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Operator
Operator
Ladies and gentlemen, thank you for standing by, and welcome to the Eli Lilly Q1 2017 Earnings Call.
女士們先生們,感謝您的支持,歡迎參加禮來公司 2017 年第一季度財報電話會議。
(Operator Instructions)
(操作員說明)
As a reminder, today's call is being recorded.
提醒一下,今天的電話正在錄音中。
I'll turn the conference now over to your host, Mr. Dave Ricks.
我現在將會議轉交給您的主持人戴夫·里克斯先生。
Please go ahead, sir.
請繼續,先生。
David A. Ricks - CEO, President and Director
David A. Ricks - CEO, President and Director
Good morning.
早上好。
Thank you for joining Eli Lilly and Company's First Quarter 2017 Earnings Call.
感謝您參加禮來公司 2017 年第一季度財報電話會議。
I'm Dave Ricks, Lilly's President and CEO.
我是禮來公司總裁兼首席執行官戴夫·里克斯。
Joining me on today's call are Derica Rice, our Chief Financial Officer; Dr. Jan Lundberg, President of Lilly Research Labs; Enrique Conterno, President of Lilly Diabetes and Lilly USA; Dr. Sue Mahony, President of Lilly Oncology; Jeff Simmons, President of Elanco Animal Health; and I'd like to extend a special welcome to Christi Shaw, who joined us earlier this month as President of Lilly Bio-Medicines.
今天和我一起參加電話會議的是我們的首席財務官德里卡·賴斯(Derica Rice);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; Elanco Animal Health 總裁 Jeff Simmons;我要特別歡迎本月早些時候加入我們擔任禮來生物醫藥總裁的 Christi Shaw。
We're also joined by Kristina Wright, Chris Ogden and Phil Johnson of the IR team.
IR 團隊的 Kristina Wright、Chris Ogden 和 Phil Johnson 也加入了我們的行列。
During this conference call, we anticipate making projections and forward-looking statements based on our current expectations.
在這次電話會議期間,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。
Information we provide about our products and pipeline is for the benefit of the investment community.
我們提供的有關我們的產品和管道的信息是為了投資界的利益。
It is not intended to be promotional, and it is not sufficient for prescribing physicians.
它不是為了促銷,也不足以為醫生開處方。
Before discussing key events for the quarter, I'll start with a summary of our progress on our strategic objectives since our earnings call in January.
在討論本季度的關鍵事件之前,我將首先總結自 1 月份財報電話會議以來我們在戰略目標方面取得的進展。
Starting with grow revenue.
從增加收入開始。
Q1, we generated worldwide revenue growth of 7%, which was driven by 9% volume growth in our pharmaceutical business, led by our new products.
第一季度,我們在全球範圍內實現了 7% 的收入增長,這是由我們的新產品帶動的製藥業務量增長 9% 推動的。
On our strategic objective of expand margins, our non-GAAP gross margin percent, excluding the effect of FX on international inventories sold, increased by nearly 220 basis points compared to Q1 2016.
在我們擴大利潤率的戰略目標方面,我們的非美國通用會計準則毛利率百分比(不包括外匯對已售國際庫存的影響)與 2016 年第一季度相比增加了近 220 個基點。
And total operating expenses as a percent of revenue also declined by nearly 220 basis points.
總運營費用佔收入的百分比也下降了近 220 個基點。
Under the heading of sustaining the flow of innovation, we launched baricitinib under the tradename Olumiant in Europe for rheumatoid arthritis, while here in the U.S., we were disappointed to receive a Complete Response Letter from the FDA for baricitinib in RA.
在維持創新流動的標題下,我們在歐洲以商品名 Olumiant 推出了用於類風濕性關節炎的 baricitinib,而在美國,我們很失望地收到 FDA 對 baricitinib 用於 RA 的完整回复信。
We remain confident of the benefit/risk of baricitinib as a new treatment option for adults with moderate to severe rheumatoid arthritis, and we will work with the FDA to determine a path forward to ultimately bring baricitinib to patients in the U.S.
我們仍然對巴瑞克替尼作為中度至重度類風濕性關節炎成人的新治療選擇的益處/風險充滿信心,我們將與 FDA 合作確定最終將巴瑞替尼帶給美國患者的前進道路。
And as I'll discuss in more detail later, we had a positive Phase III readouts for abemaciclib, for Taltz and for Cyramza.
正如我稍後將更詳細地討論的那樣,我們對 abemaciclib、Taltz 和 Cyramza 有一個積極的 III 期讀數。
Finally, on deploying capital to create value, we completed the acquisition of CoLucid Pharmaceuticals, which adds lasmiditan for acute migraine to our late-stage pipeline.
最後,在利用資本創造價值方面,我們完成了對 CoLucid Pharmaceuticals 的收購,這為我們的後期管道添加了用於急性偏頭痛的 lasmiditan。
And we returned over $500 million to shareholders via our dividends.
我們通過股息向股東返還了超過 5 億美元。
Our continued progress in 2017 keeps us on track to achieve our midterm goals for each of our strategic objectives.
我們在 2017 年繼續取得進展,使我們能夠實現每個戰略目標的中期目標。
Now let's move to Slide 5 for a more detailed review of the key events that occurred during our -- since our last earnings call.
現在讓我們轉到幻燈片 5,更詳細地回顧自上次財報電話會議以來發生的關鍵事件。
On the commercial front, here in the U.S., in collaboration with Boehringer Ingelheim, we launched Synjardy XR, a once-daily combination tablet containing empagliflozin and extended-release metformin for the treatment of adults with type 2 diabetes.
在商業方面,在美國,我們與勃林格殷格翰合作推出了 Synjardy XR,這是一種每日一次的組合片劑,含有恩格列淨和二甲雙胍緩釋片,用於治療成人 2 型糖尿病。
As I mentioned earlier, we launched Olumiant in Europe for the treatment of moderate-to-severe rheumatoid arthritis following European Commission approval earlier this year.
正如我之前提到的,在今年早些時候歐盟委員會批准後,我們在歐洲推出了用於治療中度至重度類風濕性關節炎的 Olumiant。
On the regulatory front, U.S. FDA issued a Complete Response Letter for baricitinib for rheumatoid arthritis.
在監管方面,美國 FDA 發布了一份針對 baricitinib 治療類風濕性關節炎的完整回复信。
The letter indicated that the FDA was unable to approve the application in its current form.
這封信表明,FDA 無法批准目前形式的申請。
Specifically, the FDA indicated that additional clinical data are needed to determine the most appropriate doses and to further characterize safety concerns.
具體而言,FDA 表示需要額外的臨床數據來確定最合適的劑量並進一步描述安全問題。
Lilly and Incyte disagreed with the agency's conclusion, and we look forward to meeting with the FDA in the coming months to determine appropriate next steps.
Lilly 和 Incyte 不同意該機構的結論,我們期待在未來幾個月內與 FDA 會面,以確定適當的下一步措施。
We'll provide you a status update after we meet with the FDA.
我們會在與 FDA 會面後為您提供狀態更新。
Also here in the U.S., the FDA approved an update to the Trulicity label to include use in combination with basal insulin for adults with type 2 diabetes.
同樣在美國,FDA 批准了對 Trulicity 標籤的更新,包括與基礎胰島素聯合用於成人 2 型糖尿病。
And in Europe, along with Boehringer Ingelheim, we received European Commission approval of an update to the Synjardy label to include a change to the indication statement as well as data from the EMPA-REG OUTCOME trial on the reduction of cardiovascular death.
在歐洲,我們與勃林格殷格翰一起獲得了歐盟委員會對 Synjardy 標籤更新的批准,其中包括對適應症聲明的更改以及來自 EMPA-REG OUTCOME 減少心血管死亡試驗的數據。
On the clinical front, we announced that MONARCH 2, in a Phase III trial abemaciclib in combination with fulvestrant in women with HR+, HER2- breast cancer met its primary endpoint of approved progression-free survival.
在臨床方面,我們宣布 MONARCH 2,在一項 III 期試驗中,abemaciclib 與氟維司群聯合治療 HR+、HER2-乳腺癌患者,達到了批准的無進展生存期的主要終點。
We look forward to presenting data from the study at ASCO in early June, and we'll hold a call the evening of Saturday, June 3, to discuss these results with the investment community.
我們期待在 6 月初在 ASCO 上展示這項研究的數據,我們將在 6 月 3 日星期六晚上召開電話會議,與投資界討論這些結果。
Finally, we've decided to move FDA submission of MONARCH 2 from the previously announced timing of Q3 up into Q2.
最後,我們決定將 FDA 提交的 MONARCH 2 從之前宣布的第三季度時間移至第二季度。
And just yesterday, we announced that MONARCH -- the MONARCH 3 study for abemaciclib met its primary endpoint at an interim analysis demonstrating that women with HR+, HER2- advanced breast cancer who had not receive prior systemic therapy experienced a statistically significant improvement in PFS when treated with abemaciclib plus an aromatase inhibitor compared to placebo plus an aromatase inhibitor.
就在昨天,我們宣布 MONARCH——abemaciclib 的 MONARCH 3 研究在一項中期分析中達到了其主要終點,表明未接受過先前全身治療的 HR+、HER2-晚期乳腺癌女性在與安慰劑加芳香酶抑製劑相比,用 abemaciclib 加芳香酶抑製劑治療。
Improvement was also shown in a key secondary endpoint of objective response rate.
客觀反應率的關鍵次要終點也顯示出改善。
We intend to begin global regulatory submissions of these results in Q3 2017.
我們打算在 2017 年第三季度開始向全球監管機構提交這些結果。
For the RAINFALL study of ramucirumab in first-line gastric cancer, the Independent Data Monitoring Committee recently met to review the primary analysis.
對於雷莫蘆單抗治療一線胃癌的 RAINFALL 研究,獨立數據監測委員會最近開會審查了初步分析。
While we remain blinded to the data, we're pleased to report that the IDMC stated that the study met its primary endpoint of improved progression-free survival.
雖然我們仍然對數據視而不見,但我們很高興地報告 IDMC 表示該研究達到了改善無進展生存期的主要終點。
Consistent with our prior communication, our expectation remains that regulatory submissions could occur after we have the final overall survival data in 2018.
與我們之前的溝通一致,我們仍然期望在 2018 年獲得最終的總體生存數據後提交監管文件。
At the American Academy of Dermatology meeting, we presented Phase III data showing that patients with moderate-to-severe plaque psoriasis treated with ixekizumab, or Taltz, demonstrated superior efficacy at 24 weeks compared to patients treated with Stelara.
在美國皮膚病學會會議上,我們提交的 III 期數據顯示,與接受 Stelara 治療的患者相比,接受 ixekizumab 或 Taltz 治療的中度至重度斑塊狀銀屑病患者在 24 週時表現出更好的療效。
And along with Boehringer Ingelheim, we initiated 2 Phase III studies of Jardiance for the treatment of chronic heart failure.
我們與勃林格殷格翰一起啟動了 Jardiance 治療慢性心力衰竭的 2 項 III 期研究。
These trials will enroll patients with and without diabetes and with both preserved as well as reduced ejection fraction heart failure.
這些試驗將招募患有和未患有糖尿病以及射血分數心力衰竭和射血分數降低的患者。
Moving to Slide 6. As I mentioned earlier, in business development news, we completed the addition of CoLucid Pharmaceuticals.
轉到幻燈片 6。正如我之前提到的,在業務發展新聞中,我們完成了 CoLucid Pharmaceuticals 的添加。
In other news, in Japan, the IP High Court ruled in our favor in the invalidation trials initiated by Sawai regarding our vitamin regimen patents for Alimta.
在其他新聞中,在日本,知識產權高等法院在 Sawai 發起的關於我們為 Alimta 的維生素方案專利的無效審判中作出了有利於我們的裁決。
If the patents are ultimately upheld through all the challenges, they could provide intellectual property protection for Alimta in Japan until June of 2021.
如果這些專利最終在所有挑戰中得到維護,它們可以為日本的 Alimta 提供知識產權保護,直到 2021 年 6 月。
To support the increased demand for our products in our pipeline, we announced plans to invest $850 million in our U.S. operations in 2017, including research laboratories, manufacturing facilities and some administrative areas.
為支持我們在研產品不斷增長的需求,我們宣布計劃在 2017 年向我們的美國業務投資 8.5 億美元,包括研究實驗室、製造設施和一些行政區域。
We also distributed over $500 million to shareholders via the dividend.
我們還通過股息向股東分配了超過 5 億美元。
Now I'll turn the call over to Phil for a discussion of our financial performance for the quarter.
現在我將把電話轉給菲爾,討論我們本季度的財務業績。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Great.
偉大的。
Thanks, Dave.
謝謝,戴夫。
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 earnings press release for a detailed description of the year-on-year changes in our first quarter GAAP results.
我將把我的評論集中在我們的非 GAAP 調整措施上,以深入了解我們業務的潛在趨勢,因此請參閱今天的收益新聞稿,詳細描述我們第一季度 GAAP 業績的同比變化.
Looking at the non-GAAP measures on Slide 9, you can see that Q1 2017 revenue increased 7% compared to Q1 2016, reaching $5.2 billion.
查看幻燈片 9 上的非 GAAP 指標,您可以看到 2017 年第一季度的收入與 2016 年第一季度相比增長了 7%,達到 52 億美元。
Gross margin as a percent of revenue was 78.1%, an increase of 180 basis points over Q1 2016.
毛利率佔收入的百分比為 78.1%,比 2016 年第一季度增加了 180 個基點。
The effect of foreign exchange rates on international inventory sold resulted in a benefit to both this year's and last year's quarter, with the benefit being slightly larger last year.
外匯匯率對國際庫存銷售的影響對今年和去年的季度都有好處,去年的好處略大。
Excluding this FX effect, our gross margin percent increased by nearly 220 basis points, going from 74.9% in last year's quarter to 77.1% in this quarter, driven by manufacturing efficiencies.
排除這種外匯影響,在製造效率的推動下,我們的毛利率百分比增加了近 220 個基點,從去年同期的 74.9% 上升到本季度的 77.1%。
Total operating expense increased 3% compared to Q1 of 2016.
與 2016 年第一季度相比,總運營費用增加了 3%。
This increase is lower than the increase in revenue, leading total operating expense as a percent of revenue to decline by nearly 220 basis points to 53.2%.
這一增長低於收入的增長,導致總運營費用佔收入的百分比下降近 220 個基點至 53.2%。
Looking at the component parts of total operating expense, marketing, selling and administrative expenses increased 5%, while R&D expenses increased just 1%.
從總運營費用的組成部分來看,營銷、銷售和管理費用增長了 5%,而研發費用僅增長了 1%。
In marketing, selling and administrative expenses, higher spending to support new products was partially offset by lower spending on late life-cycle products.
在營銷、銷售和管理費用方面,支持新產品的較高支出被後期生命週期產品的較低支出部分抵消。
Other income and expense was income of $15 million this quarter compared to $55 million reported in last year's quarter.
本季度其他收入和支出為 1500 萬美元,而去年同期為 5500 萬美元。
Our tax rate was 21.2%, an increase of 3.3 percentage points compared to the same quarter last year.
我們的稅率為21.2%,比去年同期提高了3.3個百分點。
This increase was primarily due to the net discrete tax benefit of approximately $50 million in last year's Q1.
這一增長主要是由於去年第一季度約 5000 萬美元的淨離散稅收收益。
At the bottom line, net income and earnings per share both increased 18%.
歸根結底,淨收入和每股收益均增長了 18%。
We achieved this significant earnings growth by delivering high single-digit volume-based revenue growth while improving our gross margin percent and reducing our OpEx percent, creating positive leverage.
我們通過實現基於數量的高個位數收入增長,同時提高我們的毛利率和降低我們的運營支出百分比,創造了積極的槓桿作用,實現了這一顯著的收益增長。
Slide 10 provides a reconciliation between reported and non-GAAP EPS, and you'll find additional details on these adjustments on Slide 22.
