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Operator
Operator
Ladies and gentlemen, thank you for standing by, and welcome to the Q4 2017 earnings call.
女士們先生們,感謝你們的支持,歡迎參加 2017 年第四季度財報電話會議。
(Operator Instructions) And as a reminder, this conference is being recorded.
(操作員說明)作為提醒,本次會議正在錄製中。
I would now like to turn the conference over to our host, Mr. Dave Ricks.
我現在想把會議交給我們的主持人戴夫·里克斯先生。
Please go ahead, sir.
請繼續,先生。
David A. Ricks - Chairman, CEO & President
David A. Ricks - Chairman, CEO & President
Good morning.
早上好。
Thank you for joining us for Eli Lilly and Company's Fourth Quarter 2017 Earnings Call.
感謝您參加禮來公司 2017 年第四季度財報電話會議。
I'm Dave Ricks, Lilly's Chairman and CEO.
我是禮來公司董事長兼首席執行官戴夫·里克斯。
Joining me on today's call are Josh Smiley, our CFO; Dr. Jan Lundberg, President of Lilly Research Labs; Enrique Conterno, President of Lilly Diabetes and Lilly USA; Dr. Sue Mahony, President of Lilly Oncology; Christi Shaw, President of Lilly Bio-Medicines; and Jeff Simmons, President of Our Elanco Animal Health business.
和我一起參加今天電話會議的是我們的首席財務官 Josh Smiley;禮來研究實驗室總裁 Jan Lundberg 博士; Enrique Conterno,禮來糖尿病和禮來美國公司總裁;禮來腫瘤學總裁 Sue Mahony 博士;禮來生物醫藥總裁 Christi Shaw;和我們的 Elanco 動物保健業務總裁 Jeff Simmons。
We're also joined by Kristina Wright, Chris Ogden, Kevin Hern, and Phil Johnson of the IR team.
IR 團隊的 Kristina Wright、Chris Ogden、Kevin Hern 和 Phil Johnson 也加入了我們的行列。
During this call, we anticipate making projections and forward-looking statements based on our current expectations.
在這次電話會議中,我們預計會根據我們目前的預期做出預測和前瞻性陳述。
Our actual results could differ materially due to a number of factors, including those listed on Slide 3 and those outlined in our latest Forms 10-K and 10-Q filed with the SEC.
由於多種因素,我們的實際結果可能存在重大差異,包括幻燈片 3 中列出的因素以及我們向 SEC 提交的最新表格 10-K 和 10-Q 中概述的因素。
The information we provide about our products and pipeline is for the benefit of the investment community only.
我們提供的有關我們的產品和管道的信息僅是為了投資界的利益。
It is not intended to be promotional, and it is not sufficient for prescribing decisions.
它不是為了促銷,也不足以做出處方決定。
We closed 2017 with another strong quarter, delivering 7% revenue growth, 20% operating income growth and important pipeline progress.
我們以另一個強勁的季度結束了 2017 年,實現了 7% 的收入增長、20% 的營業收入增長和重要的管道進展。
Worldwide revenue growth was once again driven by our new pharmaceutical products.
我們的新醫藥產品再次推動了全球收入增長。
In addition, we continue to expand our margins.
此外,我們繼續擴大我們的利潤。
Excluding the effect of FX on international inventories sold, gross margin as a percent of revenue increased by roughly 130 basis points, and total expense as a percent of revenue declined by over 340 basis points to 52.8%.
排除外匯對已售國際庫存的影響,毛利率佔收入的百分比增加了大約 130 個基點,總費用佔收入的百分比下降了 340 個基點以上,降至 52.8%。
We made progress advancing our pipeline.
我們在推進我們的管道方面取得了進展。
The FDA approved and we launched Taltz for active psoriatic arthritis in the U.S. The European Commission approved Taltz for active psoriatic arthritis in the EU.
FDA 批准,我們在美國推出了 Taltz 治療活動性銀屑病關節炎。歐盟委員會批准了 Taltz 在歐盟治療活動性銀屑病關節炎。
And the FDA accepted our submissions for galcanezumab for migraine prevention as well as the resubmission of baricitinib for rheumatoid arthritis.
FDA 接受了我們提交的用於預防偏頭痛的 galcanezumab 以及重新提交用於類風濕性關節炎的 baricitinib。
On the clinical front, we initiated a Phase III clinical program for baricitinib in atopic dermatitis.
在臨床方面,我們啟動了巴瑞替尼治療特應性皮炎的 III 期臨床項目。
We announced that Cyramza did not show an overall survival benefit in first-line gastric cancer, and we initiated clinical work on the Connected Diabetes Ecosystem.
我們宣布 Cyramza 在一線胃癌中沒有顯示出總體生存獲益,並且我們啟動了關聯糖尿病生態系統的臨床工作。
Including in trials, we evaluate our automated insulin delivery system as well as development and clinical work on our connected insulin pen technology.
包括在試驗中,我們評估我們的自動化胰島素輸送系統以及我們連接的胰島素筆技術的開發和臨床工作。
In terms of capital deployment, we announced an 8% increase in the dividend, reflecting our confidence in the continued growth prospects of the company, and we repurchased $100 million of stock.
在資本配置方面,我們宣布將股息增加 8%,反映了我們對公司持續增長前景的信心,我們回購了 1 億美元的股票。
We closed 2017 with strong momentum, and we are well positioned to achieve our strategic deliverables in 2018 and beyond.
我們以強勁的勢頭結束了 2017 年,我們已做好準備在 2018 年及以後實現我們的戰略成果。
Slide 5 contains more details on these events as well as other key events since our October earnings call.
幻燈片 5 包含有關這些事件以及自 10 月財報電話會議以來其他關鍵事件的更多詳細信息。
I would also note that our analysis of strategic alternatives for Elanco is proceeding well.
我還要指出,我們對 Elanco 戰略選擇的分析進展順利。
We're on track to communicate our decision on our Q2 earnings call in July.
我們有望在 7 月的第二季度財報電話會議上傳達我們的決定。
This quarter, we've included a few additional backup slides on Elanco, where you'll see that recent product launches delivered $40 million of revenue in Q4 and $144 million for the year.
本季度,我們在 Elanco 上添加了一些額外的備份幻燈片,您將在其中看到最近的產品發佈在第四季度帶來了 4000 萬美元的收入,全年帶來了 1.44 億美元的收入。
We are proud that in January, a leading industry publication announced that Galliprant, a first-in-class anti-inflammatory treatment for canine osteoarthritis pain, was named 2017's Best Companion Animal Product, and Clynav, a DNA vaccine for Atlantic salmon, took the top honors as the best food animal product.
我們感到自豪的是,1 月份,一家領先的行業出版物宣布,用於犬骨關節炎疼痛的一流抗炎治療藥物 Galliprant 被評為 2017 年最佳伴侶動物產品,大西洋鮭魚 DNA 疫苗 Clynav 獲得了作為最佳食用動物產品的最高榮譽。
New product launch momentum continued as Elanco's R&D organization achieved important milestones in January, with Galliprant receiving EU marketing authorization; and Credelio, which protects dogs against fleas and ticks, receiving approval in the United States as well as Canada.
新產品發布勢頭持續,Elanco 的研發組織在 1 月份取得了重要的里程碑,Galliprant 獲得了歐盟的營銷授權;和 Credelio,它保護狗免受跳蚤和蜱蟲的侵害,在美國和加拿大獲得批准。
We continued to execute on our Elanco business model changes in Q4, including exploring options for the rbST business, exiting select U.S. distribution agreements and taking steps to reduce our manufacturing footprint.
我們在第四季度繼續執行我們的 Elanco 業務模式變更,包括探索 rbST 業務的選項、退出選定的美國分銷協議以及採取措施減少我們的製造足跡。
Finally, the biggest news affecting Lilly since our last call is U.S. tax reform.
最後,自上次電話會議以來影響禮來的最大新聞是美國稅制改革。
We're pleased that Congress and the administration enacted tax reform that places U.S.-based companies on a more level playing field with our foreign-based competitors.
我們很高興國會和政府實施了稅收改革,使美國公司與我們的外國競爭對手處於更公平的競爭環境中。
This reform will allow U.S. companies, like Lilly, to be more competitive in the global race for innovation.
這項改革將使禮來(Lilly)等美國公司在全球創新競賽中更具競爭力。
For U.S.-headquartered multinational companies, this reform does come with an entry cost through the onetime repatriation toll tax.
對於總部位於美國的跨國公司而言,這項改革確實伴隨著一次性遣返通行費的進入成本。
But it's a net positive as it will enable us to access our global cash and will lower our 2018 effective tax rates.
但這是一個淨積極因素,因為它將使我們能夠獲得我們的全球現金,並將降低我們 2018 年的有效稅率。
Now I'll turn the call over to Josh to discuss the impact and implications of U.S. tax reform, review our Q4 and full year results and provide an update on our financial guidance for 2018.
現在我將把電話轉給喬什,討論美國稅制改革的影響和影響,回顧我們的第四季度和全年業績,並提供我們 2018 年財務指導的最新信息。
Joshua L. Smiley - Senior VP & CFO
Joshua L. Smiley - Senior VP & CFO
Thanks, Dave.
謝謝,戴夫。
On Slide 6, we outline the financial impact to Lilly.
在幻燈片 6 中,我們概述了對禮來公司的財務影響。
And as stated in our press release, we recognized an estimated charge of $1.9 billion in the fourth quarter related to U.S. tax reform.
正如我們在新聞稿中所述,我們在第四季度確認了與美國稅制改革相關的估計費用為 19 億美元。
This charge is comprised of the toll tax assessed on overseas cash and earnings, which totaled approximately $3.6 billion, partially offset by the changes in deferred taxes resulted -- resulting from the transition to a U.S. territorial tax system, including the remeasurement of deferred taxes from 35% to 21%.
此項費用包括對海外現金和收益評估的通行稅,總計約 36 億美元,部分被遞延稅的變化所抵消——這是由於向美國領土稅製過渡而產生的,包括從35% 到 21%。
The other financial impact to Lilly is the effect on our ongoing tax rate.
對禮來公司的另一個財務影響是對我們現行稅率的影響。
Based on our initial assessment, we expect U.S. tax reform to lower our 2018 effective tax rate by roughly 350 basis points from our prior guidance of approximately 21.5% to about 18%.
根據我們的初步評估,我們預計美國稅制改革將使我們 2018 年的有效稅率從我們之前的約 21.5% 至約 18% 的指導值降低約 350 個基點。
The effective tax rate for 2018 reflects the benefits of the lower U.S. corporate income tax rate, partially offset by other provisions of the new tax law.
2018 年的有效稅率反映了較低的美國企業所得稅稅率的好處,部分被新稅法的其他規定所抵消。
Our revised 2018 tax rate guidance is subject to change as we further interpret the new law and as subsequent regulations in guidance are issued.
我們修訂的 2018 年稅率指南可能會隨著我們對新法律的進一步解釋以及指南中後續規定的發布而發生變化。
In total, across both our U.S. and international operations, we estimate that we've now utilized more than $9 billion of cash and investments that won't be required for day-to-day operations.
總的來說,在我們的美國和國際業務中,我們估計我們現在已經使用了超過 90 億美元的現金和投資,這些現金和投資不需要日常運營。
Essentially, all of this amount is held in U.S. dollars, and we do not anticipate any issues in obtaining rapid access to these funds.
從本質上講,所有這些金額都以美元持有,我們預計在快速獲得這些資金方面不會有任何問題。
We do not intend to hold this $9 billion in cash and investments for the long term.
我們不打算長期持有這 90 億美元的現金和投資。
Over the course of 2018 and into 2019, we'll deploy this cash thoughtfully across our capital allocation priorities.
在 2018 年和 2019 年期間,我們將在我們的資本分配優先事項中謹慎部署這筆現金。
First, we'll fund our existing marketed products and pipeline, including capital investments, in line with our current strategy.
首先,我們將根據我們當前的戰略為現有的營銷產品和管道提供資金,包括資本投資。
Next, we'll invest in business development to bolster our future growth prospects.
接下來,我們將投資於業務發展,以支持我們未來的增長前景。
And then we'll return cash to shareholders via increases to the dividend and share buybacks.
然後我們將通過增加股息和股票回購向股東返還現金。
While tax reform does provide ready access to additional funds, it does not alter our business development priorities.
雖然稅收改革確實提供了獲得額外資金的現成途徑,但它並沒有改變我們的業務發展重點。
We'll continue to look for opportunities to augment our pipeline and to bolster our commercial presence in core therapeutic areas of diabetes, oncology, immunology, neurodegeneration and pain.
我們將繼續尋找機會來擴大我們的管道並加強我們在糖尿病、腫瘤學、免疫學、神經退行性疾病和疼痛等核心治療領域的商業存在。
This could come via inlicensing or acquisition.
這可以通過許可或收購來實現。
As we've stated previously, much of our efforts will be focused on clinical-stage assets, pre-proof of concept.
正如我們之前所說,我們的大部分工作將集中在臨床階段資產和概念的預驗證上。
Since the new tax legislation in the U.S. reduces our reliance on debt to fund U.S. cash needs, we will adjust our cash and debt levels going forward.
由於美國的新稅法減少了我們對債務來滿足美國現金需求的依賴,因此我們將在未來調整我們的現金和債務水平。
In the near term, we'll use roughly $2 billion of our repatriated cash to reduce our gross debt level.
在短期內,我們將使用大約 20 億美元的匯回現金來降低我們的總債務水平。
Finally, we expect to conduct some level of share repurchases under our existing authorization, which still has $2 billion remaining.
最後,我們預計將在我們現有的授權下進行一定程度的股票回購,該授權仍有 20 億美元。
Hopefully, this gives you a better understanding of the impact of tax reform and how we intend to use our global cash.
希望這能讓您更好地了解稅收改革的影響以及我們打算如何使用我們的全球現金。
Now let's move to our financial results.
現在讓我們來看看我們的財務結果。
Slide 7 summarizes our presentation of GAAP results and non-GAAP measures, while Slide 8 provides a summary of our GAAP results.
幻燈片 7 總結了我們對 GAAP 結果和非 GAAP 措施的介紹,而幻燈片 8 提供了我們的 GAAP 結果的摘要。
I'll focus my comments on our non-GAAP adjusted measures to provide insights into the underlying trends in our business, so please refer to today's press release for a detailed description of the year-on-year changes in our fourth quarter GAAP results.
我將把我的評論集中在我們的非公認會計原則調整措施上,以深入了解我們業務的潛在趨勢,因此請參閱今天的新聞稿,詳細描述我們第四季度公認會計原則結果的同比變化。
Looking at the non-GAAP measures on Slide 9, you'll see the revenue increase of 7% that Dave mentioned earlier.
查看幻燈片 9 上的非 GAAP 指標,您會看到 Dave 之前提到的 7% 的收入增長。
Gross margin as a percent of revenue decreased to 76.5%.
毛利率佔收入的百分比下降至 76.5%。
This decrease was primarily driven by the effect of foreign exchange rates on international inventories sold and product mix, partially offset by manufacturing efficiencies and higher realized prices.
這一下降主要是由於外匯匯率對銷售的國際庫存和產品組合的影響,部分被製造效率和較高的實際價格所抵消。
Excluding the effect of FX on international inventories sold, gross margin as a percent of revenue increased roughly 130 basis points.
排除外匯對國際銷售庫存的影響,毛利率佔收入的百分比增加了大約 130 個基點。
Total operating expense remained essentially flat, with marketing, selling and administrative expense decreasing 1% and R&D expense increasing 2%.
總運營費用基本持平,營銷、銷售和管理費用下降 1%,研發費用增加 2%。
As a percent of revenue, total OpEx declined by over 340 basis points compared to Q4 2016.
與 2016 年第四季度相比,總運營支出佔收入的百分比下降了 340 多個基點。
Other income and expense was income of $55 million this quarter compared to income of $16 million in last year's quarter due primarily to higher net gain on sales of investments.
本季度其他收入和支出為 5500 萬美元,而去年同期為 1600 萬美元,這主要是由於投資銷售的淨收益增加。
Our tax rate was 20.2%, an increase of 230 basis points compared with the same quarter last year, driven primarily by a lower net discrete tax benefit this quarter compared to Q4 2016.
我們的稅率為 20.2%,與去年同期相比增加了 230 個基點,主要是由於本季度與 2016 年第四季度相比淨離散稅收優惠較低。
At the bottom line, net income increased 19%, and earnings per share increased 20%.
最終,淨利潤增長了 19%,每股收益增長了 20%。
We achieved this significant earnings growth by delivering high single-digit revenue growth while significantly reducing our OpEx ratio, creating positive leverage again this quarter.
我們通過實現高個位數的收入增長,同時顯著降低我們的運營支出比率,實現了這一顯著的收益增長,本季度再次創造了正槓桿。
Slide 10 details these same non-GAAP measures for the full year, while Slide 11 provides a reconciliation between reported and non-GAAP EPS.
