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Operator
Operator
My name is Skinner, and I'll be your conference facilitator today for Amgen's Second Quarter 2017 Financial Results Conference Call. (Operator Instructions)
我叫史金納,今天我將擔任安進公司 2017 年第二季財務業績電話會議的主持人。(操作說明)
I would now like to introduce Arvind Sood, Vice President of Investor Relations. Mr. Sood, you may now begin.
現在我謹向大家介紹投資人關係副總裁 Arvind Sood。蘇德先生,您可以開始了。
Arvind Sood - VP of IR
Arvind Sood - VP of IR
Thank you, Skinner. Good afternoon, everybody. Thanks for taking the time to participate in our conference call today to review our results for the second quarter. So before we begin, I would like to acknowledge those who are new in their coverage or have changed jobs recently, including Michael Yee, who is now Jefferies; Andrew Peters of Deutsche Bank; and Matt Phipps of William Blair. Each of us look forward to working with you.
謝謝你,史金納。大家下午好。感謝您今天抽空參加我們的電話會議,共同回顧我們第二季的業績。所以在開始之前,我想向最近加入報道團隊或更換工作的記者們表示感謝,包括現在就職於 Jefferies 的 Michael Yee;德意志銀行的 Andrew Peters;以及 William Blair 的 Matt Phipps。我們每個人都期待與您合作。
Okay, so let's go ahead and get started with the business at hand. Consistent with the theme that we discussed at the beginning of the year, we delivered a quarter with strong volume growth -- volume-driven growth of our newer products, which, of course, will be key for our long-term growth strategy. So leading our call today is our Chairman and CEO, Bob Bradway, who will provide a brief strategic update. Followed by our CFO, David Meline, who will review our financial results for the second quarter and our outlook for the remainder of 2017. Our Head of Global Commercial Operations, Tony Hooper, will then discuss our product performance during the quarter. Followed by our Head of R&D, Sean Harper, who will provide a pipeline update. We will be using slides for our presentation today, which have been posted on our website and a link was sent to you separately by e-mail.
好的,那我們開始處理手邊的事情吧。正如我們在年初討論的主題一樣,我們本季實現了強勁的銷售成長——這主要得益於我們新產品的銷售成長,而新產品的銷售成長對於我們的長期成長策略至關重要。今天主持我們電話會議的是董事長兼執行長鮑勃·布拉德韋,他將簡要介紹戰略方面的最新情況。接下來是我們的財務長大衛梅林,他將回顧我們第二季的財務表現以及我們對 2017 年剩餘時間的展望。接下來,我們的全球商業營運主管托尼胡珀將討論我們本季的產品表現。接下來,我們的研發主管肖恩哈珀將介紹產品線的最新進展。我們今天將使用幻燈片進行演示,幻燈片已發佈在我們的網站上,並且我們已透過電子郵件單獨向您發送了連結。
We plan on using non-GAAP financial measures in today's presentation to provide information which may be useful in understanding our ongoing business performance. However, these non-GAAP financial measures should be considered together with GAAP results, and reconciliations of these measures are available in the schedules accompanying today's press release, our Form 8-K and also on the Investor Relations section of our website.
我們計劃在今天的演示中使用非GAAP財務指標,以提供有助於了解我們持續業務表現的資訊。然而,這些非GAAP財務指標應與GAAP結果一併考慮,這些指標的調節表可在今天新聞稿隨附的附表、我們的8-K表格以及我們網站的投資者關係部分中找到。
So just a reminder that some of the statements made during the course of our presentation today are forward-looking statements, and our 2017 10-K and subsequent filings identify factors that could cause our actual results to differ materially.
因此,在此提醒大家,我們今天在演講過程中所作的一些陳述是前瞻性陳述,我們的 2017 年 10-K 表格及後續文件中列出了可能導致我們實際結果與預期結果有重大差異的因素。
So with that, I would like to turn the call over to Bob.
那麼,接下來我將把電話交給鮑伯。
Robert A. Bradway - Chairman and CEO
Robert A. Bradway - Chairman and CEO
Okay. Thank you, Arvind, and let me thank all of you for joining our call. Halfway through the year, we remain on track to achieve our objectives for 2017 as well as our longer-term objectives. Our second quarter financial performance was enabled by strong volume-driven growth for our newer products including: Prolia, KYPROLIS and Repatha, as well as our other more recently launched drugs. This is encouraging as we continue to believe that such volume-driven growth is a key ingredient for long-term success in this industry. Our transformation efforts are enabling us to make significant investments in our pipeline and new product launches, while still delivering near-term operating leverage, and you see that reflected in our 9% operating income growth and our 15% earnings per share growth this quarter. Our margin trends also reflect the success of our ongoing transformation.
好的。謝謝你,Arvind,也謝謝各位參加我們的電話會議。今年已過半,我們仍有望實現 2017 年的目標以及長期目標。第二季財務表現得益於新產品(包括 Prolia、KYPROLIS 和 Repatha)以及其他近期推出的藥物的強勁銷售成長。令人鼓舞的是,我們仍然相信,這種以銷售驅動的成長是該行業長期成功的關鍵因素。我們的轉型努力使我們能夠對產品線和新產品發布進行重大投資,同時還能實現近期營運槓桿效應,這一點在本季度我們9%的營業收入增長和15%的每股收益增長中得到了體現。我們的利潤率趨勢也反映了我們正在進行的轉型取得了成功。
We continue to generate strong cash flows, enabling us to return significant cash to shareholders, including almost $2 billion in the second quarter alone in share repurchases and dividends. Strong cash flows combined with a strong balance sheet give us the strategic flexibility we want to invest in external innovation. We're continually looking at opportunities in our chosen therapeutic categories, yet we remain disciplined in our approach to looking for investments that will enable our shareholders to prosper.
我們持續產生強勁的現金流,使我們能夠向股東返還大量現金,僅第二季就返還了近 20 億美元用於股票回購和分紅。強勁的現金流和穩健的資產負債表賦予我們策略靈活性,使我們能夠投資外部創新。我們一直在尋找我們所選治療領域的投資機會,但我們始終堅持嚴謹的投資策略,力求讓股東獲得豐厚的回報。
Turning to our product highlights. I want to start with our cardiovascular business and Repatha, which we expect to be a significant contributor to our long-term volume-driven growth. Our focus right now is on improving Repatha patient access in the U.S. and around the world. And with our outcomes data in hand, we're making progress. I was pleased to see the swift updates to cholesterol treatment guidelines and recommendations from 4 leading professional societies interested in atherosclerosis and expect more to come. This change in professional opinion is an important precursor for growth in the market. Additionally, our recent discussions with U.S. payers about Repatha and the need to improve the utilization management process has been constructive, again, reflecting the strengths of our data. Finally, we submitted our outcomes data to regulators this quarter and look forward to being able to incorporate them into our label following regulatory review.
接下來介紹我們的產品亮點。我想先談談我們的心血管業務和瑞百安(Repatha),我們預計它將成為我們長期銷售驅動成長的重要貢獻者。我們目前的重點是改善美國及世界各地患者取得瑞百安(Repatha)藥物的途徑。有了這些結果數據,我們正在取得進展。我很高興看到 4 個關注動脈粥狀硬化的領先專業協會迅速更新了膽固醇治療指南和建議,並期待未來會有更多更新。專業人士意見的這種轉變是市場成長的重要先兆。此外,我們最近與美國支付方就 Repatha 以及改善利用管理流程的必要性進行的討論也富有建設性,再次體現了我們數據的優勢。最後,我們已在本季向監管機構提交了結果數據,並期待在經過監管審查後將其納入我們的標籤中。
Within oncology, I want to highlight a few recent notable milestones. First, in multiple myeloma, we completed 2 pivotal studies showing an overall survival benefit for KYPROLIS patients with relapsed disease, underscoring our confidence in this molecule as the new standard of care for these patients. And similarly, in relapsed and refractory acute lymphoblastic leukemia, BLINCYTO demonstrated an overall survival benefit versus standard of care chemotherapy. I would remind you that BLINCYTO is the first and only bispecific T-cell engager to have done that. Overall survival is the gold standard when it comes to oncology drug development, and we were encouraged to be able to show that patients live longer when treated with KYPROLIS and BLINCYTO.
在腫瘤學領域,我想重點介紹一些近期值得關注的里程碑事件。首先,在多發性骨髓瘤方面,我們完成了 2 項關鍵研究,結果顯示 KYPROLIS 可使復發性疾病患者獲得總生存期獲益,這凸顯了我們對該分子作為這些患者新標準療法的信心。同樣,在復發和難治性急性淋巴細胞白血病中,BLINCYTO 顯示出比標準治療化療更能提高總存活率。我想提醒您,BLINCYTO 是第一個也是唯一一個實現這一目標的雙特異性 T 細胞銜接器。整體存活期是腫瘤藥物研發的黃金標準,我們很欣慰地證明,接受 KYPROLIS 和 BLINCYTO 治療的患者存活期更長。
In neuroscience, we're getting closer to being able to make a meaningful impact in the lives of migraine patients. We submitted erenumab, for which we have the brand name, Aimovig, to U.S. regulators in the second quarter. We have the lead position in this exciting new class of medicines, combining our commercial strengths in specialty biologics with Novartis' established infrastructure in neuroscience, we think, positions us to win in this segment.
在神經科學領域,我們正逐步接近能夠對偏頭痛患者的生活產生有意義的影響。我們在第二季向美國監管機構提交了erenumab(商品名為Aimovig)。我們在這一令人興奮的新藥物類別中處於領先地位,將我們在專業生物製劑方面的商業優勢與諾華在神經科學領域成熟的基礎設施相結合,我們認為,這使我們能夠在這個領域取得成功。
Our biosimilars programs continue to advance nicely and the quality of our work here was on display once again in the recent FDA panel review of our biosimilar to Avastin.
我們的生物相似藥計畫繼續穩步推進,我們在這方面的工作品質在 FDA 專家小組最近對我們阿瓦斯汀生物相似藥的審查中再次得到體現。
The outlook for the company remains strong with growth from newer products and effective life-cycle management of our legacy products, we're confident in our position and looking forward to the second half of the year.
公司前景依然強勁,得益於新產品的成長和對傳統產品的有效生命週期管理,我們對自身地位充滿信心,並期待下半年的發展。
Let me now turn to David to review the financial performance of business.
現在請大衛來回顧一下公司的財務表現。
David W. Meline - CFO and EVP
David W. Meline - CFO and EVP
Okay. Thanks, Bob. We're very pleased with our consistent revenue and earnings growth in the second quarter as our transformation efforts continue to enable investment in our core business, while also delivering operating leverage in the period of portfolio transition and the competitive environment.
好的。謝謝你,鮑伯。我們對第二季持續的收入和獲利成長感到非常滿意,因為我們的轉型努力繼續為核心業務的投資提供支持,同時在投資組合過渡期和競爭環境中實現了營運槓桿效應。
Turning to the financial results on Page 6 of the slide deck. Worldwide revenues at $5.8 billion in the second quarter grew 2% year-over-year. This quarter, we also saw our products sales at $5.6 billion, growing 2% year-over-year as well, as strong unit growth demand for our newer products outweighed declines in the mature brands. We're particularly encouraged by our 11% year-over-year volume growth in Europe, reflecting the value of our innovative products in a market where we have experienced biosimilar competition and portfolio transition for a number of years.
接下來請看投影片第6頁的財務表現。第二季全球營收達 58 億美元,年增 2%。本季度,我們的產品銷售額也達到 56 億美元,年增 2%,這主要得益於新產品強勁的銷售成長,抵銷了成熟品牌銷售的下滑。我們尤其對歐洲市場年增 11% 的銷售成長感到鼓舞,這反映了我們創新產品的價值。多年來,我們在這個市場經歷了生物相似藥的競爭和產品組合的轉型。
Other revenues at $236 million grew 10% versus the second quarter of 2016, driven by higher Ibrance royalty revenue, offset partially by decreased Nexavar royalty revenue. Changes in foreign exchange had a 1% negative impact to total revenue and product sales in the quarter on a year-over-year basis.
其他收入為 2.36 億美元,比 2016 年第二季度增長 10%,主要得益於 Ibrance 特許權使用費收入的增加,但部分被 Nexavar 特許權使用費收入的減少所抵消。外匯變動對本季總收入和產品銷售額造成了同比 1% 的負面影響。
Non-GAAP operating income at $3.1 billion grew 9% from the prior year. Non-GAAP operating margin improved 3.8 points to 55.2% for the quarter, reflecting positive revenue performance, continued favorable expense impacts from our transformation initiatives across all operating expense categories and the expiry of the Enbrel residual royalty payment in Q4 of 2016.
非GAAP營業收入為31億美元,較上年成長9%。本季非GAAP營業利潤率提高3.8個百分點至55.2%,反映出積極的營收表現、我們轉型計畫在所有營運費用類別中持續帶來的有利費用影響,以及Enbrel剩餘特許權使用費在2016年第四季到期。
On a full year basis, we expect another year of strong operating margins, driven by tight operational expense management. We expect to see our typical trend of higher operating expenses during the second half of the year.
從全年來看,我們預計在嚴格的營運費用控制下,將繼續保持強勁的營運利潤率。我們預計下半年營運費用將延續以往的成長趨勢。
On a non-GAAP basis, cost of sales as a percent of product sales improved by 0.8 points to 12.7%, driven by reduced royalties. Research and development expenses at $851 million were down 3% year-over-year, driven by lower spending required to support certain later-stage clinical programs and continued benefits from our transformation initiatives and process improvement efforts.
