My name is Ian and I will be you conference facilitator today for Amgen's Fourth 2019 Financial Results Conference Call. [Operator Instructions] I would now like introduce Arvind Sood, Vice President of Investor Relations. Mr. Sood, you may now begin.

Okay. Thank you, Ian. Good afternoon everybody. Thanks for joining us today. So 2019 was the year and that we made significant progress on our strategy and took steps that position us well for what will surely be a special year in 2020 as we celebrate our 40 anniversary. What better gift to celebrate this important milestone than to get back to revenue growth. So, our Chairman and CEO, Bob Bradway, will lead the discussion today. We are also joined today by our new CFO, Peter Griffith, who will provide a financial update on our results for Q4 and full year 2019 and provide guidance for 2020. Our Head of Global Commercial Operations, Murdo Gordon, will then review our product performance followed by our Head of R&D, Dave Reese, who will provide a pipeline update. We will use slides to guide our discussion today and you should have received the link separately. We will also use non-GAAP financial measures in today's presentation and some of the statements will be forward-looking statements. Our 10-K and subsequent filings identify factors that could cause our results, actual results, to differ materially. So with that, I would like to turn the call over to Bob. Bob?

Okay. Thank you, Arvind and good afternoon everyone and thank you for joining our call . Heading into 2020, we feel ready for the challenges of a new year and we're feeling encouraged by the progress we made in 2019. Once again, this past year, we met and exceeded our financial targets. We advanced key elements of our long-term growth strategy and we serve more patients around the world with our growing portfolio of medicines. 2019 was the transition year, we had long been preparing for as many of our off-patent legacy products faced new competition. I believe we managed this transition well, as evidenced by the fact that we delivered earnings growth in 2019 and will return to top line growth in 2020. In 2019, drug prices in the U.S. actually fell overall for the first time since 1974. In anticipation of this challenge, we re-positioned the company's expense base and embedded productivity initiatives over the past several years that are serving us well. In addition, we reshaped our product portfolio committing to medicines that can deliver growth for us primarily through volume increases rather than price increases. Products like Repatha, Aimovig, Prolia, Evenity, and most recently Otezla. In 2019, we delivered 3% volume growth globally and 19% volume growth outside the United States. We're seeing especially strong performance in our Asia-Pacific region, albeit from a small base. Over the next decade, we expect this region to account for as much as 25% of Amgen's growth. For the full year in 2019, volume in the region grew 62%. Over two-thirds of that growth came from our joint venture with Astellas in Japan, the world's third-largest pharmaceutical market. Just a reminder that this collaboration reverts fully to Amgen on April 1st, enabling us to do business in Japan, through a…

Thanks Bob. Let me begin by saying how happy I am to join Amgen at such an exciting time in the company's 40-year history. I also want to take a moment to thank, David Meline, the Amgen team, as well as many of you on the call who have helped me transition into the role. Over the last several months, I've enjoyed meeting many of our investors as well as members of the analyst community and I look forward to the continued dialog and engagement. Now, let's turn to the fourth quarter financial results on Page 6 of the slide deck. Revenues at $6.2 billion decreased 1% year-over-year in the fourth quarter. In the quarter, we saw worldwide product sales declined 2% to $5.9 billion as our portfolio transition with declines in our mature products substantially offset by our growth and launch products. We are particularly encouraged by the strong 21% volume driven growth from our ex-U.S. markets, which gives us confidence as we continue our global expansion including into China, which will also benefit from our collaboration with BeiGene, which closed earlier this month. Foreign exchange had a 1% negative impact to fourth quarter worldwide sales on a year-over-year basis. Other revenues at $316 million were up $87 million versus Q4 2018. Our Q4 non-GAAP operating income at $2.6 billion decreased 4% from prior year. Non-GAAP operating margin was 44.6% for the quarter, compared to 45.3% in Q4 of 2018. As previously indicated, our operating expenses reflected the typical underlining - underlying fourth quarter pattern, increased investment in our rapidly evolving oncology pipeline portfolio and additional operating expenses associated with the Otezla acquisition, which closed in Q4. These increases were partially offset by continued favorable expense impacts from our productivity initiatives across all operating expense categories. Other income and…