幻燈片 10 提供了報告和非公認會計原則每股收益之間的對賬,您可以在幻燈片 22 中找到有關這些調整的更多詳細信息。
Now let's take a look at the effect of price, rate and volume on revenue growth.
現在讓我們來看看價格、費率和數量對收入增長的影響。
On Slide 11, in the gray highlighted row at the bottom of the table, you'll see the 7% revenue growth I mentioned earlier.
在幻燈片 11 中,在表格底部灰色突出顯示的行中,您將看到我之前提到的 7% 的收入增長。
The effect of foreign exchange on revenue growth was minimal this quarter.
本季度外匯對收入增長的影響微乎其微。
And excluding the slight headwind from FX, our worldwide revenue growth on a performance basis was 8% and was driven entirely by volume.
排除外匯帶來的輕微不利因素,我們的全球收入增長為 8%,完全由銷量驅動。
By geography, you'll notice that U.S. pharma revenue increased 16%, driven primarily by 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 16%,主要是受銷量的推動。
Trulicity was the main driver of U.S. volume growth, with meaningful contributions also coming from Taltz and Lartruvo.
Trulicity 是美國銷量增長的主要推動力,Taltz 和 Lartruvo 也做出了有意義的貢獻。
The decline in European human pharmaceutical revenue of 5% was driven by the negative effect of price and unfavorable foreign exchange movements, partially offset by higher volume.
歐洲人用藥品收入下降 5% 是由於價格的負面影響和不利的外匯走勢,部分被銷量增加所抵消。
On a constant-currency or performance basis, European revenue decreased 1%.
按固定匯率或業績計算,歐洲收入下降 1%。
This performance decrease was driven primarily by Cymbalta and Alimta, partially offset by the uptake of new products, led by Trulicity.
這種業績下降主要是由 Cymbalta 和 Alimta 推動的,部分被 Trulicity 領導的新產品的吸收所抵消。
In Japan, despite a large negative impact from the entry of generic Zyprexa last June, pharma revenue increased 5%.
在日本,儘管去年 6 月仿製藥 Zyprexa 的進入產生了巨大的負面影響,但製藥收入增長了 5%。
This increase was driven by a 6% benefit from higher volumes, and to a lesser extent, from a stronger yen, partially offset by a 4% negative price effect from last year's biannual price cuts.
這一增長是由於銷量增加帶來了 6% 的收益,而日元走強則在較小程度上受到了推動,這部分被去年一年兩次的降價帶來的 4% 的負面價格影響所抵消。
On a constant-currency basis, Japan pharma revenue increased 3%, while excluding Zyprexa, Japan pharma revenue in Q1 grew 16% on a constant-currency basis, led by Cyramza with meaningful contributions from Cymbalta and Trulicity.
按固定匯率計算,日本製藥收入增長 3%,而剔除 Zyprexa 的情況下,日本第一季度製藥收入按固定匯率計算增長 16%,其中 Cyramza 領先,Cymbalta 和 Trulicity 做出了有意義的貢獻。
Turning to our pharma revenue in the rest of world, or ROW, revenue this quarter increased 2% as volume growth of 7% was largely offset by lower prices and the negative effect of FX.
談到我們在世界其他地區的製藥收入,即 ROW,本季度的收入增長了 2%,因為 7% 的銷量增長在很大程度上被較低的價格和外彙的負面影響所抵消。
On a performance basis, ROW revenue increased 4% as growth in Humalog, Trulicity, Trajenta, Cyramza and Jardiance was partially offset by lower sales of Cymbalta, Alimta and Cialis.
在業績的基礎上,由於 Humalog、Trulicity、Trajenta、Cyramza 和 Jardiance 的增長被 Cymbalta、Alimta 和 Cialis 的銷售額下降部分抵消,ROW 收入增長了 4%。
Turning to animal health.
轉向動物健康。
This quarter, worldwide revenue increased 2%, driven by higher volume for our acquisition of Boehringer Ingelheim Vetmedica's U.S. vaccine business.
本季度,由於我們收購 Boehringer Ingelheim Vetmedica 的美國疫苗業務的交易量增加,全球收入增長了 2%。
The effect of FX as well as price was minimal.
外彙和價格的影響微乎其微。
Excluding the BI Vetmedica vaccines acquisition, the rest of our animal health revenue decreased 3%.
不包括收購 BI Vetmedica 疫苗,我們其餘的動物保健收入下降了 3%。
As we've done in the recent quarters, let's now take a look at the drivers of our worldwide volume growth on Slide 12.
正如我們在最近幾個季度所做的那樣,現在讓我們在幻燈片 12 上看一下我們全球銷量增長的驅動因素。
As I mentioned earlier, excluding FX, our worldwide revenue grew 8% this quarter, driven by an 8% increase in volume.
正如我之前提到的,不包括外匯,本季度我們的全球收入增長了 8%,這得益於銷量增長 8%。
In total, our new products, comprised of Trulicity, Cyramza, Jardiance, Taltz, Basaglar, Lartruvo, Portrazza and now Olumiant in the EU, were again the engine of our worldwide volume growth.
總的來說,我們的新產品,包括 Trulicity、Cyramza、Jardiance、Taltz、Basaglar、Lartruvo、Portrazza 和現在在歐盟的 Olumiant,再次成為我們全球銷量增長的引擎。
You can see that these products drove 10.1 percentage points of volume growth this quarter.
您可以看到,這些產品在本季度推動了 10.1 個百分點的銷量增長。
Humalog contributed 50 basis points, Trajenta contributed 40 basis points and animal health, due to the BI Vetmedica U.S. vaccines acquisition, contributed 30 basis points of volume growth.
Humalog 貢獻了 50 個基點,Trajenta 貢獻了 40 個基點,動物健康由於收購了 BI Vetmedica 美國疫苗,貢獻了 30 個基點的銷量增長。
Lower Cialis volume provided a headwind of 90 basis points, primarily due to lower volume in the U.S., as a result of a decline in the overall ED market as well as increased use of off-label generic sildenafil.
較低的 Cialis 銷量帶來了 90 個基點的阻力,主要是由於整體 ED 市場的下滑以及標籤外仿製藥西地那非的使用增加導緻美國銷量下降。
Alimta trimmed 1.1 percentage points from our volume growth, due primarily to competitive pressure in the U.S., while a loss of exclusivity for Zyprexa, Cymbalta and Evista provided a drag of a 1.8 percentage points.
Alimta 使我們的銷量增長減少了 1.1 個百分點,主要是由於美國的競爭壓力,而 Zyprexa、Cymbalta 和 Evista 的排他性喪失則拖累了 1.8 個百分點。
Now let me turn the call over to Derica.
現在讓我把電話轉給 Derica。
Derica W. Rice - CFO and EVP of Global Services
Derica W. Rice - CFO and EVP of Global Services
Thanks, Phil.
謝謝,菲爾。
As in prior quarters, I'll start by sharing some color on our new product launches.
與前幾個季度一樣,我將首先分享我們新產品發布的一些色彩。
As you can see on the graph on Slide 13, our new products generated over $800 million in revenue this quarter led by Trulicity and Cyramza.
正如您在幻燈片 13 上的圖表中看到的那樣,我們的新產品本季度在 Trulicity 和 Cyramza 的帶領下創造了超過 8 億美元的收入。
This represents over 15% of our total worldwide revenue, up from 12% last quarter.
這占我們全球總收入的 15% 以上,高於上一季度的 12%。
And as Phil mentioned earlier, these products drove 10.1 percentage points of our worldwide volume growth this quarter.
正如菲爾之前提到的,這些產品推動了我們本季度全球銷量增長的 10.1 個百分點。
Trulicity performance continues to be strong and is benefiting from the both growing market share and a rapidly expanding GLP-1 class.
Trulicity 的表現繼續強勁,並受益於不斷增長的市場份額和迅速擴大的 GLP-1 類別。
In the U.S., we're pleased that our new-to-brand share with endocrinologists, which we view as a key leading indicator, is comparable to Victoza.
在美國,我們很高興我們與內分泌學家的新品牌份額(我們認為這是一個關鍵的領先指標)與 Victoza 相當。
We've also recently expanded our efforts to reach primary care physicians and are encouraged by the early results.
我們最近還擴大了接觸初級保健醫生的努力,並對早期結果感到鼓舞。
Cyramza continues to grow globally, driven largely by Japan, where we're seeing strong adoption in gastric cancer and more recently, have seen uptake in both lung and colorectal cancer.
Cyramza 繼續在全球範圍內增長,主要由日本推動,我們看到日本在胃癌中的廣泛採用,最近,在肺癌和結直腸癌中也出現了增長。
OUS markets now account for nearly 2/3 of our worldwide Cyramza sales, and we look forward to continued OUS growth.
OUS 市場現在占我們全球 Cyramza 銷售額的近 2/3,我們期待 OUS 繼續增長。
U.S. Cyramza sales declined this quarter largely due to pressure from IO agents in non-small cell lung cancer.
本季度美國 Cyramza 銷售額下降主要是由於非小細胞肺癌 IO 代理的壓力。
Moving to Jardiance.
搬到Jardiance。
In the U.S., we're pleased that our new-to-therapy share with both endocrinologists and primary care physicians has increased substantially since the FDA approval of the CV indication and the update to the ADA's diabetes treatment guidelines.
在美國,我們很高興自 FDA 批准 CV 適應症和 ADA 糖尿病治療指南更新以來,我們與內分泌科醫生和初級保健醫生的新治療份額大幅增加。
In absolute terms, Jardiance new-to-therapy volume has increased by 75% since we began active promotion of the new CV indication.
從絕對值來看,自從我們開始積極推廣新的 CV 適應症以來,Jardiance 的新療法數量增加了 75%。
We continue to see rapid uptake of Taltz as well as continued strong growth of the IL-17A class in psoriasis.
我們繼續看到 Taltz 的快速吸收以及 IL-17A 類在銀屑病中的持續強勁增長。
We're excited that our new-to-brand share of market with dermatologists, a proxy for use in psoriasis, exceeds that of Enbrel and COSENTYX.
我們很高興我們與皮膚科醫生的新品牌市場份額(用於銀屑病的代理)超過了 Enbrel 和 COSENTYX。
On Basaglar, we launched here in the U.S. in mid-December and are seeing strong uptake early this year largely driven by switching in high controlled PBM formularies.
在 Basaglar 上,我們於 12 月中旬在美國推出,並在今年年初看到強勁的吸收,這主要是由於轉換了高度受控的 PBM 配方。
U.S. new-to-brand share of market is approaching Levemir and exceeds that of both Tresiba and Toujeo.
美國新品牌的市場份額正在接近 Levemir,並超過 Tresiba 和 Toujeo。
In Q4, we also launched Lartruvo for soft tissue sarcoma in the U.S. and in early launch markets in Europe, and this quarter, have begun to launch in select rest of world countries.
在第四季度,我們還在美國和歐洲的早期推出市場推出了用於軟組織肉瘤的 Lartruvo,本季度,已開始在世界其他部分國家推出。
We're excited by initial physician feedback and the potential of this molecule to help patients with soft tissue sarcoma.
我們對最初的醫生反饋和這種分子幫助軟組織肉瘤患者的潛力感到興奮。
Finally, earlier this quarter, we launched Olumiant in Europe, with this quarter's sales representing initial stocking in Germany.
最後,本季度早些時候,我們在歐洲推出了 Olumiant,本季度的銷售額代表了德國的初始庫存。
We are pleased with the initial customer feedback, and we see great potential for this molecule in Europe.
我們對最初的客戶反饋感到滿意,我們看到了這種分子在歐洲的巨大潛力。
Moving to Slide 14, you'll see that changes in foreign exchange rates had a modest effect on our Q1 2017 results.
轉到幻燈片 14,您會看到外匯匯率的變化對我們 2017 年第一季度的業績產生了適度的影響。
Growth in non-GAAP EPS was 18% including the effect of FX and 22% in constant-currency terms.
包括外匯影響在內的非公認會計原則每股收益增長 18%,按固定匯率計算增長 22%。
Moving on to our pipeline update.
繼續我們的管道更新。
Slide 15 shows our NME pipeline as of April 18.
幻燈片 15 顯示了截至 4 月 18 日我們的 NME 管道。
We had positive movement which included the European approval of Olumiant, the addition of lasmitidan for acute migraine treatment via our acquisition of CoLucid, initiation of human testing for a long-acting insulin and termination of development of a Phase I diabetes asset.
我們取得了積極的進展,其中包括 Oluminant 在歐洲的批准,通過收購 CoLucid 增加了用於急性偏頭痛治療的 lasmitidan,開始對長效胰島素進行人體測試以及終止 I 期糖尿病資產的開發。
In our NILEX pipeline, on Slide 16, you'll see the initiation in collaboration with Boehringer Ingelheim of the Phase III heart failure program for empagliflozin as well as the initiation of Phase II work with abemaciclib in pancreatic cancer.
在我們的 NILEX 管道中,在幻燈片 16 上,您將看到與 Boehringer Ingelheim 合作啟動 empagliflozin 的 III 期心力衰竭項目,以及啟動 abemaciclib 治療胰腺癌的 II 期工作。
Now turning to Slide 17.
現在轉到幻燈片 17。
Let's recap the recent progress we've made on the key events we projected for 2017.
讓我們回顧一下我們在 2017 年預測的關鍵事件上取得的最新進展。
Since our last call, we've added checkmarks for the initiation of the improved studies of empagliflozin for heart failure in collaboration with Boehringer Ingelheim, the positive PFS readout for the ramucirumab RAINFALL trial, the U.S. submission of ixekizumab for psoriatic arthritis, the EU approval of baricitinib for rheumatoid arthritis, the closing of the CoLucid acquisition and the favorable Japanese Supreme Court ruling upholding our Alimta IP.
自上次電話會議以來,我們已添加複選標記,以啟動與勃林格殷格翰合作的 empagliflozin 治療心力衰竭的改進研究、ramucirumab RAINFALL 試驗的陽性 PFS 讀數、美國提交的 ixekizumab 治療銀屑病關節炎、歐盟批准baricitinib 治療類風濕性關節炎、完成 CoLucid 收購以及日本最高法院支持我們 Alimta IP 的有利裁決。
We've also added a red checkmark for the FDA's Complete Response Letter for baricitinib.
我們還為 FDA 對巴瑞替尼的完整回复信添加了一個紅色複選標記。
You will also see that we've moved the MONARCH 3 data readout from the internal readouts to the external disclosures section based on the positive interim analysis that will allow us to present the data at a medical meeting in the second half of the year.
您還將看到,基於積極的中期分析,我們已將 MONARCH 3 數據讀數從內部讀數移至外部披露部分,這將使我們能夠在下半年的醫療會議上展示數據。
We've also added potential key events for the global regulatory submissions of the abemaciclib MONARCH 3 data, the readout and likely presentation at a medical meeting later this year for the second Phase III trial of lasmiditan and for the potential FDA action on the sBLA for ixekizumab for psoriatic arthritis.
我們還為 abemaciclib MONARCH 3 數據的全球監管提交、今年晚些時候 lasmiditan 的第二次 III 期試驗的醫學會議上的讀數和可能的演示以及 FDA 對 sBLA 的潛在行動添加了潛在的關鍵事件ixekizumab 用於銀屑病關節炎。
Turning to our 2017 financial guidance on Slide 18.
轉向我們關於幻燈片 18 的 2017 年財務指導。
Our expectations for 2017 are largely unchanged from our last update in late January.
我們對 2017 年的預期與 1 月底的上次更新相比基本沒有變化。
You'll see that our non-GAAP line item guidance remains the same.
您會看到我們的非 GAAP 訂單項指南保持不變。
However, we have adjusted our GAAP EPS guidance, primarily due to the global severance charges related to actions to improve our cost structure.
但是,我們調整了我們的 GAAP EPS 指導,主要是由於與改善我們的成本結構的行動相關的全球遣散費。
Before we go to the Q&A session, let me briefly sum up.
