(TEVA) 2023 Q2 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Hello, and welcome to the Q2 2023 at Teva Pharmaceutical Industries Limited Earnings Conference Call. My name is Alex. I'll be coordinating the call today. (Operator Instructions) I will now hand over to your host, Ran Meir, Head of Investor Relations. Please go ahead.

    您好,歡迎參加梯瓦製藥工業有限公司 2023 年第二季度收益電話會議。我的名字叫亞歷克斯。我今天將協調通話。 (操作員指示)我現在將會議交給主持人投資者關係主管 Ran Meir。請繼續。

  • Ran Meir - Head of IR

    Ran Meir - Head of IR

  • Thank you, Alex. Thank you, everyone, for joining us today. We hope you have had the 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 on our 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上午早些時候發布的新聞稿。您可以在我們的網站 tevapharm.com 上找到本新聞稿的副本以及本次電話會議中演示的幻燈片的副本。

  • 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.

    請查看我們在幻燈片 #2 上的前瞻性陳述。有關這些報表和我們的非 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 Q2 2023 results and business performance as well as recent trends 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, Eliyahu 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 we follow the presentation. Please note that today's call will run approximately 1 hour. And with that, I will now turn the call over to Richard. Richard, if you would, please?

    在今天的電話會議中,Teva 首席執行官理查德·弗朗西斯 (Richard Francis) 將概述 Teva 2023 年第二季度的業績和業務績效,以及近期趨勢和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。我們的首席財務官 Eliyahu Kalif 隨後將更詳細地審查財務業績,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,他將在我們演示後的問答環節中出席。請注意,今天的通話將持續大約 1 小時。現在,我將把電話轉給理查德。理查德,你願意嗎?

  • Richard D. Francis - President, CEO & Director

    Richard D. Francis - President, CEO & Director

  • Thank you, Ran, and thank you, everybody, for joining our call. I'm very pleased to update you on our Q2 performance and the progress we are making on executing our pivot to growth strategy. It's been an exciting quarter with the launch of AUSTEDO XR once-a-day formulation and the launch of UZEDY, a long-acting treatment for schizophrenia. Now moving to Slide #4. Let's start with our results. Revenue was up 4% in local currencies to $3.9 billion, and non-GAAP gross margin was at 52.2%, up 3.1% versus Q1.

    謝謝你,蘭,謝謝大家加入我們的電話會議。我很高興向您介紹我們第二季度的業績以及我們在執行轉向增長戰略方面所取得的進展。這是一個激動人心的季度,推出了 AUSTEDO XR 每日一次配方以及 UZEDY(一種精神分裂症長效治療藥物)。現在轉到幻燈片 #4。讓我們從我們的結果開始。以當地貨幣計算的收入增長 4%,達到 39 億美元,非 GAAP 毛利率為 52.2%,較第一季度增長 3.1%。

  • Adjusted EBITDA was at $1.1 billion. Based on this, we are increasing our revenues outlook for 2023 to $15 billion to $15.4 billion. I'm also pleased to highlight that we've got good momentum on our Pivot to Growth strategy with good execution across the 4 pillars driving this growth, and I'll give you an update on those in the presentation as well. Now digging down a bit into this performance and this 4% on the next slide.

    調整後 EBITDA 為 11 億美元。基於此,我們將 2023 年的收入預期上調至 150 億至 154 億美元。我還很高興地強調,我們的“以增長為中心”戰略勢頭良好,在推動這一增長的四大支柱上得到了良好的執行,我還將向您介紹演示中的最新情況。現在在下一張幻燈片上深入研究一下這個性能和 4%。

  • This was driven by our growth engines. And as you can see here, there's a 51% increase in revenue for AUSTEDO strong performance there. AJOVY continues to perform and in North America grew 16% and in Europe, 32%. We continue to see good growth in our international markets at 13% of our generics business and Europe came in at plus 2%. Now maybe to dig a bit deeper on a sales performance on the next slide. I believe we're on track to hit the $1.2 billion target we set for 2023.

    這是由我們的增長引擎推動的。正如您在此處所看到的,由於 AUSTEDO 的強勁表現,收入增長了 51%。 AJOVY 繼續表現出色,在北美增長了 16%,在歐洲增長了 32%。我們繼續看到國際市場的良好增長,仿製藥業務增長了 13%,歐洲增長了 2%。現在也許要在下一張幻燈片上更深入地了解銷售業績。我相信我們有望實現 2023 年設定的 12 億美元目標。

  • As you can see, revenues for Q2 were $308 million, and that was a full 51% increase, strong continued TRx growth. I'd like to point out we did launch our once-a-day formulation in this quarter in May, which we're very pleased to bring this to patients with (inaudible).

    正如您所看到的,第二季度的收入為 3.08 億美元,足足增長了 51%,TRx 持續強勁增長。我想指出的是,我們確實在五月份的這個季度推出了每日一次的配方,我們很高興將其帶給患者(聽不清)。

  • But this obviously required us to put some stock in the channel. So if (inaudible) for this, the revenue growth was probably around about 35% to 40%. So still strong growth. And we continue to believe in the potential of AUSTEDO. If you move to the next slide, I talked about back in made our strategy launch the $2.5 billion that we will achieve in 2027. And we're reaffirming this -- and this is based on 2 particular points.

    但這顯然需要我們在渠道中投入一些庫存。因此,如果(聽不清)這一點,收入增長可能約為 35% 至 40%。所以仍然強勁增長。我們仍然相信 AUSTEDO 的潛力。如果你翻到下一張幻燈片,我在我們的戰略啟動中談到了我們將在 2027 年實現 25 億美元的目標。我們重申這一點 - 這是基於兩個特定點。

  • One is the unmet medical need that's out there, the undertreated population. As you can see on this slide on the right, there are 785,000 patients suffering from tardive dyskinesia, and only 120,000 are actually diagnosed and only a small amount of those are treated. So there's a significant unmet medical need.

    一是醫療需求未得到滿足,即未得到充分治療的人群。正如您在右側這張幻燈片中所看到的,有 785,000 名遲發性運動障礙患者,但實際上只有 120,000 人被診斷出來,並且其中只有一小部分得到了治療。因此,存在大量未滿足的醫療需求。

  • So obviously, we have (inaudible) to put a lot of focus around AUSTEDO both in resources and in managerial focus. And this is allowing us to increase our sales force increase the support we put in around patients.

    顯然,我們(聽不清)必須在資源和管理重點方面對 AUSTEDO 投入大量精力。這使我們能夠增加銷售隊伍,增加對患者的支持。

  • We've launched the one today. We continue to raise awareness, so we can get some of these patients who are not on treatment into the physician's office to get on to AUSTEDO.

    我們今天推出了這一產品。我們不斷提高人們的認識,這樣我們就可以讓一些未接受治療的患者到醫生辦公室去接受 AUSTEDO。

  • We also are still confident that we will be able to take AUSTEDO to the European market. So we reaffirm our belief that we can hit $2.5 billion by 2027. Moving on to next slide and another member of our innovative family is AJOVY. Now AJOVY continues to grow 17% versus Q2 2022. And I think this highlights the capability we have here at Teva to launch products into competitive markets as before.

    我們仍然有信心能夠將 AUSTEDO 推向歐洲市場。因此,我們重申我們的信念,即到 2027 年我們的銷售額可以達到 25 億美元。接下來看下一張幻燈片,我們創新家族的另一位成員是 AJOVY。現在,AJOVY 與 2022 年第二季度相比繼續增長 17%。我認為這凸顯了我們 Teva 一如既往地向競爭市場推出產品的能力。

  • We will hit our guidance of $400 million till 2023 and we continue to see that we overall grow market share across many of our markets.

    到 2023 年,我們將達到 4 億美元的目標,並且我們將繼續看到我們在許多市場的整體市場份額不斷增長。

  • Now moving on to Slide #9 and the newest member of our innovative family UZEDY, risperidone our long-acting treatment for schizophrenia. I have to remind everybody, this is a $4 billion market. And we really just launched UZEDY, but we're very pleased with the feedback we're getting from health care professionals. And they're confirming that the profile that we have with UZEDY is unique and advantageous. Now we're seeing this and the fact that our NBRx is 40%. So already, we're getting 40% of the risperidone long-acting market. We're also seeing hospitals look to use our free samples and free trial requests and we're having good discussions with our payers. So once again, I think [statement] around UZEDY early days, but initial feedback is very positive.

    現在轉到第 9 張幻燈片,我們創新系列 UZEDY 的最新成員,利培酮是我們治療精神分裂症的長效藥物。我必須提醒大家,這是一個40億美元的市場。我們確實剛剛推出了 UZEDY,但我們對從醫療保健專業人士那裡得到的反饋感到非常滿意。他們確認我們與 UZEDY 的關係是獨特且有利的。現在我們看到了這一點以及我們的 NBRx 為 40% 的事實。因此,我們已經獲得了 40% 的利培酮長效市場份額。我們還看到醫院希望使用我們的免費樣品和免費試用請求,我們正在與付款人進行良好的討論。因此,我再次認為 [聲明] 是關於 UZEDY 早期的,但最初的反饋是非常積極的。

  • And if I move on to Slide #10 to give you probably a reason why we're getting this feedback. We already had reports that show the product profile that we put forward, the subcutaneous needle, the lack of need for refrigeration, prefilled syringe has allowed us to have a product that patients 9 out of 10 patients are very satisfied with. And obviously, when it comes to position, we have the same 9 out of 10.

    如果我繼續看第 10 張幻燈片,可能會告訴您我們收到此反饋的原因。我們已經有報告顯示了我們提出的產品概況,皮下注射針,無需冷藏,預充式註射器使我們能夠擁有十分之九的患者對產品非常滿意的產品。顯然,就位置而言,十分之九我們是相同的。

  • And what we have found already is particularly advantageous is the fact that we don't need a loading dose and there are no oral supplements needed, one injection and the patient will get to a therapeutic dose within 24 hours.

    我們已經發現,特別有利的是,我們不需要負荷劑量,也不需要口服補充劑,一次注射,患者將在 24 小時內達到治療劑量。

  • Now clearly, that's advantageous when it comes to a patient having a relapse and needing to get that efficacy quickly. So good patient profile, good product profile and physicians excitement for UZEDY continues to grow.

