Teva Pharmaceutical Industries Ltd (TEVA) 2017 Q4 法說會逐字稿

完整原文

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

  • Operator

    Operator

  • Good afternoon, ladies and gentlemen, and thank you for standing by, and welcome to the fourth quarter 2017 financial results.

    下午好,女士們,先生們,感謝你們的支持,歡迎來到 2017 年第四季度財務業績。

  • (Operator Instructions) I must advice you this conference is being recorded today, Thursday, the 8th of February 2018.

    (操作員說明)我必須告訴您,今天,星期四,2018 年 2 月 8 日,正在錄製本次會議。

  • I'd now like to hand the conference over to your speaker today, Kevin Mannix, Senior Vice President, Head of Investor Relations.

    我現在想把會議交給你今天的演講者,高級副總裁兼投資者關係主管 Kevin Mannix。

  • Please go ahead.

    請繼續。

  • Kevin C. Mannix - Head of Global IR & VP

    Kevin C. Mannix - Head of Global IR & VP

  • Thank you, Tracy, and thank you, everyone for joining us today to discuss Teva's fourth quarter and full year 2017 financial results.

    謝謝你,特蕾西,也謝謝大家今天加入我們討論梯瓦公司第四季度和 2017 年全年的財務業績。

  • Earlier this morning, we issued our press release detailing our results for the quarter and year.

    今天早上早些時候,我們發布了我們的新聞稿,詳細說明了我們的季度和年度業績。

  • 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 www.tevapharm.com as well as on our Teva Investor Relations app.

    可以在我們的網站 www.tevapharm.com 以及我們的梯瓦投資者關係應用程序上找到新聞稿的副本以及本次電話會議中展示的幻燈片的副本。

  • Our discussion today includes certain non-GAAP measures as defined by the SEC.

    我們今天的討論包括美國證券交易委員會定義的某些非公認會計原則措施。

  • Management uses both GAAP financial measures and the disclosed non-GAAP financial measures internally to evaluate and manage the company's operations to better understand its business.

    管理層在內部使用 GAAP 財務指標和披露的非 GAAP 財務指標來評估和管理公司的運營,以更好地了解其業務。

  • Further, management believes the inclusion of non-GAAP financial measures provides meaningful supplementary information to and facilitates analysis by investors in evaluating the company's financial performance, results of operations and trends.

    此外,管理層認為,納入非公認會計原則財務措施為投資者提供了有意義的補充信息,並有助於投資者在評估公司的財務業績、經營業績和趨勢時進行分析。

  • Reconciliation of GAAP to non-GAAP measures are available in our earnings release and in today's presentation.

    GAAP 與非 GAAP 措施的對賬可在我們的收益發布和今天的演示文稿中找到。

  • Today, Kåre Schultz, our Chief Executive Officer, will open the call with some remarks on our annual results, recent events and outlook for 2018.

    今天,我們的首席執行官 Kåre Schultz 將在電話會議開始時就我們的年度業績、近期事件和 2018 年展望發表一些評論。

  • Mike McClellan, our Chief Financial Officer will review the fourth quarter financial results in more detail and discuss additional assumptions around our 2018 outlook.

    我們的首席財務官 Mike McClellan 將更詳細地審查第四季度的財務業績,並討論圍繞我們 2018 年展望的其他假設。

  • And I'd also like to note that on the call with us and available during the Q&A is Brendan O'Grady, Teva's Head of North America Commercial.

    我還想指出,在與我們通話並在問答期間可用的是梯瓦 (Teva) 北美商業主管 Brendan O'Grady。

  • And with that, I'll now turn the call over to Kåre.

    有了這個,我現在將把電話轉給 Kåre。

  • Kåre, if you would please.

    Kåre,如果你願意的話。

  • Kåre Schultz - Former CEO & President

    Kåre Schultz - Former CEO & President

  • Good morning, everybody, and thanks for calling in.

    大家早上好,感謝您的來電。

  • Before we start, please read our cautionary note regarding forward-looking statements.

    在我們開始之前,請閱讀我們關於前瞻性陳述的警告說明。

  • As Kevin said, I'll address the full year.

    正如凱文所說,我將談到全年。

  • And if we start looking on the revenues, then revenues came in marginally above 2016, and there was, of course, a combination of the full inclusion of the generic sales in the U.S. and then some downward pressure on COPAXONE in these numbers.

    如果我們開始看收入,那麼收入略高於 2016 年,當然,美國的仿製藥銷售完全包括在內,然後這些數字對 COPAXONE 有一些下行壓力。

  • The operating income came in slightly below and as well the net income.

    營業收入略低於淨收入。

  • If you look at the earnings, we came out with a non-GAAP result of $4 for the full year, which is in line with the predictions we had in the outlook after the third quarter.

    如果您查看收益,我們得出的全年非 GAAP 業績為 4 美元,這與我們對第三季度後前景的預測一致。

  • If you look at the GAAP results, then you'll see similar revenue, of course, and then you'll see a significant loss on the operating income, and this is related to a significant impairment of the goodwill in the U.S. generics businesses primarily, but Mike will get back to some of the details later.

    如果您查看 GAAP 結果,那麼您當然會看到類似的收入,然後您會看到營業收入出現重大損失,這主要與美國仿製藥業務商譽的重大減值有關,但邁克稍後會回到一些細節。

  • If we look at the cash flow, which is of course important in a situation where we are deleveraging and reducing our debt on an ongoing basis, you can see that the net cash flow, including divestitures and also the free cash flow came in nicely, so that we were able to continue the reduction of our debt in 2017.

    如果我們看一下現金流,這在我們持續去槓桿和減少債務的情況下當然很重要,你可以看到淨現金流,包括資產剝離和自由現金流都很好,以便我們能夠在 2017 年繼續減少債務。

  • One of the key elements of our business outlook is our restructuring plan, which we revealed to all of you mid-December.

    我們的業務前景的關鍵要素之一是我們的重組計劃,我們在 12 月中旬向大家披露了該計劃。

  • The short message on the restructuring plan is that everything is on plan, everything is on target, but let me give you a bit of flavor to it.

    重組計劃的簡短信息是,一切都在計劃中,一切都在目標中,但讓我給你一點味道。

  • We have our new organizational structure in place, all levels down in terms of managing teams, and it's this new organization that has created our annual operating plan for 2018, which forms the basis for the guidance that we're giving you all today.

    我們已經建立了新的組織結構,在管理團隊方面的所有級別都下降了,正是這個新組織製定了我們 2018 年的年度運營計劃,這構成了我們今天為大家提供的指導的基礎。

  • We have planned, as we communicated in December, a reduction of our global workforce from 53,000 to 39,000.

    正如我們在 12 月所傳達的那樣,我們計劃將全球員工人數從 53,000 人減少到 39,000 人。

  • So a 14,000 persons' reduction.

    因此減少了 14,000 人。

  • Half of this reduction is expected to be completed by the end of Q2 of this year, and the remaining half would be over the following 6 quarters throughout '18 and '19.

    預計減產的一半將在今年第二季度末完成,剩下的一半將在 18 年和 19 年的接下來的 6 個季度中完成。

  • Everything is moving according to plan, and despite the fact that we have seen some onerous in Israel, which is now completely calm, we don't see anything that will block us from executing exactly as planned.

    一切都在按計劃進行,儘管我們在以色列看到了一些繁重的事情,現在完全平靜了,但我們沒有看到任何阻礙我們完全按計劃執行的事情。

  • This includes a lot of closures and divestments as we've alluded to before.

    這包括我們之前提到的許多關閉和撤資。

  • In this period here, we have had 6 announced closures of plants since we announced the restructuring plan, and we're expecting to announce another 6 plants by year-end of this year.

    在此期間,自我們宣布重組計劃以來,我們已經宣布關閉 6 家工廠,我們預計到今年年底將宣布另外 6 家工廠。

  • But this is, of course, an ongoing process to consolidate our manufacturing footprint across this, which will go on all the way to '19, but also during the following years.

    但這當然是一個持續的過程,以鞏固我們在這方面的製造足跡,這將一直持續到 19 年,而且在接下來的幾年中也是如此。

  • We've also communicated that we are working on an optimization of our generics portfolio on a worldwide basis and in the U.S. I'm happy to inform you that we're, of course, doing this in a very constructive way talking with our key customers, discussing the issues and making sure that we find a solution regarding unprofitable products either in the form of price adjustments or discontinuation of the products from our side.

    我們還表示,我們正在全球和美國優化我們的仿製藥產品組合。我很高興地通知您,我們當然正在以非常建設性的方式與我們的關鍵客戶,討論問題並確保我們找到有關無利可圖產品的解決方案,無論是價格調整還是我們方面的產品停產。

  • We also have taken a very close look at all our R&D programs.

    我們還非常仔細地研究了我們所有的研發計劃。

  • And in the specialty area, we have cut roughly 27% of our programs.

    在專業領域,我們削減了大約 27% 的項目。

  • Basically these are programs that fall outside our core expertise area and where it's very speculative whether we would be able to return a profitable investment out of these programs.

    基本上,這些項目不屬於我們的核心專業領域,我們是否能夠從這些項目中獲得有利可圖的投資是非常投機的。

  • And we have also trimmed our generics portfolio.

    我們還削減了我們的仿製藥產品組合。

  • We have the world's largest portfolio of generic filings, and we've done a reduction there of a minor scale, but still it's 100 programs.

    我們擁有世界上最大的仿製藥申請組合,並且我們已經進行了小規模的縮減,但仍然是 100 個項目。

  • The short message is, we are on track to achieve the $3 billion spend base reduction that we communicated earlier, and that more than half of this will happen in '18, and the full amount will be realized in 2019.

    簡短的信息是,我們有望實現我們之前傳達的 30 億美元的支出基數削減,其中一半以上將在 18 年發生,全部金額將在 2019 年實現。

  • In terms of growth drivers, one of the key growth drivers is, of course, our specialty assets.

    就增長動力而言,關鍵的增長動力之一當然是我們的專業資產。

  • And as you know, we have launched AUSTEDO last year.

    如您所知,我們去年推出了 AUSTEDO。

  • AUSTEDO is launched for both tardive dyskinesia and chorea in Huntington's disease, and it was launched first for Huntington's and later on for tardive dyskinesia.

    AUSTEDO 是針對亨廷頓病的遲發性運動障礙和舞蹈症推出的,它首先是針對亨廷頓病推出的,後來又針對遲發性運動障礙推出。

  • It's doing very well.

    它做得很好。

  • We are accumulating patients exactly as we were planning.

    我們正在按照我們的計劃收集病人。

  • So we're very optimistic about the future growth of this very important product.

    所以我們對這個非常重要的產品的未來增長非常樂觀。

  • We're also doing further clinical trials in Tourette basically in order to broaden the clinical basis for this product and thereby also increase the growth potential in the marketplace.

    我們還在圖雷特進行進一步的臨床試驗,基本上是為了拓寬該產品的臨床基礎,從而增加市場的增長潛力。

  • This year, we are all very much focused on fremanezumab.

    今年,我們都非常關注fremanezumab。

  • We have a PDUFA date in June '16.

    我們在 16 年 6 月有一個 PDUFA 日期。

  • As you know, we bought a voucher so we had an expectation that we will see a very fast handling of the review process from FDA, and we are actually seeing that.

    如您所知,我們購買了一張代金券,因此我們期望我們會看到 FDA 快速處理審查過程,我們實際上正在看到這一點。

  • We are, of course, in constant dialogue with the FDA and they are moving ahead very nicely with inspecting the different elements such as the clinical elements and the finished manufacturing, and that is all looking very, very well.

    當然,我們一直在與 FDA 進行對話,他們在檢查臨床要素和成品製造等不同要素方面進展順利,這一切看起來都非常非常好。

  • We have 1 new issue that we are flagging here.

    我們在此處標記了 1 個新問題。

  • And that is the fact that our API is manufactured by our partner Celltrion in Korea.

    這就是我們的 API 是由我們在韓國的合作夥伴 Celltrion 製造的事實。

  • They have received a warning letter, and we are in active dialogue with FDA in order to ensure that this warning letter would not affect the supplies of API from Celltrion to our fremanezumab program.

    他們收到了一封警告信,我們正在與 FDA 積極對話,以確保這封警告信不會影響 Celltrion 向我們的 fremanezumab 項目供應 API。

  • We are optimistic that we would be able to prove that the API manufacturing is in good shape, but it, of course, remains to be settled in a discussion with FDA.