在進入問答環節之前,讓我簡單總結一下。
2017 is off to a strong start.
2017 年開局良好。
Led by our new products, worldwide revenue grew 7%.
在我們的新產品的帶動下,全球收入增長了 7%。
By driving improvements in our cost structure, we leveraged that top line growth into 18% non-GAAP EPS growth, or 22% growth when excluding FX.
通過推動成本結構的改進,我們將收入增長轉化為 18% 的非公認會計原則每股收益增長,或在不包括外彙的情況下增長 22%。
While we're disappointed with the delay of baricitinib here in the U.S., we continue to have strong momentum behind our innovation-based strategy.
雖然我們對巴瑞克替尼在美國的延遲感到失望,但我們在以創新為基礎的戰略背後繼續保持強勁勢頭。
Since our last earnings call, we've launched Olumiant in Europe and had positive Phase III readouts for abemaciclib, Taltz and Cyramza.
自上次財報電話會議以來,我們在歐洲推出了 Olumiant,並獲得了 abemaciclib、Taltz 和 Cyramza 的第三階段積極讀數。
We also closed the CoLucid acquisition, bolstering our Phase III pipeline with the addition of lasmiditan.
我們還完成了對 CoLucid 的收購,通過添加 lasmiditan 來支持我們的第三階段管道。
Going forward, our management team will remain focused on launching new products with excellence, reloading our late-stage pipeline, driving increased productivity to expand our operating margins and investing in the core drivers of our business: talent, scientific capabilities and technology platforms to ensure our future growth prospects.
展望未來,我們的管理團隊將繼續專注於推出卓越的新產品,重新加載我們的後期管道,提高生產力以擴大我們的營業利潤,並投資於我們業務的核心驅動力:人才、科學能力和技術平台,以確保我們未來的增長前景。
Now this concludes our prepared remarks.
現在到此結束我們準備好的評論。
I'll turn the call over to Phil to moderate the Q&A session.
我將把電話轉給 Phil 來主持問答環節。
Phil?
菲爾?
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Great.
偉大的。
Thanks, Derica.
謝謝,德麗卡。
We would like to take as many questions from callers as we can.
我們希望盡可能多地回答來電者的問題。
(Operator Instructions) And we thank you in advance for collaborating with this request.
(操作員說明)我們提前感謝您配合此請求。
John, if you could go ahead and provide the instructions for the Q&A session, and then we're ready for the first caller.
約翰,如果您可以繼續提供問答環節的說明,那麼我們就可以接聽第一個來電者了。
Operator
Operator
(Operator Instructions) And first go to Tim Anderson with Bernstein.
(操作員說明)首先和伯恩斯坦一起去找蒂姆·安德森。
Timothy Minton Anderson - Senior Analyst
Timothy Minton Anderson - Senior Analyst
My question is on abemaciclib and your latest thinking about the ability to show that your drug is more efficacious than palbo.
我的問題是關於 abemaciclib 和你關於證明你的藥物比 palbo 更有效的能力的最新想法。
Because your pivotal trials didn't have palbo as a comparator, any aspect of these comparisons can really only be made on a side-by-side basis, and naturally, that has certain limitations.
因為您的關鍵試驗沒有將 palbo 作為比較器,所以這些比較的任何方面實際上只能在並排的基礎上進行,當然,這有一定的局限性。
So it assumes that the difference with abema would have to be quite big to really be perceived as a better product, and is this something that you think is achievable?
所以它假設與 abema 的差異必須相當大才能真正被視為更好的產品,您認為這是可以實現的嗎?
I'd like to get your latest thinking on that.
我想听聽你對此的最新想法。
And then a payer question, if you can just talk about payer trends and rebating trends in the SGLT2 category, if you addressed that earlier, I was on another call, so I apologize.
然後是付款人問題,如果您能談談 SGLT2 類別中的付款人趨勢和回扣趨勢,如果您之前解決過這個問題,我正在另一個電話中,所以我道歉。
And on Cyramza, any additional color on -- you, I think you mentioned U.S. pricing erosion, which is unusual with a medical benefit drug in the U.S.
在 Cyramza 上,任何額外的顏色 - 你,我想你提到了美國的定價侵蝕,這在美國的醫療福利藥物中是不尋常的。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Okay.
好的。
Tim, thank you for the questions.
蒂姆,謝謝你的提問。
So Sue, if you'll handle maybe the first question that we had on abemaciclib, and then the third one on Cyramza.
所以 Sue,如果你能處理我們關於 abemaciclib 的第一個問題,然後是關於 Cyramza 的第三個問題。
Enrique, if you'd like to comment on the SGLT2 pricing.
Enrique,如果您想對 SGLT2 定價發表評論。
Susan Mahony - SVP and President of Lilly Oncology
Susan Mahony - SVP and President of Lilly Oncology
Hi, Tim.
嗨,蒂姆。
Yes, thanks for the question on abemaciclib.
是的,感謝關於 abemaciclib 的問題。
As you say, there are no comparative studies of the CDK 4 and 6 inhibitors.
正如你所說,沒有 CDK 4 和 6 抑製劑的比較研究。
We believe that it's going to be important that we look at the totality of the data across multiple trials as we look at these agents.
我們相信,當我們查看這些藥物時,查看多個試驗中的全部數據非常重要。
I think I've been consistently saying that we believe that we could have a best-in-class CDK 4 and 6 inhibitor, and I continue to believe that based on the attributes of the molecule as well as, as we say, look at the consistency of data across multiple trials and that hopefully, we will read out 2 of them this year, and we will have others coming in the future.
我想我一直在說,我們相信我們可以擁有一流的 CDK 4 和 6 抑製劑,而且我仍然相信,基於分子的屬性,以及正如我們所說,看看多個試驗數據的一致性,希望我們今年能讀出其中的兩個,未來還會有其他的。
Why do I say that?
我為什麼這麼說?
Well, as we've mentioned before, this molecule selectively inhibits CDK 4 versus CDK 6. It's actually 14x more potent on CDK 4 than CDK 6. It has the ability to cross the blood-brain barrier, and we have seen therapeutic levels on brain tissue.
好吧,正如我們之前提到的,這種分子選擇性地抑制 CDK 4 和 CDK 6。它對 CDK 4 的作用實際上是 CDK 6 的 14 倍。它具有穿過血腦屏障的能力,我們已經看到了治療水平腦組織。
The continuous dosing, we believe, is important for a cell-cycle inhibitor and not just from an efficacy perspective but also from a convenience perspective for patients.
我們認為,連續給藥對於細胞週期抑製劑很重要,不僅從療效的角度來看,而且從患者的便利性角度來看也是如此。
And we have seen in our previous trials, and have consistent results that the diarrhea, which is the main side effect, is manageable and, actually, is transient.
我們在之前的試驗中已經看到,並且一致的結果表明,作為主要副作用的腹瀉是可控的,實際上是短暫的。
So we now have a MONARCH 1 trial in refractory patients who have had multiple treatments and have seen in that trial single-agent activity with this agent.
因此,我們現在對接受過多種治療的難治性患者進行了一項 MONARCH 1 試驗,並在該試驗中看到了該藥物的單藥活性。
We now have 2 positive Phase III trials with the patients on our second-line MONARCH 2 trial, which had previous endocrine therapy, and we're looking forward to presenting that data at ASCO, and also hopefully, publishing that data this year too.
我們現在在我們的二線 MONARCH 2 試驗中對患者進行了 2 項積極的 III 期試驗,該試驗曾接受過內分泌治療,我們期待在 ASCO 上展示這些數據,並希望今年也能公佈這些數據。
And of course, yesterday, we announced the MONARCH 3, first-line study against the aromatase inhibitors, where we saw at the interim, and we mentioned previously, that we had a high bar interim.
當然,昨天,我們宣布了 MONARCH 3,針對芳香化酶抑製劑的一線研究,我們在此期間看到,我們之前提到過,我們有一個高標準的中期。
We saw that at interim, we achieved our PFS endpoint, which was the primary endpoint as well as a secondary endpoint of overall response rate.
我們看到,在過渡期間,我們實現了 PFS 終點,這是主要終點,也是總體反應率的次要終點。
And so we're excited as we look at the whole molecule here, and we encourage you to see the data in the future to look at the totality of the data across all the trials.
因此,當我們在這裡看到整個分子時,我們感到很興奮,我們鼓勵您在未來查看數據,以查看所有試驗中的全部數據。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
On the Cyramza piece.
在 Cyramza 上。
Susan Mahony - SVP and President of Lilly Oncology
Susan Mahony - SVP and President of Lilly Oncology
Oh, Cyramza.
哦,西拉姆扎。
With regards to Cyramza, yes.
關於 Cyramza,是的。
As we're looking at Cyramza performance in the U.S., Tim, we continue to see challenges in the lung cancer market, mainly due to IOs.
當我們關注 Cyramza 在美國的表現時,蒂姆,我們繼續看到肺癌市場的挑戰,主要是由於 IO。
And so we've essentially seen sort of flat to declining sales in the U.S. over the last few quarters, which of course, is the complete opposite to Japan, where we're seeing phenomenal sales.
因此,在過去的幾個季度中,我們基本上看到美國的銷售額持平或下降,當然,這與日本完全相反,我們看到了驚人的銷售額。
Our focus in the U.S., it's really a gross net adjustment that you mentioned there, so I wouldn't read too much into the pricing, our focus is to continue to ensure that we have uptake in gastric cancer, which is a very differentiated market.
我們的重點是美國,你在那裡提到的確實是一個總的淨調整,所以我不會過多地解讀定價,我們的重點是繼續確保我們在胃癌中的應用,這是一個非常差異化的市場.
A lot of doctors who treat gastric cancer in the U.S. treat 1 patient a year.
在美國,許多治療胃癌的醫生每年治療一名患者。
And so really getting to them on time to ensure that they know to use Cyramza in the appropriate patient is our focus in gastric cancer.
因此,真正按時聯繫他們以確保他們知道在適當的患者中使用 Cyramza 是我們在胃癌方面的重點。
And in lung cancer, as people are getting used to knowing where to use the IOs in second line, and then if they move to front line, we've been clear on the patient that we believe can benefit from Cyramza.
在肺癌中,隨著人們習慣於知道在二線使用 IO 的位置,然後如果他們轉移到前線,我們已經很清楚我們相信可以從 Cyramza 中受益的患者。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Great.
偉大的。
Just to complement Sue's answer, on that gross to net adjustment, it was essentially a benefit that was recognized.
只是為了補充 Sue 的回答,就總淨調整而言,它本質上是一種公認的好處。
We trued up the estimates for rebates and discounts in Q1 of 2016, and it's leading to the negative year-on-year compare.
我們在 2016 年第一季度修正了對回扣和折扣的估計,這導致了負的同比比較。
So nothing unusual that we're seeing in the actual contracting or pricing for the product.
因此,我們在產品的實際合同或定價中沒有看到任何異常情況。
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
Thank you.
謝謝你。
So the SGLT2 class is, similarly to other diabetes classes, is highly managed from a formulary perspective.
因此,SGLT2 類別與其他糖尿病類別類似,從處方的角度來看是高度管理的。
I -- we are in a unique position, given the data and the label that we basically have with Jardiance.
我——考慮到我們在 Jardiance 中基本上擁有的數據和標籤,我們處於一個獨特的位置。
And as I have previously shared, even prior to us getting the label, our formulary positioning was very strong.
正如我之前分享的那樣,甚至在我們獲得標籤之前,我們的處方定位就非常強大。
So just to give a sense, we have nearly 90% access on commercial plans and about 70% in Part D, and we feel that's a very strong position for us.
因此,只是為了說明一下,我們在商業計劃中擁有近 90% 的訪問權限,在 D 部分中擁有約 70% 的訪問權限,我們認為這對我們來說是一個非常強大的位置。
The SGLT2 class, for the most part, is being contracted as one of 2 type of contracts, so these are not sole exclusive contracts.
SGLT2 類在很大程度上是作為兩種合同之一簽訂的,因此這些不是唯一的排他性合同。
We, of course, we are advocates for open access, and we are, at this point in time, we are excited about the early trends that we're seeing for our products.
當然,我們是開放獲取的倡導者,在這個時候,我們對我們看到的產品的早期趨勢感到興奮。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Great.
偉大的。
Thank you, Enrique.
謝謝你,恩里克。
John, if we can go to the next caller, please?
約翰,如果我們可以去找下一位來電者,好嗎?
Operator
Operator
And that will be Seamus Fernandez with Leerink.
那將是 Seamus Fernandez 和 Leerink。
Seamus Christopher Fernandez - MD, Major Pharmaceuticals and Biotechnology
Seamus Christopher Fernandez - MD, Major Pharmaceuticals and Biotechnology
Just a couple of quick ones.
只是幾個快速的。
First, on abemaciclib, can you guys talk a little bit about what you think is a differentiated response rate in the setting for, whether it be for MONARCH 3. Again, my understanding is that we're seeing in combination with the aromatase inhibitors response rates between 52% and 55%.
首先,關於 abemaciclib,你們能否談談您認為在 MONARCH 3 的設置中的差異化響應率。再次,我的理解是我們看到與芳香酶抑製劑響應相結合利率在 52% 和 55% 之間。
So it seems like the response rate dynamic is something that you're focusing in on.
因此,響應率動態似乎是您關注的重點。
Love to just better understand what you see as a uniquely meaningful response rate or if you're really just focused on the monotherapy response rate that you see with abemaciclib and we already knew.
喜歡更好地了解您所看到的獨特有意義的反應率,或者您是否真的只關注您在 abemaciclib 上看到的單一療法反應率,我們已經知道了。
The second question, when I look at the revenue that was generated relative to the scripts for Basaglar, it certainly came in a bit below our expectations.
第二個問題,當我查看相對於 Basaglar 腳本產生的收入時,它肯定低於我們的預期。
Just trying to get a better sense of what the dynamics are in that market in particular that would have the revenue come in below those expectations, and that's also factoring in the stocking that occurred in the fourth quarter, so I don't see that as a full explanation.
只是想更好地了解該市場的動態,尤其是收入低於預期的情況,這也考慮到第四季度發生的庫存,所以我不認為這是一個完整的解釋。
And then lastly, in terms of the dynamics with baricitinib, some of the questions that we get from investors are the reasons why Lilly chose to incorporate the language in the press release with regard to its disagreement with the agency.
最後,就巴瑞替尼的動態而言,我們從投資者那裡得到的一些問題是禮來(Lilly)選擇在新聞稿中加入有關其與該機構分歧的語言的原因。
That seems to imply that Lilly will pursue all avenues before being forced to do additional clinical studies.
這似乎意味著禮來將在被迫進行額外的臨床研究之前尋求所有途徑。
So just trying to get a better sense of why you chose to incorporate that language into the press release.
因此,只是想更好地了解您選擇將該語言納入新聞稿的原因。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Okay, Seamus.
好的,西莫。
Thanks for the questions.
感謝您的提問。
So Sue, we'll start with you for abemaciclib and the question on overall response rate.
所以 Sue,我們將從 abemaciclib 和關於總體響應率的問題開始。
Enrique, for Basaglar, our revenue here in the U.S. relative to scripts.
Enrique,對於 Basaglar,我們在美國的相對於腳本的收入。
And then Chris to your first question on baricitinib and the language we had in the press release.
然後克里斯回答你關於巴瑞克替尼的第一個問題,以及我們在新聞稿中使用的語言。
Sue?
起訴?
Susan Mahony - SVP and President of Lilly Oncology
Susan Mahony - SVP and President of Lilly Oncology
Yes.
是的。
Thanks, Seamus for the question.
謝謝,Seamus 的問題。
I think, again, I'll go back to I think it's going to be really important that we look at the totality of the data as we look at the trials, across multiple trials, with the CDK 4 and 6 inhibitors and we look at the magnitude and the depth of response, which is a key secondary endpoint that we had in our studies as well as, as we said, the PFS and the totality of the data.