    現在顯然,這對於病情復發並需要快速獲得療效的患者來說是有利的。良好的患者概況、良好的產品概況和醫生對 UZEDY 的興奮持續增長。

  • Now moving on to our generics business on Slide #11. Good growth in international, up 13%. Continued growth in Europe, a bit softer than the prior quarter. And this is down to a couple of factors. One is we did have a strong prior year, and there is some seasonality in our business, and that's impacted. That said, H1 will still show a 7% growth versus H1 2022. And I remain confident in this business going forward based on our portfolio, the scale, our pipeline and our commercial expertise.

    現在轉到幻燈片 #11 上的仿製藥業務。國際增長良好,增長13%。歐洲持續增長,但比上一季度略有放緩。這取決於幾個因素。一是我們前一年確實表現強勁,而且我們的業務存在一些季節性,這受到了影響。也就是說,與 2022 年上半年相比,上半年仍將實現 7% 的增長。基於我們的投資組合、規模、管道和商業專業知識,我對這項業務的未來發展仍然充滿信心。

  • Moving on to Slide #12 on our biosimilar. I'd like to update you on the progress we're making on our pivot to growth strategy. Now if you remember, the focus here was about having a broad biosimilar portfolio, and we've made some progress here. We have expanded our partnership with Alvotech. We have 4 new biosimilar candidates. We've also strengthened our operational relationship with Alvotech, helping them on manufacturing and quality where they can really leverage the scale and expertise we have at Teva.

    繼續看幻燈片#12,了解我們的生物仿製藥。我想向您介紹我們在轉向增長戰略方面所取得的最新進展。現在,如果您還記得的話,這裡的重點是擁有廣泛的生物仿製藥產品組合,我們已經在這方面取得了一些進展。我們擴大了與 Alvotech 的合作夥伴關係。我們有 4 種新的生物仿製藥候選藥物。我們還加強了與 Alvotech 的運營關係,幫助他們在製造和質量方面真正利用我們在 Teva 擁有的規模和專業知識。

  • We'll continue to seek to expand our portfolio. And as we do this and engage in more relationships, we'll update you as and when they happen.

    我們將繼續尋求擴大我們的產品組合。當我們這樣做並建立更多關係時,我們會在發生這些情況時向您通報最新情況。

  • Now moving on to Slide #13. Eric will obviously go into some detail on our pipeline, which we're very excited about. We continue to make good progress. But I really wanted to highlight the fact that the 3 late-stage assets we have favorable product profiles of the markets that are [entering] into, but also these are significant markets. So with Olanzapine, I've already highlighted the fact that it's a $4 billion market, we do manage to bring this to the market with a favorable safety profile.

    現在轉到幻燈片 #13。埃里克顯然會詳細介紹我們的管道,我們對此感到非常興奮。我們繼續取得良好進展。但我真的想強調這樣一個事實,即我們擁有正在[進入]的市場的良好產品概況的 3 個後期資產,而且這些都是重要的市場。因此,對於奧氮平,我已經強調了這樣一個事實:這是一個價值 40 億美元的市場,我們確實設法以良好的安全性將其推向市場。

  • I think we have a real opportunity to have a significant product on our hands here. ICS/SABA it's a $2.5 billion market. And then obviously, anti-TL1A is we been well discussed and this is a significant market, which would help to drive long-term growth for Teva.

    我認為我們有真正的機會在這裡擁有重要的產品。 ICS/SABA 這是一個 25 億美元的市場。顯然,我們已經充分討論了抗 TL1A 藥物,這是一個重要的市場,這將有助於推動 Teva 的長期增長。

  • Now moving on to the next slide on our ESG. We remain very committed to our ESG strategy, and we've made good progress across a number of goals. Just to highlight a few. I'm pleased that we've donated nearly up to 17 million doses of our medicines to improve access. We've also seen on our environmental so a 24% reduction in our greenhouse gas emissions. And actually, in quarter 2, we recently signed an agreement with an energy supplier in Israel to make sure that 100% of our electricity is from renewable sources, and that includes all our manufacturing sites as well.

    現在轉到我們的 ESG 下一張幻燈片。我們仍然非常致力於我們的 ESG 戰略,並且我們在許多目標方面都取得了良好進展。只是為了強調一些。我很高興我們捐贈了近 1700 萬劑藥品來改善獲取情況。我們還看到,在環境方面,我們的溫室氣體排放量減少了 24%。事實上,在第二季度,我們最近與以色列的一家能源供應商簽署了一項協議,以確保我們 100% 的電力來自可再生能源,這也包括我們所有的製造工廠。

  • Moving on to Slide #15, our final slide before I hand over to Eric. Is just highlight the progress we're making on our pivot to growth strategy, which we launched back in May. It's based on 4 pillars. On our first pillar to deliver on our growth engines, as I've highlighted, AUSTEDO is performing well, and we're confident about hitting $2.5 billion.

    繼續看幻燈片 #15,這是我交給 Eric 之前的最後一張幻燈片。這只是強調我們在五月份推出的轉向增長戰略方面所取得的進展。它基於 4 個支柱。正如我所強調的,在我們實現增長引擎的第一個支柱上,AUSTEDO 表現良好,我們有信心達到 25 億美元。

  • Eric will talk to you a bit about the progress we're making in the clinic on our late-stage assets but he's put together a world-class leadership team to help make sure we can drive our complex generics business as well as our innovative pipeline. When it comes to creating a sustainable generics powerhouse, we're making good progress on focusing on our R&D portfolio and our portfolio in our manufacturing setup to make sure we can drive efficiencies there. And finally, TAPI we've made the decision and to move that business to a stand-alone unit, and that is progressing very well. With that, I'm going to hand over to Eric to walk us through some of those assets I've touched upon.

    埃里克(Eric)將與您談談我們在臨床後期資產方面取得的進展,但他組建了一支世界一流的領導團隊,以幫助確保我們能夠推動我們複雜的仿製藥業務以及我們的創新管道。在創建可持續仿製藥強國方面,我們在專注於我們的研發組合和製造體系中的投資組合方面取得了良好進展,以確保我們能夠提高那裡的效率。最後,TAPI 我們已經做出決定,將該業務轉移到一個獨立的部門,而且進展非常順利。接下來,我將讓 Eric 向我們介紹我所涉及的一些資產。

  • Eric A. Hughes - Executive VP of Global R&D and Chief Medical Officer

    Eric A. Hughes - Executive VP of Global R&D and Chief Medical Officer

  • Thank you, Richard. First on to AUSTEDO XR, next slide. We were very happy to see the efficacy of AUSTEDO at the time of our Phase III approval. We're very excited to see the long-term data recently presented at the American Academy of Neurology. You can see in this slide that over this 3-year period, there is a durability of response.

    謝謝你,理查德。首先是 AUSTEDO XR,下一張幻燈片。我們很高興在 III 期批准時看到 AUSTEDO 的功效。我們非常高興看到美國神經病學學會最近公佈的長期數據。您可以在這張幻燈片中看到,在這三年期間,響應具有持久性。

  • And in fact, there's a slight improvement over those 3 years, irrespective of the psychiatric underlying conditions. Now our goal now is to make these responses, this durability convenient for all patients. So with our approval of AUSTEDO XR this year, we're excited to bring us a lower pill burden and the convenience of once-a-day dosing to patients. And we will continue to provide AUSTEDO and AUSTEDO XR to our HCPs to provide as much flexibility in our treatment as possible.

    事實上,無論潛在的精神疾病如何,這三年來都有輕微的改善。現在我們的目標是讓這些反應、這種持久性為所有患者帶來方便。因此,隨著今年 AUSTEDO XR 的批准,我們很高興能為患者帶來更低的藥物負擔和每天一次給藥的便利。我們將繼續向我們的 HCP 提供 AUSTEDO 和 AUSTEDO XR,以便為我們的治療提供盡可能多的靈活性。

  • Next slide, as Richard noted, the product profile of UZEDY is very attractive to our HCPs. The subcutaneous injection is a small needle, no loading dose, no supplemental oral therapy and is provided in a prefilled syringe. But it's also important to note the efficacy. We've shown an 80% reduction in the risk of relapse and a significantly longer time to relapse. But when we talk about our data to our experts, one of the things that we note is that after the stabilization of patients on oral risperidone under the study we actually saw a slight improvement on the long-acting injectable of UZEDY in our study. So these are early days, but this is very encouraging to see such activity and improvement with the long-acting injection.

    下一張幻燈片,正如 Richard 指出的,UZEDY 的產品概況對我們的 HCP 非常有吸引力。皮下注射採用小針頭,無負荷劑量,無需補充口服治療,並以預裝注射器形式提供。但注意功效也很重要。我們已經證明復發風險降低了 80%,並且複發時間顯著延長。但當我們向專家談論我們的數據時,我們注意到的一件事是,在研究中口服利培酮的患者病情穩定後,我們實際上在我們的研究中看到了UZEDY 長效注射劑的輕微改善。所以現在還處於早期階段,但看到長效注射的這種活性和改善是非常令人鼓舞的。

  • On the next slide. So we have now a portfolio of products throughout the life cycle of drug development. We're excited to be bringing our anti-PD-1-IL2 program into the clinic early next year in oncology. We're advancing our anti-IL-15 program in celiac disease through our Phase I studies, and we have initiated a proof of mechanism study this year. We're excited to be in our Phase IIb study of TL1A in IBD.

    在下一張幻燈片上。因此,我們現在擁有貫穿藥物開發生命週期的產品組合。我們很高興能在明年初將我們的抗 PD-1-IL2 項目引入腫瘤學臨床。我們正在通過 I 期研究推進我們在乳糜瀉中的抗 IL-15 項目,並且我們今年已經啟動了機制研究證明。我們很高興能夠開展 TL1A 治療 IBD 的 IIb 期研究。

  • And we're already started our olanzapine LAI study, which is actually enrolling very well, and we'll be starting our ICS/SABA Phase III program next month.

    我們已經開始了奧氮平 LAI 研究,實際上入組情況非常好,我們將於下個月開始 ICS/SABA III 期項目。

  • Next slide, now a little bit more on olanzapine LAI. We're very excited by this product. Olanzapine as an oral agent accounts for 20% of the patients being treated today but only less than 1% of patients on the long-acting form are being -- using that product. And that's primarily because of the safety profile. The Zyprexa Relprevv has a black box warning for PDSS. And we've noted before, why we're very confident that our long-acting injectable olanzapine will not have PDSS unlike Zyprexa Relprevv, our product is a subcutaneous injection which avoids deep penetration as an intramuscular injection of Zyprexa Relprevv. And that will prevent in general, a lack of spikes in the PK exposure of the drug. In addition, our formulation rapidly aggregates into a slow-release formulation. And to add to our confidence, we did this in vitro study here you see in the graph.

