(TEVA) 2023 Q3 法說會逐字稿

Hello, and welcome to the Q3 2023 Teva Pharmaceutical Industries Earnings Conference Call. My name is Alex, and I will be coordinating the call today. (Operator Instructions) I'll now hand over to your host, Ran Meir, SVP of Investor Relations. Please go ahead.

您好，歡迎參加梯瓦製藥工業 2023 年第三季財報電話會議。我叫亞歷克斯，今天我將協調通話。 （操作員指示）我現在將會議交給主持人投資者關係高級副總裁蘭·梅爾 (Ran Meir)。請繼續。

Thank you, Alex. Thank you, everyone, for joining us today. We hope you had an opportunity to review our press release, which was issued earlier this morning. A copy of this press release as well as a copy of the slides being presented on this call can be found website at tevapharm.com.

謝謝你，亞歷克斯。謝謝大家今天加入我們。我們希望您有機會閱讀我們今天早上早些時候發布的新聞稿。本新聞稿的副本以及本次電話會議中示範的投影片的副本可在 tevapharm.com 網站上找到。

Please review our forward-looking statements on Slide 2. Additional information regarding these statements and our non-GAAP financial measures is available on our earnings release and in our SEC Form 10-K and 10-Q.

請查看幻燈片 2 上的前瞻性聲明。有關這些聲明和我們的非 GAAP 財務指標的更多信息，請參閱我們的收益報告以及 SEC 表格 10-K 和 10-Q。

To begin today's call, Richard Francis, Teva's CEO, will provide an overview of Teva's Q3 results and business performance, recent events and our priorities going forward. Then Dr. Eric Hughes, our Head of R&D and Chief Medical Officer, will discuss progress on our innovative pipeline. Our CFO, Eli Kalif will follow up by reviewing the financial results in more detail, including our 2023 financial outlook. Joining Richard, Eric and Eli on the call today is Sven Dethlefs, Head of North America business, who will be available during the question-and-answer session that will follow the presentation. Please note that today's call will run approximately 1 hour.

在今天的電話會議中，Teva 執行長 Richard Francis 將概述 Teva 第三季的業績和業務表現、最近發生的事件以及我們未來的優先事項。然後我們的研發主管兼首席醫療官 Eric Hughes 博士將討論我們創新管道的進展。我們的財務長 Eli Kalif 將進一步詳細審查財務業績，包括我們 2023 年的財務展望。今天與 Richard、Eric 和 Eli 一起參加電話會議的是北美業務主管 Sven Dethlefs，他將出席演示後的問答環節。請注意，今天的通話將持續約 1 小時。

And with that, I will now turn the call over to Richard. Richard?

現在，我將把電話轉給理查德。理查德？

Thank you, Ran, and thank you, everybody, for joining us today. I'd like to begin by saying that we are deeply saddened by the terror attacks in Israel on October 7. Since that day, Teva's Board, the leadership team and I have made the safety and well-being of our Israeli colleagues, our utmost priority. I visited and met employees at the facilities in Israel immediately after the attack. Many of them have families and friends who have perished or been kidnapped. What really stood out and inspired me was that despite all the difficulties they are running together to bring medicines to the patients who need them, especially now. I am personally humbled by their incredible resilience, care and sense of purpose.

謝謝蘭，也謝謝大家今天加入我們。首先，我想說，我們對 10 月 7 日在以色列發生的恐怖攻擊深感悲痛。自那天起，Teva 董事會、領導團隊和我一直將以色列同事的安全和福祉視為我們最大的責任。優先事項。攻擊發生後，我立即拜訪並會見了以色列工廠的員工。他們中許多人的家人和朋友已經遇難或被綁架。真正讓我印象深刻並激勵我的是，儘管面臨種種困難，他們仍然齊心協力，為有需要的患者提供藥品，尤其是現在。我個人對他們令人難以置信的韌性、關懷和使命感感到謙卑。

Now we have increased support of our emergency supply of medicines to hospitals, pharmacies and patients and we have partnered with our long-standing partners to donate products and provide other humanitarian aid. Through it all, our production remains largely unaffected and gratefully, none of our sites have incurred direct damage as a result of the war. We continue to secure contingency plans to be certain we can maintain our business continuity while most importantly, taking care to ensure that our colleagues are safe and well in these difficult times.

現在，我們加強了對醫院、藥房和患者緊急藥品供應的支持，並與我們的長期合作夥伴合作，捐贈產品並提供其他人道主義援助。儘管如此，我們的生產基本上沒有受到影響，值得慶幸的是，我們的工廠都沒有因戰爭而遭受直接損壞。我們繼續制定應急計劃，以確保我們能夠保持業務連續性，同時最重要的是，請注意確保我們的同事在這些困難時期的安全和健康。

Now moving on to Slide 5. I'd like to update you on strong performance in Q3 as we continue to execute or pivot to growth strategy. Now our strong performance of our growth was delivered by our growth engines, AUSTEDO, AJOVY and our generics business. Revenues were up 7% in U.S. and in local currency. Our gross margin continues to improve. We saw an increase by 50 basis points versus Q3 2022. We're pleased to announce the exciting partnership with Sanofi in Q3, a deal to really maximize our TL1-A asset. Because of these results, I'm pleased to announce that we're going to increase our outlook of revenue to $15.1 billion to $15.5 billion for 2023.

現在轉到投影片 5。隨著我們繼續執行或轉向成長策略，我想向您介紹第三季強勁業績的最新情況。現在，我們的強勁成長表現是由我們的成長引擎 AUSTEDO、AJOVY 和我們的仿製藥業務帶來的。以美國和當地貨幣計算的收入成長了 7%。我們的毛利率持續改善。與2022 年第三季相比，我們看到成長了50 個基點。我們很高興宣佈在第三季與賽諾菲建立令人興奮的合作夥伴關係，這項交易真正最大化了我們的TL1- A 資產。鑑於這些結果，我很高興地宣布，我們將把 2023 年的營收預期提高到 151 億美元至 155 億美元。

Now to move on to the next slide. We continue to maybe update you on our pivot to growth strategy. As you all remember, this was based on 4 pillars: deliver on our growth engines, step up innovation, sustain a generics powerhouse and focus our business. So I was going to touch on some of the progress we've made in Q3.

現在轉到下一張投影片。我們可能會繼續向您通報我們轉向成長策略的最新情況。大家都記得，這是基於四大支柱：提供我們的成長引擎、加強創新、維持仿製藥強國並專注於我們的業務。因此，我打算談談我們在第三季取得的一些進展。

As I've just mentioned, AUSTEDO is performing well and is on track to hit $1.2 billion for 2023, and we remain committed and confident of hitting the target of $2.5 billion in 2027. UZEDY was launched earlier in the year, and I'll give you an update on that. And we're pleased to announce with our partner, Alvotech that were doing an FDA inspection in early Q1 in 2024, it raises the opportunity that we may be able to launch Humira next year.

正如我剛才提到的，AUSTEDO 表現良好，預計在 2023 年達到 12 億美元的目標，我們仍然致力於並有信心在 2027 年實現 25 億美元的目標。UZEDY 於今年早些時候推出，我將向您通報最新情況。我們很高興地與我們的合作夥伴 Alvotech 一起宣布，該公司將於 2024 年第一季初進行 FDA 檢查，這為我們明年推出 Humira 提供了機會。

With regard to innovation, I'm joined on this call by Eric Hughes, we'll go into more detail. But a couple of highlights are obviously around olanzapine, our long-acting treatment for schizophrenia in the Phase III study. This is progressing really well and ahead of schedule. So we're confident we'll be able to report results in that -- in the second half of next year.

關於創新，艾瑞克休斯（Eric Hughes）也參加了這次電話會議，我們將討論更多細節。但有幾個亮點顯然是圍繞著奧氮平的，奧氮平是我們在 III 期研究中治療精神分裂症的長效藥物。這進展非常順利且提前了。因此，我們有信心在明年下半年報告這方面的結果。

To have a generics powerhouse, we made good progress as you'll see, we have growth across all of our regions.

為了成為仿製藥巨頭，我們取得了良好的進展，正如您所看到的，我們在所有地區都實現了成長。

And then finally, on Pillar 4, focus our business, we continue to do the work to create a stand-alone business unit to Teva api, I'm pleased to announce the appointment of our CEO for that business that allows them to compete in a global market.

最後，在第四支柱上，集中我們的業務，我們繼續努力為 Teva api 創建一個獨立的業務部門，我很高興地宣布任命我們的執行長負責該業務，使他們能夠在全球市場。

And moving on to the next slide, just to touch upon what are the news we had in Q3, the exciting collaboration with Sanofi. I'm pleased with this collaboration because it really strengthens our pivot to growth strategy. It allows us to partner with a global leader in immunology, both from an R&D and commercial perspective, while retaining the economics going forward, which is important as we want to drive long-term growth for Teva. We see this asset as an asset that can drive long-term growth because of the size of the market will be operated in. I'll come to that a bit later on.

轉到下一張投影片，簡單介紹一下我們在第三季獲得的新聞，即與賽諾菲的令人興奮的合作。我對這次合作感到高興，因為它確實加強了我們的成長策略。它使我們能夠從研發和商業角度與免疫學領域的全球領導者合作，同時保持未來的經濟效益，這對我們希望推動 Teva 的長期成長非常重要。我們認為該資產是一種可以推動長期成長的資產，因為其營運的市場規模很大。我稍後會談到這一點。

Now back to performance on the next slide. As I said, we had strong performance in Q3. Revenue was $3.9 billion, up 7%. That was driven by both our innovative business as well as our generics business. AUSTEDO continued its impressive growth, up 30%, while AJOVY continues to grow well at 22%. Pleased to show that we saw growth across all of our regions, with particularly strong performance in the U.S. and international markets.

現在回到下一張投影片的表演。正如我所說，我們在第三季表現強勁。營收為 39 億美元，成長 7%。這是由我們的創新業務和仿製藥業務推動的。 AUSTEDO 持續保持令人印象深刻的成長，成長 30%，而 AJOVY 繼續保持強勁成長，成長 22%。很高興地表明，我們在所有地區都看到了成長，其中在美國和國際市場的表現尤其強勁。

Now to double click and dive a bit deeper, I'd like to move on to AUSTEDO. AUSTEDO, once again, we confirm that we're committed to the $1.2 billion target for 2023. Revenue was up to $339 million for Q3, up 30%. And support and underpinned by good strong TRx growth of 29%.

現在，雙擊並更深入地了解一下，我想繼續討論 AUSTEDO。 AUSTEDO，我們再次確認，我們致力於實現 2023 年 12 億美元的目標。第三季營收高達 3.39 億美元，成長 30%。並受到 29% 的強勁 TRx 成長的支持和支撐。

Now on the next slide, I want to reiterate our commitment to the $2.5 billion target for 2027. We're doing this by investing in our brand and building capability of the company. As we mentioned earlier in the year, we have increased our sales force. We have invested in improving our patient support services as well as looking to launch this brand into the European market by 2026.

