎設施。

[PETs] like sotagliflozin or INPEFA represent a good strategic fit for us. INPEFA was previously approved by FDA to reduce the risk of cardiovascular death, hospitalization for heart failure and urgent heart failure visits in adults with heart failure or type 2 diabetes, chronic kidney disease and other cardiovascular risk factors.

sotagliflozin 或 INPEFA 等 [PET] 非常適合我們的策略。INPEFA 先前已獲得 FDA 批准，用於降低心臟衰竭或 2 型糖尿病、慢性腎臟病和其他心血管危險因子的成人的心血管死亡、心臟衰竭住院和緊急心臟衰竭就診的風險。

We believe that INPEFA is a differentiated asset that offers a broader label compared to SGLT2 inhibitors and a unique mechanism of action with dual SGLT inhibition potentially contributing to the unique safety and efficacy profile of the drug.

我們相信，INPEFA 是一種差異化資產，與 SGLT2 抑制劑相比，它提供了更廣泛的標籤，並且具有雙重 SGLT 抑制的獨特作用機制，可能有助於該藥物獨特的安全性和有效性。

Our plan is to leverage the FDA approval as a reference in certain ex-US markets, and conduct clinical studies were needed to expand patients reach. We also believe there is a potential for expansion into further indications, which could include hypertrophic cardiac myopathy.

我們的計劃是利用 FDA 的批准作為某些美國以外市場的參考，並進行必要的臨床研究以擴大患者範圍。我們也相信有可能擴展到更多適應症，其中可能包括肥厚性心肌病變。

Further, Viatris has a strong legacy in cardiovascular diseases through our portfolio that expands across the overall cardiovascular continuum from reducing risk factors to improving patient outcomes with well-known products like Lipitor, Norvasc and CADUET, in addition to our expertise in the area of thrombosis with products like Arixtra and Fraxiparine. With this legacy and broad portfolio also comes very strong relationship with the medical community, which we're tapping into as we progress our selatogrel program.

此外，Viatris 透過我們的產品組合在心血管疾病領域擁有強大的傳統，除了我們在血栓形成領域的專業知識外，我們的產品組合還擴展到整個心血管領域，從減少風險因素到透過立普妥、絡活喜和CADUET 等知名產品改善病患治療結果與 Arixtra 和 Fraxiparine 等產品一起使用。憑藉這一傳統和廣泛的產品組合，我們還與醫學界建立了非常牢固的關係，我們在推進 selatogrel 項目時正在利用這種關係。

I've provided details about selatogrel and cenerimod on our last call but let me share a brief status update. Our recruitment effort for both are SMI clinical trials and our OPUS clinical trial are progressing well. The development for each asset is on track and aligned to our previous communicated timelines.

我在上次通話中提供了有關 selatogrel 和 cenerimod 的詳細信息，但讓我分享簡短的狀態更新。我們的 SMI 臨床試驗和 OPUS 臨床試驗的招募工作進展順利。每項資產的開發均按計劃進行，並與我們先前溝通的時間表保持一致。

In addition, we are working on expanding cenerimod indications by initiating a registration program in lupus nephritis. And finally, as part of our innovative pipeline, we are continuing to advance our ophthalmology program with three key registrational readouts expected in 2025.

此外，我們正在透過啟動狼瘡性腎炎的註冊計劃來擴大 cenerimod 的適應症。最後，作為我們創新管道的一部分，我們將繼續推進我們的眼科項目，預計將於 2025 年發布三個關鍵的註冊結果。

I'm proud of the work to date across our entire R&D platform and believe we'll continue to make an impact for many years to come by harnessing the combination of both our base business and innovative pipeline.

我對我們整個研發平台迄今為止所做的工作感到自豪，並相信我們將透過利用我們的基礎業務和創新管道的結合，在未來的許多年裡繼續產生影響。

And with that, I'll turn it over to Doretta.

有了這個，我會把它交給多雷塔。

Thank you, Philippe, and good morning, everyone. Building on Scott's earlier comments, this has been an exceptionally strong quarter and our first full quarter on an ex-divestiture basis. The results of which are highly encouraging and indicative of the strong momentum we anticipate carrying into the new year.

謝謝你，菲利普，大家早安。根據斯科特之前的評論，這是一個異常強勁的季度，也是我們在剝離前的第一個完整季度。其結果非常令人鼓舞，顯示我們預計新的一年將保持強勁勢頭。

We're pleased to report our diversified base business grew 3% year over year, marking our sixth consecutive quarter of operational revenue growth. This performance also carried through to adjusted EBITDA and adjusted earnings per share, which grew approximately 4% and 6%, respectively.

