My name is Jade, and I'll be your conference facilitator today for Amgen's first quarter 2016 financial results conference call. All lines have been placed on mute to prevent any background noise. There will be a question-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 that you limit 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, Jade. Good afternoon, everybody. I'd like to actually begin by extending my gratitude to all of you for having to deal with the deluge of earnings reports from multiple companies reporting today. I appreciate you being on our conference call to review our operating performance for the first quarter of 2016. We are off to a great start for the year. And to review our progress, Bob Bradway, our Chairman and CEO, 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. Tony Hooper, our Head of Global Commercial Operations, is here to discuss our product performance during the quarter; followed by our head of R&D, Sean Harper, who will provide a pipeline update. We will use slides for our presentation today. These slides have been posted on our website and a link was sent to you separately by e-mail. Our comments today will be governed by our Safe Harbor statement which in summary says that through the course of our presentation and discussion today we may make certain forward-looking statements and actual results may vary materially. So with that, I would like to turn the call over to Bob. Bob? Robert A. Bradway - Chairman, President & Chief Executive Officer: Okay. Thank you, Arvind, and let me also thank our listeners for joining the call. As Arvind said, we're off to a strong start in 2016 with 10% revenue growth and 17% adjusted earnings per share growth in the first quarter. Our sales were strong in the U.S. and internationally, and that was true broadly across our products. As you can see from these results, we've put the company in a strong position to manage competition for our legacy products while…

Thank you, David, and good afternoon, folks. You'll find a summary of our sales performance for the first quarter on slide number 10. As Bob said, we had a great start, with global product sales in the first quarter growing by 7% year over year. Our U.S. business delivered 9% year-over-year growth, and sales growth in our international business was negatively impacted by five percentage points due to foreign exchange. Excluding the foreign exchange impact, our international business was up 7% year over year. I will structure my comments in three categories today: performance in our growth products; how we are managing the life cycle of our mature brands; and conclude with an update on the performance of our newly launched products. First, our six growth products – Prolia, XGEVA, Vectibix, Nplate, Sensipar, and Enbrel – aggregated nearly $3 billion in sales or over 50% of the first quarter sales, growing 20% year over year. Sustaining their growth continues to be a priority for us. Let me start with Prolia and XGEVA, which are now annualizing at approximately $3 billion per year. Prolia grew significantly at 29% year over year. Continued share gains drove growth in both the U.S. and Europe, although with 25% year-over-year unit demand growth in both regions. We saw the typical seasonality in the first quarter. In the U.S., our direct-to-consumer promotional efforts continued to drive increasing levels of new patient adoption, and we are sustaining repeat injection rates of over 65%. We expect continued growth from Prolia to come for years. XGEVA grew 11% year over year. Unit share increased about three percentage points over last year in both the U.S. and Europe. The first quarter was positively impacted by increased levels of purchasing by some large end customers in the U.S., which we expect…

Yes, Jade, if you can, go ahead and open it up for Q&A and just review the procedure for asking questions, please.

And your first question comes from the line of Matthew Harrison from Morgan Stanley. Matthew K. Harrison - Morgan Stanley & Co. LLC: Great, thanks for taking my question, just a couple clarifications for Tony. You mentioned two end customer purchases for Neulasta and XGEVA. Can you tell how large they were? And then second, maybe if you could, just expand around your comments for REPATHA. I think it's our understanding that 70% to 80% of scripts are abandoned at the pharmacy. What's your view on what needs to change to lower that rate? And how should we think about the change that outcomes data, if positive, could have there? And is there a rate, a hazard ratio, for example, in the outcomes data, that you think would cause a significant shift in some of those utilization management criteria? Thanks.

Okay, so let me try and go through those. So on the large customer end user purchases for XGEVA and Neulasta, so in the range of $30 million to $50 million, so not a large amount, but they will clearly burn off during the second quarter. When I look at REPATHA, it is about a 77% rejection rate, not abandonment, that's happening at the pharmacy. So a lot of the prescriptions being denied because they don't quite fit the prior auth process which has been required. Talking to cardiologists, it's clear that they are extremely frustrated at the moment because the patients they're sending in are appropriate patients who are not being properly managed on their maximum tolerated statin at the moment. We are spending quite a bit of time with payers at the moment, and helping them see the – what I would imagine that the unintended consequences of a rather onerous paper-based prior auth system, which is resulting in so many patients not getting access to drug when they should. So, I think with a bit more discussion, people will understand the importance of getting appropriate patients on drug. I think of some of the question in terms of narrowing the population is around what will the outcomes show. And there's no doubt in my mind that once we have limited proof that this drug actually results not only in lowering LDL, but in actually reducing the risk of heart attack and stroke, that more patients will gain access to the drug.

