My name is Jake Long, and I'll be your conference facilitator today for Amgen's fourth quarter 2015 earnings conference call. I would now like to introduce Arvind Sood, Vice President of Investor Relations. Mr. Sood, you may now begin.

Okay, thank you, Jake. Good afternoon, everybody. I would like to welcome you to our conference call to review our operating performance for the fourth quarter and full year 2015. I would particularly like to acknowledge those who are new in their coverage of Amgen, including Steve Chesney of Atlantic Equities in London, Ronny Gal of Bernstein, Alethia Young of Credit Suisse, Hartaj Singh of BTIG, and Brian Skorney of Baird. Welcome. Each of us look forward to working with you and helping you understand of our company. We have a lot of ground to cover today, so let me make some very quick introductions. Leading the call today will be our Chairman and CEO, Bob Bradway, who will provide a strategic report on our performance in 2015 and outlook for 2016. Following Bob, our CFO, David Meline, will review our Q4 and full-year results and update you on our previous preliminary financial guidance for 2016. Tony Hooper, our head of Global Commercial Operations, will then discuss our product performance during the quarter, with a particular focus on newly launched products. Following Tony, our head of R&D, Sean Harper, 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 email. 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. Robert A. Bradway - Chairman, President & Chief Executive Officer: Okay, thank you, Arvind, and let me add my welcome to those of you who are joining our call. Let…

Thanks, David, and good afternoon, folks. You'll find a summary of our global sales performance for the fourth quarter on slide number 10. Globally, product sales grew 3% year over year for the fourth quarter and 8% for the full year. Our U.S. business delivered 5% year-over-year growth in the quarter and 12% for the full year. The fourth quarter included the negative $100 million impact related to the large quarter three end customer purchases that I described in our last earnings call. Foreign exchange negatively impacted year-over-year sales by two percentage points in both the fourth quarter and the full year. Excluding the negative impact of foreign exchange, our international business was up 5% year over year for the fourth quarter and up 6% for the full year. By any measure 2015 was a success from an operating and execution standpoint. Our growth products led the way, as they continued with meaningful growth. We also laid the foundation for future success with our new product launches, as well as further expansion into new countries, while transforming our customer-facing model and delivering significant cost savings, which we reinvested in the launches. Let me now start with an update on our new cardiovascular franchise, where we had two launches in 2015, Repatha of course being the biggest opportunity. Repatha is off to a strong competitive start. In the U.S. Repatha's relative share of the segment is reflective in my mind of our launch preparations and execution in the field. Brand recognition amongst cardiologists and primary care physicians is strong. And Repatha's single dose delivering intensive and predictable LDLC level reductions is resonating well with prescribers. We've made good progress with our payer negotiations. More than 80% of commercial lives currently have access to Repatha. But strict payer utilization management criteria are…

And your first question comes from Matthew Harrison of Morgan Stanley. Matthew K. Harrison - Morgan Stanley & Co. LLC: Great, good afternoon. Thanks for taking the question, maybe if I could just start with one for Sean. On romo [romosozumab], people are obviously focused on this data and focused on the potential safety of that molecule. Could you just address for us how you think about the potential for some imbalances and falls or hearing loss or some of the brain volume growth that obviously make people worried about neurological symptoms? And then in addition to that, just talk about, to the extent you can, what the DSMB has looked for, what sort of monitoring you have, and the study around those issues. Thanks. Sean E. Harper - Executive Vice President-Research & Development: Yes, so I think obviously when one looks, this is a genetically validated target, and when one looks at the rare familial forms of absence of sclerostin or partial absence of sclerostin activity such as van Buchem's disease or sclerosteosis, these individuals from conception are deficient in sclerostin. And so as a consequence of course, over time, often in their third or fourth decade, they begin to have some untoward effects from this, such as very thick skull plates and the foramina in which cranial nerves that exit from the skull can impinge on the nerves due to overgrowth of bone. I think that this is something that is an effect developing from conception with the absence of sclerostin. And I just would contrast it sharply with giving one year of therapy to generally quite elderly, at least middle-aged at minimum, osteoporotic patients. So I think of course in an abundance of caution, we are doing testing on hearing and some other things that are designed to assess these kind of theoretical risks. But I would certainly be very surprised to see a pharmacodynamic response from the drug that would result in those kind of complications. The DSMB, of course, is fully aware, as all our investigators are out doing the trials, and patients through informed consent that all of the theoretical and established potential risks of these kinds of investigative products.