現在，在下一張幻燈片中，我想重申我們對 2027 年 25 億美元目標的承諾。我們透過投資品牌和建立公司能力來實現這一目標。正如我們今年早些時候提到的，我們增加了銷售團隊。我們已投資改善患者支援服務，並希望在 2026 年之前將該品牌推向歐洲市場。

Now we see the opportunity not only because we're investing in building capability but there's a significant unmet medical need when it comes to patients suffering from target dyskinesia. And tragically, there's a lot of patients who still need to benefit from AUSTEDO. So we have work to do there and ability to improve patients' lives.

現在我們看到了這個機會，不僅因為我們正在投資於能力建設，而且對於患有目標運動障礙的患者來說，還有一個重大的未滿足的醫療需求。可悲的是，有許多患者仍然需要從 AUSTEDO 中受益。因此，我們有工作要做，也有能力改善病人的生活。

Now moving on to the next slide AJOVY. We're on track to reach or even exceed the $400 million for 2023 with good growth in Q3 and revenues of $114 million. As I said, revenue -- as I said, growth was 22%. What I like about it, AJOVY is not the fact that we're just growing it in all of our regions, but we remain very competitive in what is a competitive sector and segment of the market, highlighting our sales and marketing and medical commercial capabilities.

現在轉到下一張投影片 AJOVY。隨著第三季的良好成長和 1.14 億美元的收入，我們預計在 2023 年達到甚至超過 4 億美元。正如我所說，收入增長了 22%。我喜歡 AJOVY 的一點並不是我們只是在所有地區都在發展它，而是我們在競爭激烈的行業和細分市場中仍然保持著非常強的競爭力，突出了我們的銷售和營銷以及醫療商業能力。

Now moving on to the next slide. The newest member of our innovative family is UZEDY, a long-acting treatment for risperidone launched in May of this year. Now we're pleased with the launch. And as you can see, UZEDY's capturing over 55% of all NBRx in the risperidone long-acting market. And this is driven by the strong feedback we are receiving from physicians and patients, physicians -- patients obviously, appreciate the subcutaneous injection versus intramuscular. I think the physicians find the fact that UZEDY can reach therapeutic doses within 6 to 24 hours to be really helpful when they are treating patients who have a relapse. This market is an attractive market. It's a $4 billion market. UZEDY will have a real part to play in that market.

現在轉到下一張投影片。我們創新家族的最新成員是 UZEDY，這是一種利培酮長效治療藥物，於今年 5 月推出。現在我們對發布感到滿意。正如您所看到的，UZEDY 佔據了利培酮長效市場中所有 NBRx 的 55% 以上。這是由我們從醫生和患者那裡收到的強烈回饋所推動的，顯然，與肌肉注射相比，醫生和患者更欣賞皮下注射。我認為醫生發現 UZEDY 可以在 6 至 24 小時內達到治療劑量，這在治療復發患者時非常有幫助。這個市場是一個有吸引力的市場。這是一個價值 40 億美元的市場。 UZEDY 將在該市場發揮真正的作用。

Now as I've said before, 2023 as a setup year for 2024, we need to make sure we get access for many inclusions in our hospitals, and we're making very good progress on that. So we look forward to updating you on UZEDY as we near the end of the year.

正如我之前所說，2023 年是 2024 年的基礎年，我們需要確保我們的醫院能夠獲得許多包容性的服務，並且我們在這方面正在取得非常好的進展。因此，我們期待在接近年底時向您通報 UZEDY 的最新情況。

Now moving away from our innovative portfolio to our generics business. And as I said earlier, I'm pleased to show that we're growing our generics business across all of our regions. U.S. included. And as you can see, strong growth in the U.S. 15%, a solid growth in Europe and good growth in emerging markets and local currencies of 17%.

現在從我們的創新產品組合轉向我們的仿製藥業務。正如我之前所說，我很高興向大家展示我們正在所有地區發展仿製藥業務。包括美國。正如您所看到的，美國強勁成長了 15%，歐洲穩健成長，新興市場和當地貨幣也實現了 17% 的良好成長。

Now to move on to our pipeline, which is obviously a key pillar of our strategy, our pivot to growth strategy and step up innovation. Just to look at the late-stage assets we have. I've talked about olanzapine and I've encouraged we are with the recruitment of our patients into that Phase III trial, and we look to be announcing what Eric and his team will look to be announcing those results in the second half of next year. Once again, to reiterate, this is a significant market. And with olanzapine, there really isn't a satisfactory long-acting version of this product, this molecule in the market. So we're excited about this and hope we can bring to this patient population.

現在轉向我們的產品線，這顯然是我們策略的關鍵支柱，也是我們成長策略和加強創新的關鍵。看看我們擁有的後期資產。我已經談到了奧氮平，我鼓勵我們正在招募患者參加 III 期試驗，我們希望宣布艾瑞克和他的團隊將在明年下半年宣布這些結果。再次重申，這是一個重要的市場。對於奧氮平，市場上確實沒有令人滿意的長效版本的該產品、該分子。因此，我們對此感到興奮，並希望能夠為這群患者帶來幫助。

Moving on to ICS/SABA, another product that entered Phase III clinical trials in Q3, we started to acute patients already. And this is a significant opportunity. As I mentioned on previous calls, based on the guidelines in the U.S., there are 10 million patients who should be on an ICS/SABA combination. And so if you just take 30% of these, the market is still significant at $2.5 billion. So a real opportunity to continue to drive growth for Teva in our innovative business.

接下來是 ICS/SABA，這是第三季進入 III 期臨床試驗的另一種產品，我們已經開始對急性患者進行治療。這是一個重要的機會。正如我在之前的電話會議中提到的，根據美國的指南，有 1000 萬名患者應該接受 ICS/SABA 聯合治療。因此，如果只考慮其中的 30%，這個市場仍然很大，價值 25 億美元。這是繼續推動 Teva 創新業務成長的真正機會。

And then finally, on anti-TL1A, I have spoken a bit about it, and I'm sure Eric will touch upon this as well. But just to highlight the size of the opportunity in UC and CD, which we see is around $28 billion for what we think we have a best-in-class product.

最後，關於抗 TL1A，我已經談過一些，我相信 Eric 也會談到這一點。但只是為了強調 UC 和 CD 領域的機會規模，我們認為我們擁有一流的產品，價值約 280 億美元。

And then my final slide, I'd just like to close out with our recent progress on our ESG strategy and initiatives. In Q3, we made good progress on executing our ESG strategy and we made good progress against some of our ESG targets. And I'm pleased to announce on behalf of the team to the company received some awards. We were winner of the Best Company for ESG Reporting in the health care sector. And also in 2023, Best Corporate Social Responsibility initiatives. So really highlighting the work and the progress we've made on our ESG strategy.

最後一張投影片，我想以我們最近在 ESG 策略和舉措方面取得的進展作為結束語。第三季度，我們在執行 ESG 策略方面取得了良好進展，並且在實現一些 ESG 目標方面取得了良好進展。我很高興地代表公司團隊宣布獲得了一些獎項。我們榮獲醫療保健產業 ESG 報告最佳公司獎。 2023 年，也將獲得最佳企業社會責任措施。因此，我們要專注於我們在 ESG 策略方面所做的工作和取得的進展。

Now with that, I would like to hand over to my colleague, Eric Hughes, who will walk you through some of our pipeline news.

現在，我想將時間交給我的同事 Eric Hughes，他將向您介紹我們的一些管道新聞。

Thank you, Richard. Turn to the next slide. So as Richard mentioned, we're excited by the increased sales of AUSTEDO, which is a testament to AUSTEDO's safety and efficacy. To build upon what we've already achieved with AUSTEDO, we want to make sure that the flexibility and the convenience of AUSTEDO is improved with our patients, and we're happy to present this data from our real-world studies called START. This study was a real-world study to look at how our 4-week titration pack is used. What we see in this study is that 78% of the subjects completed the study, 97% were adherent to the medication, 76% reached the optimal dose and 95% reached a dose greater than 24 milligrams per day.

謝謝你，理查。轉到下一張投影片。正如理查德所提到的，我們對 AUSTEDO 銷售的成長感到興奮，證明了 AUSTEDO 的安全性和有效性。為了在 AUSTEDO 已經取得的成果的基礎上，我們希望確保為患者提高 AUSTEDO 的靈活性和便利性，並且我們很高興提供來自名為 START 的現實世界研究的數據。這項研究是一項真實世界研究，旨在了解如何使用我們的 4 週滴定包。我們在這項研究中看到，78% 的受試者完成了研究，97% 的受試者堅持服藥，76% 的受試者達到了最佳劑量，95% 的受試者達到了每天超過24 毫克的劑量。

But why is this important? Well, the important thing is to get patients on the right dose that's optimal for them, use the flexibility of AUSTEDO and maintain patients effective treatment. And you can see that in this study, we had actually a very good response rate and the abnormal involuntary movement scale of about 4.8%, which is actually numerically better than our pivotal studies. So we believe with the titration pack the flexibility of the dosing and the adherence rates that we see in our START study, we will maximize the ability of patients to receive and obtain the proper dose and stay on treatment. Turn the next slide.

但這為什麼很重要？嗯，重要的是讓患者接受最適合他們的正確劑量，利用 AUSTEDO 的靈活性並維持患者有效的治療。你可以看到，在這項研究中，我們實際上有非常好的反應率，異常不自主運動比例約為 4.8%，這實際上在數值上比我們的關鍵研究要好。因此，我們相信，透過滴定包的劑量靈活性和我們在 START 研究中看到的依從率，我們將最大限度地提高患者接受和獲得適當劑量並繼續治療的能力。翻下一張投影片。

As Richard mentioned, we're also excited to see the improvement -- improved sales of AJOVY. AJOVY is a program that we have for migraine, and we can recapitulate our Phase III studies and its effect on the monthly migraine days that we improve. So in this study called UNITE. It was a prospective study, but the uniqueness of this study was that we looked at patients with migraine who also had depressive symptoms. And this is important because depression is a comorbidity with migraine that lead to chronic migraine increasing -- increased disabilities and decreases in quality of life.

正如理查德所提到的，我們也很高興看到 AJOVY 銷售的改善。 AJOVY 是我們對偏頭痛的一項計劃，我們可以概括一下我們的 III 期研究及其對我們改善的每月偏頭痛天數的影響。所以這項研究稱為「UNITE」。這是一項前瞻性研究，但這項研究的獨特之處在於我們觀察了同時患有憂鬱症狀的偏頭痛患者。這一點很重要，因為憂鬱症是偏頭痛的一種合併症，會導致慢性偏頭痛加重——殘疾增加和生活品質下降。

So we designed UNITE to prospectively look at both the effects on monthly migraine treatment and as well as depressive symptoms. And we're pleased to show that the primary endpoint was achieved and recapitulated our interim results and the monthly migraine rates, but also in the secondary end point on depressive symptoms. So this is the first study to show in fact, that we have a significant effect, not only on monthly migraine but also on depressive systems in a CGRP either subcutaneous or oral. So very excited to see this. I think this is a great benefit to patients. Go to the next slide.

因此，我們設計 UNITE 來前瞻性地研究每月偏頭痛治療和憂鬱症狀的影響。我們很高興地表明，主要終點已經實現，並概括了我們的中期結果和每月偏頭痛發生率，以及憂鬱症狀的次要終點。因此，這是第一項研究表明，我們不僅對每月偏頭痛有顯著效果，而且對皮下或口服 CGRP 的憂鬱系統也有顯著效果。看到這個非常興奮。我認為這對患者來說是一個很大的優點。轉到下一張投影片。

Now we're also excited to present more data on UZEDY from our pivotal studies in this sub analysis. In the RISE study or pivotal study, we looked at the disease duration across all the patients that we enrolled. And here, you can see that we had patients that were less than 5 years all the way up to greater than 20 years. And why is this sub-analysis important?

