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Operator
Operator
Good day, and thank you for standing by. Welcome to the Teva Second Quarter Financial Results Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, [Ron Mannix], Senior Vice President, Head of Investor Relations. Please go ahead.
美好的一天,感謝您的支持。歡迎參加 Teva 第二季度財務業績電話會議。 (操作員說明)請注意,今天的會議正在錄製中。我現在想將會議交給您今天的第一位發言人,[Ron Mannix],高級副總裁兼投資者關係主管。請繼續。
Kevin C. Mannix - SVP of IR
Kevin C. Mannix - SVP of IR
Thank you, Sandra. Thank you, everyone, for joining us today. We all have had an opportunity to review our press release, which was issued yesterday. 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. I am joined today on the call by Kare Schultz, Teva's CEO, Eliyahu Kalif, our CFO; and Sven Dethlefs, Head of North America business. We have today acquired a busy agenda. We will start the call with an update from Kare on the progress achieved on the operations front. This will be followed by cause and (inaudible) review of the second quarter business and financial results as well as the updated outlook for 2022.
謝謝你,桑德拉。謝謝大家,今天加入我們。我們都有機會回顧昨天發布的新聞稿。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副本。今天,Teva 首席執行官 Kare Schultz 和我們的首席財務官 Eliyahu Kalif 加入了我的電話會議;以及北美業務負責人 Sven Dethlefs。我們今天獲得了一個繁忙的議程。我們將首先從 Kare 更新運營方面取得的進展。隨後將對第二季度的業務和財務業績以及更新的 2022 年展望進行原因和(聽不清)審查。
And we will end the presentation for today's call with a strategy update from Kare and discussion of our new long-term financial targets. Please note that today's call will run approximately 70 minutes. Before we begin, please see our forward-looking statements disclaimer on Slide #2. Additional information regarding these statements and our non-GAAP financial measures is available on our earnings release and our SEC Form 10-K and 10-Q under Risk Factors. And with that, I will now turn the call over to Kare. Kare, if you would, please?
我們將以 Kare 的戰略更新和對我們新的長期財務目標的討論結束今天的電話會議。請注意,今天的通話將持續大約 70 分鐘。在開始之前,請參閱幻燈片 #2 上的前瞻性聲明免責聲明。有關這些報表和我們的非公認會計原則財務指標的更多信息,請參閱我們的收益發布和我們的風險因素下的 SEC 表格 10-K 和 10-Q。有了這個,我現在將把電話轉給 Kare。凱爾,如果你願意,好嗎?
Kare Schultz - President, CEO & Director
Kare Schultz - President, CEO & Director
Thank you, Ron. Welcome, everybody. It's a pleasure to update you on the opioid litigation. As you have seen in our release, we reached an agreement in principle with the working group of both the states, the tribes and the plaintiff lawyers representing the states and subdivisions and reach financial terms for a nationwide opioid settlement. We will be paying $4.25 billion over 13 years. This includes the already settled cases. As you've been seeing, we've settled a number of states during the last half year. We'll be paying $100 million for the trial spread -- also spread over 13 years. As you've seen in the settlements we've been doing on a state-by-state basis so far.
謝謝你,羅恩。歡迎大家。很高興向您介紹阿片類藥物訴訟的最新情況。正如您在我們的新聞稿中看到的那樣,我們與州、部落和代表州和分區的原告律師的工作組原則上達成協議,並就全國性阿片類藥物和解達成了財務條款。我們將在 13 年內支付 42.5 億美元。這包括已經解決的案件。正如你所看到的,我們在過去的半年裡已經解決了一些州。我們將為試用期支付 1 億美元——也分期為 13 年。正如您在迄今為止我們一直在逐州進行的定居點中所看到的那樣。
We have also committed to donate generic version of, Narcan, which is a product that can be used in case of overdosing to help people survive. We'll be donating these products over 10 years, and there will be the option for states to go for a cash value instead of the actual product donation. Of course, we're hopeful that many will accept the donation and in that way, help combat the opioid epidemic. We revised our provision to reflect all the details of the agreement we have in principle on a nationwide settlement. The agreement is contingent upon file documentation among the working group and us. And of course, like other big nationwide agreements, it's also predicated upon that we will need a certain participation from the states and subdivisions, which will be set forward in the final agreement.
我們還承諾捐贈仿製版本的 Narcan,這是一種可以在過量服用的情況下幫助人們生存的產品。我們將在 10 年內捐贈這些產品,並且各州可以選擇以現金價值代替實際的產品捐贈。當然,我們希望許多人會接受捐贈,從而幫助對抗阿片類藥物的流行。我們修改了我們的條款,以反映我們原則上就全國范圍內達成的協議的所有細節。該協議取決於工作組和我們之間的文件文件。當然,與其他大型全國性協議一樣,它也基於我們需要各州和分部的一定參與,這將在最終協議中提出。
The agreement is also contingent upon us reaching an agreement with Allergan with respect to any indemnification obligations and Allergan reaching a nationwide opioid settlement. Once the documentation is finalized, the nationwide agreement will need to be adopted by a sufficient number of plaintiffs, which would then result in the vast majority of opioid related claims and litigation by state subdivisions and Native-American tribes in the United States to be settled. There are no remaining trials currently scheduled against us in 2022 with the possible exception of the relief phase of the trial in New York opioid litigation.
該協議還取決於我們與 Allergan 就任何賠償義務達成協議,並且 Allergan 達成全國性的阿片類藥物和解協議。一旦文件最終確定,全國性協議將需要由足夠數量的原告通過,這將導緻美國各州分部和美洲原住民部落的絕大多數阿片類藥物相關索賠和訴訟得到解決.目前沒有安排在 2022 年對我們進行的剩餘審判,但紐約阿片類藥物訴訟中的救濟階段可能除外。
Additionally, Teva, New York state and it's subdivisions are engaged in ongoing settlement negotiations. We expect that the documentation for the nationwide settlement agreement will be finalized in the coming weeks, with the actual nationwide settlement sign-on process for state subdivision and tribes to follow.
此外,紐約州梯瓦公司及其分支機構正在進行和解談判。我們預計全國和解協議的文件將在未來幾週內最終確定,隨後州分部和部落的實際全國定居簽署程序將遵循。
Next slide, please. Let me now turn to the second quarter and the financial highlights. Revenues came in at $3.8 billion. Adjusted EBITDA came in at $1.1 billion. The GAAP diluted loss per share was $0.21. The non-GAAP diluted EPS was $0.68, and the free cash flow came in at $301 million. We continue to reduce our debt and the debt has now been reduced to $20 billion. Our 2022 revenue outlook has been revised, mainly due to continued foreign exchange headwinds. We've seen the dollar appreciate significantly during the last year against the euro as much as 14%, 15%. Our guidance for operating income, EBITDA, EPS and free cash flow remains unchanged.
請下一張幻燈片。現在讓我談談第二季度和財務亮點。收入為 38 億美元。調整後的 EBITDA 為 11 億美元。 GAAP 攤薄後每股虧損為 0.21 美元。非公認會計原則攤薄後每股收益為 0.68 美元,自由現金流為 3.01 億美元。我們繼續減少債務,現在債務已減少到 200 億美元。我們對 2022 年的收入前景進行了修訂,主要是由於持續的外匯逆風。去年,我們看到美元兌歐元大幅升值 14%、15%。我們對營業收入、EBITDA、每股收益和自由現金流的指導保持不變。
On the business side, we will comment on AUSTEDO and AJOVY in the coming slides, but I'd like to point out that North America Generics had a strong quarter with good contribution from the generic version of f Revlimid, but also continued strong sales of Epipen as well as the biosimilar Truxima, which is the biosimilar version of Rituxan, where we still have a high market share. In Europe, we also saw a very strong volume uptake of both our generics and OTC. And we actually saw that the revenue in local currency was up 12%. So we are seeing a, I would say, normalization of volumes following the COVID-19 restrictions that have been lifted. We also had a biosimilar product launch in the U.K., the Biosimilar to Lucentis.
在業務方面,我們將在接下來的幻燈片中對 AUSTEDO 和 AJOVY 進行評論,但我想指出,北美仿製藥的季度表現強勁,f Revlimid 仿製藥的貢獻很大,而且繼續強勁的銷售Epipen 以及生物仿製藥 Truxima,它是 Rituxan 的生物仿製藥版本,我們仍然擁有很高的市場份額。在歐洲,我們還看到我們的仿製藥和非處方藥的銷量都非常強勁。我們實際上看到以當地貨幣計算的收入增長了 12%。因此,我想說,在取消 COVID-19 限制之後,我們看到了交易量的正常化。我們還在英國推出了生物仿製藥產品,即 Lucentis 的生物仿製藥。
Next slide, please. If you look at the revenue development here, then you need to be aware that we report this in ongoing currency, ongoing realized currencies, which basically means that when you're comparing to Q2 '21, we do see a decline in U.S. dollar terms. Had we reported it in the local currencies, then the revenue would basically be flat. And that means that in Europe, we do not see in local currency a decline we rather see a small increase. And in North America, we see stable revenues as well as international markets. In international markets, of course, there has been a negative influence on our revenues in Ukraine due to the conflict there. But overall, the revenue in international markets is in line with expectations.
請下一張幻燈片。如果您查看此處的收入發展,那麼您需要注意我們以持續貨幣、持續已實現貨幣報告這一數字,這基本上意味著當您與 21 年第二季度相比時,我們確實看到美元匯率有所下降.如果我們以當地貨幣報告,那麼收入將基本持平。這意味著在歐洲,我們沒有看到當地貨幣下跌,而是看到了小幅上漲。在北美,我們看到穩定的收入以及國際市場。當然,在國際市場上,由於那裡的衝突,我們在烏克蘭的收入受到了負面影響。但總體而言,國際市場的收入符合預期。
Next slide, please. AUSTEDO continues to grow very nicely. We see a continuous growth in the TRx and in patient numbers. On the revenue side, we have some quarterly ups and downs, as we've always had, but we are happy about the revenue in the second quarter, and we reconfirm our outlook for the full year, where we expect to sell $1 billion.
請下一張幻燈片。 AUSTEDO 繼續發展得非常好。我們看到 TRx 和患者人數持續增長。在收入方面,我們一直有一些季度起伏,但我們對第二季度的收入感到高興,我們再次確認了全年的展望,預計銷售額將達到 10 億美元。
Next slide, please. AJOVY is also doing very fine. You can see here how the scripts are continuing to grow in the U.S. And you can also see how the market share in Europe continues to grow. We now have a market share of above 30% in Europe, and we have an aim now of 1/3 of the markets. We are now #2 in the European market coming from a late launch position is #3. We strongly believe that the efficacy and safety of AJOVY is very, very good also compared to competition, and we are optimistic about the future sales growth of this key product.
請下一張幻燈片。 AJOVY 也做得很好。您可以在這裡看到腳本如何在美國繼續增長,您還可以看到歐洲的市場份額如何繼續增長。我們現在在歐洲的市場份額超過 30%,我們現在的目標是佔據 1/3 的市場。我們現在在歐洲市場排名第二,因為發佈時間較晚,排名第三。我們堅信 AJOVY 的療效和安全性與競爭對手相比也非常非常好,我們對這一關鍵產品的未來銷售增長持樂觀態度。
Next slide, please. The margin continues to evolve positively, along with our operational plans to optimize manufacturing, optimize our commercial operation. You see here that the first half year margin is above the first half year margin last year. And the reason why we have a difference between the first half year margin and the full year margin is that we always had a strong fourth quarter in terms of revenue for a lot of practical reasons, and that means that we still expect to see an uptick for the full year compared to the first half and means that we are on our way to hit the long-term financial target for 2023 of 28% as operating margin.