Thanks Peter, and good afternoon everyone. I'll take a few minutes to reflect on 2019 and then review Q4 in greater detail. In the 40 years since incorporation, Amgen's product portfolio and geographical footprint has changed dramatically. On our 40th anniversary, we reflect on the pioneering innovative spirit of our early Amgen employees that transformed the treatment of disease. Our mission to serve patients remains unchanged and it motivates us every single day. Our accomplishments on behalf of patients in 2019 give us further confidence about our future as we enter 2020. To summarize 2019, for the full year, we grew volume by 3%. The growing proportion of our portfolio posted 35% year-over-year volume increases. This portfolio is diverse and includes products such as Prolia, Evenity, Repatha, Aimovig, Otezla, Amgevita, our six hematology and oncology brands as well as MVASI and KANJINTI. Finally, our international business contributed 19% volume growth in 2019. Notably, year-over-year revenues for our businesses in China and Japan grew nearly 8 fold. These markets are long-term growth engines for Amgen and our collaboration with BeiGene along with our acquisition of Otezla will accelerate our expansions in the second and third largest pharmaceutical markets. Now moving to fourth quarter results. Volumes grew by 3% year-over-year. In Q4, net selling prices declined 4% year-over-year, resulting in reported net sales declining by 2%. As Peter mentioned, we have a stable outlook for our base business for 2020 and with the addition of Otezla, we expect revenue growth this year despite projecting continued declines in net selling price on a portfolio basis. Now getting into product details, Prolia delivered 15% growth year-over-year, driven by higher volume from increasing rates of new patient growth and strong repeat injection rates. Recall that given twice a year dosing, Prolia experiences consistent seasonal trends.…

Thanks Murdo and good afternoon everyone. As we enter 2020, we are looking forward to important clinical data from programs across our three therapeutic areas, inflammation, oncology, and cardiovascular disease. I'll say more about oncology in a moment, but I'd like to take the opportunity upfront to express our enthusiasm for the BeiGene collaboration. We're off to a good start and look forward to working together to advance the global development of our pipeline of innovative oncology molecules. I'll now begin my quarterly review in inflammation. We expect Otezla data this year from a Phase 3 study in over 500 patients with mild-to-moderate psoriasis that have failed topical therapy. This patient population has no approved oral therapy available and we are confident that Otezla may provide a much needed treatment option. We're working with the CHMP toward a Behcet's indication in Europe and with the FDA on inclusion of the scalp psoriasis data in the U.S. label this year. There are also ongoing studies for new indications, including pediatric psoriasis and we're evaluating additional studies to expand the opportunity for Otezla. I'll also remind you that later this year, we expect Phase 3 data from our TSLP antibody, tezepelumab in development with AstraZeneca and severe uncontrolled asthma. In bone health, along with UCB, we were pleased to receive European approval for Evenity for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture. Evenity is the first new osteoporosis medicine approved in Europe in the last decade, a testament to the need for a new therapy that can rapidly build bone. Turning to oncology and hematology, we continue to rapidly advance the development program for AMG 510, our first-in-class KRAS G12C inhibitor. We enrolled the potentially pivotal Phase 2 monotherapy study in advanced non-small cell lung cancer…

Okay. Thanks, Dave. Ian, why don't we open the lines up for questions now and please remind our callers of the process.

[Operator Instructions] Our first question is from line of Jay Olson from Oppenheimer & Co. Jay?

You talked a little bit about net pricing dynamics for Aimovig. Could you maybe elaborate a little bit on how you expect the competitive dynamic to shape up in the CGRP space and any long-term data, you could potentially leverage there? Thank you.