現在，我們也很高興在此子分析中提供來自我們關鍵研究的更多關於 UZEDY 的數據。在 RISE 研究或關鍵研究中，我們研究了所有入組患者的疾病持續時間。在這裡，您可以看到我們的患者年齡從 5 歲以下一直到 20 歲以上。為什麼這個子分析很重要？

Well, there is the thought that after many years -- greater than 20 years, the treatment of schizophrenia becomes slightly resistant to treatment. But here, we can see that clearly, there's no impact on disease duration on the effectiveness of UZEDY. So greater than 20 years is a very good, population has shown treatment effect then. Equally as important is those patients that are less than 5 years duration of their treatment. Here, again, even in this population, which has a higher relapse rate early in treatment, we also had a great effect, which is important because in LAI, there is a continuing theory that LAIs are an effective way of starting treatment. Thank you. Next slide, please.

嗯，有人認為，經過很多年——超過 20 年，精神分裂症的治療就會變得有些抗藥性。但在這裡，我們可以清楚地看到，病程長短對 UZEDY 的有效性沒有影響。所以大於20年是一個很好的時間，那時人群已經顯示出治療效果。同樣重要的是那些治療時間少於 5 年的患者。在這裡，再次強調，即使在這個治療早期復發率較高的人群中，我們也取得了很好的效果，這很重要，因為在LAI 中，有一個持續的理論認為LAI 是開始治療的有效方法。謝謝。請下一張投影片。

Now Richard mentioned the olanzapine LAI study. It's going very well. We've enrolled over 550 patients to date. And I just want to review quickly what the study design is for our Phase III program. We do have 3 doses against placebo for 8 weeks to the primary endpoint, and then we'll roll those subjects over into 3 doses again for an up to 48 weeks to build our safety database. This study has enrolled very quickly. And I'll go over time lines of the readout, but we're excited to see that a study enrolls quickly. This is obviously a testament to the capabilities of the R&D organization as well as the desire of investigators to use an injectable olanzapine. Go to the next slide.

現在理查德提到了奧氮平 LAI 研究。進展順利。迄今為止，我們已經招募了超過 550 名患者。我只想快速回顧一下我們第三階段專案的研究設計。我們確實在 8 週內注射了 3 劑安慰劑，以達到主要終點，然後我們將這些受試者再次分為 3 劑，持續長達 48 週，以建立我們的安全資料庫。這項研究的註冊速度非常快。我將詳細介紹讀出的時間線，但我們很高興看到一項研究很快就入組了。這顯然證明了研發組織的能力以及研究人員使用注射奧氮平的願望。轉到下一張投影片。

Finally, I just want to touch base on our TL1A program. Richard mentioned that we had a deal signed with Sanofi to advance this very important product forward. As I've mentioned many times in the past, this is a very important underserved market. There's over 4 million patients diagnosed. About 2.7 million are treated However, the treatments are -- have good effects that only lasts for so long, people frequently cycle through treatments. And many of these patients actually end up still getting surgery as their disease progresses. So more treatments are important in this disease area.

最後，我想談談我們的 TL1A 計劃。理查德提到，我們與賽諾菲簽署了一項協議，以推進這項非常重要的產品的發展。正如我過去多次提到的，這是一個非常重要但服務不足的市場。確診患者已超過 400 萬人。大約有 270 萬人接受了治療。然而，這些治療的良好效果只能持續很長時間，因此人們經常循環接受治療。隨著疾病的進展，許多患者實際上最終仍接受手術。因此，在這一疾病領域提供更多的治療方法非常重要。

We believe we have the best-in-class potential for TL1As, we have a potent compound with great selectivity. We've shown good safety in our asthma study, and we've shown low antidrug antibodies today. The collaboration with Sanofi is going to capitalize on the potential of this target. This target has the potential to go across many different disease indications. It's a pleiotropic cytokine that affects many different pathways. So the possibilities are large for this group. As I've mentioned, we're going to -- we've accelerated the program, and we're putting all our effort on getting our interim analysis readout in 2024. So looking forward to more in collaboration with Sanofi.

我們相信我們擁有同類最佳的 TL1As 潛力，我們擁有具有出色選擇性的強效化合物。我們在氣喘研究中顯示出良好的安全性，並且今天我們的抗藥物抗體水平較低。與賽諾菲的合作將充分利用這一目標的潛力。該目標有可能涵蓋許多不同的疾病適應症。它是一種多效性細胞因子，影響許多不同的途徑。所以這個群體的可能性很大。正如我所提到的，我們將加速該計劃，並盡一切努力在 2024 年獲得中期分析讀數。因此，期待與賽諾菲進行更多合作。

And just to review our milestones and development. So I mentioned TL1A, we're moving forward to putting resources and investment in making sure that we achieve our interim analysis within the second half of 2024. I have been talking about olanzapine LAI and its acceleration. We have been reporting that we were going to report the results of the first half of 2025. But I'm happy to say we've accelerated that to the second half of 2024. We've enrolled patients in our anti-IL15 POC study for celiac disease, and we will have PK from our SAD and MAD studies coming out in the second half of 2024. We are well on our path to have our first patient dosed in our anti-PD1-IL2 program in the first half of 2024 as when we submit our IND. And as Richard mentioned, ICS/SABA has now launched into our Phase III program, and we're looking for results in first half of -- or second half 2026. So lots of things going on. I'm glad to see that we're accelerating our programs and keeping to our time lines.

只是為了回顧我們的里程碑和發展。所以我提到了 TL1A，我們正在投入資源和投資，以確保我們在 2024 年下半年實現中期分析。我一直在談論奧氮平 LAI 及其加速。我們一直在報告，我們將在 2025 年上半年報告結果。但我很高興地說，我們已將其加快到 2024 年下半年。我們已將患者納入我們的抗 IL15 POC 研究對於乳糜瀉，我們的SAD 和MAD 研究的PK 將於2024 年下半年公佈。我們正在順利地在2024 年上半年讓我們的第一位患者在我們的抗PD1-IL2 項目中接受給藥就像我們提交 IND 時一樣。正如 Richard 所提到的，ICS/SABA 現在已啟動我們的第三階段計劃，我們正在尋找 2026 年上半年或下半年的結果。所以很多事情正在發生。我很高興看到我們正在加快我們的計劃並遵守我們的時間表。

And with that, I'm going to pass it off to Eli.

接下來，我要把它交給 Eli。

Thank you, Eric, and good morning and good afternoon to everyone. I'll begin my review of our Q3 2023 financial results with Slide 25. Starting with our GAAP performance. Revenues in the third quarter of 2023 were $3.9 billion, representing an increase of 7% compared to Q3 2022, both in reported terms and in local currency. To provide you some color on our revenue performance by region, in North America, we had overall strong performance with 11% growth in Q3 2023 compared to third quarter last year. This growth was mainly driven by higher revenue from generics products, AUSTEDO and AJOVY partially offset by lower revenue from BENDEKA and TREANDA.

謝謝你，艾瑞克，祝大家早安，下午好。我將從幻燈片 25 開始回顧我們 2023 年第三季的財務業績。從我們的 GAAP 表現開始。 2023 年第三季的營收為 39 億美元，較 2022 年第三季成長 7%，無論是按報告金額還是以當地貨幣計算。為了讓您了解我們按地區劃分的營收表現，在北美，我們的整體表現強勁，與去年第三季相比，2023 年第三季成長了 11%。這一增長主要是由於仿製藥產品、AUSTEDO 和 AJOVY 收入的增加而部分被 BENDEKA 和 TREANDA 收入的減少所抵消。

As Richard mentioned, revenue in our generics business in North America increased by 15% and in Q3 2023 mainly due to revenues from generics Revlimid, partially offset by increased competition to other generic products. Revenues in our Europe segment were flat in local currency terms. We continue to see strong growth in AJOVY and a solid growth in our generics business in the third quarter. This was, however, largely offset by lower revenues from our legacy brands, including COPAXONE. Revenues from our International Markets segment increased by 20% in local currency terms. This was mainly driven by higher revenue from our generics product, largely coming from price increases as measured to offset higher costs due to inflationary pressures. This increase was partially offset by regulatory price reduction and generic competition to off-patent products in Japan.

正如理查德所提到的，我們在北美的仿製藥業務的收入在 2023 年第三季度增長了 15%，主要是由於仿製藥 Revlimid 的收入，部分被其他仿製藥產品競爭加劇所抵消。以當地貨幣計算，我們歐洲部門的收入持平。我們繼續看到 AJOVY 的強勁成長和我們的仿製藥業務在第三季的穩健成長。然而，這在很大程度上被包括 COPAXONE 在內的傳統品牌收入下降所抵消。以當地貨幣計算，我們國際市場部門的收入成長了 20%。這主要是由於我們的仿製藥產品收入增加，主要來自價格上漲，以抵消通膨壓力導致的成本上漲。這一增長被日本監管價格下降和專利到期產品的仿製藥競爭所部分抵消。

GAAP operating income was $365 (sic) [$355] million in the third quarter of 2023 compared to an operating income of $419 million in the third quarter of 2022. The lower operating income in the third quarter of 2023 was mainly due to higher legal settlements and loss contingencies, higher R&D and S&M expenses, partially offset by higher gross profit. Our higher R&D expenses in the third quarter of 2023 compared to the third quarter of 2022 were mainly due to an increase to support our late-stage innovation pipeline that Richard and Eric mentioned earlier, in line with our pivot to growth strategy. In addition, last year and the third quarter of 2022, our R&D expenses were lower due to an adjustment in payments related to a contract with one of our R&D partners. We also saw an increase in our S&M expenses compared to the third quarter last year mainly due to promotional activities related to AUSTEDO and UZEDY as well as exchange rate fluctuations in our Europe segment, where the GAAP income of $80 million compared to the net income of $56 million in Q3 2022 and a GAAP earnings per share of $0.07 compared to GAAP earnings per share of $0.05 in the same period a year ago.

2023 年第三季的GAAP 營業收入為365（原文如此）[3.55 美元]百萬美元，而2022 年第三季的營業收入為4.19 億美元。2023 年第三季營業收入較低的主要原因是法律和解金額增加和或有損失、較高的研發和行銷費用，但被較高的毛利部分抵銷。與 2022 年第三季相比，我們 2023 年第三季的研發費用較高，主要是由於理查德和艾瑞克之前提到的支持我們後期創新管道的增加，這符合我們的成長策略。此外，去年和 2022 年第三季度，由於與我們的一個研發合作夥伴簽訂的合約相關的付款調整，我們的研發費用較低。與去年第三季相比，我們的S&M 費用也有所增加，這主要是由於與AUSTEDO 和UZEDY 相關的促銷活動以及我們歐洲部門的匯率波動，其中GAAP 收入為8000 萬美元，而淨利潤為8000 萬美元。2022 年第三季的營收為 5,600 萬美元，GAAP 每股收益為 0.07 美元，而去年同期的 GAAP 每股收益為 0.05 美元。

The higher net income in the third quarter of 2023 was mainly due to reduced tax expenses in 2023 compared to Q3 2022. Our tax rate in Q3 2023 was mainly affected by increased deferred tax assets resulting [IT-related] integration plans. Such integration plans have been adopted, among others, in an effort of addressing the global adoption of OECD pillar to minimum effective corporate tax commencing in 2024. The increase in our net income was partially offset by lower operating income as discussed above.

