AbbVie Inc.(ABBV) 管理层出席高盛全球医疗保健会议 (成绩单)

[机器翻译] 电话会议 · 2019年06月13日 · 79 次阅读

AbbVie Inc. (NYSE:ABBV) Goldman Sachs Global Healthcare Conference June 12, 2019 11:00 AM ET

AbbVie Inc.(纽约证券交易所股票代码:[ABBV])高盛全球医疗保健会议2019年6月12日美国东部时间上午11:00

公司参与者

Mike Severino - Vice Chairman & President
Rob Michael - Senior Vice President & CFO

  • Mike Severino - 副主席兼总裁
  • Rob Michael - 高级副总裁兼首席财务官

电话会议参与者

Terence C. Flynn - Goldman Sachs

  • Terence C. Flynn - 高盛

Terence C. Flynn

I think we're going to get started. Good morning, everybody. Thanks for joining us. Terence C. Flynn, the biopharma analyst here at Goldman Sachs. We are very pleased to have AbbVie with us this morning. Joining us from their Company, we have Mike Severino, Vice Chairman and President; and Rob Michael, Senior Vice President and CFO. Thanks very much for joining us.
Now before we get started, I’ve to read the disclaimer. We are required to make certain disclosures in public appearances about Goldman Sachs' relationships with companies that we discuss. These disclosures relate to investment banking relationships, compensation received or 1% or more ownership. We are prepared to read aloud disclosures for any issuer upon request. However, these disclosures are available in our most recent reports available to U.S. clients on our firm portals. Disclosures and updates to these disclosures are also available by ticker on the firm's public website at www.gs.com. Also the view stated by non-Goldman Sachs personnel do not necessarily reflect those of Goldman Sachs.
Great. Well with that out of the way, let's get started. Maybe just, first, would love to get your perspective on your progress on delivering on your long-range plan. I know it's something you guys have been highly focused on, but would just love to get an update there to start off and then have a number of other questions.

我想我们要开始了。大家早上好。感谢您加入我们。高盛(Goldman Sachs)生物制药分析师Terence C. Flynn。我们很高兴今天早上让AbbVie和我们在一起。加入我们公司,我们有Mike Severino,副主席兼总裁

Mike Severino

Okay. So, I would be happy to do that. When we look at our progress against our long-range plan and the state of our business, we’re very pleased with the progress we are making. Our on-market products have performed very, very well. So HUMIRA, IMBRUVICA, MAVYRET and others have performed in a very, very strong fashion and that has allowed us to drive double-digit earnings growth, including double-digit earnings growth this year in a year when we experience direct biosimilar competition outside of the U.S.
So we're hitting our marks there, and we feel good about the progress we are making. We’ve also had very strong performance from our pipeline. And that has allowed us to identify a group of core products that are either recently launched or in late stage development that can continue to drive that growth into the future. And that would include our hematology, oncology franchise with IMBRUVICA and VENCLEXTA that we expect to deliver $5.1 billion from revenue this year and growing at a very robust rate. That includes our next-generation immunology assets. So risankizumab obviously now in launch mode and with upadacitinib, which is approaching approval decisions towards the second half of this year. So that gives us a very, very strong next-generation position in the immunology market, which is an important market. It's a large market, it's a market that’s growing, it's a market where we've been leaders, and so it allows us to maintain that position. So we feel good about that progress.
And then we’ve assets like ORILISSA that contribute very meaningfully to our long-range plan as well. We expect ORILISSA to contribute $2 billion in the outyears to that plan, so we feel very good about the progress that we are making.

好的。所以,我很乐意这样做。当我们根据我们的长期计划和业务状况来看待我们的进展时,我们对我们取得的进展感到非常满意。我们的市场产品表现非常,非常好。因此,HUMIRA,IMBRUVICA,MAVYRET和其他人以非常非常强大的方式表现,这使我们能够实现两位数的盈利增长,包括今年我们在该领域之外进行直接生物仿制药竞争时的两位数收益增长。我们

所以我们在那里打上了我们的标记,我们对我们取得的进展感到满意。我们的管道也有非常强劲的表现。这使我们能够确定一组最近推出或后期开发的核心产品,这些产品可以继续推动未来的增长。这将包括我们的血液学,IMBRUVICA和VENCLEXTA的肿瘤学特许经营权,我们预计今年将从收入中提供51亿美元,并以非常强劲的速度增长。这包括我们的下一代免疫学资产。所以risankizumab显然现在处于发射模式,而upadacitinib正在接近今年下半年的批准决定。因此,这为我们在免疫学市场提供了非常非常强大的下一代定位,这是一个重要的市场。这是一个巨大的市场,它是一个正在成长的市场,它是一个我们一直是领导者的市场,因此它使我们能够保持这一地位。所以我们对这一进展感到满意。

然后我们像ORILISSA这样的资产也为我们的长期计划做出了非常有意义的贡献。我们预计ORILISSA将在该计划的外部捐款20亿美元,因此我们对我们正在取得的进展感到非常满意。

Terence C. Flynn

Great. Maybe help us think about the operating margins, near-term, longer-term, I know that’s been a focus of investors. Are you on track for heading your 2020 goal?

非常好。 也许可以帮助我们考虑经营利润,近期,长期,我知道这一直是投资者关注的焦点。 您是否正在走向2020年的目标?

Mike Severino

Yes, Terence, if you look at our first quarter, we just printed a 48% profile. We’ve guided a full-year of 47%. Keep in mind that’s 200 basis point improvement in the year of flat sales and new product launch expense. So if you look at our track record as a company, look at last year, 250 basis point improvement, largely coming from P&L leverage as a sale -- sales [indiscernible] expenses. If you go back to conception of AbbVie, we’ve grown that profile by over 800 basis points. So as you think about overall sales growth, the new products ramping, in 2020 you expect to see P&L leverage again.

是的,特伦斯,如果你看看我们的第一季度,我们只打印了48%的个人资料。 我们指导了47%的全年。 请记住,在销售额和新产品发布费用的一年中,200个基点的改进。 因此,如果你看一下我们作为一家公司的业绩记录,那么去年看,250个基点的改善,主要来自P&L杠杆作为销售 - 销售[音频不清晰]费用。 如果你回到AbbVie的概念,我们已经增加了超过800个基点。 因此,当您考虑整体销售增长时,新产品将在2020年出现,您希望再次看到损益。

Terence C. Flynn

Yes, and then how about as you think longer term with that kind of mix shift changing? I know that’s another question recognizing, but I don’t want to give direct guidance, but how do you think about kind of the puts and takes in the longer term?

是的,然后你认为这种混合变化的长期变化怎么样? 我知道这是另一个承认的问题,但我不想给出直接的指导,但是你如何看待这种看跌期权并从长远来看呢?

Mike Severino

When you look at the strength of our pipeline and our expectations for overall topline growth. And again, I would think about P&L leverage to be a key thing we’ve been able to establish. I would -- certainly, there will be mixed considerations within the products, but overall topline growth P&L leverage should be part of our story.

当你看到我们的管道的力量和我们对整体增长的期望。 而且,我认为P&L杠杆是我们能够建立的关键因素。 我当然会在产品中考虑各种因素,但总体增长P&L杠杆应该成为我们故事的一部分。

Terence C. Flynn

Okay. One of the other big picture questions, obviously, has been there have been a number of proposed changes to drug pricing in the U.S. Obviously, hard to know where all this falls, but would love your perspective on some of the proposals out there, specifically, as it relates to maybe the Part D side. And then would you expect the U.S to move away from a rebate system? And then if that does happen, maybe help us think about if you guys adapt your business model at all or you feel like you’re kind of in good position already given those changes that could occur?

好的。 显然,其他一个重要的问题是,美国的药品定价有很多提议的改变显然,很难知道这一切在哪里下降,但是会非常喜欢你对某些提案的看法,特别是 ,因为它可能与D部分有关。 那么你会期望美国脱离退税制度吗? 然后,如果确实发生了这种情况,也许可以帮助我们思考一下你们是否适应了你们的商业模式,或者你觉得你们已经处于有利地位,并且已经发生了可能发生的变化?