Thanks for the question Jay, it's Murdo here. We're very pleased with Aimovig's market access position now with over 92% of covered lives, having access to Aimovig at a very affordable co-pay. We're also pleased with the addition this year of CVS, last year we did not have CVS as a benefit - with Aimovig as a benefit. And we do as of the beginning of this year and we've already seen and acceleration in our new patient uptake. We are happy that the percentage of patients that are receiving paid prescriptions now of Aimovig is above 80%. And that bodes well for the future growth of this category because we've got highly effective medicines that have an impact, a significant impact on the reduction of migraine days on migraine sufferers. And we have a lot of them, there is 4 million eligible patients out there in the U.S. and they're able to access Aimovig at a very affordable co-pay. So that's good for the future outlook of the category. Obviously because we did contract to secure that additional access, there will be a reduction in our net selling price that you'll see in Q1 and then we expect it to be relatively stable over time. Now, because this is a retail benefit product, you do see some fluctuations, as you make true-ups in the mix of your product that comes through Medicaid commercial or to some extent Medicare Part B. But overall, we would expect post Q1 stability in net selling price.

And our next question is from the line of Michael Yee from Jefferies. Michael?

I had an R&D question for David. Of course there is a lot of attention on AMG 510, you made a lot of great comments about how you quickly enrolled the study and we're going to get data later this year. One of the things I picked up on was your comments about first-line lung? Can you just maybe make a comment about how that advances or how that progresses or how you go about a first-line strategy that's obviously a huge opportunity, so maybe just comment about where that monotherapy study goes and where you can go with first-line? Thank you.

Yes thanks, Michael. That is intended to provide a potential treatment option for patients who are not eligible for other first-line lung therapies or unwilling to take such therapies. I think it will provide incredibly valuable clinical information on response to the drug in a previously untreated population. We've just started enrolling that, so over the course of the year as we generate data, we'll provide guidance as to when we may have some things to share.

And our next question is from line of Chris Raymond from Piper Sandler. Chris?

Just on M&A priorities so Bob I was kind of struck a couple of weeks ago in San Francisco. You guys talked about renal as maybe an area of interest in terms of building out the pipeline and you're offering and obviously augmenting what is a pretty formidable business now. But I think the wording that I heard you say, Bob was that any asset you bring in, would have to be game changing. So maybe two parts can you talk about the reasoning for this sort of focus on renal or at least articulating that to us. And then what are you really looking for in terms of the game-changing therapy? Thanks.

Yes so, Chris just to remind you we have six commercial franchise areas, of which nephrology is one obviously that was our first. We've been a leader in that area now for several decades. We have a number of important products for nephrologists today and we intend to continue to serve the needs of patients and physicians and providers et cetera in that community. We have not found in our own discovery research efforts that we've been able to find the kinds of game changing innovation that we want to invest in from a discovery standpoint. So we're not investing in discovery research in nephrology right now, but we are going to look for business development opportunities there and in general our strategy when it comes to the business development is to look for medicines that make a big difference for patients suffering from these diseases. So we'll look for innovation and large effect size. I don't know that I use the word game changer. But if I did, that's what I was intending to reflect the notion of large effect size innovative medicines. So to the extent, there are some in the industry or otherwise medicines, where again we think because of the historical investment we've had it with this community patients’ that we can add real value, we'll look.

And our next question is from line of Brian Skorney from Robert W. Baird & Co. Brian?

One quick one - actually two quick ones on housekeeping, just it looks like compared to last quarter, you saw a 6% decline in Neulasta market share. Could you just breakout how much of that was Onpro loss and can you also talk about how Onpro price has been impacted by the biosimilars have been able to maintain price so far or have you taken greater discounts to maintain that share? Thanks.

Okay, those are good questions for Murdo. Why don't you go ahead Murdo.

Yes thanks, Brian. The majority of the share decline is from the prefilled syringe. Onpro exited at a 55% share of long-acting filgrastim and continues to hold up well in terms of share. We have had a contract out there that provides some discount to Onpro, but it's a more modest discount, then you would see on the prefilled syringe.