幻燈片 10 詳細介紹了這些相同的全年非公認會計原則措施,而幻燈片 11 提供了報告和非公認會計原則每股收益之間的對賬。
You'll find additional details on these adjustments on Slides 25 and 26.
您可以在幻燈片 25 和 26 上找到有關這些調整的更多詳細信息。
Moving to Slide 12, let's take a look at the effect of price, rate and volume on revenue growth.
轉到幻燈片 12,讓我們看看價格、費率和數量對收入增長的影響。
The effect of foreign exchange was minimal this quarter.
本季度外彙的影響微乎其微。
Excluding a slight tailwind from FX, our worldwide revenue growth on a performance basis was 6% and was primarily driven by volume growth of 4%.
排除外彙的輕微順風,我們的全球收入增長為 6%,主要是由 4% 的銷量增長推動的。
It's worth noting that in our human pharma business, each major geography drove volume growth again this quarter.
值得注意的是,在我們的人類製藥業務中,每個主要地區都在本季度再次推動了銷量增長。
By geography, you'll notice that U.S. pharma revenue increased 9%, driven by both price and volume.
從地理位置來看,您會注意到美國製藥公司的收入增長了 9%,這得益於價格和數量的推動。
Trulicity, Basaglar and Taltz were the main drivers of this growth, offset partially by the recent losses of exclusivity for Strattera, Effient and Axiron and a decline in volume for Cialis.
Trulicity、Basaglar 和 Taltz 是這一增長的主要驅動力,但被最近 Strattera、Effient 和 Axiron 的排他性喪失以及 Cialis 的銷量下降所部分抵消。
U.S. price growth in the fourth quarter was favorably impacted by an adjustment for rebates and discounts primarily related to lower Medicaid utilization across the portfolio.
美國第四季度的價格增長受到了主要與整個投資組合中醫療補助利用率降低有關的回扣和折扣調整的有利影響。
For U.S. pharma, it's also worth noting that when normalizing for the recent LOEs of Strattera, Effient and Axiron, revenue grew by approximately 20%, driven by our new products.
對於美國製藥公司來說,還值得注意的是,在我們的新產品推動下,在最近的 Strattera、Effient 和 Axiron 的 LOE 正常化時,收入增長了約 20%。
Moving to Europe.
搬到歐洲。
Pharma revenue grew 9% excluding FX, driven entirely by volume, despite the loss of exclusivity for Cialis and headwinds on Alimta due to competitive pressures, pricing and generic erosion in certain countries.
儘管由於某些國家的競爭壓力、定價和仿製藥侵蝕導致 Cialis 失去了排他性以及 Alimta 的不利因素,但不包括外彙在內的製藥收入增長了 9%。
Excluding Cialis and Alimta, the rest of our European pharma revenue grew 22% on a performance basis, driven by our new product launch portfolio: Trulicity, Olumiant, Taltz, Jardiance and Lartruvo.
除 Cialis 和 Alimta 外,我們的其他歐洲製藥收入在業績基礎上增長了 22%,這得益於我們的新產品推出組合:Trulicity、Olumiant、Taltz、Jardiance 和 Lartruvo。
In Japan, despite the entry of generic Zyprexa last June, pharma revenue increased 9% excluding FX, led by Cymbalta, Trulicity and Cyramza.
在日本,儘管去年 6 月仿製藥 Zyprexa 進入,但在 Cymbalta、Trulicity 和 Cyramza 的帶動下,不包括 FX 的製藥收入增長了 9%。
Our pharma revenue in the rest of the world increased 5% on a performance basis this quarter, led by Trulicity, Humalog and Forteo.
本季度,我們在世界其他地區的製藥收入在 Trulicity、Humalog 和 Forteo 的帶動下增長了 5%。
Turning to animal health.
轉向動物健康。
Excluding the impact of FX, worldwide revenue decreased 7% driven by volume.
排除外彙的影響,全球收入因銷量下降 7%。
Food animal revenue declined by 10%, driven primarily by market access headwinds for Posilac and competitive pressures for Optaflexx, while companion animal revenue was essentially flat.
食用動物收入下降了 10%,主要是由於 Posilac 的市場准入逆風和 Optaflexx 的競爭壓力,而伴侶動物收入基本持平。
On a performance basis, excluding the BI U.S. vaccines acquisition, our animal health revenue decreased 11%, with companion animal revenue down 16%, driven primarily by a reduction in U.S. distributor inventory levels as well as competitive pressures in parasiticides.
在業績基礎上,不包括 BI 美國疫苗收購,我們的動物保健收入下降了 11%,伴隨動物收入下降了 16%,這主要是由於美國分銷商庫存水平的下降以及殺蟲劑的競爭壓力。
Slide 13 outlines this same information for our full year results.
幻燈片 13 概述了我們全年業績的相同信息。
Now let's take a look at the drivers of our worldwide volume growth on Slide 14.
現在讓我們在幻燈片 14 上看一下我們全球銷量增長的驅動因素。
In total, our new products, comprised of Trulicity, Taltz, Basaglar, Lartruvo, Jardiance, Cyramza, Olumiant, Verzenio and Portrazza, were the engine of our worldwide volume growth.
總的來說,我們的新產品,包括 Trulicity、Taltz、Basaglar、Lartruvo、Jardiance、Cyramza、Olumiant、Verzenio 和 Portrazza,是我們全球銷量增長的引擎。
You can see that these products drove 12.1 percentage points of volume growth.
您可以看到這些產品推動了 12.1 個百分點的銷量增長。
The loss of exclusivity of Cymbalta, Strattera, Effient, Axiron, Zyprexa and Evista provided a drag of 540 basis points, while Cialis and Animal Health accounted for 170 and 120 basis points of volume decline, respectively.
Cymbalta、Strattera、Effient、Axiron、Zyprexa 和 Evista 排他性的喪失拖累了 540 個基點,而 Cialis 和 Animal Health 分別導致了 170 個和 120 個基點的銷量下降。
Slide 15 provides a view of our new product uptake.
幻燈片 15 提供了我們新產品吸收的視圖。
In total, these brands generated over $1.4 billion in revenue this quarter and represented nearly 23% of our total worldwide revenue, up from 12% in Q4 2016.
這些品牌本季度的總收入超過 14 億美元,占我們全球總收入的近 23%,高於 2016 年第四季度的 12%。
Moving on to Slide 16.
轉到幻燈片 16。
As mentioned earlier, changes in foreign exchange rates had a minimal effect on our Q4 2017 revenue growth.
如前所述,匯率變化對我們 2017 年第四季度的收入增長影響微乎其微。
Similarly, FX had no meaningful impact on our operating expense growth.
同樣,外匯對我們的運營費用增長沒有有意義的影響。
FX did, however, have a large effect on cost of sales growth and, consequently, on operating income and EPS growth.
然而,外匯確實對銷售成本的增長產生了很大的影響,因此對營業收入和每股收益的增長也產生了很大的影響。
For example, growth in non-GAAP EPS was 20%, including the effect of FX.
例如,非 GAAP 每股收益增長 20%,包括外彙的影響。
While it was 32% in constant currency terms, this is largely consistent with the 29% growth for the full year 2017.
雖然按固定匯率計算為 32%,但這與 2017 年全年 29% 的增長基本一致。
Turning to our 2018 financial guidance on Slide 17.
轉向我們關於幻燈片 17 的 2018 年財務指導。
You will see that we've updated our guidance to reflect the estimated impact of U.S. tax reform.
您會看到我們更新了我們的指南,以反映美國稅制改革的估計影響。
This affects our estimated GAAP and non-GAAP tax rates and earnings per share while all other line items remain unchanged.
這會影響我們估計的 GAAP 和非 GAAP 稅率以及每股收益,而所有其他項目保持不變。
Our revised GAAP and non-GAAP 2018 tax rates are both approximately 18%, while our revised GAAP EPS range is $4.39 to $4.49, and our revised non-GAAP EPS range is $4.81 to $4.91.
我們修訂後的 GAAP 和非 GAAP 2018 年稅率均約為 18%,而我們修訂後的 GAAP 每股收益範圍為 4.39 美元至 4.49 美元,我們修訂後的非 GAAP 每股收益範圍為 4.81 美元至 4.91 美元。
I would note the estimated impact of U.S. tax reform on our tax rate and earnings per share guidance is subject to change as we further interpret the new tax law and as subsequent regulations in guidance are issued.
我會注意到美國稅制改革對我們的稅率和每股收益指引的估計影響可能會隨著我們對新稅法的進一步解釋以及隨後的指引規定的發布而發生變化。
Also, in recent weeks, we have seen the dollar weaken substantially.
此外,最近幾週,我們看到美元大幅走軟。
If sustained, this weakness would increase the dollar value of our foreign revenue expenses but, due to the effect of FX on international inventories sold, would likely have only a modest impact on EPS.
如果持續下去,這種疲軟將增加我們海外收入支出的美元價值,但由於外匯對國際銷售庫存的影響,可能只會對每股收益產生適度影響。
We'll monitor FX movements over the course of Q1 and, if appropriate, update our line item guidance on our April call.
我們將在第一季度監控外匯走勢,並在適當的情況下更新我們在 4 月電話會議上的項目指南。
Now I'll turn the call back over to Dave to review the pipeline and key future events.
現在,我將把電話轉回給 Dave,以審查管道和未來的關鍵事件。
David A. Ricks - Chairman, CEO & President
David A. Ricks - Chairman, CEO & President
Thanks, Josh.
謝謝,喬希。
Slide 18 shows select NMEs as of January 24.
幻燈片 18 顯示了截至 1 月 24 日的部分 NME。
Movements since our last earnings call include the initiation of Phase II testing for our D1 potentiator for dementia and our N3pG monoclonal antibody for Alzheimer's disease both as monotherapy as well as in combination with an oral BACE inhibitor.
自我們上次財報電話會議以來的變動包括開始對我們的癡呆症 D1 增強劑和我們的阿爾茨海默病 N3pG 單克隆抗體進行 II 期測試,既可以作為單一療法,也可以與口服 BACE 抑製劑聯合使用。
Phase I starts for an IDO1 inhibitor for cancer and IL-33 for immunology and for the automated insulin system I mentioned earlier, as well as the termination of one Phase I oncology molecule.
第一階段開始用於治療癌症的 IDO1 抑製劑和用於免疫學的 IL-33 和我之前提到的自動化胰島素系統,以及終止一個第一階段腫瘤分子。
Our select NILEX pipeline, shown on Slide 19, reflects the initiation of the Phase III program for baricitinib in atopic dermatitis and also attrition for ramucirumab for first-line gastric cancer and abemaciclib for squamous non-small cell lung cancer.
我們選擇的 NILEX 管道,如幻燈片 19 所示,反映了巴瑞克替尼治療特應性皮炎的 III 期項目的啟動,以及用於一線胃癌的 ramucirumab 和用於鱗狀非小細胞肺癌的 abemaciclib 的減員。
Turning to Slide 20, you can see the considerable progress we made on the key events we had projected for 2017, while Slide 21 highlights our expected key events for 2018, which we covered on our 2018 guidance call in December.
轉到幻燈片 20,您可以看到我們在預測 2017 年的關鍵事件上取得了相當大的進展,而幻燈片 21 突出了我們預期的 2018 年關鍵事件,我們在 12 月的 2018 年指導電話會議中對此進行了介紹。
In addition to noting the approval of Taltz for psoriatic arthritis, you'll see that we've added an event for the expected date of disclosure of the KEYNOTE-189 study based on Merck's recent press release announcing the positive results of the Phase III study for Alimta in combination with Keytruda.
除了注意到 Taltz 獲批治療銀屑病關節炎外,您還會看到,根據默克公司最近宣布 III 期研究陽性結果的新聞稿,我們在 KEYNOTE-189 研究的預期披露日期添加了一個事件用於 Alimta 與 Keytruda 的組合。
2018 will be an important year, with potential Phase III initiations and data readouts for several promising new molecules and line extensions, as well as we expect regulatory actions for galcanezumab, baricitinib and abemaciclib.
2018 年將是重要的一年,幾個有希望的新分子和產品線擴展可能會啟動 III 期臨床試驗和數據讀出,以及我們預計對 galcanezumab、baricitinib 和 abemaciclib 的監管行動。
Before we go to the Q&A session, let me briefly sum up the progress we made in 2017 and our priorities moving forward.
在進入問答環節之前,讓我簡要總結一下我們在 2017 年取得的進展以及我們未來的工作重點。
In 2017, new products delivered nearly 20% of our total revenue, up from just 9% in 2016.
2017 年,新產品貢獻了我們總收入的近 20%,高於 2016 年的 9%。
Our growing portfolio of new medicines drove strong 8% top line growth for the full year.
我們不斷增長的新藥組合推動了全年 8% 的強勁收入增長。
We achieved this result while maintaining relatively flat operating expenses, driving operating margin improvement of more than 450 basis points, excluding FX.
我們在保持相對平穩的運營費用的同時實現了這一結果,推動運營利潤率提高了 450 多個基點,不包括外匯。
We are in the early stages of a growth period, driven by revenue from our recently launched products.
在我們最近推出的產品收入的推動下,我們處於增長期的早期階段。
The potential of our pipeline remains strong, with new medicines in development for immunology, oncology, diabetes and neurodegeneration, complemented by a deep, late-stage pain portfolio as well as additional indications for many recently launched products.
我們的產品線潛力依然強勁,免疫學、腫瘤學、糖尿病和神經退行性疾病的新藥正在開發中,並輔以深入的晚期疼痛產品組合以及許多最近推出的產品的額外適應症。
Moving into 2018, we remain focused on launching with excellence and replenishing our pipeline while continuing to deliver bottom line growth and operating margin improvement.
進入 2018 年,我們將繼續專注於推出卓越產品並補充我們的管道,同時繼續實現底線增長和運營利潤率改善。
This concludes our prepared remarks.
我們準備好的評論到此結束。
Now I'll turn the call over to Phil Johnson to moderate the Q&A session.
現在我將把電話轉給 Phil Johnson 來主持問答環節。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Great.
偉大的。
Thank you, Dave.
謝謝你,戴夫。
(Operator Instructions) Kingsom, if you could please provide the instructions for the Q&A session, and now we're ready to get started.
(操作員說明)Kingsom,如果可以的話,請提供問答環節的說明,現在我們已經準備好開始了。
Operator
Operator
(Operator Instructions) We will go to Steve Scala with Cowen.
(操作員說明)我們將與 Cowen 一起前往 Steve Scala。
Stephen Michael Scala - MD and Senior Research Analyst
Stephen Michael Scala - MD and Senior Research Analyst
Two questions.
兩個問題。
Do you anticipate an FDA AdCom for baricitinib by, say, midyear?
您是否預計會在年中之前推出針對巴瑞替尼的 FDA AdCom?
And can you give us reassurance that there is not any safety issue beyond DVT that will be a subject of discussion?
您能否向我們保證,除了 DVT 之外沒有任何安全問題將成為討論的主題嗎?
So that's the first question.
所以這是第一個問題。
Second one is, over the last, say, 2 to 3 decades, Lilly always had 1 to 2 big-potential products in the pipeline that investors could focus on.
第二個是,在過去的 2 到 3 年裡,禮來公司總是有 1 到 2 種潛力巨大的產品可供投資者關注。
This would appear less a dimension of Lilly today.
這在今天似乎不再是禮來的一個維度。
You probably disagree, so please tell us what billion dollar-plus opportunities you have in the mid-stage pipeline, so not including lanabecestat, galcanezumab, tanezumab or lasmiditan.
您可能不同意,所以請告訴我們您在中期管道中有哪些十億美元以上的機會,因此不包括 lanabecestat、galcanezumab、tanezumab 或 lasmiditan。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Great, Steve.
太好了,史蒂夫。
Thank you for the questions.
謝謝你的提問。
So Christi, if you'll take the question on whether or not we'd expect an FDA AdCom for baricitinib and if there are additional safety issues beyond DVT that we think might be addressed should such an AdCom be held.
所以克里斯蒂,如果你想問一下我們是否期待 FDA 對巴瑞替尼的 AdCom,以及我們認為如果舉行這樣的 AdCom 可能會解決 DVT 之外的其他安全問題。
And then maybe Dave and Jan, if you'd like to comment on mid-stage pipeline assets that you are excited about.
然後也許是 Dave 和 Jan,如果您想對您感興趣的中期管道資產發表評論。
Christi?
克里斯蒂?
Christi Shaw - SVP and President of Lilly Bio-Medicines
Christi Shaw - SVP and President of Lilly Bio-Medicines
Sure, hi Steve.
當然,嗨史蒂夫。
As we said before, we do expect the FDA to have an Advisory Committee, but the timing of that is up to the FDA, and they'll make that publicly known.
正如我們之前所說,我們確實希望 FDA 有一個諮詢委員會,但具體時間取決於 FDA,他們會公開這一點。
We won't be commenting on a date before they do.
我們不會在他們之前評論日期。
And in terms of other safety, we really don't anticipate other major safety questions and issues in regard to the AdCom and the resubmission.
