Teva Pharmaceutical Industries Ltd (TEVA) 2023 Q1 法說會逐字稿

Hello, and welcome to the Q1 2023 Teva Pharmaceutical Industries Limited Earnings Conference Call. My name is Alex. I'll 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，歡迎來到 Teva Pharmaceutical Industries Limited 2023 年第一季度收益電話會議。我的名字叫亞歷克斯。我將協調今天的電話會議。 （操作員說明）我現在將交給您的主持人，投資者關係高級副總裁 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 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。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展示的幻燈片的副本。

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

請查看我們在幻燈片 #2 上的前瞻性聲明。有關這些報表和我們的非 GAAP 財務措施的更多信息可在我們的年度發布和我們的 SEC 表格 10-K 和 10-Q 中找到。

To begin today's call, Richard Francis, Teva's CEO, will provide an overview of Teva's Q1 2023 results and business performance, recent events and priorities going forward. Our CFO, Eli Kalif, will follow up by reviewing the financial results in more detail, including our 2023 financial outlook. Joining Richard and Eli on the call today are Sven Dethlefs, Head of North America business; and Dr. Eric Hughes, our Head of R&D and Chief Medical Officer, 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.

在開始今天的電話會議時，Teva 首席執行官 Richard Francis 將概述 Teva 2023 年第一季度的業績和業務表現、近期事件和未來的優先事項。我們的首席財務官 Eli Kalif 將通過更詳細地審查財務結果來跟進，包括我們的 2023 年財務展望。今天與 Richard 和 Eli 一起參加電話會議的還有北美業務負責人 Sven Dethlefs；以及我們的研發主管兼首席醫療官 Eric Hughes 博士，他將在演講後的問答環節出席。請注意，今天的電話會議將進行大約 1 小時。

And with that, I will now turn the call over to Richard. Richard, if you would, please?

有了這個，我現在將把電話轉給理查德。理查德，你願意嗎？

Thank you, Ran, and good morning and good afternoon, everyone. Thank you also for joining us today.

謝謝你，Ran，大家早上好，下午好。也感謝您今天加入我們。

Now before I start get into the Q1 results, I thought I'd just take a bit of time to give you my thoughts and impressions of the last few months at Teva. Now in short, impressed by many of the things I've seen and discovered while being around the world talking to many of our people. And it's because of this that I think we have real opportunity for the company and maybe the company is underappreciated currently.

現在，在我開始討論第一季度的結果之前，我想我只需要花一點時間來告訴你我對 Teva 過去幾個月的想法和印象。簡而言之，在世界各地與我們的許多人交談時，我所看到和發現的許多事情給我留下了深刻的印象。正因為如此，我認為我們為公司提供了真正的機會，也許公司目前被低估了。

Now let me go into sort of four areas I'd like to focus on here. Now I know most of you think of us as a generics company. And in truth, we are more than that. We have an emerging innovative business, primarily driven by AUSTEDO and AJOVY, but recently about to be supported by UZEDY, a long-acting schizophrenia product, and this is going to fuel continued growth going forward. And already, this is 10% of our total revenue. We also have a biosimilar portfolio, which I'll talk a bit about later, which is an opportunity to benefit from $4 billion of brand value coming off patent in the next few years.

現在讓我談談我想在這裡重點關注的四個領域。現在我知道你們中的大多數人都認為我們是一家仿製藥公司。事實上，我們不止於此。我們有一項新興的創新業務，主要由 AUSTEDO 和 AJOVY 推動，但最近即將得到長效精神分裂症產品 UZEDY 的支持，這將推動未來的持續增長。這已經是我們總收入的 10%。我們還有一個生物仿製藥組合，我稍後會談到，這是一個機會，可以在未來幾年內從專利到期的 40 億美元品牌價值中獲益。

Second, our pipeline. Now I definitely know this is not fully known and understood. But I can tell you, we have some exciting assets here. And as I sort of dug deeper, I've seen some unique capabilities in our R&D organization, particularly when it comes to antibody design and formulation expertise. And as we go through our pipeline, I think you'll see that we have a balanced risk profile on many of our assets.

第二，我們的管道。現在我肯定知道這是不完全了解和理解的。但我可以告訴你，我們這裡有一些令人興奮的資產。隨著我深入挖掘，我在我們的研發組織中看到了一些獨特的能力，特別是在抗體設計和配方專業知識方面。當我們通過我們的管道時，我想你會看到我們對我們的許多資產都有一個平衡的風險狀況。

Now coming to our core business, our core generics business. This is a strong global business. And what I've discovered, this is more than the U.S. In fact, 60% of our business is outside the U.S., in Europe and emerging markets. And this is a strong business and that it generates significant cash, which obviously we're currently using to pay down debt.

現在來到我們的核心業務，我們的核心仿製藥業務。這是一項強大的全球業務。我發現，這比美國還多。事實上，我們 60% 的業務在美國以外、歐洲和新興市場。這是一項強大的業務，它產生了大量現金，顯然我們目前正在使用這些現金來償還債務。

Now then moving on to our people, which is probably what has inspired me the most. We've got a great group of people here at Teva and a great culture. The real can-do attitude. And this is something we're going to leverage as we move forward with Teva, our new strategy for growth.

現在轉向我們的員工，這可能是最激勵我的。我們在 Teva 有一群很棒的人和很棒的文化。真正可以做的態度。這是我們在推進我們的新增長戰略 Teva 時將要利用的東西。

Now that said, we have some headwinds and some short-term challenges, which we'll discuss today, particularly around our cost of goods. But we have plans to deal with these going forward. And because of that, we are reaffirming our guidance for 2023.

話雖如此，我們今天將討論一些不利因素和一些短期挑戰，特別是圍繞我們的商品成本。但我們計劃在未來處理這些問題。正因為如此，我們重申了我們對 2023 年的指導。

Now moving on to the next slide. I would just like to invite everybody to our Investor Day, which we're going to hold in New York next week, where we're going to introduce our new strategy for growth at Teva. This strategy will be built on some of the strong foundations that I described in the previous slide, and I've been working hard with the executive management team here at Teva along with many others in the company to really challenge ourselves to look at how we can with the changing market unlock and create real value for Teva going forward. I'm excited about the outcome. We have made some clear choices in this strategy, some clear prioritization and we have a focused company going forward where the capital allocation will follow this. So as I said, please join us next week where we unveil a new chapter at Teva.

現在轉到下一張幻燈片。我只想邀請大家參加我們下週將在紐約舉行的投資者日，屆時我們將介紹我們在 Teva 的新增長戰略。該戰略將建立在我在上一張幻燈片中描述的一些堅實基礎上，我一直在與 Teva 的執行管理團隊以及公司的許多其他人一起努力工作，真正挑戰自己，看看我們如何可以隨著不斷變化的市場解鎖並為 Teva 創造真正的價值。我對結果感到興奮。我們在這個戰略中做出了一些明確的選擇，一些明確的優先次序，我們有一家專注於未來的公司，資本配置將遵循這一點。所以正如我所說，請在下週加入我們，屆時我們將揭開 Teva 的新篇章。

Now moving on to Q1 performance, let's start with revenues. Our revenues for Q1 versus Q1 2022 were $3.7 billion, up 4%. AUSTEDO was up 10%, AJOVY up 35%, driving that innovative business that I mentioned earlier. And in European generics, in local currency, we're up 12% in local currency and in international markets we're up 9%. So I think a solid performance for Q1 on the revenue.

現在轉到第一季度的表現，讓我們從收入開始。我們第一季度的收入與 2022 年第一季度相比為 37 億美元，增長 4%。 AUSTEDO 上漲了 10%，AJOVY 上漲了 35%，推動了我之前提到的創新業務。在歐洲仿製藥中，以當地貨幣計算，我們以當地貨幣計算上漲了 12%，在國際市場上我們上漲了 9%。所以我認為第一季度的收入表現穩定。

Now taking a look at it from a regional perspective. As you can see, all regions were up in local currency of growth, 2% for North America, 9% in Europe and 8% in international markets. Now I would keep in mind that our revenues are still affected by the strengthening U.S. dollar, and we did have a negative impact of $128 million in quarter 1 versus 2022.

現在從區域的角度來看它。如您所見，所有地區均以當地貨幣計算增長，北美增長 2%，歐洲增長 9%，國際市場增長 8%。現在我要記住，我們的收入仍然受到美元走強的影響，與 2022 年相比，我們在第一季度確實產生了 1.28 億美元的負面影響。

Now moving on to the next slide to talk about AUSTEDO as part of this [innovative] portfolio that I talked about. Revenues were $170 million, up 10% and I was particularly pleased in its TRx was up 28% versus last year. Now I'm very excited about AUSTEDO, particularly because I see this as an untapped opportunity. We have 800,000 -- roughly 800,000 people suffering from this condition and only 120,000 diagnosed and then only 50,000 treated. So we have significant opportunity to grow this product and help patients suffering from this condition.

現在轉到下一張幻燈片，將 AUSTEDO 作為我談到的這個 [創新] 產品組合的一部分進行討論。收入為 1.7 億美元，增長 10%，我特別高興的是它的 TRx 比去年增長了 28%。現在我對 AUSTEDO 感到非常興奮，特別是因為我認為這是一個尚未開發的機會。我們有 800,000 - 大約 800,000 人患有這種疾病，只有 120,000 人被診斷出來，然後只有 50,000 人得到治療。因此，我們有很大的機會來發展這種產品並幫助患有這種疾病的患者。

On the next slide, you'll see this has been further improved, this patient offering with the launch of AUSTEDO XR. This is the once a day formulation. Now I think this is the final piece of the puzzle for AUSTEDO because obviously, as you appreciate, many of these patients are on multiple medications, and thus having a once-a-day offering, I think, really offers some advantage for them and strengthens the product offering for those patients and caregivers.

