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Operator
Operator
Thank you for standing by, and welcome to the Teva report first-quarter 2015 financial results conference call.
感謝您的耐心等待,並歡迎參加 Teva 2015 年第一季度財務業績電話會議。
(Operator Instructions)
(操作員說明)
I must advise you that this conference is being recorded today, Thursday, the 30 of April, 2015.
我必須通知您,本次會議將於今天,即 2015 年 4 月 30 日,星期四進行錄製。
And I'd now like to turn the conference over to your first speaker today, Mr. Kevin Mannix, who's the Senior Vice President and Head of Investor Relations.
現在,我想將會議交給今天的第一位發言人凱文·曼尼克斯 (Kevin Mannix) 先生,他是高級副總裁兼投資者關係主管。
Please go ahead, sir.
請繼續,先生。
- SVP and Head of IR
- SVP and Head of IR
Thank you, Jenny.
謝謝你,珍妮。
Good morning and good afternoon, everyone.
大家早上好,下午好。
Thank you for joining us today to discuss Teva's first-quarter 2015 financial results.
感謝您今天加入我們討論 Teva 2015 年第一季度財務業績。
Our President and CEO, Erez Vigodman, and members of Teva's Executive Management team will present for approximately 20 minutes before opening the call up for questions and answers.
我們的總裁兼首席執行官埃雷茲·維戈曼 (Erez Vigodman) 和 Teva 執行管理團隊的成員將出席大約 20 分鐘,然後開始提問和回答。
A copy of the slides, as well as this morning's earnings press release, can be found on our website, tevapharm.com, under the Investor Relations section.
您可以在我們的網站 tevapharm.com 的投資者關係部分找到幻燈片的副本以及今天上午的收益新聞稿。
During this call, we will be making forward-looking statements, which are predictions, projections, or other statements about future events.
在這次電話會議中,我們將做出前瞻性陳述,即對未來事件的預測、預測或其他陳述。
These statements are based upon current expectations and assumptions that are subject to risks and uncertainties.
這些陳述基於當前的預期和假設,存在風險和不確定性。
Actual results could materially differ because of factors discussed in today's earnings press release and the comments made during this conference call and in the risk factors section of our Form 20-F, Form 6-K, and other reports and filings with the SEC commission.
由於今天的收益新聞稿中討論的因素以及本次電話會議期間以及我們的20-F 表、6-K 表以及向SEC 委員會提交的其他報告和文件的風險因素部分中發表的評論,實際結果可能會存在重大差異。
Discussions during the call will also include certain financial measures that were not prepared in accordance with generally accepted accounting principles.
電話會議期間的討論還將包括某些未按照公認會計原則制定的財務措施。
Reconciliations of those non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in this morning's press release and the back-up section of the slide presentation.
這些非公認會計原則財務指標與最直接可比的公認會計原則財務指標的調節可以在今天上午的新聞稿和幻燈片演示的備份部分中找到。
With that, I will now turn the call over to our CEO, Erez Vigodman.
現在,我將把電話轉給我們的首席執行官埃雷茲·維戈曼 (Erez Vigodman)。
Erez?
埃雷茲?
- President and CEO
- President and CEO
Thank you, Kevin.
謝謝你,凱文。
Good morning, and thank you for joining us today.
早上好,感謝您今天加入我們。
Before we get into the details of our first-quarter results, I want to briefly discuss the proposal we made to acquire Mylan for $82 per share in approximately 50% cash and 50% stock.
在詳細介紹第一季度業績之前,我想簡要討論一下我們提出的以每股 82 美元、約 50% 現金和 50% 股票收購 Mylan 的提議。
After speaking with many of you, [in closing doors], we're also Mylan stockholders.
在與你們中的許多人交談後,[閉門],我們也是邁蘭的股東。
We're confident that the combination of Teva and Mylan makes a strategic and financial sense, with our proposal representing full and fair price for Mylan and its stockholders.
我們相信 Teva 和 Mylan 的合併具有戰略和財務意義,我們的提案代表了 Mylan 及其股東的完整且公平的價格。
It remains our strong preference to [work] in collaboration with Mylan, and we are prepared to do so immediately.
我們仍然強烈傾向於與 Mylan 合作[工作],並且我們準備立即這樣做。
From all perspectives, this deal is compelling.
從各個角度來看,這筆交易都是引人注目的。
It makes sense for Teva, it make sense for Mylan, and it makes sense for both our respective stockholders, customers, patients and employees.
這對 Teva 有意義,對 Mylan 有意義,對我們各自的股東、客戶、患者和員工也有意義。
Accordingly, we're prepared to divulge all necessary resources to complete this combination.
因此,我們準備透露完成此次合併所需的所有資源。
As we have said before and will continue to say, we are committing to getting this done.
正如我們之前說過並將繼續說過的那樣,我們致力於完成這項工作。
With that, I'd like to ask you please limit your questions to our financial and operational results for the first quarter, as we do not intend to comment further about our proposal for Mylan.
因此,我想請您將問題限制在我們第一季度的財務和運營業績上,因為我們不打算進一步評論我們對 Mylan 的提案。
I thank you, all, in advance.
我提前感謝大家。
Q1 marks a strong start for the year.
第一季度標誌著今年的強勁開局。
And it continuous business momentum we saw over the course of 2014.
我們在 2014 年看到了持續的業務勢頭。
Revenues remain flat but increased 8% in local currencies.
收入保持不變,但以當地貨幣計算增長了 8%。
Operating income, net income, and EPS increased by 11% year-over-year.
營業收入、淨利潤和每股收益同比增長11%。
Cash flow from operations increased to $1.35 billion, 51% higher year-over-year.
運營現金流增加至 13.5 億美元,同比增長 51%。
And we generated free cash flow of $1.2 billion, 80% higher year-over-year.
我們產生了 12 億美元的自由現金流,同比增長 80%。
We're making progress all our key priorities for 2015.
我們在 2015 年的所有關鍵優先事項上都取得了進展。
We are on track to deliver $500 million in net cost savings.
我們有望實現 5 億美元的淨成本節省。
We are accelerating the strong business momentum of our generic business, improving its profitability and driving organic growth.
我們正在加速仿製藥業務的強勁業務勢頭,提高其盈利能力並推動有機增長。
We continue the transformation of our operational network, enhancing its competitiveness, and we are on track to reduce our [Everett] CPU by $10 by 2019, with 60% of the capacity placed in local locations, with Everett CPU of $6 or $7.
我們繼續對我們的運營網絡進行轉型,增強其競爭力,我們有望到2019 年將我們的[Everett] CPU 減少10 美元,其中60% 的容量放置在本地位置,Everett CPU 的價格為6 或7 美元。
We also continue to see significant achievement on the [quality reforms].
我們還繼續看到[質量改革]取得重大成就。
We are able to continue extending the life cycle of important product for us -- the conversion to Copaxone 40 milligram, the license to commercialize Eagle's rapid infusion product, the expansion of the Azilect franchise to markets outside the US.
我們能夠繼續延長重要產品的生命週期——轉換為 Copaxone 40 毫克、獲得 Eagle 快速輸注產品的商業化許可、將 Azilect 特許經營權擴展到美國以外的市場。
2015 is the year with more and more [offensive] orientation.
2015年是越來越[進攻]傾向的一年。
We have started to deliver on the [aforementioned] specialty pipeline.
我們已經開始交付[上述]專業管道。
With the FDA approval for ProAir RespiClick, the first and only breath activated dry powder rescue inhaler to be approved by the FDA for the treatment of acute asthma symptoms.
ProAir RespiClick 獲得 FDA 批准,這是第一個也是唯一一個獲得 FDA 批准用於治療急性哮喘症狀的呼吸激活干粉救援吸入器。
The submission of our [Reslizumab] is filed to the FDA.
我們的 [Reslizumab] 已向 FDA 提交。
The strong results in phase 2 of our chronic and episodic migraine program.
我們的慢性和陣發性偏頭痛項目第二階段取得了強勁成果。
The acquisition of Auspex, which is expected to close by the beginning of May and would enable us to claim for a leading position in the movement disorder space with unique platform that holds great promise across a wide spectrum of movement disorders that possess huge unmet needs, including Huntington's disease, Tardive Dyskinesia and Tourette syndrome.
對 Auspex 的收購預計將於 5 月初完成,這將使我們能夠憑藉獨特的平台在運動障礙領域佔據領先地位,該平台在具有巨大未滿足需求的廣泛運動障礙領域前景廣闊,包括亨廷頓病、遲發性運動障礙和抽動穢語綜合徵。
And of course, a potential large acquisition that we have recently announced.
當然,還有我們最近宣布的一項潛在的大型收購。
Now, Siggi, Mike, and Eyal will shed more light on our progress in generics, on how we plan to continue delivering on the promise of our pipeline, and on our Q1 financials.
現在,Siggi、Mike 和 Eyal 將更多地介紹我們在仿製藥方面的進展、我們計劃如何繼續兌現我們的產品線承諾以及我們第一季度的財務狀況。
- President and CEO of Global Generic Medicines Group
- President and CEO of Global Generic Medicines Group
Thank you, Erez.
謝謝你,埃雷茲。
We have done outstanding quarter for generics this first-quarter 2015.
2015 年第一季度,我們的仿製藥業務表現出色。
All of our regions shows the significant improvement over first-quarter 2014.
我們所有的地區都比 2014 年第一季度有了顯著改善。
And despite the FX impact, the profit for the generics increased 59% to $799 million.
儘管受到匯率影響,仿製藥的利潤仍增長了 59%,達到 7.99 億美元。
The revenues were up 9% to $2.6 billion.
收入增長 9%,達到 26 億美元。
And our operating profit in first-quarter was 30.5%, which is a significant improvement over the 2014 operating profit of 21.9% and 16.7% in operating profit in 2013.
我們第一季度的營業利潤為30.5%,比2014年的21.9%的營業利潤和2013年的16.7%的營業利潤有顯著改善。
We successfully launched generic Nexium, esomeprazole, on February 17.
我們於 2 月 17 日成功推出仿製藥 Nexium——埃索美拉唑。
We are still exclusive on the market.
我們在市場上仍然是獨家的。
But pending at the FDA are 10 other ANDA filers waiting for approval.
但還有其他 10 名 ANDA 申請者正在等待 FDA 的批准。
The international markets did very well.
國際市場表現非常好。
There was double-digit growth in the branded generics, for example, in Russia.
例如,在俄羅斯,品牌仿製藥出現了兩位數的增長。
And despite the FX impact we saw in that market.
儘管我們在該市場看到了外匯影響。
Europe had the record profitability levels.
歐洲的盈利水平創歷史新高。
The main reason there is we have a very good new product introduction.
主要原因是我們有很好的新產品介紹。
There is an improved pricing level in the European markets, and we have a much stronger supply chain on cost of goods than before.
歐洲市場的定價水平有所提高,我們的商品成本供應鏈也比以前更強大。
The strongest markets for us this time were Germany, UK, and Italy, that showed the record profitability levels.
這次對我們來說最強勁的市場是德國、英國和意大利,它們的盈利水平創下了歷史新高。
The OTC revenues were up 20% year-over-year in local currency.
以當地貨幣計算,OTC 收入同比增長 20%。
That is based on a very strong cough and cold season.
這是基於非常強烈的咳嗽和寒冷季節。
But the profitability of our joint venture with P&G improved significantly year-over-year.
但我們與寶潔合資公司的盈利能力同比顯著提高。
When we look at the -- [what the growth] and improvement in generics, we're continuing our improved operating profitability.
當我們關注仿製藥的[增長]和改進時,我們正在繼續提高運營盈利能力。
Our growth markets, our emerging markets, growth markets are significantly improving.
我們的成長型市場、我們的新興市場、成長型市場正在顯著改善。
We have a clear strategy for OTC going forward, and we are focusing more on our strong market.
我們對 OTC 的未來發展有明確的戰略,並且我們更加關注我們強大的市場。
And we showed that both in Europe, US and in the growth markets.
我們在歐洲、美國和成長型市場都證明了這一點。
We're looking at our cost of [up-sized] sales force effectiveness in our key markets.
我們正在研究關鍵市場中[擴大]銷售隊伍效率的成本。
It's very important to us.
這對我們來說非常重要。
So with that, I hand it over to Dr. Michael Hayden.
因此,我將其交給邁克爾·海登博士。
Michael?
邁克爾?
- President of Global R&D and Chief Scientific Officer
- President of Global R&D and Chief Scientific Officer
Good morning.
早上好。
Thank you, Siggi.
