Eli Lilly and Company (NYSE:LLY) Goldman Sachs 40th Annual Global Helathcare Conference June 11, 2019 4:20 PM ET
Eli Lilly and Company（纽约证券交易所代码：[LLY]）Goldman Sachs第40届全球Helathcare会议2019年6月11日东部时间下午4:20
Josh Smiley – Chief Financial Officer
- Josh Smiley - 首席财务官
Terence Flynn – Goldman Sachs
- Terence Flynn - 高盛
Okay, great. I think we’re going to get started. Thanks so much for joining us for the afternoon session. I’m Terence Flynn, the biopharma analyst here at Goldman Sachs. We’re very pleased to have Eli Lilly with us this afternoon. Joining us from the company is Josh Smiley, CFO. Josh, thanks very much for taking the time.
好，太棒了。 我想我们要开始了。 非常感谢您参加下午的会议。 我是高盛（Goldman Sachs）生物制药分析师特伦斯•弗林（Terence Flynn）。 今天下午我们很高兴Eli Lilly和我们在一起。 加入我们公司的是首席财务官Josh Smiley。 乔希，非常感谢你抽出时间。
Thanks for having us.
Maybe just to get started, big picture, given your background and experience we just kind of love your thoughts on this question about broader industry consolidation. There’s been consolidation on the payer provider side now. Over the last couple of years, we saw another large transaction earlier this year in the biopharma space. So do you think this is the start of a trend here in the biopharma space in response to kind of the payer provider consolidation? Or do you expect kind of more bolt-on transactions to be the norm, which is what we saw kind of over the last couple of years?
也许只是为了开始，大局，鉴于你的背景和经验，我们只是喜欢你对这个关于更广泛的行业整合问题的想法。 现在付款人提供商方面已经整合了。 在过去几年中，我们在生物制药领域看到了今年早些时候的另一项大型交易。 因此，您是否认为这是生物制药领域趋势的开始，以响应付款人提供商合并的类型？ 或者你是否期望更多的螺栓式交易成为常态，这是我们在过去几年看到的那种情况？
Yes, well, I think Terence from Lilly’s perspective our interests would be in bolt-on and opportunities to enhance the pipeline. We’ve studied for a long-time the bigger acquisitions and at least from our vantage point, we don’t see them as making sense. We went through a patent expiration period and focused on investing and innovation. And we think that’s the way to manage through the – any turbulent time that’s coming whether that’s because you face a patent expiration or policy environments changing.
So from our perspective, we don’t see the changes either from a payer landscape perspective or a policy perspective as driving sort of a thought process from a consolidation perspective. Of course every company is different, but for us we think the future is going to be an innovation. We think the best way to do that is to do it as a lean company that mixes internal R&D with an external viewpoint. So we’ll continue to focus on that.
是的，好吧，我认为来自礼来公司的Terence，我们的利益将是坚持不懈的，并有机会加强管道。 我们长期研究更大的收购，至少从我们的观点来看，我们认为它们没有意义。 我们经历了专利到期期，专注于投资和创新。 而且我们认为这是通过任何动荡时期来管理的方式，无论是因为您面临专利到期还是政策环境的变化。
因此，从我们的角度来看，我们不会从付款人环境角度或政策角度看到这些变化是从整合角度推动思维过程。 当然，每家公司都不同，但对我们而言，我们认为未来将是一项创新。 我们认为最好的方法是将其作为一个将内部研发与外部观点相结合的精益公司。 所以我们将继续关注这一点。
Okay. And what’s the right – what do you think is the right mix of kind of external, internal as you guys think about balancing that?
好的。 什么是正确的 - 你认为什么是外部的，内部的正确组合，你们想到平衡它？
For now, what we look at is probably about two thirds internal, one third external. And that for us, I think when we look historically, we’ve done a good job in late phase of partnering and bringing in assets in earlier phases of development, getting to about one third sourced externally will be a move for us. But we think that’s a good mix. We don’t think you can be in a position where you’re exclusively or majority relying on external innovation. That’s just hard to manage. But at the same time, we know that the best ideas are many times going to be happening outside the walls of Lilly. So that’s the mix we’re looking for.
目前，我们看到的可能是内部的三分之二，外部的三分之一。 对我们而言，我认为，从历史的角度来看，我们在合作的后期阶段做得很好，并在早期的发展阶段引入资产，从外部采购大约三分之一将是我们的举措。 但我们认为这是一个很好的组合。 我们认为您无法独立或多数依赖外部创新。 这很难管理。 但与此同时，我们知道最好的想法很多时候会发生在礼来之外。 这就是我们正在寻找的组合。
Okay. Maybe that’s a good segue into the deal that you guys announced earlier this year Loxo transaction. Maybe just would love your thoughts. Just remind a strategic rationale there and then how you think about that as kind of continuing to build your presence on oncology and what should we be looking for as we think about measuring kind of your return on investment from that acquisition?
好的。 也许这是你们今年早些时候宣布的Loxo交易的一个很好的交易。 也许只会喜欢你的想法。 只是提醒那里的战略理由，然后你如何看待这种情况继续在肿瘤学上建立你的存在以及我们在考虑衡量你从那次收购中获得的投资回报时我们应该寻找什么？
Yes, sure. I think as it relates to any pipeline opportunity or project we’re looking at, our emphasis is on having drugs that are going to be either first or best in class. Now, of course, I think probably everybody up here says that, right? But what we saw with Loxo and what we’re going to focus on are the therapeutic areas we’re in today and oncology is one of them. What we saw with the Loxo opportunity is LOXO-292, the RET inhibitor. We saw it as an opportunity of both first and best. And as we had a chance to watch some of the data mature, we got to a point where we were convinced that there was enough data that this is going to be a drug. So we had a high probability of success on the – on 292.