Mike Severino

Yes. So as you say it's hard to know exactly where this is all going to end right now, and there have been a number of proposals that have been put on the table. Sometimes that have been fits and starts with the proposal seems like something is imminent, then it takes a little bit longer for things to come forward. We don’t know exactly where things are going to land. But when we look at the landscape, I think the most advanced proposals are around rebate rule and Medicare Part D. And it's our expectation that something will get done, hopefully, later on this year around that. And I think at the core of that we're supportive of ideas that reduce out-of-pocket costs for seniors and Medicare Part D. So that’s certainly something that we can get behind as a company. We think seniors on Medicare Part D bear a large burden and in some ways an unfair burden of the costs compared to patients receive their care in other settings paid for by other payers. And so that part of the proposal we think is very good. When we look at the whole proposal as we understand it today, we don’t see it affecting our business. So the basic principle is that rebates will be replaced by upfront discounts and that patients would benefit from those discounts by having reduced copays at the point-of-sale. And again, that part of the proposal I think is very aligned with our view as a company. And when we look at our ability to compete in that system, we feel very good about it. We’ve competed in healthcare systems around the world, including international systems where there are no rebates, where formularies are completely open and formularies for the U.S are becoming more open over the past years, and we’ve shown that we compete very effectively in those settings.

是。因此,正如你所说,现在很难确切知道这一切将在何时结束,而且已经提出了许多提案。有时候这个提议似乎已经适应并且开始似乎是迫在眉睫的事情,那么事情的发展需要更长的时间。我们不确切知道将要降落的地方。但是,当我们观察景观时,我认为最先进的建议是围绕回扣规则和医疗保险D部分。我们期望有一些事情能够在今年晚些时候完成。而且我认为我们的核心是支持减少老年人和医疗保险D部分的自付费用的想法。所以这肯定是我们可以作为一家公司落后的事情。我们认为医疗保险D部分的老年人承担了很大的负担,并且在某些方面,与患者在其他付款人支付的其他环境中接受护理相比,成本不公平。因此,我们认为该提案的一部分非常好。当我们今天了解整个提案时,我们认为它不会影响我们的业务。因此,基本原则是折扣将被前期折扣取代,并且患者将通过减少销售点的自付额来从这些折扣中受益。而且,我认为该提案的那部分与我们作为公司的观点非常一致。当我们看到我们在该系统中竞争的能力时,我们感觉非常好。我们参与了全球医疗系统的竞争,包括没有折扣的国际体系,处方集完全开放,美国的处方集在过去几年变得更加开放,我们已经证明我们在那些设置。

Terence C. Flynn

Okay. And how about the -- would you expect that the Part D changes would flow through the commercial side? Is that your expectation or do you think that would take longer to play out, maybe over what timeframe?

好的。 怎么样 - 你会期望D部分的变化会流经商业方面吗? 这是你的期望,还是你认为这需要更长的时间才能完成,也许是在什么时间范围内?

Mike Severino

Yes. Again, I think a lot remains to be seen. But I think most people believe and I think we believe that will over time, but it will probably take a little bit longer than on Medicare Part D side.

是。 同样,我认为还有很多事要看。 但我认为大多数人都相信,而且我认为我们会相信这会随着时间的推移,但它可能需要比医疗保险D部分更长的时间。

Terence C. Flynn

Okay, got it. You mentioned besides the immunology market, I mean, talked about your long-range plan. I mean, you guys are projecting to grow to $90 billion in 2025. I think J&J has projected $80 billion in 2023, about $67 billion last year. As we think about kind of -- I think penetration biologics in the RA space fairly high, look at psoriasis on the lower end, maybe IBD in median between, but do you think that IBD and psoriasis can really approach RA over the longer-term? What can you guys do to really move the needle on that front as we think about kind of the forward growth of the immunology market.

好,知道了。 你提到除了免疫学市场,我的意思是,谈到你的远程计划。 我的意思是,你们预计到2025年将增长到900亿美元。我认为强生公司预计2023年将达到800亿美元,去年约为670亿美元。 正如我们想到的那样 - 我认为RA空间中的渗透生物制剂相当高,看看低端的牛皮癣,也许中间的IBD,但你认为IBD和牛皮癣能够长期接近RA吗?? 当我们考虑免疫学市场的前瞻性增长时,你们能做些什么才能真正在这方面发挥作用。

Mike Severino

Well as you say, it's a large and growing market. Across those three segments, the numbers that you quoted match our understanding of the markets as well. Something like approximately $90 billion in the 2025 timeframe. If you look at penetration right now in rheumatology, it's about 40%. And that’s been growing steadily over the years and we see continued growth there. If you look at the gastroenterology segment, it's a little bit below that, but also growing. So overall gastroenterology is probably about 30%, little bit higher on Crohn's, a little bit lower on UC, but both growing and we see continued growth there. Psoriasis has had the lowest penetration. It's about 10% right now, but that's grown substantially from low single digits up to the 10%. And so we do see room for considerable growth in bio penetration in psoriasis. We don't necessarily see it getting up to that 40% range where RA is, but we do see room for substantial growth.

正如你所说,这是一个庞大且不断增长的市场。 在这三个细分市场中,您引用的数字也符合我们对市场的理解。 在2025年的时间框架中大约有900亿美元。 如果你现在看一下风湿病学的渗透率,它大概是40%。 这些年来一直在稳步增长,我们看到那里的持续增长。 如果你看一下胃肠病学部分,它会略低于此,但也会增长。 因此整体胃肠病学可能约为30%,克罗恩病患者略高一点,而UC则略低,但两者都在增长,我们看到那里的持续增长。 牛皮癣的渗透率最低。 它现在约为10%,但从低个位数到10%大幅增长。 因此,我们确实看到银屑病生物渗透率有相当大的增长空间。 我们不一定看到RA达到40%的范围,但我们确实看到了大幅增长的空间。

Terence C. Flynn

Okay. And is that really going to be driven by the new targeted drugs? Is that going to be what’s driving that, or is it going to be physician education? Like what’s going to be kind of the key catalyst that’s going to drive that?

好的。 这真的是由新的靶向药物驱动的吗? 这会是什么推动,或者它将成为医生教育? 就像什么是推动它的关键催化剂?

Mike Severino

Well, it's really both. I mean, I think over time people are recognizing the benefits of treating psoriasis with biologic agents to sort of results that can be achieved, that obviously is complemented by newer agents, higher efficacy agents, agents that provide real advantages, and so I think it's both time, physicians becoming more comfortable in that space using biologics where they hadn't used them before, and also the availability of newer and better agents, I think both components will drive that growth.

嗯,这两者都是。 我的意思是,我认为随着时间的推移,人们认识到用生物制剂治疗牛皮癣的好处可以达到可以实现的结果,显然可以通过新药,更高效的药剂,提供真正优势的药剂来补充,所以我认为它是 无论是时间,医生使用生物制剂在以前没有使用它们的地方变得更加舒适,而且还有更新和更好的药剂的可用性,我认为这两个组成部分将推动这种增长。

Terence C. Flynn

Okay. Maybe moving on, you mentioned your upcoming new product cycles in immunology, congratulations on the approval of SKYRIZI. I know it was an important one for you guys. Maybe we will focus there before we move on to upadacitinib. But first we just love an update on how the launch is going and maybe just to start you could just remind us about the differentiated profile, like what are the key aspects that you guys really want to highlight? And then, what -- how are you leveraging those in the commercial side?

好的。 也许还在继续,你提到了即将到来的免疫学新产品周期,祝贺SKYRIZI获得批准。 我知道这对你们来说很重要。 在我们继续使用upadacitinib之前,我们可能会关注那里。 但首先我们只是喜欢关于发布方式的更新,也许只是为了开始你可以只提醒我们有关差异化的配置文件,比如你们想要强调的关键方面是什么? 然后,你是如何利用商业方面的?

Mike Severino

Sure. So when we set out to develop a number of next-generation immunology assets, our goal in each of the conditions where HUMIRA is active is to find a therapy that raise the bar on standard of care. And we’re doing that across each of the major areas, but if you look at psoriasis and SKYRIZI, I think it clearly heads that market in two ways. One, by driving response at a higher level that can be achieved with HUMIRA or with other agents that are available today. And also by delivering response to patients who have failed other therapies. And within our clinical program, we demonstrated both of those quite effectively in terms of the level of complete skin clearance or PASI 100 response level. The fact that those responses were very robust, not only in patients who are naïve to biologics, but in patients who have been pretreated and failed other biologics. And we also demonstrated very durable response, which in psoriasis, in particular, is very important. So there's a perception amongst patients and physicians that many agents that are used today lose efficacy over time. And SKYRIZI has very, very strong response not only at the primary endpoint clinical trials at 12 to 16 weeks, but also at a year. And then we very recently presented a 2-year data that shows that those responses are still being maintained and they're still very robust efficacy. So when you look at that whole profile and then you couple it with the strong benefit risk, and quarterly administration for maintenance, which is an important feature as well. We think we really hit the market in terms of the product profile there.