    下一張幻燈片詳細介紹了奧氮平 LAI。我們對這個產品感到非常興奮。奧氮平作為口服藥物,佔目前接受治療的患者的 20%,但只有不到 1% 的長效形式患者正在使用該產品。這主要是因為安全性。 Zyprexa Relprevv 有針對 PDSS 的黑框警告。我們之前已經指出,為什麼我們非常有信心我們的長效注射用奧氮平不會像 Zyprexa Relprevv 那樣出現 PDSS,我們的產品是皮下注射劑,可以避免像 Zyprexa Relprevv 肌肉注射那樣的深層滲透。這通常可以防止藥物 PK 暴露出現峰值。此外,我們的配方快速聚集成緩釋配方。為了增加我們的信心,我們進行了這項體外研究,如圖所示。

  • And this is the worst case scenario. We took human serum. We injected Zyprexa Relprevv directly into the serum, and we could show a rapid dissolution and measurement of olanzapine in the serum. However, when we directly injected our formulation, which rapidly aggregates and forms a slower release formulation, even in this worst-case scenario, we have only a slow release and complete -- a clear differentiation from the Zyprexa Relprevv. So very encouraging results in vitro and we're excited to have our Phase III study ongoing right now.

    這是最壞的情況。我們採取了人血清。我們將 Zyprexa Relprevv 直接注射到血清中,我們可以顯示奧氮平在血清中的快速溶解和測量。然而,當我們直接注射我們的製劑時,它會迅速聚集並形成較慢釋放的製劑,即使在這種最壞的情況下,我們也只有緩慢的釋放和完全的釋放——這與Zyprexa Relprevv 明顯不同。體外實驗的結果非常令人鼓舞,我們很高興現在正在進行第三階段研究。

  • Next slide. So moving on to anti-TL1A. IBD remains a large underserved patient population. There are over 4 million patients diagnosed. Of those, about 2.7 million patients are treated. These patients frequently receive oral therapies as well and in the biologics that they have, they frequently cycle through those biologics due to lack of response. We're excited by our anti-TL1A program. We believe we have a best-in-class preclinical profile. We have well characterized the safety of our product, and we have also know that a low antidrug antibody profile.

    下一張幻燈片。那麼繼續抗TL1A。 IBD 仍然是一個得不到充分服務的龐大患者群體。確診患者已超過400萬。其中,約有 270 萬名患者接受治療。這些患者也經常接受口服治療,並且在他們擁有的生物製劑中,由於缺乏反應,他們經常循環使用這些生物製劑。我們對我們的抗 TL1A 計劃感到興奮。我們相信我們擁有一流的臨床前概況。我們已經很好地表徵了我們產品的安全性,並且我們還知道其抗藥物抗體譜較低。

  • We're accelerating our program in anti-TL1A in IBD, and we're allocating more resources and capital on this program, and we're excited to see in 2024, our interim results. This will drive our decision to start Phase III in 2025.

    我們正在加速 IBD 抗 TL1A 項目,並為此項目分配更多資源和資本,我們很高興在 2024 年看到我們的中期結果。這將促使我們決定在 2025 年啟動第三階段。

  • Next slide. So just to review why we believe we have a best-in-class compound. These in vitro assays here that you see on the screen are directly comparing our antibody to comparator reagents that we created that represent other clinical candidates in development. You can see that we have a greater selectivity of the DR3 receptor, which is the inflammatory receptor while maintaining the decoy receptor providing a clear differentiated biology of our antibody. We also demonstrate that we have greater potency compared to the other 2 clinical candidates.

    下一張幻燈片。因此,我們只是回顧一下為什麼我們相信我們擁有一流的化合物。您在屏幕上看到的這些體外測定直接將我們的抗體與我們創建的代表其他正在開發的臨床候選藥物的比較試劑進行比較。您可以看到,我們對 DR3 受體(炎症受體)具有更高的選擇性,同時保留了誘餌受體,從而為我們的抗體提供了明顯的差異化生物學特性。我們還證明,與其他 2 種臨床候選藥物相比,我們具有更大的效力。

  • And the last slide. So just to summarize, our key pipeline assets are on track and progressing quickly. Our anti-PD1-IL2 will enroll its first patient at the beginning of 2024, and our anti-TL1A program will read out its interim analysis in the second half of 2024. And as I noted, our anti-IL15 program is moving rapidly through Phase I, and we've initiated a proof of mechanism study this year in Celiac patients. Our olanzapine Phase III study, as I noted, is actually enrolling very quickly, and we hope to see that data readout in the first half of [2025].

    最後一張幻燈片。總而言之,我們的關鍵管道資產正在步入正軌並且進展迅速。我們的抗 PD1-IL2 項目將在 2024 年初招募第一位患者,我們的抗 TL1A 項目將在 2024 年下半年公佈其中期分析。正如我所指出的,我們的抗 IL15 項目正在快速進展第一階段,我們今年在乳糜瀉患者中啟動了機制研究證明。正如我所指出的,我們的奧氮平 III 期研究實際上正在很快入組,我們希望在 [2025] 上半年看到數據讀出。

  • And finally, we're initiating our ICS/SABA Phase III program next month with a readout focused on the second half of 2026. And with that, I'll hand it over to Eliyahu Kalif.

    最後,我們將於下個月啟動 ICS/SABA 第三階段計劃,重點關注 2026 年下半年。接下來,我將把它交給 Eliyahu Kalif。

  • Eliyahu Sharon Kalif - Executive VP & CFO

    Eliyahu Sharon Kalif - Executive VP & CFO

  • Thank you, Eric, and good morning and good afternoon to everyone. I'll begin my review of our Q2 2023 financial results with Slide #25, starting with our GAAP performance. Revenue in the second quarter of 2023 were $3.9 billion, representing an increase of 2% compared to Q2 2022.

    謝謝你,埃里克,祝大家早上好,下午好。我將從幻燈片 #25 開始回顧 2023 年第二季度的財務業績,首先是我們的 GAAP 表現。 2023年第二季度收入為39億美元,較2022年第二季度增長2%。

  • In local currency terms, revenue increased by 4%, and to provide you some color on our revenue performance by region. In North America, we had overall strong performance with 5% growth in Q2 2023 compared to the second quarter last year. This growth was mainly driven by higher revenue from certain innovative products, primarily AUSTEDO, and AJOVY as well as Anda our distribution business, which benefited from higher demand in secondary wholesaler markets.

    以當地貨幣計算,收入增長了 4%,並為您提供了我們按地區劃分的收入表現的一些信息。在北美,我們的整體業績表現強勁,與去年第二季度相比,2023 年第二季度增長了 5%。這一增長主要是由於某些創新產品(主要是 AUSTEDO 和 AJOVY 以及我們的分銷業務 Anda 的收入增加)推動的,這些產品受益於二級批發商市場的需求增加。

  • It was partially offset by lower revenue from our generic products and COPAXONE, BENDEKA and TREANDA. Revenues in our generics business in North America decreased by 6% in Q2 2023, mainly due to increase in competition to parts of our portfolio. The overall pricing environment in North America generic remained stable.

    我們的仿製藥產品以及 COPAXONE、BENDEKA 和 TREANDA 的收入下降部分抵消了這一影響。 2023 年第二季度,我們在北美的仿製藥業務收入下降了 6%,主要是由於我們部分產品組合的競爭加劇。北美仿製藥的整體定價環境保持穩定。

  • Revenues in Europe segment were flat in local currency terms. We continue to see solid growth in our generics business and from AJOVY in the second quarter. This was, however, largely offset by lower revenue from our legacy brands, including COPAXONE.

    以當地貨幣計算,歐洲部門的收入持平。我們繼續看到我們的仿製藥業務和 AJOVY 在第二季度的穩健增長。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。

  • And revenues from our International Markets segment increased by 13% in local currency terms this was mainly driven by higher revenue from generics products coming from price increases largely as a result of rising costs due to inflationary pressures. This increase was partially offset by regulatory price reductions and generate competition to off-patent products in Japan. GAAP operating loss was $646 million in the second quarter of 2023 compared to an operating loss of $949 million in the second quarter of 2022. The lower operating loss in the second quarter of 2023 was mainly due to higher legal settlements and goodwill impairment charges in the second quarter of 2023. We had a net loss of $863 million compared to the net loss of $232 million in Q2 2022.

    以當地貨幣計算,我們國際市場部門的收入增長了 13%,這主要是由於通貨膨脹壓力導致成本上漲而導致價格上漲,從而導致仿製藥產品收入增加。這一增長被監管降價以及對日本專利到期產品的競爭所部分抵消。 2023 年第二季度的GAAP 運營虧損為6.46 億美元,而2022 年第二季度的運營虧損為9.49 億美元。2023 年第二季度運營虧損較低,主要是由於法律和解和商譽減值費用增加。 2023 年第二季度。我們的淨虧損為 8.63 億美元,而 2022 年第二季度的淨虧損為 2.32 億美元。

  • And a GAAP loss per share of $0.77 compared to a GAAP loss per share of $0.21 in the same period a year ago. The higher net loss in the second quarter of 2023, mainly due to a lower tax benefit in Q2 2023 compared to Q2 2022. Due to effects of a portion of (inaudible) of losses related to an investment in one of our U.S. subsidiaries last year, partially offset by lower operating loss as discussed above.

    GAAP 每股虧損為 0.77 美元,而去年同期的 GAAP 每股虧損為 0.21 美元。 2023 年第二季度的淨虧損較高,主要是由於2023 年第二季度的稅收優惠低於2022 年第二季度。由於去年與我們一家美國子公司的投資相關的部分(聽不清)虧損的影響,部分被上面討論的較低的營業虧損所抵消。

  • Foreign exchange rate movements during the second quarter of 2023, including hedging effects negatively impacted our revenue and GAAP operating income by $51 million and $38 million, respectively, compared to the second quarter of 2022. This was primarily a result of an impact of a stronger U.S. dollar against the currencies of certain international markets in which we operate. Partially offset by the benefit of euro appreciation, approximately 46% of our revenue in Q2 2023 came from sales denominated in non-U.S. dollar currency.