以非GAAP準則計算,銷售成本佔產品銷售額的百分比下降了0.8個百分點,達到12.7%,這主要得益於特許權使用費的減少。研發費用為 8.51 億美元,年減 3%,主要原因是支持某些後期臨床項目所需的支出減少,以及我們轉型計畫和流程改善工作帶來的持續效益。
R&D as a percent of sales was 15.3% in the second quarter. We expect research and development as a percent of product sales to approach 2016 levels in the second half of the year. SG&A expenses decreased 7% on a year-over-year basis, due to the expiry of the Enbrel residual royalty payment, partially offset by increased investments in product launches. In aggregate, non-GAAP operating expenses decreased 5% year-over-year and remain on track to meet or exceed our 2018 commitment of $1.5 billion in transformation savings while investing to build the business globally, support new product launches and investing in the long-term pipeline for the business. Other income and expenses were a net $156 million expense in Q2. This is favorable by $20 million on a year-over-year basis, primarily driven by higher cash balances.
第二季研發支出佔銷售額的15.3%。我們預計下半年研發支出佔產品銷售額的比例將接近 2016 年的水準。由於 Enbrel 剩餘特許權使用費到期,銷售、一般及行政費用年減 7%,但部分被產品上市投資增加所抵銷。總體而言,非GAAP營運費用年減5%,並有望實現或超過我們2018年15億美元的轉型節約承諾,同時投資於在全球範圍內發展業務、支持新產品發布以及投資於業務的長期發展規劃。第二季其他收入和支出淨額為 1.56 億美元。與去年同期相比,這帶來了 2,000 萬美元的收益,主要得益於現金餘額的增加。
The non-GAAP tax rate was 17.4% for the quarter, a 1.2 point decrease versus the second quarter of 2016. This decrease reflects discrete benefits associated with the settlement of certain state and federal tax matters and favorable changes in the geographic mix of earnings, offset partially by a prior year benefit associated with tax incentives.
本季非GAAP稅率為17.4%,比2016年第二季下降了1.2個百分點。這一下降反映了與解決某些州和聯邦稅務事項相關的離散收益以及收入地域構成有利的變化,但部分被上一年與稅收優惠相關的收益所抵消。
Non-GAAP net income increased 12% and non-GAAP earnings per share increased 15% year-over-year for the second quarter to $3.27 per share.
第二季非GAAP淨利年增12%,非GAAP每股盈餘較去年同期成長15%,達到每股3.27美元。
Turning next to cash flow and the balance sheet on Page 7. Free cash flow was $2.1 billion for the quarter compared to free cash flow of $2.5 billion in the second quarter of 2016, driven by timing impacts of income tax payments to the IRS. We continue to provide significant cash returns to shareholders, consistent with our commitments as we deployed $1 billion to repurchase 6.2 million shares at an average of $162 per share, and are on track to achieve total share repurchase for this year in the range of $2.5 billion to $3.5 billion, as previously communicated.
接下來,請看第 7 頁的現金流量和資產負債表。本季自由現金流為 21 億美元,而 2016 年第二季自由現金流為 25 億美元,主要是由於向美國國稅局繳納所得稅的時間影響所致。我們繼續向股東提供可觀的現金回報,這與我們先前的承諾一致。我們已投入 10 億美元以平均每股 162 美元的價格回購了 620 萬股股票,正如之前所宣布的那樣,我們預計將實現今年 25 億美元至 35 億美元的股票回購總額。
Additionally, our second quarter dividend of $1.15 per share is an increase of 15% over last year. This reflects our balanced approach to capital allocation. With significant investment in innovation in support of long-term growth of the business as well as return of cash to shareholders.
此外,我們第二季每股股利 1.15 美元,比去年同期成長 15%。這體現了我們均衡的資本配置方法。公司對創新進行了大量投資,以支持業務的長期成長,並向股東返還現金。
We continue to maintain financial and strategic flexibility as a result of our strengthening balance sheet position. Cash and investments totaled $39.2 billion, an increase of $4.2 billion from the second quarter of last year. This increase reflects continued solid net cash flow generation.
由於資產負債表狀況不斷改善,我們得以繼續保持財務和策略上的靈活性。現金及投資總額為 392 億美元,比去年第二季增加了 42 億美元。這一增長反映了淨現金流的持續穩健成長。
Our debt balance stands at $35.1 billion as of June 30, carrying a weighted average interest rate of 3.7% and an average maturity of 13 years.
截至6月30日,我們的債務餘額為351億美元,加權平均利率為3.7%,平均年期為13年。
Turning to the outlook for the business for 2017 on Page 8. Overall, our revised 2017 revenue guidance is $22.5 billion to $23 billion. Our first half 2017 volume and price performance was in line with our plans as we experienced a solid contribution from our newer products while managing the impact of competition against the balance of the portfolio.
接下來請看第 8 頁對 2017 年業務前景的展望。整體而言,我們修訂後的 2017 年營收預期為 225 億美元至 230 億美元。2017 年上半年,我們的銷售量和價格表現符合預期,這得益於新產品的穩健貢獻,同時我們也有效應對了競爭對產品組合其他部分的影響。
This range also reflects the potential impact during the remainder of 2017 from the outcome of Repatha litigation, and potential for improved access for appropriate patients as a result of the positive Repatha outcomes data and professional society guidelines and recommendation updates.
這個範圍也反映了 Repatha 訴訟結果在 2017 年剩餘時間內可能產生的影響,以及由於 Repatha 積極的療效數據和專業協會指南及建議的更新,合適的患者獲得治療的機會可能會得到改善。
Our guidance assumes no new U.S. biosimilar competition in 2017. With regard to our non-GAAP earnings per share guidance, we are raising and narrowing the outlook to $12.15 to $12.65 per share, reflecting our overall solid first half 2017 performance and continued operational expense management. Further, we are confirming our non-GAAP tax guidance at 18.5% to 19.5%. We continue to expect capital expenditures of approximately $700 million this year. Finally, consistent with our 2017 outlook, we remain confident that we will meet or exceed the commitments we provided for the 2014 to '18 period, including double-digit non-GAAP EPS growth, non-GAAP operating margin improvement from 38% to 52% to 54%, $1.5 billion of transformation savings; and return to shareholders of at least 60% of non-GAAP net income on average during the period.
我們的指導意見假設 2017 年美國不會出現新的生物相似藥競爭。關於我們的非GAAP每股收益預期,我們將預期上調並縮小至每股12.15美元至12.65美元,這反映了我們2017年上半年整體穩健的業績和持續的營運費用控制。此外,我們確認非GAAP稅務指導為18.5%至19.5%。我們預計今年的資本支出仍約為7億美元。最後,與我們對 2017 年的展望一致,我們仍然有信心實現或超過我們對 2014 年至 2018 年期間所作出的承諾,包括兩位數的非 GAAP 每股收益增長、非 GAAP 營業利潤率從 38% 提高到 52% 再提高到 54%、非 GAAP 營業利潤率從 38% 提高到 52% 再提高到 54%、非 GAAP 營業利率在 38% 以及 52% 上再提高到 54% 的收入至少 60% 以及 AAP% 以及此收入在淨收入期間還為 20% 的收入至少 60%
This concludes the financial update. I now turn the call over to Tony.
財務更新到此結束。現在我把電話交給東尼。
Anthony C. Hooper - EVP of Global Commercial Operations
Anthony C. Hooper - EVP of Global Commercial Operations
Thank you, David. And you'll find the sales detail starting on Slide #10. We delivered a strong solid quarter with sales increasing 2% year-over-year. Prolia, and our more recently launched brands including Repatha and KYPROLIS, continue to deliver strong volume growth. We are focused on a near-term growth and realizing their long-term potential as the product portfolio continues to transition.
謝謝你,大衛。銷售詳情從第 10 張投影片開始。本季業績穩健,銷售額年增 2%。Prolia 以及我們最近推出的品牌,包括 Repatha 和 KYPROLIS,持續保持強勁的銷售成長。我們專注於近期成長,並隨著產品組合的不斷轉型,實現其長期潛力。
For the quarter, sales in the U.S. increased 2% year-over-year, while sales outside the U.S. increased 8%, excluding the impact of foreign exchange, or 3% including. Internationally, we had double-digit volume growth, led by our European business.
本季度,美國銷售額年增 2%,美國以外地區的銷售額年增 8%(不計匯率影響),或年增 3%(計入匯率影響)。在國際市場,我們的銷售量實現了兩位數的成長,其中歐洲業務表現尤為突出。
Let me begin first with Prolia. Prolia sales increased 15%, with an 18% volume growth year-over-year, from share gains and in both the U.S. and our international markets. Prolia continues to offer a unique opportunity to both postmenopausal osteoporosis patients as well as Amgen. There are currently about 3.5 million patients on Amgen -- on Prolia globally, roughly equally distributed across the regions. About 1 million in the U.S., about 1.6 million in Europe and the rest of the world about 1 million. Elderly patients who suffer bone fractures often become bedridden and face potential loss of their independence. This places an enormous economic burden on society, and less than half of diagnosed patients aren't treated, raising the need for improved education and treatment guidelines. This is what we, as a company, are focusing on next.
首先讓我從Prolia開始。Prolia 的銷售額成長了 15%,銷量年增了 18%,這得益於市場份額的提升,並且在美國和國際市場上均取得了增長。Prolia 繼續為停經後骨質疏鬆症患者和安進公司提供獨特的機會。目前全球約有 350 萬名患者正在接受安進公司的 Prolia 治療,大致均勻分佈在各個地區。美國約有100萬人,歐洲約有160萬人,世界其他地區約有100萬人。老年患者在骨折後往往臥床不起,面臨喪失自理能力的風險。這給社會帶來了巨大的經濟負擔,而且不到一半的確診患者沒有接受治療,這就凸顯了改善教育和治療指南的必要性。這是我們公司接下來重點關注的方向。
Prolia's average share of treated patients is around 20%, both in the U.S. and globally. However, there are some countries such as Australia, Switzerland and Ireland, with better diagnosis and treatment rates for osteoporosis, have led to Prolia having 50% share or better. These are countries who truly understand the societal cost of nonintervention.
無論是在美國還是在全球範圍內,Prolia 治療的患者平均佔比約為 20%。然而,在澳洲、瑞士和愛爾蘭等一些國家,骨質疏鬆症的診斷和治療率較高,使得 Prolia 獲得了 50% 或更高的市場份額。這些國家真正了解不干預的社會代價。
Prolia has a strong clinical profile with a proven ability to reduce risk of fractures, combined with solid long-term safety data spanning over 10 years and a convenient twice per year administration schedule. Prolia will remain an important growth driver and we'll continue to target our commercial efforts on improving diagnosis, treatment rates and duration in order to drive access to a greater number of these patients.
Prolia 具有強大的臨床療效,已被證實能夠降低骨折風險,並擁有超過 10 年的可靠長期安全性數據,且每年只需服用兩次,非常方便。Prolia 仍將是重要的成長動力,我們將繼續致力於提高診斷率、治療率和治療持續時間,以便讓更多患者能夠獲得治療。
KYPROLIS grew 23% year-over-year, led by our successful launch efforts across existing and new markets outside the United States. Uptake continues to be robust across these launch markets with a 20% sequential volume growth. As Bob mentioned, KYPROLIS has developed 2 sets of exciting overall survival data in relapsed multiple myeloma patients this year. Early in the year, in the head-to-head ENDEAVOR study against Velcade, we demonstrated that the KYPROLIS on, reduced the risk of death by 21%, and improved overall survival by about 8 months compared to the Velcade arm.
KYPROLIS 年成長 23%,這主要得益於我們在美國以外的現有市場和新市場的成功推出。在這些首發市場,市場接受度持續強勁,銷售量較上季成長 20%。正如鮑伯所提到的,KYPROLIS 今年在復發性多發性骨髓瘤患者中獲得了 2 組令人振奮的總存活期數據。今年年初,在與 Velcade 進行的 ENDEAVOR 頭對頭研究中,我們證明,與 Velcade 組相比,KYPROLIS 可降低 21% 的死亡風險,並提高約 8 個月的總存活期。
Just recently, the ASPIRE study demonstrated that adding KYPROLIS to Revlimid and dexamethasone also reduced the risk of death by 21%, and improved survival by about 8 months. It is clear, multiple myeloma patients live longer when treated with KYPROLIS. With these 2 new sets of overall survival data, our message to physicians is simple and powerful: when multiple myeloma relapses, don't put your patient survival at risk, KYPROLIS-based regimens, KRd and Kd reduce the risk of death by 21% versus Rd and Vd, and extended overall survival by 7.9 and 7.6 months, respectively. This data will also help community oncologists better understand the risk-benefit ratio -- profile of KYPROLIS versus other options.
就在不久前,ASPIRE 研究表明,在瑞復美和地塞米鬆的基礎上添加 KYPROLIS 還可以降低 21% 的死亡風險,並延長約 8 個月的生存期。很明顯,接受 KYPROLIS 治療的多發性骨髓瘤患者壽命更長。有了這兩組新的總生存期數據,我們向醫生傳達的信息簡單而有力:當多發性骨髓瘤復發時,不要讓患者的生存受到威脅,基於 KYPROLIS 的方案 KRd 和 Kd 與 Rd 和 Vd 相比,可將死亡風險降低 21%,並將總生存期分別延長 7.9 個月和 7.6 個月。這些數據也將幫助社區腫瘤學家更了解 KYPROLIS 與其他方案相比的風險效益比。
XGEVA grew 4% year-over-year, mostly due to volume. We look forward to having the positive multiple myeloma study data added to our label in 2018, which will expand the eligible patient population and provide a new growth opportunity for XGEVA.