Jade, let's go with the next question, please.

And your next question comes from the line of Geoff Meacham of Barclays.

Good afternoon, guys. Thanks for taking the question. I just wanted to talk a little bit about romo, just looking at the non-vertebral fracture data, do you think that this could be a big variance competitively? And then, what's the outlook for the European filing based on the PMO data? Do you think that the – there's a risk that secondary end points that may have to be hit on that? Thank you. Robert A. Bradway - Chairman, President & Chief Executive Officer: Thanks, Jeff. Sean, why don't you take those questions? Sean E. Harper - Executive Vice President-Research & Development: In terms of the results, the second part of the question relates, I think, to the ability to file the data set in Europe, and we do believe the data will support registration as is in Europe, but we also have always planned to file both outcomes – fracture studies. So we have the alendronate controlled study in which the primary end point is clinical fracture that will be part of that – part of that file. I think that when you step back there are a couple things. One is that we need to present these data at the appropriate scientific congresses and publish them so that the experts in the field can look at the data, because the paradigm for the study design is so different than what people are used to with a three-year placebo-controlled portion rather than a one-year placebo-controlled portion. And in the end, the most important endpoint to look at with these therapeutics we've hit which, again, is the symptomatic vertebral fractures plus non-vertebral. And we had quite a significant effect size there as well as the transition from treatment with romosozumab on to Prolia where we continue to see benefit of romosozumab into the second year on Prolia. So overall, I think the data will be well-received when people are able to look at it in some detail.

And your next question comes from the line of Terence Flynn from Goldman Sachs. Terence Flynn - Goldman Sachs & Co.: Hi. Thanks for taking the question. Maybe first, just was wondering if you guys could comment on the Treasury notice and intercompany debt and any potential impact to your longer term tax rate. And then any potential for an FDA panel on etelcalcetide? Thank you. Robert A. Bradway - Chairman, President & Chief Executive Officer: Sure. Okay, David, why don't you take the first? David W. Meline - Chief Financial Officer & Executive Vice President: Yeah, so on the first one, so first of all Amgen, of course, is not a company that's inverted, so we're a U.S.-based company. And all of our debt is issued and received from third parties, so we don't see any impact on our business in terms of our ability to finance and the ability to deduct the interest expense from our earnings. So, right now we don't see any impact. But it's a pretty detailed and lengthy ruling so we continue to look at it, but we don't foresee any right now. Sean E. Harper - Executive Vice President-Research & Development: And, Terence, it's Sean. We don't anticipate the need for an FDA advisory committee for Parsabiv.

Okay. Jade, let's take the next question.

Your next question comes from the line of Alethia Young from Credit Suisse. Alethia Young - Credit Suisse Securities (USA) LLC (Broker): Hey, guys. Thanks for taking my questions. I just wanted to ask a little bit about Kyprolis and if you were seeing any competition with DARZALEX or any of the other of the new regimens on the market. If you could give me color there, that would be great.

Okay. So let me answer that question. This is Tony. Clearly, as I said, the addition of the ENDEAVOR data to our label, giving us both a doublet and a triplet regimen in second line, both with clinical data showing great efficacy versus the prior regimens, has put us in a good position to give patients in second line plus a better opportunity. The data in the market is quite shallow because we haven't looked at the patient chart orders. But as I look at the orders for the first quarter, I see Kyprolis continue to hold market share in third line. I see continued growth in the second line. And I see the newer entrants with very slow single digit market shares and predominantly being used in fourth line plus.

And your next question comes from the line of Cory Kasimov from JPMorgan.

Hey. Good afternoon, guys. Thanks for taking the question. So with regard to REPATHA access, assuming you get positive CVOT data later this year, what's your understanding of the process you'll need to follow in order to ease kind of current utilization management? I guess I'm wondering how fast things could open up, or if you're going to need to get the data and the label and renegotiate with payers first before you're able to tag a noticeable difference on that front? Thanks.