当然。因此,当我们开始开发大量下一代免疫学资产时,我们在HUMIRA活跃的每个条件下的目标是找到一种提高标准治疗标准的治疗方法。我们在每个主要领域都这样做,但如果你看看牛皮癣和SKYRIZI,我认为它在两个方面明显领先于这个市场。第一,通过使用HUMIRA或现有的其他代理商实现更高水平的响应。并且还通过对未能通过其他疗法治疗的患者做出反应。在我们的临床计划中,我们在完全皮肤清除水平或PASI 100反应水平方面非常有效地证明了这两者。事实上,这些反应非常强大,不仅适用于对生物制剂天真的患者,而且适用于经过预处理且未通过其他生物制剂治疗的患者。而且我们也表现出非常持久的反应,特别是在牛皮癣中非常重要。因此,患者和医生都认为,如今使用的许多药物会随着时间的推移而失效。 SKYRIZI不仅在12至16周的主要终点临床试验中,而且在一年内都有非常强烈的反应。然后我们最近提供了一份2年的数据,显示这些反应仍在维持,并且它们仍然具有非常强大的功效。因此,当您查看整个配置文件然后将其与强大的福利风险以及季度管理维护相结合时,这也是一个重要特征。我们认为我们在那里的产品概况确实打入了市场。

Terence C. Flynn

Okay. And maybe I know you guys have laid out this metric by I think end July at 50% access. Maybe how are you tracking towards that, and again we're seeing the script starts -- start to come through, anything can tell us about kind of patient mix, access where things stand right now and what you’re seeing? Is this all kind of naive patients coming on the therapy, are these patients that have failed other drugs.

好的。 也许我知道你们已经制定了这个指标,我认为7月底达到了50%。 也许你是如何追踪这一点的,我们再次看到脚本开始 - 开始通过,任何东西都可以告诉我们关于患者组合的类型,访问现在的情况以及你所看到的内容? 这是所有接受治疗的天真患者,这些患者是否已经失败了其他药物。

Mike Severino

So we’ve said that we expect to have 50% commercial access within about three months of launch. That’s by the end of July, and we’re tracking well against that Mark, okay?

所以我们已经说过,我们希望在推出后大约三个月内有50%的商业访问权限。 那是在7月底之前,我们正在跟踪那个马克,好吗?

Terence C. Flynn

Okay.

好的。

Mike Severino

Maybe also said we expect HUMIRA like access, a very broad-based access by the end of the year. And again we're tracking well against that metric as well. Early feedback from the field is very positive. Physician reception and interest is very positive. Patient reception, patient feedback is very positive. So we would say that the launch is going very much in line with our expectations.

也许还说我们希望HUMIRA能够获得访问权限,这是一种非常广泛的访问方式。 同样,我们也很好地跟踪该指标。 该领域的早期反馈非常积极。 医生的接待和兴趣非常积极。 患者接待,患者反馈非常积极。 所以我们会说发布会非常符合我们的预期。

Terence C. Flynn

And I think -- you think about the mix. In the early stages, I would expect to see more second line plus, but as physicians get more experience, we absolutely feel that SKYRIZI has an important place in the first-line of setting as well.

而且我认为 - 你考虑的是混合。 在早期阶段,我希望看到更多的二线加,但随着医生获得更多的经验,我们绝对认为SKYRIZI在第一线设置中也占有重要地位。

Terence C. Flynn

Okay. And can you guys give us any details about where access is in terms of tiering? So where this has been positioned right now on the plans or what are you aiming for when you’re thinking about where the tier that’s relative to your portfolio?

好的。 您能否向我们提供有关分层访问权限的详细信息? 那么,当您考虑到与您的投资组合相关的等级所在的位置时,现在该计划的位置是什么?或者您的目标是什么?

Mike Severino

So when we say 50% access, we mean access at a parity to HUMIRA and other biologics. So upfront access for the biologics space.

因此,当我们说50%访问时,我们的意思是访问HUMIRA和其他生物制剂。 因此,生物制剂领域的前期访问。

Terence C. Flynn

Okay, great. As we think about, I guess upadacitinib moving on here, maybe again similar question to SKYRIZI, just recap the profile for us what’s most exciting about this? And then how it is compared to some of the other JAKs that are available or either in development and really what's the differentiated feature that you see on the upadacitinib front?

好,太棒了。 正如我们想到的那样,我想upadacitinib继续前进,也许再次向SKYRIZI提出类似的问题,只是回顾一下我们对此最令人兴奋的情况? 然后将它与其他一些可用或正在开发的JAK进行比较,以及您在upadacitinib前端看到的差异化功能是什么?

Mike Severino

Well if you are -- turning back to what we said about our strategy of finding an agent that either drives higher levels of response or drives response in patients who have failed of other therapies in RA, we feel that upadacitinib fits that bill very nicely. If you look at performance across our Phase 3 clinical trial program, we uniformly drove very high levels of response. Not just at the ACR20 level, but at much higher levels of response, at ACR50, ACR70, patients who achieved DAS low disease activity or remission, which we believe really should be the standard going forward. Now that there are agents that can drive that level of response, there's really no reason to leave the patient with disease activity that's greater than that. And so we did that across a wide range of settings. We did that very early patients who are new to therapy. We did that in classic methotrexate inadequate responder populations. And we also drove those responses in patients who have failed multiple biologic therapies, not just TNF-inadequate responders, but true biologic inadequate responders. So really across the spectrum we are driving the level of response that we wanted to try. We had a very, very strong benefit on structural endpoints in two different studies, a very strong monotherapy data, so really has rounded out the efficacy profile. And then lastly and I think very importantly, we had very, very strong head-to-head data against HUMIRA, which is of course the gold standard today in that space, where we showed superiority to HUMIRA across every endpoint that was tested. And that sort of broad-based very robust deal, I think is an important demonstration of the profile.

好吧,如果你 - 回到我们所说的关于寻找一种能够驱动更高水平的反应或驱动RA患者其他疗法失败的患者反应的药剂的策略,我们觉得upadacitinib非常适合这项法案。如果你看看我们的第3阶段临床试验计划的表现,我们统一推动了非常高水平的反应。不仅在ACR20水平,而且在更高水平的反应,ACR50,ACR70,达到DAS低疾病活动或缓解的患者,我们认为这应该是未来的标准。既然有代理人可以推动这种程度的反应,那么实际上没有理由让病人远离疾病活动。因此我们在各种环境中都做到了这一点。我们做了那些刚接触治疗的早期患者。我们在经典甲氨蝶呤不足的应答者群体中做到了这一点。我们还对那些多种生物疗法失败的患者提出了这些反应,不仅仅是TNF不足的反应者,而且是真正的生物学反应不足者。因此,我们正在推动我们想要尝试的响应水平。在两项不同的研究中,我们在结构终点上获得了非常非常强大的益处,这是一种非常强大的单药治疗数据,因此确实完善了疗效。最后,我认为非常重要的是,我们有非常非常强大的针对HUMIRA的正面数据,这当然是当今该领域的黄金标准,我们在测试的每个端点都显示出对HUMIRA的优势。我认为这种广泛的非常强大的交易是该概况的重要证明。

Terence C. Flynn

Do you think -- I mean, I think that’s one of the questions. Do you think you'll be able to get that head-to-head data on the label that had versus HUMIRA?

你认为 - 我的意思是,我认为这是其中一个问题。 你认为你能够在与HUMIRA相比的标签上获得那些头对头的数据吗?

Mike Severino

Well, typically it takes two head-to-head studies to get a label claim. So it's not necessarily so much about what's in the label.

嗯,通常需要两次头对头的研究来获得标签声明。 因此,标签中的内容并不一定如此。

Terence C. Flynn

Okay.

好的。

Mike Severino

It's about the overall profile of the molecule that's broadly presented, I think well understood by the [indiscernible] in a number of settings. They can be used with payers, they can be used in a number of different interactions by different groups. And so it's more about demonstrating the overall profile than about getting a specific claim in the label.

