My name is DeMarcus Ross, and I will be your conference facilitator today for Amgen's second quarter 2016 earnings conference call. All lines have been placed on mute to prevent any background noise. There will be a question-and-answer session at the conclusion of the last speaker's prepared remarks. In order to ensure that everyone has a chance to participate, we would like to request you to limit yourself to asking one question during the Q&A session. I would now like to introduce Arvind Sood, Vice President of Investor Relations. Mr. Sood, you may now begin.

Thank you, DeMarcus. Good afternoon, everybody. So I'd like to welcome you to our conference call to discuss our second quarter financial results. I would like to particularly extend a warm welcome to those who are new in their investment coverage of Amgen, including Ronny Gal and Vincent Chen of Bernstein. Our second quarter once again is a continuation of great execution of how we are effectively managing the life cycle of legacy products while launching new products. Of course, there's much more to our execution. So to have the broader discussion, I'm joined today by Bob Bradway, our Chairman and CEO, who will lead the call with a strategic overview. Our CFO, David Meline, will then review our quarterly results and update you on our guidance for 2016. Following David, our Head of Global Commercial Operations, Tony Hooper, will discuss our product performance during the quarter, followed by our Head of R&D, Sean Harper, who will provide a pipeline update. We should have plenty of time for Q&A after Sean's comments. So before I turn the call over to Bob, I would like to note that we have reviewed the Securities and Exchange Commission's recent guidance regarding the use of non-GAAP financial measures, and our press release incorporates this revised guidance. As in the past, we will use slides for our presentation today, which have been posted on our website, and a link was sent to you separately by email. We plan on using non-GAAP financial measures in today's presentation to provide information which may be useful to understanding our ongoing business performance. However, these non-GAAP financial measures should be considered together with GAAP results, and reconciliations of these measures are available in the schedules accompanying today's press release on Form 8-K and also on the Investor Relations section…

Thanks, David. You'll find a summary of our sales performance for the second quarter on slide number 10. We continued our strong performance in the second quarter, with global product sales growing 5% year over year. Our U.S. business delivered 5% year-over-year growth, and our international business grew 3%, or 5% year over year excluding the impact of foreign exchange. Europe was a strong contributor, with 11% unit growth. My comments will be in three parts today: first, the performance of our growth products; followed by an update of our life cycle management of the mature brands; and then I'll conclude with highlights on the performance of our newly launched products. Our six growth products, Prolia, XGEVA, ENBREL, Sensipar, Vectibix, and Nplate, continue to drive our overall performance with 13% year-over-year growth. As David said, they aggregated to $3 billion of sales, or over 50% of second quarter sales. We continue our investments in these brands to achieve their full potential. Both Prolia and XGEVA are now annualizing at over $3 billion per year. Prolia grew 30% year over year with a 24% unit growth and continued share gains in both the U.S. and Europe. Post-menopausal osteoporosis remains a widely untreated disease. In the U.S. alone, 10 million people are affected, and 4.5 million of those are considered at high risk of fracture. Unfortunately, nearly 60% of these patients are not treated. We are investing in Prolia to reach these under-served patients and also to remind current Prolia patients about the importance of returning every six months for their treatment. XGEVA saw a 15% year-over-year growth, driven by unit share gains of around two percentage points in both the U.S. and Europe. Quarter-over-quarter growth was negatively impacted by heavier purchasing from some larger end customers in the U.S. during the…

Absolutely. Your first question comes from the line of Terence Flynn with Goldman Sachs. Terence Flynn - Goldman Sachs & Co.: Hi, thanks for taking the questions, maybe two for me. Just first on the COGS, pretty impressive versus a year ago, just wondering if that level is sustainable longer term. And then on Repatha, Sean, can you remind us what you want to see out of the IVUS trial and if there's any potential read-through to the outcomes data coming next year? Thank you. Robert A. Bradway - Chairman, President & Chief Executive Officer: Okay, Terence, we'll try and take those in two parts. I'll ask David to speak first about the question about COGS, and then Sean can talk about Repatha. But big picture, as you know, we've been working towards improving the efficiency and productivity of our manufacturing organization for some time. You've heard us say before, Terence, we think manufacturing is a source of competitive advantage for Amgen, and we're excited about what we've achieved to-date and where we're going next with the introduction of our next-generation bio-manufacturing. So generally the trend is positive. You see that reflected in the quarter. And, David, do you want to provide any more specific guidance on that? David W. Meline - Chief Financial Officer & Executive Vice President: No, very much the same, Bob. So what we're seeing is, as you would know, we consolidated our manufacturing activity to try to improve the efficiency, and you're now seeing that coming through into the results. So I would say through time, we'll seek to maintain our cost of sales at that very competitive level, recognizing there will be some pressure on us in terms of the cost of sales as we introduce the new portfolio. But we think it's a…