我想,再一次,我會回過頭來,我認為當我們查看使用 CDK 4 和 6 抑製劑的多個試驗的試驗時查看數據的整體性非常重要,我們查看響應的幅度和深度,這是我們研究中的一個關鍵次要終點,正如我們所說,PFS 和數據的整體性。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
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 Seamus, as I look at it, stocking does, in our view, basically explain the different revenue for us, and given the script level, is basically tracking as we had expected.
所以Seamus,在我看來,在我們看來,庫存確實為我們解釋了不同的收入,並且考慮到劇本水平,基本上是按照我們的預期進行跟踪的。
I think it's important as we look at this product, we are clearly right now north of 20% when it comes to NBRx share.
我認為當我們看這個產品時這很重要,當談到 NBRx 份額時,我們現在顯然已經超過了 20%。
Importantly, a big part of that is driven by switches, as we've seen different payers take, or choose Basaglar as an exclusive option.
重要的是,其中很大一部分是由開關驅動的,因為我們已經看到不同的付款人採取或選擇 Basaglar 作為獨家選項。
But I think why we're also encouraged is when we look at basically new patients to a basal insulin, we also see our share basically improving.
但我認為我們也受到鼓勵的原因是,當我們看到基本上新患者使用基礎胰島素時,我們也看到我們的份額基本上有所提高。
We're now at 7% on that specific metric.
我們現在在該特定指標上為 7%。
So we are very encouraged for what we see.
因此,我們對我們所看到的感到非常鼓舞。
And at this point in time, we do think that the revenue and the scripts are aligned based on what we had expected.
在這個時間點,我們確實認為收入和劇本是根據我們的預期進行調整的。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
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
Hi.
你好。
Yes, thanks for the question.
是的,謝謝你的提問。
I think what you read is exactly right regarding bari.
我認為你讀到的關於巴里的內容是完全正確的。
We continue to believe in the risk-benefit profile of baricitinib at the 4 and 2 milligram -- and what we need to do next is really get with the FDA and understand specifically what their concerns are.
我們繼續相信 4 和 2 毫克 baricitinib 的風險-收益概況——我們接下來需要做的是真正與 FDA 取得聯繫,並具體了解他們的擔憂是什麼。
So the answer is, yes, we disagree, but we want to meet with them, and make sure that we understand completely and see if we can find a path forward quickly to allow patients that are suffering access to baricitinib.
所以答案是,是的,我們不同意,但我們想與他們會面,並確保我們完全理解並看看我們是否能迅速找到前進的道路,讓正在遭受巴瑞替尼治療的患者獲得治療。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Great.
偉大的。
Thanks, Christi.
謝謝,克里斯蒂。
And before we go to the next caller, Seamus, I believe the numbers that you're citing for overall response rate are in fact for those patients with measurable disease.
在我們聯繫下一位呼叫者 Seamus 之前,我相信您引用的總體響應率數字實際上是針對那些患有可測量疾病的患者。
Just to highlight that when you see data from our trials, make sure that you're looking at a similar patient population and cut of the data.
只是強調一下,當您看到我們試驗的數據時,請確保您正在查看相似的患者群體並截取數據。
John, if we can go to the next caller, please.
約翰,如果我們可以去找下一位來電者,請。
Operator
Operator
That will be Gregg Gilbert with Deutsche Bank.
那將是德意志銀行的格雷格吉爾伯特。
Gregory B. Gilbert - MD and Senior Analyst
Gregory B. Gilbert - MD and Senior Analyst
One two-parter here.
這裡是一個二人組。
First, when you announced the bari delay, you reiterated your 5% revenue growth goal.
首先,當您宣布巴里延遲時,您重申了 5% 的收入增長目標。
My question is since it will be harder to get there without bari, and assuming that doesn't show up in that time frame, what are the caveats that you would offer in terms of reaching that goal without bari other than the Alimta caveat you've mentioned before.
我的問題是,因為如果沒有 bari 就更難到達那裡,並且假設在那個時間範圍內沒有出現,那麼除了 Alimta 警告你之外,在沒有 bari 的情況下,你會提供哪些警告來實現這個目標之前提到過。
So hoping for a little more granularity underpinning your confidence in achieving that.
因此,希望有更多的粒度來支持您實現這一目標的信心。
And secondly, on animal health, can you go a little bit deeper into the trends in the quarter, perhaps, with and without acquisition?
其次,關於動物健康,您能否更深入地了解本季度的趨勢,無論是否有收購?
And Jeff, any sort of headwinds, tailwinds, you'd want us to understand in the quarter and as it relates for the rest of the year for your business?
傑夫,任何形式的逆風,順風,您希望我們在本季度了解以及與您的業務相關的今年剩餘時間?
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Great.
偉大的。
Gregg, thank you for the questions.
格雷格,謝謝你的提問。
Derica, we'll start out with you for the long-term growth question.
Derica,我們將從您的長期增長問題開始。
And then over to you, Jeff, for the animal health question.
然後交給你,傑夫,關於動物健康問題。
Derica.
德里卡。
Derica W. Rice - CFO and EVP of Global Services
Derica W. Rice - CFO and EVP of Global Services
Good morning, Gregg, and thanks for your question.
早上好,格雷格,感謝您的提問。
As it relates to the midterm guidance of achieving a minimum of 5% on average revenue growth between '16 and the end of the decade, there are no new additional caveats that I can offer, Gregg.
由於它與在 16 年到本世紀末之間實現平均收入增長至少 5% 的中期指導有關,因此我無法提供新的額外警告,格雷格。
We feel as confident about achieving that goal today as we did when we put that guidance out last year in July.
我們對今天實現這一目標充滿信心,就像我們去年 7 月發布該指南時所做的那樣。
Recall that we've always said that the growth prospects for Lilly did not reside or rest on a single asset.
回想一下,我們一直說禮來的增長前景並不依賴於或依賴於單一資產。
It really is about the strength across the portfolio of opportunities that we've talked about.
這確實是關於我們討論過的機會組合的優勢。
And up to now, we've launched 7 new products, and 8 if you include Olumiant in Europe.
到目前為止,我們已經推出了 7 款新產品,如果包括 Olumiant,我們在歐洲推出了 8 款。
So we feel very good about our growth prospects going forward, and we've factored in that we may not always have 100% success across each molecule, but in aggregate, we're very confident we can achieve that minimum 5% goal.
因此,我們對未來的增長前景感覺非常好,並且我們考慮到我們可能並不總是在每個分子上都取得 100% 的成功,但總的來說,我們非常有信心能夠實現至少 5% 的目標。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Great.
偉大的。
Thanks, Derica.
謝謝,德麗卡。
Jeff?
傑夫?
Jeffrey N. Simmons - SVP and President of Elanco Animal Health
Jeffrey N. Simmons - SVP and President of Elanco Animal Health
Yes.
是的。
Gregg, on animal health, a few comments.
Gregg,關於動物健康,發表了一些評論。
First of all, as we signaled earlier this year, and as Q1 indicates, we anticipate growth for the year will be back half loaded.
首先,正如我們今年早些時候所暗示的那樣,正如第一季度所表明的那樣,我們預計今年的增長將恢復到一半。
This is due to some onetime events in Q1 as well as our SAP 2016 implementation, which will impact Q2.
這是由於第一季度的一些一次性事件以及我們的 SAP 2016 實施,這將影響第二季度。
As such though, although Q1 was a little lighter than expected, we anticipate improving growth trends later this year.
儘管如此,儘管第一季度比預期的要輕一些,但我們預計今年晚些時候增長趨勢會有所改善。
What will drive that, Gregg, is really a few things.
格雷格,真正的驅動因素是幾件事。
First of all, launches.
首先,啟動。
We're seeing good uptake initially here with Galliprant, our deal with Aratana, as well as we've got some launches in aquaculture.
我們看到最初與 Galliprant、我們與 Aratana 的交易以及我們在水產養殖領域推出的一些產品取得了良好的效果。
Secondly, is companion animals, some share shift, and then on the food animal side, vaccines.
其次是伴侶動物,有的分享轉移,然後是食用動物方面,疫苗。
So that will be the drivers of our second half return to growth.
因此,這將是我們下半年恢復增長的驅動力。
We continue to be excited about the BI acquisition, and that's progressing well.
我們繼續對 BI 的收購感到興奮,而且進展順利。
I also would say, finally, we continue to progress our strategic agenda, focusing on our key growth engines, which we've talked a lot about: vaccines, nutritionals and companion animal therapeutics.
最後,我還要說的是,我們將繼續推進我們的戰略議程,重點關注我們已經討論過很多的關鍵增長引擎:疫苗、營養品和伴侶動物療法。
The integration of BI, again, is going well, and that's on track, and we've completed the sale of our Dundee, Scotland, manufacturing site to Argenta as part of our broader manufacturing agenda.
再次,BI 的整合進展順利,而且正在步入正軌,作為我們更廣泛的製造議程的一部分,我們已經完成了將蘇格蘭鄧迪製造基地出售給 Argenta 的工作。
So overall industry, I think the things to watch, I think the fundamentals for the medium- and long-term are still strong with the trends with durable brands.
所以整個行業,我認為值得關注的事情,我認為中長期的基本面仍然強勁,具有耐用品牌的趨勢。
I think the things to watch, innovation is representing an increasing amount of growth and becoming increasingly important.
我認為值得關注的是,創新代表著越來越多的增長,並且變得越來越重要。
We're not seeing, for instance, in food animal as much innovation, so that segment has not grown as much.
例如,我們沒有在食用動物中看到如此多的創新,因此該細分市場並沒有增長那麼多。
And I think in the slower growth segments, we're seeing, of course, increasing competitive pressures.
我認為,在增長較慢的領域,我們當然會看到競爭壓力越來越大。
So those are some things, I think, to watch going forward.
因此,我認為這些都是值得關注的事情。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Great.
偉大的。
Thanks, Jeff.
謝謝,傑夫。
Can we go to the next caller, please?
我們可以去找下一個來電者嗎?
Operator
Operator
And we'll go to Andrew Baum with Citi.
我們將和花旗一起去安德魯鮑姆。
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。
You obviously showed some very significant improvement in your gross margin during the quarter, that's factoring manufacturing efficiencies.
您顯然在本季度的毛利率方面表現出非常顯著的改善,這是考慮到製造效率的因素。
Could you just separate out mix versus manufacturing?
你能把混合和製造分開嗎?
And then, within manufacturing, procurement, yield, and so on to help us understand how far those 2 go here?
然後,在製造、採購、產量等方面,以幫助我們了解這兩個方面能走多遠?
And then second, on Jardiance, could you just outline the rate limiting stats for this product, both in terms of class awareness and, obviously, the pending canvas data to grow the awareness of the class.
其次,在 Jardiance 上,您能否概述一下該產品的速率限制統計數據,無論是在課堂意識方面,還是在待定的畫布數據方面,以提高課堂意識。
And then secondly, in terms of education of physicians, the potential advantages, what can be done by you in order to break down barriers to accelerate uptake?
其次,在醫生的教育方面,潛在的優勢,您可以做些什麼來打破障礙以加速吸收?
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Andrew, thank you for the questions.
安德魯,謝謝你的問題。
Derica, we'll go to you for the question on the gross margin percent.
Derica,我們將向您詢問有關毛利率百分比的問題。
And then Enrique for the Jardiance questions.
然後是 Enrique 的 Jardiance 問題。
Derica?
德麗卡?
Derica W. Rice - CFO and EVP of Global Services
Derica W. Rice - CFO and EVP of Global Services
Hi, Andrew.
嗨,安德魯。
In this question, I really have to give kudos to our manufacturing team.
在這個問題上,我真的要給我們的製造團隊點贊。
The gross margin improvement is really driven by lowering our per-unit costs.
毛利率的提高實際上是通過降低我們的單位成本來推動的。
It's not due to mix effect, and that means that it should be sustainable going forward.
這不是由於混合效應,這意味著它應該是可持續的。
Do recall also that in the second half of the year, you're going to see negative pressure on our gross margins because we began to feel the impact of the next round of patent expiries.
請記住,在下半年,您將看到我們的毛利率受到負面壓力,因為我們開始感受到下一輪專利到期的影響。
So we will have lost Strattera and Effient in the U.S. So that's what brings down the drag that we expect in the second half.
因此,我們將在美國失去 Strattera 和 Effient。這就是我們預期下半年拖累的原因。
But again, what's helping us to weather that is by the manufacturing team absolutely reducing our per-unit costs.
但同樣,幫助我們度過難關的是製造團隊絕對降低了我們的單位成本。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Thank you, Derica.
謝謝你,德麗卡。
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。
Let me first provide a little bit of color on Jardiance and what we're seeing since the launch of our cardiovascular indication.
讓我首先提供一點關於 Jardiance 的色彩以及自推出心血管適應症以來我們所看到的情況。
As you know, we received that indication in December, and we launched in mid-January.
如您所知,我們在 12 月收到了該指示,並於 1 月中旬推出。
Since we've launched that indication, we have seen a significant inflection on new patient starts for Jardiance.
自從我們推出該適應症以來,我們已經看到 Jardiance 的新患者開始出現顯著變化。
So just in 3 months, we've seen a 70%, 7 0 percent increase on new patient starts.
因此,僅在 3 個月內,我們就看到了 70% 到 7 0% 的新患者開始增長。
That class overall has grown about 30%, which has driven now the class to basically reaccelerate when it comes to new patient starts.
該課程總體增長了約 30%,這促使該課程在新患者開始時基本上重新加速。
The class was actually quite flat before this indication.
在這個指示之前,班級實際上是相當平坦的。
As we look at the 4 weeks -- the 4-week growth versus the previous year, we're now at 16%.
當我們查看 4 週時 - 與上一年相比的 4 週增長,我們現在為 16%。
So we are encouraged in terms of what we're seeing with Jardiance.
因此,我們對 Jardiance 所看到的內容感到鼓舞。
Now clearly, we are, in a certain way, it is a paradigm shift when it comes to treating diabetes, in particular, the risk of death for people with type 2 diabetes and established cardiovascular disease.
現在很明顯,在某種程度上,我們在治療糖尿病方面是一種範式轉變,特別是對於患有 2 型糖尿病和已確診心血管疾病的人的死亡風險。
And for us, therefore, peer-to-peer is hugely important and that's something that we've been quite focused on.
因此,對我們來說,點對點非常重要,這是我們一直非常關注的事情。
We are very excited by our level of activity and interest and attendance to these peer-to-peer sessions.
我們對這些點對點會議的活動水平、興趣和出席率感到非常興奮。
But all in all, we are pleased with our progress, and we expect more.
但總而言之,我們對我們的進步感到滿意,我們期待更多。
There are lots of questions when it comes to the outcomes from CANVAS.
關於 CANVAS 的結果有很多問題。
We basically see, maybe, generally, 3 types of outcomes, so let me just outline them.
我們基本上看到,也許,一般來說,三種類型的結果,所以讓我簡單地概述一下。
But clearly, if outcomes were to be a negative, a neutral trial when it comes to CV, that probably would be the worst outcome for us.
但很明顯,如果結果是消極的、中立的 CV 試驗,那對我們來說可能是最糟糕的結果。
We clearly believe in our data, it's highly compelling, but clearly, we could benefit from that tailwind of having another SGLT2 basically, have this similar data.
我們顯然相信我們的數據,它非常引人注目,但很明顯,我們可以從基本上擁有另一個 SGLT2 的順風中受益,擁有類似的數據。
If their data looks -- is positive but is not as positive as ours, that's probably the best case scenario for us.
如果他們的數據看起來是積極的,但不如我們的那麼積極,那對我們來說可能是最好的情況。
But it's also quite positive if their data looks similar to us.
但是,如果他們的數據看起來與我們相似,那也是相當積極的。
We clearly have a lot of momentum with our product, so we are hoping that they have a positive trial and are waiting to see what the results are.
