Teva Pharmaceutical Industries Ltd (TEVA) 2022 Q4 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Teva's Fourth Quarter and Full Year 2022 Earnings Call. (Operator Instructions)

美好的一天，謝謝你的支持。歡迎來到 Teva 的第四季度和 2022 年全年收益電話會議。 （操作員說明）

Please be advised that today's conference is being recorded. I would now like to hand the conference over to our first speaker today, Ran Meir, Senior Vice President, Head of Investor Relations. Please go ahead.

請注意，今天的會議正在錄製中。我現在想把會議交給我們今天的第一位發言人，高級副總裁兼投資者關係主管 Ran Meir。請繼續。

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

謝謝你，納迪亞。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。可在我們的網站 tevapharm.com 上找到新聞稿副本以及本次電話會議中展示的幻燈片副本。請查看我們在幻燈片 2 上的前瞻性聲明。有關這些聲明和我們的非 GAAP 財務措施的更多信息可在我們的收益發布以及我們的 SEC 10-K 和 10-Q 表格中找到。

To begin today's call, Richard Francis, Teva's CEO, will provide an overview of Teva's 2022 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 2022 financial outlook. Joining Richard and Eli on the call today is Sven Dethlefs, Head of North America business. who will be available during the question-and-answer session that will follow the presentation. Please note that today's call will run approximately 1 hour.

在開始今天的電話會議時，Teva 的首席執行官 Richard Francis 將概述 Teva 的 2022 年業績和業務表現、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 2022 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。誰將在演講之後的問答環節中出席。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 welcome, everyone. I'm excited to be here today, and I'd like to start by saying it was great meeting many of you in San Francisco at JPMorgan last month. And I look forward to getting to know Teva shareholders, investors and analysts, so that you can have an open dialogue going forward. I'm excited to be here because there's a lot of opportunity at Teva. The team has done a tremendous work to get the company back to a solid foundation. And now there's an opportunity to get back to growth.

謝謝你，Ran，歡迎大家。我很高興今天能來到這裡，首先我想說很高興上個月在舊金山摩根大通見到你們中的許多人。我期待著認識 Teva 的股東、投資者和分析師，這樣你們就可以在未來進行公開對話。我很高興來到這裡，因為 Teva 有很多機會。該團隊為使公司恢復堅實的基礎做出了巨大的努力。現在有機會恢復增長。

Before I start my review of Teva's 2022 results and discuss our guidance for 2023. I would like to update you that I've already initiated a strategic review process with my leadership team. Our teams are already hitting the ground running, and we are working hard on analyzing some of the core strategic questions, how the segments we operate are going to evolve over time, and we understand what options we have. It's going to be a very clear, purposeful strategy with real intent behind it. Every function, every dollar should follow that strategy going forward. Once the work is done around midyear, I'll come back with the team and we'll present that to the market.

在我開始審查 Teva 的 2022 年業績並討論我們對 2023 年的指導之前。我想告訴你最新消息，我已經與我的領導團隊啟動了戰略審查流程。我們的團隊已經開始運作，我們正在努力分析一些核心戰略問題，我們運營的細分市場將如何隨著時間的推移而演變，我們了解我們有哪些選擇。這將是一個非常明確、有目的的戰略，背後有真正的意圖。每個功能，每一美元都應該遵循該戰略。一旦工作在年中左右完成，我將與團隊一起回來，我們將把它推向市場。

Now let's move on to some highlights for 2022. We ended 2022 with revenues of $14.9 billion, and adjusted EBITDA of $4.6 billion. GAAP diluted loss per share was $2.12, and non-GAAP diluted earnings per share was $2.52. You should note that our revenues were still affected by the strengthening of the U.S. dollar during the fourth quarter, and we therefore still seeing significant headwinds from exchange rate movements on our revenues. We had a net impact of $780 million for the full year compared to 2021.

現在讓我們繼續談談 2022 年的一些亮點。我們在 2022 年結束時的收入為 149 億美元，調整後的 EBITDA 為 46 億美元。 GAAP 攤薄每股虧損為 2.12 美元，非 GAAP 攤薄每股收益為 2.52 美元。您應該注意到，我們的收入在第四季度仍然受到美元走強的影響，因此我們仍然看到匯率變動對我們收入的重大不利影響。與 2021 年相比，我們全年的淨影響為 7.8 億美元。

Free cash flow in 2022 was $2.2 billion, and we continue to reduce our debt in accordance with our strategic targets. Net debt is now down to $18.4 billion.

2022 年的自由現金流為 22 億美元，我們將繼續根據我們的戰略目標減少債務。淨債務現在降至 184 億美元。

Moving to the business overview. AUSTEDO, our leading brand is growing very nicely, up 20% year-over-year, and AJOVY also grew across all 3 geographies, U.S., Europe and International markets. I'll further discuss these 2 products in a few minutes.

轉到業務概述。我們的領先品牌 AUSTEDO 增長非常好，同比增長 20%，而 AJOVY 在美國、歐洲和國際市場這三個地區也都有增長。我將在幾分鐘內進一步討論這兩種產品。

We've also seen nice growth in our generics and OTC revenues in Europe, reflecting our strong position there and also some successful product launches. We've also seen good growth in Generics and OTC on international markets through a combination of volume growth as well as price adjustments to address inflation. So good to see 9% growth in Europe and 5% in international in local currency terms.

我們在歐洲的仿製藥和 OTC 收入也有不錯的增長，反映了我們在那裡的強勢地位以及一些成功的產品發布。我們還看到，通過銷量增長和價格調整相結合以應對通貨膨脹，國際市場上仿製藥和非處方藥的良好增長。很高興看到歐洲增長 9%，國際增長 5%（以當地貨幣計算）。

We're also excited about the progress we're making on our pipeline. We recently initiated the Phase 3 trial of subcutaneous long-acting Olanzapine for Schizophrenia, together with UZEDY, our risperidone long-acting product, which I'll talk about in a few minutes. We're developing an exciting franchise for patients suffering from schizophrenia.

我們也對我們在管道上取得的進展感到興奮。我們最近啟動了皮下注射長效奧氮平治療精神分裂症的 3 期試驗，以及我們的利培酮長效產品 UZEDY，我將在幾分鐘後討論。我們正在為患有精神分裂症的患者開發一個令人興奮的特許經營權。

After the nationwide opioid litigation settlement we announced last month that we are moving on with the settlements after receiving poor support from the state of (inaudible). We already stated with 49 of the 50 states and the sign-on process for the state subdivisions has begun. And given the very positive response from the states, we remain optimistic that the settlements will give a similar support for that.

在全國阿片類藥物訴訟和解之後，我們上個月宣布，在收到州（聽不清）的支持不力後，我們將繼續進行和解。我們已經與 50 個州中的 49 個進行了聲明，並且州分區的登錄過程已經開始。鑑於各州的積極回應，我們仍然樂觀地認為定居點將為此提供類似的支持。

Moving on to the next slide to look at our revenue and how it's developing. Overall, you'll see a fairly stable business with the portfolio of products and geographical spread that are well balanced. I'd like to point out that in 2022, Q4 was the strongest quarter in terms of revenue similar to previous years. If you exclude the impact of FX, revenues in Q4 2022 were actually up 1% compared to the fourth quarter of 2021. So in local currency terms, we had a nice single-digit growth in both Europe and international markets.

轉到下一張幻燈片，看看我們的收入及其發展情況。總的來說，您會看到一個相當穩定的業務，其產品組合和地理分佈非常平衡。我想指出，在 2022 年，第四季度是與往年類似的收入最強勁的季度。如果排除外彙的影響，2022 年第四季度的收入實際上比 2021 年第四季度增長了 1%。因此，以當地貨幣計算，我們在歐洲和國際市場都有不錯的個位數增長。

Moving to the next slide and expand on the comment I just made on Europe. It's a market that I'm very positive about. Europe is good, stable business to Teva. In markets like Europe, if you have a good pipeline, good go-to-market model, the business is predictable and it can drive continued growth. And we believe we have all of those elements in our European business. We have a good portfolio, good pipeline and strong leadership in many of the markets. And this also supports a good margin profile, as you can see from the slide. And this is all playing out well. As you can see, revenues grew in Europe in the fourth quarter, 4% in local currency terms, which we're very pleased about.

轉到下一張幻燈片，展開我剛剛對歐洲發表的評論。這是一個我非常看好的市場。歐洲對 Teva 來說是好的、穩定的業務。在歐洲這樣的市場，如果你有良好的渠道、良好的上市模式，業務是可預測的，並且可以推動持續增長。我們相信我們在歐洲業務中擁有所有這些要素。我們在許多市場擁有良好的產品組合、良好的管道和強大的領導地位。正如您從幻燈片中看到的那樣，這也支持良好的保證金概況。這一切都很好。正如你所看到的，第四季度歐洲的收入增長了 4%，以當地貨幣計算，我們對此感到非常高興。

Now moving on to AUSTEDO, our next slide. Quarter 4 was a record quarter for AUSTEDO as we continue to see strong growth in both total and new prescriptions. Revenues grew 20% for the full year and 22% in the fourth quarter. I'm happy to see strong continued development with nice increases in both revenue and the numbers of prescriptions. So all-in-all, the trajectory looks positive. Eli will elaborate on it when we talk about our 2023 outlook.

現在轉到我們的下一張幻燈片 AUSTEDO。第 4 季度是 AUSTEDO 創紀錄的季度，因為我們繼續看到總處方和新處方的強勁增長。全年收入增長 20%，第四季度增長 22%。我很高興看到強勁的持續發展，收入和處方數量都有可觀的增長。總而言之，軌跡看起來是積極的。當我們談論我們的 2023 年展望時，Eli 將對此進行詳細說明。

Now to better understand the potential of AUSTEDO, I'd like to take a look at the next slide. As you can see, there are approximately 785,000 patients suffering from Tardive Dyskinesia in the U.S. But unfortunately, only 15% of these patients are diagnosed and then even more disappointing 5% are getting treatment. So clearly, there is a lot of unmet need. And of course, we're working hard to broaden that base, making sure they can benefit -- the benefit of the product reaches more patients who need this therapy. This will drive increased prescriptions and also presents a significant long-term growth potential for AUSTEDO.

現在為了更好地了解 AUSTEDO 的潛力，我想看看下一張幻燈片。如您所見，美國大約有 785,000 名遲發性運動障礙患者。但不幸的是，這些患者中只有 15% 得到診斷，還有更令人失望的 5% 正在接受治療。很明顯，有很多未滿足的需求。當然，我們正在努力擴大這一基礎，確保他們能夠受益——該產品的好處惠及更多需要這種療法的患者。這將推動處方藥的增加，並為 AUSTEDO 帶來顯著的長期增長潛力。

Now moving onto AJOVY. Full year, our revenues grew more than 20% globally. This was despite the foreign exchange headwinds we faced in Europe and international markets. Now I think AJOVY is a great example of Teva's strong commercial and execution capabilities. As you know, AJOVY was not first-to-market in the U.S. and Europe, but we're still capturing really strong market share and actually second in Europe. So that's been very impressive and another proof point to me that the innovative and commercial go-to-market capabilities of Teva are strong.