我們很高興地報告我們的多元化基礎業務年增 3%，標誌著我們的營業收入連續第六個季度成長。這一業績也體現在調整後 EBITDA 和調整後每股收益上，分別成長約 4% 和 6%。

We generated significant free cash flow of $866 million, excluding the impact of transaction costs and taxes, which enabled us to continue strengthening the balance sheet by paying down debt. Going forward, we have a strong foundation to execute on our three strategic pillars.

扣除交易成本和稅收的影響，我們產生了 8.66 億美元的大量自由現金流，這使我們能夠透過償還債務繼續強化資產負債表。展望未來，我們擁有執行三大戰略支柱的堅實基礎。

As I review the highlights for the quarter, to note, my commentary on segment performance will be on a divestiture-adjusted operational basis. Growth of our base business revenue was up 3% year over year. And once again, all of our segments grew versus the prior year.

在我回顧本季的亮點時，需要注意的是，我對部門績效的評論將基於資產剝離調整後的營運基礎。我們的基礎業務收入年增 3%。我們所有的細分市場再次與前一年相比有所成長。

We had strong performance from brands, up 2% and from generics, up 4%. Brand performance included expansion of our cardiovascular portfolio in certain Latin American countries and strong growth in Europe and Greater China.

我們的品牌表現強勁，成長了 2%，仿製藥成長了 4%。品牌表現包括在某些拉丁美洲國家擴大我們的心血管產品組合以及在歐洲和大中華區的強勁成長。

Generics growth was attributable to strength in our broader European portfolio, complex products in North America and strong volume performance across the JANZ region. New product revenue was $133 million for the quarter, bringing the total to $497 million year to date. We remain confident we will be at the higher end of our range of $500 million to $600 million for the year.

仿製藥的成長歸功於我們更廣泛的歐洲產品組合的實力、北美的複雜產品以及整個 JANZ 地區強勁的銷售表現。該季度新產品收入為 1.33 億美元，使年初至今的總收入達到 4.97 億美元。我們仍有信心今年的營收將達到 5 億至 6 億美元的上限。

In developed markets, net sales grew by approximately 3% and driven by robust strength in our generics business. In Europe, we saw another quarter of durable growth across our diversified business, up 6%, driven by contributions from new products and strong generics performance in key countries, including France. In North America, we saw another quarter of growth in generics, up 5%, benefiting from complex products such as Breyna and Wixela as well as from lisdexamfetamine.

在已開發市場，受我們仿製藥業務強勁實力的推動，淨銷售額成長了約 3%。在歐洲，我們的多元化業務又實現了一個季度的持續成長，成長了 6%，這得益於新產品和包括法國在內的主要國家的仿製藥強勁表現的貢獻。在北美，由於 Breyna 和 Wixela 等複雜產品以及賴右苯丙胺，我們看到仿製藥又成長了一個季度，成長了 5%。

Within our brands business, Net sales declined from the continued impact of Medicaid utilization in certain non-promoted brands and lower EpiPen volumes resulting from the formulary changes which occurred earlier in the year.

在我們的品牌業務中，由於某些非促銷品牌的醫療補助使用的持續影響以及今年稍早發生的處方變化導致 EpiPen 銷售下降，淨銷售額有所下降。

In Greater China, net sales grew approximately 3% over the prior year. This was as a result of continued strong volume growth across multiple channels, including e-commerce, retail and hospitals. In emerging markets, net sales grew 2%, driven by the expansion of our branded cardiovascular portfolio in certain Latin American countries and strength in our MENA and emerging Asia regions. These benefits helped to absorb supply chain impacts affecting our ARV generics business.

在大中華區，淨銷售額較上年成長約3%。這是由於電子商務、零售和醫院等多個管道的銷售持續強勁增長的結果。在新興市場，淨銷售額成長了 2%，這得益於我們品牌心血管產品組合在某些拉丁美洲國家的擴張以及我們在中東和北非地區以及新興亞洲地區的實力。這些好處有助於吸收影響我們抗愛滋病毒仿製藥業務的供應鏈影響。

And lastly, JANZ grew approximately 8% benefiting from new products in Australia and volume growth from our promoted brands in Japan.

最後，受益於澳洲的新產品和我們在日本推廣的品牌的銷售成長，JANZ 成長了約 8%。

Turning to the P&L and cash flow. Adjusted gross margin was stable at approximately 58.5%, and operating expenses were roughly flat over the prior year, both in line with our expectations. Free cash flow for the quarter, excluding transaction costs and taxes grew 10%, driven by higher adjusted EBITDA and lower working capital. This significant free cash flow and cash from divestitures enabled us to continue executing on our debt repayment plan.

