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 day and welcome to today's Bristol-Myers Squibb Company's first-quarter sales earnings and conference call.
美好的一天,歡迎來到今天的百時美施貴寶公司第一季度銷售收益和電話會議。
Today's call is being recorded.
今天的通話正在錄音。
At this time for opening remarks and introductions, I would like to turn the call over to the Vice President of Investor Relations Mr. John Elicker.
現在,我想將電話轉給投資者關係副總裁 John Elicker 先生進行開幕致辭和介紹。
Please go ahead, sir.
請繼續,先生。
- VP of IR
- VP of IR
Thanks, Denise.
謝謝,丹妮絲。
And good morning, everybody.
大家早上好。
Thanks for joining us.
感謝您加入我們。
We are here this morning to discuss our first-quarter 2005 earnings performance.
今天上午我們在這裡討論 2005 年第一季度的收益表現。
As you've probably already seen in our press release this morning.
正如您可能已經在我們今天早上的新聞稿中看到的那樣。
With us we have Peter Dolan, our Chairman, Chief Executive Officer;
我們的主席兼首席執行官 Peter Dolan;
Andrew Bonfield, Chief Financial Officer; and Elliott Sigal, our Chief Scientific Officer.
安德魯·邦菲爾德,首席財務官;以及我們的首席科學官 Elliott Sigal。
They will each have prepared remarks and then we'll go to your Q&A.
他們每個人都會準備好發言,然後我們將進行問答。
First, I will handle the legal disclosures.
首先,我將處理法律披露。
During the call we may make various remarks about the Company's future expectations, plans, and prospects that constitute forward-looking statements for purposes of the Safe Harbor Provisions under the Private Securities and Litigation Reform Act of 1995.
在電話會議期間,我們可能會就公司的未來預期、計劃和前景發表各種言論,這些言論構成前瞻性陳述,以符合 1995 年《私人證券和訴訟改革法案》中的安全港條款的目的。
Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Company's most recent Annual Report on Form 10-K and in our periodic reports on Form 10-Q.
由於各種重要因素,包括公司最新的 10-K 表年度報告和 10-Q 表定期報告中討論的因素,實際結果可能與這些前瞻性陳述所示的結果存在重大差異。
These documents are available from the SEC, the BMS website or from Bristol-Myers Investor Relations.
這些文件可從 SEC、BMS 網站或百時美施貴寶投資者關係部獲取。
In addition, any forward-looking statements represent our estimates only as of today and should not be relied upon as representing our estimates as of any subsequent date.
此外,任何前瞻性陳述僅代表我們截至今天的估計,不應被視為代表我們截至任何後續日期的估計。
With that, let me turn it over to Peter Dolan, our Chairman and CEO.
接下來,讓我把它交給我們的董事長兼首席執行官彼得·多蘭。
- Chairman, President, CEO
- Chairman, President, CEO
Thanks, John.
謝謝,約翰。
And good morning, everyone.
大家早上好。
Before Andrew takes you into the details of the quarter results, I want to talk about how the first three months of the year fit into our broader strategy and our outlook.
在安德魯向您詳細介紹季度業績之前,我想談談今年前三個月如何適應我們更廣泛的戰略和前景。
We've also asked Elliott Sigal to join us to give you an R&D update since we have had some important developments in that area as well.
我們還邀請 Elliott Sigal 加入我們,為您提供研發最新信息,因為我們在該領域也取得了一些重要進展。
And then following Elliott's remarks, all of us will be available to answer your questions.
在埃利奧特發言之後,我們所有人都將可以回答您的問題。
Let's begin by reviewing first-quarter earnings.
讓我們首先回顧一下第一季度的收益。
Non-GAAP earnings from continuing operations were $0.34 per share, excluding specified items, which were in line with Wall Street's mean estimate.
不計特定項目,持續經營業務的非 GAAP 收益為每股 0.34 美元,與華爾街的平均預期一致。
On a GAAP basis, fully-diluted earnings per share for the first quarter were $0.32.
按 GAAP 計算,第一季度完全攤薄每股收益為 0.32 美元。
Our first-quarter financial results were in line with expectations around the EPS challenges we are facing this year and next, related to the transition of our Rx portfolio.
我們第一季度的財務業績符合我們今年和明年面臨的與 Rx 投資組合轉型相關的每股收益挑戰的預期。
The Company is on plan and our non-GAAP earning per share guidance for the year remains unchanged.
公司正在按計劃進行,我們今年的非公認會計準則每股收益指導保持不變。
Also, we continue to expect a return to sales and earnings growth in 2007 as our pipeline advances, our portfolio transitions more fully to growth drivers for the future, and the impact of recent and impending exclusivity losses runs its course.
此外,我們繼續預計,隨著我們的產品線不斷推進、我們的投資組合更充分地轉變為未來的增長動力,以及近期和即將發生的獨家經營權損失的影響逐漸結束,我們將繼續預計 2007 年銷售和盈利將恢復增長。
We continue to move forward, executing our strategy to build leadership in our ten disease areas of focus where there is significant unmet medical need.
我們繼續前進,執行我們的戰略,在我們的十個重點疾病領域建立領導地位,這些領域存在大量未得到滿足的醫療需求。
We recently launched Baraclude, a potent new treatment for Hepatitis B that will give us a presence in this important disease area.
我們最近推出了博路定,這是一種有效的乙型肝炎新療法,將使我們在這一重要疾病領域佔有一席之地。
Baraclude represents the fourth new drug launch for Bristol-Myers Squibb in the last two and a half years.
博路定是百時美施貴寶在過去兩年半中推出的第四個新藥。
In addition to Baraclude, we've moved forward with our Src/ABL kinase inhibitor for CML, a form of Leukemia, and with LEA 29Y for prevention of solid organ transplant rejection.
除了博路定之外,我們還推出了用於治療 CML(一種白血病)的 Src/ABL 激酶抑製劑,以及用於預防實體器官移植排斥反應的 LEA 29Y。
And we remain hopeful about our submissions for muraglitazar and abatacept, which are being reviewed by the FDA.
我們對正在接受 FDA 審查的 muraglitazar 和 abatacept 的申請仍然充滿希望。
Elliott will be talking to you about these and other achievements by his R&D team in just a few minutes.
埃利奧特將在短短幾分鐘內向您介紹他的研發團隊的這些成就和其他成就。
As for currently-marketed products, the first quarter saw continued solid performance of our newer growth drivers including Abilify, Reyataz, and Erbitux, as well as Plavix.
就目前上市的產品而言,第一季度我們的新增長動力包括 Abilify、Reyataz、Erbitux 以及波立維 (Plavix) 繼續表現強勁。
Abilify continues to demonstrate robust growth in the U.S. and should benefit from a recent additional indication for maintenance in bipolar mania, as well as in new oral solution formulation.
Abilify 在美國繼續表現出強勁的增長,並應受益於最近維持雙相躁狂症的額外適應症以及新的口服溶液製劑。
It now has an approximately 11% share of the monthly new Rxs in the anti-psychotics class.
目前,它在抗精神病藥物類別的每月新處方中約佔 11% 的份額。
We are also pleased with Abilify's performance in Europe where it was introduced last June.
我們也對 Abilify 去年 6 月在歐洲推出的表現感到滿意。
Reyataz sales nearly doubled from the prior year, bolstered by its European introduction in the second quarter of last year.
得益於去年第二季度在歐洲的推出,Reyataz 的銷售額比去年增長了近一倍。
Reyataz has broken through the 30% level in terms of weekly new Rxs in the protease inhibitor class in the U.S. and now several key European markets.
在美國以及現在的幾個主要歐洲市場,Reyataz 的蛋白酶抑製劑類每週新處方數量已突破 30% 的水平。
Erbitux also continued to show solid performance in the first quarter.
愛必妥在第一季度也繼續表現強勁。
Sales of Plavix continue to grow at double-digit rates, and we are hopeful about continued strong growth based on the findings of two recent trials, Clarity and Commit.
波立維的銷售額繼續以兩位數的速度增長,根據最近兩項試驗 Clarity 和 Commit 的結果,我們對持續強勁增長抱有希望。
On the patent litigation around Plavix, we are pleased with the decision in the case in Canada, but we do not believe that the outcome should be predictive of the outcome in the U.S., as there are different rules and procedures.
關於波立維的專利訴訟,我們對加拿大案件的判決感到滿意,但我們認為結果不應預測美國的結果,因為有不同的規則和程序。
We and our partner, Sanofi-Aventis continue to believe that the patent is valid and has been infringed and we intend to rigorously defend our intellectual property on Plavix.
我們和我們的合作夥伴賽諾菲-安萬特仍然認為該專利有效並且已被侵犯,我們打算嚴格捍衛我們在波立維上的知識產權。
In addition to our pharmaceutical products, our Health Care businesses continue to be important contributors to our overall strength and stability.
除了我們的藥品之外,我們的醫療保健業務仍然是我們整體實力和穩定性的重要貢獻者。
This is especially true of our Mead Johnson nutritional fitness in the first quarter, which grew worldwide sales 11%, excluding the impact of the sale of the Adult Nutritionals business.