XGEVA較去年同期成長4%,主要得益於銷售成長。我們期待在 2018 年將積極的多發性骨髓瘤研究數據添加到我們的標籤中,這將擴大符合條件的患者群體,並為 XGEVA 提供新的成長機會。
For Nplate and Vectibix, we continue to see strong volume growth in both brands. Vectibix has now over 50% share of the U.S. EGFR segment. Our recent label update, which includes expanded RAS testing, demonstrates Amgen's ongoing commitment to using cutting edge science and technology to target treatments to patients most likely to benefit.
Nplate 和 Vectibix 這兩個品牌的銷售量均持續強勁成長。Vectibix目前在美國EGFR市場佔有超過50%的市佔率。我們最近更新的標籤,包括擴大 RAS 檢測範圍,顯示安進公司持續致力於運用尖端科學技術,為最有可能受益的患者提供治療。
Turning now to Neulasta. We continue to drive adoption of Neulasta Onpro, exiting the second quarter with about 55% share of Neulasta sales. The treatment and convenience benefits to patients and providers is clear. The penetration continues to improve in patients undergoing minor suppressive chemotherapy regimens. I'll point out, however, as we look at the cancer therapy in total, PD-1s and other new novel therapies are causing a low single-digit decline in the usage of myelosuppressive agents. We've also seen a small share loss internationally. We believe these factors contributed to the year-over-year decline of about 5%.
現在轉向紐拉斯塔。我們持續推動 Neulasta Onpro 的普及,第二季末,Neulasta 的銷售額佔比約為 55%。治療效果和便利性對患者和醫療服務提供者來說顯而易見。接受輕微抑制性化療方案的患者,藥物滲透性持續改善。不過,我要指出的是,從整體來看癌症治療,PD-1 和其他新型療法正在導致骨髓抑制劑的使用量出現個位數的下降。我們在國際市場上也出現了小幅市佔率下滑。我們認為這些因素導致了年減約 5%。
The quarter-over-quarter decline of 10% was primarily due to heavier purchasing by certain end customers and favorable accounting adjustments in the first quarter. We expect the trends in myelosuppressive regimens to continue for the remainder of the year. I'd point out, however, that in spite of decreased use of myelosuppressive regimens, there has been an increase in a number of hospital admissions for febrile neutropenia, and we continue to focus on improving penetration for the benefit of patients and for the reduction of unnecessary hospitalization costs.
環比下降 10% 主要是由於某些終端客戶加大採購量以及第一季有利的會計調整。我們預計骨髓抑制療法的趨勢將在今年剩餘的時間持續下去。不過,我想指出的是,儘管骨髓抑制療法的使用有所減少,但發燒性中性粒細胞減少症的住院人數卻有所增加,我們將繼續致力於提高療法的普及率,以造福患者並減少不必要的住院費用。
Looking forward, I'd remind you that the fourth quarter of 2016 also included a single $38 million purchase from the U.S. government.
展望未來,我想提醒各位,2016 年第四季還包括一筆來自美國政府的 3,800 萬美元的採購。
NEUPOGEN declined 30% year-over-year. The impact of short-acting biosimilar competition on NEUPOGEN in the U.S. was in line with prior trends. We exited the second quarter holding 44% share of the short-acting segment, and importantly, have maintained pricing discipline of the 3-plus years since NEUPOGEN first faced competition in the U.S. We expect the competitive dynamic to continue through the rest of 2017.
NEUPOGEN年減30%。短效生物相似藥競爭對美國紐寶健的影響與先前的趨勢一致。第二季末,我們在短效藥市場佔有 44% 的份額,更重要的是,自 NEUPOGEN 首次在美國面臨競爭以來,我們一直保持著三年多的定價紀律。我們預計這種競爭態勢將在 2017 年剩餘時間持續下去。
Enbrel sales declined 1% year-over-year but increased 24% on a quarter-over-quarter basis. In the first quarter, you'll recall that market volume growth rates in both rheumatology and dermatology segments have contracted from recent levels. As expected, in the second quarter, market volume growth improved in both segments. We expect year-over-year segment growth trends to approximate these recent levels for the balance of the year. Sequentially, our unit share was relatively stable in both rheumatology and dermatology, declining less than 1 percentage point to 31% in rheumatology and 15% in dermatology.
Enbrel 的銷售額年減 1%,但較上季成長 24%。大家應該還記得,第一季風濕病學和皮膚病學領域的市場銷售成長率都比近期水準下降。如預期,第二季兩個細分市場的銷售成長均有所改善。我們預計今年剩餘時間內,各細分市場的年成長趨勢將與近期的水平大致持平。從順序上看,我們在風濕病學和皮膚病學領域的市場份額相對穩定,風濕病學領域的市場份額下降不到 1 個百分點,至 31%,皮膚病學領域的市場份額下降不到 15%。
Changes in net selling price had a positive impact on Enbrel sequential growth. Recall that quarter 1 was negatively impacted by increased commercial copay assistance. As calculated on a full year basis, we continue to expect the year-over-year impact of changes in net selling price to be negligible.
淨售價的變化對恩利(Enbrel)的環比增長產生了積極影響。回想一下,第一季受到了商業共同支付援助增加的負面影響。以全年計算,我們仍預期淨售價變動對年比業績的影響可忽略不計。
We estimate that we exited the second quarter with a balance of about $140 million of excess end-user inventory. We expect the portion of this excess inventory to deplete through the remainder of the year.
我們估計,截至第二季末,我們的終端用戶庫存過剩餘額約為 1.4 億美元。我們預計這部分過剩庫存將在今年剩餘時間內消耗完畢。
In summary, we saw improvement in the underlying segment performance this quarter versus the prior quarter and our share trajectory continues as previously projected. Enbrel has a strong track record of safety and efficacy in treating patients with rheumatoid arthritis and psoriasis. We continue to believe the long-term dynamics are intact and continue to invest in Enbrel to remain competitive in these growing segments.
總而言之,本季我們基礎業務部門的表現較上一季有所改善,我們的市佔率成長軌跡也持續按照先前的預測發展。Enbrel 在治療類風濕性關節炎和乾癬患者方面具有良好的安全性和有效性記錄。我們仍然相信長期發展趨勢仍然穩固,並將繼續投資恩利,以在這些不斷增長的領域中保持競爭力。
Aranesp grew 6% year-over-year, primarily from volume growth, which includes the benefit from some timing of tenders in certain markets outside the U.S. versus the prior year.
Aranesp 年成長 6%,主要得益於銷售成長,其中包括美國以外某些市場招標時間較上年有所調整所帶來的收益。
With EPOGEN, we've been executing our life-cycle management strategy by successfully transitioning much of the dialysis business to Aranesp and extending our supply contract with DaVita through 2022. The transition to Aranesp is largely complete. In the second quarter, year-over-year decline in EPOGEN is primarily due to lower net prices as a result of the DaVita agreement. We believe that, for now, our EPOGEN volume has stabilized.
透過與 EPOGEN 的合作,我們成功地將大部分透析業務轉移到 Aranesp,並將與 DaVita 的供應合約延長至 2022 年,從而執行了我們的生命週期管理策略。向 Aranesp 的過渡已基本完成。第二季 EPOGEN 年減主要是因為與 DaVita 達成協議導致淨價降低。我們認為,就目前而言,我們的 EPOGEN 銷售量已經穩定下來。
Sensipar year-over-year growth of 10% was mainly due to net selling price, and to a lesser extent, unit growth. We continue to await CMS guidance on the reimbursement mechanism for Parsabiv. Parsabiv launches are underway in Europe with 7 markets so far and 3 more expected by year-end.
Sensipar 年成長 10%,主要歸功於淨售價的成長,其次是銷售成長。我們仍在等待 CMS 對 Parsabiv 報銷機制的指導意見。Parsabiv 正在歐洲進行推廣,目前已進入 7 個市場,預計到年底還將進入 3 個市場。
In conclusion, let me turn to Repatha. We continue to extend our market leadership across the U.S. and Europe. We now hold 58% share of the PCSK9 segments in both markets, with sequential growth points of 4 points in the U.S. and 2 points in Europe.
最後,讓我來談談瑞百莎(Repatha)。我們繼續擴大在美國和歐洲的市場領先地位。目前,我們在兩個市場的 PCSK9 細分市場中均佔有 58% 的份額,其中美國市場連續成長 4 個百分點,歐洲市場連續成長 2 個百分點。
More importantly, in the U.S., new to brand patient share averaged 70% in the second quarter. Since March, and the presentation of the positive Repatha outcomes data, we've been engaging with payers to improve the utilization management criteria and processes to improve access for appropriate patients.
更重要的是,在美國,第二季新品牌患者佔比平均達到 70%。自 3 月公佈 Repatha 的積極療效數據以來,我們一直在與支付方合作,改進利用管理標準和流程,以改善適當患者的用藥機會。
Payers and PBMs acknowledge the benefit to patients demonstrated by the outcomes data and are evaluating changes to their processes. We continue to believe that Repatha will grow steadily as guidelines and clinical pathways are revised and the outcome data are in our label. We look forward to the publication of the final update of ACC Expert Consensus Decision Pathway, an important reference for physicians.
支付方和藥品福利管理機構認可結果數據所顯示的對患者的好處,並正在評估對其流程的改進。我們仍然相信,隨著指南和臨床路徑的修訂以及結果數據納入我們的標籤,Repatha 將穩步成長。我們期待 ACC 專家共識決策路徑最終更新版的發布,這對醫生來說是重要的參考資料。
Cardiovascular disease continues to be the #1 cause of death and disability in the world. Repatha has the potential to help millions of patients around the world dealing with this grievous illness.
心血管疾病仍然是全球首要的死亡和殘疾原因。Repatha 有潛力幫助全世界數百萬正在與這種嚴重疾病奮戰的患者。
Let me close by thanking all the Amgen staff who worked so hard and tirelessly to get important products to patients around the world.
最後,我要感謝安進公司所有員工,他們辛勤工作、不懈努力,為世界各地的患者提供重要的產品。
I'll now pass you to Dr. Sean Harper. Sean?
現在我將把麥克風交給肖恩哈珀博士。肖恩?
Sean E. Harper - EVP of Research and Development
Sean E. Harper - EVP of Research and Development
Thanks, Tony, and good afternoon. I'll begin my comments today with an update on our cardiovascular efforts. In Q2, we submitted our Repatha outcomes data to global regulators, and we look forward to working with them to include this important update to the prescribing information. I have also been very encouraged to see multiple professional societies updating their expert consensus documents and guidelines on the use of PCSK9 inhibitors, including the U.S. National Lipid Association, the American Association of Clinical Endocrinologists and the European Society of Cardiology and European Atherosclerosis Society, clearly reflecting the importance of our Repatha outcomes data.
謝謝你,托尼,下午好。今天我首先要報告我們在心血管方面的工作進展。第二季度,我們向全球監管機構提交了 Repatha 的結果數據,我們期待與他們合作,將這項重要更新納入處方資訊中。我也非常欣慰地看到,包括美國國家脂質協會、美國臨床內分泌醫師協會、歐洲心臟病學會和歐洲動脈粥樣硬化學會在內的多個專業協會正在更新其關於使用 PCSK9 抑製劑的專家共識文件和指南,這清楚地反映了我們 Repatha 結果數據的重要性。
In addition, a draft version of the 2017 update of the ACC Expert Consensus Decision Pathway on nonstatin therapies for LDL cholesterol lowering has recently been made available for public comment. These decision pathways are intended, among other things, to provide guidance to clinicians in areas where clinical evidence is new and evolving. While the document is still in draft form, we find the concepts within to well reflect the excellent safety profile and efficacy of Repatha, and to suggest evidence-based utilization in appropriate patient populations. We expect the final publication of this document in Q3 of this year.
此外,ACC 專家共識決策路徑關於非他汀類藥物降低 LDL 膽固醇的 2017 年更新草案已於近期發布,供公眾審查。這些決策路徑的目的之一是為臨床醫生提供指導,尤其是在臨床證據尚不完善且不斷發展的領域。雖然該文件仍處於草稿階段,但我們發現其中的概念很好地反映了瑞百安(Repatha)優異的安全性和有效性,並建議在適當的患者群體中基於證據使用該藥物。我們預計文件將於今年第三季最終發布。
Beyond Repatha, we've advanced our ASGR1 inhibitor into the clinic in the form of an antibody. As it is just over a year since we first published the strong genetic association of ASGR1 variants with cardiovascular disease in the New England Journal of Medicine, our rapid movement into the clinic demonstrates the speed at which we're able to move programs forward when we have human validation of the sort that deCODE Genetics can provide, to ultimately improve R&D productivity.
除了 Repatha 之外,我們還將 ASGR1 抑制劑以抗體的形式推進到臨床階段。自從我們在《新英格蘭醫學雜誌》上首次發表 ASGR1 變異與心血管疾病的強遺傳關聯以來,僅僅一年多一點的時間,我們迅速進入臨床階段,這表明,當我們擁有像 deCODE Genetics 能夠提供的這種人體驗證時,我們能夠以多快的速度推進項目,最終提高研發效率。
We also have additional modalities directed against this target under preclinical investigation. Our omecativ mecarbil Phase III outcome study in heart failure continues to enroll briskly, demonstrating the interest in an innovative new add-on therapy in an area in which significant unmet need still exists. And finally, we're looking forward to the presentation of the anacetrapib REVEAL study by Merck to help inform our plans for our own CTEP inhibitor AMG 899.