在下一張幻燈片中，您會看到這一點得到了進一步改進，隨著 AUSTEDO XR 的推出，該患者產品也得到了改善。這是一天一次的配方。現在我認為這是 AUSTEDO 的最後一塊拼圖，因為很明顯，正如您所理解的那樣，這些患者中的許多人都在服用多種藥物，因此我認為每天一次的藥物確實為他們提供了一些優勢，並且加強為這些患者和護理人員提供的產品。

So now moving on to another part of our innovative pipeline, I say portfolio is AJOVY. Now AJOVY's almost reaching $100 million per quarter, currently [sitting] at $95 million, up 36% in North America, up 17% in Europe and up 74% in international markets. So we've grown across all regions, which we're very pleased about. And what I've mentioned before and I'll reiterate what I like about AJOVY is the fact that this was not a product we managed to bring to the market first in its category. In fact, in many areas, we were not and we were lost. But what we've shown with our commercial capability and muscle that despite this, we can achieve growing market share and a significant position in many of the markets often #2. So I still see growth going forward with AJOVY through geographic expansion and expansion of market share.

所以現在轉到我們創新管道的另一部分，我說投資組合是 AJOVY。現在 AJOVY 每季度幾乎達到 1 億美元，目前 [坐] 9500 萬美元，在北美增長 36%，在歐洲增長 17%，在國際市場增長 74%。因此，我們在所有地區都有發展，對此我們感到非常高興。我之前提到過並重申我喜歡 AJOVY 的一點是，這不是我們設法在同類產品中率先推向市場的產品。事實上，在許多領域，我們並沒有迷失方向。但是，儘管如此，我們已經用我們的商業能力和實力表明，我們可以實現不斷增長的市場份額，並在許多通常排名第二的市場中佔據重要地位。因此，我仍然認為 AJOVY 通過地域擴張和市場份額擴大來實現增長。

Now the new product to this innovative family is UZEDY, risperidone, which was approved about 2 weeks ago, and we're excited about this long-acting risperidone. I was recently on a field right in the U.S. with some of our sales representatives and speaking to psychiatrists and clinical nurse practitioners actually about risperidone. But many of them were asking when this long-acting risperidone would be available. And in discussing with them why they are so enthusiastic about it, it came back to our patient-friendly profile. The fact that we have rapid absorption within 6 to 24 hours of administration was important to them. (inaudible) small needle, lower volume. All of these made it an easy-to-use product for them in this patient population.

現在，這個創新系列的新產品是 UZEDY 利培酮，大約 2 週前獲得批准，我們對這種長效利培酮感到興奮。我最近在美國的一個現場與我們的一些銷售代表一起，並與精神科醫生和臨床執業護士談論利培酮。但他們中的許多人都在詢問這種長效利培酮何時上市。在與他們討論為什麼他們對此如此熱情時，它又回到了我們對患者友好的形象。我們在給藥後 6 至 24 小時內迅速吸收這一事實對他們來說很重要。 （聽不清）小針頭，音量較低。所有這些都使其成為該患者群體中易於使用的產品。

Now keep in mind that the long-acting market is a $4 billion opportunity when it comes to schizophrenia. And so with UZEDY in this profile, we think we have a real opportunity to generate some revenue going forward.

請記住，就精神分裂症而言，長效藥物市場是一個價值 40 億美元的機會。因此，有了 UZEDY，我們認為我們有真正的機會在未來產生一些收入。

Now pivoting back to our generics business. As I mentioned before, we have a big business outside the U.S., over 60%, and we're seeing continued strong growth in both of these regions, 12% in local currency in Europe, 9% in international markets. And this is attributed to our core capabilities. We have a good pipeline. We can regularly launch products into our portfolio. We have a good supply chain and we have a good commercial infrastructure. So I see no reason why we cannot continue to leverage this capability going forward.

現在回到我們的仿製藥業務。正如我之前提到的，我們在美國以外有一項大業務，超過 60%，我們看到這兩個地區持續強勁增長，歐洲當地貨幣增長 12%，國際市場增長 9%。這歸功於我們的核心能力。我們有一個很好的管道。我們可以定期將產品發佈到我們的產品組合中。我們擁有良好的供應鍊和良好的商業基礎設施。所以我認為我們沒有理由不能繼續利用這種能力。

Now to move on to our pipeline. And you'll notice for this call, I've separated the innovative pipeline from the biosimilar pipeline. And that's really to start to highlight the pipeline and some of the exciting assets we believe we have. Now I'll just call out a few here, olanzapine long-acting, another long-acting medication for patients -- people suffering from schizophrenia, which will add to our franchise; ICS-SABA in asthma, which is in Phase III; and then TL1-A in Phase II. I'll describe these in a bit more detail in a couple of slides. But obviously, looking forward to presenting more depth in our pipeline next week at our Strategy Day, where Dr. Hughes, our Head of R&D, will be talking about these in far more detail.

現在繼續我們的管道。你會注意到這次電話會議，我將創新管道與生物仿製藥管道分開了。這真的開始突出管道和我們相信我們擁有的一些令人興奮的資產。現在我就在這裡說幾個，奧氮平長效，另一種長效藥物，用於患者——患有精神分裂症的人，這將增加我們的特許經營權；用於哮喘的 ICS-SABA，處於 III 期；然後是第二階段的 TL1-A。我將在幾張幻燈片中更詳細地描述這些。但顯然，期待在下週的戰略日上展示我們的管道中的更多深度，我們的研發主管休斯博士將在會上更詳細地討論這些。

Now moving on to our biosimilar pipeline and franchise. I think what I've said in the past is you need to have a good pipeline and a good portfolio to succeed in biosimilars and to have a good commercial footprint. I think you can see we have both of those. Now to address a question, which I think is going to come up today is about biosimilar Humira and where we are with that. So maybe I can take a few moments to talk about that. So as many of you know, the FDA issued a CRL to our partner, Alvotech, based on certain inspection observations in their facility in Iceland. Now Alvotech is expecting communication from the FDA shortly assessing their responses for their -- these observations. Now once Alvotech received communication from the FDA, we will have a better understanding of the timing of the potential launch of biosimilar Humira.

現在轉向我們的生物仿製藥管道和特許經營權。我認為我過去說過的是，你需要擁有良好的管道和良好的產品組合才能在生物仿製藥領域取得成功並擁有良好的商業足跡。我想你可以看到我們兩者都有。現在要解決一個問題，我認為今天要提出的是關於生物仿製藥 Humira 以及我們的進展情況。所以也許我可以花點時間談談這個。正如你們許多人所知，FDA 根據他們在冰島工廠的某些檢查觀察結果，向我們的合作夥伴 Alvotech 發布了 CRL。現在，Alvotech 期待 FDA 盡快與他們溝通，評估他們對這些觀察結果的反應。現在，一旦 Alvotech 收到 FDA 的通知，我們將更好地了解生物仿製藥 Humira 的潛在上市時間。

Now going back to those promising late-stage assets from our innovative portfolio. Now I don't want to step on Eric Hughes' (inaudible) for next week when we launch the new strategy at the Investor Day, so I'll keep it brief, but maybe just give a slight headline on some of these programs. So olanzapine, we're excited by this because obviously, I mentioned to you already when you said there's a significant opportunity to move the schizophrenia market to a long-acting therapy. Now this olanzapine product leverages our BEPO technology with MedinCell, which is the company we work with on UZEDY. So I'd like to think this has been proven because of obviously the recent approval of UZEDY.

現在回到我們創新投資組合中那些有前途的後期資產。現在我不想在下週我們在投資者日推出新戰略時踩到 Eric Hughes（聽不清），所以我會保持簡短，但也許只是對其中一些計劃給出一個小標題。所以奧氮平，我們對此感到興奮，因為很明顯，當你說有一個重要的機會將精神分裂症市場轉移到長效療法時，我已經向你提到過。現在，這款奧氮平產品利用了我們與 MedinCell 的 BEPO 技術，MedinCell 是我們在 UZEDY 上合作的公司。所以我認為這已經得到證實，因為顯然最近 UZEDY 獲得了批准。

Now moving on to ICS-SABA. This clearly leverages our respiratory expertise and our ability to bring complex products to the market. It brings together two well-characterized and well-used products for a subset of the asthma market, which we believe is worth around $2.5 billion, and we will only have one competitor.

現在轉到 ICS-SABA。這顯然利用了我們的呼吸專業知識和我們將復雜產品推向市場的能力。它為哮喘市場的一個子集匯集了兩種特性良好且使用良好的產品，我們認為該市場的價值約為 25 億美元，我們將只有一個競爭對手。

Then lastly, moving on to the Anti-TL1-A asset, which I'm sure you're all familiar with, as it seems to be a very hot topic right now. We see this as a good opportunity because it's a validated target. And we see because of the number of indications we could potentially go after a significant opportunity around $25 billion. And we believe we have a best-in-class profile, but more to come on those assets on the Investment Day.

最後，轉到 Anti-TL1-A 資產，我相信你們都很熟悉，因為它現在似乎是一個非常熱門的話題。我們認為這是一個很好的機會，因為它是一個經過驗證的目標。而且我們看到，由於有大量跡象表明我們可能會追逐大約 250 億美元的重大機會。我們相信我們擁有一流的形象，但在投資日這些資產上會有更多。

In closing, I want to talk about an important priority of ours, which is our commitment to ESG, and I just want to take a bit of time to give you an insight on the progress we've made. So let me just pick a few of these (inaudible). When it comes to greenhouse gas emissions, we had a goal of to reduce these like to 2020 -- to 25% by 2025. As you can see, we're closing on that already. Another area of focus has been on compliance and business integrity, and we have met our goal of 100% of all our employees trained on compliant policies. Finally, I can highlight the economic impact we've had, $44 billion in savings from Teva's generic medicines across 21 countries, and we've contributed $20 billion to GDP across 24 countries. So I think we've made very good progress with regard to our ESG commitments.