We spent a lot of time on understanding the mutation, doing modeling to understand how many patients in the U.S. and around the world present each year with this mutation. And of course then did the work to figure out how quickly we could grow that market if we had the drug. We got to a number that we thought made sense. And I think what you saw from us is when we have conviction, we’re going to act fast and we were able to start the process with Loxo and concluded within a few weeks. That’s of course we’ve been thinking about it for a lot longer than a few weeks.
So I think what that would indicate or what you should look at as we think about things going forward, we’re going to look for high quality assets that provide meaningful benefits to patients that can be a first or best in class opportunity. And when we see those, we’re going to be aggressive in pursuing them obviously from a financial perspective. We’re going to make sure that whatever we pay to acquire or to partner the asset, there is still value on Lilly’s side. So I think when we look at the acquisition price of $8 billion it’s a little bit more than $8 billion. It was really all put against – almost all put against 292.
因此，当我们考虑未来的事情时，我认为这将表明或者您应该注意什么，我们将寻找高质量的资产，为患者提供有意义的益处，这可能是第一次或最佳的机会。当我们看到这些时，从财务角度来看，我们显然会积极地追求它们。我们将确保无论我们为收购或与资产合作而支付的费用，礼来方面仍有价值。所以我认为，当我们看到80亿美元的收购价时，它的价格略高于80亿美元。这真的是全部反对 - 几乎所有人都反对292。
And again, we’re assuming that it’s going to be a drug and then it’s going to be a function of how many patients can we get tested, what kind of share can we maintain. Again, we think we’ll be first, but there will be competitors. And then how long will patients stay on the medication and that’s what we looked at when we looked at the price then that we thought was reasonable. You can assume that that’s well above our – the returns will be well above our cost of capital and we see good returns for shareholders on the back end.
That’s the biggest deal we’ve done in our history, $8 billion. And so I don’t think you should expect that you’ll see ones of that magnitude of frequency. But when we see a great asset, and we have conviction around it, we think we can create value. We’re going to move aggressively.
而且，我们假设它将成为药物，然后它将成为我们可以测试多少患者的函数，我们可以维持什么样的份额。 我们再次认为我们会成为第一，但会有竞争对手。 然后患者停留在药物上多长时间，这就是我们在查看价格时所看到的，然后我们认为这是合理的。 您可以认为这远高于我们 - 回报将远高于我们的资本成本，我们看到后端股东的良好回报。
这是我们历史上最大的交易，80亿美元。 所以我认为你不应该期待你会看到那么频繁的频率。 但是，当我们看到一个巨大的资产，并且我们对它有信心时，我们认为我们可以创造价值。 我们将积极行动。
Yes. And in terms of the timelines for the drug so again, I think, you’ve said have some updated data later this year.
And then plans to file by year end that’s all on track?
Yes, everything is on track from we saw at the time we announced the acquisition, we expect to file by the end of the year. We will provide more mature data later this year. We haven’t announced the venue yet, but it’ll be at a medical meeting. And then with fast track and breakthrough designation that the drug has, we’d expect to launch in the first half of 2020.
是的，从我们宣布收购时看到的一切都在轨道上，我们希望在今年年底前提交。 我们将在今年晚些时候提供更成熟的数据。 我们还没有宣布会场，但它将在医疗会议上。 然后，凭借药物的快速跟踪和突破性指定，我们预计将在2020年上半年推出。
Okay. And you have the commercial infrastructure right now in place or is there anything more that you guys are doing to kind of perhaps build that market based on your current infrastructure?
Yes, the biggest thing that we’ll need to do, we do have, as a function of the acquisition lock, so had a sales force that they built that’s really focused on testing. That’s going to be the biggest piece here is driving, testing for this mutation. I think, if you are a patient who has an opportunity to get this drug, has lung cancer, or thyroid cancer, you’re going to want to be tested.
But that doesn’t exist today. So that’s the biggest commercial infrastructure piece that we’ll focus on. That’s not a significant investment, that’s a relatively small, but focused group that will do that.
是的，我们需要做的最重要的事情是，作为收购锁的一个功能，我们确实有一个他们建立的销售队伍，真正专注于测试。 这将成为最重要的一块是驾驶，测试这种突变。 我想，如果你是一个有机会得到这种药，患有肺癌或甲状腺癌的病人，你会想要接受检测。
但这在今天不存在。 这是我们将关注的最大的商业基础设施。 这不是一项重大的投资，这是一个相对较小但重点突出的团体，可以做到这一点。
And is there anything unique about this mutation versus EGFR, ALK, ROS that would say, okay, this is why it’s going to be either faster or slower than maybe some of the testing in those different models.
I think that we’ve looked at those the analogs, or I think what we find is if you have a drug that works against the mutation, the testing tends to follow. So we’re pretty – again it’s going to be execution, but we’re pretty confident that we’ll be able to drive good uptake here, again based on the strength of the drug and the opportunity for patients.
我认为我们已经看过那些类似物，或者我认为我们发现如果你有一种药物可以抵抗突变，那么测试往往会随之而来。 所以我们很漂亮 - 再次它会被执行，但我们相信我们能够在这里推动良好的吸收，再次基于药物的强度和患者的机会。
Okay, great. Maybe just moving on, drug pricing obviously there’s been a number of proposed changes here in the U.S. Maybe just would welcome your thoughts in terms of where you expect this to land over the forward here? Do you think we’re going to move away from a rebate system in the U.S.? And then how do you think if at all, you need to adapt your business model to that new norm?
好，太棒了。 也许只是继续前进，药物定价显然在美国有一些提议的变化可能只是欢迎你的想法，你期望这在这里落在前锋？ 你认为我们是否会放弃美国的退税制度？ 那你怎么想？如果有的话，你需要让你的商业模式适应新的规范吗？
I think first we think we should move away from a rebate model. That’s our starting point. I think the compounding effect, I think, of competition, consolidation on the payer side, which drives more price competition, and the growth of high deductible plans and things like that. I think the exposed to high – out-of-pocket cost and it’s pretty variable. And so I think, getting to a – resetting to a net price system, I think, is good for everybody, certainly going to be good for patients. I think it’s better for the industry and it’s better for anybody who touches cost, or drugs, or anything else. So we think that should happen.