我們的產品顯然有很大的動力,所以我們希望他們有一個積極的試驗,並正在等待看看結果是什麼。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Great.
偉大的。
Thank you, Enrique.
謝謝你,恩里克。
John, if we can go to the next caller, please.
約翰,如果我們可以去找下一位來電者,請。
Operator
Operator
And we'll go to John Boris, SunTrust.
我們將去找 SunTrust 的 John Boris。
John Thomas Boris - MD
John Thomas Boris - MD
In light of the successful launch of Basaglar across your diabetes franchise, strategically, is this a consideration to partner with other companies for biosimilars across possibly oncology or possibly across your immunology franchise with a product like Humira?
鑑於 Basaglar 在您的糖尿病專營權中的成功推出,從戰略上講,這是考慮與其他公司合作,在可能的腫瘤學或可能在您的免疫學專營權中使用 Humira 等產品的生物仿製藥?
Second question on productivity gains.
關於生產力提高的第二個問題。
For Derica, what have you learned about YZ that makes you confident as you prepare for another loss of exclusivity in '18 for Cialis that you're prepared to navigate through that, and any qualitative commentary you can give on the consensus earnings growth of 7% in '18.
對於 Derica,您對 YZ 的了解讓您有信心,因為您準備在 18 年為 Cialis 再次失去排他性,您已準備好度過難關,您可以對 7 的共識收益增長做出任何定性評論18 年的百分比。
I know you haven't given guidance there but certainly, a topical question.
我知道你沒有在那裡提供指導,但肯定是一個熱門問題。
And then lastly, on Jardiance.
最後,關於 Jardiance。
Certainly, the product had some pretty significant renal benefits.
當然,該產品具有一些非常顯著的腎臟益處。
Are you doing anything with the agency to further quantify the benefits, for the agency, to possibly go back to them to try and secure that within the label of Jardiance?
您是否與該機構做任何事情以進一步量化該機構的收益,以便該機構可能回到他們那裡嘗試並在 Jardiance 的標籤內確保這一點?
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Great, John.
太好了,約翰。
Thank you for the questions.
謝謝你的提問。
We'll go to Dave for the question on our interest in moving more into biosimilars, Derica for the productivity question and what we learned in YZ that can help for next year with '18, and then Enrique for the Jardiance in renal.
我們將向 Dave 詢問關於我們是否有興趣更多地進入生物仿製藥的問題,Derica 詢問生產力問題以及我們在 YZ 中學到的可以幫助明年 '18 的知識,然後詢問 Enrique 詢問腎臟領域的 Jardiance。
Dave?
戴夫?
David A. Ricks - CEO, President and Director
David A. Ricks - CEO, President and Director
Thanks.
謝謝。
Thanks, John.
謝謝,約翰。
Well, I think we've addressed this question before but just to reiterate, Basaglar is a great fit for us because we already have an asset base to make the product, we have a commercial investment that can sell the product, and we have devices that are world class that the product goes in.
好吧,我認為我們之前已經解決過這個問題,但只是重申一下,Basaglar 非常適合我們,因為我們已經擁有生產產品的資產基礎,我們有可以銷售產品的商業投資,而且我們有設備產品進入的世界一流水平。
So it's really a drop-in to a broader insulin play and it rounds out an important part of the portfolio we weren't participating in, which is the innovative basal segment, which is obviously a big segment of the diabetes market.
因此,它實際上是更廣泛的胰島素遊戲的一個替代品,它完善了我們未參與的投資組合的重要組成部分,即創新的基礎部分,這顯然是糖尿病市場的一個重要部分。
But our core strategy in diabetes is to innovate above and beyond the benefits of glargine in basal insulin as it is in all other therapies.
但我們在糖尿病領域的核心戰略是在甘精胰島素在基礎胰島素中的益處之外進行創新,就像在所有其他療法中一樣。
And that's really the same as our other therapy areas: oncology, immunology.
這和我們的其他治療領域是一樣的:腫瘤學、免疫學。
Our main focus is on innovation to beat the standard of care today for something better for patients.
我們的主要重點是創新,以超越當今的護理標準,為患者提供更好的服務。
If those same dynamics played out for a TNF biosimilar or something else, sure, we'd look at it.
如果同樣的動態也適用於 TNF 生物仿製藥或其他東西,當然,我們會看看它。
When you can get a lot of leverage financially and it tucks into your portfolio, that can make good sense.
當您可以在財務上獲得大量槓桿並將其納入您的投資組合時,這很有意義。
But we don't have a broad-based division associated with biosimilars.
但我們沒有與生物仿製藥相關的基礎廣泛的部門。
We're not pursuing that at this moment.
我們目前不追求這一點。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Great.
偉大的。
Thanks, Dave.
謝謝,戴夫。
Derica?
德麗卡?
Derica W. Rice - CFO and EVP of Global Services
Derica W. Rice - CFO and EVP of Global Services
Hi, John.
你好,約翰。
In regards to learnings from our YZ experience, the biggest difference is the fact that with this next wave of patent expiries, we are able to offset that with new product launches.
關於我們從 YZ 經驗中吸取的教訓,最大的不同是,隨著下一波專利到期,我們能夠通過推出新產品來抵消這一點。
When we launched our 4 largest products during that YZ period, we did not have any new product launches during that period.
當我們在那個 YZ 期間推出我們最大的 4 種產品時,我們在此期間沒有推出任何新產品。
So the real key is having new product launches.
所以真正的關鍵是推出新產品。
And then that's really contingent on our ability to sustain the flow of R&D output.
然後這真的取決於我們維持研發產出流動的能力。
So you'll see, we're very committed to that, and that's why you saw us announce the CoLucid deal earlier this quarter, which is, again, another increased effort in bolstering our late-phase pipeline.
所以你會看到,我們非常致力於這一點,這就是為什麼你看到我們在本季度早些時候宣布了 CoLucid 交易,這再次是加強我們後期管道的另一項努力。
And then the third learning is just having a sustained productivity agenda.
然後第三個學習只是有一個持續的生產力議程。
That's why we came out in 2015 in saying, hey, we believe we -- or excuse me, actually in 2012, we believe we can get to that 50% watermark in 2018 in terms of OpEx as a percent of revenue.
這就是為什麼我們在 2015 年出來說,嘿,我們相信我們 - 或者對不起,實際上在 2012 年,我們相信我們可以在 2018 年達到 50% 的水印,就運營支出佔收入的百分比而言。
We said that we can improve our gross margins between 2015 and 2020.
我們說我們可以在 2015 年到 2020 年之間提高我們的毛利率。
And while we set the 50% watermark for '18, we're not resting on our laurels thinking that's the end of the journey.
雖然我們為 18 年設定了 50% 的水印,但我們並沒有固步自封,認為這就是旅程的終點。
We think we can improve beyond that.
我們認為我們可以改進。
We just haven't put those statements out there at this point in time.
我們目前還沒有發布這些聲明。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Great.
偉大的。
Thanks, Derica.
謝謝,德麗卡。
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 clearly, the renal data for Jardiance has -- is quite encouraging.
很明顯,Jardiance 的腎臟數據非常令人鼓舞。
As we are -- had a number of discussions with the regulatory authorities, it is pretty clear that for us to be able to make a claim, it is quite likely that we will need to do an additional trial.
正如我們一樣 - 與監管機構進行了多次討論,很明顯,為了讓我們能夠提出索賠,我們很可能需要進行額外的試驗。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Thanks, Enrique.
謝謝,恩里克。
John, if we can go to the next caller, please.
約翰,如果我們可以去找下一位來電者,請。
Operator
Operator
And that'll be Jami Rubin with Goldman Sachs.
那將是高盛的 Jami Rubin。
Jamilu E. Rubin - Equity Analyst
Jamilu E. Rubin - Equity Analyst
Just a few questions.
只是幾個問題。
This is to Dave and Derica, is it safe to assume that in reiterating your medium-term guidance out to 2020 that you do ascribe some value to baricitinib?
這是給 Dave 和 Derica 的,是否可以安全地假設在重申到 2020 年的中期指導時,您確實認為巴瑞替尼具有一定的價值?
Or, Derica, you also just said that Lilly's not dependent on any one single product but a portfolio of products.
或者,Derica,您也剛剛說過禮來公司不依賴於任何單一產品,而是依賴於產品組合。
So if you could clarify that.
所以,如果你能澄清這一點。
Secondly, just curious to know your plans for baricitinib in the other indications such as AD, lupus, psoriatic arthritis.
其次,只是想知道您在其他適應症(如 AD、狼瘡、銀屑病關節炎)中的 baricitinib 計劃。
I know those are studies that are still early Phase II.
我知道這些研究仍處於 II 期早期。
Is the plan -- are those indications on hold until pending positive resolution on RA?
計劃是否——這些跡像是否會被擱置,直到等待 RA 的積極解決方案?
Or is it possible that you would go ahead with those plans?
還是有可能你會繼續這些計劃?
Is there a scenario where you decide not to go further with that RA if FDA is requiring large trials that would be expensive and might mean being at the -- no longer the first and best-in-class drug on the market?
如果 FDA 要求進行昂貴且可能意味著不再是市場上第一個和同類最佳藥物的大型試驗,您是否決定不再進一步使用該 RA?
And then just lastly, Dave, the problem is that unfortunately, that was a very expensive setback but that happens.
最後,戴夫,問題是不幸的是,這是一個非常昂貴的挫折,但這種情況發生了。
Now we have the baricitinib setback.
現在我們遇到了巴瑞替尼的挫折。
At what point do you think -- at what point can you justify to yourself a much more substantial restructuring initiative that really focuses on the company's cost structure?
你認為在什麼時候——你可以在什麼時候向自己證明一個真正關注公司成本結構的更實質性的重組計劃是合理的?
Yes, we acknowledge this quarter we did see good operating margin improvement, but going out and looking at where Lilly's margins are today relative to the industry average, you got a long way to go to reach parity.
是的,我們承認本季度我們確實看到了良好的營業利潤率改善,但走出去看看禮來公司今天的利潤率相對於行業平均水平,你要達到平價還有很長的路要走。
So just wondering if you could share your thoughts on that and at what point you actually start to get more aggressive on the margin side.
所以只是想知道你是否可以分享你的想法,以及在什麼時候你實際上開始在邊緣方面變得更具侵略性。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Great, Jami.
太好了,傑米。
Thanks for the questions.
感謝您的提問。
So we'll have Derica address the medium-term outlook as it relates to baricitinib and clarify our thoughts there.
因此,我們將讓 Derica 解決與巴瑞替尼相關的中期前景,並澄清我們的想法。
And then Christi, we'll have you talk about our other indications for baricitinib.
然後克里斯蒂,我們會讓你談談我們對巴瑞替尼的其他適應症。
And then Dave, the question regarding the longer-term outlook.
然後是戴夫,關於長期前景的問題。
Derica?
德麗卡?
Derica W. Rice - CFO and EVP of Global Services
Derica W. Rice - CFO and EVP of Global Services
Hi, Jami.
嗨,傑米。
In regard to our midterm guidance and the relevance of bari in the U.S., absolutely, we were planning for success of that molecule.
關於我們的中期指導和 bari 在美國的相關性,我們絕對是在計劃該分子的成功。
And we have not given up on the prospects of that opportunity.
我們並沒有放棄這個機會的前景。
So as Christi said earlier, we're looking forward to engaging with the FDA, and we'll work diligently to try to find a pathway forward to bring that molecule to patients here in the U.S. That being said, that guidance that we put out there around the 5%, that's what we believe to be the minimum performance that we thought we could achieve.
因此,正如克里斯蒂之前所說,我們期待與 FDA 合作,我們將努力尋找一條將這種分子帶給美國患者的途徑。話雖如此,我們發布的指導大約有 5%,這是我們認為我們認為可以實現的最低性能。
What we didn't do is provide what we thought was the maximum that we could achieve.
我們沒有做的是提供我們認為可以達到的最大值。
Even taking into account the impact of bari, we still believe we can stay above that 5% minimum goal that we established in terms of average growth between '15 and 2020.
即使考慮到巴里的影響,我們仍然相信我們可以保持在 15 年至 2020 年間平均增長 5% 的最低目標之上。
So again, our confidence is still very high in our ability to achieve that objective.
同樣,我們對實現這一目標的能力仍然非常有信心。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Thanks, Derica.
謝謝,德麗卡。
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 on the first multiphase, the first question I'll take is the one on rheumatoid arthritis.
所以在第一個多階段,我要回答的第一個問題是關於類風濕性關節炎的問題。
We have not contemplated a scenario in which we will not pursue baricitinib for rheumatoid arthritis.
我們還沒有考慮過不使用巴瑞替尼治療類風濕性關節炎的情況。
We continue to believe, as I said in the safety benefit/risk profile, of note, I think it's important to say that the submission that we had in Europe was exactly the same as what we had in the United States, and we stand behind the European decision, the label that they granted.
正如我在安全收益/風險簡介中所說,我們繼續相信,值得注意的是,我認為重要的是要說我們在歐洲的提交與我們在美國的提交完全相同,我們支持歐洲的決定,他們授予的標籤。
As we look at other studies, in clinical studies, we actually are continuing those.
當我們查看其他研究時,在臨床研究中,我們實際上正在繼續這些研究。
Obviously, we'll take into account our discussions with the FDA, but we are looking at continuing those studies and starting a Phase III trial in psoriatic arthritis by the end of this year.
顯然,我們將考慮與 FDA 的討論,但我們正在考慮繼續這些研究,並在今年年底前開始銀屑病關節炎的 III 期試驗。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Thanks, Christi.
謝謝,克里斯蒂。
And Dave?
戴夫呢?
David A. Ricks - CEO, President and Director
David A. Ricks - CEO, President and Director
Yes.
是的。
Sure.
當然。
Thanks.
謝謝。
I think, Jami, your question is, if I heard it right, is would we undertake some very large cost restructuring programs that certainly could make a one-time move in operating margins.
我想,Jami,你的問題是,如果我沒聽錯的話,我們是否會進行一些非常大規模的成本重組計劃,這些計劃肯定可以一次性提高營業利潤率。
Right now, under the scenario we see and per the discussion that we also had with Derica today, we see a continuous top line revenue growth driven by new products.
目前,在我們看到的情況下,根據我們今天與 Derica 的討論,我們看到新產品推動的收入持續增長。
And the kind of performance we put up in Q1, if we just compound that out, I think will yield impressive margin gains.
我們在第一季度的表現,如果我們把它複合起來,我認為將產生可觀的利潤增長。
Reminding people, we had 7% top line, 3% cost growth, yielding 18% income growth.
提醒人們,我們的收入增長了 7%,成本增長了 3%,收入增長了 18%。
That, I think if we can compound that over the next several years, you'll be (inaudible) a top-tier financial performance out of Lilly, and that's what we're focused on rather than try to have some disruptive event that would perhaps set us back in terms of revenue growth and R&D productivity.
那,我認為如果我們能在未來幾年內復合,你將(聽不清)禮來公司的頂級財務業績,這就是我們關注的重點,而不是試圖發生一些破壞性事件也許在收入增長和研發生產力方面讓我們倒退。
So right now, that's what we're focused on.
所以現在,這就是我們所關注的。
Of course, we have scenarios, as Derica described, that have different mixes of products that get us to that 5% average top line.
當然,正如 Derica 所描述的,我們有不同的產品組合使我們達到 5% 的平均收入。
Some scenarios could get us well above it.
有些情況可以讓我們遠遠超過它。
We're very comfortable with that guidance now.
我們現在對這種指導感到非常滿意。
Jamilu E. Rubin - Equity Analyst
Jamilu E. Rubin - Equity Analyst
But just to be clear, Dave, the improvement in operating margin is highly dependent on top line growth and top line mix as opposed to any cuts to operating expenses?
但需要明確的是,戴夫,營業利潤率的提高很大程度上取決於營收增長和營收組合,而不是削減運營費用?