轉向損益表和現金流量。調整後毛利率穩定在58.5%左右，營業費用與去年基本持平，均符合我們的預期。受調整後 EBITDA 增加和營運資本減少的推動，本季自由現金流（不包括交易成本和稅收）增加了 10%。這種大量的自由現金流和資產剝離現金使我們能夠繼續執行我們的債務償還計劃。

We repaid $1.9 billion of debt including the $325 million that was repaid in October, bringing our notional debt outstanding below $15 billion and line of sight to below $14 billion by year-end. Following the upcoming repayment of approximately EUR1 billion at maturity in November, we expect to exit the year at approximately 3 times gross leverage. And we will have successfully completed our deleverage and achieved meeting our long-term gross leverage target at year-end.

我們償還了 19 億美元的債務，其中包括 10 月償還的 3.25 億美元，使我們的未償名目債務低於 150 億美元，預計到年底將低於 140 億美元。繼 11 月到期償還約 10 億歐元後，我們預計今年退出時的總槓桿率約為 3 倍。年底我們將順利完成去槓桿，實現長期總槓桿目標。

Going forward, we plan to operate within our long-range target of 2.8 to 3.2 times. This positions the company with a meaningfully stronger balance sheet and a continuing investment grade rating, all of which will serve as the foundation of our capital allocation decisions going into next year and beyond.

展望未來，我們計劃在 2.8 至 3.2 倍的長期目標內運作。這使該公司擁有更強勁的資產負債表和持續的投資評級，所有這些都將成為我們明年及以後資本配置決策的基礎。

Turning to the remainder of the year. We are reaffirming our outlook with full year 2024 base business operational revenue growth of approximately 2% and flat adjusted EBITDA and adjusted earnings per share versus last year. We have revised these earnings ranges solely to reflect the impact of IP R&D related to the sotagliflozin licensing agreement incurred in October.

轉向今年剩下的時間。我們重申我們的展望，2024 年全年基本業務營運收入成長約 2%，調整後 EBITDA 和調整後每股盈餘與去年持平。我們修改這些收益範圍只是為了反映與 10 月發生的 sotagliflozin 授權協議相關的智慧財產權研發的影響。

A few comments on sequential phasing for the fourth quarter. Total revenue is expected to be lower for the following reasons: normal product seasonality in developed markets and Greater China region, phasing of certain generic products in North America, and generic entrants in our cardiovascular products in JANZ.

關於第四季度順序階段的一些評論。總收入預計將較低，原因如下：已開發市場和大中華地區的正常產品季節性、北美的某些仿製藥產品的逐步推出以及 JANZ 心血管產品的仿製藥進入。

Adjusted EBITDA and adjusted earnings per share will be impacted by a step down in adjusted gross margin due to normal product and segment mix and an increase in adjusted SG&A due to timing and normal cadence of investment.

調整後 EBITDA 和調整後每股盈餘將受到正常產品和細分市場組合導致的調整後毛利率下降以及投資時機和正常節奏導致調整後銷售及管理費用增加的影響。

And lastly, free cash flow in the fourth quarter is also expected to be lower due to the impact from divestiture costs and taxes, higher CapEx and semi-annual interest payments. I would note that these trends are all consistent with our expectations and prior periods.

最後，由於剝離成本和稅收、資本支出增加和半年利息支付的影響，第四季度的自由現金流預計也會較低。我要指出的是，這些趨勢都符合我們的預期和先前的時期。

In summary, we believe these results demonstrate our encouraging fundamentals from our diversified and growing base business which continues to produce significant free cash flow. The prudent work we have done on strengthening the balance sheet provides us with a strong foundation as we pivot to a more balanced capital allocation strategy of funding our vision and returning capital to shareholders.

總之，我們相信這些結果證明了我們多元化和不斷增長的基礎業務的令人鼓舞的基本面，該業務繼續產生大量的自由現金流。我們在加強資產負債表方面所做的審慎工作為我們轉向更平衡的資本配置策略，為我們的願景提供資金並將資本返還給股東奠定了堅實的基礎。

But before I conclude, given the level of investor interest in modeling our selatogrel and cenerimod assets, we are providing a workbook as part of our Q3 earnings package that can be found on our investor website.

但在我得出結論之前，考慮到投資者對我們的selatogrel 和cenerimod 資產建模的興趣程度，我們將提供一本工作簿作為我們第三季度收益方案的一部分，可以在我們的投資者網站上找到。

And with that, I'll hand it back to the operator to begin the Q&A.

然後，我會將其交還給操作員以開始問答。

(Operator Instructions) Glen Santangelo, Jefferies.

（操作員說明）Glen Santangelo，Jefferies。

Scott, I have just two quick questions for you. The first one is a lot of comments around the base business continuing to have strong momentum and that sort of continuing into '25. And I appreciate you don't want to give any forward guidance, but when we look out over the next couple of years, is that sort of $500 million contribution from new product revenues? You're obviously generating a little more than that this year. But is that sort of the right ZIP code for us to think about as a starting point for the next couple of years?