这是关于广泛呈现的分子的整体概况,我认为在许多情况下[音频不清晰]很好理解。 它们可以与付款人一起使用,它们可以被不同的群体用于许多不同的互动中。 因此,除了在标签中获得特定声明之外,更多的是展示整体资料。

Terence C. Flynn

Okay. Would you consider running a second study though to get that label claim? Because to me, it could be a key advantage relatively to some of the other competitors coming and maybe in a world where we do have HUMIRA biosimilars out there, does that give you increased leverage in terms of position, or do you think having just the one study in, again being able to talk as we did, kind of gives you enough leverage on that front?

好的。 您是否会考虑进行第二项研究以获得该标签声明? 因为对我而言,相对于其他一些竞争对手来说,这可能是一个关键的优势,也许在我们确实拥有HUMIRA生物仿制药的世界里,这是否会增加你在职位方面的影响力,或者你认为只有 一项研究,再次像我们一样能够说话,有点在这方面给你足够的影响力?

Mike Severino

We believe the label have everything that it needs to make us competitive. So we are always committed to ongoing data generation. We will be generating data on all of our products for many years to come. And so, we will do more work with upadacitinib, but we feel very good about what we would expect to be in the initial label and it will have all the information we need. You asked about positioning against other agents. If you look at the program we run with the only JAK inhibitor that’s at the primary endpoint across every study, we are the only JAK inhibitor that shown the kind of head-to-head superiority against HUMIRA that we’re talking about. So we feel that we are going to have the data that we need to be competitive.

我们相信该品牌拥有使我们具有竞争力所需的一切。 因此,我们始终致力于持续的数据生成。 我们将在未来许多年内生成所有产品的数据。 因此,我们将使用upadacitinib做更多工作,但我们对初始标签中我们期望的内容感到非常满意,并且它将拥有我们需要的所有信息。 您询问了与其他代理商的定位。 如果你看一下我们使用唯一的JAK抑制剂运行的程序,它是每个研究的主要终点,我们是唯一的JAK抑制剂,它显示了我们所讨论的对抗HUMIRA的那种头对头优势。 因此,我们认为我们将拥有竞争所需的数据。

Terence C. Flynn

Okay. One other question. I know you guys have gotten is just a potential for an FDA AdCom and then kind of corollary to that is how to think about the label and does the FDA view this as kind of class labeling or do you guys think you can kind of carve out a differentiated label versus some of the other JAK, so maybe just offer your perspective on those two questions here?

好的。 另一个问题。 我知道你们已经获得的只是FDA AdCom的一个潜力,那么如何考虑这个标签并且FDA是否认为这是一种类别标签,或者你们认为你们可以开拓 与其他一些JAK相比,差异化的标签,所以也许只是在这里提出你对这两个问题的看法?

Mike Severino

Certainly. So we are reasonably far along in our review process right now. And we don't at this point expect an advisory committee based on all the discussions that we are having with the FDA. So we feel good about the progress we are making in the review. It's a little bit early to make exact predictions about the label. But we think that the data that we've generated, not only the efficacy data, but also the safety data which shows a robust benefit/risk profile, showed rates of DTEs, in particular, which is something that’s been of the interest in this class that were no different between upadacitinib and the comparators. And that's true whether the comparators were adalimumab, methotrexate or true placebo. We feel like that puts us in a very good position for those negotiations.

当然。 因此,我们现在在审核过程中走得相当远。 此时我们还没有期待一个基于我们与FDA讨论的所有讨论的咨询委员会。 因此,我们对审核中取得的进展感到满意。 对标签做出准确的预测还有点早。 但我们认为,我们生成的数据,不仅是效力数据,还有显示强大的利益/风险状况的安全数据,显示了DTE的比率,特别是这对此感兴趣。 upadacitinib和比较者之间没有区别的类。 无论对照者是阿达木单抗,甲氨蝶呤还是真正的安慰剂,都是如此。 我们认为这使我们在谈判中处于非常有利的地位。

Terence C. Flynn

Okay. So you feel like there is a possibility that you won't have that blackbox warning for DVT?

好的。 所以你觉得你有可能不会对DVT发出黑盒警告吗?

Mike Severino

Again, it's a bit early to make predictions about what the label looks like, but we feel that we are in a very strong position. We feel we have a very strong data set. We've looked very carefully for any evidence of increased risk and we haven't demonstrated that. The rates have been the same across upadacitinib both doses and similar in the same in fact compared to all of the different comparators that we included in the programs, we think that puts us in a very strong position.

同样,对标签的外观进行预测还为时过早,但我们觉得我们处于非常有利的位置。 我们觉得我们拥有非常强大的数据集。 我们仔细查看了任何风险增加的证据,但我们没有证明这一点。 与我们在计划中包含的所有不同比较物相比,upadacitinib两种剂量和相似剂量的比率相同,我们认为这使我们处于非常有利的地位。

Terence C. Flynn

Okay. One other thing is just thinking about -- maybe the -- walk us through kind of the education effort that it will take you think to kind of continue to build the JAK class, because some of those historical questions recognizing you guys might have the safest, cleanest profile, but how do you really build the totality of the data to kind of drive uptake of the JAK class, maybe better than what we've seen from some of the prior drugs out there?

好的。 另外一件事就是考虑 - 也许是 - 让我们通过一些教育工作,你会想到继续建立JAK课程,因为一些承认你们的历史问题可能是最安全的 最干净的个人资料,但是你如何才能真正建立数据的整体来推动JAK级别的推动,可能比我们从之前的一些药物中看到的更好?

Mike Severino

Well it starts with having a very strong data package, which we have. And then if you look at our track record, we are an organization that has a very strong commercial presence, a marketing presence in the space. And we understand how to drive messages that resonate with patients and with physicians. We’ve a very, very strong medical affairs capabilities. We are committed to ongoing data generation, data communication. We’ve shown that we’re very effective there. And we know this space very well. This is a space we’ve been leaders for many years. So we think we understand how to not only develop, but how to commercialize this product and how to make sure that the attributes of the product are well understood by treating physicians and by patients.

好吧,它开始于拥有一个非常强大的数据包,我们有。 然后,如果你看一下我们的业绩记录,我们就是一个拥有非常强大的商业存在,在该领域营销的组织。 我们了解如何驱动与患者和医生产生共鸣的信息。 我们拥有非常非常强大的医疗事务能力。 我们致力于持续的数据生成,数据通信。 我们已经证明我们在那里非常有效。 我们非常了解这个空间。 这是我们多年来一直领导的空间。 因此,我们认为我们不仅了解如何开发,而且如何将该产品商业化以及如何确保通过治疗医生和患者很好地理解产品的属性。

Terence C. Flynn

And maybe the last question in this topic. Can you just remind us how we should think about the cadence of label indications building for SKYRIZI and upadacitinib? I think you guys have provided some guidance in terms of where you want to end up relative to HUMIRA over a certain number of years, but again just maybe walk us through kind of the cadence of some of those label [ph]?

也许是本主题中的最后一个问题。 您能否提醒我们如何考虑为SKYRIZI和upadacitinib建立标签适应症的节奏? 我想你们已经提供了一些关于你想要在一定年限内相对于HUMIRA最终结果的指导,但是再一次可能只是让我们了解一些标签[ph]的节奏?

Mike Severino

We haven't given year-by-year guidance on all of the indications, but I can talk to you about the rollout. So for SKYRIZI, obviously psoriasis is the initial indication. It's now in launch mode approved earlier this year. Important additional indications for SKYRIZI that are well along would be the inflammatory bowel disease indications. So that would include Crohn's disease and ulcerative colitis both being studied in Phase 3. Psoriatic arthritis is another important indication for SKYRIZI and those would be the core there. Although there are additional indications that are in mid stage testing as well. Pre-baricitinib, obviously, rheumatoid arthritis is the most advanced approaching the approval decisions in the second half of this year. Additional indications that are very important there would also be psoriatic arthritis. We think the combination of those two agents used in combination, but having both in your profile -- in your portfolio will be a very strong offering for patients who are being treated for psoriatic arthritis. Also an important indication for upadacitinib will be atopic dermatitis, which is coming in the not-too-distant future. We are well along in the Phase 3 program and that I think is an under recognized opportunity for a drug like upadacitinib. And we drove very, very strong data in our Phase 2 program, we had the breakthrough therapy designation, so I think that will be a very meaningful opportunity. Then we also have programs for upadacitinib in inflammatory bowel disease. So Crohn's disease and UC would sort of be the next ones out. And then if you look further out in the horizon, additional forms of arthritis treated by rheumatologists, ankylosing spondylitis, for example, has significant potential. And then giant cell arthritis and other condition treated by rheumatologists would be sort of the furthest out in that horizon. So there's room for indication expansion over the next several years for both of these molecules with the potential to cover up to about 12 different indications.