我們還有其他針對該標靶的療法正在進行臨床前研究。我們針對心臟衰竭的 omecativ mecarbil III 期結果研究仍在快速招募患者,這表明人們對這種創新的附加療法很感興趣,因為該領域仍然存在巨大的未滿足需求。最後,我們期待默克公司公佈 anacetrapib REVEAL 研究結果,以幫助我們制定自己的 CTEP 抑制劑 AMG 899 的計劃。
Turning to oncology. We recently received our second positive overall survival result with KYPROLIS, this time from the ASPIRE study. We clearly demonstrated KYPROLIS' superiority to Velcade with improved overall survival in the ENDEAVOR study of KYPROLIS plus dexamethasone versus Velcade plus dexamethasone. And now we've demonstrated positive survival benefit from KYPROLIS plus Revlimid plus dexamethasone versus Revlimid plus dexamethasone in the ASPIRE study. In each case, KYPROLIS reduced the risk of death by 21% and improved survival by approximately 8 months, a very meaningful clinical result that reinforces the role for KYPROLIS in driving deep and durable responses.
轉向腫瘤學。我們最近收到了 KYPROLIS 治療整體存活率的第二個正面結果,這次來自 ASPIRE 研究。在 ENDEAVOR 研究中,KYPROLIS 聯合地塞米松與 Velcade 聯合地塞米松相比,KYPROLIS 顯著提高了總生存期,證明了 KYPROLIS 優於 Velcade。現在,我們在 ASPIRE 研究中已經證明,KYPROLIS 加 Revlimid 加地塞米鬆比 Revlimid 加地塞米松具有積極的生存獲益。在每個案例中,KYPROLIS 將死亡風險降低了 21%,存活期延長了約 8 個月,這是一個非常有意義的臨床結果,強化了 KYPROLIS 在驅動深度和持久反應中的作用。
We have already submitted the ENDEAVOR overall survival data to regulators for inclusion in the labels, and we're preparing the ASPIRE data for submission as well. And lastly, on KYPROLIS, our Phase III study in combination with Darzalex in relapsed or refractory multiple myeloma began enrolling patients in the second quarter. At ASCO, we had the opportunity to present Phase II data for our -- from our combination study of IMLYGIC and YERVOY in metastatic melanoma, where we saw an approximate doubling of the response rate compared to YERVOY alone with no unexpected toxicities. This was an important proof of concept for combining the complementary mechanisms of an oncolytic viral immunotherapy and a checkpoint inhibitor to enhance antitumor effects. There is significant interest in exploring IMLYGIC with other checkpoint inhibitors in a variety of tumor types.
我們已經將 ENDEAVOR 的整體生存數據提交給監管機構,以便將其納入藥品標籤,我們也正在準備 ASPIRE 的數據以供提交。最後,關於 KYPROLIS,我們針對復發或難治性多發性骨髓瘤患者進行的 III 期研究(與 Darzalex 合併用藥)已於第二季開始招募患者。在 ASCO 會議上,我們有機會展示了 IMLYGIC 和 YERVOY 聯合治療轉移性黑色素瘤的 II 期研究數據,結果顯示,與單獨使用 YERVOY 相比,聯合用藥使緩解率提高了約一倍,且沒有意外的毒性反應。這是將溶瘤病毒免疫療法和檢查點抑制劑的互補機制結合起來以增強抗腫瘤效果的重要概念驗證。人們對探索 IMLYGIC 與其他檢查點抑制劑聯合用於多種腫瘤類型表現出濃厚的興趣。
In regulatory news, we received a February 2018 PDUFA date for our XGEVA submission for the prevention of skeletal-related events in multiple myeloma patients. We also received full approval for BLINCYTO in the U.S. The approval expands the indication of BLINCYTO for the treatment of relapsed or refractory ALL in adults and now children, and included overall survival data and an indication for Philadelphia chromosome-positive forms of the disease.
在監管新聞方面,我們收到了 2018 年 2 月的 PDUFA 日期,用於提交我們的 XGEVA 申請,該申請旨在預防多發性骨髓瘤患者的骨骼相關事件。我們也獲得了美國對 BLINCYTO 的全面批准。這項批准擴大了 BLINCYTO 的適應症,使其可用於治療成人和兒童的複發性或難治性 ALL,並納入了總生存期數據以及對費城染色體陽性疾病的適應症。
Also, within our BiTE platform, we're advancing AMG 673, our half-life extended anti-CD33 BiTE into the clinic, the first in-human testing in AML patients to begin soon. And lastly, we received a label update for Vectibix to more precisely molecularly define the population with wild-type RAS for treatment in colorectal cancer.
此外,在我們的 BiTE 平台中,我們正在推進半衰期延長的抗 CD33 BiTE 藥物 AMG 673 進入臨床階段,即將開始對 AML 患者進行首次人體試驗。最後,我們收到了 Vectibix 的標籤更新,以便更精確地從分子層面定義 RAS 野生型族群,用於治療大腸直腸癌。
In our bone health therapeutic area, as expected, we've received a complete response letter for EVENITY from the FDA, and will be responding with the data from the ARCH study and the BRIDGE study in men with osteoporosis. Along with our colleagues at UCB, we're currently in the process of reviewing the detailed ARCH data with experts. This will be a Class II resubmission in the U.S. which carries a 6-month review time line. We believe there are patients for whom the benefit risk of EVENITY would be favorable, and we will work with regulators on a path forward.
在我們的骨骼健康治療領域,正如預期的那樣,我們收到了 FDA 對 EVENITY 的完整回覆函,我們將根據 ARCH 研究和 BRIDGE 研究的數據對患有骨質疏鬆症的男性進行回應。目前,我們正與 UCB 的同事和專家一起審查 ARCH 的詳細數據。這將是美國第二類重新提交的申請,審查時間為 6 個月。我們相信,對於某些患者而言,EVENITY 的獲益風險是有利的,我們將與監管機構合作,尋找前進的方向。
In our neuroscience collaboration with Novartis, we've submitted erenumab, now known as Aimovig, to global regulators for the prevention of migraine and have received a PDUFA date of May 17, 2018. We recently presented data from erenumab program at U.S. and E.U. medical conferences and the feedback on the efficacy and safety profile continues to be very positive.
在我們與諾華的神經科學合作中,我們已向全球監管機構提交了用於預防偏頭痛的erenumab(現稱為Aimovig),並已收到2018年5月17日的PDUFA日期。我們最近在美國和歐盟的醫學會議上展示了erenumab計畫的數據,關於其療效和安全性的回饋仍然非常積極。
In our beta-secretase program for Alzheimer's disease, we're expanding the development of CNP520 to individuals who carry 1 copy of the APOE4 allele and also have evidence of brain amyloid accumulation. This will be assessed in an approximately 2,000 subject trial that will be starting soon, and combined with the ongoing Phase III study evaluating CMP520 and APOE4 homozygotes will constitute a robust dataset in an at-risk population. Given how early beta amyloid starts to accumulate in the course of the disease, we feel that a therapy like a BACE1 inhibitor should be administered as early as is feasible. This, combined with the strong genetic validation for specifically targeting BACE via deCODE's work, gives us great confidence in our approach.
在我們的阿茲海默症β-分泌酶計畫中,我們將CNP520的開發範圍擴大到攜帶1個APOE4等位基因拷貝且有腦澱粉樣蛋白累積證據的個體。我們將在一項約有 2000 名受試者參與的試驗中進行評估,該試驗即將開始,並將與正在進行的評估 CMP520 和 APOE4 純合子的 III 期研究相結合,從而在高危險群中形成一個可靠的數據集。鑑於β澱粉樣蛋白在疾病早期就開始積累,我們認為應該儘早使用BACE1抑制劑等療法。這一點,再加上 deCODE 的研究成果對專門針對 BACE 的強有力的基因驗證,使我們對我們的方法充滿信心。
And finally, in our biosimilars program, we received the unanimous vote from an FDA advisory committee in favor of approval of ABP 215, our biosimilar Avastin, which has a user fee action date in September of this year.
最後,在我們的生物相似藥計畫中,我們獲得了 FDA 諮詢委員會的一致投票,贊成批准我們的生物相似藥 Avastin ABP 215,該藥物將於今年 9 月進行用戶收費操作。
As always, I want to thank our staff for continuing to deliver on these important milestones for the benefit of patients. Bob?
一如既往,我要感謝我們的員工,感謝他們為造福病人而不斷完成這些重要的里程碑。鮑伯?
Robert A. Bradway - Chairman and CEO
Robert A. Bradway - Chairman and CEO
Okay, thank you, Sean. And Skinner, let's open the line up for questions. Please remind our callers about the process for asking this afternoon.
好的,謝謝你,肖恩。史金納,現在開始接受提問。請提醒來電者今天下午的諮詢流程。
Operator
Operator
(Operator Instructions) Our first question comes from Matthew Harrison from Morgan Stanley.
(操作員說明)我們的第一個問題來自摩根士丹利的馬修·哈里森。
Matthew Kelsey Harrison - Executive Director
Matthew Kelsey Harrison - Executive Director
If I could just ask a clarifying question here on Enbrel, that would be helpful. So I believe you said in the fourth quarter, you had $150 million inventory build, and then I can't remember, I think you either said you had a $20 million or $30 million burn off. In the first quarter, now you said you're back at $140 million. So can you just review for us sort of the sequential pattern here? And did you have an inventory build quarter-over-quarter? And I guess, should we expect all of this $140 million to burn off in the second half of the year? How do you expect that to play out?
如果我能在這裡問一個關於恩利(Enbrel)的疑問,那就太好了。我相信你說過,在第四季度,你們增加了 1.5 億美元的庫存,然後我記不清了,我想你說你們消耗了 2000 萬美元或 3000 萬美元的庫存。第一季度,你說你們的業績已經恢復到 1.4 億美元。那麼,您能幫我們回顧這裡的順序模式嗎?你們的庫存季增了嗎?那麼,我們是否可以預期這 1.4 億美元會在今年下半年全部消耗掉呢?你覺得事情會如何發展?
Robert A. Bradway - Chairman and CEO
Robert A. Bradway - Chairman and CEO
Sure. Thanks, Matthew. I'll ask Tony to respond.
當然。謝謝你,馬修。我會請托尼回覆。
Anthony C. Hooper - EVP of Global Commercial Operations
Anthony C. Hooper - EVP of Global Commercial Operations
Matt, it's Tony. So let me go back to discussing the inventory. So inventory, as I said, we report at a point in time, so it's either on the 31st of March or it is the 30th of June, so it's an endpoint. What we have in hand is we know exactly what the revenue numbers are in terms of ex-factory sales. We also understand what our in-market demand is based on the IMS retail prescriptions, which are about 90% accurate and 10% predicted. We also understand exactly what are held by the wholesalers because of our contracts with them and the triangulation between how much has been sold from wholesalers to end users minus the demand, leaves us with a number which we then extrapolate as being the end-user inventory. So clearly, what happens is at the beginning of the quarter, there's a drawdown of that inventory which we did see in April, May this year, and then there appeared to be a build towards the end of June. So what I'm saying is we ended the quarter with an excess of about $140 million of inventory which I would expect to burn off the majority of that during the rest of the year.
馬特,我是東尼。那麼,讓我們回到庫存問題的討論。正如我所說,庫存數據是在某個時間點報告的,所以要么是 3 月 31 日,要么是 6 月 30 日,這是一個終點。我們掌握的資訊是,我們確切知道出廠銷售額的收入數字是多少。我們也根據 IMS 零售處方了解了我們的市場需求,這些處方約有 90% 的準確率和 10% 的預測值。由於我們與批發商簽訂了合同,我們也確切地知道批發商持有多少庫存。透過批發商向最終用戶銷售的數量減去需求量,我們得出了一個數字,然後我們將其推斷為最終用戶的庫存。很明顯,季度初庫存會下降,我們在今年 4 月和 5 月就看到了這種情況,然後在 6 月底似乎又出現了庫存增加。所以我的意思是,本季末我們庫存過剩約 1.4 億美元,我預計今年剩餘時間內大部分庫存將會消耗掉。
Operator
Operator
Our next question comes from Eric Schmidt from Cowen and Company.
我們的下一個問題來自 Cowen and Company 的 Eric Schmidt。
Eric Thomas Schmidt - MD and Senior Research Analyst
Eric Thomas Schmidt - MD and Senior Research Analyst
Maybe for Sean in this ACC decision pathway document that soon will be coming out here shortly. Can you just talk about the impact of the decision pathway as relative to the actual treatment guidelines, which I think the ACC expects to put out in 2018? And also, if you think there's going to be an immediate or relatively near-term impact for the decision pathway document, what payers have to maybe do to comply?
或許肖恩的情況會在這個即將發布的 ACC 決策路徑文件中得到體現。您能否談談決策路徑相對於實際治療指引的影響?我認為 ACC 預計將於 2018 年發布這些指南。此外,如果您認為決策路徑文件將立即或相對近期產生影響,那麼付款方可能需要採取哪些措施來遵守規定?