史考特，我只有兩個簡單的問題想問你。第一個是圍繞基礎業務的大量評論，該業務繼續保持強勁勢頭，並且這種勢頭一直持續到 25 年。我很高興您不想提供任何前瞻性指導，但當我們展望未來幾年時，新產品收入是否會貢獻 5 億美元？今年你的收入顯然比這多一點。但這種郵遞區號是否適合我們作為未來幾年的起點呢？

And then secondly, on the capital allocation, the company said repeatedly that you want to use half the free cash flow for business development and the other half, you want to return to shareholders through repurchases and dividends.

其次，在資本配置上，公司多次表示，要將一半的自由現金流用於業務發展，另一半則透過回購和分紅來回報股東。

Is sort of getting the leverage down to 3 times by the end of the year, is that the trigger to start that? And based on what you see in the market with respect to business development versus Viatris trading at only 6 times EBITDA, does that push you one way or another as you move into '25?

到年底槓桿率是否會降至 3 倍，這是啟動這項措施的觸發因素嗎？根據您在市場上看到的業務發展情況，以及 Viatris 的交易價格僅為 EBITDA 的 6 倍，當您進入 25 世紀時，這是否會以某種方式推動您？

Thank you very much for the questions, Glenn. So for the first one, yes, with the base business, we're not guiding it to '25, but we see the base business continuing to generate and continuing to have momentum similar to what we have this year. We think we can generate, and we have historically, since 2020, generated $450 million to $550 million in new product revenue every year, and we expect that to continue.

非常感謝你的提問，格倫。因此，對於第一個目標，是的，對於基礎業務，我們不會將其引導到 25 年，但我們看到基礎業務繼續產生並繼續保持與今年類似的勢頭。我們認為我們可以創造，而且自 2020 年以來，我們每年每年創造 4.5 億至 5.5 億美元的新產品收入，我們預計這種情況將持續下去。

And yes, to your second question on capital allocation, I think getting to 3 times is very, very important for us. That will allow us to be able to use $2.3 billion in free cash flow at minimum to give half back to shareholders through dividends and share buybacks.

是的，關於你關於資本配置的第二個問題，我認為達到 3 倍對我們來說非常非常重要。這將使我們能夠利用至少 23 億美元的自由現金流，透過股息和股票回購將一半返還給股東。

We're trying to be more aggressive on share buybacks as we move into '25 and beyond because we'll be at that desired leverage ratio. And we want to also be doing some disciplined business development, focusing on in-market or near-market assets. So yes, getting into '25, getting that leverage ratio right really is a springboard for us to be able to execute on our capital allocation strategy in '25 and beyond.

當我們進入 25 年及以後時，我們正努力更積極地進行股票回購，因為我們將達到理想的槓桿率。我們也希望進行一些嚴格的業務開發，並專注於市場內或近市場資產。所以，是的，進入 25 年，保持正確的槓桿率確實是我們能夠在 25 年及以後執行我們的資本配置策略的跳板。

Jason Gerberry, Bank of America.

傑森‧格伯里，美國銀行。

A couple for me. We saw one multinational company operating in China recently get investigated regarding some reimbursement matters. I'm just trying to get a sense from your perspective, if that's an isolated incident or if this is part of some broader effort around cracking down on different reimbursement practices. Just it would be helpful if you can just offer any color around that?

給我一對。我們看到一家在中國經營的跨國公司最近因一些報銷問題而受到調查。我只是想從您的角度了解一下，這是否是一個孤立的事件，或者這是圍繞打擊不同報銷做法的更廣泛努力的一部分。如果您能提供周圍的任何顏色，會有幫助嗎？

And then I didn't -- apologies if I didn't hear this, but were there any updates just thinking about Sandostatin LAR and a potential to get that approved in the near term and status of the GA Depot resubmission?

然後我沒有——如果我沒有聽到這個，我很抱歉，但是是否有任何關於 Sandostatin LAR 的更新以及在短期內獲得批准的潛力以及 GA Depot 重新提交的狀態？

Thank you, Jason. I'll take the first question on China, and then Philippe can fill you in on your new product question. So we don't have any direct comment on any investigation that's going on in another country. We as a leadership team were just in China last week and meeting with the affiliate there.

謝謝你，傑森。我將回答關於中國的第一個問題，然後菲利普可以回答您的新產品問題。因此，我們對另一個國家正在進行的任何調查沒有任何直接評論。作為領導團隊，我們上週剛在中國與那裡的附屬公司會面。

As an organization, we hold ourselves to the highest standards possible. We've got a strong compliance organization in China. We've got strong overall structure in China and a very strong affiliate. We've developed deep and strong partnerships within the health care community there. And we feel very, very strongly about our business in China.