我们没有就所有迹象提供逐年指导,但我可以跟你谈谈推出的问题。所以对于SKYRIZI来说,牛皮癣显然是最初的迹象。它现在处于今年早些时候批准的发射模式。 SKYRIZI的重要补充指征是炎症性肠病适应症。这将包括在第3阶段研究的克罗恩病和溃疡性结肠炎。银屑病关节炎是SKYRIZI的另一个重要指征,那些将是那里的核心。虽然还有其他迹象表明处于中期测试阶段。显然,前拉西替尼,类风湿性关节炎是接近今年下半年批准决定的最先进的。其他非常重要的适应症也是银屑病关节炎。我们认为这两种药物联合使用的组合,但在您的档案中同时具有这两种药物 - 在您的投资组合中对于正在接受银屑病关节炎治疗的患者来说将是一个非常强大的产品。对于upadacitinib而言,重要的适应症将是特应性皮炎,这种疾病将在不久的将来出现。我们在第3阶段计划中表现良好,我认为这是一种公认​​的机会,如upadacitinib这样的药物。我们在第二阶段计划中提供了非常非常强大的数据,我们有突破性的治疗指定,所以我认为这将是一个非常有意义的机会。然后我们还有针对炎症性肠病的upadacitinib的程序。因此克罗恩病和UC将成为下一个。然后,如果你在视野中进一步观察,由风湿病学家治疗的其他形式的关节炎,例如强直性脊柱炎,具有巨大的潜力。然后由风湿病学家治疗的巨细胞关节炎和其他病症将是那种视野中最远的一种。因此,对于这两种分子来说,未来几年都有适应症扩大的空间,有可能覆盖大约12种不同的适应症。

Terence C. Flynn

And will most of those come on board before 2023 or kind of in that timeframe?

大多数人会在2023年之前登上或者在那段时间内出现吗?

Mike Severino

Yes, the majority of this is happening between now and 2023.

是的,大多数情况发生在现在和2023年之间。

Terence C. Flynn

Okay, great. Maybe moving on to HUMIRA. Again, I think you guys are front and center in terms of some of the biosimilar experience going on in Europe right now. Would just love your perspective on kind of what surprised you? What was in line with expectations? And then where we in terms of price right now do you think kind of reaching a stability point on the pricing side?

好,太棒了。 也许转向HUMIRA。 同样,我认为你们现在是欧洲正在进行的一些生物仿制经验的前沿和中心。 只是喜欢你对你感到惊讶的看法吗? 什么符合预期? 那么我们现在在价格方面你认为在价格方面达到了稳定点吗?

Mike Severino

Sure. So ex-U.S HUMIRA the competition has been more than the analysts would have predicted. We said at the beginning of the year that we expected revenue ex-U.S to be down about 30%, reflecting the impact of direct biosimilar competition. And if you look at where we are now, we feel good about that guidance. When we gave that guidance, we based it not only on what was happening at the time, but also based on assumptions or predictions around continued price erosion through the year, we continue to feel good about those predictions. So we feel like we have a good handle on it this year.

当然。 所以前美国的HUMIRA比竞争对手的预期更多。 我们在年初表示,我们预计美国以外的收入将下降约30%,这反映了直接生物仿制药竞争的影响。 如果你看看我们现在的位置,我们对这个指导感觉很好。 当我们给出这个指导时,我们不仅基于当时发生的事情,而且基于对全年持续价格侵蚀的假设或预测,我们对这些预测仍然感觉良好。 所以我们觉得今年我们有很好的处理方式。

Terence C. Flynn

Okay.

好的。

Mike Severino

And I think there's some confusion potentially on the first quarter call in terms of the quarterly guidance, but if you think about it, we are going to lap the event in the fourth quarter. So the guidance we gave in the second quarter you expect -- before you lap the event as we have additional erosion that we -- as Mike mentioned, is included in our guidance. You will see a high-level of erosion, but then as you lap in the fourth quarter you see it moderating.

而且我认为在季度指引方面,第一季度电话会有一些混乱,但如果你考虑一下,我们将在第四季度进行这项活动。 因此,我们在第二季度给出的指导意见 - 在您参加活动之前,因为我们有额外的侵蚀,我们 - 正如迈克提到的那样,包含在我们的指导中。 你会看到一个高水平的侵蚀,但是当你在第四季度一圈时,你会看到它有所缓和。

Terence C. Flynn

Okay. And then in terms of pricing, any visibility as pricing kind of stabilized at this point in terms of European experience?

好的。 然后在定价方面,任何在欧洲经验方面稳定的定价类型的可见性?

Rob Michael

Yes, I mean, the markets are very different. So in the cases of tender markets where you have annual price setting, we have obviously a very good visibility there. Mandatory priced top markets have very good visibility. It's a contracting markets where you could see over the course of the year some additional erosion that was factored into our guidance.

是的,我的意思是,市场非常不同。 因此,对于年度价格设定的投标市场,我们显然具有非常好的可见度。 强制定价的顶级市场具有非常好的知名度。 这是一个承包市场,您可以在一年中看到一些额外的侵蚀,这些侵蚀已被纳入我们的指导。

Terence C. Flynn

Okay. And then I think next year you said you expect less of an impact and then maybe another impact coming 2021, is that still just given the cadence of some of the other patents [multiple speakers]?

好的。 然后我认为明年你说你预计会产生更少的影响,然后可能会在2021年产生另一种影响,那还是仅仅考虑了其他一些专利[多个发言者]的节奏吗?

Mike Severino

If you look at -- so, our international business is about 75% of that revenue has direct biosimilar competition today. So that other 25%, the most significant market actually go beyond 2020, there are some that go in 2020. As you think about the 2020 erosion, you will have in the market that have biosimilar competition today, some level of erosion, but again as you think about typical erosion curves, you don’t see the same level in year two as you do in year one.

如果你看一下 - 那么,我们的国际业务大约有75%的收入在今天有直接的生物仿制品竞争。 因此,其他25%,最重要的市场实际上超过2020年,有一些在2020年。当你想到2020年的侵蚀时,你将在市场上拥有今天的生物仿制品竞争,一定程度的侵蚀,但又一次 当您考虑典型的侵蚀曲线时,您在第二年看不到与第一年相同的水平。

Terence C. Flynn

Okay. And maybe one of the other things and again I think it's difficult to project, but maybe help us think about the puts and takes on the U.S side of the business, because I know that’s something else investors have been debating and just again how to think about that? We've seen some metrics from REMICADE, from Neulasta, Neupogen, but not a lot of analogues maybe as in Europe. So what are kind of the puts and takes and then when we think about the rebate rule changes or interchangeability, where did those fall in terms of how to think about the U.S biosimilar impact?

好的。 也许其中一个又一个我认为很难投射,但也许可以帮助我们考虑投资并承担美国方面的业务,因为我知道这是投资者一直在辩论的其他事情,并且再一次如何思考 关于那个? 我们已经看到来自Neulasta,Neupogen的REMICADE的一些指标,但可能没有像欧洲那样的许多类似物。 那么什么是投入和消费,然后当我们考虑回扣规则的变化或可互换性时,那些在如何考虑美国生物仿制药影响的方面呢?

Mike Severino

Yes, so obviously, we’re not in a position to give guidance on the impact of direct biosimilars in the U.S at this point. When we look at the European experience, Europe is a heterogeneous market as Rob said. And not all of the other countries behave in the same way. You have the tender countries, you have the larger more contracting base countries. So we’re obviously going to pay close attention to the dynamic that played out in Europe. As we prepare for the U.S biosimilar then, but there's no one country that's an analog for the U.S system, and there's going to be a range of payer behavior as we approach that event. With respect to the rebate rule, as I said, I think we can compete effectively under the current system. Obviously, we are under a system where we just go in or replace with upfront discounts. We don’t really see that playing in significantly to our strategy.