David A. Ricks - CEO, President and Director
David A. Ricks - CEO, President and Director
Yes, it's primarily based on the top line growth, that's right.
是的,它主要基於收入增長,沒錯。
If you do the math, there are targeted cost reductions which we're -- have met, and we'll continue to undertake to reshape the company and make it as competitive as it needs to be as well as service the R&D engine as well as the launches that are underway.
如果你算一算,我們已經實現了有針對性的成本降低,我們將繼續致力於重塑公司,使其具有所需的競爭力,並為研發引擎提供服務作為正在進行的發射。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
John, if we can go to the next caller, please.
約翰,如果我們可以去找下一位來電者,請。
Operator
Operator
And we'll go to Steve Scala with Cowen.
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
A few questions.
幾個問題。
First, on Jardiance.
首先,關於 Jardiance。
Would you speak specifically to the disconnect between revenue and scripts in Q1?
您能具體談談第一季度收入和劇本之間的脫節嗎?
I'm not sure that was fully explained.
我不確定這是否得到了充分解釋。
Secondly, I appreciate that you have not met with the FDA yet on baricitinib, but based solely on what's in the CRL and Lilly's interpretation of it, when would Lilly be in a position to answer FDA questions?
其次,我感謝您尚未就巴瑞替尼與 FDA 會面,但僅根據 CRL 中的內容和禮來對其的解釋,禮來何時能夠回答 FDA 的問題?
Would that be a 2017 event or a 2018 event?
那是 2017 年的活動還是 2018 年的活動?
And then lastly, would you elaborate on the dynamics around the JUNIPER trial of abemaciclib in lung cancer?
最後,您能否詳細說明一下 JUNIPER 對 abemaciclib 在肺癌中的試驗的動態?
The primary completion has moved a couple of times now.
主要完成現在已經移動了幾次。
One interpretation could be that Lilly is cutting its losses and giving up, but maybe you can clarify.
一種解釋可能是禮來公司正在減少損失並放棄,但也許你可以澄清一下。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Thank you for the questions.
謝謝你的提問。
So Enrique, we'll go to you for the Jardiance question on the disconnect between TRx and revenue, Christi for the question on the baricitinib, the response letter, and then over to Sue for the JUNIPER study with abemaciclib in lung cancer.
因此,Enrique,我們將向您詢問有關 TRx 與收入之間脫節的 Jardiance 問題,Christi 詢問有關 baricitinib 的問題,回复信,然後交給 Sue 進行 JUNIPER 與 abemaciclib 在肺癌中的研究。
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
Well, we don't think there's a disconnect between TRx and revenue.
好吧,我們認為 TRx 和收入之間沒有脫節。
The quarter was -- for Jardiance was pretty clean.
這個季度是——因為 Jardiance 非常乾淨。
So we didn't have changes in estimates when it comes to rebates and discounts.
因此,在回扣和折扣方面,我們的估計沒有變化。
Let's recall, of course, in the case of Jardiance, we share 50-50 the gross margin for the product with the BI; that's the way basically, what we book as revenue.
讓我們回想一下,當然,在 Jardiance 的情況下,我們與 BI 分享 50-50 的產品毛利率;基本上就是這樣,我們將其記為收入。
And right now, I think it's fair to say that the current revenue basically, is a good reflection of the underlying scripts.
而現在,我認為可以公平地說,目前的收入基本上很好地反映了底層腳本。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Great.
偉大的。
Thanks, Enrique.
謝謝,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
Yes.
是的。
In terms of the bari timing, it's -- really, we can't give you an estimate on whether it's this year or next year until we meet with the FDA, which we are hoping we will do within the next 60 days.
就巴里時間而言,實際上,在我們與 FDA 會面之前,我們無法估計是今年還是明年,我們希望我們能在接下來的 60 天內完成。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Christi, thank you very much.
克里斯蒂,非常感謝。
Sue?
起訴?
Susan Mahony - SVP and President of Lilly Oncology
Susan Mahony - SVP and President of Lilly Oncology
Yes, with regards to the JUNIPER study, no, we are continuing with that study and are very interested in the role of the CDK 4 and 6 in KRAS mutation positive lung cancer.
是的,關於 JUNIPER 研究,不,我們正在繼續該研究,並且對 CDK 4 和 6 在 KRAS 突變陽性肺癌中的作用非常感興趣。
We have made some changes to the study to ensure enrollment and to ensure that it hits the -- a high bar, given the changes that we've seen in FDA guidance and labeling on erlotinib.
鑑於我們在 FDA 指南和厄洛替尼標籤上看到的變化,我們對這項研究進行了一些更改,以確保入組並確保它達到一個高標準。
But we continue that study and are actively enrolling it.
但我們繼續這項研究,並正在積極招收它。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Great.
偉大的。
Thank you, Sue.
謝謝你,蘇。
John, next caller, please.
約翰,請下一位來電。
Operator
Operator
And we'll go to Chris Schott with JPMorgan.
我們將與摩根大通一起去克里斯肖特。
Christopher Thomas Schott - Senior Analyst
Christopher Thomas Schott - Senior Analyst
Just had 2 questions here, both on diabetes.
在這裡只有兩個問題,都是關於糖尿病的。
Maybe first on Humalog.
也許首先在 Humalog 上。
With biosimilars coming to market in 2018, 2019, can you maybe compare and contrast some of the dynamics of the rapid acting market versus what we're just seeing right now with the basal market, where you've launched Basaglar and it's done very well from a share perspective?
隨著生物仿製藥在 2018 年和 2019 年上市,您能否將快速作用市場的一些動態與我們現在剛剛看到的基礎市場進行比較和對比,基礎市場您已經推出了 Basaglar,並且做得很好從份額的角度?
And the second question was more broadly just discussing longer term, your latest longer-term views on diabetes pricing.
第二個問題更廣泛地討論了您對糖尿病定價的最新長期觀點。
The Street seems to be concerned here with a kind of market that's been in flux over the past few years.
華爾街似乎關心的是一種過去幾年一直在變化的市場。
Lilly has obviously benefited from its broader portfolio, but your competitors have struggled.
禮來顯然受益於其更廣泛的產品組合,但您的競爭對手一直在苦苦掙扎。
So, the question is, just longer-term, do you see the pricing dynamics continuing to erode or even get worse?
所以,問題是,就長期而言,您是否看到定價動態繼續削弱甚至變得更糟?
Or could we see dynamics stabilize a bit here as we've gone through at least a few of these categories' pretty aggressive price competition?
或者我們是否可以看到這裡的動態有點穩定,因為我們至少經歷了其中一些類別相當激烈的價格競爭?
Does that at some point stabilize?
這在某個時候會穩定嗎?
Or are you preparing for an environment where things continue to be challenging?
或者您是否正在為一個充滿挑戰的環境做準備?
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Great.
偉大的。
Thank you, Chris, for the questions.
謝謝你,克里斯,你的問題。
Enrique, they're both for you.
恩里克,他們都適合你。
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 that's -- the first question is an interesting one because clearly, we are on both sides of that equation, so we're going to -- you can imagine, we're going to take all the learnings of the launch of Basaglar as we think about how do we ensure that we protect our Humalog franchise.
所以這是 - 第一個問題是一個有趣的問題,因為很明顯,我們在這個等式的兩邊,所以我們將 - 你可以想像,我們將把推出 Basaglar 的所有經驗作為我們考慮如何確保我們保護我們的 Humalog 特許經營權。
It is fair to say that Humalog has a slightly different makeup in terms of we think of the product, as you know, it's not just the rapid acting but it's also the mixtures, which are about 30% of the volume.
公平地說,就我們對產品的看法而言,Humalog 的構成略有不同,如您所知,它不僅是快速作用,而且是混合物,約佔體積的 30%。
Clearly, we do have a strong position when it comes to payers.
顯然,在付款人方面,我們確實處於強勢地位。
And importantly, the contracting already is on exclusive status for really mealtime insulins across all of the major plans.
重要的是,該合同已經在所有主要計劃中處於真正進餐時間胰島素的獨家地位。
That is different from the type of contracting when it comes to basal insulins, where basically, we had a number of products in formularies.
這與基礎胰島素的合同類型不同,基本上,我們在處方集中有許多產品。
So anytime that you basically narrow the formulary, there's an opportunity for a payer to have an economic benefit from a larger rebate.
因此,只要您基本上縮小了範圍,付款人就有機會從更大的回扣中獲得經濟利益。
So the dynamics are a little bit different.
所以動態有點不同。
We clearly are preparing and thinking through that, and I won't be able to comment more on that, but I do think that our position with Humalog is quite strong.
我們顯然正在準備和考慮這一點,我無法對此發表更多評論,但我確實認為我們在 Humalog 的地位非常強大。
When it comes to diabetes pricing, what we basically see is a continuation of the current trends.
在糖尿病定價方面,我們基本上看到的是當前趨勢的延續。
So we don't see significant step changes.
所以我們看不到重大的步驟變化。
We basically see, at this point in time, different classes are in different stages.
我們基本上看到,在這個時間點,不同的班級處於不同的階段。
As I just mentioned, mealtime insulins, we are basically -- all major plans have made a one-of-one exclusive-type decision when it comes to a mealtime insulin.
正如我剛才提到的,餐時胰島素,我們基本上 - 所有主要計劃在餐時胰島素方面都做出了一對一的排他性決定。
But SGLT2s, there's 1 of 2 status for most plans.
但是 SGLT2s,大多數計劃都有 2 個狀態中的 1 個。
GLP-1s is something similar.
GLP-1s 是類似的。
So what we basically see is a continuation of trends rather than a step change.
所以我們基本上看到的是趨勢的延續,而不是階梯式的變化。
Clearly, we are pretty well positioned, given the breadth of our portfolio and really strong share and momentum that we have with our product, which is key as different payers make their formulary decisions.
顯然,鑑於我們的產品組合的廣度以及我們在產品中擁有的真正強大的份額和勢頭,我們處於非常有利的位置,這對於不同的付款人做出他們的處方決定至關重要。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Great.
偉大的。
Thank you, Enrique.
謝謝你,恩里克。
John, if we can go to the next caller, please.
約翰,如果我們可以去找下一位來電者,請。
Operator
Operator
We'll go to Geoff Meacham with Barclays.
我們將和巴克萊一起去 Geoff Meacham。
Geoffrey Christopher Meacham - MD and Senior Research Analyst
Geoffrey Christopher Meacham - MD and Senior Research Analyst
On Taltz, I wonder if you can talk about the new-to-brand share trends in the U.S., say, over the past 6 months.
在 Taltz 上,我想知道你是否可以談談過去 6 個月在美國的新品牌份額趨勢。
Are there many plans that are, that you still don't have formulary status in?
是否有許多計劃,您仍然沒有處方集?
And then in Europe, can you speak to countries that you expect to come on board fully for this calendar year?
然後在歐洲,您能否與您希望在本日曆年全面加入的國家進行交流?
And then on baricitinib, I know it's hard to say, but were extension studies for all of the pivotals part of the filing?
然後關於巴瑞克替尼,我知道這很難說,但文件中所有關鍵部分的延伸研究都包括在內嗎?
I'm just trying to figure out what data haven't yet been submitted or analysis not yet done that you could add that would be new to the CRL.
我只是想弄清楚哪些數據尚未提交或分析尚未完成,您可以將其添加到 CRL 中。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Great, Geoff, thank you very much.
太好了,傑夫,非常感謝。
Christi, if you want to take the first question on the Taltz new-to-brand trends.
克里斯蒂,如果你想回答第一個關於 Taltz 新品牌趨勢的問題。
And feel free if you want IR to answer the second question.
如果您希望 IR 回答第二個問題,請隨意。
We're happy to help with that one as well.
我們也很樂意為此提供幫助。
Christi Shaw - SVP and President of Lilly Bio-Medicines
Christi Shaw - SVP and President of Lilly Bio-Medicines
Sure.
當然。
So the data -- coming new to Lilly, obviously, the data we saw in Taltz in these studies plays out in the marketplace.
所以數據——對於禮來來說是新的,很明顯,我們在這些研究中在 Taltz 看到的數據在市場上發揮了作用。
It's really remarkable, the PASI 100 data and how physicians are seeing the benefits play out with patients in their offices.
非常了不起的是,PASI 100 數據以及醫生如何在他們的辦公室看到患者的益處。
And that what's really leading to the NBRx share gains and growth.
這才是真正導致 NBRx 股票收益和增長的原因。
The growth continues.
增長仍在繼續。
As you probably know, we passed Enbrel early last year.
您可能知道,我們去年初通過了 Enbrel。
We passed C OSENTYX later in the year.
我們在當年晚些時候通過了 C OSENTYX。
We continue to believe that the IL-17s are the best-in-class and a huge market opportunity for us as we close the NBRx share on Stelara.
隨著我們關閉 Stelara 的 NBRx 份額,我們仍然相信 IL-17 對我們來說是一流的和巨大的市場機會。
And that, in spite of not having a lot of formulary access with all of the payers.
而且,儘管所有付款人都沒有大量的處方集訪問權限。
So we continue to work on that.
所以我們繼續努力。
So yes, there is opportunity to grow in that area.
所以是的,在那個領域有發展的機會。
Derica W. Rice - CFO and EVP of Global Services
Derica W. Rice - CFO and EVP of Global Services
In terms of the data that was submitted, Geoff, so there were data obviously from the 4 pivotal studies as well us from data we wouldn't have had at the time and I believe over the course of the review from the extension study.
就提交的數據而言,Geoff,因此顯然有來自 4 項關鍵研究的數據以及我們當時不會擁有的數據,我相信在擴展研究的審查過程中。
There is additional data that we have generated in the extension study that we're mentioning that we have not submitted to the FDA.
我們在擴展研究中產生了額外的數據,我們提到我們尚未提交給 FDA。
As Christi talked about earlier, we'll look forward to meeting with the FDA here in the next 60 days or so to see if any of the additional data that we have could be helpful to them in their consideration of the safety concerns that they raised in the Complete Response Letter.
正如克里斯蒂早些時候所說,我們期待在接下來的 60 天左右與 FDA 會面,看看我們掌握的任何其他數據是否有助於他們考慮他們提出的安全問題在完整的回复信中。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
John, if we can go to the next caller, please?
約翰,如果我們可以去找下一位來電者,好嗎?
Operator
Operator
And we'll go to Tony Butler with Guggenheim Securities.
我們將與古根海姆證券一起去托尼巴特勒。
Charles Anthony Butler - Senior Analyst
Charles Anthony Butler - Senior Analyst
Two brief questions.
兩個簡短的問題。
Cyramza in Japan has been, perhaps, the better geographic growth driver for the product.
日本的 Cyramza 也許是該產品更好的地理增長動力。
However, quarter-to-quarter, it does look as if it had peaked in Q4, and I'm curious if that is, in fact, the case, being down in Q1.
但是,按季度來看,它確實似乎在第四季度達到頂峰,我很好奇這是否真的是這樣,在第一季度有所下降。
And Enrique, again back to, I guess, Steve Scala's question on Jardiance.
恩里克,我想,再一次回到史蒂夫斯卡拉關於 Jardiance 的問題。
Also, or similarly, the Q4 to Q1, at least Lilly's share of the gross profit is effectively flat and slightly down.
同樣,或類似地,從第四季度到第一季度,至少禮來在毛利潤中的份額實際上持平並略有下降。
Is it because demand is in a lower revenue generating channel, for example, perhaps more Medicaid patients being prescribed the product than maybe those from managed care?
是因為需求處於較低的創收渠道,例如,可能有更多的醫療補助患者被開出該產品,而不是那些來自管理式醫療的患者?
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Great, Tony.
太好了,托尼。
Thanks for the questions.
感謝您的提問。
Sue for the Cyramza Japan question, and then Enrique for the Jardiance follow up.
為 Cyramza Japan 問題起訴,然後 Enrique 為 Jardiance 跟進。
Susan Mahony - SVP and President of Lilly Oncology
Susan Mahony - SVP and President of Lilly Oncology
Hi, Tony.