    與2022 年第二季度相比,2023 年第二季度的匯率變動(包括對沖效應)對我們的收入和GAAP 營業收入分別產生了5100 萬美元和3800 萬美元的負面影響。這主要是由於匯率走強的影響所致。美元兌我們經營所在的某些國際市場的貨幣。 2023 年第二季度,我們約 46% 的收入來自以非美元貨幣計價的銷售,部分被歐元升值的好處所抵消。

  • Turning to Slide #26. You can see that the total non-GAAP adjustment in the second quarter of 2023 were approximately $1.5 billion compared to $986 million in Q2 2022. Notable non-GAAP adjustments included a goodwill impairment charge of $700 million related to our international markets reporting unit, mainly due to an increase in the discount rate due to higher risk associated with several countries.

    轉向幻燈片 #26。您可以看到,2023 年第二季度的非GAAP 調整總額約為15 億美元,而2022 年第二季度為9.86 億美元。值得注意的非GAAP 調整包括與我們的國際市場報告部門相關的7 億美元商譽減值費用,主要是由於與幾個國家相關的風險較高而導致貼現率增加。

  • As well as legal settlements and loss continuities expenses of $462 million, mainly related to estimated provisions recorded in connection with certain litigation cases in the U.S. including a $200 million provision related to the U.S. DOJ Criminal price fixing case based on advanced settlement discussions with the DOJ. Other notable adjustments include amortization of purchased intangible assets of $162 million, the majority of which is included in cost of sales.

    以及4.62 億美元的法律和解和損失連續性費用,主要與與美國某些訴訟案件相關的估計撥備有關,其中包括與美國司法部刑事定價案件相關的2 億美元撥備,該撥備基於與司法部的高級和解討論。其他值得注意的調整包括 1.62 億美元購買無形資產的攤銷,其中大部分包含在銷售成本中。

  • Now moving to Slide #27. For our review of our non-GAAP performance, as I mentioned, our second quarter revenue were totaled approximately $3.9 billion represented a growth of 4% in local currency terms compared to the second quarter of 2022. Now let's move down the P&L, starting with the gross profit margin. Our non-GAAP gross profit margin was 52.2% in the second quarter of 2023, compared to 64.4% in Q2 2022. This decrease in non-GAAP gross profit margin was mainly driven by higher cost of due -- with higher cost of due to inflationary pressures, FX and other macroeconomic elements. And increasing revenues with lower profitability from Anda in our North America segment and lower revenues from COPAXONE partially offset by higher revenues from AUSTEDO. As I mentioned last quarter, and as expected, this was an approximately 300 basis point sequential improvement in our non-GAAP gross profit margin in Q2 2023 compared to the first quarter of 2023.

    現在轉到幻燈片 #27。正如我所提到的,在我們對非GAAP 業績的回顧中,我們第二季度的收入總計約為39 億美元,以當地貨幣計算,與2022 年第二季度相比增長了4%。現在讓我們向下移動損益表,從毛利率。 2023 年第二季度,我們的非 GAAP 毛利率為 52.2%,而 2022 年第二季度為 64.4%。非 GAAP 毛利率的下降主要是由於應付成本上升所致。通脹壓力、外彙和其他宏觀經濟因素。北美業務 Anda 盈利能力下降以及 COPAXONE 收入下降導致收入增加,但 AUSTEDO 收入增加部分抵消了收入的增加。正如我上季度提到的,正如預期的那樣,與 2023 年第一季度相比,我們 2023 年第二季度的非 GAAP 毛利率環比提高了約 300 個基點。

  • This improvement was driven by an anticipated shift towards more balanced and normalized portfolio mix, mainly driven by strong growth in AUSTEDO growth in AJOVY as well as sequential improvement in our cost of goods sold due to the expected easing of the inflationary pressures and other measures that we are taking to drive our productivity in our supply chain.

    這一改善是由預期轉向更加平衡和標準化的投資組合組合推動的,這主要是由於 AJOVY 的 AUSTEDO 增長強勁增長,以及由於通脹壓力預期緩解和其他措施而導致我們的銷售成本連續改善。我們正在採取措施提高供應鏈的生產力。

  • Our non-GAAP operating margin in Q2 2023 was 26.1% versus 26.9% in Q2 2022. This decrease was mainly driven by lower gross profit margin, as I just mentioned, partially offset by a decrease in operating expenses. We ended the quarter with a non-GAAP earnings per share of $0.56 compared to $0.68 in Q2 2022, mainly due to higher financial expenses in Q2 2023 as well as the lower taxes in Q2 2022 due to the effect of higher tax benefits last year, as I mentioned earlier.

    我們2023 年第二季度的非公認會計原則營業利潤率為26.1%,而2022 年第二季度為26.9%。正如我剛才提到的,這一下降主要是由於毛利率下降造成的,但部分被營業費用的下降所抵消。截至本季度末,我們的非公認會計原則每股收益為0.56 美元,而2022 年第二季度為0.68 美元,這主要是由於2023 年第二季度財務費用增加,以及由於去年稅收優惠增加而導致2022年第二季度稅收降低,正如我之前提到的。

  • Now let's take a look at our spend base on Slide #28. As you can see, our quarterly spend base increased by $100 million or [$115 million] on a local currency basis. Most of this increase was due to a higher cost of goods sold related to higher revenues and the factors I just described earlier, partially offset by lower operating expenses.

    現在讓我們看一下幻燈片#28​​ 上的支出基礎。正如您所看到的,我們的季度支出基數增加了 1 億美元,按當地貨幣計算[1.15 億美元]。這一增長大部分是由於與收入增加以及我之前描述的因素相關的銷售商品成本上升,部分被運營費用下降所抵消。

  • As I highlighted last quarter, we continue to transform our global manufacturing and operating footprint. We have made significant progress over the last 5 years to consolidate our sites to get to more efficient going from 80 manufacturing sites down to 51 sites today and has 2 additional sites planned for closure or divestitures by the end of 2023.

    正如我上季度強調的那樣,我們繼續改變我們的全球製造和運營足跡。過去 5 年裡,我們在整合工廠以提高效率方面取得了重大進展,從 80 個製造工廠減少到如今的 51 個工廠,併計劃在 2023 年底之前關閉或剝離另外 2 個工廠。

  • Moving forward, we expect this optimization efforts to continue and reach a normalized size count between 40 to 44 sites over the near medium term to help drive efficiencies in our operations and improve margins.

    展望未來,我們預計這種優化工作將繼續下去,並在中期內達到 40 至 44 個站點之間的標準化規模數量,以幫助提高我們的運營效率並提高利潤率。

  • Turning to free cash flow on Slide #29. (inaudible) as part of our cash flow, commercial relationship management activities to permit decisions in our commercial and supply chain activities, which may drive an acceleration of receivable payments from customers or the acceleration of payments to vendors in our efforts to continually seek to improve the efficiencies of our working capital management will obtain more favorable payment terms of many of our vendors, which are expected to continue in future periods.

    轉向幻燈片#29 上的自由現金流。 (聽不清)作為我們現金流的一部分,商業關係管理活動允許我們在商業和供應鏈活動中做出決策,這可能會加速客戶的應收付款或加速向供應商付款,以不斷尋求改進我們的營運資金管理效率將使我們的許多供應商獲得更優惠的付款條件,預計這種情況將在未來持續下去。

  • Our free cash flow in the second quarter of 2023 was $632 million compared to $301 million in Q2 2022. The increase in free cash flow in the second quarter of 2023 resulted mainly from changes in working capital items, including positive impact from accounts receivable, net of SR&A and from inventory levels, partially offset by a negative impact of accounts payable as well as higher proceeds from sales of business and long-lived assets.

    我們2023 年第二季度的自由現金流為6.32 億美元,而2022 年第二季度為3.01 億美元。2023 年第二季度自由現金流的增加主要是由於營運資本項目的變化,包括應收賬款、淨額的積極影響SR&A 和庫存水平的影響,部分被應付賬款的負面影響以及業務和長期資產銷售收入的增加所抵消。

  • Today, we are reaffirming our 2023 free cash flow guidance, which we provided in February, our 2023 free cash flow is expected to be in the range of $1.7 billion to $2.1 billion. We expect our free cash flow to continue to progress in the second half of this year as we had a gradual ramp-up in our profitability and continue to drive working capital improvements.

    今天,我們重申我們在 2 月份提供的 2023 年自由現金流指引,我們的 2023 年自由現金流預計在 17 億美元至 21 億美元之間。我們預計今年下半年我們的自由現金流將繼續增長,因為我們的盈利能力逐步提高,並繼續推動營運資本的改善。

  • Turning to Slide #30. Our net debt at the end of Q2 2023 was $18 billion, compared to $18.4 billion at the end of 2022. Our gross debt was $20.7 billion compared to $21.2 billion at the end of 2022. The decrease in our gross debt was mainly due to $646 million senior notes repaid at maturity that was due on March 31, partially offset by exchange rate fluctuations of $156 million.

    轉向幻燈片#30。截至 2023 年第二季度末,我們的淨債務為 180 億美元,而 2022 年底為 184 億美元。我們的總債務為 207 億美元,而 2022 年底為 212 億美元。總債務減少主要是由於 646 美元3 月31 日到期的100 萬美元高級票據已到期償還,部分被1.56 億美元的匯率波動所抵消。

  • Subsequent to the second quarter close, we withdraw a total amount of $700 million under our $1.8 billion revolving credit facility, the proceeds which were used to repay $1 billion of our senior notes at maturity on July 21. Our net debt to EBITDA improved compared to Q1 2023 coming in at 4.14x for Q2 2023. Mainly due to a free cash flow generation in the second quarter, partially offset by movements in foreign exchange rates.

    第二季度結束後,我們根據18 億美元的循環信貸額度提取了總計7 億美元的資金,所得款項用於償還7 月21 日到期的10 億美元優先票據。與EBITDA 相比,我們的淨債務有所改善。 2023 年第一季度的增長率為 2023 年第二季度的 4.14 倍。主要是由於第二季度自由現金流的產生,部分被外匯匯率變動所抵消。

  • Debt reduction continues to be our focus and we expect to continue to work towards our long-term financial target of being 2x net to EBITDA by the end of 2027.

    債務削減仍然是我們的重點,我們預計將繼續努力實現我們的長期財務目標,即到 2027 年底實現 EBITDA 淨值的 2 倍。

  • Turning to Slide #31, which represents our upcoming debt maturities. If you recall, we successfully refinanced approximately $2.5 billion of our debt through sustainability-linked senior notes during the first quarter of 2023. With an objective to align our near-term debt maturities with our free cash flow guidance for this year.