是的,很明显,我们目前无法就直接生物仿制药在美国的影响提供指导。 当我们看欧洲的经验时,欧洲是一个异质的市场,正如Rob所说。 并非所有其他国家的行为方式都相同。 你有招标国家,你有更大的承包基地国家。 因此,我们显然会密切关注欧洲的动态。 当我们为美国生物仿制药做准备的时候,但是没有一个国家是美国体系的模拟物,当我们接近这个事件时,会有一系列的付款人行为。 关于退税规则,正如我所说,我认为我们可以在现行制度下有效竞争。 显然,我们处于一个系统,我们只是进入或取代前期折扣。 我们并没有真正看到这对我们的策略有重大影响。

Terence C. Flynn

And on interchangeability, I know the FDA came out with this guidance recently. It looks like, obviously companies will have to do additional clinical work to get an interchangeability designation, probably varies by drug, but would be curious just your perspective on that guidance. And again, what you -- if we could have interchangeable biosimilars in that 2023 time frame or if we should just expect biosimilar and maybe doesn't even matter in your perspective?

关于可互换性,我知道FDA最近提出了这个指导。 看起来,显然公司将不得不做额外的临床工作以获得可互换性指定,可能因药物而异,但仅仅是您对该指导的看法。 再说一遍,你是什么 - 如果我们能够在2023年的时间框架内拥有可互换的生物仿制药,或者我们是否应该期待生物仿制药,甚至可能在你看来并不重要?

Mike Severino

So, there's been draft guidance out on interchangeability for a while now and the final guidance came out just a few months ago. If you look at the two, the final guidance is really very consistent with the draft guidance, where a few changes and emphasis more on the analytical side.

因此,现在有关于可互换性的草案指南已有一段时间了,最后的指导就在几个月前发布了。 如果你看两者,最终的指导实际上与指南草案非常一致,其中一些变化和重点更多地放在分析方面。

Terence C. Flynn

Okay.

好的。

Mike Severino

But the basic framework I think stayed in place. And the basic requirement and additional -- in addition to the requirements for biosimilarity are the requirement for additional clinical work with a multi panel switch, so four panels, two exposure periods on each agent with a demonstration of biosimilarity across that experience. And so that has been the framework I think for some time since that draft guidance came out. So we don’t really see a big change. If you look at our assumptions around interchangeable biosimilars, we assume that there will be at least one interchangeable biosimilar in 2023 and that’s already baked into our planning. So nothing about the guidance changes there.

但我认为基本框架仍然存在。 基本要求和附加 - 除了对生物相似性的要求之外,还需要使用多面板开关进行额外的临床工作,因此需要四个面板,每个代理的两个暴露期,并在该经历中展示生物相似性。 因此,自从该指南草案出台以来,我一直认为这是一个框架。 所以我们并没有真正看到一个很大的变化。 如果你看看我们对可互换生物仿制药的假设,我们假设在2023年将至少有一种可互换的生物仿制药,并且已经纳入我们的计划中。 所以指导没有任何改变。

Terence C. Flynn

Okay. Maybe next big picture question is just would love your latest thoughts on capital allocation. Obviously, you guys have been active previously on the business development front, the share repurchases as well. But how are thinking about balancing those given your current balance sheet and kind of some of the pipeline opportunity you talked about?

好的。 也许下一个大图片问题只是会喜欢你对资本配置的最新想法。 显然,你们之前一直活跃在业务发展方面,股票回购也是如此。 但是,考虑到您目前的资产负债表以及您谈到的一些管道机会,如何考虑平衡这些?

Mike Severino

Sure. Well when we talk about capital allocation, it's important to note that having a robust in growing dividend is an important part of our investment thesis and will continue to be an important part of our investment thesis. We are fortunate to have a very strong, very robust and growing business that gives us a lot of opportunities. We are always looking to reinvest in our business. We are always looking to grow our business. So when we look at the business development opportunities, we analyze a wide range of opportunities, small medium and large. And we have the ability to get things done when we see something we think is going to be a strong strategic fit, something that will drive value for shareholders. So that hasn’t changed. And on the share repurchase side, we’re going to do that more opportunistically. We’ve taken care of the first two priorities, the dividend and investing in our business where we have excess cash, then we can buy back shares more opportunistically.

当然。 当我们谈论资本配置时,重要的是要注意,增加股息的稳健性是我们投资理论的重要组成部分,并将继续成为我们投资理论的重要组成部分。 我们很幸运有一个非常强大,非常强大和不断发展的业务,为我们提供了很多机会。 我们一直在寻求对我们的业务进行再投资。 我们一直在寻求发展我们的业务。 因此,当我们看到业务发展机会时,我们会分析各种各样的机会,无论大中小型。 当我们看到一些我们认为具有强大战略意义的东西时,我们就能够完成任务,这将为股东带来价值。 所以这没有改变。 在股票回购方面,我们将更加机会主义地做到这一点。 我们已经处理了前两个优先事项,股息和投资我们的业务,我们有多余的现金,然后我们可以更机会地回购股票。

Rob Michael

And last year we had a higher level of share repurchase because we made a commitment coming out of tax reform to capital shareholders. So I wouldn’t expect, if you look at 2018, buyback levels to be the go forward assumption.

去年我们进行了更高水平的股票回购,因为我们向资本股东提出了改革承诺。 所以我不指望,如果你看2018年,回购水平是前瞻性的假设。

Terence C. Flynn

Sure. And on the BD front, again, I think when I look back at some of the deals you guys did, I would say maybe Pharmacyclics surprised people just because that was kind of outside of your wheelhouse, but yet turn -- has turned out to be a good deal in terms of where IMBRUVICA is and obviously you’re bringing on VENCLEXTA to kind of layer on to that hem/onc franchise that you brought in. Stemcentrx, maybe on the other side in terms of -- the outcome there not where you guys have hoped for, but again was somewhat out-of-the-box in terms of the platform deal maybe that bring you into the solid tumors. So as you think about kind of therapeutic areas are going outside of your core, I mean, how do you think about balancing those, obviously, recognizing your core in immunology and cancer now. But maybe moving into like a new therapeutic area, how important is that for you guys from a diversification standpoint?

当然。 在BD方面,再次,我想当我回顾你们做过的一些交易时,我会说也许Pharmacyclics让人感到惊讶,因为那种情况只是在你的驾驶室之外,但转向 - 已经证明了 在IMBRUVICA的位置上是一个很好的交易,显然你将VENCLEXTA带到了你带来的那个下摆/ onc特许经营层.Stemcentrx,也许在另一方面 - 结果没有 你们所希望的地方,但在平台协议方面再次有点开箱即用,这可能会让你进入实体肿瘤。 因此,当你想到某种治疗领域超出你的核心时,我的意思是,你如何考虑平衡这些,显然,现在认识到你在免疫学和癌症方面的核心。 但也许进入一个新的治疗领域,从多元化的角度来看,对你们来说有多重要?

Mike Severino

Well, as we said, we are going to analyze a wide range of opportunities. And if you look at what we've done historically, Pharmacyclics, I do think was a very good deal. It was a controversial deal that we did it, but I think it has shown to be a very good deal. It advanced our position in hematology, oncology very substantially. It was a very strong fit with VENCLEXTA, so was -- have that very strong strategic fit which I think is important, and there's very strong complementarity between those two assets. Since the Pharmacyclics deal broke has grown very, very substantially in line with the initial projections that we made, so we feel good about that -- about the progress there. Obviously, Stemcentrx there, the outcome was not what the early data would have predicted or what we'd have hoped. So we recognize that. But when we look at a wide range of opportunities, we are going to look at many different sorts of deals. We are going to look at early-stage deals that that add to our early pipeline and those are the things you’ve seen us do more recently. We might look at other sorts of deals that could take us into new therapeutic areas. We are going to keep a wide aperture. And as I said, we have the ability when we see something that is a strong strategic fit to bring it in-house.

好吧,正如我们所说,我们将分析各种各样的机会。如果你看看我们历史上所做的事情,Pharmacyclics,我认为这是一个非常好的交易。这是一个有争议的交易我们做到了,但我认为它已经证明是一个非常好的交易。它极大地提升了我们在血液学,肿瘤学方面的地位。这与VENCLEXTA非常契合,所以 - 我认为非常强大的战略契合度很重要,而且这两种资产之间存在很强的互补性。由于Pharmacyclics交易破裂已经非常,非常符合我们的初步预测,所以我们对此感到满意 - 关于那里的进展。显然,Stemcentrx在那里,结果不是早期数据预测的或者我们希望的结果。所以我们认识到了。但是,当我们看到广泛的机会时,我们将会看到许多不同类型的交易。我们将看看早期阶段的交易,这些交易会增加我们早期的管道,而这些是您最近看到我们做过的事情。我们可能会考虑其他可能将我们带入新治疗领域的交易。我们将保持宽阔的光圈。正如我所说,当我们看到一些具有强大战略意义的内容时,我们就有能力将其带入内部。

Terence C. Flynn

How are you thinking about kind of opportunity set and valuation now in some of those kind of assets? Because I know it waxes and wanes, but do you think there is still a pretty deep opportunity set out there? Or do you think valuations are somewhat constraining?