謝謝你,西吉。
I would like to just share with you some of the tremendous progress that's occurring and the depth in our Teva Specialty pipeline.
我想與您分享梯瓦特種產品線正在取得的一些巨大進展和深度。
As you can see, we have a total of 31 programs encompassing 134 clinical trials and more than 15,000 patients.
正如您所看到的,我們共有 31 個項目,涵蓋 134 項臨床試驗和超過 15,000 名患者。
These are focused in our major core therapeutic areas, with 16 in the CNS and pain and 9 (technical difficulty) [in respiratory].
這些重點關注我們的主要核心治療領域,其中 16 個涉及中樞神經系統和疼痛領域,9 個(技術難度)[呼吸領域]。
And this slide does include the Auspex programs, where we expect closure and the integration of Auspex in the very near future.
這張幻燈片確實包括了 Auspex 項目,我們預計 Auspex 項目將在不久的將來關閉和整合。
Next, what you can see is that at the summit and the outlook meeting at the end of 2014, we spoke about pivotal events in 2015.
接下來大家看到的是,在2014年底的峰會和展望會上,我們談到了2015年的關鍵事件。
And we are meeting all of the promise and delivering on the promise of our pipeline.
我們正在履行所有承諾並兌現我們管道的承諾。
As Erez spoke about, the RespiClick is now approved.
正如 Erez 所說,RespiClick 現已獲得批准。
Reslizumab has been submitted.
瑞利珠單抗已提交。
And importantly, our CGRP monoclonal antibody with now reported positive phase 2b results in both chronic and episodic migraine.
重要的是,我們的 CGRP 單克隆抗體現已報導 2b 期陽性,可導致慢性和陣發性偏頭痛。
We're the first anti CGRP compound to report positive data in chronic migraine.
我們是第一個報告慢性偏頭痛陽性數據的抗 CGRP 化合物。
Importantly, the particular two tester doses were positive on primary and secondary endpoints, which included the decrease in the number of hours and headache days at three months, relative to baseline.
重要的是,特定的兩個測試劑量在主要和次要終點上呈陽性,其中包括三個月時相對於基線的小時數和頭痛天數的減少。
These also showed separation from placebo at one month and decreased the consumption of other drugs used to treat migraine such as triptans different than Botox.
這些研究還表明,在一個月後就與安慰劑相分離,並減少了用於治療偏頭痛的其他藥物的消耗,例如與肉毒桿菌不同的曲坦類藥物。
The full data set will be presented from this study at the International Headache Society in Valencia in a few weeks.
這項研究的完整數據集將於幾週後在瓦倫西亞國際頭痛協會上公佈。
What is emerging, however, is that there are four companies with drugs in this particular space -- three [against] the ligand, one against the receptor.
然而,正在出現的情況是,有四家公司在這個特定領域提供藥物——三家針對配體,一家針對受體。
But these drugs are not all the same, and we would propose that the Teva compound has the potential to be the best in class.
但這些藥物並不完全相同,我們認為梯瓦化合物有可能成為同類藥物中最好的。
In our episodic migraine study, we also had two active doses tested.
在我們的偶發性偏頭痛研究中,我們還測試了兩種活性劑量。
The endpoints were met at three months relative to baseline.
相對於基線,三個月時達到了終點。
Importantly, both those were separated from placebo on primary and secondary endpoints at every endpoint.
重要的是,這兩種藥物在每個終點的主要和次要終點上都與安慰劑分開。
And both doses separated at one month for both endpoints.
兩個終點的兩個劑量間隔一個月。
There have been no safety concerns, and data from this study will be presented in great detail at the American Headache Society conference in Washington in June.
不存在任何安全問題,這項研究的數據將在六月於華盛頓舉行的美國頭痛協會會議上詳細介紹。
We're the first anti CGRP antagonist to show positive efficacy results in chronic and episodic migraines.
我們是第一個在慢性和陣發性偏頭痛中顯示出積極療效的抗 CGRP 拮抗劑。
The results from all of our competitors are now released in the abstracts that have just been released for the meeting in Valencia in May.
我們所有競爭對手的結果現已在五月份巴倫西亞會議剛剛發布的摘要中發布。
We've looked at four dosing paradigms across the two conditions, and all have been positive for primary and secondary endpoints and at one month of therapy.
我們研究了這兩種情況下的四種給藥方案,所有方案在主要和次要終點以及一個月的治療中均顯示出積極的結果。
And we're the only monoclonal antibody thus far reported that has separated from placebo across the entire duration of the study for primary and secondary endpoints.
我們是迄今為止報導的唯一一種在主要和次要終點研究期間與安慰劑分開的單克隆抗體。
Of course and importantly, no important safety concerns were identified.
當然,重要的是,沒有發現任何重要的安全問題。
What we're also excited about is the integration of Auspex into Teva, which we're expecting in the near future.
我們還對 Auspex 與 Teva 的整合感到興奮,我們預計這將在不久的將來實現。
Everything is on track.
一切都步入正軌。
The submission, the NDA for Huntington's disease, for SD-809, is pending and will occur in the near future.
SD-809 的亨廷頓病新藥申請 (NDA) 正在等待提交,並將在不久的將來提交。
This is an important drug that will complement the only approved drug in the United States for Huntington's disease.
這是一種重要的藥物,將補充美國唯一批准的治療亨廷頓病的藥物。
But of course, with this drug, because of the side effects and the heavy side effect profile, only 5% of patients are treated -- tremendous opportunity to use the drug for this indication.
但當然,由於這種藥物的副作用和嚴重的副作用,只有 5% 的患者得到了治療——這是使用該藥物治療這一適應症的巨大機會。
And we have received -- Auspex received FDA orphan designation.
我們已經獲得了——Auspex 獲得了 FDA 孤兒藥資格認定。
We're expected to launch in 2016.
我們預計將於 2016 年推出。
Also shortly, in the middle of this year, we expect the phase 2 results for Tardive Dyskinesia, a drug that will be useful in about 350,000 to 500,000 patients.
同樣不久,即今年年中,我們預計遲發性運動障礙的 2 期結果將公佈,該藥物將對約 350,000 至 500,000 名患者有用。
These are only the US numbers.
這些只是美國的數字。
And we will expect our results of phase 1b in Tourette syndrome, which would also have impact on 150,000 patients.
我們預計抽動穢語綜合症 1b 期的結果也會對 150,000 名患者產生影響。
There is no drug approved for Tardive Dyskinesia in the US, and there's only one drug approved for Tourette syndrome, with significant side effects.
在美國,還沒有批准用於治療遲發性運動障礙的藥物,並且只有一種藥物被批准用於治療抽動穢語綜合症,且具有顯著的副作用。
We see tremendous potential for SD-809 in these two other indications.
我們看到 SD-809 在這兩個其他適應症中的巨大潛力。
The reason we are particularly encouraged by SD-809 is its favorable side effect profile.
SD-809 讓我們特別受鼓舞的原因是它有利的副作用。
With twice daily dosing, you can see the frequency of adverse events is really no different from placebo.
每天兩次給藥,您可以看到不良事件的發生頻率與安慰劑沒有什麼不同。
And looking at a whole host of adverse events -- and this is very different from the current mode of therapy, tetrabenazine, where the side effect profile is the major limitation to therapy.
觀察一系列不良事件——這與目前的治療方式丁苯那嗪非常不同,其中副作用是治療的主要限制。
Overall, we have seen tremendous progress in our pipeline.
總體而言,我們在管道方面取得了巨大進展。
We're delivering on the results, as we told investors in 2014.
正如我們在 2014 年告訴投資者的那樣,我們正在兌現結果。
And with that, I'll hand over to Eyal Desheh.
接下來,我將把工作交給 Eyal Desheh。
- EVP and CFO
- EVP and CFO
Thank you very much, Michael.
非常感謝你,邁克爾。
Good morning, everyone.
大家,早安。
I'm pleased to review the financial results of this excellent quarter.
我很高興回顧這個出色的季度的財務業績。
As you can see, our revenues were practically unchanged in nominal terms.
正如您所看到的,我們的收入名義上幾乎沒有變化。
However, in real terms, this was percent -- 8% top-line growth.
然而,按實際價值計算,這是 8% 的收入增長。
Operating income, both at 11% nominal growth and 14% growth in real terms.
營業收入名義增長 11%,實際增長 14%。
11% growth in net income and earnings per share and 51% growth in cash flow from operations summarizes an excellent quarter.
淨利潤和每股收益增長 11%,運營現金流增長 51%,這是一個出色的季度。
Foreign exchange fluctuations, again, had negative impact of $368 million this time on revenues and $42 million on operating income.
外匯波動再次對收入產生了 3.68 億美元的負面影響,對營業收入產生了 4200 萬美元的負面影響。
The devaluation of the euro had the biggest impact on revenue, while the Russian ruble had a significant impact on our operating income.
歐元貶值對收入影響最大,而俄羅斯盧布對我們的營業收入影響較大。
Despite that, results were excellent.
儘管如此,結果還是很出色。
Cash flows continued to demonstrate strong year-over-year improvement, creating adequate resources for inorganic growth.
現金流繼續表現出強勁的同比改善,為無機增長創造了充足的資源。
This quarter, we delivered 51% increase in cash flow from operations and 80% increase in free cash flow, compared to Q1 in 2014.
與 2014 年第一季度相比,本季度我們的運營現金流增長了 51%,自由現金流增長了 80%。
Looking at the breakdown of our revenues by segments, the improvement in our generic business brought it to 52% of our total sales.
從我們按細分市場劃分的收入細分來看,我們的仿製藥業務的改善使其占總銷售額的 52%。
And even more so, when we looked at segment profits, the generic business contributed 44% of our operating profits before G&A, compared to 30% last year.
更重要的是,當我們考慮分部利潤時,非專利藥業務貢獻了我們不計一般及行政費用的營業利潤的 44%,而去年這一比例為 30%。
Lower sales of Copaxone, to which I will refer in a few slides, lower Copaxone [profit] contribution to 36% of the total, hence reducing the dependency on the product.
Copaxone 的銷量下降(我將在幾張幻燈片中提到),Copaxone [利潤] 的貢獻率降低至總利潤的 36%,從而減少了對該產品的依賴。
We are tracking the turn around in our generic business closely.
我們正在密切跟踪仿製藥業務的好轉情況。
As you heard from Siggi, this is doing very well.
正如您從 Siggi 那裡聽到的那樣,這一切做得非常好。
This quarter, gross margins reached nearly 50% for our generic business.
本季度,我們的仿製藥業務毛利率達到近 50%。
Segment profitability was 30.5%, above our plan for the year, which I have to remind you was 27%.
部門盈利率為 30.5%,高於我們今年的計劃,我必須提醒您的是 27%。
This is a 10 [point] percentage point improvement from last year, driven primarily by the launch of esomeprazole in the US and other new generic products.
這比去年提高了 10 個百分點,這主要是由於埃索美拉唑和其他新仿製藥在美國上市所致。
US market [increasing in prominence] is reflecting our strong focus on the US generic business.
美國市場[日益突出]反映出我們對美國仿製藥業務的強烈關注。
FX impact also had a contribution to that and other markets.
外匯影響也對該市場和其他市場產生了影響。
In total, that [will grow our] business in the United States to 59% of our total sales worldwide.
總的來說,這[將使我們]在美國的業務增長到我們全球總銷售額的 59%。
Quarterly revenues -- while revenues were flat year-over-year when compared to Q1 in 2014, the significant growth in generic, specialty, and OTC managed to offset FX impact.
季度收入——雖然與 2014 年第一季度相比,收入同比持平,但仿製藥、特種藥品和非處方藥的顯著增長成功抵消了匯率的影響。
The OTC piece, which we saw back to Proctor & Gamble and a reduction in sales of Copaxone.
OTC 部分,我們看到了寶潔公司和 Copaxone 銷量的減少。
In constant currency, sales were up, as mentioned, 8% year-over-year.
如前所述,按固定匯率計算,銷售額同比增長 8%。
Regarding Copaxone sales, the sales of Copaxone were down by approximately $200 million from Q4 2014.
關於Copaxone的銷售額,Copaxone的銷售額較2014年第四季度下降了約2億美元。
Half of this amount was due to not having a tender in Russia and the FX impact in Europe and in emerging markets.
其中一半是由於俄羅斯沒有進行招標以及歐洲和新興市場的外匯影響。
The decline in the US is due to inventory management in the channel.
美國的下滑是由於渠道的庫存管理造成的。
As you can see from the yellow line on this slide and TRx numbers, which are demonstrated here, demand for Copaxone family products remained very for strong.