我們的美贊臣營養健身第一季度尤其如此,其全球銷售額增長了 11%(不包括成人營養品業務出售的影響)。
Looking ahead, even in this challenging EPS environment, we are continuing to invest in the business, building on last year's 12% increase in research and development, with a 7% increase in the first quarter of 2005 over the same period in the prior year, excluding milestone payments for licenses.
展望未來,即使在 EPS 充滿挑戰的環境下,我們仍將繼續對業務進行投資,在去年研發投入增長 12% 的基礎上,2005 年第一季度比上年同期增長 7% ,不包括許可證的里程碑付款。
We expect to accelerate R&D spend over the rest of 2005 and are now planning on low double-digit growth for the year.
我們預計 2005 年剩餘時間將加快研發支出,目前計劃今年實現兩位數的低增長。
For the remainder of the year, our outlook remains unchanged.
對於今年剩餘時間,我們的前景保持不變。
We continue to estimate our fully-diluted EPS from continuing operations to be between $1.35 and $1.45 on a non-GAAP basis, excluding potential specified items, which are outlined in today's press release.
我們繼續預計,按照非公認會計準則計算,持續經營業務的完全攤薄每股收益將在 1.35 美元至 1.45 美元之間,不包括今天新聞稿中概述的潛在指定項目。
Now let me turn things over to Andrew Bonfield.
現在讓我把事情交給安德魯·邦菲爾德。
- CFO, SVP
- CFO, SVP
Thank you, Peter.
謝謝你,彼得。
I would like to briefly discuss our first-quarter results.
我想簡要討論一下我們第一季度的業績。
As you'll have seen the release, fully-diluted earnings per share from continuing operations for the quarter were $0.32, negatively impacted by $0.02 of specified items.
正如您在新聞稿中所看到的,本季度持續經營業務的完全攤薄每股收益為 0.32 美元,受到 0.02 美元指定項目的負面影響。
Excluding specified items, fully-diluted earnings per share on a non-GAAP basis were $0.34 meeting the First Call mean estimate.
不包括特定項目,按非 GAAP 計算的完全稀釋每股收益為 0.34 美元,符合 First Call 平均預期。
The full reconciliation of GAAP to non-GAAP earnings per share is posted on our website.
GAAP 與非 GAAP 每股收益的完整調節表已發佈在我們的網站上。
Sales from continuing operations were $4.5 billion down 3%.
持續經營業務銷售額為 45 億美元,下降 3%。
The sales performance resulted from a 2% increase due to foreign exchange rate fluctuations, offset by a negative 4% decline from volumes.
由於匯率波動,銷售業績增長了 2%,但被銷量下降 4% 所抵消。
Price impact was flat year-on-year.
價格影響與去年同期持平。
U.S. pharmaceutical sales were down 10% at $1.8 billion.
美國藥品銷售額下降 10%,至 18 億美元。
Sales were impacted by exclusivity losses, principally Paraplatin in the Metformin franchise, as well as a decline in U.S.
銷售額受到專營權損失(主要是二甲雙胍特許經營權中的帕拉鉑)以及美國市場銷量下降的影響。
Pravachol sales.
普伐膽銷售。
Our key growth drivers in the U.S., Plavix, Avapro, Erbitux, Reyataz, and Abilify had another strong quarter with U.S. sales of $1.1 billion versus $897 million in the comparative period last year.
我們在美國的主要增長動力,波立維 (Plavix)、阿瓦普羅 (Avapro)、愛必妥 (Erbitux)、雷亞塔茲 (Reyataz) 和 Abilify 再次表現強勁,美國銷售額為 11 億美元,而去年同期為 8.97 億美元。
These key growth drivers made up 62% of U.S. sales for the quarter, compared to 45% last year.
這些主要增長動力佔本季度美國銷售額的 62%,而去年這一比例為 45%。
Changes in wholesale inventory levels had little impact on growth rates in the quarter as inventory levels for our key U.S. pharmaceutical brands at the end of the first quarter were in line with the levels at the end of last year.
批發庫存水平的變化對本季度的增長率影響不大,因為我們主要的美國製藥品牌第一季度末的庫存水平與去年年底的水平一致。
As is our practice, we have included U.S. wholesaler levels for our key brands on our website.
按照我們的慣例,我們在網站上列出了我們主要品牌的美國批發商級別。
International pharmaceutical sales grew by 4% to $1.8 billion, including a 5% benefit from foreign exchange.
國際藥品銷售額增長 4%,達到 18 億美元,其中 5% 的外匯收益。
The sales decline excluding FX is primarily due to the increased competition in Europe for Pravachol and Taxol, partially offset by growth in Reyataz and Abilify.
不包括外彙在內的銷售額下降主要是由於歐洲對 Pravachol 和 Taxol 的競爭加劇,但部分被 Reyataz 和 Abilify 的增長所抵消。
Now let me move on to a few of our key products.
現在讓我談談我們的一些關鍵產品。
Worldwide traffic sales increased 17% to $814 million, this is on the strength of a 15% increase in U.S. script volume.
全球流量銷售額增長了 17%,達到 8.14 億美元,這是由於美國劇本量增長了 15%。
Worldwide of Pravachol sales of $520 million were down 23%.
Pravachol 的全球銷售額為 5.2 億美元,下降了 23%。
U.S. sales declined 25% due to a 17% decline in scripts and a related reduction in wholesale inventory levels.
由於腳本下降 17% 以及批發庫存水平的相關減少,美國銷售額下降了 25%。
International sales were down 20% due to exclusivity losses in Europe, principally in the UK, Netherlands and Germany.
由於歐洲(主要是英國、荷蘭和德國)的獨家經營權喪失,國際銷售額下降了 20%。
We reported $188 million in total revenue for Abilify, including $27 million Internationally.
我們報告 Abilify 的總收入為 1.88 億美元,其中國際收入為 2700 萬美元。
This translates to approximately $278 million in sales for the compound, as we report only 65% of revenue in the U.S. and certain International markets.
這意味著該化合物的銷售額約為 2.78 億美元,因為我們報告的收入僅占美國和某些國際市場的 65%。
Success in the U.S. continues with new script share of over 11% for the most recent week.
在美國繼續取得成功,最近一周新劇本份額超過 11%。
In Europe, our launch continues to go well with the value share exceeding 4% in most markets.
在歐洲,我們的產品發布繼續進展順利,在大多數市場的價值份額超過 4%。
We expect to launch in France during the second half of the year.
我們預計將於今年下半年在法國推出。
Sales for Reyataz, our novel protease inhibitor were $149 million.
我們的新型蛋白酶抑製劑 Reyataz 的銷售額為 1.49 億美元。
Reyataz now has approximately 30% new script share of the U.S. protease inhibitor market, excluding Ritonavir.
Reyataz 目前在美國蛋白酶抑製劑市場(不包括利托那韋)中佔有約 30% 的新藥配方份額。
Additionally, Reyataz sales include 57 million in International revenue, with strong market shares being reported in a number of European markets, and it is already the No. 2 protease inhibitor in France, Germany and the UK.
此外,Reyataz 的銷售額包括 5700 萬美元的國際收入,在許多歐洲市場都有強勁的市場份額,並且它已經是法國、德國和英國的第二大蛋白酶抑製劑。
Erbitux sales were $87 million for the quarter, basically flat compared to the fourth quarter of last year.
Erbitux 本季度銷售額為 8700 萬美元,與去年第四季度基本持平。
The market remains competitive, so we are pleased to note that the end of 2004 Erbitux ranked as one of the top ten new product launches.
市場競爭依然激烈,因此我們很高興地註意到,2004年底Erbitux被評為推出的十大新產品之一。
Now let me move on to our Nutritionals and related health care businesses.
現在讓我談談我們的營養品和相關醫療保健業務。
Excluding the divestment of the Adult Nutritionals business, Mead Johnson sales grew by 11% to $526 million.
不包括成人營養品業務的撤資,美贊臣銷售額增長 11%,達到 5.26 億美元。
Strong International sales growth continued, up 13%, driven by increases in infant formula and children's nutritionals.
在嬰兒配方奶粉和兒童營養品增長的推動下,國際銷售額繼續強勁增長,增長了 13%。
ConvaTec and Medical Imaging both reported sales growth for the quarter.
ConvaTec 和 Medical Imaging 均報告本季度銷售額增長。
ConvaTec was up 5%, primarily due to continued strength in wound therapeutics.
ConvaTec 上漲 5%,主要是由於傷口治療的持續強勁。
And Medical Imaging was up 4%, as Cardiolite had another strong quarter, up 11%.
醫學影像業務上漲 4%,而 Cardiolite 季度業績又強勁,上漲 11%。
I will now move on to the rest of the profit and loss account.
我現在將討論損益賬戶的其餘部分。
The gross margin in the quarter was 69.8% compared to 70.8% in the first quarter of last year.