最後，我想談談我們的一個重要優先事項，即我們對 ESG 的承諾，我只想花點時間讓您了解一下我們取得的進展。因此，讓我只選擇其中的一些（聽不清）。在溫室氣體排放方面，我們的目標是到 2020 年將這些排放量減少到 2025 年的 25%。如您所見，我們已經接近尾聲。另一個重點領域是合規性和商業誠信，我們已經實現了所有員工 100% 接受合規政策培訓的目標。最後，我可以強調一下我們所產生的經濟影響，Teva 的仿製藥在 21 個國家節省了 440 億美元，我們為 24 個國家的 GDP 貢獻了 200 億美元。所以我認為我們在 ESG 承諾方面取得了很好的進展。

And with that, I'll hand over to our CFO, Eli?

有了這個，我會交給我們的首席財務官 Eli？

Thank you, Richard, and good morning and good afternoon to everyone. I'll begin my review of our Q1 2023 financial results with Slide 18, starting with our GAAP performance. Revenue in the first quarter of 2023 were $3.7 billion. In dollar term, they were flat compared to the first quarter of 2022. In local currency terms, revenue increased by 4%. To provide you some color on our revenue performance by region. In North America, we had overall solid performance with 2% growth in Q1 2023 compared to the first quarter last year. This growth was mainly driven by higher revenue from certain innovative products, mainly AUSTEDO and AJOVY as well as ANDA, our distribution business. This was partially offset by lower revenues from our generic business and BENDEKA and TREANDA. Our generic business in North America decreased in Q1 2023, mainly due to increasing competition to parts of our portfolio and timing of certain customer (inaudible). The overall pricing environment in North America generics is stable and in line with historical trends.

謝謝你，理查德，大家早上好，下午好。我將從幻燈片 18 開始審查我們 2023 年第一季度的財務業績，首先是我們的 GAAP 業績。 2023 年第一季度的收入為 37 億美元。以美元計算，與 2022 年第一季度相比持平。以當地貨幣計算，收入增長了 4%。為您提供我們按地區劃分的收入表現的一些顏色。在北美，我們整體表現穩健，2023 年第一季度與去年第一季度相比增長了 2%。這一增長主要是由於某些創新產品的收入增加，主要是 AUSTEDO 和 AJOVY 以及我們的分銷業務 ANDA。這部分被我們仿製藥業務以及 BENDEKA 和 TREANDA 的收入減少所抵消。我們在北美的仿製藥業務在 2023 年第一季度有所下降，這主要是由於我們部分產品組合的競爭加劇以及某些客戶的時機（聽不清）。北美仿製藥整體定價環境穩定，符合歷史趨勢。

Revenues in our Europe segment grew strongly by 9% in local currency terms, mainly driven by higher revenue from our generic business, including new product launches. And revenue from our international market segment increased by 8% in local currency terms, mainly due to higher revenues in our generics business coming from price increases largely as a result of raising costs due to inflationary pressures.

以當地貨幣計算，我們歐洲分部的收入強勁增長了 9%，這主要是由於我們仿製藥業務（包括新產品發布）的收入增加所致。我們的國際市場部分的收入以當地貨幣計算增長了 8%，這主要是由於我們的仿製藥業務收入增加，主要是由於通貨膨脹壓力導致成本上升導致的價格上漲。

Operating income was $2 million in the first quarter of 2023 compared to an operating loss of $713 million in the first quarter of 2022. We had a net loss of $205 million compared to a net loss of $955 million in Q1 2022 and a GAAP loss per share of $0.18 compared to GAAP loss per share of $0.86 in the same period a year ago. This improvement in our GAAP operating income, net loss and net loss per share in the first quarter of 2023 were mainly due to the higher impact of legal settlement and loss contingencies that we had in the first quarter of 2022.

2023 年第一季度的營業收入為 200 萬美元，而 2022 年第一季度的營業虧損為 7.13 億美元。我們的淨虧損為 2.05 億美元，而 2022 年第一季度的淨虧損為 9.55 億美元，GAAP 虧損為每股 0.18 美元，而去年同期的 GAAP 每股虧損為 0.86 美元。我們在 2023 年第一季度的 GAAP 營業收入、淨虧損和每股淨虧損的改善主要是由於我們在 2022 年第一季度的法律和解和損失或有事項的影響更大。

Foreign exchange rate improvements during the first quarter of 2023, including hedge effects, negatively impacted our revenue and GAAP operating income by $128 million and $32 million, respectively, compared to the first quarter of 2022. This was a result of the impact of stronger U.S. dollar against other currencies of main markets in which we operate, mainly the euro and other related currencies. As a reminder, approximately 50% of our revenues in Q1 2023 came from sales denominated in non-U.S. dollar currency.

與 2022 年第一季度相比，2023 年第一季度的匯率改善（包括對沖效應）對我們的收入和 GAAP 營業收入分別產生了 1.28 億美元和 3200 萬美元的負面影響。這是美國經濟走強影響的結果。美元兌我們經營所在主要市場的其他貨幣，主要是歐元和其他相關貨幣。提醒一下，我們 2023 年第一季度大約 50% 的收入來自以非美元貨幣計價的銷售額。

Turning to Slide 19. You can see the total non-GAAP adjustments in the first quarter of 2023 were $661 million compared to (inaudible) billion in Q1 2022. A notable non-GAAP adjustment with legal expenses of $233 million, mainly related to estimated provisions recorded in connection with certain litigation cases in the U.S. Other notable adjustments include amortization of purchased intangible assets of $165 million, the majority of which is included in cost of sales and impairment of long-lived assets totaling $188 million.

轉到幻燈片 19。您可以看到 2023 年第一季度的非 GAAP 調整總額為 6.61 億美元，而 2022 年第一季度為（聽不清）十億美元。一項值得注意的非 GAAP 調整，法律費用為 2.33 億美元，主要與估計與美國某些訴訟案件有關的準備金。其他顯著調整包括所購無形資產的攤銷 1.65 億美元，其中大部分計入銷售成本和長期資產減值總額 1.88 億美元。

I also want to provide you with an update on the progress with a nationwide opioid-related litigation settlement. During the previous quarter, we had confirmed a high level of state participation, 49 out of 50 states. Based on the strong state participation, we decided to move ahead to the next phase with the subdivision participation, which I'm happy to report is also going very well. To date, we have confirmed participation from over 99% of the litigating subdivision from those participating states. Overall, with the level of broad support we have seen by the state and subdivisions, we expect to move forward (inaudible) in the process and we anticipate making the first settlement payment in the second half of 2023.

我還想向您提供有關全國阿片類藥物相關訴訟和解的最新進展。在上一季度，我們確認了高水平的州參與，50 個州中的 49 個。基於強大的國家參與，我們決定進入下一階段，細分市場參與，我很高興地報告，這也進展順利。迄今為止，我們已經確認來自這些參與州的超過 99% 的訴訟分部參與了訴訟。總體而言，憑藉我們所看到的州和各部門的廣泛支持水平，我們預計將在此過程中向前推進（聽不清），我們預計將在 2023 年下半年支付第一筆和解金。

Now moving to Slide 20, for a review of our non-GAAP performance. I've already discussed our first quarter revenue, which totaled approximately $3.7 billion and represented a growth of 4% in local currency terms compared to the first quarter of 2022. Now let's move down to P&L and look at the margin. I would like first to drill down and analyze our gross profit performance this quarter. Our non-GAAP gross profit margin was 49.1% in Q1 2023 compared to 54.2% in Q1 2022. The decrease in non-GAAP gross profit margin was driven by two main factors: Our portfolio mix and the macroeconomic factors. Our first quarter came in with a different and unfavorable portfolio mix than we expected. While we continue our solid growth in our key focus area, including AUSTEDO, AJOVY and our generic business in Europe and international markets, this is being offset by margin diluted growth of ANDA business and lower contribution from our legacy brands. As we progress through the year, we anticipate a shift towards a more balanced and normalized portfolio mix in the coming quarter, mainly driven by growth in AUSTEDO and AJOVY. As for the impact of the macroeconomic factors, I already mentioned on our previous earnings call, we faced inflationary pressures in the second half of 2022 and much of that impact from last year was held in our inventory and [sold this] quarter. This resulted in a higher cost of goods sold in Q1 of this year. In addition, we also had some unfavorable impact from hedging activities, which impacted our gross margin, with the majority of the impact in our European and international market segment.

現在轉到幻燈片 20，回顧我們的非 GAAP 業績。我已經討論了我們第一季度的收入，總收入約為 37 億美元，與 2022 年第一季度相比，以當地貨幣計算增長了 4%。現在讓我們轉到損益表，看看利潤率。我想首先深入分析我們本季度的毛利潤表現。 2023 年第一季度，我們的非美國通用會計準則毛利率為 49.1%，而 2022 年第一季度為 54.2%。非美國通用會計準則毛利率下降的主要原因有兩個：我們的投資組合組合和宏觀經濟因素。我們第一季度的投資組合與我們預期的不同且不利。雖然我們繼續在我們的關鍵重點領域實現穩健增長，包括 AUSTEDO 、 AJOVY 和我們在歐洲和國際市場的仿製藥業務，但這被 ANDA 業務的利潤稀釋增長和我們傳統品牌的較低貢獻所抵消。隨著我們今年的進展，我們預計下個季度將轉向更加平衡和規範化的投資組合，這主要受 AUSTEDO 和 AJOVY 增長的推動。至於宏觀經濟因素的影響，我已經在我們之前的財報電話會議上提到過，我們在 2022 年下半年面臨通脹壓力，去年的大部分影響都存在於我們的庫存中，[本季度已售出]。這導致今年第一季度的商品銷售成本更高。此外，我們還受到對沖活動的一些不利影響，這影響了我們的毛利率，其中大部分影響在我們的歐洲和國際市場領域。

Going forward in 2023, we expected improvement on certain elements of the inflationary pressures, including on cost of energy and freight. In addition, we also expected a sequential improvement in our COGS driven by certain measures we are taking in our supply chain. Our non-GAAP operating margin in Q1 2023 was 21.4% versus 27.7% in Q1 2022. This decrease was mainly driven by the lower gross profit margin, as I just mentioned, as well as the higher Other income in the first quarter of 2022, which mainly included onetime settlement proceeds in our international market segment.