從這張幻燈片上的黃線和此處展示的 TRx 數字可以看出,對 Copaxone 系列產品的需求仍然非常強勁。
Quarterly operating income -- so when we summarize the major movers of operating profits for the quarter, we see the improvement in generic, which was partially offset by the decline in Copaxone profits and the impact of foreign exchange.
季度營業收入——因此,當我們總結本季度營業利潤的主要推動因素時,我們看到仿製藥的改善,但部分被 Copaxone 利潤的下降和外彙的影響所抵消。
We continue to manage our liquidity very carefully.
我們繼續非常謹慎地管理我們的流動性。
In this quarter, we improve our bond rate structure by early termination of expensive US dollar bonds are replacing them by a cheaper euro bond offering.
在本季度,我們通過提前終止昂貴的美元債券並用更便宜的歐元債券發行取代它們來改善我們的債券利率結構。
This move will deliver net present value of $190 million over time.
隨著時間的推移,這一舉措將帶來 1.9 億美元的淨現值。
We currently have $3.8 billion in cash and other financial investments available to close the acquisition of Auspex, which is expected later this quarter.
目前,我們擁有 38 億美元的現金和其他金融投資,可用於完成對 Auspex 的收購,預計將於本季度晚些時候完成收購。
On our dividends, we keep our dividends, which as of this quarter, are denominated in US dollars at $0.34 per share.
關於股息,我們維持每股 0.34 美元的股息,截至本季度以美元計價。
Now, let's talk about our guidance.
現在,讓我們談談我們的指導。
Our original guidance for the year called for earnings per share of $5 to $5.30.
我們對今年的最初指導要求每股收益為 5 美元至 5.30 美元。
We know now that Copaxone generic introduction can technically happen between now and September.
我們現在知道 Copaxone 仿製藥的推出從技術上講可以在現在到 9 月之間進行。
In this guidance, we conservatively assume [an immediate launch].
在本指南中,我們保守地假設[立即啟動]。
So despite the negative FX impact and the anticipated introduction of generic Copaxone earlier than our general assumption, we increase our earnings per share guidance for the year to the range of $5.05 to $5.35.
因此,儘管匯率產生了負面影響,並且預計仿製藥 Copaxone 的推出早於我們的一般假設,但我們仍將今年的每股收益指導上調至 5.05 美元至 5.35 美元的範圍。
Thank you, all, for listing to our prepared remarks.
謝謝大家聽取我們準備好的發言。
And we will now open the call for questions.
我們現在開始提問。
Operator, please do.
接線員,請做。
Operator
Operator
(Operator Instructions)
(操作員說明)
Jason Gerberry, Leerink Partners.
Jason Gerberry,Leerink 合夥人。
- Analyst
- Analyst
First question, on the US Copaxone -- just curious if you guys, with what's happened with 20 milligrams, if you still stand behind the $5 eps US floor in 2017 if a 40 milligram generic comes to market?
第一個問題,關於美國 Copaxone——只是想知道,如果 40 毫克的仿製藥上市,20 毫克的仿製藥上市後,你們是否仍然支持 2017 年 5 美元每股收益的美國底價?
And then, my second question, for Dr. Hayden -- if you can comment on what you're expecting to disclose at HIS, regarding the CGRP program.
然後,我的第二個問題是問 Hayden 博士,您是否可以評論一下您希望在 HIS 披露的有關 CGRP 計劃的內容。
Thanks.
謝謝。
- President and CEO
- President and CEO
Michael, start with the second one.
邁克爾,從第二個開始。
- President of Global R&D and Chief Scientific Officer
- President of Global R&D and Chief Scientific Officer
Okay.
好的。
Thank you, Jason.
謝謝你,傑森。
Well for this particular meeting, where our abstract has been accepted for late-breaking session on chronic migraine, we will provide the exact results of the endpoints associated with this, the doses, the statistics associated with this, and show the data from one month to three months.
對於這次特別的會議,我們的摘要已被接受為慢性偏頭痛的最新會議,我們將提供與此相關的終點的確切結果、劑量、與此相關的統計數據,並顯示一個月的數據至三個月。
We will also talk about the absence of any safety concerns, and we will show this in great detail.
我們還將討論不存在任何安全問題,並且我們將詳細展示這一點。
We'll also be able to show the comparison although not (inaudible) -- no head-to-head comparison with other compounds.
我們還將能夠展示比較,儘管不能(聽不清)——沒有與其他化合物進行直接比較。
Of course, there is no other drug currently in the NC CGRP that has been shown to be used and has been used in chronic migraine.
當然,目前NC CGRP中還沒有其他藥物被證明可以使用並且已經用於治療慢性偏頭痛。
But we'll show, for comparison to the standard of care, the only approved drug for chronic migraine, which is Botox.
但為了與護理標准進行比較,我們將展示唯一批准治療慢性偏頭痛的藥物,即肉毒桿菌。
The results will be, I think, very convincing and compelling.
我認為,結果將非常有說服力和引人注目。
Thank you.
謝謝。
- President and CEO
- President and CEO
On the first one, we stick to the (inaudible) that we [shared with the street] in December, which means that we are -- [protect the] $5 per share EPS 2015, even now, also 2016.
關於第一個,我們堅持我們在 12 月[與街道分享]的(聽不清),這意味著我們 - [保護] 2015 年每股 5 美元的 EPS,即使是現在,也是 2016 年。
And from there, grow earnings 2017 and [excel us in the momentum], going forward.
以此為基礎,2017 年的盈利將會增長,並且[在勢頭上超越我們],繼續前進。
Operator
Operator
Randall Stanicky.
蘭德爾·斯坦尼基。
- Analyst
- Analyst
Can you talk about your strategy to protect the three times with the Copaxone in 2017, in light of the recent FDA update and generics?
根據最近 FDA 的更新和仿製藥,您能否談談您在 2017 年用 Copaxone 保護三倍的策略?
And perhaps, your strategy for the franchise, going forward?
也許,你的特許經營策略,未來會怎樣?
Thanks.
謝謝。
- President and CEO
- President and CEO
Yes.
是的。
Eyal, you start.
埃亞爾,你開始吧。
- EVP and CFO
- EVP and CFO
My pleasure.
我的榮幸。
Thanks for the question, Randall.
謝謝你的提問,蘭德爾。
What we see with Copaxone 40 is a huge enthusiasm, from patients and physicians alike, and a very big acceptance from payers.
我們對 Copaxone 40 看到了患者和醫生的巨大熱情,以及付款人的高度認可。
And in essence, we don't change our strategy.
從本質上講,我們不會改變我們的策略。
We see continued enthusiasm for this, with now over 20%, close to 21%, market share of Copaxone 40 in the US.
我們看到了對此的持續熱情,目前 Copaxone 40 在美國的市場份額超過 20%,接近 21%。
And we actually expect that the conversion, going forward, will be increasing, as indicated in earlier calls.
正如之前的電話會議所示,我們實際上預計未來的轉化率將會增加。
We continue to really support patients in getting access to the products and doctors getting access to the products.
我們繼續真正支持患者獲得產品和醫生獲得產品。
And the availability of a generic Copaxone 20, if and when that happens, is not going to significantly change that.
即使出現這種情況,通用 Copaxone 20 的上市也不會顯著改變這一點。
And we also expect very little switch back from the three times weekly to a generic product.
我們還預計很少有人會從每週三次轉回通用產品。
Outside of the US, we're launching Copaxone 40.
在美國境外,我們正在推出 Copaxone 40。
It's now on the marker in the most significant European countries like Germany, (inaudible), Netherlands, Denmark.
現在,它已在德國、(聽不清)、荷蘭、丹麥等最重要的歐洲國家出現。
And we continue to roll out our products in Europe and bring the same benefits that US patients have seen from the three times weekly, also, to the European and outside of Europe as well.
我們繼續在歐洲推出我們的產品,並為歐洲和歐洲以外的地區帶來與美國患者每週三次所看到的相同的好處。
So we continue our rollout of Copaxone 40 globally.
因此,我們繼續在全球推出 Copaxone 40。
- Analyst
- Analyst
Has -- thank you.
有——謝謝。
- President and CEO
- President and CEO
David?
大衛?
- General Counsel for Global Markets
- General Counsel for Global Markets
Hi, Randall.
嗨,蘭德爾。
It's David Stark, speaking.
說話的是大衛·史塔克。
Thanks for the question.
謝謝你的提問。
I think you were trying to touch on the patent case, as well.
我認為您也試圖觸及專利案件。
So we feel very good about our ability to defend our patents covering the 40 milligram product.
因此,我們對自己捍衛 40 毫克產品專利的能力感到非常滿意。
There's three main reasons for that confidence.
這種信心有三個主要原因。
First, the obviousness arguments raised in the IPR proceeding and the P4 case are not new.
首先,知識產權訴訟和 P4 案件中提出的顯而易見性論點並不新鮮。
The patent examiner had the same arguments in front of him and granted the patents.
專利審查員面前有同樣的論據並授予了專利。
Second, unlike for business method and technology patents, which are getting a lot of attention in the IPR context, very small changes to what is already in the public domain can lead to vastly different clinical results, as you know.
其次,與在知識產權領域受到廣泛關注的商業方法和技術專利不同,如您所知,對公共領域已有內容的微小改變可能會導致截然不同的臨床結果。
So it is very hard to prove predictability based on the prior art, especially for products like Copaxone, where the mechanism of action isn't entirely clear.
因此,基於現有技術很難證明可預測性,特別是對於像 Copaxone 這樣的產品,其作用機制尚不完全清楚。
So that is a pretty high bar.
所以這是一個相當高的標準。
Finally, our terrific track record at Teva in patent matters, generally.
最後,總的來說,我們在 Teva 在專利事務方面有著出色的記錄。
- President and CEO
- President and CEO
And then, just to add to that, something that -- I think it was manifested in the course of the -- where the patient (inaudible).
然後,補充一點,我認為它在患者(聽不清)的過程中表現出來。
We continue to deliver on the promise of our specialty pipeline and to bolster our specialty pipeline even further, the way we have done already in the course of the last 14 months.
我們將繼續兌現我們的專業產品線的承諾,並進一步加強我們的專業產品線,正如我們在過去 14 個月中所做的那樣。
In a quest to diversify our revenues away from Copaxone and basically to take the Company just away and beyond the Copaxone -- that's the purpose; that's the quest.
為了實現我們的收入多元化,遠離 Copaxone,基本上是讓公司超越 Copaxone——這就是我們的目的;這就是我們的追求。
And you'll see us delivering on that as we go along.
隨著我們的進展,您會看到我們正在實現這一目標。
- Analyst
- Analyst
David, can you help us with the timeline, though, on the litigation?
大衛,你能幫助我們了解訴訟的時間表嗎?
What should we think about for when we could get an update there?
當我們可以在那裡獲得更新時,我們應該考慮什麼?
Thanks.
謝謝。
- General Counsel for Global Markets
- General Counsel for Global Markets
Sure.
當然。
No problem.
沒問題。
In the IPR proceedings, there are two junctures.
在知識產權訴訟中,有兩個關鍵點。
One is a decision about whether to commence the proceeding or not.
一是決定是否啟動訴訟。
That is -- that will happen sometime in August of this year.
也就是說,這將在今年八月的某個時候發生。
And then, if there is a proceeding, that takes about a year.
然後,如果有訴訟程序,大約需要一年的時間。
Operator
Operator
Liav Abraham, Citi.
利亞夫·亞伯拉罕,花旗銀行。
- Analyst
- Analyst
A couple of additional questions on Copaxone.
關於 Copaxone 的幾個附加問題。
Can you comment on your view on the approvability of a Copaxone 40 milligram generic following the FDA's approval of the 20 milligram.
在 FDA 批准 20 毫克 Copaxone 40 毫克仿製藥後,您能否評論一下您對 Copaxone 40 毫克仿製藥批准性的看法?
Momenta is saying this is very doable, given that the products use the same API, so I'd be interested in your views, there.
Momenta 表示這是非常可行的,因為這些產品使用相同的 API,所以我對您的觀點很感興趣。
Then secondly, any additional commentary on your Copaxone biomarker program for the identification of high responders?
其次,對你們用於識別高反應者的 Copaxone 生物標誌物計劃還有什麼補充評論嗎?
Any updates there on where this stands and when we can expect this to reach patients?
關於這一情況的最新情況以及我們預計何時能夠到達患者手中有任何更新嗎?