So, as Sean said, we're expecting the data in the latter end of this year. Once the data becomes clear it'll become public. And I think people will have to make up their minds what that actually means. It will be presented then in a peer-reviewed publication and presented at one of the large congresses where the data will become clear to all the prescribing cardiologists. We, of course, from a commercial perspective are not in a position to negotiate or talk to payers about the data until the FDA has approved it in our label. In the interim, however, our medical affairs organization can respond to questions that we receive from the payers in a balanced and medical way. But I'm assuming once this becomes clear, the details will just clarify the unique value of this particular product. Sean? Sean E. Harper - Executive Vice President-Research & Development: This is Sean. I think the other comment I would make is that you may have seen that the – that some of the U.S.-based guidelines for treatment of hyperlipidemia and cardiovascular risks were recently updated and included the concept of using the PCSK9 inhibitors after stepping through some other therapeutic options that have the cardiovascular outcomes data. It's my understanding from talking with many of the key opinion leaders who are either involved in the guidelines or just thought leaders in the field, there's – there's a clear desire to update these guidelines as fast as possible when the cardiovascular outcomes data are available. So that's an independent process from anything to do with getting good data into the label and can be a very important thing that payers look at when they make access decision.

Jade, let's take the next question.

And your next question comes from the line of Mark Schoenebaum from Evercore ISI.

Hey, guys. Maybe a question for Bob. In this environment, biotech prices have obviously come down. So I'm wondering what your current feelings, Bob, are around hostile acquisitions? Thank you very much. Robert A. Bradway - Chairman, President & Chief Executive Officer: Mark, I don't know that I'd make any comments about hostile acquisitions but, as you've heard us say before, evaluations in some areas are more attractive this year than they were last and we have a strong balance sheet and we continue to look carefully both internally and externally for the most attractive programs that we can advance. But we look at all range of transactions, licensing, as well as M&A, and we consider them each individually. So I wouldn't speculate, Mark, about anything more than that at this point.

And your next question comes from the line of Michael Yee from RBC Capital Markets.

Great, thanks, a question for Sean. The pivotal CGRP data is certainly coming and there's a wealth of data coming. You've talked in the past about your hypothesis, about your mechanism and some differentiation. Can you maybe update us on your thoughts about how you still see that playing out as some more data has come out and just where data has played out? Can you maybe list one or two things where you specifically see some differentiation or how that plays in the future? Thanks, Sean. Robert A. Bradway - Chairman, President & Chief Executive Officer: Thank you, Michael. Sean E. Harper - Executive Vice President-Research & Development: So, Michael, I don't think much has really changed in terms of the fact that there's sort of fundamental scientific principles here around the difference between a receptor antagonist and the ligand. We've always felt that the receptor antagonist would be more potent, and we're seeing that play out. We've always thought that might result in a situation in which the administration profile of the product was better than it would be if larger amounts of protein were necessary for delivery, for example, on a monthly basis in a subcutaneous delivery device. So, I continue to think that it's a relative advantage to have a more potent agent when you're trying to administer infrequent dosing subcutaneously. But whether that will be really play into being an important clinical differentiator when these products are out in the marketplace is, I think, too soon to know. Otherwise, we continue to push very hard on the product to get it to patients as fast as we can because there are about 26 million people with migraine in the United States, and among them there's somewhere in the order of 8 million to 10 million who have had attempts or are currently on and off of therapy for prophylaxis. So there's clearly a very large unmet medical need, and some proportion of that population would be an appropriate population, potentially, for this sort of therapeutic.