    我們對能夠證明 API 製造狀況良好感到樂觀,但當然,這仍有待與 FDA 討論來解決。

  • We are also here working to broaden the clinical basis for the products that we -- are in Phase III with cluster headaches, and we are starting an early Phase II program on post-traumatic headache, all very exciting and huge potentials.

    我們還在這裡努力拓寬我們的產品的臨床基礎——我們正處於叢集性頭痛的 III 期,並且我們正在啟動創傷後頭痛的早期 II 期計劃,所有這些都非常令人興奮和巨大的潛力。

  • In the area of Pain, we have a collaboration with Regeneron on fasinumab.

    在疼痛領域,我們與 Regeneron 合作開發 fasinumab。

  • This is a very exciting product, which will be able to handle pain in osteoarthritis and chronic lower back pain.

    這是一個非常令人興奮的產品,它將能夠治療骨關節炎和慢性腰痛的疼痛。

  • We're in Phase III, and we are looking forward to seeing the results in the coming years on this very exciting product.

    我們正處於第三階段,我們期待在未來幾年看到這個非常令人興奮的產品的結果。

  • I've mentioned before that it's very important for us to secure the cash flow, and the reason for that is, of course, as you all know that we have significant debt.

    我之前提到過,確保現金流對我們來說非常重要,其原因當然是因為你們都知道我們有大量債務。

  • And as I've told many of you, I don't really like a company like ours to have this much debt as we have, and therefore, we simply have to reduce it and we are working hard on that.

    正如我告訴你們許多人的那樣,我真的不喜歡像我們這樣的公司有這麼多債務,因此,我們只需要減少它,我們正在努力解決這個問題。

  • And here you see the sort of debt facing us in the coming years, and here's a small footnote that's just to communicate that we are reducing the debt on an ongoing basis.

    在這裡,您可以看到我們在未來幾年面臨的那種債務,這裡有一個小腳註,只是為了傳達我們正在持續減少債務。

  • And since the end of last year, which are the bars you're seeing here, we've actually reduced the debt by $1.1 billion in little more than a month that is past incident.

    自去年年底以來,你在這裡看到的酒吧,我們實際上已經在過去的一個多月內將債務減少了 11 億美元。

  • Unfortunately, we won't keep that speed exactly.

    不幸的是,我們不會完全保持這個速度。

  • $1 billion a month going forward would have been nice, but it will be slightly less as you can see from the expected cash flows we have.

    未來每月 10 億美元本來不錯,但從我們的預期現金流可以看出,它會稍微少一些。

  • But we are optimistic that we will keep on reducing it, and we have several liquidity items that are positive.

    但我們樂觀地認為我們將繼續減少它,並且我們有幾個積極的流動性項目。

  • We are getting $700 million from the Allergan settlement, and we have strong organic cash flow.

    我們從艾爾建和解中獲得了 7 億美元,我們擁有強大的有機現金流。

  • And we have also renegotiated our covenants in order to make sure that we have the needed financial flexibility to keep on reducing the debt in a very stable situation.

    我們還重新談判了我們的契約,以確保我們擁有所需的財務靈活性,以在非常穩定的情況下繼續減少債務。

  • With regards to the outlook for the full year 2018, you will see here that we're expecting a significant reduction of revenues.

    關於 2018 年全年的展望,您將在這裡看到我們預計收入將大幅減少。

  • There are really 4 main reasons for it.

    確實有4個主要原因。

  • We would say a fourth of it is structural.

    我們會說其中四分之一是結構性的。

  • These items like the Women's Healthcare that we've sold off, some distribution businesses we've sold off, the Venezuela business that we have deconsolidated and so on.

    這些項目比如我們賣掉的女性醫療保健,我們賣掉的一些分銷業務,我們已經分拆的委內瑞拉業務等等。

  • That's roughly a fourth of the decline.

    這大約是下降的四分之一。

  • And then you have another fourth, which is roughly the generics, the price ratio we've seen in the U.S. and also some of the changes we've seen in Japan.

    然後還有第四個,大致是仿製藥,我們在美國看到的價格比率,以及我們在日本看到的一些變化。

  • And then there's roughly half the decline, which is related to the generic competition on COPAXONE.

    然後大約有一半的下降,這與 COPAXONE 的仿製藥競爭有關。

  • This, of course, also leads to a drop in operating income.

    當然,這也導致營業收入下降。

  • It's less than the drop in revenues.

    這低於收入的下降。

  • One of the reasons being that we are expecting to see half of the effect of our restructuring program come in as a $1.5 billion reduction of the spend base.

    原因之一是我們預計重組計劃的一半效果來自於支出基數減少 15 億美元。

  • Of course, that will be more in '19 where it goes up to $3 billion.

    當然,在 19 年會更多,達到 30 億美元。

  • EBITDA is between $4.7 billion and $5 billion what we're expecting, and the EPS between $2.25 and $2.50.

    EBITDA 介於我們預期的 47 億美元和 50 億美元之間,每股收益介於 2.25 美元和 2.50 美元之間。

  • Free cash flow, which is, in this case, without potential divestitures that we might see later in the year, is coming out at $2.6 billion to $2.8 billion.

    自由現金流,在這種情況下,沒有我們可能在今年晚些時候看到的潛在資產剝離,將達到 26 億至 28 億美元。

  • With this review of the full year, I'll now hand over to Mike McClellan, who will look at the fourth quarter.

    通過對全年的回顧,我現在將交給邁克麥克萊倫,他將關注第四季度。

  • Michael McClellan - Executive VP & CFO

    Michael McClellan - Executive VP & CFO

  • Okay.

    好的。

  • Thank you, Kåre.

    謝謝你,卡雷。

  • Good morning, everyone.

    大家,早安。

  • You've received a lot of information today in our press release, and I'd like to take the time I have to highlight what we think are some important areas of our results to focus on as well as to share with you some key assumptions that we have made for our outlook of 2018.

    您今天在我們的新聞稿中收到了很多信息,我想花點時間強調一下我們認為需要關注的一些重要結果領域,並與您分享一些關鍵假設這是我們為 2018 年的展望所做的。

  • So turning to Slide 11.

    所以轉向幻燈片 11。

  • We start with a review of our GAAP performance, where we posted a quarterly GAAP operating loss of $13 billion in the fourth quarter of 2017.

    我們首先回顧一下我們的 GAAP 業績,我們在 2017 年第四季度公佈了 130 億美元的季度 GAAP 運營虧損。

  • This is driven primarily from $14.3 billion of impairments, mainly related to the U.S. generic business in goodwill and other intangibles and partially offset by a gain on our Women's Health divested business and a onetime tax benefit that I'll go into later.

    這主要來自 143 億美元的減值損失,主要與商譽和其他無形資產的美國仿製藥業務有關,部分被我們剝離的女性健康業務的收益和我稍後將介紹的一次性稅收優惠所抵消。

  • During the fourth quarter of 2017, we noted further deterioration in the U.S. generics market and economic environments, which included additional pricing pressure in the U.S. generics market as a result of the customer consolidation to larger buying groups capable of extracting greater price reductions.

    在 2017 年第四季度,我們注意到美國仿製藥市場和經濟環境進一步惡化,其中包括美國仿製藥市場的額外定價壓力,因為客戶整合到能夠獲得更大降價的更大購買群體。

  • We also saw pricing challenges due to the government regulation, and a decrease in the value of our future launches as well as some other changes.

    由於政府監管,我們還看到了定價挑戰,以及我們未來發布的價值下降以及其他一些變化。

  • As a result of this, we've adjusted certain of our assumptions used in the cash flow projections of the fourth quarter of 2017 to determine the fair value of our U.S. generics reporting unit.

    因此,我們調整了我們在 2017 年第四季度現金流預測中使用的某些假設,以確定我們美國仿製藥報告部門的公允價值。

  • Based on this, we have recorded a goodwill of impairment of $11 billion related to our U.S. generics reporting unit in the fourth quarter of 2017.

    基於此,我們在 2017 年第四季度記錄了與我們的美國仿製藥報告部門相關的 110 億美元的商譽減值。

  • So turning to Slide 12.

    所以轉向幻燈片 12。

  • For the non-GAAP adjustments for the quarter, we had net adjustments of $12.5 billion.

    對於本季度的非公認會計原則調整,我們的淨調整為 125 億美元。

  • This includes the $11 billion impairment of goodwill that I just discussed related to our U.S. generics business as well as additional impairments of other long-lived assets of $3.2 billion, mainly related to a revaluation of generic products acquired from Actavis, discontinued Actavis generic products and Rimsa products as well as Teva-Takeda products and marketing rights for certain products.

    這包括我剛才討論的與我們的美國仿製藥業務相關的 110 億美元商譽減值,以及其他 32 億美元長期資產的額外減值,主要與從阿特維斯收購的仿製藥產品的重估、停產的阿特維斯仿製藥產品和Rimsa 產品以及 Teva-Takeda 產品和某些產品的營銷權。

  • And in addition, we also had an impairment of some property plant and equipment of about $302 million.

    此外,我們還對一些物業廠房和設備進行了約 3.02 億美元的減值。

  • Additionally, during the fourth quarter, we concluded that based on conditions in Venezuela, we are not deemed to have control over our subsidiaries, and this has led to a charge of nearly $400 million in connection with our deconsolidation of the results, and the primary driver of that is the cumulative currency translation adjustments we had related to Venezuela.

    此外,在第四季度,我們得出的結論是,根據委內瑞拉的情況,我們不被視為對我們的子公司擁有控制權,這導致了與我們取消合併結果相關的近 4 億美元的費用,以及主要驅動因素是我們與委內瑞拉相關的累積貨幣換算調整。

  • We also had a gain on tax-related items, primarily driven by the revaluation of our net deferred tax liabilities following the Tax Reform Act in the U.S. that was signed in December.

    我們還獲得了與稅收相關的項目的收益,這主要是由於在 12 月簽署的美國稅收改革法案之後對我們的淨遞延所得稅負債進行了重估。

  • So looking at our non-GAAP performance on Slide 13, we see a decline of revenues of $1 billion or roughly 16% compared to Q4 2016, which I will drill down to on the next slide.

    因此,看看我們在幻燈片 13 上的非 GAAP 表現,我們看到與 2016 年第四季度相比,收入下降了 10 億美元或大約 16%,我將在下一張幻燈片中深入研究。

  • What I would like to highlight here though is the fact that while sales are down significantly, our cost of goods are relatively flat.

    不過,我想在這裡強調的是,雖然銷售額大幅下降,但我們的商品成本相對持平。

  • This is mainly attributable to the low level of cost of goods associated with the revenue that declined significantly, mainly driven by price erosion in the U.S. generics, COPAXONE, the impact of Venezuela and the nonrecurring $150 million upfront payment we had from Takeda that we received in Q4 2017 that are in our revenues.

    這主要是由於與收入顯著下降相關的商品成本較低,這主要是由於美國仿製藥、COPAXONE 價格下跌、委內瑞拉的影響以及我們從武田收到的非經常性 1.5 億美元預付款所致在 2017 年第四季度,這是我們的收入。

  • The non-GAAP diluted EPS for the quarter was $0.93.

    本季度非公認會計原則攤薄後每股收益為 0.93 美元。

  • This is compared to our previously guided range of $0.70 to $0.80.

    這與我們之前指導的 0.70 美元至 0.80 美元的範圍相比。

  • The upside was the result of Teva's decision not to pay an annual bonus for 2017 due to the fact that the company's financial results were significantly below our original guidance for this year.

    有利因素是梯瓦決定不支付 2017 年的年度獎金,因為該公司的財務業績大大低於我們今年的原始指導。

  • As a result, there was a reversal of the amounts accrued for the bonus during the first 3 quarter and no accrual in Q4.

    因此,在前 3 個季度應計的獎金金額發生了逆轉,而在第 4 季度則沒有應計。

  • Still, without this benefit, our results would have been inside the range guided of $0.70 to $0.80 per share.

    儘管如此,如果沒有這種好處,我們的結果將在每股 0.70 美元至 0.80 美元的指導範圍內。

  • Lastly, cash flow from operations for the quarter came in higher than our previous guided range of $850 million to $1 billion, actually totaling $1.2 billion mainly due to the higher collections from customers.

    最後,本季度的運營現金流高於我們之前的指導範圍 8.5 億美元至 10 億美元,實際上總計 12 億美元,這主要是由於客戶的收款增加。

  • Turning to Slide 14.

    轉到幻燈片 14。

  • Revenues in the fourth quarter 2017 were $5.5 billion, down 16% compared to the fourth quarter of 2016.