展望 2023 年，我們預計通脹壓力的某些因素會有所改善，包括能源和貨運成本。此外，我們還預計，在我們在供應鏈中採取的某些措施的推動下，我們的銷貨成本將有所改善。我們 2023 年第一季度的非美國通用會計準則營業利潤率為 21.4%，而 2022 年第一季度為 27.7%。這一下降主要是由於毛利率較低，正如我剛才提到的，以及 2022 年第一季度其他收入較高，其中主要包括我們國際市場部分的一次性結算收益。

We ended the quarter with a non-GAAP earnings per share of $0.40 compared to $0.55 in Q1 2022, mainly due to the lower gross profit, which I referred to a moment ago.

我們在本季度結束時的非美國通用會計準則每股收益為 0.40 美元，而 2022 年第一季度為 0.55 美元，這主要是由於我剛才提到的毛利潤較低。

Now let's take a look at our spend base on Slide 21. As you can see, our quarterly spend base increased by $229 million or $324 million on a local currency basis. Most of this increase was due to a higher cost of goods sold related to the factors I described earlier as well as the higher other income in the first quarter of 2022, which mainly includes settlement proceeds in our international market segment.

現在讓我們看看我們在幻燈片 21 上的支出基數。如您所見，我們的季度支出基數增加了 2.29 億美元，按當地貨幣計算為 3.24 億美元。這一增長的大部分是由於與我之前描述的因素相關的更高的商品銷售成本以及 2022 年第一季度的更高收入，其中主要包括我們國際市場部分的結算收益。

Our next Slide, 22, shows how we have been transforming our global manufacturing and operating footprint over the last 5 years to consolidate our sites to get more efficient. And here, you can see, over the last 5 years, we have gone from 80 manufacturing sites down to around 52 sites, and we have plans to continue this progress. By the end of 2023, we expect to close or divest three additional sites, with plans already in place to close or divest four additional sites beyond 2023. So this evolution will continue as we drive ongoing optimization of our operations for efficiencies and improving margins.

我們的下一張幻燈片 22 展示了我們在過去 5 年中如何轉變我們的全球製造和運營足跡以整合我們的站點以提高效率。在這裡，你可以看到，在過去的 5 年裡，我們已經從 80 個生產基地減少到大約 52 個基地，我們計劃繼續這一進步。到 2023 年底，我們預計將關閉或剝離另外三個站點，並已製定計劃在 2023 年之後關閉或剝離另外四個站點。因此，隨著我們推動持續優化運營以提高效率和提高利潤率，這種演變將繼續下去。

Turning to free cash flow on Slide 23. Our free cash flow in the first quarter of 2023 was $41 million. Teva's free cash flow tends to face headwinds at the start of the year due to the unusual timing of annual bonus payments paid out in the first quarter. In addition, our free cash flow for Q1 2023 was also impacted by lower profit and changes in working capital items, including an increase in accounts receivable, net of SR&A, partially offset by an increase in accounts payable. 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 pick up during the next 3 quarters as we see a ramp-up in our profitability and as we continue to drive working capital improvement.

轉向幻燈片 23 上的自由現金流。我們在 2023 年第一季度的自由現金流為 4100 萬美元。由於第一季度支付年度獎金的時間不同尋常，Teva 的自由現金流在年初往往會遇到不利因素。此外，我們 2023 年第一季度的自由現金流也受到利潤下降和營運資金項目變化的影響，包括應收賬款增加（扣除 SR&A），部分被應付賬款增加所抵消。今天，我們重申我們在 2 月份提供的 2023 年自由現金流指導。我們 2023 年的自由現金流預計將在 17 億美元至 21 億美元之間。我們預計我們的自由現金流將在未來 3 個季度回升，因為我們看到我們的盈利能力有所提高，並且我們將繼續推動營運資本的改善。

Turning to Slide 24. Our net debt at the end of Q1 2023 was $18.5 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 sernior notes repaid at maturity, partially offset by exchange rate fluctuation of $176 million. Our net debt to EBITDA slightly increase coming at 4.25x for Q1 2023, mainly due to lower EBITDA.

轉到幻燈片 24。我們 2023 年第一季度末的淨債務為 185 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。我們的總債務減少了主要是由於到期償還的 6.46 億美元優先票據，部分被 1.76 億美元的匯率波動所抵消。 2023 年第一季度，我們與 EBITDA 的淨債務略有增加，達到 4.25 倍，這主要是由於 EBITDA 較低。

Looking at Slide 25. Debt reduction continue to be our focus. As you can see, we have made significant progress in the last 6 years to reduce the level of debt on our balance sheet, and we expect this progress to continue and our net debt further decline as we work towards our long-term financial target of being 2x net debt to EBITDA by the end of 2027.

查看幻燈片 25。減少債務仍然是我們的重點。如您所見，過去 6 年我們在降低資產負債表上的債務水平方面取得了重大進展，我們預計隨著我們努力實現長期財務目標，這一進展將繼續下去，我們的淨債務將進一步下降到 2027 年底，淨債務是 EBITDA 的 2 倍。

Turning to Slide 26, which represents our upcoming [update] maturities. During the first quarter of 2023, we successfully refinanced approximately $2.5 billion of our debt through sustainability linked senior notes. This was done to mainly address the '23, '24 and '25 maturities and to align our near-term debt maturities with our free cash flow guidance for this year. These notes are linked to sustainability performance target and [reaffirms] our continuing intention to establish a direct link between our corporate responsibility commitments and our funding strategy. If we combine this recent issuance with our previous (inaudible) bonds financing of $5 billion, Teva is now the second largest corporate (inaudible) issuer worldwide and the largest in the pharmaceutical industry. Given the interest rate environment, this will result in a higher financial expenses for the remainder of the year, which was already accounted for in our 2023 annual guidance that we provided in February.

轉到幻燈片 26，它代表我們即將到來的 [更新] 期限。 2023 年第一季度，我們通過可持續發展相關優先票據成功為約 25 億美元的債務進行再融資。這樣做主要是為了解決 23 年、24 年和 25 年到期的問題，並使我們的近期債務到期與我們今年的自由現金流指導保持一致。這些說明與可持續性績效目標相關聯，並[重申]我們繼續打算在我們的企業責任承諾和我們的融資戰略之間建立直接聯繫。如果我們將最近的發行與我們之前（聽不清）的 50 億美元債券融資相結合，Teva 現在是全球第二大公司（聽不清）發行人，也是製藥行業最大的發行人。鑑於利率環境，這將導致今年剩餘時間的財務費用增加，我們在 2 月份提供的 2023 年年度指導中已經考慮到了這一點。

Now let's turn our attention to our 2023 non-GAAP outlook on Slide 27. As we guided in February, when we provided our full year outlook, we had expected Q1 to be the lowest of the 4 quarters, both in terms of revenues and margins. For full year of 2023, we continue to expect our revenues to be between $14.8 billion to $15.4 billion. We are also reaffirming our 2023 non-GAAP outlook for operating income, EBITDA, earnings per share and free cash flow as provided in February. We continue to expect a gradual pickup in margin in the second quarter with a further progress in the second half of the year. Our company is fully engaged in navigating and addressing the ongoing impact of the macroeconomic headwinds. The inflationary pressures that we saw in the second half of last year continue to have an impact in 2023. As indicated, we are working around certain measures to offset the collective increase in our cost of goods sold. In the coming quarter of '23, we expect a gradual increase in our gross margin with improvement in our portfolio mix. As I mentioned earlier, as well as easing of inflationary pressures, including the cost of energy and freight. In addition, we expect to continue our ongoing efforts to drive improvements in our operating expenses.

現在讓我們將注意力轉向我們在幻燈片 27 上的 2023 年非 GAAP 展望。正如我們在 2 月份提供全年展望時所指導的那樣，我們曾預計第一季度在收入和利潤率方面都是 4 個季度中最低的.對於 2023 年全年，我們繼續預計我們的收入將在 148 億美元至 154 億美元之間。我們還重申 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量展望。我們繼續預計第二季度利潤率將逐步回升，並在下半年取得進一步進展。我們公司正全力應對和應對宏觀經濟逆風的持續影響。我們在去年下半年看到的通脹壓力將在 2023 年繼續產生影響。如前所述，我們正在採取某些措施來抵消我們銷售商品成本的集體增長。在 23 年的下一個季度，我們預計隨著投資組合的改善，我們的毛利率將逐漸增加。正如我之前提到的，以及通脹壓力的緩解，包括能源和貨運成本。此外，我們希望繼續努力推動運營費用的改善。

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

至此，我對 Teva 2023 年第一季度業績的回顧就此結束。現在我將把它交還給理查德進行總結。

Thank you, Eli. Thanks a lot. So in summary, so I'll be reaffirming our 2023 non-GAAP guidance for the year. We believe AUSTEDO and AJOVY are going to continue to drive good growth. With the launch of AUSTEDO once daily, we believe that's going to add to that. And obviously, as I mentioned, the upcoming commercial launch of UZEDY gives opportunity for more growth from our innovative portfolio. With strong performance in Europe and international markets in Q1, and we continue to focus on cost discipline and working capital management. And as of next week, I look forward to introducing our new strategic framework and a few priorities to many of you in person.

謝謝你，伊萊。多謝。總而言之，我將重申我們 2023 年的非 GAAP 指南。我們相信 AUSTEDO 和 AJOVY 將繼續推動良好的增長。隨著 AUSTEDO 每天一次的推出，我們相信這將增加這一點。顯然，正如我所提到的，即將推出的 UZEDY 商業發佈為我們的創新產品組合提供了更多增長的機會。憑藉第一季度在歐洲和國際市場的強勁表現，我們將繼續專注於成本控制和營運資本管理。從下週開始，我期待著親自向你們中的許多人介紹我們的新戰略框架和一些優先事項。

And so with that, I'd like to open up to questions. Thank you.