本季度毛利率為69.8%,而去年第一季度為70.8%。
I would remind you that this excludes the impact from the OTM business in both periods.
我想提醒大家的是,這不包括兩個時期OTM業務的影響。
Specified items reduced gross margin by 0.3% in both periods as well.
兩個時期內的特定項目毛利率也均下降了 0.3%。
The margin decline was primarily due to mix in the U.S. business, including the impact of the Paraplatin and Metformin exclusivity losses, and the introduction of Erbitux.
利潤率下降主要是由於美國業務的混合,包括帕拉鉑和二甲雙胍獨家經營權損失的影響以及愛必妥的推出。
Marketing, selling and administration expenses were down 4% due to flat sales force expense reflecting changes to our sales force, infrastructure consistent with our strategy, and lower non-clinical grant spending in the U.S. pharmaceuticals.
營銷、銷售和管理費用下降了 4%,原因是銷售隊伍費用持平,反映出我們的銷售隊伍、符合我們戰略的基礎設施的變化,以及美國藥品非臨床撥款支出的減少。
Advertising and promotion spend was up 1% with increased spending behind Abilify, Reyataz and Erbitux, offset by lower spending on more mature brands.
廣告和促銷支出增長了 1%,其中 Abilify、Reyataz 和 Erbitux 支出增加,但被更成熟品牌的支出減少所抵消。
Excluding specified items, research and development expense for the quarter increased 7% to $617 million.
不包括特定項目,該季度的研發費用增長 7%,達到 6.17 億美元。
This increase is primarily driven by spending on increased resources behind development projects, including late-stage development spending on the Src/ABL and MDX-010.
這一增長主要是由於開發項目背後的資源支出增加所致,包括 Src/ABL 和 MDX-010 的後期開發支出。
Including specified items, R&D spending increased 12% to $653 million.
包括特定項目在內,研發支出增長 12%,達到 6.53 億美元。
Specified items include milestone payments to [inaudible] and Miterix [ph].
指定項目包括向 [聽不清] 和 Miterix [ph] 支付的里程碑付款。
First-quarter pharmaceutical R&D spending increased as a percentage of sales to 16.2% from 14.8% in 2004.
第一季度藥品研發支出佔銷售額的比例從 2004 年的 14.8% 上升至 16.2%。
Equity income from affiliates decreased by 6 million as a result of unfavorability in our share of ImClone related to litigation settlements, partially offset by an increase in minority interest income received from the sale of Sanofi JV products outside the U.S.
由於我們在 ImClone 中與訴訟和解相關的股份受到不利影響,來自附屬公司的股權收入減少了 600 萬美元,但部分被在美國境外銷售賽諾菲合資公司產品所獲得的少數股東權益收入的增加所抵消。
Minority interest expense, net of taxes, increased by 15 million to $122 million, primarily as a result of the continued strong growth of Plavix in the U.S.
少數股東利息支出(稅後)增加了 1500 萬美元,達到 1.22 億美元,這主要是由於波立維在美國的持續強勁增長。
Let me talk a little bit about the tax rate.
我先簡單談談稅率。
For the first quarter, the effective tax rate from continuing operations before minority interest and income taxes, and excluding specified items, increased 28.1% from 24.2% last year.
第一季度,扣除少數股東利息和所得稅(不包括特定項目)的持續經營業務的有效稅率從去年的 24.2% 增長了 28.1%。
This equates to approximately $0.02 in earnings per share.
這相當於每股收益約 0.02 美元。
The first-quarter tax rate was principally -- was higher principally due to lower foreign tax credits and a higher provision for tax contingencies.
第一季度稅率較高,主要是由於外國稅收抵免減少和稅務意外準備金增加。
You will recall that during our conference call in January I discussed the tax rate for 2005 being higher during the first part of the year and coming down by year end as a result of the expected benefit from the resolution of ongoing tax audits, which will be accounted for in the period in which the audits are resolved.
您可能還記得,在 1 月份的電話會議上,我曾討論過 2005 年的稅率在今年上半年較高,到年底則下降,這是由於正在進行的稅務審計的解決方案帶來的預期收益,這將是計入審計解決期間。
Consistent with our previous guidance, I still expect that the full-year rate to come in about the 2003 full-year rate.
與我們之前的指導一致,我仍然預計全年增長率將約為 2003 年全年增長率。
Operating cash flow remains strong and net debt at the end of the quarter declined to $2.6 billion versus $2.9 billion at the end of last year.
運營現金流依然強勁,本季度末淨債務降至 26 億美元,而去年年底為 29 億美元。
During the quarter, we repatriated approximately $6 billion of the $9 billion of unremitted earnings that we indicated we would bring back under the Homeland Investment Act.
在本季度,我們匯回了 90 億美元未匯出收入中的約 60 億美元,我們表示將根據《國土投資法》將這些收入帶回國內。
We plan on repatriating the remainder later in 2005 and will use these funds consistent with the guidelines as issued by the U.S. Treasury.
我們計劃在 2005 年晚些時候匯回剩餘資金,並將按照美國財政部發布的指導方針使用這些資金。
As you will see in our press release, we are confirming our previously issued full-year 2005 adjusted non-GAAP earnings per share of $1.35 to $1.45.
正如您將在我們的新聞稿中看到的那樣,我們確認之前發布的 2005 年全年調整後非 GAAP 每股收益為 1.35 美元至 1.45 美元。
We are, however, raising our GAAP guidance to $1.37 to $1.47 based on our expectations for insurance recoveries related to litigation settlements, partially offset by charges related to early debt retirement.
然而,根據我們對與訴訟和解相關的保險賠償的預期,我們將 GAAP 指引提高至 1.37 美元至 1.47 美元,部分被與提前債務清償相關的費用所抵消。
Again, the full reconciliation is posted on our website.
同樣,完整的對賬結果已發佈在我們的網站上。
The only change from the sales and expense guidance we provided in January is in the R&D line.
與我們一月份提供的銷售和費用指導相比,唯一的變化是在研發領域。
As Peter mentioned, we now expect R&D spending to increase in the low double-digit range, excluding specified items.
正如彼得所提到的,我們現在預計研發支出將在低兩位數範圍內增長,不包括特定項目。
In summary, our first-quarter performance was in line with our own expectations and First Call mean estimates.
總而言之,我們第一季度的業績符合我們自己的預期和首次呼叫平均預期。
Our growth drivers, newly-launched products and other healthcare businesses continue to perform well.
我們的增長動力、新推出的產品和其他醫療保健業務繼續表現良好。
Our 2005 guidance reflects continued execution against our strategy.
我們 2005 年的指導反映了我們對戰略的持續執行。
And now let me turn it over to Elliott.
現在讓我把它交給埃利奧特。
Thank you.
謝謝。
- President of Pharmaceutical Research Institute and Chief Scientific Officer
- President of Pharmaceutical Research Institute and Chief Scientific Officer
Thank you, Andrew.
謝謝你,安德魯。
Good morning, everyone.
大家,早安。
Our R&D organization continues to build momentum, and we are very pleased with the progress we have made in the first quarter in 2005 in executing our strategy and delivering our pipeline.
我們的研發組織繼續發展勢頭,我們對 2005 年第一季度在執行我們的戰略和交付我們的產品線方面取得的進展感到非常滿意。
A number of major pipeline milestones were achieved recently and I would like to highlight these.
最近實現了一些主要的管道里程碑,我想強調一下這些。
As Peter mentioned, in late March, the FDA approved Baraclude, entecevir, our oral anti-viral for the treatment of Hepatitis B. This marks our fourth approval in less than two and a half years.
正如 Peter 提到的,三月下旬,FDA 批准了我們的口服抗病毒藥物博路定(恩替西韋)用於治療乙型肝炎。這標誌著我們在不到兩年半的時間裡第四次獲得批准。
Baraclude, which received priority review was discovered in our own laboratories and meets a significant, unmet medical need.
博路定獲得了優先審查,是在我們自己的實驗室中發現的,滿足了重大的、未滿足的醫療需求。
We met all primary end points in our Phase III program and demonstrated superiority to the existing standard of care in 8 out of 9 measures of efficacy.
我們達到了 III 期項目的所有主要終點,並在 9 項療效指標中的 8 項中證明了優於現有護理標準。
We are in regulatory review with Baraclude in Europe and China, and we anticipate a submission in Japan by year's end.
我們正在歐洲和中國與博路定進行監管審查,預計年底前將在日本提交申請。
The FDA recently accepted for review the new drug application for muraglitazar, our dual P par [ph] agonist for Diabetes, which we submitted in December.
FDA 最近接受審查 muraglitazar 的新藥申請,muraglitazar 是我們用於治療糖尿病的雙 P par [ph] 激動劑,我們於 12 月提交了該申請。
We will present phase three data for muraglitazar at the American Diabetes Association meeting in June.
我們將在 6 月份的美國糖尿病協會會議上公佈 muraglitazar 的第三階段數據。
We believe this potential first-in-class agent that we are developing and intend to market in partnership with Merck, could be an important addition to the armamentarium in the fight against the epidemic of Diabetes.