現在轉到 AJOVY。全年，我們的全球收入增長超過 20%。儘管我們在歐洲和國際市場面臨外匯逆風，但還是如此。現在我認為 AJOVY 是 Teva 強大的商業和執行能力的一個很好的例子。如您所知，AJOVY 並非首先在美國和歐洲上市，但我們仍然佔據著非常強勁的市場份額，實際上在歐洲排名第二。所以這是非常令人印象深刻的，另一個證據向我表明 Teva 的創新和商業進入市場的能力是強大的。

What we're seeing now in the U.S. is really about slow growth is around the injectable anti-CGRP therapies. And while most of the growth in migraine space is driven by the oral therapies. Outside the U.S., we expect AJOVY to benefit from continued patient growth and launches in additional countries in Europe and international markets.

我們現在在美國看到的是圍繞可注射抗 CGRP 療法的緩慢增長。雖然偏頭痛空間的大部分增長是由口服療法驅動的。在美國以外，我們預計 AJOVY 將受益於患者的持續增長，並在歐洲和國際市場的其他國家推出。

Now moving on to the pipeline, the next slide, please. In my 6 weeks of Teva, I've met with R&D teams. And I have to say that I'm very impressed with the capabilities and the people we have. I was also pleasantly surprised by our innovative pipeline. We plan on sharing more details on it when we discuss our updated strategy throughout this year.

現在轉到管道，請看下一張幻燈片。在 Teva 的 6 週時間裡，我會見了研發團隊。我不得不說，我對我們的能力和人員印象深刻。我也對我們的創新管道感到驚喜。我們計劃在今年全年討論我們的更新戰略時分享更多細節。

Now let me highlight a couple of exciting assets that are under regulatory review. Firstly, on biosimilar to Humira is expected to launch in July 2023, pending FDA approval, which I'll talk about in a bit more detail in a few minutes. I'm also happy that the FDA has accepted for review the BLA for our biosimilar STELARA, and we anticipate that the review will be completed in the second half of this year.

現在讓我重點介紹一些正在接受監管審查的令人興奮的資產。首先，Humira 的生物仿製藥預計將於 2023 年 7 月推出，等待 FDA 的批准，我將在幾分鐘內更詳細地討論這一點。我也很高興 FDA 已經接受審查我們的生物仿製藥 STELARA 的 BLA，我們預計審查將在今年下半年完成。

Moving to our innovative medicines pipeline. As I said before, we are building a strong foundation for the schizophrenia franchise. UZEDY, an important product for patients suffering from schizophrenia which I will elaborate on in the next slide; and Olanzapine long acting, another exciting prospect in the treatment of schizophrenia. We recently moved into a Phase 3 trial.

轉向我們的創新藥物管道。正如我之前所說，我們正在為精神分裂症專營權打下堅實的基礎。 UZEDY，一種針對精神分裂症患者的重要產品，我將在下一張幻燈片中詳細介紹；和長效奧氮平，這是治療精神分裂症的另一個令人興奮的前景。我們最近進入了 3 期試驗。

With olanzapine and (inaudible) steady represent complementary approaches to schizophrenia patient management by addressing unmet needs in the long-acting market. And together with AUSTEDO which treat Tardive Dyskinesia, a side effect for schizophrenia treatment. We're building a strong franchise for schizophrenia therapies.

奧氮平和（聽不清）穩定代表了通過解決長效市場未滿足的需求來管理精神分裂症患者的補充方法。並與 AUSTEDO 一起治療遲發性運動障礙，這是精神分裂症治療的副作用。我們正在建立強大的精神分裂症治療特許經營權。

So moving on to the next slide to talk about UZEDY. As you know, we have resubmitted the file to the FDA for review and expect to have a decision in the first half of this year. So just to frame the market landscape, there are approximately 2 million treated schizophrenia patients in the U.S. and approximately 10% of them receive long-acting injectable products. And this long-acting category is growing steadily. In terms of sales, the overall schizophrenia long-acting market in 2021 was estimated to be $4 billion.

因此，請轉到下一張幻燈片來討論 UZEDY。如您所知，我們已將文件重新提交給 FDA 進行審查，預計將在今年上半年做出決定。因此，為了構建市場格局，美國約有 200 萬接受治療的精神分裂症患者，其中約 10% 接受長效注射產品。而這一長效品類正在穩步增長。在銷售額方面，2021 年整個精神分裂症長效市場估計為 40 億美元。

Now relative to other therapies in the market, UZEDY, our product, will have more patient-friendly injection mechanism, which is subcutaneous, a small needle and is lower volume, and it comes in a ready-to-use prebuilt syringe. Basically, an easy and effective way to get to your therapy. And we are very much looking forward to bringing these benefits to the patients who are suffering from schizophrenia, and we need stable therapy to avoid relapses. Given these profile advantages, we're happy with UZEDY, we're targeting about a 20% market share over time.

現在，相對於市場上的其他療法，我們的產品 UZEDY 將具有對患者更友好的注射機制，即皮下注射、小針頭和體積更小，並且採用即用型預製注射器。基本上，這是一種簡單有效的治療方法。而我們非常期待將這些益處帶給精神分裂症患者，我們需要穩定的治療，避免復發。鑑於這些優勢，我們對 UZEDY 感到滿意，我們的目標是隨著時間的推移獲得約 20% 的市場份額。

Now let's talk about Humira, which I know has been getting a lot of attention recently and is the largest product in the history to face biosimilar competition with annual revenues of over $17 billion. Now based on our most recent updates from our partner, Alvotech, we're pairing for the launch on the first of July this year. The FDA has confirmed that the target date for the decision on Alvotech's application is April 13 of this year.

現在讓我們談談 Humira，據我所知，它最近受到了很多關注，是歷史上面臨生物仿製藥競爭的最大產品，年收入超過 170 億美元。現在，根據我們合作夥伴 Alvotech 的最新更新，我們將在今年 7 月 1 日發布。 FDA 已經確認，對 Alvotech 申請做出決定的目標日期是今年 4 月 13 日。

The FDA has also confirmed that the data provided by Alvotech is sufficient to support a determination of interchangeability. And approval, of course, requires a satisfactory outcome from the upcoming facility inspection or reinspection, should I say, which is scheduled for March. It should be noted that while we are still waiting for the approval in the U.S., Alvotech's biosimilar of Humira is currently being marketed in 17 countries around the world, including Canada and numerous markets across Europe.

FDA 還確認 Alvotech 提供的數據足以支持互換性的確定。當然，批准需要即將進行的設施檢查或重新檢查（我應該說，計劃於 3 月進行）取得令人滿意的結果。值得注意的是，雖然我們仍在等待美國的批准，但 Alvotech 的 Humira 生物仿製藥目前已在全球 17 個國家上市，包括加拿大和歐洲的眾多市場。

Now to be clear, we have risk-adjusted its contribution to our 2023 guidance, similar to the way we risk adjust other significant launches in the U.S. market. That said, we believe biosimilar to Humira, like other biosimilar products will continue to be an important product in our portfolio beyond 2023.

現在要明確的是，我們已經對它對我們 2023 年指導的貢獻進行了風險調整，類似於我們對美國市場其他重要發布進行風險調整的方式。也就是說，我們相信 Humira 的生物仿製藥與其他生物仿製藥產品一樣，將在 2023 年以後繼續成為我們產品組合中的重要產品。

Now moving on to the next slide. ESG is every one's business at Teva. Let me be clear about that. The Board and the executive management team firmly believe that ESG is critical and inseparable to our long-term sustainability and success. Over the last few teams -- the last few years, the team has worked hard to lay strong ESG foundations and formalize our ESG strategy. We have set ambitious and meaningful targets that are tied to our business, enhance the reporting and disclosures and strengthen our governance. Our ESG strategy focused on advancing health and equity through our medicines, minimizing the impact of our operations and products on the planet and dedicating the company to quality ethics and transparency.

現在轉到下一張幻燈片。在 Teva，ESG 是每個人的事。讓我澄清一下。董事會和執行管理團隊堅信，ESG 對我們的長期可持續發展和成功至關重要且不可分割。在過去的幾個團隊中——過去幾年，該團隊一直在努力奠定堅實的 ESG 基礎並正式製定我們的 ESG 戰略。我們制定了與我們的業務相關的雄心勃勃且有意義的目標，加強了報告和披露，並加強了我們的治理。我們的 ESG 戰略側重於通過我們的藥品促進健康和公平，最大限度地減少我們的運營和產品對地球的影響，並致力於公司質量道德和透明度。

So now let's talk about our 2027 long-term targets. First of all, I'd like to say, as I said in the beginning, I do think the management team has done a great job over the last few years to get the company back to a solid foundation. As we define our strategy going forward over the next few months, we will look for the opportunities to prioritize and to reallocate the best position to have long-term growth and success. We'll come back and share that with you with our new strategy around midyear (inaudible) and very much looking forward to it. But with regard to these long-term financial targets, these will remain in place.

那麼現在讓我們談談我們 2027 年的長期目標。首先，我想說的是，正如我一開始所說，我確實認為管理團隊在過去幾年中做得很好，使公司恢復了堅實的基礎。在我們制定未來幾個月的戰略時，我們將尋找機會確定優先次序並重新分配最佳位置，以實現長期增長和成功。我們將在年中左右（聽不清）回來與您分享我們的新戰略，並且非常期待它。但就這些長期財務目標而言，這些目標將保持不變。

And with that, I will hand over to Eli to walk you through the financials.

有了這個，我將交給 Eli 來引導你完成財務。

Thank you, Richard, and good morning and good afternoon to everyone. I'll begin my review of our 2022 financial results with my main focus being on the fourth quarter performance. This will be followed by an introduction to our 2023 GAAP outlook and some of the important assumptions behind it.

謝謝你，理查德，大家早上好，下午好。我將開始審查我們 2022 年的財務業績，主要關注第四季度的業績。隨後將介紹我們的 2023 年 GAAP 展望及其背後的一些重要假設。

Beginning on Slide 16. I would like to start with our Q4 GAAP performance. Revenues in the fourth quarter of 2022 were $3.9 billion, representing a decrease of 5% or increase of 1% in local currency terms compared to the fourth quarter of 2021. This increase was mainly due to higher revenue from ANDA generic products in our Europe segment, AUSTEDO and AJOVY, partially offset by lower revenues from generics products and certain respiratory products in our North America segment as well as COPAXONE.

從幻燈片 16 開始。我想從我們第四季度的 GAAP 表現開始。 2022 年第四季度的收入為 39 億美元，與 2021 年第四季度相比，按當地貨幣計算下降 5% 或增長 1%。這一增長主要是由於歐洲分部 ANDA 仿製藥的收入增加、 AUSTEDO 和 AJOVY ，部分被我們北美分部的仿製藥產品和某些呼吸產品以及 COPAXONE 的收入減少所抵消。

In Q4 2022, we recorded a GAAP operating loss of $855 million compared to operating income of $78 million in Q4 2021, with a net loss of $1.2 billion compared to $159 million in Q4 2021. Any GAAP loss per share of $1.10 compared to $0.14 in the same period a year ago. GAAP operating loss, net loss and loss per share were mainly due to goodwill impairment charges in the fourth quarter of 2022, partially offset by lower legal settlement and loss contingencies. The goodwill impairment charges were mainly related to exchange rate fluctuations in our international markets and update projections in our Teva [staffing] business.