Your next question comes from the line of Eric Schmidt with Cowen & Company. Eric Schmidt - Cowen & Co. LLC: Congrats on a really solid quarter, maybe a couple quick ones for Tony. Can you talk about the impact that Darzalex is having on Kyprolis? It does look like from the monthly IMS data that we get that there's been a little competitive impact there. And then second, I was surprised to see that Amgen is branching out into the ultra-orphan space, at least with an eculizumab biosimilar. Can you talk about how that program might fit commercially with your current capabilities?

Okay, thanks, Eric. As you know, the data inside the multiple myeloma market is a bit more complicated to try and segment between first, second and third-line plus, and we often have to use chart orders for that. Based on the data we've seen, Darzalex is clearly a good product, but we truly see the combination potentially of this product and Kyprolis as a future regimen in treating multiple myeloma. Most of the usage we've seen with Darzalex at the moment is fourth-line plus, however. To your question on our new biosimilar opportunity, I think Amgen has specialized for many years in specialty drugs with a focus target population, with low resources required to get to prescribers and to identify patients. So I think that one fits quite well with our model.

Your next question comes from the line of Matthew Harrison with Morgan Stanley. Matthew K. Harrison - Morgan Stanley & Co. LLC: Great, thanks for taking the question. If I could ask, just maybe if you could, comment broadly on biosimilars. You've got three that are at regulatory submission or in regulatory submission. Could you just walk through what your thoughts are around when you might be able to launch those products, some of the remaining legal hurdles that you're going to have to get through, and how you see that revenue stream developing over the next year or two? Thanks. Robert A. Bradway - Chairman, President & Chief Executive Officer: Matthew, a couple things. First, as you know, we have some nine programs that are under development. Over time, we think those could be an important source of growth and revenue opportunity for us at Amgen. We think that our commitment to developing these biosimilars reflects our belief. The capabilities we have established for our innovative business will lend themselves well to developing a branded biosimilar portfolio as well. The next step for us on the three that are in advanced regulatory stages is the same path for each of the three. It starts with needing to get regulatory approval. So we hope and expect that we'll have an opportunity to get regulatory approval for our first, which is the biosimilar Humira, later this year. And with the benefit of that then, with that approval in hand, we'll turn to the questions of commercialization, as we will for the other two. So first thing we need to do is get approvals, and that's what we're working on securing right now. As to your question about revenue profile and what we're going do when the approvals are in hand, we'll wait and comment on those issues at the appropriate time, Matthew.

Your next question comes from the line of Geoff Meacham with Barclays.

Good afternoon, guys, thanks for taking the question. Sean, I have a couple for you on erenumab. The first one, for the chronic migraine data last month, how would you view the baseline migraine data relative to – just put that in context with the real world? Second point, as we look forward to the episodic data, obviously a more variable population. Maybe help us with how you'd characterize a result as being clinically meaningful in this population. Thanks. Sean E. Harper - Executive Vice President-Research & Development: Sure. I think when we look at the data from the chronic migraine study, it appears to us as though we have enrolled there a very representative population of this type of afflicted group. And as you know, these people are suffering with just an unimaginable number of these headaches per month. As we talk to the experts in the field, it seems that the population that we enrolled there in terms of the baseline level of headache and the kind of response that we saw in comparison to other product candidates in this axis are all as we might have expected. In the episodic migraine setting, of course, the baseline number of headache days are by definition less, but the treatment effect is still quite robust and reproducible, and I think that's been the case. It's within the world of neuroscience products, quite remarkable when you look at the data across the small molecules that have been entered in this space, the ligand-sequestering antibodies and erenumab that you see a remarkably consistent treatment effect. One comment I'd make is that it's the case that this treatment effect is robust, it's reproducible, but there also is quite a large placebo effect that patients get that comes along with the treatment effect, and it's durable over a long period of time. This is actually what the patient experiences, which is not unique to neuroscience but it's particularly potent in this setting. It's a little hard to get your mind around that sometimes, but this is what people who actually care for these patients emphasize to us to when we look at the data.