And your next question comes from the line of Eric Schmidt from Cowen & Company. Eric Schmidt - Cowen & Co. LLC: Maybe for Tony on Repatha's uptake, you noted the happiness on your part with the share gains. But are you disappointed overall with the size of the pie at this stage? I know you're seeing reimbursement headwinds. But nonetheless, I guess is this on a more shallow trajectory than you thought? And assuming we do get the positive outcomes data toward the second half of the year, should we see an immediate benefit from that, or would you think it would still take some time to work with payers to work through these headwinds?

Thanks, Eric. So I'm glad you see the relative performance in the marketplace. The hub we put together was clearly done because we understood there was going to be a little bit of time before the payers made a decision around formulary approval. And to me, the hub has therefore been a surrogate to the level of prescriptions that cardiologists and endos and primary care physicians are prepared to prescribe. We are seeing a really robust level of prescriptions coming through the hub. So to me, that continues to give me great confidence in terms of physician willingness to prescribe this drug for patients who fit inside the label. The prescriptions themselves in terms of both the NBRxs and the TRxs are continuing. It's clear that the utilization management criteria in place is restricting the number of prescriptions that get dispensed. And we are working with payers at the moment to make sure that patients who are eligible actually get access to these drugs.

Then on the outcomes study.

So the outcomes study, clearly I think one thing that's clear what the value of this drug is, physicians, patients, and payers will realize a tremendous amount of value. Now I think there will be a time between the data becoming present and the data moving into the label that we'll be negotiating with payer by payer. But once it's in the label, it's clear that we should see some dramatic uptake then, yes.

Jake, let's take the next question please.

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

Afternoon, guys. Thanks for taking the question, a couple on Repatha as well. So, Tony, when you look at the subtleties, either reimbursement or populations or clinical practice, can you compare the EU and Japanese markets to the U.S., assuming that you do get an outcomes data this year? And then just to follow up to Eric's question on the U.S. market, what can you tell us in terms of leading indicators of demand? In other words, like physician prescribers or visits to your hub or things like that? Just want to get some demand metrics beyond TRx. Thanks.

I think I understand your question about access outside the U.S. So one has to remember that outside the United States, once access is granted, physicians are not making a decision on anything other than a clinical decision around the value for patients. So there is no economic decision once you have access in Europe and in Japan. So the negotiation is to get access as quickly as possible, and then to move patients onto the drug as physicians prescribe. From an inside the U.S. perspective, yeah, it's the number of prescriptions we're seeing across the range of physicians who have been prescribing it is encouraging. And I'm not quite sure what more you want to hear about it, Geoff, sorry. Did I answer your question? Or did I miss a question there?

And your next question comes from Alethia Young from Credit Suisse.

Yeah, hang on, Jake. Before you move on to Alethia, Tony was asking if he had addressed Geoff's question.

Geoff, was that okay? Was there anything else?

Okay, looks like we might have lost him, so let's go on with the next question from Alethia. Alethia, go ahead. Robert A. Bradway - Chairman, President & Chief Executive Officer: Alethia, we can hear you. Go ahead. Alethia Young - Credit Suisse Securities (USA) LLC (Broker): On NEUPOGEN, I know you said you were going to compete account by account. And so far you have share – you still have 76% share. But can you give us a little flavor on the progress that you've done there? Have you spoken to the majority of accounts? Just help us think about how much defense you're playing and how much success you're having. And then on Neulasta, I guess I wanted to think about – with the Onpro device, do you think that business is now sticky? And we should think about that as share that's now protected if there were a biosimilar to emerge in 2017?