2022 年第四季度，我們的 GAAP 營業虧損為 8.55 億美元，而 2021 年第四季度的營業收入為 7800 萬美元，淨虧損為 12 億美元，而 2021 年第四季度為 1.59 億美元。任何 GAAP 每股虧損為 1.10 美元，而 2021 年第四季度為 0.14 美元一年前的同一時期。 GAAP 營業虧損、淨虧損和每股虧損主要是由於 2022 年第四季度的商譽減值費用，部分被較低的法律結算和損失或有費用所抵消。商譽減值費用主要與我們國際市場的匯率波動和我們 Teva [人員配備] 業務的更新預測有關。

The strengthening of the U.S. dollar versus other currencies during the fourth quarter of 2022, including hedging effects negatively impacted our revenue and GAAP operating income by $270 million and $132 million, respectively, compared to the fourth quarter of 2021.

與 2021 年第四季度相比，2022 年第四季度美元兌其他貨幣走強，包括對沖效應，對我們的收入和 GAAP 營業收入分別產生了 2.7 億美元和 1.32 億美元的負面影響。

Turning to Slide 17. You can see that the total non-GAAP adjustment in the fourth quarter of 2022 were $2 billion, and this is versus $1 billion in Q4 2021. The most notable non-GAAP adjustment was a goodwill impairment charges of $1.3 billion, which I just mentioned.

轉到幻燈片 17。您可以看到 2022 年第四季度的非 GAAP 調整總額為 20 億美元，而 2021 年第四季度為 10 億美元。最顯著的非 GAAP 調整是商譽減值費用 13 億美元，我剛才提到了。

Now moving to Slide 18 for a review of our non-GAAP performance. I've already discussed our fourth quarter revenues, which totaled approximately $3.9 billion. Annual revenues were $14.9 million, a decrease of 6% or 1% in local currency terms compared to 2021. For the full year, we saw the same trend regarding U.S. dollar appreciation, which including hedging effects negatively impacted revenues by $780 million compared to 2021.

現在轉到幻燈片 18，回顧我們的非 GAAP 業績。我已經討論了我們第四季度的收入，總計約為 39 億美元。年收入為 1,490 萬美元，與 2021 年相比，按當地貨幣計算下降 6% 或 1%。全年，我們看到美元升值的相同趨勢，其中包括對沖效應，與 2021 年相比對收入產生了 7.8 億美元的負面影響.

Now let's move down to the P&L and look at the margin. Our non-GAAP gross profit margin was 54.2% compared to 56.1% in Q4 2021. The decrease in non-GAAP gross profit margin was mainly due to the higher revenue with the lower profitability from the ANDA in our North America segment, partially offset by higher revenue from AUSTEDO in our North America segment and a favorable mix of generic products in our Europe segment.

現在讓我們轉到損益表並查看利潤率。我們的非 GAAP 毛利率為 54.2%，而 2021 年第四季度為 56.1%。非 GAAP 毛利率的下降主要是由於我們北美分部的 ANDA 收入增加而盈利能力下降，部分抵消了北美分部來自 AUSTEDO 的更高收入以及歐洲分部的仿製藥的有利組合。

Our non-GAAP operating margin in Q4 '22 was 29.1% versus 30.4% in Q4 '21. This decrease was mainly driven by a lower gross profit margin, I mentioned above, partially offset by lower operating expenses, which I will discuss in the next slide. 2022 for year non-GAAP operating margin was 27.7%, similar levels as in 2021. We ended the quarter with a non-GAAP earnings per share of $0.71 compared to $0.77 in Q4 2021, mainly due to the negative impact from foreign exchange fluctuations and the lower gross profit, partially offset by lower operating expenses as well as lower tax rate.

我們在 22 年第四季度的非 GAAP 營業利潤率為 29.1%，而 21 年第四季度為 30.4%。這種下降主要是由於毛利率較低，我在上面提到過，部分被較低的運營費用所抵消，我將在下一張幻燈片中討論。 2022 年非 GAAP 營業利潤率為 27.7%，與 2021 年水平相似。我們在本季度末的非 GAAP 每股收益為 0.71 美元，而 2021 年第四季度為 0.77 美元，這主要是由於外匯波動的負面影響和較低的毛利潤，部分被較低的運營費用和較低的稅率所抵消。

Now let's take a look at our spend base on Slide 19. As you can see, our quarterly spend base declined by $97 million and increased by $38 million net of FX. For the full year 2022, our total spend base declined by [$691] million or $174 million net of FX, annual decrease in our spend base was due to a lower cost of goods sold related to a lower annual revenue as well as ongoing active management of operating expenses. Looking ahead to 2023, we expect the overall spend base to remain at the level of $11 billion as we continue with our ongoing efforts to transform our global operational networks and ongoing active management of operating expenses.

現在讓我們來看看我們在幻燈片 19 上的支出基數。如您所見，我們的季度支出基數下降了 9700 萬美元，扣除外匯後增加了 3800 萬美元。對於 2022 年全年，我們的總支出基數下降了 [6.91 億美元] 或 1.74 億美元（扣除外匯），我們支出基數的年度下降是由於與較低的年收入相關的銷售成本降低以及持續的積極管理的運營費用。展望 2023 年，我們預計總體支出基數將保持在 110 億美元的水平，因為我們將繼續努力改造我們的全球運營網絡並持續積極管理運營費用。

If you look at Slide 20, we continue our journey to improve margins by reaching 28% operating margin by end of 2023. Despite of some of the macroeconomic headwinds related to the inflationary pressures, and while we continue to face these pressures, our ongoing efforts to reduce and optimize our cost of goods sold and operating expenses are expected to continue to help us partially mitigate this global macroeconomic headwinds. As Richard mentioned earlier, we continue to target 30% operating margin by end of 2027.

如果您查看幻燈片 20，我們將繼續提高利潤率，到 2023 年底營業利潤率將達到 28%。儘管存在一些與通脹壓力相關的宏觀經濟逆風，但在我們繼續面臨這些壓力的同時，我們的持續努力降低和優化我們的銷售成本和運營費用預計將繼續幫助我們部分緩解這一全球宏觀經濟逆風。正如 Richard 之前提到的，我們的目標是到 2027 年底實現 30% 的營業利潤率。

Turning to free cash flow on Slide 21. Our free cash flow in the fourth quarter of 2022 was $1.1 billion, the increase in our free cash flow in the fourth quarter of 2022 compared to the fourth quarter of 2021 resulted mainly from the sale of accounts receivable under a U.S. securitization facility entered into November 2022, partially offset by changes in working capital terms.

轉向幻燈片 21 上的自由現金流。我們 2022 年第四季度的自由現金流為 11 億美元，與 2021 年第四季度相比，我們 2022 年第四季度的自由現金流增加主要是由於出售賬戶2022 年 11 月美國證券化貸款下的應收賬款，部分被營運資本條款的變化所抵消。

For the full year 2022, free cash flow was $2.2 billion, an increase of 2% compared to 2021 and on the high end of our 2022 guidance. Free cash flow in the 2022 was largely affected by the sale of accounts receivable under a new U.S. securitization facility entered in November 2022, partially offset by an increase in inventory levels, lower proceeds from divestitures of business and other assets as well as higher payment of legal settlement in connection with office litigations.

2022 年全年，自由現金流為 22 億美元，比 2021 年增長 2%，處於我們 2022 年指導目標的高端。 2022 年的自由現金流在很大程度上受到 2022 年 11 月進入的新美國證券化工具下出售應收賬款的影響，部分被庫存水平增加、業務和其他資產剝離收益減少以及更高支付額所抵消與辦公室訴訟有關的法律解決。

Turning to Slide 22. Our progress continued in terms of reducing down our debt. The net debt at the end of Q4 2022 was $18.4 billion, compared to $20.9 billion at the end of 2021. The decrease in our gross debt in 2022 was mainly due to the debt repayment, partially offset by exchange rate fluctuation. The decrease in our net debt was mainly due to our free cash flow generation during the year. Our net debt-to-EBITDA ratio continued to decrease coming in 4x for Q4 2022.

轉到幻燈片 22。我們在減少債務方面繼續取得進展。 2022 年第四季度末的淨債務為 184 億美元，而 2021 年末為 209 億美元。我們 2022 年總債務的減少主要是由於償還債務，部分被匯率波動所抵消。我們的淨債務減少主要是由於年內我們產生了自由現金流。我們的淨債務與 EBITDA 比率繼續下降，到 2022 年第四季度為 4 倍。

Looking at Slide 23. Debt reduction continues to be our primary focus. As you can see, we have made significant progress in the last 6 years as we had committed to reduce the level of the debt we had on our balance sheet. During these 6 years, we've paid back approximately $20 billion to our bondholders, including interest payments and we expect our net debt to further decline as we continue to make progress towards 2027 long-term targets.

查看幻燈片 23。減少債務仍然是我們的主要關注點。如您所見，我們在過去 6 年中取得了重大進展，因為我們承諾降低資產負債表上的債務水平。在這 6 年中，我們已經向債券持有人償還了大約 200 億美元，包括利息支付，我們預計隨著我們繼續朝著 2027 年的長期目標取得進展，我們的淨債務將進一步下降。

Turning to Slide 24, which represents our upcoming debt maturities. If you recall, we did a $5 billion SLB refinancing to address the '22, '23 and '24 maturities back in November 2021. We continue to assess market conditions for opportunities to refinance upcoming maturities. Given the interest rate environment, we expect it to result in a higher financial expenses in 2023, which I will discuss in a few moments.

轉到幻燈片 24，它代表我們即將到期的債務。如果您還記得的話，我們在 2021 年 11 月進行了 50 億美元的 SLB 再融資，以解決 22 年、23 年和 24 年到期的問題。我們繼續評估市場狀況，尋找為即將到期的債券再融資的機會。鑑於利率環境，我們預計它會導致 2023 年的財務費用增加，稍後我將對此進行討論。

Looking at the cash conversion on Slide 25. We established a target of 80% by end of 2023. In 2022, we made further progress on this. As we keep focusing on our net working capital enhancements, our efforts to optimize our working capital turns in light of our revenue mix is key for our liquidity. We're really happy to see that it came in at 80%, up from 77% in 2021. As Richard mentioned earlier, we'll continue to manage our business and working capital with a focus on generating cash to earnings at this level.

查看幻燈片 25 上的現金轉換。我們設定了到 2023 年底達到 80% 的目標。2022 年，我們在這方面取得了進一步進展。由於我們一直專注於提高淨營運資本，因此我們根據收入組合優化營運資本的努力是我們流動性的關鍵。我們真的很高興看到它達到了 80%，高於 2021 年的 77%。正如理查德之前提到的，我們將繼續管理我們的業務和營運資本，重點是在這個水平上產生現金收益。

Now let's turn our attention to our 2023 non-GAAP outlook, which we are introducing for the first time today. Here in Slide 26, you will find the 5 main components of our outlook: revenues, operating income, adjusted EBITDA, earnings per share and free cash flow as well as additional components, including expected revenue range for key products. Our company worked hard throughout 2022, navigating and addressing the ongoing impact of the geopolitical and macroeconomic headwinds. We expect this volatile environment in the markets to continue in 2023 based on leading global financial institutions forecast.