嗨,托尼。
Yes, thanks very much for the question on Cyramza in Japan.
是的,非常感謝關於日本 Cyramza 的問題。
You're right, it is going very well in Japan.
你是對的,它在日本進展順利。
The quarter-on-quarter is just the timing.
季度環比只是時機。
If you look at last year, you would have seen the same dynamics.
如果你看看去年,你會看到同樣的動態。
What we are continuing to see is strong growth of Cyramza in Japan in the gastric cancer indication, where it now has a market share of 57%.
我們繼續看到的是 Cyramza 在日本在胃癌適應症方面的強勁增長,目前它的市場份額為 57%。
In fact, I think Cyramza is one of the most successful oncology launches now in Japan.
事實上,我認為 Cyramza 是目前日本最成功的腫瘤學產品之一。
We also are now seeing uptake in both the lung and the colorectal cancer indications.
我們現在也看到了在肺癌和結直腸癌適應症中的應用。
There's a quite high level of -- as you know, the prevalence in Japan of gastric cancer, is a lot higher than the U.S., and we are seeing a lot of overlap between uses of Cyramza in gastric cancer and those that treat colorectal cancer.
如您所知,日本的胃癌患病率非常高,遠高於美國,我們看到 Cyramza 在胃癌和結直腸癌治療中的應用之間有很多重疊。
And so we see a good opportunity for uptake in that indication too.
因此,我們也看到了吸收這一跡象的好機會。
We are currently seeing that and also in lung.
我們目前正在看到這一點,也在肺部。
So we feel very good about the continued uptake of Cyramza in Japan.
因此,我們對 Cyramza 在日本的持續採用感到非常滿意。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
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
Yes, there's really not an issue when it comes, Tony, to segment mix.
是的,托尼,分段混合真的沒有問題。
We had in Q4 of 2016, a positive benefit, roughly about $15 million worth of Lilly revenue due to changes in the estimates of rebates and discounts and co-pay cards.
我們在 2016 年第四季度獲得了積極的收益,禮來公司的收入約為 1500 萬美元,這是由於對回扣和折扣以及共同支付卡的估計發生變化。
So that's basically why that comparison doesn't follow the script trend.
所以這基本上就是為什麼這種比較不符合腳本趨勢的原因。
If anything, we should see basically improved pricing when it comes to Jardiance just because we made some changes to our co-pay cards.
如果有的話,我們應該看到 Jardiance 的定價基本得到改善,因為我們對共同支付卡進行了一些更改。
So our -- we are going to be less reliant on them as time goes through.
因此,隨著時間的推移,我們將減少對它們的依賴。
So that should basically give us some benefit, over time, when it comes to the nebulized prices that we see.
因此,隨著時間的推移,當涉及到我們看到的霧化價格時,這基本上應該會給我們帶來一些好處。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Thank you, Enrique.
謝謝你,恩里克。
John, if we can go to the next caller.
約翰,如果我們可以去找下一位來電者。
Operator
Operator
And that will be David Risinger with Morgan Stanley.
那將是摩根士丹利的 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
Yes, I'm restrained as many of my peers, and instead, Phil, I'll follow your instructions and ask 2 questions.
是的,我和我的許多同齡人一樣受到限制,相反,菲爾,我會按照你的指示問兩個問題。
First, Dave, could you please discuss near-term M&A opportunities to acquire small biotech companies with new launch prospects in order to enhance your new launch pipeline flow late decade?
首先,戴夫,您能否討論一下近期併購機會,以收購具有新上市前景的小型生物技術公司,以增強您的新上市管道流量?
And then second, Enrique, I was actually surprised with Jardiance that given its extraordinary cardiovascular benefit, which is actually better than many drugs that are solely approved for cardiovascular disease, I would have thought that Lilly would have gone to payers and said to payers, we need to reduce our rebate payments to you.
其次,Enrique,我實際上對 Jardiance 感到驚訝,因為它具有非凡的心血管益處,實際上比許多僅批准用於心血管疾病的藥物要好,我原以為禮來會去找付款人,並對付款人說,我們需要減少向您支付的回扣。
Obviously, from an ethical standpoint, Jardiance has to be Tier 2 irrespective of rebates.
顯然,從道德的角度來看,無論回扣如何,Jardiance 都必須是第 2 層。
And so, I guess, I'm just hoping that you could provide a little bit more color on why Lilly has to enhance rebates for such an extraordinary drug?
所以,我想,我只是希望你能提供更多關於為什麼禮來必須提高這種非凡藥物的回扣的色彩?
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Great, Dave.
太好了,戴夫。
Thank you for the 2 questions.
謝謝你的2個問題。
Dave, we'll go to you for the near-term M&A question, and then back to Enrique for the Jardiance question.
戴夫,我們會問你近期的併購問題,然後回到恩里克的 Jardiance 問題。
David A. Ricks - CEO, President and Director
David A. Ricks - CEO, President and Director
Yes, thanks, Dave.
是的,謝謝,戴夫。
Well, our posture on M&A really hasn't changed.
好吧,我們對併購的態度確實沒有改變。
It's a top priority for deployment of capital.
這是資本配置的重中之重。
Of course, we are very interested in targets that would enhance our position, whether it be pipeline or otherwise in oncology, diabetes, immunology or in Alzheimer's or pain.
當然,我們對能夠提高我們地位的目標非常感興趣,無論是管道還是其他腫瘤學、糖尿病、免疫學或阿爾茨海默氏症或疼痛。
When we see those things, we move quickly.
當我們看到這些東西時,我們會迅速行動。
I think CoLucid is an example of that.
我認為 CoLucid 就是一個例子。
The reality in the world, though, is I think that there are constraints.
然而,世界的現實是,我認為存在限制。
And one of them is pricing.
其中之一就是定價。
We're not the only company looking for these assets.
我們不是唯一一家尋找這些資產的公司。
The other is strategic fit, we're going to be disciplined to stick to therapeutic areas where we have an ongoing interest, we think where we have information advantage, and we want to trade on that.
另一個是戰略契合,我們將遵守紀律,堅持我們有持續興趣的治療領域,我們認為我們有信息優勢,我們希望在此基礎上進行交易。
And then I think the asset fit within our pipeline, when you're talking about pipeline assets, we seek to acquire things that can be producing interesting combinations or fill gaps.
然後我認為資產適合我們的管道,當你談論管道資產時,我們尋求獲得可以產生有趣組合或填補空白的東西。
So we're very focused on this space.
所以我們非常關注這個領域。
Obviously, we had one transaction in Q1.
顯然,我們在第一季度有一筆交易。
I hope we can find more like it not because we see a lot of value in CoLucid, as an example.
我希望我們能找到更多類似的東西,而不是因為我們在 CoLucid 中看到了很多價值,例如。
But it's a top priority for me and we continue to scour the planet for good opportunities to add to Lilly's growth story.
但這對我來說是重中之重,我們將繼續在地球上搜尋為禮來的成長故事增添新意的好機會。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
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
Tim, I agree in that Jardiance is indeed compelling value for payers.
蒂姆,我同意 Jardiance 對於付款人來說確實具有令人信服的價值。
I am unable to discuss what our rebate strategy is on this forum, but I think it's important.
我無法在這個論壇上討論我們的回扣策略是什麼,但我認為這很重要。
We do have some -- there's, of course, public knowledge when it comes to, for example, Germany and Japan, and in both of those cases, in the case of Germany, we have a new price, a higher price for Jardiance based on the indication.
我們確實有一些——當然,當涉及到德國和日本時,公眾知道,在這兩種情況下,就德國而言,我們有一個新的價格,一個更高的基於 Jardiance 的價格在指示上。
In the case of Japan, we did not get the price cut.
在日本,我們沒有降價。
We got a minor, a positive price adjustment.
我們得到了一個小的、積極的價格調整。
But yes, we do believe that this product offers compelling value to payers and to patients.
但是,是的,我們確實相信該產品為付款人和患者提供了令人信服的價值。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Thank you, Enrique.
謝謝你,恩里克。
John, if we can go to the next caller, please.
約翰,如果我們可以去找下一位來電者,請。
Operator
Operator
And that will be Umer Raffat with Evercore.
那將是與 Evercore 的 Umer Raffat。
Umer Raffat - Senior MD and Fundamental Research Analyst
Umer Raffat - Senior MD and Fundamental Research Analyst
So I wanted to ask directly, do think you need a new trial for bari, number one?
所以我想直接問,你認為你需要對 bari 進行新的試驗嗎?
And number two, in a scenario, let's say there's a scenario where only 2-milligram dose is approved, do you think bari would be able to get the head-to-head versus Humira on label?
第二,在一個場景中,假設只有 2 毫克的劑量被批准,你認為 bari 能夠在標籤上與 Humira 進行正面交鋒嗎?
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Could you hear it?
你能聽到嗎?
Were those 2 questions, Umer?
是那兩個問題嗎,Umer?
I'm not sure if you were cut out or if that was the 2 questions.
我不確定你是被刪掉了還是這兩個問題。
Umer Raffat - Senior MD and Fundamental Research Analyst
Umer Raffat - Senior MD and Fundamental Research Analyst
I'm so sorry.
我很抱歉。
So let me try again.
所以讓我再試一次。
First of all, I just wanted to ask directly, do you think you need a new trial on bari?
首先,我只是想直接問一下,你認為你需要對bari進行新的試驗嗎?
And number two, in a scenario where only a 2-milligram dose is approved, do you think you'll be able to get the superiority language versus Humira on label?
第二,在只批准 2 毫克劑量的情況下,你認為你能在標籤上獲得優於修美樂的語言嗎?
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Christi, you'd like to handle those?
克里斯蒂,你想處理這些嗎?
Christi Shaw - SVP and President of Lilly Bio-Medicines
Christi Shaw - SVP and President of Lilly Bio-Medicines
Sure.
當然。
So we don't know what we'll need until we actually meet with the FDA.
因此,在我們真正與 FDA 會面之前,我們不知道我們需要什麼。
As I said before, we believe in the benefit/risk profile of the 4 milligrams and the 2 milligrams across dosage groups, and that's what we continue to see with the data.
正如我之前所說,我們相信 4 毫克和 2 毫克跨劑量組的益處/風險概況,這就是我們繼續從數據中看到的。
And we want to make sure that what we provide to the marketplace is something that is effective and safe for the patients that it serves.
我們希望確保我們向市場提供的東西對於它所服務的患者來說是有效和安全的。
So right now, we're looking at a 4-milligram and 2-milligram and open to the discussions with the FDA, and we'll see how they go and be back to you after that.
所以現在,我們正在研究 4 毫克和 2 毫克的藥物,並願意與 FDA 進行討論,我們將看看它們的進展情況並在之後回复您。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Thank you, Christi.
謝謝你,克里斯蒂。
David A. Ricks - CEO, President and Director
David A. Ricks - CEO, President and Director
And just as a reminder, the R&D study just had the 4-milligram in it against Humira.
提醒一下,研發研究中只有 4 毫克對修美樂。
So I think if that's your question, just to remind you, of that particular study.
所以我想如果這是你的問題,只是為了提醒你,那個特定的研究。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
OK, thanks, Dave.
好的,謝謝,戴夫。
John, next caller, please.
約翰,請下一位來電。
Operator
Operator
And we'll go to Alex Arfaei with BMO Capital Markets.
我們將與 BMO Capital Markets 聯繫 Alex Arfaei。
Ardalan Alex Arfaei - Pharmaceuticals Analyst
Ardalan Alex Arfaei - Pharmaceuticals Analyst
Most of my questions have been asked.
我的大部分問題都被問到了。
A couple more for Enrique in diabetes.
恩里克在糖尿病方面還有更多。
First on Humalog, how comfortable are you about the sustainability of the exclusive arrangements that you have with payers?
首先在 Humalog 上,您對與付款人的獨家安排的可持續性感到滿意嗎?
Because the economic benefit that you mentioned from the rebates, that's obviously has come under increased scrutiny.
因為你提到的回扣帶來的經濟利益,這顯然受到了更嚴格的審查。
So what are the risks there?
那麼那裡有什麼風險呢?
And then following up, obviously, Trulicity's doing well.
然後跟進,顯然,Trulicity 做得很好。
What is your competitive outlook there on the GLP-1 class, particularly from the oral GLP-1 in Phase III from Novo?
您對 GLP-1 類別的競爭前景如何,尤其是來自 Novo 的 III 期口服 GLP-1?
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Great, Alex.
太好了,亞歷克斯。
Thank you very much for the question.
非常感謝您的提問。
Enrique, again to you.
恩里克,再次給你。
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 clearly, as we contract with the payers, we -- it's not only the economic benefit but, of course, all of the clinical benefits of each one of the products.
很明顯,當我們與付款人簽訂合同時,我們 - 這不僅是經濟利益,當然還有每一種產品的所有臨床利益。
In the case of Humalog, it's always difficult to say as we go through the contracting season, but I think what we can say is as we looked at historically, once a payer has made a decision on a particular product, basically, once it comes time to renew, they typically have continued with that choice that they initially made.
在 Humalog 的情況下,在我們經歷合同季節時總是很難說,但我認為我們可以說的是從歷史上看,一旦付款人對特定產品做出決定,基本上,一旦它來了是時候更新了,他們通常會繼續他們最初做出的選擇。
In particular, when there are not new entrants basically coming into the mix.
特別是,當基本上沒有新進入者進入時。
So we see this not only in diabetes but I think in other therapeutic classes.
因此,我們不僅在糖尿病中看到了這一點,而且我認為在其他治療類別中也是如此。
As you can imagine, for -- if we have a market where we have 2 major players, in this particular case, maybe Lilly and Novo, and we were in dual status, and we go to exclusive status, you are switching 50% of the patients.
正如你可以想像的那樣,如果我們的市場有兩個主要參與者,在這種特殊情況下,可能是禮來和諾和,我們處於雙重狀態,我們進入獨家狀態,你正在轉換 50%患者。
But once somebody is on exclusive status, now you basically -- the disruption is significantly higher, and clearly, the economics from a benefit of the rebate perspective are really not going to be there because they are already getting basically top exclusive rights.
但是一旦有人處於獨家地位,現在你基本上 - 破壞性明顯更高,而且很明顯,從回扣的角度來看,經濟學真的不會存在,因為他們已經基本上獲得了頂級獨家權利。
When it comes to Trulicity, clearly, the product is doing extremely well.
當談到 Trulicity 時,很明顯,該產品的表現非常好。
We are very excited about the overall growth of the class.
我們對班級的整體發展感到非常興奮。
So we see significant expansion of the GLP-1 class continuing.
因此,我們看到 GLP-1 類別的顯著擴展仍在繼續。
And of course, Trulicity has superior share performance within that class.
當然,Trulicity 在該類別中具有出色的股票表現。
We do see additional competition coming in both -- when it comes to semaglutide as well as the oral GLP-1.
我們確實看到了額外的競爭——在 semaglutide 和口服 GLP-1 方面。
Of course, we need to wait for additional data on what type of label would these products get.
當然,我們需要等待有關這些產品將獲得什麼類型標籤的更多數據。
Clearly, the efficacy of sema is, we believe, very good, but they also had a signal when it comes to retinopathy, so we need to see what is their label going to look like because we do think that it's not just efficacy but the entire profile.
顯然,我們認為 sema 的功效非常好,但它們在視網膜病變方面也有信號,所以我們需要看看它們的標籤會是什麼樣子,因為我們確實認為這不僅僅是功效,而是整個配置文件。
And finally, one of the great benefits that Trulicity, I think, is offering is we basically feel that Trulicity's almost redefining the first injection experience because patients don't have to touch the needle or see the needle in a certain way.
最後,我認為,Trulicity 提供的一大好處是,我們基本上認為 Trulicity 幾乎重新定義了第一次注射體驗,因為患者不必以某種方式觸摸針頭或看到針頭。
The feedback that we get from the experience, I think, is just fantastic.