Okay. So NEUPOGEN, tough to answer your question. We clearly segment the NEUPOGEN account between large, medium, and small. And we decide which ones we're going to defend and which ones we're going to be letting go. As you know we've had competition on the market for over a year now plus a biosimilar competitor for close to six months. And we still hold 76% of the market share. As regard to the on-body injector for Neulasta, the main reason we brought it to market is the unique distinctive value this drug – or that this device brings to patients and to the physicians and clinics and institutions. Most patients try and get their chemo on a Friday; then they can spend the weekend recovering before they go back to work. Neulasta requires them to come back on a Saturday morning to get their last injection. So sometimes what was happening is patients were getting the injections too early, which is actually not good. It actually reduces the effectiveness of the drug quite dramatically. Or two, they were not coming back for the injection at all, so exposing themselves to potential febrile neutropenia. So the real value that we've picked up from patients, from nurses, from physicians, and from institutions has been we are increasing the opportunity to give patients the right number of cycles at the right time and really reduce the possibility of febrile neutropenia dramatically. This is the benefit we sell the device on consistently, which I'm sure will continue and stick. Alethia Young - Credit Suisse Securities (USA) LLC (Broker): Great, thanks.

And your next question comes from the line of Terence Flynn from Goldman Sachs. Terence C. Flynn - Goldman Sachs & Co.: I was wondering, you talked about the label expansions and some of the benefit there. But I was just wondering if you could comment on the potential future contribution from once-weekly dosing? Is that really one of the key drivers of an inflection here? And then any commentary you can provide on average treatment duration trends for Kyprolis? Thanks.

So I think with Kyprolis, we have to start with our true belief that driving deep remission is where clinical practice is going to go. And the combinations using Kyprolis as one of the products in the backbone is clearly showing us these huge extended periods of PFS, which by definition is helping us drive deep remission. Patient convenience down the line will become important. And I think the once a week dose will certainly help with patient convenience to ensure that patients stay on the drug for as long as we can. As regards to duration, when we look at the chart orders, we see that products in this category in second line are probably being used between about seven months to eight months at the moment. It's difficult to quote Kyprolis data yet, because we only got approval for the second line in July. So we're hoping to see some extended data in the next couple of quarters.

And your next question comes from the line of Matt Roden from UBS.

Great, thanks very much for taking my question. I want to go back to romosozumab. Just wanted a little bit more from the commercial side, because if the trial works, we're all going to be interested in the opportunity for the product. So to that end, I was wondering if you could elaborate a little bit more on the strategy to at least initially administer the drug in the doc offices by a healthcare provider. Can you just talk about why you think that's beneficial for the patient? And whether or not you think that that's the best way to maximize the potential to impact patients? And then I guess a related follow-on to that would be, can you talk about what work you're doing to maybe provide a self-injection option down the line? Thanks.

So let's start with Prolia because we've spent the last four or five years now building a level of expertise on Prolia. And we were the first biologic, injectable biologic to launch into a GP-type market, a complex process which I think the team have got their hands around. And as you see the data in the U.S., Prolia continues to grow in leaps and bounds as we get both breadth and depth of prescribing happening. It's clear to us that a lot of these patients are elderly, and coming back to the doctor is important to ensure they get the injection. When I think about any other potential competition to romo, the biggest complaint they have is the difficulty of daily injections, of course. So we do see that the same targets that are prescribing Prolia would be targeted to go to, to talk about romo. And we think that the large unmet opportunity in the marketplace, this is quite a large opportunity for us to go to market with. Robert A. Bradway - Chairman, President & Chief Executive Officer: Do you want to say anything about future plans on administration?

We are always looking to advance and improve on the way we actually bring to market a combination device product, and we will continue to look at effective and efficient ways for those patients who decide that self-injection could be an option, yes.