Sean E. Harper - EVP of Research and Development
Sean E. Harper - EVP of Research and Development
Yes. It's a great question. I mean, I think that in my experience with these documents, the guideline process is one which is slight complex, involves a systematic review of the world's literature by a very large group of international experts and has to kind of occur on a cadence of every 2 to 3 years. And also the result is if you've ever looked at one of these guidelines, it's a long complex technical document designed for people who are really expert in the field. Because of that cadence and because of the need to produce something that is more usable to the practicing clinician, these pathway documents emerged. And they are important reference documents for physicians to think about how to deal with patients who come in and present themselves. And this is the first time, to my knowledge, that one of these pathway documents has been updated outside of its normal schedule. And that's because the pathway documents, in part, are designed to deal with just the situation where new important clinical information, particularly the quality of information that's come from both our outcomes trial as well as the Pfizer outcomes trial with PCSK9 have come on the scene and publications have become available. So it's an important step. It's -- this is a document that is used quite a bit in clinical decision-making. And generally speaking, but not always, these kind of changes that you see in these documents then roll in and become incorporated in the formal guidelines, which will come out, as you say, probably '18, late '18, is our best knowledge. In terms of immediate impact, I'd say, it's a little bit hard to judge. I think there's an accumulating weight of evidence that the professional societies around the world, including very important ones in the U.S. like the lipid society and the endocrine societies and now ACC, are beginning to converge in their opinions around the importance of LDL lowering and the impact that one sees both the safety profile as well as the efficacy of using Repatha in particular. And so I do expect that payers will responsibly look at these guidelines and recommendations, and begin to try to make it possible for the doctors who practice in their plans to practice in a way that's consistent with this professional recommendation.
是的。這是一個很好的問題。我的意思是,根據我接觸這些文件的經驗,我認為指南制定過程是一個稍微複雜的過程,它涉及由一大群國際專家對世界文獻進行系統審查,並且必須每 2 到 3 年進行一次。而且,如果你看過這些指南中的任何一篇,你會發現它是一份冗長而複雜的專業技術文檔,是為該領域的真正專家設計的。由於這種節奏,以及為了製作對臨床醫生更有用的資料,這些路徑文件應運而生。這些文件對於醫生來說非常重要,可以幫助他們思考如何處理前來就診的患者。據我所知,這是這些路徑檔案首次在正常時間表之外進行更新。這是因為路徑文件在一定程度上是為了應對新的重要臨床資訊(特別是來自我們的結果試驗以及輝瑞公司針對 PCSK9 的結果試驗的資訊品質)出現並發表的情況而設計的。所以這是重要的一步。這是一份在臨床決策中常用到的文件。一般來說(但不總是如此),你在這些文件中看到的這些變化會逐漸被納入正式指南中,正如你所說,這些指南可能會在 2018 年或 2018 年底發布,據我們所知。就直接影響而言,我覺得有點難以判斷。我認為越來越多的證據表明,世界各地的專業學會,包括美國一些非常重要的學會,如脂質學會、內分泌學會以及現在的美國心臟病學會(ACC),在降低低密度脂蛋白膽固醇(LDL)的重要性以及使用瑞百安(Repatha)的安全性和有效性方面的影響方面,開始達成共識。因此,我希望支付方能夠負責任地審視這些指導方針和建議,並開始努力使在其計劃中執業的醫生能夠以符合這些專業建議的方式行醫。
Robert A. Bradway - Chairman and CEO
Robert A. Bradway - Chairman and CEO
Eric, why don't we ask Tony to share a few thoughts as well on the payer perspective in your question.
艾瑞克,我們不妨也請東尼就你提出的問題,從付款方的角度分享一些想法。
Anthony C. Hooper - EVP of Global Commercial Operations
Anthony C. Hooper - EVP of Global Commercial Operations
So I mean, it's clear to us, Eric, that in our discussion with the payers, they do pay very careful attention to position papers and the guidelines coming from these bodies. And the National Lipid Association is a subdivision of the AHA, so it's clear they're making those decision on that regard. The ACC, of course, has always been the granddaddy of guidelines and people will pay definitive attention and look at how they will be actually serving patients aligned with these position papers or pathways that the ACC have put into place. So we're working extensively with them at the moment. As Sean said, as the weight of evidence continues to build around the importance of delivering Repatha to patients who do have this particular disease.
所以我的意思是,埃里克,我們很清楚,在與付款方的討論中,他們確實非常認真地關注這些機構發布的立場文件和指導方針。而美國國家脂質協會是美國心臟協會的一個分支機構,所以很明顯,他們在這方面所做的決定。當然,ACC 一直是指南的權威,人們會格外關注並研究如何真正按照 ACC 制定的立場文件或路徑為患者提供服務。所以目前我們正在與他們進行廣泛的合作。正如肖恩所說,越來越多的證據表明,向患有這種特定疾病的患者提供瑞百安(Repatha)非常重要。
Operator
Operator
Our next question comes from Ying Huang from Bank of America Merrill Lynch.
下一個問題來自美國銀行美林證券的黃穎。
Ying Huang - Director in Equity Research
Ying Huang - Director in Equity Research
My first one has to do with the balance sheet. You have a $39 billion cash on balance sheet. If you guys don't have any plans to -- concerning M&A transactions or repay the debt, many investors is wondering whether you have any plans to repurchase a significant portion of the float, the shares? And then maybe for Sean, when might you know whether FDA would require a cardiovascular safety study for romosozumab? And if so, would you continue the development or not for romosozumab?
我的第一個問題與資產負債表有關。貴公司資產負債表上有390億美元的現金。如果你們沒有關於併購交易或償還債務的計劃,許多投資者想知道你們是否有計劃回購相當一部分流通股?那麼,對肖恩來說,你什麼時候才能知道FDA是否會要求對romosozumab進行心血管安全性研究呢?如果是這樣,您會繼續開發 romosozumab 嗎?
Robert A. Bradway - Chairman and CEO
Robert A. Bradway - Chairman and CEO
Okay. Ying, why don't I take the first question. Invite David to add any color if he'd like. And then Sean, you can briefly answer the romo question. On -- with respect to balance sheet, I think, again, you're aware our business is generating significant cash flows. We have a track record of wanting to use that cash flow to pay dividends to our shareholders, a rapidly growing dividend as well as to buy back stock and to invest in the business. So we're optimistic about the outlook for the business, as I say, continue to generate strong cash flow, we have a strong balance sheet and we'll look at ways of deploying that capital as appropriate through time. And David, maybe you'd like to update on where we are with respect to the capital commitments that we've made or share.
好的。瑩,不如我來回答第一個問題吧。邀請大衛根據自己的喜好添加任何顏色。然後肖恩,你可以簡單回答一下關於羅莫的問題。關於資產負債表,我想,您也知道,我們的業務正在產生大量的現金流。我們一直以來都希望利用這些現金流向股東支付股息,並實現股息的快速成長,同時也回購股票和投資公司業務。因此,我們對公司前景持樂觀態度,正如我所說,我們將繼續產生強勁的現金流,我們擁有穩健的資產負債表,我們將隨著時間的推移,尋找適當的方式來部署這些資本。大衛,或許你可以介紹一下我們目前在已做出或已分享的資本承諾方面的情況。
David W. Meline - CFO and EVP
David W. Meline - CFO and EVP
Yes. So I would just add to that 2 things. One is that we continue with the plan, as I said, to return 60% of net income through '18 to shareholders, and I think that is certainly something we'll execute on going forward. And I think the second point, as many know, the vast majority of the cash that we're holding does sit offshore. And we don't see right now that it would be appropriate to repatriate it under the current U.S. tax system. So obviously as and when they make progress on tax reform and make it more reasonable to consider repatriation, would we then take a look and start providing some commentary on how we might deploy that.
是的。所以我還要補充兩點。一方面,正如我所說,我們將繼續執行計劃,將 2018 年淨收入的 60% 返還給股東,我認為這肯定是我們今後會執行的事情。我認為第二點是,正如許多人所知,我們持有的絕大部分現金都存放在海外。我們認為,根據目前的美國稅收制度,現在將這筆錢匯回國內並不合適。所以很顯然,當他們在稅制改革方面取得進展,使資金回流變得更加合理時,我們會進行研究,並開始就如何運用這些措施發表一些評論。
Sean E. Harper - EVP of Research and Development
Sean E. Harper - EVP of Research and Development
And with respect to romosozumab, I think we're -- it's just too early in the process to comment meaningfully on whether additional studies would be appropriate and whether they would be a good investment for our shareholders and UCB shareholders. We have to go through a process that's going to take some time to discuss these results formally with regulators.
至於 romosozumab,我認為現在還處於早期階段,無法就是否需要進行更多研究以及這些研究對我們的股東和 UCB 股東來說是否是一項好的投資發表有意義的評論。我們需要經過一個耗時的過程,才能與監管機構正式討論這些結果。
Operator
Operator
Our next question comes from Terence Flynn from Goldman Sachs.
下一個問題來自高盛的特倫斯·弗林。
Terence C. Flynn - MD
Terence C. Flynn - MD
Maybe two part from me. Just wondering, following the romo safety signal, if your BD priorities have changed at all either with respect to size, stage or disease areas of interest? And then on the guidance, just wondering if you can talk about the changes on the revenue side, particularly lowering at the top end, what the driver or drivers of that was.
也許我分兩部分。想問一下,在收到 romo 安全訊號後,您在 BD 方面的優先事項是否有所改變,無論是在規模、階段還是感興趣的疾病領域?關於業績指引,我想請您談談收入方面的變化,特別是高端收入的下降,背後的驅動因素是什麼?
Robert A. Bradway - Chairman and CEO
Robert A. Bradway - Chairman and CEO
We'll do this in 2 parts as well then. With respect to romo and the impact on our BD thinking, I don't think it has any direct impact, Terence on how we're looking at the opportunities of business development. And David, do you want to talk a little bit more...?
那麼,我們也分兩部分進行。關於 Romo 及其對我們業務發展思路的影響,我認為它對我們如何看待業務發展機會沒有任何直接影響,Terence。大衛,你還想再說一會兒嗎?
David W. Meline - CFO and EVP
David W. Meline - CFO and EVP
Sure. In terms of guidance, if you might recall, when we entered the year, we provided revenue guidance that was broader than traditionally we would have because of, in particular, the uncertainties around the evolution of the sales of Repatha which related to this question of the outcomes trial being published as well as the ongoing litigation that's taking place. And so now as we sit at midyear and look at the trajectory of the business, the good news for us is the revenue is evolving as we'd set out for the company through the year. And indeed, the earnings performance is quite good and we've raised again our EPS for the year. So really, what we're doing now is we're narrowing the guidance to reflect the fact that as we look to the balance of the year, we don't have the most positive upside that might have occurred if there had been an early decision on the litigation. We are awaiting the outcome of that, and then we're also reflecting the trajectory which we're encouraged by the uptake of Repatha, which we think will continue to accelerate. And so the guidance simply reflects the best estimate we have right now.
當然。就業績效指引而言,您可能還記得,年初時我們提供的收入指引比以往更為寬泛,這主要是因為 Repatha 的銷售發展存在不確定性,這與即將公佈的試驗結果以及正在進行的訴訟有關。因此,現在到了年中,當我們審視公司的發展軌跡時,對我們來說的好消息是,收入正在按照我們今年為公司設定的目標發展。事實上,獲利表現相當不錯,我們再次上調了今年的每股盈餘預期。所以,我們現在所做的,實際上是縮小了業績指引的範圍,以反映這樣一個事實:展望今年剩餘時間,如果訴訟早點做出決定,我們可能會獲得最大的利好。我們正在等待結果,同時我們也注意到,Repatha 的普及速度令人鼓舞,我們認為這一速度將繼續加快。因此,該指導意見僅僅反映了我們目前所能得到的最佳估計。
Operator
Operator
Our next question comes from the line of Michael Yee from Jefferies.
我們的下一個問題來自傑富瑞集團的邁克爾葉。
Michael Jonathan Yee - Equity Analyst
Michael Jonathan Yee - Equity Analyst
My question is in relation to your longer-term guidance and your margin guidance, 52% to 54%, you're at the higher end of that. And next year, you're not necessarily going to face so much biosimilar competition. So can you talk about where and when you could think about reassessing that? And importantly, if you think that these margins can be sustained or managed even in the face of potential future biosimilar risk?
我的問題是關於你們的長期績效指引和利潤率指引,52%到54%,你們的指引處於較高水準。明年,你未必會面臨那麼多生物相似藥的競爭。那麼,您能否談談您會在何時何地考慮重新評估這個問題?更重要的是,您是否認為即使面對未來潛在的生物相似藥風險,這些利潤率也能維持或控制?
Robert A. Bradway - Chairman and CEO
Robert A. Bradway - Chairman and CEO
Sure. Yes, so I would say, first of all, you're correct on our margin performance. We've been pleased with how it's evolved for the company, given that we set that goal out at a time we were delivering 38% operating margin. So it was quite a big task for the company but you've seen it evolve very nicely. And I think, importantly, for us, during that time, we've also stood up a very significant cardiovascular franchise. We're in the process today of investing in preparation of our first launch in the neurology sector. We've been building out and are on track with our portfolio of biosimilars, and we've added several hundred million dollars a year of structural costs to our international network as we build out globally. So not only are we seeing margin improvement, but also we've been building a base for the company which is going to be very important for our sustainability going forward. In terms of as and when we would then look forward and what do we think about margins for the company, I would say we're approaching now the end of the period that we gave guidance through '18. So obviously, within this next year, 1.5 years, we'll have a look and start providing some additional views of the future for the company. But at least as we sit here today, we feel very good about not only the performance of the company and the prospects, but also the sustainability of that profitability.