現在讓我們將注意力轉向我們今天首次介紹的 2023 年非 GAAP 展望。在幻燈片 26 中，您會發現我們展望的 5 個主要組成部分：收入、營業收入、調整後的 EBITDA、每股收益和自由現金流以及其他組成部分，包括主要產品的預期收入範圍。我們公司在整個 2022 年都在努力工作，應對並應對地緣政治和宏觀經濟逆風的持續影響。根據全球領先金融機構的預測，我們預計這種動蕩的市場環境將在 2023 年繼續。

With this in mind, we begin with 2023 total revenue, which we expect to be between $14.8 billion and $15.4 billion. This is very much in line with our revenue levels in 2022. We expect continued momentum of AUSTEDO with a total annual revenue to grow to approximately $1.2 billion or 24% in 2023. Furthermore, AJOVY is expected to benefit from continued patient growth in the U.S., Europe and international markets. Global sales for AJOVY are expected to be approximately $400 million in 2023.

考慮到這一點，我們從 2023 年的總收入開始，我們預計總收入將在 148 億美元至 154 億美元之間。這與我們 2022 年的收入水平非常一致。我們預計 AUSTEDO 的持續發展勢頭將在 2023 年增長至約 12 億美元或 24%。此外， AJOVY 有望受益於美國患者的持續增長。 、歐洲和國際市場。 2023 年 AJOVY 的全球銷售額預計約為 4 億美元。

We have factored into our guidance the continued erosion of global COPAXONE revenue, which we expect to decline during 2023 to approximately $500 million. The majority of the decline is expected in the U.S. The expected ongoing growth of AUSTEDO and AJOVY is greater than the offset effect by the decline in COPAXONE sales. Our non-GAAP operating income is expected to be between $4 billion and $4.4 billion, and our non-GAAP adjusted EBITDA is expected to be between $4.5 billion and $4.9 billion.

我們已將全球 COPAXONE 收入的持續侵蝕納入我們的指導，我們預計該收入將在 2023 年下降至約 5 億美元。預計大部分下降發生在美國。AUSTEDO 和 AJOVY 的預期持續增長大於 COPAXONE 銷售額下降的抵消效應。我們的非 GAAP 營業收入預計在 40 億美元至 44 億美元之間，我們的非 GAAP 調整後 EBITDA 預計在 45 億美元至 49 億美元之間。

As discussed earlier, we continue to explore opportunities to refinance the upcoming debt maturities to align our debt maturity profile for the coming years with our core operational performance. There could be a meaningful step up in our finance expenses if we were to pursue any refinancing due to the higher interest rate environment. We expect an increase of approximately $100 million reaching $1 billion in 2023.

如前所述，我們繼續探索為即將到期的債務再融資的機會，以使我們未來幾年的債務到期狀況與我們的核心運營績效保持一致。如果我們在更高的利率環境下尋求任何再融資，我們的財務費用可能會大幅增加。我們預計到 2023 年將增加約 1 億美元，達到 10 億美元。

Looking at our tax rate in 2022, our non-GAAP tax rate was 11.7%. As we look ahead to 2023, we expect our tax rate to be in the range of 14% to 17%. You might recall that our non-GAAP tax rate in 2022 was below our initial guidance as it was mainly affected by realization of the loss related from investment in our -- one of our U.S. subsidiaries. This expected increase in our finance expenses, tax rate expected to have significant impact on our EPS 2023 outlook in comparison to 2022. This brings us to the expected earnings per share in the range of $2.25 to $2.55, using a share count of approximately 1.1 billion shares.

看看我們 2022 年的稅率，我們的非 GAAP 稅率為 11.7%。展望 2023 年，我們預計稅率將在 14% 至 17% 之間。您可能還記得，我們 2022 年的非 GAAP 稅率低於我們的初始指導，因為它主要受到實現與我們的一家美國子公司的投資相關的損失的影響。與 2022 年相比，我們的財務費用和稅率預計將對我們的 2023 年每股收益前景產生重大影響。這使我們的預期每股收益在 2.25 美元至 2.55 美元之間，股票數量約為 11 億股分享。

2023 free cash flow is expected to be in the range of $1.7 billion to $2.1 billion This guidance reflects our expected higher plant expenses, which I have outlined before as well as increased legal expenses related to the nationwide opioid settlement. As you know, we do not provide quarterly guidance, but I thought it would be helpful to share with you how we are thinking about the progression the -- both revenue and earnings throughout the year.

2023 年自由現金流量預計在 17 億美元至 21 億美元之間 該指導意見反映了我之前概述的預期更高的工廠費用以及與全國阿片類藥物和解相關的法律費用增加。如您所知，我們不提供季度指導，但我認為與您分享我們如何考慮全年的收入和收益進展會很有幫助。

Based on our expectations to date, we anticipate that similar to the progress in 2022, the first quarter will be the loss of our 4 quarters of revenue and earnings with a gradual pickup in the second quarter. I hope this color will assist you with your modeling. This concludes our review of Teva's results for the fourth quarter and fiscal year 2022.

根據我們迄今為止的預期，我們預計與 2022 年的進展類似，第一季度將是我們 4 個季度的收入和收益損失，第二季度將逐漸回升。我希望這種顏色對你的造型有所幫助。我們對 Teva 第四季度和 2022 財年業績的回顧到此結束。

And now I will hand it back to Richard for a summary.

現在我將把它交還給理查德進行總結。

Thanks, Eli. Before moving to the Q&A, I'd just like to summarize some key points. So I'm happy with the progress that has been made so far, and I want to congratulate the entire team, all my colleagues across the globe on a solid Q4 and full year 2022.

謝謝，伊萊。在進入問答環節之前，我想總結一些要點。因此，我對迄今為止取得的進展感到滿意，我要祝賀整個團隊以及全球所有同事在 2022 年第四季度和全年都表現出色。

AUSTEDO and AJOVY continued to drive growth. And as I mentioned before, there is still a large unmet need that will drive growth in the future for AUSTEDO in the U.S. and AJOVY continues to see good traction, particularly in Europe and international markets.

AUSTEDO 和 AJOVY 繼續推動增長。正如我之前提到的，仍有大量未滿足的需求將推動 AUSTEDO 在美國的未來增長，而 AJOVY 繼續看到良好的牽引力，特別是在歐洲和國際市場。

We have strong performance in Europe and international markets and our European business is steadily growing with leadership positions in most markets. We have an exciting pipeline across innovative medicines, biosimilars and generics. And these interesting and differentiated assets will set us up for future growth. We remain committed to our long-term financial goals around growth, improving margins and driving down debt. And finally, I look forward to sharing with you sometime in mid-year our updated strategy to ensure how we can position Teva for long-term success.

我們在歐洲和國際市場表現強勁，我們的歐洲業務穩步增長，在大多數市場都處於領先地位。我們在創新藥物、生物仿製藥和仿製藥方面擁有令人興奮的管道。這些有趣和差異化的資產將為我們未來的增長做好準備。我們仍然致力於實現圍繞增長、提高利潤率和降低債務的長期財務目標。最後，我期待在年中的某個時候與您分享我們更新後的戰略，以確保我們如何定位 Teva 以取得長期成功。

With that, thank you for listening. I'll now hand you back to the operator for Q&A.

感謝您的收聽。我現在將您交還給接線員進行問答。

(technical difficulty)

（技術難度）

Now we'll start the Q&A session. The first question comes now from the line of Umer Raffat Evercore ISI.

現在我們將開始問答環節。第一個問題現在來自 Umer Rafat Evercore ISI 的線路。

Umer here. A couple of things, if I may. First, on guidance, I think there's a little bit of confusion on how much Humira is in the number. And I guess, said differently, what people are really focused on is, is it still a growth year off of '22, if there was no Humira. That was first. Second, I wanted to touch up on the TL1A program a little bit. Could you tell us if the asthma trial was a complete zero. I know it was terminated.

烏默爾在這裡。如果可以的話，有幾件事。首先，在指導方面，我認為 Humira 的數量有點混亂。我想，換句話說，人們真正關注的是，如果沒有修美樂，它是否仍然是 22 年後的增長年。那是第一個。其次，我想對 TL1A 程序稍作修改。你能告訴我們哮喘試驗是否完全為零嗎？我知道它被終止了。

And also for the IBD Phase 2 you initiated in August last year, how is the recruiting tracking? And could you be in a position to take an interim analysis on 14-week data perhaps later in 2022, which could inform a more accelerated Phase 3 start, just given how competitive this could get.

還有你們去年8月發起的IBD Phase 2，招募進度如何？您是否可以在 2022 年晚些時候對 14 週的數據進行中期分析，這可以為更快地啟動第 3 階段提供信息，只是考慮到這可能會帶來多大的競爭力。

Umer, thanks for the question. So on guidance, as I mentioned, we do have Humira that is risk adjusted. And I think your question was, if we don't have Humira, will we still be able to drive growth. And I think I'll -- Eli contribute, but what I would say is we have a number of opportunities to drive revenue in 2023. Humira is part of that. But obviously, we also talked about AUSTEDO, we've also got UZEDY, and we have other pipeline products that we haven't highlighted in this call. It is an important part, but we've risk adjusted it to take into account the uncertainty. But maybe I'll let Eli give some more color.

烏默爾，謝謝你的提問。因此，正如我提到的那樣，在指導方面，我們確實有經過風險調整的 Humira。我認為你的問題是，如果我們沒有 Humira，我們是否仍然能夠推動增長。我想我會——Eli 做出貢獻，但我要說的是，我們有很多機會在 2023 年增加收入。 Humira 就是其中的一部分。但顯然，我們也談到了 AUSTEDO，我們也有 UZEDY，我們還有其他在本次電話會議中沒有強調的管道產品。這是一個重要的部分，但我們已經對它進行了風險調整以考慮到不確定性。但也許我會讓 Eli 給點顏色。

Yes, Umer, you see the range that we have there, and you can look on the midpoint versus the '22 revenue if you see kind of modest increase, then I will say that -- to echo Richard, what he mentioned, Humira is in the guidance and is risk adjusted. And we have few other elements that might potentially hedge that element if it will not come through.

是的，烏默爾，你看到了我們在那裡的範圍，你可以看看中點與 22 年收入的對比，如果你看到某種程度的增長，那麼我會說 - 回應理查德，他提到的， Humira 是在指南中並進行了風險調整。如果它不會通過，我們幾乎沒有其他元素可以潛在地對沖該元素。

Thanks, Eli. And then going on to your question on the TL1A. It was sort of glad you put up because I think this highlights some of the interesting assets we do have in our pipeline, which will, as I said, fully discussed in midyear when we do a review of our pipeline and let people see some of the things that I'm excited about.

謝謝，伊萊。然後繼續你關於 TL1A 的問題。有點高興你提出來，因為我認為這突出了我們管道中確實擁有的一些有趣的資產，正如我所說，我們將在年中審查我們的管道並讓人們看到一些令我興奮的事情。

But to try and answer your question, we have initiated a clinical Phase 2 basket trial that started in August of 2022 in ulcerative colitis and Crohn's disease. So that is underway. I can't give much more information than that. But as I said, midyear, we'll probably be able to go into a lot more detail on the clinical development plans for that asset and some of the others.

但為了嘗試回答您的問題，我們已經啟動了一項臨床 2 期籃子試驗，該試驗於 2022 年 8 月開始，針對潰瘍性結腸炎和克羅恩病。所以這正在進行中。我不能提供比這更多的信息。但正如我所說，年中，我們可能能夠更詳細地了解該資產和其他一些資產的臨床開發計劃。

And the next question comes from the line of Gary Nachman from BMO.