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

Thanks. I had a question for Sean regarding romo. I think that certainly we think that should work, but I actually wanted to ask scientifically. Could you remind us how confident you are in translating that superior BMD data to superior fracture data, particularly against a high-efficacy drug like Forteo, if similar or to what magnitude it could be much better numerically? And then in year two – I know you're testing the hypothesis of that design in your study. But what would you expect in year two? And is there any reason that it would not be maintained across year two? Thanks. Sean E. Harper - Executive Vice President-Research & Development: What I would say is that the confidence level we have about the BMD, which as you know is the most impressive BMD increase that's been seen in humans with any treatment, translating that into fracture resistance, that confidence is high. I think that the genetic validation that exists for the pathway is very convincing to people in the field. Also, we saw – this is one of the few areas where the preclinical models, particularly those performed in non-human primates, are really quite predictive of what you'll see in humans. And then in a non-human primate, we were able to do biomechanical testing of bone, of course, after animals are sacrificed. And so we know that we achieved extremely high bone strength in these animals commensurate with the BMD increases. And finally, we've done very advanced imaging of humans that have been treated with romosozumab and compared it head to head to what we see with Forteo. And as you probably know, Forteo has its major impact on trabecular bone and has a relatively limited impact on cortical bone. And cortical bone really is what matters for…

Jake, before you go on to the next question, Tony had an additional comment on Geoff Meacham's question about the Repatha demand indicators. Tony?

Sure. So, Geoff, I think I better understand your question now, more around in addition to TRx's, what else should we be looking at to see future growth in the marketplace. Like always, to me TRx's and MDRx's in terms of new naive patients are the most important thing to measuring in terms of the growth. But with a new launch like this where the plans are put into place at the formularies, one has to remember that IMS only reports dispensed prescriptions; i.e., prescriptions that come to a pharmacy or a specialty pharmacy and the patient actually walks away with the drug. What you have to be able to look at inside that data is how many prescriptions get to the pharmacy and how many are rejected versus how many are abandoned. So we are seeing that the majority of prescriptions getting to the pharmacy at the moment are being rejected, rejected because the prior authorization process has not been properly completed or there's some outstanding information and patients have to go back and get some more data. All patients are seeing the copay at this particular stage because the product is not properly on formulary yet as being too high a copay, and they abandon the prescription and they walk away. So the data you're seeing is really important, but you have to understand that the majority of prescriptions getting to the pharmacy are either being rejected or abandoned at the moment while the plans complete their process, which is why we spent so much time with the plans at the moment showing them the number of eligible patients who are on label getting to pharmacy and not getting product. It really is a concern. And when you think about the potential Repatha patient, these are patients that are at risk right now for a cardiac event and therefore early intervention is essential, so we're spending quite a bit of urgent with the payers.

Great. Thanks, Tony. Jake, let's take the next question, please.

And your next question comes from the line of Joshua Schimmer from Piper Jaffray. Joshua E. Schimmer - Piper Jaffray & Co (Broker): Hi, thanks for taking the questions. I just wanted to come back to the Repatha management criteria that are limiting uptake. Can you elaborate a little bit on what the primary causes for rejection are? Give us any sense as to the evidence that you are making progress in addressing some of these issues. And then given what those issues are, what gives you the confidence that the cardiovascular trial data may ultimately resolve that as a barrier? Thanks.

So it's Tony here, Josh. Utilization management criteria obviously differ plan by plan, but they include things such as patient must restate naturally tolerated statin dose or someone requires you to be on one or two statins. Some of them require you to have done statins plus a step-through to Zetia. There's clearly a requirement around your LDLC level, they have to be at a certain level. But probably the more complex thing is the prior authorization documents. There are five pages of handwritten stuff that physicians have to find out about. And most of the rejections are because the form is not properly completed, and this is the time to collect the data. So as we get the process running a bit more efficiently and hopefully moving from paper to an electronic process, the prior authorizations could go faster. And then as we show the payers the impact of too draconian a utilization management criteria not getting to the right patients, we will see some changes there. The outcomes data of course will dramatically change the value of this particular drug, and we do expect to see some changes in the utilization criteria once we have that turn.