當然。是的,所以首先我想說,您對我們的利潤率表現的判斷是正確的。考慮到我們當初設定這個目標時,公司的營業利潤率只有 38%,我們對公司的發展現況感到滿意。所以這對公司來說是一項相當大的任務,但你們也看到了它發展得非常順利。而且我認為,對我們來說更重要的是,在那段時間裡,我們也建立了一個非常重要的心血管業務部門。我們目前正在進行投資,為我們在神經病學領域的首次產品發布做準備。我們一直在擴大生物相似藥產品組合,並且進展順利。隨著我們在全球擴張,我們的國際網路每年增加了數億美元的結構性成本。因此,我們不僅看到了利潤率的提高,而且還為公司打下了基礎,這對我們未來的永續發展至關重要。至於我們何時展望未來以及我們對公司利潤率的看法,我認為我們現在正接近我們給出的 2018 年業績指引期的尾聲。顯然,在接下來的1年半時間裡,我們將檢視並開始提供一些關於公司未來的其他觀點。但至少就我們今天所處的位置而言,我們不僅為公司的業績和前景感到非常滿意,而且對盈利能力的可持續性感到非常滿意。
Operator
Operator
Our next question comes from Geoffrey Porges from Leerink Partners LLC.
我們的下一個問題來自 Leerink Partners LLC 的 Geoffrey Porges。
Geoffrey Craig Porges - MD, Biotechnology, Director of Therapeutics Research and Senior Biotechnology Analyst
Geoffrey Craig Porges - MD, Biotechnology, Director of Therapeutics Research and Senior Biotechnology Analyst
I just want to have a little discussion on Aimovig or hear your thoughts on it. You've said that you're likely to be first and I know you can't really comment on pricing. But certainly, the PCSK9 experience was sobering for all of us in terms of the payer response. And I'm just wondering how your discussions with payers are going? What sort of step edits you would expect for people to get access to Aimovig? And then should we be expecting pricing that's more at the Prolia end of the spectrum? Or more at the Repatha end of the spectrum?
我只是想和大家討論Aimovig,或是聽聽你們的看法。你說過你很可能是第一個,我知道你無法對價格發表評論。但可以肯定的是,就支付方的反應而言,PCSK9 的經驗讓我們所有人都清醒地認識到了這一點。我想知道您與付款方的討論進度如何?您認為人們需要進行哪些步驟修改才能獲得 Aimovig 的使用權限?那麼,我們是否可以預期它的定價會更接近 Prolia 的價格水準呢?或更接近瑞百安(Repatha)那種類型的止痛藥?
Anthony C. Hooper - EVP of Global Commercial Operations
Anthony C. Hooper - EVP of Global Commercial Operations
So Geoff, this is Tony. I mean, one, we have never given pricing guidance prior to a launch. Aimovig is going into a patient population that are uniquely different from a symptomatic perspective, right? So they -- we estimate about 3.4 million patients presently on prophylactic treatment for migraine, both episodic and chronic, which is a crippling disease resulting in mothers not being able to be mothers, or employees not being able to do their work. And our discussions have been with payers, from a clinical perspective at this particular stage, as we move things forward. And there's a huge unmet need and we're busy developing our pharmacoeconomic value-based pricing models for this particular disease. It's going to be a competitive market, that we understand. But our pricing will be made as we get closer to the launch time.
傑夫,這位是托尼。我的意思是,第一,我們從未在產品發布前給出過定價指引。Aimovig 的目標患者群體在症狀方面與其他患者群體截然不同,對嗎?因此,據估計,目前約有 340 萬名患者正在接受偏頭痛(包括發作性偏頭痛和慢性偏頭痛)的預防性治療,這是一種致殘性疾病,導致母親無法履行母親的職責,或員工無法工作。現階段,我們一直在與支付方進行討論,並從臨床角度推進各項工作。目前存在巨大的未滿足需求,我們正在努力為這種特定疾病開發基於藥物經濟學價值的定價模型。我們明白,這將會是一個競爭激烈的市場。但我們的定價將在接近發布日期時確定。
Operator
Operator
Our next question comes from Ian Somaiya from BMO Capital Markets.
下一個問題來自 BMO 資本市場的 Ian Somaiya。
Mayur Amrat Somaiya - Analyst
Mayur Amrat Somaiya - Analyst
I was just trying to better understand the drivers of Repatha until we get to the publication of the ACC treatment guidelines at the end of next year. Specifically, just 2 different -- 2 subgroups that payers and physicians have a lot of interest in. Seeing results for diabetic smokers. And then just separately, at the time of the ACC presentation, the follow-up was roughly 2.2 years, was wondering when we could see follow-up or data following patients for greater than 3 years?
我只是想更了解 Repatha 的作用機制,直到明年年底 ACC 治療指南發布為止。具體來說,只有 2 個不同的——支付方和醫生非常感興趣的 2 個亞群體。糖尿病吸煙者已取得成效。另外,在 ACC 會議上,追蹤時間約為 2.2 年,我想知道我們什麼時候才能看到超過 3 年的追蹤數據?
Robert A. Bradway - Chairman and CEO
Robert A. Bradway - Chairman and CEO
Okay. Why don't we do this in 2 parts. Tony, why don't you talk a little bit about what we expect to see between now and when we have the outcomes data and the label, what the drivers are. And then Sean, you address the follow-up question.
好的。我們為什麼不分兩個部分來做呢?東尼,你能否談談從現在到我們獲得結果數據和標籤之間,我們預期會看到什麼,以及驅動因素是什麼?然後肖恩,你來回答後續問題。
Anthony C. Hooper - EVP of Global Commercial Operations
Anthony C. Hooper - EVP of Global Commercial Operations
So when we look at the actual usage in the marketplace, right, there are 3 patient segments that are popping to us that are clearly indicated inside the label and where physicians start to understand there's important to treat, right? These are patients who have ASCVD, who've had 2 events in the last 24 months, clearly high-risk patients or what we call high, high-risk patients. There are those who have ACS who have had an event in the last year or so with ASCVD. And then there's the FH population. That's a fairly large population and we've seen the majority of our patients coming from that group at the moment. If you look at the NRx data, which is really looking at the new to brand prescriptions in terms of new patient capture, you are seeing that we're gaining market share there and gaining traction consistently in terms of getting patients. When you look inside the data and you see that the abandonment rate by commercial patients has gone down to about 24%. It's clear that we are assisting patients who can't afford their copay or their deductibles, so we're getting a higher access to patients there. So we see a continued usage and expansion by existing physicians. We're capturing about between 300 and 400 new prescribers per month, so the prescriber base is growing as we go forward. The new guidelines will start to take a little bit of traction for physicians to understand. We look forward to the ACC presentations. So that's where we see the growth of our business right now.
所以,當我們觀察市場上的實際使用情況時,我們發現了三個患者群體,這些群體在標籤中都有明確的指示,醫生們也開始意識到治療這些群體的重要性,對吧?這些患者患有 ASCVD,在過去 24 個月內發生過 2 次事件,顯然是高風險患者,或我們稱之為極高風險患者。有些患有 ACS 的人在過去一年左右的時間裡發生了 ASCVD 事件。還有FH人口。這是一個相當大的群體,目前我們的患者大多來自這個群體。如果你查看 NRx 數據(該數據實際上是在關注新患者獲取方面新品牌處方),你會發現我們在該領域獲得了市場份額,並且在獲取患者方面持續獲得進展。當你查看數據時,你會發現商業患者的放棄率已下降到約 24%。很明顯,我們正在幫助那些負擔不起共付額或自付額的患者,因此我們能夠更好地服務這些患者。因此,我們看到現有醫生繼續使用並擴大使用範圍。我們每月大約新增 300 至 400 名處方醫生,因此,隨著我們不斷前進,處方醫生群體也在不斷壯大。新的指導方針會逐漸被醫生理解並接受。我們期待ACC的報告。這就是我們目前看到業務成長的地方。
Sean E. Harper - EVP of Research and Development
Sean E. Harper - EVP of Research and Development
And then with respect to the insights into the data on diabetics and smokers, there were a very substantial portion of type 2 diabetics in FOURIER and about 30% of the population were smokers. And essentially, when you look at those subgroups in comparison to the whole study, the data were virtually identical. So there we did see, as you might expect with LDL lowering and as has been seen with statins, that it has to be sort of uniform effect across these type of clinical populations. Obviously, the controlled portion of the FOURIER study is complete but there is, I think, you're referring to long-term extension kind of data that is available. As you might recall, we had over 4 years of long-term extension data, treatment data at the time of presentation of FOURIER published at that time in one of the major journals. And we have a long-term extension of approximately 5,000 patients from FOURIER as well who will run out for an additional number of years, perhaps up to 10, we'll figure that out as we go along. But that is designed to be a leading indicator of any safety issues that might not have presented themselves in the window of the FOURIER study, which was, as you point out, just 2.2 years.
至於對糖尿病患者和吸菸者數據的洞察,FOURIER 中有相當大比例的 2 型糖尿病患者,約 30% 的人口是吸菸者。本質上,當你將這些子組與整個研究進行比較時,你會發現數據幾乎完全相同。因此,正如你可能預料到的,降低 LDL 以及他汀類藥物的作用一樣,我們看到,對於這類臨床人群而言,其效果必須是某種統一的。顯然,FOURIER 研究的受控部分已經完成,但我認為,你指的是長期擴展數據。您可能還記得,我們在 FOURIER 發表時,有超過 4 年的長期擴展數據和治療數據,這些數據當時已發表在一家主要期刊上。此外,我們還有來自 FOURIER 的大約 5,000 名患者的長期延期,他們的治療將持續數年,可能長達 10 年,我們會邊走邊看。但其目的是為了提前發現一些安全性問題,這些問題可能在 FOURIER 研究的時間窗口內沒有顯現出來,正如你所指出的,FOURIER 研究的時間窗口只有 2.2 年。
Operator
Operator
And our next question comes from Geoffrey Meacham from Barclays.
下一個問題來自巴克萊銀行的傑弗裡·米查姆。
Geoffrey Christopher Meacham - MD and Senior Research Analyst
Geoffrey Christopher Meacham - MD and Senior Research Analyst
I have one on Repatha for either Sean or Tony. And I guess, the question is more in demand trends post-ACC in this year. I'm just trying to get a sense for when payer policy and guidelines become more favorable? If you guys would expect any hurdles at the actual prescriber level at the cardiovascular, at the treating physician level? Or if patient persistent rates over time have really changed materially?
我有一個關於Repatha的,是給Sean或Tony的。我想,問題更多的是今年ACC之後的需求趨勢。我只是想了解支付方的政策和指導方針何時會變得更加有利?你們認為在心血管領域,在實際開立處方醫師層面,也就是治療醫師層面,會遇到哪些障礙?或者說,患者持續就診率是否真的隨時間發生了實質變化?
Anthony C. Hooper - EVP of Global Commercial Operations
Anthony C. Hooper - EVP of Global Commercial Operations
So Geoff, let me take that one as best I can at the moment. So just to remind you that the outcomes data were presented at the ACC in March, we are not promoting that data at the moment. We are clearly awaiting the FDA decision to include the data in our label at which stage, we will start being able to promote that data into the marketplace. So we are working consistently with the payers at the moment in terms of reevaluating and challenging some of the utilization management criteria, challenging some of the onerous processes that are in place and actually working with the professional bodies themselves, so they become involved in ensuring they can get access to their patients. We have seen a high level of willingness from the payers and the PBMs to relook at the utilization management criteria to ensure that the processes are reasonable. The cohorts are probably a bit too small to be able to really understand patient persistency at the moment. So what we are tracking is new patient capture early on. And as you know, you can see that quite easily from the IMS data and that continues to grow as well as to grow trialists as we go forward. We do believe that once the FDA ratifies the data and puts it in the label, we'll be in a much better decision to see an opening of access through the payers.
傑夫,讓我現在盡我所能來回答這個問題。再次提醒各位,結果數據已於 3 月在 ACC 會議上公佈,我們目前並未宣傳這些數據。我們顯然正在等待 FDA 決定是否將這些數據納入我們的標籤,屆時我們將能夠開始向市場推廣這些數據。因此,我們目前正與支付方持續合作,重新評估和質疑一些利用管理標準,質疑一些繁瑣的流程,並實際與專業機構合作,以便他們參與進來,確保他們能夠接觸到患者。我們看到,支付者和藥品福利管理機構都非常願意重新審視利用管理標準,以確保流程合理。目前這些隊列的規模可能還太小,不足以真正了解患者的堅持治療。所以我們追蹤的是早期新患者的獲取情況。如您所知,從 IMS 數據中可以輕鬆看出這一點,而且隨著我們不斷推進,試驗參與者數量也在持續增長。我們相信,一旦 FDA 批准這些數據並將其納入標籤,我們就能更好地做出決定,從而透過支付方獲得准入。
Operator
Operator
Our next question comes from Cory Kasimov from JPMorgan.
下一個問題來自摩根大通的科里·卡西莫夫。
Cory William Kasimov - Senior Biotechnology Analyst
Cory William Kasimov - Senior Biotechnology Analyst
I wanted to follow up on erenumab. And on their call this morning, Lilly mentioned that they haven't seen any competitive CGRP data that they view as better than what they've generated. So I'm wondering if you can talk a little bit about how you see this market? And how you maybe plan to potentially differentiate erenumab or Aimovig, in this set as you begin to get a better feel for the various profiles of other agents in the class? Or is this something that really just comes down to first to market and potentially price as you were asked about before?
我想了解一下erenumab的情況。在今天早上的電話會議上,禮來公司提到,他們還沒有看到任何競爭對手的 CGRP 數據比他們自己產生的數據更好。所以我想請您談談您對這個市場的看法?當您開始更了解該類藥物中其他藥物的各種特性時,您打算如何區分erenumab或Aimovig呢?或者,正如之前有人問到的那樣,這真的只是取決於搶佔市場先機和價格因素嗎?