    轉向幻燈片 #31,它代表我們即將到期的債務。如果您還記得的話,我們在2023 年第一季度通過與可持續發展相關的高級票據成功為約25 億美元的債務進行了再融資。目標是使我們的近期債務到期日與今年的自由現金流指導保持一致。

  • With our ongoing cash flow generation, we believe we are well-positioned to continue to service our debt and meet these upcoming maturities. As I mentioned earlier, in July 2023, we repaid $1 billion of our 2.8% senior notes at maturity, so there is no additional maturity payments due in 2023.

    隨著我們持續產生現金流,我們相信我們有能力繼續償還債務並滿足即將到來的到期日。正如我之前提到的,2023 年 7 月,我們償還了 10 億美元的 2.8% 優先票據,因此 2023 年沒有額外的到期付款。

  • Now turning to our 2023 non-GAAP outlook on Slide #32. As Richard highlighted earlier, and as I reflected in the first half of -- as we reflect in the first half of this year, we have made a solid progress in terms of our revenues, while we continue to navigate gradual improvement in our margin.

    現在轉向幻燈片#32 上的 2023 年非 GAAP 展望。正如理查德早些時候強調的那樣,正如我在上半年所反映的那樣,正如我們在今年上半年所反映的那樣,我們在收入方面取得了堅實的進展,同時我們的利潤率繼續逐步提高。

  • This includes solid momentum in our key growth engines, especially AUSTEDO, the launch of UZEDY, continued growth in AJOVY and a solid performance in our generics business, especially in Europe and international markets. In addition, since we provided our initial guidance range in February this year, we are seeing a relatively higher demand in certain businesses, including our distribution business in Anda, which benefited in the first half of this year from higher demand in the secondary wholesaler market, the generics business in our Europe and International Markets segment and as well as relatively favorable foreign exchange rate environment.

    這包括我們關鍵增長引擎的強勁動力,特別是 AUSTEDO、UZEDY 的推出、AJOVY 的持續增長以及我們的仿製藥業務的穩健表現,尤其是在歐洲和國際市場。此外,自從我們在今年2月份提供了初步指導範圍以來,我們看到某些業務的需求相對較高,包括我們在安達的分銷業務,該業務今年上半年受益於二級批發商市場的較高需求、歐洲和國際市場部門的仿製藥業務以及相對有利的匯率環境。

  • Therefore, to reflect our revenue performance in the first half, along with expected continued development in the second half of 2023, we're increasing the lower end of our full year revenue guidance range by $200 million. We now expected our revenue to be between $15 billion and $15.4 billion for the full year of 2023.

    因此,為了反映我們上半年的收入表現以及 2023 年下半年的預期持續發展,我們將全年收入指導範圍的下限增加了 2 億美元。我們現在預計 2023 年全年的收入將在 150 億美元至 154 億美元之間。

  • We are also reaffirming our 2023 non-GAAP outlook for operating income, EBITDA, earnings per share and free cash flow, as provided in February. As I mentioned during the first quarter earnings call and in line with the subsequent improvement that we actually saw in the second quarter of 2023, we continue to expect a gradual improvement in our margin in the second half of the year.

    我們還重申了 2 月份提供的 2023 年非公認會計原則營業收入、EBITDA、每股收益和自由現金流的展望。正如我在第一季度財報電話會議上提到的,根據我們在 2023 年第二季度實際看到的後續改善,我們繼續預計下半年利潤率將逐步改善。

  • We believe this will be driven by further improvement in our cost of goods sold as we navigated the impact of the inflationary pressures that we saw in the second half of the year and drive improvements in our operating expenses as well as by changes in our portfolio mix with a further ramp up in revenue from our key growth drivers, including AUSTEDO.

    我們相信,這將受到我們的銷售成本進一步改善的推動,因為我們克服了下半年通脹壓力的影響,並推動了我們的運營支出的改善以及我們的投資組合的變化我們的主要增長動力(包括AUSTEDO )帶來的收入進一步增加。

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

    至此,我對 Teva 2023 年第二季度業績的回顧就結束了。現在我將其交還給理查德進行總結。

  • Richard D. Francis - President, CEO & Director

    Richard D. Francis - President, CEO & Director

  • Thank you, Ali, and thank you, Eric. So in summary, as I say, earlier a solid Q2 performance-wise driven by our growth drivers of AUSTEDO, UZEDY and AJOVY.

    謝謝你,阿里,謝謝你,埃里克。總而言之,正如我所說,在 AUSTEDO、UZEDY 和 AJOVY 增長動力的推動下,第二季度業績表現強勁。

  • Good stable business from our generics portfolio we've talked about up in the guidance, which we're pleased about, and we made tangible progress on our pivot to growth strategy to get us back to long-term growth. So with that, I'll hand it back to (inaudible) to take some questions. Thank you for your time.

    我們在指南中談到了我們的仿製藥產品組合的良好穩定業務,我們對此感到高興,並且我們在轉向增長戰略以恢復長期增長方面取得了切實進展。因此,我將把它交還給(聽不清)回答一些問題。感謝您的時間。

  • Operator

    Operator

  • (Operator Instructions) Our first question for today comes from Jason Gerberry of Bank of America. Please go ahead.

    (操作員說明)我們今天的第一個問題來自美國銀行的 Jason Gerberry。請繼續。

  • Jason Matthew Gerberry - MD in US Equity Research

    Jason Matthew Gerberry - MD in US Equity Research

  • I guess just curious, with AUSTEDO and the growth ambitions that you've laid out, I'm wondering if you could identify like sort of the singular biggest driver to this undertreatment dynamic. Do you think that these patients are sitting in psychiatrist office and just haven't been made aware or just choosing not to get treatment or do you think that maybe the population is just more dispersed and it's just going to require more of a larger field force to get the word out around these therapies?

    我想只是好奇,通過 AUSTEDO 和你所闡述的增長雄心,我想知道你是否能找出這種治療不足動態的單一最大驅動因素。您是否認為這些患者坐在精神科醫生的辦公室裡,只是沒有被告知或只是選擇不接受治療,或者您認為也許人口更加分散,只是需要更多的現場工作人員來宣傳這些療法?

  • And then maybe, Richard, just curious, there's a lot of media reports about API and the TL1A assets being explored as potential divestiture candidates. Wondering if you could add any color to that topic and willingness to part ways with either of those.

    理查德,也許只是好奇,有很多關於 API 和 TL1A 資產的媒體報導正在探索作為潛在的剝離候選者。想知道您是否可以為該主題添加任何色彩,並願意與其中任何一個分道揚鑣。

  • Richard D. Francis - President, CEO & Director

    Richard D. Francis - President, CEO & Director

  • Thanks, Jason. Thanks for your question. I'll answer both, but also can maybe spend an opportunity to comment. On the patients -- the untreated patients for tardive dyskinesia, it's a bit of all of what you said actually. There are patients sitting in the office that don't get diagnosed from the psychiatrists. And some of that could be quite simple that the symptoms of tardive dyskinesia that they aren't visible to the physician and the physician has to explore them. So that's one. Another part is they actually don't make their way into the physician's office to seek actual treatment.

    謝謝,傑森。謝謝你的提問。我會同時回答這兩個問題,但也許也可以花一個機會發表評論。對於那些未經治療的遲發性運動障礙患者,這實際上是你所說的一部分。有些坐在辦公室裡的病人沒有得到精神科醫生的診斷。其中一些可能非常簡單,即遲發性運動障礙的症狀對醫生來說是不可見的,而醫生必須探索它們。這就是其中之一。另一部分是他們實際上並沒有進入醫生辦公室尋求實際治療。

  • And we see that because when we do direct-to-consumer programs, we see a significant influx of patients into physicians' office. So I think what our process going forward is to make sure we constantly educate physicians about identifying these patients and asking them the right questions. And I think we're seeing a good traction on that.

    我們看到這一點是因為當我們開展直接面向消費者的計劃時,我們看到大量患者湧入醫生辦公室。因此,我認為我們接下來的流程是確保我們不斷地教育醫生如何識別這些患者並向他們詢問正確的問題。我認為我們在這方面看到了良好的勢頭。

  • And the second is to make sure patients actually enter the physician's office, to ask questions about some of the symptoms they have. So then as a journey. I think we're making good progress. Now moving on to API TL1A.

    第二是確保患者真正進入醫生的辦公室,詢問他們的一些症狀。那麼作為一個旅程。我認為我們正在取得良好進展。現在轉向 API TL1A。

  • Look, as we said with regard to our TAPI business, we set it up as a stand-alone business because we see -- if we focus this is we have ability to drive top line growth, which will help us on our pivotal growth strategy.

    看,正如我們在談到TAPI 業務時所說的那樣,我們將其設置為一項獨立業務,因為我們看到,如果我們專注於此,我們就有能力推動營收增長,這將有助於我們實現關鍵增長戰略。

  • If we started the progress on that, and that's going very well. And we remain committed to that. I think the attraction there and the discussion that's been talked about outside, I think nearly highlights how I think attractive this business is. and how the right focus it can perform. When it comes to the TL1A, as I've said on a number of calls, we are committed to this asset.

    如果我們開始在這方面取得進展,那麼進展會非常順利。我們仍然致力於這一點。我認為那裡的吸引力以及外界談論的討論幾乎凸顯了我認為這個行業的吸引力。以及它如何實現正確的聚焦。當談到 TL1A 時,正如我在多次電話會議中所說的那樣,我們致力於這一資產。

  • We fully funded it through its clinical development. I'm very excited about it. We do, as Eric highlighted, we believe we have a differentiated best-in-class. But obviously, it's a hot topic. So everybody is talking about TL1A, and in particular, I think ours gets (inaudible) to be low. But our aim is to once again develop that asset and use that as another lever to get ourselves back to growth. It will be one of those things that drive growth in [2018] and beyond. So thanks for your questions. Do you like to add anything else to that?

    我們通過其臨床開發為其提供了全額資助。我對此感到非常興奮。正如埃里克所強調的那樣,我們相信我們擁有差異化的同類最佳產品。但顯然,這是一個熱門話題。所以每個人都在談論 TL1A,特別是,我認為我們的(聽不清)很低。但我們的目標是再次開發該資產,並將其用作使我們恢復增長的另一個槓桿。這將是推動 [2018] 年及以後增長的因素之一。謝謝你的提問。您還想添加其他內容嗎?

  • Sven Dethlefs - EVP of North America Commercial

    Sven Dethlefs - EVP of North America Commercial

  • I think you covered it well, what I may want to add is that we already saw in the last years a significant expansion of the prescriber base for tardive dyskinesia. Please keep in mind that these patients have multiple diseases that have a mental health condition that is already difficult to treat the tardive dyskinesia, and then needs to be recognized by physicians.