    2017 年第四季度的收入為 55 億美元,與 2016 年第四季度相比下降了 16%。

  • This is primarily due to a decrease in the revenues of our specialty medicine segment due to generic competition for COPAXONE as well as the absence of the $150 million upfront payment from Takeda that we had in exchange for our royalties and other rights, and Ninlaro which was booked under revenue in the specialty segment in 2016.

    這主要是由於 COPAXONE 的仿製藥競爭導致我們的專科藥物部門的收入減少,以及我們沒有從武田(Takeda)獲得 1.5 億美元的預付款以換取我們的特許權使用費和其他權利,而 Ninlaro 2016 年在專業部門的收入項下入賬。

  • We also saw a decline in our U.S. generics business due to the challenging market dynamics in the U.S. generics market.

    由於美國仿製藥市場充滿挑戰,我們的美國仿製藥業務也出現下滑。

  • And lastly, adjustments of the exchange rate used for the Venezuelan bolivar compared to a year ago resulted in a net decrease of currency of $270 million, which is roughly $400 million decrease for Venezuela, offset by $130 million appreciation of other currencies.

    最後,與一年前相比,委內瑞拉玻利瓦爾使用的匯率調整導致貨幣淨減少 2.7 億美元,委內瑞拉減少約 4 億美元,被其他貨幣升值 1.3 億美元所抵消。

  • Turning to Slide 15.

    轉到幻燈片 15。

  • We saw a quarter-over-quarter drop in the non-GAAP operating income of 29%, mainly due to the reduced sales of COPAXONE, the exchange rate differences driven by Venezuela, but these were partially offset by the expense savings, including the reversal of bonus accrual I mentioned earlier.

    我們看到非 GAAP 營業收入環比下降 29%,主要是由於 COPAXONE 的銷售額減少、委內瑞拉推動的匯率差異,但這些都被費用節省部分抵消,包括逆轉我之前提到的應計獎金。

  • Turning to Slide 16.

    轉到幻燈片 16。

  • Global revenues of COPAXONE were $821 million, a decrease of 19% compared to the fourth quarter of 2016 and a decrease of over 17% compared to the third quarter of 2017, which was before the generic launch of Mylan 40 milligram generic in the United States.

    COPAXONE 的全球收入為 8.21 億美元,與 2016 年第四季度相比下降 19%,與邁蘭 40 毫克仿製藥在美國上市之前的 2017 年第三季度相比下降超過 17% .

  • In the U.S., the revenues were down to $622 million, which is 20% drop compared to the third quarter of 2017, mainly due to the generic competition which resulted in higher rebates and lower volumes.

    在美國,收入下降至 6.22 億美元,與 2017 年第三季度相比下降 20%,主要是由於仿製藥競爭導致更高的回扣和更低的銷量。

  • At the end of the fourth quarter of 2017, COPAXONE 40 milligram accounted for over 85% of total COPAXONE prescriptions in the U.S., and the revenues outside of the U.S. were $199 million.

    2017 年第四季度末,COPAXONE 40 毫克占美國 COPAXONE 處方總量的 85% 以上,美國以外的收入為 1.99 億美元。

  • Turning to Slide 17.

    轉到幻燈片 17。

  • We see the cash flow from operations and free cash flow was strong for the second straight quarter after several onetime payments in Q1 and Q2.

    在第一季度和第二季度多次付款後,我們看到運營現金流和自由現金流連續第二個季度強勁。

  • As I noted earlier, cash flow from operations benefited from slightly higher collections from customers, and I would note here that the free cash flow figures exclude any of the proceeds from divestitures, which we had $1.7 billion in Q4 of 2016 and $700 million in Q1 of 2017, as well as $1.8 billion in Q4 of 2018 related to the Women's Health sales.

    正如我之前提到的,來自運營的現金流受益於來自客戶的略微增加的收款,我在這裡要指出的是,自由現金流數據不包括資產剝離的任何收益,我們在 2016 年第四季度有 17 億美元,在第一季度有 7 億美元2017 年,以及 2018 年第四季度與女性健康銷售相關的 18 億美元。

  • We also had proceeds from the sale of Mylan shares earlier in the year of about $700 million.

    今年早些時候,我們還從出售 Mylan 股票中獲得了約 7 億美元的收益。

  • We expect to use the bulk of our free cash flow in 2018 to continue to reduce our outstanding debt.

    我們預計將在 2018 年利用我們的大部分自由現金流來繼續減少我們的未償債務。

  • Turning to Slide 18.

    轉到幻燈片 18。

  • A few items to highlight on the balance sheet.

    資產負債表上需要強調的一些項目。

  • We ended the year with approximately $1 billion in cash.

    我們在年底擁有大約 10 億美元的現金。

  • Meanwhile, we see significant declines in goodwill and intangible assets due to the impairments in the fourth quarter, which I have reviewed earlier in my presentation, mainly related to our U.S. generics business.

    與此同時,由於第四季度的減值,我們看到商譽和無形資產顯著下降,我在之前的演講中已經回顧過,主要與我們的美國仿製藥業務有關。

  • This led to a similar reduction in our shareholders' equity.

    這導致了我們股東權益的類似減少。

  • Also as previously noted, we did see a reduction in other long-term liabilities, due mainly to the gain on tax related to the deferred tax incomes following the tax reform in the U.S., and we also had a reduction in our debt that I will go in to in a few minutes.

    同樣如前所述,我們確實看到其他長期負債減少,這主要是由於美國稅制改革後與遞延所得稅相關的稅收收益,而且我們的債務也有所減少,我將幾分鐘後進去。

  • Turning to Slide 19.

    轉到幻燈片 19。

  • As of December 31, 2017, our debt was $32.5 billion, a decrease of $3.3 billion compared to the $35.8 billion at the end of 2016.

    截至 2017 年 12 月 31 日,我們的債務為 325 億美元,與 2016 年底的 358 億美元相比減少了 33 億美元。

  • The decrease was due to debt repayments of our term loans, our revolving credit facility and other short-term loans of approximately $4.5 billion, which were offset by foreign exchange fluctuations of $1.1 billion due to the strengthening mainly of the euro.

    減少的原因是我們償還了約 45 億美元的定期貸款、循環信貸額度和其他短期貸款,但主要由於歐元走強導致的 11 億美元的外匯波動抵消了這些債務。

  • We intend to reduce our debt further using the proceeds from a recently completed sale of the ex-U.

    我們打算利用最近完成的前美國出售所得來進一步減少我們的債務。

  • S. Women's Health business for roughly $703 million as well as the onetime payment of $700 million from Allergan that we will receive as a result of the recently announced settlement agreement.

    S. Women's Health 業務約 7.03 億美元,以及由於最近宣布的和解協議,我們將收到來自 Allergan 的一次性付款 7 億美元。

  • Payment of that is expected during the first quarter of [2018] (corrected by company after the call).

    預計在 [2018] 第一季度支付該款項(由公司在電話會議後更正)。

  • So turning now to the financial outlook.

    所以現在轉向財務前景。

  • Kåre has taken you through the numbers, but I think it's important to note some key assumptions that we have made in constructing this outlook.

    Kåre 為您介紹了這些數字,但我認為重要的是要注意我們在構建這一前景時所做的一些關鍵假設。

  • For revenues, there are 3 biggest factors are COPAXONE, U.S. generics and ProAir.

    對於收入,有 3 個最大的因素是 COPAXONE、美國仿製藥和 ProAir。

  • Global COPAXONE sales are expected to be approximately $1.8 billion in 2018.

    預計 2018 年全球 COPAXONE 銷售額約為 18 億美元。

  • This includes the ongoing erosion of the franchise from the recent generic competition and assumes a second generic launch of 40 milligram in the U.S. as early as April.

    這包括近期仿製藥競爭對特許經營權的持續侵蝕,並假設最早於 4 月在美國推出 40 毫克的第二次仿製藥。

  • U.S. generic sales consistent with the current segmentation are expected to be approximately $4 billion, a decline of roughly 20% versus 2017 due to ongoing price erosion in our base business as well as other products that have enjoyed periods of exclusivity, including the generic Concerta.

    與當前細分一致的美國仿製藥銷售額預計約為 40 億美元,與 2017 年相比下降約 20%,原因是我們的基礎業務以及其他享有排他期的產品(包括仿製藥 Concerta)的價格持續下降。

  • We also expect to see a generic competition for our ProAir franchise in the U.S. during the second half of the 2018.

    我們還希望在 2018 年下半年看到我們在美國的 ProAir 特許經營權的通用競爭。

  • For our spend base, I'd like to note that we expect to show a net decline of approximately $1.8 billion from $16.3 billion in 2017 to $14.5 billion in 2018.

    對於我們的支出基礎,我想指出,我們預計從 2017 年的 163 億美元到 2018 年的 145 億美元,淨減少約 18 億美元。

  • This is the result of cost-saving initiatives, the effect of divestments and partially offset by negative currency impacts due mainly to the strengthening dollar -- strengthening euro and shekel versus the dollar.

    這是節約成本舉措、撤資的結果,並被主要由於美元走強導致的負面貨幣影響部分抵消——歐元和謝克爾兌美元走強。

  • Additional assumptions on this include recent currency rates similar to those at the end of January 2018, which are roughly a dollar to euro -- a euro to dollar at $1.22 and the dollar to the Israeli shekel is ILS 3.41.

    對此的其他假設包括最近的匯率類似於 2018 年 1 月末的匯率,大致為 1 美元兌歐元——歐元兌美元為 1.22 美元,美元兌以色列謝克爾為 3.41 伊拉索。

  • We expect financing expenses to be around $900 million for the year, and our tax rate will be in the range of 17% to 19%, which reflects: one, the reduced sales of COPAXONE, which today benefits from a preferential tax rate; and two, the tax reform in the U.S., which is expected to have a negative impact on our overall rate due to the short -- in the short term due to the reforms kept on interest expense at 30% of EBIT in the U.S.

    我們預計全年融資費用在 9 億美元左右,我們的稅率將在 17% 到 19% 之間,這反映了:一是 COPAXONE 的銷售額減少,今天受益於優惠稅率;第二,美國的稅收改革,由於短期內預計將對我們的整體利率產生負面影響——在短期內,因為改革將利息費用保持在美國息稅前利潤的 30%。

  • Our cash flow from operations for 2018 will include 2 large onetime items that offset each other.

    我們 2018 年的運營現金流將包括兩個相互抵消的大型一次性項目。

  • The payment of $700 million by Allergan to Teva as a result of the recently announced settlement and approximately an expense -- cash expense of $800 million in restructuring cost due to the program that Kåre mentioned earlier.

    由於最近宣布的和解協議,Allergan 向 Teva 支付了 7 億美元,以及由於 Kåre 之前提到的計劃而產生的大約 8 億美元重組成本的現金支出。

  • We do expect capital expenditures during the year to be approximately $700 million, and we also expect our gross debt will be lowered by approximately $3.5 billion by the year-end 2018 coming from the free cash flow, the proceeds of the sale of the ex-U.

    我們確實預計今年的資本支出約為 7 億美元,我們還預計到 2018 年底,我們的總債務將減少約 35 億美元,來自自由現金流、出售前資產的收益。 ü。

  • S. Women's Health and other cash sources.

    S. 婦女健康和其他現金來源。

  • Lastly, the weighted average number of shares will be approximately 1,030,000,000.

    最後,加權平均股數約為 1,030,000,000 股。

  • This is driven partially by the fact that we will be suspending the cash dividend on our preferred shares, as the recent goodwill impairment leaves us in a situation where we no longer have a positive retained earnings, and we will not be paying the dividend in cash, but rather paying them as accumulation at the end of the conversion period in shares.

    這部分是由於我們將暫停優先股的現金股息,因為最近的商譽減值使我們處於不再擁有正的留存收益的情況下,我們將不會以現金支付股息,而是在轉換期結束時將其作為累積支付。

  • And that affects our share count over the course of 2018.

    這會影響我們在 2018 年的股票數量。

  • One last thing to note is that if we look at the quarters during the year, we're not going to give quarterly guidance, but due to the fact that we expect the second generic COPAXONE coming in April, you should expect Q1 to probably be the strongest of the year.

    最後要注意的一件事是,如果我們查看一年中的季度,我們不會提供季度指導,但由於我們預計第二個通用 COPAXONE 將在 4 月推出,您應該預計第一季度可能是年度最強。

  • At this point, I'd like to then turn it over to the operator and take us into the Q&A.