2023 年第三季淨利較高，主要是由於2023 年稅費支出較2022 年第三季減少。我們2023 年第三季的稅率主要受到[IT 相關]整合計畫導致的遞延稅資產增加的影響。除此之外，已採用此類整合計劃，以解決從 2024 年開始全球採用經合組織支柱的最低有效企業稅問題。如上所述，我們淨利潤的成長部分被營業收入下降所抵消。

Foreign exchange rate movements during the third quarter of 2023, net of hedging effects negatively impacted our revenues and GAAP operating income by $9 million and [$53] million, respectively, compared to the third quarter of 2022. This was primarily a result of the impact of a stronger U.S. dollar against currencies of certain international markets in which we operate, partially offset by the benefit from euro appreciation, approximately 46% of our revenue in Q3 2023 came from sales denominated in non-U.S. dollar currency.

與 2022 年第三季相比，2023 年第三季的外匯匯率變動（扣除對沖影響）對我們的收入和 GAAP 營業收入分別產生了 900 萬美元和 5,300 萬美元的負面影響。這主要是由於由於美元兌我們經營所在的某些國際市場的貨幣走強，部分被歐元升值的好處所抵消，我們2023 年第三季約46% 的收入來自以非美元貨幣計價的銷售。

Turning to Slide 26. You can see that the total non-GAAP adjustment in the third quarter of 2023 were approximately $598 million compared to $602 million in Q3 2022. Notable GAAP adjustment this quarter include legal settlements, loss contingencies of $314 million, mainly related to estimated provision recorded in connection with certain litigation cases in U.S. Additional notable adjustments included amortization of purchased intangible assets of $145 million, the majority of which is included in cost of sales.

轉向投影片26。您可以看到，2023 年第三季的非GAAP 調整總額約為5.98 億美元，而2022 年第三季為6.02 億美元。本季值得注意的GAAP 調整包括法律和解、或有損失3.14 億美元，主要與與美國某些訴訟案件相關的估計準備金。其他顯著調整包括購買無形資產 1.45 億美元的攤銷，其中大部分包含在銷售成本中。

Now moving to Slide 27 for review of our non-GAAP performance. As I mentioned, our third quarter revenue were totaled approximately $3.9 billion represented growth of 7% compared to the third quarter of 2022.

現在轉到幻燈片 27，回顧我們的非 GAAP 業績。正如我所提到的，我們第三季的營收總計約為 39 億美元，與 2022 年第三季相比成長了 7%。

Now let's move down to the P&L, starting with the gross profit margin. Our non-GAAP gross profit margin was 53.5% in the third quarter of 2023 compared to 53% in Q3 2022. This improvement in non-GAAP gross profit margin was mainly driven by a favorable mix of products, including higher revenue from AUSTEDO in our North America segment partially offset by higher costs due to inflationary and other macroeconomic pressures.

現在讓我們先從毛利率開始討論損益表。我們的非 GAAP 毛利率在 2023 年第三季為 53.5%，而 2022 年第三季為 53%。非 GAAP 毛利率的改善主要得益於有利的產品組合，包括我們的 AUSTEDO 收入增加北美業務部分被通膨和其他宏觀經濟壓力導致的成本上升所抵銷。

As I mentioned last quarter and as expected, this was an approximate 130 basis point sequential improvement in our non-GAAP gross profit margin in Q3 2023 compared to the second quarter of 2023. This sequential improvement in gross margin was driven by continued shift towards a more normalized portfolio mix, mainly driven by strong growth in AUSTEDO, continued growth in AJOVY as well as improvement in our cost of goods sold due to the expected easing of the inflationary pressures and other measures we are taking to drive productivity in our supply chain.

正如我上季度提到的，正如預期的那樣，與 2023 年第二季度相比，我們 2023 年第三季度的非 GAAP 毛利率環比提高了約 130 個基點。毛利率的環比改善是由持續轉向更正常化的投資組合，主要是由於AUSTEDO 的強勁增長、AJOVY 的持續增長以及由於通膨壓力預期緩解以及我們為提高供應鏈生產力而採取的其他措施而導致的銷售成本改善。

Our non-GAAP operating margin in Q3 2023 was 26.5% versus 27.2% in Q3 2022. This decrease in operating margin was mainly due to an increase in R&D expenses, partially offset by higher gross profit margins, as I just mentioned, as well as lower G&A expenses. We ended the third quarter with a non-GAAP earnings per share of $0.60 compared to $0.59 in Q3 2022, mainly due to a higher non-GAAP operating income, partially offset by higher financial expenses in Q3 2023.

我們2023 年第三季的非GAAP 營業利潤率為26.5%，而2022 年第三季為27.2%。營業利潤率的下降主要是由於研發費用的增加，部分被更高的毛利率所抵消，正如我剛才提到的，以及降低一般行政費用。截至第三季末，我們的非 GAAP 每股盈餘為 0.60 美元，而 2022 年第三季為 0.59 美元，這主要是由於非 GAAP 營業收入增加，部分被 2023 年第三季財務費用增加所抵銷。

Now let's take a look at our spend base on Slide 28. As you can see, our quarterly spend base increased by $213 million or $171 million on a local currency basis. This increase was due to a higher cost of goods sold related to a higher revenue compared to the third quarter of 2022, as well as higher operating expenses related to higher R&D and S&M that I just mentioned earlier, partially offset by efficiencies in our G&A expenses.

現在讓我們來看看投影片 28 上的支出基礎。如您所見，我們的季度支出基礎增加了 2.13 億美元，以當地貨幣計算增加了 1.71 億美元。這一增長是由於與2022 年第三季相比，與收入增加相關的銷售商品成本增加，以及我之前提到的與研發和行銷管理費用增加相關的營運費用增加，部分被我們的G&A 費用效率所抵消。

As we move forward, we expect our operating expenses to be approximately from $1 billion to $1.05 billion in the fourth quarter including a quarterly run rate of R&D expenses to be in the range of $230 million to $250 million as we continue to progress our [pipeline], including the late-stage incubated assets. This is in line with our pivot-to-growth strategy to position the business for long-term growth and success.

隨著我們的前進，我們預計第四季度的營運費用約為10 億美元至10.5 億美元，其中隨著我們繼續推進我們的管道，研發費用的季度運行率將在2.3 億美元至2.5 億美元之間]，包括後期孵化資產。這符合我們以成長為中心的策略，使業務能夠實現長期成長和成功。

Turning to free cash flow on Slide 29. In the first 3 quarters of 2023, we generated $0.9 billion of free cash flow versus $1.1 billion during the same period last year, a decrease of $200 million. This resulted mainly from changes in working capital items, including on average, higher inventory levels as well as lower net income as a result of lower gross profit and higher operating and finance expenses. Today, we are reaffirming our 2023 free cash flow guidance. Our 2023 free cash flow is expected to be in the range of $1.7 billion to $2.1 billion, our fourth quarter free cash flow expectation includes a sequential ramp-up in our revenue and profitability with a meaningful contribution from AUSTEDO. In addition, we continue to drive working capital improvements, including significant inventory efficiencies and continuation of the positive impact from accounts payable as a result of expansion in our vendor payment program, which we launched earlier this year. This free cash flow outlook range does not include the first upfront milestone payments stable to us under the exclusive collaboration with Sanofi for our anti-TL1A, which we announced in October.

轉向幻燈片 29 上的自由現金流。2023 年前 3 季度，我們產生了 9 億美元的自由現金流，而去年同期為 11 億美元，減少了 2 億美元。這主要是由於營運資本項目的變化造成的，包括平均庫存水準上升以及毛利潤下降和營運和財務費用上升導致淨利潤下降。今天，我們重申 2023 年自由現金流指引。我們 2023 年的自由現金流預計在 17 億美元至 21 億美元之間，我們第四季度的自由現金流預期包括我們的收入和盈利能力的連續增長，其中 AUSTEDO 做出了重大貢獻。此外，我們繼續推動營運資本的改善，包括顯著的庫存效率以及由於今年早些時候推出的供應商付款計劃的擴展而持續產生的應付帳款的積極影響。這項自由現金流前景範圍不包括我們在 10 月宣布的與賽諾菲針對我們的抗 TL1A 藥物的獨家合作下穩定的第一筆預付款里程碑付款。

Turning to Slide 30. Our net debt at the end of Q3 2023 was $17.7 billion compared to $18.4 billion at the end of 2022. Our gross debt was $20 billion compared to $21.2 billion at the end of 2022. The decrease in our gross debt was mainly due to $1.6 billion senior notes repaid at maturity and [$54] million of exchange rate fluctuations partially offset by $500 million outstanding under the revolving credit facility as of September 30, 2023.

轉向幻燈片30。2023 年第三季末我們的淨債務為177 億美元，而2022 年底為184 億美元。我們的總債務為200 億美元，而2022 年底為212 億美元。我們的總債務減少了主要是由於到期時償還的 16 億美元優先票據以及[54]百萬美元的匯率波動被截至 2023 年 9 月 30 日循環信貸安排下未償還的 5 億美元部分抵消。

As I mentioned last quarter, in July 2023, we withdraw a total amount of $700 million under our $1.8 billion revolving credit facility. The proceeds of which were used to repay $1 billion of our senior notes at maturity in July. In September 2023, we repaid $200 million. And as of today, $500 million is outstanding under the revolver credit facility.

正如我在上個季度提到的，即 2023 年 7 月，我們在 18 億美元的循環信貸額度下提取了總計 7 億美元的資金。所得款項用於償還 7 月到期的 10 億美元優先票據。 2023 年 9 月，我們償還了 2 億美元。截至目前，循環信貸額度下尚未償還 5 億美元。

Our net debt to EBITDA improved compared to Q2 2023, coming now at 4.03x for Q3 2023 due to foreign exchange rate movements as well as free cash flow generation in the third quarter. As part of our capital allocation strategy, debt reduction continues to be our focus, and we expect to continue to work towards our long-term financial target of being 2x net debt-to-EBITDA by end of 2027.

由於匯率變動以及第三季自由現金流的產生，我們的 EBITDA 淨債務比 2023 年第二季有所改善，2023 年第三季的淨債務為 4.03 倍。作為我們資本配置策略的一部分，減少債務仍然是我們的重點，我們預計將繼續努力實現到 2027 年底淨債務與 EBITDA 達到 2 倍的長期財務目標。

Turning to Slide 31, which presents our upcoming debt maturities. As I mentioned, we have already repaid [$1 billion] of our 2.8% senior notes at maturity in July 2023. So there are currently no additional maturity payments due in 2023. Following our successful refinancing of approximately $2.5 billion of our debt through a sustainability linked senior notes during the first quarter of 2023, we've aligned our near-term debt maturities with our annual free cash flow guidance for this year. We believe we are well positioned to continue to serve our debt and meet these upcoming maturities over the next couple of years with our ongoing cash flow generation.