    我認為你講得很好,我可能想補充的是,過去幾年我們已經看到遲發性運動障礙的處方者基礎顯著擴大。請記住,這些患者患有多種疾病,有心理健康問題,遲發性運動障礙已經很難治療,需要得到醫生的認可。

  • It is, of course, with VMAT-2 inhibitors very well treatable and we have seen that physicians that started to treat tardive dyskinesia also are able to identify more patients for that reason we believe we can tap into this enormous patient potential in helping more patients in the future. And then other factors that are particularly contributing to our growth is, of course, now the availability of the once-daily formulation because we couldn't participate in the market segment, which is very much focused also on patient convenience, and we are quite happy now that we can address that market segment as well.

    當然,使用VMAT-2 抑製劑可以很好地治療這種情況,我們已經看到開始治療遲發性運動障礙的醫生也能夠識別更多患者,因此我們相信我們可以挖掘患者的巨大潛力來幫助更多患者將來。當然,特別有助於我們增長的其他因素是現在每日一次配方的可用性,因為我們無法參與這個市場領域,該市場也非常注重患者的便利性,而且我們非常關注現在很高興我們也可以解決這個細分市場。

  • So it will contribute to our growth, in particular.

    因此,它將特別有助於我們的成長。

  • Operator

    Operator

  • Our next question comes from Umer Raffat of Evercore ISI.

    我們的下一個問題來自 Evercore ISI 的 Umer Raffat。

  • Umer Raffat - Senior MD & Senior Analyst of Equity Research

    Umer Raffat - Senior MD & Senior Analyst of Equity Research

  • I think 2026 was a date you mentioned on slides regarding a possible EU entry that you're investigating. My question is, considering the U.S. approval was on a 505(b)(2) basis. There has to be an additional trial and I'm curious what specific feedback or any early feedback (inaudible) is sharing on that note?

    我認為 2026 年是您在幻燈片中提到的有關您正在調查的可能加入歐盟的日期。我的問題是,考慮到美國的批准是基於 505(b)(2) 的基礎上。必須進行額外的試驗,我很好奇在該說明上分享了哪些具體反饋或任何早期反饋(聽不清)?

  • Secondly, it looks like EBITDA for the full year, as much as it's tracking ahead of consensus so far. It's not quite annualizing at what the low end of the full year guidance is and even versus first half last year, it's slightly lower, partially because of the gross margin first quarter. But to get to above 4.5% last year, in EBITDA, there was a onetime charge called other non-GAAP of $200 million, which kind of enabled the full year to get to just about $4.5 billion.

    其次,它看起來像是全年的 EBITDA,儘管到目前為止它已經超出了共識。它並沒有完全按全年指導的低端進行年化,即使與去年上半年相比,也略有下降,部分原因是第一季度的毛利率。但為了去年 EBITDA 達到 4.5% 以上,需要一次性收取 2 億美元的其他非 GAAP 費用,這使得全年的 EBITDA 達到約 45 億美元。

  • And I'm curious, are you modeling some sort of other non-GAAP charge to enable getting to about $4.5 billion EBITDA this year?

    我很好奇,您是否正在對某種其他非 GAAP 費用進行建模,以使今年的 EBITDA 達到約 45 億美元?

  • Richard D. Francis - President, CEO & Director

    Richard D. Francis - President, CEO & Director

  • Thanks for the questions. So yes, we've made a lot of progress on AUSTEDO and making sure tardive dyskinesia and Huntington's disease patients can benefit from that in Europe and on the particular timings in the past, I'll hand that over to Eric.

    感謝您的提問。所以,是的,我們在 AUSTEDO 方面取得了很大進展,並確保遲發性運動障礙和亨廷頓病患者能夠在歐洲和過去的特定時間中受益,我會將其交給 Eric。

  • Eric A. Hughes - Executive VP of Global R&D and Chief Medical Officer

    Eric A. Hughes - Executive VP of Global R&D and Chief Medical Officer

  • Thank you, Umer. So we are working on the package for the EU with AUSTEDO. The requirements are, we believe sufficient with the data we have to date. That's an ongoing discussion with the health authorities. I'll be working on that through the following year.

    謝謝你,烏梅爾。因此,我們正在與 AUSTEDO 一起制定針對歐盟的一攬子計劃。我們認為,根據我們迄今為止掌握的數據,這些要求已經足夠了。這是與衛生當局的持續討論。我將在接下來的一年裡致力於此。

  • Umer Raffat - Senior MD & Senior Analyst of Equity Research

    Umer Raffat - Senior MD & Senior Analyst of Equity Research

  • Thanks, Eric. And then, Eliyahu, do you want to touch on some of the questions on the EBITDA?

    謝謝,埃里克。然後,Eliyahu,您想談談有關 EBITDA 的一些問題嗎?

  • Eliyahu Sharon Kalif - Executive VP & CFO

    Eliyahu Sharon Kalif - Executive VP & CFO

  • Yes, for sure. Umer. Thank you for your question. I think, first, we are not considering any non-GAAP adjustment for the second half in order to make sure that we are actually lending the $4.5 billion, $4.6 billion EBITDA that we are expecting. But I will mention that the second half would be more accretive in terms of gross margin that will flow to the EBITDA line.

    是肯定的。烏默爾。謝謝你的問題。我認為,首先,我們不會考慮下半年進行任何非 GAAP 調整,以確保我們實際放貸達到我們預期的 45 億美元、46 億美元 EBITDA。但我要提到的是,下半年的毛利率將會更多地增加,並將流入 EBITDA 線。

  • And this is mostly due to the mix. And the fact that we actually now narrow the guidance on the top line that gets us kind of a case to be at the midpoint just for the modeling of 15.2%. And other than that, we are also not making on too much on FX. The rebounding we're using the same average of FX for the first half.

    這主要是由於混合造成的。事實上,我們現在實際上縮小了頂線的指導範圍,這讓我們在 15.2% 的建模中處於中點。除此之外,我們在外匯方面也沒有賺到太多錢。我們使用與上半年相同的外匯平均值來計算反彈。

  • Operator

    Operator

  • Our next question comes from Balaji Prasad from Barclays. Please go ahead.

    我們的下一個問題來自巴克萊銀行的巴拉吉·普拉薩德。請繼續。

  • Unidentified Analyst

    Unidentified Analyst

  • This is Mike on for Balaji. Just 2 from me. What does Teva aims to achieve with more control on the biosimilar facility? And if you could just provide some more color on what you've seen until now. And then my other one is just on the pricing stabilization that you mentioned, was generic pricing in the U.S. stable quarter-over-quarter or year-over-year?

    這是巴拉吉的邁克。就我2個。梯瓦(Teva)希望通過對生物仿製藥設施進行更多控制來實現什麼目標?如果你能就你到目前為止所看到的內容提供更多的色彩的話。然後我的另一個問題是關於您提到的定價穩定,美國的仿製藥定價季度環比或同比穩定嗎?

  • Richard D. Francis - President, CEO & Director

    Richard D. Francis - President, CEO & Director

  • So look, I'll start [on that], and I'll hand over to Sven. I think, look, on the Alvotech partnership, I think we what we mean by operational involvement is -- it means that when it comes to the manufacturing and the quality aspects, obviously, we cover with 50-plus sites, we have a wealth of experience in this area. And so we're actually having people on the ground of working with Alvotech to help them obviously in the areas that have been identified by the FDA. So that is something which we set up. We even have a committee setup, so it's formalized the [JSE]. So I think that's well-structured and Alvotech very excited about the help they're getting from us. When it comes to the generic pricing, I'll have that to Sven to talk about that from the quarter to yearly.

    所以聽著,我將開始[就此],然後將任務交給斯文。我認為,看,關於Alvotech 合作夥伴關係,我認為我們所說的運營參與是指——這意味著,當涉及到製造和質量方面時,顯然,我們覆蓋了50 多個站點,我們擁有豐富的資源的該領域的經驗。因此,我們實際上有人與 Alvotech 合作,在 FDA 確定的領域為他們提供幫助。這就是我們設立的。我們甚至設立了一個委員會,因此它正式化了 [JSE]。所以我認為這是一個很好的結構,Alvotech 對我們提供的幫助感到非常興奮。當談到通用定價時,我將讓斯文從季度到每年討論這個問題。

  • Sven Dethlefs - EVP of North America Commercial

    Sven Dethlefs - EVP of North America Commercial

  • Yes. Thank you for the question. So the U.S. generics price decline has indeed slowed down over the last quarters. If you look at the pure core generics business that Teva has in the U.S., we actually had 6 very stable quarters now, which was also supported by the slowdown price decline. It's not driven by a change in price bidding on the side of wholesalers or on the side of buying groups that did not change in the last quarters. What we've seen is that, of course, generics are built on supply and demand.

    是的。感謝你的提問。因此,過去幾個季度美國仿製藥價格下降速度確實有所放緩。如果你看看 Teva 在美國的純核心仿製藥業務,我們現在實際上有 6 個非常穩定的季度,這也受到價格下跌放緩的支撐。這並不是由批發商或購買集團方面的競價變化驅動的,而這些變化在過去幾個季度中沒有發生變化。當然,我們所看到的是,仿製藥是建立在供給和需求之上的。

  • And since we see more supply chain disruptions or supply discontinuities also on behalf of our competitors. It helps slow down the price erosion and what we also noticed is that not only Teva, but also other companies are looking into portfolio consolidation. And if you do that, typically, it supports the price decline slowdown and then we've seen not too many large generic launches, which is the third factor, typically the pricing influence and price decline.

    因為我們看到更多的供應鏈中斷或供應中斷也代表我們的競爭對手。它有助於減緩價格侵蝕,我們還注意到,不僅梯瓦(Teva),其他公司也在考慮投資組合整合。如果你這樣做,通常會支持價格下降放緩,然後我們就不會看到太多大型仿製藥上市,這是第三個因素,通常是定價影響和價格下降。

  • And for that reason, we overall see a stable situation at the moment, and we have to see if this continues over the next quarter. So far, we have no indication for a change.

    因此,我們目前總體上看到了穩定的情況,我們必須看看這種情況是否會在下個季度持續下去。到目前為止,我們沒有任何改變的跡象。

  • Operator

    Operator

  • Our next question comes from Ash Verma of UBS ahead.