    這時,我想把它交給接線員,帶我們進入問答環節。

  • Operator

    Operator

  • (Operator Instructions) Your first question comes from the line of Douglas Tsao of Barclays.

    (操作員說明)您的第一個問題來自 Barclays 的 Douglas Tsao。

  • Douglas Dylan Tsao - Director and Senior Research Analyst

    Douglas Dylan Tsao - Director and Senior Research Analyst

  • Just in terms of the comments in the press release, you referenced some worsening of the U.S. generic market in the fourth quarter.

    就新聞稿中的評論而言,您提到了第四季度美國仿製藥市場的一些惡化。

  • Do you have a sense of the impact from the WBAD joining -- or ECONDISC joining WBAD.

    您是否了解加入 WBAD 或 ECONDISC 加入 WBAD 的影響。

  • And also just a comment, I might have missed in the prepared remarks, contributions from fremanezumab in the '18 guidance.

    還有一個評論,我可能在準備好的評論中錯過了 fremanezumab 在 18 年指南中的貢獻。

  • Kåre Schultz - Former CEO & President

    Kåre Schultz - Former CEO & President

  • Yes.

    是的。

  • Thanks for the questions.

    感謝您的提問。

  • I'll take the fremanezumab first and then Brendan will give you a review on the U.S. generics.

    我會先服用 fremanezumab,然後 Brendan 會給你一個關於美國仿製藥的評論。

  • In the guidance for 2018, fremanezumab basically has insignificant revenue, and that's simply because it's a launch that we are hoping to see sometime in the middle of the year and with a slow takeoff, which is the case for this new area where we'll see the expansion of the therapy, but not an existing market we're taking over.

    在 2018 年的指導中,fremanezumab 的收入基本上微不足道,這僅僅是因為我們希望在年中的某個時候看到它的推出,而且起步緩慢,這就是我們將在這個新領域的情況看到治療的擴展,但不是我們正在接管的現有市場。

  • We have very modest expectations -- insignificant expectations for the revenue.

    我們的預期非常溫和——對收入的預期微不足道。

  • However, it is an important product for us long term, since we believe that has huge potential in the migraine market.

    然而,從長遠來看,它對我們來說是一個重要的產品,因為我們相信它在偏頭痛市場具有巨大的潛力。

  • Brendan?

    布倫丹?

  • Brendan O'Grady - EVP of North America Commercial

    Brendan O'Grady - EVP of North America Commercial

  • Yes.

    是的。

  • Good morning, everybody.

    大家早上好。

  • And thanks for the question.

    感謝您的提問。

  • In regards to the U.S. generic market in the fourth quarter, I think it's just -- what we're continuing to see is the continued price erosion.

    關於第四季度的美國仿製藥市場,我認為這只是——我們繼續看到的是持續的價格侵蝕。

  • I don't think that ECONDISC joining the WBAD group had really much to do with that.

    我認為 ECONDISC 加入 WBAD 小組與此沒有太大關係。

  • It's just a continuation of what we've seen in the overall market.

    這只是我們在整個市場上看到的情況的延續。

  • Operator

    Operator

  • Your next question comes from the line of Louise Chen of Cantor.

    您的下一個問題來自 Cantor 的 Louise Chen。

  • Louise Alesandra Chen - Senior Research Analyst & MD

    Louise Alesandra Chen - Senior Research Analyst & MD

  • So first question I had was, what do you see as a longer-term vision for Teva and the growth drivers for Teva in 2019 and beyond?

    所以我的第一個問題是,您如何看待梯瓦的長期願景以及梯瓦在 2019 年及以後的增長動力?

  • If you could elaborate more on that, that would be very helpful.

    如果您能對此進行詳細說明,那將非常有幫助。

  • What are your pushes and pulls on the generic launch side for sales and earnings in 2018.

    您在 2018 年的銷售和收益方面對通用推出方面的推動和拉動是什麼?

  • And the last question is, how do you think you can achieve historical levels of sales growth with the cost cuts that you've implemented for Teva?

    最後一個問題是,您認為如何通過您為 Teva 實施的成本削減實現銷售增長的歷史水平?

  • Kåre Schultz - Former CEO & President

    Kåre Schultz - Former CEO & President

  • Thank you, Louise.

    謝謝你,路易絲。

  • I'll try and actually combine your first and last question and then Brendan will give some perspectives on the U.S. generics.

    我將嘗試將您的第一個和最後一個問題結合起來,然後 Brendan 將對美國仿製藥提出一些看法。

  • We think that we can return to historical growth after, you could say, the process of having COPAXONE go down in sales due to the generic competition and then having our new specialty products AUSTEDO and fremanezumab coming into the market and starting to accelerate into meaningful numbers.

    我們認為,在您可以說,由於仿製藥競爭導致 COPAXONE 銷售額下降,然後我們的新特色產品 AUSTEDO 和 fremanezumab 進入市場並開始加速進入有意義的數字的過程之後,我們認為我們可以恢復歷史增長.

  • At the same time, we believe we can stabilize our generics and OTC business worldwide and increase the margin on that business long term by simply having a more profit-oriented portfolio strategy for that whole business.

    同時,我們相信我們可以穩定我們在全球的仿製藥和非處方藥業務,並通過簡單地為整個業務制定更以利潤為導向的投資組合戰略來長期提高該業務的利潤率。

  • That does not mean that we expect to see significant revenue increases in our global generic business.

    這並不意味著我們預計我們的全球仿製藥業務收入會顯著增長。

  • But it does mean that we expect to see better margin developments over the coming years.

    但這確實意味著我們希望在未來幾年看到更好的利潤率發展。

  • So you would say we are sort of turning the strategy around from being a very volume-driven strategy to now being a much more profitability-driven strategy.

    因此,您會說我們正在將戰略從一個非常受銷量驅動的策略轉變為現在更加以盈利為導向的策略。

  • The combination of a stable generics segment with increasing profitability, and COPAXONE basically stabilizing at a significantly lower level than where it was a couple of years ago, and then the new specialty products taking off.

    穩定的仿製藥市場與不斷增加的盈利能力相結合,COPAXONE 基本上穩定在比幾年前低得多的水平,然後新的特種產品起飛。

  • That's really what makes us believe that we have a strong future ahead of us.

    這就是真正讓我們相信我們有一個強大的未來在我們面前的原因。

  • But, Brendan, over to you on the pulls and pushes for generics 2018.

    但是,布倫丹,在 2018 年仿製藥的拉動和推動上交給你。

  • Brendan O'Grady - EVP of North America Commercial

    Brendan O'Grady - EVP of North America Commercial

  • Yes.

    是的。

  • So if you continue to look at the generic market in the U.S. to 2018, I think that as Kåre mentioned, our goal is to stabilize the business.

    所以如果你繼續看美國的仿製藥市場到 2018 年,我認為正如 Kåre 所說,我們的目標是穩定業務。

  • It is to stabilize the base business.

    一是穩定基礎業務。

  • And as we work through that, we have significant launches planned in 2018.

    隨著我們的努力,我們計劃在 2018 年進行重大發布。

  • We've already executed 4 of those launches and we will continue to do that throughout the year.

    我們已經執行了其中的 4 次發布,並且我們將在全年繼續這樣做。

  • So I think, overall, the -- we're very optimistic about how the business will transform in '18 and -- as we get control of that.

    所以我認為,總的來說,我們對 18 年業務將如何轉變非常樂觀,並且隨著我們控制它。

  • Operator

    Operator

  • Our next question comes from the line of Vamil Divan of Crédit Suisse.

    我們的下一個問題來自瑞士信貸的 Vamil Divan。

  • Vamil Kishore Divan - Senior Analyst

    Vamil Kishore Divan - Senior Analyst

  • Just a little bit more on fremanezumab.

    關於fremanezumab的更多信息。

  • I know you said you're in dialogue with the FDA regarding the approval.

    我知道你說你正在與 FDA 就批准進行對話。

  • Is it produced at the same plant that Celltrion has the warning letter on?

    它是在 Celltrion 貼有警告信的同一家工廠生產的嗎?

  • Or is it at a different plant?

    還是在不同的工廠?

  • I'm just trying to understand your level of confidence, given the warning letter.

    鑑於警告信,我只是想了解您的信心水平。

  • And then the second one just more on the commercial side for that product.

    然後是該產品的第二個商業方面。

  • Curious if you can provide a little bit detail in terms of how you plan to present that commercially in terms of the type of device and the needle gauge?

    想知道您是否可以提供一點細節,說明您計劃如何在設備類型和針規方面進行商業展示?

  • I noticed in the trials that were published in New England Journal as well as 30% injection site reaction with that product similar to what was in placebo on that trial also.

    我注意到在《新英格蘭雜誌》上發表的試驗以及 30% 的注射部位反應與該試驗中的安慰劑相似。

  • But just curious if there is something that's going to change to bring those rates down in the real world?

    但只是好奇是否會發生一些變化以降低現實世界中的利率?

  • Kåre Schultz - Former CEO & President

    Kåre Schultz - Former CEO & President

  • Thanks for those questions, Vamil.

    感謝這些問題,瓦米爾。

  • I'll handle both of them.

    我會處理他們兩個。

  • First on the warning letter that Celltrion got is for a large facility, which both includes, a, part of the facility, which is producing API, and another part of the facility, which is doing finished pharmaceutical manufacturing.

    首先,Celltrion 收到的警告信是針對一家大型設施的,其中包括,a,生產 API 的設施的一部分,以及進行成品藥物製造的設施的另一部分。

  • And the comment in the warning letter and in the original 483 is really on the finished pharmaceutical part of the plant, which is what was inspected last summer when FDA inspected the plant.

    警告信和原始 483 中的評論實際上是關於工廠的成品製藥部分,這是去年夏天 FDA 檢查工廠時檢查的內容。

  • So you could say the warning letter and the comments have nothing to do with the API side, but it is the same huge manufacturing setup.

    所以你可以說警告信和評論與 API 方面無關,但它是同樣巨大的製造設置。

  • So it is the same plant, you could say, but 2 different parts of the plant.

    所以它是同一種植物,你可以說,但是植物的兩個不同部分。

  • We have had our own people there working with Celltrion.

    我們有自己的人在那裡與 Celltrion 合作。

  • We have had external experts there working with them securing that all the manufacturing of fremanezumab is done in perfect GLP conditions.

    我們有外部專家與他們合作,確保所有 fremanezumab 的製造都在完美的 GLP 條件下完成。

  • But, of course, it is an issue that they now have a warning letter and we need to see how we can reach an agreement on this with FDA and hopefully ensure that the PAI inspection of the API manufacturing will go ahead.

    但是,當然,他們現在有一封警告信是一個問題,我們需要看看我們如何才能與 FDA 就此達成協議,並希望確保 API 製造的 PAI 檢查能夠繼續進行。

  • And of course, all with the aim of keeping the PDUFA date for the product.

    當然,所有這些都是為了保持產品的 PDUFA 日期。

  • With regards to injections and the commercial outlook, we are very confident in the commercial outlook of fremanezumab.

    關於注射劑和商業前景,我們對fremanezumab的商業前景非常有信心。

  • As you might know, it is going to come in a completely sterilized syringe like most of antibodies come in the marketplace, and there'll be no problem doing self injection at home, if you want to do that, or go to a doctor and do there, if you want.

    正如您可能知道的那樣,它會像市場上的大多數抗體一樣裝在完全消毒的注射器中,如果您想這樣做,或者去看醫生,在家中進行自我注射也沒有問題在那裡做,如果你願意的話。

  • There's no issue there.

    那裡沒有問題。

  • And you always see some level of injection side reaction on all products, but this is nothing that is cause of concern for us.

    您總是會在所有產品上看到一定程度的注射副反應,但這並不是我們擔心的原因。

  • And it's comparable to what you see on other similar products.

    它與您在其他類似產品上看到的相當。

  • What we do see as a huge advantage is that we are the only ones in this marketing space that has a product base you can take 4 times a year.

    我們確實認為一個巨大的優勢是,我們是這個營銷領域中唯一擁有一年可以購買 4 次產品的公司。

  • That basically means that you can do this 4 days a year and then you don't have to worry about it the rest of the year, whereas the other products all only had once a month, which means basically 12 times a year and you need to go either to the doctor or the pharmacist or at home and take the injection.

    這基本上意味著你一年可以做 4 天,然後你不必擔心一年剩下的時間,而其他產品都只有一個月一次,這意味著基本上一年 12 次,你需要去看醫生或藥劑師或在家中註射。

  • So I think this injection flexibility and this injection reduced frequency of injections is a huge commercial advantage that we have.