我們相信,我們正在開發並打算與默克公司合作銷售的這種潛在的一流藥物,可能會成為抗擊糖尿病流行的武器庫的重要補充。
At the end of March, we completed our rolling biologics license application for Abatacept, a biologic with a novel mechanism of action for the treatment of rheumatoid Arthritis.
3月底,我們完成了阿巴西普的滾動生物製劑許可申請,阿巴西普是一種具有治療類風濕關節炎新作用機制的生物製劑。
We plan to present Phase III data at the compound at the European League Against Rheumatism, ULAR Congress in June.
我們計劃在 6 月份的歐洲抗風濕病聯盟 ULAR 大會上展示該化合物的 III 期數據。
We believe Abatacept, if approved, will deliver a much-needed new treatment option for patients who suffer from this debilitating disease.
我們相信,阿巴西普如果獲得批准,將為患有這種使人衰弱的疾病的患者提供急需的新治療選擇。
On the life cycle management front this past quarter, we continue to expand the profile of Abilify with the approval in the U.S. for maintaining efficacy in patients with bipolar mania, which follows on our approval last September for the treatment of acute bipolar mania.
在生命週期管理方面,上個季度,我們繼續擴大 Abilify 的知名度,繼去年 9 月批准用於治療急性雙相躁狂症之後,Abilify 在美國獲得批准用於維持雙相躁狂患者的療效。
We also received approval for the oral solution formulation of Abilify, which became available in the first quarter.
我們還獲得了 Abilify 口服溶液製劑的批准,該製劑已於第一季度上市。
The most recent additions to the large body of Plavix clinical data are the results of Clarity and Commit.
Plavix 大量臨床數據的最新補充是 Clarity 和 Commit 的結果。
Studies in patients with acute myocardial infarctions.
急性心肌梗死患者的研究。
These results were presented at the American College of Cardiology in March and the Clarity results were published in the New England Journal of Medicine.
這些結果於三月份在美國心髒病學會發表,Clarity 結果發表在《新英格蘭醫學雜誌》上。
Both of these studies, which included a total of nearly 50,000 patients, demonstrated that Plavix, given in addition to standard therapy, provided significant benefits to patients with ST elevation acute myocardial infarction.
這兩項研究總共納入了近 50,000 名患者,結果表明,在標準治療的基礎上給予波立維,可以為 ST 段抬高型急性心肌梗塞患者帶來顯著的益處。
With clinical trial experience in over 100,000 patients, we continue to expand the dataset on Plavix, demonstrating it as the standard of care for patients at risk for life-threatening athro-thrombotic events.
憑藉超過 100,000 名患者的臨床試驗經驗,我們繼續擴展 Plavix 的數據集,證明它是面臨危及生命的動脈血栓事件風險的患者的護理標準。
More data from significant ongoing trials will be presented next year.
來自正在進行的重大試驗的更多數據將於明年公佈。
The nature of R&D is that even in the best of times there will be some delays and disappointments.
研發的本質是,即使在最好的時期,也會出現一些延誤和失望。
We announced with our partner Imclone that the SBLA for Erbitux in head and neck cancer, which we previously expected to file by the end of the second quarter, would now be filed by the end of this year.
我們與合作夥伴 Imclone 宣布,我們之前預計在第二季度末提交的 Erbitux 治療頭頸癌的 SBLA 現在將在今年年底提交。
Also, we terminated our alliance with Corgentech for edifoligide after reviewing the Phase III data for the trial of its use in coronary artery bypass.
此外,在審查了 edifoligide 用于冠狀動脈搭橋試驗的 III 期數據後,我們終止了與 Corgentech 的聯盟。
Our full development portfolio is progressing at good pace.
我們的完整開發組合正在快速進展。
EMSAM is a transdermal MAO inhibitor for depression that was in license from Somerset Pharmaceuticals for the U.S. and Canada.
EMSAM 是一種治療抑鬱症的透皮 MAO 抑製劑,已獲得薩默塞特製藥公司在美國和加拿大的許可。
EMSAM received an approvable letter from the FDA, and we are currently in discussions with the agency.
EMSAM 收到了 FDA 的批准函,目前我們正在與該機構進行討論。
Ixabepilone, our novel epothilone is in development for the treatment of metastetic breast cancer in taxane resistent patients.
伊沙匹隆(Ixabepilone)是我們正在開發的新型埃博黴素,用於治療紫杉烷耐藥患者的轉移性乳腺癌。
The Phase III program is well underway.
第三階段計劃正在順利進行中。
Also in Phase III, Vinflunine is a new micro tubal inhibitor of the treatment of bladder cancer that was in license last year from Pierre Fabre.
同樣處於 III 期階段的 Vinflunine 是一種治療膀胱癌的新型微輸卵管抑製劑,去年獲得了 Pierre Fabre 的許可。
MDX-010 is a monoclonal antibody that was recently in license with Medarex.
MDX-010 是一種單克隆抗體,最近獲得 Medarex 許可。
The Phase III program for the treatment of melanoma is also well underway.
治療黑色素瘤的三期計劃也在順利進行中。
I would like to highlight two of our compounds that recently transitioned to registrational programs.
我想重點介紹我們最近過渡到註冊計劃的兩個化合物。
The Src/ABL kinase inhibitor for chronic myelogenous Leukemia.
用於慢性粒細胞白血病的 Src/ABL 激酶抑製劑。
And bellatacip [ph], also known as LEA-29Y for the prevention of rejection of solid organ transplant.
而bellatacip[ph],也稱為LEA-29Y,用於預防實體器官移植的排斥反應。
Results of our Phase I study with the Src/ABL kinase inhibitor were very encouraging with complete hematologic responses, as well as cytogenetic responses in this often fatal disease.
我們使用 Src/ABL 激酶抑製劑進行的 I 期研究結果非常令人鼓舞,在這種常常致命的疾病中實現了完整的血液學反應以及細胞遺傳學反應。
You can look for more recent data to be presented at the upcoming ASCO meeting in May.
您可以查找即將在 5 月份舉行的 ASCO 會議上公佈的最新數據。
We have begun our phase II program, which we hope will be the registrational program and have received fast-track designation from the FDA.
我們已經開始了第二階段計劃,我們希望該計劃將成為註冊計劃,並已獲得 FDA 的快速通道指定。
We are very encouraged by the progress we are making with this program.
我們對該計劃所取得的進展感到非常鼓舞。
Phase III trials have been initiated for bellatacip [ph] for solid organ transplant following promising results in Phase II trials.
繼 II 期試驗取得可喜的結果後,bellatacip [ph] 用於實體器官移植的 III 期試驗已經啟動。
These Phase II trials will be presented at the American Transplant Congress next month.
這些二期試驗將於下個月在美國移植大會上公佈。
We hope that this novel biologic will show advantages over the current standard of care, the calcineurin inhibitors.
我們希望這種新型生物製劑將顯示出優於當前護理標準(鈣調神經磷酸酶抑製劑)的優勢。
To summarize, we have had a very productive period recently with continued generation of new indications, formulations, and exciting data for growth drivers, such as Abilify and Plavix.
總而言之,我們最近度過了一個非常富有成效的時期,不斷產生新的適應症、配方和令人興奮的增長動力數據,例如 Abilify 和 Plavix。
We have received approval on the first of our recent three submissions with the Baraclude approval and are working closely with the FDA as they review our applications for muraglitazar in Diabetes and Abatacept in rheumatoid Arthritis.
我們最近提交的三份申請中的第一份獲得了博路定的批准,並且正在與 FDA 密切合作,審查我們的 muraglitazar 治療糖尿病和 Abatacept 治療類風濕關節炎的申請。
We continue to progress the other compounds in our full development portfolio and add to this the important part our pipeline with the recent additions and transitions of Src/ABL kinase inhibitor and Bellatacip [ph].
我們繼續推進我們完整開發組合中的其他化合物,並通過最近添加和轉換 Src/ABL 激酶抑製劑和 Bellatacip [ph] 為我們的產品線添加重要部分。
I'd like to turn things back to John.
我想把事情轉回給約翰。
- VP of IR
- VP of IR
Thanks, Elliott.
謝謝,埃利奧特。
And, Denise, I think we're ready to move to Q&A now.
丹尼斯,我想我們現在已經準備好進入問答環節了。
If I could ask, in the interest of time, if we could limit your questions to one, or at least related questions in your series.
為了節省時間,我能否問一下,我們是否可以將您的問題限制為一個問題,或者至少是您系列中的相關問題。
So, Denise, whenever you're ready.
所以,丹妮絲,只要你準備好了。
Operator
Operator
Very good, sir. [OPERATOR INSTRUCTIONS] The first question, gentlemen, is coming from Jim Kelly of Goldman Sachs.
非常好,先生。 [操作員說明] 先生們,第一個問題來自高盛的吉姆·凱利。
- Analyst
- Analyst
Good morning, and thank you.