- President and CEO
- President and CEO
Michael, please.
邁克爾,請。
- President of Global R&D and Chief Scientific Officer
- President of Global R&D and Chief Scientific Officer
Let me thank you, Liav.
讓我謝謝你,利亞夫。
Good morning.
早上好。
Just give you an update on the biomarker program.
只是向您提供生物標誌物計劃的最新情況。
We continue to do additional research into the validity and the predictability of the biomarker program.
我們繼續對生物標誌物計劃的有效性和可預測性進行更多研究。
We're now following patients up to three years.
我們現在正在對患者進行長達三年的跟踪。
And I'm delighted to see, which is quite unusual for some biomarkers, that this predictability is maintained over a three-year status, and it's highly robust.
我很高興看到這種可預測性能夠維持三年以上的狀態,而且非常穩健,這對於某些生物標誌物來說是很不尋常的。
So one's able to identify high responders with high specificity and also robust sensitivity.
因此,人們能夠識別具有高特異性和穩健敏感性的高反應者。
So we will be beginning pilot programs in Europe this year, in an effort to really look and translate this into patient care.
因此,我們今年將在歐洲開始試點項目,努力真正研究並將其轉化為患者護理。
We'll also would be extending some of the studies to the US by the end of the year.
我們還將在今年年底前將一些研究擴展到美國。
But we're delighted, which is often not the case for many biomarker studies, that with all the additional research we've done in different clinical trial sets of patients, the robustness of this particular biomarker to identify high responder patients is maintained.
但我們很高興(許多生物標誌物研究通常並非如此),通過我們在不同臨床試驗組患者中所做的所有額外研究,這種特定生物標誌物識別高反應患者的穩健性得以維持。
Also, to say that we have looked at purported generics to see whether in expression studies where they're actually having impact on the very genes involved.
另外,我們已經研究了所謂的仿製藥,以了解它們是否在表達研究中實際上對所涉及的基因產生了影響。
And in fact, the results are quite different, so the very genes that are altered by Copaxone are not altered by the purported generics.
事實上,結果完全不同,因此被 Copaxone 改變的基因並沒有被所謂的仿製藥改變。
So it is not likely and really would not be appropriate for these biomarker programs to be used for the purported generics that we've currently tested.
因此,這些生物標記程序不太可能也確實不適合用於我們目前測試的所謂仿製藥。
- SVP and Head of IR
- SVP and Head of IR
And Michael, I think there was also the question about the approvability of a 40 milligram generic.
邁克爾,我認為還有一個關於 40 毫克仿製藥的批准性的問題。
- President of Global R&D and Chief Scientific Officer
- President of Global R&D and Chief Scientific Officer
Yes.
是的。
Well, we do believe that just as with Copaxone 20, the 40 milligram also has, similar to 20, a very specific pattern of expression and shows a very significant differences to all the purported generics that we've seen.
好吧,我們確實相信,就像 Copaxone 20 一樣,40 毫克也具有與 20 類似的非常特殊的表達模式,並且與我們所見過的所有所謂的仿製藥顯示出非常顯著的差異。
So at this point, we maintain that the 40 milligram, three times a week, is really quite different to any of the purported generics we've seen.
因此,在這一點上,我們認為 40 毫克,每週 3 次,與我們見過的任何所謂的仿製藥確實有很大不同。
So we do not see -- we again see significant differentiation and, really, cannot comment on everyone because we, of course, have not had access to the Momenta product.
所以我們沒有看到——我們再次看到顯著的差異,而且實際上,我們不能對每個人發表評論,因為我們當然還沒有機會接觸到 Momenta 產品。
But as we get access to that, we will also be able to determine its sameness or differentiation as we do additional studies.
但當我們了解這一點時,我們也將能夠在進行更多研究時確定其相同性或差異性。
Operator
Operator
Louise Chen, Guggenheim.
路易絲陳,古根海姆。
- Analyst
- Analyst
My questions on the Auspex SD-809 product.
我對 Auspex SD-809 產品的疑問。
And I'm curious if you could comment more on the advantages of your product versus others that are in development, what you think of pricing -- because I know tetrabenazine's pricing may not be as high as what some people anticipate the Auspex product should be -- and then how it complements your Huntexil franchise and other drugs you might have in development for CNS.
我很好奇您是否可以更多地評論一下您的產品相對於其他正在開發的產品的優勢,以及您對定價的看法- 因為我知道丁苯那嗪的定價可能不會像一些人預期的Auspex 產品那樣高——然後它如何補充您的 Huntexil 特許經營權以及您可能正在開發的中樞神經系統藥物。
- President of Global R&D and Chief Scientific Officer
- President of Global R&D and Chief Scientific Officer
I will just take the first part, and then Rob will talk about the commercial aspects.
我只講第一部分,然後羅布將談論商業方面。
We believe this is a very important product in our Huntington's disease franchise.
我們相信這是我們亨廷頓舞蹈病系列中非常重要的產品。
Just to remind you, we're the leading Company in the world in this particular disorder.
只是提醒您,我們是這一特殊疾病領域的世界領先公司。
And that's not only important for Huntington's disease, but important, also, for other disorders which have shared biochemical pathways and shared pathways in causation, such as, for example, dementia, Alzheimer's disease, Parkinson's disease, and in fact, multiple sclerosis as well.
這不僅對亨廷頓氏舞蹈症很重要,而且對具有共同生化途徑和因果關係的其他疾病也很重要,例如癡呆症、阿爾茨海默病、帕金森病,事實上,多發性硬化症也是如此。
So what we're excited about with this SD-809 is particularly the side effect profile.
因此,我們對 SD-809 的副作用特別感興趣。
It is really quite remarkable, in that tetrabenazine has been approved in the United States.
丁苯那嗪已在美國獲得批准,這確實是非常了不起的。
And in fact, physicians and patients do not like the drug, despite the incapacitating movement disorder they have.
事實上,醫生和患者並不喜歡這種藥物,儘管他們患有導致喪失能力的運動障礙。
And they don't like it because, in fact, the drug predisposes to depression, one of the features of the disease, increased suicide, associated with somnolence in a very significant number of patients.
他們不喜歡它,因為事實上,這種藥物容易導致抑鬱症(該疾病的特徵之一),增加自殺率,並與相當多的患者嗜睡有關。
Also, this drug can cause Parkinson's disease, which can exacerbate the symptomatology of HD.
此外,這種藥物可能會導致帕金森病,從而加劇 HD 的症狀。
So the exciting development with SD-809 with [uteration] -- we understand the mechanism completely.
因此,SD-809 的令人興奮的發展與[言論]——我們完全理解了這個機制。
The side effects are due to the metabolites, and we know it that SD-809 has a much longer time.
副作用是由代謝物引起的,我們知道SD-809的作用時間要長得多。
It slows metabolism, in terms of generation of these particular metabolites.
就這些特定代謝物的產生而言,它會減慢新陳代謝。
And the side effect profile is really not differentiated from placebo.
而且副作用實際上與安慰劑沒有什麼區別。
This is a big advance.
這是一個很大的進步。
The physicians and neurologists involved in these patients all have voiced significant excitement about this particular product.
參與這些患者治療的醫生和神經科醫生都對這種特殊產品表示非常興奮。
The chorea is very significant on the impairment on the quality of life.
舞蹈病對生活質量的損害非常顯著。
So we've seen this tetrabenazine is the first of what is a spectrum of drugs that will be useful in patients, not only to treat symptomatically, but we have pridopidine behind it that we know has impact on movement disorder that is different and also has the potential to modify the course of the illness.
因此,我們已經看到丁苯那嗪是對患者有用的一系列藥物中的第一個,不僅可以對症治療,而且我們知道它背後有普利多匹定,我們知道它對運動障礙有不同的影響,而且還具有改變病程的潛力。
And (inaudible) behind that.
以及(聽不清)背後。
So we have, really, a profile of treatment.
所以我們確實有一個治療方案。
The disease, of course, in the United States -- 30,000 patients who are symptomatic, but about five times that number who carry the mutation and not get ill.
當然,這種疾病在美國有 30,000 名有症狀的患者,但攜帶突變但未患病的人數大約是這個數字的五倍。
So the total frequency of Huntington's disease is about half the number of patients with MS, with very little competition in the space, with only one approved drug.
因此,亨廷頓病的總發病率大約是多發性硬化症患者數量的一半,該領域的競爭很少,只有一種批准的藥物。
- President and CEO
- President and CEO
And maybe just to add to it something, (inaudible), we need to underscore the tetrabenazine today side effect profile is used by 5% only of the Huntington's patient population.
也許只是為了補充一些東西(聽不清),我們需要強調丁苯那嗪的副作用,目前只有 5% 的亨廷頓舞蹈症患者使用。
Which basically, for us, it means that there is a huge, unmet need there.
對於我們來說,這基本上意味著存在巨大的、未滿足的需求。
And basically, there is no real competition.
基本上,不存在真正的競爭。
- Analyst
- Analyst
What about the pricing?
定價怎麼樣?
Any thoughts there, or is it too early?
有什麼想法嗎,還是現在還太早?
- President and CEO of Global Specialty Medicines
- President and CEO of Global Specialty Medicines
Just to underscore what you're saying, Erez, it's a largely unmet need in largely untreated markets.
只是為了強調你所說的,埃雷茲,在很大程度上未經處理的市場中,這是一個很大程度上未得到滿足的需求。
We know, obviously, and you know the tetrabenazine price in this indication for years is about $85,000, which sets a mark in there.
顯然,我們知道,而且您也知道多年來該適應症中丁苯那嗪的價格約為 85,000 美元,這在該領域樹立了標杆。
But for us, it's too early to really discuss pricing.
但對我們來說,現在真正討論定價還為時過早。
Operator
Operator
Ronny Gal, Bernstein.
羅尼·加爾,伯恩斯坦。
- Analyst
- Analyst
Just a couple of them, very quickly.
只有幾個,很快。
If we look at your operating profit improvement year over year of $312 million, how much of that is due to the Nexium?
如果我們看看你們的營業利潤同比增長 3.12 億美元,其中有多少歸功於 Nexium?
That is, if we move Nexium, what will be the impact?
就是說如果我們搬Nexium,會有什麼影響?
What will be the impact of a generic business on operating income?
通用業務對營業收入有何影響?
A couple of quick, if I may jump.
如果我可以跳的話,快點。
If you can discuss Abilify for a second.
您可以討論一下 Abilify 嗎?
You just launched it yesterday.
您昨天剛剛啟動了它。
A big product -- not sure how limited the competition will be, early on.
一個大產品——不知道早期的競爭會有多有限。
And if I can step back and ask a broader question -- for the last five, six years, you've been talking about potential for growth of US for your generic business.
如果我可以退後一步,問一個更廣泛的問題——在過去的五六年裡,您一直在談論美國的仿製藥業務的增長潛力。
First in Europe, then in emerging markets, and it's in the (inaudible) partnership.
首先在歐洲,然後在新興市場,並且是(聽不清)合作夥伴關係。
And none of these have really generated a lot of constant currency year-over-year growth, as far as I can see.
據我所知,這些都沒有真正產生大量的貨幣同比增長。
Can you discuss, for a while, what you are changing about the growth -- about the way you run operations in those geographies to increase the rate of growth of the generic business?
您能否暫時討論一下您正在對增長做出哪些改變——關於您在這些地區運營業務以提高非專利業務增長率的方式?
- EVP and CFO
- EVP and CFO
Okay.
好的。
Maybe I will take the margin impact, and Siggi will take the rest of the question.
也許我會考慮利潤影響,西吉會考慮剩下的問題。
First of all, Nexium, of course, was in our plan, but we did not expect to be exclusive, so we had members in the plan already.
首先,Nexium當然在我們的計劃中,但我們並沒有期望它是排他性的,所以我們的計劃中已經有成員了。
The impact -- when we analyze what is the impact on the profitability of our generics, even without any of the Nexium sales, the profitability of the generic business is higher than last year.
影響——當我們分析對我們的仿製藥盈利能力的影響時,即使沒有任何耐信銷售,仿製藥業務的盈利能力也高於去年。
Very well on the way to achieve our targets and our guidance.
非常順利地實現我們的目標和指導。
All in all, it's a good, profitable product.
總而言之,這是一個很好的、有利可圖的產品。
But it's also shared with others, so we don't get all the profit from it.
但它也與其他人共享,因此我們並沒有從中獲得所有利潤。
And the next -- maybe Siggi can take it.
接下來——也許西吉可以接受。
- President and CEO of Global Generic Medicines Group
- President and CEO of Global Generic Medicines Group
Yes.