下一個問題來自 BMO 的 Gary Nachman。

Okay. Great. So Richard, you have a clear strategy of building out your biosimilar capabilities while a competitor decided to sell off its biosimilar.

好的。偉大的。所以理查德，你有一個明確的戰略來建立你的生物仿製藥能力，而競爭對手決定出售其生物仿製藥。

(technical difficulty)

（技術難度）

That's okay. So I'll start over. So you have a clear strategy of building out your biosimilar capabilities while a competitor decided to sell off its biosimilar business. So how much more critical mass do you need to maximize value in that market long term? And then how do you see markets formation, particularly with Humira biosimilars and the benefit of having an interchangeable available. How does that impact your payer discussions? If you could give us some color on that.

沒關係。所以我會重新開始。因此，當競爭對手決定出售其生物仿製藥業務時，你有一個明確的戰略來建立你的生物仿製藥能力。那麼，要在該市場長期實現價值最大化，還需要多少臨界質量？然後你如何看待市場形成，特別是 Humira 生物仿製藥以及具有可互換性的好處。這對您的付款人討論有何影響？如果你能給我們一些顏色。

And then just on the generics business, Richard, will you be able to get back to $1 billion per quarter or so in North America, that was previously a target the company had. Just talk about some of the dynamics there, and you think you'll be able to stabilize that business? Will it continue to decline, maybe talk a little bit at a high level about the pipeline and maybe how that could return that business to growth over time.

然後就在仿製藥業務上，理查德，你能否在北美每季度恢復到 10 億美元左右，這是公司以前的目標。只是談談那裡的一些動態，你認為你能夠穩定那項業務嗎？它會繼續下降嗎，也許會在高層談論管道，也許這會如何使該業務隨著時間的推移恢復增長。

Thanks, Gary. Thanks for your questions. And sticking with us on the technical issues. So on the biosimilar one, I'll take a stab on these questions and also maybe tag team it with some of my colleague.

謝謝，加里。感謝您的提問。並在技術問題上與我們保持一致。因此，在生物仿製藥方面，我將嘗試解決這些問題，並可能與我的一些同事一起將其標記為團隊。

So on the biosimilar, I don't want to comment on other companies' strategies. We're focused on our own. But what I would say is, and I've got a history here, I do believe in the biosimilar opportunity in the market, and I think it's significant. And I think it's significant in the U.S., and I think it's significant in Europe and the rest of the world. I do believe it has an opportunity to drive growth over the short, medium and potential long term. I do think to answer one of your parts of your question, it does require you to have a deep pipeline. And I think one of the things is you've got to be able to continuously launch biosimilar products as they become available.

所以關於生物仿製藥，我不想評論其他公司的策略。我們專注於我們自己。但我要說的是，我在這裡有一段歷史，我確實相信市場上的生物仿製藥機會，而且我認為這很重要。我認為這在美國很重要，在歐洲和世界其他地方也很重要。我確實相信它有機會在短期、中期和潛在的長期內推動增長。我確實認為要回答你問題的一部分，它確實需要你有一個很深的管道。而且我認為其中一件事是你必須能夠在生物仿製藥產品可用時不斷推出它們。

And so I think the team have done a good job here in building out a pipeline. We want to make sure we continue to do that. We want to make sure we continue to have a geographical spread of that pipeline as we go forward. But yes, I see biosimilars as an opportunity to drive growth in the short and medium term.

所以我認為團隊在構建管道方面做得很好。我們希望確保我們繼續這樣做。我們希望確保我們在前進的過程中繼續擁有該管道的地理分佈。但是，是的，我將生物仿製藥視為推動短期和中期增長的機會。

Now when we talk about the market formation of biosimilars Humira. What I would say is let's not forget the size of the price here. This is over $17 billion in the U.S. I was part of the introduction of Humira into the European market. So this is a big asset where I think payers and health care authorities can garner some significant savings. I think that's going to bear out over time.

現在，當我們談論生物仿製藥 Humira 的市場形成時。我要說的是，我們不要忘記這裡價格的大小。這在美國超過 170 億美元。我參與了將 Humira 引入歐洲市場的工作。所以這是一筆巨大的資產，我認為付款人和醫療保健當局可以從中節省大量資金。我認為這會隨著時間的推移得到證實。

I'll let Sven talk a bit about how quickly that can happen. I personally believe the interchangeability in some of the product profile (inaudible) we have biosimilar Humira really differentiates us and allow payers to think about actually switching and transferring patients a bit more easily than they would on other products that don't have those characteristics. But I'll let Sven answer a bit of that.

我會讓 Sven 稍微談談這能多快發生。我個人認為，我們擁有生物仿製藥 Humira 的某些產品簡介（聽不清）中的可互換性確實使我們與眾不同，並允許付款人考慮實際轉換和轉移患者，而不是其他不具有這些特徵的產品。但我會讓 Sven 回答一些問題。

And then on the Gx, I'll take a stab of that as well. In the -- look, I obviously don't have history with this $1 billion comment. And so I can leave that behind from my perspective. What I would say is in the U.S., stability of our generics business should be driven about -- our pipeline what we launch when we launch and the ability to do that. And what we focused on and what we'll continue to focus on is complex generics. Now obviously, they have unpredictability, but when you do get them into the market, they are very profitable and sustainable.

然後在 Gx 上，我也會嘗試一下。在 - 看，我顯然沒有這個 10 億美元評論的歷史。因此，從我的角度來看，我可以將其拋在腦後。我要說的是，在美國，應該推動我們的仿製藥業務的穩定性——我們的管道我們在啟動時啟動什麼以及執行此操作的能力。我們所關注的以及我們將繼續關注的是複雜的泛型。很明顯，它們具有不可預測性，但當你將它們投放市場時，它們是非常有利可圖且可持續的。

So I think for me, it's not so much about getting back to a revenue number to not making sure you have a Gx business that is profitable, predictable and allows you to get growth in the right areas and that comes back to profitability.

所以我認為對我來說，回到收入數字並不是要確保你的 Gx 業務是盈利的、可預測的，並允許你在正確的領域獲得增長並恢復盈利。

But I'll hand over to Sven to give his view on those 2 questions.

但我會請 Sven 發表他對這兩個問題的看法。

Thanks, Gary. I think you were interested in Humira market formation and the benefit of interchangeability. So in what concerns market formation, I think we will go through 3 phases. Phase 1 is right now because Amgen already entered the market with a non-interchangeable Humira biosimilar. Then we have the next inflection point, which will be our market entry it's July 1. And then we see a clear transition towards biosimilars with the formulary changes that come in 2024. So there will be basically 3 phases for the Humira market formation.

謝謝，加里。我認為您對 Humira 市場的形成和互換性的好處感興趣。因此，在市場形成方面，我認為我們將經曆三個階段。第一階段現在是因為 Amgen 已經以不可互換的 Humira 生物仿製藥進入市場。然後我們有下一個拐點，這將是我們的市場准入時間，即 7 月 1 日。然後我們看到隨著 2024 年處方藥的變化，向生物仿製藥的明顯過渡。因此 Humira 市場形成基本上將分為 3 個階段。

I believe we are well positioned. We have discussions with all our customers on the July 1 date. Our customers very well recognized the importance of interchangeability, and I believe it has become even more important since FDA has guided to this year staying on formulary. And if you have EPI, the originator on formulary, of course, you need an interchangeable biosimilar to really drive uptake of biosimilar generics in this space.

我相信我們已經做好了準備。我們在 7 月 1 日與所有客戶進行了討論。我們的客戶非常清楚互換性的重要性，我相信自從 FDA 指導今年繼續使用處方集以來，互換性變得更加重要。如果你有 EPI，處方藥的發起者，當然，你需要一種可互換的生物仿製藥來真正推動生物仿製藥在這個領域的採用。

And we also did recently market research on the question of pull-through with pharmacists and HCPs. And here, we also saw that interchangeability is actually well known in this professional community and especially HCPs look for interchangeability designation when writing biosimilar other than Humira. So I believe, overall, our product profile is quite strong. We have high concentration, citrate-free interchangeable product. We are working towards FDA approval. And for that reason, I believe we can participate in this Phase 2 market formation starting in July.

我們最近還與藥劑師和 HCP 就拉通問題進行了市場研究。在這裡，我們還看到互換性在這個專業社區中實際上是眾所周知的，尤其是 HCP 在編寫 Humira 以外的生物仿製藥時尋找互換性指定。所以我相信，總的來說，我們的產品概況非常強大。我們有高濃度、不含檸檬酸鹽的可互換產品。我們正在努力獲得 FDA 的批准。出於這個原因，我相信我們可以參與從 7 月開始的第二階段市場形成。

And adding to Richard's comments about the complex generics of the U.S. generics business and our run rate. So the run rate was $3.75 billion in 2021 and $3.55 billion in 2022. Our focus is now this year on creating a Humira success and, of course, to bring more complex generics to the market because what we've seen in our portfolio is despite the hurdles that you have for FDA approval with complex generics, they show themselves to be very resilient and drive longer-term value and especially when we look at our gross margin structure, you can see how important complex generics became over the last few years.

並添加了理查德關於美國仿製藥業務的複雜仿製藥和我們的運行率的評論。因此，2021 年的運行率為 37.5 億美元，2022 年為 35.5 億美元。我們今年的重點是創造 Humira 的成功，當然，還要將更複雜的仿製藥推向市場，因為我們在我們的產品組合中看到的是儘管FDA 批准複雜仿製藥的障礙，它們顯示出非常有彈性並推動長期價值，特別是當我們查看我們的毛利率結構時，您可以看到復雜仿製藥在過去幾年中變得多麼重要。

So for this year, we talk about, especially for Forteo as an opportunity, (inaudible) as a second opportunity and then the other complex generics that we also talked about in the previous years, such as Restasis or Simvastatin. And then we have a couple of other complex generics in the pipeline potentially to be launched in 2023 if we get FDA approval.

所以今年，我們談論，特別是 Forteo 作為一個機會，（聽不清）作為第二次機會，然後是我們在前幾年也談論過的其他復雜仿製藥，如 Restasis 或辛伐他汀。然後，如果我們獲得 FDA 批准，我們還有其他一些複雜的仿製藥可能會在 2023 年推出。

This is from the line of Glen Santangelo from Jefferies.

這是來自 Jefferies 的 Glen Santangelo 系列。

Eli, I just wanted to unpack the revenue guidance a little bit more, if I could. I mean essentially, last quarter, you guided fiscal '22 revenues of $14.8 million to $15.4 million. And now you're kind of just rolling that same guidance on '23. And obviously, you're building in some contributions from the growth in AUSTEDO and some risk-adjusted contributions from UZEDY and Humira. So I was wondering if you could just talk about the offsets to that -- to those numbers, to that growth. Will it be the same in '23 as it was in '22? Should we expect sort of a similar type of deceleration in the U.S. generics business and a similar type of runoff in COPAXONE? Or is there something else we should be thinking about, for example, like FX playing a bigger role?