轉向幻燈片 31，其中介紹了我們即將到期的債務。正如我所提到的，我們已經在2023 年7 月到期時償還了[10 億美元] 2.8% 的優先票據。因此，目前沒有2023 年到期的額外到期付款。在我們透過永續發展計劃在成功為約25 億美元的債務進行再融資之後，在 2023 年第一季關聯優先票據後，我們已將近期債務到期日與今年的年度自由現金流指引保持一致。我們相信，我們有能力繼續償還債務，並透過持續產生現金流來滿足未來幾年即將到期的債務。

Now turning to our 2023 non-GAAP outlook on Slide 32. As Richard highlighted earlier, we have a solid third quarter and year-to-date performance in terms of our revenues across all regions. This includes continued strong momentum in our key growth engines, especially AUSTEDO continued growth in a AJOVY as well as solid performance in our core generics business globally. In addition, we are seeing a relatively higher revenue from COPAXONE compared to our initial expectation, which we now expect it to be approximately $550 million for the full year. To reflect this revenue performance in the first 9 months, along with the expected development in the fourth quarter, we are increasing our full year revenue guidance range by $100 million, we're now expected our revenue to be between $15.1 billion to $15.5 billion for and the full year of 2023. We also continue to expect sequential improvement in our margins in the fourth quarter. As previously communicated, we are driving and continued the shift in our portfolio mix, mainly driven by strong growth in AUSTEDO as well as further improvement in our cost of goods sold.

現在轉向幻燈片 32 上的 2023 年非 GAAP 展望。正如理查德之前強調的那樣，就所有地區的收入而言，我們第三季和年初至今的業績表現強勁。這包括我們關鍵成長引擎的持續強勁勢頭，特別是 AJOVY 中 AUSTEDO 的持續成長，以及我們全球核心仿製藥業務的穩健表現。此外，與我們最初的預期相比，我們看到 COPAXONE 的收入相對較高，目前我們預計全年收入約為 5.5 億美元。為了反映前 9 個月的營收表現以及第四季的預期發展，我們將全年營收指引提高了 1 億美元，目前預計我們的營收將在 151 億美元至 155 億美元之間以及2023 年全年。我們也繼續預計第四季的利潤率將持續改善。正如之前所傳達的，我們正在推動並繼續我們的投資組合的轉變，這主要是由於 AUSTEDO 的強勁增長以及我們的銷售成本的進一步改善所推動的。

To reflect our year-to-date tax performance that I referred earlier, we are now expecting our annual non-GAAP tax rate for the full year 2023 to be in the range of 12% to 15%. And we expect our fully diluted share count to be approximately 1.132 million shares for the full year of 2023. Today, we are also reaffirming our 23% non-GAAP outlook for operating income, EBITDA, earnings per share and free cash flow as provided in February.

為了反映我之前提到的我們年初至今的稅務表現，我們現在預計 2023 年全年的非 GAAP 年度稅率將在 12% 至 15% 之間。我們預計 2023 年全年的完全攤薄後股票數量約為 1,132,000 股。今天，我們也重申我們對營業收入、EBITDA、每股盈餘和自由現金流的 23% 非 GAAP 展望，如二月。

I want to reiterate that our full year revenue, operating income, adjusted EBITDA, diluted EPS and free cash flow outlook ranges do not include the first upfront milestone payment payable to us under the exclusive collaboration with Sanofi for our anti-TL1A, which we announced in October.

我想重申，我們的全年收入、營業收入、調整後EBITDA、稀釋每股收益和自由現金流前景範圍不包括我們宣布的與賽諾菲獨家合作的抗TL1A 藥物應付的第一筆預付款里程碑付款在十月。

With that, this concludes my review of Teva results for the third quarter of 2023. And now I will hand it back to Richard for a summary.

至此，我對 Teva 2023 年第三季業績的回顧就結束了。現在我將其交還給理查德進行總結。

Thank you, Eli, and thank you, Eric. So in summary, strong Q3 performance driven by AUSTEDO, the launch of UZEDY and AJOVY and good performance across our generics business in all 3 regions. To that, as you heard from Eli, we're increasing our guidance on revenues for this year. And I'm pleased to show that the pivot to growth strategy is starting to get traction. As I've highlighted with the AUSTEDO, the collaboration TL1A, with the capability build that Eric and his team have done has allowed us to accelerate olanzapine or long-acting product in Phase III studies as well as the Teva api recruitment of our CEO.

謝謝你，伊萊，謝謝你，艾瑞克。總而言之，AUSTEDO、UZEDY 和 AJOVY 的推出以及我們在所有 3 個地區的仿製藥業務的良好表現推動了第三季度的強勁業績。為此，正如您從 Eli 那裡聽到的那樣，我們正在提高今年的收入指導。我很高興地表明，轉向成長策略正開始受到關注。正如我與 AUSTEDO 所強調的那樣，TL1A 的合作以及 Eric 和他的團隊所做的能力建設使我們能夠加快奧氮平或長效產品的 III 期研究以及我們首席執行官的 Teva api 招聘。

With that, I'll hand it over to people to ask questions.

這樣，我就把它交給人們提問。

(Operator Instructions) Our first question for today comes from Umer Raffat of Evercore ISI.

（操作員說明）我們今天的第一個問題來自 Evercore ISI 的 Umer Raffat。

I noticed a dose level C was dropped in your TL1A trial. I'm assuming that was the highest dose. So I have a 2-part question. One, can you confirm that among the dose level A and B that was kept, you have at least a 500-milligram dose in there? And secondly, I understand that the decision to drop the dose level C was informed by optimizing evolving biomarker data. Could you please elaborate on that as well?

我注意到你們的 TL1A 試驗中降低了 C 劑量水平。我假設那是最高劑量。所以我有一個由兩個部分組成的問題。一，你能確認一下你所保存的劑量等級A和B中，至少有500毫克的劑量嗎？其次，我了解到降低劑量水平 C 的決定是透過優化不斷變化的生物標記數據得出的。能否也詳細說明一下？

Thanks for the call. Thanks for the question. Eric, I'll hand over to you.

感謝您的來電。謝謝你的提問。艾瑞克，我把任務交給你了。

Thank you, Umer. So yes, we amended our studies design, and we dropped the dose. This was driven largely impacted by our comparative in vitro data. As I mentioned, the potency of the compound is, we believe, is best in class. We think the selectivity drives a lot of our potential biomarker movement. We were looking at 3 TL1A levels, which I think are important in dose selection. And we use this in combination with RPK and what we've observed in other development programs when we look at exposures and the programs. So we took advantage of this, and we optimized the study by dropping a dose and increasing actually the size slightly in the other arms. So we're happy with the changes. I think that makes the program more efficient, more useful data that will come out of it. And I can't comment on dosing or which dose was removed at this time.

謝謝你，烏梅爾。所以，是的，我們修改了研究設計，並降低了劑量。這在很大程度上受到我們的體外比較數據的影響。正如我所提到的，我們相信該化合物的效力是同類中最好的。我們認為選擇性推動了我們許多潛在的生物標誌物的運動。我們正在研究 3 個 TL1A 水平，我認為這對於劑量選擇很重要。我們將其與 RPK 以及我們在查看曝光和專案時在其他開發專案中觀察到的情況結合使用。因此，我們利用了這一點，透過減少劑量並稍微增加其他臂的大小來優化研究。所以我們對這些改變感到滿意。我認為這使得程式更有效率，從中產生更有用的數據。我無法評論劑量或目前取消的劑量。

Our next question comes from Balaji Prasad from Specialty Pharma Equity Research.

我們的下一個問題來自 Specialty Pharma Equity Research 的 Balaji Prasad。

This is Balaji from Barclays. A couple of questions from me. Richard, just want to get your sense if you think that Teva has reached a spot where you're comfortable or actively seeking to expand your pipeline of portfolio either with BD or in-licensing? Secondly, on the guidance, I still see a $400 million spread so late into the year, which is rather interesting. Is it fair to assume that you are still expecting some large one-offs so late in the year that can still impact to the extent of a few hundred million dollars if approved?

我是巴克萊銀行的巴拉吉。我有幾個問題。 Richard，我只是想了解一下您是否認為 Teva 已達到您滿意的水平或正在積極尋求透過 BD 或引進許可來擴展您的產品組合管道？其次，就指導意見而言，今年這麼晚我仍然看到 4 億美元的價差，這相當有趣。是否可以公平地假設，您仍然預計今年這麼晚會出現一些大型一次性事件，如果獲得批准，仍可能產生數億美元的影響？

Thanks, Balaji. Thanks for the call and the question. I appreciate that. So on the BD to answer that question, yes, we are actively looking to do BD and in-license when we started that. We've been doing that actively. I think we are excited by the products we have in innovation within the market and in our pipeline. That said, as we committed in the pivot to growth, we want to build on that. We think we have capacity to add products, both in our pipeline and also commercially. So we are actively doing that. But we want to be very selective to make sure it fits to our portfolio, our TA strategy. So that does take some time.

謝謝，巴拉吉。感謝您的來電和提問。我很感激。因此，關於 BD 來回答這個問題，是的，當我們開始時，我們正在積極尋求進行 BD 和許可。我們一直在積極地這樣做。我認為我們對市場和管道中的創新產品感到興奮。也就是說，當我們致力於轉向成長時，我們希望在此基礎上再接再厲。我們認為我們有能力在管道中和商業上添加產品。所以我們正在積極地這樣做。但我們希望精挑細選，以確保它適合我們的投資組合和技術援助策略。所以這確實需要一些時間。

With regard to the guidance, I think your question was the $15.1 billion to $15.5 billion a bit of a range there. Do we expect a one-off to drive that. I'll let Eli answer that. So over to you, Eli.

關於指導，我認為你的問題是 151 億至 155 億美元的範圍有點大。我們是否期望一次性推動這項目標？我會讓伊萊回答這個問題。現在就交給你了，伊萊。

Yes. Thanks, Balaji, for the call -- for the question, sorry. And basically, we are actually keeping the guidance for AUSTEDO so you can actually look on the first 3 quarters and understand the growth there year-over-year Q4 just on AUSTEDO. But namely in terms of the other elements and underlying on the revenue, there is nothing there in specific that going to be changed versus current trends and considering the seasonality of Q4 that we have each year.

是的。謝謝巴拉吉打電話——抱歉問這個問題。基本上，我們實際上保留了 AUSTEDO 的指導，因此您實際上可以查看前三個季度並了解 AUSTEDO 上第四季度的同比增長情況。但也就是說，就其他要素和收入基礎而言，與當前趨勢相比，並考慮到我們每年第四季度的季節性，沒有任何具體的變化。

Our next question comes from Jason Gerberry of Bank of America.

我們的下一個問題來自美國銀行的 Jason Gerberry。

I guess, firstly, just on the TL1A partnership, I actually had a follow-up question regarding the $600 million milestone for starting Phase III. Is that contingent just on showing something stat fig as a benefit? Or do you actually need to generate data that are competitive with the more advanced TL1A programs? Just wondering how much risk there is to kind of capturing that $600 million milestone and moving forward?