早上好,謝謝。
I wanted to ask about Plavix growth.
我想問一下波立維的生長情況。
And the new prescription -- or total prescription growth, pardon me, is still quite strong, but decelerating somewhat.
新處方——或者說總處方增長,請原諒,仍然相當強勁,但有所放緩。
And I am just interested in how much of that growth is being driven by a lengthening of therapy versus new patients coming in and what the prospects are over the next, call it, year or two given the dataset?
我只是感興趣的是,與新患者相比,這種增長有多少是由治療時間延長推動的,以及給定數據集的未來一年或兩年的前景如何?
Thank you.
謝謝。
- Chairman, President, CEO
- Chairman, President, CEO
Jim, worldwide sales for Plavix during the first quarter were about 800 million up 17% with strong growth in International markets.
Jim,波立維第一季度全球銷售額約為 8 億,增長 17%,國際市場增長強勁。
As you know, we are working off quite a big base at this point.
如您所知,我們目前正在建立一個相當大的基礎。
In the U.S., sales increased by 15%, while total Rxs were also up 15% off this very large base.
在美國,銷售額增長了 15%,而處方藥總量也比這個龐大的基數增長了 15%。
It is important to note that the total Rx growth represents a combined retail and mail order measure.
值得注意的是,總處方藥增長代表了零售和郵購的綜合衡量指標。
To your specifics about increasing length of therapy.
關於增加治療時間的具體情況。
Increasing the length of therapy is shifting business from retail to mail order, therefore, the mix is playing a role as the mail order business is growing at a faster pace than retail.
治療時間的延長正在將業務從零售轉向郵購,因此,隨著郵購業務的增長速度快於零售,這種混合正在發揮作用。
The growth rates that we experienced the last couple of years in 2003 and 2004 were really strong due to guideline changes as a result of the CURE data.
由於 CURE 數據導致的指導方針發生變化,我們在 2003 年和 2004 年的過去幾年經歷了非常強勁的增長率。
The positive impact of these guidelines in the prior periods impacted comparable growth.
這些指導方針在前期的積極影響影響了可比增長。
We and Sanofi continue to focus on increasing penetration rates, spending length of therapy in indicated patient populations for Plavix, and in addition to all of that, we are continuing to focus on increasing compliance as patients transfer from the acute setting.
我們和賽諾菲繼續致力於提高波立維在指定患者群體中的滲透率和治療時間,除此之外,我們還繼續致力於提高患者從急性環境轉移時的依從性。
- President of Pharmaceutical Research Institute and Chief Scientific Officer
- President of Pharmaceutical Research Institute and Chief Scientific Officer
Jim, this is Elliott Sigal.
吉姆,這是埃利奧特·西格爾。
With regard to the new dataset, the results of Clarity and Commit clearly establish the benefit risk potential of Plavix when used on top of standard therapy, including thrombolitics in the medical management of this set of acute myocardial infarction patients.
關於新數據集,Clarity 和 Commit 的結果清楚地確定了波立維在標準治療(包括在這組急性心肌梗死患者的醫療管理中使用血栓形成藥物)基礎上使用時的潛在獲益風險。
Based upon these new clinical data, we will be meeting with health authorities in both U.S. and Europe to discuss the study results, and their support for an indication and the alliance with Sanofi and BMS intend to prepare an application for submission by the end of the year.
根據這些新的臨床數據,我們將與美國和歐洲的衛生當局會面,討論研究結果以及他們對適應症的支持,並與賽諾菲和百時美施貴寶聯盟計劃在年底前準備提交申請年。
- VP of IR
- VP of IR
Thanks, Jim.
謝謝,吉姆。
Denise, can we go to the next question, please
丹尼斯,我們可以進入下一個問題嗎?
Operator
Operator
Absolutely.
絕對地。
The next question is coming from David Risinger of Merrill Lynch.
下一個問題來自美林證券的大衛·瑞辛格。
- Analyst
- Analyst
Thanks very much.
非常感謝。
Could you please provide some color on the cost cutting that is now behind the Company, and the cost cutting that is ahead.
您能否提供一些關於公司現在和未來的成本削減的信息。
Thank you.
謝謝。
- CFO, SVP
- CFO, SVP
David, as I indicated in my comments, sales force expense actually was flat for the year -- for the quarter.
大衛,正如我在評論中指出的那樣,銷售人員費用實際上與本季度持平。
We have restructured our sales force, as you know, focusing around specialists in our primary-care area, focusing on the CV metabolics area principally, and based our sales force size around the 2007 expectations for the business with existing products and also new products like muraglitazar.
如您所知,我們重組了我們的銷售隊伍,重點關注初級保健領域的專家,主要關注心血管代謝領域,並根據 2007 年對現有產品和新產品(如穆拉格列扎。
So we focused on that.
所以我們專注於此。
That is being reflected in the quarter, we've done some other things around the rest of the world.
這在本季度得到了體現,我們在世界其他地區也做了一些其他事情。
Within other expense areas, obviously we continue to look at our expense base.
在其他支出領域,顯然我們會繼續關注我們的支出基礎。
For example, we have recently announced some outsourcing with Accentia and also with British Telecom, and we will continue to focus and look for ways of maintaining, as we said, in line with our strategy, all other expenses outside the R&D and A&P line broadly flat, so trying to offset the increases due to inflation in that record.
例如,我們最近宣布與 Accentia 以及英國電信進行一些外包,我們將繼續關注並尋找方法,以維持研發和 A&P 線之外的所有其他費用,正如我們所說,符合我們的戰略持平,因此試圖抵消該記錄中通貨膨脹造成的增長。
- VP of IR
- VP of IR
Thanks, David.
謝謝,大衛。
Denise, can we go to the next question, please.
丹尼斯,我們可以進入下一個問題嗎?
Operator
Operator
The next question from Carl Seiden of UBS.
下一個問題來自瑞銀集團的卡爾·賽登。
- Analyst
- Analyst
Thanks very much.
非常感謝。
A question on muraglitazar, which I suppose is for Elliott.
關於穆拉格列扎的問題,我想是問埃利奧特的。
I think you guys have disclosed some of the muraglitazar data on efficacy, but not a lot has been published yet on its side effect profile.
我想你們已經披露了一些 muraglitazar 的功效數據,但關於其副作用的資料還沒有公佈。
I think you've described rates of edema seen as being comparable to the TZDs.
我認為您所描述的水腫率與 TZD 相當。
I'm wondering if you could offer any more detail on that issue now or will that data be published at the ADA?
我想知道您現在是否可以提供有關該問題的更多詳細信息,或者該數據是否會在 ADA 上發布?
Also on muraglitazar, any sense for how the positive lipid effect for muraglitazar compares to the positive lipid effect seen for Actose.
另外,對於 muraglitazar,對於 muraglitazar 的積極脂質作用與 Actose 所見的積極脂質作用相比有何意義。
And is any head-to-head data versus Actose in the cards?
是否有任何與 Actose 的正面對比數據?
Thanks.
謝謝。
- President of Pharmaceutical Research Institute and Chief Scientific Officer
- President of Pharmaceutical Research Institute and Chief Scientific Officer
Thank you, Carl.
謝謝你,卡爾。
This is Elliott.
這是埃利奧特。
Well, you were correct in referencing what we disclosed November 17 at our R&D day.
嗯,您引用我們 11 月 17 日研發日披露的內容是正確的。
We are pleased to say that we submitted 16 abstracts to the American Diabetes Association meeting, the upcoming meeting, and they have been accepted.
我們很高興地說,我們向即將舉行的美國糖尿病協會會議提交了 16 份摘要,並且它們已被接受。
There will be a mixture of oral presentations, high-profile presentations, posters and abstracts.
將會有口頭演講、高調演講、海報和摘要的混合形式。
We studied over 4,800 patients for this medicine.
我們對 4,800 多名患者進行了該藥物的研究。
Our goal in this area of clear unmet medical need is to achieve better glycemic control, better durability response, and a significant impact, substantial impact on lipids.
在這一明顯未滿足的醫療需求領域,我們的目標是實現更好的血糖控制、更好的持久反應,並對血脂產生顯著、實質性的影響。
The Phase III data on these studies, monotherapy, combination therapy, and a comparator trial with Actose will be described all at the upcoming ADA meeting.
這些研究、單一療法、聯合療法以及 Actose 對照試驗的 III 期數據將在即將召開的 ADA 會議上進行描述。
This is the first, as far as I am aware of, registrational trial in Diabetes in the U.S. that is under submission with an active comparator control.
據我所知,這是美國第一個正在提交積極對照對照的糖尿病註冊試驗。
And we -- with regard to the comparison of lipid effect, it is important to look at these head-to-head trials and not just historical data.
我們——關於脂質效應的比較,重要的是要查看這些面對面的試驗,而不僅僅是歷史數據。
So this -- this information will be discussed publicly in June.
所以這個信息將在六月公開討論。
- VP of IR
- VP of IR
Thanks, Carl.
謝謝,卡爾。
Denise can we go to the next question, please
丹尼斯,我們可以進入下一個問題嗎?