在其他安全方面,我們真的沒有預料到與 AdCom 和重新提交有關的其他重大安全問題和問題。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Great.
偉大的。
Thank you, Christi.
謝謝你,克里斯蒂。
Dave, Jan?
戴夫,簡?
David A. Ricks - Chairman, CEO & President
David A. Ricks - Chairman, CEO & President
Jan, do you want to start?
簡,你要開始嗎?
Jan M. Lundberg - Executive VP of Science & Technology and President of Lilly Research Laboratories
Jan M. Lundberg - Executive VP of Science & Technology and President of Lilly Research Laboratories
Okay, I can start.
好的,我可以開始了。
Let us first look at the 2 new Phase II programs that we see, being -- clearly, we are dependent on more clinical data, but we already have some clinical data from Phase Ib in both the D1 potentiator for dementia, which is an interesting molecule that could enhance then cognition but potentially also somnolence and, in Parkinson's disease, also motor function.
讓我們首先看看我們看到的 2 個新的 II 期項目,很明顯,我們依賴於更多的臨床數據,但我們已經在 D1 癡呆增強劑中獲得了 Ib 期的一些臨床數據,這是一個有趣的這種分子可以增強認知,但也可能增強嗜睡,在帕金森病中,還可以增強運動功能。
The N3pG program is, as you probably remember, a plaque-removing antibody.
您可能還記得,N3pG 程序是一種去除斑塊的抗體。
And we have optimized the dosing regimen since it has some immunogenicity, and we are putting that now into larger Phase II trials.
我們已經優化了給藥方案,因為它具有一定的免疫原性,我們現在正在將其投入到更大的 II 期試驗中。
And we are combining it also with an oral BACE inhibitor, which we know that will shut off the production of amyloid beta.
我們還將它與一種口服 BACE 抑製劑結合使用,我們知道這將關閉β澱粉樣蛋白的產生。
In fact, now in Alzheimer's, we are trying to get positive data, if at all, that are then doable in Phase II in hundreds of patients, not in thousands of patients in Phase III, and we are addressing early disease.
事實上,現在在阿爾茨海默氏症中,我們正在努力獲得積極的數據,如果有的話,這些數據在 II 期的數百名患者中是可行的,而不是在 III 期的數千名患者中,我們正在解決早期疾病。
We really want to have a more homogeneous patient population, which has been one of the problems.
我們真的希望有一個更加同質的患者群體,這一直是問題之一。
And we are using our imaging tools both for amyloid and tau to make that happen.
我們正在使用我們的澱粉樣蛋白和 tau 成像工具來實現這一目標。
And we are also trying then to hit the target in a maximal way by not only removing amyloid but stopping the production.
我們還試圖通過不僅去除澱粉樣蛋白而且停止生產以最大限度地達到目標。
The other agent I want to emphasize is a potential agent with more powerful body weight-lowering effects than the current GLP-1, and that is the GIP/GLP-1 co-agonist.
我要強調的另一種藥劑是一種比目前的 GLP-1 具有更強大的減肥效果的潛在藥劑,那就是 GIP/GLP-1 共激動劑。
And we have seen some interesting data in Phase I in healthy volunteers, and now we want to see them in a larger Phase II study, how much can this actually reduce body weight and, at the same time, have a powerful blood glucose-lowering effect.
我們已經在健康志願者的第一階段看到了一些有趣的數據,現在我們想在更大的第二階段研究中看到它們,這實際上可以減輕多少體重,同時具有強大的降血糖作用影響。
I also believe that our IL-23 molecule, mirikizumab, has a variety of options for immunological indications, including then IBD, ulcerative colitis where we have potential to be first-in-class, but it's also an interesting option for psoriasis and potentially other indications.
我還相信我們的 IL-23 分子 mirikizumab 有多種免疫適應症選擇,包括 IBD、潰瘍性結腸炎,我們有可能成為一流,但它也是銀屑病和其他潛在疾病的有趣選擇適應症。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Okay.
好的。
Do you have anything to add?
你有什麼要補充的嗎?
Or are you...
還是你...
David A. Ricks - Chairman, CEO & President
David A. Ricks - Chairman, CEO & President
I don't.
我不。
It's exactly what I would have said.
這正是我會說的。
Thank you.
謝謝你。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Excellent.
出色的。
Thank you.
謝謝你。
Operator
Operator
We'll go to the line of Andrew Baum with Citi.
我們將與花旗一起前往安德魯鮑姆的路線。
Andrew Simon Baum - Global Head of Healthcare Research and MD
Andrew Simon Baum - Global Head of Healthcare Research and MD
A couple of questions.
幾個問題。
First, for, I guess, Enrique and Sue.
首先,我猜是為了恩里克和蘇。
Since your ascension to CEO, Dave, we've been expecting a external move on oncology given Levi is joining the company.
自從您升任首席執行官 Dave 以來,鑑於 Levi 將加入公司,我們一直期待在腫瘤學方面採取外部行動。
There has been more deals but nothing substantive.
有更多的交易,但沒有實質性的。
Were we wrong to assume that there was an intent to commit capital and balance sheet to accelerating your rebuild in oncology particularly in IO?
我們是否有錯誤地假設有意投入資金和資產負債表來加速您在腫瘤學領域的重建,尤其是在 IO 領域?
Or if you could just share with us what are the barriers, be it valuation or other, which may have delayed such activity?
或者,如果您可以與我們分享一下可能推遲此類活動的障礙是什麼,無論是估值還是其他?
That's the first question.
這是第一個問題。
Second question for Enrique.
恩里克的第二個問題。
We have expressed a fair degree of excitement on the commercial potential of the SGLT2 class, including Jardiance.
我們對包括 Jardiance 在內的 SGLT2 類的商業潛力表達了相當程度的興奮。
Perhaps you could give us your perception of where the class could go and what are the barriers to overcome and what catalysts we should be attuned to, pending cardiovascular clinical trial data, diminishing safety concerns and other, in order to get us there?
也許您可以告訴我們您對課程可以去哪里以及需要克服哪些障礙以及我們應該適應哪些催化劑、等待心血管臨床試驗數據、減少安全問題等方面的看法,以便讓我們到達那裡?
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Great.
偉大的。
Andrew, thank you for the questions.
安德魯,謝謝你的問題。
Dave, if you'd like to comment on the external business development strategy for our oncology franchise, and then, Enrique, the question on the potential going forward for the SGLT2 class.
戴夫,如果您想對我們的腫瘤專營權的外部業務發展戰略發表評論,然後,恩里克,關於 SGLT2 課程未來發展潛力的問題。
Dave?
戴夫?
David A. Ricks - Chairman, CEO & President
David A. Ricks - Chairman, CEO & President
Sure.
當然。
Well, I guess at a top level, Andrew, I would say your assumptions about our ambition to use balance sheet capacity as well as income statement capacity to grow our Oncology business aren't wrong.
好吧,我想在高層,安德魯,我會說你對我們利用資產負債表能力和損益表能力來發展我們的腫瘤業務的雄心的假設沒有錯。
We very much plan to do that.
我們非常計劃這樣做。
We're adding talent, as you noted, and we are looking at many, many opportunities there.
正如你所說,我們正在增加人才,我們正在尋找很多很多的機會。
Of course, we're bounded by pricing and value, which is something we're committed to make sure we're not doing deals just to fill strategic holes in the pipeline but they make sense for our investors over the long term.
當然,我們受到定價和價值的限制,這是我們致力於確保我們不只是為了填補管道中的戰略漏洞而進行的交易,但從長遠來看,它們對我們的投資者有意義。
And I think we also want to think carefully about our strategy in oncology, what can complement existing assets and add to what we're doing versus just de novo efforts to enter a space.
而且我認為我們還想仔細考慮我們在腫瘤學方面的戰略,什麼可以補充現有資產並增加我們正在做的事情,而不是從頭開始進入一個領域。
So given the price points in oncology, we're careful about our work, but I think it would be reasonable to expect a busy year in business development for oncology for Lilly.
因此,鑑於腫瘤學的價格點,我們對我們的工作很謹慎,但我認為期待禮來(Lilly)在腫瘤學業務發展中忙碌的一年是合理的。
Whether those translate into deals, that's a competitive process, we'll work through that, but I don't think directionally, your assumptions are wrong.
無論這些轉化為交易,這是一個競爭過程,我們都會解決這個問題,但我不認為有方向性,你的假設是錯誤的。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Thanks, Dave.
謝謝,戴夫。
Enrique?
恩里克?
Enrique A. Conterno - SVP, President of Lilly Diabetes and President of Lilly USA
Enrique A. Conterno - SVP, President of Lilly Diabetes and President of Lilly USA
Sure.
當然。
So I continue to be quite bullish on Jardiance, and I think the frame should be much more Jardiance than the SGLT2 class.
所以我繼續看好Jardiance,我認為框架應該比SGLT2類更Jardiance。
When we look at the SGLT2 class, we do see a number of headwinds, in particular because of the updated label for INVOKANA.
當我們查看 SGLT2 類時,我們確實看到了一些不利因素,特別是因為 INVOKANA 的標籤更新。
And that has been a headwind for the class, but we need to look at Jardiance's growth and overall progression when we look at its use as a much better predictor for that to be a catalyst for the overall SGLT2 class.
這對班級來說是一個不利因素,但是當我們將 Jardiance 的使用作為更好的預測指標來作為整個 SGLT2 班級的催化劑時,我們需要看看 Jardiance 的增長和整體進展。
Clearly, we are focused today on type 2 diabetes, but we do have trials for heart failure and chronic kidney disease.
顯然,我們今天專注於 2 型糖尿病,但我們確實有針對心力衰竭和慢性腎病的試驗。
When it comes to type 2 diabetes, some of the challenges that we had have been some of those headwinds that I just referred to for what was the leader of the class.
當談到 2 型糖尿病時,我們所面臨的一些挑戰是我剛才提到的一些不利因素,因為它是班級的佼佼者。
We do like the fact that there's going to be increased promotion by having some additional competitors enter the class.
我們確實喜歡這樣一個事實,即通過讓一些額外的競爭對手進入班級來增加促銷活動。
I think this direction is going to be helpful to Jardiance.
我認為這個方向將對 Jardiance 有所幫助。
And finally, it's just been able to make cardio protection a much higher priority for all of -- for all physicians beyond A1c when they're thinking about patients with type 2 diabetes.
最後,當考慮到 2 型糖尿病患者時,它只是能夠使心臟保護成為所有人的優先事項——對於除 A1c 之外的所有醫生。
So we are encouraged by the progress that we continue to see, but much more progress is needed.
因此,我們對我們繼續看到的進展感到鼓舞,但還需要更多的進展。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Great.
偉大的。
Thank you, Enrique.
謝謝你,恩里克。
Operator
Operator
And next, we'll go to the line of Seamus Fernandez with Leerink.
接下來,我們將與 Leerink 一起前往 Seamus Fernandez 的路線。
Seamus Christopher Fernandez - MD, Major Pharmaceuticals and Biotechnology
Seamus Christopher Fernandez - MD, Major Pharmaceuticals and Biotechnology
So just a couple of quick ones.
所以只是幾個快速的。
First off, can you guys -- I guess I'm a little confused by the capital allocation discussion, so I guess I'll ask this one in 2 parts.
首先,你們能不能——我想我對資本分配的討論有點困惑,所以我想我會分兩部分問這個問題。
You guys are reducing your debt to the tune of $2 billion, and yet it would seem like -- maybe you can just explain the capital allocation decision there and the need to reduce the debt given your net cash position.
你們正在將債務減少到 20 億美元,但看起來 - 也許你可以解釋那裡的資本分配決定以及鑑於你的淨現金頭寸減少債務的必要性。
So it's a little bit confusing in that regard if you're moving forward with other potential deal considerations.
因此,如果您正在推進其他潛在的交易考慮因素,這在這方面會有點令人困惑。
So I'm just trying to get a sense of the discipline there.
所以我只是想了解那裡的紀律。
And the second part of that same question is, has the board already reviewed the capital allocation dynamics and decision points?
同一個問題的第二部分是,董事會是否已經審查了資本配置動態和決策點?
Or is that coming on a go-forward basis in the wake of tax reform?
還是在稅制改革之後向前推進?
So you can move on debt immediately, but other capital allocation decisions and priorities are under review.
因此,您可以立即轉移債務,但其他資本分配決策和優先事項正在審查中。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Great.
偉大的。
Seamus, thank you for the questions.
Seamus,謝謝你的提問。
On capital allocation, Josh, it is right up your alley.
在資本配置方面,喬希,這正合你的胃口。
Joshua L. Smiley - Senior VP & CFO
Joshua L. Smiley - Senior VP & CFO
Okay.
好的。
Thanks, Seamus.
謝謝,西莫。
First, as it relates to our overall position, we're in a very slight net cash position right now.
首先,由於它與我們的整體頭寸有關,我們現在的淨現金頭寸非常少。
But as I mentioned in the comments, we're going to work that down over time.
但正如我在評論中提到的,隨著時間的推移,我們將努力解決這個問題。
So we expect over time to be in a net debt position for sure.
因此,我們預計隨著時間的推移肯定會處於淨債務狀態。
I think as it relates specifically to the $2 billion, we have about $13.5 billion of debt, and to work that down by $2 billion is really to get at our target of 2.5x EBITDA for our leverage ratio.
我認為,由於它與 20 億美元特別相關,我們有大約 135 億美元的債務,而將其減少 20 億美元實際上是為了實現我們的槓桿比率 2.5 倍 EBITDA 的目標。
Now that's just -- the reason we do that, Seamus, is really just to give us the capacity to make investments when we see shareholder value opportunities -- [at least] opportunities ahead of us.
現在這只是 - 我們這樣做的原因,Seamus,實際上只是為了讓我們有能力在我們看到股東價值機會時進行投資 - [至少] 機會擺在我們面前。
So of course, last year, we've raised -- without the new tax reform legislation, we raised debt in the U.S. and actually increased it.
因此,當然,去年,我們已經籌集了 - 在沒有新的稅收改革立法的情況下,我們在美國籌集了債務並實際上增加了它。
So now what we'll do here is to try to get back to our 2.5 leverage ratio.
所以現在我們要做的是嘗試回到我們的 2.5 槓桿比率。
And again, that's not a long-term target; that's just where we'd like to start.
再說一次,這不是一個長期目標。這正是我們想要開始的地方。
And then to your question about the board, I mean, we have -- we've been very clear, I think, for the last few years about our capital allocation priorities.
然後關於你關於董事會的問題,我的意思是,我們已經 - 我認為,在過去的幾年裡,我們一直非常清楚我們的資本分配優先事項。
And as I mentioned, we have $9 billion of cash.
正如我提到的,我們有 90 億美元的現金。
We now have free access to it that we didn't in the past.
我們現在可以免費訪問它,這是我們過去沒有的。
And we'll work through that cash on a pretty methodical basis.
我們將有條不紊地處理這筆現金。
And you should expect to see, again, investments in the business, you should expect to see business development, as Dave mentioned, and you will see dividend increases and share buybacks over time.
正如戴夫所說,您應該再次看到對業務的投資,您應該期待看到業務發展,並且隨著時間的推移,您將看到股息增加和股票回購。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Great.
偉大的。
Thanks, Josh.
謝謝,喬希。
Operator
Operator
And we'll go to the line of John Boris with SunTrust.
我們將與 SunTrust 一起前往 John Boris 的路線。
John Thomas Boris - MD
John Thomas Boris - MD
First question on diabetes.
關於糖尿病的第一個問題。
Sequentially, it seems as though there was a higher degree of discounting, rebating going on, so some noise there.
隨後,似乎有更高程度的折扣,回扣正在進行,所以那裡有些噪音。
Can you maybe just give us some insights into that?
你能給我們一些見解嗎?
And then a question for you, Dave.
然後問你一個問題,戴夫。
I think Lilly has a self-insurance model with some pretty high drug utilization.
我認為禮來公司有一個自我保險模式,藥物利用率相當高。
How do you anticipate -- at least from your experience of having a self-insurance model, how do you anticipate the administration is going to go about lowering drug pricing?
您如何預測——至少從您擁有自我保險模式的經驗來看,您預計政府將如何降低藥品定價?
Certainly, seems as though there's a lot of value trapped within the system in discounts and rebates, but how would you go about unleashing some of that and getting it back into the hands of employer groups and, more importantly, into patients?
當然,在折扣和回扣中似乎有很多價值被困在系統中,但您將如何釋放其中的一些並將其重新交到雇主團體手中,更重要的是,回到患者手中?
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Great.
偉大的。
John, thank you for the questions.
約翰,謝謝你的提問。
So Enrique, if you'll comment on insights into what's going on with diabetes rebating here in the U.S., and then Dave obviously to talk about some of the drug pricing dynamics and how that might be addressed going forward.
因此,Enrique,如果您對美國糖尿病退稅的情況發表評論,然後 Dave 顯然會談論一些藥物定價動態以及未來如何解決這些問題。
Enrique?
恩里克?