And our next question is from line of Evan Seigerman from Credit Suisse. Evan?

One on biosimilars so what are some gating factors to achieve, I think it's multi-billion or you had at one point said greater than $3 billion in sales across the franchise. And if there were to be implementation of an international pricing index for most favored nation clause for Medicare Part B. How would this potentially impact your biosimilars business? Thank you, guys.

I can take a stab at the first part of your question and Murdo, I invite you to jump in. But since we made those undertakings before you were part of the team Murdo. The notion that we articulated was that we were going to advance the portfolio of up to 10 biosimilars that we expected that these could be an attractive growth opportunity for the company and we're off to a good start, as you heard me say earlier. At the end of the fourth quarter, we are annualizing in excess of $1 billion. So we're off to a good start. We're on time. We're on budget with these programs and the gating item is simply product approvals and product launches. So we remain enthusiastic about our chance to earn a return from these products and it adds to the specifics of IPI, just to say in general. We obviously would be concerned we think quite a few other stakeholder groups would as well about the disruption that IPI would represent to the innovative biopharmaceutical industry. And we think there are better ways to evolve our system in a way that ensures patients have access to medicines at affordable prices, but Murdo feel free if you want to add anything specific about IPI in biosimilar landscape.

Nothing on IPI, Bob I think you summarized it well and on the biosimilars, the only thing I would say is I'm thankful to have inherited this portfolio and for the decisions that were made prior to my arrival. I think this is a strong business opportunity. It's been one, we've been able to realize very good competitive share in Europe and we're off to a very good start in our early launch in the U.S. And I look forward to being able to launch more products.

And our next question is from line of Kennen MacKay from RBC Capital Markets. Kennen?

I totally agree it was transformative. Maybe for Murdo, I was wondering if you could talk a little bit about the synergies you're seeing or expecting between selling of both Otezla and Enbrel and whether there were any tailwinds there to year end formulary rebating or contracting negotiations. We should think about in pricing or access in the year ahead?

Thanks for the question, Kennen. Yeah we're excited about potential synergies between Otezla and Enbrel, and quite frankly by extension our biosimilars business coming into the inflammation category. Too early to comment on specifics, but we continue to work through our contracting strategy, promotional strategy even things as simple as possibly expanding into primary care promotion because we have a fairly large primary care footprint. And then clearly, our international geographic expansion is augmented by having Otezla joining our portfolio with potential new markets where perhaps Otezla was slated to be launched by distributors when we have a full blown affiliate in some of those markets. And then the last pieces of course synergies as we go into some of the new indication areas. So I'm excited about building those. Our teams are working hard to realize those synergies, and I feel optimistic that we'll be able to be more specific in upcoming quarters.

And our next question is from line of Umer Raffat from Evercore ISI. Umer.

I am just extraordinarily confused today on the guidance, but I'll limit my question two specific things perhaps. First, Peter on the OINE line, if you can bear with me for a second, you mentioned $1.2 billion to $1.4 billion and I was trying to think it through and I thought to myself $30 billion debt at just above 3% rate, so that's $1 billion as an interest expense, minus about $100 million of the interest income. So that's $900 million, so when you guide to $1.2 billion to $1.4 billion, that's effectively implying $300 million to $500 million for BeiGene. But my understanding was you're only booking 20% and I'm just trying to understand is BeiGene's implied net income $1.5 billion to $2.5 billion or am I thinking about that wrong, because that sounds so much higher than what BeiGene does. That's number one. And secondly on revenues. I noticed - I know the business is being implied flat year-over-year outside Otezla, so I just want to understand better what the pushes and that pulls are there and perhaps also I think it mentioned biosimilars doing $1 billion in 2020 annual 4Q '19 alone was north of $1 billion run rate, so just trying to understand all this. Thank you very much.

Okay Umer. Let's try and go through that, I think there were three questions there. So Murdo, you want to take the first two on the revenue, just clarify what we said and then Pete, you can help clarify the other interest and expense line.