    我們的下一個問題來自瑞銀集團的 Ash Verma。

  • Ashwani Verma - Director of Americas Equity Research & US Specialty Pharma Analyst

    Ashwani Verma - Director of Americas Equity Research & US Specialty Pharma Analyst

  • I have to -- so on AUSTEDO, so XR is a nice step to kind of minimize the gap between you and the other key competitors is titration something that you can simplify as well in the near-term, investing (inaudible) further?

    我必須——所以在AUSTEDO 上,XR 是一個很好的步驟,可以最大限度地縮小你和其他主要競爭對手之間的差距,滴定是你可以在短期內簡化的事情,進一步投資(聽不清)?

  • And then second one, just on generic Symbicort. I think there was settlement that you had with AstraZeneca on that and can (inaudible) launch trigger acceleration of your market entry as per your settlement terms.

    然後是第二個,只是通用的 Symbicort。我認為您與阿斯利康就此達成了和解,並且可以(聽不清)根據您的和解條款啟動觸發加速您的市場進入。

  • Richard D. Francis - President, CEO & Director

    Richard D. Francis - President, CEO & Director

  • Thanks, Ash. Thanks for your question. So I'll start with the AUSTEDO and then I'll hand over to Sven for Symbicort. So you're right to highlight that titration is important for AUSTEDO as to make sure the patients end up on the efficacious dose. What we have done, and actually, it's occurred this month in August is we have continued to approve our titration offering with a titration pack that can be prescribed by the physician.

    謝謝,阿什。謝謝你的提問。因此,我將從 AUSTEDO 開始,然後將 Symbicort 交給 Sven。因此,您強調滴定對於 AUSTEDO 很重要,可以確保患者最終獲得有效劑量,這是正確的。事實上,我們所做的,實際上是在八月份,我們繼續批准我們的滴定產品,包括可以由醫生開處方的滴定包。

  • So it just makes it simple. It doesn't rely on the sample have to be left in the physician's office. So I think that's going to help the patient go through that titration to end up on the optimal dose for them from an efficacy point of view. So we just see that as another one of the offerings that were laid on to AUSTEDO that go with many others.

    所以它只是讓事情變得簡單。它不依賴於樣本必須留在醫生的辦公室。因此,我認為這將幫助患者完成滴定,從療效的角度最終獲得最佳劑量。因此,我們只是將其視為 AUSTEDO 提供的另一項產品,與許多其他產品一起提供。

  • Which is going back to what I said about the investment we're putting into AUSTEDO is across multichannel, different areas, and that's why we have confidence in hitting the $2.5 billion in 2027 but on the Symbicort, if I can hand that to you, Sven.

    回到我所說的,我們對 AUSTEDO 的投資是跨渠道、不同領域的,這就是為什麼我們有信心在 2027 年達到 25 億美元,但在 Symbicort 上,如果我可以把這個投資給你的話,斯文.

  • Sven Dethlefs - EVP of North America Commercial

    Sven Dethlefs - EVP of North America Commercial

  • Yes. Maybe in also to AUSTEDO that we eliminated the 6-milligram titration step. So that has already been simplified, and we are working on a more simplified titration schedule. Also what we do this month in August, we launched a titration package, a blister package that can be prescribed by physicians to initiate patients, so that will also help with effective titration.

    是的。也許在 AUSTEDO 中,我們取消了 6 毫克滴定步驟。所以這已經被簡化了,我們正在研究一個更簡化的滴定方案。另外,我們在八月份所做的事情是,我們推出了滴定套餐,這是一種泡罩包裝,可以由醫生開處方來啟動患者,因此這也將有助於有效滴定。

  • On generic Symbicort, we are working on this complex development. It's an inhaler. It's a combination inhaler. The FDA, of course, has hurdles to get these products approved for that reason. Our expectation is that this launch will be more driven by a probability of the product itself than any other considerations.

    對於仿製藥 Symbicort,我們正在致力於這一複雜的開發。這是一個吸入器。這是一個組合吸入器。當然,由於這個原因,FDA 在批准這些產品方面存在障礙。我們的預期是,此次發布將更多地受到產品本身的可能性驅動,而不是任何其他考慮因素。

  • Operator

    Operator

  • Our next question comes from Thibault Boutherin of Morgan Stanley.

    我們的下一個問題來自摩根士丹利的蒂博·布瑟林。

  • Thibault Boutherin - Equity Analyst

    Thibault Boutherin - Equity Analyst

  • I had some technical difficulties. So I apologize if it has already been asked. But my first question is on biosimilar Humira. It now seems that you will enter the market most likely in 2024 after most of your competitors have already launched. So what opportunity do you believe this biosimilar still represents could it still be a meaningful contributor to your revenues next year?

    我遇到了一些技術困難。因此,如果已經被問過,我深表歉意。但我的第一個問題是關於生物仿製藥 Humira。現在看來,在大多數競爭對手已經推出之後,您最有可能在 2024 年進入市場。那麼,您認為這種生物仿製藥仍然代表著什麼機會,它是否仍能為您明年的收入做出有意義的貢獻?

  • Or should we be conservative and assume that it will be challenging to compete in this market with the late entry. And if you do think that it's a meaningful opportunity, if you could highlight the factors that would enable you to compete despite being a little bit late to the market.

    或者我們應該保守一點,假設進入較晚的市場將難以競爭。如果你確實認為這是一個有意義的機會,如果你能強調那些能讓你在進入市場有點晚的情況下參與競爭的因素。

  • Second question on UZEDY, just if you could give us an update on coverage in the U.S. and the position of [formularies] compared to your key competitors in the injectable schizophrenia field.

    關於 UZEDY 的第二個問題,您能否向我們介紹一下美國的覆蓋範圍的最新情況以及與您在註射型精神分裂症領域的主要競爭對手相比的[處方集]的地位。

  • Richard D. Francis - President, CEO & Director

    Richard D. Francis - President, CEO & Director

  • I hand back this question to Sven. I think before I do, when we think about Humira, just to sort of outline, I think this is an evolving market so I think it's going to be interesting to see how 2023 plays out. And it's important to also understand the product profile that we have the final Alvotech is, I think, highly differentiated based on interchangeability the quality of (inaudible) maybe Sven, you can add a bit more depth to that.

    我把這個問題交給斯文。我想在此之前,當我們考慮 Humira 時,我認為這是一個不斷發展的市場,所以我認為看看 2023 年的表現將會很有趣。我認為,了解我們最終的 Alvotech 的產品概況也很重要,它基於可互換性(聽不清)的質量而高度差異化,也許 Sven,您可以對此添加更多的深度。

  • Sven Dethlefs - EVP of North America Commercial

    Sven Dethlefs - EVP of North America Commercial

  • Yes. Of course, we have seen now that on July 1, we had the market formation for biosimilars in the U.S. with several companies entering the market so far, but it's very early. There's only been a slower uptake of biosimilars versus the originator [API].

    是的。當然,我們現在已經看到,7月1日,美國生物仿製藥市場已經形成,目前已有幾家公司進入該市場,但現在還為時過早。與原研藥 [API] 相比,生物仿製藥的使用速度較慢。

  • What we expect is that we have in 2024 more decisions coming up on the side of PBM about formulary changes or eventually also hard changes to the formulary taking the originator out of the programs. So we have to work with Alvotech now on the FDA approval for a drug that's the prerequisite for us to enter the market.

    我們預計,到 2024 年,PBM 方面會做出更多關於處方變更的決定,或者最終對處方進行硬性變更,將發起人從項目中剔除。因此,我們現在必須與 Alvotech 合作,讓 FDA 批准一種藥物,這是我們進入市場的先決條件。

  • But we believe there's still an opportunity to be captured also in 2024 because we always said there is a 2-phase market formation, now 1 in July and 1 coming more with the natural formulary changes in January 2024. And then we will see how our very comprehensive product profile will work out. But overall, currently, our focus is on the FDA approval of the Alvotech site in Iceland.

    但我們相信2024 年仍然有機會抓住,因為我們總是說有一個2 階段的市場形成,現在7 月有1 階段,隨著2024 年1 月的自然配方變化,還會有1 階段。然後我們將看到我們的市場如何形成將會產生非常全面的產品簡介。但總體而言,目前我們的重點是 FDA 對 Alvotech 冰島工廠的批准。

  • And I think you asked the second question about UZEDY and the market average. So we are working, of course, with the target on parity position in all the payer plans. The majority of paid positions -- patients, sorry, comes from Medicare and Medicaid.

    我認為您問了關於 UZEDY 和市場平均水平的第二個問題。當然,我們正在努力實現所有付款計劃中平等地位的目標。大多數帶薪職位——對不起,患者來自醫療保險和醫療補助。

  • They have longer decision timelines than in the commercial segment, but we are making very good progress here in our market access discussions, we are actually right on plan or slightly ahead of our market access strategy targets. And we are very happy with the launch, how it's progressing.

    他們的決策時間表比商業領域更長,但我們在市場准入討論中取得了非常好的進展,我們實際上正在按計劃進行或稍微領先於我們的市場准入戰略目標。我們對發布及其進展情況感到非常滿意。

  • We've seen so far if you get a prescription for UZEDY, about 80% are filled also, and we have a very high interest on the hospital side for the free sampling program, that's an important segment for us as well because many patients are initiated on that side. So overall, I would say our launch is right on target and progressing well.

    到目前為止,我們已經看到,如果您獲得UZEDY 的處方,大約80% 也已配藥,而且我們醫院方面對免費採樣計劃非常感興趣,這對我們來說也是一個重要的部分,因為許多患者都在在那一邊發起。總的來說,我想說我們的發布是正確的目標並且進展順利。

  • Operator

    Operator

  • 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。

  • David A. Amsellem - MD & Senior Research Analyst

    David A. Amsellem - MD & Senior Research Analyst

  • So I had a couple of high-level questions about the neuropsychiatry business. Can you talk about your willingness or the wherewithal to bring in pipeline assets or even smaller scale commercial stage assets where you can leverage the commercial infrastructure that you have in place for AUSTEDO.

    所以我有幾個關於神經精神病學業務的高級問題。您能否談談您引入管道資產甚至更小規模商業階段資產的意願或資金,您可以在這些資產中利用 AUSTEDO 現有的商業基礎設施。

  • So just talk about your psychiatry focus in terms of BD M&A and what you can and can't do. And then secondly, just a broader strategic question. Do you think that there is a possibility or does it make sense to potentially explore a separation of the neuropsych business into a stand-alone business as a means of unlocking value, just given where AUSTEDO is and how the broader markets think of businesses with novel CNS assets?