Enrique A. Conterno - SVP, President of Lilly Diabetes and President of Lilly USA
Enrique A. Conterno - SVP, President of Lilly Diabetes and President of Lilly USA
Yes.
是的。
So we continue to see pressure on pricing across all of our diabetes products.
因此,我們繼續看到我們所有糖尿病產品的定價壓力。
When we look at our Q4 results, I think there was pressure from a rebating perspective on the insulin portfolio, so both Humalog and Basaglar in particular.
當我們查看第四季度的結果時,我認為從回扣的角度來看,胰島素組合存在壓力,尤其是 Humalog 和 Basaglar。
But we are being extremely disciplined, and we like our overall prospects and the access that we basically have with all of our top brands.
但是我們非常自律,我們喜歡我們的整體前景以及我們基本上擁有的所有頂級品牌的訪問權限。
We believe that Trulicity, for example, is extremely well positioned for '18, and so is Jardiance.
例如,我們認為 Trulicity 非常適合 18 年,Jardiance 也是如此。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Great.
偉大的。
Thank you, Enrique.
謝謝你,恩里克。
Dave?
戴夫?
David A. Ricks - Chairman, CEO & President
David A. Ricks - Chairman, CEO & President
Yes.
是的。
Thanks, John.
謝謝,約翰。
Well, I think you're right to point out what's the connection between Lilly's actions as a provider of health care benefits to employees as well as our policy positions.
好吧,我認為你指出禮來作為員工醫療福利提供者的行為與我們的政策立場之間的聯繫是正確的。
We try to make them as similar as we can.
我們試圖使它們盡可能相似。
Of course, we do self-insure, we own a financial risk for our beneficiaries in our programs.
當然,我們進行自我保險,我們為我們計劃中的受益人承擔財務風險。
And I think there's 2 things that we do that I think stand out from the market.
我認為我們做的有兩件事我認為在市場上脫穎而出。
One is we have no bias in our health insurance programs for our employees toward medications, whereas in the general marketplace, on average, patients pay 4x out of pocket for medications and other health services.
一是我們的員工健康保險計劃對藥物沒有偏見,而在一般市場上,患者平均為藥物和其他健康服務支付 4 倍的自付費用。
So we think that bias should go away, that you could actually make a good argument that medications have a bias for them because of the efficiency of prescription drugs versus other parts of the health care system, but we've eliminated that.
所以我們認為偏見應該消失,你實際上可以提出一個很好的論點,即由於處方藥相對於醫療保健系統的其他部分的效率,藥物對它們有偏見,但我們已經消除了這一點。
The other thing which is new for us is rebate pass-through.
對我們來說另一件新鮮事是回扣傳遞。
We've executed for our employee population the pass-through rebate program.
我們已經為我們的員工群體執行了直通返利計劃。
We are calling for that through pharma and directly from the government because CMS has a unique role as the market maker here, in particular in the Part D program.
我們通過製藥公司和政府直接呼籲這樣做,因為 CMS 在這裡作為做市商具有獨特的作用,特別是在 D 部分計劃中。
So we would like to see rebate pass-through for Part D beneficiaries.
因此,我們希望看到 D 部分受益人的回扣傳遞。
As you know, the rebate levels probably across all of pharma are something like 30% to 40%.
如您所知,所有製藥公司的回扣水平可能在 30% 到 40% 左右。
That could have an immediate and very positive impact on seniors who are struggling to cover their doughnut hole-exposed prescriptions.
這可能會對那些努力支付甜甜圈洞暴露處方的老年人產生直接和非常積極的影響。
And we think this is a good idea that the administration should act on immediately.
我們認為這是一個好主意,政府應該立即採取行動。
I would expect a busy year regulatory-wise.
我預計在監管方面會是忙碌的一年。
In Washington, as they look to introduce market mechanisms and lower costs of the pharmacy counter for patients and work for both of those things, we'll partner closely with the administration to try to make positive progress in a pro-innovation way that actually affects patients' pocketbooks.
在華盛頓,當他們希望為患者引入市場機制和降低藥房櫃檯的成本並為這兩件事努力時,我們將與政府密切合作,嘗試以支持創新的方式取得積極進展,從而實際影響病人的錢包。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Thanks, Dave.
謝謝,戴夫。
Operator
Operator
And we'll go to the line of Tim Anderson with Bernstein.
我們將與伯恩斯坦一起前往蒂姆安德森的路線。
Timothy Minton Anderson - Senior Analyst
Timothy Minton Anderson - Senior Analyst
A couple of questions.
幾個問題。
An occasional bear case with Trulicity has been your REWIND cardiovascular outcomes trial, and then it's higher risk because it studies the healthier population, so the bar that's showing a benefit could in principle be higher.
Trulicity 的一個偶然案例是您的 REWIND 心血管結果試驗,然後它的風險更高,因為它研究的是更健康的人群,所以原則上顯示益處的標準可能更高。
Can we play out the scenario whereby this trial does indeed fail to show a benefit in 2018?
我們能否演練這種試驗在 2018 年確實未能顯示出益處的情景?
In your view, would that have a materially negative impact on the commercial future of Trulicity, either in U.S. or Europe?
在您看來,這會對 Trulicity 在美國或歐洲的商業未來產生重大負面影響嗎?
And if not, why not?
如果沒有,為什麼不呢?
And then the second question is on oral GLP-1.
然後第二個問題是關於口服 GLP-1。
Your program and your initiatives are much earlier than Novo's.
您的計劃和倡議比 Novo 的要早得多。
It is nearing the conclusion of multiple Phase III trials.
它已接近多項 III 期試驗的結束。
I'm wondering why there's such a disparity in time lines.
我想知道為什麼時間線會有如此大的差異。
Does Novo have a unique technology that Lilly's had difficulty replicating?
Novo 是否擁有禮來難以復制的獨特技術?
Or what's the reason exactly?
或者俱體是什麼原因?
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Great.
偉大的。
Tim, thank you for the questions.
蒂姆,謝謝你的提問。
So for you, Enrique, on potential impacts should REWIND be negative and then our efforts on oral GLP-1 and the timing of those.
因此,Enrique 對您來說,潛在影響應該是負面的,然後是我們在口服 GLP-1 上的努力以及時間安排。
Enrique A. Conterno - SVP, President of Lilly Diabetes and President of Lilly USA
Enrique A. Conterno - SVP, President of Lilly Diabetes and President of Lilly USA
Yes.
是的。
So clearly, there are a number of cardiovascular trials that are reading out this year, REWIND, but also, we have trials for linagliptin in CAROLINA and CARMELINA that are reading out.
很明顯,今年有許多心血管試驗正在宣讀,REWIND,而且,我們在 CAROLINA 和 CARMELINA 的利格列汀試驗正在宣讀。
Lilly has quite a bit of experience when it comes to designing cardiovascular trials in the diabetes space.
Lilly 在設計糖尿病領域的心血管試驗方面擁有豐富的經驗。
So we feel good about how we designed the trial, and we are -- continue to be optimistic about our result.
所以我們對我們如何設計試驗感覺很好,而且我們 - 繼續對我們的結果持樂觀態度。
I really don't want to speculate about what a negative trial would be.
我真的不想推測負面試驗會是什麼。
That's clearly not where our case is.
這顯然不是我們的情況。
Clearly, as we think about future diabetes therapies, having a cardiovascular outcome benefit is going to be increasingly important.
顯然,當我們考慮未來的糖尿病治療時,對心血管結果的益處將變得越來越重要。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
And on the oral GLP-1?
在口服 GLP-1 上呢?
Enrique A. Conterno - SVP, President of Lilly Diabetes and President of Lilly USA
Enrique A. Conterno - SVP, President of Lilly Diabetes and President of Lilly USA
So we are highly interested in this space and working on pursuing oral GLP-1s.
所以我們對這個領域非常感興趣,並致力於追求口服 GLP-1。
And as we think about progressing to the clinical phase, I think the hurdle that we basically have is one of getting the right bioavailability for our product in order to make sure that we can make this commercially successful on a worldwide basis.
當我們考慮進入臨床階段時,我認為我們基本上面臨的障礙之一是為我們的產品獲得正確的生物利用度,以確保我們能夠在全球範圍內取得商業上的成功。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Great.
偉大的。
Did you want to add anything, Jan?
你想添加什麼嗎,簡?
Or...
或者...
Jan M. Lundberg - Executive VP of Science & Technology and President of Lilly Research Laboratories
Jan M. Lundberg - Executive VP of Science & Technology and President of Lilly Research Laboratories
Yes.
是的。
If we look at a high level, the oral absorptions of peptides is hindered by a lot of natural mechanism.
如果我們從高水平來看,肽的口服吸收受到許多自然機制的阻礙。
And we assume that the Novo product only has 1% or 2% bioavailability, which means that you lose most of this substance then.
我們假設 Novo 產品只有 1% 或 2% 的生物利用度,這意味著您會失去大部分這種物質。
And the dilemma also remains here about the need for having fasting and not eating for some time after you take this drug because then you have food interaction.
並且在服用這種藥物後一段時間內需要禁食和不進食的問題也仍然存在,因為那時你會發生食物相互作用。
So it's really a suboptimal oral agent, and I think it would be so much better to have a more traditional small molecule for this receptor.
所以它確實是一種次優的口服藥物,我認為為這種受體提供更傳統的小分子會好得多。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Thank you, Jan.
謝謝你,簡。
Operator
Operator
We'll go to the line of Jami Rubin with Goldman Sachs.
我們將與高盛一起前往 Jami Rubin。
Jamilu E. Rubin - Equity Analyst
Jamilu E. Rubin - Equity Analyst
Just staying along the lines of Trulicity and potential changes to that market, obviously, Ozempic will be launched very shortly if it hasn't already.
顯然,只要遵循 Trulicity 和該市場的潛在變化,Ozempic 將很快推出,如果它還沒有推出的話。
What sort of changes do you expect to Trulicity's market share as a result of Ozempic, plus the fact that Victoza now has a CV claim as well?
由於 Ozempic 以及 Victoza 現在也擁有 CV 聲明這一事實,您預計 Trulicity 的市場份額會發生什麼樣的變化?
And then you touched upon your oral GLP-1, but obviously, we know we're going to see a lot of oral semaglutide trials read out in 2018.
然後您談到了您的口服 GLP-1,但顯然,我們知道我們將在 2018 年看到大量口服 semaglutide 試驗。
And while there are concerns about the food effects and nausea, if the oral sema data are successful and essentially replicate Phase II, what impact, if any, do you see oral sema having on your overall diabetes franchise, including GLP-1s?
儘管人們擔心食物影響和噁心,但如果口服 sema 數據成功並基本上複製了 II 期,那麼您認為口服 sema 對您的整體糖尿病特許經營有什麼影響(如果有的話),包括 GLP-1s?
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Thanks for the questions, Jami.
謝謝你的問題,傑米。
So back to you, Enrique, on Trulicity impact that you might expect from Ozempic and the Victoza CV label update and then thoughts on the potential impact to our franchises if oral semaglutide is successful in Phase III.
因此,Enrique,關於您可能期望從 Ozempic 和 Victoza CV 標籤更新中獲得的 Trulicity 影響,然後再考慮如果口服 semaglutide 在 III 期成功,對我們的特許經營權的潛在影響。
Enrique A. Conterno - SVP, President of Lilly Diabetes and President of Lilly USA
Enrique A. Conterno - SVP, President of Lilly Diabetes and President of Lilly USA
Yes.
是的。
So we continue to be very pleased with the performance of Trulicity.
因此,我們繼續對 Trulicity 的表現感到非常滿意。
Trulicity had significant sequential quarter-on-quarter growth.
Trulicity 有顯著的環比環比增長。
Our market share for the last week is now over 40% for the first time, so we've seen continued gains in overall share despite the fact that, yes, Victoza has an indication for a benefit when it comes to CV events.
我們上週的市場份額現在首次超過 40%,因此我們看到總體份額持續增長,儘管事實上,是的,Victoza 有跡象表明在 CV 事件方面有好處。
One of the big premises that we think about is really how underutilized the GLP-1 class is today.
我們考慮的一個重要前提是今天 GLP-1 類的利用程度如何。
When we look at in the U.S., for example, GLP-1s are about 30% of the basal insulin utilization.
例如,當我們在美國觀察時,GLP-1 約占基礎胰島素利用率的 30%。
So we think there's huge room for expansion, and we believe that Trulicity is going to benefit from that.
所以我們認為有巨大的擴張空間,我們相信 Trulicity 將從中受益。
We are extremely well prepared for semaglutide's launch.
我們為 semaglutide 的上市做好了充分的準備。
I feel good about the experience that we're providing patients.
我對我們為患者提供的體驗感覺良好。
We believe that experience will be unmatched, so we do think that we will be able to compete very effectively.
我們相信經驗將是無與倫比的,因此我們確實認為我們將能夠非常有效地競爭。
We don't provide any type of share forecasts for any of our products.
我們不對我們的任何產品提供任何類型的份額預測。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
And in terms of the oral semaglutide, how that may affect the dynamics within the various franchises that we have?
就口服 semaglutide 而言,這可能如何影響我們擁有的各種特許經營權的動態?
Enrique A. Conterno - SVP, President of Lilly Diabetes and President of Lilly USA
Enrique A. Conterno - SVP, President of Lilly Diabetes and President of Lilly USA
Yes.
是的。
So first, I think it's extremely important, I think you made some reference to this, is that we look at the Phase III trials and whether there's going to be some of these trade-offs between efficacy, the side effect profile, and a view that they also have in real life, is this product going to perform given that it may require some strict adherence when it comes to fasting and water intake and so forth.
所以首先,我認為這非常重要,我認為你提到了這一點,我們看看 III 期試驗,以及是否會在療效、副作用和觀點之間進行一些權衡他們在現實生活中也有,考慮到在禁食和飲水等方面可能需要嚴格遵守,該產品是否會發揮作用。
So, we need to see more data.
所以,我們需要看到更多的數據。
Novo has explicitly expressed this desire to price this product comparable to injectable GLP-1, but it's going to position the products very early in that treatment, continue to compete with some of the other orals.
Novo 已明確表示希望將該產品的價格與可注射的 GLP-1 相媲美,但它將在該治療的早期定位該產品,繼續與其他一些口服藥物競爭。
So we need to see how that is going to work and given that today, SGLT2s -- and we look at the value proposition of Jardiance, for example, which is a bit difficult for that product to match.
所以我們需要看看它是如何運作的,鑑於今天,SGLT2s——我們看看 Jardiance 的價值主張,例如,該產品有點難以匹配。
So, at the end of the day, how will payers view much different price points for an oral GLP-1.
因此,歸根結底,付款人將如何看待口服 GLP-1 的不同價格點。
So, there's a lot of speculation.
所以,有很多猜測。
We need to see more data before we can provide a more educated sense of where -- how successful that product will be and the impact on the rest of the diabetes market.
我們需要看到更多的數據,然後才能對產品的成功程度以及對糖尿病市場其他部分的影響提供更有根據的認識。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Great.
偉大的。
Thanks, Enrique.
謝謝,恩里克。
Operator
Operator
We'll go to the line of Chris Schott with JPMorgan.
我們將與摩根大通一起前往 Chris Schott。
Christopher Thomas Schott - Senior Analyst
Christopher Thomas Schott - Senior Analyst
Great.
偉大的。
Just two questions on Taltz, if I could.
如果可以的話,關於 Taltz 的兩個問題。
One, can you just elaborate a little bit more on the opportunity for Taltz in psoriatic arthritis?
一,您能否詳細說明 Taltz 治療銀屑病關節炎的機會?
I think one of your competitors has highlighted this as maybe equal magnitude of opportunity to the original psoriasis kind of label.
我認為您的一個競爭對手已經強調了這一點,這可能與最初的牛皮癬標籤具有同等的機會。
I'm just interested in how you're thinking about that market as we look at the launch in '18.
我只是對您在我們查看 18 年的發佈時如何看待該市場感興趣。
And the second question on Taltz is about the pricing dynamics in '18.
關於 Taltz 的第二個問題是關於 18 年的定價動態。
We had a couple of data points about this being a more competitive pricing environment than we've seen in the past.
我們有幾個數據點表明這是一個比我們過去看到的更具競爭力的定價環境。
I'm just interested on your thoughts on how pricing is going to shake out for this market as we think about this year and longer-term?
我只是對您對我們考慮今年和更長期的定價將如何影響這個市場的想法感興趣?
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Thank you, Chris.
謝謝你,克里斯。
So Christi, you can talk about the opportunity that we see in psoriatic arthritis and the sort of pricing dynamics as we head into this year?
那麼克里斯蒂,您可以談談我們在銀屑病關節炎中看到的機會以及我們進入今年的定價動態嗎?
Christi Shaw - SVP and President of Lilly Bio-Medicines
Christi Shaw - SVP and President of Lilly Bio-Medicines
Absolutely.
絕對地。
So we're very excited about the launch of Taltz in psoriatic arthritis.
所以我們對 Taltz 在銀屑病關節炎中的推出感到非常興奮。
It's already approved in Japan, approved in the U.S. in December, and January in Europe.