Your next question comes from the line of Alethia Young with Credit Suisse. Alethia Young - Credit Suisse Securities (USA) LLC (Broker): Hey, guys. Thanks for taking my question. Congrats on the quarter. One, can you give us a little bit more color on the timing around biosimilar eculizumab data that's the study in New Zealand? And then also on a second point, can you just frame for us how you think about some of the competitors in the migraine space and how your drug may stack up? Is it a matter of differentiation or is it just a commercial battle in your mind? Robert A. Bradway - Chairman, President & Chief Executive Officer: Okay, a couple different questions here. We'll start with the migraine question, Sean, then we'll talk about the field. Sean E. Harper - Executive Vice President-Research & Development: What I would say again, and I just made this comment that when you look at what's gone on where mainly companies that have been driving for proof-of-concept and/or dose-ranging their products, they've used doses of either small molecules, ligand-sequestering antibody or receptor antibodies in our case that are saturating the system. And when that happens, that's how across all these different studies across different companies and so on, you're seeing a very consistent result because you're maxing out the impact that inhibiting CGRP can have in migraine. So that's nice to see. And then really it comes down to the question of what is the minimal dose that's effective in achieving that effect. And I think then the devil gets into the details really around the issue of how easily administrable is that particular amount of antibody. So there's going to be a certain milligram amount of antibody that has to be administered. Let's say we believe a monthly subcutaneous disposable auto-injector would be a very nice solution to this otherwise healthy active type of population. And I think that others of course are pursuing strategies that are different than that, and I think it will be interesting, obviously, to see how that all plays out. Tony, you could comment. But I think scientifically, I've not seen any data to suggest that these products are different from one another with respect to what they can achieve when they are dosed and saturating quantity.

Sure. So we've seen the good clinical data, and I think there will be clearly a need for a good marketing plan, a good strategy, a good share of voice, and understanding what makes patients move to request this type of medication. The market is hugely unmet at the moment. There's a large amount of patients who are clamoring consistently and looking for help to try and treat this terrible disease. So it's a combination of both clinical science and a good strategy. Robert A. Bradway - Chairman, President & Chief Executive Officer: With respect to your biosimilar question, Alethia, we've disclosed that we've begun the program, and that's all we're disclosing at this point.

Your next question comes from the line of Michael Yee with RBC Capital Markets.

Hi, good afternoon, a question on Parsabiv, which has a PDUFA date. The Sensipar franchise is over $1 billion. Can you just remind us how to think about the new product versus the loss of exclusivity period for Sensipar? If there's a swapping, how do we think about that line item as that product comes on? And then to follow up on Repatha, can you remind us how much usage is once-monthly now? I assume it's small. But what do you expect that to be over time, once monthly? Thanks. Robert A. Bradway - Chairman, President & Chief Executive Officer: Michael, we're having a little trouble hearing you, but I think you had two questions that Tony can address, the first about Parsabiv, which, as you know, is the subject of a PDUFA date later this summer. And then with respect to the once-monthly Repatha, I think that's the question Michael was asking.

So let's start with the Parsabiv question. As you know, Sensipar has been extremely successful in treating patients both in the U.S. and around the world. But in spite of the efficacy of Sensipar, we probably only have about a 26% penetration. Compliance or patient persistency in this particular market is always an issue to ensure patients who are on dialysis three times a week actually take their tablets every day as well. Parsabiv brings a combination of potentially a better level of persistency because you'll be infused while you're having your dialysis. But the second thing is, as you've seen from the clinical data, in fact, there appear to be a much more robust level of efficacy of Parsabiv. CMS have granted us a two-year period that this product will exist outside the bundle while they determine the medical value, to determine the value of putting it back in the bundle. So we continue to be excited about the product. There are patients who will take oral. There are patients who will take an injectable, and we'll see how many patients we can assist with both products. As regards Repatha, there's very little usage at the moment on the monthly dose. We have not had a patient-friendly dose up until now. There appear to be a fair amount of patients who would prefer to have a convenient once-a-month dose. And we're spending quite a bit of time talking to cardiologists about this, and we'll be coming to market in the next couple of weeks.

Your next question comes from the line of Robyn Karnauskas with Citigroup.