Now in terms of when it will happen. We’ve advocated for the rebate rule. I think the timing piece is, I think, it changes every day in terms of the probability that it will go into effect in 2020. That’s our base operating assumption though that it will. So as we’ve provided Medicare Part D bids to our payer customers, we’ve done both the normal bid, as well as a net price bid. So we’re prepared for that to go into effect in 2020. We think that that’s an important first step and can help to reset sort of the environment longer term.
I think in terms of changes to the business model, hopefully some of the things that we would see we’ve already started to do. And I think if you look at the most recent launches of our new drugs, we’ve tried to price at list prices that are more representative of what we think the net price should be. I think Olumiant is probably the best example in the U.S. was launched it about 60% difference to the existing therapies, which I think historically you wouldn’t have done once a very high price and discounted down. So I think that’s one.
The thing for us that’s most important from business model perspective is driving volume growth. I think driving volume growth is going to win in any of these scenarios going forward. We’re in the fortunate position right now of having relatively new drug launches in big and growing categories. So that’s really what we’re focused on.
And then in terms of the rebate rule changes, maybe anything – I know it seems like Taltz maybe would be a beneficiary of that. May be talk to us about why that is. And then on the flip side and diabetes, any nuances there in terms of how to think about those changes in where you might have an impact in the portfolio?
然后就回扣规则的变化，也许是任何事情 - 我知道Taltz似乎可能会成为受益者。 可以跟我们谈谈为什么会这样。 然后就另一方面和糖尿病而言，在如何考虑可能对投资组合产生影响的那些变化方面存在任何细微差别？
Yes, I think from a rebate perspective where we see the most challenge is with our portfolio is in immunology as we’ve launched Taltz or IL-17 for psoriasis and psoriatic arthritis and Olumiant for rheumatoid arthritis. I think the established opportunity that Humira has and the amount of rebates for a drug of that size, that covers so many indications, we find it hard to sort of break through that. So in many cases, even though we think Taltz is the right first line age it’s used behind a TNF. Again for lots of historical reasons, we don’t think that’s the right thing for patients.
So I think if you’re in a more of a net price system, we think we have a better opportunity on an indication by indication basis to compete based on the sort of the net price of the drug and the merits of the indication, or the data. So that is something we certainly would see an opportunity there. I think that sort of plays out almost in any new innovation, right. If you don’t have the challenge of having to break through the legacy of repeats and other things that exist now.
So of course on the diabetes side we have that, because in many cases, where that’s to be established player. but I think what we see on the diabetes side that because of the intense competition in almost every class we’re in, the difference between list price and net price is pretty significant. So, when a patient shows up at the pharmacy counter, who is in the high deductible phase of their plan or for some other reason they don’t have insurance are exposed the list price, that’s a significant hardship for patients, that’s not what we intend. We’re pricing our drugs for our biggest customers. right now, that does lead in diabetes to big spread.
So, reset here, we think would be good for patients. And probably, this is a place, where just the number of patients, who are exposed to your diabetes is one of these classes. It’s one of the most challenging dynamics that we see. So, I think this would be an important – an important benefit for patients. And I think would help, I think from a broader perspective to maybe take some of the pressure off. Again, if you have a patient, who shows up and can’t afford their insulin and doesn’t take it, that’s a terrible outcome and it is very difficult to sort of manage through that now, resetting the price environment would help.
因此，重置在这里，我们认为对患者有益。而且，这可能是一个地方，只有接触过糖尿病的患者数量才是这些类别中的一个。这是我们看到的最具挑战性的动态之一。所以，我认为这将是一个重要的 - 对患者来说是一个重要的好处。我认为会有所帮助，我认为从更广泛的角度来看，可能会减轻一些压力。再说一次，如果你有一个患者，谁出现并且负担不起胰岛素并且不服用它，这是一个可怕的结果，现在很难管理，重置价格环境会有所帮助。
And what about in terms of sort of this Part D specifically, what’s your expectation for impact on the commercial market? Do you expect that would follow and maybe how slowly or quickly?
I think from our perspective, again, we’re just sort of speculating here, but what we’ve seen in other cases is the Medicare Part D, I mean it’s only been 10 years or so, but tends to help set direction, right? So, without any other legislative changes or regulatory changes, we would expect that probably over the course of the next couple of years, you’d sort of see a convergence in commercial and the Medicare Part D toward a net price system. I get, I’m sure other companies may have different perspectives. The PBMs or others, but I think we may have some of them at their conference here. They may have a different view. That’s sort of our view though just from what we’ve seen, play out over time that, if it happens in 2020 in Medicare probably over the course of the bidding cycles for commercial, so a couple of years we’d probably try to move things towards, I think it’d be very hard to manage two different systems long-term.
我认为，从我们的角度来看，我们在这里只是猜测，但我们在其他情况下看到的是Medicare D部分，我的意思是它只有10年左右，但往往有助于确定方向，对？ 因此，在没有任何其他立法变更或监管变化的情况下，我们预计可能在未来几年内，您会看到商业和医疗保险D部分向净价系统的趋同。 我知道，我相信其他公司可能会有不同的观点。 PBM或其他人，但我想我们可能会在他们的会议上有一些。 他们可能有不同的看法。 这是我们的观点，虽然只是从我们所看到的，随着时间的推移，如果它发生在2020年医疗保险可能在商业的招标周期的过程中，所以几年我们可能会尝试移动 事情朝向，我认为长期管理两个不同的系统是非常困难的。
Okay. Maybe, moving on another timely topic, ADA was, last weekend, you guys had a couple of important presentations there. Maybe, we’ll just start with the Trulicity REWIND data. Maybe just help us think about the key takeaways from your perspective, confidence level in the U.S. and European filing, and then the commercial impact. What do you really see this doing to the GLP market in terms of forward growth outlook?