作為一個組織，我們要求自己盡可能達到最高標準。我們在中國擁有強大的合規組織。我們在中國擁有強大的整體結構和非常強大的附屬機構。我們在那裡的醫療保健界建立了深厚而牢固的合作關係。我們對我們在中國的業務感覺非常非常強烈。

And this is Philippe regarding your second question. GA Depot, we have a meeting scheduled with the agency in mid-December. And so we'll be in a better place to give you an update next year once we hear from this meeting with the FDA.

這是菲利普關於你的第二個問題。GA Depot，我們計劃在 12 月中旬與該機構舉行會議。因此，一旦我們收到與 FDA 的這次會議的消息，明年我們將能夠更好地向您提供最新資訊。

And then regarding -- I think your question was about Sandostatin. Yes, we are still going through FDA review for this product, and we expect we'll be in a position to launch the product at some point next year.

然後關於──我認為你的問題是關於善寧的。是的，我們仍在接受 FDA 對該產品的審查，我們預計我們將能夠在明年的某個時候推出該產品。

Chris Schott, JPMorgan.

克里斯‧肖特，摩根大通。

This is Ethan on for Chris. First off, just -- if we look at the deals that you've done this year between the Idorsia and SGLT2 transactions, is this the type of deals that we should expect going forward in terms of size and scale? And then secondly, just looking to 2025, any initial color on your 2025 expectations for EBITDA and how we should be thinking about the pushes and pulls there?

這是伊森替克里斯發言。首先，如果我們看看今年在 Idorsia 和 SGLT2 交易之間進行的交易，從規模和規模來看，這是我們應該期待的交易類型嗎？其次，展望 2025 年，您對 2025 年 EBITDA 的預期有什麼初步的看法，以及我們應該如何考慮那裡的推動和拉動？

Yes. Thank you, Ethan, for the question. And I'll take the first one and then I'll push to Doretta to talk to you about EBITDA going forward. The Idorsia transaction was a little bit of a transaction of opportunity. It's a little bit of an earlier deal than I think it will be normal for us going forward.

是的。謝謝伊森提出的問題。我會選擇第一個，然後我會催促 Doretta 與您討論未來的 EBITDA。Idorsia 交易可以說是一次機會交易。這是一個比我認為對我們未來來說正常的交易更早的交易。

These were our products that were in Phase III development, I think, very, very good positive assets. We felt like we contribute to the continued development of them. We think they've got the potential to be blockbusters if the data comes in positive globally. So that was a deal of opportunity for us. I think we're really focused right now on doing disciplined business development.

我認為這些是我們處於第三階段開發的產品，是非常非常好的正面資產。我們覺得我們為他們的持續發展做出了貢獻。我們認為，如果全球數據積極，它們就有可能成為重磅炸彈。所以這對我們來說是一個很好的機會。我認為我們現在真正專注於進行有紀律的業務發展。

We want to really focus in-end market or near-market assets, things which we can leverage our global health care gateway. We've got a very strong global infrastructure. We want to be able to deliver assets that can drive some revenue in the '25, '26, '27 time frame.

我們希望真正專注於終端市場或近市場資產，我們可以利用我們的全球醫療保健網關。我們擁有非常強大的全球基礎設施。我們希望能夠提供能夠在 25 年、26 年、27 年時間範圍內帶來一些收入的資產。

So -- and in terms of size of the deal, yes, I think we're -- that's the type of deal we're looking. We're -- I think we're hoping to add multiple different assets over the next couple of years to the pipeline. And again, we're focusing on very disciplined business development with in-market or near-market assets.

所以 - 就交易規模而言，是的，我認為 - 這就是我們正在尋找的交易類型。我認為我們希望在未來幾年內向管道中添加多種不同的資產。再說一次，我們專注於利用市場內或接近市場的資產進行非常嚴格的業務開發。

Thanks on 2025 questions. Yes, we're not going to be providing forward-looking revenue and EBITDA guidance. But just to your point, just to give you a sense of some of the pushes and pulls. As Scott commented earlier on the momentum that we're continuing to see from the base business on the revenue perspective and how we expect that to continue at the top line.

感謝您提出 2025 年問題。是的，我們不會提供前瞻性收入和 EBITDA 指導。但就你的觀點而言，只是為了讓你感受到一些推力和拉力。正如斯科特早些時候評論的那樣，我們從基礎業務的收入角度繼續看到這種勢頭，以及我們預計這種勢頭將如何在營收上繼續下去。

From an EBITDA and EPS perspective, we are currently working through the adjustments post the divestitures from a stranded cost TSA perspective. But going into next year, we are focused on really prioritizing adjusted EBITDA stability. And so we're really balancing the growth of the business but making the necessary investments in R&D and commercial that can drive our future growth.