Sure. So yes, we have guided that our base business will be stable year-over-year, obviously there are a range of outcomes on that portfolio and we continue to work hard across a number of opportunities to do as we've done historically and that is to outperform. I would say that Otezla has come in and we have seen very good seamless integration of that team and that performance of that product and the growth trajectory continues with - without any interruption through the fourth quarter and we're seeing strong weeks early in the New Year. On biosimilars, it's very early in the launch of those two products, where we are annualizing as you pointed out at over $1 billion based on fourth quarter and we expect to be able to continue to accelerate that business.

Umer, Peter here. Thanks for your question. I would take you to the fact that our total debt at the interest rate I talked about in my remarks at 3.7% average maturity 12 years, by the way, I mentioned that too. That plus the 20.5% of BeiGene's results for 2020, the publicly available consensus estimates are what we're guiding to. So when you work through those two, you should get pretty close to our $1.2 billion to $1.4 billion for 2020.

And our next question is from line of Robyn Karnauskas from SunTrust Robinson Humphrey. Robin.

I don't want to beat a dead horse, but I guess I'm confused too just by this lack of growth given that your slides have outlined, Neulasta, you've lost like half Onpro's holding, you're growing like a bunch of different products. So what is the one thing you think that is going to prevent you from growing more this year and not just having a stable business year-over-year, like that's sort of what I'm struggling with the most, just help me understand that because the way you describe, it looks like more growth of the top line. Thank you.

Sorry Robyn, repeat the last piece - last piece of your question.

Sure. The way you're describing our your business is in your slide performance basically is that you're growing many parts of the business and the part that is declining is Neulasta, it seems to be potentially stabilizing with Onpro. So what is preventing you from growing beyond what you're guiding, is there one particular thing, I think most of us sitting there saying why can't you grow more than what you've outlined given the picture that you painted of the business being actually quite strong.

So I would agree with your last comment, the picture of the business does look quite strong. We're pleased with what we've been able to achieve, particularly in the back half of last year. As I mentioned earlier, some of the Neulasta stability with Onpro has been at the expense of contracted terms, which lowered the net price of that total portfolio inclusive of Onpro and we would expect with additional competitors against Neulasta in the biosimilar space that there will be further net price erosion in the long-acting filgrastim category and of course, overall in our total portfolio worldwide, we would expect single digit net price declines for the year. Now, that goes up against what I talked about throughout the call is we have a number of really strong growth drivers in a young portfolio, very diverse products, and we have guided a wide range on revenue and it's my hope that the strong execution we saw in the back half of last year continues into this year and we can achieve a good growth profile, not just in Otezla but in the base business.

And our next question is from line of Terence Flynn from Goldman Sachs. Terence.

Omecamtiv is a product you guys haven't talked a lot about recently obviously some Phase 3 data coming later this year, Dave, you mentioned it in your, in your remarks as well in terms of kind of the change in treatment landscape, but just curious if you could remind us of the puts and takes for the program, as we think about the probability of success here and what would really get you guys excited that type of data? Thank you.

Sure Terence. This is Dave. I'm happy to address that. I mean, as I mentioned in my remarks, heart failure is a global epidemic, what makes us continue to have excitement in omecamtiv, it's a first-in-class mechanism of action, it's the only drug ever introduced that actually acts directly on the heart cell to improve contractility or the heart's pumping function and we're conducting what'll will be a definitive 8200-patient or give or take trial in patients with advanced heart failure, it's a fairly sick population, where we're going to be looking for mortality benefit and a variety of other clinical outcome measures that improve. So I think there is a large amount of residual unmet medical need and obviously where this fits in a train changing treatment landscape will depend on the profile that emerges from that Phase 3 trial.

And our next question is from line of Ronny Gal from Bernstein Research. Ronny.