    所以我認為這種注射靈活性和這種注射減少的注射頻率是我們擁有的巨大商業優勢。

  • And as you probably know, the efficacy on all of the products in development are similar.

    您可能知道,所有正在開發的產品的功效都是相似的。

  • There's no real difference there.

    那裡沒有真正的區別。

  • So having the same efficacy but significant more convenience, we think that would be a key edge for us in the marketplace.

    因此,具有相同的功效但更方便,我們認為這將是我們在市場上的關鍵優勢。

  • Operator

    Operator

  • Our next question comes from the line of Randall Stanicky of RBC Capital Markets.

    我們的下一個問題來自 RBC Capital Markets 的 Randall Stanicky。

  • Randall S. Stanicky - MD of Global Equity Research and Lead Analyst

    Randall S. Stanicky - MD of Global Equity Research and Lead Analyst

  • I just have a couple.

    我只有一對。

  • First, just based on the amended covenants, it implies or at least seems to imply that EBITDA will grow annually going forward.

    首先,僅基於修訂後的契約,它暗示或至少似乎暗示未來 EBITDA 將每年增長。

  • So I just want to confirm, is that the case?

    所以我只是想確認一下,是這樣嗎?

  • And then what type of growth are you looking for?

    然後你在尋找什麼類型的增長?

  • And where is that growth specifically coming from?

    這種增長具體來自哪裡?

  • Kåre Schultz - Former CEO & President

    Kåre Schultz - Former CEO & President

  • Thanks, Randall.

    謝謝,蘭德爾。

  • It's coming from what I explained before.

    它來自我之前解釋的內容。

  • Basically, you'll see a pressure next year from COPAXONE still losing sales due to generic erosion.

    基本上,明年你會看到 COPAXONE 的壓力仍然會因仿製藥侵蝕而失去銷售。

  • And then you'll see an uplift coming both from the top line in the form of AUSTEDO and fremanezumab, and then you'll see the uplift coming from the full implementation of the restructuring plan.

    然後你會看到 AUSTEDO 和 fremanezumab 形式的營收都出現了提升,然後你會看到重組計劃的全面實施帶來了提升。

  • So how that will exactly play out in detail in '19, it's difficult for me to quantify.

    那麼這將如何在 19 年詳細展開,我很難量化。

  • But it's quite clear that the basic business plan we have for the next 5 years is, of course, for these uplifts to overtake the downward pressure from the COPAXONE generics and thereby getting us back into situations where we are growing EBITDA.

    但很明顯,我們未來 5 年的基本業務計劃當然是讓這些提升來克服來自 COPAXONE 仿製藥的下行壓力,從而讓我們回到 EBITDA 增長的境地。

  • Randall S. Stanicky - MD of Global Equity Research and Lead Analyst

    Randall S. Stanicky - MD of Global Equity Research and Lead Analyst

  • Got it.

    知道了。

  • So just to be clear, EBITDA in 2019 and 2020, we should expect that to be growing?

    所以要明確一點,2019 年和 2020 年的 EBITDA,我們應該期望它會增長嗎?

  • And how about the revenue line?

    那麼收入線呢?

  • Kåre Schultz - Former CEO & President

    Kåre Schultz - Former CEO & President

  • So that's -- like I said, for '19, it's too early to say because you'll have 2 different things happening at the same time, but you will expect the cost will decrease, so the implementation of the restructuring plan will take the spend base down.

    所以這 - 就像我說的那樣,對於 19 年,現在說還為時過早,因為您將同時發生 2 件不同的事情,但您會期望成本會降低,因此重組計劃的實施將花費花費基地下來。

  • The specialty sales of AUSTEDO and fremanezumab will be increasing, and then we'll have a decrease of COPAXONE.

    AUSTEDO 和 fremanezumab 的專業銷售將增加,然後我們將有 COPAXONE 減少。

  • But I can't tell you how big it's going to be because that depends on how big will the downturn on COPAXONE be in 2018.

    但我不能告訴你它會有多大,因為這取決於 COPAXONE 在 2018 年的低迷幅度有多大。

  • And that means longer term, it's for sure that COPAXONE will stabilize.

    這意味著長期來看,COPAXONE 肯定會穩定下來。

  • The other 2 specialty products will be growing and will be reducing the spend base.

    其他 2 種特色產品將增長並減少支出基數。

  • That's why I'm answering that longer term, you'll see EBITDA growing, but it's hard for me right now to give you a specific number for 2019.

    這就是為什麼我要回答這個長期問題,你會看到 EBITDA 增長,但我現在很難給你一個 2019 年的具體數字。

  • Randall S. Stanicky - MD of Global Equity Research and Lead Analyst

    Randall S. Stanicky - MD of Global Equity Research and Lead Analyst

  • Got it.

    知道了。

  • Understood.

    明白了。

  • And then Kåre, can you just comment on your ability to just focus on BD to help support medium-term growth over the next couple of years?

    然後 Kåre,您能否評論一下您僅專注於 BD 以幫助支持未來幾年的中期增長的能力?

  • Kåre Schultz - Former CEO & President

    Kåre Schultz - Former CEO & President

  • Yes.

    是的。

  • That's a very short answer because we won't do any big structural BD at all because we don't have the cash to do it and we don't want to do it.

    這是一個非常簡短的答案,因為我們根本不會做任何大型的結構性 BD,因為我們沒有現金去做,我們也不想做。

  • We want to consolidate, integrate and pay down debt.

    我們希望鞏固、整合和償還債務。

  • We might do some small early-stage in-licensing, but that's not really big time BD and that's not a lot of money.

    我們可能會做一些小的早期階段許可,但這不是真正的大時代 BD,也不是很多錢。

  • So of course, we're looking constantly to in-license exciting products that 6 to 10 years from now can reach the marketplace.

    因此,當然,我們一直在尋求許可令人興奮的產品,這些產品可以在 6 到 10 年後進入市場。

  • Michael McClellan - Executive VP & CFO

    Michael McClellan - Executive VP & CFO

  • Yes.

    是的。

  • And Randall, I would add to what Kåre said that when you're looking at those covenants, also remember we're expecting to pay down significant amounts of debt over each of those years.

    蘭德爾,我想補充一下 Kåre 所說的話,當你查看這些契約時,還請記住,我們預計每年都會償還大量債務。

  • So that also helps with the leverage.

    所以這也有助於槓桿作用。

  • Operator

    Operator

  • Our next question comes from the line of Gregg Gilbert of Deutsche Bank.

    我們的下一個問題來自德意志銀行的 Gregg Gilbert。

  • Gregory B. Gilbert - MD and Senior Analyst

    Gregory B. Gilbert - MD and Senior Analyst

  • Couple of quick ones for Mike and then some generic questions.

    邁克的幾個快速問題,然後是一些一般性問題。

  • Mike, what nonoperating items, if any, are you including in the free cash flow guidance for '18?

    邁克,您在 18 年的自由現金流指導中包括哪些非經營性項目(如果有)?

  • And can you give us AUSTEDO sales in the quarter?

    你能告訴我們本季度的 AUSTEDO 銷售額嗎?

  • And then generically, I was hoping, Kåre, you could comment on in some more detail on the conversations you've been having with generic buyers on the subjective raising price versus discontinuation.

    然後一般來說,我希望,Kåre,你可以更詳細地評論你與普通買家就主觀提高價格與停產的對話。

  • And lastly, can you comment on your ability to file your generics Xifaxan again in the near term or ever?

    最後,您能否評論一下您在近期或將來再次提交仿製藥 Xifaxan 的能力?

  • And lastly, why didn't you get Lialda final, given that you are -- you had a tentative and it could have gone final as far as we know last month?

    最後,你為什麼沒有進入 Lialda 決賽,因為你是 - 你有一個試探性的,據我們上個月所知,它本可以進入決賽?

  • Michael McClellan - Executive VP & CFO

    Michael McClellan - Executive VP & CFO

  • So I'll take the first question.

    所以我會回答第一個問題。

  • So basically, the way we've framed free cash flow is basically our cash flow from operations less our net CapEx.

    所以基本上,我們構建自由現金流的方式基本上是我們的運營現金流減去我們的淨資本支出。

  • So the CapEx is reduced from that.

    因此,資本支出減少了。

  • If you look at special items in that free cash flow, we do include the $700 million we will get from the working capital settlement we did from Actavis -- from Allergan, but it will be offset by about $800 million of cash restructuring expenditure.

    如果您查看該自由現金流中的特殊項目,我們確實包括我們將從阿特維斯(來自艾爾建)的營運資金結算中獲得的 7 億美元,但這將被約 8 億美元的現金重組支出所抵消。

  • So otherwise, it's really pretty much consistent with the net income that you will see driven in the free cash flow.

    因此,否則,它實際上與您將看到的自由現金流驅動的淨收入非常一致。

  • Kåre Schultz - Former CEO & President

    Kåre Schultz - Former CEO & President

  • With regard to the discussion with the key buyers, then, of course, I've been involved in some of those discussions and they are very constructive and positive, but it's really Brendan who is, of course, on daily basis, close to the customers.

    關於與主要買家的討論,當然,我參與了其中一些討論,他們非常有建設性和積極性,但確實是 Brendan,當然,每天都接近顧客。

  • So I'll let Brendan give you some more light on that.

    所以我會讓布倫丹給你更多的信息。

  • Brendan O'Grady - EVP of North America Commercial

    Brendan O'Grady - EVP of North America Commercial

  • Yes.

    是的。

  • Thanks, Kåre.

    謝謝,卡雷。

  • So we've met with all 3 of the major customers and we continue to meet with our major customers, and I've explained the situation and what our intent there is.

    因此,我們已經會見了所有 3 個主要客戶,並且我們將繼續與我們的主要客戶會面,我已經解釋了情況以及我們的意圖。

  • And I think that we have a good positive relationship with all of them, the discussion, the discourse has been good.

    而且我認為我們與他們所有人都有很好的積極關係,討論、討論都很好。

  • And I suspect that we will wind up in 1 of 3 plays where there will be products where they will -- that are not profitable for us if they move to other suppliers.

    而且我懷疑我們將在 3 場比賽中的 1 場比賽中結束,在那裡他們將有產品——如果他們轉移到其他供應商,這些產品對我們來說是無利可圖的。

  • There is a group of products that we will be successful in increasing the price on to a profitable level.

    有一組產品我們將成功地將價格提高到可盈利的水平。

  • And there will be the third bucket of products that will work with our customers over a period of time to address this issue.

    第三批產品將在一段時間內與我們的客戶合作以解決這個問題。

  • Their goal here is not to create any shortages or disruptions in the market.

    他們的目標不是在市場上造成任何短缺或混亂。

  • And we pledge to do that with our customers.

    我們承諾與我們的客戶一起這樣做。

  • So I think we have a very good working relationship in -- as we move forward.

    所以我認為我們在前進的過程中有著非常好的工作關係。

  • Gregory B. Gilbert - MD and Senior Analyst

    Gregory B. Gilbert - MD and Senior Analyst

  • Can you say a few of the products?

    你能說幾個產品嗎?

  • Brendan O'Grady - EVP of North America Commercial

    Brendan O'Grady - EVP of North America Commercial

  • Yes.

    是的。

  • And on Lialda, we continue to work through the regulatory process, and we are working towards an approval and expect an approval on that product in 2018.

    在 Lialda 上,我們繼續通過監管程序,我們正在努力獲得批准,並希望在 2018 年獲得該產品的批准。

  • Gregory B. Gilbert - MD and Senior Analyst

    Gregory B. Gilbert - MD and Senior Analyst

  • And the Xifaxan filing lastly?

    最後是西法森的備案嗎?

  • Brendan O'Grady - EVP of North America Commercial

    Brendan O'Grady - EVP of North America Commercial

  • Yes.

    是的。

  • So we're in active discussions with the FDA on that as well and we'll see where that goes.

    因此,我們也在與 FDA 就這方面進行積極討論,我們會看看結果如何。

  • Operator

    Operator

  • Our next question comes from the line of Liav Abraham from Citi.

    我們的下一個問題來自花旗的 Liav Abraham。

  • Liav Abraham - Director

    Liav Abraham - Director

  • Just a couple of questions.

    只是幾個問題。

  • Firstly, given some of the comments that you made on your generics business in the U.S., can you just comment on what the pricing erosion was on the base business in Q4?