您是如何考虑某些资产中的机会设定和估值? 因为我知道它会变得枯萎,但你认为那里还有一个非常深刻的机会吗? 或者您认为估值有些制约吗?

Mike Severino

Well, it depends on the therapeutic area and it depends on the stage of development. So there are certainly certain areas for valuations that are still very high. So mid-stage oncology, for example, valuations are high. That doesn’t mean there aren't opportunities out there, but one just has to be very thoughtful about what you pursue. There can be value in other sorts of deals. More recently we found value in early-stage deals, things that were a pre-proof-of-concept either moving towards the clinic or in very early clinical development. But we’re going to look across that set, small, medium and large opportunities and assess where we see value.

那么,这取决于治疗领域,这取决于发展阶段。 因此,某些估值领域仍然非常高。 例如,中期肿瘤学,估值很高。 这并不意味着那里没有机会,但只需要对你所追求的东西非常周到。 其他类型的交易可能有价值。 最近,我们发现了早期交易的价值,这些都是一个预先证明概念的事情,要么转向临床,要么在早期的临床开发中。 但我们会仔细研究这一组,小型,中型和大型机会,并评估我们看到的价值所在。

Terence C. Flynn

Okay. Maybe just moving on to IMBRUVICA, maybe just help us think about some of the key drivers of growth here. And then on the flipside, one of the -- there are a number of these competitor BTK trials ongoing, so would just love your perspective on kind of how you see all that falling out and what are you guys doing to maybe again set a higher bar with IMBRUVICA and the backbone agent that you have?

好的。 也许只是转到IMBRUVICA,也许只是帮助我们思考一些增长的关键驱动因素。 然后另一方面 - 其中一个 - 这些竞争对手的BTK试验正在进行中,所以只是喜欢你对你如何看待所有那些堕落的看法以及你们做了什么可能再次设置更高 有IMBRUVICA的酒吧和您拥有的骨干代理商?

Mike Severino

So IMBRUVICA has been an asset that's growing very, very robustly over the last several years. The most important area of growth for IMBRUVICA is continued movement into front-line CLL. So IMBRUVICA has changed the standard of care in CLL and is now well along the way in terms of moving from second line use to first line use and first line share has been growing. And continuing that momentum I think is going to be very important. That’s going to happen on the strength of a number of very, very important clinical readout. So at the end of last year, we reported readouts from three long-term randomized Phase 3 trials that showed superiority against essentially all of the standards of care in the field. So, VR, FCR, GAZYVA, [indiscernible]. So it's on the strength of those data, on the strength of subsequent recommending body recommendations that we are going to make that move, and that's the most important part of the growth. There's also room to increase penetration and move forwarding lines of therapy in other areas where IMBRUVICA is active. So in some of the non-Hodgkin lymphomas like mantle-cell lymphoma, marginal-cell lymphoma. And we are working overtime on other areas like follicular lymphoma for example. And then the last area would be GVHD, which is a small, but important indication that offers a treatment option for patients who haven't had anyone in many, many years. So we think there are a number of areas where IMBRUVICA can continue to grow. When we look at the follow-on products, we see them as essential additives. The story initially had been by having a slightly different mix of specificity, maybe one could get away from bleeding or other complications that we feel strongly are on mechanism for BTK inhibitor. So it's important to manage patient safety and they should be managed appropriately with their own mechanism than a slightly different mix of specificity isn't going to change that. And if you look at how the field has developed, I think you see that playing out. So the initial hope was that there would be no bleeding. You see bleeding rates are at the same as the rates with IMBRUVICA now and later stage trials people have focused on afib. And for a while, people thought perhaps there should be no afib. Now you see afib rates look very, very similar to ours, which is all very consistent with our hypothesis that these are on mechanism adverse experiences that they need to be managed carefully, but they’re going to part and parcel of the BTK inhibitor. And the primary advantage that we’ve is we are much with our own development. So we have multiple long-term Phase 3 studies that show impact on PFS, impact on OS at a time period where the follow-on agents try and catch up. So we are going to make sure we take advantage of that lead in data generation that lead in time on the market to drive the success of IMBRUVICA.

因此,IMBRUVICA在过去几年中一直是非常强劲增长的资产。 IMBRUVICA最重要的增长领域是继续进入前线CLL。所以IMBRUVICA已经改变了CLL的护理标准,现在在从二线使用转向一线使用方面已经很顺利,并且第一线的份额一直在增​​长。继续这种势头我认为非常重要。这将通过许多非常非常重要的临床读数来实现。因此,在去年年底,我们报告了三项长期随机3期临床试验的读数,这些试验显示出对该领域基本上所有护理标准的优越性。所以,VR,FCR,GAZYVA,[音频不清晰]。因此,根据这些数据的优势,根据我们将要采取的后续推荐机构建议的强度,这是增长中最重要的部分。在IMBRUVICA活跃的其他区域,还有增加穿透力和移动治疗线的空间。所以在一些非霍奇金淋巴瘤中,如外套细胞淋巴瘤,边缘细胞淋巴瘤。我们正在加班加点其他领域,如滤泡性淋巴瘤。然后最后一个区域是GVHD,这是一个很小但很重要的指示,为多年来没有任何人的患者提供治疗选择。因此,我们认为IMBRUVICA可以继续增长的领域有很多。当我们看后续产品时,我们将它们视为必不可少的添加剂。最初的故事是由于特异性稍有不同,也许可以避免出血或其他并发症,我们认为BTK抑制剂的机制很强。因此,管理患者安全非常重要,应该使用自己的机制对其进行适当管理,而不是稍微不同的特异性组合就不会改变这种情况。如果你看看这个领域是如何发展的,我认为你会看到这一点。所以最初的希望是没有出血。您看到出血率与IMBRUVICA现在的出院率相同,后期阶段试验的人员一直关注afib。有一段时间,人们认为也许应该没有afib。现在你看到afib率看起来非常非常类似于我们的,这与我们的假设是非常一致的,即这些是机制上的不良经验,需要仔细管理,但它们将成为BTK抑制剂的一部分。我们的主要优势在于我们自身的发展。因此,我们有多个长期的第3阶段研究,显示对PFS的影响,在后续代理尝试赶上的时间段对操作系统的影响。因此,我们将确保利用数据生成方面的优势,及时推动市场推动IMBRUVICA的成功。

Terence C. Flynn

Okay. One of the other things that I thought was -- you guys reports impressive combination data IMBRUVICA/VENCLEXTA. And it seems to me like there was this move in CLL to maybe shorter fix course of treatment duration and MRD negativity. So maybe just help us think about how to frame that data, and then what is the impact that that could have on the marketplace looking forward? Obviously, you guys have economics on both IMBRUVICA and VENCLEXTA, but what does that mean for the CLL market?

好的。 我想到的其他事情之一 - 你们报告了令人印象深刻的组合数据IMBRUVICA / VENCLEXTA。 而且在我看来,CLL中的这一举动可能会缩短治疗时间和MRD消极性。 所以,也许只是帮助我们思考如何构建数据,然后可能对市场呈现的影响是什么? 显然,你们在IMBRUVICA和VENCLEXTA都有经济学,但这对CLL市场意味着什么?

Mike Severino

Well, we have generated some very impressive mid-stage data with the combination of IMBRUVICA and VENCLEXTA. And when we did the Pharmacyclics acquisition, we saw the complementarity of these two agents, not just in terms of the complementarity of operating the same space, but the ability to combine them. And there were strong scientific rationale at that time to combine them based on the mechanisms in which they kill leukemic cells, and that I think has played out through those mid stage studies. We are seeing very deep response -- very high levels of response, very deep responses. And over time, we will generate the data to show very durable responses, I believe, with a combination of those two agents. So when I think the combination of IMBRUVICA and VENCLEXTA is going to provide an important treatment option in the future for patients with CLL. If you look at the CLL market, it's very heterogeneous. So first of all, heterogeneous in terms of the patient populations. Many patients gets CLL later in life. In the 70s or 80s, they may have multiple comorbid illnesses and for those patients monotherapy treatment progression is a very attractive option as we’ve seen. There are other patients who get CLL much earlier in life and they’ve fewer comorbid illnesses maybe essentially they’re only medical condition. And in those sorts of patients we see physicians today offer treatment intensification and a finite duration of therapy. And so we think that we can develop across these two agents a portfolio of regimens that can manage that that full set of patients. So we think that monotherapy treat progressions is going to continue to be important for quite some time, but we also know that there are a number of patients today who don't want to treat it that way. So we’ve about 27% new to market share for IMBRUVICA, which means that there's a large number of patients who are being treated in another ways. We think the combination of IMBRUVICA and VENCLEXTA driving those deep responses, offering the potential for a short duration of therapy or shorter duration of therapy finite therapy with a long duration of disease-free survival would be very, very important. And so we think that across those two assets, we can revolutionize the standard of care for CLL.