從 EBITDA 和 EPS 的角度來看，我們目前正在從 TSA 擱淺成本的角度進行資產剝離後的調整。但進入明年，我們的重點是真正優先考慮調整後的 EBITDA 穩定性。因此，我們確實在平衡業務成長，但在研發和商業方面進行必要的投資，以推動我們未來的成長。

And I would say we'll continue to work and provide clarity and provide really an apples-to-apples comparison when we provide our '25 guidance. But we do see things reasonably calibrated in the models, and we also feel confident in our cash flow of $2.3 billion, and we'll provide more color as we get into next year.

我想說，當我們提供 '25 指南時，我們將繼續努力並提供清晰度並提供真正的同類比較。但我們確實看到模型中的東西得到了合理的校準，我們也對 23 億美元的現金流充滿信心，進入明年我們將提供更多的色彩。

Ash Verma, UBS.

阿什‧維爾瑪，瑞銀集團。

Good to see some steady progress here. Just a capital allocation question. So with bulk of the debt paydown that you were sort of driving towards behind you and the stock trading at like sub 4 times run rate EPS, like how do you think about balancing business development investment and share repurchases?

很高興看到這裡取得了一些穩定進展。只是一個資本配置問題。因此，隨著您推動的大部分債務償還以及股票交易價格低於每股收益的 4 倍，您如何考慮平衡業務發展投資和股票回購？

And then secondly, for emerging markets, yes, I saw this like ARV supply chain impact. I think you have talked about this for a little bit of time. Just curious like when does this start to lap that we don't see this as a drag on the business going forward?

其次，對於新興市場，是的，我看到了抗愛滋病毒藥物供應鏈的影響。我想你已經談論這個問題有一段時間了。只是好奇這種情況什麼時候開始出現，我們不認為這會拖累未來的業務？

Thanks, Ash. And I'll take your first question again, and Doretta can pick up your second question. Yes, we've got line of sight on getting our debt repayment rate to the right spot of the target that we have talked about at a leverage ratio of approximately 3 and 3.0. And we see that very, very closely to us, and we've got great line of sight on that.

謝謝，阿什。我將再次回答你的第一個問題，多雷塔可以回答你的第二個問題。是的，我們的目標是使我們的債務償還率達到我們所討論的目標的正確位置，槓桿率約為 3 和 3.0。我們非常非常密切地看到這一點，並且我們對此有很好的視野。

That definitely then allows us to move into our capital allocation, implementing the full capital allocation strategy, minimum of $2.3 billion in free cash flow, half of that to shareholders in terms of dividend and share buyback. The other half in terms of business development and building the pipeline, doing that in a disciplined way.

這無疑使我們能夠進入資本配置，實施全面的資本配置策略，至少 23 億美元的自由現金流，其中一半用於股息和股票回購。另一半是業務開發和管道建設，以嚴格的方式進行。

I think given the share price and the valuation of the company right now, we might be a little more aggressive on the share buyback side than on the BD side going into '25. But we're looking at a three, four, five-year period where approximately half going to return to shareholders and half to BD. But I think implicit in your point is this idea of the valuation of the company and given that I think we see a nice opportunity as we move into '25 to be more aggressive in terms of share buybacks.

我認為考慮到公司目前的股價和估值，進入 25 年，我們在股票回購方面可能會比在 BD 方面更加積極。但我們正在考慮三年、四年、五年，其中大約一半將返還給股東，另一半將返還給 BD。但我認為你的觀點中隱含著公司估值的想法，而且我認為，隨著我們進入 25 年，我們看到了一個很好的機會，可以在股票回購方面更加積極地進行。

And with respect to the ARV business, historically, we have made comments around just therapy shifts that have been ongoing in the business. However, my comments this quarter were really specific to some delays that we saw in the supply of ARV products. And we are currently working to catch up on those backlogs across ARV and across our ARV portfolio, and that's what we're working through. That's -- those are what my comments were referring to.

關於抗逆轉錄病毒藥物業務，從歷史上看，我們只是圍繞著該業務中正在進行的治療轉變發表了評論。然而，我本季的評論實際上是針對我們在抗逆轉錄病毒產品供應方面看到的一些延遲。我們目前正在努力解決抗逆轉錄病毒藥物和抗逆轉錄病毒藥物組合中的積壓問題，這就是我們正在解決的問題。這就是我的評論所指的內容。

(Operator Instructions) David Amsellem, Piper Sandler.

（操作說明）David Amsellem、Piper Sandler。

Well, I don't want to belabor the topic of new launch contribution for '25. And I know that you've drilled down a little more because it does feel to me that there is less in the way of transparency regarding new products going forward than there has been historically.