好的。 也许，继续另一个及时的主题，ADA上周末，你们在那里做了几个重要的演讲。 也许，我们将从Trulicity REWIND数据开始。 也许只是帮助我们从您的角度考虑关键要点，美国和欧洲申请的信心水平，以及商业影响。 从前瞻性增长前景来看，您对GLP市场的看法是什么？
Sure. The REWIND trial, we are pleased with the outcome. It was a trial almost 10,000 patients and it was really designed to represent the broadest population possible for commercial opportunity in the diabetes – in a diabetes treating physician’s office. About 42% – if you look at the inclusion criteria for the trial, about 42% of the patients with diabetes show up have the inclusion factors.
So, it’s a very relevant trial to the prescribing physicians. the trial hit on its primary endpoint and based on the breadth of the data. We’re as confident as we could be in terms of the submission. Of course, as you work through the regulatory process, you don’t know until the end and we’d been surprised before, but I don’t know how we can be any more confident about the opportunity to get an indication that’s representative of the broad population patients with diabetes, who have cardiovascular risk factors. They don’t need to have had a cardiovascular event. We see that as the big differentiator versus other trials that have been run in the class.
So, we think this is going to be very relevant from a commercial perspective, because it’s a meaningful – it is the patients that treating physicians in the USC. So, we’ve submitted REWIND in Q1 and I would expect regulatory action in 2020 and then we will certainly educate and promote aggressively behind it. I think from an overall perspective, for us, from an overall company perspective, growth – continued growth in a GLP class is that things that we’re most focused on. We’re confident that Trulicity with its current profile and with new data will continue to do well from a share perspective. But of course, as you’ve alluded to, we’ve got tirzepatide coming. We want the GLP class to continue to grow at the 25% to 30% rate that we’ve seen for the last few years. We certainly think that’s – that’s a viable projection. The REWIND data certainly will help both in terms of the class growth, but also share preservation for Trulicity.
当然。 REWIND试验，我们对结果感到满意。这是一项近10,000名患者的试验，它的确旨在代表糖尿病治疗医师办公室中糖尿病商业机会最广泛的人群。大约42％ - 如果你看一下试验的纳入标准，大约42％的糖尿病患者出现了包含因素。
因此，我们认为从商业角度来看这将是非常相关的，因为它是有意义的 - 患者在南加州大学治疗医生。因此，我们在第一季度提交了REWIND，我希望在2020年采取监管措施，然后我们肯定会在其背后积极地进行教育和推广。从整体的角度来看，对于我们来说，从整体公司的角度来看，增长 - GLP课程的持续增长是我们最关注的事情。我们相信，Trulicity目前的个人资料和新数据将从分享的角度继续做得很好。但是，当然，正如你所提到的，我们已经有了tirzepatide。我们希望GLP类继续以我们在过去几年中看到的25％到30％的速度增长。我们当然认为那是 - 这是一个可行的预测。 REWIND数据无疑将有助于课堂成长，也可以为Trulicity分享保存。
And anything to think about is, I know, investors are trying to kind of compare across this trial versus some of the other CVOT studies. Anything there, any caveats or things we should think about as we kind of try to compare and contrast the different GLP studies?
Yes. I take first don’t – try to compare that. I think that’s the statistical answer, right? I mean they’re totally different patient populations, right? So, we designed the trial, said to really look at a broad swath of patients, who have risk factors. I think when we do compare the patient populations from the other CV trials in the GLP space, I think the big difference we see is 70% of the patients of the nearly 10,000 in the trial, had not had a prior MACE event and all the other trials with focus on patients secondary prevention patients had already had an event. So, from that standpoint, the patient population was completely different. They were different in other ways as well as the HbA1c, was in the sevens, where the other trials when you look at it just on average were more in the eights.
And then we studied for a longer period of time. We went out for five and a half years, where I think most of the other trials were in the two to three-year timeframe. I think when you look at the less sick population and the fact that it’s more heavily weighted to primary prevention. We also saw big differences in terms of a number of events in the trial. So, I think also when you look at how it was powered and statistical significance, you have to take into account the fact that this was a less sick population. So, they were going to be fewer events. So, you needed to – you’re going to see a different hazard ratio, just because of the population we’re studying. The thing we’re most excited about is it hit and we think it hit in a way that’ll get us a good label and indication.
是。我先拿不 - 尝试比较一下。我认为这是统计答案，对吧？我的意思是他们的患者群体完全不同，对吧？因此，我们设计了这项试验，据说真正关注一大批患有危险因素的患者。我想当我们比较GLP空间中其他CV试验的患者人群时，我认为我们看到的最大区别是试验中近10,000人的70％患者，没有事先的MACE事件和所有其他侧重于患者二级预防患者的试验已经发生过一次事件。因此，从这个角度来看，患者人群完全不同。他们在其他方面与HbA1c不同，在七人制中，其他试验，当你平均看到它时，更多的是8。
然后我们研究了更长的一段时间。我们出去了五年半，我认为大多数其他试验都在两到三年的时间内。我认为，当你看到病情较轻的人群以及它对一级预防更加重视的事实。我们还看到了试验中一些事件的巨大差异。因此，我认为当你看到它的动力和统计意义时，你必须考虑到这是一个病情较轻的人群。所以，他们将减少事件。所以，你需要 - 你会看到不同的风险比，只是因为我们正在研究的人口。我们最感兴趣的是它受到了打击，我们认为它的打击方式会让我们获得良好的标签和指示。
Okay. And where are you guys have focused a lot on first injection share? I think you said it’s about 50% right now. Where can that go over what timeframe and again, how important is this data to really driving that on the forward?