它已經在日本獲得批准,12 月在美國獲得批准,1 月在歐洲獲得批准。
And the -- a marker for the psoriatic arthritis opportunity would be to look at COSENTYX.
並且 - 銀屑病關節炎機會的標誌是看看 COSENTYX。
More than -- only less than 40% of the scripts for COSENTYX are actually in the dermatology office.
超過 - 只有不到 40% 的 COSENTYX 腳本實際上在皮膚科辦公室。
So, we believe this is a really large opportunity in addition to the ankylosing spondylitis.
所以,我們認為這是除了強直性脊柱炎之外的一個非常大的機會。
And we expect that our uptake will be very similar to COSENTYX in PsA as we were in psoriasis.
我們預計我們在 PsA 中的吸收將與我們在銀屑病中的 COSENTYX 非常相似。
So that market, we think, will be very large, and we think we're competitive.
因此,我們認為,這個市場將非常大,而且我們認為我們具有競爭力。
We're the only IL-17 that has in our label structure data as well as patients who have not responded well to TNFs.
我們是唯一在我們的標籤結構數據中具有 IL-17 以及對 TNF 反應不佳的患者。
And so being very competitive, the rheumatologist like the data, and they also like the PASI 100 score.
因此非常有競爭力,風濕病學家喜歡這些數據,他們也喜歡 PASI 100 分數。
So we do think that, that will be a great market for us.
所以我們確實認為,這對我們來說將是一個巨大的市場。
And remember, we're not going to the same customer, we're going to a new -- entirely new office in rheumatology.
請記住,我們不會去同一個客戶,我們要去一個新的——全新的風濕病學辦公室。
And then in terms of pricing, in terms of pricing with Taltz this year versus last year and how that relates to access, our access this year will be very similar to last year from a competitive dynamics.
然後在定價方面,就今年與去年與 Taltz 的定價以及這與訪問的關係而言,我們今年的訪問將與去年非常相似,從競爭動態來看。
This is a marketplace where unlike other areas, we actually have a lot of patients that continually turn over.
這是一個與其他領域不同的市場,實際上我們有很多患者不斷翻身。
And so, as you see with the uptake of Taltz at launch and continuing, we don't believe that, that will be an issue for us to get access to patients.
因此,正如您在 Taltz 在發布和繼續使用時所看到的那樣,我們認為這不會成為我們接觸患者的問題。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Thanks, Christi.
謝謝,克里斯蒂。
Operator
Operator
We'll go to the line of David Risinger with Morgan Stanley.
我們將與摩根士丹利一起前往 David Risinger。
David Reed Risinger - MD in Equity Research and United States Pharmaceuticals Analyst
David Reed Risinger - MD in Equity Research and United States Pharmaceuticals Analyst
So, I have three questions.
所以,我有三個問題。
The first is, I'm hoping that you can frame the Animal Health revenue growth prospects in coming quarters.
首先是,我希望你能在未來幾個季度製定動物保健收入增長前景。
Obviously, the business was down in the fourth quarter.
顯然,該業務在第四季度出現下滑。
You expect it to flatten out and then return to growth.
您期望它會趨於平緩,然後恢復增長。
But if you could help us with our modeling in the next quarter or two, that would be helpful.
但是,如果您能在接下來的一兩個季度幫助我們進行建模,那將會很有幫助。
And also, as part of that commentary, if you could just remind us what the top 2 to 3 new product revenue drivers are in Animal Health.
此外,作為評論的一部分,如果你能提醒我們動物保健領域的前 2 到 3 大新產品收入驅動因素是什麼。
The second question is, could you comment on the timing of Phase II Alzheimer's readouts with cognitive efficacy data?
第二個問題是,您能否用認知功效數據評論 II 期阿爾茨海默氏症讀數的時間?
And then third, do you expect the tax rate to decline beyond 2018 as you optimize your tax structuring?
第三,隨著您優化稅收結構,您是否預計稅率會在 2018 年之後下降?
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Great, Dave, thank you for the question.
太好了,戴夫,謝謝你的問題。
So, Jeff, we'll go to you for Animal Health growth prospects in the coming quarters and some of the key new product drivers.
因此,傑夫,我們將向您介紹未來幾個季度的動物健康增長前景以及一些關鍵的新產品驅動因素。
Josh, I'm actually going to go to you then next to get on line for tax rate beyond 2018.
喬希,我實際上要去找你,然後接下來上網查詢 2018 年以後的稅率。
And then Jan, if you'd like to comment on timing for some of the Phase II read-outs in the Alzheimer's space.
然後是 Jan,如果您想評論阿爾茨海默氏症領域中一些 II 期讀數的時間安排。
Jeff?
傑夫?
Jeffrey N. Simmons - SVP and President of Elanco Animal Health
Jeffrey N. Simmons - SVP and President of Elanco Animal Health
Yes, we think, David, at kind of at a higher level on Animal Health, I would say that our Q4 results were consistent with our expectations we set in guidance in December.
是的,我們認為,大衛,在動物健康方面處於更高水平,我想說我們的第四季度結果與我們在 12 月指導中設定的預期一致。
We specifically said then that we expect 2018 revenues to be flat to slightly increasing versus 2017.
我們當時特別表示,我們預計 2018 年的收入將與 2017 年持平或略有增長。
Another note I would make is, fourth quarter revenue decreased 7% excluding FX, but -- and this was driven by volume.
我要說明的另一個問題是,第四季度的收入在不包括外彙的情況下下降了 7%,但是——這是由數量驅動的。
But importantly, we're starting to see a return to price growth in the market, and we increased at 1% in the fourth quarter.
但重要的是,我們開始看到市場價格恢復增長,第四季度增長了 1%。
So when you look to growth and look to modeling, I would say this, again, 2017, clean food in competition.
因此,當您關注增長並關注建模時,我會再次說,2017 年,競爭中的清潔食品。
We underestimated the impact of that, that's what's impacted and driven our results, and some competitive pressures in the companion animal market.
我們低估了它的影響,這就是影響和推動我們業績的因素,以及伴侶動物市場的一些競爭壓力。
So, for 2018 specifically, we forecast revenue growth to be flat to slightly up.
因此,特別是對於 2018 年,我們預測收入增長將持平至小幅增長。
We expect 2018 to be the year of kind of a transition as we continue to evolve our product mix against headwinds.
我們預計 2018 年將是轉型之年,因為我們將繼續發展我們的產品組合以應對逆風。
We see slightly negative growth in the first half of 2018, primarily from the continuing impact of clean food.
我們看到 2018 年上半年略有負增長,主要是由於清潔食品的持續影響。
However, the second half of the year, we expect our 8 launches, and I'll touch on those here, will drive top line growth.
然而,今年下半年,我們預計我們的 8 次發布(我將在此談及)將推動收入增長。
So, within the portfolio, we expect low to mid-single-digit growth in companion animals, offset by a low- to single-digit decline in food animals.
因此,在投資組合中,我們預計伴侶動物的低至中個位數增長被食用動物的低至個位數下降所抵消。
As Dave noted, I think we will see Galliprant continue to grow.
正如 Dave 所說,我認為我們將看到 Galliprant 繼續增長。
We're seeing close to 30% quarter-on-quarter growth in the canine pain market.
我們看到犬類疼痛市場的季度環比增長接近 30%。
We're up to 12% market share, we see that being a key growth driver.
我們的市場份額高達 12%,我們認為這是一個關鍵的增長動力。
I would combine that with last year's launch of INTERCEPTOR PLUS and the share that we've taken from our heart guard would be another big driver from our business.
我會將其與去年推出的 INTERCEPTOR PLUS 結合起來,我們從心臟保護者那裡獲得的份額將成為我們業務的另一個重要推動力。
And then we continue to see our companion animal pair set aside broader portfolio.
然後我們繼續看到我們的伴侶動物對留出更廣泛的投資組合。
Credelio, our first tick, flea launch, that is going on this quarter in all 3 major markets, Japan, Europe and the U.S. So, Credelio would be the third.
Credelio,我們的第一個跳蚤發布,本季度將在日本、歐洲和美國這三個主要市場進行。因此,Credelio 將是第三個。
And then on the food animal side, we continue to see our vaccine portfolio that we acquired from Lumen and Salmonella, with vaccines being a key growth driver as well.
然後在食用動物方面,我們繼續看到我們從 Lumen 和沙門氏菌獲得的疫苗組合,疫苗也是關鍵的增長動力。
So, hopefully that gives you a little guidance on our food and companion animal business, first half, second half of the year.
所以,希望這能給你一些關於我們上半年和下半年的食品和伴侶動物業務的指導。
And again, I would emphasize flat to slightly growing in '18.
再一次,我會強調在 18 年持平到略微增長。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Great.
偉大的。
Thanks, Jeff.
謝謝,傑夫。
Josh?
喬什?
Joshua L. Smiley - Senior VP & CFO
Joshua L. Smiley - Senior VP & CFO
Okay.
好的。
On tax rate, first, for 2018, as we mentioned, we are estimating about 18%, which is about a 350 point -- basis point improvement from the prior outlook.
在稅率方面,首先,正如我們所提到的,我們估計 2018 年的稅率約為 18%,這大約是 350 個基點——比之前的展望提高了 350 個基點。
Like every other company that's reported or will, I think we -- first we have to caveat that by saying that's based on our interpretation and read today of the law.
就像所有其他已報告或將要報告的公司一樣,我認為我們 - 首先我們必須通過說這是基於我們對法律的解釋和閱讀來警告這一點。
It's very complex.
這很複雜。
We are still waiting for future guidance and regulations from the IRS.
我們仍在等待 IRS 的未來指導和法規。
But, based on that assessment, 18 -- we think 18% is sustainable.
但是,根據該評估,18 - 我們認為 18% 是可持續的。
And we will certainly look through planning to take advantage of the incentives that are built into the law to bring that down over time.
我們當然會通過計劃來利用法律中內置的激勵措施,隨著時間的推移將其降低。
So, we'll look to -- a lot of work still to go there, but certainly assume a sustainable 18% and then opportunities to bring it down over time.
所以,我們會期待——還有很多工作要做,但肯定會假設可持續的 18%,然後有機會隨著時間的推移將其降低。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Thank you, Josh.
謝謝你,喬希。
Jan?
簡?
Jan M. Lundberg - Executive VP of Science & Technology and President of Lilly Research Laboratories
Jan M. Lundberg - Executive VP of Science & Technology and President of Lilly Research Laboratories
Yes.
是的。
In relation to dementia studies then, the symptomatic one is in Parkinson's, dementia, and that has a read-out mid-2019.
關於癡呆症研究,有症狀的是帕金森氏症,癡呆症,並且在 2019 年年中公佈。
The N3pG program will take somewhat longer since there is 18 months' treatments there.
N3pG 計劃需要更長的時間,因為那裡有 18 個月的治療時間。
So, in about 2 years.
所以,在大約 2 年內。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Okay, great.
好,太棒了。
Thank you, Jan.
謝謝你,簡。
Operator
Operator
We'll go to the line of Greg Gilbert with Deutsche Bank.
我們將與德意志銀行聯繫 Greg Gilbert。
Gregory B. Gilbert - MD and Senior Analyst
Gregory B. Gilbert - MD and Senior Analyst
First, in diabetes, lots of focus on GLP-1, obviously.
首先,在糖尿病中,很明顯,很多人都關注 GLP-1。
But Enrique, I was curious what you thought the impact might be, if any, when Merck enters with some combo products, or at least a combo of DPP-4 SGLT2?
但是恩里克,我很好奇你認為當默克公司帶著一些組合產品進入市場時,或者至少是 DPP-4 SGLT2 的組合時,影響可能是什麼?
And kind of what have you learned in the marketplace about the market's willingness to use that kind of combo?
您從市場上了解到市場願意使用這種組合的哪些方面?
And what are you expecting from Merck, given that they haven't launched something into the space in a while and how that might affect you?
鑑於默克公司已經有一段時間沒有向該領域推出任何產品,您對默克公司有什麼期望,這可能會對您產生什麼影響?
And secondly, Dave, lots of guesswork around what you would buy?
其次,戴夫,你會買什麼?
What you will buy if you could buy?
如果可以買,你會買什麼?
When it would happen?
什麼時候會發生?
But -- hard for you to answer that, but what could you say about how the pace and focus of BD?
但是 - 你很難回答這個問題,但你對 BD 的速度和重點有什麼看法?
How that has changed since you took over?
自從你接手以來,情況發生了怎樣的變化?
There's specific things you can point to like changes in the team, changes in priority, changes in team focus, et cetera, short of predicting what you're going to do next.
你可以指出一些具體的事情,比如團隊的變化、優先級的變化、團隊焦點的變化等等,而不是預測你接下來要做什麼。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Thank you, Greg.
謝謝你,格雷格。
So Enrique, if you can comment on the potential impact of another DPP-4 SGLT2 combo coming in.
所以恩里克,如果你能評論另一個 DPP-4 SGLT2 組合的潛在影響。
And then Dave, any changes in our approach to BD since you have taken over as CEO.
然後是戴夫,自從您接任首席執行官以來,我們對 BD 的處理方式的任何變化。
Enrique?
恩里克?
Enrique A. Conterno - SVP, President of Lilly Diabetes and President of Lilly USA
Enrique A. Conterno - SVP, President of Lilly Diabetes and President of Lilly USA
Very good.
很好。
So, as I mentioned, we view additional competitors coming into the SGLT2 class, paradoxically, as a positive because we believe it's going to be an important catalyst for growth, and it's going to help and -- the class, but also, given Jardiance's strong position, we will likely be the main beneficiary.
因此,正如我所提到的,我們認為進入 SGLT2 級別的其他競爭對手是積極的,因為我們相信這將成為增長的重要催化劑,並且會有所幫助,而且 - 級別,而且,鑑於 Jardiance 的強勢地位,我們很可能是主要受益者。
So, your question was specific to the combo, and the combo of ertugliflozin with DPP-4.
所以,你的問題是針對組合的,以及 ertugliflozin 與 DPP-4 的組合。
We -- I can't comment on Merck's strategy, but the -- when we look at current practices from physicians prescribing diabetes products, they prefer not to prescribe those combinations.
我們 - 我無法評論默克的策略,但是 - 當我們查看醫生開具糖尿病產品的當前做法時,他們寧願不開這些組合。
We do have that experience with Glyxambi, so we view that as a long-term proposition for Merck.
我們確實有使用 Glyxambi 的經驗,因此我們認為這是默克的長期建議。
Now we don't know exactly what their strategy is but clearly, for that product, first of all, to be successful, they're going to have to establish the benefit of ertugliflozin.
現在我們並不確切地知道他們的戰略是什麼,但很明顯,對於該產品,首先,要獲得成功,他們將不得不確定 ertugliflozin 的好處。
So, we are, of course, prepared.
所以,我們當然做好了準備。
We have a number of competitors entering the diabetes space, but I feel very good in terms of where each one of our brands stands today in terms of the benefits that it provides.
我們有許多競爭對手進入糖尿病領域,但就我們每個品牌今天所提供的好處而言,我感覺非常好。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Thank you, Enrique.
謝謝你,恩里克。
Dave?
戴夫?
David A. Ricks - Chairman, CEO & President
David A. Ricks - Chairman, CEO & President
Yes, thanks, Gregg, on the question.
是的,謝謝,格雷格,關於這個問題。
Of course, we can't comment on things that haven't happened yet.
當然,我們不能對尚未發生的事情發表評論。
We do have ambition to step up our game in BD.
我們確實有雄心壯志在 BD 中加強我們的遊戲。
And as such, we've undertaken a series of things to investigate why have we done a bit less through time, where has that occurred in the pipeline space.
因此,我們已經採取了一系列措施來調查為什麼我們隨著時間的推移做得更少,這在管道空間中發生了什麼。
I think we've been pretty clear through the last year about our ambition in the Phase I, Phase II.
我認為去年我們已經非常清楚我們在第一階段和第二階段的雄心壯志。
So preproof-of-concept, earlier clinical assets is the main target.
因此,概念驗證、早期臨床資產是主要目標。
And that's not just because we decided that, it's because that's where Lilly is relatively underrepresented and there's a lot more to go after at price points which we think are attractive.
這不僅僅是因為我們決定這樣做,而是因為禮來公司在這方面的代表性相對不足,而且在我們認為具有吸引力的價格點上還有很多事情要做。
We have done some specific things in the company.
我們在公司做了一些具體的事情。
One public thing which people know about is the realignment of the business development function nested within our Lilly Research Labs, our R&D organization.
人們知道的一件公開的事情是重新調整嵌套在我們的研發組織 Lilly 研究實驗室內的業務開發功能。
I think that's an important change, if not psychologically, as we shift our attitude towards this becoming a core part of innovation in our company along with strengthening our own labs.
我認為這是一個重要的變化,即使不是心理上的,因為我們轉變態度,將其轉變為我們公司創新的核心部分,同時加強我們自己的實驗室。
We have also increased resources, both human and allocating balance sheet and income statement capacity or yet to be done deals, so that's not a friction as we look at bringing things in.