好吧，我不想過多討論 25 年新發布貢獻的話題。我知道你已經深入了解了一些，因為我確實覺得未來新產品的透明度比歷史上少。

So one question I had is you've talked historically about products like Sandostatin LAR. You talked about Victoza as contributors. Can you talk to how much products like that are going to be contributors for next year? Other products like iron sucrose, Venofer, is that going to be a contributor? You talked about glucagon, injectable glucagon in the past. Is that going to be a contributor.

我的一個問題是，您歷史上曾談論過 Sandostatin LAR 等產品。您談到 Victoza 作為貢獻者。您能談談明年有多少這樣的產品將成為貢獻者嗎？其他產品，如蔗糖鐵、Venofer，會成為貢獻者嗎？您過去談到了胰高血糖素，注射用胰高血糖素。那會成為貢獻者嗎？

And then also, one of your competitors, Teva has talked about potentially entering the Symbicort market next year. I'm wondering if you can talk to potential competitive dynamics regarding Symbicort. So I know there's a lot there on specific products but hoping to get granularity.

此外，您的競爭對手之一 Teva 也談到了明年可能進入 Symbicort 市場的可能性。我想知道您是否可以談談有關 Symbicort 的潛在競爭動態。所以我知道有很多關於特定產品的信息，但希望能獲得更詳細的信息。

Thank you, David. Thank you for the question. And just from a macro level, we feel very good about the new product numbers. Traditionally, we have -- if you take a look over the last four or five years, we've delivered $450 million to $550 million in new product revenue every year. This year, we're at the high end of it.

謝謝你，大衛。謝謝你的提問。僅從宏觀層面來看，我們對新產品的數量感到非常滿意。傳統上，如果你看看過去四、五年，我們每年都會帶來 4.5 億至 5.5 億美元的新產品收入。今年，我們正處於高端。

we believe we're doing very, very well in terms of the number of submissions and the number of products approved overall. And we feel very confident in those numbers going forward. To get to your sort of specifics around individual products. I'll ask Philippe to comment.

我們相信，就提交數量和總體批准產品數量而言，我們做得非常非常好。我們對這些數字的未來非常有信心。了解有關各個產品的具體資訊。我會請菲利普發表評論。

Yes. Thank you, Scott. So I think as Scott said, we are very confident about $450 million to $550 million next year, and this includes carryover from 2024 generic launches in North America and Europe. And to your question specifically, it includes complex products such as glucagon, iron sucrose and liraglutide. So these three products are clearly in the mix for next year.

是的。謝謝你，斯科特。因此，我認為正如 Scott 所說，我們對明年的 4.5 億至 5.5 億美元非常有信心，其中包括 2024 年在北美和歐洲推出仿製藥的結轉資金。具體到你的問題，它包括複雜的產品，如胰高血糖素、蔗糖鐵和利拉魯肽。因此，這三種產品顯然會成為明年的產品組合。

And we are continuing to work on that broad portfolio and bring over a significant number of submissions every year. So again, we can only reiterate the fact that we are very confident about this $450 million to $550 million.

我們將繼續致力於這項廣泛的投資組合，每年都會收到大量的提交資料。因此，我們只能重申一個事實，就是我們對這 4.5 億至 5.5 億美元非常有信心。

And David, on your comment on additional generic competition on Symbicort in this area. What I can say is that, first, as you know, we are very pleased with the execution and the performance of Breyna, which is our complex generic that plays in this market.

David，關於您對 Symbicort 在這一領域的其他仿製藥競爭的評論。我能說的是，首先，正如你所知，我們對 Breyna 的執行和表現非常滿意，這是我們在這個市場上發揮作用的複雜仿製藥。

We have currently about 15% TRx market share, and we expect that Breyna will continue to deliver growth for us going into 2025. So again, a good example of having had the possibility to launch early as a complex generic in this market and to be able to deliver more durable and sustainable value.

目前我們擁有約 15% 的 TRx 市場份額，我們預計 Breyna 將在 2025 年繼續為我們帶來成長。這又是一個很好的例子，說明有可能在這個市場上儘早推出複雜的仿製藥，並且能夠提供更持久和可持續的價值。

Balaji Prasad, Barclays.

巴拉吉·普拉薩德，巴克萊銀行。

Just two sets of questions from me, and apologies if one of them are -- both have been asked earlier. Firstly, could you comment about sotagliflozin in terms of the contributions and the number of markets that you plan to launch in the next one to two years? And how should we think about modeling this into our thoughts?

我只提出了兩組問題，如果其中一組是的話，我深表歉意——這兩個問題都已經在早些時候被問過。首先，您能否評估sotagliflozin的貢獻以及您計劃在未來一兩年內推出的市場數量？我們應該如何考慮將其模型化到我們的想法中？

Secondly, a big picture thematic question. With the new administration, it's likely that we could see a pushback towards Make in America. I want to understand how could that change your priorities towards the US generics market? Is this something that you will want to refocus or increase in terms of focus and future revenue contributions from this region?