Hi, guys, thanks for taking my questions. So I have a question for David. On M&A, a lot of questions we're getting across the board in biotech on M&A. How are you thinking about how competitive this space is right now for M&A given that many players are thinking about – talking about actually buying things? Do you find the space competitive? And how do you think about timelines? Are people being more realistic about valuations? Thanks. David W. Meline - Chief Financial Officer & Executive Vice President: Sure, so I think what I would say about M&A right now is indeed, first of all, we've been consistent in indicating that we have a broad set of interests, in particular around the six therapeutic areas where we're particularly focused. And so we've said that we're open to look at transactions that could range from early to late-stage. And I think the point is we want to make sure we see everything that might be of interest to us, and I think we're seeing that, first of all. Certainly, we're in a financial position to be able to be competitive. And then secondly, it's true. We're not the only people out there who are in the market looking for opportunities. So I think the point for us is we need to make sure that we first of all look at things as to the scientific insight that we can bring to bear, including with our insight from a human genetic perspective. And then secondly, we are very clear that we're going to be disciplined in terms of the financial returns that we can expect. And we're interested in doing deals that will create returns for Amgen, not just the seller. So we continue to be active and we've got a number of pretty interesting prospects that we think could come to closure, including still this year.

Your next question come from the line of Geoffrey Porges with Leerink Partners.

Thanks very much for taking the question, just a two-part question on biosimilars and then government effects. So could you talk a little bit about how the proposed Part B changes might play out and potentially affect your business? And secondly, how might that alter the landscape for some of the biosimilars that you're developing or influence that? Thanks.

So let me take that one, if I can. This is Tony. Clearly, Amgen has raised some strong objections and questions to the proposed pilot together with about at least 300 other organizations. The concern is always when you do something based on acquisition cost around an ASP adjustment, are you ensuring that patient safety and patient concerns are included? So it's difficult to make a comment at the moment, Geoff, about something that's not been put into place yet. It's a proposal. It's up there for comment, and we're working with other people to make sure that if there is a change, patients are protected all the way through.

Your next question comes from the line of Mark Schoenebaum with Evercore ISI.

Hey, Arvind. Do you actually like Ronny Gal? Because I've known him for years and we should chat. Hey, I had a question for – I love Ronny, by the way. It's a total joke. This was touched on here and there, but your margin guidance, David, goes through 2018. We're now dangerously close to 2017. I understand you can't give us any guidance. But can you just talk to us about your latest thoughts qualitatively about where margins could go after the plan that you've announced? Should we expect further modest margin expansion? Should we be modeling something right along the lines of what you're doing now? Just anything like that, I'd love to hear you riff on that. And then, Bob, what's your appetite for an at-risk Humira biosimilar launch? And, Sean, I'd just be curious real fast to get your opinion. You guys have a CETP. I'd love to know what your opinion on that class is now, just like 30 seconds. Thank you. David W. Meline - Chief Financial Officer & Executive Vice President: So on the first one on the margin, the margin walk for the company, I would say, as we've been seeing, we're very pleased with the progress that we've made towards the goals we've set out for ourselves in 2018. So you look at the combination of continued growth of the business, you look at the progress we're making, which by the end of this year we expect to be delivering a $1.1 billion improvement on our cost base versus 2013, and we see us certainly achieving the $1.5 billion goal that we set out. Likewise, if you look at the progress on the margins where we started at a 38% margin in 2013, you've now seen us this quarter again deliver…

Just to make sure that we don't exceed the one hour of our allocated time here, may I request that you limit yourself to just one question so we can get through everybody's questions? DeMarcus, let's go ahead with next one please.

Yes, your next question is from the line of Ian Somaiya with BMO Capital.

Thanks for sneaking me in there, just a question for Tony. How should we think about the launch of yet another oral in the RA market? Are there any parallels to your experiences with an oral in psoriasis and the impact it's had on Enbrel sales there?

So the first launch of an oral was obviously not that successful. The launch into psoriasis was interesting because it expanded the marketplace and brought into the market a number of patients who perhaps were earlier in their disease, who weren't quite ready yet to move on to any injectable biologic. It's quite possible that there are a bunch of patients between methotrexate and a biologic that could become eligible for this opportunity. But if you look even in psoriasis, the overall market for the TNFs have remained, just the overall market has grown.

Your next question comes from the line of Ying Huang with Bank of America Merrill Lynch.

Ying, are you there? Maybe you have us on mute. Okay, let's go on to the next question.