請下一張幻燈片。隨著我們優化製造、優化商業運營的運營計劃,利潤率繼續積極發展。你在這裡看到上半年的利潤率高於去年上半年的利潤率。上半年利潤率和全年利潤率之間存在差異的原因是,出於許多實際原因,我們在第四季度的收入一直表現強勁,這意味著我們仍然希望看到上升全年與上半年相比,這意味著我們正在努力實現 2023 年 28% 的長期財務目標作為營業利潤率。
Next slide, please. The debt, as I alluded to earlier, continues to decline. We now down to $20 billion. Of course, we won't stop here. We will continue to drive down debt, and I'll be commenting later on what our long-term target will be for the debt development. We are very committed to our patients. As you know, we serve around 200 million patients every day, but we also try to serve these underprivileged people around the world with medicine because that's what we can do to help people. And here, you can see some examples around the world how we support vulnerable groups with mental health, with oncology treatment in both Africa, North America, Europe.
請下一張幻燈片。正如我之前提到的,債務繼續下降。我們現在降至 200 億美元。當然,我們不會止步於此。我們將繼續壓低債務,稍後我將評論我們的債務發展的長期目標。我們非常致力於我們的患者。如您所知,我們每天為大約 2 億患者提供服務,但我們也嘗試為世界各地的這些弱勢群體提供藥物,因為這是我們可以幫助人們所做的事情。在這裡,您可以看到世界各地的一些例子,我們如何支持弱勢群體的心理健康,以及在非洲、北美和歐洲的腫瘤治療。
And if you're interested in this, then there's a lot more information on all these programs on our website as part of our ESG reporting, where you can also see all the things we're doing to meet the targets we've set for our bonds, our sustainability-linked bonds where we've targets both for access and for climate. With this, I'll hand over to Eliyahu Kalif, who will comment on the numbers for (inaudible).
如果您對此感興趣,那麼作為我們 ESG 報告的一部分,我們網站上會提供有關所有這些計劃的更多信息,您還可以在其中看到我們為實現我們設定的目標所做的所有事情我們的債券,我們與可持續發展相關的債券,我們的目標是准入和氣候。有了這個,我將交給 Eliyahu Kalif,他將對(聽不清)的數字發表評論。
Eliyahu Sharon Kalif - Executive VP & CFO
Eliyahu Sharon Kalif - Executive VP & CFO
Thank you, Kare, and good morning and good afternoon to everyone. I will begin a review of the second quarter of 2022 financial results on Slide 15, starting with our GAAP performance. Revenues in the second quarter of 2022 were $3.8 billion, representing a decrease of 3% compared to Q2 2021. In local currency terms, revenue increased by 1% compared to the second quarter of 2021. This increase was mainly due to higher revenues from generic products in Europe and North America, partially offset by lower revenue from COPAXONE and BENDEKA/TREANDA in North America. We saw higher demand for generic and OTC products in Europe, mainly resulting from the removal of restrictions related to the COVID-19 pandemic, together with a higher revenue from generic product launches.
謝謝你,Kare,大家早上好,下午好。我將在幻燈片 15 上開始審查 2022 年第二季度的財務業績,從我們的 GAAP 表現開始。 2022 年第二季度的收入為 38 億美元,比 2021 年第二季度下降 3%。按當地貨幣計算,收入比 2021 年第二季度增長 1%。這一增長主要是由於仿製藥收入增加歐洲和北美的產品,部分被北美 COPAXONE 和 BENDEKA/TRANDA 的收入下降所抵消。我們看到歐洲對仿製藥和非處方藥產品的需求增加,這主要是由於取消了與 COVID-19 大流行相關的限制,以及仿製藥產品推出的收入增加。
The increase in generics revenue in North America was mainly related to the revenue from the generic version of Revlimid. In Q2 2022, we recorded a GAAP operating loss of $949 million compared to operating income of $582 million in Q2 2021, GAAP net loss of $232 million compared to the net income of $207 million in Q2 2021 and a GAAP loss per share of $0.21 compared to the earnings per share of $0.19 in the same period a year ago. The significant year-over-year decline was mainly driven by goodwill impairment charges, which I will discuss in the next slide. It was also driven by higher legal settlement expenses related to an update of the estimated settlement provision recorded in connection with the remaining office cases, as Kare just mentioned.
北美仿製藥收入的增長主要與仿製藥 Revlimid 的收入有關。在 2022 年第二季度,我們的 GAAP 營業虧損為 9.49 億美元,而 2021 年第二季度的營業收入為 5.82 億美元,GAAP 淨虧損為 2.32 億美元,而 2021 年第二季度的淨收入為 2.07 億美元,GAAP 每股虧損為 0.21 美元去年同期每股收益為 0.19 美元。同比大幅下降主要是由商譽減值費用驅動的,我將在下一張幻燈片中討論。正如 Kare 剛剛提到的,這也是由於更新了與剩餘辦公室案件有關的估計和解準備金相關的法律和解費用增加。
Foreign exchange rate movements during the second quarter of 2022, net of hedging effects negatively impacted revenue and GAAP operating income by $162 million and $6 million, respectively, compared to the second quarter of 2021. This was a result of the impact of a stronger U.S. dollar, especially versus the euro. In the second quarter of 2022, approximately 47% of our revenue come from sales denominated in non-U.S. dollar currency.
與 2021 年第二季度相比,扣除對沖效應後,2022 年第二季度的匯率變動對收入和 GAAP 營業收入的負面影響分別為 1.62 億美元和 600 萬美元。這是由於美國經濟走強的影響。美元,尤其是對歐元。 2022 年第二季度,我們約 47% 的收入來自以非美元貨幣計價的銷售。
Turning to Slide 16. I -- you can see that the net non-GAAP adjustments in the second quarter of 2022 were $986 million versus $444 million in Q2 2021. The majority of this amount was a result of a $745 million goodwill impairment charge that was booked to our international market and Teva APR reporting unit due to increased discounts and country-risk premium rates. Additional notable non-GAAP adjustments include legal settlements of $729 million, mainly due to an update of the estimated opioid settlement provision. In Q2 2022, according to the agreement in principle that Kare mentioned, the overall [opioid] provision was updated to $3.2 billion to reflect the discounted cash flow for all elements of the nationwide legal settlement on the assumption that we finalize the relevant outstanding terms and get a full participation.
轉到幻燈片 16。您可以看到,2022 年第二季度的非公認會計原則淨調整為 9.86 億美元,而 2021 年第二季度為 4.44 億美元。其中大部分是 7.45 億美元商譽減值費用的結果由於折扣和國家風險溢價率增加,我們的國際市場和 Teva APR 報告單位被預訂。其他值得注意的非公認會計原則調整包括 7.29 億美元的法律和解,主要是由於更新了估計的阿片類藥物和解條款。在 2022 年第二季度,根據 Kare 提到的原則性協議,假設我們最終確定相關未決條款和得到充分參與。
Non-GAAP adjustment also includes amortization of purchased intangible assets, totaling $212 million, the majority of which is included in the cost of goods sold. Corresponding tax effects includes a portion of realization of losses related to an investment in our -- one of our U.S. subsidiaries.
非公認會計原則調整還包括購買無形資產的攤銷,總額為 2.12 億美元,其中大部分包含在銷售成本中。相應的稅收影響包括與我們的美國子公司之一的投資相關的部分實現損失。
Moving to Slide 17 for a review of our non-GAAP performance. I have already discussed our second quarter revenue, which totaled approximately $3.8 billion. Now let's move down the P&L and look at the margin. Our non-GAAP gross profit margin improved to 54.4% compared to 53.3% in Q2 2021. Despite 1% quarter-over-quarter decline in non-GAAP gross profit, the increase in non-GAAP gross profit margin was mainly driven by the favorable mix of products in our Europe segment and the positive impact of hedging activities, partially offset by lower revenue from COPAXONE and the change in the mix of products in our North America segment. Our non-GAAP operating margin in Q2 2022 was 26.9% versus 26.4% in Q2 2021. This increase was driven mainly by a lower spend base, which I will discuss in the next slide. We ended the quarter with a non-GAAP earnings per share of $0.68 compared to $0.59 in Q2 2021, mostly due to lower financial expenses and income taxes.
移至幻燈片 17 以查看我們的非公認會計原則表現。我已經討論了我們第二季度的收入,總額約為 38 億美元。現在讓我們向下移動 P&L 並查看保證金。我們的非美國通用會計準則毛利率從 2021 年第二季度的 53.3% 提高到 54.4%。儘管非美國通用會計準則毛利率環比下降 1%,但非美國通用會計準則毛利率的增長主要是由於有利的我們歐洲分部的產品組合和對沖活動的積極影響,部分被 COPAXONE 的收入下降和我們北美分部的產品組合變化所抵消。我們在 2022 年第二季度的非公認會計準則營業利潤率為 26.9%,而 2021 年第二季度為 26.4%。這一增長主要是由於支出基數較低,我將在下一張幻燈片中討論這一點。我們在本季度末的非公認會計準則每股收益為 0.68 美元,而 2021 年第二季度為 0.59 美元,主要是由於財務費用和所得稅降低。
Now let's take a look to our spend base on Slide 18. We see that our quarterly spend base declined by $110 million, although it increased by $41 million net of FX, looking at our total spend base for the first half of 2022, it declined by $367 million or $142 million net of FX. We continue with our ongoing efforts to transform our global operational network and ongoing activities on the management of operating expenses. We expect the overall annual spend base to remain well below $12 billion as we continue to focus our efforts on reducing and optimizing our cost of goods sold.
現在讓我們看看我們在幻燈片 18 上的支出基數。我們看到我們的季度支出基數下降了 1.1 億美元,儘管扣除外匯後增加了 4100 萬美元,但從 2022 年上半年的總支出基數來看,它下降了3.67 億美元或 1.42 億美元(扣除外匯)。我們將繼續努力改變我們的全球運營網絡和正在進行的運營費用管理活動。我們預計整體年度支出基數將遠低於 120 億美元,因為我們將繼續努力降低和優化我們的銷售成本。
As I mentioned last quarter, these ongoing efforts are expected to continue to help us partially mitigate the global macroeconomic headwinds, including inflation and higher cost of labor and eventually leads to stabilize our operating margin above the level of 27% in 2022 with the ultimate goal of 28% operating margin by the end of 2023.
正如我上個季度提到的,這些持續的努力預計將繼續幫助我們部分緩解全球宏觀經濟逆風,包括通貨膨脹和更高的勞動力成本,並最終使我們的營業利潤率在 2022 年穩定在 27% 以上的水平,最終目標是到 2023 年底,營業利潤率為 28%。
Turning to free cash flow on Slide 19. Our free cash flow in the second quarter of 2022 was $201 million. As I've mentioned in the past, Teva's free cash flow tends to face headwinds at the start of the year. In addition, we faced challenges due to the timing of certain items related to our working capital as a result of operational ramp-ups in relation to our annual production plan. The decrease in our free cash flow in the second quarter of 2022 resulted mainly from lower cash flow from operating activities as well as lower proceeds from the sales of assets, which we saw in Q2 2021. This decrease in cash flow from operating activities was mainly due to payments related to legal settlements in the second quarter of 2022, partially offset by an increase in accounts payable.