Eli，如果可以的話，我只是想多解釋一下收入指導。我的意思是，基本上，上個季度，你將 22 財年的收入從 1480 萬美元調整到 1540 萬美元。現在你只是在 23 年推出同樣的指南。顯然，您正在建立 AUSTEDO 增長的一些貢獻以及 UZEDY 和 Humira 的一些風險調整貢獻。所以我想知道你是否可以談談對這些數字和增長的抵消。 23 年和 22 年會一樣嗎？我們是否應該期待美國仿製藥業務出現類似類型的減速以及 COPAXONE 出現類似類型的流失？或者還有什麼我們應該考慮的，例如，外匯發揮更大的作用？

Okay. Thank you, Glen, for the question. So a few dynamics in that range. First of all, if you look on the midpoint of 15.1%, you will see versus '22 kind of a modest growth, call it like a 2% and -- but this is based on a risk adjusted in terms of several launches mostly related with North America. Now if you think about the combination of AUSTEDO, AJOVY and COPAXONE, that's actually around $70 million higher than how we came in '22. And we believe that there is still modest opportunities both in AJOVY and AUSTEDO as we're actually running now the trend on the TRx. So that's one element.

好的。格倫，謝謝你提出這個問題。所以在那個範圍內有一些動態。首先，如果你看一下 15.1% 的中點，你會看到相對於 22% 的適度增長，稱其為 2% 並且 - 但這是基於根據主要相關的幾項發布進行風險調整的與北美。現在，如果你考慮 AUSTEDO 、 AJOVY 和 COPAXONE 的組合，這實際上比我們在 22 年的收入高出約 7000 萬美元。我們相信 AJOVY 和 AUSTEDO 仍然存在適度的機會，因為我們現在實際上正在 TRx 上運行趨勢。這是一個要素。

And then a few other elements really related to our stabilized business in Europe in terms of generics and OTC. We see there also kind of a modest growth, and we live in kind of an environment which is very volatile in terms of FX, and we keep kind of enough spread in order to make sure that we're capturing any potential rebounding in terms of mostly on the euro appreciation versus dollars.

然後是其他一些與我們在歐洲的仿製藥和非處方藥方面的穩定業務真正相關的因素。我們也看到了適度的增長，我們生活在一個外匯波動很大的環境中，我們保持足夠的價差，以確保我們捕捉到任何潛在的反彈主要是關於歐元兌美元的升值。

Okay. Maybe if I could just ask one quick follow-up question on the balance sheet. Richard. You sort of seem to suggest that debt reduction remains a primary focus, but how do you think more broadly about the leverage situation, right? Because as Eli sort of talked about in his prepared remarks, right, there's significant maturities coming up in the next sort of few years that are -- at or above the level of free cash flow you're generating now and ultimately, there's going to be some opioid payments that are going to have to be made. So how do you think about getting that debt down to those sort of 27 targets, just sort of given the current level of cash flow that you're generating, how should we think about that over the next couple of years in '23 in particular?

好的。也許我可以在資產負債表上問一個快速的後續問題。理查德。你似乎暗示減少債務仍然是一個主要焦點，但你如何更廣泛地考慮槓桿情況，對嗎？因為正如 Eli 在他準備好的發言中談到的那樣，對，在接下來的幾年裡會有大量到期的債券——達到或高於你現在產生的自由現金流水平，最終，將會有是一些必須支付的阿片類藥物付款。那麼你如何考慮將債務降低到 27 個目標，只是考慮到你目前產生的現金流水平，我們應該如何考慮在接下來的幾年裡，特別是在 23 年？

Thanks for that follow-on question, Glen. And what I'd say before I hand over to Eli is we think (technical difficulty) plan about our debt and repayment of the debt thoroughly and long term. So the way we think about some of the payments we have to pay in '23, '24 and '25, we've been working on for some time. So firstly, just to give you that background. And maybe, Eli, if you could go into more specifics about that.

感謝 Glen 提出的後續問題。在我交給 Eli 之前我要說的是我們認為（技術困難）計劃我們的債務和徹底和長期的債務償還。因此，我們考慮在 23 年、24 年和 25 年必須支付的一些款項的方式，我們已經研究了一段時間。所以首先，只是為了給你那個背景。或許，伊萊，如果你能更詳細地說明這一點。

Okay. Yes, Glen. So looking mostly on liquidity and free cash flow and the debt. So I will start by -- if you look on the guidance we gave for the free cash flow, 1.7 to the 2.1, that mid 1.9%, if you compare it to where we end at '22, call it, around 15% kind of a reduction. This is mostly related to the fact that we are considering coming back to the market to address our '25 maturity debt phase. And that means that we will -- according to the current interest rate environment, we'll need to step up in our fund expenses. So this element that I mentioned already (inaudible) out of this, I would say, a decrease.

好的。是的，格倫。因此，主要關注流動性和自由現金流以及債務。所以我將從 - 如果你看看我們為自由現金流提供的指導，從 1.7 到 2.1，即 1.9%，如果你將它與我們在 22 年結束時的水平進行比較，稱之為 15% 左右的減少。這主要與我們正在考慮重返市場以解決我們的 '25 到期債務階段這一事實有關。這意味著我們將——根據當前的利率環境，我們需要增加基金支出。所以我已經（聽不清）提到的這個元素，我想說，減少了。

Other elements according to the ongoing development with the time lines on the opioid settlement, we see ourselves paying the first payment, and that's actually modeled in our free cash flow generation into Q3 '23. And this is around incremental additional $300 million versus what we paid in '22. So this is kind of the dynamic on that midpoint. Now if you look on the lower end, it's actually 1.7 , part of the refinancing that we're planning in '23 actually planning to -- actually get a bit lower debt take for '23, '24, '25, to the level of 1.7, 1.8 in order to make sure that we have enough cushions to drive the business mostly because of those developments that I mentioned.

根據阿片類藥物結算時間表的持續發展，其他要素我們看到自己支付了第一筆款項，這實際上是在我們的自由現金流生成中模擬到 23 年第三季度。與我們在 22 年支付的費用相比，這大約增加了 3 億美元。所以這是那個中點的動態。現在，如果你看下端，它實際上是 1.7，這是我們計劃在 23 年實際計劃的再融資的一部分——實際上將 23 年、24 年、25 年的債務降低到這個水平1.7、1.8，以確保我們有足夠的緩衝來推動業務，主要是因為我提到的那些發展。

And as I mentioned in my prepared remarks, we have ongoing actions going on our working capital. That cash conversion improvement in the last 3 years mainly coming from those elements. So high level, in terms of liquidity, we see ourselves really strongly positioned in order to -- the ability to start the debt as well to meet our commitments in terms of obligations, mostly with the coming of settlement.

正如我在準備好的發言中提到的，我們正在對營運資金采取持續行動。過去 3 年現金轉換的改善主要來自這些因素。如此高的水平，就流動性而言，我們認為自己確實處於有利地位，以便 - 能夠啟動債務以及履行我們在義務方面的承諾，主要是隨著結算的到來。

This is from the line of Jason Gerberry from Bank of America.

這是來自美國銀行的 Jason Gerberry 系列。

Just wanted to follow up on that free cash flow comment. I think that you used the term incremental for the $300 million of added opioid costs, but I think you had some payments for opioids in 2022. So should we think about that as like the $300 plus? What was kind of the run rate of payments in 2022? Or just the total of about $300 million of opioid-related payments.

只是想跟進自由現金流評論。我認為您使用增量一詞來表示增加的 3 億美元阿片類藥物成本，但我認為您在 2022 年支付了一些阿片類藥物費用。那麼我們是否應該將其視為 300 美元以上？ 2022 年的支付運行率是多少？或者僅僅是約 3 億美元的與阿片類藥物相關的付款總額。

And then on the '23 guidance element, I just wanted to ask the Humira question a little bit differently. So everybody is saying '23 is going to be more of a modest year of biosimilar Humira uptake. But if you were able to get the interchangeability, mindful that you're giving guidance on a risk-adjusted basis, but is there a big upside scenario? Or is it too early to say and you need to kind of get to July contracting before you can kind of comment on that.

然後在 '23 指南元素上，我只是想以不同的方式問 Humira 問題。所以每個人都在說 23 年將是生物仿製藥 Humira 吸收的適度年份。但是，如果您能夠獲得互換性，請注意您是在風險調整的基礎上提供指導，但是否有很大的上行空間？或者現在說還為時過早，您需要等到 7 月簽訂合同才能對此發表評論。

Okay. Thank you, Jason. Thanks for the question. I think I'll hand you, obviously, the opioids and cash to Eli and then Sven can talk about the opportunity with Humira and some of the variables in that. So Eli, first.

好的。謝謝你，傑森。謝謝你的問題。我想我會把阿片類藥物和現金交給 Eli，然後 Sven 可以談論 Humira 的機會以及其中的一些變量。以利，首先。

Yes. So Jason, thanks for the questions. I will clarify. As you recall, we had already before getting to that mature development on the nationwide. We already stated that we settled. And during 2022, we paid already around $130 million in our free cash flow. And that amount will have kind of carry over of around $150 million for next year. Now this is not including the $200 million nationwide that we will need to pay in -- according to the current trajectory of the process in Q3 2023. So you can actually model around $430 million to $450 million that's going to be paid for opioid this year. Is it clear?

是的。傑森，謝謝你的提問。我會澄清的。正如您所記得的，我們已經在全國范圍內進行了成熟的開發。我們已經聲明我們解決了。在 2022 年期間，我們已經支付了大約 1.3 億美元的自由現金流。這一數額將在明年結轉約 1.5 億美元。根據 2023 年第三季度流程的當前軌跡，這還不包括我們需要在全國范圍內支付的 2 億美元。因此，您實際上可以模擬出今年將為阿片類藥物支付的大約 4.3 億至 4.5 億美元.清楚嗎？

Yes, that's clear.

是的，這很清楚。

Yes, okay.

是的，好的。

Okay, Humira. Our plan and the risk adjustment that we took. I think that was the topic. So first of all, we plan as having the interchangeable product in July, so that we get approval for it. Just as a reminder, the weekly process by the FDA for the interchangeable Humira from our partner Alvotech, has been concluded and the outstanding issue for people is now the site inspection that was scheduled for March 6. So we expect if the site inspection will be successful, we get approval for both BLAs that are with the FDA.

好的，休米拉。我們的計劃和我們採取的風險調整。我想這就是主題。所以首先，我們計劃在 7 月推出可互換產品，以便我們獲得批准。提醒一下，FDA 對我們合作夥伴 Alvotech 的可互換 Humira 的每周流程已經結束，現在對人們來說懸而未決的問題是原定於 3 月 6 日進行的現場檢查。所以我們預計現場檢查是否會成功後，我們獲得了 FDA 的兩個 BLA 的批准。

(technical difficulty)

（技術難度）

The guidance that we have. So is there an upside? Of course, there's an upside if we sign all the contracts, and we have a limited number of competition within these contracts. We are quite confident that we can generate pull-through because of the product profile. But we have to wait and see for the next step, and I would say we take it step by step. We're quite confident in approval. We also are quite confident in our ability to supply the market with the required volumes. So that's all on track.

我們的指導。那麼有好處嗎？當然，如果我們簽署所有合同也有好處，而且我們在這些合同中的競爭數量有限。由於產品概況，我們非常有信心可以產生拉動效應。但是下一步我們必須拭目以待，我會說我們會一步一步來。我們對批准很有信心。我們也對我們向市場供應所需數量的能力充滿信心。所以這一切都在軌道上。

Jason, I know that we mean -- we were down for -- it's okay, is that what you need?

傑森，我知道我們的意思是——我們很沮喪——沒關係，這就是你需要的嗎？

Yes.

是的。

This is from Balaji Prasad from Barclays.