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

Hey, guys. Thanks for taking the question, three questions. First, I'd like to know where Arvind buys his ties. Second question is Pfizer has made the decision to enroll primary prevention patients I believe into their Phase 3 PCSK9 outcomes trial, Sean and Tony, and I was wondering. They expect to have a label indication for that, and they believe that that's very important for the payers. Why did you make the decision not to design your trial that way? Maybe that's a Sean question. And for Tony, what commercial implications, if any, is this going to have in your mind? And then third, just to follow up on someone else's question, just to be more direct, I think what's going on, on the Street right now is people are concerned that the romo fracture reduction magnitude may look optically less than what is contained, for example, in the Forteo label or some of the data that Radius has produced for the PTH analogue, primarily because at two years you're comparing obviously your sclerostin antibody to an active comparator versus these other agents which were compared to placebo I believe. So the question is should we be expecting, Sean, can you just talk about, is this an apples-to-apples comparison or apples-to-oranges comparison when we actually see that number? Thank you. Robert A. Bradway - Chairman, President & Chief Executive Officer: Sean, why don't you do romo and the Pfizer PCSK9 question, and then Tony can do part of it. Sean E. Harper - Executive Vice President-Research & Development: Okay. So with respect to room, what I would say is that you're right that this will not be so straightforward as to make cross-trial comparisons of those sort. They're fraught with difficulty always, these Santa Claus trial comparisons. But in osteoporosis,…

So I think that the payers will be looking at high-risk patients. Physicians will be making decisions around patients to prescribe that have a high risk. And I think the clinical trials we have will take into account all patients that are high-risk. Clearly those who have an event or have concomitant disabilities will be a higher chance of getting a drug and getting it prescribed.

Jake, let's take the next question.

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

Thank you. So when you look at Forteo sales, ex-U.S. sales are higher than U.S. sales despite limit of aggressive price increases. But when you look at Prolia, U.S. sales account for 64% of total sales. Why do you think that there is a difference in usage between anabolic and entire result of Asia, or so you think this is due to several of the administration versus efficiency of the administration (1:03:40)? And the follow-on, that is romosozumab is going to be used one-year treatment whereas the PTA channels are going to be used two-year in use, countries is two years. So how do you think about the pricing of romosozumab? Thank you.

Let me try and answer the first piece about the difference in the sales globally. I think Prolia was simply a timing around coming to market. We came to market during a fiscal crisis, and the entire reimbursement process outside the United States took a number of years. In fact, in France it took us 4.5 years from approval to get the final decision made on pricing. So outside the U.S. they are running to catch up in terms of the patient usage. And then we are sure that eventually we should get to a decent balance. Sean? Robert A. Bradway - Chairman, President & Chief Executive Officer: I think the other question... Sean E. Harper - Executive Vice President-Research & Development: Another question had to do with pricing. Robert A. Bradway - Chairman, President & Chief Executive Officer: Pricing, value, Tony? Sean E. Harper - Executive Vice President-Research & Development: I imagine it's premature.

I think the price we'll be able to charge will be clearly linked around the value proposition we see coming out of the clinical trials.

Okay, Jake, let's take the next question please.

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

Hey, good afternoon, guys. Thanks for taking my question. I wanted to go back to Kyprolis for a minute, and just wondering if you have an efficacy interim look built into CLARION similar to what you had for ENDEAVOR? And if you do, what triggers it? And what kind of action can be taken? Would it just be – it could be stopped for either futility or overwhelming efficacy? Thanks. Sean E. Harper - Executive Vice President-Research & Development: Yeah. So these trials were all designed more or less at the same time by the same group of people. And they all have a generally similar design in that they have interim analyses. Obviously, that interim analysis has in it the ability to stop the trial for clear futility and to stop the trial for overwhelming efficacy. And if you, I'm sure will recall, both ASPIRE and ENDEAVOR were stopped for overwhelming efficacy. I think this is a reasonable design. But I don't think that we are in any way planning on seeing a first-line study stopped for overwhelming efficacy at the interim, but it is a possibility. Robert A. Bradway - Chairman, President & Chief Executive Officer: As we said, Cory, we're expecting this in 2017. Okay, let's go to the next question.

And your next question comes from the line of Ying Huang from BofA Merrill Lynch.