The next question comes from Josh Schimmer with Piper Jaffray. Joshua E. Schimmer - Piper Jaffray & Co. (Broker): Great, thanks very much for taking the question. I was wondering if there is any difference in the dynamics for share loss to a NEUPOGEN biosimilar in the 340B hospital setting versus – the 340B (55:20) setting. Or if you can, discuss a little bit how the dynamics there might differ between those two. Thanks. Robert A. Bradway - Chairman, President & Chief Executive Officer: Again, sorry, Josh, it was...

I think you were talking about the difference between PHS [Public Health Service] and non-PHS, right? Joshua E. Schimmer - Piper Jaffray & Co. (Broker): Correct.

Clearly I think anyone who's come new into the market has gone off to non-PHS hospitals first. Joshua E. Schimmer - Piper Jaffray & Co. (Broker): What share is PHS?

I couldn't give you that offhand. It's tough to pull that type of data just offhand here. If we need to, we'll come back to you on that one.

Your next question comes from the line of Ying Huang with Bank of America Merrill Lynch.

Looks like Ying is still absent. Okay, let's go on to the next one.

Your next question is from the line of Brian Skorney with Robert W. Baird. Neena Bitritto-Garg - Robert W. Baird & Co., Inc. (Broker): Hi, this is Neena on for Brian. So I had a question about omecamtiv. I know you said that the Phase 3 protocol has been submitted, but we were just wondering what the gating factors are to starting a Phase 3 trial, just because we know the Phase 2 data has been out for a while now. So are there regulatory issues or something like that that's holding it up, or something else? Sean E. Harper - Executive Vice President-Research & Development: What I would say is that we have been moving aggressively with this program. We had to of course go through some meaningful discussions with regulators around things like the dosing algorithms that would be used, safety of the product, and so on because of the fact that just based on the mechanism and there is a narrow therapeutic window for the product, and when we're assessing drug levels and how the titration scheme. So that's moved along. I think we've been able to design a very robust study and have decided that we should put it through the Special Protocol Assessment at FDA. So things are actually moving along as fast as I would have expected to on a complex program like this.

As it's getting close to 6 PM on the East Coast markets, let's take two more questions.

Okay, your next question comes from the line of Ronny Gal with Bernstein. Aaron Gal - Sanford C. Bernstein & Co. LLC: Good afternoon and thank you for taking my questions. My question is about indication-based pricing in anti-TNF and the broader anti-inflammatory market. How do you guys think about this? Is this good, is this bad? Will it impact Enbrel in a positive way, maybe willing participants or less so, to see if you could give some color.

It's Tony. Let me respond to that one as best I can. First of all, Amgen has been really at the forefront of innovative solutions to improve patient access, including innovative contracting such as outcomes-based and risk-based contracting. We are partnering with payers on patient-centered approaches to ensure that patients get access to the best available medications, and that physicians make the right choice for the right patient, and at the same time the patient share of cost is manageable. As regards indication-specific contracts, I think it's too early at this stage to actually give any comment about what the impact could be.

Your final question comes from the line of Cory Kasimov with JPMorgan.

Hey, good afternoon, guys. Thanks for squeezing me in. I wanted to ask about pricing as well. I'm really curious on how we should be thinking about the sustainability of price increases in this environment. More specifically, when thinking about Enbrel and the four meaningful increases you've had in the last couple years, I assume you're not getting much pushback at the payer level to be able to push these through. But are you comfortable with us modeling this pace of increases to continue, as I think many were assuming this would tail off across the space given the rhetoric that's out there? Thanks.

So, Cory, again, a question that a lot of people are asking I'm sure. But as you know, we price our products based on the value in the marketplace, taking into account the value they bring to payers, to providers, to patients, the competitive landscape itself. Enbrel in particular of course competes in a highly competitive marketplace with several large players who are competing for formulary placements to enable patient access. The health plans and the PBMs negotiate price concessions and large rebates to gain formulary placement. Because of the magnitude of these rebates, price increases have become part of the competitive dynamic. That's about all I can tell you at the moment.

Great. Thanks, Tony. I'd like to also thank everybody for your participation in our call. As you go through our results, if you have added questions, observations, feel free to reach out to me. Myself and my team will be around for several hours. Thanks again.

Ladies and gentlemen, this concludes Amgen's second quarter financial results conference call. You may now disconnect.