這是來自巴克萊銀行的 Balaji Prasad。

Richard, you have articulated the importance of biosimilars for Teva over the next few years. And as I look at the long-term guidance that you provided of mid-single digits, I want to understand the role of specialty segments within this especially as we look at the pipeline and the late-stage assets in specialty as parts?

理查德，你已經闡明了未來幾年生物仿製藥對 Teva 的重要性。當我查看您提供的中個位數的長期指導時，我想了解專業領域在其中的作用，尤其是當我們將專業領域的管道和後期資產視為部分時？

And secondly, coming to this year's guidance, excluding FX and biosimilars Humira, are there any other major variables which influenced the $600 million revenue of $400 million EBITDA spread?

其次，對於今年的指導，不包括 FX 和生物仿製藥 Humira，是否還有其他主要變量影響 4 億美元 EBITDA 利差的 6 億美元收入？

Thanks for the question. I'll take the first part and then maybe tag team with Eli on the second part. So I think your question was around sort of drive growth to our specialty portfolio going forward. So let me sort of touch a bit upon that. I think I highlighted within the call already that the opportunity we still see around AUSTEDO and AJOVY. AUSTEDO particularly when you look about the patient numbers that still are not being treated, I think the opportunity is significant to bring that therapy to a lot more patients. So I see that as a major driver and AJOVY I see as a driver that can probably be worthwhile outside the U.S. as we expand more into Europe and then into international market because of the introduction of the oral therapies into the U.S.

謝謝你的問題。我將參加第一部分，然後可能會與 Eli 一起參加第二部分。所以我認為你的問題是關於推動我們專業產品組合未來的增長。所以讓我稍微談談這個。我想我已經在電話中強調了我們仍然看到圍繞 AUSTEDO 和 AJOVY 的機會。 AUSTEDO 特別是當您查看仍未接受治療的患者數量時，我認為將這種療法帶給更多患者的機會非常重要。所以我認為這是一個主要的驅動因素，而 AJOVY 我認為這是一個可能在美國以外有價值的驅動因素，因為我們將更多的業務擴展到歐洲，然後進入國際市場，因為將口服療法引入美國。

But then I will touch upon the pipeline as well. So you said the risperidone product, we have olanzapine, that product that's gone into Phase 3 clinical trials. So I think -- and then we have our innovative pipeline which we'll talk about midyear, which I see more as the medium term. But excited about it. I think that could bring some significant growth going forward, obviously, if that gets through the clinical development phase. So I think we have a number of assets already. And that's not mentioned some of the complex generics that Sven spoke about earlier, which we're still waiting for FDA approval.

但隨後我也會談到管道。所以你說利培酮產品，我們有奧氮平，該產品已進入 3 期臨床試驗。所以我認為 - 然後我們有我們的創新渠道，我們將在年中討論，我認為這是中期。但是很興奮。我認為，如果能通過臨床開發階段，這顯然會帶來一些顯著的增長。所以我認為我們已經擁有了很多資產。這還沒有提到 Sven 之前談到的一些複雜的仿製藥，我們仍在等待 FDA 的批准。

So I think we're well positioned with our pipeline across specialty, biosimilars and complex generics. Obviously, the challenge always is making sure we get those to markets in a timely fashion, and that's what we're going to be working hard on. Now with regard to the spread on the revenue, I'll let Eli take that and I think your comments are about you understand the FX, you understand the biosimilars, but what else is driving that. So Eli, if you could help you clarity that.

所以我認為我們在專業、生物仿製藥和復雜仿製藥方面處於有利地位。顯然，挑戰始終是確保我們及時將這些產品推向市場，而這正是我們將要努力的方向。現在關於收入的差價，我會讓 Eli 接受，我認為你的評論是關於你了解 FX，你了解生物仿製藥，但還有什麼在推動它。所以 Eli，如果你能幫助你弄清楚這一點。

Yes. So Balaji, thanks for the question. Yes, when you drive the kind of range when you start the year, you look on -- mostly on programs that require (inaudible) adjustments. So in addition to Humira in the U.S. generics, we have a few of them that's risk adjusted. So they might come and be better than what we expect. So this is part of that range and also the -- there is a solid business that we have with Europe generics and OTC even considering, I would say, the average of current run rate in '22 that we see this one (technical difficulty) also with a great potential. So this is -- those 2 elements, I would say, are so part of those range.

是的。巴拉吉，謝謝你的提問。是的，當你在年初開始這種範圍時，你會看到 - 主要是需要（聽不清）調整的程序。因此，除了美國仿製藥中的 Humira 之外，我們還有一些風險調整後的藥物。所以他們可能會比我們預期的更好。所以這是該範圍的一部分，而且 - 我們與歐洲仿製藥和 OTC 有穩固的業務，我想說，我們看到這個（技術難度）的 22 年當前運行率的平均值也具有很大的潛力。所以這是——我想說的是，這兩個元素是這些範圍的一部分。

This is from the line of Elliot Wilbur from Raymond James.

這是來自 Raymond James 的 Elliot Wilbur 系列。

Maybe I could ask Sven to just follow up on the last question with respect to sort of the range of possibilities within the North American Generics segment in 2023 and specifically thinking about new product launch opportunities. If there's anything you can highlight in terms of date certain items or launches with certainty pursuant to settlements and then maybe specifically just some of the complex generics that could enter the equation in 2023. I know we've -- I feel like we've been talking about teriparatide and cyclosporine for 3 presidential administrations here. And obviously, the FDA has been slow on complex generics, but any additional clarity you could add there with respect to the new product dynamic in 2023 would be helpful.

也許我可以請 Sven 就最後一個問題跟進關於 2023 年北美仿製藥市場可能性範圍的問題，並特別考慮新產品的發布機會。如果有什麼你可以強調某些項目或根據定居點確定推出的日期，然後可能只是一些可能在 2023 年進入等式的複雜仿製藥。我知道我們已經 - 我覺得我們已經在這裡的 3 屆總統任期內一直在談論特立帕肽和環孢菌素。顯然，FDA 在復雜的仿製藥方面進展緩慢，但您可以在其中添加關於 2023 年新產品動態的任何額外說明都會有所幫助。

And then for Richard, outside of the reiteration of the company's prior long-term financial targets, wondering if the strategic review or the updated strategic plan, in fact, could modify any of those parameters and thinking specifically about the 2027 debt-to-EBITDA target of 2x. Certainly seems like financial markets, equity holders will be much more comfortable with a higher leverage ratio, 2.5x to 3x and if they were comfortable with the company's use of discretionary capital in terms of pursuing pipeline enhancement initiatives in additional strategic investments. So I'm wondering if there's maybe some flexibility, particularly with respect to that parameter would free up quite a bit of cash flow for reinvestment into pipeline and longer-term growth assets.

然後對於理查德來說，除了重申公司先前的長期財務目標之外，想知道戰略審查或更新的戰略計劃實際上是否可以修改這些參數中的任何一個，並特別考慮 2027 年債務與 EBITDA 的比值2x 的目標。當然看起來像金融市場，股權持有人會更願意接受更高的槓桿率，2.5 倍到 3 倍，如果他們對公司在額外戰略投資中尋求管道增強計劃方面使用可自由支配資本感到滿意。所以我想知道是否有一些靈活性，特別是關於該參數將釋放相當多的現金流用於對管道和長期增長資產的再投資。

Thanks for the 2 questions, Elliot, So look, I'll go in the order you deliver them. So I'll ask Sven to answer one and the almost complex generics approvals that you've been experiencing through the last 3 presidential campaign.

謝謝你提出的 2 個問題，埃利奧特，所以你看，我會按照你提出的順序進行。因此，我將請 Sven 回答您在過去 3 次總統競選中經歷過的幾乎複雜的仿製藥批准。

Yes. So the usual suspects, thanks for the question, Elliot. So U.S. generics this year, overall, we'll see a weak patent expiring year. So this year doesn't have a lot of, let's say, launches that are naturally driven by patent expiry dates. It will be more driven by FDA approvals and settlement entries. As you also pointed out, Humira, we already talked about. For TO, we received the [CRL] that we answered to the FDA. We are working with them closely to sort out this issue. Just as a reminder, this product has been launched many years ago in Europe already with EMA approval and we know how to manufacture it, of course. And I believe the product is high quality and that we will get the FDA around to give us approval.

是的。所以通常的嫌疑人，謝謝你的問題，埃利奧特。因此，今年美國仿製藥總體而言，我們將看到一個疲軟的專利到期年。所以今年沒有很多，比方說，由專利到期日自然驅動的發布。它將更多地受到 FDA 批准和結算條目的驅動。正如你也指出的那樣，修美樂，我們已經談過了。對於 TO，我們收到了我們向 FDA 答复的 [CRL]。我們正在與他們密切合作來解決這個問題。提醒一下，該產品多年前已在歐洲推出並獲得 EMA 批准，我們當然知道如何製造它。我相信該產品質量上乘，我們將獲得 FDA 的批准。

Then we have the reentry of REVLIMID, of course, due to our settlement date that is working on an annual cycle. So when we reenter this market with a higher volume allocation within the settlement with BMS. And then we have, of course, [Xulane], which is a new drug on the list for launch this year. And then I have a couple of other products that we say, prepared for launch, assuming that we get FDA approval. But since we have made some experiences with the FDA about how difficult it is to get complex generics approved. I don't want to give you a certain, let's say, now I think once we get approval, we will communicate more around that.

然後我們有 REVLIMID 的重新進入，當然，由於我們的結算日期是按年度週期工作的。因此，當我們在與 BMS 的結算中以更高的交易量分配重新進入這個市場時。然後我們當然有[Xulane]，這是今年上市的新藥。然後我有幾個其他產品，我們說，準備推出，假設我們獲得 FDA 批准。但是，由於我們與 FDA 取得了一些經驗，了解複雜仿製藥獲得批准的難度。我不想給你一個肯定，比方說，現在我認為一旦我們獲得批准，我們將圍繞它進行更多溝通。

But overall, I can say, let's say, complex generics are still quite attractive for us because if you analyze in the classical 80-20 analysis, our gross margin and the cash contribution within the generics portfolio, complex generics are certainly a major stabilizer in our business in North America. You also see that our price decline is quite stable in the base business. So that has improved over the last year, and we don't expect the organic changes in that space. So overall, I would say, U.S. generics will develop if we get all the approvals that we discuss on a regular basis in this call.

但總的來說，我可以說，複雜的仿製藥對我們仍然很有吸引力，因為如果你在經典的 80-20 分析中分析，我們的毛利率和仿製藥投資組合中的現金貢獻，複雜的仿製藥肯定是一個主要的穩定器我們在北美的業務。您還看到我們在基礎業務中的價格下降非常穩定。因此，這在去年有所改善，我們預計該領域不會發生有機變化。所以總的來說，我想說，如果我們獲得我們在本次電話會議中定期討論的所有批准，美國仿製藥將會發展。

Thank you, Sven. And then to answer your question about the paying down debts and the EBITDA target we gave in 2027 and flexibility around that, if I heard you correctly Elliot. So look, we're in the midst of doing our strategic review and understanding our plan going forward. And that's a strategy that's going to deliver growth. That's the whole point of putting that strategy together. I think what we think is important and what is the team has worked hard on is to get credibility around our debt and all the payment of it over the last few years. And so we don't want to squander that too quickly.