我想，首先，就 TL1A 合作而言，我實際上有一個關於啟動第三階段的 6 億美元里程碑的後續問題。這是否僅取決於顯示一些統計數字作為好處？或者您實際上需要產生與更高級的 TL1A 程式競爭的資料嗎？只是想知道要實現 6 億美元的里程碑並繼續前進會有多大風險？

And then my second question, just on your EBITDA guide for the year. I guess, to get to the midpoint or the high end of the range, it's a pretty substantial sequential step-up. I get that there's going to be more brand revenue, better mix, better margin in the fourth quarter, but you presumably won't have the generic Revlimid contribution. So how should we think about OpEx swings here in fourth quarter versus sort of the run rate in the 3 quarters leading into 4Q? Like would we expect a step down in OpEx? Or is there some other factor that can drive this big sequential uptick?

然後是我的第二個問題，關於你們今年的 EBITDA 指南。我想，要達到該範圍的中點或高端，這是一個相當大的連續提升。我知道第四季將會有更多的品牌收入、更好的產品組合、更好的利潤率，但你可能不會得到通用的來那度胺 (Revlimid) 的貢獻。那麼，我們該如何看待第四季的營運支出波動與第四季前三個季度的運作率呢？就像我們預計營運支出會下降一樣嗎？或者有其他因素可以推動這種大幅連續上漲嗎？

Okay, Jason, thanks for the question. I'll start answering then I'll let my colleagues contribute. So on the TL1A, the Phase III. There were no conditions around the Phase III. The Phase III is about completing the Phase II and have the FDA approval to move into -- sorry, Phase II -- complete the Phase II and FDA approval to move into the Phase III. So that's what the deal is on. There's no criteria around that. So I think hopefully, that's very clear.

好的，傑森，謝謝你的提問。我將開始回答，然後讓我的同事做出貢獻。所以在 TL1A 上，第三階段。第三期週邊沒有任何條件。第三階段是關於完成第二階段並獲得 FDA 批准進入 - 對不起，第二階段 - 完成第二階段並獲得 FDA 批准進入第三階段。這就是交易的內容。對此沒有任何標準。所以我希望這是非常清楚的。

With regard to the EBITDA, the range I think it was and a bit about OpEx. So maybe I'll start this and then Eli can contribute. So you have seen that Eli talk about our OpEx going up, but this is in line with our strategy. This is in line with what we plan to execute. We're driving AUSTEDO, making sure that brand is supported appropriately the same for UZEDY, the product we just launched for schizophrenia. And obviously, Eric and his team have started to hit the ground running particularly on olanzapine and also TL1A recruiting faster than we expected. So it obviously incurs costs, but I think that's a good thing, particularly that's part of our pivot to growth strategy. So those are the reasons why the OpEx is probably has gone up. There is the reason why it's gone up, but we're pleased with them because it's in line with what we want to do.

關於 EBITDA，我認為是一個範圍，並且與營運支出有關。所以也許我會開始這個，然後 Eli 可以做出貢獻。所以你已經看到 Eli 談論我們的營運支出上升，但這符合我們的策略。這與我們計劃執行的一致。我們正在推動 AUSTEDO，確保品牌得到適當的支持，就像我們剛推出的治療精神分裂症的產品 UZEDY 一樣。顯然，Eric 和他的團隊已經開始著手工作，特別是在奧氮平和 TL1A 招募方面，速度比我們預期的要快。因此，這顯然會產生成本，但我認為這是一件好事，特別是這是我們轉向成長策略的一部分。這些就是營運支出可能上升的原因。上漲是有原因的，但我們對他們感到滿意，因為這符合我們想做的事情。

Now obviously, going forward, just to give a bit of flavor for the OpEx on the R&D, obviously, TL1A in partnership with Sanofi will have a 50% of that cost taken by Sanofi. So as we move into next year and possibly depending on where it closes this year, we'll have a contribution from Sanofi. So I think that -- we've thought about that. That allows us to manage our pipeline and to be very thoughtful but also think big about what we want to do at TL1A, now we have this collaboration.

現在顯然，展望未來，只是為了為研發方面的營運支出增添一些風味，顯然，與賽諾菲合作的 TL1A 將承擔賽諾菲承擔的 50% 的成本。因此，當我們進入明年時，可能取決於今年的結束時間，我們將得到賽諾菲的貢獻。所以我認為——我們已經考慮過這一點。這使我們能夠管理我們的管道，並深思熟慮，同時也思考我們想在 TL1A 做什麼，現在我們有了這種合作。

So -- and then the final part I'll say is, as we've commented before, Revlimid was possibility in Q3. We see that as a significantly less contributor in Q4, very small part of that. And so you take that into account.

所以，我要說的最後一部分是，正如我們之前評論的那樣，來那度胺 (Revlimid) 在第三季度是可能的。我們認為第四季的貢獻明顯減少，只是其中很小的一部分。所以你要考慮到這一點。

But Eli, maybe you'd like to add a bit more flavor to that as well?

但 Eli，也許你也想為此添加更多風味？

Yes. So thanks, Jason. So overall, the way we need to think about it, we will end up according to the guidance with higher revenue versus last year, but we will trend the OpEx at the level of close to 26% of our revenue. And that's the way to think about it. Another point for you to consider, we're still looking for probably [53%] gross margin for the year-end, which means there is a step up in Q4, which is mostly related to a favorable mix that we will have in that quarter, and that will drive our ability to sustain the EBITDA guidance, although obviously still increasing in terms of dollars.

是的。謝謝，傑森。因此，總體而言，我們需要考慮的方式是，根據指導，我們最終將獲得比去年更高的收入，但我們的營運支出趨勢將接近我們收入的 26%。這就是思考這個問題的方式。您需要考慮的另一點是，我們仍在尋找年底的毛利率可能為 [53%]，這意味著第四季度會有一個台階，這主要與我們將在該領域擁有的有利組合有關季度，這將推動我們維持EBITDA 指引的能力，儘管以美元計算顯然仍在成長。

Our next question comes from Nathan Rich of Goldman Sachs.

我們的下一個問題來自高盛的內森·里奇。

You mentioned the higher R&D expense in the quarter. I think you kind of expect maybe a bit of a step down in the fourth quarter. But I guess, going forward, what's the right way to think about R&D expense as a percent of sales just given the investments you're kind of making in the pipeline, does that move up a bit over time?

您提到本季研發費用較高。我認為你預計第四季可能會有所下降。但我想，展望未來，考慮到您在管道中進行的投資，將研發費用視為銷售額百分比的正確方法是什麼，隨著時間的推移，這一比例是否會上升？

And then on UZEDY, you mentioned the positive feedback from providers. I was wondering if you could just elaborate a little bit on that and how that's kind of informed your view on the pace of uptake and what -- how we should be thinking about the revenue contribution from this product as we go into next year?

然後在 UZEDY 上，您提到了提供者的正面回饋。我想知道您是否可以詳細說明這一點，以及這如何影響您對採用速度的看法，以及當我們進入明年時，我們應該如何考慮該產品的收入貢獻？

Thanks for the question, Nathan. So just -- and I'll hand to Eli -- just to sort of comment on the R&D expense. No, we don't expect a step down in Q4 because this is part of our strategy. And the strategy is to aggressively move our innovative pipeline through the clinic. And as I said, we have ICS/SABA into Phase III. We have olanzapine at full tilt in Phase III and obviously TL1A in Phase II, which we're moving very aggressively. So I think that's on purpose, and that will continue. I'll let Eli talk a bit about where we will be in percentage of sales. But obviously, one thing to always consider, which may be slightly new with Teva is, our sales, we have shown that we've grown ourselves for the second quarter in a row and we are moving the business back to growth. And so obviously, that does allow us some flexibility. Although I want to assure you our focus on expenses is maniacal. So that's just a thing worth and understanding.

謝謝你的提問，內森。因此，我將交給 Eli 來對研發費用發表一些評論。不，我們預計第四季不會出現下滑，因為這是我們策略的一部分。我們的策略是積極將我們的創新管道推向臨床。正如我所說，我們已將 ICS/SABA 納入第三階段。我們在第三階段全力推進奧氮平，顯然在第二階段我們正在積極推進 TL1A。所以我認為這是故意的，而且這種情況將會持續下去。我會讓 Eli 談談我們的銷售百分比。但顯然，需要始終考慮的一件事（對 Teva 來說可能有點新鮮）是我們的銷售，我們已經表明我們在第二季度連續成長，並且我們正在使業務恢復成長。顯然，這確實給了我們一定的靈活性。儘管我想向您保證，我們對開支的關注是瘋狂的。所以這只是一件值得理解的事。

But Eli, do you want to give a bit more flavor?

但伊萊，你想要多一點味道嗎？

Yes. So overall, the way to think about R&D, we're actually looking to trend just a bit above 6% for the year-end, which means that Q4 will also have a step up. And as I mentioned in my prepared remarks, we actually providing kind of more transparency here between [$230 million to $250] million and that will be by itself very close to, I would say, to the 6% that we see in the quarter and for the year. The way to think about it as we go forward, of course, we will provide our guidance for '24 on the back of Q4 on February. But the way to think about it, it will be a range between 6% to 6.5% of our revenue going forward according to our strategy. And this is mostly related to the mix inside the innovative feet in the R&D.

是的。因此，總的來說，從研發角度來看，我們實際上希望年底的成長率略高於 6%，這意味著第四季也將有所提升。正如我在準備好的發言中提到的，我們實際上在這裡提供了[2.3 億至2.5 億美元] 之間更大的透明度，我想說，這本身就非常接近我們在本季度看到的6%，今年。當然，在我們前進的過程中，我們將在 2 月份第四季後提供 '24 的指導。但仔細想想，根據我們的策略，這將占我們未來收入的 6% 到 6.5% 之間。而這主要與研發中創新腳的搭配有關。

Thanks Eli. And then moving on to UZEDY, and we talked a bit, I think the question is around the positivity we have and then next year, so I'll hand that to Sven, Head of North America who can give some flavor for the excitement in the market.

謝謝伊萊。然後轉向 UZEDY，我們聊了一會兒，我認為問題在於我們明年的積極性，所以我將把這個問題交給北美負責人 Sven，他可以給我們帶來一些興奮的感覺。市場。

Yes. Thank you, Richard. So we have a very good uptake. Our launch plan is full on track. We are, of course, now working towards market access. In hospital access, listing on hospital formularies, we are right on plan. Medicaid and Medicare, we are also in discussions here. We have secured on par access with Invega Sustenna in a couple of states, and we are working towards this goal with all the remaining states, but also with the Medicare plans so that we are quite confident that we will have a very good market access position going into 2024.

是的。謝謝你，理查。所以我們有很好的吸收率。我們的發布計劃已完全步入正軌。當然，我們現在正在努力爭取市場准入。在醫院准入方面，在醫院處方集上列出，我們的計劃是正確的。醫療補助和醫療保險，我們也在這裡討論。我們已經在幾個州獲得了與 Invega Sustenna 同等的准入機會，我們正在與所有其餘州以及醫療保險計劃一起努力實現這一目標，因此我們非常有信心我們將擁有非常好的市場准入地位進入2024年。

What is very encouraging for us is that the product profile that we hope for will find a good reception with positions actually plays out as planned. We've generated so far about 4,000 prescriptions. Please keep in mind that we have a large number of free samples in the market to get patients started. So when we move forward and have utilized these samples, we will see more paid for prescriptions. But we get to -- so today, the majority of our patients switches from oral therapies to UZEDY and then from -- within the category of switches from other LAIs to UZEDY, we have here sources of revenues that come primarily, of course, from the respirator market from PERSERIS and Consta but also from the other LAIs. So we believe what we always hope for -- aim for that this becomes a new standard of care in the LAI segment will actually materialize. And for that reason, we believe that UZEDY will be then a material contributor to our both in innovative medicines in 2024 and going forward from there.