    因此,請談談您在 BD 併購方面的精神病學重點以及您可以做什麼和不能做什麼。其次,這是一個更廣泛的戰略問題。鑑於 AUSTEDO 的現狀以及更廣泛的市場如何看待具有新穎性的業務,您認為探索將神經心理學業務分離為獨立業務作為釋放價值的手段是否有可能或有意義嗎?中樞神經系統資產?

  • Richard D. Francis - President, CEO & Director

    Richard D. Francis - President, CEO & Director

  • Thank you for those questions, David. So in answer to your first question, yes, I think we've started to build a real franchise with the psychiatric community. And actually, where we're at the recent conference, American Conference of Psychiatry, we actually said you are now the company in this area.

    謝謝你提出這些問題,大衛。因此,在回答你的第一個問題時,是的,我認為我們已經開始與精神病學界建立真正的特許經營權。事實上,在我們最近舉行的美國精神病學會議上,我們實際上說你們現在是這個領域的公司。

  • Obviously, they see that with AUSTEDO, they see that with UZEDY and obviously, olanzapine that Eric spoke about. So yes, and we are actively out there looking at median opportunities. Some of those about in-license seat and some of these are constrained a bit by our balance sheet and where we are right now.

    顯然,他們在 AUSTEDO 上看到了這一點,在 UZEDY 上看到了這一點,顯然,還有埃里克談到的奧氮平。所以是的,我們正在積極尋找中等機會。其中一些與許可席位有關,其中一些受到我們的資產負債表和目前狀況的限制。

  • But the advantage we have is we have an infrastructure that we can bring a plug-and-play products into. So I think for us, it is beneficial and it can be cost effective. And for potential partners, they see that leverage that we have with the community and the relationships we have. So I think that's something which we are active in.

    但我們擁有的優勢是我們擁有可以引入即插即用產品的基礎設施。所以我認為對我們來說,這是有益的,而且具有成本效益。對於潛在的合作夥伴來說,他們看到了我們與社區的影響力以及我們所擁有的關係。所以我認為這是我們正在積極參與的事情。

  • But obviously, we need to find the right asset at the right price or the right company even.

    但顯然,我們需要以合適的價格找到合適的資產,甚至是合適的公司。

  • Now moving on to your second question around the separation of the Neuroscience business. No, that's not a consideration, just to be very clear about that. I think Teva really benefits from being Teva as a complete Teva. We are fueling a lot of our growth in our innovative business from the support of our generics business and our other businesses. And so there's a lot of synergies that are at play here. And even in R&D, the work that's been done on the complex generics the support they get for the innovative part of our business here is very helpful. So right now, I think where Teva is, it will actually stay as it is and will continue to grow as Teva as one. But thank you for your question.

    現在轉向關於神經科學業務分離的第二個問題。不,這不是一個考慮因素,只是要非常清楚地了解這一點。我認為梯瓦製藥作為一個完整的梯瓦製藥確實受益匪淺。在我們的仿製藥業務和其他業務的支持下,我們正在推動創新業務的大量增長。因此,這裡有很多協同效應在發揮作用。即使在研發方面,在復雜的仿製藥上所做的工作以及他們為我們業務的創新部分獲得的支持也非常有幫助。所以現在,我認為梯瓦公司實際上會保持原樣,並將繼續像梯瓦公司一樣發展。但謝謝你的提問。

  • Operator

    Operator

  • 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。

  • Christopher Thomas Schott - Senior Analyst

    Christopher Thomas Schott - Senior Analyst

  • Just 2 questions for me. First, can you just elaborate a little bit more on gross margin progression as we think about the second half of the year? I'm just trying to get a sense of what's a good number to think about as we kind of think about this, obviously, nice improvement relative to 1Q, but just how much of a normalization should we think about in the second half?

    只需問我 2 個問題。首先,您能否詳細說明一下我們對下半年的毛利率進展情況?我只是想知道什麼是一個好的數字,當我們思考這個問題時,顯然,相對於第一季度有不錯的改進,但我們應該在下半年考慮多少正常化?

  • And then my second question was just a follow-up on UZEDY. Given some of the payer dynamics and this process taking a little bit longer, when can we think about revenue ramping for this product? Is that something we could see in 2023? Or is that more 2024 before you expect the coverage to come into place?

    然後我的第二個問題只是 UZEDY 的後續問題。考慮到付款人的一些動態以及這個過程需要更長的時間,我們什麼時候可以考慮增加該產品的收入?這是 2023 年我們能看到的嗎?或者您預計還要等到 2024 年才能覆蓋範圍?

  • Richard D. Francis - President, CEO & Director

    Richard D. Francis - President, CEO & Director

  • So thanks for those questions. Before I hand over the gross margins to Eli, I just want to sort of lay how people should start to think about our gross margin as our company evolves. So one of the things about gross margin, as Eli highlighted already, it's driven by obviously our cost of goods in our COGS, but also our portfolio mix. And one of the things that I think is important to people start to think about as we grow our innovative business, our portfolio will change and with that changes our profitability and our gross margin from that innovative business.

    謝謝你提出這些問題。在我將毛利率交給 Eli 之前,我只是想告訴大家,隨著公司的發展,人們應該如何開始考慮我們的毛利率。因此,正如 Eli 已經強調的那樣,關於毛利率的因素之一,它顯然是由我們的銷貨成本中的商品成本以及我們的投資組合所驅動的。我認為,隨著我們發展創新業務,人們開始考慮的重要一件事是,我們的投資組合將發生變化,從而改變我們的盈利能力和創新業務的毛利率。

  • And so obviously, growing AUSTEDO, growing UZEDY, growing AJOVY, which is still happening (inaudible) that will continue to move gross margin in the right direction. The second thing which is important to understand in 2023 is H2 will have a higher revenue based on what Eli has just said in H1. So if you take those factors together, it leads us to improving gross margin.

    顯然,AUSTEDO 的增長、UZEDY 的增長、AJOVY 的增長仍在發生(聽不清),這將繼續使毛利率朝著正確的方向發展。 2023 年需要了解的第二件事是,根據 Eli 剛剛在上半年所說的內容,下半年將會有更高的收入。因此,如果綜合考慮這些因素,我們的毛利率就會提高。

  • But I'll hand over to Eli to give you maybe some more specific numbers.

    但我會交給 Eli 來給你一些更具體的數字。

  • Eliyahu Sharon Kalif - Executive VP & CFO

    Eliyahu Sharon Kalif - Executive VP & CFO

  • So thanks, Chris and Richard, I will continue what you mentioned. So first, there are a few dynamics there if you look on the second half of the year. First of all, in terms of the mix of the revenue, we are stepping up with AUSTEDO as we're heading into the second half and the majority of the increase in revenue that came from the distribution business in Anda happened already in the first half which means that mix actually going to change significantly in the second half or the second half in the distribution business in '23 will be the same back in '22.

    謝謝克里斯和理查德,我將繼續你們提到的內容。首先,如果你看看今年下半年,就會發現一些動態。首先,就收入組合而言,隨著我們進入下半年,我們正在加強 AUSTEDO,而來自安達分銷業務的收入增長大部分已經發生在上半年這意味著下半年的組合實際上將發生重大變化,或者23 年下半年的分銷業務將與22 年的情況相同。

  • So that increase actually already happened in the first half and will not keep diluting the gross margin. With that said, there is other activities that we are doing in terms of our cost elements, and we see some also and obviously, a gradual decrease in the inflationary pressures mostly related to cost like logistics, freight and energy as well other elements related to direct material pressures we got in the second half of the year.

    因此,這種增長實際上在上半年就已經發生了,並且不會繼續稀釋毛利率。話雖如此,我們在成本要素方面正在開展其他活動,我們也看到一些明顯的通脹壓力逐漸下降,主要與物流、貨運和能源等成本以及其他相關要素有關。下半年我們受到的直接物質壓力。

  • Last year on procurement from our inventories. Now the numbers to think about it, we're actually yielding to the 53% for the year, which means that gradually, we will see Q3 and Q4 increasing, most likely close to 53.5% range in Q3 and very close to the 54% in the Q4.

    去年從我們的庫存中採購。現在考慮一下數字,我們實際上今年的收益率為 53%,這意味著我們將逐漸看到第三季度和第四季度的增長,很可能接近第三季度的 53.5% 範圍,並且非常接近 54%在第四季度。

  • Richard D. Francis - President, CEO & Director

    Richard D. Francis - President, CEO & Director

  • And Chris, to answer your last question, UZEDY uptake is '23 or '24. Thanks for that question. 2023 is more of the setting up of UZEDY getting access to payers, but also on to formulary committees at hospitals, the D&T committees and making sure people aware of the product. So I don't think of 2023 as the growth driver from a revenue point of view. It's more as we enter 2024. That's when as those things get in place payers and (inaudible) the hospitals then we see that's when the real revenue growth will start. But really pleased with the position. And as Sven highlighted, the (inaudible) sampling that the hospitals are using and the physician interest and uptake now. That obviously helps us get through those formulary committees because the support of the position is really important. So those early signs are very encouraging. But think about modeling in 2024. But thanks for the question, Chris.

    Chris,回答你的最後一個問題,UZEDY 的使用率是“23”或“24”。謝謝你提出這個問題。 2023 年,UZEDY 的建立更多地是為了接觸付款人,同時也接觸醫院的處方委員會、D&T 委員會,並確保人們了解該產品。因此,從收入角度來看,我不認為 2023 年是增長動力。當我們進入 2024 年時,情況會更糟。那時,隨著付款人和(聽不清)醫院這些事情到位,我們就會看到真正的收入增長將開始。但對這個職位真的很滿意。正如斯文強調的那樣,醫院正在使用的(聽不清)採樣以及醫生現在的興趣和採用。這顯然有助於我們通過這些規定委員會,因為該職位的支持非常重要。因此,這些早期跡象非常令人鼓舞。但想想 2024 年的模特界。謝謝你的提問,克里斯。

  • I think that concludes all the questions we have today. So I'd like to thank everybody at for taking the time to call in for people to ask the questions. Hopefully, you found this informative. And we look forward to updating you later in the year on for quarter 3.

    我認為這結束了我們今天提出的所有問題。因此,我要感謝大家花時間打電話詢問問題。希望您能發現本文內容豐富。我們期待在今年晚些時候向您通報第三季度的最新情況。

  • Operator

    Operator

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

    謝謝。感謝您參加今天的電話會議。您現在可以斷開線路。