    首先,鑑於您對美國仿製藥業務的一些評論,您能否評論一下第四季度基礎業務的定價侵蝕是什麼?

  • And what your expectations are for U.S. base erosion of the generics business in 2018?

    您對 2018 年美國仿製藥業務的基礎侵蝕有何期望?

  • And then secondly, on the gross margin, just based on my calculations, the implied gross margin for 2018 based in your guidance is in the mid- to high 40% range.

    其次,在毛利率方面,僅根據我的計算,根據您的指導,2018 年的隱含毛利率在 40% 的中高範圍內。

  • Is that assumption reasonable?

    這個假設合理嗎?

  • And Mike, maybe some comment on the key drivers behind this compression versus 2017.

    邁克,也許對這種壓縮背後的關鍵驅動因素與 2017 年相比有一些評論。

  • I'm assuming it's predominantly COPAXONE and partly generics.

    我假設它主要是 COPAXONE 和部分仿製藥。

  • Can you comment on that?

    你能對此發表評論嗎?

  • Kåre Schultz - Former CEO & President

    Kåre Schultz - Former CEO & President

  • Let me start by a general comment on pricing and price erosion.

    讓我首先對定價和價格侵蝕進行一般性評論。

  • Going forward, we will no longer be giving specific comments on specific numbers for price erosion.

    展望未來,我們將不再對價格侵蝕的具體數字發表具體評論。

  • And I'd like to just take a little time to explain the logic behind that.

    我想花一點時間來解釋一下這背後的邏輯。

  • From a competitive point of view, sharing with your competitors and your customers details on your expected price development, to me, seems counterproductive from a competitive point of view.

    從競爭的角度來看,在我看來,與您的競爭對手和您的客戶分享您預期的價格發展的詳細信息,從競爭的角度來看似乎適得其反。

  • So this is partly maybe the reason for the downward spirals in the generics marketplace.

    因此,這可能是仿製藥市場呈螺旋式下降的部分原因。

  • It's like, if you say it's 10%, everybody will ask for 12%.

    就像,如果你說是 10%,每個人都會要求 12%。

  • If you say it's 15%, everybody will ask for 17%.

    如果你說是 15%,每個人都會要求 17%。

  • And in my mind, that doesn't help our business.

    在我看來,這對我們的業務沒有幫助。

  • So going forward, we won't give any specific numbers on this, and I think that will help us stabilize the business.

    因此,展望未來,我們不會就此提供任何具體數字,我認為這將有助於我們穩定業務。

  • And we won't give you the details either on exactly how much is being discontinued, how much is being repriced and how we're seeing the overall price development.

    我們也不會向您詳細說明停產的具體數量、重新定價的數量以及我們如何看待整體價格的發展。

  • We will, of course, share with you every quarter the realized numbers, and we will also share with you broadly the total outlook we are expecting, but none of these pricing details.

    當然,我們將在每個季度與您分享已實現的數字,我們還將與您廣泛分享我們預期的總體前景,但沒有這些定價細節。

  • However, we don't have any problems with sharing what we talked about last year, and Brendan, you can give a comment on the Q4 erosion.

    但是,我們在分享去年討論的內容時沒有任何問題,布倫丹,您可以對第四季度的侵蝕發表評論。

  • Brendan O'Grady - EVP of North America Commercial

    Brendan O'Grady - EVP of North America Commercial

  • Yes.

    是的。

  • So the Q4 erosion was pretty much in line with industry expectations, about 13%.

    因此,第四季度的侵蝕幾乎符合行業預期,約為 13%。

  • Michael McClellan - Executive VP & CFO

    Michael McClellan - Executive VP & CFO

  • Yes.

    是的。

  • So I can take the question on overall gross margin.

    所以我可以回答關於整體毛利率的問題。

  • So if you look at Teva as a whole, our expectations of gross margin percentage are roughly 50% next year.

    因此,如果您將 Teva 視為一個整體,我們對明年毛利率的預期約為 50%。

  • It's -- versus full year in 2017, we were closer to 55%.

    這是 - 與 2017 年全年相比,我們接近 55%。

  • The 5 percentage point drop is driven mainly by pricing pressure on COPAXONE as well as pricing pressure in the U.S. generics.

    下降 5 個百分點的主要原因是 COPAXONE 的定價壓力以及美國仿製藥的定價壓力。

  • We also see a little bit of a currency impact there.

    我們還看到了一些貨幣影響。

  • You do have the results of the divested businesses coming out.

    您確實有剝離業務的結果。

  • But the majority of the 4-point erosion is really pricing on COPAXONE and the price erosion on U.S. generics, the base and the transition including Concerta.

    但 4 點侵蝕的大部分實際上是對 COPAXONE 的定價以及對美國仿製藥、基礎和包括 Concerta 在內的過渡的價格侵蝕。

  • Operator

    Operator

  • Our next question comes from the line of Umer Raffat of Evercore.

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

  • Umer Raffat - Senior MD & Fundamental Research Analyst

    Umer Raffat - Senior MD & Fundamental Research Analyst

  • I guess, I wanted to focus on CGRP and ask, is it typical to have only 1 API source on a high-priority program like this?

    我想,我想專注於 CGRP 並問,在這樣的高優先級程序上通常只有 1 個 API 源嗎?

  • And how long would it take to either sign up a new API or resolve this warning letter?

    註冊一個新的 API 或解決這個警告信需要多長時間?

  • And then, if I may, what were the AUSTEDO sales in 4Q?

    然後,如果可以的話,AUSTEDO 第四季度的銷售額是多少?

  • Kåre Schultz - Former CEO & President

    Kåre Schultz - Former CEO & President

  • Thank you, Umer.

    謝謝你,烏默爾。

  • So on the CGRP, we are planning to have more than one source.

    因此,在 CGRP 上,我們計劃擁有多個來源。

  • At this one moment, we only have 1 source, which is Celltrion.

    目前,我們只有 1 個來源,即 Celltrion。

  • But we are planning to have actually one more supplier coming up and we're also building our own capacity.

    但我們實際上計劃再增加一個供應商,我們也在建立自己的能力。

  • So longer term, we will have 2 suppliers.

    所以從長遠來看,我們將有 2 個供應商。

  • The second supplier is not ready right now.

    第二個供應商現在還沒有準備好。

  • So we really have to resolve this together with the FDA and Celltrion.

    所以我們真的必須與 FDA 和 Celltrion 一起解決這個問題。

  • And we're optimistic that we can do that.

    我們很樂觀地認為我們可以做到這一點。

  • If you think about how long it typically takes to resolve that warning letter, then you can say we've just done it ourselves in China successfully right now.

    如果您考慮解決該警告信通常需要多長時間,那麼您可以說我們現在自己在中國成功地完成了。

  • And I would say, typically, it can take anywhere from 6 to 18 months to do it.

    我想說,通常情況下,它可能需要 6 到 18 個月才能完成。

  • That would be sort of a normal take on it.

    這將是一種正常的看法。

  • And then it's a little different to see from the day of the original inspection report or the day of warning letter, that depends on how active you've been working on it since the day you got the 483.

    然後從原始檢查報告的那天或警告信的那天看到有點不同,這取決於你從拿到 483 那天起的工作活躍程度。

  • So that is roughly the time lines that we are talking on.

    所以這大致是我們正在討論的時間線。

  • On AUSTEDO sales in Q4, I'll let Brendan comment on that.

    關於第四季度的 AUSTEDO 銷售,我會讓 Brendan 對此發表評論。

  • Brendan O'Grady - EVP of North America Commercial

    Brendan O'Grady - EVP of North America Commercial

  • Yes.

    是的。

  • So AUSTEDO sales in Q4 were in line with the expectations and were $17 million.

    因此,AUSTEDO 在第四季度的銷售額符合預期,為 1700 萬美元。

  • Umer Raffat - Senior MD & Fundamental Research Analyst

    Umer Raffat - Senior MD & Fundamental Research Analyst

  • Kåre, if I may, are you saying AUSTEDO should -- sorry, are you saying CGRP should be approved 16 months -- 16 to 18 months from now?

    Kåre,如果我可以的話,您是說AUSTEDO 應該- 抱歉,您是說CGRP 應該在16 個月- 從現在起16 到18 個月後獲得批准?

  • Or do you think your second API will kick in before that?

    或者您認為您的第二個 API 會在此之前啟動嗎?

  • Kåre Schultz - Former CEO & President

    Kåre Schultz - Former CEO & President

  • No, I'm not saying that.

    不,我不是這麼說的。

  • First of all, what I'm saying is that the inspection that happened at Celltrion was in their finished pharmaceutical manufacturing, where they do the filling of products and the finished products.

    首先,我要說的是,在 Celltrion 發生的檢查是在他們的成品藥品製造中,他們在那裡進行產品的灌裝和成品。

  • The part of the factory doing the API was not inspected and didn't have any warning letter or any comments to it because it wasn't inspected.

    工廠做 API 的部分沒有被檢查,也沒有任何警告信或任何評論,因為它沒有被檢查。

  • We are working now to have a stand-up PAI inspection in connection with our file just like we've had the finished manufacturing is being inspected right now.

    我們現在正在努力對我們的文件進行站立式 PAI 檢查,就像我們現在正在檢查成品一樣。

  • That's actually with a supplier in Europe.

    這實際上與歐洲的供應商有關。

  • And the clinical sites are also being inspected by FDA, so they're working diligently on this file.

    並且臨床站點也正在接受 FDA 的檢查,所以他們正在努力處理這個文件。

  • So in that respect, we hope that we can have a PAI of the API in Celltrion, and based on that, we can go into the marketplace.

    所以在這方面,我們希望我們可以在 Celltrion 中擁有 API 的 PAI,並在此基礎上進入市場。

  • So it all remains to be seen how it plays out, but I'm not saying that it will be 18 months from now.

    所以這一切還有待觀察,但我並不是說這將是從現在開始的 18 個月。

  • Operator

    Operator

  • Our next question comes from the line of Jami Rubin of Goldman Sachs.

    我們的下一個問題來自高盛的 Jami Rubin。

  • Jamilu E. Rubin - Equity Analyst

    Jamilu E. Rubin - Equity Analyst

  • Just have a couple.

    就來一對吧。

  • Mike, if you can just be a little bit more explicit on your year-end net debt forecast?

    邁克,您能否對年終淨債務預測再明確一點?

  • You said you would be lowering it by $3.5 billion, but that's what -- from what, I think you ended 2017 at $32.5 billion, but when we read the press release last week, you had started to bring that down to around $30 billion.

    你說你會降低 35 億美元,但這就是 - 從什麼開始,我認為你在 2017 年結束時為 325 億美元,但當我們上週閱讀新聞稿時,你已經開始將其降低到 300 億美元左右。

  • So where we're going to end at the end of this year?

    那麼今年年底我們將在哪裡結束呢?

  • And if you could kind of talk about the past 2 net debt reduction going forward.

    如果你能談談過去的 2 次淨債務削減。

  • And there's just another question.

    還有一個問題。

  • You just announced that you amended your covenants to now 5.9x from 5x and typically companies provide themselves with some cushion.

    您剛剛宣布您將契約從 5 倍修改為現在的 5.9 倍,通常公司會為自己提供一些緩衝。

  • But if I take the midpoint of your EBITDA guidance this year of $4.85 billion and apply that to a net debt number of, say, $28 billion, $29 billion and again, that's where I need your help.

    但是,如果我將你今年 EBITDA 指導的中點 48.5 億美元應用到淨債務數量上,比如 280 億美元、290 億美元,那麼這就是我需要你幫助的地方。

  • I'm getting at about 5.7 to 5.9x brushing up against your just announced amendment.

    我正在以大約 5.7 到 5.9 倍的速度來反對你剛剛宣布的修正案。

  • And just wondering, if I'm looking at that correctly, whether you want to have a little bit more cushion there?

    只是想知道,如果我沒看錯的話,你是否想在那裡多放一點緩衝?

  • And then secondly, Kåre, if you could again be a little bit more explicit on timing of fremanezumab, that 16 months from what?

    其次,Kåre,如果你能再對 fremanezumab 的時間更明確一點,那 16 個月後是什麼?

  • From the original 483 letter?

    來自最初的 483 信?

  • If you can just put that 16 to 18 months in perspective?

    如果你能把這 16 到 18 個月的時間放在眼裡?

  • And what is -- how likely is it that this fremanezumab could be launched on a timely basis?

    什麼是——這種fremanezumab 及時推出的可能性有多大?

  • It seems like that would be pretty low.