對我們來說非常令人鼓舞的是，我們希望的產品簡介能夠獲得良好的反響，並且實際上按計劃發揮了作用。到目前為止，我們已經產生了大約 4,000 個處方。請記住，我們在市場上有大量免費樣品可以幫助患者開始使用。因此，當我們繼續前進並利用這些樣本時，我們將看到更多的處方付費。但我們現在——所以今天，我們的大多數患者從口服療法轉向 UZEDY，然後從——在從其他 LAI 轉向 UZEDY 的類別中，我們這裡的收入來源當然主要來自PERSERIS 和Consta 的呼吸器市場以及其他LAI 的呼吸器市場。因此，我們相信我們一直希望成為 LAI 領域新的護理標準的目標將會真正實現。因此，我們相信 UZEDY 將在 2024 年及以後為我們的創新藥物領域做出重大貢獻。

Our next question comes from Ash Verma of UBS.

我們的下一個問題來自瑞銀集團的 Ash Verma。

This (inaudible) asking question on behalf of Ash. So I have 2. The first one is on AUSTEDO. Can you give us some color on where the XR is taking share from? So now run rate is at around like 10% of total molecule. So I just want to understand, is it taking share from regular AUSTEDO, generics or INGREZZA.

這個（聽不清楚）代表 Ash 提出問題。所以我有 2 個。第一個是 AUSTEDO。您能否告訴我們 XR 的市佔率來自何處？所以現在運行率約為總分子的 10%。所以我只是想了解，它是否從常規 AUSTEDO、仿製藥或 INGREZZA 中奪取了份額。

The second question is on [stand-alone] business. Can you give us a rough sense for what's the EBITDA margin for the stand-alone business? Also curious how that margin profile has been trending for the last few years?

第二個問題是關於[獨立]業務。您可以跟我們大致介紹一下獨立業務的 EBITDA 利潤率是多少嗎？還想知道過去幾年利潤率的趨勢如何？

I'll hand over the AUSTEDO question to Sven who can give a bit more detail on that.

我會將 AUSTEDO 問題交給 Sven，他可以提供更多詳細資訊。

Yes. Thanks for the question. So if our uptake is strong, we have a higher share actually in the total business than the 10% that you mentioned. So far, we get about 1/3 of our new patient starts on AUSTEDO XR and the other 2/3 on BID, of course, that's an annualized figure. It's now ramping up, that XR becomes much, much more prominent in new patient starts. And the sources of patients in itself for these patient starts are around about half of them are naive patients that start neuron therapy for [VEMAT2] inhibitor and the other half come either from BID switches -- from AUSTEDO BID or from INGREZZA or tetrabenazine. So here, what is encouraging for us is that we have a significant number of new prescribers that have never prescribed AUSTEDO before they now start prescribing AUSTEDO XR because they value the convenience of a once-daily formulation. And I think that's very good for us because that is a market segment that we could not access before in the absence of a once-daily formulation. So for that reason here, I think we are right on track in making AUSTEDO continuous growth driver for our innovative business.

是的。謝謝你的提問。因此，如果我們的吸收率很強，那麼我們實際上在總業務中所佔的份額比您提到的 10% 還要高。到目前為止，我們大約 1/3 的新患者開始使用 AUSTEDO XR，另外 2/3 開始使用 BID，當然，這是年化數字。現在它正在加速發展，XR 在新患者開始中變得更加突出。這些患者本身的來源大約有一半是開始接受 [VEMAT2] 抑制劑神經元治療的初始患者，另一半來自 BID 開關——來自 AUSTEDO BID 或來自 INGREZZA 或丁苯那嗪。因此，令我們感到鼓舞的是，我們有大量新處方者在開始開立 AUSTEDO XR 處方之前從未開過 AUSTEDO 處方，因為他們重視每日一次配方的便利性。我認為這對我們來說非常好，因為這是一個我們以前在沒有每日一次配方的情況下無法進入的細分市場。因此，出於這個原因，我認為我們正走上正軌，讓 AUSTEDO 成為我們創新業務的持續成長動力。

Thank you, Sven. And to your second question about Teva api guidance on EBITDA, both past and present in future, we are not giving any level of detail on EBITDA for Teva api this moment. Thank you.

謝謝你，斯文。關於您關於 Teva api 對 EBITDA 的指導的第二個問題，無論是過去的還是現在的未來，我們目前不會提供有關 Teva api 的 EBITDA 的任何詳細資訊。謝謝。

Our next question comes from Glen Santangelo from Jefferies.

我們的下一個問題來自 Jefferies 的 Glen Santangelo。

Just 2 quick ones for me. Obviously, with so much focus on the innovative pipeline, generics often get overlooked. I mean Richard, it seems like the generics business had a great quarter, particularly in North America. The trend seems to be getting a little bit stronger. I was wondering if you could just sort of comment on the competitive and pricing dynamics that may be driving that trend?

對我來說只有 2 個快速的。顯然，由於過度關注創新管道，仿製藥常常被忽略。我的意思是理查德，仿製藥業務似乎有一個很好的季度，特別是在北美。趨勢似乎變得更強了一些。我想知道您是否可以對可能推動這一趨勢的競爭和定價動態發表評論？

And then secondly, as it relates to the Alvotech partnership, the company made an additional investment there in the wake of a number of CRLs right, more recently on [SOLAR]. Could you give us an update on that relationship and the biosimilar pipeline as it relates to that Alvotech partnership?

其次，由於與 Alvotech 合作夥伴關係相關，該公司在一系列 CRL 之後進行了額外投資，最近在 [SOLAR] 上進行了投資。您能否向我們介紹與 Alvotech 合作關係相關的關係和生物相似藥管道的最新情況？

Thanks, Glen. Thanks for the question. So we are pleased about the performance of our generics business. I think this is journey and our strategy to make sure Generics business is a sustainable powerhouse. And within North America, we've obviously seen a strong quarter there. I think Eli did highlight a big contributor to that was Revlimid. What I would say about your sort of more general market conditions around more favorability, and I've been consistent on this.

謝謝，格倫。謝謝你的提問。因此，我們對仿製藥業務的表現感到滿意。我認為這是確保仿製藥業務成為可持續發展動力的旅程和策略。在北美地區，我們顯然看到了強勁的季度表現。我認為 Eli 確實強調了來那度胺 (Revlimid) 的一個重要貢獻者。我想說的是關於更有利的更普遍的市場條件，我在這一點上一直是一致的。

I think to be -- the market conditions will change based on supply-demand and competition, and that will be constant. And so as more people come into a market the prices will go down because the competition will drive that. I don't see those dynamics changing. There will be quarters where the pricing pressure is less than the quarters when the pricing pressure is more. I think for our strategy to make sure we can be in control of that, we focused our R&D engine under Eric Hughes and making sure we deliver our generics and our complex generics on time and first to the market more than we have done in the past. And that's where we'll drive value creation and we'll ensure ourselves against this volatility within the market. So I think that's how we think about market going forward and how we think about making sure we stay competitive and have a sustainable business.

我認為，市場狀況將根據供需和競爭而變化，而且這種變化將是不變的。因此，隨著越來越多的人進入市場，價格將會下降，因為競爭將推動價格下降。我沒有看到這些動態發生變化。有些季度的定價壓力會小於定價壓力較大的季度。我認為，為了確保我們能夠控制這一點，我們的策略是，我們將研發引擎集中在埃里克·休斯（Eric Hughes）的領導下，並確保我們按時交付我們的仿製藥和複雜的仿製藥，並且比我們過去所做的更多。 。這就是我們推動價值創造的地方，我們將確保自己免受市場波動的影響。所以我認為這就是我們對市場未來發展的看法，以及我們如何確保我們保持競爭力並擁有永續的業務。

With regard to Alvotech and the partnership, the relationship is actually very good. I mean one of the things we did when we invested again into this partnership is, and I've said this before as well, Alvotech is very good when it comes to developing biosimilar. Their R&D capability, I think we will have the best product in the market if we launch Humira -- from a device point of view or a product profile interchangeability, they're very good at that.

關於Alvotech和合作關係，實際上關係非常好。我的意思是，當我們再次投資這種夥伴關係時，我們所做的一件事是，我之前也說過，Alvotech 在開發生物相似藥方面非常出色。他們的研發能力，我認為如果我們推出修美樂，我們將擁有市場上最好的產品——從設備的角度或產品配置的可互換性來看，他們非常擅長這一點。

What we're doing is working even more closely with them to ensure that from a manufacturing capability we can help them not only get through the FDA inspection, but also be able to be -- able to deliver the volumes that we see will be necessary. And that's something which we're very careful at because we have 53 sites, we have roughly 30 FDA inspections a year. So we do know what we're doing.

我們正在做的是與他們更密切地合作，以確保我們不僅能夠透過製造能力幫助他們通過 FDA 檢查，而且能夠交付我們認為必要的數量。我們對此非常謹慎，因為我們有 53 個地點，每年大約有 30 次 FDA 檢查。所以我們確實知道我們在做什麼。

But I think what -- maybe to conclude, the relationship is very strong. Our pipeline, we've expanded with them because we see that capability. We continue to build out our pipeline through partnerships. So you'll see some announcements on that, hopefully, in the future because we do believe our strategy is to have a broad portfolio, predominantly through partnerships and that allows us to go to the market with the portfolio play and also to ensure ourselves against the peaks and troughs that associated with launching biosimilars 1 year and then maybe not having them in the next. So hopefully that answers your question, Glen, and I appreciate the call.

但我認為——也許可以得出結論，這種關係非常牢固。我們已經與他們一起擴展了我們的管道，因為我們看到了這種能力。我們繼續透過合作夥伴關係建立我們的管道。因此，希望您將來會看到一些關於這方面的公告，因為我們確實相信我們的策略是擁有廣泛的投資組合，主要是透過合作夥伴關係，這使我們能夠透過投資組合進入市場，並確保自己免受與一年內推出生物相似藥相關的高峰和低谷，然後可能在下一年不再推出。希望這能回答你的問題，格倫，我很感謝你的來電。

Our next question comes from David Amsellem of Piper Sandler.

我們的下一個問題來自 Piper Sandler 的 David Amsellem。

A couple of high-level questions just on overall strategy. So with the upfront payment in hand from Sanofi. So you have a little more -- well room here, wiggle room here, I should say. And with that in mind, are you focused on assets in neuropsychiatry where you can leverage your commercial infrastructure that you have in place? Is that the top priority there?