因此，我想提出問題。謝謝。

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

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

This is (inaudible) for Jason. So first one on the Anti-TL1-A antibody. We saw the preclinical data that you published back in 2018. And from a head-to-head perspective, what do you think drives your confidence that this may compare favorably to maybe for (inaudible) or Pfizer's anti-TL1-A antibody? And then the second question on biosimilar HUMIRA we know that the revenue is risk-adjusted in your 2023 guidance. And last quarter, you mentioned that you have some other hedging elements that might allow you to maintain the guidance if the product was delayed. And so can you share what those elements are?

這是傑森的（聽不清）。所以第一個關於抗 TL1-A 抗體。我們看到了您在 2018 年發布的臨床前數據。從頭對頭的角度來看，您認為是什麼讓您相信這可能比（聽不清）或輝瑞的抗 TL1-A 抗體更好？然後是關於生物仿製藥 HUMIRA 的第二個問題，我們知道收入在您的 2023 年指南中進行了風險調整。上個季度，你提到你有一些其他的對沖因素，如果產品被延遲，這些因素可能會讓你維持指導。那麼你能分享一下這些元素是什麼嗎？

Okay. Thank you for your questions. I'm going to hand the first one on TL1-A. So Eric, can you get it back on [TL1-A] and why we're so excited about it.

好的。謝謝你的問題。我將把第一個放在 TL1-A 上。那麼埃里克，你能把它恢復到 [TL1-A] 上嗎？為什麼我們對此如此興奮。

Yes. Sure. Thank you, Richard. We're very excited about our TL1-A program. The potential to bring a new class of biologics to people suffering from inflammatory bowel disease is very exciting for us. We believe our Anti-TL1-A antibody is highly differentiated and has the potential to be best in class. This is really built on the potency of the antibody and our strategy in the way that we targeted the molecule. We've increased our resources and our efforts to bring this program forward as fast as possible. We understand the interest in this program, and I think we have the best one. So we'll hear more about this next week, as Richard alluded to our new strategy and our pipeline. So we'll talk about that more next week.

是的。當然。謝謝你，理查德。我們對我們的 TL1-A 計劃感到非常興奮。為患有炎症性腸病的人帶來一類新型生物製劑的潛力對我們來說非常令人興奮。我們相信我們的抗 TL1-A 抗體具有高度差異化，並有潛力成為同類產品中的佼佼者。這實際上是建立在抗體的效力和我們針對分子的方式的策略之上的。我們增加了資源和努力，以盡快推進該計劃。我們理解對這個項目的興趣，我認為我們有最好的一個。因此，我們將在下週聽到更多關於這一點的信息，正如理查德提到的我們的新戰略和我們的管道。所以我們將在下週討論更多。

Thanks so much, Eric. And to answer your -- on to your second question on biosimilar HUMIRA, you're right, we did risk-adjusted in our forecast because of the uncertainty that we really existed. What I say is the reason why we're maintaining guidance is, one that was just adjusted, so it's a relatively small amount. The other is we have our launches of UZEDY and our growing innovative pipeline. So because of that, we feel very clear that keeping guidance is the right way to do. So hopefully that answers your questions.

非常感謝，埃里克。並回答你 - 關於你關於生物仿製藥 HUMIRA 的第二個問題，你是對的，我們在預測中進行了風險調整，因為我們確實存在不確定性。我所說的是我們維持指導的原因，這是一個剛剛調整的指導，所以它的數量相對較小。另一個是我們推出了 UZEDY 和我們不斷增長的創新管道。因此，我們非常清楚，保持指導是正確的做法。希望這能回答您的問題。

Yes. And if I could just ask for a follow-up. Should we expect to see any updates to the long-term 2027 targets at the upcoming R&DA?

是的。如果我可以要求跟進。我們是否應該期望在即將到來的 R&DA 中看到 2027 年長期目標的任何更新？

So I suppose there's one I could say I could not answer that question to make you come to the investor and may -- we are -- we haven't changed our guidance for 2027. So we're committed to the operating 30% net debt ratio and also the growth.

所以我想有一個我可以說我無法回答這個問題讓你來找投資者並且可能 - 我們 - 我們沒有改變我們對 2027 年的指導。所以我們致力於 30% 的淨運營負債率和增長。

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。

Maybe if I could spend a quick second on the Phase III olanzapine program. Could you speak to what level of alignment you have on FDA on -- what exactly is it that you need to show in your trial to not get the (inaudible) Black Box Lilly got on their prior attempt that long-acting Zyprexa? And then secondly, on the risperidone program, I know you've shared commentary a few times, but the question I have is, J&J barely did about $300-ish million from a branded sales perspective on that program. So how much could a sort of follow on to that risperidone long-acting molecule truly do? What's the true commercial potential look like?

也許我可以花一點時間在 III 期奧氮平計劃上。你能談談你對 FDA 的一致程度嗎 - 你需要在你的試驗中展示什麼才能不讓（聽不清）禮來（Lilly）之前嘗試使用長效再普樂（Zyprexa）？其次，關於利培酮項目，我知道你已經分享過幾次評論，但我的問題是，從該項目的品牌銷售角度來看，強生公司幾乎沒有做大約 3 億美元。那麼，利培酮長效分子的某種後續作用究竟能起到多大作用呢？真正的商業潛力是什麼樣的？

Thank you, Umer. Thank you for those questions. And I'll hand the first one to Eric again.

謝謝你，烏默爾。謝謝你提出這些問題。我會再次將第一個交給埃里克。

Yes. Thank you, Umer, for asking about our olanzapine program. We're very excited about this program. The prospect of bringing another treatment to patients with schizophrenia is really in our wheelhouse. So we're excited by it. The olanzapine long-acting injectable is building upon our formulation technology that we developed for UZEDY. It's really an ingenious formulation that provides a really advantage to both caregivers and patients. It's given subcutaneously and given the characteristics of the formulation, we really hope to have a favorable safety profile compared to other injections that are available for olanzapine. I think you're referring specifically to the post-injection delirium (inaudible) that has a black box warning on the intramuscular injection of olanzapine. Obviously, we've developed our Phase III program in conjunction with feedback from FDA, and we're confident in the way that we've designed the study with the number of patients and the total number of injections that we'll have what we believe to be a very good safety profile to avoid these side effects. So the study is initiated. I'm very proud to say it's going well, and we're looking forward to the results.

是的。謝謝你，Umer，詢問我們的奧氮平計劃。我們對這個計劃感到非常興奮。為精神分裂症患者提供另一種治療方法的前景確實在我們的駕駛室中。所以我們對此感到興奮。奧氮平長效注射劑基於我們為 UZEDY 開發的配方技術。這確實是一種巧妙的配方，可為護理人員和患者提供真正的優勢。它是皮下給藥並考慮到配方的特點，我們真的希望與其他可用於奧氮平的注射劑相比具有良好的安全性。我認為您具體指的是注射後譫妄（聽不清），它在肌肉注射奧氮平時有一個黑框警告。顯然，我們已經結合 FDA 的反饋制定了我們的 III 期計劃，我們對我們根據患者數量和注射總數設計研究的方式充滿信心相信這是一個非常好的安全配置文件，可以避免這些副作用。於是研究開始了。我很自豪地說它進展順利，我們期待著結果。

Thanks, Eric. So maybe I'll start by answering your question, but I'll also ask Sven, our Head of North America to come in because, obviously, as his team launching risperidone, long-acting UZEDY. So I think we think because of the favorable patient profile we have with the product and the feedback we've got from the physicians and the clinical nurse practitioners already and the unmet medical need, we think we can make some inroads based on the product characteristics I just laid out. So we see the opportunity differently. We think this has an opportunity to catch between -- to grab between 10% to 20% of that $4 billion market. But I'll maybe give the [quarter] spend a bit more flavor to that.

謝謝，埃里克。所以也許我會首先回答你的問題，但我也會請我們的北美負責人 Sven 進來，因為很明顯，當他的團隊推出長效 UZEDY 利培酮時。所以我認為我們認為，由於我們對產品的良好患者形像以及我們已經從醫生和臨床護士那裡得到的反饋以及未滿足的醫療需求，我們認為我們可以根據產品特性取得一些進展我剛鋪好。所以我們以不同的方式看待這個機會。我們認為這是一個抓住機會——抓住這個 40 億美元市場的 10% 到 20%。但我可能會給 [quarter] 花更多的錢。

Yes. Thank you, Richard, and thank you, Umer, for the question. So there are about 1.6 million treated schizophrenia patients in the U.S., 10 of them, as we know, receive long-acting injectable products. The category itself is growing at around about 4% to 5% per year. So it's always good to launch a new franchise into a growing category. We actually believe that we can compete with UZEDY across the LAI spectrum, which means that we do not see users (inaudible) being limited to the risperidone molecule alone. And the main reason that we believe that is that the product profile that makes it ideal for the use in the hospital setting where the majority of the new patients get initiated with LAIs. Among the many key attributes in patient convenience, it's subcutaneous, it has several injection site options, short and narrow needle, small injection volume, we're actually most excited about the pharmacokinetic aspects of the product and especially here the therapeutic levels that can be reached within 24 hours, which is quite important for emergency treatment in hospitals. And we have, as compared to other drugs in the category, no oral supplementation or loading dose. So you can discharge the patient right after first treatments and you are safe that you have here at theratopic levels for 1 or 2 months. And for that reason, we believe we have a highly competitive product in the LAI category. And as I said, we believe we can compete here across all molecules and to set a new standard for LAI treatment.