Good afternoon and congratulations on the nice 2019 and got one housekeeping and one question. The quick one is, I was wondering if you could give us your comment on the Medicaid block grant that just was announced today. Does that has any relevance to you and then generally, where do you expect it will impact the drug industry. And second, David, I was wondering if you could give me your - your view on the modest lung catering paper suggesting in the targeting the active GDP bound form of KRAS is better than trapping the GDP KRAS in the inactive form in terms of preventing tumors and tumor resistance to those agents.

Good. Well let me - I'll knock off the Medicaid piece first Ronny, for those who are on the call who aren't aware, CMS released some guidance earlier today, so we and others are still chewing through it. I think you'll have very limited impact at first read of it for us, but it's likely to be relevant for those states that didn't opt into the ACA in the first instance and we'll go through it as well, I'm sure others in our industry, more closely to see whether there are any specific issues, for our business, but it didn't seem to me Ronny that that was going to be a concern for us in 2020. Dave, you want to tackle the one please.

Yes. I'm sure you don't want to address that one, Bob. So, we look - for those who aren't familiar, Ronny's referring to paper that came out within the last month or so that suggests that also targeting the GDP bound form of KRAS G12C would be required for signaling inhibition. We read the paper with interest, of course, I'll make a couple of observations. First, I would say our own data with AMG 510 suggest that at the appropriate doses and doses that we can achieve clinically, we can completely suppressed signaling throughout a dosing interval. It is also my understanding or belief that the G12C inhibitor used in that paper may have been a little less potent and one thing that we've learned over 40 years in oncology is that if you in completely inhibitor target, you very quickly breed resistance. So I would say, I feel very confident based on the preclinical data that we've generated with AMG 510 and we're of course profiling tumors across our clinical program to try to generate signatures of response and resistance. This is the sort of thing that we'll look at. But I don't see anything in the literature as of yet that dissuades me from the approach we're currently taking.

And our next question is one of Mohit Bansal from Citi. Mohit.

And a quick question on Otezla in mild-to-moderate psoriasis, it seems like you will have data later this year, but given that net of tax rate is kind of a standard of care in that particular market and is a generic, what sort of challenge do you anticipate placing baseline in that market and how do you think about navigating those challenges there? Thank you.

Yes. Well, let me start Mohit and then I'll ask Murdo to jump in. So in mild-to-moderate psoriasis, there are currently no approved oral therapies. The only thing really available to patients right now is topical therapy, many of them will not ultimately experience disease control with those topical therapies and so we think there is a real opportunity for Otezla in that area. There are up to nearly 6 million patients with mild-to-moderate psoriasis in the United States alone. So that gives you a sense of the size of this opportunity and actually the prevalence of the disease. Murdo.

Yes and Mohit, the only thing I would add is, yes, there is some methotrexate use there, but it's largely a topical business as Dave described and it's largely a patient population that gets very little relief. And this is really a patient population that is in the sweet spot for Otezla. The other thing I have to say is that our new colleagues when building out their positioning strategy for Otezla and their payor strategy have done a very, very nice job of positioning the access and reimbursement for Otezla as a post topical pre-biologic option. So I think for the mild-to-moderate population if we're successful in securing that indication that same payor strategy will be continued. So, I feel confident that we're in good shape there for another source of growth for Otezla going forward.

So Ian, I know we've got several calls or several questions still queued up, so we will try to get through those apologies that were beyond the top of the hour here, but let's go onto the next question.

Certainly. Our next question is from line of Matthew Harrison from Morgan Stanley. Matthew.

I just wanted to follow up on a comment that Dave made earlier in the call, suggesting I think that - that maybe you're seeing some activity in HLE-BiTE in both solid tumors and liquid tumors. Maybe you could just characterize for us what - what data you have internally that gave you the confidence to make that statement? Thanks.