Operator
Operator
The next question is coming from Timothy Anderson from Prudential Equity Group.
下一個問題來自 Prudential Equity Group 的蒂莫西·安德森 (Timothy Anderson)。
- Analyst
- Analyst
Thank you.
謝謝。
On the pipeline, a couple of questions on a couple of products.
在管道中,有幾個關於幾種產品的問題。
Abatacept, where are you guys in lining up a third-party supplier for manufacturing?
阿巴西普,你們在哪裡尋找第三方製造供應商?
And do you expect that this product will go up for an Advisory Committee meeting?
您預計該產品會參加諮詢委員會會議嗎?
And then on muraglitazar, can you just update us on potential timing of Advisory Committee meeting there and tell us what the exact indications are that you filed on and do you expect this would be a first-line therapy per the label.
然後,關於 muraglitazar,您能否向我們介紹諮詢委員會在那裡舉行會議的可能時間,並告訴我們您提交的確切適應症是什麼,以及您是否預計這將是根據標籤的一線治療。
- Chairman, President, CEO
- Chairman, President, CEO
Jim, let me take the first part of that question in terms of third-party manufacturing.
吉姆,讓我從第三方製造方面回答這個問題的第一部分。
As you know, we finalized the BLA at the end of March, and at this point, we are hoping for a priority review; however, that's a decision that is still resting with the FDA.
如您所知,我們在 3 月底完成了 BLA,此時我們希望得到優先審查;然而,這仍由 FDA 做出決定。
We expect to file the SBLA for the approval of Lonza manufacturing during the fourth quarter of 2005 or the early part of Q1 2006.
我們預計將在 2005 年第四季度或 2006 年第一季度初提交 SBLA 以獲得 Lonza 製造的批准。
As we've said, we plan to generate initial supply from our Syracuse facility; however, we need Lonza in order to support a broad product launch and what we believe would be full market demand.
正如我們所說,我們計劃從我們的錫拉丘茲工廠產生初始供應;然而,我們需要 Lonza 來支持廣泛的產品發布以及我們認為的充分市場需求。
- President of Pharmaceutical Research Institute and Chief Scientific Officer
- President of Pharmaceutical Research Institute and Chief Scientific Officer
Tim, this is Elliott on your questions on both Abatacept, as well as on muraglitazar.
蒂姆,我是埃利奧特,我將回答您關於阿巴西普以及莫拉格列扎的問題。
You asked about the potential Advisory Committee for Abatacept.
您詢問了阿巴西普可能成立的諮詢委員會。
We submitted -- we completed the submission of our rolling BLA at the end of March, and the application is under review by the FDA.
我們於 3 月底完成了滾動 BLA 的提交,該申請正在接受 FDA 的審查。
It is up to them to announce the acceptance of the file and any plan for an Advisory Committee, and that hasn't been announced yet.
由他們來宣布接受該文件以及成立諮詢委員會的任何計劃,但目前尚未宣布。
I would say both with Abatacept and muraglitazar, and potentially for more and more compounds in front of the agency, that we can expect a robust discussion about benefit risk of any new agent.
我想說的是,無論是阿巴西普(Abatacept)和穆拉格列扎(muraglitazar),還是潛在的越來越多的化合物,我們都可以期待對任何新藥的獲益風險進行激烈的討論。
And so it would not be surprising to have Advisory Committees, perhaps even more routinely than before.
因此,設立諮詢委員會也就不足為奇了,甚至可能比以前更加頻繁。
We are preparing for an Advisory Committee just to be prepared for both compounds for muraglitazar.
我們正在籌備成立一個諮詢委員會,專門為 muraglitazar 的兩種化合物做好準備。
We have been preparing for some time for an Advisory Committee.
我們為成立諮詢委員會已經準備了一段時間。
Again, that decision is up to the FDA and hasn't been announced.
同樣,該決定由 FDA 做出,尚未公佈。
The action date for muraglitazar is in October, so we would anticipate the timing to be some time a month or so before that, and it is up to the FDA to announce that.
muraglitazar 的行動日期是 10 月,因此我們預計時間會在此之前一個月左右的某個時間,這將由 FDA 宣布。
You did ask a question about labeling on muraglitazar, which will be up to the FDA.
您確實詢問了有關 muraglitazar 標籤的問題,這將由 FDA 決定。
We did a very robust clinical program, including monotherapy, treating naive patients, patients that have failed metformin, patients that have failed sofanil uria [ph], combination therapy, and this is all important data that we think that should be included in the label.
我們做了一個非常強大的臨床計劃,包括單一療法、治療初治患者、二甲雙胍失敗的患者、索凡尼尿[ph]失敗的患者、聯合治療,這些都是我們認為應該包含在標籤中的重要數據。
That discussion will be up to the agency.
該討論將由該機構決定。
- VP of IR
- VP of IR
Great.
偉大的。
Thanks a lot, Tim.
非常感謝,蒂姆。
Denise, can we go to the next question, please.
丹尼斯,我們可以進入下一個問題嗎?
Operator
Operator
The next question is coming from Jami Rubin of Morgan Stanley.
下一個問題來自摩根士丹利的賈米·魯賓。
- Analyst
- Analyst
Thank you.
謝謝。
I have a couple of questions.
我有一些問題。
First, again, this to Andrew, and this again relates to marketing, selling and admin, which was down this quarter.
首先,這又是關於安德魯的,這又與營銷、銷售和管理有關,本季度有所下降。
Can you be a little more specific on the plan for rightsizing the sales force.
您能否更具體地介紹一下銷售隊伍精簡計劃。
Have you cut as much as you plan to in primary care?
您在初級保健方面的削減是否達到了計劃的程度?
Or is there further to go with Prava going off patent next year.
或者說,隨著 Prava 明年專利到期,還有進一步的進展嗎?
And secondly, is the sales force right size for the upcoming launch of new products?
其次,銷售隊伍的規模是否適合即將推出的新產品?
And as we look out and modeling this line item going forward, should we anticipate that this line item grows more in line with historical trends.
當我們展望未來並對該訂單項進行建模時,我們是否應該預期該訂單項的增長更符合歷史趨勢。
My second question is for Elliott, you didn't mention Rezaxoban [ph], the factored 10-A, I was just wondering if you could clarify its status.
我的第二個問題是問 Elliott,您沒有提到 Rezaxoban [ph],即因子 10-A,我只是想知道您是否可以澄清其狀態。
And my third question, and I apologize for this, but the obligatory question on MMA.
我的第三個問題,我對此表示歉意,但這是關於 MMA 的必答問題。
Peter or Andrew if you could take this.
彼得或安德魯,如果你能接受這個。
Just wondering what your early initial discussions have been with the third-party buyers on MMA and your sense for what volume and price is likely to look like.
只是想知道您早期與 MMA 第三方買家的初步討論是什麼,以及您對可能的銷量和價格的感覺。
Thanks.
謝謝。
- CFO, SVP
- CFO, SVP
Jami, on the first -- the first question, CV metabolic sales force has been right-sized for the launch of new products, including muraglitazar, so that basically is set as is now.
Jami,關於第一個問題,CV 代謝銷售隊伍已經針對新產品(包括 muraglitazar)的推出進行了適當規模的調整,因此基本上是現在的情況。
And as you look at the sales force, we would not anticipate any further changes going forward from now, obviously the benefits of some of those changes will be felt already for the remainder of this year.
當你看看銷售隊伍時,我們預計從現在開始不會有任何進一步的變化,顯然,其中一些變化的好處將在今年剩餘時間內感受到。
- President of Pharmaceutical Research Institute and Chief Scientific Officer
- President of Pharmaceutical Research Institute and Chief Scientific Officer
Jami, this is Elliott.
賈米,這是埃利奧特。
You asked about our factor 10-A program, which is an oral approach to this anti-thrombolitic for the purpose of a variety of applications, both on the venous side and the arterial side.
您詢問了我們的 10-A 因子計劃,該計劃是一種口服抗血栓藥物,可用於靜脈側和動脈側的多種應用。
We are still very excited about this approach.
我們仍然對這種方法感到非常興奮。
We have had a series of compounds, some of them in the clinic.
我們有一系列化合物,其中一些已用於臨床。
Rezaxoban [ph] was one of our compounds.
Rezaxoban [ph] 是我們的化合物之一。
We have announced previously that Rezaxoban helped us prove the concept, but that we found a profile of a drug that is now in Phase II that we preferred advanced.
我們之前已經宣布,Rezaxoban 幫助我們證明了這個概念,但我們發現了一種目前處於 II 期的藥物的概況,我們更喜歡先進的藥物。
So we have not continued development of Rezaxoban.
所以我們沒有繼續開發Rezaxoban。
But we were very active in the factor 10-A area and our second compound in that series is advancing further in clinical development.
但我們在 10-A 因子領域非常活躍,該系列的第二種化合物正在臨床開發中取得進一步進展。
- Chairman, President, CEO
- Chairman, President, CEO
Jami, I was just going to come back to your sales force question and then MMA.