    這似乎會很低。

  • Michael McClellan - Executive VP & CFO

    Michael McClellan - Executive VP & CFO

  • So I'll take the first couple of questions and then I'll turn it over to Kåre.

    因此,我將回答前幾個問題,然後將其交給 Kåre。

  • So our year-end gross debt in our slides was $32.5 billion and we had about $1 billion of cash.

    因此,我們幻燈片中的年終總債務為 325 億美元,我們有大約 10 億美元的現金。

  • So a net debt of $31.5 billion at the end of 2017.

    因此,2017 年底的淨債務為 315 億美元。

  • We do expect to pay down at least $3.5 billion that's driven by the free cash flow that you see in our guidance plus the $700 million from the ex-U.

    我們確實預計至少支付 35 億美元,這是由您在我們的指導中看到的自由現金流加上來自前美國的 7 億美元推動的。

  • S. Women's Health sales that's not in the free cash flow.

    S. 不屬於自由現金流的女性健康銷售。

  • We will also look on top of that to see if we do additional asset divestments.

    我們還將在此基礎上查看是否進行額外的資產剝離。

  • We haven't put that in the outlook because we're still in the middle of looking at what could be of value to divest, but that is also part of our plans.

    我們沒有把它放在前景中,因為我們仍在研究哪些可能有價值的剝離,但這也是我們計劃的一部分。

  • If you look at the amended covenants, you're right that we did put it up at 5.9x.

    如果您查看修訂後的契約,您是對的,我們確實將其設置為 5.9 倍。

  • We agreed the covenants a couple weeks ago.

    幾週前我們達成了盟約。

  • In the meantime, we got the surprise news that the Pfizer plant that had been under a warning letter might come online a little bit earlier for a potential second COPAXONE 40 milligram generic.

    與此同時,我們得到了一個令人驚訝的消息,輝瑞(Pfizer)公司收到警告信的工廠可能會提前一點上線,以獲得潛在的第二個 COPAXONE 40 毫克仿製藥。

  • We still feel comfortable with our covenants, especially given the fact that we could do some asset divestments in 2018, but it's clear that we did need to move the covenants up.

    我們仍然對我們的契約感到滿意,特別是考慮到我們可以在 2018 年進行一些資產剝離,但很明顯我們確實需要提升契約。

  • We feel very confident in that.

    我們對此感到非常有信心。

  • We have a great relationship with our banking partners and that they gave us a wonderful support there.

    我們與銀行合作夥伴有著良好的關係,他們在那里為我們提供了極好的支持。

  • But it's something we're going have to manage very closely as we go into the rest of 2018.

    但隨著我們進入 2018 年剩餘時間,這是我們必須非常密切地管理的事情。

  • And then when we really start to see more of the restructuring plan in '19, that should give us an additional cash flow to help pay down debt.

    然後,當我們真正開始在 19 年看到更多的重組計劃時,這應該會給我們帶來額外的現金流來幫助償還債務。

  • So -- and we feel confident, but there are things that we will be having to look at.

    所以 - 我們感到自信,但有些事情我們將不得不考慮。

  • And we will be looking to see if additional minor divestments can help pay down debt even more rapidly in 2018.

    我們將關注額外的小額撤資是否有助於在 2018 年更快地償還債務。

  • Kåre Schultz - Former CEO & President

    Kåre Schultz - Former CEO & President

  • And then Jami, I think maybe I didn't make it clear and maybe it was mispronounced by me.

    然後是 Jami,我想也許我沒有說清楚,也許是我讀錯了。

  • I said 6 to 18.

    我說6到18。

  • So 06 to 18 months.

    所以06到18個月。

  • It's typically the time it takes to close out a warning letter.

    這通常是關閉警告信所需的時間。

  • So not 16 to 18, but 6 to 18.

    所以不是16到18,而是6到18。

  • But that being said, the situation is a little more complex than it would normally be if it was just a warning letter on our manufacturing, because this is a warning letter on some manufacturing which is not related to our product because it's in the part of the factory that does the filling of finished products and so on.

    但是話雖這麼說,情況比通常情況下要復雜一些完成成品灌裝的工廠等等。

  • And we are in part of the factory where you do biologics, API manufacturing.

    我們在您進行生物製劑、API 製造的工廠的一部分。

  • So that's why I'm saying given the fact that we have used a voucher and that the FDA is doing everything possible so far to work in the PDUFA date of mid-June, we're, of course, in dialogue with them how we can ensure a PAI of the actual API manufacturing of fremanezumab at Celltrion.

    所以這就是為什麼我這麼說的原因,鑑於我們已經使用了代金券並且 FDA 正在盡一切可能在 6 月中旬的 PDUFA 日期工作,當然,我們正在與他們進行對話,我們如何可以確保在 Celltrion 生產 fremanezumab 的實際 API 的 PAI。

  • Now if we can secure that and if that goes through without problems based on all the work we have done, our quality people, there'll be Celltrion's quality people and of course, there'll be no delay of fremanezumab.

    現在,如果我們能夠確保這一點,並且如果基於我們所做的所有工作、我們的優質人員、Celltrion 的優質人員,並且毫無問題地順利進行,那麼 fremanezumab 就不會延遲。

  • On the other hand, if something pops up, and if there are some other issues, then there could be a delay.

    另一方面,如果出現某些問題,並且還有其他問題,則可能會出現延遲。

  • But I didn't say 16 to 18, I said 6 to 18.

    但我沒有說 16 到 18,我說的是 6 到 18。

  • And that would be from the date of receiving the actual warning letter.

    那將是從收到實際警告信之日起。

  • I hope that answers your question.

    我希望這能回答你的問題。

  • Operator

    Operator

  • Our next question comes from the line of Ken Cacciatore of Cowen and Company.

    我們的下一個問題來自 Cowen and Company 的 Ken Cacciatore。

  • Kenneth Charles Cacciatore - MD and Senior Research Analyst

    Kenneth Charles Cacciatore - MD and Senior Research Analyst

  • Just have 1 question on fremanezumab.

    只有 1 個關於 fremanezumab 的問題。

  • Your competitors are going to be launching with auto injectors.

    您的競爭對手將推出自動注射器。

  • Just wondering -- and you're indicating you're going to launch with the prefilled syringe.

    只是想知道 - 您表示您將使用預填充注射器啟動。

  • Are you working on an auto injector?

    你在做自動注射器嗎?

  • The products, I don't think, are that differentiated.

    我不認為這些產品有那麼不同。

  • So just little things could matter.

    所以只是小事可能很重要。

  • Just want to know if you are working to try to put your product into an auto injector?

    只是想知道您是否正在嘗試將您的產品放入自動注射器?

  • Kåre Schultz - Former CEO & President

    Kåre Schultz - Former CEO & President

  • Yes.

    是的。

  • There is very simple answer.

    有非常簡單的答案。

  • Yes, we are.

    是的,我們是的。

  • And we expect to have one within sort of -- we're launching in the short future.

    我們預計會有一個——我們將在不久的將來推出。

  • I don't think it's a huge difference and especially not for that segment who would like to have injections only 4 times a year.

    我不認為這是一個巨大的差異,尤其是對於那些希望一年只注射 4 次的那部分人來說。

  • You would probably decide to go to the doctors to begin with and have the injections at a clinic, and it's a standard prefilled syringe we have.

    您可能會決定先去看醫生並在診所進行注射,這是我們擁有的標準預充式註射器。

  • It's no different from what's being used by millions of people every day.

    它與每天被數百萬人使用的東西沒有什麼不同。

  • So we don't see it as a big issue for us, but of course, we will also have an auto injector.

    所以我們不認為這對我們來說是一個大問題,但當然,我們也會有一個自動注射器。

  • Operator

    Operator

  • Your next question comes from David Maris of Wells Fargo.

    您的下一個問題來自富國銀行的 David Maris。

  • David William Maris - Senior Analyst

    David William Maris - Senior Analyst

  • A few questions.

    幾個問題。

  • So first, what are the number of products that you've cut that were unprofitable and the number of products that you raised prices on so far?

    那麼首先,到目前為止,你削減了多少無利可圖的產品,以及你提高了價格的產品數量?

  • Secondly, on R&D expenses were down quite a bit.

    其次,研發費用下降不少。

  • Can you just walk through or give us some color on where those cuts are coming from?

    你能簡單地走過或給我們一些關於這些削減來自哪裡的顏色嗎?

  • How you determined what to cut?

    你是如何決定要剪什麼的?

  • And why investors shouldn't look at this and think that, that kind of impairs the growth going forward?

    為什麼投資者不應該看到這一點並認為這會損害未來的增長?

  • And then lastly, does the 2018 guidance assume debt refinancing of the near-term maturities?

    最後,2018 年的指引是否假設近期到期的債務再融資?

  • Kåre Schultz - Former CEO & President

    Kåre Schultz - Former CEO & President

  • So I'll take the 2 first ones and Mike can take the one about the debt.

    所以我會拿前兩個,邁克可以拿關於債務的那個。

  • So in terms of the number of products, it's too early to say because we are right now in dialogue with our key customers and of course, we are discussing with them, like Brendan said, the options of either us adjusting the price and making them profitable again or us getting out of the contracts on them in a timely manner.

    因此,就產品數量而言,現在說還為時過早,因為我們現在正在與我們的主要客戶進行對話,當然,我們正在與他們討論,就像 Brendan 所說,我們調整價格並製造它們的選擇再次盈利,或者我們及時退出他們的合同。

  • But of course, we won't leave to any patients with our products.

    但當然,我們不會將我們的產品留給任何患者。

  • We won't sort of leave any customers without supplies, and typically our contracts are for an average of 6 months into the future.

    我們不會讓任何客戶沒有供應,而且通常我們的合同平均為未來 6 個月。

  • So this is something we can tell you more about once this year has passed, but we can't really tell you the outcome right now.

    所以這是我們可以在今年過去後告訴你更多的事情,但我們現在不能真正告訴你結果。

  • With regard to R&D, I alluded to it a little bit by explaining that we have cut roughly 25 projects in our sort of the branded specialty R&D, that's roughly 27% of our context.

    關於研發,我通過解釋說我們已經削減了大約 25 個項目在我們的品牌專業研發中,這大約是我們上下文的 27%。

  • And basically what we have done is, we've looked at where our core capabilities are, our core skills and kept all projects in those areas.

    基本上我們所做的是,我們已經研究了我們的核心能力,我們的核心技能,並將所有項目都保留在這些領域。

  • So these are the areas, of course, of neurology, CNS and so on.

    當然,這些是神經病學、中樞神經系統等領域。

  • And then we have said the more sort of blue ocean, more creative high-risk projects.

    然後我們說了更多藍海,更有創意的高風險項目。

  • Those we're taking out.

    我們要取出的那些。

  • If you look historically, then Teva has been very successful on taking good ideas within the space of neurology and CNS into its pipeline from other research organizations and then develop the projects, whereas it has not been our strength to do the basic research.

    如果你回顧歷史,那麼 Teva 已經非常成功地將神經病學和 CNS 領域內的好想法從其他研究機構引入其管道,然後開發項目,而做基礎研究並不是我們的強項。

  • And that means some of the projects where we've been doing basic research and where it's very sort of far away from our core competencies, we've decided to close those.

    這意味著我們一直在進行基礎研究並且與我們的核心競爭力相距甚遠的一些項目,我們決定關閉這些項目。

  • And I think it won't really hurt the return on investment on our R&D investments and it won't hurt the future outlook of the company.

    而且我認為這不會真正損害我們研發投資的投資回報,也不會損害公司的未來前景。

  • In the space of generics, what we've done is, we've started to look at it more from a portfolio point of view.

    在泛型領域,我們所做的是,我們已經開始更多地從投資組合的角度來看待它。

  • So look at the portfolio of NDAs, we had the portfolios of our ANDAs, we have -- which of these are the most valuable and which of these are very marginal in value, and thereby giving a more profitability-oriented way of building up our portfolio of generics projects.

    所以看看 NDA 的投資組合,我們有 ANDA 的投資組合,我們有 - 其中哪些是最有價值的,哪些是非常邊緣的,從而提供了一種更加以盈利為導向的方式來建立我們的仿製藥項目組合。

  • Michael McClellan - Executive VP & CFO

    Michael McClellan - Executive VP & CFO

  • Yes.

    是的。

  • So when it comes to the 2018 outlook and debt refinancing, couple of things I would note here is that you may have noticed that we filed an S3 a couple of weeks ago.