Yes. Thanks, Matt. And I assume that someone would pick up on that statement. So what I would say is, I'm not ready to declare victory in any indication yet, but we're seeing the sort of pharmacodynamic activity and early suggestions of anti-tumor activity that are reminiscent of the early days of BLINCYTO and that give us encouragement that we're on the right track. I'd also point out that we undoubtedly have the largest experience in the world in development of bispecific T-cell engagers, as I noted in my remarks, we've learned an enormous amount about dosing and scheduling appropriate management of adverse events and I think all of that is starting to come to bear right now and we're starting to see some of these hints in that in the HLE or half-life extended format. So again, I'm not ready to declare a victory, but we're seeing signs of encouragement and we'll be ready to share some of those data as the year goes on.

And our next question is from line of Do Kim from BMO Capital Markets. Do.

Just one on Aimovig, you've talked previously about expanding the primary care prescribing base. How would you go about doing that and could you do it with your current sales force?

Yes. Thanks, Do. We - we are doing it with our current sales force. I think I talked about the 33,000 prescribing base and I think we're seeing some encouraging results, right now in the CGRP class, you see about 7,000 new patients coming into the class and into the category that are receiving a CGRP therapy and it's our goal to broaden that given that there are so many patients, who are persisting on oral therapies and older therapies that are just not as effective and in fact we see very high drop off and very low persistency on these older oral meds like topiramate and we are trying to change that care continue on that pathway in the way physicians treat chronic migraine sufferers and I think we're having some success. So the 7,000-patient per week number that we're seeing is one that we're looking to grow and we are applying all the right efforts, both in our digital campaigns as well as our personal selling teams in the primary care community right now. So yes, the answer is, we have all the resources required to do that.

And our next question is from the line of Yaron Werber from Cowen & Company. Yaron?

If you don't mind, Dave, just have a quick housekeeping and then a question for Murdo. On the housekeeping side, Omecamtiv, can you just let us know is there one more final DSMB look before you look at the event rate, and then for Murdo just curious about Repatha, it looks like it's beginning to grow now. But now, what's your expectation given that 70% of patients that have access to the new price - the new formulation. Thank you.

Yes Yaron, so I'll take the Omecamtiv question. There is an -- as we've previously discussed, there is an interim analysis for efficacy that will occur, that has a very, very high bar, a very high bar in terms of the statistical stopping rule. So our expectation is that the trial will continue through to the primary analysis towards the end of the year.

Yes. And Yaron, on Repatha just a reminder, a 100% of patients are accessing the low-list price because we pulled the original list price off the market in December. And we've been able to throughout the course of 2019, open up the commercial access where the majority of patients receive Repatha by their physicians prescribing it without the need for paperwork and utilization management criteria, so physician attestation only in commercial is the majority condition for how they can prescribed Repatha. And then in Medicare Part D space, obviously that's a new event for us, because we were mid-cycle when we lowered the price with the introduction of the low list price. So it's really something we're excited about as an accelerating potential for Repatha, as was mentioned roughly 70% of Medicare Part D lives now have access to Repatha at an affordable co-pay. So we're looking forward to seeing sustained growth going forward. Our teams are ready and I was just with our sales forces in Dallas and everybody is pretty excited about being able to treat more patients quite frankly the way they should have been treated all along.

And our next question is from line of Geoffrey Porges from SVB Leerink. Geoffrey.

A quick housekeeping and then one for Murdo. First, could you just give us an update Dave on where the C5 biosimilar program is, is that still active and then for Murdo - Murdo, I'm impressed with the Evenity number, you're annualizing it sort of $350 million already, which I think is better than most of us anticipated. Could you talk a little bit about the reception you're receiving and whether you really think this can become Forteo's obviously losing its exclusivity, can it become a Forteo-like brand given what you're seeing already? Thanks.

Yes. Jeff, so I'll take the first part of that question relating to ABP 959 or Soliris biosimilar, the Phase 3 is actively enrolling and we'll provide guidance as we come to the conclusion of that trial when you can expect to see data.