Jami,我正要回到你的銷售人員問題,然後是 MMA。
We put our strategy in place, we said we were going to organize and structure the Company to take advantage of the portfolio that we envisioned in the future.
我們制定了戰略,我們說我們將組織和構建公司,以利用我們未來設想的投資組合。
So as part of that, we have completed the restructuring of both the U.S. and European sales forces consistent with our strategy.
因此,作為其中的一部分,我們已經根據我們的戰略完成了美國和歐洲銷售隊伍的重組。
As you know in the U.S., we reduced the primary care sales force and refocused them to be a cardiovascular metabolics team, consistent with the products that we have in the portfolio like Plavix and Avapro and Pravachol.
如您所知,在美國,我們減少了初級保健銷售人員,並將其重新調整為心血管代謝團隊,這與我們的波立維 (Plavix)、Avapro 和 Pravachol 等產品組合中的產品一致。
That structure also helps us position us for the launch of muraglitazar, which hopefully in 2005, 2006 pending FDA approval.
該結構還有助於我們為 muraglitazar 的上市做好準備,該藥物有望在 2005 年、2006 年等待 FDA 批准。
Same type of activity went on in Europe.
歐洲也有類似的活動。
Additionally, we built and strengthened our specialty forces in areas like neuroscience, HIV and oncology.
此外,我們還建立並加強了神經科學、艾滋病毒和腫瘤學等領域的專業力量。
As you know, we launched entecavir, and we have a small dedicated sales force focused on physicians who treat Hepatitis B. In addition, we have plans in place for strategic sales resources for the launch of Abatacept pending FDA approval.
如您所知,我們推出了恩替卡韋,並且我們有一支專門針對治療乙型肝炎的醫生的小型銷售隊伍。此外,我們還制定了戰略銷售資源計劃,用於推出等待 FDA 批准的阿巴西普。
So lots of activity has already taken place as we gear up for implementing our strategy and for the portfolio of the future.
因此,在我們準備實施我們的戰略和未來的投資組合時,已經開展了許多活動。
On the Medicare Modernization Act question.
關於醫療保險現代化法案問題。
What we have -- have communicated in the past, we continue to believe that it will have a -- in our planning for the future, it will have a neutral to slightly negative impact, although we expect the volume impact to be positive, we think that the overall impact could potentially be slightly negative.
我們過去所傳達的信息,我們仍然相信,在我們未來的規劃中,它將產生中性至輕微負面影響,儘管我們預計數量影響是積極的,但我們認為總體影響可能會略有負面。
That's what is built into our plans.
這就是我們計劃中的內容。
If it turns out to be more positive than that, that would be a positive in an upside.
如果結果比這更積極,那將是一個積極的上行空間。
In terms of any ongoing negotiations with potential providers, we're currently involved in contract negotiations with a number of them.
就與潛在供應商正在進行的任何談判而言,我們目前正在與其中一些供應商進行合同談判。
The process continues to evolve.
這個過程繼續發展。
We are pleased with the progress we have made so far.
我們對迄今為止所取得的進展感到高興。
It is still early in the process.
目前還處於早期階段。
We expect the impact of Part D overall to be better understood probably in the next six to 12 months.
我們預計 D 部分的總體影響可能會在未來 6 到 12 個月內得到更好的理解。
But as I said, as we go through our planning, we are assuming a neutral to negative impact with any increase in volumes offset by pricing pressure.
但正如我所說,在我們制定計劃時,我們假設銷量的任何增加都會受到價格壓力的抵消,從而產生中性至負面影響。
- VP of IR
- VP of IR
Thanks, Denise.
謝謝,丹妮絲。
Can we go to the next question, please.
我們可以進入下一個問題嗎?
Operator
Operator
The next question is coming from Tony Butler with Lehman Brothers.
下一個問題來自雷曼兄弟的托尼·巴特勒。
- Analyst
- Analyst
Good morning and thank you.
早上好,謝謝。
Just a simple question on Avapro related to lower average selling price.
只是關於 Avapro 的一個簡單問題,與較低的平均售價有關。
Can you comment on that market and why, in fact, you have been discounting price at a heavier rate in order to capture share and is that a practice that will continue on a forward-looking basis?
您能否評論一下這個市場?事實上,為什麼您一直在以更高的價格打折以獲取份額,這種做法是否會在前瞻性的基礎上繼續下去?
Thank you very much.
非常感謝。
- CFO, SVP
- CFO, SVP
Thanks, Tony.
謝謝,托尼。
It's Andrew.
是安德魯。
As regards Avapro, please note that actually for the -- four of the last five months we have actually ARP Class in new script growth.
至於 Avapro,請注意,實際上在過去五個月中的四個月裡,我們實際上在新腳本中增加了 ARP 類。
We are very pleased with that performance.
我們對這樣的表現非常滿意。
Obviously, we did see strong growth in total scripts in the quarter, and as you mentioned average selling prices were down due to an increase in discounting levels.
顯然,我們確實看到本季度總腳本的強勁增長,正如您提到的,由於折扣水平的增加,平均售價下降了。
What has made the comparison of quarter-on-quarter more difficult is the increase in wholesale inventory which we are seeing in the first quarter of last year.
使季度環比比較變得更加困難的是我們在去年第一季度看到的批發庫存的增加。
That is part of the negative view on sales versus scripts.
這是對銷售與劇本的負面看法的一部分。
Also, though, we are continuing to see an increase in discounts required to maintain or expand access in third-party plans.
不過,我們還繼續看到維持或擴大第三方計劃的訪問權限所需的折扣有所增加。
That will continue to impact net sales -- net sales growth as we go forward.
隨著我們的發展,這將繼續影響淨銷售額——淨銷售額的增長。
So, yes, the discounting will remain to a certain degree going forward.
所以,是的,折扣未來仍將保持在一定程度。
- VP of IR
- VP of IR
Thanks, Tony.
謝謝,托尼。
Denise, can we go to the next question, please.
丹尼斯,我們可以進入下一個問題嗎?
Operator
Operator
The next question comes from Steve Scala of SG Cowen.
下一個問題來自 SG Cowen 的 Steve Scala。
- Analyst
- Analyst
Thank you.
謝謝。
The R&D guidance was increased from mid to high single digits to low double, but all other guidance parameters were unchanged.
研髮指導從中高個位數提高到低雙位數,但所有其他指導參數均保持不變。
So I'm wondering if you can elaborate on the offsets, or should we assume that the earnings likely will be at the lower end of the range versus what would have been the case three months ago.
因此,我想知道您是否可以詳細說明抵消額,或者我們是否應該假設收益可能會處於該範圍的下限(與三個月前的情況相比)。
And just to clarify, does the R&D guidance include or exclude specified items?
需要澄清的是,研髮指南是否包含或排除特定項目?
- CFO, SVP
- CFO, SVP
Steve, it is Andrew.
史蒂夫,這是安德魯。
The R&D guidance, as we noted, excludes specified items that -- that would be increased in low double-digit range is X specified items.
正如我們所指出的,研髮指南不包括 X 個指定項目,這些項目將在低兩位數範圍內增加。
Secondly, the point we did increase it from is from the mid to high single-digit range, to the low double-digit range.
其次,我們增加的點是從中高個位數範圍到低兩位數範圍。
That increase is a fairly small and can be absorbed within the variation of other expenses that we see within the expense base.
這一增長相當小,可以通過我們在費用基礎中看到的其他費用的變化來吸收。
So at this point in time, it does not indicate any change within our overall prospects for the year.
因此,目前來看,這並不表明我們今年的總體前景有任何變化。
- VP of IR
- VP of IR
Thanks, Steve.
謝謝,史蒂夫。
Denise, can we go to the next question, please.
丹尼斯,我們可以進入下一個問題嗎?
Operator
Operator
The next question is coming from Chris Shibutani of JPMorgan.
下一個問題來自摩根大通的 Chris Shibutani。
- Analyst
- Analyst
Thank you very much.
非常感謝。
Questions on International opportunities for in-line and pipeline for Abilify and Abatacept.
關於 Abilify 和 Abatacept 的在線和管道的國際機會的問題。
For Abilify you mentioned launching in France in the second half here.
對於 Abilify,您提到下半年在法國推出。
I am not sure if this was a little later relative to our second-quarter expectations.
我不確定這是否比我們第二季度的預期晚了一點。
If you can comment on that, as well as what other major European markets we should expect and timeline.
如果您可以對此發表評論,以及我們應該期待的其他主要歐洲市場和時間表。
And on Abatacept, could you help us understand what the International timelines might be for filings, particularly in Europe there?
關於阿巴西普,您能否幫助我們了解國際申請時間表,特別是在歐洲?
Thank you.
謝謝。
- Chairman, President, CEO
- Chairman, President, CEO
Well, on Abilify in Europe, during 2004, early part of 2005, we launched in all major European markets with the exception of France.