好的。 你们在哪里注重首次注射份额？ 我想你现在说它约占50％。 这可以追溯到什么时间框架，这些数据在前进中真正推动这一点有多重要？
Yes. I think so we’ve – if you look at total prescriptions now for first injections, it’s three out of 10 patients are getting a GLP versus a basal insulin in new prescriptions, it’s five or 10. So, it is moving, right? and a part of that, that certainly the launch, it was epic, has helped. So, having good weekly product helps. I think the recognition across classes not just in a GLPs of cardiovascular benefits is important. and certainly, the rewind data will play an important role here. I don’t think there’s any – I mean as we look at the data, sort of everybody was treated per guidelines and follows a progression in a logical way that that five out of 10 should be like nine out of 10 or something, right. So, we see lots of room for the class to continue to grow. I think given the growth rates in the 25% to 30% range to get up to the seven, eight, nine, nine out of 10 patients, that’s 25% to 30% growth for the next four or five years. It’s still, I think a logical way to look at this.
是。我想我们已经 - 如果你现在看一下第一次注射的总处方，那么10个患者中有3个在新处方中得到GLP而不是基础胰岛素，它是5或10个。所以，它正在移动，对吗？还有一部分，那当然是发射，它是史诗，有帮助。因此，拥有良好的每周产品有助于。我认为，不仅在心血管疾病的GLP中，各阶层的认可也很重要。当然，倒带数据将在这里发挥重要作用。我认为没有 - 我的意思是，当我们查看数据时，每个人都按照指导方针进行处理，并遵循一个合理的方式进展，即10个中的5个应该像9个中的9个或者其他，对。所以，我们看到课堂有很大的空间继续发展。我认为，考虑到25％到30％的增长率可以达到10个患者中的7个，8个，9个，9个，那么未来4到5年的增长率将达到25％到30％。它仍然是，我认为这是一个合乎逻辑的方式来看待这一点。
Okay. And one of the – before we get tirzepatide one of the other debates or some of GLPs, obviously, oral sema is expected to be launched later this year. So, as you think about that, and maybe, again, no it’s not your decision, but in terms of kind of price volume dynamics and the impact that that drug could have and you talked about the 20% to 30% growth, maybe just help us think about where – or you expect oral sema to kind of fit into that framework.
好的。 其中之一 - 在我们得到tirzepatide其他辩论或一些GLP之前，很明显，口头sema预计将在今年晚些时候推出。 所以，当你想到这一点，也许，再一次，不是不是你的决定，而是在价格体积动态和药物可能产生的影响方面，你谈到了20％到30％的增长，也许只是 帮助我们思考哪些 - 或者您希望口腔sema适合该框架。
Sure. Well, Terence as we said, I think that’s there are some interesting and difficult decisions I think for Novo here and I assume they’ll make good ones. So, I think what we would look at is first in the injectable GLP space is something that has got a lot of room for growth there. We know that physicians are going to want to try oral sema. And in some cases, we’ll try it instead of putting a patient that would have gone onto an injectable GLP. So that, that’ll be a little bit of a headwind in terms of class growth, but relative to the 25% to 30% that I was alluding to earlier, we think that’s a – that’s not going to all of a sudden cause GLPs to slow down to a big extent.
We think another place, certainly, it’ll also compete on an oral basis against SGLT2s and DPP-4s. Again, I think we look and say, there’s such an opportunity still for SGLT2s that even if you take a little bit of that volume away, you still got – we still feel really good about Jardiance. And I think frankly when we look at the data though the comparison to Jardiance in the PIONEER trial. Jardiance looks really good. So, we think competitively, we’re well positioned. But we do expect that there, you’ll see usage, you’re sort of across the spectrum, and again it’s not completely clear to us until we see how Novo chooses to position the drug. But for now, we sort of assume it’s going to carve off a little bit of volume from almost every area in diabetes and of course, if you’re in Novo shoes, it’s figuring out how do you position that, right? So, we’re sort of assuming it’s going to be a good drug, it’s going to get good uptake. but we’re going to focus on the big opportunities still left in GLP and SGLT2s for Jardiance.
当然。好吧，特伦斯正如我们所说，我认为我认为这里有一些有趣而艰难的决定，我认为他们会做出好的决定。所以，我认为我们在可注射GLP空间中首先看到的是那里有很大的增长空间。我们知道医生会想尝试口服血清。在某些情况下，我们会尝试而不是让患者进入可注射的GLP。所以，这对于阶级增长而言会有一点逆风，但相对于我之前提到的25％到30％，我们认为这是一个 - 这不会突然导致GLP在很大程度上放慢速度。
我们认为另一个地方，当然，它也将口头竞争SGLT2和DPP-4。再一次，我认为我们看起来并且说，SGLT2还有这样一个机会，即使你拿走一点这个音量，你仍然有 - 我们仍然觉得Jardiance真的很好。我坦率地说，当我们通过PIONEER试验中与Jardiance的比较来查看数据时。 Jardiance看起来非常好。所以，我们认为竞争激烈，我们处于有利地位。但是我们确实希望在那里，你会看到使用方式，你可能会在各个方面，而且在我们看到Novo选择如何定位药物之前，我们并不完全清楚。但就目前而言，我们有点假设它会从糖尿病的几乎每个区域开始减少一点体积，当然，如果你穿着Novo鞋子，它会弄清楚你是如何定位的，对吧？所以，我们有点假设它会成为一种好药，它会得到很好的吸收。但我们将重点关注GLP和SGLT2s为Jardiance留下的巨大机遇。
Okay. And I guess how disciplined would you guys be on the pricing side? Because I know that’s one of the other debates just as you move into the – again making GLPs a bigger category.
好的。 而且我猜你们在定价方面有多严谨？ 因为我知道这是其他辩论之一，就像你进入 - 再次使GLP成为一个更大的类别。
And again, maybe taking share from some of these older generic drugs. I mean where are you guys on the kind of pricing side?
We think that GLPs are priced appropriately for the value they bring to the healthcare system at ADA. One of the things we showed was a sort of cost effectiveness and what it costs to reduce HbA1c relative to basal insulin, then the comparison looks really good. So we will be, I think very disciplined and trying to preserve appropriate value that we think exists today. Given the – our perspective here is physicians and patients should have ability to choose different drugs in some cases, whether it’s oral sema or Ozempic. It’s going to be a better choice than trulicity. We’re confident in Trulicity’s profile as a product and the benefits that it brings to patients in terms of the device and otherwise.