Yes. And Geoffrey, thanks for the question on of Evenity. We are pleased with the launch trajectory on Evenity, it's reflective really of two markets, Japan and U.S. primarily. The Japanese launch has been nothing short of a resounding success out there with our partners, Astellas and UCB, I think physician reception has been excellent. We positioned the product for post-fracture high-risk patients and I think that that's gone really well and it's where the risk benefit equation seems to be one that most physicians are accepting off and we've done the same thing in the U.S., our launch is a little younger in the U.S., but nonetheless the trajectory has exceeded our own expectations as well. We just recently got our permanent J code in the U.S. and that's opening up the prescriber base as well. So I do think that we will have a very successful franchise on our hands and of course UCB will be commercializing with some help from us across Europe, thanks to the approval with the EMA there. So overall, whether - will it be as big as a Forteo that remains to be seen. We are - I will remind you slightly less expensive 30% on the low-end as much as 70% on the high end than our competitors in the category, it's a 12-month duration so it's not a product that you take for multiple years, it's for of 12-month duration, but the new patient acquisition is clearly exciting.

And our next question is from line of Alethia Young from Cantor Fitzgerald. Alethia?

I guess part of that has been another drug that's been doing quite well in spite of Sensipar. So maybe can you talk about should we expect continued kind of unit demand growth. I know you probably had some contracting obviously over the prior 12 months. But just maybe help us frame how to think about the next 12 months for parts of it. Thanks.

Yes, thanks, Alethia. The Parsabiv performance last year was fantastic. There are a number of patients, who are benefiting from it. There is a change in reimbursement for Parsabiv going into coming into 2020 that may slow the rate of growth a little, but the range of Parsabiv outcomes is broad and it's really too early to call. A – Bob Bradway: Okay, Ian, I think we've got two more calls we try to get them and then we'll wrap up.

Very well. Our next question is from line of Salim Syed from Mizuho Securities. Salim?

Just one for me on Omecamtiv, David, you mentioned that the landscape will be changing believe on and some of the recent data. And I guess what I was looking for some clarity on when I presume you're talking about the SGLT2 space specifically flows in and then from the commentary you provide, are you envisioning this to be on the Omecamtiv to be on top of SGLT2s or competing at the head and if there is any patients actually getting enrolled in the trial. Thank you.

Yes, thanks Salim. Yes, so I was making reference to the SGLT2s in particular, our sense is that the patients treated in those studies were probably a somewhat less sick population. So that may be a point of differentiation and then as we have intended all along with our Omecamtiv given the lack of drug-drug interactions that we've seen now in the mechanism of action. It is intended to be an add-on to other therapies. Of course, in the Phase 3 trial, we will look at number of patients, who are receiving things such as SGLT2s in the study.

Okay, let's get the last question.

And our final question is from line of Cory Kasimov from JPMorgan. Cory?

Hi, this is Gavin on for Cory. Thanks for fitting us in. I apologize if you answered this, but we are wondering what your assumptions are going into the double-digit growth for Otezla. Does this imply a label expansion or is this just with the existing label and or any comment on competitive concerns. A – Bob Bradway: And I think we've addressed that. But we just reiterate for you Gavin, what we think is behind that. A – Dave Reese: Yes. So we are assuming that we would secure additional indications in our assumption for double-digit going forward. We're also using historical growth rate and where we're sourcing a new patients right now. So I think that's pretty clear.

Okay, everyone. Thanks for your patience. Sorry. We went a little bit past the allotted hour, but let me just conclude by saying that we feel good about where we ended in 2019 managing through what was always going to be a transition year for us, and we think we're on the cusp now of a period of new product revenue growth. So we look forward to that. And we look forward as well to important clinical data that is expected particularly towards the second half of this year. So I'd be remiss if I didn't just take a moment to thank as well the Amgen staff around the world, who continue to work so hard every day to deliver on our mission to serve patients. So thank you to them. And we look forward to let me chance to talk to all of you in April after the first quarter.

Thanks Bob. Thanks everybody for your participation. If you have any other questions you would like to cover, of course myself, and the rest of the IR team will be around for several hours. Have a good day.

Ladies and gentlemen, this does conclude Amgen's fourth quarter 2019 financial results conference call. We thank you for joining us. You may now disconnect.