好吧,我们通过IMBRUVICA和VENCLEXTA的组合产生了一些非常令人印象深刻的中期数据。当我们收购Pharmacyclics时,我们看到了这两种药剂的互补性,不仅仅是在操作相同空间的互补性方面,而且是将它们结合起来的能力。当时有很强的科学理论基于它们杀死白血病细胞的机制将它们结合起来,而且我认为通过这些中期研究发挥了作用。我们看到了非常深刻的反应 - 非常高的响应水平,非常深刻的反应。随着时间的推移,我们将生成数据,以显示非常持久的响应,我相信,这两个代理的组合。因此,当我认为IMBRUVICA和VENCLEXTA的组合将在未来为CLL患者提供重要的治疗选择时。如果你看一下CLL市场,那就非常不同了。首先,就患者人群而言是异质的。许多患者在以后的生活中获得CLL。在70年代或80年代,他们可能患有多种合并疾病,对于那些患者,单药治疗进展是一个非常有吸引力的选择,正如我们所见。还有其他患者在生命早期得到CLL,并且他们患有共病的可能性较少,可能基本上他们只是医疗条件。在那些类型的患者中,我们看到今天的医生提供治疗强化和有限的治疗持续时间。因此,我们认为我们可以在这两个代理商之间开发一系列可以管理全套患者的治疗方案。因此,我们认为单药治疗治疗进展将在相当长的一段时间内继续发挥作用,但我们也知道今天有许多患者不希望以这种方式治疗。因此,IMBRUVICA的市场份额约为27%,这意味着有大量患者正在以另一种方式接受治疗。我们认为IMBRUVICA和VENCLEXTA的结合可以推动这些深层反应,提供短期治疗的潜力或更短的治疗时间,长期无病生存的有限治疗将非常非常重要。因此,我们认为,通过这两项资产,我们可以彻底改变CLL的护理标准。

Terence C. Flynn

Okay. And as you think about your long-range targets for these drugs, can you give us any sense of kind of how you thought about the duration component in that -- in particular on IMBRUVICA side?

好的。 当你考虑这些药物的远程目标时,你能不能给我们任何关于持续时间成分的想法 - 特别是在IMBRUVICA方面?

Mike Severino

Well as I said, there -- it's a heterogeneous population. So we think that monotherapy treat progression is going to continue to be important for a number of patients. So it's not so much a duration question for those patients, it's more a market expansion question for patients who aren't being treated that way today. So I think that there is still be a large component to get monotherapy treat progression and those have shown very durable long-term results with IMBRUVICA. I think that's going to continue, but there's a large group of patients that we're not accessing today. And I think we can access them with the combination. So it's really more about market expansion and duration of therapy. And if you think about duration of therapy, you really have to think about it in terms of those two different patients [indiscernible].

就像我说的那样 - 那是一个异质的人口。 因此,我们认为单药治疗进展对于许多患者来说将继续是重要的。 因此对于那些患者而言,这不是一个持续性问题,对于那些今天没有接受过治疗的患者来说,这更像是一个市场扩张问题。 因此,我认为单药疗法治疗进展仍有很大的成分,而IMBRUVICA则显示出非常持久的长期疗效。 我认为这种情况会持续下去,但是我们今天无法访问的是一大群患者。 我认为我们可以通过组合访问它们。 因此,它更多的是关于市场扩张和治疗持续时间。 如果你考虑治疗的持续时间,你真的不得不考虑这两个不同的患者[音频不清晰]。

Terence C. Flynn

Okay. Maybe just in -- the last minute and half here. Would just love to hear your last thoughts on the hep C market kind of where do we stand in terms of driving that new diagnosis rate? And again are you fairly confident that we should see a continuous inflow of new patients now at kind of the point where we’re at right now?

好的。 也许只是 - 在这里的最后一分钟和一半。 您是否愿意听听您对肝脏C市场的最新想法,我们在推动新诊断率方面的立场是什么? 您再次相信我们现在应该看到新患者的持续流入,我们现在处于什么样的地步?

Mike Severino

So, the hep C market is obviously one that has stabilized considerably in the last couple of years. A lot of the warehouse patients have obviously been treated. It's not so much solely about new diagnosis as treating the diagnosed and untreated pool.

因此,肝脏C市场显然是在过去几年中已经稳定下来的市场。 很多仓库患者明显得到了治疗。 它不仅仅是关于治疗诊断和未治疗池的新诊断。

Terence C. Flynn

Okay.

好的。

Mike Severino

And those patients exist in a wide range of locations. They exist in areas where there may be underserved communities, they may be in areas where for whatever reason they haven't had access to care. And so understanding that market and driving approaches they get those patients and the care is going to be an important part as well as in many of those same locations there are undiagnosed patients and getting those patients in the care and getting them diagnosed is important. So it's really both sides of that equation.

这些患者存在于广泛的地方。 它们存在于可能存在服务欠缺社区的地区,它们可能出现在无论何种原因无法获得护理的地区。 因此,了解他们获得这些患者的市场和驾驶方法以及护理将是一个重要的部分,并且在许多相同的位置,未确诊的患者和让这些患者接受治疗并让他们被诊断是重要的。 所以它确实是这个等式的两个方面。

Terence C. Flynn

Okay. So you feel like there's still enough of market out there from the current kind of level where we’re at to drive some sustainable tail here in this franchise?

好的。 所以你觉得从目前的水平还有足够的市场,我们正在这个特许经营中推动一些可持续的尾巴?

Mike Severino

We do. I mean, we think it's going to be a durable market for many, many years to come. We’ve projected slight decreases in patient numbers over time and I think that is likely to play out in that way, but we do see it as a durable market for many years. If you look at the patients who are just diagnosed and untreated, there are many patients in that bucket where at current annual treatment rates, this is a durable market for many, many years. Put some numbers around it. So there was like 425,000 treated patients going to 300,000 in 2027. So it's going to be a market that will generate, I would say, a durable cash flow for the company.

我们的确是。 我的意思是,我们认为它将在未来许多年内成为一个持久的市场。 我们预计患者数量会随着时间的推移略有下降,我认为这可能会以这种方式发挥作用,但我们确实将其视为多年来持久的市场。 如果你看一下刚被诊断和未经治疗的患者,那么在该桶中有许多患者按照目前的年治疗率,这是一个持久的市场很多年。 在它周围加一些数字。 因此,在2027年,有425,000名接受治疗的患者达到30万人。因此,对于公司来说,这将成为一个可以产生持久现金流的市场。

Terence C. Flynn

Okay, great. Well, I think we’re out of time, but thank you very much, gentlemen. I really appreciate it.

好,太棒了。 嗯,我想我们已经没时间了,但非常感谢,先生们。 对此,我真的非常感激。

Mike Severino

All right. It's a pleasure. Thanks.

行。 我的荣幸。 谢谢。

Terence C. Flynn

Thanks, Mike.

谢谢,迈克。

问答环节

Q -
[No formal Q&A for this event]

问 -

[此活动没有正式问答]

相关问题

  • AbbVie Inc. 电话会议
  • AbbVie Inc. 财务报告

互联网券商的港股、美股开户教程

如果您对美股 或者 港股也感兴趣, 或者想要了解如何开户, 可以加我wechat: xiaobei006006, 同时也可以拉您进美股交流群哦。
最后的最后 祝大家都有一个美好的投资生活哦。

大家也可以关注【美股指南】公众号, 即可获得《小白投资美股指南(雪球「岛」系列)》电子书

写在最后

友情提示 转载请注明出处: https://investguider.com/topics/10519
暂无回复。
需要 登录 后方可回复, 如果你还没有账号请点击这里 注册