So, we don’t want to be in a position, where we’re trying to trade price to get share. Trulicity is going to get plenty of share if we can keep the class open and available. So, I think the decisions around oral sema pricing, we don’t see that as a major event. It’s not going to be something that we’re going to try to proactively do anything around.
我们认为GLP的价格适合他们为ADA医疗保健系统带来的价值。我们展示的一件事是成本效益和降低HbA1c相对于基础胰岛素的成本，然后比较看起来非常好。所以我们会这样，我认为非常自律，并试图保持我们今天认为存在的适当价值。鉴于 - 我们的观点是医生和患者应该有能力在某些情况下选择不同的药物，无论是口服sema还是Ozempic。这将是一个比真正的更好的选择。我们对Trulicity作为产品的形象以及它在设备方面带给患者的好处充满信心。
Okay. maybe, tirzepatide, obviously an important pipeline program for you guys, had some new data. Maybe, just remind us what was the aim of this phase II titration study and then in your view, did you achieve the aims that you set out to, I think…
好的。 也许，tirzepatide，显然是一个重要的管道程序给你们，有一些新的数据。 也许，只是提醒我们这个II期滴定研究的目的是什么，然后在你看来，你是否达到了你所设定的目标，我想......
Sure. Yes. So, last year at EASD, we released the data from our core phase II trials for tirzepatide. And I think what we saw is across a range of doses, really impressive performance in terms of HbA1c and weight loss. I think when you got up to the 15 mg are the highest dose that was tested in phase II. the concern was could patients tolerate it. And then the phase II study that we did, we got them up to 15 mg very, very quickly. And what we saw was about a 34% – 32% dropout rate and that’s not practical.
So, what we needed to do before we started into phase III was to figure out and the doses up to 15 mg, we saw reasonable discontinuation rates, reasonable compared Trulicity trials and other things. So what we wanted to do before we started the Phase III program was to figure out a more reasonable dosing titration system that could allow patients to get to 15 mg without that kind of discontinuation rate.
So the titration study was done to inform that Phase III dosing protocol and we certainly think we achieved what we set out to do and that was to inform the Phase III piece. I think if you look at that, we have three different titration schemes that we laid out in the dose – in the titration study. And then the one that where we went a little bit slower to get to 15 mg, you saw that 32% number in the Phase II trial come down to about 7% in the titration study, which is I think in line with what we’ve seen in other GLP studies.
We think we can do better than that, so this was just to inform the Phase III protocol decision. We’ve looked at that data, we’ve looked at the Phase – the core Phase II data and based on our modeling then have chosen an even slower progression in Phase III, so to get to 15 mg patients will progress starting with a 2.5 mg dose every four weeks up to 15 mg. So we think we can do better than the 7%, but we think that was – the main goal was to say, is there a titration approach that can get the full benefits of the 15 mg without a third of the patients dropping out.
因此，滴定研究是为了告知第三阶段给药方案，我们当然认为我们已经实现了我们的目标，那就是通知第三阶段。我想如果你看一下，我们有三种不同的滴定方案，我们在剂量中列出 - 在滴定研究中。然后我们在那里慢慢达到15毫克的那个，你看到II期试验中32％的数量在滴定研究中下降到约7％，我认为这符合我们的'在其他GLP研究中见过。
我们认为我们可以做得更好，所以这只是为了通知第三阶段协议的决定。我们已经查看了这些数据，我们查看了阶段 - 核心阶段II数据，并根据我们的建模，然后在第三阶段选择了更慢的进展，因此从2.5开始，达到15毫克的患者将取得进展每四周服用mg剂量至15毫克。因此我们认为我们可以比7％做得更好，但我们认为 - 主要目标是，是否有一种滴定方法可以获得15毫克的全部益处，而不会有三分之一的患者退出。
Okay. And I think one of the other questions has been, how easy would it be for patients to kind of implement the titration schedule assuming you get to market?
Yes. We think it will be easy. We’re using the Trulicity device, the pen for Trulicity and basically you’d get the pen at same presentation each time, so it’d be no dialing of dose or anything, so you’d get your first month, 2.5 mg, you’d go back to the pharmacy when require physician titration or anything like this, it’s a pretty straightforward thing, the pen would look the same to the patients. So we think this is not only doable in a clinical trial but practical in the real world.
是。 我们认为这很容易。 我们正在使用Trulicity设备，用于Trulicity的笔，基本上你每次都会得到相同的演示笔，因此它不会拨打剂量或任何东西，所以你得到你的第一个月，2.5毫克， 当你需要医生滴定或类似的东西时，你会回到药房，这是一个非常简单的事情，笔对患者看起来是一样的。 因此，我们认为这不仅在临床试验中可行，而且在现实世界中也是可行的。
Okay. And then remind us in terms of you’ve got a broad Phase III program, I think you kicked off in December, so maybe just what’s the cadence of kind of data readouts and regulatory filings? Like, where the next things we should look for?
好的。 然后提醒我们，你有一个广泛的第三阶段计划，我想你在12月开始，所以也许只是数据读数和监管文件的节奏是什么？ 比如，我们应该寻找下一件事情？
The next things you should look for, as it relates to the type two diabetes program in Phase III will be our – the trials will start to readout in 2021. So 2021 and 2022 is when the data will come together for submission. And again, what we’re really looking at is replicating the Phase II efficacy and wade with better tolerability, which we feel good about. We also then are – later this year kicking off a separate Phase III program with tirzepatide for obesity as a standalone indication. And again, based on the weight loss data we saw in the Phase II trial, we are pretty excited about that opportunity. We also will commence a Phase II NASH study. Again based on the data we see not just weight loss but some of the biomarker data we see that gives us some good confidence that we would have at a good NASH opportunity here. And we’re following the protocol established by the FDA. We’ll do a Phase II study with biopsy and presumably move into Phase III from there.