有幾個關於總體策略的高級問題。因此，賽諾菲手頭上有預付款。所以你還有更多的空間——我應該說，這裡有良好的空間，這裡有迴旋的空間。考慮到這一點，您是否專注於神經精神病學領域的資產，您可以利用您現有的商業基礎設施？這是那裡的首要任務嗎？

And then secondly, as it relates to biosims, just coming back to Viatris getting out of that business. How do you think about your role in biosims going forward? I know what you're saying in your comments, but is that something you could be opportunistic about going forward in terms of monetizing that business?

其次，因為它與生物模擬有關，所以回到 Viatris 退出該業務的情況。您如何看待您在生物模擬領域未來的角色？我知道您在評論中所說的內容，但是您是否可以在透過該業務獲利方面投機取巧？

Thanks for the question, David. So starting with the -- I think I should say, because our financial situation improves with the TL1A deal and the $500 million upfront, we know how do we think about BD. So as I said, we are thinking about BD we're active. We're looking, we've hired Angus Grant, a seasoned professional director, legend in the industry who's worked at innovative medicines all his life. And so we really have stepped up that and our capability around that and our focus on that.

謝謝你的提問，大衛。因此，首先，我想我應該說，因為我們的財務狀況隨著 TL1A 交易和 5 億美元的預付款而改善，我們知道我們如何看待 BD。正如我所說，我們正在考慮積極開展 BD 業務。我們正在尋找，我們聘請了安格斯·格蘭特（Angus Grant），他是一位經驗豐富的專業總監，也是行業的傳奇人物，一生致力於創新藥物。因此，我們確實加強了這一點以及我們圍繞這一點的能力以及我們對此的關注。

Now yes, we are targeting CNS immunology and within CNS, we do obviously psychiatry and neurology because we see the synergy play there. We believe in the capability. In fact, in psychiatry, I think we're seen as one of the leaders in psychiatry now. So I think it makes sense to look back. That said, as opportunities come along, which may be in a broader CNS will look at them. But right now, we are ensuring we stay focused to make sure we allocate our capital in a way that will be synergistic to our P&L and maximize our OpEx.

現在，是的，我們的目標是中樞神經系統免疫學，在中樞神經系統內，我們顯然從事精神病學和神經學研究，因為我們看到了那裡的協同作用。我們相信我們的能力。事實上，在精神病學領域，我認為我們現在被視為精神病學領域的領導者之一。所以我認為回顧過去是有道理的。也就是說，隨著機會的出現，中樞神經系統可能會在更廣泛的範圍內關注它們。但現在，我們正在確保我們保持專注，以確保我們以一種與我們的損益協同並最大化我們的營運支出的方式分配我們的資本。

With regard to the biosims question, I think our strategy is really clear. I think biosimilars is a massive opportunity to generate revenue. I've seen that in Europe. I believe that's going to happen in the United States. It will be a bit bumpy in the United States as we've seen in the past. But we've also seen with TRUXIMA, rituximab it's a great revenue generator. So the way we address maybe some of that uncertainty is to ensure that we don't allocate a huge amount of capital to it by doing that through partnerships. And we built a broad portfolio. So when some assets come to the market in a timely manner, or some assets overachieve and other assets underachieve and what their peak sales could look like. We're balancing that out because we have a portfolio approach. But we feel very clear on our strategy and committed to our strategy. We think it's the right strategy for a company like Teva. Thanks for your question, David.

關於生物模擬問題，我認為我們的策略非常明確。我認為生物相似藥是一個巨大的創收機會。我在歐洲見過這樣的情況。我相信這將在美國發生。正如我們過去所看到的那樣，美國的情況會有點坎坷。但我們也看到 TRUXIMA、利妥昔單抗是一個巨大的收入來源。因此，我們解決部分不確定性的方法可能是確保我們不會透過合作夥伴關係來分配大量資本。我們建立了廣泛的產品組合。因此，當某些資產及時進入市場，或某些資產超預期而另一些資產表現不佳時，它們的高峰銷售可能會是什麼樣子。我們正在平衡這一點，因為我們有投資組合方法。但我們對我們的戰略非常明確，並且致力於我們的戰略。我們認為這對梯瓦這樣的公司來說是正確的策略。謝謝你的提問，大衛。

Our final question for today comes from Chris Schott of JPMorgan.

我們今天的最後一個問題來自摩根大通的克里斯·肖特。

This is Katerina on for Chris. So first on gross margins, I know you're not giving guidance for next year, but as we think about margin trajectory from here and the trends we saw in Q3 and what we're going to see in Q4. Is that kind of the correct starting point as we think about gross margin next year? Or are there any other pushes and pulls we should keep in mind there?

這是克里斯的卡特琳娜。首先是毛利率，我知道您不會給出明年的指導，但當我們考慮這裡的利潤軌跡以及我們在第三季度看到的趨勢以及我們將在第四季度看到的情況時。當我們考慮明年的毛利率時，這是正確的起點嗎？或者我們還應該牢記其他什麼推力和拉力？

And I think the second question is just on AUSTEDO. It seems like the product has had a very strong quarter. Just want us thinking around kind of investing behind that product and support for the asset? How are you thinking about balancing cost versus kind of maximizing the revenue opportunity, has it thinking evolved at all? And any implications as we think about SG&A spend next year?

我認為第二個問題是關於 AUSTEDO 的。該產品似乎經歷了一個非常強勁的季度。只是想讓我們考慮該產品背後的投資類型以及對該資產的支持嗎？您如何考慮平衡成本與最大化收入機會，它的思維是否有所發展？當我們考慮明年的 SG&A 支出時，有什麼影響嗎？

Thank you, Katerina. I'll take a go at both of that and also allow my colleagues Sven and Eli to contribute. So when we think about margin -- when I think about margin going forward, it's aligned to our strategy. So when you think about our pivot to growth strategy, it was to make the company get back to growth, but growth in an area where it will drive profitability at the top and the bottom line.

謝謝你，卡特琳娜。我將嘗試這兩點，並允許我的同事 Sven 和 Eli 做出貢獻。因此，當我們考慮利潤率時——當我考慮未來的利潤率時，它與我們的策略是一致的。因此，當你考慮我們轉向成長策略時，它是為了讓公司恢復成長，但成長的領域將推動頂部和底部的獲利能力。

Now obviously, I think Eli has just highlighted and I highlighted in my comments that we improved gross margin by 50 basis points. Where we did that primarily is our portfolio mix. So as we drive the AUSTEDO, as we drive AJOVY, as we drive UZEDY, as we bring olanzapine to the market, AUSTEDO to the market, those products have a very different gross margin profile than our generics business. And so that definition will raise our gross margin. So that's sort of the big picture on it.

現在顯然，我認為 Eli 剛剛強調了，我在評論中也強調了我們的毛利率提高了 50 個基點。我們所做的主要是我們的投資組合。因此，當我們推動 AUSTEDO、當我們推動 AJOVY、當我們推動 UZEDY 時、當我們將奧氮平推向市場、將 AUSTEDO 推向市場時，這些產品的毛利率狀況與我們的仿製藥業務截然不同。因此，這個定義將提高我們的毛利率。這就是它的大局。

I'll let Eli, give a bit more flavor, if you want to, Eli.

如果你願意的話，我會讓伊萊再給你一點味道，伊萊。

Yes. So just you know we are still actually aligned with our long-term financial targets by 2027 to reach the 30% on OP, which means if you look on our trajectory in OpEx and as we are very, very cautioned on even that we're actually dollars spend higher, but you're trending it always versus revenue this year and last year. And we believe that between 26% to 27% OpEx going forward, which means that those gross margin of 55% to 57% on the long term should serve our goals.

是的。所以你知道，我們實際上仍然與我們的長期財務目標保持一致，到 2027 年達到 OP 的 30%，這意味著如果你看看我們在營運支出方面的軌跡，因為我們非常非常謹慎，即使我們實際上，美元支出更高，但你總是將其趨勢與今年和去年的收入進行比較。我們認為，未來營運支出將在 26% 至 27% 之間，這意味著從長遠來看，55% 至 57% 的毛利率應該符合我們的目標。

And then moving on to AUSTEDO. For AUSTEDO, we think we have a very important asset here. And because of that, we ensure that, that is funded in the appropriate way. And obviously, we have a big cost base at Teva. And so for us, it's about prioritization. And AUSTEDO is one of the top priorities we have in this company. And so when it comes to getting resources. Obviously, there's a process to do that. It's not quite an open checkbook for Sven and his team, but it's very much -- this is an asset we want to maximize, let's understand what that takes. And then obviously manage that through other aspects of the business cost structure to make sure we can offset that as much as we can to once again, stay very on top of our spend. As our revenue grows, we want to make sure our profitability goes with it.

然後繼續前往 AUSTEDO。對於 AUSTEDO 來說，我們認為我們在這裡擁有非常重要的資產。正因為如此，我們確保以適當的方式提供資金。顯然，梯瓦（Teva）擁有巨大的成本基礎。所以對我們來說，這就是優先順序。 AUSTEDO 是我們公司的首要任務之一。在獲取資源方面也是如此。顯然，有一個過程可以做到這一點。對於斯文和他的團隊來說，這並不是一本開放的支票簿，但它非常重要——這是我們想要最大化的資產，讓我們了解這需要什麼。然後顯然可以透過業務成本結構的其他方面來管理這一點，以確保我們能夠盡可能地抵消這一點，從而再次控制我們的支出。隨著我們的收入成長，我們希望確保我們的獲利能力隨之成長。

But Sven, do you have anything else to add to that?

但是斯文，你還有什麼要補充的嗎？

Yes. I think what an advantage that we have is, of course, that we can make synergistic investment between AUSTEDO and UZEDY because some of the prescribers that we target prescribe both of the brands. So we have to leverage and we can create some scale effects. We have this year stepped up our sales force. We have increased our long-term care team. We have made investments in specialty pharmacy programs to increase our fill rates, and we are also working on adherence. And I believe the fact that the prescriber base increases as more and more physicians start prescribing [VMAT2] inhibitors, it naturally leads you to an opportunity to invest more behind sales and patient activation and that's what we also plan to do for 2024. But as Richard said, of course, we are quite disciplined in analyzing where we want to invest our dollars.

是的。當然，我認為我們擁有的一個優點是，我們可以在 AUSTEDO 和 UZEDY 之間進行協同投資，因為我們針對的一些處方醫生同時開這兩個品牌的處方。所以我們必須發揮槓桿作用，我們可以創造一些規模經濟。今年我們加強了銷售團隊。我們增加了長期照護團隊。我們對專業藥房項目進行了投資，以提高我們的填充率，並且我們也在努力提高依從性。我相信，隨著越來越多的醫生開始開出[VMAT2] 抑制劑處方，處方者基礎不斷增加，這自然會為您帶來在銷售和患者活化方面進行更多投資的機會，這也是我們計劃在2024 年做的事情。理查德說，當然，我們在分析我們想投資的地方時非常自律。

Thank you, Sven. And I'd like to thank everybody for taking the time to listen to our call and to answer the questions. We do appreciate the interest in Teva. And I wish everybody a good day or a good evening. Thank you.

謝謝你，斯文。我要感謝大家花時間聆聽我們的電話並回答問題。我們非常感謝大家對 Teva 的興趣。我祝大家有個美好的一天或美好的夜晚。謝謝。

Thank you for joining today's call. You may now disconnect your lines.

感謝您參加今天的電話會議。現在您可以斷開線路。