是的。謝謝 Richard，也謝謝 Umer 提出的問題。因此，在美國大約有 160 萬接受治療的精神分裂症患者，其中 10 人，正如我們所知，接受了長效注射產品。該類別本身每年以大約 4% 到 5% 的速度增長。因此，在不斷增長的類別中推出新的特許經營權總是好的。我們實際上相信我們可以在整個 LAI 範圍內與 UZEDY 競爭，這意味著我們沒有看到用戶（聽不清）僅限於利培酮分子。我們認為，主要原因是產品特性使其非常適合在大多數新患者開始使用 LAI 的醫院環境中使用。在方便患者的眾多關鍵屬性中，它是皮下注射，有多種注射部位選擇，針頭又短又窄，注射量小，實際上我們最感興趣的是該產品的藥代動力學方面，尤其是其治療水平24小時內到達，這對於醫院的急救非常重要。而且，與該類別中的其他藥物相比，我們沒有口服補充劑或負荷劑量。因此，您可以在第一次治療後立即讓患者出院，並且您可以安全地在此處治療 1 或 2 個月。因此，我們相信我們在 LAI 類別中擁有極具競爭力的產品。正如我所說，我們相信我們可以在這裡競爭所有分子，並為 LAI 治療設定新標準。

Our next question comes from Balaji Prasad from Barclays.

我們的下一個問題來自巴克萊銀行的 Balaji Prasad。

Couple for me. Firstly, on biosimilar HUMIRA. I want to understand how much of the setback did (inaudible) in your discussions with the PBMs. What is the role of the negotiations now? And is it fair to assume that 2023 is not the focus of your PBM discussions, one. Two, could you also clarify about the legal settlements that you are taking a provision for? What litigations are these related to? And lastly, if you could just maybe comment further on UZEDY and the market potential for this that you see currently?

情侶給我。首先，關於生物類似藥 HUMIRA。我想了解在您與 PBM 的討論中有多少挫折（聽不清）。現在談判的作用是什麼？並且假設 2023 年不是您 PBM 討論的重點是否公平？第二，你能否也澄清一下你正在為之準備的法律和解？這些訴訟與哪些訴訟有關？最後，您是否可以進一步評論 UZEDY 以及您目前看到的市場潛力？

Okay. Thanks for the question, Balaji. Sven, as you handle PBM, so I'll hand that one to you.

好的。謝謝你的問題，巴拉吉。 Sven，因為你處理 PBM，所以我會把那個交給你。

So of course, we had intense discussions with all major customers, PBMs and all the downstream customers for HUMIRA. (inaudible) of course, changed the situation because our customers have to prepare for the market entry happening end of June and July 1. So now we received the CRL that is, of course, transparent and known to all our customers. And we now have to wait for the outcome of the FDA discussions that Alvotech has concerning the approvability of the biosimilar BLA and also of the interchangeable BLA, and then we will see how we take it forward with the PBMs.

因此，當然，我們與 HUMIRA 的所有主要客戶、PBM 和所有下游客戶進行了激烈的討論。 （聽不清）當然，情況發生了變化，因為我們的客戶必須為 6 月底和 7 月 1 日的市場進入做準備。所以現在我們收到了 CRL，當然，它是透明的，我們所有的客戶都知道。我們現在必須等待 FDA 討論 Alvotech 關於生物仿製藥 BLA 和可互換 BLA 的可批准性的討論結果，然後我們將看到我們如何通過 PBM 推進它。

Thanks, Sven. And the legal settlement, Eli?

謝謝，斯文。法律解決，Eli？

Thanks, Balaji, for the question. Yes. So we had some few adjustments on -- mainly on two cases. One, we're actually progressing on the patient assistance program on COPAXONE with the DOJ and currently, our estimation are around $100 million. This is what we're actually working on and trying to settle it. So this one -- this quarter, we actually at this one -- and the other element that we're actually looking now is kind of a tiny element related to the HIV, the reverse payment within we're actually participating (inaudible) This is a $50 million and the rest is kind of mostly about the timing and other elements relating to a very certain molecules, but that's the high level.

謝謝 Balaji 提出的問題。是的。所以我們主要針對兩種情況進行了一些調整。第一，我們實際上正在與 DOJ 就 COPAXONE 患者援助計劃取得進展，目前，我們的估計約為 1 億美元。這就是我們實際上正在努力解決的問題。所以這個 - 這個季度，我們實際上在這個 - 我們現在正在尋找的另一個元素是與 HIV 相關的一個小元素，我們實際參與的反向支付（聽不清）這個是 5000 萬美元，其餘的主要是關於時間和與特定分子相關的其他元素，但這是高水平的。

Thanks, Eli. And then (inaudible) on UZEDY, maybe to clarify to what Sven said and I said earlier, we think this is a great opportunity based on the product profile we have, the very patient-friendly profile. It's a $4 billion market, based on what we understand about the needs of the patient and the physician feedback. We think we have a very good solution when it comes to our long-acting formulation. We see our subs getting to between 10% and 20% of the market. Let's see how that plays out. I think one thing I would say when it comes to the schizophrenia market and maybe Sven can add a bit of flavor of this, it will take a bit of time. This is a secondary care. This is in hospitals as Sven alluded to. So there's a bit of time to get on for, to get into those hospitals, to get into those departments and outpatient clinics to make sure it's ready and available for when these patients come in. So there is a bit of setting up the system to make sure that happens. But once that's in place, we see this product having a good trajectory. I don't know whether you want to add anything to that, Sven?

謝謝，伊萊。然後（聽不清）在 UZEDY 上，也許是為了澄清 Sven 所說的和我之前所說的，我們認為這是一個很好的機會，基於我們擁有的產品概況，對患者非常友好的概況。根據我們對患者需求和醫生反饋的了解，這是一個價值 40 億美元的市場。我們認為，就我們的長效配方而言，我們有一個非常好的解決方案。我們看到我們的潛艇佔據了 10% 到 20% 的市場份額。讓我們看看結果如何。我想當談到精神分裂症市場時我會說一件事，也許 Sven 可以添加一些味道，這需要一些時間。這是二級護理。正如斯文提到的，這是在醫院裡。因此，有一些時間可以繼續，進入那些醫院，進入那些部門和門診診所，以確保這些患者進來時已經準備好並可以使用。所以需要一些系統設置來確保發生這種情況。但一旦到位，我們就會看到該產品的發展軌跡良好。我不知道你是否想對此添加任何內容，Sven？

I think, Richard, you covered everything. As you said, we are prepared for launch. It will happen in the next days. We have a dedicated sales team both in the field but also for hospital coverage. We're working through the hospital listing, getting reimbursement in all places. And then we believe, of course, the molecule itself is well known. The efficacy is well established. That's clear. And I think we can communicate our product attributes also in a very clear and compelling way. We've done extensive market research to prepare for this launch. So I believe we will have good uptake, although you have to see that in schizophrenia in these indications, you typically have a slower development like in other indications. But I think we are well prepared here.

我想，理查德，你涵蓋了一切。正如您所說，我們已準備好發布。它將在接下來的幾天內發生。我們在現場和醫院都有專門的銷售團隊。我們正在處理醫院名單，在所有地方獲得報銷。然後我們相信，當然，分子本身是眾所周知的。療效已確立。這很清楚。而且我認為我們也可以以非常清晰和引人注目的方式傳達我們的產品屬性。我們進行了廣泛的市場調查，為此次發布做準備。所以我相信我們會有很好的吸收，儘管你必須看到在這些適應症中的精神分裂症，你通常像其他適應症一樣發展緩慢。但我認為我們在這裡做好了充分的準備。

Our next question comes from Ash Verma of UBS.

我們的下一個問題來自瑞銀的 Ash Verma。

So I had to -- one, just on biosimilar Stelara. Are you planning to pursue interchangeability here as this can be an important feature in this self-administer market? And I think Amgen has already filed for interchangeability. And the resolution on the Iceland manufacturing site is still going on. And we understand, I think Stelara is also coming from that site. So can the Stelara launch timeline get impacted here? That's my first one. And then second, so for the free cash flow guidance that you provided, how confident are you on the reaffirm outlook here? I mean typically, gross margin improvements can be gradual and this level of EBITDA deterioration in 1Q, can you reach the free cash flow guide on gross margin improvement alone? Or do you think you need to cut some OpEx as you progress in the year?

所以我不得不——一個，就在生物仿製藥 Stelara 上。您是否打算在這裡追求互換性，因為這可能是這個自我管理市場的一個重要特徵？而且我認為 Amgen 已經申請了可互換性。而關於冰島製造基地的決議仍在進行中。我們知道，我認為 Stelara 也來自那個網站。那麼 Stelara 的發佈時間表會在這裡受到影響嗎？那是我的第一個。其次，對於您提供的自由現金流量指導，您對這裡重申的前景有多大信心？我的意思是，通常情況下，毛利率的改善可以是漸進的，而 EBITDA 在 1Q 的這種惡化水平，你能單獨達到毛利率改善的自由現金流量指南嗎？還是您認為隨著今年的進展，您需要削減一些運營支出？

Thank you, Ash. Thanks for your question. I think on the Stelara one, Sven, if you would like to give that answer and then Eli going on to the free cash flow.

謝謝你，阿什。謝謝你的問題。我想在 Stelara 上，Sven，如果你想給出那個答案，然後 Eli 繼續自由現金流。

Yes. On Stelara, of course, we are also preparing for this launch. Our launch is, of course, dependent on FDA approval, but also on clearance of all the patent aspects around it with J&J. Like for biosimilar license applications, the site inspection will be part of the [review] process. So the Iceland from Alvotech will be inspected for approval of this drug. Concerning your question about interchangeability, we are still looking into this aspect of the drug we will also see now, of course, with the market formation from HUMIRA, how our customers look at interchangeability, but we believe we will have a competitive offering when we come to market with Stelara.

是的。當然，在 Stelara 上，我們也在為這次發布做準備。當然，我們的推出取決於 FDA 的批准，但也取決於與強生公司有關的所有專利方面的許可。與生物仿製藥許可申請一樣，現場檢查將是[審查]過程的一部分。因此，來自 Alvotech 的 Iceland 將接受這種藥物的批准檢查。關於您關於可互換性的問題，我們仍在研究我們現在也會看到的藥物的這一方面，當然，隨著 HUMIRA 的市場形成，我們的客戶如何看待可互換性，但我們相信當我們與 Stelara 一起上市。

Eli, next one?