你应该寻找的下一件事，因为它与第三阶段的二型糖尿病计划有关，将是我们的 - 试验将在2021年开始读出。所以2021年和2022年是数据汇集在一起提交。 而且，我们真正关注的是复制第二阶段的功效和涉及更好的耐受性，这是我们感觉良好的。 我们当时也是 - 今年晚些时候开始一个单独的III期计划与tirzepatide肥胖作为一个独立的指示。 再次，根据我们在第二阶段试验中看到的减肥数据，我们对这个机会感到非常兴奋。 我们还将开始第二期NASH研究。 再次基于数据，我们不仅看到减肥，而且我们看到的一些生物标志物数据给了我们一些很好的信心，我们将在这里获得良好的NASH机会。 我们遵循FDA制定的协议。 我们将进行活检的II期研究，并可能从那里进入第三阶段。
And how much work have you guys done there on the commercial side in terms of the NASH market, because I know that’s a market, there’s a lot of debate in terms of kind of the addressable market size, amount of diagnosis that has to happen to really build that. So where are you guys in kind of that discussion in terms of thinking about the commercial opportunity on NASH side?
你们在NASH市场的商业方面做了多少工作，因为我知道这是一个市场，在可寻址的市场规模，必须发生的诊断数量方面存在很多争论。 真的建立了。 那么在考虑NASH方面的商业机会方面，你们在哪些方面进行讨论？
I think we have been cautious on NASH up until now, because I think some of the other drugs that we’ve looked at externally wasn’t clear to us, what that commercial opportunity would look like. I think with what we see with tirzepatide and our assumption, we think we can hit a pretty significant market. I think our estimates are about 16 million patients probably in the U.S. have NASH and there should be some function – some subset of that tirzepatide would be appropriate for, but it’s a pretty significant number.
And again, I think what we’re looking at is, we know weight loss contributes I think the other metabolic impacts, we think there’s something here that’s meaningful that would be compelling for physicians to want to treat patients, I think our question has been, if NASH really something that physicians are going to treat and it’s most sort of prevalent form, I think with tirzepatide, if we’re able to replicate the data we see in Phase II, we think it becomes a compelling commercial opportunity.
我认为到目前为止我们一直对NASH持谨慎态度，因为我认为我们从外部看过的其他一些药物对我们来说并不清楚，那商业机会会是什么样子。我认为，通过tirzepatide和我们的假设，我们认为我们可以进入一个非常重要的市场。我认为我们估计大约有1600万患者可能在美国有NASH，并且应该有一些功能 - tirzepatide的某些子集适合，但这是一个非常重要的数字。
Okay. And you think that alone is enough or do you think like combination opportunity, I know somebody else some other companies have talked about, like I know nobody did a partnership with Gilead for some combination approaches.
Again, we’re going to learn from the Phase II study, but we think there’s a compelling probably standalone opportunity.
Okay, great. Maybe moving onto one of your other new product cycles Emgality, maybe just walk us through where access stands right now? And then what should we look for in terms of the free drug program? I know that’s something else that, again, there’s been transition going on there. So if we think about the kind of forward metrics, where are we at?
好，太棒了。 也许转到你的其他新产品周期Emgality，也许只是带我们走过现在的访问站点？ 然后我们应该在免费药物计划方面寻找什么？ 我知道那是另一回事，那里已经发生了转变。 因此，如果我们考虑前瞻性指标的类型，我们在哪里？
Yes. We’re really excited about the long-term opportunity in migraine. When we look today at patient access, it’s about 80%. So about 80% of patients who would present for Emgality would have coverage through their PBM or insurance plan through a really pretty limited, I mean, pretty straightforward PA process, in most cases it is an electronic attestation that says they’ve tried some other preventative therapy in the past one or two in some cases. So that’s pretty straight forward, so 80%.
Now what – we’re not seeing 80% today in terms of reimbursed prescriptions. We said in Q1 that the number, the average was about 50%, a little bit over 50%. That is just the – it’s just the time it’s taken from agreeing on formulary status to that getting all the way pushed through the system down to the whatever the relevant sort of regional unit plan is. We think that’s all pretty much in place by April. So you should expect to see a number. We even said on our Q1 call that by the end of the quarter, we were seeing about two-thirds of the prescriptions being reimbursed. Again, that number over time should get up to 80%, and it should be at 80% in the sort of Q3 timeframe.
We still though, our approach is to make this really easy for physicians and patients to get Emgality. So the first month of dose is generally given in the office as a sample. So that doesn’t show up as a prescription. And then you’ve got 30 days to go through that electronic attestation process and everything else. So, we expect that you’ll start to see the cumulative effect of the access decisions and the volume growth that we continue to see. We’re pleased with the in-market performance, we’ve taken first place in terms of new to brand share.
And I think now the play is to drive volume growth, there are 6 million patients we think that are eligible for preventative medicine in migraine and at least 3 million of them have taken medications in the past. So that’s our goals to drive those patients into the office asking for a new therapy. And that’s why you watch TV, you see lots of DTC ads from all three companies really here, so.
现在是什么 - 我们今天没有看到80％的报销处方。我们在第一季度说这个数字，平均值约为50％，略高于50％。这就是 - 只是从处方集状态达成一致的时间到将系统推进到相关的区域单位计划的所有方式。我们认为到4月份这一切都已到位。所以你应该期待看到一个数字。我们甚至在第一季度的电话会议上说，截至本季度末，我们看到约有三分之二的处方报销。同样，随着时间的推移，这个数字应该达到80％，并且在Q3时间范围内应该达到80％。
And what in terms of I guess the volumes where you’ve seen that come from now primarily, is it a mix of kind of the specialist, the primary care guys, or is there a mix shift happening?
And then where do you think you can – in terms of like market share, I mean, is your goal – obviously you want to have the most market share, but do you think ultimately it settles out where there’s some kind of even distribution or do you see advantages on your drug profile that could give you majority market share?