轉向幻燈片 19 上的自由現金流。我們在 2022 年第二季度的自由現金流為 2.01 億美元。正如我過去提到的,梯瓦的自由現金流在年初往往面臨逆風。此外,由於與我們的年度生產計劃相關的運營提升,我們面臨與營運資金相關的某些項目的時間安排的挑戰。我們在 2022 年第二季度的自由現金流減少主要是由於我們在 2021 年第二季度看到的經營活動現金流減少以及資產出售收益減少。經營活動現金流的減少主要是由於 2022 年第二季度與法律和解相關的付款,部分被應付賬款的增加所抵消。
Today, we are reaffirming our 2022 free cash flow guidance, which we initially provided in February. Our 2022 free cash flow is expected to be in the range of $1.9 billion to $2.2 billion. We expect our free cash flow to pick up during the second half of the year as we continue to drive working capital improvement. We remain on track to achieve our objective of 80% or greater free cash flow conversion by the end of '23 as part of our long-term financial target.
今天,我們重申我們最初在 2 月份提供的 2022 年自由現金流指導。我們 2022 年的自由現金流預計將在 19 億美元至 22 億美元之間。隨著我們繼續推動營運資金的改善,我們預計我們的自由現金流將在下半年回升。作為我們長期財務目標的一部分,我們仍有望在 23 年底之前實現 80% 或更高的自由現金流轉換的目標。
Turning to Slide 20. Our net debt at the end of Q2 2022 was $20 billion compared to $20.9 billion at the end of 2021. The decrease in our gross debt related to the bond maturities paid in Q2 2022 as well as exchange rate fluctuation, our net debt-to-EBITDA ratio decrease coming in at 1.16x for Q2 2022. We expect it to further decline as we continue to make progress towards our 2023 targets. Debt reduction continues to be our primary focus and main use of cash. Upcoming maturities include $1.1 billion in the remainder of 2022, out of which [CHF 250 million], which equivalent to $260 million will be repaid tomorrow at maturity.
轉到幻燈片 20。我們在 2022 年第二季度末的淨債務為 200 億美元,而在 2021 年末為 209 億美元。與 2022 年第二季度支付的債券到期以及匯率波動有關的總債務減少,我們的2022 年第二季度的淨債務與 EBITDA 比率下降 1.16 倍。我們預計隨著我們繼續朝著 2023 年的目標取得進展,該比率將進一步下降。減債仍然是我們的主要關注點和現金的主要用途。即將到期的包括 2022 年剩餘時間內的 11 億美元,其中 [2.5 億瑞士法郎],相當於 2.6 億美元,將於明天到期償還。
So now turning to our non-GAAP financial outlook for 2022 on Slide 21. As you can see, we continue to see strong foreign exchange headwinds affecting our results. At current rates, we still expect foreign exchange fluctuation to have an unfavorable impact on revenue and therefore, we believe that consistent with what we had communicated in May, at this time, it's also prudent to adjust our guidance range for full year revenue from the previous range of $5.4 billion to $16 billion to the new range of $15 billion to $15.6 billion. This lowers the midpoint of our range by $400 million.
因此,現在在幻燈片 21 上轉向我們對 2022 年非公認會計原則的財務展望。如您所見,我們繼續看到強大的外匯逆風影響我們的業績。按照目前的匯率,我們仍然預計外匯波動會對收入產生不利影響,因此,我們認為,與我們在 5 月份所傳達的一致,此時調整我們對全年收入的指導範圍也是謹慎的。從之前的 54 億美元到 160 億美元的範圍,到新的 150 億美元到 156 億美元的範圍。這將我們範圍的中點降低了 4 億美元。
The new range includes an adjustment to our full year expectation of global sales of COPAXONE, of which we're lowering our guidance by $50 million to $700 million due to increasing generic competition in the United States and the availability of alternative therapies as well as continuing effect of foreign exchange fluctuation. Our non-GAAP tax rate in the second quarter of 2022 was mainly affected by the realization of losses related to an investment or in one of our U.S. subsidiaries. This led us to update our non-GAAP tax rate guidance from the previous range of 18% to 19% to the revised range of 13% to 14%. For other key 2022 financials, operating income, EBITDA, earnings per share and free cash flow, we are reaffirming the range provided in February as we continue to expect a gradual pickup in the second half of the year.
新系列包括對我們對 COPAXONE 全球銷售額全年預期的調整,由於美國仿製藥競爭的加劇和替代療法的可用性以及持續匯率波動的影響。我們在 2022 年第二季度的非公認會計原則稅率主要受到與投資或我們的一家美國子公司相關的損失實現的影響。這導致我們將我們的非 GAAP 稅率指引從之前的 18% 至 19% 的範圍更新為修訂後的 13% 至 14% 的範圍。對於其他關鍵的 2022 年財務、營業收入、EBITDA、每股收益和自由現金流,我們重申 2 月份提供的範圍,因為我們繼續預計下半年將逐步回升。
This concludes my review of several results for the second quarter of 2022. And now I will move back to Kare to discuss our strategy update in our 2027 long-term financial targets. Over to you, Kare.
我對 2022 年第二季度的幾項業績的回顧到此結束。現在我將回到 Kare,討論我們在 2027 年長期財務目標中的戰略更新。交給你了,凱爾。
Kare Schultz - President, CEO & Director
Kare Schultz - President, CEO & Director
Thank you, Eli. It's a pleasure to share with you our strategy update and our new long-term financial targets. If we start by looking a little back on the background for our current targets, and they were set, as you know, developed by management and the Board at the end of '17, beginning of 2018 in order to create a 5-year outlook for how to stabilize the business. In the meantime, the opioid litigation grew in complexity and size. But I'm very happy that we today can announce the agreement in principle, which basically is the beginning of putting this behind us. We've also, in those 5 years, had a huge debt to handle, and we've been paying it down consistently, as you've seen in all our presentations also today.
謝謝你,伊萊。很高興與您分享我們的戰略更新和新的長期財務目標。如果我們首先回顧一下我們當前目標的背景,如您所知,這些目標是由管理層和董事會在 17 年底、2018 年初制定的,以創建 5 年展望關於如何穩定業務。與此同時,阿片類藥物訴訟的複雜性和規模都在增加。但我很高興我們今天可以原則性地宣布協議,這基本上是我們把它拋在腦後的開始。在這 5 年裡,我們也有一筆巨額債務需要處理,而且我們一直在償還債務,正如您在今天的所有演講中所看到的那樣。
Actually, from a cash point of view, the last 4 years, we paid $18 billion to the bondholders in the form of debt reduction and interest payments. And of course, we will continue to do so, which means that we will now be taking the debt below $20 billion, and we'll continue to see a reduction of it. The way we've done it is, of course, partly by a very strong focus on cash flow and optimizing the business. And if you compare it to 2017, then the annual spend base is down by nearly $5 billion on an annual basis. And we've been able to generate consistently more than $2 billion in cash every year, and we expect to continue to do so going forward. The way we've done it is really by optimizing the business from the beginning, we have created a unified organizational structure.
實際上,從現金的角度來看,過去 4 年,我們以減債和支付利息的形式向債券持有人支付了 180 億美元。當然,我們將繼續這樣做,這意味著我們現在將把債務降至 200 億美元以下,而且我們將繼續看到它的減少。當然,我們這樣做的方式部分是由於非常關注現金流和優化業務。如果將其與 2017 年進行比較,那麼每年的支出基數每年下降近 50 億美元。而且我們每年能夠持續產生超過 20 億美元的現金,並且我們希望在未來繼續這樣做。我們這樣做的方式實際上是從一開始就優化業務,我們創建了一個統一的組織結構。
It's the one ever concept we call it basically meaning that everybody works together in order to optimize the synergies in the organization between generics, OTC, specialty between all the different sites, but it also includes a dramatic reduction of our footprint through consolidation. One example here is that we've gone from having 80 manufacturing sites to around 53. And we have operational plans for further reductions, reducing with around 10 sites over the coming years. The same kind of numbers, you will see if you look at the number of office locations, if you look at the number of R&D sites. So all in all, we've had a dramatic consolidation of the business leading to more efficiencies and helping us to generate the cash and the earnings every year.
這是我們稱之為的一個概念,基本上意味著每個人共同努力,以優化仿製藥、OTC、所有不同站點之間的專業之間的組織協同效應,但它還包括通過整合顯著減少我們的足跡。這裡的一個例子是,我們已經從 80 個生產基地減少到大約 53 個。我們制定了進一步減少生產基地的運營計劃,未來幾年將減少大約 10 個生產基地。同樣的數字,你看辦公地點的數量,你看研發地點的數量。總而言之,我們對業務進行了戲劇性的整合,從而提高了效率,並幫助我們每年產生現金和收益。
Now if you look at the next slide, you will see that the foundation of our business is unchanged compared to how we formulated it back in 2018. Our mission is to be a global leader in generics and biopharmaceuticals, improving the lives of patients. And our patient focus, like I mentioned earlier, is really the key, you could say, (inaudible) of the company, the key reason why we are here, we are here to help patients with medicines, be it generic medicines, be it OTC, be it new innovative medicines. And we help a lot of people. Roughly, we support around 200 million patients every day with all kind of different products across a very broad geographical range of countries and across a very broad range of products.
現在,如果您看下一張幻燈片,您會發現與我們在 2018 年制定業務的方式相比,我們的業務基礎沒有改變。我們的使命是成為仿製藥和生物製藥領域的全球領導者,改善患者的生活。就像我之前提到的,我們對患者的關注確實是關鍵,你可以說,(聽不清)公司,我們在這裡的關鍵原因,我們在這裡幫助患者使用藥物,無論是仿製藥,還是非處方藥,無論是新的創新藥物。我們幫助了很多人。粗略地說,我們每天為大約 2 億名患者提供各種不同的產品,涵蓋非常廣泛的國家地理範圍和非常廣泛的產品範圍。
We have core values, which I won't comment in detail, but these are unchanged, and they secure that we have high employee retention. It secures that we led our lives in an ethical way and secures that we stay in compliance.
我們有核心價值觀,我不會詳細評論,但這些價值觀沒有改變,它們確保我們有很高的員工保留率。它確保我們以合乎道德的方式過我們的生活,並確保我們保持合規。
If we move to the next slide, then you can see here that our strategic focus is really to continue to be leaders in generics to build a uniquely strong position biosimilar and in specific areas to continue to drive our specialty business with new innovative products and with further penetration of the great products that we have already launched. If we talk about the generics and look at the next slide, then you can always debate what is the sort of fundamental business model of generics. And the fundamental business model is, of course, very, very simple. Innovative products are developed all the time. They've launched some are very successful. Eventually, the patent expires and you get generic competition. So you would say what feeds the generic market is the value of products going off patent.
如果我們轉到下一張幻燈片,那麼您可以在這裡看到,我們的戰略重點是繼續成為仿製藥的領導者,以建立獨特的強大地位的生物仿製藥,並在特定領域繼續通過新的創新產品推動我們的專業業務,並進一步滲透我們已經推出的優秀產品。如果我們談論泛型並看下一張幻燈片,那麼您總是可以爭論什麼是泛型的基本商業模式。當然,基本的商業模式非常非常簡單。創新產品一直在開發。他們推出了一些非常成功的產品。最終,專利到期,您將獲得仿製藥競爭。所以你會說為仿製藥市場提供食物的是專利失效的產品的價值。
This is a very simple overview showing you how many products went off patent in the year '17 to '21. So in a 5-year period, roughly $110 billion. And you can see the mix between small molecules and biologics, 86 billion small molecules, 25 billion biologics. And you've heard me say many, many times that there's a gradual shift in the marketplace where more and more new innovative therapies are biologics. And therefore, there's also a gradual shift in which products go off patent. And this is very clearly illustrated here. This is the IQVIA forecast for the next 5 years, so '22 to '26. And you can see here that we are talking about near the $200 billion going off patent. And now it is like 120 small molecules, [70] biologics. So the biologics are getting close to being 50% of what goes off patent.