我們還增加了資源,包括人力和分配資產負債表和損益表的能力或尚未完成的交易,因此在我們考慮引入事物時這不是摩擦。
And, the final thing I'll say is we have core metrics now we're looking at in terms of number of prospects we're evaluating so that we have enough substrate to then execute the right deals across.
而且,我要說的最後一件事是,我們現在有核心指標,我們正在評估我們正在評估的潛在客戶數量,以便我們有足夠的基礎來執行正確的交易。
What hasn't changed is the discipline we're going to undertake to make sure these are not just "strategic" without the financial support, but they check all the boxes.
沒有改變的是我們將採取的紀律,以確保這些不僅僅是沒有財政支持的“戰略性”,而是他們檢查所有方框。
They enhance our therapeutic strategies, they can produce -- have a good shot of producing strong value for shareholders through time, and they fit what we know how to do, so we can execute once we do bring them in.
它們增強了我們的治療策略,它們可以產生——隨著時間的推移,它們很有可能為股東創造強大的價值,它們符合我們知道如何做的事情,所以一旦我們引入它們,我們就可以執行。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Great.
偉大的。
Thank you, Dave.
謝謝你,戴夫。
Operator
Operator
We'll go to the line of Umer Raffat with Evercore.
我們將與 Evercore 一起前往 Umer Raffat 的路線。
Umer Raffat - Senior MD & Fundamental Research Analyst
Umer Raffat - Senior MD & Fundamental Research Analyst
First, if I may, can you please give us some color into any DVT death seen with baricitinib?
首先,如果可以的話,您能給我們一些關於使用巴瑞替尼導致的 DVT 死亡的顏色嗎?
Perhaps some visibility to how many and the consequence -- and what happened.
也許對數量和後果以及發生的事情有所了解。
Secondly, I know you mentioned in passing, but would love to get your thoughts on real-world usage of the carefully calibrated pre and post-dose staffing period seen with oral sema and the specific water volumes, like how does that play out in real-world setting based on all the diabetes experience you guys have?
其次,我知道您順便提到了,但很想了解您對口服 sema 和特定水量所見的仔細校準的給藥前後人員配備期的實際使用情況,例如實際情況如何-基於你們所有糖尿病經驗的世界設置?
And then can you comment on meds?
然後你能評論一下藥物嗎?
And then finally, on NGF, my question is from a commercial setting, how do you seek to manage concomitant NSAID usage to mitigate the type 2 RPO risk when concomitant NSAIDs are taken.
最後,關於 NGF,我的問題來自商業環境,當同時服用 NSAID 時,您如何尋求管理伴隨的 NSAID 使用以減輕 2 型 RPO 風險。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
All right.
好的。
Great.
偉大的。
Thank you very much for the questions.
非常感謝您的提問。
Let me summarize.
讓我總結一下。
So I'm going to start with Enrique actually with that second question on how we see some of the oral sema dosing potential issues playing out in the real world.
因此,我將從 Enrique 開始,實際上是第二個問題,即我們如何看待現實世界中出現的一些口服 sema 給藥潛在問題。
And then, Christi, the other 2 would be for you.
然後,克里斯蒂,另外兩個是給你的。
Any information we can share on things we've seen related to DVT depth with baricitinib in our clinical trial program.
在我們的臨床試驗計劃中,我們可以分享與使用巴瑞替尼的 DVT 深度相關的任何信息。
And then how we intend to manage concomitant NSAID use as we would go to market in the future with tanezumab.
然後我們打算如何管理伴隨的 NSAID 使用,因為我們將在未來使用 tanezumab 進入市場。
Enrique?
恩里克?
Enrique A. Conterno - SVP, President of Lilly Diabetes and President of Lilly USA
Enrique A. Conterno - SVP, President of Lilly Diabetes and President of Lilly USA
Yes, I -- that is a question probably better for Novo than for us.
是的,我——這個問題對 Novo 來說可能比對我們更好。
But as a frame, anything that introduces complexity in the lives of people with diabetes has a number of headwinds, so we look to basically develop products so that can be appeared simply that offer a number of benefits.
但作為一個框架,任何給糖尿病患者的生活帶來複雜性的東西都會遇到許多不利因素,因此我們希望從根本上開發能夠提供許多好處的產品。
And that is the mantra about how we think about development of products.
這就是我們如何看待產品開發的口頭禪。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Great.
偉大的。
Thank you, Enrique.
謝謝你,恩里克。
Christi?
克里斯蒂?
Christi Shaw - SVP and President of Lilly Bio-Medicines
Christi Shaw - SVP and President of Lilly Bio-Medicines
Sure.
當然。
So, I would note there were 2 reported deaths for patients with events of pulmonary embolism in the clinical trial program.
因此,我注意到在臨床試驗計劃中有 2 例發生肺栓塞事件的患者死亡的報告。
One death occurred in the baricitinib group after 523 days after the first dose.
在第一次給藥後 523 天后,巴瑞替尼組發生了 1 例死亡。
And one death occurred in the methotrexate group after 234 days methotrexate treatment.
甲氨蝶呤治療234天后甲氨蝶呤組發生1例死亡。
Of note, as we have resubmitted and disclosed more data on our resubmission to the FDA, one of the things that we looked at is the largest pool that we have of patients exposed to baricitinib.
值得注意的是,由於我們已經重新提交並披露了更多關於我們重新提交給 FDA 的數據,我們關注的一件事是我們擁有的最大的暴露於巴瑞替尼的患者池。
So all of our clinical trials and also the extension study, we found that in the 2 milligram, the incidents of DVT and PE were 0.5, and in the 4 milligrams, it was 0.5 as well.
所以我們所有的臨床試驗和擴展研究,我們發現在 2 毫克中,DVT 和 PE 的發生率為 0.5,在 4 毫克中,也是 0.5。
And remember, that's a background rate in RA of 0.3 and 0.8, so well within the background rate of RA.
請記住,這是 RA 的背景率為 0.3 和 0.8,完全在 RA 的背景率之內。
So that's part of our resubmission package as well as the Phase II clinical trials, and atopic derm we didn't see any as well.
所以這是我們重新提交包以及 II 期臨床試驗的一部分,我們也沒有看到任何特應性皮膚。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
And then in terms of utilization of concomitant NSAIDs with tanezumab and how that's being managed in the clinical trials and how we might envision that playing out upon commercialization.
然後是使用伴隨的非甾體抗炎藥與 tanezumab 以及如何在臨床試驗中進行管理,以及我們如何設想在商業化中發揮作用。
Christi Shaw - SVP and President of Lilly Bio-Medicines
Christi Shaw - SVP and President of Lilly Bio-Medicines
So, we did exclude concomitant use of NSAIDs in our trials of chronic use.
因此,在我們的長期使用試驗中,我們確實排除了同時使用非甾體抗炎藥。
And we'll see what the label looks like once the data comes out and once the FDA approves it and then what the label looks like.
一旦數據出來,一旦 FDA 批准,我們就會看到標籤是什麼樣子,然後標籤是什麼樣子。
And then we'll be able to -- in the future, be able to tell you how we'll commercialize it.
然後我們將能夠 - 在未來,能夠告訴你我們將如何將它商業化。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Great.
偉大的。
Thank you, Christi.
謝謝你,克里斯蒂。
Operator
Operator
We'll go to the line of Marc Goodman with UBS.
我們將與瑞銀一起前往馬克古德曼的路線。
Marc Harold Goodman - MD and United States Healthcare Analyst
Marc Harold Goodman - MD and United States Healthcare Analyst
Just a couple of product questions.
只是幾個產品問題。
Trajenta looked very strange in the fourth quarter here in the U.S. I was wondering if you could just give us a flavor for what happened there.
Trajenta 在美國第四季度看起來很奇怪。我想知道你是否可以讓我們了解那裡發生的事情。
And then second on Trulicity, obviously, ramping up nicely in the U.S. I'm just curious if there was anything strange with respect to pricing or inventory in the quarter?
然後是 Trulicity 的第二名,顯然,它在美國的發展勢頭不錯。我只是好奇本季度的定價或庫存是否有什麼奇怪的地方?
Was that just a completely clean quarter relative to the previous 4 quarters, just so we can understand the ramp?
相對於前四個季度,那隻是一個完全乾淨的季度,只是為了讓我們能夠理解坡道嗎?
And then you mentioned a little bit on Basaglar before, but maybe you could also just talk to the past couple of quarters so we can really get a better understanding what the underlying pricing is of this product, including all the rebates.
然後你之前提到了一些關於 Basaglar 的內容,但也許你也可以談談過去幾個季度,這樣我們才能真正更好地了解這個產品的基本定價是什麼,包括所有的回扣。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Great.
偉大的。
Mark, thank you for the questions.
馬克,謝謝你的提問。
Enrique, all for you.
恩里克,一切為了你。
If you'd like to comment on some of the U.S. dynamics we're seeing for Trajenta, Trulicity and Basaglar.
如果您想評論我們在 Trajenta、Trulicity 和 Basaglar 看到的一些美國動態。
Enrique A. Conterno - SVP, President of Lilly Diabetes and President of Lilly USA
Enrique A. Conterno - SVP, President of Lilly Diabetes and President of Lilly USA
Very good.
很好。
So, let me start with Trajenta.
所以,讓我從 Trajenta 開始。
We did have an unfavorable impact due to our changes in estimates for rebates and discounts for the quarter in the case of Tradjenta, roughly $10 million as it relates to Lilly revenue.
由於我們對 Tradjenta 的季度回扣和折扣的估計發生了變化,我們確實產生了不利影響,因為它與禮來公司的收入有關,大約為 1000 萬美元。
You may recall that in Q3 of 2017, so last quarter, we actually had a favorable adjustment.
您可能還記得在 2017 年第三季度,所以上個季度,我們實際上進行了有利的調整。
So sequentially, it does look like an anomaly.
因此,按順序,它確實看起來像一個異常。
You asked about Basaglar.
你問過巴薩格勒。
We do see very strong sequential growth for Basaglar, 24% TRx quarter-on-quarter.
我們確實看到 Basaglar 的環比增長非常強勁,TRx 環比增長 24%。
We do have high rebates.
我們確實有很高的回扣。
Part of this is basically a channel accrual when it comes to -- given the expected increased utilization in part D, starting January 1. And by the way, we've seen excellent uptake.
考慮到從 1 月 1 日開始 D 部分的預期利用率提高,其中一部分基本上是渠道應計。順便說一句,我們已經看到了很好的吸收。
When we look at Basaglar today, at the first few weeks, we're now basically capturing about 25% of the new patients in the basal insulin class, so excited about the growth prospects.
當我們今天看 Basaglar 時,在最初的幾週內,我們現在基本上捕獲了基礎胰島素類別中約 25% 的新患者,對增長前景感到非常興奮。
And then when we look at Trulicity, there was some buy-in, roughly about $25 million when it comes to inventories.
然後當我們查看 Trulicity 時,有一些買入,大約 2500 萬美元的庫存。
I -- outside of that, I -- we do see a lot of movement when it comes to gross to net and so forth.
我——除此之外,我——我們確實看到了很多關於淨淨值等方面的變化。
But what I will say when we look at our diabetes products is to look at them really more over time and trying to get a complete picture by looking at rolling quarters.
但是,當我們查看我們的糖尿病產品時,我要說的是隨著時間的推移更多地查看它們,並試圖通過查看滾動季度來獲得完整的畫面。
But we are, once again, excited about the sequential growth that Trulicity is having.
但我們再次對 Trulicity 的連續增長感到興奮。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Great.
偉大的。
Thank you, Enrique.
謝謝你,恩里克。
Operator
Operator
We'll go to the line of Geoff Meacham with Barclays.
我們將與巴克萊一起前往 Geoff Meacham。
Geoffrey Christopher Meacham - MD & Senior Research Analyst
Geoffrey Christopher Meacham - MD & Senior Research Analyst
Dave, I know you're still on the Elanco strategic review, but how does the tax policy or the new product launches change your view of its internal value?
戴夫,我知道您仍在進行 Elanco 戰略審查,但稅收政策或新產品的推出如何改變您對其內部價值的看法?
Or is it still about its margin contribution?
或者它仍然是關於它的保證金貢獻?
And then a couple of product questions.
然後是幾個產品問題。
One for Forteo, good forward trends for a late-cycle product.
Forteo 的一個,後期產品的良好前瞻趨勢。
Just help us with some insight for 4Q and then going forward.
只需幫助我們了解 4Q 的一些見解,然後繼續前進。
And then on abemaciclib, how does a recent pricing action we saw with IBRANCE in Europe impact either your opportunity or your investment there?
然後在 abemaciclib 上,我們最近在歐洲看到的 IBRANCE 定價行為如何影響您的機會或您在那裡的投資?
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Great.
偉大的。
Jeff, thank you for the question.
傑夫,謝謝你的問題。
So Dave, we'll start with you on the question on some of the impact of tax policy and some other factors on our Elanco decision-making process.
所以戴夫,我們將從稅收政策的一些影響和其他一些因素對我們 Elanco 決策過程的影響開始。
Sue, if I can then go to you to talk about some of the recent announcements that were made on pricing for a competitor product in the CDK4/6 space in Europe.
蘇,如果我能再去找你談談最近在歐洲 CDK4/6 領域的競爭對手產品定價的一些公告。
And then Christi on the Forteo question here in the U.S. Dave?
然後克里斯蒂在美國的 Forteo 問題上發言,戴夫?
David A. Ricks - Chairman, CEO & President
David A. Ricks - Chairman, CEO & President
Yes, thanks for your question.
是的,謝謝你的提問。
Elanco, more or less, since we announced the strategic review in October, the basic assumptions and the way we're conducting it haven't really changed.
Elanco,或多或少,自從我們在 10 月份宣布戰略審查以來,基本假設和我們進行審查的方式並沒有真正改變。
Of course, tax makes everything a little bit more valuable and that's contemporized in our thinking.
當然,稅收使一切都變得更有價值,這在我們的思想中是同時代的。
Elanco, I think, it's -- there's a 2-part story.
Elanco,我想,它是——有一個兩部分的故事。
One is innovation on the top line, and I think we've commented on that this quarter.
一個是頂線的創新,我認為我們已經在本季度對此發表了評論。
I think there's been great progress.
我認為已經有了很大的進步。
And both the introduction of new products as well as approvals recently, that's a piece of this that we're factoring going forward as a growing company in Animal Health.
無論是新產品的推出還是最近的批准,這都是我們作為動物保健領域成長型公司向前發展的一部分。
And then the margin expansion is a significant opportunity for Animal Health and one the team is very focused on.
然後利潤率的擴大對 Animal Health 來說是一個重要的機會,也是團隊非常關注的一個機會。
So all those things are true.
所以所有這些都是真的。
I think the -- and now, of course, then must ask, what's the most valuable path forward for Lilly shareholders, to hold, to spend, to partner in some other way and that's still ongoing.
我認為——當然,現在必須問,對於禮來公司的股東來說,持有、花費、以其他方式合作的最有價值的道路是什麼,而且這仍在進行中。
But the -- more or less, the direction of those assumptions is the same when we started this, and that's good news as we continue to work through that project.
但是,當我們開始這個項目時,這些假設的方向或多或少是相同的,這是一個好消息,因為我們將繼續完成該項目。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Great.
偉大的。
Thanks, Dave.
謝謝,戴夫。
Sue?
起訴?
Susan Mahony - Senior VP & President of Lilly Oncology
Susan Mahony - Senior VP & President of Lilly Oncology
Yes.
是的。
I can't comment on Pfizer's announcement.
我無法對輝瑞的公告發表評論。
What I can say is, we are ready for our launch in Europe.
我能說的是,我們已經準備好在歐洲推出。
We submitted last year in Europe and in Japan.
我們去年在歐洲和日本提交了申請。
We are hopefully expecting approval in both those geographies later this year.
我們希望在今年晚些時候在這兩個地區獲得批准。
We are prepared for launch and we're prepared for appropriate access and reimbursement for patients where there is a considerable unmet need in Europe.
我們已準備好推出,我們已準備好為歐洲存在大量未滿足需求的患者提供適當的訪問和報銷。
Just an update on the U.S., the uptake so far has been very promising.
只是美國的最新情況,到目前為止,吸收情況非常有希望。
We feel really good about the performance to date.
我們對迄今為止的表現感覺非常好。
And that is based on the MONARCH 1 and MONARCH 2 population.
這是基於 MONARCH 1 和 MONARCH 2 的人口。
That's about 30% of the patients available.
這大約是可用患者的 30%。
And we are anticipating approval in the first half of this year based on the MONARCH 3. That's the first-line indication.
我們預計今年上半年會根據 MONARCH 3 獲得批准。這是一線跡象。
Again, the performance looks good so far.
同樣,到目前為止,性能看起來不錯。
And we feel very confident in the U.S. performance as well as the opportunity in Europe and Japan.