Anthony C. Hooper - EVP of Global Commercial Operations
Anthony C. Hooper - EVP of Global Commercial Operations
Okay. So let me start doing a little bit of an answer there, if I can and perhaps Sean can add around the clinical data, right? So just to go back, my comment to Geoff earlier on around the unmet need. The more we dig into this market, the more you realize that not only patients, but specialists, physicians themselves have been absolutely frustrated for decades because of the inability to actually prescribe a migraine drug for a migraine. They've used substitutes. They've used drugs that have caused huge side effects and patients are unhappy with them. So as we talked to patients, patient bloggers, patient groups about their needs, it's clearly unmet need continues to be large. Every specialist I've spoken to that looked at the Aimovig data has been impressed by the data, has seen a dramatic potential change in what this will do for patients on their day-to-day lives. We do believe that we will be first to market. We have submitted first. We intend coming to market first. We have a partnership with Novartis, who have an existing strong relationship with the neurologists, a lot of them who treat migraine. And we expect to be using their skills, competencies and relationships to set us up and to move fast and quickly into the marketplace.
好的。那麼,讓我先簡單回答一下這個問題,如果可以的話,也許肖恩可以補充一些臨床數據,對吧?所以,回到我之前對 Geoff 提到的未被滿足的需求。我們越深入研究這個市場,就越會發現,不僅是患者,就連專家和醫生本身也因為無法真正為偏頭痛開具偏頭痛藥物而感到十分沮喪,這種情況已經持續了幾十年。他們使用了替代品。他們使用的藥物造成了巨大的副作用,患者對此感到不滿。因此,當我們與患者、患者部落客、患者團體談論他們的需求時,很明顯,未滿足的需求仍然很大。我採訪過的每一位看過 Aimovig 數據的專家都對這些數據印象深刻,他們認為這將為患者的日常生活帶來巨大的改變。我們堅信我們將率先進入市場。我們先提交了。我們打算率先進入市場。我們與諾華公司建立了合作關係,諾華公司與神經科醫生有著牢固的關係,其中許多神經科醫生都治療偏頭痛。我們期望利用他們的技能、能力和人脈關係,為我們做好準備,並迅速進入市場。
Sean E. Harper - EVP of Research and Development
Sean E. Harper - EVP of Research and Development
And my only additional comment would be that because the other agents are not receptor antagonists and are ligand directed, they're less potent and the amount of antibody required to achieve the clinical effect is considerably higher. This results in things like loading doses or IV administration or multiple large volumes subcu administrations required at the same time. And none of those are positives for patients. So we know we can get erenumab to a monthly single, small volume, well-tolerated auto injection. I don't know that that's possible with these other agents. The data, as it appears to me at this point, doesn't suggest that.
我唯一要補充的是,由於其他藥物不是受體拮抗劑,而是配體導向劑,因此它們的效力較低,達到臨床效果所需的抗體量要高得多。這導致需要同時進行負荷劑量、靜脈注射或多次大劑量皮下注射等操作。這些對患者來說都不是好事。所以我們知道我們可以將依瑞奈單抗製成每月一次、小劑量、耐受性良好的自動注射劑。我不知道其他代理商是否也能做到這一點。就我目前所見,數據並沒有顯示這一點。
Operator
Operator
Our next question comes from Robyn Karnauskas from Citi.
下一個問題來自花旗銀行的 Robyn Karnauskas。
Robyn Karnauskas - Director and Senior Analyst
Robyn Karnauskas - Director and Senior Analyst
Given the pushback So far with the payers in the cardiovascular space that you've seen with Repatha, like how are you thinking about the bar for developing your CETP inhibitor? And what threshold do you want to see with the Merck data that will make you feel more positive about the prospect of the class?
鑑於目前心血管領域支付方對瑞百安(Repatha)的抵制,您如何看待開發 CETP 抑制劑的門檻?您希望默克的數據達到什麼閾值,才能讓您對這類藥物的前景更加樂觀?
Robert A. Bradway - Chairman and CEO
Robert A. Bradway - Chairman and CEO
I think we're focused, Robyn, on unmet medical need and trying to figure out whether that class of agents has a role to play. But Sean, I'll let you talk about the specifics. And obviously, we need to believe that we can earn a return on any further investment there for our shareholders. Do you want to talk about the clinical?
羅賓,我認為我們關注的是未被滿足的醫療需求,並試圖弄清楚這類藥物是否能發揮作用。但是肖恩,具體細節就交給你來說吧。顯然,我們需要相信,我們能夠為股東從任何進一步的投資中獲得回報。你想談談臨床方面的問題嗎?
Sean E. Harper - EVP of Research and Development
Sean E. Harper - EVP of Research and Development
Yes -- No, I mean, I think that it's the case, that if we were to see, as we did with the PCSK9 that has been assessed in outcomes trials, a linear relationship has occurred with statins between LDL lowering and event rate risk and the agents are lowering LDL in the range of 30% to 35%, 40% that an oral agent that could do that as an add-on to statins would be a meaningful drug to have in our armamentarium. It's obviously not going to deliver the kind of LDL reductions you can achieve with a PCSK9 antibody, but because the drugs are oral, so we feel they play a role. What remains to be seen is whether that these agents, based on their LDL-lowering capacity, and the Merck drug will be the first that I think will answer this question more definitively, whether we see that relationship or whether we're seeing some fractional effect of that relationship and that the effect on cardiovascular risk is marginal. In which case, obviously, we'd be much less excited about pursuing this. So I think it much depends on the details of the reveal data.
是的——不,我的意思是,我認為情況是這樣的,如果我們看到,就像我們在結果試驗中評估的 PCSK9 一樣,他汀類藥物降低 LDL 與事件發生率風險之間存在線性關係,並且這些藥物能將 LDL 降低 30% 到 35%、40%,那麼一種可以作為他汀類藥物的附加療法。顯然,它無法像 PCSK9 抗體那樣降低 LDL 水平,但由於這些藥物是口服的,所以我們認為它們發揮了一定的作用。還有待觀察的是,這些藥物(基於它們降低低密度脂蛋白的能力)以及默克公司的藥物是否會成為我認為能夠更明確地回答這個問題的第一批藥物,即我們是否看到了這種關係,或者我們是否看到了這種關係的某種部分效應,而對心血管風險的影響微乎其微。在這種情況下,顯然,我們對推進這項工作的熱情就會大大降低。所以我認為這很大程度取決於公佈數據的具體細節。
Operator
Operator
Our next question comes from Umer Raffat from Evercore ISI.
我們的下一個問題來自 Evercore ISI 的 Umer Raffat。
Umer Raffat - Senior MD and Fundamental Research Analyst
Umer Raffat - Senior MD and Fundamental Research Analyst
Just to focus on the PCSK9 a bit. In the scenario where there's no meaningful inflection for Repatha, post-guideline update, would you potentially consider the idea of a pricing reset? And then also, do you think Novartis' CANTOS data impacts PCSK9 opportunity at all? Was very curious to have your take on it.
稍微重點說說PCSK9。如果指南更新後,Repatha 的價格沒有出現實質的波動,您是否會考慮重置價格?另外,您認為諾華的 CANTOS 數據會對 PCSK9 的治療機會產生任何影響嗎?非常想聽聽你的看法。
Anthony C. Hooper - EVP of Global Commercial Operations
Anthony C. Hooper - EVP of Global Commercial Operations
So Umer, this is Tony. I think a lack of inflection would be a terrible tragedy for those patients who suffer from this disease and who will either be suffering an early untimely heart attack or stroke. The price we came to market was clearly aligned with an understanding about the rebates that will be required in the marketplace to gain a competitive position. When you look at the data we presented at the ACC in March this year, we clearly talked about the pharmacoeconomic value of this product, our PCSK9 within the class and reconfirms that our net price to payers is presently very much in the range of a pharmacoeconomic price. We continue to believe that this drug brings value. When you look at the second year data that you're reducing heart attacks by 35%, reducing stroke by 24%, 27%, it is an enormous crack in this disease that takes lives on untimely basis. So we will continue to drive it forward and to ensure that the value we bring is distinct and beneficial in the marketplace.
烏默,這位是東尼。我認為,對於患有這種疾病的患者來說,缺乏語調變化將是一場可怕的悲劇,他們要么會過早地遭受心臟病發作,要么會過早中風。我們制定的市場價格顯然與我們對市場競爭所需折扣的理解相符。當你查看我們今年 3 月在 ACC 上展示的數據時,我們清楚地談到了該產品的藥物經濟學價值,我們的 PCSK9 在該類別中的地位,並再次確認我們目前向支付方支付的淨價格非常符合藥物經濟學價格的範疇。我們仍然相信這種藥物有價值。當你查看第二年的數據,你會發現心臟病發作減少了 35%,中風減少了 24% 到 27%,這說明這種疾病正在迅速改變人們的命運,避免過早死亡。因此,我們將繼續推進這項事業,並確保我們帶來的價值在市場上具有獨特性和益處。
Sean E. Harper - EVP of Research and Development
Sean E. Harper - EVP of Research and Development
And with the IL-1beta data from the Novartis trial, I think we just have to wait to see the data to understand. But I don't expect that to have a direct impact on lipid-lowering approaches.
至於諾華試驗中的 IL-1β 數據,我認為我們只需要等待數據出來才能了解情況。但我預計這不會對降血脂方法產生直接影響。
Operator
Operator
And our next question comes from Salim Syed from Mizuho Securities.
下一個問題來自瑞穗證券的Salim Syed。
Salim Qader Syed - MD, Senior Biotechnology Analyst of Equity Research & Head of Biotechnology Research
Salim Qader Syed - MD, Senior Biotechnology Analyst of Equity Research & Head of Biotechnology Research
I have one on biosimilars. So you guys have 10 now in development, I believe, and you've seen success -- with first 3, HUMIRA, Herceptin and Avastin. Can you just remind us what is your situation with manufacturing capacity? Do have capacity for all of these? Or will you need to expand and what the path there, would you have to go outside and use a CMO? Or would you build it yourself?
我有一份關於生物相似藥的資料。我相信你們現在有 10 種藥物正在研發中,而且你們已經取得了成功——前 3 種藥物分別是 HUMIRA、Herceptin 和 Avastin。能否簡單介紹一下貴公司的產能狀況?你們有能力容納所有這些嗎?或者,您是否需要擴張?如果是,您需要採取什麼途徑?您是否需要向外尋求首席行銷長(CMO)的協助?還是你會自己動手建造?
Robert A. Bradway - Chairman and CEO
Robert A. Bradway - Chairman and CEO
Salim, we're in good shape with respect to our biosimilars. Again, one of the reasons we committed to this was a growth opportunity for the company, was our belief that we do the large-scale manufacturing of proteins very well. So we're deploying our process development manufacturing skills, and we're in good shape for our programs.
薩利姆,我們的生物相似藥方面情況良好。再次強調,我們之所以致力於此,其中一個原因是它為公司帶來了發展機遇,我們相信我們非常擅長大規模生產蛋白質。因此,我們正在運用我們的製程開發製造技能,我們的專案進展順利。
Operator
Operator
Our next question comes from Alethia Young from Credit Suisse.
下一個問題來自瑞士信貸的阿萊西亞·楊。
Alethia Rene Young - Research Analyst
Alethia Rene Young - Research Analyst
Just one for Sean. Maybe if you can talk about some of the earlier things in your oncology pipeline? And how you're developing IO? And do you think you need some of the more traditional assets like PD-1 or any of the other ones (inaudible) that people are going after?
給肖恩一杯。您能否談談您腫瘤研發管線早期的一些進展?你們是如何開發IO的?你認為你需要一些更傳統的資產,例如 PD-1 或其他一些人正在追求的那些(聽不清楚)資產嗎?
Sean E. Harper - EVP of Research and Development
Sean E. Harper - EVP of Research and Development
Yes, I mean, I think, right now, we're very interested in our BiTE platform. We've made a strategic decision to focus primarily in bispecific T-cell engaging, not ADCs. And we do have a limited but important effort, of course, in collaboration with Kite on CAR T cells. The BiTE platform is moving along quite significantly and because of the timing, if you think back when we acquired the technology and how long it takes, we have a big wave of these molecules directed at hematologic and solid tumors moving into the clinic over the next 18 months or so. We have, of course, half-life extension technology that we've added to the majority of these at this point. So that is a very important, as you point out, there'll be the opportunity to combine them in many cases with checkpoint inhibition. From an R&D perspective, we've had no trouble at all getting partners to do these experiments with us providing the PD-1 and often sharing the actual cost of the trials with us. So that's not been an issue. And then the other area we're still very excited about is T-VEC, particularly now as we begin to explore hepatic injection, different tumor types in combination with checkpoint inhibition. It opens up a range of tumor types to explore, including those that don't respond well to checkpoint inhibitors without immunization strategy. And then the last one I'd mention is our CSF-1 antibody is in combination right now with Merck's PD-1. And we're very excited about that program as well. So in terms of pure immuno-oncology, those would be the ones that I'd highlight.