這是一個非常簡單的概述,向您展示了 17 年至 21 年有多少產品申請專利。所以在 5 年內,大約 1100 億美元。你可以看到小分子和生物製劑之間的混合,860 億個小分子,250 億個生物製劑。你已經聽我說過很多很多次了,市場正在逐漸轉變,越來越多的新創新療法是生物製劑。因此,專利失效的產品也在逐漸轉變。這一點在這裡得到了非常清楚的說明。這是 IQVIA 對未來 5 年的預測,所以是 '22 到 '26。你可以在這裡看到,我們正在談論接近 2000 億美元的專利到期。現在它就像 120 個小分子,[70] 生物製劑。因此,生物製劑接近專利的 50%。
If you do a projection further out, it gets a little more uncertain how revenues would actually be of the different products. But my prediction is if you do the next 5 years, you will be close to 50-50 between small molecules and biologics. And the value will be even bigger than it is for this 5-year period. So the short message here is there's plenty of business to be made in small molecules going off patent, having generic versions being launched, but also in biologics going off patent and having biosimilars being launched.
如果您進行更遠的預測,則會更加不確定不同產品的實際收入如何。但我的預測是,如果你在接下來的 5 年裡做,你將在小分子和生物製劑之間接近 50-50。並且價值將比這 5 年期間更大。因此,這裡的短信息是,在小分子專利到期、仿製藥上市、生物製劑專利到期和生物仿製藥上市方面有很多業務。
If we just look at the next slide, then this is another way to look at it. This is the sort of prediction for the total generic market worldwide. And you can see it's a huge market, and it's predicted to grow around 4% on an annual basis.
如果我們只看下一張幻燈片,那麼這是另一種看待它的方式。這是對全球整個仿製藥市場的預測。你可以看到這是一個巨大的市場,預計每年增長4%左右。
Now if you look at the next slide, we try to get a picture here of why we are the leading generic company in the world and what you need to do to stay the leading company. And of course, one of the things you need to do, you need to address by far the majority of the $400 billion that's going off patent over the next 10 years. And you do that by having a lot of projects, of course. So we have more than 1,000 projects covering 80% of what's going off patent. And that's really our guidance internally. We can't cover everything. There will be many products too many projects, but we want to cover 80% of the world value going off patent. That means you need to have a full range of technologies.
現在,如果您看下一張幻燈片,我們試圖在這裡了解為什麼我們是世界領先的仿製藥公司,以及您需要做些什麼才能保持領先地位。當然,您需要做的其中一件事是,您需要解決在未來 10 年中將失去專利的 4000 億美元中的大部分。當然,你可以通過很多項目來做到這一點。因此,我們有 1,000 多個項目,涵蓋了 80% 的專利問題。這確實是我們內部的指導。我們無法涵蓋所有內容。產品多,項目多,但我們要覆蓋全球80%的專利價值。這意味著您需要擁有全方位的技術。
Some of them simple, some of them very complex technologies, including things such as inhalers, patches, long-acting injectables, sterile injectables, all kind of different technology platforms for doing pharmaceutical products. It also means that you need to be fast because a lot of the value is by being first to file in the U.S. and by launching early in Europe so that you get a good market share and a good position within the generic space for whatever product that goes off patent. And it also in order to be profitable, it means that you need to continue to optimize your manufacturing footprint and your R&D footprint. And we are doing that by global integration capability. You need to make sure that you have efficient factories that can produce for the whole world.
其中一些很簡單,其中一些非常複雜的技術,包括吸入器、貼片、長效注射劑、無菌注射劑等各種用於生產藥品的不同技術平台。這也意味著您需要快速,因為很多價值在於首先在美國提交申請並在歐洲儘早推出,這樣您就可以獲得良好的市場份額和在通用領域內的任何產品的良好位置專利失效。而且為了盈利,這意味著您需要繼續優化您的製造足跡和研發足跡。我們正在通過全球整合能力做到這一點。您需要確保擁有可以為全世界生產的高效工廠。
Now we have all these elements. We are continuing to improve them, and I'm 100% confident that we will stay the world leader in generics also going forward. Now a new thing in the marketplace over the last 5 years is really the growth of biosimilars. And this will continue to grow strongly, and it's very simple. Why is it growing? Because more and more biologics are going off patent. So as you saw before, when more and more products go off patent, of course, there's more and more business [to be had] by the cognize -- and in this case, it's biosimilar products. And we, of course, see that it's growing all over the world, including North America. And we recently saw how strong that market segment is with our big success with Truxima where we gained something around 25% volume share and saw very strong revenues already now accumulated more than $1 billion in revenues of Truxima.
現在我們有了所有這些元素。我們正在繼續改進它們,我 100% 相信我們將繼續保持世界仿製藥的領先地位。現在,過去 5 年市場上的一個新事物實際上是生物仿製藥的增長。這將繼續強勁增長,而且非常簡單。為什麼它在增長?因為越來越多的生物製劑正在申請專利。所以正如你之前看到的,當越來越多的產品申請專利時,當然會有越來越多的業務被認知——在這種情況下,它是生物仿製藥產品。當然,我們看到它在世界各地都在增長,包括北美。我們最近看到這個細分市場有多強大,我們在 Truxima 方面取得了巨大成功,我們獲得了大約 25% 的銷量份額,並且看到非常強勁的收入現在已經積累了超過 10 億美元的 Truxima 收入。
Now if we move to the next slide, then you can see there are some other skills that you need in order to be a leader in biosimilars. But in a way, it's not radically different. It's technologically a little bit different because you need, of course, again, to have the same strong portfolio. It's typically less products, less projects because each product in the biosimilar space or in the biopharmaceutical space are typically bigger. So you have biologics products today having the products that will sell $5 billion, $10 billion, $15 billion, $20 billion on a worldwide basis. And therefore, we have the same philosophy. We want to cover 80% of the value going off patent, but you can typically do that with less projects. The projects are somewhat more complex. So you need, you would say, a different set of technologies.
現在,如果我們轉到下一張幻燈片,那麼您會看到您需要一些其他技能才能成為生物仿製藥的領導者。但在某種程度上,它並沒有根本不同。它在技術上有點不同,因為你當然需要同樣強大的產品組合。它通常是更少的產品,更少的項目,因為生物仿製藥領域或生物製藥領域的每個產品通常都更大。因此,您今天擁有的生物製品產品將在全球範圍內銷售 50 億美元、100 億美元、150 億美元、200 億美元。因此,我們有相同的理念。我們希望覆蓋 80% 的專利價值,但您通常可以通過較少的項目來做到這一點。這些項目稍微複雜一些。所以你會說,你需要一套不同的技術。
We have all those technologies, the full value chain in-house. We're expanding significantly in Germany on our capabilities here, our volume capacity. So we are very, very well focused on this going forward. There's a huge overlap between the practicalities of doing new patented innovative biopharmaceuticals and doing biosimilars. The whole, you say, the value chain of the actual manufacturing is actually the same. The future demand will be strong, and we believe we are very well-positioned to become a leader in biosimilars, both in U.S. and Europe and in the rest of the world.
我們擁有所有這些技術,內部擁有完整的價值鏈。我們正在德國顯著擴展我們的能力,即我們的容量。因此,我們非常非常專注於未來的發展。新的專利創新生物製藥和生物仿製藥的實用性之間存在巨大的重疊。整個,你說,實際製造的價值鏈其實是一樣的。未來的需求將十分強勁,我們相信我們完全有能力成為美國、歐洲和世界其他地區生物仿製藥的領導者。
Now let's take a look at our specialty pipeline. We have a focused specialty pipeline. We have 2 areas where we focus on most. That's in neuroscience and immunology -- and I won't go into details about the projects today that would take too long. But within the coming year, we will plan to have an R&D Day where our new Head of R&D as well as other members of management will tell you much more about the projects that we have here. But just there's a little teaser. You can see here we have projects, for instance, in MSA and in Parkinson's disease, an area where we have a strong tradition with the launch of AZILECT years ago and where we really have focused for many, many years. Movement disorders, as you know, is a key area for us, also with AUSTEDO in the marketplace.
現在讓我們來看看我們的專業管道。我們有一個專注的專業管道。我們有兩個我們最關注的領域。那是在神經科學和免疫學中——我不會詳細介紹今天需要太長時間的項目。但在接下來的一年中,我們將計劃舉辦一個研發日,屆時我們的新研發主管以及其他管理人員將向您詳細介紹我們在此開展的項目。但只是有一個小預告。你可以在這裡看到我們有項目,例如 MSA 和帕金森病,這是我們多年前推出 AZILECT 時擁有悠久傳統的領域,也是我們多年來一直專注的領域。如您所知,運動障礙是我們的一個關鍵領域,市場上的 AUSTEDO 也是如此。
So that's very, very exciting other exciting projects also in neuroscience. And in immunology, we have some very interesting (inaudible) projects in oncology, where you, as you know, you downregulate the effect of the immune stimulating agents so that it works only in the right spot. And that means that you overcome some of the safety hurdles. We are working also together with Takeda. They have in-licensed product in that category, and that's also doing very well going into Phase II. So a lot of exciting things that we'll get back to in more detail sometime during the coming year.
所以這是非常非常令人興奮的神經科學領域的其他令人興奮的項目。在免疫學方面,我們有一些非常有趣(聽不清)的腫瘤學項目,如您所知,您可以下調免疫刺激劑的作用,使其僅在正確的位置起作用。這意味著您克服了一些安全障礙。我們也在與武田合作。他們在該類別中擁有許可產品,並且在進入第二階段時也做得很好。因此,我們將在來年的某個時候更詳細地討論許多令人興奮的事情。
Now let's move to the next slide because as you know, I'd like to set out long-term targets, stick to them and make it relatively simple because otherwise, it gets too confusing. And if you change your targets all the time, it also gets too confusing. And I've been saying in the last year that we're getting close to the end of '23. So it's probably a good idea to share with all of you, analysts and investors, how do we see the longer-term future for Teva. And these are the new long-term targets for 2027. And -- there are no really big surprises. I would say we will continue to improve the operating margin. We are heading now past the 28% that's the target for next year, heading for 30%. We continue to take down the debt. So we will hit it going below 2 at the end of '27.
現在讓我們轉到下一張幻燈片,因為如您所知,我想設定長期目標,堅持並使其相對簡單,否則會變得過於混亂。如果你總是改變你的目標,它也會變得太混亂。去年我一直在說,我們已經接近 23 年年底。因此,與大家、分析師和投資者分享我們如何看待梯瓦的長期未來可能是一個好主意。這些是 2027 年的新長期目標。而且 - 沒有真正的大驚喜。我想說我們將繼續提高營業利潤率。我們現在正朝著明年目標的 28% 邁進,邁向 30%。我們繼續償還債務。因此,我們將在 27 年底將其降到 2 以下。
And we, of course, need strong cash to earnings. Otherwise, we can't do any of this. And we are now also focusing on revenue growth. This basically means that we will ensure that we have a compounded annual growth rate of the revenues in this period in the mid-single digits. And of course, that might mean that we'll do some small bolt-on acquisition of products or we'll do some geographic expansion of our portfolio. And we're very focused on this so that we ensure both better margin, strong cash flow, less debt and growing revenues.