伊萊，下一個？

Ash, thanks for the question. Yes. So it's a fair question, and I will split it to two. First of all, what we see in the P&L. And I look earlier in the guidance for the year, I (inaudible) now is really close to $15 billion. We are well suited in terms of revenue, and we are in the range. and very well site there, which means that we are growing in our innovative, and we will see more growth also on our generics and as well on outside of the U.S., European and international market. That's going to help us this year in terms of free cash flow. The gross margin will be up largely. But currently, we don't see now any departure from our view on the range on the free cash flow. The second part of it is the working capital element. We actually have a certain enhancement in place in the last year or so, and it's mostly about our optimizations on the inventories and the supply base. So we see from there also a certain level of benefit helping us to support our working capital and free cash flow. So the answer is that we are in the guidance.

阿什，謝謝你的提問。是的。所以這是一個公平的問題，我將把它分成兩個。首先，我們在損益表中看到了什麼。而且我在今年早些時候的指導中看到，我（聽不清）現在真的接近 150 億美元。我們在收入方面非常適合，而且我們在這個範圍內。並且那裡的位置非常好，這意味著我們的創新正在增長，我們將看到我們的仿製藥以及美國、歐洲和國際市場以外的更多增長。這將在今年的自由現金流方面幫助我們。毛利率將大幅上升。但目前，我們現在沒有看到任何偏離我們對自由現金流範圍的看法。它的第二部分是營運資金要素。我們實際上在過去一年左右的時間裡進行了一定的改進，主要是關於我們對庫存和供應基礎的優化。所以我們從那裡也看到了一定程度的好處，幫助我們支持我們的營運資金和自由現金流。所以答案是我們在引導。

Our next question comes from Nathan Rich of Goldman Sachs.

我們的下一個問題來自高盛的 Nathan Rich。

Maybe just following up on the last one. Eli, how much of the gross margin pressure was mix related versus inflation related? And can you maybe just talk about the level of visibility you have into inflationary pressure given there seems to be some lead time there just in terms of confidence of that kind of easing as the year progresses? And then I'd be curious how (inaudible) compared to your expectations for the quarter. I know there's some seasonality to sales, but revenue per script look lower than we expected. So can you just expand on what drove that in the context of your full-year expectations? And how do you think the once-daily dosing improves your positioning with physicians going forward.

也許只是跟進最後一個。 Eli，毛利率壓力中有多少是與混合相關的，而不是與通脹相關的？你能不能談談你對通脹壓力的可見度，因為隨著時間的推移，就對這種寬鬆政策的信心而言，似乎有一些準備時間？然後我很好奇（聽不清）與您對本季度的預期相比如何。我知道銷售有一些季節性，但每個劇本的收入看起來低於我們的預期。那麼，您能否在全年預期的背景下進一步說明是什麼推動了這一點？您如何看待每日一次的給藥方式可以改善您在未來與醫生的定位。

Thank you, Nathan. So handing the first one to Eli.

謝謝你，內森。因此，將第一個交給 Eli。

Yes. So Nathan, thanks for the question. So percentage-wise, if you look year-over-year, there is a 5-point decrease in gross margin. The first element related to inflationary pressures. This is around 2.5 points, like half of the [impact]. This is mostly related, as I mentioned in my prepared remarks, the inventory that we received on the second half of 2022 that embedded in tertiary costs. And that actually went and we consumed and sold the good delivering this quarter. And that main impact really came with across, I would say, cost of flavor and other elements related to direct material costs embedded in the porting pricing and as well energy and freight. Now we see freight and energy rebounding. We had a successful hedging program last year on the energy that helped us to secure a certain rate, and we see the benefit this year. We're going to see a very nice benefit as well in freight in terms of the combinations and how we're managing long and short lead times in order to optimize more on the [ocean versus the sea] as well as consolidation of shipments. That's for that element. The other element is around, I would say, the product mix is kind of between 1 to 1.5 points and the rest is coming really from hedge (inaudible). And so that's how you should frame and think about that difference. And as we look forward in terms of, for your questions about inflation pressures, some sources of labor that happened in the industry in Q4, getting more ease now and a lot of other elements starting to rebound. We see it in the pricing. We see it in how we are sourcing. So we believe that this one will get kind of at least half effect throughout the rest of the year as well if you look on our product mix and the expected revenue more even our innovative portfolio, this one will rebound and give us more accretive margin going forward.

是的。內森，謝謝你的提問。所以從百分比來看，如果你看同比，毛利率下降了 5 個百分點。第一個因素與通脹壓力有關。這大約是 2.5 分，相當於 [影響] 的一半。正如我在準備好的發言中提到的，這主要與我們在 2022 年下半年收到的包含在第三級成本中的庫存有關。這實際上發生了，我們在本季度消費和銷售了交付的商品。我想說，這種主要影響確實伴隨著口味成本和與直接材料成本相關的其他因素，這些因素包含在移植定價以及能源和運費中。現在我們看到貨運和能源反彈。去年我們有一個成功的能源套期保值計劃，幫助我們獲得一定的利率，我們今年看到了好處。我們將在組合方面以及我們如何管理長短交貨時間以優化 [海洋與海洋] 以及貨運合併方面的貨運方面看到非常好的好處。那是那個元素。另一個因素是，我想說，產品組合在 1 到 1.5 點之間，其餘的實際上來自對沖（聽不清）。這就是你應該如何構建和思考這種差異。正如我們期待的那樣，對於你關於通脹壓力的問題，第四季度該行業發生的一些勞動力來源，現在變得更加寬鬆，許多其他因素開始反彈。我們在定價中看到了這一點。我們在採購方式中看到了這一點。因此，我們相信，如果您查看我們的產品組合和預期收入，甚至我們的創新產品組合，這將在今年餘下時間至少產生一半的影響，這將反彈並為我們帶來更多的利潤增長向前。

Thanks, Eli. And then to answer your AUSTEDO questions. It's -- in Q1 AUSTEDO was in line with our expectations, what we had forecast.

謝謝，伊萊。然後回答您的 AUSTEDO 問題。這是 - 在第一季度，AUSTEDO 符合我們的預期，我們的預測。

As I'm sure you're aware, there is a swing factor between Q4 and Q1, largely because of expectative buying an inventory build that happens. But if you look at the sort of fundamentals, the metrics were leading indicators TRx of 28%, NRx of 30%. So as I said in my opening remarks, very excited about AUSTEDO and the potential. Then your question about what does once a day do? I think if we had any one slight weakness with AUSTEDO, if any one, it was once a day. And now we have that. I think the product profile is very strong and is accepted by our physicians as a favorable product profile. So now we're the once a day, I think that strengthens that. And the other thing is we have reallocated resource and capital to AUSTEDO to match the expectations we place on it. We've allocated resources to make sure that can happen. So I think we're well set for AUSTEDO for the rest of the year and building a bit to (inaudible) question and answer there, on margins. I do see with the combination of UZEDY coming, the launch of that, the growth of AUSTEDO, the continued growth of AJOVY and that's going to change our product mix into the high-margin innovative business. So strong expectations and confident about AUSTEDO. Thank you for your question.

正如我確定您知道的那樣，第四季度和第一季度之間存在一個搖擺因素，這主要是因為預期購買會發生庫存構建。但如果你看一下基本面，這些指標是領先指標 TRx 為 28%，NRx 為 30%。因此，正如我在開場白中所說，對 AUSTEDO 及其潛力感到非常興奮。那麼你的問題是每天一次做什麼？我想如果我們對 AUSTEDO 有任何輕微的弱點，如果有的話，那就是每天一次。現在我們有了。我認為產品概況非常強大，並且被我們的醫生接受為有利的產品概況。所以現在我們每天一次，我認為這加強了這一點。另一件事是我們已經將資源和資本重新分配給 AUSTEDO 以符合我們對它的期望。我們已分配資源以確保這能夠發生。所以我認為我們在今年餘下的時間里為 AUSTEDO 做好了準備，並在邊緣建立了一些（聽不清）問答。我確實看到 UZEDY 的結合，它的推出，AUSTEDO 的增長，AJOVY 的持續增長，這將改變我們的產品組合，進入高利潤的創新業務。對AUSTEDO如此強烈的期待和信心。謝謝你的問題。

Our next question comes from Chris Schott of JPMorgan.

我們的下一個問題來自摩根大通的克里斯肖特。

Just two questions for me. I'm just trying to get my hands around the gross margin update. So maybe you could just help us a little bit of what is a reasonable gross margin target for the year when we kind of balance maybe some of the dynamics in 1Q is what sounds like kind of gradual improvement for the rest of the year. So is something like 51% or 52% kind of the right ballpark? Or is it going to bounce back more than that? Just help a little bit just so we don't make more surprises there. And the second question I had is a bigger picture one. I think you're highlighting kind of pipeline capabilities is one of the underappreciated pieces of the Teva's story and see like a number of pipeline assets that you're going to be talking in more depth next week, how do you think about the overall level of investment that Teva is making in R&D? I know you have kind of a hybrid business between generics and brands. When I think about level of investment as a percent of sales, and it's not a perfect metric, but that kind of the low end of the industry on that front. And I'm just trying to kind of balance the resources you're allocating to R&D versus the desire to maybe push this pipeline and maximize pipeline value appropriately going forward.