是的。
So Ronny, I think, overall, the improvement is in every region we're in.
所以羅尼,我認為,總的來說,我們所在的每個地區都有進步。
US, as Eyal just mentioned, esomeprazole was good, but the underlying business in the US has significantly improved year on year.
美國,正如Eyal剛才提到的,埃索美拉唑很好,但美國的基礎業務同比有明顯改善。
In Europe, it is the same.
在歐洲,情況也是一樣。
The growth markets -- even with the FX challenges we are seeing in the growth markets, we're seeing that.
成長型市場——即使我們在成長型市場中看到了外匯挑戰,我們也看到了這一點。
And even in Japan, we have managed to get to a double-digit operating profit from a single-digit last year.
即使在日本,我們的營業利潤也從去年的個位數實現了兩位數。
So we see a significant improvement.
所以我們看到了顯著的改進。
It's all about the execution.
一切都與執行有關。
We're basically executing better on the new launches.
基本上,我們在新產品的發布上表現得更好。
We are also are more focused.
我們也更加專注。
We're focusing on the bottom line, but also, as you can see, we grew our top line 9%.
我們專注於盈利,但正如您所看到的,我們的營收增長了 9%。
That is driven by new launches.
這是由新產品的推出推動的。
There's very little movement in volume on the established base business.
現有基礎業務的銷量變化很小。
That usually is quite constant, overall.
總體而言,這通常是相當恆定的。
But if I go to Abilify -- you started with that.
但如果我去阿比利菲——你就從那開始。
Yes, we launched that yesterday.
是的,我們昨天就推出了。
There are four players in the market for generic payers on the brand, but keep in mind, there's 18 filers, including Teva, on this product.
該品牌的通用付款人市場上有 4 個參與者,但請記住,該產品有 18 個申報人,其中包括梯瓦 (Teva)。
As I mentioned, 4 are already approved, 3 have tentative approval, and 11 don't have approval, as of yet.
正如我提到的,目前有 4 個已獲得批准,3 個已獲得臨時批准,11 個尚未獲得批准。
So this could change very quickly -- the situation -- but as it is now, we launched at risk into a four-player market.
因此,這種情況可能會很快發生變化,但就目前情況而言,我們冒著風險進入了一個四人市場。
- President and CEO
- President and CEO
(Multiple speakers).
(多個發言者)。
Only on the emerging market [stuff], and (inaudible).
僅針對新興市場[東西],並且(聽不清)。
You know we started and when we shared with you the full buckets of priorities for us.
您知道,當我們與您分享我們的全部優先事項時,我們就開始了。
(Inaudible).
(聽不清)。
We look at the emerging markets, and we [guide to] opportunities we will execute.
我們著眼於新興市場,並[指導]我們將執行的機會。
- Analyst
- Analyst
If I can push a little bit further, out of those $312 million in growth in generic, can you just dimension how big Nexium was?
如果我可以更進一步,在仿製藥 3.12 億美元的增長中,您能算出 Nexium 的規模有多大嗎?
Was it half of it?
是一半嗎?
Was it a quarter of it?
是四分之一嗎?
That is, if we just take it out, would you have growth from first-quarter 2014 to the first quarter of 2015?
也就是說,如果我們把它去掉的話,從2014年第一季度到2015年第一季度會有增長嗎?
- EVP and CFO
- EVP and CFO
Yes.
是的。
We would still have a significant growth.
我們仍然會有顯著的增長。
I can tell you that even if taking esomeprazole out, we would be growing our operating profit for over 400 basis points from first-quarter 2014 to first-quarter 2015.
我可以告訴你,即使去掉埃索美拉唑,從2014年第一季度到2015年第一季度我們的營業利潤也會增長400多個基點。
- President and CEO
- President and CEO
And again, Ronny, for you and the others, basically, we moved from [16.7%] operating profit 2013 to 21.9% at 2014.
Ronny,對於你和其他人來說,基本上,我們的營業利潤從 2013 年的 [16.7%] 上升到 2014 年的 21.9%。
And we basically call this to be generating 27% margin midpoint 2015.
我們基本上稱其為 2015 年中點利潤率 27%。
And we are well on track, well on track -- and without Nexium.
我們已經步入正軌,步入正軌——而且沒有耐信。
Operator
Operator
Andrew Finkelstein, Susquehanna.
安德魯·芬克爾斯坦,薩斯奎哈納。
- Analyst
- Analyst
Without going into the deal you proposed, could you speak more broadly about your analysis of the strategic environment in generics, both in the US and worldwide, particularly in the developed markets, in terms of the value of scale and the changes in the customer landscape that you're facing and, in particular, what that may mean for the pricing dynamics, regardless of whether you do a deal?
在不討論您提議的交易的情況下,您能否更廣泛地談談您對美國和全球仿製藥戰略環境的分析,特別是在發達市場,包括規模價值和客戶格局的變化您所面臨的問題,特別是無論您是否達成交易,這對定價動態可能意味著什麼?
- EVP and CFO
- EVP and CFO
Yes.
是的。
If we go through it in 2009 -- if we talk about our customers, in terms of volume, in the US, the top 3 customers in terms of volume were just over 50% in 2009.
如果我們回顧一下 2009 年——如果我們談論我們的客戶,就數量而言,在美國,2009 年,就數量而言前 3 位客戶的比例剛剛超過 50%。
When you look at 2014 in terms of value, they're approximately 80%.
如果你看看 2014 年的價值,你會發現它們大約是 80%。
So over five-years period, have grown from approximately 50% to 80%, in terms of volume.
因此,在五年期間,數量從大約 50% 增長到 80%。
The same, in the way, in Europe.
在歐洲也是如此。
The numbers are a little bit smaller.
數字有點小。
The top 3 customers in Europe were 50% in 2009, and they have grown to approximately 60% in 2014.
2009年歐洲前三大客戶的比例為50%,2014年已增長至60%左右。
At the same time, in the US, the top 4 generic companies in 2009 were 50% of the market.
與此同時,在美國,2009年排名前4位的仿製藥公司佔據了50%的市場份額。
They have declined to 40% of the market, simply because [their] smaller play taking more significant market share in the market.
他們的市場份額已經下降到 40%,僅僅是因為他們的規模較小,佔據了更大的市場份額。
So how we are looking at it -- it's important to be large in this.
所以我們如何看待它——在這方面做大很重要。
You're working with global customers.
您正在與全球客戶合作。
Teva today, I think, is well-positioned in working with the global customers that have businesses in the US but also all around the world.
我認為,今天的 Teva 在與在美國以及世界各地開展業務的全球客戶合作方面處於有利地位。
I think we have the largest scope of network to test them in the most locations, which is very critical when you work with them.
我認為我們擁有最大範圍的網絡來在大多數地點測試它們,這在您與他們合作時非常重要。
Our customers are looking for strong generic companies to work with that have a strong pipeline, a reliable supply, and a good quality.
我們的客戶正在尋找強大的仿製藥公司與之合作,這些公司擁有強大的管道、可靠的供應和良好的質量。
And we have all of that to offer.
我們可以提供這一切。
But clearly, in today's environment, with this significant consolidation of customers, it's important to be large to balance the business and grow with the big customers.
但顯然,在當今的環境下,隨著客戶的顯著整合,擴大規模以平衡業務並與大客戶一起成長非常重要。
- Analyst
- Analyst
Can you talk in any more detail about the investments you're making organically, in terms of complex generics and evolving the value of the pipeline in the US, in particular?
您能否更詳細地談談您正在進行的有機投資,特別是在復雜的仿製藥和不斷發展的美國管道價值方面?
- EVP and CFO
- EVP and CFO
Yes.
是的。
So this is our key growth strategy -- are the complex generics.
所以這是我們的關鍵增長戰略——複雜的仿製藥。
We really have a significant program.
我們確實有一個重要的計劃。
Probably more than about 50% of our products we're developing for the US today around complex generics.
目前,我們為美國開發的產品中,可能有超過 50% 是圍繞複雜的仿製藥開發的。
We are in the great position to do that, due to the synergies between our specialty development and generic development today.
由於我們今天的專業開發和仿製藥開發之間的協同作用,我們處於很好的位置來做到這一點。
Going forward, this will be a larger portion of our product that we launch to the market.
展望未來,這將是我們向市場推出的產品的很大一部分。
You will start to see that already in 2016 and then 2017 and onward.
你將在 2016 年、2017 年及以後開始看到這一點。
And this is a key part of our growth in the generic business which we're talking about to compensate for any loss of exclusivity on the specialty products.
這是我們通用業務增長的關鍵部分,我們正在談論通用業務,以彌補特種產品排他性的任何損失。
- President of Global R&D and Chief Scientific Officer
- President of Global R&D and Chief Scientific Officer
And I wonder if I may just add something.
我想知道我是否可以添加一些內容。
Of course, in the complex generics, we also have unique opportunities from the integration of R&D to add significant capabilities to the development.
當然,在復雜的仿製藥中,我們也有獨特的機會通過研發整合來為開發添加重要的能力。
One of the examples is in respi, where one is able to use the experience clinically from our specialty area in respi, have the appropriate formulation, have a device -- all of this representing a tremendous integration with multiple programs under development (inaudible) and really leveraging the specialty expertise, together with outstanding expertise in complex generics, and putting this all together to create comparative capabilities.
其中一個例子是 respi,人們能夠利用我們在 respi 專業領域的臨床經驗,擁有適當的配方,擁有一台設備——所有這些都代表著與正在開發的多個項目的巨大集成(聽不清)和真正利用專業知識以及復雜仿製藥方面的傑出專業知識,並將所有這些結合在一起以創建比較能力。
Operator
Operator
Ken Cacciatore, Cowen and Company.
肯·卡恰托雷 (Ken Cacciatore),考恩公司。
- Analyst
- Analyst
Just wanted to add to ask -- can you, from a financial perspective, and do you want to, from a strategic perspective, continue to pursue branded products or portfolios or commercial or development assets while you're going through this process with Mylan?
只是想補充一點——在與邁蘭一起經歷這一過程的同時,您能否從財務角度以及從戰略角度繼續追求品牌產品或投資組合或商業或開發資產?
- President and CEO
- President and CEO
The answer is absolutely, yes.
答案是絕對的,是的。
Operator
Operator
David Maris, BMO.
大衛·馬里斯,BMO。
- Analyst
- Analyst
Couple questions.
幾個問題。
On Copaxone 40 milligram, you said you feel good about the patent position, about the pipeline offsetting any of the riskier.
關於 Copaxone 40 毫克,您說您對專利地位以及抵消任何風險較高的管道感到滿意。
And you're happy with the conversion so far.
到目前為止,您對轉換感到滿意。
My question is really simple.
我的問題很簡單。
In your modeling, what year are you assuming that Copaxone 40 milligram goes generic?
在您的模型中,您假設 Copaxone 40 毫克成為通用名藥是在哪一年?
And then separately, Siggi, I met with a top 10 generic company recently that said that mega mergers in the generic space are anticompetitive and bad for consumer pricing.
另外,Siggi,我最近會見了一家排名前 10 位的仿製藥公司,該公司表示仿製藥領域的大型合併是反競爭的,並且不利於消費者定價。
And part of it is driven as a response to wholesaler and retailer consolidation, which you just mentioned in the previous question.
其中一部分是為了應對批發商和零售商的整合,正如您在上一個問題中提到的那樣。
So do you think if, for example, Sandoz and Actaviz or any other top few generic companies were to merge, would you think that they have better negotiating power with price, with buyers, or do you think that would be negative?
那麼,您是否認為,例如,如果山德士和阿特維茲或任何其他幾家頂級仿製藥公司合併,您是否認為他們在價格、與買家方面擁有更好的談判能力,或者您認為這會是負面的?
- President and CEO
- President and CEO
Thank you, David, for the questions.
謝謝大衛提出的問題。
On the first one, we have a clear and a (inaudible) again.
對於第一個,我們有一個清晰的和一個(聽不清)的。
When we discuss with the Street in December the -- basically -- the four levers of growth framework, what we have basically presented is a decline for our existing franchise portfolio, including Copaxone, from 2013, 2014, onward.
當我們在 12 月與華爾街討論——基本上——增長框架的四個槓桿時,我們基本上提出的是我們現有的特許經營產品組合(包括 Copaxone)從 2013 年、2014 年開始的下降。
And in a way which is compensated by new launches of our specialty products coming from the pipeline.