當然,我們需要強勁的現金來盈利。否則,我們什麼都做不了。我們現在也專注於收入增長。這基本上意味著我們將確保我們在此期間的收入複合年增長率在中個位數。當然,這可能意味著我們將對產品進行一些小的附加收購,或者我們將對我們的產品組合進行一些地理擴張。我們非常關注這一點,以確保更高的利潤率、強勁的現金流、更少的債務和不斷增長的收入。
So just to sum it all up on my last slide, -- we think we have a very sustainable foundation, which means that we can return to growth, both on revenue and earnings and thereby pre shareholder value. The reason why we believe in the growth is what I showed you about the very strong and predictable generic business, strong growth in our biosimilars business based on our pipeline and a focused specialty pipeline combined with AUSTEDO and AJOVY, which are doing well in the market. We'll continue to drive the margin up. It's not a miracle. It's just hard work, and we'll continue with our solid cash flow generation and thereby reducing our leverage in the years to come. Thanks for listening in, and we will now move on to Q&A.
因此,在我的最後一張幻燈片上總結一下,我們認為我們有一個非常可持續的基礎,這意味著我們可以在收入和收益方面恢復增長,從而在股東價值之前。我們相信增長的原因是我向您展示了非常強大且可預測的仿製藥業務,基於我們的管道以及結合 AUSTEDO 和 AJOVY 的重點專業管道在市場上表現良好的生物仿製藥業務的強勁增長.我們將繼續提高利潤率。這不是奇蹟。這只是艱苦的工作,我們將繼續產生穩定的現金流,從而在未來幾年降低我們的槓桿率。感謝您的收聽,我們現在將繼續進行問答。
Operator
Operator
(Operator Instructions) And the first question comes from the line of Balaji Prasad from Barclays.
(操作員說明)第一個問題來自 Barclays 的 Balaji Prasad。
Balaji V. Prasad - Director
Balaji V. Prasad - Director
Kare, firstly congratulations on getting the settlement in place. So I'm curious to know what are the next steps and time lines for the settlement, specifically focusing on the caveat with Allergan? And is there a time limit by when the Allergan settlement needs to happen? And could -- if it doesn't, is there a chance that the current settlement could be rendered mode. And you could also just speak about the longer-term growth that you're guiding to. We -- now almost been conditions think of Teva's generics growth as flattish, centered around a $4 billion size. So as we look out to the longer-term generics growth of 4% plus, is it fair to assume that Teva can deliver growth equal to or greater than this longer-term generics market growth?
Kare,首先恭喜您達成和解。所以我很想知道解決的下一步和時間表是什麼,特別是關注艾爾建的警告?艾爾建(Allergan)和解的時間是否有時間限制?並且可能 - 如果沒有,是否有可能呈現當前結算模式。你也可以只談論你所指導的長期增長。我們現在幾乎認為 Teva 的仿製藥增長持平,以 40 億美元為中心。因此,當我們展望 4% 以上的長期仿製藥增長時,假設梯瓦(Teva)能夠實現等於或大於這一長期仿製藥市場增長的增長是否公平?
Kare Schultz - President, CEO & Director
Kare Schultz - President, CEO & Director
Thanks for those 2 questions. Let me start by the opioid settlement. So our expectation for the timing is that in the coming weeks, the agreement in principle will be finalized in actual wording. And as you know, the mechanics is actually that is an agreement for the states and the subdivisions to enter into an agreement because the way it works is that you agree on all the terms and how to do it and then you ask all the states and the subdivisions to sign up to this agreement. And then, of course, they get included and they get the money and the product and so on.
感謝這兩個問題。讓我從阿片類藥物解決開始。因此,我們對時機的預期是,在未來幾週內,原則上的協議將以實際措辭最終敲定。如您所知,機制實際上是州和分部簽訂協議的協議,因為它的工作方式是您同意所有條款以及如何做到這一點,然後您詢問所有州和簽署本協議的分部。然後,當然,他們被包括在內,他們得到了錢和產品等等。
And the way it typically has been working if you look at J&J and the 3 big distributors, how they did it, and we will do it very similarly -- then it works the way that there's a -- I would say, a clock start and then you have some months where people can opt in. And then after those months have passed, you have an evaluation, you have enough participation for this to be meaningful. We would definitely expect to have that given all the information we have from both the states and plaintiff lawyers and given what we sold with J&J and the 3 distributors. And then once that gets done, then state-by-state subdivision by subdivision, you sign and you start implementing. And that means that the actual implementation will start sometime next year.
如果你看看強生和 3 大分銷商,它通常的工作方式,他們是如何做到的,我們會做的非常相似——然後它的工作方式就是——我會說,一個時鐘開始然後你有幾個月的時間人們可以選擇加入。然後在這幾個月過去之後,你有一個評估,你有足夠的參與,這才有意義。鑑於我們從各州和原告律師那裡獲得的所有信息,以及我們與強生和 3 家分銷商一起銷售的產品,我們絕對希望能夠做到這一點。然後一旦完成,然後逐個州細分,您簽署並開始實施。這意味著實際實施將在明年某個時候開始。
In terms of Allergan, of course, the assumption here is that there will be an agreement where they will be also taking part in that. And I think that's by far the most likely and of course, also the best for everybody involved. In terms of the growth rate, then you're absolutely right that the sort of run rate for generic biosimilars in the U.S. is around $1 billion [a quarter] to around $4 billion. But that's, of course, not our entire business. We also have the specialty business, and we also have the generics and biosimilar business in the rest of the world. And I don't -- I do not think that the generic piece, so you would say the (inaudible) generic piece in North America and Europe will not be growing, but the biosimilar piece will be growing significantly. And that basically means that you will have a flat, maybe 1% or 2% growth on traditional generics.
當然,就 Allergan 而言,這裡的假設是他們將達成一項協議,他們也將參與其中。我認為這是迄今為止最有可能的,當然也是對所有相關人員來說最好的。就增長率而言,您絕對正確,美國仿製藥生物仿製藥的運行率約為 10 億美元 [四分之一] 至 40 億美元左右。但這當然不是我們的全部業務。我們也有專業業務,我們在世界其他地區也有仿製藥和生物仿製藥業務。而且我不 - 我不認為仿製藥,所以你會說北美和歐洲的(聽不清)仿製藥不會增長,但生物仿製藥將顯著增長。這基本上意味著傳統仿製藥的增長將持平,可能增長 1% 或 2%。
But then you'll see some complex generics, you will see biosimilars adding to the growth rate, not dramatically, but taking it up into single digit. At the same time, we had this dynamic we've discussed so many times that we've had a drag for 5 years now from COPAXONE that went from close to $5 billion now to you just saw the number $700 million. And we've had the growth of AUSTEDO and AJOVY coming in. And if you look at the guidance for this year now, we say for the first time, not only are the growth drivers bigger than the [tractor], so to speak. So the combined [singles] of AJOVY and AUSTEDO are now bigger than they could decline in sales of comparison. They've actually reached the level where they're twice as big.
但隨後你會看到一些複雜的仿製藥,你會看到生物仿製藥增加了增長率,不是顯著的,而是將其提高到個位數。與此同時,我們已經討論了很多次這種動態,以至於我們已經拖了 5 年,從現在的近 50 億美元的 COPAXONE 到現在的 7 億美元。我們已經有了 AUSTEDO 和 AJOVY 的增長。如果你現在看一下今年的指導,我們第一次說,不僅增長驅動力比 [拖拉機] 更大,可以這麼說。因此,AJOVY 和 AUSTEDO 的組合 [單曲] 現在比它們在比較銷售中可能下降的要大。它們實際上已經達到了兩倍大的水平。
So that means that the simple math, you could say, if both have a delta of 20% per year or 25%, then of course, now the specialty portfolio in that sense will contribute to growth by AJOVY and AUSTEDO growing and continuing to grow for the next 10 years. We saw, for instance, on AUSTEDO that the IP situation looks like it's very safe until the early 2030s. So that's a long growth path for AUSTEDO going forward. And so that whole combination means that we are confident that we can achieve single-digit growth. Thanks for the question.
所以這意味著簡單的數學,你可以說,如果兩者都有每年 20% 或 25% 的增量,那麼當然,現在這種意義上的專業產品組合將有助於 AJOVY 和 AUSTEDO 的增長並繼續增長未來10年。例如,我們在 AUSTEDO 上看到,直到 2030 年代初,IP 情況看起來都非常安全。因此,對於 AUSTEDO 來說,這是一條漫長的發展道路。因此,整個組合意味著我們有信心實現個位數的增長。謝謝你的問題。
Operator
Operator
We will now take the next question. And the next question comes from the line of Nathan Rich from Goldman Sachs.
我們現在來回答下一個問題。下一個問題來自高盛的 Nathan Rich。
Nathan Allen Rich - Research Analyst
Nathan Allen Rich - Research Analyst
Great. I wanted to follow up on the long-term targets. A similar question, Kare to what you had just were speaking to, but I was wondering if you could help us think about the main building blocks underlying the guidance for mid-single-digit constant currency revenue growth. And you put revenue growth as sort of the last factor on those -- that long-term target slide. So I guess, how important is achieving that to reaching the other targets on the slide? And if I could maybe ask a follow-up on your assumptions on the R&D and pipeline. It looks like you narrowed your focus on the specialty pipeline and reduced some of the programs that you had ongoing. Could you maybe just talk about the areas of focus going forward? And any new run rate for R&D spending as a percent of revenue as we think about the long-term targets?
偉大的。我想跟進長期目標。一個類似的問題,Kare 到你剛才所說的,但我想知道你是否可以幫助我們思考中個位數恆定貨幣收入增長指導的主要組成部分。你把收入增長作為最後一個因素——長期目標下滑。所以我想,實現這一目標對於實現幻燈片上的其他目標有多重要?如果我可以詢問您對研發和管道的假設的後續行動。看起來您縮小了對專業管道的關注範圍,並減少了一些正在進行的項目。您能否談談未來的重點領域?在我們考慮長期目標時,研發支出佔收入的百分比是否有任何新的運行率?
Kare Schultz - President, CEO & Director
Kare Schultz - President, CEO & Director
Thank you for those questions. If we take the long-term targets first and the safety dynamics between the different targets, then the 3 targets for margin cash earnings and debt are not linked to achieving the fourth target. So we will achieve the 3 targets even if we fail on the fourth target. But we don't plan to fail out any of the targets. We plan to reach all 4 targets. But the simple answer is we do not need revenue growth in order to reach the 3 other targets. But of course, we'd like to have revenue growth because that means that the absolute profit pool and the absolute earnings will be growing more than they will be growing if we just achieve the first 3 targets. So we are strongly committed to achieving all 4 targets.
謝謝你的這些問題。如果我們首先考慮長期目標以及不同目標之間的安全動態,那麼保證金現金收益和債務的三個目標與第四個目標的實現無關。因此,即使我們在第四個目標上失敗了,我們也將實現這三個目標。但我們不打算失敗任何目標。我們計劃實現所有 4 個目標。但簡單的答案是我們不需要收入增長來實現其他 3 個目標。但是,當然,我們希望收入增長,因為這意味著絕對利潤池和絕對收益的增長將超過我們僅實現前三個目標時的增長。因此,我們堅定地致力於實現所有 4 個目標。
And the building blocks are quite simple in a way in what I tried to illustrate that there will be growth coming from biosimilars, which will be contributing, there will be growth coming from specialty, not just from AUSTEDO and AJOVY but also (inaudible), which is the brand name for Risperidone LAI, which we still expect to launch first half of next year. So there's a portfolio of specialty products, which will be driving growth, not just in the U.S. but also in Europe, continued growth of AJOVY in Europe, AJOVY is doing very well in Europe, as you've seen, and will continue to do so for many years.