Hi. Good afternoon, guys. Thanks for taking my question. If you don't mind, can you spell out the sales of Repatha last quarter? I know it's a small number, but just a housekeeping question there. And then secondly on romosozumab regulatory path, do you believe firmly that the first Phase 3 trial that would read out in 1Q this year should be sufficient for FDA approval? Thanks. Robert A. Bradway - Chairman, President & Chief Executive Officer: Sorry. Did you get the second question, Sean? Okay, why don't you go ahead in the second question? Sean E. Harper - Executive Vice President-Research & Development: Yes, on the romo study, yes, we believe based on the published guidances by regulators around the world and our interactions with the regulators around the world that if successful, the placebo-controlled study we were just talking about earlier, the first of these studies that reads out, will be sufficient for global registration. Robert A. Bradway - Chairman, President & Chief Executive Officer: Okay. And as to the Repatha sales, you're right, we're not breaking those out by line item at this time.

Jake, let's go ahead and move on to the next question, please.

And your next question comes from the line of Brian Skorney from Robert W. Baird. Brian P. Skorney - Robert W. Baird & Co., Inc. (Broker): Hey, good afternoon, guys. Thanks for taking the question. Just thinking a little bit more about the outcomes data for Repatha expected later this year, where do you think the range of outcomes can fall in terms of how we extrapolate the reduction in LDL capability of the drug to what we've classically seen in terms of CV reduction? And kind of maybe think about what the range should be based on that? And how it could deviate from that classical extrapolation, whether it's due to different types of patients or just the trial design? How we can think about that? Thanks. Sean E. Harper - Executive Vice President-Research & Development: Yeah. I mean this is the kind of subject than one can sit around and talk about for many, many hours with experts, which I've done. And I think the best thing I can say is that we have a remarkably linear relationship that we've established, most recently with IMPROVE-IT, extending that line in just a remarkably linear fashion. Extending the line that was created by statins and by other interventions, such as ileal bypass surgery and so on, and the genetics of course. And so when you put it all together, what you have to believe scientifically is that what the truth is, that you're going to fall right on that line in the same way as if you achieved that additional LDL lowering with a statin or with ezetimibe, were that possible. Obviously it's not. Could it deviate from the line? Sure. I mean it is always possible that some of the foibles of the way that the clinical trials are…

Lots to talk about today. So we have exceeded our prescribed hour, Jake. Why don't we take two last questions?

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

Good afternoon. This is Nick in for Jim this afternoon. We've spent a lot of time talking about the very late-stage pipeline, and clearly you've done a pretty impressive job developing those molecules. But what are you pointing investors to in terms of the early stage? If I look at the Phase 2 pipeline, half of those AMGs are with Astra. There's the CTEPH inhibitor that I guess you're all wondering what to do. And then many of those Phase 1 molecules have been around for a long time. So Phase 3 looks really good, but what about Phase 2 and Phase 1? What should we be focused on? Sean E. Harper - Executive Vice President-Research & Development: We're actually really excited. I think it's fair that we've had so much going on in the later stages that we haven't spent as much time focusing on talking about what's going on in the earlier pipeline. But we're really excited about quite a number of things in the earlier pipeline. Obviously, omecamtiv mecarbil is very exciting. We have the migraine, new migraine antibody PAC-1 that I mentioned. We have a novel heart failure molecule which will be entering in the clinic this year. That's something that we've developed in-house. We have a completely novel inflammation mechanism that no one else is pursuing that I think is extremely interesting that's entering Phase 1 now. And we have quite a range of bites (1:12:57) targets that are moving forward into the clinic either now or in the relatively near future. So I think there's plenty to look forward to in that space. And we also have earlier than that really the most exciting stuff, which is some of the targets that we believe we are uniquely working on because they've arisen from our advanced population-based human genetic efforts like this sort of Gene X example that some of you may recall from our business review, which is moving along very nicely. So I think in a future business review type setting we'll probably talk a little bit more. It's been hard to do that with everything that's been going on in the late-stage work.

Jake, let's take one last question, please.

And there are no further questions at this time, sir.

Okay, great. In that case, let me thank everybody for your participation in our call. Between myself and my team, we'll be around for a while. So if there are any other questions, feel free to call us. Have a good day.

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