在某種程度上,我們通過新推出的特色產品來彌補這一不足。
And of course, from then, inorganic moves that [will enable] us to bolster further the pipeline.
當然,從那時起,無機舉措將使我們能夠進一步加強管道。
And we're very [solidly] sticking to the plan that was presented to the market.
我們非常[堅定地]堅持向市場提出的計劃。
Siggi?
西吉?
- President and CEO of Global Generic Medicines Group
- President and CEO of Global Generic Medicines Group
Yes.
是的。
So David, I think, first of all, there is still a significant pricing pressure on the market, due to the consolidation of the customers.
所以大衛,我認為,首先,由於客戶的整合,市場上仍然存在很大的定價壓力。
I just mentioned a minute ago that the top 3 customers are 80%, while the top 4 generic companies are approximately 40% of the US markets.
我剛才提到,前 3 名客戶占美國市場的 80%,而前 4 名仿製藥公司約占美國市場的 40%。
So there's no question about it -- the pricing pressure comes very strongly from the large customers.
所以毫無疑問——定價壓力來自大客戶。
No matter if you are big or large, there is no question about it.
不管你是大還是大,這都是沒有問題的。
The big benefit is basically to have a global reach a being able to offer a full range of portfolio.
最大的好處基本上是擁有全球影響力,能夠提供全方位的產品組合。
Full range of portfolio, large [ANDA], enough new supply to come to the market, touch the customers in every market they're operating.
全系列的產品組合、大量的[ANDA]、足夠的新供應進入市場,接觸到他們所經營的每個市場的客戶。
Is the pricing pressure going to be more or less if you are big or large?
你規模大還是規模大,定價壓力會更大還是更小?
You have to keep in mind, David, that there's hundreds of companies offering generics in the US today.
大衛,你必須記住,當今美國有數百家公司提供仿製藥。
And those customers are very smart.
這些客戶非常聰明。
They look for three things -- they look for quality, they look for reliability of supply, and they look for price.
他們注重三件事——質量、供應的可靠性以及價格。
And clearly, they look for price -- there is no question about it.
顯然,他們看重的是價格——這是毫無疑問的。
Yes, there might be, I think, overall, what we offer to the customer -- what that large generic company could offer to the customer is a broader portfolio, more new launches, better supply chain, and hopefully better cost of goods.
是的,我認為,總體而言,我們向客戶提供的可能是——大型仿製藥公司可以向客戶提供的是更廣泛的產品組合、更多新產品的推出、更好的供應鏈,以及希望更好的商品成本。
The pricing pressure -- I really don't know.
定價壓力——我真的不知道。
I really don't know, due to the simple things that there's so many companies today offering generics in the US market.
我真的不知道,因為很簡單,今天有很多公司在美國市場上提供仿製藥。
- Analyst
- Analyst
I guess a different way asking -- do you think that if two of your large peers came together, would they expect that their pricing power would be slightly better or slightly worse?
我想換個方式問——你認為如果你的兩個大同行走到一起,他們會期望他們的定價能力會稍微好一點還是稍微差一點嗎?
- President and CEO of Global Generic Medicines Group
- President and CEO of Global Generic Medicines Group
I can't speak for my competitors.
我不能為我的競爭對手說話。
Very difficult to estimate what my -- I don't think it's worse or better.
很難估計我的情況——我不認為情況更糟或更好。
I think the opportunity is basically for a greater business because you have a stronger company, stronger pipeline, stronger offering, better supply chain, better cost of goods.
我認為機會基本上是為了更大的業務,因為你擁有更強大的公司、更強大的管道、更強大的產品、更好的供應鏈、更好的商品成本。
And that is why you can improve your business.
這就是為什麼您可以改善您的業務。
I'm not sure if I can even comment on the pricing environment of a bigger company.
我不確定我是否可以對大公司的定價環境發表評論。
- President and CEO
- President and CEO
I think, David, that to look at the potential combination of two of our competitors, to look at something that might go beyond just the way they are able to encounter potential pricing pressure.
大衛,我認為,要看看我們兩個競爭對手的潛在組合,看看可能超出他們能夠遇到潛在定價壓力的方式的東西。
Yes, of course, the consolidation that we witness that the customers landscape is one of the drivers for the consolidation that we have been witnessing in our space.
是的,當然,我們見證的客戶環境的整合是我們在我們的領域見證的整合的驅動因素之一。
But at the same time, we see duplication.
但與此同時,我們也看到了重複現象。
We see the over-capacity; we see the inefficiencies.
我們看到產能過剩;我們看到了效率低下的情況。
Everybody's doing the same, basically, and we are on the global scale.
基本上每個人都在做同樣的事情,而且我們是在全球範圍內。
And the quest to be able to [extract] the benefits from such a combination enables me to not just to compete better on prices or not just to be able to (inaudible), but also to invest the resources -- (inaudible) -- in the new frontier of complex generic, complex technologies, and biosimilars and to build a platform which is equipped to deal with basically the requirements of the new frontier.
尋求能夠從這種組合中獲取利益,使我不僅能夠在價格上更好地競爭,或者不僅僅是能夠(聽不清),而且還能投資資源——(聽不清)——在復雜仿製藥、複雜技術和生物仿製藥的新領域,並建立一個基本上能夠滿足新領域要求的平台。
- Analyst
- Analyst
So let me -- let me just tell you the genesis of the question, because then maybe it will help you.
所以讓我——讓我告訴你這個問題的起源,因為這樣也許會對你有所幫助。
[Because else, I've] gotten half-dozen emails saying -- Why are you asking an FCC question?
[因為否則,我]收到了六封電子郵件,內容是——你為什麼要問 FCC 問題?
I'm really asking -- when we were talking with this other company about when two companies come together and they have some overlap, and one sells -- but small market share.
我真的想問——當我們與另一家公司討論兩家公司合併時,它們有一些重疊,其中一家出售——但市場份額很小。
And one sells for a product for $0.10, and the other says it for $0.13.
其中一個產品的售價為 0.10 美元,另一個則說產品售價為 0.13 美元。
If I was CVS or a Cardinal, wouldn't I just say -- Great.
如果我是 CVS 或紅衣主教,我不會只是說——太好了。
I'm looking at your portfolio; I want the lower price for each?
我正在看你的投資組合;我想要每件都更低的價格?
So they'd say -- no, there's actually -- you get a little bit of -- having a broader portfolio is a strategic advantage because you can then push back a little bit more on pricing.
所以他們會說——不,實際上——你會得到一點——擁有更廣泛的投資組合是一種戰略優勢,因為你可以在定價上稍微推遲一點。
So that's really the genesis of whether or not, when you come together, are there sales synergies or sales dis-synergies?
因此,這確實是當你們聚集在一起時是否存在銷售協同效應或銷售反協同效應的根源?
- President and CEO
- President and CEO
Yes.
是的。
I know what you're coming from.
我知道你來自何方。
Really, our customers are more sophisticated than your question gives away.
確實,我們的客戶比您的問題所透露的更複雜。
They have a very sophisticated buying offices in Bern, in London, and in Rhode Island, of looking to get all of the things I mentioned before.
他們在伯爾尼、倫敦和羅德島設有非常複雜的採購辦公室,希望獲得我之前提到的所有東西。
They clearly look for a good price all the time, but they're looking for reliability and the high quality.
顯然,他們一直在尋找好的價格,但他們也在尋找可靠性和高品質。
And I think we can do that, going forward.
我認為我們可以做到這一點,繼續前進。
I don't think in the concept of your question is applicable here.
我認為你的問題的概念在這裡不適用。
Operator
Operator
Sumant Kulkami, Bank of America Merrill Lynch.
Sumant Kulkami,美銀美林。
- Analyst
- Analyst
I have three quick ones.
我有三個快的。
First, for Siggi -- how much more potential exists to increase generic segment margins purely from organic gains in operational efficiency?
首先,對於 Siggi 來說,純粹通過運營效率的有機收益來提高通用細分市場的利潤率還有多少潛力?
Second one is, what is the potential for cost containment on the selling and marketing infrastructure on the MS part of the specialty segment?
第二個問題是,專業領域的 MS 部分的銷售和營銷基礎設施的成本控制潛力有多大?
And third, how is Teva thinking about generic competition to the Copaxone franchise in other important ex-US markets?
第三,Teva 如何考慮 Copaxone 特許經營權在美國以外其他重要市場的仿製藥競爭?
- President and CEO of Global Generic Medicines Group
- President and CEO of Global Generic Medicines Group
Sumant, thanks for this.
蘇曼特,謝謝你。
I think, overall, we proved that very aggressive goal of 27% midpoint.
我認為,總體而言,我們證明了 27% 中點這一非常激進的目標。
Basically, we gave our forecast was 26% to 28% operating profit in the generics segment, which would be approximately 1,000 basis points improvement over a two-year period.
基本上,我們的預測是仿製藥領域的營業利潤為 26% 至 28%,這將在兩年內提高約 1,000 個基點。
I think there is room for more, but it takes a little longer time.
我認為還有更多空間,但需要更長的時間。
What plays into the operating profit in the generics are probably three or four things.
影響仿製藥營業利潤的因素可能有三到四點。
First of all, we have a significant improvement in our cost of goods.
首先,我們的商品成本有了顯著改善。
I think the operation team in Teva has done an outstanding job in lowering the cost of goods, improving the quality of the supply.
我認為梯瓦的運營團隊在降低商品成本、提高供應質量方面做得非常出色。
And really, it's my business that has benefited from that, because a big portion of our volume comes straight to the generic business.
事實上,我的業務從中受益,因為我們的業務量的很大一部分直接來自通用業務。
And really, we will continue that over time.
事實上,隨著時間的推移,我們將繼續這樣做。
As Erez mentioned earlier, we have a goal to get to $10 per 1,000 -- conversion cost per 1,000 tablets by 2019, with 60% of our volume at $7 or lower.
正如 Erez 之前提到的,我們的目標是到 2019 年達到每 1,000 片 10 美元——每 1,000 片平板電腦的轉換成本,其中 60% 的銷量為 7 美元或更低。
I think the next thing is the portfolio offering.
我認為接下來要做的是投資組合產品。
I think the more we have of exclusive complex generics on offering, we have a higher margin on these products.
我認為我們提供的獨家複雜仿製藥越多,我們在這些產品上的利潤就越高。
It's simple.
這很簡單。
So when we have more of the launches, it will drive up the margin.
因此,當我們推出更多產品時,就會提高利潤率。
The third thing is the cost infrastructure.
第三件事是基礎設施的成本。
I think we have done a very good job in the cost infrastructure.
我認為我們在成本基礎設施方面做得非常好。
You can see that from our gross margin versus our operating profits.
您可以從我們的毛利率與營業利潤中看到這一點。
There is improvement in the operating profit over and above the gross margin, so that is our cost infrastructure, which we will continue to work on the extent.
營業利潤的改善超過了毛利率,這就是我們的成本基礎設施,我們將繼續在一定程度上努力。
And then the fourth thing is, where our key focus areas?
第四件事是,我們的重點關注領域在哪裡?
So with all of these four things, I think we can probably improve from this year by maybe 100 to 150 basis points, going forward.
因此,有了這四件事,我認為我們可能會比今年提高 100 到 150 個基點,繼續前進。
But obviously, the big jumps of 1,000 basis points we have taken over the last 24 months -- you wouldn't see that skill of improvement in the generics.
但顯然,我們在過去 24 個月裡實現了 1,000 個基點的大幅躍升 - 你不會在仿製藥中看到這種改進技巧。
But I think at the end of this year, we are in world-class level, in terms of profitability of generics.
但我認為,到今年年底,就彷製藥的盈利能力而言,我們處於世界一流水平。
When you look at the top line growth, you see that already in first-quarter, we have improved our top-line growth.
當您查看營收增長時,您會發現我們在第一季度就已經改善了營收增長。
That mainly comes from our new launches but also our emphasis on the branded generic markets.
這主要來自我們的新產品發布,但也來自我們對品牌仿製藥市場的重視。
So in the branded generic markets, we have seen the top line growth because we're investing more in the infrastructure there.
因此,在品牌仿製藥市場,我們看到了營收增長,因為我們在那裡的基礎設施上投入了更多資金。
And we will continue to see that, going forward, because you, at some point in time, cannot get more operating profit for being leaner and meaner inside the business.
我們將繼續看到這一點,因為在某個時間點,你無法因為業務內部更加精簡和精簡而獲得更多營業利潤。
- President and CEO
- President and CEO
On the (multiple speakers) ex-US 40 milligram competition, Eyal, please.