其次，一個大局主題問題。在新政府的領導下，我們很可能會看到「美國製造」受到阻礙。我想了解這會如何改變您對美國仿製藥市場的優先考慮？您是否希望重新關注或增加該地區的重點和未來收入貢獻？

Yes. Thank you, Balaji. And I'll take the macro question and then Philippe and Corinne can talk a little bit more about sotagliflozin. From a macro perspective, far too early for us to be able to fully understand health care implications. We're here.

是的。謝謝你，巴拉吉。我將回答宏觀問題，然後 Philippe 和 Corinne 可以更多地談論 sotagliflozin。從宏觀角度來看，我們現在還無法充分理解醫療保健的影響。我們到了。

We will work positively and productively with the Trump administration as we would with any administration going forward but it's far too early to understand health care implications at this point in time, but we're interested to understand what's ahead and very optimistic about what the years look like for us in '25 and beyond.

我們將與川普政府積極、有成效地合作，就像我們與未來的任何政府合作一樣，但現在了解醫療保健的影響還為時過早，但我們有興趣了解未來的情況，並對未來幾年的情況非常樂觀對於我們25年及以後的人來說是這樣的。

Regarding sota, I think we are -- what we're going to do is leverage the US approval and get the drug registered in several large emerging markets, Canada, Australia, New Zealand, for which there's a very clear straightforward path to approval. In Asian markets like Japan and China, it might require another clinical study.

關於 sota，我認為我們要做的是利用美國的批准，讓藥物在加拿大、澳洲、紐西蘭等幾個大型新興市場註冊，這些市場有一條非常明確、直接的批准途徑。在日本和中國等亞洲市場，可能需要另一項臨床研究。

And so we'll be discussing with the health authorities over the next few months and put a development plan together for this. So we expect that sota will start contributing to our revenue growth in around 2027, but I'll turn it over to Corinne for more color.

因此，我們將在接下來的幾個月內與衛生當局進行討論，並為此制定一項發展計劃。因此，我們預計 sota 將在 2027 年左右開始為我們的收入成長做出貢獻，但我會將其交給 Corinne 以獲取更多色彩。

Yes. Thank you. So I'm not going to comment on the overall size of the opportunity. But what I can say is that sotagliflozin fits perfectly with our cardiovascular infrastructure in the regions where we'll be launching this product. I mean you should know like we have about $2.5 billion of annual revenues in cardiovascular diseases.

是的。謝謝。因此，我不會評論機會的整體規模。但我可以說的是，sotagliflozin 與我們將推出該產品的地區的心血管基礎設施完美契合。我的意思是你應該知道我們在心血管疾病的年收入約為 25 億美元。

So we have in place the appropriate infrastructure to be able to promote these assets across the regions. And we look at the sotagliflozin as a franchise that will -- as Philippe said, starting revenue in year 2027, but will generate growth through the end of the decade.

因此，我們擁有適當的基礎設施，能夠在各個地區推廣這些資產。我們將 sotagliflozin 視為特許經營產品，正如 Philippe 所說，它將在 2027 年開始收入，但將在本世紀末實現成長。

And with that, ladies and gentlemen, we'll conclude today's question-and-answer session. I'd like to turn the floor back over to Scott Smith for closing remarks.

女士們、先生們，我們今天的問答環節就到此結束。我想請斯科特·史密斯做結束語。

Thank you very much and thank you for everybody on the call. In closing, it was another great quarter. I'm proud of our team of our continued strong performance. We have great momentum, and I'm looking forward to the future.

非常感謝您，也感謝參加電話會議的所有人。最後，這又是一個偉大的季度。我為我們團隊持續的強勁表現感到自豪。我們勢頭強勁，我對未來充滿期待。

With our leverage target insight and the strength of our balance sheet, our company is operating from a position of financial strength, and we have a clear and focused outlook that centers on capital allocation. Returning value to shareholders through dividends and share repurchase will remain a central element of optimizing and maximizing shareholder value.

憑藉我們對槓桿目標的洞察力和資產負債表的實力，我們公司的營運擁有雄厚的財務實力，並且我們對以資本配置為中心的清晰而專注的前景有信心。透過股利和股票回購向股東回報價值仍將是優化和最大化股東價值的核心要素。

We will balance this with making disciplined investments in regional and global business development to drive our future growth. Thank you all.

我們將平衡這一點，並在區域和全球業務發展方面進行嚴格的投資，以推動我們未來的成長。謝謝大家。

And ladies and gentlemen, with that, we'll conclude today's conference call. We thank you for joining. You may now disconnect your lines.

女士們、先生們，我們今天的電話會議就到此結束。我們感謝您的加入。現在您可以斷開線路。