謝謝你，斯文。然後回答你關於償還債務和我們在 2027 年設定的 EBITDA 目標以及圍繞該目標的靈活性的問題，如果我沒聽錯的話，埃利奧特。所以看，我們正在進行戰略審查並了解我們的未來計劃。這是一種將帶來增長的戰略。這就是將該戰略整合在一起的全部意義所在。我認為我們認為重要的是，團隊努力工作的是在過去幾年中圍繞我們的債務和所有債務的支付獲得可信度。所以我們不想太快浪費掉它。

So I think as we work through the strategic review and understand the opportunities and the need for capital both within the company to reallocate resources to drive some of our pipeline on our end market products as well as to do some video now. We need to think about that. But I'd also like to say that I think we have the ability to pay down that debt in the fashion that we've outlined and still be able to have some capital to allocate to drive the company back to growth. But we're in the midst of that, but I appreciate your point of view and your question to challenge that. And we'll be able to give a bit more clarity on that this year.

因此，我認為，當我們通過戰略審查工作並了解公司內部的機會和資本需求時，可以重新分配資源以推動我們在終端市場產品上的一些管道以及現在製作一些視頻。我們需要考慮一下。但我還想說，我認為我們有能力以我們概述的方式償還債務，並且仍然能夠分配一些資本來推動公司恢復增長。但我們正處於其中，但我很欣賞你的觀點和你挑戰它的問題。今年我們將能夠對此進行更清晰的說明。

This is from the line of Chris Schott from JPMorgan.

這是來自摩根大通的 Chris Schott 的說法。

Just 2 for me. I guess, first, maybe, Eli, how should we be thinking about gross margins this year. I know you're targeting flat OpEx, but just maybe a little bit more color on the components of OpEx as we think about '23?

對我來說只有2個。我想，首先，也許，Eli，我們應該如何考慮今年的毛利率。我知道您的目標是持平 OpEx，但在我們考慮 23 年時，OpEx 的組成部分可能會有更多顏色？

And the second one was just kind of a bigger picture question on the biosimilar business. As you talked about this -- as this continues to ramp and it's an important growth driver for Teva. I guess there's a continued kind of partner-centric approach make the most sense for the company or would these be capabilities you would want to develop, I guess, to be more in-house over time as you think about kind of really trying to maximize the value of this opportunity.

第二個問題只是關於生物仿製藥業務的更大範圍的問題。正如你所說的那樣——隨著這種情況的持續增加，它是 Teva 的重要增長動力。我想有一種持續的以合作夥伴為中心的方法對公司最有意義，或者這些是你想要開發的能力，我想，隨著時間的推移，當你考慮真正試圖最大化這個機會的價值。

Thanks, Chris. Thanks for the question. So Eli, you take the first one and then I can chime in with a few on the second.

謝謝，克里斯。謝謝你的問題。所以 Eli，你拿第一個，然後我可以在第二個上加入一些。

Thanks Chris, for the question. So we end up; 22 around 54% gross margin. And actually, when we are looking on '23, we're going to see a bit higher, I would say, additional 0.3% and one of the things that we need to remember that the macroeconomic headwinds actually, overall, if you look on the numbers, it hit us around on our revenues to call it around $300 million with all the activities that we've already done and all those, I would say, optimization that were part of our long-term financial targets to expand our margin has helped us, as I mentioned in my prepared remarks, we partially offset the elements.

謝謝克里斯，提出這個問題。所以我們結束了； 22 毛利率約為 54%。實際上，當我們關注 23 年時，我們會看到更高一點，我想說，額外的 0.3% 和我們需要記住的一件事，即宏觀經濟逆風實際上，總體而言，如果你看這些數字對我們的收入產生了影響，將其稱為 3 億美元左右，我們已經完成了所有活動，我想說的是，優化是我們擴大利潤的長期財務目標的一部分。幫助我們，正如我在準備好的發言中提到的，我們部分抵消了這些因素。

Now there is also a kind of element on revenue mix, and you can actually see that the with the growth of AUSTEDO and as well on AJOVY and a few other elements that we are actually working on. We're going to see a very modest increase but not more to the level of 54.5% I would say, in '23, which means that our ability to keep the current level on the OpEx will stay the same and the residual amount will flow through the OP margin.

現在還有一種關於收入組合的元素，你實際上可以看到隨著 AUSTEDO 的增長以及 AJOVY 和我們實際正在研究的其他一些元素。我們將看到一個非常適度的增長，但不會超過 54.5% 的水平，我會說，在 23 年，這意味著我們保持 OpEx 當前水平的能力將保持不變，剩餘金額將流動通過 OP 保證金。

Thanks, Eli. So on the biosimilars. So I think the question, Chris, was around as we move forward, we see it as a growth driver. Is this continued partner strategy or not. So firstly, let me clarify that although we have a good and productive partnership with Alvotech, which is delivering a nice pipeline. We also have, I think, it's 6 in-house biosimilars that we've developed ourselves.

謝謝，伊萊。所以在生物仿製藥上。所以我認為這個問題，克里斯，在我們前進的過程中一直存在，我們將其視為增長動力。這是否是持續的合作夥伴策略。所以首先，讓我澄清一下，儘管我們與 Alvotech 建立了良好且富有成效的合作夥伴關係，但它提供了一條很好的管道。我認為，我們還有 6 種我們自己開發的內部生物仿製藥。

And going back to a comment I made on an earlier question. What I think is important with biosimilars is that we have a broad and deep pipeline that we can address most of these large biologics when they come off patent. And to do that, to do that effectively from a capital allocation point of view, I think it's a combination. It's a combination of partnering and it's a combination of doing some things in-house. And so that's what I see going forward. That combination, just to make sure we have the right pipeline and we're launching the products at the right time.

回到我對之前的問題所做的評論。我認為生物仿製藥的重要之處在於我們擁有廣泛而深入的管道，我們可以在這些大型生物製劑專利到期時解決其中的大部分問題。要做到這一點，要從資本配置的角度有效地做到這一點，我認為這是一種結合。這是合作的結合，也是內部做一些事情的結合。這就是我對未來的看法。這種結合，只是為了確保我們擁有正確的渠道，並在正確的時間推出產品。

And the last question is from Rishi Parekh from JPMorgan.

最後一個問題來自摩根大通的 Rishi Parekh。

I just want to confirm a few things and then talk about -- or ask a few questions on your balance sheet. With regards to your free cash flow, that 1.7 to 2.1, I want to confirm that, that includes the $450 million of opioid payments? Or is it a different number?

我只想確認幾件事，然後談談——或者問你資產負債表上的幾個問題。關於你的自由現金流，從 1.7 到 2.1，我想確認一下，這包括 4.5 億美元的阿片類藥物支付？或者它是一個不同的數字？

Yes, it's including.

是的，它包括。

Okay. Great. And then with regards to your maturities, if I heard you correctly, I think you said that you're going to address your '23, '24 and '25 maturities, which is different than what you have said at the JPMorgan conference. I was hoping that you could just walk us through what led to that change? Is it something related to your free cash flow or something related just to the interest rate environment, but I would love to just have you walk through that.

好的。偉大的。然後關於你的期限，如果我沒聽錯的話，我想你說過你將解決你的 23 年、24 年和 25 年的期限，這與你在摩根大通會議上所說的不同。我希望您能告訴我們是什麼導致了這種變化？它是與您的自由現金流有關還是僅與利率環境有關，但我很樂意讓您了解一下。

Yes. So when we actually set the market, you will appreciate that the interest rate environment is higher than what we expected to tender on our debt take, and that means that we will have an impact on our -- that will flow through impact on our free cash flow. This is one. The second thing is that as we move forward and we see ourselves now more inside of positive momentum with the opioid, we actually want to make sure that we have enough cushion to manage that liability. And coming back to your first question, and that's actually already embedded there.

是的。因此，當我們實際設定市場時，您會意識到利率環境高於我們預期的債務承擔，這意味著我們將對我們產生影響 - 這將通過影響我們的自由現金周轉。這是一。第二件事是，隨著我們向前邁進，我們現在看到自己更多地處於阿片類藥物的積極勢頭中，我們實際上想確保我們有足夠的緩衝來管理這種責任。回到你的第一個問題，這個問題實際上已經嵌入其中。

So we used to have kind of a 2.12, 1.9 range on the debt take, currently, the '23 is 2.1, '24 is 1.9. We're going to take it lower a bit in order to make sure that we have enough cushions there to manage it, and it will be part of the coming refinancing, which majority will be focused on the debt take of '25.

所以我們曾經有一個 2.12，1.9 的債務範圍，目前，'23 是 2.1，'24 是 1.9。我們將把它降低一點，以確保我們有足夠的緩衝來管理它，這將是即將到來的再融資的一部分，其中大部分將集中在 25 年的債務償還上。

And then with the drop-down in your AR financing next year to $500 million, one, can you walk us through why it's declining by $500 million next year? And is that also affecting your thoughts around how you're looking to address your debt maturities this year?

然後隨著明年你的 AR 融資下降到 5 億美元，第一，你能告訴我們為什麼它明年下降 5 億美元嗎？這是否也會影響您對今年如何解決債務到期問題的想法？

Yes. So I don't understand the drop on the AR for next year. Where you're actually considering that one? But I can mention the dynamics. This year, in terms of working capital, we were able to optimize our outstanding tables as well a DSO. And that actually offset part of inventory increase in order to support our production plan for mostly for the first half of the year.

是的。所以我不明白明年 AR 的下降。你實際上在哪裡考慮那個？但我可以提一下動態。今年，就營運資金而言，我們能夠優化我們的優秀表格和 DSO。這實際上抵消了部分庫存增加，以支持我們上半年的大部分生產計劃。

Yes. Sorry, I was just referring to the new AR facility that you entered into. I think it's $1 billion through November of this year, and then it drops to $500 million from November '23 onwards to November '25. And I was just hoping for an explanation behind that drop?

是的。抱歉，我只是指您進入的新 AR 設施。我認為到今年 11 月是 10 億美元，然後從 23 年 11 月到 25 年 11 月下降到 5 億美元。而我只是希望在下降背後得到解釋？

Yes. So actually, the facility is around $1 billion. We are not using the full of it. We use the 800 as an opportunity for us to be flexible on that program by actually initiating further enhancement on other elements under working capital that will allow us to be more flexible and you reduce that program going forward.

是的。所以實際上，該設施大約是 10 億美元。我們沒有使用它的全部。我們利用 800 作為一個機會，通過實際啟動對營運資金下其他要素的進一步增強，使我們能夠更加靈活，並且您可以減少該計劃的推進。

Okay. Great. I follow with my direct questions later.

好的。偉大的。稍後我會提出我的直接問題。

Thank you for your questions. I'd like to thank everybody for the questions and interest in the call today. And I'd like to also apologize for some of the technical issues at the start. That's always out of our control, but I appreciate you bearing with us. And on that, I'd like to close the call. Once again, thank you for your interest and look forward to talking to you on future calls.

謝謝你的問題。我要感謝大家在今天的電話會議中提出的問題和興趣。我還想為一開始的一些技術問題道歉。這始終是我們無法控制的，但我感謝您對我們的包容。關於這一點，我想結束通話。再次感謝您的關注，並期待在以後的電話中與您交談。

Thank you. This does conclude the conference for today. Thank you for participating, and you may now disconnect.

謝謝。今天的會議到此結束。感謝您的參與，您現在可以斷開連接。