關於(多名發言者)前美國 40 毫克比賽,請 Eyal 發言。
- EVP and CFO
- EVP and CFO
So first of all, thanks, Sumant, for the question.
首先,謝謝 Sumant 提出的問題。
So we're rolling out our Copaxone 40 in Europe as we speak.
因此,我們正在歐洲推出 Copaxone 40。
As I said before and indicated, it's on the market in Denmark, in the Netherlands, and Germany, and Israel.
正如我之前所說並指出的,它在丹麥、荷蘭、德國和以色列市場上都有銷售。
And we're rolling out in other countries there.
我們正在那裡的其他國家推廣。
And this is an important part of defending and improving our Copaxone franchise.
這是捍衛和改善我們 Copaxone 特許經營權的重要組成部分。
In terms of generic competition in Europe, the authorities have made it very clear that they require evidence -- clinical evidence -- for safety and efficacy.
就歐洲的仿製藥競爭而言,當局已經非常明確地表示,他們需要證據——臨床證據——來保證安全性和有效性。
And as far as we can judge, first of all, this has not changed.
而據我們判斷,首先,這一點沒有改變。
And second, there is nothing really near that would provide this.
其次,沒有任何東西可以真正提供這一點。
So this is -- we continue to really do that and launch our Copaxone 40 as good as we possibly can.
所以,我們將繼續真正做到這一點,並儘可能推出我們的 Copaxone 40。
In terms of your question on managing the costs of it, well first of all, the percentage of expense on Copaxone was never really very high.
就您關於管理成本的問題而言,首先,Copaxone 的費用百分比從來都不是很高。
We obviously invested in the US for the Copaxone 40 launch and continue to support it as good as we can.
顯然,我們在美國投資了 Copaxone 40 的上市,並繼續盡我們所能地支持它。
And everything that is needed will be done there to continue to be as successful as we are.
所需的一切都將在那裡完成,以繼續像我們一樣取得成功。
Then, the same CNS team is actually there, also, to help them prepare the launch and do the launch after for the Auspex products and our pain franchise in there.
然後,同一個 CNS 團隊實際上也在那裡,幫助他們準備發布並在之後發布 Auspex 產品和我們的疼痛專營權。
So the people there really are focusing, also, largely on what Erez already stressed a couple of times -- making our launches successful and drive our future beyond Copaxone.
因此,那裡的人們確實主要關注埃雷茲已經強調過幾次的事情——使我們的產品發布成功並推動我們的未來超越 Copaxone。
- President and CEO
- President and CEO
And maybe that's a point to indicate -- that Teva plans to see $4.5 billion of new net revenues by 2019 from launches of specialty products from 2014.
也許這就是一個要點——Teva 計劃從 2014 年開始推出特色產品,到 2019 年實現 45 億美元的新淨收入。
So basically -- and after we narrow the focus, [to areas] where we add strength -- where we have established strength -- and we're in a position to claim for a market leadership, we see the importance of our proximity to patients and the services that we'll render to patients as an important lever in the equation.
因此,基本上,在我們將重點縮小到我們增加實力的領域(我們已經建立了實力的領域)並且我們有能力獲得市場領導地位之後,我們看到了我們接近的重要性患者和我們將為患者提供的服務是其中的重要槓桿。
It is -- it will not be confined just to MS patients.
它不僅限於多發性硬化症患者。
Of course, [there is] today a strong focus on MS patients, and we'll continue to put strong focus on MS patients.
當然,今天人們非常關注多發性硬化症患者,我們將繼續高度關注多發性硬化症患者。
But to go along with, basically, other indications and solutions that we'll be providing, we are using more of the arm that was developed and even will extend it even further, in order to capitalize on the benefits from patient proximity, from patient intervention, from services rendered to patients, in a way which would cause the entire spectrum of solutions that we have been offering.
但基本上,為了配合我們將提供的其他適應症和解決方案,我們正在使用更多已開發的手臂,甚至會進一步擴展它,以便利用患者接近、患者的好處。干預,從向患者提供的服務,這將導致我們一直提供的整個解決方案。
- President and CEO of Global Generic Medicines Group
- President and CEO of Global Generic Medicines Group
And just to add what Erez has said, of course, to be very specific, we're launching that for migraine -- migraine solutions -- in the very near future.
當然,要補充一下埃雷茲所說的非常具體的內容,我們將在不久的將來推出針對偏頭痛的偏頭痛解決方案。
We're also developing programs for Huntington's, for Huntington's disease solutions.
我們還在開發針對亨廷頓舞蹈症的項目,針對亨廷頓舞蹈病的解決方案。
All leveraging the expertise and benefit of what we learned from shared solution.
所有這些都利用了我們從共享解決方案中學到的專業知識和優勢。
And also, in the long-term and medium-term, really looking at this as a global patient support service.
而且,從長期和中期來看,真正將其視為全球患者支持服務。
Operator
Operator
Gregg Gilbert, Deutsche Bank.
格雷格·吉爾伯特,德意志銀行。
- Analyst
- Analyst
First, when Sandoz launches the generic Copaxone 20, do you have a plan to launch an AG?
首先,當山德士推出仿製藥Copaxone 20時,你們有計劃推出AG嗎?
Or will you wait to see share dynamics play out first?
或者您會先等待股票動態發揮作用嗎?
Secondly, Michael, on the CGRP, have you had your FDA meeting yet, or is it at least set up, to discuss the phase 3 plans?
其次,Michael,關於 CGRP,您是否已召開 FDA 會議,或者至少已經召開會議來討論第 3 階段計劃?
And you see a path for some sort of expedited plan, given the unmet need and the efficacy, compared to the standard of care?
考慮到未滿足的需求和功效,與護理標準相比,您是否看到了某種加急計劃的途徑?
Lastly, for Erez, are you committed to maintaining a significant dividend and growing the dividend, regardless of what deals you do, going forward?
最後,對於埃雷茲來說,無論您未來進行什麼交易,您是否都致力於維持可觀的股息並增加股息?
- President and CEO
- President and CEO
Rob, please.
羅布,請。
- President and CEO of Global Specialty Medicines
- President and CEO of Global Specialty Medicines
Thanks, Gregg.
謝謝,格雷格。
We continue to really monitor the entrance of a generic and, obviously, also the penetration of Copaxone 40, as we continue to be very careful on that.
我們繼續真正監控仿製藥的進入,顯然,還有 Copaxone 40 的滲透,因為我們對此仍然非常小心。
And keep the best interest of patients at heart and keep every single option open that serves just that purpose.
始終將患者的最大利益放在心上,並保留每一個旨在實現這一目的的選擇。
- Analyst
- Analyst
Sorry, Rob.
對不起,羅布。
My question was on the 20 milligram generic.
我的問題是關於 20 毫克仿製藥。
- President and CEO of Global Specialty Medicines
- President and CEO of Global Specialty Medicines
And my answer was on the 20 milligram, as well.
我的答案也是 20 毫克。
- Analyst
- Analyst
Okay.
好的。
- President and CEO of Global Specialty Medicines
- President and CEO of Global Specialty Medicines
We keep monitoring very carefully and keep every option open.
我們一直非常仔細地監控並保留每個選項。
But the conversion to 40 is an important element in that monitoring.
但轉換為 40 是該監控中的一個重要元素。
- President of Global R&D and Chief Scientific Officer
- President of Global R&D and Chief Scientific Officer
And just to comment on the CGRP -- of course, now with the results, we had waited for both the results for chronic and episodic and look forward to our end of phase 2 meeting with the FDA.
只是為了評論 CGRP——當然,現在有了結果,我們已經等待了慢性和偶發性的結果,並期待著我們與 FDA 的第二階段會議結束。
So this has not happened yet, but of course, are going together with both results.
所以這還沒有發生,但當然,這兩個結果都是一起發生的。
Chronic migraine being such an unmet need and affecting close to 6 million to 7 million women and about 2 million men in the United States alone, with no real therapy.
慢性偏頭痛是一種未得到滿足的需求,僅在美國就有近 600 萬至 700 萬女性和約 200 萬男性受到影響,而且沒有真正的治療方法。
The opportunity to think about some more rapid approach to approval -- we do not know yet, but these are, obviously, the cases we'll be making to regulatory authorities about this tremendous unmet need.
有機會考慮一些更快速的批准方法——我們還不知道,但顯然,這些是我們將向監管機構提出的關於這一巨大未滿足需求的案例。
And also, the tremendous efficacy, in terms of this approach, that we are really hoping that we, in some way, expedite this drug for patients who need it so badly.
而且,就這種方法而言,它具有巨大的功效,我們真的希望能夠以某種方式為急需該藥的患者提供這種藥物。
Just remember -- chronic migraine is the fourth most disabling condition known, above paralysis and above quadriplegia and angina, for example.
請記住,慢性偏頭痛是已知的第四大致殘性疾病,高於癱瘓、四肢癱瘓和心絞痛。
It's much more incapacitating.
這更加無能為力。
It is a very significant unmet need.
這是一個非常重要的未滿足的需求。
We have results that are compelling.
我們取得了引人注目的成果。
And we, of course, will be making this case to the FDA to expedite the opportunity to get this drug to patients.
當然,我們將向 FDA 提交此案,以加快將這種藥物提供給患者的機會。
- President and CEO
- President and CEO
And on the third one, you know, we assess dynamically and continuously our -- I would say, overall, [a well-balanced capital allocation] approach.
關於第三個,你知道,我們動態、持續地評估我們的——我想說,總體而言,[均衡的資本配置]方法。
And we continue doing it in a way which is fully associated with the initiatives which are underway.
我們將繼續以一種與正在進行的舉措完全相關的方式來做這件事。
Operator
Operator
Michael Faerm, Wells Fargo.
邁克爾·法爾姆,富國銀行。
- Analyst
- Analyst
Regarding Copaxone, does your new EPS guidance for the year assume one or two generic entrance this year?
關於 Copaxone,您今年的新 EPS 指導是否假定今年有一個或兩個通用入口?
And how much of an impact on guidance is it in one scenario versus another?
與另一種情況相比,它對指導的影響有多大?
- EVP and CFO
- EVP and CFO
Yes.
是的。
We assume two generic comparators until the end of the year.
我們假設到年底為止都會有兩個通用比較器。
Of course, it has an early entry.
當然,它有一個早期的入口。
We need to see where it is going to happen.
我們需要看看它會在哪裡發生。
As I mentioned earlier, we assume immediate entry now, as compared to our original assumption of a generic or two generic competitors in September.
正如我之前提到的,我們假設現在立即進入,而我們最初假設 9 月份有一個或兩個仿製藥競爭對手。
Of course, this has a negative impact of the number of [cents of EPS], but as you can see, there's more than enough to compensate for that coming from the rest of the business.
當然,這會對[每股收益的美分]數量產生負面影響,但正如您所看到的,有足夠的資金來彌補來自其他業務的影響。
- Analyst
- Analyst
In the event that there is only one, is there much of a positive impact there for you?
如果只有一個,對你有很大的積極影響嗎?
- EVP and CFO
- EVP and CFO
I guess it will be a little less competitive.
我想競爭會少一些。
Operator
Operator
Marc Goodman.
馬克·古德曼.
- Analyst
- Analyst
Siggi, you had mentioned in the prepared remarks about the Europe record profits -- better pricing you mentioned and stronger supply chain management.
Siggi,您在準備好的評論中提到了歐洲創紀錄的利潤——您提到的更好的定價和更強的供應鏈管理。
Can you just go into a little more detail on what you meant by better pricing and what you've done in the supply chain to improve things?
您能否更詳細地介紹一下更好的定價的含義以及您在供應鏈中為改進所做的工作?
And you mentioned some of the countries where performance is really good there, but could you go through some of the rest of the world -- like Latin America?
您提到了一些表現非常好的國家,但您能否介紹一下世界其他地區,例如拉丁美洲?
And did you mentioned that Russia had double-digit growth on constant currency, or was that even assuming the currency was such a mess?
您是否提到俄羅斯在固定匯率下實現了兩位數的增長,或者即使假設貨幣如此混亂?
And if you could go through some of the major countries overseas there and what's happening.
如果你能了解一下海外的一些主要國家以及正在發生的事情。
- President and CEO of Global Generic Medicines Group
- President and CEO of Global Generic Medicines Group
Absolutely, Mark.
當然,馬克。
I think, in Europe, we feel we have reached the bottom in the pricing.
我認為,在歐洲,我們覺得我們的定價已經觸底。
We even have seen some price increases in the market because the previous pricing was not sustainable.