我們對美國的表現以及歐洲和日本的機會充滿信心。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Great.
偉大的。
Thank you, Sue.
謝謝你,蘇。
Christi?
克里斯蒂?
Christi Shaw - SVP and President of Lilly Bio-Medicines
Christi Shaw - SVP and President of Lilly Bio-Medicines
Yes.
是的。
So, our U.S. sales of Forteo in Q4 grew 32% versus the Q3 of 30%.
因此,我們第四季度在美國的 Forteo 銷售額增長了 32%,而第三季度增長了 30%。
So thank you for the question because there was some unique dynamics in Q4.
所以謝謝你的問題,因為第四季度有一些獨特的動態。
One was, we benefited from the net price adjustment to rebates and discounts related to Medicaid, whereas in most quarters the rebates and discounts lower the realized benefit from list price increases.
一是,我們受益於與 Medicaid 相關的回扣和折扣的淨價格調整,而在大多數季度,回扣和折扣降低了標價上漲的已實現收益。
And the second thing was that in terms of the volume acceleration, we had wholesaler buy-ins that led to an increase in the volume for Q4.
第二件事是,在銷量加速方面,我們有批發商的買入,導致第四季度的銷量增加。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Thank you, Christi.
謝謝你,克里斯蒂。
Operator
Operator
The next question comes from the line of Jason Gerberry with Bank of America.
下一個問題來自美國銀行的 Jason Gerberry。
Jason Matthew Gerberry - MD in US Equity Research
Jason Matthew Gerberry - MD in US Equity Research
Just 2 for me.
對我來說只有2個。
Firstly, on Alimta, your thoughts or expectations if you were to lose the patent suit with the alternative salt form, the 505(b)(2) generic.
首先,在 Alimta 上,如果您以替代鹽形式(505(b)(2) 仿製藥)輸掉專利訴訟,您的想法或期望。
Just curious your thoughts on sort of what type of market share you think a low cost alternative salt form could capture in the oncology setting?
只是好奇您對您認為低成本替代鹽形式可以在腫瘤學環境中獲得何種類型的市場份額的想法?
I don't know if you have any analogs, but with the trial starting tomorrow I'm just curious your thoughts there.
我不知道你有沒有類似的東西,但是從明天開始的審判,我只是好奇你的想法。
And then my second question on the diabetes front.
然後是關於糖尿病方面的第二個問題。
Obviously, conversion of sulfonylurea to higher-cost brands have been kind of a value driver in the space more broadly.
顯然,磺脲類藥物向更高成本品牌的轉變在更廣泛的領域是一種價值驅動因素。
And just trying to get a little bit of sense for the CAROLINA study.
只是想對 CAROLINA 的研究有所了解。
If that study were positive, do you mainly see that as something that drives more conversion to DPP-4?
如果該研究是積極的,您是否主要將其視為推動更多轉換為 DPP-4 的因素?
Or do you see that as a broader catalyst depending upon the cardiovascular profile for SUs to other proprietary classes like SGLT2 or GLP-1?
或者您是否將其視為更廣泛的催化劑,取決於 SU 對其他專有類別(如 SGLT2 或 GLP-1)的心血管特徵?
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Great.
偉大的。
Thank you for the questions.
謝謝你的提問。
So Sue, if you can provide some thoughts on the potential impact if we were to lose the alternate salt form case that's starting soon.
所以蘇,如果我們失去即將開始的替代鹽形式案例,如果你能提供一些潛在影響的想法。
And then Enrique, your thoughts on, if CAROLINA is positive, how that might affect the DPP-4 potentially, SGLT utilization.
然後是 Enrique,你的想法是,如果 CAROLINA 是積極的,這可能如何影響 DPP-4,SGLT 的使用。
Sue?
起訴?
Susan Mahony - Senior VP & President of Lilly Oncology
Susan Mahony - Senior VP & President of Lilly Oncology
Yes.
是的。
With regards to the Alimta patent, as you said, we've got the alternate salt form hearing yet this week in the District Court of Indiana.
關於 Alimta 專利,正如你所說,我們本週還在印第安納州地方法院舉行了替代鹽形式聽證會。
And we feel really confident with regards to our case here.
我們對這裡的案例非常有信心。
And we believe that we can continue to defend this patent and feel very confident in our opportunities to do that.
我們相信我們可以繼續捍衛這項專利,並對我們這樣做的機會充滿信心。
Clearly, in case that didn't happen, we would look at revised guidance.
顯然,如果沒有發生這種情況,我們將查看修訂後的指南。
But at this point in time, we are continuing to drive Alimta performance.
但在這個時間點,我們將繼續推動 Alimta 的表現。
With the KEYNOTE-189 data being presented later this year, we think we have a great opportunity to really continue to consolidate Alimta as a standard of care in first-line setting and to be the preferred chemo in combination with IO.
隨著今年晚些時候公佈的 KEYNOTE-189 數據,我們認為我們有一個很好的機會來真正繼續鞏固 Alimta 作為一線治療的標準,並成為與 IO 結合的首選化療。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Great.
偉大的。
Thank you, Sue.
謝謝你,蘇。
Enrique?
恩里克?
Enrique A. Conterno - SVP, President of Lilly Diabetes and President of Lilly USA
Enrique A. Conterno - SVP, President of Lilly Diabetes and President of Lilly USA
So SUs still represent about 20% of the overall oral diabetes market.
因此,SU 仍佔整個口腔糖尿病市場的 20% 左右。
As a class, as a share of the market, that is declining and has been declining over time.
作為一個類別,作為市場份額,它正在下降,並且隨著時間的推移一直在下降。
Clearly, a positive CAROLINA trial will significantly accelerate that.
顯然,積極的 CAROLINA 試驗將顯著加快這一進程。
My view is that most classes will basically benefit.
我的觀點是,大多數課程基本上都會受益。
It will not be limited to DPP-4s and Trajenta in particular, but we will also see acceleration of both the SGLT2s, in particular Jardiance and the GLP-1 class.
它不僅限於 DPP-4 和 Trajenta,但我們還將看到 SGLT2 的加速,特別是 Jardiance 和 GLP-1 類。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Great.
偉大的。
Thank you, Enrique.
謝謝你,恩里克。
Operator
Operator
We'll go to the line of Vamil Divan with Crédit Suisse.
我們將與瑞士信貸一起前往 Vamil Divan 的行列。
Vamil Kishore Divan - Senior Analyst
Vamil Kishore Divan - Senior Analyst
I had a question about these new co-pay accumulator programs that we're hearing more about.
我有一個關於我們聽到更多關於這些新的共同支付累加器計劃的問題。
So, plans where the co-pay support manufacturers provide does not count towards an individual's deductible.
因此,共同支付支持製造商提供的計劃不計入個人的免賠額。
Just wondering if you could comment on what you're seeing around this issue.
只是想知道您是否可以評論您在此問題上看到的內容。
And is there anything you think Lilly or other pharma companies can do to offset the pressure, specifically wondering about specialty drugs like Taltz with that question.
您認為禮來或其他製藥公司可以做些什麼來抵消壓力,特別是想知道像 Taltz 這樣的特殊藥物有這個問題。
And second one on your CGRP.
第二個關於你的 CGRP。
I'm just curious if you can share a little more in terms of the commercial presentation of that product, in terms of the needle gauge, the device, some of the ways you try and differentiate that product from some of your competitors in terms of how it's delivered.
我只是想知道您是否可以在該產品的商業展示方面分享更多信息,包括針規、設備、您嘗試將該產品與您的一些競爭對手區分開來的一些方法它是如何交付的。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Great, Vamil.
太好了,瓦米爾。
Thank you very much for the questions.
非常感謝您的提問。
So Dave, if you can comment on the question on the co-pay accumulator.
所以戴夫,如果你能就共同支付累加器的問題發表評論。
And then Christi, whatever you can share, you might not be able to fully respond, whatever you can share on some of the commercial presentation for CGRP, galcanezumab.
然後克里斯蒂,無論你能分享什麼,你可能無法完全回應,無論你可以在 CGRP 的一些商業演示中分享什麼,galcanezumab。
Dave?
戴夫?
David A. Ricks - Chairman, CEO & President
David A. Ricks - Chairman, CEO & President
Yes.
是的。
Well, co-pay accumulators, the idea that co-pay employers get credited differently than in the past is actually not really a new idea.
好吧,共同支付累加器,共同支付雇主獲得與過去不同的信用的想法實際上並不是一個新想法。
A lot of people are talking about it this year.
今年很多人都在談論它。
There are, in the back-and-forth between manufacturers and insurers, ways to rebalance that.
在製造商和保險公司之間的反复討論中,有一些方法可以重新平衡這一點。
I think the overall concerning thing is the continuing shift of costs toward consumers.
我認為總體上令人擔憂的事情是成本持續向消費者轉移。
By implementing this program without rebate pass-through, which I think would be an important compensating measure, it just increases the exposure that patients have to their high-deductible plans, and that's a bad idea in our mind.
通過在沒有回扣傳遞的情況下實施該計劃(我認為這將是一項重要的補償措施),它只會增加患者對其高免賠額計劃的風險,這在我們看來是個壞主意。
So -- and policy-wise, we're not for it.
所以——在政策方面,我們不贊成。
There are tactical ways through it.
有一些戰術方法可以通過它。
And you can rest assured we're implementing those on products like Taltz and others.
您可以放心,我們正在 Taltz 等產品上實施這些功能。
There will be, I think, a toing and froing around these points through time, and we'll compete as we do.
我認為,隨著時間的推移,這些時間點會發生反复,我們將像我們一樣競爭。
I think the bigger issue for the country is, how do we make chronic medications for patients made more affordable for them.
我認為該國更大的問題是,我們如何為患者提供更實惠的慢性藥物。
And again, we go back to the rebate pass-through issue.
再次,我們回到回扣傳遞問題。
That increasing spread is a big issue for patients paying list price with a deductible plan.
對於使用免賠額計劃支付標價的患者來說,這種不斷擴大的價差是一個大問題。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Great.
偉大的。
Thank you, Dave.
謝謝你,戴夫。
Christi?
克里斯蒂?
Christi Shaw - SVP and President of Lilly Bio-Medicines
Christi Shaw - SVP and President of Lilly Bio-Medicines
Yes.
是的。
So, we have a strong history, obviously, in the autoinjector, and that will be our plan from a commercialization standpoint with galcanezumab.
因此,顯然,我們在自動注射器方面有著悠久的歷史,從 galcanezumab 的商業化角度來看,這將是我們的計劃。
Operator
Operator
We'll go to the line of Tony Butler with Guggenheim Partners.
我們將與古根海姆合作夥伴一起前往托尼巴特勒的路線。
Charles Anthony Butler - MD & Senior Equity Analyst
Charles Anthony Butler - MD & Senior Equity Analyst
I wanted to stick with the CGRP, if I may, and simply ask, is this -- would you expect utilization to be principally for those who would be chronic users, a la injection once per month?
如果可以的話,我想堅持使用 CGRP,並簡單地問一下,這是不是 - 您是否希望使用主要針對那些將成為長期用戶的人,每月一次注射一次?
Or do you think that, in fact, there would be a good many episodic users?
或者你認為事實上會有很多情節用戶嗎?
That's question one.
那是問題一。
Number two is, also to the extent that baricitinib has been in Europe, principally Germany, I'm just curious if you have information on both the 2- and 4-milligram use.
第二,巴瑞克替尼在歐洲,主要是德國,我只是好奇你是否有關於 2 和 4 毫克使用的信息。
In other words, can you provide some ratio like 60-40 or some other permutation as to the percentage of use by dose?
換句話說,你能否提供一些比例,如 60-40 或其他一些關於劑量使用百分比的排列?
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Thanks, Tony.
謝謝,托尼。
So Christi, if you'll comment on both these questions, the CGRP, where we expect use to be principally, if that's going to be in chronic or also in episodic.
所以克里斯蒂,如果你對這兩個問題發表評論,CGRP,我們預計主要使用的地方,如果這將是長期的或偶發的。
And then I'm not sure if you have a rabbit to pull out of the hat on the 2- and 4-milligram use in Germany or not.
然後我不確定你是否有一隻兔子可以在德國使用 2 和 4 毫克的帽子。
I don't think we have that information in the IR group so.
我認為我們在 IR 小組中沒有這些信息。
Christi Shaw - SVP and President of Lilly Bio-Medicines
Christi Shaw - SVP and President of Lilly Bio-Medicines
Okay.
好的。
So, we expect most of the uses to be in the preventive, obviously.
因此,顯然,我們希望大多數用途是預防性的。
There's about 4 million to 5 million patients in the U.S. alone that are on preventive medicine.
僅在美國就有大約 400 萬到 500 萬患者正在接受預防醫學治療。
But we also estimate that about 15 million patients could be eligible because they have fallen off their preventive medicine for one reason or the other, efficacy or safety.
但我們還估計,大約 1500 萬患者可能有資格,因為他們出於某種原因(療效或安全性)放棄了預防性藥物。
So, we do expect most of that use to be in chronic.
因此,我們確實希望大部分使用都是慢性的。
The great thing about the Lilly platform is, we're also studying lasmiditan for acute use.
Lilly 平台的偉大之處在於,我們還在研究用於急性使用的 lasmiditan。
And the third thing is, galcanezumab also has a study in cluster headaches.
第三件事是,galcanezumab 也有關於叢集性頭痛的研究。
So, as you look at chronic, episodic, cluster, we expect use across those 2 agents in all 3 areas.
因此,當您查看慢性、偶發性、集群時,我們預計這 2 個代理在所有 3 個領域的使用。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Thank you, Christi.
謝謝你,克里斯蒂。
And Tony, we'll follow up on your question in utilization in Germany that we're seeing between the 2 and the 4-milligram dose.
托尼,我們將跟進您在德國使用的問題,我們在 2 和 4 毫克劑量之間看到。
Christi Shaw - SVP and President of Lilly Bio-Medicines
Christi Shaw - SVP and President of Lilly Bio-Medicines
We can tell you that the majority is at 4 milligrams, just can't give you the split.
我們可以告訴你,大多數是 4 毫克,只是不能給你分開。
Operator
Operator
We'll go to the line of Jeff Holford with Jefferies.
我們將與 Jefferies 一起前往 Jeff Holford。
Jeffrey Holford - Equity Analyst
Jeffrey Holford - Equity Analyst
There seems to be a lot of focus going about on Elanco just I think some concerns that the trend there is maybe unsupportive of that business standing on its own at some point this year.
似乎有很多關注點放在 Elanco 上,只是我認為有些人擔心,今年的某個時候,這種趨勢可能不支持該業務獨立存在。
So, wonder if you can just give us a bit of your thoughts on the longer-term outlook of this.
所以,想知道你是否可以給我們一些關於這個長期前景的想法。
When does this business get more to industry growth rates on the top line, the kind of 5%-plus that we're used to seeing globally for Animal Health?
什麼時候這項業務的收入增長率會更高,我們習慣於在全球動物保健領域看到 5% 以上的增長率?
And what -- maybe what kind of basis point opportunity you see on the margin in the midterm as the mix evolves and it gets more efficient.
還有什麼——也許你在中期看到什麼樣的基點機會,隨著組合的發展和效率的提高。
And then just second quick question on Taltz.
然後是關於 Taltz 的第二個快速問題。
What kind of impact are you seeing in the market really from Tremfya and also on some of the Cosentyx price adjustments.
Tremfya 以及 Cosentyx 的一些價格調整對市場產生了什麼樣的影響。
I think Novartis were commenting they're still being reasonably aggressive on price with that product through 2018.
我認為諾華公司評論說他們在 2018 年之前對該產品的價格仍然相當激進。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Thanks for the questions, Jeff.
謝謝你的問題,傑夫。
So our Jeff, would you comment please on Elanco trends that you see going forward and outlook for longer-term growth as well as margin expansion?
那麼我們的傑夫,您能否就您看到的 Elanco 趨勢以及長期增長和利潤率擴張的前景發表評論?
Dave, feel free to comment if you like.
戴夫,如果您願意,請隨時發表評論。
And then Christi, if you'd like to comment on the impact of Tremfya and some of the pricing dynamics in the IL-17 class.
然後克里斯蒂,如果您想評論 Tremfya 的影響以及 IL-17 類的一些定價動態。
Jeff?
傑夫?
Jeffrey N. Simmons - SVP and President of Elanco Animal Health
Jeffrey N. Simmons - SVP and President of Elanco Animal Health
Yes, we've noted, Jeff, good question.
是的,我們注意到了,傑夫,好問題。
We've had really 3 priorities to our strategy as we go forward, and we are definitely keeping this in context as we go forward.
在我們前進的過程中,我們的戰略確實有 3 個優先事項,並且在我們前進的過程中,我們肯定會在上下文中保持這一點。
The assessment is: one, accelerating innovation; two is changing our mix to higher growth and margin segments; and three, this margin expansion plan, those being the 3. I think as Dave noted, we feel very good about our pipeline and launching products that we're in the midst of right now.