And your next question comes from the line of Josh Schimmer from Piper Jaffray. Joshua E. Schimmer - Piper Jaffray & Co. (Broker): Okay. Thanks for taking the questions, and maybe one for Sean. Amgen has had such a strong track record advancing the Phase 3 programs through to commercialization. Curious as to what there is in the Phase 2 or earlier pipeline that you're most enthusiastic to move into Phase 3; you mentioned omecamtiv, curious as to what else. Sean E. Harper - Executive Vice President-Research & Development: Sure, I like to talk about that sort of thing. The certainly omecamtiv is very exciting. We also, as I mentioned, have another migraine prophylaxis antibody and of course, the potential to actually develop a bi-specific antibody that would address both of those pathways as a product behind that. Heart failure does remain a real focus for us, and we actually are introducing a novel, completely novel heart failure medicine into the clinic in a matter of days from now, which is exciting and have quite a few early discovery-level programs in that area. Cardiovascular more broadly, we have some very interesting things we're working on in the early and midstage pipeline. And of course, the BiTE platform has a very large number of products in pre-clinical phases that are moving toward the clinic. And we're seeing a situation in which we're going to be introducing into the clinic multiple different therapies in some cases, with different targets directed at the same hematological malignancy, for example, and are having to envision some interesting multi-armed clinical trials to try to get some efficiency in the testing when we have so many things coming forward simultaneously. So there's a lot going on. Because of everything that happens, that's happening at the commercialization interface, we don't get a lot of time to talk about that, and perhaps we'll have an opportunity in an upcoming business review setting to go through some of this in some more detail.

And your next question comes from the line of Robyn Karnauskas from Citi.

Hi. Thanks for taking my question. So just thinking a little bit big picture on the REPATHA launch, I think you called it like a slow launch. And you were talking about working with payers. How much are you willing to participate and deal with price versus, say, mortality outcomes? So what's the balance of lowering price and mortality outcomes as far as opening up access? Thanks.

Robyn, it's Tony. Clearly as we've said, we bring our products to market with a clear debate and discussion around the pharmoeconomic value of the products. There was an extrapolated value that these drugs would actually result in reduction of both stroke, heart attack, and early untimely death, and I think we will continue to bring the value to market. There are rebates in the marketplace at the moment, and that dynamic will continue over time as we jostle for formulary positions. But I think what we bring to market at the moment is a pretty decent and acceptable value proposition to treat patients at high risk.

And your next question comes from the line of Eun Yang from Jefferies.

Thank you for taking the question, a question on Parsabiv. With the bundled payment in dialysis, what do you think could the pricing power be for the product like this, particularly since Parsabiv is expected to go generic in a couple of years? Thanks.

All right, so it's Tony. Let me answer that one. So as you know, CMS have gone with a two-year period, that this product will operate outside of the bundle under the ASP pricing method, which will give CMS two years to evaluate the product value and then to make a decision how much value is put into the bundle when the product moves from ASP into the bundle.

And your next question comes from the line of Ying Huang from B-of-A Merrill Lynch.

Hi, thanks for taking my question. The first one for maybe Sean to talk about a few outcome trials here. I know you guys never disclose the powering assumption or the assumption for event rate. But should we assume that it's probably similar to what your competitor has talked about? And then secondly, I have a question on the EPO market. So Fresenius is switching to Mircera from Roche. You have a long-term contract with DaVita. What is your thought of the other one-third of the market with EPO and also (52:15) going forward? Robert A. Bradway - Chairman, President & Chief Executive Officer: We'll take this in two parts. Sean will take your first question and then Tony can address your EPO question. Sean E. Harper - Executive Vice President-Research & Development: Actually both we and Regeneron and Sanofi have published papers on the design of these studies, where there's a quite a bit of detail in the way that they were constructed. And in the end, these types of studies differ largely on the issue of how long it takes to enroll the population and what the event rate is once you get patients enrolled. There are not, we don't believe – we would not anticipate large differences in the event rates between the two populations, but there will be some difference in event rate. And I think both companies have set their studies up so that they would be able to detect what was considered to be a clinically meaningful minimum effect size, so typically one would set these kind of trials up so that you wouldn't miss a 20% reduction in risk. Obviously, you may be looking for more, but that would be the way you power the trial. So there are more similarities than there are differences.

Okay, so let me answer your question on the dialysis market. You're right, the market is broken into three. DaVita is responsible for about one-third of the market. We have a contract with them that is exclusive that runs to 2018. Fresenius, who is responsible for another one-third of the market are in the process of converting a lot of their patients. The last time they made any numbers public, they were talking about just over 70% conversion to Mircera. The other one-third of the market is the independent medium and small dialysis units. In that setting, we have converted about 70% of the EPOGEN usage to Aranesp.

And your next question comes from the line of Geoff Porges from Leerink Partners.