是的,我的意思是,我認為,目前我們對我們的 BiTE 平台非常感興趣。我們已做出策略性決定,主要專注於雙特異性 T 細胞結合,而不是抗體藥物偶聯物 (ADC)。當然,我們也在與 Kite 合作進行 CAR T 細胞的研究,這是一項有限但重要的工作。BiTE 平台進展相當順利,而且由於時機合適(想想我們收購這項技術的時間以及所需的時間),未來 18 個月左右,我們將迎來大量針對血液腫瘤和實體瘤的分子進入臨床階段。當然,我們已經將延長半衰期技術應用到大多數此類產品。正如你所指出的,這一點非常重要,在許多情況下,我們將有機會將它們與檢查點抑制結合。從研發的角度來看,我們完全沒有遇到任何困難,合作夥伴會與我們一起進行這些實驗,我們提供 PD-1,並且經常與我們分擔試驗的實際成本。所以這方面一直沒出問題。另一個我們仍然非常興奮的領域是 T-VEC,特別是現在我們開始探索肝臟注射、不同腫瘤類型與檢查點抑制劑的聯合應用。它為探索一系列腫瘤類型打開了大門,包括那些在沒有免疫策略的情況下對檢查點抑制劑反應不佳的腫瘤。最後我想提一下,我們的 CSF-1 抗體目前正在與默克公司的 PD-1 合併使用。我們也對這個項目感到非常興奮。所以,就純粹的免疫腫瘤學而言,這些就是我會重點介紹的。
Robert A. Bradway - Chairman and CEO
Robert A. Bradway - Chairman and CEO
Big picture, Alethia, is that we see a lot of excess capacity. So I think, it's 2 dozen, maybe even 25 different PD-1/PD-L1s are competing now for space in oncology. So we're unlikely to jump in, we're watching this space carefully. But looks to me like there's a lot of excess capacity right now in that area.
Alethia,從大局來看,我們看到了許多過剩產能。所以我認為,現在可能有 24 種,甚至 25 種不同的 PD-1/PD-L1 在腫瘤學領域競爭。所以我們不太可能貿然介入,我們會密切關注事態發展。但依我看,目前該領域產能過剩的情況很多。
Operator
Operator
Our next question comes from Ronny Gal from Bernstein.
我們的下一個問題來自伯恩斯坦公司的羅尼·加爾。
Aaron Gal - Senior Research Analyst
Aaron Gal - Senior Research Analyst
Just a question on 340B program, we're talking to folks in the hospital channels, they're talking about expanding their outpatient services out of this portion of shared hospitals. Could you just comment about how big this is for your business? What do you see the trend line? And what do you expect the impact would be of the CMS proposal to reduce the reimbursement rate?
關於 340B 計劃,我們想問一個問題。我們正在與醫院管道的人員交談,他們正在討論將門診服務擴展到共享醫院的這一部分。您能否談談這件事對貴公司有多重要?你看到的趨勢線是什麼?您認為CMS降低報銷率的提議會產生什麼影響?
Anthony C. Hooper - EVP of Global Commercial Operations
Anthony C. Hooper - EVP of Global Commercial Operations
Ronny, it's Tony. I don't have those exact numbers with me. We can get back to you. But obviously, a lot of our oncology business is in the institution which falls under 340B, and we watch that business carefully. It has grown quite dramatically in the last 3, 4 years or so. But I think it's sort of under 20% of our total business would be 340B.
羅尼,我是東尼。我手頭上沒有確切的數字。我們會盡快回覆您。但很顯然,我們的許多腫瘤業務都在 340B 計畫涵蓋的機構內,我們會密切關注這項業務。在過去三、四年裡,它的發展非常迅速。但我認為這大約占我們總業務的不到 20%,也就是 3,400 億美元。
Robert A. Bradway - Chairman and CEO
Robert A. Bradway - Chairman and CEO
Closer to 10% of the business, Ronny. And the trade associations, as you know, bio and pharma have been very focused on this. I think as the program that got launched with noble intentions but it's one that's subject to some abuse. And so there's, as you know, some oversight focus in this area right now on Capitol Hill, including looking at -- whether the discounts are being appropriately applied to the patients that are most in need of them, et cetera. So I'd say stay tuned. This is an area that is likely to be evolving here over the coming legislative calendar.
羅尼,差不多占公司總業務的10%。如您所知,生物製藥行業協會一直非常關注這一點。我認為這個計畫雖然出於好意而啟動,但卻遭到了一些濫用。因此,如您所知,目前國會山莊對這一領域進行了一些監督,包括審查折扣是否適當地應用於最需要折扣的患者等等。所以,敬請期待。在接下來的立法議程中,這一領域可能會發生變化。
Operator
Operator
Our next question comes from Jim Birchenough from Wells Fargo Securities LLC.
下一個問題來自富國證券有限責任公司的吉姆·伯奇諾夫。
James William Birchenough - MD and Senior Biotechnology Analyst
James William Birchenough - MD and Senior Biotechnology Analyst
You've mentioned value-based pricing a few times with regards to the CGRP category and Repatha. Could you maybe talk about what you're hearing from payers in terms of how set up they are for that kind of model? And in migraine specifically, could you see some sort of contracts that are based on a certain level of migraine reduction?
您曾多次提到基於價值的定價,尤其是在 CGRP 類別和 Repatha 方面。您能否談談您從支付方那裡了解到的情況,以及他們對這種模式的適應程度?具體到偏頭痛領域,能否制定一些基於偏頭痛緩解程度的合約?
Anthony C. Hooper - EVP of Global Commercial Operations
Anthony C. Hooper - EVP of Global Commercial Operations
So Jim, the value-based process is defining the value of a product based on the threshold you set for quality of life you save. It's a process used by most health technology assessment countries around the world such as the U.K., Canada and Australia. It's an evolution of a process in the U.S. at the moment. And we feel quite robust and confident in our ability to establish that type of range of value for a product. We discussed that with the payers on an ongoing basis. I think what you might be referring to is a bit of our risk-share contract we've actually put in place and those are interesting ones, too. We have product that deliver a distinctive value and we prepare to put our money where our mouth is with those particular products. Some payers have taken those up such as Harvard Pilgrim. Others are trying to work at how do they track that, monitor that, as they go forward. But I would imagine going forward, it has to be something that becomes more and more popular.
所以吉姆,基於價值的流程是根據你設定的拯救生活品質的門檻來定義產品的價值。這是世界上大多數衛生技術評估國家(如英國、加拿大和澳洲)所採用的流程。這是美國目前正在經歷的發展過程。我們對自己為產品建立這種價值範圍的能力感到非常有信心。我們與付款方持續討論過這個問題。我想你可能指的是我們已經實施的風險分擔合約的一部分,這些也很有趣。我們擁有具有獨特價值的產品,我們準備好用實際行動來證明這些產品的品質。一些付費者已經接受了這些,例如哈佛朝聖者協會。其他人則在努力研究如何追蹤、監控這些情況,以便更好地推進工作。但我認為,展望未來,它一定會變得越來越受歡迎。
Operator
Operator
Our next to last question comes from Andrew Peters from Deutsche Bank.
倒數第二個問題來自德意志銀行的安德魯彼得斯。
Andrew Ross Peters - Director
Andrew Ross Peters - Director
Quick one from me. Just wanted to see if you've seen an inflection in the rate of Repatha rejections or approvals since FOURIER? And do you think that's really the biggest driver of kind of the share increases that you've seen against alirocumab? Or is it something else that you see in the market?
我來簡單說一下。只是想了解一下,自從 FOURIER 事件以來,您是否觀察到 Repatha 的拒簽率或批准率發生了變化?你認為這真的是導致阿利西尤單抗市佔率成長的最大驅動因素嗎?或者,您在市場上看到了其他的東西?
Anthony C. Hooper - EVP of Global Commercial Operations
Anthony C. Hooper - EVP of Global Commercial Operations
If you could turn to Page 23 of your slide deck, that's, of course, the chart I look at often, which shows a distinctive movement of our market share since the outcomes data were delivered at the ACC in March. Clearly, people understanding the value of this drug in terms of long-term treatment. So we have, in the interim also worked hard, as I said earlier, to try and reduce the impact on patients who have large commercial copays or large commercial deductions. And we're working consistently with payers to try and make the utilization management criteria as well as the process to get access to drug more reasonable to ensure appropriate patients get access.
如果您能翻到投影片的第 23 頁,那當然是我經常查看的圖表,它顯示了自 3 月在 ACC 會議上公佈結果數據以來,我們的市場份額發生了明顯的變化。顯然,人們已經認識到這種藥物在長期治療方面的價值。因此,正如我之前所說,在此期間,我們也努力減少對有大額商業自付額或大額商業扣除額的患者的影響。我們一直在與支付方合作,努力使藥物利用管理標準以及取得藥物的流程更加合理,以確保合適的患者能夠獲得藥物。
Operator
Operator
And our final question comes from Carter Gould from UBS Equities.
最後一個問題來自瑞銀股票部的卡特‧古爾德。
Carter Lewis Gould - Large Cap Biotech Analyst
Carter Lewis Gould - Large Cap Biotech Analyst
For Tony, maybe just taking a different direction, can you help frame for us the magnitude of the incremental commercial opportunity for moving XGEVA into myeloma? And any nuances we should keep in mind in looking at the peak penetration in the U.S. versus Europe?
對 Tony 來說,或許可以換個角度來看,您能否幫我們分析一下將 XGEVA 推向多發性骨髓瘤領域所帶來的巨大商業機會?在比較美國和歐洲的市場滲透率高峰時,我們應該注意哪些細微差別?
Anthony C. Hooper - EVP of Global Commercial Operations
Anthony C. Hooper - EVP of Global Commercial Operations
You guys can see the size of the multiple myeloma market based on the patient numbers themselves. So there's a distinctive population that exists over there. It's a population that presently isn't in our label, and therefore, we have not been able to promote on that particular patient group. And we look forward doing it early in or whenever we get another label in 2018.
你們可以從患者數量本身看出多發性骨髓瘤市場的規模。所以那裡存在著一個獨特的人群。目前,該族群不在我們的產品標籤範圍內,因此,我們無法針對該特定患者群體進行推廣。我們期待在 2018 年初或一旦我們找到新的唱片公司就去做這件事。
Robert A. Bradway - Chairman and CEO
Robert A. Bradway - Chairman and CEO
February PDUFA date. And Sean, you might just want to remind Andrew and others of the benefits we believe that XGEVA will provide those patients with multiple myeloma.
二月份的PDUFA日期。肖恩,你或許應該提醒安德魯和其他人,我們相信 XGEVA 將為多發性骨髓瘤患者帶來哪些好處。
Sean E. Harper - EVP of Research and Development
Sean E. Harper - EVP of Research and Development
Yes, I mean, as you probably are aware, virtually all myeloma patients, because of the secreted protein that characterizes the disease filters into the kidney have varying degrees of renal insufficiency and have to have dose reductions or simply can't tolerate drugs like zoledronic acids. So there is an obvious need for a product that doesn't have renal clearance such as denosumab. However, in our original applications with denosumab, we had a subgroup of patients in one of the trials of multiple myeloma where it appeared as though there could be a harm signal on overall survival. It was a subgroup analysis. It was unlikely to be real. We've, of course, demonstrated it wasn't real by doing this large trial that we've filed. And once we have the indication, we can promote it and so on, I think the utilization that's been hampered by that concern about impact on the actual disease process will be alleviated, and there, it should be a great advance for patients with multiple myeloma to have more access to denosumab.
是的,我的意思是,您可能也知道,幾乎所有多發性骨髓瘤患者,由於該疾病的特徵是分泌的蛋白質會濾入腎臟,因此都會出現不同程度的腎功能不全,不得不減少劑量,或者根本無法耐受唑來膦酸等藥物。因此,顯然需要一種無需腎臟清除的產品,例如地諾單抗。然而,在我們最初使用地諾單抗治療多發性骨髓瘤的試驗中,我們發現部分患者在總存活期似乎有有害訊號。這是一項亞組分析。這不太可能是真的。當然,我們已經透過提起這場大規模訴訟證明了這不是真的。一旦我們有了適應症,我們就可以推廣它等等,我認為,由於擔心對實際疾病進程的影響而阻礙其使用的現象將會得到緩解,對於多發性骨髓瘤患者來說,能夠更多地獲得地諾單抗應該是一項巨大的進步。
Robert A. Bradway - Chairman and CEO
Robert A. Bradway - Chairman and CEO
Okay. Carter, thanks for that question. Thank you all for joining the call. And I also want to thank our worldwide staff who are busy successfully executing on our strategy and operating the business right now really effectively, while both delivering for patients and shareholders. So I hope you can see from our results that we're positioned for the changing competitive environment with the benefit of a new product cycle set to drive volume growth and a strong balance sheet that we intend to deploy to create value for our shareholders. We see both of these as key to sustaining long-term growth with Amgen. So thanks very much for joining us. We look forward to talking to you after the third quarter.
好的。卡特,謝謝你的提問。感謝各位參與通話。我還要感謝我們遍佈全球的員工,他們正忙於成功執行我們的策略,並有效率地經營業務,同時為病患和股東創造價值。因此,我希望大家能從我們的業績中看出,我們已經為不斷變化的競爭環境做好了準備,新的產品週期將推動銷量成長,我們擁有強勁的資產負債表,我們打算利用這些優勢為股東創造價值。我們認為這兩點對於安進公司維持長期成長至關重要。非常感謝您的參與。我們期待在第三季結束後與您交流。
Arvind Sood - VP of IR
Arvind Sood - VP of IR
Thanks, everybody, appreciate your participation and look forward to connecting both offline and after hours. Thanks, again.
謝謝大家,謝謝你們的參與,期待在線下和課後與大家交流。再次感謝。
Operator
Operator
Ladies and gentlemen, this concludes Amgen's Second Quarter 2017 Financial Results Conference Call. You may now disconnect.
女士們、先生們,安進公司2017年第二季財務業績電話會議到此結束。您現在可以斷開連線了。