我認為,我們從體驗中獲得的反饋非常棒。
We've said that we are interested in oral GLP-1s, and that's something that we're actively working on.
我們已經說過我們對口服 GLP-1 感興趣,這是我們正在積極開展的工作。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Great.
偉大的。
Thank you, Enrique.
謝謝你,恩里克。
John, next caller, please.
約翰,請下一位來電。
Operator
Operator
And that will be Vamil Divan with Credit Suisse.
那將是瑞士信貸的 Vamil Divan。
Vamil Kishore Divan - Senior Analyst
Vamil Kishore Divan - Senior Analyst
So one -- just follow-up on the diabetes side, can you give us a sense of the share now for the SGLT2s and the GLP-1s that's coming from primary care physicians as opposed to specialists.
所以一個 - 只是在糖尿病方面的後續行動,您能否讓我們了解現在來自初級保健醫生而不是專家的 SGLT2 和 GLP-1 的份額。
I guess, if you want to throw the DPP-4s in there as well, that would be helpful.
我想,如果你也想把 DPP-4 扔進去,那會很有幫助。
And then my second question, just on the 2017 guidance, I just wanted to clarify, I believe you have not incorporated any expectations around the potential approval from KEYNOTE-021G for Alimta in combination with carbo and Keytruda.
然後我的第二個問題,只是關於 2017 年的指導,我只是想澄清一下,我相信你沒有對 KEYNOTE-021G 對 Alimta 與 carbo 和 Keytruda 的潛在批准有任何期望。
Is that -- can you just confirm that's correct and would that then be upside if that approval does come next month?
那是 - 你能確認這是正確的嗎?如果下個月獲得批准,那會不會有好處?
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Okay, Vamil.
好的,瓦米爾。
Thank you very much for the questions.
非常感謝您的提問。
Enrique, if you'd like to handle the question with regard to split between PCP and specialists for SGLT2s, and DPP-4s as well, if you have it.
Enrique,如果您想處理有關在 SGLT2 和 DPP-4 的 PCP 和專家之間拆分的問題,如果您有的話。
And then Derica, any comment you have on how the KEYNOTE-021G approval, if that comes through, could impact our expectations for '17.
然後是 Derica,如果您對 KEYNOTE-021G 的批准有何評論,如果獲得批准,可能會影響我們對 17 年的預期。
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, so when it comes to orals, SLGT2s and DPP-4 are pretty alike.
是的,所以說到口腔,SLGT2 和 DPP-4 非常相似。
We basically see primary care basically driving about 80% of the overall scripts.
我們基本上看到初級保健基本上驅動了大約 80% 的整體腳本。
Now we -- one thing that we've been watching is basically where -- what about cardiologists, and what we basically see is that while cardiologists, in the case of Jardiance, are a significant source of authority, and while we have seen an increase, the base of prescribing is extremely, extremely small.
現在我們 - 我們一直在關注的一件事基本上是在哪裡 - 心髒病專家呢,我們基本上看到的是,雖然心髒病專家,在 Jardiance 的案例中,是一個重要的權威來源,雖然我們已經看到了增加,開藥的基數極小極小。
I don't have the actual split for the GLP-1s, and I'm cautious about making it because that class has been evolving very, very quickly.
我沒有 GLP-1 的實際拆分,我對製作它持謹慎態度,因為該類別的發展非常非常迅速。
And what we basically see is huge growth when it comes to primary care right now.
我們現在基本上看到的是初級保健領域的巨大增長。
But that class used to be about 50-50, and I will provide the specifics of where we are now.
但是那個班級過去大約是 50-50,我將提供我們現在所處位置的細節。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Great.
偉大的。
Thank you, Enrique.
謝謝你,恩里克。
Derica?
德麗卡?
Derica W. Rice - CFO and EVP of Global Services
Derica W. Rice - CFO and EVP of Global Services
In regards to the guidance, as you saw in our press release and in our remarks here this morning, we reaffirmed our guidance for 2017.
關於指導,正如您在我們的新聞稿和今天上午的講話中看到的那樣,我們重申了對 2017 年的指導。
As it relates to the KEYNOTE data, we're excited about the data itself.
由於它與 KEYNOTE 數據相關,因此我們對數據本身感到興奮。
We look forward to hearing the feedback and the outcome with the discussions with the FDA.
我們期待聽到與 FDA 討論的反饋和結果。
Clearly, if it's positive, it would go to support that guidance.
顯然,如果它是積極的,它將支持該指導。
But when we put our guidance together, we contemplate, again, as I stated earlier, a number of various scenarios that we will have to contend with, whether it's over the next 12 months in terms of our annual guidance or as it relates to our mid- to longer-term guidance when we're talking about the 5%, and this would just be one of those additional scenarios that's factored in.
但是,當我們將我們的指導放在一起時,我們再次考慮,正如我之前所說,我們將不得不應對許多不同的情況,無論是在未來 12 個月內,就我們的年度指導而言,還是與我們的當我們談論 5% 時,中長期指導,這只是考慮的額外情景之一。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Thanks, Derica.
謝謝,德麗卡。
John, next caller, please.
約翰,請下一位來電。
Operator
Operator
That will be Marc Goodman with UBS.
那將是瑞銀的馬克古德曼。
Marc Harold Goodman - MD and United States Healthcare Analyst
Marc Harold Goodman - MD and United States Healthcare Analyst
Sue, can you talk about how your oncology strategies evolved?
蘇,你能談談你的腫瘤學策略是如何演變的嗎?
And what are the key Phase II assets we should be focused on?
我們應該關注哪些關鍵的第二階段資產?
And then second, just in animal health, can you tell us what was the impact of the BI sales in the quarter from the acquisition?
其次,就動物健康而言,您能告訴我們本季度 BI 銷售對收購產生的影響嗎?
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Okay, Marc.
好的,馬克。
Thank you for the questions.
謝謝你的提問。
Sue, for the oncology strategy question and these highlights on Phase II assets.
蘇,關於腫瘤學戰略問題和第二階段資產的這些亮點。
And then, Jeff, back to you for commentary on the impact of the BI Vetmedica acquisition and the results for the quarter.
然後,傑夫,回复你對 BI Vetmedica 收購的影響和本季度結果的評論。
Sue?
起訴?
Susan Mahony - SVP and President of Lilly Oncology
Susan Mahony - SVP and President of Lilly Oncology
Sure.
當然。
Yes, thanks for the question.
是的,謝謝你的提問。
Clearly, as we look in our -- at our strategy, the oncology environment is changing pretty rapidly, and we want to make sure that as we're looking at agents that we're bringing through, really agents that are standard of care changing or have the potential to be standard of care changing or to be foundational agents.
顯然,當我們審視我們的戰略時,腫瘤學環境正在迅速變化,我們希望確保當我們正在研究我們帶來的代理時,真正改變護理標準的代理或有可能成為改變護理標准或成為基礎代理人。
We believe that we have a number of those.
我們相信我們有很多這樣的。
We just launched Lartruvo for soft tissue sarcoma, which is the first agent that has been approved to show an overall, a survival advantage over standard of care in 40 years.
我們剛剛推出了用於軟組織肉瘤的 Lartruvo,這是第一個被批准在 40 年內顯示出總體生存優勢的藥物。
I'm showing an improvement of 12 months nearly in soft tissue sarcoma, so I think that is one that we can say clearly has the potential to be standard of care changing and foundational.
我在軟組織肉瘤方面表現出近 12 個月的改善,所以我認為這是我們可以清楚地說有可能成為改變護理標準和基礎的一種方法。
We have abemaciclib data that we're excited about, too.
我們也有令人興奮的 abemaciclib 數據。
We have a number of assets in our portfolio.
我們的投資組合中有許多資產。
We're actually currently going through a strategy review and a prioritization and which we are looking forward to giving you more details on over the next months.
實際上,我們目前正在進行戰略審查和優先排序,我們期待在接下來的幾個月內為您提供更多詳細信息。
There are a number of agents that we're excited by it.
有許多代理商對此感到興奮。
I think that we look at our CHK1 inhibitor, Prexasertib, data on that is pretty exciting, and you should see more on that coming through over the next few months as you see how we're continuing to develop that further.
我認為我們查看我們的 CHK1 抑製劑 Prexasertib 的數據非常令人興奮,當您看到我們如何繼續進一步開發時,您應該在接下來的幾個月中看到更多關於這方面的信息。
With regards to our ERK inhibitor, we're pretty excited about that, too.
關於我們的 ERK 抑製劑,我們也對此感到非常興奮。
That's in Phase I at the moment.
目前處於第一階段。
We also have potential combination options with our PI3K/mTOR inhibitor and abemaciclib.
我們也有與我們的 PI3K/mTOR 抑製劑和 abemaciclib 的潛在組合選擇。
So you're going to see more as we continue to roll out our prioritization of our portfolio.
因此,隨著我們繼續推出我們的投資組合優先級,您會看到更多。
We have a number of assets in our portfolio now.
我們現在的投資組合中有許多資產。
What we want to do is really focus on those ones that have the potential to be foundational standard of care changing and have rapid development of those, and that's where our focus is.
我們想要做的是真正關注那些有可能成為改變基礎護理標準并快速發展的那些,這就是我們關注的地方。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Thanks, Sue.
謝謝,蘇。
Jeff?
傑夫?
Jeffrey N. Simmons - SVP and President of Elanco Animal Health
Jeffrey N. Simmons - SVP and President of Elanco Animal Health
Yes, on the impact of the BI, we sold 40.8 million in the first quarter, that's aligned with our plans.
是的,在 BI 的影響下,我們在第一季度售出了 4080 萬台,這與我們的計劃一致。
And again, as mentioned in the results, we were up 2% with the impact of BI.
同樣,正如結果中提到的,我們在 BI 的影響下增長了 2%。
Without it, it was minus 3%.
沒有它,它是-3%。
Derica W. Rice - CFO and EVP of Global Services
Derica W. Rice - CFO and EVP of Global Services
And just, Marc, overall, if you saw from our prepared remarks, that the Vetmedica added about 30 basis points of our overall 8% volume growth in the quarter.
總的來說,馬克,如果你從我們準備好的評論中看到,Vetmedica 在本季度我們整體 8% 的銷量增長中增加了大約 30 個基點。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Great.
偉大的。
Thanks, Derica.
謝謝,德麗卡。
John, next question, please.
約翰,請下一個問題。
Operator
Operator
And we'll go to Jeff Holford with Jefferies.
我們將和傑富瑞一起去傑夫霍爾福德。
Jeffrey Holford - Equity Analyst
Jeffrey Holford - Equity Analyst
So clearly, Trulicity has been having a great launching and is expected to going forward.
很明顯,Trulicity 已經有了一個很好的發布,並有望繼續前進。
But I get a lot of questions from investors just around sustainability of pricing in the GLP-1 segment.
但我從投資者那裡收到了很多關於 GLP-1 細分市場定價可持續性的問題。
So just maybe ask you to gaze into your crystal ball a little bit through maybe the upcoming contracting and 1 or 2 years out, how you just see that potentially being different from the insulin markets, obviously, where pricing pressure has been a bit more difficult.
因此,也許只是要求您通過即將到來的合同以及 1 或 2 年後凝視您的水晶球,您如何看待這可能與胰島素市場不同,顯然,定價壓力有點困難.
And then the second question, just really going back to baricitinib a little bit and the clinical trial design there.
然後是第二個問題,真正回到巴瑞替尼和那裡的臨床試驗設計。
There is quite a lot of crossover in some of those clinical trials and up and down dosing.
在其中一些臨床試驗和上下劑量中存在相當多的交叉。
Just wanted to get any feedback that you can potentially give us on how comfortable the FDA was with that design right from the outset.
只是想從一開始就獲得有關 FDA 對該設計的舒適程度的任何反饋。
And whether any of this crossover and up and down dosing in the trials was potentially discussed at mid-cycle review.
並且在周期中期審查中是否可能討論了試驗中的任何這種交叉和上下劑量。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Jeff, thank you for the questions.
傑夫,謝謝你的提問。
Enrique, if you'll comment on Trulicity pricing question.
Enrique,如果您對 Trulicity 定價問題發表評論。
And then Dave, do you want to take the question for the baricitinib trial design.
然後戴夫,你想回答巴瑞替尼試驗設計的問題嗎?
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。
Just on Trulicity, first, our access right now is of standard, I think it reflects the -- given the clinical and business performance of the product, Trulicity is now basically added in most plans.
就 Trulicity 而言,首先,我們現在的訪問是標準的,我認為它反映了 - 鑑於產品的臨床和業務表現,現在大多數計劃中基本上都添加了 Trulicity。
So our access in both commercial and Part D is north of 80%.
因此,我們在商業和 D 部分的訪問量都在 80% 以上。
Unfortunately, I'm unable to provide forward-looking expectations in terms of pricing.
不幸的是,我無法在定價方面提供前瞻性預期。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Great.
偉大的。
Enrique, thank you.
恩里克,謝謝。
Dave?
戴夫?
David A. Ricks - CEO, President and Director
David A. Ricks - CEO, President and Director
Yes, and just briefly on baricitinib, you're correct in saying that the program had a number of steps up after the initial placebo-controlled phases.
是的,只是簡單地介紹一下巴瑞克替尼,你說得對,在最初的安慰劑對照階段之後,該計劃有許多步驟是正確的。
So maybe patients went from 2 to 4 milligrams or placebo to 4 as rescue.
所以也許患者從 2 到 4 毫克或安慰劑到 4 作為救援。
That's standard in RA studies.
這是 RA 研究的標準。
And we also in the long-term study everyone rolled into, we had a step down feature.
而且我們也在長期研究中每個人都捲入,我們有一個降級功能。
So we have a lot of data about 2 versus 4, and we look forward to talking with the FDA more about that data in the coming days or so.
所以我們有很多關於 2 與 4 的數據,我們期待在未來幾天左右與 FDA 就這些數據進行更多討論。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Thanks, Dave.
謝謝,戴夫。
John, the next caller, please?
約翰,下一個來電者,好嗎?
Operator
Operator
And we actually have no further questions in queue.
我們實際上在隊列中沒有其他問題。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Okay, let me just give a few seconds to see if someone wants to queue.
好的,讓我等幾秒鐘看看是否有人要排隊。
And if not, we'll go to the close.
如果沒有,我們將結束。
So let's give a couple of seconds for that, please.
因此,請讓我們花幾秒鐘的時間。
Did anyone queue, John?
有人排隊嗎,約翰?
Operator
Operator
No further questions coming in.
沒有進一步的問題。
Philip L. Johnson - VP, Investor Relations
Philip L. Johnson - VP, Investor Relations
Thank you very much.
非常感謝。
Dave, why don't you go ahead and close out the call.
戴夫,你為什麼不繼續結束通話。
David A. Ricks - CEO, President and Director
David A. Ricks - CEO, President and Director
Okay.
好的。
Thanks, Phil.
謝謝,菲爾。
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。
As we've discussed before, Lilly is entering a period of growth driven by new product launches.
正如我們之前所討論的,禮來公司正在進入一個由新產品發布推動的增長期。
The diversity of our product portfolio, our top line growth prospect and the opportunity for margin expansions over the balance of the decade provide a compelling thesis for investors.
我們產品組合的多樣性、我們的收入增長前景以及在十年餘下時間裡利潤率擴張的機會為投資者提供了一個引人注目的論點。
I look forward to our continued interactions and keeping you informed of our progress.
我期待著我們繼續互動,並讓您了解我們的進展。
Please follow up with our IR team if you have any questions we didn't address today.
如果您有任何我們今天沒有解決的問題,請與我們的 IR 團隊聯繫。
Thanks again, and have a good day.
再次感謝,祝您有美好的一天。
Operator
Operator
Ladies and gentlemen, that does conclude your conference.
女士們先生們,你們的會議到此結束。
Thank you for your participation.
感謝您的參與。
You may now disconnect.
您現在可以斷開連接。