Thank you, I appreciate the question. Tony, a couple for you. Could you talk a little bit about price on Enbrel, the contribution of price? Should we just infer that it's the difference between the growth, the units, and the inventory? It looks about 20%. And could you just talk about whether that looks to be sustainable given the market environment? And then on a related note, could you talk about the value proposition for AMG 334? Certainly, millions of patients out there with migraine, but you can imagine payers preparing to do some of the things that they did for REPATHA. So how do you think that you're going to approach the value proposition of that indication to avoid the sort of really tight restrictions that you've encountered?

Okay. So let's go back to the front end. Just to reconfirm again, what we report and what we talk about in terms of net price, and really that's a combination of the list price minus the rebates and/or formulary positions you have in the marketplace. I think as a company we're acutely aware of the issues facing the industry in the U.S. at the moment. But Amgen's all about innovation, right? So we price our drugs around the pharmacoeconomic value of the products as we bring them to market. Enbrel itself, of course, is competing in a highly competitive marketplace where several large players are competing for formulary position to enable patient access. At the same time, the health plans and the PBNs are negotiating price concessions on large rebates to set up formulary placements themselves and it's because of the magnitude of these rebates that price increases have become part of this overall dynamic. So, it's an integrative process flow as we go forward. Talking about 334, as Sean has said again and again, this is a huge unmet medical need in the marketplace where existing therapies have side effects that are sometimes as bad as the disease itself. Unlike most other diseases, patients with chronic migraine really know about it. It's debilitating. It's devastating. And some of the initial research we've done have shown a much higher inclination or preparedness to pay a co-pay because patients really want to get rid of the disease as quick as they can. I think most of the patients who are available to us have been on therapy for some time and were able to show they've been on therapy. So step edits I'm sure will be there. But there's a large bolus of patients who have failed consistently on existing treatment in the marketplace.

So, Jade, I'm noticing that it's fast approaching 6:30 on the East Coast. Why don't we take two last questions?

And your next question comes from the line of Jim Birchenough from Wells Fargo Securities.

Hi, thanks for squeezing us in. This is actually Yanan Zhu in for Jim. I wanted to ask a question on the CGRP program, specifically on the regulatory path. As you know, it's a competitive space with four players. You have the clear lead, the first Phase 3 data readout for that frequent episodic migraine indication. However, in a chronic migraine indication, it's a little less clear, because others have Phase 3 programs ongoing. Interestingly, you just mentioned, you commented that you might use the Phase 2 data that is going to read out – the Phase 2b data in chronic migraine – to support a BLA. Our question is, do you think you will seek a chronic migraine indication based on the Phase 2b data? Have there been any discussion with regulators on that? Thanks. Sean E. Harper - Executive Vice President-Research & Development: This is Sean. I think that the things have you to take into account is that the chronic migraine Phase 2b study is quite a large study and it explores doses that are used in the two large Phase 3 episodic migraine studies. And these are obviously – there's a spectrum of disease here – and while there is a separate regulatory entity of chronic migraine and episodic migraine, the path of physiology is probably quite shared across these as evidenced by the fact that all the CGRP antagonists are having similar efficacy in the different patient populations. So it's our feeling that taken together, the aggregate data could potentially support both indications being granted at least by some of the global regulators. And I would not typically go into the discussions about the specific conversations we've had with regulators, but I'd just say that we feel that it's a very reasonable approach to attempt to get both indications based on the aggregate data package.

Great, let's take one last question.

And your final question comes from the line of Jeff Chen from Cowen & Company. Jeff Chen - Cowen & Co. LLC: Hi. Thanks for taking my question. For Tony, could you just discuss a little bit more about REPATHA in EU and Japan in terms of your experience of access and reimbursement? And if you think that the CVOT outcomes data will change the negotiation, or would that be a new round of negotiations? Thanks.

So I think if you've heard people talk about the (1:00:36) performance in Europe where once the price has been set and reimbursement is agreed, there's no longer an economic decision around every prescription, so uptake happens quite fast. So I believe that as we get into growing into this marketplace, pricing is just about set. When you come in with larger expanded patient population groups, there's a chance in Europe, you have to go back in it in a country-by-country negotiation. In Japan, historically, that hasn't happened as much, and the pricing we receive in Japan seems to be a longer play-through from pricing.

Great. Thank you, everybody, for your participation on this busy, busy day. Of course, I'll be around together with the rest of my team, so if we can offer any further assistance, please give me a call. Have a good day.

Ladies and gentlemen, this concludes Amgen's First Quarter Financial Results Conference Call. You may now disconnect.