我們甚至看到市場上有一些價格上漲,因為之前的定價是不可持續的。
We see that in probably markets like the Netherlands and other markets like that, which have a very low pricing.
我們可能會在荷蘭和其他類似的市場看到這一點,這些市場的定價非常低。
We haven't seen any further erosion, and we have seen a stabilization and even a little bit of an increase.
我們沒有看到任何進一步的侵蝕,我們看到了穩定,甚至有一點增長。
It is market by market, of course, where you deal with that.
當然,這是一個又一個市場的問題,你要在哪里處理這個問題。
I think, for example, in Germany, we had two very good launches in first quarter -- sevelamer and (inaudible).
我認為,例如,在德國,我們在第一季度推出了兩款非常好的產品——司維拉姆和(聽不清)。
The launches at risk we made in Germany in first quarter.
我們第一季度在德國推出的產品面臨風險。
Also on the supply chain, I think, the work that the supply chain and operation team in (inaudible) is outstanding.
另外,在供應鏈方面,我認為供應鍊和運營團隊(聽不清)的工作非常出色。
Our service levels are increasing year-on-year -- significantly better this year than a year ago.
我們的服務水平逐年提高——今年明顯好於一年前。
But also, we are improving our cost of goods that makes us more competitive in these lower-margin markets.
而且,我們正在提高商品成本,這使我們在這些利潤率較低的市場中更具競爭力。
If you go outside of Europe, Russia -- I mentioned -- basically there's double-digit growth in the branded generics, in terms of volume in Russia.
如果你走出歐洲,俄羅斯——我提到過——就俄羅斯的銷量而言,基本上品牌仿製藥有兩位數的增長。
And even with the FX impact, we are showing our growth in the Russian markets.
即使受到匯率影響,我們仍展示了我們在俄羅斯市場的增長。
Very impressive, both for the branded generics, but also they are a huge contributor to our OTC sale.
非常令人印象深刻,無論是品牌仿製藥,還是我們的非處方藥銷售的巨大貢獻者。
The Russians had a quite a bad cough and cold season, which we benefited on, also in the OTC sale.
俄羅斯人咳嗽和感冒的季節相當嚴重,我們也從非處方藥銷售中受益。
In Latin America, similar things.
在拉丁美洲,也有類似的事情。
Branded generics -- we are doing very well.
品牌仿製藥——我們做得很好。
We're focusing on our key brands.
我們專注於我們的主要品牌。
There is a new strategy in place of selecting fewer brands, which we are pushing more, similar to our specialty business, and we are seeing the benefit already from that.
有一個新的策略來代替選擇更少的品牌,我們正在推動更多的品牌,類似於我們的專業業務,我們已經看到了從中帶來的好處。
Also, we have seen a very strong OTC in the Latin America markets.
此外,我們還看到拉丁美洲市場的場外交易非常強勁。
Japan has still quite a challenging market.
日本仍然是一個充滿挑戰的市場。
We were having about single-digit operating profit last year, but the Japanese team launched a significant number of products in December, which we then introduced in, obviously, early this year in first quarter.
去年我們的營業利潤約為個位數,但日本團隊在 12 月推出了大量產品,然後我們顯然是在今年年初的第一季度推出了這些產品。
There's a little bit of a slow start.
起步有點慢。
We want to see a faster start in Japan, but already, we managed to get our operating profit to a very low double-digit profitability.
我們希望在日本看到更快的起步,但我們已經成功地將營業利潤提高到了非常低的兩位數盈利能力。
So in every market around the world, we are seeing the improvement.
因此,在全球每個市場,我們都看到了進步。
Very pleased.
很高興。
So yes, we have our strong launches.
所以,是的,我們推出了強勁的產品。
Esomeprazole is a great thing to have, but the underlying business is significantly improving in every market we are operating in today.
埃索美拉唑是一件很棒的事情,但我們今天經營的每個市場的基礎業務都在顯著改善。
- Analyst
- Analyst
When you talk about price increases, are you actually seeing the bottom out in Germany?
當你談論價格上漲時,你真的看到德國已經觸底嗎?
I know we've had this tender process that has been hurting that market for -- it must be -- five, six years now.
我知道我們的招標程序已經傷害了這個市場——肯定是——五年、六年了。
Where are we in that process?
我們在這個過程中處於什麼位置?
- President and CEO of Global Generic Medicines Group
- President and CEO of Global Generic Medicines Group
I think the tenders are here to stay.
我認為招標將繼續存在。
What we are doing -- our tender policy is we go into tenders which are profitable to Teva.
我們正在做的事情——我們的招標政策是我們進行對梯瓦有利可圖的招標。
We're not trying to increase our top line by participating in tenders that are questionable on the bottom line.
我們並不是試圖通過參與利潤有問題的投標來增加我們的收入。
We have an excellent team in Germany that looks at each and every tender.
我們在德國擁有一支優秀的團隊,負責審查每一項招標。
So I think the overall profitability for us in Germany has improved by being more diligent in the decision-making about what tenders to participate in.
因此,我認為,通過更加勤奮地決策參與哪些招標,我們在德國的整體盈利能力得到了提高。
That being said, I'm not sure if the overall pricing in Germany has improved that much.
話雖這麼說,我不確定德國的整體定價是否改善了那麼多。
But for us, the profitability has increased because of stronger management decisions made in that market.
但對我們來說,由於該市場做出了更強有力的管理決策,盈利能力有所增加。
Operator
Operator
Umer Raffat, ISI.
烏默·拉法特,三軍情報局。
- Analyst
- Analyst
I know you spoke about it briefly -- just a few minutes ago, as well -- but I wanted to drill into the $4.5 billion risk-adjusted new specialty revenues that you mentioned in the letter yesterday.
我知道你也簡短地談到過這個問題——就在幾分鐘前——但我想深入探討你在昨天的信中提到的 45 億美元的風險調整後新專業收入。
Can you break down for us what the key drivers are there?
您能為我們解釋一下主要驅動因素是什麼嗎?
And I have a follow-up for Michael.
我還有邁克爾的後續行動。
- President and CEO
- President and CEO
Rob, you start.
羅布,你開始吧。
- President and CEO of Global Specialty Medicines
- President and CEO of Global Specialty Medicines
Okay.
好的。
Pleasure (inaudible).
高興(聽不清)。
One of the key drivers is our entire respiratory franchise, which will add quite significantly, as we have already shared in the past, close to $1.5 billion in additional sales up to the end of 2019.
關鍵驅動因素之一是我們的整個呼吸系統特許經營權,正如我們過去所分享的那樣,到 2019 年底,該特許經營權將顯著增加近 15 億美元的額外銷售額。
And then, there is a number of launches in CNS, including the ones we discussed -- like laquinimod, pridopidine, we have hydrocodone, we have zecuity.
然後,中樞神經系統領域有許多產品上市,包括我們討論過的產品——比如拉喹莫德、普利多匹定、氫可酮、zecuity。
Obviously, the migraine products is going to be in there already.
顯然,偏頭痛產品已經在那裡了。
And then, the oxycodone ER is going to be in there.
然後,羥考酮緩釋劑就會在那裡。
All of them really have quite significant contributions, there.
他們所有人都確實做出了相當重大的貢獻。
And between those two -- really between the pain franchise and migraine franchise, the other CNS, and the respi, your really have, by far, the majority of the additional sales coming into that $4.5 billion.
在這兩者之間——實際上是在疼痛專營權和偏頭痛專營權之間,另一個 CNS 和 respi 之間,到目前為止,您確實擁有 45 億美元的額外銷售額的大部分。
- President and CEO
- President and CEO
(Multiple speakers) Umer, just to be clear here, this number does not include potential contribution from [hospice].
(多名發言者)Umer,這裡需要澄清的是,這個數字不包括[臨終關懷]的潛在貢獻。
- Analyst
- Analyst
Okay, great.
好的,太好了。
Michael, a question for you.
邁克爾,問你一個問題。
Given you have a lot of expense in Huntington's, both on the research side and the clinical side, so I wanted to get your perspective on SD-809 versus xenazine.
鑑於您在亨廷頓舞蹈症方面的費用很高,無論是研究方面還是臨床方面,所以我想了解您對 SD-809 與 Xenazine 的看法。
Specifically on efficacy, we know xenazine had a statistically significant worsening on UHDRS functional.
具體而言,就療效而言,我們知道 Xenazine 對 UHDRS 功能有統計學上顯著的惡化作用。
You guys did not show that data, so I wanted to understand how SD-809 is or isn't differentiated on the functional endpoint, specifically.
你們沒有展示這些數據,所以我想了解 SD-809 在功能端點上有何差異化。
And on the side effects side, how do you think about, as a practitioner, lower depression versus the weight gain we saw with SD-809?
在副作用方面,作為一名從業者,您如何看待 SD-809 降低抑鬱症與增加體重的作用?
- President of Global R&D and Chief Scientific Officer
- President of Global R&D and Chief Scientific Officer
Yes.
是的。
Just to comment, with regard to the side effect profile, what hasn't been shared in a lot of detail, but there was some of the just prepared and shared at the American Academy of Neurology meetings just last week.
只是評論一下,關於副作用概況,尚未詳細分享,但有一些剛剛在上週的美國神經病學學會會議上準備和分享的內容。
So what you saw with the SD-809 was improvement, not only in the chorea, which was very important, but also, there was improvement in [lestastonia] That was also significant.
因此,您在 SD-809 中看到的是改善,不僅在舞蹈病方面,這是非常重要的,而且,在 [lesastonia] 方面也有改善,這也很重要。
So there was improvement in a whole host of symptoms that were very significant, associated with no side effects.
因此,一系列症狀都得到了非常顯著的改善,而且沒有任何副作用。
So the xenazine, and in particular, the depression -- in a group of patients that are already have a much higher frequency of depression and a much higher risk of suicide in the general population, this has been a big fear for the physician.
因此,xenazine,特別是抑鬱症——在一群已經有更高頻率抑鬱症和更高自殺風險的患者中,這一直是醫生的一大擔憂。
Also, just to say, as part of this, also, there was a looking at the physician's impression of change and the patient's impression of change.
另外,我想說的是,作為其中的一部分,還考察了醫生對變化的印象和患者對變化的印象。
And all of these were very positive with this drug, compared to xenazine.
與 Xenazine 相比,所有這些都對這種藥物非常積極。
So the weight gain that you can see -- that is different, associated with this drug.
所以你看到的體重增加是不同的,與這種藥物有關。
Of course, these Huntington's patients have difficulty in swallowing, and I will come back to that in a moment.
當然,這些亨廷頓舞蹈病患者有吞嚥困難,我稍後會再談這個。
And these patients are very thin, so the weight gain is really, actually, quite welcome.
這些患者非常瘦,所以體重增加確實非常受歡迎。
It's not like they have become obese; it's just some restoration of weight.
他們並不是變胖了,而是變胖了。這只是體重的一些恢復。
Most importantly, what SD-809 showed, in part, the weight gain is because swallowing is improved.
最重要的是,SD-809 表明,體重增加部分是因為吞嚥功能得到改善。
Again, and we haven't really spoken about this, but SD-809 actually has some improvement in swallowing.
再說一遍,我們還沒有真正討論過這一點,但 SD-809 實際上在吞嚥方面有一些改善。
This is all good for the nutritional status of the patient.
這對於患者的營養狀況來說都是有好處的。
That is why they may be some increase in weight gain, and associated with that, because the swallowing has improved, there's less likelihood of aspiration and pneumonia from which many of these patients eventually die.
這就是為什麼他們的體重可能會有所增加,並且與此相關的是,因為吞嚥功能有所改善,所以許多患者最終死於誤吸和肺炎的可能性較小。
Overall, the impact is not just on chorea.
總體而言,影響不僅僅針對舞蹈症。
It has a broader impact on the quality of life, on the impression of change, on swallowing, other movement disorder.
它對生活質量、變化印象、吞嚥和其他運動障礙有更廣泛的影響。
All in all, is a net highly beneficial effect, compared to the tetrabenazine alone.
總而言之,與單獨使用丁苯那嗪相比,這是一種非常有益的淨效果。
- President and CEO
- President and CEO
That's the time to thank everyone for joining us today.
現在是感謝大家今天加入我們的時候了。
And I look forward to continuing the interaction with you.
我期待與您繼續互動。
Operator
Operator
Thank you, sir.
謝謝你,先生。
That does conclude our conference for today.
我們今天的會議到此結束。
Thank you for participating.
感謝您的參與。
You may now disconnect.
您現在可以斷開連接。