構建模塊在某種程度上非常簡單,我試圖說明生物仿製藥將帶來增長,這將做出貢獻,將來自專業的增長,不僅來自 AUSTEDO 和 AJOVY,而且(聽不清),這是利培酮 LAI 的品牌名稱,我們仍預計明年上半年推出。因此,有一系列特殊產品將推動增長,不僅在美國,而且在歐洲,AJOVY 在歐洲的持續增長,正如你所看到的,AJOVY 在歐洲做得很好,並將繼續做這麼多年。
So there's a number of growth drivers, which altogether combined with a stable position in traditional generics means that the overall revenue will be grown. Your other question is about R&D. And you're absolutely right. We are focusing in our neuroscience and immunology -- these are the areas where we have the most expertise historically and also the area where we have the best quality projects. And you're also right that we have closed a couple of projects because we didn't see that, you could say, scientific values being high enough value we could give to patients was not high enough. And therefore, we have stopped these projects. The ones we had that we showed you, they all meet very essential unmet medical needs, which basically means if they succeed, and they have a high chance of being successful.
因此,有許多增長動力,再加上傳統仿製藥的穩定地位,意味著整體收入將增長。你的另一個問題是關於研發的。你是絕對正確的。我們專注於我們的神經科學和免疫學——這些是我們歷史上最專業的領域,也是我們擁有最優質項目的領域。你也說得對,我們已經關閉了幾個項目,因為我們沒有看到,你可以說,科學價值足夠高,我們可以給患者帶來的價值還不夠高。因此,我們停止了這些項目。我們向您展示的那些,它們都滿足了非常基本的未滿足的醫療需求,這基本上意味著如果他們成功了,他們很有可能成功。
And we will continue to invest in R&D, both in generics, in biosimilars and in specialty. We do not plan to increase the percentage of revenue that we invest in R&D, but we do not plan to reduce it either, which basically means we're growing revenue, you will see that we will be spending a little bit more, but nothing dramatic. Thanks for the questions.
我們將繼續投資於仿製藥、生物仿製藥和專業領域的研發。我們不打算增加我們在研發上投資的收入百分比,但我們也不打算減少它,這基本上意味著我們正在增加收入,你會看到我們會花更多的錢,但沒有戲劇性。感謝您的提問。
Operator
Operator
We will now take the next question -- and the next question comes from the line of Umer Raffat from Evercore.
我們現在將回答下一個問題——下一個問題來自 Evercore 的 Umer Raffat。
Umer Raffat - Senior MD & Senior Analyst of Equity Research
Umer Raffat - Senior MD & Senior Analyst of Equity Research
So look, the announced settlement framework is about $3.5 billion of sort of cash value, and I'm sort of adjusting the drug for the cost of the drug. So $3.5 billion. Separately, we know that on your P&L, you had a $2.6 billion charge on an NPV basis, which was implying -- and this is as of last quarter, which was implying the equivalent of $3.5 billion to $4 billion in cumulative payments over time. So I guess I'm just a little confused why there's an additional $700 million accounting charge. That implies the value -- the NPV value higher than sort of what you do. So I just want to clarify and square that. The other one is the Allergan indemnification. I guess, why hasn't it happened already? And where do you stand on that?
所以看,宣布的和解框架大約是 35 億美元的現金價值,我正在根據藥物的成本調整藥物。所以35億美元。另外,我們知道,在您的損益表中,您根據 NPV 收取了 26 億美元的費用,這意味著——這是截至上個季度的數據,這意味著隨著時間的推移,累計支付相當於 35 億至 40 億美元。所以我想我只是有點困惑,為什麼還要額外支付 7 億美元的會計費用。這意味著價值——NPV 值高於你所做的事情。所以我只想澄清和解決這個問題。另一個是艾爾建賠償。我想,為什麼還沒有發生呢?你對此持何立場?
Kare Schultz - President, CEO & Director
Kare Schultz - President, CEO & Director
So I'll just give an overall explanation for the accrual we have, and then Eli can give you some of the details, and then I'll get back to the Allergan thing. The overall accrual includes everything. So -- and we won't comment on all the details on the agreement in principle. But you can imagine there's tons of details about the already settled cases, the product volume there, the fees in the different cases for the attorneys, tribes, different ways of the payment schedules, the 13 years, the discount rate, all kind of stuff goes into it. But the only thing I can reassure you and maybe Eli will give you some more color to it is that it's very, very comprehensive. It's very, very detailed. It's of course, done extraordinary well also together with our external accountants.
所以我只是對我們的應計做一個總體解釋,然後 Eli 可以給你一些細節,然後我會回到 Allergan 的事情上。整體應計包括一切。所以——我們原則上不會對協議的所有細節發表評論。但是你可以想像有很多關於已經解決的案件的細節,那裡的產品數量,不同案件的律師費,部落,不同的付款方式,13年,折扣率,各種各樣的東西進入它。但我唯一可以讓你放心的事情,也許 Eli 會給你更多的色彩,那就是它非常非常全面。很詳細,很詳細。當然,與我們的外部會計師一起做得非常好。
So the 3.2% is a very good picture of the net present value of all obligations, including product and everything else being involved here. But Eli, maybe you want to give some color to it.
所以 3.2% 很好地反映了所有義務的淨現值,包括產品和這裡涉及的其他一切。但是 Eli,也許你想給它一些顏色。
Eliyahu Sharon Kalif - Executive VP & CFO
Eliyahu Sharon Kalif - Executive VP & CFO
Yes. So Umer, just the high level, the $4.2 billion that we announced this one including what we call the cash element there. That's around $3.6 billion. And then we have the alternative element on the product is [240] and then some elements related to fees. And then on top of this, there is some other elements, which we cannot actually comment again related to Allergan and a few other elements that we are considering in our accrual. But one thing to understand, this is not really evenly straight line 13 years the same amount each year. We have some amounts that kind of front loaded on the 6, 7 years at the start of the assessment period. And you know we already have some prior settlement that we commit that need to actually have their own schedule already that we commit. So it's not kind of a straight line one [discomfort] you can drive and get kind of our net -- a clean NPV. And as Kare mentioned, because it's a lot of players and very sophisticated, the $3.2 billion accrual NPV base is actually considering all the elements considering that we have a full participation on the nationwide execution.
是的。所以 Umer,只是高水平,我們宣布的 42 億美元,包括我們所說的現金元素。這大約是 36 億美元。然後我們有產品上的替代元素是[240],然後是一些與費用相關的元素。然後除此之外,還有一些其他元素,我們實際上無法再次評論與艾爾建(Allergan)和我們在應計中考慮的其他一些元素。但有一點要理解,這並不是13年每年相同數量的平均直線。在評估期開始時的 6、7 年,我們有一些預先加載的金額。你知道我們已經有一些我們承諾的事先解決方案,需要實際上已經有我們承諾的他們自己的時間表。所以這不是一種直線[不適],你可以開車並獲得我們的網絡 - 一個乾淨的 NPV。正如 Kare 所提到的,因為它有很多參與者並且非常複雜,32 億美元的應計 NPV 基礎實際上正在考慮所有因素,因為我們完全參與了全國范圍的執行。
Umer Raffat - Senior MD & Senior Analyst of Equity Research
Umer Raffat - Senior MD & Senior Analyst of Equity Research
If I may just clarify then. The announced amount is $3.6 billion, which is the cash element, if I may. The NPV of what's on the P&L is $3.4 billion. So does that mean that the announced cash amount $3.6 million is actually higher than $3.6 billion is closer to $4 billion of cash based on some of these other elements "that you just mentioned?"
如果我可以澄清一下。如果可以的話,宣布的金額是 36 億美元,這是現金部分。損益表上的 NPV 為 34 億美元。那麼這是否意味著根據“你剛才提到的”其他一些因素,宣布的現金金額 360 萬美元實際上高於 36 億美元接近 40 億美元的現金?
Eliyahu Sharon Kalif - Executive VP & CFO
Eliyahu Sharon Kalif - Executive VP & CFO
They announced is $4.2 billion, up to $4.2 billion in cash, which considering the cash element, $3.6 billion plus the potential convert from product to cash along to 240, that's 20% and then additional feed element impact, right? So it's actually no one in theory getting the product, we actually took it to up to $4.2 billion. Now there are a few other elements that we consider from what we call risk assessment and explanation in our growth and that it's actually on top of it, right? And we already consider what we paid. And what I'm trying to tell you is that because it's not a straight line and the NPV is really getting different than straight line NPV because if you have upfront payments, you actually get kind of more cash on the NPV [cost], right? So that's what I tried to say.
他們宣布的是 42 億美元,最高 42 億美元的現金,考慮到現金因素,36 億美元加上從產品到現金的潛在轉換到 240,即 20%,然後是額外的飼料元素影響,對嗎?所以理論上沒有人得到這個產品,我們實際上把它帶到了 42 億美元。現在,我們從我們所謂的風險評估和解釋中考慮了一些其他因素,這些因素實際上是最重要的,對吧?我們已經考慮了我們支付的費用。我想告訴你的是,因為它不是一條直線,而且 NPV 確實與直線 NPV 不同,因為如果你有預付款,你實際上會從 NPV [成本] 上獲得更多的現金,對?這就是我想說的。
Okay. Thanks for the question. With regard to Allergan, then we don't have any further comments to that, but we expect to see them as part of the final set -- thanks for the questions.
好的。謝謝你的問題。關於艾爾建,我們對此沒有任何進一步的評論,但我們希望將它們視為最終集的一部分——感謝您的提問。
Operator
Operator
We'll now take the next question -- and the next question comes from the line of Jason Gerberry from Bank of America.
我們現在來回答下一個問題——下一個問題來自美國銀行的 Jason Gerberry。
Jason Matthew Gerberry - MD in US Equity Research
Jason Matthew Gerberry - MD in US Equity Research
So my question has to do with sort of the comprehensiveness of the deal as we know it today. When the J&J deal, I think it got announced in second half '21 and then like 120 days later, I think it was finalized. 90% of litigants had agreed, all the allocations were sorted out. So should we think about this deal as like on a similar trajectory and that most of the states and subdivisions have already sort of sorted out the allocations via the J&J deal side I almost think this could happen sooner. And then can you give any color on how many states have agreed to this -- for this working group dynamic? Just curious if you can shed any more light on that.
所以我的問題與我們今天所知的交易的全面性有關。當強生的交易時,我認為它是在 21 年下半年宣布的,然後在 120 天后,我認為它已經敲定了。 90%的當事人都同意了,所有的分配都理清了。因此,我們是否應該將這筆交易視為類似的軌跡,並且大多數州和細分市場已經通過強生交易方面對分配進行了排序,我幾乎認為這可能會更快發生。然後你能否就這個工作組動態有多少州同意這一點給出任何顏色?只是好奇您是否可以對此有所了解。
Kare Schultz - President, CEO & Director
Kare Schultz - President, CEO & Director
And so the short answer is, I think the situation is very similar. So all the details, of course, have been worked out. There's a ton of details on percentages in states and subdivisions and all that stuff, as I'm sure you know. And all those details have basically been worked out because it doesn't make sense to agree on a number if you haven't agreed on all the other details. So that's all been done. And in terms of timing, we are estimating that the timing would again be similar. So we're estimating that within the coming weeks, we'll finalize say, the wording of the settlement. But then as you rightly alluded to, you have the process where people opine states and subdivisions.