評估為:一、加快創新;二是將我們的組合轉變為更高增長和利潤率的細分市場;第三,這個利潤率擴張計劃,就是第三個。我認為正如戴夫所說,我們對我們的管道和推出我們目前正在進行的產品感覺非常好。
That will be what will return us to, we believe, higher-quality growth and higher margins going forward.
我們相信,這將使我們在未來實現更高質量的增長和更高的利潤率。
So, as I've noted, it will be flat to slightly growing in '18, and we continue to see that increasing going forward.
因此,正如我所指出的,它在 18 年將持平或略有增長,而且我們將繼續看到這種增長。
I think the margin expansion story is a significant one.
我認為利潤率擴張的故事很重要。
There's really a couple of parts to that.
這真的有幾個部分。
One is just cost initiatives.
一是成本舉措。
And we've pulled most of the key levers that we see here in the near and medium term as well as our footprint.
我們已經拉動了我們在近期和中期看到的大部分關鍵槓桿以及我們的足跡。
So, we have announced 2 things this year, continuing to look at rightsizing our footprint after the integration, so with the Larchwood consolidation as well as Augusta, and I think the bST assessment will help.
所以,我們今年宣布了兩件事,在整合後繼續考慮調整我們的足跡,所以隨著 Larchwood 的整合以及奧古斯塔,我認為 bST 評估會有所幫助。
We hit $1 billion in companion animals in 2017 for the first time.
2017 年,我們的伴侶動物首次達到 10 億美元。
And I think just the example of the contrast of bST to the companion animals is a demonstration of this mix change.
而且我認為僅 bST 與伴侶動物對比的例子就是這種混合變化的證明。
So, we have said very clearly on margins that we do see, as we said in December 15 at the investor conference, returning to 30% operating margins, albeit it will be taking a little bit longer given some of these forces like clean food, but we do see a path to that margin expansion.
因此,正如我們在 12 月 15 日的投資者會議上所說的那樣,我們已經非常清楚地說明了我們確實看到的利潤率,恢復到 30% 的營業利潤率,儘管考慮到清潔食品等其中一些因素,這需要更長的時間,但我們確實看到了利潤率擴張的道路。
So increasing as we go forward in the short and medium term.
所以隨著我們在中短期內的發展而增加。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Thanks, Jeff.
謝謝,傑夫。
Christi?
克里斯蒂?
Christi Shaw - SVP and President of Lilly Bio-Medicines
Christi Shaw - SVP and President of Lilly Bio-Medicines
Yes.
是的。
So, Tremfya has had a similar launch uptake as what we've seen with other biologics in the psoriasis space.
因此, Tremfya 與我們在銀屑病領域的其他生物製劑中看到的情況相似。
And as we've said before, we believe that the newer agents and what we're seeing in the marketplace is the newer agents are really increasing expectations of physicians, of patients to ensure -- to really switch patients more quickly from older agents to the newer ones.
正如我們之前所說,我們相信較新的藥物以及我們在市場上看到的是,較新的藥物確實提高了醫生和患者的期望,以確保 - 真正更快地將患者從舊藥物轉換為較新的。
In fact, the last 2 years, the market growth has been 15%, unlike the years before where it was single digits.
事實上,過去 2 年,市場增長率為 15%,與前幾年的個位數不同。
So, we think that's a good thing.
所以,我們認為這是一件好事。
And then on the Cosentyx price adjustment, we continue to look very closely at that.
然後關於 Cosentyx 的價格調整,我們繼續密切關注。
What we've seen and what we saw at launch is in spite of not having great access because patients actually cycle off routinely, go from one agent to another, we haven't had to utilize that piece.
儘管沒有很好的訪問權限,但我們所看到的以及我們在發佈時看到的情況是,因為患者實際上會定期循環,從一個代理轉到另一個代理,我們不必使用該部分。
But we'll continue to keep an eye on it and ensure that we continue to give access for patients who want PASI 100 clear skin scores.
但我們將繼續關注它,並確保我們繼續為希望獲得 PASI 100 透明皮膚評分的患者提供訪問權限。
Operator
Operator
We'll go to the line of Alex Arfaei with BMO Capital.
我們將與 BMO Capital 一起前往 Alex Arfaei 的路線。
Alex Arfaei - Pharmaceuticals Analyst
Alex Arfaei - Pharmaceuticals Analyst
Three, if I may.
三,如果可以的話。
First, could you comment on the specific milestone achieved for your N3pG antibody in Alzheimer's?
首先,您能否評論一下您的 N3pG 抗體在阿爾茨海默病中取得的具體里程碑?
Was there a specific efficacy or safety hurdle that was met?
是否遇到了特定的功效或安全障礙?
Second, on Basaglar, do you expect -- when do you expect additional insulin -- basal insulin biosimilars?
其次,關於 Basaglar,您是否期望 - 您何時期望額外的胰島素 - 基礎胰島素生物仿製藥?
And when should we expect interchangeability data for Basaglar?
我們什麼時候應該期待 Basaglar 的互換性數據?
Is that something that you're pursuing?
那是你追求的東西嗎?
And then third, to follow up on your comments on rebate pass-through utilizations, which makes a lot of sense, we're hearing similar comments from other pharma leaders.
第三,為了跟進您對回扣直通利用的評論,這很有意義,我們聽到其他製藥業領導者的類似評論。
Since you seem to be involved in the policy discussions, what are your expectations of this actually happening, whether it's in the Part D or the commercial setting?
既然您似乎參與了政策討論,那麼您對這實際發生的期望是什麼,無論是在 D 部分還是商業環境中?
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Alex, thank you for the questions.
亞歷克斯,謝謝你的問題。
So Jan, if you'd like to comment on the specific milestone that was achieved for us to be now showing the N3pG in that Phase II column.
所以 Jan,如果您想對我們現在在 II 期專欄中展示 N3pG 所取得的具體里程碑發表評論。
Enrique, on the additional competition, when that might come in from our understanding for Basaglar and if we're pursuing interchangeability and producing data for that.
Enrique,關於額外的競爭,這可能來自我們對 Basaglar 的理解,以及我們是否正在追求可互換性並為此生成數據。
And then Dave, on the likelihood of some of those rebate pass-throughs being enacted in either the government or commercial spaces.
然後是戴夫,關於在政府或商業空間中實施其中一些回扣傳遞的可能性。
Jan?
簡?
Jan M. Lundberg - Executive VP of Science & Technology and President of Lilly Research Laboratories
Jan M. Lundberg - Executive VP of Science & Technology and President of Lilly Research Laboratories
Well, without being too specific on numbers here, then I can say that the N3pG studies then met our criteria for reducing the amyloid imaging signal in Alzheimer's patients.
好吧,這裡的數字不用太具體,那麼我可以說 N3pG 研究符合我們減少阿爾茨海默病患者澱粉樣蛋白成像信號的標準。
And secondly, we have a dose regimen that seems safe in spite of having some immunogenicity.
其次,儘管具有一定的免疫原性,但我們有一種似乎安全的劑量方案。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Thank you, Jan.
謝謝你,簡。
Enrique?
恩里克?
Enrique A. Conterno - SVP, President of Lilly Diabetes and President of Lilly USA
Enrique A. Conterno - SVP, President of Lilly Diabetes and President of Lilly USA
So, some of the additional entrants into the basal space are held up right now due to litigation.
因此,由於訴訟,一些進入基礎空間的額外進入者現在被擱置了。
I think that is a question really for them and for Sanofi.
我認為這對他們和賽諾菲來說都是一個問題。
As it relates to interchangeability, we think this will eventually happen.
由於它與可互換性有關,我們認為這最終會發生。
The right studies will need to be conducted, but I view these as years away.
需要進行正確的研究,但我認為這些都是幾年後的事情。
There's nothing imminent.
沒有什麼迫在眉睫的事。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Great.
偉大的。
Thank you.
謝謝你。
Dave?
戴夫?
David A. Ricks - Chairman, CEO & President
David A. Ricks - Chairman, CEO & President
Yes.
是的。
Rebate pass-through, it's good everyone's talking about it because it should happen.
回扣傳遞,大家都在談論它很好,因為它應該發生。
In fact, it already is happening in commercial plans.
事實上,它已經在商業計劃中發生。
I know that because we're executing it in our plan.
我知道這一點,因為我們正在計劃中執行它。
And I know other large employers are as well.
我知道其他大型雇主也是如此。
It's not happening in Part D. We've got the proposal on the table.
D 部分沒有發生這種情況。我們已將提案擺在桌面上。
CMS put out the proposed regs for comment in the fall.
CMS 在秋季發布了擬議的法規以徵求意見。
And I think a number of centers and others have weighed in on that.
我認為一些中心和其他人已經對此進行了權衡。
There is a push and pull there between, should we allow a modest increase in premiums in Part D to support the funding of rebate pass-through.
如果我們允許 D 部分中的保費適度增加以支持回扣傳遞的資金,那麼兩者之間存在推和拉。
Now we're for that because, of course, not passing through the rebates subjects the very ill to the cost burden versus spreading that over a much larger base.
現在我們支持這一點,因為當然,不通過回扣會使成本負擔非常重,而不是將其分散到更大的基礎上。
We think that's what insurance is for.
我們認為這就是保險的用途。
And therefore, we advocate for it.
因此,我們提倡它。
It's difficult to speculate on the probability of that happening, but I can tell you there's strong unanimity amongst large manufacturers.
很難推測發生這種情況的可能性,但我可以告訴你,大型製造商之間有很強的一致性。
It is a serious proposal being looked at in both the Hill and HHS.
這是一個在希爾和 HHS 都在考慮的嚴肅提案。
And to me, it is one of the simplest levers to pull to actually change the cost to the pharmacy counter for drugs in America.
對我來說,這是改變美國藥房櫃檯成本的最簡單的槓桿之一。
And I think the U.S. should do it.
我認為美國應該這樣做。
That doesn't mean it will happen though.
但這並不意味著它會發生。
So, we'll have to stay close to that one, and we'll keep you updated.
因此,我們將不得不靠近那個,我們會及時通知您。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Great.
偉大的。
Thank you, Dave.
謝謝你,戴夫。
Operator
Operator
And our final question comes from the line of Steve Scala with Cowen.
我們的最後一個問題來自 Steve Scala 和 Cowen 的對話。
Stephen Michael Scala - MD and Senior Research Analyst
Stephen Michael Scala - MD and Senior Research Analyst
Jeff, you mentioned a few times mix change in 2018.
Jeff,你在 2018 年提到過幾次混音變化。
Can you be more specific?
你可以說得更詳細點嗎?
And do you see any risks or opportunities in food animal business related to either NAFTA or TPP?
您是否看到與 NAFTA 或 TPP 相關的食用動物業務存在任何風險或機遇?
And secondly, baricitinib completed a Phase II SLE study in December.
其次,巴瑞替尼在 12 月完成了一項 II 期 SLE 研究。
Can you provide any thoughts on what you saw?
你能就你所看到的提供任何想法嗎?
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Steve, thank you for the questions.
史蒂夫,謝謝你的提問。
So Jeff, you can comment on the mix change for '18 and opportunity that some of the trade agreements could have potentially in our food animal business.
所以傑夫,你可以評論一下 18 年的混合變化以及一些貿易協定可能在我們的食用動物業務中帶來的機會。
And then Christi, for the baricitinib question.
然後是克里斯蒂,關於巴瑞替尼的問題。
Jeffrey N. Simmons - SVP and President of Elanco Animal Health
Jeffrey N. Simmons - SVP and President of Elanco Animal Health
Thanks, Steve.
謝謝,史蒂夫。
Just to note, I would say that we continue to be very intentional on starting back in our pipeline is to really focus on these higher-growth areas.
需要注意的是,我想說我們繼續非常有意識地重新開始我們的管道是真正專注於這些高增長領域。
And we've been very open.
我們一直非常開放。
All of companion animals, we see we can compete in the 3 major segments there, then vaccines, antibiotic alternatives and nutritional health.
所有的伴侶動物,我們看到我們可以在三個主要領域競爭,然後是疫苗、抗生素替代品和營養健康。
These are the areas that we're intentionally leaning in on from our pipeline all the way through.
這些是我們一直有意從我們的管道中傾斜的領域。
And then when I look at accelerating our mix, I guess I would note, I mean, what really drove primarily the decline in our food animal business in the U.S. this year was bST.
然後,當我考慮加速我們的組合時,我想我會注意到,我的意思是,真正推動我們今年在美國的食用動物業務下降的是 bST。
We did see the clean food movement hit us at an accelerated rate, but we've got bST now representing less than 5% of our portfolio.
我們確實看到清潔食品運動以更快的速度衝擊著我們,但我們現在的 bST 僅占我們產品組合的不到 5%。
So it gives you an idea of that change.
因此,它使您對這種變化有所了解。
And that's all I would speak to specifically, but we are looking at antibiotic alternatives, vaccines, nutritional health on the food side, and we see some nice growth going forward there.
這就是我要特別談的,但我們正在研究食品方面的抗生素替代品、疫苗、營養健康,我們看到那裡有一些不錯的增長。
No, I don't see anything on the trade side.
不,我在貿易方面看不到任何東西。
Trade's critical.
貿易至關重要。
We all know that.
我們都知道。
We built in our assumptions.
我們建立了我們的假設。
There's no trade agreements or changes that we see impacting any of our portfolio going forward.
我們認為沒有任何貿易協議或變化會影響我們未來的任何投資組合。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Thank you, Jeff.
謝謝你,傑夫。
Christi?
克里斯蒂?
Christi Shaw - SVP and President of Lilly Bio-Medicines
Christi Shaw - SVP and President of Lilly Bio-Medicines
Yes.
是的。
So, we're very pleased with the Phase II data with lupus.
因此,我們對狼瘡的 II 期數據感到非常滿意。
We'll be disclosing that data at a major medical meeting this year.
我們將在今年的一次重要醫學會議上披露這些數據。
And we're evaluating options to actually start a Phase III by the end of 2018.
我們正在評估在 2018 年底之前實際啟動第三階段的選項。
Philip Johnson - VP for IR
Philip Johnson - VP for IR
Great.
偉大的。
Thank you very much.
非常感謝。
That does exhaust the queue and a few minutes early before the bottom of the hour here.
這確實耗盡了隊列,並且比這裡的小時底早了幾分鐘。
Dave, would you like to go ahead and close the call?
戴夫,你想繼續並結束通話嗎?
David A. Ricks - Chairman, CEO & President
David A. Ricks - Chairman, CEO & President
Sure.
當然。
Thanks, Phil, and thank you to all of you.
謝謝,菲爾,謝謝你們所有人。
We appreciate your participation in today's earnings call and your interest in Eli Lilly and Company.
感謝您參加今天的財報電話會議以及您對禮來公司的興趣。
In 2017, we generated strong revenue growth, driven by our new human pharmaceutical products.
2017 年,在我們新的人用醫藥產品的推動下,我們實現了強勁的收入增長。
We significantly improved margins leading to even faster income growth.
我們顯著提高了利潤率,從而實現了更快的收入增長。
As we move into 2018, we expect to see continued growth of our new pharmaceutical products and significant additional margin expansion.
隨著我們進入 2018 年,我們預計我們的新醫藥產品將繼續增長,並顯著增加利潤率。
We believe Lilly -- the Lilly stock remains a compelling investment given the strength of our product portfolio, our top and bottom line growth prospects over the balance of the decade.
我們相信禮來(Lilly)——鑑於我們的產品組合的實力、我們在十年餘下時間的營收和利潤增長前景,禮來股票仍然是一項引人注目的投資。
Today, I'd also like to thank Chris Ogden.
今天,我還要感謝克里斯·奧格登。
This will be his last earnings call in his current capacity, and really thank him for his considerable contributions over the last few years to the IR efforts.
這將是他以目前身份參加的最後一次財報電話會議,非常感謝他在過去幾年中對 IR 工作做出的巨大貢獻。
Please follow-up with our IR team if you have any questions we didn't address on today's call.
如果您有任何我們在今天的電話會議中沒有解決的問題,請與我們的 IR 團隊聯繫。
That concludes the call.
這結束了通話。
Have a great day.
祝你有美好的一天。
Operator
Operator
Thank you.
謝謝你。
And ladies and gentlemen, this conference will be available for replay after 11:30 today through January 31, 2019.
女士們,先生們,本次會議將於今天 11:30 後至 2019 年 1 月 31 日期間重播。
You may access the AT&T teleconference replay system at any time by dialing 1 (800) 67 -- I apologize, 1 (800) 475-6701 and entering the access code 442374.
您可以隨時撥打 1 (800) 67 訪問 AT&T 電話會議重播系統 -- 抱歉,請撥打 1 (800) 475-6701 並輸入訪問代碼 442374。
International participants, dial (320) 365-3844.
國際參與者,請撥打 (320) 365-3844。
That does conclude our conference for today.
這確實結束了我們今天的會議。
Thank you for your participation and for using AT&T Executive TeleConference Service.
感謝您的參與和使用 AT&T 行政電話會議服務。
You may now disconnect.
您現在可以斷開連接。