    因此,當談到 2018 年的前景和債務再融資時,我要在這裡指出的幾件事是,您可能已經註意到我們在幾週前提交了 S3。

  • That is just normal and good corporate governance.

    這只是正常和良好的公司治理。

  • We didn't have an active S3 at that time.

    當時我們沒有活躍的 S3。

  • But it is giving us eventually the opportunity to potentially come to the market with some debt offerings.

    但這最終使我們有機會通過一些債務產品潛在地進入市場。

  • Looking at our cash flows going forward and our debt maturities in the coming years, we are actively looking at potentially doing some refinancing of the near term.

    著眼於我們未來的現金流和未來幾年的債務到期情況,我們正在積極考慮可能在短期內進行一些再融資。

  • And the finance expenses that I mentioned in my 2018 outlook assumptions do include a little bit of an extra interest expense assumption for some minor refinancing in the $3 billion to $4 billion range, if we decide to do it.

    如果我們決定這樣做,我在 2018 年展望假設中提到的財務費用確實包括一些額外的利息費用假設,用於 30 億至 40 億美元範圍內的一些小額再融資。

  • Operator

    Operator

  • Our next question comes from the line of Ronny Gal of Bernstein.

    我們的下一個問題來自 Bernstein 的 Ronny Gal。

  • Aaron Gal - Senior Research Analyst

    Aaron Gal - Senior Research Analyst

  • I'm going to touch, if you don't mind, if presenting that first, which is, is the facility that Celltrion have pays 2 facilities fees, one for the API and one for the filled finish?

    如果你不介意的話,我會說一下,如果首先介紹,即 Celltrion 擁有的設施是否支付 2 項設施費用,一項用於 API,另一項用於填充完成?

  • Or is it essentially 1 facility fee because obviously that will depends -- move things regulatorily?

    或者它本質上是 1 設施費,因為顯然這將取決於 - 以監管方式移動事物?

  • And second, your CapEx is still running around $700 million.

    其次,您的資本支出仍然在 7 億美元左右。

  • It's been a long debate why Teva's CapEx is so much above other generic companies.

    為什麼梯瓦的資本支出遠高於其他仿製藥公司,這是一個長期的爭論。

  • Is this something that you're seeing opportunity to bring to like the $400 million or $500 million level overtime?

    這是你看到的機會,比如加班費達到 4 億美元或 5 億美元嗎?

  • Or is there still something that you expect to stay above kind of like industry norm longer term?

    或者您是否仍然希望長期保持在行業規範之上?

  • Michael McClellan - Executive VP & CFO

    Michael McClellan - Executive VP & CFO

  • Ronny, can you just clarify in your second question what is you're referring to again on the $700 million?

    羅尼,您能否在第二個問題中澄清一下您在 7 億美元中再次指的是什麼?

  • Aaron Gal - Senior Research Analyst

    Aaron Gal - Senior Research Analyst

  • The CapEx, capital expenses, sorry.

    資本支出,資本支出,對不起。

  • Michael McClellan - Executive VP & CFO

    Michael McClellan - Executive VP & CFO

  • CapEx, okay.

    資本支出,好的。

  • Kåre Schultz - Former CEO & President

    Kåre Schultz - Former CEO & President

  • So let me comment on the fremanezumab and the Celltrion facility.

    所以讓我評論一下fremanezumab和Celltrion設施。

  • So the facility from a regulatory part of view is the same facility.

    因此,從監管部分的角度來看,該設施是同一設施。

  • It's a huge facility, but the part of the facility that was inspected was the finished and packed manufacturing site not the API part of the site.

    這是一個巨大的設施,但被檢查的設施部分是完成和包裝的製造現場,而不是現場的 API 部分。

  • But from a regulatory point of view, it's the same facility site now so to speak.

    但從監管的角度來看,現在可以說是同一個設施站點。

  • Aaron Gal - Senior Research Analyst

    Aaron Gal - Senior Research Analyst

  • Got it.

    知道了。

  • So if you kind of look at that and look at the fact that the letter came to Celltrion on January 26 and they're telling them to higher consultants and view couple of independent assessment of compliance in that letter, is it realistic this will come in, in 6 months because they kind of look at this and just going to cycle time to do that has to be a little bit longer than that.

    所以,如果你看一下,看看這封信於 1 月 26 日寄給 Celltrion 的事實,他們告訴他們更高的顧問,並在這封信中查看對合規性的獨立評估,這是否現實? ,在 6 個月內,因為他們有點看這個,只是要循環時間來做這必須比那個長一點。

  • Kåre Schultz - Former CEO & President

    Kåre Schultz - Former CEO & President

  • Yes, but the key issue for us is not exactly what timing it takes to close out that warning letter.

    是的,但對我們而言,關鍵問題並不完全是關閉該警告信所需的時間。

  • The key issue here is that our manufacturing of API is happening in a completely separate part of the facility, which was not inspected by the FDA.

    這裡的關鍵問題是,我們的 API 生產是在設施的一個完全獨立的部分進行的,沒有經過 FDA 的檢查。

  • So we will, of course, be in a dialogue with FDA, where we can hopefully conclude that it's a good idea to inspect that part in a PAI inspection and then based on the result of that, whether we can get the approval on time.

    因此,當然,我們將與 FDA 進行對話,希望我們可以得出結論,在 PAI 檢查中檢查該部分是一個好主意,然後根據結果,我們是否可以按時獲得批准。

  • But that all remains to be seen and we'll be in a dialogue with FDA about it.

    但這一切還有待觀察,我們將就此事與 FDA 進行對話。

  • Michael McClellan - Executive VP & CFO

    Michael McClellan - Executive VP & CFO

  • Yes.

    是的。

  • Ronny, I can take your question on CapEx.

    羅尼,我可以回答你關於資本支出的問題。

  • The $700 million in CapEx we planned for 2018 is actually a decrease from this year.

    我們為 2018 年計劃的 7 億美元資本支出實際上比今年有所減少。

  • Though -- and it would have went down even further except we are spending a sizable amount to build the biologics plant in Germany.

    不過——除非我們花費大量資金在德國建造生物製劑工廠,否則它會進一步下降。

  • It's -- one of the key strategic moves that we're making for the coming years is to have our own large-scale biologics manufacturing.

    這是——我們在未來幾年內採取的關鍵戰略舉措之一是擁有我們自己的大規模生物製劑製造。

  • So absent that, we'll probably be more in the $500 million range, which you would see as more normal in the industry.

    因此,如果沒有這一點,我們可能會更多地處於 5 億美元的範圍內,你會認為這在行業中更為正常。

  • Operator

    Operator

  • Your next question comes from the line of Chris Schott of JPMorgan.

    您的下一個問題來自摩根大通的 Chris Schott。

  • Christopher Thomas Schott - Senior Analyst

    Christopher Thomas Schott - Senior Analyst

  • Just a couple of quick ones here.

    這裡只有幾個快速的。

  • First, maybe just coming back to the R&D spending.

    首先,也許只是回到研發支出。

  • Can we just get a sense of with the restructuring you're doing here, et cetera, how we should be thinking about absolute R&D spending as we think about 2018 and 2019?

    我們能否了解一下你們在這裡所做的重組,等等,在我們考慮 2018 年和 2019 年時,我們應該如何考慮絕對研發支出?

  • My second question was on the CGRP and sorry just coming back to this, but just to help set some of our expectations, when do you expect to have clarity on whether or not the FDA is going to allow this approval despite the warning letter?

    我的第二個問題是關於 CGRP 的,很抱歉剛剛回到這個問題,但只是為了幫助設定我們的一些期望,儘管有警告信,你希望什麼時候能明確 FDA 是否會允許這一批准?

  • Is this something which can wait for the PDUFA?

    這是可以等待PDUFA的嗎?

  • Or do you expect, based on some of this dialogue, you'll be able to update us ahead of that PDUFA date?

    或者您是否希望,根據其中的一些對話,您將能夠在 PDUFA 日期之前更新我們?

  • And then my final really quick question here was just on the timing of optimization.

    然後我最後一個非常快速的問題是關於優化的時間。

  • There is a 2018 top line guidance reflect much in the way of either product discontinuation and/or price increases on the generic portfolio?

    2018 年的頂線指導是否反映了仿製藥產品停產和/或價格上漲的方式?

  • Or should we really think about portfolio optimization as more of a 2019 event as we think of the top line impact?

    還是我們真的應該將投資組合優化更多地視為 2019 年的事件,就像我們認為對頂線的影響一樣?

  • Kåre Schultz - Former CEO & President

    Kåre Schultz - Former CEO & President

  • Thank you very much, Chris.

    非常感謝你,克里斯。

  • I'll do, I think, all 3 of them.

    我會做的,我想,所有三個。

  • So if you think about the R&D spending, then you could say we have taken a significant reduction on it as part of our restructuring plan.

    因此,如果您考慮研發支出,那麼您可以說我們已經大幅削減了研發支出,這是我們重組計劃的一部分。

  • And we will not be giving you the specific number, but you could say it's about or close to $1 billion that we expect going forward.

    我們不會給你具體的數字,但你可以說我們預計未來大約或接近 10 億美元。

  • And we don't expect that to be dramatically different between '18 and '19, maybe slightly less in '19 compared to '18.

    而且我們預計 18 年和 19 年之間不會有顯著差異,與 18 年相比,19 年可能會略有不同。

  • And with regards to the CGRP, then what exactly was that you wanted to know?

    關於 CGRP,你想知道的究竟是什麼?

  • Christopher Thomas Schott - Senior Analyst

    Christopher Thomas Schott - Senior Analyst

  • The question is just based -- would you expect to have clarity from FDA prior to your PDUFA based on your dialogues?

    這個問題只是基於——您是否希望根據您的對話在您的 PDUFA 之前獲得 FDA 的明確說明?

  • Or we really stand to wait for the PDUFA to see if this approach is going to be allowed?

    或者我們真的要等待 PDUFA 看看這種方法是否會被允許?

  • Kåre Schultz - Former CEO & President

    Kåre Schultz - Former CEO & President

  • I think, of course, we will know once we get to the PDUFA date.

    我想,當然,一旦我們到達 PDUFA 日期,我們就會知道。

  • But I think the most likely is that we will give you an update once we announce our first quarter results.

    但我認為最有可能的是,一旦我們公佈第一季度業績,我們就會給你一個更新。

  • This is not something where we will give you ongoing updates because you don't do that when you're in a dialogue with the FDA.

    這不是我們將為您提供持續更新的內容,因為您在與 FDA 對話時不會這樣做。

  • So I should expect that the next time you'll hear from us on this topic will be when we announce our first quarter results and when we have the color in that connection.

    所以我應該期待下一次你會聽到我們關於這個話題的消息,將是我們宣布我們的第一季度業績並且我們在這方面有顏色的時候。

  • With regard to the last question on the generics, then you could say both in '18 and '19, of course, we expect to see results of this process.

    關於泛型的最後一個問題,那麼您可以在 18 和 19 年都說,當然,我們希望看到這個過程的結果。

  • The results we expect in '18 are included in our outlook.

    我們對 18 年的預期結果包含在我們的展望中。

  • So -- but them -- very small in the sense that they have, of course, a slight negative effect on the revenue and a pretty much neutral to slightly positive effect on the earnings.

    所以——但它們——在某種意義上非常小,當然,它們對收入有輕微的負面影響,而對收益的影響幾乎是中性到輕微的積極影響。

  • Kevin C. Mannix - Head of Global IR & VP

    Kevin C. Mannix - Head of Global IR & VP

  • Well, thank you, everybody for joining us today.

    嗯,謝謝大家今天加入我們。

  • We'll be available throughout the rest of the week and next week to take any additional questions, and we look forward to seeing you all soon.

    我們將在本週剩餘時間和下週提供任何其他問題,我們期待很快與大家見面。

  • Thank you very much.

    非常感謝。

  • Operator

    Operator

  • Ladies and gentlemen, that does conclude our conference call today.

    女士們,先生們,今天的電話會議結束了。

  • For those of you wishing to review this conference, the replay facility can be accessed by dialing within the U.K. on (0845) 245-5205, or alternatively, on country code +44 1452 550000.

    對於那些希望回顧本次會議的人,可以通過在英國境內撥打 (0845) 245-5205 或國家代碼 +44 1452 550000 訪問重播設施。

  • The reservation number is 5279244 followed by the hash key.

    預留編號為 5279244,後跟散列鍵。

  • Thank you all for participating.

    謝謝大家的參與。

  • You may all disconnect.

    你們都可以斷開連接。