嗯,關於歐洲的 Abilify,2004 年、2005 年初,我們在除法國以外的所有主要歐洲市場推出了該產品。
We expect to launch in France within the first half of the year.
我們預計將於今年上半年在法國推出。
In the other markets where we have had early launches, Abilify demand has exceeded the uptick of Zyprexa at its comparable time of launch.
在我們早期推出的其他市場中,Abilify 的需求量已經超過了 Zyprexa 在其可比推出時間的增長。
The share that we have in the anti-psychotics class continues to grow in key launch markets.
我們在抗精神病藥物類別中所佔的份額在主要上市市場中持續增長。
We've already got 4% in most markets, with a high of close to 10% in Denmark, Germany and the U.K., all showing good progress as well.
我們在大多數市場的佔有率已經達到 4%,其中丹麥、德國和英國的佔有率最高接近 10%,所有這些市場也都取得了良好的進展。
Our market research indicates that physicians have strong perceptions of the efficacy and side effect profile, and we see particularly strong results in physicians' perceptions of the efficacy of Abilify for cognition and for negative symptoms.
我們的市場研究表明,醫生對 Abilify 的功效和副作用有強烈的認識,並且我們看到醫生對 Abilify 對認知和陰性症狀的功效的認識特別強烈。
So we are pleased with what's happening in the U.S.
因此,我們對美國發生的事情感到高興。
We are very encouraged by what's happening in Europe, and we expect to launch in France within the first half of the year.
我們對歐洲發生的事情感到非常鼓舞,我們預計將在今年上半年在法國推出。
- President of Pharmaceutical Research Institute and Chief Scientific Officer
- President of Pharmaceutical Research Institute and Chief Scientific Officer
The question was on the filing in Europe for Abatacept.
問題是關於阿巴西普在歐洲的申請。
And the plan now is to complete our application for submission by the end of this year for Europe.
現在的計劃是在今年年底前完成歐洲的提交申請。
- VP of IR
- VP of IR
Thanks, Chris.
謝謝,克里斯。
Denise, I think we have time for about two more questions.
丹尼斯,我想我們還有時間再問兩個問題。
Operator
Operator
All right, sir.
好吧,先生。
The next question is coming from David Moskowitz of Friedman, Billings, Ramsey.
下一個問題來自弗里德曼、比林斯、拉姆齊的大衛·莫斯科維茨。
- Analyst
- Analyst
Yes, thanks for the question.
是的,謝謝你的提問。
Good morning.
早上好。
On the gross margin, I am just trying to get a handle for the base expectations.
在毛利率方面,我只是想了解基本預期。
Came in at almost 70%, which was higher than what we were expecting, and I saw U.S.
幾乎達到了 70%,這比我們預期的要高,而且我看到了美國。
Pravachol sales were significantly down year-over-year.
Pravachol 的銷售額同比大幅下降。
So it looks like you are absorbing that.
所以看起來你正在吸收它。
Can you talk about, again, the base gross margin and what we should expect going forward?
您能否再次談談基本毛利率以及我們對未來的預期?
Thanks.
謝謝。
- CFO, SVP
- CFO, SVP
Yes, David.
是的,大衛。
Guidance for the year was that the rates of erosion of the gross margin, there would be gross margin erosion as we go through the year, but the rate would slow down, the first quarter, the underlying margin decline was 0.7%.
今年的指引是毛利率的侵蝕率,隨著全年的發展,毛利率會出現侵蝕,但侵蝕率會放緩,第一季度的基本利潤率下降了 0.7%。
We shouldn't -- last year I think the average was around 1% per quarter.
我們不應該——去年我認為平均每季度約為 1%。
That is an indication of what we expect for for the year.
這表明了我們對今年的預期。
- VP of IR
- VP of IR
Thanks, David.
謝謝,大衛。
Denise, can we go to the next question, please.
丹尼斯,我們可以進入下一個問題嗎?
Operator
Operator
The next question from Catherine Arnold of Credit Suisse First Boston.
下一個問題來自瑞士信貸第一波士頓的凱瑟琳·阿諾德。
- Analyst
- Analyst
Hi, this is Marshal Gordon on behalf of Catherine.
大家好,我是代表凱瑟琳的戈登元帥。
We had questions on rebating for additional key products for Plavix and Pravachol in the quarter and how those may have changed either year-over-year or quarter-over-quarter.
我們對本季度波立維 (Plavix) 和 Pravachol 的其他關鍵產品的回扣以及這些回扣與去年同期或與季度相比可能發生的變化有疑問。
Thanks.
謝謝。
- CFO, SVP
- CFO, SVP
On Plavix, the rate of discounting has not changed at all quarter-on-quarter.
在波立維(Plavix)上,折扣率環比沒有任何變化。
On Pravachol, as we indicated in the fourth quarter, there are a number of plans where we didn't meet the volume guidance last year, and that meant that we didn't give additional discounts.
關於 Pravachol,正如我們在第四季度所指出的,有許多計劃沒有達到去年的銷量指導,這意味著我們沒有提供額外的折扣。
In the first quarter, there is a different mix.
在第一季度,情況有所不同。
So actually the level of rebating actually did increase versus the fourth quarter of last year; however, that is dependent on the mix of the -- the portfolio, and which plans actually are taking the product.
事實上,與去年第四季度相比,回扣水平確實有所增加;然而,這取決於產品組合的組合,以及哪些計劃實際上正在採用該產品。
So that varies from quarter to quarter.
因此,每個季度的情況都會有所不同。
But overall, there is no real additional -- actual additional discounting being given on Pravachol, it was a factor of mix in the quarter.
但總體而言,Pravachol 並沒有真正的額外折扣,這是本季度混合的一個因素。
- VP of IR
- VP of IR
Thanks, Marshal.
謝謝,元帥。
Denise, I think we have time for one last question.
丹尼斯,我想我們有時間回答最後一個問題。
Operator
Operator
Very good, sir.
非常好,先生。
The last question is coming from Steve Slaughter of UBS.
最後一個問題來自瑞銀集團的史蒂夫·斯勞特。
- Analyst
- Analyst
Thanks for the question.
謝謝你的提問。
Just wondering if you can comment a bit on Baraclude in terms of receptivity at the managed care level, given this premium pricing.
只是想知道,考慮到這種溢價,您是否可以對博路定在管理式醫療水平的接受度方面發表一些評論。
How is that being adopted on formularities?
公式中如何採用這一點?
And secondarily, I would be interested in what the filing timelines might look like for that product in the Asian markets in particular and then other OUS markets.
其次,我對該產品在亞洲市場(尤其是其他美國市場)的申請時間表可能會感興趣。
- President of Pharmaceutical Research Institute and Chief Scientific Officer
- President of Pharmaceutical Research Institute and Chief Scientific Officer
With regard to the filing time -- timelines for Baraclude in the Asian markets, we have submitted in China.
關於申請時間——博路定在亞洲市場的時間表,我們已經在中國提交了。
You asked about Asia, but we have also submitted, I'll remind everybody, in Europe.
你問的是亞洲,但我提醒大家,我們也提交了歐洲的情況。
So we are working a regulatory review in Europe and China.
因此,我們正在歐洲和中國進行監管審查。
We are preparing and tend to complete our filing in Japan by the end of this year.
我們正在準備併計劃在今年年底前完成在日本的申請。
- Chairman, President, CEO
- Chairman, President, CEO
And on -- on Baraclude and receptivity so far, et cetera, got approved on March 29th.
到目前為止,博路定和接受性等等,已於 3 月 29 日獲得批准。
We have, as I said earlier, dedicated field specialists in the U.S. who were working with the healthcare community to address Hepatitis B and educate people on the appropriate treatment.
正如我之前所說,我們在美國有專門的現場專家,他們正在與醫療保健界合作解決乙型肝炎問題並教育人們採取適當的治療方法。
Obviously, it's very early.
顯然,現在還很早。
We are in the first weeks of this, but we've got 1.3% share of total Rx's and a much higher share of new Rx's at about 4.1%.
我們正處於這方面的最初幾週,但我們已佔 Rx 總數的 1.3%,而新 Rx 的份額要高得多,約為 4.1%。
Very early days, but we have an enthusiastic sales force out there who are encouraged by what they are seeing in the early weeks.
雖然還很早,但我們有一支熱情的銷售隊伍,他們對前幾週所看到的情況感到鼓舞。
- VP of IR
- VP of IR
Thanks, Steve, and I think that's about all the time we have for questions.
謝謝,史蒂夫,我想這就是我們提問的全部時間了。
That's going to wrap up our call this morning.
我們今天早上的通話就到此結束。
As always, if anybody has any questions, you can call either myself or Blaine Davis in Investor Relations here in New York.
與往常一樣,如果有人有任何疑問,您可以致電我本人或紐約投資者關係部門的 Blaine Davis。
Denise, thanks very much for your help.
丹尼斯,非常感謝你的幫助。
Operator
Operator
You are very welcome, sir.
非常歡迎您,先生。
This concludes today's conference call.
今天的電話會議到此結束。
You may disconnect.
您可以斷開連接。