然后你认为你可以在哪里 - 就像市场份额一样，我的意思是，你的目标 - 显然你想拥有最大的市场份额，但你认为它最终会解决哪里有某种均匀的分布或做什么 你看到你的药物资料的优势可以给你多数市场份额？
So I think first in terms of where is volume coming from, we did see a bolus in specialist office right away, patients who coming in and had been treated and not responding well. So that’s where the initial uptake I think was. But long-term and what we’re seeing now, more than half of the prescription should come out off the primary care setting. We think we’re really well positioned in primary care. In fact, when we look at prescribing physician targets about – there’s about a 70% overlap with our Trulicity targets and the other benefit that we see here is, it’s the device for Emgality is the same as a device for Trulicity, so physicians have competence there. But yes, I do think that for the – to see the kind of growth that we would expect in the class, you’re going to see the majority of that growth in the future coming out of the – more of the primary care, setting and that’s where we’re focused.
What we’re hearing from physicians and particularly specialists who have more experience now is, they think all three drugs are good and they’re choosing the drugs based on the margins, what do they see in terms of ease-of-use for patients, ease-of-use for the access programs and side effects? I think I have to say that we think Emgality is going to be the best drug and it’s not going to be a third, third, third. We do think there are some benefits, again starting with our presence and capabilities in the primary care office. We also have a while not for migraine, but we have a related indication the other two don’t for cluster headache, which is a terrible condition, now that’s going to be in the specialist setting. But we’re very pleased with that indications can bring a big benefit to patients and certainly reinforces our commitment to headache basically in the space.
And then we’ll launch our acute migraine drug lasmiditan presumably next year. And I think that brings again back to what our physicians looking at sort of full suite of products and services that we can bring.
所以我首先想到的是体积来自何处，我们确实看到了专家办公室立即推出，患者进入并接受治疗且反应不佳。所以这就是我认为最初采用的地方。但是长期以及我们现在所看到的，超过一半的处方应该从初级保健机构中脱颖而出。我们认为我们在初级保健方面的定位非常好。事实上，当我们看到处方医师的目标 - 与我们的Trulicity目标有大约70％的重叠，而我们在这里看到的另一个好处是，Emgality的设备与Trulicity的设备相同，因此医生有能力那里。但是，是的，我确实认为 - 为了看到我们在课堂上期望的那种增长，你会看到未来的大部分增长来自 - 更多的初级保健，设定这就是我们关注的地方。
Great. Maybe just in the last couple of minutes, we just love your outlook and kind of the margin structure. Obviously, you guys post the Elanco spin, put some targets out there, executing against those growing the top line. But how should we think about the evolution of the margin structure now that you’re more of a pure biopharma company?
非常好。 也许只是在最后几分钟，我们只是喜欢你的前景和保证金结构。 显然，你们发布了Elanco旋转，将一些目标放在那里，对那些增长顶线的人执行。 但是，如果你更像是一家纯粹的生物制药公司，我们应该怎样考虑保证金结构的演变？
Yes. So our goal – our target for 2020 is to have operating margin of 31%. We’re confident we’re on track for that, you’ve seen year-over-year margin expansion since we’ve come out of our YZ period. We’ve used 2020, just because that’s sort of the time window that we gave some mid-term guidance around. We expect to see ongoing year-over-year margin expansion really as a function of our sales line continuing to scale on the products that we’ve already launched. So every incremental dollar of sales that we think of in the next few years of most of those incremental dollars are going to come from products like Trulicity or Emgality or Taltz, where we already have a fixed investment in infrastructure.
So it’s certainly from our perspective, we’d expect to see year-over-year margin expansion. I think one of the things that’s unique for Lilly and our history and I think unique across the industries is as we look in the decade of the 2020s, we have very limited patent exposure. So which tends to cause the sort of the dips in margin and that’s why we’re still building our way out of our generic events from the middle of the decade. We don’t see that to any large degree in the 2020. So if we execute on the sales opportunities that we see in front of us, we’ll continue to invest in R&D, but we’ll get margin expansion as a function of that.
是。所以我们的目标 - 我们2020年的目标是拥有31％的营业利润率。我们相信我们正在走上正轨，自从我们走出YZ时期以来，您已经看到了同比增长的利润率。我们使用了2020年，只是因为那是我们提供一些中期指导的时间窗口。我们预计，随着我们的销售线继续按照我们已经推出的产品进行扩展，我们将实现持续的同比增长。因此，我们认为未来几年大部分增量美元的销售额每增加一美元将来自Trulicity或Emgality或Taltz等产品，我们已经对基础设施进行了固定投资。
Maybe last one, how should we think about longer-term targets? Again, I mean, there’s obviously a reason why you gave you those targets at the time you did. But is that something we should think about again, or is it too early to…
也许最后一个，我们应该如何考虑长期目标？ 我的意思是，在你做的时候，显然有一个原因可以解释你为什么给这些目标。 但这是我们应该再考虑一下，还是为时过早......
In 2020, we’ll – yes, what we’re going to focus on is achieving the 2020 goals. In 2020, we’ll look and say, is there value to give investors another set of targets. I think there’s value when there is a difference between what we see and what we think investors are saying, so we’ll have to assess that at that time. I think the one thing you can certainly takeaways your prior question. We’re going to stay focused on margins, not at the expense of R&D investment, but just as a function of running the business and growing the business like we think we can.
在2020年，我们 - 是的，我们将关注的是实现2020年的目标。 在2020年，我们会看到并说，为投资者提供另一套目标是否有价值。 我认为当我们看到的和我们认为的投资者所说的内容之间存在差异时，我认为这是有价值的，因此我们当时必须对此进行评估。 我认为你可以肯定地接受先前的问题。 我们将继续专注于利润率，而不是以研发投资为代价，而只是作为运营业务和发展业务的功能，就像我们认为的那样。
Yes. Great. Well, thanks so much Josh. I appreciate it.
是。 大。 好吧，非常感谢乔希。 我很感激。
Thank you, Terence. Thank you. Thanks.
谢谢你，特伦斯。 谢谢。 谢谢。
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