所以簡短的回答是,我認為情況非常相似。所以所有的細節,當然,已經制定好了。我相信你知道,關於州和分區的百分比以及所有這些東西有很多細節。所有這些細節基本上都已經解決了,因為如果你沒有就所有其他細節達成一致,就一個數字達成一致是沒有意義的。所以這一切都已經完成了。在時間方面,我們估計時間將再次相似。因此,我們估計在未來幾週內,我們將敲定和解的措辭。但是,正如您正確提到的那樣,您擁有人們對州和細分市場進行評論的過程。
And the understanding between the parties is, of course, that by far, the majority of states and subdivisions will opine that's the whole point of all the negotiations and not securing that you have a nationwide settlement in principle. So we are very optimistic that we will see a very high participation rate, probably similar to what you saw with J&J. And some of the states that were hold out on the J&J and the 3 distributors, we have actually already settled. As you know, we have settled West Virginia, we have settled Rhode Island, we have settled Florida. So Texas, so -- we are quite optimistic that we will, at the end of the day, see relatively few of that.
當然,雙方之間的理解是,到目前為止,大多數州和分區都會認為這是所有談判的重點,而不是確保原則上在全國范圍內解決問題。因此,我們非常樂觀地認為,我們將看到非常高的參與率,可能類似於您在強生看到的情況。而一些對強生和 3 家經銷商持保留態度的州,我們實際上已經解決了。如你所知,我們已經定居西弗吉尼亞,我們已經定居羅德島,我們已經定居佛羅里達。所以得克薩斯州,所以 - 我們非常樂觀地認為,在一天結束時,我們會看到相對較少的情況。
Operator
Operator
We will take the next question -- and it's coming from the line of Ashwani Verma from UBS.
我們將回答下一個問題——它來自瑞銀的 Ashwani Verma。
Ashwani Verma - Director of Americas Equity Research & US Specialty Pharma Analyst
Ashwani Verma - Director of Americas Equity Research & US Specialty Pharma Analyst
So on the opioid side, so just to follow up on Jason's question here, we saw in the media news that there are like [12 AG] that actively participated in the negotiation for this in-principle agreement. I'm just curious to understand the level of motivation for the remaining 35 or so AGs, like what gives you the confidence that they can join hands in the coming weeks? And why did they not participate in the negotiations in the first day. So that's the first question.
所以在阿片類藥物方面,為了跟進 Jason 的問題,我們在媒體新聞中看到,有像 [12 AG] 這樣的人積極參與了這項原則性協議的談判。我只是想了解剩下的 35 名左右 AG 的積極性水平,比如是什麼讓你有信心他們可以在未來幾週內攜手合作?以及為什麼他們第一天沒有參加談判。所以這是第一個問題。
And just second, so Kare, I just wanted to ask you now that we are presumably nearing the closing of a chapter on opioids and embarking on the next phase of the story, and we assume that you'd be part of that at Teva, we know that your current contract expires in November 2023, and we still haven't seen anything on the extension front. I remember the last 1-year extension was granted like 2 years prior to the expiration, but this time, the window is closing. So anything that you can comment on there will be really helpful.
就在第二個,所以 Kare,我現在只想問你,我們大概即將結束關於阿片類藥物的一章並開始故事的下一階段,我們假設你會成為 Teva 的一部分,我們知道您當前的合同將於 2023 年 11 月到期,我們仍然沒有看到任何關於延期的消息。我記得最後 1 年的延期是在到期前 2 年被授予的,但是這一次,窗口正在關閉。因此,您可以在那裡發表評論的任何內容都會非常有幫助。
Kare Schultz - President, CEO & Director
Kare Schultz - President, CEO & Director
Thank you. So with regard to the participation, again, I would compare to what happened with the distributors and with J&J, it's quite normal that the, you would say, negotiation group is a subset of the total number of states. So there's no indication in that number of states being directly involved. There's no indication that the other states will not end up participating. It's very, very likely, like I said before, that we will end up with a very high participation rate, just as it happened to distributors in J&J. And some of the holdout states that they saw, as I said before, we have already settled with those. So we are quite optimistic that this will be a settlement where nearly everybody will join in. With regard to my situation, it's actually correct. As you say that the contract have expires end of '23. And with regards to the future, I don't really have any comments to that right now as of today. But thanks for the question.
謝謝你。因此,關於參與,我再次將與分銷商和強生的情況進行比較,你會說,談判小組是州總數的一個子集,這是很正常的。因此,沒有跡象表明有多少州直接參與其中。沒有跡象表明其他州最終不會參與。就像我之前所說的那樣,我們很有可能最終獲得非常高的參與率,就像強生的分銷商所發生的那樣。正如我之前所說,他們看到的一些頑固狀態,我們已經解決了這些問題。所以我們非常樂觀,這將是一個幾乎每個人都會加入的解決方案。關於我的情況,它實際上是正確的。正如您所說,合同已於 23 年底到期。關於未來,截至今天,我還沒有對此發表任何評論。但謝謝你的問題。
Operator
Operator
We'll now take the next question. And the next question comes from the line of Elliot Wilbur from Raymond James.
我們現在來回答下一個問題。下一個問題來自 Raymond James 的 Elliot Wilbur。
Elliot Henry Wilbur - Senior Research Analyst
Elliot Henry Wilbur - Senior Research Analyst
I just want to shift gears here and focus on a couple of the key revenue drivers in the North American business. First, specifically AUSTEDO and thinking about trends in terms of new patient activation or new patient starts have been relatively strong, implying a fairly good return on your DTC investment earlier this year, also seeing our competitor put more money into the market, which seems to be expanding overall patient volume. Curious how you're thinking about incremental investment behind AUSTEDO over the next 12 to 18 months, either DTC or possibly even an expansion of your sales force.
我只想在這裡換個檔次,專注於北美業務的幾個主要收入驅動因素。首先,特別是 AUSTEDO 和考慮新患者激活或新患者開始方面的趨勢相對強勁,這意味著您今年早些時候的 DTC 投資回報率相當不錯,而且我們的競爭對手也向市場投入了更多資金,這似乎擴大整體患者數量。好奇您如何考慮在未來 12 到 18 個月內對 AUSTEDO 背後的增量投資,無論是直接投資還是可能擴大您的銷售隊伍。
And then as a follow-up, I want to focus specifically on North American generics, maybe just get your latest read in terms of key trends such as price erosion, volume trends, what we're seeing in terms of new product approval flow still seems to be relatively difficult to get complex generics out of the FDA, but wondering if you're getting any indications that we may be approaching an inflection point in terms of starting to see approval flow pick up. But just a general outlook on North American generics for the second half of the year.
然後作為後續行動,我想特別關注北美仿製藥,也許只是從價格侵蝕、數量趨勢等關鍵趨勢方面了解您的最新信息,以及我們在新產品批准流程方面所看到的情況從 FDA 獲得複雜的仿製藥似乎相對困難,但想知道您是否有任何跡象表明我們可能正在接近一個拐點,開始看到批准流量回升。但只是對下半年北美仿製藥的總體展望。
Kare Schultz - President, CEO & Director
Kare Schultz - President, CEO & Director
Yes. Thank you for those 2 questions. I'll give a very brief answer, and then I'll hand it over to Sven to give the detailed answers. We're very happy about the progress on scripts with AUSTEDO and patient. So that looks good. And we're also happy about the performance of generics in North America here in the second quarter, heating in North America, combined with the biosimilars around $1 billion. So that looks good. But for more details, over to Sven.
是的。謝謝你的這2個問題。我會給出一個非常簡短的答案,然後交給斯文給出詳細的答案。我們對 AUSTEDO 和耐心的腳本進展感到非常高興。所以看起來不錯。我們也對第二季度北美仿製藥的表現感到高興,北美供暖,再加上約 10 億美元的生物仿製藥。所以看起來不錯。但有關更多詳細信息,請轉到 Sven。
Sven Dethlefs - EVP of North America Commercial
Sven Dethlefs - EVP of North America Commercial
Yes. Thank you, [Aviad]. So for AUSTEDO, we had strong TRx growth of 27% in the first half of this year versus last year. And also the new patients have developing strongly. The analytics grew 32% in the same period. So we are definitely achieving our goal in terms of patient activation, and that was one of the key objectives for this year.
是的。謝謝你,[Aviad]。因此,對於 AUSTEDO,與去年相比,今年上半年我們的 TRx 增長了 27%。而且新患者的發展勢頭也很強勁。分析在同一時期增長了 32%。因此,我們肯定在患者激活方面實現了我們的目標,這是今年的主要目標之一。
For that reason, we are also confident that we achieve our sales target that we set for ourselves in the second half of the year. As to your question about our marketing investments, we have achieved our goals of patient activation in the first half of this year. And we've also seen that we significantly increased the prescriber base, which speaks to the fact that the TV campaign was actually effective. We're now focusing our investments on downstream activities on sales, on the titration management on patient adherence, and we believe we have a significant potential in that area. And we already did these investments in terms of sales force expansion and other activities. So we are fully on top of the stable development.
出於這個原因,我們也有信心實現我們在下半年為自己設定的銷售目標。關於您對我們營銷投資的問題,我們在今年上半年實現了患者激活的目標。我們還看到,我們顯著增加了開處方者的基礎,這說明電視宣傳活動確實有效。我們現在將投資重點放在銷售的下游活動、患者依從性的滴定管理上,我們相信我們在該領域具有巨大的潛力。我們已經在銷售隊伍擴張和其他活動方面進行了這些投資。所以我們完全處於穩定發展之上。
On generics, our expectation is that the level of generic price erosion is trending back towards historic rates. We expect to see an incremental stabilization especially for the segment of base generics in the second half of this year. It does not mean that we don't have price erosion. We just have stable price erosion, and we do not expect an additional acceleration for our portfolio. So concerning our own development, of course, the most significant factor for business stability is the rate of new product launches and a gradual shift to high-barrier generics, which have a more sustainable pricing profile. And these are products like EpiPen, the patches we have, the inhaler we launched and long-term -- other long-term injectables, they are more durable than the base generics business.
在仿製藥方面,我們的預期是仿製藥價格侵蝕的水平正在回歸歷史水平。我們預計今年下半年基礎仿製藥部分將逐漸穩定。這並不意味著我們沒有價格侵蝕。我們只是有穩定的價格侵蝕,我們預計我們的投資組合不會進一步加速。因此,就我們自身的發展而言,業務穩定的最重要因素當然是新產品的推出速度以及逐漸轉向具有更可持續定價特徵的高壁壘仿製藥。這些是像 EpiPen 這樣的產品,我們擁有的貼片,我們推出的吸入器和長期 - 其他長期注射劑,它們比基礎仿製藥業務更耐用。
And what we see here is that, of course, you are right, the FDA is currently seen significant barriers for complex generic approvals for that reason, some of our approvals that we expected for this year are now happening next year. But overall, we believe that especially in 2023, we see 2 elements that we get to a higher rate of product approvals, and we will also have with the Humira biosimilar launch, I think, for our generics business, an inflection point for the future because we have other biosimilars lined up after that, so that we are optimistic about the outlook of our North American generics business. Thank you.
我們在這裡看到的是,當然,你是對的,由於這個原因,FDA 目前認為複雜的仿製藥批准存在重大障礙,我們預計今年的一些批准現在正在明年發生。但總體而言,我們認為,尤其是在 2023 年,我們看到兩個因素使我們獲得更高的產品批准率,而且隨著 Humira 生物類似藥的推出,我認為,對於我們的仿製藥業務來說,這是未來的轉折點因為在那之後我們還有其他生物仿製藥,所以我們看好我們北美仿製藥業務的前景。謝謝你。
Operator
Operator
We will now take the next question. And the next question comes from the line of Gary Nachman from BMO Capital Markets.