只問我兩個問題。我只是想了解毛利率更新。因此，也許你可以幫助我們了解今年合理的毛利率目標，當我們有點平衡時，第一季度的一些動態聽起來像是今年剩餘時間的逐步改善。那麼 51% 或 52% 這樣的比例是否合適？還是會反彈得更多？只是提供一點幫助，這樣我們就不會在那裡製造更多驚喜。我的第二個問題是一個更大的問題。我認為你強調的是管道能力是 Teva 故事中被低估的部分之一，並且看到你將在下週更深入地討論的一些管道資產，你如何看待整體水平Teva 在研發方面的投資是多少？我知道你在仿製藥和品牌之間有一種混合業務。當我將投資水平視為銷售額的百分比時，這不是一個完美的指標，但在這方面屬於行業的低端。我只是想在你分配給研發的資源與可能推動這條管道並適當地最大化管道價值的願望之間取得平衡。

Thanks for the questions, Chris. So Eli, you start on the gross margin.

謝謝你的問題，克里斯。所以 Eli，你從毛利率開始。

Thanks, Chris, for the question. So yes, as I mentioned, in the second half of '22, most of the impact was actually coming from what we call sustained cost related to inflationary pressures and now it really depends on the mix that's coming in the quarter on element that you consume for your inventory. What we see for the rest of the year, I will say that we are at the low of the 53% currently and considering on rebounding, I would say, at least half of the impact on the inflationary pressures from the reasons that starting from mid of Q2, start to actually to source as well new inventories that actually embedded a different pricing now as more of the (inaudible) to ease. So I will say it should actually be from low 53$.

謝謝，克里斯，提出這個問題。所以是的，正如我提到的，在 22 年下半年，大部分影響實際上來自我們所說的與通脹壓力相關的持續成本，現在它實際上取決於本季度你消費的元素組合為您的庫存。我們在今年剩餘時間看到的情況是，我們目前處於 53% 的低點，考慮反彈，我想說，至少有一半對通脹壓力的影響來自於從中期開始的原因從第二季度開始，隨著更多（聽不清）的緩解，開始實際採購以及實際嵌入不同定價的新庫存。所以我會說它實際上應該是從低 53 美元起。

Thank you, Eli. Now moving on to the pipeline assets. So if I understand your question correctly, Chris. Do we -- are we allocate enough capital and resources to execute on what we highlight is a good pipeline?

謝謝你，伊萊。現在轉向管道資產。所以，如果我正確理解你的問題，克里斯。我們是否 - 我們是否分配了足夠的資金和資源來執行我們強調的良好管道？

So it's a great question, and we'll give you a bit more flavor to that next week in New York. But yes, in short, we are. We're making sure we prioritize and allocate capital to where the opportunity is to drive growth and profitable growth. And as Eric alluded to, we have some really exciting assets that we think, to a certain degree, are derisked or validated. So to allocate capital to that, it was a very sensible thing to do. So when it comes to that, we are making sure those assets are funded well to go through. And then on our Capital Markets Day, we'll probably give you an idea of how we're thinking about capital allocation. Aross the two different types of business. You talked about from our generics pipeline to our innovative pipeline and how we're managing that. So we'll go into more detail next week. So hope we answer your question, Chris, and thank you for it.

所以這是一個很好的問題，下週我們將在紐約為您提供更多信息。但是，是的，簡而言之，我們是。我們確保我們優先考慮並將資本分配給有機會推動增長和盈利增長的地方。正如埃里克所暗示的那樣，我們擁有一些非常令人興奮的資產，我們認為在某種程度上，這些資產已被降低風險或得到驗證。因此，為此分配資金是一件非常明智的事情。因此，當涉及到這一點時，我們正在確保這些資產有充足的資金來完成。然後在我們的資本市場日，我們可能會讓您了解我們如何考慮資本配置。跨越兩種不同類型的業務。你談到了從我們的仿製藥管道到我們的創新管道以及我們如何管理它。因此，我們將在下週進行更詳細的介紹。所以希望我們能回答你的問題，Chris，謝謝你。

Our final question for today comes from David Amsellem of Piper Sandler.

我們今天的最後一個問題來自 Piper Sandler 的 David Amsellem。

Maybe just expanding upon the last question. In the past, you've talked about 505(b)(2) opportunities and, I guess, I wanted to ask about the balance between 505(b)(2) products, brand products, versus new molecular entities and how you're thinking about it? Or maybe asking differently, how far along the innovation spectrum are you looking to go -- and then secondly, on AUSTEDO, can you just talk about the mix between Tardive and Huntington's Chorea and how you're thinking about the potential impact (inaudible) to the extent that it gets its label expansion for Huntington's?

也許只是擴展最後一個問題。過去，你談到了 505(b)(2) 機會，我想我想問一下 505(b)(2) 產品、品牌產品與新分子實體之間的平衡，以及你如何重新考慮了嗎？或者可能會問不同的問題，你希望在創新領域走多遠——其次，在 AUSTEDO 上，你能談談 Tardive 和亨廷頓舞蹈病之間的混合，以及你如何考慮潛在影響（聽不清）在某種程度上它得到了亨廷頓舞蹈症的標籤擴展？

Thank you, David. Thank you for your question. So if I understood your question correctly, is sort of how do we balance that focus for (inaudible) resource on pure innovation to 505(b)(2). And I think we balance that based on the opportunities that we see that we have already. And then going forward, where we apply resource and capital. So I think the 505(b)(2)s we see as complex generics, the difficult to make. And so that falls in our (inaudible) nicely. And from an innovative point of view, we're leveraging our capability in neuroscience, immunology with a particular focus on this antibody engineering capability we have. So -- we don't think we have to sacrifice one for the other. I think when it comes down to is how do we reallocate capital from the other aspects of 505(b)(2) innovative to mention or we can find the opportunities we have -- right now, we're doing that well. And as you'll see from the strategy next week, we have a clear strategic and operational plan as to how that's going to be done over the longer term. And so I think that's how we're approaching it now. And then with regard to Huntington's disease and tardive dyskensia and the mix of that and [Ingrezza] potentially an upcoming label expansion. I'll hand that back to Sven in the U.S.

謝謝你，大衛。謝謝你的問題。因此，如果我正確理解您的問題，那麼我們如何平衡對（聽不清）純創新資源與 505(b)(2) 的關注。我認為我們會根據我們已經看到的機會來平衡這一點。然後向前邁進，我們在那裡應用資源和資本。所以我認為我們看到的 505(b)(2)s 是複雜的仿製藥，很難製造。所以這很好地屬於我們（聽不清）。從創新的角度來看，我們正在利用我們在神經科學、免疫學方面的能力，特別關注我們擁有的這種抗體工程能力。所以 - 我們認為我們不必為了另一個而犧牲一個。我認為歸根結底是我們如何從 505(b)(2) 創新的其他方面重新分配資本，或者我們可以找到我們擁有的機會——現在，我們做得很好。正如你將從下週的戰略中看到的那樣，我們有一個明確的戰略和運營計劃，說明如何在長期內做到這一點。所以我認為這就是我們現在接近它的方式。然後關於亨廷頓氏病和遲發性運動障礙以及它們和 [Ingrezza] 的混合可能是即將到來的標籤擴展。我會把它還給美國的斯文

Yes. Thank you, Richard. So Huntington's disease is around about 50% of our sales. So 85% is the tardive dyskinesia. If you look at the size of the patient population, tardive dyskinesia is, of course, the larger market, which is still significantly underpenetrated and underserved. So that's all clearly our strategic focus. For Huntington's disease, of course, we are here well established because that was the first indication that we launched. You know that the prescribers that treat Huntington's disease are highly scientific. They value the dose options that we provide, the tradition ability and they also value the long-term efficacy data combined with the safety profile that we have. For that reason, we believe that we are highly competitive in this category despite the anticipated label expansion from Neurocrine. On the other hand, also, we now have with AUSTEDO XR the drug formulation with the once-daily as Richard explained, was missing. We did extensive market research here about the prescriber segments that value these convenience factors. And I think we will have a very competitive product going forward, being it now in tardive dyskinesia or in Huntington's disease. So for that reason, we are quite optimistic for the year 2023 and our growth in both categories going forward.

是的。謝謝你，理查德。因此，亨廷頓舞蹈症約占我們銷售額的 50%。所以85%是遲發性運動障礙。如果您看一下患者人數的規模，遲發性運動障礙當然是更大的市場，該市場的滲透率和服務仍然明顯不足。所以這顯然是我們的戰略重點。當然，對於亨廷頓舞蹈症，我們在這裡已經很成熟了，因為這是我們推出的第一個適應症。你知道治療亨廷頓舞蹈病的處方是高度科學的。他們重視我們提供的劑量選擇、傳統能力，他們還重視長期療效數據以及我們擁有的安全性。出於這個原因，我們相信我們在這一類別中具有很強的競爭力，儘管預期來自 Neurocrine 的標籤擴展。另一方面，我們現在也有了 AUSTEDO XR，就像理查德解釋的那樣，每天一次的藥物配方不見了。我們在這裡對重視這些便利因素的處方者細分市場進行了廣泛的市場調查。而且我認為我們將有一個非常有競爭力的產品向前發展，現在是遲發性運動障礙或亨廷頓氏病。因此，出於這個原因，我們對 2023 年以及我們在這兩個類別中的增長持樂觀態度。

Thank you, Sven. And thank you, again, David, for your questions. I think that concludes all the questions we have time for today. So I want to thank everybody again for dialing in and listening and the ones who asked the questions to doing so. I'd just like to remind you all of the Investor Day we have on May 18 in New York next week, starting at 12 p.m. Eastern Time and look forward to seeing some of you in person now and look forward to hearing and seeing you online if you can't make it in person. Thank you again for your time and attention today and look forward to catching up next week.

謝謝你，斯文。再次感謝大衛提出的問題。我想這就是我們今天有時間提出的所有問題。因此，我想再次感謝大家的撥入和聆聽，以及那些提出問題的人。我只想提醒大家我們下週 5 月 18 日在紐約舉行的投資者日，從中午 12 點開始。東部時間，期待現在能見到你們中的一些人，如果你們不能親自到場，期待在網上聽到你們的聲音和見到你們。再次感謝您今天的時間和關注，期待下週再見。

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。您現在可以斷開線路。