我們現在來回答下一個問題。下一個問題來自 BMO Capital Markets 的 Gary Nachman。
Gary Jay Nachman - Analyst
Gary Jay Nachman - Analyst
So back to the proposed settlement, how much are the payments front end loaded over the first 6 years that you highlighted in answering Umer's question. And how much is spread out over the next 7 years? I just want to have a better idea on how to model that, even if you could give us order of magnitude, if you don't want to give us the specifics there. And then on the long-term revenue objective, at what stage will you be able to do business development again? You mentioned as part of revenue growth, that will be one element. Where does leverage need to be in order to start doing that? And then just give us any catalyst anytime soon from the specialty pipeline that you -- you can highlight -- I know you'll have an R&D Day, but just give us some of the key catalysts, if you can.
回到提議的解決方案,您在回答 Umer 的問題時強調的前 6 年支付前端加載了多少。未來 7 年會分配多少?我只是想對如何建模有一個更好的想法,即使你可以給我們一個數量級,如果你不想給我們那裡的細節。然後在長期收入目標上,您將能夠在什麼階段再次進行業務發展?您提到作為收入增長的一部分,這將是一個要素。為了開始這樣做,槓桿需要在哪裡?然後,請盡快從專業管道中給我們任何催化劑——你可以強調——我知道你會有一個研發日,但如果可以的話,請給我們一些關鍵的催化劑。
Kare Schultz - President, CEO & Director
Kare Schultz - President, CEO & Director
Thank you very much. So if we take the settlement first, then what Eli was alluding to was that there are some current settlements that we have already done with individual states where we're actually paying cash already this year. We have actually already paid cash in the first and the second quarter. If you look from next year and going forward, then the variations per year are actually marginal. So you should imagine you take the total amount and divide it by 13. And then the swing factors up and down are marginal. -- is not dramatic. So it's somewhere between, say, $300 million and $400 million per year in net cash for all the different elements. So it's not front end loaded in that extent. It's just the fact that we have some settlements we already did, where we have already paid some money this year, a couple of hundred million so far. So that's really it on the settlement.
非常感謝。因此,如果我們首先進行和解,那麼 Eli 所暗示的是,我們已經與個別州完成了一些當前的和解,我們今年實際上已經支付了現金。我們實際上已經在第一季度和第二季度支付了現金。如果您從明年開始展望未來,那麼每年的變化實際上是微不足道的。所以你應該想像你把總量除以 13。然後上下波動的因素是微不足道的。 ——沒有戲劇性。因此,所有不同元素的淨現金每年介於 3 億美元到 4 億美元之間。所以它不是在那個程度上加載前端。只是我們已經完成了一些和解,今年我們已經支付了一些錢,到目前為止已經支付了幾億。所以這就是解決方案。
Then on say, the business development side, we already do small business development deals where we do bolt-ons of individual products. For instance, it's a business development deal that's behind the Humira launch that we are planning with biosimilar Humira launch we are planning for next year, a deal we did with Alvotech, the biosimilar, we just launched in U.K. Biosimilar to Lucentis in the U.K., that's also a business development deal. So we do business development deals, and we will continue to do so.
然後說,在業務開發方面,我們已經進行了小型業務開發交易,我們對單個產品進行了補充。例如,我們計劃在明年推出 Humira 生物仿製藥 Humira 背後的業務發展交易,我們與 Alvotech 達成的交易,我們剛剛在英國推出的生物仿製藥與 Lucentis 在英國的生物仿製藥,這也是一項業務發展協議。因此,我們進行業務開發交易,我們將繼續這樣做。
If you think about when is there more room significantly more room in the balance sheet to do something slightly bigger than this -- that will be at the end of the 5-year period because since we're aiming for a net debt-to-EBITDA below 2, then if you do sort of the math on a marginally growing EBITDA, and therefore, the net EBITDA will be growing over that period, a constant decline in net debt. Then of course, you hit that around 2x net debt to EBITDA. You hit that before the end of '27. And that means when you get close to that or when you get below that, then of course, you have some room within these targets to do a little bit more (inaudible). But you're still at this size where it's, I would call it, smaller bolt-on things you can do.
如果您考慮一下資產負債表中何時有更多空間來做比這更大的事情——那將是在 5 年期結束時,因為我們的目標是淨債務與—— EBITDA 低於 2,那麼如果您對略微增長的 EBITDA 進行某種數學計算,因此,淨 EBITDA 將在此期間增長,淨債務持續下降。然後,當然,你達到了大約 2 倍的 EBITDA 淨債務。你在 27 年年底之前達到了這個目標。這意味著,當您接近該目標或低於該目標時,當然,您在這些目標中有一些空間可以做更多的事情(聽不清)。但是你仍然處於這個尺寸,我會稱之為,你可以做的更小的螺栓固定的東西。
And there's a lot of opportunities there. There's a lot of companies who develop products and then they don't really have a commercial setup. So they need a partner. And we have a good tradition of partnering with many different companies. So we think we can continue to do so. And that will be one small element in continuing the growth of our revenues. With regard to the pipeline, I think there's a lot of exciting things there. And I won't go into the details now, but just say that, of course, next year, the long-acting Risperidone looks extremely good from a clinical point of view, both efficacy and safety, and it will be a major improvement of low-end acting antipsychotics that you can do subcutaneously, and it works for 1 or 2 months. So that's going to be really nice to get that finally approved and launch next year. Thanks for the questions.
那裡有很多機會。有很多公司開發產品,然後他們並沒有真正的商業設置。所以他們需要一個合作夥伴。我們擁有與許多不同公司合作的良好傳統。所以我們認為我們可以繼續這樣做。這將是我們收入持續增長的一小部分。關於管道,我認為那裡有很多令人興奮的事情。而且我現在不詳述,只是說,當然,明年長效利培酮從臨床上看,無論是療效還是安全性,看起來都非常好,而且會是一個重大的進步。可以皮下注射的低端抗精神病藥,效果一到兩個月。因此,最終獲得批准並在明年推出將是非常好的。感謝您的提問。
Operator
Operator
We will now take the next question. Please stand by. And the next question comes from the line of David Amsellem from Piper Sandler.
我們現在來回答下一個問題。請待命。下一個問題來自 Piper Sandler 的 David Amsellem。
David A. Amsellem - MD & Senior Research Analyst
David A. Amsellem - MD & Senior Research Analyst
So a couple of questions. So one, just thinking at a high level about the business. One of your U.S. major peers, Viatris has talked openly about divestitures. And I just wanted to pick your brain Kare on how you're thinking about divestitures, particularly as a means to generate proceeds and perhaps then be able to more aggressively pivot towards the acquisition of brand assets. Brand assets being a question and a topic that come up comes up quite frequently. So how are you thinking about that, particularly now that you've gotten the opioid settlement largely behind you?
所以有幾個問題。所以一個,只是從高層次上考慮業務。作為您的美國主要同行之一,Viatris 公開談論了資產剝離。我只是想了解一下你對資產剝離的看法,尤其是作為一種產生收益的手段,然後也許能夠更積極地轉向收購品牌資產。品牌資產是一個經常出現的問題和話題。那麼您如何看待這一點,特別是現在您已經在很大程度上擺脫了阿片類藥物的解決?
And then secondly, just switching gears to the Humira biosimilar. Just latest thoughts on how you're thinking about that, not just in terms of time line, but also how are you thinking about the ramp and adoption here? Just your general thoughts there.
其次,只是切換到 Humira 生物仿製藥。只是關於你如何考慮的最新想法,不僅僅是在時間線方面,還有你如何考慮這裡的斜坡和採用?只是你的一般想法。
Kare Schultz - President, CEO & Director
Kare Schultz - President, CEO & Director
Thanks for the questions. I'll take the first one and then Sven can take the second one. So with regards to divestments, what we've done in the last 5 years is we've really analyzed the entire value chain, the entire business. And we have sold off those elements that we thought had no strategic synergy with the rest of the business. And we've kept all the elements that indeed gives us a strong synergistic effect. So we have no plans of divesting any parts of our business. We basically have the plan to integrate and optimize the business we have elected to keep because we believe it all fits very well together. So we will be working, like I explained earlier on in the strategy to further optimize, further increase the gross margin, the operating margin and building a stronger and stronger foundation.
感謝您的提問。我會拿第一個,然後 Sven 可以拿第二個。因此,關於撤資,我們在過去 5 年中所做的是我們真正分析了整個價值鏈,整個業務。我們已經出售了那些我們認為與其他業務沒有戰略協同作用的元素。我們保留了所有確實給我們帶來強大協同效應的元素。因此,我們沒有剝離任何業務的計劃。我們基本上有計劃整合和優化我們選擇保留的業務,因為我們相信這一切都非常適合。因此,我們將像我之前解釋的那樣,在戰略中進一步優化,進一步提高毛利率、營業利潤率,並建立越來越強大的基礎。
And then we will, as a consequence of the debt reduction and the margin improvement, free up more and more cash to do what you said, acquisitions of branded products either in one or another area. But it will happen organically, you could say that we generate more and more flexibility to do so with the debt reduction and the margin improvement. And then on Humira, Sven.
然後,由於債務減少和利潤率提高,我們將騰出越來越多的現金來做你所說的,在一個或另一個領域收購品牌產品。但這將有機地發生,你可以說我們通過減少債務和提高利潤率來產生越來越多的靈活性。然後是修美樂,斯文。
Sven Dethlefs - EVP of North America Commercial
Sven Dethlefs - EVP of North America Commercial
Yes. Thank you. I think the question was about the expectation for uptake of Humira next year. Just as a reminder, engine comes in January with their biosimilar and then a whole range of other companies, including us in July 2023. I believe the uptick will be largely defined by the contracting strategies of [PBMs] and our customers how they think they would like to build the biosimilar market versus the offer that they get from [AbbVie]. And that will be a 2-step approach, one that will happen in 2023, primarily in the summer of 2023. And then you will see a second phase in 2024 when the whole book of contracting will be opened again. I believe we are in a good position. We have the best product profile of all companies coming to the market in 2023, and we are already in discussions with all our customers about the access approach for next year. And we -- I think we know more about that at the end of this year when all the contracting has been done.
是的。謝謝你。我認為問題是關於明年使用 Humira 的期望。提醒一下,engine 將在 1 月份推出他們的生物仿製藥,然後是一系列其他公司,包括我們在 2023 年 7 月。我相信上升將在很大程度上取決於 [PBMs] 的合同策略以及我們的客戶如何看待他們想要建立生物仿製藥市場,而不是他們從 [AbbVie] 獲得的報價。這將是一個兩步走的方法,一個將在 2023 年發生,主要是在 2023 年夏天。然後你會在 2024 年看到第二階段,屆時整個合同書將再次打開。我相信我們處於一個很好的位置。在 2023 年進入市場的所有公司中,我們擁有最好的產品概況,我們已經在與所有客戶討論明年的准入方法。而且我們 - 我認為我們會在今年年底完成所有合同時對此了解更多。
Kare Schultz - President, CEO & Director
Kare Schultz - President, CEO & Director
So thank you very much for all your questions, and thank you for listening in, and have a nice day. Bye-bye.
非常感謝您提出的所有問題,感謝您的聆聽,祝您有美好的一天。再見。
Operator
Operator
That does conclude our conference for today. Thank you for participating. You may all disconnect. Speakers, please stand by.
這確實結束了我們今天的會議。感謝您的參與。你們都可以斷開連接。演講者,請稍候。